Orr v. Bristol-Myers Squibb Co et al

Brief/Memorandum in Support

N.D. Tex.September 6, 2016

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS DALLAS DIVISION BEVERLY KAYE GRAHAM ORR, as Executrix of the Estate of Robin Orr and Individually, Plaintiff, v. BRISTOL-MYERS SQUIBB CO. and PFIZER INC., Defendants. § § § § § § § § § § § § § CIVIL ACTION NO. 3:16-cv-00681-B HONORABLE JANE J. BOYLE DEFENDANTS BRISTOL-MYERS SQUIBB COMPANY AND PFIZER INC.’S MEMORANDUM IN SUPPORT OF MOTION TO DISMISS PLAINTIF F’S FIRST AMENDED COMPLAINT PURSUANT TO FED R. CIV. P. 12(b)(6) Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 1 of 34 PageID 830 TABLE OF CONTENTS Page(s) i PRELIMINARY STATEMENT .......................................................................................... 1 LEGAL STANDARD FOR A MOTION TO DISMISS ........................................................... 6 ARGUMENT AND AUTHORITIES ................................................................................... 7 I. Texas Substantive Law Applies to This Case .............................................................. 7 II. Plaintiff’s Claims Are Foreclosed by Texas and Federal Law. ........................................ 9 A. The Texas Preemption Statute Applies to All Products Liability Claims Based on an Alleged Failure to Warn. .......................................................... 9 B. Under the Texas Preemption Statute, There Is a Rebuttable Presumption that Defendants Are Not Liable for Any Alleged Failure to Warn.. .......................... 10 C. Plaintiff’s Failure to Warn Claims Are Not Saved by the Texas Savings Clause. ...................................................................................................... 10 III. Plaintiff’s Design Defect Claims Fail as a Matter of Law. ............................................14 A. Comment k Bars Plaintiff’s Non-Warnings-Based Strict Liability Design Defect Claims................................................................................................. 14 B. Plaintiff Fails to Satisfy the Elements of a Strict Liability or Negligent Design Defect Claim.. ........................................................................................... 16 IV. Plaintiff’s Warranty Claims Fail as a Matter of Law. .................................................18 V. Plaintiff’s “Fraud/Fraudulent Concealment” Claim Fails as a Matter of Law. ...............20 A. Plaintiff’s Fraud Claims Are Barred by the Texas Preemption Statute.. ............ 20 B. Plaintiff’s Fraud Claims Are Not Pled with the Particularity Required Under Rule 9(b).. ........................................................................................... 21 C. Statements in Documents Identified by Plaintiff Are N ither False Nor Relevant to Her Litigation Claims. .............................................................. 22 VI. Plaintiff’s Loss of Consortium, Wrongful Death, and Survival Action Theories Fail Because They Are Derivative of Plaintiff’s Other Claims. .............................................25 CONCLUSION ................................................................................................................. 25 Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 2 of 34 PageID 831 TABLE OF AUTHORITIES Page(s) ii CASES Am. Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420 (Tex. 1997) ...............................................................................................17 Anderson v. Abbott Laboratories, No. 3:11–CV–1825–L, 2012 WL 4512484 (N.D. Tex. Sep. 30, 2012) .............................12, 13 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ........................................................................................................6 Barragan v. Gen. Motors LLC, CV No. 4:14-CV-93, 2015 WL 5734842 (W.D. Tex. Sept. 30, 2015) ....................................19 Barragan v. Gen. Motors LLC, No. SA-15-CV-854, 2016 WL 3519675 (W.D. Tex. June 22, 016) ......................................17 Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) ..........................................................................................2 Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) ........................................................................................................6 Brockert v. Wyeth Pharms., Inc., 287 S.W.3d 760 (Tex. App. 2009) ................................................................................16 Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) ............................................................................................5, 11, 13 Cardoni v. Prosperity Bank, 805 F.3d 573 (5th Cir. 2015) ..........................................................................................7 Caterpillar, Inc. v. Shears, 911 S.W.2d 379 (Tex. 1995) .........................................................................................16, 17 Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex. App.—Corpus Christi 2010, pet. granted), rev’d in part on other grounds, Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012) ..............................15 Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012) .................................................................................................9 Conklin v. Novartis Pharms. Corp., Civ. A. No. 9:11CV-178, 2012 WL 4127301 (E.D. Tex. Sept. 18, 2012) ..........................5, 18 Cooper Tire & Rubber Co. v. Mendez, 204 S.W.3d 797 (Tex. 2006) ...............................................................................................14 Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 3 of 34 PageID 832 TABLE OF AUTHORITIES Page(s) iii Cooper v. Pfizer, Inc., CIV. A. No. H-14-3705, 2015 WL 2341888 (S.D. Tex. May 13, 2015) ......................... passim Del Valle v. PLIVA, Inc., CIV. No. B-11-113, 2012 WL 4747259 (S.D. Tex. Sept. 12, 2012) .......................................13 Del Valle v. Qualitest Pharms. Inc., CIV. No. B-11-113, 2012 WL 2899406 (S.D. Tex. June 22, 2012) ....................................9, 11 Denman by Denman v. Snapper Div., 131 F.3d 546 (5th Cir. 1998) ..........................................................................................8 Eckhardt v. Qualitest Pharms. Inc., 858 F. Supp. 2d 792 (S.D. Tex. 2012) .........................................................................13 Enpro Sys., Ltd. v. Namasco Corp., 382 F. Supp. 2d 874 (S.D. Tex. 2005) .........................................................................19 Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011) ..........................................................................................2 Gaona v. Garland Surgicare Partners, Ltd., No. 05-15-00645-CV, 2016 WL 4189343 (Tex. App. Aug. 8, 2016) .....................................20 Garrett v. Hamilton Standard Controls, Inc., 850 F.3d 253 (5th Cir. 1988) ........................................................................................17 Geisler v. Texas Commerce Bank, No. 05-91-01148-CV, 1993 WL 530315 (Tex. App. Dec. 21, 1993), writ denied (July 28, 1994) .............................................................................................................................23 Gerber v. Hoffmann-LaRoche Inc., 392 F. Supp. 2d 907 (S.D. Tex. 2005) ...............................................................5, 15, 17 Gonzalez v. Bayer Healthcare Pharms., Inc., 930 F. Supp. 2d 808 (S.D. Tex. 2013) .........................................................................13 Grosskopf v. Chrysler Grp. LLC, No. A-14-CA-801, 2015 WL 6021851 (W.D. Tex. Oct. 14, 2015) .......................................7, 8 Hackett v. G.D. Searle & Co., 246 F. Supp. 2d 591 (W.D. Tex. 2002)........................................................................15 Hendricks v. Ford Motor Co., No. 4:12CV71, 2012 WL 7956426 (E.D. Tex. Aug. 24, 201 ) ..............................................25 Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 4 of 34 PageID 833 TABLE OF AUTHORITIES Page(s) iv Hoffman v. AmericaHomeKey, Inc., 23 F. Supp. 3d 734 (N.D. Tex. 2014) .................................................................................21 Holland v. Hoffman-LaRoche, Inc., No. 3-06-CV-1298, 2007 WL 4042757 (N.D. Tex. Nov. 15, 2007) .................................14, 15 Huddy v. Fruehauf Corp., 953 F.2d 955 (5th Cir. 1992) ..........................................................................................7 In re Celexa & Lexapro Mktg. & Sales Prac. Litig., 779 F.3d 34 (1st Cir. 2015) .........................................................................................3, 5 In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795 (E.D. Tex. 2002) ...........................................................................9 Jackson v. Wyeth LLC, No. 2:12-cv-196, 2015 WL 363513 (S.D. Tex. Jan. 27, 2015)................................................13 Johnson v. TDS Erectors, Inc., 426 F. App’x 241 (5th Cir. 2011) ..................................................................................25 Koenig v. Purdue Pharma Co., 435 F. Supp. 2d 551 (N.D. Tex. 2006) ....................................................................6, 25 KPMG Peat Marwick v. Harrison Cnty. Hous. Fin. Corp., 988 S.W.2d 746 (Tex. 1999) ...............................................................................................20 Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014) ..............................................................................9, 11, 12 Lochinvar Corp. v. Meyers, 930 S.W.2d 182 (Tex. App.-Dallas 1996) ..........................................................................19 Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012) ........................................................................5, 11, 12, 13 Lormand v. US Unwired, Inc., 565 F.3d 228 (5th Cir. 2009) ......................................................................................2, 6 Machete Prods., L.L.C. v. Page, 809 F.3d 281 (5th Cir. 2015) ..........................................................................................6 Massa v. Genentech Inc., CIV. A. No. H-11-70, 2012 WL 956192 (S.D. Tex. Mar. 19, 2012) ..........................16, 18, 19 Massey v. Novartis Pharms. Corp., 46 F. Supp. 3d 688 (W.D. Tex. 2014)...........................................................................15, 19 Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 5 of 34 PageID 834 TABLE OF AUTHORITIES Page(s) v McAndrews v. C.R. Bard, Inc., CIV. A. No. H-14-2504, 2015 WL 2089432 (S.D. Tex. May 5, 2015) ...................................17 McKay v. Novartis Pharm., 751 F.3d 694 (5th Cir. 2014) ................................................................................5, 8, 19 McKay v. Novartis Pharms., 934 F. Supp. 2d 898 (W.D. Tex. 2013)................................................................ passim McNeil v. Wyeth, 462 F.3d 364 (5th Cir. 2006) ........................................................................................14 Michael v. Wyeth, LLC, No. CIV.A. 2:04-0435, 2011 WL 2150112 (S.D. W.Va. May 25, 2011) ................................16 Morgan v. Medtronic, Civ. A. No. 3:15-CV-32, 2016 WL 1162400 (S.D. Tex. Mar. 23, 2016) ............................2, 19 Murthy v. Abbott Labs., 847 F. Supp. 2d 958 (S.D. Tex. 2012) ...........................................................7, 8, 12, 19 Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) ....................................................................................................5 Omni USA, Inc. v. Parker-Hannifin Corp., 964 F. Supp. 2d 805 (S.D. Tex. 2013) .........................................................................20 Phares v. Actavis-Elizabeth LLC, 892 F. Supp. 2d 835 (S.D. Tex. 2012) ...............................................................5, 12, 21 Plotkin v. IP Axess, Inc., 407 F.3d 690 (5th Cir. 2005) ........................................................................................21 Rodriguez v. Gilead Sci., Inc., CIV. A. No. 2:14–CV–324, 2015 WL 236621 (S.D. Tex. Jan. 16, 2015) ...............................17 Rojas v. Teva Pharms. USA, 920 F. Supp. 2d 772 (S.D. Tex. 2013) ...........................................................................9 Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607 (Tex. App.-Waco 1993, writ denied) .......................................................14 St. Gregory Cathedral Sch. v. LG Elecs., Inc., No. 6:12-CV-739, 2015 WL 11121531 (E.D. Tex. Mar. 13, 2015) ........................................22 Sulak v. Am. Eurocopter Corp., 901 F. Supp. 2d 834 (N.D. Tex. 2012) ..........................................................................8 Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 6 of 34 PageID 835 TABLE OF AUTHORITIES Page(s) vi Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308 (2007) ........................................................................................................7 Torkie-Tork v. Wyeth, 739 F. Supp. 2d 895 (E.D. Va. 2010) ..........................................................................16 Torrington Co. v. Stutzman, 46 S.W.3d 829 (Tex. 2000) .............................................................................................7 U.S. Tire–Tech, Inc. v. Boeran, B.V., 110 S.W.3d 194 (Tex. App.-Houston [1st Dist.] 2003, petition denied) .................................19 Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328 (Tex. 1998) ...............................................................................................17 Upjohn Co. v. Freeman, 885 S.W.2d 538 (Tex. App. 1994) ................................................................................25 Willis v. Hospira, Inc., No. 9:13-CV-284, 2014 WL 2795315 (E.D. Tex. June 3, 2014) ....................................7, 9, 12 Willis v. Schwarz-Pharma, Inc., 62 F. Supp. 3d 560 (E.D. Tex. 2014) ...........................................................................13 Wyeth v. Levine, 555 U.S. 555 (2009) ........................................................................................................5 Yates v. Ortho-McNeil-Janssen Pharms., Inc., 808 F.3d 281 (6th Cir. 2015) ....................................................................................5, 18 STATUTES 18 U.S.C. § 201 ...................................................................................................................11 21 U.S.C. § 301 et seq........................................................................................................10 42 U.S.C. § 262 ...................................................................................................................10 21 U.S.C.A. § 355(d)(1-5) ....................................................................................................3, 24 21 U.S.C.A. § 355(d)(7)..............................................................................................................3 Tex. Bus. & Com. Code § 2.607(c)(1) ................................................................................19 Tex. Civ. Prac. & Rem. Code § 82.001(2) ........................................................................ passim Tex. Civ. Prac. & Rem. Code § 82.005(b)(2) ...........................................................................18 Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 7 of 34 PageID 836 TABLE OF AUTHORITIES Page(s) vii Tex. Civ. Prac. & Rem. Code § 82.007 .......................................................................14, 19 Tex. Civ. Prac. & Rem. Code § 82.007(a) ................................................................. passim Tex. Civ. Prac. & Rem. Code § 82.007(a)(1) ..............................................................10, 12 Tex. Civ. Prac. & Rem. Code § 82.007(b)(1) ...............................................................10, 11, 12 Tex. Civ. Prac. & Rem. Code § 82.007(b)(2)-(5) ...... ...........................................................11 OTHER AUTHORITIES 21 C.F.R. § 314.125(b)(6) .....................................................................................................3 Fed. R. Civ. P. 9(b) .............................. ....................................................................... passim Fed. R. Civ. P. 12(b)(6)...............................................................................................1, 6, 25 Restatement (Second) of Conflict of Laws § 145(2) (1971)............................................................7 Restatement (Second) of Torts § 402A, cmt. k. ...... .............................................................5, 15 Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 8 of 34 PageID 837 1 Defendants Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”) (collectively, “Defendants”) submit this Memorandum in Support of their Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(6). For the reasons discussed, Defendants request that Plaintiff’s First Amended Complaint (“FAC”) be dismissed in its entirety. PRELIMINARY STATEMENT Plaintiff Beverly Kaye Graham Orr (“Plaintiff”) brings this product liability action both individually and as Executrix of the estate of her d ceased husband, Robin Orr (“Decedent”).1 Plaintiff alleges that Decedent was prescribed Eliquis on August 2, 2013, “because of his diagnosis of atrial fibrillation.” FAC ¶ 44. On August 13, 2013, Decedent was diagnosed with “severe multi-vessel coronary artery disease,” was scheduled for bypass surgery, and stopped taking Eliquis. Id. Decedent had surgery three days later, on August 16, 2013. Id. According to the FAC, during the surgery, Decedent “sustained a life-threatening, irreversible bleed from the use of Eliquis, as well as severe pain and suffering, all of which culminated in his death on September 1, 2013.” Id. ¶ 10. Defendants are pharmaceutical companies which jointly developed and now manufacture and distribute Eliquis. 1 Plaintiff originally filed this action in Connecti ut state court on July 31, 2015. Defendants removed this suit to federal court on August 13, 2015, pursuant to 28 U.S.C. §§ 1332, 1441, and 1446 (ECF No. 1). On Defendants’ motion, the District of Connecticut transferred the case to this Court on February 24, 2016 pursuant to 28 U.S.C. § 1404(a) (ECF No. 42). Defendants moved to dismiss (ECF No. 59). On May 17, 2016, Plaintiff filed a response in opposition (ECF Nos. 62, 63, and 64) and a motion for leave to file an amended complaint (ECF No. 65). After this Court denied Plaintiff’s motion for leave (ECF No. 66), the parties stipulated that Defendants would not oppose Plaintiff’s filing an amended complaint and that Defendants’ response would be due the later of 30 days following the Court’s approval of the stipulation or the filing of the amended complaint (ECF No. 67). Plaintiff filed a second motion for leave to file an amended complaint on August 4, 2016 (ECF No. 69), which the Court granted the following day (ECF No. 70). Plaintiff f led her FAC on August 5, 2016 (ECF No. 71). Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 9 of 34 PageID 838 2 Eliquis (apixaban) is a novel anticoagulant medication hat thins the blood, prevents the formation of blood clots, and significantly decreass the risk of stroke in patients with atrial fibrillation and certain other conditions. Atrial fibrillation is a common arrhythmia (abnormal heart beat) that causes blood clots to form in the heart and which is known to be associated with a very high risk of stroke. Because strokes are frequently debilitating or even fatal, stroke prevention is a primary goal of atrial fibrillation treatment. Prior to the advent of Eliquis (and other medications in its class), physicians had limited options to decrease the risk of stroke in patients with atrial fibrillation. The mainstay of therapy at the time was warfarin. While Plaintiff describes warfarin as “a long-established safe treatment for preventing stroke and systemic embolism,” FAC ¶ 27, warfarin has a number of significant drawbacks, including a significant risk of bleeding, particularly cerebral hemorrhage (bleeding in the brain), the need for frequent blood tests to monitor medication levels, and a multitude of food and drug interactions that complicate its use and affect patient compliance. Eliquis has been shown to be significantly more effective and less likely to cause bleeding than warfarin. See App. at 15-17, 27-31 (Dec. 2012 Eliquis Label at 6-8, 18-22).2 2 The Eliquis label and all other FDA documents refe nced herein are available on the FDA website at https://www.accessdata.fda.gov/scripts/cder drugsatfda/index.cfm?fuseaction=Search. Label_ApprovalHistory#apphist. Defendants request tha this Court take judicial notice of these documents. See Bass v. Stryker Corp., 669 F.3d 501, 507 (5th Cir. 2012) (stating that “documents describing the FDA’s approval process are subject to judicial notice”); Funk v. Stryker Corp., 631 F.3d 777, 783 (5th Cir. 2011) (taking judicial notice of publicly-available documents produced by FDA, “which were matters of public record directly relevant to the issue at hand”); Morgan v. Medtronic, Civ. A. No. 3:15-CV-32, 2016 WL 1162400, at *4 n.4 (S.D. Tex. Mar. 23, 2016) (taking judicial notice of information on FDA websites because FDA documents “are public government records that are not subject to reasonable dispute”); Cooper v. Pfizer, Inc., CIV. A. No. H-14-3705, 2015 WL 2341888, at *2 (S.D. Tex. May 13, 2015) (taking judicial notice of the contents of FDA-approved label for Lipitor). Further, Plaintiff’s FAC references the Eliquis label and discusses FDA’s medical review of Eliquis. See FAC ¶¶ 29, 33, 41. It is appropriate for the Court to take judicial notice of documents referenced in Plaintiff’s FAC. See Lormand v. US Unwired, Inc., 565 F.3d 228, 251 (5th Cir. 2009). Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 10 of 34 PageID 839 3 For more than a year prior to approval, FDA carefully evaluated the safety and efficacy of Eliquis. As part of its review process, FDA considered the very issues raised by Plaintiff in her FAC, including the bleeding risk with Eliquis, the lack of a reversal agent, and the concerns regarding the alleged conduct of one of the Eliquis clinical trials (“ARISTOTLE”).3 In December 2012, upon completing its review, FDA concluded that, as designed, Eliquis is safe and effective for its intended uses and that the lab ling accurately reflects the scientific evidence regarding its risks and benefits.4 See App. at 3 (Dec. 2012 Approval Letter). The medical community has recognized for decades that all anticoagulant medications increase bleeding risk. Eliquis is no exception, ad the product label always has warned prominently of the bleeding risk associated with use of the medication. Indeed, the word “bleeding” appears no less than 65 times in the original, FDA-approved Eliquis label and Medication Guide.5 The Warnings & Precautions section of the Eliquis label warns physicians explicitly that the medication “can cause serious, potentially fatal bleeding,” that there “is no established way to reverse the anticoagulant effect of apixaban,” and that “[a] specific antidote for ELIQUIS is not available.” App. at 10, 14 (Dec. 2012 Eliquis Label at 1, 5). The Overdosage section of the same label also has warned that “[t]here is no antidote to ELIQUIS” and that “[o]verdose of ELIQUIS increases the risk of bleeding.” Id. at 21 (Dec. 2012 Eliquis 3 See App. at 557-60 for a full summary of Plaintiff’s allegations and FDA’s pre-approval actions related to those issues. 4 FDA may only approve a drug if it finds that the drug “is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof” and “will have the effect it purports or is represented to have.” 21 U.S.C.A. § 355(d)(1-5). FDA must also determine that the proposed label is not “false or misleading in any particular.” 21 U.S.C.A. § 355(d)(7); 21 C.F.R. § 314.125(b)(6); see also In re Celexa & Lexapro Mktg. & Sales Prac. Litig., 779 F.3d 34, 36 (1st Cir. 2015). 5 The Medication Guide is a patient handout that comes with the medication. The guide includes FDA-approved information that can help patients understand how to safely use the medication. Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 11 of 34 PageID 840 4 Label at 12). Likewise, the Medication Guide has advised patients that “ELIQUIS can cause bleeding which can be serious and rarely may lead to death. This is because ELIQUIS is a blood thinner medicine that reduces blood clotting.” Id. at 35 (Dec. 2012 Eliquis Label at 26). And yet, it is this inherent property of Eliquis and all other anticoagulants—this prominently warned-of bleeding risk—that is the focus of Plaintiff’s allegations in this case. This inherent bleeding risk, coupled with prominent a d unambiguous warnings that existed since the time of drug approval, distinguish this ltigation from virtually every other pharmaceutical product liability litigation to date. In this context, Plaintiff’s allegations demand close scrutiny before the parties and the Court embark on protracted and expensive discovery and a pre-trial process that are unnecessary to resolve this action as a matter of law. Plaintiff brings claims under Texas law for strict liability, both under design defect and failure-to-warn theories (Count I), negligence (Count II), gross negligence (Count III), fraud/fraudulent concealment (Count IV), and breach of warranties (Count V). Plaintiff seeks recovery for loss of consortium, emotional distress, lo s of enjoyment, and wrongful death. Each of these causes of action fails as a matter of law. First, while Plaintiff purports to allege a variety of alternative liability theories, the gravamen of all of them is primarily that Defendants failed to warn about the risks associated with Eliquis use (specifically, the risk of bleeding and the fact that Eliquis lacks a reversal agent). These warnings-based claims are preempted under Tex. Civ. Prac. & Rem. Code § 82.007(a) (the “Texas preemption statute”) and the Food, Drug, and Cosmetic Act (“the FDCA”), because there is a rebuttable presumption under the Texas preemption statute that manufacturers ar not liable for failure-to-warn claims where the FDA approved the relevant warnings or inst uctions. The only exception to the statute that could possibly apply here – “fraud-on-the-FDA” – is preempted under both Supreme Court Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 12 of 34 PageID 841 5 and Fifth Circuit precedent, because Plaintiff does not and cannot allege that FDA has made a finding of fraud with regard to Eliquis.6 See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001); Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012). Second, any purported strict liability design defect claims based on the composition or formulation of Eliquis are barred by comment k to the Restatement (Second) of Torts § 402A, which has been adopted by Texas courts and restricts medication design defect claims to failure- to-warn. See, e.g., McKay v. Novartis Pharms., 934 F. Supp. 2d 898, 910 (W.D. Tex. 2013). Plaintiff’s design defect claims also fail because Plaintiff has not adequately alleged that Defendants could have produced a “safer alternative design,” as required under Texas law. See Gerber v. Hoffmann-LaRoche Inc., 392 F. Supp. 2d 907, 922 (S.D. Tex. 2005). Third, Plaintiff’s warranty claims are “little more than a re-packaged failure to warn or design defect claim,” and consequently fail for the reasons discussed above. Conklin v. Novartis Pharms. Corp., Civ. A. No. 9:11CV-178, 2012 WL 4127301, at *4 (E.D. Tex. Sept. 18, 2012). Such claims also fail for lack of notice (express and implied warranties), see McKay v. Novartis Pharm., 751 F.3d 694, 705 (5th Cir. 2014), and for insufficiency of pleading (implied warranty). Fourth, Plaintiff’s “fraud/fraudulent concealment” claim is not pled with the requisite particularity under Fed. R. Civ. P. 9(b), see Phares v. Actavis-Elizabeth LLC, 892 F. Supp. 2d 835, 843 (S.D. Tex. 2012), and, to the extent it relates to an alleged failure to warn, is preempted by Texas and federal law. See Tex. Civ. Prac. & Rem. Code § 82.001(2); Lofton, 672 F.3d at 379. 6 Further, Plaintiff’s failure-to-warn claims are preempted under Wyeth v. Levine, 555 U.S. 555 (2009) and In re Celexa & Lexapro, 779 F.3d at 41, and her design defect claims are preempted under Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) and Yates v. Ortho-McNeil- Janssen Pharms., Inc., 808 F.3d 281 (6th Cir. 2015). Should Plaintiff’s FAC survive this motion to dismiss, Defendants intend to assert these preemption defenses at an appropriate time. Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 13 of 34 PageID 842 6 Finally, Plaintiff’s loss of consortium, wrongful death, and survival action claims are derivative claims and as such must be dismissed becaus all of Plaintiff’s other claims fail. See, e.g., Koenig v. Purdue Pharma Co., 435 F. Supp. 2d 551, 557-58 (N.D. Tex. 2006). Accordingly, Plaintiff’s FAC should be dismissed in its entirety. LEGAL STANDARD FOR A MOTION TO DISMISS In evaluating a motion to dismiss, federal courts follow the pleading requirements established by the U.S. Supreme Court in Ashcroft v. Iqbal, 556 U.S. 662 (2009), and Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007). See Machete Prods., L.L.C. v. Page, 809 F.3d 281, 287 (5th Cir. 2015). “To survive a [Rule 12(b)(6)] motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 570). Additionally, “[f]actual allegations must be enough to raise a right to relief above the speculative level[.]” Twombly, 550 U.S. at 555. This “plausibility standard” requires “more than an unadorned, the-defendant-unlawfully- harmed-me accusation.” Iqbal, 556 U.S. at 678. “[A] plaintiff’s obligation to provide the grounds of his entitle[ment] to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do[.]” Twombly, 550 U.S. at 555 (internal quotation marks and citations omitted). Although a pl intiff’s allegations generally must be accepted as true, courts “are not bound to accept as true a legal conclusion couched as a factual allegation.” Machete Prods., 809 F.3d at 287 (quoting Twombly, 550 U.S. at 555) (internal quotations marks omitted). When evaluating a motion dismiss, “courts must consider the complaint in its entirety, as well as other sources ourts ordinarily examine when ruling on Rule 12(b)(6) motions to dismiss, in particular, documents incorporated into the complaint by reference, and matters of which a court may take judicial notice.” Lormand v. US Unwired, Inc., Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 14 of 34 PageID 843 7 565 F.3d 228, 251 (5th Cir. 2009) (citing Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322 (2007)). Whether a products liability claim is precluded under the Texas preemption statute may be decided on a motion to dismiss. See, e.g., Willis v. Hospira, Inc., No. 9:13-CV- 284, 2014 WL 2795315, at *4-5 (E.D. Tex. June 3, 2014). ARGUMENT AND AUTHORITIES I. Texas Substantive Law Applies to this Case. Texas law governs the claims at issue here. In a diversity case, the forum state provides the law that governs the choice-of-law analysis. Cardoni v. Prosperity Bank, 805 F.3d 573, 580 (5th Cir. 2015). Under Texas choice-of-law principles, the substantive law of the state with the “most significant relationship” will apply. Torrington Co. v. Stutzman, 46 S.W.3d 829, 848 (Tex. 2000). In a tort case, this analysis is governed by four factors: (1) the place where the injury occurred, (2) the place where the conduct causing the injury occurred, (3) the domicile, residence, nationality, place of incorporation and place of business of the parties, and (4) the place where the relationship, if any, between the parties is centered. Id. (citing Restatement (Second) of Conflict of Laws § 145(2) (1971)). All four factors favor application of Texas law, and Plaintiff does not dispute that Texas law applies. See Pl.’s Opp. to Mot. to Dismiss (ECF No. 63) at 8 (stating that Plaintiff “agrees with Defendants that this case should be decided under Texas law”). First, Decedent’s alleged injury occurred in Texas.7 Second, “under Texas law, the place of injury-causing conduct . . . is where the product was used.” Grosskopf v. Chrysler Grp. LLC, 7 The place where the