Thomas v. Takeda Pharmaceuticals USA, Inc. et alMOTION to DISMISS for LACK of JURISDICTIONE.D. Cal.March 31, 201715194349-v1 NTC OF MOTION TO DISMISS FOR INSUFFICIENT SERVICE, ETC. Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 VENABLE LLP Celeste M. Brecht (SBN 238604) Email: cmbrecht@venable.com 2049 Century Park East, Suite 2300 Los Angeles, CA 90067 Telephone: (310) 229-9900 Facsimile: (310) 229-9901 Attorneys for Defendants Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals International, Inc., Takeda Development Center Americas, Inc., Takeda Pharmaceuticals America, Inc., and Takeda Pharmaceutical Company Limited IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF CALIFORNIA SHARRON THOMAS, Plaintiff, v. TAKEDA PHARMACEUTICALS USA, INC., TAKEDA PHARMACEUTICALS AMERICA, INC.; TAKEDA PHARMACEUTICALS INTERNATIONAL INC.; TAKEDA DEVELOPMENT CENTER AMERICAS, INC.; TAKEDA GMBH; TAKEDA PHARMACEUTICAL COMPANY LIMITED; TAKEDA PHARMACEUTICAL COMPANY LIMITED, Defendants. CASE NO. 1:16-CV-01566-LJO-EPGx Hon. Lawrence J. O’Neill Courtroom 4 NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULES OF CIVIL PROCEDURE 4(F) AND 12(B)(5) [Concurrently filed with Memorandum of Points and Authorities; Declaration of Celeste M. Brecht; and [Proposed] Order] DATE: May 4, 2017 TIME: 8:30 a.m. CTRM: 4 Action Filed: October 14, 2016 Trial Date: None Set Case 1:16-cv-01566-LJO-EPG Document 12 Filed 03/31/17 Page 1 of 4 1 15194349-v1 NTC OF MOTION TO DISMISS FOR INSUFFICIENT SERVICE, ETC. Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on May 4, 2017, at 8:30 p.m., or as soon thereafter as this matter may be heard by the Honorable Lawrence J. O’Neill, in the above-referenced Court, located at 2500 Tulare Street, Fresno, California 92721, Defendant Takeda Pharmaceutical Company Limited (“Takeda”) will, and hereby does, move this Court for an order dismissing the Complaint of Sharron Thomas in its entirety for insufficient service of process pursuant to Federal Rules of Civil Procedure. Defendant Takeda, by and through its undersigned counsel, respectfully submits this Motion to Dismiss Plaintiff Sharron Thomas’s Complaint in the above captioned matter pursuant to Federal Rules of Civil Procedure 4(f) and 12(b)(5).1 Plaintiff’s attempt to serve process by mail via Federal Express on Takeda Pharmaceutical Company Limited (“TPC”), a company located in Japan, was ineffective according to the requirements of Federal Rule of Civil Procedure 4(f) for service in a foreign country. Plaintiff did not attempt to serve process through the Hague Convention. In the absence of such service and where an international agreement allows but does not specify other means of service, Rule 4(f) requires that service of process by international mail “be sent by the clerk of the court, using a form of mail requiring signed receipt” or through a procedure “specifically directed by the district court.” Brockmeyer v. May, 383 F. 3d 798, 809 (9th Cir. 2004). This motion is based on the authority of Federal Rules of Civil Procedure 4(f) and 12(b)(5), Brockmeyer v. May, 383 F. 3d 798, 809 (9th Cir. 2004), as well as this notice, the attached memorandum of points and authorities, the Declaration 1 Counsel for Plaintiff and Defendants agreed that the deadline for Takeda Pharmaceutical Company Limited to respond to the Complaint would be March 31, 2017. (Declaration of Celeste Brecht, ¶ 2.) Case 1:16-cv-01566-LJO-EPG Document 12 Filed 03/31/17 Page 2 of 4 2 15194349-v1 NTC OF MOTION TO DISMISS FOR INSUFFICIENT SERVICE, ETC. Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 of Celeste M. Brecht, any opposition, any reply, and oral argument that may be presented at the hearing on this matter. Dated: March 31, 2017 VENABLE LLP By: /s/ Celeste M. Brecht Celeste M. Brecht Attorneys for Defendants Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals International, Inc., Takeda Development Center Americas, Inc., Takeda Pharmaceuticals America, Inc., and Takeda Pharmaceutical Company Limited Case 1:16-cv-01566-LJO-EPG Document 12 Filed 03/31/17 Page 3 of 4 15194349-v1 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 PROOF OF SERVICE STATE OF CALIFORNIA ) ) ss. COUNTY OF LOS ANGELES ) I am employed in the County of Los Angeles, State of California. I am over the age of 18 and not a party to the within action; my business address is Venable LLP, 2049 Century Park East, Suite 2300, Los Angeles, California. On March 31, 2017, I served a copy / original of the foregoing document(s) described as NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULES OF CIVIL PROCEDURE 4(F) AND 12(B)(5) on the interested parties in this action addressed as follows Melinda Davis Nokes, Esq. Weitz & Luxenberg 1880 Century Park East Suite 700 Los Angeles, CA 90067 Tel: (310) 247-0921 Fax: (310) 786-9927 Email: mnokes@weitzlux.com Attorneys for Plaintiff By placing true copies thereof enclosed in a sealed envelope(s) addressed as stated above. BY ELECTRONIC MEANS (FRCP 5(b)(2)(E)): Pursuant to FRCP 5(b)(2)(E), I served the above stated document by electronic means to the interested parties in this action whose names and e-mail addresses are listed above. I did not receive, within a reasonable time after the transmission, any electronic message or other indication that the transmission was unsuccessful. Service by e-mail or electronic means was agreed upon based on an agreement of the parties to accept service. I declare that I am employed in the office of a member of the Bar of this Court at whose direction the service was made. I declare under penalty of perjury under the laws of the United States of America that the above is true and correct. Executed on March 31, 2017, at Los Angeles, California. /s/ Celeste M. Brecht [Print Name] Case 1:16-cv-01566-LJO-EPG Document 12 Filed 03/31/17 Page 4 of 4 15194304-v1 MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 VENABLE LLP Celeste M. Brecht (SBN 238604) Email: cmbrecht@venable.com 2049 Century Park East, Suite 2300 Los Angeles, CA 90067 Telephone: (310) 229-9900 Facsimile: (310) 229-9901 Attorneys for Defendants Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals International, Inc., Takeda Development Center Americas, Inc., Takeda Pharmaceuticals America, Inc. and Takeda Pharmaceutical Company Limited IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF CALIFORNIA SHARRON THOMAS, Plaintiff, v. TAKEDA PHARMACEUTICALS USA, INC., TAKEDA PHARMACEUTICALS AMERICA, INC.; TAKEDA PHARMACEUTICALS INTERNATIONAL INC.; TAKEDA DEVELOPMENT CENTER AMERICAS, INC.; TAKEDA GMBH; TAKEDA PHARMACEUTICAL COMPANY LIMITED; TAKEDA PHARMACEUTICAL COMPANY LIMITED, Defendants. CASE NO. 1:16-CV-01566-LJO-EPGx Hon. Lawrence J. O’Neill Courtroom 4 MEMORANDUM IN SUPPORT OF TAKEDA PHARMACEUTICAL COMPANY LIMITED’S MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) [Concurrently filed with Notice of Motion; Declaration of Celeste M. Brecht; and [Proposed] Order] DATE: May 4, 2017 TIME: 8:30 a.m. CTRM: 4 Action Filed: October 14, 2016 Trial Date: None Set Case 1:16-cv-01566-LJO-EPG Document 12-1 Filed 03/31/17 Page 1 of 9 1 15194304-v1 MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 Defendant Takeda Pharmaceutical Company Limited, by and through its undersigned counsel, respectfully submits this Motion to Dismiss Plaintiff Sharron Thomas’s Complaint in the above captioned matter for insufficient service of process pursuant to Federal Rules of Civil Procedure 4(f) and 12(b)(5).1 I. INTRODUCTION Plaintiff’s attempt to serve process by mail via Federal Express on Takeda Pharmaceutical Company Limited (“TPC”), a company located in Japan, was ineffective according to the requirements of Federal Rule of Civil Procedure 4(f) for service in a foreign country. Plaintiff did not attempt to serve process through the Hague Convention. In the absence of such service and where an international agreement allows but does not specify other means of service, Rule 4(f) requires that service of process by international mail “be sent by the clerk of the court, using a form of mail requiring signed receipt” or through a procedure “specifically directed by the district court.” Brockmeyer v. May, 383 F. 3d 798, 809 (9th Cir. 2004). Accordingly, Plaintiff’s mailing of the Summons and a copy of the Complaint via Federal Express directly to TPC is insufficient and defective. Even assuming that this method of service was permitted under Rule 4, Plaintiff’s mailing of the Summons and a copy of the Complaint is deficient because, as has been recognized in at least one case in this Circuit, Japanese law does not permit service of process through Federal Express delivery. TPC respectfully requests that the Court dismiss Plaintiff’s Complaint against TPC for insufficient service of process pursuant to Federal Rules of Civil Procedure 4(f) and 12(b)(5). / / / / / / 1 Counsel for Plaintiff and Defendants agreed that the deadline for Takeda Pharmaceutical Company Limited to respond to the Complaint would be March 31, 2017. (Declaration of Celeste M. Brecht (“Brecht Decl.”) ¶ 2.) Case 1:16-cv-01566-LJO-EPG Document 12-1 Filed 03/31/17 Page 2 of 9 2 15194304-v1 MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 II. STATEMENT OF FACTS Plaintiff Sharon Thomas mailed the Summons and a copy of her Complaint through Federal Express to Takeda Pharmaceutical Company Limited in Japan on or around December 9, 2016 (See Ex. A, Letter with Summons and Complaint (“Letter”) attached to the Brecht Declaration). Plaintiff mailed the Letter to TPC at 1-1 Doshomachi 4-chrome, Chuo-Ku, Osaka, 540-8645, Japan to the attention