MAY 2 017

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BeasleyAllen.com I. 2 nd U.S. Circuit Court of Appeals that should hope to break. Each recall notice General Motors remains responsible for means hundreds, thousand or millions of CAPITOL injury, death, and diminished-value claims people have been put at risk of serious OBSERVATIONS that occurred before its 2009 bankruptcy. injury or death. No example better high- The lower court found that GM was still lights the potential risk than the Takata responsible for the older claims because it airbag recall, which has identified 46 knew about the ignition switch defect for million airbag inflators for repair and The Atlanta Office more than a decade but concealed it from affected approximately 29 million the bankruptcy court and its customers. vehicles. We opened our Atlanta office in January nd GM appealed the 2 Circuit Court’s The National Highway Traffic Safety of this year and things have gone very ruling and contended that “well-estab- Administration (NHTSA) estimates only well. We should have made this move lished bankruptcy law allowed the newly about 13.6 million of the 46 million defec- years ago. Nevertheless, we are glad to be reorganized GM to obtain the old compa- tive airbags have been repaired, leaving there now and to be a part of the Georgia ny’s assets ‘free and clear’ of liabilities.” millions driving cars with a defective air- legal community. Chris Glover will head GM began recalling about 2.6 million vehi- bag—a product meant to protect drivers’ up the office and Navan Ward will also be cles in 2014 over the deadly defect, which lives—that could literally explode in their there on a permanent basis. Gibson Vance, allowed the ignition to be jostled into the faces during an accident if it is exposed to Parker Miller and LaBarron Boone have off or accessory position with the vehicle high temperatures or humidity. The recall also spent a great deal of time in the in motion, causing it to lose power steer- Atlanta area. Our plan is to expand the ing, speed, anti-lock brakes, and airbag office as things progress. protection. These faulty ignition switches IN THIS ISSUE Since moving to Atlanta, Chris Glover caused hundreds of GM cars to crash. The has been actively exploring the area, I. Capitol Observations...... 2 GM ignition switch defect has been liked making new connections and building to 124 deaths and 275 injuries. The auto- relationships in the legal community. II. More Automobile News Of Note. . . . 2 maker has already paid about $2 billion to Recently, Chris was asked to serve on the settle civil complaints and criminal Georgia Trial Lawyers Association (GTLA) III. Purely Political News & Views. . . . .5 charges in connection to the ignition Executive Committee. The GTLA is the switch debacle. IV. Court Watch...... 5 only association in Georgia committed nd The 2 Circuit’s ruling reversed a ruling exclusively to serving the needs of plain- by a U.S. bankruptcy judge in 2015, who V. The Corporate World...... 6 tiffs’ lawyers. drew a line between the liabilities of the The executive committee is the govern- pre-bankruptcy “Old GM” and the post- VI. Whistleblower Litigation ...... 8 ing body of the GTLA, which meets bankruptcy “New GM.” This effectively monthly. Chris will have a vote in issues VII. Product Liability Update ...... 10 shielded the “New GM” from any claims affecting the GTLA membership and also involving vehicles and accidents before its has been asked to oversee the GTLA VIII. Mass Torts Update...... 12 June 2009 bankruptcy. The Supreme Public Relations/Communications Court’s refusal to hear GM’s appeal is most Committee. IX. Business Litigation...... 16 significant. GM will face at least 1,000 We really look forward to working with additional lawsuits. lawyers in Georgia on matters of mutual X. Insurance and Finance Update . . . .16 Beasley Allen and The Cooper Firm rep- interests. Having Lance Cooper with us in resented individuals and families through- XI. Employment and FLSA Litigation. . . 17 Georgia is very important. We have been out the country who were harmed by the working with Lance on product liability ignition switch defects in GM vehicles. XII. Premises Liability Update...... 17 cases for years. We, working with Lance Cooper, settled a large number of cases with GM last year. XIII. Workplace Hazards...... 18 Our lawyers welcome the opportunity to XIV. Transportation...... 20 II. work with lawyers on any GM ignition switch cases. For more information about XV. Environmental Concerns...... 21 MORE how this recent ruling may affect claims, AUTOMOBILE contact Beasley Allen lawyer Dana XVI. An Update On Class Action Litigation. .24 Taunton at 800-898-2034 or by email at NEWS OF NOTE [email protected]. XVII. The Consumer Corner...... 27 Sources: Bloomberg, Associated Press and Law360. com XVIII. Recalls Update...... 30 GM’s Bid To Block Ignition-Switch Suits Rejected By U.S. Supreme Court XIX. Firm Activities...... 36 Automakers Installed Defective Takata GM has lost its bid to bar hundreds of XX. Special Recognitions...... 37 Airbags With Knowledge Of Defects ignition-switch lawsuits when the U.S. XXI. Favorite Bible Verses...... 37 Supreme Court refused to hear the auto- Last year automakers recalled 53.2 maker’s appeal claiming it isn’t liable for million vehicles in the United States. It is a XXII. Closing Observations...... 38 pre-bankruptcy filings. The Supreme record that has been broken annually Court left intact last year’s ruling by the since 2014, though it’s not exactly one we XXIII. Parting Words...... 39

2 BeasleyAllen.com has been a messy one: Not enough criminal case against Takata. The auto- The settlement called for the creation of replacement parts exist to fix all the previ- maker agreed earlier this year to refund the restitution funds, and also required ously affected cars. But what about new $975 million and pay a $25 million crimi- Takata to improve its compliance program cars? You would think a recall on Takata nal penalty as part of a settlement with and to appoint an independent monitor airbags would mean they were no longer the U.S. Department of Justice (DOJ). who will report to the DOJ for three years installed in vehicles coming off the assem- Judge Steeh wrote in his order that after about Takata’s compliance with legal and bly line—but you would be wrong. conducting “exhaustive research” and ethical obligations. A little more than a Defective airbags linked to the largest “meeting with three potential candidates,” year ago, NHTSA levied a $200 million consumer recall in history were still being he selected Mueller—a former FBI director fine on Takata—its largest ever—in a deal placed in new cars long after their dangers and former U.S. attorney—to serve as in which the company admitted that it became apparent. That was because some special master for the restitution fund. failed to tell the agency about the defect had yet to be recalled and so they could Judge Steeh said that Mueller’s back- even though it knew about it and held still technically be installed. A June 2016 ground suggests he is “uniquely qualified” important information. NBC News piece reported automakers Fiat to oversee the settlement fund. The NHTSA estimated at the time that the Chrysler, Mitsubishi, Toyota, Daimler court’s order states: exploding inflators had caused about 98 Vans, Ferrari, Mercedes-Benz and Volk- injuries. A sprawling multidistrict litiga- swagen were at some point knowingly The court determines that Mr. tion involving injured victims and people using defective Takata airbags that had not Mueller is the best candidate for the whose car values have decreased is been equipped with desiccant, a chemical position, based in part on the pending in a Florida federal court. Takata designed to reduce moisture, in new cars. parties’ support of his appointment, is one of the defendants. The case is U.S. v. People bought cars not realizing they as well as the court’s comfort and Takata Corp. (case number 2:16-cr-20810) would soon be recalled—and the manu- trust in his impeccable credentials, in the U.S. District Court for the Eastern facturers knew the parts they were install- his relevant experience in settlement District of Michigan. negotiations, his familiarity with ing had been linked to people’s deaths. It Source: Law360.com seems like a far cry from trying to protect the automotive industry in general, consumers. and based upon his well-known rep- To make matters worse, a shortage of utation for integrity. Volkswagen Agrees To $157 Million replacement parts not only means Ameri- Mueller and his team will be in charge Settlement Over States’ Emissions Claims cans continue to travel with defective of determining what entities and individu- airbags, but last year federal regulators als should be paid out, and in what Volkswagen AG, Audi AG and Porsche approved installing defective Takata infla- amounts, from two separate funds — AG ey have agreed to pay a total of about tors as replacements for older airbags in $850 million for automakers, and $125 $157.45 million in penalties to 10 states to about 2.1 million recalled vehicles. million for individual consumers. Judge resolve environmental claims stemming “Federal regulators have approved (the) Steeh wrote that Takata must pay the $850 from the companies’ emissions cheating move as a temporary measure due to a million within five days of its sale or scandal, as well as some consumer claims shortage of replacement parts using merger, which must occur by Febru- that weren’t covered in a prior settlement. newer, safer designs,” NBC News ary 2018. The companies and their American subsid- explained in its 2016 article. Takata’s air bag inflators have been iaries reached a settlement to end environ- A better way has to be found. America linked to at least 11 deaths in the U.S. and mental claims brought by Connecticut, should be striving to create safer vehicles caused the largest auto recall in the Delaware, Maine, Massachusetts, New that require fewer recalls—not switching nation’s history. Takata has faced massive York, Oregon, Pennsylvania, Rhode Island, out one potential disaster for another or global recalls of its air bag inflators, which Vermont and Washington over their use of continuing to allow manufacturers to have a tendency to explode. In February the defeat devices to hide the true levels install products they know are defective. the company pled guilty to one count of of nitrogen oxides being emitted by pur- Some records should never be broken. wire fraud in the Michigan federal court as portedly “clean” diesel vehicles. The set- If you need more information on the part of its plea deal with prosecutors over tlement also ends consumer protection Takata airbag litigation contact Chris the company’s falsifying of testing data claims by the states for injunctive relief or Glover, a lawyer in our Atlanta office, at and reports about its inflators. The settle- restitution concerning the companies’ 404-751-1162 or by email at Chris.Glover@ ment resolved the DOJ investigation into affected cars that feature 3.0-liter diesel beasleyallen.com. the company and its affiliates. engines, claims that were not included in Sources: NBC News and NHTSA That same day, the DOJ made a super- the $603 million settlement agreed to last seding filing that charged Takata with the year with 44 states, Washington, D.C., and one wire fraud count it to which it agreed Puerto Rico. Former FBI Director Selected To Handle $1 to plead guilty. The scheme started some- The settlement also requires Volkswa- Billion Takata Fund time around 2000 and ran for at least 15 gen to offer at least three new electric car years. Takata fraudulently persuaded cus- models across its brands, including two Former FBI director Robert Mueller has tomers to buy air bag systems by giving electric SUVs, by 2020—something it had been selected U.S. District Judge George them false information, hiding the accu- previously committed to doing in Califor- C. Steeh by a Michigan federal judge to rate test results for the air bag inflators. To nia. The states included in the latest settle- administer the nearly $1 billion Takata further that plan, Takata made an inter- ment have adopted California’s strict Corp. has agreed to pay automakers and state wire transfer of about $43,000 from vehicle emissions standards pursuant to consumers who purchased its defective Pennsylvania to Detroit, according section 177 of the Clean Air Act. California air bag inflators. Steeh is overseeing the to the DOJ. has the unique authority to set its own

JereBeasleyReport.com 3 emission standards, so long as they meet U.S. Environmental Protection Agency expanded recall, but it said that a door or exceed federal standards. Other states (EPA) and the California Air Resources opening while driving increases the risk that cannot develop their own standards Board (CARB) in September 2015 had of injury. can adopt those laid out by California. accused Volkswagen of using the defeat New York Attorney General Eric T. devices to evade federal emissions tests • Ford said it had received 29 reports of Schneiderman’s office, in a news release, for diesel vehicles. fires in the U.S. and Canada, though no said that this marks the first time that the As we have previously stated, Volkswa- injuries. The company said that it will states have won environmental penalties gen has admitted fault and said that the mail customers instructions from the from an automaker under their state software came preloaded in millions of its owner’s manual on how to check and vehicle emission laws. The release said: diesel vehicles around the world—nearly refill coolant. “Customers can continue 600,000 of which were sold in the U.S.— to drive their vehicles, but should see Historically, enforcing vehicle emis- allowing the vehicles to emit more toxins their dealer if their vehicle exhibits a sion standards has been done pri- into the air after they left testing labs and coolant leak, overheating or frequently marily by the federal government. were out on the roads. A number of Volk- needs coolant added,” Ford said. “When Setting this precedent is particularly swagen executives have also become service kits are available, dealers will vital now, when President Trump caught up in the debacle. install a coolant level sensor with sup- has vowed to defund federal envi- The MDL is In re: Volkswagen “Clean porting hardware and software at no ronmental enforcement and undo Diesel” Marketing, Sales Practices and charge to the customer.” federal environmental protections, Products Liability Litigation, (case which would leave states like New • In September, Ford doubled the size of number 3:15-md-02672) in the U.S. Dis- the door latch recall at the time when it York and California as the first line trict Court for the Northern District of of defense for the environment. added about 1.5 million cars, bringing California. the total to more than 2.3 million. The Volkswagen characterized the settle- Source: Law360.com original recall, launched in August, only ment in a news release as avoiding affected owners in 16 states that gener- “further prolonged and costly litigation as ally have higher ambient temperatures Volkswagen continues to work to earn Volkswagen Ordered To Pay $2.8 Billion In and solar loading, including Arizona, back the trust of its customers, regulators Criminal Fines California, Florida and Texas. Dealers and the public.” Under the settlement, the will replace all four side door latches money will be allocated as follows: In a related matter, last month a Michi- with a more robust service door latch gan federal judge ordered Volkswagen AG for free, according to Ford. The • Connecticut receives about to pay a $2.8 billion criminal fine for expanded recall continues the automak- $14.85 million, cheating emissions standards. This came er’s door latch woes, having recalled • Delaware about $1.45 million, six weeks after the German automaker for- nearly 3.3 million vehicles over issues mally pled guilty to the three criminal with faulty pawl spring tabs since 2015. • Massachusetts about $20 million, charges connected to the scandal. U.S. District Judge Sean Cox sentenced the • In the other recall, about 230,000 cars • Maine about $5.16 million, automaker to pay the fines pursuant to a are at risk for under-hood fires, accord- ing to Ford. In those cars—Ford Escape, • New York about $32.53 million, settlement agreement with the U.S. Department of Justice and U.S. Customs Ford Fiesta ST, Ford Fusion and Ford • Oregon about $16.22 million, and Border Protection. Transit Connects from model years 2013 to 2015 with 1.6-liter GTDI engines — a • Pennsylvania about $30.43 million, lack of coolant circulation could cause an engine to overheat and crack the cyl- Ford To Spend $295 Million On Fire Risk • Rhode Island about $4.1 million, inder head. “A cracked cylinder head And Door Latch Recalls • Vermont about $4.24 million and can result in a pressurized oil leak,” Ford said in a statement. “Oil that comes Ford Motor Co. has announced two into contact with a hot engine surface • Washington about $28.42 million. recalls—one for a fire risk, and another for increases the risk of a fire in the engine a door latch problem—covering about The 10 states’ claims against Volkswa- compartment.” gen have been wrapped up in multidistrict 440,000 cars in North America. In a secu- litigation (MDL) over the emissions rities filing, Ford says it expects to spend The first recalls came in January 2015 scandal and, under the settlement, many around $295 million to fix the issues. The with 205,000 Ford Taurus sedans. Ford of their cases will be remanded back to following is a brief statement relating to announced a second, separate recall of state court for settlement purposes. The the recalls: 213,000 Ford Explorer and Police Inter- ceptor SUVs in March 2015. The auto- settlement is subject to court approval. • The first recall includes 211,000 2014 maker launched another recall in April Volkswagen pled guilty in March in a model year Ford Fiesta, 2013-14 Ford 2015, covering 390,000 model year 2011 to Michigan federal court to conspiracy to Fusion and 2013-14 Lincoln MKZ cars 2014 Ford Fiestas and 2013 to 2014 Ford defraud the U.S., wire fraud and Clean Air that may have faulty latches, resulting in Fusion and Lincoln MKZ vehicles. Ford Act violations as part of a deal with the a door that can’t close, according to the added 156,000 of the same vehicles to the U.S. Department of Justice (DOJ). The set- automaker. This expands a previous recall a week later. The automaker dis- tlement with the DOJ and U.S. Customs recall of 2.3 million vehicles over this closed the estimated cost of the recalls in and Border Protection, initially reached in issue, according to Ford. The automaker a filing with the U.S. Securities and January, also contains measures to fortify said it is not aware of any accidents or Exchange Commission. the company’s compliance systems. The injuries related to the cars in the

4 BeasleyAllen.com In January 2016, the National Highway counsel, with Berger & Montague PC and IV. Traffic Safety Administration (NHTSA) Zimmerman Law Offices PC as class launched an investigation after the agency counsel. Ford has agreed to pay up to $8.9 COURT WATCH received nearly 75 complaints over faulty million in attorneys’ fees and costs. door latches on model year 2012 and 2013 The proposed class is represented by Ford Fiestas. The agency closed the inves- Jordan L. Lurie, Tarek H. Zohdy, Cody R. Neil Gorsuch Joins U.S. Supreme Court tigation in October, saying that the recall Padgett and Karen L. Wallace of Capstone addressed the safety risks posed by the Law, Russell D. Paul of Berger & Montague Tenth Circuit Judge Neil Gorsuch has door latches. and Thomas A. Zimmerman Jr. of Zimmer- become a member of the U.S. Supreme man Law. The case is Omar Vargas, et al., Court. The new justice was confirmed by v. Ford Motor Co. (case number 2:12-cv- the Senate by a 54-45 vote, with only three Ford To Settle Fiesta And Focus Class 08388) in the U.S. District Court for the Democrats voting in favor of President Action With Cash And Credits Central District of California. Donald Trump’s nominee. The new justice Source: Law360.com fills the seat vacated in February 2016 by Ford Motor Co. has agreed to provide the death of Justice Antonin Scalia. Justice “substantial cash payments” and “other Gorsuch will create a 5-4 majority on the benefits” to the owners of about 1.5 court for Republican appointees and will million of its Fiesta and Focus models that III. definitely put an end to the 4-4 deadlocks had to be repaired due to malfunctioning PURELY POLITICAL that have occurred since Justice Scal- transmissions. The settlement covers ia’s death. owners and lessees of 2011 to 2016 Ford NEWS & VIEWS Gorsuch, age 49, is the youngest sitting Fiestas and 2012 to 2016 Ford Focuses. Supreme Court justice since Clarence Ford did not oppose the Plaintiff’s motion Thomas. When nominated, Gorsuch was for preliminary approval of the settlement. The Senate Race In Alabama serving as a very active judge on the The alleged malfunctions included vehi- United States Court of Appeals for the cles that slipped, bucked, kicked or jerked It appears that there will be a hotly con- Tenth Circuit. He had been appointed by while the driver attempted to accelerate. tested race for the U.S. Senate seat in President George W. Bush and confirmed Ford will provide a private arbitration Alabama left vacant when Jeff Sessions without opposition in the Senate. Hope- program through which consumers will because U.S. Attorney General. Former fully, Justice Gorsuch will be fair and be able to get the automaker to repurchase Attorney General Luther Strange was follow the law, and especially the Consti- or replace defective vehicles. It’s esti- appointed by Gov. Robert Bentley before tution, during his time on the high court. mated that resolution of claims will take his resignation to fill the vacancy. A one to two months, but the program’s special election to fill the rest of the term rules also authorize repurchase or replace- will be held on Aug 15. A good number of The President Cuts The ABA Out Of ment of any vehicle that has endured four serious candidates will oppose Luther in Federal Judge Vetting Process attempts to fix its transmission hardware his bid to keep the seat. within five years or 60,000 miles and that I don’t believe a stand-alone primary The American Bar Association (ABA) still doesn’t work. helps Luther and it may actually hurt him. has been told by the Trump administra- The program also extends the statute of It will be interesting to see who all runs. tion that the White House will be break- limitations for claims to six years after the At press time for this issue in addition to ing from a long-standing practice of issue arose or six months after the effec- Luther, Judge Roy Moore, Rep. Ed Henry having the group evaluate district and tive date of the settlement, whichever is and Dr. Randy Brinson were the only circuit judge candidates. ABA president later. Consumers who prevail in arbitra- other announced candidates. Others Linda A. Klein released a statement saying tion will be awarded $6,000 in attorneys’ waiting in the wings include Sen. Del that the group has been told by the White fees, while those who lose will be able to Marsh and former lawmaker Perry House that the current administration will appeal the finding to a second panel. Ford Hooper. Interestingly, Henry and Hooper not be inviting the ABA’s independent will receive no fees or appeals rights were the Trump Campaign Managers Standing Committee on the Federal Judi- under the agreement. Class members who for Alabama. ciary to review the professional qualifica- believe they have either been improperly Most political observers say the turn out tions of potential nominees for the lower charged for repairs or denied repairs that in August will be very low. I predict it will federal courts before they are nominated. should have been covered under Ford’s be a record low. I don’t believe any of the I believe the ABA evaluations are impor- new vehicle limited warranty can also candidates will get enough votes to avoid tant and should be given a place in the pursue these claims through a more a run-off. This race will be most nominations and confirmation of limited arbitration process. interesting! federal judges. Ford will cover the cost and if the con- Source: Law360.com sumer is successful, they will receive free repairs or warranty extensions and be reimbursed for out-of-pocket costs. The Supreme Court Rejects $2.7 Million Plaintiffs are also seeking to appoint 18 Goodyear Discovery Sanction class representatives who will each receive between $1,000 and $10,000, sep- The U.S. Supreme Court has thrown out arate and apart from any benefits they get a $2.7 million fine levied against Goodyear as part of the settlement class. Capstone Tire & Rubber Co. for what a federal judge Law APC wants to be named lead class

JereBeasleyReport.com 5 had called “deliberate misconduct” in ishing the party that committed the V. failing to produce a key test in a motor misconduct. The court said: vehicle crash lawsuit. This was a case THE CORPORATE focused on the authority of judges to set To level that kind of separate WORLD fines over litigation misconduct, Goodyear penalty, a court would need to successfully challenged an Arizona district provide procedural guarantees court decision that the company and two applicable in criminal cases, such as of its lawyers should pay the sanction to a a “beyond a reasonable doubt” stan- The President Kills Government family that sued the company, but settled dard of proof. When (as in this case) Contractor “Blacklisting” Rule on the eve of trial without ever seeing a those criminal-type protections are President Donald Trump has signed a very important test. The Supreme Court missing, a court’s shifting of fees is Congressional Review Act resolution declined to set a new award and left it to limited to reimbursing the victim. rolling back the Fair Pay and Safe Work- the lower court to reconsider the possibil- The limits of compensating only costs places rule. This was the rule that requires ity that Goodyear has waived its ability to related to the wrongdoing were governed bidders for federal contracts to disclose challenge $2 million of the sanctions fine. by a “but for” test, or whether the miscon- their labor law violations. The signing of In her opinion, Justice Elena Kagan, duct led to legal work that would not have the bill makes permanent a preliminary writing for the high court, said that such to have been done anyway. The results of injunction blocking the government from orders should be restricted to “the fees the the tire test definitely should have been enforcing the rule’s new reporting innocent party incurred solely because of provided to the Haegers. Would that have requirements on federal contractors and the misconduct. The opinion said: caused Goodyear to settle the case much subcontractors, which had been set to A district court has broad discretion earlier? In any event, the Haegers con- take effect in October. to calculate fee awards under that tended that the fees against the company The contractor rule, called the “black- standard. “But because the court should be justified “for any moment past listing rule” by opponents who say it here granted legal fees beyond those when the test should have been unfairly smears companies alleged to have resulting from the litigation miscon- disclosed.” violated labor laws, requires potential duct, its award cannot stand.” The high court disagreed with the federal contractors and subcontractors Haegers, however, noting the existence of bidding on any federal deal worth more Three Defendants—Goodyear, onetime defenses that Goodyear would still have than $500,000—with the exception of Goodyear local counsel Fennemore Craig been able to use, including claims about contracts for commercial off-the-shelf PC lawyer Graeme Hancock and coordi- the age of the tires on the Haegers’ items—to disclose violations of labor laws nating counsel Basil J. Musnuff—chal- vehicle. The court explained its decision going back three years. The rule was lenged the lower court’s decision. The as follows: enacted in August by the Federal Acquisi- Haeger family were seriously injured tion Regulatory Council with accompany- Further, the Haegers cannot demon- when a tire on their motor home blew, ing U.S. Department of Labor guidance strate that Goodyear’s nondisclosure causing their vehicle to crash. The family and an underlying 2014 executive order. so permeated the suit as to make sued the tire maker and settled the case. The executive order stated at the time: During the next year, the Haegers’ that misconduct a but-for cause of lawyer read an article mentioning a rele- every subsequent legal expense, Contractors that consistently adhere vant Goodyear tire test that had not been totaling the full $2.7 million. If to labor laws are more likely to have produced in their case. A motion for sanc- nothing else, the district court’s workplace practices that enhance tions was filed on behalf of the Haegers. back-up fee award belies that theory. productivity and increase the likeli- hood of timely, predictable, and sat- The trial court judge concluded the test While the lower $2 million award from isfactory delivery of goods and should have been produced in response to the district court was said to have more services to the federal government. the Haegers’ first document request, and carefully considered which expenses found Goodyear, Hancock and Musnuff were caused by Goodyear’s misconduct, Under the rule, those disclosures of vio- had engaged in “blatant discovery fraud.” the Supreme Court said it was unclear lations and whether they purportedly The trial court judge ultimately imposed whether the court took into account “the show “serious, repeated, willful or perva- sanctions on Hancock for $550,000 and right standard” in calculating that award. sive” labor law violations would be taken jointly against Musnuff and Goodyear for In its May petition to the Supreme into account by contracting officers when $2.2 million. The judge also imposed a Court, Goodyear argued that its due determining whether to award or extend “contingent award” of $2 million, in case process rights were violated when the contracts. Construction and security the $2.7 million award was rejected by the trial court judge levied what the company industry groups sued to block the rule a Ninth Circuit. Fees incurred by the said amounted to “a criminal sanction few weeks before it was set to take effect Haegers relating to demonstrating medical untethered from the discovery problems.” in October. A Texas federal court was told damages and against other defendants It should be noted that Musnuff and that the Obama administration exceeded were subtracted from the total. The Ninth Hancock settled with the Haegers in its authority in issuing the rule. The oppo- Circuit affirmed the district court’s penal- October and were not parties in the case nents said the rule imposes “new regula- ties in 2015 in full. at the time of Supreme Court oral argu- tory burdens on government contractors The Supreme Court said the standard ments. The case is The Goodyear Tire & that exceed and contradict Congress’ care- governing civil procedure sanctions was Rubber Co. v. Haeger et al. (case number fully balanced labor and employment law limited to compensating the party disad- 15-1406) in the Supreme Court of the statutory scheme.” vantaged for the conduct, rather than pun- United States. U.S. District Judge Marcia Crone Source: Law360.com blocked the rule’s reporting provision and

