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Medtronic Reaches $85 Million Settlement with Shareholders Over Infuse

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Medical device maker, Medtronic, has agreed to settle an Infuse shareholder lawsuit for $85 million. The action settles a federal securities class action lawsuit.
The lawsuit, said The Star Tribune, alleged that Medtronic misled investors about its Infuse product, a bone-growth device. Medtronic denied, in a statement, “that it made any misrepresentations or omissions or that it otherwise engaged in any wrongdoing,” according to the Star Tribune, which noted that Medtronic officials were not made available for comment.

Infuse was approved in 2002 as a bone graft product made from genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2) that stimulates bone growth. The U.S. Food & Drug Administration (FDA) cleared Infuse for use in only one type of spine surgery called anterior approach lumbar fusion, and two types of dental surgeries. In July 2008, the agency issued a warning that Infuse, and similar bone growth products, caused serious and, sometimes, life-threatening complications when used in off-label in spinal procedures.

The class action, filed in federal court in December 2008 against Infuse and some of its officers, alleges that between November 2006 and November 2008, Medtronic misled its investors profit expectations of its Infuse device, said the Star Tribune. The lawsuit claims that Infuse sales were more dependent on off-label uses than was disclosed by Medtronic, and this omission increased Medtronic’s stock price.

The lawsuit was filed by the Minneapolis Firefighters Relief Association, according to Medtronic, said the Star Tribune; Oklahoma Teachers’ Retirement System, the Oklahoma Firefighters Pension Fund, and the Westmoreland County Employee Retirement System are the other plaintiffs in the case.

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The proposed settlement is subject to final documentation being completed and court approval and is expected to be recorded as a one-time charge in Medtronic’s fourth fiscal quarter ending April 27.

This past December, Medtronic settled a U.S. Department of Justice lawsuit over off-label marketing for $23.5 million without admitting wrongdoing. Also, the U.S. Senate Finance Committee and the California attorney general are conducting a probe Infuse marketing and, this summer The Spine Journal raised serious questions about the validity of research used to gain FDA approval of the bone growth product.

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