A Florida resident claims that she suffered substantial injuries and damage as a result of DePuy Orthopaedics (DePuy) and Johnson & Johnson’s failure to adequately warn consumers about the risks and severity of side effects from the DePuy Pinnacle hip implant.

Plaintiff Linda K. has filed a DePuy hip lawsuit against the manufacturers, claiming she sustained serious hip implant complications, causing her to develop metallosis and severe pain as a direct result of DePuy and Johnson & Johnson’s defective manufacturing and marketing of the Pinnacle hip replacement system.

In March 2007, Linda underwent a right total hip replacement at which time she received the Pinnacle Hip Implant metal insert, according to the DePuy hip lawsuit. Shortly after, she allegedly began suffering debilitating pain as well as metallosis, the release of toxic metal ions into her tissue and bloodstream. Due to her chronic pain and discomfort and other symptoms, Linda was required to undergo premature hip revision surgery to remove the Pinnacle hip implant.

Linda alleges in the DePuy hip lawsuit that the manufacturers took no steps to test the Pinnacle hip replacement system before releasing it on the market, otherwise they would have discovered that it leads to metallosis and other hip replacement 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, conducting no clinical trials to review the hip implant’s safety.

Pinnacle Hip Implant Receives Fast-Track FDA Approval

The DePuy Pinnacle hip replacement system received fast-track FDA approval through the 510(k) process. This process 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 the metal-on-metal hip implants would have been detected and the implants would not have been cleared for patient use.

Depuy Hip Implant Lawsuits

J&J’s DePuy division faces more than 6,000 federal multidistrict litigation (MDL) lawsuits from former Pinnacle hip recipients who claim injuries that include metal poisoning in their blood. According to the Pinnacle hip 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 was established in May of 2011. As of June 2014, more than 6,400 individual lawsuits have been filed in the national multidistrict litigation proceedings that are pending before Judge Kinkeade in federal court in Dallas, Texas.

The DePuy Hip Implant Lawsuit filed by Linda K. is Case No. 3:15-cv-02248-K (MDL No. 2244) in the United States District Court Northern District of Texas, Dallas Division.