Johnson & Johnson’s orthopedic device unit announced this week that it would begin phasing out the production of the all-metal hip devices that have been the source of a multitude of lawsuits in recent years. The announcement was seen as an important move that reflects a trend in the medical device world of moving away from the once popular all-metal implants due to high failure rates and potential serious negative health effects.
The beginning of the end came in 2010, when DePuy Orthopaedics, now a division of J&J, announced that it would be recalling an all-metal hip implant known as the Articular Surface Replacement, or ASR. DePuy made the move after research indicated the device had an abnormal likelihood of failing after only a few years of being implanted in a patient. This compared with metal/plastic hips that typically lasted 15 years or more before needing to be replaced.
After the initial recall, which impacted tens of thousands of patients, the company continued selling an all-metal version of the hip implant known as the Pinnacle. The company has now said it will begin the process of phasing out the manufacture of all such metal hips, a dramatic change from years past when, at one point, all-metal hips accounted for about a third of all hip implants used in the U.S.
After the explosion in popularity of the devices scientists began finding not only that the devices had a worrisome tendency to fail early on, but also that the all-metal implants could cause other health problems in some patients. Studies found that the metal components in the hips rubbed against each other every time a patient moved which created tiny particles that could then be released in the bloodstream, damaging tissue surrounding the implants.
Johnson & Johnson is now in the midst of handling thousands of lawsuits related to the all-metal implants. Experts believe that more than 10,000 cases related to the ASR implant have been filed in addition to another 3,300 cases related to the Pinnacle. Though patients claim J&J failed to warn them about the danger of the devices, the medical device maker has so far refused to admit that the implants are unsafe. Instead, DePuy says that it decided to phase out the implants because of dropping demand among surgeons and a recent ruling by the FDA that harmed the market for the all-metal hips by requiring manufacturers to undergo clinical testing in patients before they could continue selling them. J&J said that it has informed the FDA it has no desire to submit its all-metal hips to premarket clinical testing and, as such, will stop selling the devices.
If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please contact the Georgia product liability litigation attorneys at Pope, McGlamry, Kilpatrick, Morrison & Norwood, P.C. today to schedule a free consultation.
Source: “J.&J. Unit Phasing Out All-Metal Hip Devices,” by Barry Meier, published at NYTimes.com.
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