Pablos et al v. Bayer Corporation et al

MOTION to Dismiss Case

D. Ariz.July 3, 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 101784062_1 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 Lewis Roca Rothgerber Christie LLP Sidley Austin LLP 201 East Washington Street, Suite 1200 1501 K. Street, N.W. Phoenix, AZ 85004-2595 Washington, D.C., 20005 Foster Robberson (State Bar No. 005939) Jonathan F. Cohn (pro hac vice application pending) Direct Dial: 602.262.5795 Direct Dial: 202.736.8110 Direct Fax: 602.734.3856 jfcohn@sidley.com Email: frobberson@lrrc.com Jared L. Sutton (State Bar No. 028887) Direct Dial: 602.262.0259 Direct Fax: 602.734.3924 Email: jsutton@lrrc.com Attorneys for Defendants UNITED STATES DISTRICT COURT DISTRICT OF ARIZONA Stacy Pablos and Danny Pablos, Plaintiffs, vs. Bayer Corporation, et al., Defendants. No. 2:17-cv-00863-DJH DEFENDANTS’ MOTION TO DISMISS (JURY TRIAL DEMANDED) Plaintiffs’ Complaint should be dismissed. Numerous district courts have rejected virtually identical claims because they are preempted by federal law and do not meet federal pleading standards. See, e.g., Burrell v. Bayer Corp., No. 1:17-CV- 00031, 2017 WL 1955333 (W.D.N.C. May 10, 2017) (dismissing with prejudice all claims against Bayer); Norman v. Bayer Corp., No. 3:16-cv-00253 (JAM), 2016 WL 4007547 (D. Conn. July 26, 2016) (same); De La Paz v. Bayer Healthcare LLC, 159 F. Supp. 3d 1085 (N.D. Cal. 2016) (dismissing all claims with leave to amend certain claims, after which plaintiff voluntarily dismissed case); Richardson v. Bayer HealthCare Pharms. Inc., No. 4:15-cv-00443, 2016 WL 4546369 (D. Idaho Aug. 30, 2016) (dismissing almost all claims, after which plaintiff voluntarily dismissed case); McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804, 838-39 (E.D. Pa. 2016) (dismissing almost all claims).1 1 Plaintiffs have fared no better in state courts. See Medali v. Bayer HealthCare LLC, No. RG15771555 (Cal. Super Feb. 16, 2016) (demurrer sustained with leave to amend certain claims) (order attached as Exhibit A to concurrently filed Request for Judicial Notice (“RJN”) at Doc. 17); Noris v. Bayer Essure, Inc., No. BC589882, (Cal. Super. Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 1 of 19 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 101784062_1 2 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 These courts have had no trouble dismissing the claims at issue because, at bottom, Plaintiffs are attempting to second-guess the U.S. Food & Drug Administration (“FDA”). See Riegel v. Medtronic, Inc., 552 U.S. 312, 321-22 (2008); Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353 (2001); In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204-08 (8th Cir. 2010); see also 21 U.S.C. §§ 360k(a), 337(a). FDA has the exclusive authority to regulate Class III medical devices like Essure, and has decided—numerous times—that Essure is safe and effective. FDA has balanced the benefits and risks of the device and recently confirmed that “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.” FDA News Release, (RJN Ex. F). The Court should dismiss Plaintiffs’ efforts to second-guess FDA’s decision. I. BACKGROUND A. Statutory and Regulatory Background Congress has spoken. The Medical Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”) grant FDA exclusive authority to regulate medical devices and create a comprehensive statutory “regime of detailed federal oversight.” Riegel, 552 U.S. at 316. To alleviate the “undu[e] burden[]” of differing state regulation, Congress adopted a “general prohibition on non-Federal regulation” of medical devices by incorporating an express-preemption clause into the MDA. H.R. Rep. No. 94–853, at 45 (1976); Brooks v. Howmedica, Inc., 273 F.3d 785, 797 (8th Cir. 2001) (explicit goal of MDA was “national uniformity in product regulation”). Accordingly, no state may 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). Apr. 26, 2016) (same) (transcript excerpts attached as RJN Ex. B); Williams v. Bayer Corp., No. 15BA-CV02526 (Mo. Cir. July 18, 2016) (complaint dismissed with prejudice) (RJN Ex. C); Lance v. Bayer Essure Inc., RG16809860 (Cal. Super. Aug. 2, 2016) (RJN Ex. D) (demurrer sustained in part); Journey v. Bayer Corp., RG16810409 (Cal. Super. Apr. 12, 2017) (RJN Ex. E) (demurrer sustained without leave to amend on training and manufacturing claims). Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 2 of 19 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 101784062_1 3 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 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 “presents a potential unreasonable risk of illness or injury” is deemed a Class III device. 