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

MOTION to Dismiss for Lack of Jurisdiction

N.D. Cal.May 22, 2017

SANDOZ INC.’S AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609 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 GREENBERG TRAURIG, LLP LORI G. COHEN (admitted pro hac vice) SARA K. THOMPSON (admitted pro hac vice) Terminus 200 3333 Piedmont Road NE, Suite 2500 Atlanta, GA 30305 Telephone: (678) 553-2100 Facsimile: (678) 553-2212 cohenl@gtlaw.com thompsons@gtlaw.com NATASSIA KWAN (SBN 294322) 4 Embarcadero Center, Suite 3000 San Francisco, CA 94111 Telephone: (415) 655-1300 Facsimile: (415) 707-2010 kwann@gtlaw.com GREG SPERLA (SBN 278062) 1201 K Street, Suite 1100 Sacramento, CA 95814 Telephone: (916) 442-1111 Facsimile: (916) 448-1709 sperlag@gtlaw.com Attorneys for Defendants SANDOZ INC. and EON LABS, INC. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA EDWIN STREED; et al., Plaintiff, v. WYETH PHARMACEUTICALS, INC.; et al., Defendants. Case No. 3:17-cv-02609 DEFENDANTS SANDOZ INC.’S AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF Fed. R. Civ. P. 12(b)(6) Date: July 19, 2017 Time: 2:00 p.m. Judge: Hon. William H. Orrick Courtroom: 2, 17th Floor Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 1 of 33 i SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 NOTICE OF MOTION AND MOTION TO DISMISS ......................................................................... 1 STATEMENT OF THE ISSUES TO BE DECIDED ............................................................................. 1 STATEMENT OF FACTS ..................................................................................................................... 5 I. REGULATORY BACKGROUND ................................................................................ 5 A. The Federal Regulatory Framework for Generic Drugs. .................................... 5 B. Regulatory History of Amiodarone and Defendants. .......................................... 6 II. PLAINTIFFS’ CLAIMS AGAINST SANDOZ AND EON. ......................................... 7 ARGUMENT .......................................................................................................................................... 8 I. THIS COURT SHOULD DISMISS ALL CLAIMS AGAINST SANDOZ AND EON FOR LACK OF PERSONAL JURISDICTION. ......................................... 8 A. Plaintiffs Cannot Establish General Jurisdiction over Sandoz or Eon. ............... 8 B. Plaintiffs Cannot Establish Specific Jurisdiction over Sandoz or Eon. .............. 9 II. PLAINTIFFS FAIL TO STATE A CLAIM FOR FAILURE TO PROVIDE MEDICATION GUIDES AGAINST SANDOZ AND EON BECAUSE THEY DO NOT ALLEGE A BREACH OF ANY COGNIZABLE DUTY OWED TO THE PLAINTIFFS. ....................................................................................................... 11 III. ALL OF PLAINTIFFS’ CLAIMS ARE PREEMPTED BY FEDERAL LAW AND SHOULD THEREFORE BE DISMISSED......................................................... 13 A. Plaintiffs’ Claims Are All Preempted Failure-to-Warn Claims. ....................... 14 B. Plaintiffs’ Off-Label Promotion and Medication Guide Claims Are Also Impliedly Preempted and Subject to Dismissal. ....................................... 16 C. The Ninth Circuit and Northern District of California Have Dismissed Numerous Claims Like These Against Generic Manufacturers as Preempted. ......................................................................................................... 18 IV. PLAINTIFFS’ CLAIMS ARE INSUFFICIENTLY PLED. ......................................... 20 A. Plaintiffs Have Not Pled Their Off-Label Promotion Claims with the Particularity Required by FED. R. CIV. P. 9(b). .............................................. 20 B. Plaintiffs Improperly Base Their Off-Label Promotion Claims on Conduct Allegedly Undertaken by Entities Other than Defendants. ................ 22 V. PLAINTIFFS’ CLAIMS ARE BARRED BY THE STATUTE OF LIMITATIONS. ............................................................................................................ 23 Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 2 of 33 ii SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 VI. PLAINTIFFS’ CLRA CLAIM IS NOT YET ACTIONABLE BECAUSE PLAINTIFFS FAILED TO COMPLY WITH MANDATORY PRE-SUIT NOTICE PROVISIONS. .............................................................................................. 25 CONCLUSION ..................................................................................................................................... 25 Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 3 of 33 iii SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 Federal Cases Anderson v. Medtronic, Inc., No. 14-CV-00615-BAS, 2015 WL 2115342 (S.D. Cal. May 6, 2015) .......................................3, 19 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ....................................................................................................................4, 20 Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) ....................................................................................................................4, 20 In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., No. 05-1699 CRB, 2006 WL 2374742 (N.D. Cal. Aug. 16, 2006) ................................................19 Bristol-Myers Squibb Co. v. Super. Ct. of Cal., San Francisco Cnty., 137 S. Ct. 827 (2017) .....................................................................................................................10 Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) ..............................................................................................................3, 14, 16 Burger King Corp. v. Rudzewicz, 471 U.S. 462 (1985) ........................................................................................................................10 Chavez v. Dole Food Co., 836 F.3d 205 (3rd Cir. 2016) ......................................................................................................9, 11 Daimler AG v. Bauman, 134 S. Ct. 746 (2014) ....................................................................................................................8, 9 In re Darvocet, Darvon & Propoxyphene Products Liab. Litig., 756 F.3d 917 (6th Cir. 2014) ...........................................................................................................15 Drager v. PLIVA USA, Inc., 741 F.3d 470 (4th Cir. 2014) ...........................................................................................................15 Dreher v. Wyeth Pharm., Inc., No. 2:14-CV-00280, 2015 WL 3948961 (N.D. Ala. June 29, 2015) ..............................................22 Dunbar v. Medtronic, Inc., No. CV 14-01529-RGK, 2014 WL 3056026 (C.D. Cal. June 25, 2014) ..................................16, 19 Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674 (5th Cir. 2014) ...........................................................................................................15 Elliott v. Sandoz, Inc., No. 2:16-CV-00861-RDP, 2016 WL 4398407 (N.D. Ala. Aug. 18, 2016) …………………passim In re Fosamax Products Liab. Litig., 751 F.3d 150 (3rd Cir. 2014) ..........................................................................................................15 Frere v. Medtronic, Inc., No. 15-2338, 2016 WL 1533524 (C.D. Cal. Apr. 6, 2016) ............................................................19 Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011) ..............................................................................................................1, 2, 8, 9 Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 4 of 33 iv SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 Guarino v. Wyeth, 719 F.3d 1245 (11th Cir. 2013) .......................................................................................................15 Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal. 2013) ....................................................................................17, 19 Int'l Shoe Co. v. Washington, 326 U.S. 310 (1945) ..........................................................................................................................8 Johnson v. Teva Pharm. USA, Inc., 758 F.3d 605 (5th Cir. 2014) ...........................................................................................................15 Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC, 2014 WL 819392 (C.D. Cal. Feb. 14, 2014) .......................................19 Ko v. Mutual Pharm. Co., Inc., No. C13-00890-RMW, 2013 WL 5692375 (N.D. Cal. Oct. 18, 2013).....................................18, 19 Lashley & Del Valle v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014) ...........................................................................................................15 Lukovsky v. City & Cnty. of S.F., 535 F.3d 1044 (9th Cir. 2008) .........................................................................................................23 Martinez v. Aero Caribbean, 764 F.3d 1062 (9th Cir. 2014) ...........................................................................................................8 McDaniel v. Upsher-Smith Pharm., Inc., No. 2:16-cv-02604, 2017 WL 657778, (W.D. Tenn. Jan. 26, 2017) ..........................................7, 18 McLeod v. Sandoz, Inc., No.: 4:16-cv-01640-RBH, 2017 WL 1196801 (D.S.C. Mar. 31, 2017) .........................7, 14, 15, 22 Mellon Bank (East) PSFS, Nat. Ass’n v. Farino, 960 F.2d 1217 (3d Cir.1992) ............................................................................................................8 Minichino v. Wells Fargo Bank, N.A., No. C 11-01030 (SI), 2011 WL 4715153 (N.D. Cal. Oct. 7, 2011) ................................................24 Moretti v. Mutual Pharm. Co., 518 Fed. App’x 486 (8th Cir. 2013) ................................................................................................15 Moretti v. PLIVA, Inc., No. 2:08-cv-0396, 2012 WL 628502 (D. Nev. 2012) .....................................................................18 Moretti v. Wyeth, 579 F. App’x 563 (9th Cir. 2014) .............................................................................................15, 18 Motus v. Pfizer Inc., 196 F.Supp.2d 984 (C.D. Cal. 2001)...............................................................................................13 Mut. Pham. Co. v. Bartlett, 133 S. Ct. 2466 (2013) ......................................................................................................................3 Perdue v. Wyeth Pharm., Inc., 209 F. Supp. 3d 847 (E.D. N.C. 2016) .................................................................................... passim PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ................................................................................................................ passim Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 5 of 33 v SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 Plumlee v. Pfizer, Inc., No. 5:13-cv-00414-LHK, 2014 WL 4275519 (N.D. Cal. Aug 29, 2014) .......................................24 Rusk v. Sandoz Inc., No. A-14-cv-549-LY, 2015 U.S. Dist. LEXIS 179113 (W.D. Tex. Oct. 26, 2015) .............7, 14, 15 Stephens v. Teva Pharm. Inc., et al., 70 F. Supp. 3d 1246 (N.D. Ala. 2014) ..................................................................................7, 15, 16 Thomas v. Abbott Laboratories, No. CV12-07005-MWF, 2014 WL 4197494 (C.D. Cal. 2014) ......................................................13 Tutwiler v. Sandoz Inc., No. 2:16-cv-01246-LSC, slip op. (N.D. Ala. Mar. 9, 2017) ...........................................7, 14, 15, 22 Williams v. Yamaha Motor Co., 851 F.3d 1015 (9th Cir. 2017) .......................................................................................................8, 9 State Cases Bristol-Myers Squibb Co. v. Superior Court, 1 Cal. 5th 783 (2016) ........................................................................................................................9 Carlin v. Super. Ct. of Sutter Cnty., 13 Cal. 4th 1104 (1996) ............................................................................................................12, 13 Cnty. of San Diego v. Myers, 147 Cal.App.3d 417 (1983) .............................................................................................................23 Cooper v. Equity General Ins., 219 Cal.App.3d 1252 (1990) ...........................................................................................................21 Fox v. Ethicon Endo-Surgery, Inc., 35 Cal. 4th 797 (2005) ....................................................................................................................23 Howard Jarvis Taxpayers Ass’n v. City of La Habra, 25 Cal. 4th 809 (2001) ....................................................................................................................23 Lazar v. Super. Ct., 12 Cal. 4th 631 (1996) ....................................................................................................................21 McCann v. Foster Wheeler LLC, 48 Cal. 4th 68 (2010) ......................................................................................................................24 Norgart v. Upjohn Co., 21 Cal. 4th 383 (1999) ....................................................................................................................23 Outboard Marine Corp. v. Superior Court, 52 Cal.App.3d 30 (Cal. Ct. App. 1975) ..........................................................................................25 Stansfield v. Starkey, 220 Cal.App.3d 59 (1990) .........................................................................................................21, 22 Federal Statutes 21 U.S.C. § 331(d) ................................................................................................................................16 21 U.S.C. § 337(a) ........................................................................................................................ passim Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 6 of 33 vi SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 21 U.S.C. § 352(f) .................................................................................................................................16 21 U.S.C. § 355 .............................................................................................................................5, 6, 16 28 U.S.C. § 1631 ...................................................................................................................................11 State Statutes Ala. Stat. § 6-2-38 .................................................................................................................................24 Cal. Bus. & Prof. Code § 17200 ...........................................................................................................24 Cal. Bus. & Prof. Code § 17208 ...........................................................................................................24 Cal. Civ. Code § 1750 .......................................................................................................................4, 24 Cal. Civ. Code § 1782 ...........................................................................................................................25 Cal. Civ. Proc. Code § 335.1 .................................................................................................................24 Cal. Civ. Proc. Code § 338 ....................................................................................................................24 Cal. Civ. Proc. Code § 340.8(a) ............................................................................................................24 Cal. Civ. Proc. Code § 410.10 .................................................................................................................8 Cal. Health & Saf. Code § 111225 ........................................................................................................16 Ky. Rev. Stat. § 413.140(1)(a) ..............................................................................................................24 MCLA § 600.5805(13) .........................................................................................................................24 N.C.G.S.A. § 1-52(1)-(5) ......................................................................................................................24 N.C.G.S.A. § 1-52(16) ..........................................................................................................................24 O.C.G.A. § 9-3-33 .................................................................................................................................24 Ohio Rev. Code Ann. § 2305.10(A) .....................................................................................................24 S.C. Code Ann. § 15-3-530 ...................................................................................................................24 S.C. Code Ann. § 15-3-535 ...................................................................................................................24 Tenn. Code Ann. § 28-3-104 ................................................................................................................24 Tex. Civ. Prac. & Rem. Code Ann. § 16.003 ........................................................................................24 Rules 21 C.F.R. § 208.24 ....................................................................................................................12, 13, 17 21 C.F.R. § 314.50(c)(2)(i) ....................................................................................................................5 21 C.F.R. § 314.94(a)(8) ........................................................................................................................5 21 C.F.R. § 314.150(b)(10) ....................................................................................................................6 Fed. R. Civ. P. 4(k) .................................................................................................................................8 Fed. R. Civ. P. 8 ............................................................................................................................ passim Fed. R. Civ. P. 9(b) ....................................................................................................................... passim Fed. R. Civ. P. 12 .......................................................................................................................... passim Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 7 of 33 vii SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 Fed. R. Evid. 201(b)(6) ...........................................................................................................................6 Other Authorities FDA website at https://www.accessdata.fda.gov/scripts/cder/daf/ (last visited May 18, 2017) .................................................................................................................................................6 Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 8 of 33 1 SANDOZ INC.’S AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 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 NOTICE OF MOTION AND MOTION TO DISMISS PLEASE TAKE NOTICE that on July 19, 2017, at 2:00 p.m., or as soon thereafter as the matter may be heard before the Honorable Judge William H. Orrick in the United States District Court for the Northern District of California, Courtroom 2, located on the 17th Floor of the United States Courthouse, at 450 Golden Gate Avenue, San Francisco, California, Defendants Sandoz Inc. (“Sandoz”) and Eon Labs, Inc. (“Eon”) (collectively “Defendants”) will and hereby do move the Court to dismiss the action pursuant to Federal Rules of Civil Procedure 12(b)(2) and 12(b)(6) of the Federal Rules of Civil Procedure. Defendants move to dismiss the Amended Complaint on the ground of lack of personal jurisdiction and on the ground that the claims for relief asserted fail to state any cause of action upon which relief may be granted. Plaintiffs’ claims (1) do not allege a breach of any cognizable duty owed to Plaintiffs; (2) are all preempted by federal law; (3) are inadequately pled under Rules 8(a) and 9(b); (4) allege time-barred causes of action precluded by the statute of limitations; and thus fail to state a claim upon which relief may be granted. In addition, Plaintiffs’ CLRA claims are not yet actionable because Plaintiffs failed to comply with mandatory pre-suit notice provisions. This Motion is based on the accompanying Memorandum of Points and Authorities, the pleadings and papers filed herein, and the argument of counsel at the time of any hearing. STATEMENT OF THE ISSUES TO BE DECIDED In the Amended Complaint, sixty-two Plaintiffs bring claims against several pharmaceutical manufacturers, including Defendants, in connection with the prescription drug amiodarone hydrochloride (“amiodarone”), the generic equivalent of the brand name drug Cordarone®. Plaintiffs assert eight separate causes of action, but all essentially assert one of three theories predicated upon an alleged failure to warn of amiodarone’s risks: (1) failure to provide patient-directed Medication Guides to Plaintiffs directly, as purportedly required by federal regulations; (2) failure to otherwise adequately warn of the risks of generic amiodarone; or (3) knowing or intentional misrepresentation of the safety and efficacy of amiodarone products through off-label promotion. As numerous other courts have found in very similar cases involving amiodarone filed by the same Plaintiffs’ counsel, the Amended Complaint should be dismissed as to Defendants for four reasons. Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 9 of 33 2 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 First, this Court lacks personal jurisdiction over Defendants - neither of which is incorporated in or has a principal place of business in California - because fifty-six of the sixty-two Plaintiffs reside outside of California (“non-resident Plaintiffs”), and of the six who allegedly reside in California, none pled facts sufficient to establish a connection between Sandoz or Eon to the forum state.1 Two types of personal jurisdiction may be exercised in accordance with due process: general or “all-purpose” jurisdiction, and specific or “case-linked” jurisdiction. Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 919 (2011). There is no general jurisdiction over Sandoz or Eon for any Plaintiff’s claims because Sandoz is incorporated in Colorado2 and Eon is incorporated in Delaware, and both have principal places of business in New Jersey. Am. Compl. ¶¶ 41-42. There also is no specific jurisdiction over Sandoz or Eon as to the non-resident Plaintiffs’ claims that have no connection to the State of California, including any connection as loci delicti commissi or loci actus, nor have they pled any such connection. See Goodyear, 564 U.S. at 923-24. Of the six California resident Plaintiffs, none more than vaguely allege they purchased, ingested or were injured by any specific defendant’s amiodarone. Accordingly, pursuant to Rule 12(b)(2), the Court should dismiss all claims against Sandoz and Eon for lack of personal jurisdiction. Second, the Amended Complaint fails to plead all necessary elements of any cause of action premised on an alleged violation of a duty to provide a Medication Guide to patients, because no such duty exists under state or federal law. Regardless of how titled, Plaintiffs cannot build a viable cause of action out of alleged failure to deliver Medication Guides because under the “learned intermediary” doctrine, no such obligation to deliver warnings directly to patients exists under state law, and the governing federal regulation only requires that manufacturers such as Defendants either distribute or make available Medication Guides to “authorized dispensers,” which are pharmacies and distributors. The mere fact that a patient allegedly did not receive a Medication Guide from his/her pharmacist with his/her prescription does not suggest any breach of duty by the manufacturer and does not give rise to a cognizable claim. 1 Besides the first plaintiff, Streed, who alleges the use of products from all manufacturer defendants, the four plaintiffs who specifically allege use of products manufactured by Sandoz or Eon are: Jerome Cobb, of Alabama; Sandra Rhodes and Charles Rhodes, of Alabama; and Ernestine Salvo, of South Carolina. Am. Compl. ¶¶ 4-6. 2 Sandoz’ state of incorporation is incorrectly described in the Amended Complaint as New Jersey. Am. Compl. ¶ 41. In fact, Sandoz is incorporated in Colorado and has a principal place of business in New Jersey. Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 10 of 33 3 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 Third, all of Plaintiffs’ theories of liability as to Defendants are preempted by federal law. Claims sounding in failure to warn that attack the sufficiency or accuracy of the FDA-approved labeling for a generic drug product are preempted under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). Even if Plaintiffs attempt to distinguish their claims from traditional failure to warn claims by arguing their primary claims are off-label promotion of amiodarone and failure to ensure delivery of Medication Guides to patients, these claims exist solely by virtue of federal statutes and regulations and are therefore still impliedly preempted because 21 U.S.C. §337(a) makes clear that only the federal government, not private litigants, may enforce the Food, Drug and Cosmetic Act and its regulations. Plaintiffs cannot hold Defendants liable for purportedly inadequate warnings for a generic drug manufactured and distributed pursuant to an Abbreviated New Drug Application (“ANDA”) approved by the FDA3 because federal regulations prohibit any deviation from approved marketing and labeling, including allegedly deficient warnings for alleged “off-label” promotion. See, e.g., Anderson v. Medtronic, Inc., No. 14-CV-00615-BAS, 2015 WL 2115342, at *6 (S.D. Cal. May 6, 2015) (off-label promotion claims preempted under Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001)). In Mensing, the Supreme Court held state law tort claims premised on alleged failure to warn of the risks of generic drugs irreconcilably conflict with and thus are preempted by federal law requiring generic manufacturers to conform their warnings to the equivalent brand name product. Mensing, 564 U.S. at 608-09; see also Mut. Pham. Co. v. Bartlett, 133 S. Ct. 2466, 2480 (2013) (extending Mensing to design defect claims). Furthermore, to the extent Plaintiffs’ claims allege failure to comply with federal statutes or regulations governing the content of labeling, dissemination of Medication Guides, or promotion of FDA-approved drug products for unapproved uses, such claims premised upon alleged violations of the Food, Drug, Cosmetic Act (“FDCA”) would be prohibited by 21 U.S.C. § 337(a), which bars private enforcement of the FDCA. See Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). 3 Plaintiffs’ warnings-based allegations include:  “…[T]he Cordarone®/Amiodarone, manufactured and/or supplied by Defendants to Plaintiffs was and is unaccompanied by proper warnings regarding all possible adverse side effects and comparative severity and duration of such adverse effects and the required Medication Guides. . . . This is particularly so with regard to ‘off-label’ use.” Am. Compl. ¶ 121. See also Am. Compl. ¶¶ 122, 129. Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 11 of 33 4 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 Fourth, Plaintiffs fail to plead their claims with the factual support required by Fed. R. Civ. P. 8(a) and, as to fraud-based claims, including claims of off-label promotion, with the particularity required by Rule 9(b). The Amended Complaint is rife with conclusory statements (e.g., “[T]he warnings for Cordarone®/Amiodarone in effect during the relevant time period absent the Medication Guide were vague, incomplete, and/or otherwise wholly inadequate . . . .” (Am. Compl. ¶ 129)), but devoid of the necessary factual allegations to support such conclusions. Fifty-eight Plaintiffs have also failed to even allege that Sandoz or Eon manufactured, distributed, sold, or promoted the specific amiodarone product they ingested. Rather, they allege only that they used amiodarone manufactured by other defendants or received product manufactured by “Generic Defendants” or “potentially other Generic Defendants,” see, e.g., Am. Compl. ¶¶ 4(c), 5(d), 6(d), or a list of several generic defendants separated by “and/or,” see id. ¶ 1(c). “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice,” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009), and where the court cannot infer more than the mere possibility of misconduct, the complaint has not “show[n] that the pleader is entitled to relief.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 557 (2007). Moreover, Plaintiffs fail to meet the heightened standard of specificity that applies to all fraud-based claims, not just the Fifth Cause of Action for fraud and deceit, but also any conclusory allegations made in support of other causes of action such as allegations pled in blanket fashion against all defendants alleging they “[p]urposefully downplay[ed] and understat[ed] the health hazards and risks associated with the Amiodarone,” Am. Compl. ¶ 193. Several individual causes of action set out in the Amended Complaint also require dismissal for independent reasons. As to the Seventh Cause of Action, Plaintiffs have failed to provide the 30- day notice to Sandoz and Eon, which is a jurisdictional prerequisite to monetary damages claims under California’s Consumer Legal Remedies Act, Cal. Civil Code §§ 1750 et seq. (“CLRA”). Further, Plaintiffs’ First, Second, Third, Fourth, and Seventh Causes of Action for strict liability, negligence, and CLRA violations are all time-barred due to the applicable two-year or three-year statute of limitations. Numerous individual Plaintiffs’ claims are also time-barred on their face. For all of the foregoing reasons, and as set forth below, Plaintiffs’ claims against Defendants should be dismissed with prejudice and without leave to amend. Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 12 of 33 5 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 STATEMENT OF FACTS I. REGULATORY BACKGROUND A. The Federal Regulatory Framework for Generic Drugs. Pursuant to the federal Food, Drug and Cosmetic Act (“FDCA”), the United States Food and Drug Administration (“FDA”) regulates the approval of both brand name and generic drugs. See 21 C.F.R. §314.50(c)(2)(i) (brand name); 21 C.F.R. §314.94(a)(8) (generic). A manufacturer seeking approval to market a new drug must first show it is safe and effective and its proposed labeling is accurate and adequate, through the filing of a New Drug Application (“NDA”). Mensing, 564 U.S. at 612. This approval process for brand name drugs involves costly and lengthy clinical testing. Id. In contrast, generic drugs are “designed to be a copy of a Reference Listed Drug (typically a brand name drug), and thus identical in active ingredients, safety and efficacy.” Id. Generic manufacturers obtain FDA approval to manufacture and sell generic drug products under the regulatory framework set forth in what are commonly known as the Hatch-Waxman Amendments (“Hatch-Waxman”), 21 U.S.C. §355(j)(2)(A). Id. Hatch-Waxman changed the approval requirements for generic drugs to require only submission of an Abbreviate New Drug Application (“ANDA”) to show a generic drug is therapeutically equivalent to a previously-approved NDA, i.e., a brand name drug. 21 U.S.C. §355(j)(2)(A). Hatch-Waxman also requires that the “labeling proposed [for an ANDA] is the same as the labeling approved for the brand-name drug.” Mensing, 564 U.S. at 605. To receive FDA approval, an ANDA applicant need not demonstrate its warnings are accurate and adequate, but only that its “warning label is the same as the brand name’s.” Id. at n.3. The only duty incumbent upon a generic manufacturer under federal law with respect to its warnings is an ongoing duty of “sameness”-to ensure its generic drug’s labeling remains identical to the RLD. Id. at 613. Generic manufacturers are prohibited from independently changing their labeling without prior FDA approval. Id. at 616-617; see also 21 C.F.R. §314.150(b)(10) (authorizing FDA to revoke approval of a generic drug if its labeling “is no longer consistent with that for the [reference] listed drug”). For a generic manufacturer to independently change its warning labeling, even to strengthen it, would violate federal law. Mensing, 564 U.S. at 617. Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 13 of 33 6 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 This duty of sameness also extends to the drug’s design. Generic manufacturers must show their products are therapeutically equivalent to the Reference Listed Drug. See 21 U.S.C. §§ 355(j)(2)(A)(i)-(iii) (must demonstrate a generic drug contains the same active ingredient(s); employs the same route of administration; presents the same dosage form; and exhibits the same strength as its brand name counterpart). Federal law requires a generic to be “identical [to its Reference Listed Drug equivalent] in active ingredients, safety, and efficacy,” just as each generic drug must “ensur[e] that its warning label is the same as the brand name’s.” Mensing, 564 U.S. at 613 n.3. B. Regulatory History of Amiodarone and Defendants. Amiodarone hydrochloride is a prescription pharmaceutical product indicated for treatment of recurrent ventricular arrhythmias (recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia) when other treatments are ineffective or have not been tolerated. It was first manufactured and sold by Wyeth under the brand name Cordarone® in 1985. Plaintiffs assert they were prescribed a 200, 400, or 800 mg daily dose of amiodarone tablets for treatment of atrial fibrillation. Am. Compl. ¶¶ 1-39, sub.(d). Eon Labs Manufacturing, Inc. (now known as Eon Labs, Inc. (“Eon”)) obtained ANDA approval to manufacture generic amiodarone 200 mg tablets on December 23, 1998.4 Eon was required to submit an ANDA (#75315) to FDA, demonstrating bioequivalence to Cordarone® and proposed labeling that was materially identical to the Cordarone® labeling. 21 U.S.C. §355(j)(2)(A). The FDA reviewed and approved the proposed labeling, determining it was materially identical to Cordarone®.5 Eon was acquired by Sandoz in 2005 and transferred ANDA #75315 to Sandoz. Federal law required Eon and later Sandoz to keep the labeling, which as of 2005 included a patient- directed Medication Guide, and design of their ANDA-approved amiodarone products consistent with the approved labeling and design for Cordarone®. Mensing, 564 U.S. at 624-25. 4 Information on ANDA #75315 may be found on the FDA website at www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=075315 (last visited May 18, 2017). A true and correct copy of the website is attached as Exhibit A. A true and correct copy of the FDA approval letter for ANDA #75315 is attached as Exhibit B. The Court may take judicial notice of public records and government websites in deciding a motion to dismiss under Rule 12(b)(6). See FED. R. EVID. 201(b)(6). 5 Plaintiffs’ claims directly conflict and are inconsistent with federal statutes and FDA regulations and are thus preempted. Defendants request that this Court dismiss the Amended Complaint with prejudice, taking into consideration Sandoz’ publicly-filed ANDA and FDA documents available on the FDA website, attached as Exhibits A and B. Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 14 of 33 7 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 II. PLAINTIFFS’ CLAIMS AGAINST SANDOZ AND EON. On May 1, 2017, Plaintiffs filed their Amended Complaint asserting essentially three theories of liability: (1) they each “did not receive the required Medication Guide from Defendants for the [amiodarone] prescriptions” and were “not provided up to date warning labels that would have warned [them] of the serious, potentially life-threatening, side-effects of Amiodarone,” Am. Compl. ¶¶ 1-39, sub.(f); (2) amiodarone “was and is unaccompanied by proper warnings” and “was defective due to inadequate post-marketing warning and instruction,” id. ¶¶ 121, 125; and (3) defendants “simultaneously engaged in a massive and illegal marketing and promotional scheme in which they aggressively and illegally promoted…amiodarone for uses never authorized by the FDA” and “actively promoted their generic amiodarone in the stream of commerce for the ‘off-label’ uses openly promoted by Wyeth,” id. ¶¶ 118, 126. Defendants deny these allegations and claims as supported in neither fact nor law. Each of these claims, at their root, seeks to privately enforce alleged violations of federal statutes and regulations governing manufacturers of prescription pharmaceuticals, and each is squarely preempted by federal law. Notably, these claims are identical to other generic amiodarone product liability claims that other federal district courts have dismissed. See, e.g., McDaniel v. Upsher-Smith Pharm., Inc., No. 2:16-cv-02604, 2017 WL 657778, (W.D. Tenn. Jan. 26, 2017) (dismissing failure to warn and negligence claims as preempted); McLeod v. Sandoz, Inc., No.: 4:16-cv-01640-RBH, 2017 WL 1196801, at *6 (D.S.C. Mar. 31, 2017) (holding that attempts to require Sandoz to “change the warning label or disseminate additional warnings to reflect the alleged additional dangers associated with the ‘off-label’ use or . . . exit the market place . . . requires preemption under Mensing and Bartlett”); Rusk v. Sandoz Inc., No. A-14-cv-549-LY, 2015 U.S. Dist. LEXIS 179113 (W.D. Tex. Oct. 26, 2015) (dismissing products liability claims as preempted as a matter of law); Stephens v. Teva Pharm. Inc., et al., 70 F. Supp. 3d 1246 (N.D. Ala. 2014) (dismissing all claims); Perdue v. Wyeth Pharm., Inc., 209 F. Supp. 3d 847 (E.D. N.C. 2016) (dismissing claims as impliedly preempted); Elliott v. Sandoz, Inc., No. 2:16-CV-00861-RDP, 2016 WL 4398407, at *9 (N.D. Ala. Aug. 18, 2016) (dismissing failure-to-warn and medication guide claims as preempted); Tutwiler v. Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 15 of 33 8 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 Sandoz Inc., No. 2:16-cv-01246-LSC, slip op. (N.D. Ala. Mar. 9, 2017) (dismissing medication guide claims as preempted). ARGUMENT I. THIS COURT SHOULD DISMISS ALL CLAIMS AGAINST SANDOZ AND EON FOR LACK OF PERSONAL JURISDICTION. Plaintiffs bear the burden of showing personal jurisdiction is proper by presenting “a prima facie case for the exercise of personal jurisdiction by establishing with reasonable particularity sufficient contacts between the defendant and the forum state.” Mellon Bank (East) PSFS, Nat. Ass’n v. Farino, 960 F.2d 1217, 1223 (3d Cir.1992). Federal Rule of Civil Procedure 4(k) only allows personal jurisdiction over non-resident defendants to be exercised to the extent it is authorized by the laws of the state in which the federal court sits. Martinez v. Aero Caribbean, 764 F.3d 1062, 1066 (9th Cir. 2014). California’s long arm statute permits personal jurisdiction over a non-resident defendant to the extent it is permitted by the Constitution. Cal. Code Civ. Proc. § 410.10. Therefore, a court must determine whether a non-resident defendant has “certain minimum contacts with [California] such that the maintenance of the suit does not offend traditional notions of fair play and substantial justice.” Int'l Shoe Co. v. Washington, 326 U.S. 310, 316 (1945) (internal quotation omitted). There are two manners in which plaintiffs may obtain personal jurisdiction: (1) general jurisdiction, or (2) specific jurisdiction. Plaintiffs here cannot satisfy their burden of alleging “sufficient contacts between [Sandoz and Eon] and the forum state” to establish either. Williams v. Yamaha Motor Co., 851 F.3d 1015, 1021-23 (9th Cir. 2017). A. Plaintiffs Cannot Establish General Jurisdiction over Sandoz or Eon. In Daimler AG v. Bauman, 134 S. Ct. 746 (2014), the Court held that general personal jurisdiction exists only where the defendant’s “affiliations with the [forum] State are so ‘continuous and systematic’ as to render [it] essentially at home” there. Id. at 754 (quoting Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 919 (2011)). A corporation is deemed at “home” in the states where it is incorporated and has its principal place of business. Daimler 134 S. Ct. at 760. While general jurisdiction is not limited solely to these “paradigm” locations, a corporation will not be subject to general jurisdiction in a state merely because it “engages in a substantial, continuous, Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 16 of 33 9 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 and systematic course of business” there. Id. at 760-61. In fact, courts have held “it is incredibly difficult to establish general jurisdiction [over a corporation] in a forum other than the place of incorporation or principal place of business.” Chavez v. Dole Food Co., 836 F.3d 205, 223 (3rd Cir. 2016). A company will not be “at home” if it “is not incorporated there, does not maintain an office there, and does not supervise its business there.” Id. at 223. Instead, a corporation may be subject to general jurisdiction outside the state where it is incorporated and has its principal place of business only in an “exceptional case.” Id. at 230. Here, Plaintiffs allege that Sandoz is a company incorporated in a foreign state with a principal place of business in New Jersey, and (incorrectly) that Eon’s principal place of business is in New York. Am. Compl. ¶¶ 41, 42. Plaintiffs do not allege that either Sandoz or Eon maintain an office or principal place of business in California. While Plaintiffs also allege that Sandoz and Eon do business in California, that alone is not sufficient under Daimler to deem Sandoz and Eon “at home” in this jurisdiction. Daimler, 134 S. Ct. at 760. Accordingly, Sandoz and Eon are not subject to general jurisdiction in California and personal jurisdiction over Sandoz and Eon does not exist on this basis. B. Plaintiffs Cannot Establish Specific Jurisdiction over Sandoz or Eon. To establish specific jurisdiction, a plaintiff must demonstrate all of the following: (1) the defendant purposefully directed its activities at residents of the forum; (2) the litigation results from alleged injuries that arise out of or relate to those activities directed at forum residents; and (3) the exercise of jurisdiction comports with fair play and substantial justice. Yamaha Motor Co., 851 F.3d at 1023. While Sandoz and Eon do sell their amiodarone product to pharmacies and distributors in California (and every other state), the Amended Complaint fails to establish the second and third prerequisites for specific jurisdiction. Id. As to the second requirement, a court cannot exercise specific jurisdiction over an out-of-state defendant, even one with “minimum contacts” with the forum state, where the “episode-in-suit” occurred outside the forum.6 See Goodyear, 564 U.S. at 919-20. Here, the Amended Complaint fails 6 The California Supreme Court’s decision in Bristol-Myers Squibb Co. v. Super. Ct., in which the Court held that a California court could exercise specific jurisdiction over a drug manufacturer notwithstanding that the claims there did Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 17 of 33 10 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 assert facts sufficient to connect any relevant activity by Sandoz or Eon to the State of California. The fifty-six non-resident Plaintiffs cannot establish specific jurisdiction, nor do they attempt to allege it in the Amended Complaint, because their claims do not “arise out of or relate to” any alleged contacts with, or activity in, the State of California. In fact, fifty-six of the sixty-two Plaintiffs reside outside of California so any alleged activities involving such plaintiffs would have no bearing on jurisdiction here. Further, the remaining six California-based Plaintiffs’ vague, conclusory allegation that their claims “arise in part out of the Defendants’ commercial activities within the State of California” (Am. Compl. ¶ 57) does not show that their specific claims arise out of or relate to purported contacts with California. They do not allege that Sandoz or Eon specifically marketed amiodarone to any particular physician or pharmacy in California and they simply allege that all defendants marketed to all prescribing physicians and pharmacies. The majority of Plaintiffs, including the six California residents, do not specifically allege they ingested amiodarone manufactured by Sandoz or Eon at all. Rather, they allege only that they were prescribed and received amiodarone manufactured by other specific defendants, or they received product manufactured by “Generic Defendants” or “potentially other Generic Defendants,” see, e.g., Am. Compl. ¶ 4(c), or a list of several generic defendants separated by the language “and/or,” see id. ¶ 1(c). For the first plaintiff Streed, the Amended Complaint spells out the names of all of the defendants, including Sandoz and Eon, as responsible for the amiodarone he ingested, but it does not explain which defendant, if any, engaged in any activity within California connected to Mr. Streed’s claims or how that activity is actually connected to California. Am. Compl. ¶ 1(c). Finally, this Court’s jurisdiction over this case and its fifty-six non-California resident Plaintiffs and exclusively out-of-court manufacturer-defendants would not comport with well- established notions of “fair play and substantial justice.” Factors to consider include: (1) the burden on the defendant(s); (2) the forum state’s interest in adjudicating the dispute; (3) plaintiffs’ interests in obtaining convenient and effective relief; (4) the court’s interest in obtaining the most efficient not arise out of the defendant's forum contacts, is currently on appeal before the U.S. Supreme Court. See Bristol-Myers Squibb Co. v. Super. Ct., 1 Cal. 5th 783, 788 (2016), cert. granted sub nom. Bristol-Myers Squibb Co. v. Super. Ct. of Cal., San Francisco Cnty., 137 S. Ct. 827 (2017). The Bristol-Myers Squibb Co. decision in California is not binding on this court and is inconsistent with prior U.S. Supreme Court precedent. Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 18 of 33 11 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 resolution of controversies; and (5) the shared interest of the several states in furthering fundamental substantive social policies. Burger King Corp. v. Rudzewicz, 471 U.S. 462, 477 (1985). All of the factors weigh heavily against a fair exercise of specific jurisdiction here. First, Sandoz and Eon are not headquartered in California, nor do they operate any facilities or have any employees working in California specifically with amiodarone. Sandoz’ amiodarone products are manufactured in North Carolina, sold from New Jersey, and distributed from Pennsylvania. Thus, it would be burdensome for Sandoz and Eon to defend this action in California and inefficient for all parties to maintain a venue so far from the location of the majority of witnesses, including the vast majority of the Plaintiffs themselves. Second, Plaintiffs have not pled sufficient facts suggesting any legitimate concern of the forum state California with adjudicating the claims of the California Plaintiffs, and California has no interest in adjudicating disputes between non-Californians against other non-Californians, which is the majority of claims at issue. Nor is there any reason to believe this Court would find this matter more efficient to resolve in California given that most of the Plaintiffs are not state residents, and no shared interests of multiple states are asserted. As such, this matter should be dismissed for lack of both general and specific jurisdiction as to Sandoz and Eon.7 II. PLAINTIFFS FAIL TO STATE A CLAIM FOR FAILURE TO PROVIDE MEDICATION GUIDES AGAINST SANDOZ AND EON BECAUSE THEY DO NOT ALLEGE A BREACH OF ANY COGNIZABLE DUTY OWED TO THE PLAINTIFFS. The main crux of Plaintiffs’ claims is an allegation that they “did not receive the required Medication Guide for the [Amiodarone] prescriptions” they filled at the time of receiving such prescriptions from their dispensing pharmacies. Even if factually true, Plaintiffs misread the requirements of federal law incumbent upon manufacturers such as Sandoz and Eon, and fail to state a claim under state law because the learned intermediary doctrine only requires manufacturers to warn “learned intermediaries” -- physicians and pharmacists -- of the risks of a prescription drug 7 Because of the lack of relation to California, this matter should be dismissed for lack of personal jurisdiction rather than transferred to a different forum. Pursuant to 28 U.S.C. §1631 a court may, in the interest of justice, transfer a case to another court in which the action could have been brought at the time it was filed. See Chavez, 836 F.3d 205, 224 (3rd Cir. 2016). However, Defendants incorporate the Motion to Sever in which they requested that this Court sever each individual plaintiff’s claims into separate actions and require re-pleading of the specific defendants whose products they allegedly ingested, in an appropriate forum for each plaintiff rather than combining all actions into one case in California. Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 19 of 33 12 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 product and imposes no duty to deliver warnings directly to patients. Carlin v. Super. Ct. of Sutter Cnty., 13 Cal. 4th 1104, 1118 (1996) (establishing learned intermediary doctrine in California). Medication Guides are a creature of federal law and FDA regulations, under which Sandoz and Eon’s obligations are clear. The FDA, in its role as the sole regulator and enforcer for the prescription drug industry, has established rules for drug manufacturers requiring them to either distribute or make Medication Guides available only to “authorized dispensers” (pharmacies), but the FDA does not require manufacturers to distribute Medication Guides to the patient level. 21 C.F.R. §208.24. These rules prudently reflect the reality of the prescription drug industry, in which patients and manufacturers are separated by pharmacists and prescribing physicians. See id. Specifically, FDA’s Medication Guide regulation states that: (b) Each manufacturer who ships a container of drug product for which a Medication Guide is required under this part is responsible for ensuring that Medication Guides are available for distribution to patients by either: (1) Providing Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription for the drug product; or (2) Providing the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription for the drug product. . . . (e) Each authorized dispenser of a prescription drug product for which a Medication Guide is required under this part shall, when the product is dispensed to a patient (or to a patient’s agent), provide a Medication Guide directly to each patient (or to the patient’s agent) . . . Id. (emphasis added). An “authorized dispenser” is “an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice,” not a drug manufacturer like Sandoz or Eon. Id. Because Sandoz and Eon are not “authorized dispenser[s],” as the Amended Complaint concedes (Am. Comp. ¶ 80), they are thus not required to either deliver Medication Guides directly or make them available to patients. Nor are manufacturers like Sandoz and Eon legally obligated to ensure patients otherwise received Medication Guides with their prescriptions, which would be an impossible obligation given that the Medication Guides leave the manufacturer’s control and may pass through several additional entities within the supply chain before a pharmacist ultimately Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 20 of 33 13 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 dispenses the drug product to a patient. Plaintiffs here attempt to penalize defendants for not ensuring that Medication Guides made their way through each step of this journey and are ultimately given out by individual pharmacists with individual prescriptions, but the plain language of the regulation cannot plausibly be read to even suggest such a duty on drug manufacturers to ensure the travel of Medication Guides all the way down to end users. See 21 C.F.R. §208.24. Having dispensed with any possibility that federal law imposes such a duty with respect to Medication Guides on Sandoz or Eon, Plaintiffs cannot instead pin their hopes on the existence of such an extensive duty under state law. In California, the learned intermediary doctrine governs the duty of prescription drug manufacturers to provide warnings about the risks presented by prescription drug products. Carlin, 13 Cal. 4th at 1118. Consistent with this doctrine, California Supreme Court held that under state law, “the duty to warn runs to the physician, not to the patient.” Id. (emphasis in original). In the case of medical prescription drugs, “if adequate warning of potential dangers of a drug has been given to doctors, there is no duty by the drug manufacturer to insure that the warning reaches the doctor’s patient for whom the drug is prescribed.” Id. California federal courts rely on the same doctrine, finding a manufacturer discharges its duty to warn if it provides adequate warnings to the physician about any known or reasonably knowable dangerous side effects, regardless of whether the warning reaches the patient. Motus v. Pfizer Inc., 196 F.Supp.2d 984, 990-91 (C.D. Cal. 2001); see also Thomas v. Abbott Labs., No. CV12-07005-MWF, 2014 WL 4197494 (C.D. Cal. 2014). Accordingly, Defendants discharged their duty to provide warnings by making the labeling, including the Medication Guide, available to prescribing physicians and pharmacists. Plaintiffs cannot ground any cause of action for failure to provide Medication Guides on federal or state law, and such claims should be dismissed as legally unsound. III. ALL OF PLAINTIFFS’ CLAIMS ARE PREEMPTED BY FEDERAL LAW AND SHOULD THEREFORE BE DISMISSED. Not only do Plaintiffs’ Medication Guide claims lack legal support, but they, along with all of Plaintiffs’ other causes of action, are also impliedly preempted by federal law and must be dismissed. Plaintiffs’ claims against Defendants are all ultimately premised on failure-to-warn allegations, which the U.S. Supreme Court held in Mensing are preempted. See Mensing, 564 U.S. at 624-25. Dozens of Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 21 of 33 14 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 District Courts and Circuit Courts of Appeals have recognized that Mensing broadly preempts nearly all claims against generic drug manufacturers that in any way attack the warnings, representations or disclosures a manufacturer makes about a generic drug’s risks. Further, Plaintiffs’ off-label promotion and Medication Guide claims also exist solely by virtue of federal statutes and regulations and thus are also impliedly preempted under 21 U.S.C. §337(a)’s prohibition on private enforcement of the FDCA and its regulations, as recognized by the U.S. Supreme Court in Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). Numerous other courts to consider the potential preemption of claims just like those pled in the instant case, involving the same drug at issue here, have held such claims to be preempted, and this Court should reach the same conclusion. See, e.g., Rusk, 2015 U.S. Dist. LEXIS 179113 (dismissing products liability claims as “preempted as a matter of law”); Perdue, 209 F. Supp. 3d 847 (E.D. N.C. 2016) (dismissing medication guide and off-label promotion claims as preempted); Elliott, 2016 WL 4398407, at *9 (dismissing failure-to-warn and medication guide claims as preempted); McLeod, 2017 WL 1196801, at *7 (dismissing medication guide and products liability claims as preempted); Tutwiler, slip op., Exhibit C (dismissing medication guide claims as inconsistent with learned intermediary doctrine and preempted). Because the preemption challenge here presents a pure legal issue, it is appropriate for the Court to decide it at the pleading stage, as other courts have done when faced with similar arguments. See Mensing, 564 U.S. 604 (2011). A. Plaintiffs’ Claims Are All Preempted Failure-to-Warn Claims. Plaintiffs generally allege Defendants’ amiodarone was and is “defective due to inadequate post-marketing warning and instruction.” (Am. Compl. ¶ 125). These allegations necessarily contend Defendants’ labeling should have contained different or additional warnings-precisely the type of claim preempted by Mensing, 564 U.S. at 616-24. In 2011, the Supreme Court determined all state law tort claims attacking the sufficiency of warnings provided by generic manufacturers about ANDA-approved drugs are preempted by federal law. The consolidated lawsuits at issue in Mensing “involve[d] state tort-law claims based on certain drug manufacturers’ alleged failure to provide adequate warning labels for generic metoclopramide.” Id. at 608-09. Faced with the question of “whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 22 of 33 15 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 thus pre-empt, these state-law claims,” the Supreme Court held that they do. Id. at 609. The majority opinion recognized the dispositive impact on all product liability suits against generic manufacturers, holding “because pharmacists, acting in full accord with state law, substituted generic metoclopramide [for the branded product] . . . federal law pre-empts these lawsuits.” Id. at 625 (emphasis added). The dissenting justices also emphasized the impact on suits against generic manufacturers, stating “[i]f [a consumer] takes a generic drug, as occurs 75 percent of the time, she now has no right to sue.” Id. at 643 (Sotomayor, J., dissenting.) (emphasis added). The overwhelming majority of state and federal courts, including the Ninth Circuit in Moretti v. Wyeth, 579 F. App’x 563 (9th Cir. 2014), have recognized the plain impact of Mensing: no state law tort claims attacking a generic drug’s warnings, representations, disclosures, or other marketing can survive federal preemption.8 The Supreme Court reaffirmed and expanded Mensing in Bartlett, recognizing preemption applies to design defect claims or claims alleging a duty to withdraw a product from the market. Since Bartlett, more than 100 federal and state courts have dismissed virtually all products liability and tort claims against generic manufacturers as preempted. Indeed, numerous district courts have granted motions to dismiss failure-to-warn claims in cases involving the exact same product-generic amiodarone-when presented with very similar allegations. See Rusk, 2015 U.S. Dist. LEXIS 179113 (granted in part); Stephens, at 1254 (dismissing all claims with prejudice); Perdue, 209 F. Supp. at 851 (dismissing all claims with prejudice); Elliott, at *9 (granted in part); McLeod, at *7 (dismissing medication guide and products liability claims as preempted); Tutwiler, Exhibit C (dismissing medication guide claims as inconsistent with learned intermediary doctrine and preempted). In Rusk, the court addressed nearly identical claims regarding amiodarone, and the Court found all of Plaintiffs’ failure-to-warn claims preempted as a matter of law.9 Likewise, in Stephens, the court held under Mensing that failure-to-warn claims are “wholly 8 See, e.g., Guarino v. Wyeth, 719 F.3d 1245 (11th Cir. 2013) (state warning claims are preempted); Johnson v. Teva Pharm. USA, Inc., 758 F.3d 605 (5th Cir. 2014) (affirming dismissal of failure to warn, design defect, and “stop-selling” as preempted); In re Darvocet, Darvon & Propoxyphene Products Liab. Litig., 756 F.3d 917 (6th Cir. 2014) (affirming dismissal of all claims); Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674 (5th Cir. 2014) (same); In re Fosamax Products Liab. Litig., 751 F.3d 150 (3rd Cir. 2014) (same); Lashley & Del Valle v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014). (affirming all claims dismissed as preempted); Drager v. PLIVA USA, Inc., 741 F.3d 470 (4th Cir. 2014) (same); Moretti v. Mutual Pharm. Co., 518 Fed. App’x 486 (8th Cir. 2013) (affirming dismissal of warning claims as preempted). 