1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 JOSHUA ROSEWOLF, Case No. 22-cv-02072-JSW

8 Plaintiff,

ORDER GRANTING MOTION TO

9 v. DISMISS, WITH LEAVE TO AMEND

10 MERCK & CO., INC., et al., Re: Dkt. No. 18 Defendants. 11

12 13 Now before the Court for consideration is the motion to dismiss filed by Defendants Merck 14 & Co., Inc., Merck Sharp & Dohme Corp., Organon & Co., and Organon, LLC (“Defendants”). 15 The Court has considered the parties’ papers, relevant legal authority, and the record in this case, 16 and it HERREBY GRANTS Defendants’ motion. The Court will grant Rosewolf leave to amend. 17 BACKGROUND1 18 Defendants manufacture and sell the brand-name drug “Singulair” and held patent rights in 19 montelukast, Singulair’s active ingredient, until the patent expired in August 2012. (See, e.g., 20 Compl. ¶¶ 2, 28.) After the patent expired, other companies began to manufacture and sell generic 21 monteluskat. (Id. ¶ 87.) Plaintiff Joshua Rosewolf (“Rosewolf”) alleges that monteluskat can 22 cause neuropsychiatric injury by crossing the blood-brain-barriers. According to Rosewolf, 23 Defendants knew monteluskat could cause these types of injuries but failed to warn of those risks 24 and failed to maintain the accuracy and adequacy of Singulair’s warning label. (Id. ¶¶33-39, 46- 25

