Protecting Against Unique Claims Regarding Medical Device Sales Reps

Recent Decisions Holding Sales Reps Did Not Have a Duty to Patients

Kennedy v. Medtronic, Inc.

Courts have found that sales reps cannot be held liable pursuant to the learned intermediary doctrine because they do not have a duty to warn a patient. This is especially true where the representative performs a limited role during the patient-physician visit or where the representative's communications and conduct are in accord with the device manual's FDA-approved warnings. See, e.g., Kennedy v. Medtronic, Inc., 366 Ill. App. 3d 298, 307-309, 851 N.E.2d 778, 785-87 (2006). For example, in Kennedy, the Illinois Court of Appeals held that, pursuant to the learned intermediary doctrine, a medical device sales representative does not have a duty to warn the patient of the risks involved with the implantation of the device. Id. at 306-07, 851 N.E.2d at 785-86.

In Kennedy, the plaintiff's father died following the placement of a pacemaker lead into his left rather than his right ventricle. Id. at 300, 851 N.E.2d at 780. A representative of the lead manufacturer was present during the procedure to ensure that after the lead's implantation, it was sensing the patient's heart rhythm appropriately. Id. at 301, 851 N.E.2d at 781. The plaintiff contended that once the manufacturer's representative discovered that the procedure was taking place in a non-hospital setting without proper personnel and equipment, the manufacturer had a duty to warn the patient of the dangers inherent in proceeding with the surgery under those conditions Id. at 306, 851 N.E.2d at 785. The plaintiff further alleged that the manufacturer had a duty to refrain from providing the pacemaker to the doctor and from participating in the implantation of the device. Id. The plaintiff also claimed that the manufacturer voluntarily assumed a duty to the patient because its representative reassured the plaintiff of the doctor's qualification in performing the pacemaker implant procedure. Id. at 308, 851 N.E.2d at 786.

The court rejected the plaintiff's theories, finding that the representative's limited role of providing technical support and ensuring that the lead was functioning properly did not result in a duty of the representative to the patient. Id. at 308, 851 N.E.2d at 787. Likewise, the court held that the representative's assurances to the plaintiff prior to the procedure did not constitute representations about the conditions under which the surgery was being performed at the outpatient facility and that the patient would have proceeded with the surgery without the representative's alleged statements. Id. at 308-09, 851 N.E.2d at 787. The court explained that in accordance with the learned intermediary doctrine, the physician was in a better position to determine the patient's needs because he
had knowledge of the patient's medical history, and he could utilize his medical training and judgment. Id. at 307, 851 N.E.2d at 786.

The court further reasoned that the burden on the manufacturer of monitoring the conditions under which a physician performs surgery would be substantial. Id. In addition, the court held that the consequences of placing this burden on the manufacturer are potentially harmful because it would place the manufacturer in the middle of the physician-patient relationship and may result in damage to a patient who is denied a needed medical device because a manufacturer decided that the conditions were not optimal. Id. at 307, 851 N.E.2d at 785-86.

Harrington v. Biomet, Inc.

In accord with the Kennedy decision, the court in Harrington v. Biomet, Inc. held that a medical device sales rep who was present in the operating room when the device was being implanted into the plaintiff does not owe a duty to warn the plaintiff or to advise the surgeon as to what size and type of components to use in the plaintiff's particular case. Harrington v. Biomet, Inc., No. CIV-07-25-R, 2008 WL 2329132, at *7 (W.D. Okla. June 3, 2008). In Harrington, the plaintiff underwent hip replacement surgery and subsequently suffered 11 dislocations of the prosthetic hip. Id. at *2. In addition to other claims, the plaintiff alleged that the prosthetic hip manufacturer was liable for the dislocations because its representative failed to warn the physician or the plaintiff of the alleged hidden dangers of prosthetic hip implantation and because its representative, who was present during the implant procedure, failed to advise the surgeon as to what size and type of components to use in the plaintiff's particular case. Id. at *6-7. The court granted the defendant's motion for summary judgment, holding that the warnings the manufacturer provided to the surgeon regarding the risk of dislocation, which were FDA-approved and contained in the device's manual, were adequate as a matter of law. Id. at *6. Pursuant to the learned intermediary doctrine, as the surgeon was provided adequate warnings, the manufacturer and its representative could not be liable for failing to warn the plaintiff. Id. The court also found that the plaintiff failed to prove that the sales representative had a duty to advise the surgeon regarding the components of the prosthetic hip or voluntarily undertook any such duty. Id. at *7.