of the “Legal Department,” with a copy to Stacey Dixon Calahan, Assistant General Counsel, Litigation for a different Takeda company, Takeda Pharmaceuticals U.S.A., Inc., which is located in the United States. Id. Plaintiff did not serve them through the Clerk of this Court or any other formal means through the Japanese government. III. ARGUMENT A. Standard Of Review “Before a federal court may exercise personal jurisdiction over a defendant, the procedural requirements of service of summons must be satisfied.” In re Focus Media Inc., 387 F.3d 1077, 1081 (9th Cir. 2004). Accordingly, “[a] defendant may move to dismiss based on insufficient process under Federal Rule of Civil Procedure 12(b)(4) or insufficient service of process pursuant to Federal Rule of Civil Procedure 12(b)(5).” Oliver & Tate Enterprises, Inc. v. Foundations Worldwide, Inc., 2013 WL 4446827 at *3 (C.D. Cal. June 18, 2013); see also Corona v. Verderosa, 2014 WL 7336230 at *3 (E.D. Cal. Dec. 22, 204) (“Under the Federal Rule of Civil Procedure 12(b)(5), a defendant may challenge any departure from the proper procedure for serving the summons and complaint as ‘insufficient service of process.’”). “Without substantial compliance with Rule 4 neither actual notice nor simply naming the defendant in the complaint will provide personal jurisdiction.” Oliver & Tate Enterprises, Inc., 2013 WL 4446827 at *3 (citing Direct Mail Specialists, Inc. v. Eclat Computerized Techs., Inc., 840 F.2d 685, 687 (9th Cir. 1988)). “Once a defendant challenges service of process, Case 1:16-cv-01566-LJO-EPG Document 12-1 Filed 03/31/17 Page 3 of 9 3 15194304-v1 MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 the plaintiff has the burden of establishing the validity of service of process under Rule 4.” Corona, 2014 WL 7336230 at *3. B. Requirements for Foreign Service Plaintiff’s service of the Complaint and Summons was defective because she failed to serve it in a manner recognized and accepted under the Federal Rules of Civil Procedure. Service of process attempted abroad is generally governed by the Hague Convention. Brockmeyer v. May, 383 F.3d 798, 801 (9th Cir. 2004). The Convention permits member countries, including Japan, to designate a central authority to accept process and effect service on the individual to be served. Id. “The convention also provides that it does not ‘interfere with’ other methods of serving documents,” including, as long as the country of designation does not object, transmittal of judicial documents “by postal channels, directly to persons abroad.” Id. (citing Article 10(a) of the Convention). Plaintiff did not serve TPC through Japan’s central authority for service of process under the Hague Convention. Instead, Plaintiff attempted to serve TPC directly through a postal channel, i.e., Federal Express. Although Article 10 of the Convention will not “interfere” with transmittal of judicial documents via mail, and Japan has not objected to the article permitting transmittal of documents via mail, Plaintiff still was required to comply with the Federal Rules on service abroad and yet failed to do so. Since TPC is located in Japan, Plaintiff had to comply with the requirements set forth under Rule 4(f) for service on an individual in a foreign country. She did not. Plaintiff did not serve the Summons and Complaint through the clerk of the Court or through other means directed by this Court. Furthermore, Japan does not permit service of process via Federal Express. Based on these deficiencies, Plaintiff’s Complaint as to Defendant TPC should be dismissed. Case 1:16-cv-01566-LJO-EPG Document 12-1 Filed 03/31/17 Page 4 of 9 4 15194304-v1 MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 C. Plaintiff Did Not Serve Her Complaint On TPC Through A Recognized And Accepted Method Under Rule 4 Rule 4(f) provides the acceptable methods for serving an individual or corporation located in a foreign country. Plaintiff’s mailing of the Summons and Complaint directly to TPC via Federal Express is not one of the accepted methods recognized by Rule 4 or, any other authorized or agreed form for service of process in Japan. Consequently, Plaintiff’s Complaint against TPC should be dismissed. Under Rule 4(f)(1), an individual may be served through “any internationally agreed means of service that is reasonably calculated to give notice, such as those authorized by the Hague Convention on the Service Abroad of Judicial and Extrajudicial Documents.” Fed. R. Civ. P. 4(f)(1). Plaintiff did not serve TPC under the means expressly provided by Japan under the Hague Convention, i.e., service through the Japanese Minister of Foreign Affairs. See Hague Convention, Practical Information on Japan, https://www.hcch.net/en/states/authorities/details3/?aid=261 (last visited March 3, 2017) (stating that formal service must be effectuated through the Minster of Foreign Affairs). In addition to service through the Hague Convention, Rule 4 authorizes service internationally, by another agreed upon method “prescribed by the foreign county’s law for service in that country in an action in its courts of general jurisdiction” (Rule 4(f)(2)(A)), “as the foreign authority directs in response to a letter rogatory or letter of request” (Rule 4(f)(2)(B), or if not prohibited by the foreign country’s law, by “delivering a copy of the summons and of the complaint to the individual personally” or “using any form of mail that the clerk addresses and send to the individual and that requires a signed receipt” (Rule 4(f)(2)(C)). Plaintiff did not serve TPC through the Hague Convention or any other internationally agreed method. Instead, service was attempted via international mail. As discussed above, service by mail on an international defendant in a Case 1:16-cv-01566-LJO-EPG Document 12-1 Filed 03/31/17 Page 5 of 9 5 15194304-v1 MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 foreign country, absent some authorized method of process through the Hague Convention or the law of the foreign country, is permitted in only a few limited circumstances identified under Rule 4: Service by international mail is affirmatively authorized by Rule 4(f)(2)(C)(ii), which requires that service be sent by the clerk of the court, using a form of mail requiring a signed receipt. Service by international mail is also affirmatively authorized by Rule 4(f)(3), which requires that the mailing procedure have been specifically directed by the district court. Service by international mail is not otherwise affirmatively authorized by Rule 4(f). Brockmeyer v. May, 383 F.3d 798, 808-09 (9th Cir. 2004). Plaintiff did not serve TPC through either of these accepted methods. In Brockmeyer, the Ninth Circuit addressed a similar situation and concluded that simply mailing a complaint and summons directly to an international defendant was insufficient to effect service: Plaintiffs neither followed the procedure prescribed in Rule 4(f)(2)(C)(ii) nor sought the approval of the district court under Rule 4(f)(3). They simply dropped the complaint and summons in a mailbox in Los Angeles, to be delivered by ordinary, international first class mail. There is no affirmative authorization for such service in Rule 4(f). The attempted service was therefore ineffective Id. As in Brockmeyer, Plaintiff’s mailing of the Complaint and Summons to TPC without transmitting said documents through the Clerk of Court or with approval or order of a District Court renders service of process on TPC ineffective. Plaintiff’s attempt at service via Federal Express is no better than first class mail because at least one court in this Circuit has concluded that service of process via Federal Express is defective in any form under Japanese law. In Fireman’s Fund Ins., Co. v. Fuji Elec. Sys. Co., 2005 WL 628034, at *3 (N.D. Cal. Mar. 17, 2005), the court concluded that even though Plaintiff properly arranged to have the summons and complaint served through the clerk of the court pursuant to Rule 4(f), service of process was still defective because the mailing was sent via Federal Express, which is expressly prohibited under Japanese law: Case 1:16-cv-01566-LJO-EPG Document 12-1 Filed 03/31/17 Page 6 of 9 6 15194304-v1 MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 [A]s noted, for Fireman's Fund's service of process to be proper, the manner of service (here, Federal Express delivery) must not be “prohibited by the law” of Japan. See Fed.R.Civ.Pro. 4(f)(2)(C)(ii). One line of cases interprets this phrase as barring all means of service not expressly allowed by the domestic law of the foreign country. See e.g., Graval v. P .T. Bakrie & Bros., 986 F.Supp. 1326, 1329 (C.D.Cal.1996); Procter & Gamble Cellulose Co. v. Viskoza-Loznica, 33 F.Supp.2d 644, 664-65 (W.D.Tenn.1998). Other courts have interpreted “prohibited by” to bar only those types of service that are expressly disallowed by the domestic law of the foreign country. See e.g., Dee-K Enterprises. Inc. v. Heveafil Sdn. Bhd., 174 F.R.D. 376, 379-80 (E.D.Va.1997); Resource Ventures, Inc. v. Resources Management Int'l, Inc., 42 F.Supp.2d 423, 429-30 (D.Del.1999). It is undisputed that the law of Japan forbids service of process by Federal Express delivery. (See Declaration of Yaeko Hodaka (“Hodaka Decl.”) ¶¶ 5-11.) Thus, under either line of authority, service by Federal Express was improper under Rule 4(f)(2)(C)(ii). Id. (emphasis added). Here, Plaintiff did not undertake the initial step under Rule 4(f) of having the Complaint and Summons served internationally by the Clerk of the Court. Even if she had, service via Federal Express