6 BeasleyAllen.com another portion that prohibits pre-dispute Co. Ltd. and a $10.3 billion purchase of Certus was founded in 2011 by former arbitration agreements between contrac- USA Networks Inc., that put the company Bank of America and Wachovia execu- tors and workers covering Title VII allega- $18 billion in debt and led it to the brink tives, who sold a group of hedge funds on tions and sexual assault or harassment of bankruptcy. Before going to trial in the idea of starting a holding company to torts. The CRA resolution rolls back the 2009, the court certified a class of inves- buy up failing Southeastern community rule’s final provision requiring contractors tors from the United States, France, banks in the wake of the financial crisis to give workers detailed paycheck infor- England and the Netherlands who pur- and turn them around. The federal govern- mation including the number of hours chased Vivendi common stock or Ameri- ment was providing charters at the time they worked, their rates of pay and their can depositary shares between that qualified holders for lucrative federal gross pay. The House of Representatives 2000 and 2002. support like the ability to bid on failed passed the rollback bill by a nearly 50-vote In January 2010, a New York jury found banks at Federal Deposit Insurance Corp. margin in early February, and the measure Vivendi liable for the alleged misstate- auctions. narrowly passed the Senate. ments and, in December 2014, U.S. Dis- It was contended by the shareholders It’s very difficult to understand why cor- trict Judge Shira Scheindlin entered partial that Certus was one of only five banks to porations seeking federal contracts judgment on the bulk of the class claims, receive the so-called shelf charters, shouldn’t have to disclose information that awarding $49.7 million in damages and making it a “government-backed business relates to their past performance involving interest. Vivendi took that ruling to the venture that should have been an easy safety issues. What am I missing? It would Second Circuit, arguing that the investors winner.” However, under the terms of the appear that workplace safety would be presented no actionable claim of securi- charter investors were required “to accept paramount and important to both the ties fraud and that the company’s state- the unfettered control of the Certus board Trump White House and Congress. ments were nonactionable opinion, and management” and were prevented Source: Law360.com “puffery” or forward-looking statements. from initiating proxy fights. Certus bought But in September, the Second Circuit two failed Georgia banks in 2011, but rejected Vivendi’s arguments, saying that quickly began running up an enormous shareholders had presented enough evi- corporate tab “for [executives’] own per- $26 Million Settlement Ends Vivendi’s dence to the jury to prove Vivendi was sonal enjoyment, while projecting an 15-Year-Old Investor Suit liable for the $49.7 million in damages. image of glamour and opulence,” the origi- Vivendi SA has agreed to pay $26.4 The appellate court stood by that ruling nal complaint said. million to settle all remaining disputes in in November when it declined to rehear By April 2014, the bank had lost nearly an almost 15-year-old case alleging that it the case. Vivendi was primed to petition $170 million and was under investigation falsely reported “better than expected” the Supreme Court to review the Second by the South Carolina Attorney General’s financial results after making a series of Circuit decision, even getting Justice Ruth office. In June 2015, the bank sold off acquisitions that led it to the brink of Bader Ginsburg to grant an extension of nearly all of its remaining assets and in bankruptcy. The settlement, which is time to file a petition for a writ of certio- November 2015 some of Certus’ hedge subject to court approval, was filed in rari until April 10. fund investors filed suit, alleging breach of New York federal court on April 6. This The shareholders are represented by fiduciary duty, waste and other claims. closes the book on a Second Circuit appeal Arthur N. Abbey and Stephen T. Rodd of Certus entered into a $110 million lease and a possible petition for the U.S. Abbey Spanier LLP. The case is In re for 160,000 square feet of office space in Supreme Court to hear the case. Vivendi Universal, S.A. Securities Litiga- Greenville, South Carolina, in 2011, The money will go to 96 investors who tion (case number 1:02-cv-05571) in the although the board had only authorized appealed to the Second Circuit two New U.S. District Court for the Southern Dis- them to lease 20,000 square feet total, the York federal court rulings that granted trict of New York. complaint says. summary judgment for Vivendi. As a Source: Law360.com The hedge funds are represented by Joel result, those shareholders, clients of Friedlander, Christopher Foulds and Chris- investment managers Capital Guardian topher P. Quinn of Friedlander & Gorris PA and Mark Lebovitch, Christopher J. Trust Co. and Southeastern Asset Manage- Investors Reach $20 Million Settlement Orrico and John Vielandi of Bernstein ment, couldn’t collect damages because Over Holding Bank’s Failure the trial court said the companies hadn’t Litowitz Berger & Grossman LLP. The case actually relied on the alleged misstate- A group of hedge funds have reached a is 3-Sigma Value Financial Opportunities ments when trading Vivendi’s stock. If $20 million settlement in Delaware Chan- LP, et al. v. Milton Jones, et. al., in the those 96 clients had prevailed in the cery Court with the former executives and Court of Chancery for the State Second Circuit, they could have been enti- board members of defunct CertusBank. It of Delaware. tled to $79 million, about three times was claimed that the bank’s leadership Source: Law360.com more than the amount offered in the set- spent tens of millions of dollars on frivo- tlement. The appeal was withdrawn after lous expenses, ran the bank into the the settlement, which, if approved, will ground and then destroyed documents in Raymond James To Pay Investors $150 completely end all claims in the long-run- an effort to cover up their wrongdoing. Million Over Jay Peak Fraud ning litigation. The settlement was reached after months Investors sued the French media con- of intense discovery efforts by the hedge Raymond James & Associates Inc. will glomerate in 2002, alleging that it misled funds’ lawyers. It should be noted that the pay $150 million in settlement of a suit investors about its finances after making a bank’s only recoverable asset was a $50 accusing two Vermont ski resorts of mis- series of acquisitions, including a $30 million insurance policy and it was being appropriating the bulk of $350 million billion buyout of Canada’s The Seagram rapidly depleted by litigation. obtained through the EB-5 immigrant

JereBeasleyReport.com 7 investor program. The parties said this set- that the settlement allows it to share in number 3:14-cv-01395) in the U.S. District tlement would facilitate project comple- the proceeds of certain third-party recov- Court for the Middle District of Florida. tion or the return of funds. The suit, eries the receiver may obtain. The inves- Source: Law360.com pending in the Southern District of tors will continue with the case against Florida, alleged Raymond James and Quiros and People’s Bank. The SEC has former branch manager Joel Burstein con- also brought a separate action against BlackBerry Awarded $815 Million In spired with Ariel Quiros, owner of the Jay Quiros and Stenger. Arbitration Peak and Q Burke ski resorts in northern The investors are represented by Vermont; Jay Peak CEO William Stenger; Thomas A. Tucker Ronzetti, Harley S. An arbitration panel has ordered Qual- and People’s United Bank in a Ponzi Tropin, Dyanne E. Feinberg, Rachel Sulli- comm Inc. to pay $815 million plus attor- scheme to cheat 836 foreign investors out van, Maia Aron and Tal J. Lifshitz of neys’ fees and interest to resolve a dispute of at least $200 million of the funds raised Kozyak Tropin & Throckmorton LLP; Paul with Blackberry over a patent license for improvement projects. Aiello, Michael P. Bennett and Jeremy R. agreement. Details of the arbitration are That money was invested through the Kreines of Bennett Aiello; Daniel C. Girard being kept private because of government, EB-5 program, which provides green cards and Adam E. Polk of Girard Gibbs LLP; and class action and licensee lawsuits involv- to foreign nationals who invest at least Kathleen M. Donovan-Maher, Steven But- ing Qualcomm licensing practices that are $500,000 in an American project that tacavoli, Mark A. Delaney and Nathaniel L. still pending. According to a statement creates at least 10 U.S. jobs. Tucker Ron- Orenstein of Berman DeValerio. The case issued by Qualcomm, the arbitration zetti, of Kozyak Tropin & Throckmorton is Daccache et al. v. Raymond James & decided only the narrow issue of whether LLP lead interim class counsel, stated: Associates Inc. et al. (case number 1:16- BlackBerry was entitled to refunds of roy- cv-21575) in the U.S. District Court for the alties on phone and chip modem sales that We are pleased that our lawsuit and Southern District of Florida. the work of the receiver resulted in exceeded per-unit caps. The refunds Source: Law360.com an excellent outcome for the inves- covered sales from 2010 through 2015. tor class. It will help ensure inves- It was reported that conditional rebates tors can keep their green cards in are one of the “licensing strategies” that projects where that is possible, or Rayonier Will Pay $73 Million To Settle has been getting Qualcomm in trouble receive a rapid return of funds Stock-Drop Suit with overseas antitrust regulators. A class where that is not possible, so they action complaint had been filed in January may quickly invest in other viable Forestry company Rayonier Inc. will pay in the Northern District of California. EB-5 projects. $73 million to settle claims that it misled This case is an example of the proper investors about its timber inventory and place for arbitration involving opposite The lawyers pointed to several benefits inflated its stock price until the truth parties with virtually equal power and in the proposed settlement, which was came out in late 2014. The suit was filed strength. That’s never the situation when reached in conjunction with Michael I. after Rayonier restated its earnings and arbitration is forced on a consumer who Goldberg, the court-appointed receiver for disclosed that it had been overstating the has a dispute with a large corporation. Jay Peak and its related entities. In amount of timber it could harvest and Source: Scott Graham, The Recorder exchange for resolving Raymond James & would be scaling back its logging in the Associates’ portion of the litigation, the Pacific Northwest to a more sustainable financial company, which is a subsidiary pace. The case was pending before U.S. of Raymond James Financial Inc., will District Judge Timothy J. Corrigan when VI. provide a $150 million fund that the it settled. WHISTLEBLOWER receiver will use under a proposed plan to The investors said the settlement would complete certain construction projects or help shareholders who bought the stock at LITIGATION to provide full principal refunds to inves- inflated prices over a period of nearly four tors no longer eligible to receive green years. The settlement was said to be the cards through these projects or where the second largest securities deal ever reached Bill Aims To Improve Incentives And projects are no longer feasible. in the Middle District of Florida. WellCare Protections For IRS Whistleblowers Goldberg, the receiver, said in a state- Health Plans Inc.’s $200 million settle- ment, that includes $67 million that will ment, announced in 2010, was the largest. A bi-partisan bill introduced in the U.S. be used to return the $500,000 principal Rayonier said in a statement in this case Senate proposes two key measures to investment each investor made in the Jay that the settlement would be covered by improve the IRS whistleblower program. Peak Biomedical Research Park LP. The its insurers. Senators Chuck Grassley (R-Iowa) and Bill receiver, according to the statement, will The Plaintiffs are represented by Maya Wyden (D-Ore.), founding members of the also be able to satisfy the claims of trade Saxena, Joseph E. White III, Lester R. Senate Whistleblower Protection Caucus, vendors and contractors. Hooker and Brandon T. Grzandziel of produced the IRS Whistleblower Improve- According to filings the company made Saxena White PA, David R. Stickney, Jona- ments Act of 2017 to enhance communica- with the U.S. Securities and Exchange than D. Uslaner, Niki L. Mendoza, Brandon tion between the IRS and whistleblowers Commission (SEC), the $150 million Marsh and Jenny Barbosa of Bernstein and strengthen legal protections for whis- includes $4.5 million that Raymond James Litowitz Berger & Grossmann LLP, and tleblowers facing retaliation from employ- has already paid in a settlement with the Robert D. Klausner of Klausner Kaufman ers for disclosing tax fraud. state of Vermont, and the balance will be Jensen & Levinson. The case is In re: Ray- Whistleblowers who have called out tax paid in two installments of $90.7 million onier Inc. Securities Litigation (case abuses to the IRS have expressed frustra- and $54.8 million. The company said it tion and anxiety over the agency’s han- had accrued $50 million as of Dec. 31 and dling of their tips, and especially when it

8 BeasleyAllen.com comes to updates about the status of their ers and computer system analysts. The • The company is not paying the H-1B case. Because anxiety over blowing the third highest recipient group of H-1B visas worker the wage certified on the Labor whistle can be exacerbated by silence, the are computer programmers, and that Condition Application. bill would allow the IRS to exchange infor- group was the topic of the March 31, 2017, Sources: www.uscis.gov and Gould, C. Lance. mation with whistleblowers to aid an memorandum. Whistleblowers: A Brief History and a Guide to Getting investigation. It would also require the IRS The March memorandum is USCIS Started. to provide whistleblowers with status response to the H-B1 visa fraud which has updates involving each significant devel- been taking place across the country. The opment in the review process. most common fraud scheme involves mis- Oklahoma Hospital Pays $1.6 Million To The proposed bill seeks to protect whis- classification. This is where an employer Settle False Claims Act Lawsuit tleblowers from backlash for standing up classifies the employee as a lower level to fraud and abuse. That is a giant obstacle graphic programmer, yet the programmer The Norman Regional Hospital Author- whistleblowers face. The bill aims to is performing the duties of a senior engi- ity in Norman, Oklahoma, a former hospi- extend the anti-retaliation provisions neer. Lower level programmers earn the tal administrator, and six radiologists have afforded to whistleblowers by other laws, entry-level salary. When that lower level agreed to pay the U.S. government more such as the False Claims Act and the Sar- programmer is a foreign national, the than $1.6 million to settle a whistleblow- banes-Oxley Act, to IRS whistleblowers. entry salary is around 40 percent below er’s False Claims Act lawsuit. It was Tax whistleblowers can be easily identi- the average industry salary for American alleged that the Defendants improperly fied within their companies because they workers. This type fraud not only goes billed Medicare for radiological services have specific knowledge of tax fraud. against the purpose of the H-1B visa, but it that did not qualify for reimbursement. Senators Grassley and Wyden said also lowers the average wage in the indus- The $1,618,750 settlement resolves the extending protections that exist in other try for senior-level jobs. That’s because suit filed in federal court in Oklahoma laws and statutes to tax whistleblowers is foreign nationals are performing the same City by Dr. Lance Garber, a radiologist for- not just a matter of fairness to all U.S. tax- senior-level jobs, but at entry-level pay. merly employed by Norman Regional. Dr. payers who pay taxes honestly, it’s also in USCIS responded by clarifying that an Garber filed the lawsuit under the whistle- the nation’s best interest to protect these entry-level computer programmer position blower provisions of the False Claims Act, valuable whistleblowers. Robert Patten, would no longer generally qualify as a spe- which authorizes private individuals to President and CEO of Taxpayers Against cialty occupation position, which is sue on behalf of the federal government. Fraud, stated: required for the H-1B visa. This requires The U.S. Department of Justice (DOJ) employers to provide other evidence to investigated Dr. Garber’s claims and These amendments will significantly establish that the particular position is a elected to back the lawsuit. strengthen the fraud-fighting poten- specialty occupation. Whistleblowers Dr. Garber and the U.S. alleged that tial of the IRS Whistleblower statute have played, and will continue to play, a Norman Regional and the other Defen- and promote the public-private part- large role in uncovering H-1B fraud as dants were billing Medicare for diagnostic nerships that the law was originally companies continue to recruit foreign services performed by radiological practi- enacted to foster. In particular, the nationals in attempt to pay entry-level tioner assistants (RPAs) without the anti-retaliation provisions will salary for senior-level duties. required supervision of physicians. The encourage more citizens to come USCIS has provided five indicators that U.S. Attorney for the Western District of forward and will result in the recov- could point to possible H-1B fraud. These Oklahoma said in a statement: ery of significant funds that would indicators are: otherwise be lost to tax fraud. There are certain radiological diag- • A wage disparity between the H-1B nostic services that require ‘per- Andrew Brashier, a lawyer in our firm’s worker and the other workers perform- sonal’ supervision. This means that Consumer Fraud & Commercial Litigation ing the same duties. Especially when a physician must be in the room Section, handles cases involving whistle- the company is paying the H-1B worker supervising the RPA when the RPA blower claims. You can contact him at a much smaller salary. performs the service. If a physician 800-898-2034 or by email at Andrew. is not in the room, the service [email protected]. • The H-1B worker is not performing the cannot be billed to Medicare. duties assigned in the H-1B petition. Especially when the duties performed Dr. Garber will receive $291,375, about H-1B Visa Fraud Ripe For Whistleblower are a higher level than the description 18 percent of the settlement, as a whistle- Litigation of the position. blower award for helping the U.S. recover the Medicare funds. The Defendants also • The H-1B worker has less experience The U.S. Citizenship and Immigration agreed to pay more than $31,000 for Dr. then the U.S. workers in the same Services (USCIS) issued a memorandum Garber’s legal expenses. position. on March 31 rescinding the Dec. 22, 2000, Source: U.S. Attorney’s Office for the Western District “Guidance memo on H1B computer • The H-1B worker is not working in the of Oklahoma related positions.” The government imple- locations certified on the Labor Condi- mented the H-1B visa program to help U.S. tion Application. companies recruit foreign nationals skilled Oxygen Equipment Provider To Pay $11.4 in specialized areas, specifically for times Million To End FCA Suit when there is a shortage of highly skilled workers in the U.S. The majority of H-1B A California company that provides recipients are computer software develop- oxygen tanks to people with breathing

JereBeasleyReport.com 9 problems has agreed to pay $11.4 million Beasley Allen Whistleblower Litigation highest auto defect verdict ever issued in to resolve a whistleblower claim that it Team the state. In its appeal, Honda claimed a and its general partner violated the False Pennsylvania Supreme Court case, Claims Act by submitting improper claims Because of the increased activity in Tincher v. Omegaflex, required the trial to federal health care programs. Braden False Claims Act (FCA) litigation, our firm Judge Shelley Robins-New to have granted Partners LP, which does business as formed a Whistleblower Litigation team a new trial. But Judge Alice Beck Dubow Pacific Pulmonary Services, allegedly last year. This has allowed our firm to said in the Supreme Court’s opinion, “We sought reimbursement from Medicare, handle this type litigation better and I find that the trial court, even in light of Tricare and federal employee health bene- believe our clients have and will continue Tincher, properly instructed the jury and fits programs for home oxygen and to benefit by this move. precluded certain evidence.” oxygen equipment that was supplied in Are you aware of fraud being commit- On Appeal Honda depended on what it violation of those programs’ rules. ted against the federal government, or a claimed were faulty jury instructions. The The settlement resolves those claims state government? If so, the FCA can company pointed to the finding in the against PPS and its general partner, Teijin protect and reward you for doing the right Tincher case that in design defect cases, Pharma USA LLC. Other claims involving thing by reporting the fraud. If you have juries—rather than judges—must deter- sleep therapy equipment supplied as part any questions about whether you qualify mine whether a product is unreasonably of a kickback scheme with sleep clinics as a whistleblower, contact a lawyer at dangerous. Honda argued that by engag- were also settled. “Home oxygen equip- Beasley Allen for a free and confidential ing in a risk-utility calculus, Judge Robins- ment and related supplies are some of the evaluation of your claim. There is a New was the one who made this deter- most fraudulently billed items of durable contact form on the firm’s website. mination, and that as a result of this, the medical equipment,” Steven J. Ryan, the You can contact one of the lawyers on company deserved a new trial. The Supe- special agent in charge from the U.S. our Whistleblower Litigation Team: Archie rior Court, however, looked at the jury Department of Health and Human Ser- Grubb, Larry Golston, Lance Gould or instructions in the trial and concluded vices’ Office of Inspector General, said in Andrew Brashier. You can call them at that they demanded the jury engage in its a statement. “Medicare suppliers more 800-898-2034 or reach them by email at own risk-utility calculus. Judge Dubow concerned with profits than compliance [email protected], Larry. said: will be met with investigation and [email protected], Lance.Gould@ enforcement.” beasleyallen.com or Andrew.Brashier@ Although the language in this The government says the improper beasleyallen.com. You can also contact charge—that there was an ‘alterna- conduct began in 2004 when PPS started Beasley Allen for a free copy of Lance tive, safer, practicable design’ for the submitting claims to federal health care Gould’s book, “Whistleblowers: A Brief seat belt restraint system—is not programs for home oxygen and oxygen History and a Guide to Getting Started.” precisely the language required for equipment without getting a doctor’s the risk utility analysis, we conclude authorization, which the programs that the charge is not fundamentally require. Two years later, some of the com- flawed. The portion of the charge to pany’s employees then began to refer VII. determine the ‘practicability of an patients to sleep testing clinics in PRODUCT alternate design’ inherently requires exchange for those clinics’ promise to the jury to balance factors such as refer their patients to PPS for sleep LIABILITY UPDATE the cost of implementing the design therapy equipment. Brian J. Stretch, U.S. against the relative safety of the attorney for the Northern District of Cali- alternate design. $55 Million Seat Belt Defect Verdict fornia, said in a statement: Honda argued that Judge Robins-New Upheld Patients in federal health care pro- did not properly instruct the jurors on the grams expect and deserve medical The Pennsylvania Superior Court last question of crashworthiness. The care that is free from any undue month upheld a $55 million jury verdict company said the judge failed to charge influence and complies with the against Honda Motor Co. It was alleged the jury on Martinez’s responsibility to program safeguards that are in that Honda ignored a seat belt defect that a show what injuries, if any, would have place to protect patients. driver claimed led to his becoming para- come from an alternative, safer design for lyzed in a rollover. The Supreme Court a seatbelt, and that she also failed to The suit was initially filed in 2010 by a found that a trial court judge did not err in charge them on whether Martinez proved former PPS sales representative, Manuel her jury instructions. The appeals court certain injuries were attributable to the Alcaine, who will receive $1.824 million rejected Honda’s arguments that a key flawed design. But the appeals court con- of the recovered money. The case is Pennsylvania Supreme Court decision cluded that the jury instructions did not Alcaine v. Braden Partners LP, et al. (case updating the state’s tort law issued after require the level of specificity demanded number 4:10-cv-04597) in the U.S. District the verdict but before post-trial motions by Honda. Court for the Northern District of should have compelled the judge to order The 2014 verdict in favor of Martinez California. a new trial. Plaintiff Carlos Martinez sued included $25 million for noneconomic Source: Law360.com the automaker in 2011, alleging he became damages such as pain and suffering, $14.6 a quadriplegic after his 1999 Acura Integra million for future medical expenses, $15 rolled over. million for his wife’s loss of consortium In June 2014, a Philadelphia jury issued and $720,000 for lost future earnings. the $55 million verdict against Honda, Martinez is represented by Stewart J. which Martinez’s lawyers called the Eisenberg and Daniel J. Sherry Jr. of Eisen-

10 BeasleyAllen.com berg Rothweiler Winkler Eisenberg & Jeck to lawyers. To order your copy or down- Few Plaintiffs in the pending lawsuits PC and Howard Bashman. The case is load a digital copy, visit benbaker- specifically cited “taper lock” as an issue, American Honda Motor Co. Inc. v. Marti- law.com/book. the panel wrote in its order. Instead, they nez et al. (case number 445 EDA 2015) in Source: Los Angeles Times allegedly experienced problems with cor- the Superior Court of Pennsylvania. rosion and metal debris, according to the Source: Law360.com JPML, which will allow non-recalled hip implant devices to be included Stryker Hip Implant Lawsuits Head To in the MDL. Boston Multidistrict Litigation Commercial Truck Tires Must Be Up To Par Source: Lawyersandsettlements.com To Protect Public Safety On The Roads Dozens of Stryker hip implant lawsuits have been consolidated in a Massachusetts Commercial truck tires must be safe and federal court so that the cases can be Machine Guarding & Industrial Safety dependable and that’s because these tires handled by one judge. The U.S. Judicial have a lot riding on them; people’s liveli- Panel on Multi-District Litigation (JPML) Some of the most common and often hoods and even lives depend on their agreed on April 5, 2017, to transfer nearly times severe on the job injuries occur proper functioning. As The Los Angeles three dozen pending cases related to when machine operators are injured by Times reported, the commercial trucks alleged defects in Stryker-branded LFIT industrial equipment. As most know, driving down the interstate could even be Anatomic CoCR V40 femoral heads, a pros- those injured on the job are often entitled carrying nuclear bombs. But nuclear thetic hip replacement device, to U.S. Dis- to workers’ compensation benefits. bombs or not, making sure that commer- trict Judge Indira Talwani in the District of However, the inquiry as to what remedies cial tires are up to their tasks is a must for Massachusetts. As we have previously are available to an injured employee the safety of truck drivers and the public. stated, the federal court system uses multi- should not stop there. All too often, other Tire problems cause about 8,000 accidents district litigation (MDL) as a tool to consol- viable claims related to the design and per year for commercial trucks alone, idate multiple similar cases focused on a manufacture of the machine in question Righting Injustice previously reported. particular argument to one judge for pre- are over looked. These accidents account for about 6 trial discovery. As long as heavy machines have been in percent of all commercial truck accidents. Most of the pending Stryker implant existence, injuries stemming from the use The National Highway Traffic Safety lawsuits focus on corrosion of the LFIT of those machines have also been around. Administration’s (NHTSA) Office of V40, which can lead to serious health con- Over the years machines have become Defects Investigations recognizes a sequences and necessitate surgery to safer. Greater safety awareness, better number of factors that can compromise remove and replace the hip implant, engineering, and other technological tire safety and increase the risk of a deadly according to the transfer order. The Defen- advances have certainly helped reduce the accident. As a result, the Federal Motor dant in the cases opposed consolidation likelihood of injury. Guarding against Carrier Safety Administration (FMCSA) has on the grounds that there are “only a few hazards is just one of many ways to elimi- issued a list of recommendations for com- actions” regarding the device. However, nate on the job injuries, and is an ever- mercial truck drivers to help promote tire the JPML disagreed, noting that around 33 evolving practice. safety. According to the FMCSA, commer- Stryker hip replacement cases in 17 differ- When a hazard within a machine is cial tires should be examined every day ent districts are pending. identified, there are typically three for irregular treadwear, cracking, bulges, In August 2016, Stryker issued a volun- options available to mitigate that hazard. inadequate tread depth, cuts and other tary recall on some hip implant devices The safety engineering hierarchy gives damage. Tire rims should only be those of after Stryker received “higher than machines designers a series of steps to an approved width and diameter, as mis- expected complaints of taper lock failure” take evaluate to mitigate a given hazard. matched tire and rim components for specific lots of certain sizes of LFIT The design engineers can: may explode. Anatomic CoCr V40TM Femoral Heads Overloading or underinflating tires manufactured before 2011. • redesign the machine to completely causes excessive heat build-up and inter- In the current MDL, Stryker had eliminate the hazard, nal structure damage, and exceeding tires’ requested that the Boston MDL be • guard against the hazard, or speed ratings can also cause damage and renamed from “In re: Stryker Orthopae- lead to tire failure. Hundreds of deaths and dics LFIT V40 Femoral Head Products • warn the user of the hazard. thousands of injuries from tire failure Liability Litigation” to “In re: HOC LFIT should motivate preventative action but, V40 Taper Lock Litigation” and also The preferred method for dealing with a sadly, manufacturers and employers often wanted to restrict the MDL lawsuits to hazard is to, when possible, redesign the refuse to take the necessary tire safety recalled hip implant devices with taper machine so as to totally eliminate precautions until their carelessness is lock failure. However, the JPML disagreed. the hazard. revealed in a courtroom. The transfer order stated: When a machine poses a hazard that Ben Baker, a lawyer in our Personal cannot be completely eliminated, the Injury & Products Liability Section, has We decline to change “Stryker” to appropriate course of action is to guard had a great deal of experience in handling “HOC” because defendant marketed against the hazard. If a hazard cannot be claims involving tire failure. For more the device to physicians under the eliminated or guarded against, the final information, contact him at 800-898-2034 Stryker brand name. We also decline course of action is to develop adequate or by email at Ben.Baker@beasleyallen. to change the title to add “taper warnings alerting the user of the hazard. com. Ben recently wrote a book, “Tire Liti- lock” to the litigation caption or to This process of identifying a hazard and gation: A Primer,” which is available free limit the scope of the MDL only to choosing the best method for eliminating recalled devices. that hazard is known as a safety hierarchy.

