A Florida woman has filed suit against Medtronic, claiming off-label use of its <"http://www.yourlawyer.com/topics/overview/Medtronic_Infuse_Bone_Graft">Infuse Bone Graft product caused her to suffer serious injuries. The plaintiff in the lawsuit, Jennifer English of Lake Worth, alleges Infuse resulted in the development of ectopic, or uncontrolled, bone growth in her spine, compressing nerves and leading to chronic and ongoing severe pain.
Infuse, a spine product made from recombinant human Bone Morphogenetic Protein or rhBMP-2, was approved by the U.S. Food & Drug Administration (FDA) in 2002 as a treatment for anterior approach lumbar fusion. In July 2008, the FDA warned that Infuse Bone Graft and similar products had caused serious problems when they were 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.
According to her lawsuit, English received Infuse during a posterior-approach lumbar spine surgery, a type of surgery for which the FDA has not approved Infuse. Since then, English has been forced to undergo two revision surgeries – including an emergency procedure – to remove the excessive bone growth. Her complaint alleges that due to Infuse, English suffers continuous pain in her back and legs from ordinary everyday activities, such as sitting or standing for extended periods of time.
Off-label use of FDA-approved medical products is not illegal, but manufacturers like Medtronic are legally barred from promoting such uses. Doctors must also inform their patient when a device is being used off-label, and all risks must be fully disclosed to the patient.
Infuse has long been a subject of controversy. Over the summer, we reported that several Medtronic-funded Infuse clinical trials were called into question by a review in The Spine Journal. The Spine Journal, which took the unprecedented step of devoting a whole issue to rhBMP-2, charged that the Infuse clinical trials downplayed its association with serious side effects, including male sterility, infection, bone loss and unwanted bone growth. At the same time, the journalâ€™s editors criticized Medtronic for failing to disclose that it had paid many of the researchers involved in the trials millions of dollars in consulting fees.
The U.S. Senate Finance Committee has been investigating Infuse for several years, and recently demanded Medtronic turn over records detailing payments made to Infuse researchers. Meanwhile, the U.S. Justice Department is investigating off-label use of Infuse.