                                   2019 IL App (1st) 170553

                                                                            FOURTH DIVISION
                                                                            June 28, 2019

                                 No. 1-17-0553
______________________________________________________________________________

                    IN THE APPELLATE COURT OF ILLINOIS
                           FIRST JUDICIAL DISTRICT
______________________________________________________________________________

MAUREEN OBERMEIER,                                                      )     Appeal from
                                                                        )     the Circuit Court
     Plaintiff-Appellant,                                               )     of Cook County
                                                                        )
       v.                                                               )
                                                                        )     08 L 012426
NORTHWESTERN MEMORIAL HOSPITAL, NORTHWESTERN                            )
MEDICAL FACULTY FOUNDATION, PATRICK MCCARTHY,                           )     Honorable
M.D., and EDWARDS LIFESCIENCES, LLC,                                    )     James M. McGing and
                                                                        )     William E. Gomolinski,
     Defendants-Appellees.                                              )     Judges Presiding.

______________________________________________________________________________

         PRESIDING JUSTICE McBRIDE delivered the judgment of the court, with opinion.
         Justices Gordon and Reyes concurred in the judgment and opinion.

                                           OPINION

¶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
No. 1-17-0553


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 counts.

¶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 left ventricle.

¶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



                                                  2
No. 1-17-0553


which the mitral valve does not close properly. Plaintiff then underwent an echocardiogram

which confirmed the existence of that condition.

¶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.



                                                 3
No. 1-17-0553


¶ 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 using.

¶ 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



                                               4
No. 1-17-0553


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 device.

¶ 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.




                                                 5
No. 1-17-0553


¶ 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

investigational.

¶ 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

Unit.




                                                 6
No. 1-17-0553


¶ 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.



                                                 7
No. 1-17-0553


¶ 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 case.

¶ 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.



                                                  8
No. 1-17-0553


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.




                                                  9
No. 1-17-0553


¶ 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



                                                 10
No. 1-17-0553


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

plaintiff.

¶ 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



                                                  11
No. 1-17-0553


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.




                                               12
No. 1-17-0553


¶ 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 surgery.

¶ 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




                                                13
No. 1-17-0553


risk management invited Dr. Rajamannan to review the results and details of their investigation

into her allegations, but Dr. Rajamannan declined to meet with them.

¶ 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




                                                 14
No. 1-17-0553


November 6, 2006. On cross-examination, plaintiff acknowledged that Dr. McCarthy told her

that a ring would be used to accomplish the mitral valve repair.

¶ 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



                                                  15
No. 1-17-0553


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 (2006).

¶ 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



                                               16
No. 1-17-0553


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]” plaintiff to come into contact with the Myxo ring, in a manner

“reasonably regarded as offensive” and “without consent or at substantial variance with the

consent she gave.”

¶ 47   The trial court allowed plaintiff’s informed consent and battery claims to go forward

against Dr. McCarthy, but found that those claims could not be brought directly against the

hospital or Edwards. Accordingly, the trial court dismissed the institutional informed consent and

battery claims against NMH (Counts VI and VIII, respectively), and the battery claim against

Edwards (Count X).

¶ 48   As an initial matter, we point out that plaintiff’s claims against Dr. McCarthy—and

against NMH and NMFF via respondeat superior—were tried before a jury, which found in

favor of defendants. In this appeal, plaintiff does not argue that any aspect of the jury verdicts

was against the manifest weight of the evidence, or otherwise challenge the jury verdicts in any

way.

¶ 49   The jury in this case heard the evidence presented by plaintiff—and contested by

defendants—that the Myxo ring was investigational, that she was not informed that Dr.

McCarthy would be utilizing an investigational device, that the Myxo ring caused her injury, and

that Dr. McCarthy was improperly conducting a clinical study of the Myxo ring. The jury also

heard conflicting evidence from the parties that the consent given by plaintiff was inadequate,

and that had she known of the Myxo ring’s investigational nature, she would not have consented




                                               17
No. 1-17-0553


to its use. Following the close of evidence, the jury rejected plaintiff’s claims, and rendered

verdicts in favor of defendants.

¶ 50   In this appeal, plaintiff seeks to have the dismissals and summary judgment of certain

counts reversed, so that she can return to the trial court and try those counts against NMH and

Edwards. However, it is clear from plaintiff’s description of the “themes” underlying those

issues, that the theories on which those counts are based are substantially the same as the theories

already rejected by the jury. In these circumstances, a relitigation of the issues against NMH and

Edwards is precluded by estoppel by verdict, which prohibits a party from pursuing a claim again

that raises factual issues identical to those already decided by a jury. Franciscy v. Jordan, 43 Ill.

App. 2d 344, 351 (1963).

                “When some specific fact or question has been actually and directly in issue and

                has been adjudicated by a Court of competent jurisdiction in a former suit, and the

                same fact or question is again put in issue in a subsequent suit between parties or

                their privities who were parties in the former suit, its determination in the former

                suit, if properly presented and relied upon, is conclusive upon the parties and their

                privities in the latter suit, without regard to whether or not the cause of action is

                the same in both suits, and it cannot be again litigated in the subsequent suit upon

                the same or a different cause of action whatever may have been the nature of the

                first action or of the second action in which the estoppel is set up.” Id.

¶ 51   In this case, the jury returned general verdicts in favor of defendants, and plaintiff did not

request that the jury be given any special interrogatories. “When there is a general verdict and

more than one theory is presented, the verdict will be upheld if there was sufficient evidence to

sustain either theory, and the [moving party], having failed to request special interrogatories,



                                                  18
No. 1-17-0553


cannot complain.” Lazenby v. Mark’s Construction, Inc., 236 Ill. 2d 83, 101 (2010). A “general

verdict rendered by the jury creates a presumption that the jury found in favor of [a defendant]

on every defense raised” (id. at 102), as well as a presumption that “all issues of fact upon which

proof was offered were found in favor of the prevailing party” (Holloway v. Sprinkmann Sons

Corp. of Illinois, 2014 IL App (4th) 131118, ¶ 143). Accordingly, we must presume that the jury

found against plaintiff on every issue raised in the counts that were before it. In particular,

defendants would be entitled to a presumption that the jury rejected plaintiff’s claims that the

Myxo ring was investigational, that it caused her injury, and that she did not give proper

informed consent.

¶ 52   Nevertheless, even if we were to conclude that estoppel by verdict does not preclude

plaintiff’s claims, we would still conclude that they fail for the reasons that follow.

¶ 53   First, as to Count VI, “Informed Consent” against NMH, Illinois courts have held that,

unlike a physician, a hospital generally has no duty to obtain informed consent from a patient.

Kus v. Sherman Hospital, 268 Ill. App. 3d 771, 780 (1995). “The rationale underlying this rule is

that the physician has the technical knowledge and training necessary to advise each patient of

the risks, and that the hospital does not know the patient’s medical history, nor the details of the

particular surgery to be performed.” (Internal quotation marks omitted). Id.; see also Lenahan v.

University of Chicago, 348 Ill. App. 3d 155, 161 (2004).

¶ 54   Plaintiff acknowledges the general rule, but cites to Kus, 268 Ill. App. 3d at 779, and

Lenahan, 348 Ill. App. 3d at 161, as situations in which a hospital may be liable for failing to

obtain informed consent from a patient.