Recent Decisions Holding That Sales Reps May Have a Duty to Patients

Hurley v. Heart Physicians, P.C.

Other courts have held that a medical device manufacturer may be precluded from using the learned intermediary doctrine as a defense for a failure-to-warn claim if its representative's communications and conduct are inconsistent with the warning language contained in the medical device's instruction manual. See, e.g., Hurley v. Heart Physicians, P.C., 278 Conn. 305, 321, 898 A.2d 777, 787 (2006). In Hurley, for example, when the plaintiff's pacemaker's elective replacement indicator signaled, her physician asked a representative of the pacemaker's manufacturer how to turn off the pacemaker in order to assess the patient's underlying heart condition. Id. at 310-11, 898 A.2d at 780-81. The representative responded to the physician that turning the pacemaker's rate down was an option and, at the physician's direction, the representative turned the rate of the pacemaker down. Id. Subsequently, the plaintiff suffered a cardiac event, causing permanent brain damage, which the plaintiff alleged was caused by the downward adjustment of the pacemaker rate. Id. at 307, 898 A.2d at 778.

The Connecticut Supreme Court held that the trial court erred in granting the defendant's motion for summary judgment based on the learned intermediary doctrine. Id. at 323-24, 898 A.2d 788. The court held that a material issue of fact existed regarding whether the representative's statements and conduct were in derogation of the warnings in the pacemaker's manual. Id. The court found that generally the learned intermediary doctrine applies as a defense to failure-to-warn claims against manufacturers where manufacturers provide adequate, FDA-approved warnings to the physician that are contained in the pacemaker's manual. See Id. at 316-17, 898 A.2d at 783-84. The court explained that the physician is in the best position to evaluate the patient's needs and assess the risks and benefits of a particular course of treatment. Id. The court held, however, that an exception to this defense arises when the manufacturer's representative engages in communication and conduct that contradicts the manual's instructions, thereby nullifying its warnings and creating a question of fact for the jury. Id. at 321-22, 898 A.2d at 786-87.

Wehner v. Linvatech Corp.

In Wehner v. Linvatech Corp., No. 06-CV-1709 JMR/FLN, 2008 WL 495525, at *4-5 (D. Minn. Feb. 20, 2008), while the sales representative was not individually named as a defendant, the court's analysis regarding the representative's effect on the manufacturer's duty to warn is instructive. The plaintiff in Wehner underwent shoulder surgery to repair several tears and Superior Labrum from Anterior to Posterior (SLAP lesions). Id. at *1. During the surgery, the surgeon implanted tacks into the plaintiff's shoulder. Id. While the package insert for the tacks warns not to use them to repair a SLAP lesion, the product handout did not contain those warnings. Id. at *4. Subsequently, the tacks failed to dissolve, resulting in an alleged deteriorated shoulder that would require multiple future surgeries. Id. at *1. The plaintiff sued the tack manufacturer for failure-to-warn. Id. The plaintiff contended that the sales representative did not know that the tacks should not be used for SLAP lesions and thus improperly promoted the use of the tacks for SLAP lesions to physicians. Id. at *4. The plaintiff further argued that the sales representative only provided the surgeon with the product handout and not the package insert, such that the surgeon never read the warnings against tack usage with SLAP lesions. Id. In addition, the plaintiff in Wehner alleged that the manufacturer's warnings were inadequate. Id. at *5.

The court denied the manufacturer's motion for summary judgment, holding that a question of fact existed as to the manufacturer's duty to warn and whether it was breached based on the actions of the sales representative. Id. at *4. The court found that whether the sales representative presented the surgeon with the literature containing the proper warnings was determinative of the availability of the learned intermediary defense to the manufacturer. See Id. at *4. If the warnings never reached the learned intermediary, then the manufacturer's duty to warn was not satisfied. See Id. The manufacturer also argued that the plaintiff's claim of inadequate warning should be dismissed because a claim of inadequate warning presupposes that the surgeon has read the warning, and the surgeon here admitted that he had not read the package insert containing the relevant warnings, such that the plaintiff could not establish causation. Id. at *5. The court rejected the manufacturer's argument, finding that the manufacturer's usual means of communication with physicians is through its sales representatives, and, in this case, the manufacturer's sales representative himself was unfamiliar with the warnings on the package insert and had actually promoted use of the product that was in derivation of the warnings. Id. Thus, because the warnings provided by the sales representative were inadequate, the court held that summary judgment in favor of the manufacturer was not warranted. Id.

