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Judge Considers Motion to Set Protocols for Preserving Biomet Explants

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On October 2, 2012, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal Biomet M2A Magnum hip lawsuits into one court in the Northern District of Indiana to form MDL No. 2391. Since then, the litigation has been involved in pre-trial proceedings under the direction of the Honorable Robert L. Miller, Jr.

In recent MDL news, Judge Miller stated he would consider a proposed order for preservation of evidence at the next status conference, scheduled for March 18, 2013. When patients go through revision surgery, the preservation of the explanted medical device, in addition to any surrounding tissue that may be removed with it, can prove to be crucial evidence in a Biomet M2A Magnum lawsuit. If the proper precautions are not taken during the surgical procedure, however, some of the evidence may be spoiled.

Biomet Hip Explants Should Be Preserved

Patients who are involved in lawsuits regarding another metal-on-metal implant, the DePuy ASR, were warned in years past to seek legal advice before going through revision surgery. Judges in medical device litigations often establish protocols for preserving the explant as evidence, as did Judge David Katz, who is presiding over the consolidated federal DePuy ASR lawsuits, in early 2011.

Judge Katz ordered that all DePuy ASR hip replacements removed from patients should be preserved and examined in a way that does no additional damage to the evidence. Specific instructions in the order directed hospitals to preserve synovial fluid and blood serum at the plaintiff’s request, and to retain the explant themselves, or to send it to a mutually agreed upon storage facility.

Judge Miller is expected to consider a similar non-destructive testing protocol at the March 18, 2013 conference, per the proposed order. He is also expected to discuss discovery deadlines and modifications to a proposed Plaintiff Fact Sheet.

Biomet M2 Magnum Associated with Higher Failure Rates

As of January 14, 2013, the Biomet MDL contained 132 pending lawsuits. Plaintiffs claim that after they were implanted with the all-metal device, they experienced pain, joint and tissue damage, and metal poisoning.

In 2011, the Australian National Joint Registry reported that patients implanted with the Biomet M2A had a yearly revision rate of 7.2 percent—much higher than typical metal-on-polyethylene hip replacement devices. That same year, the FDA ordered 21 manufacturers of metal-on-metal implants to conduct additional safety studies on their products.

Meanwhile, several scientific studies have indicated that metal-on-metal implants like the Biomet M2 Magnum have higher failure rates than other types of implants. In March 2012, for example, the Lancet published a study indicating that all metal implants, particularly those with large diameter head surfaces, failed at a higher rate than implants with a ceramic or polyethylene components.

At the February 4, 2013 Biomet MDL status conference, the parties also discussed having a "science day" to educate the Court on issues pertinent to litigation involving hip implants. Presentations are expected to occur in May, with Bellwether trials potentially scheduled in early 2014.