JereBeasleyReport.com 11 It is well known within the engineering weight in machine design than user safety. Wendy Dolin is represented by R. Brent field that desgining a machine to elimi- Failure to adequately guard against Wisner, Michael L. Baum, Bijan Esfandiari nate a hazard and then guarding against hazards can cause any number of injuries and Frances M. Phares of Baum Hedlund the hazard are far superior methods for including amputations, lacerations, and Aristei & Goldman PC and David Rapoport safeguarding operators than warning even death. Every on the job injury and Matthew Sims of Rapoport Law them. However, all too often, we see involving a machine must be examined on Offices PC. The case is Dolin v. Smith- design engineers skip immediately to the a case by case basis. Just because guards Kline Beecham Corp. et al. (case number third rung of the hierarchy and merely are incorporated into a particular machine 1:12-cv-06403) in the U.S. District Court warn of hazards. does not necessarily mean that the user or for the Northern District of Illinois. Industrial machines, often due to the operator was adequately protected. Source: Law360.com very nature of the machines, create If you need more information on this hazards that cannot be completely elimi- subject, contact Evan Allen, a lawyer in nated. Machines that cut aluminum bend our Personal Injury & Products Liability steel, or bind materials can often times Section, at 800-898-2034 or by email at VIII. also cut, bend, or bind the user. To com- [email protected]. MASS TORTS pletely do away with these functions would eliminate the hazard, but also the UPDATE utility of the machine. In such cases, $3 Million Verdict Against GSK In guards are often the best means to retain Suicide Case both the function of the machine and Talcum Powder Litigation Update protect against the hazard. An Illinois federal jury has found Glaxo- The OSHA Act of 1970 requires that SmithKline liable for the death of Stewart Beasley Allen lawyers returned to St. every employer provide a workplace “free Dolin, a lawyer with Reed Smith LLP. The Louis in early April to start our fifth from recognized hazards,” and requires pharmaceutical giant was ordered to pay talcum powder trial. Our Plaintiff in this the guarding of any machine part, func- $3 million to the lawyer’s widow. The jury case is Lois Slemp, a 62-year old Wise, Vir- tion, or process that may cause injury to reached the conclusion that a generic ginia, resident who was diagnosed with operators or others. Hazards generally version of GSK’s Paxil caused Dolin to ovarian cancer in August 2012. She had occur in three locations: the point of oper- take his own life. The jury agreed with used Johnson & Johnson talcum powder ation, or the location where the machine Wendy Dolin that her husband had com- products for more than 40 years. cuts, bends, or presses a material, a power mitted suicide in 2010 under the influence The court empaneled 12 jurors on April take off or power transmission device, and of generic paroxetine, an antidepressant 10, with six additional jurors selected to any other moving parts. sold as brand-named Paxil. The jury serve as alternates. Ms. Slemp’s attorneys There are many different types of awarded Wendy Dolin $3 million, $2 spent thirteen days presenting evidence to guards that are commonly used to protect million for the wrongful death of Stewart the jury. After opening statements by all the user from the hazards associated with Dolin and $1 million for the pain he suf- three parties, the Plaintiff called her first these locations. Fixed barrier guards, fered in the days leading up to his death witness, a cosmetic regulations expert, interlocking devices, light curtains, and because of a dangerous side effect that his who testified regarding his review of sensors are all common methods to wife said caused him to take his own life. internal corporate documents and regula- protect the user from hazards. An appro- The verdict was said to be a vindication tory requirements. Other Plaintiff’s priate guarding method largely depends of Dolin’s belief, expressed in her 2012 experts who testified included a patholo- on the type of hazard. The most effective lawsuit, that her husband would still be gist and two epidemiologists, all of whom guards are those that do not hinder the alive if it weren’t for the paroxetine pre- addressed causation issues. Defense attor- function or utility of the machine while scription he began taking days before he ney’s began presenting their evidence on st safely eliminating the hazard posed to took his life by jumping in front of an L May 1 . This trial, like the last trial, is also the user. train in downtown Chicago. Mrs. Dolin a “defense pick,” and the trial is expected Even if the manufacturer takes appro- said her husband was restless and agitated to last a total of four to five weeks. priate steps to design and implement in the days leading up to his suicide, symp- Our firm has another talc trial in St. guards on machinery, the guards must toms of a listed Paxil side effect known as Louis scheduled for June. Additional talc remain in place and in good working akathisia. The side effect of the drug trials are currently set to take place in St. order to be effective. In Alabama, if an sometimes causes people to act out vio- Louis this fall, as well as additional trials employer removes a safety device incorpo- lently and impulsively. scheduled in Washington, D.C., and Cali- rated by the designers of the machine, the The lawsuit claimed that GSK knew fornia this summer. The lawyers from our injured may sue their employer outside of about the increased risk of suicide for firm who are involved in these cases workers’ compensation. Under Ala. Code adults taking paroxetine, particularly in include Ted Meadows, Danielle Mason, § 25-5-11(c)(2), an injured employee may the early days of treatment. Dolin said that David Dearing, Roger Smith, Brittany bring an action in tort if a safety device is the company had hidden data proving the Scott, Lauren Razick, and Ryan Beattie. intentionally removed from a machine. link from the U.S. Food and Drug Adminis- These cases are very common and are tration for decades. Mylan NV was the easily overlooked unless a detailed investi- manufacturer of the generic, but was dis- Janssen And Bayer Lose Preemption Bids As gation is conducted. missed from the case in 2014 after U.S. Xarelto Trial Starts All too often machines are unguarded, District Judge James Zagel ruled that GSK, inadequately guarded, or the wrong type as the maker of the brand-name drug Trial is now underway in a New Orleans of guard is used. In many instances pro- Paxil, was responsible for ensuring the Federal Court in the first Xarelto bell- ductivity and ease of use is given more label was accurate. wether trial. Days before trial was to begin

12 BeasleyAllen.com in the multidistrict litigation (MDL) over both the public and the FDA and that cates that more than $6 billion (USD) in the dangers of the blood thinner, a Louisi- there are issues surrounding certain clini- sales have been generated since 2011. ana federal judge refused to drop some cal trial results. Janssen and Bayer claim If you need more information on the claims against Bayer AG and Janssen Phar- that it believes Xarelto is safe. Abilify litigation, contact Melissa Prickett maceuticals Inc., saying they can’t neces- The Plaintiffs’ Steering Committee is or Matt Munson, both lawyers in our sarily blame U.S. Food and Drug represented by Leonard Davis of Herman firm’s Mass Torts Section, at 800-898-2034 Administration (FDA) red tape for their Herman & Katz LLC, Gerald Meunier of or by email at Melissa.Prickett@beasleyal- lack of label updates or for any noncompli- Gainsburgh Benjamin David Meunier & len.com or Matt.Munson@beasley- ance with Louisiana law. U.S. District Warshauer LLC and Andy Birchfield from allen.com. Judge Eldon Fallon denied two motions for Beasley Allen. The case is in the U.S. Dis- partial summary judgment that cited trict Court for the Eastern District of federal preemption as a defense to claims Louisiana. 3M Bair Hugger Forced Air Warming over alleged Xarelto misdosing and a label Source: Law360.com Blanket Litigation Update with inadequate warnings. Judge Fallon ruled that the companies Last month, we wrote about the Bair had failed to make a convincing showing MDL Formed Over Bristol-Myers Squibb’s Hugger warming blanket litigation and that FDA regulations prevented them from Blockbuster Drug Abilify deep joint infections that resulted when updating labels or creating more tailored the devices were used postoperatively fol- dose-analysis guidelines. He said, quoting The Judicial Panel on Multidistrict Liti- lowing total joint arthroplasties. Since that a 2016 ruling in the same district in gation (JPML) recently issued a Transfer time, the multidistrict litigation (MDL) Guidry v. Janssen Pharmaceuticals, that Order centralizing all Abilify lawsuits filed Plaintiffs’ Steering Committee and the state law requires drugmakers to consider in the federal courts across the country in Defendants have each selected 16 cases alternative designs and reasonably weigh a multidistrict litigation (MDL) in the out of a pool of 150 cases that were their products’ risks and utility before Northern District of Florida for the pur- chosen randomly by Judge Joan N. Erick- they are released, and that federal law poses of coordinated discovery and other sen for purposes of bellwether trial complements rather than contradicts the pretrial proceedings. United States District selection. state requirements. Judge Fallon wrote in Court Judge Casey Rodgers, who has Limited discovery will now begin on his order: served as Chief Judge for Florida’s North- these 32 cases, which will include the parties obtaining medical records for the This is exactly the Plaintiffs’ conten- ern District since 2011, and was also the patients, as well as records from third tion in the instant case. Accordingly, first female Article III Judge in history for parties such as the surgery centers where Guidry is directly on point and the that District, is presiding over the MDL. the procedures were performed. Once court finds Plaintiffs’ pre-market These cases allege that Abilify causes that process concludes, the parties will design defect claims under the LPLA patients to engage in compulsive behav- further narrow down the pool to a total of are not preempted. iors such as gambling, sexual activity, shopping and binge eating. In May 2016, eight cases to be set for full discovery and Judge Fallon’s conclusions were similar the U.S. Food and Drug Administration those cases will eventually proceed to for the other partial summary judgment (FDA) issued a Drug Safety Announcement trial. The goal of this process is to select motion: drug companies have room to regarding the uncontrollable behaviors, cases that are representative of all the comply with laws and to take action in the but it is alleged that the manufacturers filed cases, which will help encourage set- context of the FDA approval process or knew about it for many years, yet failed to tlement negotiations by establishing high after. His order said: warn users of these side effects because of and low values. The first bellwether trial is the impact it would have on sales. currently scheduled to begin on Manufacturers remain the master of MDLs benefit all parties involved by Feb. 5, 2018. their labels even after FDA approval, eliminating duplicative and costly discov- Beasley Allen lawyers Matt Munson and and there are clear pathways ery. Judges presiding over MDLs often set Megan Robinson continue to investigate through which a brand-name drug bellwether trials (or test cases) once dis- and file lawsuits related to 3M’s Bair manufacturer can make changes to covery is completed in an effort to encour- Hugger warming device. To discuss a their label without FDA approval. age settlement negotiations by setting potential Bair Hugger claim, contact Matt or Megan at 800-898-2034 or by email at Even when the FDA rejects certain data, high and low values, depending on how [email protected] or Megan. companies shouldn’t take it as proof that the juries find in those cases. This is [email protected]. the agency would reject a label change, accomplished by having both sides—the Judge Fallon said. He added: “‘Clear evi- Plaintiff’s Steering Committee, and the dence’ that the FDA would not approve counsel for the Defendant—select their the change ... requires more than a prior choices for what they believe to be a rep- “Low-T” Bellwether Trials Set To Begin refusal to add similar language.” resentative “pool” of cases after each filed This Summer In this first bellwether trial, Plaintiff case is carefully reviewed. A group of bellwether cases selected Joseph Boudreaux says that he started Abilify belongs to the atypical antipsy- from the nearly six thousand cases taking Xarelto to control his atrial fibrilla- chotic class of prescription drugs, and was pending in In re Testosterone Replace- tion in January 2014 and less than a month first developed in Japan by Otsuka Phar- ment Therapy Products Liability Litigation later was hospitalized for dangerous gas- maceutical Company. Bristol-Myers Squibb have completed discovery and are prepar- trointestinal bleeding requiring blood and Otsuka co-market Abilify in the ing for trial. The testosterone lawsuits transfusions. He says Janssen and Bayer United States, and while sales have been were consolidated for the purpose of misrepresented the safety of the drug to on the decline in recent years, data indi- general pretrial discovery.

JereBeasleyReport.com 13 In early 2015, the U.S. Food and Drug However, in an April 11, 2017 order, the design swaps the humeral head (ball) and Administration (FDA) cautioned consum- Court denied AbbVie’s request for either a glenoid (cup) to the opposite sides of the ers that prescription testosterone prod- Lone Pine order or a modification of the glenohumeral joint. The unique design ucts are only approved for men who have initial discovery process. A Lone Pine was intended to achieve greater range of low testosterone levels due to certain order requires a Plaintiff to preemptively motion in patients receiving total shoulder medical conditions. The FDA made clear serve a certification from a treating physi- replacement surgeries. that the benefit and safety of these drugs, cian or medical expert attesting to and The Biomet Comprehensive Shoulder including Androgel, Testim, Axiron, Fort- supporting an opinion that the Plaintiff System is the most recent example of ill- esta, and Androderm, have not been estab- has suffered an injury caused by the fated products haphazardly entering the lished for the treatment of low Defendant’s product and to do so before market. The joint system was quickly testosterone levels due to aging, or the case-specific discovery process is cleared through the controversial 510(k) “Low T.” completed. process. Therefore, the system was never The FDA required all testosterone In denying AbbVie’s motion without safety-tested in humans. This alternative replacement manufacturers to change prejudice, the Court held that “imposing approval process is allowed for devices their labeling to clarify the approved uses an expert-certification requirement on the that are similar to others that are already of these medications. The FDA also MDL as a whole is premature at this approved. Righting Injustice has required new warnings about a possible point.” The Court did determine that it denounced the process, explaining that it increased risk of heart attacks and strokes may revisit this issue after ruling on “the bypasses clinical testing and more rigor- in patients taking testosterone. Finally, the pending summary judgment motions ous FDA medical review. FDA mandated manufacturers of approved (or, perhaps, after one or two bellwether If you or somebody you know had a testosterone products to conduct a well- trials, which are set for June and Biomet Comprehensive Shoulder System designed clinical trial to more clearly July 2017).” used in a total shoulder arthroplasty and address the question of whether an If you need more information on this lit- complications were experienced, you can increased risk of heart attack or stroke igation, contact Jenna Fulk, a lawyer in contact Matt Munson, a lawyer in our exists among users of these drugs. our firm’s Mass Torts Section, at 800-898- Mass Torts Section, at 800-898-2034 or by Additionally, a recent study rebutted 2034 or by email at Jenna.Fulk@beasley- email at [email protected]. health benefit claims for off-label testoster- allen.com. Matt will answer any questions you one use. The study systematically Source: Law 360; Treatment of Men for “Low might have. reviewed 156 randomized, relevant con- Testosterone”: A Systematic Review, Samantha Huo, Source: Righting Injustice trolled trials published from January 1950 PLOS One, 9/21/16 to April 2016 comparing testosterone therapy benefits to a placebo in men with Third Circuit Revives Fosamax Fracture low testosterone. The study found that tes- Zimmer Biomet Shoulder Replacement Cases tosterone therapy “did not show consis- System Recalled Due To Excessive tent benefit for cardiovascular risk, sexual Fracturing On March 22, 2017, the Third Circuit function, mood and behavior, or cogni- Court of Appeals breathed new life into tion.” Ultimately, the study showed that The U.S. Food and Drug Administration the Fosamax Multidistrict Litigation testosterone supplementation provided no (FDA) in 2008 approved Zimmer Biomet’s (MDL). Hundreds of MDL Plaintiffs allege consistent clinical benefits and that a Comprehensive Reverse Shoulder implant. that they suffered serious femur fractures placebo was equally as effective. However, after only eight years on the while taking Fosamax, and that Merck The first “Low-T” bellwether trial market, the manufacturer recalled its failed to warn patients about that risk. against AbbVie, Inc., manufacturer of the implantable joint systems last December. The Fosamax cases were initially con- testosterone replacement product Andro- The company issued the Class 1 Recall solidated into an MDL in the District of gel, is set for jury selection on June 5, only after thousands of patients suffered New Jersey. In 2014, after discovery and a 2017, in Chicago in the United States Dis- from fractures in the humeral tray compo- bellwether trial, U.S. District Judge Joel A. trict Court for the Northern District of Illi- nent. A Class 1 recall is the most serious Pisano granted Merck’s motion for nois. Plaintiffs contended that the type of recall, used for defective devices summary judgment and dismissed all of Defendants failed to adequately warn con- that can cause serious injury or death. the MDL Plaintiffs’ claims, finding they sumers about the risks of stroke, deep While the recall is limited, approxi- were preempted by federal law. Under the vein thrombosis, pulmonary embolism mately 3,662 unsuspecting patients could Supreme Court’s decision in Wyeth v. and cardiovascular injury associated with be affected. Zimmer Biomet warns that Levine, drug companies can’t be sued for testosterone therapy, while improperly patients with a fractured humeral tray may failure to warn where there is “clear evi- marketing their drugs as a remedy for age- require a revision surgery—a surgery US dence” that the FDA considered a pro- related conditions rebranded as “Low T.” Recall News described as dangerous. posed warning but rejected it for In April 2017, the court received a final Patients could also experience permanent inadequate data. round of briefs addressing several key loss of shoulder function, infection and The Third Circuit reversed Judge Pisa- issues in the bellwether cases, including even death. According to Righting Injus- no’s ruling because there was a valid argu- motions for summary judgment, Daubert tice, the shoulder system is used in ment that Merck could have gotten challenges against Plaintiff and Defense patients with extreme shoulder injuries, approval for a fracture warning if it had experts as well as certain medical and cau- including rotator cuff tears and for described the fractures differently. The sation issues. At press time, the Court had patients who have a severe type of shoul- FDA’s communication to Merck showed not ruled on these issues, but is expected der arthritis known as arthropathy and that the agency specifically objected to to do so very soon. who have previously undergone failed Merck’s use of the term “stress fracture,” shoulder joint replacement. Its unique

14 BeasleyAllen.com since not all fractures related to Fosamax In the 2002 Supreme Court case claims about the drug’s labeling are suffi- fit that description. Accordingly, the panel Thompson v. Western States Medical ciently specific to pass muster. However, found that a reasonable juror could con- Center, the Court extended First Amend- he found the suit’s marketing-campaign clude that, had Merck submitted a revised ment commercial-speech protection to allegations too broad. Consumers say GSK warning, it could have been approved. compounding pharmacies for the first knowingly misrepresented the safety of This is a very good result on the pre- time, allowing them to promote their com- taking Zofran during pregnancy in its emption issue. Lawyers in our firm have pounded drug products. In 2012, the advertising and marketing campaigns. handled a good number of Fosamax cases. Second Circuit Court of Appeals further However, the plaintiffs haven’t provided a Sources: Law360.com and http://ca3blog.com/ expanded First Amendment commercial specific allegation — either in the master uncategorized/third-circuit-en-banc-procedure-the- speech protection in pharmaceutical mar- complaints or the individual ones — about basics-and-beyond/ keting in United States v. Caronia. The any advertisements, brochures, presenta- Court found that the First Amendment tions or the like. Judge Saylor said allega- protected the right of a pharmaceutical tions that individual GSK sales FDA Delays Final Rule On Off-Label sales representative to promote off-label representatives misrepresented the safety Promotion use to doctors in a way that was not of taking Zofran during pregnancy to untruthful or misleading. doctors were also expressed in very The Food and Drug Administration Currently, the “intended use” definition broad terms. (FDA) has delayed a rule that would regu- states that if a manufacturer has mere Judge Saylor found allegations that late off-label drug and device promotion. knowledge that a drug or device is used Zofran’s labeling misrepresented its safety The rule was scheduled to take effect for off-label conditions, purposes or uses, during pregnancy to be sufficiently spe- March 21, 2017, but has been delayed until the manufacturer is required to provide cific, pointing to a statement about terato- March 19, 2018, so the FDA could consider adequate labeling for that use. (See 21 CFR genic effects, which the suit alleges is public comments. The rule is viewed as §201.128 and 21 CFR §801.4). The pro- misleading, that has been included in the giving the FDA broad authority to police posed rule issued on Sept. 25, 2015, would drug’s prescribing information since 1993. off-label promotion, and the delay comes have deleted this standard. However, the The judge said: in response to a petition to stay and for final rule, as published in January, reconsideration filed by Pharmaceutical retained and amended the current lan- Accordingly, because plaintiffs ade- Research and Manufacturers of America, guage to include a “totality of the evi- quately pleaded the content, time, the Biotechnology Innovation Organiza- dence” standard that was not in the and place of the allegedly false rep- tion and a drugmaker coalition called the proposed rule. resentations made in Zofran’s Medical Information Working Group. The new standard would allow the FDA product labeling, the fraud-based The FDA contends that misleading infor- to consider all evidence, including inter- claims premised on that misrepre- mation could do more harm than good, nal deliberations, clinical practice guide- sentation satisfy the requirements of and that looser restrictions would make lines and non-promotional scientific Rule 9(b). Whether those represen- manufacturers less inclined to do perform exchange as evidence of intended use to tations were actually false is, of due diligence by conducting scientifically determine whether a company engaged in course, a question for another day. sound clinical studies. Industry argues off-label promotional activity. The FDA The MDL plaintiffs accuses GSK of mar- that the rule will impede dissemination of would continue to determine the prod- keting and promoting Zofran to treat preg- information, thus violating their First uct’s intended use by its labeling, promo- nancy-related nausea and vomiting, when Amendment rights, and will “chill innova- tional claims, advertising, oral or written the U.S. Food and Drug Administration tion.” They also contend that the FDA vio- statements by a manufacturer or its repre- cleared it only for nausea and vomiting lated the Administrative Procedure Act sentatives, circumstances surrounding the related to chemotherapy, radiation therapy (APA) by not providing adequate notice distribution or sale of a product, and other or operations. The plaintiffs say that the and an opportunity to comment on the relevant evidence. labels for Zofran and its generic equiva- revised “intended use” definition as In its notice to delay, the FDA stated that lent, ondansetron, don’t specify that the published. “good cause” existed for the delay because drug has been linked to cardiovascular Doctors can prescribe drugs off-label, or it would allow the public to comment on and cleft palate birth defects. for uses outside those indicated on their the language that was introduced in the The plaintiffs are represented by Tobias label as approved by the FDA. However, final rule that did not first appear in a pro- L. Millrood of Pogust Braslow & Millrood under the False Claims Act and the FDA, posed rule, thereby skirting the Adminis- LLC, Kimberly D. Barone Baden of Motley drug manufacturers cannot advertise or trative Procedure Act. Public comments Rice LLC, M. Elizabeth Graham of Grant & promote their products off-label. Oppo- on the rule must be submitted to the FDA Eisenhofer PA, and Robert K. Jenner of nents of off-label promotion argue that the prior to May 19, 2017. Janet Jenner & Suggs LLC and and Kim- off-label use has not passed scrutiny by berly Dougherty of Andrus Wagstaff. The the FDA, the chief regulatory body case is In Re: Zofran (Ondansetron) Prod- charged with ensuring the safety and effi- Judge Keeps Fraud Claims Against GSK ucts Liability Litigation (case number 1:15- cacy of a drug for specific indications, and Alive In Zofran MDL md-02657) in the U.S. District Court for exposes patients to inappropriate risk. In the District of Massachusetts. recent years, however, there has been a A Massachusetts federal judge has Source: Law360.com trend toward heightened protection of refused to dismiss fraud-based claims from commercial speech in the health care multidistrict litigation complaints alleging arena, and opportunities have opened up that GlaxoSmithKline PLC’s anti-nausea for off-label promotion. drug Zofran is linked to birth defects. U.S. District Judge F. Dennis Saylor IV said that

