Full opinion text
OPINION AND ORDER PAPAK, United States Magistrate Judge: Plaintiff Richard D. Alton filed this action against defendants Medtronic, Inc., and Medtronic Sofamor Danek USA, Inc. (collectively, “Medtronic”) on March 11, 2013, alleging claims of fraudulent misrepresentation and fraud in the inducement, strict products liability for failure to warn, strict products liability for defective design, strict products liability for misrepresentation, products liability for negligence, and breach of express warranty. Each of Alton’s claims arises out of complications he suffered following spine surgery in which a medical device designed, produced, and marketed by Medtronic was implanted in his cervical spine. This court has jurisdiction over Alton’s claims pursuant to 28 U.S.C. § 1332, based on the complete diversity of the parties’ citizenship and the amount in controversy.. Now before the court are Medtronic’s motion (# 19) to dismiss Alton’s claims, Medtronic’s motion (# 23) for judicial notice, and Alton’s motion (# 26) for judicial notice. I have considered the motions, oral argument on behalf of the parties, and all of the pleadings and papers on file. For the reasons set forth below, Medtronic’s motion (# 23) and Alton’s motion (# 26) for judicial notice are each granted as discussed below, and Medtronic’s motion (# 19) to dismiss is granted in part and denied in part as discussed below. LEGAL STANDARDS I. Request for Judicial Notice Federal Rule of Evidence 201(d) provides that “[a] court shall take judicial notice [of an adjudicative fact] if requested by a party and supplied with the necessary information.” An adjudicative fact is subject to judicial notice when the fact is “not subject to reasonable dispute in that it is either (1) generally known within the territorial jurisdiction of the trial court or (2) capable of accurate and ready determination by resort to sources whose’accuracy cannot reasonably be questioned.” Fed. R.Evid. 201(b). II. Motion to Dismiss To survive dismissal for failure to state a claim pursuant to Rule 12(b)(6), a complaint must contain more than a “formulaic recitation of the elements of a cause of action;” specifically, it must contain factual allegations sufficient to “raise a right to relief above the speculative level.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). To. raise a right to relief above the speculative level, “[t]he pleading must contain something more ... than ... a statement of facts that merely creates a suspicion [of] a legally cognizable right of action.” Id., quoting 5 C. Wright & A. Miller, Federal Practice and Procedure § 1216, pp. 235-236 (3d ed.2004); see also Fed.R.Civ.P. 8(a). Instead, the plaintiff must plead affirmative factual content, as opposed to any merely conclusory recitation that the elements of a claim have been satisfied, that “allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009). “In sum, for a complaint to survive a motion to dismiss, the non-conclusory ‘factual content,’ and reasonable inferences from that content, must be plausibly suggestive of a claim entitling the plaintiff to relief.” Moss v. United States Secret Serv., 572 F.3d 962, 970 (9th Cir.2009), citing Iqbal, 129 S.Ct. at 1949. “In ruling on a 12(b)(6) motion, a court may generally consider only allegations contained in the pleadings, exhibits attached to the complaint, and matters properly subject to judicial notice.” Swartz v. KPMG LLP, 476 F.3d 756, 763 (9th Cir.2007). In considering a motion to dismiss, this court accepts all of the allegations in the complaint as true and construes them in the light most favorable to the plaintiff. See Kahle v. Gonzales, 474 F.3d 665, 667 (9th Cir.2007). Moreover, the court “presume[s] that general allegations embrace those specific facts that are necessary to support the claim.” Nat’l Org. for Women v. Scheidler, 510 U.S. 249, 256, 114 S.Ct. 798, 127 L.Ed.2d 99 (1994), quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 561, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). The court need not, however, accept legal conclusions “cast in the form of factual allegations.” Western Mining Council v. Watt, 643 F.2d 618, 624 (9th Cir.1981). FACTUAL BACKGROUND Alton’s complaint in this matter is voluminous, as are the materials submitted to the court as fit matters for judicial notice. In consequence, I provide here only a brief summary of the material allegations and facts. On July 2, 2002, Medtronic received premarket approval (“PMA”) from the federal Food and Drug Administration (the “FDA”) for its Infuse device (a “Class III” medical device under the classification framework of the Medical Device Amendments of 1976). The Infuse device approved by the FDA consists of a recombinant bone morphogenetic protein referred to as rhBMP-2 used in connection with a collagen scaffold (sponge) and a tapered metallic spinal fusion cage (interbody cage). The Infuse device was specifically approved as of July 2, 2002, for use in surgery on the lumbar spine performed through the abdomen (an anterior approach; this procedure is referred to as anterior lumbar interbody fusion surgery, or “ALIF”). Certain alternate interbody cage designs were approved by the FDA on December 1, 2003. The FDA subsequently approved the Infuse device for use in repairing certain tibia fractures and certain oromaxillary surgeries, and-approved the Infuse rhBMP-2 protein component for use in the absence of the sponge or any interbody cage in certain sinus augmentations and alveolar ridge augmentations. At or around the time it obtained initial FDA approval for the Infuse device, Medtronic began expending large sums of money in efforts to promote so-called “off-label” uses of the device, namely, any application other than those specifically approved by the FDA. These off-label applications included the use of the rhBMP protein without the specific interbody cage approved by the FDA as part of the Infuse device in connection with lumbar spine surgeries with a transforaminal or posteri- or approach (referred to as posterior lumbar interbody fusion or “PLIF” surgery). Even before it obtained FDA approval for any application of the Infuse device, Medtronic was aware of studies demonstrating that applications of the device other than those ultimately approved by the FDA were associated with significant adverse consequences, sometimes resulting in conditions of the spine that were worse than the condition necessitating surgical intervention in the first instance, in some cases life-threatening conditions. Specifically, off-label applications of the device such as PLIF surgery resulted, in a high percentage of applications, in “exuberant bone growth” (sometimes referred to as “ectopic bone growth”) in the location where the bone protein component of the device was applied. Medtronic did not report these adverse results to the FDA, and to the contrary suppressed information regarding adverse consequences in the course of its efforts to promote off-label applications such as PLIF. As a result