MEMORANDUM & ORDER
Presently pending before the Court is a motion to dismiss (the “Motion”) filed by Defendants Medtronic, Inc. Medtronic Puerto Rico Operations, Co, and Medtronic Logistics, LLC.
I. BACKGROUND
Plaintiff Jason Silver filed a Complaint against Medtronic on August 12, > 2016. (Doc. 1). Plaintiff brings the following causes of action arising out of the alleged malfunction of Medtronic’s product, the SynchroMed II Device (the ' “Device”): manufacturing defect, failure to warn, negligence, breach of express' warranty,
In accordance with the standard of review applicable to a motion- to dismiss, the following facts are derived from Plaintiff’s Complaint. (Doc. 1).
Plaintiff is a fifty-two year old man with diagnosed cervical radiculopathy and cervi-calgia, (Id., at ¶¶ 10, 12). On December 7, 2012, Plaintiff had the Device, comprised of a pump and an intrathecal catheter, implanted in his abdomen. (Id., at ¶ 13). The Device is a programmable drug infusion system that delivers medication into the intrathecal space of the patient’s spine. (Id., at ¶¶22, 25). It is implanted and remains under the skin. (Id., at ¶ 25).
For several months after the Device was implanted, Plaintiffs pain improved. (Id., at ¶ 14). However, in the summer of 2014, the Device overdelivered pain medication and caused Plaintiff severe, pain, nausea, and lack of mobility. (Id.). On August 12, 2014, Plaintiff underwent a procedure to remove the Device due to its malfunction. (Id., at ¶ 15).
The Device is a Class III medical device approved by the Food and Drug Administration (“FDA”) through the Pre-Market Approval (“PMA”) process in 1988. (M, at ¶ 23), PMA is the FDA’s process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. (Id., at ¶29).' The applicant must supply information to the FDA in a PMA application, (Id., at ¶ 30). The information includes: “a) device description, b) clinical safety trials, c) methods of its product testing, d) design of the ■ device and specific manufacturing controls, e) outcome evaluation, and f) proposed labeling.” (Id.). Medtronic submitted a PMA application and the Device was approved under PMA 860004. (Id., at ¶ 23). Since the original approval, the FDA has approved many changes to the Device. (Id.). Following PMA approval, the holder must comply with certain FDA requirements and federal regulations, including those set out in 21 C.F.R. § 801, et seq., 21- C.F.R, § 803, et seq.,- 21 C.F.R. § 814, et seq., 21 C.F.R. § 806, et seq., 21 C.F.R.- § 820, et seq., and 21 U.S.C. §§ 351-52. (Id., at ¶¶31, 66). The holder must also comply with specifications imposed during the PMA process for the Device. (Id., at ¶ 66).
Starting in 2006, the FDA issued Med-tronic a series of warning letters -identifying federal manufacturing and quality control violations at their -manufacturing plants. (Id., at ¶ 32). On April 27, 2015, the U.S. Department of Justice and ,U.S. Department of Health and Human Services filed a complaint requesting a permanent injunction, leading to a court ordered consent decree “imposing a moratorium on the manufacture, sale, and distribution” of the Device. (Id.).-
The warning letters issued by the FDA identified “Significant Deviations” from Current Good Manufacturing Practices (CGMPs), codified at 21 C.F.R. 820, committed by Medtronic while manufacturing the Device. (Id., at ¶ 36). The letters outlined specific CGMPs that Medtronic failed to follow. (Id.). Due to these deviations, the Device was found to be “adulterated” or “misbranded.” (Id., at ¶¶36, 37, 39)( The FDA also notified Medtronic on multiple occasions of several manufacturing defects in the Device. (Id., at ¶¶41, 46). Since 2008, the FDA has issued nineteen Class I recall actions for the Device to address federal violations. (Id., at ¶ 48).
