The Supreme Court’s decision in Wyeth v. Levine that held that federal law does not preempt state-law claims with regard to drug warning labels. This decision returned the right to seek justice when an individual has been injured by a pharmaceutical product. The same right should be returned to those injured by a medical device that had been approved by the FDA .
An earlier decision, Reigal V. Medtronic, had held that manufacturers of class III medical devices that have been approved by the Food and Drug Administration’s (FDA) pre-market approval process were essentially immune from liability. The immunity could apply even in instances when a company knew a device was defective and dangerous, and had even been recalled.
“From peanut butter to unsterile syringes, we know the FDA alone cannot adequately police all drugs and medical devices on the market,” said Linda Lipsen, Senior Vice President of Public Affairs for the American Association for Justice. “That is why it is essential the civil justice system provide an added check and balance to strong federal regulations and oversight authority. “ If you or someone in your family has been injured by a fault medical device, seek the assistance of a qualified medical device attorney.
