Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, February 7, 2013

Biomet Failed Metal Hips: Hundreds of Lawsuits





Posted on February 6, 2013 by Cal Warriner  
An MDL (multidistrict litigation) was established for the prosecution of individual personal injury lawsuits against Biomet in the fall of 2012. The Judicial Panel on Multidistrict Litigation (JPML) heard attorney arguments on September 20, 2012, at a hearing in New York City. The plaintiffs requested consolidation of the pending lawsuits involving Biomet’s M2a Magnum metal-on-metal hip implants in federal court in New York, Texas, or California, where lawsuits had already been filed by individual plaintiffs. Biomet resisted the establishment of an MDL, but suggested that it be based in New York or New Jersey if the JPML felt that MDL coordination of the individual lawsuits was necessary. The Judicial Panel rejected all of the suggested forums and established MDL No. 2391 before Judge Robert L. Miller, Jr., United States District Court Judge in the Northern District of Indiana. Judge Miller has been a member of the Judicial Panel on Multi-District Litigation since 2003. He was appointed as a federal judge in 1985, and has served as Chief Judge in the Northern District of Indiana since 2003.
As of January 14, 2013, there were 132 individual lawsuits pending in the MDL. Given the large number of adverse event reports filed by patients who suffered harm as a result of being implanted with the defective Biomet M2a Magnum metal-on-metal hip implants, it is anticipated that hundreds of additional lawsuits will be filed by injured plaintiffs in the coming months.
Judge Miller held his most recent monthly status conference on February 4, 2013, in South Bend. The judge is currently considering a number of issues in the litigation, including guidelines on the preservation of explanted hip implants and the forms to be utilized for discovery responses. The Court granted the plaintiffs’ request for another week to prepare a Fact Sheet form that was more comprehensive than the one submitted (but less onerous than the form proposed by the Defendants), in light of the judge’s comments that he would prefer to have a more comprehensive form. The parties are also working on reaching agreements with regard to electronic discovery and predictive coding, the first steps that need to be completed in order for the large-scale production of Biomet’s documents to begin.
At the recent status conference, the court also discussed scheduling issues, including a “science day” to educate the Court on the scientific issues pertinent to the Biomet metal-on-metal hip implant litigation. Those presentations are expected to occur in May of 2013. If discovery proceeds as intended, it is likely that the Court would be in a position to begin the selection of individual cases for case-specific discovery and bellwether trial preparation as early as January of 2014. We anticipate that a number of orders will be entered this month to help streamline the litigation process. The next status conference in the Biomet MDL is scheduled for March 18, 2013.

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