According to Bloomberg, Johnson & Johnson may be in the process of negotiating a staggering $2 billion settlement with those who were implanted with a recalled DePuy hip implant, specifically DePuy’s ASR device. Johnson & Johnson’s fourth quarter earnings reflected the impact of the ASR recall lawsuits and the pending litigation for the DePuy Pinnacle as well. Thus far, over 10,000 ASR lawsuits have been filed by implant recipients who suffered serious health consequences as a direct result of the ASR metal-on-metal hip implant.
The ASR was recalled in 2010 after it was shown that this particular all-metal hip implant had much higher-than normal failure rates. Over 93,000 of the ASR hip implants were recalled—over 37,000 in the United States alone. Many implant recipients suffered severe pain, inflammation, bone loss and tissue destruction or death which, in turn, required a potentially risky revision surgery. Other patients suffered metal toxicity when tiny metal shards of cobalt and chromium sheared away from the hip implant during periods of activity, finding their way to the bloodstream. Once in the bloodstream the metal ions continued to build up, leading to serious medical problems including cardiovascular issues, neurological disorders, kidney and thyroid problems, loss of hearing and vision, gastrointestinal disorders, balance issues and even disruption of DNA.
Johnson & Johnson has already committed to increasing their reserves in anticipation of the pending lawsuits.The first DePuy bellwether trial will begin in May, 2013, with the next round slated for July, 2013. There is one DePuy trial taking place in California right now with another in Illinois pending for next month. Presently there are thousands of ASR lawsuits pending in the U.S. District Court, Northern District of Ohio. There are presently millions of pages of documentation associated with the lawsuits with more witnesses being deposed weekly.
While many of the all-metal hip implants have suffered problems, the recalled ASR gave an indication of just how serious the problems were. The ASR, like many of the other all-metal implants, slid under the FDA’s approval process by claiming to be “substantially equivalent” to another hip implant which had already been approved.
While Bloomberg reports that Johnson & Johnson’s settlement offer comes out to roughly $200,000 per injured person, lawyers for those recipients of the DePuy hip implants have thus far rejected the offer in the belief that it is just too low to fully compensate the victims. Settlement talks are likely to continue although a spokeswoman for Johnson & Johnson and DePuy stated that the allegations raised in the lawsuits will be vigorously defended and that the companies believe they acted responsibly regarding the metal-on-metal hip implants. Just a week before, the U.S. Food and Drug Administration asked all manufacturers of metal-on-metal hip implant devices to provide requested data which shows the devices to be safe and effective prior to a continuation of their marketing efforts.