JereBeasleyReport.com 15 IX. only products on the market that effec- The injunctive relief afforded by the tively reduce side effects allegedly because settlement provides terminal divi- BUSINESS they are the only products that actively dends having a face amount of $110 LITIGATION heat and humidify insufflation gas.” million, a truly exceptional result. Lexion filed counterclaims, saying Sur- There is no subjective or dispropor- giQuest bent the truth when it called its tionate treatment of the settlement tubes “airtight,” named them “AirSeal,” class members, because all of them Jury Awards $12.2 Million To Surgery Tube saying their safety level had never been will receive settlement class benefits Co. In False Ad Lawsuit achieved before. It was stated further that calibrated to the objectively deter- SurgiQuest told customers the tubes obvi- mined cash surrender values of A Delaware federal jury has awarded ated the need to heat and humidify gas their respective settlement policies. $12.2 million to surgery-device maker before injection into abdomens. Lexion Lexion Medical LLC, including $10 million contended that SurgiQuest had violated The settlement has received contin- in punitive damages, agreeing with Lexion the Lanham Act, Delaware trade-practices gency approval by the Pennsylvania Insur- that rival SurgiQuest Inc. committed false law, and, by way of misleading statements, ance Commissioner, following advertising in its fight over tubes used in unfair-competition law. Lexion said: proceedings before the Pennsylvania laparoscopic procedures. SurgiQuest had Department of Insurance involving the sued Lexion in Delaware federal court in These statements actually deceived regulatory issues at the center of the case. March 2014 in connection with a Surgi- or have the tendency to deceive a A federal judge stayed litigation in April Quest laparoscopy system called AirSeal. substantial segment of purchasers 2014 pending those administrative Lexion’s rival devices are called Insuflow or prospective purchasers of proceedings. and Synergy. All three devices facilitate medical devices. The lawsuit was filed in November the injection of gas into a patient’s body 2012. Plaintiffs Daniel and Edith Harsh- between the abdominal wall and the SurgiQuest’s suit was initially a barger argued that while Penn Mutual was organs that are being worked on, which response to a Minnesota federal court suit obligated under state law to return all gives the surgeon more maneu- by Lexion that was dismissed for jurisdic- profits over a “safety fund” limit, capped vering room. tion reasons. SurgiQuest believed that at 10 percent of its reserves, to participat- According to SurgiQuest, Insuflow and Lexion would try to refile the suit else- ing policyholders, it repeatedly failed Synergy use a traditional design with where and filed its own lawsuit. to do so. one-way valves that can leak, trap instru- Lexion is represented by David Moore The policyholders claimed Penn Mutu- ments, and cause camera blurriness, and Richard Horwitz of Potter Anderson & al’s breach of its obligations cheated poli- where AirSeal “establishes a horizontal air Corroon LLP and David Wille of Baker cyholders out of more than $5 million barrier” that serves the same function but Botts LLP. SurgiQuest is represented by over at least 18 years. The complaint said doesn’t give rise to the same problems. In Denise Kraft of DLA Piper. The case is that Pennsylvania state law requires the the claims and counterclaims the two SurgiQuest v. Lexion (case number 1:14- state’s life insurance companies to return companies filed over the years, each cv-00382) in the U.S. District Court for the all surpluses that accumulate past a accused the other of misleading clients District of Delaware. maximum annual “safety fund” limit to and prospects with regard to the other’s Source: Law360.com policyholders. product. But the jury found for Lexion, Unless the state Insurance Commis- awarding $2.2 million in damages for lost sioner grants an exemption, that limit is profits and $10 million in punitives. The capped at 10 percent of its financial jury failed to award anything to Lexion for X. reserves, the complaint stated, adding that “corrective advertising damages.” U.S. Dis- INSURANCE AND Penn Mutual had never sought nor trict Judge Gregory Sleet presided over received such an exemption. During the the trial. FINANCE UPDATE administrative proceedings, Penn Mutual The jury found that SurgiQuest’s state- argued that the plaintiffs’ relied-upon pro- ments were false regarding “heat and vision has been implicitly repealed humidification,” regarding “air,” and Penn Mutual Settles Insurance Surplus through legislation and non-enforcement regarding “smoke.” The latter comes into Fund Suit For $110 Million by the Department of Insurance and that play during certain laparoscopies that the company’s retained surplus, nonethe- utilize burning and thus create smoke that Pennsylvania Mutual Life Insurance Co. less, complied with state law. may need to be cleared out of the has agreed to pay $110 million in settle- The plaintiffs are represented by Joseph abdomen. The one area in which the jury ment with a class of policyholders who N. Kravec Jr. of Feinstein Doyle Payne & disagreed with Lexion was on its claim alleged the company breached its obliga- Kravec LLC, Jason B. Adkins and John that SurgiQuest had committed a decep- tions by improperly withholding surplus Zavez of Adkins Kelston & Zavez PC, tive trade practice. funds rather than distributing them as div- Andrew Friedman of Bonnett Fairbourn On all of SurgiQuest’s claims against idends. The settlement involves about Freidman & Balint PC, and Mark A. Chavez Lexion—false advertising, deceptive trade 293,000 whole life insurance policies of Chavez & Gertler LLP. The case is practices, and unfair competition—the issued by Penn Mutual that were in force Harshbarger et al. v. Pennsylvania jury found for Lexion. Initially, the core of between Jan. 1, 2006, and Dec. 31, 2015. It Mutual Life Insurance Co. (case number SurgiQuest’s claims was on Lexion’s provides for an automatic payout of divi- 2:12-cv-06172) in the U.S. District Court stance over the need to warm and humid- dends to the settlement class, according to for the Eastern District of Pennsylvania. ify gas that goes into the abdomen. Lexion a motion for preliminary approval of the had told customers its “devices are the settlement. The motion says:

16 BeasleyAllen.com Bad Faith Suit Will Go Forward In members will receive an average of XII. Massachusetts Court $4,700 each. The single certified class in the matter PREMISES A Massachusetts federal judge has ruled is defined as all persons employed by ABM LIABILITY UPDATE that an “unfair insurance practices suit” in any security guard position from July will go forward. It was alleged that Sedg- 12, 2001, to July 1, 2011, who worked a wick Claims Management Systems Inc. shift exceeding four hours without being failed to make a reasonable settlement allowed to take an uninterrupted rest PG&E To Pay $86.5 Million In Settlement offer before or after an underlying $16 period. The class of current and former Over San Bruno Explosion-Linked Talks million verdict was returned in a nursing security guards won the nearly $90 Pacific Gas and Electric (PG&E) Co. has home death case. U.S. District Judge Patti million award on summary judgment in agreed to pay $86.5 million to settle B. Saris denied a summary judgment July 2012. claims over its closed-door communica- motion in a suit brought by the family of ABM appealed, arguing in its brief that tions with state regulators following the Genevieve Calandro, who died in 2008 at the lower court judge’s “unprecedented” 2010 San Bruno gas line explosion. The a nursing home. ruling “defies law and reason” and would penalty resolves an investigation brought In the underlying suit, the Calandro cripple California companies without pro- by the California Public Utilities Commis- family said the nursing home was viding any real benefit to employees. If sion (CPUC) that the San Francisco-based negligent and caused the resident’s death. upheld, ABM argued, the ruling would utility engaged in “improper communica- Sedgwick, the claims adjuster and admin- require companies to force employees to tions” and “back-channel deals” with state istrator for a Hartford Insurance Group take their rest breaks off their work sites, regulators in connection with its role in subsidiary that insured the nursing home without their personal cellphones. The the deadly 2010 explosion. Eight people company, failed to make a prompt, fair appeals court in December 2014 vacated were killed and 58 were injured in the and equitable settlement offer under the award, saying that being on call does explosion. Thirty-eight homes were also Massachusetts’ consumer-focused not constitute performing work in viola- burned to the ground. insurance laws. tion of the rest break law. But a majority of A major share of the settlement relates The Calandros are represented by David the California Supreme Court disagreed, to the foregoing of revenue collection for J. Hoey, Krzysztof G. Sobczak and Allan saying in its December decision that the years 2018 and 2019, which translates to Galbraith. The case is Garrick Calandro as state’s labor code and Wage Order 4 an approximate 22-cent reduction in resi- administrator of the estate of Genevieve require “employers relinquish any control dential customers’ monthly bills. This Calandro v. Sedgwick Claims Management over how employees spend their break amount totals $63.5 million of the settle- Services (case number 1:15-cv-10533-PBS) time, and relieve their employees of all ment. PG&E will also pay $6 million each in the U.S. District Court for the District of duties—including the obligation that an to the cities of San Bruno and San Carlos, Massachusetts. employee remain on call.” pay $1 million to the California General Source: Law360.com Even though state law and regulations Fund, and make a request for a one-time don’t mention on-call time, “one cannot $10 million adjustment in revenue require- square the practice of compelling employ- ments for 2020 through 2022. ees to remain at the ready, tethered by The proposed settlement comes less XI. time and policy to particular locations or than a year after a California federal jury communications devices, with the EMPLOYMENT AND convicted the utility of five criminal requirement to relieve employees of all counts for violating pipeline safety stan- FLSA LITIGATION work duties and employer control during dards and obstructing a subsequent 10-minute rest periods,” the majority of federal investigation into the September the court said. After remand, the parties 2010 gas line explosion in San Bruno, a Security Guards’ $110 Million “On-Call” reached the settlement. Judge Wiley in suburb of San Francisco. The federal gov- Break Settlement Gets Approval February told them they were “close” to ernment had charged PG&E with violating getting it approved, pending several small minimum federal safety standards out- A California judge has granted prelimi- concerns regarding the proposed class lined in the Natural Gas Pipeline Act and nary approval to ABM Security Services’ notice and simplifying objection obstructing agency proceedings after it $110 million settlement to resolve long- procedures. failed to provide all of its records to the pending claims that 15,000 guards were The Plaintiffs are represented by National Transportation Safety Board unlawfully required to carry radios and Michael Breen Adreani, Drew E. Pomer- during its investigation. stay “on call” during rest breaks. Los ance and Marina N. Vitek of Roxborough In January, a California federal judge Angeles Superior Court Judge John Pomerance Nye & Adreani LLP; Jeffrey ordered PG&E to pay the maximum $3 Shepard Wiley expressed reservations Isaac Ehrlich of The Ehrlich Law Firm; million statutory fine and complete 10,000 about the amount of attorneys fees Monica Balderrama and G. Arthur Meneses hours of community service, with 2,000 of requested by class counsel, but prelimi- of the Initiative Legal Group LLP; Scott those hours to be carried out by high-level narily approved ABM’s agreement to pay Edward Cole and Matthew R. Bainer of personnel. Under the $86.5 million settle- $110 million to end the 12-year-long suit Cole & Associates; and Alvin L. Pittman. ment, which must be approved by Califor- alleging its policy requiring the guards to The case is Jennifer Augustus v. Ameri- nia’s five-member Public Utilities carry radios during breaks violated the can Commercial Security Services et al. Commission, PG&E admitted to commit- state’s Labor Code. The amount of settle- (case number BC336416) in the Superior ting “multiple violations” of the commis- ment represents the roughly $90 million Court of the State of California, County of sion’s ex parte rules. The agreement said: judgment the class won in 2012, plus Los Angeles. interest. Under the settlement, class Source: Law360.com

JereBeasleyReport.com 17 PG&E’s employees and agents XIII. to be able to act on it. According to data engaged in communications with collected by AFL-CIO, it would take Ala- decision makers at the commission, WORKPLACE bama’s 24 OSHA inspectors roughly 114 as well as related conduct that was HAZARDS years to visit every business in the state. harmful to the regulatory process. Ms. Seminario added: The proposed settlement involves the That makes it difficult to catch cities of San Bruno and San Carlos, the Alabama’s Workplaces Could Become More issues within the six month time CPUC Office of Ratepayer Advocates, the Dangerous After OSHA Repeal frame and enforcement nearly CPUC Safety and Enforcement Division impossible. and The Utility Reform Network. President Donald Trump has repealed Since coming into power, President Source: Law360.com an Obama-era health and safety regulation that will leave Alabama workers more at Trump and Republicans have reversed risk from health and safety violations. The more than 30 regulations using what’s little known Occupational Health and known as the Congressional Review Act, a A Lawsuit Filed By The Parent Of A Student Safety Administration (OSHA) regulation, powerful legislative tool that enables Con- Dragged To Death By Bus known as the “volks” rule, previously gress to quickly overrule newly estab- allowed OSHA to pursue companies for lished federal rules. The act also prevents A lawsuit has been filed arising out of safety breaches for up to five years after the reissuing of regulations, meaning an incident where a Texas State student an incident occurred. OSHA may never be able to reinstate the was dragged to death by a bus after a fra- The repeal means that OSHA is limited five-year statute of limitations in ternity party in Martindale, Texas. The to a statute of limitation of six months. the future. lawsuit was filed against the bus company, According to experts in OSHA regulation, The repeal is clearly a loss for workers. multiple fraternities, and a number of the rollback of the rule could see employ- In recent months, the dangers of shipyards others. The lawsuit filed by Freddie Joey ers hide injury data and recurring hazards have been on full display in Mobile. A Taylor Jr., the father of Jordin Taylor, seeks from regulators. This would make it detailed investigation into work practices $10 million in damages. It’s alleged that harder to identify problems at specific at Austal uncovered dozens of injuries Skyline Party Bus Company; its manage- business and across wider industries. being sustained by employees using a ment officer Brandon Burleson; B&B Shut- This is particularly troubling at ship- cutting tool known as the “widowmaker.” tles; Gabriela Wilson, the driver of the bus yards where the injury-accident rate is Workers that have been injured by the tool on the night of the incident; SMTX Proper- around 80 percent that of construction are currently involved in a court case ties; VCD San Marcos River; and four and general industry, according to recent against Austal in which they claim the U.S. national fraternities at Texas State Univer- Labour statistic records. Between 2005 Navy contractor forced them to swap out sity all played roles in the death of and 2015, for example, there were 76 the original blade in the tool for another the student. deaths at private shipyards around the blade with larger cutting teeth in order to On Oct. 28, 2016, the student was found country. Peg Seminario, Safety and Health hasten the manufacturing process. The wedged between the ground and the axle director at AFL-CIO, said: blade swap went against the manufactur- of a party bus at Cool River Ranch, where er’s instructions, which explicitly warned fraternities Delta Tau Delta Zeta Delta, This means that in the worst cases against changing of the blade. Some Kappa Alpha Order Epsilon Iota, Alpha OSHA won’t be able to take enforce- workers lost fingers while others suffered Tau Omega and Pi Kappa Alpha hosted ment action, and the employers are severe lacerations to their face, neck and events. The lawsuit claims Miss Taylor was going to be able to keep doing what upper body. struck by a party bus before her body they are doing because there are no Many of the injuries go back years, became trapped underneath. She was consequences. It essentially takes meaning that under the now-current rules found dead the following day by a away OSHA’s ability to enforce pat- OSHA would not be able to act against mechanic. terns of record keeping violations, Austal, although it could make suggestions The lawsuit claims all of the defendants and what that means is that worse on better practices. For years there has created a dangerous environment by not employers that have a pattern of been confusion over the statute of limita- having enough security for an event cater- hiding injuries or falsifying records tions around OSHA’s enforcement of ing to more than 2,000 people; by having will escape punishment. safety breaches. During the last days of poor lighting; by allowing underage drink- the Obama administration, the regulation While the repeal means OSHA is unable ing; and by allowing reckless driving and was clarified to mean that the agency to legally pursue accidents and incidents negligence by the bus drivers, who were could take action up to five years after a that occur at a company more than six entering and exiting the property. breach of health and safety occurred. months later, the agency is still able to Source: KVUE.com That rewriting of the regulation by the view all data going back five years. That Trump Administration has upset a number regulation has not changed. This means of lawmakers who say that it’s the job of that OSHA can still identify industry-wide the legislative branch to write laws. Rep. hazardous trends and make suggestions to Bradley Byrne, who represents Mobile individual companies on how to fix them. County in Congress, said after the repeal However, the agency can’t act against that “the role of the executive branch is to companies that have flouted rules more enforce the laws—not rewrite them” and than six months ago. OSHA inspectors that “this OSHA power grab was com- would need to identify an issue at a pletely unlawful.” “It would have done company within the six-month timeframe

18 BeasleyAllen.com nothing to improve workplace safety next decade[.]” That growth is pensation a client can receive without while creating significant regulatory con- unlikely to slow, but comes at a high a third-party claim. The additional fusion for small businesses,” added Byrne. price for employees. In 2010, workers claim could be a product liability suit “Our efforts are to uphold the rule of law in Alabama auto parts plants had “a against a machine’s manufacturers, and advance responsible, proactive poli- 50 percent higher rate of illness and distributors, suppliers, retailers or cies that keep America’s workers safe.” injury than the U.S. auto parts indus- any others who made the product Source: Christopher Harress of AL.com try as a whole,” the Bloomberg piece available to the public. notes. The industry’s growth and high injury rate emphasize the impor- Designers and manufacturers have a tance of understanding the complexi- responsibility to use accepted indus- Third-Party Liability In Workplace Injuries ties of on-the-job injury cases and the try practices to make their products compensation clients can receive. safe. For example, microwaves are Kendall Dunson, a lawyer in our firm’s designed with doors because the Personal Injury & Products Liability One of the workers highlighted in the designer and manufacturer knew Section, wrote an article for Law360 last Bloomberg piece, Regina Allen Elsea, they must find a way to protect con- month on workplace injuries. Kendall 20, of Five Points, Alabama, entered a sumers from the radiation released by handles this type litigation for our firm. I robotic machine in June 2016 at auto the appliance. Microwaves do not am setting out his article below. parts manufacturer Ajin USA’s plant, start if the door is open for that The headlines about on-the-job inju- where she was a temporary reason. Just as microwaves were ries usually focus on employers’ fail- employee, to try to fix a malfunction. designed and manufactured to reduce ings, and rightfully so. A quick Several other employees had tried health risks, the same should be true internet news search shows employ- and—fortunately for them—failed to of machines used in the manufactur- ers coming under fire for a trench col- fix the machine after a maintenance ing process. What safety mechanisms lapse that killed two people last year crew never showed up to make could have saved Regina Elsea? She and for a boiler explosion that killed repairs and production came to a would still be alive if the machine did three workers at a box factory earlier standstill. To her ultimate detriment, not originally malfunction or if it this month. Employer failings are Elsea apparently knew what she was included a mechanism to prevent it undoubtedly a factor when employ- doing because the machine began from operating when a person is near. ees lose a finger, a limb or their lives. functioning while she was still inside, An expert witness, such as an engi- However, it is important to note how crushing her. She died days later from neer who has designed a similar product liability impacts workers’ her injuries. The Occupational Safety machine or designed safety mecha- compensation cases and on-the- and Health Administration (OSHA) nisms for a similar machine, would be job safety. fined Ajin USA $2.5 million for serious able to explain what safety precau- and willful safety violations, meaning tions should have been included to Unfortunately, the examples of OSHA felt the employer knowingly properly protect workers from harm. workers being injured on the job are failed to comply or acted with plain numerous; again, all it takes is a indifference to employee safety. In my experience with on-the-job simple news search. In the past few The company is contesting injuries, safety devices often are seen months, auto parts manufacturers in OSHA’s findings. as a slowdown in the manufacturing Alabama have come under fire for process, and for the auto parts manu- unsafe working conditions after a In the above case, we expect to facturers, time is money. Under their Bloomberg Businessweek article include the machine’s manufacturer delivery system, a parts manufacturer highlighted serious injury rates as a Defendant along with Joon LLC, can be fined thousands of dollars among the industry’s workers. The d/b/a Ajin USA, the custodian of the each minute the order is late to an article features employees at auto equipment. Ajin USA’s failure to automaker’s production plant. The parts manufacturers around the state provide a safe working environment stress on the production timeline who have had fingers and arms in accordance with OSHA regulations means safety devices are often crushed in machines, have suffered and the machine manufacturer’s bypassed or removed, if they were third-degree burns after being failure to provide adequate guarding ever even in place. Due to the rush, engulfed in flames, or have suffered and safety mechanisms led to the employees are often needlessly chemical burns after falling into a vat unnecessary death of Regina Elsea. exposed to serious hazards that could of acid. All this comes as Alabama This is often the case. On-the-job easily be prevented by simply chang- tests its “New Detroit” nickname. injury cases are inextricably inter- ing the design of a robot. A year According to the Alabama Depart- twined with product liability. Investi- before Regina Elsea’s death, an OSHA ment of Commerce, more than 160 gating any machine or product representative visited executives at automotive parts suppliers operate in involved in an on-the-job injury is in Hyundai Motor Co. and Kia Motor Co. Alabama, employing 25,000 Alabami- the best interest of a client. What may to stress the importance of workplace ans. The auto-manufacturing sector as initially appear to be a workers’ com- safety in their automotive plants and a whole employs more than 50,000 pensation claim may actually turn out in their auto parts suppliers’ plants people. Alabama Commerce Secre- to be a case involving a dangerous because otherwise lives would be tary Greg Canfield told the Birming- product or piece of equipment. This lost. Clearly, that is abso- ham Business Journal in 2015, is especially useful because workers’ lutely the case. “Alabama’s auto manufacturing sector compensation benefits are usually capped, limiting the amount of com- However, for defective machines that is well-positioned for growth over the contribute to on-the job injuries, the

JereBeasleyReport.com 19 warnings are rarely given before objects, difficulty steering, and reduced National Transportation and Safety Board’s someone gets hurt. Therefore, filing a responses to emergency driving (NTSB) recommendations in its new, third-party claim not only helps your situations. stricter flight regulations and procedures client, but could save other workers’ in 2014, coming after a deadly decade. It lives—or at least give them an oppor- • .08—There will be decreased concen- was reported that from 2006 to 2015 a tunity to be safe while doing tration, short-term memory loss, diffi- crash occurred in the U.S. every 40 days. their jobs. culty controlling speed, reduced The NTSB’s recommendations were based, information processing (traffic signals in part, on information analyzed by the If you need more information on any and other visuals), and impaired Air Medical Physician Association. The aspect of workplace litigation, contact perception. group examined HEMS accidents that Kendall Dunson at 800-898-2034 or by • .10—There will be a reduced ability to occurred over a 20-year period and deter- email at Kendall.Dunson@beasleyallen. mined the leading causes for most acci- com. He will be glad to talk with you. maintain lane position and to brake appropriately. dents included the time of day, Source: Kendall Dunson wrote the above article for environmental factors (such as weather Law360 and it appeared on April 21, 2017. • .15—The driver will have significant dif- conditions, flight altitude and geographic ficulty controlling vehicle, paying atten- location) and time pressure due to the tion to driving, and processing the patient’s condition. Robert Sumwalt, an XIV. things he or she sees and hears. NTSB Board Member, believes the regula- tions implemented in 2014 were a good TRANSPORTATION Alcohol is not the only drug that causes first step. However, he has urged the impaired driving. It has been reported industry and regulators to incorporate that drugs other than alcohol are involved additional measures designed to confront in about 18 percent of motor vehicle Drinking And Driving Do Not Mix the leading causes of HEMS crashes. Some driver deaths. Because of the significant of the additional measures Sumwalt advo- Alcohol-related deaths on our nation’s and badly needed attention paid to alco- cated for include better technology and highways continue to be a huge problem. hol-related deaths, the problems caused by more training for pilots operating and In 2015, 10,265 people died in drunk the other drugs do not always get the relying on the improved technology. driving crashes—one every 51 minutes— attention they receive. Helionix offers two computers that and 290,000 were injured in drunk All states should take a proactive stand include up to four electronic displays driving crashes. It’s obvious drunk against drinking and driving. There are designed to improve pilots’ situational driving is still a major problem in this many things that can be done to help curb awareness. It also provides a four-axis country. It appears the numbers of DUI- the carnage that is occurring on our autopilot and a Traffic Advisory System to related deaths were even greater last year. nation’s highways. But regardless of laws assist pilots in detecting and avoiding At press time we weren’t able to get the on the books, it is both dumb and danger- other aircraft. Neither Airbus nor STAT final numbers from a reliable source. ous to drive a vehicle after drinking alco- MedEvac have discussed pilot training for Alcohol impaired driving can be a major holic beverages. the new technology and cockpit. safety hazard even though the driver Source: Department of Transportation and ALEA However, Vertical Magazine notes that involved may not be “legally intoxicated.” Airbus has a state-of-the-art simulator that In all states it’s a crime to drive with a is customizable to provide realistic scenar- blood alcohol concentration (BAC) of .08 Can Airbus’ Helionix Digital Avionics ios for all helicopter missions. The percent or above. However, the laws and Improve Safety In The Helicopter Emergency company believes that its latest products penalties for DUI vary greatly from Medical Services Industry? will significantly enhance helicopter state to state. safety and is putting them to the test in a It might be good to take a look at what it During the annual industry-sponsored segment of the industry fraught with takes for a driver to reach the level of .08 Heli-Expo held recently in Dallas, Airbus unique safety challenges such as time con- percent. These are the factors: how fast a Helicopters (Airbus) and STAT MedEvac straints and intense pressure to fly in less person drinks, their weight, their gender announced that the Pennsylvania-based than favorable environmental conditions. and how much food they have in their medical transport service will be the first If you need more information on this stomach. For an average male it takes in North America to operate the Helionix subject contact Mike Andrews, a lawyer in three drinks, and for an average female, digital avionics suite. This was reported by in our firm’s Personal Injury & Products only two drinks will usually be enough. Vertical Magazine. Airbus Helicopters Liability Section, at 800-898-2034 or by It should be noted, however, that even claims that the new suite along with a email at [email protected]. before reaching .08 percent, a person’s newly designed helicopter cockpit aboard Mike handles aviation litigation for driving ability can be impacted. The fol- the H135 will help improve the pilot’s situ- the firm. lowing will give an indication of how ational analysis and reduce pilot workload. Sources: Vertical Magazine, Airbus Helicopters Inc., alcohol at numerous levels will impair a The goal for the new technology and phys- Jere Beasley Report (December 2016), CNN person’s driving: ical changes is to maximize safety and reduce the risk of crashing. • .02—There will be a decline in visual In a previous issue of the Report, we Defects In Guardrails Are A Major Threat functions and the ability to perform two described the particularly dangerous To Motorists tasks at the same time. nature of the helicopter emergency • .05—There will be reduced coordina- medical services (HEMS) industry. It was Lawyers in our firm are continuing to tion, reduced ability to track moving noted that the U.S. Federal Aviation receive cases where motorists left the Administration (FAA) incorporated the road and suffered catastrophic, and often-

