Souto et al v. Bayer, Corp. et al

MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM

E.D. Pa.June 12, 2017

Case 2:16-cv-01921-JLS Document 51 Filed 06/12/17 Page 1 of 3 Case 2:16-cv-01921-JLS Document 51 Filed 06/12/17 Page 2 of 3 CERTIFICATE OF SERVICE I, Christopher R. Boisvert, hereby certify that on June 12, 2017, the foregoing was filed via the Court’s CM/ECF system, which will automatically serve and send notification of such filing to all registered attorneys of record. /s/ Christopher R. Boisvert Case 2:16-cv-01921-JLS Document 51 Filed 06/12/17 Page 3 of 3 1 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA ALEXANDRA DUNSTAN et al., Plaintiff, v. BAYER ESSURE INC., et al Defendants. And Related Actions : : : : : : : : : : : : : : : : Case No. 2:16-cv-1458 The Hon. John R. Padova No. 16-1458 (Dunstan) No. 16-1645 (Clark) No. 16-1921 (Souto) No. 16-2166 (B. Bailey) No. 16-2154 (Campos) No. 16-2717 (Morgan) No. 16-3049 (Tulgetske) No. 16-3409 (Abbey) No. 16-3589 (Burgis) No. 16-3710 (Donahue) No. 16-3730 (Mantor) No. 16-3731 (O’Donnell) No. 16-3732 (Gross) No. 16-3733 (Johnson) No. 16-3766 (Summerlin) No. 16-3767 (Rodvill) No. 16-3768 (Bernal) No. 16-3769 (Aponte) No. 16-4081 (Bradford) MEMORANDUM IN SUPPORT OF DEFENDANTS’ OMNIBUS MOTION TO DISMISS UNDER FEDERAL RULE OF CIVIL PROCEDURE 12(b)(6) INTRODUCTION The Amended Complaints should be dismissed. First, the complaints in the above- captioned cases fail to follow this Court’s clear instructions in McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804 (E.D. Pa. 2016) (“McLaughlin I”), regarding the factual allegations necessary to plead a breach of express warranty claim.1 In particular, the complaints lack any specific allegations as to how and where “each Plaintiff” saw “each particular warranty,” and how each alleged warranty became the “basis of the bargain.” McLaughlin v. Bayer Corp., Nos. 14-7315 et al., 2017 WL 697047, *10 (E.D. Pa. Feb. 21, 2017) (“McLaughlin II”). Instead, just like the deficient allegations that this Court dismissed in McLaughlin I, the complaints allege generally 1 Bayer has filed answers to the Fourth Amended Complaints in McLaughlin (No. 14-7315), Ruble (No. 14-7316), Stelzer (No. 14-7318), Strimel (No. 14-7317), and Walsh (No. 15-0384). This motion does not apply to those five cases. Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 1 of 21 2 that all plaintiffs saw and relied on all the alleged warranties. The warranty claims should be dismissed for this reason. In addition, nearly all of the alleged negligent misrepresentations fail under this Court’s reasoning in McLaughlin II. The Court held in that case that almost all of the alleged fraudulent misrepresentations were expressly preempted because they are substantially the same as statements that the FDA approved for Essure’s labeling. See id. at *12-15. The exact same statements form the basis of the negligent misrepresentation claims here, and they are preempted for precisely the same reason. McLaughlin II did not apply that analysis to the negligent misrepresentation claims in that case, because a motion for reconsideration would have been necessary given its procedural posture. In these cases, there is no such procedural issue. The Court should therefore apply the same preemption analysis as in McLaughlin II, and hold that the negligent misrepresentation claims are expressly preempted. Bayer further respectfully reiterates its prior arguments that the remainder of the claims in the complaints—the training, risk management, warranty, and failure to warn claims—should also be dismissed because they are preempted and otherwise fail to state valid claims. See pp.15- 20, infra. Bayer recognizes that under the reasoning of this Court’s rulings in McLaughlin I and II, the complaints allege facts sufficient to state a non-preempted claim on these counts at this stage of the case. Bayer does not expect the Court to revisit its rulings at this juncture, but respectfully reasserts its arguments for the record. Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 2 of 21 3 BACKGROUND The plaintiffs in these twenty cases2 bring numerous causes of action alleging that they were injured by Essure, a Class III medical device that FDA granted pre-market approval (PMA) as a method of permanent female contraception. These cases are coordinated before this Court with the five complaints at issue in McLaughlin I and II, and the claims and allegations here are substantially the same as in those complaints. In McLaughlin I, the Court held that federal law preempts state common law claims concerning PMA medical devices such as Essure unless they fall within a “narrow gap”: “The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).” McLaughlin I, 172 F. Supp. 3d at 815 (quoting In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir.2010)). Further, the Court held that, under federal pleading standards, “[t]he complaint must contain ‘sufficient factual matter to show that the claim is facially plausible,’ thus enabling ‘the court to draw the reasonable inference that the defendant is liable for [the] misconduct alleged.’” Id. at 812 (quoting Warren Gen. Hosp. v. Amgen Inc., 643 F.3d 77, 84 (3d Cir. 2011)). Applying these standards, the Court granted judgment on the pleadings as to ten of the twelve claims in the complaint, with leave to amend five claims. The Court granted judgment with leave to amend on the express warranty claims in McLaughlin I because those complaints “fail[ed] to allege facts that give rise to a reasonable inference that each alleged warranty was an affirmation of fact or promise that formed a ‘basis of 2 The Amended Complaints in the above-captioned cases are materially identical as relevant to this motion. For simplicity’s sake, this motion cites the Dunstan complaint. Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 3 of 21 4 the bargain’ between Bayer and each Plaintiff.” McLaughlin I, 172 F. Supp. 3d at 823. Among other things, the complaints failed to “allege how or when each Plaintiff encountered each warranty beyond alleging the general time frame of ‘prior to implementation,’ which covers a period of years.” Id. Instead, the complaints made general allegations that the “Plaintiff relied on the [asserted] warranties.” See McLaughlin Am. Compl.¶ 101. The Court similarly granted judgment with leave to amend on the fraudulent misrepresentation claims, because they were not pled with the requisite specificity. The Court denied the motion as to the negligent misrepresentation claims. The Court held that all of the alleged misrepresentations would be expressly preempted unless plaintiffs could show “that Bayer made false or misleading statements in unapproved advertising or other promotional materials that were inconsistent with specific statements in approved FDA materials and that undermined the approved and required statements in those materials.” McLaughlin I, 172 F. Supp. 3d at 827. However, the Court deferred ruling on whether the particular alleged misrepresentations were inconsistent with the approved FDA labelling. Id. Plaintiffs subsequently amended the five complaints at issue in McLaughlin I. The amended complaints included specific allegations as to the dates and places where each plaintiff allegedly read each alleged warranty, the source of that warranty, and how it impacted the plaintiff’s decision to use the Essure device. For instance, plaintiff McLaughlin alleged that she “saw and read [a particular alleged] warranty at 814 North 9th St, Connellsville, PA 15425, on 12/27/11, which was located on an advertisement entitled ‘Are you Ready?’” McLaughlin Second Am. Compl. ¶ 146(j)(i). The dates, times, and places that the plaintiffs allegedly viewed the statements varied for each of the five plaintiffs, and the statements that each plaintiff allegedly viewed and relied upon varied somewhat as well. Compare, e.g., Stelzer Second Am. Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 4 of 21 5 Compl. ¶ 145(j)(i) (alleging that plaintiff Stelzer “saw and read [a particular alleged] warranty at 53 Downey Drive, Horsham, PA 19044, on 9/7/10, which was located on an advertisement entitled ‘When your family is complete, choose Essure.”). The Court determined that these amendments rectified the deficiencies in the warranty allegations in these five complaints. Specifically, the Court noted that the revised complaints alleged “the circumstances under which each Plaintiff read or saw each particular warranty,” “how each warranty came to be a basis of each Plaintiff’s bargain with Bayer,” “the date on which each Plaintiff encountered each warranty, where each Plaintiff was when she encountered the warranty, and the source of each warranty.” McLaughlin II, 2017 WL 697047, at *10. And on that basis, the Court concluded that those amended complaints “allege[d] sufficient facts to support a reasonable inference that the warranties were the bases of the parties’ bargains.” Id. In the same opinion, the Court dismissed nearly all of the alleged fraudulent misrepresentations as preempted. See id. at *17. The Court examined each of the alleged misrepresentations, and held that “the bulk of the alleged misrepresentations are not actionable because they are completely consistent with statements in FDA-approved materials and do not undermine—or overstate—the approved and/or required statements in those materials.” Id. at *12. The Court also dismissed two claimed misrepresentations for failure to allege elements of the cause of action. See id. at *17. The Court held that three of the alleged fraudulent misrepresentations were adequately pled. Id. at *19 (“the claims that remain in this case are ... (4) Count IV (fraudulent misrepresentation) insofar as it rests on three specific statements, i.e., (a) ‘there was ... no pain,’ (b) to be ‘identified as a qualified Essure physician,’ a physician must perform at least one Essure procedure every 6-8 weeks, and (c) ‘Step Two: pregnancy cannot occur; Step Three: The Confirmation.’”). Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 5 of 21 6 The Court declined to dismiss Plaintiff’s negligent misrepresentation claims on preemption grounds, although the alleged negligent misrepresentations were based on the same advertising statements, because Bayer had not moved for reconsideration of the decision in McLaughlin I. McLaughlin II, 2017 WL 697047, at *2 n.4. The Court further narrowed or dismissed the other claims, see id. at *19, and ordered Plaintiffs in all of the coordinated cases to file Amended Complaints that “conform to the rulings in this Court’s prior Orders (dated March 22, 2016, and February 21, 2017).” E.g., Dunstan, Dkt. 49, No. 5:16-cv-1458, at 1-2. The plaintiffs joined in this action filed their amended complaints on April 24, 2017. See Dunstan, Dkt. 51. The amended complaints challenge the same advertising statements that the Court considered in McLaughlin II. However, the amended complaints do not contain any plaintiff-specific