Company Representatives and Modern Medical Technology

Heightened Duty

Most typically, however, plaintiffs attempt to impose on the sales representative, and therefore on the manufacturer, a heightened duty based on the representative's presence in the operating room. Device manufacturers may face negligence claims stemming from either action or inaction on the part of their representatives. These cases are more common and closer to traditional failure-to-warn cases, yet the presence of representatives during surgery has led some courts to find a duty that seemingly trumps the learned intermediary doctrine, the largely accepted rule that pharmaceutical and medical device manufacturers have a duty to warn physicians, not patients. The analyses in these cases are largely fact-sensitive, suggesting there is a fine line between a representative's being a valuable asset to the surgical team and a potential liability for the manufacturer. While there are few reported decisions on this topic, the takeaway, despite some favorable outcomes, is that there is real risk of liability if the representative gets too involved in the actual treatment of the patient, use of equipment during surgery, or provision of advice or instruction to the physician.

In Kennedy v. Medtronic, 851 N.E.2d 778 (Ill. App.Ct. 2006), a pacemaker manufacturer faced product liability claims after its clinical specialist attended the implantation of a pacemaker in an outpatient facility “to provide technical support and ensure that the [pacemaker's] lead parameters were correctly calibrated and the lead was functioning properly.” Id. at 787. The plaintiff alleged that the manufacturer owed a duty of care to the plaintiff to: 1) “refrain from providing a pacemaker” to the surgeon when she knew the procedure would not be performed in a hospital; 2) warn of the dangers of the procedure under those conditions; and 3) “assist with the insertion in a reasonable manner once it voluntarily undertook to participate.” Id. at 782. Affirming the trial court's grant of defendant's summary judgment motion and relying on the learned intermediary doctrine, the appellate court held that requiring a company representative to police a physician's conduct or second-guess a physician's medical judgment would inappropriately place the device manufacturer in the middle of the doctor-patient relationship. Id. at 786.

In Wolicki-Gables v. Arrow International, Inc., 641 F.Supp.2d 1270 (M.D. Fla. 2009), aff'd on other grounds, 634 F.3d 1296 (11th Cir. 2011), the court was also unwilling to find that a sales representative's presence in the operating room during the implantation of a pain pump created a duty for the medical device manufacturer. In that case, the representative did not “scrub in” or enter the sterile field, and merely carried “back-up” products for the surgeon to use if necessary. Id. Significantly, the court went on to say that even if the representative did interact with the surgeon during surgery, he did not have “a duty to affirmatively tell” the surgeon how to use the device. Id.

Similarly, in Harrington v. Biomet, 2008 WL 2329132 (W.D. Okla. June 3, 2008), the court held that a sales representative who was present in the operating room during a hip replacement surgery had no duty to warn the patient or advise the surgeon about which product to use. The court granted defendant's motion for summary judgment because the plaintiff could not show that the representative had a duty to advise the surgeon or “voluntarily undertook to do so.” Id. at *7. The second duty for which the court found no breach raises a potential issue for manufacturers and their representatives. While there was no affirmative duty to advise the surgeon, if the representative had done so and provided incorrect information, would the outcome have been different?

Heightened Duty-to-Warn

At least one potential answer may be found in Zappola v. Leibinger, 2006 WL 1174448 (Ohio App. May 4, 2006), in which a jury found the plaintiff's surgeon, the medical device manufacturer, and the manufacturer's representative liable for negligence when the product the surgeon used to close the plaintiff's skull following brain surgery failed. The surgeon used the product at the recommendation of the representative, who was present at the surgery. Id. at *3. The court disagreed with the manufacturer's argument that the product's labeling satisfied its duty-to-warn under the learned intermediary doctrine, finding that even though the written instructions provided recommendations for use, the representative “did not make these recommendations to the doctor.” Id. at *2-3, 6. In fact, the court stated that even though the representative was “professionally obligated” to inform the surgeon about the product and had “personally observed” the plaintiff's cranial defect, he “did not uphold his duty of ensuring that the product was used properly.” Id. The fact that the representative observed the plaintiff's condition appears to have been enough for the court to impose on the representative and manufacturer a heightened duty-to-warn, despite the fact that the learned intermediary in this case was a neurosurgeon who had past experience with the product. See also Chamian v. Sharplan Laser, Inc., 2004 WL 2341569 (Mass. Super. Sep. 24, 2004) (holding that a defendant distributor could be negligent for providing an incompetent technician to assist in a laser surgery procedure when the incorrect settings recommended and applied by the technician, although approved by the surgeon, resulted in burns to the plaintiff's face).

