[The following was originally published in Westlaw Journal Pharmaceuticals. It is reprinted here with permission © 2014 Thomson Reuters.]
In recent years, causes of action for “failure to train,” or allegations predicated on a duty to train, have been on the rise in cases against medical device manufacturers. Historically, however, such claims and allegations have made relatively few appearances in the case law – even fewer in the context of prescription products. Where they have arisen, the case law seems to have congealed into three approaches. First are cases refusing to recognize a duty to train or, conversely, allowing a “failure to train” claim as a mere derivative of a “failure to warn” claim. Second are cases either allowing or disallowing such claims as a form of an educational malpractice cause of action. Third are cases – specifically involving a PMA-approved medical device – either recognizing or denying that such claims are preempted by the Food, Drug, and Cosmetic Act (“FDCA”). Each approach is outlined briefly below.
Failure to Train v. Failure to Warn
Some courts consider any alleged duty to train as a novel allegation with no basis in law. Probably the most prominent example comes from the Minnesota Supreme Court, and involves an aircraft, rather than a medical device. In Glorvigen, the plaintiffs brought suit against the manufacturer of a private plane on behalf of the owner/pilot and his passenger, who had died when the plane crashed. Glorvigen v. Cirrus Design Corp., 816 N.W.2d 572 (Minn. 2012). Plaintiffs alleged that the plane manufacturer’s two-day “transition training,” (in which an experienced pilot’s previous training and experience is built upon to familiarize him with the new plane), failed to train the pilot on precisely the maneuver he would have needed to avoid the crash. The court rejected this theory, holding that “[t]he duty to warn has never before required the supplier or manufacturer to provide training, only to provide accurate and thorough instructions on the safe use of the product ….” Id. at 582. “[T]o hold now that [defendant] must provide training would either create a new common law duty to train or expand the duty to warn to include training … [which] would require an unprecedented expansion of the law.” Id. at 583.
The alleged duty to train has been rejected in the medical device context, as well. See, e.g., Woodhouse v. Sanofi-Adventis U.S. LLC, 2011 WL 3666595 at *3 (W.D. Tex. June 23, 2011) (allegation that defendant “failed to train, warn or educate” physicians failed to state a plausible claim because no such duty exists). In doing so, courts often point out that such a duty is not only novel, it would also impermissibly interfere with the physician/patient relationship: “It is well established that a medical device manufacturer is not responsible for the practice of medicine.” Sons v. Medtronic, Inc., 915 F. Supp. 2d 776, 783 (W.D. La. 2013); see also Wolicki-Gables v. Arrow Int’l, Inc., 641 F. Supp. 2d 1270 (M.D. Fla. 2009), aff’d, 634 F.3d 1296 (11th Cir. 2011) (no affirmative duty to advise physician how to use product; physician must utilize product according to his medical judgment). In such cases, the alleged failure to train is often characterized as an inept attempt to expand the duty to warn. See, e.g., Rounds v. Genzyme Corp., 2011 WL 3925353 at *3 (11th Cir. Sept. 8, 2011) (“[Plaintiffs] attempt to circumvent the learned intermediary doctrine by characterizing the issue as one of training rather than of warning …. This is a distinction without a difference. … [Defendant] satisfied its duty … by providing clear, unambiguous information concerning the contraindications for [the product], as well as the risks associated with it. Whether [defendant] was ‘training’ or ‘warning’ [the treater] of these risks when it provided him the package insert is … an issue of semantics only.”). Moreover, as the Fifth Circuit observed, “[i]t is both impractical and unrealistic to expect drug manufacturers to police individual operating rooms to determine which doctors adequately supervise their surgical teams.” Swayze v. McNeil Labs., Inc., 807 F.2d 464, 468 (5th Cir. 1987).
Some cases reject liability for failure to train even where that duty to train has been voluntarily assumed. Chamian provides a good example of the underlying rationale: “The fact that individuals who have received training on medical equipment subsequently misuse the equipment to the detriment of a patient, standing alone, is insufficient to establish a breach of a duty to the injured patient on the part of the entity that provided the training. By providing training, [defendant] did not become a guarantor of the competence of [those it trained.]” Chamian v. Sharplan Lasers, Inc., 2004 WL 2341569 at *7 (Mass. Super. Ct. Sept. 24, 2004). Other cases allow for the assumption of the duty to train: “A medical device manufacturer does not automatically have a duty to properly train, instruct or assist a physician on the surgical implantation and use of the device. However, the manufacturer can affirmatively undertake that duty ….” Lemon v. Anonymous Physician, 2005 WL 2218359 at *2 (S.D. Ind. 2005); see also Restatement (2d) Torts, § 324A, Liability to Third Person for Negligent Performance of Undertaking.
