Injured victims of negligence by drug manufacturers and manufacturers of other products attempt to stop lawsuits by individuals injured as a result of a defective component of the product or the failure to advise the public of defects in a product by asserting a
Federal "Preemption" Doctrine . For instance, manufacturers of breast implants, orthopedic devices and numerous other products from drugs to automobiles claim that they should not be subject to lawsuits, even if their product was defective and caused an injury, because it was approved by the Federal government.
Trial lawyers argue that approval by the Federal government sets forth a minimal standard for a product but it may be based on incomplete, or inaccurate documentation and is almost always based on a historical sample, much smaller than that of the population once the product gets sold. Accordingly, regulatory agencies do not have all the information available to assure the complete safety of a product. That is why Federal agencies frequently require follow-up information.
Congress and the Courts, including the Supreme Court of the Unites States, have recently dramatically reduced the ability of manufacturers to rely on the Federal Preemption Doctrine as a defense to a claim of negligent design or defect causing an injury. This opens the door to justice for those individuals injured by defective products without having to confront the improper and artificial defense of preemption.