Although not a case involving the operating room, in Hurley v. Heart Physicians, P.C., 898 A.2d 777 (Conn. 2006), a cardiologist asked a pacemaker company representative to attend an examination of his young patient to test the pacemaker's battery and make adjustments as needed. Id. at 780. When the patient's mother allegedly refused to replace the pacemaker as recommended, the cardiologist and the representative discussed a downward adjustment to the rate of the pacemaker to prolong the battery life. Id. at 780-81. After the adjustment, the plaintiff suffered a cardiac event, resulting in permanent brain damage. Id. The Connecticut Supreme Court reversed the trial court's grant of the defendant's motion for summary judgment, stating, “What is at issue ' is whether, notwithstanding the FDA approved written pacemaker replacement warnings, [the representative], by his oral communications ' 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.” Id. at 786-87. Finding a question of fact, the case was remanded for trial on this issue. Ultimately, a jury found in favor of the defendant and the verdict was upheld on appeal. See Hurley v. Heart Physicians, P.C., 3 A.3d 892, 899-900 (Conn. 2010). However, the Connecticut Supreme Court's decision suggests that a company representative can negate a manufacturer's otherwise adequate warnings through his advice about and physical involvement with a device, even when the physician remains the ultimate medical decision maker.

In the Courts

Clearly, at least a few courts have been swayed by the presence of sales representatives in operating and procedure rooms to forego the learned intermediary doctrine. When sales representatives are limited to certain clearly defined activities, courts appear to be less willing to impose a duty on the representatives and their employers. If representatives do overstep their bounds, however, and exhibit behavior that could be construed as exercising medical judgment or interfering with the doctor-patient relationship, they can expose themselves and their employers to additional liability. Also, if a court construes a representative's actions as nullifying the FDA-approved warnings that accompany the product, it will be more likely to strip the manufacturer of the protection of the learned intermediary doctrine. Representatives and their employers are best protected when it is clear that the physician is the “captain of the ship.” See O'Connell v. Biomet, Inc., 250 P.3d 1278, 1283-84 (Colo. App. 2010) (holding that provided a surgeon maintains control of the surgery and exercises her own medical judgment, she is the “captain of the ship,” regardless of sales representative involvement).

Managing Risks

Sales representatives who participate actively in the operating room may run the risk of exposing themselves and their employer to liability in the event something goes wrong. Nonetheless, there are steps that can be taken to mitigate potential exposure and maximize patient outcomes.

Healthcare industry guidance has been developed to maintain patient safety and privacy when company representatives are in the operating room. Recognizing both that the presence of representatives may increase patient safety and quality of care, but also the potential risks of representative involvement, the American College of Surgeons issued guidance in 2005 on the role of healthcare industry representatives in the operating room. The statement recommends that operating rooms establish written policies to ensure that representatives are properly trained and monitored. See American College of Surgeons, ST-33 Statement on Health Care Industry Representatives in the Operating Room, available at www.facs.org/fellows_info/statements/st-33.html. The statement also notes that representatives should be monitored at all times and may remotely calibrate and adjust medical devices to the surgeons' and manufacturers' specifications, but should not “engage in the practice of surgery, nursing, or medical decision making,” or “scrub in or be involved in direct patient contact.” Id. See also Association of periOperative Registered Nurses, AORN Position Statement, “The Role of the Healthcare Industry Representative in the PeriOperative/Invasive Procedure Setting, available at www.aorn.org/WorkArea/DownloadAsset.aspx?id=21922.

Device manufacturers may avoid invasion of privacy and other potential claims by ensuring that patients have given informed consent to the presence of the representative during their medical procedure. Manufacturers likely will increasingly work to develop policies and training programs that mirror industry and facility guidance, and that ensure their representatives avoid conduct that has proven problematic in the past or that creates the appearance that they are exercising medical judgment or interfering with the doctor-patient relationship.