20 BeasleyAllen.com times fatal, injuries when the vehicle they away from a hazard. By driving the portion of the service line with a copper were driving struck a defective guardrail support posts into asphalt (oftentimes service line at no cost to the resident or system. Guardrail systems are supposed to deeper than 1 ½ inches), the posts are not property owner. The replacements are set redirect a car away from a dangerous area allowed to twist in the ground (which to take place over the next three years, so on the highway (often an embankment or absorbs energy). Instead, the support that by Jan. 1, 2010, replacement lines will a creek, for instance) and absorb the posts can break off and cause splices in be completed for a minimum of 18,000 energy of the car striking it. In this way, the guardrail system to fail. Where splices total households. guardrails are supposed to lessen the fail in this manner, we have observed situ- Residents in those households where a severity of an accident, if not mitigate it ations where sections of the guardrail service line has been replaced will be entirely. Guardrail systems should never system impale the vehicle and kill occu- advised to use filtered water for at least six increase the severity of an accident, but pants inside. months following a service line replace- these defective guardrails are doing Our lawyers are investigating cases ment. Under the proposed deal, officials just that. where vehicle occupants were severely are required to monitor the tap water dis- Based on investigations by our lawyers injured or killed after striking a guardrail tributed through the Flint water system where occupants were killed or were seri- system. If you have any questions about for lead during consecutive six-month ously injured from guardrail systems, we these cases, contact Parker Miller, a periods. Flint came under national scru- have observed two major characteristics. lawyer in our Personal Injury & Products tiny for how local and state leaders The first common characteristic involves a Liability Section, at 800-898-2034 or by responded to the fact that residents’ tap poorly designed guardrail end terminal. email at [email protected]. water was polluted with lead and other End terminals are specially designed end Source: Knoxville News Sentinel contaminants. The January 2016 lawsuit sections of a guardrail system—usually alleged that officials failed to test drinking existing on the approach end of the guard- water for harmful contaminants and treat rail, and they are designed to absorb the the water to control for those con- energy of a car that strikes the approach XV. taminants. end. In this way, the terminal end is sup- ENVIRONMENTAL It was alleged in the complaint that a posed to slow the vehicle down and lessen Michigan state-appointed emergency the severity of an accident. However, a CONCERNS manager decided to switch Flint’s drink- number of roads contain terminal end sec- ing water source from Lake Huron to the tions that are defective, one being the Flint River, regarded as a “dumping breakaway cable terminal. Breakaway Michigan Reaches $87 Million Settlement To ground” for nearby industries, as a cost- cable terminals, which use a cable and a Replace Flint Water Lines cutting measure, according to the suit. breakaway system to absorb car energy, When run through the city’s aging metal- often fail because the terminal design is The State of Michigan has agreed to pay lic pipes, this “corrosive” water ate away too stiff. $87 million to enable the City of Flint to at the pipes, causing lead to leach into the Instead of absorbing the energy of a replace water lines over the next three residents’ drinking water, according to the vehicle as the terminal end section should, years for up to 18,000 households dealing complaint. Federal Government studies proved that with the city’s lead contamination crisis, The settlement comes about two the breakaway cable terminal actually according to a proposed settlement agree- months after Michigan state officials asked penetrates into the passenger compart- ment filed in Michigan federal court. The the Sixth Circuit to overturn Judge Law- ment, resulting in horrific injuries caused proposed settlement resolves a lawsuit son’s order for Flint and state officials to by the guardrail impaling the vehicle (and brought last January by the Natural deliver bottled water to residents whose the occupants inside). Lawyers in our firm Resources Defense Council, American tap water is undrinkable. Officials said the are currently litigating these cases. We Civil Liberties Union and Concerned judge abused his discretion by ordering currently represent one client who lost a Pastors for Social Action against state and the weekly delivery of bottled water to leg when a breakaway cable terminal local officials over the town’s lead-tainted every Flint resident. They argued that impaled her car like a shish kabob stick. water and violations the federal Safe under the injunction, they would need to The second concern we have found Drinking Water Act. deliver approximately 395,000 cases of involves poorly installed guardrail A hearing to approve the settlement is water per week to meet the court’s systems. Poor installation can take a scheduled before U.S. District Judge David requirement, five times more than were number of forms. For instance, poor instal- Lawson. In a lengthy stipulation, the being delivered before the order. lation at splice points (the points where parties agreed they “consider this agree- Under the proposed settlement, the pieces of guardrail sections come ment to be a fair reasonable, and equitable state must continue to operate at least together) can cause the guardrail system resolution of all claims in this case.” The nine sites of distribution for bottled water to break apart when it should hold and settlement requires the state to replace but can discontinue those services by May redirect the vehicle. If the installer fails to lead and galvanized steel water service 1, 2017, if certain conditions are met. Resi- install a guardrail system using the proper lines in the City of Flint with copper water dents can request delivery of bottled height, the guardrail system could actually service lines. The settlement covers the water with a 24-hour turnaround through cause a vehicle to become airborne. cost of conducting excavations to identify a Michigan state helpline. Under the pro- We have also observed situations where the material of the water line at a posal, the Plaintiffs will receive $895,000 the support posts were improperly driven minimum of 18,000 households served by in fees and costs. into asphalt. Guardrail posts along the the Flint Water System. If all or part of the The state officials are represented by guardrail system are supposed to have service line from main line to household Michigan Solicitor General Aaron Lind- some flexibility and bend so they can meter is determined to be lead or galva- strom, and Assistant Attorneys General absorb energy and redirect the vehicle nized steel, officials must replace that Richard S. Kuhl, Nathan A. Gambill,

JereBeasleyReport.com 21 Michael F. Murphy and Joshua O. Booth. icals can be absorbed into bodily organs [email protected] or Ryan.Kral@bea- The Plaintiffs are represented by Dimple just as easily. sleyallen.com. Chaudhary, Jared E. Knicley, Sarah C. If you would like more information Source: Law360.com Tallman and Michael E. Wall of the Natural about these cases, you can contact Grant Resources Defense Council; Michael J. Cofer, a lawyer in our firm’s Toxic Torts Steinberg of the American Civil Liberties Section. He can be reached at 800-898- There Is Concern Over Roundup Weed Union Fund of Michigan; and Glenn M. 2034 or by email at Grant.Cofer@beas- Killer Simmington of the Law Office of Glenn M. leyallen.com. Simmington. Source: AL.com A judge in California recently ruled that The case is Concerned Pastors for the state can require Monsanto to label its Social Action et al. v. Nick A. Khouri et popular weed-killer Roundup as a possible al. (case number 2:16-cv-10277) in the OSHA Delays Rule Limiting Silica Exposure carcinogen, even though Monsanto con- U.S. District Court for the Eastern District tends that the key ingredient, glyphosate, of Michigan. The U.S. Department of Labor (DOL) is has a long history of safe use. The action Source: Law360.com delaying a new rule reducing the by the State of California comes at a time maximum permissible exposure level to when the giant seed and pesticide con- silica dust in certain industries. The glomerate faces dozens of lawsuits from Researchers Discover Extent Of Cancer- 90-day delay will allow the DOL to contact Plaintiffs who allege the company misled Causing Chemicals’ Bioaccumulation those who could be impacted by the rule the public about the risks of Roundup and and to provide educational materials and thus compromised the health of workers. Medical researchers at the UAB School guidance to employers. The Plaintiffs claim that exposure to of Medicine in Birmingham, Alabama, The rule would reduce the current Roundup caused them to develop non- have discovered that perfluroalkyl sub- exposure limit of 100 micrograms per Hodgkin’s lymphoma (NHL). As we stances (PFAS) build up in the brains, cubic meter to 50. It also requires reported last month, unsealed court docu- hearts, livers, bones and skin of mice. employer-covered medical examinations. ments were just released suggesting While researchers were previously aware The rule could have a profound impact on studies attributed to academics were actu- of the fact that PFAS accumulates in the the 2.2 million American workers the ally ghostwritten by Monsanto employees, tissues of living organisms, the full extent Occupational Safety and Health Adminis- and that U.S. regulators based their deter- of this accumulation was not understood. tration (OSHA) estimates are exposed to mination that glyphosate is not a cause of Researchers developed the new way of silica in various industries. Workers are cancer on those studies. tracing the chemicals by replacing a single exposed when they cut, grind, crush, or Recently, Robert F. Kennedy Jr., an envi- fluorine atom in the compounds with fluo- drill silica-containing materials such as ronmental lawyer and activist, discussed rine-18, a radioactive isotop that can be concrete masonry, tile, and rock and these and other issues regarding Roundup traced through the body using medical inhale the resulting crystalline silica dust. with radio host Steve Curwood on Living imaging techniques. Silica is a known carcinogen that can on Earth. Kennedy offered his opinion on These results are startling, because two cause both lung cancer and silicosis. Sili- the inconsistent conclusions of the U.S. “long-chain” versions of the chemicals, cosis is a progressive, debilitating, and Environmental Protection Agency (EPA) PFOA and PFOS, have been used for years incurable disease that is marked by inflam- and Monsanto versus those of the Interna- to manufacture products like non-stick mation and scarring in the form of nodular tional Association for Cancer Research cookware, water-resistant clothing, fire lesions in the upper lobes of the lungs. (IARC) regarding the safety of glyphosate fighting foams, and stain-resistant coatings Silica dust particles can create small cuts and Roundup. for fabrics. In short, these chemicals are in the lung that can scar the lung tissue everywhere, and most people have signifi- when inhaled over a prolonged There are two issues. One is that cant exposure to the chemicals (it is period of time. glyphosate alone is less toxic, we believed that PFAS can be found in the Industry groups argued that OSHA know, and glyphosate in the formu- bloodstream of nearly every person on failed to show significant health risks justi- lation of Roundup. There are surfac- Earth thanks to heavy use in manu- fying a lower threshold without any evi- tants and adjuvants in Roundup facturing). dence that the current level caused harm and particularly a class of surfi- Last year, the U.S. Environmental Pro- to workers. Labor groups lauded the new cants known as tallowamines. That tection Agency (EPA) released a new rule, but also wanted additional regula- makes glyphosate far more toxic announcement warning that PFOS and tions requiring employers to remove than it is alone, in fact, there’s impli- PFOA had been linked to adverse health workers from dangerous exposure situa- cations that it might be 10,000 times effects at lower concentrations that previ- tions with pay if ordered by a doctor. The as toxic when combined with the ously thought harmful. PFOA and PFOS new rule is set to take effect on tallowamines. The reason that the have been linked to higher risk of testicu- Sept. 23, 2017. tallowamines make it more toxic is lar cancer, kidney cancer, developmental Lawyers in our Toxic Torts Section are that they allow the glyphosate to effects to the fetus during pregnancy, liver investigating cases where individuals are penetrate human skin on contact in damage, thyroid effects, and cholesterol diagnosed with silicosis. If you have any very, very high concentrations. changes. While PFOA and PFOS are being questions about this or other severe lung phased out of use in favor of short-chain diseases, contact Chris Boutwell or Ryan We also have studies by the premier, alternative chemicals, most recent studies Kral, lawyers in our Toxic Torts Section, at gold standard cancer research orga- have called this practice into question 800.898.2034 or by email at Chris.Bout- nization on Earth, which is the since it appears that the short-chain chem- International Association for

22 BeasleyAllen.com Cancer Research or IARC, which is John at 800-898-2034 or by email at John. at 800-898-2034 or by email at John.Tom- an organization that is funded by [email protected]. [email protected]. 16 industrialized countries, and Source: Living on Earth –Public Radio International, Sources: Daily Hornet; and Cook County Record most nations, most European coun- April, 2017 tries recognize, and countries all over the world, that nobody really OSHA Delays Rule Limiting Silica Exposure had the resources to measure all of Auto Mechanic Files Benzene Lawsuit In these chemicals that we’re now Illinois The U.S. Department of Labor swimming around in for carcinoge- announced it would delay a new rule nicity, and we needed to have one A lawsuit alleging damages due to reducing the maximum permissible expo- centrally funded and adequately, Benzene exposure was recently filed in sure level to silica dust in certain indus- abundantly funded organization Cook County Circuit Court Illinois by tries. The 90-day delay was deemed and use the highest scientific stan- Steven J. Williams, an auto mechanic who necessary for the Department to contact dards and employ the best scientists has worked in repair shops since 1982. those who could be impacted and to on Earth, and that organization has This man was frequently exposed at his provide educational materials and guid- determined that glyphosate is a work to products containing benzene or ance to employers. probable carcinogen. chlorinated hydrocarbons. He was diag- The rule would halve the current expo- nosed with multiple myeloma, a blood Kennedy also voiced concern over the sure limit of 100 micrograms per cubic cancer that starts in bone marrow. Wil- accuracy of a recent determination by the meter to 50 and also require employer- liams claims his cancer was caused by EPA that there is little risk for most Ameri- covered medical examinations. It could exposure to carcinogens in diesel fuel, cans in the quantities they say they are have a profound impact on the 2.2 million parts washer solvent, paint, belt dress- usually exposed to. He had this to say: American workers the Occupational ings, and more. Safety and Health Administration esti- It’s not accurate, and unfortunately Benzene is a sweet-smelling, flammable mates are exposed to silica in various what the documents that have been chemical that evaporates quickly. Auto industries. Workers are exposed when recently released by Judge Chhabria mechanics are mainly exposed by breath- they cut, grind, crush, or drill silica-con- show is that there was a history of ing it in the air or absorbing it through taining materials such as concrete collusion between the EPA pesticide their skin. Benzene accumulates in the masonry, tile, and rock and inhale the division which was helping Mon- bone marrow and causes the bones to resulting crystalline silica dust. santo cover up the dangers of produce cancerous white blood cells. Silica is a known carcinogen that can glyphosate and Roundup® as well. Benzene is found in many products that cause both lung cancer and silicosis. Sili- The head of the pesticide branch auto mechanics use regularly, such as sol- cosis is a progressive, debilitating, and was a guy named Jess Rowland, vents (degreasers, cleaning agents, etc.) incurable disease that is marked by inflam- who had this very disturbing rela- and car paint. Benzene is also found in mation and scarring in the form of nodular tionship with Monsanto in which gasoline, car exhaust, and cigarette lesions in the upper lobes of the lungs. there are emails that show him smoke. In recent years, several benzene Silica dust particles can create small cuts going to bat for Monsanto. At one exposure lawsuits have resulted in multi- in the lung that can scar the lung tissue point, he tells...A conversation is million dollar jury awards. For example, a when inhaled over a prolonged described in the email in which Jess railroad worker with leukemia was period of time. Rowland pledges to derail an inves- awarded $7.5 million in November 2016. Industry groups argued that OSHA tigation of glyphosate and Roundup The worker was exposed to benzene, cre- failed to show significant health risks justi- by the HHS. We have permission to osote and solvents on the job. fying a lower threshold without any evi- depose Jess Rowland. We’ve also Lawyers for the plaintiff accuse more dence that the current level caused harm deposed David Hayden, who is the than a dozen Defendants of failing to to workers. Labor groups lauded the new Monsanto executive who was coor- provide adequate warnings about the risk rule, but also wanted additional regula- dinating the cover up with the EPA. of cancer from benzene and exposure to tions requiring employers to remove In answer to your question about diesel fuel, despite evidence dating back workers from dangerous exposure situa- whether EPA science is trustworthy, to the 1950s. The lawsuit was filed against tions with pay if ordered by a doctor. The it’s not. And in fact, EPA had a long Ashland Inc., BP Products North America new rule is set to take effect on Septem- history of … That particular divi- Inc., Hess Corp., Safety-Kleen Systems ber 23, 2017. sion is kind of a poster child for Inc., The Sherwin-Williams Co., E.I. Lawyers in our Toxic Torts Section are what we call “agency capture phe- DuPont de Nemours & Co., Axalta Coating investigating cases where individuals are nomenon,” where the regulatory Systems LLC, CRC Industries Inc., Rust- diagnosed with silicosis. If you have any agency becomes captured by the Oleum Corp., Radiator Specialty Co., Heri- questions about this or other severe lung industry that it’s supposed tage Crystal Clean LLC, Shell Oil Co., diseases, please contact Chris Boutwell to regulate. ExxonMobil Corp. and Marathon ([email protected]) or Petroleum Corp. Ryan Kral ([email protected]) John Tomlinson, a lawyer in our Toxic John Tomlinson, a lawyer in our Toxic at 800.898.2034. Torts Section, has filed cases involving Torts Section, has filed and is investigating Source: Law360 Roundup exposure in both state and benzene exposure cases. If you need more federal courts and he is currently investi- information on this litigation, contact John gating other potential cases. If you need more information on this subject contact

JereBeasleyReport.com 23 3M Seeks Dismissal of Water Contamination provisional health advisory for those com- being explosive and two explosions Suit pounds. Then, in 2012, the EPA included resulted in second-degree burns and facial those compounds in its Third Unregulated disfigurement to service members. With the current water crisis in Flint, Contaminant Rule, requiring certain water Given the relatively new nature of e-cig- Michigan making national headlines, the providers across the country to test for arettes, many rules and regulations around public has never been more concerned their presence. On May 19, 2016, the EPA the devices have only recently been final- over the safety of its drinking water. Many issued a new drinking water health advi- ized. For example, the U.S. Food and Drug people, however, are unaware that other sory for PFOS and PFOA at 70 parts per Administration only made official its first chemicals, in addition to lead, can be just trillion over one’s lifetime. regulations for e-cigarettes in 2016. Also as harmful and could present a more wide- The issuance of these new guidelines recent was the U.S. Department of Trans- spread problem. left many water systems nationwide over portation’s decision to formally ban e-ciga- Perfluorinated compounds (PFCs) are a the lifetime limit and scrambling to rette use on commercial flights. group of man-made chemicals most com- address the problem. Lawsuits have been Sources: NPR and The U.S. Navy monly used to make stain-resistant carpet, filed across the country to ensure that clothing, and other fabrics as well as in clean and uncontaminated water is deliv- firefighting foams used at airfields and in a ered to the public. Our firm is represent- number of industrial processes. PFC’s are ing Gadsden’s Water Works and Sewer XVI. slow to degrade in the environment and, Board and is seeking remediation costs An Update On as a result, can persist and accumulate and injunctive relief. over a period of time, eventually migrating If you have any questions about PFOA or Class Action to various sources of drinking water. PFOS contamination, contact Rhon Jones, Litigation Residents in one Philadelphia commu- Rick Stratton, Grant Cofer, or Ryan Kral, nity sued 3M, the manufacturer of these lawyers in our firm’s Toxic Torts section, chemicals, alleging that they migrated at 800-898-2034 or by email at Rhon. There has been a great deal of activity from two former naval airbases into their [email protected], Rick.Stratton@ in class action litigation recently. We will drinking water. 3M is facing a trio of con- beasleyallen.com, Grant.Cofer@beasleyal- include a few of those cases below. solidated class actions alongside other len.com or [email protected]. defendants, such as Tyco International, for Source: Law360.com Salix To Pay $210 Million To Settle manufacturing a firefighting foam that Stock Inflation Class Action contains the cancer-causing chemicals perfluorooctanoic acid (PFOA) and perflu- Shareholders in a proposed class Navy Bans E-cigarettes orooctane sulfonate (PFOS). The firefight- action have asked a New York Federal Court for preliminary approval of a ing foam was used in training activities at The U.S. Navy will be instituting a ban $210 million settlement to end a the two former naval facilities and has on electronic cigarettes onto its ships, sub- lawsuit accusing Salix Pharmaceuti- been used at airfields and other military marines, aircraft, boats, craft and heavy cals Ltd. of inflating stock prices by basis nationwide. equipment because of the devices’ high knowingly misrepresenting the com- 3M said that the plaintiffs could not risk of explosion due to their lithium-ion pany’s wholesale inventory levels. support a negligence claim because it had batteries. The Navy made this known in a The motion asks U.S. District Judge no way of knowing that the foam would statement issued in mid-April. The ban Kimba M. Wood to certify the class of eventually make its way into the residents’ will go into force on May 14 and is only people and entities that held Salix water supplies, accumulate for decades temporary in nature while Navy officials stock between November 2013 and and ultimately pose any health risks. In its review the safety concerns of the elec- November 2014, and to approve as motion to dismiss, Tyco International tronic cigarettes and the lithium-ion bat- class representatives PWCM Master argued that the Navy’s work with govern- teries used to power them. Fund Ltd., Pentwater Equity Opportu- mental authorities to remedy the contami- Individuals who are stationed on land nities Master Fund Ltd., Oceana nation precluded any involvement by will still be allowed to use the devices, but Master Fund Ltd., Pentwater Merger private parties under a provision of the just in designated areas. Those who want Arbitrage Master Fund Ltd., LMA SPC Comprehensive Environmental Response, to take their electronic cigarettes onboard on behalf of the MAP98 Segregated Compensation and Liability Act (CERCLA). a ship will be able to do so, but will have Portfolio, and the City of Fort Lauder- Because the carbon-flourine bonds in to remove the lithium-ion batteries and dale General Employees’ Retire- PFOA and PFOS are stable, they do not keep them stored in a plastic container, ment System. breakdown over time and can readily be according to Navy officials. absorbed and accumulate in humans after Last year, Navy Times reported that the The exact size of the class is repeated exposure. The C8 Health Naval Safety Center called for a full ban of Project, an independent science panel, unknown, but it’s estimated to com- the devices on Navy property, citing their prise thousands of members. Salix determined that kidney and testicular “significant and unacceptable risk.” The cancers have a “probable link” to PFOA had 62 million shares of common Navy reported that 15 separate “mishaps” stock, with average daily trading exposure while other epidemiological occurred between October 2015 and June studies also link ulcerative colitis, thyroid volume in the millions of shares per 15, 2016, which resulted in either injury to week during the class period. disease, high cholesterol, and pregnancy- Navy personnel or “fire/materiel damage.” induced hypertension to these chemicals. The navy reported that eight of these inci- The class representatives and their In 2009, the Environmental Protection dents occurred onboard vessels or air- lawyers say the proposal “represents Agency added PFOS and PFOA to a con- craft. Nine incidents were reported as an excellent result and is in the best taminant candidate list and established a interests of the settlement class,”

24 BeasleyAllen.com which they allege was hurt by the Re Salix Pharmaceuticals Ltd. (case This conduct by a bank is shocking gastrointestinal drug company’s mis- number 1:14-cv-08925) in the U.S. and it can’t be tolerated. The plain- representations. The motion said: District Court for the Southern Dis- tiffs are represented by Derek W. trict of New York. Loeser, Gretchen Freeman Cappio, The proposed $210 million set- Source: Law360.com Daniel P. Mensher and Matthew J. tlement represents a substantial Preusch of Keller Rohrback LLP. Wells percentage of the maximum Wells Fargo To Pay $142 Million To Fargo is represented by David H. Fry damages that lead plaintiff rea- Settle Bogus Accounts Suits and Erin J. Cox of Munger Tolles & sonably believed could be estab- Olson LLP. The case in which the set- lished at trial. This significant Wells Fargo & Co. will pay $142 tlement was reached is Jabbari et. al. benefit to the settlement class million in a class action settlement v. Wells Fargo & Co. et al. (case must be considered in the over fraudulent account generation. number 3:15-cv-02159) in the U.S. Dis- context of the serious risks that The San Francisco-based bank has trict Court for the Northern District further protracted litigation been involved since September in a of California. might lead to no recovery, or to scandal over the generation of more Source: Law360.com a smaller recovery, from defen- than 2 million deposit and credit card dants in this action. accounts that were created without Judge Gives Preliminary Approval To customer knowledge. Originally, a $100 Million Halliburton Settlement The suit arises from two putative $110 million class action settlement securities class actions filed in New was agreed to in March, but Wells Chief U.S. District Judge Barbara M.G. York federal court immediately after Fargo has extended the class period Lynn, a Texas federal judge, has Salix’s stock declined in November for the settlement to May 2002. This granted preliminary approval of a 2014. The suits were consolidated in adds another $32 million to the $100 million securities class action March 2015. It was alleged that Salix settlement. settlement against Halliburton Co. violated the Securities and Exchange over its asbestos liability disclosures. The settlement is just the latest Act when it made false statements The judge scheduled a settlement fair- payout that Wells Fargo has had to about its inventory to inflate its ness hearing to take place in her make since its account generation common stock during the class courtroom on July 31. It will be deter- scandal became public in September period. When Salix reported on Nov. mined whether the terms and condi- of last year. Wells agreed to pay $185 6, 2014, that it had as much as nine tions are “fair, reasonable, and million in a settlement with the Con- months’ worth of inventory on its top adequate to the class,” and whether sumer Financial Protection Bureau, four products, that the complaint they should be approved by the court. the Office of the Comptroller of the alleged the revelation of the “glut” Judge Lynn also set a deadline of Aug. Currency and the Los Angeles City caused the stock price to fall dra- 12 for any class members wishing to Attorney’s Office over claims that the matically. participate in the settlement to bank’s aggressive sales targets and submit a claim form. Her order stated: The motion said the proposed settle- compensation plans drove employees ment was the result of extensive liti- to create more than 2 million deposit At or after the settlement fair- gation, including 2.7 million pages of and credit card accounts that may not ness hearing, the court will documents proffered by Salix and 13 have been authorized by existing determine whether the plan of depositions. The filing also argued customers. allocation proposed by class that a trial would have been risky. It counsel, any application for The March settlement in class action was difficult to prove the misleading attorneys’ fees or reimburse- litigation over the Wells Fargo sales statements amounted to an inten- ment of expenses, and any lead practices scandal brought to a close tional plot to defraud investors, the plaintiff incentive award shall 12 separate lawsuits filed against the motion said, since the errors were be approved. bank. The original proposed settle- due to best estimates of inventory. ment class included anyone who The motion also argued that calculat- claimed Wells Fargo opened an The settlement, which energy giant ing damages would prove difficult, account in their name without Halliburton revealed late last year, because it would require breaking consent, enrolled them in a product puts an end to one of the oldest secu- down how much of the stock price or service, or submitted an applica- rities fraud class actions still hanging drop was due to the alleged fraud and tion for a product or service in their around in U.S. courts. The Erica P. how much was a result of other name without consent between Jan. John Fund, a Milwaukee charitable factors, like the company’s pending 1, 2009, and the execution of the organization that held Halliburton acquirement by Valeant Pharmaceuti- settlement. stock, and others had first sued in cals International Inc. 2002 after Halliburton’s disclosure of However, since the settlement was a $30 million verdict stemming from The class is represented by Salvatore reached, an internal report from asbestos liabilities sent the company’s J. Graziano, John Rizio-Hamilton and Wells Fargo found that the bank had stock price tumbling. Katherine M. Sinderson of Bernstein known about problematic sales prac- Litowitz Berger & Grossmann LLP and tices in its retail banking unit since at Years of infighting among investors Samuel H. Rudman, David Rosenfeld least 2002. and class counsel followed, and Boies and Mark S. Reich of Robbins Geller Schiller took over in 2007. The long- Rudman & Dowd LLP. The case is In running class action alleged Hallibur-

