We began speaking in our last post about litigation that has been initiated against GlaxoSmithKline in connection with Zofran. As we noted, the lawsuits accuse the manufacturer of failing to warn patients about the risks the drug presents for pregnant women, which include the possibility of birth defects. The issue we raised last time was what liability may attach to doctors who choose to prescribe medications for an off-label use, as is the case with Zofran as used by pregnant women.
One important point is that prescribing medications for an off-label use is not all that uncommon, and physicians are allowed to do so as long as these prescriptions do not veer into the realm of “research.” The distinction, generally speaking, is that research is characterized by interventions aimed at testing of a hypothesis and ultimately contributing to increased knowledge. In cases where research is being conduct with the off-label use of a drug, physicians must take steps to follow established safety protocol and supervision to ensure safety and effectiveness. Patients must also be fully informed of the risks. Failure to do so opens a physician up to liability.