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

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
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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.
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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
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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,
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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.”
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¶ 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
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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.
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¶ 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.
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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.
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¶ 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
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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
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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.
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¶ 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
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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).
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¶ 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
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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.
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