Depuy Pinnacle Hip Lawsuit Filed Over Need for Revision Surgery, As Thousands of Cases Move Forward

Johnson & Johnson’s DePuy Orthopaedics subsidiary continues to face new lawsuits over their metal-on-metal Pinnacle hip replacement, as more than 7,500 product liability claims brought by individuals who experienced problems with the artificial hip implant continue to move forward in the federal court system.

One of the latest cases to join the mounting litigation was brought last week by Shannon Baker, on behalf of the estate of her brother, Michael Baker.

After receiving a DePuy Pinnacle hip in 2002, Michael Baker experienced pain and complications that resulted in the need for revision surgery to remove the implant in 2012. Michael Baker died in March 2014 of causes unrelated to the hip replacement system.

The complaint (PDF) was filed in the U.S. District Court for the Northern District of Texas, where all other DePuy Pinnacle hip cases are centralized in the federal court system, as part of an MDL, or Multidistrict Litigation.

Like many other DePuy Pinnacle hip lawsuits, Baker indicates that her husband’s doctors noted an increase in his cobalt levels at the time of the revision surgery, which is a sign of metal blood poisoning that has been associated with the metal-on-metal design of the Pinnacle hip replacement system.

As of May 1, there were 7,545 similar claims centralized in the Northern District of Texas before U.S. District Judge Ed Kinkeade to reduce duplicative discovery into common issues in the cases, avoid conflicting rulings from different courts and to serve the convenience of the parties, witnesses and the courts.

The consolidated for pretrial proceedings were established in May 2011, at which time there were only about 57 cases pending throughout the entire federal court system. As a small group of cases are being prepared for bellwether trials in the MDL, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, new cases continue to be filed on behalf of people who have experienced problems with the metal-on-metal implant.

DePuy Pinnacle Hip Problems

Baker’s complaint and other similar lawsuits allege that the DePuy Pinnacle hip features an unreasonably dangerous and defective design, which was not thoroughly studied and that inadequate warnings were provided about the risk that the device may loosen and fail as microscopic metal particles are released into the body from the metal components rubbing against each other during normal daily activities.

The lawsuit claims that DePuy took a number of short cuts getting the Pinnacle hip implants on the market, in part due to the lax requirements of the 510(k) approval process, which only requires a device be substantially equivalent to devices already in use. The lawsuit claims that the company did not seek premarket approval, thus avoiding the FDA requirement to determine if a device is safe or effective.

According to the complaint, there were no Pinnacle hip clinical trials to see if it even worked, or if it was safe to use. Had they done so, the lawsuit claims, they would have discovered the risk of metallosis blood poisoning.

The FDA released new guidance for metal-on-metal hip replacements in January 2013, indicating that doctors should only use the design if other artificial hip implants are not appropriate. The agency also determined that future metal-on-metal hip designs will be required to undergo extensive human clinical trials before they will be approved.

Amid the mounting litigation, Judge Kinkeade identified ten different cases in February 2015, which are being prepared for early trial dates. Known as “bellwether” cases, the trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

While the outcomes of any bellwether trials will not be binding on other claims, they may influence any eventual DePuy Pinnacle settlements that may be reached by the manufacturer to resolve the litigation.