9 See October 26, 2015 Order in Rusk v. Sandoz Inc., attached as Exhibit D; June 11, 2015, Report and Recommendation in Rusk v. Sandoz Inc., attached as Exhibit E. Sandoz filed a second Motion to Dismiss the Amended Complaint in Rusk Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 23 of 33 16 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 preempted by federal law,” and plaintiffs could not “sue a generic manufacturer on a failure to warn claim or a state law design defect claim that turns on the adequacy of a drug’s warnings.” Stephens, 70 F. Supp. 3d at 1250. Most recently, in Elliott, the court cited Mensing to dismiss the same failure- to-warn claims asserted here relating to generic amiodarone. 2016 WL 4398407, at *5-6. B. Plaintiffs’ Off-Label Promotion and Medication Guide Claims Are Also Impliedly Preempted and Subject to Dismissal. Separate and apart from Mensing preemption, Plaintiffs’ claims are also impliedly preempted by 21 U.S.C. §337(a) because they are premised upon violations of federal duties that only the federal government may enforce. See Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001). In Buckman, the Supreme Court cited 21 U.S.C. § 337(a) to hold “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized to file suit for noncompliance with the [law].” Id. Where “the existence of these federal enactments is a critical element in [plaintiff’s] case,” and where a plaintiff’s claims “exist solely by virtue of the FDCA . . . requirements,” state law claims are impliedly preempted by the FDCA. Id. at 352. While Plaintiffs plead both off-label promotion and failure to provide Medication Guide allegations against Sandoz and Eon, both theories of liability are ultimately dependent upon and exist solely by virtue of the FDCA’s restrictions on Sandoz and Eon as manufacturers, and thus are impliedly preempted. Plaintiffs specifically base their off-label promotion claims10 on Defendants’ alleged violation of portions of the Food, Drug and Cosmetic Act that make it “unlawful for a manufacturer to promote any drug for a use not described in the approved labeling of the drug.” 21 U.S.C. §§ 331(d), 352(f), and 355. California law does not contain similar restrictions on off-label promotion, and Plaintiffs’ off-label promotion allegations and assertions of unlawfulness of such promotion make clear they premise these claims upon violations of federal statutes. Thus, because Plaintiffs’ off-label promotion claims are based solely on alleged violations of the FDCA and its regulations, these claims are and the court then dismissed the off-label marketing claims with prejudice as inadequately pled. See September 7, 2016 Order on Report and Recommendation in Rusk v. Sandoz Inc., attached as Exhibit F. 10 For example, Plaintiffs’ Fourth Cause of Action for “Negligence Per Se,” Am. Compl. ¶¶ 169-175, is premised on a violation of the Sherman Food, Drug and Cosmetic Act, Cal. Health & Safety Code § 111225, but plaintiffs cannot use state laws mirroring the FDCA to pled around 21 U.S.C. § 337(a). See Dunbar v. Medtronic, Inc., No. CV 14-01529- RGK AJWX, 2014 WL 3056026, at *6 (C.D. Cal. June 25, 2014). Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 24 of 33 17 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 impliedly preempted under Buckman and 21 U.S.C. §337(a). See, e.g., Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1177 (C.D. Cal. 2013) (holding “any negligence claim based solely on illegal off-label promotion is impliedly preempted under Buckman and § 337(a)”); Perdue, 209 F. Supp. at 852 (“The restrictions and guidelines placed upon pharmaceutical companies for off-label promotion are entirely dependent upon the statutory and regulatory scheme created by the FDCA, which balances recognized benefits of off-label use with potential harms associated with promotion of such use,” and thus such claims are impliedly preempted.). Similarly, even if it were not clear on its face that federal law does not require manufacturers to ensure delivery of Medication Guides all the way to the end user, any duty on the part of manufacturers to distribute or make Medication Guides available to authorized dispensers under 21 C.F.R. §208.24(b) is created solely by federal law, and no private right of action exists under state law to permit Plaintiffs to pursue violations of this exclusively federal duty. See 21 U.S.C. §337(a). “The duty of the Defendant to provide Medication Guides to pharmacies (i.e., ‘distributors, packers or authorized dispensers’) arises solely under federal law,” and thus Buckman preemption applies. Elliott, supra, 2016 WL 4398407, at *6 (emphasis in original). Plaintiffs have no right to privately enforce the regulations requiring manufacturers to distribute or make available Medication Guides, and claims premised upon alleged failure to comply with federal regulations governing Medication Guides should be dismissed as impliedly preempted. See id. In Perdue, a very similar case filed by the same plaintiffs’ counsel and also involving amiodarone, the Eastern District Court of North Carolina dismissed both off-label promotion and failure to provide Medication Guide claims as impliedly preempted pursuant to Buckman and 21 U.S.C. §337(a). Perdue, at 851-53. Perdue first recognized that traditional products liability claims- similar to those alleged in the instant Amended Complaint-against generic manufacturers of amiodarone are preempted by Mensing and Bartlett, and also opined that off-label promotion and Medication Guide claims are premised upon federal duties that only the federal government has the right to enforce. Id. at 850. Applying Buckman, the Perdue court recognized this lack of a private right of action is fatal to both off-label promotion claims and claims based on failure to provide a Medication Guide, both of which necessarily depend on purported violations of exclusively federal Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 25 of 33 18 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 duties. Id. at *852-853. Thus, the Perdue Court dismissed both claims as preempted. Id.; see also Elliott v. Sandoz Inc., supra, 2016 WL 4398407, at *10 (Recognizing that “[t]he duty of Defendant to provide Medication Guides to pharmacies (i.e., ‘distributors, packers, or authorized dispensers’) arises solely under federal law” and thus preemption applies); McDaniel v. Upsher-Smith Pharmaceuticals, Inc., No. 2:16-cv-02604, 2017 WL 657778, at *4 (W.D. Tenn. Jan. 26, 2017) (dismissing with prejudice Medication Guide claims against an amiodarone manufacturer that arose solely from federal law and “would not exist ‘in the absence of the FDCA’”). Just as these and numerous other courts have found claims just like those pled here to assert violations of exclusively federal duties that only the federal government may enforce, this Court should dismiss these claims as preempted. C. The Ninth Circuit and Northern District of California Have Dismissed Numerous Claims Like These Against Generic Manufacturers as Preempted. The Ninth Circuit and the Northern District Court of California have granted motions to dismiss in other cases involving generic medication with very similar if not identical allegations and claims as those in this case, finding these claims to be preempted. See Ko v. Mutual Pharm. Co., Inc., No. C13-00890-RMW, 2013 WL 5692375, *2 (N.D. Cal. Oct. 18, 2013) (strict liability, negligence, and unfair competition claims were “based on a failure-to-warn theory and consequently preempted.”). The leading Ninth Circuit case is Moretti v. Wyeth, 579 F. App’x 563 (9th Cir. 2014), in which a customer brought suit against generic and brand name manufacturers of Reglan/metoclopramide, alleging the label accompanying the product was false, misleading, and inadequate. The district court dismissed claims against the generic manufacturer, holding that “[a]pplying Mensing, Plaintiffs’ claims are preempted and must be dismissed.” Moretti v. PLIVA, Inc., No. 2:08-cv-0396, 2012 WL 628502, at *5 (D. Nev. 2012). The Ninth Circuit agreed, explaining Mensing made clear “tort claims based on a generic manufacturer’s failure to unilaterally strengthen warning claims are preempted by the federal requirement that generic labels display exactly the same information as the federally approved brand-name label[.]” Moretti, 579 F. App’x at 565. This holding precludes any claims attacking the warnings provided by Sandoz, Eon and the other generic manufacturers regarding the risks presented by their ANDA-approved amiodarone products. Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 26 of 33 19 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 Similarly, in Ko, the court considered similar products liability claims brought by a plaintiff who alleged that a generic anti-inflammatory medication caused her personal injuries. Ko, 2013 WL 5692375. The generic manufacturer moved to dismiss on preemption grounds. Ko, 2013 WL 5692375 at *1. The court agreed, finding strict liability, negligence, and unfair competition claims were “all based on a failure-to-warn theory and consequently preempted by federal law.” Id. at *2. The court explained that, “Because generic drug manufacturers are required by federal law to use the same FDA approved labeling as the manufacturers of the brand-name drug, and because generic manufacturers cannot legally change their labels to even add additional warnings, any state law claims based on failure-to-warn would conflict impermissibly with federal FDA regulations, and are therefore preempted.” Id. at *2 (citing PLIVA v. Mensing, 564 U.S. at 604-05).11 In addition, numerous California district courts have held that off-label promotion claims, in the analogous context of FDA-regulated medical devices, are impliedly preempted under Buckman. See Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1178 (C.D. Cal. 2013) (“any negligence claim based solely on illegal off-label promotion is impliedly preempted under Buckman and § 337(a)”); Dunbar v. Medtronic, Inc., No. CV 14-01529-RGK, 2014 WL 3056026, at *5 (C.D. Cal. June 25, 2014) (“[T]here is no claim for illegal off-label promotion rooted in traditional state tort law. Therefore, any common law claim arising from such an action exists only by virtue of the FDCA. Permitting this claim to proceed would essentially allow a private litigant to attempt enforcement of the FDCA. Buckman bars such an action under § 337(a). Therefore, Plaintiffs’ negligence claim based on off-label promotion is impliedly preempted.”); Anderson v. Medtronic, Inc., No. 14-CV- 00615-BAS, 2015 WL 2115342, at *6 (S.D. Cal. May 6, 2015) (“There is no state law claim for negligence based on off-label promotion. In fact, there would be no such thing as off-label promotion without the federal statutory scheme. In other words, Plaintiffs allege Defendants are negligent because they violate the federal statutory scheme by promoting off-label use. Such a claim is impliedly preempted under Buckman.”). 11 See also In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., No. 05-1699 CRB, 2006 WL 2374742, at *10 (N.D. Cal. Aug. 16, 2006) (“[P]laintiffs’ claims premised on Pfizer’s failure to warn consumers and physicians . . . are dismissed as preempted”); Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC, 2014 WL 819392, at *3 (C.D. Cal. Feb. 14, 2014) (failure to warn claims preempted); Frere v. Medtronic, Inc., No. 15-2338, 2016 WL 1533524, at *8 (C.D. Cal. Apr. 6, 2016) (same); Houston v. Medtronic, Inc., 957 F.Supp.2d 1166, 1177 (C.D. Cal. 2013) (same). Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 27 of 33 20 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 IV. PLAINTIFFS’ CLAIMS ARE INSUFFICIENTLY PLED. Plaintiffs’ claims are not only preempted but are inadequately pled under Fed. R. Civ. P. 8(a)(2) and 9(b). A complaint must contain a “plain statement of the claim showing that the pleader is entitled to relief, in order to ‘give the defendant fair notice of what the . . . claim is and the grounds upon which it rests.” Twombly, 550 U.S. at 554 (internal quotation omitted). Dismissal is warranted if a complaint merely contains “naked assertions devoid of further factual enhancement,” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009), or “a formulaic recitation of the elements of a cause of action.” Twombly, 550 U.S. at 555. The Amended Complaint contains only conclusory allegations and legal recitations devoid of any factual support, which do not rise to the level of plausibility and thus are insufficiently pled. For example, for all but a handful of Plaintiffs, the Amended Complaint does not even specify which manufacturers’ amiodarone products the patient actually took, thus failing to plead even the minimal element of product identification that serves as the basis for a claim for relief against such defendant. Plaintiffs do not specify the dates on which particular prescriptions provided to each plaintiff or decedent, the pharmacies at which they were filled, or other minimal detail for their claims that warnings were not provided with prescriptions. This is inadequate under Rule 8 and these claims may be dismissed for this reason. A. Plaintiffs Have Not Pled Their Off-Label Promotion Claims with the Particularity Required by FED. R. CIV. P. 9(b). In addition to the overall inadequacies of Plaintiffs’ pleading, the Amended Complaint alleges fraud, deceit, misrepresentation and fraudulent off-label promotion of amiodarone, all of which fall under the heightened pleading with particularity requirements of Fed. R. Civ. P. 9(b) for fraud-based claims. Despite pleading specific allegations as to other defendants regarding decades-old allegations of off-label promotion, Plaintiffs’ claims against Defendants utterly lack any specifics about purported fraudulent conduct or representations, such as dates, names, or any specific statements made by Defendants or their employees or agents, and instead plead only in blanket fashion that all of the Generic defendants undertook to promote off-label uses of amiodarone and also benefitted from Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 28 of 33 21 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 previous off-label promotional conduct by Wyeth.12 This plainly falls well short of the particularity Rule 9(b) requires as to the “who, what, when, and where” of fraud-based claims. Plaintiffs’ fraud-based allegations can be summed up as either intentional omissions or misrepresentations of the efficacy or risks of amiodarone. For example, Plaintiffs allege Defendants “concealed [] adverse event information, []simultaneously engaged in a massive and illegal marketing and promotional scheme in which they aggressively and illegally promoted [] amiodarone for uses never authorized by the FDA;” “Defendants continued their fraudulent marketing, promotional, and sales practices [] through the present date”; and “Defendants’ [] deception, concealment, and illegal marketing and promotion [] has been so pervasive throughout the United States.” Am. Compl. ¶¶ 120, 126, 130. Yet, Plaintiffs do not provide a single specific statement made by either Sandoz or Eon to any plaintiff or their prescribing physician. In fact, not a single specific instance of a fraudulent or false representation by Sandoz or Eon is contained within the 149-page Amended Complaint. Rule 9(b) requires a party to “state with particularity the circumstances constituting fraud or mistake.” To state a claim of fraud with sufficient particularity pursuant to Rule 9(b), requires “pleading facts which show how, when, where, to whom, and by what means the representations were tendered.” Stansfield v. Starkey, 220 Cal.App.3d 59, 73 (1990).13 Further, every element of a fraud cause of action must be alleged both factually and specifically. Cooper v. Equity General Ins., 219 Cal.App.3d 1252, 1262 (1990). When read together, Rules 9(b) and 12(b)(6) require a plaintiff to specifically allege each element of a fraud claim in order to survive a motion to dismiss. Here, Plaintiffs’ vague blanket assertions do not specify any conduct, let alone fraudulent conduct, undertaken by Defendants. Even if such an allegation were pled, Plaintiffs also do not attempt to identify the declarant, time, place or context of any fraudulent representations or omissions by Sandoz or Eon. These fraud-based allegations are nothing more than conclusory statements, 12 Plaintiffs’ off-label promotion allegation is contradicted by the widely recognized differences between promotional activities undertaken by brand manufacturers, who employ sales representatives marketing directly to physicians, and generic manufacturers like Defendants who negotiate contracts with customers, including distributors and pharmacies, on the basis of price and ability to provide consistent supply. Defendants could not have promoted amiodarone to physicians or consumers for off-label uses, because Defendants do not promote amiodarone to physicians or consumers at all. 13 California law also requires that in actions for fraud, a claimant is required to prove each and every element: “(a) misrepresentation (false representation, concealment, or nondisclosure); (b) knowledge of falsity (or ‘scienter’); (c) intent to defraud, i.e., to induce reliance; (d) justifiable reliance; and (e) resulting damage.” Lazar v. Super. Ct., 12 Cal. 4th 631, 638 (1996). Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 29 of 33 22 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 unsupported by facts, and entirely devoid of the requisite “particularity [of] the circumstances constituting fraud.” Fed. R. Civ. P. 9(b). As in Stansfield, Plaintiffs’ claims fail to “show how, when, where, to whom, and by what means the representations were tendered.” Federal courts in other amiodarone cases have dismissed claims for failure to plead with specificity. In Dreher v. Wyeth Pharm., Inc., No. 2:14-CV-00280, 2015 WL 3948961, at *6 (N.D. Ala. June 29, 2015), the court found Plaintiffs’ complaint deficient under Rule 8 for failing to “assert any factual allegations in support of his claims against the Generic Defendants for the off-label promotion of amiodarone.” The Dreher court explained that the plaintiff offered no facts to support his allegations, and, thus, “his allegations are quintessential examples of the ‘naked assertion[s] devoid of further factual enhancement’ that the Supreme Court declared to be insufficient to survive a motion to dismiss.” Dreher, 2015 WL 3948961, at *6 (citing Iqbal, 556 U.S. at 678). See also Elliott, 2016 WL 4398407 (dismissing similar off-label promotion claims as inadequately pled); McLeod, 2017 WL 1196801 (same); Tutwiler, Exhibit C (same). This Court should reach the same result here, because just as in these other amiodarone cases filed by the same plaintiffs’ counsel, there are no specific factual allegations of fraudulent or misleading conduct or promotional activities undertaken by Sandoz or Eon, and these claims may not proceed past the pleading stage absent these specifics. B. Plaintiffs Improperly Base Their Off-Label Promotion Claims on Conduct Allegedly Undertaken by Entities Other than Defendants. The Amended Complaint also premises its off-label promotion claims against Sandoz and Eon on the alleged conduct of brand manufacturer Wyeth and then levies generalized, conclusory claims of off-label promotion against Defendants as a supposedly willing beneficiary of Wyeth’s conduct (which Defendants deny). Am. Compl. ¶¶ 1-39, sub.