Texas Resident Files Lawsuit Alleging DePuy Hip Replacement Caused Him Permanent Disability
Medical device manufacturers Johnson & Johnson and DePuy are facing an additional lawsuit regarding their DePuy Pinnacle hip replacement device. The lawsuit was filed by Stephen Dembrowski in the Northern District of Texas, and alleges that his hip replacement caused him pain serious injuries resulting in possibly permanent disability. Dembrowski joins many other plaintiffs suing DePuy for complications from DePuy hip implant malfunctions.
According to Dembrowski’s Pinnacle hip lawsuit, he had surgery to implant his device on May 26, 2009. He began to suffer from symptoms including severe pain in his hip joint and causing him disability, eventually resulting in medical expenses, lost wages and costly rehabilitation. He is suing Johnson & Johnson and DePuy for damages of the punitive, compensatory and exemplary nature.
Pinnacle hip lawsuit questions device approval process
Dembrowski’s lawsuit cites a common complaint against DePuy hip implants relating to the process by which it attained regulatory approval. The Pinnacle model underwent the 510(k) clearance process, which allows certain devices to eschew the normal battery of testing required for new device approval if they are able to demonstrate enough of a similarity between their device and an existing, already approved device. However, critics of the Pinnacle hip’s approval claim that it is insufficient to guarantee the safety of a new device, and that clinical testing should be required.
DePuy hip recall already issued for a previous model
DePuy hip devices have already faced public scrutiny. A previous DePuy model, the ASR, was recalled in 2010 due to an unusually high rate of metallosis after DePuy hip replacement in certain patients. The DePuy hip device used a metal-on-metal design, in which various components (all made of metal) rubbed up against one another during the normal course of movement for the device. The friction causes small pieces of metal to break off from the device and enter the blood stream, causing metal poisoning. The Pinnacle model is available in a similar metal on metal design, and hip replacement patients and medical professionals worry that the risk of metal poisoning remains.