Streed et al V Wyeth Pharmaceuticals, Inc. et Al.,MOTION to Dismiss for Lack of JurisdictionN.D. Cal.May 22, 20171 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 G. Gregg Webb (SBN: 298787) gwebb@shb.com SHOOK, HARDY & BACON L.L.P. One Montgomery, Suite 2700 San Francisco, California 94104-4505 Telephone: 415.544.1900 Facsimile: 415.391.0281 Attorneys for Defendant UPSHER-SMITH LABORATORIES, INC. IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA EDWIN STREED; MARGARET STREED; SHIRLEY MILLER; PHYLLIS BENNETT, individually and as Executor of the Estate of Harvey Bennett; JEROME COBB, individually and on behalf of his Deceased Mother, Genelle Cobb; SANDRA RHODES; CHARLES RHODES; ERNESTINE SALVO, individually and as Personal Representative of the Estate of Theodore Salvo; EDWARD L. BIVINS; SANDRA BIVINS; ARTHUR OLSTAD; KATHLEEN OLSTAD; SHIRLEY HART; ROBERT PERKINS; LARRY SLUSSER; JANICE SUSAN SLUSSER; ELIZABETH CLARK; JOSEPH HUDOCK; RICHARD REED; VICKI REED; RAY J. HUBLER; MAIRE HUBLER; NOAH MEDFORD; KAREN MEDFORD; WILLIAM MURPHY; BONNIE MURPHY; JAMES CALVIN; HELEN CALVIN; ROBERT SMITH; CATHY SMITH, PATRICIA SOPP, individually and as Administrator of the Estate of Philip C. Sopp; JEROME COBB; JENNITH COONTZ; DONALD COONTZ; RITA M. WEAVER; MARVIN BAUMAN; ROWENA BAUMAN; THOMAS BURNS; SUE BURNS; DORIS BUSSELL; FRANCIS GROMADZKI; LEE ANN GROMADZKI; THOMAS GLEW; MARYANN GLEW; WILLIE AYERS; HENRY ACKERMAN; GENIEVE ACKERMAN; EVANS JENKINS; DONALD HACKERSON; CAROLYN HACKERSON; MICHAEL WENDE; EILEEN POWELL, individually and as Personal Representative of the Estate of Robert Powell; ELMO WAYNE DUNCAN; JAMES CIAVARDINI; JEAN CIAVARDINI; JAMES WALZ; MARY BETH WALZ; EDGAR RAY HERTEL; Case No. 3:17-cv-02609-WHO (Removed from the Superior Court of the State of California, County of Alameda, Case No. RG17854340) DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT AND MEMORANDUM OF POINTS AND AUTHORITIES Date: July 19, 2017 Time: 2:00 p.m. Courtroom: 2, 17th Floor Judge: Hon. William H. Orrick Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 1 of 34 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 DONNA HERTEL; TRIO CALDWELL; BEVERLY CALDWELL; JUDITH COTE; Plaintiffs, v. WYETH PHARMACEUTICALS, INC.; SANDOZ INC.; EON LABS, INC.; TEVA PHARMACEUTICALS USA, INC.; PAR PHARMACEUTICAL COMPANIES, INC.; ZYDUS PHARMACEUTICALS USA, INC.; TARO PHARMACEUTICALS USA, INC.; UPSHER-SMITH LABORATORIES, INC.; BARR PHARMACEUTICALS, INC.; MAYNE PHARMA, INC.; MCKESSON CORPORATION; and DOES 1-50, Inclusive, Defendants. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 2 of 34 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 i DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO TABLE OF CONTENTS MOTION TO DISMISS ................................................................................................................. 1 MEMORANDUM OF POINTS AND AUTHORITIES ................................................................ 2 INTRODUCTION AND SUMMARY OF ARGUMENT ............................................................. 2 STATEMENT OF FACTS ............................................................................................................. 4 STANDARD OF REVIEW ............................................................................................................ 5 I. Lack of Personal Jurisdiction .............................................................................................. 5 II. Failure to State a Claim....................................................................................................... 6 ARGUMENT ................................................................................................................................. 7 I. Plaintiffs’ Claims Against Upsher-Smith Should Be Dismissed for Lack of Personal Jurisdiction .......................................................................................................................... 7 A. The Court lacks general jurisdiction over Upsher-Smith. ...................................... 7 B. The Court lacks specific jurisdiction over Upsher-Smith because Plaintiffs have not pleaded facts showing that their claims arise from Upsher-Smith’s California contacts. ................................................................................................. 8 II. Plaintiffs’ Inadequate Warnings Claims Are Preempted. ................................................. 12 III. Plaintiffs’ “Medication Guide” Allegations Are Preempted and Otherwise Fail to State a Claim ..................................................................................................................... 14 A. Plaintiffs cannot bring a private action to enforce the federal medication guide regulations. ............................................................................................................ 15 B. Plaintiffs’ medication guide claims fail because Plaintiffs have not plausibly alleged that McKesson was the distributor of the amiodarone they ingested. ...... 17 C. Plaintiffs’ medication guide claims fail because Plaintiffs have not plausibly alleged that Upsher-Smith failed to comply with the medication guide regulations. ............................................................................................................ 17 IV. Plaintiffs’ Allegations of “Off-Label” Promotion Are Preempted and Otherwise Fail to State a Claim ................................................................................................................. 19 V. Plaintiffs’ Product Defect Allegations Do Not State a Claim........................................... 21 VI. Plaintiffs’ Allegations Do Not Satisfy Federal Pleading Requirements ........................... 22 CONCLUSION ............................................................................................................................. 25 Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 3 of 34 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 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO TABLE OF AUTHORITIES Page(s) CASES Adams v. I-Flow Corp., No. CV09-09550, 2010 WL 1339948 (C.D. Cal. Mar. 30, 2010) .......................................9, 22, 23 Addelson v. Sanofi S.A., No. 4:16-cv-01277 ERW, 2016 WL 6216124 (E.D. Mo. Oct. 25, 2016) ......................................11 Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 WL 178038 (N.D. Ala. Jan. 14, 2015) ........................................18 Anderson v. Jamba Juice Co., 888 F. Supp. 2d 1000 (N.D. Cal. 2012) ...........................................................................................4 Anderson v. Medtronic, Inc., No. 14-cv-00615, 2015 WL 2115342 (S.D. Cal. May 6, 2015) ..............................................16, 20 Arnold v. Goldstar Fin. Sys., Inc., No. 01-C-7694, 2002 WL 1941546 (N.D. Ill. Aug. 22, 2002) ......................................................11 Asahi Metal Indus. Co. v. Superior Ct., 480 U.S. 102 (1987) .........................................................................................................................6 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ............................................................................................................... passim Ballard v. Savage, 65 F.3d 1495 (9th Cir. 1995) ...........................................................................................................5 Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) .....................................................................................................................6, 7 Boschetto v. Hansing, 539 F.3d 1011 (9th Cir. 2008) .........................................................................................................5 Brinkley v. Pfizer, Inc., 772 F.3d 1133 (8th Cir. 2014) .......................................................................................................22 Bristol-Myers Squibb Co. v. Superior Court, 377 P.3d 874 (Cal. 2016), cert. granted, 137 S. Ct. 827 (2017) ...................................................12 Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) ............................................................................................................... passim Cahen v. Toyota Motor Corp., 147 F. Supp. 3d 955 (N.D. Cal. 2015), appeal filed, No. 16-15496 (9th Cir.) ..............................11 Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 4 of 34 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 iii DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO Capital Equip., Inc. v. CNH Am., LLC, 394 F. Supp. 2d 1054 (E.D. Ark. 2005) .........................................................................................10 Carpenter v. Sikorsky Aircraft Corp., 101 F. Supp. 3d 911 (C.D. Cal. 2015) ...........................................................................................11 Connolly v. Sandoz Pharms. Corp., No. 2:14-cv-152-WCO, 2014 WL 12480025 (N.D. Ga. Dec. 23, 2014) .............................2, 13, 19 Daimler AG v. Bauman, 134 S. Ct. 746 (2014) .................................................................................................................8, 10 Destfino v. Reiswig, 630 F.3d 952 (9th Cir. 2011) .........................................................................................................24 Drager v. PLIVA USA, Inc., 741 F.3d 470 (4th Cir. 2014) ...................................................................................................13, 22 Dreher v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 WL 3948961 (N.D. Ala. June 29, 2015) ...........................2, 13, 16 Dunbar v. Medtronic, Inc., No. CV 14-01529-RGK, 2014 WL 3056026 (C.D. Cal. June 25, 2014) ...........................16, 19, 20 Ebeid ex rel. United States v. Lungwitz, 616 F.3d 993 (9th Cir. 2010) .........................................................................................................24 Elliott v. Sandoz, Inc., No. 2:16-cv-00861-RDP, 2016 WL 4398407 (N.D. Ala. Aug. 18, 2016), appeal dismissed, No. 16-16529-FF (11th Cir. Jan. 5, 2017) ................................................................2, 16 Evergreen Int’l Airlines, Inc. v. Anchorage Advisors, LLC, No. 3:11-cv-1416-PK, 2012 WL 3637551 (D. Or. July 9, 2012) ..................................................11 Fullington v. Pfizer, Inc., 720 F.3d 739 (8th Cir. 2013) .........................................................................................................13 Gaeta v. Perrigo Pharm. Co., 469 F. App’x 556 (9th Cir. 2012) ..................................................................................................13 Gauvin v. Trombatore, 682 F. Supp. 1067 (N.D. Cal. 1988) ................................................................................................9 Glater v. Eli Lilly & Co., 744 F.2d 213 (1st Cir. 1984) ..........................................................................................................11 Goldsmith