Metal-on-Metal hip manufacturers like Johnson& Johnson, Zimmer Holdings Inc., Wright Medical Technology Inc. and Biomet Inc. will likely soon have a choice to make. Yesterday, the U.S. Food and Drug Administration (“FDA”) proposed that the manufacturers of these metal-on-metal implants must prove they are safe in order to continue selling them or before they begin to sell any new metal-on-metal designs. Johnson & Johnson and others are currently facing a massive multidistrict litigations stemming from injuries suffered by implantees who claim these implants generate debris from wear, increase metal ions to toxic levels in the body, and cause tissue damage as well as inflammation causing permanent damage and necessitating revisionary surgery.
This recent proposal by the FDA would mean that manufacturers must pursue approval and risk disclosing deficiencies or exit the market. The prospect of poor study results could cause manufacturers to pull their implants from the market. Under the proposal, the implant makers would have to file either a premarket approval application (known as a “PMA”) or a product development protocol. Most of these implants that are currently on the market have been approved through a much less rigorous FDA approval process.
For more on the FDA’s proposal, see this article.
The DePuy unit of New Brunswick, New Jersey-based Johnson & Johnson (JNJ) recalled 93,000 metal-on-metal hip devices in 2010 after more than 12 percent failed within five years. Wexler Wallace currently represents many individuals affected by defective hip implant systems. If you believe that you or a loved one may be affected by these implants, please contact us here.