Anderson v. Merck & Co., Inc. ( 2022 )

1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 AMY ANDERSON, Case No. 22-cv-02991-JSW 8 Plaintiff, ORDER GRANTING, IN PART, AND 9 v. DENYING, IN PART, MOTION TO DISMISS, WITH LEAVE TO AMEND 10 MERCK & CO., INC., et al., Re: Dkt. No. 17 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 For the reasons that follow, the Court GRANTS, IN PART, AND DENIES, IN PART, the motion. 17 BACKGROUND 18 A. Preliminary Matters. 19 This is one of nine related cases pending before the Court that assert similar claims against 20 Defendants. On October 12, 2022, the Court denied, in part, motions to dismiss filed in several of 21 those cases and concluded it had specific jurisdiction over Defendants. See Rosewolf v. Merck & 22 Co., Inc., No. 22-cv-02072-JSW, 2022 WL 7127953 (N.D. Cal. Oct. 12, 2022) (“Rosewolf II”). 23 Defendants state they move pursuant to Federal Rule of Civil Procedure 12(b)(2) to preserve their 24 argument that the Court lacks personal jurisdiction over them but did not repeat their argument 25 from earlier briefs. There are no material differences between the facts in this case and the facts in 26 Rosewolf II, and for the reasons cited therein, the Court DENIES Defendants’ motion to dismiss 27 for lack of personal jurisdiction. 2022 WL 7127953, at *2-5. 1 In her opposition, Plaintiff Amy Anderson (“Anderson”) conceded that her first claim for 2 relief (strict liability – design defect) should be dismissed. She also conceded that her negligence 3 claim should be dismissed, in part, to the extent it is premised on a manufacturing defect. (Opp. 4 Br. at 5:26-6:3.) Pursuant to Anderson’s voluntary dismissal, those claims are dismissed. 5 B. Factual Background. 6 Defendants manufacture and sell the brand-name drug “Singulair” and held patent rights in 7 montelukast, Singulair’s active ingredient, until the patent expired in August 2012. (Dkt. No. 1-1, 8 Declaration of Julia Romano, ¶ 3 Ex. 1, Compl. ¶¶ 2, 29.) After the patent expired, other 9 companies began to manufacture and sell generic monteluskat. (Id. ¶ 88.) Anderson alleges that 10 monteluskat can cause neuropsychiatric injury by crossing the blood-brain-barriers. According to 11 Anderson, Defendants knew monteluskat could cause these types of injuries but failed to warn of 12 those risks and failed to maintain the accuracy and adequacy of Singulair’s warning label. (Id. ¶¶ 13 34-87.) Anderson also alleges that Defendants “engaged in an extensive campaign to educate 14 physicians in California about the alleged benefits of Singulair” but misrepresented its safety in 15 that campaign. (Id. ¶ 21.) 16 On March 4, 2020, the Food and Drug Administration (“FDA”) required Defendants to add 17 a Black Box Warning to Singulair’s label and required a new medication guide. That warning 18 stated: 19 Serious neuropsychiatric events have been reported in patients taking Singulair. These include: 20 agitation, aggressive behavior or hostility, anxiousness, depression, 21 disorientation, disturbance in attention, dream abnormalities, dysphagia (stuttering), hallucinations, insomnia, irritability, memory 22 impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior (including suicide), 23 tic, and tremor … 24 Psychiatric disorders: agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, dream 25 abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), 26 tremor [see Warnings and Precautions (5.4)]. 27 (Compl., ¶ 4 (emphasis in original)). 1 FDA noted in a press release that “many patients and health care professionals are not fully aware 2 of these risks.” (Id., ¶¶ 4, 6.) Anderson alleges that if she or her physician had known that 3 Singulair “could cause [her] to suffer neuropsychiatric events, [the physician] would not have 4 prescribed Singulair,” and she would not have ingested it. (Id. ¶¶ 8, 12, 87.) 