Peter Paturzo et al v. Boston Scientific Corporation et al

NOTICE OF MOTION AND MOTION to Dismiss Case

C.D. Cal.June 2, 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESX) 410223 v4 Eva M. Weiler (SBN: 233942) eweiler@shb.com Brian P. Ziska (SBN: 272043) bziska@shb.com SHOOK, HARDY & BACON L.L.P. Jamboree Center 5 Park Plaza, Suite 1600 Irvine, California 92614-2546 Telephone:949-475-1500 Facsimile:949-475-0016 Attorneys for Defendants Boston Scientific Corporation and Guidant LLC UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA PETER PATURZO; NAN PATURZO, Plaintiffs, vs. BOSTON SCIENTIFIC CORPORATION; GUIDANT LLC, formerly known as GUIDANT CORPORATION; GUIDANT SALES LLC, formerly known as GUIDANT SALES CORPORATION; and DOES 1 through 50, inclusive, Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case No. 8:16-cv-2174 JLS (KESx) DEFENDANTS BOSTON SCIENTIFIC CORPORATION’S AND GUIDANT LLC’S NOTICE OF MOTION AND MOTION TO DISMISS SECOND AMENDED COMPLAINT Date: July 28, 2017 Time: 2:30 p.m. Dept.: 10A [Filed concurrently with Declaration of Brian Ziska; Request for Judicial Notice] Complaint Filed: August 16, 2016 First Am. Compl. Filed: February 13, 2017 Second Am. Compl. Filed: May 12, 2017 TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on July 28, 2017, at 2:30 p.m., or as soon thereafter as this matter may be heard, in Courtroom 10A, 10th Floor of the Ronald Reagan Federal Building and United States Courthouse, 411 W. Fourth St., Santa Ana, CA, 92701, defendants Boston Scientific Corporation and Guidant LLC (collectively “Boston Scientific” or “defendants”) will move the Court for an order Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 1 of 33 Page ID #:542 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-cv-2174 JLS (KESx) 410223 v4 dismissing the complaint, and each cause of action alleged therein, filed by plaintiffs Peter Paturzo and Nan Paturzo. This motion is made pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure, and is based on the following grounds: 1. Plaintiffs’ state law claims are preempted by federal law because the medical device at issue in this action, a TELIGEN Model E102 implantable cardioverter defibrillator (“ICD”), serial number 249953, is a Class III Medical Device that was evaluated under the FDA’s premarket approval process. 1 Plaintiffs also fail to plead any non-preempted parallel claims regarding the Model E102 ICD. 2. Plaintiffs’ claims are barred by the statute of limitations. Cal. Civ. Proc. Code § 335.1. 3. The complaint fails to state a claim for breach of implied warranty because plaintiffs have not identified who made representations, any particular actionable representations, or the context in which such representations were made. 4. The loss of consortium claim fails as it is wholly derivative of the other claims, so the loss of consortium claim also fails. This motion is made following meet and confer attempts with counsel pursuant to Local Rule 7-3, as set forth in the Declaration of Brian P. Ziska, filed concurrently with this motion. / / / / / / / / / / / / / / / / / / 1 Mr. Paturzo was allegedly implanted with three Boston Scientific ICDs. Each ICD was approved through the FDA’s premarket approval process, so all claims are preempted. Plaintiffs, however, define the “Subject ICD” as only the Model E102. Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 2 of 33 Page ID #:543 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-cv-2174 JLS (KESx) 410223 v4 This motion is based on this Notice of Motion, the attached Memorandum of Points and Authorities in support thereof, the Declaration of Brian P. Ziska and Request for Judicial Notice filed concurrently herewith, the pleading and documents on file in this case, and such other evidence as may be presented at the hearing on this motion. Dated: June 2, 2017 Respectfully Submitted, SHOOK, HARDY & BACON L.L.P. By: /s/ Brian P. Ziska Brian P. Ziska Attorneys for Defendants Boston Scientific Corporation and Guidant LLC Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 3 of 33 Page ID #:544 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-cv-2174 JLS (KESx) 410223 v4 TABLE OF CONTENTS Page I. INTRODUCTION ................................................................................................ 1 II. LEGAL STANDARD .......................................................................................... 2 III. UNDER RIEGEL, FEDERAL LAW PREEMPTS PLAINTIFFS’ CLAIMS ..... 3 A. The Device At Issue Was Approved Through The Pre-Market Approval Process ....................................................................................... 3 B. Federal Law Expressly Preempts State-Law Claims Concerning Class III Devices Approved Through The Process .................................... 4 C. Plaintiffs Have Not Alleged Any Parallel Claims Related to The TELIGEN Model E102 ICD at Issue ......................................................... 8 1. The Products Liability - Manufacturing Defect Claim Is Preempted Because There Is No Allegation of Any Particular Defect, Or That Such Defect Violates an FDA Requirement ......... 9 2. The Products Liability - Failure to Warn Claim Is Preempted Because No Viable Parallel Claims Are Alleged .......................... 12 3. Breach of Implied Warranty And Negligence Claims Are Preempted Because No Viable Parallel Claims Are Alleged ........ 17 IV. PLAINTIFFS’ CLAIMS ARE BARRED BY THE STATUTE OF LIMITATIONS .................................................................................................. 17 V. PLAINTIFFS’ CLAIMS FAIL ON ADDITIONAL GROUNDS ..................... 20 A. Plaintiffs’ Breach of Implied Warranties Claim Fails As A Matter Of California Law......................................................................... 20 B. The Loss Of Consortium Claim Is Derivative Of The Other Claims So It Fails For The Same Reasons ............................................... 22 VI. CONCLUSION .................................................................................................. 22 Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 4 of 33 Page ID #:545 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-cv-2174 JLS (KESx) 410223 v4 TABLE OF AUTHORITIES Page(s) CASES Ashcroft v. Iqbal, 556 U.S. 662, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009) .................................. 2, 16 Bell Atl. Corp. v. Twombly, 550 U.S. 544, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007) .............................. 2, 3, 16 Bentzley v. Medtronic, Inc., 827 F. Supp. 2d 443 (E.D. Pa. Nov. 29, 2011) .................................................. 12, 13 Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039, 70 Cal. Rptr. 3d 566 (2008) ....................................... 10, 20 Brown v. Superior Court, 44 Cal. 3d 1049 (1988) ...................................................................................... 15, 20 Buckland v. Threshold Enters., Ltd., 155 Cal. App. 4th 798 (2008) .................................................................................. 20 Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S. 341, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2008) ................................... 6, 7 Carlin v. Superior Court, 13 Cal. 4th 1104 (1996) ........................................................................................... 15 Cohen v. Guidant Corp., No. CV-05-8070-R, 2011 WL 637472 (C.D. Cal. Feb. 15, 2011) ........................ 5, 8 Coleman v. Boston Scientific Corp., No. 1:10-CV-01968-OWW, 2011 WL 3813173 (E.D. Cal. Aug. 29, 2011) ........................................................................................................................ 19 Cornwell v. Stryker Corp., No. 1:10-cv-00066-EJL, 2010 WL 4641112 (D. Idaho Nov. 1, 2010) ..................... 6 Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085 (C.D. Cal. 2011) ........................................................... 5, 7, 10 Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 5 of 33 Page ID #:546 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 vi DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 Fox v. Ethicon Endo-Surgery, Inc., 35 Cal. 4th 797 (2005) ....................................................................................... 18, 19 Funke v. Sorin Group USA, Inc., 147 F. Supp. 3d 1017 (C.D. Cal. 2015) ................................................................... 14 Gates v. Medtronic, Inc., 192 F. Supp. 3d 704 (W.D. Tex. 2016) ................................................................... 15 Gillman v. Boston Scientific Corp., No. 11-3067-CL, 2012 WL 892239 (D. Or. Jan. 27, 2012) ...................................... 6 Grant v. Corin Group PLC, No. 15cv169-CAB-BLM, 2016 WL 4447523 (S.D. Cal. Jan. 15, 2016) ................ 12 Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012) ............................................................... 11, 13 Hawkins v. Medtronic, Inc., No. 1:13-cv-00499 AWI SKO, 2014 WL 346622 (E.D. Cal. Jan. 30, 2014) ........................................................................................................................ 14 Henderson v. Pfizer, Inc., 285 F. App’x. 370 (9th Cir.2008) ............................................................................ 