Paul Wall v. Davol, Inc. et al

NOTICE OF MOTION AND MOTION to Dismiss Case as to the First Amended Complaint

C.D. Cal.December 1, 2016

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 AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e Michael K. Brown (SBN 104252) Email: mkbrown@reedsmith.com Marilyn A. Moberg (SBN 126895) Email: mmoberg@reedsmith.com Michelle L. Cheng (SBN 239711) Email: mcheng@reedsmith.com Reed Smith LLP 355 South Grand Avenue Suite 2900 Los Angeles, CA 90071-1514 Telephone: +1 213 457 8000 Facsimile: +1 213 457 8080 Attorneys for Defendants Davol Inc., Bard Devices, Inc. and C.R. Bard, Inc. UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA PAUL WALL, Plaintiff, vs. DAVOL INC.; BARD DEVICES, INC.; C.R. BARD; and DOES 1-10, inclusive, Defendants. Case No. 5:16-CV-01761-JGB(KKx) DEFENDANTS DAVOL INC., BARD DEVICES, INC. AND C.R. BARD, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT Complaint Filed: August 17, 2016 FAC Filed: November 10, 2016 Hearing Date: February 27, 2017 Time: 9:00 a.m. Courtroom: 1 Honorable Jesus G. Bernal [Concurrently Filed With Memorandum of Points and Authorities and [Proposed] Order] Case 5:16-cv-01761-JGB-KK Document 21 Filed 12/01/16 Page 1 of 3 Page ID #:106 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 AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on February 27, 2017, at 9:00 a.m., or as soon as the matter can be heard in Courtroom 1 of the United States District Court for the Central District of California, Riverside, located at 3470 Twelfth St., Riverside, CA 92501, Defendants Davol Inc., Bard Devices, Inc. and C. R. Bard, Inc. will and hereby do move the Court for an order granting a Motion to Dismiss the First Amended Complaint filed by Plaintiff Paul Wall pursuant to Federal Rules of Civil Procedure, Rule 12(b)(6), for failure to state any claims upon which relief can be granted. Defendants’ Motion to Dismiss is made on the grounds that Plaintiff has failed to fail to state a claim for relief “that is plausible on its face,” as required under Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009) and Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007), as follows: Plaintiff’s First Cause of Action for Negligence is insufficient because Plaintiff has not identified any manufacturing defect or inadequate warning about the CK Patch that is due to Defendants’ negligence. Further, to the extent that Plaintiff’s theory of negligence is premised on a purported “fraud on the FDA” or federal requirements, the claim cannot proceed under federal and California law. Plaintiff’s Second Cause of Action for Strict Products Liability - Manufacturing Defect fails because Plaintiff appears to be asserting a design-defect claim under the guise of a manufacturing defect. In spite of this Court’s guidance in another action involving the CK Patch, Plaintiff is unable to identify any particular manufacturing defect that “make[s] clear how [the plaintiff’s] patch differed from the intended design or from seemingly identical models.” Jager v. Davol, Inc., Case No. 16-1424JGB (KKx), 2016 WL 6157942, at *4 (C.D. Cal. Oct. 20, 2016). This claim should be dismissed without leave to amend. Plaintiff’s Third Cause of Action for Strict Liability - Inadequate Warning fails because Plaintiff cannot establish that the Defendants knew or should have known of Case 5:16-cv-01761-JGB-KK Document 21 Filed 12/01/16 Page 2 of 3 Page ID #:107 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 AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e the purported dangers relating to the CK Patch at the time the device was manufactured or distributed that could have altered Plaintiff’s surgeon’s decision to implant it. This claim should be dismissed. Plaintiff’s Fourth Cause of Action for Negligent Misrepresentation fails because he does not identify a single affirmative misrepresentation that the Defendants made either to Plaintiff or to Plaintiff’s implanting surgeon - a requirement that the Court outlined in Jager. Id., *5. Rather, Plaintiff’s allegations are that Defendants omitted certain information to Plaintiff’s doctor both before and after the August 2004 CK Patch implant surgery, but this is not enough to state a cause of action for negligent misrepresentation. Finally, Plaintiff’s Punitive Damages demand should be dismissed because the amended allegations make clear that the pleadings are insufficient to establish that any of the corporate Defendants acted with malice, oppression or fraud pursuant to California Civil Code Section 3294. Pursuant to Local Rule 7-3, on November 17 and 28, 2016, counsel met and conferred regarding this motion. This Motion is based on this Notice; the attached Memorandum of Points and Authorities in Support of the Motion to Dismiss; all papers filed in support of Defendants’ Motion; and any further argument that may be presented at the hearing on this matter. Dated: December 1, 2016 REED SMITH LLP By /s/ Michelle L. Cheng Michael K. Brown Marilyn A. Moberg Michelle L. Cheng Attorneys for Defendants Davol Inc., Bard Devices, Inc. and C. R. Bard, Inc. Case 5:16-cv-01761-JGB-KK Document 21 Filed 12/01/16 Page 3 of 3 Page ID #:108 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e Michael K. Brown (SBN 104252) Email: mkbrown@reedsmith.com Marilyn A. Moberg (SBN 126895) Email: mmoberg@reedsmith.com Michelle L. Cheng (SBN 239711) Email: mcheng@reedsmith.com Reed Smith LLP 355 South Grand Avenue Suite 2900 Los Angeles, CA 90071-1514 Telephone: +1 213 457 8000 Facsimile: +1 213 457 8080 Attorneys for Defendants Davol Inc., Bard Devices, Inc. and C.R. Bard, Inc. UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA PAUL WALL, Plaintiff, vs. DAVOL INC.; BARD DEVICES, INC.; C.R. BARD; and DOES 1-10, inclusive, Defendants. Case No. 5:16-CV-01761-JGB(KKx) DEFENDANTS DAVOL INC., BARD DEVICES, INC. AND C.R. BARD, INC.’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT Complaint Filed: August 17, 2016 FAC Filed: November 10, 2016 Hearing Date: February 27, 2017 Time: 9:00 a.m. Courtroom: 1 Honorable Jesus G. Bernal [Concurrently Filed With Notice of Motion and Motion and [Proposed] Order] Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 1 of 21 Page ID #:109 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 - i - DEFENDANTS’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e TABLE OF CONTENTS Page I. INTRODUCTION ................................................................................................ 