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Hospital LIability for Medical Research Studies

By Amy J. Kolczak and Melissa Phillips Reading
December 21, 2007

Your hospital and physicians have the opportunity to conduct a study on a new method for the early detection of a disease. They go through the necessary procedures of obtaining patients at risk for the disease, and those patients knowingly agree to participate in the program. However, there may be one problem with this scenario. According to a recent case out of New York, your hospital and physicians may have just established a hospital-patient and/or physician-patient relationship with each of the study participants, exposing all of them to the risk of multiple medical malpractice lawsuits.

New York Case Causes Concern

This most recent case on the issue of hospital and physician liability for test-subject injury is Sosnoff v. Jackman, 845 NYS2d 391 (N.Y.A.D. 2 Dept., 11/07/07). In Sosnoff, the plaintiff had a family history of ovarian cancer. In May 1996, she enrolled in a research study conducted at White Plains Hospital Center concerning early detection of ovarian cancer in patients with a family history of such cancer. As part of the research study protocol, Ms. Sosnoff reported to the hospital approximately every six months for five years for physical examinations performed by the doctors and for diagnostic tests, including ultrasounds and sonograms. Toward the end of the study, in February 2001, Ms. Sosnoff was diagnosed with Stage 3C uterine or endometrial cancer with involvement of the ovaries and lymph system. Ms. Sosnoff filed suit alleging that the hospital and two physicians who participated in conducting the study had negligently failed to diagnose her cancer in its earlier stages.

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