De La Paz v. Bayer AG et al, No. 3:2015cv03995 - Document 57 (N.D. Cal. 2016)
Court Description: ORDER GRANTING DEFENDANTS' MOTION TO DISMISS by Hon. William Alsup granting 33 Motion to Dismiss.(whalc1, COURT STAFF) (Filed on 2/2/2016)
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De La Paz v. Bayer AG et al Doc. 57 1 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE NORTHERN DISTRICT OF CALIFORNIA 8 9 TANYA DE LA PAZ, an individual, 12 13 14 15 16 No. C 15-03995 WHA Plaintiff, 11 For the Northern District of California United States District Court 10 v. BAYER HEALTHCARE LLC, a Delaware limited liability company, BAYER ESSURE INC., a Delaware corporation, BAYER HEALTHCARE PHARMACEUTICALS, INC., a Delaware Corporation, and DOES 1–10, inclusive, ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS Defendants. / 17 18 INTRODUCTION 19 In this personal-injury action involving a permanent female contraceptive device, 20 defendants have moved to dismiss plaintiff’s amended complaint. For the reasons stated below, 21 defendants’ motion is GRANTED. 22 STATEMENT 23 Plaintiff Tanya De La Paz is an individual who resides in South Carolina who sought to 24 have Essure, a permanent female contraceptive device, implanted in her fallopian tubes in July 25 2012. This action arises from several complications that De La Paz suffered as a result of 26 alleged defects with the Essure device. 27 Defendants Bayer HealthCare LLC, Bayer Essure Inc., and Bayer HealthCare 28 Pharmaceuticals, Inc., (collectively “Bayer”), manufactured, sold, distributed, and marketed Essure. Essure was first designed and manufactured by Conceptus, Inc., which merged with Dockets.Justia.com 1 Bayer in 2013 (for the purpose of this order, references to “Bayer” include Conceptus). Bayer 2 also trained physicians how to use Essure and equipment related to implanting the device. 3 1. THE ESSURE DEVICE. 4 Bayer designed the Essure device to insert a metal coil known as a “micro-insert” into 5 each of a patient’s fallopian tubes. Once released, the micro-inserts expanded and anchored 6 themselves into the fallopian tubes, and fibers in the micro-inserts elicited tissue growth, 7 ultimately blocking the fallopian tubes and preventing pregnancy. Patients’ physicians 8 implanted the micro-inserts with a “disposable delivery system” that included a handle for the 9 physician to control the delivery and release of the micro-inserts, which were attached to the 11 For the Northern District of California United States District Court 10 handle with a wire (Amd. Compl. ¶¶ 19–21, 24–26). Physicians used hysteroscopic cameras in order to visualize the implanting procedure. 12 Bayer did not manufacture hysteroscopic equipment; however, it provided equipment 13 manufactured by a third party to physicians as part of its efforts to market Essure in exchange 14 for physicians’ commitments to purchase two Essure kits per month and trained them in the use 15 of that equipment (id. ¶¶ 22–23, 50–64). 16 Three months following any implanting procedure, patients were scheduled for 17 hysterosalpingogram tests, which confirmed whether the micro-inserts anchored in the correct 18 location and that tissue had grown to completely block the fallopian tubes as intended. 19 2. PREMARKET APPROVAL. 20 Medical devices are regulated by the Food and Drug Administration pursuant to the 21 Food, Drug, and Cosmetics Act and the Medical Device Amendments of 1976 (“MDA”). 21 22 U.S.C. 360c et seq. Pursuant to the MDA, Essure was (and remains) designated as a Class III 23 medical device, which means its design, manufacturing process, and labeling underwent the 24 rigorous scrutiny of the FDA’s premarket approval process. See 21 U.S.C. 360e. A device is 25 classified under Class III (and therefore subject to premarket approval) when the less stringent 26 classifications cannot provide reasonable assurance of its safety and effectiveness, and the 27 device is used either “in supporting or sustaining human life or for a use which is of substantial 28 2 1 importance in preventing impairment of human health” or it “presents a potential or 2 unreasonable risk of illness or injury.” 21 U.S.C. 360c(a)(1)(C). 3 A Class III device may only win approval to be marketed if the FDA finds, based on a 4 multi-volume application including detailed investigations into the safety and effectiveness of 5 the device and its labeling, that there is a “reasonable assurance of safety and effectiveness of 6 [that] device . . . .” 21 U.S.C. 360e(d); see also Riegel v. Medtronic, Inc., 522 U.S. 312, 317–18 7 (2008) (describing premarket approval in detail). The determination of the safety and 8 effectiveness of a device is made in part by “weighing any probable benefit to health from the 9 use of the device against any probable risk of injury or illness from such use.” 21 U.S.C.A. 360c. 11 For the Northern District of California United States District Court 10 The FDA approved Essure through the premarket approval process in 2002 subject to 12 certain conditions, such as regular reporting on efficacy, reporting of all adverse events, and 13 seeking approval for any change to the device (Defs.’ Request for Judicial Notice, Exh. B). 14 Bayer received several Form 483s, which are reports written by FDA investigators 15 revealing potential violations discovered during an inspection of a manufacturing facility. 16 Specifically, in June 2008, Bayer received a Form 483 that indicated that since 2005, it had 17 been “manufacturing medical devices . . . at an unlicensed facility,” that it had “failed to 18 maintain procedures to control documents” relating to the maintenance of pre-sterile and post- 19 sterile quarantine cages, and that its facility “no longer use[d] pre-sterile and post-sterile cages” 20 (Amd. Compl. ¶¶ 105(d)–(e); Defs.’ Supp. Request for Judicial Notice, Exh. D at 1).1 In January 2011, Bayer received another Form 483 that indicated its contract 21 22 manufacturer had “erroneously used non-conforming material in a validation protocol without 23 adequately documenting the disposition of the material,” although “the FDA inspection did not 24 note any deficiencies with regard [to] the firm’s handling of non-conforming material” and that 25 1 26 27 28 A “court may consider a writing referenced in a complaint but not explicitly incorporated therein if the complaint relies on the document and its authenticity is unquestioned.” Swartz v. KPMG LLP, 476 F.3d 756, 763 (9th Cir. 2007). De La Paz refers to these Form 483s as the factual bases for her claims that Bayer used non-conforming material in the design and manufacture of Essure, and she does not contest the authenticity of the Form 483s submitted by Bayer. Accordingly, this order considers those documents as if incorporated into the complaint in full. The Form 483s in question are Exhibits C and D to Bayer’s Supplemental Request for Judicial Notice. 3 1 “the firm corrected this discrepancy prior to the close of the inspection.” Finally, that Form 483 2 noted that Bayer “had not properly evaluated eight complaints of peritoneal perforation for 3 reporting to the FDA as an adverse event” (Amd. Compl. ¶¶ 105(b)–(c); Defs.’ Supp. Request 4 for Judicial Notice, Exh. C at 1). 5 3. DE LA PAZ’S EXPERIENCE WITH ESSURE. 6 De La Paz underwent a procedure to have Essure implanted in July 2012; however, the 7 implanting physician abandoned the procedure after the device perforated one of De La Paz’s 8 fallopian tubes, which caused bleeding. De La Paz returned to her physician in September 2012 9 for a second attempt, which the physician completed. After the second procedure, De La Paz 11 For the Northern District of California United States District Court 10 began to experience severe bleeding and constant pain (Amd. Compl. ¶¶ 71–72). In December 2012, De La Paz returned to her physician for the standard 12 hysterosalpingogram test to confirm that the device had anchored in the proper location and 13 elicited tissue growth. The test revealed that the left micro-insert was properly implanted, but 14 the right micro-insert appeared stretched or broken. Upon discovering this irregularity, De La 15 Paz’s physician contacted Bayer, which stated that the right micro-insert needed to be removed. 16 In February 2013, De La Paz underwent surgery to have her right fallopian tube removed along 17 with the broken micro-insert that had anchored there, which she had been informed would 18 relieve her symptoms (Amd. Compl. ¶¶ 73–76). 19 De La Paz continued to experience daily pain and heavy bleeding, as well as weight 20 gain, stomach issues, pelvic pain, and mental and emotional anguish. She discovered, through 21 Internet research, that other women had similar ongoing symptoms due to the Essure device. In 22 September 2015, De La Paz underwent surgery to have the micro-insert in her left fallopian 23 tube removed (Amd. Compl. ¶¶ 77–79). 24 * * * 25 De La Paz commenced this action in federal court here in San Francisco in September 26 2015 on the basis of diversity jurisdiction. Bayer moved to dismiss the complaint in October 27 2015. In lieu of a response to Bayer’s motion, De La Paz filed an amended complaint, asserting 28 ten claims against Bayer based on the injuries she allegedly suffered as a result of having the 4 1 Essure device implanted. Specifically, De La Paz’s claims are as follows: (1) manufacturing 2 defect, (2) design defect, (3) negligence, (4) failure to warn, (5) strict liability, (6) breach of 3 implied warranty, (7) breach of express warranty, (8) negligent misrepresentation, 4 (9) fraudulent misrepresentation, (10) fraudulent concealment.2 Bayer filed the instant renewed motion to dismiss the amended complaint in November 5 6 2015. This order follows full briefing, including supplemental briefs regarding preemption, and 7 oral argument.3 8 ANALYSIS 9 Bayer contends that each of De La Paz’s claims is expressly preempted by the MDA’s requirements for premarket approval of Class III medical devices, and that any claims that 11 For the Northern District of California United States District Court 10 survive express preemption are impliedly preempted because the FDA has exclusive authority 12 to enforce the MDA. De La Paz responds that her claims overcome the hurdles of both express 13 and implied preemption. To that extent, Bayer further contends that De La Paz has failed to 14 plead a causal link between the conduct alleged and her injuries and that she has failed to plead 15 her fraud claims with the particularity required by Rule 9(b). Finally, Bayer argues that De La 16 Paz’s claims are barred by California’s two-year statute of limitations on personal-injury 17 claims. 18 This order begins by detailing the scope of express and implied preemption as they 19 apply to Class III medical devices. It then addresses the substance of each of De La Paz’s 20 21 2 22 23 24 25 The parties agree that California law, not South Carolina law, applies. The only relevant conflict identified between the laws of either state is that South Carolina’s statute of limitations for personal injury claims is three years, while California’s is two years. Compare S.C. Code § 15-3-530 with Cal. Civ. Proc. § 335.1. California’s approach to choice of law with regard to a statute of limitations “generally leads California courts to apply California law, and especially so where California’s statute would bar a claim.” Deutsch v. Turner Corp., 324 F.3d 692, 716 (9th Cir 2003). This order applies California law to the state law issues herein. 3 26 27 28 The undersigned related three other cases asserting the same claims against these defendants based on alleged defects relating to Essure. Salaiz v. Bayer HealthCare LLC, et al., No. 15-4952 (N.D. Cal.); Ruiz v. Bayer HealthCare LLC, et al., No. 15-4953 (N.D. Cal.); Patterson v. Bayer HealthCare LLC, et al., No. 15-5088 (N.D. Cal.). A consolidated case with five plaintiffs is also pending in the Eastern District of Pennsylvania. MacLaughlin v. Bayer, Corp., et al., No. 14-7315 (Judge John R. Padova). Judge Padova held oral argument on defendants’ motion for judgment on the pleadings in that action on January 11, 2016. That motion remains pending. 5 1 theories of liability, which she contends overcome the limitations of express and implied 2 preemption. Finally, this order addresses Bayer’s statute-of-limitations argument. 3 1. 