Over 4,000 DePuy Pinnacle Hip Lawsuits Pending in MDL
While DePuy lawsuit news has largely been directed at the company’s recalled ASR hip implant, another metal-on-metal device has been the subject of mounting litigation. According to a master case list from the U.S. District Court for the Northern District of Texas, there are presently 4,087 DePuy Pinnacle hip lawsuits consolidated in the federal court.
The DePuy Pinnacle implant was launched in 2011, promising active young recipients a more fluid range of motion. Similar to the company’s ASR device, the Pinnacle Acetubular Cup has been linked to severe complications stemming from friction between the implant’s metal components. This friction between the cup and femoral stem can cause the implant to fail, as it erodes and releases toxic metal ions into the surrounding tissue.
DePuy Pinnacle hip implant approved through FDA 510(K)
Allegations raised in DePuy Pinnacle hip lawsuits and those involving the ASR claim the metal-on-metal design is to blame, since both devices have been linked to a dangerous side effect known as metallosis – where tiny particles of chromium and cobalt are shed from the components. In the short-term this heavy metal poisoning often results in chronic pain, swelling and reduced mobility. The majority of patients who experience this complication must then have their hip replacement removed and replaced – a lengthy and risky procedure that entails a longer recovery period. Extensive complications of metal-on-metal hip implants have prompted the FDA to issue a public safety communication advising patients of the unique risks of such devices. In 2013, the federal agency stated that it would require rigorous testing for all future models of hip replacements that had all-metal designs.
DePuy’s Pinnacle hip was approved through the FDA’s “fast-track” clearance system, known as the 510 (k), which allows a manufacturer to sell a new product or medical device without stringent clinical trials as long as it is proven to be substantially similar to another already on the market. The FDA now cautions that recipients of metal-on-metal hip replacements should be regularly monitored for elevated metal ions, soft tissue damage and other complications. Though thousands have labeled the DePuy Pinnacle hip as defective after suffering painful complications, the company has made no announcements in regards to a product recall. The controversial ASR hip implant was pulled off the market in 2010 after DePuy finally acknowledged that the devices were failing at rates of 13% within the first five years of implantation.
Litigation over metal-on-metal hip replacements
DePuy is currently facing litigation in two separate multidistrict litigations (MDLs). More than 7,000 patients have filed ASR hip replacement lawsuits, the bulk of which have been coordinated in the District Court for the Northern District of Ohio. Eligible DePuy Pinnacle hip lawsuits have been centralized in Texas, where the bellwether trials are slated to begin in September 2014. Plaintiffs will be seeking sizeable jury awards or Pinnacle hip settlements as compensation for their medical expenses, lost wages, pain and suffering and other losses. The outcomes of these initial trials may help gauge how future cases will resolve and may encourage DePuy to begin negotiating settlements. Earlier this year, a DePuy ASR lawsuit that went to trial in California state court resulted in an $8.3 million jury verdict for the plaintiff.
Legal analysts speculate that more Pinnacle hip claims will be filed in the coming months, as plaintiffs complain that the device is failing at unreasonably high rates – necessitating early revision surgery and treatment for metal toxicity.