Dearinger v. Eli Lilly and Company

Opinion

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 Plaintiffs, 12 v. 13 ELI LILLY AND COMPANY ,

14 Defendant. 15

17 This matter comes before the Court on Plaintiffs’ motion to amend their complaint (Dkt. 18 No. 65), Defendant’s motion for summary judgment (Dkt. No. 59), and Defendant’s motion to 19 seal (Dkt. No. 73). Having thoroughly considered the briefing and the relevant record, and 20 finding oral argument unnecessary, the Court hereby DENIES the motion to amend (Dkt. No. 21 65), GRANTS in part and DENIES in part the motion for summary judgment (Dkt. No 59), and 22 GRANTS the motion to seal (Dkt. No. 73) for the reasons explained below. 23 I. BACKGROUND 24 Plaintiffs allege in a Second Amended Complaint (“SAC”) (Dkt. No. 37) that in 2018 25 Plaintiff David Dearinger suffered an intracranial brain hemorrhage, i.e., a stroke, resulting in the 26 permanent loss of “sensory and motor function of the left side of his body.” (Id. at 2–3.) The 1 SAC contends that Defendant’s prescription erectile dysfunction drug Cialis was the cause.1 (Id.) 2 Accordingly, it asserts Washington’s Product Liability Act (“WPLA”) claims, along with 3 fraudulent concealment and loss of consortium. (See generally id.) The SAC is the result of a 4 long and winding road. 5 Plaintiffs brought the case in early 2021. At the time, they sought to file their complaint 6 in forma pauperis (“IFP”). (See Dkt. No. 1.) The proposed complaint alleged Mr. Dearinger’s 7 stroke was, in fact, caused by Cialis and that Defendant failed to adequately warn Mr. Dearinger 8 of this risk. (See generally Dkt. No. 1.) The associated claims were for negligence and loss of 9 consortium. (Id.) The Court granted their IFP application, (Dkt. No. 4), but it declined to issue 10 summons and dismissed the complaint without prejudice for failure to state a claim. (See Dkt. 11 No. 9 at 1–2.) At the same time, the Court provided Plaintiffs leave to amend, suggesting they 12 replead their allegations, but in support of a WPLA action. (Id.)2 13 Shortly thereafter, Plaintiffs filed their First Amended Complaint (“FAC”) (Dkt. No. 10). 14 It contained similar factual allegations as the last, but sought WPLA relief, along with a claim for 15 loss of consortium. (See id. at 7–12.) On this basis, the Court issued summons. (See Dkt. No. 11.) 16 Defendant then moved to dismiss. (See generally Dkt. No. 14.) It argued, in part, that Plaintiffs’ 17 failure to warn claim(s) failed as a matter of law, based on the learned intermediary doctrine. 18 (See id. at 5–14.)3 In response, Plaintiffs argued the doctrine should be modified for prescription 19