would have been insufficient. Accordingly, Plaintiff’s Complaint against TPC must be dismissed. TPC expects Plaintiff will rely on Orms v. Takeda Pharmaceuticals America, Inc., 2010 WL 2757760 (E.D. Ky. July 12, 2010), in which the court there denied TPC’s motion to quash service of process sent directly to TPC through mail. Orms, however, is distinguishable because the decision was limited to an analysis of whether service by mail would be permitted by the Hague Convention. Although in Orms concluded that Japan did not object to service via mail under Article 10 of the Hague Convention, it did not analyze whether such service by mail would be sufficient under Rule 4(f). See Orms, 2010 WL 2757760 at *2 (“Additionally, although the Japanese delegation added the caveat that service of process via registered mail would be insufficient ‘in circumstances where the rights of the addressee were not respected[,]’ Takeda Limited has not argued that the Orms did not respect its right in serving it with process through the mail.”). Here, relying on the standards set forth by the Federal Rules, TPC does claim that its right were not respected. As discussed above, Rule 4(f)(C)(ii) requires that international service be effectuated through the clerk of the court to be Case 1:16-cv-01566-LJO-EPG Document 12-1 Filed 03/31/17 Page 7 of 9 7 15194304-v1 MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 proper. Moreover, Orms does nothing to discuss or distinguish Brockmeyer, the controlling law in this circuit or require a different result in this case. IV. CONCLUSION For the foregoing reasons, Plaintiff’s Complaint against TPC should be dismissed under Rule 12(b)(5) for insufficient service of process. Respectfully submitted, Dated: March 31, 2017 VENABLE LLP By: /s/ Celeste M. Brecht Celeste M. Brecht Attorneys for Defendants Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals International, Inc., Takeda Development Center Americas, Inc., Takeda Pharmaceuticals America, Inc. and Takeda Pharmaceutical Company Limited Case 1:16-cv-01566-LJO-EPG Document 12-1 Filed 03/31/17 Page 8 of 9 15194304-v1 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 PROOF OF SERVICE STATE OF CALIFORNIA ) ) ss. COUNTY OF LOS ANGELES ) I am employed in the County of Los Angeles, State of California. I am over the age of 18 and not a party to the within action; my business address is Venable LLP, 2049 Century Park East, Suite 2300, Los Angeles, California. On March 31, 2017, I served a copy / original of the foregoing document(s) described as MEMORANDUM IN SUPPORT OF TAKEDA PHARMACEUTICAL COMPANY LIMITED’S MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) on the interested parties in this action addressed as follows Melinda Davis Nokes, Esq. Weitz & Luxenberg 1880 Century Park East Suite 700 Los Angeles, CA 90067 Tel: (310) 247-0921 Fax: (310) 786-9927 Email: mnokes@weitzlux.com Attorneys for Plaintiff By placing true copies thereof enclosed in a sealed envelope(s) addressed as stated above. BY ELECTRONIC MEANS (FRCP 5(b)(2)(E)): Pursuant to FRCP 5(b)(2)(E), I served the above stated document by electronic means to the interested parties in this action whose names and e-mail addresses are listed above. I did not receive, within a reasonable time after the transmission, any electronic message or other indication that the transmission was unsuccessful. Service by e-mail or electronic means was agreed upon based on an agreement of the parties to accept service. I declare that I am employed in the office of a member of the Bar of this Court at whose direction the service was made. I declare under penalty of perjury under the laws of the United States of America that the above is true and correct. Executed on March 31, 2017, at Los Angeles, California. /s/ Celeste M. Brecht [Print Name] Case 1:16-cv-01566-LJO-EPG Document 12-1 Filed 03/31/17 Page 9 of 9 0 N W F a g oa ll oa ~~ y aa (,~ w V m a Y~' ~' Q J N Q d ~ O z ~ Z M ~ ¢w ~, ~ ZoW U 0 VENABLE LLP Celeste M. Brecht (SBN 238604) Email: cmbrecht@venable.com 2049 Century Parlc East, Suite 2300 Los Angeles, CA 90067 Telephone: (310) 229-9900 Facsimile: (310) 229-9901 Attorneys for Defendants Takeda Pharmaceuticals U.S.A., Inc., Talceda Pharmaceuticals International, Inc., Takeda Development Center Americas, Inc., Takeda Pharmaceuticals America, Inc. and Takeda Pharmaceutical Company Limited 1 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF CALIFORNIA 7 8 9 l0 1 1 SHARRON THOMAS, Plaintiff, V. 1~ 13 14 15 16 TAKEDA PHARMACEUTICALS USA, INC., TAKEDA PHARMACEUTICALS AMERICA, INC.; TAKEDA PHARMACEUTICALS INTERNATIONAL INC.; TAKEDA DEVELOPMENT CENTER AMERICAS, INC.; TAKEDA GMBH; TAKEDA PHARMACEUTICAL COMPANY LIMITED; TAKEDA PHARMACEUTICAL COMPANY LIMITED, Defendants. 17 18 19 20 21 22 23 24 25 26 27 28 CASE NO. 1:16-CV-01566-LJO-EPGx Hon. Lawrence J. O'Neill Courtroom 4 DECLARATION OF CELESTE M. BRECHT IN SUPPORT OF TAKEDA PHARMACEUTICAL COMPANY LIMITED'S MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) [Concurrently filed with Notice of Motion; Memorandum of Points and Authorities; and [P~oposedJ Order) DATE: May 4, 201.7 TIME: 8:30 a.m. CTRM: 4 Action Filed: October 14, 2016 Trial Date: None Set 1 5196197-v1 BRECHT DECL ISO MIN TO DISMISS FOR INSUFFICIENT SERVICE Case No. 1:16-CV-01566-LJO-EPGX Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 1 of 28 1 2 3 4 5 6 7 8 9 10 0 11 0 N W 12 °' = oa go °' 13-~Nao W W v m a ~WN 14Q J N d d ~ O '~a M 15W = ~, > ZgW 0 16 N 17 18 19 20 21 22 23 24 25 26 27 28 I, Celeste M. Brecht, hereby declare as follows: 1. I am a partner with the law firm Venable LLP, counsel for Defendants Talceda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals International, Inc., Takeda Development Center Americas, Inc., Takeda Pharmaceuticals America, Inc., and Takeda Pharmaceutical Company Limited in the above-entitled action. I ~' am an attorney licensed to practice before this Court. I have personal knowledge of the facts set forth herein and, if called as a witness, would competently testify thereto. 2. Counsel for Plaintiff ,Jonathan Sedgh, and I agreed that the deadline for Takeda Pharmaceutical Company Limited to respond to the Complaint would ~ be March 31, 2017. 3. Attached hereto as Exhibit A is a true and correct copy of a letter dated December 9, 2016 from Plaintiff's counsel, Weitz & Luxenberg, addressed to Talceda Pharmaceuticals Company Limited, enclosing a copy of the Summons and Complaint. I declare under penalty of perjury under the laws of the United States of America, that the foregoing is true and correct. Executed this 31St day of March, 2017, at Los Ang~;les~alifo Celeste M. 1 15196197-vt BRECHT DECL ISO MIN TO DISMISS FOR INSUFFICIENT SERVICE Case No. 1;16-CV-01566-LJO-EPGX Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 2 of 28 E IB T Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 3 of 28 y~~ Y.: '. ~ .!qry ~ ! d ~fL~L'~~t ~S. w .... g :e~~~. v `:'A.1 .Y.-r :A PRO. P~'E ~S' S; 1 i0 N~~Ai"L C 0 ~A P.Q R`~A~ T'I 0 N,~! . •~•~ :4. A':~NF ~~~'F~F ] G E'g :ice^3t cm. ,,rti+ ':700.t{[iOAD:~VAYi~ '.'•... NE4~~,,'}'f~RK~, 10003=9536 ; -;~'fE~~~fi~}2=53'S:y"5500'.; :~` _'s.q~, g"~1~'-~?AXi~1Z~94'i:5'4`61"~•: ..: _ ~. W~V~1~:~V~~I.T~i.U7C COM ''~`s..~_ ,. ~,(. .: " ,.,.. ^ ~. ....... '~~.'~..,~.~ ..~~ . .. m:.4f~ r y; ..i~ t '. o~y:f n ... .___.. .a..' .... .y .. .. ~< December 9, 2016 Via Federal Express Takeda Pharmaceuticals Company Limited Attn: Legal Department 1-1 Doshomachi 4-chome Chuo-Ku, Osaka, 540-0865, Japan Re: Proton Pump Inhibitor Litigation Thomas v. Takeda Pharmaceuticals USA Inc et al Case No. 1.16-cv-01566-LJO-EPG To Whom It May Concern: Enclosed far service upon you, please find a copy of the Complaint and Civil Cover Sheet, as well as a Summons for the case listed above. Very tnily yours, WEITZ & LUXENBERG, P.C. Enclosures cc: Stacey Dixon Calahan Assistant General Counsel, Litigafiion Takeda Pharmaceuticals U.S.A., Inc. One Takeda Parkway Deerfield, Illinois 60015 By: ~r Jonathan Sedgh, Esq. WEITZ & LUXENBERG, P.C. Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 4 of 28 Case 1:1.6-cv-01566-LJO-EPG Document 2 Filed 10/17/16 Page 1 of 3 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF CALIFORNIA SHARRON THOMAS , V. SUMMONS IN A CIVIL CASE TAKEDA PFiARMAC~UTTCALS USA, INC., ET AL. , CASE NO: 1:16-CV-OI566--LJO-EPG TO: Takeda Development Center Americas, Inc., Takeda GMBH, Takeda Pharmaceutical Connpany Limited Defendant's Address; Takeda Pharmaceutical Company Limited Attn: Legal Department 1-1 Doshomachi 4-chome Chuo-Ku, Osaka 540-8645, Japan YOU ARE HEREBY SUMMONED and required to serve on Melinda Davis Nokes Weitz & Luxenberg 1880 Century Park East, Suite 700 Los Angeles, CA 40067 an answer to the complaint which is served on you with this summons, within 21 days after service of this surrunons on you, exclusive of the day of service. If you fail to do so, judgment by default will betaken against you for the relief demanded in the complaint, Any answer that you serve on the parties to this action must be filed with the Clerk of this Court within a reasonable period of time after service. MARIANNE MATHERLY CLERK /s/ E. Tlores (By) DEPUTY CLERK ISSUED ON 2016-70--17 15:40:01.0, Clerk USDC EDCA Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 5 of 28 1544 cR~~. ~z,~Z~ ~~VTLOVER SHE '~' Case 1'16-cv-Q156~6-L,J PCB ocument 1-~ ~Ied.10~1~.4/~.6 Pa~e Z of 2 The JS 44 civil cover sheet and the mt`ormatian contnme herwn nwther rep ace nor supplement the fling an service o p.eadmgs or othe apers as required by luw, except as provided by local rules of court. This forrn, approved by the Judicial Conference of the United States in September ] 974, ~s required Cor the use of tha Clerk of Court for the purpose of initiating the civil docket sheet (SEEINSTRUCTIOA'SONNE\T PAGEOFTNISFORM.) I. (a) PLAINTTFFS SHARRON THOMAS (b) CounryofResidenceofFirstListedPlaintiff FRESNO COUNTY CA (EXCEPT IN U.S Plr1 fNTIFFCASBSJ ~C~ Attorneys (Finn Nanie, Address, and Teleplw~re Nwnbe~) DEFENAANTS TAKEDA PHARMACEUTICALS USA, INC.; TAKEDA PHARMACEUTICALS AMERICA, INC.; 7AKEDA PHARMACEUTICALS INTERNATIONAL, INC; TAKEDA DEVELOPM CounryofRcsidenceofFirstLis[edDefendanc LAKE COUNTY. IL (IN U.S PLAINTIFF CASES ONLYJ NOTE: IN LAND CONDEk1NAT10N CASFS, USE THE LOCATION OF THE TRACT OF 4AND INVOLVED. Attorneys (ljKnownJ Ti, BASIS OF JiJRISDTCTION(P/aceo~~^x"~no~~~eoxonh) III. CITIZENSHIP OF PRINCIPAL PARTIES~rta~sa~r'x'inOnesoxjorPlainq// (For Diversity Cares Only) and Onc Box jar Oefendu~~q d ] U.S. Government O 3 Federal Question PTf DF.R PTF DEF Plaintiff' (U.S Goveamten/ Nol a Parryj Citizen of This Stete 6S ] O I Limlporated or Principal Place O 4 d 4 ofBusincss h~ 77iis State O 2 U,S,Govemmrnl ~9 b Diversiry CirizenafAnmherState d 2 d 2 IncorpvrntcdmidPrineipalPlace O 5 (g 5 Defendant (Indicate Ctrizensl~ip ofPar7les br Ifexi !