The United States Supreme Court is expected to hear the case of Wyeth v. Levine this November which could have far reaching implications as to pharmaceutical litigation cases against drug companies, including those in Illinois and the Chicago area. The legal advice comes from top doctors and editors of the New England Journal of Medicine who have submitted a friend-of-the-court brief. The doctors state that the Food and Drug Administration (FDA) “is in no position” to guarantee drug safety. The doctors went on to to say that lawsuits can serve as “a vital deterrent” and protect consumers if drug companies don’t disclose risks.
The underlying case is about Diana Levine, a Vermont guitarist, who lost her right arm below the elbow after being injected with the drug Phenergen, a medicine used mostly for nausea. She sued the drug manufacturer, Wyeth, contending that the drug company had a duty to warn consumers that injections, like the one she experienced, could have devastating consequences. The state courts in Vermont agreed with Ms. Levine in awarding her nearly $7 million.
But Wyeth appealed stating that it was protected from such lawsuits. It argued that the FDA’s judgment could not in effect be overruled by a state court. FDA scientists had weighed the risk and benefits of Phenergan in approving the drug’s safety literature as a guide for doctors. The FDA was aware of the risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used for this patient.
It has been commented before that the FDA has been the “gold standard” in drug evaluation. The New England Journal of Medicine editors warned the justices to be skeptical in taking such a view now.