FDA Stamp on Medical Devices Means Victims Can't Sue in State Court

In 2009, Congress proposed legislation to amend the Medical Device Act of 1976 by enhancing the safety requirements for medical devices. The bill was titled the Medical Device Safety Act of 2009. The amendment came in response to the 2008 Supreme Court decision in Riegel v. Medtronic, which limited state-law claims against medical device manufacturers that have complied with the U.S. Food and Drug Administration's (FDA) strict pre-market approval requirements. While the proposed amendments may be well intentioned, the Act has failed to move beyond committee and public debate.

Medical devices, from catheters to heart valves, have made it possible for many people to have better, richer lives. But even with strict compliance with FDA standards, such devices can result in and have caused injuries. An Evergreen balloon catheter was at the center of the Riegel v. Medtronic matter. The Supreme Court found that, when a company had complied with the FDA's exhaustive inspection and the FDA deemed a product safe, medical device manufacturers were immune from liability under state tort laws. As a result of the Supreme Court's decision, thousands of state actions related to medical device injuries, including those linked to defective defibrillators, were dismissed, and injured people or their families had no remedy under the law to seek compensation or damages.

Since the decision, Congress has sought to restore the ability of injured patients to bring claims against the manufacturers of defective medical devices; however, opponents of the Act argue that amending the law would curb innovation in the medical field and increase medical care costs.

Despite the delays in Congress, the Supreme Court continues to address the issue of preemption. In a 2009 decision in Wyeth v. Levine, the Supreme Court found that premarketing approval by the FDA did not prevent injured patients from suing pharmaceutical companies. The court, while not distinguishing medical devices in its opinion, did find that state tort liability actions offer consumers remedies against drug hazards and that Congress had not intended FDA regulations to preempt state laws regarding damage claims.

In the face of health care and medical malpractice liability reform, the Medical Device Safety Act of 2009 may gain more support and renewed interest in Congress. While the act may restore consumers' abilities to bring state claims for injuries, it may also test the court's and manufacturers' interpretations of federal safety regulations.