The Medtronic Infuse Bone Graft, manufactured by Medtronic, Inc., was approved by the Food and Drug Administration (“FDA”) to promote bone growth during lower-back (lumbar) spinal repair surgery. But on July 1, 2008, the FDA issued a Public Health Notification about potentially fatal complications arising from non-approved uses of the product in spinal surgeries of the neck. When Medtronic Bone InFuse and similar products are used in cervical (spinal) neck fusion, the patient may suffer difficulty in speaking, breathing, and swallowing; swelling of the neck and throat tissue; and death. The FDA has received at least 38 reports of patients who suffered severe complications when Medtronic InFuse Bone Graft was used in off-label cervical spine (neck) surgeries.
Medtronic Bone InFuse Lawsuits
At least one Medtronic Bone InFuse lawsuit has been filed, alleging that the InFuse Bone Graft was used illegally, resulting in the death of a patient. Following the FDA Public Health Notification, the Department of Justice began investigating Medtronic’s possible illegal off-label marketing of the InFuse Bone Graft for spinal surgeries of the neck. Spinal fusion surgery patients who experienced allergy-like reactions, including swelling of the neck and throat tissue, within two weeks of surgery may be suffering from adverse reactions to Medtronic Bone InFuse or a similar product. Contacting a lawyer and obtaining the surgical report will allow an attorney to identify whether the InFuse Bone Graft has been improperly used during surgery.
Medtronic Bone InFuse Falsified Reports
On May 12, 2009, the New York Times reported that Dr. Timothy Kuklo, a paid Medtronic consultant, falsified reports about the success of Medtronic Bone InFuse used to repair the shattered bones of wounded soldiers. Additionally, the Army discovered that Kuklo forged the names of the four doctors that he claimed were his co-authors on the Medtronic Bone InFuse reports. Kuklo had not received Army approval to be hired as a Medtronic consultant, and the company did not disclose its relationship with Kuklo in its official list of paid consultants. In a letter sent to Medtronic and entered into the Congressional record on May 20, 2009, Senator Charles E. Grassley of Iowa rebuked the company for omitting Kuklo’s name from its consultants list. Senator Grassley has been investigating Medtronic for over a year, specifically regarding whether the company illegally advertised uses of Medtronic Bone InFuse for off-label uses not approved by the FDA.
Medtronic Bone Infuse Lawyer
If you or a loved one has been injured by Medtronic Bone Infuse, or suffered complications after undergoing spinal graft surgery of the neck, contact a Medtronic Bone Infuse lawyer today. You may be entitled to compensation for your lost wages, pain and suffering, and medical expenses. Contact a Medtronic Bone Infuse lawyer at Bernstein Liebhard LLP at (877) 779-1414 or info@consumerinjurylawyers.com for a confidential and free claim evaluation, or visit our consumer advocacy website, www.consumerinjurylawyers.com.
