Jacqueline Alexander et al v. Bayer Corporation et al

NOTICE OF MOTION AND MOTION to Dismiss Case /Plaintiffs' Complaints; Memorandum of Points and Authorities in Support Thereof

C.D. Cal.October 4, 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 JACQUELINE ALEXANDER, et al., Plaintiffs, v. BAYER CORP., BAYER HEALTHCARE LLC, BAYER ESSURE INC.; BAYER HEALTHCARE PHARMACEUTICALS, INC.; and DOES 1 -10, inclusive, Defendants. Case No. 2:16-cv-06822-MWF-MRW DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ COMPLAINTS; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF [Filed concurrently with Request for Judicial Notice; [Proposed] Order] Date: November 21, 2016 Time: 10:00 a.m. Location: Courtroom 1600 Judge: Hon. Michael Fitzgerald Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 1 of 36 Page ID #:2005 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 November 21, 2016 at 10:00 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 Plaintiffs’ Complaints, pursuant to Federal Rules of Civil Procedure 8, 9(b), and 12(b)(6), on the grounds that Plaintiffs’ claims are preempted by federal law and fail to satisfy federal pleading standards. In addition, the claims of the following plaintiffs are barred by the applicable statute of limitations: Tracey Godfrey, Tara Erickson, Shirley McCalebb, Nicole Harrison, Amanda Cummings, Amanda Worsham, Jamie Bell, Jennifer Lindsey, Sarah Stockgt, Tanya Lee, Aretha Washington, Megan and Andrew Woolwine, Tina Matney, Holli McAlpin, and Kea Taylor. 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. Counsel for Bayer provided Plaintiffs’ counsel with a written summary of the grounds for Bayer’s motion by email on September 19, 2016. The parties discussed Bayer’s intended motion by phone on September 23, 2016. During that conference, counsel for Plaintiffs advised that they would consider amending with respect to certain of Bayer’s arguments but not others and would let Bayer know by September 30 whether and when they would amend. On October 2, 2016, Plaintiffs’ counsel advised that Plaintiffs intended to amend, but did not provide a date certain by which they would file the amendment. On October 4, 2016, following inquiry from Bayer’s counsel, Plaintiffs’ counsel did not provide a date certain for their amendment and Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 2 of 36 Page ID #:2006 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 instead advised that Plaintiffs “will file by the end of the month” and will provide “a more definite date in a week or so.” Under the circumstances, Bayer is proceeding to file its motion to dismiss, which will permit Plaintiffs to see Bayer’s arguments in full prior to any amendment. Plaintiffs will then have the opportunity to amend, if they so choose, within the time permitted under the federal rules and with the guidance of Bayer’s full motion. Dated: October 4, 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 Jonathan F. Cohn (Pro Hac Vice to be filed) Rebecca K. Wood (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 jfcohn@sidley.com rwood@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 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 3 of 36 Page ID #:2007 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 PLAINTIFFS’ CLAIMS. ....................... 6 A. Plaintiffs’ Claims Based On An Alleged Manufacturing Defect Are Expressly And Impliedly Preempted. .......................... 8 B. Plaintiffs’ Claims Based On An Alleged Failure To Train Physicians Are Expressly Preempted. .......................................... 10 C. Plaintiffs’ Claims Based On Alleged Misrepresentations And Warranties Are Expressly Preempted. .................................. 11 D. Plaintiffs’ Claims Based On An Alleged Failure To Warn Are Expressly And Impliedly Preempted. .................................... 15 E. Plaintiffs’ Loss of Consortium Claims Are Also Preempted. .................................................................................... 19 II. PLAINTIFFS FAIL TO PLEAD THEIR FRAUD-BASED CLAIMS WITH PARTICULARITY. .................................................... 19 III. CERTAIN PLAINTIFFS’ CLAIMS ARE ALSO TIME- BARRED. ................................................................................................ 20 CONCLUSION ............................................................................................................ 25 Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 4 of 36 Page ID #:2008 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 Artiglio v. Corning, Inc., 18 Cal. 4th 604 (1998) ............................................................................................. 11 Aryeh v. Canon Bus. Solutions, Inc., 55 Cal. 4th 1185 (2013) ..................................................................................... 21, 22 Ashcroft v. Iqbal, 556 U.S. 662 (2009)............................................................................................. 6, 19 Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007)............................................................................................. 6, 19 Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001)........................................................................................... 3, 4, 7 Cal. Pub. Empls. Ret. Sys. v. Moody’s Investors Serv., Inc., 226 Cal. App. 4th 643 (2014) .................................................................................. 20 Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015) ........................................................................... 4, 15 Chione v. Medtronic, Inc. No. 14-cv-01043, 2015 WL 2151889 (S.D. Cal. May 7, 2015) .............................. 21 Clemens v. DiamlerChrysler Corp., 534 F.3d 1017 (9th Cir. 2008) ................................................................................. 22 Cohen v. Guidant Corp., No. 05-8070, 2011 WL 637472 (C.D. Cal. Feb. 15, 2011) ....................................... 9 Daimler AG v. Bauman, 134 S. Ct. 746 (2014) ................................................................................................. 2 Darringer v. Intuitive Surgical, Inc., 2015 WL 4623935 (N.D. Cal. Aug. 3, 2015) .......................................................... 23 Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 5 of 36 Page ID #:2009 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 De La Paz v. Bayer Healthcare LLC, 159 F. Supp. 3d 1085 (N.D. Cal. 2016) ............................................................ passim Deutsch v. Turner Corp., 324 F.3d 692 (9th Cir. 2003) ................................................................................... 21 Eidson v. Medtronic, Inc., 40 F. Supp. 3d 1202 (N.D. Cal. 2014) ..................................................................... 19 Erickson v. Boston Sci. Corp., 846 F. Supp. 2d 1085 (C.D. Cal. 2011) ................................................................... 23 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) ..................................... 10 Goldrich v. Natural Y Surgical Specialties, Inc., 25 Cal. App. 4th 772 (Ct. App. 1994) ..................................................................... 24 Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919 (5th Cir. 2006) ................................................................................... 15 Herrington v. Johnson & Johnson Consumer Cos., No. 09-cv-1597, 2010 WL 3448531 (N.D. Cal. Sept. 1, 2010) .............................. 