Stephanie Patton et al v. Forest Laboratories, LLC

REPLY in support of Motion NOTICE OF MOTION AND MOTION to Dismiss Plaintiffs' Second Amended Complaint for Damages 129

C.D. Cal.August 31, 2018

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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint Case No.: 5:17-cv-00922 KEVIN W. ALEXANDER (SBN: 175204) THOMAS WATSON (SBN: 227264) GORDON & REES LLP 633 W. Fifth Street, 52nd Floor Los Angeles, CA 90071 Telephone: (213) 576-5000 Facsimile: (213) 680-4470 kalexander@gordonrees.com twatson@gordonrees.com JOHN R. IPSARO (admitted pro hac vice) JENNIFER SNYDER HEIS (admitted pro hac vice) ULMER & BERNE LLP 600 Vine Street, Suite 2800 Cincinnati, OH 45202 Telephone: (513) 698-5104 Facsimile: (513) 698-5105 jipsaro@ulmer.com jheis@ulmer.com Attorneys for Defendants Allergan Sales, LLC & Allergan, Inc. UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA STEPHANIE PATTON and KENDRICK KNIGHTEN, Plaintiffs, vs. ALLERGAN, PLC., ALLERGAN, INC., FOREST LABORATORIES, INC., ACTAVIS, PLC, LUPIN PHARMACEU- TICALS, 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) Allergan Sales, LLC, and Allergan, Inc.’s Reply Memorandum in Sup- port of Its Motion to Dismiss Plain- tiffs’ Second Amended Complaint for Damages Date: September 17, 2018 Time: 10:00 a.m. Ctrm: 5A Judge Michael W. Fitzgerald Magistrate Judge David T. Bristow Complaint Filed: April 4, 2017 Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 1 of 18 Page ID #:2066 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint i Case No.: 5:17-cv-00922 TABLE OF CONTENTS I. INTRODUCTION ........................................................................................... 1 II. LAW AND ARGUMENT .............................................................................. 4 A. PLAINTIFFS DO NOT ALLEGE FACTS TO STATE A CLAIM FOR RELIEF PLAUSIBLE ON ITS FACE ............................................................. 4 1. Plaintiffs Do Not Allege an Inadequacy in the Labeling ........... 4 2. Plaintiffs Do Not Allege Causation ............................................ 7 3. Plaintiffs Do Not Allege Facts to Support a Request for Punitive Damages ....................................................................... 8 B. PLAINTIFFS’ UCL CLAIM DOES NOT SATISFY THE PLEADING REQUIREMENTS OF RULE 9(B) ................................................................ 9 C. FAILURE-TO-WARN CLAIMS DIRECTED AT PHARMACEUTICAL PRODUCTS ARE PREEMPTED BY FEDERAL LAW ................................... 10 III. CONCLUSION ............................................................................................. 12 Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 2 of 18 Page ID #:2067 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint ii Case No.: 5:17-cv-00922 TABLE OF AUTHORITIES Cases Adams v. I-Flow Corp., No. CV09-09550 R(SSx), 2010 WL 1339948 (C.D. Cal. Mar. 30, 2010) ............ 8 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ......................................................................................... 3, 11 Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) ......................................................................................... 3, 11 Bouncing Angels, Inc. v. Burlington Ins. Co., No. EDCV170015JGBSPX, 2017 WL 1294004 (C.D. Cal. Mar. 20, 2017) ........ 8 Cooper v. Pickett, 137 F.3d 616 (9th Cir. 1997) ................................................................................. 9 Dolin v. GlaxoSmithKline LLC, --- F.3d. ---, No. 17-3030, 2018 WL 4001208 (7th Cir. 2018) ............................. 2 Freedom Transp., Inc. v. Travelers Companies, Inc., No. EDCV16213JGBSPX, 2016 WL 7496731 (C.D. Cal. Mar. 24, 2016) .......... 8 In re: Celexa and Lexapro Marketing and Sales Practices Litig., 779 F.3d 34 (1st Cir. 2015) .................................................................................... 2 Kelley v. Corr. Corp. of Am., 750 F. Supp. 2d 1132 (C.D. Cal. 2010) ................................................................. 8 Mitchell v. Boehringer Ingelheim Pharms., No. 1:16-cv-02384-STA-egb, 2017 WL 5617473 (W.D. Tenn. Nov. 21, 2017) .. 2 Motus v. Pfizer Inc., 196 F. Supp. 2d 984 (C.D. Cal. 2001) ................................................................... 7 Sentinel Offender Servs., LLC v. G4S Secure Sols. (USA), Inc., No. SACV 14-298-JLS JPRX, 2014 WL 2511303 (C.D. Cal. June 3, 2014) ....... 