¶ 55   In Kus, 268 Ill. App. 3d 771, the plaintiff received an intraocular lens implant during

cataract surgery. The lens that was used in the surgery was under investigation for safety and



                                                 19
No. 1-17-0553


effectiveness by the FDA, and the hospital was involved in a monitored clinical study for the

implantation of intraocular lens. The implantation of intraocular lens into human subjects was

permitted only under the Medical Device Amendments of 1976 exemption for experimental

devices (see generally 21 U.S.C. § 301, et seq. (1988)), and pursuant to federal regulations, the

hospital’s IRB was charged with the responsibility of assuring that “legally effective informed

consent [was] obtained.” Kus, 268 Ill. App. 3d at 773. Moreover, the federal regulations

mandated that certain disclosures be provided to patients involved in the study. Despite the fact

that there was a mandated FDA-approved consent form, the physician modified that form,

removing a paragraph labeled “clinical investigation,” which was intended to inform the patient

that the lens was under investigation for safety and efficacy. Id. at 774.

¶ 56   The court in Kus initially reiterated the general rule that a hospital has no duty to obtain

informed consent from a patient, but found in the circumstances before it that the hospital

specifically undertook an obligation to assure that informed consent was obtained.

                “By becoming a participating institution in this particular study, Sherman

                Hospital was charged with assuring that ‘legally effective informed consent’ was

                obtained prior to the experimental surgery (21 C.F.R. § 813.66(a)(6) (1993)) and

                that ‘procedures which are experimental’ needed to be identified before such

                surgery occurred. (21 C.F.R. § 50.25(a)(1) (1993).) While we agree that generally

                a hospital is not in the best position to inform a patient of risks, here it is clear that

                Sherman Hospital undertook the responsibility to inform the plaintiff of the

                experimental nature of his surgery. Moreover, a participating institution in the

                intraocular lens study is required to conduct ‘continuing review of research’ under

                the Federal guidelines, which includes the duty to review the informed consent



                                                   20
No. 1-17-0553


                process (21 C.F.R. § 56.109 (1993)). Thus, Sherman Hospital also had the

                minimal duty here of checking to ensure that the form its IRB had promulgated

                was being used. We determine that the particular facts in the case before us

                require a determination that a hospital, as well as a physician, may be liable for

                claims arising from the lack of informed consent in this instance.” Id. at 780-81.

¶ 57   Similarly, in Lenahan, the appellate court reversed the trial court’s dismissal of an

institutional informed consent claim against a hospital. In that case, a cancer patient participated

in a phase I clinical trial, and he died during the course of the clinical trial. Lenahan, 348 Ill.

App. 3d at 158. The plaintiff, his mother, alleged institutional negligence against the hospital,

based on its failure to obtain adequate informed consent to participate in the clinical trial. The

plaintiff alleged that her son’s death was caused by his participation in the clinical trial, and that

the hospital “negligently fail[ed] to disclose in the decedent’s consent form all the risks and

alternatives to treatment.” Id. at 160. The plaintiff specifically alleged that the hospital was a

signatory to a policy stating that it bore an “independent institutional responsibility to obtain

informed consent from all human subjects in the clinical trial, and that such informed consents

must comply with applicable [FDA] and Department of Health and Human Services (DHHS)

rules and regulations as set forth in Titles 21 and 45 of the Code of Federal Regulations (CFR).”

Id. Pursuant to this policy, the University and Hospital formed an IRB to ensure that the consent

forms complied with the FDA and DHHS regulations.

¶ 58   The Lenahan court also noted the general rule, but relied on Kus to conclude that the

hospital could be held liable where it “adopted policies and established an IRB to ensure that the

consent forms complied with the applicable FDA and DHHS regulations.” Id. at 161.




                                                 21
No. 1-17-0553


¶ 59   As these cases illustrate, there is an exception to the general rule that physicians, not

hospitals, are responsible for obtaining informed consent from patients in cases of experimental

surgery or a clinical trial, where the hospital specifically undertakes an obligation to ensure the

patient’s informed consent.

¶ 60   Kus and Lenahan, however, are distinguishable from the instant case. Neither Dr.

McCarthy nor NMH believed the Myxo ring to be an investigational device. Edwards, the device

manufacturer, also did not believe the Myxo ring to be investigational, and did not classify it as

such. Accordingly, NMH did not undertake a specific obligation to obtain informed consent from

Dr. McCarthy’s patients to conduct a clinical trial. In these circumstances, we find no facts

which would support a deviation from the general rule, and therefore, a dismissal of Count VI,

“Informed Consent” against NMH was proper.

¶ 61   We next turn to Count VIII, “Medical Battery” against NMH, and Count X, “Battery”

against Edwards.

¶ 62   The elements of a claim for civil battery are: (1) an intentional act on the part of the

defendant, (2) resulting in offensive contact with the plaintiff’s person, and (3) lack of consent to

the defendant’s conduct. McNeil v. Brewer, 304 Ill. App. 3d 1050, 1055 (1999). Specifically, a

plaintiff claiming medical battery must establish one of the following: (1) no consent to the

medical procedure performed; (2) the procedure was contrary to the injured party’s will; or (3)

substantial variance of the procedure from the consent granted. Holzrichter v. Yorath, 2013 IL

App (1st) 110287, ¶ 83; Fiala v. Bickford Senior Living Group, LLC, 2015 IL App (2d) 150067,

¶ 26 (citing McDonald v. Lipov, 2014 IL App (2d) 130401, ¶ 20). Under any of these

circumstances, a battery has occurred, because the person administering the medical treatment

touched the person of another without authorization. Id. The lack of consent to the medical



                                                 22
No. 1-17-0553


treatment is the focus, not the intent of the person administering the medical treatment, and “the

law maintains a distinction between a total lack of consent (battery) and a lack of informed

consent (negligence).” Id.; see also Mink v. University of Chicago, 460 F. Supp. 713, 717 (N.D.

Ill. 1978) (“battery may be the proper cause of action in certain situations, for example, where

there is a total lack of consent by the patient.”).

¶ 63    Plaintiff generally contends that her complaint adequately alleged that NMH “intended to

indirectly cause [her] to come into contact with a foreign substance (the Myxo ring) in a manner

which is reasonably regarded as offensive, and in a manner which was without consent or at

substantial variance with the consent she gave.” (Emphasis omitted).

¶ 64    Here, it is undisputed that plaintiff consented to Dr. McCarthy’s performance of a mitral

valve surgery on her. Further, she acknowledged that Dr. McCarthy specifically informed her

that a ring would be used to accomplish the mitral valve repair. Moreover, the evidence showed

that the decision as to which particular annuloplasty ring was used could not be made until

surgery was underway. These circumstances do not support the “total lack of consent” necessary

to maintain a claim of medical battery.

¶ 65    Plaintiff relies on Mink, 460 F. Supp. 713 (N.D. Ill. 1978), for her conclusion that the

dismissal of her battery claim against NMH was improper. In Mink, the federal district court for

the Northern District of Illinois considered whether the administration of a drug to the plaintiffs

without their knowledge or consent constituted a battery under Illinois law. Id. at 716. The

plaintiffs in Mink were approximately 1000 women who were given a drug as part of a medical

experiment conducted by the defendants, University of Chicago and Eli Lilly & Company

between 1950 and 1952. Id. at 715. The drug was administered to the plaintiffs during their

prenatal care as part of a double blind study. The women were not told they were part of an



                                                      23
No. 1-17-0553


experiment, nor were they told that they were being administered a drug. Id. The plaintiffs

claimed that as a result of their taking the drug, their children developed various medical issues

including an increased risk of cancer. Id.

