Dearinger v. Eli Lilly & Co.

510 P.3d 326

Certification from the United States District Court for the Western District of Washington in

David J. DEARINGER, and Ganna P. Dearinger, individually and the marital community composed thereof, Petitioners- Plaintiffs,

v.ELI LILLY AND COMPANY, a Corporation, Respondent-Defendant.

No. 99956-2

certified 2:21-cv-00060-JCC

Supreme Court of Washington.

Argued February 10, 2022

Filed June 2, 2022

Kainui Michael Smith, Attorney at Law, 1420 5th Ave., Ste. 3400, Seattle, WA, 98101-4010, Anne Marie Talcott, Schwabe Williamson & Wyatt, 1211 Sw 5th Ave., Ste. 1600, Portland, OR, 97204-3715, Michael X. Imbroscio, Daniel C. Eagles, Emily S. Ullman, Covington & Burling LLP, One City Center, 850 Tenth Street Nw, Washington, DC, 20001, Paul W. Schmidt, Covington & Burling LLP, The New York Times Building, 620 Eighth Avenue, New York, NY, 10018, for Defendant.

Michael Barr King, Rory Drew Cosgrove, Tierney Elizabeth Vial, Carney Badley Spellman PS, 701 5th Ave., Ste. 3600, Seattle, WA, 98104-7010, for Amicus Curiae on behalf of Pharmaceutical Research and Manufacturers of America.

Valerie Davis McOmie, Attorney at Law, 4549 Nw Aspen St., Camas, WA, 98607-8302, Daniel Edward Huntington, Richter-Wimberley PS, 422 W. Riverside Ave., Ste. 1300, Spokane, WA, 99201-0305, for Amicus Curiae on behalf of Wa State Assoc. for Justice Foundation.

Noah Jaffe, Nicoll Black & Feig PLLC, 1325 4th Ave., Ste. 165, Seattle, WA, 98101-2506, Daniel L. Syhre, Betts, Patterson & Mines, PS, 701 Pike St., Ste. 1400, Seattle, WA, 98101-3927, for Amicus Curiae on behalf of Wa Defense Trial Lawyers Assoc.

OWENS, J.—

¶ 1 Under the learned intermediary doctrine, a prescription drug manufacturer satisfies its duty to warn patients of a drug's risks when it adequately warns the prescribing physician. The United States District Court for the Western District of Washington asks us via certified question whether Washington law recognizes an exception to the learned intermediary doctrine when a prescription drug manufacturer advertises its product directly to consumers. We answer this question in the negative: there is no direct-to-consumer advertising exception. The policies underlying the learned intermediary doctrine remain intact even in the direct-to-consumer advertising context. Further, existing state law sufficiently regulates product warnings and prescription drug advertising. Accordingly, we hold regardless of whether a prescription drug manufacturer advertises its products directly to consumers, the manufacturer satisfies its duty to warn a patient when it adequately warns the prescribing physician of the drug's risks and side effects.

I. FACTS AND PROCEDURAL HISTORY

¶ 2 Plaintiff David Dearinger alleges he suffered a hemorrhage leading to a stroke that caused him permanent disabilities less than two hours after consuming Cialis. Cialis is a prescription drug manufactured by defendant Eli Lilly and Co. (Lilly) to treat prostatic hyperplasia, pulmonary arterial hypertension, and erectile dysfunction.

¶ 3 Dearinger sued Lilly in federal court under the Washington products liability act (WPLA), chapter 7.72 RCW, for negligent design, negligent failure to warn, and breach of warranty.¹ The theory central to Dearinger's claims is that Lilly knew or should have known Cialis presented a risk of stroke to its users and failed to adequately warn users of this risk.

¶ 4 Lilly moved to dismiss the complaint, claiming it provided adequate warnings to Dearinger's prescribing physician under the learned intermediary doctrine. In response, Dearinger claimed there is an exception to the learned intermediary doctrine for drug manufacturers who advertise directly to consumers. But no Washington court has considered this exception. Accordingly, Dearinger moved for the United States District Court to certify a question to this court asking whether Washington law recognizes such an exception, which the court granted.

¶ 5 Three amicus curiae submitted briefs. The Washington State Association for Justice Foundation (WSAJF) filed a brief in support of Dearinger, while the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Washington Defense Trial Lawyers submitted briefs supporting Lilly. Additionally, counsel for WSAJF and PhRMA presented oral argument before the court.

II. CERTIFIED QUESTION PRESENTED ²

¶ 6 Does Washington law recognize an exception to the learned intermediary doctrine that requires prescription drug manufacturers to warn patients, not just prescribing physicians, when the manufacturer directly advertises to consumers? We review certified questions de novo. In re F5 Networks, Inc. , 166 Wash.2d 229, 236, 207 P.3d 433 (2009).

