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Goldstein Bender & Romanoff Secure Appellate Victory Against Medtronic in Infuse™ Litigation

On September 20, 2017, the Illinois Appellate Court for the First District released its opinion in Senayda Norabuena and Miguel Torres v. Medtronic, Inc., 2017 IL App (1st) 162928*, reversing the trial court’s prior dismissal of Norabuena and Torres’ products liability claims.  Partner Ryan M. Griffin and Associate Scott M. Duxbury successfully argued that the plaintiffs’ claims were parallel to federal regulations against misbranding. Mr. Griffin and Mr. Duxbury believe that this is a landmark decision regarding a device manufacturer’s marketing communications.

The case involves the Infuse Bone Graft/LT-Cage Lumbar tapered Fusion device (“Infuse”) manufactured by Medtronic – one of the world’s largest medical device companies – to stimulate bone fusion following spinal surgeries. The federal Food and Drug Administration of the United States Department of Health and Human Services approved Infuse in 2002 as a Class III medical device for implantation via an anterior surgical approach, with use of all of Infuse’s component parts, and at specific vertebral levels. Norabuena and Torres’ attorneys at Goldstein Bender & Romanoff alleged that Medtronic made false, misleading and deceptive statements when marketing Infuse for other uses than those approved by the FDA.  Norabuena and Torres contend that these statements were defective warnings under Illinois law that paralleled genuinely equivalent federal regulations prohibiting false and misleading advertising.

Medtronic attempted to defeat Norabuena and Torres’ claims by raising the defenses of express and implied preemption.  Specifically, Medtronic argued that the claims were expressly barred by section 360(k)(a) of the Food, Drug and Cosmetic Act. Medtronic also argued Norabuena and Torres’ claims were impliedly preempted pursuant to 21 U.S.C. § 337(a) (2012) because Illinois did not recognize a products liability claim involving “off-label” promotional communications.

Mr. Griffin and Mr. Duxbury argued on appeal that the United States Supreme Court decisions in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), allowed injured individuals to proceed on a products liability lawsuit in state court.  The Illinois Appellate Court agreed: Plaintiffs’ complaint asserts claims for failure to warn based on its allegations that Medtronic produced and disseminated advertising which as “false, misleading, and deceptive” in that it “concealed known dangerous side effects regarding off-label uses.” In other words, Medtronic’s advertising was misleading because it failed to reveal material facts regarding the consequences of using the Infuse in the manner suggested by the advertising. Thus, in the manner pled by plaintiffs, the failure to warn claims parallel the federal requirements regarding misbranding: both prohibit the omission of material risks of the device when marketing a product.  As such, plaintiffs’ claims are neither expressly nor impliedly preempted in so far as they parallel the federal prohibition against misbranding. 2017 IL App (1st) 162928, ¶ 31.

Thousands of injured individuals have taken legal action against Medtronic after suffering adverse consequences from unapproved uses of Infuse, and Medtronic has steadfastly defended these claims on the basis that they are preempted. The attorneys at Goldstein Bender & Romanoff are pleased to have vindicated the rights of their clients in this appeal, and look forward to the ongoing fight for justice as the case continues.


— Scott M. Duxbury