Stephanie Patton et al v. Forest Laboratories, LLC

OPPOSITION to to Dismiss 60 re: TEVA

C.D. Cal.September 21, 2017

1 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 29 30 31 32 Michael S. Traylor, Esq. (SBN 136814) Traylor Law Office, PC 9018 Balboa Blvd., Suite 352 Northridge, CA. 91325 (310) 401-6610 ph (661) 296-9965 fax TraylorLawOffice@gmail.com Attorney for Plaintiffs THE UNITED STATES DISTRICTY COURT FOR THE CENTRAL DISTRICT OF CALIFORNIA WESTERN DISTRICT STEPHANIE PATTON et al. Plaintiffs vs. FORREST LABORATORIES et al. Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case No. 5:17-CV-00922 MWF (DTB) PLAINTIFFS’ JOINT OPPOSITION TO DEFENDANT TEVA’S MOTION TO DISMISS COMPLAINT PURSUANT TO FRCP 12(B)(6) Date: October 16, 2017 Time: 10:00 a.m. Courtroom: 5A Judge: Hon. Michael W. Fitzgerald ) ) Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 1 of 21 Page ID #:498 i 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 29 30 31 32 TABLE OF CONTENTS PAGE I. INTRODUCTION 2 II. ARGUMENT 2 A. The Difficult Standard for Relief Under Rule 12(b)(6) Dictates That the Motion Be Denied 2 B. The Allegations in the Complaint Are Sufficient To Survive an FRCP 12(b)(60) Attack 4 1. TEVA’s Participation in the Lexapro/Escitalopram Conspiracy Is Sufficient to Hold CIPLA Liable for Each Cause of Action Alleged. 5 2. The Fraud-Based Claims And Rule 9(b) 7 C. Pre-Emption and the ANDA 8 1. The First Cause of Action for Product Liability is Not Pre-Empted. 9 2. The Second Cause of Action for Fraud and Deceit is Not Pre-Empted. 11 Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 2 of 21 Page ID #:499 ii 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 29 30 31 32 3. The Third Cause of Action for Breach of Warranty is Not Pre-Empted. 12 4. The Fourth and Fifth Causes of Action (for Violations of California Consumers Laws) is Not Pre-Empted. 12 5. The Sixth and Seventh Causes of Action for Negligence and Wrongful Death. 12 D. Notice Under California Civil Code Section 1782(a). 13 E. Leave To Amend 13 III. CONCLUSION 14 Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 3 of 21 Page ID #:500 iii 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 29 30 31 32 TABLE OF AUTHORITIES TABLE OF CASES Case Page Federal Ashcroft v. Iqbal , 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) 3, 5 Bell Atl. Corp. v. Twombly , 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) 3, 5 Cisco Sys., Inc. v. Stmicroelectronics, Inc. 77 F. Supp.3d. 887 (N.D. Cal. 2014) 6 Conley v. Gibson , 355 U. S. 41, 47 (1957) 3 English v. General Elec. Co. (2013), 496 U.S. 72, 79, 110 S.Ct. 2270, 110 L.Ed.2d 65 10 Gaeta ex rel. A.G. v. Perrigo Pharms. Co., 469 F. App’x 556 (9th Cir. 2012) 11 In Re Fosamax, 751 F.3d 150, 165 (3d Cir. 2014) 11 Medtronic, Inc. v. Lohr , 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) 9 Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 4 of 21 Page ID #:501 iv 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 29 30 31 32 Neitzke v. Williams , 490 U. S. 319, 327 (1989) 4 Newcal Indus., Inc. v. Ikon Office Solution , 513 F.3d 1038, 1043 (9th Cir.2008) 3 Pliva v. Mensing (2011), 131 S.Ct. 2567 9 Sales Corp. v. Olsen, 80 Cal. App. 3d 645, 649 (1978)] 7 Sanjuan v. American Bd. of Psychiatry and Neurology, Inc ., 40 F. 3d 247, 251 (CA7 1994) 3 Scheuer v. Rhodes , 416 U. S. 232, 236 (1974) 4 Schreiber Distributing v. Serv-Well Furniture, 806 F.2d 1393, 1401 (9th Cir. 1986) 14 Seufert v. Merck Sharp & Dohme Corp., 187 F.Supp.3d 1163, 1168 (S.D. Cal. 2016) 9 Swierkiewicz v. Sorema N. A ., 534 U. S. 506, 508 (2002) 4 Wasco Products, Inc. v. Southwall Tech., Inc., 435 F.3d 989, 992 (9th Cir. 2006) 7 Wyeth v. Levine, 555 U.S. 555, 1196 (U.S. 2009) 9 Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 5 of 21 Page ID #:502 v 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 29 30 31 32 California Applied Equip. Corp. v. Litton Saudi Arabia Ltd., 7 Cal. 4th 503, 510-11 (1994) 6 Morgan v. AT & T Wireless Servs., Inc., 177 Cal. App. 4th 1235, 1261, 99 Cal. Rptr. 3d 768, 789 (2009) 12 TABLE OF STATUTES Page California Codes California Civil Code Section 1782(a) 12 C.F.R. 21 C.F.R. § 314.70(b)(2)(i) 10 21 C.F.R. 314.94(a)(8)(iii) 10 21 