The Medical Device Amendment’s pre-emption clause continues to provide legal cover for medtech companies in the U.S., with Abbott getting a payer’s lawsuit dismissed over the past week.
Abbott faced a purported class-action lawsuit that a third-party payer — the ASEA/AFSCME Local 52 Health Benefits Trust in Alaska — filed last year in federal court in Minnesota. The ASEA/AFSCME Local 52 Health Benefits Trust claimed that it and other third-party payers had to needlessly spend hundreds of millions of dollars because of the way that St. Jude Medical, now part of Abbott, handled a cardiac rhythm management device batteries recall.
U.S. District Judge David S. Doty, however, dismissed the case in an order dated Jan. 24.
Doty wrote that the lawsuit was similar to previously dismissed cases where judges found that the pre-emption clause of the Medical Device Amendment mostly bars lawsuits challenging the safety and effectiveness of medical devices with FDA pre-market approvals. Past cases including Medtronic Sprint Fidelis leads product liability litigation, Kinetic v. Medtronic, and Pinsonneault v. St. Jude Medical generally held that FDA should handle such safety and effectiveness claims, not the courts.
“Indeed, the allegations here are nearly identical to those raised in the above cases, particularly Kinetic,” Doty said in his order. “Thus, under Sprint Fidelis, Kinetic, and Pinsonneault, the court is constrained to conclude that plaintiff’s claims are preempted. As a result, the court must dismiss the case.”
“Because the claims are preempted, the court will not address whether the complaint is adequately pleaded,” Doty added.
Doty’s dismissal of the case comes about half a year after the U.S. District Court for Northern Illinois dismissed a similar lawsuit from the ASEA/AFSCME Local 52 Health Benefits Trust against Abbott, saying that it lacked jurisdiction. The health benefits trust then filed against Abbott in Minnesota, where St. Jude Medical is based.