The word requiem (a composition for the dead) comes to mind as an appropriate description for the Supreme Court’s seminal March 4, 2009 decision in Wyeth v. Levine.1 Indeed, some have argued that, in the context of prescription drug failure to warn cases, the preemption defense is now dead – a relic of the past decade which can now be buried in the fatigues of history.
While the Supreme Court’s decision is still new, there have been a number of post-Levine decisions illustrating the futility of the preemption defense in all but the most clear-cut cases and many of the pre-Levine preemption rulings have now been vacated or reversed. In the context of antidepressant cases, which the defense bar had dubbed a “poster-child for preemption,” Courts following Levine have either denied preemption or reversed previous preemption rulings.2 A review of recent post-Levine decisions confirms that, with respect to current prescription drug failure to warn cases, the preemption defense appears to be dead and will only be successful in the future in the most rare of circumstances. In this article, we take a brief look at the birth, death and anticipated attempts by drug manufacturers to resurrect the preemption defense.
A. The Birth of Preemption
The doctrine of preemption is rooted in the Supremacy Clause, U.S. Const. Art. VI, cl.2, which provides that the “Constitution, and the Laws of the United States which shall be made in Pursuance thereof … shall be the supreme Law of the Land.” In the seminal case Gibbons v. Ogden, the Supreme Court interpreted this language to invalidate state laws that “interfere with, or are contrary to,” federal law, the genesis of the preemption doctrine. 3 One situation in which preemption arises is when state law “conflicts” with federal law. Conflict preemption applies when (a) “compliance with both federal and state regulations is a physical impossibility,” or (b) when state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”4
B. Conflict Preemption In Prescription Drug Cases
In the 1930’s, Congress became increasingly concerned about unsafe drugs and fraudulent marketing of drugs, and thus enacted the Federal Food, Drug and Cosmetic Act of 1938 (“FDCA”). The Act required new drugs to go through a pre-market approval process before they could be distributed. As part of the pre-approval process, the manufacturer had to propose a label which would have to be approved by the Food and Drug Administration (“FDA”). Importantly, when Congress enacted the FDCA, it was well aware of ongoing state tort actions over drug products, yet purposely decided not to include a private right of action for damages in the FDCA on the grounds that it was “unnecessary,” because a “common-law right of action exists.”5
In light of this legislative history, drug manufacturers rarely invoked the preemption defense and, when they did invoke it, it was almost always unsuccessful. 6 That began to change in 2001 when, seemingly overnight, courts began to be deluged with preemption motions in prescription drug cases. In their preemption motions, manufacturers would generally argue that, since the FDA approved their product’s labeling, any subsequent modification (including the addition of enhanced warnings) by the manufacturer would render the drug misbranded and subject the manufacturer to potential prosecution or enforcement action. Manufacturers contended that it would be impossible for them to comply with both federal law and state law (i.e., potential jury verdicts). Manufacturers further contended that a jury verdict would result in over-warning and, as a consequence, would stand as an obstacle to the FDA’s accomplishment of regulatory objectives. Curiously, in a number of these cases, the FDA joined in the battle, filing amicus briefs in support of drug manufacturers. In 2006, the FDA also began making statements and revising its regulations in an effort to buttress the pharmaceutical industry’s preemption defense.7
Where previously the preemption defense was almost uniformly rejected by courts, some courts were swayed by the FDA’s new pro-preemption stance and began granting preemption motions.8 In dismissing the plaintiffs’ claims in one case, the court suggested that plaintiffs should find solace in the fact that “not all tragedies have legal remedies…”9 Thus, while general preemption concepts have existed since the formation of our Constitution, the illegitimate birth of the “successful” preemption defense in prescription drug failure to warn cases did not occur until the turn of the 21st Century and at a time when the agenda-driven Bush administration was in full and unrestrained force.
