DePuy Orthopaedics, Inc., a Johnson & Johnson subsidiary, faces a couple’s recent Pinnacle hip implant system lawsuit, joining the growing number of lawsuits being filed against the company.

Plaintiffs Andrew and Frances C. file their Pinnacle hip implant system lawsuit due to Andrew’s serious injuries that allegedly developed as a “direct and proximate result” of being implanted with an allegedly defective DePuy pinnacle hip replacement device.

Andrew says he was implanted with the device in January 2009. He claims that as a result of the implantation he suffers and continues to suffer serious bodily injury, which includes pain and suffering.

According to the Pinnacle hip implant system lawsuit, Andrew, a resident of Pennsylvania, underwent a right-sided total hip replacement procedure at Penn State Milton S. Hershey Medical Center on Jan. 13, 2009. During the procedure, he was implanted with a DePuy Pinnacle Acetabular Cup and Pinnacle metal liner.

However, on June 19, 2017, Andrew underwent a total hip revision surgery to remove the device. This was due to the severe adverse side effects he suffered, the Pinnacle hip lawsuit states.

The Pinnacle hip implant lawsuit was filed on multiple counts including strict liability, negligence, breach of express warranty, breach of implied warranty, failure to warn, unjust enrichment, punitive damages, and loss of consortium.

The plaintiffs demand a trial by jury.

Overview: Pinnacle Hip Implant System

The Pinnacle hip implant system has been linked to a number of severe adverse effects and complications, leading thousands of patients to file lawsuits against the device’s manufacturer, DePuy Orthopaedics. The Pinnacle Acetabular Cup System, although introduced to the market in 2001 and manufactured to increase a patient’s mobility and range of motion has been linked to side effects that include:

• Hip pain
• Loosening of the Pinnacle Hip Device
• Trouble standing or walking
• Difficulty weight bearing
• Hip revision surgery
• Metal poisoning, also known as metallosis

The Pinnacle device was designed to help replace damaged and diseased hip joints, which may stem from a multitude of causes such as avascular necrosis, rheumatoid arthritis, osteoarthritis, and fracture. However, since the Pinnacle hip implant system became approved by the U.S. Food and Drug Administration (FDA), there have been more than 1,300 adverse event reports filed.

The Pinnacle System became approved through an FDA premarket review process known as the 510(k) process, which allows medical devices to enter the market far more quickly. Critics point out that this review process does not require heavy clinical studies to be conducted, which unfortunately prove and substantiate a device’s safety and effectiveness.

Through the 510(k) process, a manufacturer needs to only supply evidence that a device is “substantially equivalent” to a “grandfathered” device already approved and on the market. Andrew argues that the use of this process for the Pinnacle hip implant system is what has led to the extraordinary number of adverse event reports received by the FDA.

The Pinnacle Hip Implant System Lawsuit is Case No. 3:18-cv-01319-K, in the U.S. District Court for the Northern District of Texas, Dallas Division.