of Medtronic’s efforts to promote off-label applications of the device and applications of components of the device and of Medtronic’s efforts to suppress reports of adverse consequences from such applications, by 2010 the Infuse device and its protein component were more frequently used off label than for approved applications, and became a huge source of profit for Medtronic. On April 7, 2010, Alton underwent PLIF surgery in which the protein component of the Infuse device was implanted in his lumbar spine without the appropriate interbody cage. At the time he conducted the surgery, Alton’s surgeon was unaware of known risks associated with such application of the protein component of the device, due to Medtronic’s suppression of information regarding such risks. Alton subsequently developed uncontrolled exuberant bone growth in his lumbar spine, necessitating further surgery and resulting in significant pain symptoms. ANALYSIS 1. Parties’ Requests for Judicial Notice By and through its motion (#23) for judicial notice, Medtronic requests that the eourt take notice of documents constituting: (i) the FDA PMA database listing for the Infuse device indicating a July 2, 2002, decision date approving the device for spinal fusion procedures in skeletally mature patients with degenerative disc disease at one level from L4-S1; (ii) the FDA’s PMA letter for the Infuse device dated July 2, 2002, approving the device for spinal fusion procedures in skeletally mature patients with degenerative disc disease at one level from L4-S1; (iii) a supplemental FDA PMA database listing for the Infuse device indicating a March 27, 2013, supplemental decision date approving a modification to the process for using the device, specifically the addition of an alternate water supplier; (iv) a supplemental FDA PMA database listing for the Infuse device indicating a December 1, 2003, supplemental decision date approving a modification to the device, specifically the addition of alternate interbody cage designs; (v) the FDA’s PMA letter for the rhBMP-2 protein dated April 30, 2004, approving the protein for the treatment of acute, open tibial shaft fractures stabilized with intramedullary nail fixation in skeletally mature patients; (vi) the FDA’s PMA letter for the rhBMP2 protein dated March 9, 2007, approving the protein for sinus augmentations and for localized alveolar ridge augmentations for defects associated with extraction sockets; (vii) an FDA “Important Medical Information” advisory regarding the Infuse device and the rhBMP-2 component thereof; and (viii) the FDA’s “Summary of Safety and Effectiveness Data” for the Infuse device. By and through his motion (# 26) for judicial' notice, Alton requests that the court take notice of documents constituting: (i) an FDA “Important Medical Information” advisory regarding the Infuse device and the rhBMP-2 component thereof (identical to the seventh-enumerated document of which Medtronic requests judicial notice); (ii) a “Staff Report on Medtronic’s Influence on Infuse Clinical Studies” prepared by the staff of the United States Senate Finance Committee and dated October 2012; (in) an August 20, 2012, “Notice of Ruling” issued by the Los Angeles County Superior Court of the State of California denying Medtronic’s motion for summary judgment in Case No. BC465313, a products liability action arising out- of an application of the Infuse device; (iv) a June 22, 2012, Judgment of Dismissal issued by the Los Angeles County Superior Court of the State of California dismissing product liability claims against Medtronic in Case No. SC 112290; (v) a February 21, 2013, court order issued by a trial court of the State of Colorado in Case No. 12CV40 denying Medtronic’s motion to dismiss claims brought against it in connection with an off-label use of the rhBMP-2 protein for spinal surgery without an interbody cage; (vi) a March 5, 2013, court order issued by the MiamiDade County Circuit Court of the State of Florida denying Medtronic’s motion to dismiss in an action against it; (vn) an October 2, 2008 release by the United States Senate Finance Committee of a September 20, 2008, letter from Senator Grassley to Medtronic regarding its financial relationships with private physicians; (viii) a June 22, 2011, release by the United States Senate Finance Committee of a June 21, 2011, letter from Senators Baueus and Grassley to Medtronic regarding evidence and press reports that “doctors conducting clinical trials examining the safety and effectiveness of Infuse ... were aware that Infuse ... may cause medical complications, but failed to report this in the medical literature,” an “issue ... compounded by the fact that some clinical investigators have substantial financial ties to Medtronic;” (ix) a December 13, 2011, letter from Senators Blumenthal, Grassley, and Kohl to Medtronic requesting information as to how Medtronic “handles recalls and post-marketing surveillance of [its] products;” and (x) a January 17, 2012 judgment of the United States District Court for the District of Massachusetts in criminal Case No. 09-10330-GAO reflecting the guilty plea of defendant Stryker Biotech, LLC, to distributing a misbranded device. Neither party requests with particularity that the court take notice of any specific adjudicative fact set forth within any of the identified documents, but rather each party appears to request that the court take notice of the contents of all of the identified documents generally. It is clear that each identified document contains adjudicative facts capable of ready determination, but equally clear that at least some of the identified documents contain content that does not constitute such an adjudicative fact. Nevertheless, because each identified document sets forth at least some fit matters for judicial notice, the parties’ motions are granted, and I take judicial notice of adjudicative facts contained within the identified documents. Other content of the identified documents has been and will be disregarded. II. Medtronic’s Motion to Dismiss By and through its motion to dismiss, Medtronic chiefly argues that each of Alton’s claims is preempted under the federal Food, Drug, and Cosmetic Act of 1938 (the “FDCA”), and in the alternative argues that Alton’s design defect claim is barred under Restatement of Torts Section 402A, Comment k, that his breach of express warranty claim necessarily fails because Medtronic has disclaimed all express warranties, and that his fraud claim necessarily fails because it is not pled with adequate particularity. I address each set of arguments in turn below. A. Preemption Under the FDCA 1. The FDCA Preemption Framework By and through the Food and Drug Act of 1906 (the “1906 Act”), Congress prohibited the manufacture or shipment through interstate commerce of any adulterated or misbranded food or drug. In 1938, through passage of the FDCA, Congress broadened the coverage of the 1906 Act to include within its scope adulterated or misbranded medical devices and cosmetics. As originally enacted, however, the FDCA did not provide any mechanism for governmental oversight of the process of introducing new medical devices. In 1976, by and through the Medical Device Amendments of 1976 (the “MDA”), Congress enacted significant amendments to the FDCA. Under the FDCA as modified by the MDA, medical devices are classified into three categories based on the potential risk they pose. Devices posing the greatest risk are classified as “Class III” devices. See 21 U.S.C. § 360c(a)(l)(G). Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a “reasonable assurance” that the device is both safe and effective. See 21 U.S.C. § 360e(d)(2). Despite its relatively innocuous phrasing, the process of establishing this “reasonable assurance,” which is known as the “premarket approval,” or “PMA” process, is a rigorous one. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). Indeed, the Supreme Court has characterized the premarket approval (“PMA”) process as constituting the Congressionally mandated “federal safety review” process. Riegel v. Medtronic, Inc., 552 U.S. 312, 323, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008) (“Premarket approval ... is in no sense an exemption from federal safety review-it is federal safety review” (emphasis original)). A manufacturer’s obligations under the FDCA do not end with premarket approval. Even after premarket approval issues, manufacturers are required to report to the FDA “no later than 30 calendar days after the day” the manufacturer “received or otherwise become[s] aware of information, from any source, that reasonably suggests that a device” marketed by the manufacturer: (1) May have caused or contributed to a death or serious injury; or (2) Has malfunctioned and this device or a similar device [likewise marketed by the manufacturer] would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. 21 C.F.R. § 803.50(a); see also 21 U.S.C. § 360i(a) (further detailing the post-approval reporting requirements applicable to device manufacturers); Riegel, 552 U.S. at 319, 128 S.Ct. 999; Stengel v. Medtronic Inc., 704 F.3d 1224, 1226-1227 (9th Cir. 2013) (en banc). In addition, manufacturers are required to make periodic reports to the FDA regarding approved devices, such reports to include summaries of: (i) Unpublished reports of data from any clinical investigations or nonclinical laboratory studies involving the device or related devices and known to or that reasonably should be known to the applicant. (ii) Reports in the scientific literature concerning the device and known to or that reasonably should be known to the applicant. 21 C.F.R. § 814.84(b)(2). The FDCA does not prohibit nor purport to regulate the use by physicians of medical devices for applications that have not been approved by the FDA (so-called “off-label” applications). Indeed, the off-label application of medical devices is not discouraged by the FDA, and is generally accepted to be both necessary and valuable. See, e.g., Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). However, the FDCA as amended by the MDA expressly prohibits manufacturers from the “introduction or delivery for introduction into interstate commerce of any ... device ... that is ... misbranded.” 21 U.S.C. § 331(a). A device is misbranded under the FDCA as amended if, inter alia, “its labeling is false or misleading in any particular,” 21 U.S.C. § 352(a), or its labeling does not bear “adequate directions for use,” 21 U.S.C. § 352(f)(1). Adequate directions for the use of a medical device “means directions under which the layman can use [the] device safely and for the purposes for which it is intended.” 21 C.F.R. § 801.5. “Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specification of ... [statements of all conditions, purposes, or uses for which such device is intended.” 21 C.F.R. § 801.5(a). For purposes of the FDCA, the intended use of a medical device is determined on the basis of “the objective intent of the persons legally responsible for the labeling of [such] device[].” 21 C.F.R. § 801.4. [Such] intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article .for different uses than those intended by the person from whom he received the devices, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put. Id. Criminal penalties obtain where manufacturers are found to have violated the FDCA prohibition against misbranding, see 21 U.S.C. § 333(a), as do civil penalties in the form of fines payable to the United States, see 21 U.S.C. § 333(f). However, there is no private right of action under the FDCA for a manufacturer’s violation of its provisions, including the prohibition against the sale or distribution of misbranded devices. See 21 U.S.C. § 337(a); see also, e.g., Buckman, 531 U.S. at 349, n. 4, 121 S.Ct. 1012. The FDCA as modified by the MDA contains an express preemption provision as follows: 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) The FDCA implementing regulations consistently provide, inter alia, that: State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the [FDCA], thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements. ■21 C.F.R. § 808.1(d). A trilogy of United States Supreme Court cases provide guidance for analysis of preemption under Section 360k(a). The first of these was Medtronic, Inc. v. Lohr, supra, decided in 1996. The medical device at issue in Lohr was a pacemaker (a Class III device) that had not been approved by the FDA through the rigorous PMA process, but rather had avoided, the premarket approval requirement by being designated as “substantially equivalent” to a preexisting device already on the market through the less rigorous “Section 510(k) process.” The Eleventh Circuit had ruled that the Lohr plaintiffs’ claims of strict products liability for design defect and for negligence in design were not preempted, but that the plaintiffs’ claims of negligent manufacture and negligent failure to warn were preempted. Medtronic appealed the Eleventh Circuit’s decision that the claims sounding in negligence were not preempted, and the plaintiffs appealed the decision to the extent it upheld Medtronic’s preemption defense. Although all nine Lohr justices either expressly or implicitly rejected Medtronic’s argument that, where the FDA imposes requirements on a medical device, all common-law causes of action arising out of an application of the device are necessarily preempted pursuant to Section 360k(a), see Lohr, 518 U.S. at 486-491, 505-508, 116 S.Ct. 2240 (Breyer, J., concurring in part and concurring in the judgment), 512-513 (O’Connor, J., concurring in part and dissenting in part, joined by Rehnquist, Ch. J., Sealia, J., and Thomas, J.), only a plurality of four justices adopted Part IV of Justice Stevens’ opinion, in which that argument was specifically analyzed, see id. at 486-491, 116 S.Ct. 2240. Part IV expressed the plurality’s opinion that “Medtronic’s argument [wa]s not only unpersuasive [but also] implausible,” in that any broad construction of FDCA/MDA preemption would have “the perverse effect” of largely immunizing medical device manufacturers from liability to private citizens harmed by their products, notwithstanding the express judgment of Congress that the medical device industry was in need of “more stringent regulation in order ‘to provide for the safety and effectiveness of medical devices intended for human use.’ ” Id. at 487, 116 S.Ct. 2240, quoting 90 Stat. 539. The plurality further opined in Part TV that Section 360k “simply was not intended to pre-empt most, let alone all, general common-law duties enforced by damages actions,” and concluded that notwithstanding enactment of the MDA “at least some common-law claims may be maintained” against medical device manufacturers. Id. at 491, 116 S.Ct. 2240. Justice Stevens and three other justices’ supported the plurality’s opinion in Part IV in part on a reading of Congressional intent pursuant to which the statutory term “requirements” would be given a narrower construction in connection with state-law causes of action than the court had previously ascribed to the same term in the context of the preemption provision of the Public Health Cigarette Smoking Act of 1969. See id. at 487-491, 116 S.Ct. 2240. As noted above, all nine justices agreed that some or all of the Lohr plaintiffs’ common-law claims against Medtronic survived FDCA/MDA preemption, and thus agreed with the ultimate conclusion reached by the plurality in Part IV. Nevertheless, Justice Breyer expressly stated that he did not join in Part IV of the court’s opinion “which emphasize[d] the differences between the MDA [preemption provision] and the preemption [provision of the Public Health Cigarette Smoking Act of 1969], because those differences [we]re not ... relevant,” id. at 508, 116 S.Ct. 2240 (Breyer, J., concurring in part and concurring ,in the judgment), and three justices joined in Justice O’Connor’s partial dissent which likewise disagreed with the plurality that the statutory term “requirements” should be read more narrowly for FDCA/ MDA preemption purposes than for purposes of Public Health Cigarette Smoking Act of 1969 preemption purposes. See id. at 510-512, 116 S.Ct. 2240 (O’Connor, J., concurring in part and dissenting in part). All nine Lohr justices agreed that the FDA does not impose “requirements” specifically regarding the design of a medical device when the device is approved through the Section 510(k) process, with the consequence that the Section 360k(a) preemption provision is entirely inapplicable to state-law design defect claims arising in connection with a device approved under Section 510(k). See id. at 492-494, 508, 116 S.Ct. 2240 (Breyer, J., concurring in part and concurring in the judgment), 513 (O’Connor, J., concurring in part and dissenting in part). In consequence, the court affirmed the Eleventh Circuit’s decision that the design defect claims were not preempted. See id. More critically for present purposes, all nine justices further held that, on the arguendo assumptions that the FDA had placed cognizable requirements on the pacemaker through Section 510(k) approval and that recognition of state common-law claims arising out of applications of the device would constitute imposition of state requirements for preemption purposes, there could be no FDCA/MDA preemption of state claims arising out of the violation of state-law duties that “parallel” duties arising under the FDCA: Nothing in § 360k denies [the states] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements. Even if it may be necessary as a matter of [state] law to prove that those violations were the result of negligent conduct, or that they created an unreasonable hazard for users of the product, such additional elements of the state-law cause of action would make the state requirements narrower, not broader, than the federal requirement. While such a narrower requirement might be “different from” the federal rules in a literal sense, such a difference would surely provide a strange reason for finding preemption of a state rule insofar as it duplicates the federal rule. The presence of a damages remedy does not amount to the additional or different “requirement” that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing “requirements” under federal law. Id. at 495, 116 S.Ct. 2240 (emphasis supplied); see also id. at 508, 116 S.Ct. 2240 (Breyer, J., concurring in part and concurring in the judgment; concurring in the quoted holding), 513 (O’Connor, J., concurring in part and dissenting in part; agreeing with the quoted holding). On this basis, the court held that the plaintiffs’ negligent manufacture and negligent -failure to warn claims were clearly not preempted to the extent premised on state-law duties “equal to, or substantially identical to, requirements imposed” under the FDCA. Id. at 496-497, 116 S.Ct. 2240. All nine justices concurred in this holding. See id. at 508, 116 S.Ct. 2240 (Breyer, J., concurring in part and concurring in the judgment; concurring in the cited holding), 513-514, 116 S.Ct. 2240 (O’Connor, J., concurring in part and dissenting in part; concurring in the cited holding). Turning to the question whether the negligent manufacture or negligent failure to warn claims constituted parallel claims that would escape preemption to the extent those claims were premised on the violation of state-law duties of general applicability that were not substantially identical to FDCA requirements, a five justice majority opined that unless both (i) the state-law duties in question were promulgated “with respect to” a medical device or devices and (ii) the requirements imposed pursuant to such state-law -duties interfere with specific requirements promulgated by the FDA with respect to the medical device or devices, there would be no FDCA/ MDA preemption: Although we do not believe that th[e] statutory and regulatory language [codified at 21 C.F.R. §§ 801(d) and 808.53-101] necessarily precludes “general” federal requirements from ever pre-empting state requirements, or “general” state requirements from ever being preempted ..., it is impossible to ignore its overarching concern that pre-emption occur only where a particular state requirement threatens to interfere with a specific federal interest. State requirements must be “with respect to” medical devices and “different from, or in addition to,” federal requirements. State requirements must also relate “to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device,” and the regulations provide that state requirements of “general applicability” are not preempted except where they have “the effect of establishing a substantive requirement for a specific device.” Moreover, federal requirements must be “applicable to the device” in question, arid, according to the regulations, preempt state law only if they are “specific counter-part regulations” or “specific” to a “particular device.” The statute and regulations, therefore, require a careful comparison between the allegedly preempting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations. Id. at 500, 