¶ 66   The court initially explained the difference between battery claims, and negligence claims

of a lack of informed consent, noting that both were cognizable under Illinois law but that each

applied in different situations. Id. at 716-17. The court then defined the issue as “whether the

instant case is more akin to the performance of an unauthorized operation than to the failure to

disclose the potential ramifications of an agreed to treatment,” ultimately concluding that the

circumstances of that case were “closer to the former.” Id. at 717. The court pointed out that the

plaintiffs did not consent to the drug, and were not even aware that the drug was being

administered to them. Id. Accordingly, they were the subjects “of an experiment whereby non­

emergency treatment was performed upon them without their consent or knowledge.” Id.

¶ 67   Here, the record shows that plaintiff consented to the mitral valve surgery that Dr.

McCarthy’s performed on her, and was aware that a ring would be utilized as part of that

surgery. Although plaintiff may not have been aware of the particular type of annuloplasty ring

that would be used—indeed, the record shows that a choice of ring could not be made until

surgery was underway and plaintiff was under anesthesia—the plaintiff’s lack of consent to the

use of a particular annuloplasty ring cannot be said to be “akin to the performance of an

unauthorized operation.” Id. In these circumstances, we find no error in the trial court’s dismissal

of the battery claim against NMH.

¶ 68   Specifically as to plaintiff’s battery claim against Edwards, plaintiff contends that

Edwards’ “role in the distribution of the ring *** makes it complicit in the civil battery.” She

claims that her battery count alleges that Edwards “bore the direct responsibility for registering



                                                24
No. 1-17-0553


the Myxo ring with the FDA and for ensuring that it was properly cleared or approved by the

FDA,” but that it did not do so. Plaintiff’s theory, therefore, is that Edwards failed to proceed

through the proper regulatory pathway, ensuring that the Myxo ring was properly cleared by the

FDA. This claim, however, is precluded by the Food, Drug, and Cosmetic Act (FDCA), which

provides that such alleged violations are the exclusive domain of the FDA. See 21 USC § 337(a)

(West 2016) (“all such proceedings for the enforcement, or to restrain violations, of this chapter

shall be by and in the name of the United States.”); see also Buckman Co. v. Plaintiffs’ Legal

Committee, 531 U.S. 341, 348 (2001) (holding that the plaintiffs’ state-law claims were pre­

empted by the FDCA).

¶ 69   Even if plaintiff could prove that Edwards failed to comply with FDA regulations,

plaintiff is unable to recover from Edwards for this failure alone. The United States Supreme

Court has conclusively determined that a private litigant may not sue a medical-device

manufacturer for violating the FDCA. Buckman Co., 531 U.S. 341, 349 n. 4 (2001) (“The FDCA

leaves no doubt that it is the Federal Government rather than private litigants who are authorized

to file suit for noncompliance with the medical device provisions”); see also Martin v. Ortho

Pharmaceutical Corp., 169 Ill. 2d 234, 241 (1996) (affirming summary judgment in favor of

drug manufacturer where the plaintiffs sought “to premise a private cause of action in State court

upon defendant’s alleged violation of [FDA regulations].”). In these circumstances, we conclude

that plaintiff’s battery claim against Edwards is preempted by the FDCA, and accordingly, that it

was properly dismissed.

¶ 70   Plaintiff also asserts that the trial court erroneously dismissed Count V, “Strict Liability –

Dr. McCarthy as Agent of Edwards.” Plaintiff specifically alleges that she properly pleaded the

following facts to support an agency claim against Edwards—“that Dr. McCarthy served as



                                                25
No. 1-17-0553


Edwards’ paid consultant,” “that he invented the Myxo ring” and that he “was directly involved

in the design and the marketing and promotion of the ring, as Edwards’ paid agent.”

¶ 71   As an initial matter, it is unclear to this court the import of a dismissal of plaintiff’s

agency claim against Edwards, alleging that Dr. McCarthy was an agent of Edwards, since the

jury found in favor of Dr. McCarthy on all counts. Even assuming an agency relationship, there

is no conduct of Dr. McCarthy from which Edwards could be liable as a principal. See Wilson v.

Edward Hospital, 2012 IL 112898, ¶ 24 (“actual agency and apparent agency are not causes of

action” but instead are “merely part of the duty analysis in a case where the plaintiff seeks to

hold the principal liable for the agent’s alleged negligence.”). Nevertheless, plaintiff’s claim fails

on the merits as well.

¶ 72   Where there exists an agency relationship, a principal may be held vicariously liable for

the wrong-doing of its agent. Anderson v. Boy Scouts of America, Inc., 226 Ill. App. 3d 440, 443

(1992). The test of agency is whether the alleged principal has the right to control the manner

and method in which work is carried out by the alleged agent and whether the alleged agent can

affect the legal relationships of the principal. Id. The question of whether a principal-agency

relationship existed is generally one of fact, but it becomes one of law where the evidence is not

disputed. Id. at 444. The burden of proving the existence of an agency relationship and the scope

of authority is on the party seeking to charge the alleged principal. Id.

¶ 73   Here, the facts alleged by plaintiff to establish an agency relationship are essentially that

Dr. McCarthy invented the Myxo ring, which was manufactured by Edwards, and that Edwards

paid him. Such facts are insufficient to show that Edwards controlled Dr. McCarthy in his

manner and method of work, and accordingly, are insufficient to support a claim of actual

agency.



                                                 26
No. 1-17-0553


¶ 74   In support of her claim that the dismissal of her agency claim was improper, plaintiff

cites HPI Health Care Services, Inc. v. Mt. Vernon Hospital, Inc., 172 Ill. App. 3d 718, 732-35

(1988), in which the fifth district appellate court concluded that the plaintiff’s claim based on

agency was improperly dismissed. In so holding, the court held that although the inferences

raised from the pleadings might be subject to debate, the rule in Illinois is that unless the parties’

relationship is so clear as to be undisputed, the existence and scope of an agency relationship are

questions of fact to be determined by the trier of fact. Plaintiff compares the circumstances of her

case to the circumstances in HPI Health Care Services, Inc., to contend that she adequately

pleaded her claim, and that the dismissal of the agency claim should be reversed.

¶ 75   Plaintiff, however, neglects to point out that HPI Health Care Services, Inc., 172 Ill. App.

3d 718, was appealed to the supreme court, which reversed the appellate court’s decision on

agency, holding that the principle cited by the appellate court “does not free the plaintiff of his

obligation to allege specific facts in support of his claim” and “the plaintiff must still allege

specific facts regarding the circumstances of the situation from which the existence of the

relationship can be inferred.” HPI Health Care Services, Inc. v Mt. Vernon Hospital, Inc., 131

Ill. 2d 145, 163 (1989). The supreme court ultimately held that the plaintiff “failed to provide

any specific allegations of fact that would give rise to an inference [of an agency relationship].”

Id.

¶ 76   Moreover, to establish apparent agency, the party alleging the existence of the agency

relationship must prove that (1) the principal or its agent acted in a manner that would lead a

reasonable person to believe that the individual allegedly at fault was an employee or agent of

the principal; (2) the principal had knowledge of and acquiesced in the acts of the agent; and (3)

the injured party acted in reliance upon the conduct of the principal or its agent, consistent with



                                                 27
No. 1-17-0553


ordinary care and prudence. Thomas v. Weatherguard Construction Co., 2015 IL App (1st)

142785, ¶ 49 (citing Wilson v. Edward Hospital, 2012 IL 112898, ¶ 18).