In addition to manufacturing issues and violations of CGMPs, the FDA notified Medtronic of the following failure to follow their PMA: •
“Regulatory approval was received for Supplement 136 to. PMA P860004 on December 15, 2011 to change the design of SC Catheter models 8709 SC, 8731 SC, 8596 SC, and Revision Kit model 8578 to mitigate a known field, issue associated with, CAPA 1507-SC Catheter Occlusion. This design change was implemented via ECO 12-00985, date March 6, 2012, and the new revisions of Catheter models were released to the field in September 2012. However, the previous SC catheter models which do not conform to the current design have continued to be distributed and have been attributed to 60 complaints of catheter 'occlusion since September 2012.” (Id, at ¶ 47).
On April 27, 2015, the United States Department of Justice and the United States Department of Health and Human Services filed a complaint for a permanent injunction against Medtronic with respect to manufacture of the Device. (Id., at ¶ 52). The complaint alleges that Medtronic is well aware that their practices violate the Act, presumably referring to the CGMPs. (Id., at ¶ 53). The complaint alleged that Medtronic continued to violate 21 U.S.C. §§ 331(a) and (k) by introducing adulterated devices into commerce. (Id., at ¶ 56). On April 27, 2015, the Court signed a consent decree of permanent injunction preventing the manufacture and distribution of the Device. (Id., at ¶ 58). According to Plaintiff, Medtronic continues to produce, distribute, and sell the Device in violation of the.consent decree. (Id., at ¶ 60).
II. STANDARD OF REVIEW
In considering a motion to dismiss pursuant to Rule 12(b)(6), courts “accept all factual allegations as true, construe the complaint in the light most favorable to the plaintiff, and determine whether, under any reasonable reading of the. complaint, the plaintiff may be entitled to relief.” Phillips v. Cty. of Allegheny,
A Rule 12(b)(6) motion tests the sufficiency of the complaint against the pleading requirement of Rule 8(a). Rule 8(a)(2) requires that a complaint contain a short and plain statement of the claim showing that the pleader is entitled to relief, “in order to give the defendant fair notice of what the claim is and the grounds upon which it rests.” Bell Atl. Corp. v. Twombly,
Under the two-pronged approach articulated in Twombly and later formalized in Iqbal, a district court must first identify all factual allegations that constitute nothing more than “legal conclusions” or “naked assertions.” Twombly,
However, “a complaint may not be dismissed merely because it appears unlikely that the plaintiff can prove those facts or will ultimately prevail on the merits.” Phillips,
III. DISCUSSION
Medtronic moves for dismissal on four grounds: all claims are expressly preempted by federal law, all claims are impliedly preempted by federal law, certain claims are inadequately pleaded, and Counts VI and VIII are barred by independent state law grounds. (Doc. 11, p. 6). We will first analyze the federal preemption issue and then discuss each count in turn.
A. Federal Preemption
The Medical Device Amendments of 1976 (“MDA”), codified at 21 U.S.C. § 360, et. seq., established a three-tiered classification system for medical devices, arranged according to the risks presented. Riegel v. Medtronic, Inc.,
“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 Supreme Court considered this preemption provision in Riegel v. Medtronic, Inc,
• The-parties do not dispute that the first prong of-the Riegel test is satisfied. (Doc, 14, p. 8). The Device-was subject to pre-market approval and is thus governed by the specific requirements set forth in the PMA, as well as federal regulations. (Doc. 1, ¶¶.23, 31). Whether Plaintiffs claims are expressly preempted by federal law, therefore, “requires, the court to evaluate whether the state requirements underlying the plaintiffs claims- relate to the device’s safety and effectiveness and are ‘different from or in addition to’ the federal requirements.” Gross,
Plaintiffs claims undoubtedly :meet the first requirement: his claims arise out of alleged issues with the safety and effectiveness of the Device. However, Medtronic asserts that Plaintiffs claims are based on state law that is different from or additional to federal law. (Doc. 11, p. 9). In response, “Plaintiff asserts that his pump was manufactured in violation of federal law and parallel state law, was nonconforming .with- FDA-approved standards making it ¡misbranded and adulterated and therefore defective.” (Doc. 14, p. 8).