injury occurred is an “important factor” in determining the appropriate choice of law. Murthy v. Abbott Labs., 847 F. Supp. 2d 958, 966 (S.D. Tex. 2012) (quoting Huddy v. Fruehauf Corp., 953 F.2d 955, 957 (5th Cir. 1992)). Medical records attached to the original complaint establish, and it is undisputed, that Decedent “died at the Lubbock Heart Hospital, Lubbock County, Texas” and that at the time of his death “had a fixed place of Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 15 of 34 PageID 844 8 No. A-14-CA-801, 2015 WL 6021851, at *4 (W.D. Tex. Oct. 14, 2015) (citing Sulak v. Am. Eurocopter Corp., 901 F. Supp. 2d 834, 843 (N.D. Tex. 2012)). Here, D cedent, a Texas resident, presumably was prescribed and took Eliquis in Texas. Third, although Defendants are incorporated in Delaware and have their principal pl ces of business in New York, Plaintiff’s domicile is in Texas. Finally, the relationship between the parties is centered in Texas, because “where there is no pre-existing contractual relationship between the parties . . . the place where the relationship is centered is duplicative of the place of injury.” Grosskopf v. Chrysler Grp., 2015 WL 6021851, at *5 (citing Denman by Denman v. Snapper Div., 131 F.3d 546, 549-50 (5th Cir. 1998)). Under nearly identical circumstances, federal courts in Texas have applied Texas law in similar product liability actions involving medications. See, e.g., McKay v. Novartis Pharm. Corp., 751 F.3d 694, 702 (5th Cir. 2014) (“McKay II”) (applying Texas law where plaintiff was a Texas citizen residing in Texas, Texas physicians evaluated and treated him, Texas physicians prescribed him the medication in question, and plaintiff took the medication and suffered the alleged injury in Texas); Murthy v. Abbott Labs., 847 F. Supp. 2d 958, 967 (S.D. Tex. 2012) (applying Texas law in suit arising from use of prescription medication Humira where plaintiff received Humira in Texas and was treated in Texas for lymphoma allegedly resulting from use of Humira). The United States District Court for the District of Connecticut, applying a similar standard in deciding whether to transfer this case to this Court, held: [T]he facts alleged in the complaint indicate that a significant portion of the operative facts occurred in Texas. Here, decedent is alleged to have lived and died in Texas. Thus, facts concerning decedent’s medical treatment, his prescription for Eliquis, and the circumstances of his death all occurred in Texas. residence in Howard County, Texas.” ECF No. 1-1 at 5. Further, Plaintiff alleges that she was appointed executrix of Decedent’s estate in Texas, FAC ¶ 7, and that “Decedent’s estate is being administered under the laws of Texas.” FAC ¶ 8. Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 16 of 34 PageID 845 9 ECF No. 42 at 3. For all of these reasons, Texas law should apply to Plaintiff’s claims. II. Plaintiff’s Claims Are Foreclosed by Texas and Federal Law. A. The Texas Preemption Statute Applies to All Products Liability Claims Based on an Alleged Failure to Warn. Under Texas law, if a claim is based upon a medication’s “labeling, its omissions, or inaccuracies, it falls under” the ambit of the Texas preemption statute.8 Del Valle v. Qualitest Pharms. Inc., CIV. No. B-11-113, 2012 WL 2899406, at *2 (S.D. Tex. June 22, 2012) (citing Tex. Civ. Prac. & Rem. Code § 82.007(a)), aff’d sub nom. Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014). In other words, “whether one pleads [a failure-to-warn claim] as a negligence cause of action, a strict liability claim, or a breach of implied warranty of merchantability, one is still limited by [the Texas preemption statute] in the manner in which he/she may recover.” Del Valle v Qualitest, 2012 WL 2899406, at *2; see also Willis v. Hospira, Inc., No. 9:13-CV-284, 2014 WL 2795315, at *4 (E.D. Tex. June 3, 2014) (same). Accordingly, to the extent that Plaintiff’s strict liability, negligence, gross negligence, fraudulent concealment, and breach of warranty claims are premised on allegations regarding the adequacy of the warnings in the Eliquis label, those claims are all subject to the limitations of the Texas preemption statute.9 See In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 802 (E.D. Tex. 2002). 8 The Texas preemption statute defines a “product liability action” as “any action against a manufacturer or seller for recovery of damages arising out of personal injury, death, or property damage allegedly caused by a defective product whether the action is based in strict tort liability, strict products liability, negligence, misrepresentation, breach of express or implied warranty, or any other theory or combination of theories.” Tex. Civ. Prac. & Rem. Code § 82.001(2). 9 To the extent that Plaintiff also alleges that Defendants failed to adequately test Eliquis, such cause of action does not exist under Texas law. See Rojas v. Teva Pharms. USA, 920 F. Supp. 2d 772, 778 (S.D. Tex. 2013). Likewise, to the extent Plaintiff alleges that Defendants failed to warn Decedent and/or the public, see, e.g., FAC ¶ 4, such claims must be dismissed under the learned intermediary doctrine, which allows a “manufacturer to rely on the health care provider to pass on its warnings.” Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 155 (Tex. 2012). Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 17 of 34 PageID 846 10 B. Under the Texas Preemption Statute, There Is a Rebuttable Presumption that Defendants Are Not Liable for Any Alleged Failure to Warn. The Texas preemption statute establishes a rebuttable presumption that manufacturers are not liable for failure-to-warn claims where the FDA approved the relevant warnings or instructions. The relevant portion of that statute provides: In a products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product, there is a rebuttable presumption that the defendant or defendants, including a health care provider, manufacturer, distributor, and prescriber, are not liable with respect to the allegations involving failure to provide adequate warnings or information if: (1) the warnings or information that accompanied the product in its distribution were those approved by the United States Food and Drug Administration for a product approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), as amended, or Section 351, Public Health Service Act (42 U.S.C. Section 262), as amended . . . Tex. Civ. Prac. & Rem. Code § 82.007(a). It is undisputed that the Eliquis label was “approved by [FDA] . . . under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.),” Tex. Civ. Prac. & Rem. Code § 82.007(a)(1); App. at 3 (Dec. 2012 Approval Letter at 1), and Plaintiff does not allege that the label deviated in any way from that approved by FDA. Accordingly, a rebuttable presumption exists in favor of dismissing all of Plaintiff’s claims predicated on a failure-to-warn theory. C. Plaintiff’s Failure to Warn Claims Are Not Saved by the Texas Savings Clause. A rebuttable presumption under the Texas preemption statute can only be overcome by establishing that one of five exceptions identified n the Texas savings clause applies. See Tex. Civ. Prac. & Rem. Code § 82.007(b)(1). The only potentially relevant exception in this case comes into play where a manufacturer has “before or after pre-market approval or licensing of the product, withheld from or misrepresented to the[FDA] required information that was material and relevant to the performance of the product and was causally related to the Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 18 of 34 PageID 847 11 claimant’s injury.”10 Id.; Del Valle v. Qualitest, 2012 WL 2899406, at *2 (“In order to maintain a cause of action [for failure to warn], there must be, in shorthand terms, some form of fraud on the FDA.”). In Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), the Supreme Court held that “fraud-on-the-FDA” claims are preempted by the FDCA, because such claims “exist solely by virtue of the FDCA disclosure requirements.” 531 U.S. at 353. Applying Buckman, the Fifth Circuit has held repeatedly that “fraud-on-the-FDA” failure-to-warn claims falling under the ambit of the Texas savings clause are prempted, unless the FDA has itself formally concluded that the defendant has committed fraud on the agency. For example, in Lofton v. McNeil Consumer & Specialty Pharmaceuticals., 672 F.3d 372 (2012), the Fifth Circuit considered federal preemption in the context of a ph rmaceutical products liability case in which the plaintiff claimed that the manufacturer withheld information from FDA regarding the risk of a particular severe (and potentially fatal) reaction t Motrin. The court held that the plaintiff’s failure-to-warn claims were preempted because there ad been no finding of fraud by FDA itself.11 672 F.3d at 379. As the court explained, absent a formal finding by FDA, application of the Texas savings clause interferes with the FDA’s administration of the FDCA—because to establish a violation of the FDCA, the plaintiff and the court would have to “re-tread” FDA’s administrative ground and thus run afoul of Buckman’s prohibition of claims based purely on “fraud-on-the-FDA.” Id. at 380. The Fifth Circuit later reiterated this con lusion in Lashley v. 10 The presumption may also be rebutted where a medication is sold after FDA ordered it removed from the market, the injury arises from off-label promotion or prescription, or the manufacturer has violated the anti-bribery provision in 18 U.S.C. § 201 in obtaining approval for a medication’s warnings or instructions. Tex. Civ. Prac. & Rem. Code § 82.007(b)(2)-(5). None of those exceptions apply here. 11 Contrary to Plaintiff’s claim, the Fifth Circuit did not “delet[e] one of [the] mechanisms” for overcoming the presumption under the Texas preemption statute (ECF No. 63 at 13), but rather added the additional requirement that FDA itself must conclude that fraud had occurred. Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 19 of 34 PageID 848 12 Pfizer, Inc., holding that there must be a formal finding of fraud by FDA itself for a claim to survive under section 82.007(b)(1).12 750 F.3d at 477-78. Since the ruling in Lofton, federal courts in Texas have nearly unanimously he d that the “fraud-on-the-FDA” exception to the Texas preemption statute is itself preempted by the FDCA, unless the FDA has made a formal finding of fraud, and have dismissed failure-to-warn claims at the motion to dismiss stage. For example, in Willis v. Hospira, Inc., on motion to dismiss, the Eastern District of Texas held that several product liability claims arising from the use of Reglan were preempted because the plaintiff had not “pled nor shown that the FDA itself found fraud by [defendant], foreclosing his fraud exception claim under the Texas Civil Practice and Remedies Code.” 2014 WL 2795315, at *5 (citing Lofton, 672 F.3d at 381). Similarly, in Phares v. Actavis-Elizabeth LLC, 892 F. Supp. 2d at 842-43, on motion to dismiss by manufacturers of a generic medication to treat gastritis, the court held that the plaintiff’s failure-to-warn claims were preempted because the amended complaint “fail[ed] to allege that the FDA has found fraud on the part of [the manufacturer].” Finally, in Cooper v. Pfizer, Inc., Civ. A. No. H-14-3705, 2015 WL 2341888 (S.D. Tex. May 13, 2015), on motion for judgment on the pleadings, the Southern District of Texas held that product liability claims involving Lipitor were preempted because, 12 To the extent that Plaintiff contends (as she did in opposition to Defendants’ first motion to dismiss) that “the preempted portion of the statute is not severable from the rest” and therefore “the entire statute has no effect” (see, e.g., Pl.’s Opp. to Mot. to Dismiss, ECF No. 63 at 10-15), every federal court in Texas that has addressed this argument, including this Court, has rejected it. See Anderson v. Abbott Laboratories, No. 3:11–CV–1825–L, 2012 WL 4512484, at *6 (N.D. Tex. Sep. 30, 2012) (“[S]ections 82.007(a)(1) and 82.007(b)(1) are independent of and severable from one another, and the preemption of 82.007(b)(1) does not affect section 82.007(a)(1)”); McKay I, 934 F. Supp. 2d at 907-8 (“[S]ections 82.007(a)(1) and 82.007(b)(1) are independent of and severable from one another . . . Moreover, the non-liability presumption in section 82.007(a)(1) can be rebutted by other sections of the s atute”); Murthy v. Abbott Labs., 847 F. Supp. 2d at 976 n.8 (“[O]nce § 82.007(b)(1) is stricken, § 82.007(a) remains complete in itself, and capable of being executed in accordance with the apparent legislative intent-specifically, of limiting the liability of health care providers, manufacturers, distributors, and prescribers in pharmaceutical failure to warn cases.”). Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 20 of 34 PageID 849 13 inter alia, the plaintiff “[did] not allege that the FDA has made a finding of fraud in this case.” 2015 WL 2341888, at *2. Although the plaintiff argued against preemption, the court found that argument “has been very clearly foreclosed by the Fifth Circuit’s ruling in Lofton.” Id.13 Here, Plaintiff has not – and cannot – allege that FDA has made a finding of fraud with regard to Eliquis. Under Texas law, the standard fo “fraud-on-the-FDA” claims is strict; such a claim “is not a wide open forum for evidence of a defendant’s malfeasance or nonfeasance.” Jackson v. Wyeth LLC, No. CIV.A. 2:12-CV-196, 2015 WL 363513, at *2 (S.D. Tex. Jan. 27, 2015). Rather, “the Plaintiff must show that the FDA, itself, has pursued Defendants and prevailed on such claims of violations of the federal law governing disclosures and reports on regulated pharmaceuticals.” Id. (citing Lofton, 672 F.3d at 379-80). Plaintiff cannot do so. Thus, under the Supreme Court’s holding in Buckman, and applicable Fifth Circuit law, Plaintiff cannot avail herself of the “fraud-on-the-FDA” exception in the Texas savings clause. Accordingly, her failure-to-warn claims (whether pled under strict liability, negligence, gross negligence, fraudulent concealment, or warranty) should all be dismissed. See McKay v. Novartis Pharms. Corp., 934 F. Supp. 2d 898, 908 (W.D. Tex. 2013) (“McKay I”) (holding that “a plaintiff’s failure to warn claims – although labeled as negligence, strict liability, and breach 13 See also Jackson v. Wyeth LLC, No. 2:12-cv-196, 2015 WL 363513 (S.D. Tex. Jan. 27, 2015) (summary judgment granted to defendant as to claims arising from use of Reglan); Willis v. Schwarz-Pharma, Inc., 62 F. Supp. 3d 560, 568 (E.D. Tex. 2014) (same); Gonzalez v. Bayer Healthcare Pharms., Inc., 930 F. Supp. 2d 808, 819-20 (S.D. Tex. 2013) (claims arising from use of IUD dismissed because no FDA finding of fraud); Anderson v. Abbot Laboratories, No. 3:11-cv-1825-L, 2012 WL 4512484, at *4 (N.D. Tex. Sept. 30, 2012) (claims arising from use of Humira dismissed to the extent that failure-to-warn theory was based on savings clause); Del Valle v. PLIVA, Inc., CIV. No. B-11-113, 2012 WL 4747259, at *8 (S.D. Tex. Sept. 12, 2012) (granting summary judgment for defendant on preemption principles because under Lofton, “a state court may not find that a defendant defraud[ed] the FDA, unless the FDA has first found that it has been defrauded by the defendants” and “fe eral courts—applying Texas law—are mandated to reach the same conclusion.”); Eckhardt v. Qualitest Pharms. Inc., 858 F. Supp. 2d 792, 799 (S.D. Tex. 2012) (claims arising from use of metoclopramide dismissed because no allegations of FDA finding of fraud). Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 21 of 34 PageID 850 14 of warranty – nonetheless are subject to the statutory presumption of non-liability found in Section 82.007”).14 III. Plaintiff’s Design Defect Claims Fail as a Matter of Law. In Counts I, II, and III, Plaintiff alleges design defect claims under theories of strict liability (FAC ¶¶ 52-77), negligence, and gross negligence (FAC ¶¶ 84-95).15 To the extent the claims are based on an alleged deficiency of the warnings included in the Eliquis label, they are barred by the Texas preemption statute, as discussed above. And, to the extent they are based on the composition or formulation of Eliquis, the claims fail because Texas law prohibits non- warnings based strict liability design defect claims, and Plaintiff has not pled a safer alternative design. A. Comment k Bars Plaintiff’s Non-Warnings-Based Strict Liability Design Defect Claims. Under Texas law, manufacturers of prescription medications like Eliquis “cannot be held strictly liable where the drugs are accompanied by an adequate warning.” McKay I, 934 F. Supp. 2d at 910; see also Holland v. Hoffman-LaRoche, Inc., No. 3-06-CV-1298, 2007 WL 4042757, at 14 Moreover, “[i]n prescription drug cases involving the learned intermediary doctrine . . . when ‘a warning specifically mentions the circumstances complained of, the warning is adequate as a matter of law.’” McNeil v. Wyeth, 462 F.3d 364, 368 (5th Cir. 2006) (quoting Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607, 609 (Tex. App.-Waco 1993, writ denied)). As discussed above, the Eliquis label always prominently has warned that the medication can cause “serious, potentially fatal, bleeding” and that no method exists to effectively reverse its anticoagulant effect. See supra at 3. 15 In her prior Opposition, Plaintiff stated that she was “not pursuing any claim, under either a strict liability theory or negligence, based on a lleged defect in the manufacturing of Eliquis.” ECF No. 63 at 15. Plaintiff’s FAC is not clear on this point. See, e.g., FAC ¶ 48 (“Defendants had a products liability duty under Texas law to design, manufacture, and market products, including Eliquis, that were not unreasonably dangerous or defective, but which were safe for their users, including Decedent.”). Regardless, any manufacturing defect claim fails as Plaintiff has not pled that the Eliquis decedent took “deviate[d], in its construction or quality, from the specifications or planned output in a manner that renders it unreasonably dangerous.” Cooper Tire & Rubber Co. v. Mendez, 204 S.W.3d 797, 800 (Tex. 2006). Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 22 of 34 PageID 851 15 *3 (N.D. Tex. Nov. 15, 2007) (same); Gerber v. Hoffmann-LaRoche Inc., 392 F. Supp. 2d 907 at 922 (same). Texas courts have adopted comment k to the Restatemen (Second) of Torts § 402A. See Massey v. Novartis Pharms. Corp., 46 F. Supp. 3d 688, 691 (W.D. Tex. 2014); Centocor, Inc. v. Hamilton, 310 S.W.3d 476, 516 (Tex. App.—Corpus Christi 2010, pet. granted), rev’d in part on other grounds, Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012). Comment k states, in relevant part, that “some products, such as certain drugs, are so beneficial and necessary that the manufacturer of those products should not, in all instances, be held strictly liable for unforeseeable harm.” Restatement (Second) of Torts § 402A, cmt. k. Texas courts uniformly apply comment k to all presciption medications and limit product liability claims involving such medications to adequacy of the warning. For example, in McKay I, the Western District of Texas granted judgment for the defendant, a pharmaceutical manufacturer, as to the plaintiff’s design defect claim arising from the use of two medications to treat bone disorders, because under comment k, “[p]rescription drugs are not susceptible to a design defect claim where . . . the drug is accompanied by proper directions and a warning.” 934 F. Supp. 2d at 910. Similarly, in Holland v. Hoffman-LaRoche, Inc., this Court held that a design defect claim arising from the use of a medication did not present a “triable issue” under comment k where the medication was accompanied by a proper warning. 2007 WL 4042757, at *3. See also Gerber v. Hoffmann-LaRoche Inc., 392 F. Supp. 2d at 922. As the Western District of Texas has explained, “[t]o allow plaintiffs to sue for defective design of prescription drugs would provide a disincentive to companies to develop new drugs and would allow juries to second- guess the FDA’s approval of the drugs for marketing.” Hackett v. G.D. Searle & Co., 246 F. Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 23 of 34 PageID 852 16 Supp. 2d 591, 595 (W.D. Tex. 2002). The same reasoning applies here, and Plaintiff’s non- warnings-based design defect claims fail as a matter of law. B. Plaintiff Fails to Satisfy the Elements of a Strict Liability or Negligent Design Defect Claim. Plaintiff’s non-warnings-based design defect claims – whether pled in negligence or strict liability – also fail because Plaintiff has not sufficiently pleaded that a safer alternative design existed. In considering Plaintiff’s non-warnings-based design defect claim, it is important to remember that the very design characteristic that makes Eliquis an anticoagulant (i.e., its ability to thin the blood) also increases the risk of bleeding. See supra at 3-4. Absent this characteristic, Eliquis would not be an anticoagulant, or fulfill the purpose for which it was designed. Under Texas law, “a plaintiff cannot prove design defect by claiming that defendant should have sold an entirely different product.” Brockert v. Wyeth Pharms., Inc., 287 S.W.3d 760, 770 (Tex. App. 2009). See also Massa v. Genentech Inc., CIV. A. No. H-11-70, 2012 WL 956192, at *7 (S.D. Tex. Mar. 19, 2012) (holding that plaintiff’s design defect claim failed because argument that prescription medication “could have been formulated with a number of alternative underlying compounds is not an argument tha [the medication] should have been safer; it is an argument that [the medication] should have been a different product.”) (emphasis in original); Michael v. Wyeth, LLC, No. CIV.A. 2:04-0435, 2011 WL 2150112, at *11 (S.D. W.Va. May 25, 2011) (“[A]n alternative design is not reasonable if it alters a fundamental and necessary characteristic of the product.”) (citation omitted); Torkie-Tork v. Wyeth, 739 F. Supp. 2d 895, 900 (E.D. Va. 2010) (“[a]n alternative design must not be an altogether essentially different product”). As the Texas Supreme Court stated in Caterpillar, Inc. v. Shears, “A motorcycle could be made safer by adding two additional wheels and a cab, but then it is no longer a motorcycle.” 