21 U.S.C. §§ 360c(a)(1)(C)(i)-(ii). FDA subjects a small percentage of Class III devices, such as Essure, to the most “rigorous” level of scrutiny. These devices must receive Premarket Approval (“PMA”) before they can be marketed or sold. Riegel, 552 U.S. at 318; Buckman, 531 U.S. at 344. 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)). A “manufacturer must furnish” to FDA “detailed information about the device’s testing, design, components, performance standards, manufacturing, packaging, and labeling.” Yale-New Haven, 470 F.3d at 74. FDA then “‘weigh[s] 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. (citing 21 U.S.C. §§ 360c(a)(2)(B), 360e(d)(1)(A)). After a device is approved, a manufacturer cannot change the label 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 Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 3 of 19 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 101784062_1 4 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id. (citing 21 U.S.C. § 360e(d)(6)(A)(i)). FDA may demand additional information from the manufacturer at any time, see 21 U.S.C. § 360e(c)(1)(H), and may require revisions to any component of the application, see 21 C.F.R. § 814.44(c). Only upon successfully “running the gauntlet of the PMA process,” Medtronic, Inc. v. Lohr, 518 U.S. 470, 494 (1996), may a Class III device lawfully be marketed in the United States. Furthermore, 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) (Gorsuch, J.). 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, 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. Id. at 349; see also 21 U.S.C. §§ 332, 333, 334. B. Factual Background FDA has long recognized that Essure is a safe and effective method of permanent female contraception. Essure consists of two “micro-inserts” that are placed in a patient’s fallopian tubes by her doctor. In 2002, FDA granted Essure PMA as a Class III device, and FDA has never withdrawn or suspended that PMA. See FDA, PMA Order for the Essure System (“PMA Order”) (RJN, Ex. G at 4); Summary of Safety and Effectiveness Data for Essure System (RJN Ex. H); FDA, Essure System PMA Supplements (RJN Ex. I); FDA, Essure “Regulatory History” (RJN Ex. J). Rather, FDA granted numerous supplemental approvals, as recently as November 2016. FDA, PMA Supplements (RJN Ex. I). FDA repeatedly has reviewed and approved Essure’s design, construction, manufacturing, testing, training requirements, warnings, instructions for use, patient information, and all other labeling. FDA, PMA Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 4 of 19 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 101784062_1 5 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 Order (RJN Ex. G at 4); Summary of Safety and Effectiveness Data for Essure System (RJN Ex. H); Professional Labeling (2002) (“2002 IFU”) (RJN, Ex. K); Health Care Provider Instructions for Use (2013) (“2013 IFU”) (RJN, Ex. L); ESS305 Post- Approval Study: 12 month interim report (RJN, Ex. M). In fact, FDA recently rejected challenges to the device, reconfirming the “FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.” FDA News Release (Feb. 29, 2016) (RJN, Ex. F). Plaintiffs, husband-and-wife residents of Georgia, allege Mrs. Pablos received Essure from her doctor in Glendale, Arizona, in March 2012 and later experienced pain on her left side and underwent a hysterectomy. (Doc. 1 at 38 ¶¶ 90-92.) II. STANDARD OF REVIEW A claim should be dismissed if a plaintiff fails 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” or “naked assertions” devoid of “further factual enhancement.” Id. at 545, 570. III. ARGUMENT Plaintiffs’ claims are preempted by federal law, and fail to meet federal pleading standards. Numerous courts have rejected nearly identical claims, see supra at 1, and this Court should do the same, see In re Medtronic, 623 F.3d at 1205-08. A. Plaintiffs’ claims are preempted. Plaintiffs’ claims are preempted, as other courts have held in dismissing highly similar claims related to Essure. See, e.g., Burrell, 2017 WL 1955333; Norman, 2016 WL 4007547, at *5-6; De La Paz, 159 F. Supp. 3d at 1100; see also Richardson, 2016 WL 4546369, at *9; McLaughlin, 172 F. Supp. 3d at 838-39. Federal law expressly preempts any state-law claim against a medical device manufacturer that would impose safety or effectiveness requirements on a Class III medical device “different from, or in addition to, any requirement” imposed by FDA through the PMA process. 21 U.S.C. Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 5 of 19 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 101784062_1 6 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 § 360k(a)(1); Riegel, 552 U.S. at 321; In re Medtronic, 623 F.3d at 1204. Additionally, because the MDA provides that all actions to enforce FDA requirements “shall be by and in the name of the United States,” 21 U.S.C. § 337(a), suits by private parties “for noncompliance with the medical device provisions” are impliedly preempted. Buckman, 531 U.S. at 349 n.4; In re Medtronic, 623 F.3d at 1204. This leaves only a “narrow gap” between express and implied preemption: “The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).” Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013) (internal quotation omitted). Plaintiffs’ claims do not fall within this “narrow gap,” and are therefore preempted. Plaintiffs’ causes of action raise four basic theories of liability: (1) Essure is defectively designed; (2) Bayer made misrepresentations concerning Essure; (3) Bayer inadequately warned of the risks of Essure; and (4) Essure devices were defectively manufactured. All four theories are foreclosed by preemption precedent. 1. Plaintiffs’ design defect claim is preempted. Plaintiffs allege Essure was defectively designed and unreasonably dangerous. (See, e.g., Doc. 1, at 52 ¶ 135.) As De La Paz explained, Essure design-defect claims “cannot survive preemption.” 159 F. Supp. 3d at 1095. FDA specficially approved the design of Essure, and found that the design is safe and effective. FDA has repeatedly reaffirmed this judgment, including in its recent statement that it “believes Essure remains an appropriate option.” (RJN, Ex. F). Accordingly, any tort claim challenging Essure’s design would impose “different” or “addition[al]” requirements on the device, and is preempted. 21 U.S.C. § 360k(a)(1); Riegel, 552 U.S. at 321. The label of the claim is irrelevant; plaintiffs cannot escape preemption by merely “dressing up” their claims. Dishman v. UNUM Life Ins. Co. of Am., 269 F.3d 974, 983 (9th Cir. 2001). The claim is preempted regardless of whether it is characterized as a design defect, a breach of implied warranty, negligence per se, or Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 6 of 19 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 101784062_1 7 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 otherwise. See De La Paz, 159 F. Supp. 3d at 1097 (holding implied warranty claim preempted because “[a] determination of whether the Essure device is fit for ordinary use bears directly on its safety and effectiveness,” as found by FDA). 2. Plaintiffs’ misrepresentation claim is preempted. Plaintiffs also claim Bayer misrepresented Essure’s safety and effectiveness in marketing, advertising, and promotions. See Doc. 1 at 56-58, ¶¶ 151-66.2 As other courts have held regarding similar allegations, see, e.g., De La Paz, 159 F. Supp. 3d at 1097-99; Norman, 2016 WL 4007547, at *3-6, these claims are preempted because FDA approved language substantively identical to the alleged misrepresentations: Alleged Misrepresentation Labeling Statement Approved by FDA • “zero pregnancies in the clinical trials.” (Doc. 1 at 16 ¶ 31(a).) • “In the original Essure clinical studies, zero (0) pregnancies were reported in women who had the Essure inserts for up to 5 years.” Patient Info. Booklet (“PIB”) 2015 (RJN Ex. N at 12). • Essure is “worry free” and “simple procedure performed in you doctor’s office” in “less than 10 minutes,” “requires no downtime for recovery,” and “eliminates the risks, discomfort, and recovery time associated with surgical procedures.” (Doc. 1 at 17 ¶ 31(c).) • “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,” “Can be done in your doctor’s office,” and “Does not require surgery or exposure to its potential risks.” PIB 2015 (RJN Ex. N at 4). • The “benefits of Essure,” include that it is “Non-Surgical,” and that “most women return to normal activity within one to two days.” Id. at 5. • “The entire process usually takes less than ten minutes.” Id. at 9. • “[T]he Essure inserts stay secure, forming a long protective barrier against pregnancy. They also remain visible outside your tubes, so your doctor can confirm that they’re properly in place.” • “Over the next 3 months, your body will form . . . a natural barrier within the fallopian tubes” that “prevents sperm from reaching the eggs.” PIB 2015 (RJN Ex. N at 6). • “An Essure Confirmation Test will verify that the inserts are placed correctly so that you can 2 Plaintiffs’ negligent misrepresentation claim and their negligence per se claim are both based in whole or in part on these allegations. (See Doc. 1 at 47 ¶ 131.) Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 7 of 19 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 101784062_1 8 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 (Doc. 1 at 18 ¶ 31(d).) rely on Essure for birth control.” Id. at 5. • “[T]he Essure inserts are made from the same trusted, silicone free material used in heart stents.” (Doc. 1 at 18 ¶ 31(e).) • “These same materials have been used for many years in cardiac stents and other medical devices placed in other parts of the body.” PIB 2015 (RJN Ex. N at 11). • “Essure is the most effective permanent birth control available- even more effective than tying your tubes or a vasectomy.” (Doc. 1 at 19 ¶ 31(g).) • Essure is “99.83% effective.” PIB 2015 (RJN Ex. N at 5, 10, 12). • Comparison of vasectomy, tubal ligation, and other methods of permanent and non- permanent contraception, each listing a higher rate of failure than Essure. Id. at 15-19. • “[C]orrect placement . . . is performed easily because of the design of the microinsert.” (Doc. 1 at 19 ¶ 31(h).) • “Essure is a simple procedure . . . .” PIB 2015 (RJN Ex. N at 5). • “The inserts are soft and flexible, and are delivered with a tube through your vagina and cervix, and into your fallopian tubes. No incisions are needed.” Id. at 6. • “An Essure trained doctor inserts spring-like coils, called micro-inserts” and “[p]hysicians must be signed-off to perform Essure procedure.” (Doc. 1 at 20 ¶ 33(a).) • “In order to be trained in Essure you must be a skilled operative hysteroscopist. You will find the procedure easier to learn if you are already proficient in operative hysteroscopy and management of the awake patient. If your skills are minimal or out of date, you should attend a hysteroscopy course before learning Essure.” (Doc. 1 at 20-21 ¶ 33(b).) • “The insert is a dynamic and flexible spring- like device.” 2013 IFU (RJN Ex. L at 1). • “This device should only be used by physicians who are knowledgeable hysteroscopists, have read and understood the information in this Instructions for Use and in the Physician Training Manual, and have successfully completed the Essure Training program. Completion of the Essure training program includes preceptoring in Essure placement until competency is established...” 2002 IFU (RJN Ex. K at 1); see also 2013 IFU (RJN Ex. L at 1) (similar). • “The PET fibers are what caused the tissue growth” and Essure “works with your body to create a natural barrier • “It is believed that the tissue in-growth into the device caused by the PET fibers results in both device retention and pregnancy prevention.” 2002 IFU (RJN Ex. K at 4). Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 8 of 19 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 101784062_1 9 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 against pregnancy.” (Doc. 1 at 19-20 ¶ 31(i).) • “PET fiber causes tissue in-growth into and around the insert, facilitating insert retention and pregnancy prevention.” 2013 IFU (RJN Ex. L at 1). • “Essure is a permanent birth control procedure that works with your body to create a natural barrier against pregnancy.” PIB 2015 (RJN Ex. N at 4). As numerous courts have recognized, claims that target “marketing that complied with the FDA-approved requirements” must be dismissed “because success on [such a] claim[] requires a showing that the FDA requirements themselves were deficient.” Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919, 933 (5th Cir. 2006); accord McLaughlin, 2017 WL 697047, at *12-15 (dismissing claims related to Essure for fraudulent misrepresentation because they were “completely consistent with statements in FDA-approved materials and do not undermine—or overstate—the approved and/or required statements in those materials”); Norman, 2016 WL 4007547, at *5-6 (dismissing claims related to Essure for breach of warranty and negligent misrepresentation because the claims were “so similar to the approved language as to be substantively the same”); De La Paz, 159 F. Supp. 3d at 1098 (dismissing claims related to Essure for “negligent misrepresentation” because “the statements conformed to statements approved by the FDA”); Burrell, 2017 WL 1955333, at *7 (same); Pinsonneault v. St. Jude Med., Inc., 953 F. Supp. 2d 1006, 1019 (D. Minn. 2013) (“[T]o that 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….”). Further, the claims are preempted because the Complaint does not plausibly allege that any asserted federal violation caused each Plaintiff’s injuries. See, e.g., Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 282 (E.D.N.Y. 2009) (dismissing state law claims as expressly preempted because “to survive preemption under the MDA a plaintiff must demonstrate a cognizable link between the defendant’s federal violations Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 9 of 19 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 101784062_1 10 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 and the plaintiff’s