In those cases where a doctor independently misuses a manufacturer's product, based on her own medical judgment, liability should not extend to the manufacturer, whose representative has no affirmative duty to substitute his own judgment for the doctor's and prevent the misuse. When advising physicians, representatives also should be protected if they limit their advice to information contained within the FDA-approved labeling. Failure to do so can expose manufacturers not only to product liability and tort claims, but to allegations against the manufacturer stemming from alleged off-label promotion. Such allegations have surfaced recently in, among others, U.S. ex rel Bennett v. Boston Scientific, 2011 WL 1231577 (S.D. Tex. Mar. 31, 2011), a qui tam action by a former sales representative under the False Claims Act, who alleges that the company trained its sales representatives to accompany doctors into the operating room and teach them how to use a medical device for an off-label use.

Conclusion

While many device manufacturers possess knowledge that can be useful to doctors and enhance patient safety, companies and their employees must ensure that they do not become overly involved in patient care or otherwise overstep the appropriate bounds. The development of clear policies and rigorous training programs for representatives reduces the potential exposure for medical device companies who send representatives into the operating room.

Michelle Hart Yeary is Counsel and Alicia M. Farley is an associate in the Product Liability and Mass Torts Group at Dechert LLP. Portions of this article originally appeared in a “Drug and Device Law” blog post on Sept. 23, 2011.

When we think of sales representatives in the healthcare setting, we typically picture pharmaceutical representatives visiting doctors' offices to distribute samples and promotional materials. In recent years, however, as medical device technology has rapidly advanced, the presence of medical device company representatives in operating and procedure rooms has become increasingly common. Whether representatives attend surgeries to observe uses of the device, to assist the medical staff by making the appropriate supplies available, or to calibrate technical products, their presence can be a benefit to surgeons, companies, and patients alike. However, while company representatives can provide technical support for complex devices and keep surgical staff informed about new technology, their presence in operating and procedure rooms is not without controversy. When things go wrong, patients may use the presence of company representatives to advance theories of liability against device manufacturers that they would otherwise not face.

Theories of Liability

In a small number of cases, a representative's mere presence in an operating or exam room has been enough to expose a manufacturer to potential liability for invasion of privacy. See, e.g., Sanchez-Scott v. Alza Pharmaceuticals , 103 Cal. Rptr.2d 410 (Cal. Ct. App. 2001) (holding that a manufacturer could be held liable for invasion of privacy when a sales representative observed plaintiff's breast examination and was not identified to plaintiff as an employee of defendant). Plaintiffs have also occasionally accused sales representatives of the unauthorized practice of medicine. In one of the oldest and most extreme unauthorized practice of medicine cases, People v. Smithtown General Hospital , 93 Misc.2d 736 (Suffolk County NY 1978), criminal charges were brought against the physicians and hospital where a hip prosthesis company representative participated in a surgery. The court noted that where the representative not only scrubbed in, but, with the surgeon's consent, removed the hip prosthesis and completed the rest of the surgery, a jury could reasonably conclude that he had engaged in the unauthorized practice of medicine. Id. at 739-740; but see Disbrow v. Smith & Nephew Richards Inc., 1996 WL 593780 (Tx. App. Oct. 17, 1996) (granting defendants' motion for summary judgment where a device manufacturer's representative was present during a hip replacement surgery but merely assisted the nurse in locating a tool). Although it was dismissed on statute of limitations grounds, Wilkerson v. Christian, 2008 WL 483445 (M.D.N.C. Feb. 19, 2008), suggests that unauthorized practice of medicine allegations against company representatives persist. See Id. at *11 (“Plaintiff alleged facts ' 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, [decedent's] tumor ablation procedure is not lost on this court.”).

Heightened Duty

Most typically, however, plaintiffs attempt to impose on the sales representative, and therefore on the manufacturer, a heightened duty based on the representative's presence in the operating room. Device manufacturers may face negligence claims stemming from either action or inaction on the part of their representatives. These cases are more common and closer to traditional failure-to-warn cases, yet the presence of representatives during surgery has led some courts to find a duty that seemingly trumps the learned intermediary doctrine, the largely accepted rule that pharmaceutical and medical device manufacturers have a duty to warn physicians, not patients. The analyses in these cases are largely fact-sensitive, suggesting there is a fine line between a representative's being a valuable asset to the surgical team and a potential liability for the manufacturer. While there are few reported decisions on this topic, the takeaway, despite some favorable outcomes, is that there is real risk of liability if the representative gets too involved in the actual treatment of the patient, use of equipment during surgery, or provision of advice or instruction to the physician.

