D r u g a n d M e d ical Device Agency vs. Class Action in Advertising Litigation Regulatory Compliance

By Laurie Webb Daniel Defenses

Uniform standards Plaintiffs’ lawyers usually like to piggyback on agency in regulation are at action. They have been doing it for years in the securities, risk from piggyback antitrust, and product liability arenas. Not satisfied with litigation. traditional causes of action, creative lawyers recently have blended legal theories under the gen- The Advertising Watchdogs: eral rubric of consumer protection law in Official and Self-Proclaimed an attempt to recover staggering amounts The Food and Drug Administration even where no injury can be shown. They (“FDA”) is the official advertising watchdog have chosen a big target: prescription drug for the pharmaceutical industry. Although labeling and marketing practices. Ironi- the Federal Trade Commission (“FTC”) is cally, however, governmental regulation of tasked with preventing deceptive advertis- consumer communication in this industry ing for other health care products, see 15 is turning out to be an excellent platform U.S.C. §52, it is the FDA that must determine for defense instead of the free ride expected whether prescription drug labeling is “false by the plaintiffs’ bar. or misleading.” See 21 U.S.C. §355(b)(1); 21 As plaintiffs’ lawyers dip into their melt- C.F.R. §314.125(b)(6). Through its Center ing pot of theories, the industry can turn to for Drug Evaluation and Research (CDER), traditional but evolving legal principles to the FDA also oversees advertising, market- keep consumer litigation in line with sound ing, and promotional materials relating to social policy. This article analyzes several prescription drugs. See 21 U.S.C. §352(n); defenses grounded in the common sense see also id., §§321(n), 331(a), 352(a); 21 notion that it is the job of the Food and C.F.R. §§202.1(e)(4)(i)(a); 314.81(b)(3)(i). Drug Administration, not lay tribunals, to It is CDER’s responsibility “to assure that make sure that pharmaceutical information prescription drug information provided is accurate and not misleading. The article by drug firms is truthful, balanced, and then discusses how to lay the groundwork accurately communicated.” See http://www. for shaping these defenses in future appel- fda.gov/cder/handbook/advertis.htm (last vis- late decisions in drug advertising cases. ited 3/10/2006). CEDR accomplishes this through a comprehensive surveillance, enforcement, and education program. n Laurie Webb Daniel leads the Appellate Team of Holland & Knight LLP. Id. CDER’s “Division of Drug Marketing, Her practice focuses on complex litigation involving business, competition, Advertising, and Communications” or and medical liability issues. Based in Atlanta, she has appeared in courts “DDMAC” pays particularly close attention nationwide, including the United States Supreme Court. Ms. Daniel is a fre- to advertising through internet and other quent commentator for DRI and other organizations. “direct-to-consumer” or “DTC” channels.

20 n For The Defense n April 2006 © 2006 DRI. All rights reserved. See http://www.fda.gov/cder/handbook/pol_guid. In addition to the federal regulators and sory Committee on the Federal Rules of htm (last visited 3/10/2006). PhRMA, there are others who claim to pro- Civil Procedure in connection with the The FDA’s supervision of drug advertis- tect the public from inaccurate medical addition of Rule 23(f) to permit discre- ing is not a rubber stamp process. There is information. These are the champions of tionary appeals of class certification orders, scrutiny by various professionals, includ- state consumer fraud and unfair competi- class actions often raise the specter of unde- ing social scientists and regulatory coun- tion statutes—the state attorneys general served “potentially ruinous liability.” The sel. See Direct to Consumer Advertising of and the plaintiffs’ bar. While the attor- high costs and risks of class action litiga- Prescription Drugs: Exploring the Conse- neys general act in an official capacity as tion can impact the availability of drugs and quences: Hearing before the Senate Spe- parens patriae for the benefit of the pub- other medical products just as regulation by cial Comm. on Aging, 108th Cong. (2003), lic, the private lawyers are self-designated available at 2003 WL 56336398. The agency prosecutors who stand to reap tremen- provides specific guidance to drug com- dous personal profit if they can survive the panies that submit proposed advertising. dispositive motion and class