Denise Harrison v. Bayer Corporation et al

NOTICE OF MOTION AND MOTION to Dismiss Case /Plaintiff's First Amended Complaint; Memorandum of Points and Authorities in Support Thereof

C.D. Cal.December 8, 2016

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 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES Alycia A. Degen, SBN 211350 adegen@sidley.com Bradley J. Dugan, SBN 271870 bdugan@sidley.com SIDLEY AUSTIN LLP 555 West Fifth Street, Suite 4000 Los Angeles, California 90013 Telephone: +1 213 896-6000 Facsimile: +1 213 896-6600 Attorneys for Defendants Bayer Essure Inc., Bayer Corporation, Bayer HealthCare LLC, and Bayer HealthCare Pharmaceuticals Inc. [Additional counsel on signature page] UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA DENISE HARRISON, Plaintiff, v. BAYER CORP., BAYER HEALTHCARE LLC, BAYER ESSURE INC.; BAYER HEALTHCARE PHARMACEUTICALS, INC.; and DOES 1-10, inclusive, Defendants. Case No. 16-cv-01958-MWF (MRWx) DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S FIRST AMENDED COMPLAINT; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF [Filed concurrently with Request for Judicial Notice; [Proposed] Order] Date: February 13, 2017 Time: 10:00 a.m. Location: Courtroom 9C Judge: Hon. Michael W. Fitzgerald Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 1 of 32 Page ID #:174 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on February 13, 2017, at 11:00 a.m., or as soon as thereafter as this matter may be heard in the United States District Court for the Central District of California, 312 North Spring Street, Courtroom 1600 (16th Floor), Los Angeles, CA 90012, Defendants Bayer Essure Inc., Bayer HealthCare LLC, Bayer Corporation, and Bayer HealthCare Pharmaceuticals Inc. (collectively, “Bayer”), will and hereby do move to dismiss Plaintiff’s First Amended Complaint, pursuant to Federal Rules of Civil Procedure 8, 9(b), and 12(b)(6), on the grounds that Plaintiff’s claims are preempted by federal law and fail to satisfy federal pleading standards. Bayer’s Motion is based on this Notice of Motion and Motion, its Memorandum of Points and Authorities, its Request for Judicial Notice, and all attached exhibits, all other papers and pleadings on file, and argument of counsel at any hearing of this Motion. This Motion is filed following a conference of counsel pursuant to Local Rule 7-3. The parties discussed Bayer’s intended motion by phone on December 5, 2016, and were unable obviate the need for this Motion.1 1 The parties also have had previous discussions with respect to Plaintiff’s claims. Plaintiff filed an initial complaint in Orange County, CA, on September 2, 2016, but attached an improper summons captioned for Clark County, NV, that purported to serve Bayer on September 27, 2016. Bayer removed the case to this Court on October 27, 2016, on the basis of diversity jurisdiction. Thereafter, the parties discussed Bayer’s proposed motion to dismiss Plaintiff’s original complaint and Plaintiff requested an opportunity to amend her complaint. Plaintiff filed an Amended Complaint on November 21, 2016. The parties again conferred with respect to this Motion to Dismiss on December 5, 2016. Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 2 of 32 Page ID #:175 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 2 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES Dated: December 8, 2016 SIDLEY AUSTIN LLP By: /s/ Alycia A. Degen Alycia A. Degen Bradley J. Dugan SIDLEY AUSTIN LLP 555 West Fifth Street Los Angeles, CA 90013 (213) 896-6682 (213) 896-6600 (fax) adegen@sidley.com bdugan@sidley.com Rebecca K. Wood (Pro Hac Vice to be filed) Jonathan F. Cohn (Pro Hac Vice to be filed) SIDLEY AUSTIN LLP 1501 K Street, N.W. Washington, DC 20005 Telephone: (202) 736-8000 Facsimile: (202) 736-8711 rwood@sidley.com jfcohn@sidley.com Maja C. Eaton (Pro Hac Vice to be filed) meaton@sidley.com SIDLEY AUSTIN LLP One South Dearborn Chicago, IL 60603 Telephone: (312) 853-7000 Facsimile: (312) 853-7036 Attorneys for Bayer Essure Inc. Bayer Corporation, Bayer HealthCare LLC, and Bayer HealthCare Pharmaceuticals, Inc. Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 3 of 32 Page ID #:176 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 i NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES TABLE OF CONTENTS INTRODUCTION ......................................................................................................... 1 BACKGROUND ........................................................................................................... 2 A. Statutory And Regulatory Background .......................................... 2 B. Factual Background ........................................................................ 4 LEGAL STANDARD .................................................................................................... 6 ARGUMENT ................................................................................................................. 6 I. FEDERAL LAW PREEMPTS PLAINTIFF’S CLAIMS. ....................... 6 A. Plaintiff’s Claims Based On An Alleged Failure To Train Physicians Are Expressly Preempted. ............................................ 8 B. Plaintiff’s Claims Based On Alleged Misrepresentations And Warranties Are Expressly Preempted. .................................... 9 C. Plaintiff’s Claims Based On An Alleged Defect In The Manufacturing Process Are Expressly And Impliedly Preempted. .................................................................................... 12 D. Plaintiff’s Claims Based On An Alleged Failure To Warn Are Expressly And Impliedly Preempted. .................................... 17 II. PLAINTIFF FAILS TO STATE ANY VALID CLAIM UNDER CALIFORNIA LAW. ............................................................... 21 A. Plaintiff Fails To Plead Causation Adequately. ............................ 21 B. Plaintiff Fails To Plead Her Fraud-Based Claims With Particularity. .................................................................................. 22 CONCLUSION ............................................................................................................ 24 Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 4 of 32 Page ID #:177 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 ii NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES TABLE OF AUTHORITIES Page(s) Cases Ala. Tissue Ctr. of Univ. of Ala. Health Serv. Found., P.C. v. Sullivan, 975 F.2d 373 (7th Cir. 1992) ..................................................................................... 3 Ashcroft v. Iqbal, 556 U.S. 662 (2009)....................................................................................... 6, 16, 22 Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007)....................................................................................... 6, 21, 22 Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001)........................................................................................... 2, 4, 7 Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015) ........................................................................... 4, 17 Cohen v. Guidant Corp., No. 05-8070, 2011 WL 637472 (C.D. Cal. Feb. 15, 2011) ..................................... 13 De La Paz v. Bayer Healthcare LLC, 159 F. Supp. 3d 1085 (N.D. Cal. 2016) ............................................................ passim Fields v. Legacy Health Sys., 413 F.3d 943 (9th Cir. 2005) ..................................................................................... 6 Frere v. Medtronic, Inc., No. 15-2338, 2016 WL 1533524 (C.D. Cal. Apr. 6, 2016) ................................. 8, 13 Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919 (5th Cir. 2006) ................................................................................... 17 Herrington v. Johnson & Johnson Consumer Cos., No. 09-cv-1597, 2010 WL 3448531 (N.D. Cal. Sept. 1, 2010) .............................. 23 Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y. 2009) ....................................................... 7, 8, 13, 21 Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal. 2013) ..................................................................... 7 Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 5 of 32 Page ID #:178 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 iii NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582 (E.D.N.Y. 2009) ..................................................................... 13 Kearns v. Ford Motor Co., 567 F.3d 1120 (9th Cir. 2009) ............................................................................. 6, 22 King v. Collagen Corp., 983 F.2d 1130 (1st Cir. 1993) .................................................................................. 