In Kennedy v. Medtronic , 851 N.E.2d 778 (Ill. App.Ct. 2006), a pacemaker manufacturer faced product liability claims after its clinical specialist attended the implantation of a pacemaker in an outpatient facility “to provide technical support and ensure that the [pacemaker's] lead parameters were correctly calibrated and the lead was functioning properly.” Id. at 787. The plaintiff alleged that the manufacturer owed a duty of care to the plaintiff to: 1) “refrain from providing a pacemaker” to the surgeon when she knew the procedure would not be performed in a hospital; 2) warn of the dangers of the procedure under those conditions; and 3) “assist with the insertion in a reasonable manner once it voluntarily undertook to participate.” Id. at 782. Affirming the trial court's grant of defendant's summary judgment motion and relying on the learned intermediary doctrine, the appellate court held that requiring a company representative to police a physician's conduct or second-guess a physician's medical judgment would inappropriately place the device manufacturer in the middle of the doctor-patient relationship. Id. at 786.

In Wolicki-Gables v. Arrow International, Inc. , 641 F.Supp.2d 1270 (M.D. Fla. 2009), aff'd on other grounds, 634 F.3d 1296 (11th Cir. 2011), the court was also unwilling to find that a sales representative's presence in the operating room during the implantation of a pain pump created a duty for the medical device manufacturer. In that case, the representative did not “scrub in” or enter the sterile field, and merely carried “back-up” products for the surgeon to use if necessary. Id. Significantly, the court went on to say that even if the representative did interact with the surgeon during surgery, he did not have “a duty to affirmatively tell” the surgeon how to use the device. Id.

Similarly, in Harrington v. Biomet, 2008 WL 2329132 (W.D. Okla. June 3, 2008), the court held that a sales representative who was present in the operating room during a hip replacement surgery had no duty to warn the patient or advise the surgeon about which product to use. The court granted defendant's motion for summary judgment because the plaintiff could not show that the representative had a duty to advise the surgeon or “voluntarily undertook to do so.” Id. at *7. The second duty for which the court found no breach raises a potential issue for manufacturers and their representatives. While there was no affirmative duty to advise the surgeon, if the representative had done so and provided incorrect information, would the outcome have been different?

Heightened Duty-to-Warn

At least one potential answer may be found in Zappola v. Leibinger, 2006 WL 1174448 (Ohio App. May 4, 2006), in which a jury found the plaintiff's surgeon, the medical device manufacturer, and the manufacturer's representative liable for negligence when the product the surgeon used to close the plaintiff's skull following brain surgery failed. The surgeon used the product at the recommendation of the representative, who was present at the surgery. Id. at *3. The court disagreed with the manufacturer's argument that the product's labeling satisfied its duty-to-warn under the learned intermediary doctrine, finding that even though the written instructions provided recommendations for use, the representative “did not make these recommendations to the doctor.” Id. at *2-3, 6. In fact, the court stated that even though the representative was “professionally obligated” to inform the surgeon about the product and had “personally observed” the plaintiff's cranial defect, he “did not uphold his duty of ensuring that the product was used properly.” Id. The fact that the representative observed the plaintiff's condition appears to have been enough for the court to impose on the representative and manufacturer a heightened duty-to-warn, despite the fact that the learned intermediary in this case was a neurosurgeon who had past experience with the product. See also Chamian v. Sharplan Laser, Inc., 2004 WL 2341569 (Mass. Super. Sep. 24, 2004) (holding that a defendant distributor could be negligent for providing an incompetent technician to assist in a laser surgery procedure when the incorrect settings recommended and applied by the technician, although approved by the surgeon, resulted in burns to the plaintiff's face).

Although not a case involving the operating room, in Hurley v. Heart Physicians, P.C. , 898 A.2d 777 (Conn. 2006), a cardiologist asked a pacemaker company representative to attend an examination of his young patient to test the pacemaker's battery and make adjustments as needed. Id. at 780. When the patient's mother allegedly refused to replace the pacemaker as recommended, the cardiologist and the representative discussed a downward adjustment to the rate of the pacemaker to prolong the battery life. Id. at 780-81. After the adjustment, the plaintiff suffered a cardiac event, resulting in permanent brain damage. Id. The Connecticut Supreme Court reversed the trial court's grant of the defendant's motion for summary judgment, stating, “What is at issue ' is whether, notwithstanding the FDA approved written pacemaker replacement warnings, [the representative], by his oral communications ' 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.” Id. at 786-87. Finding a question of fact, the case was remanded for trial on this issue. Ultimately, a jury found in favor of the defendant and the verdict was upheld on appeal. See Hurley v. Heart Physicians, P.C. , 3 A.3d 892, 899-900 (Conn. 2010). However, the Connecticut Supreme Court's decision suggests that a company representative can negate a manufacturer's otherwise adequate warnings through his advice about and physical involvement with a device, even when the physician remains the ultimate medical decision maker.