injury”). As in Burrell, Norman, and De La Paz, Plaintiffs simply assert a laundry list of alleged misrepresentations without describing a “causal link” between any federal requirement and their injury. See De La Paz 159 F. Supp. at 1099; Norman, 2016 WL 4007547, at *5; Burrell, 2017 WL 1955333, at *6. Plaintiffs have “failed to allege that [they] ever encountered, much less relied on” any of the specific alleged misrepresentations “made by Bayer in electing to undergo the Essure procedure.” De La Paz, 159 F. Supp. at 1099. Plaintiffs make only conclusory allegations that they “relied on the[] misrepresentations by Defendants,” with no allegations as to which of the multitude of supposed misrepresentations Plaintiffs actually read, and how they influenced Plaintiffs’ decisions. (E.g., Doc. 1 at 20 ¶ 32.) 3. Plaintiffs’ failure to warn claims are preempted. Plaintiffs’ claims alleging failure to warn are likewise preempted.3 Plaintiffs “d[o] not allege that [Bayer] modified or failed to include FDA-approved warnings.” Medtronic, 623 F.3d at 1205. Instead, they (1) challenge the FDA-approved labeling as false, misleading, and inadequate, and (2) allege Bayer did not properly report to FDA. Neither claim falls within the “gap” between express and implied preemption. a. Claims challenging the adequacy of FDA-approved warnings are expressly preempted. Plaintiffs repeatedly allege the FDA-approved warnings are “inadequate.” (See, e.g., Doc. 1 at 12 ¶ 21, 44 ¶ 113-14.) But federal law squarely preempts any claim that Bayer “was required to give additional warnings” beyond what FDA approved. Medtronic, 623 F.3d at 1205. Such a direct attack on the FDA-approved label is “precisely the type of state requirement that is ‘different from or in addition to’ the federal requirement and therefore preempted.” Id., 623 F.3d at 1205 (quoting Riegel, 552 U.S. at 330); see also Arthur v. Medtronic, Inc., 2014 WL 3894365, at *6 (E.D. Mo. Aug. 11, 2014) (failure to warn claims “alleging that defendants failed to provide 3 Plaintiffs’ negligence per se claim is also based on allegations that Bayer failed to report adverse events to the FDA. Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 10 of 19 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 101784062_1 11 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 adequate warning of the dangers of using the [Class III] device” were expressly preempted); Blankenship v. Medtronic, Inc., 6 F. Supp. 3d 979, 988-89 (E.D. Mo. 2014) (failure to warn claim that would establish different warning and labeling requirement than FDA approved was expressly preempted); Brooks, 273 F.3d at 796 (“A jury finding of negligent failure to warn would be premised on the fact that the label . . . was not written in a particular way or did not contain certain information. This would be equivalent to a state regulation imposing specific label requirements.”); Mattingly v. Medtronic, Inc., 486 F. Supp. 2d 964, 968 (E.D. Mo. 2007) (similar). Plaintiffs allege Bayer could have unilaterally provided additional warnings through the “Changes Being Effected” provision of 21 C.F.R. § 814.39(d)(2), (Doc. 1 at 11 ¶ 19, 12 ¶ 22), but these allegations do 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 re Medtronic, 623 F.3d at 1205. b. Failure- to-report claims are impliedly preempted. To the extent they are based on Bayer’s alleged failure to report adverse events or other information to FDA (Doc. 1 at 39 ¶ 97, 41 ¶ 100, 43 ¶ 111, 49 ¶ 131(d), 58 ¶ 164), Plaintiffs’ claims are impliedly preempted because Plaintiffs do not allege a “causal link” between any failure to report adverse events and their alleged injuries. See, e.g., De La Paz, 159 F. Supp. 3d at 1093, 1099; Stengel v. Medtronic, Inc., 704 F.3d 1224, 1235 (9th Cir. 2013) (Watford, J., concurring) (“Because [plaintiffs] predicate their claim on Medtronic’s reporting duty to the FDA, as they must to avoid express preemption, the [plaintiffs] face a causation hurdle that would not otherwise exist. To prevail, they will ultimately have to prove that if Medtronic had properly reported the adverse events to the FDA as required under federal law, that information would have reached plaintiff’s doctors in time to prevent his injuries.”). Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 11 of 19 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 101784062_1 12 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 Plaintiffs do not plausibly allege a “causal link” between any failure to report adverse events and their alleged injuries. See, e.g., De La Paz, 159 F. Supp. at 1093, 1099; Norman, 2016 WL 4007547, at *4 (“[P]laintiff fails to plead facts that plausibly connect defendants’ alleged reporting violations to her injuries.”). Plaintiffs do not adequately explain how reporting adverse events to FDA would have warned Plaintiff Mrs. Pablos and her physicians. See Norman, 2016 WL 4007547, at *4 (“[P]laintiff fails to plead facts that plausibly connect defendants’ alleged reporting violations to her injuries.”). Indeed, the undisputed facts are that FDA is now aware of all of these alleged adverse events and reaffirmed that “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.” FDA News Release (Feb. 29, 2016) (RJN, Ex. F). Further, as Norman and Burrell held, Plaintiffs’ attempt to invoke FDA’s recent boxed warning and Patient Decision Checklist only undermines their claims and confirms why they are preempted. Norman, 2016 WL 4007547, at *4; Burrell, 2017 WL 1955333, at *5. According to Plaintiffs’ allegations, FDA is now in possession of all of the supposedly withheld information. See, e.g., Doc. 1 at 32 ¶ 67 (alleging that FDA analyzed various complaints in connection with its 2011 inspection); id. 34 ¶¶ 71- 73.4 After holding “a public hearing discussing the risks and benefits of [Essure],” Doc. 1 at 42 ¶ 103, FDA did not require Bayer to change its disclosures on the percentage of patients who may be injured, the number of adverse events, or the rate of unintended pregnancies. Instead, FDA released 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.” FDA Guidance (RJN Ex. Q at 5-6). As Norman held, this “new type of warning did not change any of the 4 Plaintiffs’ repeated attempts to highlight the number of complaints received by Bayer relative to the number of MDRs submitted (see, e.g., Doc. 1 at 43 ¶ 111), also ignore the fact that there is no obligation blindly to report all “complaints” to the agency. See 21 C.F.R. § 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 any substantial number of these complaints were adverse events that should have been reported to FDA but were not. Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 12 of 19 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 101784062_1 13 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 warnings’ substance.” 2016 WL 4007547, at *4. Rather, “the same information was available on the prior labeling,” Burrell, 2017 WL 1955333, at *5: Essure Labeling RJN, Ex. O (2012 PIB) RJN, Ex. P (2011 IFU) Boxed Warning RJN, Ex. Q (2016 FDA 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 experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required.” (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,” it would have resulted in additional warnings to physicians is insufficient to allege causation. (E.g., Doc. 1 at 41 ¶ 102.) 4. Plaintiffs’ manufacturing defect claims are preempted. Plaintiffs’ defective manufacturing claims are similarly preempted because Plaintiffs once again seek to second-guess the FDA, which determined that Essure is safe and effective. See supra at 5; PMA Order (RJN, Ex. G at 4). If Plaintiffs allege Bayer deviated from FDA’s manufacturing requirements, making Essure “adulterated,” (Doc. 1 at 36 ¶ 83), their conclusory allegations fail for the same reasons that virtually identical allegations failed in De La Paz, Richardson, Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 13 of 19 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 101784062_1 14 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 and McLaughlin. De La Paz, 159 F. Supp. 3d at 1094-95; Richardson, 2016 WL 4546369, at *4-5; McLaughlin, 172 F. Supp. 3d at 834-36; Burrell, 2017 WL 1955333, at *6. Plaintiffs “cannot state a claim based solely on Bayer’s adulteration of certain Essure devices, since any such claim would ‘exist solely by virtue of the [MDA],’” and is impliedly preempted. De La Paz, 159 F. Supp. 3d at 1094-95 (quoting Buckman, 531 U.S. at 353); see also Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th Cir. 2013) (affirming dismissal of state-law claim as impliedly preempted because “whether the [devices] were modified so that they were ‘adulterated’ . . . rest[s] within the enforcement authority of the FDA, not this Court”); Gile v. Optical Radiation Corp., 22 F.3d 540, 544 (3d Cir. 1994) (same); Cornwell v. Stryker Corp., No. 1:10-cv-00066, 2010 WL 4641112, at *4 (D. Idaho Nov. 1, 2010) (“To the extent Plaintiff’s parallel claim is based on a theory the medical device implanted in Plaintiff was ‘adulterated’ such claim must also be dismissed as there is no private right of action for the enforcement of federal regulations relating to medical device provisions.”). Plaintiffs’ claims are also preempted because they fail to identify violations of federal requirements that produced defects in their devices and caused their injuries. “[T]o