Various attorneys across the United States are working to gain settlements that fairly compensate victims of the Medtronic Infuse. Lawsuits concerning the product’s usage began after a barrage of complaints from patients and patients’ families. Doctors began to use the product in unapproved procedures that dealt with the cervical spine and neck. Patients were overcome with severe side effects including difficulty swallowing, labored breathing, abnormal bone growth, and sterility. Some patients have died from these as well as other serious reactions to the product. Complications related to Infuse have started between a period of 2 days to 14 days after surgery.
The US Food and Drug Administration originally approved the bone graft for use in treatments of degenerative disc disease, open fractures of the tibia, augmentations of the sinus, and the alveolar ridge. In July of 2008, the administration sent out a warning about Infuse and the risks involved with its misuse after being alerted to patient problems. Over 38 complaints were received over a 4 year period. This off label use of Medtronic Infuse is also responsible for an ongoing United States Department of Justice investigation. A senate committee convened to examine the possibility that a number of doctors knew about the harsh side effects. The committee contacted Medtronic for financial records, documents, and communications related to Infuse. Advisors for the Food and Drug Administration approved the product by a narrow margin. Researches from Yale are also conducting an independent study into the Medtronic Infuse.
Serious accusations have been made against Medtronic as well as various doctors. Several reports indicate that these doctors involved with the Medtronic Infuse were receiving payments from the company to use the graft. Allegations also state that certain doctors went as far as falsifying information for pay. Select doctors were chosen to speak at company sponsored promotional events. This extends to select researchers who may have been compensated millions in consulting fees. These fees were never fully disclosed to FDA officials or the public.
Former employees of Medtronic also began lawsuits against the company. Two of these lawsuits have been settled with the company admitting no wrong doing. Another lawsuit alleges improper usage of the bone graft. Some shareholders have lawsuits pending concerning illegal advertising of the product.