C. Mr. Troy Goes to Washington
The story begins, as these stories often do, with an ambitious and politically connected lawyer. On August 20, 2001, Daniel Troy, Esq. was appointed by President George W. Bush to be Chief Counsel of the FDA. Prior to his appointment, Mr. Troy worked in the private sector representing pharmaceutical companies, including Pfizer, Inc. Shortly after Mr. Troy took his position with the FDA, the issue of preemption was raised in a case against Pfizer related to the antidepressant Zoloft in the Ninth Circuit – Motus v. Pfizer, Inc.
In the Ninth Circuit case, the plaintiffs appealed a district court order unrelated to preemption and Pfizer cross-appealed on the district court’s order rejecting Pfizer’s argument on preemption.
10 While the Motus appeal was pending in the Ninth Circuit, Pfizer’s lead national counsel and attorney of record in the Motus case telephoned Mr. Troy and asked him to intervene in the Motus appeal by submitting an amicus brief supporting Pfizer’s position on preemption. Mr. Troy ceded to the wishes of his former client and, on behalf of the FDA, submitted the Motus amicus brief. In the end, the Ninth Circuit did not discuss the issues raised by the amicus brief and did not rule on preemption.11
Thereafter, Mr. Troy intervened in a number of pharmaceutical cases. According to one attendee at a drug industry meeting, he solicited attendees to submit proposals to him seeking FDA intervention in their drug cases and reportedly stated “we can’t afford to get involved in every case, we have to pick our shots,” so, “make it sound like a Hollywood pitch.”12 Mr. Troy left the FDA in November 2004 and returned to the private sector (and back to representing the pharmaceutical industry). The law firm Mr. Troy joined touted him as the person who “played a principal role in the FDA’s generally successful assertion of preemption in selected product liability cases.”
Although no longer working at the FDA, the preemption seeds Mr. Troy had sown continued to cultivate. The FDA drafted additional amicus briefs in other pharmaceutical cases and the FDA went as far as to re-draft FDA rules and policies. Significantly, in 2006, the FDA issued a Preamble which, for the first time, proclaimed that the FDCA establishes both a “floor and a ceiling” and, thus, FDA approval of labeling preempts conflicting or contrary State law.13
D. An Unholy Matrimony
The “marriage” between the FDA and pharmaceutical industry and their joint over-reaching propagation of the preemption defense convinced a number of courts to grant manufacturers’ preemption motions. By finding plaintiffs’ claims preempted, courts assured that manufacturers would escape all liability for their negligent and, at times, fraudulent conduct.14
Not all Courts were convinced however. Many courts saw through the smoke and mirrors and firmly held that preemption did not apply.15 In one of these cases, Tucker v. SmithKline Beecham, the Court was initially swayed by the manufacturer (and the FDA’s) preemption arguments, but on reconsideration, the Court recognized that the “FDA’s current position on preemption is not ‘long standing’ but in fact a ‘180-degree reversal’ from its earlier stance.”16 The Tucker Court vacated its earlier preemption ruling and held that the plaintiff’s claims were not preempted.17
For nearly a decade, the preemption battle raged and divided trial courts across the country, eventually reaching the hallowed chambers of the Supreme Court and culminating in the Court’s landmark decision in Levine.
The Death
A. Wyeth v. Levine – Sounding the Death Knell
The myriad of conflicting preemption rulings across the country, as well as the FDA’s recent preemption pronouncements, persuaded the Supreme Court to grant a petition for certiorari in Levine, which directly addressed the issue of preemption.
In Levine, the plaintiff (Diana Levine) was severely injured when a clinician improperly injected an anti-nausea drug Phenergan into her artery. Ms. Levine sued Wyeth, the manufacturer of the drug, claiming that Wyeth failed to provide an adequate warning regarding the risks involved with the various administering methods of the drug. The case was presented to a jury and the jury concluded that Wyeth failed to properly warn. The issue before the Supreme Court was whether Ms. Levine’s claims were preempted by the FDCA and applicable FDA regulations. Wyeth (and the FDA, which filed an amicus brief in support of preemption) argued that it would have been impossible for Wyeth to comply with both state-law duty and federal law, and that the state tort action created an unacceptable obstacle to the accomplishment and execution of the full purposes and objectives of Congress. The Supreme Court rejected both arguments.