1 II. ALLEGATIONS IN THE COMPLAINT ............................................................ 2 III. LEGAL STANDARD .......................................................................................... 3 IV. ARGUMENT........................................................................................................ 4 A. Plaintiff’s Negligence Claim (First Cause of Action) Fails Because Plaintiff Cannot and Has Not Established That The CK Patch Exhibited A Defect Due To Defendants’ Negligence ...................... 4 B. Plaintiff’s Strict Liability-Manufacturing Defect Claim (Second Cause of Action) Still Fails To Identify The Manufacturing Defect That His CK Patch Exhibited ......................................................... 7 C. Plaintiff Is Unable To State A Claim For Strict Liability- Inadequate Warning (Third Cause of Action) ........................................... 9 D. Plaintiff’s Negligent Misrepresentation Claim (Fourth Cause of Action) Still Fails To Identify Any Affirmative Misrepresentations That Plaintiff Or His Surgeon Relied Upon To Their Detriment .................................................................................. 11 E. Plaintiff’s Claim For Punitive Damages Should Be Dismissed .............. 13 V. CONCLUSION .................................................................................................. 16 Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 2 of 21 Page ID #:110 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e TABLE OF AUTHORITIES Page(s) Cases Ashcroft v. Iqbal, 556 U.S. 662 (2009)..................................................................................... 1, 3, 9, 11 Barker v. Lull Eng’g Co., 20 Cal. 3d 413 (1978) ................................................................................................ 5 Barrett v. Atlas Powder Co., 86 Cal. App. 3d 560 (1978) ....................................................................................... 8 Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007).......................................................................................... passim Brousseau v. Jarrett, 73 Cal. App. 3d 864 (1977) ..................................................................................... 14 Brown v. Superior Court, 44 Cal. 3d 1049 (1988) .............................................................................................. 9 Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001)................................................................................................... 6 Carlin v. Superior Court, 13 Cal. 4th 1104 (1996) ............................................................................................. 9 Christensen v. Synthes USA, No. CIV 11-10369-GHK, 2013 WL 1899094 (C.D. Cal. May 6, 2013) .................. 4 Coleman v. Medtronic, Inc., 223 Cal. App. 4th 413 (2014) .................................................................................... 6 Das v. Bank of Am., N.A., 186 Cal. App. 4th 727 (2010) .................................................................................... 7 Dilley v. C.R. Bard, Inc., 2:14-cv-01795-ODW (ASx), 2014 WL 1338877 (C.D. Cal. Apr. 3, 2014) .................................................................................................................. 10, 12 Erickson v. Boston Sci. Corp., 846 F. Supp. 2d 1085 (C.D. Cal. 2011) ..................................................................... 3 Ferguson v. Lieff, Cabraser, Heimann & Bernstein, 30 Cal. 4th 1037 (2003) ........................................................................................... 14 Fontalvo ex rel. Fontalvo v. Sikorsky Aircraft Corp., No. 13-cv-0331-GPC-KSC, 2013 WL 4401437 (S.D. Cal. Aug. 15, 2013) .......................................................................................................................... 4 Food Pro Int’l, Inc. v. Farmers Ins. Exch., 169 Cal. App. 4th 976 (2008) .................................................................................. 14 Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 3 of 21 Page ID #:111 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e GBTI, Inc. v. Ins. Co. of Pa., No. CV F 09-1173 LJO DLB, 2009 WL 2365409 (E.D. Cal. July 29, 2009) ........................................................................................................................ 15 Granger v. Lowe’s Home Ctrs., LLC, No. 1:14-CV-01212-KJM-SKO, 2014 WL 4976134 (E.D. Cal. Oct. 3, 2014) ........................................................................................................................ 14 Huntman v. Danek Med., Inc., No. 97-2155-IEG RBB, 1998 WL 663362 (S.D. Cal. July 24, 1998) ................... 10 Jager v. Davol, Inc., Case No. 16-1424JGB, 2016 WL 6157942 (C.D. Cal. Oct. 20, 2016) ............ passim Kelley v. Corr. Corp. of Am., 750 F. Supp. 2d 1132 (E.D. Cal. 2010) ................................................................... 14 Knoppel v. St. Jude Med. Inc., No. SACV 13-383 JVS (ANx), 2013 WL 3803612 (C.D. Cal. May 7, 2013) .......................................................................................................................... 4 Merrill v. Navegar, Inc., 26 Cal. 4th 465 (2001) ............................................................................................... 4 Motus v. Pfizer Inc. (Roerig Div.), 358 F.3d 659 (9th Cir. 2004) ..................................................................................... 6 Nimtz v. Cepin, Civ. No. 08cv1294 L(AJB), 2011 WL 831182 (S.D. Cal. Mar. 3, 2011) .......................................................................................................................... 5 Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013) ................................................................................... 6 Peterson v. Allstate Indem. Co., 281 F.R.D. 413 (C.D. Cal. 2012) ............................................................................. 11 Plenger v. Alza Corp., 11 Cal. App. 4th 349 (1992) ...................................................................................... 9 Rhynes v. Stryker Corp., No. 10-5619 SC, 2011 WL 2149095 (N.D. Cal. May 31, 2011) .............................. 8 Schwartz v. Wright Med. Tech., Inc., No. EDCV-1401615-JGB(SPX), 2014 WL 11320637 (C.D. Cal. Sept. 11, 2014) .................................................................................................................... 