certification The FDA has the ability Id. When the FDA determines that adver- stages of their litigation. The highly moti- tising is misleading, it issues warning let- vated plaintiffs’ bar does not suffer from a to consider the views of ters, which are posted on the FDA website. lack of creativity. When they cannot prove See http://www.fda.gov/cder/warn/ (last visited actual injury from pharmaceutical infor- the public at large, as 3/10/2006). The FDA website notes that the mation, they try to imbue consumer pro- warning letters can result in subsequent tection statutes with presumptions from well as scientists and interaction between the FDA and the recip- securities fraud and other areas of the ient of the letter, and the letters themselves law. See, e.g., New Jersey Citizen Action v. industry participants. reflect the agency’s insistence on correc- Schering-Plough Corp., 842 A.2d 174,178– tive action. Id. The public warning letters, 79 (N.J. Super. App. Div. 2003); see also Erin therefore, serve to regulate the particu- T. Welsh and Steven A. Karg, The Recent the FDA can. See Senate Comm. on Com- lar recipient and to provide guidance to all Expansion of Traditional Products Lia- merce, Sci., & Transp., Prod. Liab. Reform industry participants. bility—Personal Injury Claims Into More Act of 1997, S. Rep. No. 105-32, at 7 n. 60, 10 Advertising in the pharmaceutical indus- Complex Claims and Investigations, ALI- (1997) (noting the decline in availability of try also is checked by a self-regulating mech- ABA Course of Study, Products Liabil- certain medical products and information anism: the PhRMA Guiding Principles on ity: Pharmaceutical and Medical Device due to threat of product liability costs). Direct to Consumer Advertisements about Issues (August 18–19, 2005), SL038 ALI- Because of the highly specialized nature Prescription Medicines (“PhRMA Guide- ABA 347. One fact that they cannot cir- of this industry, however, the regulation lines”). Available at http://www.phrma.org/files/ cumvent, however, is the pre-existing and of information relating to drugs and other DTCGuidingprinciples.pdf. “PhRMA” is the acro- extensive regulation of drug labeling, pro- medical products should be left to people nym for the Pharmaceutical Research and motion, and advertising by the FDA. In the who have the technical experience needed Manufacturers of America, which is a leading consumer protection context, they have no for an informed assessment of whether a industry association that represents many good answer to the question: Isn’t regula- statement is accurate or misleading. See pharmaceutical and biotechnology compa- tion by the FDA enough? Pennsylvania Employee Benefit Trust Fund v. nies. The preamble to the PhRMA Guidelines, Zeneca, Inc., 2005 WL 2993937 at *5 (D. Del. which went into effect in January 2006, artic- Regulation by Litigation 2005). Unlike lay juries and judges, the FDA ulates the industry’s goal of voluntary com- Is Bad Social Policy has the expertise to back up such decisions. pliance with FDA regulation in particular If you want to shape the law through appel- Id. Further, by conducting public hearings, and with truthfulness in general. late decisions, you need to explain to the the FDA has the ability to consider the views First and foremost, we have a responsi- courts why your position makes sense. of the public at large, as well as scientists and bility to ensure that our DTC commu- You need to show that social policy is on industry participants. In contrast, a court nications comply with the regulations your side. When medical information is or jury can consider only admissible evi- of the Food and Drug Administration involved, there are compelling reasons why dence presented by the particular litigants (FDA). In general, the FDA requires all consumer class actions are bad from a pol- in the case, a restriction that increases the DTC information: icy standpoint. chances of arbitrary results. • To be accurate and not misleading; There is no doubt that class action lit- The use of private litigation in multiple • To make claims only when sup- igation can function as de facto regula- jurisdictions to regulate the flow of medi- ported by substantial evidence; tion simply because the stakes are so high. cal information also destroys uniformity, • To reflect balance between risks and “[R]egulation can be as effectively exerted and thus frustrates one of the principal rea- benefits; and through an award of damages as through sons for giving the FDA authority to establish • To be consistent with the FDA- some form of preventive relief.” San Diego national standards for marketing prescrip- approved labeling. Bldg. Trades Council v. Garmon, 359 U.S. tion drugs. The public, as well as the industry, Id. 236, 247 (1959). As explained by the Advi- benefits from uniform standards, consis-