In the Courts

Clearly, at least a few courts have been swayed by the presence of sales representatives in operating and procedure rooms to forego the learned intermediary doctrine. When sales representatives are limited to certain clearly defined activities, courts appear to be less willing to impose a duty on the representatives and their employers. If representatives do overstep their bounds, however, and exhibit behavior that could be construed as exercising medical judgment or interfering with the doctor-patient relationship, they can expose themselves and their employers to additional liability. Also, if a court construes a representative's actions as nullifying the FDA-approved warnings that accompany the product, it will be more likely to strip the manufacturer of the protection of the learned intermediary doctrine. Representatives and their employers are best protected when it is clear that the physician is the “captain of the ship.” See O'Connell v. Biomet, Inc. , 250 P.3d 1278, 1283-84 (Colo. App. 2010) (holding that provided a surgeon maintains control of the surgery and exercises her own medical judgment, she is the “captain of the ship,” regardless of sales representative involvement).

Managing Risks

Sales representatives who participate actively in the operating room may run the risk of exposing themselves and their employer to liability in the event something goes wrong. Nonetheless, there are steps that can be taken to mitigate potential exposure and maximize patient outcomes.

Healthcare industry guidance has been developed to maintain patient safety and privacy when company representatives are in the operating room. Recognizing both that the presence of representatives may increase patient safety and quality of care, but also the potential risks of representative involvement, the American College of Surgeons issued guidance in 2005 on the role of healthcare industry representatives in the operating room. The statement recommends that operating rooms establish written policies to ensure that representatives are properly trained and monitored. See American College of Surgeons, ST-33 Statement on Health Care Industry Representatives in the Operating Room, available at www.facs.org/fellows_info/statements/st-33.html. The statement also notes that representatives should be monitored at all times and may remotely calibrate and adjust medical devices to the surgeons' and manufacturers' specifications, but should not “engage in the practice of surgery, nursing, or medical decision making,” or “scrub in or be involved in direct patient contact.” Id. See also Association of periOperative Registered Nurses, AORN Position Statement, “The Role of the Healthcare Industry Representative in the PeriOperative/Invasive Procedure Setting, available at www.aorn.org/WorkArea/DownloadAsset.aspx?id=21922.

Device manufacturers may avoid invasion of privacy and other potential claims by ensuring that patients have given informed consent to the presence of the representative during their medical procedure. Manufacturers likely will increasingly work to develop policies and training programs that mirror industry and facility guidance, and that ensure their representatives avoid conduct that has proven problematic in the past or that creates the appearance that they are exercising medical judgment or interfering with the doctor-patient relationship.

In those cases where a doctor independently misuses a manufacturer's product, based on her own medical judgment, liability should not extend to the manufacturer, whose representative has no affirmative duty to substitute his own judgment for the doctor's and prevent the misuse. When advising physicians, representatives also should be protected if they limit their advice to information contained within the FDA-approved labeling. Failure to do so can expose manufacturers not only to product liability and tort claims, but to allegations against the manufacturer stemming from alleged off-label promotion. Such allegations have surfaced recently in, among others, U.S. ex rel Bennett v. Boston Scientific, 2011 WL 1231577 (S.D. Tex. Mar. 31, 2011), a qui tam action by a former sales representative under the False Claims Act, who alleges that the company trained its sales representatives to accompany doctors into the operating room and teach them how to use a medical device for an off-label use.

Conclusion

While many device manufacturers possess knowledge that can be useful to doctors and enhance patient safety, companies and their employees must ensure that they do not become overly involved in patient care or otherwise overstep the appropriate bounds. The development of clear policies and rigorous training programs for representatives reduces the potential exposure for medical device companies who send representatives into the operating room.

Michelle Hart Yeary is Counsel and Alicia M. Farley is an associate in the Product Liability and Mass Torts Group at Dechert LLP. Portions of this article originally appeared in a “Drug and Device Law” blog post on Sept. 23, 2011.