Full opinion text
MEMORANDUM Padova, Judge. Five individual Plaintiffs have initiated separate actions against Bayer Corp., Bayer Healthcare LLC, Bayer Essure, Inc., Bayer Healthcare Pharmaceuticals and Bayer A.G. (collectively, “Bayer”). Each action asserts twelve. claims for relief, seeking compensation for injuries that the Plaintiff suffered in connection with her use of Bayer’s female birth control device known as “Essure.” The five cases were consolidated for resolution of pre-trial motions.. In each of the five cases, Bayer has filed the same Motion for Judgment on the Pleadings Under Federal Rule of Civil Procedure 12(c), asking that we dismiss all of Plaintiffs’ claims either as expressly preempted, as impliedly preempted, because they fail to state a plausible or cognizable claim under Federal Rule of Civil Procedure 12(b)(6), or because they fail to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). We held oral argument on January 11, 2016. For the following reasons, we now grant the Motion in part and deny it in part, and also grant Plaintiffs the opportunity to file amended complaints. I. BACKGROUND The First Amended Complaint in the McLaughlin case (“Compl”) describes Es-sure as a female birth control device that “is intended ’ to cause bilateral occlusion (blockage) of the fallopian tubes by the insertion of micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage.” (Compl. ¶ 13.) “The micro-inserts are comprised of two metal boils which are placed in a woman’s fallopian tubes via Defendants’ disposable delivery system and under hysteroscopic guidance (camera).” (Id. ¶34.) The Complaint alleges that, instead of working as intended, “the device migrates from the tubes, perforates organs, breaks into pieces, and/or corrodes.” (Id. ¶ 13.) Each Complaint details specific injuries that the Plaintiff suffered after she had Essure implanted. In all five cases, the Essure device migrated from the Plaintiffs fallopian tubes to the Plaintiffs uterus, rectum or colon. In four of the five cases, the Plaintiff had to have a hysterectomy and, in the fifth case, the Plaintiff not only had her fallopian tubes removed, but also delivered a baby with birth defects. Al five Plaintiffs also experienced various additional symptoms, including severe pelvic or abdominal pain, bleeding, rashes, hair loss, insomnia, night sweats, fever, limb numbness, weight gain, vision problems, and/or fainting spells. Essure is a Class III medical device that required premarket approval by the Food and Drug Administration (the “FDA”). (Id. ¶¶ 46, 49.) The FDA separates medical devices into three categories, depending on their level of risk, and Class III devices receive the most federal oversight. Riegel v. Medtronic, Inc., 552 U.S. 312, 316-17, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). The Medical Device Amendments of 1976, . 21 U.S.C. § 360c et seq. (the “MDA”), which amended the Food, Drug and Cosmetic Act (“FDCA”), require new Class III devices to undergo a rigorous premarket approval process, which includes review of all known studies and investigations of the device’s safety and effectiveness. Riegel, 552 U.S. at 316-18, 128 S.Ct. 999. The FDA “grants premarket approval only if it finds that there is a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.’ ” Id. at 318, 128 S.Ct. 999 (quoting 21 U.S.C. § 36Qe(d)). Because the FDA weighs “ ‘any probable benefit to health from the use of the device against any probable risk of injury or illness from such use,’ ” it “may.. .'approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.” Id. (quoting 21 U.S:C. § 360c(a)(2)(C)). Following its review, the FDA may either grant approval, deny approval, or “condition approval on adherence to performance standards, restrictions upon sale or distribution, or compliance with other requirements.” Id. at 319, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(d), and 21 C.F.R. §§ 814.82, 861.1(b)(3)). “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specification, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id. (citing 21 U.S.C. § 360e(d)(6)(A)(i)). Indeed, “the FDA requires a device that has received premarket approval to be made with almost no- deviations from the specifications in its approval application, for the reason that the FDA has determined that approved form provides a reasonable assur-anee of safety and effectiveness.” Id. at 323, 128 S.Ct. 999. The Complaint alleges that the Essure device was first designed and manufactured by Conceptus, Inc. (Compl. ¶43.) Because it is a Class III medical device, Essure underwent the above-described scientific and regulatory review by the FDA to evaluate its safety and effectiveness. (Id. ¶49.) On November 4, 2002, Essure received conditional premarket approval (“PMA”) from the FDA. (Id. ¶ 15; 11/4/02 PMA letter (“PMA Ltr.”).) The PMA authorized Conceptus to begin commercial distribution of Essure in accordance with certain specified conditions, including that (1) the device be restricted to prescription use, (2) the labeling specify the requirements that apply to the training of practitioners that use the device, and (3) the sale, distribution and use not violate 21 U.S.C. § 352(q) and (r), which, inter alia, prohibit the use of false or misleading advertising and require all advertising or other descriptive matter to include certain information, such as alb relevant warnings, precautions, and side effects. (PMA Ltr. at 1.) The PMA also required Conceptus to conduct studies and collect data regarding pregnancies and outcomes, as well as adverse events, and to report its findings to the FDA annually. (Id. at 1-2.) In addition, it required Conceptus to conduct a study to document the bilateral placement rates for newly trained physicians, to permit an evaluation of training procedures and to update product labeling. (Id. at 2.) ■On April 28, 2013, Conceptus merged with Bayer, and Bayer now manufactures, sells, distributes, markets and promotes Essure. (Jd. ¶¶44, 46.) Bayer also trains physicians on how to use the device and how to implant the device using hystero-scopic equipment. (Id. ,¶¶ 47, 67.) Bayer’s training program included creation of a physician training manual; creation of a simulator called EssureSim; the organization of training courses, during which Bayer observed physicians until it believed they were competent; and creation of a Procedures Equipment Supplies checklist. (Id. ¶ 70.) Bayer also represented to Plaintiffs that “[pjhysicians must be signed-off to perform Essure procedures” and that Bayer kept training records of physicians who had been “signed-off” to perform the procedure. (Id. ¶¶ 70, 72.) The Complaint further alleges, among other things, that Bayer’s training of physicians was inadequate and that Bayer provided the hysteroscopic equipment to implanting