A recently filed lawsuit against DePuy Orthopaedics and parent company Johnson & Johnson alleges the manufacturers negligently designed, manufactured and marketed the DePuy Pinnacle hip replacement.

Plaintiff Gwendolyn S.filed her DePuy Pinnacle hip replacement lawsuit in Texas federal court as part of the multidistrict litigation currently pending against the hip implant manufacturers.

The Pinnacle hip implant was marketed as having advantages over other hip implants and catered to younger patients wishing to live an active lifestyle, states the DePuy Pinnacle hip replacement lawsuit. It was designed to mimic the body’s natural ball-and-socket hip joint in order to increase stability and range of motion while decreasing the pain associated with hip problems.

The Pinnacle Device itself consists of four components: 1) a metal femoral stem that becomes inserted inside the femur bone 2) the metal femoral head, also known as the ball, that connects to the top of the stem 3) a metal acetabulum shell, or socket and 4) a liner that attaches to the inside portion of the socket.

In the DePuy Pinnacle hip, the liner is made of chromium-cobalt. The femoral head rotates within the metal liner of the device, making it a metal-on-metal hip implant due to the metal pieces touching. Other hip implants have liners comprised of polyethylene or ceramic, so while they may have metal components, they are not considered to be metal-on-metal like the DePuy Pinnacle hip replacement.

It is this very metal-on-metal design that has allegedly caused problems for DePuy Pinnacle hip patients and patients who have other metal-on-metal hip implants from other manufacturers.

The DePuy Pinnacle hip replacement lawsuit states that the device was approved under the FDA’s 510(k) approval process where it was claimed by the manufacturer to be “substantially equivalent” to another hip implant device that the manufacturers had previously sold.

The lawsuit argues, however, that since there was inadequate clinical testing prior to the market release, problems involving the device were not previously uncovered, leading a number of patients to have problems.

The main problems reported by Pinnacle device users who go on to file lawsuits are metallosis, biologic toxicity, implant loosening and device failure leading to revision surgery. The friction created by the metal-on-metal interaction of the device causes metal flake off and enter the patient’s body and blood stream, causing localized and systemic issues for patients who have the implant.

In Gwendolyn’s case, she had the Pinnacle device implanted in February 2008 but then suffered from significant pain and discomfort, stiffness, loss of motion, metallosis, implant loosening, necrosis, soft tissue damage, muscle damage and other injuries that led to her needing a revision surgery that was performed in 2013.

Unfortunately, later that year, Gwendolyn had to undergo a second revision surgery and then three weeks later underwent an open irrigation and debridement surgery under general anesthesia following the second procedure.

“As a direct and proximate cause of the defect implanted into Plaintiff, and the Defendants’ wrongful conduct, Plaintiff has undergone and will continue to undergo medical treatment, and sustained and continues to suffered economic damages (including medical expenses), injury, pain, suffering and emotional distress,” the Pinnacle hip replacement lawsuit states.

Gwendolyn has raised a number of allegations against the defendants including negligence, strict products liability for design defect and failure to warn, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud, unjust enrichment and punitive damages.

Plaintiff is seeking compensation for economic and noneconomic losses, punitive/exemplary damages, attorneys’ fees and costs, pre-and post-judgment interest and any additional relief deemed just and proper by the court. She is seeking a trial by jury.

The DePuy Pinnacle Replacement Lawsuit is Case No. 3:17-cv-01998-K and is part of the DePuy MDL In Re: DePuy Orthopedics, Inc., Pinnacle Hip Implant Products Liability Litigation, MDL No. 2244 in the U.S. District Court for the District of Texas, Dallas Division.