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Obermeier v. Northwestern Memorial Hospital

Court of Appeals of Illinois, First District, Fourth Division

June 28, 2019

MAUREEN OBERMEIER, Plaintiff-Appellant,
v.
NORTHWESTERN MEMORIAL HOSPITAL, NORTHWESTERN MEDICAL FACULTY FOUNDATION, PATRICK MCCARTHY, M.D., and EDWARDS LIFESCIENCES, LLC, Defendants-Appellees.

          Appeal from the Circuit Court of Cook County 08 L 012426 Honorable James M. McGing, Judge Presiding

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

          OPINION

          McBRIDE PRESIDING JUSTICE

         ¶ 1 Plaintiff, Maureen Obermeier, brought various claims against defendants, Northwestern Memorial Hospital (NMH), Northwestern Medical Faculty Foundation (NMFF), Patrick McCarthy, M.D. (Dr. McCarthy), and Edwards Lifesciences, LLC (Edwards), arising out of a heart surgery Dr. McCarthy performed on her in November 2006. Plaintiff generally contended that Dr. McCarthy utilized a medical device called a "Myxo ring" during the surgery, which was invented by Dr. McCarthy and manufactured by Edwards. Plaintiff claimed that the Myxo ring had not been approved or cleared by the FDA, that it was investigational, and that Dr. McCarthy improperly utilized the Myxo ring during her surgery as part of a study. Following a 14-day jury trial, the jury found in favor of defendants and against plaintiff on all 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 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.

         ¶ 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 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.

         ¶ 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.

         ¶ 19 The investigational devices are only handled by a research team in the Clinical Trials Unit. They are kept in a location separate from commercially available devices that are used in the hospital, and they are labeled in big, bold letters as "Investigational." Nurse Huskin testified that there is no mistaking an investigational device's labeling when it is shipped.

         ¶ 20 Nurse Huskin further testified that the Myxo ring was never shipped to the Clinical Trials Unit, and it did not come through Nurse Huskin's office. Her understanding was that the Myxo ring was approved, since it was shipped commercially through standard channels. No one from Edwards suggested to her or to anyone else at the Clinical Trials Unit that the Myxo ring had not been cleared by the FDA. If they had been told that, there would have been a completely different process. Neither she nor Dr. McCarthy had any role in deciding whether something is an investigational device. Nurse Huskin testified that there are thousands of FDA-regulated medical devices that are used in a hospital every day. The institution receives those products from manufacturers, assuming that they are being marketed according to FDA requirements. Northwestern University's IRB does not deal with what path a device goes through for FDA clearance. Nurse Huskin and the people at NMH rely on manufacturers to alert them if a device is investigational.

         ¶ 21 Nurse Huskin was aware that Dr. McCarthy authored a paper on the Myxo ring. She had helped work on it by pulling patient information on patients who underwent myxomatous mitral valve repair surgery. Nurse Huskin testified that she would not characterize it as a "study," but rather a "retrospective chart review." A "study" has more of an organized design where patients are followed at specific intervals. The information that was used for the papers was gathered from the "Outcomes Registry" and there was approval to study or evaluate the data that was within that database.

         ¶ 22 Plaintiff signed a consent form to be part of the Outcomes Registry at Northwestern University. The Cardiac Surgery Outcomes Registry is a large-scale registry that the Clinical Trials Unit runs. Nurse Huskin has been involved with the Outcomes Registry since its inception. It is a project where they collect information on all cardiac surgery patients who are undergoing cardiac surgery. The Society of Thoracic Surgeons (STS) has a national registry/database, and they encourage teaching institutions across the country to gather information for the purpose of conducting studies after patients receive care, maintaining quality, and to better understand how patients have responded to different modes of treatment. Among the information that is captured on a patient is any device that is used in cardiac surgery.