7 Sprewell v. Golden State Warriors, 266 F.3d 979 (9th Cir. 2001) ................................................................................... 12 Steckman v. Hart Brewing Inc., 143 F.3d 1293 (9th Cir. 1998) ................................................................................. 12 Tapia v. Davol, Inc., No. 15cv179-GPC JLB, 2015 WL 6828660 (S.D. Cal. Nov. 6, 2015) ................... 15 Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 4 of 21 Page ID #:112 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e Taragan v. Nissan N. Am., Inc., No. C 09-3660 SBA, 2013 WL 3157918 (N.D. Cal. June 20, 2013) ....................... 8 In re Toyota Unintended Acceleration Mktg., Sales Practices, and Prods. Liab. Litig., 754 F. Supp. 2d 1208 (C.D. Cal. 2010) ..................................................................... 8 Whittlestone, Inc. v. Handi-Craft Co., 618 F.3d 970 (9th Cir. 2010) ................................................................................... 13 Statutes 21 U.S.C. § 337(a) .......................................................................................................... 6 Cal. Civ. Code § 3294 ......................................................................................... 2, 13, 14 Cal. Civ. Code § 3294(a) ........................................................................................ 14, 16 Cal. Civ. Code § 3294(b) .............................................................................................. 16 Rules Fed. R. Civ. P. 8(a) ....................................................................................................... 11 Fed. R. Civ. P. 12(b)(6) ............................................................................................ 3, 13 Regulations 21 C.F.R. § 810.15 ........................................................................................................ 13 Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 5 of 21 Page ID #:113 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 - 1 - DEFENDANTS’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e MEMORANDUM OF POINTS AND AUTHORITIES I. INTRODUCTION In this product liability action, Plaintiff alleges that he suffered personal injuries from an alleged implantation of a Composix® Kugel® Hernia Patch (hereinafter “CK Patch”)1 to repair a hernia. The FAC alleges claims for negligence, strict liability for manufacturing defect and inadequate warning, negligent misrepresentation, and it also demands punitive damages. However, many of these claims are supported by only conclusory allegations that fail to meet the pleading standards provided by Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) and Ashcroft v. Iqbal, 556 U.S. 662 (2009). They also fail as a matter of California law. Specifically, each of these causes of action should be dismissed for the following reasons: Plaintiff’s First Cause of Action for Negligence is insufficient because Plaintiff has not identified any manufacturing defect or inadequate warning about the CK Patch that is due to Defendants’ negligence. Further, to the extent that Plaintiff’s theory of negligence is premised on a purported “fraud on the FDA” or federal requirements, the claim cannot proceed under federal and California law. Plaintiff’s Second Cause of Action for Strict Products Liability - Manufacturing Defect fails because Plaintiff appears to be asserting a design-defect claim under the guise of a manufacturing defect. In spite of this Court’s guidance in another action involving the CK Patch, Plaintiff is unable to identify any particular manufacturing defect that “make[s] clear how [the plaintiff’s] patch differed from the intended design or from seemingly identical models.” Jager v. Davol, Inc., Case No. 16-1424JGB (KKx), 2016 WL 6157942, at *4 (C.D. Cal. Oct. 20, 2016) (original emphasis). This claim should be dismissed without leave to amend. 1 Although the FAC specifically alleges that Plaintiff Paul Wall was implanted with a Composix® Kugel® Patch, Plaintiff generally refers to the product as a “Kugel Patch” throughout the FAC. To be clear, the Kugel Patch is a different product from the Composix® Kugel® Patch. For accuracy, Defendants will refer to the subject product as a “CK Patch.” Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 6 of 21 Page ID #:114 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e Plaintiff’s Third Cause of Action for Strict Liability - Inadequate Warning fails because Plaintiff cannot establish that the Defendants knew or should have known of the purported dangers relating to the CK Patch at the time the device was manufactured or distributed that could have altered Plaintiff’s surgeon’s decision to implant it. This claim should be dismissed. Plaintiff’s Fourth Cause of Action for Negligent Misrepresentation fails because he does not identify a single affirmative misrepresentation that the Defendants made either to Plaintiff or to Plaintiff’s implanting surgeon - a requirement that the Court outlined in Jager. Id., *5. Rather, Plaintiff’s allegations are that Defendants omitted certain information to Plaintiff’s doctor both before and after the August 2004 CK Patch implant surgery, but this is not enough to state a cause of action for negligent misrepresentation. Finally, Plaintiff’s Punitive Damages demand should be dismissed because the amended allegations make clear that the pleadings are insufficient to establish that any of the corporate Defendants acted with malice, oppression or fraud pursuant to California Civil Code Section 3294. II. ALLEGATIONS IN THE COMPLAINT The FAC alleges that on or about August 25, 2004, Plaintiff Paul Wall underwent a hernia repair procedure during which a Bard® Composix® Kugel® Hernia Patch (Ref. #0010205, Lot# 43DOD283) (hereinafter, “CK Patch”) was implanted. [Doc. 19, ¶ 54] Over eleven years later, on or about August 27, 2015, Plaintiff alleges he developed a hernia mesh infection that required further surgery. [Id., ¶ 56] On September 2, 2015, Plaintiff underwent an exploratory laparotomy, surgical removal of the CK Patch, a small intestine segmental resection and an incidental appendectomy. [Id., ¶ 57] Plaintiff claims that in the operative report, the surgeon noted that the “[i]nfected mesh eroded and adhered to [Plaintiff’s] bowel forming an entercutaneous fistula, small serosal tears on one area of the colon were Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 7 of 21 Page ID #:115 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e found and closed.” [Id., ¶ 58] In addition, Plaintiff’s surgeon noted the discovery of “several different pieces of old mesh wadded up together with dense scarring and inflammatory tissue.” [Id., ¶ 59] He also removed “[t]here old silastic rings . . . all of which were already broken.” [Id.] There is no mention of any hernia mesh ring breaks. III. LEGAL STANDARD Dismissal under Federal Rule of Civil Procedure, Rule 12(b)(6) is appropriate where the complaint fails to state a claim for relief “that is plausible on its face.” Iqbal, 556 U.S. at 678; Twombly, 550 U.S. at 570. “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. It is “plaintiff’s obligation to provide . . . more than labels and conclusions” [Twombly, 550 U.S. at 555], and federal courts are “not bound to accept as true a legal conclusion couched as a factual allegation.” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 555); see also Erickson v. Boston Sci. Corp., 846 F. Supp. 2d 1085, 1089-90 (C.D. Cal. 2011). As this Court recognized: The Ninth Circuit has clarified that (1) a complaint must “contain sufficient allegations of underlying facts to give fair notice and to enable the opposing party to defend itself effectively,” and (2) “the factual allegations that are taken as true must plausibly suggest an entitlement to relief, such that it is not unfair to require the opposing party to be subjected to the expense of discovery and continued litigation.” Starr v. Baca, 652 F.3d 1202, 1216 (9th Cir. 2011). Jager, 2016 WL 6157942, at *2. Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 8 of 21 Page ID #:116 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e IV. ARGUMENT A. Plaintiff’s Negligence Claim (First Cause of Action) Fails Because Plaintiff Cannot and Has Not Established That The CK Patch Exhibited A Defect Due To Defendants’ Negligence Plaintiff’s negligence cause of action boils down to allegations that Defendants breached their duty of care with respect to manufacturing the CK Patch and providing appropriate warnings for the CK Patch to Plaintiff’s surgeon and the FDA. Each of these theories of liability fail. First, to state a claim for negligence based upon a manufacturing defect, Plaintiff must identify the product’s defect and establish “ʻan additional element, namely that defect in the product was due to negligence of the defendant.’” Merrill v. Navegar, Inc., 26 Cal. 4th 465, 479 (2001) (citations omitted) (outlining the elements necessary for a negligence cause of action claim in a decision involving summary judgment); see also Christensen v. Synthes USA, No. CIV 11-10369-GHK (RZx), 2013 WL 1899094, at *2 (C.D. Cal. May 6, 2013) (applying Merrill in the context of prescription medical device product liability claims); Knoppel v. St. Jude Med. Inc., No. SACV 13-383 JVS (ANx), 2013 WL 3803612, at *2-3 (C.D. Cal. May 7, 2013) (on a motion to dismiss, noting that under a negligence theory of products liability, a plaintiff must allege duty, breach and causation, and that “‘the defect in the product was due to the negligence of the defendant’” (citation omitted)). Plaintiff’s theory of manufacturing negligence does not meet both requirements. Plaintiff does not allege any facts establishing his conclusory statement that his CK Patch had a “defective memory recoil ring that fractured”, or what specifically was defective about his CK Patch. [Doc. 19, ¶ 71] Instead, the allegation consists solely of legal conclusions, i.e., the device was “prone to fail and malfunction,” but notably, does not allege the specifics of how it could fail or malfunction. Plaintiff also does not connect it to the Defendants’ negligent act in manufacturing the CK Patch implanted in Plaintiff. [Doc. 19, ¶ 73] Fontalvo ex rel. Fontalvo v. Sikorsky Aircraft Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 9 of 21 Page ID #:117 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e Corp., No. 13-cv-0331-GPC-KSC, 2013 WL 4401437 at *4-5 (S.D. Cal. Aug. 15, 2013) (granting motion to dismiss claim when plaintiff failed to plead any facts suggesting how defendants negligently manufactured or designed the product at issue). At best, Plaintiff claims that Defendants did not adequately test the weld strength of the memory coil ring [Doc. 19, ¶ 75], but Plaintiff did not establish that his CK Ring actually suffered from this defect, and further, that is not a manufacturing defect allegation. A cognizable manufacturing defect allegation should be aimed at establishing whether the CK Patch implanted in Plaintiff came off the production line defective in some way. Barker v. Lull Eng’g Co., 20 Cal. 3d 413, 429 (1978) (a manufacturing defect is “readily identifiable because a defective product is one that differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line”). Because there is no allegation of a manufacturing defect connected to Defendants’ alleged negligence, this theory of negligence is not sufficient. Second, Plaintiff alleges that Defendants failed to warn of the “defective nature” of the CK Patch, which allegedly had a “defective memory recoil ring that fractured while implanted in Plaintiff”. [Doc. 19, ¶ 71] But this allegation does not pass muster either because Plaintiff still does not connect this purported failure to what actually happened to his CK Patch, nor does he identify what the Defendants’ warnings about the CK Patch were and why they were inadequate. See Nimtz v. Cepin, Civ. No. 08cv1294 L(AJB), 2011 WL 831182, at *2-3 (S.D. Cal. Mar. 3, 2011) (dismissing plaintiff’s failure to warn claim because generic allegations that defendant failed to provide instructions and/or warnings “‘concerning the defective condition, characteristics, and risks associated with said product’” constituted a “legal conclusion that does not allege a plausible cause of action”). Furthermore, Plaintiff does not establish facts tending to show that the alleged Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 10 of 21 Page ID #:118 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e injuries resulted from an inadequacy in the warnings to the learned intermediary, i.e., that different or additional information about a medical device’s risks would have altered the prescribing physician’s decision to prescribe the drug or medical device. Motus v. Pfizer Inc. (Roerig Div.), 358 F.3d 659, 660-61 (9th Cir. 2004) (noting that if the plaintiff’s learned intermediary’s actions were unaffected by the warning label, then a product defect claim based on insufficient warning