physicians who were not qualified or competent to use the equipment. (Id. ¶ 66.) The Complaint further alleges that Bayer engaged in an unreasonably dangerous distribution plan aimed solely at capturing market share, insofar as it, inter aha, provided unqualified physicians with specialized hysteroscopic equipment and required implanting physicians to purchase two Essure kits a month, whether or not they used the kits. (Id. ¶¶ 77-80.) According to the Complaint, Bayer made several statements about Essure, in several different contexts, that were false and/or misleading and which constituted warranties. For example, on its website, Bayer falsely stated that Essure is “Worry free: once your doctor confirms that your tubes are blocked, you never have to worry about unplanned pregnancy,” and that only skilled operative hysteroscopists would be trained to implant' Essure. (Id. ¶ 103(e), (]').) Likewise, in its advertisements, Bayer falsely stated, among other things, that, “[i]n order to be identified as a qualified Essure physician,” a physician must perform “a minimum of one Essure procedure.. .every 6-8 weeks.” (Id ¶ 104(b).) Bayer also prepared a brochure for Essure that included false statements, including that Essure is “Worry free/’ stays secure, and is made from..“the same trusted, silicone free material used in hearts stents.” (Id. ¶ lll(a)-(c).). The Complaint also alleges that Bayer failed to report all adverse events to the FDA, as the PMA required. Among other things, the Complaint alleges that Bayer failed to report eight perforations that occurred, instances of migration, and 16,047 unspecified complaints about the device. (See, e.g, id, ¶¶ 58(c)-(d), (g), 59(e), lll(a)(vi), (b)(ii).) It also alleges that Bayer had notice of 168 perforations but only disclosed 22 to the FDA. (Id. -¶ 60(b). The Complaint further alleges (and purports to document with an exhibit) that, on multiple occasions in 2010, Bayer failed to timely report to the FDA incidents involving perforation, the Essure coil breaking into pieces, and Essure migration. (Id. ¶¶ 60(a), lll(a)(viii), and Ex. F).) ■ Each of the five .Complaints asserts twelve causes of action. Count I of each Complaint alleges that Bayer negligently trained Plaintiffs’ implanting physicians. (Id. ¶ 125.) Count II alleges that Bayer negligently entrusted the hysteroscopic equipment to Plaintiffs’ implanting physicians. ■ (Id. ¶ 141.) Count III alleges a claim for “Pharmaeovigilance-Negligent Distribution/Advertising/Overpromotion/Reporting” stemming from Bayer’s allegedly “unreasonably dangerous distribution, advertising, promotion and reporting plan.” (Id ¶ 151.) Count IV alleges a claim for negligent risk management, asserting that Bayér breached its duty to engage in reasonable risk management, insofar as it failed to notify the FDA of adverse reports, track non-conforming products, and consider adverse reports in its risk analysis. (Id. ¶ 162.) Count V alleges that Bayer breached express warranties. (Id. ¶¶ 179, 184.) Count VI alleges that Bayer violated Pennsylvania’s Unfair Trade Practices and Consumer Protection Law (“UTPCPL”), 73 Pa. Stat. Ann. § 201-1 et seq., by engaging in deceptive conduct. (Id. ¶ 194.) Count VII asserts a claim for fraudulent concealment insofar as. Bayer failed to disclose to Plaintiffs and their implanting physicians various complaints about the device and the device’s non-compliance with FDA standards. (Id. ¶ 206.) Counts VIII and IX allegé claims of fraudulent misrepresentation and negligent misrepresentation with respect to Bayer’s statements about Es-sure. (Id. ¶¶ 217, 230.) Count X asserts a strict liability claim, based on an assertion that Essure was unreasonably dangerous insofar as it did not comply with federal law and the PMA, and did not contain adequate warnings and s'afety devices to prevent harm to consumers. (Id. ¶¶242-44.) Count XI alleges that Bayer negligently manufactured Essure by failing to manufacture the device in conformance with FDA specifications, federal regulations, and PMA requirements. (Id. ¶ 268.) Count XII asserts that Bayer negligently failed to warn Plaintiffs and the-implanting physicians as required by federal law and the PMA of the risks of the device and manufacturing defects. (Id. ¶ 277.) II. LEGAL STANDARDS A. Motions for Judgment on the Pleadings Under Federal Rule of Civil Procedure 12(c), “[a]fter the pleadings are closed— but early enough not to delay trial — a party may move for judgment on the pleadings.” Fed, R. Civ. P. 12(c). Rule 12(c) motions based on the theory that the plaintiff has failed to state a claim are reviewed under the same pleading standards that apply to motions to dismiss for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6). Revell v. Port Auth., 598 F.3d 128, 134 (3d Cir.2010) (citation omitted); Spruill v. Gillis, 372 F.3d 218, 223 n. 2 (3d Cir.2004). 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 undis-putedly 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, — U.S. -, 134 S.Ct. 2056, 2065 n. 5, 188 L.Ed.2d 1039 (2014) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (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, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (alteration in original) (quoting Conley v. Gibson, 355 U.S. 41, 47, 78 S.Ct. 99, 2 L.Ed.2d 80 (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, 129 S.Ct. 1937 (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955). “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) (quoting Iqbal, 556 U.S. at 678, 129 S.Ct. 1937). “ ‘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, 129 S.Ct. 1937). 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, 127 S.Ct. 1955). B. Federal Preemption 1. Express Preemption The MDA expressly preempts 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 the controlling case of Riegel v. Medtronic, Inc, the Supreme Court articulated this provision as setting forth a two-step analysis for determining whether a claim is expressly preempted. 552 U.S. at 321-22, 128 S.Ct. 999. First, the court must ascertain whether the federal government has established requirements applicable to the medical device at issue. Id. Riegel concluded, however, 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, 128 S.Ct. 999 (“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, 128 S.Ct. 999)). 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, 128 S.Ct. 999 (quoting 21 U.S.C. § 360k(a)(l)). 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 323, 330, 128 S.Ct. 999 (quoting and citing.21 U.S.C. § 360k(a)). The Third Circuit has indicated, albeit in a pre-Riegel opinion, that “a court should carefully examine the state common law claim in order to determine whether that claim would impose -a substantive requirement that conflicts with,' or'adds a greater burden to, a specific ‘federal- requirement.” Horn v. Thoratec Corp., 376 F.3d 163, 174 (3d Cir.2004) (citing Mitchell v. Collagen Corp., 126 F.3d 902, 911-12 (7th.Cir.1997); Kemp v. Medtronic, 231 F.3d 216, 230 (6th Cir.2000); and Martin v. Medtronic, 254 F.3d 573, 581-83 (5th Cir.2001)). 