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Federal Judge Orders Medtronic To Produce Safety Data on Infuse

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Minnesota federal Judge Paul Magnuson has ordered Medtronic to produce sales and marketing materials dealing with the safety profile of Infuse bone growth protein generated between Jan 1, 2005 to December 31, 2009 in a lawsuit filed by be Medtronic shareholders.

The lawsuit was filed in the U.S. District Court for Minnesota and alleges that  “Medtronic and its stable of highly paid doctor-consultants recklessly downplayed the safety risks of Infuse – especially in off-label procedures – and that Medtronic’s improper off-label marketing and revenue growth were directly tied to a troubling and financially dangerous rise in safety concerns linked to Infuse, including ‘potentially serious, and even deadly, adverse events, particularly in the cervical spine.'”

The lawsuit accuses Medtronic and former CEO’s Bill Hawkins and Arthur Collins Jr., as well as CFO Gary Ellis of making “materially false and misleading statements and omissions concerning the sale, promotion, and marketing” of Infuse. “In particular, plaintiffs allege that defendants failed to disclose that the strong revenue generated from sales of Infuse was the result of marketing for off-label use, and that when the market learned of this fact, the stock price fell,” said Judge Paul Magnuson.

When asking for the documentation, the plaintiffs referred to a Spine Journal expose to request documentation from 2002 to the present. “The court does not find compelling circumstances in the instant case. While the Spine Journal article itself may be new evidence, since plaintiffs already moved for and were granted a motion to compel production of documents on this issue from some of the doctors whose publications were criticized by the Spine Journal article, its recent publication does not alter the landscape of what plaintiffs knew at the time of the earlier order,” the judge wrote. “As a result, the court does not find the circumstances dictate alteration of the relevant discovery time period and declines to so extend as advocated for by plaintiffs.” disclaimer: This article: Federal Judge Orders Medtronic To Produce Safety Data on Infuse was posted on Tuesday, October 18th, 2011 at 7:52 pm at and is filed under Medical Device Lawsuits.

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