A woman has filed a metal-on-metal hip implant lawsuit in Texas federal court joining a growing multidistrict litigation against the product’s manufacturers, DePuy Orthopaedics.

Plaintiff Layne M. filed the metal-on-metal hip implant lawsuit on Feb. 13, 2018.

According to the metal-on-metal hip implant lawsuit, Layne, a resident of the state of Texas, was implanted with a Pinnacle Device and underwent a right total hip arthroplasty procedure on Sept. 7, 2007. She was implanted with the device to treat conditions ranging from avascular necrosis, fracture, degenerative conditions, rheumatoid arthritis, and osteoarthritis.

The Pinnacle device included a metal liner and soon after implantation the complaint alleges that she “experienced constant pain and discomfort.”

She also says that she “suffered from cobalt and chromium along with fatigue, anxiety and cognitive impairment.” Some other adverse effects also included “numbness and tingling on the left side of her body,” the metal-on-metal hip implant lawsuit states.

On March 20, 2017, she underwent revision surgery to remove the defective Pinnacle device. Layne says that she continues to suffer from hip joint pain. She says she continues to “experience harm and damage,” tingling and numbness of the left side of her face and toes, and battles anxiety and other cognitive issues.

The metal-on-metal hip implant lawsuit alleges multiple counts including negligence, failure to warn, manufacturing defect, design defect, negligent misrepresentation, breach of express warranty, and breach of implied warranty.

Layne demands a trial by jury.

Metal-on-Metal Hip Implant Facts

There are a multitude of complaints over the Pinnacle Acetabular Cup System, a metal-on-metal (MoM) manufactured by DePuy Orthopaedics, a division of Johnson & Johnson. Released in 2001 and designed to increase a patient’s range of motion and mobility, there have been several adverse side effects linked to the device when used in combination with a metal acetabular liner, Ultamet.

Side effects linked to the Pinnacle hip replacement device 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

Since the Pinnacle system was approved by the U.S. Food and Drug Administration (FDA), the agency has received nearly 1,300 adverse event reports. Many patients have experienced serious injuries and complications including the above-mentioned side effects.

Prior to being placed on the market, the device was approved through the agency’s premarket approval process known as the 510(k) process. Through this process, the FDA only requires substantial evidence that a device is “substantially equivalent” to a “grandfathered” device to gain approval.

According to the lawsuit, “Rather than being approved for use by the FDA pursuant to the rigorous premarket approval process, the Pinnacle Device metal-on-metal total hip replacement system was certified to be sold on the basis of Defendant’s claim that… it was ‘substantially equivalent’ to another older metal-on-metal hip implant device…”

The adverse side effects are said to occur as the metal acetabular liner and MoM device rub together when implanted. As they make contact, they release metal ions, such as cobalt and chromium, into the patient’s bloodstream and soft tissues.

The Metal-on-Metal Hip Implant Lawsuit is Case No. 3:18-cv-00351-K, in the U.S. District Court for the Northern District of Texas, Dallas Division.