Several years ago, Vermont guitarist Diana Levine lost her arm and her livelihood to gangrene after a health care provider administered a nausea drug improperly. Levine argued in state court that drug maker Wyeth should have affixed stronger warnings to the nausea drug’s label. A jury awarded her $7 million in damages.
The US Supreme Court hears the appeal next week. Wyeth will argue that the Food and Drug Administration had approved the drug label and that decisions by federal regulators like the FDA should supersede state law on the matter of product safety.
“This case is worth tens of billions to the pharmaceutical industry,” Ms. Levine’s lawyer Richard Rubin told the Wall Street Journal.
The 2008 model of the Supreme Court is among the most pro-business in generations. Even Steven Breyer is on record as strongly supporting FDA primacy in similar situations.
But consumer advocates have reminded the Court that the FDA doesn’t always get things right when it comes to product safety. According to these groups, recent settlements against Eli Lilly (Zyprexa), Merck (Vioxx), and Wyeth itself (fen-phen) suggest that a patient’s right to sue-in state court if need be-may be the most effective means to fight against corporate shenanigans.
Wyeth v. Levine has drawn additional interest as a possible precedent for cases outside health care. What happens for example, when states set environmental or fuel efficiency standards that are tougher than those set by federal agencies? The case could also impact future product liability suits covering the gamut from autos to baby cribs.
Anybody got tickets?