Lenahan v. University of Chicago
808 N.E.2d 1078, 348 Ill. App. 3d 155, 283 Ill. Dec. 790 (2004)
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Rule of Law:
A hospital that voluntarily assumes responsibility for overseeing the informed consent process for a clinical trial in compliance with federal regulations owes a direct duty of care to the patient. Similarly, a physician-patient relationship creating a duty of care can be established without direct contact if the physician provides substantial services to the patient, such as designing the treatment protocol, directing other doctors, and analyzing test results.
Facts:
- Shawn Lenahan, who suffered from non-Hodgkin's lymphoma, sought treatment at the University of Chicago Hospitals in November 1998.
- His treating physician recommended he enroll in 'Protocol 8558,' a phase I clinical trial involving an experimental T-cell treatment run by University of Chicago doctors.
- The University of Chicago and its Hospital had an official policy stating they bore independent institutional responsibility to obtain informed consent from all clinical trial subjects in compliance with federal regulations, and they formed an Institutional Review Board (IRB) to ensure such compliance.
- Doctor David Liebowitz was the principal investigator for Protocol 8558; he designed the treatment plan, drafted the consent form, approved Lenahan's enrollment, and directed other physicians in administering treatment.
- Doctor Liebowitz also analyzed, counted, and managed the growth and expansion of Lenahan's T-cells in the lab as part of the protocol, but he never personally met with Lenahan.
- Doctor Stephanie Williams was a research director for the protocol, responsible for determining participants' eligibility, obtaining consent, and monitoring their progress.
- Lenahan enrolled in Protocol 8558 and died during the course of the treatment.
Procedural Posture:
- Karen Lenahan, on behalf of Shawn Lenahan's estate, filed a fifth amended complaint in an Illinois trial court against the University of Chicago, its hospital, and several doctors.
- The defendants filed a motion to dismiss several counts of the complaint for failure to state a cause of action upon which relief could be granted.
- The trial court granted the defendants' motion, dismissing counts XIII, XIV, XVI, XVII, XVIII, XIX, XX, and XXI.
- The trial court entered an order pursuant to Supreme Court Rule 304(a), finding no just reason to delay an appeal of the dismissal of those counts.
- The plaintiff, Karen Lenahan, appealed the trial court's dismissal to the Appellate Court of Illinois.
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Issue:
Does a hospital or a supervising physician in a clinical trial, who has no direct physical contact with a patient, owe a duty of care to that patient regarding informed consent and treatment when the hospital has established policies to oversee consent and the physician designs the protocol, directs other doctors, and analyzes the patient's test results?
Opinions:
Majority - Justice O’Brien
Yes. A hospital or supervising physician can owe a duty of care to a patient in a clinical trial even without direct physical contact. The court found that while the duty to obtain informed consent generally rests with the physician, a hospital can assume that duty. Here, the University and Hospital did so by establishing policies and an IRB to ensure compliance with federal regulations for clinical trials, thereby creating a direct duty to the decedent. Similarly, a physician-patient relationship is not limited to face-to-face encounters. A 'special relationship' giving rise to a duty of care exists when a physician provides services for the patient. Doctor Liebowitz's actions—designing the protocol, drafting the consent form, enrolling the decedent, directing other doctors, and analyzing the decedent's T-cells—constituted a 'myriad of services' sufficient to establish such a relationship and its corresponding duty. The court also found a special relationship existed with Doctor Williams due to her role in determining eligibility and monitoring the patient. However, the court affirmed the dismissal of the civil conspiracy claim, finding that the plaintiff failed to allege facts showing an agreement to commit a tortious act.
Analysis:
This decision significantly expands the scope of liability for institutions and physicians involved in medical research. It establishes that a hospital cannot avoid direct liability for failures in the informed consent process by delegating the duty to treating physicians, especially when the institution has created a formal oversight structure like an IRB. Furthermore, the ruling clarifies that physicians in supervisory or research roles can be held liable for medical negligence even without direct patient contact, provided their involvement in the patient's care is substantial. This precedent is crucial in the modern medical landscape, where team-based care and complex clinical trials often involve numerous professionals who contribute to a patient's treatment without ever meeting them.