For The Defense n April 2006 n 21 D r u g a n d M e d ical Device tently applied. See Brief of United States, 2004 pharmaceutical drugs are available labeling and advertising should have uni- WL 1143720 at *25, filed in Horn v. Thoratic to the American public should not be form application nationwide, which can Corp., 376 F.3d 163 (3d Cir. 2004). shifted away from the Food and Drug be achieved only through federal preemp- Finally, allowing the plaintiffs’ bar to Administration into the hands of plain- tion of state law. Because the FDA already challenge pharmaceutical communications tiffs’ lawyers, judges and juries. Many has determined what warnings should be through consumer fraud and unfair com- class actions against pharmaceutical included in labeling and advertising, any petition class actions actually can harm manufacturers are filed in spite of the other view necessarily conflicts with the the consumers who are supposed to ben- fact that the FDA has investigated an agency action. efit from such litigation. In any industry, alleged problem and concluded that the Although the preemption doctrine has the costs of doing business must be cov- drug should remain on the market. Class not been uniformly applied, it is evolving ered by the price of the goods sold. This action lawyers borrow from the factual into a sound defense in consumer protec- fundamental economic principle means work undertaken by the agency and use tion actions challenging medical advertis- that high defense and settlement costs will the class action vehicle as a way to reliti- ing. See also Pennsylvania Employee Benefit increase the prices paid by the consum- gate the agency’s decisions. The author- Trust Fund v. Zeneca, Inc., 2005 WL 2993937 ers for the drugs. The risks from this type ity to decide whether consumers should (D. Del. 2005) (holding that the preemption of action also could deter drug companies have access to pharmaceuticals should doctrine bars state law actions based on from DTC communications in the first remain with the FDA. And if there are statements in advertising that comply with place. This outcome would deprive con- problems with FDA, the solution is to fix FDA-approved labeling); New Jersey Cit- sumers of a valuable source of information. the agency—not to transfer its power to izen Action v. Schering-Plough Corp., 842 While some people think DTC advertising self-interested class action lawyers. A.2d 174, 177 (N.J. 2003) (holding that “the is not appropriate, the agencies who have Id., 2005 WL at 627977, at *75. wording of the ads, to the extent that it is studied the issue have found otherwise. subject to FDA oversight, see 21 CFR §202.1, In a detailed report supported by surveys Regulatory Compliance Defenses is similarly not actionable”); Murphy v. and data, the FTC staff has advised the FDA The FDA’s regulation of drug advertising Playtex Family Products Corp., 176 F. Supp. that “empirical evidence suggests that the gives rise to a number of grounds for dis- 2d 473, 483 (D. Md. 2001) (holding that FDA’s current approach to regulating DTC missal of piggy-back class actions. Fol- plaintiffs’ consumer protection act claim advertising generally confers benefits on lowing is a summary discussion of some is expressly preempted by the requirements consumers.” See In the Matter of Request for arguments you can make if you face a con- of 21 C.F.R. §801.430). Comments on Consumer-Directed Promo- sumer challenge to regulated advertising. Indeed, the FDA recently has embraced tion, Docket No. 2003N-0344, Comments Keep in mind that this is not an exhaus- the preemption doctrine as official agency of the Staff of the Bureau of Consumer Pro- tive list, and the defenses are evolving. policy. For example, in a letter brief filed in tection, the Bureau of Economics, and the Although the labels given these legal the- a product liability “failure to warn” case, Office of Policy Planning of the Federal ories differ based on subtle variations in the FDA explained that its decision-making Trade Commission, December 1, 2003, at 5, analysis, these defenses have a common process is not limited to the wording of the available at http://www.ftc.gov/be/v040002text. theme: lay tribunals should not be regulat- warnings that are found on labels. It