The Supreme Court struck a blow to FDA pre-emption of state laws with a 6-3 decision in Wyeth v. Levine finding the company liable for a failure-to-warn claim under Vermont state law.
Writing for the majority, Justice Stevens said Wyeth's argument for federal pre-emption “relies on an untenable interpretation of congressional intent and an overbroad view of an agency's power to pre-empt state law.” Stevens shot down a 2006 FDA statement in support of pre-emption as “entitled to no weight” and contrary to congressional intent, noting that “FDA traditionally regarded state law as a complementary form of drug regulation” and asserting that while the agency has limited resources to monitor marketed drugs, manufacturers “have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.”
“Failure-to-warn actions, in particular, lend force to the [Food, Drug and Cosmetics Act] premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times,” Stevens wrote.
Dissenting were Justices Scalia, Roberts and Alito, who argued that while state tort suits can peacefully co-exist with the FDA's labeling regime, “this case is far from peaceful co-existence” and said “the state-law rule at issue here is squarely pre-empted.”
A Vermont court awarded the plaintiff in the case, a musician who lost her right arm after a botched administration of Wyeth drug Phenergan, $6.3 million in damages. The plaintiff, Diana Levine, argued that Wyeth failed to adequately warn in its labeling of the dangers of administering Phenergan through IV push, which can cause gangrene if the drug is injected into an artery instead of a vein. Wyeth maintains that FDA approval of the drug's label trumps state law.
In a statement, Wyeth called the decision “disappointing, not only for Wyeth, but for patients and public health in general.”
“Patients are best served by a national standard for the labeling of prescription medications,” said the company, “set by the medical and scientific experts at the [FDA]. When lay juries are permitted to second-guess the experts at FDA on the benefits and risks of particular medicines, the result is uncertainty for patients and doctors alike about how and when to use prescription drugs.”
A narrowly framed February 2008 decision in the case of Riegel v. Medtronic established a measure of immunity to common-law claims for medical device manufacturers based on the principle of federal pre-emption. Bolstering the pre-emption defense has been a coveted goal of drug industry lawyers and tort reform activists. Under the Bush administration, the ironclad pre-emption doctrine seemed almost within reach. While President Obama has yet to make any court appointments of his own, this ruling suggests that prospects for pre-emption are fast drifting away.
Industry advocates fear the ruling could open the floodgates to a wave of litigation. “Plaintiff lawyers must be dancing in the streets,” said John Kamp, executive director of the Coalition for Healthcare Communication. “It allows juries to second guess FDA and industry labeling decisions in virtually every failure-to-inform case. Since hindsight is 20/20 always, this decision destroys hopes for a uniform set of labeling and marketing rules. When rules are uncertain, inconsistent and shifting, it's almost impossible to have coherent healthcare policy that uniformly and effectively protect patients.”