Court of Appeals of Illinois, First District, Fourth Division
from the Circuit Court of Cook County 08 L 012426 Honorable
James M. McGing, Judge Presiding
PRESIDING JUSTICE McBRIDE delivered the judgment of the
court, with opinion. Justices Gordon and Reyes concurred in
the judgment and opinion.
McBRIDE PRESIDING JUSTICE
1 Plaintiff, Maureen Obermeier, brought various claims
against defendants, Northwestern Memorial Hospital (NMH),
Northwestern Medical Faculty Foundation (NMFF), Patrick
McCarthy, M.D. (Dr. McCarthy), and Edwards Lifesciences, LLC
(Edwards), arising out of a heart surgery Dr. McCarthy
performed on her in November 2006. Plaintiff generally
contended that Dr. McCarthy utilized a medical device called
a "Myxo ring" during the surgery, which was
invented by Dr. McCarthy and manufactured by Edwards.
Plaintiff claimed that the Myxo ring had not been approved or
cleared by the FDA, that it was investigational, and that Dr.
McCarthy improperly utilized the Myxo ring during her surgery
as part of a study. Following a 14-day jury trial, the jury
found in favor of defendants and against plaintiff on all
2 As an initial matter, this court notes that the record in
this case is voluminous, consisting of 17 electronic volumes,
many of which contain between 3000 and 5000 pages each. Due
to the extensive nature of the trial court proceedings and
the various issues raised in this appeal, we will initially
recite a general overview of the proceedings and the evidence
elicited at trial, and we will include a more specific
discussion of the facts relevant to the various issues in
their respective sections.
3 Of plaintiff's 12-count third-amended complaint, 5
counts were dismissed pursuant to defendants' motions to
dismiss, and summary judgment was entered in favor of
defendants on 4 other counts. Those counts included all
counts against defendant Edwards, and accordingly, Edwards
was dismissed from the case prior to trial. The remaining
three counts against NMH, NMFF, and Dr. McCarthy
(collectively, the Northwestern defendants), proceeded to
trial. The remaining three counts were: Count VII,
"Informed Consent versus Dr. McCarthy, with [NMFF] and
[NMH] via agency"; Count IX, "Medical Battery
versus Dr. McCarthy, with [NMFF] and [NMH] via agency"
and Count XII, "Medical Negligence versus Dr. McCarthy,
with [NMFF] and [NMH] via agency."
4 At trial, evidence was presented showing that plaintiff
underwent heart surgery to repair her mitral valve on
November 6, 2006, at NMH. The mitral valve is a valve in the
heart which allows blood to flow from the left atrium to the
5 Plaintiff had been a long-time patient of cardiologist,
Paul Silverman, M.D. Dr. Silverman first treated plaintiff in
2001 in the Emergency Department of Advocate Christ Medical
Center. At that time, plaintiff reported a history of mitral
valve prolapse, a condition in which the mitral valve does
not close properly. Plaintiff then underwent an
echocardiogram which confirmed the existence of that
6 Dr. Silverman assessed plaintiff periodically with imaging
studies to evaluate the progression of her disease. By August
2006, an echocardiogram demonstrated severe mitral
regurgitation, meaning that blood was leaking backwards
through the mitral valve. Dr. Silverman believed that
plaintiff required a surgical consultation to determine
whether the valve required repair or replacement.
7 On September 21, 2006, plaintiff was examined and consulted
with Dr. McCarthy, who specialized in the performance of
mitral valve surgeries. Dr. McCarthy recommended surgery.
8 On November 6, 2006, Dr. McCarthy performed surgery on
plaintiff's mitral valve. As part of that surgery, he
implanted an annuloplasty ring. An annuloplasty ring is
utilized during the surgical repair of a diseased mitral
valve to stabilize the repaired tissues, thereby improving
the function of the mitral valve leaflets so that they open
and close properly. Annuloplasty rings are Class II medical
devices pursuant to regulations issued by the federal Food
and Drug Administration (FDA).
