The Food and Drug Administration has now required a stronger warning label on the antinausea drug Phenergan, or promethazine. This came about because a patient in Vermont received an accidental intraarterial injection of Phenergan in 2000 and subsequently lost her arm. She successfully sued the drug's manufacturer Wyath and received $6.8 million. She complained that Wyath should have placed a stronger warning on the drug's label to prevent the accident. Wyath's position was that the FDA's approval preempted the patient from suing in court. The case made it's way to the U.S. Supreme Court. In a 6-3 decision, the Court ruled that FDA approval does not shield the drug maker from liability.
This raises the question of ultimate responsibility. Is Wyath responsible for somebody accidentally injecting a drug intraarterially? Would any amount of warning have prevented this from happening? Will this stronger warning label prevent a similar incident from happening in the future? I can't think of a single drug that is safe to inject into an artery. Should we put a black box label on all drugs? If an FDA approval does not shield a drug manufacturer from liability of a known side effect, then what's the point of getting FDA approval? The clinic where this patient was injured had settled out of court but of course the attorneys went after the much deeper pockets of Wyath. Wyath has now stopped making Phenergan, one less treatment choice for patients and physicians.