20 Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y. 2009) ............................................................. 7, 8, 19 Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal. 2013) ..................................................................... 7 Kearns v. Ford Motor Co., 567 F.3d 1120 (9th Cir. 2009) ............................................................................. 6, 20 King v. Collagen Corp., 983 F.2d 1130 (1st Cir. 1993) .................................................................................. 15 Lance v. Bayer Essure Inc., RG16809860 (Cal. Super. Aug. 1, 2016) ............................................................ 1, 15 Manderville v. PCG&S Grp., Inc., 146 Cal. App. 4th 1486 (2007) ................................................................................ 20 Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 6 of 36 Page ID #:2010 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 Marino v. Countrywide Fin. Corp., 602 F. App’x 403 (9th Cir. 2015) ............................................................................ 25 McConologue v. Smith & Nephew, Inc., 8 F. Supp. 3d 93 (D. Conn. 2014).............................................................................. 7 McKelvey v. Boeing N. Am. Inc., 74 Cal. App. 4th 151 (Ct. App. 1999), superseded by statute on other grounds as stated in Grisham v. Philip Morris, 40 Cal. 4th 623 (2007) ................ 22 McLaughlin v. Bayer Corp., ---F. Supp. 3d.---, 2016 WL 1161578 (E.D. Pa. Mar. 22, 2016) ...................... passim McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 2005) ................................................................................... 15 Medali v. Bayer HealthCare LLC, No. RG15771555 (Cal. Super Ct. Feb. 16, 2016) ..................................................... 1 Medinger v. Bayer HealthCare Pham. Inc., __F. App’x__, 2016 WL 3582800 (2d Cir. July 1, 2016) ....................................... 21 In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) ........................................................................... 15, 16 Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)................................................................................................... 4 In re Mirena IUD Prods. Liab. Litig., No. 7:14-cv-05229, 2015 WL 144214 (S.D.N.Y. Jan. 9, 2015), aff’d sub nom. Medinger v. Bayer Healthcare Pharm. Inc., __ F. App’x __, 2016 WL 3582800 (2d Cir. July 1, 2016) ............................................................... 23 Norgart v. Upjohn Co., 21 Cal. 4th 383 (1999) ....................................................................................... 22, 25 Noris v. Bayer Essure, Inc., No. BC589882 (Cal. Super. Ct. April 26, 2016) ....................................................... 1 Norman v. Bayer Corp., No. 3:16-cv-00253 (JAM), 2016 WL 4007547 (D. Conn. July 26, 2016) ................................................................................................................. passim Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 7 of 36 Page ID #:2011 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 Perez v. Nidek Co., Ltd., 711 F.3d 1109 (9th Cir. 2013) ............................................................................. 8, 15 Pinsonneault v. St. Jude Med., Inc., 953 F. Supp. 2d 1006 (D. Minn. 2013) ................................................................... 14 Platt Elec. Supply, Inc. v. EOFF Elec., Inc., 522 F.3d 1049 (9th Cir. 2008) ................................................................................. 25 Plumlee v. Pfizer, Inc., No. 13-CV-414-LHK, 2014 WL 4275519 (N.D. Cal. Aug. 29, 2014) ................... 24 Ranza v. Nike, Inc., 793 F.3d 1059 (9th Cir. 2015) ................................................................................... 2 Richardson v. Bayer HealthCare Pharms. Inc., No. 4:15-cv-00443, 2016 WL 4546369 (D. Idaho Aug. 30, 2016) ............. 1, 6, 8, 14 Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)....................................................................................... 2, 3, 4, 7 Rita M. v. Roman Catholic Archbishop, 187 Cal. App. 3d 1453 (1986) ................................................................................. 22 Rivas v. Safety-Kleen Corp., 98 Cal. App. 4th 218 (Ct. App. 2002) ............................................................... 21, 22 Scott v. C.R. Bard, Inc., 231 Cal. App. 4th 763 (5th Dist. 2014) ................................................................... 11 Smith v. St. Jude Med., Inc., 217 Cal. App. 4th 313 (1st Dist. 2013) .................................................................... 11 Sprewell v. Golden State Warriors, 266 F.3d 979 (9th Cir 2001) ...................................................................................... 6 Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) ........................................................................... 16, 19 Theranos, Inc. v. Fuisz Pharma LLC, 876 F. Supp. 2d 1123 (N.D. Cal. 2012) ................................................................... 21 U.S. Concord, Inc. v. Harris Graphics Corp., 757 F. Supp. 1053 (N.D. Cal. 1991) ........................................................................ 20 Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 8 of 36 Page ID #:2012 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 vi NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES UMG Recordings, Inc. v. Global Eagle Entm’t, Inc., 117 F. Supp. 3d 1092 (C.D. Cal. 2015) ................................................................... 20 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) ............................................................................... 15 Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006) .................................................................................... 2, 3 Statutes and Regulations 21 U.S.C. § 332 ............................................................................................................... 4 21 U.S.C. § 333 ............................................................................................................... 4 21 U.S.C. § 334 ............................................................................................................... 4 21 U.S.C. § 337(a) .......................................................................................................... 4 21 U.S.C. § 360c(a)(1)(C)(i)-(ii) .................................................................................... 3 21 U.S.C. § 360e(c)(1)(H) .............................................................................................. 4 21 U.S.C. § 360e(d)(6)(A)(i) .......................................................................................... 3 21 U.S.C. § 360k(a) .............................................................................................. 2, 8, 14 21 U.S.C. § 360k(a)(1) .................................................................................................... 7 21 C.F.R. § 814.39(b) ................................................................................................... 15 21 C.F.R. § 814.39(d) ................................................................................................... 15 21 C.F.R. § 814.44(c) ..................................................................................................... 4 21 C.F.R. § 820.198(b) ................................................................................................. 