JUNE 25, 2013

 - The U.S. Supreme Court ruled today in Mutual Pharmaceutical Co., Inc. v. Karen Bartlett that manufacturers of generic drugs approved by the U.S. Food and Drug Administration ("FDA") cannot be held liable under state law for claims of design-defects.  In a 5-4 vote, the Court ruled in favor of Mutual Pharmaceutical Co., Inc., ("Mutual") overturning a $21 million dollar jury award to a badly injured patient in New Hampshire who alleged a generic drug she had taken was unsafe based on its chemical design. 

In 2004, Karen Bartlett ("Bartlett") was prescribed Clinoril, the brand-named version of the nonsteroidal anti-inflammatory drug sulindac, for shoulder pain.  She was dispensed a generic form of sulindac manufactured by Mutual.  She soon developed an acute case of toxic epidermal necrolysis, resulting in burns over two-thirds of her body.  Bartlett spent months in a medically induced coma, underwent more than a dozen eye surgeries and is now legally blind.  At the time Bartlett was prescribed sulindac, the drug's label did not specifically refer to toxic epidermal necrolysis, but did warn of "severe skin reactions" and "fatalities."  Toxic epidermal necrolysis was, however, listed as a potential adverse reaction on the drug's package insert.  

Bartlett sued Mutual in New Hampshire state court, and Mutual removed the case to federal court.  Bartlett initially asserted both failure-to-warn and design-defect claims, but the failure-to-warn claim was dismissed prior to trial.  After a two-week trial on Bartlett's design-defect claims, a jury found Mutual liable.  The Court of Appeal affirmed.    

The Federal Food, Drug, and Cosmetic Act ("FDCA") requires drug manufacturers to obtain FDA approval prior to marketing any brand name or generic drug in interstate commerce.  Once a drug is approved, a manufacturer is prohibited from making any major change to the formulation or specifications provided in the approved application.  The FDCA requires generics to be essentially the same as the brand name counterparts, thus generic manufacturers are prohibited from making any unilateral changes to a drug's label. 

In 2011, the Court decided in Pliva, Inc. v. Gladys Mensing that the federal laws governing the labeling of generic drugs preempt state laws concerning a generic drug manufacturer's responsibility for warnings on its products.  The Court's ruling today builds on the decision in Pliva, further restricting lawsuits against generic drug manufacturers for design-defect claims.  "[W]e hold that state-law design-defect claims that turn on the adequacy of a drug's warnings are preempted by federal law under Pliva."    

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