A Post-Riegel Decision

There have been few trial court decisions applying the U.S. Supreme Court recent decision in Riegel, holding generally that product liability claims in cases involving a Class III medical device are preempted by the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act (DA , 21 U.S.C. 360c, et seq.). Recently, however, the United States District Court for the Western District of Virginia, Danville Division, analyzed the application of the Riegel decision to claims involving medical device sales representatives. Adkins v. Cytyc Corp., No. 4:07CV00053, 2008 WL 2680474, at *2-3 (W.D. Va. July 3, 2008). In Adkins, the plaintiff underwent an endometrial ablation procedure with a NovaSure medical device. Id. at *1. During the procedure, the device manufacturer's representative was present in the operating room and allegedly advised and directed the physician regarding how to measure the size of the plaintiff's uterus and how to test the device. Id. at *2. The plaintiff subsequently suffered a thermal burn to her sigmoid colon from the device. Id. at *1. In addition to asserting traditional product liability claims, the plaintiff asserted that the manufacturer's representative failed to take the necessary steps to protect the plaintiff from the device. Id. at *2.

The court granted the defendant device manufacturer's motion to dismiss the plaintiff's negligence claims related to design, manufacturing, and labeling of the device on the grounds that such claims were preempted under the Riegel decision. Id. at *3. The court, however, held that the plaintiff's cause of action regarding the sales representative was not governed by the holding in Riegel because “[s]uch a claim does not challenge the design, manufacture, and labeling of the [device] so as to implicate Riegel preemption, but rather challenges negligence by a corporate agent acting as a de facto physician assistant during a surgical procedure.” Id. at *3. The court dismissed these claims with leave to amend because the plaintiff failed to allege in the complaint what the manufacturer's representative did or failed to do as part of his alleged duty. Id. The court also held that the plaintiff had not raised more than a mere suspicion of a cognizable right of action, as the plaintiff offered no link between the alleged steps the manufacturer's representative should have taken and the cause of the plaintiff's injuries. Id.

Conclusion

The effect of the U.S. Supreme Court's opinion in Riegel on unique claims involving medical device sales representatives is unclear. Although this is still a developing area of the law, medical device manufacturers can use these recent decisions to develop a training program for their sales force. Based on these opinions, medical device manufacturers should, at a minimum, train their sales representatives on the following points:

• The sales representative's role is a limited one ' to provide technical support regarding the device or instrumentation only; The sales representative should not become a de facto physician's assistant, Adkins, 2008 WL 2680474 at *3;
• The sales representative should not offer advice or make suggestions regarding patient medical or clinical care decisions. All should be left to the independent judgment of the treating physician;
• The sales representative should not offer any assurances or advice to the patient directly regarding the physician, the medical device or the medical procedure at issue;
• The sales representative should only make statements to the physician regarding the device that are consistent with the warnings in the package insert or physician manual;
• The sales representative should not promote uses of the device outside of those approved by the FDA, as specified in the package insert or physician manual; and
• The sales representative should make sure that the physician has all product literature containing warnings regarding the device.

A sales force that is well-versed in these themes, as well as training documents that reflect these themes, will aid in the defense of creative allegations involving medical device sales representatives.

Lori G. Cohen, a member of this newsletter's Board of Editors, is a shareholder in Greenberg Traurig, LLP's Atlanta office and is the Chair of Greenberg Traurig Pharmaceutical and Medical Device Litigation Group. She has been recognized by the National Law Journal, a sister publication of this newsletter, as one of the 50 Most Influential Women Lawyers in America.
Christiana C. Jacxsens is an associate in the same group. She concentrates her practice on complex medical and product liability litigation, with a focus on pharmaceutical and medical device litigation.

In recent years, pharmaceutical and medical device manufacturers have faced an increased number of creative product liability claims arising from alleged actions of their sales representatives. Medical device manufacturers may face a challenge in preventing these claims because of the unique role of these representatives. Medical device sales representatives, as compared with pharmaceutical sales representatives, may be present during patient-physician visits to provide technical support for the device or instrumentation. This distinct role makes medical device manufacturers susceptible to allegations that the sales representative somehow improperly inserted herself or himself into the patient-physician relationship or otherwise affected patient care. Unlike cases involving allegations regarding pharmaceutical sales representatives, there are few rulings in cases with claims involving medical device sales representatives. Further, it is unclear what the effect of the recent U.S. Supreme Court opinion in Riegel v. Medtronic , 128 S. Ct. 999 (2008), will be on these claims. Although this is a developing area of the law, recent court decisions can provide medical device manufacturers with some insight into pertinent training topics for its sales force, in order to protect against these types of claims.

