Kus v. Sherman Hospital
Illinois Court of Appeals
644 N.E.2d 1214 (1995)
- Written by Mary Phelan D'Isa, JD
Facts
Richard Kus (plaintiff) sued his doctor, Dr. Vancil, and Sherman Hospital (defendants) for negligence and medical battery for implanting experimental intraocular lenses without first getting his informed consent. Kus alleged violations of the Food and Drug Administration’s (FDA) regulations for investigational devices and the hospital’s bylaws for its Institutional Review Board that was charged with protecting the rights of patients who were human subjects of research. FDA regulations for the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act of 1938 required that specifically worded informed-consent forms be signed by patients and included in patients’ charts before the experimental lenses could be implanted. Dr. Kus modified the FDA-approved forms, removing the clinical investigation information and provided booklets describing the lens surgery as a tried-and-true method of vision correction and cataract surgery. The hospital failed to conduct the required continuing review of research on at least an annual basis that included reviewing the informed-consent process. The trial court granted a directed verdict for the hospital, and Kus appealed.
Rule of Law
Issue
Holding and Reasoning (McClaren, J.)
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