SCOTUS hears preemption oral arguments

Comments from the U.S. Supreme Court Justices at Tuesday's oral arguments for Mutual Pharmaceutical Co. v. Bartlett suggest that if the Justices side with lower courts, both branded and generics companies could be liable for adverse events not expressly stated in a drug's warning section.

The case concerns Karen Bartlett, who developed Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in 2004 after receiving the generic NSAID sulindac manufactured by Mutual, now URL Pharma Inc. and part of Sun Pharmaceutical Industries Ltd. (BSE:524715; NSE:SUNPHARMA). In 2010, the U.S. District Court for the District of New Hampshire awarded Bartlett $21 million and ruled that Mutual's sulindac was "unreasonably dangerous" because SJS and TEN were only listed in the adverse reaction section of the drug's label and should have been explicitly stated in the drug's warning section. ...