9 During his testimony, Dr. McCarthy explained the surgery
procedures that were performed on plaintiff. Specifically, in
order to repair plaintiff's mitral valve, Dr. McCarthy
selected a particular type of annuloplasty ring, specifically
a 36 millimeter "Myxo ring" from among various
annuloplasty rings that were available to him. The decision
about what specific size and type of annuloplasty ring to use
could not be made until the open heart procedure was underway
and the mitral valve was evaluated. Dr. McCarthy testified
that at the time of plaintiff's surgery, there were about
five or six types of annuloplasty rings in different sizes
that were available as possible options.
10 Dr. McCarthy testified that he invented the Myxo ring that
was utilized during plaintiff's mitral valve repair
surgery. He had the idea for the Myxo ring because for years
he and other valve surgeons had been using larger rings and
bending them to the shape needed in patients who suffered
from myxomatous valve disease. He approached a manufacturer,
Edwards, and suggested that it would be helpful if they could
create a ring that was pre-bent to the shape he had been
11 The Edwards engineers created prototypes and showed them
to him, and by March 2006, Edwards had supplied the Myxo ring
to Dr. McCarthy to utilize in patient surgeries.
12 Dr. McCarthy had previously been involved in the invention
process of two other annuloplasty rings manufactured by
Edwards. In those cases, he also explained to engineers at
Edwards the shape of the ring that he was looking for, and
they created prototypes and showed them to him. Eventually
Edwards started manufacturing the rings. Dr. McCarthy was not
aware of what the FDA clearance process was, and Dr. McCarthy
had not discussed the FDA clearance process or been involved
in the FDA clearance process. No clinical trials,
"Institutional Review Board" (IRB) process, or
special patient consent had been required before the first
clinical use with either of those rings.
13 Dr. McCarthy testified that he had previously been
involved in clinical trials of investigational devices, and
he knew how to conduct a clinical trial. He was aware that
there was a difference between "investigational
devices" and "non-investigational devices." In
his experience, with an investigational device, the
manufacturer contacts the physician and advises the physician
that the investigational device must be tested. The
manufacturer must obtain an "IDE" [investigational
device exemption] from the FDA, and a formal, randomized
clinical trial must be set up. The manufacturer must enter
into a contract with the University, and the clinical trial
is subjected to an involved IRB process, which includes
specific approval of a written consent specifically for the
trial, establishing the duration of the trial, and
establishing the number of patients that will be involved in
the trial. In addition, when a manufacturer provides
investigational devices to a physician for use in a human
subject, it is shipped in packaging clearly marked
"Investigational." Dr. McCarthy testified that
there was a "night and day difference" between
using an investigational device and a non-investigational
14 Dr. McCarthy further testified that the process that
Edwards utilized with the Myxo ring was not at all like the
process a manufacturer uses with an investigational device.
As with the prior rings that Dr. McCarthy invented and
Edwards manufactured, Dr. McCarthy was not aware of what the
FDA clearance process for the Myxo ring was. He was not
involved in any way in the FDA clearance process, and he did
not discuss with Edwards the manner of FDA clearance. Edwards
did not utilize the "investigational device"
process before it provided the Myxo ring to Dr. McCarthy.
There was no clinical trial set up for the Myxo ring. If Dr.
McCarthy believed that the Myxo ring was an investigational
device, it would not have been a problem for Dr. McCarthy to
submit it to the IRB for a clinical trial.
15 Janice Knuckey, a nurse practitioner at NMFF also
testified at trial. She worked in the outpatient cardiac
surgery office and met with patients preoperatively to give
them instructions. Nurse Knuckey met with plaintiff on
October 10, 2006, to review surgical consent forms with
plaintiff and witness her signature. She did not present
consent forms to plaintiff regarding a Myxo ring study
because there was no Myxo ring study. Nurse Knuckey was aware
that Dr. McCarthy's custom was to inform patients that an
annuloplasty ring would be used during mitral valve repair
surgeries, and that it would be used to bring the valve back
to its normal shape.
