Answer: With today’s high-tech surgical equipment and the wide array of options available to surgeons, in the clinical setting, it is often advantageous for both the manufacturer of a medical device and the doctors who will be using the medical device to have device sales representatives (“reps”) present and available. These reps are well-trained by companies on the technical aspects and the operation of these medical devices and serve as a valuable source of information to the doctor and the medical team in the course of an operation or procedure. These reps often have the benefit of having seen the device utilized in hundreds of procedures.
However, if an adverse event occurs in the course of an operation and a patient is injured everyone present in the OR, including the medical device rep, may be sued by the patient. The chance that sales reps and device companies are named as defendants in a law suit exponentially increases if the device is alleged to have played a role in injuring the patient. Whether sales reps may be liable for injury occurring to a patient is usually a question of fact to be decided by a jury and depends on the nature of the acts that were actually performed by the reps. If the presence of the sales reps was only to provide the ordered device and back-up devices to the medical team in the OR and/or if the rep provided information to the surgical team completely consistent with the FDA approved device labeling, the rep may be insulated from liability. It is when the sales reps provide information about the features or use of the device that is inaccurate or outside of the FDA-approved device labeling or when their acts or advice can be characterized as the practice of medicine or medical decision-making that the sales reps’ liability exposure is greatest.
However, determining the circumstances in which sales reps may be deemed to be practicing medicine is not always easy or obvious. Statutes which address what constitutes the unauthorized practice of medicine are creatures of state law, and thus vary throughout the country. Many states provide little or no definition and others describe it only generally, defining the unauthorized practice of medicine as “professing to practice or prescribe,” “treating or professing to treat,” or “diagnosing, suggesting or recommending remedies.”
In order to ensure that sales reps’ activities fall outside these definitions, and thus minimize the potential liability inherent in sales reps’ presence in clinical settings, medical-device companies should provide training and written procedures to guide sales reps who will be present during a healthcare professional’s use of the device. These behavioral guidelines should be aimed at maintaining the strictest distinction between the sales rep’s intended role as an interactive user manual on the device versus that of an assistant to the doctor in the treatment of the patient.
For instance, in the case of certain implantable devices sales reps should educate the doctor about the range of available models and sizes in the product line they are selling and about the characteristics of each, and then allow the doctor to make the ultimate decision about which particular size and model is appropriate for use in their patient. If, in order to recommend the range of potentially appropriate devices sales reps must know the measurements of a patient’s anatomy, the reps should always require doctors to measure independently and to record those measurements in writing. If doctors elect to use the company device off-label, the company should have doctors sign a form indicating that they are aware that the proposed use is off-label. Finally, reps should be in the OR at the request of the surgeon, or to comply with surgeon-monitoring that may be required by the FDA. Sales reps should not scrub-in or have direct patient contact. Instead, all of their activities need to be monitored and supported by the doctor.
Because of the differences in medical devices, companies should carefully examine their own products and unique circumstances, and consult experts if necessary, to develop well-crafted and relevant policies to guide their sales reps in their interactions with doctors during product training, during the device selection process, and especially in the OR – to prevent them from unknowingly engaging in the unauthorized practice of medicine.