The Supreme Court has upheld a $6.7 million award for a plaintiff who sued the pharmaceutical megacorporation Wyeth. Diane Levine, a Vermont musician, lost an arm to gangrene after receiving a dose of anti-nausea medication to treat a migraine headache.
Levine sued Wyeth in a state court for failing to provide adequate warning of the risks of intravenously administering the drug, the anti-nausea medication Phenergan. A physician assistant who was attending Levine had attempted to administer the drug intravenously and had accidentally inserted it intra-arterially. Wyeth’s Food and Drug Administration (FDA)-approved warning label for the drug stated in bold uppercase letters the risk of gangrene if the drug were accidentally injected intra-arterially. It also stated that the drug could be given intravenously if the intravenous [IV] infusion set was “known to be functioning satisfactorily.”Levine contended, and the Vermont court agreed, that Wyeth was negligent for recommending the use of an IV for Phenergan under any conditions. Wyeth retorted unsuccessfully, first in Vermont and then in an appeal to the Supreme Court, that federal law protected it from indemnity because the FDA had approved the drug’s label and the known risk associated with its infusion injection.
Levine, who made her living as a musician before losing her arm, said in an interview, “[Wyeth] did not minimize the risk… They could have completely eliminated the risk by saying ‘under no circumstances give this anti-nausea drug by means of an IV push.’ If they had done that, I would still…be doing music, playing electric bass, playing guitar, writing songs, and using the piano.”
Dissenting Justice Samuel Alito wrote, “This case illustrates that tragic facts made bad law… [The FDA’s] drug-approval determinations consider the interests of all potential users of a drug, including ‘those who would suffer without new medical
The decision is likely to affect future liability cases against biomedical companies and other groups whose activities physically affect the public. Before suing Wyeth, Levine also won a $700,000 malpractice suit against the physician assistant, her health clinic, and her supervising physician.