Years ago, Vermont guitarist Diana Levine lost her arm and her livelihood to gangrene after a health provider administered a nausea drug improperly.
Levine argued in state court that drug maker Wyeth should have affixed stronger warnings to the drug’s label.
Wyeth countered that the FDA approved the drug label and that should preempt state law.
The jury awarded Levine $7 million.
Wyeth appealed to the Supreme Court and last week, the Court ruled for Levine by a score of 6-3.
Writing for the majority, John Paul Stevens said that “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”
He added the FDA has “limited resources” with which to regulate the 11,000 or so drugs on the market.
“State tort suits…provide incentives for drug manufacturers to disclose safety risks promptly,” he added.
The decision amounted to a righteous whuppin’ for Big Pharma, which knew a positive ruling could short circuit a world of trouble in state courts where thousands of patients allege they have been harmed by more drugs than most can count.
In a conference call, Levine said the verdict brought her “unrestrained joy,” according to the Washington Post. “Next to getting my hand back, it’s the best they could do.”
Joining Stevens in support of Levine were Stephen Breyer, Ruth Bader Ginsburg, Anthony Kennedy, David Souter and Clarence Thomas.
Samuel Alito dissented, saying the case, “illustrates that tragic facts make bad law. 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.”
“And the FDA conveys its warnings with one voice, rather than whipsawing the medical community with 50 (or more) potentially conflicting ones.”
“After today’s ruling, parochialism may prevail,” Alito predicted.