Company misrepresented its Infuse bone growth product as safe and effective in spinal fusion surgeries. Managed care company Humana Inc. has filed a lawsuit against medical device maker Medtronic, alleging the company misrepresented its Infuse bone growth product as safe and effective in spinal fusion surgeries.
The suit was filed on Friday in federal court in Tennessee, and alleges that Medtronic paid for academic studies that fraudulently portrayed the product as safe and effective for uses not approved by the Food and Drug Administration (FDA), Reuters reports. Humana said it paid for Infuse procedures when less expensive and more medically sound alternative procedures were available.
The lawsuit says Medtronic employed a “sophisticated and deeply deceptive marketing strategy” to expand the market for Infuse and that Medtronic overstated Infuse’s benefits while minimizing serious risks. Medtronic said the company did not improperly influence peer-reviewed publications and that it had compensated physicians for legitimate consulting services to the company, according to Reuters.
Infuse receives FDA approval in 2002 for use in spinal fusion
Infuse received FDA approval in 2002 for use in spinal fusion, a surgical procedure to reduce back pain. Infuse contains the genetically engineered protein recombinant human bone morphogenetic protein 2 to promote bone growth. Infuse was hailed as an alternative to painful bone harvesting from other parts of the body to perform a bone graft, according to Reuters. Early reports in medical journals claimed superior results for Infuse surgery, but in 2008, the FDA warned of reports of life-threatening complications in off-label uses, such as fusions in the upper (cervical) spine.
In 2011, an entire issue of Spine Journal was devoted to critiques of Medtronic-funded Infuse research. Spine said the research did not report serious complications including infections, increased cancer risk, male sterility, bone dissolution, and worsened back and leg pain, according to Reuters. Infuse became the subject of investigations by the U.S. Senate and Department of Justice over off-label use of the product and omissions of safety problems from its clinical trial data.
Medtronic agreed to release its clinical data for independent reviews overseen by Dr. Harlan Krumholz of Yale University. “Overall,” Dr. Krumholz concluded, “they failed to find a big benefit,” for Infuse over a bone graft using bone from the patient’s own body.