THE HONORABLE JOHN C. COUGHENOUR 1 2 3 4 5 6 UNITED STATES DISTRICT COURT 7 WESTERN DISTRICT OF WASHINGTON 8 AT SEATTLE 9 DAVID DEARINGER and GANNA CASE NO. C21-0060-JCC DEARINGER, 10 ORDER 11 Plaintiff, 12 v. 13 ELI LILLY AND COMPANY ,
14 Defendants. 15
17 This matter comes before the Court on Defendant Eli Lilly and Company’s motion to 18 dismiss for failure to state a claim (Dkt. No. 14). Having thoroughly considered the briefing and 19 the relevant record, the Court hereby GRANTS Defendant’s motion (Dkt. No. 14) and 20 DISMISSES Plaintiffs’ complaint without prejudice for the reasons explained below. 21 I. BACKGROUND 22 Plaintiffs allege that in 2018, Mr. Dearinger suffered an intracerebral hemorrhage leading 23 to a paralytic stroke within two hours of taking Cialis, a prescription drug that Defendant 24 manufactured and sold. (Dkt. No. 10 at 4.) Cialis is used to treat erectile dysfunction, enlarged 25 prostate symptoms, and pulmonary arterial hypertension. (Id.) Plaintiffs claim that, as a result of 26 this stroke, Mr. Dearinger suffered permanent loss of sensory and motor function of the left side 1 of his body. (Id.) They assert five causes of action under Washington’s Products Liability Act, 2 (Chapter 7.72 RCW): (1) design defect; (2) failure to warn at the time of manufacture; (3) failure 3 to warn after manufacturing; (4) breach of warranty; and (5) loss of consortium. (Dkt. No. 10 at 4 7–11.) Plaintiffs allege Defendant knew or should have known Cialis presented a risk of 5 paralytic stroke and failed to adequately warn of this risk. (Id. at 7–10.) Plaintiffs claim that 6 Cialis’s label does not adequately warn of the risk of cerebrovascular events because it warns of 7 the risk of stroke only in the context of “cardiovascular events.” (Dkt. No. 32 at 5.) 8 In April 2021, Defendant filed a motion to dismiss for failure to state a claim. (Dkt. No. 9 14 at 9). It argued, among other things, that under the learned intermediary doctrine, any duty to 10 warn was owed only to Mr. Dearinger’s prescribing physician, such that adequately pleading the 11 claim requires alleging that the doctor would have taken a “different course of action” had 12 Defendant provided a different warning. (Id.) Plaintiffs responded urging the Court to adopt an 13 exception to this doctrine for prescription drugs marketed directly to consumers, (Dkt. No. 25 at 14 12), and the Court certified the question to the Washington State Supreme Court. (Dkt. No. 28.) 15 The Supreme Court declined to recognize this exception and held that the learned intermediary 16 doctrine applies to prescription drugs marketed directly to consumers. (Dkt. No. 30-1 at 19.) The 17 parties then each submitted additional briefs (Dkt. Nos. 32, 34). 18 II. DISCUSSION 19 A. Legal Standard 20 To survive a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), “a 21 complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is 22 plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. 23 Twombly, 550 U.S. 544, 570 (2007)). A claim has facial plausibility when the plaintiff pleads 24 factual content that allows the court to draw the reasonable inference that the defendant is liable 25 for the misconduct alleged. Id. The Court accepts as true all material allegations of fact and 26 construes the complaint in a light “most favorable to the non-moving party,” however merely 1 “conclusory allegations of law and unwarranted inferences” will not defeat an otherwise proper 2 Rule 12(b)(6) motion. See Vasquez v. L.A. Cty., 487 F.3d 1246, 1249 (9th Cir. 2007) (internal 3 citation omitted). 