Norabuena v. Medtronic, Inc.

2017 IL App (1st) 162928

86 N.E.3d 1198

Senayda NORABUENA and Miguel Torres, Plaintiffs-Appellants,

v.MEDTRONIC, INC., Medtronic Sofamor Danek USA, Inc., and Northwestern Memorial Healthcare, Defendants.

(Medtronic, Inc., and Medtronic Sofamor Danek USA, Inc., Defendants-Appellants.)

No. 1-16-2928

Appellate Court of Illinois, First District, Third Division.

Opinion filed September 20, 2017

Ryan M. Griffin and Scott M. Duxbury, of Goldstein, Bender & Romanoff, of Chicago, for appellants.

Daniel L. Ring and Laura Babinsky, of Mayer Brown LLP, of Chicago, and Andrew E. Tauber (pro hac vice) and John T. Lewis (pro hac vice), of Mayer Brown LLP, of Washington, D.C., for appellees.

PRESIDING JUSTICE COBBS delivered the judgment of the court, with 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 Healthcare¹ 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. Standard of Review

¶ 14 Plaintiffs' complaint was dismissed under section 2-619(a)(9) of the Code. A section 2-619 motion admits the legal sufficiency of the complaint but argues that some defense or affirmative matter defeats the claim. Ball v. County of Cook, 385 Ill. App. 3d 103, 107, 324 Ill.Dec. 548, 896 N.E.2d 334 (2008). The defendant bears the burden of proving such an affirmative defense exists. Daniels v. Union Pacific R.R. Co., 388 Ill. App. 3d 850, 855, 328 Ill.Dec. 493, 904 N.E.2d 1003 (2009). We review the trial court's dismissal of a complaint under section 2-619de novo. Evanston Insurance Co. v. Riseborough, 2014 IL 114271, ¶ 13, 378 Ill.Dec. 778, 5 N.E.3d 158. Further, we may affirm a dismissal on any basis apparent from the record. In re Detention of Duke, 2013 IL App (1st) 121722, ¶ 11, 377 Ill.Dec. 916, 2 N.E.3d 1197.

¶ 15 B. Preemption

¶ 16 Plaintiffs contend that the trial court erred in finding that their claims were expressly preempted by section 360k(a) and impliedly preempted by section 337(a) because their complaint asserted state-law tort claims that are parallel to federal regulations. They argue that the claims are parallel to federal regulations that (1) prohibit false and misleading statements, (2) prohibit promotional materials without adequate warnings, and (3) require the submission of adverse event reports. Medtronic responds that the plaintiffs' claims would impermissibly impose state-law requirements that are different from and additional to federal requirements.

¶ 17 The supremacy clause of article VI of the United States Constitution provides that the laws of the United States "shall be the supreme Law of the Land; *** any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const., art. VI, cl. 2. Thus, preemption doctrine requires that any state law is null and void if it conflicts with federal law. Carter v. SSC Odin Operating Co., 237 Ill. 2d 30, 39, 340 Ill.Dec. 196, 927 N.E.2d 1207 (2010). Federal law preempts state law in three different circumstances: "(1) express preemption—where Congress has expressly preempted state action; (2) implied field preemption—where Congress has implemented a comprehensive regulatory scheme in an area, thus removing the entire field from the state realm; or (3) implied conflict preemption—where state action actually conflicts with federal law." Id. at 39-40, 340 Ill.Dec. 196, 927 N.E.2d 1207. The question of preemption, therefore, rests primarily upon Congress's intent. City of Chicago v. Comcast Cable Holdings, L.L.C., 231 Ill. 2d 399, 405, 326 Ill.Dec. 620, 900 N.E.2d 256 (2008).

¶ 18 The FDA was initially responsible for the regulation of new medical drugs while the regulation of medical devices was left primarily to the states. See Riegel v. Medtronic, Inc., 552 U.S. 312, 315, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). However, in the 1970s, Congress amended the FDCA, creating "a regime of detailed federal oversight" over medical devices. Id. at 316, 128 S.Ct. 999 ; see also Medical Device Amendments of 1976, Pub. L. No. 94-295, § 2, 90 Stat. 539, 540 (1976) (adding 21 U.S.C. § 360c ). The new regulatory scheme divided medical devices into different classes based upon their associated risks. Riegel, 552 U.S. at 316, 128 S.Ct. 999. Class III devices, like the Infuse, receive the most strenuous federal oversight. Raleigh v. Alcon Laboratories, Inc., 403 Ill. App. 3d 863, 872, 343 Ill.Dec. 206, 934 N.E.2d 530 (2010). For such devices, the FDA grants premarket approval only after a rigorous review, typically including a multivolume application with complete reports of the studies and investigations of a device's safety and effectiveness; a list of the device's elements, ingredients, and workings; descriptions of its production, processing, and packing; samples or components required by the FDA; and a sampling of the planned labeling. Riegel, 552 U.S. at 317-18, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(c)(1) (2006) ). After the FDA grants approval, a manufacturer is forbidden from "mak[ing], without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness." Id. at 319, 128 S.Ct. 999.

¶ 19 Section 360k(a) of the FDCA provides an express preemption clause, which states: "Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the

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