         ¶ 23 NMH has a quality assurance initiative to submit data to the STS national database. The Clinical Trials Unit seeks to obtain the consent of all cardiac surgery patients to allow the CTU to maintain the patient's data in the Northwestern University Cardiac Surgery Outcomes Registry as well as the STS national database. The Outcomes Registry has been in existence since 2005, and it is approved by the IRB. After the patient has consented to the Outcomes Registry, all data from the STS database also goes to the Outcomes Registry, which allows Northwestern University to review the database, and to have papers written like that of Dr. McCarthy. Over the years, Nurse Huskin has been involved in over 100 projects similar to the paper that Dr. McCarthy published. In those situations, the physician goes back and searches the database for patients who have already undergone care and puts the information into a publication. In all those cases, the consent that the patient signed that justified going back and pulling their data was the same Outcomes Registry consent form that plaintiff signed in this 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. She confirmed that there was no interaction between Edwards and Dr. McCarthy during the regulatory phase of developing the Myxo ring and that she did not discuss the regulatory status of the ring with Dr. McCarthy at any time. She did not describe the available pathways to market or discuss the regulatory pathway that Edwards planned to take with the Myxo ring with Dr. McCarthy. Edwards has very large departments of experts that do nothing but FDA filing and interfacing with the FDA. The ring was made available to Dr. McCarthy in March 2006, after it had gone through the regulatory process. It is customary, and an FDA requirement, for Edwards to place large print labeling on investigational products that says, "For Investigational Use Only." The Myxo ring was never labeled or packaged as "investigational" at any point in time, and nothing about the marketing or handling of the ring by Edwards suggested it was investigational. Ms. Curtis never told Dr. McCarthy that it was investigational. Edwards never considered the Myxo ring to be investigational.

         ¶ 25 Susan Gamble, Senior Director of Regulatory Affairs for the heart valve therapy division at Edwards also testified at trial. She explained how the "Justification to File" (JTF) pathway to market a product works.

         ¶ 26 The FDA has prescribed pathways for the marketing of Class II medical devices, including annuloplasty rings, when the device is a minor modification of a substantially equivalent device previously cleared or approved by the FDA. The FDA guidelines, specifically the 1997 guidance document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device," provides that a device which constitutes a minor modification to a device or devices previously cleared by the FDA can be marketed after the manufacturer has completed a comprehensive evaluation of the device as prescribed by the guidance document.

         ¶ 27 Ms. Gamble testified that, with regard to the Myxo ring, Edwards complied with the guidance document and completed the JTF process on February 27, 2006. The JTF remains in the records of a device manufacturer so it is available for inspection by the FDA.

         ¶ 28 Ms. Gamble clarified that annuloplasty rings are not "approved" by the FDA, but are "cleared." If a JTF is utilized, there is no requirement that Edwards do anything to tell the FDA it is distributing or marketing the device. It was Ms. Gamble who made the decision regarding the regulatory pathway of the Myxo ring, with the agreement of her senior management. Edwards never considered the Myxo ring to be an investigational product, and it never was an investigational product. Ms Gamble confirmed that Edwards did not involve Dr. McCarthy in the regulatory pathway discussion, and did not talk to Dr. McCarthy about their decision to proceed with the JTF.

         ¶ 29 Jeffrey Cooper, M.D., testified as a retained expert at trial on behalf of defendants. He is a board-certified physician in Pediatrics and Nuclear Medicine who has also conducted medical research, served as a clinical investigator for industry-sponsored medical research, and served on IRBs and as chairman of an IRB. He is a founder and authored the standards for the Association for the Accreditation of Human Research Protection Programs (AAHRPP), a nonprofit organization that reviews and accredits institutions that conduct human research, including hospital or universities that have IRBs.

