A couple has filed a DePuy Pinnacle lawsuit after the husband had to undergo hip revision surgery.

Plaintiff Roger R. says he received a DePuy Pinnacle Hip Replacement System in his left hip on Jan. 26, 2009.

According to the DePuy Pinnacle lawsuit, he underwent a revision surgery due to hip implant failure and metal poisoning (metallosis) on June 1, 2018.

DePuy Orthopaedics Inc., a subsidiary of Johnson & Johnson, made the DePuy Pinnacle hip system.

Roger alleges he experiences severe and constant pain and suffering, swelling, bursitis, lack of mobility, metallosis and emotional distress. He fears he also might have to undergo additional revision surgery on his right hip implant in the future.

DePuy Pinnacle Lawsuit Allegations

The FDA has a fast-track process that allows companies to bypass the usual, more rigorous pre-market clinical trials and pre-approval processes if a new medical device is substantially equivalent to a medical device already on the market.

According to the DePuy Pinnacle lawsuit, the DePuy Pinnacle Hip Replacement System went through the fast-track process, which allowed DePuy to manufacture, market and sell the hip system “with virtually no clinical or non-clinical trials or FDA review of the hip replacement system for safety and effectiveness.”

DePuy allegedly used the FDA’s fast-track program for multiple tweaks to the hip system, which means none of the changes allegedly were observed in clinical trials.

If DePuy had conducted clinical trials of the Pinnacle hip system, the DePuy Pinnacle lawsuit alleges, “they would have discovered that the DePuy Pinnacle Hip Replacement System results in a high percentage of patients developing metallosis, tissue damage, bone erosion and pseudotumors, as well as suffering from severe and constant pain and suffering, swelling and lack of mobility.”

Clinical trials also allegedly would have helped DePuy discover that the metal-on-metal Pinnacle hip system causes the release of high levels of toxic cobalt and chromium ions into the nearby tissue and blood stream. The DePuy Pinnacle lawsuit alleges friction between the metal-on-metal acetabular cup liner and the cobalt-chromium femoral stem provide the release of toxic metal ions into the body.

The FDA purportedly has received more than 1,300 adverse event reports regarding the DePuy Pinnacle Hip Replacement System.

Because complications of the DePuy Pinnacle hip allegedly caused Roger to undergo revision surgery, he claims he has been severely and permanently injured and is at a greater risk of further injuries. According to the DePuy Pinnacle lawsuit, Roger will need more medical monitoring and treatment now than before he received the Pinnacle hip implant in 2009.

Roger further alleges that DePuy not only failed to properly test the Pinnacle hip system, but also failed to adequately warn him and other patients of the dangers of receiving the DePuy Pinnacle hip system.

The DePuy Pinnacle Lawsuit is Case No. 3:18-cv-02284-K, in the U.S. District Court for the Northern District of Texas, Dallas Division.