17 21 C.F.R. § 820.198(d) ................................................................................................. 17 Rules Fed. R. Civ. P 8 ............................................................................................................. 25 Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 9 of 36 Page ID #:2013 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 vii NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES Fed. R. Civ. P. 9(b) ....................................................................................... 6, 19, 20, 25 Fed. R. Civ. P. 12(b)(6) ............................................................................................ 6, 25 Cal. Code Civ. Proc. § 335.1 ........................................................................................ 21 Legislative History H.R. Rep. No. 94-853 (1976) ......................................................................................... 2 Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 10 of 36 Page ID #:2014 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 complaints are meritless, and other courts have rejected virtually identical claims, which are preempted by federal law and do not meet federal pleading standards. See, e.g., Norman v. Bayer Corp., No. 3:16-cv-00253 (JAM), 2016 WL 4007547 (D. Conn. July 26, 2016) (dismissing all claims with prejudice); De La Paz v. Bayer Healthcare LLC, 159 F. Supp. 3d 1085 (N.D. Cal. 2016) (dismissing all claims, with leave to amend some); 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); McLaughlin v. Bayer Corp., No. 14-7315, ---F. Supp. 3d.---, 2016 WL 1161578, at *25 (E.D. Pa. Mar. 22, 2016) (dismissing 10 of 12 claims, with leave to amend some). Plaintiffs have fared no better in state courts. See Williams v. Bayer Corp., No. 15BA-CV02526 (Mo. Cir. Ct. July 18, 2016) (dismissing all claims 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) (order attached as Exhibit B to RJN); Noris v. Bayer Essure, Inc., No. BC589882, (Cal. Super. Ct. April 26, 2016) (same) (docket and transcript excerpts attached as Exhibit C to RJN); Lance v. Bayer Essure Inc., RG16809860 (Cal. Super. Aug. 1, 2016) (order attached as Exhibit R to RJN).1 Courts have had no trouble dismissing the claims at issue because, at bottom, Plaintiffs are 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 1 This action consists of seven state court actions that were consolidated “for all proceedings and all purposes” by the state court, and therefore removable to this Court under the mass action provision of the Class Action Fairness Act. See Dkt. 1, Notice of Removal ¶¶ 1-9. Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 11 of 36 Page ID #:2015 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 confirmed that “Essure 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 complaints because each claim is preempted or otherwise fails.2 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 2 Personal jurisdiction is lacking over two defendants, Bayer Corporation and Bayer HealthCare Pharmaceuticals, Inc., as to the claims of the 131 Plaintiffs who are not citizens of California. These defendants are not and have never been “at home” in this forum, Daimler AG v. Bauman, 134 S. Ct. 746, 751 (2014), nor did the non-California Plaintiffs suffer any alleged Essure-related injuries in California, Ranza v. Nike, Inc., 793 F.3d 1059, 1068-69 (9th Cir. 2015) (specific jurisdiction is “‘specific’ to the case before the court” because it focuses on whether the defendant’s “contacts with [the forum state] give rise to or relate to [the plaintiff’s] cause of action”). Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 12 of 36 Page ID #: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 3 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES 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). 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 Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 13 of 36 Page ID #:2017 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 4 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES 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 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). After it first approved 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). Instead, it has granted numerous supplemental approvals, including as recently as May 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 Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 14 of 36 Page ID #:2018 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 5 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES 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 fully disclosed on the label. Among other risks, Essure’s labeling states that some women experience “chronic pelvic pain” or “device related perforations” after placement. RJN Ex. H (2013 IFU) at 2; see also RJN Ex. G (2015 PIB) at 12 (noting risk of bleeding); RJN Ex. I (2008 PIB) at 15; RJN Ex. J (2008 IFU) at 2; RJN Ex. K (2002 PIB) at 14-17. The label further discloses that “if device removal is indicated, this will require surgery.” RJN Ex. H (2013 IFU) at 2; see also 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. Plaintiffs’ Procedures Plaintiffs are 164 unrelated women (and 23 spouses) from 39 different states. Each Plaintiff alleges that she had an Essure device placed between 2004 and 2015, and that she then suffered a range of side effects, including pelvic, back, and/or abdominal pain, abnormal menstrual bleeding, headaches, and skin rashes. See, e.g., Alexander Compl. ¶¶ 136, 149, 160, 169, 179.3 Certain Plaintiffs further allege that they subsequently underwent a hysterectomy (removal of uterus) or a salpingectomy (removal of fallopian tubes) to treat the alleged side effects, while other Plaintiffs 3 The allegations in the seven underlying complaints generally track one another. Thus, for ease of reference, Bayer cites to the Alexander Complaint where its allegations are representative of the other complaints. Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 15 of 36 Page ID #:2019 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 allege that they are still seeking treatment. See, e.g., Alexander Compl. ¶¶ 171, 194, 242, 262-63, 218, 231, 284, 295. Plaintiffs filed the seven underlying actions in state court, and following the actions’ consolidation for “all purposes,” Bayer removed the actions to this Court under the mass action provision of the Class Action Fairness Act. Each complaint makes identical or substantially similar allegations, and asserts the following claims against Bayer: (1) negligent failure to warn; (2) strict products liability - inadequate warnings; (3) negligence/negligence per se; (4) breach of express warranty; (5) negligent misrepresentation; (6) fraud; and, where applicable, (7) loss of consortium. See, e.g., Alexander Compl. ¶¶ 431-52. 