Doctors Say Lawsuits Improve Drug Safety

August 2008

Patients must be allowed to sue the manufacturers of dangerous drugs – this is the message given to the U.S. Supreme Court by leading doctors who edit the influential New England Journal of Medicine. According to these editors, because the U.S. Food and Drug Administration (FDA) cannot guarantee drug safety, patients need the protection of legal recourse against the makers of harmful medications.

This opinion was issued as the case of Wyeth v. Levine approaches, which is expected to be tried before the Supreme Court this fall. Diana Levine of Vermont lost her right arm after she was injected with Phenergan, a drug used to treat nausea. The injection lead to gangrene, and Levine sued the manufacturer, Wyeth, for neglecting to warn consumers that the medication could have such severe consequences.

Ms. Levine won the case in her home state and was awarded close to $7 million. As a result, Wyeth appealed, saying that FDA officials had reviewed the risks and benefits of Phenergan when approving the drug’s prescribing literature.

Earlier this year, the Supreme Court declared that manufacturers of FDA-approved medical devices were not liable to litigation in state courts. Some experts say that because the law in the medical devices case contained a pre-emption provision and the Food and Drug Act does not, the ruling in that case cannot be applied to Wyeth v. Levine.