116 S.Ct. 2240 (emphasis supplied); see also id. at 508, 116 S.Ct. 2240 (Breyer, J., concurring in part and concurring .in the judgment; concurring in the quoted language). Because the plaintiffs’ claims (to the extent not premised on state-law duties substantially equivalent to FDA-promulgated duties) were premised on state-law duties of general applicability rather than on requirements imposed under state law with respect to specific medical devices, the Lohr majority held that the claims (so construed) were not preempted: [The mandated claim-by-claim] comparison [between purportedly preempting federal requirement(s) and potentially preempted state requirement(s) ] mandates a conclusion that the [plaintiffs]’ common-law claims are not pre-empted by the federal labeling and manufacturing requirements. The generality of those requirements make this quite unlike a case in which the Federal Government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers. Rather, the federal requirements reflect important but entirely generic concerns about device regulation generally, not the sort of concerns regarding a specific device or field of device regulation that the statute or regulations were designed to protect from potentially contradictory state requirements. Similarly, the general state common-law requirements in this suit were not specifically developed “with respect to” medical devices. Accordingly, they are not the kinds of requirements that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements. The legal duty that is the predicate. for- the Lohrs’ negligent manufacturing claim is the general duty of every manufacturer to use due care to avoid foreseeable dangers in its products. Similarly, the predicate for the failure to warn claim is the general duty to inform users, and purchasers of potentially dangerous items of the risks involved in their use. These general obligations are no more a threat to federal requirements than would be a state-law duty to comply with local fire prevention regulations and zoning codes, or to use due care in the training and supervision of a work force. These state requirements therefore escape pre-emption, not because the source of the duty is a judge-made common-law rule, but rather because their generality leaves them outside the category of requirements that § 360k envisioned to bé “with respect to” specific devices such as pacemakers. As a result, none of the [plaintiffs]’ claims based on allegedly defective manufacturing or labeling are pre-empted by the MDA. Id. at 501-502, 116 S.Ct. 2240 (emphasis 'supplied); see also id. at 508, 116 S.Ct. 2240 (Breyer, • J., concurring in part and concurring.in-the judgment; concurring in the quoted language). The second Supreme Court case in the FDCA/MDA preemption trilogy was Buckman Co. v. Plaintiffs’ Legal Comm., supra, decided in 2001. The medical device at issue in Buckman was a bone screw (a Class III device) that, like the pacemaker at issue in Lohr, had avoided the premarket approval requirement by being- designated as “substantially equivalent” to a pre-existing device already on the market through the less rigorous Section 510(k) process. Although the Buckman court expressly did not repudiate the analysis set forth in Lohr, the court found the plaintiffs cause of action for fraud on the FDA (premised on the theory that the device manufacturer had made fraudulent statements to the FDA resulting in improper approval of the device) was impliedly preempted in that the cause of action existed solely by virtue of requirements imposed pursuant to the FDCA, the provisions of which are expressly enforceable only by the FDA, and give rise to no private right of action: Given this analytical framework, ... the plaintiffs’ state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by federal law. The conflict stems from the'fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Agency, and that this authority is used by the Agency to achieve a somewhat delicate balance of statutory objectives. The balance sought by the Agency can be skewed by - allowing fraud-on-the-FDA claims under state tort law. Buckman, 531 U.S. at 348, 121 S.Ct. 1012 (footnote omitted). The Buckman court clarified that its holding was consistent with the reasoning of the Lohr court: Notwithstanding the fact that Medtronic [v. Lohr] did not squarely address the question of implied pre-emption, it is clear that the Medtronic [v. Lohr] claims arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements. See 518 U.S. at 481, 116 S.Ct. 2240. In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although Medtronic [v. Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim. Id. at 352-353,121 S.Ct. 1012. The third Supreme Court case in the trilogy was Riegel v. Medtronic, Inc., supra, decided in 2008. The medical device at issue in Riegel was a Class III balloon catheter that had received premarket approval from the FDA following the rigorous PMA process. As a preliminary matter, the Riegel court expressly found that the PMA process imposed “requirements” on an approved device for purposes of Section 360k. Riegel, 552 U.S. at 322-323, 128 S.Ct. 999. In addition, the Riegel majority clarified that it “adhered” to the view of the five justices who did not join in Part IV of the Lohr plurality’s opinion, that state common-law claims are predicated on the violation of “requirements,” and are thus preempted where those underlying requirements are “in addition to or different from” FDA-promulgated requirements. Id. at 323-324, 128 S.Ct. 999. However, the Riegel court expressly affirmed the reasoning of the Lohr court cited above that: State requirements are pre-empted under the MDA only to the extent that they are “different from, or in addition to” the requirements imposed by federal law. § 360k(a)(1). Thus, § 360k 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. Id. at 330, 128 S.Ct. 999 (emphasis supplied), citing Lohr, 518 U.S. at 495, 116 S.Ct. 2240. Because the plaintiffs’ claims were pled as asserting Medtronic’s liability for violation of state-law duties “notwithstanding compliance with the relevant federal requirements,” the Riegel court found the plaintiffs’ claims clearly preempted under the plain language of Section 360k(a). Id. The court expressly declined to consider the argument, raised for the first time on appeal, that the plaintiffs’ claims could be construed as “parallel” claims. See id. In.2010, the Seventh Circuit persuasively applied the preemption analysis set forth in the Supreme court’s FDCA/MDA preemption trilogy to a Class III hip implant approved by the FDA under the rigorous PMA process. The court prefaced its reasoning as follows: The central issue in this appeal is whether federal law preempts product liability cláims against manufacturers of Class III medical devices where a patient claims that she was harmed by the manufacturer’s violation of federal law. That statement of the issue may be a little startling. The idea that Congress would have granted civil immunity to