Perez v. Medtronic Incorporated et al

MOTION to Dismiss Case

D. Ariz.July 5, 2017

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 EAST\144933839.1 Mark A. Nadeau (Bar No. 011280) mark.nadeau@dlapiper.com Cole J. Schlabach (Bar No. 026364) cole.schlabach@dlapiper.com DLA PIPER LLP (US) 2525 East Camelback Road, Suite 1000 Phoenix, AZ 85016-4232 Tel: 480.606.5100 Fax: 480.606.5101 Keiko L. Sugisaka (MN #0266152) (pro hac vice pending) keiko.sugisaka@maslon.com MASLON LLP 3300 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402-4140 Tel: 612.672.8200 Fax: 612.672.8397 Attorneys for Defendants Medtronic, Inc.; Medtronic Neuromodulation, a division of Medtronic, Inc.; Medtronic Puerto Rico Operations Co.; Medtronic USA, Inc.; and Medtronic Logistics, LLC UNITED STATES DISTRICT COURT FOR THE DISTRICT OF ARIZONA Monica L. Perez, individually and on the behalf of beneficiaries for the Estate of Francisco C. Perez (deceased), Plaintiff, vs. Medtronic, Inc.; Medtronic Neuromodulation, a division of Medtronic, Inc.; Medtronic Puerto Rico Operations Co.; Medtronic USA, Inc.; and Medtronic Logistics, LLC, Defendants. Case No. 2:16-cv-02896-ROS DEFENDANTS’ RULE 12(B)(6) MOTION TO DISMISS PLAINTIFF’S FIRST AMENDED COMPLAINT AND MEMORANDUM OF LAW IN SUPPORT OF MOTION Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 1 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 i EAST\144933839.1 TABLE OF CONTENTS I. INTRODUCTION ...................................... .................................................... 1 II. BACKGROUND ................................................................................................ 1 A. Plaintiff’s Claims Are Subject to Express and Implied Preemption. ............ 1 B. Medtronic’s First Motion to Dismiss. ........................................................... 1 C. Plaintiff’s First Amended Complaint. ...................................................... 2 III. LEGAL STANDARD ........................................................................................ 3 IV. ARGUMENT ..................................................................................................... 3 A. Plaintiff’s Failure to Warn Claim Is Expressly Preempted and Fails to State a Parallel Claim. ..................................................................... 5 1. Plaintiff’s failure to warn claim is expressly preempted to the extent it is based on an alleged failure to warn Mr. Perez or his physicians. .............................................................................. 5 2. Plaintiff’s failure to warn claim is inadequately pleaded because it fails to make causation plausible........ ........................ 6 B. Plaintiff’s Manufacturing Defect and Negligence Claims Are Impliedly Preempted and Inadequately Pleaded. ........ ........................... 11 1. Plaintiff’s manufacturing defect and negligence claims are impliedly preempted......................................................................... 11 2. Plaintiff’s manufacturing defect and negligence claims are inadequately pleaded. ................................................................ 13 V. CONCLUSION ............................................................................................ 14 Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 2 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 ii EAST\144933839.1 TABLE OF AUTHORITIES Page CASES Aaron v. Medtronic, Inc., No. 1:13-cv-301, 2016 WL 5242957 (S.D. Ohio Sep. 22, 2016) .................................. 5 Arvizu v. Medtronic, Inc., 41 F. Supp. 3d 783 (D. Ariz. 2014) ................................................................ 4, 6 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ...................................................................................... 3, 13 Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021 (D. Haw. 2014) ............................................................. 6, 8 Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) ...................................................................................... 3, 13 Blankenship v. Medtronic, Inc., 6 F. Supp. 3d 979 (E.D. Mo. 2014) .......................................................................... 4 Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) .............................................................................. 1, 4, 5, 11 Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206 (W.D. Okla. 2013) .......................................................... 4 De La Paz v. Bayer Healthcare LLC, 159 F. Supp. 3d 1085 (N.D. Cal. 2016) ........................................................ 7, 8, 14 Edwards v. Marin Park, Inc., 356 F.3d 1058 (9th Cir. 2004) .......................................................................... 10 Erickson v. Bos. Sci. Corp., 846 F. Supp. 2d 1085, 1089 (C.D. Cal. 2011) ..................................................... 1, 5, 13 Franzese v. St. Jude Med., Inc., No. 13-CV-3203 JS WDW, 2014 WL 2863087 (E.D.N.Y. June 23, 2014) ................ 14 Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 3 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 iii EAST\144933839.1 Frere v. Medtronic, Inc., No. EDCV 15-02338-BRO (DTBx), 2016 WL 1533524 (C.D. Cal. April 6, 2016) .................................................................................................... 12, 14 Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000) .......................................................................................... 