Medtronic Announces Infuse Settlements

Medtronic plc says it has reached an agreement with “substantially all” remaining claimants involving the Infuse bone graft product.

In a June 27, 2017 10K filing with the SEC, the company announced the 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 Minneapolis 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.

Remaining Investigations

While the announcement settles private claims, the company is still under investigation by various state attorneys general who have issued subpoenas or document requests in Massachusetts, California, Oregon, Illinois, and Washington seeking more information regarding the Infuse device.

“We continue to cooperate in the State AG inquiries and are hopeful an acceptable resolution can be reached,” Medtronic spokesperson Eric Epperson told the Tribune.

Humana RICO Suit

There also remains the 2014 Humana, Inc. lawsuit alleging that Medtronic violated federal racketeering (RICO) law and various state laws, by conspiring with physicians to promote unapproved uses of Infuse. In September 2015 the court granted Medtronic’s motion to dismiss the primary allegations, including the RICO claims, in Humana’s complaint. In April 2016, the Court denied Humana’s motion to file an amended complaint.

Trust

Infuse has been a financial success for the company, reaching sales of almost $1 billion in one year. But after accusations that the company failed to disclose adverse events and allegedly paying surgeons to publish studies, the public relations costs were high. The U.S. Senate held hearings into the matter, with no result.

The company then partnered with the Yale University Open Data Access (YODA) Project to put its data sharing model in practice for the first time to study and release all the company’s clinical research data related to Infuse. The YODA Project led independent, systematic reviews of the entire body of scientific evidence regarding the safety and effectiveness of Infuse. The reviews were conducted by two independent academic teams with full access to all Medtronic’s clinical trial, post-marketing and safety data. In addition, the grant supported the dissemination of all Medtronic clinical research data on Infuse to external investigators from June 2013-June 2015.

The YODA Project found no significant difference between Infuse and traditional bone graft.

The Infuse saga will be a defining moment in the history of spine industry-surgeon relationships, the transparency of studies, and the off-label use of products. The episode caused physicians of all specialties to question who to trust when it comes to published studies.