Cutter Law P.C. is representing clients throughout California and nationwide who allege that they were severely injured by Medtronic’s Infuse Bone Graft. If you or a loved one has undergone spinal fusion surgery using Medtronic Infuse BMP-2 and experienced problems, you may be eligible to file a Medtronic Infuse lawsuit.
Across the country, patients are filing lawsuits against Medtronic Inc. after the Infuse Bone Graft was linked to serious side effects, including nerve damage, excessive bone growth and paralysis.
Infuse rhBMP-2 is a “bone morphogenetic protein,” which is a genetically engineered version of a human protein designed to promote bone growth. When combined with a collagen sponge and place inside a cage (fusion device), the bone graft is implanted into the spine and is supposed to eliminate the need for additional surgery.
The U.S. Food and Drug Administration (FDA) approved Infuse in 2002. It was given relatively limited approval in that it was authorized by the FDA only for use in single-level, lower-lumbar spinal fusions in which an anterior (through the stomach) surgical approach is used. The Infuse Bone Graft lawsuits allege that Medtronic downplayed or failed to notify doctors of the risks associated with the bone protein and illegally marketed Infuse for unapproved off-label uses.
In 2008, the FDA issued Medtronic a warning after receiving multiple reports of complications surrounding the Infuse Bone Graft. From 2004 to 2008, the FDA received more than 40 reports of complications stemming from the Infuse device. In September 2008, Medtronic reported that approximately 680,000 units of Infuse Bone Graft had been used in the United States. Additionally, it has been estimated that Infuse was used in over 100,000 spinal fusion surgeries on an annual basis from 2002 to 2013.
Side Effects From Infuse Bone Graft
In June 2011, the Spine Journal published a series of reports stating that Medtronic did not truthfully report the side effects of the liquid bone protein in its clinical trials. Experts in this study estimated that the incidence of adverse events in connection with Infuse’s use could range from 10 to 50 percent, depending on how it was used.
Side Effects Alleged By Infuse Patients Include:
- Radiculopathy or radiculitis: persistent radiating pain in the legs or arms
- Ectopic bone growth: excessive growth of bone in the spinal canal
- Nerve injuries that cause chronic pain
- Male patients have experienced sterility, retrograde ejaculation or other urogenital injuries
- Neck swelling after cervical spine surgery
As more injured individuals come forward, the scope and breadth of Medtronic’s negligence in indirectly marketing Infuse for off-label applications has broadened. While the total impact of its actions remains unknown, the recent surge of complaints filed against Medtronic suggests that there are still thousands of potential claimants suffering from Infuse-related injuries.
Complaints Filed Against Medtronic Accuse The Company Of:
- Manufacturing a defective product
- Failure to warn
- Negligence for faulty product design and manufacturing
- Failure to recall the defective product and fix the faulty design
- Fraud for misrepresenting the benefits of the device
- Concealing side effects
- Medical negligence
- Medical malpractice
Sacramento product liability lawyer Brooks Cutter has successfully litigated product liability cases against large manufacturers, including Medtronic, which is one of the world’s largest medical device makers. Brooks was appointed by the Federal Court to the Plaintiff’s Steering Committee in the Medtronic Sprint Fidelis product liability case, which settled for over $220 million.
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Give Cutter Law P.C. a call today to set up a free case review with one of our Sacramento product liability lawyers. Call toll free at 888-285-3333 or schedule a free consultation.