Medtronic Infuse Bone Graft Settlement Reached

A Medtronic INFUSE bone graft settlement was recently announced, with the medical technology company agreeing to pay $22 million to settle approximately 1,000 legal claims over the controversial spine surgery product. Medtronic is also setting an additional $140 million aside to fund an even larger number of expected claims.

The INFUSE ─ including the biologic drug BMP-2 ─ was approved by the U.S. Food and Drug Administration in 2002. It was introduced as an alternative to conventional spinal fusion, which would typically require spine surgeons to take a small amount of bone from the patient’s hip.

More than one million patients worldwide have been implanted with the Infuse, with annual sales reaching approximately $800 million.

Medtronic INFUSE bone graft settlement

Not long after the INFUSE bone graft received FDA approval, a small group of prominent spine surgeons began to co-author papers published in medical journals failing to associate the product to a number of serious complications, such as cancer, the growth of unwanted bone, and a medical issue that can cause men to become sterile. This resulted in a review and criticism of the Infuse papers by a group of doctors who published the results of their own research in the Spine Journal in 2011.

The U.S. Senate Committee on Finance began a concurrent investigation and issued a report in 2012 stating that Medtronic marketing workers were secretly conspiring to write and edit articles promoting the Infuse in a favorable manner, as the company paid millions of dollars to the surgeons whose recommendations added merit to the reviews.

The company’s quiet manipulation of data on the product overstated its benefits and made light of serious complications, noted the Senate report.

Medtronic paid $210 million in royalties and other payments to a group of 13 doctors and two corporations over a 15 year period, including $34 million to University of Wisconsin orthopedic surgeon Thomas Zdeblick, who co-authored a number of papers promoting the Infuse.

Many lawsuits accuse Medtronic of illegally promoting the product for uses not approved by the FDA, through its payments to spine surgeons.

More claims expected to be filed

While Medtronic settled the claims of nearly 1,000 plaintiffs with the $22 million settlement, roughly 750 cases filed by 1,200 people are still pending in U.S. courts.

Additionally, the company expects approximately 2,600 more claims to be filed.

About the INFUSE bone graft

The Infuse bone graft device was designed to help fuse vertebrae in the lower spine to treat degenerative disc disease. Rather than using a graft of the patient’s own bone, it uses genetically engineered protein to help build bone tissue in the fusion process.

The INFUSE device consists of three different modules, split among two parts:

• a metallic tapered spinal fusion cage
• a bone graft substitute, consisting of a genetically-engineered human protein with a carrier/scaffold for the protein that is placed inside the fusion cage.

The fusion cage module is designed to maintain the spacing and temporarily stabilize the diseased portion of the spine, while the Infuse Bone Graft module works to form bone to permanently stabilize this portion of the spine.

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