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Norabuena v. Medtronic, Inc.

Court of Appeals of Illinois, First District, Third Division

September 20, 2017

MEDTRONIC, INC., MEDTRONIC SOFAMOR DANEK USA, INC., and NORTHWESTERN MEMORIAL HEALTHCARE, Defendants. (Medtronic, Inc., and Medtronic Sofamor Danek USA, Inc., Defendants-Appellants.)

         Appeal from the Circuit Court of Cook County.No. 15 L 011806 Honorable John P. Callahan, Judge, presiding.

          Fitzgerald Smith and Lavin Justices concurred in the judgment and opinion.



         ¶ 1 Plaintiffs Senayda Norabuena and Miguel Torres appeal from the trial court's dismissal of their complaint asserting strict liability and negligence claims for failure to warn as well as loss of consortium claims against defendants Medtronic, Inc., and Medtronic Sofamor Danek USA, Inc., (collectively "Medtronic"). They contend that the trial court erroneously found that their claims were both expressly and impliedly preempted by federal law. Medtronic responds that the claims were properly dismissed as preempted and, alternatively, that the complaint was insufficiently pled. We hold that the claims are not preempted but the complaint failed to adequately plead that Medtronic's actions proximately caused plaintiffs' injuries. Accordingly, dismissal should have been without prejudice, and we reverse and remand.

         ¶ 2 I. BACKGROUND

         ¶ 3 A. The Device

         ¶ 4 This case centers on a prescription medical device called the Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device (Infuse), which is an implantable apparatus used in spinal fusion surgeries. The device is manufactured by Medtronic and includes two components: a titanium spinal fusion cage and a recombinant human bone morphogenetic protein paired with a collagen sponge. It is subject to regulation by the United States Food and Drug Administration (FDA) as a Class III medical device.

         ¶ 5 The FDA granted premarket approval of the Infuse on July 2, 2002. The premarket approval included an approved warning label indicating that the device was for use at one level of the spine and it should be implanted via an anterior approach. The label also warned that "ectopic or exuberant bone formation" had been observed when the Infuse was implanted via a posterior approach and the device's metal cage was not used.

         ¶ 6 B. Plaintiff's Surgery

         ¶ 7 Norabuena sought treatment for back and leg pain at Northwestern Memorial Hospital.Dr. Michael Haak diagnosed her with lumbar degenerative disc disease and left lumbar radiculopathy. On September 24, 2012, Haak performed surgery on Norabuena using the Infuse in an "off-label" manner, implanting it at multiple levels in a posterior approach without using the device's cage. Following the surgery, Norabuena continued to have pain. On November 19, 2013, a different doctor informed Norabuena that heterotopic bone had formed to the left of her spinal canal and was likely causing her pain.

         ¶ 8 C. The Complaint

         ¶ 9 Norabuena and Torres, her husband, filed a nine-count complaint against Medtronic and Northwestern Memorial Healthcare[1] on November 18, 2015. Norabuena asserted a strict liability claim for defective warnings and a negligence claim for failure to warn against each of the defendants. Torres asserted a derivative loss of consortium claim against each defendant. In the complaint, they alleged that Medtronic promoted off-label uses of the Infuse through an advertising campaign as well as royalty payments to spine surgeons for research, training, and consulting. The paid surgeons then further promoted off-label uses through medical publications, seminars, and direct consultations with other surgeons. Plaintiffs alleged that Medtronic's promotional campaign emphasized the benefits of the Infuse in off-label applications while devaluing or omitting the potential adverse effects of such uses. Medtronic also violated federal requirements outlined in the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 301 et seq. (2012)) when it "failed to adequately warn and/or apprise the FDA of known adverse side effects" of the Infuse and when it placed a "misbranded" device into commerce by failing to warn of its adverse effects.

         ¶ 10 Medtronic initially moved to dismiss the complaint as inadequately pled under section 2- 615 of the Code of Civil Procedure (Code) (735 ILCS 5/2-615 (West 2014)). The trial court denied the motion on June 10, 2016, finding that plaintiffs had sufficiently pled a cause of action "so that the defense can respond."

         ¶ 11 On August 16, 2016, Medtronic filed a motion to dismiss pursuant to section 2-619(a)(9) of the Code (735 ILCS 5/2-619(a)(9) (West 2014)), arguing that plaintiffs' claims were preempted by federal law. The trial court granted the motion and dismissed the complaint, ruling that plaintiffs' claims were expressly preempted by section 360k(a) of the FDCA (21 U.S.C. § 360k(a) (2012)) and impliedly preempted by section 337(a) (21 U.S.C. § 337(a) (2012)).

         ¶ 12 II. ANALYSIS

         ¶ 13 A. ...

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