Norabuena v. Medtronic, Inc.

2017 IL App (1st) 162928

• Court: Appellate Court of Illinois
• Decided: September 20, 2017
• Docket: 1-16-2928
• Status: Unpublished

Opinion

2017 IL App (1st) 162928 No. 1-16-2928 Opinion filed September 20, 2017 Third Division

______________________________________________________________________________

IN THE APPELLATE COURT OF ILLINOIS FIRST DISTRICT ______________________________________________________________________________

SENAYDA NORABUENA and MIGUEL ) Appeal from the TORRES, ) Circuit Court of ) Cook County. Plaintiffs-Appellants, ) ) No. 15 L 011806 v. ) ) Honorable MEDTRONIC, INC., MEDTRONIC ) John P. Callahan, SOFAMOR DANEK USA, INC., and ) Judge, presiding. NORTHWESTERN MEMORIAL ) HEALTHCARE, ) ) Defendants. ) ) (Medtronic, Inc., and Medtronic Sofamor ) Danek USA, Inc., Defendants-Appellants.) )

______________________________________________________________________________

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 No. 1-16-2928

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

-2- No. 1-16-2928

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

1 Northwestern Memorial Healthcare was not a party to Medtronic’s motion to dismiss and is not an appellee in the current appeal. -3- No. 1-16-2928

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 the claims are parallel to federal regulations that (1) prohibit false and misleading

-4- No. 1-16-2928

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,

-5- No. 1-16-2928

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.”

-6- No. 1-16-2928

¶ 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

Ҥ 360k does not prevent a State from providing a damages remedy for claims premised on a

-7- No. 1-16-2928

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.

-8- No. 1-16-2928

¶ 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

2 The Second Circuit also addressed a similar case involving the device in question in a non- precedential summary order in Otis-Wisher v. Medtronic, Inc., 616 Fed. Appx. 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. -9- No. 1-16-2928

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:

“[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.

- 10 - No. 1-16-2928

¶ 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

- 11 - No. 1-16-2928

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 non-obvious 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

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

- 12 - No. 1-16-2928

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.

¶ 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.

- 13 - No. 1-16-2928

¶ 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.

¶ 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

- 14 - No. 1-16-2928

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).

- 15 - No. 1-16-2928

¶ 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 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

- 16 - No. 1-16-2928

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 in so far 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.

- 17 -