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The U.S. District Judge presiding over all DePuy Pinnacle hip lawsuits pending throughout the federal court system has granted a request to stay most of the litigation, other than a small group of bellwether cases that are scheduled to go to trial beginning in September 2014.
There are currently more than 5,000 product liability lawsuits over the DePuy Pinnacle metal-on-metal hip replacement pending in the federal court system, which have been centralized for pretrial proceedings before U.S. District Judge Ed Kinkeade in the Northern District of Texas, as part of an MDL, or Multidistrict Litigation.
All of the complaints involve similar allegations that hip replacement patients experienced problems with a DePuy Pinnacle metal-on-metal implant within a few years after receiving the artificial hip, which is designed to last 15 to 20 years.
As part of the coordinated management of the DePuy Pinnacle litigation, a small group of cases are being prepared for early trial dates, known as “bellwether” cases. The preparation of these cases and the outcomes of any trials are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout a large number of cases.
In an Order (PDF) issued September 30, Judge Kinkeade granted a request filed by the parties to stay all cases pending in the DePuy Pinnacle MDL, other than those selected for bellwether trials. The stay is expected to remain in place until after the completion of the bellwether trials, which are currently expected to begin in September 2014.
Following the DePuy Pinnacle bellwether trials, if an agreement to settle the lawsuits or another resolution is not reached, Judge Kinkeade could begin remanding thousands of individual cases back to U.S. District Courts throughout the country for individual trials.
DePuy Hip Replacement Problems
The litigation centralized before Judge Kinkeade involves the metal-on-metal design for the DePuy Pinnacle hip replacement, which features a metal femoral head that sits directly in contact with a metal acetabular cup. According to allegations raised in the complaints, the metal-on-metal design is defective and prone to release microscopic particles as the metal parts rub against each other, increasing the risk of loosening and failure of the artificial hip within a few years.
The complaints are similar to lawsuits over DePuy ASR hip replacements, which were recalled in August 2010 amid reports of a higher-than-acceptable failure rate.
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.
Johnson & Johnson’s DePuy Orthopaedic’s subsidiary also faces nearly 12,000 product liability lawsuits involving ASR implants that failed. The first bellwether trials in that litigation are just now beginning, but indications suggest that Johnson & Johnson is considering offers to settle the DePuy ASR lawsuits rather than facing jury trials.
At least two cases have already gone to trial in state court, including a California lawsuit that resulted in a jury award of $8.3 million in damages for one man who received a DePuy ASR hip. However, a second trial held in Illinois state court resulted in a defense verdict for the manufacturer.
Earlier this month it was reported that DePuy settled a case set for trial in California state court, and reports have suggested that Johnson & Johnson is preparing to offer more than $3 billion to resolve DePuy ASR lawsuits, which would average out to about $300,000 per case.
In the federal DePuy ASR MDL, which has been centralized before U>S. District Judge David A. Katz in the Northern District of Ohio, the first bellwether trials are expected to begin by early next year. A case was originally scheduled for early September, but it was delayed days before trial was set to begin.
In addition to lawsuits over DePuy hip replacements, other manufacturers of metal-on-metal implants face similar allegations that they failed to adequately research the design or warn about the risk of problems. Additional MDLs have been established in the federal court system for Biomet M2A Magnum metal hip lawsuits and Wright Medical Conserve Cup metal hip lawsuits.
In January 2013, the FDA released new guidance for metal-on-metal hip replacements, 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.