medical device manufacturers for their violations of federal law that hurt patients is, to say the least, counter-intuitive. Nevertheless, manufacturers in this case and in others have asserted this theory of defense. As we explain below, the manufacturer’s theory tries to stretch the Supreme Court’s decisions in this field beyond the boundaries that were made clear in those decisions. Medical device manufacturers who subject their Class III devices to the rigorous premarket approval process are protected by federal law from civil liability so long as they comply with federal law. That protection does not apply where the patient can prove. that she was hurt by the manufacturer’s violation of federal law. Bausch v. Stryker Corp., 680 F.3d 546, 549-550 (7th Cir.2010) (italicized emphasis original; bolded emphasis supplied). In the course of analyzing whether state law claims premised on violation of the FDCA could be expressly preempted under Section 360k, the Bausch court set out and applied an analytic framework according to which state-law claims are not preempted if based on conduct proscribed by the FDCA but also independently actionable under state law of general applicability, as follows: Section 360k provides immunity for manufacturers of new Class III medical devices to the extent that they comply with federal law, but it does not protect them if they have violated federal law. Just as a plaintiff in an auto accident may use the other driver’s speeding violation as evidence of negligence, plaintiff Bausch; claims that she was injured by [defendant] Stryker’s violations of federal law in manufacturing the device implanted in her hip. It remains to be seen whether she can prove those allegations, including causation and damages. But if she can prove those allegations of harm caused by violations of federal law, her claims under state law would not impose on defendants any requirement “different from, or in addition to/any requirement” imposed by federal law. Her claims are • not preempted. Bausch, 630 F.3d at 553.' The Bausch court further found that, because the plaintiffs claims were independently actionable under state law, her claims were not impliedly preempted under the reasoning of the Buckman court. See id. at 558. Shortly thereafter, the. Fifth Circuit applied the Supreme Court’s FDCA/MDA jurisprudence to reach a comparable result in connection with a failure to warn claim brought under Mississippi law and predicated in parallel part on the defendant’s violation of its duty under the FDCA to report adverse outcomes, See Hughes v. Boston Scientific Corp., 631 F.3d 762, 776 (5th Cir.2011). The Hughes court specifically held that the “failure to warn claim is neither expressly nor impliedly preempted by the MDA to the extent that this claim is premised on [the defendant manufacturer]^ violation of FDA regulations with respect to reporting [adverse outcomes] caused by the device.” Id. (internal modifications omitted). The Ninth Circuit’s recent en banc decision in Stengel v. Medtronic, Inc., supra, decided in 2013, cited Bausch and Hughes with approval and largely adopted (and further developed) the analytic framework proposed in Bausch. See Stengel, 704 F.3d. at 1233- (“In holding that the Stengels’ failure-to-warn claim is not preempted, we join the Fifth and Seventh Circuits, which reached the same conclusion with respect to comparable state-law claims in Hughes and Bausch”)', see id. at 1232 (quoting Bausch with approval for the proposition that “[t]he idea that Congress would have granted civil immunity to medical device manufacturers for their violations of federal law that hurt patients is; to say the least, counter-intuitive”). The medical device at issue in Stengel was a Class III pain pump that had received FDA approval following the rigorous PMA process, a malfunction in which had seriously injured one of the plaintiffs. The factual history underlying the Stengel claims is broadly analogous to the history underlying the claims at issue here: When it received FDA approval of [the Class III pain pump device], Medtronic was not aware of certain risks associated with the device. Before [the injured plaintiff] was paralyzed, however, Medtronic had become well aware of those risks but had failed to inform the FDA, even though the MDA required Medtronic to do so. The FDA discovered the risks, and discovered that Medtronic already knew about them, when it inspected a Medtronic facility in late 2006 and early 2007. The FDA sent a Warning Letter to Medtronic in July 2007, stating that Medtronic had “misbranded” its Class III device by concealing known risks, in violation of 21 C.F.R. §§ 803.50(a)(1), 806.10(a)(1). In response to the FDA’s Warning Letter, Medtronic sent a Medical Device Correction letter to doctors in January 2008. Medtronic recalled the device in March 2008. This advice and recall came too late to help [the injured plaintiff], who had been paralyzed in 2005. Id. at 1227. The Stengel plaintiffs sought to amend their complaint to allege that Medtronic had violated its duty to the FDA to report adverse consequences of reliance on its FDA-approved device, and that its failure to comply with that duty constituted an independently actionable duty to use reasonable care under Arizona negligence law. See id. at 1232. The court found this proposed claim not preempted under either Section 360k(a) or Buckman: The [plaintiffs]’ proposed new claim under Arizona law, insofar as the state-law duty parallels a federal-law duty under the MDA, is not preempted. Arizona state law has long been concerned with the protection of consumers from harm caused by manufacturers’ unreasonable behavior. Plaintiffs’ claim is brought under settled Arizona law that protects the safety and health of Arizona citizens by imposing a general duty of reasonable care on product manufacturers. The whole modern law of negligence, with its many developments, enforces the duty of fellow-citizens to observe in varying circumstances an appropriate measure of prudence to avoid causing harm to one another.... Arizona tort law includes a cause of action for failure to warn. Under Arizona law, negligence standards impose a duty to produce products with appropriate warning instructions.... A product may be unreasonably dangerous in the absence of adequate warnings. ... The manufacturer of a product must warn of dangers which he knows or should know are inherent in its use. This duty may be a continuing one applying to dangers the manufacturer discovers after sale____ If a more precise parallel were necessary, the Stengels have alleged it and Arizona law provides it. The Stengels’ new claim specifically alleges, as a violation of Arizona law, a failure to warn the FDA. Arizona law contemplates a warning to a third party such as the FDA. Under Arizona law, a warning to a third party satisfies a manufacturer’s duty if, given the nature of the warning and the relationship of the third party, there is reasonable assurance that the information will reach those whose safety depends