Infuse Lawsuit May Go to a Jury

So far, U.S. Supreme Court “Preemption” decisions have kept Medtronic, Inc. from having to go to a jury to defend itself in several Infuse lawsuits.

But that may be about to change as a state judge in Minnesota has ruled that the company can be sued in state court on charges that it manipulated research and misled surgeons about the dangers of off-label uses of Infuse.

The judge had previously refused to let a case of a patient who claims he was injured by the product proceed because of the Supreme Court rulings that usually exclude people injured by federally approved medical devices from suing the manufacturer. But after additional analysis of more detailed allegations filed after the initial decision, Judge Laurie Miller is allowing the case to proceed for three allegations.

Medtronic has been able to avoid trials in a number of cases by convincing judges that the Supreme Court rulings prohibit patients from suing in state courts for malfunctions of FDA approved devices. But judges in several state courts and at least two federal courts have reportedly recently let cases go forward. Another Supreme Court showdown could be down the road if the parties choose to litigate that far.

A jury may eventually decide whether Medtronic downplayed the dangers of Infuse in convincing surgeons to use the product in off-label ways. Off-label uses reportedly produced roughly 90% of the $800 million in revenue Medtronic made from Infuse in 2011.

The patient’s lawyers will be able to interview surgeons involved in the research and development of the product. Medtronic employees who engaged those surgeons in publishing research and presenting clinical evidence to the FDA will also be subject to interrogation.

According to published reports, Medtronic will have one more chance to prevent a trial by arguing that the information revealed in the interviews does not prove fraud.

Medtronic called Miller’s ruling “an early procedural decision in one case and does not change the Court’s prior ruling dismissing as pre-empted all claims other than alleged fraud.”

The company also reportedly said Miller did not address other defenses claimed by the company.

Medtronic stated that it will continue to stand behind Infuse bone graft and vigorously defend it in court.

According to Minnesota Star Tribune reports, Miller ruled that a jury could decide if the doctors Medtronic paid were agents of the company. If so, that would link Medtronic to seminars and other teaching episodes that promoted the off-label use of Infuse.

Miller also noted that one of the doctors for the plaintiff is prepared to testify that Medtronic-affiliated physicians misrepresented to him the safety of using Infuse in non-FDA-approved ways. Miller rejected Medtronic’s claim that it could not be sued because company representatives never spoke directly to the plaintiff about off-label use of Infuse and the plaintiff produced no evidence that they did.

No dates have been reported of final decision about allowing the case to proceed to a jury.