Supreme Court tosses NH woman’s ‘tragic’ drug case
The U.S. Supreme Court ruled Monday that makers of generic drugs already approved by the FDA cannot be held liable under state law for claims of design defects, overturning Karen Bartlett of Plaistow's $21 million jury award. (UNION LEADER FILE)
In a 5-4 vote, the court ruled for Mutual Pharmaceutical Co, owned by Sun Pharmaceutical Industries Ltd, overturning a multimillion-dollar jury award to a Plaistow woman left disfigured and nearly blind who alleged a generic drug she had taken was unsafe based on its chemical design.
“Today’s court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients,” Michael Carome, director of Public Citizen’s Health Research Group, said in an interview.
Keith Jensen, Bartlett’s lawyer, argued that the risks outweigh sulindac’s benefits and that there are more reports of reactions to the drug than to other similar drugs on the market.
“Because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law, New Hampshire’s warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce,” the majority decision said.
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