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Patient can’t sue generic drugmaker over labeling — high court

NEWS IN BRIEF — Posted July 8, 2013

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The U.S. Supreme Court on June 24 ruled that federal law preempts state design-defect laws regarding proper labeling of medications.

Karen Bartlett had sued generic drug manufacturer Mutual Pharmaceutical Co. after experiencing injuries as a result of taking the generic form of sulindac, a nonsteroidal anti-inflammatory drug.

She filed suit under New Hampshire’s design-defect law, alleging strict product liability for her injuries. A jury found that sulindac was unreasonably dangerous and awarded Bartlett $21 million in damages, but Mutual challenged the award, arguing that its label at the time met the same standards as the drug’s brand-name counterpart in accordance with federal law. The labeling could not be changed unless approved by the Food and Drug Administration, the drugmaker argued. An appeals court ruled for Bartlett.

The high court reversed that decision. Justices in a 5-4 decision said preventing liability under state law would have required the generic firm to violate federal law to change the labeling. Under a 2011 high court decision in a separate case, federal laws preempt state design-defect claims (link).

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