Stephanie Patton et al v. Forest Laboratories, LLC

NOTICE Of Motion and Motion to Dismiss Complaint

C.D. Cal.September 18, 2017

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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS GREENBERG TRAURIG, LLP Ginger H. Pigott (SBN 162908) R. Scott Mullen (SBN 308827) 1840 Century Park East Suite 1900 Los Angeles, California 90067-2121 Telephone: (310) 586-7700 Facsimile: (310) 586-7800 pigottg@gtlaw.com Attorneys for Defendant TEVA PHARMACEUTICALS USA, INC. UNITED STATES DISTRICT COURT FOR THE CENTRAL DISTRICT OF CALIFORNIA STEPHANIE PATTON and KENDRICK KNIGHTEN, Plaintiffs, v. ALLERGAN, PLC., ALLERGAN INC., FOREST LABORATORIES, INC., ACTAVIS, PLC, LUPIN PHARMACEUTICALS, INC., CIPLA, LTD., CIPLA USA, INC., TEVA PHARMACEUTICALS USA, INC., CVS PHARMACY, INC., TARGET CORPORATION, RIVERSIDE COUNTY REGIONAL MEDICAL CENTER, and DOES 1-20, inclusive, Defendants. CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS COMPLAINT; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF Fed. R. Civ. P. 12(b)(6) Date: October 16, 2017 Time: 10:00 a.m. Courtroom: 5A Judge: Hon. Michael W. Fitzgerald Complaint Filed: April 4, 2017 [Removed from Superior Court of Riverside County, California, Case No. RIC 1705864] Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 1 of 31 Page ID #:442 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS NOTICE OF MOTION AND MOTION TO DISMISS TO THE COURT, ALL PARTIES, AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on October 16, 2017, at 10:00 a.m., or as soon thereafter as the matter may be heard before the Honorable Michael W. Fitzgerald in the United States District Court for the Central District of California, Courtroom 5A, located on the 5th Floor of the United States Courthouse, at 350 West First Street, Los Angeles, California, Defendant Teva Pharmaceuticals USA, Inc. (“Teva”) will and hereby does move the Court to dismiss the action pursuant to Rules 12(b)(6), 8(a), and 9(b) of the Federal Rules of Civil Procedure. This motion is made following the conference of counsel pursuant to L.R. 7-3 which took place in August, 2017, and on September 12, 2017. Teva moves to dismiss the Complaint on the grounds that the claims for relief asserted fail to state any cause of action upon which relief may be granted. Plaintiffs (1) bring claims that are all preempted entirely by federal law; (2) inadequately plead the claims under Federal Rules of Civil Procedure 8(a) and 9(b); and (3) fail to meet the notice requirements for a Consumer Legal Remedies Act Claim. For these reasons, the claims should be dismissed with prejudice. This motion is based on this Notice of Motion and Motion, the accompanying Memorandum of Points and Authorities, the pleadings and papers filed herein, and the argument of counsel at the time of any hearing. DATED: September 18, 2017 Respectfully submitted, GREENBERG TRAURIG, LLP By /s/ Ginger H. Pigott_________________ Ginger H. Pigott R. Scott Mullen Attorneys for Defendant TEVA PHARMACEUTICALS USA, INC. Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 2 of 31 Page ID #:443 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS TABLE OF CONTENTS Page I. INTRODUCTION ...................................................................................................... 1 II. BACKGROUND AND FACTUAL ALLEGATIONS .............................................. 3 A. The Federal Regulatory Framework For Generic Drugs. ................................ 3 B. Regulatory History Of Teva’s Escitalopram. ................................................... 5 C. Plaintiffs’ Claims Against Teva And The Other Defendants. ......................... 6 III. LEGAL ARGUMENT................................................................................................ 8 A. Each Of Plaintiffs’ Causes Of Action Is Preempted By Federal Law. ............ 8 1. Each Cause Of Action Is Premised On Alleged Failure-To- Warn. ...................................................................................................... 9 2. Plaintiffs’ Failure-To-Warn-Based Claims Are Preempted. ............... 11 3. Courts Have Consistently Dismissed These Claims As Preempted. ............................................................................................ 12 4. Plaintiffs’ Vague Design Defect Claims Are Preempted. ................... 13 5. Plaintiffs’ California Statutory Claims Are Preempted. ...................... 15 B. Plaintiffs’ Claims Are Inadequate Under Federal Pleading Standards. ......... 15 1. Plaintiffs Have Not Alleged That K.K. Ingested a Teva Product........ 17 2. Plaintiffs Fail to Make Specific Allegations Against Teva. ................ 17 3. Plaintiffs Do Not Satisfy Rule 9’s Heightened Pleading Standard. .............................................................................................. 19 C. The Court Should Dismiss Or Strike Plaintiffs’ Punitive Damages Claim. ............................................................................................................. 20 D. Failure To Provide Adequate Notice Is Fatal To A CLRA Claim. ................ 21 E. Futility Of Amendment Supports Dismissal With Prejudice. ........................ 22 IV. CONCLUSION ......................................................................................................... 22 Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 3 of 31 Page ID #:444 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS TABLE OF AUTHORITIES Page(s) Federal Cases Ackerman v. Northwestern Mut. Life Ins. Co., 172 F. 3d 467 (7th Cir. 1999) .................................................................................. 16, 19 In re Apple and AT&T iPad Unlimited Data Plan Litig., 802 F. Supp. 2d 1070 (N.D. Cal. 2011) ......................................................................... 22 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ........................................................................................... 16, 18, 20 Atuahene v. City of Hartford, 10 Fed. App’x 33 (2d Cir. 2001) ................................................................................... 17 Balistreri v. Pacifica Police Dep’t, 901 F. 2d 696 (9th Cir. 1990) .......................................................................................... 8 Bell Atl. Corp. v. Twombly, 550 U.S. 544, 127 S. Ct. 1955 (2007)..................................................................... passim Bouncing Angels, Inc. v. Burlington Ins. Co., No EDCV170015JGBSPX, 2017 WL 1294004 (C.D. Cal. Mar. 20, 2017) ................. 21 Bowdrie v. Sun Pharm. Indus. Ltd., 909 F. Supp. 2d 179 (E.D.N.Y. 2012) ........................................................................... 13 Brinkley v. Pfizer, Inc., No. 10-0274-cv-W-SOW, 2012 WL 1564945 (W.D. Mo. Apr. 12, 2012) ................... 11 Bureerong v. Uvawas, 922 F. Supp. 1450 (C.D. Cal. 1996) .............................................................................. 20 Carrico v. City and Cty. of San Francisco, 656 F. 3d 1002 (9th Cir. 2011) ...................................................................................... 22 Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363 (2000) ......................................................................................................... 8 In re Darvocet, Darvon & Propoxyphene Products Liab. Litig., 756 F. 3d 917 (6th Cir. 2014) .......................................................................................... 9 Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 4 of 31 Page ID #:445 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS Desaigoudar v. Meyercord, 223 F. 3d 1020 (9th Cir. 2000) ................................................................................ 16, 19 Drager v. PLIVA USA, Inc., 741 F. 3d 470 (4th Cir. 2014) .................................................................................... 9, 14 Eckhardt v. Qualitest Pharm., Inc., 751 F. 3d 674 (5th Cir. 2014) .......................................................................................... 9 In re Fosamax Products Liab. Litig. (No. II), 751 F. 3d 150 (3d Cir. 2014) ............................................................................... 9, 13, 14 Freedom Transp., Inc. v. Travelers Companies, Inc., No. EDCV16213JGBSPX, 2016 WL 7496731 (C.D. Cal. Mar. 24, 2016) .................. 21 Freightliner Corp. v. Myrick, 514 U.S. 280 (1995) ......................................................................................................... 8 Funke v. Sorin Grp. USA, Inc., 147 F. Supp. 3d 1017 (C.D. Cal. 2015) ........................................................................... 