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, 128 S.Ct. 999 (quoting Lohr, 518 U.S. at 495, 116 S.Ct. 2240, and citing Lohr, 518 U.S. at 513, 116 S.Ct. 2240). 2, Implied Preemption The Supreme Court has held that, in addition to providing for express preemption, the FDCA and MDA impliedly preempt state law claims .that amount to “fraud-on-the-FDA claims.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). In Buckman, the Court noted that § 337(a) of the MDA provides that ‘“all.. .proceedings for the enforcement, or to restrain violations, of [the MDA] shall be by and in the name of the United States,’ ” id. at 349 n. 4, 121 S.Ct. 1012 (quoting 21 U.S.C. § 337(a)), and specifically empowers the FDA to investigate, punish and deter fraud against it. Id. at 349, 121 S.Ct. 1012 (citing 21 U.S.C. §§ 332 (providing for injunctive relief), 333(f)(1)(A) (providing for civil penalties), 333(a) (providing for criminal prosecutions), 334(a)(2)(D) (allowing seizure of the device), and 372 (authorizing the FDA to conduct investigations)) (additional citations. omitted). The Court essentially reasoned that state law fraud claims that “exist solely by virtue of the FDCA disclosure requirements,” id at 353, 121 S.Ct. 1012, necessarily “conflict with the FDA’s responsibility to police such violations consistently with the Administration’s judgment and objectives.” Id. at 350, 121 S.Ct. 1012. It therefore concluded that where claims arise “solely from the violation of FDCA requirements,” they are impliedly preempted. Id at 352-53, 121 S.Ct. 1012. At the same time, the Court made clear that a claim that “rel[ies] on traditional state tort law which. . .predated the federal enactments in question! ]” is not preempted. Id. at 353, 121 S.Ct. 1012. The United States Court of Appeals for the Eighth Circuit has observed that, together, “Biegel and Buckman create a narrow gap- through which a plaintiffs state-law claim must fit if- it is to escape express or 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).” In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir.2010). (quoting Riley v. Cordis Corp., 625 F.Supp.2d 769, 777 (D.Minn.2009)). III. DISCUSSION. Bayer’s Motion for Judgment'.on the Pleadings asks that we. dismiss all twelve Count? of each Complaint pursuant to Rule 12(c), either based on express preemption, implied preemption, failure to state a plausible claim under the Rule 12(b)(6) pleading standards, or failure to plead fraud' with particularity as required by Rule 9(b). Plaintiffs contend that none of these arguments support the dismissal of any of their claims. They further request that, if we dismiss any of their claims, we also grant them leave to amend their Complaints to cure any deficiencies that we have identified. We address each Count of the Complaint in turn, although not entirely in sequential order. A. Count I — Negligent Training In Count I, the Complaint alleges that Bayer is liable on a, claim for negligent training insofar as it (1) “fail[ed] to abide by the FDA training guidelines with Plaintiffs implanting physician,” e.g., providing “training [that was] different from that of the ‘Physician Training Manual;’ ” (2) “fail[ed] to supervise the procedure;” (3) “fail[ed] to train Plaintiffs physician on how to use the hysteroscopic equipment;” and (4) “fail[ed] to advise implanting physicians of the adverse events and non-conforming product.” (Compl. ¶ 125.)' The Complaint further alleges that “[t]his breach caused Plaintiffs damages” insofar as the Essure device migrated from Plaintiffs fallopian tubes and caused various complications. (Id. ¶ 126.) Bayer argues that Plaintiffs’ negligent training claim should be dismissed as expressly preempted because Plaintiffs seek to impose training requirements different from those in the federal requirements. It further argues that, to the extent that Plaintiffs’ claim purports to seek enforcement of federal training requirements, it is •impliedly preempted under Buekman because there is no state law duty to engage in the training that Plaintiffs contend should have been done. Finally, it argues that the Count fails to state a plausible claim because, inter alia, it does not include any specific allegation as to how Plaintiffs’ damages are tied to the alleged violation of state law. ' 1. Preemption Upon consideration of Bayer’s preemption arguments, we conclude that, at least to the extent that the claim alleges that Bayer failed td abide by FDA-approved training violations, the negligent training claim does not seek to impose training requirements different from those in the federal requirements and, thus, is not expressly preempted on that basis but, rather, asserts a permissible parallel claim. See Riegel, 552 U.S. at 330, 128 S.Ct. 999 (stating that express preemption provision “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements” (citation omitted)). Moreover, we reject Bayer’s argument that the negligent training claim is impliedly preempted because there is no state law on which to base a negligent training claim. Instead, we conclude that Pennsylvania, law, recognizes that, in certain contexts, one who undertakes to render services to another may.be subject to liability to a third party for failure to exercise due care in rendering those services, when the services were necessary for the protection of that third party. See Seebold v. Prison Health Sys., Inc., 618 Pa. 632, 57 A.3d 1232, 1244-45 (2012) (citing Restatement (Second) of Torts § 324A (1965)); see also Myers v. Garfield & Johnson Enters., Inc., 679 F.Supp.2d 598, 616 (E.D.Pa.2010) (citations omitted). Accordingly, we deny Bayer’s request that we dismiss Plaintiffs’ negligent training claims on preemption grounds. 