Holley et al v. Gilead Sciences, Inc., No. 3:2018cv06972 - Document 75 (N.D. Cal. 2019)

Court Description: ORDER GRANTING IN PART AND DENYING IN PART MOTION TO DISMISS by Judge Jon S. Tigar granting in part and denying in part 45 Motion to Dismiss. Amended Pleadings due by 5/31/2019. (wsnS, COURT STAFF) (Filed on 5/10/2019)

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Holley et al v. Gilead Sciences, Inc. Doc. 75 1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 ADRIAN HOLLEY, et al., 7 Plaintiffs, 8 v. 9 GILEAD SCIENCES, INC., 10 Defendant. 11 United States District Court Northern District of California Case No. 18-cv-06972-JST ORDER GRANTING IN PART AND DENYING IN PART MOTION TO DISMISS Re: ECF No. 45 12 Before the Court is Defendant Gilead Sciences, Inc.’s motion to dismiss. ECF No. 45. 13 14 The Court will grant the motion in part and deny it in part. 15 I. 16 BACKGROUND This case alleges that individuals who have taken one or more of Gilead’s drugs containing 17 tenofovir disoproxil fumarate (“TDF”) have suffered unnecessary kidney and bone damage 18 resulting from Gilead’s failure to provide adequate warnings and its decision to develop drugs 19 containing TDF rather than the safer compound tenofovir alafenamide fumarate (“TAF”). The 20 complaint alleges the following: Plaintiffs have taken one or more drugs manufactured by Gilead 21 that contain TDF. ECF No. 1 ¶ 22. Since 2001, Gilead “has received FDA [Food and Drug 22 Administration] approval for five TDF-based drugs for the treatment of HIV”: Viread in 2001, 23 Truvada in 2004, Atripla in 2006, Complera in 2011, and Stribild in 2012. Id. ¶¶ 188-93. Viread 24 has also been approved to treat Hepatitis B, and Truvada has been approved for use “in 25 combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of 26 sexually acquired HIV-1 in adults at high risk.” Id. ¶¶ 189, 190. Gilead has received FDA 27 approval for three drugs containing TAF that are counterparts to its previously approved TDF 28 drugs: Genvoya in 2015 and Odefsey and Descovy in 2016. Id. ¶¶ 196-98. Genvoya, Odefsey, Dockets.Justia.com 1 and Descovy are “identical to” to Stribild, Complera, and Truvada, respectively, “except for the 2 substitution of TAF for TDF.” Id. United States District Court Northern District of California 3 Prior to the approval of Viread, Gilead had discovered TAF. Id. ¶ 194. “TDF and TAF are 4 two prodrug versions of the same parent drug, tenofovir, though TAF requires a dose more than 5 ten times smaller than TDF to obtain the same therapeutic effect.” Id. “Because TAF can be 6 administered at a much lower does than TDF, its use is associated with less toxicity and fewer side 7 effects.” Id. ¶ 7. Prior to selling its first TDF drug in 2001, “Gilead knew that TDF posed a safety 8 risk to patients’ kidneys and bones, . . . that the relatively high dose of TDF created a greater risk 9 of toxic effects, and that bone and kidney toxicities were even more likely to be seen with long- 10 term use of TDF for the treatment of a virus that, for the foreseeable future, has no cure.” Id. ¶ 5. 11 “Despite knowing that TAF could be given at a much lower, safer dose,” “that TDF causes kidney 12 and bone damage and that TAF is safer for patients’ kidneys and bones, Gilead designed the TDF 13 Drugs to contain TDF rather than safer TAF.” Id. ¶¶ 7, 279. When Gilead began selling its TAF 14 drugs, it “convinced doctors to switch their patients from TDF-based to TAF-based regimens by 15 demonstrating TAF’s superior safety profile over TDF with respect to kidney and bone toxicity – 16 the very benefits that Gilead could have and should have incorporated into its prior product 17 designs but withheld from doctors and patients for over a decade.” Id. ¶ 11. 18 “Stribild is even more toxic to patients’ kidneys and bones than Gilead’s other TDF-based 19 products” because it contains a higher dose of TDF than required. Id. ¶ 14. In addition to TDF, 20 Stribild contains cobicistat, a “pharmacoenhancer or ‘booster’ that inhibits the breakdown of 21 elvitegravir, another active ingredient in Stribild.” Id. ¶ 12. Prior to submitting Stribild for FDA 22 approval, Gilead knew that “TDF-associated renal toxicity occurs more frequently in patients 23 taking TDF as part of a boosted regimen,” and that the TAF dosage in Genvoya, the TAF- 24 equivalent to Stribild, could be reduced “from 25 mg to 10 mg to account for the fact that 25 cobicistat significantly increases tenofovir concentrations.” Id. ¶¶ 13-14. Nonetheless, “Gilead 26 did not reduce the dose of TDF when it designed Stribild.” Id. ¶ 14. 27 Gilead also “failed to adequately warn physicians and patients about the risks and safe use 28 of TDF. Gilead provided only the weakest, inadequate warnings to doctors and patients about the 2 United States District Court Northern District of California 1 need for frequent monitoring of all patients for TDF-associated kidney and bone damage – 2 preventing doctors from detecting early signs of TDF toxicity.” Id. ¶ 15. For example, “after 3 May 21, 2007, the TDF labels do not disclose that adverse kidney and bone events occurred in 4 patients without pre-existing risk factors – which, combined with the warning to only routinely 5 monitor patients at risk – gives the false impression that TDF is only harmful to people otherwise 6 at risk for kidney and bone injuries.” Id. ¶ 346. “Gilead’s monitoring instructions for at risk 7 patients taking Viread, Truvada, Atripla, and Complera, and patients taking Stribild are also 8 inadequate because they fail to recommend a specific, frequent monitoring schedule for doctors to 9 assess patients’ kidney function.” Id. ¶ 347. “Regularly scheduled, frequent monitoring of kidney 10 function is necessary to catch early signs of TDF-induced toxicity and prevent injury because 11 patients are generally asymptomatic during the early stages.” Id. ¶ 345. Early detection of 12 toxicity “is key to preventing serious, potentially irreversible renal injury,” and monitoring also 13 “ensure[s] that patients’ kidneys are healthy enough to continue treatment” or that patients receive 14 necessary dosage adjustments. Id. ¶ 324, 338. 15 Plaintiffs allege a financial motive for Gilead’s alleged conduct. They allege that Gilead 16 stopped developing TAF in 2004, claiming that it was too similar to TDF to continue 17 development, but in reality did so because “Gilead did not want to hurt TDF sales by admitting 18 that its TDF-based products are unreasonably and unnecessarily unsafe.” Id. ¶ 8. Gilead also 19 stood to gain by having two different periods of drug exclusivity: first for TDF drugs and later for 20 TAF drugs. “Only once Gilead realized billions in sales through most of the TDF patent life did it 21 seek to market safer TAF-based versions of its HIV medications.” Id. ¶ 10. Gilead “provides 22 stronger monitoring warnings to physicians and patients in the European Union than it does in the 23 United States for the exact same TDF products. . . . There is no scientific or medical rationale for 24 these differences. Gilead was more concerned with increasing or maintaining crucial U.S. sales 25 than it was in safeguarding patients from the known risks of TDF.” Id. ¶ 16. 26 On the basis of these allegations, Plaintiffs assert design-defect and failure-to-warn claims 27 under multiple states’ product liability and negligence laws. Plaintiffs also assert state-law fraud 28 and consumer protection claims, as well as claims for the breach of implied warranty and 3 1 merchantability. The complaint names 140 plaintiffs from 31 states. ECF No. 1 ¶¶ 24-163. Plaintiffs’ 2 3 counsel filed a nearly identical case, Dowdy v. Gilead Sciences, Inc., Case No. 3:19-cv-00481- 4 JST, on behalf of 25 different plaintiffs from 10 of the 31 states involved in this case. Case No. 5 3:19-cv-00481-JST, ECF No. 1 ¶¶ 23-47. The parties filed consolidated briefing on Gilead’s 6 motion to dismiss in both cases. ECF Nos. 45, 54, 60; Dowdy ECF Nos. 30, 40, 45. The Court 7 granted the parties’ stipulation to consolidate these cases for pretrial purposes on April 29, 2019, 8 and ordered that “[t]he master docket and master file for the consolidated actions shall be 3:18-cv- 9 06972-JST and the consolidated action shall bear the caption Holley, et al. v. Gilead Sciences Inc.” 10 ECF No. 67 at 6. Gilead moves to dismiss all of Plaintiffs’ claims as preempted under federal law. It also United States District Court Northern District of California 11 12 argues that Plaintiffs’ failure-to-warn claims should be dismissed because they do not adequately 13 allege causation, and that their claims under state fraud and consumer protection laws should be 14 dismissed because they do not comply with the heightened pleading requirements of Federal Rule 15 of Civil Procedure 9(b). Finally, Gilead argues that another court’s decision, AIDS Healthcare 16 Foundation, Inc. v. Gilead Sciences, Inc., No. C 16-00443 WHA, 2016 WL 3648623, at *9 (N.D. 17 Cal. July 6, 2016), aff’d, 890 F.3d 986 (Fed. Cir. 2018), establishes that it had no duty to introduce 18 drugs containing TAF at an earlier date, and that Plaintiffs’ claims based on that allegation should 19 therefore be dismissed. 20 II. 21 JURISDICTION This case involves more than 100 plaintiffs, and Gilead does not contest that at least some 22 of the plaintiffs are of diverse citizenship from Gilead, which Plaintiffs allege is a Delaware 23 corporation with a principal place of business in California. ECF No. 1 ¶¶ 24-164. Gilead also 24 does not contest that the total amount in controversy exceeds $5,000,000, exclusive of interest and 25 costs, or that each Plaintiff’s claims exceed $75,000. Id. ¶ 18. This case therefore meets the 26 statutory requirements for a “mass action” under the Class Action Fairness Act of 2005 27 (“CAFA”), and the Court has subject matter jurisdiction under 28 U.S.C. § 1332(d). Corber v. 28 Xanodyne Pharm., Inc., 771 F.3d 1218, 1222 (9th Cir. 2014) (en banc) (“CAFA provides federal 4 1 district courts with original jurisdiction over ‘mass actions’ if the actions meet all of the statutory 2 requirements. 