on their having it.... We do not decide whether plaintiffs can prevail on their state-law failure-to-warn claim. That question is not before us. But we do hold, under Lohr, Buckman, and Riegel, that this claim is not preempted, either expressly or impliedly, by the NMA. It is a state-law claim that is independent of the FDA’s pre-market approval process that was at issue in Buckman. The claim rests on a state-law duty that parallels a federal-law duty under the NMA, as in Lohr. In holding that the Stengels’ failure-to-warn claim is not preempted, we join the Fifth and Seventh Circuits, which reached the same conclusion with respect to comparable state-law claims in Hughes and Bausch. Id. at 1233 (citations, internal quotation marks omitted; emphasis supplied). Moreover, in interpreting the Supreme Court’s “parallel claim” jurisprudence, the Stengel court emphasized the continuing importance of the Lohr court’s holding that FDCA/MDA preemption occurs only where a state-law duty is promulgated “with respect to” a medical device: The [Lohr] Court held that the MDA did not preempt the [Lohr plaintiffs]’ state-law claim alleging that Medtronic negligently had failed to warn “plaintiff or her physicians” of the known dangers of its pacemaker. The generality of the state-law duty to warn was important to the Court’s analysis. The Court wrote: The predicate for the failure to warn claim is the general duty to inform users and purchasers of potentially dangerous items of the risks involved in their use. This general obligation is no more a threat to federal requirements than would be a state-law duty to' comply with local fire prevention regulations and zoning codes, or to use due care in the training and supervision of a work force. ■ ■ [Lohr, 518 U.S.] at 501-02 [116 S.Ct. 2240]. The state-law duties upon which the [Lohr plaintiffs] relied escape preemption “because their generality leaves them outside the category of requirements that § 360k envisioned to be ‘with respect to’ specific devices such as pacemakers.” Id. at 502 [116 S.Ct. 2240]. Id. at 1229 (emphasis supplied; internal modifications omitted), quoting Lohr, 518 U.S. at 501-502, 502, 116 S.Ct. 2240. Still more recently than Stengel, the Ninth Circuit again addressed the question of FDCA/MDA preemption in Perez v. Nidek Co., 711 F.3d 1109, 1111 (9th Cir.2013), a panel decision. The Perez plaintiffs did not claim to have been injured in any manner, but claimed that the defendants’ off-label use of a Class III laser to surgically correct hyperopia was in violation of the California Protection of Human Subjects in Medical Experimentation Act (the “Human Subjects Act”) and the California Consumers Legal Remedies Act (the “Consumers Act”). In addition, the plaintiffs brought a claim of “fraud by omission” on the theory that the defendants had failed to advise the plaintiffs that the hyperopic surgeries were an off-label application of the laser. The appeals court found that the plaintiffs had no claim under the Human Subjects Act because the surgeries were not cognizable as medical experiments, and that the plaintiffs lacked standing under the circumstances to sue under the Consumers Act. As to the claim of fraud by omission, the court found the claim both expressly preempted under Section 360k(a) and impliedly preempted under the reasoning of Buckman. The court affirmed its recent en banc holding in Stengel that the Supreme Court’s MDA preemption trilogy collectively stand for the proposition that “the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.” Perez, 711 F.3d at 1117, quoting Stengel, 704 F.3d at 1228. However, the Perez court distinguished the fraud claim at issue before it from the negligent failure to warn claim at issue in Stengel on the basis that the fraud claim, if permitted, would effectively place a greater disclosure requirement on the defendants than was imposed under the FDCA, namely, the requirement that manufacturers and others expressly disclose that the device was not approved for off-label applications. See id. at 1118. In consequence, the court found the claim expressly preempted. See id. The Perez court further found the claim impliedly preempted under Buck-man, on the grounds that the claim was premised entirely and exclusively on the existence of FDA requirements regarding the approved uses of the device. See id. at 1119. The court concluded that: Although [the plaintiffs are] not barred from bringing any fraud claim related to the surgeries, [they] cannot bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of PMA approval. While courts have acknowledged that some fraud and false advertising claims related to FDA status may go forward, [the plaintiffs] eite[ ] to no case where a court has allowed a plaintiff to bring suit solely for failure to disclose lack of FDA approval. Id. at 1119-1120. Although Lohr, Buckman, Riegel, Stengel, and Perez constitute the universe of FDCA/MDA-preemption case law precedent binding on this court, a number of other courts have also weighed in on the legal issues involved in applying the governing jurisprudence. The decisions vary widely in their constructions and applications. Exemplifying the approach of construing the preemptive effect of FDA premarket approval broadly is Caplinger v. Medtronic, Inc., 921 F.Supp.2d 1206 (W.D.Ok.2013), a recent decision of the district court for the western District of Oklahoma, in which the court found — with one exception — claims similar to those asserted by Alton in this action and likewise arising out of complications following use of the Infuse device either preempted under Section 360k(a) and Riegel, impliedly preempted under Buckman, or both. Before the Caplinger court were claims of fraudulent misrepresentation and fraud in the inducement, constructive fraud, strict products liability for failure to warn, strict products liability for defective design, breach of express warranty, breach of implied warranty, negligence, and negligent misrepresentation. The court analyzed the preemptive effect of the FDA’s PMA approval of the Infuse device as to each claim in turn. As to the plaintiffs fraudulent misrepresentation and fraud in the inducement claim, the court reasoned that the claim could have three possible factual underpinnings: (i) alleged misrepresentations and/or omissions in the FDA-mandated warnings and labels accompanying the Infuse device, (ii) alleged misrepresentations and/or omissions in Medtronic’s reports to the FDA with regard to Medtronic’s practice of marketing off-label applications of the Infuse device to physicians, or (in) alleged misrepresentations and/or omissions made by Medtronic in the course of marketing off-label applications of the Infuse device to physicians. See- Caplinger, 921 F.Supp.2d at 1218-20. The court found that to the extent the claim was construed as premised on alleged misrepresentations and/or omissions in the FDA-mandated labels themselves, the claim was clearly expressly preempted under Section 360k(a) and Riegel, as effectively seeking to