George Alvarez et al v. Abbvie, Inc. et al

NOTICE OF MOTION AND MOTION to Dismiss Case

C.D. Cal.April 24, 2017

1 DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Carolyn Taylor, Esq. (SBN 159347) CTaylor@mpplaw.com MORRIS POLICH & PURDY LLP 600 West Broadway, Suite 500 San Diego, CA 92101 Telephone: (619) 557-0404 Facsimile: (619) 557-0460 Wendi J. Frisch, Esq. (SBN 211555) WFrisch@mpplaw.com MORRIS POLICH & PURDY LLP 1055 West Seventh Street, 24th Floor Los Angeles, CA 90017 Telephone: (213) 891-9100 Facsimile: (213) 488-1178 Attorneys for Defendant, CITRON PHARMA, LLC UNITED STATES DISTRICT COURT FOR THE CENTRAL DISTRICT OF CALIFORNIA GEORGE ALVAREZ AND MICHELLE ALVAREZ, PARENTS OF CHRISTINA ALVAREZ, DECEASED; and the ESTATE OF CHRISTINA M. ALVAREZ, DECEASED, Plaintiffs, vs. ABBVIE, INC. and ABBOTT LABORATORIES, and CITRON PHARMA, LLC, Defendants. Case No.: 2:16-cv-8055-TJH (JEMx) DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) Date: May 22, 2017 Time: UNDER SUBMISSION Courtroom: 9B Judicial Officer: The Honorable Terry J. Hatter, Jr. [Action Filed: October 28, 2016] Case 2:16-cv-08055-TJH-JEM Document 46 Filed 04/24/17 Page 1 of 3 Page ID #:333 2 DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 TO ALL PARTIES AND TO THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on May 22, 2017, or as soon thereafter as the matter may be heard in Courtroom 9B of the United States District Court for the Central District of California, located at 350 W. 1st Street, Los Angeles, California, 90012, defendant Citron Pharma, LLC (“Citron”) will and hereby does move this Court pursuant to Rules 12(b)(6), 9(b), and 8(a) of the Federal Rules of Civil Procedure for an Order dismissing the Original Complaint of plaintiffs George Alvarez, Michelle Alvarez, and the Estate of Christina M. Alvarez (collectively, “Plaintiffs”), on the grounds that Plaintiffs’ Complaint fails to state any claims upon which relief can be granted. As more fully discussed in the concurrently filed Memorandum of Points and Authorities, Plaintiffs’ causes of action all fail as a matter of law because they conflict with federal regulations for generic pharmaceutical manufacturers, like Citron, since it is impossible for generic drug companies to comply with both federal law and state tort law for claims for failure to warn or design defect. Under the United States Supreme Court decisions in PLIVA, Inc. v. Mensing, 564 U.S. 604, 608, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011) and Mut. Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466, 2470, 186 L. Ed. 2d 607 (2013), federal law preempts all of the causes of action Plaintiffs herein have asserted against Citron. Furthermore, the fourth cause of action for Fraud and Negligent Misrepresentation fails to satisfy the heightened pleading requirements under federal law and is properly dismissed. (Fed. R. Civ. P. 9(b) and 12(b)(6).) Similarly, the claims for disgorgement of profits, restitutionary relief, punitive damages, and attorneys’ fees in the Complaint’s Prayer for Relief fail to satisfy federal pleading and substantive state law requirements and are properly dismissed. (Fed. R. Civ. P. 8(a) and 12(b)(6).) Plaintiffs’ Complaint is thus properly dismissed with prejudice and without leave to amend as to Citron because: (1) all of the claims are preempted; (2) the Case 2:16-cv-08055-TJH-JEM Document 46 Filed 04/24/17 Page 2 of 3 Page ID #:334 3 DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Complaint fails to allege sufficient facts to state a claim upon which relief can be granted; and (3) the Complaint cannot be saved by amendment and granting leave to amend would be futile. This Motion is based upon this Notice, the concurrently filed Memorandum of Points and Authorities and Proposed Order, all matters judicially noticeable by this Court, the pleadings, records and files herein, and such further argument and evidence as may be presented at the time of the hearing on this Motion. This Motion is made following the conferences of counsel pursuant to L.R. 7-3 which took place on December 15, 2016 and April 19, 2017. 1 Dated: April 24, 2017 Respectfully Submitted, MORRIS POLICH & PURDY LLP By: /s/ Wendi J. Frisch Carolyn Taylor Wendi J. Frisch Attorneys for Defendant, CITRON PHARMA, LLC 1 Plaintiffs have filed a Motion for Leave to File First Amended Complaint (Docket No. 35), which Citron has opposed (Docket No. 38). Pursuant to the Court’s Chamber Rules, such Motion was taken under submission as of the hearing date of April 3, 2017. Despite the parties’ prior agreement to seek a further extension on Citron’s responsive pleading deadline if there had not been a ruling by April 10, 2017 on Plaintiffs’ Motion for Leave to File First Amended Complaint (paragraph 8 of Docket No. 40), Plaintiffs have declined to enter into another stipulation to extend Citron’s deadline to file a pleading responsive to the Complaint until a date after the Court rules on Plaintiffs’ Motion for Leave to File a First Amended Complaint, necessitating Citron’s filing of its Motion to Dismiss at this time. Case 2:16-cv-08055-TJH-JEM Document 46 Filed 04/24/17 Page 3 of 3 Page ID #:335 1 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Carolyn Taylor, Esq. (SBN 159347) CTaylor@mpplaw.com MORRIS POLICH & PURDY LLP 600 West Broadway, Suite 500 San Diego, CA 92101 Telephone: (619) 557-0404 Facsimile: (619) 557-0460 Wendi J. Frisch, Esq. (SBN 211555) WFrisch@mpplaw.com MORRIS POLICH & PURDY LLP 1055 West Seventh Street, 24th Floor Los Angeles, CA 90017 Telephone: (213) 891-9100 Facsimile: (213) 488-1178 Attorneys for Defendant, CITRON PHARMA, LLC UNITED STATES DISTRICT COURT FOR THE CENTRAL DISTRICT OF CALIFORNIA GEORGE ALVAREZ AND MICHELLE ALVAREZ, PARENTS OF CHRISTINA ALVAREZ, DECEASED; and the ESTATE OF CHRISTINA M. ALVAREZ, DECEASED, Plaintiffs, vs. ABBVIE, INC. and ABBOTT LABORATORIES, and CITRON PHARMA, LLC, Defendants. Case No.: 2:16-cv-8055-TJH (JEMx) MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) Date: May 22, 2017 Time: UNDER SUBMISSION Courtroom: 9B Judicial Officer: The Honorable Terry J. Hatter, Jr. [Action Filed: October 28, 2016] Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 1 of 28 Page ID #:336 2 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 TABLE OF CONTENTS Page I. INTRODUCTION AND SUMMARY OF ARGUMENT ............................ 7 II. STATEMENT OF FACTS ............................................................................ 9 A. Relevant Statutory and Regulatory Background ................................. 9 B. Allegations of Plaintiffs’ Complaint ................................................. 11 III. ARGUMENT ............................................................................................... 12 A. Legal Standard for Motions to Dismiss ............................................. 12 B. Plaintiff’s Causes of Action Are Preempted Under The Supreme Court’s Mensing and Bartlett Decisions ........................................... 13 1. Plaintiffs’ Cause of Action for Negligence/Gross Negligence is Preempted in the Complaint ............................. 17 2. Plaintiffs’ Cause of Action for Fraud and Negligent Misrepresentation is Preempted in the Complaint .................. 18 3. Plaintiffs’ Cause of Action for Negligence Per Se is Preempted in the Complaint .................................................... 19 4. Plaintiffs’ Causes of Action for Wrongful Death and Survival - Loss of Consortium Are Preempted in the Complaint ................................................................................ 20 C. Plaintiffs’ Fourth Cause of Action for Fraud and Negligent Misrepresentation Fails to Satisfy Heightened Pleading Requirements ..................................................................................... 20 D. Plaintiffs’ Improper Claims in the Prayer for Relief Fail as a Matter of Law and Must Be Dismissed. ............................................ 22 1. Plaintiffs’ Claims for Restitution and Disgorgement of Profits Are Improper and Must Be Dismissed. ....................... 23 2. Plaintiffs’ Demand for Punitive Damages Fail as a Matter of Law and Must Be Dismissed. ............................................. 