Health Insurer Humana Inc. is suing Medtronic Inc. alleging the device manufacturer paid $210 million to market its Infuse bone-graft drug to doctors for improper use. Humana claims the doctors then pushed the use of Infuse for use in certain neck and spine surgeries, which is not approved by the FDA. The health insurer is suing under the federal Racketeer Influenced and Corrupt Organizations (RICO) Act.
Humana says that they were tricked into covering costs for the unapproved uses. The lawsuit alleges that Medtronic paid the doctors to support use of the device through medical journals but hid its compensation of these doctors. The physicians are called “key opinion leaders” for their influence on other physicians.
The FDA approved the use of Infuse only in the lower-back, not neck or spine surgeries. Humana claims that they paid millions of dollars for Infuse that it would not have had to bear absent Medtronic’s improper marketing campaign and payments. Spinal surgeries are often very expensive and with difficult recoveries, so spinal operations and rehabilitation can cost upwards of $75,000 per patient.
The Humana lawsuit follows less than a month after a Medtronic settlement of $22 million for 950 lawsuit over the Infuse bone-graft system. Those cases cite the physicians’ promotion of Infuse in medical journals that overstated its benefits and understated its risks. Infuse side effects include development of cancer, uncontrolled growth, and sterility in men.
Lopez McHugh is currently investigating Medtronic Infuse lawsuits. If you have ongoing pain or other complications after use of a Medtronic Infuse procedure, contact a medical device attorney at Lopez McHugh to find out if you have an Infuse bone-graft claim.