Page 1 of 57 East Baton Rouge Parish Clerk of Court

THE PARISH OF EAST BATON ROUGE 19TH JUDICIAL DISTRICT COURT FOR STATE OF LOUISIANA ) 5 DIVI NUMBER: THROUGH THE SECRETARY OF THE LOUISIANA DEPARTMENT OF HEALTH, LOUISIANA DEPARTMENT OF HEALTH STATE

VERSUS SEP 2D(2017

INC.; THE PURDUE FREDERI PUTY CLE OF COURTs PURDUE PHARMA L.P.; PURDUE PHARMA, INDUSTRIES, LTD.; TEVA COMPANY, INC.; TEVA PHARMACEUTICAL INC.; JOHNSON & JOHNSON; PHARMACEUTICALS USA, INC.; CEPHALON, PHARMACEUTICALS, INC.; ORTHO-MCNEIL-JANSSEN JANSSEN INC.; ENDO INC. n/k/a JANSSEN PHARMACEUTICALS, PHARMACEUTICALS, INC.; ALLEGRAN PLC SOLUTIONS INC.; ENDO PHARMACEUTICALS, HEALTH INC. n/k/a ACTAVIS, INC.; f/k/a ACTAVIS PLC; WATSON PHARMACEUTICALS, LLC; ACTAVIS PHARMA, INC. f/k/a WATSON LABORATORIES, INC.; ACTAVIS WATSON PHARMA, INC.

****************************************************************************** RELIEF PETITION FOR DAMAGES AND INJUNCTIVE the Secretary of the Louisiana Plaintiff, the Louisiana Department of Health, through and Injunctive Relief against Defendants Department of Health, files this Petition for Damages

named herein as follows:

I. INTRODUCTION/BACKGROUND

1.

the Secretary of the Louisiana Plaintiff, the Louisiana Department of Health, through

Department of Health, alleges the following: 2.

to flood Louisiana with highly- Drug manufacturers undertook an orchestrated campaign relievers" or "opioids") in an effort to addictive and dangerous opioids ("opioid analgesic pain their customers including the healthcare maximize profits above the health and well-being of drug manufacturers knew prescribing systems supporting those customers. Importantly, these and representations from these doctors and other health-care providers relied upon statements Instead of providing truthful same drug manufacturers in determining treatment decisions. opioid analgesic pain relievers they representations regarding the dangerous and addictive statements unsupported by produce, these same drug manufacturers provided false and misleading and widespread use of their science and medical evidence in an effort to promote the purchase

dangerous and addictive narcotics.

#8.1 Page 2 of 57 East Baton Rouge Parish Clerk of Court

3. pain representations concerning opioid analgesic As a result of these false and misleading health, a healthcare crisis that has had far-reaching relievers, these drug manufacturers caused States. On in Louisiana and throughout the United financial, social, and deadly consequences Opioid Crisis Combating Drug Addiction and the July 31, 2017, the Commission on to the President of the United States that ("Commission") issued an interim report recommending emergency.' In that interim report, the Commission he declare the opioid epidemic a national 1999, the Notably, the Commission explained: "Since grimly declared: "Our nation is in crisis."2 Not have quadrupled according to the CDC. number of opioid overdoses in America of prescription opioids in America have coincidentally, in that same period, the amount

quadrupled as well."3 4.

prescription opioid analgesic pain relievers Defendants manufacture, market, and sell HP, Butrans, Hysingla ER, and Targiniq including OxyContin, MS Contin, Dilaudid/Dilaudid Opana/Opana ER, Percodan, Zydone, Kadian, ER, Percocet, Actiq, Fentora, Duragesic, analgesic pain relievers were considered oxycodone, hydrodone and Norco. Historically, opioid chronic pain (e.g., back pain, migraines, and too addictive and debilitating for the treatment of used only to treat short-term acute pain or arthritis). Instead, opioid analgesic pain relievers were

for hospice (or palliative/end-of-life) care. 5.

Defendant instituted a marketing However, by the late 1990s, and continuing today, each opioid analgesic pain relievers should be scheme designed to persuade doctors and patients that patients much more likely to become used for chronic pain, creating a far broader group of use of opioid analgesic pain addicted and suffer other adverse effects from the long-term spent, and continues to spend, millions relievers. In connection with this scheme, each Defendant deny or trivialize the risks of opioid of dollars on promotional activities and materials that falsely of using them for chronic pain. As to the analgesic pain relievers while overstating the benefits to the language of their drugs' labels: (1) risks, Defendants falsely and misleadingly, and contrary the concept of "pseudo-addiction" and downplayed the serious risk of addiction; (2) promoted

https://www.whitehouselovisites/whitehouse.gov/filesiondcp/commission-interim-report.pdf.

2 Id. at p. 1.

Id. (emphasis added).

#8.2 Page 3 of 57 East Baton Rouge Parish Clerk of Court

analgesic pain should be treated with more opioid thus advocated that the signs of addiction (4) claimed of screening tools in preventing addiction; relievers; (3) exaggerated the effectiveness of higher opioid are easily managed; (5) denied the risks that opioid dependence and withdrawal to prevent of "abuse-deterrent" opioid formulations dosages; and (6) exaggerated the effectiveness use of also falsely touted the benefits of long-term abuse and addiction. Conversely, Defendants pain relievers the supposed ability of opioid analgesic opioid analgesic pain relievers, including to support even though there was no "good evidence" to improve function and quality of life,

Defendants' claims. 6.

messages to reverse the accepted medical Defendants disseminated these common messages relievers. Defendants disseminated these understanding of opioid analgesic pain that and in speaker groups led by physicians directly, through their sales representatives, also Defendants' marketing messages. Defendants Defendants recruited for their support of and by: (a) funding, assisting, encouraging, worked through third parties they controlled leaders" ("KOLs") and (b) funding, assisting, directing doctors, known as "key opinion credible professional societies and patient directing, and encouraging seemingly neutral and Groups"). Defendants then worked together advocacy groups (referred to hereinafter as "Front that doctors and patients relied on for with those KOLs and Front Groups to taint the sources guidelines, Continuing Medical Education ostensibly "neutral" guidance, such as treatment and scientific articles. Thus, working ("CME") programs, medical conferences and seminars, Groups and KOLs, Defendants persuaded individually and collectively, and through these Front that opioid analgesic pain relievers are doctors and patients that what they had long known, long-term use, was untrue. In fact, addictive drugs, unsafe in most circumstances for that the compassionate treatment Defendants used their marketing scheme to falsely represent pain relievers. of pain actually required widespread use of opioid analgesic 7.

the risks and benefits of opioid Each Defendant knew that its misrepresentations of contrary to scientific evidence.4 analgesic pain relievers were not supported by or were directly

CDC Pain, issued in 2016 and approved by the FDA ("2016 4 Guideline for Prescribing Opioids for Chronic Guideline"), available athttps://www.cdc.gov/mmwr/volumes/65/rr/rr6501eI.htm.

#8.3 Page 4 of 57 East Baton Rouge Parish Clerk of Court

8. enterprise (or also formed an opioid marketing As more fully detailed below, Defendants pain relievers for the widespread use of opioid analgesic "Cartel") for the purpose of promoting

chronic pain. 9. of its continue to promote) the purchase and use Defendants successfully promoted (and statements products through dissemination of false dangerous and highly-addictive opioid a result, with continued use of these products. As despite knowledge of the danger associated United most prescribed class of drugs in the opioid analgesic pain relievers are now the approximately $11 billion in revenue for drug States.5 Annually, opioid sales generate more in August 2016, the then-United States companies. In an open letter to the nation's physicians health crisis" to "heavy marketing of opioids Surgeon General expressly connected this "urgent — incorrectly — that opioids are not addictive to doctors . . . [m]any of [whom] were even taught resulted in a flood of prescription opioids when prescribed for prescribed by doctors, has supply"), and a population of patients available for illicit use or sale (referred to as "the to as "the demand").6 And when physically and psychologically dependent on them (referred opioids, they often turn to the illegal those patients can no longer afford or legitimately obtain opioid analgesic pain relievers or and secondary black market in order to purchase prescription The original market for opioid even heroin (referred to herein as "the secondary market"). the United States. According to analgesic pain relievers "primes" the heroin market throughout by the Substance Abuse and the July 31, 2017, Commission interim report (citing reports Health and Statistics Quality), Mental Health Services Administration Center for Behavioral after first using prescription "[flour out of every five new heroin users" start using heroin

opioids.7 10.

for opioid As more fully detailed below, annually, there were more prescriptions of Defendants' actions, analgesic pain relievers than actual Louisiana residents. Because in a public health crisis. Louisiana is overrun with opioid analgesic pain relievers and engulfed

drug use. (2014). httnJ/www.cdc.gov/nchs/fastats/drug-use- 5 Centers for Disease Control and Prevention. FastStats. Therapeutic therapeutic.htm. August 2016, available at http://turnthetiderx.org/. 6 Vivek H. Murthy, Letter from the Surgeon General,

7 https://www.whitehouse.govisites/whitehouse.govffiles/ondcp/commission-interim-report.pdf.

#8.4 Page 5 of 57 East Baton Rouge Parish Clerk of Court

11. the opioid crisis. to suffer catastrophic damages from Louisiana has suffered and continues opioid analgesic and disseminated by Defendants, Contrary to the false propaganda published The supernatural crisis both nationally and in Louisiana. pain relievers represent a health and (opioid analgesic pain relievers or "opioids") addictive qualities of Defendants' products analgesic pain available data. For instance, opioid resulting impact are easily confirmed by and use written per year.8 As opioid dispensation relievers represent 289 million prescriptions than department visits which increased by more increased, so did the number of emergency the dramatic increase in emergency department 200 percent from 2005 to 20119 Along with pain relievers reached epic proportions in visits, overdose deaths caused by opioid analgesic as result of prescription drugs.1° In addition 2014 when 25,760 people died in the United States created by the addiction to opioid analgesic to these direct deaths, the secondary heroin market the number of heroin overdose deaths from pain relievers resulted in an increase of five times that time period, Defendants' drugs 1 878 deaths in 2004 to 10,574 deaths in 2014.11 During and "O.C." (OxyContin, Percodan, and earned poignant street names such as: "Hillbilly Heroin" 8," "China White," "Goodfella," and Percocet); "0 Bomb" and "Stop Signs" (Opana); "Murder

"TNT" (Actiq and Duragesic).12 12.

2016, opioids As detailed by the United States Surgeon General in November detrimental use:13 manufactured by the Defendants virtually guarantee their continued to a release of Opioids attach to opioid receptors in the brain, which leads drowsiness, dopamine in the nucleus accumbens, causing euphoria ("the high"), is why they are and slowed breathing, as well as reduced pain signaling (which involves a frequently prescribed as pain relievers). Opioid addiction typically (3) pattern of: (1) intense intoxication, (2) the development of tolerance, negative escalation in use, and (4) withdrawal signs that include profound

(2015). Trends in opioid analgesic-prescribing rates by 8 Levy, B., Paulozzi, L. Mack, K.A., & Jones, C.M. 409-413. specialty, US, 2007-2012. American Journal of Preventative Medicine, 49(3), department visits involving narcotic pain relievers. 9 Crane, E. H. (2013). The CBHSQ Report: Emergency Center for Behavioral Health Rockville, MD: Substance Abuse and Mental Health Services Administration, Statistics and Quality. Multiple cause of death 1999 — 2014. I° Centers for Disease Control and Prevention. (2016). CDC Wonder: Retrieved from httos:/lwonder.cdc.gov/wonder/help/mcd.html. in drug and opioid overdose deaths — 11 Rudd, R. A., Aleshire, N., Zibbel, J. E., & Gladden, R. M. (2016). Increases United States, 2000-2014. MMWR, 64(50), 1378-1382.

12 NIDA (2016) & DEA (2015).

(HITS), Office of the Surgeon General, Facing Addiction in 13 U.S. Department of Health and Human Services Washington, DC: HHS, November 2016. America: The Surgeon General's Report on Alcohol, Drugs, and Health. (Emphasis added).

#8.5 Page 6 of 57 East Baton Rouge Parish Clerk of Court

discomfort, pain, sweating, and physical symptoms, such as bodily emotions and use progresses, the the most severe cases, seizures. As intestinal distress and, in during the severe negative effects that occur opioid must be taken to avoid the to opioids, stimuli associated with withdrawal. With repeated exposure (e.g., places, persons, moods, and paraphernalia) pleasant effects of the substances trigger physical effects of withdrawal can and with the negative mental and use. intense craving or preoccupation with opioid use, and destruction inherent in continued Instead of honestly conveying the power to maximize lethal nature of their products in order Defendants masked the devastating and

profits. 13.

Centers for Disease Control and Prevention According to statistics published by both the Preventing Opioid Abuse, annually, there are 122 ("CDC") and the Louisiana Commission on (i.e. there are more opioid prescriptions than opioid prescriptions for every 100 Louisianans ranked 7th in 2013, 8th in 2014 8th in Louisiana residents). According to the CDC, Louisiana rate of opioids. Over the last six years, 2015, and 5th in 2016 in the United States for prescription in prescription rates for opioids. Louisiana averaged 39% higher than the national average resulting from opioid use in 2014 Corrected data concerning overdose deaths in Louisiana t4 evidenced a 125% increase from that originally published. 14.

that opioid abuse costs A report authored by Matrix Global Advisors, LLC estimated alone.I5 Additional costs and Louisianans $296 million dollars per year in healthcare costs and corrections strains on the criminal justice system to include increased costs of enforcement costs will continue to are astronomical and have negatively impacted Louisiana. Unabated, these

increase as the epidemic continues to spread. 15.

of Health As a result of the manmade opioid epidemic, the Louisiana Department Just for the costs of ("LDH") has incurred devastating costs (damages) to its Medicaid Program. (not the amounts medications designed and prescribed to treat opioid overdoses and dependence made payments of paid for the opioids themselves), the Louisiana Department of Health in 2015, $7,826,169.48 in 2012, $8,289,855.38 in 2013, $7,825,960.51 in 2014 $9,158,782.13

Geographic Variation in Opioid and Heroin 14 Ruhm, C.J. (2017) American Journal of Preventive Medicine, Involved Drug Poisoning Mortality Rates. Retrieved from: http://dx.doi.org/10.1016/j.amepre.2017.06.009. from Opioid Abuse: A State by State Analysis. Retrieved 15 Matrix Global Advisors, LLC (2014) Health Care Costs 040415.pdf. from: httos://drugfree.org/wp-content/uploads/2015/Matrix Opioidabuse

#8.6 Page 7 of 57 East Baton Rouge Parish Clerk of Court

made Medicaid the Louisiana Department of Health and $12,735,803.42 in 20106 Thus, for some treatment dollars over a five-year span just to pay payments totaling almost 46 million over this time above, these Medicaid payments increased costs of opioid dependence. As shown of the manmade to do so given the unhindered spread span and will, undoubtedly, continue

opioid epidemic. 16.

of Health incurred approximate costs From 2007 to present, the Louisiana Department of use and dependence. The Louisiana Department totaling $677,254,416 for treatment of opioid its Behavioral Health component. Health incurred additional significant costs under 17.

