Human Research Studies and Medical Malpractice Liability

However, while defendants apparently have no trepidations about making such an argument to a court, query whether they will be willing to tell a jury that they owed no duty to patients for whom they were caring because it was done pursuant to a study.

Thomas A. Moore is senior partner and Matthew Gaier is a partner of New York's Kramer, Dillof, Livingston & Moore. This article first appeared in the New York Law Journal, a sister publication of this newsletter.

We have written previously about affirmative treatments that are novel or still under investigation, the special rules applicable to such human experimentation, and the circumstances under which it may result in liability. More recently, we had an experience in a case involving a related circumstance ' not affirmative experimental treatment, but a human research study regarding modes of diagnosis.

The plaintiff in that case participated in a program for the early detection of cancer. She developed cancer while in the program, but those conducting the program failed to make the diagnosis. She claims that tests and examinations administered pursuant to the program should have led to the cancer being caught at an earlier stage.

'Sosnoff': Studying Diagnosis Modes

The claim in Sosnoff v. Jackman seemed like a fairly straightforward, run-of-the-mill malpractice claim for failure to timely diagnose. However, two defendants involved in the program did not see it that way. Because the program they were working under was attempting to study the efficacy of various tests in the early detection of cancer, they asserted that there was no physician-patient relationship and that they could not be held liable for their failure to make the diagnosis. The defendant moved for summary judgment, which led to an appeal. The Appellate Division found that there were questions of fact to be resolved by a jury with regard to the existence of a physician-patient and a hospital-patient relationship. See Sosnoff v. Jackman , 45 AD3d 568 (N.Y.A.D. 2d Dept., 2007). The pivotal issue was whether the patient reasonably expected to receive medical services to benefit her health by participating in the program.

It all began when the plaintiff, then 48 years old, learned about a program being conducted at a local area hospital regarding the early detection of ovarian cancer. She had a history of tumors, which were removed from each of her ovaries when she was 21 years old. Her mother died of ovarian cancer and her maternal grandmother died of what had been termed “women's cancer.” Based upon this history, she was at high risk for ovarian cancer and was accepted into the program.

The program was part of a larger study coordinated by Yale University. White Plains Hospital Center was the local facility administering the study in Westchester County, NY. The study involved tests to predict and diagnose cancer in the body. The tests included transvaginal sonograms, blood tests, including CA125 tests, and fecal stool samples, as well as regular gynecologic examinations.

At the initial meeting, the plaintiff filled out a lengthy questionnaire titled “White Plains Hospital Center's Early Ovarian Cancer Detection Program,” and signed a four-page consent form, which described the program. The consent form indicated that the purpose of the study was “to identify screening tests that [would] allow physicians to diagnose ovarian cancer in its earliest stages before it [was] symptomatic and when it [was] associated with a higher survival rate.” It stated that the data obtained might identify which women would benefit from prophylactic removal of their ovaries to avoid ovarian cancer, and informed participants that they would be told if the data indicated that they would benefit from such removal.

The risks and benefits section of the form advised participants, “The benefit for participating in this study is that if you should have the misfortune of having an ovarian cancer develop while you are participating in this study, it is more likely that ovarian cancer would be identified earlier than if one waited until symptoms developed or followed the usual examination procedures available in the community for identifying ovarian cancer.”

The plaintiff testified that when she entered the program she understood that she would be kept under frequent enough surveillance with the latest techniques for an early diagnosis of cancer, if it developed. Once in the program, the plaintiff called the hospital every six months to obtain appointments for sonograms, examinations and tests. The program eventually expanded in scope to include all hereditary female cancers, and the name changed to the “Female Familial Cancer Syndrome Early Detection Program.” At that point, the program began to include regular mammograms as well.

While the plaintiff was in the program, she underwent six transvaginal ultrasounds that were interpreted as normal by the defendant radiologist. The plaintiff testified that after each ultrasound, the doctor told her that everything looked OK. While still in the program, and some five months after her last set of examinations and tests, the plaintiff was diagnosed by her gynecologist with Stage III cancer involving her uterus and ovaries. The plaintiff sued.

After discovery was complete, the hospital and the radiologist moved for summary judgment, arguing that they had no physician-patient relationship with the plaintiff because the diagnostic tests they administered were only for the purpose of the study and not for her care and treatment. Alternatively, they argued that all claims arising more than 2 1/2 years before the action was commenced should be dismissed as time-barred. The hospital, for its part, asserted that the physicians associated with the study were not its employees, and it therefore could not be held vicariously liable.

Consent Form, Deposition Testimony

The plaintiff opposed the motion for summary judgment on the grounds that the consent form and her own deposition testimony established that she took part in the program specifically to obtain the benefit of the early detection of cancer and that she was under the continuous care of the hospital and the medical personnel it assigned to monitor her for cancer.

The trial court denied the motion as to the radiologist, finding questions of fact as to the existence of a physician-patient relationship and continuous treatment. However, it dismissed the case against the hospital, finding that it did not employ the doctors and that it could not be held vicariously liable for their negligence.

Applying Payette v. Rockefeller University

Both sides appealed. The defendants premised their argument that there was no physician-patient or hospital-patient relationship on the First Department's decision in Payette v. Rockefeller University , 220 AD2d 69 (N.Y.A.D. 1996). That decision addressed the question of whether an action stemming from injuries sustained by the subject of a medical experiment sounded in negligence or malpractice. The plaintiff in that case was a student who participated in an experimental diet study, during which she received a series of iodine injections. After the study ended, she experienced problems and was eventually diagnosed with an enlarged thyroid and hypothyroidism. She commenced a lawsuit nearly three years after the experiment ended. The trial court dismissed the suit on the ground that the 2 1/2-year statute of limitations applicable to medical malpractice actions had expired. The Appellate Division reversed, finding that the Payette plaintiff's claim sounded in negligence rather than malpractice and, therefore, was timely. In so holding, the court found that there was no physician-patient relationship because the plaintiff did not undergo the procedures complained of as part of any medical treatment. It noted that the plaintiff was a healthy 27-year-old woman who never sought any diagnosis or treatment of a medical condition from the defendant, and that there was no allegation that she sought or expected to receive treatment when she was recruited as a volunteer in the program.