24 3. Plaintiffs’ Demand for Attorneys’ Fees Fails as a Matter of Law and Must Be Dismissed. ............................................. 26 E. The Court Should Dismiss The Complaint Without Leave to Amend ............................................................................................... 27 IV. CONCLUSION ............................................................................................ 28 Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 2 of 28 Page ID #:337 3 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 TABLE OF AUTHORITIES Page(s) Cases Alan Neuman Prods., Inc. v. Albright, 862 F.2d 1388 (9th Cir. 1988) ............................................................................ 21 Ashcroft v. Iqbal, 556 U.S. 662, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009) ........................... 12, 25 Bank of Cal., N.A. v. Opie, 663 F.2d 977 (9th Cir. 1981) .............................................................................. 22 Bell Atl. Corp. v. Twombly, 550 U.S. 544, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007) ........................... 12, 25 Cahill v. Liberty Mutual Ins. Co., 80 F.3d 336 (9th Cir. 1996) ................................................................................ 27 Carrico v. City & County of San Francisco, 656 F.3d 1002 (9th Cir. 2011) ............................................................................ 17 Chang v. Chen, 80 F.3d 1293 (9th Cir. 1996) .............................................................................. 13 Cruz v. HomeBase, 83 Cal. App. 4th 160, 99 Cal. Rptr. 2d 435 (2000) ............................................ 24 Desaigoudar v. Meyercord, 223 F.3d 1020 (9th Cir. 2000) ............................................................................ 21 Destfino v. Reiswig, 630 F.3d 952 (9th Cir. 2011) .............................................................................. 21 Dilley v. C.R. Bard, Inc., No. 2:14-cv-01795-ODW(ASx), 2014 WL 1338877 (C.D. Cal. April 3, 2014) .............................................................................. 25, 26 Dumas v. Kipp, 90 F.3d 386 (9th Cir. 1996) ................................................................................ 13 Edwards v. Marin Park, Inc., 356 F.3d 1058 (9th Cir. 2004) ............................................................................ 20 FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 120 S. Ct. 1291, 146 L. Ed. 2d 121 (2000) ................................... 9 Gaeta v. Perrigo Pharm. Co., 469 Fed. Appx. 556 (9th Cir. 2012) ................................................................... 15 Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 3 of 28 Page ID #:338 4 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Henderson v. Sec. Nat’l Bank, 72 Cal. App. 3d 764, 140 Cal. Rptr. 388 (1977) .......................................... 24, 25 In re Air Crash Disaster Near Cerritos, Cal., On Aug. 31, 1986, 982 F.2d 1271 (9th Cir. 1992) ............................................................................ 22 In re Sony Grand Wega KDF-E A10/A20 Series Rear Projection HDTV Television Litig., 758 F. Supp. 1077 (S.D. Cal. 2010) ................................................................... 20 Kelley v. Corrections Corp. of America, 750 F. Supp. 2d 1132 (E.D. Cal. 2010) .............................................................. 25 Ko v. Mut. Pharm. Co., No. C-13-00890-RMW, 2013 WL 5692375 (N.D. Cal. Oct. 18, 2013) ................................................................................... 15 Korea Supply Co. v. Lockheed Martin Corp., 29 Cal. 4th 1134, 131 Cal. Rptr. 2d 29 (2003) ................................................... 23 Madrid v. Perot Systems Corp., 130 Cal. App. 4th 440, 30 Cal. Rptr. 3d 210 (2005) .......................................... 23 Mason & Dixon Intermodal, Inc. v. Lapmaster, Int’l LLC, 632 F.3d 1056 (9th Cir. 2011) ............................................................................ 22 Moore v. Kayport Package Exp., Inc., 885 F.2d 531 (9th Cir. 1989) .............................................................................. 21 Moretti v. PLIVA, Inc., 579 Fed. Appx. 563 (9th Cir. 2014) ............................................................. 15, 16 Mut. Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466, 186 L. Ed. 2d 607 (2013) ............................ 8, 10, 13, 14, 15, 28 Neilson v. Union Bank of Cal., N.A., 290 F. Supp. 2d 1101 (C.D. Cal. 2003) .............................................................. 20 Odom v. Microsoft Corp., 486 F.3d 541 (9th Cir. 2007) .............................................................................. 13 Ortega v. Natural Balance, Inc., No. CV 13-05942 ABC (Ex), 2013 WL 6596792 (C.D. Cal. December 16, 2013) .......................................................................... 26 Perez v. Nidek Co., Ltd., 711 F.3d 1109 (9th Cir. 2013) ............................................................................ 12 PLIVA, Inc. v. Mensing, 564 U.S. 604, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011) ..... 8, 10, 13, 14, 15, 28 Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 4 of 28 Page ID #:339 5 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Prudential Home Mortgage Co., Inc. v. Superior Court (Centerbank Mortgage Co.), 66 Cal. App. 4th 1236, 78 Cal. Rptr. 2d 566 (1998) .......................................... 23 Quiroz v. Seventh Ave. Center, (2006) 140 Cal. App. 4th 1256, 45 Cal. Rptr. 3d 222 ........................................ 20 Ramona Manor Convalescent Hosp. v. Care Enterprises, 177 Cal. App. 3d 1120, 225 Cal. Rptr. 120 (1986) ............................................ 23 Reynolds Metal Co. v. Alperson, 25 Cal. 3d 124, 599 P.2d 83, 158 Cal. Rptr 1 (1979) ......................................... 26 Semegen v. Weidner, 780 F.2d 727 (9th Cir. 1985) .............................................................................. 21 Sprewell v. Golden State Warriors, 266 F.3d 979 (9th Cir. 2001) .............................................................................. 12 Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097 (9th Cir. 2003) ............................................................................ 21 Whittlestone Inc., v. Handi-Craft Co., 618 F.3d 970 (9th Cir. 2010) .............................................................................. 22 Wilson v. S. Calif. Edison Co., 234 Cal. App. 4th 123, 184 Cal. Rptr. 3d 26 (2015) .......................................... 24 Statutes 21 U.S.C. § 355(a) .................................................................................................... 9 21 U.S.C. § 355(b)(1)(A) ......................................................................................... 9 21 U.S.C. § 355(b)(1)(F) .......................................................................................... 9 21 U.S.C. § 355(d) ................................................................................................... 9 21 U.S.C. § 355(j)(2)(A) .................................................................................. 10, 11 21 U.S.C. § 355(j)(2)(A)(ii) ................................................................................... 10 21 U.S.C. § 355(j)(2)(A)(iii) .................................................................................. 10 21 U.S.C. § 355(j)(2)(A)(iv) .................................................................................. 10 21 U.S.C. § 355(j)(2)(A)(v) ................................................................................... 10 21 U.S.C. § 355(j)(8)(B) ........................................................................................ 10 21 U.S.C. § 355(j)(2)(A)(ii-iii) ................................................................................ 8 28 U.S.C. § 1332 .................................................................................................... 23 Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 5 of 28 Page ID #:340 6 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Cal. Civ. Code § 3294(a) (West 2017)................................................................... 