allegations regarding these statements; they do not allege the date or place that each plaintiff saw each alleged warranty, and make no attempt to differentiate between the hundreds of individual plaintiffs as to which particular statements each plaintiff read, and how the statements impacted each plaintiff’s decision-making. ARGUMENT I. THE BREACH OF EXPRESS WARRANTY CLAIMS ARE INADEQUATELY PLEADED UNDER THIS COURT’S MCLAUGHLIN RULINGS. The warranty claims in these amended complaints plainly fail to state a claim under this Court’s rulings in McLaughlin I and II. This Court held that, “to meet the basis of the bargain requirement, ‘a plaintiff must prov[e] that she read, heard, saw or knew of the advertisement containing the affirmation of fact or promise.’” McLaughlin I, 172 F. Supp. 3d at 823 (alterations in original). Moreover, a “plaintiff cannot make a conclusory recitation of the elements of a cause of action and assume that it is sufficient to establish the existence of an express warranty”; she must ‘“plead[] factual content that allows a court to draw the reasonable Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 6 of 21 7 inference that the defendant is liable for the misconduct alleged.”’ Id. Accordingly, to state a claim for breach of warranty, the amended complaints must allege “the circumstances under which each Plaintiff read or saw each particular warranty, and how each warranty came to be a basis for each Plaintiff’s bargain with Bayer.” McLaughlin II, 2017 WL 697047, at *10 (emphasis added). Plaintiffs failed to include the required factual allegations for each plaintiff regarding each warranty. Their warranty claims are therefore inadequately pled. Indeed, the allegations stand in sharp contrast to the allegations that the Court found sufficient in McLaughlin II. The five complaints at issue there made specific allegations, different for each plaintiff, as to the statements each plaintiff read and relied upon, and the date and place that each plaintiff encountered each statement. See, e.g., Ruble 2nd Am. Compl. ¶ 144(l)(i) (alleging that plaintiff Rule “saw and read [a particular alleged] warranty at 249 Meadowbrook Rd., Hermitage, PA 161148, on 10/25/11, which was located on a booklet advertisement entitled ‘Essure: Permanent Birth Control’”); p.4, supra (citing corresponding language in McLaughlin and Stelzer). Here, however, the amended complaints contain only general allegations, common to all plaintiffs, that “Plaintiffs relied on and actually saw this warranty and believed it to be true.” Dunstan Am. Compl. ¶ 197. The amended complaints do not allege the date that each plaintiff read each alleged warranty, nor where each plaintiff was located when she encountered it. Further, the amended complaints make no attempt to differentiate between the hundreds of individual plaintiffs; rather, they plead that all plaintiffs read and relied upon the exact same advertising statements. Id. And they plead that each of the statements had the exact same impact on each of the hundreds of plaintiff’s decisions to use the Essure device. See, e.g., Dunstan Am. Compl. ¶ 197(r) (alleging that a warranty became the “basis of the bargain” for all Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 7 of 21 8 nine plaintiffs because each “wanted a reliable type of birth control that was made of safe material which would not cause her serious health problems.”).3 The amended warranty claims should therefore be dismissed, because they fail to satisfy this Court’s instruction to “conform to the rulings in this Court’s prior Orders” in McLaughlin I and II. Dkt. 49, No. 5:16-cv-1458. The generic language in the amended complaints, making no effort to distinguish between the experiences of the hundreds of individual plaintiffs, do not “allege how or when each Plaintiff encountered each warranty.” McLaughlin I, 172 F. Supp. 3d at 823; see McLaughlin II, 2017 WL 697047, at *10. The warranty claims also fail the plausibility standard. See Warren Gen. Hosp., 643 F.3d at 84 (a complaint must contain “sufficient factual matter to show that the claim is facially plausible”). The amended complaints join hundreds of plaintiffs, who had their Essure devices placed over a span of many years. For instance, in Dunstan, the amended complaint alleges that nine individual Plaintiffs had their devices placed as early as November 2008, Dunstan Am. Compl. ¶ 116 (Jennifer Kalin), and as late as February 2014, id. ¶ 115 (Angela Mehalek). Nonetheless, the amended complaint alleges that each of the nine plaintiffs read the exact same twenty statements in the exact same brochures and website pages, and that each of these twenty statements had the exact same impact on each plaintiff’s decision. E.g., id. ¶ 197. The other 19 complaints, joining hundreds more plaintiffs, likewise allege that all of the plaintiffs read and relied on these same twenty statements. It is simply not plausible that hundreds of separate individuals, over the course of about a decade, had precisely the same experience. The warranty claim should be dismissed. 3 The only exception is that the amended complaints state that “[t]he warranties and misrepresentations relating to pregnancy apply to only those plaintiffs that became pregnant.” E.g., Dunstan Am. Compl. ¶ 197 n.7. Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 8 of 21 9 II. THE MAJORITY OF THE NEGLIGENT MISREPRESENTATION CLAIMS ARE EXPRESSLY PREEMPTED UNDER THE REASONING OF THIS COURT’S MCLAUGHLIN RULINGS. In addition, the bulk of the negligent misrepresentation claims should be dismissed because they are plainly preempted under the reasoning of McLaughlin II. Evaluating the exact same advertising statements as part of the fraudulent misrepresentation claims, McLaughlin II held that they are expressly preempted “because they are completely consistent with statements in FDA-approved materials and do not undermine—or overstate—the approved and/or required statements in those materials.” McLaughlin II, 2017 WL 697047, at *12. The negligent misrepresentation claims are expressly preempted for precisely the same reason. Although McLaughlin II did not dismiss negligent misrepresentation claims, that was due to a procedural issue that is not present here. In McLaughlin I and II, this Court held that, for both fraudulent and negligent misrepresentation, to “state a misrepresentation claim that was not expressly preempted, Plaintiffs would need to ‘allege that Bayer made false or misleading statements in unapproved advertising or other promotional materials that were inconsistent with specific statements in approved FDA materials and that undermined the approved and required statements in those materials.’” McLaughlin II, 2017 WL 697047, at *12 (quoting McLaughlin I, 172 F. Supp. 3d at 827). Any misrepresentation claim based on a statement consistent with the FDA-approved labeling would impose a “requirement” relating to the safety or effectiveness of the device that “is different from, or in addition to, any requirement applicable . . . to the device” under federal law, and therefore be expressly preempted by 21 U.S.C. § 360k(a). McLaughlin I, 172 F. Supp. 3d at 815. Multiple other decisions have agreed with this Court’s rulings in McLaughlin and adopted the same legal framework for evaluating misrepresentation claims. See, e.g., Norman v. Bayer Corp., No. 16-253, 2016 WL 4007547, at *6 (D. Conn. July 26, 2016); Burrell v. Bayer Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 9 of 21 10 Corp., No. 1:17-cv-00031, 2017 WL 195533, at *8 (W.D.N.C. May 10, 2017); De La Paz v. Bayer HealthCare LLC, 159 F. Supp. 3d 1085, 1097-99 (N.D. Cal. 2016). As detailed in the chart below, this Court has already determined that many of the statements alleged as negligent misrepresentations here are consistent with Essure’s FDA- approved labeling, and therefore expressly preempted: Alleged Misrepresentations in Amended Complaint FDA-Approved Labeling McLaughlin II Holding “Only FDA approved female sterilization procedure to have zero pregnancies in the clinical trials.” Dunstan, Am. Compl. ¶ 208(m). “There were zero pregnancies in the clinical trials.” Am. Compl. ¶ 208(n). ‘“Zero pregnancies’ in its clinical or pivotal trials.” Am. Compl. ¶ 208(v). “In the Essure clinical studies, zero (0) pregnancies were reported in women who had the Essure Inserts for up to five years.” RJN, Ex. A at 12 (2013 PIB). “We … conclude that Bayer’s statements on the website and in a brochure that there zero pregnancies in the clinical trials is completely consistent with at least one FDA-approved statement in the PIB. Accordingly, [the claim is] expressly preempted.” McLaughlin II, 2017 WL 697047, at *13. “Physicians must be signed- off to perform Essure procedures.” Am. Compl. ¶ 208(o). “Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training Manual; and have successfully completed the Essure® training program.” RJN, Ex. B at 1 (2013 IFU). “Bayer’s statement on its website that physicians must be ‘signed-off’ to perform Essure procedures is completely consistent with the FDA’s statement that physicians should successfully complete the product training program before implanting the device. Accordingly, [the claim is] expressly preempted.” McLaughlin II, 2017 WL 697047, at *13. “Worry free: Once your doctor confirms that your tubes are blocked, you never have to worry about “Essure may be right for you if . . . You would like to stop worrying about getting “We conclude that the FDA- approved statements in the PIB plainly convey that Essure users need not worry Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 10 of 21 11 unplanned pregnancy.” Am. Compl. ¶ 208(p). “You’ll never have to worry about unplanned pregnancy again.” Am. Compl. ¶ 208(x). “Worry free.” Am. Compl. ¶ 208(z). pregnant.” RJN, Ex. A at 4 (2013 PIB). about getting pregnant and thus are the equivalent of the statements for which Plaintiffs seek to hold Bayer liable. We therefore further conclude that Plaintiffs seek to hold Bayer liable for what are, in essence, FDA- approved statements. The . . . claims based on these three statements are thus expressly preempted.” McLaughlin II, 2017 WL 697047, at *13. “Essure is the most effective permanent birth control available-even more than tying your tubes or a vasectomy.” Am. Compl. ¶ 208(q). Comparing vasectomy, tubal ligation, and other methods of contraception, each listing a higher rate of failure than Essure. See RJN, Ex. A at 15-19 (2013 PIB). Essure is “99.83% effective.” See RJN, Ex. A at 5, 10, 12 (2013 PIB). “This statement, however, is fully consistent with information in the PIB, which compares Essure with tubal ligation and vasectomy procedures and shows that the rate of failure for each is higher (i.e., the number of pregnancies is higher) than that of Essure. Accordingly, Plaintiffs’ … claim based on this statement is expressly preempted.” McLaughlin II, 2017 WL 697047, at *14. “Correct placement … is performed easily because of the design of the