Medtronic Infuse Lawsuit Muddle

Los Angeles, CAShortly after a California man filed a Medtronic Infuse Bone Graft lawsuit against Medtronic Inc., the manufacturer, a motion to dismiss the Medtronic Infuse lawsuit was denied by an Illinois state judge on the grounds that it was used off-label. But just this week, a Minneapolis judge ruled that federal law will not allow Minnesota courts to hear the cases of dozens of people who say they were injured by Medtronic Inc.’s Infuse spinal device.

On August 9, 2013, the motion to dismiss, which was granted by Judge Laurie Miller, was based partly on recent US Supreme Court rulings that found medical device makers could not be sued by patients if the US Food and Drug Administration (FDA) had already approved their products. This ruling came in the wake of a lower court judge in Cook County, Illinois, who allowed a Medtronic Infuse lawsuit to go forward a few weeks ago. That lawsuit alleged that Medtronic promoted unapproved uses of its Infuse Bone Graft product and it also alleged faulty labeling. These claims were similar to those brought in Minnesota.

These latest decisions leave thousands of Medtronic Infuse patients nationwide with potential injury claims in a quandary. On the one hand, doctors can use the Medtronic device off-label, according to Judge Miller. But on the other hand, experts say that it is illegal for Medtronic to promote the Infuse as an off-label alternative.

To make matters even more muddled, Judge Eileen M. Brewer of Cook County Circuit Court denied a motion to dismiss a Medtronic Infuse bone graft lawsuit based on the fact that state law claims parallel federal law in this case. Furthermore, Judge Brewer ruled that the makers of medical devices such as Medtronic are not entitled to liability protection if the manufacturer’s failure to follow federal law results in injury to a patient.

In this Medtronic case, the Infuse bone graft injury occurred after the device was used in a procedure that fused vertebrae in the cervical spine - a procedure that was used off-label. The lawsuit was filed after the plaintiff, Karl Sanda, underwent cervical spinal surgery in January 2011. The suit alleges that the Infuse bone graft was used off-label, based on promotion by Medtronic sales representatives who paid key opinion leaders.

Based on the assumption that the plaintiff’s claims are federally preempted by the Food, Drug and Cosmetic Act, Medtronic filed a motion to dismiss the lawsuit. Judge Brewer, however, ruled that the claims are not preempted, since the off-label use violated FDA regulations for the device.

Meanwhile, the California man’s lawsuit includes allegations of products liability, and he is seeking an unspecified amount of compensatory and punitive damages.