02-April-2012

In Pliva v. Mensing, the Supreme Court ruled consumers could not sue generic drug makers for failure-to-warn because these companies did not have control over their labels. This decision has shielded generics makers from product liability suits and caused public outcry, Law360 reported in the article, "FDA Could Make Generics Liable Amid Push to Undo Mensing."

Consumer advocacy group Public Citizen petitioned FDA in August to allow generic drug makers to change their labels more quickly to disclose previously unknown safety risks. The American Association for Justice supported the petition, pointing out that 70 percent of prescriptions filled in the U.S. are for generic drugs. One of FDA's primary objectives is to ensure uniformity of labeling for the same drug, Law360 reported.

Ralph Hall, a member of the health and biosciences team at FaegreBD Consulting, commented that new warnings added haphazardly might create new risks for patients. Warnings on antidepressants about suicide risks, for example, might have done more harm than good by stopping depressives from taking the medicine they needed, he said.

"We need to be careful to avoid the law of unintended consequences," Hall told Law360. "Just willy-nilly adding a warning may have negative consequences on patient use of a product."