20 1 In a prior complaint, Plaintiffs alleged that the hemorrhage was, in fact, caused by Mr. Dearinger’s ingestion of Cialis. (See Dkt. No. 10 at 4.) Whereas the SAC does not contain this 21 explicit allegation. (See generally Dkt. No. 37.) Instead, it frames the issue primarily as one of 22 proximate cause. (See, e.g., id. at 10–16.) Nevertheless, based on the allegations and legal conclusions contained throughout the SAC, the Court infers Plaintiffs maintain their contention 23 that Mr. Dearinger’s hemorrhage was, in fact, caused by Cialis. See Blaisdell v. Frappiea, 729 F.3d 1237, 1241 (9th Cir. 2013) (discussing the Court’s “obligation to give a liberal construction 24 to the filings of pro se litigants.”). 2 The Court provided Plaintiffs this solicitude in light of their pro se status. See Hughes v. 25 Rowe, 449 U.S. 5, 9 (1980). 26 3 According to the doctrine, so long as a prescription drug maker adequately warned a prescribing physician of the drug’s risks, it had no duty to directly warn the patient, reserving 1 drugs, like Cialis, if producers directly market them to consumers. (See Dkt. No. 20.) Lacking 2 controlling authority for this proposition, Plaintiffs asked the Court to certify the question to the 3 Washington Supreme Court. (Id.) The Court did just that and stayed consideration of 4 Defendant’s motion. (See Dkt. No. 28.) 5 In a June 2022 unanimous decision, the Washington Supreme Court confirmed that 6 prescription medication marketed directly to consumers remained subject to the learned 7 intermediary doctrine. Dearinger v. Eli Lilly and Co., 510 P.3d 326, 335 (Wash. 2022). 8 According to that court, this is because all prescription drugs (regardless of how they are 9 marketed) are complex and carry significant risks. Id. at 334. Only a prescribing physician can 10 give “tailored warnings to patients . . . based on that patient’s medical history and needs.” Id. 11 Following this decision, this Court lifted the stay on Defendant’s motion to dismiss, and 12 then granted the motion. (See Dkt. No. 35 at 3–4.) It did so because the FAC failed to allege that 13 Mr. Dearinger’s prescribing physician would have acted differently if Cialis contained a different 14 warning regarding the risk of stroke. (See generally Dkt. No. 10.) Nevertheless, the Court again 15 granted Plaintiffs leave to amend, providing them yet another opportunity to adequately plead 16 their claims before the case would proceed to discovery. (Dkt. No. 35 at 6.) 17 In July 2022 Plaintiffs then filed the SAC (Dkt. No. 37). This time, they alleged that “[a]n 18 adequate warning of the risk of [stroke resulting from an intracranial hemorrhage] would have 19 altered the prescribing physician’s decision to prescribe Cialis.” (Dkt. No. 37 at 12–15.) With 20 this allegation, a key component of their legal theory, a failure to warn, was now adequately 21 pleaded, and the Court allowed the case to proceed to discovery. (See Dkt. No. 48.) 22 With discovery ongoing,4 Defendant now moves for summary judgment. (See Dkt. No. 23 59 at 15–24.) Plaintiffs oppose, (see Dkt. No. 67), and separately ask for leave to amend, (see 24 generally Dkt. No. 65; see also Dkt. No. 65-1 at 2 (proposed Third Amended Complaint)).

