DePuy Orthopaedics and Johnson & Johnson have been hit with a hip implant lawsuit accusing the companies of placing a defective medical device on the market that failed for at least 1,300 patients, including the plaintiff, and put them at risk for toxic metal poisoning.
Plaintiffs J. and A. Setter of New York allege in the hip implant lawsuit that Mr. Setter underwent hip replacement surgery in November 2006 and received DePuy’s Pinnacle Acetabular Cup System. He alleges the hip implant prematurely failed, causing him to undergo revision surgery in 2014 and possibly undergo a third revision hip surgery in the future.
The DePuy Pinnacle hip implant lawsuit accuses the defendants of defectively designing the Pinnacle Acetabular Cup System causing it to have a high rate of failure, despite marketing the device as having significant advantages over other hip replacement systems. As a result, Mr. Setter has suffered injuries and damages as a result of the implant’s defective design, warning, construction and unreasonably dangerous character, the Pinnacle hip implant lawsuit states.
The Setters allege that DePuy and Johnson & Johnson are aware that Pinnacle hip implants, including the Pinnacle Acetabular Cup System, have a high failure rate that leads to pain, disability and lack of function. They further claim that Defendants are aware that Pinnacle hip implants may result in metallosis (metal blood poisoning) and biologic toxicity.
“Pinnacle devices may result in unsafe release of toxic metal ions into hip implant recipients’ tissue and bloodstream… [which] may result in metallosis, tissue death, bone erosion, and development of tumors,” the hip implant lawsuit states.
Defendants Knew About Failure Rate but Failed to Warn, Lawsuit Says
The plaintiffs say their doctors were unaware of any problems related to the DePuy Pinnacle hip implant before the hip replacement, but soon after, the plaintiff began suffering injuries and damages from the implant. In 2014, the plaintiff had to have painful hip revision surgery because of the problems and he has been told to expect future surgeries to deal with the defective hip implant.
The plaintiffs say that the makers of the DePuy Pinnacle hip implant failed to warn them and their doctors of the defective design and problems related to the product and they never would have consented to the use of the Pinnacle implant had they been warned of the problems.
The plaintiffs allege that DePuy and its parent companies were aware that the DePuy Pinnacle hip implant could cause problems in patients with the device, including, metallosis, biologic toxicity, and the unsafe release of toxic metal ions into the bloodstream. Additionally, say the plaintiffs, the device has a high failure rate leading to pain, disability, and lack of function. The device has also been associated with severe inflammation, bone erosion and the development of tumors, leading to accusations it is a defective medical device.
Studies, FDA Reports Show Problems With Pinnacle Hip Replacements
According to the hip implant lawsuit, the Food and Drug Administration has received over 1,300 adverse reports over failures of the Pinnacle Hip Implant; however, alleges the complaint, the defendants say that 99.9 percent of “Pinnacle Hip Components are in use today.”
The plaintiffs allege that the metal on metal design of the Pinnacle hip implant causes it to have a propensity to deform, leading to edge loading and loosening and increased wear. The hip implant lawsuit points to a 2006 article in the Journal of Arthroplasty reporting study findings that 90.5 percent of Pinnacle devices showed deformity which may result in negative clinical consequences. A later study reported increased level of cobalt and chromium three in patients with Pinnacle hip implants.
“All of the injuries and complications suffered by Plaintiff were caused be the defective design, warning, construction and unreasonable dangerous character of the Pinnacle Device that was implanted in him,” alleges the hip implant lawsuit. “Had Defendants not concealed the known defects, the early failure rate, the known complications and the unreasonable risks associated with the use of the Pinnacle Device, Plaintiff would not have consent to the Pinnacle Device being used in his total hip arthroplasty.”
The plaintiffs are seeking damages for their medical expenses, pain and suffering and for punitive damages against the makers of the DePuy Pinnacle Acetabular Cup System. They are also seeking costs, fees, and attorneys’ expenses.
The case is Setter v. DePuy Orthopaedics, Inc., Case No. 17-cv-00868, U.S. District Court, Western District of New York.
Do You Have a Hip Implant Lawsuit?
Drug and medical device manufacturers have a duty to ensure that their products are safe and that they comply with FDA regulations before they put the products on the market. Plaintiffs who have been injured by a medical device defect or a dangerous drug may be eligible to file a product liability or personal injury lawsuit.
Contact the attorneys at Bradley/Grombacher LLP to discuss your legal options. If you have a potential case, your defective hip implant lawyer will work tirelessly on your behalf to put together a compelling case and help you get the compensation you deserve. Fill out the form on this page now for a FREE evaluation of your potential hip implant lawsuit.