Fierce Medical Devices has;Witness: J&J Lowered Own Standards To Deem Metal Hips 'Safe'
January 29, 2013 | By Damian Garde
When Johnson & Johnson's ($JNJ) metal-on-metal hip implants failed an internal safety test, the company opted against fixing the issue and instead just changed its protocols, a witness testified in one of thousands of lawsuits the drug and device giant now faces.
As Bloomberg reports, a biomedical engineer told the court that J&J had ample opportunity to fix problems with its now-recalled ASR hip implants, and another witness testified that the device had a 44% failure rate over 7 years, citing Australian data.
J&J has already spent about $900 million to argue and settle suits since the ASR's 2010 recall, but analysts expect the 10,000 lawsuits now pending could cost the company billions.
And this week's testimonies did little to quell the bad press around the issue. Magnus Flett, who led the ASR design team, told the court that the company decided not to redesign the implant for financial reasons, Bloomberg reports, and J&J didn't tell surgeons that ASR failed nearly 8 times as often as other devices because "I don't believe that was clinically relevant."
The plaintiff in the case claims that his ASR implants failed to spur bone growth and abraded to deposit dangerous cobalt and chromium into his bloodstream. J&J contends that it followed procedure in getting FDA clearance for the tech, which the company maintains was not defective.
Meanwhile, J&J is dealing with mounting litigation over Pinnacle, its other, not-recalled metal hip implant. That device is said to fail at a rate of about 10%, which, while below the ASR, still exceeds what's commonly accepted by manufacturers.
And Johnson & Johnson isn't the only devicemaker facing all-metal-hip fallout. Stryker ($SYK) spent about $133 million to deal with its implant recall last quarter, and the company says the whole fiasco could cost $390 million before it's resolved.
None of this has escaped the notice of the FDA, which is proposing a sweeping change in its all-metal hip regulations, requiring manufacturers to prove the safety of their commercialized implants or have them yanked from the market.
- read the Bloomberg report
Report: J&J knew of hip failure years before recall
FDA wants feedback on tighter hip-implant regs
J&J back in court over DePuy hip implants
Thank You Fierce Medical Devices and Mr Garde
J&J Study Predicted 37% Hip Replacement-Failure Rate