micro- insert.” Am. Compl. ¶ 208(r). Essure “may be right” for those who “prefer a method or procedure that . . . [i]s simple and does not take a lot of time.” See RJN, Ex. A at 4 (2013 PIB). “Essure is a simple procedure that can be done in 10 minutes in your doctor’s office.” See RJN, Ex. A at 5 (2013 PIB). This challenged statement, however, is completely consistent with, and does not overstate, the FDA-approved statement in the PIB. … We therefore conclude that Plaintiffs’ … claim based on this statement is expressly preempted.” McLaughlin II, 2017 WL 697047, at *14. “In order to be trained in Essure you must be a skilled operative hysteroscopist. You will find the procedure “Device to be used only by physicians who are knowledgeable hysteroscopists; have read “Bayer’s statement that a physician must be a skilled hysteroscopist to be trained to use Essure is completely Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 11 of 21 12 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.” Am. Compl. ¶ 208(t). and understood the Instructions for Use and Physician Training Manual; and have successfully completed the Essure® training program.” RJN, Ex. B at 1 (2013 IFU). consistent with that federal requirement, and Plaintiffs’ … claim based on this statement is expressly preempted.” McLaughlin II, 2017 WL 697047, at *15. “Essure is a surgery-free permanent birth control.” Am. Compl. ¶ 208(u). “Essure eliminates the risks, discomfort, and recovery time associated with surgical procedures.” Am. Compl. ¶ 208(dd). “Essure is a … permanent birth control procedure- without … the risks of getting your tubes tied.” Am. Compl. ¶ 208(ee). Essure “[d]oes not require surgery.” See RJN, Ex. A at 4 (2013 PIB). The “Benefits of Essure,” include that it is “Non- Surgical,” that “No General Anesthesia [is] Required,” and that “[m]ost women return to normal activity within one to two days.” See RJN, Ex. A at 5 (2013 PIB). “[W]e conclude that the statements at issue regarding the process of implanting Essure are consistent with, and largely equivalent to, FDA-approved statements and we find the . . . claims based [on] these statements to be expressly preempted.” McLaughlin II, 2017 WL 697047, at *14. “[T]he tip of each insert remains visible to your doctor, so proper placement can be confirmed.” Am. Compl. ¶ 208(y). “The 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.” Am. Compl. ¶ 208(aa). “This viewable portion of the microinsert serves to verify placement.” Am. Compl. ¶ 208(gg). “Ideally, 3 to 8 expanded outer coils should be trailing into the uterus.” See RJN, Ex. B at 8 (2013 IFU). “After 3 months, a doctor will administer the Essure Confirmation Test. The test will verify that the inserts are in their correct location.” RJN, Ex. A at 6 (2013 PIB). “The [Essure] insert expands upon release to conform to and acutely anchor in the tubal lumen[, which] elicits a benign tissue in-growth that permanently occludes the fallopian tube, resulting in “[T]he IFUs specifically instruct the physician how to implant Essure and advise the physician to verify proper placement during implantation by assessing the ‘visible’ portion of the device and the number of ‘visible’ trailing coils. The PIB further states that [a confirmation test] ‘will verify that the inserts are in their correct location . . . and properly placed.’ Furthermore, the PIB specifically states that the patient’s ‘body will . . . develop a natural barrier [and] anchor[] itself.’ We . . . Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 12 of 21 13 contraception.” RJN, Ex. B at 1 (2013 IFU). “Over the next 3 months, your body will form . . . a natural barrier within the fallopian tubes.” See RJN, Ex. A at 6 (2013 PIB). conclude that Plaintiffs’ . . . claim based on . . . the statements . . . that ‘the viewable portion of the micro-insert serves to verify placement’ are consistent with, and equivalent to, FDA- approved statements and, thus, Plaintiffs’ fraudulent misrepresentation claims grounded on those remaining statements are expressly preempted.” McLaughlin II, 2017 WL 697047, at *15. “The Essure inserts are made from the same trusted, silicone free material used in heart stents.” Am. Compl. ¶ 208(bb). “The inserts are made from … safe, trusted material.” Am. Compl. ¶ 208(ff). “These same materials have been used for many years in cardiac stents and other medical devices placed in other parts of the body.” See RJN, Ex. A at 11 (2013 PIB). “We … conclude that these two statements are consistent with FDA-approved statements and, as a result, the … claims based on those statements are expressly preempted.” McLaughlin II, 2017 WL 697047, at *15. Other decisions have similarly dismissed fraudulent and negligent misrepresentation claims based on these statements as expressly preempted. See, e.g., Norman, 2016 WL 4007547, at *5-6; De La Paz v. Bayer HealthCare LLC, 159 F. Supp. 3d at 1097-99. Although McLaughlin II dismissed the fraudulent but not the negligent misrepresentation claims, this result was not due to any distinction in the express preemption analysis, but rather to a procedural issue unique to those five complaints. McLaughlin II, 2017 WL 697047, at *2 n.4. Indeed, in McLaughlin I, the Court recognized that the same preemption standard applies to both negligent and fraudulent misrepresentation claims: the claims are expressly preempted unless the challenged statements are “inconsistent with specific statements in approved FDA materials.” McLaughlin I, 172 F. Supp. 3d at 827. Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 13 of 21 14 However, McLaughlin I did not grant judgment against the negligent misrepresentation claim, “reach[ing] no conclusions” as to whether specific statements were preempted at that stage in the case, because the briefing there “did not specify which representations appeared in FDA-approved materials or precisely where they appeared.” Id. at n.20. Due to this ruling in McLaughlin I, McLaughlin II also declined to dismiss the negligent misrepresentation claims from those five complaints, holding that the motion to dismiss those claims “constitutes a request for reconsideration that is . . . untimely” and “fails to identify an approved basis for reconsideration.” McLaughlin II, 2017 WL 697047, at *2 n.4. Here, no request for reconsideration is necessary because this Court has never before considered the adequacy of the negligent misrepresentation pleadings in these twenty complaints. Accordingly, there is no procedural obstacle to considering whether the negligent misrepresentation claims here are expressly preempted. The bulk of the alleged negligent misrepresentations here are identical to the statements the Court held preempted in McLaughlin II, and they are preempted for the exact same reason. The Court should therefore reach the issue and dismiss these claims. 4 In addition, McLaughlin II dismissed one of the alleged fraudulent misrepresentations— “the Essure training program is a comprehensive course designed to provide information and skills necessary to select appropriate patients, perform competent procedures and manage technical issues related to the placement of Essure micro-inserts for permanent birth control”— on the ground that it was directed at physicians and was clearly not intended to induce reliance by potential patients. Id. at *17; Dunstan Am. Compl. ¶ 208(s). Because intent to induce 4 The statements that the Court held preempted in McLaughlin II are contained in Subparts (m), (n), (o), (p), (q), (r), (t), (u), (v), (x), (y), (z), (aa), (bb), (dd), (ee), and (ff) of Paragraph 208 of the Dunstan amended complaint. Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 14 of 21 15 reliance is equally a requirement of negligent misrepresentation, the negligent misrepresentation claim based on this statement should be dismissed as well. McLaughlin I, 172 F. Supp. 3d at 830 (citing Bilt-Rite Contractors, Inc. v. The Architectural Studio, 866 A.2d 270, 277 (Pa. 2005)).5 III. PLAINTIFFS’ OTHER CLAIMS ARE PREEMPTED AND INADEQUATELY PLEADED. Plaintiffs’ remaining claims—negligent training, negligent risk management, fraudulent misrepresentation, failure to warn, and the remaining portions of the negligent misrepresentation claim—track claims that this Court held were adequately pled in McLaughlin I and II. Bayer does not expect the Court to revisit those issues at this time. However, for the record, Bayer respectfully disagrees with those aspects of McLaughlin I and II, and respectfully reiterates its arguments that the remainder of the claims in the amended complaints should also be dismissed. A. Federal Law Preempts Plaintiffs’ Claims. 1. Plaintiffs’ training claims are preempted. Plaintiffs claim that Bayer had a duty to train Plaintiffs’ physicians and failed to meet this obligation by not “[e]nsur[ing] that the implanting physicians completed the required preceptoring (generally 5 cases) in Essure placement until competency,” “[e]nsur[ing] that the implanting physicians had read and understood the Physician Training Manual,” and “[e]nsur[ing] that the implanting physicians had ‘successful completion of Essure Simulator 5 Three of the alleged negligent misrepresentations are the same as statements that McLaughlin II held to be adequately pled: “(a) ‘there was ... no pain,’ (b) to be ‘identified as a qualified Essure physician,’ a physician must perform at least one Essure procedure every 6-8 weeks, and (c) ‘Step Two: pregnancy cannot occur; Step Three: The Confirmation.’” McLaughlin II, 2017 WL 697047, at *19; Dunstan Am. Compl. ¶ 208(w), (cc), (hh). One additional alleged negligent misrepresentation is the same as a statement that McLaughlin II dismissed for failure to adequately plead knowledge of falsity, a requirement of fraudulent but not negligent misrepresentation. McLaughlin II, 2017 WL 697047, at *17 (statement that “the viewable portion of the micro-insert . . . does not irritate the lining of the uterus.”); Dunstan Am. Compl. ¶ 208(gg). Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 15 of 21 16 Training.’” E.g., Dunstan Am. Compl. ¶ 172. This claim is preempted because Plaintiffs fail to “allege . . . any facts that give rise to a recognizable theory as to how any departure from the training guidelines may have caused [Plaintiffs’ injuries].” McLaughlin I, 172 F. Supp. 3d at 817. Indeed, Plaintiffs fail to allege how the vague and overbroad alleged inadequacies in the training caused their injuries. See, e.g., Dunstan Am. Compl. ¶¶ 175-76. Without such allegations, Plaintiffs have failed to state a non-preempted cause of action. A contrary conclusion would “permit a jury to decide [Plaintiffs’] claims that the . . . training material the FDA required and approved through the PMA process were inadequate under state law.” Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919, 931 (5th Cir. 2006). For that reason, numerous courts have rejected virtually identical claims against Essure. De La Paz, 159 F. Supp. 3d at 1096; Norman, 2016 WL 4007547, at *5; Burrell, 2017 WL 1955333, at *6. This Court should do the same. 2. Plaintiffs’ risk management claims are preempted. Plaintiffs’ risk management claims are little more than recitations of sections in the Code of Federal Regulations and conclusory allegations that Bayer failed to comply with its risk analysis obligations, including reporting adverse events, tracking non-conforming product, and updating its labeling. See, e.g., Dunstan Am. Compl. ¶¶ 184-88. Tellingly, they do not allege how Bayer’s purported failures caused their injuries. Instead they assert, without any supporting factual allegations, that an incomplete risk management plan somehow prevented Plaintiffs from “knowing of the thousands of migrations, perforations, pregnancies, device failures and malfunctions.” E.g., id. ¶ 187. Such conclusory statements, however, are not enough to clear the causation hurdle. See Stengel v. Medtronic, Inc., 704 F.3d 1224, 1234 (9th Cir. 2013) (en banc) (Watford, J., concurring); see also McLaughlin II, 2017 WL 697047, at *2 (recognizing that Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 16 of 21 17 “[l]egal conclusions . . . receive no deference, as the court is not bound to accept as true a legal conclusion couched as a factual allegation”). Therefore, this claim is preempted. 3. Plaintiffs’ failure to warn claims are preempted. Plaintiffs’ failure to warn claims are impliedly preempted to the extent they are based on Bayer’s alleged failure to report adverse events or other information to FDA, because they are “simply an attempt by [a] private part[y] to enforce the MDA.” In re Medronic, 623 F.3d at 1205. In Buckman, the Supreme Court made clear that “it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance” with FDA reporting requirements. 531 U.S. at 349 n.4 (citing 21 U.S.C. § 337). Stengel, which held that a similar claim was not preempted, is wrongly decided because it runs counter to the Supreme Court’s holding in Buckman, and there is no indication that the Third Circuit would follow it, rather than the persuasive decision of the Eighth Circuit, In re Medtronic, 623 F.3d at 1205-06. In addition, 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. As in their risk management claim, Plaintiffs allege in conclusory fashion that, had Bayer reported certain adverse events, e.g., Dunstan Am. Compl. ¶ 221, they never would have “had Essure implanted,” id. But Plaintiffs never explain how reporting adverse events to FDA would have warned Plaintiffs and their physicians, nor do they assert any facts to show such an outcome is plausible. See Norman, 2016 WL 4007547, at *4 (“[P]laintiff fails to plead facts that plausibly connect defendants’ alleged reporting violations to her injuries.”). The situation is thus similar to De La Paz, where the court found that “De La Paz . . . failed to plausibly show that her injuries would have been prevented if Bayer had properly reported the perforation events—a necessary element of her failure-to-warn-the-FDA claim.” 159 F. Supp. 3d at 1097. So too here. Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 17 of 21 18 Moreover, FDA has never withdrawn its approval of Essure. It has been aware for years of the adverse events that Plaintiffs claim Bayer failed to timely report, see, e.g., Dunstan Am. Compl. ¶¶ 73 (noting 2002 inspection), 74 (noting 2010 inspection), 77 (noting 2011 inspection), yet FDA continues to state that “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control,” RJN, Ex. C (News Release). Without demonstrating causation, Plaintiffs cannot state a non-preempted claim. 4. Plaintiffs’ warranty claims are preempted. Plaintiffs’ warranty claims are preempted for the same reason as their misrepresentation claims: they challenge statements that are substantially the same as Essure’s FDA-approved labeling. Warranty claims are state “requirements” subject to preemption under the MDA under Riegel v. Medtronic, 552 U.S. 312 (2008), which held that the preemption provision’s “reference to a State’s ‘requirements’ includes its common-law duties.” Id. at 324. Warranty is a “common-law duty,” just like misrepresentation or any other type of common-law claim is. Furthermore, imposing liability for statements that FDA has approved interferes with FDA’s authority to regulate medical devices, however the state-law claim is captioned. Accordingly, multiple courts have recognized that the MDA preempts express warranty claims. See, e.g., Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (“express warranty claims cannot be used to impose requirements greater than that provided by the FDA regulations”); In re Medtronic, 623 F.3d at 1208 (the “express warranty claim interferes with the FDA’s regulation of Class III medical devices and is therefore conflict preempted”); Horowitz v. Styker Corp., 613 F. Supp. 2d 271, 285 (E.D.N.Y. 2009) (similar); De La Paz, 159 F. Supp. 3d at 1098 (“The misrepresentation claims are based on the same statements that form the basis of De La Paz’s claim for breach of express warranties, and they are preempted for the same reasons as that claim Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 18 of 21 19 (namely, the statements conformed to statements approved by the FDA).”); Norman, 2016 WL 4007547, at *5; Burrell, 2017 WL 1955333, at *7. And even if the MDA’s preemption provision did not apply to “a voluntary contractual promise,” see Cline v. Advanced Neuromodulation Sys., 914 F. Supp. 2d 1290, 1294 (N.D. Ga. 2012) (emphasis added), Plaintiffs do not allege that they entered into such a “contract” with Bayer here. Rather, the alleged warranties are identical to the alleged misrepresentations, and are simply advertising statements. B. Plaintiffs’ Claims Do Not Comply With Federal Pleading Standards. The amended complaints also fail for the separate reason that they do not state a valid cause of action. First, all of the claims are inadequately pleaded because they fail to allege facts showing causation. Second, Plaintiffs’ negligent misrepresentation claims fail because they have not alleged facts showing reasonable reliance. 