/!J of Business Tn Anodror State Citizen or Subject of a O 3 d 3 Foreign Nation O 6 O 6 Fami n Couniry 7V iV dTi1T2F (1F RTTiT ini,...,,..~ ~~v~•:., n.,,. u,,.. n.,i,~i IrAi l~fi [ lil sYai4~+CD.iE!1TSB$II R ~U i L . , PkiC<`ti41iRI51f6'FiS a`1?~if13U2~63~~[~iA1GTGA - '1. •e l - : 4a• iti ttY~(~i&~°i!A O 1101nsure~i~e PCRSONAL INJURY PERSONAL INJURY O G25 Drvg Rebated Seizure O 422 Appcnl 28 USC ISR O 375 False Claims Ace O 120 Marine O 310 Aimlm~a O 3G5 Personal h~jury - o(Properry 21 USC 881 O 423 ~Vitfidruwu! O A00 Stale Renpponionment O 130 Miller Act O 315 Ai~pinne Roduci Prod~ict Liability d 690 Othv 28 USC 157 d 410 Anlicrus~ D 140 Negotiable lnshument Liability ~ 367 Health Corel O 430 Banks and 6a~~king O 150 Recovery oCOverpayment d 320 Assault, Libel & Phnmmcalical ' 0 RT 2 fF O 450 Commerco Q 820 Copyriglus & enforcement ofJud}pvem Slander Personal Tnjt~ry d 4G0 peponatio~~ O 151 Medicare Act O 330 Federal Employers' Product Liability O 830 P¢tcnt O 470 Rackotett InOueneed and Q 152 Recovery of Defaulted SNdcnt Loons Liability O 368 Asbestos Personal O 340 Marine Injwy Product O B40 Tradcniark Corrupt Organizations d 480 Consumer Credit (Excludes Vcrornnsj O 153 RecoveryoiOveryoymenl Q 3A5 nfnrine Product Liability Liability PERSONAL PROPERTY f =' O 49U Cable/Sat TV O BSDSecurities/Conmiaditiea/O 710FairLaborStondards OSGIHIA(13955'Q a! Veteran's Benefits O 350 Motor Vel~icln O 370 Other Fraud Act O 862 BIacA Lung (923) Fxchuagc O IGO Srockholders' Sums O 190 Ocher Contract O 355 Motor Vehicle O 371 Truth in I.rnding Product Liability O 380 Ocher Personal O 720 Lebor/Mana4ement Relations O 863 DI WClD1W W (405(8)) O 8fi4 SSID Title XVf O S90 Ober Stemtory Actions O 691 Agricultural Acls O 195 Contract Product Liability O 360 OiherPersonal Prope~Ty Damage O 740 Raihvsy Labor Ac l O SGi RSI (405(8)) O H93 Environmental Matters O 196 Franchise Injury O 385 Propcity Damage q 751 Pemily azid Medical p 895 Fmedam oflnforniation O 362 Personal lujury- Product Liability Lcavc Act Act • Medical Mal rricrice O 790 Other Labor Li~igotion O 791 Employee Re~irement Income Security Act O 896 Arbip'alion O 899 Adminis~ti~~e Praoedure AcURevimv or Appeal of :̂ ~ Xf~It;T4 IY1CuTR"157~1f15f~t7 @~:RKS.O P~1 ~[ ~R~Ii~171iR41 O 2l0 LnnA Condemnation O 440 O~hcr Civil Rights Habeas Corpus: Q 870 Taxes (U.S. Plaintiff O 220 Foreclosure O 441 Votins O 4G3 Alien Detainee or Dtftnda~i~) Agency Decision Q 230 Rcnt Lcasc & Hjcctmcni O A42 Employment ❑ 510 ~lodans to Vucutc O 871 ]RS Third Aarty O 950 Constitutionality of O 240 Torts to Lurid O 443 Haisiry;/ Semence 2G USC 7609 State StnNtes O ~4i Ton Produu Li~biliry Accanmodatians O 530 Geneivl 14]I:GINO 290 All OtharRcal Property O 445 i4ner, ~v/bisabilities- O S35 Deatli Penalq~ O 462 Nauiralization ~lpplicotion~mploymnrt Other; d 44G Amer. rvlDisubilities- O S40 Mm~damus &Ocher ❑ 465 Other Gnmigration Ot6cr O 550 Civil Rights Actions O 44S Education O 555 Prison Condition O 560 Civil Delainee- Cunditions oC Canfincmcnt V. ORIGIN (Pluee an "X" br One Box Only) ~ 1 Original. O 2 Removed from O 3 Remanded Isom O 4 Reinstated or D i Transferted from Q 6 Multidistrict Proceeding State Court Appellate Court Reopened Another District Litigation !y ~lyl Cite die U.S. Civil Stntu[e under which ~~ou are filing (oo no~cfrejrrr;sdcrionalsrm~rres r~~+lau d7verstp): V1. CAUSE OF ACTION grief description of cause: Products liability litigation VII. REQUESTED IN 0 CHECK iF THIS IS i\ CLASS ACTION DEMANDS CI•IECK YES only if demanded in complaint: COMPLAINT: UNDER RULE 23, F.R.C~~.P. JURY DEMAND: ~I Yes O No VIII. RCLAT~D CASES) IP ANY fSee i+unvcrionej• BUDGE DOCKL-T NUMBER DATE SIGNATURE OF ATTORNEY OFR ECORD 10/14/2016 Melinda b. Kokes FOR OFFICE USE 0\LY RECEIPT# AMOUNT APPLI'INGIFP NDGE MAG.JUDGE Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 6 of 28 1544 Reverse (Rev, 12/12) Case 1:16-cv-01566-LJO-EPG Document 1-1 filed 10/x.4/16 Paqe 2 of 2 INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEETFORM JS 44 Authority For Civil Cover Sheet The JS 4Q civil cover sleet and the information contained herein neither replaces noc supplements the filings and service of pleading or other papers as required by law; except as provided by local ~vles of court. This form, approved by the Judicial Conference of die United States in September 1974, is required for the nse of the Clerk of Court for the purpose of initiating die civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of Court for each civil complaint filed. The attorney filing a case shottid complete the form as follows: I.(a) PlainHfts-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, use only the full name a• standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify fist the agency acid then the official, giving both name and tide. (b) County of Residence. Pox each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the time of filing. 1n U.S. plaintiff cases, enter tl~e came of die county in which the first listed defendant resides at the tine of tiling. (NOTE: In land condemnation cases, the county oFresidence of the "defendant" is the location of the u~act of land involved.) (c) Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, noting in this section "(see attachment)". II, Jurisdiction. Tie basis of}misdiction is set forth under Rule 8(a), P.R,Cv.P., which requires thatjurisdictions be sho~~n in pleadings. Place an "X" in one of the boxes. If there is more titan one basis of jurisdiction, precedence is given in the order sktown below. United States plaintiff. (1) Jurisdiction based on 28 U.S.C, 1345 and 1348. Suits by agencies and officers of the United States are incladed here. United States defendant. (2) When the plaintiffis suing the United States, its officers or agencies, place an "X" in this box. Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment to the Constitution, an act of Congress or a treaty of die United'States. Jn cases where the U.S. is a pazty, die U.S. plaintiff or defendant code takes precedence, and box I or 2 should be marked. Diversity of citizenship. (4) This t~efers to suits under 28 U.S.C. 1332: where parties are citizens of different stators. When Boa 4 is checked, the citizenship of the different parties must Ue checked. (See Section III below; NOTE: federal question actions take precedence over diversity cases.) III. Residence (citizenship) of Principal Parties. Tliis section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark this section for each principal ~~arty. 1V. Nature of Suit. Pace nn "X" in fire appropriate boa. If the nature of suit cannot be deterniined, be sure die cause of action, in Section VI Uelo~v, is sufficient to enable the deputy clerk or the statistical clerks) in file Administrative Office to determine the nature of suit. If Uie cause fits more LIiAn one nature of suit, select the most definitive. Origin. Place an "X" in one of the six boles. Original Proceedings. (1) Cases which originate in the United States district courts. Removed fi~om State Court. (2) Proceedings initiated instate courts mpy be removed to the district courts under Title 28 U.S.C., Section 144 1. When the petition for removal is granted, check this box. Remanded from Appellate Court. (3) Check this box for cases remanded to the district court for further action. Use file date of remand as the filing date. Reinstated or Reopened. (4) Check this box for cases reinstated or reopened in the dish•icl court. Use the reopening date as the filing date. Transfened from Another District. (5) For cases transfen•ed under Title 28 U.S.C. Section 1404(x), bo not use dill for within district transfers oc multidistrict litigation transfers. Multidistrict Litigation. (6) Check ll~is bos when a inultidistrict case is b~ansferred into the district under authority of Title 28 U.S.C. Section 1407. When Utis box is checked, do not check (5) above. Vl. Cause of Action, Report the civil statute directly related to file cause of action And give A brief description of file cause. Do not cite jurisdieHone] statutes unless diversity. Example: U.S. Civil Statute: 47 USC »3 Brief Aescription: Unauthorized reception of cable service VII. Requested [n Complaint. Class Action. Place an "X" in this box if you are Tiling a class action under Rule 23, F.R.Cv.P. Demand. In tills space enter the actual dollar amount being demanded or indicate other demand, such as a preliminary injunction, July bemand. Check the appropriate box to indicate whether or not ajury is bei~ig demanded. VIII. Related Cs~ses. This section of [he JS A4 is used to reference related pending cases, if s~ny. If there are related pending cases, insert t l~e docket numbers and file con•esponding judge Dames for such cases. Date and Attorney Signature. Date and sign file civil cover sheet. Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 7 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 1 of 20 WEITZ & LUXENBERG,1'.C, Attorney foz• Plaintiff 700 Broadway New York, New York 10003 Phone: (212) 558-5500 Facsimile: (212) 363-2721 Melinda D. Nokes (CA Bar #167787) mnokes @weitzlux.com Paul J. Pennock, Esc, ppennock @weitzlux.com Attorney for Plaintiffs IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DTSTRTCT OF CALIFORNIA SHARRON THOMAS, Plaintiff, v. COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL TAKEDA PHARMACEUTICALS USA, INC.; TAKEDA PHARMACEUTICALS AMERICA, INC.; TAKEDA PHARMACEUTICALS INTERNATIONAL, INC; TAKEDA DEVELOPMENT CENTER AMERICAS, INC.; TAKEDA GMBH; TAKEDA PHARMACEUTICAL COMPANY LTMTTED; TAKEDA PHARMACEUTICAL COMPANY LIMITED; Defendants. 1. Negligence 2. Strict Products Liability- Manufacturing Defect 3. Strict Product Liability-Design Defect 4. Strict Products Liability- Failure to Warn 5. Breach of Implied Warranty Plaintiff SHARRON THOMAS, by and through their attorneys of record, bring this action against Defendants TAKEDA PHARMACEUTICALS USA, INC.; TAKEDA PHARMACEUTICALS AMERICA, XNC.; TAKEDA PHARMACEUTICALS INTERNATIONAL, INC; TAKEDA DEVELOPMENT CENTER AMERICAS, INC,; TAKEDA GMBH; TAKEDA PHARMACEUTICAL COMPANY LIMITED; TAKEDA PHARMACEUTICAL COMPANY LIMITED; (collectively, "DEFENDANTS"). Plaintiff Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 8 of 28 Case 1;16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 2 of 20 alleges on information and belief, except for information based on personal knowledge, as follows: ,JURISDICTION AND VENUE 1. This Court has jurisdiction over this action pursuant to 28 U,S,C. § 1332, because the amount in controversy as to the Plaintiff exceeds $75,000.00, exclusive of interests and costs, and because Defendants are all incorporated and have their principal places of business in states other than the state in which the named Plaintiff resides. 2. Venue is proper in this Court pursuant to 28 U.S.C. § 1391 because a substantial part of the events giving rise to Plaintiffs' claims occurred, in part, in the Eastern District of California. DEFENDANT PARTIES 3. Defendant TAKEDA PHARMACEUTICALS USA, INC. is an Illinois corporation, which has its principal place of business at One Takeda Parkway, Deerfield, Illinois 60015. 4. Defendant TAKEDA PHARMACEUTICALS AMERICA, INC. is an Illinois coc~poration, which has its principal place of business at One Takeda Parkway, Deerfield, Illinois 60015. 5. Defendant TAKEDA PHARMACEUTICALS INTERNATIONAL, INC. is an Illinois corporation, which has its principal place of business at One Takeda Parkway, Deerfield, Illinois 60015. 6. Defendant TAKEDA DEVELOPMENT CENTER .AMERICAS, INC. is an Illinois corporation, which has its principal place of business at 208 South LaSalle Street, t Chicago Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 9 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 3 of 20 7. Defendant TAKEDA GMBH is a foreign corporation, which has its principal place of business at Byk-Gulden-Strasse 2, 78467 Konstanz, Germany. 8. Defendant TAKEDA PHARMACEUTICAL COMPANY LIMITED is a fox•eign corporation, which has its principal place of business at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka 540-8645. 9. On information and belief, TAKEDA PHARMACEUTICAL COMPANY LIMITED is either the dvect or indirect owner of substantially alI the stock or other• ownership interests of TAKEDA PHARMACEUTICALS USA, INC., TAKEDA PHARMACEUTICALS AMERICA, INC., TAKEDA PHARMACEUTICALS INTERNATIONAL, INC,, TAKEDA DEVET.OPMENT CENTER AMERICAS, INC, and TAKEDA GMBH. 10. Tn doing the acts alleged herein, said Defendants were acting in the course and scope of such agency, representation, joint venture, conspiracy, consultancy, predecessor agreement, successor agreement, service and employment, with knowledge, acquiescence, and ratification of each other (hereinafter TAKEDA PHARMACEUTICAL COMPANY LIMITED, TAKEDA PHARMACEUTICALS USA, INC., TAKEDA PHARMACEUTICALS AMERICA, INC., TAKEDA PHARMACEUTICALS INTERNATIONAL, INC., and TAKEDA DEVELOPMENT CENTER AMERICAS, INC, and TAKEDA GMBH are collectively referred to as "TAKEDA"). 11. On information and belief, Defendants have transacted and conducted business in the State of California, and/or contracted to supply goods and services within the State of California, and these causes of action have arisen from the same. 12. On information and belief, at all relevant times, Defendants expected or should have expected that their acts would have consequences within the United States of America and the State of California. Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 10 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Fifed x.0/14/16 Page 4 of 20 13. On information and belief, at all relevant times, Defendants derived and derive substantial revenue fi•om goods and products used in the State of California and from interstate commerce. 14. On information and belief, at all relevant times, Defendants committed tortious acts within the State of Califo~•nia causing injury within the State of California, out of which acts) these causes of action arise. PLAINTII+I+ 15. Plaintiff is a resident of the State California. 16. Before purchasing PPI, Plaintiff and Plaintiff's doctor were exposed to the advertising and muketing of Defendants. Plaintiff relied on the representations and warranties from Defendants made therein in making her decision to purchase Pl'Is and Prevacid, believing it would be safe and effective for its advertised use and relying on the expertise of Defendants. 17. Plaintiff ingested PPIs and Prevacid from approximately 1996 - 2016. 1$. At no time did Plaintiff take more than the recomnnended dosing regimen contained in the packaging and labeling of PPIs or Prevacid. 19, After taking the zecommended dosing of and as a result of PPIs and Prevacid manaf~ctured by Defendants, Plaintiff suffered Chronic Kidney Disease in approximately 2008 and Interstitial Neplv-itis in approximately 2010. SUMMARY OF THE CASE 20. As a result of the defective nature of PPIs, persons who ingested this product, including Plaintiff, have suffered and may continue to suffez• from kidney injuries including acute interstitial nephritis ("ATN"), acute kidney injuries ("AKI"), chronic kidney disease ("CKD") and ren~! failure, also known as end-stage renal disease ("ESRD") Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 11 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 5 of 20 21. Defendants concealed and continue to conceal their knowledge of PPIs' urueasonably dangerous risks from Plaintiff, his/her physicians, other consumers, and the medical community. Specifically, Defendants failed to adequately inform consumers and the prescribing medical community about the magnified risk of kidney injuries related to the use of 1'PTs. 22. As a result of Defendants' actions and inactions, Plaintiff was injured due to his/her ingestion of Pk'Is, which caused and will continue to cause Plaintiff's injuries and damages. Plaintiff accordingly seeks damages associated with these injuries. FACTUAL ALLEGATIONS 23. Ovei• 60 million Americans experience heartburn, a major symptom of GERD, at least once a month and some studies have suggested more than 15 million Americans experience heartburn on a daily basis. 24. AUout 21 million Americans used one or more prescription PPIs in 2009 accounting for nearly 20% of the drugs' global sales and ea~•ning an estimated $11 billion annually. 25. Upon infox•mation and belief, from 2003 to the present, PPIs have been one of the top ten best-selling and most dispensed forms of prescription medication in the United States each year. 26. PPIs are one of the most commercially successful groups of medication in the United States. Upon information and belief, between the period of 2008 and 2013, prescription PPIs had a sale of over $50 billion with approximately 240 million units dispensed. 27. Defendants, du•ectly oz• through then agents, apparent agents, servants, or employees designed, manufactured, marketed, advertised, distributed, promoted, and sold ~'PIs. Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 12 of 28 Case 1;16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 6 of 2d 28. In October of 1992, three years after the FDA's initial PPI approval, researchers fiom the University of Arizona Health Sciences Center led by Stephen Ruffenach published the first article associating PPI usage with kidney injuries in The American Journal of Medicine, followed by years of reports from national adverse drug registries describing this association. 29. In 2006, researchers at the Yale School of Medicine conducted a case series published in the International Society of Nephrology's Kidney International fording that PPI use, byway of AIN, left most patients "with some level of cluonic kidney disease." 30, On August 23, 2011, Public Citizen, a consumer advocacy group, filed a petition with the FDA to add black box warnings and other safety information concerning several risks associated with PPTs including AIN. 31. According to the petition, at the time of its filing there was "no detailed risk infoz-mation on any PPI for this adverse effect." 