Tag Archives: Medical Device Amendments to the Federal Food Drug and Cosmetic Act

LASIK patients can’t sue over ‘off-label’ uses

Eye surgery patients could not pursue product liability claims based solely on their doctors’ “off-label” use of laser medical devices to perform their procedures, the 9th U.S. Circuit Court of Appeals has ruled in affirming a dismissal.

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Medical device claim not preempted

Federal law does not completely preempt state law failure-to-warn claims against the manufacturer of a medical device used to treat excess uterine bleeding, the 5th Circuit has ruled in reversing a summary judgment.

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