2. Plausibility Bayer argues in the alternative that we should dismiss the negligent training claim for failure to state a claim upon which relief can be granted. In order to state a negligence claim under Pennsylvania law, a plaintiff must allege (1) a duty owed to the plaintiff by the defendant; (2) a breach of that duty; (3) a causal connection between the breach and the resulting injury; and (4) actual loss or damages. City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 422 n. 9 (3d Cir.2002) (citing Martin v. Evans, 551 Pa. 496, 711 A.2d 458, 461 (1998)); Davenport v. Medtronic, Inc., 302 F.Supp.2d 419, 439 (E.D.Pa.2004) (citing Morena v. S. Hills Health Sys., 501 Pa. 634, 462 A.2d 680, 684 n. 5 (1983)). Reading the Complaint in the light most favorable to Plaintiffs, it alleges that Bayer, by training Plaintiffs’ physicians, assumed a duty to do so non-negligently; that Bayer breached that duty by failing to follow the FDA-imposed training guidelines; and that Plaintiffs’ injuries, all of which are alleged-to have arisen from the migration of the Essure device from Plaintiffs’ fallopian tubes, were caused by Bayer’s training deficiencies. However, the Complaint does not allege how Bayer’s training departed from the FDA-approved guidelines, much- less any facts that give rise to a recognizable theory as to how any departure from the training guidelines may have caused each Plaintiffs Essure device to migrate from her fallopian tubes. Plaintiffs asserted at oral argument that they were unable to plead their negligent training claim with greater specificity because they do not know what the federal requirements are with respect to training. (See N.T. .1/11/16 at 21, 33-34, 36.) However, at the same time, the Complaint alleges that the training provided -was different from that set forth in the “Physician Training Manual” (Compl. ¶ 125), and Plaintiffs admitted at argument that they had a copy of that manual (N.T. 1/11/16 at 36). Accordingly, Plaintiffs’ assertion that they did not have , the ability to plead with greater specificity that the training provided to Plaintiffs’ doctors departed from the training standards is unfounded. We conclude that the Complaint’s bald allegations of both negligence and causation do nothing more -than posit a “sheer possibility that [Bayer] has acted, unlawfully,” without setting forth a plausible claim of negligent training. Iqbal, 556 U.S. at 678, 129 S.Ct. 1937; see also Connelly, 809 F.3d at 786. Accordingly, we conclude that Count! fails to state a claim upon which relief can be granted and dismiss Count I on that basis. B. Count II — Negligent Entrustment. In Count II, the Complaint alleges that Bayer is liable because it negligently entrusted specialized hysteroscopic - equipment to physicians who were not qualified or competent to use that equipment. (Compl. ¶¶ 133-34; see also id. ¶¶ 73, 77.) The Complaint-alleges that Bayer had a duty not to provide sophisticated equipment to unqualified - physicians; that it knew that Plaintiffs’ implanting physicians were not qualified to use the hysteroscopic equipment; that it nevertheless provided the equipment to the physicians; and that Plaintiffs were injured as a result of the negligent entrustment- insofar as the Es-sure device migrated from Plaintiffs’ fallopian tubes. (Id. ¶¶ 140-45.) Bayer argues, among other things, that this Count should be dismissed because Plaintiffs’ negligent entrustment claim is pre-empted under Riegel. Specifically, Bayer argues that, in light of the Essure PMA, Plaintiffs’ claim against it, for negligent entrustment of hysteroscopes is expressly preempted because Plaintiffs seek to impose requirements that are “different from, or in addition to” federal requirements concerning Essure’s safety.. In that regard, Bayer notes that the PMA expressly sets forth certain training requirements and protocols for physicians who use Essure and does not require Bayer (or any other hysteroscope provider) to do anything more than what the PMA requires. It argues that the FDA expressly approved Instructions for Use that contained (1) a warning that Essure is to be “used only by physicians who are knowledgeable hysteroseopists,... and have successfully completed the Essure training program,” as well as (2) instructions regarding the use of a hysteroscope to implant Essure. Bayer therefore contends that Plaintiffs cannot proceed' on any negligent entrustment claim that imposes a requirement that Bayer not entrust hys-teroscopy equipment to unqualified physicians; it reasons that, pursuant to the PMA process, the FDA has determined that the safeguards that it has put in place for the implantation of Essure aré sufficient and, under express preemption principles, the state cannot impose safety requirements that would be “different from, or in addition to” the requirements that the FDA imposed. In response to this argument, Plaintiffs maintain that their claim is outside the scope of any such federal preemption because it concerns the safety of the, hystero-scopic equipment, not the safety of Essure, and the PMA concerned only Essure, not hysteroscopes. In this regard, they argue that the alleged entrustment has “absolutely nothing to do with Essure and the product of Essure,” emphasizing that hysteroscopic equipment is “very specialized” and dangerous in its own.right, such that “if you use[ ] it wrong, you can actually kill somebody.” (N.T. 1/11/16 at 37.) However, we cannot reconcile this characterization of the claim with the allegations of the’ Complaint, because the Complaint plainly alleges that Bayer was negligent in entrusting the hysteroscope to Essure-implanting physicians, that Bayer’s motivation was to increase sales of the Essure device, and, most importantly, that the damage that flowed from this alleged negligent entrustment was that Plaintiffs’ Essure device migrated following implantation, not that Plaintiffs were'injured by the hysteroscope itself. ■ (Compl. ¶¶ 133, 135, 141-42.) As such, we cannot read the Complaint to assert a claim concerning hysteroscopes that is divorced from the safety of Essure. Rather, we can only conclude that the claim, as pled,- seeks to impose a state requirement relating to the safety of Essure (i.e., a requirement that suppliers not provide hysteroscopic equipment to Essure-implanting physicians who are not competent hysteroscopists), which is in addition to the FDA’s own safety requirements and, therefore, is expressly preempted under Riegel. Moreover, the negligent entrustment claim is not based on state 'law that- imposes duties that “ ‘parallel,’ rather than add to, federal requirements.” Riegel, 552 U.S. at 330, 128 S.Ct. 999 (allowing that a state law claim premised on duties- that parallel rather than add to federal requirements is not expressly preempted (citation omitted)). We thus dismiss Count II for failure to state-a claim upon which relief can be granted because it is expressly preempted, and we deny Plaintiffs leave to amend this claim because we conclude that its express preemption renders it futile. C. Count IY — Negligent Risk Management Count IV of the Complaint alleges that Bayer is liable for breaching a “duty to have in place a reasonable risk management procedure” that ensured that nonconforming products could be tracked appropriately, and that adverse reports were considered in its risk analysis. (Compl. ¶ 162.) Bayer argues that this claim should be. dismissed as expressly preempted pursuant to Riegel, because all risk management is plainly and comprehensively regulated by the FDA insofar as the PMA specifically requires the reporting of events