Despite being present in the operating room (OR) for many surgical procedures, medical device sales representatives have been fairly insulated from liability arising from the products they promote. These “ghosts” in the OR are legally protected, as the law presumes they take a passive role during surgeries. However, patients and their attorneys increasingly are attempting to navigate around these protections to expose medical device reps to greater liability.
In some ways, this trend appears to be related to the ever-rising interest in healthcare. As the patients have become more sensitive to individuals involved in their care, so too have the courts. Consequently, medical device manufacturers must redouble their efforts to reduce liability risks associated with sales force representation in the OR and on-call technicians.
Holding the Line on Instruction vs. Independence
While the scope of liability appears to vary by case, the general principle for sales representatives is relatively straightforward: Offer informed and accurate instruction to surgeons in the OR, but never fall into the trap of making pivotal decisions for the healthcare professionals. The key is to understand the difference between offering instruction and becoming an independent player in the surgical theater.
Typically, sales reps are present in the OR to help ensure that surgeons are aware of all known risks, and products are used in accordance with their intended purpose. In a perfect world, management could simply tell their sales reps to respect this role and never step outside of it. But the realities of human psychology are seldom so black-and-white.
Surgeons and sales reps often build a strong rapport. This amicable business relationship can develop into a chummy interdependence but there can be a dark side to this bond. The physician, for instance, could become too dependent on the sales rep for all medical device-related decisions.
Ideally, the physician should act as the “captain of the ship” and call all the shots. But either through habit or self-doubt, surgeons can sometimes act upon incorrect or overreaching advice from sales reps. While medtech sales reps possess an expertise in their products, physicians must bear in mind that they are not doctors. They don’t have a medical degree. Thus, sales reps should not offer any kind of medical opinion, and should not act as if they are co-captains of the surgical team.
Key Cases: Reps in the OR
For manufacturers, the lack of clear guidance makes risk management particularly challenging. To date, few courts have provided any bright-line rules. Most of the key cases turn on the specific facts involved. The most important questions center on whether sales reps assume a separate, actionable duty when they involve themselves in pivotal decisions in the OR. If they do, what is the scope of this duty? How will liability be determined moving forward? Consider two cases that illustrate the ambiguity surrounding these questions.
In the 2008 case Adkins v. Cytyc Corp., a federal court in Virginia recognized the plaintiff’s ability to sue for general negligence based upon the medical device sales rep’s assumption of a duty. The plaintiff argued that the sales rep was negligent by instructing the surgeon in the OR. During the procedure, the sales rep allegedly told the surgeon—incorrectly—how to measure the patient’s uterine wall, causing the patient to suffer thermal burns. The court noted that the sales rep had a duty to the patient as a de facto physician’s assistant during the procedure. The claims were ultimately dismissed for lack of detail addressing how the sales rep breached that duty, but the court granted leave to amend the allegations to provide the necessary information.
In contrast, Medtronic Inc. v. Malander demonstrates the risk associated with failing to speak up. Decided in October 2013 by the Indiana Court of Appeals, the case highlights the difficulty encountered when attempting to derive predictable guidelines from existing case law.