Supreme Court Holds that State Law Tort Claims Regarding Labeling of Generic Drugs are Preempted

In Mutual Pharmaceutical Co. v. Barlett, plaintiff Karen Bartlett alleged that she took Mutual’s generical non-steroidal anti-inflammatory drug, sulindac, in 2004 after her doctor prescribed it for shoulder pain.  She suffered a rare hypersensitivity reaction three weeks after she started taking and she was left severely disfigured with burn-like lesions over two-thirds of her body.  The plaintiff’s action was based upon a design defect theory after her failure-to-warn claims were dismissed prior to trial and the district court rejected the defendant’s preemption defense. A jury returned a $21 million dollar verdict.

On June 24, 2013, the United State Supreme Court overturned the verdict. The Supreme Court, by a 5-4 vote in a decision written by Justice Samuel Alito, held that state-law tort claims against generic drug manufacturers based on the adequacy of the drug labeling are preempted because under the Hatch-Waxman Amendments to the federal Food, Drug and Cosmetic Act, the generic labels must be the “same as” the labeling of the reference-listed drug.  Accordingly, it deemed those state law claims preempted by federal law.

The decision further protects general drug makers, who can no longer be penalized for selling their products in compliance with federal laws.

More information at: Justices block generic drug liability lawsuits

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