Cleveland, OH (PRWEB) August 08, 2012
Spangenberg Shibley & Liber is now investigating cases involving individuals injured from the off-label use of Medtronic’s Infuse Bone Graft system in cervical spine procedures. Medtronic is accused of marketing the Infuse Bone Graft system as safe and appropriate for off-label use and downplaying side effects. (http://spine.org/Documents/TSJJune2011_Carragee_etal_Editorial.pdf)
The U.S. Food and Drug Administration approved the Infuse Bone Graft in 2002 for use in spinal fusion procedures. Any use other than what the FDA approves is considered “off-label.” Healthcare professionals have the discretion to use medical devices in any manner they see fit; however, manufacturers do not have the authority to market a device for off-label use. Manufacturers should instead seek additional use approval from the FDA.
Roughly 85 percent of all procedures using the Infuse Bone Graft system were off-label, especially for cervical spine procedures, according to the Wall Street Journal. In 2008, the FDA warned the public that using the Infuse Bone Graft for cervical spine procedures is not permitted and can pose serious side effects and complications. The agency reportedly received 38 complaints alleging the system caused:
- Uncontrolled bone growth
- Male infertility
- Chronic pain
- Swelling of the neck and throat
- Trouble breathing, swallowing, speaking
- Closed airway
- Respiratory depression
- Nerve damage
These complications were seen in 10 to 15 percent of patients from 13 clinical trials over the course of 10 years but were concealed, according to a study published in The Spine Journal. (http://spine.org/Documents/TSJJune2011_Carragee_etal_CriticalRev.pdf)
In 2008, the Department of Justice began looking into whether Medtronic marketed the Infuse Bone Graft system for off-label use in cervical spine procedures after the FDA reportedly received 280 complaints involving the system. At least one-third of those complaints were related to off-label use. (http://spine.org/Documents/TSJJune2011_Carragee_etal_CriticalRev.pdf)
One study, published in the Journal Sentinal and MedPage Today, found that using high amounts of recombinant human bone morphogenetic protein, or rhBMP-2, could raise the risk for several types of cancers including stomach, thyroid, breast, skin, ovarian, lung, leukemia, prostate, laryngeal, lymphorna, and pancreatic cancers. (http://www.medpagetoday.com/Orthopedics/Orthopedics/29468)
In 2011, the Senate Finance Committee launched an investigation of several doctors that Medtronic paid to downplay the side effects and complications associated with the Infuse Bone Graft system. Fifteen of those doctors were allegedly paid at least $62 million combined for unrelated work within 10 years. Medtronic allegedly admits to paying one doctor $800,000 over the span of three years to fabricate a study (using a fake control group) that reported inflated results with the Infuse Bone Graft. (http://spine.org/Documents/TSJJune2011_Carragee_etal_CriticalRev.pdf)
Medtronic’s Infuse Bone Graft was approved to treat degenerative disc disease in the lower region of the spine. The system uses a bioengineered synthetic protein known as recombinant human bone morphogenetic protein, or rhBMP-2, to mimic a protein found in the body and aid in bone formation and growth. A sponge-like device made of bovine Type I collagen is used to provide a framework for the bone to grow in, distribute rhBMP-2, and then dissolve once the bone has grown.
The New York Times writes that spinal fusion procedures are performed on an estimated 80,000 patients per year. At least half of those used the Infuse Bone Graft system. (http://www.nytimes.com/2011/05/25/business/25spine.html?_r=2)
About Spangenberg Shibley & Liber
Spangenberg Shibley & Liber handles a broad range of dangerous drug, personal injury, medical malpractice, nursing home and elder abuse and civil rights cases. The firm also litigates a variety of property damage and insurance coverage cases. For more information about the firm, please contact marketing manager Miranda Miller at 216.696.3232 or visit spanglaw.com.