Medtronic Infuse Class Action Lawsuit Filed Over Misleading Statements

Medtronic faces a new class action lawsuit involving their Infuse bone graft, with investors alleging that the company issued misleading statements about the safety of their controversial product, and that medical studies were tampered with to downplay the potential risk of complications from Medtronic Infuse surgery.  

West Virginia Pipe Trades Health & Welfare Fund filed the complaint (PDF) in the U.S. District Court for the District of Minnesota on June 27, seeking class action status to include all individuals or entities who bought common stock of Medtronic, Inc. between December 8, 2010 and August 3, 2011.

According to allegations raised in the Medtronic Infuse class action, the manufacturer provided false information about the effectiveness and quality of the bio-engineered bone graft product, which accounted for more than one-fifth of the company’s revenue in 2011.

Those allegedly false statements came in the form of clinical studies and reports published in medical journals, which the lawsuit claims were either secretly ghost-written or edited by Medtronic to hide evidence of serious complications and a lack of effectiveness linked to the use of Infuse.

Medtronic stock has suffered a number of big drops in value as information has surfaced about the potential side effects of the Infuse bone graft product.

Studies Raise Questions About Medtronic Infuse

The complaint comes shortly after two studies were published in the Annals of Internal Medicine suggesting that Medtronic Infuse provides no benefits over traditional spine surgery and may expose users to certain risks. The reports involved independent re-evaluations of data from all clinical trials conducted involving Medtronic Infuse, after it was discovered that Medtronic influenced prior studies to hide complication rates and potential side effects.

Medtronic released all patient-level data for independent review after facing substantial criticism and investigations over the off-label promotion of Infuse.

In 2012, the U.S. Senate Finance Committee released a report detailing the findings of a congressional investigation into whether Medtronic had manipulated previous medical studies that appeared to downplay Infuse risks and overstate its effectiveness.

Congressional investigators found that Medtronic paid out $210 million to authors of studies sponsored by the company. Those studies appeared to have purposefully left out findings that suggested Infuse could increase the risk of male sterility, bone growth problems, cancer, and back and leg pain.

The 16-month investigation found that Medtronic employees edited and even wrote parts of some of the studies before they were published. However, the studies did not disclose Medtronic employee involvement.

Medtronic Infuse Complications

Medtronic Infuse is a bone morphogenetic protein (BMP) that is designed to be applied to an absorbable collagen sponge placed within a device known as an LT-Cage, which is then implanted to encourage bone growth and fuse the gaps between vertebrae. It is marketed as an alternative to traditional spinal surgery, where bone is harvested from another part of the body or a cadaver, to encourage fusion of the vertebrae.

Although the device was only approved for the limited spinal surgeries involving a single-level anterior lumbar interbody fusion (ALIF), where the spine is approved from the front, the Medtronic Infuse has been widely used “off-label” for other types of spine fusion surgery, which have been linked to an increased risk of severe and painful complications caused by excessive or ectopic bone growth. Some estimates suggest that off-label use of the product account for 85% to 90% of all Infuse spine fusion surgeries.

The company faces a mounting number of Medtronic Infuse injury lawsuits brought by individuals who experienced serious and debilitating problems following off-label use of the device, raising similar allegations to those brought in this latest investor class action.