16 Anna Huskin, R.N, testified that she was employed by
Northwestern University as the Research Manager in the Bluhm
Cardiovascular Institute (BCI), Clinical Trials Unit. Nurse
Huskin works with physicians within the BCI to get their
research projects up and running and helps write protocols
and IRB approved consent forms. She also works with
industry-sponsored projects, where a company approaches a BCI
physician to conduct a research study, and she helps get the
study up and running, including IRB approval of a consent
form for a clinical study.
17 Nurse Huskin has dealt with many unapproved devices over
the years. They take a substantially different path than
cleared devices before they can be used within a hospital. If
a device has not yet been cleared by the FDA, the
manufacturer sends it through the Clinical Trials Unit. If a
device is unapproved, the manufacturer must mark the product
as an "investigational device." The only devices
that come through the doors of Nurse Huskin's unit are
investigational devices. The Clinical Trials Unit relies on
the manufacturer to tell them when a device is
18 Before an investigational device goes to the Clinical
Trials Unit, the manufacturer sends a variety of materials,
including a study protocol, a draft consent form,
instructions how to handle the device, and materials that the
patient must review. The materials will also include an IDE
number, which is assigned by the FDA. It is the manufacturer
who contacts the FDA and asks for an IDE. When Nurse Huskin
receives those materials, she submits the materials from the
manufacturer to the IRB to obtain their approval and make
sure that the IRB is satisfied. Only after full IRB approval
is obtained, and after the manufacturer has an executed
contract back from Northwestern University, can the
investigational devices be shipped to the Clinical Trials
19 The investigational devices are only handled by a research
team in the Clinical Trials Unit. They are kept in a location
separate from commercially available devices that are used in
the hospital, and they are labeled in big, bold letters as
"Investigational." Nurse Huskin testified that
there is no mistaking an investigational device's
labeling when it is shipped.
20 Nurse Huskin further testified that the Myxo ring was
never shipped to the Clinical Trials Unit, and it did not
come through Nurse Huskin's office. Her understanding was
that the Myxo ring was approved, since it was shipped
commercially through standard channels. No one from Edwards
suggested to her or to anyone else at the Clinical Trials
Unit that the Myxo ring had not been cleared by the FDA. If
they had been told that, there would have been a completely
different process. Neither she nor Dr. McCarthy had any role
in deciding whether something is an investigational device.
Nurse Huskin testified that there are thousands of
FDA-regulated medical devices that are used in a hospital
every day. The institution receives those products from
manufacturers, assuming that they are being marketed
according to FDA requirements. Northwestern University's
IRB does not deal with what path a device goes through for
FDA clearance. Nurse Huskin and the people at NMH rely on
manufacturers to alert them if a device is investigational.
21 Nurse Huskin was aware that Dr. McCarthy authored a paper
on the Myxo ring. She had helped work on it by pulling
patient information on patients who underwent myxomatous
mitral valve repair surgery. Nurse Huskin testified that she
would not characterize it as a "study," but rather
a "retrospective chart review." A "study"
has more of an organized design where patients are followed
at specific intervals. The information that was used for the
papers was gathered from the "Outcomes Registry"
and there was approval to study or evaluate the data that was
within that database.
22 Plaintiff signed a consent form to be part of the Outcomes
Registry at Northwestern University. The Cardiac Surgery
Outcomes Registry is a large-scale registry that the Clinical
Trials Unit runs. Nurse Huskin has been involved with the
Outcomes Registry since its inception. It is a project where
they collect information on all cardiac surgery patients who
are undergoing cardiac surgery. The Society of Thoracic
Surgeons (STS) has a national registry/database, and they
encourage teaching institutions across the country to gather
information for the purpose of conducting studies after
patients receive care, maintaining quality, and to better
understand how patients have responded to different modes of
treatment. Among the information that is captured on a
patient is any device that is used in cardiac surgery.