911 S.W.2d 379, 385 (Tex. 1995). The same is certainly true here. Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 24 of 34 PageID 853 17 “To prove a design defect, a claimant must establish, among other things, that the defendant could have provided a safer alternative design.”16 Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 335 (Tex. 1998); see also Gerber v. Hoffmann-LaRoche Inc., 392 F. Supp. 2d at 922. “[I]f there are no safer alternatives, a product is not unreasonably dangerous as a matter of law.” Caterpillar, Inc. v. Shears, 911 S.W.2d at 384. “Even at the motion to dismis stage, ‘a safer alternative design is a necessary component to a design defect claim.’” Barragan v. Gen. Motors LLC, No. SA-15-CV-854, 2016 WL 3519675, at *3 (W.D. Tex. June 22, 2016) (quoting Rodriguez v. Gilead Sci., Inc., CIV. A. No. 2:14–CV–324, 2015 WL 236621, at *3 (S.D. Tex. Jan. 16, 2015)). Thus, “federal procedural law requires that the pleading allege sufficient facts to support the plausibility of tha element” and conclusory allegations will not suffice. Rodriguez v. Gilead Sci., 2015 WL 236621, at *3 (dismissing design defect claims). With regard to a safer alternative design, Plaintiff s ates only: “A safer alternative design of Eliquis would have included, inter alia, a proper therapeutic range of dosing, a recommended regime of monitoring/testing, availability of an effective reversal agent, and proper instructions on the half-life of Eliquis and how long it must bediscontinued before surgery.” FAC ¶ 74. These conclusory allegations are not sufficient to support Plaintiff’s design defect claim. As a threshold matter, any safer alternative designs requiring Defendants to change the warnings and instruction in the FDA-approved Eliquis label (e.g., recommendations about dosing, monitoring/testing, or instructions about half-life and discontinuation before surgery) are 16 While “negligent design [] claims are conceptually distinguishable from . . . strict liability claims[,]” Texas courts have made clear that both claims “are predicated on the existence of a safer alternative design[.]” Am. Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420, 437 (Tex. 1997); see also McAndrews v. C.R. Bard, Inc., CIV. A. No. H-14-2504, 2015 WL 2089432, at *3 (S.D. Tex. May 5, 2015) (“Under Texas law, a plaintiff tha fails to allege the elements of a strict liability claim cannot pursue a claim for negligenc since a defendant cannot be negligent for manufacturing a product that was not unreasonably dangerous.”) (citing Garrett v. Hamilton Standard Controls, Inc., 850 F.3d 253 (5th Cir. 1988)). Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 25 of 34 PageID 854 18 preempted under Texas law. See supra at 9. As to the other alternatives, Plaintiff does not plead facts sufficient to establish what those alternatives would look like, or that any were “economically and technologically feasible at the time the product left the control of the manufacturer or seller by the application of existing or reasonably achievable scientific knowledge.” Tex. Civ. Prac. & Rem. Code § 82.005(b)(2). For example, Plaintiff does not allege what a “proper therapeutic range of dosing” would be, or that such dose range “would be safer [and] be as effective” as that approved by FDA. See Massa v. Genentech Inc., CIV. A. No. H-11-70, 2012 WL 956192, at *6 (S.D. Tex. Mar. 19, 2012). Likewise, Plaintiff does not allege that an “effective reversal agent” was feasible at the relevant time, let alone would have been approved by FDA.17 Accordingly, Plaintiff’s design defect claim, whet r based on a strict liability or negligence theory, should be dismissed. IV. Plaintiff’s Warranty Claims Fail as a Matter of Law . Plaintiff further alleges causes of action for breach of express and implied warranties. FAC ¶¶ 116-17. As an initial matter, Plaintiff’s warranty claims, alleging only that Eliquis was “safe and efficacious for its intended uses[,]” “was not unreasonably dangerous and instead [was] merchantable and fit for its intended use[,]” and “had been fully and adequately tested for long- term use” (FAC ¶ 116), are “little more than a re-packaged failure to warn or design defect claim.” Conklin v. Novartis Pharmas., 2012 WL 4127301, at *4. Because Plaintiff’s warnings- based claims are barred by the Texas preemption statute nd Plaintiff’s composition-based design defect claims are precluded by comment k, Plaintiff’s warranty claims should be 17 To date, no such monitoring method or reversal agent has been approved. And, as the Sixth Circuit explained in Yates, arguments as to the viability of safer alternative designs in the pharmaceutical context are “attenuated” because they require courts to “speculate” as to whether FDA would have approved the alternate design in the first place and, if so, whether such alternate design would not have caused the plaintiff’s alleged injury – assumptions which are “several steps too far.” Yates, 808 F.3d at 299. Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 26 of 34 PageID 855 19 dismissed. See Cooper, 2015 WL 2341888, at *3 (dismissing breach of warranty claims under Tex. Civ. Prac. & Rem. Code §§ 82.001(2) and 82.007(a)); Murthy, 847 F. Supp. 2d at 967 (breach of warranty claim barred by § 82.007); Massa v Genentech, 2012 WL 956192, at *9-10 (“Because the Court already has found that [plaintiff] failed to demonstrate that [the prescription drug] was defectively designed, his claim for breach of implied warranty also must fail.”). Plaintiff’s warnings claims also fail for additional reasons. “To recover on a breach of warranty claim in Texas, ‘the buyer must within a re sonable time after he discovers or should have discovered any breach notify the seller of breach or be barred from any remedy.’” McKay II , 751 F.3d at 705 (quoting Tex. Bus. & Com. Code § 2.607(c)(1)). “The burden of ‘alleging and proving proper notice’ is on the buyer, and ‘[f]ailure to notify the seller of the breach, thereby allowing the seller an opportunity to cure, bars recovery on the basis of breach of warranty.’” Id. (quoting Lochinvar Corp. v. Meyers, 930 S.W.2d 182, 189 (Tex. App.-Dallas 1996)). “The manufacturer must be made aware of a problem with a particular product purchased by a particular buyer.” Massey v. Novartis Pharms., 46 F. Supp. 3d at 692 (quoting U.S. Tire–Tech, Inc. v. Boeran, B.V., 110 S.W.3d 194, 201–02 (Tex. App.-Houston [1st Dist.] 2003, petition denied)); see also Morgan v. Medtronic, Inc., Civ. A. No. 3:15-CV-32, 2016 WL 1162400, at *9 (S.D. Tex. Mar. 23, 2016). Plaintiff does not, and cannot, allege that she has taken any of these steps.18 18 Additionally, Plaintiff’s express warranty claim cannot survive absent privity between the parties. Plaintiff does not allege that Decedent purchased Eliquis directly from Defendants, or that he was otherwise in contractual privity with Defendants. See Barragan v. Gen. Motors LLC, CV No. 4:14-CV-93, 2015 WL 5734842, at *9 (W.D. Tex. Sept. 30, 2015) (holding that under Texas law, “[t]o recover for breach of express warranty, the plaintiff must be in privity with the manufacturer or seller of the product” and because “[p]laintiffs do not allege that they purchased the vehicle involved in the accident from [the manuf cturer]” they “have not alleged the privity relationship necessary to state a claim against a seller for breach of express warranty”). But see Enpro Sys., Ltd. v. Namasco Corp., 382 F. Supp. 2d 874, 888 (S.D. Tex. 2005) (“Texas law Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 27 of 34 PageID 856 20 Plaintiff also does not plead the requisite elements of an implied warranty claim. Here, Plaintiff’s FAC simply states that Defendants breached an implied warranty that Eliquis was safe and effective for its intended uses. FAC ¶¶ 116-17. On its face, this appears to be a cause of action for breach of implied warranty of merchantability, which requires that Plaintiff “demonstrate a defect in the condition of the goods that renders them unfit for the ordinary purposes for which they are used.” Omni USA, Inc. v. Parker-Hannifin Corp., 964 F. Supp. 2d 805, 817 (S.D. Tex. 2013) (internal citations omitted). Beyond conclusory allegations, Plaintiff has pled no facts to support her claim. For this additional reason, her implied warranty cause of action should be dismissed. V. Plaintiff’s “Fraud/Fraudulent Concealment” Claim Fa ils as a Matter of Law. Plaintiff’s cause of action for “fraud/fraudulent concealment”19 fails because the claims are barred by the Texas preemption statute, are not pled with the particularity required by Rule 9(b), and are factually accurate and/or irrelevant to Plaintiff’s litigation claims.20 A. Plaintiff’s Fraud Claims Are Barred by the Texas Preemption Statute. Fraud claims, like all other product liability claims, are governed by the Texas preemption statute.21 As discussed above, the statute bars warnings claims gainst manufacturers likely permits an express warranty claim against a remote manufacturer or supplier, although the question is not finally settled.”). 19 Under Texas law, “fraudulent concealment is an affirmative defense to limitations, and not an independent cause of action[.]” Gaona v. Garland Surgicare Partners, Ltd., No. 05-15- 00645-CV, 2016 WL 4189343, at *3 (Tex. App. Aug. 8, 2016) (citing KPMG Peat Marwick v. Harrison Cnty. Hous. Fin. Corp., 988 S.W.2d 746, 749 (Tex. 1999)). 20 Defendants deny all of Plaintiff’s fraud allegations. 