11 Hawkins v. Medtronic, Inc., No. 1:13-CV-00499 AWI SKO, 2014 WL 346622 (E.D. Cal. Jan. 30, 2014) .............. 8 Herrnandez v. Stryker Corp., No. C14-0613RSM, 2014 WL 7044171, at *6 (W.D. Wash. Dec. 11, 2014) ............. 14 Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal. 2013) ......................................................... 4, 6 In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147, 1161 (D. Minn. 2009), aff’d sub nom. Bryant v. Medtronic, Inc., 623 F.3d 1200 (8th Cir. 2010) ..................................... 11 Johnson v. Hologic, Inc., No. 2:14-CV-0794-JAM-KJN, 2015 WL 75240 (E.D. Cal. Jan. 6, 2015) .................... 8 Leonard v. Medtronic, Inc., No. 1:10-CV-03787-JEC, 2011 WL 3652311 (N.D. Ga. Aug. 19, 2011) ................... 11 Lutz-Cummings v. Medtronic, Inc., No. 27-CV-15-16417, 2016 WL 3082314 (Minn. Dist. CtMay 31, 2016) ............... 14 Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. 2012) ............................................................................ 11 Martin v. Medtronic, Inc., 32 F. Supp. 3d 1026 (D. Ariz. 2014) (“Martin I”) ........................................... 4, 6, 8, 13 Martin v. Medtronic, Inc., 63 F. Supp. 3d 1050 (D. Ariz. 2014) (“Martin II”) ....................................................... 8 Martin v. Medtronic, Inc., No. 1:15-cv-00994-DAD-MJS, 2017 WL 825410 (E.D. Cal. Feb. 24, 2017) ............ 12 Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 4 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 iv EAST\144933839.1 Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ............................................................................................ 5 Millman v. Medtronic, No. 14-cv-1465, 2015 WL 778779 (D.N.J. Feb. 24, 2015) ..................................... 5, 13 Otis-Wisher v. Medtronic, Inc., 616 F. App’x 433 (2d Cir. 2015) ......................................................................... 5 Parker v. Stryker Corp., 584 F. Supp. 2d 1298 (D. Colo. 2008) ............................................................. 13 Perez v. Nidek Co., 657 F. Supp. 2d 1156 (S.D. Cal. 2009) ............................................................ 11 Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013) .................................................................. 4, 6, 12 Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ................................................................................ 1, 3, 4, 5 Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minn. 2009) ................................................................. 4 Scovil v. Medtronic, Inc., 995 F. Supp. 2d 1082 (D. Ariz. 2014) ................................................................ 6 Simmons v. Bos. Sci. Corp., No. CV 12-7962 PA (FFMx), 2013 WL 1207421 (C.D. Cal. Mar. 25, 2013) ............. 8 Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) ................................................................... passim Thibodeau v. Cochlear Ltd., No. CV-13-02184-PHX-DGC, 2014 WL 3700868 (D. Ariz. July 25, 2014) ............. 12 White v. Stryker Corp., 818 F. Supp. 2d 1032 (W.D. Ky. 2011) .............................................................. 5 Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) .......................................................................... 4 Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 5 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 v EAST\144933839.1 Yosowitz v. Covidien LP, 182 F. Supp. 3d 683 (S.D. Tex. 2016) ............................................................. 12 STATUTES 21 C.F.R. § 803.50.................................................................................................... 5 21 U.S.C. § 337(a) .......................................................................................... 1, 5, 11 21 U.S.C. § 360k(a) ......................................................................................... passim 21 U.S.C. § 360k(a)(1) ............................................................................................. 3 OTHER AUTHORITIES Fed. R. Civ. P. 12(b)(6) ............................................................................................ 1 Fed. R. Evid. 201(b) ................................................................................................. 1 Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 6 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 EAST\144933839.1 I. INTRODUCTION Plaintiff’s First Amended Complaint (“FAC” [Doc. 30]) only seeks to amend her failure to warn claim, but the Court should dismiss thi claim because it is expressly preempted (in part) and inadequately pleaded (in its en irety). Additionally, the Court should dismiss Plaintiff’s manufacturing defect and negligence claims because they are impliedly preempted and inadequately pleaded. Therefore, pursuant to Federal Rule of Civil Procedure 12(b)(6), Medtronic respectfully moves for dismissal of all claims brought against it with prejudice and without leave to amend. II. BACKGROUND A. Plaintiff’s Claims Are Subject to Express and Implied Preemption. As set forth in this Court’s Order on Medtronic’s first motion to dismiss (“Mot. to Dismiss”) and as Plaintiff admits, Medtronic’s SynchroMed® II Infusion System is a Class III premarket-approved medical device, and Plaintiff’s claims are thus subject to both express preemption under 21 U.S.C. § 360k(a) and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and implied