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Company Representatives and Modern Medical Technology

BY Michelle Hart Yeary
August 30, 2012

When we think of sales representatives in the healthcare setting, we typically picture pharmaceutical representatives visiting doctors' offices to distribute samples and promotional materials. In recent years, however, as medical device technology has rapidly advanced, the presence of medical device company representatives in operating and procedure rooms has become increasingly common. Whether representatives attend surgeries to observe uses of the device, to assist the medical staff by making the appropriate supplies available, or to calibrate technical products, their presence can be a benefit to surgeons, companies, and patients alike. However, while company representatives can provide technical support for complex devices and keep surgical staff informed about new technology, their presence in operating and procedure rooms is not without controversy. When things go wrong, patients may use the presence of company representatives to advance theories of liability against device manufacturers that they would otherwise not face.

Theories of Liability

In a small number of cases, a representative's mere presence in an operating or exam room has been enough to expose a manufacturer to potential liability for invasion of privacy. See, e.g., Sanchez-Scott v. Alza Pharmaceuticals, 103 Cal. Rptr.2d 410 (Cal. Ct. App. 2001) (holding that a manufacturer could be held liable for invasion of privacy when a sales representative observed plaintiff's breast examination and was not identified to plaintiff as an employee of defendant). Plaintiffs have also occasionally accused sales representatives of the unauthorized practice of medicine. In one of the oldest and most extreme unauthorized practice of medicine cases, People v. Smithtown General Hospital, 93 Misc.2d 736 (Suffolk County NY 1978), criminal charges were brought against the physicians and hospital where a hip prosthesis company representative participated in a surgery. The court noted that where the representative not only scrubbed in, but, with the surgeon's consent, removed the hip prosthesis and completed the rest of the surgery, a jury could reasonably conclude that he had engaged in the unauthorized practice of medicine. Id. at 739-740; but see Disbrow v. Smith & Nephew Richards Inc., 1996 WL 593780 (Tx. App. Oct. 17, 1996) (granting defendants' motion for summary judgment where a device manufacturer's representative was present during a hip replacement surgery but merely assisted the nurse in locating a tool). Although it was dismissed on statute of limitations grounds, Wilkerson v. Christian, 2008 WL 483445 (M.D.N.C. Feb. 19, 2008), suggests that unauthorized practice of medicine allegations against company representatives persist. See Id. at *11 (“Plaintiff alleged facts ' that raise serious questions regarding the propriety of sales representatives in the operating room. The gravity of Plaintiff's allegation that a sales representative performed, or participated in, [decedent's] tumor ablation procedure is not lost on this court.”).

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