Medtronic Infuse Lawsuit
Medtronic Infuse Lawsuit | Lawyers, Lawsuits | Side Effects: Acute Severe Swelling, Severe Neck Swelling, Inflammed Tissue Difficulty Swallowing, Difficulty Breathing, Difficulty Speaking, Speech Impaired, Uncontrolled Bone Growth, Ectopic Bone Growth, Nerve Injuries, Severe Pain, Chronic Pain, Chronic Radiating Pain, Chronic Radiating Leg Pain, Chronic Radiating Arm Pain, Neuritis, Radiculopathy, Radiculitis, Male Sterility, Retrograde Ejaculation, Uro-Genital Injuries Swelling, Cauda Equina Syndrome
Medtronic Infuse Lawsuit : Off-Label Use
- Medtronic Infuse Bone Graft Physician Labeling
- Medtronic Infuse Bone Graft Application Data
- Medtronic Infuse Bone Graft PMA Letter from Department of Health & Human Services
Off-label use of the Medtronic Infuse Bone Graft has proven to be dangerous and the defective medical device attorneys at the personal injury law firm of Parker Waichman LLP are offering free lawsuit evaluations to individuals injured as a result of the off-label use of the device. 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 at 1-800-LAW-INFO(1-800-529-4636).
The Medtronic 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 U.S. 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.
Parker Waichman LLP has learned that Congress is investigating the possible payment to Orthopaedic Surgeons to hide serious side effects of the Medtronic Infuse Bone Graft. In addition, a recentlt released report stated that during clinial trials, Medtronic was aware of problems with the Infuse Bone Graft device
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 Justice 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 Parker Waichman LLP 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
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
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 of the Infuse product.
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, Senator 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, William A. Hawkins 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. Parker Waichman LLP urges you to 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.
June 28, 2011: Medtronic Clinical Trials showed Infuse Bone Graft Issues