Streed et al V Wyeth Pharmaceuticals, Inc. et Al.,

MOTION to Dismiss for Lack of Jurisdiction

N.D. Cal.June 15, 2017

1110608v.2 Roberto M. Alonso Olmo (SBN 300986) Morrison Mahoney LLP 120 Broadway, Suite 1010 New York, NY 10271 ralonso@morrisonmahoney.com Counsel for Defendants Zydus Pharmaceuticals USA, Inc. and Taro Pharmaceuticals USA, Inc. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA EDWIN STREED, et al., Plaintiffs, -against- WYETH PHARMACEUTICALS, INC., SANDOZ, INC., EON LABS, INC., TEVA PHARMACEUTICALS USA, INC., PAR PHARMACEUTICALS COMPANIES, INC., ZYDUS PHARMACEUTICALS USA, INC., TARO PHARMACEUTICALS USA, INC., UPSHER-SMITH PHARMACEUTICALS, INC., BARR PHARMACEUTICALS INC., McKESSON CORPORATION; and DOES 1-50, Inclusive, Defendants. Case No. 3:17-CV-02609 DEFENDANTS ZYDUS PHARMACEUTICALS USA, INC.’S and TARO PHARMACEUTICALS USA, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT Date: July 19, 2017 Time: 2:00 p.m. Judge: TBD Courtroom: TBD Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 1 of 30 i 1110608v.2 TABLE OF CONTENTS NOTICE OF MOTION AND MOTION TO DISMISS ................................................................. 1 MEMORANDUM OF POINTS AND AUTHORITIES ................................................................ 2 PRELIMINARY STATEMENT .................................................................................................... 2 STATEMENT OF FACTS ............................................................................................................. 5 ARGUMENTS................................................................................................................................ 8 CONCLUSION............................................................................................................................. 25 TABLE OF AUTHORITIES Page(s) CASES Anderson v. Medtronic, Inc., 2015 WL 2115342 (S.D. Cal. May 6, 2015)............................................................................17 Ashcroft v. Iqbal, 556 U.S. 662 (2009).......................................................................................................4, 20, 21 Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007).............................................................................................................4, 20 Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).............................................................................................................5, 19 Burger King Corp. v. Rudzewicz, 471 U.S. 462 (1985).................................................................................................................12 Connolly v. Sandoz Pharms. Corp., No. 2:14-cv-152-WCO (N.D. Ga. December 23, 2014)..........................................................19 Cooper v. Equity General Ins., 219 Cal.App.3d 1252 (1990)....................................................................................................23 Daimler AG v. Bauman, 571 U.S. __, 134 S. Ct. 746 (2014)..................................................................................2, 9, 10 Dreher v. Wyeth Pharmaceuticals, Inc., 2015 WL 3948961 (N.D. Ala. Jun. 29, 2015) ..........................................................................19 Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 2 of 30 ii 1110608v.2 Dunbar v. Medtronic, Inc., No. CV 14-01529-RGK, 2014 WL 3056026 (C.D. Cal. June 25, 2014).................................17 Elliott v. Sandoz Inc., 2016 WL 4398407 (N.D. Ala. Aug. 18, 2016) ..................................................................15, 18 Frere v. Medtronic, Inc., No. 15-2338, 2016 WL 1533524 (C.D. Cal. Apr. 6, 2016) ....................................................14 Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011).......................................................................................................9, 10, 11 Houston v. Medtronic, 957 F.Supp.2d 1166 (C.D. Cal. 2013)...............................................................................14, 17 In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., No. 05-1699 CRB, 2006 WL 2374742 (N.D. Cal. Aug. 16, 2006) ........................................14 Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC, 2014 WL 819392 (C.D. Cal. Feb. 14, 2014) ..............................14 Kearns v. Ford Motor Co., 567 F.3d 1120 (9th Cir. 2009) ..................................................................................................23 Ko v. Mutual Pharm. Co., Inc., 2013 WL 5692375, No. C13-0890-RMW (N.D. Cal. Oct. 18, 2013) .....................................14 Lashley v. Pfizer, Inc. 750 F.3d 470 (5th Cir. 2014) ....................................................................................................15 Lazar v. Super. Ct., 12 Cal. 4th 631 (1996)..............................................................................................................23 Lukovsky v. City & Cnty of S.F., 535 F.3d 1044 (9th Cir. 2008) ..................................................................................................24 Moretti v. Wyeth, 579 F. App’x. 563 (9th Cir. 2014) ...........................................................................................14 Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013) ....................................................................................................15 Mutual Pharm. Co. v. Bartlett, 133 S.Ct. 2466 (2013)..............................................................................................3, 13, 14, 18 Pebble Beach Co. v. Caddy, 453 F.3d 1151 (9th Cir. 2006) ...................................................................................................9 Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 3 of 30 iii 1110608v.2 Perdue v. Wyeth Pharmaceuticals, Inc., 209 F.Supp.3d 847 (E.D.N.C., July 20, 2016).............................................................15, 18, 19 PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011)..........................................................................................................4, 15 Ranza v. Nike, Inc., 793 F.3d 1059 (9th Cir. 2015) ...................................................................................................9 Rusk v. Wyeth-Ayerherst Laboratories, Inc., 2015 WL 3651434 (W.D. Tex. June 11, 2015) ...........................................................15, 19, 22 Stansfield v. Starkey, 220 Cal.App.3d 59 (1990)........................................................................................................23 Stephens v. Teva Pharm. Inc., et al., 70 F. Supp. 3d 1246, 1254 (N.D. Ala. 2014).....................................................................15, 22 Swartz v. KPMG LLP, 476 F.3d 756 (9th Cir. 2007) ....................................................................................................24 Williams v. Yamaha Motor Co., 851 F.3d 1015 (9th Cir. 2017) ............................................................................................10, 11 STATUTES 21 U.S.C. §§ 331(d), 352(f), and 355 ............................................................................................17 21 U.S.C. §337(a) ..............................................................................................................16, 17, 18 21 U.S.C. § 355(j)(2)(A)................................................................................................................13 A.R.S. §§ 12-551, 12-542 ..............................................................................................................25 Ala. Stat §6-2-38............................................................................................................................25 Cal. Code Civ. Proc. §335.1, 340.8(a) ...........................................................................................25 Cal. Code Civ. Proc. § 410.10 .........................................................................................................9 Ky. Rev. Stat. §413.140(1)(a) ........................................................................................................25 MCLA §600.5805(13) ...................................................................................................................25 O.C.G.A. §9-3-33...........................................................................................................................25 Ohio Rev. Code Ann. §2305.10(A) ...............................................................................................25 S.C. Code Ann. §15-3-530, 15-3-535 ............................................................................................25 Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 4 of 30 iv 1110608v.2 42 Pa. Consol. Stat. §5524(2) ........................................................................................................25 Tenn. Code Ann. §28-3-104 ..........................................................................................................25 Tex. Civ. Prac. & Rem. Code Ann. §16.003 .................................................................................25 OTHER AUTHORITIES 21 C.F.R. §208.24 ..........................................................................................................................22 21 C.F.R. §208.24(b) .....................................................................................................................18 21 CFR §208.24(c).................................................................................................................4, 7, 19 21 CFR §208.24(e).......................................................................................................................4, 7 21 CFR §208.1 .................................................................................................................................7 Fed. R. Civ. P. 8(a)(2)......................................................................................................2, 4, 20, 21 Fed. R. Civ. P. 9(b) ....................................................................................................2, 4, 22, 23, 24 Fed. R. Civ. P. 12(b)(2)................................................................................................................1, 3 Fed. R. Civ. P. 12(b)(6)......................................................................................................1, 2, 5, 23 Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 5 of 30 1 1110608v.2 NOTICE OF MOTION AND MOTION TO DISMISS PLEASE TAKE NOTICE that on July 19, 2017, at 2:00 p.m., or as soon thereafter as the matter may be heard before the Assigned Judge (to be determined) in the United States District Court for the Northern District of California, San Francisco Courthouse, located at 450 Golden Gate Avenue, San Francisco, California, Defendants Zydus Pharmaceuticals USA, Inc. (“Zydus”) and Taro Pharmaceuticals USA, Inc. (“Taro”) will and hereby do move the court to dismiss Plaintiffs’ First Amended Complaint against Zydus and Taro pursuant to Rule 12(b)(2) and 12(b)(6) of the Federal Rules of Civil Procedure. This motion is filed in accordance with the Stipulation and Proposed Order agreed upon by plaintiffs, Zydus, and Taro. [See, Doc. 61]. Zydus and Taro move to dismiss the Plaintiffs’ First Amended Complaint (“Amended Complaint”) on the grounds that (1) the court lacks personal jurisdiction over Zydus and Taro for actions involving non-California resident plaintiffs and involving plaintiffs who do not allege injury from use of a Zydus or Taro product, and (2) the Amended Complaint fails to state any cause of action upon which relief may be granted. This Court should dismiss plaintiffs’ Amended Complaint because (1) plaintiffs’ cannot establish general or specific jurisdiction over Zydus or Taro; (2) plaintiffs’ actions are preempted by federal law; and (3) plaintiffs’ complaints are defectively and deficiently pled under Federal Rules of Civil Procedure, Rules 8(a) and 9(b), and thus fail to state a claim upon which relief may be granted; and (4) plaintiffs’ alleged time-barred causes of action are precluded by the applicable state statute of limitations. This motion is based upon this Notice of Motion to Dismiss and the accompanying Memorandum of Points and Authorities in support the pleadings and the argument of counsel at the time of any hearing, and any further and additional evidence and argument as may be presented at or before the time of hearing on this motion. Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 6 of 30 2 1110608v.2 MEMORANDUM OF POINTS AND AUTHORITIES PRELIMINARY STATEMENT Defendants Zydus Pharmaceuticals USA, Inc. (“Zydus”) and Taro Pharmaceuticals USA, Inc. (“Taro”), submits this memorandum of law in support of their respective motions to dismiss Plaintiff's’ First Amended Complaint (“FAC” or “Amended Complaint”) for lack of personal jurisdiction pursuant to the Federal Rules of Civil Procedure (“Fed. R. Civ. P.”) 12(b)(2), for failure to state a claim pursuant to Fed. R. Civ. P. 12(b)(6), and for failure to allege necessary facts in satisfaction of the federal pleading requirements under Fed. R. Civ. P. 8(a)(2) and 9(b). This Court lacks personal jurisdiction over Zydus and Taro. Zydus is a New Jersey corporation with its principal place of business in Pennington, Pennsylvania. Plaintiffs’ amended complaint incorrectly identifies Zydus as a Pennsylvania corporation. (FAC ¶ 45). Taro is a New York corporation with its principal place of business in Hawthorne, New York. Plaintiffs’ amended complaint incorrectly identifies Taro’s principal place of business as New York, New York. (FAC ¶ 46). Neither Zydus nor Taro are incorporated in, nor do they respectively have, a principal place of business in California. There are a total of 56 plaintiffs in the Amended Complaint who are non-residents of California and reside outside the state of California, had their “amiodarone” prescriptions filled outside the state of California, and allegedly sustained an injury as a result of the product outside of the state of California. These actions have no factual connection with the state of California. Moreover, 54 of the non-resident plaintiffs do not even specifically allege that Zydus or Taro’s product caused their injury, and the six resident plaintiffs have not specifically alleged that they purchased, ingested or was injured by Zydus and/or Taro’s amiodarone product. As a result, there is no basis for general jurisdiction since Zydus and Taro are foreign corporations, and who are not “at home” in California. See, Daimler AG v. Bauman, 571 U.S. __, 134 S. Ct. 746, 761 (2014). In addition, this Court does not have specific jurisdiction Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 7 of 30 3 1110608v.2 over either Zydus or Taro because the non-resident plaintiffs’ allegations and injuries have no connection whatsoever to the State of California. Given that none of the plaintiffs specifically allege that Zydus or Taro caused their injury, there is nothing linking their lawsuit to the actions by Zydus and Taro in California. Therefore, the court should dismiss plaintiffs’ claims against Zydus and Taro pursuant to Fed. R. Civ. P. 12(b)(2). A total of sixty-two plaintiffs and/or decedents (collectively referred to herein as “plaintiffs”) have alleged various personal injuries and loss of consortium suffered as a result of their use of amiodarone, a generic prescription medication that plaintiffs were prescribed to treat atrial fibrillation. Plaintiffs have alleged that the warnings accompanying Zydus’ and Taro’s generic drug product were inadequate because they failed to contain additional or stronger warnings regarding the risks associated with the product. Zydus and Taro contend that plaintiffs’ action based on a purported failure to warn must be dismissed as pre-empted by federal law. The United States Supreme Court has held in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011) and Mutual Pharm. Co. v. Bartlett, 133 S.Ct. 2466 (2013) that challenges to the adequacy of generic drug warnings are pre-empted by federal law since generic drug manufacturers are required to match their warnings to those of the brand-name counterparts and generic manufacturers cannot unilaterally add or change their product warnings without prior approval from the Food and Drug Administration (“FDA”). In an attempt to circumvent express federal pre-emption, plaintiffs contend in this action that Zydus and Taro fraudulently promoted amiodarone for off-label use and distributed the product to distributors and pharmacies without an FDA-required medication guide. However, plaintiffs’ allegations of off-label promotion falls within the ambit of a cause of action for failure to warn and equally fails on federal pre-emption grounds. Moreover, the causes of action should Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 8 of 30 4 1110608v.2 be dismissed in accord with the United States Supreme Court decision in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), in which the Supreme Court held that a private litigant's assertion of a cause of action for alleged violations of the Food, Drug and Cosmetic Act (“FDCA”) and FDA regulations are impliedly pre-empted by federal law. Since plaintiffs’ off- label promotion and medication guide allegations are entirely premised on alleged violations of the FDCA and FDA regulations, their actions are pre-empted in accord with Buckman. Plaintiffs’ actions, based upon the distribution of the medication guide, are equally deficient, and must be dismissed, because plaintiffs have not plead sufficient facts to support a plausible action that the plaintiffs’ failure to receive a medication guide was the result of Zydus’ and Taro’s failure to provide the pharmacy and/or distributor with the medication guide or the means to produce the guide in compliance with FDA regulations. Providing a medication guide to a user is a two-step process under the federal rules. First, the manufacturers are required to provide pharmacies or other drug dispensers/distributors with copies of a medication guide, or a means to produce them. See, 21 CFR §208.24(c). Second, the pharmacy or distributor of the amiodarone medication is required to provide the medication guide to the consumer when the medication is dispensed. See, 21 CFR §208.24(e). Zydus and Taro were not privy to the communications or transactions between the pharmacy/distributors and plaintiffs. Therefore, liability for failing to provide a medication guide should not, and cannot, be imputed to Zydus and Taro to the extent that a pharmacy/distributor failed to comply with the federal rules. The plaintiffs’ claims are also subject to dismissal for failing to state a claim under Fed. R. Civ. P. 12(b)(6) because plaintiffs failed to plead sufficient facts to satisfy the requirements enunciated in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), Ashcroft v. Iqbal, 556 U.S. 662 (2009) as well as the pleading requirements of Fed. R. Civ. P. 8(a) and 9(b). Plaintiffs’ FAC Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 9 of 30 5 1110608v.2 is based on conclusory allegations that Zydus and Taro negligently and fraudulently promoted amiodarone for off-label use, without identifying the specific conduct Zydus and Taro undertook, or the means by which Zydus and Taro communicated this information to the public. While plaintiffs’ allegations of off-label promotion has generally alleged fraud, plaintiff’s FAC does not contain any factual details alleging who, what, where, when and why. Lastly, there are 16 plaintiffs in 12separate states which have alleged a time-barred action. Based on the state statutes of limitations, various plaintiffs’ actions are time-barred. For all of these reasons, plaintiffs’ causes of action against Zydus and Taro should be dismissed in their entirety for lack of personal jurisdiction pursuant to the Federal Rules of Civil Procedure (“Fed. R. Civ. P.”) 12(b)(2), for failure to state a claim pursuant to Fed. R. Civ. P. 12(b)(6), for failure to sufficiently allege facts to satisfy the federal pleading requirements of Fed. R. Civ. P. 8(a)(2) and 9(b), and dismiss plaintiffs’ alleged time-barred causes of action which are precluded by the applicable state statute of limitations. STATEMENT OF FACTS This lawsuit was originally filed by three dozen plaintiffs and/or decedents on March 24, 201, against the Wyeth Pharmaceuticals, Inc. (“Wyeth”), the brand-name manufacturer of Cordarone®; eight different generic manufacturers of amiodarone - Sandoz, Inc. (“Sandoz”), Eon Labs, Inc. (“Eon”), Teva Pharmaceuticals USA, Inc. (“Teva”), Par Pharmaceutical Companies, Inc. (“Par”), Upsher-Smith Laboratories, Inc. (“Upsher”), Barr Pharmaceuticals, Inc. (“Barr”), as well as Zydus and Taro; and wholesale distributor McKesson Corporation (“McKesson”) (collectively referred to herein as “Defendants”) in California Superior Court for the County of Alameda. Plaintiffs filed their First Amended Complaint (“FAC”) on May 1, 2017, to name dozens of additional plaintiffs and/or decedents (hereinafter referred to collectively as “plaintiffs”) and to add defendant Mayne Pharma, Inc. (“Mayne”), a generic manufacturer of amiodarone. Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 10 of 30 6 1110608v.2 Currently, there are a total of sixty-two plaintiffs from seventeen different states that have alleged several causes of action against eleven different defendants, nine of which are generic manufacturers of amiodarone, a generic equivalent of the brand drug Cordarone®. Cordarone®/amiodarone is a prescription drug indicated for treating frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in certain patients. The defendants removed this case to the Northern District of California on May 5, 2017. (See, Doc. # 1). The FAC alleges that the plaintiffs (or their decedents or spouses) were injured as a result of ingesting the prescription medication amiodarone. (FAC ¶¶ 1-39). Plaintiffs have alleged broad, vague and generalized allegations concerning which generic defendant manufactured the amiodarone medication that allegedly caused harm to plaintiffs. Id. The action asserts identical allegations against the defendants and does not differentiate between the actions of any of the defendants. Because each plaintiff ingested amiodarone manufactured by different defendants (and thirty-one plaintiffs fail to allege any specific manufacturer’s amiodarone), it is likely that out of the sixty-two different plaintiffs, few if any will have claims against all defendants named in this case. In fact, only one plaintiff of the sixty two (Sandra Rhodes) has expressly alleged that she ingested amiodarone manufactured by “Zydus, Taro, Eon and potentially other Generic Defendants”. (FAC ¶ 5(c)). This allegation is still fatally vague since it does not identify when plaintiff ingested the amiodarone that was manufactured by Zydus and Taro, or how her injury was causally related to the amiodarone manufactured by Zydus and Taro. All other allegations by the plaintiffs either allege that another generic defendant manufactured the amiodarone he/she Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 11 of 30 7 1110608v.2 ingested or it is alleged that the amiodarone was “manufactured by one or more of the Generic Defendants”. (FAC ¶¶ 1-39). Amiodarone is the generic form of Cordarone®, a brand name drug manufactured by Wyeth Pharmaceuticals, Inc. (“Wyeth”). (FAC ¶ 66). Cordarone®/Amiodarone are approved by the FDA for the treatment of life-threatening recurrent ventricular arrhythmias when they have not responded to other available anti-arrhythmia medications or when other alternative agents could not be tolerated. (FAC ¶¶ 67-71). The FDA first approved Cordarone® for use in the United States when it approved Wyeth's New Drug Application (“NDA”) on December 24, 1985. (FAC ¶ 66, fn 7). In December 2004, pursuant to federal regulation (21 CFR §208.1), the FDA mandated that Cordarone® be accompanied by a medication guide for consumers. For drugs required to have a medication guide, FDA regulations obligate drug manufacturers to provide pharmacies and other drug dispensers either with copies of the medication guide or with the means to produce them. See, 21 CFR §208.24(c). Pharmacies are then required to provide the medication guide to the consumer when the medication is dispensed. See, 21 CFR §208.24(e). It is alleged that the plaintiffs were prescribed a course of 200 mg amiodarone tablets for the treatment of non-life threatening atrial fibrillation, which was an alleged off-label use. (FAC ¶¶ 1-39). It is further alleged that the plaintiffs had prescriptions filled at various pharmacies and those pharmacies never provided the plaintiffs with a medication guide for amiodarone because defendants never provided medication guides to the plaintiffs’ pharmacies. Id. Various injuries caused by the ingestion of amiodarone range from February 2007 to October 2016. Id. Plaintiffs’ causes of action against the defendants fall into three main categories: 1) failure to warn, 2) fraudulent off-label promotion and/or marketing, and 3) failure to provide a medication guide pursuant to federal regulation. Plaintiffs also alleged specific state law claims for unfair Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 12 of 30 8 1110608v.2 competition and unfair and deceptive business practice pursuant to California Business & Professions Code § 17200 and California Civil Code § 1750, respectively. These causes of action rely upon the allegations that the defendants, not specifying which defendant, failed to warn the FDA and healthcare providers of the risks of using amiodarone; that the defendants promoted and marketed amiodarone “off-label”; that the defendants failed to provide medication guides to the pharmacies where plaintiffs filled their amiodarone prescriptions; and that the plaintiffs relied upon the defendants representations about the “off-label” use of amiodarone, which subsequently caused their injuries. Throughout the entire 210 paragraph complaint, plaintiffs have failed to identify any specifics or particulars for each allegation as required by federal law, never identifying details about Zydus’ and/or Taro’s alleged off-label promotion or by what means Zydus and/or Taro communicated their respective “off-label” marketing campaign to the public. The FAC is composed of boilerplate contentions without any express facts regarding Zydus and/or Taro’s actions or activities to support the general allegations of the complaint or the basis for the causes of action asserted against Zydus and Taro. ARGUMENTS I. Defendants’ Zydus and Taro Are Not Subject To Jurisdiction in the State of California General Jurisdiction This Court has no jurisdiction over Zydus and Taro and the complaint must be dismissed. Zydus and Taro are incorporated in New Jersey and New York, respectively, and do not have a principal place of business in California, which plaintiffs conceded in the FAC. (FAC ¶¶ 45, 46). Neither Zydus nor Taro have any offices or property owned by the company in the state of California, any telephone number or address in California, any employees operating in California, and no property owned by the company. Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 13 of 30 9 1110608v.2 California’s long arm statute permits personal jurisdiction over a non-resident defendant to the extent it is permitted by the Constitution. Cal. Code Civ. Proc. § 410.10. Therefore, California’s long-arm statute is coextensive with federal due process requirements, so the jurisdictional analyses under state law and federal due process are the same. Pebble Beach Co. v. Caddy, 453 F.3d 1151, 1155 (9th Cir. 2006). The constitutional due process inquiry for exercising personal jurisdiction “requires that the defendant ‘have certain minimum contacts’ with the forum state ‘such that the maintenance of the suit does not offend ‘traditional notions of fair play and substantial justice.’” Ranza v. Nike, Inc., 793 F.3d 1059, 1068 (9th Cir. 2015) (quoting Int’l Shoe Co. v. Washington, 326 U.S. 310, 316 (1945) (quoting Milliken v. Meyer, 311 U.S. 457, 463 (1940)). In Daimler AG v. Bauman, 134 S. Ct. 746 (2014), the Court held that general personal jurisdiction exists only where the defendant’s “affiliations with the [forum] State are so ‘continuous and systematic’ as to render [it] essentially at home” there. Id. at 754; quoting, Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 919 (2011). As noted by the Supreme Court, in Daimler, a corporation will be considered “at home” for purposes of general jurisdiction only in its state of incorporation and where its principal place of business is located. Daimler, 134 S. Ct. at 761. By this standard, Zydus and Taro are “at home” in New Jersey and New York, respectively. The fact that Zydus and Taro have engaged in activity of some sort within the state of California, is not enough to assert general jurisdiction. Goodyear, 564 U.S. at 927, quoting Int’l Shoe, 326 U.S. at 318 (holding that a “corporation’s ‘continuous activity of some sorts within a state’… ‘is not enough to support the demand that the corporation be amenable to suits unrelated to that activity.’”). While plaintiffs alleged that Zydus and Taro so business in California, that alone is insufficient under Daimler to deem Zydus and Taro “at home” in this Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 14 of 30 10 1110608v.2 jurisdiction. Daimler, 134 S. Ct. at 760. As a result, plaintiffs have not, and cannot, establish that Zydus and Taro are subject to general jurisdiction in California and personal jurisdiction does not exist on this basis. b. Specific Jurisdiction To establish specific jurisdiction, a plaintiff must demonstrate all of the following: (1) the defendant purposefully directed its activities at residents of the forum; (2) the litigation results from alleged injuries that arise out of or relate to those activities directed at forum residents; and (3) the exercise of jurisdiction comports with fair play and substantial justice. Williams v. Yamaha Motor Co., 851 F.3d 1015, 1023 (9th Cir. 2017). While Zydus and Taro sell their amiodarone product to pharmacies and distributors in California (and every other state in the U.S.), the Amended Complaint fails to establish the second and third prerequisites for specific jurisdiction - that is, that no forum resident has specifically alleged that their injuries arose out of or related to the activities of Zydus or Taro, and having California adjudicate a case with non-resident plaintiffs and defendants does not comport with fair play and substantial justice. The Amended Complaint fails to assert facts sufficient to connect any relevant activity by Zydus or Taro to the State of California. A court cannot exercise specific jurisdiction over an out- of-state defendant, even one with “minimum contacts” with the forum state, where the “episode- in-suit” occurred outside the forum. See, Goodyear, 564 U.S. at 919-20. There are a total of fifty- six non-resident plaintiffs that cannot establish specific jurisdiction over Zydus and Taro. These plaintiffs’ causes of action do not arise out of or relate to Zydus’ or Taro’s contacts with California. The fifty-six plaintiffs are not California residents and fifty-four of these plaintiffs have not Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 15 of 30 11 1110608v.2 specifically alleged that Zydus and/or Taro manufactured the amiodarone they ingested.1 All of the ingestions, the prescriptions and the injuries occurred outside of California. The six California residents have alleged no specific allegations against Zydus and/or Taro, nor did they identify that the amiodarone drug purchased and ingested by plaintiff in California was manufactured by Zydus or Taro. Therefore, not one plaintiff in the entire complaint alleged that they received their amiodarone prescription manufactured by Zydus and/or Taro in California, ingested this drug in California, and was injured by the drug in California. There is no evidence that either defendant had the minimum contacts to sustain jurisdiction where such minimum contacts require a direct connection between the cause of action and the defendant’s contacts. Goodyear, 564 U.S. at 923-925. Williams v. Yamaha Motor Co., 851 F.3d 1015, 1023 (9th Cir. 2017), quoting Dole Food Co., Inc. v. Watts, 303 F.3d 1104, 1111 (9th Cir. 2002) (“We will exercise specific jurisdiction over a non-resident defendant only when three requirements are satisfied: (1) the defendant either ‘purposefully direct[s]’ its activities or ‘purposefully avails’ itself of the benefits afforded by the forum’s laws; (2) the claim ‘arises out of or relates to the defendant’s forum-related activities; and (3) the exercise of jurisdiction [ ] comport[s] with fair play and substantial justice, i.e., it [is] reasonable.’”). This Court cannot exercise specific jurisdiction over these defendants since to do so would be inconsistent and in conflict with the requirements of due process as enunciated by the United States Supreme Court and various federal courts, including this Circuit. Factors to determine whether jurisdiction would comport with well-established notes of fair play and substantial justice include, (1) the burden on the defendants, (2) the forum state’s interest in adjudicating the dispute, 1 Although extremely vague and ambiguous, only two plaintiffs, Sandra Rhodes and her husband Charles Rhodes, specifically alleged that “Zydus, Taro, Eon and potentially other Generic Defendants” manufactured and distributed the amiodarone Sandra Rhodes was prescribed. (See, FAC ¶ 5(c)). Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 16 of 30 12 1110608v.2 (3) plaintiffs’ interests in obtaining convenient and effective relief; (4) the court’s interest in obtaining the most efficient resolution of controversies, and (5) the shared interest of the several states in furthering fundamental substantive social policies. Burger King Corp. v. Rudzewicz, 471 U.S. 462, 477 (1985). The plaintiffs’ causes of action do not arise out of or relate to Zydus and/or Taro’s contacts with California since these plaintiffs do not allege that any product sent into this state was purchased or ingested in this state. Moreover, Zydus and Taro are not incorporated or maintain a principal place of business or any office in California, and do not have facilities with employees working in California. It would be burdensome for Zydus and Taro to defend this action in California and inefficient to maintain a venue so far from the location of 92% of the plaintiffs, treating physicians and witnesses. California has no interest in adjudicating disputes between non- California plaintiffs and non-California defendants. As stated above, there has been no alleged injury arising from Zydus or Taro’s amiodarone product connected with this jurisdiction. Accordingly, there is no specific jurisdiction over Zydus or Taro and this matter should be dismissed in its entirety as a result. II. Plaintiffs’ Action for Failure to Warn Should Be Dismissed In Its Entirety Because It Is Pre-empted By Federal Law Plaintiffs generally allege that all nine of the generic amiodarone defendants “failed to warn the public and Plaintiffs of material facts regarding the safety and efficacy of Cordarone®/Amiodarone” and its label is “defective due to inadequate post-marketing warning and instruction.” (FAC ¶¶ 122, 125). These allegations regarding a generic manufacturers warnings and labeling are pre-empted by federal law. PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011). Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 17 of 30 13 1110608v.2 The plaintiff in Mensing similarly had argued that the generic manufacturer was liable under state tort law for failure to provide adequate warnings. The Court evaluated the duties and regulations controlling the activities of generic manufacturers and concluded that plaintiff's action for failure to warn should be dismissed because such an action was impliedly pre-empted by federal law. As noted by the Court, generic manufacturers, such as Zydus and Taro, “have an ongoing federal duty of sameness” which requires that the labeling and warnings for generic products be identical to those of their brand-name counterparts. Id. at. 2574-75; 21 U.S.C. § 355(j)(2)(A). Since the FDA's Changes Being Effected (CBE) regulations were not available to generic manufacturers, such as Zydus and Taro, the instant an action under state law for failure to warn was pre-empted since it is impossible for Zydus or Taro as a generic manufacturer to unilaterally change the label to strengthen or add new warnings without violating FDA regulations. See, Mensing. 131 S. Ct. at 2575. Upon Zydus and Taro receiving FDA approval of its ANDA, the only duty incumbent upon Zydus and Taro - generic manufacturers - with respect to its warnings under federal law, would be a “duty of sameness”. Zydus and Taro were, and still are, prohibited from independently changing their labeling without prior FDA approval. Id. at 2577. The scope of Mensing’s preemption, equally applicable in this proceeding to Zydus and Taro, has been extended to design defect actions or those actions alleging a duty to withdraw from the market. See, Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466 (2013). The court in Bartlett held that the plaintiff's action was pre-empted by federal law for the same reasons delineated in Mensing. Bartlett, 133 S.Ct. at 2479 (holding that an action under state law for design defect that required a generic manufacturer to either alter the drug composition or the label, conflicted with federal law and prohibited the generic manufacturer from unilaterally altering the drug composition or label). Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 18 of 30 14 1110608v.2 This district has found similar failure-to-warn claims preempted under Mensing. See, Ko v. Mutual Pharm. Co., Inc., 2013 WL 5692375, No. C13-0890-RMW (N.D. Cal. Oct. 18, 2013) (The court agreed that Mensing and Bartlett mandated a finding that the plaintiff’s strict liability, negligence, and unfair competition claims were “all based on a failure-to-warn theory and consequently preempted by federal law.” Id. at *2.) The overwhelming majority of state and federal courts, including the district courts in California and Ninth Circuit2, have recognized the impact of Mensing that no state law tort claims attacking a generic drug’s warnings, representations, or disclosures can survive federal preemption. See, Moretti v. Wyeth, 579 F. App’x. 563 (9th Cir. 2014) (holding an action based on alleged dissemination of inaccurate, misleading, materially incomplete, false, and otherwise inadequate information concerning the potential effects of exposure to the generic drug, as well as a failure to warn doctors and patients of information within its knowledge and possession was subject to preemption). Here, Zydus and Taro are faced with the same challenge. Federal law governs Zydus and Taro’s amiodarone labeling, including the Medication Guide, and Zydus and Taro cannot unilaterally take action to change the labeling in a way that deviates from the brand innovator’s labels. As such, plaintiff’s failure-to-warn claims are untenable because they require action from Zydus and Taro in conflict with the federal regulatory scheme, and are thus preempted. Consistent with movants’ request for dismissal, numerous other district courts have granted motions to dismiss on failure-to-warn claims in cases involving the exact same product - generic 2 See also In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., No. 05-1699 CRB, 2006 WL 2374742, at *10 (N.D. Cal. Aug. 16, 2006) (“[P]laintiffs’ claims premised on Pfizer’s failure to warn consumers and physicians of cardiovascular risk are dismissed as preempted”); Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC, 2014 WL 819392, at *3 (C.D. Cal. Feb. 14, 2014) (failure to warn claims preempted); Frere v. Medtronic, Inc., No. 15-2338, 2016 WL 1533524, at *8 (C.D. Cal. Apr. 6, 2016) (“Plaintiff’s failure to warn cause of action is expressly preempted.”); Houston v. Medtronic, 957 F.Supp.2d 1166, 1177 (C.D. Cal. 2013) (“Plaintiff aims to foist upon Defendants labeling or warning requirements ‘in addition to’ what federal law requires. Therefore, the claim is expressly preempted.”). Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 19 of 30 15 1110608v.2 amiodarone - when presented with very similar allegations.3 In Rusk, the court addressed nearly identical claims regarding amiodarone, and the Court found all of plaintiff’s failure-to-warn claims preempted as a matter of law. Rusk v. Wyeth-Ayerherst Laboratories, Inc., 2015 WL 3651434 (W.D. Tex. June 11, 2015). Likewise, in Stephens, the Northern District of Alabama held that under Mensing, failure-to-warn claims are “wholly preempted by federal law,” and plaintiffs could not “sue a generic manufacturer on a failure to warn claim or a state law design defect claim that turns on the adequacy of a drug’s warnings.” Stephens, 70 F. Supp. 3d at 1250. Most recently, in Elliott, the court cited Mensing when it dismissed the same failure-to-warn claims asserted relating to generic amiodarone. Elliott, 2016 WL 4398407, at *5-6.4 Further, any allegation that Zydus or Taro failed to test or inspect the product (FAC ¶¶ 126, 177) would also fail as being within the scope of an action for failure to warn. Morris, 713 F.3d at 778 (holding that any testing or inspecting of the product would consist of a warning, which is preempted by federal law). III. Plaintiff’s Off-Label Promotion Claims Are Preempted and Should be Dismissed This court should not permit plaintiffs to circumvent pre-emption by alleging that Zydus or Taro unlawfully promoted its generic amiodarone product for off-label uses. Plaintiffs’ action based on alleged off-label promotion is equally pre-empted under two different pre-emption principles. Plaintiffs’ actions, based upon off-label promotion, is a guise for failure to warn, subject to federal pre-emption under Mensing. The FAC is comprised of numerous allegations asserting that Zydus and Taro, along with all the other defendants, actively and fraudulent engaged in off-label 3 See Rusk v. Wyeth-Ayerherst Laboratories, Inc., 2015 WL 3651434 (W.D. Tex. June 11, 2015)(granted in part); Stephens v. Teva Pharm. Inc., et al., 70 F. Supp. 3d 1246, 1254 (N.D. Ala. 2014) (dismissing all claims with prejudice); Perdue v. Wyeth Pharmaceuticals, Inc., 209 F.Supp.3d 847 (E.D.N.C., July 20, 2016) (dismissing all claims with prejudice); Elliott v. Sandoz Inc., 2016 WL 4398407, at *9 (N.D. Ala. Aug. 18, 2016) (granted in part). 4 See also, Lashley v. Pfizer, Inc. 750 F.3d 470, 474 (5th Cir. 2014) (holding that the duty to sameness extends to Dear Doctor letters and other forms of warnings from a generic manufacturer); Morris v. PLIVA, Inc., 713 F.3d 774, 776-77 (5th Cir. 2013) (“Whether a warning is placed on the label, on the bottle or in letters to distributors, any state law duty requiring generic manufacturers to act unilaterally in this area is preempted by federal law.”). Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 20 of 30 16 1110608v.2 promotional efforts to market amiodarone as a first-choice cardiac drug for non-life threatening heart ailments, including atrial fibrillation - an “off-label” use. (FAC ¶¶ 74, 82, 89, 180, 181, 182). Specifically, plaintiffs have alleged that Wyeth engaged in an extensive off-label promotional campaign that the “generic defendants” subsequently benefitted from, and continues to reap benefits of. (FAC ¶¶ 71, 72, 88-107). Irrespective of whether Zydus or Taro may have conducted any off-label promotion for its generic amiodarone product, which is denied, Zydus and Taro are still prohibited by the FDCA and FDA regulations from adding or strengthening any warnings for the product to address risks associated with off-label uses. Zydus and Taro were legally required to conform their labeling and warnings to Cordarone®’s label. Because plaintiffs’ allegations of fraudulent and deceptive off-label promotion ultimately challenge the adequacy of the warnings that accompanied Zydus’ and Taro’s amiodarone product, the actions based on purported off-label promotion are pre-empted under Mensing. Plaintiffs’ off-label promotion allegations are impliedly pre-empted by federal law. See, Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). In Buckman, the Supreme Court held that alleged violations of FDA regulations cannot form the basis for a cause of action unless plaintiffs' action is grounded on traditional state law principles. 531 U.S. at 353 (2001). The court held that plaintiffs' action based on alleged fraud-on-the-FDA was pre-empted because: (1) such an action was premised on alleged violations of FDA regulations rather than any traditional state law principles; and (2) only the federal government has the authority to bring an action to enforce the FDCA and FDA regulations. 531 U.S. at 348-49; see also, 21 U.S.C. §337(a). In addition, numerous California district courts have held that off-label promotion actions are impliedly preempted under Buckman. See Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1177 (C.D. Cal. 2013) (holding “any negligence claim based solely on illegal off-label promotion Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 21 of 30 17 1110608v.2 is impliedly preempted under Buckman and § 337(a)”); Dunbar v. Medtronic, Inc., No. CV 14- 01529-RGK, 2014 WL 3056026, at *5 (C.D. Cal. June 25, 2014) (“[T]here is no claim for illegal off-label promotion rooted in traditional state tort law. Therefore, any common law claim arising from such an action exists only by virtue of the FDCA. Permitting this claim to proceed would essentially allow a private litigant to attempt enforcement of the FDCA. Buckman bars such an action under § 337(a).”); Anderson v. Medtronic, Inc., 2015 WL 2115342, at *6 (S.D. Cal. May 6, 2015) (“There is no state law claim for negligence based on off-label promotion. In fact, there would be no such thing as off-label promotion without the federal statutory scheme. In other words, Plaintiffs allege Defendants are negligent because they violate the federal statutory scheme by promoting off-label use. Such a claim is impliedly preempted under Buckman.”). Plaintiffs base their off-label promotion actions on the “Defendants” alleged violation of the FDA regulations that it is “unlawful for a manufacturer to promote any drug for a use not described in the approved labeling of the drug,” 21 U.S.C. §§ 331(d), 352(f), and 355. (See, FAC ¶ 68, fn 10). California law does not contain similar restrictions related to off-label promotion. See, e.g., Houston, 957 F. Supp. 2d at 1177 (holding “any negligence claim based solely on illegal off- label promotion is impliedly preempted under Buckman and § 337(a)”). Therefore, because plaintiffs’ off-label promotion actions against Zydus and Taro are based solely on alleged violations of federal law, these causes of action are impliedly preempted under Buckman. IV. Plaintiffs’ Causes of Action Based on the failure to distribute Medication Guides Claim Are Preempted By Federal law and Should be Dismissed For the same reasons argued above, plaintiffs’ causes of action based on a purported failure to provide medication guides are also impliedly pre-empted by federal law. Plaintiffs alleged that Zydus and Taro violated FDA regulations because they allegedly failed to distribute medication guides to the plaintiffs, distributors and pharmacies. (FAC ¶¶ 78, 79, 82, 85, 108, 113, 145, 151, Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 22 of 30 18 1110608v.2 158, 165, 171, 178, 195, 202(f)). Plaintiffs do not allege that the absence of a medication guide violated any state statute or common law duty. Plaintiffs’ actions based on this allegation are solely rooted in a purported violation of FDA regulations that defendants Zydus and Taro contend do not bestow upon the plaintiffs a private right to enforce. The duty of manufacturers to provide a Medication Guide or to make one available is created by federal law, and no private right of action exists under state law to permit plaintiffs to pursue violations of this exclusive federal duty. See 21 C.F.R. §208.24(b); see also 21 U.S.C. §337(a). “The duty of the Defendant to provide Medication Guides to pharmacies (i.e., “distributors, packers or authorized dispensers”) arises solely under federal law.” Elliott, supra, 2016 WL 4398407, at *6 (emphasis added). Thus, plaintiffs have no right to enforce the regulation requiring distribution of a Medication Guide, and actions relating to Zydus and Taro’s alleged failure to provide Medication Guides to distributors should be dismissed as impliedly preempted. See Buckman, 531 U.S. at 349. In Perdue, supra, a virtually identical case, the Eastern District Court of North Carolina dismissed both off-label promotion and failure to provide Medication Guide action involving generic amiodarone, finding both to be impliedly preempted pursuant to Buckman and 21 U.S.C. §337(a). Perdue, supra, 2016 WL 3951091 at *3-6. Perdue first recognized that traditional products liability claims - similar to those alleged in the instant FAC - against generic manufacturers of amiodarone are preempted by Mensing and Bartlett, and also held that off-label promotion and Medication Guide actions are premised upon federal duties that only the federal government has the right to enforce. Id. at *3. Applying Buckman, the Perdue court recognized this lack of a private right of action was fatal to both off-label promotion actions and those based on failure to provide a Medication Guide, both of which necessarily depend on purported violations Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 23 of 30 19 1110608v.2 of exclusively federal duties. Id. at *5-6. As such, the court in Perdue dismissed both causes of action. Id. The Western District of Texas has properly held that, while manufacturers are responsible for ensuring medication guides are available for distribution, it is the “end distributor” or the pharmacy which has the ultimate responsibility for providing the medication guides directly to the patient. Rusk v. Wyeth-Ayerherst Laboratories, Inc., 2015 WL 3651434 * 1 (W.D. Tex. June 11, 2015). Here, the plaintiffs have all alleged that they received their amiodarone medication directly from the pharmacy. Zydus and/or Taro were not privy to any communications or transactions between the pharmacies and plaintiffs. Therefore, plaintiffs cannot argue that Zydus and/or Taro were responsible for providing the plaintiffs with the FDA required medication guide. Zydus and Taro’s only responsibility under the federal rules is to ensure the end distributor had the means of providing the medication guide to the consumer. See, 21 CFR §208.24(c); see also, Connolly v. Sandoz Pharms. Corp., No. 2:14-cv-152-WCO (N.D. Ga. December 23, 2014) (dismissing plaintiff’s off-label promotion and failure to provide medication guide claims since the off-label promotion claims challenged the adequacy of the warnings, which was held to be pre-empted under Mensing, and the medication guide claims was based on a violation of the FDA regulations which is preempted by court in Buckman.); Dreher v. Wyeth Pharmaceuticals, Inc., 2015 WL 3948961 at 8 (N.D. Ala. Jun. 29, 2015) (dismissing the action based on failure to provide a medication guide in a generic amiodarone case because it arose solely by operation of federal law, pre-empted under Buckman). V. Plaintiffs’ First Amended Complaint Must Be Dismissed In Light of the Insufficiency in the Pleading of the Actions Even if plaintiffs’ actions are not subject to preemption, the FAC would still be subject to dismissal under Fed. R. Civ. P. 12(b)(6), due to plaintiff’s insufficient pleading under Fed. R. Civ. Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 24 of 30 20 1110608v.2 P. 8(a)(2) and 9(b). To survive a motion to dismiss, the pleading must contain sufficient factual matter, accepted as true, to state a claim of relief that is plausible on its face. Fed. R. Civ. P. 12(b)(6). Although the court should accept as true all well-pleaded allegations and should view the complaint in a light most favorable to the plaintiff, the “factual allegations must be enough to raise a right to relief above the speculative level” such that plaintiffs claim to relief is “plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 550 (2008). The complaint must demonstrate “more than a sheer possibility that a defendant has acted unlawfully.” Id. The Causes of Action Alleged in Plaintiffs’ First Amended Complaint Are Not Pled with Sufficient Facts to Satisfy Rule 8(a) Fed. R. Civ. P. 8(a)(2) requires that the complaint provide “a short and plain statement of the claim showing that the pleader is entitled to relief.” Pleadings that contain nothing more than “a formulaic recitation of the elements of a cause of action” do not meet the standards of Rule 8(a), nor do pleadings suffice that are based merely upon “labels and conclusions” or “naked assertion[s]” without supporting factual allegations. Twombly, 550 U.S. at 555, 557. In Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009), the United States Supreme Court articulated a two-step process for determining whether a complaint has set forth sufficient facts to survive a motion to dismiss. First, the court must identify those allegations that, because they are no more than conclusions, are not entitled to the assumption of truth. Id. at 680-681. “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice,” Id. at 678, citing Twombly, 550 U.S. at 554-55. Second, the court should assume the truth of well- pleaded factual allegations, if the complaint contains any, and determine whether they plausibly give rise to an entitlement to relief. Ashcroft, 556 U.S. at 681. “Where the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 25 of 30 21 1110608v.2 alleged - but has not ‘show[n]’ - ‘that the pleader is entitled to relief,”’ and, it, therefore, should be dismissed. Id. at 679. Plaintiffs’ allegations are insufficient to satisfy Rule 8 because they fail to allege specific instances of misconduct. Plaintiffs offer no facts to support the allegations, and therefore, the allegations are quintessential examples of the “naked assertions[s] devoid of further factual enhancement” that the U.S. Supreme Court declared to be insufficient to survive a motion to dismiss. Id. at 678. Plaintiffs allege general facts through the FAC that all defendants, not specifying the conduct of each one, engaged in a “calculated and coordinated campaign of silence” regarding the safety and efficacy of amiodarone, as well as, a “massive and illegal marketing and promotional scheme” to aggressively promote amiodarone for uses never authorized by the FDA. (FAC ¶¶ 52, 126, 165, 182). However, not once in plaintiffs’ 210 paragraph complaint did they identify the substance of Zydus or Taro’s “massive” marketing and promotional campaign and/or scheme, or by what means this campaign / scheme was conveyed to the users, healthcare providers, pharmacists, plaintiffs’ prescribing physicians, or plaintiffs’ themselves. Plaintiffs never even identified where they or their prescribing physicians encountered this alleged off-label marketing campaign / scheme. Given that plaintiffs allege that the generic defendants engaged in an “aggressive” and “massive” marketing and promotional scheme, it should be expected that plaintiffs can provide at least one example of such wrongful and deceptive marketing by Zydus and/or Taro. Yet, plaintiffs have failed to identify even one specific instance of Zydus’ or Taro’s alleged off-label promotion of amiodarone. In contrast, plaintiffs notably provided half a dozen specific examples of Wyeth’s alleged wrongful and fraudulent marketing. (FAC. ¶¶ 88, 89, 92, 95, 101, 103, 104). Plaintiffs accuse Wyeth of starting a fraudulent and off-label marketing campaign in the 1990’s and attempts Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 26 of 30 22 1110608v.2 to vicariously affix this allegation to the generic defendants, without any specific allegation or evidence that Zydus and/or Taro adopted Wyeth’s promotional or marketing efforts. The Western District of Texas recently dismissed this same cause of action against a generic manufacturer of amiodarone because the plaintiff in that action had not established what promotional activities influenced plaintiff’s physicians, and/or what risks were concealed to plaintiff’s physicians. Rusk, 2015 WL 3651434 at *7. Moreover, to survive an action for failure to provide a medication guide, plaintiffs are required to allege whether the specific pharmacy where plaintiffs filled their prescription failed to provide a medication guide to him; and most importantly whether the pharmacy failed to do so because Zydus and/or Taro had not supplied the guide to the pharmacy. See, Stevens v. Teva Pharmaceuticals, 2014 WL 7723296 (N.D. Ala. Oct. 1, 2014)(holding that without a “well- founded allegation” that the pharmacy failed to provide a medication guide to plaintiff because the manufacturer did not supply the guide to the pharmacy, the claim cannot survive); see also, 21 C.F.R. §208.24. Plaintiffs’ allegations do not specify which generic defendant manufactured the amiodarone ingested by each particular plaintiff. Without particularized allegations, plaintiffs’ FAC fails to satisfy the pleading requirements under the federal rules. Plaintiffs’ Action Based On Allegations of Fraud Is Not Pled With Sufficient Facts To Satisfy Rule 9(b) Where the complaint includes allegations couched in terms of fraud, Rule 9(b) imposes a heightened pleading standard that requires that the action be pled with particularity. Fed. R. Civ. P. 9(b) (“In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”). Rule 9(b) requires that the circumstances surrounding the alleged fraud be pled with particularity including the time, place and content of the false representations, the identity of the person making the representations, and what that person obtained. See, Kearns Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 27 of 30 23 1110608v.2 v. Ford Motor Co., 567 F.3d 1120, 1124 (9th Cir. 2009) (allegations must “be specific enough to give defendants notice of the particular misconduct … so that they can defend against the charge and not just deny that they have done anything wrong.”) California law requires that in actions for intentional fraud, a claimant is required to prove each and every element: “(a) misrepresentation (false representation, concealment, or nondisclosure); (b) knowledge of falsity (or ‘scienter’); (c) intent to defraud, i.e., to induce reliance; (d) justifiable reliance; and (e) resulting damage.” Lazar v. Super. Ct., 12 Cal. 4th 631, 638 (1996). In order to state a claim of fraud with sufficient particularity pursuant to Rule 9(b), fraud requires particularity, that is, “pleading facts which show how, when, where, to whom, and by what means the representations were tendered.” Stansfield v. Starkey, 220 Cal.App.3d 59, 73 (1990); Kearns, 567 at 1124. Furthermore, every element of a fraud cause of action must be alleged both factually and specifically. Cooper v. Equity General Ins., 219 Cal.App.3d 1252, 1262 (1990). When read together, Rules 9(b) and 12(b)(6) require a plaintiff to allege each necessary element of a fraud or misrepresentation claim in order to survive a motion to dismiss. The FAC at issue in this action has failed to identify or specify the fraudulent statements, who specifically made these fraudulent statements, when the statements were made, where they were made or why such statements were considered fraudulent. Plaintiffs’ general allegations are so broad and vague that these allegations could be applied against any pharmaceutical drug manufacturer in the United States. The federal pleading requirements, however, are to be strictly construed to prevent abuses by plaintiffs and prevent baseless lawsuits from flooding the judicial system. Plaintiffs have lumped all allegations against the “generic defendants” together and have not identified the time, place or content of the purported off-label promotion or fraudulent conduct Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 28 of 30 24 1110608v.2 by Zydus or Taro, let alone which specific promotion or advertisement each defendant would be responsible. See, Swartz v. KPMG LLP, 476 F.3d 756, 764 (9th Cir. 2007) (“In the context of a fraud suit involving multiple defendants, a plaintiff must, at a minimum, identify the role of each defendant in the alleged fraudulent scheme.”). Additionally, plaintiffs have not identified any particular literature used by Zydus or Taro to promote amiodarone for off-label use. These allegations satisfy neither the “precise statements” nor the “time, place and person” requirements of Rule 9(b). Without factual support, plaintiffs’ general allegations that the generic defendants engaged in fraudulent promotion and marketing of amiodarone cannot survive a motion to dismiss. VI. Plaintiffs’ Claims Are Barred By The Applicable State’s Statute Of Limitations Even if this court determines that it has personal jurisdiction over these cases, that plaintiffs’ claims are not preempted under federal law, and that plaintiffs have sufficiently pled its causes of action, there are at least sixteen plaintiffs whose claims are barred by their state’s statute of limitations. Dismissal under Rule 12(b)(6) is appropriate when a plaintiff’s complaint makes clear his claims are barred by the applicable statute of limitations. Lukovsky v. City & Cnty of S.F., 535 F.3d 1044, 1052 (9th Cir. 2008) (upholding dismissal pursuant to Rule 12(b)(6) on statute of limitations grounds). All of the plaintiffs’ claims on the chart below are barred by their state’s applicable statute of limitations. As a result, their causes of action must be dismissed in its entirety. State Plaintiffs (Approx. date of injury) State’s Applicable Statute of Limitations Alabama Cobb (1/2014), Duncan (11/2014), Rhodes (12/2011) 2 years - Ala. Stat §6-2-38 (FAC ¶¶ 4(g), 34(g), 5(g)) Arizona Caldwell (4/2015) 2 years - A.R.S. §§ 12-551, 12-542 (FAC ¶ 38(g)) California Medford (2/2015) 2 years - Cal. Code Civ. Proc. §335.1, 340.8(a) (FAC ¶ 16(g)) Georgia Ackerman (10/2014), Bussell (2/2007), Bennett (1/2015) 2 years - O.C.G.A. §9-3-33 (FAC ¶¶ 25(g), 29(g), 3(g)) Kentucky Coontz (8/2015) 1 year - Ky. Rev. Stat. §413.140(1)(a) (FAC ¶ 21(g)) Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 29 of 30 25 1110608v.2 Michigan Bivens (3/2014) 3 years - MCLA §600.5805(13) (FAC ¶ 7(g)) North California Jenkins (9/2012) 3 years - N.C.G.S.A. §1-52(16), 1-52(1)-(5) (FAC ¶ 30(g)) Ohio Murphy (5/2012) 2 years - Ohio Rev. Code Ann. §2305.10(A) (FAC ¶ 17(g)) Pennsylvania Sopp (4/2015) 2 years - 42Pa. Consol. Stat. §5524(2) (FAC ¶ 20(g)) South California Ayers (11/2008) 3 years - S.C. Code Ann. §15-3-530, 15-3-535 (FAC ¶ 28(g)) Tennessee Burns (2/2016) 1 year - Tenn. Code Ann. §28-3-104 (FAC ¶ 24(g)) Texas Hart (5/2010) 2 years - Tex. Civ. Prac. & Rem. Code Ann. §16.003 (FAC ¶ 9(g)). CONCLUSION For the foregoing reasons, this Court should dismiss Plaintiffs’ First Amended Complaint against Zydus and Taro, in its entirety, for lack of personal jurisdiction pursuant to the Federal Rules of Civil Procedure (“Fed. R. Civ. P.”) 12(b)(2), for failure to state a claim pursuant to Fed. R. Civ. P. 12(b)(6), for failure to allege necessary facts in satisfaction of the federal pleading requirements under Fed. R. Civ. P. 8(a)(2) and 9(b), and for plaintiffs’ claims which are barred by their applicable state’s statute of limitations. DATED: June 15, 2017 Respectfully Submitted, /s/ Roberto M. Alonso Olmo Roberto M. Alonso Olmo (SBN 300986) Morrison Mahoney LLP 120 Broadway, Suite 1010 New York, NY 10271 ralonso@morrisonmahoney.com Counsel for Defendants Zydus Pharmaceuticals USA, Inc. and Taro Pharmaceuticals USA, Inc. Case 3:17-cv-02609-SI Document 70 Filed 06/15/17 Page 30 of 30 1 1111130v1 Roberto M. Alonso Olmo (SBN 300986) Morrison Mahoney LLP 120 Broadway, Suite 1010 New York, NY 10271 ralonso@morrisonmahoney.com Counsel for Defendants Zydus Pharmaceuticals USA, Inc. and Taro Pharmaceuticals USA, Inc. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA ------------------------------------------------------------------------- EDWIN STREED, et al., Plaintiffs, -against- WYETH PHARMACEUTICALS, INC., SANDOZ, INC., EON LABS, INC., TEVA PHARMACEUTICALS USA, INC., PAR PHARMACEUTICALS COMPANIES, INC.; ZYDUS PHARMACEUTICALS USA, INC.; TARO PHARMACEUTICALS USA, INC.; UPSHER-SMITH PHARMACEUTICALS, INC.; BARR PHARMACEUTICALS INC.; McKESSON CORPORATION; and DOES 1-50, Inclusive, Defendants. ------------------------------------------------------------------------- Case No. 3:17-CV-02609 [PROPOSED] ORDER GRANTING DEFENDANTS ZYDUS PHARMACEUTICALS USA, INC. AND TARO PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT Date: July 19, 2017 Time: 2:00 p.m. Judge: TBD Courtroom: TBD Before the Court is Defendants Zydus Pharmaceuticals USA, Inc. (“Zydus”) and Taro Pharmaceuticals USA, Inc.’s (“Taro”) Motion to Dismiss Plaintiffs’ First Amended Complaint and each purported claim set forth therein against Zydus and Taro with prejudice (the “Motion”). Having considered the Motion, the Memorandum of Points and Authorities in support thereof, and any opposition and reply thereto, the Court finds that pursuant to Federal Rules of Civil Procedure 12(b)(2) and 12(b)(6), Zydus and Taro’s Motion to Dismiss should be GRANTED in its entirety. Case 3:17-cv-02609-SI Document 70-1 Filed 06/15/17 Page 1 of 2 2 1111130v1 IT IS HEREBY ORDERED that all claims in the First Amended Complaint against Zydus and Taro are DISMISSED WITH PREJUDICE. IT IS SO ORDERED. Dated: ____________, 2017 HON. __________________ UNITED STATES DISTRICT JUDGE Case 3:17-cv-02609-SI Document 70-1 Filed 06/15/17 Page 2 of 2