cannot survive summary judgment). Plaintiff merely alleges that there was a negligent failure to warn, but leaves unanswered in this claim whether that would have changed the surgeon’s conduct. Third, Plaintiff appears to hinge a negligence claim based upon a failure to properly warn or notify the FDA about purported defects in the CK Patch and failure to comply with federal regulations. [Doc. 19, ¶¶ 74, 76, 77] But this claim cannot proceed. “[F]raud on the FDA” type allegations are preempted under Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) and 21 U.S.C. § 337(a). In enacting the FDCA, Congress required that any action to enforce the FDCA “shall be by and in the name of the United States.” Buckman, 531 U.S. at 349 n.4, 352 (citing 21 U.S.C. § 337(a)); see also Coleman v. Medtronic, Inc., 223 Cal. App. 4th 413, 425 (2014) (state law cause of action for violation of the FDCA is barred under the doctrine of implied preemption if it is cognizable only by virtue of the provision of the FDCA itself, rather than traditional state tort law). “The FDA is responsible for investigating potential violations of the FDCA, and the Act provides the agency with a range of enforcement mechanisms, such as injunction proceedings, civil and criminal penalties, and seizure. 21 U.S.C. §§ 332-34, 372.” Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013). Furthermore, Plaintiff may not use a purported violation of a federal requirement as a basis to assert a “negligence per se” type claim since the doctrine of negligence per se does not provide a private right of action for violation of statutes Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 11 of 21 Page ID #:119 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e and regulations, such as those that govern the communications a medical device manufacturer must provide to the FDA. Das v. Bank of Am., N.A., 186 Cal. App. 4th 727, 737-38 (2010) (doctrine of negligence per se “ʻcreates an evidentiary presumption’” but “ʻdoes not provide a private right of action for violation of a statute.’”) (emphasis added, citations omitted). This theory of negligence fails to support Plaintiff’s negligence cause of action. While Plaintiff asserts a number of theories to support his negligence claim, they do not pass muster as they are either insufficiently alleged or allege a theory not permitted under federal and California law. This claim should be dismissed with prejudice. B. Plaintiff’s Strict Liability-Manufacturing Defect Claim (Second Cause of Action) Still Fails To Identify The Manufacturing Defect That His CK Patch Exhibited In a separate motion to dismiss decision rendered by this Court, Jager, which also involves the CK Patch, asserts similar and at times identical allegations as in the instant case, and was also brought by the same plaintiff’s counsel, the Court provided clear guidance on the sort of allegations a plaintiff needed to assert in order to maintain a manufacturing defect cause of action. Specifically, the Court recognized that in order to establish a manufacturing defect claim, a plaintiff must demonstrate that the product caused a plaintiff’s injury “because it deviated from the manufacturer’s intended result or from other ostensibly identical units of the same product line [omitting citations].” Jager, 2016 WL 6157942, at *2 (emphasis added). To illustrate a manufacturing defect claim, the Court further explained that a viable manufacturing theory “posits that ‘a suitable design is in place, but that the manufacturing process has in some way deviated from that design.’ Schwartz v. Wright Med. Tech., Inc., No. EDCV-1401615-JGB(SPX), 2014 WL 11320637, at *4 (C.D. Cal. Sept. 11, 2014) [omitting citations].” Id. Plaintiff’s amended manufacturing defect claim here does little to remedy the Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 12 of 21 Page ID #:120 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e defects noted by the Court in the Jager order. It recites the same “long string of possible problems that the ring might have…”, which the Jager Complaint also had recited,2 and like that Complaint, to the extent that Plaintiff appeared to argue that “all of the rings were vulnerable to this host of problems,” Plaintiff’s manufacturing claim still “seems more suited to a design defect cause of action, since it fails to identify how [the plaintiff’s] patch differed from the rest.” Id., at *3. Plaintiff’s pleading also remains deficient because it does not set out “allegations that make clear how [the plaintiff’s] patch differed from the intended design or from seemingly identical models.” Id., at *4; see Taragan v. Nissan N. Am., Inc., No. C 09-3660 SBA, 2013 WL 3157918, at *4 (N.D. Cal. June 20, 2013) (“ʻ[i]t is not enough to allege that a product line contains a defect or that a product is at risk for manifesting this defect; rather, the plaintiffs must allege that their product actually exhibited the alleged defect.’”) (emphasis added, citation omitted). At best, the FAC simply provides that as “[t]he result of the manufacturing defect in the weld of the ring”, Plaintiff suffered injury. [Doc. 19, ¶ 83] Tellingly, other than this bare assertion unmoored to the string of purported problems cited earlier, Plaintiff provides no other support except that an injury occurred. A manufacturing defect cannot be established by inference based on the fact that a plaintiff was allegedly injured while using the product. See Barrett v. Atlas Powder Co., 86 Cal. App. 3d 560, 565 (1978) (“[A]n inference of defect as a result of the accident is not to be drawn.”). There must be some causal link to the identified manufacturing defect and Plaintiff’s injuries. Rhynes v. Stryker Corp., No. 10-5619 SC, 2011 WL 2149095, at *2-3 (N.D. Cal. May 31, 2011) (granting motion to dismiss strict liability claim and negligence claims as conclusory allegations failed to allege causation, among other reasons); In re Toyota Unintended Acceleration Mktg., Sales Practices, and Prods. Liab. Litig., 754 F. Supp. 2d 1208, 1220, 1223 (C.D. Cal. 2010) 2Paragraph 21 of Plaintiff’s FAC is nearly identical to Paragraph 22 of the Jager Complaint, except the FAC does not refer to a design defect. Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 13 of 21 Page ID #:121 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e (“a bare allegation that the product ʻsuffered from a “design defect” is an insufficient legal conclusion’ under Twombly and Iqbal”). Because Plaintiff has failed to remedy the deficiencies in his claim despite amending it once, the strict liability-manufacturing defect claim should be dismissed with prejudice. C. Plaintiff Is Unable To State A Claim For Strict Liability-Inadequate Warning (Third Cause of Action) Plaintiff’s strict product liability-inadequate warning claim is deficient because the FAC cannot establish that Defendants knew or should have known of the purported dangers relating to the CK Patch prior to Plaintiff’s CK Patch implant surgery in August 2004, or at the time of its manufacture and distribution, such that a warning should have been provided to Plaintiff’s doctor. Pharmaceutical manufacturers may be held strictly liable for failing to warn of known or reasonably scientifically knowable risks. Carlin v. Superior Court, 13 Cal. 4th 1104, 1110 (1996). “The rules of strict liability require a plaintiff to prove only that the defendant did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution.” Id. at 1112. The manufacturer’s knowledge is measured at the time of distribution, rather than on the basis of subsequent scientific developments. Id. (citing Brown v. Superior Court, 44 Cal. 3d 1049, 1060 n.8 (1988) (noting that if a manufacturer could not count on limiting its liability to risks known or knowable at time of manufacture and distribution, it would be discouraged from developing new and improved products)). In addition, California applies the “learned intermediary” doctrine, which holds that a medical device or prescription drug manufacturer’s duty to warn runs to the prescribing physician, not the patient. See Plenger v. Alza Corp., 11 Cal. App. 4th 349, 361 n.6 (1992) (“It is well established that a manufacturer fulfills its duty to warn if it provides adequate warning to the physician.”). Therefore, in a failure-to-warn Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 14 of 21 Page ID #:122 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e case involving a prescription medical device, a plaintiff can demonstrate causation only by pleading and proving that different or additional information about a medical device’s risks would have altered the prescribing physician’s decision to use the product. See Dilley v. C.R. Bard, Inc., 2:14-cv-01795-ODW (ASx), 2014 WL 1338877, at *4 (C.D. Cal. Apr. 3, 2014) (dismissing failure-to-warn claim because “the learned intermediary’s prescription of the medical devices in light of knowledge of the risks precludes a failure-to-warn claim”).3 Here, Plaintiff’s own failure-to-warn allegations do not plausibly state a scenario where Defendants knew or should have known that the CK Patch used in Plaintiff was dangerous and that a warning should have been provided when it was implanted in Plaintiff. There are also no allegations about what the Defendants knew or should have known from the state of knowledge in the scientific community at the time the device was implanted. Rather, Plaintiff’s allegations paint a scenario where Defendants were still investigating the issue of a potential ring break when Plaintiff was implanted with the CK Patch. Specifically, they allege that while Defendants first learned of “a ring break in its Kugel Patch product line in 2003,” they initiated an investigation but did not learn of an increase in reported ring breaks until “mid or late 2005”. [Doc. 19, ¶¶ 25-27] The CK Patch at issue here was implanted in August 2004. Plaintiff provides no other facts establishing that a reasonable manufacturer should have issued a warning at this earlier point in time. While there are certainly allegations that the Defendants learned of a purported increase in ring breaks, reported them to the FDA, and initiated recalls, none of these 3 Moreover, when other product liability claims, such as negligence, manufacturing defect and negligent misrepresentation, are premised on a failure-to-warn, those claims similarly fail where different warnings would not have affected the prescriber’s decision to use the product. See, e.g., Huntman v. Danek Med., Inc., No. 97-2155- IEG RBB, 1998 WL 663362, at *5 (S.D. Cal. July 24, 1998) (dismissing strict liability, failure to warn, negligence, breach of warranty and fraud claims under California law on summary judgment against medical device manufacturer where there was “absolutely no evidence that [surgeon] relied on any statements made by defendant”). To the extent Plaintiff base his other claims on a purported failure-to- warn, they must fail as well. Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 15 of 21 Page ID #:123 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e events happened prior to Plaintiff’s implant surgery in August 2004 either, and could not have plausibly altered his surgeon’s decision to implant it. Further, Plaintiff’s attempt to impose a post-implant duty to warn is not well taken [Doc. 19, ¶ 105], as California law evaluates the warnings provided at the time the device was manufactured and distributed, not after the device was implanted. Plaintiff’s allegations “stops short of the line between possibility and plausibility of ‘entitlement to relief,’” and should therefore be dismissed without leave to amend. Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 557). D. Plaintiff’s Negligent Misrepresentation Claim (Fourth Cause of Action) Still Fails To Identify Any Affirmative Misrepresentations That Plaintiff Or His Surgeon Relied Upon To Their Detriment As the Court outlined in the Jager order, in order to assert a claim for negligent misrepresentation, Plaintiff must establish the following elements pursuant to Rule 8(a)4: that Defendants “(1) made a misrepresentation of a past or existing material fact, (2) without reasonable ground for believing it to be true, (3) with intent to induce another's reliance on the fact misrepresented, (4) justifiable reliance on the misrepresentation, and (5) with resulting damage.” Jager, 2016 WL 6157942, at *5. “[C]rucial to a negligent misrepresentation claim” is the requirement that Plaintiff plead “an affirmative representation.” Id. (noting that since negligent misrepresentation does not require scienter, the lesser mental state “is balanced by its requirements of a false positive assertion or assertion of fact, and not a mere implied assertion.” (emphasis added, citations omitted)). The FAC delineates between purported negligent misrepresentations made to Plaintiff’s surgeon both before and after the implant surgery. Under both time- frames, however, the claims fail because Plaintiff does not identify any plausible 4Pursuant to the Court’s guidance in Jager, Defendants will use Rule 8(a) as the pleading standard for the Negligent Misrepresentation claim. Jager, 2016 WL 6157942, at *5 (agreeing with the reasoning of Peterson v. Allstate Indem. Co., 281 F.R.D. 413, 416 (C.D. Cal. 2012) and applying Rule 8(a) to a negligent misrepresentation claim. Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 16 of 21 Page ID #:124 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e affirmative misrepresentation that goes beyond what the Court found lacking in the original Complaint. As to events prior to the surgery, Plaintiff alleges that Defendants made purported misrepresentations and omissions to Plaintiff’s surgeon about the safety of the CK Patch. [E.g., Doc. 19, ¶¶ 114-118] But this conclusory statement about “misrepresentations” is contradicted by other allegations. For instance, while Plaintiff alleges that Defendants’ investigation into complaints about purported ring breaks started in 2003, Plaintiff alleges that it was not until December 28, 2005 (or nearly a year after Plaintiff’s October 2004 implant surgery), when Defendants made misrepresentations to any surgeon or the medical community. Indeed, that is the very basis of Plaintiff’s criticism. [Id., at ¶¶ 110-114 (“However, even though Defendants had enough information about the ring breaks to halt production of the Kugel Patch, Defendants still chose not to inform physicians, such as Plaintiff’s surgeon, about the numerous complaints they received reporting ring breaks.” (emphasis added))] A court is “not required to accept as true conclusory allegations which are contradicted by documents referred to in the complaint.” Steckman v. Hart Brewing Inc., 143 F.3d 1293, 1295-96 (9th Cir. 1998). As to events after Plaintiff’s surgery, Plaintiff asserts allegations that are unsupported by a plausible theory of liability. “[A] court need not blindly accept conclusory allegations, unwarranted deductions of fact, and unreasonable inferences.” Dilley, 2014 WL 1338877, at *2 (citing Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001). Essentially, Plaintiff criticizes Defendants for failing to inform Plaintiff’s surgeon about the “defective weld issue and ring breaks” such that Plaintiff did not have the option to remove the CK Patch until September 2015 when he experienced a hernia mesh infection. [Doc. 19, ¶¶ 120-21] But this is again contradicted by allegations that after Plaintiff’s CK Patch implant, his CK Patch was included in the recall of January 2007 where presumably the FDA-required Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 17 of 21 Page ID #:125 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e information about the recall was conveyed to the medical community, including Plaintiff’s surgeon. [Id., ¶¶ 33-35 and fn. 6, 45] See 21 C.F.R. § 810.15 (mandatory medical device recall procedures outlining the individuals to whom specific communications about the recalled device should be provided). Furthermore, while the FAC outlines instances of the Defendants’ purported under-reporting of complaints to the FDA, Plaintiff does not allege that Defendants under-reported complaints or made affirmative misrepresentations to Plaintiff’s doctor. Plaintiff’s chief complaint boils down to a criticism that Defendants did not provide more information about the complaints received, not that the Defendants made any affirmative misrepresentations. [Compare Doc. 19, ¶¶ 44-45 (alleging that the Defendants purportedly underreported to the FDA that they received 28 complaints of broken rings, when there were purportedly at least 85 complaints of broken rings, out of a total of 80,945 CK Products that were recalled as of January 2007) with ¶¶ 31-33, 35 (indicating that while Defendants informed the public about complaints having been received for the CK Patch, there are no allegations of any misrepresentations made about the number of ring break complaints received)]. Accordingly, these allegations are not sufficient to state a claim for negligent misrepresentation, and the Court should dismiss the claim without leave to amend. E. Plaintiff’s Claim For Punitive Damages Should Be Dismissed Plaintiff’s request for punitive damages should be dismissed under Rule 12(b)(6) because the FAC does not allege facts showing the requisite oppression, fraud, or malice committed by any of the corporate Defendants pursuant to the requirements of California Civil Code section 3294.5 To recover punitive damages in a tort action under California law, plaintiff must plead and prove by “clear and convincing evidence that the defendant has been guilty 5 The proper medium for challenging the sufficiency of factual allegations related to punitive damages is Rule 12(b)(6). Whittlestone, Inc. v. Handi-Craft Co., 618 F.3d 970, 974-75 (9th Cir. 2010). Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 18 of 21 Page ID #:126 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e of oppression, fraud, or malice . . . .” See Cal. Civ. Code § 3294(a) (emphasis added); Brousseau v. Jarrett, 73 Cal. App. 3d 864, 872 (1977). While in federal court Section 3294 provides the substantive law for punitive damages, District Courts sitting in California apply federal pleading standards to assess whether the allegations are sufficient to state a demand for punitive damages. Thus, a demand for punitive damages must still set forth factual allegations sufficient “to raise a right to relief above the speculative level.” Twombly, 550 U.S. at 555. Accordingly, dismissal of punitive damages claims with prejudice is proper where the complaint fails to state specific facts supporting allegations of malice, oppression or fraud. Mere conclusory recitations of “ʻconscious disregard of [Plaintiff's] rights and with the intent to vex, injure and annoy [Plaintiff] such as to constitute oppression, fraud or malice’” are not considered sufficient. Kelley v. Corr. Corp. of Am., 750 F. Supp. 2d 1132, 1146 (E.D. Cal. 2010); see Granger v. Lowe’s Home Ctrs., LLC, No. 1:14-CV-01212-KJM-SKO, 2014 WL 4976134, at *6 (E.D. Cal. Oct. 3, 2014) (following Kelley to hold that conclusory allegations that the defendants’ actions were “ʻintentional and malicious’” were not sufficient to state a demand for punitive damages and stating that the complaint “may at most imply negligence, carelessness, and surprising ineptitude”). Here, Plaintiff’s punitive damages demand [Doc. 19, Section