In a significant, albeit unpublished, decision, an intermediate appellate court in Pennsylvania has ruled that there is no recognised Pennsylvania common law 'duty' for prescription medical product manufacturers to send 'Dear Healthcare Provider' letters about label changes.
A recent proposed class action involved an alphabet soup of California consumer statutes and common law misrepresentation for four supplements made by the defendant that contained combinations of three chemicals. The gravamen of the complaint was that it was not legal to sell supplements in the United States containing such chemicals, particularly after the Food and Drug Administration had issued a warning letter to the defendant in 2019.
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.
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.