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Medical Device Sales Representatives in the Operating Room: Source of Potential Litigation

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In 1997, a 30-year-old woman died following a routine ambulatory surgical procedure to remove uterine fibroids. During the procedure, a new device was being utilized by the medical staff with the manufacturer’s representative present in the operating room. The new device delivered 9000 milliliters of saline to the patient, with only 1,100 milliliters of output. The consequences were fatal and she died from the excessive infusion and absorption of saline. This incident garnered national notoriety because of the issues as to the propriety of the manufacturer’s sales representative’s presence in the operating room, and led to questions as to what role, if any, he played during the procedure. The public outrage over this incident led to both civil and criminal investigations, new legislation and new hospital policies on this issue.

Medical device manufacturers’ representatives many times observe operating room procedures where their devices are being used. This may come in many forms: the sales representative may be in the operating room, observing the procedure or perhaps providing technical input to the surgeon; or the representative may visit the patient after the procedure to test the functioning of the device. Although this practice is still commonplace in hospitals across the country and may, at first glance, appear to benefit the patient, numerous concerns about a patient’s privacy, informed consent and the unauthorized practice of medicine have arisen. Frequently, company representatives are present in the operating room and the patient either has no knowledge of that fact, or the patient has signed only a “general” consent, not one that advises the patient of the presence of the company representative. Because the operating room likely constitutes a private place, a plaintiff may have a cause of action for invasion of privacy by the mere presence in the operating room of a company representative, unless specific informed consent has been given.

Likewise, a company representative’s presence in the operating room can also be construed as the unlawful practice of medicine. Each state defines the “practice of medicine.” Whether or not the representative has violated the restrictions on the practice of medicine, is a question of fact. Did the sales representative use the medical tool during a surgical procedure? Did he provide advice and consultation to the physician during the procedure? Did the representative change the settings on the device mid-procedure in an effort to assist the physician? Or more simply, did he invade the profession by actions typically provided only by a trained and knowledgeable medical practitioner? The discovery that a sales representative performed these activities may give rise to liability against the sales representative, the device manufacturer, the physician/surgeon and the hospital or facility in which the procedure took place.