After years of conflict and countless lawsuits filed against it, Johnson & Johnson’s orthopedic unit, DePuy Orthopaedics, is ending production of all metal replacement hips because of “high early failure rates,” according to New York Times author Barry Meier. Meier has been following products from Johnson & Johnson and DePuy for years, reporting the failures and scandals in the industry since the 90’s.
“Whether DePuy will do the right thing for those injured by its products, remains to be seen,” commented Daniel Nigh, an attorney specializing in litigation for those injured by faulty orthopaedic devices with the Levin, Papantonio law firm.
Depuy recalled the Articular Surface Replacement (A.S.R.) device in 2010 after it came to light that the device had a tendency to fail, deteriorating within only a few years – in some cases after only one year. Patients that received the metal-on-metal device often experience inflammation and pain that leads to a second hip replacement surgery called a revision surgery. Most reports estimate that alternative devices, such as those with plastic liners, tend to last as long as fifteen years before the need for revision which stands in stark contrast to the short life span of many metal-on-metal devices. DePuy continued to market some metal-on-metal devices after the recall of ASR. Devices like the Pinnacle model implant were promoted as safe and reliable despite the tendency of similar products to wear at an alarmingly high rate, releasing particles into the patient’s body.
According to DePuy, the decision announced Thursday to end production of the devices is not a response to the dangers the device poses to patients. Instead, the company claims that its decision is one guided by business economics and is not a related to patient safety.
In an interview with Bloomberg, a spokesperson for DePuy said, “We’ve seen, for example, a 90 percent decline in metal-on-metal sales industrywide in the U.S. and Europe since 2007. There’s really not a viable market for these bearing combinations anymore.”
The Food and Drug Administration recently decided that companies which marketed metal-on-metal hip protheses, which were allowed to go to market without proof of prior clinical testing, would now be required to run those studies to keep the products on the market.
Attorneys across the nation have been filing lawsuits on behalf of individuals who have been injured by the DePuy devices and had to have expensive and invasive revision surgeries. Estimates are that more than 10,000 lawsuits have been filed over the ASR devices.
“Even though DePuy is ending production of the metal-on-metal devices, there are still many patients who have suffered with these implants. DePuy’s statement that this discontinuation of sales is purely a business decision and not based on safety concerns continues to reflect the company’s decisions to put profits ahead of patient safety,” Daniel added.
DePuy and Johnson & Johnson face stiff opposition from attorneys as well as health care providers who believe that the companies failed to adequately test and establish safety of metal-on-metal devices. Rather than performing the safety testing required now by the FDA, they have chosen to simply withdraw the products altogether, raising serious questions about whether the companies ever possessed proof of safety.
Joshua is a writer and researcher with Ring of Fire.