Holding Generic Drugmakers Accountable

By Cindy L. Nations

UPDATE: March 24, 2014 : Ever since the 2011 Supreme Court ruling in Pliva, Inc. v. Mensing, the American Association for Justice has been working to close the generic drug accountability loophole which largely immunizes generic drug manufacturers from liability for injuries caused by their products. On March 13, AAJ filed comments with the FDA in support of the agency’s rule regarding generic drug labeling. The rule, as proposed, would effectively overturn the Mensing decision by allowing generic drug manufacturers to update their labels with new safety information without prior FDA approval.

AAJ’s efforts calling for accountability and increased safety were supported by more than three dozen members of Congress, a bipartisan group of State Attorneys General and a variety of consumer and health groups. In addition, a consumer petition signed by more than 20,500 people has been sent to the FDA.

(Original: November 11, 2013) – The FDA announced a proposed rule that would allow generic drugmakers to update labels with new information, just like the brand name manufacturers, potentially exposing them to liability.  Most people don’t realize this, but under the current laws, a generic drugmaker cannot be held liable for drug defects or failure to warn about such defects.  This is based on a 2011 U.S. Supreme Court ruling (Mutual Pharmaceutical v. Bartlett, U.S. Supreme Court, No. 12-142) which noted that under current FDA rules, only name-brand drugmakers are responsible for safety warnings.

So, essentially, what is taken by most as a casual decision made at the pharmacy (choosing generic over brand name) could potentially be the difference between someone being able to seek justice for an injury or have no remedy at all.  Since the Supreme Court decision in 2011, Attorney Howard Nations, working in conjunction with the American Association for Justice (AAJ) has met numerous times with key members of Congress and the FDA to discuss this issue and advocate for the rights of consumers.  This recent decision by the FDA is a move in the right direction.