involving safety and efficacy and any state law concerning risk management would' add to those federal requirements. Bayer further argues that Count IV fails to state a claim upon which relief can be granted because Plaintiffs do not identify any state law that creates a' tort for negligent risk management and there is, in fact, no parallel state law that provides for liability for violations of the FDA risk, management protocols. Pennsylvania law, however, permits plaintiffs considerable latitude in labeling their negligence claims, and we conclude that it would recognize a claim for negligent risk management. As the Pennsylvania Supreme Court has made clear, plaintiffs are the “master[s] of [their] own claim[s].” Lance v. Wyeth, 624 Pa. 231, 86 A.3d 434, 460 (2014). Moreover, the Pennsylvania Supreme Court has quoted with apparent approval an amicus brief which states that: “A manufacturer’s negligent conduct can occur at any stage of the marketing process: in the initial design of the [product], in the failure to investigate information about the risks the [product] poses, and in its decision to continue to sell .the [product] despite those unreasonable risks. The defendant’s unreasonable behavior at any point in this process should be sufficient to give rise to negligence. liability when that conduct results in injury.” Id. at 468 (emphases added) (quoting Br. for Amici Am. & Pa. Ass’ns for Justice at 3). As such, we reject.Bayer’s argument that Pennsylvania would not recognize a claim for negligent risk management. Moreover, while Bayer maintains that any .such claim is expressly preempted because Plaintiffs seek to impose different or additional standards from those imposed by the FDA, as we read the Complaint, Plaintiffs only seek to hold Bayer to federal risk management standards as articulated in the Code of Federal Regulations, the PMA, and federal statutes. Accordingly, at this time, we cannot conclude that Plaintiffs are seeking to pursue anything other than a-permissible parallel claim. Nevértheless, the scope of the parallel claim that Plaintiffs seek to pursue and the elements of that claim are insufficiently pled and we therefore dismiss this claim on that basis. As an initial matter, we observe that it is impossible to discern from the Complaint precisely what federal standards are allegedly violated by each alleged violation of risk management standards, because Count IV simply includes a laundry list of over twenty-five federal “requirements,” and then alleges over twenty alleged breaches-of Bayer’s risk management duties, without giving any indication as to what federal requirement was violated by each alleged breach. (See Compl. ¶¶ 162(a)-(z), 163(a)-(w).) Moreover, certain of the alleged breaches do not appear to have any identifiable relation to “risk management,” such as allegations that. Bayer issued untruthful warranties, .failed to use pre-sterile and post-sterile eages during manufacturing, and required physicians to purchase two Essure kits a month. (Id. ¶ 163(e), Ci),(v).) Most importantly, however, Plaintiffs have failed to allege any identifiable causal connection between the alleged risk management breaches and Plaintiffs’ resulting injuries. See Beretta U.S.A. Corp., 277 F.3d at 423 (requiring plaintiff to allege “some direct relation between the injury asserted and the injurious, conduct alleged” (citation and internal quotation marks omitted)). For example, the Complaint appears to allege that Bayer violated state and federal risk management standards in 2003 by failing to follow manufacturing procedures to control products that did not conform to specifications, and by failing to identify existing and potential causes of non-conforming product. (Compl. ¶ 163(t), (u).) The Complaint then baldly alleges that all identified risk management breaches caused Plaintiffs’ damages insofar as the Essure device migrated from Plaintiffs fallopian tubes. (Id. ¶ 170.) Given the lack of allegations that in any way link Bayer’s failure to follow procedures in 2003 with the migration of any of Plaintiffs’ Essure devices between 2008 and 2013, we can only conclude that Plaintiffs’ claims are based entirely on speculation. Indeed, we are unable to discern any plausible and non-speculative causal connection between any of Bayer’s alleged risk management failings and the migration of Plaintiffs’ Essure devices. See Twombly, 550 U.S. at 556, 127 S.Ct. 1955 (requiring complaint to set forth “sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face” (quotation omitted)). Accordingly, we conclude that the negligent risk management claim, as currently pled, does not set forth a plausible claim for relief, and we dismiss Count IV on that basis. D. Count V — Breach of Express Warranty Count V of the Complaint alleges that Bayer is liable for breaching express warranties. Specifically, the Complaint alleges that Bayer breached numerous express warranties with Plaintiffs, including: • warranties on its.website that erroneously stated, inter alia, that Physicians “must be signed-off to perform Essure procedures,” that Essure is “Worry free,” and that Essure is “more effective than tying your tubes”; ■ • warranties in its advertisements that erroneously stated that physicians would not be “qualified” as Essure physicians unless they performed the Essure procedures at least once every 6-8 weeks; • a marketing warranty that Essure allows for ' “visual confirmation of each insert’s proper placement,” when it does not; • warranties in brochures that erroneously state, inter alia, Essure is “Worry free,” stays secure and remains visible outside a user’s tubes, so that .a doctor can confirm its proper placement, and is made from the same silicon-free materials used in heart stents; , • warranties in the Essure booklet that Essure is painless, and does not irritate the uterine lining. (See Compl. ¶¶ 103-115.) The Complaint alleges that all of these warranties “were specifically negotiated and expressly communicated to Plaintiffs] in such a manner that [they], understood and accepted them” (id. ¶ 182 (emphases added)), and that Plaintiffs relied on the warranties prior to implantation (id. ¶ 102). Finally, the Complaint alleges that, as a result of Plaintiffs’ reliance on the warranties, they suffered damages, i.e., the device migrated and Plaintiffs suffered a variety of complications and other injuries. (Id. ¶ 183.) Bayer argues that this claim should be dismissed as expressly preempted because Plaintiffs seek to impose requirements that are different from federal requirements. It also argues that the claim fails to state a plausible claim for relief under the requisite pleading standards. 