24 Cal. Civ. Code § 3333 (West 2017) ....................................................................... 20 Cal. Civ. Proc. Code § 377.34 (West 2017) ........................................................... 20 Cal. Civ. Proc. Code § 1021 (West 2017) .............................................................. 26 Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat. 1585, “Hatch-Waxman Act.” ...................................................... 9, 10, 14 Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. ......................................................................................... 9 Rules Fed. R. Civ. P. 8(a) ................................................................................................... 8 Fed. R. Civ. P. 9(b) ...................................................................................... 8, 20, 21 Fed. R. Civ. P. 12(b)(6) ................................................................................ 8, 12, 22 Fed. R. Civ. P. 12(f) ............................................................................................... 22 Regulations 21 C.F.R. ................................................................................................................ 10 21 C.F.R. § 314.150(b)(10) ................................................................................ 9, 11 21 C.F.R. § 314.50(c)(2)(i) .................................................................................... 10 21 C.F.R. § 314.50(c)(2)(ix) .................................................................................. 10 21 C.F.R. § 314.50(d)(2) ........................................................................................ 10 21 C.F.R. § 314.50(d)(5)(iv) .................................................................................. 10 21 C.F.R. § 314.50(d)(5)(viii) ................................................................................ 10 21 C.F.R. § 314.70(b)(2)(i) .................................................................................... 11 21 C.F.R. § 314.94(a)(3) ........................................................................................ 12 21 C.F.R. § 314.94(a)(8)(iii) .................................................................................. 11 Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 6 of 28 Page ID #:341 7 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 MEMORANDUM OF POINTS AND AUTHORITIES Defendant Citron Pharma, LLC (“Citron”) respectfully submits its Memorandum of Points and Authorities in support of its Motion to Dismiss the Original Complaint (“Complaint”) of plaintiffs George Alvarez, Michelle Alvarez and the Estate of Christina M. Alvarez (collectively, “Plaintiffs”) on the grounds that, inter alia, the product liability and related claims are expressly preempted by federal law. I. INTRODUCTION AND SUMMARY OF ARGUMENT In their Complaint, Plaintiffs allege that decedent Christina M. Alvarez suffered a loss of life as an alleged result of a Stevens-Johnson syndrome (“SJS”) and toxic epidermal necrolysis (“TEN”) reaction or complications of treatment allegedly caused by divalproex sodium/valproic acid, a generic version of the brand-name drug Depakote. (Complaint, ¶ 1.) According to Plaintiffs, the divalproex sodium/valproic acid at issue was manufactured and marketed by Citron. (Id.) Plaintiffs allege that at the time of Ms. Alvarez’s death in November of 2014, the brand name manufacturers failed to provide any warnings regarding SJS and TEN, and only listed these terms in the adverse reaction section and in the “effects of valproate on other drugs” section of the professional labeling. (Complaint, ¶¶ 89, 90.) Plaintiffs further allege that defendants “knew or should have known that the package insert, patient leaflet or Medical guide, product websites, and the Physician Desk Reference monograph for Depakote products, and/or Citron’s generic version of the drug, did not adequately inform physicians or patients, about all the risks of severe side effects associated with Depakote products … including those related to SJS and TEN.” (Id. at ¶ 111.) On this basis, Plaintiff filed suit against Citron alleging causes of action for Wrongful Death; Survival - Loss of Consortium; Negligence/Gross Negligence; Fraud and Negligent Misrepresentation; and Negligence Per Se. Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 7 of 28 Page ID #:342 8 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Plaintiffs’ claims, however, fail as a matter of law because they conflict with federal regulations for generic pharmaceutical manufacturers, like Citron. Citron is required by federal law to design and manufacture divalproex sodium/valproic acid so that it is chemically equivalent to the FDA-approved brand name drug Depakote. Its labeling must be “the same” as the branded drug. Therefore, Citron could not change the labeling of its generic drug unilaterally in any way that was inconsistent with the branded labeling. (21 U.S.C. §§ 355(j)(2)(A)(ii-iii), 355(j)(2)(A)(v), 21 C.F.R. § 314.150(b)(10).) For these reasons, the United States Supreme Court has held that it is impossible for generic drug companies to comply with both federal law and state tort law claims for failure to warn or design defect. (See, PLIVA, Inc. v. Mensing, 564 U.S. 604, 608, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011) and Mut. Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466, 2470, 186 L. Ed. 2d 607 (2013).) Thus, federal law preempts all of the causes of action Plaintiffs herein have asserted against Citron. Furthermore, the fourth cause of action for Fraud and Negligent Misrepresentation fails to satisfy the heightened pleading requirements under federal law and is properly dismissed. (Fed. R. Civ. P. 9(b) and 12(b)(6).) Similarly, the claims for disgorgement of profits, restitutionary relief, punitive damages, and attorneys’ fees in the Complaint’s Prayer for Relief fail to satisfy federal pleading and substantive state law requirements and should be dismissed. (Fed. R. Civ. P. 8(a) and 12(b)(6).) For these reasons, as further discussed herein, Citron respectfully requests that the Court grant its Motion and dismiss Plaintiffs’ Complaint and each cause of action therein with prejudice. /// /// /// Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 8 of 28 Page ID #:343 9 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 II. STATEMENT OF FACTS A. Relevant Statutory and Regulatory Background Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., drug manufacturers must gain approval from the FDA before marketing any drug in interstate commerce. (21 U.S.C. § 355(a).) In the case of a new brand-name drug, FDA approval can be secured only by submitting a new- drug application (“NDA”). An NDA is a compilation of materials that must include “full reports of [all clinical] investigations which have been made” (21 U.S.C. § 355(b)(1)(A)), relevant nonclinical studies (21 C.F.R. § 314.50(d)(2)) and “any other data or information relevant to an evaluation of the safety and effectiveness of the drug product obtained or otherwise received by the applicant from any source” (21 C.F.R. and § 314.50(d)(5)(iv)). The NDA must also include “the labeling proposed to be used for such drug,” 21 U.S.C. § 355(b)(1)(F); 21 C.F.R. § 314.50(c)(2)(i), and “a discussion of why the [drug’s] benefits exceed the risks under the conditions stated in the labeling,” 21 C.F.R. § 314.50(d)(5)(viii); § 314.50(c)(2)(ix). The FDA may approve an NDA only if it determines that the drug in question is “safe for use” under “the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.” (21 U.S.C. § 355(d).) In order for the FDA to consider a drug safe, the drug’s “probable therapeutic benefits must outweigh its risk of harm.” (FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 140, 120 S. Ct. 1291, 146 L. Ed. 2d 121 (2000).) In order to provide a swifter route for approval of generic drugs, Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat. 1585, popularly known as the “Hatch-Waxman Act.” Under the Hatch- Waxman Act, a generic drug may be approved without the same level of clinical testing required for approval of a new brand-name drug, provided the generic drug is identical to the already-approved brand-name drug in all key respects. Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 9 of 28 Page ID #:344 10 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 First, the proposed generic drug must be chemically equivalent to the approved brand-name drug: it must have the same “active ingredient” or “active ingredients,” “route of administration,” “dosage form,” and “strength” as its brand-name counterpart. (21 U.S.C. §§ 355(j)(2)(A)(ii) and (iii).) Second, a proposed generic must be “bioequivalent” to an approved brand-name drug. (Id., § 355(j)(2)(A)(iv).) That is, it must have the same “rate and extent of absorption” as the brand-name drug. (Id., § 355(j)(8)(B).) Third, the generic drug manufacturer must show that “the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug.” (Id., § 355(j)(2)(A)(v); Mut. Pharm. Co., Inc. v. Bartlett, supra, 133 S. Ct. 2466, 2471, 186 L. Ed. 2d 607.) Once 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.” (21 C.F.R. § 314.70(b)(2)(i).) Generic manufacturers are also prohibited from making any unilateral changes to a drug’s label. (See, 21 C.F.R. §§ 314.94(a)(8)(iii), 314.150(b)(10) [approval for a generic drug may be withdrawn if the generic drug’s label “is no longer consistent with that for (the brand-name) drug” (emphasis added)]; Mut. Pharm. Co., Inc. v. Bartlett, supra, 133 S. Ct. 2466, 2471, 186 L. Ed. 2d 607.) The hallmark of the Hatch-Waxman Act is sameness. In order to receive and maintain FDA approval, generic drugs must be the same as brand-name drugs in every clinically significant way, including having the same FDA-approved labeling as the brand-name drug. (21 U.S.C. § 355(j)(2)(A).) The requirement of sameness applies as long as a generic drug remains on the market. (PLIVA, Inc. v. Mensing, supra, 564 U.S. 604, 613, 131 S. Ct. 2567, 180 L. Ed. 2d 580 [requiring sameness both pre- and post- marketing approval].) The requirement that a Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 10 of 28 Page ID #:345 11 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 generic drug be the “same as” the reference listed drug (“RLD”) (21 U.S.C. § 355(j)(2)(A); 21 C.F.R. § 314.94(a)(3)) is due to the fact that the generic drug’s approval is based on the safety and efficacy information for the RLD. B. Allegations of Plaintiffs’ Complaint In their Complaint, Plaintiffs acknowledge that they seek redress for the loss of decedent Christina M. Alvarez’s life as an alleged result of an SJS and TEN reaction or complications of treatment allegedly caused by divalproex sodium/valproic acid, a generic version of the brand-name drug Depakote, an anti- epileptic drug. 1 (Complaint, ¶ 1.) Plaintiffs allege that although the decedent was prescribed Abbvie, Inc.’s and Abbott Laboratories’ branded Depakote, the decedent’s pharmacy substituted a generic form of Depakote, divalproex sodium/valproic acid. (Id.) According to Plaintiffs, the generic divalproex sodium/valproic acid at issue was manufactured and marketed by Citron. (Id.) Plaintiffs allege that at the time of Ms. Alvarez’s death in November of 2014, the brand name manufacturers failed to provide any warnings regarding SJS and TEN, and only listed these terms in the adverse reaction section and in the “effects of valproate on other drugs” section of the professional labeling for Depakote. (Complaint, ¶¶ 89, 90.) Plaintiffs further allege that defendants “knew or should have known that the package insert, patient leaflet or Medical guide, product websites, and the Physician Desk Reference monograph for Depakote products, and/or Citron’s generic version of the drug, did not adequately inform physicians or patients, about all the risks of severe side effects associated with Depakote products … including those related to SJS and TEN.” (Id. at ¶ 111.) On this basis, Plaintiff filed suit against Citron alleging causes of action for Wrongful Death; Survival - Loss of Consortium; Negligence/Gross Negligence; 1 By referencing allegations of the Complaint herein, Citron in no way affirms or accepts the veracity of such allegations. Citron specifically reserves all rights to contest the accuracy and relevance of such allegations. Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 11 of 28 Page ID #:346 12 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Fraud and Negligent Misrepresentation; and Negligence Per Se. III. ARGUMENT A. Legal Standard for Motions to Dismiss To survive a motion to dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure, a complaint must contain sufficient factual matter, accepted as true, to “‘state a claim to relief that is plausible on its face.’” (Ashcroft v. Iqbal, 556 U.S. 662, 679, 129 S. Ct. 1937, 1951, 173 L. Ed. 2d 868 (2009) [quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007)]; see also, Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1113 (9th Cir. 2013) [citing Iqbal and finding allegations were insufficient because a “look at those allegations reveals virtually nothing because they are no more than conclusory and bare bones words and phrases without any factual content.”].) “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” (Ashcroft v. Iqbal, supra, 556 U.S. 662, 678, 129 S. Ct. 1937, 173 L. Ed. 2d 868, citing Bell Atl. Corp. v. Twombly, supra, 550 U.S. 544, 127 S. Ct. 1955, 167 L. Ed. 2d 929.) It is “plaintiff’s obligation to provide . . . more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” (Bell Atl. Corp. v. Twombly, supra, 550 U.S. 544, 555, 127 S. Ct. 1955, 167 L. Ed. 2d 929.) “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” (Ashcroft v. Iqbal, supra, 556 U.S. 662, 678, 129 S. Ct. 1937, 173 L. Ed. 2d 868.) Moreover, federal courts are not “required to accept as true allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable inferences.” (Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001).) Instead, a complaint must set forth facts which constitute a “plausible claim for relief.” (Ashcroft v. Iqbal, supra, 556 U.S. 662, 679, 129 S. Ct. 1937, 173 L. Ed. 2d 868.) To determine whether a claim Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 12 of 28 Page ID #:347 13 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 is plausible, a court should “draw on its judicial experience and common sense.” (Id.) Although courts generally apply the policy favoring amendment liberally, a court may deny leave to amend where it is clear that “the complaint could not be saved by any amendment.” (See, Chang v. Chen, 80 F.3d 1293, 1296 (9th Cir. 1996) [affirming dismissal of complaint without leave to amend where complaint failed to state claim as a matter of law]; overruled on other grounds by Odom v. Microsoft Corp., 486 F.3d 541, 550 (9th Cir. 2007).) Therefore, when it would be futile to amend the complaint, dismissal may be ordered with prejudice. (Dumas v. Kipp, 90 F.3d 386, 393 (9th Cir. 1996) [upholding dismissal where further amendment would be futile].) Here, the Court should dismiss Plaintiffs’ Complaint with prejudice and without leave to amend as to Citron because: (1) all of the claims are preempted; (2) the Complaint fails to allege sufficient facts to state a claim upon which relief can be granted; and (3) the Complaint cannot be saved by amendment and granting leave to amend would be futile. B. Plaintiff’s Causes of Action Are Preempted Under The Supreme Court’s Mensing and Bartlett Decisions In Mensing, the United States Supreme Court held that state-law tort claims against generic drug manufacturers are preempted by federal law: “The question presented is whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims. We hold that they do.” (564 U.S. 604, 609, 131 S. Ct. 2567, 180 L. Ed. 2d 580.) Indeed, it is a violation of federal law for a generic drug manufacturer to independently add to or strengthen an FDA-approved package insert. Thus, “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” (Id., 564 U.S. 604, 620, 131 S. Ct. 2567, 180 L. Ed. 2d 580.) Where, as here, the answer is “no,” conflicting Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 13 of 28 Page ID #:348 14 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 