Scott Siegner, Associate, LeClairRyan11.07.17
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.
In the Medtronic case, the manufacturer and its sales rep raised preemption as a counterargument to the plaintiff’s claims. Many defendant sales reps try to avoid liability by claiming federal preemption under the Medical Device Act to the Federal Food, Drug, and Cosmetics Act. Citing the doctrine of preemption, courts have dismissed cases involving injuries or deaths that were caused by insufficiencies in the design, labeling, or manufacture of medical devices rather than by operating room conduct. The court in Medtronic’s case, however, allowed the claims to proceed because the allegations related to oral representations made by the manufacturer’s sales reps during a procedure. The case did not involve defective manufacturing or labeling.
The patient in Medtronic’s case died after doctors implanted a faulty pacemaker lead. Technicians on call who were advising the sales rep allegedly failed to identify and advise the physician of a known defect in the lead. The judge, referring to the Adkins case, determined the manufacturer had a duty to provide technical support.
Medtronic volunteered to provide technical support; by doing so, the company assumed a duty to provide that support in a reasonable and prudent manner. Accordingly, medical device manufacturers should not rely on federal preemption as a catchall that effectively bars liability because the courts will now likely scrutinize cases to determine whether sales reps assume a duty to warn doctors of product defects. If such a duty is recognized by the courts, preemption will not protect the device manufacturer from liability.
In both the Adkins and Medtronic cases, the courts left open the question of the precise scope of duties that manufacturers’ sales reps can assume, but these lawsuits certainly suggest those duties can give rise to liability under the right circumstances. Another case, Zappola v. Leibinger, demonstrates what can happen when a jury considers a device rep’s liability. The physician in Zappola filled a defect in the patient’s skull with bone cement; however, the opening was so large that use of a supportive wire mesh was required, as stipulated in the instruction manual. The sales rep allegedly failed to alert the physician about the need for the mesh. Both were found negligent, and the jury reached a $1.7 million verdict for the plaintiff. The Ohio Court of Appeals reviewed the case and determined the sales rep had a non-delegable duty to instruct the physician on proper use of the product at issue.
Fortunately for manufacturers another potential defense—the “captain of the ship” doctrine—can protect against liability. Consider the 2010 Colorado Court of Appeals case O’Connell v. Biomet Inc., which stemmed from the catastrophic installation of a fixator on a patient’s elbow. During the procedure, a bone screw pierced the patient’s radial nerve and wound it up like a fishing reel, ripping a portion of it out of the arm. While the physician claimed he had consulted with the sales rep on the placement of the alignment pin, the sales rep denied it. The court believed the surgeon (i.e., captain of the ship) called the shots and, importantly, there was no evidence the sales rep had acted independently during the surgery. In the O’Connell case, the presumption of physician control and lack of independent action by the sales rep were the key factors in avoiding liability.
No Bright Lines
Case law on sales reps in the OR continues to evolve. In the absence of bright lines, the prudent approach is to be conservative, but also communicative. Be sure your sales reps understand the need to avoid any independent involvement in the medical care being provided and to offer appropriate instruction when required. At the same time, sales reps should feel empowered to speak up when they believe a patient is being put at risk by improper use of a device.
As medical devices become more complex, the line between medical decisions and technical instruction will become increasingly blurred. This trend will continue to present liability concerns as sales reps and technicians are pressed to take a more active role when advising surgical teams. Work with your legal counsel to ensure your playbook on compliance is sound and thoroughly understood at all levels of the organization. Be diligent about how you manage the relationships between surgeons and the “ghosts” in the OR.
Scott Siegner is an associate on the professional liability team at LeClairRyan. Based in the national law firm’s Richmond, Va., office, he frequently represents healthcare clients in medical malpractice cases. He may be reached at scott.siegner@leclairryan.com.
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.
In the Medtronic case, the manufacturer and its sales rep raised preemption as a counterargument to the plaintiff’s claims. Many defendant sales reps try to avoid liability by claiming federal preemption under the Medical Device Act to the Federal Food, Drug, and Cosmetics Act. Citing the doctrine of preemption, courts have dismissed cases involving injuries or deaths that were caused by insufficiencies in the design, labeling, or manufacture of medical devices rather than by operating room conduct. The court in Medtronic’s case, however, allowed the claims to proceed because the allegations related to oral representations made by the manufacturer’s sales reps during a procedure. The case did not involve defective manufacturing or labeling.
The patient in Medtronic’s case died after doctors implanted a faulty pacemaker lead. Technicians on call who were advising the sales rep allegedly failed to identify and advise the physician of a known defect in the lead. The judge, referring to the Adkins case, determined the manufacturer had a duty to provide technical support.
Medtronic volunteered to provide technical support; by doing so, the company assumed a duty to provide that support in a reasonable and prudent manner. Accordingly, medical device manufacturers should not rely on federal preemption as a catchall that effectively bars liability because the courts will now likely scrutinize cases to determine whether sales reps assume a duty to warn doctors of product defects. If such a duty is recognized by the courts, preemption will not protect the device manufacturer from liability.
In both the Adkins and Medtronic cases, the courts left open the question of the precise scope of duties that manufacturers’ sales reps can assume, but these lawsuits certainly suggest those duties can give rise to liability under the right circumstances. Another case, Zappola v. Leibinger, demonstrates what can happen when a jury considers a device rep’s liability. The physician in Zappola filled a defect in the patient’s skull with bone cement; however, the opening was so large that use of a supportive wire mesh was required, as stipulated in the instruction manual. The sales rep allegedly failed to alert the physician about the need for the mesh. Both were found negligent, and the jury reached a $1.7 million verdict for the plaintiff. The Ohio Court of Appeals reviewed the case and determined the sales rep had a non-delegable duty to instruct the physician on proper use of the product at issue.
Fortunately for manufacturers another potential defense—the “captain of the ship” doctrine—can protect against liability. Consider the 2010 Colorado Court of Appeals case O’Connell v. Biomet Inc., which stemmed from the catastrophic installation of a fixator on a patient’s elbow. During the procedure, a bone screw pierced the patient’s radial nerve and wound it up like a fishing reel, ripping a portion of it out of the arm. While the physician claimed he had consulted with the sales rep on the placement of the alignment pin, the sales rep denied it. The court believed the surgeon (i.e., captain of the ship) called the shots and, importantly, there was no evidence the sales rep had acted independently during the surgery. In the O’Connell case, the presumption of physician control and lack of independent action by the sales rep were the key factors in avoiding liability.
No Bright Lines
Case law on sales reps in the OR continues to evolve. In the absence of bright lines, the prudent approach is to be conservative, but also communicative. Be sure your sales reps understand the need to avoid any independent involvement in the medical care being provided and to offer appropriate instruction when required. At the same time, sales reps should feel empowered to speak up when they believe a patient is being put at risk by improper use of a device.
As medical devices become more complex, the line between medical decisions and technical instruction will become increasingly blurred. This trend will continue to present liability concerns as sales reps and technicians are pressed to take a more active role when advising surgical teams. Work with your legal counsel to ensure your playbook on compliance is sound and thoroughly understood at all levels of the organization. Be diligent about how you manage the relationships between surgeons and the “ghosts” in the OR.
Scott Siegner is an associate on the professional liability team at LeClairRyan. Based in the national law firm’s Richmond, Va., office, he frequently represents healthcare clients in medical malpractice cases. He may be reached at scott.siegner@leclairryan.com.