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Motion to Dismiss Medtronic INFUSE Bone Graft Lawsuit Denied

A motion to dismiss a Medtronic INFUSE bone graft lawsuit has been denied by an Illinois state judge. The judge presiding over the motion, Judge Eileen M. Brewer of Cook County Circuit Court, denied it based on the fact that state law claims parallel federal law in this case.

In addition, Judge Brewer ruled that medical device manufacturers are not entitled to liability protection if the manufacturer’s failure to follow federal law results in injury to a patient. In this case, the INFUSE bone graft injury occurred after the device was used in a procedure fusing vertebrae in the cervical spine. The device was not approved for this specific use by the FDA.

Original complaint alleges serious INFUSE bone graft injury

The original complaint in question was filed in the Circuit Court by Karl Sanda, who underwent cervical spine surgery on January 10, 2011. The procedure was done to fuse cervical vertebrae with the sacrum, using the INFUSE bone graft manufactured by Medtronic. The device was used in an off-label manner, based on promotion of such use by company sales representatives who paid key opinion leaders, according to the plaintiff.

This is not the first Medtronic INFUSE bone graft lawsuit filed against the company after off-label use. In July, 2008, the FDA sent out a safety notification warning surgeons against using this device for surgeries in the cervical spine. The notification stated the agency had received at least 38 reports of complications associated with the use of these types of devices in cervical spine fusion.

One of the complications listed in the FDA safety notification was the need for a second surgery to drain the surgical site. Sanda claims that after his initial procedure, he required a second emergency surgery soon after to eliminate a massive seroma. A seroma is a pocket of fluid that can develop after some surgical procedures. A seroma must be drained, and the complication can make recovery more difficult for the patient.

In Sanda’s case, the subsequent emergency procedure successfully eliminated the seroma. However, Sanda suffered partial paralysis, permanent disability and persistent pain as a result. Sanda is now demanding compensation for his INFUSE bone graft problems and injuries from Medtronic.

No preemption in case, judge determines

Medtronic filed a motion to dismiss this lawsuit based on the assumption that the plaintiff’s claims are federally preempted by the Food, Drug and Cosmetic Act. However, Judge Brewer ruled that the claims are not preempted, since the off-label use violated FDA regulations for the device. State duties for a violation of FDA regulations parallel federal requirements, rather than adding to them, according to Judge Brewer’s decision.

The Medtronic INFUSE bone graft was first approved by the FDA for use in the U.S. in 2002. However, since the device went on the market, serious complications have been reported by numerous patients. Studies recently published in the Annals of Internal Medicine have also indicated that the bone graft works no better than traditional surgical procedures, and may carry an increased risk of injury and cancer.

Since the FDA released its safety notification in 2008, the agency has received hundreds of reports of serious complications associated with the Medtronic device. It is now estimated that at least 100 injured patients have filed a Medtronic INFUSE bone graft lawsuit. Plaintiffs allege the manufacturer produced a defective medical device and failed to warn consumers and the medical community about potential complications, while fraudulently marketing its benefits.