Supreme Court Rules Labels Don’t Shield Drug Companies from Suits

The U.S. Supreme Court has ruled that pharmaceutical companies aren’t protected from lawsuits because their warning labels are approved by the federal government.

The court ruled in a 6-3 decision that approval of drug labeling by the Food and Drug Administration does not pre-empt state court lawsuits over insufficient warnings, according to Reuters and the Associated Press.

The BLT: The Blog of Legal Times calls the decision “a major defeat for the pharmaceutical industry.” Justice John Paul Stevens wrote the majority opinion, according to SCOTUSblog.

The court ruled in the case of musician Diana Levine, who was awarded $6.8 million in a suit against Wyeth. She lost part of her arm after an anti-nausea drug made by the company was mistakenly injected into her artery.

Stevens wrote that Wyeth’s pre-emption argument "relies on an untenable interpretation of congressional intent and an overbroad view of an agency’s power to pre-empt state law.”

"In short, Wyeth has not persuaded us that failure-to-warn claims like Levine’s obstruct the federal regulation of drug labeling," Stevens said. "Congress has repeatedly declined to pre-empt state law, and the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight."

Chief Justice John G. Roberts Jr. was among the dissenters. Legal Times had questioned whether he would recuse himself in the case, since he owns stock in Pfizer, which is acquiring Wyeth in a transaction that won’t be completed until July 31.

"This case illustrates that tragic facts make bad law," according to the dissent, written by Justice Samuel A. Alito Jr. "The court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs."

The decision (PDF) is Wyeth v. Levine.

Updated at 2:34 p.m. to correct that Pfizer is acquiring Wyeth.