Finally, some courts have allowed “failure to train” claims to proceed as an unremarkable sub-species of a failure to warn claim. For example, in a case involving an implantable medical device called the “Virtue” urethral sling, the court held that “Defendants’ alleged marketing of the Virtue device for non-FDA-approved purposes, combined with failing to warn customers or train and educate physicians about the device, once they knew about potentially adverse side effect, qualified under failure to provide adequate warnings or instructions.” Lautzenhiser v. Coloplast A/S, 2012 WL 4530804 at *4 (S.D. Ind. Sept. 29, 2012).
Failure to Train As Tantamount to Educational Malpractice Claim
Some courts have analyzed “failure to train” claims under the rubric of “educational malpractice,” a largely discredited theory that attempted to hold educational institutions liable – either by their students or third-parties allegedly harmed by their students – for doing their jobs poorly. This has arisen primarily in the aviation context. Thus, in Sheesley, plaintiffs were representatives of airplane passengers killed in a crash allegedly caused by the pilot’s poor training. Sheesley v. Cessna Aircraft Co., 2006 WL 1084103 (D.S.D. April 20, 2006). The court held that “[t]he gravamen of plaintiffs’ claims are that [defendant] negligently trained [the pilot] by failing to provide him the skills and training necessary …. Further, plaintiffs contend that [defendant] used negligent teaching techniques …. In other words, plaintiffs are contesting the substance and manner of [defendant’s] training. Plaintiffs’ claims encompass the traditional aspects of education, and thus sound in educational malpractice.” Id. at *16-*17. Such claims, the court found, were not cognizable. Id.
On the other hand, other courts have found that the public policy rationales behind the refusal to recognize an educational malpractice claim – such as the lack of a satisfactory standard of care, the vagaries of external causes affecting a student’s failure to learn, and the potential of court involvement in day-to-day school operations – do not extend beyond traditional educational institutions. Thus, in Newman, the court held that a failure to train claim brought against a flight training school was not an educational malpractice claim, and could thus proceed. Newman v. Socata SAS, 924 F. Supp. 2d 1322, 1329-30 (M.D. Fla. 2013). “Allowing the claims at issue – that a for-profit commercial entity, teaching a narrowly structured course on the operation of a specific type of aircraft, owed and breached a duty to warn and train regarding a known lethal propensity of the aircraft to torque roll – to proceed does not implicate the public policy concerns [barring educational malpractice claims].” Id. at 1329. Such a result is likely distinguishable in the medical device context, however, because it does not involve a “learned intermediary” physician, who is already an expert in the field and is under an independent professional duty to use any such device pursuant to the standard of care.
Preemption of Failure to Train
When failure to train claims involve devices approved pursuant to the FDA’s rigorous pre-market approval (“PMA”) process, some courts have held that such claims are preempted by the FDCA because they would constitute a state requirement different from or additional to the federal requirements. See, e.g., Rollins v. St. Jude Med. Diag. Div., Inc., 442 F.3d 919, 929-33 (5th Cir. 2006) (state law duty to train medical personnel in use of PMA device preempted as state requirement additional to FDA regulatory scheme). Of course, this analysis does not apply where the defendant fails to provide training mandated by the FDA’s PMA approval. See, e.g., Chao v. Smith & Nephew, Inc., 2013 WL 6157587 at *3-*4 (S.D. Cal. Oct. 22, 2013). Moreover, other courts have held that interaction between sales representatives and physicians is outside the ambit of FDA regulation, and thus failure to train claims escape federal preemption. See, e.g., Medtronic, Inc. v. Malander, 996 N.E.2d 412, 419 (Ind. Ct. App. 2013).
If a rational conclusion can be discerned from the foregoing, it is perhaps that the most thoughtful opinions in the medical device context recognize that failure to train claims interfere with the practice of medicine, and would require an impractical duty on the part of medical device manufacturers to “oversee” doctors in their operating rooms and offices. The unique aspects of the doctor-patient relationship thus help to distinguish cases – such as aviation cases analyzed under educational malpractice theory – that find against the defendant. That analysis, however, is complicated when a manufacturer voluntarily trains the physician, and thus potentially undertakes a duty to do so reasonably. Arguably, the “learned intermediary” doctrine should prevail over the voluntary assumption of a duty, but that remains to be hashed out in the case law. Considering that courts have come out on both sides of what should be a straightforward application of the preemption doctrine, the courts’ ongoing treatment of the voluntary assumption question is likely to remain mixed as well.
Image courtesy of Flickr by Artur Bergman.