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FDA-based Failure-to-Report Claims

July 29, 2025 (1 min read)

This practice note helps attorneys representing drug and medical device manufacturers advise their clients about liability risks associated with their products, by summarizing the legal landscape surrounding FDCA-based failure-to-warn claims, providing a state-by-state analysis of related common-law duties, and identifying states that recognize FDCA-based failure-to-report claims as a cause of action along with practical insights into the case law of those that do not.

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