21 The statutory language makes clear that its preemptive effect applies to “any action against a manufacturer or seller for recovery of damages arising out of personal injury, death, or property damage allegedly caused by a defective product whether the action is based in strict tort liability, strict products liability, negligence, misrepresentation, breach of express or implied warranty, or any other theory or combination of theori s.” Tex. Civ. Prac. & Rem. Code Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 28 of 34 PageID 857 21 of pharmaceutical products, absent a formal finding of fraud by FDA. Because Plaintiff’s fraud claims are premised on allegations regarding the adequacy of the warnings in the Eliquis label and FDA never has determined that Defendants have committed any form of fraud, Plaintiff’s cause of action for “fraud/fraudulent concealment” should be dismissed. See, e.g., Cooper v. Pfizer, 2015 WL 2341888, at *3 (dismissing fraud claims as f ilure to warn claims under § 82.001(2)). B. Plaintiff’s Fraud Claims Are Not Pled with the Particularity Required Under Rule 9(b). Pursuant to Rule 9(b), fraud claims must be pled with particularity, including “specificity as to the statements (or omissions) considered to be fraudulent, the speaker, when and why the statements were made, and an explanation of why thew re fraudulent.” Hoffman v. AmericaHomeKey, Inc., 23 F. Supp. 3d 734, 741-42 (N.D. Tex. 2014) (quoting Plotkin v. IP Axess, Inc., 407 F.3d 690, 696 (5th Cir. 2005)). The vast majority of fraud-based claims in Plaintiff’s FAC are vague and conclusory, lacking any specificity as to the nature, format, and content of the alleged representation or omission: • “Defendants, their agents, servants, and/or employees were negligent in the design, manufacture, sale, labeling, warnings, marketing, promotion, quality assurance, quality control, and sale, distribution of Eliquis in that, among other things, they . . . Conceal[ed] information from Decedent showing that Eliquis was unsafe, dangerous, and/or non-conforming with FDA regulations[.]” FAC ¶ 87(t). • “Prior to Decedent’s use of Eliquis and during the p riod in which Decedent actually used Eliquis, Defendants fraudulently suppressed material information regarding the safety and efficacy of Eliquis.” FAC ¶ 97. § 82.001(2) (emphasis added); see also Phares v. Actavis-Elizabeth LLC, 892 F. Supp. 2d 835, 844 (S.D. Tex. 2012) (despite plaintiff’s styling of her claim as a fraud claim, “[u]nder the plain language of § 82.001(2), this remains a products liability action predicated upon defective marketing or warnings”). Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 29 of 34 PageID 858 22 • “These representations were made by said Defendants with the intent of defrauding and deceiving Decedent, the public in geeral, and the medical and healthcare community in particular (including Mr. Orr’s prescribing physicians) . . .” FAC ¶ 99. • “Defendants brought Eliquis to the market, and acted fraudulently, wantonly and maliciously to the detriment of Plaintiff.” FAC ¶ 104. • “Upon information and belief, Plaintiff avers that Defendants actively and fraudulently concealed information in Defendants’ exclusive possession regarding the hazards associated with Eliquis, for the purpose f preventing consumers, such as Decedent, from discovering these hazards.” FAC ¶ 115. See also FAC ¶¶ 4, 25, 75, 87(f), 105, 110, 115. Such threadbare allegations cannot satisfy the heightened pleading requirements under Rule 9(b). C. Statements in Documents Identified by Plaintiff Are Neither False Nor Relevant to Her Litigation Claims. In paragraph 98 of the FAC, Plaintiff identifies several documents that she contends contain fraudulent misrepresentations and omissions. These include three pages from the Eliquis.com website, a Dosing Guideline from March 2014, a package insert from December 2012, and a package insert from March 2014. As discussed below, however, the statements Plaintiff points to in these documents are factually ccurate and/or lack the necessary causal nexus to Plaintiff’s litigation claims. March 2014 Dosing Guidelines and package insert. The March 2014 Dosing Guidelines and package insert both post-date Decedent’s Eliquis use in 2013, and thus could not have been relied on by his physician when prescribing Eliquis. FAC ¶¶ 98(d) and 98(f). As such, they are irrelevant to Plaintiff’s claim. See St. Gregory Cathedral Sch. v. LG Elecs., Inc. No. 6:12-CV-739, 2015 WL 11121531, at *5 (E.D. Tex. Mar. 13, 2015) (holding that fraud Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 30 of 34 PageID 859 23 allegations failed Rule 9(b)’s particularity standard because, inter alia, documents relied upon by plaintiffs post-dated materials that plaintiffs claimed were fraudulent). December 2012 package insert. Plaintiff first claims that the “recommended dosage [in the December 2012 package insert] is false, as the pati nt characteristics were inappropriate and should have been limited to one characteristic, instead of two of the listed characteristics.” FAC ¶ 98(e)(i). Even if it were true, this allegation lacks a causal nexus to Decedent’s injury. See Geisler v. Texas Commerce Bank, No. 05-91-01148-CV, 1993 WL 530315, at *14 (Tex. App. Dec. 21, 1993), writ denied (July 28, 1994) (holding that plaintiffs were required “to establish the causal nexus between the fraud committed . . . and any damages suffered”). Plaintiff’s statement suggests that the FDA-approved label—which re ommends decreasing the Eliquis dose from 5 mg to 2.5 mg in patients who have t least two of the following characteristics: age ≥ 80, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dl—should have recommended that the dose be decreased to 2.5 mg in patients who have one or more of those characteristics. But Plaintiff’s FAC does not include any information asto the actual Eliquis dose Decedent took (whether it was 5 mg or 2.5 mg), or as to whether Decedent had any of the relevant characteristics (age ≥ 80, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dl) at the time he was prescribed Eliquis. If Decedent was prescribed Eliquis at the 2.5 mg dose, or had none of the three characteristics, the alleged misrepresentatio would not have affected the dose he was given by his physician. Thus, even assuming the dosing recommendations in the label were false as Plaintiff asserts, Plaintiff has neither alleged nor established the presence of the requisite causal nexus between the alleged misrepresentation and Decedent’s injury. Plaintiff next alleges that “[w]hile there is a statement made [in the December 2012 package insert] that there is no reversal agent, Defendants withheld information and data that Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 31 of 34 PageID 860 24 without the reversal agent, death could result.” FAC ¶ 98(e)(ii). That claim is meritless on its face, as the FDA-approved Eliquis label has always prominently warned that Eliquis “can cause serious, potentially fatal, bleeding.” App. at 14 (Dec. 2012 Eliquis Label at 5); see also supra t 3. Eliquis.com Website. Plaintiff claims that Defendants made three fraudulent representations on the Eliquis.com website: (1) that Eliquis was proven effective for nonvalvular atrial fibrillation in Phase III studies, ee FAC ¶ 98(a), (2) that Eliquis is the only anticoagulant that demonstrated superiority in both stroke and systemic embolism and major bleeding versus warfarin, see FAC ¶ 98(b), and (3) that Eliquis had less major bleeding than warfarin and did not require routine monitoring, see FAC ¶ 98(c). Each and every one of those representatio s is true and consistent with FDA’s medical review and the FDA-approved label. First, Eliquis was approved by FDA as “safe and effective” for the trea ment of nonvalvular atrial fibrillation, based on the results of its Phase III studies.22 See App. at 11, 27-32 (Dec. 2012 Eliquis Label at 2, 18-23). If FDA did not conclude that Eliquis was effective for this indication, it would not have approved the medication.23 Second, FDA’s pre-approval medical review concluded that Eliquis “was superior to warfarin for the primary efficacy and safety endpoints as well as mortality” and approved a label that states that Eliquis “was superior to warfarin for the primary endpoint of reducing the risk of stroke and systemic embolism . . . [and] showed significantly 22 With regard to Plaintiff’s claims about the ARISTO LE trial, it is important to reiterate that FDA carefully evaluated the conduct of the study and its results. FDA determined that concerns related to the design and conduct of the trial had been addressed by BMS and did not affect the overall outcomes of the study or FDA’s con lusions about the safety and efficacy of Eliquis. After completing its review, FDA approved the Eliquis label containing a summary of the results from ARISTOTLE, which Plaintiff now describes as fraudulent. 23 FDA may only approve a drug if it finds that the drug “is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof” and “will have the effect it purports or is represented to have.” 21 U.S.C.A. § 355(d)(1-5). Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 32 of 34 PageID 861 25 fewer major bleeds than warfarin.” See App. at 193, 28 (Apixaban Medical Reviews at 54; Dec. 2012 Eliquis Label at 19). Third, while warfarin requires routine monitoring, FDA approved Eliquis without the need for such monitoring. For all of these reasons, Plaintiff’s fraud claims should be dismissed. VI. Plaintiff’s Loss of Consortium, Wrongful Death, and Survival Action Theories Fail Because They Are Derivative of Plaintiff’s Other Claims. Finally, because all of Plaintiff’s other claims fail, her loss of consortium, wrongful death, and survival action claims fail as well, because such claims are derivative of Plaintiff’s underlying claims. See Upjohn Co. v. Freeman, 885 S.W.2d 538, 549 (Tex. App. 1994); Johnson v. TDS Erectors, Inc., 426 F. App’x 241, 242 (5th Cir. 2011); Hendricks v. Ford Motor Co., No. 4:12CV71, 2012 WL 7956426, at *5 (E.D. Tex. Aug. 24, 2012). Therefore, when a court grants judgment as to a plaintiff’s underlying claims, such derivative claims “must also fail as a matter of law.” Koenig v. Purdue Pharma Co., 435 F. Supp. 2d at 557-58; see also McKay I, 934 F. Supp. 2d at 915, aff’d McKay II, 751 F.3d 694 (5th Cir. 2014). CONCLUSION For the reasons discussed above, Plaintiff’s First Amended Complaint should be dismissed in its entirety because Plaintiff’s claims are preempted under Texas and federal law and to the extent they may not be preempted, otherwis fail to satisfy Fed. R. Civ. P. 12(b)(6) and 9(b). Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 33 of 34 PageID 862 26 Dated: September 6, 2016 Respectfully submitted, /s/ Eliot Burriss Eliot Burriss Texas Bar No. 24040611 eli.burriss@dlapiper.com Nicole Figueroa Texas Bar No. 24069716 Nicole.figueroa@dlapiper.com DLA Piper LLP (US) 1717 Main Street, Suite 4600 Dallas, Texas 75201 (214) 743-4500 – telephone (214) 743-4545 – facsimile Loren H. Brown (admitted pro hac vice) loren.brown@dlapiper.com Cara D. Edwards (admitted pro hac vice) cara.edwards@dlapiper.com DLA Piper LLP (US) 1251 Avenue of the Americas, 45th Floor New York, NY 10020 (212) 335-4500 – telephone (212) 335-4501 – facsimile Matthew A. Holian (admitted pro hac vice) matt.holian@dlapiper.com DLA Piper LLP (US) 33 Arch Street, 26th floor Boston, MA 02110 (617) 406-6009 – telephone (617) 406-6109 – facsimile COUNSEL FOR DEFENDANTS Case 3:16-cv-00681-B Document 73 Filed 09/06/16 Page 34 of 34 PageID 863 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS DALLAS DIVISION BEVERLY KAYE GRAHAM ORR, as Executrix of the Estate of Robin Orr and Individually, Plaintiff, v. BRISTOL-MYERS SQUIBB CO. and PFIZER, INC., Defendants. § § § § § § § § § § § § § CIVIL ACTION NO. 3:16-cv-00681-B HONORABLE JANE J. BOYLE DEFENDANTS BRISTOL-MYERS SQUIBB COMPANY AND PFIZER INC.’S REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS AMENDED COMPLAINT PURSUANT TO FED R. CIV. P. 12(b)( 6) AND 9(b) Pursuant to Federal Rule of Evidence 201(c)(2), defendants Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”) (collectively, “Defendants”) respectfully request that the Court take judicial notice of the approval of the medication Eliquis (Apixaban) for various indications by the U.S. Food & Drug Administration (“FDA”), the labels and Medication Guide for Eliquis reflecting those approved indications and containing the warnings and instructions for the use of Eliquis, FDA’s Medical Review and Summary Review for Eliquis, and statements on FDA’s website regarding the New Drug Application (“NDA”) process. In support of their request, Defendants state: 1. FDA lists approved medications on its website, which can be accessed at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. The approved drug list can be searched by entering “Eliquis,” which yields details for the medication Eliquis (NDA 202155). By clicking on “Label Information,” a table containing the approval history for Eliquis can be Case 3:16-cv-00681-B Document 73-2 Filed 09/06/16 Page 1 of 7 PageID 1424 DEFENDANTS’ REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS Page 2 accessed (the “Eliquis Approval Table”). The relevant action dates are listed in reverse chronological order in the table. 2. The Eliquis Approval Table on FDA’s website lists documents relevant to the December 28, 2012 initial approval of Eliquis for an indication to reduce the risk of stroke and systemic embolism (blood clots) in patients with nonvalvular atrial fibrillation. True and correct copies of FDA’s December 28, 2012 approval letter to Bristol-Myers Squibb Company, along with the original approved label for Eliquis, both accessible through the Eliquis Approval Table, are attached as Appendix Exhibits 1 and 2, respectively. 3. The Eliquis Approval Table on FDA’s website lists documents relevant to the March 13, 2014 approval of Eliquis for an indication f r the prophylaxis of deep vein thrombosis (DVT) which may lead to pulmonary embolism (PE) in adult patients who have undergone hip or knee replacement surgery. True and correct copies of FDA’s March 13, 2014 approval letter to Bristol-Myers Squibb Company, along with the revis d label for Eliquis reflecting the newly approved indication, both accessible through the Eliquis Approval Table, are attached as Appendix Exhibits 3 and 4, respectively. 4. The Eliquis Approval Table on FDA’s website lists documents relevant to the August 21, 2014 approval of Eliquis for an indication for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy. True and correct copies of FDA’s August 21, 2014 approval letter to Bristol-Myers Squibb Company, along with the revised label for Eliquis reflecting the newly approved indication, both accessible through the Eliquis Approval Table, are attached as Appendix Exhibits 5 and 6, respectively. Case 3:16-cv-00681-B Document 73-2 Filed 09/06/16 Page 2 of 7 PageID 1425 DEFENDANTS’ REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS Page 3 5. The FDA website also contains FDA’s medical reviews for Eliquis, located at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/ 02155Orig1s000MedR.pdf. A true and correct copy of FDA’s medical reviews for Eliquis is attached as Appendix Exhibit 7. 6. The FDA website also contains information on theN w Drug Application process, through which, inter alia, FDA determines whether a medication is safe and effective for a particular use or uses. For example, the websit contains a general description of FDA’s product approval process,1 as well as a summary of the New Drug Application process.2 True and correct copies of these pages on the FDA website are attached as Appendix Exhibits 8 and 9, respectively. 7. The FDA website also contains the December 28, 2012 Summary Review for Eliquis (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202155Orig1s000SumR.pdf), recommending that Eliquis be approved for reducing the rate of stroke on systemic embolism in patients with nonvalvular atrial fibrillation. A true and correct copy of the Eliquis Summary Review is attached as Appendix Exhibit 10. 8. Because FDA communications, approvals and labels, as well as information posted by FDA on its website are matters of public record that can be “accurately and readily determined from sources whose accuracy cannot reasonably be questioned” and thus are “not subject to reasonable dispute,” Fed. R. Evid. 201(b), the Court may take judicial notice of them, without converting Defendants’ Motion to Dismiss into one for summary judgment. See Lewis v. Wells Fargo Bank, N.A., 939 F. Supp. 2d 634, 637 n.3 (N.D. Tex. 2013) (“The court may take 1 “About FDA Product Approval,” available at http://www.fda.gov/NewsEvents/ProductsApprovals/ucm106288.htm. 2 “New Drug Application (NDA),” available at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ ApprovalApplications/NewDrugApplicationNDA/default.h m Case 3:16-cv-00681-B Document 73-2 Filed 09/06/16 Page 3 of 7 PageID 1426 DEFENDANTS’ REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS Page 4 judicial notice of matters of public record, and also take into account matters referenced in and attached to the plaintiff's complaint, without converting a motion to dismiss to a motion for summary judgment.”) (citing Randall D. Wolcott, M.D., P.A. v. Sebelius, 635 F.3d 757, 763 (5th Cir.2011)); Dinsdale v. Ad TelAmerica Inc., No. 3:14-CV-3427-B, 2015 WL 1757473, at *5 n.3 (N.D. Tex. Apr. 17, 2015) (Boyle, J.) (“[I]t is well-established that in deciding a Rule 12(b)(6) motion to dismiss, a court may properly consider the complaint, its proper attachments, documents incorporated into the complaint by reference, and matters of which a court may take judicial notice.”) (citation and internal quotations omitted). 9. Indeed, courts in this Circuit regularly take judicial notice of FDA approvals and labels, as well as information on the FDA website. S e Bass v. Stryker Corp., 669 F.3d 501, 507 (5th Cir. 2012) (stating that “documents describing the FDA's approval process are subject to judicial notice”); Funk v. Stryker Corp., 631 F.3d 777, 783 (5th Cir. 2011) (taking judicial notice of publicly-available documents produced by FDA, “which were matters of public record directly relevant to the issue at hand”); Morgan v. Medtronic, Inc., No. 3:15-CV-32, 2016 WL 1162400, at *4 n.4 (S.D. Tex. Mar. 23, 2016) (taking judicial notice of information on FDA websites because FDA documents “are public government r cords that are not subject to reasonable dispute”); Cooper v. Pfizer, Inc., No. CIV.A. H-14-3705, 2015 WL 2341888, at *2 (S.D. Tex. May 13, 2015) (taking judicial notice of the contents of FDA-approved label for Lipitor); Lamkin v. Cockrell, No. CIV.SA-02-CA-0436-XR, 2003 WL 22244962, at *3n.1 (W.D. Tex. Sept. 30, 2003) (taking judicial notice of FDA approval of medication for particular indications).3 3 See also In re Avandia Mktg. Sales Practices & Products Liab. Litig., 588 F. App'x 171, 174 (3d Cir. 2014) (“Because [plaintiff’s] complaint explicitly refers to Avandia's ‘labels’ and those documents are publicly available on the FDA's website, we may take judicial notice of the Case 3:16-cv-00681-B Document 73-2 Filed 09/06/16 Page 4 of 7 PageID 1427 DEFENDANTS’ REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS Page 5 For the foregoing reasons, Defendants respectfully request that the Court take judicial notice of the approval of the medication Eliquis (Apixaban) for various indications by FDA, the labels and Medication Guide for Eliquis reflecting those approved indications and containing the warnings and instructions for the use of Eliquis, FDA’s Medical Review and Summary Review for Eliquis, and statements on FDA’s website regarding the New Drug Application process. labels' content.”); Becker v. Cephalon, Inc., No. 14 CIV. 3864 NSR, 2015 WL 5472311, at *3 (S.D.N.Y. Sept. 15, 2015) (taking judicial notice of FDA-approved labels because they “are public documents” and “can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.”); In re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig., 590 F. Supp. 2d 1282, 1286 (C.D. Cal. 2008) (taking judicial notice of labels on FDA’s website). Case 3:16-cv-00681-B Document 73-2 Filed 09/06/16 Page 5 of 7 PageID 1428 DEFENDANTS’ REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS Page 6 Dated: September 6, 2016 Respectfully submitted, _/s/ Eliot Burriss________________________ Eliot Burriss Texas Bar No. 24040611 eli.burriss@dlapiper.com Nicole Figueroa Texas Bar No. 24069716 Nicole.figueroa@dlapiper.com DLA Piper LLP (US) 1717 Main Street, Suite 4600 Dallas, Texas 75201 (214) 743-4500 – telephone (214) 743-4545 – facsimile Loren H. Brown (admitted pro hac vice) loren.brown@dlapiper.com Cara D. Edwards (admitted pro hac vice) cara.edwards@dlapiper.com DLA Piper LLP (US) 1251 Avenue of the Americas, 45th Floor New York, NY 10020 (212) 335-4500 – telephone (212) 335-4501 – facsimile Matthew A. Holian (admitted pro hac vice) matt.holian@dlapiper.com DLA Piper LLP (US) 33 Arch Street, 26th floor Boston, MA 02110 (617) 406-6009 – telephone (617) 406-6109 – facsimile COUNSEL FOR DEFENDANTS Case 3:16-cv-00681-B Document 73-2 Filed 09/06/16 Page 6 of 7 PageID 1429 CERTIFICATE OF SERVICE I hereby certify that on this 6th day of September 2016, I caused a true and correct copy of the foregoing REQUEST FOR JUDICIAL NOTICE to be s rved on the following counsel via operation of the Court’s electronic CM/ECF system: Robert Wolf Les Weisbrod Miller Weisbrod LLP 11551 Forest Central Drive, Suite 300 Dallas, TX 75243 (214) 987-0005 – telephone (214) 987-2545 – facsimile rwolf@millerweisbrod.com lweisbrod@millerweisbrod.com Michael P. Koskoff Koskoff, Koskoff & Bieder, P.C. 350 Fairfield Ave. Bridgeport, CT 06604 (203) 336-4421 – telephone mkoskoff@koskoff.com Counsel for Plaintiff Beverly Kaye Graham Orr (Executrix of the Estate of Robin Orr and Individually) _/s/ Eliot Burriss______________ Eliot Burriss Texas Bar No. 24040611 Attorney for Defendants Bristol-Myers Squibb Company and Pfizer Inc. Case 3:16-cv-00681-B Document 73-2 Filed 09/06/16 Page 7 of 7 PageID 1430