Johnson & Johnson, the biggest healthcare product manufacturer in the world, has announced its plan to stop selling its metal-on-metal and ceramic-on-metal hip replacements. The company states its decision is made due to declining demand and in light of U.S. regulators seeking new rules for the products.
In 2010, J&J's ASR metal-on-metal hips were the subject of a widespread recall, due to various defects with the device, including problems requiring the device to be removed or "revised." The ASR recall apparently is unrelated to J&J's decision.
J&J's decision means that metal liners in the Ultamet Metal-on-Metal Articulation and the Complete Ceramic-on-Metal Acetabular Hip System will not longer be sold after August 31. The company also stated that its DePuy Orthopaedics unit (which manufactured the ASR) will stop selling related products through 2014 to simplify and streamline its offerings. J&J has made clear that its decision is not related to effectiveness and is not a recall, although its decision is made in the wake of stricter regulatory scrutiny, increasing safety problems, and a rise in the number of lawsuits over metal-on-metal hip products.
Since 2010, doctors and regulators have publically expressed concern over the numerous defects associated with metal-on-metal hip articulations that have caused serious injuries to patients, including tissue necrosis, pseudotumors, and metallosis, or metal toxicity in the blood, all of which typically require surgical removal of the device.
J&J spokespersons have stated that there has been a 90 percent decline in metal-on-metal sales in the U.S. and in Europe since 2007. J&J will continue to market other hip replacement products, however, including the Pinnacle Acetabular Cup System, and a wide range of liners and cups made with non-metal materials, including ceramic and plastic.
J&J is all too familiar with the problems associated with metal-on-metal hips, particularly since its Depuy unit's ASR was recalled. The company is facing over 10,000 lawsuits related to the ASR and lost its first jury trial this past March.
Most of these products, in fact, most metal-on-metal products on the market, are approved by the FDA through the less intensive 510(k) process, which allows a manufacturer seeking approval of a new device to base its safety and efficacy claims on prior, predicate devices already approved.
In January, the FDA announced it is requiring hip products approved under the 510(k) process to undergo more rigorous studies typically required for entirely new devices. The FDA's decision is the most recent in a string of safety alerts and new requirements concerning metal-on-metal hips.
The defective device attorneys at Jones Ward are evaluating a variety of metal-on-metal hip cases. For more information, contact attorney A. Layne Stackhouse at email@example.com.