Appeal from the Circuit Court of Kane County. Nos. 88-L-33, 91-L-43. Honorable Michael F. O'Brien, Judge, Presiding.
Presiding Justice McLAREN delivered the opinion of the court: Inglis and Geiger, JJ., concur.
The opinion of the court was delivered by: Mclaren
PRESIDING JUSTICE McLAREN delivered the opinion of the court:
The plaintiff, Richard Kus, brought suit against the defendants, Sherman Hospital, Dr. Gordon Vancil, Americal International Corporation (Americal), and Surgidev Corporation (Surgidev), alleging negligence and medical battery relating to the implantation of intraocular lenses. The plaintiff entered into settlement agreements with Dr. Vancil, Americal, and Surgidev, and they are no longer parties to these proceedings. Kus' suit against Sherman Hospital proceeded to a jury trial, where the trial court granted a partial directed verdict for the hospital, dismissing a count charging the hospital with medical battery and a count charging the hospital with negligence in failing to respond adequately to a product recall involving the lens manufactured by Americal. A third count, based upon a negligence theory of lack of informed consent, went to the jury, which rendered a verdict for the hospital. The plaintiff appeals. We affirm in part, reverse in part, and remand.
Prior to the plaintiff's intraocular lens implantations, pursuant to the medical staff bylaws of Sherman Hospital, an Institutional Review Board (IRB) was established at the hospital to protect the rights of patients who were human subjects of research. One of the functions of the IRB was to "require that a legally effective informed consent is obtained prior to conducting a research project." The bylaws of the IRB gave it "purview over all research or investigative activities" and reserved the right to "review the progress of all continuing studies * * * for the purpose of safeguarding the rights of human subjects." Dr. Richard Fiedler chaired the Sherman IRB from 1978 to 1984 and testified that the purpose of the IRB was to make sure that the patient who was undergoing the procedure knew what he was getting into. Fiedler agreed that the IRB had the power to stop unsafe investigative practices. Specifically, Fiedler admitted that the IRB could stop a doctor from using consent forms which were not approved under the protocol for that specific research.
On March 5, 1980, Fiedler, on behalf of the IRB, issued a directive to all operating eye surgeons, including Dr. Vancil, which stated that "the original or a copy of the Informed Consent Form be on the chart of each patient undergoing an intraocular lens implant." On June 4, 1984, Fiedler issued a second directive to the same group of surgeons, which specified:
"It is * * * mandatory that prior to the insertion of one of these lenses that the hospital have a copy of the informed consent signed by the patient so that the lens can be implanted. Without the hospital's having the informed consent in its possession prior to the surgery, the surgery will not be allowed."
The consent form referred to was the FDA-approved consent, detailed below.
The plaintiff's vision began to deteriorate in 1984, and he first went to see Dr. Vancil in January 1985. Vancil recommended cataract surgery and a lens implant, which, he allegedly told Kus, were "quite safe." Kus testified that Vancil never told him that the lens Vancil intended to implant was under investigation for safety and effectiveness. Indeed, Vancil gave Kus a booklet which described intraocular lens implant surgery as a "tried and true method" of vision correction after cataract surgery. Prior to surgery, in Vancil's office, Kus was presented with an informed consent document to read over and sign, which Kus did. The informed consent document which Kus signed had been modified from the FDA-approved and Sherman IRB-sanctioned consent form by the removal of a paragraph on "clinical investigation," which was meant to inform the patient that the lens was under investigation for safety and efficacy. The consent form which Kus signed was then placed in his chart at Sherman Hospital. Eye surgery proceeded on July 15, 1985. Kus entered the operating room at 9:55 a.m., and surgery commenced at either 10:20 or 10:30 a.m., ending at 11:30 a.m. Vancil implanted an intraocular lens manufactured by Americal into Kus' left eye. On that same day, July 15, 1985, a letter from Americal arrived in the office of the president of the hospital, John Graham. The letter was addressed to the IRB chairperson and indicated that, by order of July 3, 1985, the FDA had withdrawn Americal's investigational device exemption for a number of lenses, including the type implanted in Kus' left eye, and stated that, "FDA has ordered that further implantations of Americal's IOLs be stopped and returned to Americal as soon as possible." There was no evidence presented as to the time the letter was actually received. Graham testified that if mail is not addressed to him but to the IRB chairperson, it could be received by his office as late as 3 or 4 p.m. Graham's secretary typically opens the mail and distributes it, and sometimes Graham's secretary does not open the mail until the afternoon. Graham further testified that he did not think his secretary would have opened the mail, or have taken appropriate action with regard to the recall letter, within half an hour of receiving it.
When the plaintiff's vision deteriorated in his right eye, Vancil again recommended the implantation of an intraocular lens, this time one manufactured by Surgidev, which at that point had not been recalled. When Kus questioned Vancil as to why Vancil did not recommend the Americal lens for the right eye, Vancil responded that Americal "did not keep up with their paperwork." Surgery on the right eye commenced on January 15, 1986, with allegedly no consent form in Kus' hospital chart. Kus claimed he signed the consent form 2 to 10 days after the surgery, and the form then appeared in his hospital chart. Similar to the form for the surgery on Kus' left eye, the consent form for the right eye surgery was also modified, and the form made no reference to the fact that the lens was being evaluated for safety and effectiveness.
A receptionist for Dr. Vancil testified that the reason the informed consent forms were missing the section on "clinical investigation" was that Vancil directed the office staff to remove language from the consent form approved by Sherman Hospital's IRB because "he didn't want it on there." This removal was done for all of Vancil's 43 patients who underwent intraocular lens surgery at Sherman Hospital. A subpoena was issued for Dr. Vancil to testify, but it was returned not served.
The Medical Device Amendments of 1976 (MDA) to the Food, Drug and Cosmetic Act of 1938 authorize the Secretary of Health and Human Services to promulgate a regulatory scheme for the clinical investigation of experimental devices under an investigational device exemption. (21 U.S.C. § 301 et seq. (West 1994).) The purpose of such exemptions is:
"To encourage, to the extent consistent with the protection of the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose." 21 U.S.C. § 360(j)(g)(1) (West 1994).
In the year following the enactment of the MDA, the FDA issued regulations providing for "Investigational Exemptions for Intraocular Lenses." (21 C.F.R. § 813.1 et seq. (1993).) The regulations detail the application process by which intraocular lenses can be implanted into human subjects. Under the terms of the regulations, Sherman Hospital was an "institution," which is defined as a hospital which "engages in the conduct of research on human subjects." (21 C.F.R. 813.3(i) (1993).) The IRB of an "institution" is charged with the ...