19 Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004) ...................................................................................... 8 Houston v. Medtronic, 957 F. Supp. 2d 1166 (C.D. Cal. 2013) ................................................................... 12 In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147 (D. Minn. 2009) ............................................................... 6, 10 In re Medtronic, Inc., Sprint Fidelis Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) ................................................................................... 7 Jolly v. Eli Lilly & Co., 44 Cal. 3d 1103 (1988) ............................................................................................ 18 Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC(RNBx), 2013 WL 6177032 (C.D. Cal. Nov. 22, 2013) ........................................................................................................... 5 Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 6 of 33 Page ID #:547 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 vii DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC(RNBx), 2014 WL 819392 (C.D. Cal. Feb. 14, 2014) .................................................................................................................... 5 Kennedy v. Medtronic, Inc., 366 Ill. App. 3d 298 (2006) ..................................................................................... 15 Knoppel v. St. Jude Medical, Inc., No. SACV 13-383 JVS (ANx), 2013 WL 3803612 (C.D. Cal. May 7, 2013) .......................................................................................................................... 5 Leong v. Square Enix of Am. Holdings, Inc., No. CV 09-4484 PSG, 2010 WL 1641364 (C.D. Cal. Apr. 20, 2010).................... 20 Lowe v. Medtronic, Inc., No. CV-11-9551-R, 2012 WL 3656468 (C.D. Cal. May 9, 2012) ............. 3, 5, 8, 10 Malonzo v. Mentor Worldwide, LLC, No. C 14-01144 JSW, 2014 WL 2212235 (N.D. Cal. May 28, 2014) ..................... 8 McGuan v. Endovascular Techs., Inc., 182 Cal. App. 4th 974, 106 Cal. Rptr. 3d 277 (2010) .............................................. 5 Medtronic v. Lohr, 518 U.S. 470 (1996)................................................................................................... 8 Mills v. Forestex Co., 108 Cal. App. 4th 625 (2003) .................................................................................. 18 Norgart v. Upjohn Co., 21 Cal. 4th 383 (1999) ....................................................................................... 17, 18 Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013) ............................................................................... 6, 7 Plenger v. Alza Corp., 11 Cal. App. 4th 349 (1992) .................................................................................... 15 Plumlee v. Pfizer, Inc., 664 F. App’x. 651 (9th Cir. Nov. 9, 2016) .............................................................. 18 Rhynes v. Stryker Corp., No. 10-5619 SC, 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011) ........................... 5, 6 Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 7 of 33 Page ID #:548 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 viii DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006) ...................................................................................... 3 Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).......................................................................................... passim Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minn. 2009) ............................................................... 11, 13 RxUSA Wholesale, Inc. v. Alcon Labs., Inc., 661 F. Supp. 2d 218 (E.D.N.Y 2009) ...................................................................... 16 Sherman v. Stryker Corp., No. SACV 09-224, 2009 WL 2241664 (C.D. Cal. Mar. 30, 2009) ........................ 20 Simmons v. Boston Scientific Corp., No. 12-7962, 2013 WL 1207421 (C.D. Cal. Mar. 25, 2013) ........................ 5, 10, 14 Smith v. St. Jude Medical, Inc., 217 Cal. App. 4th 313 (2013) .................................................................................. 15 Sprewell v. Golden State Warriors, 266 F.3d 979 (9th Cir. 2001) ................................................................................... 21 Valentine v. Baxter Healthcare Corp., 68 Cal. App. 4th 1467 (1999) ............................................................................ 15, 20 Weaver v. Ethicon Inc., No. 16vc257-GPC(BGS), 2017 WL 680725 (S.D. Cal. Feb. 21, 2017) .......... passim Wright v. Gen. Motors Acceptance Corp., No. 09CV2666 JM(AJB), 2012 WL 253157 (S.D. Cal. Jan. 25, 2012) ................. 20 STATUTES 21 U.S.C. § 337 ............................................................................................................... 6 21 U.S.C. § 360 ...................................................................................................... passim Cal. Code Civ. Proc. § 335.1 ........................................................................................ 17 Cal. U. Com. Code § 2314(2)(f) ................................................................................... 21 Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 8 of 33 Page ID #:549 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 ix DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 OTHER AUTHORITIES 21 C.F.R. § 7.3 .............................................................................................................. 16 21 C.F.R. § 7.49 ...................................................................................................... 14, 15 21 C.F.R. §7.50 ............................................................................................................. 14 21 C.F.R. § 803.50 ........................................................................................................ 13 Fed. R. Civ. P. 8 ............................................................................................................... 2 Fed. R. Civ. P. 12 ......................................................................................................... 2, 3 Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 9 of 33 Page ID #:550 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 I. INTRODUCTION This Court’s prior order dismissing the first amended complaint should be affirmed again. Plaintiffs’ mere addition of vague and ambiguous conclusions does not constitute facts sufficient for a parallel claim, and the second amended complaint still cannot survive preemption. Plaintiffs Peter Paturzo and Nan Paturzo (“plaintiffs”) claim personal injuries after Peter Paturzo had a TELIGEN Model E102 implantable cardioverter defibrillator (“ICD”), serial number 249953 (“Model E102” or “device at issue”) implanted on or about January 29, 2010. (Second Amended Complaint (“SAC”) ¶ 10.) The crux of plaintiffs’ claim is that there was a defect in the device that caused “premature battery depletion.” (See, e.g., SAC ¶¶ 10, 12.) Plaintiffs allege causes of action for: (1) products liability for manufacturing defect; (2) products liability failure to warn; (3) breach of implied warranties; (4) negligence; and (5) loss of consortium. Following the Court’s order dismissing the first amended complaint based on preemption (among other grounds), plaintiffs added vague conclusions of wrongdoing. (See, e.g., SAC ¶¶ 13-15, 33-37, 44-48, 60, 67-68, 76.) These allegations are so vague that it is difficult to discern precisely what parallel claims they might be trying to assert. For example, plaintiffs added vague allegations of wrongdoing regarding a product recall (SAC ¶¶ 13, 15) and other civil/criminal cases (SAC ¶¶ 14, 47), but still fail to cite any facts supporting particular violations of federal requirements specific to the device that parallel plaintiffs’ state law claims. The vast majority of the additions to the second amended complaint are merely repackaging prior allegations the Court already found preempted, such as general conclusory allegations regarding unidentified defects (see SAC ¶¶ 33-37), and that Boston Scientific was somehow monitoring the device at issue (see SAC ¶¶ 44-45, 48). Despite their third opportunity to do so, there are still no particular facts alleged to support any requirements specifically relating to the Model E102, let alone that any Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 10 of 33 Page ID #:551 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 such violations caused the “premature battery depletion” allegedly at issue in plaintiffs’ device. Plaintiffs have not-and cannot-allege specific facts for any claims to escape preemption. The Court should grant the motion to dismiss, without leave to amend. Plaintiffs’ claims are also barred by the statute of limitations because plaintiffs knew or should have known of the alleged battery depletion issues when the first ICD was replaced with the Model E102 in January 2010. And plaintiffs’ were at least on notice no later than August 13, 2013, when Boston Scientific issued a voluntary product advisory concerning a low voltage capacitor that may be compromised over time, causing increased current drain that can lead to premature battery depletion. Plaintiffs’ claims fail on additional grounds. The implied warranty claim fails due to lack of privity and because plaintiffs have not identified who made representations, any particular actionable representations, or the context in which such representations were made. Finally, the loss of consortium claim is derivative of the other causes of action so it fails for the same reasons. II. LEGAL STANDARD A complaint that fails “to state a claim upon which relief can be granted” should be dismissed. Fed. R. Civ. P. 12(b)(6). To “state a claim,” a complaint must include “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a). Rule 8(a) “requires a ‘showing,’ rather than a blanket assertion, of entitlement to relief.