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). Fraud-based claims must be pled with particularity under Federal Rule of Civil Procedure 9(b). Kearns v. Ford Motor Co., 567 F.3d 1120, 1125 (9th Cir. 2009). ARGUMENT I. FEDERAL LAW PREEMPTS PLAINTIFFS’ CLAIMS. As other federal courts have held in dismissing similar complaints involving Essure, Plaintiffs’ claims are preempted and fail as a matter of law. See Richardson, Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 16 of 36 Page ID #:2020 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 2016 WL 4546369; Norman, 2016 WL 4007547; De La Paz, 159 F. Supp. 3d 1085; see also McLaughlin, 2016 WL 1161578 (dismissing 10 of 12 claims).4 Federal law expressly preempts any state tort claim against medical devices 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; Norman, 2016 WL 4007547, at *2; De La Paz, 159 F. Supp. 3d at 1091. Claims against Essure are expressly preempted unless the plaintiff 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); see also Noris, No. BC589882, Tr. at 25:20-25 (RJN Ex. B); 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. Plaintiffs cannot second-guess FDA or its decision on how to enforce those requirements. Riegel, 552 U.S. at 343; 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 4 These decisions analyze the issues under the rubric of both preemption and federal pleading standards. See, e.g., McLaughlin, 2016 WL 1161578, at *23; Norman, 2016 WL 4007547, at *5. 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 a federal violation caused the particular plaintiff’s injuries, for instance, results in both a failure to state a claim under federal pleading standards and implied preemption. Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 282 (E.D.N.Y. 2009). While this brief primarily discusses the complaint’s deficiencies as a matter of preemption, the claims are also inadequately pled for many of the same reasons. See, e.g., infra at 9-11, 16-18. Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 17 of 36 Page ID #:2021 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 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).” 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, each Plaintiff must show (1) that Bayer violated some federal requirement; (2) that this federal violation also violates an independent and “parallel” state law requirement; and (3) that the federal violation caused the Plaintiff’s individual injuries. Id; see also Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 282 (E.D.N.Y. 2009) (“to survive preemption under the MDA a plaintiff must demonstrate a cognizable link between the defendant’s federal violations and plaintiff’s injury”); Norman, 2016 WL 4007547, at *2. Plaintiffs’ claims do not fall within this “narrow gap.” They raise four meritless theories of liability: (1) there are defects in Essure’s manufacturing process; (2) Bayer failed to train physicians adequately; (3) Bayer misrepresented Essure’s safety and effectiveness; and (4) Bayer failed adequately to warn of Essure’s risks. All of these theories fail to overcome preemption. A. Plaintiffs’ Claims Based On An Alleged Manufacturing Defect Are Expressly And Impliedly Preempted. Plaintiffs bring negligence/negligence per se claims based on the theory that their Essure devices were defectively manufactured. See, e.g., Alexander Compl. ¶ 479 (alleging that Bayer “negligently failed to manufacture Essure consistent with FDA specifications”). As numerous courts have held, federal law preempts these claims, because Plaintiffs fail to allege facts plausibly showing that a deviation from Essure’s FDA-approved manufacturing process resulted in a defect in their devices that caused each of their alleged injuries. See De La Paz, 159 F. Supp. 3d 1085 at 1094-95; McLaughlin, 2016 WL 1161578, at *23; Norman, 2016 WL 4007547, at *3; Richardson, 2016 WL 4546369, at * 5. Plaintiffs assert that Bayer violated several FDA requirements, including that Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 18 of 36 Page ID #:2022 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 Bayer failed “to advise the FDA of the change in manufacturing site,” id. ¶ 97, manufactured Essure at an unlicensed facility, id. ¶ 480c; failed “to conduct regular risk analysis of its Essure device, including a Design Failure Analysis,” id. ¶ 476b, used non-conforming material in the manufacturing of Essure and failed to adequately document its use, id. ¶¶ 480a, e, f, and “fail[ed] to use pre-sterile and post-sterile cages.” id.¶ 480b; see also id. ¶¶ 480e-i (alleging various procedural deficiencies in Bayer’s quality system). But Plaintiffs fail to allege how these purported violations actually yielded a single defective device. Indeed, it “is not even plausible” that many of the manufacturing deficiencies alleged by Plaintiffs “could . . . cause a product abnormality.” McLaughlin, 2016 WL 1161578, at *23 (emphasis added); see also De La Paz, 159 F. Supp. 3d at 1095 (“De La Paz has provided 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.”). Plaintiffs also fail to plead facts plausibly showing that their own specific devices suffered from any manufacturing defect, and do not allege how any purported manufacturing violations could have caused their injuries. For this reason, De La Paz, McLaughlin, Norman, and Richardson each dismissed virtually identical claims. See De La Paz, 159 F. Supp. 3d at 1094-95; McLaughlin, 2016 WL 1161578, at *23 (dismissing because “the Complaint does not allege that Bayer’s alleged failure to properly document certain manufacturing issues actually resulted in the products having manufacturing defects . . . or that such defects . . . caused any of Plaintiffs’ alleged injuries”); Norman, 2016 WL 4007547, at *3 (similar); see also, Cohen v. Guidant Corp., No. 05-8070, 2011 WL 637472, at *2 (C.D. Cal. Feb. 15, 2011) (similar). As those courts explained, Plaintiffs “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). Plaintiffs also have Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 19 of 36 Page ID #:2023 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 not stated a parallel claim under state law because they fail to link any alleged deviations from federal requirements to any manufacturing defect that caused their injuries. See McLaughlin, 2016 WL 1161578, at *23. These courts have not permitted any Essure manufacturing defect claim to proceed. This Court should follow suit. B. Plaintiffs’ Claims Based On An Alleged Failure To Train Physicians Are Expressly Preempted. Plaintiffs assert their negligence and negligence per se claims based in part on the allegation that Bayer negligently trained physicians. Alexander Compl. ¶ 71a (“Defendants failed to adequately train the implanting physician[s]”); ¶ 485 (similar). This claim is preempted because Plaintiffs fail to “allege . . . any facts that give rise to a recognizable theory as to how any departure from the training guidelines may have caused [Plaintiff’s injuries].” McLaughlin, 2016 WL 1161578, at *7; see also Frere v. Medtronic, Inc., No. 15-2338, 2016 WL 1533524, at *10 (C.D. Cal. Apr. 6, 2016) (similar). Indeed, the complaints allege no plaintiff-specific facts, much less facts regarding how each Plaintiff’s physician was trained, how that training violated FDA requirements, or how the vague and overbroad alleged inadequacies in the training caused each Plaintiff’s respective injuries. See, e.g., Alexander Compl. ¶¶ 130-142, 485. As numerous courts have concluded regarding virtually identical claims against Essure, such “bald allegations of both negligence and causation” do not “set[] forth a plausible claim of negligent training.” McLaughlin, 2016 WL 1161578, at *7 (quoting Iqbal, 556 U.S. at 678); see De La Paz, 159 F. Supp. 3d at 1096; 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 (holding similar). This Court should do the same. Furthermore, Plaintiff’s training claim is expressly preempted to the extent it is based on Bayer’s alleged failure to train physicians on third-party hysteroscopic Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 20 of 36 Page ID #:2024 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 