Despite West Virginia's longstanding rejection of the learned intermediary doctrine, defendant Boston Scientific Corp. earned a surprise win in one of the more than 60,000 pelvic mesh MDL lawsuits currently pending before Judge Joseph Goodwin in the United States District Court for the Southern District of West Virginia. In Tyree v. Boston Scientific Corp., No. 2:12-cv-08633, 2014 U.S. Dist. LEXIS 151397 (S.D. W. Va. Oct. 23, 2014), the court granted Boston Scientific's motion in limine to preclude four consolidated plaintiffs from arguing that Boston Scientific owed them any direct duty under West Virginia law. In reaching this decision, the court distinguished the West Virginia Supreme Court of Appeals' rejection of the learned intermediary doctrine in State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007), and concluded that, on the facts of this case, Boston Scientific's duty to warn ran to the plaintiffs' doctors under the learned intermediary doctrine, not to the plaintiffs themselves. Tyree, 2014 U.S. Dist. LEXIS 151397, at *21–22. Given the ostensible tension between this recent decision and West Virginia's historic antagonism of the learned intermediary defense, a brief history is in order.
In the wake of two West Virginia federal decisions advising that the state likely would adopt the learned intermediary doctrine, a divided panel of West Virginia's highest court—the West Virginia Supreme Court of Appeals—held just the opposite in Karl. Compare Ashworth v. Albers Med., Inc., 395 F. Supp. 2d 395 (S.D. W. Va. 2005) (predicting that West Virginia would adopt the learned intermediary doctrine), and Pumphrey v. C.R. Bard, Inc., 906 F. Supp. 334 (N.D. W. Va. 1995) (same), with Karl, 647 S.E.2d at 914 (majority opinion, rejecting the learned intermediary doctrine in West Virginia). In Karl, as in Tyree, the pharmaceutical defendant, Janssen Pharmaceuticals, advocated for adoption of the learned intermediary doctrine and moved in limine to preclude the plaintiffs from presenting evidence or argument that Janssen owed any duty to warn the plaintiffs' decedent about the dangers of Propulsid®, the medicine her doctor prescribed. Based on an apparent disgust with the proliferation of direct-to-consumer advertising by prescription drug companies, a majority of the court rejected this argument, which was a matter of first impression in the West Virginia state courts. After quibbling with the number of states that have formally adopted the learned intermediary doctrine, the majority determined that the doctrine was "largely outdated" in an age when pharmaceutical companies advertise directly to consumers, who then take an active role in their own healthcare decisions. Karl, 647 S.E.2d at 903–06, 909–11. Finding that West Virginia public policy could not stand for an adoption of the learned intermediary doctrine, the court concluded that "under West Virginia products liability law, manufacturers of prescription drugs are subject to the same duty to warn consumers about the risks of their products as other manufacturers." Karl, 647 S.E.2d at 914; see also id. at 918 (Maynard, J., concurring) (noting the "bad policy" that would result with adoption of the learned intermediary doctrine); id. (Starcher, J., concurring) ("[T]he learned intermediary doctrine is a bad public policy that is so laced with contradictions, caveats and exceptions that it is impossible to apply the doctrine fairly and consistently.").
Two justices dissented in Karl, aptly noting the overbreadth of the majority opinion, which improperly assumed, without reason, that all pharmaceutical companies advertise all medicines directly to consumers. Karl, 647 S.E.2d at 914–15 (Albright, J., dissenting) ("What the majority overlooks by emphasizing the direct marketing of drugs to consumers is that the doctrine may still serve a useful purpose for prescription drugs that are not heavily marketed and in those circumstances where a physician's expertise is relied upon . . . ."). Indeed, in the case at hand, the majority and concurring opinions paid no attention as to whether or not their concerns about direct-to-consumer marketing, in fact, had any bearing on the decedent's decision to use the medicine at issue. In light of the case-specific nature of these types of inquiries, the dissenting justices found the wholesale rejection of the learned intermediary doctrine "both precipitous and unwarranted." Karl, 647 S.E.2d at 917.