28 U.S.C. § 1332(d).”). The statute excludes from the definition of “mass action” any civil action in which “the 3 4 claims have been consolidated or coordinated solely for pretrial proceedings.” 28 U.S.C. 5 § 1332(d)(11)(B)(ii)(IV). Although the Holley and Dowdy actions have thus far been consolidated 6 only for pretrial purposes, ECF No. 67 at 6, this does not prevent the Court from exercising 7 jurisdiction because the Holley action alone satisfies the statutory requirements for a “mass 8 action.” In addition, all of the plaintiffs in the Dowdy action have diverse citizenship from Gilead, 9 so the Court independently has jurisdiction over that action under 28 U.S.C. § 1332(a)(1). 10 United States District Court Northern District of California 11 III. LEGAL STANDARD A complaint must contain “a short and plain statement of the claim showing that the 12 pleader is entitled to relief.” Fed. R. Civ. P. 8(a). Dismissal under Federal Rule of Civil 13 Procedure 12(b)(6) “is appropriate only where the complaint lacks a cognizable legal theory or 14 sufficient facts to support a cognizable legal theory.” Mendiondo v. Centinela Hosp. Med. Ctr., 15 521 F.3d 1097, 1104 (9th Cir. 2008). A complaint need not contain detailed factual allegations, 16 but facts pleaded by a plaintiff must be “enough to raise a right to relief above the speculative 17 level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). “To survive a motion to dismiss, a 18 complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is 19 plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Twombly, 550 U.S. at 20 570). “A claim has facial plausibility when the plaintiff pleads factual content that allows the 21 court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. 22 While this standard is not a probability requirement, “[w]here a complaint pleads facts that are 23 merely consistent with a defendant’s liability, it stops short of the line between possibility and 24 plausibility of entitlement to relief.” Id. (internal quotation marks and citation omitted). In 25 determining whether a plaintiff has met this plausibility standard, a court must “accept all factual 26 allegations in the complaint as true and construe the pleadings in the light most favorable” to the 27 plaintiff. Knievel v. ESPN, 393 F.3d 1068, 1072 (9th Cir. 2005). 28 Federal Rule of Civil Procedure 9(b) requires that “a party must state with particularity the 5 United States District Court Northern District of California 1 circumstances constituting fraud or mistake” but allows that “[m]alice, intent, knowledge, and 2 other conditions of a person’s mind may be alleged generally.” Allegations of fraud must “be 3 specific enough to give defendants notice of the particular misconduct so that they can defend 4 against the charge and not just deny that they have done anything wrong. Averments of fraud 5 must be accompanied by the who, what, when, where, and how of the misconduct charged.” Vess 6 v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1106 (9th Cir. 2003) (internal quotation marks, 7 alteration, and citation omitted). However, “a plaintiff in a fraud by omission suit will not be able 8 to specify the time, place, and specific content of an omission as precisely as would a plaintiff in a 9 false representation claim,” and such a claim “will not be dismissed purely for failure to precisely 10 state the time and place of the fraudulent conduct.” Falk v. Gen. Motors Corp., 496 F. Supp. 2d 11 1088, 1098-99 (N.D. Cal. 2007); Washington v. Baenziger, 673 F. Supp. 1478, 1482 (N.D. Cal. 12 1987) (“[A] plaintiff cannot plead either the specific time of the omission or the place, as he is not 13 alleging an act, but a failure to act.”). 14 IV. DISCUSSION 15 A. 16 AIDS Healthcare Foundation previously filed an antitrust action concerning Gilead’s TDF- 17 and TAF-based drugs that also sought a declaration of patent invalidity and relief under California 18 and Nevada unfair competition laws. AIDS Healthcare Found., 2016 WL 3648623, at *4. Among 19 the plaintiff’s theories was that: 20 Gilead knew of the efficacy and safety benefits of TAF in 2004 but shelved its clinical trials until 2011, leading to FDA approval (and a grant of NCE exclusivity) in 2015, just before the patents on TDF were set to expire. 21 22 This, AIDS Healthcare contends, delayed the expiration date of Gilead’s NCE exclusivity and thus delayed the moment that competitors would seek to challenge Gilead’s patents on TAF. Further, it left consumers to bear the higher bone and kidney toxicity of TDF longer than necessary. 23 24 25 26 AIDS Healthcare Foundation v. Gilead Id. at *9.1 The court dismissed the California unfair competition law (“UCL”) claim, concluding 27 28 New chemical entity (“NCE”) exclusivity “bars the FDA from approving any application for a drug containing the covered new chemical entity for five years following approval of the first 6 1 1 that Gilead “had no obligation to introduce the improved product at an earlier date. Any 2 competitor could have beaten Gilead to market (and thus NCE exclusivity).” Id. The court 3 explained that delaying introduction of a new product did not violate antitrust law, and “AIDS 4 Healthcare cannot recast its claim that Gilead unreasonably restrained competition by allegedly 5 delaying the release of TAF as a claim under the unfair prong of the UCL.” Id. Gilead seeks to rely on this decision to bar Plaintiffs from asserting any claims based on United States District Court Northern District of California 6 7 the contention that Gilead had a duty to introduce TAF drugs earlier. However, the Court does not 8 find AIDS Healthcare Foundation to be dispositive. First, the case was an antitrust action, which 9 addressed the question of whether Gilead had engaged in anticompetitive conduct. Concluding 10 that Gilead owed no duty to its competitors says nothing about any duties Gilead might owe to 11 consumers under state tort law.2 Moreover, the persuasive weight of the court’s decision is 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 NDA [new drug application] containing that ingredient. The FDA also cannot receive applications for drugs containing that ingredient until the fourth year following the approval of the first NDA.” AIDS Healthcare Found., 2016 WL 3648623, at *2. Even AIDS Healthcare Foundation’s UCL claim was based on alleged anticompetitive conduct, rather than a violation of any duty to consumers under state-law theories of strict liability and negligence: 2 AIDS Healthcare’s second theory (which appears only in its brief, not in its complaint) fares no better. AIDS Healthcare contends that Gilead knew of the efficacy and safety benefits of TAF in 2004 but shelved its clinical trials until 2011, leading to FDA approval (and a grant of NCE exclusivity) in 2015, just before the patents on TDF were set to expire. This, AIDS Healthcare contends, delayed the expiration date of Gilead’s NCE exclusivity and thus delayed the moment that competitors would seek to challenge Gilead’s patents on TAF. Further, it left consumers to bear the higher bone and kidney toxicity of TDF longer than necessary. AIDS Healthcare fails to explain how this “delay” constituted unfair competition. Gilead’s patents gave it a monopoly over both TDF and TAF. It had no obligation to introduce the improved product at an earlier date. Any competitor could have beaten Gilead to market (and thus NCE exclusivity). “Without more, it is not unlawful [under antitrust law] for any competitor in any market to delay the introduction of a new product or an entire line of new products until, as [the plaintiff] alleged in this case, the competition forces such introduction.” Foremost Pro Color, Inc. v. Eastman Kodak Co., 703 F.2d 534, 545 (9th Cir. 1983). Under Chavez, AIDS Healthcare 7 1 diminished by the facts that the plaintiff raised this theory only in its opposition brief and not in 2 the complaint, and the court allowed the plaintiff to seek leave to amend. Id. at *9. Finally, 3 Gilead does not even attempt to argue that the requirements for claim preclusion or issue 4 preclusion are satisfied. AIDS Healthcare Foundation does not warrant dismissal of any of 5 Plaintiffs’ claims. 6 B. 7 Gilead argues that Plaintiffs’ claims based on design defect and failure to warn are 8 preempted by federal law because it is impossible to comply with both state and federal 9 regulations.3 Preemption analysis “must be guided by two cornerstones”: First, “the purpose of Congress is the ultimate touchstone in every pre-emption case.” Second, “[i]n all pre-emption cases, and particularly in those in which Congress has ‘legislated . . . in a field which the States have traditionally occupied,’ . . . we ‘start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.’” 10 11 United States District Court Northern District of California Preemption 12 13 14 Wyeth v. Levine, 555 U.S. 555, 565 (2009) (citations omitted) (alterations in original) (quoting 15 Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996)). “Impossibility pre-emption is a demanding 16 defense,” and the burden for demonstrating impossibility rests with the party asserting preemption. 17 Id. at 573 (concluding that “Wyeth has failed to demonstrate that it was impossible for it to 18 comply with both federal and state requirements”). In the past decade, the Supreme Court has considered three preemption cases concerning 19 20 drug manufacturers. First, in Wyeth v. Levine, the Court considered “whether the FDA’s drug 21 labeling judgments ‘preempt state law product liability claims premised on the theory that 22 23 cannot recast its claim that Gilead unreasonably restrained competition by allegedly delaying the release of TAF as a claim under the unfair prong of the UCL. 24 25 26 27 28 Id. at *9 (emphasis and alterations in original). Gilead’s attempt to recast AIDS Healthcare Foundation as a “consumer protection” case by quoting selectively from this passage, ECF No. 60 at 16-17, falls flat when the language is read in its entirety. Gilead argues that “Plaintiffs’ remaining causes of action are based on the same flawed theories as their design defect and failure to warn claims” and are therefore preempted for the same reasons. ECF No. 45 at 22. 