Law Alert!
US Supreme Court Rejects Federal Preemption of
Consumer's State Law Claim Against Prescription Drug Manufacturer
Introduction
On March 4, 2009, the United States Supreme Court ruled that labeling of a prescription drug by the federal Food and Drug Administration (FDA) did not preempt a state law product liability claim for inadequate warning of risks of use. Plaintiff Diana Levine had to have her right forearm amputated after injection of the antinausea drug Phenergan, which was manufactured by Wyeth. Although the drug's FDA-approved label warned that intravenous injection of the drug should be conducted with care to avoid hitting an artery, which could cause gangrene requiring amputation, it did not bar injection of the drug.
Wyeth v Levine: Its Impact for Civil Litigators
By Ken Seeger
The recent U.S. Supreme Court decision in Wyeth v Levine (US S Ct, Mar. 4, 2009, No. 06-1249) 2009 US Lexis 1774 includes something important for almost every civil litigator. We asked one of CEB's Tort Guide authors, Ken Seeger, to comment on the impact that this case will have on civil litigators. Mr. Seeger, of Seeger-Salvas in San Francisco, litigates prescription drug and medical device product liability disputes.
The Court held that FDA approval of a prescription drug warning label does not preempt state law claims that the warning was inadequate. In reaching its decision, the Court rejected three defenses: (1) that manufacturers cannot change their label to add warnings without prior FDA approval; (2) that the FDA, not manufacturers, has primary responsibility for ensuring the safety of prescription drugs; and (3) that allowing juries to find that an FDA-approved warning was inadequate would "frustrate the purpose" of the FDA by upsetting the careful balance that the FDA considers in approving a drug label. This decision has far-reaching effects for all lawyers practicing in the field of prescription drugs.
Impact for plaintiffs' counsel
If you are a product liability litigator in the field of prescription drugs, Wyeth has given you the green light to continue your traditional role as watch-dog by suing those that make and sell defective drugs. By the same token, it has provided a strong incentive for drug manufacturers to ensure that their products are safe.
Moreover, most observers recognize that this decision has broader implications as a repudiation of federal agencies' increasing expansion of the doctrine of federal preemption to nullify state products liability and consumer protection laws.
Finally, although not specifically at issue in Wyeth, regulatory attempts to impose preemption in areas other than prescription drugs received an ominous signal from the Court. In addressing the FDA's position favoring preemption, the Court said that "the weight we accord an agency's explanation . . . depends on its thoroughness, consistency and persuasiveness." 2009 US Lexis 1774 at *37. Under that standard, the Court found that the opinion of the FDA in this case was entitled to "no weight." 2009 US Lexis 1774 at *45.
Impact for defense counsel
Defense counsel will find that Wyeth has left them something to argue on preemption. Defendants will focus on dicta in Wyeth that defendant Wyeth offered "no evidence" that the FDA "specifically disallowed" a stronger warning. 2009 US Lexis 1774 at *2, *9. Accordingly, defense counsel will argue that when the FDA has previously rejected a stronger warning for a drug, state law claims based on this stronger warning should be preempted. For example, in a recent (pre-Wyeth) Third Circuit decision, the court found that the FDA's consistent refusal to require stronger suicide warnings on a drug's labels, both before and after the suicides in question, preempted claims that the stronger warning should have been used. Colacicco v Apotex Inc. (3d Cir 2008) 521 F3d 253.
Note: For background on preemption issues in pharmaceutical and medical device litigation, see California Tort Guide (3d ed Cal CEB 1996), specifically new chap 13.
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