1. Plaintiffs have failed to plead causation adequately. Causation is an essential element of Plaintiffs’ claims, and they have failed to plead sufficient factual matter to satisfy Rule 12(b)(6). In federal court, a “complaint must contain sufficient factual matter to show that the claim is facially plausible, thus enabling the court to draw the reasonable inference that the defendant is liable for [the] misconduct alleged.” McLaughlin II, 2017 WL 697047, at *2. “A complaint that pleads facts merely consistent with a defendant’s liability . . . stops short of the line between possibility and plausibility of entitlement to relief.” Id. In these cases, Plaintiffs’ causation allegations do not meet the probability requirement. They allege only that “[a]s a result of [Bayer’s] negligence,” they suffered various injuries. See, e.g., Dunstan Am. Compl. ¶ 179. These boilerplate allegations are merely recitations of the cause of action. They are insufficient, and Plaintiffs’ claims fail as a result. Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 19 of 21 20 2. Plaintiffs’ negligent misrepresentation claims fail. Plaintiffs must plead “justifiable reliance” to state a valid negligent misrepresentation claim. McLaughlin I, 172 F. Supp. 3d at 830. They have failed to do so. Instead they merely assert that “Plaintiffs relied on . . . [the identified statements] and believed [them] to be true.” E.g., Dunstan Am. Compl. ¶ 208(m)(i). As with causation, these allegations just parrot the elements of the cause of action—which is insufficient under Rule 12(b)(6). See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (“a formulaic recitation of a cause of action’s elements will not do”). The claims should therefore be dismissed. 3. Plaintiffs’ loss of consortium claims fail. Finally, three of the Amended Complaints—Campos (No. 16-2154), Morgan (No. 16- 2717), and Tulgetske (No. 16-2717)—include male Plaintiffs, each of whom allegedly suffered a loss of consortium when his wife was injured by Essure. Because the underlying claims of Plaintiffs’ wives fail, however, Plaintiffs’ claims necessarily fail as well. Loss of consortium is a “derivative claim,” and as such, “is ‘always dependent upon the injured spouse’s right to recover.’” Nationwide Mut. Ins. Co. v. Cosenza, 258 F.3d 197, 206 (3d Cir. 2001) (quoting Scattaregia v. Shin Shen Wu, 495 A.2d 552, 554 (Pa. Super. Ct. 1985)). In these cases, Plaintiffs’ spouses do not have a “right to recover,” because their claims are preempted or insufficiently pled. This Court should accordingly dismiss the loss of consortium claims. CONCLUSION The Court has ordered the Plaintiffs to conform their pleadings to its rulings in McLaughlin I and II. Plaintiffs have failed to do so. Their warranty claims omit factual allegations regarding the circumstances in which each Plaintiff encountered the alleged warranties and how those representations came to be the basis of the parties’ bargain. Their Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 20 of 21 21 negligent misrepresentation claims are preempted because they are largely based on statements that this Court has already determined are consistent with the FDA-approved labeling. These claims should therefore be dismissed. In addition, Bayer respectfully reiterates and preserves its arguments that the remainder of the claims should also be dismissed. Dated: June 12, 2017 DECHERT LLP By: /s/ Robert C. Heim Robert C. Heim robert.heim@dechert.com DECHERT LLP Cira Centre 2929 Arch Street Philadelphia, PA 19104 Telephone: +1 215 994-2570 Jonathan F. Cohn (pro hac vice) jfcohn@sidley.com Rebecca K. Wood (pro hac vice) rwood@sidley.com SIDLEY AUSTIN LLP 1501 K Street, N.W. Washington, D.C. 20005 Telephone: +1 202 736-8000 Attorneys for Defendants Bayer Essure Inc. and Bayer HealthCare Pharmaceuticals Inc. Case 2:16-cv-01921-JLS Document 51-1 Filed 06/12/17 Page 21 of 21 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA ALEXANDRA DUNSTAN et al., Plaintiffs, v. BAYER ESSURE INC. et al., Defendants. And Related Actions : : : : : : : : : : : : : : : : Case No. 2:16-cv-1458 The Hon. John R. Padova NO. 16-1458 (Dunstan) NO. 16-1645 (Clark) NO. 16-1921 (Souto) NO. 16-2166 (B. Bailey) NO. 16-2154 (Campos) NO. 16-2717 (Morgan) NO. 16-3049 (Tulgetske) NO. 16-3409 (Abbey) NO. 16-3589 (Burgis) NO. 16-3710 (Donahue) NO. 16-3730 (Mantor) NO. 16-3731 (O’Donnell) NO. 16-3732 (Gross) NO. 16-3733 (Johnson) NO. 16-3766 (Summerlin) NO. 16-3767 (Rodvill) NO. 16-3768 (Bernal) NO. 16-3769 (Aponte) NO. 16-4081 (Bradford) ORDER AND NOW, this ____ day of _____________, 2017, upon consideration of the Defendants’ Omnibus Motion to Dismiss Under Fed. R. Civ. P. 12(b)(6), the Memorandum of Law in support thereof, and any Response thereto, it is hereby ORDERED that said Motion is GRANTED. BY THE COURT: ________________________________ Padova, J. Case 2:16-cv-01921-JLS Document 51-2 Filed 06/12/17 Page 1 of 1