In 2008, the U.S. Supreme Court in Riegel v. Medtronic ruled that a manufacturer could not be held liable if its medical device was defective, even when the device is recalled, as long as the device was approved by the Food and Drug Administration before it hit the market. Medtronic recently issued a recall for malfunctioning pacemakers, the majority of which have been implanted in patients for five years or longer. Last month, the FDA notified affected patients that these defective pacemakers may cause fainting or lightheadedness, and other symptoms associated with an abnormal heart rate. In rare cases, the FDA stated that serious injury or even death could result. More than 21,000 pacemakers have been recalled, and Medtronic is recommending the removal of the affected pacemakers. Under the 2008 Supreme Court decision, Medtronic is protected against liability because the pacemaker was approved by the FDA pre-market.
Congress is now considering legislation entitled The Medical Device Safety Act of 2009, introduced by Henry Waxman (D-CA), Chair of the House Committee on Energy and Commerce, and Frank Pallone (D-NJ), Chair of the Health Subcommittee. The Act seeks to overturn the 2008 Supreme Court decision, and give consumers the right to hold manufacturers liable through product liability lawsuits filed at the state level. Consumers would be able to seek compensation for pain and suffering, lost wages and medical expenses resulting from injuries caused by a medical device, or caused by inadequate safety warnings. The Act would put the safety of consumers first, and eliminate the broad immunity from liability that medical device manufacturers enjoy. Manufacturers would have an obligation and an incentive to ensure the ongoing safety of their products, and not rest on their laurels after FDA approval.
The Medical Device Safety Act of 2009 has the support of the New England Journal of Medicine, the American Bar Association, and the AARP, among others. Senators Ted Kennedy (D-MA), Chairman of the Senate Health, Education, Labor & Pensions Committee, and Patrick Leahy (D-VT), Chairman of the Senate Judiciary Committee, have introduced a companion bill in the U.S. Senate.