In the wake of Karl, only a few West Virginia federal courts have been tasked with determining its scope. As set forth in Judge Goodwin's recent decision in Tyree, this has not always led to uniform, or predictable, results. See Tyree, 2014 U.S. Dist. LEXIS 151397, at *15. Some courts have interpreted the Karl decision narrowly, limiting the majority's rejection of the learned intermediary doctrine to the specific facts of that case. For example, in Roney v. Gencorp, the Southern District of West Virginia found that "[t]he reasoning [of Karl] is not applicable to a scenario outside the prescription pharmaceutical context and the risk of direct-to-consumer advertising." 654 F. Supp. 2d 501, 505 (S.D. W. Va. 2009) (finding that, despite Karl, West Virginia might apply the sophisticated user defense in an appropriate case). In the same vein, in Vagenos v. ALZA Corp., the Southern District determined that West Virginia would allow a pharmacy to invoke the learned intermediary doctrine as a defense to failure-to-warn claims. No. 1:09-cv-1523, 2010 U.S. Dist. LEXIS 75020, at *3–4 (S.D. W. Va. July 23, 2010). More recently, in Muzichuck v. Forest Laboratories, Inc., the Northern District of West Virginia rejected the learned intermediary doctrine, invoking Karl in a case where the manufacturer did not engage in direct-to-consumer marketing of the medicine that allegedly caused the decedent to commit suicide. No. 1:07-cv-16, 2014 U.S. Dist. LEXIS 95607 (N.D. W. Va. July 15, 2014) ("In Karl, the West Virginia Supreme Court of Appeals did not distinguish between cases that present evidence of direct-to-consumer advertising and those that do not."); cf., e.g., Woodcock v. Mylan, Inc., 661 F. Supp. 2d 602 (S.D. W. Va. 2009) (holding, in choice-of-law dispute, that West Virginia's rejection of the learned intermediary doctrine applied even to out-of-state plaintiff's failure-to-warn claims, regardless of any analysis of whether defendants engaged in direct-to-consumer marketing), overruled by statute, W. Va. Code. § 55-8-16 (2011) ("[T]he duty to warn shall be governed solely by the product liability law of the place of injury.").
Against this backdrop, the court's October 2014 decision in Tyree came as a welcome surprise. In concluding that Boston Scientific could take advantage of the learned intermediary doctrine in Tyree, the court limited Karl squarely to its facts and focused on two key distinguishing factors. First, Judge Goodwin found that the Karl court's emphasis on direct-to-consumer advertising had no place in Tyree, as there was no evidence to suggest that Boston Scientific ever engaged in such marketing efforts. See, e.g., Tyree, 2014 U.S. Dist. LEXIS 15137, at *18. Judge Goodwin was persuaded that, without direct-to-consumer advertising, patients again are left to rely upon their doctors to make appropriate treatment decisions, which is the very premise upon which the learned intermediary doctrine is based. Second, unlike Karl, which was a case about a prescription medication, Tyree involved the sale and implantation of a medical device—the Obtryx sling. Justifiably, Judge Goodwin was persuaded that, regardless of the propriety of applying the learned intermediary doctrine to drug manufacturers, medical device companies stand in a different position vis-à-vis consumers who need their products. Unlike medications, which may be obtainable from other sources, medical devices like the sling at issue may only be obtained and implanted by licensed physicians. Moreover, because such devices are surgically implanted, "the patient and . . . physician must thoroughly discuss the potential risks and benefits prior to the implantation." Tyree, 2014 U.S. Dist. LEXIS 15137, at *21. Accordingly, doctors, rather than medical device companies, are in the best position to relay important risk information to patients, again harkening back to the very bedrock of the learned intermediary doctrine.
In allowing a learned intermediary defense in Tyree, Judge Goodwin aligned his decision with the laws of at least 48 other states. Tyree, 2014 U.S. Dist. LEXIS 15137, at *6 n.3 (identifying Wisconsin and New Mexico as possible outliers); id. at *21. Although Judge Goodwin's holding does not create binding authority in the state courts of West Virginia (or anywhere else, for that matter), his analysis is both a step in the right direction and exactly the type of analysis in which the West Virginia Supreme Court of Appeals should have, but did not, engage in Karl. Binding or not, his opinion provides a ray of hope to defendants trying to navigate the murkiness that has been left in the wake of Karl.
Keywords: litigation, products liability, pelvic mesh implant, learned intermediary doctrine, duty to warn
Copyright © 2018, American Bar Association. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or downloaded or stored in an electronic database or retrieval system without the express written consent of the American Bar Association. The views expressed in this article are those of the author(s) and do not necessarily reflect the positions or policies of the American Bar Association, the Section of Litigation, this committee, or the employer(s) of the author(s).