23 NMH has a quality assurance initiative to submit data to
the STS national database. The Clinical Trials Unit seeks to
obtain the consent of all cardiac surgery patients to allow
the CTU to maintain the patient's data in the
Northwestern University Cardiac Surgery Outcomes Registry as
well as the STS national database. The Outcomes Registry has
been in existence since 2005, and it is approved by the IRB.
After the patient has consented to the Outcomes Registry, all
data from the STS database also goes to the Outcomes
Registry, which allows Northwestern University to review the
database, and to have papers written like that of Dr.
McCarthy. Over the years, Nurse Huskin has been involved in
over 100 projects similar to the paper that Dr. McCarthy
published. In those situations, the physician goes back and
searches the database for patients who have already undergone
care and puts the information into a publication. In all
those cases, the consent that the patient signed that
justified going back and pulling their data was the same
Outcomes Registry consent form that plaintiff signed in this
24 Allison Curtis testified that she was the global marketing
manager for annuloplasty rings for Edwards in 2006, and that
she was Dr. McCarthy's primary point of contact with
Edwards. She confirmed that there was no interaction between
Edwards and Dr. McCarthy during the regulatory phase of
developing the Myxo ring and that she did not discuss the
regulatory status of the ring with Dr. McCarthy at any time.
She did not describe the available pathways to market or
discuss the regulatory pathway that Edwards planned to take
with the Myxo ring with Dr. McCarthy. Edwards has very large
departments of experts that do nothing but FDA filing and
interfacing with the FDA. The ring was made available to Dr.
McCarthy in March 2006, after it had gone through the
regulatory process. It is customary, and an FDA requirement,
for Edwards to place large print labeling on investigational
products that says, "For Investigational Use Only."
The Myxo ring was never labeled or packaged as
"investigational" at any point in time, and nothing
about the marketing or handling of the ring by Edwards
suggested it was investigational. Ms. Curtis never told Dr.
McCarthy that it was investigational. Edwards never
considered the Myxo ring to be investigational.
25 Susan Gamble, Senior Director of Regulatory Affairs for
the heart valve therapy division at Edwards also testified at
trial. She explained how the "Justification to
File" (JTF) pathway to market a product works.
26 The FDA has prescribed pathways for the marketing of Class
II medical devices, including annuloplasty rings, when the
device is a minor modification of a substantially equivalent
device previously cleared or approved by the FDA. The FDA
guidelines, specifically the 1997 guidance document entitled
"Deciding When to Submit a 510(k) for a Change to an
Existing Device," provides that a device which
constitutes a minor modification to a device or devices
previously cleared by the FDA can be marketed after the
manufacturer has completed a comprehensive evaluation of the
device as prescribed by the guidance document.
27 Ms. Gamble testified that, with regard to the Myxo ring,
Edwards complied with the guidance document and completed the
JTF process on February 27, 2006. The JTF remains in the
records of a device manufacturer so it is available for
inspection by the FDA.
28 Ms. Gamble clarified that annuloplasty rings are not
"approved" by the FDA, but are "cleared."
If a JTF is utilized, there is no requirement that Edwards do
anything to tell the FDA it is distributing or marketing the
device. It was Ms. Gamble who made the decision regarding the
regulatory pathway of the Myxo ring, with the agreement of
her senior management. Edwards never considered the Myxo ring
to be an investigational product, and it never was an
investigational product. Ms Gamble confirmed that Edwards did
not involve Dr. McCarthy in the regulatory pathway
discussion, and did not talk to Dr. McCarthy about their
decision to proceed with the JTF.
29 Jeffrey Cooper, M.D., testified as a retained expert at
trial on behalf of defendants. He is a board-certified
physician in Pediatrics and Nuclear Medicine who has also
conducted medical research, served as a clinical investigator
for industry-sponsored medical research, and served on IRBs
and as chairman of an IRB. He is a founder and authored the
standards for the Association for the Accreditation of Human
Research Protection Programs (AAHRPP), a nonprofit
organization that reviews and accredits institutions that
conduct human research, including hospital or universities
that have IRBs.
