Today’s guest post comes from Iowa born and bred attorney Stephanie Koltookian along with Tom Joensen and Tom Kus, all of Faegre Drinker. The backstory is that Stephanie sent Bexis a note that the Blog should not just necessarily assume that Iowa would adopt the learned intermediary rule, since the state’s high court had yet to do so. After some back and forth, Bexis invited Stephanie to write on that subject, since it was obvious she knew more about it than Bexis did. Stephanie agreed, and this post is the result. As always, our guest posters deserve 100% of the credit (and any blame) for their work.
A recent post on this blog stated that the learned-intermediary doctrine” had “been adopted by every state other than West Virginia.” [ed note: West Virginia adopted the doctrine by statute] That struck me as not quite accurate. Several states continue to have no state appellate authority adopting the doctrine because the issue has never been presented to the state court.
Why do I care about this overgeneralization? One of the states with no controlling decision (or any state court decision directly addressing the doctrine) is my own — Iowa. See Nicholson v. Biomet, Inc., No. 18-CV-3057-CJW-KEM, 2020 WL 3399899, at * 15 (N.D. Iowa Mar. 6, 2020) (“Iowa courts have not explicitly adopted the learned intermediary doctrine.”).
The absence of a controlling state court decision in states like Iowa has left open the door for crafty plaintiffs’ counsel to argue that the learned intermediary doctrine should not be applied or should be given a narrow interpretation. See, e.g., Kelly v. Ethicon, No. 20-CV-2036-CJW-MAR, 2020 WL 6120155, at * 6–8 (N.D. Iowa Oct. 16, 2020) (analyzing plaintiffs’ challenge to the application of the learned intermediary doctrine under Iowa law and its scope). Although such attempts have been unsuccessful, the lack of certainty leads to additional briefing, costs, and uncertainty for medical device and pharmaceutical clients.
Defense attorneys should work to get Iowa off the list of states with no controlling authority on the learned intermediary doctrine. Then we can focus on Iowa’s best attributes — the Iowa State Fair, the Field of Dreams, and pigs outnumbering people.
In true Iowa-nice fashion, this blog post provides one roadmap why Iowa should adopt and apply the learned intermediary doctrine in medical device cases that has been successful in Iowa federal courts. This belt-and-suspenders approach can be adjusted to apply to most states that have not yet formally adopted the doctrine. And that’s our end goal — to strengthen and broaden the adoption of learned intermediary doctrine.
Iowa has a good foundation to support the adoption of the learned intermediary doctrine. Although it has never directly adopted the doctrine, the Iowa Supreme Court has: (1) identified the learned intermediary doctrine as one example of a “‘no duty’ rule in the warning area based on principles analogous to lack of control,” see McCormick v. Nikkel & Assocs., Inc., 819 N.W.2d 368, 375 (Iowa 2012); (2) cited favorably to the provision of the Restatement (Third) of Torts: Products Liability that endorses the learned intermediary doctrine, see Thompson v. Kaczinski, 774 N.W.2d 829, 835 (Iowa 2009); and (3) referenced the open issue presented by the learned intermediary doctrine, see Huck v. Wyeth, Inc., 850 N.W.2d 353, 360 & 360 n.4 (Iowa 2014) (stating that the learned intermediary doctrine, and if it applied, were not at issue on appeal in a prescription drug case).
Federal courts have unanimously predicted that Iowa will adopt the doctrine. See, e.g., Madsen v. Am. Home Prods. Corp., 477 F. Supp. 2d 1025, 1034 (E.D. Mo. Mar. 7, 2007) (applying Iowa law); Nicholson, 2020 WL 3399899, at * 15; see also Petty v. United States, 740 F.2d 1428, 1440 (8th Cir. 1984) (stating the learned intermediary doctrine is part of Iowa’s common law).
Iowa’s adoption of the learned intermediary doctrine would fall in line with the majority of jurisdictions that employ some iteration of the learned intermediary doctrine. “In 2012, the Texas Supreme Court counted thirty-five states, including the District of Columbia, in which the high court has ‘adopted some form of the learned intermediary doctrine within the prescription drug product-liability context’ or that has at least ‘cited favorably to its application within this context.’” Tyree v. Boston Scientific Corp., 56 F. Supp. 3d 826, 834 n. 3 (S.D. W. Va. 2014) (citation omitted). Further, “state intermediate courts or federal courts of thirteen other states have applied the learned intermediary doctrine or predicted that the highest state court would apply it.” Id. (citations omitted). Likewise, “[i]n In re Norplant [Contraceptive Products Liability Litigation, 215 F. Supp. 2d 795 (E.D. Texas 2002)], the court determined that 48 states, the District of Columbia and Puerto Rico apply the learned intermediary doctrine to define a pharmaceutical company’s duty to warn of risks associated with the use of a prescription drug.” Madsen, 477 F. Supp. 2d at 1033–34. [ed. note: for a constantly updated list of these states see here]
Arguments in favor of applying the learned intermediary doctrine are compelling in implantable medical device cases. Under the learned intermediary doctrine, the duty to warn runs to the treating physician because “physicians are in a better position to convey information to patients than manufacturers.” See id. at 1033. For a patient to use a prosthetic device, she must find an orthopedic surgeon to implant it using the surgeon’s superior knowledge to perform the surgery. The surgeon therefore “acts as a ‘learned intermediary’ between the manufacturer and the ultimate consumer and assumes responsibility for advising individual patients of the risks associated with the [device].” See id. Indeed, under Iowa law, “a doctor recommending a particular procedure generally has, among other obligations, the duty to disclose to the patient all material risks involved in the procedure.” Pauscher v. Iowa Methodist Med. Ctr., 408 N.W.2d 355, 358 (Iowa 1987) (emphasis added). Thus, any warnings provided directly to a patient by the device manufacturer are redundant.
Additionally, adoption of the learned intermediary doctrine would be consistent with Iowa’s sophisticated user defense. See West v. Broderick & Bascom Rope Co., 197 N.W.2d 202, 210 (Iowa 1972) (applying sophisticated user defense). The sophisticated user defense imposes “no duty to warn if the user knows or should have known of the potential danger, especially when the user is professional who should be aware of the characteristics of the product.” See Bergfeld v. Unimin Corp., 319 F.3d 350, 353 (8th Cir. 2003) (applying Iowa law). The sophisticated user defense is effectively a generalization to all products of the learned intermediary doctrine, which holds that a medical device warning should be directed to the person who would act on the warning–the doctor who will select and implant the device. Courts applying Iowa law have blurred the line between the two doctrines. See e.g., Daughetee, 960 F. Supp. 2d at 870 (“Restatement (Third) § 2(c) and comment i recognize a defense to a warning defect claim based on the duty of an intermediary–and not even necessarily a ‘learned’ or ‘sophisticated’ intermediary–to warn the end user.”).
In accordance with McCormick, Daughetee, the sophisticated user defense Iowa has already adopted, and the conclusions of the vast majority of jurisdictions, Iowa state courts should agree with the Erie predictions of several federal courts and adopt the learned intermediary doctrine.
And that’s our story and we’re sticking to it.