preemption under 21 U.S.C § 337(a) and Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). (Or. on Mot. to Dismiss [Doc. 25] at 4- 5; FAC [Doc. 30] ¶¶ 101, 107; see also Mot. to Dismiss [Doc. 18] and Exs. A-C thereto.)1 Given the Court’s familiarity with preemption and Plaintiff’s admission that it applies here, Medtronic will not repeat the full regulatory background here. B. Medtronic’s First Motion to Dismiss. Plaintiff Monica Perez (“Plaintiff” or “Monica”) filed her original Complaint on August 29, 2016, alleging her husband Francisco Perez (“Mr. Perez” or “Francisco”) died due to an alleged failure of his SynchroMed® II devic and asserting claims for manufacturing defect, failure to warn, negligence, negligence per se, breach of express and implied warranties, negligent misrepresentation, and violation of Minnesota and 1 The Court may again take judicial notice of the FDA’s PMA documents because they are government records that are not subject to reasonable dispute. See Fed. R. Evid. 201(b); Erickson v. Bos. Sci. Corp., 846 F. Supp. 2d 1085, 1089 (C.D. Cal. 2011). Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 7 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 2 EAST\144933839.1 Arizona consumer protection statutes. (See generally Compl. [Doc. 1].) Medtronic filed a motion to dismiss all but part of one claim on November 1, 2016, asserting federal preemption, inadequate pleading and other defenses.2 (Doc. 18.) On May 26, 2017, the Court granted Medtronic’s motion in part and denied it in part. (Doc. 25.) The Court dismissed Counts V, VI, VI VIII, IX, X and XI because Plaintiff did not respond to Medtronic’s arguments for their dismissal. (Id. at 3.) The Court denied Medtronic’s motion to dismiss Plaintiff’s claims for manufacturing defect and negligence (Counts I and III) as expressly preempt d, to the extent those claims are based on alleged violation of Current Good Manufacturing Practice (“CGMPs”).3 (Id. at 6-7, 9.) However, the Court did not decide whether claims were impliedly preempted or inadequately pleaded. (Id. at 7 n.3.) Next, the Court dismissed Plaintiff’s failure to warn claim (Count II) based on alleged failure to report adverse events because Plaintiff did not adequately plead causation. (Id at 8-9.) Last, the Court dismissed Plaintiff’s negligence per se claim (Count IV) as impliedly preempted because it was based on federal regulations. (Id. at 9.) C. Plaintiff’s First Amended Complaint. Plaintiff filed her FAC on June 27, 2017. (Doc. 30.) As Plaintiff explained in her motion for leave to file the FAC, the FAC includes the same manufacturing defect and negligence claims (Counts I and III), and amends only her failure to warn claim (Count II). (Doc. 26 at 2.) Specifically, Plaintiff argues the new allegations in her FAC clear the Stengel v. Medtronic, Inc. “causation hurdle” requiring that the allegations “e tablish[] that ‘if Medtronic had properly reported the adverse events to the FDA as required under federal law, that information would have reached [Francisco’s] doctors in time to prevent 2 Medtronic did not move to dismiss on express preemption grounds Plaintiff’s manufacturing defect claim (Count I) insofar as it rested on alleged violations of the device-specific requirements set forth in the devic’s PMA. (See Or. at 6 [Doc. 25]; Mot. to Dismiss [Doc. 18] at 8, n.4.) 3 Medtronic respectfully maintains that the manufacturing defect and negligence claims are expressly preempted. Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 8 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 3 EAST\144933839.1 his injuries.’” (Id. at 6 (citing Or. [Doc. 25] at 8, in turn citing, Stengel v. Medtronic, Inc. 704 F.3d 1224, 1234 (9th Cir. 2013) (Watford, J., concurring))). However, rather than adding any factual allegations plausibly suggesting that Medtronic’s alleged failure to report adverse events to the FDA somehow caused Mr. Perez’s death, the FAC solely adds allegations concerning Mr. Perez’s physician’s alleged interactions with Medtronic (FAC ¶¶ 40-41, 4-49, 53-54, 172-175) and a single allegation that Mr. Perez would not have died if Medtronic had reported “information” to the FDA regarding Mr. Perez’s own device (id. at ¶ 175). III. LEGAL STANDARD To survive a motion to dismiss under Rule 12(b)(6), Plaintiff’s Complaint must contain “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). “[N]aked assertion[s] devoid of further factual enhancement” do not suffice. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quotation omitted). Dismissal is required “[w]here a complaint pleads facts that are ‘merely consistent with’ a defendant’s liability” and “where the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct.” Id. at 678-79 (quoting Twombly, 550 U.S. at 557) (emphasis added). IV. ARGUMENT As this Court held, 21 U.S.C. § 360k(a)(1) preempts “any ‘state requirements different from, or in addition to, any requirement applicable . . . to the device under federal law.’” (Or. at 5, [Doc. 25] (citing Riegel, 552 U.S. at 321, in turn quoting, 21 U.S.C. § 360k(a)(1)).) Congress adopted § 360k(a) to “swe[ep] back some state obligations and impose[ ] a regime of detailed federal oversight,” enforced by an expert federal agency rather than private plaintiffs and lay juries. Riegel, 552 U.S. at 316. Although § 360k(a)’s broad preemption may leave some individuals “without . . . judicial recourse,” the loss to those comparatively few individuals was, in Congress’s estimation, outweighed by the benefit to the