The Supreme Court, voting 6-3, ruled on Wednesday that federal approval of labels giving warnings about effects of drugs does not bar lawsuits under state law claiming inadequate warnings of a health risk.  The ruling came in the case of Wyeth v. Levine (06-1249).  This was the only decision of the day.

The history of the federal law on drugs shows, Justice John Paul Stevens wrote for the Court, that Congress did not intend to bar failure-to-warn lawsuits that are based on state law.  The decision also rejected a claim by the pharmaceutical company, Wyeth, that a 2006 regulation of the Food and Drug Administration expressing concern about the impact of state failure-to-warn lawsuits on federal regulation should mean that such cases are barred.  The Court said that, since Congress has not authorized a federal agency directly to preempt state lawsuits, the Court would give less weight to FDA’s views on that issue.

Justice Stevens stressed, however, that the Court was not ruling on the preemptive effect of any official rule that FDA might impose that had the force of law.  Justice Stephen G. Breyer, who joined the Stevens opinion, made that comment the centerpiece of his separate concurrence.

Also joining the Stevens opinion were Justices Ruth Bader Ginsburg, Anthony M. Kennedy and David H. Souter.  Justice Clarence Thomas wrote separately, supporting only the outcome, not the majority’s reasoning.

Justice Samuel A. Alito, Jr., joined by Chief Justice John G. Roberts, Jr., and Justice Antonin Scalia, dissented.  The dissenters said that the majority had turned “a common-law tort suit into a frontal assault on the FDA’s regulatory regime for drug labeling.”

The case involved a lawsuit over the injection of an anti-nausea drug which Wyeth sells under the trade name Phenergan.  The manufacturer’s label allowed the drug to be administered by direct injection as a highly potent way of delivering the drug to get prompt effects. It also warned that if the drug entered an artery, it could cause gangrene. However, it did not tie that risk to direct injection. That label, and the method of administration, won FDA approval in 1997.

A lawsuit under Vermont law, at the center of Wednesday’s decision, arose when a patient, Diana Levine, went for treatment of a severe migraine headache and associated nausea and dehydration.  She went to the Northeast Washington County Community Health Clinic in Montpelier, Vt., in August 2000.

She was given an intra-muscular injection of Phenargen, but it did not provide much relief.  She returned later in the day and was given a given “push injection” of the drug (as opposed to an IV-drip).  She developed complications from an apparent mistake in the injection, with the drug entering an artery, resulting in gangrene. She ultimately had to have her forearm amputated, ending her career as a musician.

She won a $700,000 malpractice settlement against the clinic, but then sued Wyeth in state court, arguing that the pharmaceutical firm should have revised its FDA-approved label to bar IV-push injections.  A jury ruled in her favor, and awarded $6,774,000.

The Vermont Supreme Court ruled that Wyeth was obliged to comply with a Vermont common law duty not to use a particular form of risky drug administration — here, direct IV injection.

Wyeth took the case on to the Supreme Court, arguing that “there are tens of thousands of individual claims, and potentially millions of class action lawsuits, currently pending in the lower courts, in which plaintiffs contend that a manufacturer’s use of FDA-approved labeling for its prescription drug is inadequate to satisfy state-law duties to warn.”

The Court asked the U.S. Solicitor General for the federal government’s views on the case, and was urged not to hear the case even though contending that the Vermont Supreme Court decision was wrong. But review, the SG said, was not warranted “at this time” because there was no conflict among lower courts on the issue.  The Court nevertheless granted review on Jan. 18 last year, and heard argument in early November.

Posted in Wyeth v. Levine, Uncategorized