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 n.3, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007). To survive a motion to dismiss for failure to state a claim, a complaint must contain “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570. A complaint meets this standard only if it “pleads factual content 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, 678, 129 S. Ct. 1937, 173 Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 11 of 33 Page ID #:552 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 L. Ed. 2d 868 (2009). “Factual allegations must be enough to raise a right to relief above the speculative level, . . . on the assumption that all the allegations in the complaint are true (even if doubtful in fact).” Twombly, 550 U.S. at 555 (citations omitted). Federal preemption under the Medical Device Amendments is a question of law for the court to decide and, therefore, can be resolved through a motion to dismiss under Fed. R. Civ. P. 12(b)(6). See, e.g., Riegel v. Medtronic, Inc., 451 F.3d 104, 107 (2d Cir. 2006), aff’d, 552 U.S. 312 (2008); Lowe v. Medtronic, Inc., No. CV-11-9551-R, 2012 WL 3656468 (C.D. Cal. May 9, 2012). III. UNDER RIEGEL, FEDERAL LAW PREEMPTS PLAINTIFFS’ CLAIMS. The Court’s prior order succinctly set forth the express preemption provision of the Medical Device Amendments of 1976, 21 U.S.C. § 360 (“MDA”), as interpreted by the United States Supreme Court in Riegel and its progeny. (Dkt. No. 26, at pp. 4- 6.) The framework will, therefore, not be reiterated at length again here, but Boston Scientific provides a brief background on why preemption applies in Sections III.A and III.B below. The crux of the preemption dispute is whether plaintiffs’ additional allegations in the second amended complaint are sufficient to allege a parallel claim, and these additional allegations are addressed in Sections III.C.1-III.C.3, beginning below on page 9. A. The Device At Issue Was Approved Through The Pre-Market Approval Process. As the Court found in the prior motion to dismiss, there is no dispute that the TELIGEN Model E102 ICD at issue is subject to FDA requirements. (Dkt. No. 26, at p. 5.) Class III medical devices, such as the TELIGEN Model E102 ICD at issue in Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 12 of 33 Page ID #:553 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 this case, are subject to an intensive FDA approval process-the Pre-Market Approval (“PMA”) process. It is a matter of public record that the FDA approved the TELIGEN Model E102 ICD through the PMA process. (See Request for Judicial Notice (“RJN”), Ex. A [63 Fed. Reg. 3905 (Jan. 27, 1998) (listing the original July 18, 1997 PMA approval for the VENTAK AV AICD System, PMA No. P960040)]; see also RJN, Ex. B [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm? id=P960040 (last updated May 29, 2017) (listing links to the original approval letter and all applicable supplements, including Supplement No. S155 [RJN, Ex. C, available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960040S155, which lists the May 8, 2008 supplemental PMA approval for the TELIGEN Model E102 at issue].) The original and supplemental PMA approvals remain in effect and have never been suspended or revoked. In fact, the applicable statutes and regulations specifically require action and hearings by the FDA before a Class III medical device’s PMA approval may be suspended or revoked. See 21 U.S.C. §§ 360e(e)(1). B. Federal Law Expressly Preempts State-Law Claims Concerning Class III Devices Approved Through The Process. There is no dispute that the first condition for preemption is met because the PMA process imposes device-specific federal requirements, as set forth above. The focus for this motion is, therefore, on the second condition-whether plaintiffs’ state law claims would establish “any requirement relating to safety or effectiveness that is different from, or in addition to, federal requirements.” Riegel, 552 U.S. at 328 (emphasis added, citation and quotation admitted). Like the Supreme Court in Riegel, state and federal courts in California have recognized that federal law broadly preempts all manner of state-law claims at the pleading stage against Class III medical devices approved through the FDA’s PMA Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 13 of 33 Page ID #:554 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 process, including several decisions in this District involving similar devices. See, e.g., Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC(RNBx), 2013 WL 6177032 (C.D. Cal. Nov. 22, 2013) (motion to dismiss granted against all claims involving a bone growth stimulator) (Kashani I) (Carney, J.); Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC(RNBx), 2014 WL 819392 (C.D. Cal. Feb. 14, 2014) (motion to dismiss all claims in amended complaint granted in action involving bone growth device) (Kashani II) (Carney, J.); Knoppel v. St. Jude Medical, Inc., No. SACV 13-383 JVS (ANx), 2013 WL 3803612 (C.D. Cal. May 7, 2013) (motion to dismiss granted against all claims in case involving cardiac defibrillator) (Selna, J.); Simmons v. Boston Scientific Corp., No. 12-7962, 2013 WL 1207421 (C.D. Cal. Mar. 25, 2013) (granting motion to dismiss all claims in case involving implantable cardiac defibrillator) (Anderson, J.); Lowe v. Medtronic, Inc., No. CV-11- 9551-R, 2012 WL 3656468 (C.D. Cal. May 9, 2012) (Real, J.) (granting preemption- based motion to dismiss all claims asserted against implantable cardiac defibrillator manufacturer); Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085 (C.D. Cal. 2011) (Guilford, J.) (granting preemption-based motion for judgment on the pleadings as to all claims asserted against pacemaker manufacturer); Rhynes v. Stryker Corp., No. 10-5619 SC, 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011) (granting preemption- based motion to dismiss all claims, including claim for violation of California’s Unfair Competition Law); Cohen v. Guidant Corp., No. CV-05-8070-R, 2011 WL 637472 (C.D. Cal. Feb. 15, 2011) (Real, J.) (granting preemption-based motion to dismiss all claims asserted against pacemaker manufacturer); see also McGuan v. Endovascular Techs., Inc., 182 Cal. App. 4th 974, 106 Cal. Rptr. 3d 277 (2010) (affirming grant of summary judgment in Johnson v. Endovascular Techs., Inc., No. 1-05-CV-037784, 2008 WL 3139424 (Cal. Super. May 19, 2008) and McGuan v. Endovascular Techs., Inc., No. 1-04-CV-025603, 2008 WL 3139418 (Cal. Super. May 19, 2008) against all claims in a case involving an endograft device), review denied (Cal. June 9, 2010)). Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 14 of 33 Page ID #:555 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 Since Riegel, “courts across the country have applied Section 360k (a) broadly, preempting all manner of claims from strict products liability and negligence, to breach of warranty, to failure to warn and manufacturing-and-design-defect, to negligence per se.” In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147, 1158 n.13 (D. Minn. 2009), aff’d, 623 F.3d 1200 (8th Cir. 2010); see also Rhynes, 2011 WL 5117168, at *4-5 & nn.5-6 (collecting cases). “[W]hen Sections 337(a) and 360k(a) - as construed in Buckman [Co. v. Plaintiff’s Legal Comm., 531 U.S. 341, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2008)] and Riegel, respectively - are read together, nearly all types of claims concerning FDA-approved medical devices are preempted.” In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d at 1161. Several federal district courts within the Ninth Circuit have also extended Riegel’s holding to preempt many of the same state-law claims brought by plaintiffs here. See, e.g., Gillman v. Boston Scientific Corp., No. 11-3067-CL, 2012 WL 892239 (D. Or. Jan. 27, 2012) (granting preemption-based motion to dismiss on all but one claim, which was dismissed on other grounds); Cornwell v. Stryker Corp., No. 1:10-cv-00066-EJL, 2010 WL 4641112 (D. Idaho Nov. 1, 2010) (granting preemption-based motion to dismiss all claims). The MDA also prohibits suits by private litigants to enforce the provisions of the Act. 21 U.S.C. § 337(a). The FDA is responsible for investigating and enforcing potential violations of the FDCA, as amended by the MDA. Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013). Because the statutory scheme amply empowers the FDA to punish and deter potential fraud, allegations such as “fraud-on-the-FDA” claims conflict with and are impliedly preempted by federal law. Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S. 341, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2008). Indeed, “when Sections 337(a) and 360k(a)-as construed in Buckman and Riegel, respectively-are read together, nearly all types of claims concerning FDA-approved medical devices are preempted, including plaintiffs’ failure-to-warn-claims here.” In Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 15 of 33 Page ID #:556 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d at 1157 (emphasis added). There is only a “narrow gap” through which a state-law claim must fit: “The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by §360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).” Perez, 711 F.3d at 1120 (citing In re Medtronic, Inc., Sprint Fidelis Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010)) (emphasis in both). As in Riegel, the Model E102 ICD at issue here was at all times approved as safe and effective by the FDA through the PMA process, which imposes specific federal requirements. See Riegel, 552 U.S. at 322-23. Plaintiffs’ state law claims against the Model E102 ICD are exactly the type of claims that are preempted under Riegel. (See generally SAC.) Nearly the same product liability allegations of premature battery depletion were found to be preempted by another court in this District. In Erickson, the plaintiff alleged that although he was told his pacemakers would last ten years, three of his devices failed in less than five years, and like here, plaintiffs’ asserted claims based on this alleged defect. Erickson, 846 F. Supp. 2d at 1088. The Honorable Andrew J. Guilford found that the MDA preempted all of plaintiff’s claims. Id. at 1090-94. Like Erickson, federal law preempts plaintiffs’ claims here because, if successful, plaintiffs’ claims would require a California jury to contradict the FDA’s decisions and find that the device at issue (1) was accompanied by inadequate warnings or labeling, (2) was defectively designed, and/or (3) was defectively manufactured. Such findings would require different or additional warnings or labeling, a different design, or a different manufacturing process than the ones expressly approved and required by the FDA. In effect, plaintiffs’ claims would encourage, and in fact require, “judges and juries to second-guess the balancing of benefits and risks of a specific device to their intended patient population - the central Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 16 of 33 Page ID #:557 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 role of FDA - sometimes on behalf of a single individual or group of individuals.” Horn v. Thoratec Corp., 376 F.3d 163, 178 (3d Cir. 2004) (quoting the FDA’s Amicus Curiae Letter Br. at 25-26). Accordingly, the MDA expressly preempts all of plaintiffs’ state-law claims. See Riegel, 552 U.S. at 329 (“Surely this means that the MDA would pre-empt a jury determination that the FDA-approved labeling for a pacemaker violated a state common-law requirement for additional warnings.”). C. Plaintiffs Have Not Alleged Any Parallel Claims Related to The TELIGEN Model E102 ICD at Issue. The decision in Riegel left open the possibility of a narrow, so-called “parallel claim” exception to express preemption under the MDA. The exception is based on the notion that “[the MDA] 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, 552 U.S. at 330 (quoting Lohr, 518 U.S. at 495). To fit a claim within this narrow exception, plaintiffs “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.” Lowe, 2012 WL 3656468, at *1 (citing Cohen v. Guidant Corp., No. CV-05-8070-R, 2011 WL 637472 (C.D. Cal. Feb. 15, 2011). To allege a parallel claim that survives preemption, plaintiffs must identify, with particularity, a pre-existing state cause of action that is “substantially identical” to a pre-existing federal requirement, both of which prohibit the same conduct. Malonzo v. Mentor Worldwide, LLC, No. C 14-01144 JSW, 2014 WL 2212235, at *3 (N.D. Cal. May 28, 2014) (“. . . Plaintiff must allege state-law requirements that are parallel to the federal requirements.”); see also Medtronic v. Lohr, 518 U.S. 470, 496- 97 (1996) (for a claim to be “parallel” under § 360k(a), the state and federal Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 17 of 33 Page ID #:558 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 requirements must be “substantially identical”). Plaintiffs have not satisfied these requirements. With the foregoing in mind, Boston Scientific will address each of plaintiffs’ claims in turn, consistent with the Court’s prior order. 1. The Products Liability - Manufacturing Defect Claim Is Preempted Because There Is No Allegation of Any Particular Defect, Or That Such Defect Violates an FDA Requirement. A manufacturing defect claim survives express preemption only if there are “specific allegations that the manufacturing of the device both fell short of the FDA's requirements for manufacturing and-based on the same deficiency-was defectively manufactured under California law.” Weaver v. Ethicon Inc., No. 16vc257- GPC(BGS), 2017 WL 680725, at *4 (S.D. Cal. Feb. 21, 2017). Here, the Court previously held that plaintiffs “fail to allege any facts relating the premature battery depletion to Defendants’ manufacturing processes, and, specifically, the FDA’s requirements for manufacturing.” (Dkt No. 26 at p. 8.) The second amended complaint fails to remedy any of the deficiencies of the manufacturing defect claim. Plaintiffs added only the paragraphs 13-15 and 33-37, which essentially cover three categories: (1) there was a recall (SAC ¶¶ 13, 15); (2) there were other civil and/or criminal cases that have been settled (SAC ¶ 14); and (3) the device was not reasonably safe and contained unidentified manufacturing defects (SAC ¶¶ 33-37). 2 First, plaintiffs have added assertions that the defective manufacturing involved a deficient capacitor that may cause premature battery depletion. (SAC ¶ 13.) Plaintiffs allege that there was a recall of the Subject ICD. (SAC ¶¶ 13, 15.) These 2 The remaining allegations were already found to be insufficient by the Court in its prior order granting defendants’ motion to dismiss the first amended complaint. (Dkt. No. 26.) The prior allegations fail for the reasons set forth in this order, so they will not be discussed again here. Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 18 of 33 Page ID #:559 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 new assertions remain deficient because there are still no facts regarding any particular deficiencies in Boston Scientific’s manufacturing processes, let alone that such deficiencies violated particular FDA requirements for manufacturing. And no reasonable inferences can be drawn based on such vague allegations. (Dkt. No. 26.) Furthermore, as set forth in Boston Scientific’s prior motion to dismiss, the mere existence of a product recall does not provide a factual basis upon which plaintiffs can establish a viable parallel claim. See Lowe, 2012 WL 3656468, at *1 (“Plaintiff’s allegations relating to a warning letter and a subsequent recall are not sufficient to establish a parallel claim.”) (citations omitted). Indeed, “courts have recognized that product recalls do not create a presumption that FDA requirements have been violated.” Simmons, 2013 WL 1207421, at *4 (citing, inter alia, Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039, 1056, 70 Cal. Rptr. 3d 566 (2008); Erickson, 846 F. Supp. 2d at 1093 (same)). And the existence of a product recall does not invalidate a device’s PMA approval. See Erickson, 846 F. Supp. 2d at 1093 (holding that a recall does not deprive the manufacturer of its preemption argument). To allow otherwise would improperly “result in retroactive second-guessing of the FDA’s decision-making” regarding whether a particular device was safe and effective for consumer use. In re Medtronic, Inc., Sprint Fidelis Prods. Liab. Litig., 592 F. Supp. 2d at 1155-56 (emphasis in original). On August 13, 2013, Boston Scientific issued a voluntary product advisory concerning a low voltage capacitor that may be compromised over time, causing increased current drain that can lead to premature battery depletion. See FDA, Class 2 Recall, Boston Scientific TELIGEN ICD, Recall Number Z-0026-2014, available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121616 (Oct. 17, 2013) (hereinafter “FDA Public Information on LV Capacitor Advisory”) (attached as Exhibit D to Request for Judicial Notice, filed concurrently herewith). Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 19 of 33 Page ID #:560 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 The FDA’s publicly-available and judicially noticeable website lists the FDA’s “Determined Cause” of the low voltage capacitor issue as a design issue-not a manufacturing issue. (RJN, Ex. D [FDA Public Information on LV Capacitor Advisory].) Plaintiffs admitted this in their first amended complaint. (Dkt. No. 20 [FAC ¶ 24].) Therefore, based on judicially noticeable documents and plaintiffs’ prior admission, the FDA-determined cause was a design defect, not a manufacturing defect. The FDA’s website on the advisory also states that, “[p]er FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.” (RJN, Ex. D, n.2.) Because the FDA terminated the advisory on April 10, 2014 (id. at 1), the FDA’s determination of the recall cause is final. Any claim based on an alleged design defect that led to this recall is preempted under Riegel and cannot be used to retroactively second-guess the FDA’s approval of the device. In addition, plaintiffs now further allege that the faulty capacitors “at least in part” (so not necessarily the Subject ICD) were supplied by outside suppliers and incorporated into the ICDs without proper quality controls. This allegation is irrelevant because there is no allegation that the device included components from an outside supplier. Nor has plaintiff identified any particular quality controls that were not followed or any corresponding FDA requirements for such quality controls. In any event, the FDA’s approval of the TELIGEN Model E102 ICD includes approval of all its component parts. Courts have found that once a device’s PMA is granted, it applies to all aspects and all components of a device, and courts have rejected similar attempts by plaintiffs to separate a PMA-approved device from its components. See, e.g., Gross v. Stryker Corp., 858 F. Supp. 2d 466, 487 (W.D. Pa. 2012) (“a device receiving premarket approval cannot be separated into its component parts to avoid application of express preemption”); Riley v. Cordis Corp., 625 F. Supp. 2d 769, 780 (D. Minn. 2009) (holding it would be nonsensical and impossible Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 20 of 33 Page ID #:561 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 “to pick apart the components of a medical device and apply different preemption analyses to different components”); Bentzley v. Medtronic, Inc., 827 F. Supp. 2d 443, 452 (E.D. Pa. Nov. 29, 2011) (holding preemption applies to device as a whole, not its component parts, and collecting cases holding same). Second, plaintiffs have added an assertion that “Defendants have settled civil and/or criminal case(s) alleging that Defendants knew about the faulty capacitors… .” (SAC ¶ 14.) This allegation fails because there is still nothing relating to any particular manufacturing defects, let alone findings or agreements that such defects violated FDA requirements. Prior cases are irrelevant to preemption. Third, the conclusory allegations added in paragraphs 33 through 37 likewise remain deficient because there is nothing relating to any particular manufacturing defects, let alone findings or agreements that such defects violated FDA requirements. These allegations also mimic the prior allegations in paragraphs 37 through 41 of the first amended complaint, which the Court already found are insufficient to survive preemption. 2. The Products Liability - Failure to Warn Claim Is Preempted Because No Viable Parallel Claims Are Alleged. As set forth in the Court’s prior order: “To plead a failure to warn parallel claim, a plaintiff must allege the defendant failed to report adverse events and that the failure to warn caused the plaintiff’s injuries.” Weaver, 2017 WL 680725, at *7 (citing Houston v. Medtronic, 957 F. Supp. 2d 1166, 1177 (C.D. Cal. 2013). The complaint “must include allegations of actual adverse events that Defendants did not report.” (Id. (quoting Grant v. Corin Group PLC, No. 15cv169-CAB-BLM, 2016 WL 4447523, at *7 (S.D. Cal. Jan. 15, 2016) (internal quotation marks omitted). Plaintiffs’ failure to warn cause of action is in amended paragraphs 44-47 and 60 of the second amended complaint. These allegations cover three general topics that do not escape preemption: (1) the vague “monitoring process” (SAC ¶¶ 44, 48, 60); Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 21 of 33 Page ID #:562 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 (2) failure to submit an adverse event (SAC ¶ 45); and (3) failure to directly notify plaintiffs of the recall (SAC ¶ 46-47). First, plaintiffs’ amendments begin by reiterating their prior assertion that Boston Scientific was monitoring plaintiffs’ recalled unit without his knowledge. (SAC ¶ 44.) Plaintiffs vaguely allege that this violates the FDCA, and it was never either reported to or approved by the FDA. (Id.) Plaintiffs’ claim that Boston Scientific was somehow “monitoring” the device fails, because the memory capability of the E102 ICD was one of the components of a device, and courts have rejected similar attempts by plaintiffs to separate a PMA-approved device from its components, as set forth above. See, e.g., Gross, 858 F. Supp. 2d at 487; Riley, 625 F. Supp. 2d at 780; Bentzley, 827 F. Supp. 2d at 452. In addition, plaintiffs have not alleged any particular violations of any FDA requirements relating to this vague “monitoring” claim, or any state requirements that parallel the FDA requirements to support such a claim. Second, plaintiffs reassert that Boston Scientific failed to report adverse events associated with the ICDs including the Subject ICD models.” (SAC ¶ 45.) General allegations that a defendant failed to report adverse events to the FDA are insufficient-plaintiffs must include specific allegations of actual adverse events. See, e.g., Weaver, 2017 WL 680725, at *7. Plaintiffs’ basis for the adverse events now appears to be the vague “monitoring process.” (SAC ¶ 45.) But monitoring “end user clients such as Plaintiff”-even if taken as true-would not be an event reasonably suggesting a device may have a caused or contributed to a death or serious injury, so it would not qualify as a reportable event under 21 C.F.R. § 803.50(a). At most, plaintiffs allege a single adverse event based on Boston Scientific’s purported failure to report the alleged monitoring of Mr. Paturzo. (See SAC ¶¶ 44-45, 55.) Even assuming, arguendo, that this allegation was true, failing to notify the FDA of a plaintiff’s injury could have no causal relationship to the injury he suffered. Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 22 of 33 Page ID #:563 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 Simmons, 2013 WL 1207421, at *5; Weaver, 2017 WL 680725, at *8 (collecting cases). To the extent that plaintiffs are alleging Boston Scientific did not report any adverse events (see SAC ¶ 46), this is demonstrably false. The FDA’s publicly- available MAUDE database establishes adverse event reports have been filed with the FDA. Funke v. Sorin Group USA, Inc., 147 F. Supp. 3d 1017, 1025 (C.D. Cal. 2015); RJN Ex. E [MAUDE Database Search for Model E102 prior to January 29, 2010]. The conclusory and false allegations lack the factual and legal support to maintain a cause of action, even if this claim is not preempted. Id.; see also Hawkins v. Medtronic, Inc., No. 1:13-cv-00499 AWI SKO, 2014 WL 346622, at *8 (E.D. Cal. Jan. 30, 2014) (dismissing claims based on failure-to-report adverse events to the FDA on the ground that it was not sufficiently pled where plaintiff provided no dates to discern timely reporting). Plaintiffs’ claim is also expressly preempted to the extent it seeks to impose liability for not reporting adverse events to plaintiffs or their healthcare providers, as opposed to the FDA. (See SAC ¶ 45.) Plaintiffs have not-and cannot-cite any federal requirements to report adverse events to plaintiffs or their healthcare providers directly, so this claim is preempted. Funke, 147 F. Supp. 3d at 1024-26. Third, turning to the next “repackaged allegation,” plaintiffs now assert that Boston Scientific violated 21 C.F.R. 7.49 for failing to notify plaintiff and his implanting surgeon and/or cardiologist of a recall. (SAC ¶¶ 46-48, 60.) As the Court previously found: At most, 21 C.F.R. §§ 7.49 and 7.50 require Defendants to inform their “direct accounts” about any recall and to make available to the public in the weekly FDA Enforcement Report a descriptive listing of each new recall. Neither regulation imposes a duty on Defendants to directly warn Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 23 of 33 Page ID #:564 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 Plaintiffs, nor is there any allegation that Plaintiffs or Plaintiffs’ health care providers are “direct accounts” of Defendants. (Dkt. No. 26, at p. 11.) Post-recall communications are also under the authority of the FDA. Gates v. Medtronic, Inc., 192 F. Supp. 3d 704 (W.D. Tex. 2016) (“The law is clear in that the FDA regulates in this area; a manufacturer’s recall and post-recall communications do fall under the authority of the FDA.”). Here, as in Gates, plaintiffs do not point to any specific federal requirement that mirrors the duties imposed by their common-law causes of action, so plaintiffs have failed to adequately allege a parallel claim. In particular, under California’s learned intermediary doctrine, a medical device manufacturer’s duty to warn runs to the physician, not to the patient. See, e.g., Carlin v. Superior Court, 13 Cal. 4th 1104, 1116 (1996); Brown v. Superior Court, 44 Cal. 3d 1049, 1062 n.9 (1988); Valentine v. Baxter Healthcare Corp., 68 Cal. App. 4th 1467, 1483 (1999) [“In the case of prescription drugs and implants, the physician stands in the shoes of the ‘ordinary user’ because it is through the physician that a patient learns of the properties and proper use of the drug or implant.”].) “The doctor is intended to be an intervening party in the full sense of the word. Medical ethics as well as medical practice dictate independent judgment, unaffected by the manufacturer’s control, on the part of the doctor.” Plenger v. Alza Corp., 11 Cal. App. 4th 349, 362 n.6 (1992) (internal citation omitted). Plaintiff has not-and cannot-cite any California authority creating a duty to warn merely because a representative