26 1 This is one of five cases pending before the undersigned. The other four cases are Starr v. Merck & Co., Inc., et al., No. 22-2138-JSW, Skinner v. Merck & Co., Inc., No. 2260-JSW, Gibson 27 v. Merck & Co., Inc., et al., No. 22-2263-JSW, and Anderson, et al., v. Merck & Co., Inc., No. 22- 2991-JSW. On August 9, 2022, the Court granted Defendants’ motion to sever and denied the 1 92.) Rosewolf also alleges that Defendants “engaged in an extensive campaign to educate 2 physicians in California about the alleged benefits of Singulair” but misrepresented its safety in 3 that campaign. (Id. ¶ 21.) 4 On March 4, 2020, the Food and Drug Administration (“FDA”) required Defendants to add 5 a Black Box Warning to Singulair’s label and required a new medication guide. That warning 6 stated: 7 Serious neuropsychiatric events have been reported in patients taking Singulair. These include: 8 agitation, aggressive behavior or hostility, anxiousness, depression, 9 disorientation, disturbance in attention, dream abnormalities, dysphagia (stuttering), hallucinations, insomnia, irritability, memory 10 impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior (including suicide), 11 tic, and tremor … 12 Psychiatric disorders: agitation including aggressive behavior or hostility, anxiousness, depressions, disorientation, dream 13 abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), 14 tremor [see Warnings and Precautions (5.4)]. 15 (Compl., ¶ 4 (emphasis in original)). 16 According to Rosewolf, the warning also states that “the benefits of Singulair may not 17 outweigh the risks,” and the FDA noted in a press release that “many patients and health care 18 professionals are not fully aware of these risks.” (Id.) Rosewolf alleges that if he or his physician 19 had known that Singulair “could cause [him] to suffer neuropsychiatric events, [the physician] 20 would not have prescribed Singulair,” and Rosewolf would not have ingested it. (Id. ¶ 11; see 21 also id. ¶ 86.) Rosewolf also alleges that: 22 Within the period of any applicable statute of limitations, [he] could not have discovered through the exercise of reasonable diligence 23 that Singulair caused a significantly increased risk of adverse neuropsychiatric events. 24 [He] did not discover, and did not know of, facts that would have 25 caused a reasonable person to suspect that his injuries were caused by Defendants’ concealment and suppression of the fact that 26 individuals who ingested Singulair were at significantly increased risk of developing neuropsychiatric events. 27 1 the FDA required the Boxed Warning about the serious mental health side effects for Singulair and the advisement on the restriction 2 of use of Singulair. 3 (Id. ¶¶ 94-96.) 4 The Court will address additional facts as necessary in the analysis. 5 ANALYSIS 6 A. Applicable Legal Standards. 7 When a defendant moves to dismiss for failure to state a claim under Federal Rule of Civil 8 Procedure 12(b)(6), the Court’s inquiry generally “is limited to the allegations in the complaint, 9 which are accepted as true and construed in the light most favorable to the plaintiff.” Lazy Y 10 Ranch Ltd. v. Behrens, 546 F.3d 580, 588 (9th Cir. 2008). Even under the liberal pleading 11 standard of Federal Rule of Civil Procedure 8(a)(2), “a plaintiff’s obligation to provide the 12 ‘grounds’ of his ‘entitle[ment] to relief’ requires more than labels and conclusions, and a 13 formulaic recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly, 14 550 U.S. 544, 555 (2007) (citing Papasan v. Allain, 478 U.S. 265, 286 (1986)). Pursuant to 15 Twombly, a plaintiff must not merely allege conduct that is conceivable but must instead allege 16 “enough facts to state a claim to relief that is plausible on its face.” Id. at 570. “A claim has facial 17 plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable 18 inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 19 678 (2009) (citing Twombly, 550 U.S. at 556). If the allegations are insufficient to state a claim, a 20 court should grant leave to amend, unless amendment would be futile. See, e.g., Reddy v. Litton 21 Indus., Inc., 912 F.2d 291, 296 (9th Cir. 1990); Cook, Perkiss & Liehe, Inc. v. N. Cal. Collection 22 Serv., Inc., 911 F.2d 242, 246-47 (9th Cir. 1990). 23 B. Rosewolf Fails Plead the Statute of Limitations Should be Tolled. 24 Defendants argue Rosewolf’s claims are barred by the statute of limitations and that he 25 fails to allege the limitations period should be tolled. “If the running of the statute is apparent on 26 the face of the complaint, the defense may be raised by a motion to dismiss.” Jablon v. Dean 27 Witter & Co., 614 F.2d 677, 682 (9th Cir. 1980). A court can grant a motion to dismiss on this 1 basis “only if the assertions of the complaint, read with the required liberality, would not permit 2 the plaintiff to prove that the statute was tolled.” Id. 3 Rosewolf alleges that he was prescribed and used Singulair from 2005 to 2008 and alleges 4 the drug caused him to suffer neuropsychiatric events including depression, hostility, suicidality, 5 and tics. (Id. ¶ 8.) California’s statute of limitations for personal injury claims is two years. Cal. 6 Code Civ. P. § 335.1. Under California law, “a cause of action accrues at ‘the time when the 7 cause of action is complete with all of its elements.’” Fox v. Ethicon Endo-Surgery, Inc., 35 Cal. 8 4th 797, 806 (2005) (quoting Norgart v. Upjohn Co., 21 Cal. 4th 383, 397, (1999)). Rosewolf 9 filed his complaint on March 4, 2022. 