The Learned Intermediary Doctrine

Courts' analyses of these claims regarding sales representatives can focus on the issue of whether the sales representative had a direct duty to the patient in light of the learned intermediary doctrine. Under the learned intermediary doctrine, it is the duty of the treating physician to discuss warnings and risks regarding the prescription medical device at issue with the patient. The basic premise behind this rule is that because certain medical devices can only be prescribed by a licensed physician, a manufacturer's duty to provide applicable warnings runs only to that physician, and not to the patient receiving the device. Although no consistent rule of law has emerged, recent decisions demonstrate that courts examine the specific actions or statements of medical device sales reps in determining whether the representative (or the manufacturer for vicarious liability of the sales representative) may be held liable to a patient. Generally, the more limited the role of the representative vis-'-vis the patient-physician relationship, the less likely the court will find that a cognizable claim exists against the sales representative.

Recent Decisions Holding Sales Reps Did Not Have a Duty to Patients

Kennedy v. Medtronic, Inc.

Courts have found that sales reps cannot be held liable pursuant to the learned intermediary doctrine because they do not have a duty to warn a patient. This is especially true where the representative performs a limited role during the patient-physician visit or where the representative's communications and conduct are in accord with the device manual's FDA-approved warnings. See, e.g., Kennedy v. Medtronic, Inc. , 366 Ill. App. 3d 298, 307-309, 851 N.E.2d 778, 785-87 (2006). For example, in Kennedy, the Illinois Court of Appeals held that, pursuant to the learned intermediary doctrine, a medical device sales representative does not have a duty to warn the patient of the risks involved with the implantation of the device. Id. at 306-07, 851 N.E.2d at 785-86.

In Kennedy, the plaintiff's father died following the placement of a pacemaker lead into his left rather than his right ventricle. Id. at 300, 851 N.E.2d at 780. A representative of the lead manufacturer was present during the procedure to ensure that after the lead's implantation, it was sensing the patient's heart rhythm appropriately. Id. at 301, 851 N.E.2d at 781. The plaintiff contended that once the manufacturer's representative discovered that the procedure was taking place in a non-hospital setting without proper personnel and equipment, the manufacturer had a duty to warn the patient of the dangers inherent in proceeding with the surgery under those conditions Id. at 306, 851 N.E.2d at 785. The plaintiff further alleged that the manufacturer had a duty to refrain from providing the pacemaker to the doctor and from participating in the implantation of the device. Id. The plaintiff also claimed that the manufacturer voluntarily assumed a duty to the patient because its representative reassured the plaintiff of the doctor's qualification in performing the pacemaker implant procedure. Id. at 308, 851 N.E.2d at 786.

The court rejected the plaintiff's theories, finding that the representative's limited role of providing technical support and ensuring that the lead was functioning properly did not result in a duty of the representative to the patient. Id. at 308, 851 N.E.2d at 787. Likewise, the court held that the representative's assurances to the plaintiff prior to the procedure did not constitute representations about the conditions under which the surgery was being performed at the outpatient facility and that the patient would have proceeded with the surgery without the representative's alleged statements. Id. at 308-09, 851 N.E.2d at 787. The court explained that in accordance with the learned intermediary doctrine, the physician was in a better position to determine the patient's needs because he
had knowledge of the patient's medical history, and he could utilize his medical training and judgment. Id. at 307, 851 N.E.2d at 786.

The court further reasoned that the burden on the manufacturer of monitoring the conditions under which a physician performs surgery would be substantial. Id. In addition, the court held that the consequences of placing this burden on the manufacturer are potentially harmful because it would place the manufacturer in the middle of the physician-patient relationship and may result in damage to a patient who is denied a needed medical device because a manufacturer decided that the conditions were not optimal. Id. at 307, 851 N.E.2d at 785-86.

Harrington v. Biomet, Inc.