4 Section 360k(a) of Title 21 of the United States Code includes an express preemption 5 6 7 PREEMPTION. provision for requirements of the MDA: Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement — 8 9 11 For the Northern District of California United States District Court 10 (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. 12 Subsection (b) allows the FDA to exempt specific state or local laws from the preemptive sweep 13 of Section 360k(a); however, that exemption is not applicable here because the FDA has not 14 exempted the state laws that make up De La Paz’s claims from preemption. 15 De La Paz brings this action against Bayer because she contends that the Essure device 16 she had implanted in 2012 was unsafe and caused bleeding, pain, and other injuries including 17 the removal of the micro-insert in her left fallopian tube. She also contends that Bayer 18 misrepresented the safety and effectiveness of the device. 19 The parties agree that as a Class III device that won conditional premarket approval, 20 Essure is subject to “requirements” under the MDA. Bayer contends that De La Paz’s claims 21 are based on state laws that impose requirements that are “different from, or in addition to” the 22 federal requirements applicable to Essure and that relate to its “safety and effectiveness of the 23 device or to any other matter included in” an applicable requirement, triggering express 24 preemption under Section 360k(a). 25 In Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008), the Supreme Court considered 26 whether a plaintiff could bring state law tort claims against a device manufacturer 27 “notwithstanding compliance with the relevant federal requirements . . . .” Riegel held such 28 6 1 claims preempted, but left open the possibility that a plaintiff could bring state law claims 2 premised on conduct that violated federal law: 3 4 5 State requirements are preempted under the MDA only to the extent that they are “different from, or in addition to” the requirements imposed by federal law. Thus, [Section 360k(a)] does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements. 6 Ibid. In other words, to the extent Bayer has complied with the MDA, any state law claims 7 based on the safety and effectiveness of Essure would be “different from or in addition to” the 8 requirements of the MDA and therefore expressly preempted. On the other hand, De La Paz’s 9 claims may escape express preemption if she can allege that Bayer has violated both a federal 10 To the extent De La Paz can overcome express preemption, she faces a second challenge For the Northern District of California United States District Court duty under the MDA as well as a parallel state duty. 11 12 — implied preemption. The FDCA provides that enforcement of its requirements (including the 13 MDA) “shall be by and in the name of the United States.” 21 U.S.C. 337(a). That is, “the 14 Federal Government rather than private litigants . . . [is] authorized to file suit for 15 noncompliance with the medical device provisions.” Buckman Co. v. Plaintiffs’ Legal 16 Committee, 531 U.S. 341, 349 n.4 (2001). Thus, a claim that “exist[s] solely by virtue” of 17 federal requirements (such as a claim for fraud in submissions to the FDA during the premarket 18 approval process) is impliedly preempted by the MDA, while claims that rely on “traditional 19 state tort law” may proceed (to the extent they can overcome express preemption). Ibid. 20 Thus, our court of appeals has recognized that there is a “‘narrow gap through which a 21 state-law claim must fit to escape preemption by the [MDA].” Perez v. Nidek Co., Ltd., 711 22 F.3d 1109, 1120 (9th Cir. 2013). The decision in Perez stated: 23 24 25 The plaintiff must be suing for conduct that violates the [MDA] (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the [MDA] (such a claim would be impliedly preempted under Buckman). 26 Ibid. (quoting In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 27 1204 (8th Cir. 2010)). De La Paz contends that each of her claims falls within this narrow gap 28 either by alleging violations of parallel duties under state and federal law or by alleging 7 1 violations of state law outside the scope of the MDA. Bayer responds that to the extent De La 2 Paz alleges it violated both the MDA and specific state law tort duties, her claims are 3 inadequately pled. 4 Our court of appeals and district courts in our circuit have examined the preemptive 5 effect of the MDA regarding state law tort claims against medical device manufacturers in more 6 than sixty decisions since Riegel. Before addressing De La Paz’s specific claims, this order 7 pauses to review that extensive body of decisional law. 8 9 The overwhelming majority of state law tort claims, including claims based on negligence, design defect, manufacturing defect, failure to warn, fraud, negligent misrepresentation, breach of implied and express warranties, unfair competition, and false 11 For the Northern District of California United States District Court 10 advertising, have been held preempted. See, e.g., Perez v. Nidek Co., Ltd., 711 F.3d 1109, 12 1117–20 (9th Cir. 2013); Malonzo v. Mentor Worldwide, LLC, No. 14-01144, 2014 WL 13 2212235, at *3 (N.D. Cal. May 28, 2014) (Judge Jeffrey S. White); Knoppel v. St. Jude Med. 14 Inc., No. 13-383, 2013 WL 3803612, at *4 (C.D. Cal. May 7, 2013) (Judge James V. Selna); 15 Lowe v. Medtronic, Inc., No. 11-9551, 2012 WL 3656468, at *1 (C.D. Cal. May 9, 2012) (Judge 16 Manuel L. Real); Rhynes v. Stryker Corp., No. 10-5619, 2011 WL 5117168, at *5 (N.D. Cal. 17 Oct. 27, 2011) (Judge Samuel Conti); Williams v. Allergan USA, Inc., No. 09-1160, 2009 WL 18 3294873, at *4 (D. Ariz. Oct. 14, 2009) (Judge G. Murray Snow). Every design-defect claim 19 considered within our circuit has been held preempted (such a claim would require allegations 20 of deviations from the FDA-approved design). See Funke v. Sorin Group USA, Inc., No. 15- 21 01182, 2015 WL 7747011, at *6 (C.D. Cal. Nov. 24, 2015) (Judge Cormac J. Carney). 22 Nevertheless, certain claims have survived preemption, as now discussed. 