9 Shah v. Forest Labs., Inc., No. 10 C 8163, 2015 WL 3396813 (N.D. Ill. May 26, 2015) ............................... 7 Temple v. Velcro USA, Inc., 148 Cal. App. 3d 1090 (1983) ............................................................................... 7 Timmons v. Linvatec Corp., 263 F.R.D. 582 (C.D. Cal. 2010) ........................................................................... 8 Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644 (2016) ............................................................................... 2, 7 Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 3 of 18 Page ID #:2068 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint iii Case No.: 5:17-cv-00922 Rules Federal Rules of Civil Procedure Rule 9 ..................................................................................................................... 9 Regulations 21 Code of Federal Regulations Section 201.57 ..................................................................................................... 12 21 Code of Federal Regulations Section 314.70 ................................................................................................. 1, 12 Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 4 of 18 Page ID #:2069 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 1 Case No.: 5:17-cv-00922 I. INTRODUCTION Plaintiffs’ Second Amended Complaint, like their previous versions, is a study in vague, conclusory statements and legal conclusions ‒ none of which state a viable claim sufficient to withstand scrutiny. Instead of adding the factual speci- ficity and detail the Court repeatedly has told plaintiffs’ counsel he requires, plain- tiffs rely on the same conclusory allegations about events remote in time and unre- lated to plaintiffs’ claims. Plaintiffs still have not pled a claim plausible on its face and still have not addressed salient facts fatal to their claims: • FACT: The applicable Lexapro label specifically warned in the Highlights section ‒ in a boxed warning ‒ of “[i]ncreased risk of sui- cidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders.” (Lexapro label, approved October 2014, attached as Exhibit A to defendants’ motion.) • FACT: The applicable Lexapro label included a longer, more- detailed warning in the Full Prescribing Information (“FPI”) ‒ again in a boxed warning ‒ that “[a]ntidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidali- ty) in children, adolescents, and young adults in short-term stud- ies of major depressive disorder (MDD) and other psychiatric dis- orders. Anyone considering the use of Lexapro or any other anti- depressant in a child, adolescent, or young adult must balance this risk with the clinical need.” (Id.) • FACT: The risk of teenage suicidality was addressed at length in the Warnings and Precaution sections in both Highlights and FPI. (Id.) • FACT: An NDA holder may not, under any circumstances, make any change to the Highlights section of the label without prior FDA approval. See 21 C.F.R. §314.70(b)(2)(v)(C). • FACT: Changes to a pharmaceutical product’s label made using the Food and Drug Administration’s (“FDA”) “changes being effect- ed” (“CBE”) procedure must be based on “newly acquired infor- mation” and “sufficient evidence of a causal association with the drug.” See 21 C.F.R. §314.70 (c)(6)(iii)(A). • FACT: To state a non-preempted claim involving a pharmaceuti- cal product’s purported risks, plaintiffs must identify “newly acquired information” that would have supported submission of a CBE to Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 5 of 18 Page ID #:2070 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 2 Case No.: 5:17-cv-00922 change the product’s label. See Dolin v. GlaxoSmithKline LLC, --- F.3d. ---, No. 17-3030, 2018 WL 4001208 (7th Cir. 2018); In re: Celexa and Lexapro Marketing and Sales Practices Litig., 779 F.3d 34, 37 (1st Cir. 2015); Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644, 673-74 (2016); Mitchell v. Boehringer Ingelheim Pharms., No. 1:16-cv-02384-STA-egb, 2017 WL 5617473 (W.D. Tenn. Nov. 21, 2017). Plaintiffs must address those facts and cannot ignore or avoid them by cavalierly proclaiming that the claims alleged are not warning-based claims, but instead are amended versions of the “claims” the Court afforded plaintiffs an opportunity to replead.1 Plaintiffs’ description of their claims does not carry the day; it is the sub- stance that matters. And, as was true of their prior complaints, the Second Amend- ed Complaint is replete with