Cleeton v. SIU Healthcare, Inc. , 2021 IL App (4th) 200490 ( 2021 )

Digitally signed by
Reporter of
Decisions
Reason: I attest to
Illinois Official Reports the accuracy and
integrity of this
document
Appellate Court Date: 2022.06.23
09:41:03 -05'00'
Cleeton v. SIU Healthcare, Inc., 2021 IL App (4th) 200490Appellate Court CAROL CLEETON, as Independent Administrator of the Estate of
Caption Donald Cleeton, Deceased, Plaintiff-Appellant, v. SIU
HEALTHCARE, INC.; CHARLENE YOUNG; ABDULLAH AL
SAWAF, M.D.; STEPHANIE WHOOLEY; SUE FERRILL; and
MEDTRONIC, INC., Defendants (Stephanie Whooley, Sue Ferrill,
and Medtronic, Inc., Defendants-Appellees).
District & No. Fourth District
No. 4-20-0490
Filed August 3, 2021
Decision Under Appeal from the Circuit Court of Sangamon County, No. 19-L-32; the
Review Hon. Raylene Grischow, Judge, presiding.
Judgment Affirmed.
Counsel on Timothy M. Shay, of Shay & Associates Law Firm, of Springfield, for
Appeal appellant.
Aaron P. Bowling, of DLA Piper LLP (US), of Chicago, and Ilana H.
Eisenstein, of DLA Piper LLP (US), of Philadelphia, Pennsylvania,
for appellees.
Panel JUSTICE TURNER delivered the judgment of the court, with opinion.
Presiding Justice Knecht and Justice DeArmond concurred in the
judgment and opinion.
OPINION
¶1 Plaintiff, Carol Cleeton, as the independent administrator of the estate of Donald Cleeton,
deceased, appeals the Sangamon County circuit court’s August 21, 2020, order granting
summary judgment in favor of defendants, Stephanie Whooley, Sue Ferrill, and Medtronic,
Inc. (Medtronic) (collectively, Medtronic Defendants), on counts XVI through XXI of
plaintiff’s amended complaint. On appeal, plaintiff contends the circuit court erred by finding
(1) plaintiff’s negligence claims based on a failure to warn theory were preempted by federal
law and (2) defendants did not owe a duty to decedent under a voluntary undertaking theory.
We affirm.
¶2 I. BACKGROUND
¶3 When he was 17 years old, decedent sustained a cervical cord injury that left him a
quadriplegic. In December 2014, Dr. Jose Espinosa implanted a Medtronic SynchroMed II
programmable pump in decedent to reduce the extent of involuntary muscle spasms decedent
experienced. The pump delivered Lioresal Intrathecal (baclofen) for spasticity control. After
the implantation, decedent’s pump was managed by the Southern Illinois University
Department of Neurology (SIU Neurology).
¶4 On October 25, 2017, decedent, then 25 years old, presented with his mother, Carol
Cleeton, at the SIU Neurology clinic for a routine pump refill. He reported his spasms were
under good control with the current dose of baclofen. Ashley Kochman, R.N., unsuccessfully
attempted to refill decedent’s pump three times. One of the attempts resulted in Kochman
inserting the full length of the refill needle into decedent’s abdomen without making contact
with the pump. Kochman sought assistance with the refill from defendant Charlene Young, a
nurse practitioner. Young was able to refill decedent’s pump on her first or second attempt.
¶5 On October 29, 2017, around 8:15 p.m., decedent arrived at the Memorial Medical Center
emergency room complaining of abdominal pain and a headache since his pump was refilled.
Decedent also noted increased spasms since the refill. He also recently had a urinary tract
infection. Decedent was seen in the emergency room by Dr. Richard Austin. At 8:30 p.m., Dr.
Austin consulted Dr. Jahangir, a neurology resident. The emergency room notes stated Dr.
Jahangir recommended having a Medtronic representative interrogate the device. At 8:46 p.m.,
Jessica Farley, an emergency department nurse, paged a Medtronic representative. Whooley,
a Medtronic sales representative, spoke with Farley, and Farley requested interrogation of
decedent’s pump. Sometime between 11 p.m. and midnight, Whooley arrived at the emergency
room and interrogated decedent’s pump. The interrogation of the pump involved using an
electronic device to read the pump to see how the pump was currently functioning and whether
an alarm had been activated. The interrogation results showed no functional error with the
pump. Whooley also confirmed the pump was programmed correctly. Whooley informed Dr.
Austin of the results of the interrogation but did not give him the “on-label” information
addressing the signs and symptoms for baclofen withdrawal symptoms and the Medtronic
-2-
emergency procedures. Whooley also did not discuss the intrathecal catheter that delivered the
medication from the pump to the spinal canal. The emergency room notes for decedent contain
diagnoses of sepsis and acute urinary tract infection. Dr. Austin admitted decedent to the
hospital and transferred decedent’s care shortly before midnight. In transferring care of
decedent, Dr. Austin spoke with Dr. Nichole Mirocha.
