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JOHN ANCHEFF v. HARTFORD HOSPITAL ET AL. (SC 16617)
Borden, Norcott, Palmer, Zarella and Tobin, Js. Argued February 13--officially released July 9, 2002

Joshua D. Koskoff, with whom was Joel Faxon, for

the appellant (plaintiff). Frank H. Santoro, with whom was Robert E. Kiley, for the appellee (named defendant). Augustus R. Southworth III, with whom, on the brief, was John R. Horvack, Jr., for the appellee (defendant Jonathan Tress).
Opinion

BORDEN, J. The principal issue in this appeal, taken from the trial court's judgment on a defendants' verdict in this medical malpractice action, is whether the trial court properly excluded from evidence a certain report of a federal commission regarding the protection of human subjects of biomedical and behavioral research.1 The plaintiff, John Ancheff,2 appeals3 from the judgment of the trial court for the defendants, Hartford Hospital (hospital) and Jonathan Tress,4 rendered following the jury verdict in their favor. The plaintiff claims that the trial court improperly: (1) excluded from evidence the Belmont Report; (2) excluded from evidence a certain medical consent form; and (3) instructed the jury on the question of the meaning of medical research. We affirm the judgment of the trial court. The plaintiff brought this medical malpractice action against the hospital for injuries he allegedly had suffered arising out of an improperly administered program involving a drug known as Gentamicin. Insofar as is relevant to the issues on appeal, the plaintiff claimed that the hospital had improperly: conducted clinical trials and study procedures regarding Gentamicin; failed to inform the plaintiff that he was a participant in such a trial or procedure; failed to obtain his informed consent for such participation; and failed to disclose to him the experimental nature of his course of treatment with the drug. After a trial to the jury, a verdict was returned in favor of the hospital. The plaintiff then moved to set aside the verdict, which the trial court denied. This appeal followed. The jury reasonably could have found the following facts. In January, 1993, the plaintiff underwent back surgery, after which he developed a deep wound infection reaching his spinal column. He was admitted to the hospital on February 5, 1993, where Tress was consulted as a specialist in infectious diseases. Cultures disclosed the presence of enterococcus, a difficult bacteria to eradicate. Because Tress suspected enterococcal osteomyelitis, a potentially life-threatening form of bone infection, he ordered a course of combined antibiotic therapy of Gentamicin5 and Unasyn. Gentamicin has known nephrotoxic and ototoxic6 effects regardless of how it is administered. Initially, Tress ordered Gentamicin to be administered once a day in a dose of 480 milligrams. Pursuant to an inpatient dosing program previously enacted by

dosage to 615 milligrams.7 Thereafter, Tress examined the plaintiff's condition, and determined that the increased dosage was appropriate. The plaintiff received this combined dosage of drug therapy for approximately twelve days in the hospital. During that time, his kidney clearance and serum levels were monitored for signs of impaired kidney clearance and drug accumulation, with negative results during the plaintiff's stay in the hospital. The plaintiff was discharged from the hospital on February 24, 1993. Tress prescribed a course of home intravenous antibiotic therapy of Gentamicin and Unasyn at the same levels, in order to eradicate the infection. Although the infection was successfully treated, on March 17, 1993, the plaintiff developed side effects from the Gentamicin, namely, vestibular toxicity, or poisonous effects to the inner ear, which resulted in the loss of the functioning of his inner ear, including his sense of balance. The plaintiff claimed at trial that he suffered total and permanent destruction of the functioning of his inner ear due to an excessive administration of Gentamicin. I THE BELMONT REPORT The plaintiff first claims that the trial court improperly excluded from evidence the Belmont Report. Specifically, he claims that he sought to establish at trial that the hospital's program of administering Gentamicin constituted medical research, and that, therefore, the hospital was required to have that program reviewed by an institutional review board and to provide the plaintiff with a detailed written consent form outlining the risks, benefits and alternatives, as well as the experimental nature, of the program.8 The Belmont Report, he claims, supported this claim. We conclude that, as the question was presented to the trial court, the court did not abuse its discretion in excluding the Belmont Report from evidence. In order to analyze this claim, it is necessary to recount, first, the role that the question of medical research played in the trial. At the heart of the plaintiff's case, insofar as this appeal is concerned, was his claim that the hospital's program for administering Gentamicin, known as the once-daily aminoglycoside regimen,9 constituted engaging in medical research. The hospital did not challenge the proposition that, if the Gentamicin program had constituted medical research, such a review and consent form would have been required. It vigorously contested, however, the claim that the program constituted research. The hospital claimed, to the contrary, that it constituted the implementation of a program or practice of medical therapy, which, in turn, was aimed, not at validating an untested theory or hypothesis, but at using the available literature, including prior research and clinical data, for the

improvement of patient care and safety. Thus, whether the Gentamicin program constituted medical research, as claimed by the plaintiff, or the implementation of a therapeutic program for patient care and safety, as claimed by the hospital, was litigated as a question of fact. There was conflicting evidence produced on the question. The plaintiff produced the following evidence tending to prove that the hospital's Gentamicin program constituted medical research. The hospital's program provided for a level dose of seven milligrams per kilogram of body weight (7 mg/kg), a dosage that previously had not been tested on humans. In 1993, the hospital was the only one in the country that prescribed that dosage to entire classes of patients. This dosage departed from the conventional dosage of 3 mg/kg approved by the federal Food and Drug Administration. The hospital had described both the dosage of 7 mg/kg and its method of administration, namely, one daily injection as opposed to the conventional administration of three injections per day, as ``radical.'' In addition, the hospital administered the drug to a class of patients pursuant to a ``protocol,'' which meant that, if a physician failed to prescribe the dosage of 7 mg/kg called for in the protocol, the hospital pharmacist would change the dosage automatically. In publications to the medical community, the hospital had stated that the Gentamicin program was ``a radical change from standard aminoglycoside administration schedules,'' and that ``the [Gentamicin] program was unlike most other hospital-wide programs because it was not a conversion to a therapeutic alternative but, rather, a radical change in both the conventional dosing and administration of the aminoglycosides.'' Data was collected by the hospital on each patient apart from what was kept in the patient's medical record. In addition, the physicians responsible for enacting the Gentamicin program at the hospital, namely, Charles Nightingale, David Nicolau and Richard Quintilliani, lectured to the medical community on the findings of the program. Furthermore, the plaintiff introduced a definition of research contained in the Code of Federal Regulations that was applicable to the hospital. That regulation defined research as ``a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. . . .'' 45 C.F.R.

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