(d). (“The Generic Defendants took advantage of Wyeth’s aggressive marketing plan positioning Amiodarone as a ‘first line anti- arrhythmic’ described above, and directly benefited from the decades of marketing of the drug for ‘off-label’ uses by Defendant Wyeth”, and “Defendants actively concealed such facts and instead actively promoted or piggy-backed the promotional efforts of innovator brand drug manufacturer Wyeth, for ‘off-label,’ unapproved uses….”). The Amended Complaint alleges “Wyeth aggressively and successfully marketed Cordarone® for inappropriate ‘off-label’ uses as a ‘first line anti- Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 30 of 33 23 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 arrhythmic therapy.’” Am. Compl. ¶¶ 67, 71, 116. Regardless of whether these minimal allegations regarding often decades-old purported conduct are enough to state a claim against Wyeth, they are patently insufficient to state a plausible claim against Defendants. Plaintiffs’ off-label promotion allegations allege, at most, that Defendants benefitted from earlier conduct by another manufacturer with whom they are not affiliated and are in fact competitors. These allegations cannot serve as the basis for a fraud-based claim against Defendants, absent specific allegations of off-label promotion by Defendants that influenced the prescribing decisions a plaintiff’s physician. V. PLAINTIFFS’ CLAIMS ARE BARRED BY THE STATUTE OF LIMITATIONS. Thirteen named Plaintiffs cannot proceed in this action because their claims are barred by the applicable statutes of limitations on their face. Dismissal under Rule 12(b)(6) is appropriate when a plaintiff’s complaint makes clear his claims are barred by the applicable statute of limitations. See Lukovsky v. City & Cnty. of S.F., 535 F.3d 1044, 1052 (9th Cir. 2008) (upholding dismissal pursuant to Rule 12(b)(6) on statute of limitations grounds.).14 Plaintiffs’ claims are foreclosed by their own allegations in the Amended Complaint - in particular they all provide a date for onset of the alleged symptoms attributed to amiodarone use, stating they “began to experience many of the symptoms outlined in the Medication Guide.” Am. Compl., ¶¶ 5(g), 25(g), 34(g). At symptom onset, these Plaintiffs were on notice of a potential link between amiodarone and their alleged symptoms. In some cases, Plaintiffs even provide a date when they were diagnosed with “amiodarone-induced” toxicity or conditions. See, e.g., ¶¶ 16(g), 27(g). Nowhere in the Amended Complaint do these Plaintiffs recount extraordinary circumstances that precluded them from filing a lawsuit after experiencing the alleged symptoms, nor do they allege any behavior by Defendants that precluded or hampered their ability to do so. The moment these plaintiffs had suspicion of any amiodarone-induced symptoms, they were on notice of a purported connection between amiodarone and their conditions. At that point 14 The limitations period commences when the cause of action accrues-i.e., when the “‘cause of action is complete with all of its elements.’” Fox v. Ethicon Endo-Surgery, Inc., 35 Cal. 4th 797, 806-807 (2005). A cause of action has accrued when, “under the substantive law, the [alleged] wrongful act is done,” or the “wrongful result occurs, and the consequent ‘liability arises.’” Norgart v. Upjohn Co., 21 Cal. 4th 383, 397 (1999). Accordingly, the limitations period begins to run “when a suit may be maintained,” and when the alleged injuries have been suffered. Howard Jarvis Taxpayers Ass’n v. City of La Habra, 25 Cal. 4th 809, 815 (2001) (quoting Cnty. of San Diego v. Myers, 147 Cal. App. 3d 417, 421 (1983)). Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 31 of 33 24 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 their causes of action accrued, and the statute of limitations commenced. Thus, because their date of discovery falls outside their respective states’15 statutes of limitations, these claims are time-barred. Attached as Exhibit G is a chart listing the dates on which each Plaintiff’s cause of action accrued, and the governing statute of limitations. A summary follows:  Alabama: Plaintiffs Cobb, Duncan, and Rhodes’ product liability, negligence, and fraud claims barred by 2 year statute of limitations. Ala. Stat. §6-2-38. (FAC ¶¶ 4(g), 34(g), 5(g)).  California: Plaintiff Medford’s product liability, negligence, and fraud claims barred by 2 year statute of limitations. Cal. Code Civ. Proc. §§335.1, 340.8(a). (FAC ¶ 16(g)).  Georgia: Plaintiffs Ackerman and Bussell’s product liability, negligence, fraud claims barred by 2 year statute of limitations. O.C.G.A. §9-3-33. (FAC ¶¶ 25(g), 29(g)).  Kentucky: Plaintiff Coontz’ product liability, negligence, and fraud claims barred by 1 year statute of limitations. Ky. Rev. Stat. §413.140(1)(a). (FAC ¶¶ 23(g), 21(g)).  Michigan: Plaintiff Bivins’ product liability, negligence, and fraud claims barred by 3 year statute of limitations. MCLA §600.5805(13). (FAC ¶ 7(g)).  North Carolina: Plaintiff Jenkins’ product liability, negligence, and fraud claims barred by 3 year statute of limitations. N.C.G.S.A. §1-52(16), N.C.G.S.A. §1-52(1)-(5). (FAC ¶ 30(g)).  Ohio: Plaintiff Murphy’s product liability, negligence, and fraud claims barred by 2 year statute of limitations. Ohio Rev. Code Ann. § 2305.10(A). (FAC ¶ 17(g)).  South Carolina: Plaintiff Ayers’ product liability, negligence, and fraud claims barred by 3 year statute of limitations. S.C. Code Ann. §§15-3-530, 15-3-535. (FAC ¶ 28(g)).  Tennessee: Plaintiff Burns’ product liability, negligence, and fraud claims barred by 1 year statute of limitations. Tenn. Code Ann. §28-3-104. (FAC ¶ 24 (g)).  Texas: Plaintiff Hart’s product liability, negligence, and fraud claims barred by 2 year statute of limitations. Tex. Civ. Prac. & Rem. Code Ann. §16.003. (FAC ¶ 9(g)).  California Unfair Competition Law and CLRA claims: Plaintiffs Bussell, Rhodes, Ayers, and Harts’ actions alleging fraud and deceit and violations of the CLRA are barred by 3 year statute of limitations under Cal. Civ. Proc. Code §§ 338(a), (c)(1), and (d); CLRA § 1783. See Am. Compl. ¶¶ 199-204. Minichino v. Wells Fargo Bank, N.A., No. C 11-01030 (SI), 2011 WL 4715153, at * 6 (N.D. Cal. Oct. 7, 2011) (applying 3 year statute of limitations to fraud and deceit claims); Plumlee v. Pfizer, Inc., No. 5:13-cv-00414-LHK, 2014 WL 4275519, at *6-7 (N.D. Cal. Aug 29, 2014) (applying CLRA’s 3 year statute of limitations). In addition, based on the date their claims accrued, the Unfair Competition Law claims brought by Plaintiffs Bussell, Jenkins, Ayers, Hart, Murphy, and Rhodes also are barred by the 4 year statute of limitations pursuant to Cal. Bus. & Prof. Code §§ 17200, 17208. All of these Plaintiffs’ claims are time-barred on their face based on their pleading of the relevant dates of ingestion, onset of symptoms, and accrual of their causes of action. 15 The California Supreme Court has made clear courts should apply the statute of limitations for jurisdictions where the alleged injury-producing conduct occurred. McCann v. Foster Wheeler LLC, 48 Cal. 4th 68, 97-98, 102 (2010). Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 32 of 33 25 SANDOZ INC. AND EON LABS, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS & AUTHORITIES Case No. 3:17-cv-02609-WHO 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 VI. PLAINTIFFS’ CLRA CLAIM IS NOT YET ACTIONABLE BECAUSE PLAINTIFFS FAILED TO COMPLY WITH MANDATORY PRE-SUIT NOTICE PROVISIONS. This Court is without jurisdiction to hear Plaintiffs monetary claims under the California Consumers Legal Remedies Act (“CLRA”) because Plaintiffs did not give requisite pre-suit notice. California Civil Code section 1782 states “no action for damages may be maintained under Section 1780 if an appropriate correction, repair, replacement, or other remedy is given, or agreed to be given within a reasonable time, to the consumer within 30 days after receipt of the notice.” No such notice was timely provided here prior to the filing of the Complaint. See Outboard Marine Corp. v. Superior Court, 52 Cal.App.3d 30, 41 (1975) (“The clear intent of the act is to provide and facilitate pre- complaint settlements of consumer actions wherever possible . . . This clear purpose may only be accomplished by a literal application of the notice provisions.”). Plaintiffs filed the original complaint (“Complaint”) on March 24, 2017, prior to sending a pre-suit notice letter detailing their CLRA demands, as required by Section 1780, even though Plaintiffs clearly pled CLRA claims in both their original and amended Complaints (see initial Complaint at ¶¶ 178-183; Amended Complaint at ¶¶ 199-204). The Amended Complaint, filed on May 1, 2017, purports to exclude monetary damages from the CLRA relief sought, but the Prayer for Relief requests general non-economic damages, special economic damages, prejudgment interest, and costs of suit. This claim thus violates the CLRA’s pre-filing notice provisions and this failure to provide the requisite pre-suit notice prior to assertion of such claims cannot be cured by amendment. CONCLUSION For the foregoing reasons, this Court should dismiss all of Plaintiffs’ claims under Fed. R. Civ. P. 12(b)(2) and 12(b)(6). The theories upon which Plaintiffs rely are invalid as a matter of law and amending the Amended Complaint will not cure the factual defects contained therein. Defendants therefore respectfully request that this Court dismiss Plaintiffs’ Amended Complaint with prejudice. DATED: May 22, 2017 GREENBERG TRAURIG, LLP By /s/ Greg Sperla Lori S. Cohen (admitted pro hac vice) Sara K. Thompson (admitted pro hac vice) Greg Sperla Attorneys for Defendants SANDOZ INC. and EON LABS, INC. Case 3:17-cv-02609-WHO Document 41 Filed 05/22/17 Page 33 of 33 EXHIBIT A Case 3:17-cv-02609-WHO Document 41-1 Filed 05/22/17 Page 1 of 3 Drugs@FDA: FDA Approved Drug Products https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=075315[5/18/2017 11:19:10 AM]  Home  Drug Databases  Drugs@FDA Drugs@FDA: FDA Approved Drug Products Home | Previous Page Abbreviated New Drug Application (ANDA): 075315 Company: SANDOZ Products on ANDA 075315 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET;ORAL Prescription Showing 1 to 2 of 2 entries Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075315 Therapeutic Equivalents for ANDA 075315  SHARE  TWEET  LINKEDIN  PIN IT  EMAIL  PRINT  EMAIL Other Important Information from FDA  CSV Excel Print Drug Name  Active Ingredients  Strength  Dosage Form/Route  Marketing Status   Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English Case 3:17-cv-02609-WHO Document 41-1 Filed 05/22/17 Page 2 of 3 Drugs@FDA: FDA Approved Drug Products https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=075315[5/18/2017 11:19:10 AM] Accessibility Careers FDA Basics FOIA No FEAR Act Site Map Nondiscrimination Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA       FDA Archive Combination Products  Advisory Committees  Regulatory Information  Safety  Emergency Preparedness  International Programs  News & Events  Training & Continuing Education  Inspections & Compliance  Federal, State & Local Officials  Consumers  Health Professionals  Science & Research  Industry  Case 3:17-cv-02609-WHO Document 41-1 Filed 05/22/17 Page 3 of 3 EXHIBIT B Case 3:17-cv-02609-WHO Document 41-2 Filed 05/22/17 Page 1 of 3 ANDA 75-315 December 23, 1998 Eon Labs Manufacturing, Inc. Attention: Sadie M. Ciganek 227-15 N. Conduit Avenue Laurelton, NY 11413 Dear Madam: This is in reference to your abbreviated new drug application dated January 6, 1998, submitted pursuant to Section 505(j) of the Federal Food, Drug, and Cosmetic Act, for Amiodarone Hydrochloride Tablets, 200 mg. Reference is also made to your amendments dated June 19, August 26, September 16, October 9, and November 13, 1998. We have completed the review of this abbreviated application and have concluded that the drug is safe and effective for use as recommended in the submitted labeling. Accordingly, the application is approved. The Division of Bioequivalence has determined your Amiodarone Hydrochloride Tablets, 200 mg to be bioequivalent and, therefore, therapeutically equivalent to the listed drug (Cordarone® brand of Amiodarone Hydrochloride Tablets, 200 mg of Wyeth Ayerst Laboratories, Inc.). Your dissolution testing should be incorporated into the stability and quality control program using the same method proposed in your application. Under 21 CFR 314.70, certain changes in the conditions described in this abbreviated application require an approved supplemental application before the change may be made. Post-marketing reporting requirements for this abbreviated application are set forth in 21 CFR 314.80-81 and 314.98. The Office of Generic Drugs should be advised of any change in the marketing status of this drug. We request that you submit, in duplicate, any proposed advertising or promotional copy which you intend to use in your initial advertising or promotional campaigns. Please submit all proposed materials in draft or mock-up form, not final print. Submit both copies together with a copy of the proposed or final printed labeling to the Division of Drug Marketing, Advertising, Case 3:17-cv-02609-WHO Document 41-2 Filed 05/22/17 Page 2 of 3 and Communications (HFD-40). Please do not use Form FD-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) for this initial submission. We call your attention to 21 CFR 314.81(b)(3) which requires that materials for any subsequent advertising or promotional campaign be submitted to our Division of Drug Marketing, Advertising, and Communications (HFD-40) with a completed Form FD-2253 at the time of their initial use. Validation of the regulatory methods has not been completed. It is the policy of the Office not to withhold approval until the validation is complete. We acknowledge your commitment to satisfactorily resolve any deficiencies which may be identified. Sincerely yours, Douglas L. Sporn Director Office of Generic Drugs Center for Drug Evaluation and Research Case 3:17-cv-02609-WHO Document 41-2 Filed 05/22/17 Page 3 of 3 EXHIBIT C Case 3:17-cv-02609-WHO Document 41-3 Filed 05/22/17 Page 1 of 15 Page 1 of 14 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ALABAMA SOUTHERN DIVISION Memorandum of Opinion and Order Plaintiff Barbara Tutwiler (“Plaintiff”) brought this products liability action against Defendant Sandoz Inc. (“Defendant”), alleging that a drug manufactured by Defendant caused her to suffer pulmonary injuries. Before this Court is Defendant’s Motion to Dismiss. (Doc. 6.) For the reasons stated more fully herein, Defendant’s motion is due to be granted. I. Background1 Plaintiff suffers from non-life-threatening atrial fibrillation, a relatively common heart condition for which her physician prescribed 200mg tablets of 1 In reviewing a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6), this Court treats the facts alleged in the complaint as true and construes them in the light most favorable to the non-moving party. Reese v. Ellis, Painter, Ratterree & Adams, LLP, 678 F.3d 1211, 1215 (11th Cir. 2012). The facts here are taken from Plaintiff’s complaint. (Doc. 1.) BARBARA R. TUTWILER, Plaintiff, vs. SANDOZ INC., Defendant. 2:16-cv-01246-LSC ) ) ) ) ) ) ) ) ) FILED 2017 Mar-09 PM 03:19 U.S. DISTRICT COURT N.D. OF ALABAMA Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 1 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 2 of 15 Page 2 of 14 amiodarone hydrochloride (“amiodarone”). Defendant manufactures a generic form of this drug, which was first approved by the federal Food and Drug Administration (“FDA”) in 1985 to be sold under the brand name Cordarone. Cordarone received “special needs” approval-that is, approval in the absence of data from rigorous clinical trials-from the FDA “as a drug of last resort” to treat “life-threatening ventricular fibrillation and ventricular tachycardia when these conditions would not respond to other available anti-arrhythmic drugs and therapies.” Plaintiff alleges that its manufacturer nonetheless marketed the drug to treat atrial fibrillation, without “warn[ing] prescribing physicians of the potential dangers associated with amiodarone toxicity” and the negative effects of the drug on atrial fibrillation patients. Such promotion of a drug for unapproved “off-label” uses is permissible only if the manufacturer complies with certain requirements set by the FDA. Beginning in 1988, Cordarone’s manufacturer received several letters from the FDA requesting that it cease the misleading marketing campaigns promoting Cordarone “as a first line anti-arrythmic therapy.” Generic manufacturers, such as Defendant, were able to manufacture and distribute amiodarone beginning in 1998. Federal law requires generic formulations of prescription drugs not only to be the bioequivalent of the name-brand drug but also to contain the same labels and warnings. Due to the special risks associated Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 2 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 3 of 15 Page 3 of 14 with amiodarone, federal law also requires manufacturers to provide Medication Guide literature to the pharmacy for distribution to the patient. According to Plaintiff, Defendant did not provide the Medication Guide to Plaintiff’s pharmacy, and the warnings used by Defendant did not properly explain the likelihood of adverse side effects, nor their “severity or duration.” As a result, the warnings did not alert physicians or consumers “of the actual risks associated with th[e] drug.” Plaintiff alleges that despite the fact that Defendant knew of accounts of amiodarone patients developing serious medical conditions, it did not report this information to the FDA, to healthcare professionals, or to consumers. Instead, according to Plaintiff, Defendant “took advantage of” the brand-name manufacturer’s previous promotional efforts and engaged in its own marketing campaign to tout the drug as a treatment for non-life-threatening atrial fibrillation. The combination of these promotional efforts misled physicians and caused them to prescribe amiodarone to patients with atrial fibrillation. Plaintiff used amiodarone from October 2012 until July 2014. She filled her prescriptions at her local pharmacy and ingested the drug as prescribed by her physician. Because she did not receive a Medication Guide from the pharmacy with each prescription, Plaintiff was unaware that amiodarone was not approved to treat atrial fibrillation and that she risked developing serious side effects from using the Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 3 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 4 of 15 Page 4 of 14 drug. Plaintiff ceased her use of amiodarone in July 2014, when she was diagnosed with interstitial lung disease and pulmonary fibrosis, which she alleges were caused by the drug. II. Standard of Review A pleading must, in general, present “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). In order to withstand a motion to dismiss, however, the complaint “must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Lord Abbett Mun. Income Fund, Inc. v. Tyson, 671 F.3d 1203, 1207 (11th Cir. 2012) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)). The plaintiff need not put forth “detailed factual allegations” in support of the claim, but there must be enough to “allow[] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678 (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556 (2007)). In evaluating the complaint, this Court must first “identif[y] pleadings that, because they are no more than conclusions, are not entitled to the assumption of truth.” Id. at 679. Next, this Court assumes the veracity of any well-pleaded factual allegations in order to “determine whether they plausibly give rise to an Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 4 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 5 of 15 Page 5 of 14 entitlement to relief.” Id. The plaintiff is not required “to specifically plead every element of his cause of action” against the defendant, but “a complaint must still contain enough information regarding the material elements of a cause of action to support recovery under some ‘viable legal theory.’” Am. Fed’n of Labor & Cong. of Indus. Orgs. v. City of Miami, 637 F.3d 1178, 1186 (11th Cir. 2011) (quoting Roe v. Aware Woman Ctr. for Choice, Inc., 253 F.3d 678, 683-84 (11th Cir. 2001)). Mere “labels and conclusions” in the absence of concrete factual allegations that “raise a right to relief above the speculative level” are insufficient to satisfy Rule 8(a)(2). Twombly, 550 U.S. at 555-56. III. Discussion Defendant contends that Plaintiff’s complaint is due to be dismissed because her claims are preempted by federal law or, alternatively, are insufficiently pled. Plaintiff’s claims may essentially be divided into claims alleging