surgeon Credit: kupicoo/iStockphoto.com

Editor’s Note: The above subheading has been changed from the one that appeared in print.

Detail representatives are becoming a target in products liability and medical malpractice cases, occasionally being a named defendant alongside manufacturers, or identified for deposition or trial testimony. Courts in many jurisdictions have found that detail representatives owe no legal duty to patients or physicians under failure-to-warn principles or medical malpractice negligence theories.

Why are Manufacturer Representatives Being Named in Lawsuits?

Despite the clear lack of duty, detail representatives are being named in medical malpractice or product liability lawsuits to avoid diversity jurisdiction, in an effort to keep a case in state court. This tactic is often unsuccessful. For example, as explained by the Eleventh Circuit in Legg v. Wyeth, 428 F. 3d 1317, 1324 (11th Cir. 2005):

Quite simply, there is no reasonable basis to predict that an Alabama court would find [the detail representative], as an individual employee, personally liable for any wrongful action … in the absence of evidence that [the detail representative] either knew or should have known of [the product’s] allegedly dangerous effects.

“Dozens” of district courts throughout the country have found that detail representatives were fraudulently joined in litigation as a way to defeat diversity jurisdiction. Id. at 1320-21. See, e.g., Katie Weaver v. Am. Home Prod. Corp., n/k/a Wyeth Corp., Williette Neason, 294 F. Supp. 2d 667, 677 (E.D. Pa. 2003) (finding the detail representatives fraudulently joined). This is just one of many examples of multidistrict litigation products liability cases in which plaintiffs employed this strategy. See also, In re Rezulin Prods. Liab. Litig., 133 F. Supp. 2d 272, 288 (S.D.N.Y. 2001) (denying plaintiff’s motion to remand and finding because the detail representative did not manufacture or sell the product at issue, “there was no reasonable basis supporting that the [Alabama Extended Manufacturer’s Lability Doctrine] would impose liability on the detail representative”).

The District Court of New Jersey adopted similar reasoning in Foscue v. Zimmer, No. 09-4414, 2013 WL 4733006, at *2 (D.N.J. Sept. 3, 2013). In Foscue, the court rejected an attempt to allege claims against a non-diverse detail representative regarding a hip replacement medical device as a means to destroy diversity jurisdiction. Adopting precedent from the Eastern District of Arkansas (the state where plaintiff requested remand), which does not hold detail representatives individually liable, the New Jersey district court suggested that permitting such a cause of action to proceed was akin to “absurdity”:

[a]doption of a rule of this sort would impose upon virtually every salesperson, whether for a pharmaceutical company or other manufacturer, an independent duty to discover and warn consumers of danger in the products they promote. … Imposing a duty on sales representatives to independently verify the safety of each product they market for their employers is nothing short of absurd.

Id. (quoting Hobbs v. Wyeth, 2004 WL 6005569, at *7 (E.D. Ark. July 13, 2004) (emphasis added).

Detail Representatives are Not Sellers, Manufacturers, or Physicians

The District of New Jersey emphasized in Foscue that that the detail representative who was named as a defendant did not design or manufacture the product at issue. This is a key distinction, because detail representatives are not sellers or manufacturers of a product, and they are held to different standards than the manufacturers themselves.

Courts similarly have found that detail representatives do not owe a duty to individual patients based on a product liability or malpractice theory of liability. Attempts to name or blame the detail representative for any injuries incurred fail in many jurisdictions. The discussion below covers several examples, but only scratches the surface of the available case law on this topic.

  1. Not the Learned Intermediary

Detail representatives’ lack of duty to patients stems from the principles underlying the “learned intermediary” doctrine, which respects the specific and special nature of the doctor-patient relationship. As explained by the Hon. John Minor Wisdom of the Fifth Circuit:

This special standard for prescription drugs is an understandable exception to the Restatement’s general rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in [the] products …. Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of [the] patient. [A physician’s] task [is to weigh] the benefits of any medication against its potential dangers. The choice [a physician] makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.  Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a “learned intermediary” between manufacturer and consumer.

Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974) (emphasis added).

Using the learned intermediary as a backdrop, courts have held that manufacturers have no duty to interfere with the doctor-patient relationship. See, e.g., Labzala v. Purdue Pharma, 292 F. Supp. 2d at 1346 (S.D. Fl. 2003) (“Florida law does not impose a duty on the defendants to interfere with the physician-patient relationship, even if they are aware that the product may have been prescribed inappropriately.”); Swayze v. McNeil Labs., 807 F.2d 464, 471 (5th Cir. 1987) (“When the physician-patient relationship does exist, as here, we hesitate to encourage, much less require, a drug manufacturer to intervene in it”); Sons v. Medtronic, 915 F. Supp. 2d 776, 783 (W.D. La. 2013) (“It is well established that a medical device manufacturer is not responsible for the practice of medicine.”). This logic naturally extends to a manufacturer’s own detail representatives, whether as employees or independent contractors.