8 3 1 different labeling judgments were necessary to make drugs reasonably safe for use.’” 555 U.S. at 2 563 (quoting petition for certiorari). Like Gilead, Wyeth manufactured a brand-name drug, 3 Phenergan, and contended that it “would have been impossible for it to comply with the state-law 4 duty to modify Phenergan’s labeling without violating federal law.” Id. The Court explained the 5 relevant provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”): 6 7 8 9 10 United States District Court Northern District of California 11 12 13 The FDA’s premarket approval of a new drug application includes the approval of the exact text in the proposed label. See 21 U.S.C. § 355; 21 CFR § 314.105(b) (2008). Generally speaking, a manufacturer may only change a drug label after the FDA approves a supplemental application. There is, however, an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency’s approval. Among other things, this “changes being effected” (CBE) regulation provides that if a manufacturer is changing a label to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,” it may make the labeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval. §§ 314.70(c)(6)(iii)(A), (C). 14 Id. at 568. The Court also explained that the CBE regulation was amended in 2008 to provide 15 “that a manufacturer may only change its label ‘to reflect newly acquired information.’” Id. 16 (quoting 73 Fed. Reg. 49603, 49609). “Newly acquired information . . . may include (but is not 17 limited to) data derived from new clinical studies, reports of adverse events, or new analyses of 18 previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a 19 different type or greater severity or frequency than previously included in submissions to FDA.” 20 21 C.F.R. § 314.3(b). “The rule accounts for the fact that risk information accumulates over time 21 and that the same data may take on a different meaning in light of subsequent developments.” 22 Levine, 555 U.S. at 569. Although Wyeth had previously worked with the FDA to change 23 Phenergan’s labeling after the first incident of gangrene and amputation resulted from a Phenergan 24 injection in 1967, the Court found persuasive that, “[i]n later years, as amputations continued to 25 occur, Wyeth could have analyzed the accumulating data and added a stronger warning about IV- 26 push administration of the drug.” Id. at 569-70. The FDA “retains authority to reject labeling 27 changes made pursuant to the CBE regulation in its review of the manufacturer’s supplemental 28 application,” but this fact was not dispositive: “[A]bsent clear evidence that the FDA would not 9 1 have approved a change to Phenergan’s label, we will not conclude that it was impossible for 2 Wyeth to comply with both federal and state requirements.”4 Id. at 571. In PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), the Supreme Court reached a different United States District Court Northern District of California 3 4 result when considering failure-to-warn claims against generic, rather than brand-name, drug 5 manufacturers. The Court explained that “brand-name and generic drug manufacturers have 6 different federal drug labeling duties.” Id. at 613. “A brand-name manufacturer seeking new drug 7 approval is responsible for the accuracy and adequacy of its label,” but “[a] manufacturer seeking 8 generic drug approval, on the other hand, is responsible for ensuring that its warning label is the 9 same as the brand name’s.” Id. The Court concluded that generic manufacturers cannot use “the 10 CBE process to unilaterally strengthen their warning labels” and assumed without deciding that 11 FDA regulations require that “[g]eneric drug manufacturers that become aware of safety problems 12 must ask the agency to work toward strengthening the label that applies to both the generic and 13 brand-name equivalent drug.” Id. at 614, 616-17. The Court found it would be impossible for 14 generic manufacturers to comply with both state and federal duties: “Although requesting FDA 15 assistance would have satisfied the Manufacturers’ federal duty, it would not have satisfied their 16 state tort-law duty to provide adequate labeling. State law demanded a safer label; it did not 17 instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.” 18 Id. at 619. “[F]ederal law would permit the Manufacturers to comply with the state labeling 19 requirements if, and only if, the FDA and the brand-name manufacturer changed the brand-name 20 label to do so.” Id. at 620. This was sufficient to establish impossibility preemption because the 21 manufacturers could not “independently do under federal law what state law requires of it,” id. – 22 that is, “federal law directly conflicts with state law,” id. at 624 n.8. “[W]hen a party cannot 23 satisfy its state duties without the Federal Government’s special permission and assistance, which 24 is dependent on the exercise of judgment by a federal agency, that party cannot independently 25 satisfy those state duties for pre-emption purposes.” Id. at 623-24. The Court explained that 26 27 28 4 On January 7, 2019, the Supreme Court heard oral argument in Merck Sharp & Dohme Corp. v. Albrecht (No. 17-290), an appeal from In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), cert. granted sub nom., 138 S. Ct. 2705 (June 28, 2018), in which the Third Circuit opined on the “clear evidence” standard. 10 United States District Court Northern District of California 1 Levine “is not to the contrary.” Id. at 624. “The Court in [Levine] asked what the drug 2 manufacturer could independently do under federal law, and in the absence of clear evidence that 3 Wyeth could not have accomplished what state law required of it, found no pre-emption.” Id. at 4 624 n.8. 5 In the third case to consider preemption in this context, the Supreme Court held that “state- 6 law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal 7 law” as to generic manufacturers. Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 476 (2013). The 8 Court “[began] by identifying [a drug manufacturer’s] duties under state law” and determined that 9 New Hampshire law “requires manufacturers to ensure that the products they design, manufacture, 10 and sell are not ‘unreasonably dangerous.’ The New Hampshire Supreme Court has recognized 11 that this duty can be satisfied either by changing a drug’s design or by changing its labeling.” Id. 12 at 480, 482. A generic manufacturer could not change the drug’s design, both because federal law 13 “requires a generic drug to have the same active ingredients, route of administration, dosage form, 14 strength, and labeling as the brand-name drug on which it is based,” and because, in this case, the 15 drug had a “simple composition” that “is chemically incapable of being redesigned.” Id. at 483- 16 84. As a result, the only way for Mutual to comply with New Hampshire law would be for it to 17 strengthen the drug’s warning label. Id. at 484. But, “[a]s [Mensing] made clear, federal law 18 prevents generic drug manufacturers from changing their labels. Thus, federal law prohibited 19 Mutual from taking the remedial action required to avoid liability under New Hampshire law.” Id. 20 at 486 (citations omitted). The Court rejected the “‘stop selling’ rationale,” adopted by the Court 21 of Appeals, that compliance with both laws was not impossible because Mutual could have chosen 22 not to manufacture the drug at all. Id. at 488. The Court explained that its “pre-emption cases 23 presume that an actor seeking to satisfy both his federal- and state-law obligations is not required 24 to cease acting altogether in order to avoid liability.” Id. 25 Reading these cases together, this Court discerns the following two-step analysis for 26 impossibility preemption in the drug-manufacturing context: First, courts must determine whether 27 a drug manufacturer may independently take action that complies with both state and federal law. 28 An action is independent under this analysis if the manufacturer can take such action without prior 11 1 FDA approval, even if the FDA may subsequently reject approval of the action post hoc. If 2 independent action is not possible, then the state-law claims are preempted. If independent action 3 is possible, then the claims are preempted only if there is clear evidence that the FDA would not 4 grant approval. Levine, 555 U.S. at 571 (“[A]bsent clear evidence that the FDA would not have 5 approved a change to Phenergan’s label, we will not conclude that it was impossible for Wyeth to 6 comply with both federal and state requirements”). 1. 