32. On October 31, 2014, more than three years after Fublic Citizen's petition, the FDA responded by requiring consistent labeling rega~•ding risk of AIN on all prescription Pl'Is, 33. The FDA noted "that the prescziption PPI labeling should be consistent with regard to this risk" and that "there is reasonable evidence of a causal association." 34, In December of 2014, the labels of prescription PPIs were updated to read: Acute interstitial nephritis has been observed in patients taking PPls inclacding (Brand]. Acute iraterstilial nephritis may occur at any poi~it during PPI therapy and is generally attribarted to an idiopathic ]rypersensitivity reaction. Discontinue (Brand] if acute interstitial Tzeplzritis develops. 35. The FDA did not require the consistent labeling regarding risk of AIN on over- the-counter PPIs. Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 13 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 7 of 20 36. In January of 2016, a study published in the Journal of the American Medical Associatr:on found that PPI use was independently associated with a 20 -- 50% higher risk of CKD. 37. In February of 2016, a study published in the Journal of the American Society of Neplzrology found that "exposure to PPI is associated with increased risk of development of CKD, progression of kidney disease, and risk of ESRD." 38. To date, over-the-counter PPIs lack detailed risk information for AIN. 39. To date, prescription and over-the-counter PPIs lack detailed risk information for CKD. 40. Parietal cells in the stomach lining secrete gastric juices containing hydrochloric acid to catalyze the digestion of proteins. 41. Excess acid secretion results in the formation of most ulcers in the gastroesophageai system and symptoms of hea~•tburn and acid reflux. 42. PPIs irreversibly block the acidic hydrogen/pot~ssium ATPase enzyme system (H-~-/K-t~ ATPase) of the gastz~ic parietal cells, the~•eby halting the production of most hydrochloric acid. 43. In spite of their commercial success and global popularity, up to 70% of PPIs may be used inappropriately for indications or durations that were never tested or approved. ~G. As a result of the defective natuze of PPIs, even if used as directed by a physician or healthcare professional, persons who ingested PPIs have been exposed to significant risks stemming fi~orn unindicated and/or long-term usage. 45. From these findings, PPIs and/or their metabolites -substances formed via metabolism -have been found to deposit within the spaces between the tubules of the kidney and Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 14 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Filed 10/14/x.6 Page 8 of 20 act in such a way to mediate acute interstitial nepYu•itis ("ATN"), a sudden kidney inflammation that can result in mild to severe problems. 46. PPI-induced AIN is difficult to dzagnose with less than half of patients reporting a fever and, instead, most commonly complaining of non-specific symptoms such as fatigue, nausea, and weakness. 47. In April 2016, a study published in the Journal of Nephrology suggested that the development of and failure to treat AIN could Iead to chronic kidney disease and end-stage renal disease, which requires dialysis or kidney transplant to manage. 48. CKll describes a slow and progressive decline in kidney function that may result in ESRD. As the kidneys lose their ability to function properly, wastes can build to high levels in the blood resulting in numerous, serious complications ranging from nerve damage and ~hea~~t disease to kidney failure and death, 49. Prompt diagnosis and rapid withdrawal of the offending agent are key in order to preserve kidney fiinction. While AIN can be treated completely, once it has progressed to CKD it is incurable and can only be managed, which, combined with the lack of numez~ous early-onset symptoms, highlights the need for screening of at-risk individuals. 50. Consumers, including the Plaintiff, who have used PPIs for the treatment of increased gastric acid have and had several alternative safer products available to treat the conditions and have not been adequately warned about the significant risks and lack of benefits associated with PPI therapy. 51. Defendants, tiu~ough their affirmative misrepresentations and omissions, actively concealed from Plaintiff and his/her physicians the true and significant risks associated with PPI use. Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 15 of 28 GasE 1:16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 9 of 20 52. Defendants concealed and continue to conceal their knowledge that PPTs can cause kidney injuries from Plaintiff, other consumers, and the medical community. Specifically, Defendants have failed to adequately inform consumers and the prescribing medical community against the serious risks associated with PPTs and have completely failed to warn against the risk of CKD and ESRD. 53. As a result of Defendants' actions and inactions, Plaintiff was injured due to his/her ingestion of PPIs, which caused and will continue to cause Plaintiff various injuries and damages. Plaintiff accordingly seeks damages associated with these injuries. 54. As a result of Defendants' actions, Plaintiff and his/her prescribing physicians were unaware, and could not have reasonably known or have lea~•ned through reasonable diligence, that Plaintiff had been exposed to the risks identified in this Complaint, and that those risks were the direct and proximate result of Defendants' acts, omissions, and misrepresentations. 55. As a direct result of ingesting PPIs, Plaintiff has been permanently and severely injured, having suffered serious consequences from PPI use. Plaintiff requires and will in the future require ongoing medical care and treatment. 56. Plaintiff, as a duect and proximate result of PPI use, suffered severe mental and physical pain and suffering and has and will sustain permanent injuries and emotional distress, along with economic less due to medical expenses, and living related expenses due to his/he r new lifestyle. 57. Plaintiff would not ]lave used PPIs had Defendants properly disclosed the risks associated with long-term use. COUNTI NEGLIGENCE Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 16 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 10 of 2d 58. Plaintiff incorporates by reference each and every prior paragraph of this Complaint as though set forth in full in this cause of action. 59. At all times herein mentioned, Defendants, had'a duty to exercise reasonable care in the research, development, testing for safety, research, formulation, manufacture, labeling, packaging, promotion, advertising, marketing, distribution, sale, and otherwise releasing into the stream of corrunerce PPIs and Prevacid. 60. Defendants breached their duty of reasonable care to Plaintiff in that they negligently designed, developed, manufactured, tested, inspected, packaged, promoted, marketed, distributed, labeled andlor sold PPIs and P~•evacid. Specifically, USP and DOES I-500 failed to exercise reasonable ca~•e in ways which included, but were not limited to, one or more of the following particulars: a. In their failure to warn or instruct and/or adequately warn or adequately instruct the public and consumers, including Plaintiff herein, of the dangerous and defective characteristics of PPIs and Prevacid; b. In then failure to warn or instruct and/or adequately warn ox adequately instruct the public and consumers, including Plaintiff herein, of the propensity of PPIs and Prevacid to cause kidney injuries including acute interstitial nephritis, acute kidney injuries, and cluonic kidney disease. c, In representing that PPIs and Prevacid was safe and effective for its intended use when, in fact, the product was unsafe for its intended use; d. In failing to perform appropriate, reliable and valid pre-market testing for safety of 1'PIs and Prevacid; e. In failing to perform appa•opriate post-market testing of PPIs and Prevacid; Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 17 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 11 of 2Q g. In failing to disclose to consumers and Plaintiffs adverse events received from FDA by users of 1'PIs and Prevacid; h. In failing to adequately represent the lack of research conducted on 1'1'Ts and Prevacid;and j. In fAiling to perform ~ppropz~iate post-market surveillance of PPIs and Prevacid. 61, Defendants, knew or should have known that consumers, such as Plaintiff herein, would foreseeably suffer injury as a result of the Defendants failure to exercise reasonable and ordinary care. 62. As a direct and proximate result of Defendant's carelessness and negligence, and of the unreasonably dangerous and defective characteristics of PPIs and Prevacid, Plaintiff suffered severe and permanent injuries. PlaintifF endured substantial conscious pain and suffering, both physical and emotional in nature. Plaintiff incurred significant expenses far medical care and treatment, suffered lost wages and earnings, and was otherwise physically, emotionally, and economically injured. Plaintiff sufrfered severe pecuniary loss. The injuries and damages alleged herein are permanent and will continue into the future. COUNT II STRICT PRODUCTS LIABILITY ~ MANUFACTURING DEFECT 63. Plaintiffs incorporate by reference each and every prior paragraph of this Complaint as though set forth in full in this cause of action. 