Kus v. Sherman Hospital

Appellate Court of Illinois
644 N.E.2d 1214, 206 Ill. Dec. 161, 268 Ill. App. 3d 771 (1995)

ELI5:

Sections

Rule of Law:

While hospitals generally do not have a duty to obtain informed consent from patients, a hospital that participates in a federally regulated clinical investigation assumes an independent legal duty to ensure that patients provide informed consent using specific FDA-approved protocols.

Facts:

Sherman Hospital established an Institutional Review Board (IRB) to oversee research on human subjects, requiring FDA-approved consent forms for experimental procedures pursuant to federal bylaws.
Dr. Vancil, an eye surgeon, modified the hospital's approved consent forms for his patients by removing the specific section disclosing that the intraocular lenses were experimental and under investigation for safety.
Plaintiff Richard Kus sought treatment from Dr. Vancil, who recommended lens implants but allegedly did not verbally inform Kus that the lenses were experimental.
Kus signed the altered consent forms and underwent surgery on his left eye in July 1985 and his right eye in January 1986 at Sherman Hospital.
On the morning of the first surgery, a recall notice for the specific lens arrived at the hospital's mailroom, though there was no evidence it was opened or processed before the surgery began.
The implanted lenses allegedly caused Kus to suffer permanent eye damage and vision difficulties.
Kus subsequently discovered that the consent forms in his medical chart had been altered to hide the experimental nature of the procedure.

Procedural Posture:

The plaintiff sued the hospital, the doctor, and the manufacturers in the Circuit Court of Kane County for negligence and medical battery.
The plaintiff settled with the doctor and manufacturers, leaving the hospital as the sole defendant.
The case proceeded to a jury trial against the hospital.
The trial court granted a partial directed verdict in favor of the hospital, dismissing the medical battery count and the negligence count regarding the product recall.
The jury returned a verdict in favor of the hospital on the remaining negligence count regarding lack of informed consent.
The plaintiff appealed the directed verdicts and the jury verdict to the Appellate Court of Illinois.

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Issue:

Can a hospital be held liable for medical battery and negligence based on a lack of informed consent when it participates in a federally regulated clinical investigation of an experimental medical device?

Opinions:

Majority - Presiding Justice McLaren

Yes, holding that the hospital assumed a specific duty to ensure informed consent was obtained because of its participation in a clinical study. The court reasoned that while the general rule in Illinois is that hospitals are not liable for a physician's failure to obtain consent, an exception exists when a hospital becomes a "participating institution" in a federal research protocol. By establishing an Institutional Review Board (IRB) and agreeing to FDA regulations, Sherman Hospital affirmatively undertook the responsibility to safeguard human subjects and ensure specific, unaltered consent forms were used. The court also held that federal medical device laws did not preempt state tort claims regarding informed consent because such claims do not regulate the safety or efficacy of the device itself. Finally, the court ruled that the existence of a duty is a question of law for the judge, not a question of fact for the jury, finding the trial court's jury instructions erroneous.

Analysis:

This decision creates a significant exception to the general rule that hospitals are not responsible for obtaining informed consent. By linking hospital liability to the institution's role in overseeing clinical trials and adherence to FDA regulations, the court expanded the scope of corporate negligence and medical battery. It clarifies that when a hospital hosts experimental research, it cannot act merely as a venue but must actively police compliance with research protocols. Furthermore, the ruling clarifies the limits of federal preemption under the Medical Device Amendments, establishing that state tort claims focused on patient autonomy and consent are preserved even when the medical device involved is federally regulated.

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