Peter Paturzo et al v. Boston Scientific Corporation et al

NOTICE OF MOTION AND MOTION to Dismiss Case

C.D. Cal.March 15, 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) 388690 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) DEFENDANTS BOSTON SCIENTIFIC CORPORATION AND GUIDANT LLC’S NOTICE OF MOTION AND MOTION TO DISMISS FIRST AMENDED COMPLAINT Date: April 21, 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 TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on April 21, 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 21 Filed 03/15/17 Page 1 of 32 Page ID #:333 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) 388690 v1 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 first cause of action for strict liability for design defects is precluded as a matter of California law. There is no strict liability for design defect of a medical device under California law. Brown v. Superior Court, 44 Cal. 3d 1049, 1061-66 (1988); Hufft v. Horowitz, 4 Cal. App. 4th 8, 19 (1992). 4. The complaint fails to state a claim for breach of implied warranty because plaintiffs do not allege they were in privity with BSC or relied on its skill and judgment in deciding to use the mesh device. See Blanco v. Baxter Healthcare, 158 Cal. App. 4th 1039 (2008). 5. 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 on March 8, March 14, and March 15, 2017, 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 21 Filed 03/15/17 Page 2 of 32 Page ID #:334 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) 388690 v1 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: March 15, 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 21 Filed 03/15/17 Page 3 of 32 Page ID #:335 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) 388690 v1 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 .......................................................9 1. Plaintiffs Have Not Factually Substantiated a Violation of Federal Requirements Related to the Device at Issue ...................10 a. The Allegations Regarding the General Provision for an “Adulterated” Device Do Not Support a Parallel Claim that Survives Preemption..............................................11 b. The Allegations Regarding General Guidelines for Quality Control Measures Do Not Support a Parallel Claim that Survives Preemption..............................................13 c. The Allegations Regarding Failure to Report Adverse Events Do Not Support a Parallel Claim that Survives Preemption..............................................................................14 d. The Allegations Regarding Post-Recall Communications Do Not Support a Parallel Claim that Survives Preemption ....15 e. The Breach of Implied Warranty and Negligence Claims Do Not Include Any Parallel Claim Allegations .....................16 2. Plaintiffs Cannot Allege A Causal Nexus Between A Federal Violation and Their Alleged Injuries............................................17 IV. PLAINTIFFS’ CLAIMS ARE BARRED BY THE STATUTE OF LIMITATIONS ...............................................................................................18 V. PLAINTIFFS’ CLAIMS FAIL ON ADDITIONAL GROUNDS.....................20 A. Plaintiffs’ Strict Liability For Design Defect Claim Fails As A Matter Of California Law ......................................................................20 B. Plaintiffs’ Breach of Implied Warranty Claim Fails As A Matter Of California Law..................................................................................21 C. The Loss Of Consortium Claim Is Derivative Of The Other Claims So Fails For The Same Reasons .............................................................22 VI. CONCLUSION ...............................................................................................23 Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 4 of 32 Page ID #:336 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) 388690 v1 TABLE OF AUTHORITIES Page(s) CASES Ashcroft v. Iqbal, 556 U.S. 662, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009) ..................................2 Bell Atl. Corp. v. Twombly, 550 U.S. 544, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007) ..................................2 Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039, 70 Cal. Rptr. 3d 566 (2008) .................................15, 22 Brown v. Superior Court, 44 Cal. 3d 1049, 245 Cal. Rptr. 412 (1988)................................................20, 21 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) ............................7, 12 Cohen v. Guidant Corp., No. CV-05-8070-R, 2011 WL 637472 (C.D. Cal. Feb. 15, 2011) ..... 6, 9, 18, 17 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)................7 Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085 (C.D. Cal. 2011) ............................................. 6, 8, 15, 17 Fox v. Ethicon Endo-Surgery, Inc., 35 Cal. 4th 797 (2005) ...............................................................................19, 20 Funke v. Sorin Group USA, Inc., 147 F. Supp. 3d 1017, 1025 (C.D. Cal. 2015) ..................................................14 Gates v. Medtronic, Inc., 192 F. Supp. 3d 704 (W.D. Tex. 2016) ............................................................16 Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 5 of 32 Page ID #:337 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) 388690 V1 Gillman v. Boston Scientific Corp., No. 11-3067-CL, 2012 WL 892239 (D. Or. Jan. 27, 2012) ................................7 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 Hickman v. Sofamor-Danek Group, Inc., No. C 95-01095, 1999 WL 606690, 1999 U.S. Dist. LEXIS 4384 (N.D. Cal. Feb. 17, 1999)..................................................................................................22 Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004)...............................................................................9 Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y.2009) ...............................................................17 Hufft v. Horowitz, 4 Cal. App. 4th 8 (1992) ..................................................................................21 Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582 (E.D.N.Y. Dec. 28, 2009) ................................................13 In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147 (D. Minn. 2009)............................................... 