¶6 While hospitalized, decedent’s condition continued to decline. On October 30, 2017,
around 10:45 a.m., a Medtronic employee faxed the emergency procedures for baclofen
withdrawal to Memorial Medical Center after receiving a request for troubleshooting
assistance with decedent’s pump. Sue Ferrill, a clinical specialist with Medtronic, was also
contacted on the morning of October 30, 2017. She was informed about the possibility of a dye
study on decedent’s pump and catheter. The dye study never took place. Also, that morning,
defendant Dr. Abdullah Al Sawaf, the neurologist responsible for managing decedent’s pump,
examined decedent. Decedent was transferred to the intensive care unit where Dr. Mouhamad
Bakir took over care for decedent. A code blue was called around 12:09 p.m. Thereafter,
numerous physicians were consulted, including Dr. Espinosa, who implanted the pump. Dr.
Espinosa recommended intrathecal administration of baclofen, which was done by Dr. Todd
Knox. However, after three hours of resuscitation efforts, decedent was declared dead at 3:06
p.m. Later tests revealed the catheter for decedent’s pump had holes in it.
¶7 In February 2019, plaintiff filed her wrongful death action against SIU Healthcare, Inc.;
Young; and Dr. Al Sawaf. The following were named as respondents in discovery: the
Medtronic Defendants, Memorial Medical Center, Dr. Austin, Dr. Knox, Dr. Bakir, Dr.
Mirocha, and Farley. In October 2019, plaintiff filed a motion to add the Medtronic Defendants
as defendants in this case, which the circuit court granted. Plaintiff added the following counts:
(1) a wrongful death claim against Whooley (count XVI), (2) a survival claim against Whooley
(count XVII), (3) a wrongful death claim against Ferrill (count XVIII), (4) a survival claim
against Ferrill (count XIX), (5) a wrongful death claim against Medtronic under the doctrine
of respondeat superior (count XX), and (6) a survival claim against Medtronic under the
doctrine of respondeat superior (count XXI). (We note plaintiff has added other defendants
and respondents in discovery during the life of this case and the case is still ongoing.)
¶8 The wrongful death claim against Whooley asserted she “undertook the duty to
troubleshoot the Baclofen pump and catheter to verify the proper functioning of the device and
catheter, including the consideration of the disclosure of Medtronic literature addressing
emergency procedures for Baclofen Withdrawal Syndrome.” It asserted, on October 29, 2017,
Whooley committed the following negligent errors and omissions: (1) failed to troubleshoot
the catheter to determine its “patency” and ability to transport the baclofen to its intended
location, (2) failed to ask Dr. Austin about his experience and knowledge of the baclofen pump
and catheter implanted in decedent, (3) failed to contact a physician with knowledge and
expertise with the baclofen pump and catheter implanted in decedent, (4) failed to provide Dr.
Austin or any other health care provider or clinician at Memorial Medical Center the
emergency procedures contained in the Medtronic literature on label for baclofen withdrawal
syndrome, and (5) failed to otherwise troubleshoot and assist medical personnel with the
Medtronic baclofen pump and catheter implanted in decedent.
¶9 As to Ferrill, the wrongful death claim alleged she “undertook the duty of troubleshooting
the Medtronic Baclofen pump and catheter implanted in [decedent].” The count asserted Ferrill
committed one or more of the following negligent acts or omissions: (1) failed to properly
-3-
troubleshoot the Medtronic baclofen pump and catheter implanted in decedent during his
hospital stay of October 29 and 30, 2017, and (2) failed to advise clinicians including
physicians and nurses at Memorial Medical Center of the Medtronic emergency procedures on
label for baclofen withdrawal syndrome.
¶ 10 In June 2020, the Medtronic Defendants filed a motion for summary judgment and a
supporting memorandum with numerous supporting exhibits. Plaintiff filed a response to
summary judgment motion with supporting exhibits and a supplement. The supporting exhibits
included, inter alia, the discovery depositions of Whooley, Ferrill, and Dr. Austin.
¶ 11 In her deposition, Whooley stated she was hired by Medtronic in 2012 as a sales
representative. Her degrees were in business. She sold spinal cord stimulators and intrathecal
drug pumps. In her position, Whooley received training about the product she was selling,
including the SynchroMed II pump implanted in decedent. She also received all of Medtronic’s
written materials concerning the pump. Whooley was also aware of the withdrawal symptoms
of baclofen.
¶ 12 At 9 p.m. on October 29, 2017, Whooley had a telephone call with Farley who informed
Whooley decedent was at the hospital and a request for an interrogation had been made. After
unsuccessfully looking for a Medtronic employee closer to the hospital, Whooley drove from
her home to Memorial Medical Center, a trip of around 1 hour and 15 minutes, to interrogate
decedent’s pump. Whooley explained interrogation involves using an electronic device to read
the pump. The device reads how the pump is functioning and indicates whether an alarm has
been activated, if the pump has stalled, or any other type of system error. The interrogation
would not reveal any difficulties in refilling the pump. A clinician is to update the pump’s
memory after the pump has been refilled.
