Pappas v. Medtronic Incorporated ( 2021 )

1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA 8 9 Paulina Pappas, No. CV-20-02016-PHX-DLR 10 Plaintiff, ORDER 11 v. 12 Medtronic Incorporated, et al., 13 Defendants. 14 15 16 Before the Court is Defendants’ motion to dismiss, which is fully briefed. (Docs. 17 11, 17, 18.) For the following reasons, the Court will grant Defendants’ motion.1 18 I. Background 19 This case stems from injuries allegedly suffered by Paulina Pappas due to her use 20 of a Medtronic SynchroMed II device (the “Device”) that, after being implanted in 21 December 2014, experienced catheter occlusion, resulting in medication underdosing 22 beginning in October 2018. (Doc. 1 at 2, 7.) The Device, a Class III medical device 23 approved by the U.S. Food and Drug Administration (“FDA”) through the Premarket 24 Approval (“PMA”) process, is a programmable drug infusion system. It consists of 25 infusion pump model no. 867-20 serial no. NGP410483H (the “Pump”) connected to an 26 Ascenda-brand model no. 8781 catheter lot no. N375880002 (the “Catheter”), and was 27 1 The parties’ requests for oral argument are denied because the issues are adequately briefed and oral argument will not help the Court resolve the motion. See Fed. 28 R. Civ. P. 78(b); LRCiv. 7.2(f); Lake at Las Vegas Investors Grp., Inc. v. Pac. Malibu Dev., 933 F.2d 724, 729 (9th Cir. 1991). 1 implanted and attached to Ms. Pappas’ spinal canal to administer pain medication. (Id. at 2 4-6.) After noting the Device’s lack of efficacy since mid-October 2018, on May 9, 2019, 3 Ms. Pappas had the Pump explanted due to pump end-of-life, had the Catheter explanted 4 due to obstruction, and had a new pump and catheter implanted. (Id. at 7.) 5 On October 19, 2020, Ms. Pappas filed a complaint against Defendants— 6 Medtronic, Inc., Medtronic USA, Inc., Medtronic Logistics, LLC, and Medtronic Puerto 7 Rico Operations Company—that brings claims for strict liability manufacturing defect and 8 failure to warn the FDA, negligent manufacturing defect and failure to warn the FDA, 9 negligence per se, breach of implied warranty of merchantability, and breach of implied 10 warranty of fitness for a particular purpose.2 On February 9, 2021, Defendants filed the 11 instant motion to dismiss for failure to state a claim, which is now ripe. 12 II. Legal Standard 13 To survive dismissal for failure to state a claim pursuant to Federal Rule of Civil 14 Procedure 12(b)(6), a complaint must contain factual allegations sufficient to “raise a right 15 to relief above the speculative level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 16 (2007). The task when ruling on a motion to dismiss “is to evaluate whether the claims 17 alleged [plausibly] can be asserted as a matter of law.” See Adams v. Johnson, 355 F.3d 18 1179, 1183 (9th Cir. 2004); see also Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). When 19 analyzing the sufficiency of a complaint, the well-pled factual allegations are taken as true 20 and construed in the light most favorable to the plaintiff. Cousins v. Lockyer, 568 F.3d 21 1063, 1067 (9th Cir. 2009). However, legal conclusions couched as factual allegations are 22 not entitled to the assumption of truth, Iqbal, 556 U.S. at 680, and therefore are insufficient 23 to defeat a motion to dismiss for failure to state a claim, In re Cutera Sec. Litig., 610 F.3d 24 1103, 1108 (9th Cir. 2008). 25 III. Discussion 26 In her response, Ms. Pappas withdrew her failure-to-warn-the-FDA claims (counts 27 2 Ms. Pappas also asserts a claim for punitive damages. The Court does not 28 recognize a stand-alone claim for punitive damages. Rather, punitive damages are a remedy available pursuant to certain claims. 