Another hip replacement patient has sued DePuy, alleging the company willfully ignored and concealed information about the problems with its Pinnacle implant.

Plaintiff Harriet H. of North Carolina underwent right-side hip replacement surgery in December 2007. The artificial hip she received was a Pinnacle Acetabular cup and device replacement system, manufactured by defendant DePuy Orthopaedics.

After the Pinnacle hip replacement surgery, Harriet began to have pain and instability in her new hip. Blood tests showed she had higher than normal levels of cobalt and chromium in her blood. Harriet says she continues to need ongoing medical treatment related to her Pinnacle implant.

Background on Pinnacle Hip Implant

The Pinnacle system is designed to be a physical replacement for the patient’s original, natural hip joint. The Pinnacle consists of a metal stem that attaches to the femur, a ball-shaped femoral head, a titanium acetabular cup, and a cobalt and chromium liner between the head and the cup. The liner, it appears, forces load-bearing metal surfaces to rub against each other. Harriet says that this metal-on-metal hip implant sheds toxic amounts of cobalt and chromium into the body. That action in turn causes pain, looseness, and dislocation; it can lead to accumulation of excess fluid inside the joint and can cause bone and soft tissue to die.

Harriet alleges that in the course of bringing the Pinnacle system to market, DePuy took advantage of a shortcut in the FDA approval process to avoid conducting proper clinical trials. Under the Medical Device Amendments to the Food, Drug and Cosmetics Act of 1938, devices like the Pinnacle are allowed to skip the premarket approval process if they are “substantially similar” to some device that had been on the market before the amendments were passed.

While a manufacturer submitting a device for approval can assert the device is substantially similar to an older, grandfathered device, the amendments do not actually require the FDA to make a formal determination on that issue. DePuy was able to get FDA approval of the Pinnacle system by means of this abbreviated process and so managed to avoid conducting rigorous clinical trials of the device.

Pinnacle Hip Lawsuit Allegations

From as early as 2002 through the present, DePuy received 1,300 reports of Pinnacle device failures, Harriet claims. Based on those reports, Harriet says the company was clearly on notice that the Pinnacle system was defective.

According to Harriet’s hip implant lawsuit, the Pinnacle device was a successful moneymaker for DePuy and its parent company Johnson & Johnson. The system yielded over $5.4 billion in sales in 2009 alone. Harriet alleges that to protect the healthy revenue stream from Pinnacle sales, DePuy intentionally did not address the reports of failures, either by recalling the product or by promulgating safety information.

Harriet’s hip implant lawsuit names as defendants DePuy Orthopaedics, its parent company Johnson & Johnson, and their related companies. She is raising claims for negligence, strict products liability for a manufacturing defect, strict products liability for a design defect, failure to warn, infliction of emotional distress (both negligent and intentional), breach of warranty (both express and implied), fraud, and violation of Texas state consumer protection law. She is also seeking an award of punitive damages based on the defendants’ allegedly knowing concealment of important information about problems with the Pinnacle system and their allegedly purposeful misrepresentation of the safety and efficacy of the device.

Harriet’s DePuy Hip Lawsuit is part of the Pinnacle Hip Multidistrict Litigation, MDL No. 3:11-MD-2244-K, in the U.S. District Court for the Northern District of Texas.