23 Four decisions have allowed manufacturing-defect claims to survive preemption, and 24 each required specific allegations “that the manufacturing of the device both fell short of the 25 FDA’s requirements for manufacturing and — based on the same deficiency — was defectively 26 manufactured under California law.” Id. at *6 (holding manufacturing defect inadequately pled, 27 but giving leave to amend); see also Seedman v. Cochlear Americas, No. 15-00366, 2015 WL 28 4768239, at *8 (C.D. Cal. Aug. 10, 2015) (Judge James V. Selna); O’Neil v. St. Jude Med., Inc., 8 1 No. 13-0661, 2013 WL 6173803, at *2 (W.D. Wash. Nov. 22, 2013) (Judge Robert S. Lasnik); 2 Prudhel v. Endologix, Inc., No. 09-0661, 2009 WL 2045559, at *8 (E.D. Cal. July 9, 2009) 3 (Judge Lawrence K. Karlton). 4 In Stengel v. Medtronic Inc., 704 F.3d 1224, 1233 (9th Cir. 2013) (en banc), our court of 5 appeals considered a claim under Arizona law that imposed a duty to warn of the dangers of a 6 product on manufacturers. Stengel held that the MDA did not preempt the state law claim 7 inasmuch as it imposed a duty to warn third parties (such as the FDA), if such a warning offered 8 “reasonable assurance that the information [would] reach those whose safety depend[ed] on 9 their having it.” Ibid. (quoting Anguiano v. E.I. DuPont de Nemours & Co., 808 F. Supp. 719, 723 (D. Ariz. 1992) (Judge Richard Bilby), aff’d 44 F.3d 806 (9th Cir. 1995)). Numerous 11 For the Northern District of California United States District Court 10 decisions have allowed failure-to-warn-the-FDA claims in light of Stengel. See, e.g., Funke v. 12 Sorin Group USA, Inc., No. 15-01182, 2015 WL 7747011, at *4 (C.D. Cal. Nov. 24, 2015) 13 (Judge Cormac J. Carney); Thibodeau v. Cochlear Ltd., No. 13-02184, 2014 WL 3700868, at *4 14 (D. Ariz. July 25, 2014) (Judge David G. Campbell). 15 In Coleman v. Medtronic, Inc., 223 Cal. App. 4th 413, 428–29 (2014), as modified (Feb. 16 3, 2014) (quoting Anderson v. Owens-Corning Fiberglas Corp., 53 Cal. 3d 987, 1002 (1991)), 17 the California Court of Appeal specifically acknowledged that California’s duty to warn of 18 product defects extended to warning the FDA “if that is the sole permissible mechanism for 19 publicizing the additional risks associated with a medical device.” The California Court of 20 Appeal noted that to prevail on a failure-to-warn-the-FDA claim, the plaintiff “will ultimately 21 have to prove that if [the defendant] had properly reported the adverse events to the FDA as 22 required under federal law, that information would have reached [the plaintiff’s] doctors in time 23 to prevent” the alleged injuries. Id. at 430 (quoting Stengel, 704 F.3d at 1234 (Judge Paul J. 24 Watford, concurring)). 25 Indeed, numerous district court decisions have also recognized that a causal link 26 between a manufacturer’s failure to warn the FDA and a plaintiff’s injury is a necessary element 27 of such a claim. Michajlun v. Bausch & Lomb, Inc., No. 14-1365, 2015 WL 1119733, at *8 28 (S.D. Cal. Mar. 11, 2015) (Judge Jeffrey T. Miller); Eidson v. Medtronic, Inc., 981 9 1 F. Supp. 2d 868, 889 (N.D. Cal. 2013) (Judge Lucy H. Koh); Simmons v. Boston Scientific 2 Corp., No. 12-7962, 2013 WL 1207421, at *5 (C.D. Cal. Mar. 25, 2013) (Judge Percy 3 Anderson); Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085, 1092 (C.D. Cal. 2011) 4 (Judge Andrew J. Guilford). 5 In McClellan v. I-Flow Corp., 776 F.3d 1035, 1041 (9th Cir. 2015), our court of appeals 6 recognized that a plaintiff could bring a negligence per se claim premised on a manufacturer’s 7 failure to comply with the FDA’s labeling requirement without running afoul of MDA 8 preemption. That decision distinguished the fraud-on-the-FDA claim that Buckman held 9 impliedly preempted from the negligence per se claim because the former relied on a duty that existed solely due to the premarket approval process (and thereby fell within the FDA’s 11 For the Northern District of California United States District Court 10 exclusive jurisdiction), while the latter relied on an independent state law duty (albeit one that 12 incorporated the standard of care from federal law). That is, absent the premarket approval 13 process, manufacturers would still be required to comply with the state law standard of care 14 with regard to warnings. 15 Several decisions have allowed warranty, fraud, and misrepresentation claims arising 16 out of marketing and promotion of off-label uses for devices (uses that have not been approved 17 by the FDA) to escape preemption. “The FDA forbids [off-label promotion] because the FDA’s 18 review of a device’s safety and effectiveness was not universal; it focused only on the intended 19 use specified by a manufacturer.” Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977, 990 (D. 20 Ariz. 2013) (Judge G. Murray Snow); see also Anderson v. Medtronic, Inc., No. 14-00615, 21 2015 WL 2115342, at *7 (S.D. Cal. May 6, 2015) (Judge Cynthia Bashant); Poll v. Stryker 22 Sustainability Solutions, Inc., No. 13-440, 2014 WL 199150, at *6 (D. Ariz. Jan. 17, 2014) 23 (Judge Cindy K. Jorgenson); Eidson v. Medtronic, Inc., 981 F. Supp. 2d 868 (N.D. Cal. 2013) 24 (Judge Lucy H. Koh); Kashani-Matts v. Medtronic, Inc., No. 13-01161, 2013 WL 6147032, at 25 *5 (C.D. Cal. Nov. 22, 2013) (Judge Cormac J. Carney); Alton v. Medtronic, Inc., 970 F. Supp. 26 2d 1069, 1104 (D. Or. 2013) (Judge Paul Papak). 27 28 Suckow v. Medtronic, Inc., 971 F. Supp. 2d 1042, 1049 (D. Nev. 2013) (Judge Gloria M. Navarro), recognized that a claim for breach of express warranty based on statements that went 10 1 “beyond the FDA approved statements,” even with regard to approved uses, could survive 2 preemption, to the extent it did not rely on a contradiction of the FDA’s conclusions in the 3 premarket approval process. Suckow ultimately dismissed those claims as inadequately pled. 4 Ibid. Thus, although there remains the possibility that warranty or fraud claims based on 5 statements relating to an FDA-approved use might survive preemption, no such claim has 6 been pled. * 7 * * 8 This order now addresses each of De La Paz’s claims grouped into the following 9 categories — manufacturing defect, design defect, failure to warn, negligent training, breach of warranty, and misrepresentation/fraud. 