1, Express Preemption Pursuant to Riegel’s express preemption analysis, we must consider whether Plaintiffs’ breach of warranty claim relies on state . requirements that are “different from, or in addition to” federal requirements. Riegel, 552 U.S. at 330, 128 S.Ct. 999 (quoting 21 U.S.C..§ 360k(a)(l)). Plaintiffs, argue that their claim is not expressly preempted because it is not based on state requirements but, rather, is grounded on voluntary contractual promises made by Bayer. Plaintiffs are correct that “[express warranties, as distinguished from implied warranties, do not independently arise by operation of state law.” Bentzley v. Medtronic, Inc., 827 F.Supp.2d 443, 454 (E.D.Pa.2011). Pennsylvania law provides that an express warranty is “specifically negotiated,” Goodman v. PPG Indus., 849 A.2d 1239, 1243 (Pa.Super.Ct.2004), and “is created by a seller through ‘[a]ny affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain.’ ” Starks v. Coloplast Corp., Civ. A. No. 13-3872, 2014 WL 617130, at *6 (E.D.Pa. Feb. 18, 2014) (quoting 13 Pa. Cons. Stat. § 2313). Thus, “the parties, not the state, ‘défine[] the substantive obligations of the contract and hence any express warranties.’ ” Bentzley, 827 F.Supp.2d at 454-55 (alteration in original) (quoting Michael v. Shiley, Inc., 46 F.3d 1316, 1325 (3d Cir.1995)), abrogated on other grounds by Lohr, 518 U.S. 470, 116 S.Ct. 2240. Consequently, a “claim for breach of express warranty does not involve a state ‘requirement’ and is not preempted by MDA.” Id.; see also Hofts v. Howmedica Osteonics Corp., 597 F.Supp.2d 830, 839 (S.D.Ind.2009) (“Because express warranties ‘arise from the representations of the parties and are made on the. basis of the bargain between them,’ a ‘state judgment based on the breach of an express representation by one of the parties does not necessarily interfere with the operation of the PMA’ and therefore may not be preempted.” (quoting Mitchell v. Collagen Corp., 126 F.3d 902, 915 (7th Cir.1997)). In accordance with this analysis, we conclude that Plaintiffs’ breach of warranty claim is not expressly preempted because, as pleaded, it does not arise from state “requirements,” but rather arises from alleged contracts between the parties. 2. Plausibility Bayer argues in the alternative that the breach of warranty claim should be dismissed for failure to state a plausible claim because the Complaint does not include allegations as to “the source of the statements, when the statements were made, in what manner the statements were made, the Defendants’ alleged intended recipient, when Plaintiffs became aware of the statements,” or “how the alleged warranties ended up as the basis for an alleged and unspecified bargain between the parties.” (Bayer’s Reply Br. at 45-46.) As stated above in Section II.A, supra, “[a] claim has facial plausibility when the plaintiff pleads factual content that allows a court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (citation omitted). “[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.” Esposito v. I-Flow Corp., Civ. A. No. 10-3883, 2011 WL 5041374, at *6 (E.D.Pa. Oct. 24, 2011) .(citation and internal quotation marks omitted). Rather, a plaintiff must allege that defendant made “an actual affirmation of fact or a promise, [which] formed the basis of the bargain between the [defendant] and the plaintiff.” Jeter v. Brown & Williamson Tobacco Corp., 113 Fed.Appx. 465, 468 (3d Cir.2004) (citing 13 Pa. Cons. Stat. § 2313 and Goodman, 849 A.2d at 1243)); see also Esposito, 2011 WL 5041374, at *6 (citations omitted). Moreover, where a breach of warranty claim is based on advertisements, the plaintiff can only establish reliance if he “ ‘actually saw or heard and believed the allegedly false advertisements.’'” Jeter, 114 Fed.Appx. at 469 (quoting Weinberg v. Sun Co., Inc., 565 Pa. 612, 777 A.2d 442, 446 (2001)); see also Parkinson v. Guidant Corp., 315 F.Supp.2d 741, 752 (W.D.Pa.2004) (stating that, in order 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” (quoting Cipollone v. Liggett Group, Inc., 893 F.2d 541, 567 (3d Cir.1990)), rev’d on other grounds, 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992). Here, the Complaint pleads the substance of the alleged warranties, explicitly quoting most of them. (See Compl. ¶¶ 103-15.) It also alleges the mode of communication for each warranty (e.g., advertisement, website, brochure) (see id.), and suggests that Plaintiffs encountered the warranties either on the internet, in their physicians’ offices, on Bayer’s website, or through Bayer’s advertising (see id. ¶ 102). However, the Complaint fails to allege any of the circumstances under which each Plaintiff read or saw each particular warranty, or how that-warranty came to be a basis of each Plaintiffs bargain with Bayer. Instead, it includes only the wholly conclusory allegations that warranties were “specifically negotiated and expressly communicated to Plaintifffs] in such a manner that Plaintiffis] understood and accepted them,” and that the affirmations of fact or promises in the warranties “created a basis of the bargain” between Plaintiffs and Bayer. (Id. ¶¶ 181-82.) The following examples illustrate the Complaint’s insufficiencies. While the Complaint alleges that certain warranties appeared in advertisements and ‘marketing, it does not.allege whether the advertisements appeared in magazines, newspapers or other publications, on posters, on the internet, or on the television. (Id. ¶¶ 104,110.) In addition, insofar as it alleges that other warranties came from Bayer’s brochures (id. ¶ 111), it does not allege the titles of, or any other identifying information for, the alleged brochures. The Complaint also fails to allege how or when each Plaintiff encountered each warranty beyond alleging the general time frame of “prior to implantation,” which covers a period of many years. (Id. ¶ 102.) The Complaint also-does not allege sufficient facts concerning the sources of many warranties, so as to support a reasonable inference that all of the warranties were actually directed to, and intended for, patients such as Plaintiffs. Indeed, one of. the. alleged warranties on Bayer’s website states that “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.. (id. ¶ 103(j)), which, on its face, does not appear to be directed to patients such as Plaintiffs. In addition, at least one warranty, on its face, does not appear to be an affirmation of fact or promise that could give rise to an express warranty. (Id. ¶ 104(d) (“I don’t want to worry about an unexpected pregnancy.”).) In short, the Complaint fails 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 the bargain” between Bayer and each Plaintiff. See Starks v. Coloplast Corp., Civ. A. No. 13-3872, 2014 WL 617130, at *7 (E.D.Pa. Feb. 18, 2014) (dismissing breach of warranty claim pursuant to Rule 12(b)(6), in part because it did not allege “any details regarding.. .how the warranty was made, that it became