state law is preempted. As with Plaintiffs’ claims herein, the basis of the Mensing plaintiffs’ claims was that the generic drug’s labeling, i.e., its package insert, did not adequately warn of the risks purportedly associated with the use of the product. (See, Mensing, supra, 564 U.S. 604, 610, 131 S. Ct. 2567, 180 L. Ed. 2d 580.) The generic drug company defendants argued that the plaintiffs’ state-law tort claims were preempted because, under federal law, generic drug manufacturers are not permitted to add to or strengthen the warnings without prior FDA approval. (Id.) The Court found that if generic drug companies were to change their labeling to satisfy a state-law duty, they would violate federal law. (Id. at 2578. [“If the Manufacturers had independently changed their labels to satisfy their state-law duty to attach a safer label to their generic metoclopramide, they would have violated the federal requirement that generic drug labels be the same as the corresponding brand-name drug labels”].) Therefore, the Supreme Court concluded it “was impossible for them to comply with both state and federal law.” (Id. at 2570.) In 2013, the United States Supreme Court reiterated and reinforced Mensing by also recognizing preemption in Mut. Pharm. Co., Inc. v. Bartlett, supra, 133 S. Ct. 2466, 186 L. Ed. 2d 607. In Bartlett, the Court held that state- law design-defect claims (whether based on failure to warn or otherwise) also are preempted by federal law under Mensing. As the Supreme Court unequivocally determined, it is impossible for generic drug manufacturers to comply with both federal law and state tort law that seeks to impose conflicting duties upon generic drug manufacturers. (Id., 133 S. Ct. 2466, 2476-77, 186 L. Ed. 2d 607.) The Hatch-Waxman Act requires the generic version of a name-brand pharmaceutical to be bioequivalent to the name-brand version and carry the same labeling as the name-brand version. In Bartlett, the Court reasoned that it would be impossible for a generic drug manufacturer to abide by both state law Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 14 of 28 Page ID #:349 15 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 (requiring the defendant to alter the formula or labeling of the product to prevent “unreasonable danger”) and the federal law (forbidding the defendant from altering the formula or the labeling). (Id., 133 S. Ct. 2466, 2476-77, 186 L. Ed. 2d 607.) The Court also rejected the plaintiff’s argument that a generic manufacturer could comply with both state and federal law by simply not selling the product. (Id. at 2477.) The Court reasoned that impossibility preemption would be virtually meaningless if a claim of impossibility could be defeated by “the option of ceasing to act.” (Id.) Since Mensing and Bartlett, the Ninth Circuit Court of Appeals and district courts within this circuit have consistently rejected arguments that any of the Plaintiffs’ causes of action against Citron as a generic drug manufacturer can survive the United States Supreme Court’s dual holdings. These Courts have dismissed numerous purported claims involving generic drugs, including, inter alia, claims for strict liability, negligence, breach of express warranty, and breach of implied warranty. (See e.g., Moretti v. PLIVA, Inc., 579 Fed. Appx. 563 (9th Cir. 2014) [affirming dismissal of complaint against generic manufacturer based on preemption]; Gaeta v. Perrigo Pharm. Co., 469 Fed. Appx. 556 (9th Cir. 2012) [affirming district court’s grant of summary judgment in favor of generic drug manufacturer]; Ko v. Mut. Pharm. Co., No. C-13-00890-RMW, 2013 WL 5692375, at *2 (N.D. Cal. Oct. 18, 2013) [dismissing plaintiff’s state-law products liability claims against generic drug manufacturer].) In sum, Mensing and Bartlett, “make clear that tort claims based on a generic manufacturer’s failure to unilaterally strengthen warning claims are preempted by the federal requirement that generic labels display exactly the same information as the federally approved brand-name label, and that tort claims based on a generic manufacturer’s failure to change the chemical composition of the drug are preempted by the federal duty of sameness.” (Moretti v. PLIVA, Inc., supra, 579 Fed. Appx. at 565.) /// Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 15 of 28 Page ID #:350 16 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Plaintiffs’ claims in this lawsuit arise from the decedent’s prescribed use of a generic drug, divalproex sodium. As did the plaintiffs in Mensing and Bartlett, Plaintiffs are attempting to impose liability under state law based on allegedly inadequate warnings that Citron, the manufacturer of a generic drug, could not independently change. Plaintiffs acknowledge that “[a]t the time of the death of Ms. Christina Alvarez in 11/2014, defendants[’] professional package insert never provided any warnings regarding SJS and TEN, but only listed the terms SJS or TEN in the ADVERSE REACTION section . . .” (Complaint, ¶ 89.) Plaintiffs further acknowledge that the warnings section of the labeling for the brand drug Depakote was only modified in 2015 - after Ms. Alvarez’s death - to include additional warnings pertaining to Drug Reaction with Eosinophilia and Systemic Symptoms (“DRESS”). (Complaint, ¶ 100.) According to Plaintiffs, however, “even this revised warning by defendants in no way provides adequate and applicable risk information regarding SJS and TEN.” (Complaint, ¶ 101.) Moreover, to the extent Plaintiffs claim that Citron allegedly failed to timely update labeling, Plaintiffs fail to identify any specific labeling that Citron allegedly failed to timely update that allegedly had any connection to or effect on the injuries allegedly sustained by the decedent. (See, e.g., Moretti v. PLIVA, Inc., supra, 579 Fed. Appx. at 566 [“Moretti has not proposed any action by which PLIVA could comply with the state-law obligations asserted in the Complaint without violating federal law. Although claims based on PLIVA’s failure to update its label in 2004 to match the newly strengthened brand-name label might meet such a test, Moretti conceded at oral argument that she was no longer taking metoclopramide at the time of the label change. Accordingly, the district court properly dismissed all of Moretti’s claims against PLIVA as preempted by federal law.”].) /// Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 16 of 28 Page ID #:351 17 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Plaintiffs complain about the adequacy of the labeling for the product that was present both before and after Ms. Alvarez’s death, but Citron’s federal mandatory duty of “sameness” renders it impossible for Citron to unilaterally alter the labeling for generic drug divalproex sodium. As a result, any cause of action that Plaintiffs possibly could assert fails as a matter of law because Citron, as a generic drug manufacturer, cannot be compelled by state law to act in a manner (i.e., give different or additional warnings) that federal law expressly prohibits. Accordingly, as described further below, all of Plaintiffs’ causes of action are preempted, and this Court should dismiss the Complaint with prejudice and without leave to amend. (See, Carrico v. City & County of San Francisco, 656 F.3d 1002, 1008 (9th Cir. 2011) [leave to amend properly denied where amendment would be futile].) 1. Plaintiffs’ Cause of Action for Negligence/Gross Negligence is Preempted in the Complaint In Plaintiffs’ third cause of action for Negligence/Gross Negligence, they allege that “Had the physician been provided the new safety information regarding all of the risks of DRESS, SJS and TEN, who prescribed the Depakote (divalproex sodium/valproic acid) drug product to decedent, that prescribing physician would not have done so, if he had had known about the additional safety information regarding the risks of SCAR, including DRESS [Drug Reaction with Eosinophilia and Systemic Symptoms], SJS and TEN that was not disseminated to the prescriber, health care professionals or the patient, but in fact was in part added to the labeling after decedent’s death. Furthermore, had decedent, or her parents been provided adequate safety information and directions for use in the [labeling, or in the] Patient Medication Guide, she would not have taken the drug and suffered her death, and resulting injuries, and losses.” (Complaint, ¶ 138, emphasis in original.) /// Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 17 of 28 Page ID #:352 18 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 This cause of action is clearly preempted since the focus is on allegedly inadequate warnings that Citron, as a generic drug manufacturer, could not have changed. 