5 Gaeta v. Perrigo Pharm. Co., 469 F. App’x 556 (9th Cir. 2012) .............................................................................. 2, 13 In re GlenFed, Inc. Sec. Litig., 42 F. 3d 1541 (9th Cir. 1994) ........................................................................................ 16 Holmes v. Hospira, Inc., No. EDCV 12-01708, 2013 WL 12132046 (C.D. Cal. Jan. 10, 2013) .................. 2, 9, 13 HSBC Realty Credit Corp. (USA) v. O’Neill, 745 F.3d 564 (5th Cir. 2014) ......................................................................................... 22 Johnson v. Teva Pharm. USA, Inc., 758 F. 3d 605 (5th Cir. 2014) .......................................................................................... 9 Kearns v. Ford Motor Co., 567 F. 3d 1120 (9th Cir. 2009) .......................................................................... 15, 16, 19 Kelley v. Corr. Corp. of Am., 750 F. Supp. 2d 1132 (E.D. Cal. 2010) ......................................................................... 20 Ko v. Mutual Pharm. Co., Inc., No. C13-0890-RMW, 2013 WL 5692375 (N.D. Cal. Oct. 18, 2013) ....................... 2, 13 Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 5 of 31 Page ID #:446 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS Krainski v. Nev. ex rel. Bd. of Regents, 616 F. 3d 963 (9th Cir. 2010) ........................................................................................ 22 Lashley v. Pfizer, Inc., 750 F. 3d 470 (5th Cir. 2014) .......................................................................................... 9 Laster v. T-Mobile USA, Inc., 407 F. Supp. 2d 1181 (S.D. Cal. 2005).......................................................................... 22 Moretti v. Mutual Pharm. Co., 852 F. Supp. 2d 1114 (D. Minn. 2012) .......................................................................... 11 Moretti v. Wyeth, Inc., 579 F. App’x 563 (9th Cir. 2014) .......................................................................... 2, 9, 12 Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) ......................................................................................... 1, 13, 14 Nikolouzakis v. Exinda Corp., No. 11-1261-LPS-MPT, 2012 WL 3239853 (D. Del. Aug. 7, 2012) .............................. 5 Pension Benefit Guar. Corp. v. White Consol. Indus., 998 F. 2d 1192 (3d Cir. 1993) ......................................................................................... 5 Perez v. Nidek Co. Ltd., 657 F. Supp. 2d 1156 (S. D. Cal. 2009)................................................................... 13, 15 In re Plastic Cutlery Antitrust Litig., No. CIV. A. 96-CV-728, 1998 WL 314655 (E.D. Pa. June 15, 1998) ............................ 5 PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) ............................................................................................ passim Redding v. Freeman Products, Inc., No. 94-C-398, 1998 WL 410922 (N.D. Ill. July 10, 1995) ............................................. 5 Sentinel Offender Servs., LLC v. G4S Secure Sols. (USA), Inc., No. SACV 14-298-JLS, 2014 WL 2511303 (C.D. Ca. June 3, 2014) .......................... 21 Starr v. Baca, 652 F. 3d 1202 (9th Cir. 2011) ...................................................................................... 16 Strayhorn v. Wyeth Pharm., Inc., 737 F. 3d 378 (6th Cir. 2013) ........................................................................................ 14 Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 6 of 31 Page ID #:447 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS Summit Tech., Inc. v. High-Line Med. Instruments Co. Inc., 922 F. Supp. 299 (C.D. Cal. 1996) ................................................................................ 13 United States v. Ritchie, 342 F. 3d 903 (9th Cir. 2003) .......................................................................................... 5 Vess v. Ciba-Geigy Corp. USA, 317 F. 3d 1097 (9th Cir. 2003) ...................................................................................... 16 Whittlestone, Inc. v. Handi-Craft Co., 618 F. 3d 970 (9th Cir. 2010) ........................................................................................ 20 State Cases Eckler v. Neutrogena Corp., 238 Cal. App. 4th 433 (2015) ........................................................................................ 15 Sindell v. Abbott Labs., 26 Cal. 3d 588 (1980) .............................................................................................. 18, 19 Federal Statutes 21 U.S.C. § 355(j)(2)(A) ................................................................................................... 4, 5 21 U.S.C. § 355(j)(2)(A)(i) ............................................................................................. 4, 14 21 U.S.C. § 355(j)(2)(A)(ii) ............................................................................................ 4, 14 21 U.S.C. § 355(j)(2)(A)(iii) ........................................................................................... 4, 14 State Statutes California Business & Professions Code § 17200 .......................................................... 7, 19 California Civil Code § 1770 .......................................................................................... 3, 19 California Civil Code § 1782(a) ......................................................................................... 21 California Civil Code § 1782(a)(2) ............................................................................... 21, 22 California Civil Code § 3294(a) ......................................................................................... 20 Rules Federal Rules of Civil Procedure, Rule 8 ......................................................... 16, 17, 18, 19 Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 7 of 31 Page ID #:448 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS Federal Rules of Civil Procedure, Rule 8(a)(2) .................................................................. 15 Federal Rules of Civil Procedure, Rule 9 ........................................................................... 19 Federal Rules of Civil Procedure, Rule 9(b) ................................................................ passim Federal Rules of Civil Procedure, Rule 12(b)(6) ......................................................... passim Federal Rules of Civil Procedure, Rule 12(f) ..................................................................... 20 Federal Rules of Evidence, Rule 201(b)(2) .......................................................................... 5 Regulations 21 C.F.R. § 314.50(c)(2)(i) ............................................................................................... 3, 8 21 C.F.R. § 314.94(a)(8) ................................................................................................... 3, 8 21 C.F.R. § 314.150(b)(10) ................................................................................................... 4 Constitutional Provisions U.S. Constitution, Article VI, cl. 2 ....................................................................................... 8 Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 8 of 31 Page ID #:449 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS MEMORANDUM OF POINTS AND AUTHORITIES I. INTRODUCTION This action was brought after the death of K.K., the minor daughter of Plaintiffs Stephanie Patton and Kendrick Knighten (“Plaintiffs”), and seeks to attribute their loss to a prescription anti-depressant medication and an alleged failure to warn regarding the risk of teenage suicide. The medication is known by the brand-name Lexapro®, which is manufactured and distributed by Defendant Forest Laboratories, LLC (“Forest”), also sued in this action. Teva is one of 15 manufacturers of the generic version of Lexapro®, known as escitalopram, but one of only three such manufacturers named in this case. As outlined in the two other pending motions to dismiss brought by Co-Defendants Cipla, Ltd. and Cipla USA, Inc. (“the Cipla Defendants”) and Lupin Pharmaceuticals, Inc. (“LPI”), who, like Teva, are also manufacturers of the generic drug escitalopram, those companies who make and sell generic pharmaceutical drugs have a statutory duty of “sameness” with respect to their formulation and labeling, meaning they may not deviate in any substantive respect from the branded drug. See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013). The practical impact is that any tort claims seeking to require different warnings or