Democratic lawmakers are planning to introduce legislation that would overturn a Supreme Court decision in February 2008 barring injured patients from suing a medical device company if the device had already received Food and Drug Administration FDA approval. In effect, the legislation promises to return patients their right to sue medical device makers for injuries sustained after using their products.
In February 2008, the Supreme Court ruled that injured patients or their survivors could not sue companies that manufactured medical devices that had FDA approval. Since the ruling was passed, judges around the country have thrown out several hundreds of lawsuits that were filed by patients and their families against manufacturers of defective medical devices. Now Henry A Waxman, Democrat from California and Frank Pallone Junior Democrat from New Jersey, have plans to introduce legislation that would overturn the Supreme Court decision. The Supreme Court ruling was based on the premise that approval by the FDA took preemption or precedence over product liability laws in individual states. Judges around the country have cited the Supreme Court decision as the reason for their dismissal of several medical device product liability lawsuits.
Since the Supreme Court ruling was passed, Atlanta product liability attorneys, pharmaceutical injury experts and patients’ advocates have been vocal in their opposition to the law which essentially cuts off individual rights to justice in the event of an injury. It is important to understand how serious some of these injuries are. Defective Medtronic defibrillators have resulted in a massive shock being delivered to patients’ heart, and there have been other serious injuries including burning and scarring injuries caused by malfunctioning joints and other devices. These injured victims used devices that were approved by the FDA, but can hope for little justice as long as the Supreme Court decision rules. The FDA has time and again failed in its duty to make sure that medical devices entering the market are free of defects. It has severe critics both within and outside the organization who are concerned about botched approval procedures, and even corruption at the agency. If the new Democrat-sponsored legislation passes, patients can hope for justice again.