Medtronic Infuse Bone Graft lawsuits are becoming common and necessary. The Medtronic Bone Graft is used during surgery in order to stimulate bone growth and try to replace damaged spinal discs. The Medtronic Infuse Bone Graft was marketed and sold as an alternative to taking a bone graft from the patient’s hip. Even though the Medtronic Infuse Bone Graft is not approved for any other uses it has been used, and promoted by Medtronic, off-label in cervical spine and neck procedures. The Medtronic lawsuits are are being directed to Multidistrict Litigation (MDL) much like defective vaginal mesh cases and defective Stryker hip replacement cases.
The FDA granted Medtronic approval for a limited use of its Infuse Bone Graft in the lumbar spine, or lower back. The FDA also approved it for some dental procedures. The FDA approved the Infuse Bone Graft for the treatment of degenerative disc disease as well as to treat open fractures on the tibia. The FDA also approved the Medtronic Infuse Bone Graft to be used in procedures involving sinus augmentation or localized alveolar ridge augmentation.
The Medtronic Bone Graft procedure works by using recombinant human Bone Morphogenetic Protein (rhBMP), rhBMP is a genetically engineered version of a protein that is naturally in a person’s body. The Medtronic Infuse bone growth stimulator has been associated with many problems, including: difficulty breathing, swallowing or speaking, nerve damage, respiratory problems and death.
After many reports of complications, the FDA issued a warning concerning off-label Medtronic Infuse Bone Graft use. The FDA warned doctors and patients about the risks that were associated with the use of the bone graft on the cervical spine. The FDA’s warning stated, “that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.”
The Wall Street Journal has reported that FDA records showed many instances where patients experienced serious complications after the bone graft was used off-label. The Wall Street Journal has reported that some doctors who used the bone graft system or who wrote favorable reports about the Medtronic Bone Graft have been paid by Medtronic. The Wall Street Journal reported that Medtronic paid approximately $800,000 over three years to one surgeon who has been accused of forging a study to report good results for the Infuse Bone Graft.
The doctor, Timothy R. Kuklo, allegedly based the study on fake information and forged the signatures of co-authors. Medtronic claims that the payments were related to the doctor’s work developing products and speaking at company events.
In mid 2011, The Spine Journal published a number of articles regarding the risks of Medtronic’s Infuse Bone Graft, including the following: Medtronic’s failure to report that many of the authors who studied and promoted its product had significant financial ties to the company, that the Infuse Bone Graft can cause severe problems with both the nerves and spinal cords of patients, the Medtronic failure to accurately report the side effects from its clinical trials as well as the fact that off-label use of the Infuse Bone Graft can lead to severe side effects.