New Suit Alleges Recalled DePuy ASR Metal-on-Metal Hip Implant Caused Metal Poisoning. DePuy Orthopaedics and parent company Johnson & Johnson continue to face lawsuits alleging injuries from its recalled DePuy ASR Acetabular System and the DePuy ASR Hip Resurfacing System, two metal-on-metal hip replacement systems that were subject to a global recall in 2010. The DePuy ASR recall was launched after a higher than expected number of hip implant recipients experienced implant failure within only a few years, prompting them to undergo revision surgery to remove the device.
Parker Waichman LLP represents numerous clients in lawsuits over metal-on-metal hip implants, including the DePuy Pinnacle, the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. The firm, which recently represented bellwether plaintiffs in a trial yielding a $1 billion verdict, continues to offer free legal consultations to individuals with questions about filing a medical device lawsuit.
According to court records, a new DePuy ASR hip implant lawsuit was recently filed on behalf of a South Carolina couple. The lawsuit alleges that the wife suffered various complications, including metal poisoning, after being implanted with the DePuy ASR device in June 2008. The complaint states that she suffered complications in November 2014, when the implant allegedly moved out of place. She alleges implant complications caused fluid buildup and ultimately caused the device to fail. According to the lawsuit, the metal-on-metal hip implant also allegedly caused metallosis, or metal poisoning. The plaintiff cites laboratory test results showing elevated cobalt levels in her blood. Because of these adverse events, the suit states, the plaintiff underwent a revision surgery in March 2015 to remove the DePuy ASR hip implant.
The lawsuit refers to the operative report, which allegedly states that there was fluid in the hip joint, fibrous material in the hip capsule and severe corrosion. The lawsuit alleges that the plaintiff’s injuries were caused by the defective design of the metal-on-metal hip implant and that DePuy and J&J knew about the risks but failed to warn patients or the medical community.
The case joins other DePuy metal hip injury claims in multidistrict litigation (MDL) No. 2197. Federal lawsuits are consolidated in the U.S. District Court for the Northern District of Ohio, Western Division.
DePuy issued a worldwide recall for its ASR hip systems in 2010, citing a high rate of early failure. Although hip replacements are expected to last 10 or 15 years, patients were experiencing complications much sooner, forcing them to undergo revision surgery within a few short years. DePuy ASR lawsuits, as well as other metal-on-metal hip implant lawsuits, allege that the metal-on-metal design of these devices release metal particles into a patient’s bloodstream and tissues, causing adverse events such as metal poisoning, tissue death, pain and inflammation.
Thousands of lawsuits have been filed over the DePuy ASR hip system. The company has set aside roughly $2.5 billion to settle 7,000 ASR hip implant lawsuits. DePuy is also being sued over the metal-on-metal version of the Pinnacle hip implant.
The DePuy ASR recall shed light on metal-on-metal hip implants as a whole and raised questions about medical device regulation. Other metal hip makers, including Stryker and Wright Medical, are also facing metal-on-metal hip implant lawsuits. Plaintiffs in the litigation allege that the hip replacements caused injuries and that the manufacturers knew about the risks but failed to warn patients or their physicians.
DePuy Pinnacle Metal-on-Metal Hip Implant Lawsuits and Verdicts
In addition to the DePuy ASR litigation, thousands of lawsuits have also been filed alleging similar injuries with the Pinnacle Ultamet metal-on-metal hip implant, the all-metal version of the Pinnacle hip system. The litigation has resulted in some large verdicts, including a recent $1.041 billion verdict awarded to six plaintiffs. Parker Waichman helped represent three of the plaintiffs. The case was the third DePuy Pinnacle bellwether trial.
Alleged injuries include the need for early revision surgery, metal poisoning, pain, inflammation, tissue death and bone damage. Plaintiffs alleged that DePuy failed to disclose the risks of the Pinnacle hip device. After hearing arguments at trial, jurors awarded $1.041 billion to the six plaintiffs, including $32 million in compensatory damages.
Attorneys for the plaintiffs argued that DePuy misrepresented the safety of the Pinnacle metal-on-metal hip implant, which was marketed as being a better option over other types of hip implants. Jurors found DePuy and J&J liable for negligent and defective design, negligent failure to warn, strict liability failure to warn, failure to recall, negligent misrepresentation, intentional misrepresentation and fraudulent concealment. The companies were also found to act with malice or fraud.
More than 8,000 lawsuits have been filed into the DePuy Pinnacle MDL. At the conclusion of the second bellwether trial, jurors awarded $502 million to the plaintiff. Due to a Texas law capping punitive damages, however, the award was reduced to $150 million. There was no such cap on the third trial, because it operated under California law.
The next DePuy Pinnacle bellwether trial will reportedly take place in September 2017; Parker Waichman is helping to represent five out of 10 plaintiffs.
Metal-on-Metal Hip Implant Safety Concerns
The U.S. Food and Drug Administration (FDA) cleared metal-on-metal hip implants through 510(k), a process that permits devices onto the market without substantial clinical testing for safety or efficacy. This route is intended for low- or moderate-risk, and not high-risk, devices. Although metal-on-metal hip implants are designated high-risk, manufacturers were able to clear them through 510(k) due to a loophole that temporarily permitted such products through this route.
In 2013, the FDA Orthopaedic and Rehabilitation Devices Advisory Panel warned of “unique risks” associated with metal hip replacements, stating “In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an ‘adverse local tissue reaction (ALTR)’ or an ‘adverse reaction to metal debris (ARMD).'”