The Supreme Court made expressly clear in Reigel that state law claims are not universally preempted:
“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)(l). 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.”
Riegel,
Medtronic argues that CGMPs do not provide a parallel “federal requirement” to excuse Plaintiffs claims from preemption because they, are too general and inherently flexible. (Doc. 11, p. 12). Several courts have dismissed claims premised on violations of CGMPs for this very reason.
However, other courts have allowed claims based on CGMP violations to proceed. See Bausch v. Stryker Corp.,
Here, Plaintiff did not simply provide a “laundry list of alleged CGMP violations”, as Medtronic argues. (Doc. 11, p. 12). Instead, Plaintiff cites to FDA warning letters that delineate specific CGMPs and exactly how Medtronic was in noncompliance. (Doc, 1, ex. 2-5). The letters provide specific facts to support the FDA’s conclusion that Medtronic was in violation of certain CGMPs. There is nothing vague or open ended about these asserted violations, and as the. FDA warning letters demonstrate, the CGMP violations alleged are certainly not too general to be capable of enforcement. Thus, we hold that the CGMP violations alleged qualify as “federal regulations” from which a parallel state claim may be made. These allegations undoubtedly establish violations of federal regulations sufficient to withstand Twom-bly’s plausibility. pleading standard. So long as Plaintiffs state claims are premised upon these federal regulations and parallel state law, rather than duties that differ from or add to this regulatory
Medtronic next argues that Plaintiffs claims are impliedly preempted as well. Medtronic reliés the Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Comm.,
In Buckman, the plaintiffs brought suit alleging that a regulatory consultant to the manufacturer of a medical device made fraudulent representations to the FDA in order to obtain premarket approval. Buck-man,
Having disposed of Medtronic’s implied preemption argument, and the overriding argument that the violations alleged by Plaintiff do not constitute violations of “federal regulations”, we now turn to each claim to analyze whether it properly states a parallel claim to survive dismissal.
B. Count I — Manufacturing Defect
Plaintiff alleges that Medtronic “had a duty under Pennsylvania law to use reasonable- care in the manufacture of their products,” which includes compliance with their own PMA specifications and federal regulations. (Doc. 1, ¶ 67). Plaintiff alleges that Medtronic breached his Pennsylvania common law duty to exercise reasonable care in manufacturing the Device in failing to ensure that the Device conformed to its own PMA specifications and complied with CGMPs. (Id., at ¶ 68). As a result of .these violations, Plaintiff alleges that his “adulterated” device was unreasonably dangerous and caused him harm. (Id., at ¶¶ 69-74). Regarding preemption, it is clear that Plaintiff is asserting a parallel claim, as he alleges that the Device is unreasonably dangerous because of the federal failures, rather than in spite of them.
Medtronic argues that, even if Plaintiffs theories support a parallel claim, Count I must fail because “Plaintiff cannot show that any of the regulatory actions cited in his Complaint” plausibly caused his injuries. (Doc. 11, p. 13). We disagree. Plaintiff has cited to the FDA warning letters, including three specifically outlining failures of CGMPs at the Minneapolis, Minnesota manufacturing facility. (Doc. 1, ex. 3-5). Plaintiff has further alleged that his De
C. Count II — Failure to Warn
In Count II, Plaintiff alleges that Medtronic breached its “duty to disclose to users and purchasers, including the FDA, of potentially dangerous risks involved in their product’s use” through their failures to report known problems, consumer generated adverse events, and malfunctions of the Device, and failure to submit mandated Medical Device Reports to the FDA. (Doc. 1, ¶¶ 79-80).