The plaintiff in Sosnoff argued that Payette was inapplicable because she was at high risk for ovarian cancer and sought treatment through the program in the form of monitoring and surveillance for the development of cancer. The plaintiff relied on her deposition testimony and the consent form, particularly on the representation in the form that the benefit for participating in the study was that if a participant developed cancer it would more likely be identified earlier. Based on this evidence, the plaintiff argued, her entry into the program established a hospital-patient relationship with White Plains Hospital, and physician-patient relationships with each of the physicians who treated her pursuant to the program.

The Appellate Division, Second Department, found that the evidence established issues of fact as to the existence of the relevant relationships. It found that the lower court correctly determined that there was an issue of fact as to whether a physician-patient relationship arose as a result of the radiologist's interpretation of the sonogram films. It specifically found an issue “as to whether the sonograms performed on the plaintiff pursuant to the protocol for the cancer-detection research study were also prescribed to monitor her condition as a patient at high risk for ovarian cancer.”

Patient Not Merely a Subject

As to the hospital, the court held that the trial court erred in determining that the hospital established the absence of any hospital-patient relationship. There was evidence in the record that when the plaintiff agreed to participate in the research program, she was not merely a subject or control person ( see Payette v. Rockefeller University , 220 AD2d 69, 72 (NY 1996)). Rather, she expected to receive medical treatment and services, and she reasonably accepted services from the physicians to whom she was assigned with the expectation that proper professional skill would be employed and that she could rely upon them for a proper diagnosis of her condition if she developed a malignant condition during the time they were regularly examining her. See Bradley v. St. Charles Hosp. , 140 AD2d 403, 404 (NY 1988); Raptis-Smith v. St. Joseph's Med. Ctr. , 302 AD2d 246, at 247 (N.Y.A.D. 1 Dept.,2003).

The Appellate Division also found issues of fact as to continuous treatment, and the hospital's vicarious liability for the physicians who treated the plaintiff pursuant to the doctrine of ostensible agency. However, it found no evidence that the hospital or its staff were directly negligent.

Sosnoff is significant because it recognized that health care providers may not be absolved of liability as a matter of law for a negligent failure to diagnose a condition merely because the diagnosis or treatment was undertaken in the course of a human research study. It could not seriously be argued that there would be no liability if the patient had been affirmatively injured by negligence of the hospital or doctors in the course of the study, as was the participant in Payette.

In fact, the finding of no physician-patient relationship in Payette did not absolve the defendants of liability, but only meant that they were liable for simple negligence rather than malpractice. The only reason liability became an issue in Sosnoff was that it involved a failure to diagnose, which generally requires the existence of a physician or hospital patient relationship in order for the health care provider to owe a duty of care. Evidence that the patient was intended to benefit by way of diagnosis or detection as a result of her participation in the study is the key to liability in such a situation.

Essentially, it must be established that the patient was relying on the diagnosis or treatment undertaken pursuant to the study for her own health and well-being.

A 'Blind Trial'

Our research revealed one other New York case in which a defendant attempted to use Payette to absolve himself of liability for malpractice in the course of a human research study.

The plaintiff in Clermont-Lundy v. Zimbalist , 10 Misc.3d 1056 (A), 2005 WL 3309753 (Sup. Ct., Kings Co. 2005), claimed that the defendants were negligent in failing to diagnose the decedent's colon cancer while he was participating in a clinical trial of a drug to treat Crohn's disease. The study involved a “blind trial,” and the defendant doctor did not know whether the decedent was actually receiving the drug or a placebo. Pursuant to the protocol, the doctor evaluated and monitored the decedent throughout the time he was involved in the trial. When the decedent was admitted to the hospital for abdominal pain, the doctor ordered a CT scan that revealed densities and raised a question of metastasis.

After discharge, the decedent continued to see the doctor for follow-up visits regarding the trial and the hospitalization. Less than four months after his last visit with the doctor, the decedent was diagnosed with metastatic cancer and died within a week. Relying on Payette, the doctor moved for summary judgment, arguing that there was no physician-patient relationship. In rejecting that argument, the court found that the decedent suffered from a condition ' Crohn's disease ' and that the clinical drug trial for which the doctor came to examine and monitor him was specifically contemplated for that condition. Therefore, the court found that there existed issues of fact as to whether there was a physician-patient relationship, or at least an implied physician-patient relationship.

Telling Jury: 'No Duty Owed'

The argument by the defendants in Sosnoff and Clermont-Lundy represent creative efforts to absolve themselves of liability. If successful, the defendants' argument would mean that even if they departed from proper practice, they could not be held liable because they owed the study participants no duty of care. The defendants remain free to make the argument to the jury, since the courts in each case only found that there existed issues of fact, and did not hold that there was a physician-patient relationship as a matter of law.

However, while defendants apparently have no trepidations about making such an argument to a court, query whether they will be willing to tell a jury that they owed no duty to patients for whom they were caring because it was done pursuant to a study.

Thomas A. Moore is senior partner and Matthew Gaier is a partner of New York's Kramer, Dillof, Livingston & Moore. This article first appeared in the New York Law Journal, a sister publication of this newsletter.