iBy now, most mass tort lawyers know that last week, the U.S. Supreme Court dashed the pharmaceutical industry’s hope for a broad preemption defense in failure to warn products liability cases. In a 6-3 opinion authored by Justice Stevens, the Court found that Wyeth’s FDA approved label for its anti-nausea drug, Phenergan, did not provide the company with a complete defense to a plaintiff’s failure to warn claim. This Client Alert reviews the highlights of the opinion and explores the effect this ruling may have on how pharmaceutical companies defend products liability cases and label their products.
Summary of the Case
The facts of the case are now fairly familiar. In April 2000, Levine sought treatment for a migraine headache. She received an intramuscular injection of, Demerol for her headache, and Phenergan, for nausea. When the injections failed to provide relief, she returned to the clinic for additional treatment. This time, however, the drugs were delivered intravenously through an “IV-push.” (Phenergan can be administered intravenously either through an IV-drip or IVpush.) If all had gone well, the medication would have been injected into Levine’s vein. Apparently, the Phenergan was either injected into her artery or came into contact with arterial blood. As a result, Levine developed gangrene and had her right hand and forearm amputated.
The heart of the case was the adequacy of the Phenergan label. Wyeth’s label contained a warning for “Inadvertent Intra-arterial Injection,” explaining that when administering the medication intravenously, care should be taken to avoid injection into the artery or perivascular extravasation (where the drug escapes into surrounding tissue from a vein). Plaintiff, nevertheless, claimed that the label was defective because it failed to warn of the specific risks associated with the IV-push method or to contraindicate it entirely. Wyeth countered that the FDA had approved the label and had rejected prior iterations which strengthened the warnings for inadvertent intra-arterial injection.
Plaintiff brought common law negligence and strict liability claims against Wyeth. (She settled her medical malpractice claims against the clinic, treating physician and physician’s assistant.) A Vermont jury awarded Levine $7,400,000. The trial court denied Wyeth’s motion for judgment based on implied preemption and the Vermont Supreme Court affirmed. The U. S. Supreme Court granted certiorari on the issue of “whether the FDA’s drug labeling judgments ‘preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.’” 2009 LEXIS at *13.
Wyeth advanced two implied preemption arguments; first, that “it would have been impossible for [the Company] to comply with the state law duty to modify Phenergan’s label without violating federal law”; and second, that plaintiff’s claim “created an unacceptable ‘obstacle to the execution of Congress’ full purposes and objectives’ because it substitutes a lay jury’s decision about drug labeling for the expert judgment of the FDA.” Id. at *13-14. The Court rejected both of them.
With respect to the impossibility argument, the Court found that Wyeth could, in fact, have changed/strengthened its warning pursuant to the FDA’s Changes Being Effected (“CBE”) regulations which permit a manufacturer to change its “label to ‘add or strengthen a contraindication, warning, precaution, or adverse reaction’” without waiting for agency approval.” Id. at *22 (quoting 21 C.F.R. §314.70(c)(6)(iii)(A), (C)). CBE regulations permit labeling changes, not only when a company acquires new safety information, but also where “new analyses” of data previously submitted to FDA justify a label change. Id. at *23. Although the record before the Court was limited as to what “new” information Wyeth had acquired about IV-push risks, the Court found significant that plaintiff had presented evidence of at least 20 similar adverse events and that Wyeth “could have analyzed the accumulating data and added a stronger warning about IV-push administration of the drug.” Id. at *24. Therefore, the Court held, it was possible for Wyeth to comply with both federal and state requirements, unless there was “clear evidence that the FDA would not have approved a change ….” Id. at *27-28.
Wyeth’s second preemption argument met a similar fate. The Court found that there was “[p]owerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” Id. at *33. Indeed, it posited that FDA considered “[s]tate law as a complementary form of drug regulation.” Id. at *39. The Court declined to defer to the Preamble in the FDA’s 2006 regulation governing the content and format of prescription drug labels, in which the agency declared that the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §301 et seq., establishes “[b]oth a ‘floor’ and a ‘ceiling’” so that “FDA approval of labeling . . . preempts conflicting or contrary State law.” Id. at *34-35 (quoting 71 Fed. Reg. 3922, 3934-35). The Court found this language to be “inherently suspect” because it signified a shift in FDA policy regarding preemption (since the initial notice of rulemaking in 2000) without providing States or other interested parties with notice or an opportunity to comment. Id. at *38. Having rejected Wyeth’s two preemption arguments, the Court affirmed the Vermont Supreme Court.
Practical Implications
While the full import of Levine will play itself out over time, there are several immediate implications to the ruling.
Defending product liability cases.
For some cases, the loss in Levine will require an immediate adjustment in case strategy. Cases that have been stayed awaiting the Levine ruling will now move forward with alacrity as courts try to clear their dockets. Pending motions for summary judgment on preemption grounds are likely to be withdrawn. Expect the plaintiffs’ bar to use Levine as leverage during settlement negotiations and to push for early trial dates. Defendants will need to regroup and focus on alternative legal and factual defenses.
Is implied drug preemption dead?
Not yet. The Court left an opening for pharmaceutical companies to successfully pursue an implied preemption defense – that is, where there is “clear evidence” that FDA would have rejected the warnings plaintiff claims should have been present in the label. Practically speaking, however, this is likely to be a heavy burden. Nowhere in the Court’s opinion was there a clean definition of what type of evidence would suffice. The Court’s reading of the interactions between Wyeth and FDA regarding the Phenergan label suggests that nothing short of a FDA declaration specifically prohibiting the precise label change advocated by plaintiff will be satisfactory. The meaning and scope of “clear evidence” will be tested in short order. On March 9, 2009, the U.S. Supreme Court granted the petition for certiorari, vacated the judgment, and remanded Colacicco v. Apotex Corp., 521 F.3d 253 (3d Cir. 2008), for further consideration in light of Levine. In Colacicco, the Third Circuit found plaintiffs’ failure to warn claims preempted where FDA took the position that adult suicidal warnings for SSRIs (a class of antidepressants) were not medically supportable. Even under the standard put forth in Levine, plaintiffs’ claim in this case should remain preempted. Colacicco should be an excellent barometer of whether the implied preemption doctrine can still be successfully invoked by pharmaceutical companies.
Effects on drug labeling generally.
Drug companies may find themselves in a bit of a quandary when it comes to label changes. The Levine Court made clear that reliance on FDA approval is not dispositive; rather, “[t]he manufacturer bears responsibility for the content of its label at all times. It 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.” 2009 LEXIS 1774, at *26. We have always counseled our clients to include medically important and supportable information in drug labels and continue to believe that this is the responsible approach. Our clients often use CBE supplements to make responsible label changes. It will be interesting to see whether Levine spawns an influx of CBE supplements, and if so, how FDA responds to them.
Conclusion
Ironically, the day after the Levine ruling, the House Committee on Energy and Commerce introduced the Medical Safety Act of 2009, which is intended to reverse legislatively the Supreme Court’s pro-preemption decision in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). Clearly, the last word on preemption has yet to be spoken. We will continue to monitor post-Levine developments and share our insights with you.
1 Wyeth v. Levine, No. 06-1249, 555 U.S. ___, 2009 U.S. LEXIS 1774 (Mar. 4, 2009).
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