A hip replacement patient recently filed a new lawsuit against DePuy, alleging that their Pinnacle hip replacement system caused serious health complications.

Plaintiff Charleen C. recently filed a lawsuit against DePuy Orthopaedics Inc., Johnson & Johnson Inc., and others, alleging that their Pinnacle hip replacement system caused metal poisoning, severe inflammation, and implant failure.

In January 2010, Charleen says she had a right hip replacement surgery and was implanted with the Pinnacle hip replacement system. A year later, in January 2011, she had her left hip replaced with the same Pinnacle hip replacement system.

However, she says she began experiencing inflammation, pain, and discomfort due to alleged metal debris released into her bone and tissue by the implant. In December 2016, she had her left hip implant explanted and replaced, according to her hip implant lawsuit.

The Pinnacle hip replacement system was released in 2001 as a hip replacement implant for joints damaged or diseased due to fracture, osteoarthritis, rheumatoid arthritis, and avascular necrosis. DePuy allegedly marketed the Pinnacle hip replacement system as “[u]niquely designed to meet the demands of active patients like you –and help reduce pain”.

The Pinnacle hip replacement system was also allegedly marketed as using “TrueGlide” technology, allowing the body to form a thin film of lubrication between surfaces, enabling “a more fluid range of natural motion”.

However, Charleen argues that the metal-on-metal design of the Pinnacle hip replacement system can lead to metallosis, toxic metals in the blood stream, tissue death, bone erosion, and development of tumors. This can allegedly cause inflammation, pain, and poor range of motion. Charleen claims that the wear between the metal components of the implant can generate metal debris in the joint, leading the complications and increasing the chance of implant failure.

The lawsuit argues that DePuy utilized a fast-track approval process to avoid clinical testing. The U.S. Food and Drug Administration (FDA) allows certain devices to be approved via the 510(k) process. In this process, the new device has to be proven sufficiently similar to a device that has already been approved. This streamlines the process for approval, but also creates the risk of releasing under-tested devices into the market.

The lawsuit claims that DePuy should have warned consumers of the risks associated with the Pinnacle hip replacement system.

“Defendants knew or should have known that the [Pinnacle hip replacement system] could fail early in patients therefore give rise to physical injury, pain and suffering, debilitation, and the need for a revision surgery to replace the device with the attendant risks of complications and death from such further surgery, but failed to give consumers adequate warning of such risks,” the lawsuit states.

Charleen accuses the defendants of negligence, strict products liability for manufacturing defect, strict products liability for design defect, strict products liability for inadequate warning, breach of warranties, negligent misrepresentation, and fraud. The lawsuit seeks compensation for medical expenses, loss of earnings, disfigurement, pain and suffering, mental anguish, and emotional distress. Charleen also seeks punitive damages, court costs, and attorneys’ fees.

The Pinnacle DePuy Lawsuit is Case No. 3:18-cv-01177-K in the United States District Court for the Northern District of Texas.