High Court struggles with drug preemption

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Washington – The U.S. Supreme Court is wrestling with an issue that has pit business groups squarely against trial attorneys. And attorneys on both sides of the issue say much more is at stake than whether a $7 million verdict should be upheld.

“This case, at heart, is a direct challenge to the FDA’s authority,” said Alan Untereiner, a partner at the Washington office of Robbins, Russell, Englert, Orseck, Untereiner & Sauber.

The case, Wyeth v. Levine, considers whether an FDA-approved drug label can be the subject of state-law tort litigation. The Supreme Court heard oral arguments in the case earlier this month.

Robin Conrad, executive vice president of the National Chamber Litigation Center and author of the group’s amicus brief in support of Wyeth, put it a different way: “This case is about leaving regulation in the hands of experts, not placing it in the hands of trial lawyers.”

But the American Association for Justice, the nation’s largest trial lawyer group, has been actively campaigning against pro-preemption policies, arguing that tort actions are needed to ensure that negligence victims have a judicial remedy.

“The U.S. Supreme Court’s decision will have enormous ramifications,” said AAJ president Les Weisbrod in a statement.

Loss of Arm

The plaintiff, Diana Levine, lost her arm in 2000 after being given a dose of the anti-nausea drug Phenergan by “IV push” – a method that injects the drug directly into the vein.

The FDA-approved label indicated that the preferred method was intramuscular injection, and it included a warning that intravenous injection posed a risk of gangrene if the drug was inserted directly into an artery. However, it did not prohibit IV administration of the drug.

Levine sued drug maker Wyeth and her physician. The case against the doctor settled, but a jury awarded Levine a $7.4 million verdict against Wyeth, finding that the labeling was “unreasonably dangerous” because it didn’t state: “do not use this drug intravenously.”

Wyeth appealed, arguing that the plaintiff’s claim was impliedly preempted because the state standard of care conflicted with the FDA-approved label.

But the Vermont Supreme Court affirmed the verdict, holding that it was possible to adhere to both the state standards and the FDA standard because the federal rule established a floor – not a ceiling – for the standard of care.

Skepticism at the Court

At oral arguments earlier this month, some justices, including Justice Anthony Kennedy, seemed skeptical of Wyeth’s argument that it is impossible to adhere to the FDA standards, as well as stricter state standards.

“As a textual matter, as a logical matter I just don’t understand that,” Kennedy said to Seth P. Waxman, the partner at WilmerHale’s Washington office who argued on behalf of Wyeth.

“I think I could design a label that’s completely consistent and that meets the requirements that [the plaintiff wishes] to urge.”

But Waxman argued that it would be impossible to adhere both to the FDA-approved label, which allows IV push, “and also use the label that the Vermont jury [wanted]: ‘You may not, should not use IV push.’”

He also urged the Supreme Court to use the same reasoning as in Riegel v. Medtronic, 128 S.Ct. 999 (2008), where the justices held state tort claims over medical devices were preempted by the Medical Device Amendments of 1976.

But Justice David Souter pressed Waxman on the actions of Wyeth, not the FDA.

“As I understand it, Wyeth could have gone back to the FDA at any time and said … the label ought to be changed to say ‘Don’t use IV push,’” Souter said. “Wyeth could have done that at any time, and it simply didn’t do it.”

FDA Policy on Preemption

Justice Ruth Bader Ginsburg questioned Edwin S. Kneedler, the deputy solicitor general arguing in support of Wyeth, about the reported change in FDA policy on preemption.

“Some of the briefs tell us that this represents a change of policy on the part of the FDA, that in fact the FDA once approved and said torts suits were a helpful adjunct to the FDA’s own efforts to protect consumers,” Ginsburg said. “Was that once the FDA’s policy; and, if so, when did it change?”

“[FDA] has never taken the position that, as a general matter, a manufacturer may change a label without the existence of new information that justifies a revision,” Kneedler replied.

David C. Frederick, a partner in the Washington office of Kellogg, Huber, Hansen, Todd, Evans & Figel, argued on behalf of Levine. He pointed out that the FDA’s own regulations places responsibility on drug makers for policing the safety of products and amending labels as needed.

“[Labeling] shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious risk with a drug,” Frederick said, reading from a FDA regulation. “Wyeth knew or should have known from at least the ’70s that there was a significance issue concerning IV push.”

Justice Antonin Scalia suggested those risks were already taken into account.

“Those risks were set forth on the labeling approved by the FDA,” Scalia said.

“FDA never considered any comparative risks of IV push versus IV drip,” Frederick replied.

“If you’re telling me the FDA acted irresponsibly, then sue the FDA,” Scalia said. “But the labeling made it very clear that the preferred method of administering this medicine was muscular and that there were serious risks involved.”

“But the idea that a label is set in stone for all time misunderstands the way the process works,” Frederick said. “[And] had Wyeth been a reasonably prudent manufacturer over the years, it would have known that the risks of IV push so far outweigh any negligible benefits that it [should] have offered a stronger instruction.”

A decision from the Supreme Court is expected later this term.