If a bill passes in Congress, patients suffering injuries caused by defective medical devices will be able to hold manufacturers accountable in state courts. The new legislation was introduced last month. The Medical Device Safety Act, sponsored by Senator Ted Kennedy in the Senate and by New Jersey Representative Frank Pallone and House Energy and Commerce Committee Chairman Henry Waxman in the House, would restore the right to seek justice for victims of faulty medical devices. These devices would include heart defibrillators, artificial valves, and prosthetic knees and hips. This legislation followed 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. That important decision was discussed in great detail in this issue. The Medical Device Safety Act is needed to restore the right to file suit in state courts to medical device patients.
Prompted by the United States Supreme Court decision last year in Riegel v. Medtronic, the legislation would re-establish that federal law governing medical device approvals does not “modify or otherwise affect” lawsuits brought in state courts. The Riegel decision held that manufacturers of class III medical devices that have been approved by the Food and Drug Administration’s pre-market approval process are essentially immune from liability. That immunity could apply even in instances when a company actually knew that a device was defective and dangerous, and even when the device had been recalled. Linda Lipsen, Senior Vice President of Public Affairs for the American Association for Justice, observed:
You only have to look at these 1,496 individuals to see the real life effects of allowing negligent manufacturers to receive complete immunity for their hazardous products. The Medical Device Safety Act is an important step in restoring accountability to device manufacturers and protecting patients from defective devices that can harm and even kill consumers.
The Government Accountability Office (GAO) reported in January that the FDA has failed for decades to comply with a Congressional mandate and rigorously review class III devices, the riskiest class of medical devices, as covered in Riegel. For example, in a recent five-year period, the FDA required only minimal testing before approving 228 class III, high-risk medical devices, including metal hip joints, defibrillators, and electrodes for pacemakers. Based on findings from its report, the GAO recommended the FDA either issue regulations to reclassify some medical devices or require the more stringent premarket review process.
Source: AAJ Release
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