equipment, see Alexander Compl. ¶¶ 485-86, because “training in the basics of hysteroscopy” is not “part of the FDA-mandated training” for Essure. McLaughlin, 2016 WL 1161578, at *7 n.9. To the contrary, Essure’s labeling makes clear that the onus was on physicians to acquire those skills prior to beginning Bayer’s Essure training: Essure should “be used only by physicians who are knowledgeable hysteroscopists.” See RJN Ex. H at 1 (2013 IFU).5 Because the FDA-approved training requirements do not include training in hysteroscopy, the claim seeks to impose a state requirement “which is in addition to FDA’s own safety requirements and, therefore is expressly preempted.” McLaughlin, 2016 WL 1161578, at *7-8. C. Plaintiffs’ Claims Based On Alleged Misrepresentations And Warranties Are Expressly Preempted. Plaintiffs assert claims for fraud, negligence, negligent misrepresentation, and breach of express warranties based in whole or in part on the allegations that Bayer engaged in “false and misleading advertising of Essure.” Alexander Compl. ¶ 39; ¶ 194; ¶ 181. But FDA approved virtually identical language in Essure’s labeling: Alleged Misrepresentation by Bayer Labeling Statement Approved by the FDA • Essure is the “[o]nly FDA approved female sterilization procedure to have zero pregnancies in the • “In the Essure clinical studies, zero (0) pregnancies were reported in women who had the Essure inserts for up to 5 5 For this reason, this claim also fails under state law because Plaintiffs have not and cannot allege facts showing the existence of a duty by Bayer to train physicians on hysteroscopic equipment, which Plaintiffs admit “is not part of the Essure device.” Alexander Compl. ¶ 45. “[I]n general, there is no duty to take affirmative action to assist or protect another.” Scott v. C.R. Bard, Inc., 231 Cal. App. 4th 763, 775 (5th Dist. 2014). A duty to take affirmative acts-including a duty to train-can arise only where “the defendant undertook the tasks alleged to have been performed negligently.” Id. at 775. Here, Plaintiffs allege only that Bayer provided hysteroscopic equipment to physicians. Alexander Compl. ¶ 486. Merely providing medical equipment-without undertaking to train physicians in how to use that equipment-does not give rise to a duty to train. Smith v. St. Jude Med., Inc., 217 Cal. App. 4th 313 (1st Dist. 2013) (finding that manufacturer had no duty where manufacturer’s representative provided equipment and was present during surgery, but did not undertake to instruct physician); Artiglio v. Corning, Inc., 18 Cal. 4th 604, 613-14 (1998) (“negligent undertaking claim” requires that “the actor . . . undertook, gratuitously or for consideration, to render services to another”). Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 21 of 36 Page ID #:2025 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 Alleged Misrepresentation by Bayer Labeling Statement Approved by the FDA clinical trials.” Alexander Compl. ¶ 69a. years.” See RJN Ex. G at 12 (2015 PIB); RJN Ex. P (2012 PIB) at 12 (similar); RJN Ex. J (2008 IFU) at 3 (similar). • The Essure procedure is “[s]urgery- free.” Alexander Compl. ¶ 69b. • Essure “eliminates the risks, discomfort, and recovery time associated with surgical procedures.” Alexander Compl. ¶ 69f. • Essure is “Non-Surgical.” See RJN Ex. G at 5 (2015 PIB); RJN Ex. P (2012 PIB) at 5. • 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. • The Essure procedure is “[w]orry free” and a “simple procedure performed in your doctor’s office that takes less than 10 minutes.” Alexander Compl. ¶ 69c. • “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 at 4 (2015 PIB). • “the Essure procedure is usually performed in your doctor’s office.” See RJN Ex. P (2012 PIB) at 6; see also RJN Ex. I (2008 PIB) at 6 (similar). • “The entire process usually takes less than ten minutes.” See RJN Ex. P (2012 PIB) at 9. Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 22 of 36 Page ID #:2026 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 Alleged Misrepresentation by Bayer Labeling Statement Approved by the FDA • “The Essure inserts stay secure, forming a long protective barrier against pregnancy.” Alexander Compl. ¶ 69d. • Essure’s micro-inserts “remain visible outside your tubes, so your doctor can confirm that they’re properly in place.” Id. • “[Y]our body will form tissue around the Essure inserts. This will develop a natural barrier within the fallopian tubes.” RJN Ex. P (2012 PIB) at 6; see also RJN I (2008 PIB) at 4 (similar). • Essure results in “tissue in-growth into the device that anchors the device.” RJN Ex. O at 1 (2011 IFU) • 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 at 10 (2008 PIB). • Essure’s “inserts are made from the same trusted, silicone free material used in heart stents.” Alexander Compl. ¶ 69e. • “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; RJN Ex. G at 11 (2015 PIB); RJN I (2008 PIB) at 4 (similar). • Essure “is the most effective permanent birth control available- even more effective than tying your tubes or a vasectomy.” Alexander Compl. ¶ 69g. • “The Essure procedure is 99.83% effective based on five-year clinical study data.” RJN Ex. P (2012 PIB) at 5. • Comparing Essure with both tubal ligation and vasectomy procedures, and reporting a rate of failure for each that is higher than that of Essure. Id. at 15-16; see also RJN Ex. J (2008 IFU) at 3 (same); RJN Ex. H (2013 IFU) at 5- 6; RJN Ex. G at 15-19 (2015 PIB). Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 23 of 36 Page ID #:2027 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 Alleged Misrepresentation by Bayer Labeling Statement Approved by the FDA • “The PET fibers are what caused the tissue growth,” and Essure “works with your body to create a natural barrier against pregnancy. Alexander Compl. ¶ 69i. • “The effectiveness of the Essure micro- insert . . . is believed to be due to a combination of the space filling design of the device and a local, occlusive, benign tissue response to the PET fibers . . . . It is believed that the tissue in- growth into the device caused by the PET fibers results in both device retention and pregnancy prevention.” See RJN Ex. O (2011 IFU) at 1; see also RJN Ex. J (2008 IFU) at 4 (similar); RJN Ex. H (2013 IFU) at 1. Because these purported “misrepresentations” and “warranties” track FDA- approved statements, Plaintiffs’ claims for negligent and fraudulent misrepresentation and for breach of express warranty are expressly preempted. See 21 U.S.C. § 360k(a). De La Paz, Norman, and Richardson dismissed such claims. 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-approved label or on statements that were otherwise approved or mandated by the FDA, such claims are preempted”).6 6 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.” 2016 WL 1161578, at *15 n.21. Here, because the consistency between FDA-approved statements and Plaintiffs’ alleged misrepresentations is apparent, this Court should reach this question now and find that Plaintiffs’ claims are preempted, as Norman, De La Paz, and Richardson did. Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 24 of 36 Page ID #:2028 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 D. Plaintiffs’ Claims Based On An Alleged Failure To Warn Are Expressly And Impliedly Preempted. Plaintiffs base their failure to warn claims (and in part, their misrepresentation claims) on two theories; as other courts have held, neither theory falls within the preemption “gap.” First, Plaintiffs allege that Essure’s labeling failed to adequately warn consumers and the medical community of its risks. See Alexander Compl. ¶¶ 434- 436, 438. Plaintiffs, however, do 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; 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” were 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 concerning 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. Plaintiffs allege that Bayer could have unilaterally provided additional warnings through the “Changes Being Effected” process, see Alexander Compl. ¶¶ 96, 114, 438, but this allegation does not save their claims. “Because § 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 Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 25 of 36 Page ID #:2029 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 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). Second, Plaintiffs allege that Bayer failed to “timely file MDR’s and to report to the FDA the complaints that were not addressed by the device’s labeling and/or complaints that were occurring with an unexpected increase in severity and frequency.” Alexander Compl. ¶ 123; ¶ 435 (alleging failure to “report many of the approximately 16,000 complaints about Essure to the FDA or the public”); ¶ 449. Plaintiffs claim 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 Plaintiffs “would not have agreed to the Essure implant.” Id. ¶¶ 440, 442. Norman and De La Paz 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 connect defendants’ alleged reporting violations to [their] injuries.” Norman, 2016 WL 4007547; De La Paz, 159 F. Supp. 3d at 1096-97.7 To the contrary, several Plaintiffs acknowledge that FDA was in possession of much of the allegedly withheld information significantly before their procedures. See, e.g., Alexander Compl. ¶ 146 (alleging undergoing placement procedure in July 2014); ¶¶ 103-04 (alleging that FDA inspected an Essure facility in 2010 and identified certain MDRs that were not timely submitted); ¶ 105b (alleging that FDA inspector was provided “an Excel spreadsheet with . . . 16,581 complaints” during the December 2010 inspection). As in De La Paz, because “the FDA became aware of these adverse events more than a 7 Stengel, which applies in the 9th Circuit, held that a failure to warn claim based on a device manufacturer’s failure to report adverse events to the FDA is not preempted, 704 F.3d at 1233. Bayer respectfully submits that because Stengel runs counter to the Supreme Court’s holding in Buckman, Stengel was wrongly decided. See In re Medtronic, Inc., 623 F.3d at 1205. Regardless, Stengel does not support Plaintiffs’ claim here because of the causation issue addressed below at note 8. Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 26 of 36 Page ID #:2030 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 year before [most of the Plaintiffs] underwent the procedure,” and “did not require Bayer to take any action to further warn physicians or patients,” these allegedly withheld adverse events could not have caused Plaintiffs’ injuries. 159 F. Supp. 3d at 1097. Further, according to Plaintiffs’ allegations, FDA is now in possession of all of the supposedly withheld information, and has reviewed studies about the “undisclosed adverse events.” Alexander Compl. ¶ 110 (alleging that in a 2013 inspection, the FDA inspector was provided “a spreadsheet containing 16,047 complaints Conceptus received on the Essure device”); ¶ 443 (alleging that “the medical community and the FDA became aware of the undisclosed adverse events”).8 Despite having reviewed and considered these allegedly withheld reports and additional medical literature, FDA has never withdrawn its approval of Essure. To the contrary, FDA found “no conclusive evidence in the literature indicating any new or more widespread complications definitely associated with Essure,” RJN Ex. N (FDA Activities), 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, Plaintiffs’ attempt to invoke FDA’s recently proposed draft boxed warning and Patient Decision Checklist only further undermines their claims. 2016 WL 4007547, at *4. After holding a public hearing “regarding the safety and effectiveness of Essure,” during which FDA considered the allegedly withheld events, Alexander Compl. ¶¶ 441, 443, FDA did not require Bayer to change its disclosures on the percentage of patients who may be injured, the number of adverse events, or 8 Plaintiffs’ repeated attempt to highlight the number of complaints received by Bayer relative to the number of MDRs submitted, see, e.g., Alexander Compl. ¶ 105b, 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”). Plaintiffs point to no FDA finding that the complaints on these spreadsheets were adverse events that should have been reported to FDA but were not. Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 27 of 36 Page ID #:2031 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 the rate of unintended pregnancies. Instead, FDA proposed 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 (draft 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: Essure Labeling RJN, Ex. P (2012 PIB) RJN, Ex. O (2011 IFU) Proposed Box Warning RJN, Ex. Q (2016 Draft Guidance) • “To reduce the risk of uterine perforation, the procedure should be terminated if excessive force is required to achieve cervical dilation . . . .” (IFU, 2). • “Some patients implanted with the Essure System for Permanent Birth Control have reported adverse events, including perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reactions. Some of these reported events resulted in device removal that required abdominal surgery.” (Draft Guidance, 9). • “In rare cases, part of an Essure insert may puncture the fallopian tube.” (PIB, 7). • “Potential adverse events” include “[p]erforation of internal bodily structures other than the uterus and fallopian tube.” (IFU, 2). • “A very small percentage of women in the Essure procedure clinical trials reported recurrent or persistent pelvic pain.” (IFU, 2). • “Patients who are allergic to nickel may have an allergic reaction to the inserts. Symptoms include rash, itching and hives.” (PIB, 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.” (IFU, 2). Thus, Plaintiffs’ conclusory assertion that had Bayer “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 Plaintiffs Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 28 of 36 Page ID #:2032 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 and their physicians from obtaining Essure, is insufficient to allege causation. Alexander Compl. ¶¶ 440-41, 443; 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,9 this Court should dismiss the claim.10 E. Plaintiffs’ Loss of Consortium Claims Are Also Preempted. Plaintiffs’ loss of consortium claims should be dismissed because they derive entirely from Plaintiffs’ preempted claims. See Alexander Compl. ¶¶ 538-551. Accordingly, these derivative claims also fail as a matter of law. Eidson v. Medtronic, Inc., 40 F. Supp. 3d 1202, 1237-38 (N.D. Cal. 2014). II. PLAINTIFFS FAIL TO PLEAD THEIR FRAUD-BASED CLAIMS WITH PARTICULARITY. Moreover, Plaintiffs have not pled any of their claims sounding in fraud 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 9 McLaughlin lends Plaintiff little support. That case expressly recognized this critical element of causation, as did Stengel, 704 F.3d at 1233-34. See McLaughlin, 2016 WL 1161578, at *24 (noting that a 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 disclosures “to the ultimate users” regarding the risks of the device. 