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Preemption Play-By-Play From The Supreme Court
By Pharmalot
November 03, 2008
The US Supreme Court sharply questioned Wyeth and a plaintiff over whether FDA regulation of drug labeling prevents consumers from filing product-liability lawsuits in state courts, Dow Jones reports.
During oral arguments in the high-stakes case, the justices probed both sides for the appropriate point at which FDA-approved labeling shields drugmakers from lawsuits. As regular Pharmalot readers know, this case involves Vermont musician Diana Levine, who lost an arm to gangrene caused by an improperly administered nausea drug, Phenergan, which is made by Wyeth.
The Supremes took issue with Wyeth’s argument that it couldn’t update its label to add stronger warnings without first getting FDA approval. “Wyeth could have gone back to the FDA anytime” to update the label, Justice David Souter said. “And it simply didn’t do it.”
Seth Waxman, the attorney for Wyeth, argued the FDA already knew that improperly administering Phenergan through an IV-push method, which happened to Levine, could result in problems and said the drug’s label carried warnings about that.
However, David Frederick, an attorney for Levine, argued the FDA never expressly compared the risks and benefits of one method of administering Phenergan over others, and that the warning on the label was weak. He also argued that the burden is on drugmakers to update their drug labels to ensure they reflect all known risks and benefits.
That argument seemed to trouble Justice Antonin Scalia, who called Phenergan’s label “muscular” and questioned whether the burden was on the FDA, not Wyeth, to ensure the label properly reflected the risks associated with the drug.
Justice Anthony Kennedy asked Frederick under which circumstances preemption should apply. Frederick agreed that if the FDA adequately weighed the risks versus benefits of the IV-push method, and included those findings on the label, then he wouldn’t have a case.
Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
It’s unclear how this court, seen as one of the most business-friendly in 50 years, will rule. A wide array of people and organizations, including the Chamber of Commerce and former FDA officials, have filed briefs in the case.
The FDA favors preemption, which has drawn controversy, because prior to 2006 FDA regulation didn’t mention preemption. Documents released last week by a congressional committee show that officials within the FDA were concerned about the agency’s pre-emption stance, saying it isn’t consistent