Medtronic argues that Plaintiffs failure to warn claim is expressly preempted to the extent that it attempts to hold Med-tronic liable for not providing additional warnings outside of FDA requirements. (Doc. 11, pp. 9-10). Plaintiff does not respond to this portion of Medtronic’s argument, likely because Plaintiff is well aware that the imposition of additional warning requirements would be expressly preempted by the MDA. Upon review of Count II, it is clear that Plaintiffs claim rests on Medtronic’s alleged failures to report problems with the Device to the FDA as mandated by 21 C.F.R § 803, et. seq., which requires Class III device manufacturers to “report deaths and serious injuries that a device has or may have caused or contributed to,' establish and maintain adverse event files, and submit summary annual reports.” 21 C.F.R. § 803.1; (Doc. 1, ¶¶ 78-80). Thus, the claim does not seek to impose additional warning requirements on Medtronic and would not be expressly preempted.
Medtronic argues that Plaintiffs claim cannot rest on its alleged failure to report to the FDA because it is expressly preempted, the reports’ do not constitute “warnings”, and the reports are not automatically disclosed to the public. Beginning with express preemption, Medtronic argues that a Pennsylvania failure to'warn claim imposes additional or different requirements on PMA device manufacturers because it requires manufacturers to provide warnings to the physicians, - whereas federal law requires only that the manufacturer submit information to 'the FDA. (Doc. 11, p. 10). Plaintiff responds that Medtronic “misses the point” because, in practice, the FDA posts the manufacturer’s Medical Device Reports to a publicly accessible database as a-means of warning the public and physicians. (Doc. 14, pp. 10-11).
While there is no binding jurisprudence on whether a Pennsylvania failure to warn claim premised upon the manufacturer’s failure' to report to the FDA is expressly preempted by the MDA, Plaintiff points to the well-reasoned decision of our sister court in the Eastern District. In McLaughlin v. Bayer Corporation, the court faced an essentially identical situation wherein- the complaint set forth a failure to warn claim against a PMA manufacturer based on its failure to report adverse events to the FDA. McLaughlin v. Bayer Corp.,
Just as in McLaughlin, Plaintiff here provides evidence that Pennsylvania law imposes such a duty. McLaughlin,
“[A] supplier’s duty to warn is discharged by providing information about the product’s dangerous propensities to a third person upon whom it can reasonably rely to communicate the information to the ultimate users of the product or those who may be exposed to its hazardous effects.
Phillips,
D. Count III — Negligence
Plaintiffs negligence claim is very similar to Count I for manufacturing defect, evidenced by the fact that Medtronic argues against both Counts I and III simultaneously in its brief. Accordingly, we will deny Medtronic’s motion- to dismiss Count III for the same reasons: the claim alleges that Medtronic breached- its Pennsylvania common law duty to exercise reasonable-care in its failure to comply with federal regulations (Doc. 1, ¶¶-89-90), that the ’failure to follow federal regulations resulted in the Plaintiff receiving an adulterated device (Id., at ¶94), and that the device caused his injuries. (Id.). Considering the specific federal violations alleged through the FDA warning letters, and taking Plaintiffs allegations as true, Plaintiff has properly pled a plausible claim for negligence.
E. Count V — Breach of Express Warranty
Medtronic argues that “any warranty claim that challenges the safety or effectiveness of a medical device that has received premarket approval ... is expressly preempted by § 360k(a)” because it would require a finding that the device is not safe and effective, contrary to the finding made by the FDA in granting pre-market approval. (Doc. 11, pp. 13-14).
Plaintiffs breach of express warranty claim is beyond the .scope of federal preemption. As the Eastern District recognized in Bentzley v. Medtronic, Inc.,
F. Count VI — Breach of ■ Implied Warranties
Plaintiff advances both a claim for breach of the implied warranty of fitness for a particular purpose and breach of the implied warranty of merchantability. (Doc. 14, p. 13). Medtronic argues that’Count VI should be dismissed because it is preempted by the MDA and barred by Pennsylvania law. (Doc. 11, pp. 13, 14, 20).
