Scrutiny of Medtronic's Infuse bone graft product persists, this time as health insurer Humana alleges in a lawsuit that the medical-device manufacturer violated the federal racketeering statute by conspiring to work with physicians to illegally market the product off-label.
Many of the same allegations in the lawsuit, which was filed last week in U.S. District Court in Memphis, Tenn., appeared in a 2012 Senate Finance Committee report that looked at the role of Medtronic employees in editing and writing parts of studies published by doctors about Infuse, which is used in spine surgeries. Those physicians received millions of dollars in payments from Medtronic.
In its lawsuit, Humana argues that Medtronic knew that the insurer would rely on academic and peer-reviewed medical literature to set its coverage policies and that the company had paid millions of dollars for procedures for unproven off-label uses involving Infuse.
“Humana would not have paid such claims if it had known that defendants, while engaged in this deceptive enterprise, had tainted every credible and independent source of investigation available to Humana to conduct outside research about the benefits and efficacy of Infuse and/or BMP when compared to more traditional fusion approaches,” the insurer said in the lawsuit.
“The claims in this case are baseless,” a Medtronic spokesman said in an e-mail. “Medtronic stands behind Infuse Bone Graft and will continue to vigorously defend the product and our actions in court.”
A Humana spokesman declined to comment, citing the company's policy of not commenting on pending litigation.
Jeffrey Gibbs, an attorney at Hyman, Phelps & McNamara, told the Wall Street Journal that it was "very unusual" for a large health insurer to sue a devicemaker.
The move shows a tough tack by the insurer, and was potentially spurred by the large amount of money that had been spent on the Infuse product over the years. "The dollars at stake here are likely what helped shape this litigation," Gibbs said.
In recent years, the Justice Department and the U.S. attorney's office in Massachusetts opened investigations of off-label use of Infuse, which is approved to treat patients during anterior lumbar spine fusion surgeries. Both government entities closed their investigations in 2012, but Medtronic is also facing product liability lawsuits from about 1,000 patients, according to recent securities filings.
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