1 III-IV) and implied warranty claims (counts VI-VII.) (Doc. 17 at 3.) The Court will 2 therefore grant Defendants’ motion as to counts 3, 4, 6, and 7 of Ms. Pappas’ complaint. 3 Ms. Pappas’ remaining claims, which are expressly preempted by federal law, are 4 additionally subject to dismissal. 5 The Medical Device Amendments (“MDA”) to the Food, Drug and Cosmetic Act 6 (“FDCA”), 21 U.S.C. § 360k(a), create an exclusive federal regulatory framework 7 applicable to Class III medical devices, including the Device. In Riegel, the Supreme Court 8 established a two-prong test to determine whether claims are expressly preempted by the 9 MDA: (1) whether the FDA has established requirements applicable to the device at issue 10 and (2) whether the claims in the case attempt to impose state requirements relating to 11 safety and effectiveness that are different from, or in addition to the federal requirements. 12 Riegel v. Medtronic, Inc., 552 U.S. 312, 321-23 (2008). The parties agree that the first 13 prong is met, here. Turning to the second prong, the complaint does not allege facts 14 plausibly showing that Defendants deviated from PMA requirements as to the Device, 15 underscoring that the claims must attempt to impose different or additional state 16 requirements. Therefore, express preemption test under Riegel is met. 17 A narrow exception to express preemption under § 360k(a) is recognized for claims 18 that ‘parallel,’ rather than add to, federal requirements. Reigel, 552 U.S. at 330. However, 19 Ms. Pappas has not plausibly pled any parallel claims, here. “Plaintiffs cannot simply 20 incant the magic words ‘Medtronic violated FDA regulations’ in order to avoid 21 preemption.” In re Medtronic Inc. Spring Fidelis Leads Prod. Liab. Litig., 592 F. Supp. 22 2d 1147, 1158 (D. Minn. 2009); see also Thibodeau v. Cochlear Ltd., No. CV-13-02184- 23 PHX-DGC, 2014 WL 3700868, at * 3 (D. Ariz. July 25, 2014) (internal quotations and 24 citation omitted) (“An allegation that the manufacturing processes for the device . . . did 25 not satisfy the [PMA] standards is insufficient to plead a parallel claim if it fails to provide 26 any factual detail to substantiate that crucial allegation.”) Rather, “[t]o properly plead 27 parallel claims that survive preemption, a plaintiff must allege facts (1) showing an alleged 28 violation of FDA regulations or requirements related to [the device], and (2) establishing a 1 || causal nexus between the alleged injury and the violation.” Martin v. Medtronic, Inc., 32 2|| F. Supp. 3d 1026, 1034 (D. Ariz. 2014) (quoting Edison v. Medtronic, Inc., 40 F. Supp. || 1202, 1215 (N.D. Cal. 2014)). Here, Ms. Pappas does not direct the Court to a specific 4|| manufacturing process that fell short of federal requirements or tie such a deficiency to the 5 || Catheter’s obstruction. Instead, she recites a list of regulatory actions, including unrelated || warning letters and recalls regarding catheters that Plaintiff did not use, noting defects she 7\|| does not allege, and addressing complications that she does not claim to have experienced. 8 || Ms. Pappas admits that none of these regulatory actions are applicable to the Catheter, but 9|| asks the Court to speculate that the Catheter nevertheless suffered from some comparable || defect. Ms. Pappas’ complaint fails to state a plausible claim for relief and dismissal is 11 || appropriate. Iqbal, 556 U.S. at 679. 12 IT IS ORDERED that Defendants’ motion to dismiss (Doc. 11) is GRANTED. 13 IT IS FURTHER ORDERED that the Clerk of Court is directed to enter judgment 14]| accordingly and terminate this case. 15 Dated this 15th day of March, 2021. 16 17 18 {Z, 19 {UO 20 Upited States Dictric Judge 21 22 23 24 25 26 27 28 -4-