7 Plaintiffs allege that Gilead violated various state laws by designing and submitting for 8 United States District Court Northern District of California 9 Design-Defect Claims Based on Drug Composition FDA approval drugs that contained TDF rather than TAF, which they allege was a safer 10 alternative available at the time. Plaintiffs also allege that Gilead should have designed Stribild 11 with a lower dose of TDF. Gilead argues that these design-defect claims based on drug 12 composition are preempted. Before considering whether a manufacturer can comply with both state and federal law, 13 14 courts must determine a manufacturer’s duties under each law. E.g., Bartlett, 570 U.S. at 480 15 (“We begin by identifying petitioner’s duties under state law.”); Mensing, 564 U.S. at 611 (“Pre- 16 emption analysis requires us to compare federal and state law. We therefore begin by identifying 17 the state tort duties and federal labeling requirements applicable to the Manufacturers.”). The 18 parties here have not attempted to describe Gilead’s duties under any particular state law.5 The 19 question presented by Gilead’s motion is therefore not whether any particular state law is 20 preempted but, rather, whether all state-law claims based on pre-approval drug composition are 21 preempted. For purposes of this analysis, the Court assumes without deciding that the state laws 22 23 24 25 26 27 28 5 On reply, Gilead makes a cursory argument that one of the cases relied on by Plaintiffs “ultimately dismissed plaintiff’s pre-approval design defect claim as a matter of state law, because ‘courts throughout the country have held that a party may not show a reasonable alternative design by pointing to the availability of a different drug available for the same purpose.’” ECF No. 60 at 10-11 (emphasis in original) (quoting Young v. Bristol-Myers Squibb Co., No. 4:16-CV-00108DMB-JMV, 2017 WL 706320, at *10 (N.D. Miss. Feb. 22, 2017)). But “[i]t is inappropriate to consider arguments raised for the first time in a reply brief.” Ass’n of Irritated Residents v. C & R Vanderham Dairy, 435 F. Supp. 2d 1078, 1089 (E.D. Cal. 2006). Moreover, the Young court noted that whether an alleged alternative design is instead a different product is generally a question of fact. Young, 2017 WL 706320, at *11. It nonetheless concluded that the plaintiff’s allegations failed as a matter of law because they “point[ed] to drugs which by their very nature perform a different function.” Id. The allegations in this case are distinguishable. 12 1 invoked by Plaintiffs required Gilead to use TAF rather than TDF, and to use a lower dose of TDF 2 before submitting Stribild to the FDA for approval. The Supreme Court has not addressed whether federal law preempts design-defect claims United States District Court Northern District of California 3 4 against a brand-name manufacturer on grounds that, prior to initial FDA approval, the drug should 5 have had a different composition.6 Some language from Bartlett could arguably be read broadly to 6 cover all design-defect claims, including those brought against brand-name manufacturers. E.g., 7 570 U.S. at 477 (“Once a drug – whether generic or brand-name – is approved, the manufacturer is 8 prohibited from any major changes to the ‘qualitative or quantitative formulation of the drug 9 product, including active ingredients, or in the specifications provided in the approved 10 application.’” (quoting 21 C.F.R. § 314.70(b)(2)(i))); id. at 490 (“[A]s discussed at length above, 11 we hold that state-law design-defect claims like New Hampshire’s that place a duty on 12 manufacturers to render a drug safer by either altering its composition or altering its labeling are in 13 conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition 14 or labeling.” (citation omitted)). However, Bartlett involved only a generic manufacturer, and the 15 Supreme Court has recognized that brand-name and generic manufacturers are subject to different 16 federal requirements. E.g., Mensing, 564 U.S. at 613. As the Sixth Circuit case relied on heavily 17 by Gilead, and which the Court discusses below, explained, “the Bartlett Court did not reach the 18 sweeping conclusion that all design defect claims are preempted by federal law, but rather applied 19 the impossibility preemption analysis to the plaintiff’s design defect claim regarding a generic 20 drug, and clarified that preemption cannot be avoided if the only way a manufacturer can comply 21 with both federal and state law is to exit the market.” Yates v. Ortho-McNeil-Janssen Pharm., 22 Inc., 808 F.3d 281, 296 (6th Cir. 2015). The Sixth Circuit is the only Court of Appeals to have ruled on whether pre-approval 23 24 design-defect claims against a brand-name manufacturer are preempted. In Yates, the court noted 25 26 27 28 Plaintiffs’ opposition makes clear that they are not pursuing claims that Gilead should have pursued a different drug composition after approval. ECF No. 54 at 9 (arguing that “no federal law prevented Gilead from designing its TDF drugs to be safer before U.S. Food and Drug Administration (‘FDA’) approval”); id. at 21 (“Gilead’s remaining cases are inapposite because they did not address allegations that the manufacturer should have changed the drug design before approval.”). The Court therefore does not consider whether post-approval claims are pre-empted. 13 6 1 that “counsel for defendants has cited no federal law that restricts a brand-name drug manufacturer 2 from designing a reasonably safe product prior to FDA approval”; that the plaintiff argued that the 3 existence of a different contraceptive that was chemically distinct and marketed in other countries 4 “shows that redesign of ORTHO EVRA® [the contraceptive at issue] was possible prior to 5 submitting for FDA approval”; and that the defendants “have offered no evidence that the FDA 6 would have exercised its authority to prohibit defendants from creating and submitting such a 7 design for approval.” 808 F.3d at 299. Relying on Mensing, the court found that these facts were 8 insufficient to escape preemption: 9 10 United States District Court Northern District of California 11 12 13 14 15 16 But Yates’s argument regarding defendants’ pre-approval duty is too attenuated. To imagine such a pre-approval duty exists, we would have to speculate that had defendants designed ORTHO EVRA® differently, the FDA would have approved the alternate design. Next, we would have to assume that Yates would have selected this method of birth control. Further yet, we would have to suppose that this alternate design would not have caused Yates to suffer a stroke. This is several steps too far. Even if New York law requires defendants to produce and market a different design, the ultimate availability to Yates is contingent upon whether the FDA would approve the alternate design in the first place. . . . Defendants could not have complied with whatever pre-approval duty might exist without ultimately seeking the FDA’s approval prior to marketing ORTHO EVRA®, and certainly prior to Yates’s use of the drug. Id. at 299-300. The court also concluded that allowing a pre-approval claim to proceed would run 17 18 19 20 afoul of Bartlett’s admonition that an actor seeking to comply with both state and federal law need not “cease acting altogether in order to avoid liability.” Id. at 300 (quoting Bartlett, 570 U.S. at 488). “In contending that defendants’ pre-approval duty would have resulted in a birth control patch with a different formulation,” the court reasoned, “Yates essentially argues that defendants 21 should never have sold the FDA-approved formulation of ORTHO EVRA® in the first place. We 22 reject this never-start selling rationale for the same reasons the Supreme Court in Bartlett rejected 23 the stop-selling rationale of the First Circuit.” Id. 24 District courts that have considered the question have ruled both ways. Of those courts 25 that are not bound by the Sixth Circuit’s ruling in Yates, a majority has found no preemption under 26 these circumstances. In re Xarelto (Rivaroxaban) Prods. Liab. Litig., No. MDL 2592, 2017 WL 27 3188456, at *6 (E.D. La. July 21, 2017); Young v. Bristol-Myers Squibb Co., No. 4:16-CV-0010828 14 United States District Court Northern District of California 1 DMB-JMV, 2017 WL 706320, at *7-8 (N.D. Miss. Feb. 22, 2017); Guidry v. Janssen Pharm., 2 Inc., 206 F. Supp. 3d 1187, 1206-09 (E.D. La. 2016); Sullivan v. Aventis, Inc., No. 14-CV-2939- 3 NSR, 2015 WL 4879112, at *6 (S.D.N.Y. Aug. 13, 2015); Estate of Cassel v. Alza Corp., No. 12- 4 CV-771-WMC, 2014 WL 856023, at *2-6 (W.D. Wis. Mar. 5, 2014). Gilead cites only two 5 district court cases outside the Sixth Circuit that have addressed pre-approval claims. In the first, 6 the court did not rely on Yates but reached the same conclusion: “The complaint’s allegations of 7 harm due to the design defect go to the nature of the composition of the drug. The defendants had 8 no ability to alter that composition without prior approval of the FDA.” Utts v. Bristol-Myers 9 Squibb Co., 226 F. Supp. 3d 166, 186 (S.D.N.Y. 2016). The court therefore dismissed the design- 10 defect claims with prejudice. Id. In addition to being against the weight of authority, the Utts 11 decision is unpersuasive because it relied on portions of the lead opinion in Mensing that did not 12 constitute the opinion of the Court. Id. (quoting Mensing, 564 U.S. at 622-23); see Mensing, 564 13 U.S. at 607 (syllabus noting that Part III-B-2 of Justice Thomas’s opinion was joined by only three 14 other Justices). In the second case, the court cited Yates for the proposition that “it is likely, even 15 if Enbrel [the drug in question] is capable of redesign, that any claim that Defendants should have 16 changed Enbrel’s design before seeking FDA approval would likewise be preempted.” Small v. 17 Amgen, Inc., No. CV 2:12-476-FTM29-CM, 2016 WL 4942078, at *2 (M.D. Fla. Jan. 25, 2016). 18 But the court went on to determine that the questions “are matters for post-discovery dispositive- 19 motion practice, not a motion for judgment on the pleadings.” Id. It therefore does not support 20 dismissal on preemption grounds. 21 Additionally, a case raising similar allegations against Gilead regarding its TDF and TAF 22 drugs is currently pending in California state court. The judge in that case recently distinguished 23 Yates and overruled Gilead’s demurrer as to the plaintiffs’ pre-approval design-defect claims. 24 Lujano v. Gilead Scis., Inc., No. BC702302, at 2-4 (Cal. Sup. Ct. Feb. 13, 2019) (ECF No. 55-1 25 at 3-5). 