caused to be submitted approximately From 2007 to present, collectively, the Defendants Department of Health, on behalf of 2,168,427 prescriptions for reimbursement to the Louisiana turn, the Louisiana Department of Health, on the Louisiana Medicaid system, for their opioids. In for these drugs. Notably, these behalf of the Louisiana Medicaid system, paid $83,255,635.44 the following: submissions and payments included but were not limited to Inc., and The the Purdue Defendants (Purdue Pharma L.P., Purdue Pharma, a. 12,008 Purdue Frederick Company, Inc.) caused to be submitted approximately Health, on behalf prescriptions for reimbursement to the Louisiana Department of opioids. In turn, of the Louisiana Medicaid system, for the Purdue Defendants' Medicaid system, the Louisiana Department of Health, on behalf of the Louisiana paid approximately $28,296,017.12 for these drugs; PLC, Watson b. the Actavis Defendants (Allegran PLC f/k/a Actavis Actavis LLC, Pharmaceuticals, Inc. n/k/a Actavis, Inc., Watson Laboratories, Inc., submitted and Actavis Pharma, Inc. f/k/a Watson Pharma, Inc.) caused to be Louisiana approximately 2,086,429 prescriptions for reimbursement to the for the Department of Health, on behalf of the Louisiana Medicaid system, on Actavis Defendants' opioids. In turn, the Louisiana Department of Health, for behalf of the Louisiana Medicaid system, paid approximately $42,128,485.80 these drugs; LTD, c. the Cephalon Defendants (Cephalon, Inc., Teva Pharmaceutical Industries, and Teva Pharmaceuticals USA, Inc.) caused to be submitted approximately on 7,744 prescriptions for reimbursement to the Louisiana Department of Health, behalf of the Louisiana Medicaid system, for the Cephalon Defendants' opioids. In turn, the Louisiana Department of Health, on behalf of the Louisiana Medicaid system, paid approximately $5,028,975.91 for these drugs;

d. the Janssen Defendants (Janssen Pharmaceuticals, Inc., Ortho-McNeil-Janssen & Pharmaceuticals, Inc. n/k/a Janssen Pharmaceuticals, Inc., and Johnson for Johnson) caused to be submitted approximately 12,008 prescriptions reimbursement to the Louisiana Department of Health, on behalf of the Louisiana Medicaid system, for the Janssen Defendants' opioids. In turn, the Louisiana Department of Health, on behalf of the Louisiana Medicaid system, paid approximately $4,566,342.42 for these drugs; and

and encounters and do not include scenarios where, a 16 These figures are limited to outpatient pharmacy claims office. physician provides treatment for opioid overdose or dependence in a physician's

#8.7 Page 8 of 57 East Baton Rouge Parish Clerk of Court

Pharmaceuticals, Health Solutions Inc. and Endo e. the Endo Defendants (Endo for approximately 11,072 prescriptions Inc.) Caused to be submitted of Health, on behalf of the Louisiana reimbursement to the Louisiana Department opioids. In turn, the Louisiana Medicaid system, for the Endo Defendants' the Louisiana Medicaid system, paid Department of Health, on behalf of drugs. approximately $5,061,604.54 for these 18. amounts the of law, Plaintiff seeks damages for the To redress and punish these violations of those prescriptions and treatments costs as a result LDH has already paid for excessive opioid detailed below. costs) as well as other costs more fully prescriptions (e.g., addiction treatment seeks from their unlawful conduct. LDH also LDH also seeks an order enjoining Defendants granting any attorneys' fees and costs, in addition to punitive damages, treble damages, and as more fully detailed below. other equitable relief authorized by law and II. PARTIES

Plaintiff 19.

of Health, through the Secretary of the This is a civil action by the Louisiana Department

Louisiana Department of Health.

Defendants 20.

organized under the laws of Delaware. PURDUE PHARMA L.P. is a limited partnership with its principal place of business in PURDUE PHARMA INC. is a New York corporation COMPANY is a Delaware Stamford, Connecticut, and THE PURDUE FREDERICK in Stamford, Connecticut (collectively, corporation with its principal place of business

"Purdue"). 21.

opioids such as OxyContin, MS Purdue manufactures, promotes, sells, and distributes Targiniq ER in the United States and Contin, Dilaudid/Dilaudid HP, Butrans, Hysingla ER, and Since 2009, Purdue's annual sales of Louisiana. OxyContin is Purdue's best-selling opioid. $2.99 billion, up four-fold from its 2006 OxyContin have fluctuated between $2.47 billion and 30% of the entire market for analgesic sales of $800 million. OxyContin constitutes roughly to felony misbranding OxyContin with drugs (i.e. painkillers). In May 2007, Purdue pled guilty

#8.8 Page 9 of 57 East Baton Rouge Parish Clerk of Court

Code, Sections 331(a) and violation of Title 21, United States the intent to defraud or mislead in

333(a)(2),I7 22. in with its principal place of business CEPHALON, INC. is a Delaware corporation INDUSTRIES, LTD. ("Teva Ltd.") is an Frazer, Pennsylvania. TEVA PHARMACEUTICAL 2011, Teva Ltd. of business in Petah Tikva, Israel. In Israeli corporation with its principal place USA, INC. ("Teva USA") is a wholly- acquired Cephalon, Inc. TEVA PHARMACEUTICALS corporation with its principal place of business owned subsidiary of Teva Ltd. and is a Delaware in October 2011. in Pennsylvania. Teva USA acquired Cephalon 23.

and distributes opioids such as Actiq and Cephalon, Inc. manufactures, promotes, sells, have been approved by the FDA only for Fentora in the U.S. and Louisiana. Actiq and Fentora in patients 16 years of age and older who are the "management of breakthrough cancer pain therapy for their underlying persistent cancer already receiving and who are tolerant to opioid a criminal violation charging it with the pain." In October 2008, Cephalon pled guilty to were misbranded through off-label introduction into interstate commerce of drugs that 333(a)(1) and 352(f)(1) for its promotion, in violation of Title 21, United States Code, Sections is misleading promotion of Actiq and two other drugs. 24.

closely to market and sell Teva Ltd., Teva USA, and Cephalon, Inc. work together sales and marketing activities for Cephalon products in the United States. Teva Ltd. conducts all done so since its October 2011 Cephalon in the United States through Teva USA and has and Fentora as Teva products to acquisition of Cephalon. Teva Ltd. and Teva USA hold out Actiq products through its "specialty the public. Teva USA sells all former Cephalon branded and medication guide, which is medicines" division. The FDA-approved prescribing information discloses that the guide was distributed with Cephalon opioids marketed and sold in Louisiana, USA to report adverse events. All submitted by Teva USA, and directs physicians to contact Teva prominently display of Cephalon's promotional websites, including those for Actiq and Fentora, Teva USA's sales as its own, Teva Ltd.'s logo. Teva Ltd.'s financial reports list Cephalon's and the Cephalon acquisition — and its year-end report for 2012 — the year immediately following

Inc., (1:07-cr-00029-JPJ) (W.D. Va.). 17 United States v. The Purdue Frederick Company, Pa.). 18 United States v. Cephalon, Inc., (08-cr-00598) (ED.

#8.9 10 of 57 East Baton Rouge Parish Clerk of Court Page

year of medicine sales to "the inclusion of a full attributed a 22% increase in its specialty operations like these, Teva Ltd. operates in Cephalon's specialty sales." Through interrelated USA. The through its subsidiaries Cephalon and Teva Louisiana and the rest of the United States markets, representing 53% of its global revenue United States is the largest of Teva Ltd.' s global would of Teva USA and Cephalon, Inc., Teva Ltd. in 2015, and, were it not for the existence States itself. Upon information and belief, Teva conduct those companies' business in the United the and Teva USA, and their profits inure to Ltd. directs the business practices of Cephalon (Teva Pharmaceutical Industries, Ltd., Teva benefit of Teva Ltd. as controlling shareholder. are referred to as "Cephalon."). Pharmaceuticals USA, Inc., and Cephalon, Inc. 25.

Pennsylvania corporation with its principal JANSSEN PHARMACEUTICALS, INC. is a is a wholly owned subsidiary of JOHNSON & place of business in Titusville, New Jersey, and its principal place of business in New JOHNSON ("J&J"), a New Jersey corporation with PHARMACEUTICALS, INC., now Brunswick, New Jersey. ORTHO-MCNEIL-JANSSEN is a Pennsylvania corporation with its known as JANSSEN PHARMACEUTICALS, INC., PHARMACEUTICA INC., now principal place of business in Titusville, New Jersey. JANSSEN a Pennsylvania corporation with its known as JANSSEN PHARMACEUTICALS, INC., is is the only company that owns more principal place of business in Titusville, New Jersey. J&J with the FDA regarding Janssen's than 10% of Janssen Pharmaceuticals' stock, and corresponds sale and development of Janssen products. Upon information and belief, J&J controls the (Janssen Pharmaceuticals, Pharmaceuticals' drugs and Janssen's profits inure to J&J's benefit Inc., and J&J are Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc., Janssen Pharmaceutical,

referred to as "Janssen."). 26.

and the United Janssen manufactures, promotes, sells, and distributes drugs in Louisiana for at least $1 billion States, including the opioid Duragesic. Before 2009, Duragesic accounted sold the opioids Nucynta in annual sales. Until January 2015, Janssen developed, marketed, and $172 million in sales in and Nucynta ER. Together, Nucynta and Nucynta ER accounted for

2014.

#8.10 East Baton Rouge Parish Clerk of Court Page 11 of 57

27.

corporation with its principal place ENDO HEALTH SOLUTIONS INC. is a Delaware PHARMACEUTICALS INC. is a wholly-owned of business in Malvern, Pennsylvania. ENDO Delaware corporation with its principal place subsidiary of Endo Health Solutions Inc. and is a Solutions Inc. and Endo Pharmaceuticals of business in Malvem, Pennsylvania (Endo Health

Inc. are referred to as "Endo"). 28.

the opioids Opana/Opana Endo develops, markets, and sells prescription drugs, including United States. Opioids made up ER, Percodan, Percocet, and Zydone, in Louisiana and the Opana ER yielded $1.15 roughly $403 million of Endo's overall revenues of $3 billion in 2012. Endo's total revenue in billion in revenue from 2010 and 2013, and it accounted for 10% of oxymorphone, 2012. Endo also manufactures and sells generic opioids such as oxycodone, by itself and hydromorphone, and hydrocodone products in Louisiana and the United States,

through its subsidiary, Qualitest Pharmaceuticals, Inc.

29.

ALLERGAN PLC is a public limited company incorporated in Ireland with its principal

place of business in Dublin, Ireland. ACTAVIS PLC acquired Allergan plc in March 2015, and

the combined company changed its name to Allergan plc in January 2013. Previous to that

transaction, WATSON PHARMACEUTICALS, INC. acquired ACTAVIS, INC. in October

2012, and the combined company changed its name to Actavis, Inc. as of January 2013 and then

Actavis plc in October 2013. WATSON LABORATORIES, INC. is a Nevada corporation with

its principal place of business in Corona, California, and is a wholly-owned subsidiary of

Allergan plc (f/k/a Actavis, Inc., f/k/a Watson Pharmaceuticals, Inc.). ACTAVIS PHARMA,

INC. (f/k/a Actavis, Inc.) is a Delaware corporation with its principal place of business in New

Jersey and was formerly known as WATSON PHARMA, INC. ACTAVIS LLC is a Delaware

limited liability company with its principal place of business in Parsippany, New Jersey. Each

of these defendants is owned by Allergan plc, which uses them to market and sell its drugs in

the United States. Upon information and belief, Allergan plc exercises control over these

marketing and sales efforts and profits from the sale of Allergan/Actavis products ultimately

inure to its benefit (Allergan plc, Actavis plc, Actavis, Inc., Actavis LLC, Actavis Pharma, Inc.,

#8.11 Page 12 of 57 East Baton Rouge Parish Clerk of Court

referred Inc., and Watson Laboratories, Inc. are Watson Pharmaceuticals, Inc., Watson Pharma,

to as "Actavis."). 30.

distributes opioids, including the branded Actavis manufactures, promotes, sells, and and of Kadian, and generic versions of Duragesic drugs Kadian and Norco, a generic version Actavis acquired the rights to Kadian from King Opana, in Louisiana and the United States. marketing Kadian in 2009, Pharmaceuticals, Inc. on December 30, 2008, and began

III. JURISDICTION AND VENUE

31.

Health, through the Secretary of the This is an action by the Louisiana Department of of Health, through the Secretary of Louisiana Department of Health. The Louisiana Department on the distinct harm suffered by the the Louisiana Department of Health, brings this action based of state law and legal duties Louisiana Department of Health caused by Defendants' violations

owed. 32.

business in This Court has personal jurisdiction over Defendants as they conduct and/or have the Louisiana, purposefully direct or directed their actions toward Louisiana, permit the Court to requisite minimum contacts with Louisiana necessary to constitutionally alleges that the exercise jurisdiction. Furthermore, the Louisiana Department of Health Parish in the State Defendants' unlawful conduct occurred, at least in part, in East Baton Rouge and venue is of Louisiana. As such, this Court has personal jurisdiction against Defendants

proper in this Parish pursuant to LSA-R.S. 13:3201.

IV. FACTUAL ALLEGATIONS

33.

Before the 1990's, generally accepted standards of medical practice dictated that opioid to recovery analgesic pain relievers should only be used short-term for acute pain, pain relating lack of from surgery, or for cancer or palliative ("hospice" or "end-of-life") care. Due to the pain and evidence that opioid analgesic pain relievers improved patients' ability to overcome to function, coupled with evidence of greater pain complaints as patients developed tolerance effects, opioid analgesic pain relievers over time and the serious risk of addiction and other side

#8.12 Page 13 of 57 East Baton Rouge Parish Clerk of Court

or prohibited. As a relievers for chronic pain was discouraged the use of opioid analgesic pain opioids for chronic pain. result, doctors generally did not prescribe 34. state market for chronic pain patients and To take advantage of the lucrative scheme Defendants developed a well-funded marketing reimbursements for prescription drugs, and practices. Defendants used both direct marketing employing deceptive representations and independent third parties to spread false and unbranded advertising disseminated by seemingly that benefits of long-term opioid use — statements deceptive statements about the risks and -parties who gained legitimacy when Defendants benefited not only themselves and the third and opioid manufacturers. However, these repeated those statements, but also other Defendants to the scientific evidence, these statements statements were not only unsupported by or contrary from the United States Food and Drug were also contrary to pronouncements by and guidance and Prevention. In addition, Defendants Administration and the Centers for Disease Control populations. targeted susceptible prescribers and vulnerable patient 35.

marketing their branded opioid Defendants spread their false and deceptive statements by Defendants also deployed analgesic pain relievers directly to doctors and patients in Louisiana. to spread their false and seemingly unbiased and independent third parties that they controlled analgesic pain relievers for the deceptive statements about the risks and benefits of opioid

treatment of chronic pain throughout Louisiana. 36.

proceeded on Defendants' direct marketing of opioid analgesic pain relievers generally advertising campaigns two tracks. First, each Defendant conducted and continues to conduct spent more than touting the purported benefits of their branded drugs. For example, Defendants triple what they $14 million on medical Journal advertising of opioids in 2011 alone, nearly by Janssen, and gi spent in 2001. This amount included $8.3 million by Purdue, $4.9 million

million by Endo.