2. Plaintiffs’ Cause of Action for Fraud and Negligent Misrepresentation is Preempted in the Complaint In Plaintiffs’ fourth cause of action for Fraud and Negligent Misrepresentation, they allege that “DEFENDANTS as a drug manufacturer and/or distributor, knew or ought to have realized that the manufacturers and/or distributors of drug products, have a duty to ensure that the [risk-benefit] information [disseminated or] contained in the package inserts, patient information leaflets, or Medication Guides accompanying [or on] their own [respective websites concerning their respective valproate] prescription drug products was accurate, complete, not misleading or fraudulent, and otherwise adequate, and to monitor medical literature and post marketing adverse events and to report any data affecting the safety of the drug to the appropriate agency and/or alert the medical community, Plaintiff’s physicians, and through them about new safety information that would bear on the safe and effective use of the drug product, and directly to the decedent and her healthcare professionals.” (Complaint, ¶ 146.) Plaintiffs further allege in this cause of action that “[i]f decedent’s physicians had known the actual and true facts about the safety information and risks [prior to October of 2014], then decedent’s physicians and decedent, either would not have been prescribed Depakote (divalproex sodium/valproic acid) and Plaintiff would not have [been prescribed, or otherwise would not have] taken Depakote [and/or generic] (divalproex sodium/valproic acid), and this wrongful death would not have occurred.” (Complaint, ¶ 150.) This cause of action is also preempted because it seeks to change labeling for the drug, which Citron, as a generic drug manufacturer, could not have Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 18 of 28 Page ID #:353 19 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 changed. 3. Plaintiffs’ Cause of Action for Negligence Per Se is Preempted in the Complaint In Plaintiffs’ fifth cause of action for Negligence Per Se, they allege that “Defendants falsely and fraudulently represented to decedent physicians, and through them to Plaintiff and member of the general public, that Depakote (divalproex sodium/valproic acid) was safe and that a severe side effect as described herein, including DRESS, SJS and/or TEN, were either not causal, or comparatively rare, or did not have increased risks of DRESS, SJS and TEN in certain populations. These representations were, in fact, false. The true facts are that Depakote (divalproex sodium/valproic acid) is not safe and is in fact, dangerous to the health and body of decedent, and others similarly situated. . . . Defendants made other representations about the safety and efficacy of Depakote (divalproex sodium/valproic acid), and its minimal side effects all as set forth above and incorporated herein by reference. Depakote (divalproex sodium/valproic acid) causes severe side effects as described herein including DRESS, SJS and/or TEN, and deaths, far more frequently than represented, and Defendants did not disclose or warn physicians about the actual prevalence, degree or risks, i.e. death, or quantification of risks of SCAR events, or even whether subpopulations like decedent were at higher risks of known side effects of Depakote (divalproex sodium/valproic acid).” (Complaint, ¶¶ 154-155.) Once again, these allegations make clear that Plaintiffs are attempting to impose liability under state law based on allegedly inadequate warnings that Citron, the manufacturer of a generic drug, could not independently change. As such, this cause of action is preempted as to Citron. /// /// /// Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 19 of 28 Page ID #:354 20 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 4. Plaintiffs’ Causes of Action for Wrongful Death and Survival - Loss of Consortium Are Preempted in the Complaint Because the first cause of action for Wrongful Death and second cause of action for Survival - Loss of Consortium are derivative of the three tort causes of action, these two causes of action also fail since there is no underlying tort or wrongful act upon which damages may be recovered. (See, Quiroz v. Seventh Ave. Center (2006) 140 Cal. App. 4th 1256, 1263, 45 Cal. Rptr. 3d 222 [elements of cause of action for wrongful death require underlying tort]; Cal. Civ. Proc. Code § 377.34 (West 2017) [the damages recoverable in a survival action are limited to the loss or damage that the decedent sustained or incurred before death]; Cal. Civ. Code, § 3333 (West 2017) [recovery of damages requires “detriment proximately caused” by defendant’s tortious conduct].) Accordingly, these causes of action are also properly dismissed. C. Plaintiffs’ Fourth Cause of Action for Fraud and Negligent Misrepresentation Fails to Satisfy Heightened Pleading Requirements Plaintiffs’ fourth cause of action for Fraud and Negligent Misrepresentation sounds in fraud. To survive a motion to dismiss for failure to state a claim, a complaint alleging fraud must satisfy the heightened pleading standards contained in Rule 9(b) of the Federal Rules of Civil Procedure. (See, Edwards v. Marin Park, Inc., 356 F.3d 1058, 1066 (9th Cir. 2004) [fraud]; Neilson v. Union Bank of Cal., N.A., 290 F. Supp. 2d 1101, 1141 (C.D. Cal. 2003) [negligent misrepresentation]; In re Sony Grand Wega KDF-E A10/A20 Series Rear Projection HDTV Television Litig., 758 F. Supp. 1077, 1088 (S.D. Cal. 2010) [fraudulent concealment and fraudulent misrepresentation].) Rule 9(b) states that “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake. (Fed. R. Civ. P. Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 20 of 28 Page ID #:355 21 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 9(b). See also, Desaigoudar v. Meyercord, 223 F.3d 1020, 1022-23 (9th Cir. 2000) [fraud must be pled with “a high degree of meticulousness.”].) Rule 9(b) serves to deter the filing of complaints “as a pretext for the discovery of unknown wrongs,” to protect professionals from the harm that comes from being subject to fraud charges, and to prohibit plaintiffs from “unilaterally imposing upon the court, the parties and society enormous social and economic costs absent some factual basis.” (Semegen v. Weidner, 780 F.2d 727, 731 (9th Cir. 1985).) The Ninth Circuit has interpreted Rule 9(b) to mean that plaintiffs must state “the time, place, and specific content of the false representations, as well as the identities of the parties to the misrepresentation.” (Alan Neuman Prods., Inc. v. Albright, 862 F.2d 1388, 1392-93 (9th Cir. 1988).) In other words, “[a]verments of fraud must be accompanied by the ‘who, what, when, where, and how’ of the misconduct charged.” (Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1106 (9th Cir. 2003) (citation omitted).) Further, where there are multiple defendants, “Rule 9(b) ‘does not allow a complaint to…lump multiple defendants together but require[s] plaintiffs to differentiate their allegations when suing more than one defendant.” (Destfino v. Reiswig, 630 F.3d 952, 958 (9th Cir. 2011) [affirming dismissal for failure to “set out which of the defendants made which of the fraudulent statements/conduct” and where amended complaint continued to make “‘everyone did everything’ allegations”]; see also, Moore v. Kayport Package Exp., Inc., 885 F.2d 531, 541 (9th Cir. 1989) [allegations of fraud “must identify the time, place, and manner of each fraud plus the role of each defendant in each scheme.”].) Plaintiffs’ Complaint contains only boilerplate, no specific facts that address the “who, what, where, when and how” of the essential