Medtronic points to Horsmon v. Zimmer Holdings, Inc.,
Plaintiff failed to address Medtronic’s Pennsylvania law argument for Count Vi’s dismissal. As such, we will accept Med-tronic’s and other courts’, interpretations that Pennsylvania would not allow an implied warranty claim' against a medical device manufacturer. Because this issue is dispositive, we will not consider the federal preemption arguments and shall dismiss Count VI. -
G. Count VII — Negligent Misrepresentation
Medtronic moves to dismiss Plaintiffs negligent misrepresentation claim because it is preempted by the MDA and Plaintiff has not adequately pled a misrepresentation claim under Federal Rule of Procedure 9(b). (Doc. 11, pp. 14,19). Plaintiff does not address Medtronic’s adequacy of pleading argument.
District Courts in our Circuit have come to differing conclusions on whether Rule 9(b)’s heightened pleading' requirements for fraud, or mistake apply to claims of negligent misrepresentation. Bors v. Johnson & Johnson, No. CV 16-2866,
In the eight paragraphs that comprise Count VII for negligent misrepresentation, Plaintiff fails to identify any specific representation that was allegedly negli
H. Count VIII — Pennsylvania Unfair Trade Practices and Consumer Protection Law
In Count VIII, Plaintiff alleges that Medtronic violated Pennsylvania’s Unfair Trade Practices and Consumer Protection Law, 73 P.S. § 201-1, et. seq., by “knowingly and intentionally inducting] [Plaintiff] to use the SynchroMed II Device through the use of false and or/misleading representations and statements.” (Doc. 1, ¶ 121). Medtronic moves for dismissal, arguing that the claim is preempted, inadequately pled under Rule 9(b), and barred by the learned intermediary doctrine. (Doc. 11, pp. 14-15, 19, 20). Plaintiff did not offer any response to the pleading or learned intermediary doctrine argument.
Again, we need not even consider Rule 9(b) to hold that Plaintiffs pleading of Count VIII is wholly inadequate. Just as in Count VII, Plaintiffs claims rest on allegedly misleading representations and statements, and yet he fails to point to any specific representation. The claim is entirely conclusory, stating generally that Med-tronic made “false and misleading oral and written statements” that misled customers. (Doc. 1, ¶ 123(a)). In an attempt to provide examples, the complaint states that Med-tronic made representations stating that the Device had certain characteristics that it did not, but again failed to point to any such representations or statements. (Id., at ¶ 123(b)-(d)). Count VIII cannot survive dismissal in face of such factual deficiencies. As such, we will grant Medtronic’s motion to dismiss Count VIII and need not reach the preemption or learned intermediary issues.
IV. CONCLUSION
For the foregoing reasons, Medtronic’s motion to dismiss will be granted in part and denied in part.
NOW, THEREFORE, IT IS HEREBY ORDERED THAT:
1., Medtronic’s motion to dismiss will be GRANTED IN PART and DENIED in part.
a. The motion is GRANTED with respect to Counts VI, VII, and VIII.
b. The motion is DENIED with respect to Counts I, II, III, and V.
2. The Clerk is directed to TERMINATE Medtronic Nueromodulation, . Inc. as a Defendant in this action and AMEND Defendant “Medtronic Puerto Rico Operations, Inc.” to “Medtronic Puerto Rico Operations, Co.”
Notes
. Plaintiff named "Medtronic -Nueromodulation” as a Defendant, but-Medtronic asserts that this is just a division of Medtronic, Inc., as opposed to a separate legal entity. (Doc. 9, p. 1). Plaintiff also named Defendant “Med-tronic Puerto Rico Operations, Inc,” but Defendants state that its name is "Medtronic Puerto Rico Operations, Co.” (Id.). Plaintiffs did not contest these statements and we shall refer to the Defendants in this way and direct the Clerk-to remove Medtronic Nueromodulation as a,separate Defendant. ,■ -
. Plaintiff brings seven claims numbered Counts I, II, III, V, VI, VII, VIII. There is no Count- IV. We will refer to each of Plaintiff’s claims by the number assigned to it in- his Complaint.
. See, e.g., In re Medtronic Inc. Sprint Fidelis Leads Prods. Liab. Litig, 592 F.Supp.2d 1147,-1157 (D. Minn. 2009); James v. Diva Int’l, Inc.,
. Citing Cogswell v. Wright Med.Tech., Inc.,