Healthcare News & Insights

Medtronic stands behind its bone graft product despite 700 lawsuits

Medtronic, the world’s largest medical technology company, is being sued by nearly 1,000 people, and it’s predicted that many more lawsuits are on the way. So why are so many people unhappy with the medical technology giant?

166843203It has to do with its bone morphogenetic protein-2 (BMP-2), Infuse.

Infuse is a biologic agent that stimulates bone growth and has been implanted in the spines of more than 1 million people. According to Medpage Today, most of these people got Infuse in “unapproved ways” — as much as 85% of BMP-2 use has been off-label.

Questions were raised in 2013, by two independent reports, about the possibility that the product was linked to serious adverse events including cancer and sterility in men.

It’s also been found to cause unwanted bone growth.

Dr. Dan Spengler, a Vanderbilt University orthopedic surgeon, interviewed for the Medpage Today story, suspects that many of the lawsuits involve people who have experienced excess bone growth after an off-label use in surgery.

Standing by its product

In a company statement, Cindy Resman, company spokesperson for Medtronic, said “Medtronic stands behind Infuse bone graft and will vigorously defend it in court.” She also said the lawsuits are in the early stages and so far none of them have found Medtronic liable, but some have been dismissed.

Recently, the lawsuits were detailed in a securities filing by the company.

But scrutiny of Medtronic’s Infuse isn’t new, it’s just the latest development in a 10-year saga.

The product has been under investigation both legally and scientifically.

One issue at hand is the validity of Medtronic’s research. According to the Medpage Today article, research on Infuse was done by physicians who received million of dollars in royalties from Medtronic and published highly favorable articles on the product.

And to top it off, several states are investigating the sales and marketing practices involving Infuse.

So far the company is fully cooperating with subpoenas and document requests from government bodies, including civil investigations from five state attorneys generals.

We will keep you posted.

Subscribe Today

Get the latest and greatest healthcare news and insights delivered to your inbox.