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McLaughlin v. Bayer Corp.

United States District Court, E.D. Pennsylvania

February 21, 2017

HELEN McLAUGHLIN
v.
BAYER CORPORATION, et al. RUTH RUBLE
v.
BAYER CORPORATION, et al. MELDA STRIMEL
v.
BAYER CORPORATION, et al. SUSAN STELZER
v.
BAYER CORPORATION, et al. HEATHER WALSH
v.
BAYER CORPORATION, et al.

          MEMORANDUM

          John R. Padova, J.

         Each Plaintiff in these five consolidated actions seeks compensation for injuries she sustained in connection with her use of Essure, a female birth control device. In a prior opinion in this case, McLaughlin v. Bayer, 172 F.Supp.3d 804 (E.D. Pa. 2016), we considered a Motion for Judgment on the Pleadings with respect to Plaintiffs' First Amended Complaints and exhaustively analyzed Plaintiffs' claims, dismissing some claims with prejudice, dismissing others with leave to amend, and denying the Motion as to the two remaining claims. Plaintiffs subsequently filed Second Amended Complaints, which assert seven claims for relief against Defendants Bayer Corp., Bayer Healthcare LLC, Bayer Essure, Inc., and Bayer Healthcare Pharmaceuticals (collectively, “Bayer”). Bayer has filed an identical Motion to Dismiss in each of the five cases, seeking dismissal of five of the seven Counts asserted in the Second Amended Complaints pursuant to Federal Rule of Civil Procedure 12(b)(6). For the following reasons, we grant the Motion in part and deny it in part.

         I. BACKGROUND[1]

         The Second Amended Complaint in the McLaughlin case (“the SAC”) alleges that Bayer manufactures, sells, distributes, markets and promotes Essure.[2] (SAC ¶ 46.) It describes Essure as metal coils, which are placed in a woman's fallopian tubes and are intended to block the tubes and prevent pregnancy. (Id. ¶¶ 34, 38.) The coils are inserted by a doctor using hysteroscopic equipment. (Id. ¶¶ 34-35.) The SAC alleges that, instead of working as intended, “the device migrates from the tubes, perforates organs, breaks into pieces, and/or corrodes.” (Id. ¶ 16.) Each Plaintiff had Essure implanted and subsequently suffered serious consequences when the device migrated from her fallopian tubes to her uterus, rectum or colon. (See, e.g., SAC ¶¶ 100-104.)

         Because Essure is classified as a Class III medical device, the Food and Drug Administration (the “FDA”) evaluated Essure's safety and effectiveness prior to granting the product Conditional Premarket Approval (“PMA”), which authorized its commercial distribution. (Id. ¶¶ 18, 49; 11/4/02 PMA letter (“PMA Ltr.”) at 1.[3]) Such approval was contingent upon the FDA's finding that there was “a ‘reasonable assurance' of the device's ‘safety and effectiveness.'” Riegel v. Medtronic, Inc., 552 U.S. 312, 318 (2008) (quoting 21 U.S.C. § 360e(d)). At the same time, the PMA imposed certain conditions on Bayer's distribution of the product, including certain labeling requirements and restrictions on false and/or misleading advertising. (PMA Ltr. at 1.)

         The SAC asserts seven causes of action, which seek to hold Bayer liable for the injuries Plaintiffs suffered as a result of their use of Essure. Count I asserts a claim of negligent training, alleging that Bayer undertook responsibility for training physicians how to implant Essure and then did so negligently. Count II asserts a claim for negligent risk management, alleging that Bayer failed to adequately track and review complaints about Essure's performance. Count III asserts a claim for breach of express warranty, grounded on various representations and promises about Essure made in promotional materials and on Essure's website. Counts IV and V assert claims of fraudulent misrepresentation and negligent misrepresentation, alleging that the same statements that constituted warranties about Essure, also constituted actionable misrepresentations. Count VI alleges that Bayer negligently manufactured Essure. Count VII asserts that Bayer negligently failed to warn Plaintiffs and the implanting physicians of the risks of the device and manufacturing defects. Bayer has moved to dismiss Counts I, II, III, IV, and VI, arguing both that certain claims are expressly preempted and that the SAC does not adequately allege essential elements of the claims asserted.[4]

         II. LEGAL STANDARDS

         A. Motion to Dismiss Pursuant to Rule 12(b)(6)

         When considering a motion to dismiss pursuant to Rule 12(b)(6), we “consider only the complaint, exhibits attached to the complaint, [and] matters of public record, as well as undisputedly authentic documents if the complainant's claims are based upon these documents.” Mayer v. Belichick, 605 F.3d 223, 230 (3d Cir. 2010) (citing Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir. 1993)). We take the factual allegations of the complaint as true and draw all reasonable inferences in favor of the plaintiff. DelRio-Mocci v. Connolly Props., Inc., 672 F.3d 241, 245 (3d Cir. 2012) (citing Warren Gen. Hosp. v. Amgen, Inc., 643 F.3d 77, 84 (3d Cir. 2011)). Legal conclusions, however, receive no deference, as the court is “‘not bound to accept as true a legal conclusion couched as a factual allegation.'” Wood v. Moss, 134 S.Ct. 2056, 2065 n.5 (2014) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)).