37.

the benefits of A number of Defendants' branded advertisements deceptively portrayed on its website opioids for chronic pain. For example, Endo distributed and made available with physically opana.com a pamphlet promoting Opana ER with photographs depicting patients

#8.13 Page 14 of 57 East Baton Rouge Parish Clerk of Court

that the drug would worker and chef, misleadingly implying demanding jobs like construction Purdue ran a series of functional improvement. In 2012, provide long-term pain-relief and These advertisements OxyContin called "Pain vignettes." advertisements in medical journals for patient. One advertisement recommended OxyContin for each featured chronic pain patients and that OxyContin osteoarthritis of the hands" and implied described a "54-year-old writer with Endo and Purdue agreed to effectively. In late 2015 and 2016, would help the writer work more in the State of New York. halt these misleading representations 38. "detailers" use of opioids for chronic pain through Second, each Defendant promoted the and small- doctors and medical staff in their offices) (sales representatives who visited individual each not corrected this misinformation. Instead, group speaker programs. Defendants have with massive resources to direct sales contacts Defendant devoted and continues to devote million on detailing branded opioids to doctors. doctors. In 2014 alone, Defendants spent $168 spent on detailing in 2000. The amount includes This amount is twice as much as Defendants by Janssen, $13 million by Cephalon, $10 million $108 million spent by Purdue, $34 million

by Endo, and $2 million by Actavis. 39.

their deceptive promotions. A July 2010 Defendants' detailers have been reprimanded for Actavis to acknowledge to the doctors to "Dear Doctor" letter mandated by the FDA required 2009 and February 2010, Actavis sales whom it marketed its drugs that "Netween June that . . . omitted and minimized serious representatives distributed . . . promotional materials of linlisuse, [a]buse, and [d]iversion of risks associated with [Kadian]," including the risk the potential for being abused and are [o]pioids" and, specifically, the risk that "[o]pioid[s] have disorders and are subject to criminal sought by drug abusers and people with addiction

diversion." 40.

on their speakers' bureaus and to Defendants also identified doctors to serve, for payment, These speaker programs attend programs with speakers and meals paid for by Defendants. opioid analgesic pain reliever (so provided: (1) an incentive for doctors to prescribe a particular and compensation for the doctors they might be selected to promote the drug); (2) recognition drug through the speaker to his or her selected as speakers; and (3) an opportunity to promote the

#8.14 Page 15 of 57 East Baton Rouge Parish Clerk of Court

providing unbiased and medically false impression that they are peers. These speakers give the prepared by Defendants. are, in fact, presenting a script accurate presentations when they information, omitted these presentations conveyed misleading Upon information and belief, about the risks correct Defendants' prior misrepresentations material information, and failed to relievers. and benefits of opioid analgesic pain 41. which is a one- commonly referred to as "detailing," Defendants also employed a strategy products in hopes "educate" a physician about a vendor's on-one marketing technique used to to products more often. Defendants' detailing that the physician will prescribe the company's prescribing habits, studies indicate that marketing impacts doctors was and is effective. Numerous Defendants greatest influence. Even without such studies, with face-to-face detailing having the industry, the most sophisticated data available in any purchase, manipulate, and analyze some of and Inc., to track the rates of initial prescribing data available from IMS Health Holdings, impact allows them to target, tailor, and monitor the renewal by individual doctor, which in turn their detailing to doctors is effective. of their core messages. Thus, Defendants know 42.

the same marketing plans and Upon information and belief, Defendants employed in Louisiana as they did nationwide. Across the strategies and deployed the same messages is funded and overseen on a national basis pharmaceutical industry, "core message" development ensures that Defendants' messages are by corporate headquarters. This comprehensive approach channels (including detailing visits, accurately and consistently delivered across marketing Defendants consider this high level speaker events, and advertising) and in each sales territory. marketing their drugs. of coordination and uniformity crucial to successfully 43.

through national and regional sales Defendants ensure marketing consistency nationwide liaisons, the company employees who representative training; national training of local medical single sets of visual aids, speaker respond to physician inquiries; centralized speaker training; coordinated advertising. Defendants' slide decks, and sales training materials; and nationally to emphasize to prescribed talking sales representatives and physician speakers were required rode along with them periodically to points, sales messages, and slide decks, and supervisors

both check on their performance and compliance.

#8.15 Page 16 of 57 East Baton Rouge Parish Clerk of Court

44. advertising opioids in Louisiana through unbranded Defendants also deceptively marketed name a specific opioid). This opioid use generally but does not (i.e. advertising that promotes third parties. Defendants and disseminated by independent advertising was ostensibly created and acted in concert with disseminated by these third parties controlled the deceptive messages of chronic pain by funding, promote opioids for the treatment them to falsely and misleadingly Much as Defendants distributing this unbranded advertising. directing, reviewing, editing, and and speaker programs, "core messages" via their own detailers controlled the distribution of their publications, distribution of these messages in scientific Defendants similarly controlled the end, Defendants conferences and seminars. To this treatment guidelines, CMEs, and medical they originated from to help control those messages when used third-party public relations firms

third-parties. 45.

unbranded advertising to avoid regulatory Defendants also marketed through third-party, to and typically is not reviewed by the FDA. scrutiny because that advertising is not submitted the advertising to give the false appearance that Defendants also used third-party, unbranded and objective source. Defendants used third deceptive messages came from an independent to carry out and conceal their scheme to deceive parties that they funded, directed, and controlled of long-term opioid use for chronic pain. doctors and patients about the risks and benefits contradicted what they said in their branded Defendants' deceptive unbranded marketing often

materials reviewed by the FDA. 46.

who, upon information and belief, were Defendants also utilized a small circle of doctors their public positions supported the use of selected, funded, and elevated by Defendants because known as "key opinion leaders" or "KOLs." opioids to treat chronic pain. These doctors became 47.

or on their advisory boards and to give Defendants paid KOLs to serve as consultants KOLs become respected industry experts. talks or present CMEs, and their support helped these the benefits of opioids to treat chronic pain, As they rose to prominence, these KOLs touted goals. KOLs' professional reputations repaying Defendants by advancing their marketing

#8.16 East Baton Rouge Parish Clerk of Court Page 17 of 57

pro-opioid message, even in activities that were became dependent on continuing to promote a

not directly funded by Defendants. 48.

their names to books and articles, and KOLs have written, consulted on, edited, and lent opioid therapy. Defendants created given speeches and CMEs supportive of chronic Defendants suggested or chose and then opportunities for KOLs to participate in research studies KOLs. By contrast, Defendants did not cited and promoted favorable studies or articles by their doctors unsupportive or critical of chronic support, acknowledge, or disseminate publications of

opioid therapy. 49.

guidelines that Defendants' KOLs also served on committees that developed treatment

chronic pain, and on the boards of pro-opioid strongly encourage the use of opioids to treat 1.1 present CMEs. Defendants advocacy groups and professional societies that develop, select, and their KOLs. The 2016 were able to direct and exert control over each of these activities through

CDC Guideline recognizes that treatment guidelines can "change prescribing practices. 1 1' 50.

spread Pro-opioid doctors are one of the most important avenues that Defendants use to opioid use. their false and deceptive statements about the risks and benefits of long-term and Defendants know that doctors rely heavily and less critically on their peers for guidance,

KOLs provide the false appearance of unbiased and reliable support for chronic opioid therapy.

For example, the State of New York found in its settlement with Purdue that the Purdue website

In the Face of Pain failed to disclose that doctors who provided testimonials on the site were

paid by Purdue and concluded that Purdue's failure to disclose these financial connections

potentially misled consumers regarding the objectivity of the testimonials.

51.

Thus, even though some of Defendants' KOLs have recently moderated or conceded the

lack of evidence for many of the claims they made, those admissions did not reverse the effect of

the false and deceptive statements that continue to appear nationwide and throughout the

Louisiana in Defendants' own marketing as well as treatment guidelines, CMEs and other

seminars, scientific articles and research, and other publications available in paper or online.

#8.17 Page 18 of 57 East Baton Rouge Parish Clerk of Court

52. of the most including many of the same ones. Two Defendants utilized many KOLs,

prominent are described below. 53. the Department Russell Portenoy, former Chairman of For example, Defendants used Dr. York, to further their at Beth Israel Medical Center in New of Pain Medicine and Palliative Care fees, and honoraria received research support, consulting marketing campaign. Dr. Portenoy consultant to Purdue (among others), and was a paid from Cephalon, Endo, Janssen, and

Cephalon and Purdue. 54.

promoted the widespread use of opioid analgesic In exchange, Dr. Portenoy successfully Society Dr. Portenoy served on the American Pain pain relievers throughout the United States. which Medicine ("AAPM") Guidelines Committees, ("APS") / American Academy of Pain to treat chronic pain in 1997 and 2009. Dr. endorsed the use of opioid analgesic pain relievers the American Pain Foundation ("APF"), an Portenoy was also a member of the board of entirely funded by Defendants. advocacy organization (a/k/a "Front Group") almost 55.

promoting opioid analgesic pain Dr. Portenoy also made frequent media appearances Dr. Portenoy appeared on Good Morning relievers and spreading misrepresentations. For example, to treat chronic pain. On this widely- America in 2010 to discuss the use of opioids long-term across the country, Dr. Portenoy claimed: viewed television program, broadcast in Louisiana and If a person does not have a history, a "Addiction when treating pain, is distinctly uncommon. history in the family of substance abuse, personal history, of substance abuse, and does not have a can feel very assured that that and does not have a very major psychiatric disorder, most doctors

person is not going to become addicted."19 56.

lectures in the late 1980s and '90s Dr. Portenoy later conceded that he "gave innumerable Portenoy falsely claimed that fewer about addiction that weren't true." In those lectures, Dr. According to Dr. Portenoy, he and than 1% of patients would become addicted to opioids. glossed over their risks because the other doctors promoting opioids overstated their benefits and

ABC News (Aug. 30, 2010) (emphasis added). 19 Good Morning America television broadcast,

#8.18 Page 19 of 57 East Baton Rouge Parish Clerk of Court

that "[dlata about the opioids. Dr. Portenoy also conceded primary goal was to "destigmatize" I teach about pain 2° Portenoy candidly explained: "Did effectiveness of opioids does not exist." Well, . . . I therapy, in a way that reflects misinformation? management, specifically about opioid further market their this scientific backing in order to guess I did."21 Defendants purchased was contrary use all while knowing that the propaganda highly-additive product for widespread

to the known side effects. 57. and used Dr. Lynn Webster, the co-founder As another example of a KOL, Defendants Utah, to further their Clinical Research in Salt Lake City, Chief Medical Director of Lifetree board member of Webster was President and is a current marketing campaign. In 2013, Dr. Webster is a Senior supports chronic opioid therapy. Dr. AAPM, a front group that ardently supplements journal that published Endo special advertising Editor of Pain Medicine, the same by Cephalon, the author of numerous CMEs sponsored touting Opana ER. Dr. Webster was funding from Dr. Webster was receiving significant Endo, and Purdue. At the same time, from Cephalon). Defendants (including nearly $2 million 58.

Dr. Webster was under investigation for During a portion of his time as a KOL, of Justice's Drug Enforcement Agency, which overprescribing by the United States Department ended without any criminal charges being raided his clinic in 2010.22 Although the investigation of former patients at the Lifetree Clinic died filed in 2014, more than 20 of Dr. Webster's

opioid overdoses.23 59.

the Opioid Risk Tool, a five question, one- Ironically, Dr. Webster created and promoted that purportedly allows doctors to manage minute screening tool relying on patient self-reports to or abuse opioids. The claimed ability to pre- the risk that their patients will become addicted tool in giving doctors confidence to sort patients likely to become addicted is an important references to screening appear in various prescribe opioids long-term, and for this reason,

ST. J., Dee. 17, 2012. -Drug Champion Has Second Thoughts, WALL 20 Thomas Catan & Evan Perez, A Pain

21 Id.

22 http://www.medpagetoday.com/Neurology/PainManagement/37441.

" See Id.

#8.19 Page 20 of 57 East Baton Rouge Parish Clerk of Court

Tool appear on, or are of Dr. Webster's Opioid Risk industry-supported guidelines. Versions and Purdue. linked to, websites run by Endo, Janssen, 60. by Purdue titled, via webinar, a program sponsored In 2011, Dr. Webster presented, Dr. Webster recommended Balancing the Need and the Risk. Managing Patient's Opioid Use: way to prevent "overuse of testing, and patient agreements as a use of risk screening tools, urine was intended to reach This webinar was available to and prescriptions" and "overdose deaths."

Louisiana doctors. 61. -addiction," the proponent of the concept of "pseudo Dr. Webster also was a leading indications of be seen not as warnings, but as notion that addictive behaviors should the two was to description, the only way to differentiate undertreated pain. In Dr. Webster's Avoiding he and his co-author wrote in a book entitled increase a patient's dose of opioids. As faced with a book that is still available online, when Opioid Abuse While Managing Pain (2007), first dose "in most cases . . . should be the clinician's signs of aberrant behavior, increasing the reversed book to doctors. Years later, Dr. Webster response." Notably, Endo distributed this obviously became too much of an excuse to himself, acknowledging that "[pseudo-addiction]

give patients more medication."24 62.

unbiased and independent patient Defendants also entered into arrangements with seemingly for the treatment of chronic pain. Under the and professional organizations to promote opioids Groups" generated treatment guidelines, direction and control of Defendants, these "Front opioid therapy. They also assisted unbranded materials, and programs that favored chronic against regulatory changes that would Defendants by responding to negative articles, by advocating evidence, and by conducting outreach to limit opioid prescribing in accordance with the scientific

vulnerable patient populations targeted by Defendants, 63.

control over programs and materials Defendants funded these Front Groups and exercised and approving their content, and by funding created by these groups by collaborating on, editing, that the Groups would generate only the their dissemination. In doing so, Defendants made sure

(Feb. 19, Fuels Painkiller Boom, MILWAUKEE WISC. J. SENTINEL 24 John Fauber & Ellen Gabler, Networking 2012).

#8.20 Page 21 of 57 East Baton Rouge Parish Clerk of Court

themselves out as Despite this, the Front Groups held messages Defendants wanted to distribute.

independent. 64. Groups including and Purdue utilized many Front Defendants Cephalon, Endo, Janssen, the Federation of American Geriatrics Society ("AGS"), the American Pain Society ("APS"), ("ACPA"), American American Chronic Pain Association State Medical Boards ("FSMB"), and Pain & Policy National Pain Foundation ("NPF") Society of Pain Education ("ASPE"),

Studies Group ("PPSG"). 65. while Foundation ("APF") as a Front Group Defendants utilized the American Pain 2012 when it than $10 million from 2007 until May opioid manufacturers paid the APF more provided more than half that funding, and Purdue ceased operations. Notably, Endo provided

approximately $1.7 million to the APF. 66.

reporters, and policymakers that touted the APF published articles for doctors, patients, 25 their risks, particularly the risk of addiction, benefits of opioids for chronic pain and trivialized not by tapering and that opioid withdrawal is that opioid dependence could be easily addressed indefinitely without added risk,27 long-term difficult,26 doctors could increase opioid dosages quality of life,28 and Purdue's OxyContin provided opioid use improved patients' function and for also launched a campaign to promote opioids 12 hours of continuous pain relief.29 APF rates of addiction and other adverse outcomes — returning veterans, which has contributed to high APF also engaged in a significant multimedia including death — among returning soldiers. — to educate patients about their "right" to campaign — through radio, television and the internet

in Pain (2007) (sponsored by Treatment Options: A Guide for People Living 25 American Pain Foundation's Guide to American Pain Foundation's A Policymaker's Cephalon and Purdue) (still available online); by Purdue) (still available online). Understanding Pain and Its Management (sponsored (sponsored by Guide to Understanding Pain and Its Management 26 American Pain Foundation's A Policymaker's Purdue) (still available online). in Pain (2007) (sponsored by Treatment Options: A Guide for People Living 22 American Pain Foundation's Guide to online); American Pain Foundation's A Policymaker's Cephalon and Purdue) (still available American Pain (sponsored by Purdue) (still available online). Understanding Pain and Its Management (still Pain and Its Management (sponsored by Purdue) Foundation's A Policymaker's Guide to Understanding available online). for sale online); American (sponsored by Endo, Cephalon and Purdue) (remains 28 Responsible °plaid Prescribing by Cephalon and for People Living in Pain (2007) (sponsored Pain Foundation's Treatment Options: A Guide Pain in the Older Patient (sponsored by Endo). Purdue) (still available online); CME entitled Persistent

29 American Pain Foundation.

#8.21 Page 22 of 57 East Baton Rouge Parish Clerk of Court

nationally and programs and materials were available pain treatment, namely opioids. All of the

were intended to reach Louisiana residents. 67.

