Wyeth v. Levine: Important Implications for Drug Manufacturers

The recent Supreme Court decision in Wyeth v. Levine [1] has important implications for drug manufacturers.  In a 6-3 decision, the Court held that the FDA’s approval of drug warning labels for Wyeth’s product, Phenergan, did not preempt state law failure-to-warn claims. 

Summary of the Case

Plaintiff Diana Levine was injected with Phenergan, an anti-nausea drug manufactured by Wyeth, while being treated for a migraine and accompanying nausea.  The clinician injecting the Phenergan used the “IV-push” method, in which a drug is injected directly into a patient’s vein.  The drug entered an adjacent artery, and Levine developed gangrene, requiring amputation of her forearm.

After settling a malpractice suit against the health clinic and clinician, Levine brought a product liability claim in Vermont state court.  She alleged that Wyeth had failed to provide an adequate warning about the significant risks of administering Phenergan by the IV-push method.  The trial court rejected Wyeth’s arguments that Levine’s claims were preempted by federal law because Phenergan’s labeling had been approved by the federal Food and Drug Administration (FDA).  Following a five-day trial, the jury found that Wyeth was negligent and its product defective because of inadequate warnings and instructions.  The court awarded Levine damages in the amount of $7.4 million.  The Vermont Supreme Court affirmed, and the U.S. Supreme Court accepted Wyeth’s petition for certiorari.

In its brief to the Supreme Court, Wyeth made two preemption arguments:  first, that the claims were preempted because it would have been impossible to do what the Vermont jury’s verdict required—modify Phenergan’s labeling—without violating federal law; and, second, that recognition of Levine’s state tort action created an unacceptable obstacle to the accomplishment of the purposes and objectives of Congress in enacting the Food, Drug, and Cosmetic Act (FDCA). 

The Court rejected Wyeth’s first preemption argument—that Levine’s state law claims were preempted because it was impossible for Wyeth to deviate from the wording of the Phenergan labeling that had been previously approved by the FDA.  Specifically, Wyeth argued that a manufacturer may change a drug label only after the FDA has approved a supplemental application based on “newly acquired information.”  The Court rejected this construction of the law and pointed out that the FDA’s “changes being effected” (CBE) regulation permits certain labeling changes that add or strengthen “a contraindication, warning, precaution, or adverse reaction” or “an instruction about dosage and administration that is intended to increase the safe use of the product.”  Under the CBE regulation, Wyeth could have unilaterally added a stronger warning about IV-push administration, and there was no evidence that the FDA would not have accepted such a change.  The Court emphasized that a central premise of the FDCA and federal drug regulations is that the manufacturer bears responsibility for the content of its label at all times.

The Court also rejected Wyeth’s second argument—that requiring it to comply with a state law duty to provide a stronger warning would interfere with Congress’s purpose of entrusting an expert agency with drug labeling decisions.  In advancing this argument, Wyeth relied on the preamble to a 2006 FDA regulation governing drug labeling in which the agency had stated that FDA approval of labeling preempted contrary state law.  The Court rejected these contentions based on several factors.  First, Congress had never included an express preemption provision for drugs in the FDCA, despite numerous congressional amendments to the statute over decades in which it had to have been aware of product liability suits against drug manufacturers.  This was in contrast to the inclusion in the FDCA of an express preemption provision for medical devices.  Second, the FDA’s 2006 regulatory preamble was not a regulation with the force of law.  Third, the preamble reversed, without a reasoned justification, a longstanding agency policy that its labeling requirements provided minimum standards that would not preempt state tort actions.

Implications

The Supreme Court decided Levine under a line of cases that have found certain state laws to be preempted because they conflict with federal law.  Other preemption doctrines—express preemption and field preemption—are unaffected.  In addition, the Court’s reasoning was very specific to the regulatory history of drugs and will not be directly applicable to other federally regulated products.

Following Levine, drug manufacturers will face substantial obstacles in asserting implied preemption as a defense to state law failure-to-warn claims and may see an increase in state tort claims alleging inadequate drug labeling.  However, the Supreme Court did not completely foreclose the possibility of a preemption defense to drug labeling failure-to-warn claims.  The Court concluded its decision by recognizing that “some state-law claims might well frustrate the achievement of congressional objectives” and left open a possible preemption defense under different facts.  The Court also made clear that it was not deciding whether a state court verdict could be based on a contention that a drug label should have contraindicated a use that had been approved by the FDA.

The Court pointed out that there was no regulation at issue in Levine, only the FDA’s assertions in the preamble to the FDA regulation.  Thus, where there is “an agency regulation with the force of law,” that regulation may still preempt conflicting state requirements.  Additionally, the Court held that it was not clear from the FDA’s consideration of the risks related to IV-push administration of Phenergan that the FDA would not have approved a change to the drug’s label.  This effectively puts the burden of disproving the possibility of such a hypothetical FDA approval on the manufacturer.  It also means that where there is “clear evidence” that the agency with expertise on the issue at hand has had real oversight over the specific risk at issue, an implied preemption argument might still be successful.  Even in such a case, the manufacturer will likely need to demonstrate that the FDA has considered and rejected a warning against the particular hazard complained of by an injured drug user.  And it is now considerably less likely that these issues will be decided as a matter of law by a judge; instead, they will be submitted to juries.

Levine is already having an impact.  For example, the plaintiff in Longs v. Wyeth [2] moved the court to vacate a judgment dismissing her claims on preemption grounds following Levine.  The court denied the motion, however, and distinguished Levine on the grounds that (1) the action did not involve a failure-to-warn claim and (2) Levine focused on the manufacturer’s actions post-FDA approval, which gave rise to different duties.  Plaintiffs in In re: Medtronic, Inc. Sprint Fidelis Lead Products Liability Litigation [3] were recently granted leave to amend their complaint to plead claims consistent with Levine.  A federal trial court has held that the reasoning of Levine also applies to generic drugs and declined to find preemption. [4]  And the Supreme Court remanded two cases to the Third Circuit for reconsideration in light of Levine. 

In light of Levine, drug manufacturers should strive to develop a clear record of the FDA’s consideration of the specific risks associated with their products and the agency’s decisionmaking concerning the content of warnings.  Manufacturers should also regularly reevaluate their labeling based on adverse events and, where appropriate, update labeling under the CBE regulations.