¶ 13 The interrogation of decedent’s pump “revealed that there was no functional error with the
pump.” Whooley also spoke with decedent’s mother and looked at the pump’s log. Whooley
noted the log’s indication of a refill of the pump coincided with the timeline provided by
decedent’s mother. Whooley further noted a nurse was able to access decedent’s medical
records, and Whooley confirmed the pump was programmed to be running the way the
provider intended the pump to be running. Whooley then provided a pump printout to Dr.
Austin and explained to him the steps she took with the emergency room staff and the
interrogation of decedent’s pump. Whooley did not inquire about Dr. Austin’s experience with
and knowledge about intrathecal baclofen injections. She also did not provide the emergency
procedures for baclofen withdrawal to anyone at Memorial Medical Center on October 29,
2017. Whooley also did not contact Dr. Espinosa or anyone managing decedent’s pump.
¶ 14 Whooley stated her role was specifically “to identify whether the pump itself, the computer
that drives the delivery of the drug, that computer is intact and programmed accordingly.” She
did not consider whether the catheter may have been the problem because that was not her role
as a Medtronic representative. Whooley did explain the catheter could be tested in a number
of ways, including a dye study or fluoroscopy. It was up to the physician to determine the
appropriate test and whether to have a Medtronic representative present at the test. If Dr. Austin
would have questioned whether the catheter was the source of the problem, Whooley would
have explained the options he had for testing a catheter.
¶ 15 In her deposition, Ferrill stated she never saw decedent. On the morning of October 30,
2017, she learned a dye study may have been needed to be performed on decedent’s pump and
catheter. Ferrill was told she would need to assist and provide equipment if the dye study were
-4-
to happen. When Ferrill followed up, she was informed decedent’s condition had worsened
and it was uncertain a dye study would take place.
¶ 16 In his deposition, Dr. Austin stated he had completed his residency four months before
treating decedent on October 29, 2017. Before treating decedent, he had seen patients before
with pumps but did not learn anything about the specifics of the devices. With the prior
patients, he did not have a potential differential diagnosis that involved whether the device was
properly working. Dr. Austin acknowledged he had little knowledge about decedent’s device.
Dr. Austin explained his understanding was that, when a patient presented in the emergency
room with a baclofen pump that may or may not be functioning properly, he was to call the
“managing team.” In decedent’s case, it was the SIU Neurology team. Dr. Austin consulted
Dr. Jahangir, the neurology resident who was on-call for SIU Neurology. Dr. Jahangir
suggested having a Medtronic representative interrogate the device. When asked whether he
would have written in his notes a suggestion about any intrathecal baclofen injections, Dr.
Austin stated that would be beyond the scope of his practice and he would have included any
sort of medication recommendation in his notes.
¶ 17 Dr. Austin further stated he made the associated diagnoses at the end of writing his
emergency room notes for decedent and listed sepsis and acute urinary tract infection as the
associated diagnoses. Dr. Austin explained the diagnoses listed in his notes were for things he
had been able to definitely diagnose. Thus, while baclofen withdrawal was a differential
diagnosis, he did not list it because he did not have enough information to diagnose it. Dr.
Austin noted the Medtronic representative had interrogated the pump and informed him it was
functioning appropriately. He did not recall a discussion about the catheter with the Medtronic
representative. Dr. Austin relied in part on the Medtronic representative’s interrogation results
in focusing on a diagnosis of sepsis and a urinary tract infection. Dr. Austin also explained
sepsis from a urinary tract infection was an incredibly common condition while sepsis from
baclofen withdrawal was a rare condition.
¶ 18 In August 2020, the circuit court held a hearing on the Medtronic Defendants’ motion for
summary judgment and took the matter under advisement. On August 21, 2020, the court
entered a written order granting summary judgment in favor of the Medtronic Defendants. As
to a voluntary undertaking, the court found Whooley’s limited role did not involve her
assuming additional duties of a health-care provider as suggested by plaintiff. It also noted
Ferrill never saw decedent and failed to see how she could be held responsible for decedent’s
care. The court further found the Medtronic Defendants did not owe a duty to diagnose,
troubleshoot, inquire about the doctor’s experience, offer medical advice, or insert themselves
into the middle of the doctor/patient relationship and affirmatively intervene in decedent’s care.
Regarding the catheter, the Medtronic Defendants had no duty to determine whether it was
leaking because they had not been responsible for the pump’s implant, the refill procedure, or
decedent’s care. The court emphasized the physician was responsible for providing medical
care. To impose such a duty would require the Medtronic Defendants to monitor the actions of
the health-care provider. The court concluded plaintiff had not alleged any facts from which it
or a reasonable trier of fact could draw an inference the Medtronic Defendants had or
voluntarily undertook any legal duty beyond those they took at the request of decedent’s
health-care providers.
¶ 19 In finding plaintiff’s failure to warn claims were preempted by federal law, the circuit court
commented, no matter how plaintiff’s counsel set forth the argument, the argument essentially
-5-
was the Medtronic Defendants had a duty to advise decedent’s medical providers of known
information regarding the medical device that was already contained within the on-label
warnings. It noted plaintiff failed to identify any federal directive requiring the Medtronic
Defendants to deliver a separate copy of the Medtronic emergency procedures for baclofen
withdrawal. As such, plaintiff’s claims would impose additional requirements above and
beyond the on-label warning approved by the Food and Drug Administration, and thus those
claims were expressly preempted. On September 11, 2020, the court entered an order stating
its August 21, 2020, order granting summary judgment in favor of the Medtronic Defendants
was a final and appealable order pursuant to Illinois Supreme Court Rule 304(a) (eff. Mar. 8,
2016) and there was no just reason for delaying enforcement or appeal or both.