warning-based allegations. A small sampling pro- vides the flavor of plaintiffs’ allegations. (See, e.g., Second Amended Complaint, ¶34 (alleging defendants “made material omissions and misrepresentations” ‒ no- tably the allegation is virtually identical to that which appeared at ¶34 of plaintiffs’ First Amended Complaint2); ¶36 (alleging defendants “concealed harmful infor- mation” and misrepresented side effects ‒ virtually identical to ¶36 of plaintiffs’ First Amended Complaint); ¶38 (alleging defendants acted to preclude distribution of information of allegedly harmful side effects ‒ virtually identical to ¶38 of plaintiffs’ First Amended Complaint); ¶39 (alleging defendants “concealed and misrepresented” side effects ‒ virtually identical to ¶39 of plaintiffs’ First Amend- ed Complaint); ¶41 (alleging “Pharma Defendants” did not “properly warn” ‒ vir- tually identical to ¶41 of plaintiffs’ First Amended Complaint); ¶42 (alleging “Pharma Defendants” concealed and misrepresented risk ‒ virtually identical to 1 The Court granted plaintiffs leave to amend their “strict products liability, fraud, negli- gence, UCL, breach of warranty, and wrongful death claims.” (Dkt. 115, p. 43.) Plaintiffs chose not to amend or replead the strict products liability, fraud, or breach of warranty claims. (See, generally, Second Amended Complaint (Dkt. 124).) 2 The only difference is that plaintiffs substituted “Defendants (jointly and severally) for “the Pharma Defendants” and omitted references to generic escitalopram. Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 6 of 18 Page ID #:2071 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 3 Case No.: 5:17-cv-00922 ¶42 of plaintiffs’ First Amended Complaint); ¶44 (alleging defendants were re- quired to provide “stronger warnings” ‒ virtually identical to ¶44 of plaintiffs’ First Amended Complaint); ¶46 (alleging “Pharma Defendants” did not provide infor- mation of alleged risk ‒ virtually identical to ¶46 of plaintiffs’ First Amended Complaint); etc.)3 Plaintiffs disingenuously represent that their “claims” “are separate and apart from the dismissed claims and are sufficient as pled.” (Plaintiffs’ Opp., p. 4.) They are not. The titles of the counts in their Second Amended Complaint may have changed, but the lion’s share of the allegations have not and those that have do not satisfy the pleading requirements any more than plaintiffs’ last set of allega- tions did. On that aspect, plaintiffs ignore salient legal requirements: • FACT: “Labels and conclusions” are not sufficient to satisfy plaintiffs’ pleading requirements. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). • FACT: “Plausibility” requires more than a “sheer possibility that a defendant has acted unlawfully” or the “mere possibility of miscon- duct,” and a complaint that includes allegations that are “merely con- sistent with” liability “stops short of the line between possibility and plausibility of ‘entitlement to relief.’” Ashcroft v. Iqbal, 556 U.S. 662, 678-79 (2009) (citing Twombly, 550 U.S. at 557). • FACT: “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements,” will not pass muster under Twombly. Iqbal, 556 U.S. at 678 (citing Twombly, 550 U.S. at 555). Plaintiffs suggest that the Court let them turn back the clock, ignore the applicable Lexapro package insert, and instead rely on vague, conclusory assertions that al- legedly illegal conduct from over a decade before the prescription in this case (which plaintiffs misappropriated from lawsuits filed more than a decade ago) are sufficient to withstand dismissal. Plaintiffs’ suggestion is sheer sophistry. In the 3 Those allegations are incredibly similar to those noted by the Court in its May 10 Order as encapsulating the gist of plaintiffs’ claims – that notwithstanding the long-present suicide warnings, defendants somehow misled the public about suicide-related risks of Lexapro. (Dkt. 115, pp. 12-13.) Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 7 of 18 Page ID #:2072 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 4 Case No.: 5:17-cv-00922 end, as before, plaintiffs do not comply with the pleading requirements and do not state any viable claim plausible on its face. Plaintiffs’ Second Amended Com- plaint should be dismissed with prejudice. II. LAW AND ARGUMENT At the outset, defendants wish to be clear and resolve plaintiffs’ apparent confusion. First, defendants contend all plaintiffs’ claims are invalid. (See Plain- tiffs’ Opp., p. 5 (stating “it [is] difficult to follow … which claims [defendants] be- lieve are valid or invalid).) Second, defendants did, and continue to, challenge plaintiffs’ first and second causes of action. (Id., p. 14.) Third, defendants do not, and have not, conceded that any claim plaintiffs asserted in their Second Amended Complaint “will go forward.” (Id., p. 14.) Fourth, as plaintiffs’ counsel surely is aware, it is black-letter law that “causation” is an element of every cause of action and a failure to allege causation, therefore, impacts every count in the complaint and every claim made. Hence, plaintiffs’ accusation that defendants’ motion “is procedurally flawed and unintelligible as it does not assert specific causes of action which it seeks to attack” (id., p. 5) is meritless. Fifth, a request for punitive dam- ages is not a “cause of action,” it is in plaintiffs’ “prayer for relief,” which does not specify to which cause of action it may be applicable. Instead, plaintiffs merely “pray[] [for] judgment against Defendants [for] “allowable and applicable punitive damages ….” (Second Amended Complaint, Prayer for Relief, p. 54.) Plaintiffs’ failure to allege facts to support an award of punitive damages is ample grounds for defendants to ask this Court to dismiss their request. Having, hopefully, dispelled plaintiffs’ confusion, defendants turn to the grounds warranting dismissal of plaintiffs’ Second Amended Complaint. A. PLAINTIFFS DO NOT ALLEGE FACTS TO STATE A CLAIM FOR RELIEF PLAUSIBLE ON ITS FACE 1. Plaintiffs Do Not Allege an Inadequacy in the Labeling Plaintiffs assert that their “claims are clearly different” from the “failure to Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 8 of 18 Page ID #:2073 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 5 Case No.: 5:17-cv-00922 warn” claims this Court already dismissed. (Plaintiffs’ Opp., p. 6.) Plaintiffs nev- er explain how they are different (and the already-noted virtually identical para- graphs of this complaint as compared to the last indicate otherwise). Instead, they say: “Not only did the Court differentiate these claims (by allowing leave to amend them), but the SAC sufficiently sets forth the basis of such claims.” (Id.) Plaintiffs, however, do not identify the “basis” to which they refer. Perusal of the Counts in plaintiffs’ Second Amended Complaint refutes any argument that the al- legations are not based on an alleged failure to warn. Count one is titled “Negligence” and it is “Based Upon the Pre-Allergan Lawsuits Conduct.” (Second Amended Complaint, Dkt. 124, p. 26.) Plaintiffs never define “Pre-Allergan Lawsuits Conduct,” but refer to a time before the “Lexapro Lawsuits,” which were lawsuits based on alleged conduct in the late 1990s and early 2000s – over a decade before Kennadi was prescribed or took Lexapro or its generic equivalent in 2016. In that Count, plaintiffs allege that de- fendants had a “duty to provide relevant, truthful and accurate information to phy- sicians and health care providers … so that those professionals would have the most up-to-date and relevant information about drugs before prescribing them.” (Second Amended Complaint, ¶57; see also ¶58 (same allegation except asserting (wrong as it is legally) that the duty was to provide the information to the patient).) Then in paragraphs 60 through 66, plaintiffs again turn back the clock and complain about alleged conduct that occurred more than a decade before Kennadi first was prescribed or took Lexapro or escitalopram. Plaintiffs try to bring their allegation into the present with the conclusory statement that “Defendants contin- ued in their Lexapro Marketing Scheme and their Illegal Conduct up to and beyond the times in 2016 when Kennadi was prescribed and took Lexapro.” (Id., ¶66.) Then they claim it was due to the “Lexapro Marketing Scheme” that Kennadi’s physician elected to prescribe Lexapro (id., ¶67), contending defendants did not disclose the risk of suicidality associated with the product’s use (id., ¶¶68, 70-74). Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 9 of 18 Page ID #:2074 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 6 Case No.: 5:17-cv-00922 Plaintiffs’ second Count is titled “Negligence” “Based Upon the Post Aller- gan Lawsuits Conduct and the CIA.” (Second Amended Complaint, p. 34.) Throughout the paragraphs of the second count, plaintiffs allege that defendants did not “remedy,” “dispel,” “change,” or “correct,” alleged misinformation or “in- form” the medical community that Lexapro posed a risk of suicides for teenagers and adolescents. (E.g., id., ¶¶76-80.) Then, as they do in their first Count, they fall back in time and rely on decade-old alleged conduct trying to bring it into the fu- ture through an allegation that defendants “continu[ed] in such Illegal Conduct without enhancing the warnings reasonably required to inform the medical profes- sion about the newly discovered risks (alleged hereinabove) applicable to teenagers and adolescents taking Lexapro.” (Id., ¶83a, see also id., ¶93.) They go a step fur- ther in their second count and attempt to incorporate the already-dismissed allega- tions regarding the Corporate Integrity Agreement between Forest Laboratories and the government.4 (Id., ¶¶84-89, 94-95.) When parsed, it is clear that plaintiffs’ claims are all about a purported fail- ure by defendants to adequately warn of the risk of teenage suicidality. If their claims are about anything else, plaintiffs never describe what that is or how it re- lates to Kennadi’s suicide. That conclusion is reinforced in plaintiffs’ Third Count (alleging a violation of California’s Unfair Competition Law (“UCL”)) and Fourth Count (wrongful death), both of which outright allege defendants did not provide sufficient information regarding the risk of teenage suicidality. (See id., pp. 47-54.) 4 Again choosing to ignore the Court’s May 10 Order, which accurately described Plain- tiffs’ RICO and third-party beneficiary claims as “quite obviously specious.” (Dkt. 115, p. 22.) A few facts are worth reinforcing: The CIA began in 2010 and expired in 2015 before Kennadi was prescribed Lexapro. (See CIA attached as Exhibit A to Plaintiffs’ First Amended Com- plaint, Dkt. 85.) In March 2009, FDA approved Lexapro to treat depression in adolescents as young as 12, notwithstanding the already-present extensive adolescent suicidality warnings. (See Dkt. 129-1 at fn. 5 with a link to the FDA website approval history for Lexapro and judicial no- tice citations.) The fact that Lexapro is approved for use in patients as young as 12 is stated in the summary of the boxed warning in Highlights section of the Lexapro package insert, and in the boxed warning in the full prescribing information. (See Dkt. 129-1, pp. 7-8.) Plaintiffs ig- nore that approval and label language because they render plaintiffs’ ill-defined allegations of an improper “Lexapro marketing scheme” even more frivolous (if that is even possible). Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 10 of 18 Page ID #:2075 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 7 Case No.: 5:17-cv-00922 Notably missing throughout plaintiffs’ Second Amended Complaint is any recognition of the existence of the applicable Lexapro label; the label that accom- panied every shipment of the product; the label that is directed at physicians and the healthcare community5; the label that includes specific, detailed warnings of the risk of teenage suicidality, not once, but twice in bold print enclosed in a black box and then again in both Highlights and Full Prescribing Information in the Warnings and Precautions section. So, yes, to state a facially plausible claim, plaintiffs must identify some inadequacy in those warnings and not merely repeat conclusory, vague allegations of some ill-defined current (or decade-old) conduct. It is as though plaintiffs believe that if they ignore the existence of the applicable Lexapro label, this Court will too and permit their claims to survive. Without any allegation as to how the detailed suicidality warnings developed by the FDA for antidepressants as a class of drugs are inadequate, plaintiffs’ claims cannot survive. See Utts v. Bristol-Meyers Squibb Co., 251 F. Supp. 3d 644, 672- 74 (2016) (under California law an adequate warning is a defense that is a question of law for the court where extrinsic evidence is not necessary)(citing Temple v. Velcro USA, Inc., 148 Cal. App. 3d 1090 (1983)); Shah v. Forest Labs., Inc., No. 10 C 8163, 2015 WL 3396813 (N.D. Ill. May 26, 2015)(Lexapro’s suicide warn- ings are based on “FDA findings and advice” and plaintiff cites nothing to show warnings were inadequate). Because plaintiffs do not articulate how the lengthy and detailed suicide warnings FDA drafted are deficient, plaintiffs’ warning-based claims fail to state a claim and must be dismissed. 