the basis of the bargain, or that it was directed to [plaintiff]”). Indeed, there are no meaningful allegations concerning- the circumstances under which the alleged warranties were “specifically negotiated” with Bayer, and “expressly communicated” to each Plaintiff (id. ¶ 179), such that we can reasonably infer that the warranties became a matter of contract between each Plaintiff and Bayer. See Bentzley, 827 F.Supp.2d at 454-65 (“[T]he parties... define!] the substantive obligations of the contract and hence any express warranties.” (quotation omitted)). We therefore conclude that the bald allegation that the warranties “created a basis of the bargain” is nothing more than a “conclusory recitation” of an element of the cause of action, which is. insufficient to plead the existence of an express warranty. Esposito, 2011 WL 5041374, at *6. Under these circumstances, we conclude that the Complaint does not contain “ ‘sufficient factual matter to show that the [breach of express warranty] claim is facially plausible,’ thus enabling ‘[us] to draw the reasonable inference that the defendant is liable for [the] misconduct alleged.’ ” Warren Gen. Hosp., 643 F.3d at 84 (quoting Fowler, 578 F.3d at 210). We 'therefore conclude that Count V fails to allege a plausible breach of express warranty claim, and we dismiss it on that basis. E. Count VII — Fraudulent Concealment Count VII of the Complaint alleges that Bayer is liable for fraudulent concealment because it actively concealed adverse events involving Essure, as well as manufacturing irregularities and . complaints about the product, from both Plaintiffs and their physicians to induce Plaintiffs to have Essure implanted. Specifically, the Complaint alleges that Bayer had a duty to make certain disclosures pursuant to federal law and the Essure PMA and that it intentionally breached those ' duties. (Compl. ¶¶ 205-07.) Bayer argues, inter alia, that Count VII should be dismissed as impliedly preempted under Buckman. Specifically, Bayer argues that the fraudulent concealment claim is actually a preempted “fraud-on-the-FDA” claim, because Bayer’s alleged duty to disclose is a federal duty to disclose information to the FDA. As discussed in Section II.B.2, supra, the Supreme Court held in Buckman that “fraud-on-the-FDA” claims, which “exist solely by virtue of FDCA disclosure requirements,” are solely within the authority of the FDA to punish and deter. 531 U.S. at 348, 350, 353, 121 S.Ct. 1012. Thus, where a plaintiff sues “because the conduct violates the FDCA,” it is impliedly preempted under Buckman. Sprint Fidelis, 623 F.3d at 1204 (emphasis in original) (quotation omitted). In order to state a cognizable claim for fraudulent concealment under Pennsylvania law, a plaintiffs claim must rest on a duty to disclose, as “there can be no liability for fraudulent concealment absent some duty to speak.” City of Rome v. Glanton, 958 F.Supp. 1026, 1038 (E.D.Pa.1997) (citing Duquesne Light Co. v. Westinghouse Elec. Corp., 66 F.3d 604, 611-12 (3d Cir.1995); Gibbs v. Ernst, 538 Pa. 193, 647 A.2d 882, 889 n. 12 (1994); and In re Estate of Evasew, 526 Pa. 98, 584 A.2d 910, 913 (1990)); see also Restatement (Second) of Torts § 551(2) (providing that omissions can give rise to valid claims of fraud only when the defendant had a duty to disclose the ‘ omitted information). “Moreover, [under Pennsylvania law], a duty to disclose does not typically arise unless there is a confidential or fiduciary relationship between the parties.” Protica, Inc. v. iSatori Techs., Inc., Civ A. No. 11-1105, 2012 WL 1071223, at *5 (E.D.Pa. Mar. 30,2012) (citation omitted). The Complaint in this case alleges only that federal law and the PMA imr posed a duty to speak by requiring Bayer to disclose certain information to the FDA. (See, e.g., Compl. ¶ 205(a), (b), (c), (d), (e), (f), (k), (l), (v), and (w) (referencing federal law mandating disclosures to the FDA).) It does not allege that Pennsylvania law imposed any duty on Bayer to disclose the allegedly undisclosed information, much less a duty to disclose such information to Plaintiffs and/or their physicians. As such, Plaintiffs’ fraudulent concealment claim, as pled, exists “solely by virtue of FDCA requirements.” Buckman, 531 U.S. at 353, 121 S.Ct. 1012. Plaintiffs argue that their fraudulent concealment claim is not. subject to implied preemption for the same reasons that their negligent failure to warn claim is not subject to such preemption, see infra, Section III.J., thereby suggesting that their fraudulent concealment claim is partially grounded on a state law duty to warn. However, as noted above, the Complaint itself alleges only violations of federal duties to disclose. Moreover, to the extent that Plaintiffs intended to ground their fraudulent concealment claim on a state law duty to warn that parallels the federally-imposed disclosure duties, it would fail to state a claim upon which relief can be granted because “negligence is the sole theory upon which a plaintiff may recover against a prescription drug- [or medical device] manufacturer for a failure to warn.” Kline v. Pfizer, Inc., Giv. A. No. 08-3238, 2009 WL 32477, at *4 (E.D.Pa. Jan. 6, 2009) (citing Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 891 (1996)); see also Runner v. C.R. Bard, 108 F.Supp.3d 261, 268-69 (E.D.Pa.2015); Kester v. Zimmer Holdings, Inc., Civ. A. No. 10-523, 2010 WL 4103553, at *4 (W.D.Pa. Oct. 18, 2010) (citing Kline v. Pfizer, Inc., Civ. A. No. OS-3238, 2009 WL 32477, at *4-5 (E.D.Pa. Jan. 6, 2009)); and Parkinson, 315 F.Supp.2d at 747-48 (stating that ‘“the manufacturer’s negligence[] is the only recognized basis of liability ” for failure to warn in connection with a medical device (quoting Hahn, 673 A.2d at 891; additional citations omitted)). ' Accordingly, we conclude that Count VII is grounded exclusively on federal duties to disclose and exists “solely by virtue of FDCA requirements.” Buckman, 531 U.S. at 353, 121 S.Ct. 1012. We therefore dismiss the fraudulent concealment claim as impliedly preempted under Buckman. Moreover, because the claim is impliedly preempted and Plaintiffs have identified no state law duty to disclose that could give rise to a claim for fraudulent concealment under Pennsylvania law, we deny Plaintiffs leave to amend this claim as we conclude that amendment would be futile. • ■ F. Counts VIII and IX — Fraudulent and Negligent Misrepresentation Count VIII of the Complaint asserts that Bayer is liable for fraudulent misrepresentation based on the misrepresentations-contained in the warranties that are the subject of the express warranty claim in Count V. Meanwhile, Count IX asserts that Bayer is liable for negligent misrepresentation based on those same misrepresentations. As we discussed in Section III. D., the alleged misrepresentations appeared on Bayer’s website, in advertisements, in brochures, and in the Essure booklet. They concern matters such as (1) whether Essure is painless, and/or “worry free,” (2) the qualifications of physicians implanting Essure, (3) whether it is possible to secure visual confirmation of Es-sure’s proper placement, and (4)' Essure’s composition (e.g., whether it is made from Silicon-free materials used in heart stents). (See Compl. ¶¶ 103-04, 107, 110-111, 113, 115.) Bayer argues that Plaintiffs’ misrepresentation claims should be dismissed as expressly preempted because Plaintiffs seek different or additional warnings regarding the safety of Essure from those required by the FDA. It argues, in the alternative, that we should dismiss the claims for failure to satisfy the pleading standards in Rule 12(b)(6) or Rule 9(b). 