Plaintiffs won an important preemption battle in U.S. District Court in Ariz. August 2013 when Judge G. Murray Snow ruled that Medtronic changed the calculus of preemption by breaking federal law in promoting off-label use of Infuse. Consequently, the judge ruled, the company was no longer able to claim immunity by federal preemption.
The court wrote: “In short, the FDA strictly regulates manufacturers based on the intended use of the device, and manufacturers can deviate from those specifications only with permission.”
Lawyers for Medtronic, Inc., had claimed that federal law preempts state law in this case; they argued that because Infuse had been approved by the FDA (in 2003), it was then shielded from liability if it injured anyone. Though shot down in Arizona, that argument appeared to work a week earlier in a court in Minnesota, where Medtronic maintains headquarters.
Minnesota Ruling Differs
In Minneapolis, Judge Laurie Miller ruled in August that federal law will not allow Minn. courts to hear the cases of dozens of people injured by Medtronic Inc.’s Infuse spinal device. Judge Miller granted the motion to dismiss based partly on recent U.S. Supreme Court rulings that found medical device makers could not be sued by patients if the FDA had already approved their products.
This decision was controversial, to say the least. Nevertheless, Judge Miller did leave the legal door open for plaintiffs to re-plead the cases under different causes of action; so there is still some hope left for these Infuse-injured people whose cases were filed in Minnesota.
Cook County Ruling also for Plaintiffs
Plaintiffs also won an import decision in July 2013 when a lower court judge in Illinois ruled that a Medtronic Infuse lawsuit can go forward despite defense arguments that the lawsuit is preempted by federal law. The lawsuit alleges that Medtronic promoted unapproved uses of Infuse Bone Graft and it also alleges faulty labeling.
Eperts say it is illegal for Medtronic to promote Infuse off-label (though it is not illegal for doctors to use a product off label), and Judge Eileen M. Brewer agreed. In Cook County Circuit Court, Judge Brewer denied a defense motion to dismiss a Medtronic Infuse bone graft lawsuit based on the fact that state law claims parallel federal law in this case. Furthermore, the judge ruled that makers of medical devices are not entitled to liability protection if the manufacturer’s failure to follow federal law results in patient injury.
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, because the off-label use and the promotion of that off-label use violated FDA regulations for the device.
In this case, the Infuse bone graft injury occurred after a procedure that fused vertebrae in the cervical spine. The lawsuit was filed after plaintiff, Karl Sanda underwent cervical spinal surgery in Jan. 2011. The suit alleges the Infuse bone graft was used off-label based on promotion by Medtronic sales representatives who paid key opinion leaders to promote the off label usage.