Court Ruling in Drug Labeling Pre-Emption Case Expected to be Narrow
Justices’ questions during oral arguments yesterday suggest the U.S. Supreme Court may issue a narrow ruling in a case that asks whether federally approved drug labels protect pharmaceutical companies from lawsuits over failures to issue adequate warnings.
Mayer Brown partner Andrew Tauber told Legal Times the court’s opinion is unlikely to provide broad guidance in drug labeling cases. Tauber wrote an amicus brief in the case for the Product Liability Advisory Council that supported Wyeth, which made an anti-nausea drug that was administered improperly. The plaintiff, Diana Levine, suffered gangrene as a result, and her forearm was amputated.
Tauber, who watched the oral arguments, predicted the court will issue a narrow ruling granting pre-emption “where there are no allegations that the company withheld information” about potential risks and the Food and Drug Administration rejected a stronger warning label, the Legal Times story says. “They may leave for another day what happens when this kind of information is not presented to the FDA,” he said.
The Wall Street Journal account of the arguments says justice appeared skeptical of arguments by business interests hoping the opinion would provide broad immunity from lawsuits for federally regulated products. “Several justices seemed to be searching for a moderate position, whereby private lawsuits might be permitted in extraordinary circumstances,” the story says.
The New York Times says many justices appeared to accept the idea that FDA approval of drug labeling pre-empted lawsuits, as long as new suits could be filed for a company’s failure to disclose new information about potential risks. The case concerns implied pre-emption. A case last year, Riegel v. Medtronic, concerned the effect of a law’s express pre-emption on lawsuits for injuries caused by medical devices.
The case argued yesterday is Wyeth v. Levine.