formulation are preempted by federal law. Id. Plaintiffs’ Complaint proposes several causes of action, but each of them are premised on Teva changing its labeling or acting in a way other than as required by federal law. Therefore, preemption applies as a bar to those claims. By way of background, in Mensing, the Supreme Court held that federal law preempts state law tort claims premised on alleged failure to warn of risks of generic drugs because such claims conflict with federal law requiring generic manufacturers to conform their warnings to the equivalent brand-name product. Mensing, 131 S. Ct. at 2577-78. The Supreme Court subsequently reinforced and expanded Mensing’s scope to include design defect claims and claims alleging a duty to withdraw a product from the market. Bartlett, 133 S. Ct. at 2480. The Ninth Circuit and every other Circuit Court of Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 9 of 31 Page ID #:450 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 2 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS Appeal that has analyzed claims like those brought by Plaintiffs has followed suit, affirming dismissals of negligence, failure to warn, design defect, and other such claims as preempted. See, e.g., Moretti v. Wyeth, Inc., 579 F. App’x 563, 565 (9th Cir. 2014) (finding that the district court properly dismissed claims against the generic manufacturer because the claims were preempted by federal law); see also e.g. Gaeta v. Perrigo Pharm. Co., 469 F. App’x 556, 557 (9th Cir. 2012), aff’g 562 F. Supp. 2d 1091 (N.D. Cal. 2008) (preemption barred claims for defective design, marketing defect, breach of express and implied warranty, negligence, gross negligence, and deceit). The same results have been seen in the Central District of California, where this Court found similar claims to be preempted by under Mensing. For example, in Holmes v. Hospira, Inc., No. EDCV 12-01708 VAP (DTBx), 2013 WL 12132046, at *10-12 (C.D. Cal. Jan. 10, 2013), Judge Phillips dismissed a strict products liability claim alleging that a generic medication caused personal injuries, finding that the plaintiff’s claim, based on the manufacturer’s alleged failure to provide additional information beyond the medication’s labeling required by and in compliance with federal law, was preempted. See Holmes, 2013 WL 12132046 at *12. (The motion was denied in part on grounds not applicable here. Id.) Other District Courts in the Ninth Circuit have reached the same conclusion and in fact have dismissed not only expressly named failure-to-warn claims but also tort and statutory claims based thereon. See, e.g., Moretti v. Wyeth, 579 F. App’x at 565 (affirming dismissal of state law claims, holding “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”); Ko v. Mutual Pharm. Co., Inc., No. C13-0890- RMW, 2013 WL 5692375, at *2 (N.D. Cal. Oct. 18, 2013) (holding that plaintiff’s strict liability, negligence, and unfair competition claims were all “based on a failure-to-warn theory and consequently preempted by federal law”). Because Plaintiffs’ claims here are an expressly identified failure-to-warn claim and state statutory and tort claims based on alleged failure-to-warn, this Court should find them preempted and dismiss Plaintiffs’ Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 10 of 31 Page ID #:451 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 3 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS Complaint for failure to state a claim upon which relief may be granted. In addition, Teva’s motion raises various other independent grounds for dismissal of Plaintiff’s Complaint. First, Plaintiffs have not alleged that the decedent K.K. ingested any Teva product. Second, Plaintiffs do not make any individualized allegations against Teva and instead improperly lump all Defendants into a single amorphous group, against which all claims are then asserted. Third, Plaintiffs fail to plead their fraud-based claims with the specificity required by Rule 9(b) and both fraud and the request for punitive damages must be dismissed. Finally, Plaintiffs failed to provide Teva the statutorily- required notice of its California Consumer Legal Remedies Act claim. For this reason, the claim must be dismissed. Amendment is not a potential solution here. Plaintiffs simply will not be able to bring any claims that can survive the dispositive impact of the applicable legal defenses. Futility of pleading supports dismissal with prejudice at this time. In sum, because Plaintiffs’ claims are preempted by federal law, are otherwise inadequately pled under federal pleading standards, and not presented with the proper notice, Teva’s Motion should be granted, with prejudice, and Teva should be dismissed. II. BACKGROUND AND FACTUAL ALLEGATIONS A. The Federal Regulatory Framework For Generic Drugs. Pursuant to the Federal Food, Drug and Cosmetic Act (“FDCA”), the FDA regulates the approval of both brand name and generic drugs. See 21 C.F.R. § 314.50(c)(2)(i) (brand name); 21 C.F.R. § 314.94(a)(8) (generic). A manufacturer seeking FDA approval to market a new drug must first demonstrate it is safe and effective and its proposed labeling is accurate and adequate, through the filing of a New Drug Application (“NDA”). Mensing, 131 S. Ct. at 2574. This approval process for brand name drugs involves costly and lengthy clinical testing. Id. In contrast, generic drugs are “designed to be a copy of a reference listed drug (typically a brand-name drug), and thus identical in active ingredients, safety, and efficacy.” Mensing, 131 S. Ct. at 2574 n.2. Generic drug manufacturers obtain FDA Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 11 of 31 Page ID #:452 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS approval to manufacture and sell generic drug products under the regulatory framework set forth in what are commonly known as the Hatch-Waxman Amendments (“Hatch- Waxman”), 21 U.S.C. § 355(j)(2)(A). Id. at 2574. Hatch-Waxman changed the approval requirements for generic drugs to require only submission of an Abbreviated New Drug Application (“ANDA”) to show a generic drug is identical in all material respects to a previously-approved NDA, i.e., a brand name drug. 21 U.S.C. § 355(j)(2)(A). Hatch- Waxman also requires that the “labeling proposed [for an ANDA] is the same as the labeling approved for the [brand-name drug].” Mensing, 131 S. Ct. at 2574. To receive FDA approval, an ANDA applicant need not demonstrate its warnings are accurate and adequate, but only that its “warning label is the same as the brand name’s.” Id. The only duty incumbent upon a generic manufacturer under federal law is an ongoing duty of “sameness”-to ensure its generic drug’s labeling remains identical to the reference listed drug to which it is required to remain equivalent. Id at 2574-75. Generic manufacturers are prohibited from independently changing their labeling in any respect without prior FDA approval. Id. at 2577; see also 21 C.F.R. § 314.150(b)(10) (authorizing FDA to revoke approval of a generic drug if its labeling “is no longer consistent with that for the [reference] listed drug”). Thus, to independently change its warning labeling, even to strengthen it, would violate federal law. Mensing, 131 S. Ct. at 2575. This duty of sameness also extends to the drug’s design. Generic manufacturers must show their products are bioequivalent to the brand name reference listed drug. See 21 U.S.C. §§ 355(j)(2)(A)(i)-(iii) (manufacturer must demonstrate that a generic drug contains the same active ingredient(s); employs the same route of administration; presents the same dosage form; and exhibits the same strength as its brand name counterpart). Federal law requires a generic drug to be “identical [to its brand equivalent] in active ingredients, safety, and efficacy,” just as each generic drug must “ensur[e] that its warning label is the same as the brand name’s.” Mensing, 131 S. Ct. at 2574 n.2. Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 12 of 31 Page ID #:453 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS B. Regulatory History Of Teva’s Escitalopram. Escitalopram (full name escitalopram oxalate) is a prescription anti-depressant designed for the treatment of major depressive disorder and other anxiety disorders. Escitalopram was first manufactured and sold by a predecessor to Co-Defendant Forest under the brand name “Lexapro®” in 2002. Plaintiffs allege that their daughter was prescribed Lexapro® and escitalopram in March 2016, but offer no specifics as to the prescriptions-there is no attempt to differentiate between the two medications and no specific allegations as to, for example, dosages prescribed. (See, e.g., Comp. ¶ 26.) Teva, through its subsidiary IVAX Pharmaceuticals, Inc., originally obtained ANDA approval to manufacture generic escitalopram tablets on May 22, 2006.1 Teva was required to submit an ANDA (#76765) to the FDA, demonstrating bioequivalence to Lexapro® and proposing labeling materially identical to Lexapro® labeling. See 21 1 Teva provides this information as background only and by way of a request for judicial notice. Specifically, information on ANDA #76765 relating to IVAX’s approval can be found on the FDA website at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&App lNo=076765 (last visited September 18, 2017). The Court may take judicial notice of public records in deciding a motion to dismiss under Rule 12(b)(6). See Fed. R. Evid. 201(b)(2); Nikolouzakis v. Exinda Corp., No. 11-1261-LPS-MPT, 2012 WL 3239853, at *5 (D. Del. Aug. 7, 2012) (taking judicial notice of a “public document certified by Delaware’s Secretary of State”); In re Plastic Cutlery Antitrust Litig., No. CIV. A. 96-CV- 728, 1998 WL 314655, at *3-4 (E.D. Pa. June 15, 1998) (taking judicial notice of documents from Delaware Secretary of State proving that two defendants were separate corporate entities) (citing Redding v. Freeman Products, Inc., No. 94-C-398, 1998 WL 410922, at *2 (N.D. Ill. July 10, 1995)); Pension Benefit Guar. Corp. v. White Consol. Indus., 998 F. 2d 1192, 1197 (3d Cir. 1993) (stating that public records worthy of judicial notice include letter decisions of government agencies) (citing Phillips v. Bureau of Prisons, 591 F. 2d 966, 968 (D.C. Cir. 1970)); Redding, 1995 WL 410922, at *2 (taking judicial notice of certificates of good standing showing defendants were separate corporate entities). Taking judicial notice of such records does not convert a motion to dismiss into a motion for summary judgment. See United States v. Ritchie, 342 F. 3d 903, 907-08 (9th Cir. 2003); Funke v. Sorin Grp. USA, Inc., 147 F. Supp. 3d 1017, 1022 (C.D. Cal. 2015). Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 13 of 31 Page ID #:454 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS U.S.C. § 355(j)(2)(A). The FDA reviewed and approved the proposed labeling, determining it was materially identical to Lexapro®. Federal law requires Teva to keep the labeling and design consistent with the approved labeling and design for Lexapro®. Mensing, 131 S. Ct. at 2575-77. Lexapro® and its generics (and other antidepressants) were subject to years of FDA study regarding the risk of suicidality; per those studies, the warning labels were subject to extensive review, and Lexapro® has had the FDA’s strongest “black box” warning label since 2004 calling attention to the risk of suicide in teens.2 See Mensing, 131 S. Ct. at 2573. Plaintiffs have not alleged, and no facts exist to support a claim, that the label for Teva’s escitalopram did not comply with FDA’s requirement of “sameness” as it necessarily must have been to receive ANDA approval in 2006. Thus, even if Plaintiffs could demonstrate K.K. had been prescribed a Teva medication in 2016, there is no evidence the label on it was anything other than as required by FDA. And, to suggest that Teva and/or the other defendants conspired to hide the risk of suicide, as Plaintiffs allege, is nonsensical in the face of the existence of the “black box” warning label. C. Plaintiffs’ Claims Against Teva And The Other Defendants. On April 4, 2017, Plaintiffs filed the Complaint against several pharmaceutical companies involved in the design, manufacture, and distribution of Lexapro® or its generic version, escitalopram.3 While there are 15 manufacturers of escitalopram in the market, Plaintiffs have named only three as Defendants here.4 Throughout the Complaint, 2 Teva requests the Court take judicial notice of the information on the many rounds of label approval for Lexapro® and the Black Box warning required by FDA which can be found on the FDA website at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&App lNo=021323 (last visited September 18, 2017). See legal authority supporting judicial notice listed in footnote 1. 3 Plaintiffs’ Complaint also names pharmacies who allegedly prescribed the medication(s). 4 Teva requests the Court take judicial notice of the information listing manufacturers of escitalopram that can be found on the FDA website at Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 14 of 31 Page ID #:455 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS Plaintiffs lump all of the companies into a single amorphous group of “Defendants” and do not differentiate between them with respect to the alleged conduct. The case was subsequently removed by Forest on May 11, 2017. Plaintiffs generally allege that the decedent K.K. was prescribed and ingested “Lexapro and/or Escitalopram” but do not specify the exact product ingested. (Compl. ¶ 26.) The allegations do not specify any Teva product and are not directed to Teva. The Complaint alleges, against all Defendants, that they “never fully and/or properly informed doctors, pharmacists or other healthcare providers” of the risks of Lexapro® and escitalopram and misled “both consumers and physicians by failing to include a proper warning(s) on the Lexapro/Escitalopram label and/or inserts or in their other Commercial Efforts” regarding the medications. (Compl. ¶ 21.) The Complaint contains failure-to- warn-based claims, including alleging that “Defendants failed and continue to fail to provide proper warnings, warning labels and other information” and that “Defendants failed and refused to include sufficient instructions in their dissemination of information…to the medical profession and/or the general public.” (Id. ¶¶ 24, 31.) In addition, notwithstanding the black box warning, Plaintiffs claim that Defendants were aware and did not warn that Lexapro was a “harmful and unsafe drug which was likely to cause teenage users to make serious attempts at committing suicide.” (Id. ¶ 14). More specifically, Plaintiffs allege seven causes of action: product liability; fraud and deceit; breach of express warranty; “violation of California CLRA;” violation of Business and Professions Code section 17200; negligence; and wrongful death. While Plaintiffs apply different labels to these claims, the root of each claim is that the Defendants did not provide adequate warning regarding escitalopram’s alleged side effects to the public or the medical community. As outlined below, each fails due to application of preemption and the applicable pleading requirements. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&App lNo=021323 (last visited September 18, 2107). See legal authority supporting judicial notice listed in footnote 1. Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 15 of 31 Page ID #:456 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS III. LEGAL ARGUMENT A Rule 12(b)(6) motion tests the legal sufficiency of the claims asserted in the complaint; a Rule 12(b)(6) dismissal is proper where there is either a “lack of a cognizable legal theory” or “the absence of sufficient facts alleged under a cognizable legal theory.” Balistreri v. Pacifica Police Dep’t, 901 F. 2d 696, 699 (9th Cir. 1990). Because Plaintiffs’ claims are preempted by federal law, are inadequately pled, and were brought without proper notice, the action against Teva should be dismissed. A. Each Of Plaintiffs’ Causes Of Action Is Preempted By Federal Law. As discussed above, the FDCA and Hatch-Waxman Amendments operate to govern the approval of both brand-name and generic drugs. See 21 C.F.R. § 314.50(c)(2)(i) (brand-name); 21 C.F.R. § 314.94(a)(8) (generic). This regulatory scheme preempts all actions rooted in failure-to-warn claims under the Supremacy Clause of the U.S. Constitution. The Supremacy Clause provides that federal law “shall be the supreme Law of the Land…and any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const. art. VI, cl. 2. State law is preempted “to the extent of any conflict with a federal statute,” whether such conflict is express or implied. Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372 (2000). Implied preemption arises when it is “‘impossible for a private party to comply with both state and federal requirements.’” Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995) (citing English v. General Elec. Co., 496 U.S. 72, 79 (1990). The Supreme Court has determined that all state tort claims premised upon a generic drug manufacturer’s failure to warn as to its ANDA-approved product are preempted by federal law. Mensing, 131 S. Ct. at 2572. Mensing involved consolidated lawsuits premised on drug manufacturers’ alleged failure to provide adequate warning labels for the generic drug metoclopramide. Id. The drug manufacturer defendants argued that the state law claims directly conflicted with the federal drug regulations applicable to their products; the Supreme Court unequivocally held that the direct conflict existed and that federal law preempted the state law claims. Id. Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 16 of 31 Page ID #:457 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS An overwhelming majority of courts have recognized that Mensing dictates that state law claims premised on a generic drug manufacturer’s alleged insufficient warning, representation, or other disclosure is preempted by federal law. See, e.g., Johnson v. Teva Pharm. USA, Inc., 758 F. 3d 605, 610-14 (5th Cir. 2014) (affirming grant of judgment on the pleadings as to all claims on preemption grounds); In re Darvocet, Darvon & Propoxyphene Products Liab. Litig., 756 F. 3d 917, 926, 931, 934-36 (6th Cir. 2014) (affirming dismissal of all claims as preempted); Eckhardt v. Qualitest Pharm., Inc., 751 F. 3d 674, 682 (5th Cir. 2014) (same); In re Fosamax Products Liab. Litig. (No. II), 751 F. 3d 150, 165 (3d Cir. 2014) (affirming grant of judgment on the pleadings on preemption grounds); Lashley v. Pfizer, Inc., 750 F. 3d 470, 476 (5th Cir. 2014) (affirming dismissal of all claims as preempted); Drager v. PLIVA USA, Inc., 741 F. 3d 470, 473 (4th Cir. 2014) (affirming grant of judgment on the pleadings on preemption grounds); Moretti, 518 F. App’x at 487-488 (same). This Court has likewise dismissed similar claims involving a failure to warn. See Holmes, 2013 WL 12132046 at *12. The same conclusion is warranted here. All of Plaintiffs’ claims against Teva are rooted in alleged inadequate warnings and instructions as to generic escitalopram. Plaintiffs’ claims necessarily contend that Teva’s labeling should have contained different or additional warnings. Such claims are preempted by federal law. Mensing, 131 S. Ct. 2577-81. Moreover, each of Plaintiffs’ individual claims has been found to be preempted under Mensing, and the same result should be reached with respect to the claims against Teva. 1. Each Cause Of Action Is Premised On Alleged Failure-To-Warn. Plaintiffs’ Complaint expressly alleges that the warning labels on the Defendants’ products, including Teva’s escitalopram, were inadequate. For example, Plaintiffs allege that “Defendants…continued to mislead both consumers and physicians by failing to include a proper warning(s) on the Lexapro/Escitalopram label and/or inserts.” (Compl. ¶ 21.) Plaintiffs’ theories necessarily suggest that Teva should have altered the escitalopram label to provide stronger warnings, so as to satisfy state-law duties. Each of Plaintiffs’ Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 17 of 31 Page ID #:458 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS individual causes of action is premised upon Defendants’ purported inadequate warning or other inadequate dissemination of information to consumers or medical providers. To wit: • Under the products liability cause of action, Plaintiffs allege that “Defendants failed and refused to include adequate, required and/or sufficient warnings…in their dissemination of information…to the medical profession and/or the general public[.]” (Compl. ¶ 31.) • Under the fraud and deceit cause of action, Plaintiffs allege that “Defendants…otherwise misrepresented the safety of Lexapro and Escitalopram by representing that both were safe and effective…and concealed warnings of the known or knowable risks” of taking the drugs. (Compl. ¶ 51.) • Under the breach of warranty cause of action, Plaintiffs allege that “Defendants knew that patients and parents had the right to know about the harmful, known side effects of Lexapro and escitalopram…but concealed and intentionally misrepresented same.” (Compl. ¶ 62.) • Under the CLRA cause of action, Plaintiffs again allege that Defendants knew of the drugs’ harmful side effects “but concealed and intentionally misrepresented same.” (Compl. ¶ 67.) • Under the UCL cause of action, Plaintiffs again allege that Defendants “concealed and intentionally misrepresented” the drugs’ known harmful side effects. (Compl. ¶ 71.) • Under the negligence cause of action, Plaintiffs allege that Defendants breached their duty by “failing to properly label, inform, advise, warn, caution and truthfully notify…about the dangers of Lexapro and Escitalopram[.]” (Compl. ¶ 74.) • Finally, under the wrongful death cause of action, Plaintiffs once again allege that “Defendants knew that patients and parents had the right to know about the harmful, known side effects of Lexapro and escitalopram…but concealed Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 18 of 31 Page ID #:459 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS and intentionally misrepresented same.” (Compl. ¶ 80.) Each of Plaintiffs’ causes of action, then, is premised upon the Defendants having known of alleged risks as to the drugs and failing to inform others as to those risks-that is, each claim is premised upon the Defendants’ failure to warn. Thus, the root of Plaintiffs’ claims is that the Defendants’ labeling on the escitalopram products was inadequate and that the Defendants, including Teva, violated a state law duty to provide accurate warning of the risks of using escitalopram, especially to the extent that Defendants did not provide stronger or additional warnings. As discussed at length herein and as further explained below, failure-to-warn-based claims are preempted by federal law, and Plaintiffs’ claims should be dismissed. 2. Plaintiffs’ Failure-To-Warn-Based Claims Are Preempted. Plaintiffs’ claims are premised on the allegation that “Defendants…continued to mislead both consumers and physicians by failing to include a proper warning(s) on the Lexapro/Escitalopram label and/or inserts.” (Compl. ¶ 21.) The individual causes of action are based on the same alleged inadequate warning. These allegations necessarily contend that the labeling should have contained different or additional warnings- precisely the type of claim preempted by Mensing. 131 S. Ct. at 2577-81.5 5 Moreover, multiple courts have recognized that the theories on which Plaintiffs base their claims are in fact premised on failure-to-warn claims. See, e.g., Brinkley v. Pfizer, Inc., No. 10-0274-cv-W-SOW, 2012 WL 1564945, at *3-6 (W.D. Mo. Apr. 12, 2012) (granting judgment on the pleadings as to plaintiffs’ claims for strict liability design defect, breach of warranty, violation of consumer protection statute, failure to communicate and update warnings, and failure to withdraw product and recognizing “that plaintiff is simply trying to backdoor claims against [the generic manufacturer defendant] that the Supreme Court have found to be preempted”); Moretti v. Mutual Pharm. Co., 852 F. Supp. 2d 1114, 1118 (D. Minn. 2012) (granting judgment on the pleadings on negligence, misrepresentation, constructive fraud, violations of state statutes, negligent infliction of emotional distress, negligent misrepresentation, fraud by concealment, failure-to-communicate, failure-to- conduct-and-report-post-market-safety-surveillance, and failure-to-withdraw claims and recognizing that “[d]espite the different ‘labels’ given these claims, the essence of these claims is that important safety information as to [a generic drug] was not disseminated, or made clear, to the public or to the medical community”). Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 19 of 31 Page ID #:460 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS In 2011, the Supreme Court determined all state law tort claims attacking the sufficiency of warnings provided by generic manufacturers about ANDA-approved drugs are preempted by federal law. The consolidated lawsuits at issue in Mensing “involve[d] state-tort law claims based on certain drug manufacturers’ alleged failure to provide adequate warning labels for generic metoclopramide.” Id. at 2572. Faced with the question “whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state law claims,” the Supreme Court held that they do. Id. The majority opinion recognized the dispositive impact on all product liability suits against generic manufacturers, holding “because pharmacists, acting in full accord with state law, substituted generic metoclopramide [for the branded product]…federal law pre-empts these lawsuits.” Id. at 2581 (emphasis added). The dissenting justices also emphasized the impact on suits against generic manufacturers, stating “[i]f [a consumer] takes a generic drug, as occurs 75 percent of the time, she now has no right to sue.” Id. at 2592 (Sotomayor, J., dissenting) (emphasis added). Plaintiffs’ claims all would necessitate Teva altering the labels of its escitalopram product to provide different, stronger, more informative warnings so as to satisfy a state law duty. Plaintiffs allege that Defendants knew of escitalopram’s harmful side effects but gave inadequate warnings or otherwise concealed information as to those side effects. However, federal drug regulations demand “that generic drug labels be the same at all times as the corresponding brand-name drug labels.” Mensing, 131 S. Ct. at 2578. Thus, if Teva “independently changed [its] labels to satisfy their state-law duty, [it] would have violated federal law.” Id. This resulting ”impossibility” of complying with both federal and state law is the foundation of federal preemption; because it is impossible for Teva to comply with both state and federal law, federal law controls, and the failure-to-warn- based claims are preempted. Id. at 2577-78. 3. Courts Have Consistently Dismissed These Claims As Preempted. The overwhelming majority of state and federal courts, including the Ninth Circuit in Moretti v. Wyeth, 579 F. App’x at 565, have recognized the plain impact of Mensing: Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 20 of 31 Page ID #:461 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS no state law tort claims attacking a generic drug’s warnings, representations, or disclosures can survive federal preemption. The Supreme Court reaffirmed and expanded Mensing in Bartlett, 133 S. Ct. at 2470, recognizing that preemption applies to design defect claims or claims alleging a duty to withdraw a product from the market. Since Mensing and Bartlett, federal and state courts have concluded that virtually all products liability, torts, and state law statutory claims against generic manufacturers are preempted-including claims identical to those asserted by Plaintiffs in this action. See, e.g., In re Fosamax, 751 F. 3d at 154, 165 (product liability claims brought “under theories of design defect, failure-to-warn, negligence, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, and negligent misrepresentation” are preempted); Ko, 2013 WL 5692375 at *2 (dismissing all claims, including warranty and unfair competition, as preempted); Holmes, 2013 WL 12132046 at *10 (dismissing plaintiff’s “product liability claim for failure to warn” against generic drug manufacturer as “foreclosed by Mensing”); Bowdrie v. Sun Pharm. Indus. Ltd., 909 F. Supp. 2d 179, 190 (E.D.N.Y. 2012) (dismissing wrongful death claim because “claims upon which [it] depends are preempted under Mensing”); Gaeta, 469 F. App’x at 557 (affirming grant of summary judgment as to claims for defective design, marketing defect, breach of express and implied warranty, negligence, gross negligence, and deceit); Perez v. Nidek Co. Ltd., 657 F. Supp. 2d 1156, 1164-65 (S. D. Cal. 2009), aff’d, 711 F. 3d 1109 (9th Cir. 2013) (“Plaintiffs’ CLRA and UCL claims are dismissed because they impermissibly seek private enforcement of the FDCA.”); Summit Tech., Inc. v. High-Line Med. Instruments Co. Inc., 922 F. Supp. 299, 316 (C.D. Cal. 1996) (Plaintiff cannot bring a UCL claim that is a disguised attempt to state a claim under the FDCA). Plaintiffs’ claims against Teva (although insufficiently pled, as addressed below) are against a generic drug manufacturer as to its generic drug product. Under any of the theories alleged in the Complaint, Plaintiffs’ claims are preempted by federal law. 4. Plaintiffs’ Vague Design Defect Claims Are Preempted. As stated, all of the causes of action contained in the Complaint have been found Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 21 of 31 Page ID #:462 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS preempted by federal Courts. The Complaint also contains ambiguous allegations of “defects” as to the Defendants’ products and that the Defendants’ escitalopram was “defective and unreasonably dangerous” to the extent that the warnings, instructions and directions failed to warn users of said defects. (See Compl. ¶ 34.) The Complaint contains further allegations that the Defendants knew of the purported defects and yet “continued to design, manufacture, market and sell it without providing accurate, adequate and complete warnings…” (See Compl. ¶ 39.) These allegations are without factual support. But, more importantly for this motion, the requirement of “sameness” is also true of the drug’s ingredients/formulation and thus its “design.” To the extent the claim is that the drug should not be sold, that too is a claim subject to preemption. Moreover, the design defect claims are directly preempted by Bartlett, 133 S. Ct. at 2472-73. In Bartlett, the Supreme Court held that state law design defect claims that turn on the adequacy of a drug’s warnings are preempted by federal law under Mensing. Other courts have reached the same conclusion.6 Bartlett further rejected the First Circuit’s conclusion that the manufacturer could satisfy both state and federal law duties if it simply stopped selling the product, thereby obviating the preemption problem. Id. at 2477-78. Under Bartlett, such “stop-selling” claims are not viable and are preempted. Id. Likewise, the regulatory scheme embodied by the FDCA and Hatch-Waxman preempts any manufacturing defect claims, as it is incumbent upon a generic drug manufacturer to show that its products are bioequivalent to their brand-name counterparts. See 21 U.S.C. §355(j)(2)(A)(i)-(iii). A generic drug must be “identical [to its branded equivalent] in active ingredients, safety, and efficacy,” just as its warning label must be identical as the brand name’s. Mensing, 131 S. Ct. at 2574 n.2. Plaintiffs’ nebulous allegations as to 6 See, e.g., In re Fosamax, 751 F. 3d at 165 (dismissing design defect claims as preempted); Drager, 741 F. 3d at 477-78 (judgment on the pleadings for generic manufacturer, as design defect claims were preempted); Strayhorn v. Wyeth Pharm., Inc., 737 F. 3d 378, 397 (6th Cir. 2013) (dismissal of design defect claims against generic manufacturers as preempted). Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 22 of 31 Page ID #:463 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS design and manufacturing defects accordingly must be disregarded and any claims based thereon must be dismissed. 5. Plaintiffs’ California Statutory Claims Are Preempted. The Complaint similarly contains conclusory and unsupported allegations that Defendants’ conduct violated the UCL and CLRA, including, for example, that Defendants knew about the drugs’ harmful side effects “but concealed and intentionally misrepresented same.” (Compl. ¶¶ 67, 71.) As an initial matter, Plaintiffs’ allegations do not satisfy the heightened pleading requirements of Rule 9(b), which apply to consumer protection statutes including the UCL and CLRA. See Kearns v. Ford Motor Co., 567 F. 3d 1120, 1125 (9th Cir. 2009) (“Rule 9(b)’s heightened pleading standards apply to claims for violations of the CLRA and UCL.”). Moreover, Plaintiffs’ UCL and CLRA claims are based on Defendants’ alleged failure to warn, and, as such, are preempted. See Perez, 657 F. Supp. 2d at 1164, aff’d, 711 F. 3d 1109 (“Plaintiffs’ CLRA and UCL claims are dismissed because they impermissibly seek private enforcement of the FDCA.”). Plaintiffs’ UCL and CLRA claims are otherwise preempted for seeking to impose requirements on Teva on top of those already imposed by the FDCA. See Eckler v. Neutrogena Corp., 238 Cal. App. 4th 433, 455-59 (2015). Each theory of liability asserted in the Complaint is based on an alleged failure to warn of escitalopram’s side effects. Each such claim is preempted by federal law under Mensing and its progeny. For this reason, the Complaint should be dismissed. B. Plaintiffs’ Claims Are Inadequate Under Federal Pleading Standards. Plaintiffs’ claims likewise are subject to dismissal under Rule 12(b)(6) for failure to state a claim. Rule 12(b)(6) is read in tandem with Rule 8(a)(2), which requires that a complaint contain “‘a short and plain statement of the claim showing that the pleader is entitled to relief,’ in order to ‘give the defendant fair notice of what the…claim is and the grounds upon which it rests.’” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S. Ct. 1955 (2007) (citation omitted). A complaint must contain “more than labels and conclusions” or a “formulaic recitation of the elements of a cause of action.” Twombly, Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 23 of 31 Page ID #:464 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS 550 U.S. at 555; see also Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (“Rule 8…does not require ‘detailed factual allegations,’ but it demands more than an unadorned, the- defendant-unlawfully-harmed-me accusation.”). In other words, a plaintiff must articulate “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570. “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.” Iqbal, 556 U.S. at 678. “The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully” or “facts that are ‘merely consistent with’ a defendant’s liability.” Id. “Where a complaint pleads facts that are ‘merely consistent with’ a defendant’s liability, it ‘stops short of the line between possibility and plausibility of entitlement to relief.’” Id. (quoting Twombly, 550 U.S. at 556-57. Allegations must contain facts which, when taken as true, “plausibly suggest an entitlement to relief, such that it is not unfair to require the opposing party to be subjected to the expense of discovery and continued litigation.” Starr v. Baca, 652 F. 3d 1202, 1216 (9th Cir. 2011). Furthermore, Plaintiffs’ fraud-based claims are subject to the heightened pleading standard of Rule 9(b). Vess v. Ciba-Geigy Corp. USA, 317 F. 3d 1097, 1102-03 (9th Cir. 2003). And, claims based on California’s consumer protection statutes are also subject to Rule 9(b). Kearns, 567 F. 3d at 1125. Plaintiffs must allege the fraudulent conduct with particularity, which requires the plaintiff to allege “the who, what, when, where, and how” of the allegedly fraudulent conduct. Ackerman v. Northwestern Mut. Life Ins. Co., 172 F. 3d 467, 469 (7th Cir. 1999). That is, a plaintiff must plead its fraud claim “with a high degree of meticulousness.” Desaigoudar v. Meyercord, 223 F. 3d 1020, 1022 (9th Cir. 2000). The party alleging fraud must also “set forth an explanation as to why [a] statement or omission complained of was false and misleading.” In re GlenFed, Inc. Sec. Litig., 42 F. 3d 1541, 1548 (9th Cir. 1994) (superseded by statute on other grounds). Plaintiffs failed to satisfy these standards. Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 24 of 31 Page ID #:465 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS 1. Plaintiffs Have Not Alleged That K.K. Ingested a Teva Product. Plaintiffs’ Complaint makes no specific allegation that K.K. ingested Teva’s product. The Complaint does nothing more than identify Teva as one of four manufacturers of escitalopram sued herein but does not allege anything as to K.K.’s having taken Teva’s product. Instead, Plaintiffs make general allegations suggesting that K.K. took either or both Lexapro® or escitalopram without differentiating between the two. Plaintiffs’ general allegations fail to specify whether K.K. ever took escitalopram produced by Teva. These allegations are mere “labels and conclusions” that are, at most, “merely consistent with” Teva’s liability. Twombly, 550 U.S. at 555-57. Such allegations fall short of the federal pleading standards, and the Complaint should be dismissed. 2. Plaintiffs Fail to Make Specific Allegations Against Teva. Plaintiffs’ Complaint makes no attempt to differentiate between the Defendants other than to identify each entity sued, and improperly makes all allegations against an amorphous group of “Defendants.” (See, e.g., Compl. ¶¶ 11-26 (allegations against “Defendants” or “Defendants and each of them;” allegations against all Defendants under heading of “Facts Common to All Causes of Action”).) Lumping all Defendants into one group and making all allegations against that group is insufficient under federal pleading standards, which require that a pleading give “fair notice” to the defendant of the claim being asserted and the “grounds upon which it rests.” Twombly, 550 U.S. at 555 (citations omitted). Failure to identify which defendant is alleged to be responsible for which alleged violation is fatal to a complaint. See Atuahene v. City of Hartford, 10 Fed. App’x 33, 34 (2d Cir. 2001) (“By lumping all the defendants together in each claim and providing no factual basis to distinguish their conduct, [plaintiff’s] complaint failed to satisfy [Rule 8’s] minimum standard.”). This deficiency permeates Plaintiffs’ Complaint. As stated, Plaintiffs state allegations against all Defendants under the heading “Facts Common to All Causes of Action” and, within that section, present allegations against “Defendants (each individually and all together),” “Defendants, and each of them,” and “Defendants (and Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 25 of 31 Page ID #:466 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS each of them).” (See Compl. ¶¶ 11-26.) Moreover, the Complaint alleges that all Defendants took all actions, including, for example, that the Defendants knew of the purported risks sought to conceal them. (Id.) Plaintiffs likewise assert each cause of action against all Defendants as a single group. (See, e.g., Compl. ¶¶ 28, 50, 58, 64, 69, 73, 78.) Such generalized allegations against all Defendants are devoid of specific facts and allegations against Teva and in fact lump manufacturers of both brand name and generic drugs into the same group. These allegations fail to satisfy Rule 8’s pleading requirements. See, e.g., Iqbal, 556 U.S. at 678 (“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.”). Moreover, Plaintiffs’ allegations, especially as to the existence of a conspiracy or other concerted effort on the part of the Defendants, are conclusory and unsupported by facts and thus insufficient. A complaint must contain “more than labels and conclusions” or a “formulaic recitation of the elements of a cause of action.” Twombly, 550 U.S. at 555. Plaintiffs offer no facts to support the allegations that Defendants “entered into a partnership, employment relationship imputing vicarious liability, joint venture, and/or principal-agent relationship” or otherwise “conspired, cooperated, entered into agreements with each other and otherwise worked collaboratively.” (See Compl. ¶¶ 7, 16.) The unsupported, conclusory allegations against the Defendants as a group fail to satisfy Rule 8’s pleading requirements. Finally, imposition of liability under California law requires “a showing by the plaintiff that his or her injuries were caused by the act of the defendant or by an instrumentality under the defendant’s control[,]” including in cases of defective products. Sindell v. Abbott Labs., 26 Cal. 3d 588, 597-98 (1980). While exceptions to this rule exist, Plaintiffs have not alleged any. To the extent Plaintiffs suggest the allegations as to Defendants’ purported collective action demonstrate concert of action as an alternative theory of liability, Plaintiffs’ claims are still deficient. Concert of action requires more than a litany of charges against all defendants for failure to warn. Id. at 604-05 (“[T]his Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 26 of 31 Page ID #:467 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS litany of charges is insufficient to allege a cause of action under [concert of action theory].”). Plaintiffs must allege facts showing “a tacit understanding or common plan among defendants” to fail to ensure a product’s safety and/or give inadequate warnings, and facts showing that the defendants aided and encouraged one another to do so. Id. Plaintiffs’ Complaint lacks any such allegations. For all of these reasons, Plaintiffs’ complaint does not satisfy Rule 8’s pleading standards and must be dismissed. 