Medtronic Sued over INFUSE Bone Graft

Category : Uncategorized on May 9, 2013

88 patients have filed a lawsuit in a United States federal court against Medtronic, Inc. – the manufacturer of INFUSE Bone Graft. They are also suing a spinal surgeon for allegedly performing experimental spine operation without consent, a recent report says.

In their lawsuit, former patients allege that Doctor Abubakar A Durrani carried out experimental, medically unnecessary spine surgeries. Durrani conducted these surgeries using improperly and falsely marketed medical equipment and drugs manufactured by Medtronic, according to the suit. The claimants filed their complaint in the U.S. District Court for the Southern District of Ohio.

The suit states that Durrani received kickbacks from the company (Medtonic) for selling INFUSE Bone Graft. The complaint also states Medtronic marketed INFUSE improperly. Additionally, the company influenced the research regarding the efficacy and safety of INFUSE prior to and following its release into the stream of commerce, the complaint says.

INFUSE is an artificial bone morphogenetic protein (BMP-2), which generally injected into spine at the time of surgery. It helps the damaged bone grow again.

A lot more people are expected to take legal proceedings against Medtronic Inc., the lawsuit says.

3 of the 88 patients are minors. In addition to Durrani and Medtonic, they are also suing Advanced Spine Technologies, W. Chester Medical Centre, UC Health, Children’s Medical Centre PSC, and Medtronic Sofamor Danek.

Most of the claimants say they suffered unrelieved pain because of the unwanted surgery performed by Durrani. The plaintiffs’ lawyer has filed fifteen additional complaints this year against Dr. Durrani and the CAST (Centre for Advanced Spine Technologies).

Durrani is a CAST member and he has business relationship the BMP-2 maker Medtronic, the complaint states.

“The Food and Drug Administration (FDA), physicians, and independent researchers say INFUSE has been linked casually with cancer, ectopic bone growth, spinal stenosis, retrograde ejaculation, pain, throat & breathing constriction and swelling, in addition to several other complications,” the plaintiffs allege.

“During the needless spine operations, Dr. Durrani implanted hardware such as thoracic and cervical rods, cages and screws into the patients. He used the drug known as BMP-2 or INFUSE, which is made marketed, distributed and sold by the defendant company (Medtronic Inc). The FDA has not approved BMP-2 for using on the thoracic and cervical spine. INFUSE is not at all safe, neither it has been approved, for children aged under 21 years,” the plaintiffs’ attorney said.

A spokesperson representing the company said all the allegations against Medtronic are baseless.

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