4 The Court “ha[s] an obligation to give a liberal construction to the filings of pro se 5 litigants.” Blaisdell v. Frappiea, 729 F.3d 1237, 1241 (9th Cir. 2013). The Court will thus hold 6 Plaintiffs’ filings “to less stringent standards than normal pleadings drafted by lawyers.” Hughes 7 v. Rowe, 449 U.S. 5, 9 (1980) (internal quotation marks omitted). 8 B. Plaintiffs’ Failure-to-Warn Claims (Dkt. No. 10 at 7–8) 9 The Court cannot determine at this stage whether the warning provided by Defendant as 10 to the risk of cerebrovascular stroke was legally adequate. See Montalbano v. Ariad Pharm., Inc., 11 2015 WL 11198245, slip op. at 6 (S.D. Fla. 2015) (determining adequacy of the warning was not 12 well-advised at 12(b)(6) stage and better suited for summary judgement or trial); Webb v. Stryker 13 Corp., 2016 WL 11783344, slip op. at 3 (W.D. Pa. 2016) (plaintiffs need not allege, at the 14 pleadings stage, precisely how a warning was deficient or how an adequate warning would have 15 prevented injury). This is generally a question of fact for the jury and only becomes a question of 16 law where the warning is “accurate, clear, and unambiguous.” Ludy v. Eli Lilly and Company, 17 2020 WL 3510811 slip op. at 4 (S.D. Ind. 2020) (internal quotation marks omitted). In this case, 18 there is sufficient ambiguity in Cialis’s label and about whether a more specific stroke warning 19 was needed to prevent the Court from deciding the issue at the pleadings stage. 20 Plaintiffs’ claim, however, is still inadequately pled, as they fail to allege whether a 21 different label would have affected the prescribing physician’s decision to prescribe Cialis to Mr. 22 Dearinger. A failure to warn claim requires a plaintiff to show that (1) the defendant failed to 23 adequately warn, (2) the plaintiff suffered damages, and (3) the defendant’s failure to warn 24 proximately caused the plaintiff’s damages. Breen v. Ethicon, Inc., 2021 WL 673485 slip op. at 5 25 (W.D. Wash. 2021). But under the learned intermediary doctrine, a pharmaceutical manufacturer 26 satisfies its duty to warn the patient by properly warning the prescribing physician of the risks of 1 its product. Dearinger v. Eli Lilly & Co., 510 P.3d 326, 329 (Wash. 2022). The Washington State 2 Supreme Court confirmed that this principle applies even when a drug manufacturer advertises 3 its product directly to consumers. Id. at 331–33. Thus, to establish proximate cause, plaintiffs 4 must allege that a different warning would have impacted the physician’s decision to prescribe 5 this medication. See Tutwiler v. Sandoz, Inc., 726 F. App’x 753, 756 (11th Cir. 2018) (finding 6 allegations insufficient as plaintiff failed to allege that her physician would not have prescribed 7 the drug if he had been aware of the risks). 8 Even accepting Plaintiffs’ allegations that Cialis contained an inadequate warning about the 9 risk of suffering a particular type of stroke, they still have failed to allege that the prescribing 10 physician would have acted differently had Defendant provided an adequate warning. Id. The Court 11 believes that Plaintiffs can cure this defect by amending their complaint to properly allege proximate 12 cause of Mr. Dearinger’s injuries within the framework of the learned intermediary doctrine. 13 C. Preemption (Dkt. No. 14 at 10) 14 Defendant claims that Plaintiffs’ design defect claim is preempted because federal law 15 forbids Defendant from changing Cialis’s label design without prior FDA approval. (Dkt. No. 14 16 at 11).
