On Monday in the Northern District of Texas, two individuals filed a complaint against DePuy Orthopaedics Inc., Johnson & Johnson, and affiliated entities that claimed that the defendants knowingly continue to manufacture, market, and sell a hip implant device that allegedly caused harm, in the form of “debilitating pain” and increased blood levels of certain metals.
The medical device in question, called the pinnacle device, is a Class III hip implant, which means it “operates to sustain human life, (is) of substantial importance in preventing impairment of human health, or pose(s) potentially unreasonable risks to patients,” according to the complaint. Class III devices generally have to undergo a rigorous premarket approval process by the Food and Drug Administration (FDA) to thoroughly vet a product for safety and efficacy, pursuant to the 1976 Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act.
Exceptions to traditional premarket approval exist, however. The complaint notes that devices already on the market before the MDA — “grandfathered” devices — did not have to retroactively undergo premarket approval; additionally, a different approval process is available for products that are “substantially equivalent” to grandfathered devices and devices that already have gone through premarket approval, colloquially known as the 510(k) process. The 510(k) process requires “(s)ubmitters (to) compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims,” according to the FDA. The defendants allegedly did just this for the pinnacle device.
The plaintiffs claimed that the defendants, by way of 510(k), “were able to market the Pinnacle Device with virtually no clinical or non-clinical trials or FDA review of the implant for safety and effectiveness” and proffers that had the defendants conducted clinical trials before it hit the market, they would have known earlier that a “high percentage” of patients implanted with the pinnacle device experiences complications like metallosis, biologic toxicity, the “release of metal particles in the patient’s surrounding tissue,” bone erosion, and tumors, among other effects. According to the complaint, more than 1,300 reports have been submitted to the FDA regarding adverse effects of the device.
Personally, the plaintiff claimed that after a 2008 procedure to receive the pinnacle device implant, she experienced “debilitating pain” in her hip that had been implanted with the device that affected her everyday life negatively; lab tests showed that she has higher levels of cobalt and chromium in her blood as a result of “friction and wear” between the metal device parts, according to the complaint. Because of this, the plaintiffs believe that many other recipients of the pinnacle device implant have heightened levels of cobalt and chromium.
The plaintiff underwent surgery to remove the implant; however, revision surgeries are not without their disadvantages, the plaintiffs note, including the now-increased risk for hip dislocation and added recovery, pain, and discomfort.
The plaintiffs specifically allege negligence, violations of strict product liability regulations, breach of express warranty, breach of implied warranty and merchantability, and a violation of the Virginia Consumer Protection Act of 1977, among other causes of action, and they request relief for “both economic and non-economic losses,” such as medical costs and pain experienced, and other reasonable relief.
The plaintiffs are represented by Salsbury Sullivan LLC.