Manufacturers of medical devices may facilitate their use through industry representatives who can play an important role in patient safety and quality of care by providing information about the proper use of the device or equipment as well as technical assistance to physicians.
Plaintiff alleged facts, in good faith, that raise serious questions regarding the propriety of sales representatives in the operating room. The gravity of Plaintiff’s allegation that a sales representative performed, or participated in, [plaintiff’s] tumor ablation procedure is not lost on this court.
a licensed physician . . .has the knowledge of his patient’s medical history and background, and, therefore, he is in a better position, utilizing his medical judgment, to determine a patient’s needs and what medical care should be provided. It would be unreasonable, and potentially harmful, to require a clinical specialist . . . to delay or prevent a medical procedure simply because she believes the setting is not appropriate or the doctor is unqualified. To hold otherwise would place a medical device manufacturer . . . in the middle of the doctor-patient relationship.
The undisputed facts show that [the sales rep] did not participate in the decision-making during [the] procedure. [His] role was limited to carrying “back up” products in their sterile packages to have available for the surgeon’s use, if necessary, and to observe preparation of the products. [He] did not “scrub in” for the procedure . . . and did not enter the sterile field. . . . [The surgeon] testified that the decisions made while he performed surgery were his own decisions.
The sole purpose of [the sales rep] being in the operating room was to provide [the surgeon] with information about the fixator, which information [the surgeon] then used to make his medical judgments. That is, [the surgeon] remained in control of the surgery vis-à-vis [the sales rep] and all other non-physicians in the operating room. Because [the surgeon] remained in control of the surgery, anything [the sales rep] might have done during that surgery, including any advice he allegedly gave or should have given to [the surgeon], was done as a crew member, so to speak, of the surgical ship.
Although the written instructions [provided recommendations for use], [the sales rep] did not make these recommendations to the doctor. Despite the fact that he was professionally obligated to inform [the surgeon] about the use of the product and personally observed the size of [plaintiff’s] cranial defect, [the sales rep] did not uphold his duty of ensuring that the product was used properly.
What is at issue …is whether, notwithstanding the FDA approved written pacemaker replacement warnings, [the sales rep], by his oral communications to [the physician] that turning down the pacemaker was an option, accompanied by his physical adjustment of the pacemaker . . ., actually contradicted the manual, thereby vitiating and nullifying the manual’s warnings.
[Defendant] provided a technician to assist in the surgery, and, by doing so, assumed a duty to [plaintiff] to ensure that the technician . . . was knowledgeable about the equipment and competent to provide technical assistance to physicians using the equipment. . . . The fact that [the surgeon] had the responsibility to exercise his clinical judgment to determine appropriate settings and was required by the standard of care to confirm that the settings he selected had been entered does not preclude negligence on the part of [the technician] from being a substantial contributing cause of [plaintiff’s] injuries.