¶ 20 On October 6, 2020, plaintiff filed a timely notice of appeal in sufficient compliance with
Illinois Supreme Court Rule 303 (eff. July 1, 2017). Accordingly, this court has jurisdiction
under Rule 304(a).
¶ 21 II. ANALYSIS
¶ 22 In this case, plaintiff asserted the Medtronic Defendants were negligent under two different
theories: voluntary undertaking and failure to warn. The circuit court granted summary
judgment in favor of the Medtronic Defendants, finding plaintiff’s failure to warn claims were
preempted by federal law and no evidence showed the Medtronic Defendants voluntarily
undertook any legal duty to take steps beyond those they took at the request of the treating
health-care providers. Plaintiff contends the circuit court’s grant of summary judgment in favor
of the Medtronic Defendants was improper.
¶ 23 A grant of summary judgment is proper when “the pleadings, depositions, admissions, and
affidavits on file establish that there is no genuine issue of material fact and that the moving
party is entitled to judgment as a matter of law.” Gillespie v. Edmier, 2020 IL 125262, ¶ 9
(citing 735 ILCS 5/2-1005(c) (West 2018)). When determining whether a genuine issue of
material fact exists, the reviewing court must construe the pleadings, depositions, admissions,
and affidavits strictly against the movant. Gillespie, 2020 IL 125262, ¶ 9. “We review a motion
for summary judgment in the light most favorable to the nonmoving party.” Gillespie, 2020 IL
125262, ¶ 9. This court reviews de novo a circuit court’s order granting summary judgment.
Gillespie, 2020 IL 125262, ¶ 9.
¶ 24 A. Failure to Warn
¶ 25 Plaintiff first contends the circuit court erred by finding her claims of failure to warn were
preempted by federal law. She claims she made no allegations that would trigger federal
preemption under the Medical Device Amendments of 1976 (the Amendments) to the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq. (2018)). The Medtronic Defendants
contend the circuit court properly found plaintiff’s claims preempted because the claims would
impose additional requirements above and beyond those approved by the federal Food and
Drug Administration.
¶ 26 In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the United States Supreme Court
considered whether the preemption clause in the Amendments (21 U.S.C. § 360k(a) (2006))
barred common law claims challenging the safety and effectiveness of a medical device given
premarket approval by the federal Food and Drug Administration. The plaintiff’s claims
included strict liability; breach of implied warranty; and negligence in the design, testing,
-6-
inspection, distribution, labeling, marketing, and sale of the medical device. Riegel, 552 U.S.
at 320. In analyzing whether the preemption clause applied, the Riegel court considered
(1) whether the federal government had established requirements applicable to the medical
device and, if so, (2) whether the plaintiff’s common law claims for strict product liability and
negligence were based on state requirements with respect to the medical device that are
“ ‘different from, or in addition to,’ ” the federal requirements and related to safety and
effectiveness. Riegel, 552 U.S. at 321-22 (quoting 21 U.S.C. § 360k(a)(1)).
¶ 27 As to the first consideration, the state requirements are preempted only when the Food and
Drug Administration has established specific requirements applicable to a particular device.
Riegel, 552 U.S. at 322. The Riegel Court determined the premarket approval of Class III
medical devices is specific to individual devices and constitutes federal safety review. Riegel,
552 U.S. at 323. Regarding the second consideration, the Supreme Court rejected the
suggestion common-law tort duties are excluded from the scope of preemption. Riegel, 552
U.S. at 324-25. It adhered to a prior finding “common-law causes of action for negligence and
strict liability do impose ‘requirement[s]’ and would be pre-empted by federal requirements
specific to a medical device.” Riegel, 552 U.S. at 323-24. However, state-law claims of strict
products liability and negligence are preempted under the Amendments “only to the extent that
they are ‘different from, or in addition to’ the requirements imposed by federal law.” Riegel,
552 U.S. at 330 (quoting 21 U.S.C. § 360k(a)(1)). In other words, common-law claims would
not be preempted if they were “ ‘parallel’ ” to the federal requirements, such as if the claims
were for damages premised upon a violation of Food and Drug Administration regulations.
Riegel, 552 U.S. at 330 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)). On the
facts before it, the Riegel Court affirmed the dismissal of the plaintiff’s state-law claims against
the manufacturer of a Class III premarket approved device because the claims were preempted
by the Act. Riegel, 552 U.S. at 330.
¶ 28 In this case, plaintiff’s claim based on a failure to warn theory asserted the Medtronic
Defendants failed to provide Dr. Austin or any other health-care provider or clinician the
emergency procedures contained in the Medtronic literature on label for baclofen withdrawal
syndrome. Plaintiff contends Riegel provides little guidance in this matter because her claim
is outside of the design, manufacturing, and/or labeling of a device. In support of her argument,
plaintiff cites a decision by the Indiana Appellate Court, Medtronic, Inc. v. Malander, 996
N.E.2d 412, 419, 421 (Ind. Ct. App. 2013), where the reviewing court affirmed the denial of
the defendant’s motion for summary judgment, finding the plaintiff’s negligence claim was
not preempted by federal law and a genuine issue of material fact existed as to whether the
defendant assumed a duty to the decedent.