7, 8, 10, 15 In re Medtronic, Inc., Sprint Fidelis Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010)............................................................................8 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) ................................................................................................................6 Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC(RNBx), 2014 WL 819392 (C.D. Cal. Feb. 14, 2014) ................................................................................................................6 Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 6 of 32 Page ID #:338 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) 388690 V1 Knoppel v. St. Jude Medical, Inc., No. SACV 13-383 JVS (ANx), 2013 WL 3803612 (C.D. Cal. May 7, 2013)...............................................................................6, 10 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)............................................................. 1, 3, 6, 9, 15, 17 Malonzo v. Mentor Worldwide, LLC, No. C 14-01144 JSW, 2014 WL 2212235 (N.D. Cal. May 28, 2014)................9 McGuan v. Endovascular Techs., Inc., 182 Cal. App. 4th 974, 106 Cal. Rptr. 3d 277 (2010) ........................................6 Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (1996) ..............................5, 9 Mills v. Forestex Co., 108 Cal. App. 4th 625 (2003)...........................................................................18 Nimtz v. Cepin, No. 08cv1294 L(AJB), 2011 WL 831182 (S.D. Cal. Mar. 3, 2011) .................10 Norgart v. Upjohn Co., 21 Cal. 4th 383 (1999) .....................................................................................18 Parker v. Stryker Corp., 584 F. Supp. 2d 1298 (D. Colo. 2008) .............................................................17 Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013)..................................................................7, 8, 12 Plumlee v. Pfizer, Inc., 664 F. App’x. 651 (9th Cir. Nov. 9, 2016) .......................................................19 Rhynes v. Stryker Corp., No. 10-5619 SC, 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011) .....................6, 7 Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006) ...............................................................................3 Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 7 of 32 Page ID #:339 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) 388690 V1 Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008)..................................................................1, 3, 4, 5, 7, 8, 9, 12, 13, 16, 19 Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minn. 2009)...............................................................10 Sherman v. Stryker Corp., No. SACV 09-224, 2009 WL 2241664 (C.D. Cal. Mar. 30, 2009)...................21 Simmons v. Boston Scientific Corp., 2013 WL 1207421 (C.D. Cal. Mar. 25, 2013) ........................... 6, 11, 13, 14, 15 Thomsen v. Sacramento Metro. Fire Dist., No. 2:09-cv-01108, 2009 WL 8741960 (E.D. Cal. Oct. 20, 2009) ...................23 Tucker v. CBS Radio Stations, Inc., 194 Cal. App. 4th 1246, 124 Cal. Rptr. 3d 245 (2011) .....................................22 Valentine v. Baxter Healthcare Corp., 68 Cal. App. 4th 1467 (1999)...........................................................................21 Weaver v. Ethicon, Inc., No. 16cv257-GPC(BGS), 2016 WL 4430855 (S.D. Cal. Aug. 22, 2016) ...12, 13 Weaver v. Ethicon Inc., No. 16cv257-GPC(BGS), 2017 WL 680725 (S.D. Cal. Feb. 21, 2017)......13, 14 White v. Stryker Corp., 818 F. Supp. 2d 1032 (W.D. Ky. 2011)............................................................11 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. § 301 ......................................................................................................4 21 U.S.C. § 337 ......................................................................................................7 21 U.S.C § 351 ...............................................................................................11, 12 21 U.S.C. § 360 ........................................................................ 1, 3, 4, 5, 7, 8, 9, 11 Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 8 of 32 Page ID #:340 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) 388690 V1 Cal. Code Civ. Proc. 335.1....................................................................................18 OTHER AUTHORITIES 21 C.F.R. 820..................................................................................................11, 13 21 C.F.R. § 7.........................................................................................................11 Fed. R. Civ. P. 8.......................................................................................................2 Fed. R. Civ. P. 12 .....................................................................................................2 Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 9 of 32 Page ID #:341 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) 388690 V1 I. INTRODUCTION 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. (FAC ¶ 20.) The crux of plaintiffs’ claim is that defendants “falsely represented that the ICD would last for at least ten years,” but there was a defect in the device that caused “premature battery depletion.” (See, e.g., FAC ¶¶ 20, 22-24, 28, 56.) Plaintiffs allege causes of action for: (1) strict products liability for design defects; (2) strict products liability for manufacturing defects; (3) strict products liability failure to warn; (4) breach of implied warranties; (5) negligence; and (6) loss of consortium. Like their Original Complaint [Dkt. 1], federal law preempts Plaintiffs’ state- law claims related to the Model E102 ICD alleged in their FAC. The U.S. Food and Drug Administration (“FDA”) has classified Model E102 ICD as a Class III Medical Device, and evaluated it under that agency’s most rigorous premarket approval (“PMA”) process. Plaintiffs’ claims directly attack the Model E102 ICD, whose design, construction, manufacturing methods, testing, and labeling were specifically approved by the FDA pursuant to an equivalent of the PMA process. Plaintiffs’ claims are, therefore, preempted by the federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360k(a), as explained by the U.S. Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008). Only “parallel” claims survive preemption. Riegel, 552 U.S. at 330; Lowe v. Medtronic, Inc., No. CV-11-9551-R, 2012 WL 3656468, at *1 (C.D. Cal. May 9, 2012). Plaintiffs now title their claims as “parallel,” but there are no facts alleged to support any requirements specifically relating to the Model E102, let alone that any 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 express and/or implied preemption. Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 10 of 32 Page ID #:342 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) 388690 V1 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. There is no strict liability based on a design defect of a prescription medical device in California. The implied warranty claim fails due to lack of privity. 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 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. Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 11 of 32 Page ID #:343 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) 388690 V1 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 Plaintiffs’ claims are preempted because the device at issue was approved through the pre-market approval process. Federal law expressly preempts state-law claims concerning Class III devices approved through that process, and plaintiffs have not properly alleged any parallel claims. A. The Device At Issue Was Approved Through The Pre-Market Approval Process. Class III medical devices, such as the TELIGEN Model E102 ICD at issue in this case, are subject to an intensive FDA approval process - the Pre-Market Approval (“PMA”) process. In reviewing PMA applications, the FDA must “weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” 21 U.S.C. § 360c(a)(2)(C). After completing its review, the FDA may grant or deny approval. See 21 U.S.C. § 360e(d). If the FDA grants premarket approval to a medical device, a manufacturer may not make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness. 21 U.S.C. § 360e(d)(6)(A)(i). 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 Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 12 of 32 Page ID #:344 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) 388690 V1 (last updated January 9, 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. By passing the Medical Device Amendments of 1976, 21 U.S.C. § 360 (“MDA”),2 Congress ceded exclusive regulatory authority over medical devices to the FDA because it determined that satisfaction of the FDA’s PMA requirements are adequate, as a matter of law, to safeguard the American public in its use of medical devices. Congress further expressly preempted certain state-law regulations and common-law claims relating “to the safety or effectiveness of the device or to any other matter included in” a federal requirement. 21 U.S.C. § 360 (a). As the United States Supreme Court unequivocally declared in Riegel, the MDA expressly preempts state-law claims against Class III devices, like the Model E102 at issue here. Riegel, 552 U.S. at 321-23. Specifically, the Riegel Court held the FDA’s PMA process for Class III medical devices imposes device-specific federal requirements having a preemptive effect under the MDA. See id. at 321-23. Moreover, Riegel held that all common law tort claims relating to the “safety or effectiveness” of a PMA device are expressly preempted: “The MDA provides that no state ‘may establish or continue in effect with respect to a device . . . any requirement’ relating to safety or effectiveness that is different from, or in addition to, 2 The MDA were amendments to the FDCA, 21 U.S.C. § 301. Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 13 of 32 Page ID #:345 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) 388690 V1 federal requirements.” Riegel, 552 U.S. at 328 (emphasis added). The MDA also preempts any state-law claims seeking to impose requirements “different from, or in addition to” federal requirements. Id. at 325. In Riegel, the plaintiff sued Medtronic, Inc. after a Class III catheter ruptured in plaintiff’s coronary artery during surgery. Id. at 320. The plaintiff brought claims against Medtronic alleging that the catheter was designed, labeled, and manufactured in a manner that violated New York common law. Id. Medtronic defended on the ground that section 360k of the MDA preempted plaintiff’s common-law claims because those claims imposed duties on Medtronic that were “different from, or in addition to” the requirements imposed by the FDA on Medtronic’s catheter through the PMA process.3 The Supreme Court in Riegel left no doubt that the MDA expressly preempts state-law claims when the following two conditions exist: (1) Specific federal requirements apply to the particular medical device that is the subject of the state-law claim; and (2) the state-law tort claim imposes a standard of care or behavior that is “different from, or in addition to” the specific federal requirements. Id. at 321-23 (discussing Medtronic, Inc. v. Lohr, 518 U.S. 470, 498-99, 504-06, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (1996)). The Court concluded that “reference to a State’s ‘requirements’ includes its common-law duties” and, therefore, affirmed the district court’s determination that the MDA preempted plaintiff’s state-law claims for strict products liability, breach of implied warranty, and negligence in the design, testing, inspection, sale, and manufacture of the medical device. Id. at 324-25, 330. 3 Section 360k(a) of the MDA provides in pertinent part that: [N]o State or political subdivision of a State may establish or continue in effect with respect to any device intended for human use any requirement: (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety and effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 14 of 32 Page ID #:346 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) 388690 V1 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 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, predominantly design claims, in case involving cardiac defibrillator) (Selna, J.); Simmons v. Boston Scientific Corp., 2013 WL 1207421 (C.D. Cal. Mar. 25, 2013) (motion to dismiss granted against 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. Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 15 of 32 Page ID #:347 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) 388690 V1 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)). 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). Indeed, “when 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. Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 16 of 32 Page ID #:348 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) 388690 V1 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 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 FAC.) Indeed, nearly the same product liability allegations of premature battery depletion were found 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 Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 17 of 32 Page ID #:349 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) 388690 V1 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 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). Furthermore, to allege properly a parallel claim that survives preemption, plaintiffs must identify with particularity both a pre-existing state cause of action that is “substantially identical” to a pre-existing federal requirement that each 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 Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 18 of 32 Page ID #:350 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) 388690 V1 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 requirements must be “substantially identical”). Plaintiffs have not satisfied these requirements. 1. Plaintiffs Have Not Factually Substantiated a Violation of Federal Requirements Related to the Device at Issue. For claims involving Class III devices approved through the PMA process, like the device at issue here, it is plaintiffs’ burden to identify an existing specific federal requirement applicable to the device that affirmatively imposes a duty on the manufacturer that is “the same as” the duty that would be imposed by plaintiffs’ state law claim. See, e.g., In re Medtronic, Inc., Sprint Fidelis Prods. Liab. Litig., 592 F. Supp. 2d at 1158 (if a plaintiff fails to identify “any specific requirement,” then that plaintiff “necessarily seek[s] to impose requirements that differ from” those imposed by federal law); Riley v. Cordis Corp., 625 F. Supp. 2d 769, 776 (D. Minn. 2009) (“To escape preemption . . . a state law claim must be premised on the breach of a state-law duty that is the same as the duty imposed under the FDCA (or one of its implementing regulations)[.]”) (internal citation omitted). A failure to allege any violation of federal requirements cannot support parallel claims that survive preemption, and any such claims must be dismissed. See, e.g., Knoppel, 2013 WL 3803612, at *3 (granting preemption-based motion to dismiss involving claims against defibrillator for failure to allege federal violations); Nimtz v. Cepin, No. 08cv1294 L(AJB), 2011 WL 831182, at *4 (S.D. Cal. Mar. 3, 2011) (“Because plaintiff has not set forth that [defendant] failed to comply with the PMA process with respect to warnings and/or failing to manufacture or design the pacemaker in the manner required by the FDA’s regulations, he has not alleged that his strict liability claims are outside of preemption.”). Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 19 of 32 Page ID #:351 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) 388690 V1 Here, plaintiffs generally allege that the Subject ICD “was in violation of the FDCA, Manufacturing Guidelines, FDA Premarket Approval requirements, Reporting Requirements, Notification Requirements,” but the alleged “violations” are: (1) “concealing data from the FDA that premature battery depletion may cause the ICDs already implanted in patients to fail, in violation of 21 U.S.C. §§ 351 (e), (f), and (h)”; (2) failing to implement appropriate quality controls in its manufacturing process in violation of 21 C.F.R. 820; (3) failing to report adverse events associated with the ICDs, “as evidenced by the failure to report the failure Plaintiff’s Subject ICD and previous such failures . . . , in violation of 21 U.S.C. § 360i”; (4) “failing to implement effective recall communications to get the defective product out of the stream of commerce, in violation of 21 C.F.R. § 7, et seq., as evidenced by the fact [that] no notice was ever provided to Plaintiff . . . .” (See, e.g., FAC ¶ 35.) These allegations are insufficient to survive preemption. a. The Allegations Regarding the General Provision for an “Adulterated” Device Do Not Support a Parallel Claim that Survives Preemption. Plaintiffs amended their complaint to allege Boston Scientific committed fraud on the FDA by “concealing data from the FDA that premature battery depletion may cause the ICDs already implanted in patients to fail,” which plaintiffs allege violates the definition for an “adulterated” device under 21 U.S.C. §§ 351 (e), (f). (FAC ¶¶ 35, 57, 75.) This claim fails on multiple grounds. First, plaintiffs cite to the general regulations for an adulterated device, but do not allege how Boston Scientific purportedly violated the regulation. See Simmons v. Boston Scientific Corp., No. CV 12-7962 PA (FFMx), 2013 WL 1207421, at *4 (C.D. Cal. Mar. 25, 2013) (“a plaintiff cannot simply incant the magic words ‘[defendant] Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 20 of 32 Page ID #:352 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) 388690 V1 violated FDA regulations’ in order to avoid preemption”) (internal quotations and citations omitted). Plaintiffs must, at minimum, state how the alleged defect deviated from a federal standard or procedure. White v. Stryker Corp., 818 F. Supp. 2d 1032, 1033 (W.D. Ky. 2011) (granting preemption-based motion to dismiss all claims); see also Weaver v. Ethicon, Inc., No. 16cv257-GPC(BGS), 2016 WL 4430855, at *5 (S.D. Cal. Aug. 22, 2016) (granting motion to dismiss because “the amended complaint makes no allegations concerning any violations of federal law, including violations of the FDA or any requirements related to the [Class III device] and does not allege a causal nexus between the violation and the injury”). Plaintiffs do not identify any particular information that Boston Scientific purportedly “concealed information from the FDA.” Nor do plaintiffs allege how any conduct violated any particular provision. Plaintiffs cite to 21 U.S.C § 351 (e), but this subdivision governs devices not in conformity with performance standards, not purportedly concealing information from the FDA. Plaintiffs have not identified any particular performance standards applicable to the device that were violated, let alone alleged such violations caused plaintiffs’ injuries. Plaintiffs also cite to subdivision (f), which includes general provisions regarding Class III devices. As set forth, supra, Section III.A, the Subject Device is and always has been a Class III device-the original and supplemental PMA approvals remain in effect and have never been suspended or revoked. Plaintiffs’ generic pleading in this case is insufficient to state a parallel claim under Riegel. Second, even assuming, arguendo, this claim survived express preemption, it is impliedly preempted. Plaintiffs’ claim that Boston Scientific “concealed information from the FDA” is equivalent to the “fraud-on-the-FDA” claims that were found to be impliedly preempted in Buckman, 531 U.S. at 348, and Perez, 711 F.3d at 1119-20. Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 21 of 32 Page ID #:353 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) 388690 V1 b. The Allegations Regarding General Guidelines for Quality Control Measures Do Not Support a Parallel Claim that Survives Preemption. Plaintiffs also baldly assert that Boston Scientific did not implement quality controls in its manufacturing process in violation of 21 C.F.R. 820. (See, e.g. FAC ¶ 35; see also FAC ¶¶ 21, 29-30.) This claim also fails, however, because plaintiffs neither identify how Boston Scientific purportedly deviated from a particular federal standard, nor how any such violation caused the alleged injuries. Simmons, 2013 WL 1207421, at *4; see also Riegel, 552 U.S. at 322-23 (“Unlike general labeling duties, premarket approval is specific to individual devices.”); Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 588 (E.D.N.Y. Dec. 28, 2009) (holding guidelines such ase Current Good Manufacturing Practices ‘“are simply too generic, standing alone, to serve as the basis”’ for parallel claims that survive preemption). Plaintiffs’ conclusory allegations fall short of claims that were recently dismissed with prejudice in Weaver v. Ethicon Inc., No. 16cv257-GPC(BGS), 2017 WL 680725, at * 6 (S.D. Cal. Feb. 21, 2017). In Weaver, plaintiffs generally alleged violation of 21 C.F.R. § 820 et seq., including not implementing quality control measures specifically required by the FDA. Id. The court found the allegations regarding violations of federal regulations were conclusory, and there were no facts that these violations caused the plaintiff’s injuries. Id. Here, plaintiffs have not alleged any facts regarding any particular quality controls that Boston Scientific was specifically required by the FDA to implement. Nor have they alleged how such quality controls purportedly caused the battery depletion that ultimately lead to plaintiffs’ claimed injuries. This claim thus also fails. Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 22 of 32 Page ID #:354 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) 388690 V1 c. The Allegations Regarding Failure to Report Adverse Events Do Not Support a Parallel Claim that Survives Preemption. Plaintiffs next assert that Boston Scientific “fail[ed] to report adverse events associated with the ICDs including the Subject ICD models.” (See, e.g., FAC ¶ 35.) But the only alleged adverse event plaintiffs allege Boston Scientific failed to report is plaintiffs’ alleged injury. Even assuming, arguendo, that this allegation as true, failing to notify the FDA of a plaintiff’s injury could have no causal relationship to the injury she suffered. 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 FAC ¶ 27), 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, as opposed to the FDA. (See FAC ¶ 27.) 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. Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 23 of 32 Page ID #:355 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) 388690 V1 d. The Allegations Regarding Post-Recall Communications Do Not Support a Parallel Claim that Survives Preemption. Finally, plaintiffs assert Boston Scientific failed to implement effective recall communications. 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 v. Boston Scientific Corp., No. CV 12- 7962 PA (FFMx), 2013 WL 1207421, at *4 (C.D. Cal. Mar. 25, 2013) (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)). Moreover, 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 C to Request for Judicial Notice, filed concurrently herewith). Plaintiffs generally allege some sort of wrongdoing based on the recall. (See FAC ¶¶ 22-24, 54, 68-69.) The FDA’s publicly-available and judicially noticeable website Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 24 of 32 Page ID #:356 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) 388690 V1 lists the FDAs “Determined Cause” of the low voltage capacitor issue as a design issue. (FAC ¶ 24; RJN, Ex. D [FDA Public Information on LV Capacitor Advisory].) 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. 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 addition, plaintiffs have not identified any particular federal requirements mandating Boston Scientific to notify plaintiffs directly. (See, e.g., FAC ¶¶34-35.) On the contrary, 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).) Plaintiffs are seeking to add an additional requirement than the FDA’s advisory, so plaintiffs’ claims are expressly preempted. e. The Breach of Implied Warranty and Negligence Claims Do Not Include Any Parallel Claim Allegations. Plaintiffs’ fourth cause of action for breach of implied warranties and fifth cause of action for negligence merely changed their label of the cause of action so that it purports to be a “parallel” claims. Plaintiffs do not even attempt to allege any specific allegations to support such claims. These claims should be dismissed. Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 25 of 32 Page ID #:357 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) 388690 V1 2. Plaintiffs Cannot Allege A Causal Nexus Between A Federal Violation and Their Alleged Injuries. Because plaintiffs have not alleged that Boston Scientific deviated from any specific federal requirements, the FAC does not and cannot specify a causal connection between their alleged injuries and a federal violation. Cohen v. Guidant Corp., 2011 WL 637472, at *1 (holding that to properly allege parallel claims that escape 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.”) (citing Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 1301-02 (D. Colo. 2008); Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 282 (E.D.N.Y.2009)). Even if plaintiffs here had alleged facts sufficient to substantiate a violation of federal requirements relating to the device at issue, which they have not, they would still be required to allege facts showing a causal connection between such violation and their alleged injuries. See Lowe, 2012 WL 3656468, at *1 (“[A] plaintiff must allege facts . . . establishing a causal nexus between the alleged injury and the violation.”) (citing Cohen, 2011 WL 637472, at*1). Here, plaintiffs have made no allegations that Boston Scientific deviated from FDA requirements, much less any allegations supporting an association between federal violations and the alleged “battery depletion” in Mr. Paturzo’s specific Model E102 ICD. Consequently, they cannot specify a causal connection between their alleged injuries and such alleged federal violations. See Erickson, 846 F. Supp. 2d at 1093 (noting that “[p]laintiff fails to allege how Defendants deviated from any specific FDA requirements, or how these violations affect the [devices] at issue,” plaintiff failed “to establish a parallel claim defeating MDA preemption”) (emphasis added); Cohen, 2011 WL 637472, at *2 (noting that “[p]laintiff has not provided any factual support in his Complaint . . . that a defect occurred as a result of Defendant’s Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 26 of 32 Page ID #:358 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) 388690 V1 violation of FDA regulations related to his device.”) (emphasis added). Therefore, all of plaintiffs’ claims should be dismissed. 