11 For the Northern District of California United States District Court 10 2. 12 De La Paz’s first claim alleges that the Essure device she had implanted in 2012 suffered 13 from manufacturing defects that rendered the product “unreasonably dangerous” and caused her 14 to undergo the surgical removal of the micro-insert in her left fallopian tube, among other 15 injuries. Her fifth claim alleges that as the manufacturer and supplier of Essure, Bayer is 16 strictly liable for any injuries caused by manufacturing defects in the product (among other 17 bases for strict liability discussed below) (Amd. Compl. ¶¶ 107–12, 146–48, 152). 18 MANUFACTURING-DEFECT CLAIMS. De La Paz contends that her manufacturing-defect claims escape express preemption 19 because she has plausibly alleged that Bayer allowed its Essure devices to become “adulterated” 20 as defined by the MDA. She further contends that the claims escape implied preemption 21 because under California law, Bayer is strictly liable for any injuries resulting from 22 manufacturing defects in Essure devices. 23 The MDA provides that a device is deemed “adulterated” if “the methods used in, or the 24 facilities or controls used for, its manufacture, packing, storage, or installation are not in 25 conformity with applicable requirements” in the FDA’s requirements for that device. 21 U.S.C. 26 351(h). De La Paz alleges that Bayer allowed its Essure devices to become adulterated, based 27 on the observations of FDA investigators during inspections of Bayer’s facilities as documented 28 in certain Form 483s issued in 2008 and 2011. Specifically, she alleges that the investigators 11 1 indicated that Bayer “erroneously used non-conforming material,” “no longer use[d] pre-sterile 2 and post-sterile cages,” and “failed to obtain a valid license . . . prior to manufacturing medical 3 devices” (Amd. Compl. ¶¶ 105(c)–(e)). The Form 483s offer plausible support for the inference 4 that Bayer produced some adulterated devices, even if not conclusive. 5 Nevertheless, to escape implied preemption De La Paz must allege that the irregularities 6 documented in the Form 483s resulted in a manufacturing defect that caused her injuries. In 7 other words, she cannot state a claim based solely on Bayer’s adulteration of certain Essure 8 devices, since any such claim would “exist solely by virtue of the [MDA] . . . requirements.” 9 Buckman, 531 U.S. at 353. De La Paz has failed to allege such a manufacturing defect. The complaint offers no description of the “non-conforming material” used in 11 For the Northern District of California United States District Court 10 manufacturing the device, or how the use of that material caused a defect in the product itself. 12 In fact, the Form 483 indicated that Bayer’s contract manufacturer used the “non-conforming 13 material” in a validation protocol, not in the actual manufacture of the product. Moreover, the 14 report indicated that the manufacturer had erred by failing to adequately document the 15 disposition of that material, not by using the material itself (Defs.’ Request for Judicial Notice, 16 Exh. C). De La Paz has provided no basis for concluding that the failure to document the 17 disposition of non-conforming material in a validation protocol caused a manufacturing defect 18 in any Essure device. 19 Similarly, neither the complaint nor the Form 483s referenced offer any explanation of 20 the function of “pre-sterile and post-sterile cages” in the manufacturing process, nor do they 21 offer any explanation for how Bayer’s alleged operation without a license led to any 22 manufacturing defect. Thus, De La Paz has failed to allege that the irregularities identified in 23 the Form 483s led to a breach of any parallel state law duties that could escape implied 24 preemption. Buckman, 531 U.S. 341, 349 n.4; see also Cornwell v. Stryker Corp., 10-00066, 25 2010 WL 4641112, at *4 (D. Idaho Nov. 1, 2010) (Judge Edward J. Lodge) (dismissing claim 26 based solely on allegation that device was “adulterated” as impliedly preempted). 27 28 De La Paz’s claims also fail because she offers only conclusory allegations that the alleged irregularities caused her injuries. Specifically, she alleges, “[a]s a direct and proximate 12 1 result of one or more of these wrongful acts or omissions of the Defendants, Plaintiff suffered 2 profound injuries, required medical treatment, and incurred and continues to incur medical and 3 hospital expenses” (Amd. Compl. ¶¶ 117, 152). That conclusory allegation is not entitled to the 4 presumption of truth on a motion to dismiss. Ashcroft v. Iqbal, 556 U.S. 662, 681 (2009). De 5 La Paz’s failure to allege a causal link between any adulteration of Bayer’s Essure device and 6 her injuries is fatal to her manufacturing-defect claims. Soule v. Gen. Motors Corp., 8 Cal. 4th 7 548, 573 (1994). Thus, her first and fifth claims (to the extent the latter relates to 8 manufacturing defects) are hereby DISMISSED. 9 In her opposition to Bayer’s motion to dismiss, De La Paz states that she is prepared to amend her complaint to add “allegations regarding specific regulations related to manufacturing 11 For the Northern District of California United States District Court 10 that [Bayer] violated” as well as allegations that Bayer’s “deviation from the FDA-approved 12 plan and specifications was the cause of [her] injur[ies]” (Pl.’s Opp. at 10–11). De La Paz may 13 seek leave to amend her manufacturing-defect claims for those purposes. 14 3. DESIGN-DEFECT CLAIMS. 15 De La Paz concedes that her design-defect claims cannot survive preemption, inasmuch 16 as she cannot allege that Bayer departed from the design for Essure approved by the FDA (Pl.’s 17 Supp. Brief at 5). Indeed, her design-defect claims suffer from the same preemption and 18 causation issues as her manufacturing-defect claims. Accordingly, her second and fifth claims 19 (to the extent the latter relates to design defects) are DISMISSED. De La Paz may not seek leave 20 to amend as to those claims. 21 4. NEGLIGENT-TRAINING CLAIM. 