Obermeier v. Nw. Mem'l Hosp.

• Decision Date: 28 June 2019
• Docket Number: No. 1-17-0553,1-17-0553
• Citation: 434 Ill.Dec. 15,2019 IL App (1st) 170553,134 N.E.3d 316
• Parties: Maureen OBERMEIER, Plaintiff-Appellant, v. NORTHWESTERN MEMORIAL HOSPITAL, Northwestern Medical Faculty Foundation, Patrick McCarthy, M.D., and Edwards Lifesciences, LLC, Defendants-Appellees.
• Court: United States Appellate Court of Illinois

2019 IL App (1st) 170553

134 N.E.3d 316

434 Ill.Dec. 15

Maureen OBERMEIER, Plaintiff-Appellant,

v.NORTHWESTERN MEMORIAL HOSPITAL, Northwestern Medical Faculty Foundation, Patrick McCarthy, M.D., and Edwards Lifesciences, LLC, Defendants-Appellees.

No. 1-17-0553

Appellate Court of Illinois, First District, FOURTH DIVISION.

June 28, 2019

Ardwin E. Boyer, of Newman, Boyer & Statham, Ltd., of Chicago, for appellant.

Kirk D. Bagrowski, David C. Jensen, and Robert J. Feldt, of Eichhorn & Eichhorn, LLP, of Hammond, Indiana, for appellee Edwards Lifesciences LLC.

Jason A. Parson and Christopher C. Heery, of Anderson, Rasor & Partners, LLP, of Chicago, for other appellees.

OPINION

PRESIDING JUSTICE McBRIDE delivered the judgment of the court, with 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 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...