17 Lance v. Bayer Essure Inc., No. RG16809860, slip op. (Cal. Super. Ct. Aug. 2, 2016) (RJN Ex. R) ............ 1, 17 McConologue v. Smith & Nephew, Inc., 8 F. Supp. 3d 93 (D. Conn. 2014).............................................................................. 7 McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804 (E.D. Pa. 2016) ................................................................ passim McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 2005) ................................................................................... 18 Medali v. Bayer HealthCare LLC., No. RG15771555 (Cal. Super Ct. Feb. 16, 2016) (RJN Ex. B) ................................ 1 In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) ......................................................... 12, 13, 17, 18, 21 Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)................................................................................................... 4 Noris v. Bayer Essure, Inc., No. BC589882 (Cal. Super. Ct. Apr. 26, 2016) ........................................................ 1 Norman v. Bayer Corp., No. 3:16-cv-00253 (JAM), 2016 WL 4007547 (D. Conn. July 26, 2016) ................................................................................................................. passim Perez v. Nidek Co., Ltd., 711 F.3d 1109 (9th Cir. 2013) ............................................................................. 8, 17 Pinsonneault v. St. Jude Med., Inc., 953 F. Supp. 2d 1006 (D. Minn. 2013) ................................................................... 11 Richardson v. Bayer HealthCare Pharms. Inc., No. 4:15-cv-00443, 2016 WL 4546369 (D. Idaho Aug. 30, 2016)1, 6, 11, 12, 14, 16 Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 6 of 32 Page ID #:179 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 iv NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)..................................................................................... 2, 3, 7, 17 Rosburg v. Minnesota Mining & Mfg. Co., 226 Cal. Rptr. 299 (Ct. App. 1986) ......................................................................... 19 Sprewell v. Golden State Warriors, 266 F.3d 979 (9th Cir 2001) ...................................................................................... 6 Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) ........................................................................... 18, 21 Tapia v. Davol, Inc., 116 F. Supp. 3d 1149 (S.D. Cal. 2015) ................................................................... 22 U.S. Concord, Inc. v. Harris Graphics Corp., 757 F. Supp. 1053 (N.D. Cal. 1991) ........................................................................ 23 UMG Recordings, Inc. v. Global Eagle Entm’t, Inc., 117 F. Supp. 3d 1092 (C.D. Cal. 2015) ................................................................... 22 Williams v. Bayer Corp., No. 15BA-CV02526 (Mo. Cir. Ct. July 18, 2016) .................................................... 1 Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) ............................................................................... 17 Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006) .................................................................................... 2, 3 Statutes 21 U.S.C. §§ 332, 333, 334 ............................................................................................. 4 21 U.S.C. § 337(a) .......................................................................................................... 4 21 U.S.C. §§ 360c(a)(1)(C)(i)-(ii) .................................................................................. 2 21 U.S.C. § 360e(c)(1)(H) .............................................................................................. 3 21 U.S.C. § 360e(d)(6)(A)(i) .......................................................................................... 3 21 U.S.C. § 360k(a) .............................................................................................. 2, 7, 11 21 U.S.C. § 360k(a)(1) .................................................................................................... 7 Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 7 of 32 Page ID #:180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 v NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES Other Authorities 21. C.F.R. § 814.39(d) .................................................................................................. 18 21 C.F.R. § 814.44(c) ..................................................................................................... 3 21 C.F.R. § 820.30 .................................................................................................. 12, 14 21 C.F.R. § 820.198(b) ................................................................................................. 19 Fed. R. Civ. P 8, 9(b), and 12(b)(6) .............................................................................. 24 Fed. R. Civ. P. 9(b) ............................................................................................. 6, 22, 23 H.R. Rep. No. 94-853 (1976) ......................................................................................... 2 Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 8 of 32 Page ID #:181 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES MEMORANDUM OF POINTS AND AUTHORITIES INTRODUCTION The Amended Complaint should be dismissed because Plaintiff’s claims are preempted by federal law and do not meet federal pleading standards. Four federal courts have addressed highly similar claims: two dismissed all of them; the other two dismissed almost all of them. See, e.g., De La Paz v. Bayer Healthcare LLC, 159 F. Supp. 3d 1085 (N.D. Cal. 2016) (dismissing all claims with leave to amend certain claims after which plaintiffs voluntarily dismissed); Norman v. Bayer Corp., No. 3:16- cv-00253 (JAM), 2016 WL 4007547 (D. Conn. July 26, 2016) (dismissing all claims with prejudice); Richardson v. Bayer HealthCare Pharms. Inc., No. 4:15-cv-00443, 2016 WL 4546369 (D. Idaho Aug. 30, 2016) (dismissing all claims except one, with leave to amend one claim, after which plaintiffs voluntarily dismissed); McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804, 838 (E.D. Pa. 2016) (dismissing 10 of 12 claims, with leave to amend certain claims). Plaintiffs have fared no better in state courts. See Williams v. Bayer Corp., No. 15BA-CV02526 (Mo. Cir. Ct. July 18, 2016) (claims dismissed with prejudice) (order attached as Exhibit A to concurrently filed Request for Judicial Notice (“RJN”)); Medali v. Bayer HealthCare LLC., No. RG15771555 (Cal. Super Ct. Feb. 16, 2016) (demurrer sustained with leave to amend certain claims) (RJN Ex. B); Noris v. Bayer Essure, Inc., No. BC589882, (Cal. Super. Ct. Apr. 26, 2016) (demurrer sustained with leave to amend two claims) (docket attached as Exhibit C to RJN); Lance v. Bayer Essure Inc., No. RG16809860, slip op. (Cal. Super. Ct. Aug. 2, 2016) (demurrer sustained in part with leave to amend certain claims) (RJN Ex. R). Courts have had no trouble dismissing the claims at issue because, at bottom, Plaintiff is attempting to second-guess the United States Food & Drug Administration (“FDA”). FDA has the exclusive authority to regulate Class III medical devices like Essure, and has decided-numerous times-that Essure is safe and effective. FDA has balanced the benefits and risks of the device and recently confirmed that “Essure Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 9 of 32 Page ID #:182 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 2 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES remains an appropriate option for the majority of women seeking a permanent form of birth control.” FDA, FDA Takes Additional Action to Better Understand Safety of Essure, Inform Patients of Potential Risks, News Release (Feb. 29, 2016) (RJN Ex. D). Consistent with the wealth of precedent, this Court should dismiss the Amended Complaint because each claim is preempted or otherwise fails. BACKGROUND A. Statutory And Regulatory Background Federal law grants FDA the exclusive power to regulate medical devices. In 1976, Congress enacted the Medical Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”). The legislation “swept back” much of the state regulation that had emerged in patchwork form, and instead “imposed a regime of detailed federal oversight.” Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). As part of this regime, Congress adopted a “general prohibition on non-Federal regulation” to avert the “undu[e] burden[]” of differing state regulations that can stifle innovation and ultimately harm public health. H.R. Rep. No. 94-853, at 45 (1976). Congress preempted all state laws that impose “any requirement” relating to the safety or effectiveness of a medical device that “is different from, or in addition to, any requirement applicable . . . to the device” under federal law. 21 U.S.C. § 360k(a). Instead of state regulation, FDA provides the necessary oversight. Under this regime, “each medical device is classified according to the stringency of regulatory control necessary to ensure safety and effectiveness.” Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71, 74 (2d Cir. 2006). A device intended “for a use in supporting or sustaining human life,” or that otherwise “presents a potential unreasonable risk of illness or injury” is deemed a Class III device. 21 U.S.C. §§ 360c(a)(1)(C)(i)-(ii). FDA subjects a small percentage of innovative Class III devices, such as Essure, to the most “rigorous” level of FDA scrutiny. These devices must receive Premarket Approval (“PMA”) before they can be marketed or sold. Riegel, 552 U.S. at 318; Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 344 (2001). Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 10 of 32 Page ID #:183 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 3 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES To receive such approval, the device manufacturer “must submit what is typically a multivolume application,” and the “FDA spends an average of 1,200 hours reviewing each application,” ultimately “grant[ing] premarket approval only if it finds there is a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.’” Riegel, 552 U.S. at 317-18 (quoting 21 U.S.C. § 360e(d)); see also Ala. Tissue Ctr. of Univ. of Ala. Health Serv. Found., P.C. v. Sullivan, 975 F.2d 373, 374-75 (7th Cir. 1992) (describing premarket approval process). A “manufacturer must furnish” numerous materials to FDA, including “detailed information about the device’s testing, design, components, performance standards, manufacturing, packaging, and labeling.” Leavitt, 470 F.3d at 74. FDA then heavily scrutinizes these applications, “‘weigh[ing] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.’” Riegel, 552 U.S. at 318 (quoting 21 U.S.C. § 360c(a)(2)(C)). As part of this process, FDA reviews a device’s proposed labeling, which includes the Instructions for Use (“IFU”) (for physicians) and Patient Information Booklet (“PIB”) (for patients). The agency “evaluates safety and effectiveness under the conditions of use set forth on the label,” and “must determine that the proposed labeling is neither false nor misleading” before granting approval. Id. at 318 (citing 21 U.S.C. §§ 360c(a)(2)(B), 360e(d)(1)(A)). Once a device has been approved, a manufacturer cannot make changes to the labeling without FDA permission, 21 U.S.C. § 360e(d)(6)(A)(i), under “largely the same criteria” as the initial application. Riegel, 522 U.S. at 319 (citing 21 U.S.C. § 360e(d)(6); 21 C.F.R. § 814.39(c)). The statute likewise “forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id. (citing 21 U.S.C. § 360e(d)(6)(A)(i)). FDA may demand additional information from the manufacturer at any time, see 21 U.S.C. § 360e(c)(1)(H), and may require revisions to any component of the application, see 21 C.F.R. § 814.44(c). Only upon successfully “running the gauntlet of the PMA Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 11 of 32 Page ID #:184 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 4 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES process,” Medtronic, Inc. v. Lohr, 518 U.S. 470, 494 (1996), may a Class III device lawfully be marketed in the United States. A device manufacturer’s obligations under federal law do not end with pre- market approval. See Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1336 (10th Cir. 2015). By design, FDA enjoys wide and exclusive enforcement authority. Congress has made clear that actions to enforce the FDCA “shall be by and in the name of the United States,” 21 U.S.C. § 337(a), and this judgment forecloses any private right of action under that statute, see Buckman, 531 U.S. at 349 n.4. FDA may investigate manufacturers of drugs and devices, and the agency “has at its disposal a variety of enforcement options that allow it to make a measured response” to any violations it uncovers. Buckman, 531 U.S. at 349; see also 21 U.S.C. §§ 332, 333, 334. B. Factual Background 1. FDA’s Approval of Essure Since 2002, FDA has recognized that Essure is a safe and effective method of permanent contraception for women. Essure consists of two “micro-inserts” that are placed in a patient’s fallopian tubes by her physician. See RJN Ex. E at 4 (FDA, Premarket Approval Order, Essure System); RJN Ex. F (“Summary of Safety and Effectiveness Data” for Essure System). Since approving Essure as a Class III device through the PMA process in 2002, FDA has never withdrawn its approval. See, e.g., RJN Ex. E (PMA); RJN Ex. F (Summary); RJN Ex. N (FDA Activities). Instead, it has granted numerous supplemental approvals, including as recently as November 2016, see RJN Ex. M (FDA, 2016 PMA Supplement), and has repeatedly reviewed and approved Essure’s design, construction, manufacturing, testing, training requirements, warnings, instructions for use, patient information, and all other labeling. FDA recognizes that Essure (like all Class III medical devices) presents some risks, but has repeatedly concluded that the benefits of Essure outweigh these risks, which are disclosed in the FDA-approved and mandated labeling. Among other risks, Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 12 of 32 Page ID #:185 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 5 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES Essure’s labeling states that some women may experience “pelvic, back, or abdominal pain,” RJN Ex. I (2008 PIB) at 15; warns that uterine or tubal perforation may occur, e.g., id. at 13,15; RJN Ex. J (2008 IFU), at 1-2; and advises that “you should NOT use the Essure permanent birth control system if you . . . “[h]ave a sensitivity to nickel as shown by skin testing,” RJN Ex. I (2008 PIB) at 8. See also RJN Ex. J (2008 IFU) at 1 (requiring skin test for nickel hypersensitivity); id. at 2 (disclosing observed and potential adverse effects); RJN Ex. K (2002 PIB) at 14-17. The labeling further discloses that “if device removal is indicated, this will require surgery.” See RJN Ex. J (2008 IFU) at 2; RJN Ex. L (2002 IFU) at 5. Recently, after holding a public hearing in September 2015, the agency rejected challenges to the device, reaffirming that “FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control,” RJN Ex. D (FDA News Release), and concluding that “[t]o date, [it has] found no conclusive evidence in the literature indicating any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement,” RJN Ex. N (FDA Activities) at 5. 2. Plaintiff’s Procedure Plaintiff claims that she had an Essure device placed on September 20, 2010. Am. Compl. ¶ 112. She alleges that she chose the device based on unspecified “selling points in the Defendants’ brochure.” Id. ¶¶ 111-12. Despite the disclosure of Essure’s nickel content and directive to physicians to conduct a nickel hypersensitivity skin test in Essure’s labeling, see, e.g., RJN Ex. J (2008 IFU) at 1, Plaintiff alleges that she “was not given a hypersensitivity nickel allergy skin test by her doctor,” and that her doctor recommended the device even though Ms. Harrison had a “suspected or previous diagnosis of hypersensitive nickel allergy.” Id. ¶ 122. Following the placement procedure, Plaintiff allegedly experienced complications including nickel poisoning, abdominal pain, heavy bleeding, and uterine perforation. Id. ¶ 114. Plaintiff allegedly underwent a vaginal hysterectomy with bilateral salpingectomy Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 13 of 32 Page ID #:186 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 6 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES (fallopian tube removal) on September 8, 2015, to remove her Essure device. Id. ¶¶ 115-16. Plaintiff filed this action in state court, and Bayer timely removed the action to this Court based on diversity jurisdiction on October 27, 2016. Plaintiff subsequently amended the Complaint to assert four causes of action: (1) failure to warn; (2) negligence; (3) strict products liability; and (4) fraud. LEGAL STANDARD A Rule 12(b)(6) motion to dismiss should be granted if a plaintiff is unable to articulate “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). “[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.” Id. at 545. “Nor does a complaint suffice if it tenders ‘naked assertion[s]’ devoid of ‘further factual enhancement.