64. At all times material to this action, DEFENDANT/S were responsible for designing, developing, researching, manufacturing, testing, packaging, promoting, marketing, Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 18 of 28 Case 1;16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 12 of 20 distributing, labeling, and/or selling, the PLAINTIFF PPUPPI, which is defective and urueasonably dangerous to users and/or consumers of the drug, including ~'laintiff. 65. At all times material to this action, PLAINTIFF PPI/PPI was manufactured, distributed, and/or sold by DEFENDANT/S in a defective and um•easonably dangerous condition, 66. In light of the potential and actual risk of harm associated with the product's use, a reasonable person who had actual knowledge of this potential risk of harm would have concluded PPIs and Prevacid should not have been marketed in that condition. 67. At all times relevant herein, Defendants knew that 1'FIs and Prevacid would be prescribed by docto~•s to members of the general public who would rely upon the representations made by Defendants on the product label and in their marketing including public statements and promotional and sales materials. 68. At all times material to this action, PPIs and 1'revacid were expected to reach, and did reach, consumers in the State of California and throughout the United States, including Flaintiff, without substantial change in the condition in which it was sold. 69. Defendants knew or should have known of the defective nature of PPIs and Prevacid, but continued to research, develop, design, test, manufacture, package, formulate, inspect, label, distribute, market, promote, sell and otherwise release this product into the stream of commerce so as to maximize sales and profits at the expense of the public health and safety, zn conscious disregard of the foreseeable harm caused by theix product, including serious medical side effects and injuries. 70. At all times, Plaintiff used PPIs and Prevacid for its intended or reasonably foz•eseeable purpose. Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 19 of 28 Case 1:x.6-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 13 of 20 71. As a duect and proximate result of the defective and unreasonably dangerous condition of PPIs and Prevacid and of its failure to perform safely, Plaintiff suffered injuries as set forth above. COUNT IIT STRICT PRODUCTS LIABILITY - DESIGN D~F~CT 72. Plaintiffs incorporate by reference each and every prior paragraph of this Complaint as though set fo~~th in full in this cause ~f action. 73. At all times material to this action, Defendants were responsible for designing, developing, researching, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, and/or selling, the PPIs and Prevacid, which is defective and um•easonably dangerous to users and/ox consumers of the drug, including Plaintiff. 7A~. At all times material to this action, PPIs and Prevacid was designed, developed, manufactured, tested, packaged, promoted, marketed, distributed, labeled, and/or sold by Defendants in a defective and urueasonably dangerous condition in ways which included, but were not limited ta, one or more of the following particulars: a. When placed in the stream of commerce, PPIs and Prevacid contained unreasonably dangerous design defects and was not reasonably safe and fit for its intended or reasonably foreseeable purpose or as intended to be used, thereby subjecting users and/or consumers of the product, including Plaintiff, to risks which exceeded the benefits of the product; b. The product did not perform as safely as an ordinary consumer would have expected it to perform when used in an intended or reasonably foreseeable way; Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 20 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 14 of 20 c. The product was insufficiently tested; d. The product caused harmful side effects that outweighed any potential utility; e. The product was more dangerous than other PPI's on the market; and £ The product was not accompanied by adequate labeling or instructions for use to fully apprise the public and consumers, including Plaintiff, of khe potential risks and serious side effects associated with its use, 75. In light of the potential and actual risk of harm associated with the product's use, a reasonable person who had actual knowledge of this potential risk of harm would have concluded PPIs and Prevacid should not have been marketed in that condition. 76. There existed safer alternative designs, but Defendants chose to market a more dangezous design. 77. At all times relevant herein, Defendants knew that PPIs and Prevacid would be prescribed by doctors to members of the general public who would rely upon the representations made by Defendants on the product label and in their muketing including public statements and promotional and sales materials. 78. At all times material to this action, l'PTs and Prevacid was expected to reach, and did reach, consumers in the State of California and tluoughout the United States, including Plaintiffs, without substanti~] change in the condition in which it was sold. 79. Defendants knew or should have known of the defective nature of PPIs and Prevacid but continued to z•eseaz•ch, develop, design, test, manufacture, package, formulate, inspect, label, distribute, market, promote, sell and otherwise release these products into the stream of commerce so as to maximize sales and profits at the expense of the public health and safety, in conscious disregard of the foreseeable harn~ caused by their prod~icts. Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 21 of 28 Case 1.16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 15 of 20 80. At all times, Plaintiff used PPIs and Prevacid for its intended or reasonably foreseeable purpose. 81. As a direct and proximate result of the defective and unreasonably dangerous condition of PPIs and Prevacid and of its failure to perform safely, Plaintiffs suffered injuries as set forth above. COUNT PV STRICT PRODUCTS LIABILITY -- I'AILURE TO WARN 82. Plaintiff incorporates by reference each and every prior paragraph of this Complaint as though set forth in full in this cause of action. 83. Al all times material to this action, Defendants were responsible for designing, developing, researching, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, and/or selling, the PPIs and Prevacid, which is defective and unreasonably dangerous to users and/or consumers of the drug, including Plaintiff. 84. At all times material to this action, PPIs and Prevacid were designed, developed, manufactured, tested, packaged, promoted, marketed, distributed, labeled, and/or sold by Defendants in a defective and urueasonably dangerous condition in ways which included, but were not limited to, one or more of the following particulars: a. it contained warnings insufficient to alert consumers, including Plaintiffs herein, of the dangerous risks andanjuries associated with PPIs and Prevacid, and the comparative severity, duration and the extent of the risks and injuries; b. it contained warnings insufficient to alert consumers, including Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 22 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 16 of 20 Plaintiff herein, of the propens9ty to cause a substantial inci•easecf risk of serious bodily harm. c. The warnings that were given by the Defendants were not detailed, clear, and/or were ambiguous. 85. Plaintiffs could not have discovered any defect in PPis and Prevacid through ehe exercise of reasonable care. 86. Defendants, as manufacturers, sellers and/or distributors of PPIs and Prevacid, are held to the level of knowledge of an expert in the field. 87. Plaintiff and Plaintiff's doctor reasonably relied on the skill, supezior knowledge, and judgment of Defendants. , 88. Defendants had a continuing duty to warn the Plaintiff of the dangers associated with the use of PPIs and 1'revacid. 89. Plaintiffs consumed and used PPIs and Prevacid for its intended purpose. 90. Had Plaintiff and Plaintiff's doctor received adequate warnings regarding the risks of PPIs and Prevacid, Plaintiff would not have used it. 91, As a direct and proximate result of the defective and inappropriate wa~•nings and the unreasonably dangerous and defective characteristics of PPIs and Prevacid, Plaintiff suffered injuries as set forth above. COUNT V BREACH OF IMPLIED WARRANTY 92. Plaintiffs incorporate by reference each and every prior paragraph of this Complaint as though set forth in full in this cause of action. Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 23 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Filed 10/~.~/1.6 Page 17 of 20 93. At all times material to this action, Defendants were responsible for designing, developing, researching, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, and/or selling, the PPIs and Prevacid, which is defective and unreasonably dangerous to users and/or consumers of the drug, including Plaintiff. 94. At the time of making these warranties, Defendants knew or should have known that, in fact, the representations and warranties were false, misleading, and untrue in that PPIs and Prevacid were not safe, effective and fit for use by consumers and users, including Plaintiff, for its intended use, that at was not of merchantable quality, that it did produce dangerous side efiFects, serious healtta conditions and that it was not adequately tested ox fit for its intended purpose. 95. Members of the public, including Plaintiffs, reasonably relied upon the skill and judgment of Defendants and upon said implied warranties in using PPIs and Prevacid. 