University of Utah who received funding from In addition to Perry Fine (a KOL from the Portenoy, and Scott Fishman (a KOL from the Janssen, Cephalon, Endo, and Purdue) Russell Responsible Opioid Prescribing, a publication University of California, Davis who authored served on APF's Board and reviewed its sponsored by Cephalon and Purdue), all of whom was an employee of a public relations firm that publications, another board member, Lisa Weiss,

worked for both Purdue and APF. 68.

budget came from pharmaceutical In 2009 and 2010, more than 80% of APF's operating $2.3 million from industry sources industry sources. In 2009, the APF received approximately projected receipts of roughly $2.9 out of total income of about $2.85 million. In 2010, the APF million. By 2011, the APF was million from drug companies, out of total income of about $3.5 Cephalon, Endo, and others to s. entirely dependent on incoming grants from Defendants Purdue, Portenoy, explained, the lack avoid using its line of credit. As one of its board members, Russell

of funding diversity was one of the biggest problems at the APF. 69.

advocacy Contrary to reality, the APF held itself out as an independent patient legislative initiatives organization. The APF often engaged in grassroots lobbying against various The APF was often that might limit opioid prescribing, and thus the profitability of its sponsors. activities, including called upon to provide "patient representatives" for Defendants' promotional the APF functioned for Purdue's Partners Against Pain and Janssen's Let's Talk Pain. In reality, as early as 2001, largely as an advocate for the interests of Defendants, not patients. Indeed, align its Purdue told the APF that the basis of a grant was Purdue's desire to "strategically In other words, the investments in nonprofit organizations that share [its] business interests." use of opioids Defendants paid the APF to promote, market, and "legitimize" the widespread

both in the medical community and throughout the nation. 70.

several In practice, the APF operated in close collaboration with opioid makers. On at Front Group occasions, representatives of the drug companies, often at informal meetings

#8.22 Page 23 of 57 East Baton Rouge Parish Clerk of Court

to pursue. The APF then and publications for the APF conferences, suggested activities knowing that drug to fund these activities and publications, submitted grant proposals seeking conceived as a result of these communications. companies would support projects 71. project funded by projects for drug companies. One The APF assisted in other marketing (2009), Guide: Covering Pain and Its Management another drug company, APF Reporter's document. as part of the company's own training republished text that was originally created 72. APF used grants, but even then it directed how the The same drug company made general damaging state for funding to address a potentially them. In response to an APF request responded, generally, the company representative Medicaid decision related to pain medications which to year — this would be a very good issue on "I provided an advocacy grant to APF this

use some of that. How does that work?" 73.

drug company was not unique, but The close relationship between the APF and the

mirrors relationships among the APF and Defendants. 74.

began an inquiry in order to In May 2012, the United States Senate Finance Committee the APF and the manufacturers of opioid determine the links, financial and otherwise, between damage to the APF's credibility as an painkillers. The investigation caused considerable stopped funding it. Within days of being "objective and neutral third party," and Defendants to dissolve the organization "[d]ue to targeted by the Senate investigation, the APF's board voted to exist, effective immediately." irreparable economic circumstances." The APF "cease[d] 75.

issued treatment guidelines and The American Academy of Pain Medicine ("AAPM") to Defendants' deceptive marketing of hosted various medical education programs essential and funding of Defendants. chronic opioid therapy with the assistance, prompting, involvement, 76,

than $2.2 million since 2009. For these efforts, opioid manufacturers paid AAPM more members paid $25,000 per year (on The AAPM maintained a corporate relations council, whose allowing members to present top of other funding) to participate. The benefits included

#8.23 Page 24 of 57 East Baton Rouge Parish Clerk of Court

annual meeting symposia in connection with the AAPM's educational programs at off-site dinner describes the annual event other resort locations. The AAPM held in Palm Springs, California, or in the corporate education programs to doctors. Membership as an "exclusive venue" for offering with AAPM executives and marketing staff to meet relations council also allows drug company Cephalon and settings. Defendants Endo, Purdue, executive committee members in small doctors who attended and presented deceptive programs to Actavis were members of the council

this annual event. s. 77.

friendly," with Endo advisors and speakers Endo considers the AAPM as "industry conferences, funded its CMEs, and distributed among its active members. Endo attended AAPM on by the AAPM heavily emphasized sessions its publications. The conferences sponsored top industry-supported KOLs Perry Fine, Russell opioids. AAPM's presidents have included named Dr. Webster President of the AAPM Portenoy, and Lynn Webster. Notably, the AAPM past AAPM President, Dr. Scott Fishman, while he was under investigation by the DEA. Another the forefront" of teaching that "the risks of stated that he would place the organization "at

addiction are . . . small and can be managed."3° 78.

both their significant and regular Defendants were able to influence the AAPM through organization. funding and the leadership of pro-opioid KOLs within the 79.

in securing acceptance In addition, treatment guidelines have been particularly important guidelines, especially the general for chronic opioid therapy. Doctors rely upon these treatment who are neither experts nor trained in practitioners and family doctors targeted by Defendants, only directly inform doctors' prescribing the treatment of chronic pain. Treatment guidelines not and referenced by third-party payors in practices, but are cited throughout the scientific literature indications. Pharmaceutical sales determining whether they should cover treatments for specific discussed treatment guidelines with representatives employed by Endo, Actavis, and Purdue

doctors during individual sales visits.

of MD., Professor of Anesthesiology and Pain Medicine, Chief 3° Interview by Paula Moyer with Scott M. Fishman, the Division of Pain Medicine, Univ. of Cal., Davis (2005), http://www.medscape.org/viewarticle/500829.

#8.24 Page 25 of 57 East Baton Rouge Parish Clerk of Court

80. issued a consensus statement, American Pain Society jointly In 1997, the AAPM and the endorsed opioids to treat chronic Treatment of Chronic Pain, which The Use of Opioids for the to opioids was low. The co- that patients would become addicted pain and claimed that the risk Purdue and Dr. Portenoy was at the time a paid speaker for author of the statement, Dr. Haddox, website until 2011 and statement remained on AAPM' s was the sole consultant. The consensus

remains accessible on the Internet. 81. and guidelines in 2009 ("AAPM/APS Guidelines") The AAPM and APS issued their own 21 panel members to treat chronic pain. Fourteen of the continued to recommend the use of opioids Perry Fine of the including KOLs Dr. Portenoy and Dr. who drafted the AAPM/APS Guidelines, from Janssen, Cephalon, Endo, and Purdue. University of Utah, received financial support 82. pain, as "safe and effective" for treating chronic The 2009 Guidelines promote opioids for conclude that the risk of addiction is manageable despite acknowledging limited evidence, and Professor One panel member, Dr. Joel Saper, Clinical patients regardless of past abuse histories. & and founder of the Michigan Headache of Neurology at Michigan State University Guidelines panel because of his concerns that the 2009 Neurological Institute, resigned from the to the companies, including Defendants, made were influenced by contributions that drug These AAPM/APS Guidelines have been a sponsoring organizations and committee members. but and have influenced not only treating physicians particularly effective channel of deception Notably, the Guidelines have been cited 732 also the body of scientific evidence on opioids. in Louisiana during the relevant time period, times in academic literature, were disseminated the Journal of Pain. are still available online, and were reprinted in 83.

the 2009 Guidelines without disclosing the Defendants widely referenced and promoted

acknowledged lack of evidence to support them. 84.

combined their efforts through the Pain In another "Front Group" example, Defendants as an APF project. PCF is comprised of Care Forum ("PCF"), which began in 2004 Cephalon, Endo, Janssen, and Purdue) and representatives from opioid manufacturers (including

#8.25 Page 26 of 57 East Baton Rouge Parish Clerk of Court

Between received substantial funding from Defendants. various Front Groups, almost all of which and in political approximately $880,000,000 on lobbyists 2006 and 2015, this Front Group spent of the of registered lobbyists working for members campaign donations. In Louisiana, the number States in 2015. Pain Care Forum ranked 4th in the United 85.

that opioids can and should be used to treat To convince doctors and patients in Louisiana and helpful. them that long-term opioid use is both safe chronic pain, Defendants had to convince and those doctors and patients about the risks Knowing that they could do so only by deceiving were made claims that were not supported by or benefits of long-term opioid use, Defendants pronouncements by and guidance from the FDA contrary to the scientific evidence. Even though that their claims were false and deceptive, and the CDC based on that evidence confirm their KOLs or Front Groups to correct them, Defendants have not corrected them, or instructed

and continue to spread them today. 86.

Defendants deceptively minimized To convince doctors and patients that opioids are safe, the risk of addiction, through and failed to disclose the risks of long-term opioid use, particularly contradicted by the FDA and CDC. a series of misrepresentations that have been conclusively other and created the dangerously These misrepresentations, described below, reinforced each was low-risk because most patients misleading impression that: (1) starting patients on opioids greatest risk of addiction could be would not become addicted, and because those who were at of addiction probably were not readily identified and managed; (2) patients who displayed signs (3) the use of higher opioid addicted and, in any event, could easily be weaned from the drugs; tolerance to the drugs, do doses, which many patients need to sustain pain relief as they develop abuse and overdose and are not pose special risks; and (4) abuse-deterrent opioids both prevent these misrepresentations, inherently less addictive. Defendants have not only failed to correct

they continue to make them today. 87.

that addiction is First, Defendants falsely claimed that the risk of addiction is low and illicitly; and failed to unlikely to develop when opioids are prescribed, as opposed to obtained Some illustrative examples disclose the greater risk of addiction with prolonged use of opioids.

of these false and deceptive claims are described below:

#8.26 27 of 57 East Baton Rouge Parish Clerk of Court Page

education brochure to be a. Actavis's predecessor caused a patient is possible, but "less distributed in 2007 that claimed opioid addiction Upon information and likely if you have never had an addiction problem." predecessor's marketing belief, based on Actavis's acquisition of its continued to use this materials along with the rights to Kadian, Actavis brochure in 2009 and beyond. Options: A Guide for b. Cephalon and Purdue sponsored APF's Treatment addiction is rare and People Living with Pain (2007), which instructed that escalations, obtaining limited to extreme cases of unauthorized dose sources, or theft. This duplicative opioid prescriptions from multiple publication is still available online. which claimed in 2009 c. Endo sponsored a website, Painknowledge.com, usually do not become that Ipleople who take opioids as prescribed "Did you know? addicted." Another Endo website, PainAction.com, stated addicted to the opioid Most chronic pain patients do not become medications that are prescribed for them." logo entitled Living with d. Endo distributed a pamphlet with the Endo "Most health care Someone with Chronic Pain, which stated that: most people do not providers who treat people with pain agree that appeared on the Endo develop an addiction problem." A similar statement website www.opana.com. a patient education e. Janssen reviewed, edited, approved, and distributed Older Adults (2009), guide entitled Finding Relief: Pain Management for are addictive, and which described as "myth" the claim that opioids rarely addictive asserted as fact that "[m]any studies show that opioids are when used properly for the management of chronic pain." (last updated f. Janssen currently runs a website, Prescriberesponsibly.com addiction are July 2, 2015), which claims that concerns about opioid "overestimated." Pain & Purdue sponsored APF's A Policymaker's Guide to Understanding g. prescribed Its Management, which claims that less than 1% of children due to dpioids will become addicted and that pain is undertreated is still "misconceptions about opioid addiction[]." This publication available online. omitted h. Detailers for Purdue, Endo, Janssen, and Cephalon minimized or the any discussion with doctors of the risk of addiction; misrepresented potential for abuse of opioids with purportedly abuse-deterrent formulations; and routinely did not correct the misrepresentations noted above. 88.

evidence. As These claims (misrepresentations) are contrary to longstanding scientific evidence" of the noted in the 2016 CDC Guideline endorsed by the FDA, there is "extensive term for opioid "possible harms of opioids (including opioid use disorder [an alternative serious risks, addiction])." The Guideline points out that "[o]pioid pain medication use presents for 3 months substantially including . . . opioid use disorder" and that "continuing opioid therapy

increases risk for opioid use disorder."

#8.27 Page 28 of 57 East Baton Rouge Parish Clerk of Court

89.

Defendants' claims about the low risk of The FDA further exposed the falsity of for ER/LA opioids in 2013 and for IR opioids addiction when it announced changes to the labels that "most opioid drugs have 'high potential for in 2016. In its announcements, the FDA found a substantial risk of misuse, abuse, NOWS abuse" and that opioids "are associated with overdose, and death." According to the FDA, [neonatal opioid withdrawal syndrome], addiction, with long-term opioid use, including "risks of because of the "known serious risks" associated doses, and because of the greater risks of addiction, abuse, and misuse, even at recommended "in patients for whom alternative treatment overdose and death," opioids should be used only further acknowledged that the risk is not options" like non-opioid drugs have failed. The FDA "can occur in patients appropriately limited to patients who seek drugs illicitly; addiction

prescribed [opioids]." 90.

drug labels caution that opioids The warnings on Defendants' own FDA-approved which can lead to overdose and death," "expose() users to risks of addiction, abuse and misuse, for abuse," and that addiction "can that the drugs contain "a substance with a high potential

occur in patients appropriately prescribed" opioids. 91.

that the signs of addiction Second, Defendants falsely instructed doctors and patients by prescribing more opioids. are actually signs of undertreated pain and should be treated — a term coined by Dr. David Defendants called this phenomenon "pseudo-addiction" Russell Portenoy, a KOL for Haddox, who went to work for Purdue, and popularized by Dr. that pseudo-addiction is Cephalon, Endo, Janssen, and Purdue — and falsely claimed of these deceptive claims are substantiated by scientific evidence. Some illustrative examples

described below: (2007), a. Cephalon and Purdue sponsored Responsible Opioid Prescribing by name," which taught that behaviors such as "requesting drugs doctor to "demanding or manipulative behavior," seeing more than one rather than obtain opioids, and hoarding, are all signs of pseudo-addiction, online. true addiction. Responsible Opioid Prescribing remains for sale to teach The 2012 edition, which also remains available online, continues that pseudoaddiction is real. which b. Janssen sponsored, funded, and edited the Let's Talk Pain website, that may in 2009 stated: "pseudo-addiction . . refers to patient behaviors from occur when pain is under-treated . . . . Pseudo-addiction is different

#8.28 East Baton Rouge Parish Clerk of Court Page 29 of 57

true addiction because such behaviors can be resolved with effective pain management."

c. Endo sponsored a National Initiative on Pain Control ("NIPC") CME program in 2009 titled Chronic Opioid Therapy: Understanding Risk While Maximizing Analgesia, which promoted pseudo-addiction by teaching that a patient's aberrant behavior was the result of untreated pain. Endo substantially controlled NIPC by funding NIPC projects; developing, specifying, and reviewing content; and distributing NIPC materials.

d. Purdue published a pamphlet in 2011 entitled Providing Relief Preventing Abuse, which described pseudo-addiction as a concept that "emerged in the literature" to describe the inaccurate interpretation of [drug-seeking behaviors] in patients who have pain that has not been effectively treated."

e. Purdue sponsored a CME program entitled Path of the Patient, Managing Chronic Pain in Younger Adults at Risk for Abuse. In a role play, a chronic pain patient with a history of drug abuse tells his doctor that he is taking twice as many hydrocodone pills as directed. The narrator notes that because of pseudoaddiction, the doctor should not assume the patient is addicted even if he persistently asks for a specific drug, seems desperate, hoards medicine, or "overindulges in unapproved escalating doses." The doctor treats this patient by prescribing a high-dose, long- acting opioid.