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Twombly). The Court is “not required to accept as true conclusory allegations which are contradicted by documents referred to in the complaint,” Sprewell v. Golden State Warriors, 266 F.3d 979, 990 (9th Cir 2001) (citations omitted), or any “unwarranted inferences,” Fields v. Legacy Health Sys., 413 F.3d 943, 950 n.5 (9th Cir. 2005). Moreover, fraud-based claims must be pled with particularity. See Fed. R. Civ. P. 9(b). Kearns v. Ford Motor Co., 567 F.3d 1120, 1125 (9th Cir. 2009). ARGUMENT I. FEDERAL LAW PREEMPTS PLAINTIFF’S CLAIMS. As other federal courts have held in dismissing similar complaints involving Essure, Plaintiff’s claims are preempted and fail as a matter of law. See De La Paz, 159 F. Supp. 3d 1085; Richardson, 2016 WL 4546369; Norman, 2016 WL 4007547; see also McLaughlin, 172 F. Supp. 3d 804.2 Federal law expressly preempts any state 2 These decisions analyze the issues under the rubric of both preemption and federal pleading standards. See, e.g., Norman, 2016 WL 4007547, at *5; McLaughlin, 172 F. Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 14 of 32 Page ID #:187 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 7 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES tort claim against a pre-market approved, Class III medical device such as Essure that would impose requirements “different from, or in addition to, any requirement” imposed by FDA. 21 U.S.C. § 360k(a)(1); Riegel, 552 U.S. at 321; De La Paz, 159 F. Supp. 3d at 1091; Norman, 2016 WL 4007547, at *2. Thus, Plaintiff’s claims are expressly preempted unless she adequately alleges a violation of FDA “requirements related to” her device, as well as “a causal nexus between the alleged injury and the violation” of federal requirements. Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1174 (C.D. Cal. 2013); accord Riegel, 552 U.S. at 330; De La Paz, 159 F. Supp. 3d at 1091; Norman, 2016 WL 4007547, at *2; see also Noris, No. BC589882, Tr. at 25:20- 25 (excerpt at RJN Ex. C); Williams, No. 15BA-CV0252, at 1 (RJN Ex. A). In addition, because FDA has extensive and exclusive authority to enforce its own requirements, federal law impliedly preempts claims based solely on the violation of FDA requirements. Buckman, 531 U.S. at 349 n.4. Plaintiff cannot second-guess FDA or its decision on how to enforce those requirements. See Riegel, 552 U.S. at 343; De La Paz, 159 F. Supp. 3d at 1091-92; McConologue v. Smith & Nephew, Inc., 8 F. Supp. 3d 93, 101 (D. Conn. 2014) (a “claim may be impliedly preempted when the state-law claim is in substance (even if not in form) a claim for violating the FDCA-that is, when the state claim would not exist if the FDCA did not exist”). Thus, state-law claims concerning medical devices with pre-market approval- such as Essure-are preempted unless they fit within a “narrow gap”: “The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).” Supp. 3d at 836. Under both analyses, the result is the same: the claims fail as a matter of law and must be dismissed. Further, the two issues are interrelated. A failure to plead adequately that violation of a federal requirement caused the particular plaintiff’s injuries, for instance, results in both a failure to state a claim under federal pleading standards and preemption. See Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 282 (E.D.N.Y. 2009). While we focus on the complaint’s deficiencies as a matter of federal preemption, the claims are also inadequately pled for largely the same reasons. See, e.g., infra at 19-20. Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 15 of 32 Page ID #:188 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 8 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th Cir. 2013) (quoting In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010)). To fit within this narrow gap, Plaintiff must plead, and ultimately prove, that (1) Bayer violated a federal requirement; (2) this federal violation also violates an independent and “parallel” state law requirement; and (3) the federal violation caused Plaintiff’s own injury. Id; see also De La Paz, 159 F. Supp. 3d at 1092; Norman, 2016 WL 4007547, at *2; Horowitz, 613 F. Supp. 2d at 282 (“to survive preemption under the MDA a plaintiff must demonstrate a cognizable link between the defendant’s federal violations and plaintiff’s injury”). Plaintiff’s claims do not fall within this “narrow gap.” She raises four meritless theories of liability: (1) failure to train; (2) misrepresentation and breach of warranty; (3) defects in the manufacturing process; and (4) failure to warn. All of these theories fail to overcome preemption. A. Plaintiff’s Claims Based On An Alleged Failure To Train Physicians Are Expressly Preempted. Plaintiff brings claims based in part on an allegation that Bayer negligently failed to train physicians See Am. Compl. Counts 2 (negligence) and 3 (strict liability); id. ¶ 138 (Bayer “fail[ed] to properly train and educate physicians on the use of the Essure device”). This claim is preempted because Plaintiff fails to “allege . . . any facts that give rise to a recognizable theory as to how any departure from the [FDA-approved] training guidelines may have caused” her injuries. McLaughlin, 172 F. Supp. 3d at 817; see also Frere v. Medtronic, Inc., No. 15-2338, 2016 WL 1533524, at *10 (C.D. Cal. Apr. 6, 2016) (similar). Indeed, the Amended Complaint alleges no factual allegations regarding how Plaintiff’s own physician was trained, how that training violated FDA training requirements, or how the vague and overbroad alleged inadequacies in the training caused Plaintiff’s injuries-primarily a known and warned about allergic reaction to the nickel in the device. See, e.g., Am. Compl. ¶¶ 112-24. To the extent Plaintiff alleges that her physician negligently failed Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 16 of 32 Page ID #:189 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 9 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES to administer a nickel hypersensitivity skin test, see id. ¶ 122, Plaintiff alleges no facts linking her physician’s conduct to Bayer’s Essure training. Nor could she, as Essure’s FDA-required labeling unambiguously discloses the need for, and directs the placement physicians to perform, a skin test: Patients with suspected hypersensitivity to nickel should undergo a skin test to assess hypersensitivity prior to an Essure placement procedure. . . . The Essure system should not be used in any patient . . . with . . . [k]nown hypersensitivity to nickel confirmed by a skin test. RJN Ex. J (2008 IFU) at 2. As numerous courts have concluded in dismissing similarly meritless failure to train claims against Essure, “bald allegations of both negligence and causation” do not “set[] forth a plausible claim of negligent training.” McLaughlin, 172 F. Supp. 3d at 817 (quoting Iqbal, 556 U.S. at 678); see De La Paz, 159 F. Supp. 3d at 1096 (a failure to train claim “must also plausibly allege a causal link between any alleged negligence in training and [the plaintiff’s] injuries”); Norman, 2016 WL 4007547, at *5 (dismissing claim because “Plaintiff fails to allege any facts that could plausibly suggest that her injuries were the result of the alleged negligent training”); Noris, RJN Ex. C. at 25:16-17 (dismissing failure to train claim without leave to amend). This Court should do the same. B. Plaintiff’s Claims Based On Alleged Misrepresentations And Warranties Are Expressly Preempted. Plaintiff’s misrepresentation and warranty claims also fail. In Counts 2 and 4, Plaintiff asserts that Bayer made misrepresentations regarding Essure’s safety and efficacy that induced her to undergo the Essure procedure. But FDA approved language virtually identical to each alleged misrepresentation in Essure’s labeling: Alleged Misrepresentation FDA-Approved Labeling Statement • Essure is the “[o]nly FDA approved female sterilization procedure to have zero pregnancies in the clinical trials.” Am. Compl. ¶ 98a. • “In the Essure clinical studies, zero (0) pregnancies were reported in women who had the Essure inserts for up to 5 years.” See RJN Ex. G at 12 (2015 PIB); RJN Ex. J (2008 IFU) at 3 (similar) (“no (zero) pregnancies reported”). Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 17 of 32 Page ID #:190 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 10 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES Alleged Misrepresentation FDA-Approved Labeling Statement • Essure procedure is “[s]urgery- free.” Am. Compl. ¶ 98b. • Essure “eliminates the risks, discomfort, and recovery time associated with surgical procedures.” Am. Compl. ¶ 98f. • Essure is “Non-Surgical.” See RJN Ex. G at 5 (2015 PIB) • Essure “does not involve cutting or puncturing the body, and does not cut, crush, or burn the fallopian tubes.” RJN Ex. I (2008 PIB) at 6. • Essure procedure is “[w]orry free” and a “simple procedure performed in your doctor’s office that takes less than 10 minutes.” Am. Compl. ¶ 98c. • “Essure may be right for you if . . . You would like to stop worrying about getting pregnant” and “prefer a method or procedure that . . . [i]s simple and does not take a lot of time.” RJN Ex. P (2012 PIB) at 4; RJN Ex. G (2015 PIB) at 4. • “Essure procedure can be performed in the comfort and convenience of a doctor’s office.” See RJN Ex. I (2008 PIB) at 6. • “The entire process usually takes less than ten minutes.” See RJN Ex. P (2012 PIB) at 9. • “Essure inserts stay secure, forming a long protective barrier against pregnancy.” Am. Compl. ¶ 98d. • Essure’s micro-inserts “remain visible outside your tubes, so your doctor can confirm that they’re properly in place.” Id. • “[Y]our body and the micro inserts work together to form a tissue barrier (like scar tissue) so that sperm cannot reach the egg.” RJN Ex. I (2008 PIB) at 4. • Essure results in “tissue in-growth into the device that anchors the device.” RJN Ex. O (2011 IFU) at 1. • During “Essure Micro-Insert Placement Procedure,” “[e]xpanded outer coils of the Essure micro-insert trailing into the uterus indicates ideal placement.” See RJN Ex. O (2011 IFU) at 5; RJN Ex. H (2013 IFU) at 8 (similar). • “Th[e] viewable portion of the micro- insert serves to verify placement . . . .” See RJN Ex. I (2008 PIB) at 10. Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 18 of 32 Page ID #:191 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 11 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES Alleged Misrepresentation FDA-Approved Labeling Statement • Essure “inserts are made from the same trusted, silicone free material used in heart stents.” Am. Compl. ¶ 98e. • “The micro inserts are made with materials that have been used in medical devices for many years.” RJN Ex. I (2008 PIB) at 4. • “These same materials have been used for many years in cardiac stents and other medical devices placed in other parts of the body.” See RJN Ex. P (2012 PIB) at 11. • Essure “is the most effective permanent birth control available- even more effective than tying your tubes or a vasectomy.” Am. Compl. ¶ 98g. • “The Essure procedure is 99.80% effective at preventing pregnancy, based on 4 years of clinical data.” RJN Ex. I (2008 PIB) at 6. • Comparing Essure with both tubal ligation and vasectomy procedures, and reporting a rate of failure for each that is higher than that of Essure. RJN Ex. J (2008 IFU) at 3 (same). Because these purported “misrepresentations” and “warranties” track the FDA- approved statements, Plaintiff’s claims based on alleged misrepresentations are expressly preempted. See 21 U.S.C. § 360k(a). Indeed, the federal courts in De La Paz, Norman, and Richardson dismissed highly similar claims for this reason. See Norman, 2016 WL 4007547, at *5 (dismissing misrepresentation and warranty claims because alleged misstatements were “so similar to the approved language as to be substantively the same.”); De La Paz, 159 F. Supp. 3d at 1097-98 (holding similar); Richardson, 2016 WL 4546369 (dismissing similar claims because alleged misstatements are subject to FDA’s active approval); see also Pinsonneault v. St. Jude Med., Inc., 953 F. Supp. 2d 1006, 1019 (D. Minn. 2013) (“to the extent that plaintiffs’ breach of express warranty claims are based on representations stated on an FDA- Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 19 of 32 Page ID #:192 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 12 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES approved label or on statements that were otherwise approved or mandated by the FDA, such claims are preempted”).3 C. Plaintiff’s Claims Based On An Alleged Defect In The Manufacturing Process Are Expressly And Impliedly Preempted. Plaintiff also brings claims based on the theory that there was a defect in the manufacturing process for Essure. See Am. Compl. Counts 2 (negligence) and 3 (strict liability); id. ¶ 137 (”The Essure device contained a manufacturing defect when it left Defendants’ possession ….”); id at ¶ 154 (same). As numerous courts have held in similar circumstances, however, federal law preempts these claims where (as here) the plaintiff fails to allege facts plausibly showing that a deviation from Essure’s FDA-approved manufacturing process resulted in a defect in her device that caused her injury. See De La Paz, 159 F. Supp. 3d at 1094-95; McLaughlin, 172 F. Supp. 3d at 836; Norman, 2016 WL 4007547, at *3; Richardson, 2016 WL 4546369, at *5. As an initial matter, Plaintiffs’ manufacturing claims are expressly preempted because they are not based on a failure to follow a “specific federal requirement in the PMA approval.” In re Medtronic, 623 F.3d at 1206. “In order to avoid preemption on a manufacturing defect claim, [a] plaintiff must allege that her device was not manufactured in conformance with the specification approved by the FDA.” Norman, 2016 WL 4007457, at *3. But here, every manufacturing “requirement” Plaintiffs identify is actually a generally applicable FDA Current Good Manufacturing Practice (“CGMP”). See, e.g., Compl. ¶¶ 137, 154 (alleging that the manufacturing process “did not conform to the CGMP design controls enumerated in 21 C.F.R. § 820.30.”). As the Eighth Circuit explained in In re Medtronic, however, CGMP requirements are 3 A fourth federal court decision involving Essure, McLaughlin, reached the same legal conclusion as De La Paz, Norman, and Richardson but reserved for another proceeding an evaluation of whether the alleged misrepresentations were “consistent with FDA-approved statements.” McLaughlin, 172 F. Supp. 3d at 827 n.21. Here, because the consistency between FDA-approved statements and Plaintiff’s alleged misrepresentations is apparent, this Court should reach this question now and find that Plaintiff’s claims are preempted, as Norman, De La Paz, and Richardson did. Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 20 of 32 Page ID #:193 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 13 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES merely an “umbrella quality system” providing “general objectives” for manufacturers. In re Medtronic, 623 F.3d at 1206. Accordingly, CGMPs do not create “specific federal requirement[s] in the PMA approval”-and thus “do not save . . . claims from preemption.” In re Medtronic, 623 F.3d at 1206; see also Frere, 2016 WL 1533524, at *7 (CGMPs “may be insufficient to establish a parallel claim that can avoid express preemption” where the CGMP provides only “open-ended standards, not concrete requirements.”); Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 588 (E.D.N.Y. 2009) (CGMPs are too “intentionally vague and open-ended” to save claims from preemption); Horowitz, 613 F. Supp. 2d at 284 (CGMPs “too generic” to save claims from preemption). In addition, as other courts have held in dismissing Essure claims based on similar allegations, the claims also are preempted and inadequately pled because Plaintiff fails to allege facts plausibly showing that any deviation from FDA requirements “resulted in a manufacturing defect that caused her injuries.” De La Paz, 159 F. Supp. 3d at 1094; see also, e.g., Cohen v. Guidant Corp., No. 05-8070, 2011 WL 637472, at *2 (C.D. Cal. Feb. 15, 2011) (claims preempted where plaintiff failed to “link[]” federal requirements “to a defect in his specific pacemaker that was caused by Defendants violating FDA regulations”). Plaintiff asserts that Bayer (or its predecessor) manufactured Essure at an unlicensed facility, Am. Compl. ¶¶ 65-66; used non-conforming material in the manufacturing of Essure, and failed to adequately document its use, id. ¶¶ 61, 72(f), 77. But, as other courts reviewing similar allegations have held, such allegations offer “no description of the ‘non-conforming material’ used in manufacturing the device,” De La Paz, 159 F. Supp. 3d at 1095, no “explanation for how Bayer’s alleged operation without a license led to any manufacturing defect,” id., no “plausible reason to think that her device came from [a] non-conforming batch, or that it suffered from any other manufacturing defect,” Norman, 2016 WL 4007457, at *3, and no “facts that would make it plausible that the complications she suffered . . . were due to any Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 21 of 32 Page ID #:194 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 14 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES defect in the device,” id. Indeed, it “is not even plausible” that many of the manufacturing deficiencies alleged by Plaintiff “could . . . cause a product abnormality.” McLaughlin, 2016 WL 1161578, at *23 (emphasis added); see also De La Paz, 159 F. Supp. 3d at 1094-95; Norman, 2016 WL 4007547, at *3 (similar); Richardson, 2016 WL 4546369, at *5. Accordingly, as in Norman, De La Paz, McLaughlin, and Richardson, Plaintiff’s claims fail. Plaintiff’s only attempt to link manufacturing deficiencies with her alleged injuries is the attenuated and conclusory claim that failure to “conform to the CMP design controls enumerated in 21 C.F.R. § 820.30,” Am. Compl. ¶¶ 137, 154, resulted in “ongoing and systematic failures related to the control of non-conforming materials” that somehow caused her device to become “unpassivated,” which in turn somehow caused the device to break. Id. ¶¶ 137, 147, 154. These vague and speculative allegations have no causal connection to one another and are insufficient to state a plausible claim. In support of her conclusory allegation of “ongoing and systematic” use of nonconforming materials, Plaintiff identifies only two specific instances of alleged deviations from CGMP requirements, see, e.g., Am. Compl. ¶¶ 57, 72(f), neither of which could have plausibly resulted in Plaintiff’s own device being defectively manufactured with nonconforming materials. First, Plaintiff alleges that Bayer’s predecessor Conceptus, back in 2003- seven years before Plaintiff’s own procedure-failed to adequately document the rejection of certain non-conforming “raw materials and sub-assemblies” during Essure’s manufacturing process. Id. ¶ 57; see RJN Ex. S (2003 FDA 483). But Plaintiff’s own allegations-as well as the FDA form itself to which she points- make clear that the non-conforming materials at issue were not actually used in any manufactured Essure device, much less a device that entered into the stream of commerce and was implanted into any patient. Rather, the non-conforming materials were “rejected,” and the CGMP violation was simply a failure to document the Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 22 of 32 Page ID #:195 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 15 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES rejection in a “Material Review Report,” used for tracking “trends in sources of product.” Am. Compl. ¶ 57; see RJN Ex. S (2003 FDA 483). The rejection of unsatisfactory raw materials, by its very nature, does not plausibly result in the use of non-conforming materials in a device. Plaintiff also fails to describe the “non-conforming” material, fails to explain how the non-conforming material could cause any Essure coils to become “unpassivated,” and fails to offer any plausible basis for concluding that the rejection of certain non-conforming material in 2003 in any way impacted her own device, which was placed over seven years later. Am. Compl. ¶ 112 (device placed in 2010). Accordingly, Plaintiff fails to state a non- preempted claim based on this alleged documentation violation. Second, Plaintiff alleges that Bayer’s predecessor Conceptus failed “to adequately document . . . an incident involving the erroneous use of uncertified material by Conceptus’[s] contract manufacturer in a validation protocol.” Am. Compl. ¶ 72(f); see RJN Ex. T (2011 FDA 483). But as Judge Alsup explained in De La Paz, the FDA report at issue (as well as Plaintiff’s own allegations) at best “indicated that the manufacturer had erred by failing to adequately document the disposition of that material, not by using the material itself” in any actual Essure device. De La Paz, 159 F. Supp. 3d at 1095 (emphasis added). Here, as in De La Paz, Plaintiff “provides no basis for concluding that the failure to document the disposition of non-conforming material in a validation protocol caused a manufacturing defect in any Essure device,” much less in her specific device. Id. And again, Plaintiff provides no explanation for how the “non-conforming material” at issue-even if it had been used in any device-could have caused the device to become “unpassivated.” See, e.g., RJN Ex. T (no FDA finding that the “non- conforming material” could lead devices to become “unpassivated”). Finally, Plaintiff claims that Bayer failed to timely inform FDA of its change in manufacturing site from San Carlos, California, to Mountain View, California, and Chihuahua, Mexico, to “avoid[] inspection of the facility and its manufacturing Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 23 of 32 Page ID #:196 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 16 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES process for years”- apparently asking the Court to speculate that “a pattern of systematic manufacturing processes violations” occurred in the meantime. See, e.g., Am. Compl. ¶¶ 65-66, 71. But Plaintiff’s own allegations, as well as judicially noticeable regulatory documents, show that Bayer informed FDA of the manufacturing facility in Mexico in 2004, and FDA approved the facility. Id. ¶ 62; RJN Ex. M (PMA Supplement Approval). Further, Plaintiff’s assertion that Bayer “avoid[ed] inspection” of its manufacturing facilities is contradicted by her allegations that Bayer’s manufacturing facilities, in fact, were inspected by FDA regulatory authorities on multiple occasions, including in June 2003, September 2005, July 2008, December 2010, and May 2013. Am. Compl. ¶¶ 56, 63, 67, 71. Plaintiff’s requested inference that “a pattern of systematic manufacturing processes violations” occurred is therefore far too speculative to support her claims. See Parker, 514 F. 3d at 95 (factual allegations “must be enough to raise a right of relief above the speculative level”); Iqbal, 556 U.S. at 678 (factual allegations must “allow[] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged”) (emphasis added). Thus, this Court should follow Norman, De La Paz, McLaughlin and Richardson, and dismiss this claim as preempted. As those courts explained, a plaintiff “cannot state a claim based solely” on an alleged failure to follow various manufacturing regulations, “since any such claim would ‘exist solely by virtue of the [MDA],’” and is therefore impliedly preempted under Buckman. De La Paz, 159 F. Supp. 3d at 1094-95 (quoting Buckman, 531 U.S. at 353) (emphasis added). And Plaintiff fails to allege facts plausibly linking any alleged deviations from federal manufacturing requirements for Essure to a defect in her specific device that caused her particular injuries. See McLaughlin, 2016 WL 1161578, at *23; De La Paz, 159 F. Supp. 3d at 1095; Richardson, 2016 WL 4546369, at *5; Norman, 2016 WL 4007547, at *3 (similar). Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 24 of 32 Page ID #:197 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 17 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES D. Plaintiff’s Claims Based On An Alleged Failure To Warn Are Expressly And Impliedly Preempted. Finally, Plaintiff’s failure to warn claims-whether predicated on an alleged failure to warn patients or doctors directly or on an alleged failure to submit adverse event reports to FDA-also are preempted by federal law. First, Plaintiff poses a frontal attach on the FDA-approved Essure labeling, alleging that it failed to adequately warn patients and the medical community of the product’s risks. See, e.g., Am. Compl. ¶¶ 127 (alleging that Bayer failed to adequately “warn[] the public, including Ms. Harrison and her implanting physician” about the risks and danger of Essure”), 129 (alleging that Bayer failed to “inform physicians and patients about known and knowable complications through their product labeling”). Plaintiff, however, does not allege that the warnings Bayer provided in any way deviated from the FDA-approved language. Federal courts have routinely held that state-law claims that would require additional warnings or information beyond what FDA required are “precisely the type[s] of state requirements that [are] ‘different from or in addition to’ the federal requirement[s] and therefore are preempted.” In re Medtronic, 623 F.3d at 1205; accord Riegel, 552 U.S. at 330; Perez, 711 F.3d at 1118; Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919, 929 (5th Cir. 2006); King v. Collagen Corp., 983 F.2d 1130, 1136 (1st Cir. 1993) (claims challenging the adequacy of “FDA-regulated packaging and labeling” are preempted); Caplinger, 784 F.3d at 1345; Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301-02 (11th Cir. 2011). For this reason, highly similar claims regarding Essure have been dismissed as preempted. See Norman, 2016 WL 4007547, at *3 (“it is clear that plaintiff cannot bring a claim because defendants failed to warn plaintiff personally”); Lance v. Bayer Essure Inc., RG16809860, at 16 (RJN Ex. R) (“[T]o the extent Plaintiffs’ state law claims for failure to warn are based on the theory that Defendants should have given warnings directly to doctors and patients different from those approved by the FDA, they are expressly preempted.”). Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 25 of 32 Page ID #:198 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 18 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES To the extent Plaintiff suggests that Bayer could have unilaterally provided additional warnings through the “Changes Being Effected” process under 21. C.F.R. § 814.39(d), see Am. Compl. ¶ 129, this allegation does not save her claims. Unlike the system governing prescription drugs, for pre-market approved medical devices such as Essure, “[b]ecause § 814.39 permits, but does not require, a manufacturer to provide interim supplemental warnings pending approval by the FDA, a common-law duty to provide such a warning imposes an additional obligation” and is expressly preempted. McMullen v. Medtronic, Inc., 421 F.3d 482, 489-90 (7th Cir. 2005) (emphasis added); 21 C.F.R. § 814.39(d); see also In re Medtronic, 623 F.3d at 1205 (“Where a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement . . . is preempted.”); Stengel v. Medtronic Inc., 704 F.3d 1224, 1234 (9th Cir. 2013) (Watford, J., concurring) (Because FDA regulations “permitted” but “did not require” supplemental post-sale warnings, “any attempt to predicate the Stengels’ claim on an alleged state law duty to warn doctors directly would have been expressly preempted”). Second, Plaintiff alleges that Bayer failed to “timely file MDRs [Medical Device Reports] and to report to the FDA complaints not addressed by the device’s labeling and/or complaints that were occurring with an unexpected increase in severity and frequency.” Am. Compl. ¶ 92; see also id. ¶ 128 (alleging failure to communicate “roughly 32,000 complaints that [Bayer] had internally received about Essure”); id. ¶ 167 (“Ms. Harrison would have never had Essure® implanted had she been aware that there had been 32,000 complaints regarding Essure®.”). Plaintiff claims that had Bayer “timely and adequately reported the adverse events to the FDA, it would have effectively warned physicians,” including Plaintiff’s physician, and that Plaintiff “would not have agreed to the Essure implant.” Id. ¶¶ 129, 131, 167. De La Paz and Norman dismissed this claim as well. See Norman, 2016 WL 4007547; De La Paz, 159 F. Supp. 3d at 1096-97. These claims are impliedly preempted under Buckman because “plaintiff[s] fail[] to plead facts that plausibly Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 26 of 32 Page ID #:199 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 19 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES connect defendants’ alleged reporting violations to [their] injuries.” Norman, 2016 WL 4007547; De La Paz, 159 F. Supp. 3d at 1096-97. Many of these complaints were lodged after Plaintiff’s procedure, and therefore could not have caused her injuries. Rosburg v. Minnesota Mining & Mfg. Co., 226 Cal. Rptr. 299, 305 (Ct. App. 1986). And, according to Plaintiff’s allegations, FDA now has all of the supposedly withheld information. Am. Compl. ¶ 78 (alleging that in a 2013 inspection, “part of the FDA’s review focused on 16,047 complaints Conceptus received on the Essure device”); ¶ 130 (alleging that “the medical community and the FDA became aware of the undisclosed adverse events” prior to the September 2015 FDA public hearing).4 Despite having reviewed and considered these allegedly withheld reports and additional medical literature, FDA has never withdrawn its approval of Essure. To the contrary, after reviewing the same allegations made here, FDA recently found “no conclusive evidence in the literature indicating any new or more widespread complications definitely associated with Essure,” RJN Ex. N (FDA Activities) at 5, and reaffirmed that “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control,” RJN Ex. D (FDA News Release). As Norman held, Plaintiff’s attempt to invoke FDA’s recent boxed warning and Patient Decision Checklist only further undermines her claims and confirms why they are preempted. 2016 WL 4007547, at *4. After holding a public hearing regarding “the safety and efficacy of Essure,” during which FDA considered the allegedly withheld events Plaintiff raises here, see Am. Compl. ¶ 106, FDA did not require Bayer to change its disclosures on the percentage of patients who may be injured, the 4 Plaintiff’s repeated attempt to highlight the number of complaints received by Bayer relative to the number of MDRs submitted, see, e.g., Compl. ¶ 78 (alleging FDA received 16,047 complaints), also ignores the fact that there is no obligation blindly to report all “complaints” to the agency. See 21 C.F.R. § 820.198(b) (“Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary.”); id. § 820.198(d) (providing additional procedures for “[a]ny complaint that represents an event which must be reported to FDA”). Plaintiff points to no FDA finding that the complaints-which FDA reviewed during its inspection-were “adverse events” that should have been reported to FDA earlier. Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 27 of 32 Page ID #:200 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 20 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES number of adverse events, or the rate of unintended pregnancies. Instead, FDA proposed (and later adopted) a “boxed warning” for all “devices of this type,” because the agency believes “that some women are not receiving or understanding information regarding the risks and benefits.” RJN Ex. Q (Final Guidance) at 5-6. As Norman held, this “new type of warning did not change any of the warnings’ substance,” 2016 WL 4007547, at *4. Rather, the same information was already in Essure’s labeling: Prior Essure Labeling Current Boxed Warning RJN, Ex. Q (2016 Guidance) • “To reduce the risk of uterine perforation, the procedure should be terminated if excessive force is required to achieve cervical dilation . . . .” RJN Ex. J (2008 IFU) at 2. • “Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic device cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such adverse event, a surgical procedure will be required.” (Guidance at 9). • “A small percentage (1.8%) of women in the clinical studies experienced tubal perforation related to Essure micro insert placement.” RJN Ex. I (2008 PIB) at 15. • “Potential adverse events” include “[p]erforation of internal bodily structures other than the uterus and fallopian tube.” RJN Ex. J (2008 IFU) at 2. • “A very small percentage of women in the Essure procedure clinical trials reported recurrent or persistent pelvic pain.” RJN Ex. J (2008 IFU) at 2. • “Patients who are allergic to nickel may have an allergic reaction to the inserts. Symptoms include rash, itching and hives.” RJN Ex. G (2015 PIB) at 8; see also RJN Ex. I (2008 PIB) at 4, 8. • “[I]f device removal is required for any reason, it will likely require surgery, including an abdominal incisions and general anesthesia, and possible hysterectomy.” RJN Ex. J (2008 IFU) at 2. Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 28 of 32 Page ID #:201 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 21 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES Thus, Plaintiff’s conclusory assertion that if Bayer had “timely and adequately reported the adverse events to the FDA,” either the agency would have issued new warnings or it would have resulted in additional studies sufficient to deter Plaintiff and her physician from obtaining Essure, is insufficient to allege causation. Am. Compl. ¶¶ 129-31; see De La Paz, 159 F. Supp. 3d at 1097 (“De La Paz has failed to plausibly show that her injuries would have been prevented if Bayer had properly reported the perforation events-a necessary element of her failure-to-warn-the-FDA claim”); see also Horowitz, 613 F. Supp. 2d at 282 (similar). As in Norman and De La Paz,5 this Court should dismiss the claim. II. PLAINTIFF FAILS TO STATE ANY VALID CLAIM UNDER CALIFORNIA LAW. A. Plaintiff Fails To Plead Causation Adequately. Plaintiff’s inability to allege causation for each of her claims also prevents her from clearing the federal pleading threshold under Rule 12. As discussed above, Plaintiff relies impermissibly on conclusory allegations that the alleged deficiencies in the training, representations, manufacturing process, and warnings “proximately” caused her injuries. See, e.g., Am. Compl. ¶¶ 117, 150, 160; see also supra 10, 11-12, 16-18. With no factual allegations supporting a causal link between alleged wrongdoing by Bayer and Plaintiff’s injuries, the Amended Complaint simply does not provide “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570 (emphasis added). Because causation is a required element of each theory Plaintiff raises, there is no basis to conclude that the right to recovery is 5 Likewise McLaughlin expressly recognized this critical element of causation, as did Stengel, 704 F.3d at 1233-34. See 172 F. Supp. 3d at 837 (causal chain is broken and “a supplier’s duty to warn is discharged” when the supplier provides warnings to third parties, i.e., doctors, “upon whom it can reasonably rely to communicate the information to the ultimate users of the product.”) (quotation omitted). Here, after receiving the information, FDA not only reaffirmed that Essure remains an appropriate permanent birth control option, but further chose not to alter the substance of the disclosures “to the ultimate users” regarding the risks of the device. Further, Bayer respectfully submits that because Stengel runs counter to the Supreme Court’s holding in Buckman, it was wrongly decided. See In re Medtronic, Inc., 623 F.3d at 1205. Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 29 of 32 Page ID #:202 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 22 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES plausible. Plaintiff’s reliance on mere “labels and conclusions, and a formulaic recitation of the elements of a cause of action,” id. at 545, makes her Amended Complaint precisely the sort of “unadorned, the-defendant-unlawfully-harmed-me accusation” that the Supreme Court has held insufficient, Iqbal, 556 U.S. at 678. Her claims should be dismissed for this additional reason, as other federal courts have done in similar circumstances. See, e.g., McLaughlin, 172 F. Supp. 3d at 817, 836, 23; De La Paz, 159 F. Supp. 3d at 1095; Norman, 2016 WL 4007547, at *6. In addition, Plaintiff’s conclusory allegations of causation are particularly implausible with regard to her allegations that she was harmed by an allergic reaction to the nickel contained in her device. Am. Compl. ¶¶ 105-06. Nickel is part of the FDA-approved design of Essure, and the FDA-approved labeling at the time of Plaintiff’s procedure specifically warned that it should not be used by patients with nickel allergies. See 4-5, supra. Plaintiff thus cannot plausibly allege that her alleged “nickel poisoning” or other allergy-related injuries were caused by any deviations from FDA requirements, or any failure to warn her physician with respect to some other potential side effect. Compl. ¶ 114; Tapia v. Davol, Inc., 116 F. Supp. 3d 1149, 1157 (S.D. Cal. 2015) (“California applies the ‘learned intermediary’ doctrine which provides that the duty to warn in the case of medical devices runs to the physician, not the patient,” and “[a] manufacturer fulfills its duty to warn if it provides adequate warnings to the physician”); Dobbs’ Law of Torts § 468 (2d ed.). B. Plaintiff Fails To Plead Her Fraud-Based Claims With Particularity. Plaintiff also fails to plead her fraud and negligent misrepresentation claims (contained in Counts 2 and 4) with the specificity required by Federal Rule of Civil Procedure 9(b). Under this heightened pleading standard, Plaintiff “must state with particularity the circumstances constituting fraud,” Fed. R. Civ. P. 9(b), including each element of the fraud claim and the “who, what, when, where, and how of the misconduct charged.” Kearns, 567 F.3d at 1124, 1126-27; see UMG Recordings, Inc. v. Global Eagle Entm’t, Inc., 117 F. Supp. 3d 1092, 1106 (C.D. Cal. 2015) (“Claims Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 30 of 32 Page ID #:203 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 23 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES for fraud and negligent misrepresentation must meet the heightened pleading requirements of Rule 9(b)” (internal quotes omitted)); U.S. Concord, Inc. v. Harris Graphics Corp., 757 F. Supp. 1053, 1058 (N.D. Cal. 1991) (dismissing fraud and negligent misrepresentation claims for failing to satisfy Rule 9(b)’s particularity requirements). Like the failed claims in De La Paz, Plaintiff does not allege which of the supposed misrepresentations she reviewed, when she reviewed them, how she relied on those alleged misrepresentations, or how they caused her alleged injuries. See De La Paz, 159 F. Supp. 3d at 1098-99. Instead, Plaintiff alleges only that she relied on “selling points in the Defendants’ brochure,” and that her “physician discussed all the selling features of the device listed in company advertisements and commercials,” without factual support or specificity. Am. Compl. ¶¶ 111-12. Plaintiff does not allege what “advertisements and commercials” she or her physician reviewed, or specify what information her doctor conveyed to her about the device.6 These vague allegations are insufficient to meet the requirement of particularity. See McLaughlin, 172 F. Supp. 3d at 829 (plaintiffs failed to plead fraud-based claims with particularity); Herrington v. Johnson & Johnson Consumer Cos., No. 09-cv-1597, 2010 WL 3448531, at *7 (N.D. Cal. Sept. 1, 2010) (dismissing fraud-based claims where plaintiffs “do not plead the circumstances in which they were exposed to these statements,” and “do not plead upon which of these representations they relied”). 6 Plaintiff alleges only that her physician told her that the Essure procedure “is just as effective as the standard methods without the need for surgery and with no additional risk.” Compl. ¶ 111. As explained above, FDA specifically approved statements that the Essure procedure is at least as effective as other methods of contraception, and that it does not require surgery. See 10-11, supra. And Plaintiff’s general allegation that her physician told her that the procedure had “no additional risk” does not satisfy Rule 9(b) because she does not specifically allege the content of this supposed representation, and it is not the same as any supposed representation made by Bayer concerning the device’s risk set forth elsewhere in her Complaint. As explained above, those representations are also consistent with the device’s labeling. See 9-11, supra. Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 31 of 32 Page ID #:204 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 24 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES CONCLUSION For these reasons, the Court should dismiss Plaintiff’s claims pursuant to Fed. R. Civ. P 8, 9(b), and 12(b)(6). Dated: December 8, 2016 SIDLEY AUSTIN LLP By: /s/ Alycia A. Degen Alycia A. Degen Bradley J. Dugan SIDLEY AUSTIN LLP 555 West Fifth Street Los Angeles, CA 90013 (213) 896-6682 (213) 896-6600 (fax) adegen@sidley.com bdugan@sidley.com Rebecca K. Wood (Pro Hac Vice to be filed) Jonathan F. Cohn (Pro Hac Vice to be filed) SIDLEY AUSTIN LLP 1501 K Street, N.W. Washington, DC 20005 Telephone: (202) 736-8000 Facsimile: (202) 736-8711 rwood@sidley.com jfcohn@sidley.com Maja C. Eaton (Pro Hac Vice to be filed) meaton@sidley.com SIDLEY AUSTIN LLP One South Dearborn Chicago, IL 60603 Telephone: (312) 853-7000 Facsimile: (312) 853-7036 Attorneys for Defendants Bayer Essure Inc. Bayer Corporation, Bayer HealthCare LLC, and Bayer HealthCare Pharmaceuticals Inc. Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 32 of 32 Page ID #:205 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 [PROPOSED] ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA DENISE HARRISON, Plaintiff, v. BAYER CORP., BAYER HEALTHCARE LLC, BAYER ESSURE INC.; BAYER HEALTHCARE PHARMACEUTICALS, INC.; and DOES 1-10, inclusive, Defendants. Case No. 16-cv-01958-MWF (MRWx) [PROPOSED] ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS] Date: February 13, 2017 Time: 10:00 a.m. Location: Courtroom 9C Judge: Hon. Michael W. Fitzgerald Case 8:16-cv-01958-MWF-MRW Document 18-1 Filed 12/08/16 Page 1 of 2 Page ID #:206 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 [PROPOSED] ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS [PROPOSED] ORDER Defendants Bayer Corporation, Bayer Healthcare LLC, Bayer Essure, Inc. and Bayer HealthCare Pharmaceuticals, Inc.’s (collectively, “Bayer”) Motion to Dismiss Plaintiff’s Complaint (the “Motion”), pursuant to Fed. R. Civ. P. Rules 8, 9(b), and 12(b)(6), came on for hearing before this Court. After consideration of the parties’ briefing, including Bayer’s Request for Judicial Notice, and arguments of counsel, the Court concludes Plaintiff’s claims are preempted by federal law and fail to satisfy the applicable federal pleading standards. Accordingly, Bayer’s Motion is GRANTED. Plaintiff’s Complaint is hereby dismissed with prejudice. IT IS SO ORDERED. Dated: __________, 2017 ________________________________ HON. MICHAEL W. FITZGERALD Case 8:16-cv-01958-MWF-MRW Document 18-1 Filed 12/08/16 Page 2 of 2 Page ID #:207