Defendant’s failure to warn and claims arising out of Defendant’s off-label promotion of amiodarone. Each is addressed in turn. A. Failure-to-Warn Claims First, Defendant argues that Plaintiff’s state-law failure-to-warn claims are preempted under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), which precludes Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 5 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 6 of 15 Page 6 of 14 state-law claims imposing a duty of care on prescription-drug manufacturers that exceeds federal labeling requirements. The plaintiffs in the consolidated cases in Mensing brought state tort claims against manufacturers of the generic drug metoclopramide, alleging that those manufacturers failed to modify the drug’s labels to adequately warn patients that long-term use of metoclopramide could lead to the development of tardive dyskinesia. Id. at 610. The manufacturers, in turn, contended that federal statutes and FDA regulations that “required [the manufacturers] to use the same safety and efficacy labeling as their brand-name counterparts” preempted the plaintiffs’ state-law claims, which held the manufacturers to a heightened duty to warn. Id. at 611-12. The Court agreed with the manufacturers, finding conflict preemption because any modification of the label to comply with state law violated federal laws with regard to the “duty of sameness.” Id. at 618. Plaintiff’s claims here are similarly preempted. In her failure-to-warn claims sounding in negligence and strict products liability, she alleges that the “warnings and directions” Defendant supplied with its amiodarone “failed adequately to warn of the potential risks and side effects” of using the medication as her doctor directed. She does not allege that these “warnings and directions” vary from the brand-name manufacturer’s labeling, and Mensing is clear that state law cannot Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 6 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 7 of 15 Page 7 of 14 impose labeling standards higher than the “duty of sameness” would require. Id.; Guarino v. Wyeth, LLC, 719 F.3d 1245, 1249 (11th Cir. 2013). To the extent that the failure-to-warn causes of action and the “personal injury” claim are based on the content of the “warnings and directions,” Plaintiff’s claims are preempted and are due to be dismissed. Plaintiff also alleges that she did not receive a Medication Guide with the prescription she filled at her pharmacy and thus was unaware of the dangers associated with using the drug for atrial fibrillation. According to Plaintiff, Defendant did not provide Medication Guides to the pharmacy for distribution to patients using its amiodarone. In Alabama, however, “a prescription-drug manufacturer fulfills its duty to warn users of the risk associated with its product by providing adequate warnings to the [physicians] who prescribe the drug.” Wyeth, Inc. v. Weeks, 159 So. 3d 649, 673 (Ala. 2014). Defendant thus has no independent duty to warn Plaintiff under Alabama law; its only obligation is to provide an adequate warning to her physician. See id. “[I]f the warning to the [physician] is inadequate or misrepresents the risk, the manufacturer remains liable for the injuries sustained by the patient [if] the manufacturer failed to warn the physician of a risk not otherwise known to the physician and that . . . failure to warn was the actual and proximate cause of the patient’s injury.” Id. Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 7 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 8 of 15 Page 8 of 14 However, to the extent that Plaintiff seeks to avoid the application of the learned-intermediary doctrine by implying that Defendant inadequately warned her physician of the risks of prescribing amiodarone to treat atrial fibrillation, such claims fail under Mensing. Plaintiff makes no allegation that the content of Defendant’s labels and warnings in any way differed from that of the labels and warnings used by the brand-name manufacturer, and state law cannot require more than compliance with the “duty of sameness.” See Mensing, 564 U.S. at 618. If the generic manufacturer’s warnings mirror those of the brand-name manufacturer, any claim against the generic manufacturer is preempted by federal law because only the brand-name manufacturer has the power “to unilaterally strengthen its warning without prior FDA approval.” Id. at 624 (quotation omitted); id. at 625 (“Had [plaintiffs] taken . . . the brand-name drug . . . their lawsuits would not be pre-empted. But because pharmacists . . . substituted generic metoclopramide instead, federal law pre-empts these lawsuits.”). Because it appears unlikely that Plaintiff can state a failure-to-warn claim based on Defendant’s failure to provide a Medication Guide to her pharmacy that avoids the application of both the learned-intermediary doctrine and Mensing, these claims are due to be dismissed with prejudice. It is unclear at this stage whether Plaintiff can assert a failure-to-warn claim that is not preempted under Mensing Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 8 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 9 of 15 Page 9 of 14 with respect to the content of Defendant’s warnings, so these claims are due to be dismissed without prejudice. Plaintiff’s request for an opportunity to amend her complaint is granted, and she must amend within twenty-one days from the date of this Order, as stated below. B. Off-Label Promotion Claims Defendant next contends that Plaintiff’s claims related to Defendant’s promotion of amiodarone for off-label uses are impliedly preempted because Plaintiff alleges a violation of FDA regulations dealing with prescription-drug marketing. According to Defendant, because Alabama has not imposed parallel state-law restrictions on the promotion of prescription drugs, Plaintiff is attempting to bring suit for violations of federal law. The Supreme Court has indeed stated that “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized to file suit for noncompliance with [FDA regulations].” Buckman Co., 531 U.S. at 349 n.4 (citing 21 U.S.C. § 337(a)). However, the Court has also declared that state law may “provid[e] a damages remedy for claims premised on a violation of FDA regulations.” Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008) (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)) (discussing preemption under 21 U.S.C. § 360(k)). It is thus possible for a private litigant to bring suit under state tort law for the violation of a duty that does Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 9 of 14Case 3:17-cv-02609-WHO Document 41-3 Filed 05/22/17 Page 10 of 15 Page 10 of 14 not “exist solely by virtue of the FDCA.” See Buckman Co., 531 U.S. at 353; see also Hughes v. Boston Sci. Corp., 631 F.3d 762, 775 (5th Cir. 2011) (holding that plaintiff’s claims alleging defendant’s “breach of the state duty by showing that [defendant] violated the FDA’s . . . regulations” were not preempted under Buckman Co.). Plaintiff alleges that Defendant’s promotion of amiodarone for the treatment of atrial fibrillation has influenced medical professionals and led them to believe that amiodarone is appropriate for such use, although it is not FDA-approved to treat atrial fibrillation and causes harmful side effects in atrial fibrillation patients. In short, Plaintiff alleges that Defendant misrepresented material facts about amiodarone both to the public and to medical professionals. Although Defendant’s off-label marketing of amiodarone may have violated the FDCA and its regulations, this Court is not convinced that Defendant’s duties with regard to the drug’s marketing “exist solely by virtue of the FDCA” so as to warrant implied preemption, see Buckman Co., 531 U.S. at 353, and this Court declines to dismiss Plaintiff’s claims on that basis. However, Plaintiff’s off-label promotion claims as presently pled are insufficient to state a claim for relief. As an initial matter, Plaintiff styles some of her claims as negligence claims, but the allegations speak only to fraud. See Ala. Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 10 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 11 of 15 Page 11 of 14 Code § 6-5-101 (including both intentional and negligent misrepresentation within the definition of legal fraud). Plaintiff does not plead negligence in Defendant’s marketing; rather, Plaintiff alleges that Defendant engaged in “concerted and systemic” promotional efforts to persuade medical professionals that amiodarone is appropriate to treat atrial fibrillation and approved for that use. This Court thus treats all of Plaintiff’s off-label promotion claims as fraud claims. “In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” Fed. R. Civ. P. 9(b). This heightened pleading standard requires the plaintiff “to plead the who, what, when, where, and how of the allegedly false statements and then allege generally that those statements were made with the requisite intent.” Mizzaro v. Home Depot, Inc., 544 F.3d 1230, 1237 (11th Cir. 2008). Specifically, the complaint must contain (1) precisely what statements were made in what documents or oral representations or what omissions were made; (2) the time and place of each such statement and the person responsible for making it; (3) the content of such statements and the manner in which they misled the plaintiff; and (4) what the defendant obtained as a consequence of the fraud. Id. (quoting Tello v. Dean Witter Reynolds, Inc., 494 F.3d 956, 972 (11th Cir. 2007)). Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 11 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 2 of 15 Page 12 of 14 On the whole, this Court understands Plaintiff’s off-label promotion claims to allege that amiodarone’s brand-name manufacturer-which is not a named defendant in this case-“actively promoted” amiodarone for off-label uses and induced physicians to prescribe the drug for those unapproved uses despite its knowledge of the danger to patients. According to Plaintiff, Defendant “took advantage of” the brand-name manufacturer’s “promotional efforts” and “engaged in [its own] campaign” to market the drug for the treatment of atrial fibrillation and thereby withheld information about the dangers of off-label use from the FDA, physicians, and the public. As a result, Plaintiff alleges, her physician was misled into believing that amiodarone was appropriate for the treatment of her atrial fibrillation, and Plaintiff used the drug as prescribed without knowledge of the potential side effects. Assuming these allegations constitute a fraud claim under Alabama law, the complaint does not describe the fraud with the requisite particularity. Plaintiff fails to identify a single statement in any promotional material to support her contention that Defendant unlawfully promoted amiodarone for the treatment of atrial fibrillation, and the allegedly fraudulent conduct described in the complaint principally relates to the brand-name manufacturer, rather than Defendant. But because it is unclear at this stage whether Plaintiff can assert a fraud claim for off- Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 12 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 13 of 15 Page 13 of 14 label promotion, the off-label promotion claims are due to be dismissed without prejudice. Plaintiff’s request for an opportunity to amend her complaint is granted, and she must amend within twenty-one days from the date of this Order, as stated below. C. Injunctive Relief Defendant initially argues that Plaintiff lacks standing to pursue the relief she seeks because she alleges no future harm. Indeed, the complaint states that Plaintiff ceased using amiodarone in July 2014. “Because injunctions regulate future conduct, a party has standing to seek injunctive relief only if the party alleges . . . a real and immediate . . . threat of future injury.” Church v. City of Huntsville, 30 F.3d 1332, 1337 (11th Cir. 1994) (emphasis in original). Despite the fact that Plaintiff alleges “continuing, present adverse effects,” id., as a result of using amiodarone, an injunction requiring Defendant to cease promoting amiodarone for the treatment of atrial fibrillation and to develop a process to distribute Medication Guides would not benefit Plaintiff because Plaintiff no longer uses the drug. Further, to the extent that Plaintiff requests injunctive relief to force Defendant to comply with the FDCA and related regulations, only the federal government has this right. 21 U.S.C. § 337(a) (“[A]ll such proceedings for the enforcement, or to restrain violations of [the FDCA] shall be by and in the name of the United Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 13 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 14 of 15 Page 14 of 14 States.”). Plaintiff’s claim for injunctive relief is thus due to be dismissed with prejudice. IV. Conclusion For the reasons stated above, Defendant’s motion to dismiss (Doc. 6) is hereby GRANTED. Plaintiff’s claims based on Defendant’s failure to provide a Medication Guide to her pharmacy and her claim for injunctive relief are DISMISSED WITH PREJUDICE. The remaining claims are DISMISSED WITHOUT PREJUDICE. Plaintiff has twenty-one (21) days from the date of this Order to amend her complaint consistent with this Order. DONE and ORDERED on March 9, 2017. _____________________________ L. Scott Coogler United States District Judge 186289 Case 2:16-cv-01246-LSC Document 20 Filed 03/09/17 Page 14 of 14Case 3:17-cv-02609-WHO ocu ent 41-3 Filed 05/22/17 Page 15 of 15 EXHIBIT D Case 3:17-cv-02609-WHO Document 41-4 Filed 05/22/17 Page 1 of 4 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF TEXAS AUSTIN DIVISION JOHN ANTHONY RUSK AND § JUDY RUSK, INDIVIDUALLY AND § AS ADMINISTRATOR OF THE § ESTATE OF JOHN ANTHONY RUSK, § PLAINTIFFS, § § V. § § WYETH-AYERST LABORATORIES, § INC.; SANDOZ INC.; TEVA § PHARMACEUTICALS USA INC.; § BARR LABORATORIES, INC.; AND § EONLABS, INC., § DEFENDANTS. § FILEE 20150C126 AMIJ:59 W1i c\/cJ' :L CAUSE NO. A-14-CV-549-LY ORDER ON REPORT AND RECOMMENDATION Before the court are Defendant Sandoz Inc.'s Dispositive Motion to Dismiss Plaintiffs' Complaint filed April 24,2015 (Doe. #21); Plaintiff's Response in Opposition to Defendant Sandoz Inc.'s Motion to Dismiss Complaint filed May 15, 2015 (Doe. #27); and Defendant Sandoz Inc.'s Reply in Support of its Motion to Dismiss filed May 22, 2015 (Doe. #29). The motion, response, and reply were referred to the United States Magistrate Judge for a Report and Recommendation as to the merits pursuant to 28 U.S.C. § 636(b), Rule 72 of the Federal Rules of Civil Procedure, and Rule 1(d) of Appendix C of the Local Rules of the United States District Court for the Western District of Texas. The magistrate judge filed his Report and Recommendation on June 11, 2015 (Doe. #34), recommending that this court grant the motion to dismiss without prejudice, dismiss Plaintiff's complaint, and grant Plaintiffs' "motion for leave to amend the complaint" contained in the response to the motion to dismiss. Case 1:14-cv-00549-LY Document 46 Filed 10/26/15 Page 1 of 3Case 3:17-cv-026 9-WHO t 1-4 Filed 05/22/17 Page 2 of 4 Defendant Sandoz Inc.'s Objections to the Magistrate's Report and Recommendation were filed June 25, 2015 (Doc. #35). Plaintiffs' Response to Objections to Magistrate's Recommendations was filed July 13, 2015 (Doc. #36). Plaintiffs' [Second Response to Defendant Sandoz's Objections to the Magistrate's Report and Recommendation was filed October 16, 2015 (Doc. #45). In light of Sandoz Inc.'s objections, the court has undertaken a de novo review of the entire case file and finds that the magistrate judge's Report and Recommendation should be approved and accepted by the court for substantially the reasons stated therein. Sandoz Inc.'s objections reurge the arguments thoroughly and properly addressed by the magistrate judge in his Report and Recommendation. Therefore, the court will overrule Sandoz Inc.'s objections. IT IS THEREFORE ORDERED that Defendant Sandoz Inc.'s Objections to the Magistrate's Report and Recommendation (Doc. #35) are OVERRULED. IT IS FURTHER ORDERED that the Report and Recommendation of the United States Magistrate Judge (Doc. #34) is ACCEPTED AND ADOPTED by the court. IT IS FURTHER ORDERED that Defendant Sandoz Inc.'s Dispositive Motion to Dismiss Plaintiffs' Complaint filed April 24, 2015 (Doc. #21) is GRANTED TO THE FOLLOWING EXTENT: Plaintiffs John Anthony Rusk and Judy Rusk's complaint is DISMISSED WITHOUT PREJUDICE. IT IS FURTHER ORDERED that Plaintiff John Anthony Rusk and Judy Rusk's "motion for leave to amend the complaint," contained in Plaintiff's Response in Opposition to Defendant Sandoz Inc.'s Motion to Dismiss Complaint (Doc. #27) is GRANTED TO THE FOLLOWING EXTENT: Plaintiffs shall file an amended complaint on or before November 13, 2015. Plaintiffs 2 Case 1:14-cv-00549-LY Document 46 Filed 10/26/15 Page 2 of 3Case 3:17-cv-026 9-WHO t 1-4 Filed 05/22/17 Page 3 of 4 may amend only their claims for wrongful off-label promotion and failure to supply adequate Medication Guides. In all other respects, the motion is denied. IT IS FINALLY ORDERED that the parties are to submit to the court a Proposed Agreed Scheduling Order, in accordance with Federal Rule of Civil Procedure 26(f), that follows the form scheduling order of this court located on the website for the United States District Court for the Western District of Texas (www.txwd.uscourts.gov), the "Forms" tab, "Civil," "Austin Division," "Proposed Scheduling Order for Judge Yeakel," on or before November 30, 2015. SIGNED this day of October, 2015. LEFJYEAKEL I U1'TED STATES DISTRICT JUDGE Case 1:14-cv-00549-LY Document 46 Filed 10/26/15 Page 3 of 3Case 3:17-cv-026 9-WHO t 1-4 Filed 05/22/17 Page 4 of 4 EXHIBIT E Case 3:17-cv-02609-WHO Document 41-5 Filed 05/22/17 Page 1 of 16 1 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF TEXAS AUSTIN DIVISION JOHN ANTHONY RUSK and JUDY RUSK, individually and as Administrator of the Estate of JOHN ANTHONY RUSK, Plaintiffs, V. WYETH-AYERHERST LABORATORIES, INC.; SANDOZ INC.; TEVA PHARMACEUTICALS USA INC.; BARR LABORATORIES, INC.; AND EON LABS; Defendants. § § § § § § § § § § § § A-14-CV-00549-LY-ML REPORT AND RECOMMENDATION OF THE UNITED STATES MAGISTRATE JUDGE TO THE HONORABLE LEE YEAKEL UNITED STATES DISTRICT JUDGE Before the Court are the Motion to Dismiss [Dkt. # 21] filed by Defendant Sandoz, Inc. (“Sandoz”), the Response in opposition thereto filed by Plaintiffs [Dkt. #27], and Sandoz’ Reply in support thereof [Dkt. #29].1 The Motions were referred by United States District Judge Lee Yeakel to the undersigned for a Report and Recommendation as to the merits pursuant to 28 U.S.C. § 636(b), Rule 72 of the Federal Rules of Civil Procedure, and Rule 1(d) of Appendix C of the Local Rules of the United States District Court for the Western District of Texas. After reviewing the pleadings, the relevant case law, as well as the entire case file, the undersigned issues the following Report and Recommendation to the District Court. 1 This Motion to Dismiss addresses claims against Sandoz only and does not implicate the Complaint against the other four defendants named as parties in this case. Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 1 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 2 of 16 2 I. BACKGROUND This is a product liability action against the makers and promoters of Cordarone® and its generic version, amniodarone. Cordarone is a pharmaceutical that was approved by the FDA in 1985 as “a drug of last resort for patients suffering from documented recurrent life-threatening ventricular fibrillation and ventricular tachycardia when these conditions would not respond to other available anti-arrhythmic drugs and therapies.” Compl. at ¶¶ 41-42. Amniodarone is the FDA-approved generic bioequivalent of Cordarone. Id. at ¶ 45. A. John Anthony Rusk’s Use of Amniodarone Plaintiffs allege John Anthony Rusk died from taking amniodarone, a generic version of Cordarone. Compl. ¶ 47. According to the Complaint, Mr. Rusk was prescribed a 90-day course of amniodarone as a treatment for atrial fibrillation, an “off-label” use of the drug. Id. at ¶ 47-48. Mr. Rusk filled his prescription on August 24, 2011 and took the drug as prescribed. Id. at ¶48. Mr. Rusk did not receive a Medication Guide, which outlines the risks and benefits of the drug, with his prescription. Id. at ¶ 50. He was not informed of the potentially fatal side effects associated with the drug. Id. Mr. Rusk was not aware that his use of the drug was an “off-label” use. Id. at ¶ 52. Amniodarone’s manufacturers are responsible for ensuring that Medication Guides are available for distribution to patients. 