22 California law recognizes that “if a manufacturer undertakes to train physicians and fails 23 to exercise reasonable care in that undertaking, it may be held liable for harm caused to” the 24 patient. Scott v. C.R. Bard, Inc., 231 Cal. App. 4th 763, 774 (2014). De La Paz concedes that 25 her claim for negligence in training physicians “could have been better developed” (Pl.’s Opp. 26 at 12). In fact, although the complaint briefly refers to Bayer’s training procedure, De La Paz’s 27 negligence claim (claim three) does not mention training — this proposed claim appears only in 28 her brief (Amd. Compl. ¶¶ 128–131). De La Paz seeks leave to specifically allege that Bayer 13 1 negligently trained her physician in the use of hysteroscopic equipment during the implanting 2 procedure. Bayer argues that such an amendment would be futile, inasmuch as it would be 3 expressly preempted. This order addresses Bayer’s argument to the extent possible on these 4 pleadings.4 Bayer specifically argues that the FDA reviewed and approved its training manual for 5 she alleges Bayer deviated from those materials (which she has not) (Defs.’ Request for Judicial 8 Notice, Exh. D; Defs.’ Supp. Request for Judicial Notice, Exh. E). The only decision that has 9 considered a failure-to-train claim in this context held that claim survived preemption only to 10 the extent the manufacturer failed to provide the training required by the premarket approval 11 For the Northern District of California the procedure to implant Essure, so De La Paz cannot state a claim for negligent training unless 7 United States District Court 6 process. Chao v. Smith & Nephew, Inc., No. 13-0114, 2013 WL 6157587, at *4 (S.D. Cal. Oct. 12 22, 2013) (Judge Marilyn L. Huff). 13 Here, De La Paz has not alleged that Bayer ever deviated from the approved training as 14 to Essure; however, she alleges that Bayer also trained physicians in the use of hysteroscopic 15 equipment, which equipment was never part of the premarket approval procedure for Essure. 16 Indeed, she alleges that Bayer’s website warned physicians, “[i]n order to be trained in Essure 17 you must be a skilled operative hysteroscopist” (Amd. Compl. ¶¶ 50–70, 84–86, 91(j)). Bayer’s 18 training materials did not include a training manual for hysteroscopic equipment, the materials 19 approved by the FDA only mentioned hysteroscopes in passing as equipment necessary for the 20 Essure implant procedure.5 De La Paz may seek leave to amend her complaint to include a claim for negligent 21 22 training to the extent the claim relates to training physicians to use hysteroscopic equipment or 23 to the extent it alleges that Bayer deviated from the training materials for Essure approved by 24 25 4 26 27 28 As pled, claim three alleges that Bayer acted negligently by failing to adequately test and analyze data relating to Essure, which requirements are part of the premarket approval procedure. De La Paz has made no attempt to rescue that aspect of claim three from preemption. Nor could she, inasmuch as the FDA approved Essure notwithstanding the alleged negligence. 5 Judicial notice of the training materials approved by the FDA is appropriate inasmuch as they are matters of public record and appear on the FDA’s website. 14 1 the FDA. The proposed claim must also plausibly allege a causal link between any alleged 2 negligence in training and De La Paz’s injuries. 3 5. FAILURE-TO-WARN-THE-FDA CLAIM. 4 De La Paz’s fourth claim is for failure to warn the FDA of adverse events, and her fifth manufacturers to report any time its device “may have caused or contributed to a death or 7 serious injury . . . .” 21 C.F.R. 803.50(a). As stated, our court of appeals has recognized that a 8 claim based on the failure to warn the FDA of adverse events is not preempted to the extent 9 state tort law recognizes a parallel duty (although a claim based on a failure to warn physicians 10 or patients of adverse events would be preempted). Stengel, 704 F.3d at 1234. California law 11 For the Northern District of California claim is for strict liability for, inter alia, failure to warn. The FDA requires device 6 United States District Court 5 recognizes such a duty. Coleman, 223 Cal. App. 4th at 429. To state a failure-to-warn claim 12 under California law, De La Paz “will ultimately have to prove that if [Bayer] had properly 13 reported the adverse events to the FDA as required under federal law, that information would 14 have reached [her] doctors in time to prevent [her] injuries.” Id. at 429–30 (quoting Stengel, 15 704 F.3d at 1234). 16 Here, De La Paz alleges that Bayer failed to report eight incidents of perforations of 17 patients’ fallopian tubes caused by Essure to the FDA, thereby breaching the state law duty to 18 warn the FDA (Amd. Compl. ¶ 44(c)). De La Paz alleges that if she had known of these 19 adverse events, “she never would have had Essure implanted” (Amd. Compl. ¶ 18). 20 Nevertheless, she has pled no facts that plausibly indicate that she or her physician would have 21 become aware of these adverse events if Bayer had timely reported them to the FDA. 22 In fact, the FDA already required Bayer to warn physicians and patients about the 23 possibility of perforations. Moreover, although the Form 483 did not indicate when the 24 unreported perforations occurred, it did establish that the FDA became aware of these adverse 25 events more than a year before De La Paz underwent the procedure and informed Bayer of its 26 failure to properly report those events (Defs.’ Supp. Request for Judicial Notice, Exh. C at 1; 27 Amd. Compl. ¶ 44(c)). The FDA did not require Bayer to take any action to further warn 28 physicians or patients of the possibility of perforations, beyond the warnings already in place. 15 1 Thus, De La Paz has failed to plausibly show that her injuries would have been 2 prevented if Bayer had properly reported the perforation events — a necessary element of her 3 failure-to-warn-the-FDA claim. Coleman, 223 Cal. App. 4th at 429–30. Accordingly, claims 4 four and five must be DISMISSED. De La Paz may seek leave to amend to allege facts plausibly 5 showing that if Bayer had timely reported the perforations, the FDA would have required some 6 enhancement to the perforations warning already in place, which would have caused De La Paz 7 to forego the Essure procedure. 8 6. 