         A plaintiff's pleading obligation is to set forth “a short and plain statement of the claim, ” Fed.R.Civ.P. 8(a)(2), which gives the defendant “‘fair notice of what the . . . claim is and the grounds upon which it rests.'” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (alteration in original) (quoting Conley v. Gibson, 355 U.S. 41, 47 (1957)). The 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.'” Warren Gen. Hosp., 643 F.3d at 84 (quoting Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009)). “The plausibility standard is not akin to a ‘probability requirement, ' but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Iqbal, 556 U.S. at 678 (citing Twombly, 550 U.S. at 556). “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.'” Connelly v. Lane Constr. Corp., 809 F.3d 780, 786 (3d Cir. 2016) (alteration in original) (quoting Iqbal, 556 U.S. at 678). “The plausibility determination ‘is a context-specific task that requires the reviewing court to draw on its judicial experience and common sense.'” Id. 786-87 (quoting Iqbal, 556 U.S. at 679). In the end, we will grant a motion to dismiss brought pursuant to Rule 12(b)(6) if the factual allegations in the complaint are not sufficient “‘to raise a right to relief above the speculative level.'” W. Run Student Hous. Assocs., LLC v. Huntington Nat'l Bank, 712 F.3d 165, 169 (3d Cir. 2013) (quoting Twombly, 550 U.S. at 555).

         B. Express Preemption

         The Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq. (the “MDA”), expressly preempt certain state law requirements, stating that:

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 - -
(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.

21 U.S.C. § 360k(a).

         In Riegel v. Medtronic, Inc, the Supreme Court set forth a two-step analysis for determining whether a claim is expressly preempted pursuant to the statute. 552 U.S. at 321-22. First, the court must ascertain whether the federal government has established requirements applicable to the medical device at issue. Id. at 321. The Supreme Court concluded that any Class III device that receives premarket approval, which is specific to individual devices, satisfies this first prong of the § 360k(a) test. Id. at 322 (“Premarket approval . . . imposes ‘requirements' under the MDA . . . .”); see also Hughes v. Boston Sci. Corp., 631 F.3d 762, 768 (5th Cir. 2011) (“Riegel established that any Class III device receiving PMA approval from the FDA will satisfy this first prong of the test . . . .” (citing Riegel, 552 U.S. at 322)). Second, the court must determine whether the state common law claims relate to safety and effectiveness and impose requirements that are “different from, or in addition to” those imposed by federal law. Riegel, 552 U.S. at 321-22 (quoting 21 U.S.C. § 360k(a)(1)). Where the state requirements do relate to safety and effectiveness and are “different from, or in addition to” the requirements imposed by federal law, any claims for violation of those state requirements are expressly preempted. Id. at 330 (quoting and citing 21 U.S.C. § 360k(a)(1)). The express preemption provision “does not[, however, ] 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.” Riegel, 552 U.S. at 330 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996), and citing Lohr, 518 U.S. at 513).

         III. DISCUSSION

         As noted above, Bayer asks that we dismiss Count I (Negligent Training), Count II (Negligent Risk Management), Count III (Breach of Express Warranty), Count IV (Fraudulent Misrepresentation), and Count VI (Negligent Manufacturing).

         A. Count I - Negligent Training

          In Count I, the SAC asserts a claim for negligent training, essentially alleging that Bayer undertook a duty to train Plaintiffs' physicians, breached that duty by failing to abide by FDA training guidelines and requirements, and thereby caused Plaintiffs' injuries. (See SAC ¶¶ 118, 120, 123-24.) We previously dismissed with leave to amend the negligent training claim that Plaintiffs asserted in their prior Complaints. See McLaughlin, 172 F.Supp.3d at 816-818, 839-840. We explained that the claim was not expressly preempted under Riegel insofar as it alleged that Bayer failed to abide by FDA-approved training guidelines, but also observed that the claim, as pled in the prior Complaints, failed to state a claim upon which relief could be granted pursuant to Rule 12(b)(6) because it failed to specify how Bayer's training departed from such guidelines and also failed to articulate how any training failures caused any of the Plaintiffs' injuries. Id. at 816-818.