v. Allergan, Inc., No. CV 09-7088, 2011 WL 147714 (C.D. Cal. Jan. 13, 2011) .....................................................20 Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 5 of 34 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 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011) .................................................................................................................6, 7, 8 Grant v. Corin Group PLC, No. 3:15-CV-169-CAB-BLM, 2016 WL 4447523 (S.D. Cal. Jan. 15, 2016) ...............................16 Guarino v. Wyeth LLC, 719 F.3d 1245 (11th Cir. 2013) .....................................................................................................13 Gustavson v. Wrigley Sales Co., 961 F. Supp. 2d 1100 (N.D. Cal. 2013) ...........................................................................................4 Helicopteros Nacionales de Columbia, S.A. v. Hall, 466 U.S. 408 (1984) .........................................................................................................................6 Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal. 2013) ...................................................................................16, 20 In re: Bard IVC Filters Prods. Liab. Litig., No. CV-16-02853-PHX-DGC, 2016 WL 6393596 (D. Ariz. Oct. 28, 2016) ................................11 In re Darvocet, Darvon and Propoxyphene Prods. Liab. Litig, 756 F.3d 917 (6th Cir. 2014) ...................................................................................................13, 16 In re iPhone Application Litig., No. 11-MD-02250-LHK, 2011 WL 4403963 (N.D. Cal. Sept. 20, 2011) .....................................23 In re Sagent Tech., Inc., 278 F. Supp. 2d 1079 (N.D. Cal. 2003) .........................................................................................23 In re Testosterone Replacement Therapy Prods. Liab. Litig., 164 F. Supp. 3d 1040 (N.D. Ill. 2016) .......................................................................................7, 11 In re Zofran (Ondansetron) Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, 2016 WL 2349105 (D. Mass. May 4, 2016) ................................11 Int’l Shoe Co. v. Washington, 326 U.S. 310 (1945) ...................................................................................................................6, 10 Interstate Nat. Gas Co. v. S. California Gas Co., 209 F.2d 380 (9th Cir. 1953) ...........................................................................................................4 Keeton v. Hustler Magazine, Inc., 465 U.S. 770 (1984) .........................................................................................................................8 King v. Nat’l Gen. Ins. Co., 129 F. Supp. 3d 925 (N.D. Cal. 2015) ...........................................................................................24 Ko v. Mut. Pharm. Co., No. C-13-00890-RMW, 2013 WL 5692375 (N.D. Cal. Oct. 18, 2013) ........................................13 Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 6 of 34 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 v DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO Kraft v. Johnson & Johnson, 97 F. Supp. 3d 846 (S.D. W. Va. 2015) ...........................................................................................7 McDaniel v. Upsher-Smith Pharms., Inc., --- F. Supp. 3d ---, 2017 WL 657778 (W.D. Tenn. Jan. 26, 2017) ............................................2, 20 McLeod v. Sandoz, Inc., No. 4:16-cv-01640-RBH, 2017 WL 1196801 (D.S.C. Mar. 31, 2017) .....................................2, 20 Milliken v. Meyer, 311 U.S. 457 (1940) .........................................................................................................................6 Moretti v. Wyeth, Inc., 579 F. App’x 563 (9th Cir. 2014) ..............................................................................................7, 13 Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013) ...................................................................................................13, 16 Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) ...................................................................................................3, 21, 22, 23 Pebble Beach Co. v. Caddy, 453 F.3d 1151 (9th Cir. 2006) .........................................................................................................6 Perdue v. Wyeth Pharms., Inc., 209 F. Supp. 3d 847 (E.D.N.C. 2016), appeal filed, No. 16-1947 (4th Cir.) ................2, 13, 16, 20 Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013) .......................................................................................................16 Perkins v. Benguet Consol. Mining Co., 342 U.S. 437 (1952) .........................................................................................................................8 Phelps v. Wyeth, Inc., 857 F. Supp. 2d 1114 (D. Or. 2012), appeal filed, No. 15-35058 (9th Cir.) .................................13 Phillips Exeter Acad. v. Howard Phillips Fund, 196 F.3d 284 (1st Cir. 1999) ....................................................................................................10, 11 PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ............................................................................................................... passim Ranza v. Nike, Inc., 793 F.3d 1059 (9th Cir. 2015) .....................................................................................................6, 8 Remick v. Manfredy, 238 F.3d 248 (3d Cir. 2001).....................................................................................................10, 11 Ruhrgas AG v, Marathon Oil Co., 526 U.S. 574 (1999) .........................................................................................................................7 Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 7 of 34 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 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO Seiferth v. Helicopteros Atuneros, Inc., 472 F.3d 266 (5th Cir. 2006) ...................................................................................................10, 11 Stephens v. Teva Pharms. U.S.A., Inc., 70 F. Supp. 3d 1246 (N.D. Ala. 2014) .................................................................................2, 13, 18 Strayhorn v. Wyeth Pharms., Inc., 737 F.3d 378 (6th Cir. 2013) .........................................................................................................22 Swartz v. KPMG LLP, 476 F.3d 756 (9th Cir. 2007) ...................................................................................................23, 24 Timmons v. Linvatec Corp., 263 F.R.D. 582 (C.D. Cal. 2010) ...................................................................................................23 Torres v. Johnson & Johnson, No. 2:14-cv-29741, 2015 WL 4888749 (S.D. W. Va. Aug. 17, 2015) ..........................................11 Tuazon v. R.J. Reynolds Tobacco Co., 433 F.3d 1163 (9th Cir. 2006) .........................................................................................................6 Walden v. Fiore, 134 S. Ct. 1115 (2014) ...................................................................................................................10 Williams v. Yamaha Motor Co., 851 F.3d 1015 (9th Cir. 2017) .....................................................................................................8, 9 RULES Fed. R. Civ. P. 8(a)(2) ......................................................................................................4, 9, 18, 22, 23 Fed. R. Civ. P. 9(b) ....................................................................................................................4, 23, 24 Fed. R. Civ. P. 12(b)(2)..........................................................................................................................1 Fed. R. Civ. P. 12(b)(6)......................................................................................................................1, 7 STATUTES AND REGULATIONS Cal. Bus. & Prof. Code §§ 17200 et seq. ...............................................................................................5 Cal. Civil Code §§ 1750 et seq. .............................................................................................................5 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. ................................................ passim 21 U.S.C. § 337(a) ...................................................................................................................15, 16, 20 21 C.F.R. § 208.24 ...................................................................................................................15, 18, 19 21 C.F.R. § 208.26 ...............................................................................................................................15 Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 8 of 34 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 vii DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO 21 C.F.R. § 314.70(b)(2)(i) ..................................................................................................................22 21 C.F.R. § 314.150(b)(10) ..................................................................................................................12 OTHER AUTHORITIES Pet. for Writ of Certiorari, Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 2016 WL 5904964 (U.S. Oct. 7, 2016) .........................................................12 Prescription Drug Product Labeling; Medication Guide Requirements, 63 Fed. Reg. 66378 (Dec. 1, 1998) .....................................................................................................................18 U.S. CONST. amend. XIV .................................................................................................................7, 10 Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 9 of 34 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 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO MOTION TO DISMISS TO THE CLERK OF COURT, ALL PARTIES, AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE THAT on July 19, 2017, at 2:00 p.m., or as soon thereafter as counsel may be heard before the Honorable William H. Orrick, in Courtroom 2, 17th Floor, of the above-entitled Court, located at 450 Golden Gate Avenue, San Francisco, California 94102, Defendant UPSHER-SMITH LABORATORIES, INC. will and hereby does move for an order dismissing Plaintiffs’ First Amended Complaint as it pertains to Upsher-Smith. Pursuant to Fed. R. Civ. P. 12(b)(2) and (6), Upsher-Smith requests that the Court dismiss Plaintiffs’ causes of action against Upsher-Smith for lack of personal jurisdiction and failure to state a claim. The grounds for Upsher-Smith’s motion to dismiss are more fully set forth in the accompanying memorandum of points and authorities. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 10 of 34 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 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO MEMORANDUM OF POINTS AND AUTHORITIES INTRODUCTION AND SUMMARY OF ARGUMENT This action involves 62 plaintiffs-39 individuals (and their spouses) who allege personal injury from the use of amiodarone, an FDA-approved, antiarrhythmic medication. 1 Plaintiffs hail from 17 different states and only six of the 62 plaintiffs live in California (three injured plaintiffs and their spouses). Plaintiffs have sued ten manufacturers of amiodarone, including Upsher-Smith, and an alleged distributor of amiodarone. Only two plaintiffs allege injury from using Upsher-Smith’s amiodarone: Phyllis Bennett and Robert Smith, neither of whom resides in California. The First Amended Complaint (“Amended Complaint”) purports to assert claims that sound in strict liability, negligence, and fraud, along with violations of California’s Unfair Competition Law and Consumers Legal Remedies Act. On their face, however, Plaintiffs’ claims do not withstand scrutiny and should be dismissed. Not only does the Amended Complaint fail to plead facts supporting the exercise of personal jurisdiction over Upsher-Smith, but other district courts recently have dismissed substantially similar claims against Upsher-Smith and other generic amiodarone manufacturers brought by this same plaintiffs’ counsel, on federal preemption grounds, among others. See, e.g., McLeod v. Sandoz, Inc., No. 4:16-cv-01640-RBH, 2017 WL 1196801 (D.S.C. Mar. 31, 2017); McDaniel v. Upsher-Smith Pharms., Inc., --- F. Supp. 3d ----, 2017 WL 657778 (W.D. Tenn. Jan. 26, 2017); Elliott v. Sandoz, Inc., No. 2:16-cv-00861-RDP, 2016 WL 4398407 (N.D. Ala. Aug. 18, 2016), appeal dismissed, No. 16-16529-FF (11th Cir. Jan. 5, 2017); Perdue v. Wyeth Pharms., Inc., 209 F. Supp. 3d 847 (E.D.N.C. 2016), appeal filed, No. 16-1947 (4th Cir.); Dreher v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 WL 3948961 (N.D. Ala. June 29, 2015); Stephens v. Teva Pharms. U.S.A., Inc., 70 F. Supp. 3d 1246 (N.D. Ala. 2014); Connolly v. Sandoz Pharms. Corp., No. 2:14-cv-152-WCO, 2014 WL 12480025 (N.D. Ga. Dec. 23, 2014). Plaintiffs’ claims against Upsher-Smith should be dismissed for several reasons. First, the Court lacks general personal jurisdiction because Upsher-Smith neither is incorporated in California, nor has its principal place of business in California. Moreover, the Court lacks specific personal jurisdiction because Plaintiffs have not pleaded that any of the California 1 Five of the plaintiffs bring claims on behalf of deceased family members. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 11 of 34 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 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO plaintiffs used Upsher-Smith’s amiodarone, nor have they pleaded any other facts showing that their claims against Upsher-Smith arise from Upsher-Smith’s purported contacts with California. Second, Plaintiffs’ claim that Upsher-Smith failed to provide adequate warnings regarding the use of its generic amiodarone is squarely preempted under the United States Supreme Court’s decision in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and the overwhelming weight of authorities post-Mensing, including the Ninth Circuit, holding that federal law requires the labeling for generic drugs to match the labeling of the innovator drugs on which they are based. Third, Plaintiffs’ assertion that they never received the FDA-approved medication guide with their amiodarone prescriptions fails as a matter of law because: (1) Upsher-Smith’s obligations regarding distribution of the medication guide exist only under the federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301, et seq., which does not provide a private right of action, so such a claim is impliedly preempted under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), as an impermissible attempt to enforce the FDCA; (2) Plaintiffs have not plausibly alleged that the distributor to whom Upsher-Smith allegedly failed to provide medication guides was the distributor of the amiodarone allegedly purchased by Mr. Bennett and Mr. Smith; and (3) Plaintiffs have not plausibly alleged that Upsher-Smith failed to comply with the medication guide regulations. Fourth, Plaintiffs’ claims of “off-label” promotion to use amiodarone to treat conditions other than those approved by FDA, like the medication guide claims, are impliedly preempted under Buckman because private litigants cannot enforce FDA regulations. Even if the claims were not preempted, Plaintiffs’ allegations are conclusory. The Amended Complaint lacks any information regarding the time, manner, and substance of any alleged representations by Upsher-Smith, or any information that Plaintiffs’ prescribing physicians ever received - let alone relied upon - any such representations. Fifth, Plaintiffs’ allegations that Upsher-Smith should have “designed” its generic amiodarone differently fail because they necessarily attack the safety of amiodarone as formulated by the brand-name manufacturer and approved by FDA. Such claims are preempted under Mensing and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), because the “sameness” Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 12 of 34 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 4 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO requirement that prohibits generic manufacturers from independently changing product labeling also prohibits them from altering the design or formulation of the generic drug. Finally, even if they were not preempted, Plaintiffs’ allegations fail to satisfy Rules 8 and 9(b) of the Federal Rules of Civil Procedure because the Amended Complaint lacks factual support, improperly lumps the defendants together without specifying the alleged wrongful conduct of each defendant, and fails to identify any specific instances of fraudulent conduct by Upsher-Smith, including the “who, what, when, where, and how” of any purported fraud. For these reasons, Plaintiffs’ Amended Complaint should be dismissed as it pertains to Upsher-Smith. STATEMENT OF FACTS Plaintiffs allege that they (or their spouses) ingested amiodarone manufactured and sold by one or more of the following: Wyeth Pharmaceuticals, Inc., Sandoz, Inc., Eon Labs, Inc., Teva Pharmaceuticals USA, Inc., Par Pharmaceutical Companies, Inc., Zydus Pharmaceuticals USA, Inc., Taro Pharmaceuticals USA, Inc., Barr Pharmaceuticals, Inc., Mayne Pharma, Inc., and Upsher-Smith (collectively, the “Pharmaceutical Defendants”), and distributed by Defendant McKesson Corporation (collectively, “Defendants”). Upsher-Smith manufactures and sells generic amiodarone. 2 Only two plaintiffs allege that they (or their spouse) used amiodarone manufactured and sold by Upsher-Smith: Phyllis Bennett (Am. Compl. ¶ 3(c)), a Georgia resident, and Robert Smith (id. ¶ 19(c)), a North Carolina resident. The other plaintiffs allege either that they used amiodarone 2 Plaintiffs acknowledge that Upsher-Smith’s amiodarone is a generic drug. Am. Compl. ¶¶ 3(d), 19(d). Though it has a different name, Pacerone ® is a generic version of amiodarone that was approved by FDA in 1998 following Upsher-Smith’s submission of an Abbreviated New Drug Application (“ANDA”). See Search of “Pacerone,” Drugs@FDA: FDA Approved Drug Products, https://www.accessdata.fda.gov/scripts/cder/daf/ (last visited May 17, 2017). This Court may take judicial notice of records on FDA’s website. Interstate Nat. Gas Co. v. S. California Gas Co., 209 F.2d 380, 385 (9th Cir. 1953) (A court may take judicial notice of “records and reports of administrative bodies.”); Anderson v. Jamba Juice Co., 888 F. Supp. 2d 1000, 1003 (N.D. Cal. 2012) (taking judicial notice of FDA guidance document from FDA website); Gustavson v. Wrigley Sales Co., 961 F. Supp. 2d 1100, 1113 n.1 (N.D. Cal. 2013) (taking judicial notice of FDA documents available on FDA’s website). Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 13 of 34 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 5 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO manufactured by other Pharmaceutical Defendants, or they fail to identify the particular manufacturer(s) of the amiodarone they ingested. 3 Plaintiffs claim that their physicians prescribed amiodarone “off-label” to treat atrial fibrillation, or other heart conditions, and, as a result, they experienced pulmonary injury or other injuries. According to Plaintiffs, they were unaware FDA had not approved amiodarone for the treatment of atrial fibrillation and they did not receive the medication guide FDA requires to be distributed to patients with amiodarone prescriptions that would have warned them of these serious risks. Plaintiffs allege they failed to receive the medication guide from their pharmacists because either the Pharmaceutical Defendants did not provide medication guides to McKesson for distribution with the amiodarone, or McKesson did not provide the medication guides to their pharmacists. The Amended Complaint purports to assert eight causes of action: (1) Strict Products Liability - Failure to Warn; (2) Negligence - Failure to Warn; (3) Negligence - Marketing and Sale; (4) Negligence Per Se; (5) Fraud and Deceit; (6) Violation of Cal. Bus. & Prof. Code §§ 17200 et. seq; (7) Violation of Cal. Civil Code §§ 1750 et seq.; and (8) Wrongful Death. STANDARD OF REVIEW I. Lack of Personal Jurisdiction Plaintiffs have the burden of establishing that jurisdiction is proper. Boschetto v. Hansing, 539 F.3d 1011, 1015 (9th Cir. 2008). In opposing a defendant’s motion to dismiss for lack of personal jurisdiction, the plaintiff must make a prima facie showing that the exercise of jurisdiction is proper by demonstrating “facts that if true would support jurisdiction over the defendant.” See Ballard v. Savage, 65 F.3d 1495, 1498 (9th Cir. 1995) (citations omitted). 3 Plaintiffs’ failure to identify which manufacturers’ products they purchased is unacceptable in light of the access they have to their own pharmacy records. The pharmacy records contain National Drug Codes that identify the manufacturer of each drug dispensed. These National Drug Codes are publicly available on FDA’s website. See National Drug Code Directory, https://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm (last visited May 16, 2017). Further, Plaintiffs’ counsel has previously identified amiodarone manufacturers by reference to these codes. See section VI, infra. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 14 of 34 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 6 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO California’s long-arm statute is coextensive with federal due process requirements, so the jurisdictional analyses under state law and federal due process are the same. Pebble Beach Co. v. Caddy, 453 F.3d 1151, 1155 (9th Cir. 2006). The constitutional due process inquiry for exercising personal jurisdiction “requires that the defendant ‘have certain minimum contacts’ with the forum state ‘such that the maintenance of the suit does not offend ‘traditional notions of fair play and substantial justice.’” Ranza v. Nike, Inc., 793 F.3d 1059, 1068 (9th Cir. 2015) (quoting Int’l Shoe Co. v. Washington, 326 U.S. 310, 316 (1945) (quoting Milliken v. Meyer, 311 U.S. 457, 463 (1940))). The strength of the contacts required depends on whether the plaintiff invokes general jurisdiction or specific jurisdiction. Ranza, 793 F.3d at 1068. The Court may exercise general jurisdiction over a non-resident defendant if the defendant has “substantial” or “continuous and systematic” contacts with California. See Tuazon v. R.J. Reynolds Tobacco Co., 433 F.3d 1163, 1171 (9th Cir. 2006) (citation omitted). General jurisdiction over a non-resident defendant may be asserted only when the non-resident defendant’s “affiliations with the State are so ‘continuous and systematic’ as to render them essentially at home in the forum state.” Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 919 (2011) (emphasis added). Specific jurisdiction, on the other hand, exists only when the defendant has purposefully availed itself of the privilege of conducting activities within the state and plaintiff’s cause of action arises out of the defendant’s contacts within the forum. Helicopteros Nacionales de Columbia, S.A. v. Hall, 466 U.S. 408, 416 (1984). Even if these conditions are met, the Court still must determine whether the exercise of jurisdiction offends “traditional notions of fair play and substantial justice.” Asahi Metal Indus. Co. v. Superior Ct., 480 U.S. 102, 113 (1987). II. Failure to State a Claim To survive a 12(b)(6) motion, a complaint must allege facts setting forth a plausible claim for relief. Ashcroft v. Iqbal, 556 U.S. 662, 678-79 (2009); Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). Labels, conclusions, and recitations of a claim’s legal elements are not “facts.” Iqbal, 556 U.S. at 678-79; Twombly, 550 U.S. at 555. Further, it is not enough to allege facts “merely consistent with” liability or showing only that entitlement to relief is possible. Iqbal, 556 U.S. at Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 15 of 34 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 7 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO 678; Twombly, 550 U.S. at 557. Unless the complaint pleads sufficient facts to cross the line “from conceivable to plausible,” it must be dismissed. Twombly, 550 U.S. at 570. The federal pleading standard “demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Iqbal, 556 U.S. at 678. “Determining whether a complaint states a plausible claim for relief [is] … a context-specific task that requires the reviewing court to draw on its judicial experience and common sense.” Id. at 679. Even if a complaint does state a claim for relief, it should be dismissed for failure to state a claim if the allegations in the complaint establish an affirmative defense. Federal preemption is a question of law and thus may be determined by this Court on a Rule 12(b)(6) motion to dismiss. See Moretti v. Wyeth, Inc., 579 F. App’x 563, 565-66 (9th Cir. 2014). ARGUMENT I. Plaintiffs’ Claims Against Upsher-Smith Should Be Dismissed for Lack of Personal Jurisdiction Plaintiffs’ Amended Complaint does not support a finding of personal jurisdiction over Upsher-Smith. Plaintiffs cannot establish that Upsher-Smith has sufficient contacts with California to establish either general or specific jurisdiction. 4 A. The Court lacks general jurisdiction over Upsher-Smith. This Court lacks general jurisdiction over Upsher-Smith, which is not incorporated in California and does not have its principal place of business here. A court’s exercise of jurisdiction over a defendant exposes the defendant “to the State’s coercive power, and is therefore subject to review for compatibility with the Fourteenth Amendment’s Due Process Clause.” Goodyear, 564 U.S. at 918. In this way, the Due Process Clause under the Fourteenth Amendment “sets the outer boundaries of a state tribunal’s authority to proceed against a defendant.” Id. at 923. 4 Should Plaintiffs file a motion to remand in this matter, the Court may nevertheless decide the question of personal jurisdiction first. Ruhrgas AG v, Marathon Oil Co., 526 U.S. 574, 588 (1999) (holding that a court may determine whether it has personal jurisdiction over a party before proceeding to determine whether it has subject-matter jurisdiction); In re Testosterone Replacement Therapy Prods. Liab. Litig., 164 F. Supp. 3d 1040 (N.D. Ill. 2016) (dismissing nonresident plaintiff’s claims for lack of personal jurisdiction over pharmaceutical manufacturer defendants in Missouri and denying plaintiff’s motion to remand); Kraft v. Johnson & Johnson, 97 F. Supp. 3d 846, 851 (S.D. W. Va. 2015) (considering “straightforward” personal jurisdiction inquiry before more complicated question of subject-matter jurisdiction). Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 16 of 34 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 8 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO In Daimler AG v. Bauman, the Supreme Court clarified the standard for a court to exercise general jurisdiction over a corporation. It held that the Due Process Clause limits the exercise of general jurisdiction over non-resident corporations to instances where the defendant’s “affiliations with the [forum] state are so ‘continuous and systematic’ as to render [it] essentially at home in the forum state.” 134 S. Ct. 746, 761 (2014) (quoting Goodyear, 564 U.S. at 919). According to the Supreme Court, “[t]he paradigmatic locations where general jurisdiction is appropriate over a corporation are its place of incorporation and its principal place of business.” Ranza, 793 F.3d at 1069 (citing Daimler, 134 S. Ct. at 760). Only in an “exceptional case” is general jurisdiction available elsewhere. Daimler, 134 S. Ct. at 761 n.19. 5 Plaintiffs have not alleged any basis on which to exercise general jurisdiction over Upsher- Smith. It is undisputed that Upsher-Smith is a Minnesota corporation with its principal place of business in Minnesota. See Am. Compl. ¶ 47. Accordingly, under Daimler, Upsher-Smith is at home in Minnesota, not California. Therefore, the Court lacks general jurisdiction over Upsher-Smith. B. The Court lacks specific jurisdiction over Upsher-Smith because Plaintiffs have not pleaded facts showing that their claims arise from Upsher-Smith’s California contacts. Plaintiffs’ Amended Complaint does not support a finding that any of the 62 Plaintiffs’ claims arise from Upsher-Smith’s contacts with California. As a result, this Court does not have specific jurisdiction over Upsher-Smith. A court may exercise specific jurisdiction over a foreign defendant if “the defendant’s suit- related conduct … create[s] a substantial connection with the forum State.” Williams v. Yamaha Motor Co., 851 F.3d 1015, 1022-23 (9th Cir. 2017). Under the Ninth Circuit’s jurisdictional 5 In Daimler, the Supreme Court identified only one exceptional case, Perkins v. Benguet Consol. Mining Co., 342 U.S. 437, 448 (1952). In Perkins, the Supreme Court held that Ohio courts had general jurisdiction over a non-resident Philippine corporation even though the corporation was incorporated in the Philippines and had its principal place of business there. The Philippine corporation’s president was forced to conduct business in Ohio because Japanese wartime occupation of the Philippines halted all company operations in the Philippines. The Supreme Court observed that because business activity in the Philippines was suspended, “Ohio was the corporation’s principal, if temporary, place of business.” Daimler, 134 S. Ct. at 756 (citing Keeton v. Hustler Magazine, Inc., 465 U.S. 770, 780, n.11 (1984)). The Court also noted that these bases have the benefit of identifying “unique” and “easily ascertainable” forums that provide plaintiffs with “one clear and certain forum in which a corporate defendant may be sued.” Daimler, 134 S. Ct. at 760. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 17 of 34 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 9 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO analysis, specific jurisdiction over a non-resident defendant is proper only if three requirements are satisfied: “(1) the defendant either ‘purposefully direct[s]’ its activities or ‘purposefully avails’ itself of the benefits afforded by the forum’s laws; (2) the claim “arises out of or relates to the defendant’s forum-related activities; and (3) the exercise of jurisdiction [ ] comport[s] with fair play and substantial justice, i.e., it [is] reasonable.” Id. (citation omitted) (emphasis added). This Court lacks specific jurisdiction over Upsher-Smith because the complaint fails to plead facts showing that any of Plaintiffs’ claims “arise out of” or “relate to” any activities of Upsher- Smith in California. The Amended Complaint is devoid of any allegations connecting Plaintiffs’ claims with Upsher-Smith’s purported business activities in California. Only six of the 62 Plaintiffs are residents of California (Edwin and Margaret Streed, Ray and Maire Hubler, and Noah and Karen Medford (see Am. Compl. ¶¶ 1, 15, 16), and none of these California plaintiffs alleges use of Upsher-Smith’s amiodarone. See id. ¶ 1(c) (listing all the defendant manufacturers using the ambiguous conjunction “and/or” and thus failing to allege use of any specific defendant’s product); ¶ 15(c), ¶ 16(c) (alleging use of amiodarone “manufactured by one or more of the Generic Defendants”). 6 These vague allegations are insufficient to identify Upsher-Smith, or any other defendant, as the manufacturer of the amiodarone these plaintiffs used. See Iqbal, 556 U.S. at 678 (“The plausibility standard … asks for more than a sheer possibility that a defendant has acted unlawfully.”); Adams v. I-Flow Corp., No. CV09-09550, 2010 WL 1339948, at *3 (C.D. Cal. Mar. 30, 2010) (finding in a multi-plaintiff, multi-defendant case that each“ plaintiff must allege the identity of the particular defendant who manufactured the pain pump and the particular defendant who manufactured the anesthetic that allegedly injured plaintiff”); Gauvin v. Trombatore, 682 F. Supp. 1067, 1071 (N.D. Cal. 1988) (lumping multiple defendants in one broad allegation fails to satisfy Rule 8(a) notice requirement). Absent well-pleaded allegations that at least one of the California plaintiffs used Upsher-Smith’s amiodarone, or some other factual basis connecting 6 Plaintiffs allege only their states of residence, not where they obtained amiodarone, or where the alleged injuries occurred. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 18 of 34 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 10 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO Plaintiffs’ claims to Upsher-Smith’s purported contacts with California, the Court lacks specific jurisdiction over Upsher-Smith. 