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Medtronic Infuse Bone Graft Marketing Questioned by Lawsuit, Congressional Probe

Sep 15, 2008 | Parker Waichman LLP Medtronic Inc. is facing serious questions about its marketing of the Infuse Bone Graft.  Not only does the company face a federal lawsuit alleging that it paid scores of doctors kickbacks to encourage the use of Infuse in unapproved procedures.   But Medtronic is also the subject of a Congressional investigation looking into similar charges.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body.  It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.  

In July, the Food & Drug Administration (FDA) warned that the use of  the Infuse Bone Graft had caused serious problems when it was used off-label in cervical spine (neck) surgeries.   Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

Last month,  The Wall Street Journal reported that least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of the product.  The Journal said that most these complications cases involve unwanted bone growths near nerves or in areas outside targeted fusion sites. That can lead to pain, repeat surgeries and, in some cases, emergency intervention.

While doctors are permitted to use approved medical devices in any way they see fit, it is illegal for manufactures like Medtronic to actively promote such uses.  

The Medtronic whistleblower lawsuit - filed last year in U.S. District Court in Massachusetts - was brought by two former Medtronic employees.  It names more than 110 U.S. doctors and alleges they received more than $8 million during 2006 in "sham" consulting fees — under the pretense of conducting research or education.  In reality, the suit claims,  the physicians were taking money in exchange for using and promoting Medtronic products.  

The whistleblower lawsuit alleges that the Medtronic-funded doctors were lobbying their colleagues to use Infuse in ways that weren't approved by the FDA. The doctors allegedly promoted Infuse through off-label studies, promotional efforts at professional meetings and instruction provided at a clinic in Memphis.

Senator Charles Grassley (R-Iowa) a frequent critic of the medical device industry, is also investigating Medtronic's marketing practices.  Last year, the Senator  asked Medtronic's Tennessee-based spine division to provide information about payments to 15 doctors. In a letter to Medtronic Grassley said he was concerned that  "inordinately high consulting fees, free travel and other perks distort decision-making among physicians and obscure the best interest of patients."

While a final report or hearing is expected once Grassley's investigators complete their review, Medtronic has yet to disclose all of the information the Senator requested.

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