far greater number “who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 9 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 4 EAST\144933839.1 innovations.” Id. at 326 (internal quotations omitted). As an alternative to private tort actions, Congress gave the FDA substantial authority t police and sanction device manufacturers under federal law. See Buckman, 531 U.S. at 349. In addition to express preemption, a state law claim is impliedly preempted under the MDA where it seeks to enforce an exclusively federal requirement, and is not based on “traditional state tort law.” Id. at 353; (see Or. at 5 [Doc. 25] (citing Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013)) (“[I]f a claim exists ‘solely by virtue’ of federal law . . . , it is impliedly preempted.”).) “Claims not tied to state law tort duties are essentially private actions to enforce the FDCA and re barred by Section 337(a).” Martin v. Medtronic, Inc., 32 F. Supp. 3d 1026, 1034 (D. Ariz. 2014) (“Martin I”) (internal citations and quotations omitted); see also Arvizu v. Medtronic, Inc., 41 F. Supp. 3d 783, 788 (D. Ariz. 2014) (internal quotations omitted) (citing Perez, 711 F.3d at 1120) (to avoid preemption, the plaintiff “must be suing for conduct that violates the FDCA but also must not be suing because the conduct violates the FDCA”). Further, to survive implied preemption under § 337(a), a claim must not only be premised on a traditional state-law duty, but also on “‘the type of conduct that would traditionally give rise to liability under state law.’” Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1175 (C.D. Cal. 2013) (emphasis altered) (quoting Riley v. Cordis Corp., 625 F. Supp. 2d 769, 776- 77 (D. Minn. 2009)); see also Martin I, 32 F. Supp. 3d at 1038 (quoting Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206, 1214 (W.D. Okla. 2013)) (same); Blankenship v. Medtronic, Inc., 6 F. Supp. 3d 979, 986 (E.D. Mo. 2014) (same). As such, there is only a narrow exception to express preemption for claims that “‘parallel,’ rather than add to, federal requirements.” Riegel, 552 U.S. at 330. But Plaintiff must plead facts supporting such a claim and “cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in orde to avoid preemption.” Wolicki- Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) (quotation omitted). Moreover, it is not enough that a claim be based on a violation of federal law. Rather, to be “parallel,” a claim must rest on the violation of a state-law requirement that is Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 10 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 5 EAST\144933839.1 “identical” to an existing federal requirement. Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996); accord Otis-Wisher v. Medtronic, Inc., 616 F. App’x 433, 434 (2d Cir. 2015). Establishing liability via a parallel claim is thus “more difficult than it would be in a typical product liability case.” White v. Stryker Corp., 818 F. Supp. 2d 1032, 1037 (W.D. Ky. 2011). “To state a ‘parallel’ claim, a plaintiff must allege (1) the violation of a specific federal requirement applicable to the device; (2) the violation of an identical state-law duty; and (3) that the predicate federal violation caused his or her injuries.” Millman v. Medtronic, No. 14-cv-1465, 2015 WL 778779, at *4 n.2 (D.N.J. Feb. 24, 2015) (emphasis added); see also, e.g., Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994, 1000 (S.D. Ohio 2016); Erickson, 846 F. Supp. 2d at 1092. Plaintiff’s FAC fails to satisfy this rigorous standard. A. Plaintiff’s Failure to Warn Claim Is Expressly Preempted and Fails to State a Parallel Claim. 1. Plaintiff’s failure to warn claim is expressly preempted to the extent it is based on an alleged failure to warn Mr. Perez or his physicians. This Court held that, under Stengel, a failure to warn claim may survive express preemption if it is based on alleged failure to inform the FDA of adverse events as required by 21 C.F.R. § 803.50, and the allegations “establish[] that ‘if Medtronic had properly reported the adverse events to the FDA as required under federal law, that information would have reached [Francisco’s] doctors in time to prevent his injuries.’” (Or. at 8, [Doc. 25] (citing Stengel, 704 F.3d at 1233; 1234 (Watford, J., concurring)).) 4 The Stengel court reasoned that the federal requirement to submit adverse event reports to the FDA paralleled the Arizona state law failure to warn duty to warn third parties. Stengel, 704 F.3d at 1233. 4 Although this Court is bound by Stengel, Medtronic respectfully submits Stengel was wrongly decided and claims predicated on an alleged failure to submit adverse-event reports to the FDA are expressly preempted by 21 U.S.C. § 360k(a) as interpreted in Riegel and impliedly preempted by 21 U.S.C. § 337(a) as interpreted in Buckman. Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 11 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 6 EAST\144933839.1 As stated above, however, all but one of the new alleg tions in the FAC relate not to Medtronic’s adverse event reporting to the FDA, but rather to Mr. Perez’s physician’s alleged interactions with Medtronic. Indeed, the gist of Plaintiff’s new allegations is that “Medtronic did not provide Dr. Bernstein with [certain] information.” (FAC ¶ 46 (emphasis altered); see also id. at ¶ 49 (accusing Medtronic of “withholding critical safety information from [Dr. Bernstein]”). Further, Plaintiff does not allege Medtronic failed to provide any PMA-required warning to Mr. Perez’s physician. Therefore, Plaintiff’s failure to warn claim based on Medtronic’s alleged interactions with Mr. Perez’s physicians is expressly “preempted because [it] would require [Medtronic] to take actions that are different from or in addition t the requirements imposed by federal law.” Arvizu, 41 F. Supp. 3d at 792 (dismissing failure to warn claim as expressly preempted where “the majority of Plaintiffs’ allegations are that Defendants failed to warn them and their physicians”). The concurrence i Stengel “took care to note that ‘had the plaintiffs predicated their claim on a failure to warn doctors directly—an action not required by FDA regulations—that claim would have been preempted because it would have been an addition to the federal requirement.’” Houston, 957 F. Supp. 2d at 1175 (emphasis original) (citing Perez, 711 F.3d at 1118, in turn citing Stengel, 704 F.3d at 1234 (Watford, J., concurring)); see also, e.g., Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021, 1039 (D. Haw. 2014) (finding a claim for failure to warn doctors preempted because it would seek “to impose on Defendants a duty to provide warnings beyond those already outlined by the FDA”); Scovil v. Medtronic, Inc., 995 F. Supp. 2d 1082, 1095-96 (D. Ariz. 2014) (same); Martin I, 32 F. Supp. 3d at 1041-43 (same). As such, the Court should dismiss Plaintiff’s failure to warn claim to the extent it is based on Medtronic’s alleged interactions with Mr. Perez and his physicians. 2. Plaintiff’s failure to warn claim is inadequately pleaded because it fails to make causation plausible. Plaintiff’s FAC (like her original Complaint) also alleges that Medtronic failed to report (unidentified) adverse events to the FDA. (See, e.g., FAC ¶ 168.) As this Court Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 12 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 7 EAST\144933839.1 already held once, however, these allegations do not save her failure to warn claim because they lack facts making causation plausible. As the Court explained, “a failure to warn claim based on the failure to provide reports to the FDA presents a unique ‘causation hurdle.’” (Or. at 8 [Doc. 25] (citing Stengel, 704 F.3d at 1234 (Watford, J. concurring)).) “Absent clear factual allegations establishing causation . . . the failure to warn claim must be dismissed.” (Id. at 9.) Establishing causation requires showing “that Medtronic’s failure to disclose to the FDA other unidentified information would have led the FDA to take action such that Francisco’s doctors would have taken action in time to avoid Francisco’s death.” (Id.) In other words, to sufficiently allege that Mr. Perez’s death was proximately caused by Medtronic’s alleged violation of the federal adverse-event reporting requirements, Plaintiff must allege facts that, if rue, would establish each and every link in the following causal chain: (1) Medtronic knew of relevant adverse events that it did not report to the FDA; (2) if the events had been repo ted to the FDA, the agency would have made the reports available to doctors; (3) if the FDA had made the reports available, Mr. Perez’s doctors would have seen them prior to his death; and (4) if Mr. Perez’s doctors would have seen the reports, they would have altered their conduct in a way that would have prevented Mr. Perez’s death. Plaintiff does not even baldly allege such facts, much less allege facts that would make the causal chain plausible, rather than merely speculative. In fact, the FAC does not add any new allegations supporting such a causal chain. As this Court did when faced with the same allegations in Plaintiff’s original Complaint, district courts in the Ninth Circuit routinely dismiss claims based on failure to report adverse events when plaintiffs merely allege they would not have been injured had the adverse events been reported. For example, in De La Paz v. Bayer Healthcare LLC, 159 F. Supp. 3d 1085 (N.D. Cal. 2016), the plaintiff, like Plaintiff here (see FAC ¶¶ 157, 176), alleged that “she never would have had [the device] implanted” if “she had known of these adverse events . . . .” Id. at 1097. Nevertheless, the court dismissed the claim Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 13 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 8 EAST\144933839.1 because plaintiff “pled no facts that plausibly indicate that she or her physician would have become aware of these adverse events if [defenant] had timely reported them to the FDA.” Id. “Thus, [plaintiff] has failed to plausibly show that her injuries would have been prevented if [defendant] had properly reported th . . . events—a necessary element of her failure-to-warn-the-FDA claim.” Id. The court even suggested that, to survive dismissal, plaintiff would need to plausibly show that, had the defendant timely reported the events, “the FDA would have required some enhancement to the . . . warning already in place, which would have caused [plaintiff] to forego the [device] procedure.” Id.; see also, e.g., Johnson v. Hologic, Inc., No. 2:14-cv-0794-JAM-KJN-PS, 2015 WL 75240, at *4 (E.D. Cal. Jan. 6, 2015) (“[P]laintiff does not plead facts sufficient to show the existence of a causal connection between defendant’s lleged failure to report in conformance with FDA regulations and plaintiff’s injuries.”); Martin v. Medtronic, Inc., 63 F. Supp. 3d 1050, 1057-58 (D. Ariz. 2014) (“Martin II”) (dismissing allegations that the manufacturer “failed to report adverse events to he FDA” thus