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The NAM filed an amicus brief supporting an appeal of a trial court’s ruling that evidence of a U.S. Food and Drug Administration (FDA) medical device 510(k) approval process, which determined a device is safe and effective, may be excluded from evidence in a personal injury lawsuit. After the trial court excluded the evidence, including on the question of punitive damages for egregious conduct, the jury awarded large compensatory and punitive damages. This case is important because manufacturers could be adversely impacted if courts reach liability decisions based on an improper understanding of the principles of safety and effectiveness that underlie each 510(k) clearance. The NAM’s brief argued that Congress and the FDA established the 510(k) process to ensure the safety of medical devices and that evidence of a manufacturer’s conformance with the FDA’s safety standards is essential to a fair determination of product defects and punitive damages. On March 2, 2021, the court agreed, vacating the verdicts and remanding the case for a new trial.