Court Opinion

ID: 4229839
Source: CourtListenerOpinion
Date Created: 2017-12-18 21:09:06.123841+00
Date Added: 2024-06-11T09:24:04.511076
License: Public Domain

Digitally signed by
                                                                           Reporter of Decisions
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                                    Appellate Court                        Date: 2017.12.11
                                                                           09:26:48 -06'00'

                  Norabuena v. Medtronic, Inc., 2017 IL App (1st) 162928

Appellate Court        SENAYDA          NORABUENA      and     MIGUEL        TORRES,
Caption                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).

District & No.         First District, Third Division
                       Docket No. 1-16-2928

Filed                  September 20, 2017

Decision Under         Appeal from the Circuit Court of Cook County, No. 15-L-011806; the
Review                 Hon. John P. Callahan, Judge, presiding.

Judgment               Reversed and remanded.

Counsel on             Ryan M. Griffin and Scott M. Duxbury, of Goldstein, Bender &
Appeal                 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.
     Panel                    PRESIDING JUSTICE COBBS delivered the judgment of the court,
                              with opinion.
                              Justices Fitzgerald Smith and Lavin concurred in the judgment and
                              opinion.

                                               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.

                                                   -2-
¶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. 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 (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 (2009). We review the trial court’s dismissal of a
       complaint under section 2-619 de novo. Evanston Insurance Co. v. Riseborough, 2014 IL
       114271, ¶ 13. Further, we may affirm a dismissal on any basis apparent from the record. In re
       Detention of Duke, 2013 IL App (1st) 121722, ¶ 11.

¶ 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

          1
           Northwestern Memorial Healthcare was not a party to Medtronic’s motion to dismiss and is not an
       appellee in the current appeal.

                                                    -3-
       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 (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. 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 (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 (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 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. Class III devices, like the Infuse, receive the
       most strenuous federal oversight. Raleigh v. Alcon Laboratories, Inc., 403 Ill. App. 3d 863,
       872 (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 (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.
¶ 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 U.S.C. § 337(a) (2012)), which
       provides that all proceedings for the enforcement of the FDCA’s provisions, barring
       exceptions irrelevant to the current proceeding, “shall be by and in the name of the United
       States.”

                                                   -4-
¶ 20       The United States Supreme Court has addressed preemption in the context of premarket
       approval on three occasions. It first significantly examined section 360k(a)’s preemption
       provision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Holding that state-law tort suits are
       not always preempted, the Court explained that tort suits that do not impose new
       “requirements” on manufacturers are not preempted so long as they only impose duties
       “parallel” to duties found in the FDCA. Id. at 495.
¶ 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.

                                                    -5-
¶ 24       Three of the federal circuit courts have addressed in opinions 2 whether common-law
       failure to warn claims, like those raised by plaintiffs, are parallel to FDA regulations. First, in
       Hughes v. Boston Scientific Corp., 631 F.3d 762, 765 (5th Cir. 2011), the plaintiff suffered
       severe burns when hot liquid leaked from a Class III medical device. She sued the device’s
       manufacturer under Mississippi law, alleging a violation of a state-law duty to warn. Id. The
       Fifth Circuit held that the plaintiff’s state-law failure to warn claim was not preempted “to the
       extent that this claim is predicated on [the manufacturer]’s failure to comply with the
       applicable federal statutes and regulations.” Id. at 764. The court stated explicitly that its
       holding extended to both express and implied preemption: “We conclude that [plaintiff]’s
       failure to warn claim is neither expressly nor impliedly preempted by the [amendments to the
       FDCA] to the extent that this claim is premised on [the manufacturer]’s violation of FDA
       regulations with respect to reporting burns caused by the [device].” Id. at 776. The court
       explained that the claims were not the type of claim barred by Buckman because Mississippi
       tort law recognized a failure to warn claim based on the failure to inform the FDA of dangers.
       See id. at 775.
¶ 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
       section 352 of the FDCA (21 U.S.C. § 352 (2012) and 21 C.F.R. § 801.5 (2012)). Caplinger,
       784 F.3d at 1341. Explaining that those regulations together required that “a device’s warning
       label must not be ‘false or misleading in any particular,’ ” the court held that most of the
       plaintiff’s general tort claims were far broader than the federal regulations, and thus
       preempted. Id. (quoting 21 U.S.C. § 352(a) (2012)). The court also noted that the Medtronic
       device at issue was a prescription device, and explained:

           2
           The Second Circuit also addressed a similar case involving the device in question in a
       nonprecedential summary order in Otis-Wisher v. Medtronic, Inc., 616 Fed. App’x 433, 434 (2d Cir.
       2015). Although the court held that the plaintiff’s failure to warn claims were preempted, the order’s
       summary nature leaves too few details to significantly guide our analysis.