¶ 29 In Malander, 996 N.E.2d at 414, a physician had implanted a defibrillator and a “Lead”
made by the defendant into the decedent (the plaintiffs were the decedent’s wife and estate).
During a follow-up appointment, the physician learned the device in the decedent had
experienced nine episodes of random “short V-V intervals” and scheduled the decedent for a
surgery to upgrade the defibrillator and possibly replace the Lead. Malander, 996 N.E.2d at
414. The defendant’s clinical specialist was present at the surgery and assisted the physician
in testing the Lead, which did not reveal any problems. Malander, 996 N.E.2d at 414. The
physician also called and spoke to two of the defendant’s employees in the technical services
department and asked for information about the short V-V intervals. Malander, 996 N.E.2d at
414. One of the employees told the physician not to worry about it and the employee did not
-7-
think it was a problem. Malander, 996 N.E.2d at 414. The physician did not replace the Lead,
and the decedent died following an incident of ventricular tachycardia. Malander, 996 N.E.2d
at 414. Testing of the device showed short V-V intervals during the two weeks before the
tachycardia. Malander, 996 N.E.2d at 414. One of the plaintiffs’ claims asserted the defendant
was negligent for failing to recommend the Lead be removed or capped off during the
decedent’s surgery. Malander, 996 N.E.2d at 415. The plaintiffs alleged the defendant had
distributed memoranda to their technicians prior to the decedent’s surgery that indicated short
V-V intervals were indicative of lead failure and the technicians should have recommended
replacement of the Lead. Malander, 996 N.E.2d at 415.
¶ 30 The defendant argued the plaintiffs’ failed to allege a parallel claim because plaintiffs’
claim was essentially the defendant’s technicians should have provided additional warnings
above and beyond the warnings on the device’s label. Malander, 996 N.E.2d at 417. The
plaintiffs countered their claim involved negligent oral representations by the defendant’s
technicians and not the device’s labeling. Malander, 996 N.E.2d at 417. The reviewing court
found the plaintiffs’ claim related to oral representations made by the defendant’s
representatives during a surgical procedure regarding a specific device’s performance and not
general allegations regarding the labeling, design, or manufacture of the device. Malander, 996
N.E.2d at 418. It then addressed several decisions by other courts addressing oral
representations by the manufacturer’s employees. Malander, 996 N.E.2d at 418-19.
¶ 31 Two of the decisions found preemption and one did not. One of the cases finding
preemption involved a manufacturer’s representative physician informing the physician’s
nurse the medical pump would continue working for approximately four weeks after the low
battery alarm alerted. Malander, 996 N.E.2d at 418 (citing Baker v. Medtronic, Inc., No. 2:99-
CV-1355, 2002 WL 485013 (S.D. Ohio Mar. 28, 2002)). Four days before the surgery to
replace the pump, the battery failed. Malander, 996 N.E.2d at 418 (citing Baker, 2002 WL
485013, at *1-2). The plaintiff brought an action against the manufacturer and argued, in part,
the manufacturer’s representative’s statements were “ ‘off label representations’ ” and not
regulated by the Food and Drug Administration. Malander, 996 N.E.2d at 418 (quoting Baker,
2002 WL 485013, at *8). The court found the information given to the physician’s nurse was
consistent with the information in the pump’s labeling, and thus the information was not an
“ ‘off label’ representation.” Malander, 996 N.E.2d at 418 (quoting Baker, 2002 WL 485013,
at *8). The Malander court was dismissive of the other case finding preemption because of its
lack of analysis and found the third case, Adkins v. CYTYC Corp., No. 4:07CV00053, 2008
WL 2680474 (W.D. Va. July 3, 2008), more persuasive. Malander, 996 N.E.2d at 419. In
Adkins, the manufacturer’s representative was in the operating room “ ‘and advised and
directed [the doctor] on the proper way’ to use the device.” Malander, 996 N.E.2d at 419(quoting Adkins, 2008 WL 2680474, at *1). “The plaintiff brought an action against the
manufacturer ‘alleging breach of implied warranty of merchantability, breach of express
warranty, negligence through inadequate design and negligent warnings or instruction of the
surgeon by [the] defendants’ corporate representative.’ ” Malander, 996 N.E.2d at 419(quoting Adkins, 2008 WL 2680474, at *1). The court concluded the plaintiff’s cause of action
regarding the manufacturer’s representative’s direct actions “ ‘during the surgery in
negligently instructing the operating physician’ were not governed by Riegel’s preemption
holding.” Malander, 996 N.E.2d at 419 (quoting Adkins, 2008 WL 2680474, at *2). It found
the Food and Drug Administration did not regulate interactions between the manufacturer’s
-8-
representatives and physicians on-site at a surgery and such localized situations are traditional
matters for the common law. Malander, 996 N.E.2d at 419 (citing Adkins, 2008 WL 2680474,
at *3).
