In 2008, the Minneapolis Firefighters’ Relief Association filed a Consolidated Class Action Complaint against Medtronic, Inc. maker of the Infuse® Bone Graft.1 The legal action resulted in an $85 million settlement.2
Parties to the class action lawsuit
A class action is a specific type of suit brought by a group ("class") whose members have similar legal complaints. The plaintiffs in the Medtronic Infuse class action were named collectively as the Minneapolis Firefighters’ Relief Association and included:
- Teachers Retirement System of Oklahoma
- Oklahoma Firefighters Pension Fund
- Union Asset Management Holding AG
- Danske Invest Management A/S
The plaintiffs filed suit for financial losses related to misinformation about the Infuse Bone Graft. They cited a number of company actions that were believed to have damaged the value of company stock. These included:
- Incomplete and misleading public statements
- Misleading statements about the Infuse Bone Graft as a source of increasing revenue to investors
- Failure to mention the Department of Justice settlement for the whistleblower lawsuits over alleged kickbacks to doctors to use and promote the product
- Failure to report the company’s push for off-label use of the product despite known side effects
- Misleading public statements made by Medtronic employees about its practices
Medtronic Infuse Bone Graft
The Medtronic Infuse Bone Graft3 was designed to treat serious back injuries when other treatments, such as medication, had failed. The Infuse Bone Graft was approved by the Food and Drug Administration (FDA) to treat lower back or lumbar degenerative disc disease, as well as scoliosis, bone fractures and other similar ailments.4
Infuse was not approved for cervical (neck) surgery. Warnings were issued by the FDA in 2008 about misuse of the product for this unapproved purpose. A number of complications, including male infertility, death, cancer, and nerve damage, began to surface around that time.5
Medtronic Infuse whistleblower lawsuits
One of the issues cited in the Minneapolis Firefighters complaint was that Medtronic failed to disclose settlements in several whistleblower lawsuits. These suits were filed against Medtronic under the False Claim Act, an anti-kickback law.6 In 2006, Medtronic paid a $40 million settlement to the Department of Justice to resolve the suits.7
$85 Million settlement
In March of 2012, the medical device giant agreed to settle the Minneapolis Firefighters’ Relief Association suit for $85 million, but did not admit to misrepresentation or wrongdoing.
Because the class action suit did not involve patients who had suffered physical injuries from the Infuse Bone Graft, they will not recover money from this settlement. However, individuals still have the right to file their own mass tort, personal injury and product liability claims against Medtronic related to Infuse.
If you or a loved one has suffered personal injury as a result of the Medtronic Infuse Bone Graft, you should seek legal advice from an attorney who specializes in mass torts, personal injury or product liability cases. This could save time and frustration as well as help protect your rights.