causing Plaintiff’s surgeon to “rel[y] on the . . . inadequate warnings in deciding to use [the device],” because what was “missing from [plaintiff’s] adverse events claims [was] any connection between defendants’ alleged failure to report adverse vents and her surgery”); Martin I, 32 F. Supp. 3d at 1043 (“Here, ‘a causal connection between [plaintiffs’] injuries and the alleged failure to report is absent. Plaintiff[s] generally allege[ ] that Defendants failed to report adverse events to the FDA. [They] also generally allege[ ] that these failures caused or contributed to [their] injuries. What is not alleged is any factual content that would support the causal nexus.’”) (quoting Hawkins v. Medtronic, Inc., No. 1:13-CV- 00499 AWI SKO, 2014 WL 346622, at *8 (E.D. Cal. Jan. 30, 2014), and citing Beavers- Gabriel, 15 F. Supp. 3d at 1040); Simmons v. Bos. Sci. Corp., No. CV 12-7962 PA (FFMx), 2013 WL 1207421, at *5 (C.D. Cal. Mar. 25, 2013) (dismissing where complaint “merely baldly assert[ed] that Defendants failed to report adverse events,” without alleging supporting facts or a causal link to the plaintiff’s injury). Plaintiff’s sole new allegation regarding reporting to the FDA alleges that, “[h]ad Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 14 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 9 EAST\144933839.1 Medtronic truthfully and timely communicated information to the FDA related to Mr. Perez’[s] . . . pump . . . , the defective pump would have be n replaced immediately and Mr. Perez would not have perished.” (FAC ¶ 175) (emphasis added). This is implausible. In Stengel, the Ninth Circuit held that plaintiffs stated a prallel claim because they alleged that, before Mr. Stengel’s injury, Medtronic had failed to report adverse events concerning other individuals to the FDA. 704 F.3d at 1227. The logic underlying Stengel’s causation analysis was that, if a defendant reports previous adverse events to the FDA, it is possible doctors who were not previously aware of those adverse events might conceivably become aware of them and, on that basis, change their treatment decisions for future patients. Even accepting this logic, the problem with Plaintiff’s new allegation is obvious—her other allegations admit (as they must) that Mr. Perez and his physicians were already aware of Mr. Perez’s own experiences with his pump for the obvious reason that they experienced them firsthand. Therefore, even if Medtronic did not report “information to the FDA related to Mr. Perez’[s] . . . pump” (FAC ¶ 175), that could not possibly have caused Mr. Perez’s death because he and his physicians were obviously already aware of the information. Last, even if Plaintiff’s purported failure to warn claim based on allegations regarding Medtronic’s alleged interactions with Mr. Perez’s physicians were not expressly preempted, it too would be inadequately pl aded because the allegations fail to make causation plausible.5 Plaintiff alleges Medtronic did not inform Mr. Perez’s 5 Plaintiff added allegations to the FAC alleging both that Medtronic did not inform Mr. Perez’s physicians of the March 2014 recall and that Medtronic made affirmative misrepresentations to Plaintiff’s physicians. (See, e.g., FAC ¶¶ 47-48, 172-74.) To the extent either of these allegations could support a par llel claim, it would still fail because the allegations do not adequately plead causation for the reasons explained in this section. Further, the Court should ignore the misrepresentation allegations because Plaintiff affirmatively dropped all of her fraud and misrepresentation claims from the FAC. And, even if considered, the misrepresentation allegations fail to meet the heightened pleading standard under Federal Rule of Civil Procedure 9(b), as they do not “state the time, place, and specific content of the false representations as well as the identities of the parties to the misrepresentation.” Edwards v. Marin Park, Inc., 356 F.3d 1058, 1066 (9th Cir. Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 15 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 10 EAST\144933839.1 physicians about overinfusion issues of which Medtronic was allegedly aware and, although Mr. Perez’s physicians nevertheless decided to replace the pump, Mr. Perez died before his workers’ compensation carrier approved the replacement. (Id. at ¶ 174.) Even if these allegations were true, the FAC lacks “ lear factual allegations establishing causation . . . .” (Or. [Doc. 25] at 9.) To establish causation, Plaintiff would have to plead facts making it plausible— not merely possible—that, had Medtronic provided different information to Mr. Perez’s physicians, (1) they would have drawn some new conclusion about Mr. Perez’s device (even though they had allegedly already decided to replace the pump); (2) they would have communicated the specific new issue to Mr. Perez’s workers’ compensation carrier; (3) the carrier would have agreed, on that basis, that there was a problem with Mr. Perez’s particular pump; (4) the carrier would have decided, on that basis, to accelerate its handling of Mr. Perez’s claim for a new pump; and (5) Mr. Perez would have actually received a new pump before he died. While Plaintiff alleges that Mr. Perez would have somehow “avoided use” of the pump or the pump would have been “replaced immediatly” (FAC ¶¶ 175-76), these conclusory statements are Plaintiff’s only effort t allege causation and fall far short of plausibly establishing any of the necessary links i the causal chain described above. This is especially true given that Plaintiff admits that Mr. Perez’s physicians were already “actively investigating” his pump, decided months before Mr. Perez’s death “that a new SynchroMed® II Device was necessary,” and had already made a request to the workers’ compensation carrier. (Id. at ¶¶ 45, 173.) For all of these reasons, Plaintiff has failed to assert a failure-to-warn claim that survives preemption, and the Court should dismiss thi claim with prejudice. 