         The SAC now alleges six ways in which Bayer allegedly failed to abide by FDA-approved training requirements:

1. Failing to ensure that doctors successfully completed five preceptorings during training.
2. Failing to ensure that doctors read and understood the training manual.
3. Failing to ensure that doctors monitored patients through recovery.
4. Failing to ensure that doctors were knowledgeable hysterosocopists prior to the time they enrolled in the training program.
5. Failing to ensure that doctors successfully completed Essure simulator training.
6. Failing to ensure that doctors were certified under the preceding requirements.

(SAC ¶¶ 122-123.) The SAC further alleges that these “departure[s] from the training guidelines caused the Essure coils to migrate from the fallopian tube and caused . . . specific injuries” because the coils were improperly placed in Plaintiffs' fallopian tubes due to the training failures. (Id. ¶ 124.) Bayer argues that Count I should be dismissed because certain aspects of this claim are expressly preempted and the claim is otherwise subject to dismissal due to inadequate allegations of causation.

         1.Express Preemption

         Bayer argues that the negligent training claim is expressly preempted under Riegel insofar as it rests on allegations that Bayer failed to ensure that doctors (1) monitored their patients through recovery, (2) were knowledgeable hysteroscopists, and (3) were certified. As we discussed above, whether these aspects of the negligent training claim are, in fact, expressly preempted depends upon whether the alleged failings are violations of federal requirements or whether the claim seeks to impose requirements that are “‘different from, or in addition to'” federal requirements. See Riegel, 552 U.S. at 321-22 (quoting 21 U.S.C. § 360k(a)(1)).

         Plaintiffs maintain that all three of these alleged failings constitute violations of FDA-approved training requirements, which they assert are embodied in the Essure Physician Training Manual and Essure's Instructions for Use, and are conveyed to physicians, in part, during a didactic training course. Plaintiffs contend that the requirement that Bayer ensure that physicians be knowledgeable hysteroscopists is contained in Essure's Instructions for Use, which expressly state that Essure “should only be used by physicians who are knowledgeable hysteroscopists.” (Request for Judicial Notice (“RJN”) Ex. D at Bayer 0096.)[5] However, this particular warning cannot reasonably be construed as requiring that Bayer ensure that doctors are knowledgeable hysteroscopists prior to their engaging in Essure training. Plaintiffs have not identified any other federal directive that arguably requires Bayer to ascertain a doctor's qualifications prior to permitting the doctor to participate in Essure training. Accordingly, the SAC fails to allege facts sufficient to support the assertion that Bayer's failure to confirm that doctors are knowledgeable hysteroscopists prior to training violated a federal requirement. Instead, this claim plainly seeks to impose a different or additional requirement. We therefore conclude that the negligent training claim is expressly preempted insofar as it is grounded on a failure to ensure that doctors are knowledgeable hysteroscopists prior to training.

         Plaintiffs also contend that the requirement that Bayer ensure that physicians monitor their patients after implantation is contained in the Physician Training Manual, which directs that physicians conduct a follow-up with their patients three months after implantation of Essure. (See, e.g., RJN Ex. E § 8.) While the inclusion of this directive in the training manual may suggest that Bayer must train physicians to monitor their patients' conditions following implantation, it cannot reasonably be construed as requiring Bayer to police physician conduct after completion of training to ensure that the physicians are, in fact, monitoring their patients. Plaintiffs have not identified any other federal requirement that directs Bayer to monitor physician conduct post-training. Accordingly, we conclude that the SAC fails to support the assertion that Bayer's failure to monitor doctor conduct after the completion of training violated a federal requirement. We therefore conclude that Count I is expressly preempted insofar as it is grounded on an alleged failure to ensure that doctors monitor their patients after their completion of training.