JereBeasleyReport.com 25 ton had artificially inflated its stock Erica P. John Fund is represented by USAA Settles Sales Tax Compensation price by issuing misstatements about David Boies and Carl E. Goldfarb of Class Action For $39 Million its financial liability for asbestos Boies Schiller Flexner LLP and Kim E. claims. Halliburton said there was no Miller, Lewis S. Kahn, Michael Swick The United Services Automobile Asso- evidence the statements at issue had and Neil Rothstein of Kahn Swick & ciation has agreed to pay $39 million an actual impact on its stock price. Foti LLC. The case is Erica P. John to settle a class suit in Florida chal- Fund Inc. v. Halliburton Co. (case lenging its practice of compensating Judge Lynn, in July 2015, granted in number 3:02-cv-01152) in the U.S. policyholders with totaled cars for part the investors’ motion for class District Court for the Northern Dis- the sales tax incurred in purchasing a certification, finding that Halliburton trict of Texas. replacement, rather than determining did not meet its burden of showing tax based on the covered vehicle’s Source: Law360.com that a Dec. 7, 2011, announcement value. The parties asked the court to from the company did not affect its approve the settlement, which pro- $25 Million TCPA Settlement Over stock price. It was disclosed that a vides members with 100 percent of Health Service Faxes Is Approved Baltimore jury found that a Hallibur- the value of their claims plus 8 ton subsidiary, Dresser Industries, A California federal judge has granted percent for claims of prejudgment was liable for $30 million following a preliminary approval to a $25 million interest. The claims are estimated to trial in an asbestos lawsuit. Thereaf- settlement between a health care con- be about $34 million. The settlement ter Halliburton’s shares fell about 40 sulting group and a health care pro- also sets aside about $46,000 in incen- percent. In the case’s first time at the vider in a proposed class action tive payments for the five lead high court, the justices overturned a lawsuit. It was contended that the plaintiffs. Fifth Circuit ruling that the class consulting group sent unsolicited Garrison Property and Casualty Insur- action could not be certified because junk faxes promoting various health ance Co. policyholder Chantal Bastian the investors did not affirmatively services, in violation of the Telephone filed a proposed class action against prove their losses were caused by Hal- Consumer Protection Act. California Garrison and three other USAA-affili- liburton’s alleged misrepresentations. nursing facility Dakota Medical Inc. ated auto insurance companies in filed a proposed TCPA class action in The U.S. Supreme Court ruled there 2013 over their sales-tax compensa- 2014 against Cannon & Associates was no such requirement. The Texas tion for totaled vehicles, later agree- LLC and its former parent company, district court then certified the class, ing to add four named plaintiffs who RehabCare Group Inc., after receiving rejecting Halliburton’s effort to use were insured by the other companies. a number of junk faxes promoting price impact evidence to negate the various seminars manuals, DVDs and investors’ presumed reliance on the The plaintiffs are represented by programs on Medicare and Medicaid statements. The Fifth Circuit affirmed Christopher B. Hall of Hall & Lampros billing. Dakota likewise alleged that that decision, leading to another high LLP and Tracy L. Markham of Avolio the two defendants sent a total of 2.4 court battle, which ended with the & Hanlon PC. The case is Bastian et million junk faxes nationwide Supreme Court declining to overturn al. v. United Services Automobile between 2010 and 2014. The two its landmark Basic v. Levinson deci- Association et al. (case number 3:13- sides reached the $25 million agree- sion but finding that securities defen- cv-1454) in the U.S. District Court for ment late last year. dants may rebut the fraud-on-the- the Middle District of Florida, Jack- sonville Division. market presumption of reliance In giving preliminary appeal, the before the class certification stage by judge agreed to preliminarily certify a Source: Law360.com showing a lack of price impact. class that includes anyone who Class action litigation in our firm is received a successful transmission of The justices found that Halliburton handled by lawyers in our Consumer one or more faxes sent by either did not show a “special justification” Fraud & Commercial Litigation Section. Cannon or RehabCare between July to overturn Basic, which in 1988 Dee Miles heads up the Section and 17, 2010, and Feb. 4, 2014. Dakota established the fraud-on-the-market Michelle Fulmer is the Section Administra- Medical is represented by Donald R. presumption of reliance. That pre- tor. If you need any information on any Fischbach and Mark D. Kruthers of sumption rests on the principle that aspect of class action litigation, contact Dowling Aaron Inc., C. Darryl public, material information about a Michelle at 800-898-2034 or by email at Cordero, Scott O. Luskin, Matthew K. publicly traded company affects the [email protected] and Brown and Leilani E. Livingston of price of the company’s stock and that she will have a lawyer respond to you. Payne & Fears LLP, and Joel S. Magol- investors thereby rely on that infor- nick of Marko & Magolnick PA. The mation when they purchase case is Dakota Medical Inc. v. Rehab- securities. Care Group Inc. et al. (case number The justices found, however, that the 1:14-CV-02081) in the U.S. District energy company should be allowed to Court for the Eastern District of rebut that presumption of reliance California. before class certification by showing Source: Law360.com evidence that an alleged misrepresen- tation did not affect the stock’s price.

26 BeasleyAllen.com XVII. any indication of criminal activity, California Supreme Court Limits Arbitration we would have to take that appli- Waiver Post-Concepcion THE CONSUMER cation down. The California Supreme Court has ruled CORNER By mid-February, the commissioner said that an arbitration agreement that waives it became clear that “there was a pattern the right to public injunctive relief is con- of activity...that was clearly not consistent trary to California public policy and is The Information Of 100,000 U.S. Taxpayers’ with people going on to actually apply for therefore unenforceable under California May Have Been Stolen student loans.” He said that upon further law. The court reversed an appellate review some of that activity was just stu- court’s finding that the U.S. Supreme Internal Revenue Service (IRS) Commis- dents who started but failed to complete Court’s Concepcion decision overshad- sioner John Koskinen says the information the application, while some of it was owed state rules barring some mandatory of up to 100,000 taxpayers may have been indeed criminal. Within weeks of taking arbitration. In a unanimous decision, the stolen in a security breach of an online the tool offline, the IRS and Education California justices rejected Citibank’s con- tool used to apply for federal student aid. Department decided to disable it until tention that, under precedent set forth by Testifying before the Senate Finance Com- October to put stronger protec- the nation’s highest court in AT&T Mobil- mittee, the Commissioner said the IRS tions in place. ity LLC v. Concepcion—which established identified suspicious activity in the files of Applicants can fill out the paper FAFSA that the Federal Arbitration Act (FAA) pre- people who were using a “data retrieval form or use the online version and manu- empts all state-law rules that amount to an tool” as they filled out the Free Applica- ally enter tax data. But student advocates outright ban of arbitration—an arbitration tion for Federal Student Aid (FAFSA). are concerned that both of those options agreement contained in a “credit protec- FAFSA is the form the government and col- will lead to errors. That could lead to stu- tion plan” the bank sold to Sharon McGill leges use to determine financial aid for dents being asked to verify information and other consumers was enforceable. millions of students. with additional documents, a time-con- Instead, the California justices sided The web-based IRS data tool lets people suming process that could take them out with McGill, who had argued that the arbi- upload tax-return information, but the IRS of the running for aid awarded on a first- tration agreement was unenforceable and Education Department disabled it in come, first-served basis. Lawmakers have because it sought to prohibit her from pur- March after identity thieves tried to use asked states to push back their financial suing claims for public injunctive relief in personal information from it to file fraudu- aid deadlines in light of the shutdown, any forum under California’s Unfair Com- lent tax returns. Koskinen told lawmakers since most jurisdictions rely on the FAFSA petition law (UCL) and False Advertising that about 8,000 fraudulent refunds were to dispense grants. Colleges and universi- law, and the Consumer Legal Remedies issued, totaling $30 million. The IRS pre- ties typically want the FAFSA data by Act (CLRA). The California high court vented another 14,000 illegal refunds from March to help them determine use of their pointed out: going out the door and halted action on own aid dollars. 52,000 other returns. The agency is notify- Hundreds of thousands of students got While Concepcion holds that the ing about 100,000 taxpayers of the possi- an early jump on turning in the FAFSA this FAA requires courts to place arbitra- ble breach, although some of the FAFSA season because the window for submit- tion agreements on equal footing applications that were flagged for ting the form opened in October, two with other contracts and to enforce suspicious activity are legitimate, months earlier than usual. That gave them according to their terms, the Koskinen said. higher education experts hope that dis- U.S. Supreme Court qualified that Security concerns about the data abling the data tool will have limited statement with a “savings clause,” retrieval tool first emerged in September impact on students. However, many fear which permits arbitration agree- at the IRS, according to the agency head. that low-income students, without proper ments to be declared unenforceable Officials learned that with relatively little guidance from parents or counselors, are ‘upon such grounds as exist at law stolen information, identity thieves could still working through the application, and or in equity for the revocation of pretend to be students, start the financial the outage could discourage completion. any contract. aid application, and give permission for There is an ongoing criminal investiga- Under the savings clause, then, arbitra- the IRS to populate the form with tax data tion into the breach. The IRS briefed the tion agreements may be invalidated by that could then be used for fraudulent Senate committee on the state of that certain contract defenses, such as fraud or returns. The IRS alerted the Education investigation and the actions the agency unconscionability, but can also be invali- Department in October, the same month has taken in response to the hack. Com- dated by the contract defense at issue that the FAFSA application went live. The missioner Koskinen said the IRS is going here: that a law established for a public agencies monitored the situation, but were through documents and continuing to reason cannot be contravened by a private reluctant to disable a tool that helps fami- analyze the scope of the breach. Neverthe- agreement, the California justices con- lies avoid tedious paperwork. Commis- less, this is a most serious matter. Hope- cluded. The court wrote: sioner Koskinen said: fully, the damages from this breach will be minimized to the extent possible. We agreed with [Education officials] A provision in any contract ... that since we did not have, at that time, Source: AL.com purports to waive ... the statutory any volume of criminal activity that right to seek public injunctive relief rather than shutting it down and under the UCL, the CLRA, or the add to the burden of people apply- False Advertising Law is invalid and ing for financial aid, we, with them, unenforceable under California would monitor that system. But I law. The FAA does not require told them that as soon as there was enforcement of such a provision, in

JereBeasleyReport.com 27 derogation of this generally applica- (case number S224086) in the Supreme for the Advancement of Medical Instru- ble contract defense, merely because Court of the State of California. mentation. It was proved at trial that it the provision has been inserted into Source: Law360.com was widely known inside the companies an arbitration agreement. To con- that their surgical gowns were not compli- clude otherwise would [be] contrary ant with the safety standard. That posed a to Congress’s intent. safety risk to users. Jury Awards $454 Million Against Kimberly- The class was represented by Michael Clark And Halyard In Fraud Suit The California Supreme Court said that Avenatti of Eagan Avenatti. The case is applying this defense to invalidate the A California federal jury found last Bahamas Surgery Center LLC v. Kim- waiver does not modify the FAA, as berly-Clark Corporation et al. (case Citibank argued, but instead implements month that Kimberly-Clark Corp. and its spinoff Halyard Health Inc. misled buyers number 2:14-cv-08390) in the U.S. District the FAA as written. The court pointed out Court for the Central District of California. that the language in Concepcion supports about the impermeability of the compa- Source: Law360.com its analysis. In concluding that the arbitra- nies’ MicroCool surgical gowns. A class of tion provision was unenforceable insofar buyers was awarded $454 million in com- as it purports to waive McGill’s statutory pensatory and punitive damages. right to seek public injunctive relief in any The jury ordered Kimberly-Clark to pay United Airlines Must Learn From Some Very forum, California’s high court overruled a $3,889,327 in compensatory damages and Bad Conduct lower appellate panel, which had found $350 million in punitive damages. In addi- Concepcion established that the FAA pre- tion, jurors ordered Halyard Health to pay By now, most folks have probably heard empts all state-law rules that amount to an $261,445 in compensatory damages and about the incredible situation that outright ban of arbitration. $100 million in punitive damages. occurred on April 9 in which a United Air- McGill had filed the putative class Bahamas Surgery Center’s class action, lines passenger on a flight out of Chicago action in 2011, claiming Citibank’s market- filed in October 2014, claims Kimberly- was forcibly removed from his seat and ing and administration of its “credit pro- Clark and Halyard Health falsely repre- physically dragged off the airplane. The tector” insurance plan violated California’s sented that their MicroCool surgical passenger wasn’t causing trouble; neither consumer protection laws. She sought gowns provided the highest level of liquid was he a threat to air safety. He simply monetary and punitive damages, as well as barrier protection. It was alleged that refused to be “bumped” from the flight— injunctive relief. while the gowns are marketed as “imper- to give up his seat, which he bought and Citibank attempted to force the case meable” and effective against pathogens paid for—in order to make room for four into arbitration based on its contract lan- like Ebola, they put health care workers at United employees whose travel the airline guage, but met only partial success as the substantial risk. The class action was insisted was more important. Yes, in their trial court ordered the arbitration of only a brought on behalf of persons and entities opinion, more important than its portion of the claims, while suspending it in California who purchased the gowns customers. for others based on a rule that agreements between February 2012 and January 2015. The entire incident was caught on to arbitrate claims for public injunctive This appears to have been a classic case camera, filmed by other passengers using relief under the CLRA, UCL or False Adver- of a corporation putting “money and their cellphones. A lawyer for the passen- tising Law are not enforceable in Califor- profits” over safety and customer interest. ger who was removed—a doctor from nia. However, the appellate court The class presented to the court and jury Kentucky named David Dao—said the overturned that order, on the grounds that an assortment of internal company docu- man was physically injured in the alterca- the federal arbitration rules overshadowed ments stating concerns about the quality tion, suffering a broken nose and two state arbitration rules. of the gowns’ seams and testing failures, broken teeth, as well as being publicly In reversing, the California Supreme including emails and chat messages. A May humiliated. Court sent back to the appeals court the 2013 presentation given to Kimberly-Clark United initially claimed the flight was question of whether the remainder of chairman and CEO Tom Falk, saying “the overbooked. Gate crew asked passengers Citibank’s arbitration provision was company had 80 compliance challenges prior to boarding to voluntarily give up enforceable. Glenn Danas of Capstone on gowns that were delaying progress on their seats in exchange for vouchers and Law APC, a lawyer McGill, told Law360: cost savings,” was also presented and was other incentives. However, once the pas- very damaging. sengers were on the plane, the flight crew This unanimous decision invalidat- Additionally, jurors learned of an elec- announced four people still needed to vol- ing forced waivers of consumers’ tronic instant message chat in March 2012 unteer to give up their seats. Eventually right to seek broad injunctive relief in which a Kimberly-Clark senior research the airline resorted to a random lottery, under the California consumer pro- scientist asked a manager at the company’s selecting passengers that would be tection statutes gets the issue right, manufacturing plant in Honduras to create required to deplane. When Dr. Dao and preserves a vital tool in leveling a “pretext for rerunning tests,” telling him refused to leave the plane, saying he had the playing field between consumers “something, anything” would do. The to work the next day, Chicago aviation and corporations, holding the latter biggest concern for the company, accord- police officers forcibly removed him as he accountable. This is a robust, pro- ing to the evidence presented at trial, screamed, eventually dragging his body consumer ruling, and we’re proud were problems with the gowns’ sleeve down the aisle and off the plane in front of to have played a part in obtaining it. seams actually coming apart. other horrified passengers. AAMI Level 4 protection is the top rank Making matters worse, it later came to McGill is represented by Glenn A. Danas for protective apparel, appropriate for situ- light that United was requiring passen- and Liana Carol Carter of Capstone Law ations where there’s a high-risk of infec- gers—its paying customers—to give up APC. The case is McGill v. Citibank NA, tion. The standard is set by the Association their seats to off-duty United flight crew,

28 BeasleyAllen.com whose schedules were apparently more agency’s enforcement actions last month the FDA said. “Additionally, both pre- important to the airline. from Law360. sentations stated there were no Video of the incident quickly went viral serious injuries or deaths directly online, sparking international outrage. Recalled St. Jude Defibrillators related to lithium cluster formations,” United CEO Oscar Munoz offered a ludi- Implanted in Patients the FDA said, noting there had been crous and insulting initial “apology,” in at least one death by that time. which he said the airline was sorry for St. Jude Medical—which was “having to re-accommodate these custom- acquired by Abbott Laboratories on In addition to the battery problems, ers,” fanning the flames of indignation and Jan. 4—continued to ship out heart the FDA again took the medical- causing United stock to plunge. On April defibrillators with batteries prone to device maker to task for cybersecu- 11, Munoz finally issued a statement failing early, despite a recall in rity issues with its implantable heart calling the event “truly horrific,” pledging October, and seven cardiac defibrilla- devices. This is the second time in to take full responsibility and make things tors were implanted in patients soon 2017 that the agency has faulted St. right with its customers, as well as after the recall, according to a Jude for cybersecurity problems with announcing an internal investigation into warning letter sent April 12. The the devices; in January, the FDA the incident. company also didn’t tell its own man- warned that its smart pacemakers and Sens. John Thune (R-S.D.) and Bill agement and medical advisory review defibrillators may be vulnerable to Nelson (D-Fla.), who are ranking members boards about the full scope of the hacking, after St. Jude had forcefully of the Committee on Commerce, Science battery issue, including the death of a denied such reports late last summer. and Transportation, called for United and patient whose defibrillator battery Implantable cardiac devices that use the Chicago Department of Aviation to failed prematurely several years ago, St. Jude’s Merlin@home transceiver to provide an explanation for the events the FDA said. St. Jude in the October communicate radio frequency signals leading to the forcible removal of the pas- recall had warned that batteries in that export device data “can be vul- senger to their committee by April 20. some of its implantable heart devices nerable to cybersecurity intrusions Rather than meeting that deadline, Munoz can short-circuit and run out of juice and exploits,” the FDA said in a Jan. sent a letter to the senators saying its inter- earlier than anticipated, which it said 10 safety alert. That could enable a nal investigation is still underway, and at the time had been linked to two hacker to access the device by chang- promised answers by April 27. Ginger deaths, one in the U.S. The problem ing the programming demands, Evans, Commissioner of the Chicago Avia- stems from lithium deposits that can which could cause the battery to tion Department, says her department will form within the devices’ batteries, drain rapidly, change pace, or give have its own report ready April 26. The potentially causing short-circuits that out shocks, the FDA said, noting that senators answered by saying the delay is can lead to battery failure with little there hadn’t been reports of such “unacceptable.” notice, in some cases within 24 hours tampering so far. In the warning It is hard to believe either the airline or of the patient receiving the telltale letter, the FDA chided St. Jude for the aviation department will come up vibrartory alert, according to the how it handled its corrective and pre- with an acceptable explanation for these FDA. Normally, the devices give three ventive action procedures for the recent events, no matter how much time months’ warning, the agency said cybersecurity issue. The agency said: at the time. they are given to do so. United did settle Your firm conducted a risk with Dr. Dao last week by paying a confi- In its warning letter, the FDA said that assessment and a corrective dential amount in settlement of all claims. it had reviewed a number of the com- action outside of your CAPA Sources: The Huffington Post, The New York Times, pany’s product analysis reports system. Your firm did not Washington Post, BoardingArea.com between 2011 and 2014, which confirm all required corrective showed that the battery supplier and preventive actions were Greatbatch—now Integer Holdings completed, including a full root Information From Recent FDA Warning Corp.—had shown evidence that cause investigation and the Letters lithium clusters caused the battery to identification of actions to drain too fast. But despite that evi- correct and prevent recurrence Cybersecurity and battery problems dence, St. Jude repeatedly concluded of potential cybersecurity vul- with heart devices continue to trouble that the cause of the batteries’ failure nerabilities, as required by your Abbott’s St. Jude Medical Inc., whose couldn’t be determined and classed CAPA procedures. devices were still being implanted in those failures as “unconfirmed,” the patients despite a recall over faulty batter- FDA said. ies last fall. This is according to a recent Medical Food Company Didn’t Clear warning letter from the U.S. Food and The company didn’t include these Study Drug Administration (FDA). Also, cyberse- unconfirmed cases in its risk evalua- curity issues with smart heart devices still tion and didn’t consider that those The FDA aimed another warning haven’t been handled to agency’s satisfac- cases could have been shorts, leading letter at Targeted Medical Pharma tion, which warned about the problem it to drastically underestimate the Inc., a maker of amino acid-based early in the year. The FDA also scolded a hazard, the FDA said. St. Jude’s man- medical foods. A medical food is medical food company for not getting the agement and medical advisory board defined as food eaten under a doc- necessary clearance to study a new had been presented with information tor’s supervision that is meant to product, and found a stomach-churning about the premature battery failure in manage the nutritional aspects of a array of pest problems at a Los Angeles 2014, but the presentations likewise disease or condition. The company bakery. The following is a roundup of the didn’t include the unconfirmed cases, had sponsored clinical investigations

JereBeasleyReport.com 29 of a redacted drug, but without sub- on an aluminum tray also seemed to dleby have agreed to maintain an mitting a required investigational rub off on the croissant dough. enhanced compliance program to new drug, or IND, application to the Source: Law360.com ensure compliance with the U.S. Con- agency, the FDA wrote. Targeted sumer Product Safety Act. Viking will Medical had responded to the FDA Viking Pays $4.65 Million Civil Penalty also maintain a related system of after it visited in June and July by For Defective Gas Ranges internal controls and procedures, the saying that the medical food is used CPSC said. The food equipment man- to treat nutritional deficiencies from Viking Range LLC and its parent ufacturing giant on Feb. 28 reported pain and inflammation and that it had company, The Middleby Corp., have net profits for fiscal 2016 of $284 never been the company’s intention agreed to pay a $4.65 million civil million, compared with $192 million to apply for a new drug application or penalty for failure to report defective in fiscal 2015. Middleby’s interna- market the food as a drug, according gas ranges. The civil penalty settles tional brands, in addition to Viking, to the letter. However, there are no claims that Greenwood, Mississippi- include Aga Ranges in Great Britain, distinctive nutritional requirements based Viking and Elgin, Illinois-based Beech Ovens in Australia and La for people with the unnamed condi- Middleby failed to immediately report Cornue cookers in France. tion in question, the FDA said, making to the U.S. Consumer Product Safety Source: Law360.com this product not a medical food. Commission (CPSC) that the gas ranges contained a defect that could Instead, the product meets the defini- create a substantial product hazard tion of a drug under the Food, Drug and an unreasonable risk of serious XVIII. and Cosmetics Act, the FDA said, and injury, according to the agency. The thus requires an IND before a clinical CPSC said: RECALLS UPDATE investigation can begin. The agency Several consumers called 911 also noted that the studies were We are again reported a large number of for assistance when they discov- meant to compare the product to a safety-related recalls. We have included ered that the ranges had turned nonsteroidal anti-inflammatory drug. some of the more significant recalls that on spontaneously and could not The FDA’s letter mentioned that a Tar- were issued in April. If more information be turned off or disconnected. geted Medical employee had con- is needed on any of the recalls, readers are Viking knew of this informa- tacted the agency before the studies encouraged to contact Shanna Malone, the tion, but failed to notify CPSC and was advised to apply for an IND. Executive Editor of the Report. We would immediately of the defect or The agency said: also like to know if we have missed any risk posed by the ranges, as safety recalls that should have been There are no FDA records to required by federal law. indicate that Targeted Medical included in this issue. Pharma Inc. submitted an IND application before conducting The CPSC said that between 2008 and 2014, Viking received 170 incident the investigations. Ford Recalls F-250 Trucks Over Rollaway reports of ranges that had turned on Dangers spontaneously and could not be Just under 300 patients were enrolled turned off using their control knobs, Ford is recalling about 52,600 of its 2017 in the studies and were given the resulting in extreme surface tempera- Ford F-250 gasoline-powered 6.2-liter drug product twice a day for 28 days, tures posing a burn hazard to con- trucks to fix problems that can cause the the FDA said. sumers. The incidents include reports trucks to roll away and hit anything the by two consumers who said they trucks want to hit. Ford didn’t release Rat Feces, Cockroaches and Flying were unable to turn off the Viking much information but did say the F-250 Birds Found at Croissant Maker range using the controls and were trucks run on gasoline (not diesel) and burned while attempting to discon- FDA inspectors found rat feces and can roll away even when the trucks are in nect the power source, according to live cockroaches during a November PARK. The automaker blames the rollaway the agency. Viking eventually told the inspection of a wholesale bakery in risk on a damaged park rod actuating plate commission that it had received five Los Angeles, according to another that may not move the automatic transmis- reports of ranges that had turned on FDA warning letter. Three birds also sion into PARK. Although the trucks can spontaneously and caused damage to flew through the warehouse of C & B move with the gear shifter indicating property in the areas surrounding Croissants Corp., which had hap- PARK, Ford says no accidents or injuries the ranges. pened before during another visit in have been reported related to the F-250 2010, the FDA said. Perhaps relatedly, Viking recalled a total of 52,000 trucks. However, the parking brake should the inspectors spotted what seemed ranges in May 2015, according to the always be applied after shifting the truck to be bird droppings on boxes of mar- CPSC. They were sold for between into PARK. garine stored in a walk-in cooler. In $4,000 and $13,000 at retail appliance All the recalled 2017 F-250 trucks were the warning letter, the agency recited stores nationwide—including Abt, built in Kentucky between October 9, a litany of other food hygiene and Ferguson, Morrison’s, Pacific Sales 2015, and March 30, 2017. Ford says about cleaning issues, such as the compa- and P.C. Richard & Son—from July 48,421 of the trucks are in the U.S. and ny’s practice of storing uncovered 2007 through June 2014. another 4,143 are in Canada. The auto- dough and margarine. A dark residue maker didn’t mention when the 2017 F-250 In addition to paying the $4.65 recall will begin. Ford dealers will inspect million civil penalty, Viking and Mid- and replace the park rod actuating plates,

