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Medtronic Infuse Bone Graft Injury Lawyers

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The lawyers and attorneys at our firm are offering free consultations to individuals injured as a result of off-label use of the Medtronic Infuse Bone Graft.  Off-label use  of the Infuse Bone Graft has proven to be dangerous.  Recently, the Medtronic Infuse Bone Graft lawyers at our firm have become aware that Medtronic may have illegally promoted off-label use of Infuse.  If you or a loved one were injured after being implanted with this device in an off-label procedure, we urge you to contact one of our Medtronic Infuse Bone Graft injury lawyers as soon as possible to protect your legal rights.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body.  According to Medtronic's Website, the Infuse Bone Graft  provides a scaffolding where new bone can grow.  It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  The Food & Drug Administration (FDA) has also approved it for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation. 

The FDA has not approved this device for any other procedure.  Using it on the neck area, or operating from the back side, is considered off-label. As our Medtronic Infuse Bone Graft injury lawyers have learned, other procedures with the device put patients at significant risk of injury.  The artificial protein contained in Infuse Bone Graft  can inflame nearby tissue. If the material isn't inserted properly, or if it leaks, it can cause bone growth in areas outside the surgical site.
 

Despite the dangers, the Medtronic Infuse Bone Graft injury lawyers at our firm know that off-label use of this graft is quite common.  In fact, at least three-quarters of the roughly 200 "adverse events" reported to the FDA involve off-label uses of the product.  In November 2008, the U.S. Department of Justices began an investigation to determine if Medtronic illegally promoted off-label use of Infuse bone Graft.
 

Danger of Infuse Bone Graft Off-Label Use

In July 2008, the FDA warned the Infuse Bone Graft had caused serious problems when it was used off-label in cervical spine (neck) surgeries.   The agency said it received 38 reports over four years of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.
 

Our Medtronic Infuse Bone Graft injury lawyers are aware that this device has hurt  many more patients after it was used in other off-label situations. According to a September 2008 Wall Street Journal investigation, most these complications  involved 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.
 

Questions Surrounding Medtronic's Promotion of Infuse Bone Graft

The Medtronic Infuse Bone Graft Injury lawyers at our firm are investigating claims that the maker of this device has illegally promoted the off-label use of this product. Promoting the off-label use of a medical device is illegal, although doctors are allowed to use a device anyway they see fit.

The Infuse Bone Graft was approved in 2002, but before it was, The Wall Street Journal said the FDA had concerns about the product’s potential off-label uses.  At an advisory committee meeting discussing the product’s approval,  it asked FDA staff for recommendations on “guarding against off-label use of this product.”

According to transcripts of that meeting obtained by the Journal, Dr. Scott Boden, director of the Emory University Orthopaedics & Spine Center who helped present the committee with clinical trial data on behalf of Medtronic, told the panel that discussion about off-label use was “outside the scope of what we ought to be focusing on today.”  At the time he testified, Dr. Boden was being paid more than $100,000 a year by Medtronic, according to a lawsuit filed last year. Those payments continued at least through 2006, when he received at least $75,000, the Journal reported.

In May 2003, four other surgeons wrote a report for the Website Spine Universe that cited favorable results from using Infuse in the neck area and for fusing larger numbers of vertebrae. The authors included Atlanta surgeon Regis W. Haid Jr. and Emory University surgeon Gerald Rodts.  According to The Wall Street Journal, at least three of the four authors had financial relationships with Medtronic, but that was never mentioned in their article. 

Medtronic has also been named in three "whistleblower" lawsuits filed by former employees that alleged the company paid doctors to use Infuse Bone Graft and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, but admitted no wrongdoing.  The third lawsuit alleges that Medtronic illegally paid doctors inflated consulting fees and bogus royalty payments to promote off-label uses Infuse.
 

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.”
 

During a conference call with investors in November 2008, Medtronic's chief executive revealed that the company had received a subpoena from Justice Department regarding off-label use of Infuse Bone Graft.  Hawkins said during the call that the company is complying with the Justice Department’s request, but insisted that Medtronic was not promoting off-label use of Infuse.  Hawkins said that if doctors were using the bone graft product in off-label procedures, it was because they had determined it “was the best therapy for their patients.”
 

Legal Help for Victims of Infuse Victims of Bone Graft Injuries

If you or someone you know sustained an injury due to the off-label use of the Medtronic Infuse Bone Graft, you have valuable legal rights.  Please fill out our online form, or call 1-800 LAW INFO (1-800-529-4636) to discuss your case with one of our experienced Medtronic Infuse Bone Graft lawyers.