9 De La Paz’s sixth claim is for breach of the implied warranty of merchantability, and her seventh claim is for breach of several express warranties. 11 For the Northern District of California United States District Court 10 WARRANTY CLAIMS. A breach of the implied warranty of merchantability occurs if the product lacks “even 12 the most basic degree of fitness for ordinary use.” Mocek v. Alfa Leisure, Inc., 114 Cal. App. 13 4th 402, 406 (2003) (citing Cal. Comm. Code § 2314(2)). De La Paz’s claim for breach of the 14 implied warranty of merchantability is preempted. A determination of whether the Essure 15 device is fit for ordinary use bears directly on its safety and effectiveness. De La Paz’s failure 16 to plead parallel federal and state law violations with regard to manufacturing defects is 17 similarly fatal to her implied warranty claim. Thus, her sixth claim fails and is hereby 18 DISMISSED. 19 To state a claim for breach of an express warranty, De La Paz must allege: (1) Bayer 20 made an “affirmation of fact or promise” or a “description” of Essure, (2) the statement was 21 “part of the basis of the bargain,” and (3) that warranty was breached. Weinstat v. Dentsply 22 International, Inc., 180 Cal. App. 4th 1213, 1227 (2010) (citing Cal. Comm. Code § 23 2313(1)(a)). As stated, the only claims for breach of the express warranty that have survived 24 preemption are those that went “beyond” statements approved by the FDA. Suckow, 971 F. 25 Supp. 2d at 1049. The only such claims that have been adequately pled are those based on the 26 promotion of off-label uses of a device, which uses have not been approved by the FDA. E.g., 27 Ramirez, 961 F. Supp. 2d at 990. 28 16 1 Here, De La Paz identifies a laundry list of “warranties” that Bayer made on its website, 2 in advertisements, on fact sheets, on statements by agents, in brochures, in their SEC filings, 3 and in various statements to the FDA (Amd. Compl. ¶¶ 91–105). These statements averred that 4 Essure had “zero pregnancies” in clinical trials, that Essure was “worry free,” “surgery free,” 5 and “anesthesia free,” and that “correct placement . . . is easily performed,” among other similar 6 claims. With one exception, each of De La Paz’s examples is a statement that has been 7 approved, or even required, by the FDA as a descriptor for Essure (Defs.’ Request for Judicial 8 Notice, Exh. G; Defs.’ Supp. Request for Judicial Notice, Exh. E). Any claim for breach of 9 express warranty based on those statements would require a determination that Essure did not 11 For the Northern District of California United States District Court 10 conform to the descriptions approved by the FDA. Such claims are preempted. The sole exception is that De La Paz alleges she read a blog published by Bayer and 12 purportedly written by a user of Essure named “Judy.” The blog was in fact written by a 13 woman named Debbie Donovan, who had never used the device. De La Paz submitted 14 questions to “Judy” about the Essure device, which Judy answered in her blog posts (Amd. 15 Compl. ¶ 97). 16 There is no indication that the FDA approved the “Judy” blog, so a claim based on that 17 blog could plausibly survive preemption. Nevertheless, De La Paz has failed to include any 18 allegations of the contents of the blog. The only “fact” about the blog she has alleged is that it 19 was ghost-written, which is not a “promise” or a “description” of the Essure product, so failure 20 to conform with some warranty that “Judy” was real cannot give rise to a claim with regard to 21 Essure. There is also no indication that the Essure device failed to conform to the statements 22 made by “Judy,” such that the blog’s contents could form the basis of a claim for breach of 23 express warranty. 24 De La Paz has failed to plead facts that plausibly indicate that Bayer breached a 25 warranty made beyond statements approved by the FDA. Accordingly, her seventh claim is 26 hereby DISMISSED. De La Paz may seek leave to amend her sixth and seventh claims to allege 27 breaches of warranties made beyond the scope of the FDA’s premarket approval and to allege 28 17 1 the specific contents of the “Judy” blog, which may have set forth express warranties about the 2 Essure product. 3 7. 4 De La Paz’s eighth claim is for negligent misrepresentation, her ninth claim is for MISREPRESENTATION AND FRAUD CLAIMS. 5 fraudulent misrepresentation, and her tenth claim is for fraud by concealment. The 6 misrepresentation claims are based on the same statements that form the basis of De La Paz’s 7 claim for breach of express warranties, and they are preempted for the same reasons as that 8 claim (namely, the statements conformed to statements approved by the FDA), with the 9 exception of the “Judy” blog (which, as discussed below, is inadequately pled under Rule 9(b)). De La Paz’s tenth claim, for fraud by concealment, is based on the same allegations as 11 For the Northern District of California United States District Court 10 her failure-to-warn-the-FDA claim and is preempted for the same reason — there is no causal 12 link between Bayer’s alleged concealment of facts from the FDA and De La Paz’s injury. 13 Moreover, each of De La Paz’s eighth through tenth claims include reliance as an 14 element. Lazar v. Superior Court, 12 Cal. 4th 631, 638 (1996). De La Paz has failed to allege 15 that she ever encountered, much less relied on, any statements or omissions made by Bayer in 16 electing to undergo the Essure procedure, with the exception of the “Judy” blog. As to the 17 “Judy” blog (as well as the other allegedly fraudulent statements identified in the complaint), 18 De La Paz’s fraud and negligent misrepresentation claims based thereon fail to meet the 19 heightened pleading standard for Rule 9(b).6 Pursuant to Rule 9(b), a plaintiff’s allegations for any claims sounding in fraud require a 20 21 particularized statement of “the who, what, when, where, and how of the misconduct charged.” 