also pdf. “Survey evidence suggests that DTC ing the flow of information relating to the involves a decision to limit the warnings to ads have provided consumers with useful use and attributes of medicine. those that are approved. See Brief of United information about the drug options open States, 2004 WL 1143720 at *29, filed in Horn to them, which, in turn, has empowered Preemption Doctrine v. Thoratic Corp., 376 F.3d 163 (3d Cir. 2004) consumers to interact with their physicians The preemption doctrine is “a crazy quilt (affirming summary judgment on preemp- more effectively. Studies of the impact of of decisions.” Joseph J. Leghorn, et al., Pre- tion grounds). The FDA provided additional DTC advertising on demand do not sup- emption Defenses: The Latest Information facts and extensive arguments supporting port the conclusion that it has led to the and Strategies. Will It Ever Make Sense?, preemption in the preamble to its recent increased use of inappropriate drugs or ACI Drug and Medical Device Litigation final rule on prescription drug labeling. increased drug prices.” Id. (December 2005). Some courts have held See Requirements on Content and Format The Senate Judiciary Committee Report that FDA regulation preempts state law for Human Prescription Drug and Biological on the Class Action Fairness Act stresses actions. See, e.g., Dowhal v. Smith Kline Bee- Products, 71 Fed. Reg. 3922, 3933–36 (Janu- that “[t]he authority to decide whether cham Consumer Healthcare, 12 Cal. Rptr. ary 24, 2006). The FDA’s express adoption of consumers should have access to pharma- 3d 262 (Cal. 2004); Dusek v. Pfizer Inc., the preemption doctrine as agency policy in ceuticals should remain with the FDA.” S. 2004 WL 2191804 (S.D. Tex. 2004). Some the course of its formal rule-making process Rep. No. 109-14 (2005), reprinted in 2005 have gone the other way. See, e.g., Cart- is a powerful statement that should propel U.S.C.C.A.N. 3, 2005 WL 627977, at *75. wright v. Pfizer, 369 F. Supp. 2d 876, 885– the preemption defense in future appellate The rationale for this point applies equally 86 (E.D. Tex. 2005); Zikis v. Pfizer Inc., 2005 decisions. See Geier v. Am. Honda Motor to the regulation of pharmaceutical label- WL 1126909 (N.D. Ill. 2005). Co., Inc., 529 U.S. 861, 883 (2003) (noting ing, promotion, and advertising: The conflict over preemption proves the deference given to federal agency’s views [R]egulatory decisions regarding which need for preemption. The rules for drug on preemption).

22 n For The Defense n April 2006 Safe Harbor Provisions the FTC’s tendency to regulate by obtain- gist of the argument is that a plaintiff can- Although not technically preemption, there ing voluntary compliance with its policies, not satisfy the “consumer expectation test” is a comparable defense incorporated into rather than engaging in formal rulemak- as a matter of law where the label complies many state consumer protection statutes. ing.” Id. at 43. The court, therefore, had with FDA requirements. The significance of These “safe harbor” provisions defer, as a ample support for its conclusion “that the this defense is that it can apply to labeling matter of state law, to federal regulation. For FTC’s informal regulatory activity, includ- claims even when there is no federal pre- example, Delaware’s Consumer Fraud Act ing the use of consent orders, comes within emption. Thus, if you find yourself in a ju- expressly does not apply “[t]o any adver- the scope of section 10b(1)’s requirement risdiction that has rejected the preemption tisement or merchandising practice which that the specific authorization be made ‘by doctrine in medical advertising cases, you is subject to and complies with the rules laws administered by’ a state or federal reg- nonetheless can argue that regulatory com- and regulations, of and the statutes admin- ulatory body.” Id. at 41. pliance compels dismissal under this com- istered by, the Federal Trade Commission.” A pharmaceutical case from the Sev- mon law principle. Although the “consumer 6 Del. C. §2513(b)(2). Recognizing that the enth Circuit also played a prominent role in expectation” defense arose in the context of FTC and the FDA share jurisdiction over the Price opinion. Id., citing Bober v. Glaxo products liability, its rationale also applies the regulation of drug marketing, with pri- Wellcome PLC, 246 F.3d 934 (7th Cir. 2001). to consumer protection actions. mary responsibility going to the FDA, the The Bober court pointed out that state- An illustrative case is Murphy v. Playtex court in Penn. Employee Benefit Trust Fund ments designed to comply with the tech- Family Products Corp., supra. The court in recently held that advertising is not action- nical requirements of the highly regulated Murphy addressed claims based on alleg- able under the Delaware consumer statute pharmaceutical industry could very well edly improper tampon labeling. See Mur- if it is consistent with FDA-approved label- be confusing or even misleading to a con- phy, 176 F. Supp. 2d at 473. After dismissing ing. 2005 WL 2993937 at *2. sumer. 