V, Paragraph C] cannot proceed as the FAC’s allegations do not give rise to punitive damages. Plaintiff’s negligence cause of action only sets forth allegations of negligence, and not of any actions that were set out with an intent to defraud or deceive. By its very terms, negligent actions cannot be squared with “tortious conduct” that “rises to levels of extreme indifference to the plaintiff’s rights, a level which decent citizens should not have to tolerate.” Food Pro Int’l, Inc. v. Farmers Ins. Exch., 169 Cal. App. 4th 976, 994 (2008) (citation and internal quotation marks omitted); see also Ferguson v. Lieff, Cabraser, Heimann & Bernstein, 30 Cal. 4th 1037, 1046 (2003) (“ʻPunitive damages by definition are not intended to compensate the injured party, but rather to Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 19 of 21 Page ID #:127 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e punish the tortfeasor whose wrongful action was intentional or malicious, and to deter him and others from similar extreme conduct.’” (citation omitted)). Plaintiff’s allegations brought under the strict liability causes of action are also insufficient to merit punitive damages since Plaintiff does not allege either the existence of any manufacturing defect in the CK Patch that caused injury, or that Defendants knew or should have known about the purported dangers of the CK Patch at the time it was manufactured and distributed, much less when the device was implanted in August 2004. Compare with Tapia v. Davol, Inc., No. 15cv179-GPC JLB, 2015 WL 6828660, at * 8 (S.D. Cal. Nov. 6, 2015) (in a CK Patch case, denying motion to dismiss because of allegations that defendants failed to provide accurate information and warning to the healthcare community, where the plaintiff’s implant surgery occurred in December 2005). Plaintiff’s negligent misrepresentation cause of action is likewise insufficient to support a demand for punitive damages since there are no allegations of any affirmative misrepresentations that Defendants committed, much less any undertaken with malice, oppression or fraud. Furthermore, Plaintiff’s allegations are also insufficient to support punitive damages because they fail to distinguish among the three Defendants. The FAC draws no distinction among Defendants to differentiate who caused the injury, how each Defendant caused the specific injury, or when each Defendant caused the injury. In order to provide Defendants with fair notice of the punitive damages demand against them, Plaintiff must be required to allege more than generic boilerplate allegations and provide factually specific allegations of conduct on the part of each Defendant that would support punitive damages. See GBTI, Inc. v. Ins. Co. of Pa., No. CV F 09-1173 LJO DLB, 2009 WL 2365409, at *8 (E.D. Cal. July 29, 2009). // // Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 20 of 21 Page ID #:128 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’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e V. CONCLUSION Each of these causes of action and demand for punitive damages fails because: (1) the First Cause of Action for Negligence fundamentally fails to allege any viable theory of negligence that caused injury, (2) the Second Cause of Action for strict liability-manufacturing defect fails to identify how Plaintiff’s CK Patch deviated from its intended design or differed from other seemingly identical units of the same model and caused Plaintiff injury, (3) the Third Cause of Action for strict liability-inadequate warning fails to establish that Defendants knew or should have known about any issue with the CK Patch at the time of its manufacture and distribution such that any warnings would have altered Plaintiff’s doctor to use the CK Patch, (4) the Fourth Cause of Action for negligent misrepresentation fails because Plaintiff has not alleged any misrepresentations made to Plaintiff’s doctor either before or after the implant surgery, and (5) the demand for punitive damages fails because Plaintiff makes conclusory allegations that do not meet the requirements set out in California Civil Code section 3294(a) and (b). For these reasons, Defendants request that Plaintiff’s FAC be dismissed with prejudice. Dated: December 1, 2016 REED SMITH LLP By /s/ Michelle L. Cheng Michael K. Brown Marilyn A. Moberg Michelle L. Cheng Attorneys for Defendants Davol Inc., Bard Devices, Inc. and C. R. Bard, Inc. Case 5:16-cv-01761-JGB-KK Document 21-1 Filed 12/01/16 Page 21 of 21 Page ID #:129 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 DEFENDANTS’ MOTION TO DISMISS FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA PAUL WALL, Plaintiff, vs. DAVOL INC.; BARD DEVICES, INC.; C.R. BARD; and DOES 1-10, inclusive, Defendants. Case No. 5:16-CV-01761-JGB(KKx) [PROPOSED] ORDER GRANTING DEFENDANTS DAVOL INC., BARD DEVICES, INC. AND C.R. BARD, INC.’S MOTION TO DISMISS FIRST AMENDED COMPLAINT Compl. Filed: August 17, 2016 FAC Filed: November 10, 2016 Hearing Date: February 27, 2017 Time: 9:00 a.m. Courtroom: 1 Honorable Jesus G. Bernal [Concurrently Filed With Notice of Motion and Motion and Memorandum of Points and Authorities] Case 5:16-cv-01761-JGB-KK Document 21-2 Filed 12/01/16 Page 1 of 2 Page ID #:130 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 DEFENDANTS’ MOTION TO DISMISS FIRST AMENDED COMPLAINT R EE D S M IT H L LP A li m ite d lia bi lit y pa rtn er sh ip fo rm ed in th e St at e of D el aw ar e [Proposed] Order Defendants Davol Inc., Bard Devices, Inc. and C. R. Bard, Inc.’s Motion to Dismiss Plaintiff Paul Wall’s First Amended Complaint came on for hearing on February 27, 2017, before this Court. After full consideration of all papers, pleadings, and matters subject to judicial notice, as well as counsel’s oral argument, and good cause appearing therefore, IT IS ORDERED THAT: Defendants’ Motion to Dismiss Plaintiff’s First Amended Complaint pursuant to Federal Rules of Civil Procedure, Rule 12(b)(6) for failure to state a claim is hereby GRANTED. The Court finds that the First Amended Complaint fails to state a claim upon which relief can be granted. Because the deficiencies of Plaintiff’s First Amended Complaint cannot be cured by amendment, it is dismissed with prejudice in its entirety without leave to amend. IT IS SO ORDERED. DATED: _______________ ____________________________________ Honorable S. Jesus G. Bernal United States District Judge Case 5:16-cv-01761-JGB-KK Document 21-2 Filed 12/01/16 Page 2 of 2 Page ID #:131