In accord with the Kennedy decision, the court in Harrington v. Biomet, Inc. held that a medical device sales rep who was present in the operating room when the device was being implanted into the plaintiff does not owe a duty to warn the plaintiff or to advise the surgeon as to what size and type of components to use in the plaintiff's particular case. Harrington v. Biomet, Inc., No. CIV-07-25-R, 2008 WL 2329132, at *7 (W.D. Okla. June 3, 2008). In Harrington, the plaintiff underwent hip replacement surgery and subsequently suffered 11 dislocations of the prosthetic hip. Id. at *2. In addition to other claims, the plaintiff alleged that the prosthetic hip manufacturer was liable for the dislocations because its representative failed to warn the physician or the plaintiff of the alleged hidden dangers of prosthetic hip implantation and because its representative, who was present during the implant procedure, failed to advise the surgeon as to what size and type of components to use in the plaintiff's particular case. Id. at *6-7. The court granted the defendant's motion for summary judgment, holding that the warnings the manufacturer provided to the surgeon regarding the risk of dislocation, which were FDA-approved and contained in the device's manual, were adequate as a matter of law. Id. at *6. Pursuant to the learned intermediary doctrine, as the surgeon was provided adequate warnings, the manufacturer and its representative could not be liable for failing to warn the plaintiff. Id. The court also found that the plaintiff failed to prove that the sales representative had a duty to advise the surgeon regarding the components of the prosthetic hip or voluntarily undertook any such duty. Id. at *7.

Recent Decisions Holding That Sales Reps May Have a Duty to Patients

Hurley v. Heart Physicians, P.C.

Other courts have held that a medical device manufacturer may be precluded from using the learned intermediary doctrine as a defense for a failure-to-warn claim if its representative's communications and conduct are inconsistent with the warning language contained in the medical device's instruction manual. See, e.g., Hurley v. Heart Physicians, P.C. , 278 Conn. 305, 321, 898 A.2d 777, 787 (2006). In Hurley, for example, when the plaintiff's pacemaker's elective replacement indicator signaled, her physician asked a representative of the pacemaker's manufacturer how to turn off the pacemaker in order to assess the patient's underlying heart condition. Id. at 310-11, 898 A.2d at 780-81. The representative responded to the physician that turning the pacemaker's rate down was an option and, at the physician's direction, the representative turned the rate of the pacemaker down. Id. Subsequently, the plaintiff suffered a cardiac event, causing permanent brain damage, which the plaintiff alleged was caused by the downward adjustment of the pacemaker rate. Id. at 307, 898 A.2d at 778.

The Connecticut Supreme Court held that the trial court erred in granting the defendant's motion for summary judgment based on the learned intermediary doctrine. Id. at 323-24, 898 A.2d 788. The court held that a material issue of fact existed regarding whether the representative's statements and conduct were in derogation of the warnings in the pacemaker's manual. Id. The court found that generally the learned intermediary doctrine applies as a defense to failure-to-warn claims against manufacturers where manufacturers provide adequate, FDA-approved warnings to the physician that are contained in the pacemaker's manual. See Id. at 316-17, 898 A.2d at 783-84. The court explained that the physician is in the best position to evaluate the patient's needs and assess the risks and benefits of a particular course of treatment. Id. The court held, however, that an exception to this defense arises when the manufacturer's representative engages in communication and conduct that contradicts the manual's instructions, thereby nullifying its warnings and creating a question of fact for the jury. Id. at 321-22, 898 A.2d at 786-87.

Wehner v. Linvatech Corp.

In Wehner v. Linvatech Corp., No. 06-CV-1709 JMR/FLN, 2008 WL 495525, at *4-5 (D. Minn. Feb. 20, 2008), while the sales representative was not individually named as a defendant, the court's analysis regarding the representative's effect on the manufacturer's duty to warn is instructive. The plaintiff in Wehner underwent shoulder surgery to repair several tears and Superior Labrum from Anterior to Posterior (SLAP lesions). Id. at *1. During the surgery, the surgeon implanted tacks into the plaintiff's shoulder. Id. While the package insert for the tacks warns not to use them to repair a SLAP lesion, the product handout did not contain those warnings. Id. at *4. Subsequently, the tacks failed to dissolve, resulting in an alleged deteriorated shoulder that would require multiple future surgeries. Id. at *1. The plaintiff sued the tack manufacturer for failure-to-warn. Id. The plaintiff contended that the sales representative did not know that the tacks should not be used for SLAP lesions and thus improperly promoted the use of the tacks for SLAP lesions to physicians. Id. at *4. The plaintiff further argued that the sales representative only provided the surgeon with the product handout and not the package insert, such that the surgeon never read the warnings against tack usage with SLAP lesions. Id. In addition, the plaintiff in Wehner alleged that the manufacturer's warnings were inadequate. Id. at *5.