92.

Contrary to Defendants' false propaganda, the 2016 CDC Guideline rejects the concept

of pseudo-addiction. The Guideline does not recommend that opioid dosages be increased if a

patient is not experiencing pain relief. Instead, the Guideline explains that Iplatients who do not

experience clinically meaningful pain relief early in treatment . . are unlikely to experience pain

relief with longer-term use," and that physicians should "reassess[] pain and function within 1

month" in order to decide whether to "minimize risks of long-term opioid use by discontinuing

opioids" because the patient is "not receiving a clear benefit."

93.

Third, Defendants falsely instructed doctors and patients that addiction risk screening

tools, patient contracts, urine drug screens, and similar strategies allow them to reliably identify

and safely prescribe opioids to patients predisposed to addiction. These misrepresentations were

especially insidious because Defendants aimed them at general practitioners and family doctors

who lack the time and expertise to closely manage higher-risk patients on opioids. Defendants'

misrepresentations made these doctors feel more comfortable prescribing opioids to their

patients, and patients more comfortable starting on opioid therapy for chronic pain. Some

illustrative examples of these deceptive claims are described below:

a. Endo paid for a 2007 supplement in the Journal of Family Practice written by a doctor who became a member of Endo's speaker's bureau in 2010. The supplement, entitled Pain Management Dilemmas in Primary Care:

#8.29 Page 30 of 57 East Baton Rouge Parish Clerk of Court

of screening tools, claiming Use of Opioids, emphasized the effectiveness safely receive chronic opioid that patients at high risk of addiction could involving toxicology therapy using a "maximally structured approach" screens and pill counts. Managing Patient's Opioid Use: b. Purdue sponsored a 2011 webinar, that screening tools, urine Balancing the Need and Risk, which claimed of prescriptions" and tests, and patient agreements prevent "overuse "overdose deaths." in scientific conferences that "bad c. As recently as 2015, Purdue represented the addiction crisis and that apple" patients, not opioids, are the source of can safely prescribe once those "bad apples" are identified, doctors opioids without causing addiction. 94.

the falsity of these misrepresentations. Once again, the 2016 CDC Guideline confirms assessing the effectiveness of risk mitigation The Guideline notes that there are no studies contracts, urine drug testing, or pill counts widely strategies — such as screening tools, patient — "for improving outcomes related to overdose, believed by doctors to detect and deter abuse Guideline recognizes that available risk screening addiction, abuse, or misuse." As a result, the of patients as at low or high risk for (opioid] tools "show insufficient accuracy for classification not overestimate the ability of these tools to abuse or misuse" and counsels that doctors "should

rule out risks from long-term opioid therapy." 95.

of addiction and make doctors feel more Fourth, to downplay the risk and impact f. falsely claimed that opioid dependence can comfortable starting patients on opioids, Defendants is not a problem, and failed to disclose easily be addressed by tapering and that opioid withdrawal use. the increased difficulty of stopping opioids after long-term 96.

Persistent Pain in the Older Adult, For example, a CME sponsored by Endo, entitled tapering a patient's opioid dose by 10%- claimed that withdrawal symptoms can be avoided by Guide to Understanding Pain & 20% for 10 days. And Purdue sponsored APF's A Policynzaker's of physical dependence can often be Its Management, which claimed that "[slymptoms during discontinuation" without ameliorated by gradually decreasing the dose of medication

mentioning any hardships that might occur. 97.

of opioid withdrawal — which, Defendants deceptively minimized the significant symptoms cravings, anxiety, insomnia, abdominal as explained in the 2016 CDC Guideline, include drug

#8.30 Page 31 of 57 East Baton Rouge Parish Clerk of Court

abortion tachycardia (rapid heartbeat), spontaneous pain, vomiting, diarrhea, sweating, tremor, and addiction and the unmasking of anxiety, depression, and premature labor in pregnant women, opioid use. Yet of tapering, particularly after long-term — and grossly understated the difficulty dosage of opioids that the duration of opioid use and the the 2016 CDC Guideline recognizes or the need to taper opioids to prevent distressing prescribed should be "limit[ed]" to "minimize expected "physical dependence on opioids is an unpleasant withdrawal symptoms" because Guideline to opioids for more than a few days." The physiologic response in patients exposed high dosages be especially challenging after years on further states that "tapering opioids can the and highlights the difficulties, including because of physical and psychological dependence" of opioid enough to minimize symptoms and signs need to carefully identify "a taper slow The CDC tapers depending on the patient's response. withdrawal" and to "pause[] and restart[]" of different -quality studies comparing the effectiveness also acknowledges the lack of any "high is reduced or opioids are discontinued." tapering protocols for use when opioid dosage 98.

and patients could increase opioid dosages Fifth, Defendants falsely claimed that doctors at higher to disclose the greater risks to patients indefinitely without added risk and failed for critical to Defendants' efforts to market opioids dosages. The ability to escalate dosages was have absent this misrepresentation, doctors would long-term use to treat chronic pain because, and lower dosages did not provide pain abandoned treatment when patients built up tolerance

relief. Some illustrative examples are described below: for Kadian in 2007 that a. Actavis's predecessor created a patient brochure of your current dose. stated, "Over time, your body may become tolerant amount of pain relief. You may require a dose adjustment to get the right based on Actavis's This is not addiction." Upon information and belief, along with the rights acquisition of its predecessor's marketing materials in 2009 and beyond. to Kadian, Actavis continued to use these materials Options: A Guide for b. Cephalon and Purdue sponsored APF's Treatment some patients "need" People Living with Pain (2007), which claims that currently prescribed. a larger dose of an opioid, regardless of the dose dose" and are therefore The guide stated that opioids have "no ceiling This guide is still the most appropriate treatment for severe pain. available for sale online. which claimed in 2009 c. Endo sponsored a website, painknowledge.com, on the right dose of that opioid dosages may be increased until "you are medication for your pain." entitled Understanding d. Endo distributed a pamphlet edited by a KOL which was available Your Pain: Taking Oral Opioid Analgesics, website. In Q&A during the time period of this Complaint on Endo's it work later when I format, it asked "If I take the opioid now, will

#8.31 :Page 32 of 57 East Baton Rouge Parish Clerk of Court

dose can be increased. . . . You really need it?" The response is, "The won't 'run out' of pain relief." education guide entitled Finding Relief.' e. Janssen sponsored a patient (2009), which was distributed by its Pain Management for Older Adults limitations as "disadvantages" of sales force. This guide listed dosage any discussion of risks of increased other pain medicines but omitted opioid dosages. if a website promotes the notion that f. Purdue's In the Face of Pain what, in the patient's view, is a patient's doctor does not prescribe should find another doctor who sufficient dosage of opioids, he or she will. Pain Policymaker's Guide to Understanding h. Purdue sponsored APF's A dosage escalations are "sometimes & Its Management, which taught that not disclose the risks from high necessary," even unlimited ones, but did online. opioid dosages. This publication is still available of Management Options Purdue sponsored a CME entitled Overview CME was edited by a KOL that is still available for CME credit. The anti-inflammatory drugs) and and taught that NSAlDs (nonsteroidal dosages. other drugs, but not opioids, are unsafe at high on the Problems of Drug Purdue presented a 2015 paper at the College organization in the US Dependence, the "the oldest and largest to substance use and dedicated to advancing a scientific approach between opioid addictive disorders,"31 challenging the correlation dosage and overdose. 99.

claims conflict with available scientific As confirmed by the FDA and CDC, these the "[blenefits of high-dose opioids for evidence. As the CDC explains in its 2016 Guideline, for serious harms related to opioid therapy chronic pain are not established" while the "risks the CDC explains that "there is now an increase at higher opioid dosage." More specifically, overdose risk is increased at higher opioid established body of scientific evidence showing that risk for opioid use disorder, respiratory dosages." The CDC adds that "there is an increased the CDC advises doctors to "avoid depression, and death at higher dosages." Accordingly, per day. increasing dosages" above 90 morphine milligram equivalents 100.

by the FDA. In 2013, the The 2016 CDC Guideline reinforces earlier findings announced a relationship between increasing opioid FDA acknowledged "that the available data do suggest the FDA noted that studies "appear to dose and risk of certain adverse events." For example, -dose opioid use and the risk of overdose credibly suggest a positive association between high

and/or overdose mortality."

31 www.cpdd.org.

#8.32 Page 33 of 57 East Baton Rouge Parish Clerk of Court

101. of of the so-called abuse-deterrent properties Finally, Defendants' deceptive marketing and impressions that these opioids can curb addiction some of their opioids has created false that they primary care physicians, nearly half reported abuse. Indeed, in a 2014 survey of 1,000 1 • less addictive.32 believed abuse-deterrent formulations are inherently 102.

claims about the ability of their "abuse- More specifically, Defendants made misleading example, Endo's advertisements for the 2012 deterrent opioid formulations" to deter abuse. For was designed to be crush resistant, in a way reformulation of Opana ER falsely claimed that it the contrary, the FDA warned in a 2013 letter that suggested it was more difficult to abuse. To provide a reduction in oral, intranasal or that there was no evidence Endo's design "would studies showed that Opana ER could still intravenous abuse." Moreover, Endo's own concealed that "[n]o studies" support the notion be ground and chewed. The 2016 CDC Guideline states strategy for deterring or preventing that "abuse-deterrent technologies [are] a risk mitigation — "do not prevent opioid abuse abuse," noting that the technologies — even when they work can still be abused by nonoral through oral intake, the most common route of opioid abuse, and

routes." 103.

of long-term opioid use These numerous, longstanding misrepresentations of the risks to discount those risks. spread by Defendants successfully convinced doctors and patients

Defendants Grossly Overstated the Benefits of Chronic Opioid Therapy 104.

treat chronic pain, To convince doctors and patients that opioids should be used to upside to long-term opioid use. Defendants also had to persuade them that there was a significant evidence to determine the But as the 2016 CDC Guideline makes clear, there is "insufficient CDC found that "[n]o long-term benefits of opioid therapy for chronic pain." In fact, the no opioids for chronic evidence shows a long-term benefit of opioids in pain and function versus -controlled randomized pain with outcomes examined at least 1 year later (with most placebo beneficial and less trials < 6 weeks in duration)" and that other treatments were more or equally of evidence to support harmful than long-term opioid use. The FDA also recognized the lack

A National Survey of Primary Care Physicians, 175(2) 32 Catherine S. Hwang, et al., Prescription Drug Abuse: JAMA INTERN. MED, 302-4 (Dec. 8, 2014).

#8.33 Page 34 of 57 East Baton Rouge Parish Clerk of Court

and well- stated that it was "not aware of adequate long-term opioid use. In 2013, the FDA and 12 weeks." Despite this, Defendants falsely controlled studies of opioids use longer than opioid use and falsely and misleadingly suggested misleadingly touted the benefits of long-term failed to scientific evidence. Not only have Defendants that these benefits were supported by continue to make them today. correct these false and deceptive claims, they 105.

that long-term opioid use improved patients' For example, Defendants falsely claimed examples are described below: function and quality of life. Some illustrative that claimed that the use of Kadian to a. Actavis distributed an advertisement return to work, relieve "stress on treat chronic pain would allow patients to patients enjoy their lives. your body and your mental health," and help that the use of Opana ER for Endo distributed advertisements that claimed b. demanding tasks like chronic pain would allow patients to perform portrayed seemingly healthy, construction work or work as a chef and unimpaired subjects. education guide entitled Finding c. Janssen sponsored and edited a patient — which states as "a Relief Pain Management for Older Adults (2009) to live normally." The fact" that "opioids may make it easier for people opioid use, including guide lists expected functional improvements from sex, walking, and sleeping through the night, returning to work, recreation, climbing stairs. OxyContin in 2012 in medical d. Purdue ran a series of advertisements for studies featuring journals entitled "Pain vignettes," which were case several months and patients with pain conditions persisting over implied that recommending OxyContin for them. The advertisements ,OxyContin improves patients' function. and distributed by e. Responsible Opioid Prescribing (2007), sponsored opioids, by itself, Cephalon, Endo and Purdue, taught that relief of pain by online. improved patients' function. The book remains for sale Options: A Guide for f. Cephalon and Purdue sponsored APF's Treatment that opioids People Living with Pain (2007), which counseled patients guide was available "give [pain patients] a quality of life we deserve." The online until APF ceased operations in 2012. in 2009 that with Endo's NIPC website painknowledRe.com claimed g. may find you are opioids, "your level of function should improve; you such as work and now able to participate in activities of daily living, pain was worse." hobbies, that you were not able to enjoy when your life (as well as Elsewhere, the website touted improved quality of grant request that "improved function") as benefits of opioid therapy. The intent to Endo approved for this project specifically indicated NIPC's tracked visits to make misleading claims about function, and Endo closely the site. of CMEs titled h. Endo was the sole sponsor, through NIPC, of a series chronic opioid Persistent Pain in the Older Patient, which claimed that symptoms therapy has been "shown to reduce pain and improve depressive webcast. and cognitive functioning." The CME was disseminated via

#8.34 Page 35 of 57 East Baton Rouge Parish Clerk of Court

a website, Let's Talk Pain, in 2009, i. Janssen sponsored, funded, and edited Janssen claiming that opioids which featured an interview edited by This video is still available allowed a patient to "continue to function." today on YouTube. distribution of APF's A Purdue sponsored the development and J. & Its Management, which Policymaker's Guide to Understanding Pain shown that opioids are claimed that "multiple clinical studies" have health, and health- effective in improving daily function, psychological The Policymaker's Guide related quality of life for chronic pain patients." available online today. was originally published in 2011 and is still sales representatives have k. Purdue's, Cephalon's, Endo's, and Janssen's that opioids will improve conveyed and continue to convey the message patient function. 106.

