Obermeier v. Northwestern Memorial Hospital
2019 IL App (1st) 170553
| Ill. App. Ct. | 2019Background
- Plaintiff Maureen Obermeier underwent mitral valve repair by Dr. Patrick McCarthy at Northwestern Memorial Hospital (NMH) in November 2006; Dr. McCarthy implanted a 36 mm “Myxo ring” that he helped design and which was manufactured by Edwards.
- Plaintiff alleged the Myxo ring was investigational/not properly cleared by the FDA and that McCarthy used it as part of an unauthorized study without proper IRB oversight or informed consent, asserting claims including informed consent, medical negligence and battery; Edwards was dismissed before trial on several counts.
- After a 14-day jury trial, the jury returned general verdicts for defendants on the claims tried (informed consent and negligence against McCarthy and associated institutional respondeat superior claims), and the trial court entered judgment for defendants and denied plaintiff’s post-trial motion.
- On appeal plaintiff challenged: prior dismissals and a summary-judgment ruling that dismissed counts against NMH, NMFF, and Edwards; the trial court’s exclusion of certain IRB/protocol documents under the Medical Studies Act (MSA); designation of Dr. Rajamannan as a controlled expert under Supreme Court Rule 213(f)(3); certain cross-examination; and allowance of testimony that McCarthy donated royalties.
- The appellate court affirmed: it held institutional informed-consent and battery claims against NMH/Edwards were barred by estoppel from the jury verdict and, independently, failed as a matter of law (no hospital duty where device not treated as investigational; FDCA preemption of claim against Edwards); it upheld exclusion under the MSA of IRB/protocol materials, affirmed the Rule 213(f)(3) designation and related cross-examination about bias, and declined to bar McCarthy’s testimony about donating royalties.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Dismissal of institutional informed-consent/battery claims against NMH and battery against Edwards | Obermeier: hospital and manufacturer liable because Myxo ring was investigational and patients should have been told; hospital undertook duty to secure consent | NMH/Edwards: ring was lawfully cleared/marketed; no institutional duty because device not treated as investigational; FDCA preempts state claims against manufacturer | Affirmed. Jury verdict estoppel bars relitigation; alternatively, no hospital duty here (no evidence hospital undertook IRB/consent obligation) and claims against Edwards preempted by FDCA/Buckman |
| Dismissal of agency claim (Count V) that McCarthy was Edwards’ agent | Obermeier: alleged consultant relationship, paid by Edwards, participated in design/marketing supports agency | Edwards: pleadings lack specific facts showing control or that plaintiff relied on apparent agency; agency not established | Affirmed. Pleadings insufficient to show actual or apparent agency; agency is fact question but plaintiff failed to allege controlling facts |
| Summary judgment on products-failure-to-warn claim against Edwards | Obermeier: Edwards negligently failed to ensure patients got information (e.g., about FDA status); regulatory shortcuts created factual disputes | Edwards: claim is effectively federal FDCA claim; no private cause of action for alleged violations; ring was cleared via JTF pathway | Affirmed. Claim would amount to private enforcement of FDA regime and is precluded by Buckman |
| Exclusion of IRB/protocol documents under Medical Studies Act (MSA) | Obermeier: documents necessary to show Myxo ring was being studied without IRB approval; exclusion frustrates fact-finding | Defendants/Northwestern University: documents are privileged under MSA as materials used in medical study/internal quality control | Affirmed. Documents fall within MSA privilege; even if excluded, plaintiff had testimonial alternatives and no demonstrated prejudice |
Key Cases Cited
- Kus v. Sherman Hospital, 268 Ill. App. 3d 771 (hospital may incur duty to obtain informed consent when it undertakes IRB/clinical-trial responsibilities)
- Lenahan v. University of Chicago, 348 Ill. App. 3d 155 (hospital liability for institutional informed consent where hospital adopts policies and IRB oversight for trials)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (private suits alleging violations of FDA regulatory scheme are preempted; enforcement is federal)
- HPI Health Care Services, Inc. v. Mt. Vernon Hospital, 131 Ill. 2d 145 (plaintiff must plead specific factual allegations to support agency; mere assertions insufficient)
- Doe v. Illinois Masonic Medical Center, 297 Ill. App. 3d 240 (IRB protocols and related materials fall within MSA privilege)
- Lazenby v. Mark's Construction, Inc., 236 Ill. 2d 83 (general jury verdicts stand where any presented theory is supported; absence of special interrogatories precludes knowing on which theory jury relied)