The court denied the manufacturer's motion for summary judgment, holding that a question of fact existed as to the manufacturer's duty to warn and whether it was breached based on the actions of the sales representative. Id. at *4. The court found that whether the sales representative presented the surgeon with the literature containing the proper warnings was determinative of the availability of the learned intermediary defense to the manufacturer. See Id. at *4. If the warnings never reached the learned intermediary, then the manufacturer's duty to warn was not satisfied. See Id. The manufacturer also argued that the plaintiff's claim of inadequate warning should be dismissed because a claim of inadequate warning presupposes that the surgeon has read the warning, and the surgeon here admitted that he had not read the package insert containing the relevant warnings, such that the plaintiff could not establish causation. Id. at *5. The court rejected the manufacturer's argument, finding that the manufacturer's usual means of communication with physicians is through its sales representatives, and, in this case, the manufacturer's sales representative himself was unfamiliar with the warnings on the package insert and had actually promoted use of the product that was in derivation of the warnings. Id. Thus, because the warnings provided by the sales representative were inadequate, the court held that summary judgment in favor of the manufacturer was not warranted. Id.

A Post-Riegel Decision

There have been few trial court decisions applying the U.S. Supreme Court recent decision in Riegel, holding generally that product liability claims in cases involving a Class III medical device are preempted by the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act (DA , 21 U.S.C. 360c, et seq.). Recently, however, the United States District Court for the Western District of Virginia, Danville Division, analyzed the application of the Riegel decision to claims involving medical device sales representatives. Adkins v. Cytyc Corp., No. 4:07CV00053, 2008 WL 2680474, at *2-3 (W.D. Va. July 3, 2008). In Adkins, the plaintiff underwent an endometrial ablation procedure with a NovaSure medical device. Id. at *1. During the procedure, the device manufacturer's representative was present in the operating room and allegedly advised and directed the physician regarding how to measure the size of the plaintiff's uterus and how to test the device. Id. at *2. The plaintiff subsequently suffered a thermal burn to her sigmoid colon from the device. Id. at *1. In addition to asserting traditional product liability claims, the plaintiff asserted that the manufacturer's representative failed to take the necessary steps to protect the plaintiff from the device. Id. at *2.

The court granted the defendant device manufacturer's motion to dismiss the plaintiff's negligence claims related to design, manufacturing, and labeling of the device on the grounds that such claims were preempted under the Riegel decision. Id. at *3. The court, however, held that the plaintiff's cause of action regarding the sales representative was not governed by the holding in Riegel because “[s]uch a claim does not challenge the design, manufacture, and labeling of the [device] so as to implicate Riegel preemption, but rather challenges negligence by a corporate agent acting as a de facto physician assistant during a surgical procedure.” Id. at *3. The court dismissed these claims with leave to amend because the plaintiff failed to allege in the complaint what the manufacturer's representative did or failed to do as part of his alleged duty. Id. The court also held that the plaintiff had not raised more than a mere suspicion of a cognizable right of action, as the plaintiff offered no link between the alleged steps the manufacturer's representative should have taken and the cause of the plaintiff's injuries. Id.

Conclusion

The effect of the U.S. Supreme Court's opinion in Riegel on unique claims involving medical device sales representatives is unclear. Although this is still a developing area of the law, medical device manufacturers can use these recent decisions to develop a training program for their sales force. Based on these opinions, medical device manufacturers should, at a minimum, train their sales representatives on the following points:

• The sales representative's role is a limited one ' to provide technical support regarding the device or instrumentation only; The sales representative should not become a de facto physician's assistant, Adkins, 2008 WL 2680474 at *3;
• The sales representative should not offer advice or make suggestions regarding patient medical or clinical care decisions. All should be left to the independent judgment of the treating physician;
• The sales representative should not offer any assurances or advice to the patient directly regarding the physician, the medical device or the medical procedure at issue;
• The sales representative should only make statements to the physician regarding the device that are consistent with the warnings in the package insert or physician manual;
• The sales representative should not promote uses of the device outside of those approved by the FDA, as specified in the package insert or physician manual; and
• The sales representative should make sure that the physician has all product literature containing warnings regarding the device.

A sales force that is well-versed in these themes, as well as training documents that reflect these themes, will aid in the defense of creative allegations involving medical device sales representatives.

Lori G. Cohen, a member of this newsletter's Board of Editors, is a shareholder in Greenberg Traurig, LLP's Atlanta office and is the Chair of Greenberg Traurig Pharmaceutical and Medical Device Litigation Group. She has been recognized by the National Law Journal, a sister publication of this newsletter, as one of the 50 Most Influential Women Lawyers in America.
Christiana C. Jacxsens is an associate in the same group. She concentrates her practice on complex medical and product liability litigation, with a focus on pharmaceutical and medical device litigation.