25 this duty to the “learned intermediary.” See Taylor v. Intuitive Surgical, Inc., 389 P.3d 517, 524 26 (Wash. 2017). 4 The cut-off date is February 2, 2024. (See Dkt. No. 48.) 1 II. DISCUSSION 2 A. Motion to Amend 3 A court should “freely give leave to amend when justice so requires.” Fed. R. Civ. P. 4 15(a)(2). In determining whether to do so, the Court considers “the presence or absence of undue 5 delay, bad faith, dilatory motive, repeated failure to cure deficiencies . . . , undue prejudice to the 6 opposing party[,] and futility of the proposed amendment.” Kroessler v. CVS Health Corp., 977 7 F.3d 803, 814–15 (9th Cir. 2020). 8 Defendant argues the proposed amendment is prejudicial and untimely. (See Dkt. No. 71 9 at 8, 14.) As to prejudice, Defendant relies on a need for additional discovery. (Dkt. No. 71 at 8– 10 10.) Indeed, this can support a prejudice finding. See AmerisourceBergen Corp. v. Dialysist 11 West, Inc., 465 F.3d 946, 960 (9th Cir. 2006). But only if compelling reasons counsel against 12 extending the discovery cut-off and/or trial date(s). And Defendant fails to explain how or why 13 that is so here. (See generally Dkt. No. 71.) As to timeliness, Plaintiffs make vague references to 14 newly obtained information, and assert they could not have discovered it earlier. (See generally 15 Dkt. No. 65.) But their briefing lacks the specificity necessary to support their request for leave 16 to amend. See AmerisourceBergen Corp, 464 F.3d at 953. Nevertheless, “delay alone . . . is an 17 insufficient ground for denial of leave to amend. U.S. v. Webb, 655 F.2d 977, 980 (9th Cir. 18 1981). So these factors, on a combined basis, appear neutral. 19 But given the futility of Plaintiffs’ proposed amendment, the Court declines Plaintiffs’ 20 request. See Sweaney v. Ada County, 119 F.3d 1385, 1393 (9th Cir. 1997). This is because the 21 newly proposed claim(s) fail to relate back to those alleged in the original complaint, and without 22 benefit of this provision, the proposed additional claim(s) are now time-barred. (See Dkt. No. 71 23 at 11.) 24 A pleading amendment relates back to the date of the original pleading when it “asserts a 25 claim or defense that arose out of the conduct, transaction, or occurrence set out—or attempted 26 to be set out—in the original pleading.” Fed. R. Civ. P. 15(c)(1)(B). “Claims arise out of the 1 same conduct, transaction, or occurrence if they share a common core of operative facts such that 2 the plaintiff will rely on the same evidence to prove each claim.” Williams v. Boeing Co., 517 3 F.3d 1120, 1133 (9th Cir. 2008). When a plaintiff seeks to amend a complaint to state a new 4 claim against a defendant, “the court compares the original complaint with the amended 5 complaint and decides whether the claim to be added will likely be proved by the ‘same kind of 6 evidence’ offered in support of the original pleading.” Percy v. S.F. General Hosp., 841 F.2d 7 975, 978 (9th Cir. 1988). 8 Plaintiff’s proposed amendment relates to a July 2017 retinal detachment. Other than the 9 alleged cause in fact—Mr. Dearinger’s use of Cialis—this allegation shares no common core of 10 facts with the 2018 stroke included in the SAC. (Compare Dkt. No. 65-1 at 14–17, with Dkt. No. 11 37 at 11–15.) Nor are they temporally related. Therefore, there is no basis to relate back the 12 newly proposed claim(s) to the existing ones. And without an application of these rules, 13 Plaintiff’s new claims are time-barred. Any injury associated with the alleged retinal detachment 14 occurred more than six years ago. (See Dkt. No. 65-1 at 14–17.) Yet the statute of limitations for 15 WPLA claims is three years. RCW 7.72.060(3). This period began to run when Plaintiffs, 16 through the “exercise of due diligence should have discovered the harm and its cause.” Id. While 17 Plaintiffs now contend that they only recently discovered the connection between the Mr. 18 Dearinger’s use of Cialis and his risk of retinal detachment, they fail to describe, with any 19 specificity, why. (See generally Dkt. Nos. 65, 77, 82.)5 20 Accordingly, the Court DENIES Plaintiffs’ motion for leave to amend (Dkt. No. 65). 21 B. Motion for Summary Judgment 22 Defendant seeks summary judgment on all claims, arguing that, without any evidence 23 supporting proximate cause, Plaintiffs cannot support their WPLA claims, and the remaining 24 claims fail as a matter of law. (See Dkt. No. 59 at 10–24.) “The court shall grant summary 25