2. Plaintiffs Do Not Allege Causation Plaintiffs contend that they have alleged causation in various paragraphs of 5 See Motus v. Pfizer Inc., 196 F. Supp. 2d 984, 990 (C.D. Cal. 2001)(“California follows the learned intermediary doctrine, which states that in the case of prescription drugs, the duty to warn runs to the physician, not to the patient” and “a manufacturer discharges its duty to warn if it provides adequate warnings to the physician ... regardless of whether the warning reaches the patient”). Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 11 of 18 Page ID #:2076 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 8 Case No.: 5:17-cv-00922 their Second Amended Complaint. (Plaintiffs’ Opp., p. 13.) Those paragraphs, however, do not offer any facts connecting Lexapro to Kennadi’s death. Plaintiffs allege only that Kennadi was given “that dose” on March 22, 2016. (Second Amended Complaint, ¶69.) They do not, however, tie “that dose” in any way, shape, or form to Kennadi’s behavior more than two months later. That absence alone warrants dismissal of the complaint. See Timmons v. Linvatec Corp., 263 F.R.D. 582, 584-85 (C.D. Cal. 2010) (dismissing complaint where plaintiff did not specify defendant’s product caused injury); Adams v. I-Flow Corp., No. CV09- 09550 R(SSx), 2010 WL 1339948, *3 (C.D. Cal. Mar. 30, 2010) (same). Plaintiffs’ conclusory allegations that some unidentified conduct set in motion a series of events leading to the prescription for Lexapro given to Kennadi does not satisfy plaintiffs’ burden of alleging causation; i.e., how a single dose of Lexapro over two months before Kennadi’s suicide led to Kennadi’s tragic death. 3. Plaintiffs Do Not Allege Facts to Support a Request for Pu- nitive Damages Plaintiffs’ response to defendants’ argument that there are no facts alleged to support a request for punitive damages is scant. First, plaintiffs suggest defendants were required to file a motion to strike rather than seeking dismissal of the request. They cite no support for that assertion. Then, plaintiffs contend their allegations of decade-old alleged conduct support their request. Yet, those allegations are vague and conclusory without any connection to plaintiffs or Kennadi’s physicians or health-care providers. The other allegations plaintiffs include are boilerplate and insufficient to withstand dismissal. See Kelley v. Corr. Corp. of Am., 750 F. Supp. 2d 1132, 1147-48 (C.D. Cal. 2010); Bouncing Angels, Inc. v. Burlington Ins. Co., No. EDCV170015JGBSPX, 2017 WL 1294004, *4 (C.D. Cal. Mar. 20, 2017) (dismissing punitive damages request due to plaintiff’s failure to plead facts of malice, fraud, or oppression); Freedom Transp., Inc. v. Travelers Companies, Inc., No. EDCV16213JGBSPX, 2016 WL 7496731, *9 (C.D. Cal. Mar. 24, 2016) (dis- Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 12 of 18 Page ID #:2077 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 9 Case No.: 5:17-cv-00922 missing punitive damages request where conclusory allegations lacked correspond- ing factual basis); Sentinel Offender Servs., LLC v. G4S Secure Sols. (USA), Inc., No. SACV 14-298-JLS JPRX, 2014 WL 2511303, *9 (C.D. Cal. June 3, 2014) (dismissing punitive damages request where complaint lacked factual support). Given plaintiffs have not advanced allegations sufficient to state a claim plausible on its face, those same allegations do not rise to the level necessary to support a re- quest for punitive damages. B. PLAINTIFFS’ UCL CLAIM DOES NOT SATISFY THE PLEADING RE- QUIREMENTS OF RULE 9(B) Plaintiffs accuse defendants of not “bothering to specify what elements and/or information is missing” from their UCL claim. (Plaintiffs’ Opp., p. 15.) Defendants were very clear and specific (as is the law) that plaintiffs are required to plead “the who, what, when, where, and how” of the allegedly fraudulent con- duct. Fed. R. Civ. P. 9(b); Cooper v. Pickett, 137 F.3d 616, 627 (9th Cir. 1997). In reality, plaintiffs are on a fishing expedition as demonstrated in their response: “[E]nough information is presented to raise a reasonable expectation that discovery will reveal evidence of the actual documents utilized by the Defendants.” (Id.) That is not the standard. Plaintiffs must allege the requisite elements ‒ who, what, where, when, and how. They have not. Moreover, while plaintiffs assert that their current UCL claim is “different and allege[s] different facts” than their previous claim, (Plaintiffs’ Opp., Dkt. 130, p. 16), they do not delineate those differences for defendants or the Court. Instead, they