¶ 77   In this case, Plaintiff never alleged any facts that would tend to show that she acted in

reliance upon Dr. McCarthy’s apparent authority as an agent of Edwards. In fact, as the

complaint suggests and the record shows, plaintiff did not know that Dr. McCarthy would use

the Myxo ring manufactured by Edwards during her heart surgery. In these circumstances,

plaintiff’s agency claim fails and we find no error on the part of the trial court in dismissing it.

¶ 78   Plaintiff next contends that the circuit court erred in granting summary judgment on

Count III, “Product Liability – Negligence Failure to Warn or Instruct” against Edwards.

¶ 79   Summary judgment is proper when the pleadings, depositions, and admissions on file,

together with the affidavits, if any, show that there is no genuine issue as to any material fact and

that the moving party is entitled to a judgment as a matter of law. Nationwide Financial, LP v.

Pobuda, 2014 IL 116717, ¶ 25. We review summary judgment orders de novo. Id. (citing Schultz

v. Illinois Farmers Insurance Co., 237 Ill. 2d 391, 399-400 (2010).

¶ 80   Plaintiff contends that this count “is not a classic failure to warn products liability case”

acknowledging that she does not “allege that the Myxo ring was defective.” Instead, plaintiff

contends that “[s]ince the product was in development and being studied,” Edwards was

negligent in failing to “ensure that patients were given all pertinent information so the patients

could, in turn, give proper informed consents.” Plaintiff relies on Dr. Barkalow’s testimony to

show that Edwards “did not properly follow the rules involving a JTF which renders Edwards’

JTFs invalid” and “that the pathway Edwards took to market this device produced a lack of

informed consent.” Accordingly, plaintiff asserts that “genuine issues of material fact exist[] in




                                                  28
No. 1-17-0553


this case as to whether the Myxo ring was investigational, and whether Edwards improperly cut

regulatory corners to hastily place the Myxo ring into use by Dr. McCarthy for use in the study.”

¶ 81   Like plaintiff’s battery claim described above, plaintiff’s “failure to warn” claim, is also

premised on Edwards’s alleged violations of the FDA and its alleged failure to proceed through

proper regulatory channels. Plaintiff’s argument appears to be that, regardless of whether the

Myxo ring was defective in any way, Edwards had a duty to warn patients that it had not been

properly cleared by the FDA. To allow plaintiff to recover on her failure to warn claim without

any allegation that the Myxo ring was defective would amount to creating a cause of action for a

violation of the FDCA, which, as described above, is precluded under Buckman, 531 U.S. 341,

349 n. 4 (2001).

¶ 82   Plaintiff next argues that the trial court erred in finding particular documents privileged

under the Medical Studies Act (MSA), and barring their use at trial. Plaintiff contends that a

“central issue in this case is whether Dr. McCarthy implanted his new Myxo ring on patients as

part of a study which required the informed consent of his patients.” Plaintiff points to an article

authored by Dr. McCarthy regarding the Myxo ring, and states that the article “gave rise to a

series of questions,” namely, whether the Northwestern IRB allowed a study of the Myxo ring;

whether, when getting consent to include their information in the Outcomes Registry, patients

were told that “Dr. McCarthy intended to use his new Myxo ring”; and whether Dr. McCarthy

informed patients that he “intended to implant a new annuloplasty ring with new features, or that

it was larger than other customary rings.” The particular documents that plaintiff sought to use,

and which are at issue in this appeal are the following—“Protocols,” a “New Project Submission

Form,” and a “Request to Waive Consent.” These documents were apparently inadvertently

produced to plaintiff by NMH, before Northwestern University, who was not a party at trial or in



                                                29
No. 1-17-0553


this appeal, objected to their disclosure and use in the court proceedings. Plaintiff contends that

she seeks to use these documents to “show that [the] IRB *** did not authorize Dr. McCarthy to

study the Myxo ring.”

¶ 83   The record shows that on December 6, 2013, the parties appeared, along with counsel

representing two Northwestern University employees who had upcoming depositions, for

hearing on whether the above documents were privileged under the MSA. After argument

regarding the applicability of particular case law, the court stated:

                “I’m going to hold that it is MSA. I’m going to say you can’t use the protocol.

                *** [S]o what I found to be MSA privileged are [the ‘Protocols,’ the ‘New

                Project Submission Form,’ and the ‘Request to Waive Consent.’]”

¶ 84   As an initial matter, in this court the Northwestern defendants contend that plaintiff’s

claim must be rejected because she “submitted [it] against the wrong entity.” The Northwestern

defendants point out that it was Northwestern University who invoked the MSA in the circuit

court and obtained the order to which plaintiff now objects. Northwestern University, however,

was not a party to the trial court proceedings, and it is not a party to this appeal. Accordingly, the

Northwestern defendants contend that “[p]laintiff’s requested review of [Northwestern

University]’s assertion of the MSA privilege is not properly levied against Defendants-Appellees

NMH and NMFF in this appeal.” The Northwestern defendants contend that they “cannot now

take the place of NU in asserting a privilege that they did not advocate for in the lower court and

does not belong to them to assert.”

¶ 85   Plaintiff replies that all the Northwestern entities, including Northwestern University,

were, and are, represented by the same law firm. Accordingly, plaintiff contends that the




                                                 30
No. 1-17-0553


“Northwestern lawyers were served with the Notice of Appeal *** [and] could have appeared for

the University had they wished to do so.”

¶ 86   We conclude that we need not determine whether plaintiff’s failure to include

Northwestern University in this appeal is fatal to her claim, because it fails on the merits.

¶ 87   The MSA provides, in relevant part, that:

                “All information, interviews, reports, statements, memoranda, *** or other data of

                *** allied medical societies, health maintenance organizations, medical

                organizations under contract with health maintenance organizations or with

                insurance or other health care delivery entities or facilities, *** or committees of

                licensed or accredited hospitals or their medical staffs, including Patient Care

                Audit Committees, Medical Care Evaluation Committees, Utilization Review

                Committees, Credential Committees and Executive Committees, or their

                designees (but not the medical records pertaining to the patient), used in the

                course of internal quality control or of medical study for the purpose of reducing

                morbidity or mortality, or for improving patient care or increasing organ and

                tissue donation, shall be privileged, strictly confidential and shall be used only for

                medical research, increasing organ and tissue donation, the evaluation and

                improvement of quality care, or granting, limiting or revoking staff privileges or

                agreements for services[.]” (Emphasis added). 735 ILCS 5/8-2101 (West 2016).

¶ 88   The MSA further provides that any

                “[s]uch information, records, reports, statements, notes, memoranda, or other data,

                shall not be admissible as evidence, nor discoverable in any action of any kind in

                any court or before any tribunal, board, agency or person. The disclosure of any



                                                 31
No. 1-17-0553


                such information or data, whether proper, or improper, shall not waive or have

                any effect upon its confidentiality, nondiscoverability, or nonadmissibility.”

                (Emphasis added). 735 ILCS 5/8-2102 (West 2016).

¶ 89   The purpose of the MSA is “to encourage candid and voluntary studies and programs

used to improve hospital conditions and patient care or to reduce the rates of death and disease.”

Niven v. Siqueira, 109 Ill. 2d 357, 366 (1985). Our supreme court has explained that to promote

these goals “the legislature provided that any materials used in such studies or programs shall be

confidential.” Id.

