Lawsuit Filed Over Medtronic’s Use of InFuse Bone Growth Device for Off-Label Purposes

A lawsuit has been filed against medical device maker Medtronic on behalf of numerous patients who allege the company’s InFuse bone graft product caused injuries including catastrophic, unchecked bone growth in the spinal column.

Court documents allege product liability and fraud against Medtronic Inc. and its subsidiaries, Medtronic Sofamor Danek, USA, Inc., and Medtronic SofamorDanek, Inc., over its InFuse Bone Graft LT-Cage Lumbar Tapered Fusion Device System. InFuse is only approved by the U.S. Food and Drug Administration (FDA) for use in a single level fusion. The bone growth device was approved for singular placement between two vertebrae in the lumbar region in 2002. In 2004, federal health regulators approved InFuse for use in the L4-S1 region, specifically for a surgical approach known as the Anterior Lumber Interbody Fusion (ALIF).

The FDA’s limited approval of InFuse was intended to also limit Medtronic’s marketing and sales of the device, according to court documents. Rather than go through the traditional Pre-Market Approval (PMA) channels to gain expanded approval from the agency, however, Medtronic allegedly did so through the use of an illegal, false and deceptive marketing scheme to promote off-label uses of InFuse.

As part of its marketing for InFuse, Medtronic released a “Fact Sheet” in 2002 promoting the results of company-sponsored scientific studies. The lawsuit alleges Medtronic deliberately concealed critical safety information in the “Fact Sheet” and studies. The medical device maker claimed that the studies were “outside objective reports,” but were, in fact, written or re-written by Medtronic’s own highly paid agents. Court documents also allege the company was actively involved in the writing and editing of the articles, as well as decisions to include and exclude vital health and safety information.

As early as 2006, doctors reported adverse events associated with the unapproved use of Infuse in the cervical spine including swelling, dysphagia (difficulty swallowing) and dysphonia (voice disorders), court documents show. The authors of a peer-reviewed article published in The Spine Journal, the safety information Medtronic allegedly concealed – including adverse events and serious increased risks – may actually be 50 times more than the company reported.

The lawsuit alleges that Medtronic’s false and deceptive marketing scheme proved so effective that 85 to 90 percent of the InFuse sales were derived from off-label uses. According to lawsuit documentation, an off-label use rate this high cannot occur without major off-label promotion, and the scheme raked in billions of dollars for Medtronic.

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