Earlier this week, we wrote about Johnson & Johnson unit DePuy Orthopaedics and the contention that its A.S.R. hip replacement implant is a defective product. When the A.S.R. was introduced, it was promoted as a major breakthrough, and as an implant that would last much longer than similar products. When the allegations were first brought against DePuy, the company maintained its self-promotion, claiming that surgical mistake was behind patients’ pain and injury, not the product itself. Recently, however, DePuy announced that it is phasing out the A.S.R. device, but not for safety reasons. Instead, the company claims that lagging sales are behind the recall.
Critics of the company and its products and actions claim that the A.S.R. should never have been released due to its lack of proper testing. Yet according to current regulations of the Food and Drug Administration, no such testing is required. The FDA mandates that if a device such as the A.S.R. closely resembles a similar device that has already been approved and placed on the market, no additional testing is required for the new product.
Based on these regulations, manufacturers have discovered a loophole: if a device has been approved, a company can add to it with components from unapproved and potentially defective products, and place the new design on the market with little to no testing. DePuy took advantage of this with the A.S.R. To get FDA approval for the implant, DePuy used clinical data that had helped win approval for a hip implant called the Ultima some five years ago. However, the A.S.R. had a completely different cup design than the Ultima, which ultimately caused harm to many people.
According to Dr. Sidney Wolfe of the Public Citizen’s Health Research Group, the A.S.R. is a prime example of how the lack of oversight can go terribly wrong. “You are basically testing these devices in an uncontrolled way on a large number of people.”
If you or a family member has been injured as a result of medical implants or other devices, please contact Breslin & Breslin for a free consultation.
Source: New York Times, “The Implants Loophole”, Barry Meier, 16 December 2010