30 Dr. Cooper explained that not all medical research is
regulated by the federal government. A "clinical
trial" has an investigator who is testing and comparing
specific devices or drugs. A characteristic of a clinical
trial is that there is a protocol, and the protocol mandates
what procedures are done and what care is going to be
administered. In a device clinical trial, the protocol will
determine which device a patient receives. Two devices will
be used, and the device that is used with a given patient is
assigned randomly. In a non-clinical trial, the care is
determined by the treating physician. No protocol mandates
the use of any particular medical procedure, drug, or device
in terms of treatment. When an investigator collects and
analyzes specimens or data, that is not a clinical trial. It
is also not a clinical trial when the care for each patient
is determined by the treating physician, data is collected
from patients who have a particular procedure, and the
investigator analyzes the data after the fact to see which
treatments worked best for which patients. In clinical care,
each decision is made for the individual patient, and the
actions taken are always for the benefit of the patient.
31 Dr. Cooper opined that, under FDA regulations, plaintiff
was not a human subject involved in a clinical investigation
when Dr. McCarthy utilized a Myxo ring in her surgery. Dr.
McCarthy implanted the Myxo ring because he felt that it was
the best treatment for her. Dr. McCarthy's use of the
Myxo ring was not based upon a protocol for evaluating the
safety or effectiveness of the device. Accordingly, Dr.
McCarthy was not a "clinical investigator" under
FDA regulations when he used the Myxo ring, and there was no
clinical investigation. Furthermore, under FDA regulations,
Dr. McCarthy was not required to treat the Myxo ring as an
investigational device. Therefore, Dr. Cooper stated that Dr.
McCarthy was not required to obtain research consent under
FDA or IRB requirements before he implanted the Myxo ring in
32 Dr. Cooper also opined that Dr. McCarthy complied with the
standard of care when he assumed that the Myxo ring he
implanted in plaintiff was legally marketed and cleared by
the FDA, because if a manufacturer wishes to have someone use
an unapproved device in a clinical investigation, the
manufacturer has certain responsibilities that are clearly
outlined by the FDA. The manufacturer is obligated to inform
the physician that it is an investigational device, which has
an IDE, and provide a proposed protocol for the use of the
device, along with a proposed consent. The manufacturer must
obtain a signed agreement of how the study is to be conducted
from the institution where the study is to be conducted. It
must make sure that the physician obtains IRB review of the
protocol and the consent, prominently label the device as
"investigational," and it cannot charge for an
investigational device. Edwards did not do any of these
things with the Myxo ring. Edwards treated the Myxo ring as
an FDA cleared device, because they believed it was cleared
pursuant to FDA guidelines. Furthermore, Dr. Cooper stated
that the standard of care did not require Dr. McCarthy to
investigate whether the Myxo ring had been cleared by the FDA
before he used it.
33 Dr. Cooper also opined that a physician may study any data
pertaining to any clinical care listed in the Outcomes
Registry, including devices or drugs, and that
plaintiff's consent to include her clinical data in the
Outcomes Registry had nothing to do with the use of the Myxo
ring during her surgery.
34 Plaintiff called Bruce Barkalow, Ph.D., as an expert
witness on FDA matters and medical devices. He acknowledged
that he was neither a physician, nor an expert on anatomy,
the mitral valve, mitral valve rings, or surgical techniques.
Dr. Barkalow opined that Edwards did not secure proper
clearance under FDA procedures to market the Myxo ring before
it was used on plaintiff. Dr. Barkalow conceded, however,
that it would not surprise him that a physician would defer
to a manufacturer as to what is required for FDA clearance.
He would expect Dr. McCarthy to rely upon lawyers and FDA
experts within Edwards to make that determination. He also
acknowledged that it is not unusual for a study using data
from a registry to be conducted even after a device has been
cleared by the FDA and marketed.