                                                     -6-
                “[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 section 352(q) of the FDCA (21 U.S.C. § 352(q) (2012)). That section states that a
       device is misbranded “if (1) its advertising is false or misleading in any particular, or (2) it is
       sold, distributed, or used in violation of regulations prescribed under section 360j(e) of this
       title.” Id. Section 321(n) states that where there is an allegation of misbranding:
                “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

                                                    -7-
       claim, a plaintiff must show that the manufacturer negligently failed to instruct or warn of a
       danger of the product and that failure proximately caused the plaintiff’s injuries. See Solis v.
       BASF Corp., 2012 IL App (1st) 110875, ¶ 56.
¶ 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., 21 U.S.C. § 321(n) (2012) (describing misbranding
       when “the labeling or advertising is misleading”). Much as the FDA did not prohibit Medtronic
       from promoting the off-label uses of the Infuse (see Buckman, 531 U.S. at 350 (“Similarly,
       ‘off-label’ usage of medical devices *** is an accepted and necessary corollary of the FDA’s
       mission to regulate in this area without directly interfering with the practice of medicine.”)),
       Medtronic has pointed to no FDA regulations that prohibited it from providing additional
       warnings during that promotion.
¶ 33       We briefly acknowledge that plaintiffs also argued that their claims paralleled 21 C.F.R.
       § 801.5 (2012), which requires adequate direction be given such that a “layman can use a
       device safely and for the purposes for which it is intended.” However, as the Tenth Circuit
       noted in Caplinger, a prescription device cannot typically be explained in instructions easily
       grasped by laymen, and thus section 801.5 is inapplicable to devices which bear a
       FDA-approved label. See Caplinger, 784 F.3d at 1341; see also 21 C.F.R. § 801.109 (2012).

¶ 34                                  C. Adequacy of the Pleadings
¶ 35       Medtronic argues, in the alternative, that the trial court erroneously denied its petition to
       dismiss plaintiffs’ complaint under section 2-615 of the Code (735 ILCS 5/2-615 (West 2014))
       because it was inadequately pleaded. Plaintiffs respond that Medtronic has waived this
       argument by failing to file a cross-appeal from the trial court’s June 10, 2014, order, which
       denied Medtronic’s initial motion to dismiss. As we have already ruled that plaintiffs’ claims
       are preempted except where they rely on assertions that Medtronic omitted necessary
       information regarding material risks of the Infuse in promoting the device, we address this
       argument only as to those claims.

                                                   -8-
¶ 36        Before addressing the merits of Medtronic’s argument, we must determine whether it is
       properly before this court. Once a trial court enters a finding under Illinois Supreme Court Rule
       304(a) (eff. Feb. 26, 2010) as to an order of dismissal, earlier adverse findings against the
       dismissed defendant also become final and appealable. Argonaut-Midwest Insurance Co. v.
       E.W. Corrigan Construction Co., 338 Ill. App. 3d 423, 426-27 (2003). Generally, “[w]here a
       general decision for the appellee contains findings unfavorable to the appellee and no
       cross-appeal is filed, the adverse findings are not properly before the reviewing court.”
       Cincinnati Insurance Co. v. Chapman, 2016 IL App (1st) 150919, ¶ 27. If the appellee fails to
       file a cross-appeal, the reviewing court is confined to the issues raised by the appellant and will
       only consider the issues raised by the appellee where they are related to the appellant’s issues.
       Ruff v. Industrial Comm’n, 149 Ill. App. 3d 73, 79 (1986). However, when reviewing a
       dismissal under section 2-619 of the Code, we may affirm that dismissal for any reason evident
       in the record. Gunthorp v. Golan, 184 Ill. 2d 432, 438 (1998). Additionally, a party is not
       required to file a cross-appeal where they do not seek reversal of the judgment below. People
       ex rel. Hartigan v. Knecht Services, Inc., 216 Ill. App. 3d 843, 852 (1991). Plaintiffs appeal
       from the trial court’s order dismissing their complaint. Medtronic does not seek to reverse
       judgment. Accordingly, we may consider the adequacy of the pleadings in determining
       whether to affirm that dismissal.
¶ 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

                                                    -9-
       omissions proximately caused the complained of injuries. As the loss of consortium counts are
       derivative of the failure to warn claims, they must also fail. Brown v. Metzger, 118 Ill. App. 3d
       855, 858-59 (1983) (“[W]here the impaired spouse’s claim fails as a matter of law, the
       deprived spouse’s claim for loss of consortium must likewise fail.”).
¶ 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.

¶ 40                                       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.

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