         ¶ 30 Dr. Cooper explained that not all medical research is regulated by the federal government. A "clinical trial" has an investigator who is testing and comparing specific devices or drugs. A characteristic of a clinical trial is that there is a protocol, and the protocol mandates what procedures are done and what care is going to be administered. In a device clinical trial, the protocol will determine which device a patient receives. Two devices will be used, and the device that is used with a given patient is assigned randomly. In a non-clinical trial, the care is determined by the treating physician. No protocol mandates the use of any particular medical procedure, drug, or device in terms of treatment. When an investigator collects and analyzes specimens or data, that is not a clinical trial. It is also not a clinical trial when the care for each patient is determined by the treating physician, data is collected from patients who have a particular procedure, and the investigator analyzes the data after the fact to see which treatments worked best for which patients. In clinical care, each decision is made for the individual patient, and the actions taken are always for the benefit of the patient.

         ¶ 31 Dr. Cooper opined that, under FDA regulations, plaintiff was not a human subject involved in a clinical investigation when Dr. McCarthy utilized a Myxo ring in her surgery. Dr. McCarthy implanted the Myxo ring because he felt that it was the best treatment for her. Dr. McCarthy's use of the Myxo ring was not based upon a protocol for evaluating the safety or effectiveness of the device. Accordingly, Dr. McCarthy was not a "clinical investigator" under FDA regulations when he used the Myxo ring, and there was no clinical investigation. Furthermore, under FDA regulations, Dr. McCarthy was not required to treat the Myxo ring as an investigational device. Therefore, Dr. Cooper stated that Dr. McCarthy was not required to obtain research consent under FDA or IRB requirements before he implanted the Myxo ring in 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 has an IDE, and provide a proposed protocol for the use of the device, along with a proposed consent. The manufacturer must obtain a signed agreement of how the study is to be conducted from the institution where the study is to be conducted. It must make sure that the physician obtains IRB review of the protocol and the consent, prominently label the device as "investigational," and it cannot charge for an investigational device. Edwards did not do any of these things with the Myxo ring. Edwards treated the Myxo ring as an FDA cleared device, because they believed it was cleared pursuant to FDA guidelines. Furthermore, Dr. Cooper stated that the standard of care did not require Dr. McCarthy to investigate whether the Myxo ring had been cleared by the FDA before he used it.

         ¶ 33 Dr. Cooper also opined that a physician may study any data pertaining to any clinical care listed in the Outcomes Registry, including devices or drugs, and that plaintiff's consent to include her clinical data in the Outcomes Registry had nothing to do with the use of the Myxo ring during her surgery.

         ¶ 34 Plaintiff called Bruce Barkalow, Ph.D., as an expert witness on FDA matters and medical devices. He acknowledged that he was neither a physician, nor an expert on anatomy, the mitral valve, mitral valve rings, or surgical techniques. Dr. Barkalow opined that Edwards did not secure proper clearance under FDA procedures to market the Myxo ring before it was used on plaintiff. Dr. Barkalow conceded, however, that it would not surprise him that a physician would defer to a manufacturer as to what is required for FDA clearance. He would expect Dr. McCarthy to rely upon lawyers and FDA experts within Edwards to make that determination. He also acknowledged that it is not unusual for a study using data from a registry to be conducted even after a device has been cleared by the FDA and marketed.

         ¶ 35 Plaintiff also called Nalini Rajamannan, M.D., as an expert witness. Dr. Rajamannan had previously been employed by NMFF and had previously worked with Dr. McCarthy. Dr. Rajamannan's opinion was that Dr. McCarthy was conducting a clinical trial on the Myxo ring without IRB approval and that he was obligated to obtain IRB-approved consent from plaintiff before implanting the Myxo ring, because it was an investigational device. She opined that "Dr. McCarthy violated the standard of care in regard to his failure to *** obtain informed consent [from plaintiff] on his Myxo ring study." Dr. Rajamannan also testified regarding her theories as how the Myxo ring posed risks not posed by other rings. Dr. Rajamannan believed that one of two possibilities occurred during plaintiff's surgery. Specifically, either the triangular shape of the Myxo ring caused narrowing in the artery, or a suture was placed through the artery causing an obstruction. She acknowledged however, that the risk from suturing was not unique to the Myxo ring, and was present for all annuloplasty rings used in mitral or valve repair 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 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 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 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 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]" ...


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