30 BeasleyAllen.com if needed. CarComplaints.com will update functioning Takata air bag inflator. The reimbursed for previous repair expenses. its site when additional recall details are company also agreed to create an $850 No accidents or injuries have been released, but F-250 owners with questions million fund to benefit automakers that reported so far, according to the com- should call Ford at 866-436-7332 and ask received the falsified data and reports or paines. Kia extended warranties on the about recall number 17C06. that purchased the potentially dangerous engines in May, but decided to voluntarily inflators. Takata further agreed to improve recall the cars because of anticipated risk its compliance program and to appoint an concerns. Toyota Recalls 2.9 Million Cars Worldwide independent monitor who will report to This is Hyundai’s second recall in two With Takata Air Bags the DOJ for three years about Takata’s years for the same issue. In September compliance with legal and ethical obliga- 2015, the company recalled nearly half a Toyota Motor Corp. is recalling another tions. A little more than a year ago, the million Sonatas because metallic debris 2.9 million cars around the world—though National Highway Traffic Safety Adminis- may have been left in the vehicles’ engines not in North America—that are equipped tration (NHTSA) levied a $200 million fine at the same Alabama factory. The auto- with the now-infamous and potentially on Takata—its largest ever—in a deal that maker said at the time that its model year deadly Takata air bag inflators, which have saw the company admit that it failed to tell 2011 and 2012 Sonatas were the first of its been linked to at least 11 deaths in the U.S. the agency about the defect despite vehicles to be fitted with engines made at The recall affects 1.16 million vehicles knowing about it and withholding impor- the plant. Hyundai changed its process for sold in regions including Oceania and the tant information. At the time, NHTSA esti- removing debris from the crankshaft in Middle East, and about 750,000 vehicles in mated that the exploding inflators had April 2012. Japan, 650,000 in China and an additional caused about 98 injuries. A sprawling mul- NHTSA first raised the Sonata issue with 350,000 in Europe and covers the Auris, tidistrict litigation involving injured Hyundai in June 2015, but the automaker RAV4, Corolla Axio and other models, victims and people whose car values have refrained from taking action on a recall according to media reports. Takata air decreased is ongoing in Florida federal because, it said, the vast majority of war- bags prompted the largest auto recall in court. Takata is one of the Defendants. ranty claims it received showed that cus- U.S. history and the company has faced tomers were responding to the noise massive global recalls of its air bag infla- coming from their engines, or the vehi- tors, which allegedly had a tendency to Hyundai And Kia Recall 1.4 Million Vehicles cle’s check engine light, and bringing explode. The cheap but volatile ammo- For Stalling Engine Risk their vehicles to service as a result of nium nitrate that inflates the bags can those warnings. But after NHTSA’s Office misfire, especially in humid conditions, Kia Motor Corp. and its parent company of Defects Investigation expressed blasting chemicals and shrapnel at passen- Hyundai Motor Co. are recalling 1.4 concern that the cars could stall at higher gers and drivers. million vehicles in the U.S., Canada and speeds, Hyundai decided to conduct the The Japanese auto parts manufacturer South Korea due to a risk that the engines recall, according to the report. in February pled guilty to one count of can fail and stall, potentially causing a wire fraud in Michigan federal court as crash, according to documents posted by part of its plea deal with prosecutors over the National Highway Traffic Safety Tesla Issues Parking Brake Recall the company’s potentially deadly air bag Administration (NHTSA). According to the inflators. Takata’s plea stems from the set- automakers, metal debris left over from Tesla is recalling 53,000 vehicles after tlement reached with the U.S. Department engine manufacturing can clog oil to bear- discovering a potential issue with the elec- of Justice (DOJ) in January that also ings, which causes temperatures to rise in tric parking brake on certain Model S and requires the company to pay nearly $1 the engines and the bearings to fail, which Model X vehicles that might cause the billion for falsifying testing data and could make the car stall while running. A brake to stick. Tesla says the electronic reports about its inflators and to repay worn connecting rod bearing will also parking brakes on Model S and Model X anyone injured by them. The settlement, make a knocking noise from the engine, vehicles built between February and which Takata announced Jan. 13, resolved causing warning lights in the dashboard, October 2016 may contain a small gear the DOJ investigation into the company according to the documents. “If the warn- that could have been manufactured and its affiliates. That same day, the DOJ ings are ignored and the vehicle is contin- improperly by a third-party supplier, made a superseding filing that charged ued to be driven, the bearing may fail and according to the statement. The company Takata with the one wire fraud count it the vehicle could stall while in motion,” said while they haven’t seen any injuries agreed to plead guilty to. The scheme Kia said in one document. The recall or accidents related to the issue, they will started sometime around 2000 and ran for includes 2013 and 2014 Hyundai Santa Fe replace the parts on all potentially at least 15 years, with Takata fraudulently Sports and Sonatas, as well as 2011 affected vehicles. The statement on the persuading customers to buy air bag through 2014 Kia Optimas, Kia Sportages company’s website said: systems by giving them information that from 2011 to 2013 and Kia Sorentos from hid the accurate test results for the air bag 2012 through 2014. If this gear were to break, the inflators, prosecutors said. To further that The recalled cars all have either 2-Liter parking brake would continue to plan, Takata made an interstate wire trans- or 2.4-Liter engines, and the vehicles in keep the car from moving, but the fer of about $43,000 from Pennsylvania to the U.S. were all made at a Hyundai plant parking brake would then be stuck Detroit, the DOJ said. in Montgomery, Alabama. The companies in place. There have been no reports Under the terms of the proposed deal, will be mailing car owners starting May 19 of the parking brake system failing Takata also agreed to pay a $25 million and telling them to bring their cars to a to hold a parked vehicle or failing to criminal fine and to establish a $125 dealer, which will inspect and replace the stop a vehicle in an emergency as a million restitution fund for people who engine assembly, if necessary. The repairs result of this condition, and this were injured or will be injured by a mal- will be free of charge. Owners also will be

JereBeasleyReport.com 31 part has no impact on the car’s has received 19 reports of the ESC in the posing fall and injury hazards to riders. regular braking systems. model truck and cars catching fire. No This recall involves Chromag bicycle injuries or property damage has been stems used to clamp the fork steerer and/ Tesla is sending emails to affected cus- reported. or handlebars. The recalled stems include tomers to give them instructions on how The vehicles were sold at Horizon models BZA, Director, HiFi and Ranger. to get the electric parking brake replaced. Hobby stores nationwide and online at Only stems with a “Z” marked inside the It also says owners of the affected recalls www.horizonhobby.com from October bolt head are included in this recall. will receive an official recall notice by 2016 through December 2016 for about “Chromag” and the model name are mail. The company says it can begin $180. Consumers should immediately stop printed on the stems. The stems were replacing parts immediately and is using the recalled product and contact sold separately from bicycles. Bolts used working with its supplier to ensure it has Horizon Hobby for instructions on receiv- in the stems are 6 mm in diameter and 20 enough parts to address all affected vehi- ing a free replacement ESC. Consumer mm in length. The stems were sold in cles by October. “In the meantime, it is Contact: Horizon Hobby at 800-338-4639 various colors including black, red, blue, safe to continue regular use of your from 8 a.m. to 7 p.m. CT Monday through gold, purple and silver. The firm vehicle,” the statement said. Less than 5 Friday, 8 a.m. to 5 P.M. CT on Saturday, has received three reports of the clamp- percent of the 53,000 vehicles being and 12 p.m. to 5 p.m. CT on Sunday or ing bolts breaking. No injuries have recalled may be affected by the issue, but online at www.horizonhobby.com and been reported. the recall extends to all out of an abun- click on Product Recalls at the bottom of The bikes were sold at Arts Cyclery, dance of caution, Tesla said. “Because of the page for more information. Photos Beatchwood Cycles, Beat Cycles, Bread- the design of the gear, it is difficult to tell available here https://www.cpsc.gov/ winner Cycles, Blazin Saddles, Harpers, exactly which vehicles are affected,” the Recalls/2017/horizon-hobby-recalls- Quality Bicycle Products, The Bike Hub statement said. remote-controlled-model-vehicles and Squatch Cycles nationwide or online Servicing and repair of the brakes will at www.chromagbikes.com from Novem- take less than 45 minutes, the statement ber 2016 through March 2017 for about said. The recall announcement came one $120 for the stem. Consumers should day after Tesla was hit with a punitive Polaris Issues More Vehicle Recalls For Crash, Fire And Burn Hazards immediately stop using bicycles with the class action in California federal court recalled stems and contact Chromag for alleging its 2016-2017 models weren’t Polaris Industries, a Minnesota powers- free replacement bolts for the stem. Con- updated with standard safety features and ports leader has announced two more sumer Contact: Chromag Bikes at 800- premium enhanced Autopilot software as recalls due to fire, burn and crash hazards. 380-4102 from 9 a.m. to 5 p.m. PT Monday promised in a December 2016 software The first recall involves all 2015 Polaris through Thursday, email info@chromag- update. Tesla also announced a settlement Ranger XP 900, XP 900 EPS, and CREW bikes.com or online at www.chromag- had been reached with Sterling Anderson, 900 recreational off-highway vehicles bikes.com and click on Stem Bolt Recall at a former director of their Autopilot (ROVs). The Consumer Product Safety the top of the page for more information. program, and his new company Aurora Commission (CPSC) said a heat shield can Photos available at https://www.cpsc.gov/ Innovations, ending a trade secrets suit fall off the vehicle, posing fire and burn Recalls/2017/Chromag-Bicycle-Stems- filed in January. hazards to riders. Polaris has received 13 Recalled-by-Riser-Holdings/ incident reports involving the ROVs, including five reports of fires. No injuries Horizon Hobby Recalls Remote-Controlled have been reported. Look Cycle Recalls Aerostems And Road Model Vehicles Due To Fire Hazard The other recall includes 2017 Polaris Bikes Due To Fall And Crash Hazards Sportsman 450, 570, 850, 1000 and Scram- Horizon Hobby LLC, of Champaign, Ill., bler 1000 model ATVs. Polaris is aware of Hawley LLC, of Lexington, South Caro- has recalled about 18,600 ECX Circuit, 15 reports of the electronic power steer- lina, has recalled about 800 Look Cycle Ruckus, and Torment remote-controlled ing unit malfunctioning. No injuries have road bikes and Aerostems. The stainless model vehicles. The vehicle’s electronic been reported. steel clamp that secures the stem to the speed control (ESC) can fail and short The company is contacting all known handlebars can corrode and break, posing circuit, posing a fire hazard. The recall purchasers about the recalls and allowing a fall and crash hazard. This recall involves involves the Dynamite 40-Amp FWD REV customers to schedule a free repair to Look Cycle Aerostems sold either as an Brushed ESC—DYNS2201. It is the Elec- correct the problems. The vehicles were after-market component or installed as tronic Speed Control (ESC) that comes in made in both the U.S. and Mexico. Polaris original equipment on Look Cycle model the remote controlled hobby model vehi- has issued more than a dozen recalls since 695 and 795 road bikes for model years cles ECX 1/10 LiPo Circuit, Ruckus and 2015, will release its first quarter 2017. 2014 through 2017. The Look Aerostems Torment models with the following are made of black carbon fiber material models numbers: ECX03130T1, with a black steel clamp around the han- ECX03130T2, ECX03131T1, ECX03131T2, dlebars. Recalled models have either no Chromag Bicycle Stems Recalled By Riser ECX03133T1, ECX03133T2, ECX03154. number or the number 380706 printed in Holdings Due To Fall and Injury Hazards The model numbers can be found on the white on the bottom of the clamp. A com- product box or in the owner’s manual for About 100 Chromag bicycle stems have plete list of photos of the recalled stems each vehicle. The model vehicles measure been recalled by Riser Holdings Ltd., of and bike models can be found on the com- about 18 inches in length and 12 inches in Canada, dba Chromag Bikes. The clamp- pany’s website at http://www.lookcycle. width and are hobby grade remote control ing bolts that secure the stem to the fork com/en/safety-notice. The company has models for ages 14 and up. Horizon Hobby steerer and/or the handlebars can break, received one report of the stainless steel

32 BeasleyAllen.com clamp on an Aerostem breaking. No inju- available at https://www.cpsc.gov/ breaks in steer supports, resulting in one ries have been reported. Recalls/2017/Marin-Mountain-Bikes- report of scrapes and bruises from a fall. The bikes were sold at independent Recalls-Bicycles The scooters were sold at Lajolla Swim bike stores nationwide from July 2013 and Sport, Nyce Wheels, San Francyclo through December 2016 for about $500 and other sporting goods stores nation- for the stems sold individually and for Razor Recalls RipStik Motorized Caster wide and online at Amazon.com and between $5,500 and $16,000 installed as Boards Due To Fall Hazard Xootr.com from November 2016 through original equipment on Look Cycle road January 2017 for about $270. Consumers 695 and 795 road racing bicycles. Consum- Razor USA LLC, of Cerritos, California, should immediately stop using the ers should immediately stop using bicycles has recalled about 158,000 RipStik electric recalled scooters and contact the firm to with the recalled Aerostems and return motorized caster boards. The rear wheel receive the free repair. Contact Xootr at them to the place of purchase for a free can stop rotating and lock up while in use, 800-816-2724 from 9 a.m. to 5 p.m. ET repair. Consumers unable to return their posing a fall hazard. This recall involves Monday through Friday, by email at bicycles should contact Look Cycle for Razor RipStik electric motorized caster [email protected] or online at www. instructions on receiving a free repair. boards. The boards have two wheels, a xootr.com and click on “Recall Informa- Contact Look Cycle at 800-822-1980 from hub motor and a lithium ion battery. They tion” for more information. Photos avail- 8 a.m. to 5 p.m. ET Monday through have a wireless digital hand remote that able at https://www.cpsc.gov/ Friday, email at aerostemrecall@hawleyl- controls the speed up to 10 mph. The Recalls/2017/Xootr-Recalls-Adult- ambert.com or online at http://www.look- manufacturing date is on the bar code Kick-Scooters cycle.com/ click on the Safety Notice tab label located on the bottom of the product for more information. Photos available at: and Razor USA LLC is embossed on the https://cpsc.gov/Recalls/2017/Look-Cycle- bottom. “RipStik” is printed on the top of Cost Plus World Market Recalls Windsor- Recalls-Aerostems--and-Road-Bikes the board. They are blue and black in Style Dining Chairs Due To Fall Hazard color. Razor has received more than 700 reports of the rear wheel locking up, Cost Plus Management Services Inc., of Marin Mountain Bikes Recalls Bicycles Due resulting in four injuries, including one Alameda, California, has recalled about To Fall And Crash Hazards loose tooth and three scrapes and bruises. 4,700. Stafford Windsor-style dining The ripstiks were sold at Target, Toys R chairs. The legs on the chairs can break, Marin Mountain Bikes Inc., of Novato, Us, Walmart, and other stores nationwide posing a fall hazard to consumers. This California, has recalled about 370 Pine and online at Amazon.com, Razor.com, recall involves wooden Stafford Windsor- Mountain bicycles. An additional 100 are Target.com, toysrus.com and Walmart.com style dining chairs with four legs. The recalled that were sold in Canada. The and other websites from February 2016 chairs have a walnut finish and are rigid front forks on these recalled bikes through April 2017 for about $180. Con- intended for indoor use. Purchase order can bend or break during use or while sumers should immediately stop using the number 200519526, 400519526, jumping, causing the rider to lose control, recalled caster boards and contact Razor 200519525, 400519525, 200524057, posing fall and crash hazards to the user. to receive a free repair kit. Contact Razor 200536057, 200536058 or 400524058 is This recall involves two Marin Mountain toll-free at 866-467-2967 from 8 a.m. to 5 printed on the UPC label attached to the bicycle model years and model names: p.m. PT Monday through Friday or online underside of the chair seat. The comapny 2016 Pine Mountain 1 and 2017 Pine at www.Razor.com and click on “Recall has received three reports of in-store Mountain bicycles. The bicycles were sold Information” for more information. Photos display chair legs breaking and one report in five frame sizes and in one basic color available here https://cpsc.gov/ of the chair leg bowing out. No injuries scheme (silver painted frame with orange Recalls/2017/Razor-Recalls-RipStik-Motor- have been reported. painted fork.) The model name “Pine ized-Caster-Boards The chairs were sold exclusively at Cost Mountain 1” (2016) or “Pine Mountain” Plus World Market and World Market (2017) is printed on the top tube of the stores nationwide and online at www. frame and the downtube of the frame has Xootr Recalls Adult Kick Scooters Due To worldmarket.com from June 2016 through a “MARIN” decal. The company has Fall Hazard December 2016 for about $100. Consum- received four reports of bent bicycle forks ers should immediately stop using the including one report in the United States About 3,000 Xootr adult kick scooters recalled chairs and return them to any and three in other countries. No injuries have been recalled by Xootr of Old Forge, Cost Plus World Market or World Market have been reported. Pennsylvania. The steer support can break store for a free replacement chair. Contact The bikes were sold at independent during normal use, posing a fall hazard to Cost Plus toll-free at 877-967-5362 from 7 bicycle stores nationwide from December the user. This recall involves all Xootr a.m. to midnight ET daily, or online at 2015 through February 2017 for about adult kick scooters with the QuickClick www.worldmarket.com and click on $1,000. Consumers should immediately push-button latching mechanism. The “Product Recalls” for more information. stop using the recalled mountain bikes silver scooters are 30 inches long by 10 Photos available here: https://cpsc.gov/ and contact the company for instructions inches wide, and have a handlebar height Recalls/2017/Cost-Plus-World-Market- on receiving a replacement bicycle fork of 36 inches. The Xootr logo is on the Recalls-Windsor-Style-Dining-Chairs and scheduling a free repair. Contact deck and lower section of the handlebar. Marin Bikes at 800-222-7557 from 8 a.m. to The scooters have a plastic, wood or metal 5 p.m. PT Monday through Friday or deck, and can be identified by a black online at www.marinbikes.com and click push button located on the steer support. on the “recalls/safety” link at the bottom The company has received six reports of of the page for more information. Photos

JereBeasleyReport.com 33 Bosch Solar Services Recalls Solar property damage to the counter top. No instructions on returning the sweaters for Panels Due To Fire Hazard injuries have been reported. a $75 refund. Consumer Contact: FatFace The food dehydrators were sold at at 800-585-0178 from 4 a.m. to 12:30 p.m. Bosch Solar Energy Corporation, San Kohl’s stores nationwide and online at ET Monday through Friday, 5 a.m. to 1 Mateo, California, has recalled about Amazon.com from June 2016 through Feb- p.m. ET Saturday and 6 a.m. to 12 p.m. ET 51,000 Roof-mounted Bosch solar panels. ruary 2017 for between $40 and $50. Con- on Sunday, email at usproductqueries@ The solar panels can overheat, posing a sumers should immediately stop using the fatface.com with “Product Recall” as the risk of fire. This recall involves Roof- recalled food dehydrators and contact email subject or online at http://us.fatface. Mounted Bosch Photovoltaic Solar Greenfield for instructions on returning com and click on the “Important Notice” Modules with model number c-Si M 60 the recalled food dehydrators with a tab for more information. Photos available NA30119. Bosch solar modules are photo- prepaid shipping label for a free replace- here https://cpsc.gov/Recalls/2017/Wom- voltaic solar panels used to generate elec- ment or full refund. Contact Greenfield ens-Sweaters-Recalled-by-FatFace tricity. Each module measures toll-free at 877-881-0065 from 12 p.m. to 7 approximately 65 inches by 39 inches by p.m. ET Monday through Friday, email at 1.65 inches, and weighs just less than 42 [email protected] Customatic Beds Recalls Adjustable Beds pounds. The solar cells are housed in a or online at www.greenfieldworld.com Due To Electric Shock Hazard glass-foil laminate framed by an anodized and click on the “Product Recall” link at aluminum profile. The output power of the bottom of the page for more informa- PPJ, LLC; d.b.a Customatic Beds of the panel is 245 watt peak. tion. Photos available here https://cpsc. Natick, Massachusetts, has recalled about The panels were sold at commercial gov/Recalls/2017/Food-Dehydrators- 50,000 adjustable beds. The bed’s side- installers nationwide from October 2011 Recalled-by-Greenfield-World-Trade mounted AC outlets can be incorrectly through May 2013 for about $300 per wired, posing an electric shock hazard to panel. Consumers should contact their consumers. This recall involves the bases installer to determine if their solar panels Women’s Sweaters Recalled By FatFace of Customatic adjustable beds. These are the model being recalled. If it is, cus- Due To Violation Of Federal Flammability power foundations were offered in all bed tomers should contact Bosch to arrange Standard sizes and were sold with handheld remote for free replacement. Contact Bosch toll- controls, allowing the head and/or the free at 855-866-8470 from 7 a.m. to 7 p.m. About 400 Women’s overhead and foot of the bed mattress to be moved up CT Monday through Friday, or email zip-up sweaters have been recalled by and down. These bases also have a side [email protected] or online at www. FatFace Corp., of Wilmington, Del. The mounted AC outlet. The model numbers bosch-solarenergy.com and click on recalled women’s sweaters fail to meet can be found on the metal frame near the “Recall Notice” at the bottom of the page federal flammability standards for cloth- foot of the bed and are listed below. for more information and to register for ing textiles, posing a risk of burn injuries. The beds were sold at Sleepy’s and other free replacement. Photos available at This recall involves two styles of FatFace mattress stores nationwide from June 2012 https://cpsc.gov/Recalls/2017/Bosch- women’s sweaters: overhead Cowes (style through January 2017 for about $1,500. Solar-Services-Recalls-Solar-Panels number 918043) and zip-up (style number Consumers should immediately stop using 918041). The style numbers are printed on the AC plug on the side of the bed and a care label on the inside seam of the contact Customatic Beds to arrange for a Food Dehydrators Recalled By Greenfield sweaters. The Overhead Cowes sweater is free inspection and repair. Contact Cus- World Trade Due To Fire And Burn Hazards 97 percent cotton and 3 percent polyester tomatic Beds toll-free at 844-815-9023 sold in ivory. This sweater has a 3.5 inch from 9 a.m. through 9 p.m. ET Monday About 14,000 EZDRY Food Dehydrators cowl or funnel neckline that can be tight- through Saturday or online at www.cus- have been recalled by Greenfield World ened or loosened by the drawstring tomaticbeds.com and click on Recall Trade Inc., of Fort Lauderdale, Florida. The located at the center front of the neckline. Notice for more information. Photos avail- food dehydrator can overheat, posing fire These sweaters also have a kangaroo-style able at https://www.cpsc.gov/ and burn hazards. This recall involves pocket located at the bottom front of the Recalls/2017/Customatic-Beds-Recalls- white, EZDRY, six-tray food dehydrators. sweater. The zip-up sweater is 97 percent Adjustable-Beds The dehydrator weighs about 4 pounds cotton and 3 percent polyester with a Yar- and measures 12 inches tall by about 8 mouth textured zip-up sweater. It sold in inches deep by 10 inches wide. EZDRY is ivory, ocean surf (green) and lilac ice (lav- Anaheim And Moen Issue Garbage Disposal printed on the front of the dehydrators. ender) colors. The sweater has a hood that Recall EZDRY and the model number EPD60W can be tightened and loosened with a are printed on a white label on the bottom drawstring. The sweater has a silver metal Anaheim and Moen have issued a recall of the unit. They were sold in a white box zipper extending from the neckline to the on their garbage disposals due to an labeled “EZDRY by Excalibur” Home bottom of the sweaters with two pockets impact hazard. “A metal component inside Dehydrator with a picture of the product. on each side of the zipper. The firm has the disposal can break off and come out of These products are marked “Date Code: received one report of a burn injury. the disposal during use, posing an impact 2116, 2416, or 3316” engraved at the The sweaters were sold exclusively at hazard,” states the recall. This recall bottom of the label located on the bottom FatFace stores in Maine, Massachusetts involves 3/4 and 1 horsepower disposals. of the unit. The company has received 13 and Rhode Island and online at www. Recalled brands, model numbers and reports of the dehydrator overheating and fatface.com from September 2016 through serial numbers are listed below. The dis- the plastic unit melting, including six January 2017 for about $60. Consumers posal housings were sold in silver, gray, reports of fire and one report resulting in should immediately stop using the black and blue and have the brand name recalled sweaters and contact the firm for printed on them. The brand name, model

