Reed Smith LLP updates

We repeat – no second guessing the FDA
Reed Smith LLP
  • Product Regulation & Liability
  • USA
  • 22 October 2020

Pre-emption precludes private plaintiffs from second guessing Food and Drug Administration (FDA) decisions on the marketing and classification of the products that the agency regulates. Defence-side parties should take a close look at a recent case which draws together citations to many cases from different areas of the law that have prevented private plaintiffs from second guessing the FDA, particularly with regard to product liability.

Failure-to-report claims: uphill battle
Reed Smith LLP
  • Product Regulation & Liability
  • USA
  • 08 October 2020

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.

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