S.Ct. holds 6-3 tort suits based on drug labels not preempted by FDA approval

In a 6-3 decision by Justice Stevens, the Supreme Court rejected a drug company’s claim that state failure-to-warn suits are preempted by FDA approval of a drug’s label.

Justice Stevens’ opinion in Wyeth v. Levine was joined by Justices Kennedy, Souter, Ginsburg and Breyer, with Justice Breyer providing a brief concurring opinion. Justice Thomas concurred in the judgment; and Justice Alito was joined by the Chief Justice and Justice Scalia in dissent. --- S.Ct. ----, 2009 WL 529172 (Mar. 4, 2009) (No. 06-1249).

The case involves Diana Levine, a successful musician until she lost her right hand due to an unsafe injection of a potentially toxic drug manufactured by Wyeth. While safe to inject into a person’s veins, the drug causes aggressive and irreversible gangrene if injected into an artery. A physician’s assistant injected the drug into Levine using a method that is likely to penetrate an artery, and a Vermont jury determined that Wyeth was liability for failing to specifically instruct health care providers not to use this unsafe method of injection. The Vermont Supreme Court affirmed, rejecting Wyeth’s claim that, so long as the drug’s label was approved by the FDA, state laws regarding drug labeling are preempted.

In the U.S. Supreme Court, Wyeth first argued Levine’s claim is preempted because it would have been impossible for them to change their labeling and still comply with FDA regulations. As the Court pointed out, however, FDA regulations in effect at the time Levine was injured expressly provided that a drug company may change its FDA approved label to “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product.” 21 C.F.R. § 314.70(c)(6)(iii)(C). Thus, Wyeth’s claim that it could not lawfully change its label conflicts directly with the plain language of the regulation as it existed at the time Levine was injured.

The Court also suggested that Wyeth’s claim would fail even under a 2008 amendment to the FDA regulation. At the urging of the drug industry, the Bush Administration amended the FDA regulation to provide that a drug company may only change its label based on “newly acquired information.”  As Justice Stevens explained, however, such information also encompasses “new analyses of previously submitted data,” and thus Wyeth could have determined based on the fact that at least 20 patients have suffered the same injury as Diana Levine that “a stronger warning” was warranted. In a possible hint that the 2008 amendment might not survive closer scrutiny, the Court also added that “[w]e need not decide whether the 2008 CBE regulation is consistent” with the FDA’s authorizing statute.

Wyeth’s second claim was that Levine’s suit is preempted because it “interfere[s] with Congress’s purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives.”  As the drug company understands the law, FDA approval of a drug label establishes both a regulatory ceiling and a regulatory floor, and states are not free to depart from the FDA’s judgment that a particular label is appropriate.  The Supreme Court, however, found this viewpoint without merit. Prior to 2006 the FDA expressed the view that state tort law is complementary to its mission, not as an obstacle:

In keeping with Congress’ decision not to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation. The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge. State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.

In other words, the FDA can’t catch everything, and they frequently do approve a drug or a drug label despite as-yet-undiscovered dangers to the American consumer. State tort law is the mechanism to protect American consumers when such a danger results in tragedy.

The Court’s analysis of Wyeth’s second claim was also dismissive of the Bush Administration’s attempts to undermine state tort protections for the benefit of drug companies. In 2006, the FDA inserted language into a regulatory preamble—despite failing to submit this language to notice and comment—which adopts the drug company’s position that FDA regulations create both a floor and a ceiling. In light of the Administration’s failure to submit this preamble to notice and comment, in addition to the fact that the preamble departs from Congress’ view—and that of earlier FDA pronouncements—that state tort law complements the FDA’s function, the Court determined the preamble to be unworthy of deference.

In dissent, Justice Alito embraced the Bush Administration’s and the drug company’s view that FDA approval of a drug label established both a regulatory ceiling and a floor. In Alito’s view, the FDA concluded that, despite the substantial risk that the method of injection used on Levine could result in gangrene and amputation, there are also advantages to using that method, and thus doctors should not be warned away from using it altogether. Justice Breyer’s concurring opinion, and Justice Thomas’ opinion concurring in the judgment, however, may provide the most interesting fodder for future decisions.

Breyer’s single paragraph opinion indicates that he may side with the drug industry should a future Administration promulgate preemptive FDA regulations through the proper administrative procedure. Noting that “some have argued that state tort law can sometimes raise prices to the point where those who are sick are unable to obtain the drugs they need." Breyer concludes that it is “possible” that the FDA could promulgate regulations which preempt claims like Diana Levine’s, although he joins in full the Court’s conclusion that George Bush’s FDA did not validly do so.

Justice Thomas’ opinion argues that the doctrine of obstacle preemption itself should be abandoned, as it allows “this Court to vacate a judgment issued by another sovereign based on nothing more than assumptions and goals that [are] untethered” from federal law.