A woman has filed a DePuy Pinnacle hip lawsuit against Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc., alleging she suffered severe adverse side effects and complications.

Plaintiff Stacy A. files the DePuy Pinnacle hip lawsuit in Texas federal court joining a growing multidistrict litigation (MDL) against the company. The lawsuit was filed on May 14, 2018.

According to the DePuy Pinnacle hip lawsuit, Stacy, a resident and citizen of the state of California, says that she underwent a left total hip arthroplasty on Oct. 2, 2009 at Valley Presbyterian Hospital. The Pinnacle device with an Ultamet liner was implanted in her left hip.

However, soon after the procedure, she says she experienced severe pain, discomfort, and inflammation.

“After surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium ions and particles to be released into … [her] blood tissue and bone surrounding the implant,” the DePuy Pinnacle hip lawsuit states.

Due to this adverse side effect and complications, Stacy claims she underwent revision surgery on July 14, 2016 in order to replace the left hip implant device. However, she also underwent a second revision total hip arthroplasty procedure on Jan. 5, 2017.

It was only recently, the DePuy Pinnacle hip lawsuit states, that she became aware of the link between the alleged defective and faulty nature of the device and the adverse side effects she suffered. According to the lawsuit, she was “unable to make an earlier discovery of the causal link despite reasonable diligence because of defendants’ failure to properly warn … [her] and her physicians about the Pinnacle Device’s defective and faulty nature …” the DePuy Pinnacle hip lawsuit states.

The DePuy Pinnacle hip lawsuit was filed on multiple counts including negligence, failure to warn, manufacturing defect, design defect, negligent misrepresentation, breach of express warranty, breach of implied warranty, and fraud.

Stacy demands a trial by jury.

Overview: DePuy Pinnacle Hip Lawsuit

A number of complaints have been linked to the Pinnacle Acetabular Cup System, manufactured to increase a patient’s range of motion and mobility. The device is a metal-on-metal (MoM) device designed and manufactured by DePuy Orthopaedics, a division of Johnson & Johnson.

The Pinnacle Acetabular Cup System was introduced to the market in 2001, but has since been linked to severe adverse side effects and complications. Some of these reported complications include the following:

• 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 device’s approval by the U.S. Food and Drug Administration (FDA) there have been almost 1,300 adverse event reports reported. The device was approved through the agency’s premarket approval process known as the 510(k) process. Through this process, thorough clinical studies affirming the product’s safety and efficacy are not required.

Critics say this faster review process has led to the extraordinary number of adverse event reports received by the FDA. Requirements for approval through the 510(k) process only includes substantial evidence that the device is “substantially equivalent” to a “grandfathered” device for approval to be granted.

Severe adverse effects and requirements for revision surgery has been blamed on how the metal acetabular liner and metal-on-metal device make contact. Through their contact, they may release metal ions such as chromium and cobalt into the patient’s soft tissues and bloodstream. This leads to a tremendous amount of other adverse side effects and complications.

The DePuy Pinnacle Hip Lawsuit is Case No. 3:18-cv-01221-K, in the U.S. District Court for the Northern District of Texas, Dallas Division.