Medtronic Facing Lawsuits Over Bone Growth Product

Medtronic has confirmed that around 1,000 people have sued the company over complications arising from its controversial bone graft product, Infuse.

Infuse, which first entered the market in 2002, is a biological substance that stimulates bone growth. Also called bone morphogenetic protein-2(BMP-2), the product has been used in more than 1 million spinal operations, according to an investigative article published earlier this week by the Milwaukee Journal Sentinel.

Experts who have studied Infuse suspect that the majority of lawsuits are in response to complications arising from the product’s two most common side effects: unwanted bone growth and sterility in men.

It has also been estimated that upwards of 85 percent of those who have received Infuse treatments did so through unapproved, off-label channels.

“When you start using a product 85 percent off label, there are going to be problems,” said Dan Spengler, an orthopedic surgeon at Vanderbilt University. 

According to the Journal Sentinel, many researchers familiar with Infuse are concerned that the recent batch of lawsuits is yet another episode in an ongoing history of controversy surrounding the product.

John Fauber, author of the article, explained: “The patient lawsuits, which were detailed in a recent securities filing by the company, are the latest development in a decade-long saga of a product that has been the center of investigations, both scientific and legal, and has been linked to conflicts of interest among doctors who wrote favorable articles about it while at the same time taking in millions of dollars in royalties from the company.”

Beginning in 2002, shortly after Infuse first hit the market, doctors who would receive large royalty payments from Medtronic for using other Medtronic spine products began publishing articles in medical journals praising Infuse, according to the Journal Sentinel.

Then in 2011, The Spine Journal published a critical review of Infuse, citing “reports of frequent and occasionally catastrophic complications associated with use of [BMP-2] in spinal fusion surgeries.”

Finally, in 2013, two independent studies concluded that Infuse could lead to serious side effects and offered little benefit over other, more conventional forms of spine surgery.

According to the Journal Sentinel, over the course of 15 years, Medtronic has paid $210 million to a group of 13 doctors as well as two corporations directly linked to doctors, many of whom have co-authored a series of journal papers positively reviewing Infuse.

Medtronic spokeswoman Cindy Resman issued a statement earlier this week highlighting the fact that the lawsuits remain in early procedural stages. She also pointed out that the filings had yet to result in a finding of liability against the company.

“Medtronic stands behind Infuse bone graft and will vigorously defend it in court,” Resman said.

Richard Deyo, a professor of family medicine at Oregon Health & Science University who has spent time researching Infuse, as well as other medical products, remains skeptical. He told the Journal Sentinel that the Infuse-related lawsuits remind of him other highly touted medical products that quickly made their way onto the market and were later discovered to be harmful to patients.

“My cynical view is that companies view this as the cost of doing business,” Deyo said about the lawsuits.