1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 JOHN AUSTIN, Case No. 3:21-cv-10069-JD

8 Plaintiff,

ORDER RE MOTION TO DISMISS

v. 9

10 BOEHRINGER INGELHEIM

PHARMACEUTICAL INC.,

11 Defendant.

12 13 This case involves a prescription anticoagulant medication, Pradaxa (dabigatran). Pro se 14 plaintiff John Austin’s wife, Lisa Austin, was prescribed Pradaxa, took it, and later developed 15 interstitial lung disease and died. Dkt. No. 42 at 2. Defendant Boehringer Ingelheim 16 Pharmaceuticals, Inc. (BIPI) is “responsible for the drug [Pradaxa] in the United States.” Dkt. No. 17 46 at 1. Austin alleges that BIPI’s label for Pradaxa “does not warn of the association with” 18 interstitial lung disease, and that BIPI “was obligated to give such warning under FDA rules and 19 California law.” Dkt. No. 42 at 3. BIPI asks to dismiss Austin’s second amended complaint 20 (SAC). Dkt. No. 46. The parties’ familiarity with the record is assumed, and dismissal is denied. 21 LEGAL STANDARDS 22 The standards for a motion to dismiss under Rule 12(b)(6) are well-established. The 23 Court’s prior statements of the standards are incorporated here. See Duque v. Permanente Med. 24 Grp., No. 18-cv-03356-JD, 2019 WL 13254072, at *2 (N.D. Cal. July 1, 2019); Hostetler v. 25 Wormuth, No. 22-cv-03605-JD, 2023 WL 2959994, at *1 (N.D. Cal. Apr. 14, 2023). In pertinent 26 part, a claim must provide “a short and plain statement . . . showing that the pleader is entitled to 27 relief,” Fed. R. Civ. P. 8(a)(2), including “enough facts to state a claim . . . that is plausible on its 1 accepting all the factual allegations as true and construing them in the light most favorable to the 2 plaintiff, the Court can reasonably infer that the defendant is liable for the misconduct alleged. 3 See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). The Court will not treat as fact or accept as true 4 allegations that are bare legal conclusions, recitations of elements, or unwarranted deductions. See 5 id.; see also In re Gilead Scis. Sec. Litig., 536 F.3d 1049, 1055 (9th Cir. 2008). The plausibility 6 analysis is “context-specific” and not only invites but “requires the reviewing court to draw on its 7 judicial experience and common sense.” Iqbal, 556 U.S. at 679. The Court has a “duty ‘to 8 construe pro se pleadings liberally, including pro se motions as well as complaints.’” Choudhuri 9 v. Specialized Loan Servicing, No. 19-cv-04198-JD, 2019 WL 3323088, at *1 (N.D. Cal. July 24, 10 2019) (quoting Bernhardt v. Los Angeles Cnty., 339 F.3d 920, 925 (9th Cir. 2003)). 11 DISCUSSION 12 I. TIMELINESS 13 BIPI suggests that Austin’s claims are barred by California’s two-year statute of 14 limitations for personal injury and wrongful death actions. Dkt. No. 46 at 3-4 (citing Cal. Code 15 Civ. Proc. § 335.1). BIPI says that (1) Austin’s claims accrued on November 2, 2018, the day his 16 wife passed away; (2) Austin filed his original complaint in state court on November 2, 2020, but 17 named Boehringer Ingelheim Corporation (BIC) as a defendant and not BIPI; (3) BIPI was named 18 as a defendant in the first amended complaint that was filed on May 23, 2022, but it was never 19 served with that complaint; and (4) BIPI was served with the SAC on January 23, 2023, “over four 20 years after [Austin’s] claims accrued.” Id. at 4. BIPI contends that Austin’s claims against it 21 cannot be related back to the filing of his original complaint because no defendant was served with 22 that complaint within the 90-day period contemplated by Federal Rule of Civil Procedure 4(m). 23 See Fed. R. Civ. P. 15(c)(1)(C) (“An amendment to a pleading relates back to the date of the 24 original pleading when . . . the amendment changes the party or the naming of the party against 25 whom a claim is asserted, if . . . within the period provided by Rule 4(m) for serving the summons 26 and complaint, the party to be brought in by amendment . . . received such notice of the action that 27 it will not be prejudiced in defending on the merits . . . .”). 1 The point is not well taken. It is true that the “title of the complaint must name all the 2 parties.” Fed. R. Civ. P. 10(a). But the caption of the complaint is not necessarily determinative 3 as to the identity of the parties. See United States ex rel. Eisenstein v. City of New York, 556 U.S. 4 928, 935 (2009) (citing 5A C. Wright & A. Miller, Federal Practice and Procedure § 1321, p. 388 5 (3d ed. 2004) (“[T]he caption is not determinative as to the identity of the parties to the action.”)). 6 And Rule 8(e) requires that “[p]leadings must be construed so as to do justice.” Fed. R. Civ. P. 7 8(e). In this case, the caption of Austin’s original complaint listed “Boehringer Ingelheim, a 8 corporation” as a defendant. Dkt. No. 1-5 at ECF p. 3. The second paragraph of the complaint 9 explicitly refers to “Defendant Boehringer Ingelheim Pharmaceuticals, Inc.,” id. at ECF p. 4, and 10 nowhere does the complaint mention BIC. In moving to dismiss the original complaint, BIC 11 recognized that Austin “directed his allegations to BIPI.” Dkt. No. 7 at 1. BIPI says that only BIC 12 was served with the complaint, but the record is unclear about the circumstances surrounding 13 service.1 Under these circumstances, and given that BIPI, which is represented here by the same 14 counsel as BIC, will experience little if any prejudice, the Court declines to dismiss Austin’s suit 15 on timeliness grounds. 16 II. DUTY TO WARN 17 BIPI says that it had no duty to warn of an association between Pradaxa use and interstitial 18 lung disease. See Dkt. No. 46 at 8. “Under California law, drug manufacturers have a duty to 19 warn physicians of risks that are known or scientifically knowable at the time of the drug’s 20 distribution.” Wendell v. GlaxoSmithKline LLC, 858 F.3d 1227, 1238 (9th Cir. 2017). “The 21 manufacturer has no duty to warn of risks that are ‘merely speculative or conjectural, or so remote 22 and insignificant as to be negligible.’” T.H. v. Novartis Pharmaceuticals Corp., 4 Cal. 5th 145, 23 164 (2017) (quoting Carlin v. Superior Court, 13 Cal. 4th 1104, 1116 (1996)). “If the 24 25