10 Rosewolf does not dispute that his claims would be barred unless the discovery rule 11 applies. That rule delays accrual of a claim until “a plaintiff discovers or has reason to discover a 12 cause of action,” i.e. when they have a “reason at least to suspect a factual basis for its elements.” 13 Id. at 807; see also Jolly v. Eli Lilly & Co., 44 Cal. 3d 1103, 1111 (1988) (a plaintiff will have 14 reason to know of a claim when they have “notice or information of circumstances to put a 15 reasonable person on inquiry”). In order to successfully plead tolling based on the discovery rule, 16 Rosewolf must allege facts that show (1) how and when he discovered facts supporting the claim 17 and (2) despite being reasonably diligent, he could not discover those facts earlier. Fox, 35 Cal. 18 4th at 808. 19 Rosewolf alleges that he was put on notice of his claims when the FDA issued the Black 20 Box warning on March 4, 2020, but he does not allege that he actually saw the warning on that 21 date. Rosewolf stopped taking Singulair in 2008. If that was the date his claims accrued, the 22 claims would be timely. However, there is a twelve year gap between the date Rosewolf stopped 23 taking Singulair and the Black Box warning, and Rosewolf alleges he developed symptoms while 24 taking the drug. Rosewolf includes no facts about when he actually learned of the warning or 25 what he may have done prior to that date to investigate his symptoms. See, e.g., Darringer v. 26 Intuitive Surgical, Inc., No. 15-cv-00300-RMW, 2015 WL 6735333, at *2 (N.D. Cal. Nov. 4, 27 2015) (plaintiff satisfied burden to plead time and manner of discovery where plaintiff alleged he 1 he saw an online article). 2 Rosewolf relies, in part, on Martin v. Medtronic, Inc, No. 15-cv-00994-DAD-MJS, 2017 3 WL 825410, at *14 (E.D. Cal. Feb. 24, 2017) (citing Retger v. Stryker Corp., 607 Fed. Appx. 732, 4 733 (9th Cir. 2015)). In that case, the plaintiff alleged he was injured by defendant’s medical 5 device. He alleged he received medical treatment for those injuries and alleged he relied on his 6 doctor to inform him of the cause of the injury. The court concluded those allegations were 7 sufficient to plead reasonable diligence. Id. Rosewolf argues that, like the plaintiff in Martin, he 8 relied on his doctor to inform him of the causes of the symptoms he experienced and argues that 9 neither he nor his physician were aware of the dangers Singulair posed. The Court does not find 10 Rosewolf’s reliance on Martin persuasive. Rosewolf not allege whether he discussed the 11 symptoms with his physician. Although he does allege that his physician was not aware of the 12 dangers Singulair allegedly posed, he does not allege that he depended on his physician to “inform 13 him of the cause of the injury.” Martin, 2017 WL 825410, at *14. The Court finds Rosewolf’s 14 reliance on Eidson v. Medtronic, Inc., unpersuasive for similar reasons. 40 F. Supp. 3d 1202 15 (N.D. Cal. 2014). In that case, the court found the plaintiffs’ allegations in an amended complaint 16 were sufficient to allege tolling where they alleged their doctor did not inform them that the 17 defective product was used during plaintiff’s surgery and where the doctor later ascribed post- 18 operative pain to a biological phenomenon. Id. at 1222. 19 Finally, a plaintiff is “charged with presumptive knowledge of an injury if they have 20 information of circumstances to put [them] on inquiry or if they have the opportunity to obtain 21 knowledge from sources open to [their] supervision.” Fox, 35 Cal. 4th at 807-08 (internal 22 quotation marks omitted). Rosewolf includes information about Singulair’s earlier warning labels 23 and also describes studies regarding the potential for neuropsychiatric events. Rosewolf fails to 24 allege facts to show why that information would not have put him on inquiry notice of his claim. 25 Accordingly, the Court concludes that Rosewolf’s allegations are insufficient to plead 26 around the statute of limitations, and it GRANTS Defendants’ motion to dismiss. Because the 27 Court cannot say it would be futile, it will grant Rosewolf leave to amend. 1 CONCLUSION 2 For the foregoing reasons, the Court GRANTS Defendants’ motion to dismiss and 3 GRANTS Rosewolf leave to amend. Defendants raised arguments about the merits of Rosewolf’s 4 || claims that are nearly identical to arguments raised in motions to dismiss filed in the related cases. 5 The Court will issue a separate order resolving those motions. Rosewolf may file an amended 6 || complaint within 21 days from the date the Court issues that Order, and Defendants shall answer 7 || or otherwise respond to an amended complaint within the time allowed under the Federal Rules of 8 Civil Procedure. 9 IT ISSO ORDERED. a, 10 || Dated: August 16, 2022 / | / Nts \ LAs

JEFFREY, S{ WHIT

12 United Yates Disty/t Judge /

16

Oo

Z 18

19 20 21 22 23 24 25 26 27 28