"If the U.S. Supreme Court were in the business of compensating victims of medical error because of the poignancy of their plight, Diana Levine wouldn't be in suspense about whether the justices would rule in her favor," but the court "usually doesn't take cases out of sympathy for -- or hostility toward -- an individual," a Los Angeles Times editorial states (Los Angeles Times, 11/10).

The Supreme Court last week heard opening arguments in Wyeth v. Levine, a case that could determine whether patients have the ability to file product liability lawsuits against pharmaceutical companies in state courts. Levine lost her hand and forearm to gangrene after she received the nausea medication Phenergan through a push IV injection, which is more potent and takes less time to act than a traditional injection but has increased risks (Kaiser Daily Health Policy Report, 11/4). In the case, Wyeth argues that, because "its packaging includes safety warnings required" by FDA, "it (and other companies) shouldn't be sued in state courts if a drug harms someone," the editorial states.

According to the editorial, although "this is a close case, Levine should prevail," not "because of egregious misconduct by Wyeth" but because the Vermont Supreme Court decided that "she was entitled to relief under state law" and that, in "enacting the Food, Drug and Cosmetic Act, Congress didn't explicitly invoke its power to pre-empt state action." The Supreme Court "should rule narrowly and in a way that invites Congress to revisit this issue by requiring the FDA to improve its process for monitoring drugs that pose unreasonable risks," the editorial states, adding, "Only then should Congress amend the act to make it clear that drug manufacturers don't have to design a different label for every state" (Los Angeles Times, 11/10).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

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