26 1 “Boehringer Ingelheim” is the name of the party that was served, according to the records of the San Francisco Superior Court. See Proof of Service as to Defendant Boehringer Ingelheim, a 27 Corporation, filed in Austin v. Boehringer Ingelheim, No. CGC-20-587448 (S.F. Super. Ct. Dec. 7, 1 manufacturer provides an adequate warning to the prescribing physician, the manufacturer need 2 not communicate a warning directly to the patient who uses the drug.” Id. 3 The complaint plausibly alleges that BIPI had a duty to warn. Austin says that BIPI “knew 4 or should have known that their product was associated with and or a causal factor in [interstitial 5 lung disease] and they failed to warn consumers and medical personal [sic] of that information.” 6 Dkt. No. 42 at 3. Austin cites and attaches a case report that notes that in 2011, “the Ministry of 7 Health, Labour and Welfare of Japan issued an alert that dabigatran administration might be 8 associated with interstitial lung diseases, including death in cases with preexisting interstitial 9 pneumonia.” Id. at ECF p. 7. The report discusses a case where a “patient’s interstitial 10 pneumonia was diagnosed to be a drug-induced lung injury caused by dabigatran.” Id. at ECF p. 11 5. BIPI objects that the case report “cannot plausibly create the foundation for a lawsuit alleging 12 that BIPI had an affirmative duty to warn of the hypothetical risk,” but relies principally on cases 13 that were decided at summary judgment, on more developed factual records. Dkt. No. 46 at 8-9 14 (citing, for example, Wendell v. SmithKline Beecham, No. 09-cv-04124-CW, 2018 WL 6267855, 15 at *5 (N.D. Cal. Aug. 15, 2018); Salinas v. City of San Jose, No. 09-cv-04410-EJD, 2013 WL 16 2450114, at *6 (N.D. Cal. June 5, 2013)). At this early pleadings stage, the allegations are enough 17 to go forward with an eye towards revisiting the question on a fully developed record. 18 III. FEDERAL PREEMPTION 19 BIPI says that Austin’s failure-to-warn claim is impliedly preempted by federal law. See 20 Dkt. No. 46 at 10. “Even in the absence of an express pre-emption provision, the [Supreme] Court 21 has found state law to be impliedly pre-empted where it is ‘impossible for a private party to 22 comply with both state and federal requirements.’” Mut. Pharm. Co., Inc. v. Bartlett, 570 U.S. 23 472, 480 (2013) (quoting English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990)). “The question for 24 ‘impossibility’ is whether the private party could independently do under federal law what state 25 law requires of it.” PLIVA, Inc. v. Mensing, 564 U.S. 604, 620 (2011). This form of federal 26 preemption, known as impossibility preemption, “is a demanding defense.” Wyeth v. Levine, 555 27 U.S. 555, 573 (2009). 1 The Food and Drug Administration (FDA), acting pursuant to its authority under the 2 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (FDCA), “regulates the safety 3 information that appears on the labels of prescription drugs that are marketed in the United 4 States.” Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1672 (2019). “FDA 5 regulations set out requirements for the content, the format, and the order of the safety information 6 on the drug label.” Id. at 1673. “Prospective drug manufacturers work with the FDA to develop 7 an appropriate label when they apply for FDA approval of a new drug.” Id. “But FDA 8 regulations also acknowledge that information about drug safety may change over time, and that 9 new information may require changes to the drug label.” Id. (citing 21 C.F.R. §§ 314.80(c), 10 314.81(b)(2)(i)). “Drug manufacturers generally seek advance permission from the FDA to make 11 substantive changes to their drug