Trial Dates in Litigation Over Recalled DePuy Hips Scheduled to Begin
Thousands of individuals throughout the United States have filed product liability lawsuits after experiencing problems with the recalled DePuy ASR hip replacement system, and the first trial date has now been scheduled to start at the end of this year.
According to a scheduling order issued by Nevada Judge Linda Bell, trial is expected to begin on December 3, 2012 in cases brought by three women in state court, who all had to undergo revision surgery due to complications and failures with their DePuy hip implants.
Additional trial dates are expected to begin in January 2012 in Maryland state court and March or April 2013 in the federal court system, according to a recent report by Bloomberg News.
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More than 6,000 people have filed a Depuy ASR hip recall lawsuit, alleging that the manufacturer knew or should have known that the implant was defective long before it was removed from the market in August 2010.
Approximately 4,200 of the complaints have been filed in various federal district courts, which are all consolidated before U.S. District Judge David Katz for pretrial proceedings, as part of an MDL or multidistrict litigation.
Lawyers for both sides met with Judge Katz earlier this week to discuss the process for selecting the first trial dates in the federal litigation, known as “bellwether” cases, because they are used to help gauge how juries are likely to respond to evidence and testimony that will be repeated throughout the litigation.
More than 93,000 DePuy ASR hip implants were sold worldwide before the recall, including about 40,000 in the United States. At the time they were removed from the market, DePuy Orthopaedics, a subsidiary of Johnson & Johnson, indicated that about one out of every eight implants were failing within five years after surgery.
The DePuy ASR is a metal-on-metal hip replacement system, which features chromium and cobalt in it’s ball-and-socket design. As the metal parts rub against each other, microscopic metal particles may be shed into the body, potentially causing metallosis, which may cause the device to loosen or fail.
Similar product liability lawsuits have also been filed over other metal-on-metal hip replacement systems, including the DePuy Pinnacle hip, Biomet M2A-Magnum hip, Wright Conserve hip and other all-metal designs.
In May 2011, the FDA asked device manufacturers to obtain more information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal they actually shed and what the potential side effects of metallosis are.
On February 28, Britain’s health agency, the Medicines and Healthcare Products Regulatory Agency (MHRA) issued new guidance stating that patients who have received large-head metal hip implants should have blood tests to check for metallosis every year for the rest of their lives.
This coming June, an independent FDA advisory panel will look at the safety of all metal-on-metal hip replacement systems.
The committee is charged with discussing failure rates, testing for metal ion blood poisoning (known as metallosis), imaging methods, local and systemic complications, patient risk factors and considerations for follow-up after surgery. The committee will then make recommendations to the FDA on how to proceed. The agency notes that it is considering whether to make metal-on-metal hip systems “subject to more rigorous testing and premarket review requirements.”
While the recommendations of the committee are not binding on the FDA, they usually factor significantly in the any final decisions made by the agency.
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