The Court rejected Wyeth’s and the FDA’s broad claims of conflict preemption, including claims that, when the FDA approves a drug label, the agency strikes a balance that establishes both a “floor” and a “ceiling” with respect to the appropriate warnings for that drug. The Court concluded that a drug manufacturer’s claim of implied conflict preemption will fail where it cannot present “clear evidence” that the FDA “would have prohibited” the manufacturer from adding a stronger warning.18
In reaching these conclusions, the Court began its analysis with two cornerstones of preemption jurisprudence: the “purpose of Congress” and the “presumption against preemption.” The Court analyzed the legislative history and found that “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”19 Further, in light of the historic presence of state law remedies for injured consumers, the Court found that the presumption against preemption applies to implied conflict preemption cases involving prescription drugs.
20
The Court then applied those cornerstone principles to reject Wyeth’s arguments. First, the Court rejected Wyeth’s claim that FDA rules gave it no right to change its drug label without prior FDA approval, making it impossible to comply with the jury verdict. The Court found that the FDA’s regulations permit precisely such manufacturer-initiated changes. The Court concluded that FDA rules properly “account for the fact that risk information accumulates over time and that the same data may take on a different meaning in light of subsequent developments.”21 Because Wyeth “could have analyzed the accumulating data” about the risks associated with its drug, the FDA’s rules allowed it to add a stronger warning without prior FDA approval.22
Second, the Court rejected Wyeth’s claim that modifying its label without FDA approval would have rendered its drug misbranded under federal law. The Court explained that the impossibility and misbranding arguments were premised on a “fundamental misunderstanding” of federal drug regulation. Namely, that “the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.”23 The Court emphasized that “it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times”and the manufacturer “is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.”24
Third, the Court rejected the FDA’s position as outlined in its 2006 Preamble and amicus briefs, that state-law failure-to-warn claims are preempted because federal approval of a label “establishes both a floor and a ceiling for drug regulation.”25 As the Court explained, the “most glaring problem with this argument is that all evidence of Congress’ purposes is to the contrary.”26 Notably, the Court held that failure to warn lawsuits a) complement the goals of Congress, since such lawsuits “uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly”; b) “may motivate injured persons to come forward with information”; and c) “lend force to the FDCA’s premise that manufacturer’s, not the FDA, bear the primary responsibility for the drug labeling at all times.”27 Applying those standards to the facts in Levine and finding the record contained no evidence that FDA would have prohibited Wyeth from strengthening its warning based on the risk information revealed at trial, the Court rejected Wyeth’s preemption arguments.28
B. Burying Preemption
Since the Supreme Court’s decision in Levine, many courts have vacated and reversed previous preemption rulings. For example, in Colacicco v. Apotex, Inc., the Third Circuit relied upon the FDA’s various pronouncements and held that the plaintiffs’ failure to warn claims were preempted.29 In Colacicco, the plaintiffs alleged that the manufacturers of Zoloft and Paxil should have included a warning that the antidepressants could increase the risk of suicidal behavior in some patients. The Third Circuit, relying largely on the FDA’s amicus brief, held that the FDA would have deemed such a warning misbranded. 30 After issuing the Levine ruling, the Supreme Court vacated the Third Circuit’s ruling in Colacicco and asked the court to reconsider its prior ruling in light of Levine.31 The Third Circuit, thereafter, asked the parties’ to prepare briefs discussing the implications of the Levine decision. The antidepressant manufacturers argued that Levine was factually distinguishable and that the court should affirm its earlier preemption ruling. The plaintiffs argued that Levine was applicable and the earlier preemption ruling should be reversed. The Third Circuit agreed with plaintiffs, vacated its earlier preemption decision and remanded the cases back to the district court. 32 That same day, the FDA submitted a letter to the Third Circuit withdrawing its earlier pro-preemption amicus brief.