5 Anderson also alleges that: 6 [w]ithin the period of any applicable statute of limitations, [she] could not have discovered through the exercise of reasonable 7 diligence that Singulair caused a significantly increased risk of adverse neuropsychiatric events. 8 [She] did not discover, and did not know of, facts that would have 9 caused a reasonable person to suspect that [her] injuries were caused by Defendants’ concealment and suppression of the fact that 10 individuals who ingested Singulair were at significantly increased risk of developing neuropsychiatric events. 11 [She] could not have reasonably discovered the true extent of 12 Defendants’ deception or suppression about Singulair’s safety until the FDA required the Boxed Warning about the serious mental 13 health side effects for Singulair and the advisement on the restriction of use of Singulair. 14 15 (Id. ¶¶ 95-96.) 16 Based on these and other allegations that the Court will address as necessary, Anderson 17 asserts claims for: (1) strict liability – failure to warn; (2) negligence; (3) negligent 18 misrepresentation; (4) breach of express warranty; and (5) breach of implied warranty. 19 ANALYSIS 20 A. Applicable Legal Standards. 21 When a defendant moves to dismiss for failure to state a claim under Federal Rule of Civil 22 Procedure 12(b)(6), the Court’s inquiry generally “is limited to the allegations in the complaint, 23 which are accepted as true and construed in the light most favorable to the plaintiff.” Lazy Y 24 Ranch Ltd. v. Behrens, 546 F.3d 580, 588 (9th Cir. 2008). Even under the liberal pleading 25 standard of Federal Rule of Civil Procedure 8(a)(2), “a plaintiff’s obligation to provide the 26 ‘grounds’ of his ‘entitle[ment] to relief’ requires more than labels and conclusions, and a 27 formulaic recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly, 1 Pursuant to Twombly, a plaintiff must not merely allege conduct that is conceivable but 2 must instead allege “enough facts to state a claim to relief that is plausible on its face.” Id. at 570. 3 “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to 4 draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. 5 Iqbal, 556 U.S. 662, 678 (2009) (citing Twombly, 550 U.S. at 556). 6 If the allegations are insufficient to state a claim, a court should grant leave to amend, 7 unless amendment would be futile. See, e.g., Reddy v. Litton Indus., Inc., 912 F.2d 291, 296 (9th 8 Cir. 1990); Cook, Perkiss & Liehe, Inc. v. N. Cal. Collection Serv., Inc., 911 F.2d 242, 246-47 (9th 9 Cir. 1990). 10 B. Anderson Fails to Plead the Statute of Limitations Should be Tolled. 11 Defendants argue Anderson’s claims are barred by the statute of limitations and that she 12 fails to allege the limitations period should be tolled. “If the running of the statute is apparent on 13 the face of the complaint, the defense may be raised by a motion to dismiss.” Jablon v. Dean 14 Witter & Co., 614 F.2d 677, 682 (9th Cir. 1980). A court can grant a motion to dismiss on this 15 basis “only if the assertions of the complaint, read with the required liberality, would not permit 16 the plaintiff to prove that the statute was tolled.” Id. 17 Defendants raised the same argument with respect to Plaintiff Rosewolf, and the Court 18 granted Defendants’ motion, with leave to amend. Rosewolf v. Merck & Co., Inc., No. 22-cv- 19 2072-JSW, 2022 WL 3372101, at *3-4 (N.D. Cal. Aug. 16, 2022) (“Rosewolf I”). Anderson 20 alleges that she was prescribed Singulair between 2000 and 2020, and that “many or all” of her 21 prescriptions were filled with branded Singulair, although she acknowledges some prescriptions 22 may have been filed with generic Singulair. She also alleges the drug caused her to suffer 23 neuropsychiatric events including depression, anxiety, panic disorder, stuttering, tics, and self- 24 harm. (Compl. ¶ 8.) “[A] cause of action accrues at ‘the time when the cause of action is 25 complete with all of its elements.’” Fox v. Ethicon Endo-Surgery, Inc., 35 Cal. 4th 797, 806 26 (2005) (quoting Norgart v. Upjohn Co., 21 Cal. 4th 383, 397, (1999)). Anderson originally filed 27 her complaint with two other named plaintiffs on March 4, 2022. 