¶ 90   Whether a discovery privilege applies is a matter of law, subject to de novo review. Webb

v. Mount Sinai Hospital & Medical Center of Chicago, Inc., 347 Ill. App. 3d 817, 825 (2004).

However, “whether specific materials are part of an internal quality control or a medical study is

a factual determination, which will not be reversed on review unless it is against the manifest

weight of the evidence.” Anderson v. Rush-Copley Medical Center, Inc., 385 Ill. App. 3d 167,

174 (2008).

¶ 91   Plaintiff does not challenge that the barred documents qualified as any “other data ***

used in the course of internal quality control or of medical study for the purpose of reducing

morbidity or mortality, or for improving patient care.” Plaintiff contends, however, that the

barred documents should have been admitted because allowing a privilege under the MSA here

is “inconsistent with the [MSA]’s purpose.”

¶ 92   This court addressed the applicability of the MSA to protocols submitted in advance of

medical studies in Doe v. Illinois Masonic Medical Center, 297 Ill. App. 3d 240, 243-45 (1998).

In Doe, the plaintiffs were parents who had given birth to child who suffered from cystic fibrosis

after participating in the hospital’s preimplantation genetic testing procedure. The plaintiffs



                                               32
No. 1-17-0553


brought medical malpractice claims against the doctors and hospital, and sought all protocols

submitted to the IRB for the study involving cystic fibrosis. In analyzing the plain language of

the MSA, the court determined that it was “clear that the [MSA] applies to the materials in

question,” and that the “IRB here qualifies as the type of committee covered by the Act.” Id. at

243-44. In so holding, the court noted that “[w]hile restrictions on discovery may make it

difficult in some instances, if not impossible, for plaintiffs to prove otherwise meritorious cases,

such restrictions nevertheless represent a considered judgment that interests of litigants must

yield to other interests, in this case confidentiality, privacy and candid peer review within

medical institutions.” Id. at 245.

¶ 93   Based on the above, and our review of the documents in question—which, as stated

above, were inadvertently disclosed, and are part of the record on appeal—it is clear that the

plain language of the MSA applies to the barred documents. In this case, the record shows that

plaintiff consented to participate in the Outcomes Registry, agreeing to provide her clinical data

for future study. Like in Doe, Dr. McCarthy’s outcome study protocol documents (including the

Protocols, “New Project Submission Form,” and “Request to Waive Consent”) were submitted to

the IRB for approval as part of the required protocol submission process. Accordingly, these

documents are subject to the privilege granted by the MSA, and we find no error in the court’s

exclusion of the documents. Id.

¶ 94   Nevertheless, even if we were to find that the court improperly barred the documents

described above, plaintiff’s claim would still fail, because she has not alleged or shown any

prejudice from the trial court’s exclusion of the named documents. See Riehl v. Riehl, 247 Ill.

475, 477 (1910) (“any error which may have been committed in rulings upon the admission or

exclusion of evidence is unimportant if there is competent evidence in the record sufficient to



                                                33
No. 1-17-0553


support the decree, and that the evidence which ought to have been considered would not, if

considered, change the result.”). Not every erroneous exclusion of evidence suffices to reverse a

judgment; instead, the relevant inquiry, on the review of a trial court’s exclusion of evidence, is

whether the trial court improperly excluded evidence so as to have deprived a party of a fair trial.

Pyskaty v. Oyama, 266 Ill. App. 3d 801, 814 (1994). An error in the admission or exclusion of

evidence will not constitute reversible error unless one party has been prejudiced or the

proceedings have been materially affected. Pister v. Matrix Service Industrial Contractors, Inc.,

2013 IL App (4th) 120781, ¶ 56.

¶ 95   Here, plaintiff concedes that she was able to utilize alternative evidence—namely,

witness testimony—to “make nearly the same point” as she would have made using the barred

documents. She contends, however, that this alternative evidence was insufficient because “ ‘a

picture’s worth a thousand words,’ ” and the witnesses’ “[m]ere words cannot substitute for [the

documents themselves].” Although the alternative evidence may not have been plaintiff’s

preferred evidence, given plaintiff’s concession, she cannot show that she was deprived of a fair

trial by her inability to use the barred documents. Pyskaty, 266 Ill. App. 3d at 814.

¶ 96   Plaintiff next asserts that the trial court erred in “designating Dr. Rajamannan as

plaintiff’s Rule 213(f)(3) witness.” Illinois Supreme Court Rule 213(f)(3) provides:

                (f) Identity and Testimony of Witnesses. Upon written interrogatory, a party must

                furnish the identities and addresses of witnesses who will testify at trial and must

                provide the following information:

                                                       ***

                   (3) Controlled Expert Witnesses. A “controlled expert witness” is a person

                   giving expert testimony who is the party, the party’s current employee, or the



                                                 34
No. 1-17-0553


                    party’s retained expert. For each controlled expert witness, the party must

                    identify: (i) the subject matter on which the witness will testify; (ii) the

                    conclusions and opinions of the witness and the bases therefor; (iii) the

                    qualifications of the witness; and (iv) any reports prepared by the witness

                    about the case.

¶ 97   The record shows that on May 10, 2013, the Northwestern defendants filed a motion to

deem Dr. Rajamannan a Rule 213(f)(3) witness, requesting that the doctor’s testimony be

“subject to all of the disclosure requirements of that rule,” and “not subject to the payment

requirements of Supreme Court Rule 204.” The Northwestern defendants complained that they

had been surprised by, and had been unable to adequately prepare for, Dr. Rajamannan’s two

prior depositions, because her testimony included various opinions, and relied on various

documents, that had not been previously disclosed. The Northwestern defendants pointed out that

Dr. Rajamannan only had a brief encounter with plaintiff while employed by Northwestern, and

the majority of the doctor’s anticipated testimony was related to that encounter. Instead, Dr.

Rajamannan reviewed various records provided by plaintiff in order to form her opinions for

trial. Although plaintiff was not paying Dr. Rajamannan, the Northwestern defendants asserted

that she should be classified as a Rule 213(f)(3) witness because plaintiff engaged Dr.

Rajamannan after discovering that she was critical of defendants, and plaintiff had

                “enjoyed full and continuous cooperation from her over an extended period of

                time. *** She is a witness whom Plaintiff engaged for the purpose of rendering an

                expert opinion at trial. She has fully cooperated with Plaintiff in researching his

                case, preparing his case, preparing her testimony in the case, and preparing

                exhibits for use at trial.”



                                                35
No. 1-17-0553


¶ 98   At the May 28, 2013, hearing on the Northwestern defendants’ motion, the Northwestern

defendants asked that plaintiff’s counsel be required to disclose and seasonably update her

opinions consistent with Rule 213(f)(3). The Northwestern defendants also pointed out that Dr.

Rajamannan was now seeking to be paid by the Northwestern defendants for her testimony as a

213(f)(2) witness.

¶ 99   At the hearing, plaintiff’s counsel acknowledged that Dr. Rajamannan “cooperated in

giving opinions that [we]re favorable to [plaintiff’s] case,” and that her testimony went beyond

her treatment of plaintiff, but contended that such cooperation did not rise to the level of being a

213(f)(3) witness. The court pointed out that case law indicated that if a physician sought to

“render opinion or give testimony that exceeds her treatment of this individual, then that would

be [213(f)(3)]. *** She’s now gone beyond that, and *** done animations and she’s given

opinions, and she’s *** read other articles about this and proffered opinion on standards of care.”