96. Plaintiffs used PPIs and Prevacid for its intended purpose. 97. Defendants breached said implied warranties, in that, PPIs and ~'revacrd was not safe, effective and fit for its intended purpose, was not of merchantable quality, and, in fact, caused serious and potentially lethal side effects to consumers when taken in its recommended dose, and other injuries as herein alleged. 98. Due to Defendants wrongful conduct as alleged herein, Plaintiff could not have known about the nature of the risks and side effects associated with PPIs and Prevacid until after they used it. 99. As a direct and proximate result of the Defendants breach of implied warranties and the urueasonably dangerous and defective chaz•acteristics of PPIs and Prevacid, Plaintiff suffered injuries as set forth above, 1'UNITIVG DAMAGES ALLCGATIONS Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 24 of 28 Case 1:16-cv-01566-1.J~-EPG Document 1 Filed 10/14/16 Page 18 of 20 100. Plaintiffs incorporate by reference each and every prior paragraph of this Complaint as though set forth in full in this cause of action. 101. Beginning with PPIs and Prevacid, Defendants engaged in a course of conduct that included selling untested or• inadequately tested products, misrepresenting the safety and efficacy of those products, continuing to market products despite known safety concerns raised by federal agencies and otherwise engaging in a course of conduct that is ~•eprehensible. That conduct continued with the marketing of PPIs and Prevacid. 102. At all times material hereto, Defendants knew that the use of PPTs and 1'~~evacid could result in the development of serious harm and death. Additionally, Defendants knew that the use of PPIs and Prevacid would cause users, including Plaintiff, to suffer serious injury. 103. At all times material hereto, Defendants engaged in conduct that constitutes malice, oppression or fraud, including without limitation the misrepresentations, wa~•ranties and omissions set forth above. 104. Defendants continued to ma~~ket PPIs and Prevacid to consumers, including Plaintiffs, without disclosing the fact that use of PPIs and Prevacid could result in the development of serious injuries. Defendants did so knowing that their• failure to reveal the probable consequences of ingesting PPIs and Prev~cid would seriously injuz~e consumers, including Plaintiff, in order to make a pxofit and in so doing they acted with malice. 105. Defendants went further than failing to warn of PPIs and Prevacid defective and dangerous nature. They intentionally and falsely represented and warranted that PPIs were safe when they knew that, in fact, PPIs and P~•evacid was unsafe and posed a serious risk of injury to consumers, including Plaintiffs. They further concealed the true risks of PPIs and Prevacid as ~Ileged hezein. In so doing, they acted with fraud. Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 25 of 28 Case 1;16-cv-01566-LJO-EPG Document 1 Filed 10/14/16 Page 19 of 20 lOb, befendants continued to sell PPIs and Prevacid despite knowing the serious risk of injury posed to consumers. Such conduct is despicable and oppressive. 107. Defendants acts of malice, oppression and fraud were on the part of corporate officers, directors or managing agents, or were on the past of employees and were ratified or authorized by Defendants. ]08. Defendants intentional and/or reckless failure to disclose information deprived Plaintiffs of necessary information to enable PlaintifF to weigh the true risks of PPIs and Prevacid against the benefits in making their decision to use PFTs and 1'revacid. 109. As a direct and proximate result of the Defendants conscious and deliberate disregard for the rights and safety of consumers, Plaintiff suffered severe injury and loss. PlaintiFf likewise suffered loss as alleged herein. Plaintiff seeks actual and punitive damages ~.•om Defendants as alleged herein. 110. The aforesaid conduct of the Defendants was committed with knowing, conscious, and deliberate disregard for the rights and safety of consumers, including Plaintiff herein, thereby entitling Plaintiff to punitive damages in an amount appropriate to punish Defendants and deter them from similar conduct in the future, PRAYER FOR~tELIEF WHEREFORE, Plaintiff prays for judgment as follows: a. As to all Counts and all Defendants, damages to the Plaintiff according to proof including as applicable: i. Past and future medical and care expenses of Plaintiff according to proof; ii. Past and future loss of earnings (and profits) of Plaintiff according Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 26 of 28 Case 1:16-cv-01566-LJO-EPG Document 1 Filed 10/1.4/16 Page 20 of 20 to proof; iii. Other economic loss; b. As to all Counts and all Defendants, Non-economic damages according to proof including as applicable: i, Compensation for physical pain and discomfort; ii. Compensation for fright, nervousness, anxiety, worry, and apprehension; c. As to all Counts and all Defendants, awarding pre-judgment and post- judgment interest to the Plaintiff according to proof; d. As to all Counts and all Defendants, awarding reasonable costs to the Plaintiffs as provided by law; e. As to all Counts and all Defendants, awarding Plaintiffs punitive and treble damages; and f. As to all Counts and all Defendants, granting all such other relief as the Caurt deems necessary, just and proper. Date: October 14, 2016 /s/ Melinda D. Nukes Melinda D. Nokes.(167787) WEITZ & LUXENBERG, P.C. Attorney for Plai.nt~ 1880 Century Park East, #700 Los Angeles, CA 90067 Phone: (3l0) 247-0921 Facsimile: (310) 786-9927 mnokes @weitzlux.com Paul J. Pennock Paul J', Pennock W~ITZ & LUX~NB~RG, P.C. Attorney for Plaint 700 Broadway New York, New York 10003 Phone: (212) 558-5500 Facsimile; (212) 363-2721 ppennock @ weitzlux.com Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 27 of 28 PROOF OF SERVICE 0 NW~ ^ ~ ~~ ~0 r °'Q ao W U m Y a7 0~ ~ W N a W N a ~ o ~ ZM ~ a F N Z ~ W J Uma N a. a a Gsl a a z w STATE OF CALIFORNIA ss. COUNTY OF LOS ANGEL S ) I am employed in the County of Los Angeles, State of California. I am over the age of 18 and not a party to the within action; my business address is Venable LLP, 2049 Century Parlc East, Suite 2300, Los Angeles, California. On March 31, 2017, I served a copy Q / onganal ❑ of the foregoin~g~ ~d~ocuments) described as DECLARATION OF CELESTE M. BRECHT IN SUPPORT OF TAKEDA PHARMACEUTICAL COMPANY LIMITED'S MOTION TO DISMISS FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(5) on the interested parties in this action addressed as follows: Melinda Davis Nokes, Esq. Weitz & Luxenberg 1880 Century Parlc East Suite 700 Los Angeles, CA 90067 Tel: (310_) 247-0921 Fax: (310) 786-9927 Email: mnokes(a~weitzlux.com Attorneys fog Plaintiff ❑ By placing true copies thereof enclosed in a sealed envelopes) addressed as stated above. 2 3 4 5 6 7 8 9 10 1 1 12 13 14 Q BY ELECTRONIC MEANS (FRCP 5(b)(2)(E)): Pursuant to FRCP 5(b)(2)(E), I served the above stated document by electronic means to the interested parties in this action whose names and e-mail addresses are listed above. I did not receive, within a reasonable time after the transmission, any electronic message or other indication that the transmission was unsuccessful. Service by e-mail or electronic means was agreed upon based on an agreement of the parties to accept service. I declare that I am employed in the office of a member of the Bar of this Court at whose direction the service was made. I declare under penalty of perjury under the laws of the United States of America that the above is true and correct. Executed on March 31, 2017, at Los Angeles, California. /s/ Celeste M. Brecht Print ame 15 16 17 18 19 20 21 22 23 24 25 26 27 28 15196197-v1 Case 1:16-cv-01566-LJO-EPG Document 12-2 Filed 03/31/17 Page 28 of 28 15194798-v1 [PROPOSED] ORDER GRANTING OF MOTION TO DISMISSFOR INSUFFICIENT SERVICE, ETC. Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF CALIFORNIA SHARRON THOMAS, Plaintiff, v. TAKEDA PHARMACEUTICALS USA, INC., TAKEDA PHARMACEUTICALS AMERICA, INC.; TAKEDA PHARMACEUTICALS INTERNATIONAL INC.; TAKEDA DEVELOPMENT CENTER AMERICAS, INC.; TAKEDA GMBH; TAKEDA PHARMACEUTICAL COMPANY LIMITED; TAKEDA PHARMACEUTICAL COMPANY LIMITED, Defendants. CASE NO. 1:16-CV-01566-LJO-EPGx Hon. Lawrence J. O’Neill Courtroom 4 [PROPOSED] ORDER GRANTING MOTION TO DISMISS PLAINTIFF’S COMPLAINT FOR INSUFFICIENT SERVICE PURSUANT TO FEDERAL RULES OF CIVIL PROCEDURE 4(F) AND 12(B)(5) [Concurrently filed with Notice of Motion and Memorandum of Points and Authorities; Declaration of Celeste M. Brecht] DATE: May 4, 2017 TIME: 8:30 a.m. CTRM: 4 Action Filed: October 14, 2016 Trial Date: None Set Case 1:16-cv-01566-LJO-EPG Document 12-3 Filed 03/31/17 Page 1 of 2 1 15194798-v1 [PROPOSED] ORDER GRANTING OF MOTION TO DISMISS FOR INSUFFICIENT SERVICE, ETC. Case No. 1:16-CV-01566-LJO-EPGX 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 V E N A B L E L L P 2 0 4 9 C E N T U R Y P A R K E A S T , S U IT E 2 3 0 0 L O S A N G E L E S , C A 9 0 0 6 7 3 1 0 -2 2 9 -9 9 0 0 After considering the moving and opposition papers, any reply, arguments of Plaintiff Sharron Thomas and counsel (if any), and all other matters presented to the Court, IT IS HEREBY ORDERED that Plaintiff’s Complaint against TPC be dismissed under Rule 12(b)(5) for insufficient service of process. Dated: __________________ Honorable Lawrence J. O’Neill U.S. District Court Judge Case 1:16-cv-01566-LJO-EPG Document 12-3 Filed 03/31/17 Page 2 of 2
