J&J set aside $2.5 billion last year to settle claims that 8,000 of its DePuy ASR hips were defective. The pharmaceutical and medical device giant company is now exposed to similar allegations that its Pinnacle line of hip implants also were failing prematurely and causing metallosis or metal poisoning.
J&J, the world’s largest health-care company, issued a worldwide recall of 93,000 ASR hip implants in August 2010, saying 12 percent failed within five years. But, according to internal J&J documents unearthed during litigation, 37 percent of ASR hips failed after 4.6 years. In 2012, the failure rate in Australia was 44 percent within seven years.
J&J stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration required device makers to submit new versions of the artificial hips for pre-market approval.
J&J bragged that the Pinnacle metal-on-metal implants, which were approved for sale in the U.S. in 2000, as a design that would last 20 years and offer greater range of motion.
Metal on Metal Manufacturers Face The Music
All metal on metal (MoM) hip manufacturers are exposed to similar allegation of premature hip failure and metallosis. In February 2014, Biomet agreed to settle over 1,000 lawsuits over its MoM M2A Magnum implants. Zimmer has also faced litigation over its Durom MoM device, as has Stryker’s Trident, Rejuvenate and ABG II MoM devices.
Smith & Nephew, which started the MoM craze with its Birmingham line of MoM devices is also under the gun as well as Wright’s line of Conserve MoM hip implants.
There are currently more than 4,000 product liability personal injury lawsuits pending nationwide involving the recalled Stryker Rejuvenate or ABG II implants, which were removed from the market in 2012, amid reports that the modular femoral components may be prone to fret, corrode and ultimately fail within a few years. Stryker announced a billion dollar settlement late last year.
Metallosis Caused by MoM Implants
In many cases, chromium and cobalt debris from the metal-on-metal grinding between the cup and the ball components of the MoM hips caused local muscle, bone, tissue death and increased Cobalt and Chromium blood levels.
According to medical experts the long term side effects of heavy metal poisoning is unclear, with some stating that it can cause bladder and kidney cancer many years down the road.
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