¶ 100 Plaintiff’s counsel ultimately agreed to provide disclosure pursuant to Rule 213(f)(3).

Counsel for plaintiff stated:

                “Counsel for the defense is right to have a concern about making sure that

                everything Rajamannan has to say at trial is aptly disclosed and duly disclosed. I

                think they’re entitled to full disclosure on anything Dr. Rajamannan has to say

                before she gets to trial under F3 rules no matter what we decide to call her. I think

                that’s fair. So if all we’re talking about here is disclosure and supplementing

                disclosure and making sure that nobody gets sandbagged with what Dr.

                Rajamannan has to say at trial, I have no problems with that, Judge. Fair is fair,

                and I think that’s fair. But I think the difficulty comes in, though, with her, how




                                                 36
No. 1-17-0553


                do you let them run from their own employee? They gave her a paycheck when

                she was doing this. She’s their employee.”

¶ 101 The court then stated:

                “I’m going to designate her an F3. I don’t do so lightly. I think this is a very

                different type of situation, one that the court has not [previously] come upon ***.

                And *** I’m guided by some of the prior cases that I’ve read that indicate if a

                person goes beyond these certain things, the treatment and the opinions that are

                relegated and relating to that treatment, that they move into a—potentially move

                into this different realm. *** [A]ll of these opinions that are given, all of these

                conclusions that are given, all of these critiques and criticisms and the animation

                and the other thing, it just keeps adding to the side in favor of saying I think

                maybe she’s reached that point.”

¶ 102 Plaintiff’s counsel reiterated that he “agree[d] to be bound by F3 disclosure

requirements,” but expressed concern that designating Dr. Rajamannan as a 213(f)(3) witness

would allow defense counsel to “stand in front of the jury at trial and *** say, that’s [plaintiff’s

counsel]’s witness. *** That’s the Plaintiff’s hired expert. That’s their retained [witness]—and

she’s not.”

¶ 103 Defense counsel agreed that he would not say “she’s their hired expert” or “anything

other than what I’ve represented in the court which is the factual truth, which is that they sought

her out because they knew she was on a crusade to try to destroy [Dr.] McCarthy. That she wants

to blame [Dr.] McCarthy and others that were not her employers for her losing her job at

[NMFF].”




                                                37
No. 1-17-0553


¶ 104 The court then found that Dr. Rajamannan was “subject to F3 disclosures” and that, since

plaintiff was the one to notice Dr. Rajamannan’s deposition, the payment of the deposition fee

“[wa]s on [plaintiff].”

¶ 105 In this appeal, plaintiff contends that Dr. Rajamannan should not have been classified as a

controlled expert witness because she was formerly employed by NMFF, and had “close ties to”

the Northwestern defendants.

¶ 106 As stated above, in the circuit court, plaintiff agreed to provide “full disclosure on

anything Dr. Rajamannan has to say before she gets to trial under [Rule 213(f)(3)].” The concern

plaintiff’s counsel then expressed was regarding whether defense counsel could then argue to the

jury that Dr. Rajamannan was plaintiff’s “retained,” or “hired expert,” and defense counsel

agreed to not make such statements to the jury.

¶ 107 On appeal, plaintiff continues to maintain that she “did not object to disclosing all of Dr.

Rajamannan’s opinions consistent with the format of Rule 213(f)(3).” She contends, however

that the trial court’s order finding Dr. Rajamannan to be plaintiff’s Rule 213(f)(3) witness is

“contrary to the plain language of *** Rule 213(f)(3).” Plaintiff asserts that the order “adversely

affect[ed] Plaintiff because it places obligations on Plaintiff that come with control over an

expert, where Plaintiff has no control over this witness.”

¶ 108 As an initial matter, we note that the only authority plaintiff cites in support of her

argument is the Supreme Court Rule itself, which provides the particular disclosures a party must

make regarding controlled expert witnesses. Plaintiff, however, did not object to making such

disclosures. Accordingly, it is unclear to this court how the designation of Dr. Rajamannan as a

controlled expert witness affected plaintiff, or what relief plaintiff is seeking. Importantly, Dr.

Rajamannan testified at trial, and plaintiff does not specify any particular testimony she was



                                                  38
No. 1-17-0553


prevented from presenting as a result of the doctor’s controlled witness designation. Plaintiff also

does not contend that defense counsel improperly referred to Dr. Rajamannan as a hired expert,

contrary to counsel’s prior representations.

¶ 109 The only way that plaintiff specifically contends that the designation “negative[ly]

affect[ed]” her is that in its denial of plaintiff’s motion for a new trial, the trial court stated,

“Plaintiff chose Dr. Rajamannan as her expert. Although Plaintiff claims she did not control Dr.

Rajamannan, she was designated as an (f)(3) witness in this case.”

¶ 110 This court has reviewed the order denying plaintiff’s motion for a new trial, which

plaintiff references. The trial court’s comment was made in the context of explaining Dr.

Rajamannan’s testimony, and the various ways in which her credibility was questionable. We do

not find the trial court’s statement that plaintiff “chose Dr. Rajamannan as her expert” and the

brief reference to the fact that the doctor was designated as a controlled expert witness, to show

that she was negatively affected by such designation.

¶ 111 Plaintiff’s next challenge concerns certain cross-examination of Dr. Rajamannan.

Plaintiff specifically contends that the trial court abused its discretion by allowing cross­

examination of Dr. Rajamannan on “collateral matters.” Plaintiff asserts that the cross­

examination “covered subjects that had no tendency to prove or disprove any of the material

issues in Plaintiff’s case.” Plaintiff specifically objects to cross-examination focusing on Dr.

Rajamannan’s employment disputes with Northwestern, reports Dr. Rajamannan made to the

media about the Myxo ring, Dr. Rajamannan’s dealings with governmental agencies, and the qui

tam action filed by Dr. Rajamannan.

¶ 112 Prior to trial, plaintiff filed several motions in limine seeking to bar questioning of Dr.

Rajamannan regarding her employment disputes with Northwestern, reports she made to the



                                                39
No. 1-17-0553


media about the Myxo ring, her dealings with governmental agencies, and the qui tam action.

The trial court denied plaintiff’s motions, finding that questioning on these matters was

appropriate, as it went to Dr. Rajamannan’s bias towards defendants.

¶ 113 During cross-examination, defendants elicited testimony from Dr. Rajamannan that she

was suspended from NMFF, that she submitted a qui tam action in the United States District

Court to the Northern District of Illinois asserting that Dr. McCarthy was improperly using an

investigational device during surgeries, and that she reached out to various media outlets

regarding her allegations against Dr. McCarthy. Dr. Rajamannan also stated that she wrote

several internet blogs, and self-published 13 E-books regarding her allegations about the Myxo

ring. 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.

¶ 114 Plaintiff contends that this line of cross-examination was “an improper attempt to

impeach a witness on collateral matters” and that the cross-examination subjects were not

relevant. Plaintiff asserts that the testimony was elicited to “create the appearance she was just

another hysterical woman who needed these other sources to vent her feelings” and that “her

extraordinary experience and prestige should be disregarded because she lacked emotional

control.”