34 BeasleyAllen.com number and serial number are printed on about $100. The Janod Barbecue trolley Fred Meyer Recalls Children’s Hooded a label on the bottom or side of the dispos- sold for about $70. Consumers should Sweatshirts And Girls Bomber Jackets als. About 146,000 (in addition to 2,700 in immediately stop using the recalled trol- Canada) were sold at Best Buy, HD Supply, leys and keep them out of the reach of Fred Meyer, Inc., of Portland, Oregon, Menards, and plumbing supply stores young children until they have installed a has recalled about 48,000 children’s nationwide and online at Amazon.com, repair kit. Contact Juratoys for a free zipper hooded sweatshirts and girls Costco.com, HomeDepot.com, Walmart. repair kit that includes instructions, tools, bomber jackets. The zipper pull can com and other websites from December and footers to prevent the toy from tipping detach from the sweatshirt, posing 2015 through March 2017. There have backwards. Contact: Juratoys toll free at choking and laceration hazards to chil- been 22 reports of a metal component 877-277-1663 from 8:30 a.m. to 5 p.m. ET dren. This recall involves Kids Korner coming out of a disposal, including three Monday through Friday, or online at www. brand fleece hooded sweatshirts and girls reports of a broken component hitting janod.com and click on “Product Recall” bomber jackets with a front zipper, two consumers. There have not been any inju- under the “Janod Express” tab at the top of front pockets, and knit ribbing around the ries reported. For more information the page for more information. Photos wrists and waist. The sweatshirts were contact Anaheim Manufacturing at 800- available at: https://www.cpsc.gov/ sold in 18 different prints and solid colors 628-0797 from 8 a.m. to 5 p.m. ET Monday Recalls/2017/Juratoys-Recalls-Toy-Trolleys in infant, toddler, and children’s sizes 9 through Friday or online at www.ana- months to youth size 7. Kids Korner is heimmfg.com and click on “Product printed on the label at the back of the neck. A white label sewn into the lower Recalls” for more information. Target Recalls Magnetic Tic Tac Toe Games left inside seam has the manufacture date Due To Choking And Magnet Ingestion of “11/16” and style numbers ending in Hazards 8701P, 8701YD, 8671P, 9019, or 9022P. Juratoys Recalls Toy Trolleys Due To These jackets were sold at Fred Meyer, Impact Injury Hazard Target Corp., of Minneapolis, Minne- sota, has recalled about 19,000 Magnetic Kroger, Smith’s and Fry’s Marketplace Juratoys U.S. of Fairfield, New Jersey, tic tac toe games. The magnets can come from February 2017 through March 2017 has recalled about 9,900 Bricolo by Janod® off the tic tac toe game pieces, posing a for between $7 and $10. Consumers Push toy trolleys. The toy trolleys can tip choking hazard. In addition, when two or should immediately stop using the sweat- backwards, posing an impact injury more magnets are swallowed, they can shirt or jacket, and return it to the place of hazard to children. This recall involves link together inside the intestines and purchase for a full refund. Contact Fred four Bricolo by Janod® -push toy trolleys. clamp onto body tissues, causing intesti- Meyer at 800-576-4377 from 8 a.m. to 9 The French Cocotte Cooker trolley is red nal obstructions, perforations, sepsis and p.m. ET Monday through Friday or online with orange wheels and includes a death. Internal injury from magnets can at https://www.fredmeyer.com and click cooktop with fried egg shapes, an oven pose serious lifelong health effects. This on “Recall Alert” located at the bottom of and eight accessories, including pots and recall involves a magnetic tic tac toe 10 x the page for more information. Photos pans “Janod” printed on the side and front 10 inch plywood board with nine “X” and available at https://cpsc.gov/Recalls/2017/ of the trolley and J06544 printed on the “Heart” game pieces. The game pieces Fred-Meyer-Recalls-Childrens-Hooded- base of the toy. The DIY-Magnetic trolley have a magnet on the back. Model number Sweatshirts-and-Girls-Bomber-Jackets is gray and black with red wheels with “234-25-1089” is printed on the bottom work station and tools. “Bricolo” is printed right corner of the product. Target has on the front of the DIY-Magnetic trolley received one report of the magnets falling Frozen Hash Brown Recall Due To Possible and J06505 is printed on the base of the off the game piece. No injuries have ‘Extraneous Golf Ball Materials’ toy. The Redmaster-Magnetic DIY trolley been reported. is black and gray with red wheels and 21 The game was sold exclusively at Target Frozen hash browns sold in nine states accessories, including three magnetic stores nationwide from December 2016 under the Harris Teeter and Roundy’s tools and a set of gears. J06493 is printed through February 2017 for about $5. Con- brands have been recalled. The potatoes on the base of the toy. The Barbecue sumers should immediately stop using the may contain pieces of golf balls, according trolley is brightly colored and comes with recalled tic tac toe game and return it to to the hash brown maker. McCain Foods a magnetic spatula, magnetic barbecue any Target store for a full refund. Contact USA’s recall notice on the US Food & Drug fork, one piece of pork, two sausages, one Target at 800-440-0680 between 7 a.m. to Administration site says the hash browns fish, one piece of beef, and three toma- 8 p.m. CT any day or online at www. could be “contaminated with extraneous toes. J06523 is printed on the base of the target.com and click on “Recalls” at the golf ball materials” that “may have been toy. The trolleys measure approximately bottom of the page, then on “School/Sta- inadvertently harvested with potatoes 17 inches tall and have a 1 foot by 1 foot tionery/Seasonal” or the “Product Recalls” used to make this product.” “Consumption base. Item numbers can be found here: tab on Target’s Facebook page for more of these products may pose a choking https://www.cpsc.gov/Recalls/2017/Jura- information. Photos available at: https:// hazard or other physical injury to the toys-Recalls-Toy-Trolleys . Juratoys has www.cpsc.gov/Recalls/2017/Target- mouth,” says the notice of the voluntary received two reports of trolleys falling Recalls-Magnetic-Tic-Tac-Toe-Games recall. There have been no reported inju- backwards, both resulting in ER visits. ries, according to the company. One involved a tooth extraction the other McCain Foods is recalling 2-pound bags a laceration to the child’s nose. of Roundy’s Brand Frozen Southern Style The toys were sold at various toy stores Hash Browns from Marianos, Metro nationwide including Giggle and Saks Market, and Pick ‘n Save supermarkets in Fifth Avenue, and online at Zulily.com Illinois and Wisconsin. It is also recalling from September 2012 to March 2017 for 2-pound bags of Harris Teeter Brand

JereBeasleyReport.com 35 Frozen Southern Style Hash Browns sold Easter eggs, bunnies, chicks and dinosaurs than 70 reports of skin irritations in North Carolina, South Carolina, Vir- over concerns that, if ingested, the toys and burns. ginia, the District of Columbia, Delaware, can expand inside a child’s body and Florida, Georgia and Maryland. The pro- cause intestinal obstructions. The U.S. duction code on the back of the packaging Consumer Product Safety Commission Uncle John’s Pride Sausage Products is B170119, the company says. The contam- (CPSC) announced the recall, which Recall inated products should be thrown away or involves three toys: Hatch & Grow Easter returned to the place of purchase. Eggs, Easter Grow Toys, and Hatch Your Uncle John’s Pride, LLC., based in Own Dino. Tampa, Florida, has issued a recall for Swallowing the colorful toys could many of its ready-to-eat smoked meat and FDA Issues Recall Of Hyland’s Teething result in “severe discomfort, vomiting, poultry items. These products may be con- Tablets Over ‘Serious Health’ Concerns dehydration and could be life threaten- taminated with extraneous metal materi- ing,” according to the recall notice. als. Approximately 139,909 pounds of the The maker of Hyland’s Baby Teething “Surgery is required to remove the toy smoked meat and poultry sausage prod- Tablets and Hyland’s Baby Nighttime from the body, if ingested.” Further com- ucts were recalled after a metal magnet Teething Tablets is recalling the products plicating matters, the toys “might now was discovered in a beef trim product at the consumer level. A recall on the U.S. show up on an X-ray,” the recall notice used during production. This recall has Food and Drug Administration’s (FDA) warns. The toys should immediately be been classified as a Class I / “High” Health website said the tablets “have been found taken away from children and can be Risk recall, signifying that people may to contain inconsistent amounts of bella- returned to any Target store for a full become dangerously ill or die if they donna alkaloids that may differ from the refund, according to the recall notice. consume these products. The ready-to-eat calculated amount on the products’ Pictures of the hazardous toys on the smoked meat and poultry sausage prod- labels.” Belladonna, a perennial herba- Target Corp. website include the packag- ucts, produced between March 8, 2017 ceous plant, is a “toxic substance,” accord- ing, which states on the front: and April 8, 2017, were distributed to ing to the FDA. “WARNING: CHOKING HAZARD—Small retail stores and foodservices in Alabama, “FDA believes that belladonna repre- parts. Not for children under 3 yrs.” The Florida, and Georgia. They can be identi- sents a serious health hazard to children cautionary advice is adjacent to instruc- fied by the establishment number “EST. and that the effects of belladonna are tions to place the toy in water and “[w] 9179 or P-9179” included inside the USDA unpredictable,” a statement reads. “The atch it grow up to 600 percent it’s original mark of inspection. agency has stated to the company, ‘There size!” No injuries or incidents have been Consumers in possession of the recalled is no known safe dose or toxic dose of bel- reported, but the ingestion hazard is products should not eat them. Rather, they ladonna in children because of the many “serious,” the recall notice states. The are advised to dispose of them or return factors that affect it.’” The recall comes product is manufactured in China, accord- them to their place of purchase just six months after the FDA issued a ing to the Consumer Product Safety Com- for a refund. warning urging consumers to stop using mission (CPSC). homeopathic teething tablets and gels, as The Hatch & Grow Easter Eggs have Once again there have been a large they may pose a risk to infants and model number 234-25-1200 on the back of number of recalls since the last issue. children. the product packaging and contain a While we weren’t able to include all of Hyland’s stopped making the medicines bunny or butterfly inside a toy egg. The them in this issue, we included those of in October 2016. The latest recall covers Easter Grow Toys share the same model the highest importance and urgency. If all Hyland’s products that may have still number and include a chick or bunny. The you need more information on any of the been on store shelves. The tablets were Hatch Your Own Dino Eggs have model recalls listed above, visit our firm’s web used to provide temporary relief of teeth- number 234-09-0016 on the label inserted site at BeasleyAllen.com or RightingInjus- ing symptoms. Children who experience in the packaging and contain toy dino- tice.com. We would also like to know if seizures, difficulty breathing, lethargy, saurs. The small toys were sold at Target we have missed any significant recall that excessive sleepiness, muscle weakness, stores nationwide from February 2017 involves a safety issue. If so, please let us skin flushing, constipation, difficulty uri- through March for about $1. The recall know. As indicated at the outset of this nating, or agitation after using homeo- comes just days before Easter Sunday. The section, you can contact Shanna Malone at pathic teething tablets or gels should seek recall was conducted voluntarily by the [email protected] for medical care immediately. For more infor- company, under the Consumer Product more recall information or to supply us mation, contact the Standard Homeo- Safety Commission’s “Fast Track” recall with information on recalls. pathic Company by calling 800-991-3376 process. “Fast Track recalls are initiated by Monday through Friday. Consumers firms, who commit to work with CPSC to should contact their health care provider quickly announce the recall and remedy XIX. if they believe they have experienced any to protect consumers,” the government problems that may be related to taking or agency states. FIRM ACTIVITIES using this drug product. A spokesperson for Target said the guests can return the item for a full refund without a receipt or proof of purchase. In Firm Growth Provides Unexpected Work- August, the Consumer Product Safety Target Recalls 560,000 Easter Egg Toys Life Balance Opportunity For Beasley Commission worked with McDonald’s Due To Ingestion Hazard Allen’s Dana Taunton Corp. as it recalled 29 million fitness track- Target has recalled approximately ers that were given away in children’s With a newborn and a 3-year-old, 560,000 water-absorbing toys shaped like meals nationwide after receiving more Beasley Allen lawyer Dana Taunton knew

36 BeasleyAllen.com her days of work-related travel needed a combines trail running, trail biking, kaya- • where all government leaders are switch-up. It just so happened that as king, etc. through unmarked wilderness. responsive, inclusive and justice-serv- Dana’s family was growing, Beasley Allen She is married to Derrick Taunton, and ing, and the people are engaged in the was as well, providing her the perfect they have two daughters, Betsie and policy-making process; opportunity to carve a niche for herself at Abigail. To contact Dana, email Dana. the firm and spend more time with her [email protected] or call • where all people live with concern for children. Dana said: 800-898-2034. the common good and respect for the humanity of every person. Through the grace of God, the timing ended up being perfect. It Throughout the legislative session, was becoming more and more diffi- XX. members receive email alerts and follow cult for the attorneys to piece up with phone calls and emails to help together a well-crafted, succinct SPECIAL move legislation along. This past February brief while they were on the road, so RECOGNITIONS more than 160 advocates poured into the this role was developed to meet the State House on Arise’s annual Legislative firm’s needs and my needs. Day to propel interest in the judicial over- ride bill, which eventually passed both Dana now leads the team that handles Alabama ARISE Works For Alabamians houses and became the first bill signed brief writing for Beasley Allen’s Personal into law by Gov. Kay Ivey. Arise Citizens’ Policy Project (ACPP) is Injury and Product Liability Section and is Over the years, Arise has had success in a statewide coalition of 150 congregations the section’s lead appellant attorney. “Any other areas such as welfare reform, public and community groups, as well as individ- complex briefing that needs to be done, education, landlord/tenant rights, health uals, who share the vision of an Alabama we do it—from oppositions to summary care and tax reform. In 2015 it published where all residents have enough food, judgments, defending our experts to the second edition of The Alabama Tax education, health care, and economic complex discovery issues. We run the and Budget Handbook, a comprehensive opportunity to live happy productive whole gamut of brief writing,” she says. but very readable explanation of Ala- lives. Through ACPP and its sister organi- It was unexpected, but turned out to be bama’s state tax structure and budgeting zation, Alabama Arise, members join the perfect fit, which seems to be a theme process that is still available from the together to promote state policies that in Dana’s career. She originally intended Arise office. improve the lives of low-income to become a federal agent after attending My good friend Kimble Forrister heads Alabamians. law school, but found a better fit in prac- up Alabama Arise. He and his excellent More Alabamians need to know about ticing law. staff do very good work. To learn more and support this non-profit organization. Prior to joining Beasley Allen, Dana about Arise and how you can support For nearly 30 years, Alabama Arise has worked for a prominent defense firm and their work through a tax-deductible dona- promoted citizen advocacy on public poli- had a brief stint with the State of Alabama tion, visit www.arisecitizens.org. You can cies affecting low-income Alabamians. Attorney General’s Office. She joined the learn more online at www.arisecitizens. Established in 1988 by 32 religious and firm in 1998 and has handled complex org, on Facebook at www.facebook.com/ community organizations which were business and commercial litigation and alabama.arise or by phone 800-832-9060. concerned about high utility rates, products liability and personal injury liti- Alabama Arise now boasts a membership gation for the firm. of more than 150 such groups as well as A past president of the Alabama State hundreds of individual supporters. Bar Women’s Section, Dana has been XXI. Arise organizers travel all over the state, actively involved with the organization for holding listening sessions to learn about FAVORITE BIBLE years. “It is an important section as, I circumstances that hold low-income believe, women still face unique chal- VERSES people back and to explore how policy lenges,” Dana explained. “The section pro- change can address these barriers to a Billy Irvin, Director of Ministry Rela- motes programs designed to help women better life. Members develop issue propos- tions, Faith Radio 89.1FM, sent in his favor- through these challenges—from balancing als over the summer, then meet in Mont- ite verse for this issue. He says Isaiah 53:5 family and work to providing mentors for gomery each September for a full day of is a verse that means so very much to him young female attorneys just starting prac- spirited discussion before voting to and his entire group. Billy says that is tice. It also highlights women who have choose their legislative agenda for the because Faith Radio is focused on the been trailblazers for other women in the coming year. Arise’s policy team gets busy cross and how our savior died for us. Jesus legal profession.” developing educational materials to help died for us, not because of anything we In addition, Dana is a member of the lawmakers as well as the general public have done, but because He loves Alabama Association for Justice (ALAJ), understand the issues and develop long- us so much. where she serves on the AMICUS Commit- term solutions. Alabama Arise has a vision tee and on the editorial board for ALAJ to make Alabama a place: But he was pierced for our trans- Magazine; American Association for gressions, he was crushed for our Justice; Montgomery County Bar Associa- • where all people have resources and iniquities; the punishment that tion; Montgomery County Association for opportunities to reach their potential to brought us peace was on him, and Justice; Alabama State Bar; and Trial live happy, productive lives, and each by his wounds we are healed. Lawyers for Public Justice. successive generation is ensured a Isaiah 53:5 Dana, who loves “any and all sports,” secure and healthy future; recently began adventure racing, which Stephanie Monplaisir, a lawyer in our firm’s Personal Injury & Products Liability

JereBeasleyReport.com 37 Section, furnished two timely verses for Now the tax collectors and sinners her path to the work being done at Beasley this issue. Stephanie says she grew up were all gathering around to hear Allen. Leigh says: hearing the Easter story, but this year, she Jesus. But the Pharisees and the says she finally “got” what it really means teachers of the law muttered, “This I am thankful that though we have for believers. Before Jesus’s resurrection, man welcomes sinners and eats grown over the years and practice believers lacked two things: direct access with them.” Then Jesus told them around the country, the atmosphere to God and hope in Life after Death. this parable: “Suppose one of you within our firm is still very much Stephanie pointed out that as soon as has a hundred sheep and loses one like a small Alabama firm. The Jesus took his last breath, the veil was torn of them. Doesn’t he leave the ninety- opportunity to help people at a point that divided people from God. When nine in the open country and go of real need, to stand in the gap for Jesus came back on the third day, that was after the lost sheep until he finds it? them, and to fight on their behalf proof that this life is not the end for And when he finds it, he joyfully against true corporate Goliaths is a believers. puts it on his shoulders and goes privilege. home. Then he calls his friends and And when Jesus had cried out again Much of Leigh’s recent work has neighbors together and says, ‘Rejoice involved issues surrounding women’s in a loud voice, he gave up his spirit. with me; I have found my lost sheep.’ At that moment the curtain of the health. Leigh was recently selected to I tell you that in the same way there serve as co-lead counsel for consolidated temple was torn in two from top to will be more rejoicing in heaven bottom. The earth shook, the rocks multidistrict litigation (MDL) in New over one sinner who repents than Jersey federal court concerning talcum split and the tombs broke open. The over ninety-nine righteous persons bodies of many holy people who had powder’s link to ovarian cancer in who do not need to repent. women. Talc, a mineral made up of died were raised to life. They came Luke 15:1-7 out of the tombs after Jesus’ resur- various elements, is ground down to make rection and went into the holy city talcum powder—a cosmetic used to and appeared to many people. absorb moisture and is widely available in Matthew 27: 50-53 various products including baby powder. XXII. Tragically, multiple statistics show that Therefore, if anyone is in Christ, the nearly 14,000 women die from talc-related new creation has come: The old has CLOSING ovarian cancer annually. These lawsuits gone, the new is here! All this is OBSERVATIONS allege Defendant Johnson & Johnson is from God, who reconciled us to liable for personal injuries or wrongful himself through Christ and gave us deaths that resulted from ovarian or the ministry of reconciliation: that Leigh O’Dell “Stands In The Gap” For uterine cancer in women who used the God was reconciling the world to Clients Against Corporate Giants company’s talc products for femi- himself in Christ, not counting peo- nine hygiene. ple’s sins against them. And he has Our firm’s Leading Ladies Series contin- Leigh also handles other female-specific committed to us the message of rec- ues with yet another female Beasley Allen cases involving transvaginal mesh. Trans- onciliation. We are therefore Christ’s lawyer who fights daily for the rights of vaginal mesh is used to repair conditions ambassadors, as though God were her clients and that is Leigh O’Dell. A such as pelvic organ prolapse (POP) and making his appeal through us. We native of Prattville, Alabama, Leigh and stress urinary incontinence (SUI). The implore you on Christ’s behalf: Be her siblings grew up working in her mesh is implanted through the vagina and reconciled to God. God made him father’s small business, handling tasks is used to shore up pelvic organs that have who had no sin to be sin for us, so from loading pallets to bookkeeping. This become displaced due to age, childbirth, that in him we might become the experience helped fuel Leigh’s apprecia- hysterectomy or obesity. Leigh is currently righteousness of God. 2 Corinthi- tion for small businesses, corporate struc- investigating cases linked to mesh manu- ans 5:17-21 tures and tax planning. As a result, Leigh factured by American Medical Systems, graduated from Auburn University with a Bard, Boston Scientific, Caldera and Janet Glaze, an accounting clerk in our degree in Accounting. She then continued Johnson & Johnson. Toxic Torts Section, says selecting favorite onto law school at the University of The U.S. Judicial Panel on Multidistrict verses has always been a hard thing for Alabama with a focus on tax and corpo- litigation (JPML) granted motions to create her to do. She says that’s because as she rate law—all with the goal of assisting her consolidated multidistrict litigations grows in her faith, she finds new ways to father with the family business. (MDLs) against seven mesh manufacturers apply even the smallest of words that are However, Leigh says the Lord had differ- under Chief Judge Joseph R. Goodwin in in the Bible in her life. Janet’s favorite ent plans for her. Her father, Billy O’Dell, the U.S. District Court for the Southern Bible verse since her childhood have been passed away unexpectedly during Leigh’s District of West Virginia. Judge Goodwin Hebrews 13:8. third year of law school. That led to appointed Leigh as a member of the Plain- Jesus Christ is the same yesterday, Leigh’s first exposure to the courtroom tiffs Steering Committee for each of these today and forever. Hebrews 13:8 following her clerkship under Judge Ira MDLs. Leigh is a member of the Alabama DeMent. Through this experience, Leigh State Bar, where she is a member of the Kim Owen, a Legal Assistant in our came to understand the importance of Federal Court Practice Section; Alabama Mass Torts Section, also furnished a verse helping people in need, and though she Association for Justice; Alabama Law for this month, which told the Parable of will always miss her father, she remains Foundation; Montgomery County Trial the Lost Sheep. forever grateful to the Lord for redirecting Lawyers Association; American Bar Asso- ciation; Christian Legal Society and the

38 BeasleyAllen.com Federal Bar Association. Leigh also is a work is the price we must pay for supports 35 of Alabama’s 67 counties and member of the American Association for success. I think you can accomplish an estimated 375,000 Alabamians in need. Justice and serves on the AAJ Transvaginal anything if you’re willing to pay “Our Heart of Alabama network has an Mesh Litigation Group. To contact Leigh, the price. extended reach to more than 800 local email [email protected] or community agencies, but we continue to call 800-898-2034. Vincent Lombardi grow because there are still more neigh- bors we need to be able to help,” said Richard A. Deem, chief executive officer Our Monthly Reminders of the Montgomery Area Food Bank. XXIII. Summer is traditionally a slow time for food donations, Deem explained, though If my people, who are called by my PARTING WORDS the need actually increases when school name, will humble themselves and ends and thousands of children lose access pray and seek my face and turn to meals. from their wicked ways, then will I Lawyers Work To Reduce Hunger Across Only an estimated 10 percent of chil- hear from heaven and will forgive Alabama dren who receive free or reduced-price their sin and will heal their land. lunches during the school year have It’s my firm belief that lawyers have a access to summer meal programs. 2 Chron 7:14 responsibility to be actively involved in Deem said: community affairs. Service to the commu- All that is necessary for the triumph nity is very important. I will mention a During these months, we have an of evil is that good men do nothing. project that is a prime example of such interactive map of the locations of involvement. this year’s Summer Youth Feeding Edmund Burke Approximately 140,000 pounds of programs on our Web site. We have food—the weight of six school buses— several outreach programs designed Woe to those who decree unrigh- was donated to the Alabama Food Bank to target families, seniors and, of teous decrees, Who write misfor- Association as a result of last year’s course, children. In fact, we have a tune, Which they have prescribed. Alabama Legal Food Frenzy. This year, new pilot program called Feeding To rob the needy of justice, And to Beasley Allen and more than 50 other law Our Remarkable Kids (FORK). take what is right from the poor of firms from around Alabama competed FORK supports the adoption of a My people, That widows may be against each other to continue providing local school by one of our agencies, their prey, And that they may rob food for families served by the associa- which in turn provides help to stu- the fatherless. tion’s eight regional food banks. “The food dents and families needing a little and funds raised during this competition more than the school’s breakfast Isaiah 10:1-2 provided the equivalent of almost 120,000 and lunch program can provide. meals over the summer months,” Laura The Legal Food Frenzy provides law I am still determined to be cheerful Lester, executive director of the Alabama firms with not only the opportunity for and happy, in whatever situation I Food Bank Association, said. “It was bragging rights, but more importantly, may be; for I have also learned from incredibly meaningful to see the impact with the chance to provide meals for chil- experience that the greater part of the legal community had on fighting dren who are in need and struggle for our happiness or misery depends hunger in Alabama.” good nutrition. The Legal Food Frenzy was upon our dispositions, and not upon This is the second year the Alabama held April 24-May 5. However, folks can our circumstances. Attorney General’s Office, the Alabama State Bar and the Alabama Food Bank still donate food. Our firm will assist you. Martha Washington (1732 - 1802) Association joined together to help end To donate to Alabama Food Bank Associa- child hunger through the Alabama Legal tion through Beasley Allen, contact Helen Taylor at 800-898-2024 or Helen.Taylor@ The only title in our Democracy Food Frenzy, which runs through May 5. beasleyallen.com. For more information superior to that of President is the During this time, law firms across on helping end childhood hunger in the title of Citizen. Alabama, competing in size-based catego- ries, collected food from employees and River Region, visit montgomeryarea- Louis Brandeis, 1937 their communities to be distributed by foodbank.org. U.S. Supreme Court Justice their local food banks. Food collected God has blessed our law firm and we from firms in the River Region will help consider it our responsibility to bless others. In fact, we at Beasley Allen con- The dictionary is the only place that the Montgomery Area Food Bank, which sider it our obligation to do so. success comes before work. Hard

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Jere L. Beasley, Principal & Founder of the law firm Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. is one of the most successful litigators of all time, with the best track record of verdicts of any lawyer in America. Beasley’s law firm, established in 1979 with the mission of “helping those who need it most,” now employs over 75 lawyers and more than 175 support staff. Jere Beasley has always been an advocate for victims of wrongdoing and has been helping those who need it most for over 35 years. Jere Locke Beasley , founding shareholder of the law firm Beasley, Allen, Crow, Methvin, Portis & Miles, P.C., is one of the most successful litigators of all time, with the best track record of verdicts of any lawyer in America. Beasley’s law firm, established in 1979 with the mission of “helping those who need it most,” now

employs 44 lawyersNo representation and more is made than that the 200 quality support of services staff. to Jere Beasley has always been an advocatebe performed for victims is greater of than wrongdoing the quality of legal and services has been helping those who need it most for over 30performed years. by other lawyers.

No representation is made that the quality of services to be performed is greater than the quality of legal services performed by other lawyers.