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Litigation over Medtronic InFuse Bone Graft Product involves Allegations of Off-Label Use

Medtronic InFuse Product has Allegations of Off-Label Use

Medtronic InFuse Product has Allegations of Off-Label Use

Medtronic has become enshrouded in controversy and scandal amidst safety concerns and reports of alleged misconduct associated with its InFuse Bone Graft. InFuse uses recombinant human Bone Morphogenetic Protein (rhBMP), which helps stimulate bone growth. The U.S. Food and Drug Administration (FDA) approved InFuse in 2002, but only for very specific purposes. The product was cleared for singular placement between two vertebrae in the lumbar region. Approval later expanded to include the L4-S1 region and Anterior Lumber Interbody Fusion (ALIF). Infuse is also cleared for certain types of dental surgery.

Controversy over InFuse ensued in 2011, when The Spine Journal published an entire issue on the product. The authors reviewed 13 InFuse studies sponsored by Medtronic, and found the risk of complications was 10 to 50 times higher than reported in the studies. The review raised concerns about failure to disclose financial relationships and other ethical issues in the industry-funded research. A journal news release stated that “Study design appeared biased against common alternatives for spinal fusion, which could inflate the apparent benefit of the products. The studies included invalid claims about the risks and complications associated with using the patients’ own bone to assist fusion. In the larger trials, common and serious potential complications associated with the industry products were not reported.”

Lawsuits representing numerous individuals were recently filed over Medtronic InFuse Bone Graft and LT Cage product. The suits were 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.

Parker Waichman LLP provides free legal consultations to individuals who suffered injuries after undergoing surgical procedures using Medtronic InFuse Bone Graft. If you were implanted with InFuse and want more information about your legal rights, contact Parker Waichman today.

It is alleged that Medtronic used illegal and deceptive marketing practices to promote Infuse for off-label uses. Specifically, the suit says Medtronic misrepresented information regarding Infuse in a 2002 “Fact Sheet”; the company allegedly omitted vital safety information, including that the studies, presented as “outside objective reports,” were actually edited by the company’s own employees. Additionally, court documents indicate that Medtronic never disclosed clinical trial data showing lack of efficacy to physicians who were not paid by the company. The suit alleges that these doctors were not informed about the serious adverse events associated with off-label use of Infuse.

The lawsuit further alleges that Medtronic presented fraudulent scientific studies to external physicians and their patients and 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.

In 2012, the United States Senate Finance Committee published a report following a 16-month investigation of Medtronic InFuse stating 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. “Medtronic’s actions violate the trust patients have in their medical care. Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has,” said Senator Max Baucus, according to the release. “Patients everywhere will be better served by a more open, honest system without this kind of collusion.”

In 2008, the U.S. Food and Drug Administration (FDA) warned that off-label use of InFuse in the cervical spine is dangerous and could lead to potentially fatal complications, including “swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck.” Some patients experienced difficulty breathing, swallowing or speaking. Within 4 years of using InFuse off-label in the cervical spine, the FDA said it received at least 38 adverse event reports.

Parker Waichman LLP is involved in litigation involving the Medtronic InFuse Bone Graft. If you or someone you know would like to discuss your potential rights, contact one of our attorneys today.


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