26 The Court finds persuasive the weight of authority against a finding of preemption. As 27 noted above, the Court must first consider whether Gilead could take independent action in 28 compliance with both state and federal law. The question is not whether a drug manufacturer can 15 United States District Court Northern District of California 1 “independently sell pharmaceutical drugs without FDA approval”; it is whether “a drug 2 manufacturer [can] independently design a reasonably safe drug in compliance with its state-law 3 duties before seeking FDA approval.” Guidry, 206 F. Supp. 3d at 1208. That a brand-name 4 manufacturer cannot market a redesigned version of an approved drug without first seeking 5 additional FDA approval does not address whether the “manufacturer was required to use the 6 allegedly defective design in the first place.” Trahan v. Sandoz, Inc., No. 3:13-cv-350-J-34MCR, 7 2015 WL 2365502, at *6 n.5 (M.D. Fla. Mar. 26, 2015). Gilead “has cited no federal law that 8 restricts a brand-name drug manufacturer from designing a reasonably safe product prior to FDA 9 approval” and, in particular, has identified no federal law that would have prevented it from 10 developing and submitting for approval drugs that contained TAF rather than TDF, or from 11 presenting for approval a version of Stribild with a lower dose of TDF. Sullivan, 2015 WL 12 4879112, at *6 (emphasis in original). At this stage of the proceedings, the Court therefore 13 concludes that Gilead could have independently complied with both state and federal law prior to 14 submitting the TDF drugs for FDA approval. Because Gilead has not presented “clear evidence” 15 that the FDA would not have approved the allegedly safer versions of the drugs that Plaintiffs 16 contend would have complied with state law, Plaintiffs’ pre-approval design-defect claims are not 17 preempted. Levine, 555 U.S. at 571. 18 19 20 21 22 23 24 The Court rejects the Yates court’s “too attenuated” theory because, as the Guidry court reasoned: [T]he Sixth Circuit merely outlines the requisite assumptions for all defective design claims. . . . Indeed, every defective design claim requires consideration of hypothetical scenarios – what different steps could have been taken that may have prevented the plaintiff’s injury. The only added assumption in the pharmaceutical context is that the FDA would have approved the safer, hypothetical drug. It is not too attenuated to assume that the FDA would approve a safer, alternative design of a drug that it has already approved. 206 F. Supp. 3d at 1208 (emphasis in original). This is especially true where, as here, Plaintiffs 25 allege that three of the allegedly safer drugs were actually approved by the FDA years later. 26 Lujano at 3-4 (ECF No. 55-1 at 4-5). 27 Similarly, the Court agrees that “Yates misstates the ‘stop selling’ rationale explained in 28 16 United States District Court Northern District of California 1 Bartlett.” Young, 2017 WL 706320, at *8. Under Bartlett, “an actor seeking to satisfy both his 2 federal- and state-law obligations is not required to cease acting altogether in order to avoid 3 liability.” 570 U.S. at 488. But “[t]he preapproval theory does not argue that a manufacturer 4 should have stopped acting, just that it should have acted differently.” Young, 2017 WL 706310, 5 at *8 (emphasis in original). A pre-approval theory of liability in this case “does not run afoul of 6 the admonition in Bartlett” because “Plaintiffs’ argument would not require [Gilead] to stop 7 selling in order to comply with both state and federal law.” Lujano at 4 (ECF No. 55-1 at 5). 8 Plaintiffs do not argue that Gilead “should have complied with both federal and state law by not 9 selling a drug. Rather Plaintiffs contend that, under state law, [Gilead] should have offered for 10 FDA approval a drug formulation with fewer side effects, and that [Gilead] could have complied 11 with both state and federal law by formulating a drug with TAF, a formulation that eventually was 12 approved by the FDA.” Id. Thus, Bartlett’s rejection of the “stop-selling” rationale does not 13 mandate preemption of Plaintiffs’ state-law design-defect claims. 14 15 16 At this stage of the proceedings, Gilead has not satisfied the “demanding” defense of impossibility preemption as to those claims. Levine, 555 U.S. at 573. 2. Failure-to-Warn Claims 17 Gilead argues that Plaintiffs’ failure-to-warn claims are preempted under Buckman 18 Company v. Plaintiffs’ Legal Committee, in which the Supreme Court held that “[s]tate-law fraud- 19 on-the-FDA claims” – i.e., claims that a defendant caused injuries based on its fraudulent 20 representations to the FDA – are preempted. 531 U.S. 341, 348 (2001). The Court disagrees. 21 Claims are preempted under Buckman where they are based on a “fraud-on-the agency theory” or 22 “exist solely by virtue of the FDCA disclosure requirements” and not “traditional state tort law 23 principles.” Id. at 352-53. By contrast, where “failure-to-warn claims . . . [do] not arise solely by 24 virtue” of federal law, there is no preemption under Buckman because “there is no suggestion that 25 Congress intended to displace traditional tort law by making all policing of medical labels and 26 warnings the exclusive province of the FDA.” McClellan v. I-Flow Corp., 776 F.3d 1035, 27 1040-41 (9th Cir. 2015). Plaintiffs’ claims here are similar to the claim at issue in McClellan, 28 where the plaintiff alleged that defendant “negligently failed to warn that its pain pump should not 17 1 be used in intra-articular spaces such as the glenohumeral joint.” Id. at 1037. Gilead argues that 2 McClellan is distinguishable based on the following excerpt: 3 The allegations at issue occur outside the context of the regulatory process, unlike in Buckman. Where the plaintiff in Buckman alleged that the defendant made fraudulent representations during the market approval process, to the FDA, McClellan’s requested instructions here have little to do with direct regulatory interaction with the FDA. 4 5 6 Id. at 1041 (emphasis in original) (citation omitted). But the allegations at issue here did occur 7 outside the regulatory process in the same way that McClellan’s did: They are based on an alleged 8 failure to warn consumers, and not on any contention that Gilead made misrepresentations to the 9 FDA. Plaintiffs’ claims are not preempted under Buckman. 10 a. United States District Court Northern District of California 11 Pre-Approval Nor are Plaintiffs’ claims preempted to the extent that Plaintiffs contend that Gilead should 12 have submitted different warnings as part of their initial submissions for FDA approval. Just as 13 Gilead has pointed to no federal law that would have prevented it from submitting TAF drugs 14 rather than TDF drugs for approval in the first instance, it has also cited no federal law that would 15 prevent a drug manufacturer from submitting a different warning label to the FDA prior to initial 16 approval of a drug.7 As one district court has explained, “[a]lthough defendants are correct in 17 stating the labeling language must not deviate from that which was approved by the FDA, 18 defendants still possessed the ability to implement stronger warning language into labeling, by 19 submitting stronger warning language for FDA approval.” In re Actos (Pioglitazone) Prods. Liab. 20 Litig., No. 12-CV-00064, 2014 WL 60298, at *7 (W.D. La. Jan. 7, 2014) (also noting that a 21 manufacturer may seek FDA approval “by way of a CBE or prior approval submissions,” a post- 22 approval option that the Court discusses below). 23 The Court does not find the cases relied on by Gilead to be persuasive. The First Circuit 24 interpreted Levine as barring claims “based on information available at the commencement of 25 marketing, while allowing the states to reach contrary conclusions when new information not 26 27 28 As with claims regarding drug composition, the parties do not discuss Gilead’s duties under particular state laws regarding drug labeling. For purposes of this motion, the Court assumes without deciding that the state laws invoked by Plaintiffs require Gilead to use different labeling. 18 7 United States District Court Northern District of California 1 considered by the FDA develops.” In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 2 F.3d 34, 41 (1st Cir. 2015). Similarly, a district court has interpreted Levine as “plainly 3 preempt[ing]” any claim “based on information known to the FDA . . . when the label at issue here 4 was approved.” Maze v. Bayer Healthcare Pharm. Inc., No. 4:18-CV-21-TAV-CHS, 2019 WL 5 1062387, at *3 (E.D. Tenn. Mar. 6, 2019). But Levine rejected Wyeth’s contention that, “[o]nce 6 the FDA has approved a drug’s label, a state-law verdict may not deem the label inadequate, 7 regardless of whether there is any evidence that the FDA has considered the stronger warning at 8 issue.” 555 U.S. at 573-74. And the Supreme Court considered only a manufacturer’s duties once 9 a drug, including its labeling, had already been approved. Although, as discussed below, the 10 question of what information was presented to the FDA is relevant in the post-approval context, 11 the Court does not read Levine as requiring preemption of all failure-to-warn claims, including 12 pre-approval claims, based on material that has been presented to the FDA. Gilead also relies on 13 the Utts court’s conclusion that, “[t]o the extent that the failure to warn claims are premised on the 14 adequacy of the label as approved by the FDA when the drug was first marketed in the United 15 States, they are preempted.” 226 F. Supp. 3d at 184 (citing regulations setting forth FDA labeling 16 requirements). But the cited labeling requirements provide only that a new drug application must 17 contain certain proposed information. See 21 U.S.C. § 355(b)(1)(F); 21 C.F.R. § 314.50(c)(2)(i). 18 They do not conflict with any state-law duties regarding adequacy of warnings, and it is therefore 19 not impossible for a manufacturer to comply with both state and federal law prior to submitting a 20 new drug application to the FDA for approval. Plaintiffs’ pre-approval failure-to-warn claims are 21 not preempted. 22 23 b. Post-Approval Levine, 555 U.S. 555, presents the relevant analytical framework for Plaintiffs’ post- 24 approval failure-to-warn claims. As discussed above, the Supreme Court held in Levine that such 25 claims against brand-name manufacturers are not preempted if the manufacturer could 26 independently alter the drug label under the CBE regulation and there is not “clear evidence that 27 28 19 United States District Court Northern District of California 1 the FDA would not have approved a change to [the drug’s] label.”8 Id. at 568-72. “[T]o properly 2 plead and then prove a state law failure-to-warn claim based on post-drug-release information . . . 