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THE HONORABLE JOHN C. COUGHENOUR 1 2 3 4 5 6 UNITED STATES DISTRICT COURT 7 WESTERN DISTRICT OF WASHINGTON 8 AT SEATTLE 9 DAVID DEARINGER and GANNA CASE NO. C21-0060-JCC DEARINGER, 10 ORDER 11 Plaintiff, 12 v. 13 ELI LILLY AND COMPANY ,
14 Defendants. 15
17 This matter comes before the Court on Defendant Eli Lilly and Company’s motion to 18 dismiss for failure to state a claim (Dkt. No. 14). Having thoroughly considered the briefing and 19 the relevant record, the Court hereby GRANTS Defendant’s motion (Dkt. No. 14) and 20 DISMISSES Plaintiffs’ complaint without prejudice for the reasons explained below. 21 I. BACKGROUND 22 Plaintiffs allege that in 2018, Mr. Dearinger suffered an intracerebral hemorrhage leading 23 to a paralytic stroke within two hours of taking Cialis, a prescription drug that Defendant 24 manufactured and sold. (Dkt. No. 10 at 4.) Cialis is used to treat erectile dysfunction, enlarged 25 prostate symptoms, and pulmonary arterial hypertension. (Id.) Plaintiffs claim that, as a result of 26 this stroke, Mr. Dearinger suffered permanent loss of sensory and motor function of the left side 1 of his body. (Id.) They assert five causes of action under Washington’s Products Liability Act, 2 (Chapter 7.72 RCW): (1) design defect; (2) failure to warn at the time of manufacture; (3) failure 3 to warn after manufacturing; (4) breach of warranty; and (5) loss of consortium. (Dkt. No. 10 at 4 7–11.) Plaintiffs allege Defendant knew or should have known Cialis presented a risk of 5 paralytic stroke and failed to adequately warn of this risk. (Id. at 7–10.) Plaintiffs claim that 6 Cialis’s label does not adequately warn of the risk of cerebrovascular events because it warns of 7 the risk of stroke only in the context of “cardiovascular events.” (Dkt. No. 32 at 5.) 8 In April 2021, Defendant filed a motion to dismiss for failure to state a claim. (Dkt. No. 9 14 at 9). It argued, among other things, that under the learned intermediary doctrine, any duty to 10 warn was owed only to Mr. Dearinger’s prescribing physician, such that adequately pleading the 11 claim requires alleging that the doctor would have taken a “different course of action” had 12 Defendant provided a different warning. (Id.) Plaintiffs responded urging the Court to adopt an 13 exception to this doctrine for prescription drugs marketed directly to consumers, (Dkt. No. 25 at 14 12), and the Court certified the question to the Washington State Supreme Court. (Dkt. No. 28.) 15 The Supreme Court declined to recognize this exception and held that the learned intermediary 16 doctrine applies to prescription drugs marketed directly to consumers. (Dkt. No. 30-1 at 19.) The 17 parties then each submitted additional briefs (Dkt. Nos. 32, 34). 18 II. DISCUSSION 19 A. Legal Standard 20 To survive a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), “a 21 complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is 22 plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. 23 Twombly, 550 U.S. 544, 570 (2007)). A claim has facial plausibility when the plaintiff pleads 24 factual content that allows the court to draw the reasonable inference that the defendant is liable 25 for the misconduct alleged. Id. The Court accepts as true all material allegations of fact and 26 construes the complaint in a light “most favorable to the non-moving party,” however merely 1 “conclusory allegations of law and unwarranted inferences” will not defeat an otherwise proper 2 Rule 12(b)(6) motion. See Vasquez v. L.A. Cty., 487 F.3d 1246, 1249 (9th Cir. 2007) (internal 3 citation omitted). 4 The Court “ha[s] an obligation to give a liberal construction to the filings of pro se 5 litigants.” Blaisdell v. Frappiea, 729 F.3d 1237, 1241 (9th Cir. 2013). The Court will thus hold 6 Plaintiffs’ filings “to less stringent standards than normal pleadings drafted by lawyers.” Hughes 7 v. Rowe, 449 U.S. 5, 9 (1980) (internal quotation marks omitted). 