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-Appellees).
First District, Third Division Docket No. 1-16-2928
Illinois Official Reports Appellate Court
September 20, 2017
2017 IL App (1st) 162928
Decision Under Review: Appeal from the Circuit Court of Cook County, No. 15-L-011806; the Hon. John P. Callahan, Judge, presiding. Judgment: Reversed and remanded.
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.
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.
I. BACKGROUND
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.
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.
¶ 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) (
¶ 10 Medtronic initially moved to dismiss the complaint as inadequately pled under
¶ 11 On August 16, 2016, Medtronic filed a motion to dismiss pursuant to
II. ANALYSIS
A. Standard of Review
¶ 14 Plaintiffs’ complaint was dismissed under
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
¶ 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.”
¶ 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 (2008). However, in the 1970s, Congress amended the FDCA, creating “a regime of detailed federal oversight” over medical devices. Id. at 316; see also Medical Device Amendments of 1976, Pub. L. No. 94-295, § 2, 90 Stat. 539, 540 (1976) (adding
¶ 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 device under this chapter.”
21 U.S.C. § 360k(a) (2012).
Also relevant to our review is section 337(a) of the FDCA (
¶ 21 The Supreme Court later elaborated on Lohr‘s holding in Riegel. In that case, the Court considered whether plaintiff‘s state-law claims against the manufacturer of a Class III, premarket-approved balloon catheter were preempted under section 360k(a). Riegel, 552 U.S. at 330. In considering the section, it established a two-step process for analyzing preemption claims: (1) a determination whether the federal government had established requirements applicable to the device and, if so, (2) whether a plaintiff‘s claims are based on requirements imposed by the state are different from, or in addition to, the federal requirements related to safety and effectiveness. See id. at 321-22; see also Raleigh, 403 Ill. App. 3d at 873. The Court explained that the premarket approval process imposed federal “requirements,” triggering the preemption clause of section 360k(a), and that the tort duties underlying common-law claims would also constitute “requirements” under the section. Riegel, 552 U.S. at 322-25. Ultimately, it concluded that the state tort law underlying the plaintiffs’ claims would require a manufacturer‘s device to be safer than the model device approved by the FDA, and therefore those requirements were preempted. Id. at 330 However, the Court explained that preemption only applies to devices that “violated state tort law notwithstanding compliance with the relevant federal requirements.” Id. It further noted “§ 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.” Id. (quoting Lohr, 518 U.S. at 495).
¶ 22 Finally, our analysis is also informed by the Supreme Court‘s discussion of implied preemption under the FDCA in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). There, the Court addressed section 337(a) of the FDCA, in which it found “clear evidence that Congress intended that the [amendments to the FDCA] be enforced exclusively by the Federal Government.” Id. at 352. Therefore, it held, section 337(a) preempts any state tort claim that exists “solely by virtue” of an FDCA violation. Id. at 353. At the same time, the Court left undisturbed the portion of Lohr allowing state lawsuits based on state common-law torts that “predate[ ]” the FDCA but “parallel” its regulations. Id.
¶ 23 Plaintiffs’ complaint asserts that the Infuse is a Class III medical device that has gained premarket approval from the FDA. It is clear, under the Supreme Court‘s guidance, that the device is therefore subject to federal requirements. The question that remains is whether plaintiffs’ state-law claims involve requirements that are impermissibly different from, or in addition to, the federal requirements or permissibly parallel to the federal regulations. Moreover, under Buckman, any parallel state-law requirements must not exist solely as a remedy for the federal violation. Our research has revealed no Illinois case addressing the issue of parallel requirements. Because our decision requires the interpretation of federal law, we look to the federal circuit courts of appeals for guidance. See State Bank of Cherry v. CGB Enterprises, Inc., 2013 IL 113836, ¶ 33.
¶ 25 The Ninth Circuit Court of Appeals, in Stengel v. Medtronic, Inc., 704 F.3d 1224, 1227 (9th Cir. 2013), examined allegations that a manufacturer had allegedly learned about certain risks of its device after it had received premarket approval but failed to notify the FDA before the plaintiff suffered harm. The plaintiff brought a state-law negligence claim against the manufacturer for failing to disclose the newly discovered risks to the FDA in violation of duties established by federal and state law. Id. at 1226. The Ninth Circuit held that the plaintiff‘s failure to warn claim under Arizona law was parallel to the federal regulations requiring notifying the FDA because Arizona law “has long been concerned with the protection of consumers from harm caused by manufacturers’ unreasonable behavior. Plaintiffs’ claim is brought under settled Arizona law that protects the safety and health of Arizona citizens by imposing a general duty of reasonable care on product manufacturers,” including by requiring manufacturers to disclose risks discovered after sale. Id. at 1233. Thus, it held that the claim was not preempted. Id.