Most recently, the 2016 CDC These claims are unsupported in scientific literature. is no good evidence that opioids improve Guideline approved by the FDA concluded that "there relief of pain is unlikely." (Emphasis pain or function with long-term use, and . . complete its 2016 Guideline: added). The CDC reinforced this conclusion throughout in pain and function a. "No evidence shows a long-term benefit of opioids at least 1 year versus no opioids for chronic pain with outcomes examined later . . . ." use, the clinical b. "Although opioids can reduce pain during short-term whether pain evidence review found insufficient evidence to determine improves with relief is sustained and whether function or quality of life long-term opioid therapy." pain or function with c. "[E]vidence is limited or insufficient for improved for which long-term use of opioids for several chronic pain conditions headache, and opioids are commonly prescribed, such as low back pain, fibromyalgia." 107,

cause distress and inability The CDC also noted that the risks of addiction and death "can

to fulfill major role obligations." 108.

repudiated Defendants' The 2016 CDC Guideline was not the first time a federal agency In 2010, the FDA warned Actavis, in claim that opioids improved function and quality of life. "fwle are not aware of substantial response to its advertising described in Paragraph 39, that the magnitude of the effect of the evidence or substantial clinical experience demonstrating that 1 drug-related side effects patients drug [Kadian] has in alleviating pain, taken together with any on a patient's work, physical and may experience . . , results in any overall positive impact

#8.35 Page 36 of 57 East Baton Rouge Parish Clerk of Court

FDA sent a enjoyment of life."33 And in 2008, the mental functioning, daily activities, or patients who are making it clear "that [the claim that] warning letter to an opioid manufacturer, function, and improvement in their overall function, social treated with the drug experience an evidence or has not been demonstrated by substantial ability to perform daily activities . .

substantial clinical experience." 109.

emphasized or exaggerated the risks of Defendants also falsely and misleadingly anti-inflammatory drugs), so that doctors and competing products like NSAlDs (nonsteroidal treatment of chronic pain. Once again, these patients would, instead, use opioids for the by and guidance from the FDA misrepresentations by Defendants contravene pronouncements the FDA changed the labels for ER/LA and CDC based on the scientific evidence. Indeed, opioids should only be used as a last resort opioids in 2013 and IR opioids in 2016 to state that non-opioid drugs "are inadequate." And "in patients for which alternative treatment options" like should be the first-line treatment for the 2016 CDC Guideline states that NSAIDs, not opioids,

chronic pain, particularly arthritis and lower back pain. 110.

unique among opioids in In addition, Purdue misleadingly promoted OxyContin as being fact, OxyContin does not last for providing 12 continuous hours of pain relief with one dose. In action. According to Purdue's 12 hours, a fact that Purdue has known at all times relevant to this of patients and in under 10 own research, OxyContin wears off in under six hours in one quarter 40% of their hours in more than half. This is because OxyContin tablets release approximately triggers a powerful initial active medicine immediately, after which release tapers. This period, when less medicine response, but provides little or no pain relief at the end of the dosing the FDA found in 2008 is released. This phenomenon is known as "end of dose" failure, and experience it. This not that a "substantial number" of chronic pain patients taking OxyContin it also makes only renders Purdue's promise of 12 hours of relief false and deceptive, experience toward the end OxyContin more dangerous because the declining pain relief patients next dosing period begins, of each dosing period drives them to take more OxyContin before the dependence. quickly increasing the amount of drug they are taking and spurring growing

& Commc'ns, to Doug Boothe, CEO, n Warning Letter from Thomas Abrams, Dir., FDA Div. of Mktg., Adver., Actavis Elizabeth LLC (Feb. 18, 2010), available at http://www.fda.gov/Drues/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbvFDA/WarningLett ersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm259240.htm.

#8.36 Page 37 of 57 East Baton Rouge Parish Clerk of Court

111. chronic pain even its opioids Actiq and Fentora for Cephalon deceptively marketed pain in opioid-tolerant their use to the treatment of cancer though the FDA expressly limited IR opioids. Neither are extremely powerful fentanyl-based individuals. Both Actiq and Fentora pain. Indeed, the FDA to be safe or effective for chronic drug is approved for or has been shown pain, and refused to marketing Actiq for anything but cancer expressly prohibited Cephalon from harm, including the chronic pain because of the potential approve Fentora for the treatment of a Public Health adverse events." The FDA also issued high risk of "serious and life-threatening who are should only be used for cancer patients Advisory in 2007 emphasizing that Fentora post- any other conditions, such as migraines, opioid-tolerant and should not be used for

operative pain, or pain due to injury. 112.

to conduct a well-funded campaign to Despite this, Cephalon conducted and continues not other non-cancer conditions for which it was promote Actiq and Fentora for chronic pain and this campaign, Cephalon used CMEs, speaker approved, appropriate, or safe. As part of by its sales representatives to give doctors programs, KOLs, journal supplements, and detailing and effective for treating non-cancer pain. the false impression that Actiq and Fentora are safe

For example: Management of a. Cephalon paid to have a CME it sponsored, Opioid-Based a supplement of Pain Persistent and Breakthrough Pain, published in that "clinically, Medicine News in 2009. The CME instructed doctors or noncancer- broad classification of pain syndromes as either cancer- and Fentora for related has limited utility" and recommended Actiq online. patients with chronic pain. The CME is still available of speaker programs for b. Cephalon's sales representatives set up hundreds Actiq and doctors, including many non-oncologists, which promoted Fentora for the treatment of non-cancer pain. a journal supplement c. In December 2011, Cephalon widely disseminated and Mitigation entitled "Special Report: An Integrated Risk Evaluation Oral Transmucosal Strategy for Fentanyl Buccal Tablet (FENTORA) and Clinical Oncology Fentanyl Citrate (ACTIQ)" to Anesthesiology News, sent to and Pain Medicine News, three publications that are News, The thousands of anesthesiologists and other medical professionals. causes of pain" — Special Report openly promotes Fentora for "multiple and not just cancer pain. 113.

the false impression that Actiq Cephalon's deceptive marketing gave doctors and patients chronic pain, but were also approved by and Fentora were not only safe and effective for treating

the FDA for such uses.

#8.37 Page 38 of 57 East Baton Rouge Parish Clerk of Court

114. address illicit and unlawful unfairly failed to report or Purdue also unlawfully and sales representatives have knowing about it for years. Purdue's prescribing of its drugs, despite prescribing its drugs. of doctors suspected of inappropriately maintained a database since 2002 authorities (as Purdue state medical boards or law enforcement Rather than report these doctors to list to demonstrate the high marketing to them, Purdue used the is legally obligated to do) or cease as less addictive) in same OxyContin that Purdue promoted rate of diversion of OxyContin (the copies of the drug because the manufacture and sale of generic order to persuade the FDA to bar Times, Purdue's senior In an interview with the Los Angeles the drug was too likely to be abused. pharmacies, in five years of investigating suspicious compliance officer acknowledged that the diversion of Purdue employees personally witnessed Purdue failed to take action, even where Purdue despite its knowledge of illegal prescribing, its drugs. The same was true of prescribers; shut down a Los Angeles clinic that prescribed did not report until years after law enforcement internally and that Purdue's district manager described more than 1.1 million OxyContin tablets expense of so, Purdue protected its own profits at the as "an organized drug ring." In doing

public health and safety. 115.

failure to set up an effective system for Like Purdue, Endo has been cited for its State In its settlement agreement with Endo, the identifying and reporting suspicious prescribing. sales representatives to report signs of abuse, of New York found that Endo failed to require bonuses to sales representatives for detailing diversion, and inappropriate prescribing; paid to or convicted for illegal prescribing; and failed prescribers who were subsequently arrested caused prescribers whose suspicious conduct had prevent sales representatives from visiting

them to be placed on a no-call list. 116.

Defendants identified and targeted As a part of their deceptive marketing scheme, For populations in the U.S., including Louisiana. susceptible prescribers and vulnerable patient marketing on primary care doctors, who were more example, Defendants focused their deceptive them drugs, but were less likely to be educated likely to treat chronic pain patients and prescribe of opioids and therefore more likely to accept about treating pain and the risks and benefits

Defendants' misrepresentations.

#8.38 39 57 East Baton Rouge Parish Clerk of Court Page of •

117.

who tend to suffer from chronic Defendants also targeted vulnerable patient populations these vulnerable patients even though the pain (e.g., elderly and veterans). Defendants targeted for them. For example, the 2016 CDC risks of long-term opioid use were significantly greater elderly patients taking opioids suffer from Guideline observes that existing evidence shows that and increased vulnerability to elevated fall and fracture risks, greater risk of hospitalization, concludes that there are "special adverse drug effects and interactions, The Guideline therefore that doctors use "additional risks of long-term opioid use for elderly patients" and recommends opioid use in elderly patients. The caution and increased monitoring" to minimize the risks of drugs (benzodiazepines) for same holds true for veterans, who are more likely to use anti-anxiety

post-traumatic stress disorder, which interact dangerously with opioids. 118.

the risks Defendants made, promoted, and profited from their misrepresentations about misrepresentations and benefits of opioids for chronic pain even though they knew that their experience over were false and deceptive. The history of opioids, as well as research and clinical a long list of the last 20 years, established that opioids were highly addictive and responsible for of this very serious adverse outcomes. The FDA and other regulatory bodies warned Defendants data, and adverse outcomes, and Defendants had access to scientific studies, detailed prescription of reports of adverse events, including reports of addiction, hospitalization, and deaths — all

which made clear the harms from long-term opioid use and that patients are suffering from

addiction, overdoses, and death in alarming numbers. More recently, the FDA and CDC issued

pronouncements based on the medical evidence that conclusively expose the known falsity of

Defendants' misrepresentations, and Endo and Purdue recently entered agreements prohibiting

them from making some of the same misrepresentations described in this Complaint in New

York.

119.

Moreover, at all times relevant to this Petition, Defendants took steps to avoid detection

and fraudulently concealed their deceptive marketing and unlawful, unfair, and fraudulent

conduct. For example, Defendants disguised their own role in the deceptive marketing of chronic

opioid therapy by funding and working through third parties like Front Groups and KOLs.

Defendants intentionally hid behind the assumed credibility and objectivity of these individuals

#8.39 Page 40 of 57 East Baton Rouge Parish Clerk of Court

Defendants' false endorse the accuracy and integrity of and organizations and relied on them to chronic pain. and benefits of long-term opioid use for and deceptive statements about the risks 120. the role in shaping, editing, and approving In addition, Defendants concealed their by these third parties. In reality, Defendants content of information and materials disseminated in emails, promotional and "educational" materials exerted considerable influence on these that Front Groups, and public relations companies correspondence, and meetings with KOLs, run by the For example, painknowledge.org, which is were not, and have not yet become, public. Janssen, Other Defendants, such as Purdue and NIPC, failed to disclose Endo' s involvement. direct role. operated similar websites that masked their own 121.

materials and the scientific literature Finally, Defendants manipulated their promotional it appear that these items were accurate, to provide the illusion of legitimacy and to make they were not. Further, Defendants distorted truthful, and supported by objective evidence when offered them as evidence for propositions the the meaning or import of studies they cited and

studies did not support. 122.

medical community, patients, and Thus, Defendants successfully concealed from the of the claims that the LDH now asserts. health care payers facts sufficient to arouse suspicion industry-wide fraud and could not LDH did not know of the existence or scope of Defendants' of reasonable diligence. have acquired such knowledge earlier through the exercise 123.

about the risks and benefits Defendants' misrepresentations deceived doctors and patients and patients are not aware of or do of long-term opioid use. Studies also reveal that many doctors often report that they were not warned not understand these risks and benefits. Indeed, patients As reported in January 2016, a 2015 they might become addicted to opioids prescribed to them. 4 out of 10 were not told opioids were survey of more than 1,000 opioid patients found that

potentially addictive.34

at: Questions, Missed Opportunities (Jan. 27, 2016), available 34 Hazelden Betty Ford Foundation, Missed http://www.hazeldenbettyford.org/about-us/news-and-media/pressrelease/doetors-missinu-questions-that-could- prevent-opioid-addiction.

#8.40 Page 41 of 57 East Baton Rouge Parish Clerk of Court

124.

and continues to cause doctors in Defendants' deceptive marketing scheme caused conditions such as back pain, headaches, Louisiana to prescribe opioids for chronic pain deceptive marketing scheme, these doctors arthritis, and fibromyalgia. Absent Defendants' Defendants' deceptive marketing scheme also would not have prescribed as many opioids. and use opioids for their chronic pain caused and continues to cause patients to purchase Defendants' deceptive marketing scheme, fewer believing they are safe and effective. Absent chronic pain, and those patients using opioids patients would be using opioids long-term to treat

would be using less of them. 125.

to cause the prescribing and Defendants' deceptive marketing has caused and continues increase in opioid prescriptions and use use of opioids to explode. Indeed, this dramatic spending on their deceptive marketing corresponds with the dramatic increase in Defendants' approximately $91 million in 2000. scheme. Defendants' spending on opioid marketing totaled

By 2011, that spending dramatically increased to X288 million. 126.

who were deceived by The escalating number of opioid prescriptions written by doctors dramatic increase in Defendants' deceptive marketing scheme is the cause of a correspondingly States and Louisiana. In August opioid addiction, overdose, and death throughout the United an open letter to be sent to 2016, then-U.S. Surgeon General Vivek Murthy published health crisis" and linking physicians nationwide, enlisting their help in combating this "urgent to treat pain, and that crisis to deceptive marketing. There, he wrote that the push aggressively marketing to doctors . . . the "devastating" results that followed, had "coincided with heavy are not addictive when [m]any of [whom] were even taught — incorrectly — that opioids

prescribed for legitimate pain." 127.

prescriptions and Scientific evidence demonstrates a strong correlation between opioid pain reliever prescribing has opioid abuse. In a 2016 report, the CDC explained that "[o]pioid overdoses." Patients receiving quadrupled since 1999 and has increased in parallel with [opioid] overdoses. For these reasons, prescription opioids for chronic pain account for the majority of

#8.41 Page 42 of 57 East Baton Rouge Parish Clerk of Court

of opioids for chronic pain are critical the CDC concluded that efforts to rein in the prescribing and prevent opioid-related morbidity." "to reverse the epidemic of opioid drug overdose deaths 128.

addiction begins with legitimately Contrary to Defendants' misrepresentations, most opioid had Defendants' representations to prescribed opioids, and therefore could have been prevented abused prescription opioids got them prescribers been truthful. In 2011, 71% of people who or the internet.35 Numerous doctors through friends or relatives, not from "pill mills," drug dealers patients who misuse or abuse opioids and substance abuse counselors note that many of their important role that doctors' prescribing started with legitimate prescriptions, confirming the

habits have played in the opioid epidemic. 129.

through false and deceptive Defendants' creation of a virtually limitless opioid market, harmed LDH and communities advertising and other unlawful and unfair conduct, significantly market for opioids to new patients throughout Louisiana. Defendants' success in extending the for non-medical and criminal and chronic pain conditions created an abundance of drugs available suggest that 60% of the opioids that use and fueled a new wave of addiction and injury. Estimates 36 are abused come, directly or indirectly, through doctors' prescriptions. 130.

drug abuse with Law enforcement agencies have increasingly associated prescription of prescription drugs, local law violent and property crimes. Despite strict federal regulation legitimate sources for illicit enforcement agencies are faced with increasing diversion from pharmacy records, and purposes, including: doctor shopping, forged prescriptions, falsified epidemic has prompted a employees who steal from their place of employment. The opioid and burglary. In fact, a 2005 growing trend of crimes against pharmacies including robbery University revealed that, study by The Center on Addiction and Substance Abuse at Columbia certain medications such by that time, 20.9% of pharmacies nationwide had stopped stocking from robbery. This ongoing as OxyContin and Percocet, in order to protect themselves

diversion of prescription narcotics creates a lucrative marketplace.