C.F.R. 314.150(b)(10) 10 F. R. C. P. FRCP 12(b)(6) 3-5, 10, 12 & 14 FRCP 15(a) 14 FRCP Rule 9(b) 7 U. S. C. 21 U.S.C. § 355(a) 10 Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 6 of 21 Page ID #:503 vi 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 29 30 31 32 TABLE OF TEXTS AND TREATISES Page Wright & A. Miller, Federal Practice and Procedure §1216, pp. 235-236 (3d ed. 2004) 4 Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 7 of 21 Page ID #:504 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 I. INTRODUCTION Plaintiffs bring this action based upon the death of their minor daughter (“KK”) who was prescribed the Selective Serotonin Reuptake Inhibitor (SSRI) commonly known as “Lexapro” (and generically as “Escitalopram”) which are purportedly designed by their various manufacturers to treat depression and generalized anxiety disorder. However, early research conducted by the manufacturers of both drugs revealed that the drugs were likely to cause suicide among teenagers and young adults. Defendants conducted a risk/benefit analysis and determined that it would be more economical to defend lawsuits for the death of these vulnerable patients rather than forego the massive profits associated with the introduction of another SSRI. Defendants and each of them manufactured, tested, obtained approval, marketed, packaged and distributed the drug in a negligent and intentionally deceptive manner. Knowing that the drug caused teenagers to have a substantial likelihood of committing suicide, Defendants proceeded to engage in their conduct placing profits over the lives of our youth. The result was the death of KK at age fifteen (15) only a few weeks after being prescribed Lexapro and Escitalopram. II. ARGUMENT A. Intent to File a First Amended Complaint Plaintiff has made known to all defendants its intent to file a First Amended Complaint and suggested same prior to the filing the within motion. In this regard, the matter was originally filed in State Court and was drafted based upon State Court guidelines and the expectation that the matter would rest in the Superior Court of the State of California, County of Los Angeles. As the matter has now been removed to this Court; Plaintiffs requests leave to amend the entire Complaint by filing a First Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 8 of 21 Page ID #:505 3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 Amended Complaint which complies with the more rigorous federal standards of practice and procedure. Furthermore, while Defendants argue that the Complaint contains a lack of specificity; any such shortcomings can easily be cured by the filing of a First Amended Complaint. Irrespective of the Court’s determination of issues in the motion, Plaintiffs contend that leave to file a First Amended Complaint is warranted. In fact, even if the motion is denied, Plaintiff will seek to file a First Amended Complaint for the foregoing reasons. A. The Difficult Standard for Relief Under Rule 12(b)(6) Dictates That the Motion Should Be Denied. At the cornerstone of any Rule 12(b)(6) motion, is the mandate that the Court review the Complaint accepting as true all facts alleged in the complaint, and drawing all reasonable inferences in favor of the plaintiff. Newcal Indus., Inc. v. Ikon Office Solution , 513 F.3d 1038, 1043 n. 2 (9th Cir.2008). To avoid dismissal under Rule 12(b)(6), a plaintiff must aver in his complaint "sufficient factual matter, accepted as true, to `state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal , 129 S.Ct. 1937, 1949, 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)). In order to survive attack under Rule 12(b)(6), Plaintiff only needs to make "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," Conley v. Gibson , 355 U. S. 41, 47 (1957). A complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, ibid .; Sanjuan v. American Bd. of Psychiatry and Neurology, Inc ., 40 F. 3d 247, 251 (CA7 1994). Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 9 of 21 Page ID #:506 4 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 29 30 31 32 Defendant Teva Pharmaceuticals (“TEVA”), like their co-defendants, ignores numerous allegations in the Complaint in an effort to avoid liability. More specifically, they do not acknowledge that Paragraphs 8(b) and Paragraphs 11-25 and 28-32 describe TEVA’s conduct and participation in conspiring with their co- Defendants as part of a scheme to deceive medical professionals and the general public regarding Lexapro/Escitalopram. It is their active participation in this complex conspiracy which ranges from manufacturing to marketing to distribution among all of the defendants that has led to their liability to Plaintiffs. The Complaint details enough facts to support this conspiracy and TEVA’s participation therein. The factual allegations only need to be sufficient enough to raise a right to relief above the speculative level, see 5 C. Wright & A. Miller, Federal Practice and Procedure §1216, pp. 235-236 (3d ed. 2004). The pleading only needs to arise above a statement of facts that creates a suspicion of a legally cognizable right of action. The motion to dismiss may not be based upon the assumption that all the allegations in the complaint are true (even if doubtful in fact), see, e.g., Swierkiewicz v. Sorema N. A ., 534 U. S. 506, 508, n. 1 (2002); Neitzke v. Williams , 490 U. S. 319, 327 (1989) ("Rule 12(b)(6) does not countenance. . . dismissals based on a judge's disbelief of a complaint's factual allegations"); Scheuer v. Rhodes , 416 U. S. 232, 236 (1974) (a well-pleaded complaint may proceed even if it appears "that a recovery is very remote and unlikely"). TEVA’s attempt to mischaracterize and simplify the Complaint as one which is only about a “duty to warn” (See Moving Papers at page 1, line 22 – page 2, line 4) is revelatory of their failure to overcome the high bar for granting a motion under FRCP 12(b)(6). The Complaint meets this standard and TEVA’s motion should be denied. B. The Allegations of the Complaint are Sufficient to Survive an FRCP 12(b)(6) Attack. Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 10 of 21 Page ID #:507 5 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 29 30 31 32 The allegations contained in the Complaint are more than sufficient to survive the attack and Defendants have not established sufficient basis for the Court to consider a 12(b) dismissal of the action. Again, Defendant TEVA attempts to cherry- pick certain allegations and summarize the Complaint in a manner which suits their purpose. To survive a motion to dismiss, a plaintiff must allege "enough facts to state a claim to relief that is plausible on its face." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007) (“Twombly”); Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (“Iqbal”). "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. 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.'" Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 556). 1. TEVA’s Participation in the Lexapro/Escitalopram Conspiracy Is Sufficient to Hold TEVA Liable for Each Cause of Action Alleged. Defendant TEVA states on several occasions that the allegations are not individually directed toward TEVA. While the filing of a First Amended Complaint can easily clarify their feigned confusion; it is noteworthy that the Complaint contains detailed allegations of a conspiracy among the manufacturers of Lexapro/Escitalopram that would impose liability on nearly every cause of action for each defendant …whether or not their particular version of Lexapro/Escitalopram was ingested by KK and caused her death. The joint conduct of each Defendant in deceiving the FDA, the medical community and individuals regarding the dangers of Lexapro/Escitalopram is sufficient to hold each Defendant liable irrespective of Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 11 of 21 Page ID #:508 6 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 29 30 31 32 which manufacturer actually created the deadly pills that ended up in KK’s young body. TEVA cannot exclude liability for their participation in the alleged civil conspiracy by simply asserting that identical claims are made against their co- defendants. TEVA’s participation in a civil conspiracy is detailed throughout the Complaint. They and their co-conspirators jointly engaged in a common plan and unity of interest among the Defendants