¶ 26 The Tenth Circuit addressed the issue in Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1336 (10th Cir. 2015). There, the plaintiff raised, inter alia, allegations substantially similar to plaintiffs’ here. See id. at 1337-38. The court first noted that all of the plaintiff‘s claims for which she had not identified a parallel federal regulation were clearly preempted. Id. at 1340-41. It went on to address the plaintiff‘s claims for failure to warn, negligence, and negligent misrepresentation, which plaintiff argued were parallel to regulations found in
“[T]hat usually means it isn‘t possible to prepare adequate directions for its safe use by laymen. [
21 C.F.R.] § 801.109 . And for precisely this reason,21 C.F.R. § 801.109 generally absolves manufacturers from liability under§ 352 and§ 801.5 so long as they label their prescription devices in a certain manner approved by the FDA.” Id.
¶ 27 Having reviewed the federal case law, it is clear that plaintiffs’ claims are preempted to the extent that they are not premised entirely on an identified parallel federal regulation. Plaintiffs have identified two primary federal regulations which they believe are parallel to their claims: (1) a requirement to submit reports of adverse events to the FDA and (2) a prohibition against misbranding.
¶ 28 Plaintiffs argue that their claims are not preempted because, similarly to the plaintiffs in Hughes and Stengel, they allege Medtronic failed to report adverse events to the FDA as required as a condition to the Infuse‘s premarket approval. However, although plaintiffs have identified a federal requirement that their complaint alleges Medtronic violated, there is no Illinois requirement that parallels it. Plaintiffs asserted claims for failure to warn. Although Illinois recognizes that a manufacturer may satisfy its duty to warn by conveying information to third-party learned intermediaries (see Kirk v. Michael Reese Hospital & Medical Center, 117 Ill. 2d 507, 519 (1987)), this is not synonymous with an affirmative duty to warn a federal regulatory body. The learned intermediary doctrine states that a manufacturer has a duty “to warn prescribing physicians of a drug‘s known dangerous propensities” under the understanding that those physicians will use their expert knowledge in adequately warning the patient. Martin v. Ortho Pharmaceutical Corp., 169 Ill. 2d 234, 238 (1996). We cannot find that this duty is parallel to the federal requirement. Although the federal appellate courts found differently in Hughes and Stengel, those opinions were based upon duties found under Mississippi and Arizona law, respectively, and are therefore distinguishable.
¶ 29 Plaintiffs also argue that their claims parallel federal regulations against misbranding through
“in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article.”
21 U.S.C. § 321(n) (2012).
Thus, it is clear that misbranding may occur under federal requirements, where advertising is misleading due to a failure to reveal pertinent facts regarding the risks or consequences of the device in question‘s usage.
¶ 30 In order to establish a strict-liability failure to warn claim under Illinois law, a plaintiff must prove that the manufacturer did not disclose an unreasonably dangerous condition or instruct on the proper use of the product as to which the average consumer would not be aware. Salerno v. Innovative Surveillance Technology, Inc., 402 Ill. App. 3d 490, 499 (2010). The duty to warn arises where the product possesses dangerous tendencies, the manufacturer knows of the nonobvious risks of harm, and knows or should know that harm may occur without instruction or a warning. Id. Similarly, in order to prove a negligent failure to warn
¶ 31 Plaintiffs’ complaint asserts claims for failure to warn based on its allegations that Medtronic produced and disseminated advertising which was “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 insofar as they parallel the federal prohibition against misbranding.