246 F.3d at 942–43. Following the the consumer protection claims under the An appellate decision reversing a $10 bil- Bober analysis, the Price court held that preemption doctrine, the Murphy court lion award involving the tobacco industry “even if those statements may tend to be agreed with the plaintiffs that there was no recently made clear that formal agency reg- confusing or misleading and even if there federal preemption of the product liability ulation is not a prerequisite to the safe har- is no express authorization for the mak- claim. Id. at 488. The court then agreed with bor defense under Illinois law. See Price v. ing of such statements in the applicable the defendant, however, that the plaintiffs Philip Morris, Inc., N.E.2d , 2005 federal regulations,” the statements were could not prove a case under the consumer WL 3434368 (Ill. App. 2005). Significantly, entitled to protection if they “fall within expectation product liability test. Id. at 489. the court based its decision on precedent the boundaries established by federal law.” Under the consumer expectation test, lia- from the pharmaceutical industry and on Price, 2005 WL 3434368 at *43. bility attaches where a product is more dan- evidence regarding voluntary compliance The Price decision has many interesting gerous than an ordinary consumer would mechanisms. facets. It used a de novo standard of review expect. Id. at 485. Following precedents from The Illinois Consumer Fraud Act does to reverse what appeared to be a finding the Ninth and Seventh Circuits, the Murphy not reach actions that are “specifically of fact. It stressed that a layperson’s per- court reasoned that an ordinary consumer is authorized by laws administered by” the ception of “misleading” material should not entitled to expect a product to perform regulatory body. 815 ILCS 505/10b(1). not invoke liability with respect to state- more safely than its government mandated Although the lower court in Price made a ments made in compliance with technical warnings indicate. Id. at 488 (citing Haddix finding that the FTC did not specifically requirements imposed by the FDA. Perhaps v. Playtex Family Products Corp., 138 F.3d authorize the use of the disputed terms, most significantly, it indicates that volun- 681 (7th Cir. 1998) and Papike v. Tambrands the appellate court held that it was enti- tary compliance—even through consent Inc., 107 F.3d 737 (9th Cir. 1997)). tled to de novo review because the facts orders—can constitute regulatory activity were undisputed. Id. at *29. The court then deserving of safe harbor protection. Under Risk/Utility Analysis agreed with the defendant that, as a matter the Price analysis, the fact that the FDA The Restatement’s “risk-utility” doctrine of law, the agency authorization need not be challenged conduct at some point in time also shows that the regulatory compliance express to be specific. Id. at *38. might not support liability if the problem defense is rooted in established common The Price court carefully noted the evi- was voluntarily corrected through subse- law principles. Comment k to the Restate- dence that an agency does not regulate quent dealings with the agency. Thus, evi- ment (Second) of Torts §402A provides a solely by formal action. “In lieu of formal dence of a transgression can at the same famous example of the risk-utility doctrine rule-making, the FTC can withdraw pro- time possibly establish a preemption or in the medical context: posed rules if those affected voluntarily safe-harbor defense—if it is accompanied [T]he vaccine for the Pasteur treatment of agree to comply. In addition, the FTC can by corrective behavior. rabies… not uncommonly leads to very issue advisory opinions upon request by an serious and damaging consequences industry actor or other interested party.” Consumer Expectation Test when it is injected. Since the disease itself Id. at 20. The court observed that “[t]he Defendants have successfully relied on the invariably leads to a dreadful death, both United States Court of Appeals for the Dis- “consumer expectation test” to defeat lia- marketing and the use of the vaccine trict of Columbia Circuit long ago noted bility based on challenges to labeling. The are fully justified, notwithstanding the