of a medical device manufacturer met with plaintiffs and was present during the surgery. See, e.g., Smith v. St. Jude Medical, Inc., 217 Cal. App. 4th 313 (2013); Kennedy v. Medtronic, Inc., 366 Ill. App. 3d 298 (2006). In addition, plaintiffs have not alleged sufficient facts to support that they or their healthcare providers are “direct accounts” under 21 C.F.R. § 7.49. (See, e.g., SAC ¶¶ 46, 60.) Plaintiffs merely allege that they met with unidentified Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 24 of 33 Page ID #:565 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 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 representative(s) of Boston Scientific who were present at time with implant, and then make the illogical leap that they and their healthcare providers are thus “direct accounts” under federal requirements. This is not a plausible interpretation, and this label/conclusion is not a “fact” entitled to the presumption of truth. Iqbal, 556 U.S. at 678-79; Twombly, 550 U.S. at 555. While “direct accounts” is not defined under the applicable federal requirements (see 21 C.F.R. § 7.3), the plain meaning of the words is a party that directly purchases devices from Boston Scientific. See, e.g., RxUSA Wholesale, Inc. v. Alcon Labs., Inc., 661 F. Supp. 2d 218, 231 (E.D.N.Y 2009) (discussing a drug manufacturer informing a secondary wholesaler that it is not eligible for a “direct account” with the manufacturer because, among other things, it lacked sufficient “direct purchasing relationships with other manufacturers”). Because the subject product is a prescription medical device, it is never purchased directly by a patient such as plaintiff; there must always be a healthcare provider in between. In addition, plaintiffs’ interpretation would render section 7.49(a)(3) meaningless because any customer that had any interaction with a sales representative would be a direct account, leaving no “customers” for direct accounts to notify where appropriate. The only reasonable interpretation is that a patient receiving an implanted medical device such as the one at issue here is a “customer,” not a “direct account.” The direct accounts would be the healthcare providers-not the patients. This is bolstered by the fact that the “Action” identified on the FDA website for the advisory is that “[a]n Important Medical Device Information letter dated August 2013 was sent to implanting and following physicians.” (RJN, Ex. D [FDA Public Information on LV Capacitor Advisory] (emphasis added).) This is also consistent with the Court’s prior holding that “[n]either regulation imposes a duty on Defendants to directly warn Plaintiffs.” (Dkt. No. 26 at p. 11.) Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 25 of 33 Page ID #:566 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 17 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 Furthermore, a sufficient causal link in not alleged between the recall and plaintiffs’ injuries. The “Action” identified on the FDA website did not call for surgical removal and replacement of the recalled devices, it involved an “Important Medical Device Information letter” that, among other things, “gives recommendations for monitoring patients.” (RJN, Ex. D [FDA Public Information on LV Capacitor Advisory].) Plaintiffs’ repeatedly allege that Mr. Paturzo’s device was, in fact, being monitored, so any causal link is broken between the recall and the alleged injuries. In short, plaintiffs are seeking to add an additional requirement than the FDA’s advisory, so plaintiffs’ claims are expressly preempted. 3. Breach of Implied Warranty And Negligence Claims Are Preempted Because No Viable Parallel Claims Are Alleged. Plaintiffs’ third cause of action for breach of implied warranties and fourth cause of action for negligence do not even attempt to allege any specific allegations to of any federal requirements to support such claims. These claims should be dismissed without leave to amend. IV. PLAINTIFFS’ CLAIMS ARE BARRED BY THE STATUTE OF LIMITATIONS. The statute of limitations for personal injury actions in California is two years. Cal. Code Civ. Proc. § 335.1. As a general rule, a cause of action accrues “when, under the substantive law, the wrongful act is done, or the wrongful result occurs, and the consequent liability arises.” Norgart v. Upjohn Co., 21 Cal. 4th 383, 397 (1999) (quotations omitted). An exception to the general rule of accrual of a cause of action is the “discovery rule,” which “postpones accrual of a cause of action until the plaintiff discovers, or has reason to discover, the cause of action.” Id. A plaintiff has reason to discover a cause of action when he “at least suspects a factual basis, as opposed to a legal theory, for its elements, even if he lacks knowledge Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 26 of 33 Page ID #:567 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 18 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 thereof-when, simply put, he at least ‘suspects . . . that someone has done something wrong’ to him.” Id. (quoting Jolly v. Eli Lilly & Co., 44 Cal. 3d 1103, 1110 (1988)). The term “wrong” when used in this analysis is “not in any technical sense, but rather in accordance with its ‘lay understanding.’ ” Id. at 397-98 (quoting Jolly, 44 Cal.3d at 1110 n.7). “[T]he limitations period begins once a plaintiff has ‘notice or information of circumstances to put a person on inquiry.’” Jolly, 44 Cal. 3d at 1110- 11 (italics in original). Once a suspicion of a wrong exists, “it is clear that the plaintiff must go find the facts; she cannot wait for the facts to find her.” Id. at 1111. “[T]he the discovery rule uses an objective test that looks not to what the particular plaintiff actually knew but to what a reasonable inquiry would have revealed.” Mills v. Forestex Co., 108 Cal. App. 4th 625, 648 (2003). “In order to adequately allege facts supporting a theory of delayed discovery, the plaintiff must plead that, despite diligent investigation of the circumstances of the injury, he or she could not have reasonably discovered facts supporting the cause of action within the applicable statute of limitations period.” Fox v. Ethicon Endo-Surgery, Inc., 35 Cal. 4th 797, 809 (2005). Therefore, as the Ninth Circuit recently summarized, “[u]nder California law, the discovery rule delays accrual of claims only when a plaintiff has no reason to suspect wrongdoing and cannot discover his or her claims with reasonable diligence.” Plumlee v. Pfizer, Inc., 664 F. App’x. 651, 652-53 (9th Cir. Nov. 9, 2016). Here, while plaintiffs define the “Subject ICD” to be only the TELIGEN Model E102 (SAC ¶ 10), plaintiffs also allege defendants falsely represented that a Guidant Model T135, Serial Number 943073 ICD, would also last for ten years. (SAC ¶ 9.) However, any claims regarding the Guidant Model T135 are preempted under Riegel and its progeny for the same reasons previously discussed. And any claims regarding the Model T135 are also barred by the statute of limitations. Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 27 of 33 Page ID #:568 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 19 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 The Model T135 was allegedly implanted more than ten years ago on or about October 10, 2005, and had to be replaced in less than ten years when the Model 102 was implanted on or about January 29, 2010. (SAC ¶¶ 9-10.) “A reasonable person who is implanted with a medical device, which requires a second corrective surgery to remove the device and correct injuries resulting there from . . . should suspect the defectiveness of the device and conduct a reasonable inquiry and examination into the suitability of the device.” Coleman v. Boston Scientific Corp., No. 1:10-CV-01968- OWW, 2011 WL 3813173, at *3 (E.D. Cal. Aug. 29, 2011); see also Henderson v. Pfizer, Inc., 285 F. App’x. 370, 372 (9th Cir.2008) (holding claim arising out of injury caused by medical device accrued at the time plaintiff required surgery to remove the device). A reasonable person who had an ICD replaced due to alleged battery depletion is on notice of his claims when the ICD is replaced-here, more than 6 years before filing the complaint. Accordingly, any claim based on the Model T135 device is precluded by the two-year statute of limitations. In addition, plaintiffs allege both the Model T135 and the Model E102 “were defective and had been recalled” and they “were prone to experience premature battery depletion and/or failure.” (SAC ¶ 43(a), (e).) Plaintiffs were at least on inquiry notice of the potential battery depletion before 10 years of use when the Model T135 was replaced with the Model E102 in January 2010. As plaintiffs were on inquiry notice of the claims, plaintiffs are also charged with knowledge of the information that would have been revealed by a reasonable investigation. Fox, 35 Cal. 4th at 808. Plaintiffs’ claims are purportedly premised on the voluntary product advisory concerning a low voltage capacitor that can lead to premature battery depletion, which was issued on August 13, 2013. (RJN, Ex. D [FDA Public Information on LV Capacitor Advisory].) Plaintiffs are charged with this publicly-available information regarding potential battery depletion, so their claims accrued no later than August 13, Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 28 of 33 Page ID #:569 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 20 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 2013-more than 3 years before filing of the complaint. Therefore, plaintiffs’ claims based on the Model E102 are also precluded by the statute of limitations. 