HOSPITAL ASSUMES DUTY TO OBTAIN INFORMED CONSENT

May 14, 2004

Steven P. Garmisa
Hoey & Farina Attorney
garmisa@hoeyfarina.com
1-888-425-1212

Doctors, not hospitals, usually have the duty to obtain informed consent.

Cases involving "clinical trials" illustrate an exception to this general rule.

Reversing a ruling by the Cook County Circuit Court, the Illinois Appellate Court decided that a malpractice complaint adequately alleged that a hospital running a clinical trial assumed and breached the obligation to get valid consent from a cancer patient.
Assuming that the facts alleged in the complaint are true, the reviewing court also concluded that (1) the hospital could be held liable for not adequately supervising a physician and (2) a doctor owed a tort duty to a patient he never personally encountered. Lenahan v. University of Chicago, 2004 WL 635570 (1st Dist., March 31).

Diagnosed with cancer, Shawn Lenahan participated in a clinical trial at the University of Chicago Hospitals involving a high-dose chemotherapy/stem-cell transplant regimen. The Phase I clinical trial was referred to as "Protocol 8558."

After Shawn Lenahan died, Karen Lenahan filed a complaint alleging that the University of Chicago Hospitals breached a duty to obtain informed consent. According to the complaint, Lenahan didn't give informed consent because he allegedly wasn't informed that 95 percent of the patients participating in the clinical trial were expected to die.

Alleging institutional negligence, the complaint also claimed that personnel supplied by the hospital failed to adequately monitor Lenahan or discontinue treatment when he began to have adverse reactions.

Another defendant was Dr. Liebowitz, the director of the clinical trial. Dr. Liebowitz apparently never had a face-to-face encounter with Lenahan, though he drafted the allegedly inadequate consent form.
The Circuit Court dismissed several claims, including the institutional negligence claims, and claims against Dr. Liebowitz.

Here are some highlights of Justice Sheila M. O'Brien's opinion reversing in part (with various omissions not noted in the quoted text).

Institutional negligence

"This case is similar to Kus v. Sherman Hospital, 268 Ill.App.3d 771 (1995). In Kus, a patient who was implanted with experimental intraocular lenses brought suit against Sherman Hospital and a physician for failure to obtain informed consent. The patient alleged that the consent form that he signed had been modified from the FDA-approved form and did not inform the patient that the lens was experimental and being evaluated for safety and effectiveness.
"The appellate court noted the general rule that physicians, not hospitals, have the duty to obtain informed consent from their patients. The rationale for this rule is that the physician has the knowledge and training necessary to advise each patient of the risks, whereas the hospital does not know the patient's medical history or the details of the particular surgery to be performed.
"However, the court further noted that intraocular lens implants were subject to specific FDA regulations regarding informed consent, and that pursuant thereto Sherman Hospital had established an Institutional Review Board (IRB) to assure that a legally effective informed consent was obtained.

"The court held that '[w]hile 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.' The court further held that under these 'particular facts,' a hospital as well as a physician may be held liable for claims arising from the lack of informed consent.

"Similarly," O'Brien recounted, "the FDA regulated Protocol 8558, and the hospital and university adopted policies and established an IRB to ensure that the consent forms complied with the applicable [Food and Drug Administration] and [Department of Health and Human Services] regulations. Under these facts, the hospital and university may be held liable for claims arising from lack of informed consent."

The consent form

"Defendants argue that the consent form attached to their motions to dismiss negate plaintiff's allegations of negligence. Plaintiff counters that the consent form failed to adequately inform the decedent of the risks involved. Plaintiff has stated a cause of action against the university and hospital related to the allegedly inadequate consent; it is for the trier of fact to determine the propriety of the consent form."

Duty to supervise physicians

"This court has held:

"A hospital has a duty to know the qualifications and the standard of performance of the physicians who practice on its premises. To permit a physician on its staff whom the hospital knows or should have known is unqualified or negligent is a breach of the hospital's duty of due care to its patients.

"To fail to periodically review staff physicians to determine whether they follow hospital procedures and render proper care would be a breach of a hospital's duty to its patients.

"The hospital is not an insurer of a patient's safety, but it owes him a duty of protection and it must exercise a degree of reasonable care towards him as his known condition requires. A hospital can be charged with negligence for failing to review and, in certain instances, supervise the medical care being given under a physician's care within a hospital.' "

The facts alleged in the Lenahan complaint "adequately state a cause of action against the university and hospital for failure to review and supervise the decedent's medical care."

Physician's "special relationship"

"A physician's duty is limited to those situations in which a direct physician-patient relationship exists or there is a special relationship such as when a physician is asked by another physician to provide a service to a patient, conduct laboratory tests, or review test results. Bovara v. St. Francis Hospital, 298 Ill.App.3d 1025, 1030 (1998)."

"By pleading that Dr. Liebowitz provided services to the decedent, conducted laboratory tests, and reviewed test results, plaintiff sufficiently pleaded a special relationship between Dr. Liebowitz and the decedent. Dr. Liebowitz' active role in the decedent's care distinguishes this case from Reynolds v. Decatur Memorial Hospital, 277 Ill.App.3d 80 (1996), and Gathings v. Muscadin, 318 Ill.App.3d 1091 (2001).

"In Reynolds, the appellate court found no special relationship where a doctor gave an informal opinion at the request of the treating physician, but otherwise provided no other services for the patient. In Gathings, the appellate court found no special relationship where the doctor declined to consult with the treating physician about the patient.

"Unlike Reynolds and Gathings, the plaintiff here has pleaded that Dr. Liebowitz performed a myriad of services for the decedent, e.g., he enrolled the decedent in Protocol 8558, drafted the consent form signed by the decedent, directed doctors in administering chemotherapy and collecting T-cells from the decedent, analyzed the T-cells that were collected as part of the decedent's treatment, and grew and expanded the decedent's T-cells.

"This case is similar to Bovara, in which the appellate court held that a physician-patient relationship could be found where the doctors consulted with the decedent's treating physicians, examined his angiogram, and recommended angioplasty.

"Similar to Bovara, plaintiff pleaded here that Dr. Liebowitz directed doctors in their treatment of the decedent, performed laboratory tests and examined test results. Dr. Liebowitz' conduct was sufficient to establish, at this preliminary pleading stage, a special relationship and corresponding duty toward the decedent.

"Defendants argue that no special relationship existed, because Dr. Liebowitz never personally met with the decedent. Defendants' argument is unavailing, as a special relationship may exist even in the absence of any meetings between the physician and patient, where the physician performs services for the patient.

"As discussed, Dr. Liebowitz performed many services for the decedent; accordingly, plaintiff has sufficiently pleaded a special relationship between Dr. Liebowitz and the decedent.

"Defendants also argue that no special relationship existed because Dr. Liebowitz did not provide any services unique to the decedent, but instead performed the same services for all the members of Protocol 8558. Defendants cite no authority for their proposition that a special relationship only exists where the physician performs services unique to the patient.

"The special relationship turns, not on the uniqueness of the services provided, but rather on whether such services are sufficient to impose a duty on the physician. Here, as discussed, plaintiff has pleaded sufficient services to establish, at the pleading stage, a special relationship and corresponding duty from Dr. Liebowitz to the decedent."

Lenahan's "fifth amended complaint states a cause of action for negligence against Dr. Liebowitz, as it adequately alleges a special relationship and corresponding duty between Dr. Liebowitz and the decedent, breach of duty, proximate cause, and damages."

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