Implant manufacturer sales representatives (reps) are a familiar presence in orthopaedic operating rooms (OR), especially during spine surgery and adult reconstructive operations. For some surgeons, a rep’s presence in the OR is essential during surgery to secure and replenish implants, to educate surgeons on new implant designs, and for discussions on how their orthopaedic surgery peers approach the same operation with their implants [2]. Regardless of how surgeons view the utility of reps in the OR, the rep model has come under scrutiny in recent years [2]. For critics, the rep-based system adds cost to an already-expensive system. Financial ties between orthopaedic surgeons and the implant industry have been well publicized, potentially leading to improper conduct by both reps and surgeons that may jeopardize patient safety and welfare [6, 9]. A 2021 investigation published by Kaiser Health News alleged that rep activities like giving surgeons technical advice in the OR about the use of their products or paying surgeons to promote their implants at medical conferences, have caused patient harm; certainly, those activities have been named in lawsuits [9]. Having a rep present in the OR without the patient’s consent can give rise to invasion of privacy claims. In one legal case from 1978 that involved particularly egregious misconduct, a hospital, circulating nurse, sales rep, and orthopaedic surgeon were charged with the crimes of assault and fraud for allowing the rep to scrub in on a hip replacement case, and then neglecting to mention this in the operative note [7]. During the COVID-19 pandemic, many hospitals restricted sales reps from accessing ORs, forcing reps to rely on remote interactions with surgeons instead. As elective surgery resumes, COVID-19 protocols have opened the door for those who want to keep reps out of the hospital entirely, citing unnecessary increased costs and exposure of the patient to increased infection risk from additional people in the OR [9]. These critics argue that hospitals should train their own staff to perform the functions previously covered by sales reps [9]. Although there have been numerous documented examples of inappropriate relationships between surgeons and reps [1, 6, 9], the rep model is backed by decades of legal precedent and is likely here to stay, albeit with a diminished or more defined role in the OR because of hospitals’ COVID-19 protocols. Medical Device Litigation In support of its position, the Kaiser Health News report [9] described a patient’s nerve injury caused during spinal decompression at a Texas hospital. The rep did not have the desired size of a vertebral interbody implant, necessitating implantation of a larger size that was in stock. Four days after the initial surgery, the implant was exchanged for the correct size, but the injury persisted. The lawsuit named the sales rep, among other parties, alleging negligence in not having the right size available. The legal action, according to Kaiser Health News, took direct aim at the sales network that orthopaedic device manufacturers have set up to promote their surgical hardware, and how that network can lead to patient injury from defective or wrong-sized implants [9]. Lawsuits charging surgeons and reps with incorrect implant size selection or improper implantation techniques often name the implant manufacturer as a defendant for negligence in the design, manufacture, or labeling of the device. However, implant manufacturers are generally in a favorable position in such cases because of a legal principle called federal preemption, which itself is based on the Supremacy Clause in the US Constitution. Preemption prohibits state courts from assuming any functions that are exclusively entrusted to the federal government. Since medical devices undergo rigorous review and approval by a federal agency (the FDA), federal preemption works to remove implant-related legal claims out of state courts to federal courts, where the manufacturer can assert FDA-approval status of the device as a defense. The preemption of claims and their adjudication in federal courts makes it hard for injured plaintiffs to recover, while reducing litigation costs and complexity for defendant manufacturers [1]. The Case Law Riegel v Medtronic Inc [8], is an illustrative case of how federal preemption works. Charles Riegel had a serious complication when a cardiac angioplasty catheter made by Medtronic Inc ruptured in his coronary artery. He sued Medtronic for negligence in a state court. Medtronic argued that Riegel could not bring these claims under New York law since they were preempted by Section 360k(a) of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act. The MDA establishes a federal regulatory process for medical device safety, and no state may set requirements that differ from or add to the federal ones. One by one, each of the three levels of US federal courts agreed with Medtronic as the case moved through its appeals. The US District Court, the US Court of Appeals for the Second Circuit, and the US Supreme Court all were of the same mind: If a medical device has undergone premarket approval by federal regulators, allowing state court claims against such devices would be an impermissible violation of MDA’s preemption clause. Medtronic prevailed. Suing the Rep: A Viable Option? Since the Riegel