offer the vague statement that the claim is “based on the voluntary, affirma- tive conduct of the Defendants to undermine the warnings.” (Id.) The who, what, where, when, and how is, again, missing. Fed. R. Civ. P. 9(b); Cooper v. Pickett, 137 F.3d 616, 627 (9th Cir. 1997). Just as in plaintiffs’ previous complaint, they do not identify who “made misleading statements, the specific content of the mis- leading statements, when or how the misleading statements were made, who heard Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 13 of 18 Page ID #:2078 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 10 Case No.: 5:17-cv-00922 or saw the misleading statements, or why the statements were misleading.” (Dkt. 73, p. 9; Dkt. 115, pp. 35-6.) As before, the claim must be dismissed. C. FAILURE-TO-WARN CLAIMS DIRECTED AT PHARMACEUTICAL PRODUCTS ARE PREEMPTED BY FEDERAL LAW Plaintiffs begin their response to defendants’ preemption defense by assert- ing that “causes of action for breach of warranty, intentional fraud and misrepre- sentation of a material fact by either a false representation or concealment, and conspiracy are not included within the preemptive reach of a federal act which sets forth a duty to warn.” (Plaintiffs’ Opp., Dkt. 130, p. 16.) Here’s the rub. Whether that statement has any credence (which it does not as the U.S. Constitution and the Supremacy Clause do not concern themselves with the theory of liability, but in- stead the supremacy of federal law over all state laws), it is irrelevant. Plaintiffs have not alleged a breach of warranty, fraud, or conspiracy claim. Their counts are for negligence, violation of the UCL, and wrongful death. Period. Then, plaintiffs again proclaim “the current claims in the SAC are different and allege different facts.” (Id.) According to plaintiffs, the SAC “is not based on a failure-to-warn theory, it is based on the voluntary, affirmative conduct of the Defendants to undermine the warning.” (Id.) They continue by saying that “the Defendants could have included the warning and repeated it to the medical com- munity … in fact, they could have included the warning and said nothing. Howev- er, they chose to undermine the warning and defraud the medical professionals who prescribe Lexapro. Preemption does not extend to such conduct.” (Id.) Plaintiffs’ argument is quite cryptic. What “warning”? The one that advises that there is a risk of suicidality for teenagers and adolescents taking Lexapro that appears in bold, boxed warnings, and in lengthy detail in the Warnings and Precau- tions section of the label shipped with all Lexapro? The one available to physi- cians for a decade before Lexapro was prescribed for Kennadi? The one drafted by FDA and discussed in the national press and by medical associations in their jour- Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 14 of 18 Page ID #:2079 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 11 Case No.: 5:17-cv-00922 nals? That warning – the one quoted and cited in defendants’ opening memoran- dum? Notably, plaintiffs never dispute that the applicable Lexapro label included the exact warning FDA required, which defendants identified in their opening memorandum. Nor do plaintiffs make any effort in their Second Amended Complaint to al- lege or explain how Allergan managed to “undermine” the warning that accompa- nied its Lexapro. Such a bald, conclusory (not to mention outrageous and false) allegation must be supported by facts that show the allegation is plausible. Iqbal, 556 U.S. at 678-79 (citing Twombly, 550 U.S. at 557). As discussed above in foot- note 4, Lexapro was approved for treatment of depression in adolescent patients as young as 12 in 2009, seven years before the prescription in this case. Plaintiffs’ desire to distance themselves from the existing warning is not dif- ficult to understand as it bars their claims and mandates dismissal of their lawsuit. There is, however, no getting around that result. The label includes a specific, detailed, lengthy warning related to the risks of teenage suicidality associated with Lexapro use. The risk of teenage suicidality is the entire (and sole) underlying basis of plaintiffs’ lawsuit and, while plaintiffs as- sert that they identify “newly acquired information” that would have supported submission of a CBE to change the Lexapro label (Plaintiffs’ Opp., p. 16), in reali- ty they do no more than repeat that phrase over and over and over again without