2004) (quotations and citations omitted). Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 16 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 11 EAST\144933839.1 B. Plaintiff’s Manufacturing Defect and Negligence Claims Are Impliedly Preempted and Inadequately Pleaded. Although the Court’s prior Order held that Plaintiff’s manufacturing defect and negligence claims (Counts I and III) were not expressly preempted, it did not decide whether these claims were impliedly preempted or inadequately pleaded. (Or. [Doc. 25] at 6-7, 7 n.3.) The Court should now dismiss these claims in their entirety on both of these grounds. 1. Plaintiff’s manufacturing defect and negligence claims are impliedly preempted. Only the federal government may enforce the FDCA and regulations promulgated thereunder, and as a result, any claims relying on these sources of law “‘[a]s a critical element’” are barred under § 337(a). Marsh v. Genentech, Inc., 693 F.3d 546, 553 (6th Cir. 2012) (quoting Buckman, 531 U.S. at 353).6 That the claim may be styled under state law is immaterial: “a private litigant cannot bring a state-law claim against a defendant when the state-law claim is in substance (even if not in form) a claim for violating the FDCA.” Leonard v. Medtronic, Inc., No. 1:10-CV-03787-JEC, 2011 WL 3652311, at *7 (N.D. Ga. Aug. 19, 2011) (quotation omitted). “Plaintiff[ ] cannot make an end run around [§ 337(a)] by recasting violations of the FDCA as violations of state common law.” In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147, 1161 (D. Minn. 2009), aff’d sub nom. Bryant v. Medtronic, Inc., 623 F.3d 1200 (8th Cir. 2010); accord Perez v. Nidek Co., 657 F. Supp. 2d 1156, 1166 (S.D. Cal. 2009) (plaintiffs cannot “privately enforce the FDCA and its regulations under the guise of state law claims”), aff’d, 711 F.3d 1109 (9th Cir. 2013). When a plaintiff alleges that a defendant’s conduct violated a federal requirement, 6 The mere fact that a claim might avoid express preemption under § 360k(a) has no bearing on whether the claim also escapes implied pr emption, because “neither an express pre-emption provision nor a saving clause ‘bar[s] the ordinary working of conflict pre-emption principles.’” Buckman, 531 U.S. at 352 (quoting Geier v. Am. Honda Motor Co., 529 U.S. 861, 869 (2000)). Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 17 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 12 EAST\144933839.1 but “merely mentions [state] law without specificity and alleges in conclusory fashion and without explanation that defendants ‘violated parallel state law,’” such claims “are impliedly preempted because they entirely rest on defendants’ purported violations of the [federal requirements], rather than on a state law c use of action that could exist independently of any federal requirements.” Martin v. Medtronic, Inc., No. 1:15-CV- 00994-DAD-MJS, 2017 WL 825410, at *7 (E.D. Cal. Feb. 24, 2017) (citing Perez, 711 F.3d at 1118); see also Frere v. Medtronic, Inc., No. EDCV 15-02338-BRO (DTBx), 2016 WL 1533524, at *7 (C.D. Cal. Apr. 6, 2016) (dism ssing manufacturing defect claim as impliedly preempted “because Plaintiff’s entire claim rests on conduct Plaintiff claim[s] . . . violated the FDA’s CGMPs”); Thibodeau v. Cochlear Ltd., No. CV-13- 02184-PHX-DGC, 2014 WL 3700868, at *5 (D. Ariz. July 25, 2014) (citing Perez, 711 F.3d at 1120) (negligence and manufacturing defect claims based on CGMP or federal regulation violations is “impliedly preempted because it is based directly on a violation of federal law”); Yosowitz v. Covidien LP, 182 F. Supp. 3d 683, 698 (S.D. Tex. 2016) (CGMP-based manufacturing defect claim is “impliedly preempted by § 337(a)”). The Court dismissed Plaintiff’s negligence per se claim in part because Plaintiff “appear[ed] to be asserting this claim ‘because the conduct violates the FDCA’ without an underlying state tort theory.” (Or. [Doc. 25] at 9 (quoting Perez, 711 F.3d at 1120).) Plaintiff’s manufacturing defect and negligence claims should be dismissed for the same reason. Plaintiff merely asserts that “[t]he SynchroMed® II Device implanted in Mr. Perez’s abdomen was manufactured in violation of Arizona and Minnesota law that parallels federal requirements set forth herein.” (FAC ¶ 141; see also id. at ¶ 182.) The FAC is devoid of allegations establishing how Medtronic’s alleged actions give rise to a state law cause of action that could exist independently of any federal requirements. Rather, the FAC alleges Plaintiff’s purported state l w causes of action exist because Medtronic’s conduct allegedly violated federal law. In her manufacturing defect claim, Plaintiff alleges the device “was unreasonably dangerous due to Medtronic’s violations of the Federal Food, Drug, and Cosmetic Act, the Medical Device Amendments, and the Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 18 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 13 EAST\144933839.1 regulations promulgated pursuant to these laws . . . .” (Id. at ¶ 143 (emphasis added); see also id. at ¶ 148 (“Defendants breached their duty under Arizona and Minnesota law in that they failed use reasonable care to ensure that Mr. Perez’s SynchroMed® II Device complied with federal requirements . . . .”).) Therefore, Plaintiff’s manufacturing defect and negligence claims are impliedly preempted, and the Court should dismiss them in their entirety. 