Brand Name Drug Makers Held Liable for Generic Drug Label Warnings Print
Thursday, September 04 2014

The Alabama Supreme Court recently upheld an earlier decision that found the makers of brand-name drugs liable for the warning labels on the generic version of their drugs.

Citing the theory of innovator liability, the Alabama Supreme Court ruled that, even if the plaintiff only used the generic brand, the brand-name drug maker had potential liability since generic drug makers must provide an exact copy of the warning labels on the brand-name drugs they copy. 

Alabama is the first state to find brand-name drug manufacturers potentially liable.

In 2011, the U.S. Supreme Court decided in Pliva v. Mensing that generic drug makers cannot be held liable through “failure to warn” lawsuits, since such claims are pre-empted by federal requirements that prevent the manufacturers from providing different warnings than are provided on the brand-name version.

According to news reports, the FDA is in the process of finalizing new generic drug label requirements.