         Plaintiffs further assert that there is a federal requirement that Bayer “certify” that doctors have successfully completed simulator training and five preceptorings, have read and understood the training manual, are knowledgeable hysteroscopists, and have monitored their patients through recovery. They argue that Bayer, through its representatives, has admitted that this is a federal requirement. (See Pls.' Resp. to Mot. to Dismiss (“Pls.' Resp. Br.”) Ex. A at 100; id. Ex. B at 16; id. Ex. C at 21.) However, Bayer's representatives simply stated that the company's didactic training includes signing off on a physician's capability. (See Pls.' Resp. Br. Ex. A at 100; id. Ex. B at 16; id. Ex. C at 21.) Plaintiffs have pointed to no federal requirement that specifically requires a formal certification process, much less certification that the trained physicians have met all of the requirements that Plaintiffs contend they must meet. Moreover, Plaintiffs have pointed to no authority for the proposition that we can find a federal certification requirement arising from statements made by Bayer representatives, when Plaintiffs are unable to identify a federally-approved document that sets forth such a certification requirement as a necessary component of Essure training. Accordingly, we conclude that the SAC fails to allege facts sufficient to support the assertion that Bayer's failure to certify doctors violated a federal requirement. We therefore conclude that Count I is expressly preempted insofar as it is grounded on Bayer's alleged failure to ensure that doctors are “certified.”

          2.Causation

         Bayer argues that we should dismiss the remaining aspects of Plaintiffs' negligent training claim because the SAC does not adequately allege that Plaintiffs' injuries were caused by Bayer's alleged failure to ensure that physicians had completed five preceptorings, had read and understood the training manual, and had successfully completed simulator training. See City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 422 n.9 (3d Cir. 2002) (noting that one element of a negligence claim is a causal connection between the breach of defendant's duty and plaintiff's resulting injury (citation omitted)). Specifically, Bayer contends that Plaintiffs' allegations of causation are boilerplate and do not suffice to plausibly link any alleged training failure to each Plaintiff's injuries.

         The SAC alleges that Bayer undertook responsibility for physician training insofar as it created a simulator called Essure and organized training courses at which Bayer trainers observed physicians until they believed the physicians were competent. (SAC ¶ 119.) The Physician Training Manual provides that the training requirements include “[s]uccessful completion of a Physician's Didactic Training Course” and “Essure Simulator Training, ” as well as “[c]ompletion of the initial procedures under the observation of a [Bayer] designated preceptor until competency in performing Essure is established (typically expected to be achieved in 5 cases).” (RFJ Ex. E at 2.) It further provides that “[u]pon successful completion of the initial training program, [a] Physician Training Record will be completed by a [Bayer] representative” . . . and “the physician's name will be added to the list of those trained to perform the procedure.” (Id.) The SAC alleges that Plaintiffs' implanting physicians did not complete the required preceptoring until competency, successfully complete the Essure Simulator Training, or understand the Physician Training Manual, and that Bayer negligently failed to ensure that these training requirements had been met. (Id. ¶ 123 (j)-(k), (n).) The SAC essentially alleges that, because Bayer departed from the required training by failing to ensure that physicians had successfully completed the required training, the physicians did not properly place the Essure device in Plaintiffs, and the device migrated from the fallopian tubes. (SAC ¶ 124.)

         We conclude that these allegations plausibly allege causation. While the SAC does not contain specific allegations regarding the particular physicians who performed the Plaintiffs' procedures, including precisely how the implantations were negatively affected by the physicians' inadequate training, these are facts that can be developed in discovery. Accordingly, we deny Bayer's Motion to the extent that it seeks dismissal of Plaintiffs' claim that Bayer negligently trained doctors by negligently failing to ensure both that doctors successfully completed Essure simulator training and five preceptorings, and that they read and understood the training manual.

         In sum, we conclude that the negligent training claim is expressly preempted insofar as it is grounded on Bayer's alleged failure to (1) confirm that doctors are knowledgeable hysteroscopists prior to training, (2) monitor doctors following their completion of training, or (3) ensure that doctors are “certified, ” and we grant the Motion to Dismiss as to Count I insofar as it relies on these alleged failures. However, we deny the Motion as to Count I insofar as it concerns Bayer's alleged failure to (1) ensure that doctors successfully completed five preceptorings during training, (2) ensure that doctors read and understood the training manual, and (3) ensure that doctors successfully completed Essure simulator training.

         B. Count II - Negligent Risk Management

          Count II of the SAC asserts a claim for negligent risk management. It alleges that Bayer is liable for breaching a “duty . . . to have in place a reasonable risk management procedure.” (SAC ¶ 132.) In our earlier Opinion in this case, we dismissed Plaintiffs' prior version of this claim with leave to amend. McLaughlin, 172 F.Supp.3d at 820-21, 840. We explained that a negligent risk management claim would not be expressly preempted under Riegel insofar as it alleged that Bayer violated federal risk management standards set forth in the Code of Federal Regulations, PMA and statutes. Id. at 820. We concluded, however, that we could not determine whether Plaintiffs' claims were expressly preempted because the Complaint failed to identify with any precision what federal risk management standards had been violated. Id. at 820-21. We further concluded that the Complaint failed to state ...


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