35 Plaintiff also called Nalini Rajamannan, M.D., as an
expert witness. Dr. Rajamannan had previously been employed
by NMFF and had previously worked with Dr. McCarthy. Dr.
Rajamannan's opinion was that Dr. McCarthy was conducting
a clinical trial on the Myxo ring without IRB approval and
that he was obligated to obtain IRB-approved consent from
plaintiff before implanting the Myxo ring, because it was an
investigational device. She opined that "Dr. McCarthy
violated the standard of care in regard to his failure to ***
obtain informed consent [from plaintiff] on his Myxo ring
study." Dr. Rajamannan also testified regarding her
theories as how the Myxo ring posed risks not posed by other
rings. Dr. Rajamannan believed that one of two possibilities
occurred during plaintiff's surgery. Specifically, either
the triangular shape of the Myxo ring caused narrowing in the
artery, or a suture was placed through the artery causing an
obstruction. She acknowledged however, that the risk from
suturing was not unique to the Myxo ring, and was present for
all annuloplasty rings used in mitral or valve repair
36 On cross-examination, Dr. Rajamannan acknowledged that she
did not complete a surgical residency or cardiac surgery
fellowship. She had also never performed cardiac surgery, or
assisted with surgery. She had never worked in an IRB office,
and she had never served as an IRB chair, manager, staff
member or committee member. Dr. Rajamannan had never made an
official determination on behalf of an IRB about whether an
activity constituted research.
37 When asked whether she had been suspended from NMFF in
October 2008, Dr. Rajamannan stated, "It was a blessing,
yes, I was suspended." She testified that she first
raised allegations regarding her concerns about the FDA
status of the Myxo ring with legal counsel for NMFF in July
of 2007. She testified that she raised concerns that the
study was being conducted without an "IDE" or
"IRB." In October of 2007, the people in the NMFF
legal department and risk management invited Dr. Rajamannan
to review the results and details of their investigation into
her allegations, but Dr. Rajamannan declined to meet with
38 Dr. Rajamannan also testified that she reported Dr.
McCarthy to the Illinois Department of Professional
Regulation, alleging that he "implanted an
investigational device in [plaintiff] knowing that it was
investigational or experimental." Additionally, Dr.
Rajamannan submitted a qui tam action in the United
States District Court to the Northern District of Illinois
asserting the same allegations, and she admitted that the
purpose of the action was "to obtain monetary
damages." She also made the allegation that Dr. McCarthy
implanted an investigational device, knowing that it was
investigational, to the FDA.
39 In addition, Dr. Rajamannan reached out to various media
outlets and she wrote several internet blogs regarding her
allegations against Dr. McCarthy. Dr. Rajamannan also made
these allegations to various bodies of the United States
government, including the United States Senate Finance and
Judiciary Committee, and the President of the United States.
Dr. Rajamannan self-published 13 E-books on
Amazon.com regarding her allegations about the Myxo
ring. Dr. Rajamannan testified that she became involved in
plaintiff's case when plaintiff's counsel contacted
her after press reports came out regarding her allegations
against Dr. McCarthy.
40 Plaintiff testified that when she was in her twenties, she
was diagnosed with mitral valve prolapse, and since that
time, she saw her cardiologist, Dr. Silverman regularly to
monitor her health. Around 2005 or 2006, when plaintiff was
approximately 50 years old, she began feeling worse and she
visited Dr. Silverman to have an echocardiogram performed.
When she woke up from the echocardiogram, Dr. Silverman told
plaintiff that she was "going to have to get that
surgery." Plaintiff subsequently saw Dr. McCarthy, and
underwent surgery with him on November 6, 2006. On
cross-examination, plaintiff acknowledged that Dr. McCarthy
told her that a ring would be used to accomplish the mitral
41 After the close of evidence and during the jury
instruction hearing, counsel for plaintiff indicated that
plaintiff had chosen not to send Count IX, "Medical
Battery versus Dr. McCarthy, with [NMFF] and [NMH] via
agency" to the jury.