avoid preemption on a manufacturing defect claim, [a] plaintiff must allege that her device was not manufactured in conformance with the specification approved by the FDA,” Norman, 2016 WL 4007457, at *3, and that such deviation “resulted in a manufacturing defect that caused her injuries,” De La Paz, 159 F. Supp. 3d at 1094 (emphasis added). See also, e.g., McLaughlin, 2017 WL 697047, at *18; Burrell, 2017 WL 1955333, at *6 (dismissing where “plaintiff has not linked any manufacturing deficiency to the device that the plaintiff received and how it caused the alleged injuries”); Journey (RJN Ex. E at 6-9) (dismissing because connection between alleged “nonconforming materials and violations of CPMA and CGMP” and particular plaintiffs’ injuries was “entirely speculative”); Cohen v. Guidant Corp., No. CV-05- 8070, 2011 WL 637472, at *2 (C.D. Cal. Feb. 15, 2011) (claims preempted where plaintiff failed to “link[]” federal requirements “to a defect in his specific pacemaker Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 14 of 19 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 101784062_1 15 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 that was caused by Defendants violating FDA regulations”). Plaintiffs do not meet this standard. Here, as in Norman and De La Paz, Plaintiffs provide: • “no description of the ‘non-conforming material’ used in manufacturing the device, or how the use of that material caused a defect in the product itself,” De La Paz, 159 F. Supp. 3d at 1095, • no “explanation of the function of ‘pre-sterile and post-sterile cages’ in the manufacturing process,” id., • no “explanation for how Bayer’s alleged operation without a license led to any manufacturing defect,” id., • no “plausible reason to think that [their] device[s] came from [a] non- conforming batch, or that [they] suffered from any other manufacturing defect,” Norman, 2016 WL 4007457, at *3, • no “facts that would make it plausible that the complications [they] suffered . . . were due to any defect in the device,” id., • “no causal connection between the alleged mislabeling and unsanitary conditions, and Plaintiffs’ injuries,” McLaughlin, 2017 WL 697047, at *18, and • no allegations of “what material in the devices was allegedly non- conforming, or the manner in which such non-conforming material could have actually caused the device to migrate,” id. Accordingly, as in Norman, De La Paz, McLaughlin, Burrell, and Journey, Plaintiffs’ claims fail. Finally, Plaintiffs’ other conclusory assertions of manufacturing defects— including failure to comply with “general quality control standards,” “quality problems,” and other unspecified “device failures”—are also expressly preempted. See, e.g., Compl. 48 ¶ 131(c), (g), (j). A manufacturing defect claim must be based on failure to follow a “specific federal requirement in the PMA approval.” In re Medtronic, 623 F.3d at 1206. But every manufacturing “requirement” Plaintiffs identify is actually an FDA Current Good Manufacturing Practice (“CGMP”). (Doc. 1 at 28 ¶ 56 (listing provisions from 21 C.F.R. Part 820).)5 CGMPs are merely an 5 Several of the statutory and regulatory provisions Plaintiffs list in their negligence, negligence per se, and strict liability manufacturing defect claims concern alleged misrepresentations or failure to report adverse events. See, e.g., 21 U.S.C. §§ 352(a), 331(a), 352(q), 360i(a), 360(q), 360(r); 21 C.F.R. §§ 803.50, 814.80, 814.84(b)(2), 803.3, 814.39. Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 15 of 19 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 101784062_1 16 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 “umbrella quality system” providing “general objectives” for manufacturers—not “specific federal requirement[s] in the PMA approval”—and thus “do not save . . . claims from preemption.” In re Medtronic, 623 F.3d at 1206; see also Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 588 (E.D.N.Y. 2009) (CGMPs too “intentionally vague and open-ended” to save claims from preemption); Horowitz, 613 F. Supp. 2d at 284 (CGMPs “too generic” to save claims from preemption). B. Plaintiffs fail to plead a plausible claim for relief. Even if Plaintiffs’ claims are not preempted—and they are—they also should be dismissed because Plaintiffs fail 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). Further, Plaintiffs fail to plead their fraud-based claim with the requisite particularly. See Fed. R. Civ. P. 9(b).6 1. Plaintiffs fail to plead facts to show causation or reliance. Plaintiffs’ failure to allege a causal link between asserted federal violations and their injuries dooms the Complaint under Twombly and Iqbal. The Complaint impermissibly bases claims on conclusory