8 B. Plaintiffs’ Failure-to-Warn Claims (Dkt. No. 10 at 7–8) 9 The Court cannot determine at this stage whether the warning provided by Defendant as 10 to the risk of cerebrovascular stroke was legally adequate. See Montalbano v. Ariad Pharm., Inc., 11 2015 WL 11198245, slip op. at 6 (S.D. Fla. 2015) (determining adequacy of the warning was not 12 well-advised at 12(b)(6) stage and better suited for summary judgement or trial); Webb v. Stryker 13 Corp., 2016 WL 11783344, slip op. at 3 (W.D. Pa. 2016) (plaintiffs need not allege, at the 14 pleadings stage, precisely how a warning was deficient or how an adequate warning would have 15 prevented injury). This is generally a question of fact for the jury and only becomes a question of 16 law where the warning is “accurate, clear, and unambiguous.” Ludy v. Eli Lilly and Company, 17 2020 WL 3510811 slip op. at 4 (S.D. Ind. 2020) (internal quotation marks omitted). In this case, 18 there is sufficient ambiguity in Cialis’s label and about whether a more specific stroke warning 19 was needed to prevent the Court from deciding the issue at the pleadings stage. 20 Plaintiffs’ claim, however, is still inadequately pled, as they fail to allege whether a 21 different label would have affected the prescribing physician’s decision to prescribe Cialis to Mr. 22 Dearinger. A failure to warn claim requires a plaintiff to show that (1) the defendant failed to 23 adequately warn, (2) the plaintiff suffered damages, and (3) the defendant’s failure to warn 24 proximately caused the plaintiff’s damages. Breen v. Ethicon, Inc., 2021 WL 673485 slip op. at 5 25 (W.D. Wash. 2021). But under the learned intermediary doctrine, a pharmaceutical manufacturer 26 satisfies its duty to warn the patient by properly warning the prescribing physician of the risks of 1 its product. Dearinger v. Eli Lilly & Co., 510 P.3d 326, 329 (Wash. 2022). The Washington State 2 Supreme Court confirmed that this principle applies even when a drug manufacturer advertises 3 its product directly to consumers. Id. at 331–33. Thus, to establish proximate cause, plaintiffs 4 must allege that a different warning would have impacted the physician’s decision to prescribe 5 this medication. See Tutwiler v. Sandoz, Inc., 726 F. App’x 753, 756 (11th Cir. 2018) (finding 6 allegations insufficient as plaintiff failed to allege that her physician would not have prescribed 7 the drug if he had been aware of the risks). 8 Even accepting Plaintiffs’ allegations that Cialis contained an inadequate warning about the 9 risk of suffering a particular type of stroke, they still have failed to allege that the prescribing 10 physician would have acted differently had Defendant provided an adequate warning. Id. The Court 11 believes that Plaintiffs can cure this defect by amending their complaint to properly allege proximate 12 cause of Mr. Dearinger’s injuries within the framework of the learned intermediary doctrine. 13 C. Preemption (Dkt. No. 14 at 10) 14 Defendant claims that Plaintiffs’ design defect claim is preempted because federal law 15 forbids Defendant from changing Cialis’s label design without prior FDA approval. (Dkt. No. 14 16 at 11). Manufacturers, however, can change their warning label without FDA approval by 17 proposing a “changes being effected” (“CBE”) labeling change, which underscores the “central 18 premise of federal drug regulation that a manufacturer bears responsibility for the content of its 19 label at all times.” Mason v. SmithKline Beecham Corp., 596 F.3d 387, 392 (7th Cir. 2010). 20 Defendant could raise an affirmative defense by showing “by clear evidence” that the FDA 21 would have rejected this label change. See id. at 396 (holding plaintiff’s claims were not 22 preempted where defendants failed to show by clear evidence the FDA would have rejected a 23 label warning change). But because such a claim requires evidence, it fails at the pleadings stage 24 and is more appropriate for summary judgment. 