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Silver v. Medtronic, Inc.

United States District Court, M.D. Pennsylvania

February 21, 2017

JASON SILVER, Plaintiff,



         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.[1] (collectively “Medtronic”) (Doc. 9). Plaintiff Jason Silver brings seven counts against Medtronic arising out of the alleged malfunction of a Medtronic device, the SynchroMed II.[2] (Doc. 1). The Motion has been fully briefed (Docs. 11, 14, 15) and is therefore ripe for our review. For the reasons that follow, the Motion shall be granted in part and denied in part.

         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, breach of implied warranties, negligent misrepresentation, and violation of Pennsylvania's unfair trade practices and consumer protection law.

         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 cervicalgia. (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, Plaintiff's 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. (Id., 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 Medtronic 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 S.C. 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 S.C. 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).


         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, 515 F.3d 224, 231 (3d Cir. 2008) (quoting Pinker v. Roche Holdings, Ltd., 292 F.3d 361, 374 n.7 (3d Cir. 2002)). In resolving a motion to dismiss pursuant to Rule 12(b)(6), a court generally should consider only the allegations in the complaint, as well as “documents that are attached to or submitted with the complaint, . . . and any matters incorporated by reference or integral to the claim, items subject to judicial notice, matters of public record, orders, [and] items appearing in the record of the case.” Buck v. Hampton Twp. Sch. Dist., 452 F.3d 256, 260 (3d Cir. 2006).

         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, 550 U.S. 544, 555 (2007) (quoting Conley v. Gibson, 355 U.S. 41, 47 (1957)). While a complaint attacked by Rule 12(b)(6) motion to dismiss need not contain detailed factual allegations, it must contain “sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.'” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). To survive a motion to dismiss, a civil plaintiff must allege facts that “raise a right to relief above the speculative level….” Victaulic Co. v. Tieman, 499 F.3d 227, 235 (3d Cir. 2007) (quoting Twombly, 550 U.S. at 555). Accordingly, to satisfy the plausibility standard, the complaint must indicate that defendant's liability is more than “a sheer possibility.” Iqbal, 556 U.S. at 678. “Where a complaint pleads facts that are ‘merely consistent with' a defendant's liability, it ‘stops short of the line between possibility and plausibility of entitlement to relief.'” Id. (quoting Twombly, 550 U.S. at 557).

         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, 550 U.S. at 555, 557. Such allegations are “not entitled to the assumption of truth” and must be disregarded for purposes of resolving a 12(b)(6) motion to dismiss. Iqbal, 556 U.S. at 679. Next, the district court must identify “the ‘nub' of the … complaint - the well-pleaded, nonconclusory factual allegation[s].” Id. Taking these allegations as true, the district judge must then determine whether the complaint states a plausible claim for relief. See id.

         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, 515 F.3d at 231 (citing Twombly, 550 U.S. at 556-57). Rule 8 “does not impose a probability requirement at the pleading stage, but instead simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of the necessary element.” Id. at 234.


         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., 552 U.S. 312, 317 (2008). Class III devices receive the most stringent federal oversight, which is why they are subject to the rigorous PMA process. Id. “The FDA spends an average of 1, 200 hours reviewing each application, and grants premarket approval only if there is ‘reasonable assurance' of the device's ‘safety and effectiveness.'” Id., at 318 (quoting 21 U.S.C. § 360(e)(d)) (internal citation omitted). The MDA “swept back some state obligations and imposed a regime of detailed federal oversight.” Id., at 316. In ...

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