Similarly, in the case Brocket v. Wyeth, the Texas Appellate Court relied upon Levine to reverse a trial court’s pre-Levine preemption ruling.33 In Brocket, the plaintiff sued the manufacturer of Prempro, a hormone replacement therapy, alleging, inter alia, that the manufacturer failed to warn of the increased cancer risk associated with the drug. The trial court held that the plaintiff’s failure-to-warn claims were preempted. The Appellate Court, relying upon Levine, reversed the trial Court and held:
Given the [Levine] Court’s statement that a “central premise” of federal-drug regulation is that “the manufacturer bears responsibility for the content of its label at all times,” and the lack of evidence that the FDA would have rejected a stronger warning concerning the risk of breast cancer, we cannot affirm the trial court’s dismissal of [plaintiff’s] failure-to-warn claim at the summary-judgment stage based on federal conflict preemption. 34
The holding of Levine has also been extended to cases involving generic drugs. In Stacel v. Teva Pharmaceuticals, the plaintiff alleged that she developed lupus as a result of ingesting the antibiotic minocycline, a generic drug.35 The generic manufacturer argued that the plaintiff’s claims were preempted because, under federal law, its label must be identical to the brand name drug. The generic manufacturer cited a 2008 FDA proposed rule which purportedly supported its preemption argument.36 The Court noted that Levine was not directly on point because, in Levine, the drug at issue was a brand name drug and generic drugs go through a slightly different approval process.37 Nonetheless, the Court relied upon Levine and the legislative history of the generic drug statutes to conclude that generic manufacturers, like brand name manufacturers, are obligated to update their labels to warn of newly discovered risks. Specifically, the Court held “[t]here is no reason to conclude that Congress felt differently about generic drugs.”38 The Court went on to state: “[n]or, from this history and the Court’s analysis in Levine, can the court agree that permitting state-law tort actions would necessarily frustrate the purpose of Congress in passing the [generic drug] Act.”39 Accordingly, the Court denied the generic manufacturer’s preemption arguments.
Life After Death
The Supreme Court did not find that state-law failure-to-warn claims could never be preempted, however, the circumstances under which preemption would apply is extremely narrow. The Court ruled that preemption would apply to those rare cases in which the manufacturer presents “clear evidence” that the FDA “would have prohibited [the manufacturer] from adding a stronger warning.”40 While this caveat provides a sliver of an opportunity for manufacturers to argue preemption, none of the current preemption cases to our knowledge comes within the Court’s narrow exception.
Not to be deterred, however, the defense bar is already conjuring up potential ways to breathe new life into the preemption defense. For instance, some within the defense bar have found a ray of hope in the recently enacted Risk Evaluation and Mitigation Strategy (“REMS”) provision, added by the Food and Drug Administration Amendments Act of 2007. The 2007 Amendments included a new section, 21 U.S.C. § 355-1, captioned “Risk Evaluation and Mitigation Strategies.” The new Act provides that the FDA may require a REMS if the FDA becomes aware of new safety information and decides that a REMS “is needed to ensure that the benefit of the drug outweigh the risks.”41
The defense bar is now postulating that a drug (and specific risk) that have gone through the REMS process would warrant preemption under the new framework established by Levine. Given that REMS is still in its infancy, as is Levine, there have been no cases to test its implications on preemption. However, as drugs begin to go through the REMS process, legal practitioners can expect to see preemption motions premised upon these new regulations, and only time will tell what impact, if any, the REMS process will have on preemption.
Conclusion
Perhaps no other legal defense has been as heatedly debated as the preemption issue in the last decade. The Supreme Court’s decision in Levine should cause a dramatic decline in the number of preemption motions filed in prescription drug cases and result in more uniformity in preemption decisions hereafter.
