## Facts

- Richard Kus underwent cataract-related eye surgery at Sherman Hospital performed by Dr. Gordon Vancil.
- Vancil implanted intraocular lenses used in an FDA-regulated investigational device study.
- The study required use of IRB- and FDA-approved informed-consent forms disclosing the experimental nature of the lenses and retention of executed consents.
- Kus alleged Vancil altered the approved consent forms to remove “clinical investigation” language and provided materials describing the procedure as standard rather than experimental.
- Kus alleged Sherman Hospital’s Institutional Review Board failed to provide required oversight, including continuing review and adequate supervision of the consent process.
- Kus later developed serious visual problems and claimed he would not have agreed to implantation had he been told the lenses were investigational.
- Kus settled with the surgeon and device manufacturers; Sherman Hospital remained the principal defendant.

## Issues

1. Whether the Medical Device Amendments preempt state-law claims based on lack of informed consent for implantation of investigational devices.
2. Whether the trial court properly directed a verdict for the hospital on Kus’s medical battery claim premised on nondisclosure of the procedure’s experimental nature.
3. Whether the existence and scope of the hospital’s duty to ensure informed consent in the clinical investigation was a question of law for the court, and whether jury instructions improperly left duty to the jury.
4. Whether negligence theories tied to regulatory noncompliance (including recall-related allegations) were viable or preempted.

## Decision

- The appellate court held that MDA preemption did not bar state-law claims focused on informed consent to an investigational procedure.
- The court reversed the directed verdict for the hospital on medical battery, finding evidence from which a jury could conclude Kus did not consent to an experimental procedure.
- The court held the hospital owed a duty, as a matter of law, to ensure proper informed consent due to its role in the clinical investigation and IRB responsibilities.
- The court ruled the trial court erred by treating duty as a jury question and by giving instructions that misframed duty.
- The judgment was affirmed in part, reversed in part, and remanded for further proceedings, including a new trial on the affected informed-consent negligence and battery matters.

## Legal Principles

- Federal medical-device regulation does not preempt traditional state tort duties governing disclosure and consent when the claim targets the consent process rather than device design, manufacturing, or labeling requirements.
- Under Illinois law, medical battery may be shown where a patient consents to a procedure as represented but the provider performs a materially different procedure, including an experimental intervention not disclosed as such.
- A hospital participating in human-subject research, operating through an IRB charged with protecting subjects and overseeing consent, can owe an independent duty to ensure informed consent is properly obtained.
- The existence of a duty is a question of law for the court; jury instructions must not leave duty determination to the jury.
- Regulatory requirements may inform the standard of care for state-law duties, but state theories that effectively impose additional or conflicting device-related requirements may be preempted.

## Conclusion

The court allowed informed-consent-based negligence and medical battery claims to proceed despite federal device regulation, held that the hospital had a legal duty tied to its investigational-study and IRB role, and ordered further proceedings because the trial court improperly removed battery from the jury and mishandled the duty determination and instructions.


Kus v. Sherman Hosp., 268 Ill. App. 3d 771, 644 N.E.2d 1214 (Ill. App. Ct. 1995)