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Product Regulation & Liability

08 October 2020
James Beck Failure-to-report claims: uphill battle

USA - Reed Smith LLP

Most of the controversy in the recent decision in Hill v Bayer Corp revolved around whether the plaintiff could assert a cause of action for failure to report adverse product events to the Food and Drug Administration (FDA). The plaintiff's chief problem was that the contraceptive device she was suing over was FDA pre-market approved, thus providing the defendant with a strong pre-emption defence.

Author: James Beck
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