25 Moreover, the FDA’s statutory scheme governing approval for drugs does not evidence 26 congressional intent to insulate drug manufacturers from liability or otherwise alter state 1 products liability law. See Laisure-Radke v. Par Pharm., Inc., 2006 WL 901657 slip op. at 5–6 2 (W.D. Wash. 2006) (finding no conflict between state and federal laws); Wyeth v. Levine, 555 3 U.S. 555, 573 (2009) (ruling that defendant’s preemption claim was an “untenable interpretation 4 of congressional intent” and an “overbroad view” of agency’s power to preempt state law). 5 While it is true that generic drug manufacturers cannot unilaterally change their labels 6 (because they must match the brand-name labels), Cialis is the brand name of the generic drug 7 tadalafil, therefore this restriction does not apply to Defendant. (Dkt. No. 14 at 1); see also Mut. 8 Pharm. Co. v. Bartlett, 570 U.S. 472, 475–477 (“[F]ederal law prohibits generic drug 9 manufacturers from independently changing their drugs’ labels.”). Consistent with this, the Court 10 in PLIVA, Inc. v. Mensing, 564 U.S. 604, 616 (2011) explained that even generic drug makers 11 could propose warning label changes to the FDA if they thought it necessary, and the FDA 12 would “have worked with the brand-name manufacturer to create a new label for both the brand- 13 name and generic drug.”1 Indeed, the FDA requires that “labeling shall be revised to include a 14 warning as soon as there is reasonable evidence of an association of a serious hazard with a 15 drug.” 21 C.F.R. § 201.57(e). Therefore, Plaintiffs’ design defect claim is not preempted. 16 D. Plaintiffs’ Warranty Claim (Dkt. No. 10 at 10) 17 Defendant asserts that Plaintiffs’ warranty claim fails because there was no contractual 18 privity between the parties and Plaintiffs fail to allege any express representations were made to 19 sustain an express warranty claim. (Dkt. No. 14 at 14.) Plaintiffs’ opposition briefs do not 20 address their warranty claims at all. (See generally Dkt. Nos. 23, 25, 32.) 21 To establish a breach-of-warranty claim, the plaintiff must be in contractual privity with 22 the defendant. Baughn v. Honda Motor Co., Ltd., 727 P.2d 127, 151–152 (Wash. 1986). Here, 23 Plaintiffs fail to allege contractual privity with Defendant because they do not assert that they 24 purchased Cialis directly from Defendant. (See generally Dkt. No. 10.) The privity requirement 25
26 1 The Court nonetheless applied preemption in PLIVA for reasons that are not relevant here. 1 can be relaxed when a manufacturer makes express representations about the product. Baughn, 2 727 P.2d at 152. Under the learned intermediary doctrine, however, the express warranties run to 3 the physician rather than the plaintiff. Tapia v. Davol, Inc., 116 F.Supp.3d 1149, 1162 (S.D. Cal. 4 2015) (finding plaintiff failed to allege their prescribing physician read and relied on express 5 warranties made about the product). Therefore, Plaintiffs’ express warranty claim fails even in 6 the absence of the privity requirement as they fail to allege that Mr. Dearinger’s physician relied 7 on express representations about Cialis. (See generally Dkt. No. 10.) 8 E. Loss of Consortium 9 As Plaintiffs’ predicate causes of action are dismissed, their loss-of-consortium claim 10 also fails, as such claims cannot independently stand. See Carter v. Ethicon Inc., 2021 WL 11 1893749 slip op. at 3 (W.D. Wash. 2021) (dismissing loss-of-consortium claim because all of 12 plaintiff’s statutory claims were dismissed). 13 III. CONCLUSION 14 For the foregoing reasons, Defendant’s motion to dismiss (Dkt. No. 14) is GRANTED; 15 and Plaintiffs’ claim is DISMISSED without prejudice and with leave to amend. Plaintiffs shall 16 file an amended complaint addressing the deficiencies noted above within 30 days of this order. 17 Failure to do so may result in the dismissal being converted to a dismissal with prejudice, 18 without notice to Plaintiffs. 19 DATED this 30th day of June 2022. A 20 21 22 John C. Coughenour 23 UNITED STATES DISTRICT JUDGE 24 25 26