DePuy Orthopaedics is exposed to several thousand DePuy Pinnacle hip lawsuits, which allege defective metal hip design and early failure of the implant. The first federal bellwether trials for the metal-on-metal hip replacement system are set to begin in September 2014, in the Northern District of Texas in Dallas.
Amost 6,000 DePuy Pinnacle Lawsuits
According to the court case list, there are 5,879 defective hip product liability lawsuits pending in the federal court system involving the DePuy metal-on-metal Pinnacle hip.
Texas Federal MDL Consolidation
All of the federal cases have been consolidated as part of a federal multidistrict litigation (MDL). The lawsuits are 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.
Metal-on-Metal Hip Litigation
Over the past ten years, many similar metal-on-metal hip implants were released by different orthopedic manufacturers. These hip replacements have a metal femoral head that moves within a metal acetabular cup. The lawsuits involve allegations the that metal-on-metal hip implants are unreasonably dangerous and defective. Furthermore, the implants have an increased risk of failure within a few years, because the metal parts grind against each other and release metal debris into the body. This causes elevated cobalt and chromium blood levels, also known as metallosis.
Johnson and Johnson DePuy ASR Multi Billion Settlement
Johnson & Johnson announced a DePuy ASR hip implant settlement in November 2013. The orthopedic divison agreed to pay at least $2.5 billion to settle more than 8,000 lawsuits over DePuy ASR hip replacements. The DePuy ASR hip implant is also a metal-on-metal design that is “substantially equivalent” to the Pinnacle hip.
DePuy Pinnacle Hip System 510(k) Approval
The DePuy Pinnacle hip system was released in 2001. The metal-on-metal system was used as the basis for the approval of the DePuy ASR hip implant in 2005. Johnson & Johnson obtained FDA “fast track” 510k status by claiming that the DePuy ASR and DePuy Pinnacle metal-on-metal hips were of “substantially similar” designs.
The DePuy Pinnacle was also approved under the FDA’s 510k approval process as a substantial equivalent to older metal hips. This fast track rubber stamping approval process, has allowed hip implants to be placed in thousands of unsuspecting patients without federal oversight. As a result no meaningful clinical trials have taken place to examine the safety of the design.
Over the years, a higher-than-expected number of patients were experiencing eaarly failure problems, and a DePuy ASR recall was announced in August 2010. Some experts called for a DePuy Pinnacle hip recall as well, but the implant was allowed to remain on the market.
Metal on Metal Hip Failures
More than 1,000 hip lawsuits have been filed over the Biomet Magnum metal-on-metal implants . In February 2014, a Biomet Magnum settlement agreement was announced, the manufacturer agreed to pay $56 million to resolve claims brought by patients who required revision of their hip due to early hip failure and metallosis problems.
DePuy Pinnacle Bellwether Trials
In the Pinnacle MDL, some cases are being presented for early trial dates, known as bellwether test trials. These bellwether cases are designed to gauge how juries respond to evidence and testimony in the trials.
Following these trial dates, if a DePuy Pinnacle settlement agreement is not reached, Judge Kinkeade will remand the cases to U.S. District Courts throughout the country for individual trial dates.