Class Action Lawsuit Certified. Medtronic, Inc. got more bad news on the Infuse front yesterday, when a federal judge granted class action status to an investor shareholder lawsuit alleging the company illegally promoted off-label use of the controversial bone growth protein, causing stockholders financial harm.
According to a report from Newsinferno.com, Medtronic is already facing investigations by the U.S. Department of Justice, the U.S. Senate Finance Committee and the state of California regarding its marketing of the Infuse bone growth product.
In August 2009, the Minneapolis Firefighters’ Relief Association and other institutional investors alleged in an amended complaint that Medtronic had deliberately promoted the Infuse system for off-label uses and failed to disclose that its sales were largely dependent on unapproved uses.
The lawsuit sought class action status on behalf of holders of the company’s stock who purchased or acquired their shares between November 2006 and November 2008 and suffered financial losses.
U.S. District Judge Paul Magnuson of Minnesota certified the class
Yesterday, U.S. District Judge Paul Magnuson of Minnesota certified the class, rejecting Medtronic’s assertion that Plaintiffs’ counsel was inadequate and that the Plaintiffs had misrepresented witness statements. Judge Magnuson also rejected Medtronic’s opposition to the definition of the class and refused to strip the class of its lead plaintiff.
Infuse is a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery, however, it has only been approved by the U.S. Food & Drug Administration (FDA) for use in anterior-approach lumbar fusion.
The FDA issued a safety alert for rhBMP products in 2008, after their off-label use in cervical spine (neck) surgeries had been associated with serious, and sometimes life-threatening complications.