1 would be applicable to her claims and does not dispute that her claims would be barred unless the 2 discovery rule applies. That rule delays accrual of a claim until “a plaintiff discovers or has reason 3 to discover a cause of action,” i.e. when they have a “reason at least to suspect a factual basis for 4 its elements.” Id. at 807; see also Jolly v. Eli Lilly & Co., 44 Cal. 3d 1103, 1111 (1988) (a 5 plaintiff will have reason to know of a claim when they have “notice or information of 6 circumstances to put a reasonable person on inquiry”). In order to successfully plead tolling based 7 on the discovery rule, Anderson must allege facts that show (1) how and when she discovered 8 facts supporting the claim and (2) despite being reasonably diligent, she could not discover those 9 facts earlier. Fox, 35 Cal. 4th at 808. 10 Anderson acknowledges that Singulair’s label included warnings about neuropsychiatric 11 events before 2020, although she alleges the warnings should have been stronger. (See, e.g., 12 Compl. ¶¶ 56, 61, 63, 66-67, 71-73.) Anderson alleges that she was put on notice of her claims 13 only when the FDA issued the Black Box warning on March 3, 2020. (Id. ¶ 97.) If that is the date 14 her claims actually accrued, her claims would be timely. Anderson alleges she took Singulair – or 15 its generic equivalent – until 2020, which distinguishes the facts here from the facts in Rosewolf I, 16 where there was a twelve year gap between the date the plaintiff last used the drug and the date the 17 Black Box warning was issued. However, like the plaintiff in Rosewolf I, Anderson alleges she 18 became symptomatic while ingesting Singulair. 19 Although Anderson provides no details about when her symptoms began, Defendants 20 argue that because she uses the “®” mark following Singulair, she must have become 21 symptomatic at some point between 2000 and 2012, when the only form of Singulair available 22 was the branded version of the drug. The Court concludes it is reasonable to infer that Anderson’s 23 claims accrued at some point prior to March 4, 2020, a conclusion supported by the fact that 24 Anderson expressly alleges the statute of limitations should be tolled. 25 Like the plaintiff in Rosewolf I, Anderson includes no facts to show when or how she 26 learned about the Black Box label. She also not include any factual allegations about what she did 27 prior to March 3, 2020 to investigate her symptoms. See, e.g., Rosewolf I, 2022 WL *3 (citing 1 Nov. 4, 2015)). Anderson relies, in part, on Martin v. Medtronic, Inc, No. 15-cv-00994-DAD- 2 MJS, 2017 WL 825410, at *14 (E.D. Cal. Feb. 24, 2017) (citing Retger v. Stryker Corp., 607 Fed. 3 Appx. 732, 733 (9th Cir. 2015)). In that case, the plaintiff alleged he was injured by defendant’s 4 medical device. The plaintiff also alleged he received medical treatment for those injuries and 5 alleged he relied on his doctor to inform him of the cause of the injury. The court concluded those 6 allegations were sufficient to plead reasonable diligence. Id. Anderson argues that, like the 7 plaintiff in Martin, she relied on her doctor to inform her of the causes of the symptoms he 8 experienced and argues that neither she nor her physician were aware of the dangers Singulair 9 posed. 10 With the exception of the year she stopped taking Singulair, Anderson’s allegations are 11 identical to the allegations in Rosewolf I. For the reasons articulated in that opinion, the Court 12 finds Anderson’s reliance on Martin and Eidson v. Medtronic, Inc. 40 F. Supp. 3d 1202 (N.D. Cal. 13 2014) unpersuasive. Rosewolf I, 2022 WL 3372101, at *3. Finally, “a plaintiff is ‘charged with 14 presumptive knowledge of an injury if they have information of circumstances to put [them] on 15 inquiry or if they have the opportunity to obtain knowledge from sources open to [their] 16 supervision.’” Id. (quoting Fox, 35 Cal. 4th at 807-08 (internal quotation marks omitted)). 