26 5 Defendant asks to strike the last submission (Dkt. No. 82) as untimely. (See Dkt. No. 83.) Because it ultimately is of no help to Plaintiffs, the Court declines that request. 1 judgment if the movant shows that there is no genuine dispute as to any material fact and the 2 movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). In making such a 3 determination, the Court must view the facts in the light most favorable to the nonmoving party 4 and draw justifiable inferences in that party’s favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 5 242, 255 (1986). Ultimately, summary judgment is appropriate against a party who “fails to 6 make a showing sufficient to establish the existence of an element essential to that party’s case, 7 and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477 U.S. 8 317, 322 (1986). 9 In moving for summary judgment on Counts 1–3 of the SAC, Defendant relies primarily 10 on testimony from two key individuals: Mr. Dearinger and Earl Bardin, M.D. (Dkt. No. 59.) 11 According to Mr. Dearinger, the Cialis dose at issue was, in fact, prescribed by Dr. Bardin. (Dkt. 12 No. 60-5 at 6–7, 60-7 at 8.) And Dr. Bardin testified that (a) he was aware of Cialis’s risk of 13 hemorrhagic strokes and (b) even if he had received a stronger warning of the risk(s), such as the 14 one which Plaintiffs later suggest is adequate, Dr. Bardin would not have “changed [his] 15 decision to prescribe Cialis [to Mr. Dearinger].” (Dkt. Nos. 60-1 at 17, 26, 27; 60-7 at 15.) 16 Plaintiffs fail to provide any evidence rebutting this testimony. (See generally Dkt. No. 17 67.) Instead, they cast aspersions on Dr. Bardin’s judgment and professional competence. (See 18 id. at 9–11.) This is irrelevant to the case at hand, which is against Eli Lilly, not Dr. Bardin. 19 Moreover, it is woefully inadequate to defeat a motion for summary judgment. In addition, the 20 Court notes with some concern that this testimony directly contradicts the SAC’s allegations. 21 (See Dkt. No. 37 at 12–14.) 22 At least as it relates to claims involving a failure to warn of the risks of stroke, i.e., 23 Counts 2 and 3 of the SAC, the Court finds that Plaintiffs fail to establish a genuine issue of fact 24 on the issue of proximate cause. See Celotex Corp., 477 U.S. at 322; see also RCW 25 7.72.030(1)(b), (c) (describing a lack of “adequate warnings”). And without this, Plaintiffs 26 cannot proceed to trial on these claims. Accordingly, summary judgment is GRANTED to 1 Defendant on Counts 2 and 3 of the SAC. (See Dkt. No. 37 at 11–13 (citing RCW 2 7.72.030(1)(b), (c)).) 3 However, summary judgment is DENIED on Count 1, as that count is based on the 4 WPLA’s design defect provision(s), rather than a failure to warn. (See id. at 10–11 (citing RCW 5 7.72.030(1)(a), (3)).) And Defendant fails to meaningfully address this count in its motion. (See 6 generally Dkt. No. 59.) Perhaps the same infirmity as to Counts 2 and 3 would apply to Count 1. 7 But, if so, Defendant fails to indicate how. And the Court will not make Defendant’s argument 8 for it. See Coto Settlement v. Eisenberg, 593 F.3d 1031 (9th Cir. 2010). 9 Defendant also seeks summary judgment on Count 4, (Dkt. No 37 at 13–14), which 10 asserts a claim for fraudulent concealment. (See Dkt. No. 59 at 21–22.) Defendant contends the 11 claim fails as a matter of law for a number of reasons, including that it is barred by the WPLA. 12 (Id. at 21–22.) The Court agrees. “The WPLA is the exclusive remedy [under Washington law] 13 for product liability claims, including claims for inadequate warnings.” Taylor v. Intuitive 14 Surgical, Inc., 389 P.3d 517, 523 (Wash. 2017). It supplants “all common law claims or actions 15 based on harm caused by a product.” Macias v. Saberhagen Holdings, Inc., 282 P.3d 1069, 1073 16 (Wash. 2012). Accordingly summary judgment on Count 4 is GRANTED to Defendant. 17 In addition, Defendant seeks summary judgment on Count 5, (Dkt. No 37 at 16), which 18 asserts a claim for loss of consortium. (See Dkt. No. 59 at 23.) But Defendant relies solely on its 19 expectation that all predicate causes of action, i.e., Counts 1–4 will be dismissed. (Id.) And for 20 the reasons described above, Count 1 remains. So this argument is defective. Defendant provides 21 the Court with no other basis supporting summary judgment on Count 5. Perhaps there is a 22 separate basis to dismiss this claim. But again, the Court will not make Defendant’s argument for 23 it. Accordingly, summary judgment is DENIED on Count 5. 24 C. Motion to Seal 25 Finally, Defendant moves to maintain under seal an exhibit containing medical and 26 business records. (Dkt. No. 73.) While the public has a common law right to inspect and copy 1 public records, including those from judicial proceedings, these rights are not absolute. They 2 must yield when (1) sealing a document serves a compelling interest, (2) that is substantially 3 likely to be harmed if the document is not sealed, and (3) there are no less restrictive alternatives 4 for protecting the interest. See United States v. Doe, 870 F.3d 991, 998 (9th Cir. 2017). Given the 5 nature of the information contained in the exhibits, these criteria are met here. Accordingly, 6 Defendant’s motion to seal (Dkt. No. 73) is GRANTED. 7 III. CONCLUSION 8 For the foregoing reasons, the Court DENIES Plaintiffs’ motion to amend (Dkt. No. 65), 9 GRANTS in part and DENIES in part Defendant’s motion for summary judgment (Dkt. No 59), 10 and GRANTS Defendant’s motion to seal (Dkt. No. 73) and ORDERS that Counts 2, 3, and 4 of 11 the SAC be DISMISSED with prejudice. 12 13 DATED this 18th day of December 2023. A 14 15 16 John C. Coughenour 17 UNITED STATES DISTRICT JUDGE 18 19 20 21 22 23 24 25 26