DePuy Pinnacle Hip Replacement Lawsuits Continue to Mount in MDL

DePuy Orthopaedics continues to face a growing number of DePuy Pinnacle hip lawsuits, as the first bellwether trials for the metal-on-metal hip replacement system are set to begin in September 2014.

According to a master case list (PDF) filed on April 1, there are currently at least 5,879 product liability lawsuits pending in the federal court system involving the DePuy metal-on-metal Pinnacle hip.

All of the cases filed in U.S. District Courts throughout the country have been consolidated as part of a federal multidistrict litigation (MDL) since May 2011, with complaints centralized before U.S. District Judge Ed Kinkeade in the Northern District of Texas for coordinated pretrial proceedings and a series of early trial dates, known as “bellwether” cases.

Although the first trial dates are only months away, new cases continue to be transferred into the DePuy Pinnacle MDL nearly three years after the litigation was centralized, with at least 450 lawsuits brought over the first three months of this year.

Metal-on-Metal Hip Litigation

The DePuy Pinnacle litigation continues to move forward, even as settlements have been reached in thousands of other metal-on-metal hip lawsuits featuring similar designs.

Over the prior decade, metal-on-metal hip replacements were introduced by a number of different manufacturers, featuring a metal femoral head that rotates within a metal acetabular cup. All of the complaints involve similar allegations that metal-on-metal hip replacements are unreasonably dangerous and defective, carrying an increased risk of failure within a few years, as the metal parts rub against each other and release microscopic metal debris into the body.

Late last year, Johnson & Johnson announced that it had agreed to pay at least $2.5 billion to settle more than 8,000 lawsuits over DePuy ASR hip replacements, which feature a metal-on-metal design that has been described as a “substantial equivalent” to the Pinnacle hip.

The DePuy Pinnacle hip system was introduced in 2001, with some variations containing a metal liner. The metal-on-metal configuration was used as the basis for the approval of the DePuy ASR hip implant in 2005, with Johnson & Johnson obtaining “fast track” 510k approval by maintaining that the DePuy ASR and DePuy Pinnacle metal-on-metal hips feature “substantially similar” designs. However, the DePuy Pinnacle was also approved under the FDA’s controversial 510k system as a substantial equivalent to older metal hips, which has allowed both designs to be implanted in thousands of people without federal regulators requiring stringent clinical trials to examine the safety of the design.

Amid reports that a higher-than-expected number of patients were experiencing problems, a DePuy ASR recall was issued in August 2010. Although some critics called for a DePuy Pinnnacle hip recall to be issued as well, the older implant was allowed to remain on the market.

More than 1,000 hip lawsuits have also been filed over the Biomet Magnum implants, which also feature a metal-on-metal design. In February 2014, a Biomet Magnum settlement agreement was reached, with the manufacturer agreeing to pay $56 million to resolve claims brought by individuals who required revision of their hip due to problems.

DePuy Pinnacle Bellwether Trials

A small group of cases in the Pinnacle MDL are being prepared for early trial dates, as DePuy has indicated it intends to defend the litigation. These bellwether test trials are designed to gauge how juries may respond to certain evidence and testimony that is likely to be offered in a number of other cases.

Following these trial dates, if a DePuy Pinnacle settlement agreement is not reached to resolve the litigation, Judge Kinkeade may begin remanding hundreds of cases to U.S. District Courts throughout the country for individual trial dates.

A status conference (PDF) is slated for April 10 to discuss preparation of the first bellwether trial, which is expected to begin in September 2014.