This week, ALF will focus on the hip implant and knee replacement market, including the present status of major lawsuits and multidistrict litigation, and latest news regarding the market trends technological developments in the field.
Thousands of lawsuits are pending in state and federal courts across the United States against hip implant manufacturers given the notorious failure of metal-on-metal hip implants. The U.S. Food and Drug Administration (FDA) cleared metal-on-metal hip implants through its expedited 510(k) process that permits devices onto the market without substantial clinical testing for safety or efficacy. 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.
However, 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).” This condition, known as “metallosis”, leads to the failure of hip implants.
In addition to ALF’s coverage of Stryker’s recall of its LFIT V40 Anatomic CoCr Femoral Heads and recent settlement of its Rejuvenate and ABG II hip implant lawsuits, as well as the $1 billion verdict against DePuy Orthopedics rendered in the third set of bellwether trials in the Pinnacle hip implant multidistrict products liability litigation, here is a summary of the present status of other lawsuits in the United States against defective hip implant manufacturers:
In July 2016, the California Court of Appeals upheld an $8.3 million verdict obtained against DePuy, a division of Johnson & Johnson, by Loren Kransky after he sued DePuy over his metal-on-metal ASR XL hip which failed in less than five years. He had received an ASR hip implant prior to their recall in August 2010. The DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation (MDL 2197) is still pending in the United States District Court, Northern District of Ohio, notwithstanding settlement whereby DePuy agreed to pay $2.5 billion to settle approximately 8,000 lawsuits by United States patients who had hip revision surgery as of August 31, 2013. In January 2017, the New Jersey state court judge overseeing the coordinated DePuy ASR Hip Implant docket, issued its fortieth case management order, extending the discovery end date in a number of cases to September 30, 2017. Over 9,000 lawsuits have now been filed regarding the DePuy ASR implant.
In November 2016, Wright Medical Group announced a $240 million settlement on behalf of its wholly-owned subsidiary, Wright Medical Technology, which ended five years of litigation brought by 1,300 claimants who alleged their Wright hip implants failed anywhere from 150 days to eight years following hip replacement surgery. Under the terms of the settlement, Wright will pay $170,000 to each claimant who were implanted with its Conserve Cup device, and $120,000 to each claimant who received either a Dynasty or Lineage replacement hip. Wright also established a fund to reimburse patients who suffered “extraordinary injury” resulting from the failure of their hip implants. The settlement applied to patients with lawsuits pending in the multidistrict litigation in the United States District Court, Northern District of Georgia (In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation, MDL No. 2329), as well as those included in proceeding in California Superior Court in Los Angeles.
A settlement program between was announced in early 2014 in which certain patients implanted with Biomet’s defective M2a Magnum hip implant system were to receive up to $200,000. Biomet merged with Zimmer in June 2015. Recently, United States District Judge Robert L. Miller, Jr., who presides over the multidistrict litigation consolidated in the United States District Court, Northern District of Indiana (In Re: Biomet M2A Magnum Hip Implant Products Liability Litigation, MDL 2391), released an order disclosing that 93 lawsuits in ere settled in October 2016. Despite this settlement, depositions are ongoing and the admissibility of expert testimony and reports will be litigated through August 2017, with bellwether trials most likely taking place in late 2017 or early 2018.
At least 5,900 product liability lawsuits have been consolidated into theIn Re Zimmer Nexgen Knee Implant Products Liability Litigation, MDL 2272 in the United States District Court, Northern Distirct of Illinois. However, in late January 2017, Zimmer last week won its third bellwether trial after the jury found against the plaintiff, Beverly Jemma Goldin. In the first bellwether trial in November 2015, the jury found for Zimmer given that the plaintiff failed to prove defective design and failure to warn claims. Zimmer also won its second bellwether trial in late 2016 when the judge found that the plaintiff failed to prove that a design defect caused the knee implant to fail.