Last week, when we reported on Medtronic’s $268 million settlement of essentially all pending U.S. claims alleging product liability defects in its Sprint Fidelis defibrillator leads, we noted that the deal came before the 8th U.S. Circuit Court of Appeals ruled on the dismissal of many of those cases on pre-emption grounds. On Friday, that ruling came down. It’s the first appellate interpretation of the U.S. Supreme Court’s ruling in Riegel v. Medtronic — and it’s a home run for fans of federal pre-emption of state law-based product liability claims. [Hat tip: Drug and Device Law blog.]
In a 12-page majority opinion, 8th Circuit Judge James Loken (writing for himself and Judge Bobby Shepherd) affirmed that the Supreme Court’s Riegel ruling leaves only a narrow crack in device manufacturers’ pre-emption defenses, permitting only state law claims that exactly parallel federal claims. And though plaintiffs counsel Daniel Gustafson of Gustafson Gluek tried to assert at oral arguments before the 8th Circuit panel last April that manufacturing defects in the defibrillator leads gave rise to parallel state claims that weren’t pre-empted by the Food and Drug Administration’s approval of the devices, the 8th Circuit found that the plaintiffs’ argument amounted to an assertion that the FDA improperly approved the design of the device — a pre-empted claim.
“As pleaded and argued, the manufacturing defect claims are not parallel, they are a frontal assault on the FDA’s decision to approve a [device] after weighing the product’s benefits against its inherent risks,” Loken wrote. “On this record, the district court properly concluded these claims are pre-empted.”
In a limited dissent, 8th Circuit Judge Michael Melloy said he would have permitted the plaintiffs limited discovery on the design defect claim, with leave to amend their master complaint based on the results of that discovery.
Kenneth Geller of Mayer Brown argued the appeal for Medtronic. He referred us to a Medtronic spokesperson. In response to our question about whether the $268 million deal might have been different if it had come after the 8th Circuit ruling, the company sent us this e-mail: “The parties entered into the settlement to avoid the uncertainties inherent in litigation and continued significant litigation risk. The parties settled the case before the Eighth Circuit issued its opinion. But as noted, the settlement avoids the uncertainties inherent in litigation. The settlement itself provides rights to both parties, including Medtronic’s ability to reject the agreement if certain conditions are not met.”
Plaintiffs’ counsel Gustafson didn’t return our call.
This article first appeared on The Am Law Litigation Daily blog on AmericanLawyer.com.