3 V. PLAINTIFFS’ CLAIMS FAIL ON ADDITIONAL GROUNDS. A. Plaintiffs’ Breach of Implied Warranties Claim Fails As A Matter Of California Law. The Court should dismiss plaintiffs’ cause of action for breach of implied warranties because plaintiffs were not in privity with defendants. In the prescription medical device context, warnings and descriptions are directed to the physician, not the patient/plaintiff. Valentine v. Baxter Healthcare Corp., 68 Cal. App. 4th 1467, 1483 (1999) (patient is presumed to have learned “through the physician . . . of the properties and proper use of the . . . implant”); see also Sherman v. Stryker Corp., No. SACV 09-224, 2009 WL 2241664, at *3 (C.D. Cal. Mar. 30, 2009). This is because physicians “appreciate the fact that all prescription medical products involve inherent risks, known and unknown,” and they do not expect that such products are without such risks. Brown v. Super. Ct., 44 Cal. 3d 1049, 1061 (1988). Any implied warranty, assuming there is one, must be evaluated by a physician; therefore, the patient lacks the privity required to establish a claim for breach of implied warranty. Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039, 1058-59 (2008) (holding that breach of implied warranty claim against a medical device manufacturer was improper due to lack of privity between patient and manufacturer). 3 Plaintiffs have not alleged any defect in the third Boston Scientific ICD device implanted in Mr. Paturzo on or about August 25, 2015. Nor can they. Plaintiffs cannot “manufacture standing” by buying a product for the purpose of establishing an “injury” that will permit litigation. See, e.g., Leong v. Square Enix of Am. Holdings, Inc., No. CV 09-4484 PSG (VBKx), 2010 WL 1641364, at *3 (C.D. Cal. Apr. 20, 2010), aff’d, 462 F. App’x 688 (9th Cir. 2011); Wright v. Gen. Motors Acceptance Corp., No. 09CV2666 JM(AJB), 2012 WL 253157, at *4 (S.D. Cal. Jan. 25, 2012); Buckland v. Threshold Enters., Ltd., 155 Cal. App. 4th 798, 806-809 (2008). Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 29 of 33 Page ID #:570 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 21 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 Although plaintiffs allege that unidentified representative(s) consulted with Mr. Paturzo before the procedure and were present at the procedure, they still have not- and cannot-allege privity of contract for an implanted medical device available only through a prescription, such as the device at issue here. There is only privity of contract between Boston Scientific and certain healthcare providers, so plaintiffs’ implied warranties claim fails. In addition, the Court previously held that plaintiffs’ claim fails because they “fail to plead who those agents were, what representations they made to Mr. Paturzo, and the context in which those representations were made.” (Dkt. No. 26, at p. 12.) While the amended complaint adds paragraphs 67 and 68, the same deficiencies remain-plaintiffs have not identified who made representations, any particular representations, or the context in which such representations were made. Moreover, the added allegations are fatal to plaintiffs’ warranty claims. Despite the prior general assertion that Boston Scientific represented the ICD would last for at least ten years (without setting forth who, where, when, or how such representation was made [see SAC ¶ 10]), the only statement specifically included by the unidentified representative(s) is “the expected 10-year battery life.” (SAC ¶ 67.) A statement on an expectation is not an actionably promise or statement of fact. (See Cal. U. Com. Code § 2314(2)(f).) Therefore, not only have plaintiffs failed to allege facts showing liability is plausible, they have pleaded facts that undermine their own theory. See Sprewell v. Golden State Warriors, 266 F.3d 979, 988-89 (9th Cir. 2001) (“[A] plaintiff can . . . plead himself out of a claim by including unnecessary details contrary to his claims.”). Plaintiffs’ cause of action for breach of implied warranties should be dismissed without leave to amend. Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 30 of 33 Page ID #:571 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 22 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 B. The Loss Of Consortium Claim Is Derivative Of The Other Claims So It Fails For The Same Reasons. Because this claim is derivative of plaintiffs’ other claims, it must be dismissed. See Weaver, 2017 WL 680725, at *9. VI. CONCLUSION For the foregoing reasons, Boston Scientific respectfully requests the Court grant the motion to dismiss plaintiffs’ second amended complaint, and each of the causes of action alleged therein, without leave to amend. Dated: June 2, 2017 Respectfully submitted, SHOOK HARDY & BACON L.L.P. By: /s/ Brian P. Ziska Brian P. Ziska Attorneys for Defendant Boston Scientific Corporation and Guidant LLC Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 31 of 33 Page ID #:572 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 23 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 PROOF OF SERVICE I am employed in the County of Orange, State of California. I am over the age of 18 and not a party to the within action. My business address is 5 Park Plaza, Suite 1600, Irvine, California, 92614. On June 2, 2017, I served on the interested parties in said action the within: DEFENDANTS BOSTON SCIENTIFIC CORPORATION’S AND GUIDANT LLC’S NOTICE OF MOTION AND MOTION TO DISMISS SECOND AMENDED COMPLAINT by placing a true copy thereof in a sealed envelope(s) addressed as stated on the attached mailing list. (MAIL) I am readily familiar with this firm's practice of collection and processing correspondence for mailing. Under that practice it would be deposited with the U.S. postal service on that same day in the ordinary course of business. I am aware that on motion of party served, service is presumed invalid if postal cancellation date or postage meter date is more than 1 day after date of deposit for mailing in affidavit. (BY FEDERAL EXPRESS, AN OVERNIGHT DELIVERY SERVICE) By placing a true and correct copy of the above document(s) in a sealed envelope addressed as indicated above and causing such envelope(s) to be delivered to the FEDERAL EXPRESS Service Center, on __________, to be delivered by their next business day delivery service on ______, to the addressee designated. (ELECTRONIC FILING) I provided the document(s) listed above electronically through the CM/ECF system pursuant to the instructions set forth in the Local Rules for the United States District Court for the Central District of California. I declare that I am employed in the office of a member of the bar of this court at whose direction the service was made. I declare under penalty of perjury under the law of the State of California, and the United States, that the foregoing is true and correct. Executed on June 2, 2017, at Irvine, California. Brian P. Ziska /s/ Brian P. Ziska (Type or print name) (Signature) Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 32 of 33 Page ID #:573 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 24 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410223 V4 SERVICE LIST Jay F. Stocker, Esq. STOCKER & LANCASTER, LLP 19200 Von Karman Avenue The Atrium, Suite 600 Irvine, CA 92612 Tel: (949) 622-5575 Fax: (949) 622-5562 Attorney for Plaintiff Case 8:16-cv-02174-JLS-KES Document 31 Filed 06/02/17 Page 33 of 33 Page ID #:574 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 DECLARATION IN SUPPORT OF DEFENDANTS’ MOTION TO DISMISS 8:16-cv-2174 JLS (KESx) 410219 V1 Eva M. Weiler (SBN: 233942) eweiler@shb.com Brian P. Ziska (SBN: 272043) bziska@shb.com SHOOK, HARDY & BACON L.L.P. Jamboree Center 5 Park Plaza, Suite 1600 Irvine, California 92614-2546 Telephone: 949-475-1500 Facsimile: 949-475-0016 Attorneys for Defendants Boston Scientific Corporation and Guidant LLC UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA PETER PATURZO; NAN PATURZO, Plaintiffs, vs. BOSTON SCIENTIFIC CORPORATION; GUIDANT LLC, formerly known as GUIDANT CORPORATION; GUIDANT SALES LLC, formerly known as GUIDANT SALES CORPORATION; and DOES 1 through 50, inclusive, Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case No. 8:16-cv-2174 JLS (KESx) DECLARATION OF BRIAN P. ZISKA IN SUPPORT OF DEFENDANTS BOSTON SCIENTIFIC CORPORATION AND GUIDANT LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PURSUANT TO FED. R. CIV. P. 12(B)(6) Date: July 28, 2017 Time: 2:30 p.m. Dept.: 10A [Filed concurrently with Motion; Request for Judicial Notice; [Proposed] Order] Complaint Filed: August 16, 2016 First Am. Compl. Filed: February 13, 2017 Second Am. Compl. Filed: May 12, 2017 I, Brian P. Ziska, do hereby declare: 1. The following statements are within my personal knowledge and if sworn as a witness, I could and would testify competently thereto. Case 8:16-cv-02174-JLS-KES Document 31-1 Filed 06/02/17 Page 1 of 4 Page ID #:575 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 DECLARATION IN SUPPORT OF DEFENDANTS’ MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410219 V1 2. I am an attorney licensed to practice in the State of California and I am an associate with the law firm of Shook, Hardy & Bacon, L.L.P., counsel of record for defendants Boston Scientific Corporation and Guidant LLC (collectively “Boston Scientific”). 