As public awareness of problems with artificial hips and other medical implants increase, legislation was introduced in the Senate that would force manufacturers to track the performance of such products after they were approved for sale.
The bill would allow the Food and Drug Administration (FDA) to compel companies to track medical implants.
The bill is to address the controversial 510(k) process that the FDA uses to clear the sale of certain implants like artificial joints. To sell a new product under 510(k) process, a producer need only show that it is “substantially similar” to a product already on the market.
Thousands of the all-metal hips that are now failing prematurely in patients were approved through the 510(k) system. The new proposal would not require added premarket testing of such implants but would broaden the F.D.A’s postapproval oversight by giving it the authority to mandate that companies collect data on device performance.
Along with introducing the bill, the bill originators sent letters to five major producers of medical devices seeking documents about how they track product safety and recall devices.
The companies were Johnson & Johnson, an artificial joint maker; Zimmer Holdings, another producer of artificial joints; Medtronic, a heart and spinal implant producer; Boston Scientific, a heart device maker, and C. R. Bard, a surgical implant maker. All of these companies have had problems with defective medical products, leading to recalling them.
Specifically, in the case of Johnson & Johnson, Congressional investigators want to know when the company was warned that one of its all-metal hips — the ASR, or Articular Surface Replacement — was failing and how it tracked those problems. Last year the DePuy division of Johnson & Johnson recalled the device after it had been implanted in some 93,000 patients worldwide, including 40,000 in this country.
As of early October, about 3,500 lawsuits have been filed against Johnson & Johnson in connection with the ASR, and medical studies suggest that the ASR may have already failed a few years after implant. Artificial hips are supposed to last 15 years or more before requiring replacement.
Last month, a legislative panel in Australia issued a report that concluded that Johnson & Johnson was probably aware of serious problems with the ASR well before recalling it. The panel also characterized the company’s responses to its questions as “decidedly opaque.”
“Many people could have avoided considerable pain, suffering and diminished quality of life if the company had acted in a responsible manner to known problems with these devices,” the Australian report stated.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.