A Seattle resident claims that DePuy Orthopaedics and Johnson & Johnson failed to adequately warn consumers about the risks and severity of side effects associated with the Pinnacle hip implant.

Plaintiff Tina Marie D. alleges in the Pinnacle hip lawsuit that she sustained severe complications from the hip replacement, causing her to be permanently disabled as a direct result of DePuy and Johnson & Johnson’s alleged defective manufacturing and marketing of the Pinnacle hip implant.

Tina Marie received the Pinnacle hip replacement system in September 2008 and claims she suffered debilitating pain and metallosis, the release of toxic metal ions into her tissue and bloodstream. She will likely need to undergo premature hip revision surgery to replace the metal hip implant, according to her lawsuit.

Tina Marie alleges DePuy did not take the proper steps to test the Pinnacle hip implant before placing it on the market, or they would have discovered that it leads to metallosis and other complications. Instead, the Pinnacle hip implant was certified to be sold on the basis of DePuy’s claim that it was “substantially equivalent” to other older metal-on-metal hip implant devices without conducting clinical trials to review the hip implant’s safety.

DePuy Fails To Properly Test Pinnacle Hip Implant

The DePuy Pinnacle hip replacement system received FDA approval through the expedited 510(k) process, which only requires a manufacturer to show that its medical device is substantially similar to devices already available on the market. Manufacturers are able to bypass rigorous pretrial testing and FDA inspection.

If DePuy had been required to undergo the standard approval process, it is probable that the severe hip replacement complications stemming from metal-on-metal implants like Pinnacle would have been detected and the implants would not have been cleared for patient use.

Unless a DePuy Pinnacle recall is issued, thousands more may continue to receive this hip implant, which like the recalled ASR hip implant, was approved without the usual pre-market testing.

Pinnacle Hip Implant Lawsuits

J&J’s DePuy division faces more than 6,000 federal multidistrict-litigation lawsuits from former Pinnacle hip recipients who claim injuries that include metal poisoning in their blood. According to the hip implant lawsuits, patients say the metal-on-metal hip replacement system was defective because pieces rubbed together, causing metal to leach.

The coordinated litigation over Pinnacle metal-on-metal hip implants pending is also known as MDL No. 2244.  The DePuy Pinnacle MDL was established in May of 2011. As of June 2014, more than 6,400 individual lawsuits have been filed in the DePuy Pinnacle MDL pending before Judge Kinkeade in federal court in Dallas, Texas.

The Depuy Pinnacle Hip Implant Lawsuit is Case No. 3:13-cv-02527-K (MDL No. 2244) in the United States District Court Northern District of Texas.