ruling in 2008 [8], implant manufacturers have seen an increase in product liability claims arising from instructions, representations, and omissions of sales reps [1]. There is incentive to name a rep in product liability claims. Litigation that would otherwise be likely preempted by federal law may survive in a state court on the so-called parallel claim exception [5]. Plaintiffs’ lawyers use this workaround strategy to keep the case in the plaintiff-friendly venues of state courts. While courts have yet to define a bright line for when the parallel claim exception applies, the general sense is that the degree of involvement and responsibility of the rep in the OR is important. That said, certain types of claims have a greater likelihood of surviving preemption arguments than others. For example, in the 2011 case, James v Stryker [4], a failed pain pump led to injuries following shoulder arthroscopic surgery. One of the allegations was the promotion of off-label use of the pain pump by the sales rep. Stryker Inc filed a motion to have the lawsuit dismissed. In denying dismissal, the court noted that the rep had actively promoted the use of the pain pump for shoulder surgery, despite knowing that such use was off-label. The James ruling illustrates that the mere presence of the rep in the OR, where off-label use occurs, is not enough to overcome federal preemption. Instead, off-label promotion through actions, words, or even willful silence by the rep can survive preemption. In general, cases involving off-label use of a device are more likely to be successful in adding the rep as a defendant. In contrast, failure-to-warn cases generally end up absolving the sales rep of liability. Courts hold the surgeon solely responsible for reading instructions that come in the implant package and for knowing how to use a medical device correctly. In Hall v Horn Medical [3], decided a year after James, a surgeon implanted a spinal device without a bone graft when the package-insert instructions for use were clear that the device was to be used only with a bone graft. Complications led to a lawsuit, and the rep was named as a defendant, alleging a duty to advise the surgeon about the need for a bone graft. At trial, the surgeon even testified that the rep told him that the device could be used without a bone graft. The Court held that the decision to not use a bone graft was a medical decision, and as such, entirely the responsibility of the surgeon, even if the rep had made a misleading statement about bone graft use. As Hall illustrates, it is not the duty of the rep to warn or advise the surgeon about the proper use of a medical device, or how to perform a procedure. Likewise, the argument that a rep gave medical advice to the surgeon, and thereby engaged in the practice of medicine usually fails. Most court decisions in this area agree that rep statements and advice in the OR do not amount to the unauthorized practice of medicine [1]. Still, if the actions of the rep were egregious enough, it is possible that a court may see things differently, as suggested by at least one legal opinion. In Wilkerson v Christian [10], a surgeon performed radiofrequency ablation of benign liver tumors. During the operation, the radiofrequency generator device was entirely in control of the rep, who operated it under instructions of the surgeon. Complications led to patient death, and while the lawsuit was dismissed on the grounds that the case was brought after the statute of limitations had lapsed, the court was clearly disturbed: “Plaintiff alleged facts, in good faith, that raise serious questions about the propriety of sales representatives in the operating room. The gravity of Plaintiff’s allegations that a sales representative performed, or participated in, (the deceased’s) tumor ablation procedure is not lost on this court” [10]. Discussion Although these legal rulings generally absolve the sales rep, they also suggest that the courts closely scrutinize rep conduct to determine whether there is liability. Accordingly, hospital staff, surgeons, and implant manufacturers should have guidelines in place that clearly define the role of reps in the OR, such that reps can add value, while avoiding legal liability. Cost pressures on hospitals from the pandemic and pressures from lawsuits targeting reps may lead to a new supply chain model, where the rep either has a diminished role, a more virtual role, or is no longer an essential component in every implant case. In the current healthcare environment, surgeon reliance on sales reps should be limited to routine steps, such as checking implant inventory, having back-up implants, opening implant boxes, and related duties. Actions such as templating radiographs, selecting implant sizes, citing instructions-for-use information to the surgeon, and advice or input during surgery likely go beyond the scope of rep duties, regardless of an individual rep’s competence in these areas. To avoid invasion of privacy claims, the patient should be informed of the presence and purpose of the rep in the OR, with written, informed consent. The surgeon should always have complete control of the operation, even if input from the sales rep was sought. At the end of the day, as the legal cases described in this column show, medical decisions are the responsibility of the surgeon, not the sales rep.