1. Express Preemption As noted above, pursuant to Riegel’s express preemption analysis, we must consider whether Plaintiffs’ misrepresentation claims seék to impose state requirements that are “different from, or in addition to” federal requirements applicable to Essure. Riegel, 552 U.S. at 330, 128 S.Ct. 999 (quoting 21 U.S.C. § 360k(a)(í)). Where Plaintiffs’ claims seek to enforce state requirements that parallel federal requirements,' however, there is no express preemption. Id. Plaintiffs’ misrepresentation claims are based on Pennsylvania law that imposes liability for “ ‘a misrepresentation of a material fact.. .made:. .with an intent to induce another to act on it..,[,] which results in injury to a party acting in justifiable reliance on the misrepresentation.’” Bilt-Rite Contractors, Inc. v. The Architectural Studio, 581 Pa. 454, 866 A.2d 270, 277 (2005) (quoting Bortz v. Noon, 556 Pa. 489, 729 A.2d 555, 561 (1999); and Gibbs, 647 A.2d at 889 (citations omitted)).Moreover, Pennsylvania law recognizes a cause of action based on a medical manufacturer’s misrepresentations that, in effect, ov-erpromote the manufacturer’s product and “nullify otherwise adequate warnings.” Baldino v. Castagna, M.D., 505 Pa. 239, 478 A.2d 807, 810 (1984) (citing Incollingo v. Ewing, 444. Pa. 263, 282 A.2d 206 (1971)); Wolfe v. McNeil-PPC, Inc., 773 F.Supp.2d 561, 570-71 (E.D.Pa.2011) (stating that “[a] plaintiff can bring a claim that the manner in which- a drug is promoted negated otherwise-adequate warnings” (citing Baldino, 478 A.2d at 810)). In this case, one of the conditions imposed by the PMA is that the sale and distribution of Essure -may not violate 21 U.S.C. § 352(q), which prohibits the use of false or misleading advertising. (See PMA Ltr. at 1.) Moreover, federal regulations prohibit a device from being labeled, advertised, or distributed in a manner inconsistent with any condition of approval in the PMA. See-21 C.F.R. 814.80 (prohibiting a device from being labeled, advertised,. or distributed in a manner inconsistent with any condition of approval in the PMA). Under these circumstances, we conclude that Plaintiffs can potentially allege cognizable and parallel misrepresentation claims at least insofar as they 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. See Riegel, 552 U.S. at 330, 128 S.Ct. 999 (stating that state law claims that- parallel federal requirements are not expressly preempted). Such claims would not' appear to impose standards that are “different from, or in addition to” PMA requirements but, rather, would appear to be consistent with PMA requirements. Id. (quoting 21 U.S.C. § 360k(a)(l)). We therefore deny Bayer’s Motion insofar as it argues that we should dismiss the misrepresentation claims on express preemption grounds, because all misrepresentation claims are necessarily expressly preempted. However, we reach no conclusion as to whether claims based on certain misrepresentations may be expressly preempted should the alleged misrepresentations prove to be consistent with FDA-approved statements. 2. Plausibility and Rule 9(b) Bayer argues that the misrepresentation claims in Counts VIII and IX should be dismissed because they fail to state claims upon which relief may be granted pursuant to the pleading standards in Federal Rules of Civil Procedure 12(b)(6) and 9(b). Bayer contends that we should analyze both the fraudulent and negligent misrepresentation claims pursuant to the heightened pleading standard for ■ fraud claims in Rule 9(b). As noted above, in order to state, a claim upon which relief may be granted pursuant to Rule 12(b)(6), 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.’ ” Warren Gen. Hosp., 643 F.3d at 84 (quoting Fowler, 578 F.3d at 210). Rule 9(b) imposes a more strict pleading standard by requiring that the plaintiff “state with particularity the circumstances constituting fraud or mistake.” Fed. R. Civ. P. 9(b) (emphasis added). In order to satisfy Rule 9(b), a complaint “must state the circumstances of the alleged fraud with sufficient particularity to place the defendant on notice of the ‘precise conduct with which [it is] charged.’ ” Frederico v. Home Depot, 507 F.3d 188, 200 (3d Cir.2007) (alteration in original) (quoting Lum v. Bank of Am., 361 F.3d 217, 223-24 (3d Cir.2004)), abrogated on other grounds by Twombly, 550 U.S. 544, 127 S.Ct. 1955. A plaintiff can meet this requirement “by pleading the ‘date, place or time’ of the fraud, or through ‘alternative means of injecting precision and some measure of substantiation into [his] allegations of fraud.’” Lum, 361 F.3d at 224 (quoting Seville Indus. Mach. Corp. v. Southmost Mach. Corp., 742 F.2d 786, 791 (3d Cir.1984)). “There is currently a disagreement among district courts in the Third Circuit regarding whether Rule 9(b) applies to claims based on negligent misrepresentation.” Schmidt v. Ford Motor Co., 972 F.Supp.2d 712, 720 n. 3 (E.D.Pa.2013) (comparing Hanover Ins. Co. v. Ryan, 619 F.Supp.2d 127, 142 (E.D.Pa.2007), with Brandow Chrysler Jeep Co. v. DataScan Techs., 511 F.Supp.2d 629, 537 (E.D.Pa. 2007)). Some courts have held that the “particularity requirement of Rule 9(b) applies to claims of negligent misrepresentation.” Hanover Ins. Co., 619 F.Supp.2d at 142. Other courts have stated that “Rule 9(b) does not govern claims of negligent misrepresentation.” Brandow Chrysler, 511 F.Supp.2d at 537. Still “[o]ther courts, although declining to apply Rule 9(b), have held that a plaintiff must nonetheless plead negligent misrepresentation with a degree of specificity.” Scott v. Bimbo Bakeries, USA, Inc., Civ. A. No. 10-3154, 2012 WL 645905, at *5 (E.D.Pa. Feb. 29, 2012) (citations and internal quotation marks omitted). Given this lack of consensus, we will not apply the pleading standards in Rule 9(b) to the negligent misrepresentation claim but, instead, only hold Plaintiffs’ negligent misrepresentation claim to the pleadings standard of Rule 12(b)(6) as we have done with negligent misrepresentation cla