Medtonic is a large research company that holds itself out as a company that creates new and innovative ways to treat and rehabilitate patients around the world. This is true. But, too often, their innovation flops miserably because they put a product on the market that is not ready, or because they push a product to be used in ways that it should not be used.
In 2002 they introduced an Infuse Bone Graft procedure that uses recombinant human bone proteins to foster the growth and connection of broken bones. It is currently approved for use in anterior lumbar interbody fusion, tibial fractures, and sinus augmentations.
In 2011 Medtronic was under investigation by the United States Senate and the Department of Justice for promoting off-label use and for suppressing negative testing results. The bone grafts have been allegedly linked to numerous complications such as an increased risk of cancer. Other patients have experienced heterotopic (unwanted bone growth) that causes pain and further complications. The bad reputation has already begun to influence the sales; the company reports $528 million for 2013 compared to 2012’s $800 million.
Yale Safety Review
In an attempt to stave off allegations of the graft’s dangerous side effects – and the suits being filed by patients around the country – Medtronic paid Yale University 2.5 million dollars to conduct a study on the product’s safety. The results, released in June 2013, were mostly negative. While showing an increased fusion rate, the graft did not perform any better at reducing pain than its alternatives. The Infuse surgery had a greater problem rate than traditional grafts. It additionally had a distinct increase in the risk of cancer. Those who benefit most from the Infuse transplant are those who cannot use their own bone material.
Medtronic has a history of paying doctors to say nice things about them. But I guess Yale is Yale. They played it straight. And the results don’t look so good for Medtronic.
Off-label Advertising Lawsuits
After the Yale safety review was released, a new type of lawsuit has been filed against Medtronic. Plaintiffs in California claim that Medtronic has repeatedly ignored the FDA’s warning against the promotion of off-label uses of the product. There is evidence that the company provided “kickbacks” and other incentives to doctors that recommend the use of Infuse Bone Graft in not approved situations. The injured seek punitive damages and disgorgement of profits from the alleged failure to warn, manufacturing and design defect, negligence, fraud, and intentional misrepresentation.
Filing a Lawsuit
If you have used Medtronic Infuse for bone growth and have gotten cancer, sterility, or experienced swelling, protect your rights. Call us at 800-553-8082 or talk to us online. There is no fee or cost for you in pursuing your claim unless you win a recovery.