to earn billions of dollars from a dangerous drug that had unacceptable risk which they jointly concealed and proactively marketed in a fraudulent manner. Conspiracy is not a cause of action, but a legal doctrine that imposes liability on persons and entities (included TEVA) who although not actually committing a tort themselves, share with the immediate tortfeasors a common plan or design in its perpetration. Cisco Sys., Inc. v. Stmicroelectronics, Inc. 77 F. Supp.3d. 887 (N.D. Cal. 2014) citing Applied Equip. Corp. v. Litton Saudi Arabia Ltd., 7 Cal. 4th 503, 510-11 (1994). The conspiracy allegations run throughout the Complaint and each cause of action, in great detail. TEVA can adequately conduct discovery and defend its participation in this conspiracy. The elements of an action for civil conspiracy are (1) the formation and operation of the conspiracy and (2) damage resulting to plaintiff from (3) an act or acts done in furtherance of the common design. Applied Equip. Corp. v. Litton Saudi Arabia Ltd., supra, 7 Cal. 4th 503, 511 (1994). The Complaint sets forth the conspiracy as follows: (a) Generally and, by reference, throughout each Cause of Action in Paragraphs 7 and 10; (b) Specifically and, by reference, throughout each Cause of Action in Paragraphs 11-21, 23 and 25; (c) In connection with the First Cause of Action in Paragraphs 27-31, 36, 38-39 and 43; Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 12 of 21 Page ID #:509 7 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 29 30 31 32 (d) In connection with the Second Cause of Action in Paragraphs 44-52 and 56; (e) In connection with the Third Cause of Action in Paragraphs 57-59 and 62; (f) In connection with the Fourth Cause of Action in Paragraphs 63-64 and 67; (g) In connection with the Fifth Cause of Action in Paragraphs 68-69 and 71; (h) In connection with the Sixth Cause of Action in Paragraphs 72, 74 and 76; and (i) In connection with the Seventh Cause of Action in Paragraphs 77 and 80. The foregoing allegations in the Complaint are sufficient to hold TEVA accountable for every cause of action as a co-conspirator. To allege the formation and operation of the conspiracy, plaintiff must only allege an agreement to commit the wrongful acts. Wasco Products, Inc. v. Southwall Tech., Inc., 435 F.3d 989, 992 (9th Cir. 2006). The conspiracy "may be inferred from the nature of the acts done, the relations of the parties, the interests of the alleged conspirators, and other circumstances." [See, e.g., Sales Corp. v. Olsen, 80 Cal. App. 3d 645, 649 (1978)]. 2. The Fraud-Based Claims and Rule 9(b) Defendants summarily conclude that the fraud-based claims (CLRA, UCL and Fraud) are insufficiently pled. As stated hereinabove, Plaintiff has stated with sufficient detail the elements of the conspiring conduct of the Defendants and their collusion to benefit from the mass production and distribution of both Lexapro and Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 13 of 21 Page ID #:510 8 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 29 30 31 32 Escitalopram. Here, TEVA does not attack the sufficiency of the allegations of fraud (i.e., the who, what, where, when, etc.); but rely on their “lumping” argument. As stated above, TEVA conspired with their co-Defendants in every component of conspiracy and fraudulent conduct. Plaintiff can certainly separate TEVA and the other Defendants and list them individually in an amended complaint should the Court be concerned that the “lumping” violates FRCP Rule 9(b). In this regard, leave to amend is appropriate. C. Pre-Emption and the ANDA Defendant TEVA’s contention of pre-emption is wholly based on their intentionally, narrow reading and misinterpretation of the scope of the allegations against them. They attempt to limit the case to a simple, improper labeling claim. Clearly this is not the case. While the First Amended Complaint, if permitted, will allege that all Defendants also violated the FDA labeling requirements; the focal point of the existing Complaint is the intentional, fraudulent conduct of the parties in risking the lives of teenagers and young adults with Lexapro/Escitalopram. A decision to simply ignore the great majority