¶ 32 The Malander court concluded the plaintiffs’ claim was not preempted by the
Amendments. Malander, 996 N.E.2d at 419. It noted, unlike in Baker, the plaintiffs’ claim did
not involve the mere restatement of information given in the labeling. Malander, 996 N.E.2d
at 419. Moreover, the Malander court found the plaintiffs’ claim was similar to Adkins since
their claim did not concern the design, manufacture, or labeling of the Lead. Malander, 996
N.E.2d at 419.
¶ 33 In this case, the parties agree the first Riegel requirement is met. Plaintiff contends the
second requirement for preemption is not met because her amended complaint asserts the
Medtronic Defendants were negligent based on their own actions or inactions that led to
decedent’s death. She contends the negligent performance of job duties is not preempted under
the Amendments. Plaintiff alleges the court’s ruling in Malander is instructive. However, the
facts of this case are more similar to Baker cited in Malander than to the facts of Malander
and Adkins. Plaintiff alleged in her amended complaint Whooley and Ferrill should have given
decedent’s health-care providers the emergency procedures contained in the label for the
device. The information contained in the label is clearly controlled by the Food and Drug
Administration. To suggest employees had to supply the emergency procedures in addition to
the label suggests the label approved by the Food and Drug Administration was insufficient or,
stated differently, that additional warnings were required. We agree with the circuit court
plaintiff’s claim would impose additional requirements above the warnings approved by the
Food and Drug Administration. We find no reason why Dr. Austin’s lack of knowledge should
alter the aforementioned conclusion. Accordingly, this court finds plaintiff’s claims based on
a failure to warn theory are preempted by federal law. As such, we do not address plaintiff’s
other arguments her claims based on a failure to warn survive a motion for summary judgment.
¶ 34 B. Voluntary Undertaking
¶ 35 Plaintiff also asserted negligence claims based on a voluntary undertaking theory. She
contends the circuit court incorrectly identified the assumed duty of care alleged in her
complaint and emphasizes her claims assert a duty to provide technical support. “Whether a
duty exists is a question of law for the court to decide.” Bogenberger v. Pi Kappa Alpha Corp.,
2018 IL 120951, ¶ 21, 104 N.E.3d 1110.
¶ 36 Citing Luna v. Pizzas by Marchelloni, 279 Ill. App. 3d 402, 404, 664 N.E.2d 1112, 1114
(1996), plaintiff notes a person can be liable for negligent performance of a voluntary
undertaking. “Pursuant to the voluntary undertaking theory of liability, one who gratuitously
renders services to another is subject to liability for bodily harm caused to the other by one’s
failure to exercise due care or ‘such competence and skill as [one] possesses.’ ” (Internal
quotation marks omitted.) Luna, 279 Ill. App. 3d at 404 (quoting Cross v. Wells Fargo Alarm
Services, 82 Ill. 2d 313, 317, 412 N.E.2d 472, 474 (1980)). Illinois courts have adopted section
324(A) of the Restatement (Second) of Torts in analyzing voluntary undertaking claims.
Kennedy v. Medtronic, Inc., 366 Ill. App. 3d 298, 308, 851 N.E.2d 778, 786 (2006). That
section provides, in pertinent part, the following:
“One who undertakes, gratuitously or for consideration, to render services to
another which he should recognize as necessary for the protection of a third person or
-9-
his things, is subject to liability to the third person for physical harm resulting from his
failure to exercise reasonable care to protect his undertaking, if
(a) his failure to exercise reasonable care increases the risk of such harm[.]”
Restatement (Second) of Torts § 324A (1965).
“ ‘Under the voluntary undertaking theory of liability, the duty of care to be imposed on a
defendant is limited to the extent of the undertaking.’ ” Kennedy, 366 Ill. App. 3d at 308(quoting Lange v. Fisher Real Estate Development Corp., 358 Ill. App. 3d 962, 973, 832
N.E.2d 274, 282 (2005)); Bell v. Hutsell, 2011 IL 110724, ¶ 12, 955 N.E.2d 1099. “The theory
is narrowly construed.” Bell, 2011 IL 110724, ¶ 12.
¶ 37 In support of her voluntary undertaking argument, plaintiff again cites the Indiana
Appellate Court’s decision in Malander. There, the reviewing court found the defendant had
not assumed a duty to make medical recommendations but, rather, had assumed a duty to make
“ ‘technical’ recommendations.” Malander, 996 N.E.2d at 420-21. Having volunteered to
provide technical support, the defendant assumed a duty to provide that support in a reasonable
and prudent manner. Malander, 996 N.E.2d at 421. The reviewing court noted the defendant’s
“failure to exercise reasonable care in giving technical support would clearly increase the risk
of harm to a patient.” Malander, 996 N.E.2d at 421. The plaintiffs’ supporting evidence
showed the defendant’s technician was present in the operating room and the physician talked
on the telephone to additional technicians regarding “the short V-V intervals experienced by
[the decedent]’s Lead.” Malander, 996 N.E.2d at 421. The plaintiffs also provided supporting
evidence the defendant’s “technicians failed to follow the recommendations of its own internal
memoranda regarding the short V-V intervals associated with this particular lead.” Malander,
996 N.E.2d at 421. While the defendant did provide supporting evidence the small number of
short V-V intervals associated with the decedent’s Lead would not have been concerning, a
genuine issue of material fact existed. Malander, 996 N.E.2d at 421.