elements of their claim sounding in fraud. The fourth cause of action for Fraud and Negligent Misrepresentation is alleged against “All Defendants” and generally alleges that “DEFENDANTS” disseminated inaccurate or misleading information to Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 21 of 28 Page ID #:356 22 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 physicians concerning Depakote or the generic equivalent. (Complaint, ¶ 149.) The Complaint does not identify a specific person or persons at Citron who allegedly made the decision to disseminate allegedly false and misleading information about divalproex sodium/valproic acid. Additionally, the Complaint does not state how or when a specific person or persons at Citron made an alleged decision to so disseminate. In short, none of the “who, what, where, when or how” is provided in regard to the fourth cause of action sounding in fraud. Accordingly, the Complaint’s fourth cause of action for Fraud and Negligent Misrepresentation must be dismissed. D. Plaintiffs’ Improper Claims in the Prayer for Relief Fail as a Matter of Law and Must Be Dismissed. The Federal Rules of Civil Procedure allow the Court to strike from a pleading “an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter.” (Fed. R. Civ. P. 12(f).) While some circuits allow courts to strike damages from a pleading pursuant to Rule 12(f), the Ninth Circuit sees an attempt to “strike” damages as more appropriately decided through a 12(b)(6) motion or motion for summary judgment. (See, Whittlestone Inc., v. Handi-Craft Co., 618 F.3d 970, 973-75 (9th Cir. 2010).) Therefore, the propriety of the claims for relief contained in the Complaint’s Prayer for Relief is to be determined in the same manner as the other matters at issue in this Motion to Dismiss. “When a district court sits in diversity, or hears state law claims based on supplemental jurisdiction, the court applies state substantive law to the state law claims.” (Mason & Dixon Intermodal, Inc. v. Lapmaster, Int’l LLC, 632 F.3d 1056, 1060 (9th Cir. 2011).) State law creates the right to recovery in diversity actions and governs the elements of the causes of action and the measure of the damages. (See, Bank of Cal., N.A. v. Opie, 663 F.2d 977, 980 (9th Cir. 1981); In re Air Crash Disaster Near Cerritos, Cal., On Aug. 31, 1986, 982 F.2d 1271, 1277 (9th Cir. 1992).) Plaintiffs filed their Complaint in this Court based on Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 22 of 28 Page ID #:357 23 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 diversity jurisdiction pursuant to 28 U.S.C. § 1332. (See, Complaint, ¶ 13.) The Complaint contains no federal claims. Thus, California substantive law applies to the claims for relief contained in the Complaint’s Prayer for Relief in this case. As discussed further below, the claims for restitutionary relief, disgorgement of profits, punitive damages, and attorneys’ fees fail as a matter of law and must be dismissed. 1. Plaintiffs’ Claims for Restitution and Disgorgement of Profits Are Improper and Must Be Dismissed. Restitution is a claim for equitable relief, and therefore Plaintiffs must allege facts showing the inadequacy of the available legal remedies. (Ramona Manor Convalescent Hosp. v. Care Enterprises, 177 Cal. App. 3d 1120, 1140, 225 Cal. Rptr. 120 (1986).) A claim for equitable relief, even if brought under a statute authorizing such relief, must allege facts showing the inadequacy of legal remedies. (See Prudential Home Mortgage Co., Inc. v. Superior Court (Centerbank Mortgage Co.), 66 Cal. App. 4th 1236, 1249, 78 Cal. Rptr. 2d 566 (1998).) Further, under California law, a defendant may not be ordered to disgorge profits as “restitution” to a plaintiff where no profits were taken from the plaintiff or if the plaintiff has no ownership interest in those profits. (See, Korea Supply Co. v. Lockheed Martin Corp., 29 Cal. 4th 1134, 1149, 131 Cal. Rptr. 2d 29 (2003); Madrid v. Perot Systems Corp., 130 Cal. App. 4th 440, 455, 30 Cal. Rptr. 3d 210 (2005).) Here, Plaintiffs have included requests for restitutionary relief and disgorgement of profits in the Complaint’s Prayer for Relief. However, Plaintiffs also seek compensatory (monetary) damages. (Complaint, ¶ 1 of Prayer for Relief.) Plaintiffs provide no explanation as to why such legal remedies allegedly would be inadequate so as to necessitate the equitable remedies also sought. Moreover, Plaintiffs do not allege that Citron’s profits were taken from them or Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 23 of 28 Page ID #:358 24 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 their decedent or that they or their decedent have an ownership interest in any of Citron’s profits. Plaintiffs’ requests for restitution and disgorgement of profits therefore clearly exceed the remedies available. Accordingly, the Complaint’s prayer for disgorgement of profits and restitutionary relief (Complaint, ¶¶ 2 and 3 of Prayer for Relief) must be dismissed. 2. Plaintiffs’ Demand for Punitive Damages Fail as a Matter of Law and Must Be Dismissed. Under California law, punitive damages are recoverable only when a plaintiff proves “by clear and convincing evidence that the defendant has been guilty of oppression, fraud, or malice.” (Cal. Civ. Code § 3294(a) (West 2017).) Furthermore, “[c]orporations are legal entities which do not have minds capable of recklessness, wickedness, or intent to injure or deceive. An award of punitive damages against a corporation therefore must rest on the malice of the corporation’s employees.” (Cruz v. HomeBase (2000) 83 Cal. App. 4th 160, 167, 99 Cal. Rptr. 2d 435.) However, “the law does not impute every employee’s malice to the corporation.” (Id.) “Instead, the oppression, fraud, or malice [required by Civil Code section 3294] must be perpetrated, authorized, or knowingly ratified by an officer, director, or managing agent of the corporation.” (Wilson v. S. Calif. Edison Co. (2015) 234 Cal. App. 4th 123, 164, 184 Cal. Rptr. 3d 26.) California courts disfavor punitive damages and will carefully scrutinize any such claim. As the California Court of Appeals reasoned in Henderson v. Sec. Nat’l Bank, 72 Cal. App. 3d 764, 140 Cal. Rptr. 388 (1977): “[S]uch damages are never awarded as a matter of right; they are not favored by the law and they should be granted with the greatest of caution; they will be allowed only in the clearest of cases. To justify their award there must be proof of malice in fact, such malice will not be implied by law; and such malice will never be established by “mere Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 24 of 28 Page ID #:359 25 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 speculation.” (Id., 72 Cal. App. 3d at 771, 140 Cal. Rptr. 388, citations omitted.) Although federal standards govern the pleading requirements applicable to Plaintiffs’ claims for punitive damages in this diversity action, “the application of the pleading standards set forth in Twombly and Iqbal to claims for punitive damages under California law serves the salutary purpose of harmonizing standards applicable to state and federal proceedings while avoiding unnecessary pleading distinctions between consequential and punitive damages claims in diversity proceedings in federal court.” (See, Kelley v. Corrections Corp. of America, 750 F. Supp. 2d 1132, 1147 (E.D. Cal. 2010).) Even supposing a plaintiff may generally aver the elements of “oppression, fraud, or malice” when stating a section 3294 claim under federal law, “Rule 8 does not empower [a plaintiff] to plead the bare elements of his cause of action, affix the label ‘general allegation,’ and expect his complaint to survive a motion to dismiss.” (Dilley v. C.R. Bard, Inc., No. 2:14-cv-01795-ODW(ASx), 2014 WL 1338877, *5 (C.D. Cal. April 3, 2014), quoting Ashcroft v. Iqbal, supra, 556 U.S. at 686-87, 129 S. Ct. 1937, 173 L. Ed. 2d 868.) In this case, Plaintiffs do not allege any necessary supporting facts, which, if proven, would rise to the level of oppression, fraud, or malice, as required to support a claim for punitive damages. Rather, Plaintiffs simply claim entitlement to punitive damages to discourage “DEFENDANTS