On June 24, 2013, the Supreme Court reversed a $21 million jury verdict awarded to a woman who suffered serious and debilitating injuries as a result of taking a generic form of the drug sulindac.The name brand version of this drug is Clinoril. Karen Bartlett, the injured plaintiff, began taking sulindac in 2004 for her shoulder pain. She was prescribed Clinoril, but her pharmacist filled the prescription with the generic form of the drug which was manufactured and sold by Mutual Pharmaceutical. Soon after taking the medication, she developed toxic epidermal necrolysis, a closely related disease to Stevens-Johnson Syndrome. The US Food and Drug Administration (FDA) approved a label change in 2005 to add warnings regarding toxic epidermal necrolysis and Stevens-Johnson Syndrome to the label, but this change came after Ms. Bartlett suffered the effects of toxic epidermal necrolysis.
The Supreme Court’s opinion addressed whether or not Ms. Bartlett’s state court design defect claim was pre-empted by federal law. The Supreme Court found that design defect claims that turn on the adequacy of the drug’s warnings are pre-empted by federal law. It went on to note that Mutual had two options in attempting to comply with the state law requirement against the design, manufacture or sale of an “unreasonably dangerous” drug: to change the design of the drug or change the labeling. According to the Court, Mutual could not do either without being in violation of federal law and FDA requirements.
The First Court of Appeals, who upheld the jury’s verdict against Mutual. It held that if Mutual could not change the drug’s design or change the warning label, it could stop selling the drug. The Supreme Court reversed this holding.
See the Supreme Court’s opinion at: