Holland v. Bristol-Myers Squibb Company et alMOTION to Dismiss for Lack of Jurisdiction or, in the Alternative, to TransferN.D. Cal.May 26, 2017 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 DONALD F. ZIMMER, JR. (Bar No. 112279) fzimmer@kslaw.com WILLIAM E. STEIMLE (Bar No. 203426) wsteimle@kslaw.com KING & SPALDING LLP 101 Second Street, Suite 2300 San Francisco, CA 94105 Telephone: +1 415 318 1200 Facsimile: +1 415 318 1300 Attorneys for Defendants BRISTOL-MYERS SQUIBB COMPANY; ASTRAZENECA PHARMACEUTICALS LP; AND MCKESSON CORPORATION IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA ANITA ROCHELLE HOLLAND, Plaintiff, v. BRISTOL-MYERS SQUIBB COMPANY; ASTRAZENECA PHARMACEUTICALS LP; and McKESSON CORPORATION Defendants. Case No. 3:17-cv-02430-JST NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION (FRCP 12(B)(2)) OR, IN THE ALTERNATIVE, TO TRANSFER (28 U.S.C. § 1404(A)) Date: July 6, 2017 Time: 2:00 p.m. Judge: Hon. Jon S. Tigar Courtroom: 9 Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 1 of 24 i NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 TABLE OF CONTENTS MEMORANDUM OF POINTS AND AUTHORITIES .................................................................4 I. INTRODUCTION .....................................................................................................................4 II. BACKGROUND .......................................................................................................................5 III. ARGUMENT .............................................................................................................................6 A. Personal jurisdiction exists only in a forum where the defendant is “at home” or where a defendant’s contacts with the forum are the cause of the plaintiff’s injuries..................................................................................................................................6 1. The Supreme Court’s decisions in Goodyear and Daimler foreclose general jurisdiction over BMS and AstraZeneca because they are not at home in California .......................................................................................................................7 2. This Court also lacks specific jurisdiction over plaintiff’s claims .................................8 a. Plaintiff’s claims do not arise out of BMS and AstraZeneca’s California contacts ....................................................................................................................9 b. Plaintiff cannot establish personal jurisdiction over BMS and AstraZeneca by naming a California corporation as a co-defendant ..........................................12 B. In the alternative, this case should be transferred to the Middle District of North Carolina ..............................................................................................................................12 1. This case should be transferred to plaintiff’s home state of North Carolina for the convenience of witnesses and the parties, and to allow a court familiar with controlling law to preside over the case. ..............................................................13 a. Transfer is in the interest of the parties and witnesses. ..........................................13 b. Transfer will serve the interest of justice. ..............................................................16 IV. CONCLUSION ........................................................................................................................18 Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 2 of 24 ii NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 TABLE OF AUTHORITIES Page(s) Cases Action Embroidery Corp. v. Atl. Embroidery, Inc., 368 F.3d 1174 (9th Cir. 2004) .................................................................................................12 In re Air Crash Over the Taiwan Straits on May 25, 2002, 331 F.Supp.2d 1176 (C.D. Cal. 2004) .....................................................................................17 Bauman v. DaimlerChrysler Corp., 644 F.3d 909 (9th Cir. 2011) .....................................................................................................7 Bristol-Myers Squibb Company v. Superior Court, 1 Cal.5th 783 (2016), cert. granted..........................................................................................11 Carlson v. Boston Scientific Co., 2015 WL 5732107 (W.D.N.C. 2015) ......................................................................................14 Cordoza v. T-Mobile U.S.A. Inc., No. 08-5120 SC, 2009 WL 723843 (N.D. Cal. 2009).............................................................12 Costco Wholesale Corp. v. Liberty Mut. Ins. Co., 472 F. Supp. 2d 1183 (S.D. Cal. 2007) ..............................................................................12, 13 Daimler AG v. Bauman 571 U.S. ___, 134 S. Ct. 746 (2014) ..............................................................................1, 4, 7, 8 Data Disc, Inc. v. Systems Tech. Assocs., Inc., 557 F.2d 1280 (9th Cir. 1977) .................................................................................................11 Decker Coal Co. v. Commonwealth Edison Co., 805 F.2d 834 (9th Cir. 1986) ...................................................................................................13 Fabus Corp. v. Asiana Exp. Corp., No. C-00-3172 PJH, 2001 WL 253185 (N.D. Cal. 2001) .......................................................17 Flotsam of Cal., Inc. v. Huntington Beach Conf. & Visitors Bureau, No. C 06-7028 MMC, 2007 WL 1152682 (N.D. Cal. Apr. 18, 2007) ....................................13 Genuine Parts Co. v. Cepec, 137 A.3d 123 (Del. 2016) ..........................................................................................................8 Goodyear Dunlop Tires Operations, S.A. v. Brown 131 S. Ct. 2846 (2011) .....................................................................................................7, 8, 10 Grossman v. Johnson & Johnson, 2015 WL 1743116 (N.D. Cal. 2015) .................................................................................14, 15 Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 3 of 24 iii NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Gulf Oil Corp. v. Gilbert, 330 U.S. 501 (1947), superseded by statute on other grounds ....................................15, 16, 17 Helicopteros Nacionales de Colombia, S.A. v. Hall 466 U.S. 408(1984) ....................................................................................................................9 Jones v. GNC Franchising, Inc., 211 F.3d 495 (9th Cir. 2000) ...................................................................................................13 Menken v. Emm, 503 F.3d 1050 (9th Cir. 2007) ...........................................................................................1, 4, 9 Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004) ...................................................................................................14 Panavision Int’l, L.P. v. Toeppen, 141 F.3d 1316 (9th Cir. 1998) ...................................................................................................7 Prime Healthcare Centinela, LLC, et al. v. Kimberly-Clark Corporation, 2016 WL 7177532 (C.D. Cal. 2016) ........................................................................................12 Rio Props., Inc. v. Rio Int’l Interlink, 284 F.3d 1007 (9th Cir. 2002) ...................................................................................................7 Royal Queentex Enterprises v. Sara Lee Corp., No. C-99-4787 MJ, 2000 WL 246599 (N.D. Cal. 2000) ........................................................17 Saleh v. Titan Corp., 361 F. Supp. 2d 1152 (S.D. Cal. 2005) ....................................................................................13 Schwarzenegger v. Fred Martin Motor Co., 374 F.3d 797 (9th Cir. 2004) .....................................................................................................9 Securities Investor Protection Corp. v. Vigman, 764 F.2d 1309 (9th Cir. 1985) .................................................................................................13 Stanley v. Novartis Pharmaceuticals Corp., 11 F. Supp. 3d 987, 1002 (C.D. Cal. 2014) .............................................................................14 Sullivan v. Ford Motor Co., No. 16-cv-03505-JST, 2016 WL 6520174 (N.D. Cal. Nov. 3, 2016) ......................................11 Van Schijndel v. Boeing Co., 434 F.Supp.2d 766 (N.D. Cal. 2006) .......................................................................................15 Walden v. Fiore 134 S.Ct. 1115 (2014) ................................................................................................................8 Watkins v. Sowders, 449 U.S. 341 (1981) .................................................................................................................15 Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 4 of 24 iv NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 World-Wide Volkswagen Corp. v. Woodson 444 U.S. 286 (1980) .........................................................................................................8, 9, 12 Statutes 28 U.S.C. ..........................................................................................................................................1 28 U.S.C. § 1404(a) ............................................................................................................... passim Cal. Civ. Proc. Code § 410.10 .........................................................................................................7 Other Authorities Wright, 15 Fed. Prac. & Proc. Juris. 3854 (3d ed.) ........................................................................16 Fourteenth Amendment ...................................................................................................................6 Fed.R.Civ.P. 4(k)(1)(A) ...................................................................................................................7 Fed.R.Civ.P., Rule 12(b)(2) .............................................................................................................1 U.S. Const. amend. XIV ..................................................................................................................7 United States Constitution .............................................................................................................11 15 Wright, Miller & Cooper, Federal Practice & Procedure, § 3854 (3d ed.) ...............................13 Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 5 of 24 1 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 TO THE COURT, ALL PARTIES AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on July 6, 2017 at 2:00 p.m., in Courtroom 9 of the United States District Court, Northern District of California, located at 450 Golden Gate, 19th Floor, San Francisco, California 94102, Defendants AstraZeneca Pharmaceuticals LP (AstraZeneca) and Bristol-Myers Squibb Company (BMS) will, and hereby do, move the Court to dismiss plaintiff Anita Rochelle Holland’s complaint pursuant to Federal Rules of Civil Procedure, Rule 12(b)(2). The bases for this motion to dismiss for lack of personal jurisdiction are as follows: This Court lacks general jurisdiction over BMS and AstraZeneca because neither BMS nor AstraZeneca are “at home” in California. See Daimler AG v. Bauman 571 U.S. ___, 134 S. Ct. 746 (2014). BMS is a Delaware corporation with its principal place of business in New York, New York. AstraZeneca is a Delaware limited partnership with its principal place of business in Wilmington, Delaware. Neither BMS nor AstraZeneca has ever been incorporated or organized under the laws of California or maintained its principal place of business here. This Court lacks specific jurisdiction over BMS and AstraZeneca because plaintiff’s claims do not arise from any of their activities within California. The Ninth Circuit interprets the “arising from” requirement for specific jurisdiction to impose a causal connection between a defendant’s forum-state contacts and a plaintiff’s claims. Under this standard, a defendant’s forum-state contacts must be the “but for” cause of a plaintiff’s injuries. See Menken v. Emm, 503 F.3d 1050, 1058 (9th Cir. 2007). Plaintiff does not allege that she was prescribed the drugs at issue (Onglyza and Kombiglyze) in California, that she ingested either drug in California, or that she suffered any injury in California. Thus, her alleged ingestion and injury would still have occurred even if the contacts of BMS and AstraZeneca with California never existed. Accordingly, this Court should dismiss plaintiff’s complaint against BMS and AstraZeneca. In the alternative, AstraZeneca, BMS, and McKesson Corporation (McKesson) move for an order transferring plaintiff’s case pursuant to 28 U.S.C. § 1404(a) to the United States District Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 6 of 24 2 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Court for the Middle District of North Carolina, which is the judicial district where plaintiff resided at the time of her alleged treatment and injury. The bases for this motion to transfer are as follows: The case involves one plaintiff who resides in North Carolina. Plaintiff has no connection to the Northern District of California. She alleges she sought treatment, was prescribed Onglyza, ingested Onglyza, and was injured in North Carolina. Thus, the documents, records, and witnesses (including plaintiff’s prescribing and treating doctors) relevant to plaintiff’s claims are located in North Carolina. As the events giving rise to plaintiff’s claims occurred in North Carolina, each cause of action will be governed by North Carolina law. The interests of justice and judicial efficiency strongly favor this Court transferring this case so that it might be litigated in the judicial district where plaintiff resides. Such transfer would conserve judicial resources and avoid inconsistent rulings by ensuring that plaintiff’s case is litigated in a court familiar with governing law, near the relevant documents, and with subpoena power over the critical non-party witnesses. For these reasons, a California court recently granted forum non conveniens motions under a substantially similar standard as 28 U.S.C. § 1404(a) in two Onglyza® cases filed by the same plaintiffs’ counsel and which alleged similar injuries and claims as in the instant action. Given the early stage of this case, trial will in no way be hindered or delayed if the case is transferred at this time to the appropriate district court. Rather, transfer at this point will result in significant discovery and case management benefits through reduced costs and easier access to evidence. Accordingly, this Court should transfer plaintiff’s case to the Middle District of North Carolina. Such a ruling would benefit the courts, parties, and witnesses, and would further the interest of justice. This motion is based on this Notice of Motion; the accompanying Memorandum in Support of the Motion; the accompanying Declaration of William E. Steimle; the Court’s records and files in this case; and any evidence received at the hearing. Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 7 of 24 3 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 DATED: May 26, 2017 KING & SPALDING LLP By: /s/ William E. Steimle ________________ DONALD F. ZIMMER, JR. WILLIAM E. STEIMLE Attorneys for Defendants BRISTOL-MYERS SQUIBB COMPANY; ASTRAZENECA PHARMACEUTICALS LP; AND MCKESSON CORPORATION Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 8 of 24 4 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 MEMORANDUM OF POINTS AND AUTHORITIES I. INTRODUCTION This Court lacks personal jurisdiction because AstraZeneca Pharmaceuticals LP (AstraZeneca) and Bristol-Myers Squibb Company (BMS) are both out-of-state defendants and plaintiff Anita Rochelle Holland’s claims do not arise from Defendants’ conduct within California. This Court lacks general personal jurisdiction over BMS and AstraZeneca because neither defendant is “at home” in California. In Daimler AG v. Bauman, the Supreme Court of the United States held that continuous and systematic contacts with a state are not sufficient for general jurisdiction. Rather, general jurisdiction is proper over a company only in the state where that company is “at home.” Absent extraordinary circumstances not present here, a company is “at home” only where it is incorporated or maintains its principal place of business. BMS is a Delaware corporation with its principal place of business in New York, New York. AstraZeneca is a Delaware limited partnership with its principal place of business in Wilmington, Delaware. None of AstraZeneca’s limited or general partners are domiciled in California, and the Complaint makes no allegation otherwise. Neither BMS nor AstraZeneca has ever been incorporated or organized in California or maintained its principal place of business here. This Court also lacks specific jurisdiction over BMS and AstraZeneca because plaintiff’s claims do not arise from any of their activities within California. The Ninth Circuit interprets the “arising from” requirement for specific jurisdiction to require a causal connection between a defendant’s forum-state contacts and a plaintiff’s claims. See Menken v. Emm, 503 F.3d 1050, 1058 (9th Cir. 2007). Under this standard, a defendant’s forum-state contacts must be the “but for” cause of a plaintiff’s injuries. Ibid. Plaintiff does not allege that she was prescribed the drugs at issue (Onglyza and Kombiglyze) in California, that she ingested either drug in California, or that she suffered any injury in California. She alleges no causal connection between any alleged California activity and her injury. Instead, plaintiff appears to believe jurisdiction is proper simply because BMS and AstraZeneca conduct business in California. Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 9 of 24 5 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 But conducting business in a state without any causal connection between the in-state activities and allegations in the lawsuit is not enough to confer jurisdiction over an out-of-state defendant. Nor may plaintiff create jurisdiction over BMS and AstraZeneca by naming McKesson as a co- defendant. Personal jurisdiction must be established for each defendant and for the claims of each plaintiff. When the plaintiff, the defendant, the injury, and the alleged conduct giving rise to it are all outside of California, a California court has no jurisdiction over the claim. In the alternative, BMS, AstraZeneca, and McKesson (collectively, Defendants) move to transfer this case to the United States District Court for the Middle District of North Carolina because plaintiff resides in North Carolina and has no connection with the Northern District of California.1 Transfer of this case to the jurisdiction of plaintiff’s residence will ensure that the case is heard in a district court that is familiar with the governing state law, and that is located where the relevant documents, records, and witnesses-including plaintiff and her individual prescribing and treating doctors-actually reside. On these grounds, a California court granted forum non conveniens motions under a substantially similar standard as 28 U.S.C. § 1404(a) in two Onglyza® cases filed by the same plaintiffs’ counsel and which alleged similar injuries and claims as in the instant action.2 Other plaintiffs in California state court who are represented by the same counsel as here also agreed to dismiss non-resident-plaintiffs subsequent to the California court’s FNC ruling.3 Despite this, counsel for plaintiff continues to file cases involving non-resident defendants in the Northern District of California. Because transfer is appropriate under relevant federal law and is in the best interest of the Court and parties, Defendants respectfully request that this Court transfer this case to the Middle District of North Carolina in the event this Court denies Defendant’s motion to dismiss. II. BACKGROUND Plaintiff Anita Rochelle Holland is a citizen and resident of North Carolina. See 1 Plaintiff’s complaint does not identify her county of residence. Defendants allege upon information and belief that plaintiff resides in Rowan County-thus, the Middle District of North Carolina is the proper venue for her claims. 2 See Exhibit B to the Declaration of William E. Steimle (Steimle Decl.). 3 Steimle Decl., Ex. C. Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 10 of 24 6 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Complaint, Steimle Decl., Ex. A, ¶ 7. Plaintiff’s Complaint-filed on April 27, 2017-alleges that she was damaged as a result of alleged treatment with Onglyza or Kombiglyze XR, drugs that are FDA-approved to treat type-2 diabetes mellitus. While she filed her claims in California, she does not allege any connection to the state. The Complaint alleges that “Defendant Bristol-Myers Squibb Company (“BMS”) is a Delaware corporation with its principal place of business at 345 Park Ave., New York, NY, 10154,” and that “Defendant AstraZeneca Pharmaceuticals LP (“AZ”) is a Delaware limited partnership with its principal place of business at 1800 Concord Pike, Wilmington, DE 19850.” Steimle Decl., Ex. A, ¶¶ 9,10. 4 Plaintiff also names McKesson Corporation, a Delaware corporation with its principal place of business in San Francisco, California as a defendant. Id. at ¶ 11. In asserting that personal jurisdiction exists over BMS and AstraZeneca, the Complaint alleges that BMS and AstraZeneca “conducted business and derived substantial revenue from its manufacturing, advertising, distributing, selling, and marketing of [Onglyza and Kombiglyze] within the state of California.” Id. at ¶¶ 9-10. Plaintiff asserts that BMS and AstraZeneca are “authorized to conduct or engage in business within the State of California” and that jurisdiction exists over both entities because they “committed a tort in whole or in part in the state of California and have regular and continuing contacts with California.” Id. at ¶¶ 16, 20. However, the complaint does not allege a causal relationship between these alleged activities of BMS and AstraZeneca in California and plaintiff’s claimed injury that occurred in North Carolina. III. ARGUMENT A. Personal jurisdiction exists only in a forum where the defendant is “at home” or where a defendant’s contacts with the forum are the cause of the plaintiff’s injuries The Fourteenth Amendment provides that “[n]o state shall . . . deprive any person of 4 AstraZeneca notes that none of its limited or general partners are domiciled in California, and the Complaint makes no allegation otherwise. Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 11 of 24 7 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 life, liberty, or property, without due process of law.” (U.S. Const. amend. XIV.) “A state court’s assertion of jurisdiction exposes defendants to the State’s coercive power, and is therefore subject to review for compatibility with the” Due Process Clause, which “sets the outer boundaries of a state tribunal’s authority to proceed against a defendant.” Goodyear Dunlop Tires Operations, S.A. v. Brown 131 S. Ct. 2846, 2850, 2853 (2011). When there is no applicable federal statute governing personal jurisdiction, as here, the district court applies the law of the state in which the district court sits. See Fed.R.Civ.P. 4(k)(1)(A); Panavision Int'l, L.P. v. Toeppen, 141 F.3d 1316, 1320 (9th Cir. 1998). The California long-arm statute “permits the exercise of personal jurisdiction to the full extent permitted by due process.” Bauman v. DaimlerChrysler Corp., 644 F.3d 909, 919 (9th Cir. 2011) (quoting Bancroft & Masters, Inc. v. Augusta Nat. Inc., 223 F.3d 1082, 1086 (9th Cir. 2000), rev’d on other grounds by Daimler AG v. Bauman 134 S. Ct. 746, 754 (2014); see Cal. Civ. Proc. Code § 410.10 (“A court of this state may exercise jurisdiction on any basis not inconsistent with the Constitution of this state or of the United States.”) The United States Supreme Court has identified two categories of personal jurisdiction: “general or all-purpose jurisdiction, and specific or conduct-linked jurisdiction.” Daimler, 134 S. Ct. at 751. Plaintiff cannot meet her burden of establishing facts showing the proper exercise of jurisdiction under either category. See Rio Props., Inc. v. Rio Int’l Interlink, 284 F.3d 1007, 1019 (9th Cir. 2002) (Although the defendant is the moving party on a motion to dismiss [for lack of personal jurisdiction], the plaintiff bears the burden of establishing that jurisdiction exists.”) 1. The Supreme Court’s decisions in Goodyear and Daimler foreclose general jurisdiction over BMS and AstraZeneca because they are not at home in California In Goodyear and Daimler, the U.S. Supreme Court held that a corporation normally is subject to general jurisdiction only in the states where it is incorporated or maintains its principal place of business. It is not enough that a corporation conducts business-even substantial business-within a given state. Rather, the corporation’s contacts with the state Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 12 of 24 8 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 must rise to a level that renders it essentially “at home” there. Daimler, supra, 134 S. Ct. at 761. BMS and AstraZeneca are not incorporated or organized under the laws of California, neither maintains its principal place of business here, and plaintiffs do not contend otherwise. See Complaint, Steimle Decl., Ex. A, ¶¶ 9-11. After Goodyear and Daimler, that is enough to foreclose general jurisdiction. While BMS and AstraZeneca conduct business in all fifty states, a company “that operates in many places can scarcely be deemed at home in all of them.” Daimler, supra, 134 S. Ct. at 762 n.20; see also Genuine Parts Co. v. Cepec, 137 A.3d 123, 143-144 (Del. 2016) (“Daimler rejected the notion that a corporation that does business in many states can be subject to general jurisdiction in all of them.”) If simply conducting business within a state were enough for general jurisdiction, then a plaintiff could sue “in every State in which a corporation engages in a substantial, continuous, and systematic course of business.” Daimler, supra, 134 S. Ct. at 761. But the Daimler Court rejected that result and its underlying theory as “unacceptably grasping.” Ibid. 2. This Court also lacks specific jurisdiction over plaintiff’s claims The Due Process Clause also prohibits this Court from exercising specific jurisdiction over plaintiff’s claims. Specific jurisdiction is appropriate only when “the suit ‘aris[es] out of or relate[s] to the defendant’s contacts with the forum.’” Daimler, supra, 134 S. Ct. at p. 754 (quoting Helicopteros Nacionales de Colombia, S.A. v. Hall (1984) 466 U.S. 408, 414 n.8). “Due process limits on the State’s adjudicative authority principally protect the liberty of the nonresident defendant-not the convenience of plaintiffs or third parties.” Walden v. Fiore 134 S.Ct. 1115, 1122 (2014). These limits are necessary to “ensure that the States through their courts, do not reach out beyond the limits imposed on them by their status as coequal sovereigns in a federal system.” World-Wide Volkswagen Corp. v. Woodson 444 U.S. 286, 292 (1980). “‘[T]he Framers . . . intended that the States retain many essential attributes of sovereignty, including, in particular, the sovereign power to try causes in their courts. The sovereignty of each State, in turn, implied a limitation on the sovereignty of all of its sister States.’” Id. at 293. The United States Supreme Court has “never accepted the proposition that state lines are Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 13 of 24 9 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 irrelevant for jurisdictional purposes, nor could we, and remain faithful to the principles of interstate federalism embodied in the Constitution.” Ibid. Thus, “‘the relationship among the defendant, the forum, and the litigation’ is the essential foundation” of personal jurisdiction. Helicopteros, supra, 466 U.S. at 414 (quoting Shaffer v. Heitner (1977) 433 U.S. 186, 204). Courts in the Ninth Circuit apply a three-part test to determine whether a district court may exercise specific personal jurisdiction over a nonresident defendant: 1) Did the non-resident defendant “purposefully direct” its activities to the forum or a resident of the forum state, or perform some act by which it “purposefully availed” itself of “the privilege of conducting activities in the forum, thereby invoking the benefits and protections of its laws?” 2) Does the claim “arise[] out of or relate[] to the defendant’s forum-related activities?” 3) Would the exercise of jurisdiction “comport with fair play and substantial justice (in other words, would it be reasonable)?” Schwarzenegger v. Fred Martin Motor Co., 374 F.3d 797, 802 (9th Cir. 2004) (quoting Lake v. Lake, 817 F.2d 1416, 1421 (9th Cir. 1987); see also Menken, supra, 503 F.3d at 1057. “The plaintiff bears the burden of satisfying the first two prongs of the test.” Schwarzenegger, 374 F.3d at 802. “If the plaintiff succeeds in satisfying both of the first two prongs, the burden then shifts to the defendant to ‘present a compelling case’ that the exercise of jurisdiction would not be reasonable.” Ibid. (quoting Burger King Corp. v. Rudzewicz, 471 U.S. 462, 477 (1985)). a. Plaintiff’s claims do not arise out of BMS and AstraZeneca’s California contacts Plaintiff cannot meet the Ninth Circuit’s “arising from” standard because she has not alleged and cannot demonstrate that activities by AstraZeneca and BMS in California caused her alleged injury in North Carolina. Under Ninth Circuit law, plaintiff must show that “but for” the actions of BMS and AstraZeneca in California, she would not have been injured. See Menken, 503 F.3d at 1058. She cannot do so. Plaintiff does not live in California and does not Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 14 of 24 10 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 allege that she was injured in California. Moreover, litigation over these claims depends on plaintiff’s ability to prove medical and legal causation linking her physician’s prescribing decisions to her claimed damages-all of which occurred outside California. There is no connection between any actions of AstraZeneca and BMS in California and the Onglyza prescription, ingestion, and alleged injury in North Carolina. Thus, plaintiff cannot prove that “but for” defendants actions in California, she would not have been injured. Stated another way, plaintiff’s claims would have been exactly the same even if AstraZeneca and BMS had no contacts with California. The United States Supreme Court’s decision in Goodyear clarifies that sales in the forum of some products made by the defendant do not subject it to specific jurisdiction for claims as to products that were sold and allegedly caused injury elsewhere. In Goodyear, North Carolina plaintiffs filed suit at home against three foreign subsidiaries of The Goodyear Tire and Rubber Company, alleging that a defective tire made by the subsidiary in Turkey caused a fatal bus accident in France. Goodyear, supra, 564 U.S. at 918. Tens of thousands of their tires were distributed in North Carolina through a “highly-organized distribution process” by other Goodyear affiliates. Id. at 921-922. The particular type of tire involved in the accident was not sold in North Carolina, but the very tire involved in the accident conformed to U.S. government standards and bore markings required for sale in the U.S. Ibid. The Goodyear opinion explained that North Carolina lacked specific jurisdiction for reasons that are indistinguishable here: Because the episode-in-suit, the bus accident, occurred in France, and the tire alleged to have caused the accident was manufactured and sold abroad, North Carolina courts lacked specific jurisdiction to adjudicate the controversy. Goodyear, supra, 564 U.S. at 919. Applying Goodyear, there is no specific jurisdiction in California over the claims by the plaintiff here because the alleged injury here occurred in North Carolina, and the prescription, sale, and ingestion of Onglyza occurred in North Carolina. Accordingly, California courts lack specific jurisdiction to adjudicate this case. Plaintiff likely will attempt to rely on the California Supreme Court’s recent decision in Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 15 of 24 11 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Bristol-Myers Squibb Company v. Superior Court, 1 Cal.5th 783 (2016), cert. granted. This opinion of the California Supreme Court is not binding on this Court. Under Ninth Circuit law, “federal law is controlling on the issue of due process under the United States Constitution” and “[w]e are not bound by state cases.” Data Disc, Inc. v. Systems Tech. Assocs., Inc., 557 F.2d 1280, 1286 n.3 (9th Cir. 1977); see also Sullivan v. Ford Motor Co., No. 16-cv-03505-JST, 2016 WL 6520174, at *3 (N.D. Cal. Nov. 3, 2016) (declining to follow the California Supreme Court’s opinion in Bristol-Myers for that reason). Furthermore, it cannot guide the Court’s analysis of the issue on this motion because it conflicts with the Ninth Circuit’s causal “arising from” standard, which is binding authority in this case. Moreover, the continued viability of the Bristol-Myers opinion - even in California - is not certain. The Supreme Court has granted certiorari to review the decision. Oral arguments occurred on April 25, 2017, and a decision is anticipated by June 2017. Dkt. No. 16-466. To the extent the Court is persuaded by Plaintiff’s anticipated argument that the Bristol-Myers case supports a finding of jurisdiction here, Defendants respectfully ask the Court to hold its decision in abeyance until after the US Supreme Court has had a chance to issue its order and clarify the scope of specific jurisdiction. The California Supreme Court in Bristol-Myers loosened the “arising from” requirement- which is supposed to distinguish specific from general jurisdiction-to the point where specific jurisdiction is no longer specific to the plaintiff’s claim and is really general jurisdiction by another name. This result directly contradicts controlling Ninth Circuit authority and cannot be followed here. Finally, BMS and AstraZeneca anticipate that plaintiff may argue that, because they conducted clinical trials in California (as they did in several states), they are somehow subject to suit here. There is no allegation, however, that plaintiff’s claims for relief “arise out of” those clinical trials. And, in fact, they do not. Specific jurisdiction must not be morphed into “unacceptably grasping” jurisdiction as a vehicle for one State to seize jurisdiction over a host of individual personal-injury claims gathered from across the country. Rather, limits on jurisdiction “ensure that the States through their courts, do not reach out beyond the limits imposed on them by their status as coequal Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 16 of 24 12 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 sovereigns in a federal system.” World-Wide Volkswagen, supra, 444 U.S. at 292-294. “They are a consequence of territorial limitations on the power of the respective States.” Hanson, supra, 357 U.S. at 250-251. The courts of California are not national tribunals, and California’s jurisdiction does not extend to extraterritorial claims brought by an out-of-state plaintiff against out-of-state Defendants over injuries that occurred out-of-state. b. Plaintiff cannot establish personal jurisdiction over BMS and AstraZeneca by naming a California corporation as a co- defendant Plaintiff may not establish personal jurisdiction over BMS and AstraZeneca by naming McKesson Corporation-a California-based company and alleged distributor of the drug at issue-as a co-defendant. Indeed, “[p]ersonal jurisdiction must be established for each defendant and by each plaintiff.” Prime Healthcare Centinela, LLC, et al. v. Kimberly-Clark Corporation, 2016 WL 7177532, at *1 (C.D. Cal. 2016) (quoting Rutter Group Practice Guide: Federal Civil Procedure Before Trial Ch. 3-E (2016)) (emphasis in original); see also Action Embroidery Corp. v. Atl. Embroidery, Inc., 368 F.3d 1174, 1180 (9th Cir. 2004) (“Personal jurisdiction must exist for each claim asserted against a defendant.”). B. In the alternative, this case should be transferred to the Middle District of North Carolina Defendants alternatively request that this case be transferred to the Middle District of North Carolina. The transfer of a case from one district court to another is appropriate “for the convenience of parties and witnesses, in the interest of justice.” 28 U.S.C. § 1404(a). “The convenience of witnesses is often the most important factor in resolving a motion to transfer.” Cordoza v. T-Mobile U.S.A. Inc., No. 08-5120 SC, 2009 WL 723843, at *4 (N.D. Cal. 2009) (citing Bunker v. Union Pac. R.R. Co., No. 05-4059, 2006 WL 193856, at *2 (N.D. Cal. 2006)). “Convenience of witnesses” includes considering whether any non-party witnesses are outside the reach of the subpoena power of the court, as well as the physical location of any witnesses who will likely provide testimony in a case. Costco Wholesale Corp. v. Liberty Mut. Ins. Co., Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 17 of 24 13 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 472 F. Supp. 2d 1183, 1193 (S.D. Cal. 2007). Generally, the convenience of the witnesses who are not parties to the action is the most important element to consider. Flotsam of Cal., Inc. v. Huntington Beach Conf. & Visitors Bureau, No. C 06-7028 MMC, 2007 WL 1152682, at *3 (N.D. Cal. Apr. 18, 2007); Saleh v. Titan Corp., 361 F. Supp. 2d 1152, 1160 (S.D. Cal. 2005). Finally, a court must consider “not simply how many witnesses each side has and the location of each, but also the importance of the witnesses.” Costco Wholesale Corp., 472 F. Supp. 2d at 1193 (quoting Saleh, 361 F. Supp. 2d at 1165). Other factors for the court to consider as well, include: (1) ease of access to the evidence; (2) familiarity of each forum with the applicable law; (3) feasibility of consolidation of other claims; (4) any local interest in the controversy; (5) relative court congestion and time to trial in each forum; (6) location where the relevant agreements were negotiated and executed; (7) the parties' contacts with the forum; (8) difference in the costs of litigation in the two forums; (9) the availability of compulsory process to compel attendance of unwilling non-party witnesses; and (10) plaintiff's choice of forum. See, e.g., Decker Coal Co. v. Commonwealth Edison Co., 805 F.2d 834, 843 (9th Cir. 1986); Jones v. GNC Franchising, Inc., 211 F.3d 495, 498-99 (9th Cir. 2000); Securities Investor Protection Corp. v. Vigman, 764 F.2d 1309, 1317 (9th Cir. 1985). Courts have also consistently held that the “administration of justice is served more efficiently when the action is litigated in the forum that more clearly encompasses the locus of operative facts.” 15 Wright, Miller & Cooper, Federal Practice & Procedure, § 3854 (3d ed.). 1. This case should be transferred to plaintiff’s home state of North Carolina for the convenience of witnesses and the parties, and to allow a court familiar with controlling law to preside over the case. a. Transfer is in the interest of the parties and witnesses. This Court should transfer plaintiff’s case to the Middle District of North Carolina, where she was prescribed, purchased, and ingested Onglyza, and where she allegedly suffered injury from the drug. Indeed, plaintiff has no connection to the Northern District of California. Similarly, AstraZeneca and BMS have no relevant connection to California, as they are not Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 18 of 24 14 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 residents or citizens of the state of California, relevant company documents are not housed in California, and the potential company witnesses do not reside in California. Counsel for plaintiff has conceded this fact in related cases involving Onglyza in California state court. As discussed above, a California court granted forum non conveniens motions in two Onglyza cases under a substantially similar standard as the one applied here. See Steimle Decl., Ex. B. Despite the California court’s ruling and subsequent stipulations from other plaintiffs in California state court using the same counsel who filed this claim, see Steimle Decl., Ex. C, counsel for plaintiff continues to file cases involving non-resident defendants in the Northern District of California. Transfer of plaintiff’s claims is also appropriate for the convenience of witnesses. Since plaintiff lives in North Carolina, the parties will require discovery from third parties not subject to the subpoena power of this Court. Indeed, the overwhelming majority of key witnesses are located in plaintiff’s home state of North Carolina, including the plaintiff, her family members, co-workers, employers, prescribing doctors, and treating doctors. Among the physicians whose testimony will be crucial are physicians alleged to have prescribed Onglyza to plaintiff, communicated with her about Onglyza, treated her relative to the conditions and alleged injuries at issue, and have knowledge of her medical histories and any pre-existing conditions. See, e.g., Grossman v. Johnson & Johnson, 2015 WL 1743116, at *2, (N.D. Cal. 2015) (transferring pharmaceutical personal injury case to plaintiff’s home state where she did not allege any events directly related to her injuries took place in California and her doctors, including her prescribing physician, and all documents related to her medical, pharmacy, insurance, and employment records were located in her home state). Because the claims at issue center on an alleged failure to warn of risks of Onglyza treatment, the testimony of plaintiff’s treating and prescribing physicians will be critical because any duty to warn runs to the prescribing physicians, who are the learned intermediaries. See Motus v. Pfizer Inc., 358 F.3d 659, 661 (9th Cir. 2004); Stanley v. Novarties Pharmaceuticals Corp., 11 F. Supp. 3d 987, 1002 (C.D. Cal. 2014) (“California follows the learned intermediary doctrine, which provides that in the case of prescription drugs, the duty to warn ‘runs to the physician, not to the patient.’”); Carlson v. Boston Scientific Co., 2015 WL 5732107, at *2 Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 19 of 24 15 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 (W.D.N.C. 2015) (“Although the North Carolina Supreme Court has never expressly ruled on this issue, courts have presumed that the North Carolina Supreme Court would apply the learned intermediary doctrine.”) Thus, the physicians who prescribed the drug to plaintiff, who are outside subpoena power of this Court, are imperative trial witnesses and testimony about what these physicians knew regarding purported risks with Onglyza treatment will be vital to Defendants’ case. Grossman, 2015 WL 1743116, at *2. It also will be important to understand what each treating and prescribing physician told plaintiff about Onglyza, and what materials if any plaintiff was given or otherwise obtained. All of these things would have occurred in North Carolina, not in California. Despite the indisputable significance of all of this evidence, live testimony of these out- of-state physicians and other witnesses will be unavailable to Defendants if trial were to proceed in California, because these witnesses are beyond the subpoena power of this Court. The parties and Court would be left to the generosity of these witnesses to voluntarily travel to California, or a trial replete with deposition testimony would ensue, which courts have maligned for decades. See Gulf Oil Corp. v. Gilbert, 330 U.S. 501, 511 (1947), superseded by statute on other grounds, (“[t]o fix the place of trial at a point where litigants cannot compel personal attendance and may be forced to try their cases on deposition, is to create a condition not satisfactory to court, jury or most litigants.”); see also Van Schijndel v. Boeing Co., 434 F.Supp.2d 766, 779 (N.D. Cal. 2006). Plaintiff may argue that this deposition testimony can be offered at trial by video, but Defendants would be significantly prejudiced if forced to do so. This would force the attorneys to settle for taking an out-of-state deposition that doubles as both a discovery and a cross- examination deposition and then trying to splice together a video to present at trial. The result is an awkward presentation that lacks the force of a live cross-examination and that bears little resemblance to “the time-honored process of cross-examination as the device best suited to determine the trustworthiness of testimonial evidence.” Watkins v. Sowders, 449 U.S. 341, 349 (1981). Moreover, without the ability to compel these witnesses to testify at trial, the defendant cannot question them about any opposing expert opinions disclosed at or near trial or otherwise Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 20 of 24 16 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 tailor their examination to what occurs at trial. Further, transfer of this action will provide easier access to sources of proof. Ms. Holland’s medical records, pharmacy records, employment records, and the alleged improper marketing materials will be located in the jurisdiction in which she resides. As such, document discovery in this case as currently venued will be more difficult, given that the vast majority of doctors, hospitals, and pharmacies who treated plaintiff lie beyond the immediate subpoena power of this Court. If this Court grants the proposed transfer, the local district court will be able to provide plaintiff with access to relevant documents much more efficiently. Any argument that evidence concerning McKesson exists in California somehow tips the analysis plaintiff’s favor is unavailing. Little, if any, evidence on liability and no evidence on damages will exist in California. In fact, the overwhelming majority of the evidence related to liability and damages is in North Carolina or is otherwise at AstraZeneca or BMS facilities outside of California. McKesson is alleged to have distributed the Onglyza at issue in these cases, but any liability for the distribution of Onglyza would be derivative of the liability alleged against the manufacturers, AstraZeneca and BMS. Plaintiff also appears to allege that McKesson promoted Onglyza, warranted it, or made representations about it. She has not alleged, however, that she had any dealings with McKesson or that she relied on anything McKesson said or did. Even if plaintiff or her physicians did have such dealings with McKesson or received any information or representations from McKesson, those activities would have occurred in plaintiff’s home state, not California. b. Transfer will serve the interest of justice. Transfer of this case to plaintiff’s home jurisdiction will also serve the interest of justice by allowing the case to be adjudicated by a court familiar with the governing law of the forum. Indeed, it is preferable to have the court in plaintiff’s home jurisdiction adjudicate these claims: “In diversity of citizenship cases, in which state law provides the substantive rules of decision, it generally is thought to be an advantage in having that law applied by federal judges who are familiar with the governing state law, and thus in trying the case in a district of the state whose law is to govern.” Wright, 15 Fed. Prac. & Proc. Juris. 3854 (3d ed.); see, generally, Gulf Oil, Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 21 of 24 17 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 330 U.S. at 509 (“There is an appropriateness, too, in having the trial of a diversity case in a forum that is at home with the state law that must govern the case, rather than having a court in some other forum untangle problems in conflict of laws, and in law foreign to itself,” discussing transfer via forum non conveniens, rather than via 28 U.S.C. § 1404(a)). Absent transfer, this Court will be required to interpret and apply North Carolina law to plaintiff’s claims. Additionally, this action should not be imposed on jurors in the Northern District of California when this case has no relationship to California. Gulf Oil, 330 U.S. at 508-509 (case “ought not to be imposed upon the people of a community which has no relation to the litigation.”); see also In re Air Crash Over the Taiwan Straits on May 25, 2002, 331 F.Supp.2d 1176, 1206 (C.D. Cal. 2004). California jurors should not be pulled away from their families and places of business to hear the claims of a non-resident plaintiff, who has no relationship to California. Id. California jurors are not a captive audience, waiting to decide disputes for citizens from other states. The burden of jury duty is a heavy one “that ought not be imposed upon the people of a community which has no relation to the litigation.” Gulf Oil, 330 U.S. at 509. While Defendants anticipate plaintiff will argue that her choice of forum should be accorded deference, this argument is misplaced. While it is indeed true that a plaintiff's choice of forum is generally afforded substantial weight, “[t]he degree to which courts defer to the plaintiff's chosen venue is substantially reduced where the plaintiff's venue choice is not its residence or where the forum chosen lacks a significant connection to the activities alleged in the complaint.” Fabus Corp. v. Asiana Exp. Corp., No. C-00-3172 PJH, 2001 WL 253185, at *1 (N.D. Cal. 2001). Moreover, plaintiff's choice will be accorded little deference if there is any indication of forum shopping. See Royal Queentex Enterprises v. Sara Lee Corp., No. C-99- 4787 MJ, 2000 WL 246599, at *3 (N.D. Cal. 2000) (citing Mission Ins. Co. v. Purina Fashions Corp., 706 F.2d 599, 602 n. 3 (5th Cir. 1983)). Plaintiff here is not a resident of California and the events giving rise to her complaint occurred in her home state of North Carolina, not California. Because there is an insufficient connection to the state of California, plaintiff’s choice of forum should be given little, if any, deference. Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 22 of 24 18 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Finally, given the early stage of this case, plaintiff will not be prejudiced, and trial will not be delayed, if the case is transferred now. IV. CONCLUSION For the foregoing reasons, BMS and AstraZeneca request that this Court dismiss Plaintiff’s complaint as against them. In the alternative, Defendants respectfully request that this Court grant their motion to transfer plaintiff’s case pursuant to 28 U.S.C. § 1404(a). DATED: May 26, 2017 KING & SPALDING LLP By: /s/ William E. Steimle ________________ DONALD F. ZIMMER, JR. WILLIAM E. STEIMLE Attorneys for Defendants BRISTOL-MYERS SQUIBB COMPANY; ASTRAZENECA PHARMACEUTICALS LP; AND MCKESSON CORPORATION Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 23 of 24 19 NOTICE OF MOTION AND MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 CERTIFICATE OF SERVICE The undersigned counsel for Defendants BRISTOL-MYERS SQUIBB COMPANY; ASTRAZENECA PHARMACEUTICALS LP; and MCKESSON CORPORATION hereby certifies that a true and correct copy of the foregoing document was filed with the Court and served electronically through the CM-ECF (electronic case filing) system to all counsel of record to those registered to receive a Notice of Electronic Filing for this case on May 26, 2017. /s/ William E. Steimle WILLIAM E. STEIMLE Attorney for Defendants BRISTOL-MYERS SQUIBB COMPANY; ASTRAZENECA PHARMACEUTICALS LP; and MCKESSON CORPORATION Case 3:17-cv-02430-JST Document 16 Filed 05/26/17 Page 24 of 24 DECLARATION OF WILLIAM E. STEIMLE IN SUPPORT OF MOTION TO DISMISS MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 DONALD F. ZIMMER, JR. (Bar No. 112279) fzimmer@kslaw.com WILLIAM E. STEIMLE (Bar No. 203426) wsteimle@kslaw.com KING & SPALDING LLP 101 Second Street, Suite 2300 San Francisco, CA 94105 Telephone: +1 415 318 1200 Facsimile: +1 415 318 1300 Attorneys for Defendants BRISTOL-MYERS SQUIBB COMPANY; ASTRAZENECA PHARMACEUTICALS LP; and MCKESSON CORPORATION IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA ANITA ROCHELLE HOLLAND, Plaintiff, v. BRISTOL-MYERS SQUIBB COMPANY; ASTRAZENECA PHARMACEUTICALS LP; and McKESSON CORPORATION Defendants. Case No. 3:17-cv-02430-JST DECLARATION OF WILLIAM E. STEIMLE IN SUPPORT OF MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION (FRCP 12(B)(2)) OR, IN THE ALTERNATIVE, TO TRANSFER (28 U.S.C. § 1404(A)) Date: July 6, 2017 Time: 2:00 p.m. Judge: Hon. Jon S. Tigar Courtroom: 9 I, William E. Steimle, declare as follows: 1. I am an attorney duly licensed to practice law before all courts of the State of California and the U.S. District Court for the Northern District of California and am one of the attorneys of record for AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, and McKesson Corporation (collectively, Defendants). I have reviewed the file and am familiar Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 1 of 42 2 DECLARATION OF WILLIAM E. STEIMLE IN SUPPORT OF MOTION TO DISMISS MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 with its contents, and as such I have personal knowledge of the facts set forth herein. I make this declaration in support of Motion to Dismiss for Lack of Personal Jurisdiction or, in the Alternative, Motion to Transfer.. 2. Attached hereto as Exhibit A is a true and correct copy of plaintiffs’ complaint. 3. Attached hereto as Exhibit B is a true and correct copy of the Order Denying Motion to Quash for Lack of Personal Jurisdiction and Granting Motion to Dismiss for Forum Non Conveniens, entered October 4, 2016 in Carolyn Williams, et al. v. Bristol-Myers Squibb Company, et al, San Francisco Superior Court No. CGC-16-550418; and Donald Leedy, et al. v. Bristol-Myers Squibb Company, et al, San Francisco Superior Court No. CGC-16-552157. Plaintiffs in those actions, who are not California residents, made similar allegations of injury relating to their alleged use of Onglyza as are at issue in this case. 4. Attached hereto as Exhibit C is a true and correct copy of the Order of Dismissal of Non-California-Resident Plaintiffs, entered January 30, 2017 in John Okoye, et al. v. Bristol- Myers Squibb Company, et al, San Francisco Superior Court No. CGC-16-553662; Louis Hosek, et al. v. Bristol-Myers Squibb Company, et al, San Francisco Superior Court No. CGC-16- 554603; and Michael Martin, et al. v. Bristol-Myers Squibb Company, et al, San Francisco Superior Court No. CGC-16-554610. In these actions, plaintiffs represented by the same plaintiffs’ counsel here stipulated to the dismissal of the non-California-resident plaintiffs. I declare under penalty of perjury under the laws of the United States and the State of California that the foregoing is true and correct. Executed this 26th day of May, 2017, in San Francisco, California. By: /s/ William E. Steimle WILLIAM E. STEIMLE Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 2 of 42 3 DECLARATION OF WILLIAM E. STEIMLE IN SUPPORT OF MOTION TO DISMISS MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION OR, IN THE ALTERNATIVE, TO TRANSFER - 3:17-cv-02430-JST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 CERTIFICATE OF SERVICE The undersigned counsel for Defendants McKESSON CORPORATION; BRISTOL- MYERS SQUIBB COMPANY; and ASTRAZENECA PHARMACEUTICALS LP, hereby certifies that a true and correct copy of the foregoing document was filed with the Court and served electronically through the CM-ECF (electronic case filing) system to all counsel of record to those registered to receive a Notice of Electronic Filing for this case on May 26, 2017. /s/ William E. Steimle WILLIAM E. STEIMLE Attorney for Defendants McKESSON CORPORATION; BRISTOL- MYERS SQUIBB COMPANY; and ASTRAZENECA PHARMACEUTICALS LP Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 3 of 42 EXHIBIT A Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 4 of 42 Case 3:17-cv-02430-]CS Document 1 Filed 04/27/17 Page 1 of 25 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFONIA ANITA ROCHELLE HOLLAND, Case No.: Plaintiff, v. COMPLAINT FOR DAMAGES BRISTOL-MYERS SQUIBB COMPANY; ASTRAZENECA PHARMACEUTICALS LP; MCKESSON CORPORATION; Defendants JURY TRIAL DEMANDED COMES NOW Plaintiff and alleges against Defendants Bristol-Myers Squibb Company, AstraZeneca Pharmaceuticals, LP, and McKesson Corporation as follows: I. INTRODUCTION I. This is an action for damages relating to the Defendants’ design, manufacture, sale, marketing, advertising, promotion, labeling, packaging, and distribution of their drug Saxagliptin. Defendants sell their Saxagliptin drug under the brand names Onglyza and Kombiglyze XR. Saxagliptin, in any of its forms or products, including Onglyza and Kombiglyze XR, shall herein be referred to as “Saxagliptin.” 2. Saxagliptin is prescribed to help lower blood sugar levels in persons with type 2 diabetes mellitus. 3. The use of Saxagliptin can cause heart failure, congestive heart failure, cardiac failure, death from heart failure, and other serious health conditions. 4. Plaintiff ingested Saxagliptin, and as a result of use of the drug suffered injuries. 1 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 5 of 42 Case 3:17-cv-02430-]CS Document 1 Piled 04/27/17 Page 2 of 25 II. GENERAL ALLEGATIONS 5. Plaintiff, Anita Rochelle Holland (“Plaintiff’), by and through Plaintiffs attorneys, Sanders Phillips Grossman, LLC, brings this action for personal injuries suffered as a result of being prescribed and ingesting the defective and unreasonably dangerous prescription drug(s) Onglyza and/or Kombiglyze XR. 6. Onglyza and Kombiglyze XR are prescribed to help lower blood sugar levels in persons with type 2 diabetes mellitus, and at all times relevant hereto, were manufactured, designed, tested, packaged, labeled, marketed, advertised, promoted, distributed, and sold by Defendants Bristol-Meyers Squibb Company, AstraZeneca Pharmaceuticals LP, and McKesson Corporation (collectively “Defendants”). On information and belief, Plaintiff ingested Saxagliptin resulting in injuries. III. PARTIES 7. At all times relevant to this action, Plaintiff, was an individual, citizen and resident of North Carolina. 8. Plaintiff ingested Saxagliptin from approximately November 2012 to September 2014, resulting in injuries. 9. Defendant Bristol-Myers Squibb Company (“BMS”) is a Delaware corporation with its principal place of business at 345 Park Ave., New York, NY 101 54. At all relevant times, BMS has conducted business and derived substantial revenue from its manufacturing, advertising, distributing, selling and marketing of Saxagliptin within the state of California. 10. Defendant AstraZeneca Pharmaceuticals LP (“AZ”) is a Delaware limited partnership with its principal place of business at 1800 Concord Pike, Wilmington, DE 19850. At all relevant times, AZ has conducted business and derived substantial revenue from its manufacturing, advertising, distributing, selling and marketing of Saxagliptin within the state of California. 11. Defendant McKesson Corporation (“McKesson”) is a Delaware corporation with its principal place of business at One Post Street, San Francisco, California 94104. Atall relevant times, McKesson has conducted business and derived substantial revenue from its 2 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 6 of 42 Case 3:17-cv-02430-JCS Document 1 Piled 04/27/17 Page 3 of 25 manufacturing, advertising, distributing, selling and marketing of Saxagliptin within the state of California. 12. Hereinafter the aforementioned Defendants may collectively be referred to as “Defendants.” 13. At all relevant times, each Defendant acted in all aspects as the agent and alter ego of each other. 14. At all relevant times, Defendants acted in concert with one another to fraudulently convey false and misleading information concerning the safety and efficacy of Saxagliptin and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, cardiac failure, death from heart failure and other adverse effects associated with Saxagliptin from the public, Plaintiff, physicians, and other healthcare providers. These concerted efforts resulted in significant harm to those treated with Saxagliptin, including Plaintiff. But for the actions of Defendants, individually, jointly, and in concert with one another, Plaintiff would not have ingested Saxagliptin. 15. At all times alleged herein, Defendants were engaged in the business of, or were successors-in-interest to entities engaged in the business of, researching, designing, formulating, compounding, testing, manufacturing, producing, processing, assembling, inspecting, distributing, marketing, labeling, promoting, packaging, and/or advertising for sale or selling Saxagliptin. 16. At all times alleged herein, Defendants were authorized to conduct or engage in business within the state of California and supplied Saxagliptin within the state of California. Defendants received financial benefit and profits as a result of designing, manufacturing, marketing, advertising, selling and distributing Saxagliptin within the state of California. 17. The combined acts and/or omissions of each Defendant resulted in indivisible injuries to each Plaintiff. Each of the above-named Defendants is a joint tortfeasor and/or co conspirator and is jointly and severally liable to Plaintiff for the negligent acts and omissions alleged herein. Each of the above-named Defendants directed, authorized or ratified the conduct of each and every other Defendant. 3 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 7 of 42 Case 3:17-cv-02430-JCS Document 1 Filed 04/27/17 Page 4 of 25 18. The amount in controversy exceeds the jurisdictional limits of this court. IV. JURISDICTION AND VENUE 19. Jurisdiction is proper in this court pursuant to 28 Usc § 1332 as complete diversity of citizenship exists between Plaintiff and Defendants and the matter in controversy exceeds the sum of $75,000.00, exclusive of interest and costs. 20. This court has jurisdiction over the non-resident Defendants because they have conducted business in the state of California. Defendants have committed a tort in whole or in part in the state of California and have regular and continuing contacts with California. 21. In addition, venue of this case is proper in the state of California pursuant to 28 U.S.C. § 1391 because Defendants reside in the state of California. 22. In addition, venue of this case is proper in the state of California pursuant to 28 U.S.C. § 1391 because a substantial part of the events giving rise to Plaintiffs claims occurred in state of California. V. FACTUAL ALLEGATIONS 23. Type 2 diabetes mellitus is a chronic disease, characterized by insulin resistance and deficient insulin secretion leading to high blood sugar levels and/or hyperglycemia. Type 2 diabetics have an increased risk of cardiovascular disease, which is the leading cause of morbidity and mortality in the patient population. Therefore, it is critical that drugs developed to allegedly help prevent type 2 diabetes do not increase the risk of cardiovascular adverse events in users. With full knowledge of the susceptibility of type 2 diabetics to cardiovascular related adverse events, Defendants developed their drugs Onglyza and Kombiglyze XR to market and sell them to type 2 diabetics to allegedly lower adverse complications associated with type 2 diabetes. 24. Saxagliptin works by inhibiting the proteolytic activity of DPP4, thereby potentiating the action of Glucagon-like peptide-1 (GLP-1), an antihyperglycernic hormone, known as an incretin. This induces glucose-dependent stimulation of insulin secretion while suppressing glucagon secretion, which may help Saxagliptin users lower their HA1c. 4 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 8 of 42 Case 3:17-cv-02430-]CS Document 1 FHeU 04/27/17 Page 5 of 25 25. DPP4 inhibitors, including Saxagliptin, inhibit natural enzymes from cleaving, or stopping, the endogenous GLP-I, which enables the stimulation of insulin to continue longer than what naturally occurs after meals in the postprandial state. Endogenous GLP-l ‘s half-life is approximately two minutes without Saxagliptin exposure, but survives for at least three hours during Saxagliptin exposure. Therefore, Saxagliptin manipulates the natural biological incretin effect by enabling the process to continue for an exponentially greater period of time than what the human body has adapted as a sufficient and safe period of time. At no time during the development of its Saxagliptin drugs did Defendants perform adequate studies to determine if their drug, and its drastic alterations of the natural incretin hormone cycle, may cause increased risks of cardiovascular related adverse events. Such studies are essential when developing, and then marketing, diabetic drugs to individuals already at an increased cardiovascular risk. 26. In December 200$, with knowledge of the increased cardiovascular risk type 2 diabetics suffer from, the FDA issued important guidance regarding this topic to companies developing anti-diabetic drugs, including Defendants. The FDA’s memorandum, entitled final Guidance for Industry, Diabetes Mel/itus. Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes, stated applicants of new anti-diabetic medications for the treatment of type 2 diabetes should demonstrate their products are not associated with an unacceptable increase in cardiovascular risk.1 Despite this guidance being issued during the development of Defendants’ drugs, Defendants failed to perform adequate clinical trials to determine if their drugs created such an increased risk. Instead of adequately assessing the potential, and now established, significant risk of heart failure, congestive heart failure, cardiac failure, and death related to those events, prior to marketing and selling Saxagliptin nationwide to millions of type 2 diabetics, Defendants ignored patient safety and sold Saxagliptin before studying the risks. Defendants marketed and sold Saxagliptin for nearly five years before completing an adequately powered and designed study of the risks of heart failure, congestive heart failure, cardiac failure, and death related to those events. Id. 5 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 9 of 42 Case 3:17-cv-02430-JCS Document 1 Filed 04/27/17 Page 6 of 25 27. On July 31, 2009 Defendants began marketing Onglyza. On November 5,2010, Defendants began marketing Kombiglyze XR. Defendants marketed both drugs as treatments for type 2 diabetes and agents to help reduce adverse complications associated with the disease. At no time did Defendants perform adequate studies or adequately warn that Onglyza and Kombiglyze XR increased the risk of cardiovascular related adverse events. 28. After Defendants began selling and making substantial profits off their drugs Onglyza and Kombiglyze XR, Defendants finally conducted what the FDA guidance recommended back in December 2008 - a Cardiovascular Outcome Trial (“CVOT”) for Saxagliptin. 29. The CVOT for Saxagliptin entitled “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus - Thrombolysis in Myocardial Infarction 53” (SAVOR-TIMI 53 or more simply “SAVOR”) found Saxagliptin users had a statistically significant increased risk of being hospitalized due to heart failure. 30. After receiving and reviewing the disturbing findings from the SAVOR trial, the FDA requested the raw clinical trial data, free from manipulation by Defendants, and performed its own analysis of the SAVOR data. Following the FDA’s detailed analysis and review of the SAVOR safety signal for hospitalization for heart failure, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee convened and voted 14 to I for the FDA to order Defendants to add a heart failure warning to its Saxagliptin drugs. The single member who voted against adding the warning stated a warning was insufficient and the drug should instead be withdrawn from the US market.2 Despite the SAVOR findings and despite the FDA Advisory Committee voting to add a warning (or remove the drugs from the market), Defendants failed and continue to fail to warn. Once again, Defendants place sales over patient safety. 31. In addition to Defendants refusing and failing to warn of the risks of heart failure, congestive heart failure, cardiac failure and death, Defendants’ Saxagliptin drugs lack any 2 Diabetes in Control (April 17, 2015) “FDA Panel Recommends New CV Safety Warnings on Onglyza and Nesina DPP-4s,” available from: hflp://www.diabetesincontrol.com/articles/diabetes-news/1 7836-fda-panel-recommends- new-cv-safety-warnings-on-onglyza-and-nesina-dpp-4s- 6 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 10 of 42 Case 3:17-cv-02430-JCS Document 1 Piled 04/27/17 Page 7 of 25 benefit sufficient to tolerate the risks posed by its use because other anti-diabetes drugs are available that do not carry the increased cardiac risks of Saxagliptin. 32. Defendants, with knowledge of the true relationship between use of Saxagliptin and heart failure, congestive heart failure, cardiac failure, and death related to those events, promoted and continue to promote Saxagliptin as a safe and effective treatment for type 2 diabetes mellitus. 33. Defendants over-promoted Saxagliptin and under-warned about Saxagliptin’s risks through various avenues including, but not limited to, the following: a. in print marketing, advertising, and promotional materials; b. on Defendant-owned, controlled, or supported websites and blogs; c. in materials and advertisements to Plaintiff and consumers stating the use of Saxagliptin is safe; and d. in promoting Saxagliptin to doctors, clinics, and users as being safer than (or as safe as) other drugs for the treatment of type 2 diabetes mellitus. 34. At no time did Defendants perform adequate safety testing on Saxagliptin prior to marketing their drugs to the American public and failed to do so until performing the SAVOR trial. 35. Despite the findings of the SAVOR trial, Defendants still have not undertaken efforts to change the labels and reference materials for Saxagliptin to include a reference or warning regarding heart failure, congestive heart failure, cardiac failure, and death related to those events. IV. PLAINTIFF’S USE OF SAXAGLIPTIN 36. On information and belief, Plaintiff was prescribed and ingested Saxagliptin at various times. 37. On information and belief, Plaintiff used Saxagliptin manufactured, packaged, marketed, sold and/or distributed by Defendants. The Saxagliptin reached Plaintiff without substantial change in the drug’s condition. 7 COMPLMNT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 11 of 42 Case 3:17-cv-02430-]CS Document 1 Filed 04/27/17 Page 8 of 25 38. On information and belief, while using Saxagliptin, and as a direct and proximate result thereof, Plaintiff developed serious and/or permanent adverse effects including but not limited to heart failure, congestive heart failure, and cardiovascular injury. 39. As a result of said injuries, Plaintiff suffered significant bodily and mental injuries, pain and suffering, mental anguish, disfigurement, embarrassment, inconvenience, loss of earnings and eaming capacity and have and will incur past and future medical expenses. 40. At all relevant times, Defendants had knowledge that there was a significant increased risk of adverse events associated with Saxagliptin including heart failure, congestive heart failure, cardiac failure, and death related to those events, and despite this knowledge Defendants continued to manufacture, market, distribute, sell and profit from sales of Saxagliptin. 41. Despite such knowledge, Defendants knowingly, purposely and deliberately failed to adequately warn Plaintiff, patients, consumers, medical providers and the public of the increased risk of serious injury associated with using Saxagliptin including but not limited to heart failure, congestive heart failure, cardiac failure, and death related to those events. 42. On information and belief, Plaintiffs prescribing physicians would not have prescribed Saxagliptinto Plaintiff, would have changed the way in which they treated Plaintiffs relevant conditions, changed the way they warned Plaintiff about the signs and symptoms of serious adverse effects of Saxagliptin, and discussed with Plaintiff the true risks of heart failure, congestive heart failure, cardiac failure, and death related to those events, and other serious adverse events had Defendants provided said physicians with an appropriate and adequate warning regarding the risks associated with the use of Saxagliptin. 43. On information and belief, Plaintiffs prescribing health care providers were unaware of the true degree, incidence, and risk of heart failure, congestive heart failure, cardiac failure, and death related to those events associated with the use of Saxagliptin, and, if they had been informed, would have used and prescribed alternative therapies to Plaintiff. 44. As a direct and proximate result of Defendants’ conduct, Plaintiff suffered injuries, including, but not limited to, heart failure, congestive heart failure, and cardiovascular 8 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 12 of 42 Case 3:17-cv-02430-JCS Document 1 Filed 04/27/17 Page 9 of 25 injury, which resulted in damages to Plaintiff in a sum in excess of the jurisdictional limits of the Court. 45. As a direct and proximate result of Defendants’ conduct, Plaintiff incurred obligations and expenses for medical care, testing and treatment. As a direct and proximate result of Defendants’ conduct, Plaintiff suffered loss of income, wages, profits and commissions, diminishment of earning potential, and other pecuniary losses. 46. Defendants’ conduct was committed with knowing, reckless, conscious, wanton, willful and deliberate disregard for the value of human life and the rights and safety of consumers, including Plaintiff, thereby entitling Plaintiff to punitive and exemplary damages so as to punish and deter similar conduct in the future. V. DELAYED DISCOVERY 47. Defendants, through their affirmative misrepresentations and omissions, actively concealed from the Plaintiff and Plaintiffs physicians and healthcare providers the true and significant risks associated with Saxagliptin. 4$. As a result of Defendants’ actions, Plaintiff and Plaintiffs physicians and healthcare providers were unaware, and could not have reasonably known or have learned through reasonable diligence, that Plaintiff had been exposed to the risks identified in this Complaint, and that those risks were the result of Defendants’ acts, omissions, and misrepresentations. 49. No limitations period ought to accrue until such time as Plaintiff knew or reasonably should have known of some causal connection between the use of Saxagliptin and the harm suffered as a result. As such, Plaintiff hereby invokes the discovery rule based on the fact that this Complaint is filed well within the statutory period after Plaintiff knew or should have known the facts alleged herein. 50. Additionally, the accrual and running of any applicable statute of limitations has been tolled by reason of Defendants’ fraudulent concealment. 9 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 13 of 42 Case 3:17-cv-02430-JCS Document 1 Filed 04/27/17 Page 10 of 25 51. Additionally, each Defendant is equitably estopped from asserting any limitations defense by virtue of its fraudulent concealment and other misconduct as described in this Complaint. CAUSES OF ACTION COUNT I DESIGN DEFECT Plaintiff incorporates by reference each and every paragraph of this Complaint as though set forth in full in this cause of action and further allege: 52. At all relevant and material times, the Defendants designed, manufactured, packaged, marketed, advertised, distributed, and sold Saxagliptin, placing the products into the stream of commerce. 53. At all relevant and material times, Saxagliptin was designed, manufactured, packaged, marketed, advertised, distributed, and sold by Defendants in a defective and unreasonably dangerous condition. 54. Saxagliptin was expected to reach, and did reach, users and consumers, including Plaintiff, without any alterations or changes in their defective and unreasonably dangerous condition. 55. Saxagliptin was used by Plaintiff in the foreseeable manner normally intended, recommended, promoted, and marketed by Defendants. 56. Saxagliptin was defective and unreasonably dangerous when each product entered the stream of commerce in one or more of the following particulars: a. Saxagliptin contained manufacturing and design defects in that the each product caused and/or increased the risk of experiencing an adverse event, including but not limited to heart failure, congestive heart failure, cardiac failure, death from heart failure, and other serious health conditions. b. Saxagliptin was not safe because the health risks associated with each product outweighed the benefits. 10 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 14 of 42 Case 3:17-cv-02430-]CS Document 1 Piled 04/27/17 Page 11 of 25 c. Saxagliptin was marketed and promoted for use when they carried an unreasonable and unnecessary risk of serious injury. d. Saxagliptin was insufficiently and/or inadequately tested by Defendants. e. Saxagliptin was not safe due, in part, to inadequate and defective instructions and inadequate and defective warnings provided by Defendants. f. Saxagliptin was unreasonably dangerous in that, as designed, the risks of serious injury posed by using the products exceeded any benefits the products were designed to or might in fact bestow. g. Saxagliptin was defective in design in that the products neither bore, nor were packaged with, nor were accompanied by, warnings adequate to alert users, including Plaintiff, of the increased risks associated with using the products, including, but not limited to, the risk of heart failure, congestive heart failure, cardiac failure, death from heart failure, and other serious health conditions Ii. Saxagliptin was not accompanied by adequate warnings and instructions for use that included adequate information to fully apprise users, consumers, and the medical, pharmaceutical and scientific communities of the potential risks and serious side effects associated with using the products. i. Saxagliptin was unsafe for normal or reasonably anticipated use. Said products were defective and unreasonably dangerous in design, construction and/or composition. j. Saxagliptin was defective and unreasonably dangerous because the products did not conform to an express warranty of the manufacturer about the product. k. Saxagliptin was defective and unreasonably dangerous due to inadequate warnings, inadequate clinical trials, testing and study, and inadequate reporting regarding the results of the clinical trials, testing and study. 57. Saxagliptin as manufactured and supplied by the Defendants was defective due to inadequate warnings and instructions because, after Defendants knew or should have known of the risk of injuries from use, Defendants failed to provide adequate warnings to the medical 11 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 15 of 42 Case 3:17-cv-02430-]CS Document 1 Filed 04/27/17 Page 12 of 25 community and the consumers to whom the drugs were directly marketed and advertised; and, further, Defendants continued to affirmatively promote Saxagliptin as safe and effective. 58. A reasonable person who had actual knowledge of the increased risks associated with using Saxagliptin would have concluded that Saxagliptin should not have been marketed to or used by Plaintiff and Plaintiffs physicians. 59. Despite the fact Defendants knew or should have known of the defective nature of Saxagliptin, Defendants continued to design, manufacture and sell Saxagliptin so as to maximize sales and profits at the expense of the public health and safety. Defendant thus acted with conscious and deliberate disregard of the foreseeable harm caused by Saxagliptin. 60. Plaintiff and the non-defendant health care providers involved could not, through the exercise of reasonable care, have discovered the risk of seriotis injury associated with and/or caused by Saxagliptin. 61. Plaintiff was not aware of the aforementioned defects at any time prior to the injuries caused by Saxagliptin. 62. Had adequate information regarding the safety of the products been provided to Plaintiff, Plaintiff would not have used Saxagliptin. 63. Defendants acted with conscious and/or deliberate disregard of the foreseeable harm caused by use of their products. 64. As a direct and proximate consequence of Defendants negligence, willful, wanton, and intentional acts, omissions, misrepresentations and otherwise culpable acts, Plaintiff suffered the injuries and damages alleged herein. 65. Defendants’ actions and omissions as identified in this Complaint show that Defendants acted maliciously and/or intentionally disregarded Plaintiffs rights so as to warrant the imposition of punitive damages. 12 COMPLAINT fOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 16 of 42 Case 3:17-cv-02430-]CS Document 1 Filed 04/27/17 Page 13 of 25 COUNT II NEGLIGENCE Plaintiff incorporates by reference each and every paragraph of this Complaint as though set forth in full in this cause of action and further alleges: 66. Defendants negligently manufactured, designed, labeled, packaged, distributed, marketed, advertised, and sold Saxagliptin. 67. At all relevant and material times, Defendants had a duty to Plaintiff to exercise reasonable care in the design, manufacture, advertising, marketing, labeling, packaging, distribution, post-market safety monitoring, reporting of adverse events, and sale of Saxagliptin, including a duty to ensure that the products did not cause users such as Plaintiff to suffer from unreasonable, dangerous side effects when used alone or in foreseeable combination with other drugs. 68. Defendants breached their duty of care to Plaintiff and were negligent in their actions, misrepresentations, and omissions in numerous ways including the following: a. Failing to perform adequate testing concerning the safety of Saxagliptin which would have shown Saxagliptin created a high risk of unreasonable, dangerous side effects, including causing and increasing the risk of heart failure, congestive heart failure, cardiac failure, death from heart failure, and other serious health conditions and other adverse effects, which would have permitted adequate and appropriate warnings to have been by given by Defendants to prescribing physicians and the consuming public, including Plaintiff; b. Failing to design Saxagliptin so as to properly minimize effects on receptors that were known to be associated with certain serious adverse effects; c. Failing to conduct adequate pre-clinical and clinical testing to determine the safety of Saxagliptin; 13 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 17 of 42 Case 3:17-cv-02430-]CS Document 1 RIed 04/27/17 Page 14 of 25 d. failing to report to the FDA, the medical community, and the general public the Saxagliptin data which indicated risks associated with using the product; e. Failing to conduct post-market monitoring and surveillance of Saxagliptin and analysis of adverse event reports; f. Designing, manufacturing, marketing, advertising, distributing, and selling Saxagliptin to consumers, including Plaintiff, without an adequate warning of risks associated with using the products and without proper and adequate instructions to avoid the harm which could foreseeably occur as a result of using the products; g. failing to exercise due care when advertising, promoting, and selling Saxagliptin; h. failing to use due care in the preparation, design and development of Saxagliptin to prevent, avoid, or minimize the risk of injury to individuals when the products were used; i. failing to completely, accurately and in a timely fashion, disclose the results of the pre-marketing testing and post-marketing surveillance and testing to Plaintiff, consumers, the medical community, and the FDA; j. failing to accompany Saxagliptin with proper warnings regarding all possible risks associated with using the products; k. Failing to use due care in the manufacture, inspection, and labeling of Saxagliptin to prevent risk of injuries to individuals who used the products; 1. Failing to provide adequate and accurate training and information to the sales representatives who sold the products; m. Failing to educate healthcare providers and the public about the safest use of the products; 14 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 18 of 42 Case 3:17-cv-02430-]CS Document 1 Filed 04/27/17 Page 15 of 25 n. Failing to give healthcare providers adequate information to weigh the risks of serious injury associated with the products; o. Failing to test and inspect Saxagliptin in a reasonable manner in order to ascertain whether or not it was safe and proper for the purpose for which it was designed, manufactured, and sold; p. Failing to warn Plaintiff of the danger of adverse medical conditions from the use of Saxagliptin; and q. Failing to label Saxagliptinto adequately warn Plaintiff of the serious adverse side effects with the use of Saxagliptin. 69. Defendants advertised, marketed, sold and distributed Saxagliptin despite the fact that Defendants knew or should have known of the increased risks associated with using the products, including but not lii-nited to heart failure, congestive heart failure, cardiac failure, death from heart failure, and other serious health conditions and other adverse effects of which Plaintiff and Plaintiffs healthcare providers would not have been aware. 70. Defendants, individually and collectively, had a duty to warn the FDA, their customers, the medical community and the public about the increased risk of injury but failed to do so. 71. Defendants are guilty of negligence per se in that the Defendants violated the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §30 1, et seq., and the Sherman Food, Drug and Cosmetic Law, as well as other applicable laws, statutes, and regulations. a. The Defendants’ acts and omissions, including but not limited to Defendants’ off-label marketing, constitute an adulteration and/or misbranding as defined by the Federal food, Drug and Cosmetic Act, 21 U.S.C. §30 1, et seq. Persons such as Plaintiff were the parties intended to be protected by such legislation and whose injuries said regulations were designed to prevent. Defendants’ conduct was a proximate cause of Plaintiffs injuries. 15 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 19 of 42 Case 3:17-cv-02430-JCS Document 1 Filed 04/27/17 Page 16 of 25 b. The Defendants’ also failed to report adverse events as required by the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §30 1, et seq. Persons such as Plaintiff were the parties intended to be protected by such legislation and whose injuries said regulations were designed to prevent. Defendants’ conduct was a proximate cause of Plaintiffs injuries. 72. Despite the fact Defendants knew or should have known that Saxagliptin increased the risk of serious injury including but not limited to heart failure, congestive heart failure, cardiac failure, death from heart failure, and other serious health conditions, Defendants continued to manufacture, market, advertise, sell and distribute Saxagliptinto consumers, including Plaintiff. 73. Defendants negligently and recklessly represented to Plaintiff, physicians, and other persons and professionals Defendants knew would justifiably rely on the representations, that Saxagliptin was safe to use and that the utility of the products outweighed any risk in use for their intended purposes. 74. Defendants negligently and recklessly failed to disclose to Plaintiff and others important safety and efficacy information about Saxagliptin, thereby suppressing material facts while under a duty to disclose such information. 75. Defendants’ representations about the safety and adverse side effects of Saxagliptin were negligently and recklessly made in that Saxagliptin in fact caused injtlry, was unsafe, and the benefits of its use were far outweighed by the risk associated with use thereof. 76. Defendants knew or should have known that their representations and omissions were false. Defendants made such false, negligent and reckless representations and omissions with the intent or purpose that Plaintiff and any non-defendant physicians would rely upon such representations, leading to the use of Saxagliptin as described. 77. Defendants omitted, suppressed and/or concealed material facts concerning the dangers and risk of injuries associated with the use of Saxagliptin, including serious injury. Furthermore. Defendants purpose was willfully blind to. ignored, downplayed, avoided, and/or otherwise understated the serious nature of the risks associated with the tise of Saxagliptin. 16 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 20 of 42 Case 3:17-cv-02430-]CS Document 1 IZiled 04/27/17 Page 17 of 25 78. At the time Defendants made these misrepresentations and/or omissions, they knew or should have known that Saxagliptin was unreasonably dangerous and not what Defendants had represented to Plaintiff, as well as the medical community, the FDA and the consuming public. 79. Defendants’ misrepresentations and/or omissions were undertaken with an intent that doctors and patients, including Plaintiff, rely upon them. $0. Plaintiff and Plaintiffs healthcare providers did not know that these representations were false and justifiably relied on and were induced by Defendants’ misrepresentations, omissions, and/or active concealment of the dangers of Saxagliptinto employ these products. $1. As a direct and proximate consequence of Defendants’ negligent, willful, wanton, and intentional acts, omissions, misrepresentations and otherwise culpable acts, Plaintiff sustained injuries and damages. $2. Had Plaintiff been aware of the increased risk of side effects associated with Saxagliptin and the relative efficacy of Saxagliptin compared with other readily available products, Plaintiff would not have used these products. $3. Defendants’ actions and omissions as identified in this Complaint show that Defendants acted maliciously and/or intentionally disregarded Plaintiffs rights so as to warrant the imposition of punitive damages. COUNT III FAILURE TO WARN Plaintiff incorporates by reference each and every paragraph of this Complaint as though set forth in full in this cause of action, and further alleges: $4. Saxagliptin was unreasonably dangerous, even when used in a foreseeable manner as designed and intended by Defendants. 85. At all relevant and material times, the Defendants designed, manufactured, packaged, marketed, advertised, distributed, and sold Saxagliptin, placing the products into the stream of commerce for sale to, and use by, members of the public, including the Saxagliptin used by Plaintiff. 17 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 21 of 42 Case 3:17-cv-02430-JCS Document 1 IZiled 04/27/17 Page 18 of 25 86. At all relevant and material times, Saxagliptin was designed, manufactured, packaged, marketed, advertised, distributed, and sold by Defendants in a defective and unreasonably dangerous condition. 87. The Saxagliptin manufactured by Defendants reached Plaintiff without substantial change and was ingested as directed. The Saxagliptin was defective and unreasonably dangerous when it entered into the stream of commerce and when used by Plaintiff. 88. The Plaintiff was administered the Saxagliptin for its intended purpose. 89. Plaintiff used Saxagliptin in the foreseeable manner normally intended, recommended, promoted, and marketed by Defendants. 90. Defendants failed to warn and/or adequately warn Plaintiff, consumers, physicians, and healthcare professionals of the increased health risks associated with using Saxagliptin. 91. Plaintiff did not have the same knowledge as Defendants and no adequate warning was communicated to them. 92. The Plaintiff could not have discovered any defect in the Saxagliptin through the exercise of reasonable care. 93. Defendants, as manufacturers of Saxagliptin, are held to the level of knowledge of an expert in the field, and further, Defendants knew or should have known that warnings and other clinically relevant information and data which they distributed regarding the risks of injuries and death associated with the use of Saxagliptin was incomplete and inadequate. 94. Plaintiff did not have the same knowledge as Defendants and no adequate warning or other clinically relevant information and data was communicated to Plaintiff or to Plaintiffs treating physicians. The warnings given by Defendants were inaccurate, unclear, ambiguous, and/or incomplete. 95. Defendants had a continuing duty to provide consumers, including Plaintiff, and Plaintiffs physicians with warnings and other clinically relevant information and data regarding the risks and dangers associated with Saxagliptin, as it became or could have become available to Defendants. 18 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 22 of 42 Case 3:17-cv-02430-]CS Document 1 liled 04/27/17 Page 19 of 25 96. Defendants marketed, promoted, distributed and sold unreasonably dangerous and defective prescription Saxagliptin to health care providers empowered to prescribe and dispense to consumers, including Plaintiff, without adequate warnings and other clinically relevant information and data. Through both omissions and affirmative misstatements, Defendants misled the medical community about the risk/benefit balance of Saxagliptin, which resulted in injury to Plaintiff. 97. Defendants knew or should have known that Saxagliptin caused unreasonable and dangerous side effects and they continued to promote and market Saxagliptin without stating safer and more or equally effective alternative drug products existed and/or providing adequate clinically relevant information and data. 9$. Defendants knew or should have known that consumers, including Plaintiff, would foreseeably and needlessly suffer injury or death as a result of Defendants’ conduct. 99. Defendants failed to provide timely and adequate warnings to physicians, pharmacies, and consumers, including Plaintiff and to Plaintiffs intermediary physicians, in at least the following ways: a. Defendants failed to include adequate warnings and/or provide adequate clinically relevant information and data that would alert Plaintiffs physicians to the dangerous risks of Saxagliptin including, among other things, their tendency to increase the risk of, and/or cause, heart failure, congestive heart failure, cardiac failure, and death related to those events; b. Defendants failed to inform Plaintiff and Plaintiffs physicians that Saxigliptin had not been adequately tested to determine the full extent of the safety risks associated with use of the product; c. Defendants failed to provide adequate post-marketing warnings and instructions after Defendants knew or should have known of the significant risks of heart failure, congestive heart failcire, cardiac failure, and death related to those events associated with use of Saxagliptin; aiid 19 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 23 of 42 Case 3:17-cv-02430-]CS Document 1 RIed 04/27/17 Page 20 of 25 d. Defendants continued to aggressively promote and sell Saxagliptin even after they knew or should have known of the unreasonable risks of developing heart failure, cardiac failure, and death related to those events from ingestion of Saxagliptin. 100. Defendants and each of them had a duty to warn the FDA, the medical community, Plaintiff, and Plaintiffs physicians about the increased risks of injury but failed to do so. 101. Defendants had a duty and obligation to provide Plaintiff and Plaintiffs physicians with adequate clinically relevant information and data and warnings regarding the adverse health risks associated with exposure to Saxagliptin, and/or that there existed safer and more or equally effective alternative drug products, but failed to do so. 102. By failing to provide Plaintiff and Plaintiffs physicians with adequate clinically relevant information and data and warnings regarding the adverse health risks associated with exposure to Saxagliptin, and/or that there existed safer and more or equally effective alternative drug products, Defendants breached their duty of reasonable care and safety. 103. Defendants’ actions described above were performed willfully, intentionally, and with reckless disregard of the life and safety of the Plaintiff and the public. 104. As a direct and proximate result of the actions and inactions of Defendants as set forth above, Plaintiff sustained injuries and damages. 105. Defendants’ actions and omissions as identified in this Complaint show that Defendants acted maliciously and/or intentionally disregarded Plaintiffs rights so as to warrant the imposition of punitive damages. COUNT IV BREACH OF WARRANTY OF MERCHANTABILITY Plaintiff incorporates by reference each and every paragraph of this Complaint as though set forth in full in this cause of action and further alleges: 106. At all times mentioned in this Complaint, Defendants manufactured, compounded, packaged. distributed, recommended, merchandised, advertised, promoted, supplied and sold Saxagliptin, and prior to the time it was prescribed to Plaintiff, Defendants 20 COMPLMNT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 24 of 42 Case 3:17-cv-02430-]CS Document 1 Piled 04/27/17 Page 21 of 25 impliedly warranted to Plaintiff, and Plaintiff’s physicians and hcalthcare providers, that Saxagliptin was of merchantable quality and safe for the use for which it was intended. 107. Defendants knew and intended that Saxagliptin be used by Plaintiff and other consumers when the products were placed into the stream of commerce. 108. Defendants knew of the use for which Saxagliptin was intended and impliedly warranted Saxagliptin to be of merchantable quality and safe and fit for their intended use. 109. Plaintiff and their healthcare providers reasonably relied upon the expertise, skill, judgment and knowledge of Defendants, and upon the express and/or implied warranty that Saxagliptin was safe, of merchantable quality, and fit for use by Plaintiff and other consumers. 110. The Saxagliptin used by Plaintiff was not safe, of merchantable quality, or fit for its intended use. 111. The product was unsafe for its intended use and was not of merchantable quality, as warranted by Defendants, in that Saxagliptin had very dangerous propensities when put to its intended use and would cause severe injury (or death) to the user. Saxagliptin was unaccompanied by adequate warnings of their dangerous propensities that were either known or reasonably scientifically knowable at the time of distribution. 112. The Saxagliptin used by Plaintiff was neither safe nor fit for use because Saxagliptin products were and are unreasonably dangerous and unfit for the ordinary purposes for which they are used. 113. As a direct and proximate result of the breach of warranty of merchantability by Defendants, Plaintiff sustained injuries and damages. 114. Defendants’ actions and omissions as identified in this Complaint show that Defendants acted maliciously and/or intentionally disregarded Plaintiffs rights so as to warrant the imposition of punitive damages. COUNT V BREACH OF EXPRESS WARRANTY Plaintiff incorporates by reference each and every paragraph of this Complaint as though set forth in full in this cause of action and further alleges: 21 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 25 of 42 Case 3:17-cv-02430-]CS Document 1 Filed 04/27/17 Page 22 of 25 115. The aforementioned manufacturing, compounding, packaging, designing, distributing, testing, constructing, fabricating, analyzing, recommending, merchandizing, advertising, promoting, supplying and selling of Saxagliptin was expressly warranted to be safe for use by Plaintiff and other members of the general public. 116. Defendants expressly represented to Plaintiff, consumers and the medical community that Saxagliptin was: a. safe; b. efficacious; c. fit for use in persons with Type 2 diabetes mellitus; d. of merchantable quality; e. adequately tested; f. well tolerated in adequate and well-controlled clinical studies; and g. did not increase the risk of experiencing serious, life threatening side effects. 117. Defendants breached those express warranties as follows: a. Defendants misrepresented the safety of Saxagliptin in its labeling, advertising, marketing materials, seminar presentations, publications, notice letters, and regulatory submissions; b. Defendants misrepresented the risks associated with using Saxagliptin; c. Defendants withheld and/or concealed and/or downplayed the information and/or evidence that the products were associated with an increased risk of serious injury; d. Defendants misrepresented that Saxagliptin was as safe or safer than other available forms of treatment for Plaintiffs conditions; and e. Saxagliptin was unaccompanied by adequate warnings of its dangerous propensities that were either known or knowable at the time of distribution. 22 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 26 of 42 Case 3:17-cv-02430-]CS Document 1 IZiled 04/27/17 Page 23 of 25 11 8. Saxagliptin did not conform to Defendants’ express representations and warranties. 119. At all relevant times, Saxagliptin did not perform as safely as an ordinary consumer would expect when used as intended or in a reasonably foreseeable manner. 120. At alt relevant times, Saxagliptin did not perform in accordance with the Defendants’ representations because Saxagliptin is not safe and causes high levels of serious side effects. 121. In deciding to purchase and use Saxagliptin, Plaintiff, other consumers, and the medical community relied upon Defendants’ express warranties. 122. As a direct and proximate consequence of Defendants’ negligence, willful, wanton, and intentional acts, omissions, misrepresentations and otherwise culpable acts, Plaintiff sustained injuries and damages. 123. Defendants’ actions and omissions as identified in this Complaint show that Defendants acted maliciously and/or intentionally disregarded Plaintiffs rights so as to warrant the imposition of punitive damages. COUNT VI BREACH OF IMPLIED WARRANTY Plaintiff incorporates by reference each and every paragraph of this Complaint as though set forth in full in this cause of action and further alleges: 124. At all relevant and material times, Defendants manufactured, distributed, advertised, and sold Saxagliptin. 125. Defendants impliedly warranted to Plaintiff that Saxagliptin was safe for use by Plaintiffs and the consuming population. 126. Defendants knew and intended that Saxagliptin be tised in treatment for persons with Type 2 diabetes mellitus when the products were placed into the stream of commerce. 127. Plaintiff and Plaintiffs healthcare providers used Saxagliptinas intended and directed by the Defendants, and in a foreseeable manner as intended, recommended, promoted, and marketed by Defendants. 23 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 27 of 42 Case 3:17-cv-02430-]CS Document 1 Filed 04/27/17 Page 24 of 25 12$. Plaintiff was a foreseeable user of Defendantst product, Saxagliptin. Saxagliptin was expected to reach, and did in fact reach, Plaintiff without substantial change in the condition in which the products were manufactured and sold by Defendatits. 129. Plaintiff and Plaintiffs healthcare providers reasonably relied upon the expertise, skill, judgment and knowledge of Defendants, and upon the Defendants’ implied warranty that Saxagliptin was safe, of merchantable quality, and fit for use. 130. The Saxagliptin used by Plaintiff was not safe, of merchantable quality, nor fit for use. 131. The Saxagliptin used by Plaintiff did not perform in accordance with Defendants’ representations because Saxagliptin is not safe and causes high levels of serious, life-threatening side effects. 132. Defendants breached the implied warranty in that Saxagliptin did not conform to Defendants’ representations. 133. As a direct and proximate consequence of Defendants’ negligence, willful, wanton, and intentional acts, omissions, misrepresentations and otherwise culpable acts described herein, Plaintiff sustained inj uries and damages. 134. Defendants’ actions and omissions as identified in this Complaint show that Defendants acted maliciously and/or intentionally disregarded Plaintiffs rights so as to warrant the imposition of punitive damages. PRAYER FOR RELIEF Plaintiff incorporates by reference each and every paragraph of this Complaint as though set forth here in full and further prays: 135. So far as the law and this Court allows, Plaintiff demands judgment against each Defendant on each count as follows: a. All available compensatory damages for the described losses with respect to each cause of action; b. Past and future medical expenses, as well as the cost associated with past and future life care; 24 COMPLAINT FOR DAMAGES Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 28 of 42 Case 3:17-cv-02430-]CS Document 1 Filed 04/27117 Page 25 of 25 c. Past and future lost wages and loss of earning capacity; d. Past and future emotional distress: e. Consequential damages: f. All available noneconomic damages, including without limitation pain, suffering, and loss of enjoyment o life; g. All damages wrongful death damages permitted by law, where applicable; h. Disgorgement of prolits obtained through unjust enrichment: i. Restitution: Punitive damages ‘th respect to each cause of action: k. Reasonable attorneys fees where recoverable; I, Costs of this action: 111. Prejudgrnent and all other interest recoverable; and n. Such other additional and further relief as Plaintiff may he entitled to in law or in equity. i)EMANI) FOR JURY TRIAL Plaintiff demands a trial by jury on all issues so Dated: April 27, 2017 By: A. Welling (CA Bar No. 291i3) SANDERS PH I LLIPS C R()SSMA, LLC 2860 Michelle Drive, Suite 220 J Irvine, CA 90606 Tel: (877) 480-9142 Fax: (213) 330-0346 LWilin andis1 rnclrn CQMiLAfNT FOT? s)AMAGFS Case 3:17-cv-02430-JST Document 16-1 Filed 05/26/17 Page 29 of 42 EXHIBIT B Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 30 of 422430 6 5 6 59650481 Oct 04 2016 05:33PM Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 31 of 422430 6 5 6 Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 32 of 422430 6 5 6 Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 33 of 422430 6 5 6 Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 34 of 422430 6 5 6 Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 35 of 422430 6 5 6 Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 36 of 422430 6 5 6 Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 37 of 422430 6 5 6 EXHIBIT C Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 38 of 422430 6 5 6 60137631 Jan 30 2017 04:10PM Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 39 of 422430 6 5 6 Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 40 of 422430 6 5 6 Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 41 of 422430 6 5 6 Case 3:17-cv-00247-JST Document 13-1 Filed 04/24/17 Page 42 of 422430 6 5 6 [PROPOSED] ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION (FRCP 12(B)(2)) OR, IN THE ALTERNATIVE, TO TRANSFER (28 U.S.C. § 1404(A)) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA ANITA ROCHELLE HOLLAND, Plaintiff, v. BRISTOL-MYERS SQUIBB COMPANY; ASTRAZENECA PHARMACEUTICALS LP; and McKESSON CORPORATION, Defendants. Case No.: 3:17-cv-02430-JST [PROPOSED] ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION (FRCP 12(B)(2)) OR, IN THE ALTERNATIVE, TO TRANSFER (28 U.S.C. § 1404(A)) Judge: Honorable Jon S. Tigar Case 3:17-cv-02430-JST Document 16-2 Filed 05/26/17 Page 1 of 5 2 [PROPOSED] ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION (FRCP 12(B)(2)) OR, IN THE ALTERNATIVE, TO TRANSFER (28 U.S.C. § 1404(A)) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 There are two types of jurisdiction: general and specific. See Daimler AG v. Bauman 571 U.S. ___, 134 S. Ct. 746, 754-755 (2014). This Court lacks general jurisdiction over Bristol- Myers Squibb Company (BMS) and AstraZeneca Pharmaceuticals LP (AstraZeneca) because neither BMS nor AstraZeneca are “at home” in California. Id. at 749. BMS is a Delaware corporation with its principal place of business in New York, New York. See Exhibit A to the Declaration of William E. Steimle (Steimle Decl.), ¶ 9; Notice of Motion and Motion to Dismiss for Lack of Personal Jurisdiction (FRCP 12(b)(2)) or, in the alternative, to Transfer (28 U.S.C. § 1404(a), p. 5, n 1. AstraZeneca is a Delaware limited partnership with its principal place of business in Wilmington, Delaware. See Steimle Decl., Ex. A, ¶ 10. This Court lacks specific jurisdiction over BMS and AstraZeneca because plaintiff’s claims do not arise from any of their activities within California. The Ninth Circuit interprets the “arising from” requirement for specific jurisdiction to impose a causal connection between a defendant’s forum-state contacts and a plaintiff’s claims. See Menken v. Emm, 503 F.3d 1050, 1058 (9th Cir. 2007).Under this standard, a defendant’s forum-state contacts must be the “but for” cause of a plaintiff’s injuries. Ibid. At all relevant times, plaintiff was a resident of North Carolina. See Steimle Decl., Ex. A, ¶ 7. She does not allege that she was prescribed the drugs at issue (Onglyza and Kombiglyze) in California, that she ingested either drug in California, or that she suffered any injury in California. She identifies no causal connection between her claims and the contacts AstraZeneca and BMS have with California. Thus, her claims would have been exactly the same even if AstraZeneca and BMS had no contacts with California. Accordingly, these forum contacts cannot be the cause of plaintiff’s claimed injury and this Court does not have specific jurisdiction over plaintiff’s claims. Having considered Defendants Bristol-Myers Squibb Company’s, AstraZeneca Pharmaceutical LP’s, and McKesson Corporation’s motion to dismiss for lack of personal jurisdiction (FRCP 12(b)(2) (Motion to Dismiss), the Motion to Dismiss is GRANTED. Therefore, Defendants Bristol-Myers Squibb Company’s, AstraZeneca Pharmaceutical LP’s, and McKesson Corporation’s motion to transfer this case to the Middle District of North Case 3:17-cv-02430-JST Document 16-2 Filed 05/26/17 Page 2 of 5 3 [PROPOSED] ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION (FRCP 12(B)(2)) OR, IN THE ALTERNATIVE, TO TRANSFER (28 U.S.C. § 1404(A)) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Carolina pursuant to 28 U.S.C. § 1404(a) is DENIED AS MOOT. IT IS SO ORDERED. Dated: _______________ ____________________________________ Honorable Jon S. Tigar United States District Judge Case 3:17-cv-02430-JST Document 16-2 Filed 05/26/17 Page 3 of 5 4 [PROPOSED] ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION (FRCP 12(B)(2)) OR, IN THE ALTERNATIVE, TO TRANSFER (28 U.S.C. § 1404(A)) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 [In the alternative:] The interests of justice and judicial efficiency strongly favor transferring this case to the Middle District of North Carolina so that it might be litigated in the judicial district where plaintiff resides. The transfer of a case from one district court to another is appropriate “for the convenience of parties and witnesses, in the interest of justice.” 28 U.S.C. § 1404(a). Plaintiff has no connection to the Northern District of California. She alleges she sought treatment, was prescribed Onglyza, ingested Onglyza, and was injured in North Carolina. Thus, the documents, records, and witnesses (including plaintiff’s prescribing and treating doctors) relevant to plaintiff’s claims are located in North Carolina. As the events giving rise to plaintiff’s claims occurred in North Carolina, each cause of action will be governed by North Carolina law. Such transfer would conserve judicial resources and avoid inconsistent rulings by ensuring that plaintiff’s case is litigated in a court familiar with governing law, near the relevant documents, and with subpoena power over the critical non-party witnesses. Given the early stage of this case, trial will in no way be hindered or delayed if the case is transferred at this time to the appropriate district court. Rather, transfer at this point will result in significant discovery and case management benefits through reduced costs and easier access to evidence. Having considered Defendants Bristol-Myers Squibb Company’s, AstraZeneca Pharmaceutical LP’s, and McKesson Corporation’s motion to transfer this case to the Middle District of North Carolina pursuant to 28 U.S.C. § 1404(a) (Motion to Transfer), the Motion to Transfer is GRANTED. IT IS SO ORDERED. Dated: _______________ ____________________________________ Honorable Jon S. Tigar United States District Judge Case 3:17-cv-02430-JST Document 16-2 Filed 05/26/17 Page 4 of 5 5 [PROPOSED] ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION (FRCP 12(B)(2)) OR, IN THE ALTERNATIVE, TO TRANSFER (28 U.S.C. § 1404(A)) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 CERTIFICATE OF SERVICE The undersigned counsel for Defendants BRISTOL-MYERS SQUIBB COMPANY, ASTRAZENECA PHARMACEUTICALS LP, and MCKESSON CORPORATION hereby certifies that a true and correct copy of the foregoing document was filed with the Court and served electronically through the CM-ECF (electronic case filing) system to all counsel of record to those registered to receive a Notice of Electronic Filing for this case on May 26, 2017. /s/ William E. Steimle WILLIAM E. STEIMLE Attorney for Defendant BRISTOL-MYERS SQUIBB COMPANY, ASTRAZENECA PHARMACEUTICALS LP, and MCKESSON CORPORATION Case 3:17-cv-02430-JST Document 16-2 Filed 05/26/17 Page 5 of 5