A man has filed a DePuy metal on metal hip lawsuit alleging his right hip was seriously injured after the implantation.

Plaintiff Thaddeus B. said he received a DePuy Pinnacle artificial hip system in his right hip on Dec. 2, 2009. He claims he began to experience difficulty walking and severe pain in his right hip not long after the surgery. As a result of his severe discomfort and chronic pain, he says he underwent a revision surgery on Nov. 19, 2018.

Thaddeus says he never would have consented to the implantation of the Pinnacle artificial hip had DePuy “not concealed the known defects, the early failure rate, the known complications and the unreasonable risks associated with the use of the Pinnacle device.”

Dangers of DePuy Metal on Metal Hip System

According to the metal hip lawsuit, the Pinnacle hip system was approved through the FDA’s 510(k) process, a fast-track process that allows medical devices that are “substantially equivalent” to a previously approved device to gain FDA approval with virtually no clinical trials or FDA review of safety and effectiveness.

DePuy did conduct a seeding study in 2001, which was called the “Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty,” nicknamed the PIN Study.

According to research analysis of the PIN Study published in the U.S. National Library of Medicine, National Institutes of Health, DePuy and its parent company Johnson & Johnson “violated the study protocol and manipulated data; consented participants in violation of standards protecting human subjects; and did not secure Institutional Review Board approval for all study sites.”

As a result, the researchers concluded that such seeding trials are not scientific studies, but are only “malleable marketing projects” that are “disguised as science.”

The metal on metal hip system lawsuit alleges that if DePuy had conducted proper clinical trials of the Pinnacle hip device prior to releasing it to market in the early 2000s that the company would have known the system’s potential adverse effects.

In the Pinnacle hip system, a cobalt-chromium metal head rotates within a cobalt-chromium metal acetabular liner. These parts rub against each other, causing tiny particles of metal to fret away. With no other place to go, these metal fragments become buried deep in the nearby tissue where they fester.

The body tries to rid itself of these little metallic invaders by sending fluid to the area in an attempt to flush them away. As fluid collects, pseudotumors form and place pressure on the implant system and bones, causing pain. Cobalt-chromium ions also escape into the bloodstream and can induce metal poisoning.

As a result, the DePuy metal on metal hip system can cause tissue death and bone loss to the very areas it was designed to help.

In August 2018, a bellwether case resulted in a $246.1 million final judgment for six plaintiffs who alleged the Pinnacle metal hip systems were defective and that DePuy had committed fraud.

The DePuy Metal on Metal Hip Lawsuit is Case No. 3:19-cv-00429-K in the U.S. District Court of the Northern District of Texas.