Twenty-one plaintiffs claim to have suffered injuries from the DePuy ASR hip implant, which was recalled in August 2010, in a lawsuit filed on June 29, 2012 in Madison County Circuit Court.
Approved by the FDA in 2005, the DePuy ASR hip implant was initially marked as a stronger, more durable option for total hip replacement. This metal-on-metal device places a metal cup against a metal ball and was intended to be a better solution for younger patients. Post-marketing reports, however, indicate that regular wear and tear can cause these components to rub against one another, potentially discarding small metal shards into the surrounding tissues and bloodstream.
The plaintiffs involved in this new DePuy ASR litigation claim to have suffered injuries related to metal poisoning, including tissue loss, bone loss, metal ion release, and neurological injuries. Additional injuries include liver damage and kidney damage. The plaintiffs seek damages in excess of $350,000.
Plaintiffs Claim DePuy ASR Injuries Related to Metal Contamination
According to the complaint filed by lead plaintiff Robert Ball, DePuy Orthopaedics and parent company Johnson and Johnson were aware of the consequences of their hip replacement products, but they failed to warn patients of the risks.
In fact, as early as 2007, the Australian National Joint Replacement Registry notified DePuy of the high failure rate of these devices. In 2008, Newcastle University Hospital concluded that patients implanted with the ASR were at an increased risk for high blood levels of cobalt and chromium. By that same year, the FDA had received more than 300 reports of problems with the implant.
In hindsight, we can see that it was not just the DePuy ASR that put patients at risk. Other metal-on-metal hips like the Stryker Rejuvenate, which was recently recalled, and the Biomet M2A Magnum, have also come under scrutiny lately because of reports of hip replacement problems related to metal contamination. Patients are experiencing pain, instability, premature loosening, and adverse tissue reactions to these devices that were supposed to be superior to older models, but it turns out they may be more dangerous.
Studies Confirm Side Effects from Metal-on-Metal Implants
We are seeing more scientific studies confirming the risks associated with metal-on-metal hip implants. According to research published in The Lancet from the University of Bristol, these implants are more likely to fail than devices made from other materials and should be banned. Scientists determined that 6.2 percent of patients need revision surgery within five years.
New research from the Imperial College in London and Ohio State University published in Chemical Communications confirms that the inflammation in tissue surrounding failing chromium-cobalt implants like the DePuy ASR may be caused by the release of cobalt ions from metal debris that wears away from the device. These ions are known to be genotoxic and could lead to further complications.
DePuy ASR Approved Without Clinical Trials
Critics blame the FDA’s fast-track 510(k) system for allowing the DePuy ASR and other metal-on-metal implants through the approval process without requiring clinical studies. The FDA recently proposed a unique device identification system that is intended to improve the tracking and follow-up of high-risk medical devices. The new system could potentially catch problems more quickly and expedite recalls when necessary.
Meanwhile, lawsuits continue to be filed in courts across the country. The twenty-one plaintiffs in the Wisconsin case come from Illinois, Missouri, California, and Indiana, and they all now suffer lasting damage from injuries related to the ASR. The company withdrew the device in August 2010, but according to the plaintiffs, the device should have been taken off the market much sooner.
DePuy pulled the ASR implant from the Australian market in December 2009, but didn't notify American doctors until March 2010 of the unacceptable failure rates and didn't recall the product from U.S. shelves until months later.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.
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