Clinical trials play a fundamental role in the development and marketing of medical devices and pharmaceuticals. This webinar will explore recent product liability lawsuits involving clinical trials. These lawsuits generally fall in to at least one of three categories: (1) improper design and/or implementation of the clinical trial; (2) inadequate consent; and (3) notice to the manufacturer of an alleged defect. In addition to product liability lawsuits, non-product liability cases this year have addressed issues pertaining to informed consent regulations and the transparency of clinical trial results. Given the explosion of clinical trials, we expect that litigation will continue to mount, particularly relating to the use in clinical trials of contract research organizations (“CROs”) and data sharing. The webinar also will cover FDA’s recent steps to enhance the transparency of clinical trial data, including its new pilot program to evaluate whether disclosing certain information within clinical study reports improves public access to drug approval information.