ever specifying or identifying the “newly acquired information.” Plaintiffs’ task is to identify “newly acquired information” defendants possessed (which FDA did not) post-dating the last approved Lexapro label (October 2014) that would have permitted defendants to change the existing suicide warning. That, they have not done and cannot do. Yet, notwithstanding there is no “newly acquired information” to support submission of a CBE, the fact that the label cannot be changed without FDA’s pri- or approval defeats plaintiffs’ claims in any event. As explained in defendants’ Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 15 of 18 Page ID #:2080 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 12 Case No.: 5:17-cv-00922 opening memorandum, defendants cannot unilaterally or independently change the Highlights section because FDA’s regulations require pre-approval for any and all changes to that section. See 21 C.F.R. §314.70 (b)(2)(v)(C). In turn, any change to the FPI section that necessitates a corresponding change to Highlights, also cannot be changed independently. Finally, Highlights must contain a list of substantive changes to the Indications and Usage and the Warnings and Precautions sections of the FPI approved by FDA or authorized under 21 C.F.R. §314.70. The list must in- clude “each section’s identifying number and the date (month/year) on which the change was incorporated in labeling.” The labeling sections are to be listed in the order in which they appear in the FPI and must be listed in Highlights for at least 1 year after the date of the labeling change. 21 C.F.R. §201.57(a)(5). Again, all changes to Highlights require pre-approval. Plaintiffs never address those requirements or acknowledge their existence. Plaintiffs’ never argue that preemption does not follow as a result of those re- quirements, despite knowing that the Court already has concluded that preemption applies. (Dkt. 115, pp. 30-31.)6 Ignoring those requirements doesn’t make them go away and their existence is determinative of the claims plaintiffs attempt to as- sert against defendants. Those claims are preempted and must be dismissed. III. CONCLUSION Kennadi’s death was a terrible tragedy. No one disputes that. But this law- suit has been baseless from the start. Making unfounded and false outrageous alle- gations while ignoring undisputed dispositive facts and legal realities is an abuse of / / / / / / / / / 6 The Court also wrote “if Plaintiffs cannot plausibly (and in a manner consistent with Rule 11) construct a non-preempted claim, the Court urges Plaintiffs not to try.” Plaintiffs’ counsel ignored the Court’s admonition, just as he continuously ignores the regulatory require- ments and their preemptive effect. Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 16 of 18 Page ID #:2081 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 13 Case No.: 5:17-cv-00922 the legal system this Court should not countenance. Dismissing the lawsuit with prejudice is a good first step in rectifying that abuse. Dated: August 31, 2018 GORDON & REES LLP By:/s/Thomas R. Watson Kevin W. Alexander Thomas R. Watson Attorneys for Defendant Allergan Sales, LLC, and Allergan, Inc. Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 17 of 18 Page ID #:2082 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 Allergan Sales, LLC, and Allergan Inc.’s Reply Memorandum in Support of Their Motion to Dismiss Plaintiffs’ Second Amended Complaint 14 Case No.: 5:17-cv-00922 CERTIFICATE OF SERVICE I am a resident of the State of California, over the age of eighteen years, and not a party to the within action. My business address is: Gordon & Rees LLP 101 W. Broadway, Suite 2000, San Diego, CA 92101. On August 31, 2018, I served the foregoing document entitled: Allergan Sales, LLC, and Allergan, Inc.’s Reply Memorandum in Support of Its Motion to Dismiss Plaintiffs’ Second Amended Complaint for Damages by electronic service through the CM/ECF System which automatically generates of Notice of Electronic Filing (“NEF”) and is sent by e- mail to all CM/ECF Users who have appeared in the case in this Court. Service with this NEF will constitute service pursuant to Federal Rules of Civil Procedure. I declare under penalty of perjury under the laws of the United States of America that the above is true and correct. Executed on August 31, 2018 at San Diego, California. Sylvia Durazo Case 5:17-cv-00922-MWF-DTB Document 133 Filed 08/31/18 Page 18 of 18 Page ID #:2083