Lawsuit Filed over Medtronic Infuse Bone Graft ProductJun 9, 2015
A recently filed lawsuit alleges that the Medtronic InFuse Bone Graft and LT Cage product caused serious injuries, including excessive bone growth. The suit, which represents numerous individuals implanted with the device, was filed by Jerrold S. Parker of Parker Waichman LLP; Richard J. Arsenault of Neblett Beard & Arsenault; Nicholas Drakulich of The Drakulich Firm; Eric Holland of The Holland Law Firm; and Mark Lanier of The Lanier Law Firm.
Infuse was approved in 2002 for very specific uses; it was cleared for singular placement between two vertebrae in the lumbar region. In 2004, approval expanded to include the L4-S1 region. Later on, Infuse was also approved for Anterior Lumber Interbody Fusion (ALIF). The U.S. Food and Drug Administration only approved Infuse for these limited uses, meaning that Medtronic is not permitted to promote the devices for other purposes, or off-label.
According to the lawsuit, Medtronic engaged in illegal and deceptive marketing to promote Infuse for off-label uses. Allegedly, Medtronic misrepresented information regarding Infuse in a 2002 "Fact Sheet" promoting its use. The suit alleged that Medtronic hid vital safety information, including that the studies, presented as "outside objective reports," were actually edited by the company's own employees. Court documents also indicate that non-Medtronic paid physicians were never informed of clinical trial data showing the product's lack of efficacy. The suit also alleges that these doctors were not informed about serious adverse events associated with off-label use of Infuse. According to a peer-reviewed article published in The Spine Journal, adverse events associated with Infuse were 50 times higher than reported by Medtronic.
Medtronic is also accused of presenting fraudulent scientific studies to external physicians and their patients. The U.S. Senate published a report showing that the company paid roughly $210 million to company physicians who promoted the sale of Infuse off-label. Allegedly, the kickbacks were disguised as royalties.
The lawsuit alleges that Medtronic was aware of dangers associated with off-label use of Infuse, but continued to promote the product for unapproved uses with great success; 85 to 90 percent of Infuse sales stem from off-label uses.