3 that is not preempted by the FDCA, a plaintiff must plead ‘a labeling deficiency that [Defendants] 4 could have corrected using the CBE regulation.’” Gibbons v. Bristol-Myers Squibb Co. 919 F.3d 5 699, 708 (2d Cir. 2019) (alteration in original) (quoting In re Celexa, 779 F.3d at 41). 6 The parties dispute whether Plaintiffs’ allegations satisfy this test. Specifically, Gilead 7 argues that Plaintiffs do not allege any “newly acquired information,” as required by the 2008 8 amendments to the CBE regulation. Federal regulations define “newly acquired information” as 9 “data, analyses, or other information not previously submitted to the Agency.” 21 C.F.R. 10 § 314.3(b). It “may include (but is not limited to) data derived from new clinical studies, reports 11 of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the 12 studies, events, or analyses reveal risks of a different type or greater severity or frequency than 13 previously included in submissions to FDA.” Id. The Supreme Court explained that: 14 17 The rule accounts for the fact that risk information accumulates over time and that the same data may take on a different meaning in light of subsequent developments: “[I]f the sponsor submits adverse event information to FDA, and then later conducts a new analysis of data showing risks of a different type or of greater severity or frequency than did reports previously submitted to FDA, the sponsor meets the requirement for ‘newly acquired information.’” 18 Levine, 555 U.S. at 569 (quoting 73 Fed. Reg. at 49607). Levine arose after trial, and the Supreme 19 Court noted that “[t]he record is limited concerning what newly acquired information Wyeth had 20 or should have had about the risks of IV-push administration of Phenergan because Wyeth did not 21 argue before the trial court that such information was required for a CBE labeling change.” Id. 22 The label “warned of the danger of gangrene and amputation following inadvertent intra-arterial 23 injection,” but “Levine alleged that the labeling was defective because it failed to instruct 24 clinicians to use the IV-drip method of intravenous administration instead of the higher risk IV- 25 push method.” Id. at 560. The Court found it sufficient that Levine “present[ed] evidence of at 15 16 26 27 28 Gilead does not argue that there exists “clear evidence” that the FDA would not have approved the labeling changes that Plaintiffs contend were necessary. The Court therefore does not address that component of the preemption analysis. 20 8 1 least 20 incidents prior to her injury in which a Phenergan injection resulted in gangrene and an 2 amputation” and that, “[i]n later years, as amputations continued to occur, Wyeth could have 3 analyzed the accumulating data and added a stronger warning about IV-push administration of the 4 drug.” Id. at 569-70. Although it is not clear from the opinion, it appears that the Supreme Court 5 found these later incidents qualified as “newly acquired information” in part because Wyeth only 6 notified the FDA “[a]fter the first such incident came to Wyeth’s attention in 1967,” and not after 7 subsequent incidents occurred. Id. at 569. United States District Court Northern District of California 8 The Ninth Circuit has not considered sufficiency of claims in this context, but two other 9 circuits have affirmed dismissal of failure-to-warn claims that, in their views, failed to adequately 10 allege “newly acquired information,” and another circuit has found claims to be preempted based 11 on the plaintiff’s failure to present such information at trial. The First Circuit found claims to be 12 preempted where the labeling change sought by the plaintiffs “was plainly known to the FDA 13 prior to approving the label,” and the CBE procedure therefore could not have been used to 14 implement that change. In re Celexa, 779 F.3d at 43. Similarly, the Second Circuit found 15 preempted claims based on allegations that “[b]efore and after marketing Eliquis, [D]efendants 16 became aware of many reports of serious hemorrhaging in users of [their] drugs” and that 17 “[n]umerous . . . studies published after Eliquis’ approval in 2012 confirm the problematic 18 bleeding events associated with Eliquis.” Gibbons, 919 F.3d at 708 (alterations in original). The 19 court explained that the complaint “provides no basis upon which the court could conclude that the 20 bleeding events covered by the alleged ‘reports’ and ‘studies’ presented a different type of risk 21 than those the company had discussed with the FDA, or were more severe or more frequent than 22 bleeding events that the government already knew about.” Id. Finally, the Seventh Circuit found 23 claims to be preempted when the plaintiff failed to present at trial any information that was either 24 a new analysis or data that had not been previously submitted to the FDA. Dolin v. 25 GlaxoSmithKline LLC, 901 F.3d 803, 816 (7th Cir. 2018), petition for cert. filed, 87 U.S.L.W. 26 3280 (Dec. 19, 2018) (No. 18-803). 27 28 i. Pre-2008 The CBE regulation was not amended to include the requirement that the labeling change 21 1 be based on “newly acquired information” until 2008. Levine, 555 U.S. at 568. Thus, as to the 2 three drugs approved prior to 2008 – Viread, Truvada, and Atripla – Gilead could have made a 3 labeling change via the CBE regulation regardless of whether the change presented “newly 4 acquired information.” Gilead does not dispute this and, on reply, argues only that the 2008 5 amendment requires “newly acquired information” as to post-approval failure-to-warn claims 6 regarding Stribild and Complera, which were approved after 2008. ECF No. 60 at 13 & n.7. 7 Plaintiffs’ pre-2008 claims as to Viread, Truvada, and Atripla are not preempted. United States District Court Northern District of California 8 ii. Post-2008 9 Regarding post-2008 claims, Gilead correctly notes that Plaintiffs allege that the company 10 knew that TDF posed risks to patients’ kidneys and bones before the first TDF drug was approved 11 by the FDA. For example, the complaint alleges that: 12 Before Gilead began selling its first TDF Drug, Viread, in 2001, Gilead knew that TDF posed a safety risk to patients’ kidneys and bones. Gilead knew that two of its other antiviral drugs with structures similar to tenofovir, cidofovir and adefovir dipivoxil, had been highly nephrotoxic (i.e., toxic to kidneys) and that preclinical data for TDF showed that it could cause significant kidney and bone damage. Gilead also knew that the relatively high dose of TDF created a greater risk of toxic effects, and that bone and kidney toxicities were even more likely to be seen with long-term use of TDF for the treatment of a virus that, for the foreseeable future, has no cure. 13 14 15 16 17 18 ECF No. 1 ¶ 5 (emphasis added); see also id. ¶ 210 (“Since scientists first synthesized TDF, 19 studies [including one published in 1999] have consistently shown that it could cause significant 20 kidney and bone damage.”). Similarly, Plaintiffs allege that: 21 Gilead knew years before it developed Stribild that: (a) higher tenofovir concentrations in patients’ blood, as opposed to the target cells, endangers the kidneys; (b) tenofovir concentrations in patients’ blood increase significantly when patients take tenofovir with a booster; and (c) TDF-associated renal toxicity occurs more frequently in patients taking TDF as part of a boosted regimen. 22 23 24 Id. ¶ 13. 25 However, the complaint also alleges that Gilead acquired additional information after FDA 26 approval. For example, Plaintiffs allege that Gilead became aware of “increasing post-approval 27 marketing evidence that patients with and without prior risk factors were experiencing kidney and 28 22 United States District Court Northern District of California 1 bone adverse effects, and expanding support within the scientific community to frequently monitor 2 multiple indicators of renal function in all patients.” Id. ¶ 363. Plaintiffs also allege that “Gilead’s 3 knowledge of the toxic effects of TDF only grew as patients began treatment with and were 4 injured by each successive TDF product. By the time Gilead designed Stribild, it had ten years’ 5 worth of cumulative evidence that TDF injured patients’ kidneys and bones.” Id. ¶ 6. Plaintiffs 6 further allege that, “less than one month after Viread entered the market, the first published case of 7 TDF-associated acute renal failure occurred. Thereafter, additional reports of TDF-associated 8 kidney damage, including but not limited to Fanconi syndrome, renal failure, renal tubular 9 dysfunction, and nephrogenic diabetes insipidus began to appear in the medical literature. Many 10 of those adverse events occurred in patients without preexisting kidney dysfunction.” Id. ¶ 214. 11 Additionally, Plaintiffs make the following allegations: “Gilead was also seeing renal adverse 12 events in its postmarketing safety data. In fact, the most common serious adverse events reported 13 to Gilead were renal events, including renal failure, Fanconi syndrome, and serum creatinine 14 increase,” id. ¶ 215 (footnotes omitted); “Gilead’s long-term clinical data also demonstrated that 15 TDF was damaging patients’ bones,” id. ¶ 218; and “[a]fter Gilead brought Truvada to market, the 16 medical literature continued to identify cases of TDF-associated kidney damage, including in 17 patients without pre-existing renal dysfunction or co-administration with another nephrotoxic 18 drug,” id. ¶ 219. Finally, Plaintiffs allege that various studies from 2006 to 2012 reported adverse 19 renal events in TDF patients and “continued to show that TDF caused a significant loss of renal 20 function in HIV-infected patients.” Id. ¶¶ 220-21, 226-28. 