Survey on Drug Use and Health (Sept. 2012). 35 See U.S. Dep't of Health & Human Servs., 2011 National and Opportunities for Payers, Am. J. Managed Care 36 Nathaniel P. Katz, Prescription Opioid Abuse: Challenges is, directly or indirectly, by prescription."), (Apr. 19 2013), at 5 ("The most common source of abused [opioids] 1 available at http://www.aimc.com/oublications/issue/2013/2013-1-vol 9-n4/Prescription-Ooioid-Abuse-Challenges- and-Opportunities-for-Payers

#8.42 Page 43 of 57 East Baton Rouge Parish Clerk of Court

131.

are staggering. Prescription opioid misuse, The costs and consequences of opioid addiction well as on the health and safety of individuals as abuse and overdose have an enormous impact who is of this epidemic reach far beyond the individual communities at large, as the consequences include job loss, loss of custody of children, addicted. Some of the repercussions for individuals and incarceration.37 physical and mental health problems, homelessness 132.

about these harms that their wrongful conduct Defendants knew and should have known Their sales sales and the habits of prescribing doctors. caused. Defendants closely monitored their their CMEs, knew which doctors were receiving representatives, who visited doctors and attended Defendants also had access to and monitored messages and how they were responding. and explosive rise in opioid use, addiction, injury, government and other data that tracked the prescribe misrepresentations would persuade doctors to death. They knew and intended that their pain. and patients to use their opioids for chronic 133.

excused by the fact that their drug labels (with Defendants' actions are not permitted nor have allowed or did not exclude the use of opioids the exception of the Actiq/Fentora labels) may to for certain uses did not allow Defendants for chronic pain. FDA approval of opioids Indeed, Defendants' misrepresentations were misrepresent the risks and benefits of opioids. guidance from the FDA based on the medical directly contrary to pronouncements by and

evidence and their own labels. 134.

involvement of doctors. Defendants' Nor is Defendants' causal role broken by the persuasive. Their deceptive messages tainted marketing efforts were ubiquitous and highly information and prevented them from making virtually every source doctors could rely on for able to harness and hijack what doctors informed treatment decisions. Defendants were also a means of relieving their patients' wanted to believe — namely, that opioids represented Defendants touted their products as suffering and of practicing medicine more compassionately. to believe that they were giving patients medical breakthrough and preyed upon doctors wanting

the most modem and safe care available.

37 See Section I.

#8.43 Page 44 of 57 East Baton Rouge Parish Clerk of Court

135.

the Louisiana Department of Health incurred As referenced above, from 2007 to present, treatment of opioid use and dependence. approximate costs totaling $677,254,416 for 136.

toll on the Louisiana Department of While the use of opioids has taken an enormous as further detailed in Section I. Health, Defendants made blockbuster profits V. CAUSES OF ACTION

137.

declines and does not assert any The Louisiana Department of Health specifically Defendants' actions. federal law cause of action with respect to the Programs Integrity Law Violations of Louisiana Medical Assistance ("MAPIL")

138.

article 853, the Louisiana Department of Pursuant to Louisiana Code of Civil Procedure fully set allegations in the preceding paragraphs as if Health incorporates by reference all previous

forth herein. 139.

46:438.3 and other laws which allow This action is brought pursuant to La. Rev. Statute damages, penalties, interest, attorney fees, and the Louisiana Department of Health to recover of false and fraudulent claims to the medical costs for the conduct resulting in the submission the following acts, among others, in violation assistance programs. Defendants have engaged in

of Section 438.3: or fraudulent claims to be presented and a. knowingly presenting or causing false unlawfully marketing opioids as submitted to the medical assistance programs by detailed herein; related to the safety and efficacy of b. knowingly engaging in misrepresentations to obtain payment from medical opioids as part of an attempt to obtain and assistance programs funds as detailed herein; causing false claim submissions for c. as part of sophisticated scheme knowingly prescription drugs with the intent reimbursement to be filed for highly addictive drugs causing more false claims to that the addicted patients will use more of the be filed; the medical assistance programs d. conspiring to defraud, or attempting to defraud, opioids as detailed herein; and through misrepresenting the safety and efficacy of from medical assistance programs for e. obtaining, or attempting to obtain, payment false or fraudulent claims as detailed herein.

#8.44 Page 45 of 57 East Baton Rouge Parish Clerk of Court

140.

actual damages resulting from the The Louisiana Department of Health's alleged Each violation of this Section is considered foregoing acts are in excess of one thousand dollars.

a separate violation. 141.

to collect actual damages for monies paid The Louisiana Department of Health is entitled in defendants promoted, marketed, and sold opioids that would otherwise not have been paid had Additionally, the Louisiana Department of compliance with the law. (LSA-R.S. 46:438.6(A)). in LSA-R.S. 46:438.6(B). Additionally, the Health is entitled to the civil fine described civil penalties under LSA-R.S. 46:438.6(C). Louisiana Department of Health is entitled to the entitled to an award of costs, expenses, fees, Additionally, the Louisiana Department of Health is

interest, and attorney fees as set forth in LSA-R.S. 46:438.6(D).

Violations of Louisiana Racketeering Act (LSA-R.S. 15:1351 et seq.)

142.

(collectively, "Racketeering Defendants Purdue, Janseen, Cephalon, and Endo obtained by false pretenses a thing of Defendants") unlawfully misappropriated, converted, and to include Medicaid payments value (property) belonging to the Louisiana Department of Health for chronic pain. Accordingly, made for medically unnecessary opioids prescribed and dispensed of LSA-R.S. § 14:67(A), to the Racketeering Defendants' actions constitute theft in violation belongs to another, either without wit: the misappropriation or taking of anything of value which means of fraudulent conduct, the consent of the other to the misappropriation or taking, or by conspired with others known practices, or representations. Also, the Racketeering Defendants pretenses, and attempted to and unknown to misappropriate, convert, and obtain by false rightfully belonging to the misappropriate, convert, and obtain by false pretenses the money held and administered by the Louisiana Department of Health in the form of Medicaid funding Defendants' actions constitute Louisiana Department of Health. Accordingly, the Racketeering Defendants' actions also conspiracy to commit theft, theft and attempted theft. The Racketeering as conspiracy and attempt constitute Medicaid fraud in violation of LSA-R.S. § 14:70.1 as well

to commit Medicaid fraud in violation of state law.

#8.45 Page 46 of 57 East Baton Rouge Parish Clerk of Court

143.

committed various fraudulent acts which As detailed above, the Racketeering Defendants intentional omissions of material fact and constitute fraud and a scheme to defraud. These Defendants were false when made which affirmative representations made by the Racketeering and the following acts: included but was not limited to the acts detailed above Defendants' opioids, and their a. Marketing materials about the Racketeering sent to health care risks and benefits, which the Racketeering Defendants Louisiana; i providers located across the country and i the Racketeering Written representations and telephone calls between b. about the Defendants and Front Groups regarding representations for chronic pain i Racketeering Defendants' opioids, or the use of opioids t generally; between the Racketeering c. Written representations and telephone calls or the use of Defendants and KOLs regarding Defendants' opioids, opioids for chronic pain generally; Defendants and the Front d. Hundreds of e-mails between the Racketeering of the opioid Groups agreeing to or effectuating the implementation marketing scheme; Defendants and KOLs e. Hundreds of e-mails between the Racketeering opioid marketing agreeing to or effectuating the implementation of the scheme; Groups and publications, f. Hundreds of communications between the Front effectuating the groups drafting treatment guidelines and the media implementation of the opioid marketing scheme; groups Hundreds of communications between the KOLs and publications, g. effectuating the drafting treatment guidelines and the media implementation of the opioid marketing scheme; agencies and private h. Written and oral communications directed to State the risks of insurers throughout Louisiana that fraudulently misrepresented benefits of using opioids for chronic pain; and proceeds of Receipts of increased profits which represented the wrongful the scheme.

144.

commit theft, attempted theft, The Racketeering Defendants' theft, conspiracy to Medicaid fraud, and attempted misappropriation, fraud, Medicaid fraud, conspiracy to commit Department of Health's damages Medicaid fraud were each the proximate cause of the Louisiana the execution of the Racketeering as detailed herein. These violations occurred through and affirmative misrepresentation to Defendants' scheme using omissions of material fact fraud, Medicaid fraud, conspiracy to perpetrate the theft, attempted theft, misappropriation, the Louisiana Department of Health commit Medicaid fraud, and attempted Medicaid fraud upon

#8.46 Page 47 of 57 East Baton Rouge Parish Clerk of Court

payments by the Louisiana Department of Health to include the numerous unjustified Medicaid

for the ultimate benefit of the Racketeering Defendants. 145.

of the Louisiana Racketeering Act In addition, these fraudulent acts are all in violation of Health specifically declines and (LSA-R.S. §§ 15:1351 et seq.). The Louisiana Department action with respect to the Racketeering does not assert any federal law cause of

Defendants' actions. 146.

for the Racketeering Defendants' The Louisiana Department of Health seeks damages misappropriation, fraud, Medicaid fraud, theft, conspiracy to commit theft, attempted theft, fraud, scheme to defraud, and conspiracy to commit Medicaid fraud, and attempted Medicaid without limitation all damages, fees, fraudulent conduct, practices, and representations including Racketeering Defendants' actions, which and costs it has incurred or will incur as a result of the

must be trebled under LSA-R.S. § 15:1356(E). 147.

fees and litigation and The Louisiana Department of Health also seeks attorney's § 15:1356(E). investigative costs incurred in this matter pursuant to LSA-R.S. 148.

Defendants named The "Opioid Marketing Enterprise" consisted of the Racketeering detailed above, KOLs detailed herein, the remaining Defendants named herein, the Front Groups of entities associated with the above, and others to include but not limited to employees existed as an "enterprise" as Racketeering Defendants. Further, the Opioid Marketing Enterprise

defined in LS A-R.S. § 15:1352(B). 149.

in fact and included unlawful The Opioid Marketing Enterprise existed as an association

as well as lawful enterprises as defined in LSA-R.S. § 15:1352(B). 150.

Marketing Enterprise, the While the Racketeering Defendants participated in the Opioid from the Opioid Marketing Racketeering Defendants also existed separate and distinct

Enterprise.

#8.47 East Baton Rouge Parish Clerk of Court Page 48 of 57

151.

the Opioid Marketing The Racketeering Defendants maintained an interest and control of conduct of the Opioid Marketing Enterprise and also conducted and participated in the

Enterprise's affairs through a pattern of racketeering activity. 152. the Opioid Marketing The Racketeering Defendants' control and participation in Racketeering Defendants Enterprise were necessary for the successful activity in which the the following acts: engaged that included but was not limited to the acts detailed above and

a. the Racketeering Defendants created a body of deceptive and unsupported medical and popular literature about opioids that: (a) understated the risks and overstated the benefits of long-term use; (b) appeared to be the result of independent, objective research; and (c) was thus more likely to be relied upon by physicians, patients, and payors;

b. the Racketeering Defendants selected, cultivated, promoted, and paid the KOLs based solely on their willingness to communicate and distribute Defendants' messages about the use of opioids for chronic pain; t t c. the Racketeering Defendants provided substantial opportunities for KOLs to participate in research studies on topics Defendants suggested or chose, 4 with the predictable effect of ensuring that many favorable studies i appeared in the academic literature; i

d. the Racketeering Defendants paid KOLs to serve as consultants or on their advisory boards and to give talks or present CMEs, typically over meals or at conferences;

e. the Racketeering Defendants disseminated many of their false, misleading, imbalanced, and unsupported statements through unbranded materials that appeared to be independent publications from Front Groups;

f. the Racketeering Defendants sponsored CME programs put on by Front Groups that focused exclusively on the use of opioids for chronic pain;

the Racketeering Defendants developed and disseminated pro-opioid treatment guidelines;

h. the Racketeering Defendants encouraged Front Groups to disseminate their pro-opioid messages to groups targeted by Defendants, such as veterans and the elderly, and then funded that distribution;

the Racketeering Defendants concealed their relationship to and control of Front Groups and KOLs from the Louisiana Department of Health and the public at large; and

the Racketeering Defendants intended that Front Groups and KOLs would distribute promotional and other materials that claimed opioids could be safely used for chronic pain.

153.

The Front Groups also participated in the conduct of the affairs of the Opioid Marketing

Enterprise, directly or indirectly, in the following ways:

#8.48 Page 49 of 57 East Baton Rouge Parish Clerk of Court

make representations regarding a. The Front Groups promised to, and did, Defendants' messages Defendants' opioids that were consistent with themselves; and other materials which b. The Front Groups distributed promotional pain, and the benefits claimed that opioids could be safely used for chronic and of using opioids for chronic pain outweighed the risks; to Defendants. c. The Front Groups concealed their connections

154.

of the Opioid Marketing The KOLs also participated in the conduct of the affairs

Enterprise, directly or indirectly, in the following ways: representations regarding a. The KOLs promised to, and did, make messages Defendants' opioids that were consistent with Defendants' themselves; which claimed that b. The KOLs distributed promotional and other materials of using opioids could' be safely used for chronic pain, and the benefits opioids for chronic pain outweighed the risks; and Defendants. c. The KOLs concealed their connections to and sponsorship by

155.

and apart from The Opioid Marketing Enterprise had an ascertainable structure separate

the pattern of racketeering activity in which the Racketeering Defendants engaged.

156.

Enterprise The Racketeering Defendants and the other members of the Opioid Marketing fact Opioid Marketing shared in the fruits of its predicate acts detailed above. The association in Marketing Enterprise Enterprise, the Racketeering Defendants, and other members of the Opioid pursuing a course of had a formal, ongoing relationship that functioned as a continuing unit, of structure and conduct as set forth above, with a common or shared purpose, and continuity

personnel. 157.

the Opioid The Racketeering Defendants and those employed by or associated with through a pattern Marketing Enterprise conducted the affairs of the Opioid Marketing Enterprise to violate of racketeering activity in violation of LSA-R.S. § 15:1353(C) and have conspired

Section 15:1353(C) in violation of Section 15:1353(D) as detailed above.

158. Opioid The Racketeering Defendants and those employed by or associated with the intentionally, Marketing Enterprise violated Section 15:1353(D), inasmuch as they knowingly,

#8.49 East Baton Rouge Parish Clerk of Court Page 50 of 57

Enterprise and conspired and unlawfully aided and abetted each other and the Opioid Marketing affairs of the Enterprise, to conduct and participate, directly or indirectly, in the conduct of the

through the pattern of racketeering activity described herein.

159. Marketing With respect to the activities alleged and detailed herein, the Opioid to violate La. R.S. § Enterprise sought to aid and abet and actually did aid and abet a transaction commit theft), § 15:1353(C) and specifically LSA-R.S. § 14:67 (theft), § 14:26 (conspiracy to to commit 14:27 (attempted theft), LSA-RS. § 14:70.1 (Medicaid fraud), § 14:26 (conspiracy

Medicaid fraud), and § 14:27 (attempted Medicaid fraud).

160.

The Opioid Marketing Enterprise's scheme to defraud resulted in severe financial losses

to the Louisiana Department of Health.

161.

The Opioid Marketing Enterprise's misrepresentations constitute tortious and illegal acts

as defined by Louisiana law including but not limited to violations of LSA-R.S. § 14:67 (theft), §

14:26 (conspiracy to commit theft), § 14:27 (attempted theft), LSA-R.S. § 14:70.1 (Medicaid

fraud), § 14:26 (conspiracy to commit Medicaid fraud), and § 14:27 (attempted Medicaid fraud).

162.