17 Anderson includes information about Singulair’s earlier warning labels and also describes studies 18 regarding the potential for neuropsychiatric events. Like Rosewolf, she fails to allege why that 19 information would not have put her on inquiry notice of her claim. That is, she fails to provide 20 facts to support her assertion that despite being reasonably diligent, she could not have discovered 21 the facts giving rise to her claims earlier. Fox, 35 Cal. 4th at 808. 22 Accordingly, the Court concludes that Anderson’s allegations are insufficient to plead 23 around the statute of limitations, and it GRANTS Defendants’ motion to dismiss. 24 C. The Court Cannot Conclude On this Record That Anderson’s Negligence Claim Is Preempted. 25 26 Defendants also argue that Anderson’s negligence claim is preempted. In light of the other 27 pending cases and in order to evaluate whether it would be futile to grant Anderson leave to 1 amend, the Court addresses this argument.1 The Supremacy Clause provides that federal law is 2 “the supreme Law of the Land ..., any Thing in the Constitution or Laws of any State to the 3 Contrary notwithstanding.” U.S. Const. art. VI cl. 2. Therefore, “state laws that conflict with 4 federal law are without effect.” Mut. Pharm. Co., Inc. v. Bartlett, 570 U.S. 472, 479-80 (2013) 5 (internal quotation and citation omitted) (“Bartlett”); see also PLIVA, Inc. v. Mensing, 564 U.S. 6 604, 617 (2011) (“[W]here state and federal law directly conflict, state law must give way.”) 7 (“Mensing”). Defendants argue it is impossible for them to comply with “both state and federal 8 law requirements.” Id. The Supreme Court has addressed the “demanding defense” of 9 impossibility preemption in the context of prescription drugs in a trio of cases beginning with 10 Wyeth v. Levine, 555 U.S. 555, 573 (2009). 11 In Wyeth, the Court held that a state law failure-to-warn claim against the manufacturer of 12 a brand-name drug was not preempted because the defendant could modify its labelling without 13 FDA approval. 555 U.S. at 568. The Court addressed the possibility that the FDA could have 14 rejected a proposed change. It concluded, however, that it was not impossible for the defendant to 15 comply with federal and state law “absent clear evidence that the FDA would not have approved a 16 change to [the] label,” which the defendant had not produced. Id. at 573.2 17 In Mensing, the Court held that state law tort claims against generic drug manufacturers 18 based on a failure-to-warn theory were preempted because it was impossible for the generic 19 manufacturers to comply with state laws, which required them to strengthen warnings on labels, 20 and to comply with federal law, which precluded them from doing so. 564 U.S. at 624. The 21 plaintiffs argued that the generic manufacturers could have asked for the FDA’s assistance in 22 23 1 Anderson argues that discovery is necessary before the Court rules on this issue because “neither party is in a position to determine whether” her injuries were caused by branded Singulair 24 or its generic equivalent. The Court is not persuaded, and it evaluates the allegations as drafted to determine whether Anderson pleaded herself out of a claim. 25 2 The Supreme Court subsequently held that “the question of pre-emption is one for a judge 26 to decide, not a jury” and that “‘clear evidence’ is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law 27 and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a 1 getting the brand-name manufacturer to change the label. Id. at 620. The Court, however, 2 rejected that argument and explained that the “question for ‘impossibility’ is whether the private 3 party could independently do under federal law what state law requires of it.” 564 U.S. at 620. 