What can go wrong with an Infuse Bone Graft?

From chronic pain and abnormal bone growth to tissue or nerve damage, the side effects can be debilitating. All too frequently, they were never disclosed to patients prior to a surgery.

The technique avoided the need to use material from a patient’s own bones by substituting bovine collagen. It was designed to speed up a graft surgery and minimize pain and recovery time.

But allegations have surfaced that the company may have downplayed and covered up health problems or serious side effects associated with the Infuse Bone Graft. Some of these problems relate to off-label use, marketing practices and the failure to warn.

A case moves closer to trial

As many as 6,000 Infuse injury claims are pending against Medtronic, the maker of the Infuse Bone Graft. A SEC document disclosed that the company had spent more than $100 million on settlements. It expected to reach negotiated settlements in about 4,300 of the pending cases, but anticipated litigation to resolve the others. None have yet gone to a jury trial.

That could be about to change. A St. Louis judge cleared the way for a February jury trial by refusing to dismiss or transfer a claim. The case could bring many sealed records into the light of day.

The plaintiff asserts that the records prove she “would have received different medical treatment if [Medtronic] had adequately warned of the dangers of Infuse.” Some of the records include marketing materials, studies, e-mails and depositions from the plaintiff’s doctor as well as officers at Medtronic. The discovery could contain tens of millions of documents.

Marketing of Infuse has not only come up in products liability lawsuits, but has also been investigated by the U.S. Justice Department and five state attorneys general. Reporting of complications in company-run studies was also improperly delayed.

Legal cases related to medical device failure require the help of an experienced law firm with the resources to conduct significant investigations. If you suffered a serious side effect after receiving an Infuse Bone Graft or other medical device, ask an attorney to review your case.