42 After deliberations, the jury returned verdicts finding
for defendants and against plaintiff on both of the remaining
two counts. On April 1, 2016, the trial court entered a
judgment on the verdicts for defendants. On January 30, 2017,
the trial court denied plaintiff's post-trial motion.
Plaintiff filed a timely notice of appeal on March 1, 2017.
43 In this court, plaintiff raises several issues.
Specifically, plaintiff contends that the circuit court erred
in dismissing four counts (Count V, "Strict Liability -
Dr. McCarthy as Agent of Edwards"; Count VI,
"Informed Consent" against NMH; Count VIII,
"Medical Battery" against NMH; and Count X,
"Battery" against Edwards), and in granting summary
judgment on another count (Count III, "Product Liability
- Negligence Failure to Warn or Instruct" against
Edwards) prior to trial. Plaintiff also argues that the
circuit court erred in barring the use of certain documents
at trial, finding them privileged under the Medical Studies
Act. Plaintiff further asserts that the court erred in
designating one of her witnesses-Dr. Rajamannan-as a Rule
213(f)(3) expert witness. Finally, plaintiff contends that
the court abused its discretion in allowing certain
cross-examination of Dr. Rajamannan, and in allowing Dr.
McCarthy to testify that he donated his proceeds from the
Myxo ring to the Chicago Food Depository.
44 As noted above, the circuit court granted defendants'
section 2-615 motions to dismiss as to several counts. A
motion to dismiss brought pursuant to section 2-615 of the
Code attacks the legal sufficiency of the complaint.
Vitro v. Mihelcic, 209 Ill.2d 76, 81 (2004). When
ruling on such a motion, the court must accept as true all
well-pleaded facts in the complaint, as well as any
reasonable inferences that may arise from them. Doe v.
Chicago Board of Education, 213 Ill.2d 19, 28 (2004).
However, a court cannot accept as true mere conclusions
unsupported by specific facts. Pooh-Bah Enterprises, Inc.
v. County of Cook, 232 Ill.2d 463, 473 (2009). A
complaint should be dismissed under section 2-615 only if it
is clearly apparent from the pleadings that no set of facts
can be proven that would entitle the plaintiff to recover.
Bajwa v. Metropolitan Life Insurance Co., 208 Ill.2d
414, 421 (2004). The critical inquiry is whether the
allegations of the complaint, when construed in the light
most favorable to the plaintiff, are sufficient to establish
a cause of action on which relief may be granted.
Sheffler v. Commonwealth Edison Co., 2011 IL 110166,
¶ 61. Our review of an order granting a section 2-615
motion to dismiss is de novo. Solaia Technology,
LLC v. Specialty Publishing Co., 221 Ill.2d 558, 579
45 Plaintiff asserts that the trial court erred in dismissing
four counts (Count V, "Strict Liability - Dr. McCarthy
as Agent of Edwards"; Count VI, "Informed
Consent" against NMH; Count VIII, "Medical
Battery" against NMH; and Count X, "Battery"
against Edwards). Because plaintiff's arguments regarding
Counts VI, VIII, and X are related, we will consider the
court's dismissal of those counts first.
46 Regarding Count VI, "Informed Consent" against
NMH, Count VIII, "Medical Battery" against NMH, and
Count X, "Battery" against Edwards, plaintiff
contends that these claims are "based on common
themes." Specifically, plaintiff alleged that the Myxo
ring did not have proper FDA clearance and was
investigational, and that Dr. McCarthy was conducting a
clinical study using the Myxo ring before it was properly
cleared by the FDA. Plaintiff claims she was entitled to know
that the Myxo ring was not properly cleared by the FDA and
that it was investigational, and that Dr. McCarthy was
utilizing the Myxo ring during her surgery as part of a study
he was conducting. Plaintiff claims that the failure to
provide her this information violated her right to informed
consent. Plaintiff further contends that the actions of NMH
and Edwards "indirectly cause[d]" ...