Medtronic agrees to settlement with five states in Infuse case

Medtronic has agreed to pay $12 million to five states to resolve a lawsuit that accuses the medical device company of misleading doctors and the public about the safety of a controversial bone-growth product that has been blamed for thousands of patient injuries.

Medtronic admitted no wrongdoing when it agreed to settle the complaint from the five states over its biotech product Infuse, which contains a genetically engineered version of a human bone-growth protein used during spine-fusion surgery.

Oregon Attorney General Ellen Rosenblum said Wednesday that Medtronic Sofamor Danek USA, a unit of Minnesota-run Medtronic, has agreed to settle allegations that the company broke state laws by secretly manipulating journal articles to make Infuse appear safer than it was and then using those upbeat reports to sell more of the product.

"It is unacceptable for a company to use company-sponsored literature with misleading data to try to show that its product is more effective than other therapies," Rosenblum said in a news release. "By using these misleading claims, the company created a higher demand for Infuse."

The states sharing in the settlement are California, Illinois, Massachusetts, Oregon and Washington. More than 6,000 patient lawsuits and potential lawsuits are still pending against Medtronic relating to Infuse, as well as investors' lawsuits. One of the investor cases, Kokocinski v. Collins, was recently appealed to the U.S. Supreme Court, which is expected in early January to consider whether to grant oral arguments.

In the five-state investigation resolved Wednesday, Medtronic in court records expressly denies the allegations.

"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," a company spokeswoman said via e-mail Wednesday.

Injured patient Brigitte Whitted said the monetary settlement with the states seemed small, compared to how much damage Infuse has wrought in patients like her.

The 56-year-old central Florida woman said she was disabled after Infuse was used in an unapproved way during her spine surgery nine years ago, causing bony overgrowth in her spine, additional surgery, chronic weakness and pain. She said she was never told Infuse was used on her in a non-FDA-approved way or that it had potentially deadly side effects. Although she sued Medtronic, she turned down the settlement offer since it wouldn't even cover her medical bills.

"This has been going on for so long, and all they got was a slap on the wrist," Whitted said Wednesday. "I was a full-time employee, and now I am on [government-paid] disability."

Medtronic CEO Omar Ishrak has defended the scientific research that Medtronic sponsored to show the Food and Drug Administration that the product was safe and effective for the narrow uses for which it was approved in 2002.

The company has long denied allegations that it has promoted Infuse for uses not approved by the FDA, even when Medtronic personnel were in the operating room while it was being used in unapproved ways. While it's legal for doctors to use products like Infuse in ways not approved by the FDA, companies cannot promote such uses.

The Star Tribune reported last year that Medtronic failed to tell the FDA about the patient injuries and product malfunctions that it learned about through a 3,600-patient in-house 2007 study of mainly unapproved uses of Infuse. Medtronic executives acknowledged the reports should have been handed over within 30 days of the company learning of them.

The database of post-surgical problems was turned over to the FDA in 2014. The database's existence was publicly disclosed in an unusual format that hid the number of problems from the public until a key redaction was lifted in 2015, revealing that the long-lost study had documented more than 1,000 post-surgical problems among 3,600 patients.

A Star Tribune analysis of FDA filings found that by the end of 2007, while Medtronic was failing to report more than 1,000 adverse events following Infuse surgeries, there were only about 300 adverse event reports on file with the FDA in total. The FDA warned the public in 2008 to avoid using Infuse in upper-spine fusion surgery because of life-threatening complications like dozens that were documented, but not disclosed, by Medtronic in 2007.

The Oregon settlement focuses on studies that were published and Medtronic's practice at the time of making undisclosed payments to the study authors. The complaint says Medtronic brought those articles into Oregon, where they were used to promote Infuse in ways that allegedly violated the state's Unlawful Trade Practices Act.

Specifically, the complaint alleges that Medtronic misrepresented which uses of Infuse were approved by the FDA, overstated scientific findings about Infuse in marketing, and misrepresented Infuse's risks, all of which had the effect of deceiving or misleading consumers.

Medtronic denied each of those allegations.

A company spokeswoman wrote via e-mail, "Medtronic entered into this agreement solely for the purpose of settlement, and nothing related to it can be taken as an admission or concession of any violation. ..."

Although use has declined, Infuse is still used in thousands of spinal surgeries per year to eliminate back pain by fusing painful spine bones together. Much of that use happens in ways never approved as safe by the FDA. The product does have several FDA-approved uses in the spine and elsewhere in the body, and Medtronic launched new studies this year to potentially expand the approved uses.

Joe Carlson • 612-673-4779

Jim Spencer • 202-662-7432