A few weeks ago, the House passed a dangerous Bill – HR 1215 – that would severely limit the rights of people who have sustained an injury because of a defective medical device. Now, a new deal between the Food & Drug Administration and medical device makers is making its way to Congress – a deal that, if enacted, would allow the manufacturers of dangerous and defective devices to delay informing the FDA if something goes wrong with their products.
The New York Times reports that “The current draft [of the deal] compels the F.D.A. to speed medical devices onto the market — and into patients — faster than ever. But, at a time when the F.D.A. acknowledges that medical device mishaps are vastly underreported, a provision in the bill says the agency should permit companies to report malfunctions every three months, rather than the current practice of submitting reports within.”
Injuries and deaths related to defective or malfunctioning medical devices are not subject to the delay; those must still be reported quickly, as per the Times.
This is not the time to cut back on oversight
The FDA has always conducted “postmarket safety oversight” – i.e., the monitoring of reports of potential malfunctions, defects and, also, successes – for medical devices. The ultimate goal is to ensure that adverse events (injuries, illnesses, deaths) are avoided, and, in cases where avoidance was not possible, addressed as quickly as possible, to eliminate any future problems. To cut back on this oversight now would be a grave error; one former data worker for the agency told the Times “There are approximately 65,000 new adverse events every month, and you don’t have enough analysts to review those reports.” This new rule might alleviate some of the burden, but with 65,000 reports per month, the response should, perhaps, be more oversight by more individuals, not a rollback of current procedures.
Another way of pushing for tort reform
The medical device industry is worth $148 billion. That makes for a powerful lobby – more powerful than almost anyone can grasp. Post-market safety oversight is what led to consumers discovering that their transvaginal mesh, their artificial hips and knees, their pacemakers and their breast implants led to serious, even life-threatening injuries and illnesses.
The new rule benefits manufacturers and puts profits over people. Victims continue to pay the price for corporate greed.
At Plaxen & Adler, P.A., we do not take such actions lightly. We will continue to fight on behalf of those who have been seriously injured by faulty or defective medical devices. For more than 30 years, we have protected the rights and futures of Maryland families; we don’t plan to stop now.