7 But even if a California plaintiff had sufficiently alleged use of Upsher-Smith’s amiodarone, the Court would still lack specific jurisdiction over Upsher-Smith with regard to the claims of all the other plaintiffs, including the claims of the 56 out-of-state plaintiffs. Indeed, the only two plaintiffs that allege use of Upsher-Smith’s amiodarone are non-California residents. The doctrine of specific jurisdiction permits a court to exercise jurisdiction “where a corporation’s in-state activities are not only “continuous and systematic, but also give rise to the liabilities sued on.” Daimler, 134 S. Ct. at 761 (quoting Int’l Shoe, 326 U.S. at 317) (emphasis added). Plaintiffs do not allege that any of the out-of-state plaintiffs ingested amiodarone in California, was injured in California, was injured by conduct that occurred in California, or that their claims have any connection at all to California. Nor can Plaintiffs “piggy-back” the claims of the out-of-state plaintiffs onto the claims of a California plaintiff. “Due process requires that a defendant be haled into court in a forum state based on his own affiliation with the State, not based on the ‘random, fortuitous, or attenuated’ contacts he makes by interacting with other persons affiliated with the State.” Walden v. Fiore, 134 S. Ct. 1115, 1122 (2014). Thus, courts have held that the specific jurisdiction analysis is both claim-specific and plaintiff-specific. See Seiferth v. Helicopteros Atuneros, Inc., 472 F.3d 266, 274-75 (5th Cir. 2006) (“Permitting the legitimate exercise of specific jurisdiction over one claim to justify the exercise of specific jurisdiction over a different claim that does not arise out of or relate to the defendant’s forum contacts would violate the Due Process Clause”); Remick v. Manfredy, 238 F.3d 248, 255 (3d Cir. 2001) (finding that the specific jurisdiction analysis is “claim specific”); Phillips Exeter Acad. v. Howard Phillips Fund, 196 F.3d 284, 289 (1st Cir. 1999) (“Questions of specific jurisdiction are always tied to the particular claims asserted.”); see also Capital Equip., Inc. v. CNH Am., LLC, 394 F. Supp. 2d 1054, 1057 (E.D. Ark. 2005) (finding that the “jurisdictional issues are severable in that personal jurisdiction must be established for the claims of each [p]laintiff against [the defendant]”); 7 Thus, the Court should disregard Plaintiffs’ boilerplate, conclusory allegation that their claims “arise in part out of the Defendants’ commercial activities within the State of California ….” Am. Compl. ¶ 57. Indeed, Plaintiffs’ jurisdictional allegation, which lumps Defendants together, is as vague as their allegations of product use. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 19 of 34 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 11 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO Arnold v. Goldstar Fin. Sys., Inc., No. 01-C-7694, 2002 WL 1941546, at *3 (N.D. Ill. Aug. 22, 2002) (finding that “[t]he personal jurisdiction analysis … must be plaintiff-specific”); Evergreen Int’l Airlines, Inc. v. Anchorage Advisors, LLC, No. 3:11-cv-1416-PK, 2012 WL 3637551, at *9 (D. Or. July 9, 2012) (concluding that “the Ninth Circuit would not recognize any form of supplemental specific personal jurisdiction”) (citing Seiferth, Remick, and Phillips). Courts have found personal jurisdiction lacking in circumstances nearly identical to those presented here, i.e., claims brought by out-of-state plaintiffs against non-resident defendants for injuries sustained in the plaintiffs’ home states. In re Zofran (Ondansetron) Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, 2016 WL 2349105, at *5 (D. Mass. May 4, 2016) (“The complaint falls far short of establishing any nexus between the non-Missouri plaintiffs’ claims and [the defendant’s] Missouri-based activities.”); Addelson v. Sanofi S.A., No. 4:16-cv-01277 ERW, 2016 WL 6216124, at *3-4 (E.D. Mo. Oct. 25, 2016) (“Plaintiffs have not alleged any facts which connect the claims of [the out-of-state plaintiff] with Defendants’ Missouri contacts.”); In re: Bard IVC Filters Prods. Liab. Litig., No. CV-16-02853-PHX-DGC, 2016 WL 6393596, at *4-6 (D. Ariz. Oct. 28, 2016) (“Because the out-of-state Plaintiffs received their Bard filters and related medical care in other States, they cannot individually show that their injuries arise out of or relate to Defendants’ Missouri activities.”); Torres v. Johnson & Johnson, No. 2:14-cv-29741, 2015 WL 4888749, at *5 n.5 (S.D. W. Va. Aug. 17, 2015) (holding that “[t]he finding of specific jurisdiction over the claims of the four New Mexico plaintiffs … does not support a finding of personal jurisdiction over the claims of the out-of-state defendants, whose claims have no nexus to the forum”); In re Testosterone Replacement Therapy Prods. Liab. Litig., 164 F. Supp. 3d 1040, 1047-49 (N.D. Ill. 2016); see also Glater v. Eli Lilly & Co., 744 F.2d 213, 216 (1st Cir. 1984) (holding that New Hampshire court lacked specific jurisdiction over the plaintiff’s claim for injuries from a drug “purchased and consumed in Massachusetts,” and rejecting argument that the court could rely on alleged unrelated sales of drug in New Hampshire because claim “did not arise from Lilly’s New Hampshire activities”); Cahen v. Toyota Motor Corp., 147 F. Supp. 3d 955, 962 (N.D. Cal. 2015), appeal filed, No. 16-15496 (9th Cir.) (“[T]he Ford plaintiffs bring solely Oregon and Washington causes of action stemming from transactions that occurred in those states. They have failed to demonstrate that Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 20 of 34 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 12 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO specific jurisdiction over Ford is appropriate in California.”); Carpenter v. Sikorsky Aircraft Corp., 101 F. Supp. 3d 911, 923 (C.D. Cal. 2015) (“Plaintiffs have not alleged or offered evidence as to any contact with the state of California that is related to the Helicopter or the crash in Georgia.”). In sum, Plaintiffs’ Amended Complaint fails to allege any connection between Plaintiffs’ claims and any activities of Upsher-Smith in California. Accordingly, the Court should dismiss Plaintiffs’ claims against Upsher-Smith for lack of specific jurisdiction. 8 II. Plaintiffs’ Inadequate Warnings Claims Are Preempted. Plaintiffs’ claims based on the warnings for amiodarone are preempted under the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). In Mensing, the plaintiffs alleged that the manufacturers of the generic drug they took failed to provide adequate warnings. The manufacturers argued that federal law required them to provide the same warnings as the brand- name drug. As such, the manufacturers asserted, it was impossible for them to comply with both federal law and any state-law duty requiring them to provide different warnings. The Court agreed and held the plaintiffs’ claims were preempted: If the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law. Taking [the plaintiffs’] allegations as true, state law imposed on the Manufacturers a duty to attach a safer label to their generic metoclopramide. Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels. See, e.g., 21 CFR § 314.150(b)(10). Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same. Id. at 618. 8 The United States Supreme Court recently heard oral argument in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty. No. 16-466 (U.S. argued Apr. 25, 2017). In Bristol-Myers Squibb Co., 661 plaintiffs were joined in a single, California state court action, claiming they had been injured by ingesting Plavix, a pharmaceutical drug. Pet. for Writ of Certiorari, Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., No. 16- 466, 2016 WL 5904964, at *5 (U.S. Oct. 7, 2016). Only 86 of the 661 plaintiffs lived in California, and the remaining 575 plaintiffs neither lived in California nor sustained any injury there. Id. Moreover, Bristol-Myers Squibb (“BMS”) was neither incorporated nor headquartered in California and none of the Plavix at issue was manufactured in California. Bristol-Myers Squibb Co. v. Superior Court, 377 P.3d 874, 877-78 (Cal. 2016). Notwithstanding these facts, the California Supreme Court held that it had specific personal jurisdiction over BMS as to all of the plaintiffs’ claims. A decision in Bristol-Myers is expected soon. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 21 of 34 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 13 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO Since Mensing, courts have consistently held that cases against generic drug manufacturers based on allegations of failure to warn do not survive federal preemption. The Ninth Circuit and its district courts have repeatedly held that such claims are preempted, regardless of the legal theory alleged. See Moretti v. Wyeth, Inc., 579 F. App’x 563, 565-66 (9th Cir. 2014) (affirming dismissal of failure-to-warn claims); Gaeta v. Perrigo Pharm. Co., 469 F. App’x 556 (9th Cir. 2012), aff’g, 562 F. Supp. 2d 1091 (N.D. Cal. 2008) (affirming dismissal of negligence and breach of warranty claims); Ko v. Mut. Pharm. Co., No. C-13-00890-RMW, 2013 WL 5692375, at *2 (N.D. Cal. Oct. 18, 2013) (dismissing claims for strict liability, negligence, breach of warranty, and unfair competition); Phelps v. Wyeth, Inc., 857 F. Supp. 2d 1114, 1123-24, 1132 (D. Or. 2012), appeal filed, No. 15-35058 (9th Cir.) (dismissing claims for negligence, strict liability, breach of warranty, misrepresentation, and fraud). 9 Courts have recently found nearly identical wrongful death claims involving amiodarone preempted by Mensing. See, e.g., Perdue, 209 F. Supp. 3d at 850 (“These claims against the generic defendants premised upon failure to provide adequate warnings accompanying the sale and distribution of amiodarone … are preempted by federal law.”); Dreher, 2015 WL 3948961, at *4 (“Mensing squarely precludes any suit against the Generic Defendants based on the alleged inadequacy of amiodarone’s warnings”); Stephens, 70 F. Supp. 3d at 1250-51; Connolly, 2014 WL 12480025, at *3-6. These authorities warrant a finding of preemption here. Plaintiffs challenge the adequacy of the warnings provided in the amiodarone labeling, as the following examples show: • “Defendants, jointly and severally, have concealed information about catastrophic injuries and death attributable to this drug, and thousands of serious adverse 9 Other circuits are in accord. See, e.g., In re Darvocet, Darvon and Propoxyphene Prods. Liab. Litig, 756 F.3d 917, 926-36 (6th Cir. 2014) (affirming dismissal of claims alleging failure to warn, wrongful marketing, breach of warranty, misrepresentation, fraud, consumer protection, and negligence per se); Drager v. PLIVA USA, Inc., 741 F.3d 470, 475-79 (4th Cir. 2014) (affirming dismissal of fraudulent concealment, misrepresentation, strict liability, negligence, and warranty claims); Guarino v. Wyeth LLC, 719 F.3d 1245 (11th Cir. 2013) (affirming dismissal of claims alleging negligence, strict liability, breach of warranty, misrepresentations, fraud, and negligence per se); Fullington v. Pfizer, Inc., 720 F.3d 739, 744-45 (8th Cir. 2013) (affirming dismissal of negligence, strict liability, misrepresentation, and fraud claims); Morris v. PLIVA, Inc., 713 F.3d 774, 776-77 (5th Cir. 2013) (affirming dismissal of failure-to-warn and warranty claims). Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 22 of 34 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 14 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO medical events in their exclusive possession from the FDA, health care professionals, and consumers, including Plaintiffs.” Am. Compl. ¶ 91; • “[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 ….” Id. ¶ 100; • “Defendants failed to warn the public and Plaintiffs of material facts regarding the safety and efficacy of Cordarone®/Amiodarone ….” Id. ¶ 101; • “[T]he Cordarone®/Amiodarone manufactured, distributed, and/or supplied by Defendants was defective due to inadequate post-marketing warning and instruction ….” Id. ¶ 104; • “Defendant Wyeth and the Generic Defendants have engaged in a calculated and coordinated campaign of silence despite their knowledge of the growing public acceptance of misinformation and misrepresentations regarding both the safety and efficacy of the use of Cordarone®/Amiodarone ….” Id. ¶ 31. As Mensing and its progeny make clear, federal law required Upsher-Smith to provide warnings for its generic amiodarone that were the same as the warnings for the brand-name drug, Cordarone ® . Because Upsher-Smith could not simultaneously comply with a state-law duty to modify the warnings and the federal requirement to keep the same warnings as the brand-name drug, Plaintiffs’ state-law claims directly conflict with federal law and are, therefore, preempted. Accordingly, to the extent Plaintiffs challenge the content of the amiodarone warnings, their claims must be dismissed under Mensing. 10 III. Plaintiffs’ “Medication Guide” Allegations Are Preempted and Otherwise Fail to State a Claim Plaintiff Phyllis Bennett alleges that Mr. Bennett “did not receive the required Medication Guide from his pharmacist because the Medication Guides were not provided by Wyeth, Upsher- Smith and Teva to McKesson and/or by McKesson to pharmacists for distribution with his prescription.” Am. Compl. ¶ 3(e). Likewise, Plaintiff Robert Smith alleges that “he did not receive 10 Anticipating Upsher-Smith’s preemption defense, Plaintiffs state that preemption should not apply here because FDA approved Wyeth’s Cordarone ® for use in the United States without “the rigorous randomized clinical trials required for FDA drug approval.” Am. Compl. ¶¶ 116-24. Plaintiffs cite no authority for the proposition that the approval process FDA followed for Cordarone ® has any bearing on the preemption analysis. Regardless of how and why FDA approved Cordarone ® , the fact remains that it was (and is) an FDA-approved prescription drug and federal law required Upsher-Smith to use the same warnings and labeling for its generic amiodarone. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 23 of 34 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 15 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO the required Medication Guide from his pharmacist because the Medication Guides were not provided by Wyeth and Upsher-Smith to McKesson and/or by McKesson to pharmacists for distribution with his prescription.” Id. ¶ 19(e). Plaintiffs Bennett and Smith further allege that Upsher-Smith and the other defendants “were responsible for ensuring that the appropriate warning labels and Medication Guide were provided to [Mr. Bennett and Mr. Smith]” and that had Mr. Bennett and Mr. Smith been provided this information, they “would not have taken amiodarone.” Id. ¶¶ 3(f), 19(f). These allegations fail to state a claim for multiple reasons. A. Plaintiffs cannot bring a private action to enforce the federal medication guide regulations. As Plaintiffs acknowledge, the distribution of medication guides is governed by federal law, not state law. See Am. Compl. ¶¶ 146, 195; 21 C.F.R. § 208.24. Federal law required only that Upsher-Smith make the medication guide available to “authorized dispensers” so they could provide it to patients: (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 [e.g., pharmacist] 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) unless an exemption applies under § 208.26. 21 C.F.R. § 208.24(b), (e) (emphasis added). Federal law expressly prohibits enforcement of FDA regulations by private individuals. 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 States.”); see Buckman Co. v. Plaintiffs’ Legal Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 24 of 34 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 16 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO Comm., 531 U.S. 341, 349 n.4 (2001) (“The 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].”) (citing 21 U.S.C. § 337(a)); Perez v. Nidek Co., 711 F.3d 1109, 1119-20 (9th Cir. 2013) (affirming dismissal of claim that “exist[s] solely by virtue of the FDCA … requirements” under Buckman as attempted private enforcement action); Anderson v. Medtronic, Inc., No. 14-cv-00615, 2015 WL 2115342, at *4 (S.D. Cal. May 6, 2015) (“Claims that exist solely by virtue of FDCA requirements are impliedly preempted by federal law.”) (citing Perez, 711 F.3d at 1119); Dunbar v. Medtronic, Inc., No. CV 14-01529-RGK, 2014 WL 3056026, at *3, 5 (C.D. Cal. June 25, 2014); Grant v. Corin Group PLC, No. 3:15-CV-169-CAB-BLM, 2016 WL 4447523, at *3, 4 (S.D. Cal. Jan. 15, 2016). 11 As a court in the Central District of California held, a state-law claim is impliedly preempted under Buckman unless it relies “on traditional state tort law which had predated the federal enactments in question.” Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1175, 1178 (C.D. Cal. 2013) (dismissing claims for violation of FDA regulations). “In other words, the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law-and that would give rise to liability under state law even if the FDCA had never been enacted.” Id. at 1175 (citation omitted) (emphasis in original). Courts have held that nearly identical claims for failure to provide an amiodarone medication guide were preempted under Buckman. Perdue, 209 F. Supp. 3d at 853 (“Because the requirement to provide a medication guide to distributors is based solely in the requirements of the FDCA and related regulations, which requirements did not exist previously under North Carolina common law, plaintiff’s claims based upon failure to provide a medication guide are preempted under Buckman.”); Dreher, 2015 WL 3948961, at *8-9 (holding that claim for failure to provide amiodarone medication guide was preempted as attempt by private litigant to enforce the FDCA); Elliott, 2016 WL 4398407, at *5-6 (same). This Court should find Plaintiffs’ claims preempted as well. 11 See also In re Darvocet, 756 F.3d at 936 (holding that statutory negligence claims against generic manufacturers based on violations of federal standards in the FDCA were preempted under Buckman because “the FDA has the exclusive power to enforce the FDCA”); Morris, 713 F.3d at 777 (“[A] claim that PLIVA breached a federal labeling obligation sounds exclusively in federal (not state) law, and is preempted.”). Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 25 of 34 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 17 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO B. Plaintiffs’ medication guide claims fail because Plaintiffs have not plausibly alleged that McKesson was the distributor of the amiodarone they ingested. Plaintiffs allege that Mr. Bennett and Mr. Smith “did not receive the required Medication Guide from [their] pharmacist[s] because the Medication Guides were not provided by Wyeth, Upsher-Smith and Teva to McKesson and/or by McKesson to pharmacists for distribution with [their] prescription ….” Am. Compl. ¶¶ 3(e), 19(e) (emphasis added). But Plaintiffs allege no facts plausibly showing that McKesson distributed the amiodarone they purchased in Georgia and North Carolina, respectively. Instead, Plaintiffs illogically (and implausibly) deduce that, “[a]s more than 1/3 of all prescription drugs purchased daily in North America were distributed by McKesson, it was the primary distributor of Amiodarone by both Wyeth and the Generic Defendants,” and allege that McKesson was “responsible for printing and distributing Medication Guides for some of if not all of the Generic Defendants.” Id. ¶¶ 50, 75, 119. Even assuming that McKesson distributes more than one-third of the prescription drugs in North America, the Amended Complaint does not plausibly allege that McKesson distributed Upsher-Smith’s amiodarone in Georgia or North Carolina, much less that McKesson distributed Upsher-Smith’s amiodarone to Mr. Bennett’s and Mr. Smith’s pharmacies, or delivered the specific amiodarone tablets that were purchased by Mr. Bennett and Mr. Smith (a pharmacy could purchase from multiple distributors). Indeed, based on Plaintiffs’ allegations, two-thirds of the prescription drugs in North America are distributed by someone other than McKesson. Thus, Plaintiffs have pled no more than the possibility that McKesson was the distributor of the amiodarone they purchased. That is insufficient to state a claim. See Iqbal, 556 U.S. at 678 (“The plausibility standard … asks for more than a sheer possibility that a defendant has acted unlawfully.”). Absent well-pleaded allegations that connect McKesson to Mr. Bennett’s and Mr. Smith’s pharmacies, Plaintiffs’ allegations that McKesson did not receive medication guides from Upsher-Smith fail to state a claim. // // // // Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 26 of 34 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 18 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO C. Plaintiffs’ medication guide claims fail because Plaintiffs have not plausibly alleged that Upsher-Smith failed to comply with the medication guide regulations. Even if the Court accepts Plaintiffs’ unsupported allegations that McKesson was the distributor of Plaintiffs’ amiodarone, Plaintiffs’ medication guide claims fail because Plaintiffs have not pleaded factual allegations sufficient for this Court to infer that Upsher-Smith failed to comply with the medication guide regulations. First, Plaintiffs allege only the possibility that Upsher-Smith failed to provide medication guides to McKesson, contending at the same time that McKesson may have failed to provide the medication guides to the pharmacies. Am. Compl. ¶¶ 3(e), 19(e). But to state a claim, Plaintiffs must plead facts that “permit the court to infer more than the mere possibility of misconduct ….” Iqbal, 556 U.S. at 679 (citing Fed. R. Civ. P. 