¶ 38 The Medtronic Defendants assert Malander is distinguishable and this case is more like
Kennedy, 366 Ill. App. 3d at 309, where the reviewing court affirmed the grant of summary
judgment in favor of the defendant because the defendant did not owe a legal duty to the
decedent that would support the plaintiff’s negligence cause of action. There, the physician
surgically implanted a pacemaker made by the defendant into the decedent at an outpatient
facility. Kennedy, 366 Ill. App. 3d at 300. A clinical specialist for the defendant was present
during the surgery to provide “technical support to ensure the lead parameters were correctly
calibrated and the lead was functioning properly.” Kennedy, 366 Ill. App. 3d at 301. After the
surgery, the decedent experienced health problems, and it was discovered the lead to the
pacemaker had been placed in the left ventricle of the heart. Kennedy, 366 Ill. App. 3d at 301.
The decedent died, and the administrator of the decedent’s estate brought a negligence action
against the defendant, asserting the defendant was negligent in selling the pacemaker to the
physician and through its participation and assistance in the pacemaker implant surgery.
Kennedy, 366 Ill. App. 3d at 301, 303. The circuit court granted summary judgment in the
defendant’s favor, and the plaintiff appealed. Kennedy, 366 Ill. App. 3d at 303.
¶ 39 On appeal, the plaintiff argued the defendant owed the decedent the following three duties:
(1) to refrain from providing a pacemaker to the physician and from participating in the
insertion of the pacemaker when the clinical technician knew the physician intended to proceed
in an inadequate facility without qualified personnel present and without monitoring any of the
decedent’s vital signs; (2) to warn of the dangers inherent in proceeding with the surgery under
- 10 -
the conditions present; and (3) to assist with the insertion in a reasonable manner once it
voluntarily undertook to participate. Kennedy, 366 Ill. App. 3d at 303. As to the voluntary
undertaking claim, the reviewing court rejected the plaintiff’s claim the defendant voluntarily
assumed a duty. Kennedy, 366 Ill. App. 3d at 308. It found the defendant’s clinical specialist
attended the decedent’s surgery to provide technical support and ensure the lead parameters
were correctly calibrated and the lead was functioning properly. Kennedy, 366 Ill. App. 3d at
308. It further found that limited role did not include the clinical specialist voluntarily assuming
a duty for the placement of the lead into the correct ventricle of the decedent’s heart. Kennedy,
366 Ill. App. 3d at 308. The reviewing court also rejected the plaintiff’s contention the
defendant voluntarily assumed a duty based simply upon a brief conversation between its
clinical specialist and the plaintiff during which the clinical specialist allegedly reassured the
plaintiff prior to her father’s surgery. Kennedy, 366 Ill. App. 3d at 308.
¶ 40 1. Whooley
¶ 41 In her amended complaint, plaintiff asserted Whooley “undertook the duty to troubleshoot
the Baclofen pump and catheter to verify the proper functioning of the device and catheter,
including the consideration of the disclosure of Medtronic literature addressing emergency
room procedures for Baclofen Withdrawal Syndrome.” On appeal, plaintiff abandons the
assertion Whooley undertook the duty to troubleshoot the catheter. Instead, in her appellant
brief, plaintiff contends Whooley did not execute her duty to troubleshoot the pump in a
reasonable and prudent manner because she incompletely communicated the results of her
interrogation of the pump to Dr. Austin. Plaintiff contends Whooley did not inform Dr. Austin
of the following: (1) the fact the interrogation did not find a problem did not rule out all
potential issues stemming from the pump, (2) the interrogation did not test the “patency” of
the catheter, and (3) catheters are a common source of complications with the device that could
potentially cause baclofen withdrawal syndrome. Plaintiff argues Whooley had a far greater
understanding of the limitations of the interrogation and the risks of baclofen withdrawal
syndrome related to the pump than Dr. Austin. She notes Dr. Austin relied on her interrogation
report in ruling out baclofen withdrawal as the likely cause of decedent’s symptoms. The
Medtronic Defendants disagree and contend Whooley accurately reported the results of the
interrogation to Dr. Austin. They contend requiring Whooley to inform Dr. Austin of the
aforementioned information about the interrogation constitutes intervening in decedent’s
treatment plan. Moreover, they assert plaintiff’s arguments are not supported by Illinois law.
¶ 42 As stated, the duty of care imposed upon the defendant under a voluntary undertaking
theory is limited to the extent of the undertaking and is narrowly construed. Bell, 2011 IL
110724, ¶ 12. Similar to the clinical specialist in Kennedy, the evidence before the circuit court
on the summary judgment motion showed Whooley only voluntarily undertook a duty to
determine whether the pump itself was functioning as intended by the medical team managing
decedent’s pump. No evidence indicated she undertook a duty to ensure decedent was actually
receiving the baclofen in his spinal canal. We note plaintiff’s suggestion Whooley had a duty
to troubleshoot with Dr. Austin all possible issues with the pump’s delivery of the baclofen
based on Medtronic’s internal documents was insufficiently argued in the appellant brief.