As all houses of cards must do in the end, the preemption defense has taken a well-deserved fall. The Supreme Court’s rejection of the FDA’s agenda-driven pro-preemption policies, as well as the arrival of a new administration, should end the “unholy matrimony” between industry and the FDA. Meanwhile, the defense bar will look for new and creative ways to come within Levine’s narrow exception. It will be an uphill battle for them. Indeed, it is difficult to imagine how companies will be able to prove by “clear evidence” that the FDA “would have prohibited” a warning in any but the most extreme, non-speculative circumstances. Only time will tell.
Published in LexisNexis® Mealey’s™ Emerging Drugs & Devices | Volume 14, Issue#10, May 21, 2009
Bijan Esfandiari is the lead law and motion attorney at Baum Hedlund Aristei & Goldman in Los Angeles and is a member of the firm’s pharmaceutical drug product liability litigation team. For more than 19 years, Baum Hedlund has been at the forefront of the SSRI [selective serotonin reuptake inhibitor] antidepressant litigation and has represented thousands of victims of drug injury and death including more than 100 individuals across the country in suicide and suicide attempt cases involving SSRI antidepressants such as Paxil, Zoloft and Prozac. Mr. Esfandiari has successfully argued against preemption in numerous cases, including Tucker v. SmithKline Beecham Corp., 596 F.Supp.2d 1225 Shepardize (S.D.Ind. 2008); Knipe v. SmithKline Beecham, 583 F.Supp.2d 553 Shepardize (E.D.Pa. 2008); Collins v. SmithKline Beecham Corp., 2008 WL 744070 (Pa. Ct.Com.Pl. March 11, 2008); and Turek v. SmithKline Beecham, Case No. 3596 (Pa. Ct.Com.Pl. March 18, 2009). Mr. Esfandiari also co-authored an amicus brief in support of the respondent, Diana Levine, in Wyeth v. Levine, 129 S.Ct. 1187 Shepardize (2009). Copyright 2009 by Bijan Esfandiari.
1.Wyeth v. Levine, 129 S.Ct. 1187 (2009)
2. See e.g.,Colacicco v. Apotex, Inc., Case No. 06-3107 (3rd Cir., April 28, 2009) (relying on Levine and vacating previous preemption ruling); Brocket v. Wyeth Pharmaceuticals, __ S.W.3d __, 2009 WL 997438 (Tex. App., April 14, 2009)(relying on Levine and reversing previous preemption ruling)Turek v. SmithKline Beecham, Case No. 3595 (Pa.Ct.Com.Pl., March 18, 2009) (denying preemption); Van Dyke v. GlaxoSmithKline, Case No. 2:05-cv-00153-ABJ (D.Wy. March 27, 2009) (relying on Levine and denying GSK’s preemption motion).
3. Gibbons v. Ogden, 22 U.S. 1, 211 (1824).
4.Sprietsma v. Mercury Marine, 537 U.S. 51, 64 (2002).
5. See H.R. 6110, 73d Cong. § 25 (1933); S. 1944, 73d Cong., 2d Sess. §24 (1933); Hearings on S. 1944 Before a Subcomm. of the S. Comm. on Commerce, 73d Cong. 400, 403 (1933); see also Levine, 129 S.C. at 1200, n.7 (citing legislative history).
6. See, e.g., Abbot v. American Cyanamid Co., 844 F.2d 1108, 1110-14 (4th Cir. 1988), cert. denied, 488 U.S. 908 (1988); Hurley v. Lederle Laboratories Div. of Am. Cyanamid Co., 863 F.2d 1173, 1176-77 (5th Cir.1989); Tobin v. Astra Pharm. Prods., Inc., 993 F.2d 528, 537 (6th Cir. 1993), cert. denied, 510 U.S. 914 (1993); Hill v. Searle Labs., 884 F.2d 1064, 1068 (8th Cir.1989); Graham v. Wyeth, 906 F.2d 1399, 1405 (10th Cir. 1990); Wells v. Ortho Pharm. Corp., 788 F.2d 741, 746 (11th Cir. 1986), cert. denied, 479 U.S. 950 (1986);Feldman v. Lederle Labs., Inc., 592 A.2d 1176, 1197 (N.J., 1991).