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 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 Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 27 of 32 Page ID #:359 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) 388690 V1 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 can not 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 (FAC ¶ 20), plaintiffs also allege defendants falsely represented that a Guidant Model T135, Serial Number 943073 ICD, would also last for ten years. (FAC ¶ 19.) 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. 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. (FAC ¶¶ 19-20.) “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. Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 28 of 32 Page ID #:360 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) 388690 V1 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.” (FAC ¶ 68(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, 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.4 V. PLAINTIFFS’ CLAIMS FAIL ON ADDITIONAL GROUNDS A. Plaintiffs’ Strict Liability For Design Defect Claim Fails As A Matter Of California Law. It is well established under California law that there is no strict liability for design defect. Brown v. Superior Court, 44 Cal. 3d 1049, 1061, 245 Cal. Rptr. 412 (1988) (concluding a drug manufacturer’s liability for a defectively designed drug should not be measured by the standards of strict liability). This policy is extended to 4 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 21 Filed 03/15/17 Page 29 of 32 Page ID #:361 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) 388690 V1 medical devices and reflects the public policy that strict liability for design defect would potentially subject a manufacturer to liability for flaws in their products that they have not, and could not have, discovered. See Hufft v. Horowitz, 4 Cal. App. 4th 8, 19 (1992) (“[t]he Brown court observed that even though a medical product with dangerous side effects may fairly be ‘characterized’ as defectively designed, strict liability should apply only if it would serve the public interest. We believe the public’s interest in development, availability and affordability of medical devices demands rejection of strict liability.”) (internal citation omitted). Therefore, plaintiffs’ first cause of action for strict products liability for design defect fails as a matter of law and should be dismissed without leave to amend. B. Plaintiffs’ Breach of Implied Warranty Claim Fails As A Matter Of California Law. The Court should dismiss plaintiffs’ cause of action for breach of implied warranty 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). Therefore, any implied warranty, assuming there is one, must be evaluated by a physician. It is the physician who reviews the warnings and selects particular devices at issue here to implant, and thus determines whether the proposed application is fit for ordinary purposes for which such devices are used. It is also the physician’s skill or judgment that matters in determining which device should be implanted for each Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 30 of 32 Page ID #:362 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) 388690 V1 patient based on their unique needs. The fact that it is the physician to whom warnings are made is important for warranty claims because the transaction is with the physician, not the patient, and it is the physician’s skill and judgment that matter. Accordingly, 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). As in Blanco, there is no reason to believe Mr. Paturzo relied on the manufacturer’s representations that the specific Model E102 ICD was appropriate for him. Rather, he likely relied on his physician’s skill and judgment in choosing the device as a part of the course of treatment. Blanco, 158 Cal. App. 4th at 1058-59. Such devices are only sold to licensed physicians and hospitals, therefore, there is no decision-making process by the consumer at the point of purchase that could lead to breach of warranty. Because it is the physician who selects the product, any privity is between the seller and the physician. Accordingly, plaintiffs’ causes of action for breach of implied warranty should be dismissed without leave to amend. Id. at 1058. C. The Loss Of Consortium Claim Is Derivative Of The Other Claims So Fails For The Same Reasons. In California, if no cause of action is stated against the injured party, his or her spouse has no cause of action for loss of consortium. See Tucker v. CBS Radio Stations, Inc., 194 Cal. App. 4th 1246, 1256, 124 Cal. Rptr. 3d 245 (2011) (citations omitted). Here, Nan Paturzo’s loss of consortium claim is based Peter Paturzo’s alleged injuries. (FAC ¶¶ 98-102.) As a result, it should be dismissed because it is derivative of the above-listed claims against defendant, and should fail for the same reasons. See Hickman v. Sofamor-Danek Group, Inc., No. C 95-01095, 1999 WL 606690, 1999 U.S. Dist. LEXIS 4384, at * 4 (N.D. Cal. Feb. 17, 1999) (granting summary judgment in favor of defendants on claims for strict products liability, Case 8:16-cv-02174-JLS-KES Document 21 Filed 03/15/17 Page 31 of 32 Page ID #:363 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) 388690 V1 breach of warranty, and negligence, and dismissing the claim for loss of consortium because it was derivative of the plaintiffs’ other claims); see also Thomsen v. Sacramento Metro. Fire Dist., No. 2:09-cv-01108, 2009 WL 8741960, at *13 (E.D. Cal. Oct. 20, 2009) (dismissing derivative loss of consortium claim because the court granted the defendant’s motion to dismiss with respect to all of the underlying causes of action upon which the loss of consortium claim was based). VI. CONCLUSION For the foregoing