10 Plaintiffs’ inability to allege causation for each of their claims also prevents them from clearing the federal pleading threshold under Rule 12. The Complaint relies impermissibly on conclusory allegations that the alleged deficiencies in Essure’s design, manufacture, training, and warning “proximately” caused Plaintiffs’ injuries. See, e.g., Alexander Compl. ¶¶ 444, 466, 490, 502, 519, 534. Plaintiffs’ reliance on mere “labels and conclusions, and a formulaic recitation of the elements of a cause of action,” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 545 (2007), makes their 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. Their claims should be dismissed for this additional reason. Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 29 of 36 Page ID #:2033 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 the “who, what, when, where, and how of the misconduct charged.” Kearns, 567 F.3d at 1124, 1126-27. Here, Rule 9(b) applies to Plaintiffs’ claims for fraud, as well as their claims for negligent misrepresentation. UMG Recordings, Inc. v. Global Eagle Entm’t, Inc., 117 F. Supp. 3d 1092, 1106 (C.D. Cal. 2015) (“Claims 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 plaintiffs in De La Paz and McLaughlin, Plaintiffs do not allege which of the supposed misrepresentations they reviewed, how they relied on those alleged misrepresentations, or how they caused their alleged injuries. See De La Paz, 159 F. Supp. 3d at 1098-99.11 Instead, Plaintiffs conclusorily assert that they “justifiably relied on and/or were induced by Defendants’ intentional misrepresentations,” without any factual support or specificity. See Alexander Compl. ¶ 531. That is insufficient to meet the requirement of particularity. See McLaughlin, 2016 WL 1161578, at *17 (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”). III. CERTAIN PLAINTIFFS’ CLAIMS ARE ALSO TIME-BARRED. Finally, Plaintiffs Tracey Godfrey, Tara Erickson, Shirley McCalebb, Nicole Harrison, Amanda Cummings, Amanda Worsham, Jamie Bell, Jennifer Lindsey, Sarah Stockgt, Tanya Lee, Aretha Washington, Megan and Andrew Woolwine, Tina 11 Each of Plaintiffs’ fraud-based claims requires a showing of reliance and/or causation. See, e.g., Cal. Pub. Empls. Ret. Sys. v. Moody’s Investors Serv., Inc., 226 Cal. App. 4th 643, 661 (2014) (plaintiff must prove justifiable reliance to establish negligent misrepresentation); Manderville v. PCG&S Grp., Inc., 146 Cal. App. 4th 1486, 1498 (2007) (plaintiff must prove reliance in fraud or deceit claims). Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 30 of 36 Page ID #:2034 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 Matney, Holli McAlpin, and Kea Taylor’s (collectively, “SOL Plaintiffs”) claims should also be dismissed because they are barred on their face under California’s two- year statute of limitations for personal injury claims. Cal. Code Civ. Proc. § 335.1; Chione v. Medtronic, Inc. No. 14-cv-01043, 2015 WL 2151889, at *4 (S.D. Cal. May 7, 2015) (dismissing claims for negligence, strict liability, breach of express and implied warranty, and fraud as time-barred under § 335.1 because “[u]nder California law, personal injury claims based on defective products are subject to a two-year limitations period regardless of the particular legal theory invoked”); see also Rivas v. Safety-Kleen Corp., 98 Cal. App. 4th 218, 229-31 (Ct. App. 2002) (where a “fraud claim is merely the failure to warn claim recast as a claim for fraudulent concealment,” the statute of limitations for products liability claims applies); see, e.g., Alexander Compl. ¶ 523 (alleging fraud claim based on Bayer’s alleged fraudulent concealment of 16,047 complaints and other adverse events regarding Essure). Even though many of the SOL Plaintiffs are not California residents, application of California’s “governmental interest approach generally leads California courts to apply California law” concerning the statute of limitations, “and especially so where California’s statute would bar a claim.” Deutsch v. Turner Corp., 324 F.3d 692, 716-17 (9th Cir. 2003) (citations omitted); Theranos, Inc. v. Fuisz Pharma LLC, 876 F. Supp. 2d 1123, 1131 (N.D. Cal. 2012) (“Federal courts sitting in California and applying a Deutsch analysis consistently conclude that California’s statute of limitations applies when faced with a choice-of-law concerns, absent a rare exception or extraordinary interest by a foreign state to keep alive the claims.”).12 Accordingly, each of the SOL Plaintiffs’ claims is subject to a two-year statute of limitations. The limitations period starts to run “from the moment a claim accrues.” Aryeh v. Canon Bus. Solutions, Inc., 55 Cal. 4th 1185, 1191 (2013). A claim accrues from 12 See also Medinger v. Bayer HealthCare Pham. Inc., __F. App’x__, 2016 WL 3582800 at *2 (2d Cir. July 1, 2016) (“California courts consider a foreign state to have ‘no interest’ in applying its statute of limitations to actions in which its residents are not defendants”). Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 31 of 36 Page ID #:2035 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 “the occurrence of the last element essential to the cause of action,” id., generally “the date of injury,” Rivas, 98 Cal. App. 4th at 224. “A plaintiff whose complaint shows on its face that his claim would be barred without the benefit of the discovery rule must specifically plead facts to show (1) the time and manner of discovery and (2) the inability to have made earlier discovery despite reasonable diligence.” McKelvey v. Boeing N. Am. Inc., 74 Cal. App. 4th 151, 160-61 (Ct. App. 1999), superseded by statute on other grounds as stated in Grisham v. Philip Morris, 40 Cal. 4th 623, 637 n.8 (2007). “The burden is on the plaintiff to show diligence, and conclusory allegations will not withstand demurrer.” Id. at 160-61. The tolling stops as soon as plaintiff has reason to “at least suspect[] . . . that someone has done something wrong to him.” Norgart v. Upjohn Co., 21 Cal. 4th 383, 397 (1999) (internal quotations omitted).13 Here, the SOL Plaintiffs each had reason to suspect and investigate their claims more than two years before they filed suit. Each alleges that she learned, outside the limitations period, that Essure either caused her symptoms or failed to prevent her pregnancy, contrary to the representations of safety and efficacy that they allegedly relied upon in obtaining the device. Plaintiffs Tracey Godfrey, Tara Erickson, Shirley McCalebb, Nicole Harrison, Amanda Cummings, Amanda Worsham, Jamie Bell, Jennifer Lindsey, Sarah Stockgt, Tanya Lee, and Aretha Washington each generally allege that they obtained the Essure device outside of the limitations period based on certain representations of safety and efficacy made by their physicians and unspecified Essure marketing 13 Similarly, for the doctrine of fraudulent concealment to toll the statute, a “plaintiff must show: (1) when the fraud was discovered; (2) the circumstances under which it was discovered; and (3) that the plaintiff was not at fault for failing to discover it or had no actual or presumptive knowledge of facts sufficient to put him on inquiry.” Clemens v. DiamlerChrysler Corp.,, 534 F.3d 1017, 1024 (9th Cir. 2008). Like the discovery rule, “fraudulent concealment does not come into play, whatever the lengths to which a defendant has gone to conceal the wrongs, if a plaintiff is on notice of a potential claim.” Rita M. v. Roman Catholic Archbishop, 187 Cal. App. 3d 1453, 1460 (1986). Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 32 of 36 Page ID #:2036 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 materials. They each further allege that soon thereafter, they began to experience symptoms including abnormal bleeding, abdominal or pelvic pain, and a variety of other symptoms. And each alleges that more than two years before the filing of the her complaint, she learned from her physician that her Essure device had migrated, perforated her uterus or fallopian tubes, or otherwise caused her symptoms, and must be removed by surgery. See, e.g., Alexander Compl. ¶¶ 260-63 (Godfrey); Arvizu Compl. ¶¶ 166-67 (Erickson), ¶¶ 292-93 (McCalebb), Harrison Compl. ¶¶ 138-39 (Harrison), ¶¶ 150-52 (Cummings), ¶¶ 185-86 (Worsham), ¶ 233 (Bell); ¶¶ 251-52 (Lindsey), ¶¶ 371-72 (Stockigt); Brock Compl. ¶ 249 (Lee), ¶ 339 (Washington). Plaintiffs Megan and Andrew Woolwine, Tina Matney, Holli McAlpin, and Kea Taylor each allege that contrary to the representations regarding Essure’s efficacy that she relied upon, they nevertheless became pregnant-outside the limitations period- following their placement procedures. See, e.g., Alexander Compl. ¶¶ 422-24 (Woolwine); Arvizu Compl. ¶¶ 264-65 (Matney), ¶¶ 275-78 (McAlpin); Harrision Compl. ¶ 261 (Taylor). Ms. McAlpin’s doctor in particular told her that “there was no way that she should have become pregnant.” Arvizu Compl. ¶ 278. Based on these allegations, the SOL Plaintiffs’ claims accrued when each learned, outside the limitations period, that Essure had allegedly caused her symptoms or failed to prevent her pregnancy, contrary to the representations of safety and efficacy that she allegedly relied upon. No later than that point, each should have at least suspected the basis for her claims. See, e.g., Darringer v. Intuitive Surgical, Inc., 2015 WL 4623935, at *3 (N.D. Cal. Aug. 3, 2015) (dismissing plaintiffs’ claims based on use of a medical device during surgery, because his claims accrued on the date of the surgery); Erickson v. Boston Sci. Corp., 846 F. Supp. 2d 1085, 1095 (C.D. Cal. 2011) (statute of limitations began to run when “[p]laintiff…should have suspected[] that Defendants’ pacemakers were allegedly defective” because “it failed to operate properly and required replacement . . . less than three years after it was implanted”); In re Mirena IUD Prods. Liab. Litig., No. 7:14-cv-05229, 2015 WL 144214, at *7 Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 33 of 36 Page ID #:2037 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 (S.D.N.Y. Jan. 9, 2015) (dismissing claims arising from alleged injuries from use of a birth control device as time-barred under California law, because the claims accrued as of the date of device removal), aff’d sub nom. Medinger v. Bayer Healthcare Pharm. Inc., __ F. App’x __, 2016 WL 3582800 (2d Cir. July 1, 2016); Goldrich v. Natural Y Surgical Specialties, Inc., 25 Cal. App. 4th 772, 779-80 (Ct. App. 1994) (claims based on plaintiff’s breast implant accrued as early as when her doctors recommended implant removal, which “by itself is sufficient to make a reasonable person suspicious” of the basis of her claims, and at the very latest when she underwent removal surgery). SOL Plaintiffs’ conclusory invocation of the discovery rule and the fraudulent concealment doctrine does not save their stale claims. Each had reason to at least suspect the factual basis of her claims, and investigate the alleged “wrongdoing” by Bayer, when she learned that she had been injured by her device contrary to the representations and warnings she allegedly relied upon. This is particularly true since Plaintiffs’ claims are largely based on allegations that Bayer concealed the risks and overstated the efficacy of the device, including supposed misrepresentations about the very injuries they allegedly sustained, see supra at 15-19. Thus, when these Plaintiffs allegedly learned that they had been injured by the device, or that they device had not prevented their pregnancies, they also knew that Bayer had not (under their theory) adequately informed them of these risks, triggering a basis to suspect wrongdoing and begin investigation. See, e.g., Plumlee v. Pfizer, Inc., No. 13-CV-414-LHK, 2014 WL 4275519, at *8 (N.D. Cal. Aug. 29, 2014) (holding that where “Plaintiff pleads that she detrimentally relied on Zoloft’s advertised effectiveness and was fully aware that Zoloft failed to treat her depression,” she had “reason at least to suspect a factual basis for her claims that the Zoloft advertising and label were misleading” when she determined that Zoloft was ineffective (emphasis added) (internal quotations omitted)); McLaughlin, 2016 WL 1161578, at *17 n.22 (“[I]t is difficult to comprehend how Plaintiffs would not have been alerted to the fact of the alleged Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 34 of 36 Page ID #:2038 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 25 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES misrepresentations well prior to September 29, 2014,” given that “Plaintiffs are alleged to have suffered considerable and painful complications due to the migration of Essure” before then); Norgart, 21 Cal. 4th at 397 (plaintiff had reason to discover their wrongful death claim against drug manufacturer soon after decedent’s suicide because they “had reason to learn of a possible connection” between the drug and suicidal tendencies); see also Platt Elec. Supply, Inc. v. EOFF Elec., Inc., 522 F.3d 1049, 1059 (9th Cir. 2008) (once plaintiff learned that the product was “defective and posed a safety hazard, it was on notice that” representations regarding the safety of the product were “factually false”); Marino v. Countrywide Fin. Corp., 602 F. App’x 403, 405 (9th Cir. 2015) (neither the discovery rule nor fraudulent concealment saved plaintiff’s claim where he “clearly had reason to suspect an injury and some wrongful cause”). Thus, these plaintiffs’ claims also are time barred. CONCLUSION For these reasons, the Court should dismiss Plaintiffs’ claims pursuant to Fed. R. Civ. P 8, 9(b), and 12(b)(6). Dated: October 4, 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 Jonathan F. Cohn (Pro Hac Vice to be filed) Rebecca K. Wood (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 jfcohn@sidley.com Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 35 of 36 Page ID #:2039 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 26 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES rwood@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 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 36 of 36 Page ID #:2040 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 JACQUELINE ALEXANDER, et al., Plaintiffs, v. BAYER CORP., BAYER HEALTHCARE LLC, BAYER ESSURE INC.; BAYER HEALTHCARE PHARMACEUTICALS, INC.; and DOES 1 -10, inclusive, Defendants. Case No. 2:16-cv-06822-MWF-MRW [PROPOSED] ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS Date: November 21, 2016 Time: 10:00 a.m. Location: Courtroom 1600 Judge: Hon. Michael Fitzgerald Case 2:16-cv-06822-MWF-MRW Document 15-1 Filed 10/04/16 Page 1 of 2 Page ID #:2041 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 Plaintiffs’ Complaints (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 Plaintiffs’ claims are preempted by federal law and fail to satisfy the applicable federal pleading standards. Accordingly, Bayer’s Motion is GRANTED. Plaintiffs’ Complaints are hereby dismissed with prejudice. IT IS SO ORDERED. Dated: __________, 20__ HON. MICHAEL FITZGERALD Case 2:16-cv-06822-MWF-MRW Document 15-1 Filed 10/04/16 Page 2 of 2 Page ID #:2042