21 The problem with Plaintiffs’ allegations is that it is not possible to discern from the 22 complaint whether – and, if so, when – any such information was provided to the FDA. Plaintiffs 23 allege that the risks of TDF drugs were known before Gilead submitted its first TDF drug for 24 approval. It would be an unreasonable inference to conclude that Gilead did not present any 25 information concerning the risks of TDF drugs to the FDA, especially when Plaintiffs allege that 26 Gilead submitted multiple applications for different TDF drugs and that it also “update[d] its 27 Viread labeling at least four times [between 2002 and 2006] to describe the kidney damage 28 patients experienced when taking TDF,” id. ¶ 217, and again modified its labeling (as to 23 United States District Court Northern District of California 1 unspecified drugs) in 2007 and twice in 2008, id. ¶¶ 224-25. Such changes could not have been 2 made without application to the FDA for approval. See Levine, 555 U.S. at 568 (noting the 3 general rule that “a manufacturer may only change a drug label after the FDA approves a 4 supplemental application” before explaining that the CBE regulation provides that a manufacturer 5 may make certain changes “upon filing its supplemental application with the FDA”). Without 6 more, the Court cannot conclude that Plaintiffs have plausibly alleged the existence of “newly 7 acquired information” – i.e., “data, analyses, or other information not previously submitted to the 8 [FDA]” – such that it could have made post-2008 labeling changes under the CBE regulation. 21 9 C.F.R. § 341.3(b) (emphasis added). Consequently, Plaintiffs have not plausibly alleged that 10 Gilead could have made, under the CBE regulation or any other federal law allowing changes 11 without prior FDA approval, the post-2008 labeling changes Plaintiffs contend were required to 12 comply with state law.9 As pleaded, those claims are therefore preempted. The Court will grant 13 leave to amend because it is not clear that amendment could not cure the deficiencies identified in 14 this order. In short, as currently pleaded, Plaintiffs’ failure-to-warn claims are preempted as to post- 15 16 approval, post-2008 labeling changes. They are not preempted as to pre-approval labeling 17 changes or pre-2008 labeling changes to Viread, Truvada, or Atripla, the three TDF drugs that 18 were approved prior to 2008. 19 C. Adequacy of Causation Allegations in Failure-to-Warn Claims 20 Gilead argues that Plaintiffs have not adequately alleged causation on their failure-to-warn 21 claims. Plaintiffs do not dispute that they must allege that the allegedly inadequate warnings 22 caused them injury, or that the state laws they invoke require warnings to Plaintiffs’ physicians 23 and not to Plaintiffs directly. Instead, Plaintiffs argue that they “have alleged what Gilead says is 24 required – i.e., that but for Gilead’s warning failures, Plaintiffs’ physicians ‘would have acted 25 26 27 28 The Lujano court found sufficient the plaintiffs’ allegations that Gilead “should have viewed the accumulating evidence of the risks associated with Viread, Truvada and Atripla with respect to potential kidney damage, including Fanconi syndrome, and with respect to bone loss as requiring strengthened warning labels.” Lujano, at 5 (ECF No. 55-1 at 6). However, it did not discuss whether the “accumulating evidence” satisfied the definition of “newly acquired evidence,” including that it not have been previously submitted to the FDA. 24 9 1 United States District Court Northern District of California 2 differently.’” ECF No. 54 at 27 (quoting ECF No. 45 at 25). Gilead asserts that Plaintiffs must allege that their physicians would not have prescribed 3 the TDF drugs had Gilead given different warnings, but that position is not supported by the case 4 law. Although choosing not to prescribe a particular medication or device is one way that a 5 physician might have acted differently, it is not the only adequate means of demonstrating 6 causation on a failure-to-warn claim. To the contrary, as the first case cited by Gilead 7 demonstrates, the relevant question is whether the plaintiff’s physician would have “prescribed the 8 drug in the same manner.” Byrd v. Janssen Pharm., Inc., 333 F. Supp. 3d 111, 127 (N.D.N.Y. 9 2018) (emphasis added) (quoting Alston v. Caraco Pharm., Inc., 670 F. Supp. 2d 279, 285 10 (S.D.N.Y. 2009)). Thus, for example, courts have found triable issues of causation where 11 plaintiffs have presented evidence that their physicians would have used monitoring tests if 12 adequately warned to do so, or that they would have altered their prescription practices in a way 13 that may have prevented injury. In re Xarelto (Rivaroxaban) Prods. Liab. Litig., No. 2592, 2017 14 WL 1393480, at *2-3 (E.D. La. Apr. 17, 2017) (denying summary judgment where the plaintiff 15 presented evidence that her doctor “would have used [monitoring tests] had they been adequately 16 instructed to do so, and therefore . . . would have known [the plaintiff] was not anticoagulated and 17 would have proceeded with her surgery much sooner,” thus avoiding “significant medical issues”); 18 Georges v. Novartis Pharm. Corp., No. CV 06-5207 SJO (VBKx), 2012 WL 9083365, at *6 (C.D. 19 Cal. Nov. 2, 2012) (noting multiple courts have “held that even where physicians admitted that 20 they still recommended the Treatment Drugs knowing of their . . . risks [of causing deterioration 21 of bones in the jaw], the changes to their prescription and treatment procedure nonetheless created 22 triable questions of fact on specific causation”). Changed prescription practices might include 23 cautioning the patient about risk factors or reducing the prescribed dosage. Georges, 2012 WL 24 9083365, at *6. In addition, at least in some jurisdictions, causation can be demonstrated by 25 evidence that any of the plaintiff’s treating physicians would have acted differently with additional 26 knowledge, even if the prescribing physician would still have prescribed the drug with adequate 27 warnings. In re Aredia & Zometa Prods. Liab. Litig., No. 3:06-MD-1760, 2009 WL 2497692, at 28 *2 (M.D. Tenn. Aug. 13, 2009). 25 United States District Court Northern District of California 1 Plaintiffs’ causation allegations here are sufficient. First, Plaintiffs allege that their 2 physicians would have acted differently if Gilead’s warning labels had contained different 3 monitoring instructions: “Had Gilead adequately warned and instructed Plaintiffs’ doctors, 4 Plaintiffs’ doctors would have read and heeded such adequate warnings and instructions” and 5 “would have monitored Plaintiffs differently.” 10 ECF No. 1 ¶¶ 421-22, 493. Plaintiffs further 6 allege that increased monitoring “would have detected TDF toxicity earlier, thus preventing or 7 lessening Plaintiffs’ injuries.” Id. ¶ 422, 493; see also id. ¶¶ 339, 344 (Gilead’s “fail[ure] to warn 8 doctors to monitor all patients for TDF-associated toxicity” and “to monitor additional markers of 9 all patients’ kidney function . . . delayed the diagnosis of TDF-associated harm, causing or 10 enhancing injuries that would have been prevented or lessened through early detection.”). 11 Plaintiffs plausibly allege why “early detection is key to preventing serious, potentially 12 irreversible renal injury”: because “a patient experiences even greater exposure to tenofovir as the 13 kidneys become impaired – causing even greater harm. Frequent monitoring for TDF-induced 14 toxicity is also critical because patients are typically asymptomatic in the early stages.” Id. ¶ 324. 15 “Without using sufficiently sensitive markers of kidney function, substantial kidney injury can 16 occur before it is measurable. As a result, the detection of TDF-induced nephrotoxicity often 17 comes too late, resulting in kidney injury that may be irreversible.” Id. ¶ 341; see also id. ¶ 345 18 (“By the time a doctor assesses a patient’s kidney function when ‘clinically appropriate,’ the 19 patient is likely to have already experienced adverse toxic effects, some of which might be 20 irreversible. Regularly scheduled, frequent monitoring of kidney function is necessary to catch 21 early signs of TDF-induced toxicity and prevent injury because patients are generally 22 asymptomatic during the early stages.”). Plaintiffs further allege that “[f]requent monitoring of all 23 patients’ kidney function is necessary to ensure that patients’ kidneys are healthy enough to 24 continue treatment or patients receive a needed dose interval adjustment.” Id. ¶ 338. These 25 26 27 28 10 The Court recognizes a difference of opinion as to whether such allegations are sufficient to state a claim. For example, one court dismissed as “merely conclusory” an allegation that “had [the plaintiff’s] physician been adequately informed about the extensive dangers associated with the use of the Ventralex patch, his physician would not have implanted the device in Plaintiff.” Hammarlund v. C.R. Bard, Inc., No. 2:15-cv-05506-SVW-JEM, 2015 WL 5826780, at *5 (C.D. Cal. Oct. 2, 2015). The Court disagrees. 26 United States District Court Northern District of California 1 allegations are sufficient to allege a plausible causal link between Gilead’s alleged failure to warn 2 and Plaintiffs’ alleged injuries. To the extent Gilead argues the complaint is deficient because it 3 does not allege specific treatment that would have lessened Plaintiffs’ kidney and bone damage, 4 the Court disagrees; the contours of what Plaintiffs’ physicians might have done differently if 5 Gilead had provided different warnings can be explored during discovery. 6 D. Fraud and Consumer Protection Law Claims 7 Gilead moves to dismiss Plaintiffs’ fraud and consumer protection claims for failure to 8 comply with Rule 9(b)’s heightened pleading requirements. The rule applies to state-law fraud 9 claims, as well as to consumer protection claims that “sound in fraud” – i.e., that allege “a unified 10 course of fraudulent conduct and rely entirely on that course of conduct as the basis of that claim.” 