4 Citing several other examples of asking a third-party to intervene to take action that would enable 5 them to comply with state law, the Court concluded that if it accepted the plaintiffs’ argument, it 6 would render conflict preemption illusory. Id. at 620-21. 7 Finally, in Bartlett, the Supreme Court held that design defect claims against a generic 8 drug manufacturer were preempted because the only way for the manufacturer to comply with 9 state law would be to alter the label on its drug, which federal law precluded. 570 U.S. at 480, 10 486-87. The Court also rejected the reasoning by the Court of Appeals that the manufacturer 11 could have complied with both laws by choosing not to sell the drug at all. It reasoned that a 12 “stop-selling rationale [was] incompatible with [its] preemption jurisprudence,” which 13 “presume[s] that an actor seeking to satisfy both his federal and state-law obligations is not 14 required to cease acting altogether in order to avoid liability.” Id. at 488. 15 Anderson acknowledges that after the FDA approved Singulair, the Merck Defendants 16 could not unilaterally alter the drug’s design, but she argues her claims are based on what 17 Defendants could have done prior to FDA approval. Defendants argue the Court should follow 18 Yates v. Ortho-McNeil-Janssen Pharmaceuticals, which concluded pre-approval claims would be 19 preempted. 808 F.3d 281, 293 (6th Cir. 2015). To date, the Sixth Circuit remains the only Circuit 20 to have addressed this issue. 21 In Yates, the plaintiff suffered a stroke after using defendants’ brand-name contraceptive 22 drug and brought a strict liability design defect claim under New York law. Id. at 286. 23 Defendants moved for summary judgment and argued the claim was preempted. That court 24 rejected the argument that Bartlett and Mensing “extend[ed] to all design defect claims for both 25 generic and brand-name drug manufacturer[s.]” Id. at 296. Rather, it recognized that “the federal 26 statutes and regulations for brand-name and generic drugs are sometimes different” and that 27 “brand-name and generic drugs may face different impossibility preemption results in some 1 The court then examined the defendants’ duties under state law, which provided that a 2 design defect existed when the product “was not reasonably safe because there was a substantial 3 likelihood of harm and it was feasible to design the product in a safer manner.” Id. at 297. Thus, 4 state law allowed the defendants to avoid liability by choosing a safer design for the drug. Id. 5 Second, it examined the duties imposed by federal law and agreed that federal law would not have 6 precluded the defendants from creating and submitting a safer design to the FDA for approval. Id. 7 at 299. However, the court found the plaintiff’s argument about a pre-approval duty “too 8 attenuated” and reasoned that “Defendants could not have complied with whatever pre-approval 9 duty might exist without ultimately seeking the FDA’s approval prior to marketing” the drug. Id. 10 at 300. The court also concluded that the plaintiff’s argument that the defendant could have 11 designed a safer drug at the outset was analogous to the “stop-selling” argument the Supreme 12 Court rejected in Bartlett. Therefore, the court concluded the plaintiffs’ pre-approval claims were 13 preempted. Id. at 300; see also Evans v. Gilead Scis., Inc., No. 20-cv-00123-DKW-KJM, 2020 14 WL 5189995, at *9 (D. Hawai‘i Aug. 31, 2020) (concluding pre-approval design defect claims 15 preempted under Hawai‘i law and adopting rationale that because defendant would be required to 16 obtain FDA approval before selling drug it could not act “independently” of FDA); Utts v. Bristol- 17 Myers Squibb Co., 226 F. Supp. 3d 166, 185-86 (S.D.N.Y. 2016) (applying similar reasoning to 18 conclude plaintiff’s pre-approval design defect claim under California law, against brand-name 19 manufacturer, was preempted). 