8(a)(2)); see Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 WL 178038, at *5 (N.D. Ala. Jan. 14, 2015) (“Plaintiff’s complaint leaves open the possibility that Upsher fulfilled its duty to provide Medication Guides to the authorized distributor, but the authorized distributor simply failed to give the Medication Guide to Mr. Dreher. Thus, Plaintiff’s complaint fails to establish ‘more than a sheer possibility that [Upsher] acted unlawfully.’”) (quoting Iqbal, 556 U.S. at 678); Stephens, 70 F. Supp. 3d at 1249 (dismissing medication guide claim for same reason). Second, 21 C.F.R. § 208.24(b) states the manufacturers can fulfill their responsibility to make medication guides available for distribution to patients by, among other methods, “[p]roviding the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers ….” Id. § 208.24(b)(2) (emphasis added). In 1998, FDA explained that providing the “means to produce” can include, for example, supplying a “computer file” or providing access through “pharmacy software systems” so that pharmacies “can provide printouts of Medication Guides.” Final Rule, Prescription Drug Product Labeling; Medication Guide Requirements, 63 Fed. Reg. 66378, 66381, 66390-91 (Dec. 1, 1998). The regulation is intended “[t]o allow for flexibility” and intentionally does not limit or “specify the means” of distribution. Id. at 66391. While Plaintiffs allege that “the Medication Guides were not provided by … Upsher-Smith … to McKesson [the alleged distributor],” (Am. Compl. ¶¶ 3(e), 19(e)), critically, they do not allege that their pharmacies were without the “means to produce” them and, specifically, the ability to print Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 27 of 34 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 19 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO the medication guide from a computer. A complaint alleging that the defendant failed to comply with only one of multiple methods for satisfying a regulatory obligation does not state a claim. See Iqbal, 556 U.S. at 678 (“A claim [lacks] facial plausibility when the plaintiff [fails to] plead[] factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.”). Accordingly, Plaintiffs have not pleaded sufficient facts to state a claim for failure to comply with 21 C.F.R. § 208.24(b). For all these reasons, Plaintiffs’ medication guide allegations fail as a matter of law. 12 IV. Plaintiffs’ Allegations of “Off-Label” Promotion Are Preempted and Otherwise Fail to State a Claim Plaintiffs’ allegations of “off-label” promotion are similarly preempted and fail to state a claim. Plaintiffs allege that Mr. Bennett and Mr. Smith were prescribed amiodarone by their physicians to treat atrial fibrillation, an “off-label” use (i.e., a use not approved by FDA), “as a result of the long term and pervasive promotional activities of brand innovator Defendant Wyeth to an entire generation of physicians …, along with the continuing sales efforts of Defendant Upsher- Smith [and, as to Mr. Bennett,] Teva ….” Am. Compl. ¶¶ 3(d), 19(d). Plaintiffs further allege that “Wyeth and the Generic Defendants simultaneously engaged in a massive and illegal marketing and promotional scheme in which they aggressively and illegally promoted Cordarone®/Amiodarone for uses never authorized by the FDA,” which “violates FDA regulations.” Id. ¶ 69 (discussing the specific regulatory provisions governing the dissemination of information on off-label uses), ¶ 126; see id. ¶¶ 3(c), 19(c), 126, 132, 165. To the extent Plaintiffs assert that the “alleged promotion resulted in failure to properly warn,” the claim is “preempted by federal law” under Mensing. Connolly, 2014 WL 12480025, at 12 Though contrary to Plaintiffs’ allegations that the medication guide warned of the “serious, potentially life-threatening side effects” Mr. Bennett and Mr. Smith experienced, Plaintiffs allege that the current warnings and labeling for amiodarone are inadequate to warn of the drug’s risks. See Am. Compl. ¶¶ 3(f), 19(f) (“In addition to not receiving the Medication Guide, he was not provided up to date warning labels that would have warned him of the serious, potentially life-threatening, side-effects of Amiodarone.”); ¶ 121 (“the Cordarone®/Amiodarone, manufactured and/or supplied by Defendants was and is unaccompanied by proper warnings”) (emphasis added). Any claim that Upsher-Smith should have provided different warnings in the medication guide or in the physician labeling for amiodarone is preempted under Mensing. See section II, supra. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 28 of 34 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 20 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO *6. Moreover, this claim is preempted for the same reason as the medication guide claim: Buckman bars private enforcement of the FDCA. As the court held in Dunbar v. Medtronic, Inc., [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 [21 U.S.C.] § 337(a). Therefore, Plaintiffs’ negligence claim based on off-label promotion is impliedly preempted. Dunbar, 2014 WL 3056026, at *5; see also Houston, 957 F. Supp. 2d at 1178 (finding “any negligence claim based solely on illegal off-label promotion is impliedly preempted under Buckman and § 337(a)”); Anderson, 2015 WL 2115342, at *6 (“[T]here would be no such thing as off-label promotion without the federal statutory scheme. … 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.”); Goldsmith v. Allergan, Inc., No. CV 09-7088, 2011 WL 147714, at *2-3, 7-8 (C.D. Cal. Jan. 13, 2011) (dismissing claim based on off-label marketing as attempt to privately enforce the FDCA). Other district courts have dismissed nearly identical claims for off-label promotion in cases involving amiodarone filed by the same counsel representing Plaintiffs here. See, e.g., Perdue, 209 F. Supp. 3d at 851-52 (“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…. Thus, because plaintiff’s claim exists solely by virtue of the FDCA regulations regarding off-label promotion, and because such regulations do not have a parallel in North Carolina law, plaintiff’s claims based upon off-label promotion are preempted.”); McDaniel, 2017 WL 657778, at *5 (“As the concept of ‘off-label’ is entirely federal, Plaintiff’s claims would not exist in the absence of the FDCA and are therefore impliedly preempted under Buckman.”); McLeod, 2017 WL 1196801, at *6-7 (same). Accordingly, Plaintiffs’ claims for off-label promotion are barred as a matter of law. Even if these allegations were not preempted, Plaintiffs have failed to state a claim for relief. The Amended Complaint lumps the defendants together in vague, generalized accusations, none of Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 29 of 34 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 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO which identifies any instance of off-label promotion by Upsher-Smith. See, e.g., Am. Compl. ¶¶ 69, 118, 126, 132, 165. For example, Plaintiffs attempt to hide the lack of specific factual support for their claims against Upsher-Smith (and everyone else) by broadly asserting that “Wyeth and the Generic Defendants” collectively “engaged in a massive and illegal marketing and promotional scheme in which they aggressively and illegally promoted Cordarone®/Amiodarone for uses never authorized by the FDA.” Id. ¶ 126. Plaintiff Bennett pleads only that Mr. Bennett “consumed … the Amiodarone manufactured by Upsher-Smith, and Teva and potentially other Generic Defendants, and actively promoted for “off-label” use by them ….” Id. ¶ 3(c). Similarly, Plaintiff Smith pleads only that he “consumed … the Amiodarone manufactured by Upsher-Smith and potentially other Generic Defendants and actively promoted for “off-label” use by them ….” Id. ¶ 19(c). These conclusory allegations do not state a claim. Moreover, Plaintiffs then essentially contradict these conclusory allegations by speculating that Mr. Bennett’s and Mr. Smith’s physicians “w[ere] apparently a victim of Defendant Wyeth’s long term and successful brand innovator promotional efforts,” and alleging that the Generic Defendants “failed to disclose the details and dangers of Amiodarone toxicity related to [off-label] use ….” Id. ¶¶ 3(d), 19(d) (emphasis added). Such failure-to-warn allegations against the Generic Defendants clearly are preempted by Mensing. Plaintiffs not only fail to identify a single instance of alleged off-label promotion by Upsher- Smith, but they also fail to connect any such promotion to Mr. Bennett’s and Mr. Smith’s amiodarone prescriptions. Indeed, Plaintiffs fail to plead any facts showing that Mr. Bennett’s and Mr. Smith’s physicians received, saw, or heard any alleged off-label promotion from anyone, much less Upsher-Smith, or that Mr. Bennett’s and Mr. Smith’s physicians chose to prescribe amiodarone to treat their atrial fibrillation in reliance on such information. 13 For these reasons, Plaintiffs’ claims based on off-label promotion should be dismissed. // // 13 Plaintiffs appear to be bringing claims of off-label promotion simply because Mr. Bennett and Mr. Smith were prescribed amiodarone for an off-label use. But physicians routinely prescribe drugs for off-label uses. See Buckman, 531 U.S. at 351 n.5 (“Off-label use is widespread in the medical community and often is essential to giving patients optimal medical care, both of which medical ethics, FDA, and most courts recognize”) (citation omitted). Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 30 of 34 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 22 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO V. Plaintiffs’ Product Defect Allegations Do Not State a Claim Plaintiffs also make passing references to amiodarone having certain unspecified “defects” and assert amiodarone was “unreasonably dangerous as it was packaged, marketed, designed, manufactured, and sold.” Am. Compl. ¶¶ 142, 145. Any claim of design defect is preempted under the Supreme Court’s ruling in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013). In Bartlett, the Supreme Court reaffirmed Mensing in barring claims that a generic drug was defectively designed. The plaintiff’s claims of design defect under New Hampshire law required the defendant to change either the drug’s labeling or its design. Id. at 2466. “As [Mensing] made clear, federal law prevents generic drug manufacturers from changing their labels.” Id. at 2476 (citing Mensing, 131 S. Ct. at 2577). The Court found that federal law equally prohibits changes to a generic drug’s design: “[T]he FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based.” Id. at 2475. Further, “[o]nce a drug-whether generic or brand-name-is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.’” Id. at 2471 (citing 21 C.F.R. § 314.70(b)(2)(i)). To the extent Plaintiffs are asserting claims of defective design as to amiodarone, those similarly must be dismissed. “[T]here was no action that [Upsher-Smith] could take … to increase the safety of its product without violating the restrictions of the FDCA.” Brinkley v. Pfizer, Inc., 772 F.3d 1133, 1140 (8th Cir. 2014) (holding that Bartlett preempts design-defect claims) (citing Drager v. PLIVA USA, Inc., 741 F.3d 470, 478 (4th Cir. 2014)); see Drager, 741 F.3d at 476 (“[U]nder the FDCA a generic may not unilaterally change its labeling or change its design or formulation, and cannot be required to exit the market or accept state tort liability.”); Strayhorn v. Wyeth Pharms., Inc., 737 F.3d 378, 397 (6th Cir. 2013). VI. Plaintiffs’ Allegations Do Not Satisfy Federal Pleading Requirements Setting aside that Plaintiffs’ claims are preempted, the Amended Complaint fails to satisfy the pleading standards of Rule 8 and Rule 9(b). Plaintiffs improperly lump the defendants together in a series of undifferentiated, conclusory allegations, including alleged fraudulent conduct. See, Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 31 of 34 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 23 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO e.g., Am. Compl. ¶¶ 7(c). Initially, Plaintiffs do not allege which Defendants manufactured the amiodarone consumed by most of the Plaintiffs (or decedents) in the Amended Complaint. Instead, Plaintiffs plead only that these plaintiffs consumed amiodarone “manufactured by one or more of the Generic Defendants.” E.g., id. (emphasis added). This vague manner of pleading does not satisfy Rule 8. As another district court in California held in Adams v. I-Flow Corp., To state a claim against any of the defendants, each plaintiff must allege that each defendant caused his or her alleged injuries. Specifically, in an action such as this, a plaintiff must allege the identity of the particular defendant who manufactured the pain pump and the particular defendant who manufactured the anesthetic that allegedly injured plaintiff. No. CV09-09550, 2010 WL 1339948, at *3 (citing Timmons v. Linvatec Corp., 263 F.R.D. 582, 584- 85 (C.D. Cal. 2010) (“[T]he Complaint does not allege any facts that would permit a reasonable inference of liability against AstraZeneca, because Plaintiffs are merely speculating that AstraZeneca might have made the particular anesthetic Mrs. Timmons received.”)); see In re Sagent Tech., Inc., 278 F. Supp. 2d 1079, 1094 (N.D. Cal. 2003) (“[T]he complaint fails to state a claim because plaintiffs do not indicate which individual defendant or defendants were responsible for which alleged wrongful act.”); In re iPhone Application Litig., No. 11-MD-02250-LHK, 2011 WL 4403963, at *8 (N.D. Cal. Sept. 20, 2011) (dismissing complaint for failure to satisfy Rule 8 because “Plaintiffs’ failure to allege what role each Defendant played in the alleged harm makes it exceedingly difficult, if not impossible, for individual Defendants to respond to Plaintiffs’ allegations”). 14 Plaintiffs’ failure to plead these facts is especially egregious given that they have access to their own pharmacy records, which identify, through National Drug Codes, each amiodarone manufacturer. This same plaintiffs’ counsel has previously identified amiodarone manufacturers by referencing the National Drug Codes, which are publicly available on FDA’s website. See note 3, 14 Should the Court find that any Plaintiffs other than Phyllis Bennett and Robert Smith have sufficiently alleged use of Upsher-Smith’s amiodarone, those Plaintiffs’ claims should likewise be dismissed for the reasons set forth in sections II, III, IV, V, and VI. Specifically, the claims are preempted by PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), and Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001), and fail to plead sufficient facts. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 32 of 34 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 24 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO supra. Reference to these codes is even more important here, where dozens of plaintiffs have sued ten different amiodarone manufacturers. Plaintiffs also do not come close to pleading the factual content necessary to satisfy the particularity requirement of Rule 9(b) with respect to alleged fraudulent conduct. To satisfy Rule 9(b), Plaintiffs must plead the “time, place, and specific content of the false representations as well as the identities of the parties to the misrepresentations.” Swartz v. KPMG LLP, 476 F.3d 756, 764 (9th Cir. 2007). In other words, Plaintiffs must allege the “who, what, when, where, and how of the misconduct charged.” Ebeid ex rel. United States v. Lungwitz, 616 F.3d 993, 998 (9th Cir. 2010) (citation omitted). Further, “Rule 9(b) does not allow a complaint to merely lump multiple defendants together but ‘require[s] plaintiffs to differentiate their allegations when suing more than one defendant … and inform each defendant separately of the allegations surrounding his alleged participation in the fraud.’” King v. Nat’l Gen. Ins. Co., 129 F. Supp. 3d 925, 943 (N.D. Cal. 2015) (citing Swartz, 476 F.3d at 764-65); see Destfino v. Reiswig, 630 F.3d 952, 958 (9th Cir. 2011) (affirming dismissal of fraud claim for failure to “set out which of the defendants made which of the fraudulent statements/conduct” and alleging only “‘everyone did everything’ allegations.”). Plaintiffs have not alleged who from Upsher-Smith made any false statements or representations (or omissions), what their precise content was, when and where they were made, or how Mr. Bennett’s and Mr. Smith’s prescribing physicians were misled by them. Instead, Plaintiffs make only conclusory accusations such as the following: • “Defendants have engaged in a calculated and coordinated campaign of silence despite their knowledge of the growing public acceptance of misinformation and misrepresentations regarding both the safety and efficacy of the use of Cordarone® and the generic versions of Amiodarone ….” Am. Compl. ¶ 52; • “Defendants failed to disclose to the FDA, healthcare professionals, consumers, and Plaintiffs the specific material adverse information they possessed concerning the incidents and actual adverse medical events, injuries, and deaths suffered by Cordarone®/Amiodarone users.” Id. ¶ 116; • “Defendants actively concealed … facts and instead actively promoted, or piggy- backed the promotional efforts of innovator brand drug manufacturer Wyeth, for ‘off-label,’ unapproved uses as described herein through various means, including, but not limited to … Formulation of unlawful conspiracies with certain Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 33 of 34 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 25 DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO medical marketing and medical ‘education’ entities to promote - without appearing to promote - such ‘off-label’ uses.” Id.; id. ¶ 116(c); • “Defendants, jointly and severally, concealed this adverse event information [and] they simultaneously engaged in a massive and illegal marketing and promotional scheme in which they aggressively and illegally promoted Cordarone®/Amiodarone for uses never authorized by the FDA.” Id. ¶ 126; • “Defendants’ affirmative misrepresentations and omissions of material fact either directly or indirectly have so infected the market in the United States that physicians and consumers reasonably relied on Defendants’ statements and omitted material facts, to the detriment of their patients and themselves.” Id. ¶ 127; • “Defendants either directly or indirectly marketed, distributed and/or sold Cordarone®/Amiodarone as having approval, characteristics, uses, and benefits that the drug did not have ….” Id. ¶ 132. Accordingly, the Amended Complaint fails to satisfy federal pleading requirements and should be dismissed for this additional reason. CONCLUSION For all the reasons set forth above, the Court should enter an order dismissing Plaintiffs’ claims against Upsher-Smith. Dated: May 22, 2017 Respectfully submitted, SHOOK, HARDY & BACON L.L.P. By: __/s/ G. Gregg Webb__________ G. Gregg Webb Attorneys for Defendant UPSHER-SMITH LABORATORIES, INC. Case 3:17-cv-02609-WHO Document 46 Filed 05/22/17 Page 34 of 34 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 [PROPOSED] ORDER GRANTING DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO 380563 v1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA EDWIN STREED; MARGARET STREED; SHIRLEY MILLER; PHYLLIS BENNETT, individually and as Executor of the Estate of Harvey Bennett; JEROME COBB, individually and on behalf of his Deceased Mother, Genelle Cobb; SANDRA RHODES; CHARLES RHODES; ERNESTINE SALVO, individually and as Personal Representative of the Estate of Theodore Salvo; EDWARD L. BIVINS; SANDRA BIVINS; ARTHUR OLSTAD; KATHLEEN OLSTAD; SHIRLEY HART; ROBERT PERKINS; LARRY SLUSSER; JANICE SUSAN SLUSSER; ELIZABETH CLARK; JOSEPH HUDOCK; RICHARD REED; VICKI REED; RAY J. HUBLER; MAIRE HUBLER; NOAH MEDFORD; KAREN MEDFORD; WILLIAM MURPHY; BONNIE MURPHY; JAMES CALVIN; HELEN CALVIN; ROBERT SMITH; CATHY SMITH, PATRICIA SOPP, individually and as Administrator of the Estate of Philip C. Sopp; JEROME COBB; JENNITH COONTZ; DONALD COONTZ; RITA M. WEAVER; MARVIN BAUMAN; ROWENA BAUMAN; THOMAS BURNS; SUE BURNS; DORIS BUSSELL; FRANCIS GROMADZKI; LEE ANN GROMADZKI; THOMAS GLEW; MARYANN GLEW; WILLIE AYERS; HENRY ACKERMAN; GENIEVE ACKERMAN; EVANS JENKINS; DONALD HACKERSON; CAROLYN HACKERSON; MICHAEL WENDE; EILEEN POWELL, individually and as Personal Representative of the Estate of Robert Powell; ELMO WAYNE DUNCAN; JAMES CIAVARDINI; JEAN CIAVARDINI; JAMES WALZ; MARY Case No. 3:17-cv-02609-WHO [PROPOSED] ORDER GRANTING DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT Date: July 19, 2017 Time: 2:00 p.m. Courtroom: 2, 17 th Floor Judge: Hon. William H. Orrick Case 3:17-cv-02609-WHO Document 46-1 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 [PROPOSED] ORDER GRANTING DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO 380563 v1 BETH WALZ; EDGAR RAY HERTEL; DONNA HERTEL; TRIO CALDWELL; BEVERLY CALDWELL; JUDITH COTE; Plaintiffs, v. WYETH PHARMACEUTICALS, INC.; SANDOZ INC.; EON LABS, INC.; TEVA PHARMACEUTICALS USA, INC.; PAR PHARMACEUTICAL COMPANIES, INC.; ZYDUS PHARMACEUTICALS USA, INC.; TARO PHARMACEUTICALS USA, INC.; UPSHER-SMITH LABORATORIES, INC.; BARR PHARMACEUTICALS, INC.; MAYNE PHARMA, INC.; MCKESSON CORPORATION; and DOES 1-50, Inclusive, Defendants. Case 3:17-cv-02609-WHO Document 46-1 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 [PROPOSED] ORDER GRANTING DEFENDANT UPSHER-SMITH LABORATORIES, INC.’S MOTION TO DISMISS Case No. 3:17-cv-02609-WHO 380563 v1 AND NOW, on this day, the Court considered Defendant UPSHER-SMITH LABORATORIES, INC.’s Motion to Dismiss Plaintiffs’ First Amended Complaint. After considering the briefing and argument of counsel, if any, the Court finds that the Motion should be GRANTED. DATED: _____________________ ________________________________ Hon. William H. Orrick UNITED STATES DISTRICT JUDGE Case 3:17-cv-02609-WHO Document 46-1 Filed 05/22/17 Page 3 of 3