3. Plaintiffs Do Not Satisfy Rule 9’s Heightened Pleading Standard. Plaintiffs’ fraud claim and the statutory claims based on Defendants’ allegedly fraudulent conduct all fail to satisfy the heightened pleading requirements of Rule 9(b). Rule 9(b) requires a party to “state with particularity the circumstances constituting fraud or mistake.” Fed. R. Civ. P. 9(b). A plaintiff must plead its fraud claim “with a high degree of meticulousness.” Desaigoudar, 223 F. 3d at 1022. The complaint must set forth “the who, what, when, where, and how” of the allegedly fraudulent conduct. Ackerman, 172 F. 3d at 469. The UCL and CLRA claims are likewise subject to Rule 9(b). See Kearns, 567 F. 3d at 1125 (“Rule 9(b)’s heightened pleading standards apply to claims for violations of the CLRA and UCL.”). Plaintiffs’ general allegations against all Defendants fall short of Rule 9’s requirements, and Plaintiffs make no specific allegations as to Teva. Plaintiffs assert an individual fraud claim and claims under California’s Unfair Competition Law (“UCL”) (California Business & Professions Code Section 17200) and Consumers Legal Remedies Act (“CLRA”) (California Civil Code § 1770) based on Defendants’ alleged fraudulent conduct. Plaintiffs allege that the Defendants “implemented a false, fraudulent and misleading nationwide marketing campaign” regarding Lexapro® and escitalopram; made misrepresentations as to “the source, sponsorship, approval, or certification of goods or services” in violation of the CLRA; and engaged in “fraudulent activity” in violation of the UCL. (Compl. ¶¶ 46; 64-65; 69.) These general, conclusory allegations fall far short of the “high degree of meticulousness” required under Rule 9. Again, Plaintiffs’ allegations are against all Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 27 of 31 Page ID #:468 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS Defendants-Plaintiffs make no effort to identify specific fraudulent conduct on Teva’s part. Even with respect to the claims against all Defendants, Plaintiffs make no effort to identify what the alleged fraudulent conduct was, who acted fraudulently, when or where the conduct took place, or how the fraudulent conduct was accomplished. These unsupported allegations fail to satisfy Rule 9(b) and must be dismissed. C. The Court Should Dismiss Or Strike Plaintiffs’ Punitive Damages Claim. Plaintiffs’ Complaint is devoid of facts supporting any allegations of intentional or malicious conduct. For this reason, Plaintiffs’ prayer for punitive damages is unfounded and should be dismissed or otherwise stricken from the Complaint. See Whittlestone, Inc. v. Handi-Craft Co., 618 F. 3d 970, 973-74 (9th Cir. 2010) (explaining that Rule 12(b)(6) is the appropriate mechanism for seeking dismissal of an improper prayer for relief); see also Bureerong v. Uvawas, 922 F. Supp. 1450, 1479 n.34 (C.D. Cal. 1996) (“Contrary to Plaintiffs’ assertion, a motion to strike may be used to strike any part of the prayer for relief when the damages sought are not recoverable as a matter of law.”).7 Dismissal of the prayer for punitive damages is required here because Plaintiffs have not set forth facts showing oppressive, fraudulent, or malicious conduct. See Cal. Civ. Code § 3294(a) (Identifying oppressive, fraudulent, or malicious conduct as the basis of any punitive damages claim). Under federal Iqbal and Twombly pleading standards, conclusory allegations of malice, fraud, or oppression are insufficient to state a prayer for punitive damages. See Kelley v. Corr. Corp. of Am., 750 F. Supp. 2d 1132, 1147-48 (E.D. Cal. 2010). The Complaint contains nothing more than conclusory allegations. Plaintiffs’ Complaint adduces no facts that Teva engaged in conduct that is subject to punitive damages. At best, Plaintiffs make generic, boilerplate allegations that defendants “acted in a reckless and capricious manner” and that “[t]he recklessness was despicable and done in conscious disregard of the loss of life[.]” (See Compl. ¶¶ 20, 43, 7 Teva believes that the prayer for punitive damages should be dismissed under Rule 12(b)(6). In the alternative, Teva requests that the prayer be stricken under Rule 12(f). Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 28 of 31 Page ID #:469 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS 62, 67, 71, 76, 80.) Moreover, each such baseless allegation is not made against Teva individually but instead is made against all “Defendants” as an amorphous group. Plaintiffs do not allege that K.K. ingested a Teva product and otherwise fail to present a factual basis to support their contention that “Defendants” engaged in fraudulent or otherwise wrongful conduct. Plaintiffs’ insufficient factual allegations doom their prayer for punitive damages in addition to all causes of action. Plaintiffs have not stated a plausible claim for punitive damages; for this reason, the prayer must be dismissed. See Bouncing Angels, Inc. v. Burlington Ins. Co., No EDCV170015JGBSPX, 2017 WL 1294004, at *4 (C.D. Cal. Mar. 20, 2017) (dismissing punitive damages where no “sufficient facts to support a finding of malice, fraud or oppression”); Freedom Transp., Inc. v. Travelers Companies, Inc., No. EDCV16213JGBSPX, 2016 WL 7496731, at *9 (C.D. Cal. Mar. 24, 2016) (conclusory allegations warranted dismissal where no corresponding factual basis existed); Sentinel Offender Servs., LLC v. G4S Secure Sols. (USA), Inc., No. SACV 14-298-JLS JPRX, 2014 WL 2511303, at *9 (C.D. Ca. June 3, 2014) (dismissing claim for punitive damages where complaint lacked factual support). Plaintiffs’ claim here should be dismissed. D. Failure To Provide Adequate Notice Is Fatal To A CLRA Claim. Finally, Plaintiffs’ CLRA claim must be dismissed for failure to provide Teva pre- filing notice of the Complaint, as required by California Civil Code Section 1782(a). Section 1782(a) requires a plaintiff bringing a claim seeking damages under the CLRA to notify the defendant thirty days or more prior to the commencement of the action of the alleged CLRA violations and demand that the defendant rectify the goods or services alleged to be in violation of the CLRA. The notice has to be in writing and sent by certified or registered mail, return receipt requested. Cal. Civ. Code § 1782(a)(2). Plaintiffs did not provide such notice to Teva or the Co-Defendants prior to the action being filed. Recently, on September 11, 2017 and long after the Complaint had already been filed, Plaintiffs appear to have sent a letter purporting to be a notice under the statute. However, the requirements do not allow for a late cure and the failure is dispositive. Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 29 of 31 Page ID #:470 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS Dismissal with prejudice is appropriate where Plaintiff fails to satisfy all requirements of Section 1782(a)(2). Laster v. T-Mobile USA, Inc., 407 F. Supp. 2d 1181, 1196 (S.D. Cal. 2005) (aff’d, 252 F. App’x 777 (9th Cir. 2007) (“[Section] 1782 scrupulously prohibits any action for damages unless its notice provisions are met. As stated, the Legislative goals would be eviscerated if consumers were allowed to sue for damages without first providing the statutorily mandated period for remediation.”); In re Apple and AT&T iPad Unlimited Data Plan Litig., 802 F. Supp. 2d 1070, 1077 (N.D. Cal. 2011) (failure to give notice barred CLRA claim). Accordingly, dismissal is required. E. Futility Of Amendment Supports Dismissal With Prejudice. Plaintiffs will not be able to amend the Complaint to remedy the fatal flaws discussed at length in this motion. Where amendment would be futile, dismissal with prejudice is appropriate. Carrico v. City and Cty. of San Francisco, 656 F. 3d 1002, 1008 (9th Cir. 2011) (Leave to amend properly denied where amendment would be futile, including where party seeking leave offers no allegations that may remedy the complaint’s deficiencies); Krainski v. Nev. ex rel. Bd. of Regents, 616 F. 3d 963, 972 (9th Cir. 2010) (Not an abuse of discretion to dismiss without leave to amend where no new facts could be added to overcome the complaint’s shortcomings). An amendment is futile if it does not plead enough to make out a plausible claim for relief. See HSBC Realty Credit Corp. (USA) v. O’Neill, 745 F.3d 564, 578 (5th Cir. 2014). There are no facts that Plaintiffs could add to their complaint that would avoid preemption and argument about conspiracy is unsupported by any alleged facts. Any amendment would be futile, and the complaint should be dismissed with prejudice. IV. CONCLUSION Teva respectfully submits that the Court should dismiss this action as to Teva in its entirety. Plaintiffs’ claims are preempted by federal law and are insufficiently pled under federal pleading standards. Plaintiffs’ claims under the CLRA are barred for failure to satisfy state law notice requirements. No further amendment will cure these flaws. Accordingly, Teva respectfully requests that the Court grant its Motion to Dismiss and Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 30 of 31 Page ID #:471 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 CASE NO. 5:17-cv-00922 MWF (DTBx) DEFENDANT TEVA PHARMACEUTICALS USA, INC.’S MOTION TO DISMISS dismiss Plaintiffs’ claims against it, with prejudice, for failure to state a claim upon which relief can be granted pursuant to Fed R. Civ. P. 12(b)(6). DATED: September 18, 2017 Respectfully submitted, GREENBERG TRAURIG, LLP By /s/ Ginger H. Pigott__________________ Ginger H. Pigott R. Scott Mullen Attorneys for Defendant TEVA PHARMACEUTICALS USA, INC. Case 5:17-cv-00922-MWF-DTB Document 60 Filed 09/18/17 Page 31 of 31 Page ID #:472