An Arizona woman has added her claim to the multidistrict products liability litigation, alleging complications related to the DePuy Pinnacle hip replacement system. Plaintiff Jatasha J. is suing DePuy Orthopaedics, its parent company Johnson & Johnson, and their related companies, all of whom participate in the manufacturing or distribution of the DePuy Pinnacle Acetabular Cup System.

In September 2008, Jatasha underwent replacement of her right hip joint, receiving a Pinnacle implant system with a metal liner. After the surgery, she suffered from pain, swelling, and difficulty sleeping. In October 2014, she underwent hip revision surgery to have the Pinnacle implant removed. She now alleges that the hip implant complications she experienced resulted from the Pinnacle system’s design defect.

Depuy Bypasses Required Hip Implant Clinical Trials

Jatasha’s DePuy hip lawsuit alleges the defendants told the FDA that the Pinnacle system was “substantially equivalent” to a pre-MDA device. She claims DePuy did this in order to avoid the more rigorous pre-market approval process that would have required clinical trials to evaluate the medical device’s safety.

The FDA approved the DePuy Pinnacle system under the abbreviated procedures used for new medical devices that are “substantially equivalent” to older devices approved prior to the effective date of the Medical Device Amendments to the Food, Drug and Cosmetics Act of 1938. These abbreviated procedures do not require clinical trials to evaluate the device’s safety.

The FDA does not make a particular determination as to whether a new device is “substantially equivalent” to a pre-MDA device.

Depuy’s Pinnacle Hip Implant Complications

Jatasha says the Pinnacle hip implant’s history has been riddled with reports of hip implant complications. She says the defendants have received over 1,300 reports of hip implant complications since 2002. She cites a three-month period in the beginning of 2011, at which time the FDA received over 250 Adverse Event Reports specific to the Pinnacle system.

Patients reported symptoms as serious as disarticulation, catastrophic failure, necrotic tissue forming in and around the joint, and metallosis (heavy metal poisoning) severe enough to require surgical removal of the hip implant.

Jatasha alleges that had the Pinnacle hip implant been required undergo clinical trials to get FDA approval, these hip implant problems would have been discovered without leaving it to hundreds of Pinnacle patients to discover them the hard way.

She also cites action taken by several other governmental authorities as evidence of the Pinnacle system’s defects. Britain’s Medicines and Healthcare Products Regulatory Agency implemented requirements that physicians monitor hip implant recipients’ levels of cobalt and chromium in their blood and watch for evidence of soft tissue reactions.

The Alaska Department of Health also issued a warning about the metal-on-metal hip implant’s tendency to cause metallosis, or elevated metal toxicity.

This hip implant lawsuit raises claims for defective product design and manufacture, failure to warn, negligence, negligence per se (claiming that defendants’ actions constitute negligence based on their alleged violation of the Food, Drug and Cosmetics Act), negligent misrepresentation, fraudulent concealment, breach of warranty, and deceptive trade practices.

Jatasha also argues the statute of limitations should not bar her hip implant lawsuit. because the defendants’ alleged fraudulent concealment of information about the Pinnacle system prevented her from discovering the device’s allegedly defective nature.

The Depuy Pinnacle Hip Implant Lawsuit is In re: DePuy Orthopaedics Inc. Pinnacle Device Implant Products Liability Litigation, Case No. 3:11-MD-2244-K, in the U.S. District Court for the Northern District of Texas.