California Supreme Court to consider whether brand name drug manufacturer can be liable for injuries caused by inadequate warning in equivalent generic drug

A few years ago I reported on a decision by the Alabama Supreme Court holding that a brand name manufacturer could be held liable for injuries related to inadequate warnings when the plaintiff used a generic version of the drug.  The logic behind this reasoning, which has since come to be known as "innovator liability," is that federal law bans generic drug manufacturers from altering the warnings provided by the brand-name manufacturer (aka the "innovator") even if the generic manufacturers are aware that the brand name drug warnings are inadequate.  Thus, if the warning on the generic is inadequate, it is the innovator's "fault." 

Another reason for the development of this liability theory is that, as a result of the inability to independently alter the warning labels, generic drug makers are essentially immune from liability as long as they used the same warning as the innovator. As a result, those injured by generic drugs have been left with no recourse. Here is a discussion of the issue.

The Alabama decision was overridden by the state legislature last year, but the issue is back in the news because earlier this month the California Supreme Court granted review in a case on "whether brand name drug manufacturers should be held liable for failure to warn about risks associated with their medications when injuries are caused by generic equivalents."


Stay tuned.