¶ 115 We note, initially, that plaintiff asserts that eliciting this testimony constitutes

“impeachment of a witness on collateral matters.” Impeachment, however, occurs where a

witness testifies in a certain way, and the opposing party seeks to discredit that testimony

through the use of other evidence. Black’s Law Dictionary defines “impeach,” in relevant part,

as, “To discredit the veracity of (a witness),” and “impeachment” as, “The act of discrediting a



                                               40
No. 1-17-0553


witness, as by catching the witness in a lie or by demonstrating that the witness has been

convicted of a criminal offense.” Black’s Law Dictionary 755 (7th ed. 1999). Here, there was no

challenge to Dr. Rajamannan’s veracity. The relevant testimony was elicited directly from Dr.

Rajamannan, who acknowledged these activities willingly during cross-examination. In such

circumstances, the rule against impeaching a witness on collateral matters is inapplicable.

¶ 116 Plaintiff’s actual challenge appears to be to the relevancy of the above cross-examination.

Relevant evidence is evidence which has a tendency to make the existence of any material fact

more or less probable than it would be without the evidence. Worsley v. Farmington Pizza Co.,

322 Ill. App. 3d 371, 373 (2001). The relevance and admissibility of evidence at trial is within

the discretion of the trial court. Id. We will not overturn the decision of the trial court absent an

abuse of that discretion resulting in substantial prejudice. Id.

¶ 117 In this case, the court denied plaintiff’s motions in limine, and overruled her objections

regarding Dr. Rajamannan’s suspension from NMFF and subsequent activities, finding that such

evidence was admissible because it went to potential bias against defendants. In ruling on

plaintiff’s motion for a new trial, the trial court explicitly explained its evidentiary ruling, stating:

                        “It would have been unfairly prejudicial to the defense and denied

                Defendants a fair trial if this witness, a former colleague of Dr. McCarthy and

                former NMFF employee, had been permitted to offer ‘expert’ opinions that were

                critical of Defendants without allowing the jury to know that Dr. Rajamannan had

                been involuntarily terminated from NMFF and that she has claimed quite

                publicly, in multiple venues, media outlets and in litigation that she was

                terminated in retaliation for having raised allegations pertaining to the Myxo ring.




                                                   41
No. 1-17-0553


                        The Court further ruled, however, that Defendants would be extremely

                limited in the evidence they were permitted to present on this issue. Defendants

                were limited to demonstrating the fact of Dr. Rajamannan’s dismissal, but were

                prohibited from discussing the details of her dismissal.

                        As such, the discussion of Dr. Rajamannan’s dismissal during the trial of

                this case was extremely limited. *** This Court agrees with the Defendants that it

                would have been grossly unfair to Defendants to prohibit them from disclosing

                Dr. Rajamannan’s termination to the jury. This Court ensured, however, that the

                issue did not dominate the evidence.

                                                         ***

                        This Court agrees with the Defendants that Dr. Rajamannan’s animosity

                towards the Defendants and the extent of her efforts to attempt to blame Dr.

                McCarthy for her dismissal from NMFF are significant and relevant areas of

                inquiry. These activities (particularly her filing her own lawsuit against Dr.

                McCarthy seeking money damages) are classic examples of bias. It would have

                been unjust to the Defendants to conceal these activities from the jury. There was

                no unfair prejudice to Plaintiff that deprived her of a fair trial. This was a relevant

                area of inquiry for cross examination.”

¶ 118 It is well-established that the potential bias of a witness is a relevant topic for cross

examination. See Pierce v. Commonwealth Edison Co., 101 Ill. App. 3d 272, 276 (1981) (finding

“the failure to permit an inquiry into the possible bias of the witness would constitute prejudicial

error requiring a new trial”); see also Ill. R. Evid. 607 (eff. Jan. 1, 2011) (“credibility of a witness

may be attacked by any party”); Ill. R. Evid. 611 (eff. Oct. 15, 2015) (the subject of cross­



                                                  42
No. 1-17-0553


examination may include “matters within the knowledge of the witness that explain, qualify,

discredit or destroy the witness’s direct testimony”). In Sanchez v. Black Brothers Co., 98 Ill.

App. 3d 264, 271 (1981), the appellate court explained the particular importance of this rule in

cases involving expert testimony:

                “Expert testimony on matters not within common knowledge and experience is

                sometimes necessary to enable jurors to determine the factual issues submitted to

                them. However, the expert witness is usually a hired partisan. Moreover, it is

                unlikely that he could be successfully prosecuted for perjury on the basis of his

                opinion testimony. Thus, while the expert’s opinion has the sanction of an oath, it

                lacks the substantial safeguard of truth that may be applied to the testimony of

                other witnesses. For these reasons, counsel must be given the widest possible

                latitude during cross-examination to demonstrate any interest, bias or motive of

                the expert witness to testify.”

¶ 119 The supreme court has also acknowledged the importance of cross-examination of expert

testimony, stating that it has “long recognized that the principal safeguard against errant expert

testimony is the opportunity of opposing counsel to cross-examine, which includes the

opportunity to probe bias, partisanship or financial interest.” Trower v. Jones, 121 Ill. 2d 211,

217 (1988).

¶ 120 Here, the trial court concluded that the above testimony regarding Dr. Rajamannan’s

suspension from NMFF and her subsequent activities critical of defendants were relevant to

show her potential bias toward defendants. In these circumstances, we find no abuse of discretion

in its decision. Worsley, 322 Ill. App. 3d at 373.




                                                  43
No. 1-17-0553


¶ 121 Plaintiff also objects to the court’s rulings on her objections, which the court overruled,

stating that it “Goes to bias. *** Potential bias.” Plaintiff contends that by overruling her

objections in such a way, the judge “effectively declared before the jury” that Dr. Rajamannan

was “a biased witness,” and “admonished the jury to consider the evidence as showing that the

witness is biased.” In support, plaintiff cites Nastasi v. United Mine Workers of America Union

Hospital, 209 Ill. App. 3d 830, 843-44 (1991), which provides that a “trial judge himself must be

fair and impartial, conduct himself so as not to give the jury the impression of his feelings, and

not make any comments or insinuations indicative of an opinion on the credibility of a witness.”

We disagree that the trial judge’s brief rulings on plaintiff’s objections indicated to the jury any

opinion of the credibility of Dr. Rajamannan.

¶ 122 In overruling plaintiff’s objections to defendants’ cross-examination questions, the trial

judge stated that the questions “[went] to bias,” later correcting himself to state “potential bias.”

Such statements cannot reasonably be interpreted to be explicit indications of the trial judge’s

negative opinion on Dr. Rajamannan’s credibility. Instead, it is clear that the trial judge was

indicating that the questions were relevant to the question of Dr. Rajamannan’s bias, which, as

stated above, is a proper subject of cross-examination.

¶ 123 Finally, plaintiff argues that the court abused its discretion in permitting Dr. McCarthy to

testify that he donated the royalties he received from sale and use of the Myxo ring to the Greater

Chicago Food Depository. She claims that Dr. McCarthy should have been barred from

presenting such testimony for two reasons: first, because he did not produce documentation of

the donations in response to a written discovery request, and second, because the testimony was

“improper evidence of good character.”




                                                 44
No. 1-17-0553


¶ 124 The record shows that on March 14, 2016, just before opening statements were set to

begin, plaintiff presented a motion in limine seeking to bar Dr. McCarthy from testifying that he

donated the royalties from the Myxo ring. Plaintiff’s counsel contended that Dr. McCarthy had

been issued a Supreme Court Rule 214 request to produce documents substantiating his

donations, and that Dr. McCarthy never produced the requested documents. In response,

defendants pointed out that Dr. McCarthy had objected to plaintiff’s written discovery request as

overly broad and unduly burdensome, and that plaintiff never revisited the request in a 201(k)

request, motion to compel, or otherwise, following defendants’ objection.