7. 71 Fed.Reg. 3922, 3934-36 (Jan. 24, 2006) (“2006 Preamble”).
8. See e.g., Sykes v. Glaxo-SmithKline, 484 F.Supp.2d 289, 318 (E.D.Pa. 2007); Mason v. SmithKline Beecham Corp., 546 F.Supp.2d 618 (C.D.Ill. 2008) (appeal pending); Dobbs v. Wyeth, 530 F.Supp.2d 1275 (W.D.Okla. 2008) (appeal pending).
9. Mason, 546 F.Supp.2d at 627.
10.Motus v. Pfizer, Inc., 127 F.Supp.2d 1085 (C.D. Cal. 2000).
11. Motus v. Pfizer Inc., 358 F.3d 659, 660 (9th Cir. 2004).
12. Congressman Maurice Hinchey website at http://www.house.gov/hinchey/issues/fda.shtml
13. 71 Fed.Reg. at 3934-36.
14. See e.g.,Mason, 546 F.Supp.2d at 627.
15. As way of example, the following pre-Levine cases refused to find preemption: Knipe v. SmithKline Beecham, Corp., 583 F.Supp.2d 553 (E.D.Pa. 2008) (Paxil); Tucker v. SmithKline Beecham Corp., 596 F.Supp.2d 1225 (S.D.Ind. 2008) (Paxil);In re Vioxx Prods. Liability Litigation, 501 F.Supp2d 776, 788-789 (E.D.La.2007) (Vioxx); In re Zyprexa Prods. Liability Litigation, 489 F.Supp.2d 230, 275-278 (E.D.N.Y 2007) (Zyprexa); Perry v. Novartis Pharma. Corp., 456 F.Supp.2d 678, 685-87 (E.D.Pa.2006) (Elidel); Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964 (D. Neb. 2006) (Zoloft); Witczak v. Pfizer, 377 F.Supp.2d 726 (D. Minn. 2005) (Zoloft); Cartwright v. Pfizer, Inc., 369 F. Supp. 2d 876, 881-87 (E.D. Tex. 2005) (Zoloft); Caraker v. Sandoz Pharmaceuticals Corp., 172 F.Supp.2d 1018, 1044 (S.D.Ill. 2001) (Parlodel).
16. Tucker, 596 F.Supp.2d at 1232.
17. Tucker, 596 F.Supp.2d at 1237.
18. Levine, 129 S.Ct. at 1198-99 & n.6.
19. Levine, 129 S.Ct. at 1200.
20. Levine, 129 S.Ct. at 1195 n.3.
21. Levine, 129 S.Ct. at 1197.
22. Id.
23. Id.
24. Levine, 129 S.Ct. at 1197-98 (emphasis added). .
25. Levine, 129 S.Ct. at 1199
26. Id.
27. Levine, 129 S.Ct. at 1202.
28. Levine, 129 S.Ct. at 1199, 1204.
29. Colacicco v. Apotex, Inc., 521 F.3d 253 (3rd Cir. 2008).
30.Colacicco, 521 F.3d at 269.
31.Colacicco v. Apotex, Inc., 129 S.Ct. 1578 (U.S. Mar 09, 2009).
32.Colacicco v. Apotex, Inc., Case No. 06-3107 (3rd Cir., April 28, 2009) (Order vacating preemption ruling)
33. Brocket v. Wyeth Pharmaceuticals, __ S.W.3d __, 2009 WL 997438 (Tex. App., April 14, 2009)
34.Brocket, 2009 WL 997438 at *7.
35. Stacel v. Teva Pharmaceuticals, 2009 WL 703274 (N.D.Ill., March 16, 2009)
36. Stacel, 2009 WL 703274 at *5.
37. Stacel, 2009 WL 703274 at *4-6.
38. Stacel, 2009 WL 703274 at *6.
39. Id.
40. Levine, 129 S.Ct. at 1198-99 & n.6.
41. FDAAA 2007, Section 355-1(a)(2)(A).
