Medical device manufacturer Medtronic Inc. is currently fighting thousands of lawsuits alleging the company promoted its Infuse bone graft system — used in over 100,000 spinal fusion surgeries a year — for off-label purposes. As a result, patients allegedly suffered severe complications such as chronic pain; excessive bone growth; nerve damage; difficulty breathing, speaking or swallowing; and male sterility.

The Infuse bone graft system is a bone-growth protein used in spinal fusion surgery. Lawsuits allege Medtronic paid researchers millions of dollars to publish white-washed research that minimized the risks of Infuse. Medtronic denies the allegations.

In October, a federal judge allowed a securities class action lawsuit to proceed that accuses Medtronic of manipulating studies about the safety of Infuse. Investors claim these doctored studies misled them about Medtronic’s financial situation and artificially drove up stock prices.

Several months earlier in May 2014, Medtronic announced it would settle nearly 950 Infuse bone graft lawsuits for $22 million, and would set aside an additional $120-$140 million to resolve over 3,000 additional lawsuits. Plaintiffs are suing Medtronic for fraudulently misrepresented the safety of Infuse and are seeking compensation for medical expenses, pain and suffering, and other damages.

Overview of Infuse Bone Graft

Medtronic is is the country’s largest medical device maker. Every year, more than 100,000 patients go under spinal fusion surgery in the United States, using the Infuse bone graft.

At the time the Infuse bone graft was approved in 2002, it was advertised to be an easy and efficient alternative method for spinal fusion surgery, which required harvesting bone marrow from the patient’s knees. The Infuse consists of a synthetic human bone morphogenetic protein (rhBMP-2), which promotes bone growth.

Ideally, the Infuse bone graft would allow the bones to naturally grow and fill in excess space as needed. Unfortunately, this reportedly has not been the case for thousands of patients who allege they suffered severe Infuse bone graft complications, allegedly due to Medtronic’s false advertising.

Lawsuits allege Medtronic marketed the Infuse bone graft to be used for unapproved surgeries, which caused a variety of complications:

• Difficulty breathing, speaking and swallowing
• Chronic pain requiring daily medication to manage
• Excessive bone growth
• Nerve damage
• Male sterility and other uro-genital injuries
• Death