  1. No Duty to Educate/Train

While manufacturers might owe patients a duty to warn through FDA-reviewed and approved labels and package inserts, courts have clarified that this duty should not be misconstrued as a duty to educate or train physicians via detail representatives. In Rounds v. Genzyme Corp., 440 Fed. App’x 753, 756 (11th Cir. 2011), the Eleventh Circuit rejected this theory when it declined to accept plaintiff’s “attempt to circumvent the learned intermediary doctrine by characterizing the issue as one of training rather than of warning” as a “distinction without a difference.” The panel explained that the manufacturer “satisfied its duty by providing clear, unambiguous information concerning the contraindications … as well as the risks associated with it. Whether [the manufacturer] was ‘training’ or ‘warning’ of these risks when it provided him with the package insert is … an issue of semantics only.” Id. Accordingly, under this holding, detail representatives should not be required to “train” physicians how to use a product that is accompanied by sufficient FDA-approved warnings.

The Superior Court in Massachusetts has stated that “[t]he fact that individuals who have received training on medical equipment to the detriment of the patient, standing alone, is insufficient to establish a breach of duty to the injured patient on the party of the entity that provided the training. By providing the training [the manufacturer] did not become the guarantor of the competence of [those trained].” Chairman v. Sharplan Laser, No. 200000171, 2004 WL 2341569, at *7 (Mass. Super. Sept. 24, 2004). Imposing an additional duty on a detail representative to ensure the competence of doctors or surgeons using a product would be even more inappropriate.

Courts have ruled that detail representatives are not responsible for training physicians on the proper indications or use/implantation of a product or medical device. This does not stop lawsuits from including allegations that detail representatives should be liable for not stopping a surgeon mid-procedure to instruct him how to do his job.

For example, in Wolicki-Gables v. Arrow International, 641 F. Supp. 2d 1270, 1291 (M.D. Fla. 2009), affirmed, 634 F.3d 1296 (11th Cir. 2011), plaintiff alleged that the detail representative failed to instruct the surgeon how to connect the medical device in the middle of the surgical procedure, claiming that the detail representative “participated” in the surgery. The court disagreed, granting summary judgment, and stated that while the detail representative was present during the surgical 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.” Id. at 1291. The fact that the detail representative did not “scrub in” to the surgery or otherwise interact with the physician while the procedure was underway weighed in the panel’s opinion. Id.

Courts have also found that attendance at surgery does not create any additional duty on behalf of a detail representative. In Kennedy v. Medtronic, 851 N.E. 2d 778, 789 (Ill. App. Ct. 2006), the court explained that providing a medical device (pacemaker and leads) and attending a surgery does not create a duty to a patient to ensure that the product is used properly. The court stated “[i]t would be unreasonable, and potentially harmful, to require a clinical specialist [representative] … 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.” Id. Similarly, in Lemon v. Anonymous Biomet, No. CIV-07-25-R, 2008 WL 2329132, at *7 (W.D. Okla. June 3, 2008), the court rejected plaintiff’s theories that the detail representative had a duty to advise the surgeon with respect to the size and components to use with a hip replacement medical device.

In Mendez v. Shah, 28 F. Supp. 3d 282, 293 (D.N.J. 2014), in which the plaintiff asserted medical malpractice claims against the physician and product liability claims against the pharmaceutical manufacturer, the court rejected the theory that the presence of the detail representative in the operating room translated to an express statement of the fitness of the product. This is not the accepted reasoning in all jurisdictions. Compare Medtronic v. Malander, 2013 Ind. App. LEXIS 499 (Ind. Ct. App. Oct. 11, 2013) (finding the detail representative’s presence during the surgery and discussion with the surgeon sufficient to deny summary judgment).

The principles behind the learned intermediary doctrine extend to liability of detail representatives in the medical malpractice realm, as well. For example, in Hall v. Horn Medical, Civ. Action No. 11-1032, 2012 WL 1752546, at *3 (E.D. La., May 16, 2012), the court rejected the physician’s argument that he relied on the detail representative’s statements with respect to the use of a cage device during a spinal surgery as “unreasonable as a matter of law.” The court explained that “[a]s a seasoned neurosurgeon, it is patently unreasonable for [the doctor] to rely on a sales representative’s opinion about the type of procedure that should be employed in operating on a patient’s spine.” Id. See also, Kennedy v. Medtronic, 851 N.E. 2d at 789 (discussed above, and also involving medical malpractice claims.)

Conclusion

While detail representatives may find themselves more involved in product liability, mass tort and medical malpractice lawsuits, many jurisdictions agree that, under normal circumstances, there is no basis for individual liability, and representatives do not owe a legal duty to individual patients or to surgeons.

 

Michael C. Zogby is a partner with Drinker Biddle and Reath in Florham Park. He is co-chair of the Products Liability and Mass Tort Group and co-chair of the firm’s Pharma and Life Sciences Group.  Daryl Daly is an associate at the firm. She represents major pharmaceutical and medical device companies in products liability cases.