Sun Pharmaceutical inflammation, generics news

A decision by the U.S. Supreme Court in Mutual Pharmaceutical Co. v. Bartlett will further restrict the ability of patients to hold generic drug manufacturers liable for injuries. In a 5-4 decision, the Supreme Court overturned a lower court decision that awarded Karen Bartlett over $21 million in damages and found that Mutual's sulindac was "unreasonably dangerous" - the standard for design-defect product liability under New Hampshire law. Bartlett 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. In 2010, the U.S. District Court for the District of New Hampshire 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 (see BioCentury, March 25).

In its decision, the Supreme Court held that federal law requiring generic drug manufacturers to use the same label as the branded drug preempts product liability suits with design-defect claims under state tort law. The court noted that it "was impossible for Mutual to comply with both its state-law duty to strengthen the warnings on sulindac's label and its federal-law duty not to alter sulindac's label." Under current federal regulations, only the branded manufacturer can change a drug's label. ...