Negligent Failure to Warn: Who Owes the Duty?
The question facing the courts is this: Exactly what does it mean, both practically and legally, to hold that a sales representative—someone commonly with no medical background or training—owes a separate and independent duty to a patient he or she has never (consciously) met? Sales representatives are decidedly not doctors. Their role and responsibility is most often to ensure that the surgeon has the instruments and implants needed for the surgery—a screw, plate, stent, artificial joint, or implantable pump, for starters—and in the proper sizes and configuration. They are supposedly experts on their products, not the surgery. And they are undoubtedly not there to answer questions about how to perform the surgery, or—even worse—to actually perform the surgery itself. Right?
Like most areas of law, the answers to these questions reside in shades of grey. While manufacturers typically require that sales representatives remain outside the sterile field and refrain from interacting with the surgeons in a way that could be construed as "practicing medicine," the reality of what happens in the operating room appears to be less black and white. Sales representatives often have a rapport with the doctors they work with, and it is not uncommon for a surgeon to ask the representative about some nuance of the procedure involving the device. It may even be the case that an experienced representative has attended more surgeries of the kind being performed than a doctor fresh out of residency or fellowship training. In those cases, the representative may be more involved in the surgery than one might assume at first blush.
Despite this reality, the few courts that have considered whether representatives owe a duty to the patient have found an inherent conflict between the alleged duty to instruct, train, and advise a surgeon, on the one hand, and the longstanding learned intermediary rule, on the other. As one court described it, to hold that a manufacturer's representative has an independent duty to the patient would "place the [manufacturer's representative] in the middle of the doctor-patient relationship." Kennedy v. Medtronic, Inc., 851 N.E.2d 778, 784 (Ill. App. Ct. 2006). Indeed, the learned intermediary doctrine adopted in nearly every state exists precisely because manufacturers (and, by extension, their representatives) do not belong in that relationship. Rather, a manufacturer discharges its duty to warn by apprising the doctor of the risks associated with the device. That is exactly what the package insert and other manufacturer's product literature is for. It is up to the doctor, based on his or her education, training, experience, and, of course, the medical history of the patient, to decide whether—and to what extent—he or she should heed that warning. The creation of an independent duty on behalf of the sales representative would be at odds with this nearly universal recognition that it is the doctor, and the doctor alone, who makes medical decisions for the patient, including how and whether to use a medical device.
The underpinnings of these decisions are rooted not only in already existing legal premises (like the learned intermediary doctrine), but also in common sense. Although experienced representatives may know the ins and outs of surgery better than some doctors, courts tend to find that a doctor should not rely on the instructions and advice of those with little to no medical background. They therefore conclude that the mere fact of a representative's presence in the operating room during the surgery does not cloak him or her with the authority or qualifications to advise the surgeon on what to do—and for good reason. Without the years of medical school, residency, and in some cases fellowship training that doctors must have to operate, most courts find that a sales representative is simply unqualified to advise a surgeon on how to treat a patient. For this reason, some courts have stated that it would be "patently unreasonable" for a doctor to rely on the advice of a representative. See Hall v. Horn Med., LLC, No. 11-1032, 2012 WL 1752546, at *3 (E.D. La. May 16, 2012).
Exceptions to the Rule
There are, of course, exceptions. Even courts that have held no independent duty from a representative to a patient exists have, on occasion, concluded that a representative may expose himself or herself to liability for assuming such a duty. For example, the Indiana Court of Appeals found in Medtronic, Inc. v. Malander, 996 N.E.2d 412 (Ind. Ct. App. 2013), that a representative who provided "technical" advice to the surgeon concerning the use of a cardiac ventricular lead may have assumed a duty to the patient by advising the surgeon concerning the lead, but failing to tell the surgeon to replace it (an omission that the plaintiffs claimed resulted in the patient's death). Thus, where the representative's role went slightly beyond just standing in the operating room during the procedure, the court declined to enter summary judgment in favor of the manufacturer (and representative), instead holding that the representative might have assumed a duty to the patient. The existence and extent of such duty were, of course, issues left to the jury.
Surgeon as "Captain of the Ship"
Not surprisingly, what constitutes a sales representative's "advice" to a surgeon is still an open question. Telling the surgeon about the product generally (especially by repeating the manufacturer's written warnings) is one thing. Telling the surgeon how the product can or should be used for a particular patient is quite another. Luckily (for defense lawyers), a somewhat sparing respite from this legal brain teaser exists in the "captain of the ship" doctrine in those jurisdictions that have adopted it. The doctrine provides that in an operating room, the surgeon alone is liable for the acts and omissions of all others in the room, including nurses, surgical technologists, other hospital personnel, and yes—product representatives. It therefore makes no difference whether the sales representative gave advice to the surgeon because, in the end, it is the surgeon who makes the ultimate decision and is potentially liable for any mistakes that occurred during the treatment of the patient. See, e.g., O'Connell v. Biomet, Inc., 250 P.3d 1278, 1280 (Colo. Ct. App. 2010). Under those circumstances, parsing "advice" from simply passing on warnings is, for once, a useless exercise.
To try to limit their exposure in products liability lawsuits, sales representatives should adhere to a few basic rules. First, representatives should closely follow the manufacturer's guidelines for conduct during surgery. This might include advising surgeons only insofar as repeating the manufacturer's warnings and instructions for use, or putting the surgeon in contact with a technical expert at the company for more sophisticated questions. Second, sales representatives must stand where they belong during surgery: outside the sterile field. Anywhere else, and they may be sued not only for assuming a duty to the patient, but also for the unauthorized practice of medicine. Lastly, sales representatives should generally try to stick to what they know best—the product—and stay away from discussing the patient's treatment.
Of course, following these rules may prove more difficult in practice. Therefore, once a lawsuit has been filed and questions arise as to what actually happened in the operating room, counsel for both parties need to do their homework. While it is often difficult for those involved to remember the details of a surgery that took place years earlier, it is crucial that counsel interview (or depose) everyone who was present to see what exactly they do recall. Pretrial prep teams would also be wise to walk the surgeon and representative through the operating room to understand not only what each person was doing during the surgery, but where they were standing, how close they were to one another, whether those other than the surgeon had a clear view of the surgery, and what steps led up to and followed the alleged mistake. After all, understanding these details could determine—or at least raise questions about—who in fact was in control of the "ship": the captain or the crew.
Keywords: litigation, products liability, medical devices, sales representatives, duty to warn, learned intermediary rule, captain of the ship doctrine