of the allegations in the Complaint should not be rewarded with a dismissal of proper claims. Likewise, hiding behind the notion of pre-emption should not be rewarded either. As stated in Seufert v. Merck Sharp & Dohme Corp., 187 F.Supp.3d 1163, 1168 (S.D. Cal. 2016), a preemption analysis begins with two governing principles. First, congressional intent is the "ultimate touchstone." Wyeth v. Levine (2009), 555 U.S. 555, 565, 129 S.Ct. 1187 (“Wyeth”). Second, in a field the States have traditionally occupied, there is a presumption against preemption based on the notion that "Congress does not cavalierly pre-empt state-law causes of action." Medtronic, Inc. v. Lohr , 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). These Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 14 of 21 Page ID #:511 9 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 29 30 31 32 principles strongly disfavor Defendant TEVA’s argument that the FDA’s role regarding “labeling” pre-empts seven (7) different areas of State law regarding the safety of products and the making of false representations and intentional distortions of safety information. In a similar fashion, Defendant TEVA ignores the fact that in 2007, Congress amended the FDCA. 121 Stat. 823 and granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug's initial approval. Wyeth v. Levine, 555 U.S. 555, 1196 (U.S. 2009). In fact, the Supreme Court in Wyeth went on to state: Wyeth's cramped reading of the CBE regulation and its broad reading of the FDCA's misbranding and unauthorized distribution provisions are premised on a more fundamental misunderstanding. Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market. See, e.g ., 21 CFR § 201.80(e) (requiring a manufacturer to revise its label “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug”); § 314.80(b) (placing responsibility for postmarketing surveillance on the manufacturer); 73 Fed.Reg. 49605 (“Manufacturers continue to have a responsibility under Federal law ... to maintain their labeling and update the labeling with new safety information”). (emphasis added). Wyeth v. Levine, 555 U.S. 555, 570-71 (U.S. 2009). 1. The First Cause of Action for Product Liability is Not Pre-Empted. Defendant solely relies on the inapplicable ruling in Pliva v. Mensing (2011), 131 S.Ct. 2567 where “[t]he question presented is whether federal drug regulations Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 15 of 21 Page ID #:512 10 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 29 30 31 32 applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims.” Again, this is not the basis of the First Cause of Action. The Federal Food, Drug, and Cosmetic Act (FDCA) requires manufacturers to gain Food and Drug Administration (FDA) approval before marketing any brand- name or generic drug in interstate commerce. 21 U.S.C. § 355(a). Once a drug is approved, a 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 §§ 314.94(a)(8)(iii), 314.150(b)(10). Only a claim that a generic manufacturer made such a unilateral change in violation of State law would be preempted in this regard. Knowingly distributing, marketing, promoting and conspiring to bring an unsafe drug to market is far beyond the scope of the labeling provisions of the FDCA. Defendant TEVA cannot point to any express federal preemption of the claims in the First Cause of Action (and/or any other cause of action in the Complaint). A state law may only be impliedly pre-empted where it is “impossible for a private party to comply with both state and federal requirements.” English v. General Elec. Co. (2013), 496 U.S. 72, 79, 110 S.Ct. 2270, 110 L.Ed.2d 65. It clearly is not impossible to do both under the circumstances alleged in the Complaint. Nothing in the California state laws about manufacturing and distributing dangerous products and concealing those dangerous properties and electing to assume the risk of teenage suicides runs afoul of the Federal requirement that a generic manufacture utilize the same label as the original manufacturer. The claims in the Complaint go far beyond the notion of FDA labeling. Finally, Defendant TEVA’s argument is premature for a FRCP 12(b)(6) motion. Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 16 of 21 Page ID #:513 11 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 29 30 31 32 2. The Second Cause of Action for Fraud and Deceit is Not Pre-Empted. For similar reasons as stated above; the Second Cause of Action is not pre- empted. Like the prior claims, this claim is based on the distribution of fraudulent and deceitful information which was not part of the labeling on Lexapro/Escitalopram. An entire marketing, promotion and advertising campaign (defined as the “Campaign”) in the Complaint have nothing to do with the label on the drugs. As Defendants have taken their efforts well beyond the simple label which is required by the FDA; so goes their risk of liability. TEVA’s reliance on Gaeta ex rel. A.G. v. Perrigo Pharms. Co., 469 F. App’x 556 (9th Cir. 2012) and on In Re Fosamax, infra, is misplaced. The Court in In Re Fosamax relied on the rulings in both “Mensing (supra) and Bartlett (supra) [which] recognize that manufacturers have no control over the design or labeling of generic drugs”. The Court there found that “[s]hort of exiting the market… [the Plaintiff] failed to identify anything the Generic Defendants can do to reconcile their conflicting duties under state and federal law.” In Re Fosamax, 751 F.3d 150, 165 (3d Cir. 2014). This could not be further from the truth given the allegations before this Court. In fact, given the other efforts and misrepresentations made by Defendants; no label could effectively undo the damage they knowingly put into action. Defendants could have easily refrained from the unlawful conduct asserted in the Complaint. At the core of each of their arguments is the misconception that Plaintiffs are attempting to obviate the FDA’s labeling requirements. This case goes well beyond whether or not the Defendants properly labeled the Lexapro and/or Escitalopram. It has been discovered that they have not…which will also be part of the subject matter of the First Amended Complaint which Plaintiff’s seek to file. It is also noteworthy that Defendant TEVA is seeking to rely almost entirely upon this inapplicable line of cases which are made more inapplicable because they consider the standard of a Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 17 of 21 Page ID #:514 12 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 29 30 31 32 motion for summary judgment. Not a single case cited in their “chart” is an applicable opinion under FRCP Rule 12(b)(6). Unlike the cases chosen by Defendant TEVA, the current case specifically alleges voluntary affirmative conduct and a conspiracy undertaken by the manufacturers which well-exceeds the notion of standard labeling. The aggressive conduct designed to overtake their competitors and establish Lexapro/Escitalopram as the top SSRI’s exceeded the passive labeling activity that was the basis of any cases which were preempted. 3. The Third Cause of Action for Breach of Warranty is Not Pre-Empted. Again, the Complaint alleges that the Defendants took more assertive, aggressive and liability-imposing efforts rather than sticking to following the FDA’s labeling requirements and allowing medical professionals and patients to come to them. Paragraphs 58 and 59 set forth specific warranties which were made by the Defendants. They cannot now hide behind the shield of pre-emption and the ANDA for actions they took which exceeded the scope thereof. Congress nor the FDA have shown the intention to regulate the law of warranty when a company makes false promises to consumers. 4. The Fourth and Fifth Causes of Action (for Violations of California Consumers Laws) is Not Pre-Empted. For the same reasons set forth in Plaintiffs’ argument regarding the fraud claims (and above in the breach of warranty discussion); the pre-emption argument does not overcome the conduct alleged against these defendants. 5. The Sixth and Seventh Causes of Action for Negligence and Wrongful Death. Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 18 of 21 Page ID #:515 13 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 29 30 31 32 Similarly, these last claims cannot be overcome with an inapplicable pre- emption argument. The negligent and the wrongful conduct alleged in these causes of action is not limited to labeling. D. Notice Under California Civil Code Section 1782(a). Lastly, Defendant TEVA contends that the notice provisions of California Civil Code Section 1782(a) warrant dismissal of the Complaint. Clearly a letter to the Defendants after KK’s death would have no impact on the issues before this Court. The purpose of the notice requirement (along with the curability of any failure to provide the notice) is set forth in Morgan v. AT & T Wireless Servs., Inc., 177 Cal. App. 4th 1235, 1261, 99 Cal. Rptr. 3d 768, 789 (2009), where the Court ruled as follows: The federal district court cases upon which AT & T [Defendant] relies for its assertion that failure to comply with the notice requirement requires dismissal with prejudice fail to properly take into account the purpose of the notice requirement. That requirement exists in order to allow a defendant to avoid liability for damages if the defendant corrects the alleged wrongs within 30 days after notice, or indicates within that 30–day period that it will correct those wrongs within a reasonable time. (See, e.g., Meyer v. Sprint Spectrum L.P., supra, 45 Cal.4th at p. 642, 88 Cal.Rptr.3d 859, 200 P.3d 295; Kagan v. Gibraltar Sav. & Loan Assn., supra, 35 Cal.3d at p. 590, 200 Cal.Rptr. 38, 676 P.2d 1060.) A dismissal with prejudice of a damages claim filed without the requisite notice is not required to satisfy this purpose. Instead, the claim must simply be dismissed until 30 days or more after the plaintiff complies with the notice requirements. (emphasis added). Id. Given the impossibility of fulfilling the purpose of the notice requirements of the statute, Defendant TEVA’s argument fails. In any event, leave to Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 19 of 21 Page ID #:516 14 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 29 30 31 32 amend should be granted should this Court determine otherwise. E. Leave To Amend Under the applicable laws of the United States and the State of California, leave to amend a complaint is liberally granted and appropriate should the Court be so inclined to grant TEVA any relief at all. As stated in Schreiber Distributing v. Serv-Well Furniture, 806 F.2d 1393, 1401 (9th Cir. 1986): Fed.R.Civ.P. 15(a) provides, inter alia, that "a party may amend his pleading once as a matter of course at any time before a responsive pleading is served. . . ." We have stated that "`[a] motion to dismiss is not a "responsive pleading" within the meaning of the Rule. Neither the filing nor granting of such a motion before answer terminates the right to amend; an order of dismissal denying leave to amend at that state is improper. . . .'" Mayes, 729 F.2d at 607 (quoting Breier v. Northern California Bowling Proprietors' Association, 316 F.2d 787, 789 (9th Cir. 1963)). If a complaint is dismissed for failure to state a claim, leave to amend should be granted unless the court determines that the allegation of other facts consistent with the challenged pleading could not possibly cure the deficiency. Bonanno v. Thomas, 309 F.2d 320, 322 (9th Cir. 1962). Id. III. CONCLUSION Defendant TEVA’s selective reading and mischaracterization of the allegations in the Complaint and their reliance on inapposite cases which apply the standards for a motion for summary judgment are insufficient to warrant a dismissal under FRCP Rule 12(b)(6). In light of the arguments made, there is no basis for their motion to be granted….even if Plaintiffs did not desire to amend their Complaint. However, the Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 20 of 21 Page ID #:517 15 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 29 30 31 32 Complaint can easily be amended to address the more strict pleading requirements of federal court. For the foregoing reasons, it is respectfully requested that the Court deny the motion in its entirety. However, if the Court elects to grant any portion of the motion; leave to amend is respectfully requested and should be granted. DATED: September 21, 2017 Respectfully Submitted /s/ Michael S. Traylor Michael S. Traylor Attorney for Plaintiffs Case 5:17-cv-00922-MWF-DTB Document 63 Filed 09/21/17 Page 21 of 21 Page ID #:518