Medtronic Infuse—Another Bone of Contention

Columbus, OH: Another Medtronic Infuse bone graft lawsuit has been filed against the company, again for providing misleading information about its bone graft product.

Humana, the health insurer, filed the false claims lawsuit on May 30 in the U.S. District Court, Western District of Tennessee (Humana Inc. v. Medtronic Sofamor Danek USA Inc., 14-cv-02405). According to Reuters, Humana said it paid for the Infuse product “when less expensive and more medically sound alternative procedures were available,” and that Medtronic misrepresented the Infuse product by “overstating benefits and minimizing serious risks,” with the intention of expanding the market.

The lawsuit further alleges that the giant medical device manufacturer sponsored academic publications that misrepresented Infuse bone graft and paid doctors to promote the Medtronic bone graft product as safe to use in different spinal surgeries, i.e., off-label, even though the FDA only approved it in 2002 for lower-back procedures.

Humana claims that Medtronic paid $210 million to a number of physicians (known as “key opinion leaders” because they can influence the types of products and procedures that other physicians use) who advocated the drug’s use in certain neck and spine surgeries that hadn’t been approved by the FDA, according to the Wall Street Journal (June 2, 2014). Medtronic then worked to cover up the physicians’ payments.

Humana also claims in the lawsuit that Medtronic committed fraud, “negligent misrepresentation” and other violations of law.

In late 2012, Medtronic was charged by the Senate Finance Committee of paying off doctors to author medical journal pieces that downplayed or even ignored serious risks and Medtronic Infuse side effects. The Committee’s lengthy and in-depth report found that Medtronic had paid more than $200 million in royalties to doctors who wrote favorably in medical journals about Infuse. The payments covered a 15-year period, beginning in 2002, soon after the product was placed on the market.

In March 2014, Medtronic said about 1,000 people have filed Infuse bone graft lawsuits, and the company expected more to come. In an e-mail to the Wall Street Journal, Medtronic spokesman Eric Epperson stated that “Medtronic does not compensate physicians for the use or endorsement of our products, and disagrees with any suggestion to the contrary.” Instead, the payments to doctors were related to the doctors’ intellectual-property rights. Humana doesn’t see it that way.