![]() ![]() Medtronic is working to finalize settlements with about 6,000 Infuse patients in unrelated lawsuits and claims, following a December agreement to pay $12 million to five states to end their investigations into the controversial biotech product. “Even in situations where allegations are not as juicy as they are here,” Kleinberger said, the prospects for disclosing company documents can be “fraught with bad publicity” and “are sometimes enough to induce reasonable corporate decisionmakers to start thinking about settling.” Infuse is a complex product with a complicated legal history.Ĭlass certification paves the way for a discovery process in which Medtronic might have to reveal internal company records on its handling of Infuse to legal adversaries, and eventually to the public, which company executives might want to avoid. Mitchell Hamline School of Law professor emeritus Dan Kleinberger said Thursday that the order to expand the pool of potential plaintiffs could fundamentally change the legal calculus behind a potential settlement. The only plaintiffs in the suit today are the West Virginia Pipe Trades Health and Welfare Fund, the state of Hawaii’s retirement system and a German investment group called Union Asset Management Holding AG. About 6.5 million shares of Medtronic stock were traded daily during that period, and nearly 1,200 major institutions owned Medtronic stock in that time. District Chief Judge John Tunheim ruled that the West Virginia Pipe Trades class-action suit is limited to shareholders who bought stock between Sept. “If you don’t get a class certification, you’re done,” McDonnell said, “because it is not financially feasible to sue individually.” Brett McDonnell said the judge’s decision to certify class-action status in a securities-law case like this one was an important step for the plaintiffs. “We intend to pursue a vigorous defense in this matter and will continue efforts to obtain a complete dismissal of the case,” Medtronic spokesman Eric Epperson said in an e-mailed statement. Medtronic, limits the scope of the lawsuit, and the company continues to believe the litigants’ claims are without merit. ![]() On Thursday a Medtronic spokesman noted the ruling in the latest case, West Virginia Pipe Trades Health and Welfare Fund vs. The last time a federal judge in Minnesota granted class-action status to an Infuse-related shareholder lawsuit, Medtronic and the plaintiffs quickly moved into settlement talks in 2012 that resulted in Medtronic agreeing to pay $85 million to the investors to resolve that litigation. "We will continue to conduct research on rhBMP-2 to further add to an increased understanding of the benefits and risks of this important treatment option," said Rick Kuntz, senior VP and chief scientific, clinical and regulatory officer at Medtronic.A federal judge in Minnesota has granted a group of investors permission to pursue a class-action lawsuit against Medtronic over allegations that the med-tech company inflated its stock value by secretly paying doctors millions of dollars to conceal adverse events associated with its bone-growth product Infuse. The findings published in the June 18 issue of the Annals of Internal Medicine add to a growing body of evidence regarding INFUSE Bone Graft as a safe and effective treatment option for patients in approved indications for use.The findings reiterate, as with all therapies and surgical procedures, INFUSE Bone Graft poses certain risks that must be evaluated carefully by patients and physicians before use. Since it was approved, Medtronic has worked with the FDA to communicate the benefits and risks of the product in its FDA-approved labeling. Food and Drug Administration, FDA, in 2002 for use in anterior lumbar interbody spine fusion to stimulate natural bone growth. Medtronic acknowledged the publication of the findings from Yale University's third-party, independent review of INFUSE R Bone Graft, a proprietary formulation of recombinant human bone morphogenetic protein-2 ,rhBMP-2, that was approved by the U.S. ![]()
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