Plaintiff did not cite to any legal authority, and the argument itself is brief and conclusory.
¶ 43 Whooley’s deposition testimony demonstrates testing the integrity of the pump and the
integrity of the catheter are two distinct and separate tests. Whooley explained an interrogation
- 11 -
of the pump involved using an electronic device to read the pump to see how the pump was
currently functioning and whether an alarm had been activated. During an interrogation, the
pump itself was not accessed, and thus, the interrogation was noninvasive. A test of the catheter
could be done “a number of ways,” including a dye test, and it was the physician who chose
which test was most appropriate for the patient.
¶ 44 In this case, the supporting evidence shows Whooley was only asked to interrogate
decedent’s pump. Dr. Jahangir, the on-call physician for the SIU Neurology team who was
managing decedent’s pump, recommended Dr. Austin have Medtronic interrogate the device.
Whooley received a text message from a national answering service with the request to
interrogate decedent’s pump that day. Whooley called the telephone listed in the text, and
Farley, decedent’s emergency room nurse, stated a request had been made for “an
interrogation.” Whooley went to the hospital and interrogated decedent’s pump. She also spoke
with decedent’s mother and looked at the pump’s log. Whooley noted the log coincided with
the timeline provided by decedent’s mother. Whooley further explained a nurse was able to
access decedent’s medical records, and Whooley confirmed the pump was programmed to be
running the way the provider intended the pump to be running. Whooley then provided a pump
printout to decedent’s mother and Dr. Austin. She also explained to Dr. Austin the steps that
she took with emergency room staff and the interrogation of the device. Whooley stated her
role was specifically “to identify whether the pump itself, the computer that drives the delivery
of the drug, that computer is intact and programmed correctly.” Plaintiff acknowledges
Whooley arguably met her duty of care in performing the interrogation.
¶ 45 However, plaintiff claims Whooley did not use reasonable care in reporting the
interrogation findings because Whooley failed to communicate to Dr. Austin the significance
and limitations of the interrogation’s findings. Plaintiff cites no case law in support of her
argument. Instead, plaintiff emphasizes Whooley’s superior knowledge about the pump and
possible problems with it compared to Dr. Austin. That argument overlooks the fact it was Dr.
Austin who was the person responsible for decedent’s care at the time of the interrogation and
he was aware of his own limited knowledge about the pump. Dr. Austin could have asked
Whooley more questions about the pump and the interrogation, or he could have talked to Dr.
Jahangir, who had recommended the interrogation of the pump. As the Medtronic Defendants
observe, to require Whooley to explain the limitations of the test and possible catheter issues
would require a medical device sales representative with no medical training to volunteer
theories about the cause of the patient’s symptoms and thus intervene in the patient’s treatment.
In this case, besides baclofen withdrawal, Dr. Austin was considering other reasons for
decedent’s symptoms. Whooley had no way of knowing what information beyond the
interrogation results Dr. Austin needed in making his clinical judgment. Thus, we disagree
reasonable care includes informing the ordering physician of additional possible issues with
baclofen treatment or sua sponte educating the physician about the pump.
¶ 46 Additionally, we note this case is different from Malander where the defendant’s
employees gave information to the physician that was inconsistent with the defendant’s
internal memoranda. Here, plaintiff is asserting Whooley should have provided more
information and not that she provided incorrect information.
¶ 47 In this case, plaintiff has failed to identify a genuine issue of material fact showing
Whooley did not use reasonable care in exercising her assumed duty to interrogate decedent’s
pump. As such, summary judgment in Whooley’s favor was proper as to the claims based on
- 12 -
a theory of a voluntary undertaking.
¶ 48 2. Ferrill
¶ 49 On appeal, plaintiff asserts Ferrill undertook a duty to maintain and troubleshoot decedent’s
pump. She does not further elaborate on the duty and does not allege how Ferrill did not
perform her duties in a reasonable manner to prevent harm to decedent. The Medtronic
Defendants contend Ferrill was never involved in decedent’s care and thus could not have
owed decedent any of the alleged duties. Plaintiff did not reply to the Medtronic Defendants’
argument. Accordingly, we find plaintiff failed to show Ferrill owed a duty to decedent and
summary judgment in favor of Ferrill on the claims based on a voluntary undertaking theory
was proper.
¶ 50 3. Medtronic
¶ 51 Plaintiff’s claims against Medtronic were based on respondeat superior and, thus, entirely
derivative. Moy v. County of Cook, 159 Ill. 2d 519, 524, 640 N.E.2d 926, 928 (1994). Since
we have found the circuit court properly granted summary judgment in favor of Whooley and
Ferrill, the court also properly granted summary judgment in favor of Medtronic.
¶ 52 III. CONCLUSION
¶ 53 For the reasons stated, we affirm the Sangamon County circuit court’s judgment.
¶ 54 Affirmed.
- 13 -