2. Plaintiff’s manufacturing defect and negligence claims are inadequately pleaded. To state a claim that survives express preemption under 21 U.S.C. § 360k(a), Plaintiff “must allege,” among other things, that a “federal violation caused [Mr. Perez’s] injuries.” Millman, 2015 WL 778779, at *4 n.2; accord, e.g., Martin I, 32 F. Supp. 3d at 1033-34 (“To properly plead parallel claims that survive preemption, a plaintiff must allege facts (1) showing an alleged violation of FDA regulations or requirements related to [the device], and (2) establishing a causal nexus between the alleged injury and the violation.”) (internal quotation marks omitted); Erickson, 846 F. Supp. 2d at 1092 (same). The FAC, which did not supplement the manufacturing defect and negligence claims, is devoid of factual allegations making it plausible that Medtronic’s alleged violations of federal regulations actually affected Mr. Perez’s device and proximately caused his death. Absent such allegations, the Court cannot “infer more than the mere possibility of misconduct.” Iqbal, 556 U.S. at 679. Conclusory causation allegations and legal conclusions do not suffice. See Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 1301 (D. Colo. 2008) (“The complaint does allege generally that the [device] was unreasonably dangerous and defective . . . , which proximately caused plaintiff’s injuries. However, such conclusory allegations standing alone are not sufficient to sustain plaintiff’s burden of pleading under Twombly.”). Federal courts applying Twombly— and state courts applying less demanding pleading standards—have consistently dismissed claims rising from allegedly defective SynchroMed II devices virtually identical to Plaintiff’s where, as here, the complaint “did Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 19 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 14 EAST\144933839.1 not allege . . . sufficient facts to show a causal connection between a specific CGMP violation and the alleged malfunction of the specific Device implanted in Plaintiff’s body that allegedly caused Plaintiff’s injury.” Lutz-Cummings v. Medtronic, Inc., No. 27-CV- 15-16417, 2016 WL 3082314, at *5 (Minn. Dist. Ct. May 31, 2016); accord, e.g., Frere, 2016 WL 1533524, at *6 (dismissing claims where complaint did not “allege any facts to suggest how Defendants’ manufacturing defect . . . caused her injuries”). Plaintiff’s failure to allege facts plausibly suggesting a causal connection between any alleged regulatory violation, a particular defect in the specific device implanted in Mr. Perez, and Mr. Perez’s injury requires dismissal. See, e.g., Herrnandez v. Stryker Corp., No. C14-0613RSM, 2014 WL 7044171, at *6 (W.D. Wash. Dec. 11, 2014) (dismissing manufacturing-defect claim where plaintiff “failed to connect a violation of the CGMPs . . . or explain how such violations caused [the alleged] injury”); Franzese v. St. Jude Med., Inc., No. 13-CV-3203 JS WDW, 2014 WL 2863087, at *5 (E.D.N.Y. June 23, 2014) (dismissing manufacturing-defect claim where “Plaintiffs have not sufficiently alleged how this [federal] violation caused Plaintiffs’ injuries”); see also De La Paz, 159 F. Supp. 3d at 1095 (plaintiff’s “failure to allege a causal link between any adulteration of [her] device and her injuries is fatal to her manufacturing-defect claims”). V. CONCLUSION For the foregoing reasons, Medtronic respectfully requests that the Court grant this Motion, dismiss all of Plaintiff’s causes of action against Medtronic with prejudice and without leave to amend, and award Medtronic its osts and such other relief as the Court may deem appropriate. /// /// /// Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 20 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 15 EAST\144933839.1 Dated: July 5, 2017 Respectfully submitted, DLA PIPER LLP (US) By: /s/ Cole J. Schlabach_________________ MARK A. NADEAU, Bar No. 011280 mark.nadeau@dlapiper.com COLE J. SCHLABACH, Bar No. 026364 cole.schlabach@dlapiper.com 2525 East Camelback Road, Suite1000 Phoenix, AZ 85016-4232 Tel: 480.606.5100 Fax: 480.606.5101 Keiko L. Sugisaka (MN #0266152) (pro hac vice pending) keiko.sugisaka@maslon.com MASLON LLP 3300 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402-4140 Tel: 612.672.8200 Fax: 612.672.8397 ATTORNEYS FOR DEFENDANTS Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 21 of 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 16 EAST\144933839.1 CERTIFICATE OF SERVICE I hereby certify that on July 5, 2017, I electronically transmitted the attached document to the Clerk’s Office, using the CM/ECF System for filing and transmitted the same to the following CM/ECF registrants: Paul L. Stoller (AZ Bar #016773) paul.stoller @gknet.com Lincoln Combs (AZ Bar #025080) lincoln.combs@gknet.com GALLAGHER & KENNEDY 2575 East Camelback Road, Suite 1100 Phoenix, Arizona 85016-9225 Telephone: (602) 530-8000 Gale D. Pearson (MN #244673) gpearson@prslegal.com PEARSON, RANDALL & SCHUMACHER, P.A. 310 Fourth Avenue South, Suite 5010 Minneapolis, Minnesota 55415 Telephone: (612) 767-7500 /s/ April Natzke Case 2:16-cv-02896-ROS Document 32 Filed 07/05/17 Page 22 of 22