allegations that Mrs. Pablos “relied on” on Defendant’s “omissions and/or misrepresentations” and “would not have chosen to use Essure” had she known “the true risks of Essure.” (Doc. 1 at 8 ¶ 12, 20 ¶ 32, 25 ¶ 42.) Courts routinely find that such allegations are not sufficient to allege causation in 6 As an initial matter, Plaintiffs’ assertion that their claims arise under Georgia law (Doc. 1 at 5 ¶ 4), appears incorrect. In cases involving personal injury, Arizona courts apply “the local law of the state where the injury occurred … unless, with respect to the particular issue, some other state has a more significant relationship … to the occurrence and the parties.” Bates v. Superior Court, 749 P.2d 1367, 1370 (Ariz. 1988 (quoting Restatement (Second) Conflict of Laws § 146); see Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487, 496 (1941) (federal court sitting in diversity must apply state choice-of-law principles). Mrs. Pablos alleges that she underwent the Essure procedure in Arizona and had the device removed in Arizona. (Doc. 1 at 38 ¶¶ 90-91.) Therefore, Arizona law should apply. However, the Court need not resolve the issue for purposes of this motion, as Plaintiffs’ claims fail under either Georgia or Arizona law. Further, while Bayer does not dispute that this Court has specific jurisdiction, because Mrs. Pablos’s claims arise out of Bayer’s contacts with Arizona, Plaintiffs are incorrect that Bayer’s limited contacts with Arizona are “so continuous and systematic” as to render Bayer “essentially at home” in the State. See BNSF Ry. v. Tyrrell, No. 16-405, 2017 WL 2322834, at *9 (May 30, 2017). Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 16 of 19 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 101784062_1 17 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 product liability cases. See, e.g., McLaughlin, 172 F. Supp. 3d at 836 (“[The complaint] does not allege that any [Essure] device affected by these errors was implanted in any of the [p]laintiffs, much less that any such manufacturing errors actually caused [the] [p]laintiffs’ injuries.”); De La Paz, 159 F. Supp. 3d at 1095 (“De La Paz’s claims also fail because she offers only conclusory allegations that the alleged irregularities caused her injuries.”); Hawkins v. Medtronic, Inc., No. 1:13-cv-00499, 2014 WL 346622, at *8 (E.D. Cal. Jan. 30, 2014) (“Plaintiff generally alleges that Defendants failed to report adverse events to the FDA. He also generally alleges that these failures caused or contributed to his injuries. What is not alleged is any factual content that would support the causal nexus. . . . Thus, claims based on Defendants’ failure to report adverse event[s] to the FDA cannot stand because they are not adequately pled.”); Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 1301 (D. Colo. 2008) (“The complaint does allege generally that the [device] was unreasonably dangerous and defective . . . , which proximately caused plaintiff’s injuries. However, such conclusory allegations standing alone are not sufficient to sustain plaintiff’s burden of pleading under Twombly.”). 2. Plaintiffs fail to plead fraud and misrepresentation with Particularity. Plaintiffs also fail to plead negligent misrepresentation with the requisite particularity. See Fed. R. Civ. P. 9(b). Plaintiffs “d[o] not allege specific facts showing that they relied” on the alleged misrepresentations. In re NationsMart Corp. Sec. Litig., 130 F.3d 309, 322 (8th Cir. 1997). Nor do they “claim that they ever read” the alleged misrepresentations or “specify which allegedly fraudulent statements they relied on in purchasing” Essure. Id. Plaintiffs’ fraud-based claims must be dismissed for this additional reason. IV. CONCLUSION For these reasons, this Court should dismiss Plaintiffs’ claims. DATED this 3rd day of July, 2017. Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 17 of 19 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 101784062_1 18 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 SIDLEY AUSTIN LLP – AND – LEWIS ROCA ROTHGERBER CHRISTIE LLP By: /s/ Jared L. Sutton Foster Robberson Jared L. Sutton Attorneys for Defendants Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 18 of 19 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 101784062_1 19 2 0 1 Ea st W as h in gt o n St re et ,S u it e 1 2 0 0 P h o en ix ,A Z 8 5 0 0 4 -2 5 9 5 CERTIFICATE OF SERVICE I hereby certify that on July 3, 2017, I electronically transmitted the attached document to the Clerk’s Office using the CM/ECF System for filing and transmittal of a Notice of Electronic Filing to the all CM/ECF registrants. /s/ May Livingston Case 2:17-cv-00863-DJH Document 16 Filed 07/03/17 Page 19 of 19