¶ 32 Medtronic argues that the claims are preempted because plaintiffs are attacking the sufficiency of the FDA-approved label or categorically attacking the promotion of off-label uses. This misconstrues plaintiffs’ complaints. Plaintiffs do not attack the sufficiency of the Infuse‘s labeling but rather the allegedly deceptive marketing practices of Medtronic after approval was given. We note that unlike the label, the promotion of the device was not pre-approved by the FDA. Medtronic also argues that the claim must be preempted because, it asserts, the only possible way to provide additional warning would be through changing the labeling, an action that cannot be made without further FDA approval. This argument is unpersuasive. The regulations promulgated by the FDA clearly indicate that labeling and advertising are separate actions. See, e.g.,
¶ 33 We briefly acknowledge that plaintiffs also argued that their claims paralleled
C. Adequacy of the Pleadings
¶ 35 Medtronic argues, in the alternative, that the trial court erroneously denied its petition to dismiss plaintiffs’ complaint under
¶ 37 A section 2-615 motion to dismiss presents the question of whether the facts alleged in the complaint, viewed in the light most favorable to the plaintiff, are sufficient to entitle the plaintiff to relief as a matter of law. Chandler v. Illinois Central R.R. Co., 207 Ill. 2d 331, 348 (2003). When reviewing such a dismissal, we presume that the motion admits all well-pleaded facts and all reasonable inferences from those facts. Napleton v. Village of Hinsdale, 229 Ill. 2d 296, 320 (2008). A cause of action should be dismissed only when it is clearly apparent that no set of facts can be proved that will entitle a plaintiff to recovery. Id. at 305. Our supreme court has repeatedly stated “that Illinois is a fact-pleading jurisdiction.” Marshall v. Burger King Corp., 222 Ill. 2d 422, 429 (2006). As such, notice to the defendants is not enough; instead, the plaintiff must allege facts “sufficient to bring a claim within a legally recognized cause of action [citation], not simply conclusions.” See id. at 429-30. Because such a determination raises issues of law, we review orders granting section 2-615 dismissals de novo. Heastie v. Roberts, 226 Ill. 2d 515, 530-31 (2007).
¶ 38 As we previously stated, to assert claims under both negligent and strict-liability theories, plaintiffs were required to plead facts alleging that Medtronic failed to instruct or warn of a danger of the product and that failure proximately caused the plaintiff‘s injuries. See Salerno, 402 Ill. App. 3d at 499; Solis, 2012 IL App (1st) 110875, ¶ 56. Under the learned intermediary doctrine, Medtronic was only required to provide sufficient warnings to Norabuena‘s surgeon. See Martin, 169 Ill. 2d at 238. After reviewing the complaint, we find that plaintiffs allege numerous instances of promotion where Medtronic allegedly withheld or omitted information regarding adverse events and risks associated with off-label use of the Infuse. However, there are no specific factual allegations in the complaint asserting that Norabuena‘s surgeon encountered or relied on any of the asserted promotional marketing. Each count instead sets forth the conclusory statement that Norabuena‘s injuries were caused “as a direct and proximate result” of one or more of Medtronic‘s actions or omissions. Bare legal conclusions are insufficient to state a legal claim (Marshall, 222 Ill. 2d at 430), and therefore we must find that the complaint failed to sufficiently allege facts indicating that Medtronic‘s actions or
¶ 39 Accordingly, we hold that the dismissal of plaintiffs’ complaint was proper. However, as we rely on different reasoning than the trial court, we must further address the issue of whether that dismissal should have been made with prejudice. A dismissal under section 2-615 of the Code should be made with prejudice only where it is clearly apparent that the plaintiffs can prove no set of facts entitling recovery. Illinois Graphics Co. v. Nickum, 159 Ill. 2d 469, 488 (1994). The trial court has discretion to deny leave to amend a complaint, but “the trial court should exercise its discretion liberally in favor of allowing amendments if doing so will further the ends of justice, and it should resolve any doubts in favor of allowing amendments.” In re Application of the County Collector, 343 Ill. App. 3d 363, 370 (2003). A court should typically “give a plaintiff at least one opportunity to cure the defects in his or her complaint.” Id. As the trial court did not dismiss the complaint for insufficient pleadings, it did not consider whether plaintiffs should have the opportunity to amend their complaint. We find that although the pleadings are insufficient, it is not clearly apparent that plaintiffs can prove no set of facts entitling recovery. Accordingly, the dismissal should be without prejudice, and plaintiffs should be given the opportunity to amend their complaint.
III. CONCLUSION
¶ 41 For the foregoing reasons, we hold that plaintiffs’ failure to warn claims are not expressly or impliedly preempted insofar as they assert claims that Medtronic misbranded its Infuse by omitting material information regarding risks of off-label uses. However, we hold that the complaint failed to sufficiently plead that Norabuena‘s injuries were proximately caused by Medtronic‘s actions or omissions, and thus dismissal without prejudice was warranted. Accordingly, we reverse the judgment of the circuit court of Cook County dismissing plaintiffs’ complaint with prejudice and remand this cause to the circuit court of Cook County for further proceedings consistent with this opinion.
¶ 42 Reversed and remanded.