¶ 125 After hearing arguments from the parties, the court stated:

                 “There should have been follow-up, though, all along. For me, on the eve of trial,

                 to be presented with, ‘I should bar them from being able to say—to even bring

                 that up that he donated it,’ I’m not going to bar them from doing that. So you’re

                 obviously going to cross-examine him about all of that, but it should have been

                 followed up all through the discovery process, not at the eve of the trial.”

¶ 126 At trial, Dr. McCarthy testified as follows regarding his donations of the royalties from

the Myxo ring:

                 “Q: By the way, what is your share of royalties from the Myxo ring?

                 A: So the royalties are actually paid to the Cleveland Clinic and then the

                 Cleveland Clinic pays me a portion of that. So it comes *** out to $50 per ring.

                 Now, I don’t even want patients even remotely thinking that I would change their

                 treatment based on $50.

                 PLAINTIFF’S COUNSEL: Objection.

                 THE COURT: Overruled.



                                                  45
No. 1-17-0553


                A: So what I have done is that anytime any surgeon at Northwestern implants any

                of my rings, I have to accept the money from the Cleveland Clinic because the

                Cleveland Clinic funds the money from Northwestern, but I then donate that

                money to charity. I give it to the Greater Chicago Food Depository because I do

                not want any patient thinking that I might have had a conflict and chose my ring

                as opposed to some other ring over $50.”

¶ 127 In this court, plaintiff first claims that Dr. McCarthy should have been barred from

presenting such testimony because he did not produce documentation of the donations in

response to her discovery request. Pursuant to Illinois Supreme Court Rule 219(c), a trial court

may choose to impose a sanction upon any party who unreasonably refuses to comply with

discovery rules. Ill. S. Ct. R. 219(c) (eff. July 1, 2002); see also Shimanovsky v. Gen. Motors

Corp., 181 Ill. 2d 112, 120 (1998). The decision as to whether to impose a sanction for the

violation of a discovery rule falls within the discretion of the trial court, and only a clear abuse of

discretion justifies reversal. Id.; Boyd v. City of Chicago, 378 Ill. App. 3d 57, 68 (2007). When

imposing sanctions, the trial court must consider the surprise to the adverse party, the prejudicial

effect of the witness’s testimony, the nature of the testimony, the diligence of the adverse party,

the timeliness of the objection, and the good faith of the party seeking to offer the testimony.

Santorini Cab Corp. v. Banco Popular North America, 2013 IL App (1st) 122070, ¶ 21. No

single factor is determinative, and each case presents a unique factual situation that the court

must consider. Id.

¶ 128 The circumstances here support the trial court’s conclusion that no discovery sanction

was warranted. Plaintiff was not surprised by Dr. McCarthy’s testimony regarding his donation

of the royalties from the Myxo ring, as she had been aware that he would so testify since his first



                                                  46
No. 1-17-0553


deposition in June 2012, almost four years prior to trial. Further, plaintiff sought to present the

theory at trial that Dr. McCarthy profited from his decision to use the Myxo ring during her

surgery and others. In these circumstances, Dr. McCarthy’s testimony would not be prejudicial to

plaintiff as it was being presented to rebut plaintiff’s theory. Finally, plaintiff never followed up

on defendants’ objection to producing the supporting documents, and instead waited until the day

trial was to begin to seek to bar such testimony. Accordingly, plaintiff’s lack of diligence, and

the untimeliness of her objection, also weigh in favor of allowing Dr. McCarthy’s testimony. In

these circumstances, we find no abuse of discretion on the part of the circuit court in choosing

not to bar Dr. McCarthy’s testimony regarding his donation of the royalties of the Myxo ring.

¶ 129 Similarly, we also reject plaintiff’s contention that the trial court should have barred such

testimony as “improper evidence of good character.”

¶ 130 Initially, we note that in defendants’ response brief, they point out that at trial, plaintiff

relied only on the theory that such testimony should be barred based on the alleged discovery

violation, and she never raised the issue that allowing such testimony would be improper

character evidence. Because plaintiff deprived the court of considering this basis, defendants

contend that she should be barred from raising this issue on appeal. In plaintiff’s reply brief, she

presents no response to defendants’ contention that she failed to preserve this issue. We agree

with defendants.

¶ 131 “It is a fundamental rule of law in Illinois that a party desiring to preserve a question for

review must make appropriate objection in the court below, and that a failure to object to

preserve a question for review constitutes a waiver.” Brown v. Timpte Inc., 137 Ill. App. 3d

1053, 1062-63 (1985). “Objections should be sufficiently specific to inform the court of the

ground for the objection, and a general objection, if overruled, will not preserve the issue for



                                                 47
No. 1-17-0553


review on appeal.” Carlson v. City Construction Co., 239 Ill. App. 3d 211, 239 (1992) (citing

People v. Queen, 56 Ill. 2d 560, 564 (1974)).

¶ 132 In this case, plaintiff’s counsel objected to Dr. McCarthy’s testimony that he donated the

royalties of the Myxo ring, but stated only “Objection,” and did not offer any further

specification. Accordingly, the general objection did not suffice to preserve this issue for review,

and we consider it waived. Although plaintiff did raise this issue in her motion for a new trial,

“issues raised for the first time in a post-trial motion will not be considered.” Zdeb v. Baxter

International, Inc., 297 Ill. App. 3d 622, 630 (1998).

¶ 133 Nonetheless, even if plaintiff had not waived review of this issue, we would still conclude

that it fails on the merits. “[T]he admissibility of evidence is a matter for the sound discretion of

the trial court, and its decision will not be reversed on appeal unless that discretion has been

clearly abused.” Leonardi v. Loyola University of Chicago, 168 Ill. 2d 83, 92 (1995).

¶ 134 At trial, it was plaintiff who first introduced the theory that Dr. McCarthy stood to profit

by using the Myxo ring. In opening statements, plaintiff’s counsel emphasized that Dr. McCarthy

“received royalties” from the Myxo ring, and that this fact was not disclosed to his patients.

Plaintiff’s counsel also elicited testimony from Dr. Rajamannan that Dr. McCarthy violated the

standard of care, and that he was “required to give disclosures in regard to his Myxo study that

pertain[ed] to conflicts of interest” because he invented the device and stood to benefit from

“potential royalties.”

¶ 135 Accordingly, Dr. McCarthy’s testimony pertaining to his donation of Myxo ring royalties

to the Greater Chicago Food Depository was not offered as evidence of good character, but

instead was relevant to rebut plaintiff’s theory that Dr. McCarthy financially benefited from the

Myxo ring. To allow plaintiff to argue that money motivated Dr. McCarthy to use an



                                                 48
No. 1-17-0553


“experimental” medical device without allowing Dr. McCarthy to testify that he did not actually

profit from the Myxo ring would have been fundamentally unfair. See Werdell v. Turzynski, 128

Ill. App. 2d 139, 150 (1970) (“It is a rule of fundamental fairness that evidence that would

otherwise be irrelevant or incompetent, if offered by one party in the first instance, may become

relevant in rebuttal or to explain evidence offered or injected into the record by the adversary.”).

In these circumstances, we would find no abuse of discretion by the trial court in allowing such

testimony.

¶ 136 For the foregoing reasons, we affirm the judgment of the circuit court of Cook County.

¶ 137 Affirmed.




                                                49