21 C.F.R. § 208.24. It is the end distributor (such as a pharmacy), however, that is responsible for actually providing the Medication Guide to the patient. See id. Mr. Rusk’s prescription was filled by a CVS pharmacy. Compl. at ¶ 48, n. 14. Plaintiffs allege that “According to the Pharmacies, no manufacturer is providing them or the patient’s [sic] medication guides.” Compl. at ¶ 137. The amniodarone tablets contained in Mr. Rusk’s prescription were marked with an NDC number identifying Defendant Sandoz as their Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 2 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 3 of 16 3 marketer, manufacturer, and distributor. Id. at ¶ 49. Plaintiffs assert Sandoz failed to ensure that the Medication Guide was provided to Rusk. Id. at ¶ 50. In the spring of 2012, Mr. Rusk began experiencing many of the side effects outlined in the amniodarone Medication Guide, including shortness of breath, wheezing, impaired vision, and leg, stomach, and chest cramps. Id. at ¶¶ 56, 58. Mr. Rusk died on May 1, 2012 at the age of 84. Id. at ¶ 59. Plaintiffs allege amniodarone-induced lung disease was a cause of death. Id. Plaintiffs have sued various pharmaceutical companies, including Sandoz, the maker of the amniodarone prescribed to Mr. Rusk. Plaintiffs allege the Defendants, specifically including Sandoz, were aware of increasing reports of adverse events related to off-label use of amniodarone between 1985, when Cordarone was initially approved in an abbreviated procedure, through the time it was prescribed to Mr. Rusk in 2011, through direct reports from health care providers and consumers, multiple official FDA label revision requirements, and through the FDA’s Adverse Event Reporting System (AERS). Id. at ¶¶ 61-83; 86-90. Plaintiffs allege the Defendants, specifically including Sandoz, nevertheless aggressively marketed amniodarone as a safe, first-line drug for various off-label cardiac therapies, such as that prescribed for Mr. Rusk. Id. at ¶¶ 92-96, 103-106. Plaintiffs allege the generic manufacturers, including Sandoz, actively promoted and “pushed” off-label use of amniodarone both through direct marketing and through “piggybacking” on the off-label marketing efforts of Defendant Wyeth, the manufacturer of the brand-name version of the drug. Id. at ¶¶ 92-105. Based on these factual allegations, Plaintiffs assert claims under Texas state law that the wrongful death of John Anthony Rusk was “directly and proximately caused by the negligent actions of the Defendants as related to the manufacture, marketing, distribution, and sale of Cordarone®/Amniodarone as described herein.” Id. at ¶ 131. Plaintiffs further allege the Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 3 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 4 of 16 4 Defendants “are guilty of gross negligence for failure to provide the FDA required medication guide,” id. at ¶ 138, and the failure to provide Mr. Rusk the medication guide was a direct and proximate cause of Plaintiff’s damages. Id. at ¶ 139. Defendant Sandoz has responded with a motion to dismiss, alleging that all of Plaintiffs’ claims are preempted by FDA regulations and that, in the alternative, Plaintiff’s generalized factual allegations are insufficient to satisfy Federal Rule of Civil Procedure 12(b)(6) and, to the extent Plaintiffs’ claims sound in fraud, Federal Rule of Civil Procedure 9(b). See generally Mot. Dism. [Dkt. #21]. B. The Unique Regulatory Framework Applicable to Generic Drugs Plaintiffs’ allegations must be read against the backdrop of the comprehensive regulatory scheme affecting the manufacture and sale of pharmaceuticals in the United States. Pursuant to the Federal Food, Drug and Cosmetic Act (“FDCA”), the FDA regulates the approval of both brand name and generic drugs. See 21 C.F.R. § 314.50(c)(2)(i) (brand name); 21 C.F.R. §314.94(a)(8) (generic). The amniodarone manufactured by Sandoz is a generic; therefore the court will focus here on the regulatory scheme applicable to generic drugs. Generic drugs are “designed to be a copy of a reference listed drug (typically a brand name drug), and thus identical in active ingredients, safety and efficacy.” PLIVA, Inc. v. Mensing,____ U.S. ____, 131 S.Ct. 2567, 2574 (2011). Recognizing this “duty of sameness,” the approval requirements for generic drugs are streamlined to require only submission of an Abbreviated New Drug Application (ANDA) showing a generic drug is identical in all material respects to a previously-approved reference drug. 21 U.S.C. § 355(j)(2)(A). These streamlined regulations require that the “labeling proposed [for an ANDA] is the same as the labeling approved for the [brand name drug].” Mensing, 131 S.Ct. at 2574 (citing 21 U.S.C. § 355(j)(2)(A)(v); 21 U.S.C. § 355(j)(4)(G)). Therefore, an ANDA applicant need only Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 4 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 5 of 16 5 demonstrate that its “warning label is the same as the brand name’s” to receive FDA approval. Mensing, 131 S.Ct at 2574. Upon receiving FDA approval of an ANDA, the only duty incumbent upon a generic manufacturer under federal law with respect to its warnings is an ongoing “duty of sameness” - to ensure its generic drug’s labeling remains identical to the Reference Listed Drug (“RLD”) to which it is required to remain equivalent. Id. at 2574-75. Generic manufacturers are prohibited from independently changing their labeling in any respect without prior FDA approval. Id. at 2577 (“Federal drug regulations, as interpreted by the FDA, prevented the manufacturers from independently changing their generic drugs’ safety labels.”); see also 21 C.F.R. § 314.150(b)(10) (authorizing FDA to revoke approval of a generic drug if its labeling “is no longer consistent with that for the listed drug”). This continuing federal “duty of sameness” extends beyond the labeling to the design of the drug as well. See generally Mutual Pharm. Co., Inc. v. Bartlett, ___ U.S. ____, 133 S.Ct. 2466 (2013). To gain and keep ANDA approval, generic manufacturers must show their products are bioequivalent to the brand name or reference listed drug. See 21 U.S.C. §355(j)(2)(A)(i)-(iii) (ANDA applicants must demonstrate that a generic drug contains the same active ingredients; employs the same route of administration; presents the same dosage form; and exhibits the same strength as its brand name counterpart). As the Mensing court explained, federal law explicitly requires a generic drug to be “identical [to its branded equivalent] in active ingredients, safety, and efficacy,” just as each generic drug must “ensur[e] that its warning label is the same as the brand name’s.” Mensing, 131 S.Ct at 2574 n.1. Because of this broadly applicable “duty of sameness,” the Supreme Court has held in both Mensing and Bartlett that product liability claims against generic drug manufacturers based on theories of “failure to warn” Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 5 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 6 of 16 6 or “design defect” are preempted by federal law. Mensing, 131 S.Ct. at 2577-78; Bartlett, 133 S.Ct. at 2480. II. STANDARD OF REVIEW Federal Rule of Civil Procedure 12(b)(6) allows the court to dismiss a claim that, on its face, “fails to state a claim upon which relief may be granted.” In reviewing a motion to dismiss for failure to state a claim, the court must accept as true all well-pleaded facts in the complaint, and must view the allegations as a whole in the light most favorable to the non-movant. Scanlan v. Texas A&M Univ., 343 F.3d 533, 536 (5th Cir. 2003); Collins v Morgan Stanley Dean Witter, 224 F.3d 496, 498 (5th Cir. 2000). Although Federal Rule of Civil Procedure 8 mandates only that a pleading contain a “short and plain statement of the claim showing that the pleader is entitled to relief,” this standard demands more than unadorned accusations, “labels and conclusions,” “a formulaic recitation of the elements of a cause of action,” or “naked assertion[s]” devoid of “further factual enhancement.” Bell Atl. v. Twombly, 550 U.S. 544, 555-57, 127 S. Ct. 1955, 1965-66 (2007). Thus, in considering a motion to dismiss, the court must initially identify pleadings that are no more than legal conclusions not entitled to the assumption of truth, then assume the veracity of well-pleaded factual allegations and determine whether those allegations plausibly give rise to an entitlement to relief. Ashcroft v. Iqbal, 556 U.S. 662, 679, 129 S. Ct. 1937, 1950 (2009). If not, “the complaint has alleged-but it has not ‘show[n]’-‘that the pleader is entitled to relief.’” Id. (quoting FED. R. CIV. P. 8(a)(2)). To the extent a complaint alleges claims sounding in fraud, Federal Rule of Civil Procedure 9(b) requires that plaintiffs go a step further: the underlying factual circumstances must be plead “with particularity.” Id. “Put simply, Rule 9(b) requires ‘the who, what, when, Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 6 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 7 of 16 7 where, and how’ to be laid out.” Benchmark Elecs. v. J.M. Huber Corp., 343 F.3d 719, 724 (5th Cir. Tex. 2003) (citing Williams v. WMX Techs., Inc., 112 F.3d 175, 179 (5th Cir. 1997)). III. ANALYSIS A. Preemption of Claims Based on Failure to Warn or Design Defect Defendants assert Plaintiffs’ claims fail as a matter of law because they are preempted by Mensing, 131 S.Ct. at 2577-78, and Bartlett, 133 S.Ct. at 2480. As noted above, Mensing holds that federal law preempts state law tort claims premised on alleged failure to warn of risks of generic drugs, because such claims conflict with federal law requiring generic manufacturers to conform their warnings to the equivalent brand name product. 131 S.Ct. at 2577-78. The Supreme Court reinforced and expanded Mensing’s scope to include design defect claims and claims alleging a duty to withdraw from the market in Bartlett, 133 S.Ct. at 2480. The Fifth Circuit has adopted a broad reading of both Mensing and Bartlett, upholding dismissals of a wide variety of claims whose factual allegations boil down to complaints of “failure to warn” or “design defect” as preempted by federal law. See, e.g., Lashley v. Pfizer, Inc., 750 F.3d 470, 474 and n.3 (5th Cir. 2014) (rejecting “parallel” state tort claims as preempted and noting in dicta that “failure to warn is the ‘only valid claim’ in a suit for personal injuries caused by prescription drugs in Texas); Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013) (Mensing forecloses all claims alleging “failure to communicate” approved warnings, and further preempts claims based on failure to test and inspect the product because “any ‘useful’ reporting [of the test results]-at least from the standpoint of those injured-would ostensibly consist of some sort of warning”); Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 186 (5th Cir. 2012) (“Post-Mensing, . . . a seeming majority of federal district courts to consider other state- Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 7 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 8 of 16 8 law tort claims have found them to be preempted based on the fact that the plaintiffs’ claims are failure-to-warn claims under different names.”). B. Negligent or Fraudulent “Off Label” Promotion Claims May Survive Despite its unhesitating application of Mensing and Bartlett preemption to a wide variety of claims implicating the federal “duty of sameness” in the labeling and design of generic drugs, the Fifth Circuit has recently “decided not to decide” whether a claim for negligent or fraudulent off-label promotion of a generic drug can survive Mensing and Bartlett preemption. See Whitener v. Pliva, Inc., No. 14-30468, 2015 U.S. App. LEXIS 5774, *10 (5th Cir. Apr. 9, 2015) (per curiam) (not designated for publication). The Whitener appellate court squarely recognized that “to the extent the Whiteners’ claims were based on the defendants’ affirmative promotion of metoclopramide for use during pregnancy [an off-label use], the district court was ‘unwilling to conclude that such a claim fails as a matter of law.’” Id. at *4 (quoting Whitener v. Pliva, No. 10-1552 Section “L” (4), 2011 U.S. Dist. LEXIS 140053, *15 (E.D. Louisiana Dec. 6, 2011)). Nevertheless, the district court ultimately granted summary judgment on the grounds that the plaintiffs had failed to establish causation on this potential cause of action, and the Fifth Circuit “affirm[ed] the district court’s dismissal of the Whiteners’ claim . .. without reaching whether the Whiteners’ off-label-promotion claim is a viable theory of recovery.” Id. at *10. The Fifth Circuit’s non-decision is, to date, the only federal appellate decision addressing the effect of Mensing and Bartlett preemption on allegedly wrongful “off label” promotional activities. However, the Whitener district court decision, reasoning that negligent or fraudulent off-label promotional activities would not be preempted by the “duty of sameness,” is in line with the opinions of several district courts to have considered the issue. For example, in Arters v. Sandoz, the United States District Court for the Southern District of Ohio specifically Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 8 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 9 of 16 9 considered the off-label promotion of amniodarone by Sandoz-the same generic drug and the same generic drug manufacturer before this court- and found that the plaintiffs’ legal theories “based on the idea that defendants promoted the drug in a fraudulent or unreasonably dangerous way” for off label use would not be preempted by federal law, because “Nothing in the FDCA requires defendants to promote their drug for an off-label use, nor is the federal law otherwise at odds with the negligence, breach of implied warranty, and fraud claims brought by plaintiffs.” 921 F. Supp. 2d 813, 819-20 (S.D. Ohio 2013). Earlier this year, in the related context of medical device regulation, the District of Hawaii considered similar preemption arguments in Beavers-Gabriel v. Medtronic, No. 13- 00686 JMS-RLP, 2015 U.S. Dist. LEXIS 2522 (D. Hawaii, Jan. 9, 2015). The court found no preemption where “Plaintiff’s allegations are not directed to the Infuse Device’s labeling- rather, Plaintiff asserts that Defendants failed to disclose relevant information regarding off-label uses of the Infuse Device to both the FDA and [plaintiff].” Id. (emphasis in original). A District Court in the Southern District of Texas may have put it best: “[T]he Court declines to find that any and all conduct that falls within the Plaintiffs’ allegations of promoting Risperdal for off- label uses in an illegal scheme necessarily fall within the concept of the regulation of labeling.” Elmore v. Gorsky, No. 2:12-CV-00347, 2012 U.S. Dist. LEXIS 177793, *8-9 (S.D. Tex. Dec. 17, 2012) (emphasis in original). Thus, while it is clear under Mensing that Sandoz “has no mechanism to unilateral provide any additional warnings relevant to the off-label use” of its drugs, several courts have found “the Mensing analysis changes if a generic defendant actively promotes the drug for off-label use in violation of federal law.” Whitener v. Pliva, No. 10-1552 Section “L” (4), 2012 U.S. Dist. LEXIS 127993, *6 (E.D. Louisiana, Sept. 10, 2012) (emphasis in original). The Fifth Circuit has declined to foreclose claims for wrongful off-label promotion, Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 9 of 15Case 3:17-cv 02609-WHO t 41-5 Filed 05/22/17 Page 10 of 16 10 despite its otherwise broad application of Mensing preemption. Whitener, 2015 U.S. App. LEXIS 5774, *10. It therefore appears that a claim for wrongful off-label promotion of a generic drug is potentially viable under current Fifth Circuit law. Id. 1. Elements of Wrongful “Off Label” Promotion Claims Sandoz argues that, even if a claim for wrongful off-label marketing is not preempted, Plaintiffs have failed to plead it with sufficient specificity to survive a motion to dismiss. Mot. Dism. [#21] at 12-18. The Whitener district court decision is instructive in terms of what must be plead to establish a claim for wrongful off-label marketing (assuming such a claim exists.) 2011 U.S. Dist. LEXIS 140053, *16. “If Plaintiffs wish to pursue such a claim they should plead sufficient factual content regarding what marketing or promotional representations were made, by which Defendants, to whom, and how those statements violated applicable federal law.” Id. 2 2. Plaintiffs Should Be Granted Leave to Re-Plead This Claim The Complaint as it stands alleges, inter alia: • Rusk’s specific amniodarone prescription was manufactured by Sandoz, Compl. at ¶ 49; • Defendants, “respectively, jointly and severally” had actual and constructive knowledge of severe (including fatal) side effects from off-label uses of amniodarone, including the side effects suffered by Mr. Rusk, from direct reports of adverse advents to the manufacturer by the purchasing healthcare provider or end-user patient, or through the FDA’s Adverse Event Reporting System (AERS). Id. at ¶¶ 86-88. 2 On summary judgment, the Whitener plaintiffs failed to establish causation because, although they had identified specific acts of off-label promotion, they had failed to obtain deposition testimony or other evidence that these promotions caused the plaintiff’s doctor to issue the off-label prescription. Whitener, 2015 U.S. App. LEXIS 5774, *10-12. Allegations of a “complex scheme to promote metoclopramide through congresses, doctors, and medical journals” was not substantiated by any evidence showing that the doctors “clinical judgment was itself influenced, in some indirect way, by the defendants’ promotional activities.” Id. (emphasis in original). Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 10 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 11 of 16 11 • Sandoz “and/or its agents’ pharmaceutical sales representatives actively promoted their generic amniodarone in the stream of commerce for the ‘off-label’ uses openly promoted by Defendant Wyeth.” Id. at ¶ 94. • Defendants, “respectively, jointly, and severally, concealed information about catastrophic injuries and death, and thousands of serious adverse medical events from the FDA, health care professionals, and consumers, including Anthony Rusk.” Id. at ¶ 97 • While Defendants “respectively, jointly and severally, concealed this adverse event information, they simultaneously engaged in a massive and fraudulent marketing and promotional scheme in which they aggressively and fraudulently promoted Cordarone®/amiodarone for uses never authorized by the FDA. In fact, Defendants marketed, promoted, and ‘pushed’ Cordarone®/amiodarone, not as a drug of last resort, but as a drug suitable as an initial therapy and to treat non-life- threatening heart conditions.” Id. at ¶ 100. • “Defendants’ affirmative misrepresentations and omissions have so infected the market in the United States that physicians and consumers relied on Defendants’ fraud, respectively, to the detriment of their patients and themselves.” Id. at ¶ 107. Sandoz contends these allegations are not specific enough to identify to whom or how Sandoz allegedly fraudulently marketed off-label use of amniodarone or concealed adverse events resulting from off-label use. Mot. Dism. [#21] at 17-18. The undersigned agrees. See FED. R. CIV. P. 9(b) (“In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”) Plaintiffs have sought leave to amend their complaint. Resp. [# 27] at 2. Leave to amend should be freely granted, particularly where the circumstances suggest amendment would not be futile. FED. R. CIV. P. 15(a)(2). In this case, Plaintiff’s claims for wrongful off-label promotion are not clearly foreclosed as a matter of law. Whitener, 2015 U.S. App. LEXIS 5774, *10. It is possible they will be able to amend their complaint to allege facts establishing both wrongful off- label promotion and reliance with the specificity required by Rule 9(b). Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 11 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 12 of 16 12 Should Plaintiffs wish to pursue this claim, they must amend their Complaint to identify, at a minimum, the promotional activities undertaken by agents or representatives of Sandoz to influence the specific physicians involved in Mr. Rusk’s treatment to prescribe amniodarone off- label and/or the actions taken by agents or representatives of Sandoz to conceal from Mr. Rusk’s physicians the risks associated with the off-label use of amniodarone in patients like Mr. Rusk. See Whitener, 2011 U.S. Dist. LEXIS 140053, *16; see also Beavers-Gabriel, 2015 U.S. Dist. LEXIS 2522, *16 (requiring that a complaint alleging fraudulent off-label promotion “include allegations making ‘the connection between Defendants’ alleged misdeeds and Plaintiff and Plaintiff’s phyisicians-i.e., that Plaintiff and Plaintiff’s physicians relied on the misrepresentations.’”) (quoting Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021, 1038 (D. Hawaii 2014). D. Failure to Supply FDA “Medication Guide” Claims May Survive Despite rejecting a variety of allegedly parallel state tort claims as preempted by Mensing and Bartlett, the Fifth Circuit recently held in Eckhardt v. Qualitest Pharms., Inc., 751 F.3d 674, 679 (5th Cir. 2014) that an allegation that generic drug manufacturers “failed to provide [plaintiff] or his physician with any of the FDA-approved warnings . . .. would be a violation of both state and federal law, [and] this is a parallel claim that is not preempted.” Id. at 679-80. Plaintiffs in this case allege that Defendant Sandoz was responsible for providing an FDA- mandated “Medication Guide.” Compl. at ¶¶ 50, 54. Plaintiffs further allege that Mr. Rusk never received the Medication Guide, id. at ¶ 50, and that “the Pharmacies” assert “no manufacturer” was providing the Guides to pharmacists or patients. Id. at ¶ 137. To the extent Plaintiffs seek to allege that Sandoz failed to comply with its obligation to supply distributors with the FDA-required Medication Guides, and this failure proximately caused Mr. Rusk to take Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 12 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 13 of 16 13 amniodarone without knowledge of the FDA-approved warnings, such a claim would survive federal preemption under Eckhardt’s reasoning. 751 F.3d at 679. 1. Elements of Failure to Supply FDA Medication Guide Claim Defendant Sandoz again asserts that, even if the alleged failure to supply a Medication Guide is viable as a matter of law, it has not been adequately alleged in this case. Mot. Dism. [#21] at 19. Recently, the District Court for the Northern District of Alabama considered what would be required to plead a claim for failure to provide an FDA-mandated Medication Guide. Stevens v. Teva Pharmaceuticals, No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Alabama, Oct. 1, 2014). “Without a well-founded allegation that Huntsville Hospital Pharmacy [the pharmacy that filled the plaintiff’s prescription] failed to provide a Medication Guide to Plaintiff because defendants did not supply the Guide to the pharmacy along with the medication, as required by 21 C.F.R. § 208.24, this claim cannot survive.” Id. at *8. 2. Plaintiffs Should be Granted Leave to Re-Plead this Claim Plaintiffs have generally alleged that unknown pharmacies have complained about not receiving Medication Guides from unknown manufacturers. Compl. at ¶ 137. There is no allegation in the Complaint, however, that the CVS that filled Mr. Rusk’s prescription was unable to provide him a Medication Guide because Sandoz failed to supply one to CVS. See Stevens, 2014 U.S. Dist. LEXIS 180568 at *8. Therefore, Plaintiffs have not plead this claim with sufficient factual specificity to raise it above the level of “a sheer possibility that the defendant has acted unlawfully.” Id. (citing Iqbal, 556 U.S. at 678). Because there is no suggestion that amendment of this claim would be futile, Plaintiffs should be granted leave to re- plead their claim for failure to provide a Medication Guide with the requisite specificity. FED. R. CIV. P. 15(a)(2). Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 13 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 14 of 16 14 IV. RECOMMENDATIONS In accordance with the foregoing, the undersigned RECOMMENDS that Defendant’s Motion to Dismiss [#21] be GRANTED WITHOUT PREJUDICE. The undersigned further RECOMMENDS Plaintiffs’ Motion for Leave to Amend be GRANTED. Specifically, the undersigned RECOMMENDS that Plaintiffs be granted leave to amend only their claims for wrongful off-label promotion and failure to supply adequate Medication Guides, as the remainder of their claims for relief “related to the manufacture, marketing, distribution, and sale of amniodarone,” Compl. at ¶ 131, are preempted as a matter of law. V. OBJECTIONS The parties may file objections to this Report and Recommendation. A party filing objections must specifically identify those findings or recommendations to which objections are being made. The District Court need not consider frivolous, conclusive, or general objections. See Battles v. United States Parole Comm’n, 834 F.2d 419, 421 (5th Cir. 1987). A party's failure to file written objections to the proposed findings and recommendations contained in this Report within fourteen (14) days after the party is served with a copy of the Report shall bar that party from de novo review by the District Court of the proposed findings and recommendations in the Report and, except upon grounds of plain error, shall bar the party from appellate review of unobjected-to proposed factual findings and legal conclusions accepted by the District Court. See 28 U.S.C. § 636(b)(1)(C); Thomas v. Arn, 474 U.S. 140, 150-53, 106 S. Ct. 466, 472-74 (1985); Douglass v. United Services Automobile Ass’n, 79 F.3d 1415 (5th Cir. 1996)(en banc). Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 14 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 15 of 16 15 To the extent that a party has not been served by the Clerk with this Report & Recommendation electronically, pursuant to the CM/ECF procedures of this District, the Clerk is ORDERED to mail such party a copy of this Report and Recommendation by certified mail, return receipt requested. SIGNED June 11, 2015 _______________________________ MARK LANE UNITED STATES MAGISTRATE JUDGE Case 1:14-cv-00549-LY Document 34 Filed 06/11/15 Page 15 of 15Case 3:17-cv-026 9-WHO t 41-5 Filed 05/22/17 Page 16 of 16 EXHIBIT F Case 3:17-cv-02609-WHO Document 41-6 Filed 05/22/17 Page 1 of 4 Case 1:14-cv-00549-LY Document 71 Filed 09/07/16 Page 1 of 3 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF TEXAS AUSTIN DIVISION JOHN ANTHONY RUSK AND JUDY RUSK, INDIVIDUALLY AND AS ADMINISTRATOR OF THE ESTATE OF JOHN ANTHONY RUSK, FILED 16 SEP -1 PH t.: 02 CLERK. U.S. DISTRICT C RT 5 WESTERN DISTRICT T BY--~~~!:~;'ii PLAINTIFFS, § § § § § § § § § § CAUSE NO. 1:14-CV-549-LY SANDOZ, INC., DEFENDANTS. ORDER ON REPORT AND RECOMMENDATION Before the court are Defendant Sandoz Inc.' s Dispositive Motion to Dismiss Plaintiffs' First Amended Complaint filed November 30, 2015 (Clerk's Doc. No. 50); Plaintiff's Response in Opposition to Defendant Sandoz Inc.'s Motion to Dismiss filed December 22, 2015 (Clerk's Doc. No. 54); and Defendant Sandoz Inc.'s Reply in Support of its Motion to Dismiss filed January 4, 2016 (Clerk's Doc. No. 55). The motion, response, and reply were referred to the United States Magistrate Judge for a Report and Recommendation as to the merits. See 28 U.S.C. § 636(b); Fed. R. Civ. P. 72; W.D. Tex. Appx C, R. l(d). The magistrate judge filed his Report and Recommendation on July 28, 2016 (Clerk's Doc. No. 65), recommending that this court grant in part and deny in part the motion to dismiss, and deny Plaintiffs' motion for leave to amend the complaint contained in the response to the motion to dismiss. A party may serve and file specific, written objections to the proposed findings and recommendations of the Magistrate Judge within 14 days after being served with a copy of the Report and Recommendation, and thereby secure a de nova review by the District Court. 28 Case 3:17-cv-026 9-WHO t 4 -6 Filed 05/22/17 Page 2 of 4 Case 1:14-cv-00549-LY Document 71 Filed 09/07/16 Page 2 of 3 U.S.C. § 636(b); Fed. R. Civ. P. 72(b). A party's failure to timely file written objections to the proposed findings, conclusions, and recommendation in a Report and Recommendation bars that party, except upon grounds of plain error, from attacking on appeal the unobjected-to proposed factual findings and legal conclusions accepted by the District Court. See Douglass v. United Services Auto Ass'n, 79 F.3d 1415 (5th Cir. 1996) (en bane). The record reflects that the parties received the Report and Recommendation on July 28, 2016. Plaintiffs timely filed objections on August 8, 2016 (Clerk's Doc. No. 66), and Defendants timely filed objections on August 22, 2016 (Clerk's Doc. No. 67). Defendant filed a response to Plaintiffs' objections on September 2, 2016 (Clerk's Doc. No. 70). In light of the parties' objections, the court has undertaken a de nova review of the motions, response, reply, objections, response to objections, applicable law, and case file. The court concludes that the objections reurge the arguments thoroughly and properly addressed by the magistrate judge in his Report and Recommendation, Therefore, the court will overrule Sandoz Inc.'s objections and approve and adopt the magistrate judge's Report and Recommendation for substantially the reasons stated therein. IT IS THEREFORE ORDERED that Plaintiffs Partial Objection to Magistrate Judge Mark Lane's Report and Recommendation (Clerk's Doc. No. 66) is OVERRULED. IT IS FURTHER ORDERED that Defendant Sandoz Inc.'s Partial Objections to the Magistrate's July 28, 2016 Report and Recommendation (Clerk's Doc. No. 67) are OVERRULED. IT IS FURTHER ORDERED that the Report and Recommendation of the United States Magistrate Judge (Clerk's Doc. No. 65) is ACCEPTED AND ADOPTED by the court. 2 Case 3:17-cv-026 9-WHO t 4 -6 Filed 05/22/17 Page 3 of 4 Case 1:14-cv-00549-LY Document 71 Filed 09/07/16 Page 3 of 3 IT IS FURTHER ORDERED that Defendant Sandoz Inc.'s Dispositive Motion to Dismiss Plaintiffs' First Amended Complaint (Clerk's Doc. No. 50) is GRANTED TO THE FOLLOWING EXTENT: Plaintiffs John Anthony Rusk and Judy Rusk's claims of wrongful death and off-label marketing are DISMISSED with prejudice. In all other respects, the motion is DENIED. IT IS FURTHER ORDERED that Plaintiff John Anthony Rusk and Judy Rusk's motion for leave to amend their complaint, contained in Plaintiffs Response in Opposition to Defendant Sandoz Inc.'s Motion to Dismiss Complaint (Clerk's Doc. No. 54) is DENIED. SIGNED this 'Ut day of September, 2016. ~ ~ ~~ LEYEKEL 3 Case 3:17-cv-026 9-WHO t 4 -6 Filed 05/22/17 Page 4 of 4 EXHIBIT G Case 3:17-cv-02609-WHO Document 41-7 Filed 05/22/17 Page 1 of 3 ATL 22056813v1 Streed et al. v. Wyeth Pharmaceuticals, et al. U.S. DISTRICT COURT OF NORTHERN CALIFORNIA, CASE NO. 3:17-CV-02609 CHART OF APPLICABLE STATUTE OF LIMITATIONS PLAINTIFF'S NAME STATE OF RESIDENCE ACCRUAL DATE- Date of Alleged Onset of Symptoms (or Diagnosis of Amiodarone- Induced Condition) CITATION IN FIRST AMENDED COMPLAINT APPLICABLE STATUTE OF LIMITATIONS COBB, JEROME (Estate of Genelle Cobb, Mother) Alabama Winter 2014 ¶4(g) 2 Years - Alabama Stat. § 6-2-38 DUNCAN, ELMO WAYNE Alabama November 2014 ¶34(g) 2 Years - Alabama Stat. § 6-2-38 RHODES, SANDRA Alabama December 2011 ¶5(g) 2 Years - Alabama Stat. § 6-2-38 MEDFORD, NOAH California February 2015 ¶16(g) 2 Years - Cal. Civ. Proc. Code §335.1 ACKERMAN, HENRY Georgia October 2014 ¶29(g) 2 Years (or 1 Year from date of death) - Official Code of Georgia Ann. § 9-3-33 BUSSELL, DORIS Georgia February 2007 ¶25(g) 2 Years (or 1 Year from date of death) - Official Code of Georgia Ann. § 9-3-33 COONTZ, JENNITH Kentucky August 2015 ¶21(g) 1 year - Kentucky Revised Statutes § 413.140(1)(a) BIVINS, EDWARD L. Michigan March 2014 ¶7(g) 3 years - Michigan Compiled Laws Ann. § 600.5805(13) Case 3:17-cv-02609-WHO Document 41-7 Filed 05/22/17 Page 2 of 3 ATL 22056813v1 JENKINS, EVANS North Carolina September 2012 ¶30(g) Strict products liability: 3 years - N.C.G.S.A. § 1-52(16). For Personal Injury: 3 Years - N.C.G.S.A. § 1-52(1)-(5) MURPHY, WILLIAM Ohio May 2012 ¶17(g) 2 years - Ohio Revised Code Ann. § 2305.10(A) AYERS, WILLIE South Carolina November 2008 ¶28(g) 3 years - South Carolina Code Ann. §§ 15- 3-530, 15-3-535 BURNS, THOMAS Tennessee February 2016 ¶24(g) 1 year - Tennessee Code Ann. § 28-3-104 HART, SHIRLEY Texas May 2010 ¶9(g) 2 years - Tex. Civ. Prac. & Rem. Code Ann. § 16.003 Case 3:17-cv-02609-WHO Document 41-7 Filed 05/22/17 Page 3 of 3 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 1 CASE NO. 3:17-CV-2609-WHO DEFENDANTS SANDOZ INC. AND EON LABS, INC.’S REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS FIRST AMENDED COMPLAINT GREENBERG TRAURIG, LLP LORI G. COHEN (admitted pro hac vice) SARA K. THOMPSON (admitted pro hac vice) Terminus 200 3333 Piedmont Road NE, Suite 2500 Atlanta, GA 30305 Telephone: (678) 553-2100 Facsimile: (678) 553-2212 cohenl@gtlaw.com thompsons@gtlaw.com NATASSIA KWAN (SBN 294322) 4 Embarcadero Center, Suite 3000 San Francisco, CA 94111 Telephone: (415) 655-1300 Facsimile: (415) 707-2010 kwann@gtlaw.com GREG SPERLA (SBN 278062) 1201 K Street, Suite 1100 Sacramento, California 95814 Telephone: (916) 442-1111 Facsimile: (916) 448-1709 sperlag@gtlaw.com Attorneys for Defendants SANDOZ INC. and EON LABS, INC. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA EDWIN STREED; et al. Plaintiffs, v. WYETH PHARMACEUTICALS, INC; et al., Defendants. CASE NO. 3:17-CV-2609-WHO DEFENDANTS SANDOZ INC.’S AND EON LABS, INC.’S REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF Fed. R. Civ. P. 12(b)(6) Date: July 19, 2017 Time: 2:00 p.m. Judge: Hon. William H. Orrick Courtroom: 2, 17th Floor Filed/Lodged Concurrently with: 1. Defendants’ Motion to Dismiss 2. [Proposed] Order Case 3:17-cv-02609-WHO Document 41-8 Filed 05/22/17 Page 1 of 3 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 2 CASE NO. 3:17-CV-2609-WHO DEFENDANTS SANDOZ INC. AND EON LABS, INC.’S REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS FIRST AMENDED COMPLAINT Pursuant to Federal Rule of Evidence 201(b) and supporting case law, Defendants Sandoz Inc. (“Sandoz”) and Eon Labs, Inc. (“Eon”) respectfully request that the Court take judicial notice of the following exhibits attached to this Request for Judicial Notice in support of Sandoz and Eon’s Motion to Dismiss Plaintiffs’ First Amended Complaint and Memorandum of Points and Authorities in Support Thereof (“Motion to Dismiss”): 1. Exhibit A. The Federal Drug Administration’s Drugs@FDA webpage for Sandoz and Eon’s amiodarone H hydrochloride ANDA #75315, viewed and printed on May 18, 2017, and available at https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. 2. Exhibit B. The Federal Drug Administration’s approval letter dated December 23, 1998, for ANDA #75-315, for Eon’s Amiodarone Hydrochloride Tablets, 200 mg, viewed and printed on May 18, 2017, and available at https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75315ltr.pdf. A court may properly consider documents subject to judicial notice in deciding a motion to dismiss. See Outdoor Media Group, Inc. v. City of Beaumont, 506 F.3d 895, 899 (9th Cir. 2007). Documents outside of the complaint that are capable of accurate and ready determination by resort to resources whose accuracy cannot reasonably by questioned are proper for judicial notice. FED. R. EVID. 201(b)(2). “It is appropriate to take judicial notice of [information on a government website], as it was made publicly available by government entities.” Daniels-Hall v. Nat’l Educ. Ass’n, 629 F.3d 992, 998- 99 (9th Cir. 2010); see also, e.g., Cty. of Santa Clara v. Trump, No. 17-CV-00485-WHO, 2017 WL 1459081, at *4 n2 (N.D. Cal. Apr. 25, 2017) (“[C]ourts may judicially notice information and official documents contained on official government websites.”); In re Amgen Inc. Sec. Litig., 544 F. Supp. 2d 1009, 1023 (C.D. Cal. 2008) (taking judicial notice of drug labels taken from the FDA’s website as documents “capable of accurate and ready determination” and “not subject to reasonable dispute” (citing FED. R. EVID. 201(d)); Cty. of Santa Clara v. Astra USA, Inc., 401 F. Supp. 2D 1022, 1023 (N.D. Cal. 2005) (taking judicial notice of information posted on a Department of Health and Human Services website) (citing FED. R. EVID. 201). Pursuant to these authorities, the information made publicly available by the Federal Drug Administration (attached as Exhibits A and B) is appropriate for judicial notice and may be considered by the Court in ruling on the Motion to Dismiss. Case 3:17-cv-02609-WHO Document 41-8 Filed 05/22/17 Page 2 of 3 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 3 CASE NO. 3:17-CV-2609-WHO DEFENDANTS SANDOZ INC. AND EON LABS, INC.’S REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS FIRST AMENDED COMPLAINT For the foregoing reasons, Sandoz and Eon respectfully request that the Court take judicial notice of Exhibits A and B in ruling on the Motion to Dismiss. DATED: May 22, 2017 GREENBERG TRAURIG, LLP By /s/ Greg Sperla Lori S. Cohen (admitted pro hac vice) Sara K. Thompson (admitted pro hac vice) Greg Sperla Attorneys for Defendants SANDOZ INC. and EON LABS, INC. Case 3:17-cv-02609-WHO Document 41-8 Filed 05/22/17 Page 3 of 3 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 1 CASE NO. 3:17-CV-2609-WHO [PROPOSED] ORDER GRANTING DEFENDANTS SANDOZ INC.’S AND EON LABS, INC.’S MOTION TO DISMISS FIRST AMENDED COMPLAINT GREENBERG TRAURIG, LLP LORI S. COHEN (admitted pro hac vice) SARA K. THOMPSON (admitted pro hac vice) Terminus 200 3333 Piedmont Road NE, Suite 2500 Atlanta, GA 30305 Telephone: (678) 553-2100 Facsimile: (678) 553-2212 cohenl@gtlaw.com thompsons@gtlaw.com Natassia Kwan (SBN 294322) 4 Embarcadero Center, Suite 3000 San Francisco, CA 94111 Telephone: (415) 655-1300 Facsimile: (415) 707-2010 kwann@gtlaw.com Greg Sperla (SBN 278062) 1201 K Street, Suite 1100 Sacramento, California 95814 Telephone: (916) 442-1111 Facsimile: (916) 448-1709 sperlag@gtlaw.com Attorneys for Defendants SANDOZ INC. and EON LABS, INC. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA EDWIN STREED; et al. Plaintiffs, v. WYETH PHARMACEUTICALS, INC; et al., Defendants. CASE NO. 3:17-CV-2609-WHO [PROPOSED] ORDER GRANTING DEFENDANTS SANDOZ INC.’S AND EON LABS, INC.’S MOTION TO DISMISS FIRST AMENDED COMPLAINT Date: July 19, 2017 Time: 2:00 p.m. Judge: Hon. William H. Orrick Courtroom: 2, 17th Floor Case 3:17-cv-02609-WHO Document 41-9 Filed 05/22/17 Page 1 of 2 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 2 CASE NO. 3:17-CV-2609-WHO [PROPOSED] ORDER GRANTING DEFENDANTS SANDOZ INC.’S AND EON LABS, INC.’S MOTION TO DISMISS FIRST AMENDED COMPLAINT TO THE CLERK OF COURT AND TO ALL PARTIES AND HTEIR ATTORNEYS OF RECORD HEREIN: Sandoz Inc. and Eon Labs, Inc.’s Motion to Dismiss First Amended Complaint pursuant to Rule 12 of the Federal Rules of Civil Procedure in the above-referenced matter was heard on July 19, 2017, at 2:00 p.m., in the above-referenced court. Sandoz Inc. and Eon Labs, Inc. were represented by Greenberg Traurig LLP, all other appearances were noted on the record. Upon consideration of all the pleadings, and written and oral argument presented by all parties, and good cause appearing therefore, IT IS HEREBY ORDERED that: Sandoz Inc., and Eon Labs, Inc.’s Motion to Dismiss Plaintiff’s First Amended Complaint is GRANTED with prejudice. DATED: _____________________ __________________________________ Honorable Judge William H. Orrick United States District Judge Case 3:17-cv-02609-WHO Document 41-9 Filed 05/22/17 Page 2 of 2