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Infuse Bone Graft / Courtesy of Medtronic plc

Medtronic Settles With 5 AGs Over Infuse

Walter Eisner • Wed, December 20th, 2017

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Maura Healey, the Attorney General (AG) of Massachusetts, said on December 13, 2017 that Medtronic plc has agreed to pay $12 million to resolve claims that the company used deceptive marketing practices to promote Infuse Bone Graft in spinal surgery.

The settlement resolves an investigation by the AG's office and four other states.

According to court documents reported by Reuters, Healey accused Medtronic of using deceptive company-sponsored scientific literature to make false and misleading claims about the product's safety and superiority.

Healey claimed the company paid millions of dollars in consulting fees to doctors to publish studies that the company then disseminated downplaying side-effects and omitting discussion of adverse results.

"Companies cannot use deceptive practices to increase their profits, while compromising the safety and well-being of patients," Healey said in a statement.

Medtronic Denies Wrongdoing

Medtronic did not share the AG's sentiments and, according to court documents, said nothing in the deal could be taken as a concession that it violated the law. It did not admit wrongdoing.

In an email to the Minneapolis Star Tribune, a company spokeswoman wrote, “Medtronic entered into an agreement with state Attorneys General…to resolve their inquiries into our promotional practices related to Infuse Bone Graft in their states. …This agreement brings closure to this matter.”

Under the settlement, two Medtronic units will pay $12 million to resolve an investigation by attorneys general in Massachusetts, Oregon, California, Illinois and Washington.

The settlement also reportedly imposes requirements on how Medtronic promotes clinical trial information and disseminates medical journal articles related to Infuse. The company must also make Infuse trial data public on a government website.

Settled Private Claims

Medtronic has faced more than 6,000 lawsuits nationally by people who claimed they suffered injuries after receiving Infuse for off-label uses.

In a June 27, 2017 10K filing with the Securities Exchange Commission (SEC), the company announced agreements with approximately 6,000 claimants. The company also said it has set aside $300 million for “certain litigation charges” in the filing.

The company had previously disclosed reaching settlements in more than 4,000 Infuse patient lawsuits. In December 2016, a judge in St. Louis cleared the way for the first jury trial involving personal injuries allegedly caused by Infuse. That trial could have opened sealed internal documents that could have been used in other trials.

According to the Star Tribune, the company paid at least $85 million in a settlement to shareholders in 2012 to resolve allegations that it failed to reveal that most sales of Infuse were for off-label surgeries. In 2014, Medtronic said it paid $22 million to 950 injured Infuse patients. The company denied wrongdoing in each settlement.

As we commented in the December 19 Power Rankings, these settlements are more reverberations from that disastrous The Spine Journal Carragee mistake. And it's Medtronic cleaning up the mess.

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