11 Kearns v. Ford Motor Co., 567 F.3d 1120, 1125 (9th Cir. 2009). But where a plaintiff “choose[s] 12 not to allege a unified course of fraudulent conduct in support of a claim” and instead “allege[s] 13 some fraudulent and some non-fraudulent conduct . . . , only the allegations of fraud are subject to 14 Rule 9(b)’s heightened pleading requirements.” Vess, 317 F.3d at 1104. “The rule does not 15 require that allegations supporting a claim be stated with particularity when those allegations 16 describe non-fraudulent conduct.” Id. The Court agrees with Plaintiffs that not all of their claims sound in fraud. For example, 17 18 Plaintiffs allege that “Gilead knowingly designed unreasonably dangerous TDF Drugs that injured 19 Plaintiffs to make more money – conduct which is ‘unfair’ under the laws of numerous states.” 20 ECF No. 54 at 29 (citations omitted). Gilead does not argue that such conduct would not be 21 “unfair,” but it argues that Rule 9(b) nonetheless applies because the alleged conduct is part of a 22 unified course of fraudulent conduct.11 However, whether Gilead acted unfairly by designing 23 unreasonably dangerous drugs for financial gain does not require that Gilead also acted 24 fraudulently. Cf. Haskins v. Symantec Corp., No. 13-cv-01834-JST, 2013 WL 6234610, at *8 25 (N.D. Cal. Dec. 2, 2013) (“The Court does not agree that Plaintiff’s claims under the [‘unfair 26 27 28 11 As with the design-defect and failure-to-warn claims, the parties do not present argument on the specific requirements under state law. For purposes of this motion, the Court assumes without deciding that Plaintiffs are correct that the alleged conduct would be considered “unfair” under various state laws. 27 1 practices’ and ‘fraudulent practices’] prongs are coterminous; she also appears to argue that it was 2 unfair practice for Defendant to sell a product it knew to be compromised, regardless of the 3 content of its advertisements.”). Rule 9(b) therefore does not apply to these claims. 4 Rule 9(b) does, however, govern Plaintiffs’ fraud claims and their consumer protection 5 claims to the extent that the latter allege a course of fraudulent conduct. Plaintiffs contend that 6 their claims are based only on omissions and not affirmative misrepresentations, but Gilead 7 correctly observes that the complaint also alleges misrepresentations. For example, in the count 8 alleging violation of consumer protection laws, Plaintiffs allege that: 9 10 United States District Court Northern District of California 11 12 13 14 15 16 17 Gilead intentionally misrepresented material facts in its promotional, marketing, and labeling communications about the risks and benefits of the TDF Drugs to Plaintiffs and Plaintiffs’ doctors, including but not limited to, that the TDF Drugs: 1) presented limited risk of kidney and bone toxicity resulting from purportedly unavoidable side effects of tenofovir; and 2) did not require careful, frequent monitoring of all TDF Drug patients for TDF-associated kidney and bone toxicity. ECF No. 1 ¶ 536 (emphasis added); see also id. ¶¶ 539-43 (referring to “misrepresentations” as well as “omissions”). Plaintiffs elsewhere allege that Gilead “misrepresent[ed] the safety profile of TDF when promoting TDF to doctors” and gave “misleading marketing messages” to doctors, including “that Viread was a ‘miracle drug,’ ‘extremely safe,’ and ‘extremely well-tolerated’ with ‘no toxicities.’” Id. ¶¶ 327, 333. Similarly, Plaintiffs allege that Gilead “misrepresent[ed]: (a) that 18 any tenofovir-induced toxicity was rare and unavoidable; (b) why Gilead had purportedly 19 20 21 abandoned development of TAF in 2004; and (c) that TAF was ‘new’ once Gilead finally introduced the safer TAF design over a decade later.” Id. ¶ 511; see also id. ¶ 332 (alleging that “Gilead continued to downplay the risks of TDF-induced toxicity when promoting its TDF Drugs 22 to doctors by misrepresenting the drug as safe, dismissing case reports of acute renal failure and 23 other TDF-associated adverse events as purportedly unavoidable side effects of tenofovir in an 24 25 26 27 otherwise ‘safe’ drug, and discouraging doctors from monitoring patients for drug-induced toxicity using more sensitive markers of kidney function”). Even Plaintiffs’ opposition brief argues that “Plaintiffs’ fraud by omission and consumer protection claims . . . are based, in part, on Gilead’s omissions and misrepresentations with respect to TDF and TAF.” ECF No. 54 at 26- 28 28 1 27 (emphasis added). Thus, at least as currently pleaded, Plaintiffs’ claims are not only about 2 omissions, and Plaintiffs may not rely on the lower level of specificity allowed for claims based on 3 alleged omissions to avoid dismissal of their misrepresentation claims. Plaintiffs do not argue that 4 they have satisfied Rule 9(b) as to those claims, and the Court will therefore dismiss those claims 5 with leave to amend. 6 7 Ford Motor Co., 37 F. Supp. 3d 1087 (N.D. Cal. 2014), this Court considered allegations that Ford 8 failed to disclose a coolant pump defect to consumers. Ford argued in its motion to dismiss that 9 the plaintiffs failed to plead omission with particularity. The Court disagreed and concluded that: 10 Plaintiffs adequately allege the “who what when and how,” given the inherent limitations of an omission claim. In short, the “who” is Ford, the “what” is its knowledge of a defect, the “when” is prior to the sale of Class Vehicles, and the “where” is the various channels of information through which Ford sold Class Vehicles. 11 United States District Court Northern District of California However, Plaintiffs’ omissions-based claims are sufficiently pleaded. In MacDonald v. 12 13 Id. at 1096. Likewise, here, as Plaintiffs observe in their opposition: “The ‘who’ is Gilead, the 14 ‘what’ is an adequate warning about the risks and safe use of TDF and the fact that Gilead was 15 withholding safer designs of the TDF Drugs, the ‘when’ is prior to Plaintiffs’ doctors’ prescribing 16 and monitoring decisions, and the ‘where’ is in Gilead’s drug labeling, marketing, and 17 promotional materials.” ECF No. 54 at 31. For example, the complaint alleges: 18 19 20 21 22 23 24 25 Gilead intentionally suppressed, concealed, and omitted material facts in its promotional, marketing, and labeling communications about the risks and benefits of the TDF Drugs to Plaintiffs and Plaintiffs’ doctors, including but not limited to, that: 1) all TDF patients should be carefully and frequently monitored for adverse kidney and bone effects on a frequent schedule; 2) Gilead had already developed the safer TAF design for delivering tenofovir into the body but nevertheless designed the TDF Drugs to contain TDF, and withheld the safer [TAF] design, in order to maximize profits on its TDF-based products and extend its ability to profit on its HIV franchise for years to come; and 3) Gilead knew that the tenofovir prodrug dose should be reduced when combined in a fixed dose combination pill with cobicistat, but did not reduce the TDF dose in Stribild. ECF No. 1 ¶ 535; see also id. ¶ 507 (“Gilead intentionally omitted from its prescriber and patient 26 labeling an adequate warning regarding the need for doctors to monitor all TDF patients, on a 27 frequent, specific schedule, for the adverse effects of TDF-associated bone and kidney toxicity.”). 28 29 United States District Court Northern District of California 1 The complaint is “specific enough” as to omissions “to give defendants notice of the particular 2 misconduct so that they can defend against the charge and not just deny that they have done 3 anything wrong.” Vess, 317 F.3d at 1106 (internal quotation marks and alteration omitted). 4 Plaintiffs’ claims based on omissions are therefore not subject to dismissal under Rule 9(b). 5 The Court denies Gilead’s alternate request to require Plaintiffs to submit a more definite 6 statement under Federal Rule of Civil Procedure 12(e). First, Gilead’s moving papers made this 7 argument only in a footnote. ECF No. 45 at 30 n.15. “Arguments raised only in footnotes, or only 8 on reply, are generally deemed waived” and need not be considered. Estate of Saunders v. 9 Comm’r, 745 F.3d 953, 962 n.8 (9th Cir. 2014); see Sanders v. Sodexo, Inc., No. 2:15-cv-00371- 10 JAD-GWF, 2015 WL 4477697, at *5 (D. Nev. July 20, 2015) (“Many courts will disregard 11 arguments raised exclusively in footnotes.” (quoting Bryan Garner, The Redbook: A Manual on 12 Legal Style 168 (3d ed.2013))). Moreover, on the merits, the Court does not find the complaint to 13 be “so vague or ambiguous that [Gilead] cannot reasonably prepare a response.” Fed. R. Civ. 14 P. 12(e). CONCLUSION 15 Gilead’s motion to dismiss is granted in part and denied in part. The motion is granted as 16 17 to Plaintiffs’ failure-to-warn claims based on post-approval, post-2008 labeling changes, and as to 18 Plaintiffs’ fraud and consumer protection claims to the extent those claims are based on 19 misrepresentations and not omissions. Plaintiffs are granted leave to amend the dismissed claims. 20 The motion is denied in all other respects. 21 As confirmed at the April 23, 2019 case management conference, the parties have agreed 22 that Plaintiffs can amend the complaint “to allege consumer protection claims for damages under 23 the state consumer protection laws of Alabama, California, Indiana, and Texas.” ECF No. 59 at 5; 24 ECF No. 62. Plaintiffs should also consider whether to incorporate the Dowdy plaintiffs’ claims 25 into the amended complaint, such that there is a single consolidated complaint for these cases. 26 /// 27 /// 28 /// 30 1 2 3 4 5 6 Any amended complaint must be filed on or before May 31, 2019. Failure to file a timely amended complaint will result in dismissal with prejudice of the claims dismissed by this order. IT IS SO ORDERED. Dated: May 10, 2019 ______________________________________ JON S. TIGAR United States District Judge 7 8 9 10 United States District Court Northern District of California 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 31

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