20 Anderson argues the Court should decline to follow Yates and follow the reasoning in 21 Holley v. Gilead Sciences, Inc., 379 F. Supp. 3d 809 (N.D. Cal. 2019). See also, e.g., Gaetano v. 22 Gilead Scis., Inc., 529 F. Supp. 3d 333, 342-44 (D.N.J. 2021). In Holley, the plaintiffs (140 23 individuals from 31 states) asserted the defendant’s drug, Truvada, caused bone and kidney 24 damage and alleged the defendant could have, and did, designed a safer version of the drug by 25 using a different ingredient. The defendant raised impossibility preemption as a defense on a 26 motion to dismiss. 27 The court presumed the relevant state law duty was to have designed Truvada using a 1 considered Yates, but it found “persuasive the weight of authority” from district courts outside the 2 Sixth Circuit, which have found similar claims not preempted. Id. at 823-24. The court reasoned 3 that the defendant failed to cite to any laws that precluded it from “designing a reasonably safe 4 product prior to FDA approval,” in the manner suggested by the plaintiff. Id. at 824 (citations and 5 emphasis omitted). It rejected the Sixth Circuit’s rationale that this theory would be “too 6 attenuated,” because all design defect claims require some hypothetical considerations. It 7 reasoned it would not be “too attenuated to assume” the FDA would approve a safer version of a 8 drug, especially when the plaintiff alleged it had done just that with defendant’s subsequent drugs. 9 Id. (citing Guidry v. Janssen Pharm., Inc., 206 F. Supp. 3d 1187, 1208 (E.D. La. 2016)). 10 The court also concluded that Yates misstated Bartlett’s “stop-selling” rationale. Id. at 825 11 (citing Young v. Bristol-Myers Squibb Co., No. 4:16-cv-00108-DMB-JMV, 2017 WL 706320, at 12 *8 (N.D. Miss. Feb. 22, 2017). “[T]he preapproval theory does not argue that a manufacturer 13 should have stopped acting just that it should have acted differently,” which would not run afoul 14 of “the admonition in Bartlett.” Id. (quoting Young, 2017 WL 706320, at *8). The plaintiffs 15 asserted that the defendant should have offered the FDA a safer drug from the outset. Because the 16 defendant had not presented evidence that it could not have done so and complied with both state 17 and federal law, the court held that “[a]t this stage of the proceedings, Gilead has not satisfied the 18 ‘demanding’ defense of impossibility preemption” for the design defect claims. Id.; accord 19 Gaetano, 529 F. Supp. 3d at 343 (stating that a state law claim based on the assertion that a 20 manufacturer should “act differently” at the “development stage, when the manufacturer is 21 choosing among alternatives and its choice is not dictated by federal law” would not be 22 preempted); In re Zosavax (Zoster Vaccine Live) Prods. Liab. Litig., MDL No. 2848, 2021 WL 23 5235225, at *3-4 (E.D. Pa. 2021 Nov. 10, 2021) (noting split among district courts and following, 24 inter alia, Holley). The Court finds the reasoning of the cases that have declined to follow Yates 25 more persuasive. For the reasons articulated in Holley and based on the facts before the Court, it 26 concludes Defendants have not demonstrated that Anderson’s design defect claims are preempted. 27 If Anderson is able to amend her claims to show they are not time barred, Defendants are free to 1 CONCLUSION 2 For the foregoing reasons, the Court GRANTS, IN PART, AND DENIES, IN PART, 3 Defendants’ motion to dismiss. Although Defendants asked the Court to dismiss Anderson’s 4 || claims with prejudice because she declined their invitation to amend when they raised the statute 5 of limitations issue, there is no evidence of bad faith, and the Court cannot say amendment would 6 || be futile. Accordingly, the Court GRANTS Anderson leave to file an amended complaint by 7 || December 12, 2022. Defendants shall answer or otherwise respond by January 6, 2023. 8 IT ISSO ORDERED. a, 9 || Dated: November 21, 2022 / | / Nits 10 \ i Ht / . JEFFREY, S{ WHIT 11 United Disty/£t Judge 13 16 «17 Oo Z 18 19 20 21 22 23 24 25 26 27 28