labels.” Id. “However, an FDA regulation called the ‘changes 12 being effected’ or ‘CBE’ regulation permits drug manufacturers to change a label without prior 13 FDA approval if the change is designed to ‘add or strengthen a . . . warning’ where there is ‘newly 14 acquired information’ about the ‘evidence of a causal association’ between the drug and a risk of 15 harm.” Id. (quoting 21 C.F.R. § 314.70(c)(6)(iii)(A)). FDA regulations provide that “the labeling 16 must be revised to include a warning about a clinically significant hazard as soon as there is 17 reasonable evidence of a causal association with a drug; a causal relationship need not have been 18 definitively established.” 21 C.F.R. § 201.57(c)(6)(i). 19 The CBE regulation allows brand-name manufacturers to provide the warnings required by 20 state law before receiving FDA approval, which can undercut an impossibility preemption 21 defense. See Levine, 555 U.S. at 571. But “the FDA retains authority to reject labeling changes 22 made pursuant to the CBE regulation.” Id. Consequently, the Supreme Court has held that “state 23 law failure-to-warn claims are pre-empted by the [FDCA] and related labeling regulations when 24 there is ‘clear evidence’ that the FDA would not have approved the warning that state law 25 requires.” Albrecht, 139 S. Ct. at 1676 (quoting Levine, 555 U.S. at 571). 26 The application of these principles here is subject to the additional consideration of the 27 pleadings motion at hand. Federal preemption is an affirmative defense. “An affirmative defense 1 is, admits all the ingredients of an impenetrable defense.’” Boquist v. Courtney, 32 F.4th 764, 774 2 (9th Cir. 2022) (quoting Durnford v. MusclePharm Corp., 907 F.3d 595, 603 n.8 (9th Cir. 2018)). 3 BIPI suggests that Austin “must plead a labeling deficiency that [it] could have corrected 4 || using the CBE regulation,” Dkt. No. 46 at 10 (internal quotations, citation, and emphasis omitted), 5 and faults Austin for not coming forward with sufficient evidence of a causal association between 6 || Pradaxa and interstitial lung disease, see Dkt. No. 49 at 5-6. A handful of other circuits appear to 7 have adopted the threshold pleading requirement that BIPI proposes. See, e.g., Gibbons v. Bristol- 8 || Myers Squibb Co., 919 F.3d 699, 708 (2d Cir. 2019) (“[T]o state a claim for failure-to-warn [based 9 on post-drug-release information] that is not preempted by the FDCA, a plaintiff must plead a 10 || labeling deficiency that [the defendant] could have corrected using the CBE regulation.”) (internal 11 quotations and citation omitted). 12 BIPI’s preemption argument raises factual issues that are better suited for resolution on a 13 fully developed record. It is declined for that reason under Rule 12(b)(6). It also bears mention 14 || that the Ninth Circuit has not adopted the approach taken by other courts, and a good argument 3 15 can be made that such an approach cannot be readily reconciled with our rules on the treatment of a 16 affirmative defenses at the motion to dismiss stage.

CONCLUSION

18 BIPI’s motion to dismiss is denied. The parties are directed to meet and confer on a 19 || proposed amended scheduling order that allows adequate time for discovery and trial preparation. 20 || They are directed to jointly file their proposed schedule by June 2, 2023. 21 Austin may wish to consult with the District’s Legal Help Center. Lawyers at the Center 22 || can provide basic assistance to parties representing themselves, but not legal representation. 23 Appointments can be made by calling (415) 782-8982 or emailing fedpro@ sfbar.org. 24 IT IS SO ORDERED. 25 || Dated: May 12, 2023 26 27

JAMES#PPONATO

28 United Btates District Judge