For The Defense n April 2006 n 23 D r u g a n d M e d ical Device

unavoidable high degree of risk which the advertising and purchase of the prod- Develop a Good Record they involve. Such a product, properly uct is at best an attenuated one.” New Jer- Take a good look at the Price case. Its under- prepared, and accompanied by proper sey Citizen Action v. Schering-Plough Corp., lying theme is that agency regulation is not directions and warning, is not defective, 842 A.2d at 178. The learned intermediary just about formal rulemaking. This means nor is it unreasonably dangerous. doctrine, therefore, should bar consumer that you can build a record to support Section 6 of the Restatement (Third) of protection actions based on prescription regulatory compliance defenses by docu- Torts applies an evolved version of the risk- drug advertising. See Wyeth-Ayerst Labs. menting voluntary compliance activities. utility concept to prescription drug com- v. Medrano, 28 S.W.3d 87, 93–94 (Tex. App. Signing onto the PhRMA guidelines would panies. In a nutshell, before a drug can 2000) (reversing denial of learned inter- demonstrate intentional submission to the be marketed, its benefits must be weighed mediary defense to claim under Deceptive regulatory process. Pro-active dialogue against its risks, and reasonable warnings Trade Practices Act). with the FDA can yield evidence of agency of foreseeable risks must be provided. See action to support an express preemption Restatement (Third) of Torts: Products Lia- First Amendment Protection defense. Request advisory opinions. Raise bility §(b)–(d). If these steps are taken, then Truthful pharmaceutical advertising is your issue at multiple levels, talking to sci- a drug company has a defense to liability. commercial speech entitled to protection entific as well as enforcement personnel Advertising that complies with FDA reg- under the First Amendment. Thompson at the FDA. If you receive a warning letter ulation should not be actionable because v. Western States Medical Center, 535 U.S. from the FDA, do a good job of document- the required risk-utility analysis and devel- 1497 (2002). While state law can impose ing corrective action. If a lawsuit is filed opment of reasonable warnings of foresee- restrictions on commercial speech that later, you will have the facts at hand to show able risk is an essential aspect of the FDA is false or “inherently misleading,” state that your dealings with the FDA are an inte- approval process. See Murphy, 176 F. Supp. law cannot regulate speech that is only gral part of the regulatory process that pre- 2d at 492–93 (granting summary judg- “potentially misleading” without satisfy- empts or otherwise protects the advertising ment based, in part, on FDA risk/utility ing at least the intermediate scrutiny test at issue from challenge under state law. findings); Grundberg v. Upjohn Co., 813 described in Central Hudson Gas & Elec. P.2d 89, 97 (Utah 1991) (holding that risk/ Corp. v. Public Serv. Comm’n of N.Y., 447 Create a Legal “Road Map” benefit analysis performed by the FDA U.S. 557, 566 (1980). Whether the speech Before you start a trip, it usually is a good was sufficient). Significantly, this is not a is “inherently misleading” is a question idea to have a road map handy. Even if preemption argument. Rather, it is based of law. See Peel v. Attorney Registration & you think you know the way, you might on the established common-law principle Disciplinary Comm’n of Illinois, 496 U.S. encounter a detour. A map can show you that a drug company that acts reasonably 91, 100 (1990). alternate routes to your destination. The to weigh and convey both the benefits and Significantly, commercial speech is only same is true for a case. As soon as you get the risks should not be liable. “inherently misleading” if it would be mis- the complaint, take the time to conduct a leading in all circumstances.” Bioganic Safety thorough legal analysis of the regulatory Learned Intermediary Doctrine Brands, Inc. v. Ament, 174 F. Supp. 2d 1168, compliance defenses and put it down in The “learned intermediary doctrine” can 1180 (D. Colo. 2001). Thus, advertising that is writing. The memorandum can serve as be a good vehicle for presenting a regu- found by the FDA to be not misleading can- the basis for your dispositive motions and latory compliance