reasons, Boston Scientific respectfully requests the Court grant the motion to dismiss plaintiffs’ first amended complaint, and each of the causes of action alleged therein, without leave to amend. Dated: March 15, 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 21 Filed 03/15/17 Page 32 of 32 Page ID #:364 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 REQUEST FOR JUDICIAL NOTICE 8:16-cv-2174 JLS (KESx) 388691 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) DEFENDANTS BOSTON SCIENTIFIC CORPORATION AND GUIDANT LLC’S REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS Date: April 21, 2017 Time: 2:30 p.m. Dept.: 10A [Filed concurrently with Motion; Declaration of Brian Ziska; [Proposed] Order] Complaint Filed: August 16, 2016 First Am. Compl. Filed: February 13, 2017 Pursuant to Rule 201 of the Federal Rules of Evidence, defendants Boston Scientific Corporation and Guidant LLC (collectively “Boston Scientific”) respectfully request the Court to take judicial notice of the following documents and facts in connection with, and in support of, their Motion to Dismiss: Case 8:16-cv-02174-JLS-KES Document 21-1 Filed 03/15/17 Page 1 of 38 Page ID #:365 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 REQUEST FOR JUDICIAL NOTICE 8:16-CV-2174 JLS (KESx) 388691 V1 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) (Attached as Exhibit A); B. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P9 60040 (last updated March 13, 2017) (listing links to the original approval letter and all applicable supplements, including Supplement No. S155 [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) (Attached as Exhibit B); C. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfpma/pma.cfm?id=P960040S155 (listing the May 8, 2008 supplemental PMA approval for the TELIGEN Model E102 at issue) (Attached as Exhibit C); D. 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=1216 16 (Oct. 17, 2013) (Attached as Exhibit D); and E. The search results for Model E102 prior to January 29, 2010, on the Food and Drug Administration’s Manufacturer and User Facility Device Experience Database, available to be searched at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/TextSearch.cf m (last updated February 28, 2017) (Attached as Exhibit E). Funke v. Sorin Group USA, Inc., 147 F. Supp. 3d 1017, 1025 (C.D. Cal. 2015). The court may take judicial notice of information in government documents or from a government website when the fact “is not subject to reasonable dispute because it can accurately and readily be determined from sources whose accuracy cannot Case 8:16-cv-02174-JLS-KES Document 21-1 Filed 03/15/17 Page 2 of 38 Page ID #:366 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 REQUEST FOR JUDICIAL NOTICE 8:16-CV-2174 JLS (KESx) 388691 V1 reasonably be questioned.” Fed. R. Evid. 201; Daniels-Hall v. Nat’l Educ. Ass’n, 629 F.3d 992, 998-99 (9th Cir. 2010). Certain public records-including those of the FDA-are entitled to judicial notice without converting a motion to dismiss into one for summary judgment. See, e.g., Funke v. Sorin Group USA, Inc., 147 F. Supp. 3d 1017, 1025 (C.D. Cal. 2015) (granting request for judicial notice of list of adverse event reports pertaining to a device in the FDA’s online MAUDE database); Weaver v. Ethicon, Inc., No. 16cv257-GPC(BGS), 2016 WL 4430855, at *2 n. 1 (S.D. Cal. Aug. 22, 2016) (granting requests for judicial notice of documents concerning the FDA’s premarket approval); Frere v. Medtronic, Inc., No. EDCV 15-02338-BRO (DTBx), 2016 WL 1533524, at *3-4 (C.D. Cal. April 6, 2016) (granting requests for judicial notice of documents concerning the FDA’s premarket approval and recall notices referenced in the complaint); Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085, 1089 (C.D. Cal. 2011) (Guilford, J.) (taking judicial notice of PMA approvals listed in the Federal Register and on the FDA’s online database); In re Amgen Inc. Sec. Litig., 544 F. Supp. 2d 1009, 1023 (C.D. Cal. 2008) (granting requests for judicial notice of information posted on the FDA’s website). Indeed, under federal law, courts are required to take judicial notice of the original PMA approvals, which are reflected in the Federal Register. See 44 U.S.C. § 1507 (“[t]he contents of the Federal Register shall be judicially noticed.”); 21 C.F.R. § 814.44(d)(1) (2010) (“FDA will publish in the Federal Register after each quarter a list of the approvals announced in that quarter.”). Dated: March 15, 2017 Respectfully submitted, SHOOK, HARDY & BACON L.L.P. By: /s/ Brian Ziska Brian Ziska Attorney for Defendants Boston Scientific Corporation and Guidant LLC Case 8:16-cv-02174-JLS-KES Document 21-1 Filed 03/15/17 Page 3 of 38 Page ID #:367 Exhibit A Case 8:16-cv-02174-JLS-KES Document 21-1 Filed 03/15/17 Page 4 of 38 Page ID #:368 • LexisNexis FEDERAL REGISTER Vol. 63, No. 17 Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) [Docket No. 98M-0038] Guidant Corp.; Premarket Approval of VENTAK (R) AV AICD Model 1810/Model 1815 Automatic Implantable Cardioverter Defibrillator (AICD) with the Model 2833 Software Application 63 FR 3905 DATE: Tuesday, January 27, 1998 ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing its approval of the application by Guidant Corp., St. Paul, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the VENTAK (R) AV AICD System. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of July 18, 1997, of the approval of the application. DATES: Petitions for administrative review by February 26, 1998. ADDRESSES: Written requests for copies of the summary of safety and effectiveness data and petitions for administrative review to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Carole C. Carey, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8609. SUPPLEMENTARY INFORMATION: On August 20, 1996, Guidant Corp., St. Paul, MN 55112-5798, submitted to CDRH an application for premarket approval of VENTAK (R) AV AICD Model 1810/Model 1815 Automatic Implantable Cardioverter Defibrillator (AICD) with the Model 2833 Software Application which Page 1 f™‰ŠƒŠ• b QQU Case 8:16-cv-02174-JLS-KES Document 21-1 Filed 03/15/17 Page 5 of 38 Page ID #:369 consists of the following: Model 1810/Model 1815 pulse generator and Model 2833 Software Application to be used with commercially available Cardiac Pacemakers, Inc., Programmer/Recorder/Monitor (PRM). The device is a multiprogrammable automatic, implantable dual-chamber pacemaker and cardioverter defibrillator, and is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced one of the following situations: (1) Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia; (2) recurrent, poorly tolerated sustained ventricular tachycardia (VT); (3) prior myocardial infarction, left ventricular ejection fraction of > 35 percent, and a documented episode of nonsustained VT, with an inducible ventricular tachyarrhythmia. Patients suppressible with IV procainamide or an equivalent antiarrhythmic have not been studied. NOTE: The clinical outcome of hemodynamically stable, sustained-VT patients is not fully known. Safety and effectiveness studies have not been conducted. The VENTAK (R) AV AICD pulse generator is not intended for use solely as a primary bradycardia support device. In accordance with the provisions of section 515(c)(2) of the act (21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of 1990, this premarket approval application (PMA) was not referred to the Circulatory System Devices Panel of the Medical Devices Advisory Committee, an FDA advisory committee, for review and recommendation because the information in the PMA substantially duplicates information previously reviewed by this panel. On July 18, 1997, CDRH approved the application by a letter to the applicant from the Director of the Office of Device Evaluation, CDRH. A summary of the safety and effectiveness data on which CDRH based its approval is on file in the Dockets Management Branch (address above) and is available from that office upon written request. Requests should be identified with the name of the device and the docket number found in brackets in the heading of this document. Opportunity for Administrative Review Section 515(d)(3) of the act authorizes any interested person to petition, under section 515(g) of the act, for administrative review of CDRH's decision to approve this application. A petitioner may request either a formal hearing under 21 CFR part 12 of FDA's administrative practices and procedures regulations or a review of the application and CDRH's action by an independent advisory committee of experts. A petition is to be in the form of a petition for reconsideration under 21 CFR 10.33(b). A petitioner shall identify the form of review requested (hearing or independent advisory committee) and shall submit with the petition supporting data and information showing that there is a genuine and substantial issue of material fact for resolution through administrative review. After reviewing the petition, FDA will decide whether to grant or deny the petition and will publish a notice of its decision in the Federal Register. If FDA grants the petition, the notice will state the issue to be reviewed, the form of the review to be used, the persons who may participate in the review, the time and place where the review will occur, and other details. Petitioners may, at any time on or before February 26, 1998, file with the Dockets Management Branch (address above) two copies of each petition and supporting data and information, identified with the name of the device and the docket number found in brackets in the heading of this document. Received petitions may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. This notice is issued under the Federal Food, Drug, and Cosmetic Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the Director, Center for Devices and Radiological Health (21 CFR 5.53). Dated: January 5, 1998. Joseph A. Levitt, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. 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(_Q^W]`_(QR^V(QTR\Q_(QTH`O[RO^R_(_SO^QV'QTZ */' (_Q^W]`_(QR^V(QTR\Q_(QT8(QYO__WTWQO`W\['QTZ *1' (_Q^W]`_(QR^V(QTR\Q_(QT6__SZ(O__SZPYS '̂QTZ *2' (_Q^W]`_(QR^V(QTR\Q_(BSR_a[(_SO^QVGS]\^`ISd`'QTZ +)' (_Q^W]`_(QR^V(QTR\Q_(QT8YWO(HSO^QV'QTZ +*' (_Q^W]`_(QR^V(QTR\Q_(QTIEA8(`]YQ'QTZ ++' (_Q^W]`_(QR^V(QTR\Q_(_SO^QV(RSTOaY`'QTZ5<6F4`^aS f™‰ŠƒŠ• f QTT Case 8:16-cv-02174-JLS-KES Document 21-1 Filed 03/15/17 Page 38 of 38 Page ID #:402 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) 388692 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: April 21, 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 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 21-2 Filed 03/15/17 Page 1 of 2 Page ID #:403 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) 388692 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. On March 8, 2017, I called counsel of record for plaintiffs, Jay F. Stocker, to meet and confer regarding Boston Scientific’s anticipated motion to dismiss, as required by Local Rule 7-3. Mr. Stocker was not available, so I left a voicemail outlining the issues to be raised in the anticipated motion to dismiss, including the issue of preemption, and requesting a further meet and confer. On March 14, 2017, I called Mr. Stocker to further discuss the anticipated motion to dismiss, but Mr. Stocker was not available so I left another voicemail regarding the substance of the contemplated motion. On March 15, 2017, I had a further telephonic exchanges with Mr. Stocker regarding the motion to dismiss. The parties were unable to reach a resolution, thus necessitating the filing of the present motion. I declare under penalty of perjury that the foregoing statements are true and correct. Executed this 15th day of March, 2017 in Irvine, California. /s/ Brian P. Ziska Brian P. Ziska Case 8:16-cv-02174-JLS-KES Document 21-2 Filed 03/15/17 Page 2 of 2 Page ID #:404 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) 388693 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: April 21, 2017 Time: 2:30 p.m. Dept.: 10A The motion of defendant Boston Scientific Corporation for dismissal of the second cause of action for product liability 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 21-3 Filed 03/15/17 Page 1 of 2 Page ID #:405 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) 388693 V1 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. 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). 2. Plaintiffs’ claims are barred by the statute of limitations. Cal. Civ. Proc. Code § 335.1. 3. The first cause of action for strict liability for design defects is precluded because there is no strict liability for design defect of a medical device under California law. Brown v. Superior Court 44 Cal.3d 1049, 1061-66 (1988); Hufft v. Horowitz, 4 Cal.App.4th 8, 19, 5 Cal. Rptr. 2d 377 (1992). 4. The complaint fails to state a claim for breach of implied warranty because plaintiffs do not allege they were in privity with BSC or relied on its skill and judgment in deciding to use the mesh device. See Blanco v. Baxter Healthcare, 158 Cal. App. 4th 1039 (2008). 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 21-3 Filed 03/15/17 Page 2 of 2 Page ID #:406