Execs have known from the Beginning of DePuy ASR Metal-on-Metal Hip Implant ShortcomingsJan 28, 2013
Executives at the Johnson & Johnson subsidiary DePuy Orthopaedics first became aware of widespread problems with its failed ASR metal-on-metal hip implant soon after it was released on the domestic market, a full five years before it was eventually recalled.
This is the latest development, according to a New York Times report, to come from the first trial involving one of the metal-on-metal hip implant’s many victims currently taking place in a Los Angeles Superior courtroom. J&J executives knew that the DePuy ASR hip implant suffered from a flawed design that caused it to shed small metallic particles into the bloodstream and through the body of its recipients.
This defect caused it to fail long before doctors were telling patients the devices would last but despite this information gathered by the makers of the device, the company continued to market the ASR metal-on-metal hip implant for another five years before finally recalling it from the market.
In that time, more than 97,000 people received an ASR or ASR XL metal-on-metal hip implant, all believing the information they were told at the time of their decision to opt for a total hip replacement: that the ASR (a metal-on-metal hip implant) was a revolutionary device designed for younger-than-normal recipients of total hip replacements and that the device would allow them more mobility and last longer than a traditional hip implant.
It did not take long, months in fact, for recipients and their surgeons to realize the sales pitch did not match the results. Severe pain and inflammation along with popping and squeaking at the site of the implant were obvious signs of trouble and soon, many recipients of this device were heading back to their surgeons for revision procedures or to have the ASR metal-on-metal hip implant replaced entirely.
DePuy and J&J were made well aware of these failures with the ASR hip implant as early as 2005 and, according to other information made available at that California trial, the metal-on-metal hip implant had failed internal tests on its efficacy in 2007. The companies withheld that data from the public and continued to market its metal-on-metal hip implant as safe and effective.
Finally, after thousands of reports of the device’s failings, the companies issued a worldwide recall on the ASR line of metal-on-metal hip implant in August 2010. In documents unsealed last week as part of this trial in California, it was learned that DePuy and J&J testing shows that as many as 40 percent of recipients of the ASR devices will experience early failures that will require some form of revision procedure.
On Friday, according to The New York Times, lawyers for the victim in this case provided evidence that the makers of this device conducted internal tests of the ASR, comparing it to other hip implants the companies produce. It continued to search for a device that could not match the performance of the ASR but apparently had gone through numerous attempts until one was found. It was this data, not the failed tests, that DePuy used as evidence for doctors to tell them the ASR was still safe and effective, despite their concerns.
Other evidence introduced shows that the companies planned to “phase out” the ASR line of metal-on-metal hip implants starting in 2009 but did not cite safety concerns; rather, they suggested it was due to slow sales of the devices.