Johnson & Johnson’s DePuy Unit. In an announcement, health care giant Johnson & Johnson subsidiary DePuy Orthopaedics Inc. has announced it plans to stop selling some of its metal-on-metal hip devices.
The move follows the filing of nearly 11,000 lawsuits over the company’s now-recalled DePuy ASR metal hip implant device. DePuy will discontinue its Ultamet metal-on-metal and its Complete ceramic-on-metal implants, citing low use, competing goods, and proposed changes by federal health regulators, according to a Law360 report.
“The decision to discontinue these products is not related to safety or efficacy, and is not a recall,” the company said in a statement.
The DePuy ASR XL, the focus of thousands of lawsuit, was recalled back in August 2010 following excessively high failure rates. DePuy said that its hip implants manufactured with plastic and ceramic liners will continue to be sold, the Law 360 report indicated.
The Ultamet metal component is most notably used with the DePuy Pinnacle hip replacement system during hip replacement surgeries. The DePuy Pinnacle has been the focus of a number of lawsuits, as well, though it will remain on the market, the company reported.
Mississippi woman’s early revision surgery led her to file a lawsuit against DePuy Orthopaedics
For example, a Mississippi woman’s early revision surgery led her to file a lawsuit against DePuy Orthopaedics over the Pinnacle. The woman alleges she suffered from extreme pain, weakness, and elevated cobalt and chromium levels in her bloodstream due to the device’s defects.
The lawsuit also alleges that the woman was unaware that her injuries were related to her defective metal-on-metal hip implant because the defendants neglected to adequately warn about the risks, and that she would not have had the Pinnacle implanted had she known of them.
The devices, like most metal-on-metal hip systems, were approved with little to no clinical testing because they received approval through the 510(k), which exempts the need for clinical safety and efficacy tests if the manufacturer can prove that the product is “substantially equivalent” to a previously approved device. A device approved under 510(k) rules does not have to be shown to be effective.
The DePuy Ultamet, Complete, Pinnacle, ASR, and other metal-on-metal hip implants have raised safety concerns due to reports suggesting that such devices tend to fail early in the post-operative period. Because of this, the FDA has sought to propose stricter guidelines for the approval process of all-metal hip implants.
The new regulations would require device makers to show that their implants are safe and effective before the products can reach market.
Most recently, the Consumers Union urged the FDA to adopt a proposed rule that would mandate a premarket approval process (PMA) for metal-on-metal hip implants.
If implemented, the devices’ safety and efficacy could be determined before market approval. The Consumers Union asked the federal regulator to reclassify all high-risk implantable medical devices under the PMA process so that clinical evidence will be required to show device efficacy and safety.
The 510(k) process is the most common review path to market for lower-risk medical devices. The metal hip devices, currently classified as low-risk, would not be eligible to bypass clinical testing under the 510(k) if they were to be reclassified as high risk.