More than a thousand patients have filed more than 700 lawsuits against medical device manufacturer Medtronic over its Infuse synthetic bone growth product, according to a review of the controversy.
The company's recent financial reports have speculated that more lawsuits in federal and state courts may be on the way, and that attorneys general in California, Illinois, Massachusetts, Oregon and Washington have subpoenaed documents regarding Medtronic's sales and marketing of the product.
"Medtronic stands behind Infuse bone graft and will vigorously defend it in court," said a company spokesperson, who pointed out that the suits have yet to be litigated, and that none to date have found Medtronic liable.
Infuse, which offered a synthetic alternative to natural bone grafts in spine fusion surgery and which was reportedly often applied to off-label uses, has been at the center of scientific and legal debates for years.
Studies touting the material have been called into question after it was revealed that the company paid 13 physician-researchers $210 million over the course of 15 years, a move which spurred an investigation by federal lawmakers.