The pharmaceutical industry got walloped on Wednesday with a 6–3 Supreme Court decision stating that federal labeling laws do not preempt a drug firm from being sued in state courts.
The case, Wyeth v. Levine, was a much anticipated and closely watched legal battle to determine whether pharma companies could use preemption as a legitimate argument to avoid state-level personal injury suits. In Levine, a Vermont court found Wyeth responsible for the loss of a woman’s arm caused by inappropriate administration of Phenergan (promethazine). The drug firm had to pay the plaintiff $6.7 million in damages.
Representatives for Diana Levine argued that Phenergan’s labeling lacked sufficient warnings, and that the lack of safety information led to the improper delivery of the drug. Phenergan is an antihistamine that is also used as an anti-nausea treatment. Levine was given the drug via IV push, but rather than inject into the vein, the drug was shot into an artery, which can lead to gangrene. The drug’s labeling includes four separate warnings against inadvertent injection into the artery, including a statement in boldface capital letters that reads: "INTRA-ARTERIAL INJECTION [CAN] RESULT IN GANGRENE OF THE AFFECTED EXTREMITY." The plaintiff’s lawyers argued that the warning wasn’t sufficient, and that Wyeth should have contraindicated intravenous use—although FDA had never required such a change, and had even specifically required the drugmaker to retain the language about arterial injection in a review of the label in 1997, a year before Levine’s mishap.
Wyeth’s lawyers argued that FDA makes it so difficult to change labeling after approval that it wouldn’t have been possible to alter. The US Supreme Court disagreed.
“The argument that Levine’s state-law claims are preempted because it is impossible for Wyeth to comply with both the state-law duties underlying those claims and its federal labeling duties is rejected,” the verdict stated. “Although a manufacturer generally may change a drug label only after the FDA approves a supplemental application, the agency’s ‘changes being effected’ regulation permits certain pre-approval labeling changes that add or strengthen a warning to improve drug safety.”
“The decision reflects a clear recognition by the Supreme Court that the responsibility to provide adequate information about the risk associated with prescription drugs lies with the manufacturer and not FDA,” said Jeff Grand, an attorney for Seeger Weiss. “One of the more compelling aspects of the decision was recognition that the manufacturer needs to provide new information about the drugs risk and include not new data, but new analysis of old data. As a safety risk emerges, it’s the responsibility of the drug companies to provide that information to the medical community and the FDA.”
Wyeth wasn’t pleased with the ruling, stating that “lay juries” should not be allowed to “second guess” risk/benefit of drugs of drugs approved by experts at FDA. Wyeth’s prospective new owner, Pfizer, sent the following comment to Pharm Exec.
“Pfizer is disappointed with today's 6–3 US Supreme Court ruling in Wyeth v. Levine,” a Pfizer spokesperson stated in an email. “Pfizer believes that, due to its medical and scientific expertise, the US Food and Drug Administration is the best authority to weigh the benefits and risks of prescription medicines, and to ensure that those benefits and risks are being appropriately communicated in product labels.”
So did Wyeth blow pharma’s last chance to use preemption as a defense in the future? Most of the attorneys interviewed for this article don’t think so.
“This judgment, does not foreclose implied preemption entirely,” said Ezra Rosenberg, partner at Dechert. “This is, as all cases are, a fact-driven decision. “The verdict states on page 15, ‘But absent clear evidence that FDA would not have approved change to Pheragan’s label, we would not conclude that it would have been impossible for Wyeth to comply with both federal and state requirements—Wyeth offered no such evidence.’ Had Wyeth offered evidence that FDA would not have approved a change to the label, the decision could have turned out differently.”
In a surprising turn of events, Justice Clarence Thomas concurred with the liberal majority, albeit for different reasons. Last year, the US Supreme Court found in favor of a drug device manufacturer, stating that a suit against Medtronic was preempted in a case where its balloon catheter burst during a surgery because FDA had approved the device.
“It would have been typical to have been 5–4 with Justice Thomas joining Justices Alito, Roberts, and Scalia,” said Tom Dewey, partner at Dewey, Pegno, and Kramarsky. “One of the strands of preemption that was at issue was that a state lawsuit could be preempted when you cannot comply with state and federal law. Everyone on the court agreed, conceptually, that it was a legitimate basis for preemption doctrine, while disagreeing whether it had been met here.”
Konrad Cailteux, partner with Weil Gotshal's products liability practice, said that he was surprised by the decision. “There was a sense, based on the Medtronic case, that the decision would weigh in favor of industry. In the medical device statute, there is a specific preemption clause that says that states shall enact no laws that supersede or interfere with federal law. The pharmaceutical act doesn’t have that preemption clause, so they are starting from behind.”