III. ANALYSIS

A. The Learned Intermediary Doctrine Is Settled Law in Washington

1. Washington Adopted the Doctrine through the Common Law

¶ 7 This case ultimately centers on product liability, which is governed by the WPLA. Under the WPLA, a product manufacturer may be liable for failing to provide adequate warnings about a product if it harms the user. RCW 7.72.030(1). Thus, a manufacturer has a duty to warn of dangers associated with using a particular product. Id. This case raises the question of who the manufacturer must warn.

¶ 8 In the context of prescription drugs, the learned intermediary doctrine provides "the manufacturer satisfies its duty to warn the patient of the risks of its product where it properly warns the prescribing physician." Taylor v. Intuitive Surgical, Inc. , 187 Wash.2d 743, 757, 389 P.3d 517 (2017) (citing Terhune v. A.H. Robins Co. , 90 Wash.2d 9, 14, 577 P.2d 975 (1978) ). In other words, "[t]he manufacturer's duty to provide warnings to patients transfers to the doctor, who is in a better position to communicate them to the patient." Id.

¶ 9 The learned intermediary doctrine has been a fixed part of Washington law since this court adopted it in Terhune in 1978. Courts applying the learned intermediary doctrine have done so without recognizing an exception. See Sherman v. Pfizer, Inc. , 8 Wash. App. 2d 686, 440 P.3d 1016 (2019), review denied , 194 Wash.2d 1015, 452 P.3d 1241 (2019) ; see also Luttrell v. Novartis Pharm. Corp. , 894 F. Supp. 2d 1324, 1342 (E.D. Wash. 2012) (court order), aff'd , 555 F. Appx 710 (9th Cir. 2014). Indeed, we have consistently reiterated Terhune ’s central principle that a manufacturer satisfies its duty to warn patients of product risks by warning the prescribing physician, who then takes on the responsibility of communicating those warnings to the patient. Taylor , 187 Wash.2d at 757-58, 389 P.3d 517 ; Young v. Key Pharm., Inc. , 130 Wash.2d 160, 168, 922 P.2d 59 (1996) (plurality opinion); Ruiz-Guzman v. Amvac Chem. Corp. , 141 Wash.2d 493, 506, 7 P.3d 795 (2000) ; Rublee v. Carrier Corp. , 192 Wash.2d 190, 208-09, 428 P.3d 1207 (2018).

¶ 10 Washington is far from alone in adopting the learned intermediary doctrine. Every state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration. See Br. of Resp't at 47-66; Centocor, Inc. v. Hamilton , 372 S.W.3d 140, 158 n.17 (Tex. 2012) (collecting cases). Thus, not only is the learned intermediary doctrine a fixed part of Washington law, it is also universally followed across the country.

2. The WPLA Neither Abrogates the Doctrine nor Provides for an Advertising Exception

¶ 11 While Dearinger and Lilly recognize the learned intermediary doctrine as an active part of our state's common law, WSAJF argues the learned intermediary doctrine is contrary to the WPLA's text and is either ineffective or limited in scope and therefore inapplicable in the context of direct-to-consumer advertising. WSAJF claims "the WPLA's plain language requires product warnings be given directly to consumers." Br. of WSAJF at 14. In effect, WSAJF argues the WPLA abrogates our common law embrace of the learned intermediary doctrine or otherwise modifies the doctrine to warrant an advertising exception.

¶ 12 To abrogate the common law, there must be "clear evidence of the legislature's intent to deviate from the common law." Potter v. Wash. State Patrol , 165 Wash.2d 67, 77, 196 P.3d 691 (2008). Such intent may be evident where "the provisions of a later statute are so inconsistent with and repugnant to the prior common law that both cannot simultaneously be in force." State ex rel. Madden v. Pub. Util. Dist. No. 1 of Douglas County , 83 Wash.2d 219, 222, 517 P.2d 585 (1973). The WPLA itself recognizes this principle, stating, "The previous existing applicable law of this state on product liability is modified only to the extent set forth in this chapter." RCW 7.72.020(1).

¶ 13 We adopted the learned intermediary doctrine in Terhune three years before the legislature enacted the WPLA. Accordingly, the learned intermediary doctrine is previous existing applicable law under RCW 7.72.020(1). We look to the four provisions cited by WSAJF to determine whether the WPLA modifies the learned intermediary doctrine by use of inconsistent language.

¶ 14 First, WSAJF cites RCW 7.72.010(4), which provides a "product liability claim" includes, among other things, claims for harm caused by "warnings" or "marketing." On its face, this provision does not modify the learned intermediary doctrine. The learned intermediary doctrine itself recognizes a product liability claim for inadequate warnings. Thus, RCW 7.72.010(4) tells us what we already know. More notable is what this provision does not say, namely, that warnings or marketing must be directed at a consumer. Because this provision does not alter a manufacturer's duty to warn, it provides no basis for an exception to the learned intermediary doctrine.

¶ 15 Second, WSAJF relies on RCW 7.72.030(1)(b), which states a product may not be reasonably safe if adequate warnings were not provided with the product when the manufacturer could have provided the warnings or instructions that the claimant alleges would have been adequate. Like...