Plaintiffs’ Attorney Group Comments on Proposed FDA Approval Process for Metal-on-Metal Hip Implants

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Metal_Metal_Hip_Approval-ProcessOverview: In response to mounting safety concerns and personal injury lawsuits over metal-on-metal hip implants, the U.S. Food and Drug Administration (FDA) proposed that the controversial devices go through a stricter form of approval. Reuters report that the American Association for Justice, a plaintiffs’ attorney industry group, supports the need for a more intensive review process but also expressed concerns that manufacturers may use the proposed change as a way to dodge liability for the thousands of lawsuits filed over the implants.

  • Metal-on-metal hip implants have become controversial due to growing evidence showing that they can release metal particles into the body
  • The FDA has proposed new regulations that would require manufacturers to conduct clinical safety tests before obtaining approval for metal hip implants
  • The AAJ supports these changes, but points out that manufacturers could try to use it to dodge liability clams; the FDA should make sure to prevent this, the AAJ suggests

Product & Manufacturer

Johnson & Johnson/ DePuy Orthopaedics Biomet Smith Nephew Zimmer Wright Medical Technology
ASR (recalled) M2a Magnum Oxinium Durom CONSERVE Hip Systems
Pinnacle   Birmingham BHR   Profemur

 

Side Effects & Complications

  • High failure rate
  • Necrosis (tissue death)
  • Increased levels of cobalt and chromium ions
  • Pain at the implant, sometimes spreading to the groin and back
  • Osteolysis (bone loss)
  • Fluid collections/solid masses around the hip joint

Premarket Approval versus 510(k)

Almost all metal-on-metal hip implants were approved through 510(k), a process that allows devices onto the market without any clinical testing for safety or efficacy so long as the manufacturer can argue that it is similar enough, or “substantially equivalent” to a previously approved product. Many experts consider the 510(k) to be a loophole that manufacturers use to circumvent adequate safety measures. In a letter dated April 18th, the AAJ told the FDA that it supported the agency’s efforts to impose stricter regulations for the devices, but it also expressed concerns that device makers may use the changes to dodge thousands of lawsuits over the implants. “It would be absolutely unfair … if these claims all of a sudden were thrown into jeopardy solely because the government determined that the products needed additional safety testing before being marketed to consumers again,” wrote Mary Alice McLarty, the president of the American Association for Justice to the FDA. The AAJ said it was worried that manufacturers could use premarket approval retroactively to argue that the implants are proven to be safe. The organization urged the FDA to include language in the final rule that would prevent manufacturers from being able to do this.

Metal-on-Metal Hip Implant Lawsuits

There are thousands of lawsuits filed over metal-on-metal hip implants in the United States. The DePuy ASR, which drew attention to the class of medical devices after a high profile recall in 2010,may be the most notorious. Plaintiffs in the litigation allege that the implants are defective due to their metal-on-metal design, which releases a toxic amount of metal debris into the blood. This allegedly causes a series of complications such as soft tissue reaction, metal poisoning and early failure.