defense. The learned not be “inherently misleading,” and is pro- eventual appeal. These defenses are build- intermediary doctrine recognizes that the tected by the First Amendment from state ing momentum, so be sure to update your prescribing physician is the proper party to law restrictions. See Bioganic Safety, 174 F. analysis regularly. inform a patient of the risks of medicine. Supp. 2d at 1180–82) (holding as a matter of You might be able to keep your litiga- The duty of the drug company, therefore, law that statements contained in product’s tion trip short with a motion to dismiss, as is satisfied when the company reasonably advertisements and EPA-approved label were occurred in Pennsylvania Employee Benefit discloses risks to physicians. See, e.g., Ster- “not inherently misleading”). Trust v. Zeneca, Inc. and in New Jersey Cit- ling Drug, Inc. v. Cornish, 370 F.2d 82, 85 izen Action v. Schering-Plough Corp. The (8th Cir. 1966). The relationship between Future Strategy: Begin motion to dismiss should be as thorough the drug company and the patient is too with the End in Mind as possible to make sure that you do not remote to support liability. Shaping the law through appellate opinions waive any arguments that you might want Even with DTC advertising, the regu- requires a good record to support a reasoned to make on appeal. lated nature of the pharmaceutical industry legal analysis. The groundwork must be- If a successful motion to dismiss is requires a “learned intermediary” before gin early—even before litigation has com- unlikely because you are in a jurisdiction a patient can have access to prescription menced. In other words, you should “Begin that is hostile to the preemption defense drugs. “In this context, that is, within a with the End in Mind.” See Stephen R. Covey, or you need to point to evidence of agency highly regulated industry in which the ulti- The 7 Habits of Highly Effective People (Simon approval, then consider asking for bifur- mate consumer is not in fact free to act on & Schuster 1989). Following are some point- cation of the regulatory compliance issue. claims made in advertising in any event, ers on what you can do to advance regulatory Many courts will permit limited discovery the relationship between words used in compliance defenses through case law. and summary judgment motions on this

24 n For The Defense n April 2006 type of threshold issue, which will save ant to 28 U.S.C. §1292(b). This procedure while your dispositive motion is pending everyone time and expense. This procedure requires a controlling issue that involves in the trial court, you should be lining up also is useful for framing up an interlocu- developing and significant legal princi- potential amici curiae who can add weight tory appeal if you are not successful with ples that justify early intervention by the to the significance of your issue if you have your motion. higher court. A number of appellate courts to file a petition under §1292(b). have accepted discretionary review of pre- Be Ready for an emption issues under this procedure. See, Conclusion Interlocutory Appeal e.g., Philip Morris, Inc. v. Harshbarger, 122 There are many reasons “regulation by liti- If you put together a great dispositive F.3d 58 (1st Cir. 1997). The other regula- gation” is not appropriate when it comes to motion, in your heart of hearts you think tory compliance defenses discussed earlier prescription drug advertising. The regula- you are going to win it. If the motion fails, in this article are equally worthy of interim tory compliance defenses discussed above, however, you need to be able to act quickly appellate review. See Perkins v. F.I.E. Corp., while still evolving, honor both social pol- to preserve possible avenues for an inter- 762 F.2d 1250 (5th Cir. 1985). icy and established principles of law. If locutory appeal. Because appeals under §1292(b) are not these defenses are presented to courts Interlocutory orders are not appealable routinely granted, it is important to con- across the country in well developed and as a matter of right. It is possible, however, vince the courts that your issue is special. fully supported analyses, a cohesive body to petition for discretionary review of the Be sure to include the social policy argu- of law should emerge that will end piggy- denial of a motion to dismiss or motion for ments that favor your cause. Also, a lit- back litigation in this arena. summary judgment in federal court pursu- tle help from your friends never hurts. So,

For The Defense n April 2006 n 25