The violations set forth herein constitute "racketeering activity" within the meaning of

LSA-R.S. § 15:1353, by the members of the Opioid Marketing Enterprise committing,

conspiring to commit, and/or attempting to commit the Title 14 offenses alleged herein with at

least two such acts of racketeering activity, as described herein, having occurred within the past

five years.

163.

The Opioid Marketing Enterprise's racketeering activities or predicate acts are related

and also amount to continuing criminal activity which occurred over an extended period of time.

164.

As a result of the actions undertaken by the Opioid Marketing Enterprise, the Louisiana

Department of Health is entitled to recover pursuant to LSA-R.S. § 15:1353(E) three times the actual damages sustained, attorney fees in the trial and appellate courts and costs of investigation 1 and litigation reasonably incurred.

#8.50 Page 51 of 57 East Baton Rouge Parish Clerk of Court

Fraud

165.

Louisiana Department of Pursuant to Louisiana Code of Civil Procedure article 853, the preceding paragraphs as if fully set Health incorporates by reference all previous allegations in the

forth herein. 166.

herein. Defendants made numerous fraudulent misrepresentations as detailed

167.

committing fraud Defendants engaged in repeated fraudulent acts and practices, thus Code article 2315 (as against the Louisiana Department of Health, pursuant to Louisiana Civil of Health specifically defined in Louisiana Civil Code article 1953). The Louisiana Department Department of declines and does not assert any contractual fraud claim; instead, the Louisiana

Health asserts only a delictual fraud claim under this cause of action.

Negligent Misrepresentation

168.

of Pursuant to Louisiana Code of Civil Procedure article 853, the Louisiana Department as if fully set Health incorporates by reference all previous allegations in the preceding paragraphs

forth herein.

169.

to the For reasons set forth above, Defendants made negligent misrepresentations 2315 and Louisiana Department of Health and others pursuant to Louisiana Civil Code articles of Health 2316. There existed at all relevant times a legal duty owed to the Louisiana Department analgesic pain by the Defendants to accurately warn of the efficacy and side effects of opioid of Health relievers. Defendants breached this duty as set forth above. The Louisiana Department result of reasonably relied upon Defendants' representations. As an actual and proximate reliance Defendants' misrepresentations, and the Louisiana Department of Health's reasonable

thereof, the Louisiana Department of Health has been damaged as detailed above.

170,

for The Louisiana Department of Health is entitled to judgment against Defendants of restitution, attorney's fees and costs for the losses incurred by the Louisiana Department

Health as a direct and proximate cause of Defendants' misrepresentations.

#8.51 East Baton Rouge Parish Clerk of Court Page 52 of 57

Redhibition

171.

853, the Louisiana Department of Pursuant to Louisiana Code of Civil Procedure article in the preceding paragraphs as if fully set Health incorporates by reference all previous allegations

forth herein. 172.

the manufacture, marketing, and Pursuant to Louisiana Civil Code 2520, et seq., through Butrans, Hysingla ER, and Targiniq ER, sale of OxyContin, MS Contin, Dilaudid/Dilaudid HP, Percodan, Zydone, Kadian, oxycodone, Percocet, Actiq, Fentora, Duragesic, Opana/Opana ER, Department of Health, hydrocodone and Norco, Defendants warranted to the Louisiana payors that OxyContin, MS Louisiana patients, medical assistance programs and government ER, Percocet, Actiq, Contin, Dilaudid/Dilaudid HP, Butrans, Hysingla ER, and Targiniq hydrocodone and Fentora, Duragesic, Opana/Opana ER, Percodan, Zydone, Kadian, oxycodone,

Norco were free of any redhibitory effects.

173.

By virtue of the acts alleged above, Defendants had reason to know that the Louisiana public Department of Health, patients, their insurers, public health care providers, prescribers,

entities, medical assistance programs and government payors were purchasing and using ER, OxyContin, MS Contin, Dilaudid/Dilaudid HP, Butrans, Hysingla ER, and Targiniq

Percocet, Actiq, Fentora, Duragesic, Opana/Opana ER, Percodan, Zydone, Kadian, oxycodone,

hydrocodone and Norco for the treatment of unapproved indications or for ineffective treatment.

Therefore, pursuant to La, C.C. art. 2520, Defendants warranted to the Louisiana Department of

Health, Louisiana patients, their insurers, public health care providers, prescribers, public

entities, medical assistance programs and government payors that OxyContin, MS Contin,

Dilaudid/Dilaudid HP, Butrans, Hysingla ER, and Targiniq ER, Percocet, Actiq, Fentora,

Duragesic, Opana/Opana ER, Percodan, Zydone, Kadian, oxycodone, hydrocodone and Norco

were for those particular purposes.

174.

OxyContin, MS Contin, Dilaudid/Dilaudid HP, Butrans, Hysingla ER, and Targiniq ER,

Percocet, Actiq, Fentora, Duragesic, Opana/Opana ER, Percodan, Zydone, Kadian, oxycodone,

hydrocodone and Norco contain redhibitory defects unknown and undiscoverable to the

#8.52 East Baton Rouge Parish Clerk of Court Page 53 of 57

false representations and omissions Louisiana Department of Health, but for Defendants' MS Contin, Dilaudid/Dilaudid HP, regarding unapproved indications and uses for OxyContin, Duragesic, Opana/Opana ER, Butrans, Hysingla ER, and Targiniq ER, Percocet, Actiq, Fentora, Norco, Louisiana healthcare Percodan, Zydone, Kadian, oxycodone, hydrodone and Dilaudid/Dilaudid HP, professionals would not have prescribed OxyContin, MS Contin, Duragesic, Opana/Opana ER, Butrans, Hysingla ER, and Targiniq ER, Percocet, Actiq, Fentora, unapproved indications Percodan, Zydone, Kadian, oxycodone, hydrodone and Norco for such have purchased and uses, and consequently, the Louisiana Department of Health would not ER, and and/or paid for OxyContin, MS Contin, Dilaudid/Dilaudid HP, Butrans, Hysingla Kadian, Targiniq ER, Percocet, Actiq, Fentora, Duragesic, Opana/Opana ER, Percodan, Zydone,

oxycodone, hydrodone and Norco.

175.

The redhibitory defects existed at the time OxyContin, MS Contin, Dilaudid/Dilaudid

HP, Butrans, Hysingla ER, and Targiniq ER, Percocet, Actiq, Fentora, Duragesic, Opana/Opana

ER, Percodan, Zydone, Kadian, oxycodone, hydrodone and Norco were purchased and/or paid

for by the Louisiana Department of Health, and the Louisiana Department of Health had no

knowledge of the redhibitory defects when it paid for OxyContin, MS Contin, Dilaudid/Dilaudid

HP, Butrans, Hysingla ER, and Targiniq ER, Percocet, Actiq, Fentora, Duragesic, Opana/Opana

ER, Percodan, Zydone, Kadian, oxycodone, hydrodone and Norco and it could not have

reasonably discovered the hidden redhibitory defects in OxyContin, MS Contin,

Dilaudid/Dilaudid HP, Butrans, Hysingla ER, and Targiniq ER, Percocet, Actiq, Fentora,

Duragesic, Opana/Opana ER, Percodan, Zydone, Kadian, oxycodone, hydrodone and Norco.

176.

Defendants breached their warranty of redhibition and as a direct result of this breach of

warranty, the Louisiana Department of Health has suffered and will continue to suffer damages.

177.

Pursuant to La. C.C. art. 2545, Defendants are liable to the Louisiana Department of

Health for the return of the price with interest from the time it was paid for, reimbursement of the

reasonable expenses occasioned by the sale, and for damages, including any consequential

damages for medical care and expenses related to the undisclosed adverse effects and side effects

of OxyContin, MS Contin, Dilaudid/Dilaudid HP, Butrans, Hysingla ER, and Targiniq ER,

#8.53 East Baton Rouge Parish Clerk of Court Page 54 of 57

Percodan, Zydone, Kadian, oxycodone, Percocet, Actiq, Fentora, Duragesic, Opana/Opana ER, trial, as well as reasonable attorney hydrodone and Norco in a total amount to be determined at

fees to be set by the Court. Unjust Enrichment

178.

the Louisiana Department of Pursuant to Louisiana Code of Civil Procedure article 853, preceding paragraphs as if fully set Health incorporates by reference all previous allegations in the

forth herein. 179.

recoveries for Alternatively, the Louisiana Department of Health asserts that by receiving Louisiana Medicaid, overpayments/overcharges for prescriptions which were reimbursed by Department of Defendants have been enriched without cause at the expense of the Louisiana restore to Health. Pursuant to Louisiana Civil Code article 2298, Defendants are obligated to

Louisiana Department of Health the portion of any payments for OxyContin, MS Contin,

Dilaudid/Dilaudid HP, Butrans, Hysingla ER, and Targiniq ER, Percocet, Actiq, Fentora,

Duragesic, Opana/Opana ER, Percodan, Zydone, Kadian, oxycodone, hydrodone and Norco,

opioid analgesic pain relievers. attributable to prescriptions reimbursed by Louisiana Medicaid.

180.

It would be inequitable for Defendants to be permitted to retain any of the overcharges

for OxyContin, MS Contin, Dilaudid/Dilaudid HP, Butrans, Hysingla ER, and Targiniq ER,

Percocet, Actiq, Fentora, Duragesic, Opana/Opana ER, Percodan, Zydone, Kadian, oxycodone,

hydrodone and Norco, opioid analgesic pain relievers, derived from Defendants' unfair and

unconscionable methods, acts and trade practices alleged in this Petition.

181.

Defendants should be compelled to disgorge for the benefit of Plaintiff all unlawful or

inequitable proceeds received by Defendants.

182.

Plaintiff has no adequate remedy at law.

#8.54 East Baton Rouge Parish Clerk of Court Page 55 of 57

183.

La. C.C. art. 2298, Defendants The Louisiana Department of Health alleges that under to an award for costs, expenses, fees, have been unjustly enriched and, thus, Plaintiff is entitled

and attorney fees.

VI. PRAYER FOR RELIEF Petition for Damages WHEREFORE, the Louisiana Department of Health prays that its that, after due proceedings are had and Injunctive Relief be deemed good and sufficient and each and every Defendant, hereon, judgment be rendered in the Plaintiff's favor and against indebted to the Louisiana jointly severally and in solido, finding these Defendants liable and

Department of Health for: and against a. for judgement in favor of the Louisiana Department of Health Defendants under Louisiana's Medical Assistance Programs Integrity Law, LSA- of R.S. § 46:438.6 for actual damages incurred by the Louisiana Department Health as a result of Defendants' violations of Section 46:438.6, a civil fine in the amount of three times the Louisiana Department of Health's actual damages sustained as a result of Defendants' violations of Section 46:438.6, and interest at the maximum rate of legal interest provided by LSA-R.S. § 13:4202 from the date the violations occurred to the date of repayment, in a total amount to be determined at trial;

b. for judgment in favor• of the Louisiana Department of Health and against Defendants, under Louisiana's Medical Assistance Programs Integrity Law, LSA- R.S. § 46:438.6 for actual damages incurred by the Louisiana Department of Health as a result of Defendants' violations of Section 46:438.6, a civil monetary penalty of eleven thousand dollars ($11,000.00) for each violation, and interest at the maximum rate of legal interest provided by LSA-R.S. § 13:4202 from the date the violations occurred to the date of repayment;

c. for judgment in favor of the Louisiana Department of Health and against Defendants, under Louisiana's Medical Assistance Programs Integrity Law, LSA- R.S. § 46:438.6(D) for all costs, expenses and fees related to investigations and proceedings associated with the violations alleged herein, including attorney fees;

d. for judgment in favor of the Louisiana Department of Health against the Racketeering Defendants for actual damages in an amount to be proven at trial, plus treble damages, attorney fees, interests, and costs as provided by La. R.S. § 15:1353(E);

e. for judgment in favor of the Louisiana Department of Health and against Defendants, under Louisiana's Fraud laws, for actual damages, restitution, disgorgement, and attorney fees and costs;

for judgment favor of the Louisiana Department of Health and against Defendants, under Louisiana's Redhibition law, La C.C. art. 2545, for restitution and judicial interest, as well as for reimbursement of reasonable expenses occasioned by the sale, and for damages and reasonable attorney fees and costs;

g. for judgment in favor of the Louisiana Department of Health and against Defendants, under Louisiana's Negligent Misrepresentation laws, for damages, reasonable attorney fees, and costs;

#8.55 East Baton Rouge Parish Clerk of Court Page 56 of 57

and against h. for judgment in favor of the Louisiana Department of Health Defendants, under La. C.C. art. 2298, that Defendants have been unjustly enriched and are liable to the Louisiana Department of Health for compensation to the extent that Defendants have been unjustly enriched, for costs, expenses, fees, and attorney fees; such amount i. for all damages sustained by the Louisiana Department of Health in as is proven at trial, together with prejudgment interest;

injunctive relief enjoining Defendants from, directly or indirectly through KOLs, Front Groups or other third parties, continuing to misrepresent the risks and benefits of the use of opioids for chronic pain, and from continuing to violate Louisiana law; and

k. judicial interest from the date of the judicial demand; and deems 1. such other and further legal, general, and equitable relief that the Court necessary, justified, and proper under the circumstances of this matter. herein be Finally, the Louisiana Department of Health demands that the claims asserted

adjudicated by jury trial. By Attorneys:

STEPH N R. RUSSO (Bar Roll 23284) Executive Counsel Louisiana Department of Health Post Office Box 629 Baton Rouge, LA 70821-0629 (225) 342-1115 / stephen.russolalla.gov Counsel for Plaintiff THE LOUISIANA DEPARTMENT OF HEALTH, THROUGH THE SECRETARY OF THE LOUISIANA DEPARTMENT OF HEALTH

PLEASE HOLD SERVICE:

PURDUE PHARMA L.P. Through the Long Arm Statute

PURDUE PHARMA, INC. Through the Long Arm Statute

THE PURDUE FREDERICK COMPANY, INC. Through the Long Arm Statute

TEVA PHARMACEUTICAL INDUSTRIES, LTD. Through the Long Arm Statute '• OL-uAMAGEY rzi TEVA PHARMACEUTICALS USA, INC. 02-CONTRAGI SERV, COMa. Through the Long Arm Statute n fM•r,Iso':.,. • !Luf 0ER AtaJTinii:: ❑ 04-EY.F.0 CEPHALON, INC. Through the Long Arm Statute C5-EV:

JOHNSON & JOHNSON ❑ O'd-JUDIGUL n!2- Through the Long Arm Statute ❑ C9 PROPERTY RIGHTS r] 1S- le-INJUNCTION MANDAMUS 20.

#8.56 East Baton Rouge Parish Clerk of Court Page 57 of 57

JANSEEN PHARMACEUTICALS, INC. Through the Long Arm Statute

ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC. n/kJa JANSSEN PHARMACEUTICALS, INC, Through the Long Arm Statute

ENDO HEALTH SOLUTIONS INC. Through the Long Arm Statute

ENDO PHARMACEUTICALS, INC. Through the Long Arm Statute

ALLEGRAN PLC f/k/a ACTAVIS PLC Through the Long Arm Statute

WATSON PHARMACEUTICALS, INC. n/k/a ACTAVIS, INC. Through the Long Arm Statute

WATSON LABORATORIES, INC. Through the Long Arm Statute

ACTAVIS LLC Through the Long Arm Statute

ACTAVIS PHARMA, INC. f/k/a WATSON PHARMA, INC. Through the Long Arm Statute

#8.57