22 Kearns v. Ford Motor Co., 567 F.3d 1120, 1124 (9th Cir. 2009). Here, De La Paz has offered 23 only bare descriptions of Bayer’s statements. She has failed to offer particularized details, such 24 as when (if ever) she encountered the alleged misrepresentations and how she came to rely on 25 them. She has failed to allege how she came under the impression that “Judy” was a real 26 patient, rather than ghost-written. De La Paz’s bare descriptions of statements made by Bayer, 27 6 28 The undersigned has previously held, in accord with the prevailing trend among district courts in this circuit, that Rule 9(b) applies to negligent misrepresentation. Nasseri v. Wells Fargo Bank, N.A., No. 15-04001, 2015 WL 7429447, at *6 (N.D. Cal. Nov. 23, 2015). 18 1 without any further details of how she encountered them or relied on them, fall far short of the 2 particularity required by Rule 9(b). 3 Accordingly, De La Paz’s eighth through tenth claims are hereby DISMISSED. De La 4 Paz may seek leave to amend her claims to allege a basis for reliance on Bayer’s statements, as 5 well as the more particularized facts required by Rule 9(b). 6 8. STATUTE OF LIMITATIONS. 7 As stated, each of De La Paz’s claims is dismissed, although she may seek leave to claims would remain precluded by California’s two-year statute of limitations on personal- 10 injury actions, inasmuch as De La Paz knew about the link between her symptoms and the 11 For the Northern District of California amend. Bayer contends that even if De La Paz can overcome the defects addressed above, her 9 United States District Court 8 Essure device since 2012 when the broken coil in her right fallopian tube required a follow-up 12 surgery, three years before she commenced the action. De La Paz responds that her claim did 13 not accrue until 2014, because she had no reason to know of the link between the alleged 14 defects in the Essure device in her left fallopian tube and her symptoms after her surgery to 15 remove her right fallopian tube. Alternatively, De La Paz contends she is entitled to tolling on 16 the basis of fraudulent concealment. This order addresses these arguments to the extent 17 possible with these defective pleadings. 18 Under the delayed-discovery rule, California law postpones the accrual of a claim “until 19 the plaintiff discovers, or has reason to discover” the essential elements of that claim. Fox v. 20 Ethicon Endo-Surgery, Inc., 35 Cal. 4th 797, 807 (2005). The question of when accrual 21 occurred under the delayed-discovery rule is generally “a question of fact unless the evidence 22 can support only one reasonable conclusion.” Ovando v. County of Los Angeles, 159 Cal. App. 23 4th 42, 61 (2008) (citations omitted). 24 Here, De La Paz alleges she became aware of the injuries that give rise to these claims 25 (i.e., those in her left fallopian tube) in 2014 when she read about other women who had Essure 26 implanted experiencing similar symptoms. Bayer responds that De La Paz should have become 27 aware of her injuries when she discovered that her symptoms had not subsided after the removal 28 of her right fallopian tube in 2012. 19 It is possible that De La Paz could have intuited, when she continued to have some of 1 2 the same symptoms, that the cause of those symptoms was the remaining coil, however, that is 3 not the only reasonable conclusion. Ibid. Rather, on these pleadings it is also reasonable to 4 conclude that De La Paz would attribute her symptoms to some other cause, given that the coil 5 in her left fallopian tube remained intact, and she had been assured her symptoms would 6 subside following removal. Bayer’s citation to Pooshs v. Philip Morris USA, Inc., 51 Cal. 4th 788, 797 (2011), is 7 wrongful cause but is uncertain as to how serious the resulting damages will be or whether 10 additional injuries will later become manifest[,] . . . the infliction of appreciable and actual 11 For the Northern District of California inapposite. That decision held that “where a plaintiff is aware of both an injury and its 9 United States District Court 8 harm, however uncertain in amount, will commence the statutory period.” Here, the issue is not 12 that De La Paz waited to see whether additional injuries would manifest from the cause of 13 which she was already aware. She alleges that her new injuries resulted from a separate cause, 14 namely alleged defects relating to the device that remained implanted in the left fallopian tube, 15 rather than the broken coil in the right fallopian tube. De La Paz has adequately alleged that her claims, such as they are, accrued within the 16 17 limitations period pursuant to the delayed-discovery rule. Accordingly, Bayer’s statute-of- 18 limitations argument does not foreclose the possibility that De La Paz may amend her complaint 19 to allege a viable claim. This is without prejudice to a renewed argument in response to any 20 motion for leave to amend.7 CONCLUSION 21 For the reasons stated above, Bayer’s motion to dismiss is GRANTED. To the extent 22 23 stated above, plaintiff may seek leave to amend her complaint and shall have FOURTEEN 24 CALENDAR DAYS from 25 track, for leave to file an amended complaint. A proposed amended complaint must be 26 appended to the motion, and plaintiff must plead her best case. The motion should clearly the date of this order to file a motion, noticed on the normal 35-day 27 7 28 De La Paz’s argument that she is entitled to tolling based on fraudulent concealment of the alleged defects cannot be meaningfully addressed on these pleadings, inasmuch as she has neither alleged a cause of her injuries nor reliance on any fraudulent statement. 20 1 explain how the amendments to the complaint cure the deficiencies identified herein, as well as 2 any others raised in defendants’ briefs. If such a motion is not filed by the deadline, the case 3 will be closed. 4 Bayer has requested judicial notice of various documents submitted during the FDA 5 premarket approval process and public statements regarding Essure. With the exception of the 6 documents cited above, those documents were not necessary to this order, and Bayer’s request 7 is therefore DENIED AS MOOT. 8 9 IT IS SO ORDERED. 11 For the Northern District of California United States District Court 10 Dated: February 2, 2016. WILLIAM ALSUP UNITED STATES DISTRICT JUDGE 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 21
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