Civil and Human Rights

Justices Weigh Pre-emption of State Drug Claims


WASHINGTON – The U.S. Supreme Court appeared to be leaning toward a narrow ruling in a key case argued Monday about whether state tort claims against drug manufacturers are pre-empted by federal labeling regulations.

In what is one of the major cases of the term, the justices are weighing whether plaintiffs can file suit against drug companies in state court over pharmaceutical products if the U.S. Food and Drug Administration has already approved the drug. Wyeth v. Levine, 06-1249.

The pharmaceutical industry and the Bush administration both strongly support a broad interpretation of the drug labeling law, which would mean that FDA approval pre-empts any state claims, in contrast to the practice under prior administrations in which the agency effectively welcomed litigation as an extra safeguard.

If pharmaceutical companies were to win such a ruling, it could be devastating for trial lawyers, who could potentially be denied the opportunity to file drug liability cases in state court.

But, judging by the justices’ questions at oral argument Monday, a narrower ruling restricted to the facts in the case is more likely.

In April 2000, Diana Levine, a musician from Vermont, developed gangrene and lost part of her arm when a doctor injected her with an anti-nausea drug, Phenergan, which is manufactured by Wyeth Pharmaceuticals.

Although the FDA had approved the method of injection used by the doctor, known as an ‘IV push,’ Levine argued in her lawsuit against Wyeth that the agency had erred in doing so because it had failed to correctly balance the risks.

The Vermont Supreme Court upheld the trial court’s $7.4 million verdict in favor of Levine.

During Monday’s argument, justices on both sides of the ideological divide focused on the jury’s specific findings in the case rather than the broad arguments for and against federal pre-emption made in various amicus briefs. The outcome hinges in large part on whether the justices conclude that the jury based its verdict on evidence the FDA had at the time it approved Phenergan or whether it was presented with new information about the risks of the drug. Levine’s attorney, David C. Frederick, maintained that she did have new information, namely that the FDA had failed to adequately weigh the risk of the IV push against other forms of administering the drug intravenously.

Chief Justice John G. Roberts Jr. and the other conservative justices seemed most concerned at the prospect of the jury second-guessing the risk-benefit analysis made by FDA experts when the labeling for the drug was first approved in 1955 and subsequently reviewed several times.

“People can say it’s safe to walk down the sidewalk,” Roberts said. “That doesn’t mean there’s no risk that you get hit by lightning.”

Frederick responded that there was “no way” that the FDA could have made the determination that the IV push was safe if it knew the risks to be “so catastrophic.”

He conceded in a response to Justice Samuel Alito that Levine’s claim would be pre-empted if the FDA had considered the risks and decided to approve the drug anyway.

At that, Justice Antonin Scalia intervened, noting that the label made it clear that the FDA was aware of the risks of intravenous injection.

“If you’re telling me the FDA acted irresponsibly, then sue the FDA,” he added.

Taking the middle ground, Justice David Souter suggested that Levine’s case rests not so much on whether she brought new information to the jury but rather on whether her lawyers had “further information” about the risks of the IV push procedure.

As expected, Wyeth’s lawyer, former Solicitor General Seth P. Waxman, raised the court’s 8-1 ruling in a medical device pre-emption case last term in support of his argument. In that case, the court found that federal law preempts state law when it comes to regulating certain types of devices, Riegel v. Medtronic, 128 S.Ct. 999 (2008).

But, as legal experts have stressed, that case does not foreshadow which way the court will go in Levine because in that instance, the justices could look to legislation that expressly permitted pre-emption. There is no such statutory language in Levine, as Roberts pointed out.

Elizabeth Wydra, a lawyer with the Constitutional Accountability Center, a liberal legal group, said after the argument that the court seems “inclined to take a narrow view of the case.”

She predicted that a “bare majority” would likely side with Waxman in concluding that the FDA did adequately consider the risks of the IV push procedure.

The argument came just days after the House of Representatives’ Oversight and Government Reform Committee, chaired by Rep. Henry Waxman, D-Los Angeles, issued a report detailing how career FDA staff were opposed to the Bush administration’s decision to aggressively argue for increased federal pre-emption.

In another case argued Monday, the justices pondered a 9th U.S. Court of Appeals decision in which it struck down an Idaho law that bans unions from making payroll deductions from local government paychecks. Ysursa v. Pocatello Education Association, 07-869.

The 9th Circuit concluded that the law violated the First Amendment rights of the employees. Several of the justices appeared to have a problem with the fact that the law only applies to local government employees, with Justice Stephen Breyer suggesting at one point that the case should be remanded back to the District Court for further review.


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