3. The parties have met and conferred on the issues raised in the motion to dismiss prior, including the issues of preemption and statute of limitations, to the original motion to dismiss, the motion to dismiss the first amended complaint, and following the Court’s order granting the motion to dismiss the first amended complaint (Dkt. No. 26), as required by Local Rule 7-3. Following the Court’s order, the parties further met and conferred and were unable to reach a resolution, but the parties agreed to a stipulation to continue the Rule 26(f) conference and establish a briefing schedule on Boston Scientific’s anticipated motion to dismiss. (Dkt. No. 27.) On May 1, 2017, the Court issued an order granting the parties’ stipulation, including the request to establish a briefing schedule on this motion. (Dkt. No. 29.) I declare under penalty of perjury that the foregoing statements are true and correct. Executed this 2nd day of June, 2017 in Irvine, California. /s/ Brian P. Ziska Brian P. Ziska Case 8:16-cv-02174-JLS-KES Document 31-1 Filed 06/02/17 Page 2 of 4 Page ID #:576 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 DECLARATION IN SUPPORT OF DEFENDANTS’ MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410219 V1 PROOF OF SERVICE I am employed in the County of Orange, State of California. I am over the age of 18 and not a party to the within action. My business address is 5 Park Plaza, Suite 1600, Irvine, California, 92614. On June 2, 2017, I served on the interested parties in said action the within: DECLARATION OF BRIAN P. ZISKA IN SUPPORT OF DEFENDANTS BOSTON SCIENTIFIC CORPORATION AND GUIDANT LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PURSUANT TO FED. R. CIV. P. 12(B)(6) by placing a true copy thereof in a sealed envelope(s) addressed as stated on the attached mailing list. (MAIL) I am readily familiar with this firm's practice of collection and processing correspondence for mailing. Under that practice it would be deposited with the U.S. postal service on that same day in the ordinary course of business. I am aware that on motion of party served, service is presumed invalid if postal cancellation date or postage meter date is more than 1 day after date of deposit for mailing in affidavit. (BY FEDERAL EXPRESS, AN OVERNIGHT DELIVERY SERVICE) By placing a true and correct copy of the above document(s) in a sealed envelope addressed as indicated above and causing such envelope(s) to be delivered to the FEDERAL EXPRESS Service Center, on __________, to be delivered by their next business day delivery service on ______, to the addressee designated. (ELECTRONIC FILING) I provided the document(s) listed above electronically through the CM/ECF system pursuant to the instructions set forth in the Local Rules for the United States District Court for the Central District of California. I declare that I am employed in the office of a member of the bar of this court at whose direction the service was made. I declare under penalty of perjury under the law of the State of California, and the United States, that the foregoing is true and correct. Executed on June 2, 2017, at Irvine, California. Brian P. Ziska /s/ Brian P. Ziska (Type or print name) (Signature) Case 8:16-cv-02174-JLS-KES Document 31-1 Filed 06/02/17 Page 3 of 4 Page ID #:577 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 DECLARATION IN SUPPORT OF DEFENDANTS’ MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 410219 V1 SERVICE LIST Jay F. Stocker, Esq. STOCKER & LANCASTER, LLP 19200 Von Karman Avenue The Atrium, Suite 600 Irvine, CA 92612 Tel: (949) 622-5575 Fax: (949) 622-5562 Attorney for Plaintiff Case 8:16-cv-02174-JLS-KES Document 31-1 Filed 06/02/17 Page 4 of 4 Page ID #:578 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 [PROPOSED] ORDER GRANTING BOSTON SCIENTIFIC CORPORATION’S MOTION TO DISMISS 8:16-cv-2174 JLS (KESx) 410215 V1 UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA PETER PATURZO; NAN PATURZO, Plaintiffs, vs. BOSTON SCIENTIFIC CORPORATION; GUIDANT LLC, formerly known as GUIDANT CORPORATION; GUIDANT SALES LLC, formerly known as GUIDANT SALES CORPORATION; and DOES 1 through 50, inclusive, Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case No. 8:16-cv-2174 JLS (KESx) [PROPOSED] ORDER GRANTING DEFENDANT BOSTON SCIENTIFIC CORPORATION’S MOTION TO DISMISS PURSUANT TO FED. R. CIV. P. 12(B)(6) Date: July 28, 2017 Time: 2:30 p.m. Dept.: 10A The motion of defendants Boston Scientific Corporation and Guidant LLC (collectively “Boston Scientific”) for dismissal of the second amended complaint of plaintiffs Peter Paturzo’s and Nan Paturzo’s first amended complaint pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure came on regularly for hearing by the Court. The Court, having reviewed all of the pleadings, records, and files in this matter, and having heard oral argument of the parties, and good cause appearing therefor, hereby orders that the motion is GRANTED based on the following grounds: Case 8:16-cv-02174-JLS-KES Document 31-2 Filed 06/02/17 Page 1 of 4 Page ID #:579 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 [PROPOSED] ORDER GRANTING BOSTON SCIENTIFIC CORPORATION’S MOTION TO DISMISS 8:16-cv-2174 JLS (KESx) 410215 V1 1. Boston Scientific’s requests for judicial notice are granted in their entirety. 2. Plaintiffs’ state law claims are preempted by federal law because the medical device at issue in this action, a TELIGEN Model E102 implantable cardioverter defibrillator (“ICD”), serial number 249953, is a Class III Medical Device that was evaluated under the FDA’s premarket approval process. Plaintiffs also fail to plead any non-preempted parallel claims regarding the Model E102 ICD. See, e.g., Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008); Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S. 341, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2008). 3. Plaintiffs’ claims are barred by the statute of limitations. Cal. Civ. Proc. Code § 335.1. 4. The complaint fails to state a claim for breach of implied warranty because plaintiffs have not identified who made representations, any particular actionable representations, or the context in which such representations were made. 5. The loss of consortium claim fails as it is wholly derivative of the other claims, so the loss of consortium claim also fails. Dated: _______________, 2017 Hon. Josephine L. Staton United States District Judge Case 8:16-cv-02174-JLS-KES Document 31-2 Filed 06/02/17 Page 2 of 4 Page ID #:580 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 [PROPOSED] ORDER GRANTING BOSTON SCIENTIFIC CORPORATION’S MOTION TO DISMISS 8:16-cv-2174 JLS (KESx) 410215 V1 PROOF OF SERVICE I am employed in the County of Orange, State of California. I am over the age of 18 and not a party to the within action. My business address is 5 Park Plaza, Suite 1600, Irvine, California, 92614. On June 2, 2017, I served on the interested parties in said action the within: [PROPOSED] ORDER GRANTING DEFENDANT BOSTON SCIENTIFIC CORPORATION’S MOTION TO DISMISS PURSUANT TO FED. R. CIV. P. 12(B)(6) by placing a true copy thereof in a sealed envelope(s) addressed as stated on the attached mailing list. (MAIL) I am readily familiar with this firm's practice of collection and processing correspondence for mailing. Under that practice it would be deposited with the U.S. postal service on that same day in the ordinary course of business. I am aware that on motion of party served, service is presumed invalid if postal cancellation date or postage meter date is more than 1 day after date of deposit for mailing in affidavit. (BY FEDERAL EXPRESS, AN OVERNIGHT DELIVERY SERVICE) By placing a true and correct copy of the above document(s) in a sealed envelope addressed as indicated above and causing such envelope(s) to be delivered to the FEDERAL EXPRESS Service Center, on __________, to be delivered by their next business day delivery service on ______, to the addressee designated. (ELECTRONIC FILING) I provided the document(s) listed above electronically through the CM/ECF system pursuant to the instructions set forth in the Local Rules for the United States District Court for the Central District of California. I declare that I am employed in the office of a member of the bar of this court at whose direction the service was made. I declare under penalty of perjury under the law of the State of California, and the United States, that the foregoing is true and correct. Executed on June 2, 2017, at Irvine, California. Brian P. Ziska /s/ Brian P. Ziska (Type or print name) (Signature) Case 8:16-cv-02174-JLS-KES Document 31-2 Filed 06/02/17 Page 3 of 4 Page ID #:581 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 [PROPOSED] ORDER GRANTING BOSTON SCIENTIFIC CORPORATION’S MOTION TO DISMISS 8:16-cv-2174 JLS (KESx) 410215 V1 SERVICE LIST Jay F. Stocker, Esq. STOCKER & LANCASTER, LLP 19200 Von Karman Avenue The Atrium, Suite 600 Irvine, CA 92612 Tel: (949) 622-5575 Fax: (949) 622-5562 Attorney for Plaintiff Case 8:16-cv-02174-JLS-KES Document 31-2 Filed 06/02/17 Page 4 of 4 Page ID #:582