Last week, the FDA announced that it lacks critical powers of oversight over medical devices submitted using the “510(k)” or “Pre-Market Notification” (PMN) process, and that it may go to Congress to request additional regulatory authority.
For the last 35 years, the FDA has annually approved approximately 3,500 devices using a 35-year-old law from Section 510(k) of the Food, Drug and Cosmetic Act. 510(k) allows the FDA to determine whether a new medical device is substantially equivalent to a device previously approved, in which case it will be quickly cleared for release onto the market. The program is popular among medical device manufacturers because it is expedient: only 50 or so devices are approved annually under the more rigorous FDA approval system. According to the Government Accountability Office, 20 high risk devices later discovered to be dangerous to consumers were mistakenly passed through the FDA under the 510(k) system last year.
In related news, last week the FDA lifted restrictions on Medtronic external defibrillators, saying that the company had met quality control requirements and could again begin unrestricted shipment worldwide. Medtronic then announced a fourth quarter dividend of $0.205 per share. Medtronic shareholders are on pace to receive over $900 million in dividends this year, while the victims of its faulty devices find their legal claims against the company preempted by FDA approval, and have no legal recourse to recover damages for medicals bills, lost wages, or pain and suffering.
Consumers have faced multiple surgeries due to faulty orthopedic implants, or found themselves shocked by faulty defibrillator leads. However, upon bringing suit, consumers have then found their legal rights nullified by the device’s prior approval by an agency that concedes it lacks the authority necessary to ensure public safety. Circumstances demand speedy legislative action to correct these injustices: passage of the Medical Device Safety Act (MDSA). MDSA would protect consumers’ right to sue when they are harmed by certain defective medical products. As Dr. Larry Kessler, a 13-year veteran of the FDA device center, points out, “The device world codified by the Medical Device Amendments of 1976 is dramatically different than where we are today 35 years later. The pace of innovation has really ramped up and the 510(k) process has been used, and in some cases people would say misused, to clear very advanced technology.”
Help hold device manufacturers accountable: sign our petition urging Congress to pass the Medical Device Safety Act.