impose labeling requirements in addition to those imposed by the FDA. See id. at 1219. Similarly, the court found that to the extent the claim was construed as premised on alleged misrepresentations and/or omissions in Medtronic’s mandatory reports to the FDA regarding the risk of adverse outcomes from off-label applications of the Infuse device, the claim was clearly impliedly preempted under the reasoning of Buckman, as effectively constituting a claim of fraud on the FDA. See id. at 1220. To the extent the claim could be construed as premised on alleged misrepresentations and/or omissions made by Medtronic to the public and to the plaintiffs physician regarding the safety of off-label applications of the Infuse device, however, the court opined that it “could not be determined” whether the claim was preempted, due to the lack of specificity in the plaintiffs complaint. Id. at 1220. The court indicated that the claim would not be preempted to the extent so premised, so long as a finding of liability on the claim would not require the imposition of labeling requirements beyond those required by the FDA. See id. On that basis, the court denied Medtronic’s motion to dismiss the fraud claim on preemption grounds, see id. at 1219-20, although it nevertheless dismissed the claim on the ground that it was not pled with sufficient particularity to satisfy the heightened pleading requirements of Federal Civil Procedure Rule 9(b), see id. at 1220. The fraudulent misrepresentation and fraud in the inducement claim was the only claim the Caplinger court did not find either expressly or impliedly preempted in its entirety. As to the plaintiffs so-described constructive fraud claim, the court construed the claim as necessarily premised on the allegation that “[sjpecific defects ... in the Infuse® product ... rendered it defective and unreasonably dangerous,” and on that construction found the claim expressly preempted under Section 360k(a) as seeking to impose “design, manufacturing, labeling, warning, and marketing requirements different from, or in addition to, federal requirements for the Infuse Device.” Id. at 1221. Apparently in the alternative, the court additionally found that to the extent the constructive fraud claim was premised on alleged misrepresentations made by a Medtronic representative to the plaintiffs surgeons regarding the safety of the Infuse device during the course of the plaintiffs surgery, the claim was not pled with sufficient particularity and subject to dismissal on ■ that basis as well. See id. at 1220-21. As to the failure to warn claim, the court analyzed the plaintiffs complaint and determined that the claim was premised on the inadequacy of the FDA-mandated warning labels accompanying the Infuse device. See id. at 1221. Without considering or analyzing whether the plaintiffs allegations would support the proposition that the warning labels were inadequate under the FDCA, independently of state law, and thus without analyzing the possibility that the claim could be a “parallel” claim under Riegel, the court found that the claim was therefore necessarily expressly preempted under Section 360k(a) as seeking to impose labeling requirements beyond those required under the FDCA. See id. at 1221-22. As to the defective design claim, the court construed the claim as necessarily premised on the allegation that the device was “unreasonably dangerous, even if defendants complied with all FDA regulations addressed to design.” Id. at 1222. On that construction, the court found- the claim clearly preempted under Section 360k(a) as seeking to “establish design requirements different from, or in addition to, federal requirements for the Infuse Device.” Id. As to the breach of express and implied warranties claims, the court asserted, without analysis, that whether the warranty in question was express or implied, to succeed on a claim of breach the “plaintiff must persuade a jury that the Infuse Device was not safe and effective, a finding that would be contrary to the FDA’s approval.” Although I note that the FDA had not (and has not) approved the Infuse device for all applications and has not characterized the Infuse device as “safe and effective” for off-label applications, and further note that the Caplinger plaintiffs theory of express warranty was based on assurances made by Medtronic not to the FDA or pursuant to FDA mandate but rather in the context of voluntary communications to the public, on the basis of the unsupported assertion that any warranty claim would require contravention of an FDA finding the court, found the claims expressly preempted. See id. at 1222-23. As to the negligence claim, the court analyzed the plaintiffs complaint and determined that the claim was based on three independent factual premises: (i) Medtronic’s failure to warn the plaintiff and her physicians of the risks posed by off-label applications of the Infuse device, (ii) Medtronic’s affirmative promotion and marketing of the Infuse device for unapproved applications, and (iii) Medtronic’s failure to comply with unspecified federal law applicable to the sale and marketing of the Infuse device. See id. at 1222-24. For the same reasons that the court found the plaintiffs failure to warn claim expressly preempted, the court found the negligence claim expressly preempted to the extent premised on a failure to warn. See id. at 1223. To the extent that the negligence claim could be premised on Medtronic’s efforts to market the Infuse device for an off-label application, the court found the claim not expressly preempted because those efforts could constitute misbranding in contravention of the FDCA. See id. However, the court asserted without analysis that such efforts could only be improper by virtue of the FDCA prohibition against misbranding — that is, that such efforts could not be in violation of Oklahoma negligence law absent the FDCA prohibition against misbranding— and on that ground found the claim (to the extent so premised) impliedly preempted under Buckman. See id. To the extent the claim was premised on Medtronic’s violation of unspecified “other” federal law, the court found that the plaintiff had not alleged sufficient facts for the claim to survive a motion to dismiss. See id. Finally, as to the negligent misrepresentation claim, the court construed the claim as necessarily dependent on the proposition that “specific defects in the infuse Device rendered it defective,” and on that basis concluded that to permit' the jury to consider the claim would “risk interference with the federally-approved design, manufacturing, labeling, and warning requirements.” Id. at 1224. In consequence, the court found the claim expressly preempted under Section 360k(a). See id. at 1224-25. Illustrative of cases narrowly construing the preemptive effect of FDA premarket approval is Cornett v. Johnson & Johnson, 414 N.J.Super. 365, 998 A.2d 543 (N.J.App.Div.2010), a decision of the court of appeals of the State of New Jersey. At issue in Cornett was whether claims asserted