and others from like conduct.” (See, Complaint, ¶¶ 140, 153, and 163.) Plaintiffs’ conclusory assertions of entitlement to punitive damages based on conduct on the part of “Defendants” with no factual support are insufficient to state a claim for punitive damages against Citron under the pleading standards set forth in Bell Atl. Corp. v. Twombly, supra, 550 U.S. 544, 127 S. Ct. 1955, 167 L. Ed. 2d 929, and Ashcroft v. Iqbal, supra, 556 U.S. 662, 129 S. Ct. 1937, 173 L. Ed. 2d 868. (See, Kelley v. Corrections Corp. of America, supra, 750 F. Supp. 2d Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 25 of 28 Page ID #:360 26 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 1132, 1147-48.) Moreover, Plaintiffs’ “punitive damages” allegations are as to all “Defendants,” and the Complaint does not list a single officer, director or managing agent at Citron who is alleged to have authorized or ratified any specific bad conduct of a specific employee(s), what the specific offending conduct was, and why any alleged authorization or ratification would give rise to a claim for punitive or exemplary damages. (See, Complaint, ¶¶ 140, 153, and 163.) Such failure is fatal to Plaintiffs’ claims for punitive and exemplary damages against this corporate defendant. (See, Dilley v. C.R. Bard, Inc., supra, 2014 WL 1338877, *5. See also, Ortega v. Natural Balance, Inc., No. CV 13-05942 ABC (Ex), 2013 WL 6596792, * 5 (C.D. Cal. December 16, 2013) [“. . . § 3294’s requirement that a corporation may be liable for punitive damages only if the wrongful conduct was committed by an officer, director, or managing agent is a substantive element of the claim, not a procedural requirement like heightened pleading. Because Plaintiffs have failed to plead this substantive element, their punitive damages claim is DISMISSED, but with leave to amend.”].) No conduct justifying the inclusion of a punitive damages claim is properly alleged in the Complaint as to Citron. Absent specific, factual allegations as to Citron, the Complaint’s prayer for punitive damages (Complaint at ¶ 5 of Prayer for Relief) must be dismissed. 3. Plaintiffs’ Demand for Attorneys’ Fees Fails as a Matter of Law and Must Be Dismissed. Under California law, attorneys’ fees are not recoverable unless expressly authorized by statute or by the parties’ contract. (Cal. Civ. Proc. Code § 1021 (West 2017); Reynolds Metal Co. v. Alperson, 25 Cal. 3d 124, 127-28, 599 P.2d 83, 158 Cal. Rptr 1 (1979).) The Complaint does not include a contract between the parties that authorizes attorneys’ fees. Nor do any of the claims asserted in the Complaint entitle Plaintiffs to recover attorneys’ fees. Accordingly, the Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 26 of 28 Page ID #:361 27 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Complaint’s prayer for attorneys’ fees (Complaint, ¶ 6 of Prayer for Relief) must be dismissed. E. The Court Should Dismiss The Complaint Without Leave to Amend Citron’s motion should be granted without leave to amend because any amendment would be futile. (See, Cahill v. Liberty Mutual Ins. Co., 80 F.3d 336, 339 (9th Cir. 1996) [where amendment of litigant’s complaint would be futile, denial of leave to amend is appropriate].) Simply put, federal law preempts Plaintiffs from asserting any state law product liability claims against Citron because Citron’s federal mandatory duty of “sameness” renders it impossible for it to unilaterally alter the labeling of Divalproex Sodium. This is a fundamental failing that cannot be cured by amended pleadings. /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 27 of 28 Page ID #:362 28 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 IV. CONCLUSION In sum, claims brought against generic drug manufacturer defendants, like the claims Plaintiffs have brought against Citron here, do not and cannot survive in light of the United States Supreme Court’s decisions in Mensing and Bartlett, and no amendment can cure this fatal defect. These decisions mandate dismissal of all claims alleged against Citron. Further, the fourth cause of action for Fraud and Negligent Misrepresentation fails to satisfy the heightened pleading requirements under federal law. Similarly, Plaintiff’s improper claims for disgorgement of profits, restitutionary relief, punitive damages, and attorneys’ fees fail as a matter of law and must also be dismissed. Citron respectfully requests that this Court grant its Motion to Dismiss with prejudice and without leave to amend. Dated: April 24, 2017 Respectfully Submitted, MORRIS POLICH & PURDY LLP By: /s/ Wendi J. Frisch Carolyn Taylor Wendi J. Frisch Attorneys for Defendant, CITRON PHARMA, LLC Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 28 of 28 Page ID #:363 1 [PROPOSED] ORDER GRANTING DEFENDANT CITRON PHARMA, LLC’S MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 UNITED STATES DISTRICT COURT FOR THE CENTRAL DISTRICT OF CALIFORNIA GEORGE ALVAREZ AND MICHELLE ALVAREZ, PARENTS OF CHRISTINA ALVAREZ, DECEASED; and the ESTATE OF CHRISTINA M. ALVAREZ, DECEASED, Plaintiffs, vs. ABBVIE, INC. and ABBOTT LABORATORIES, and CITRON PHARMA, LLC, Defendants. Case No.: 2:16-cv-8055-TJH (JEMx) [PROPOSED] ORDER GRANTING DEFENDANT CITRON PHARMA, LLC’S MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) Date: May 22, 2017 Time: UNDER SUBMISSION Courtroom: 9B Judicial Officer: The Honorable Terry J. Hatter, Jr. The Honorable Terry J. Hatter, Jr. [Action Filed: October 28, 2016] Case 2:16-cv-08055-TJH-JEM Document 46-2 Filed 04/24/17 Page 1 of 3 Page ID #:364 2 [PROPOSED] ORDER GRANTING DEFENDANT CITRON PHARMA, LLC’S MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 Defendant Citron Pharma, LLC’s (“Citron”) Motion to Dismiss Plaintiffs’ Original Complaint Pursuant to FRCP Rules 12(b)(6), 9(b), and 8(a) was taken under submission on May 22, 2017. After full consideration of the papers submitted by the parties, the oral argument of counsel, if any, the pleadings on file herein, those facts which are properly judicially noticed by this Court and good cause appearing therefor, the Court hereby ORDERS as follows: Citron’s Motion to Dismiss Plaintiffs’ Original Complaint Pursuant to FRCP Rule 12(b)(6), 9(b), and 8(a) is hereby GRANTED. Each of Plaintiffs’ causes of action fail as a matter of law because they conflict with federal regulations for generic pharmaceutical manufacturers, like Citron, since it is impossible for generic drug companies to comply with both federal law and state tort law claims for failure to warn or design defect. Under the United States Supreme Court decisions in PLIVA, Inc. v. Mensing, 564 U.S. 604, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011) and Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2470, 186 L. Ed. 2d 607 (2013), federal law preempts all of the causes of action Plaintiffs herein have asserted against Citron. Furthermore, the fourth cause of action for Fraud and Negligent Misrepresentation fails to satisfy the heightened pleading requirements under federal law and is properly dismissed. (Fed. R. Civ. P. 9(b) and 12(b)(6).) Similarly, the claims for disgorgement of profits, restitutionary relief, punitive damages, and attorneys’ fees in the Complaint’s Prayer for Relief fail to satisfy federal pleading and substantive state law requirements and are properly dismissed. (Fed. R. Civ. P. 8(a) and 12(b)(6).) Because all of Plaintiffs’ claims are preempted, the Court finds that granting leave to amend would be futile in this case. (Chang v. Chen, 80 F.3d 1293, 1296 (9th Cir. 1996), overruled on other grounds by Odom v. Microsoft Corp., 486 F.3d 541, 550 (9th Cir. 2007); Cahill v. Liberty Mutual Ins. Co., 80 F.3d 336, 339 (9th Cir. 1996).) Accordingly, Plaintiffs’ Complaint is hereby Case 2:16-cv-08055-TJH-JEM Document 46-2 Filed 04/24/17 Page 2 of 3 Page ID #:365 3 [PROPOSED] ORDER GRANTING DEFENDANT CITRON PHARMA, LLC’S MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 dismissed with prejudice. IT IS SO ORDERED. Dated: _______________________ ___________________________________ Honorable Terry J. Hatter, Jr. United States District Judge Case 2:16-cv-08055-TJH-JEM Document 46-2 Filed 04/24/17 Page 3 of 3 Page ID #:366