WASHINGTON – The Supreme Court ruled in favor of consumer rights Wednesday when it rejected claims from a drug manufacturer that federal approval of its Phenergan anti-nausea drug should have protected it from lawsuits like the one filed by a Vermont woman.
Diana Levine was awarded a $6.7 million settlement after she lost her arm because of a botched injection of the anti-nausea medication, but Wyeth Pharmaceuticals appealed the award – claiming its label comported with all Food and Drug Administration rules and should be exempt from state level lawsuits.
In a 6-3 ruling on Wednesday, the majority opinion authored by Justice John Paul Stevens ruled that federal laws administered by the FDA do not preempt Levine's successful lawsuit filed under Vermont state law. The jury in that case said Wyeth's Phenergan label did not adequately convey the dangers associated with the drug in violation of state labeling laws.
The ruling is the second this term in favor of consumers looking to file lawsuits against businesses in state court. In December, Stevens also authored the opinion that Maine residents could use state laws to sue tobacco companies for their labeling and marketing practices.
"Oh, my God. I'm so, so happy. I can't believe this phone call," Levine told the Associated Press. "I've been waiting for so long, and I had no idea of what the chances were. I'm just ecstatic."
Stevens affirmed the jury's conclusion that had an adequate warning label been in place, Levine's injury would not have occurred. He wrote that even though the FDA approved the label that was actually in place, "it is not impossible for Wyeth to comply with its state and federal law obligations..."
Stevens went on to write that Wyeth could have unilaterally changed its label and still be in accordance with FDA rules. He declared that the ultimate responsibility for proper labeling rests with the manufacturer—not the FDA. "It is a central premise of the Food, Drug, and Cosmetic Act and the FDA's regulations that the manufacturer bears responsibility for the content of its label at all times," Stevens wrote.
Justice Samuel Alito in said "this case illustrates that tragic facts make bad law." He was joined by Chief Justice John Roberts and Justice Antonin Scalia in calling the ruling a "frontal assault" on the FDA's authority to regulate the drug industry.
Wyeth issued a statement saying it fully complied with federal law and regrets that the Supreme Court disagreed with its position. "The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product's label."