Donna Jager et al v. Davol, Inc. et al

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

C.D. Cal.November 28, 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 Eric J. Buhr (SBN 217528) Email: ebuhr@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 DONNA JAGER and JOHN JAGER, Plaintiffs, vs. DAVOL INC.; BARD DEVICES, INC.; C.R. BARD; and DOES 1-10, inclusive, Defendants. Case No. 5:16-CV-01424-JGB-KK 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 Compl. Filed: July 1, 2016 Hearing Date: February 13, 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-01424-JGB-KK Document 23 Filed 11/28/16 Page 1 of 4 Page ID #:189 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’ 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 13, 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 Plaintiffs Donna and John 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 Plaintiffs have 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: Plaintiffs’ First Cause of Action for Negligence is insufficient because Plaintiffs have not identified any manufacturing defect or inadequate warning about the CK Patch that is due to Defendants’ negligence. Further, to the extent that Plaintiffs’ theory of negligence is premised on a purported “fraud on the FDA” or federal requirements, the claim cannot proceed under federal and California law. Plaintiffs’ Second Cause of Action for Strict Products Liability - Manufacturing Defect fails because although they disavow it, they appear to be asserting a design-defect claim under the guise of a manufacturing defect. Plaintiffs remain unable to identify any particular manufacturing defect that “make[s] clear how Ms. Jager’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. Plaintiffs’ Third Cause of Action for Strict Liability - Inadequate Warning fails because Plaintiffs cannot establish that the Defendants knew or should have known of Case 5:16-cv-01424-JGB-KK Document 23 Filed 11/28/16 Page 2 of 4 Page ID #:190 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 the purported dangers relating to the CK Patch at the time the device was manufactured or distributed that could have altered Plaintiffs’ surgeon’s decision to implant it. This claim should be dismissed. Plaintiffs’ Fourth Cause of Action for Negligent Misrepresentation fails because they still do not identify a single affirmative misrepresentation that the Defendants made either to Plaintiffs or to Plaintiff’s implanting surgeon - a requirement that the Court outlined in its prior order. Id., *5. Rather, Plaintiffs’ allegations are still that Defendants omitted certain information to Plaintiff’s doctor both before and after the October 2004 CK Patch implant surgery, but this is not enough to state a cause of action. To the extent that the causes of actions asserted by Plaintiff Donna Jager are dismissed, Plaintiffs’ Fifth Cause of Action for Loss of Consortium should also be dismissed as it depends on allegations of tortious conduct suffered by Plaintiff Donna Jager. Finally, Plaintiffs’ 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. // // Case 5:16-cv-01424-JGB-KK Document 23 Filed 11/28/16 Page 3 of 4 Page ID #:191 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 Dated: November 28, 2016 REED SMITH LLP By /s/ Michelle L. Cheng Michael K. Brown Marilyn A. Moberg Eric J. Buhr Michelle L. Cheng Attorneys for Defendants Davol Inc., Bard Devices, Inc. and C. R. Bard, Inc. Case 5:16-cv-01424-JGB-KK Document 23 Filed 11/28/16 Page 4 of 4 Page ID #:192 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 Eric J. Buhr (SBN 217528) Email: ebuhr@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 DONNA JAGER and JOHN JAGER, Plaintiffs, vs. DAVOL INC.; BARD DEVICES, INC.; C.R. BARD; and DOES 1-10, inclusive, Defendants. Case No. 5:16-CV-01424-JGB-KK DEFENDANTS DAVOL INC., BARD DEVICES, INC., AND C.R. BARD, INC.’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS AS TO THE FIRST AMENDED COMPLAINT Compl. Filed: July 1, 2016 Hearing Date: February 13, 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-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 1 of 22 Page ID #:193 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 MEMORANDUM OF POINTS AND AUTHORITIES ................................................ 1 I. INTRODUCTION ................................................................................................ 1 II. ALLEGATIONS IN THE COMPLAINT ............................................................ 2 III. LEGAL STANDARD .......................................................................................... 3 IV. ARGUMENT........................................................................................................ 3 A. Plaintiffs’ Negligence Claim (First Cause of Action) Fails Because Plaintiffs Cannot and Have Not Established That The CK Patch Exhibited A Defect Due To Defendants’ Negligence ............... 3 B. Plaintiffs’ Strict Liability-Manufacturing Defect Claim (Second Cause of Action) Still Fails To Identify The Manufacturing Defect That Her CK Patch Exhibited ......................................................... 7 C. Plaintiffs Are Unable To State A Claim For Strict Liability- Inadequate Warning (Third Cause of Action) ........................................... 9 D. Plaintiffs’ Negligent Misrepresentation Claim (Fourth Cause of Action) Still Fails To Identify Any Affirmative Misrepresentations That Plaintiffs Or Their Surgeon Relied Upon To Their Detriment ......................................................................... 11 E. Plaintiffs’ Loss Of Consortium (Fifth Cause of Action) Is A Derivative Claim That Should Be Dismissed As Well ............................ 13 F. Plaintiffs’ Claim For Punitive Damages Should Be Dismissed .............. 13 V. CONCLUSION .................................................................................................. 16 Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 2 of 22 Page ID #:194 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)......................................................................................... 3, 8, 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)................................................................................... 3, 8, 11, 14 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) .................................................................................... 6 Dilley v. C.R. Bard, Inc., 2:14-cv-01795-ODW (ASx), 2014 WL 1338877 (C.D. Cal. Apr. 3, 2014) .................................................................................................................... 9, 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) ........................................................................................... 15 Fontalvo ex rel. Fontalvo v. Sikorsky Aircraft Corp., No. 13-cv-0331-GPC-KSC, 2013 WL 4401437 (S.D. Cal. Aug. 15, 2013) .......................................................................................................................... 4 Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 3 of 22 Page ID #:195 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 Food Pro Int’l, Inc. v. Farmers Ins. Exch., 169 Cal. App. 4th 976 (2008) .................................................................................. 15 GBTI, Inc. v. Ins. Co. of Pa., No. CV F 09-1173 LJO DLB, 2009 WL 2365409 (E.D. Cal. July 29, 2009) ........................................................................................................................ 16 Granger v. Lowe’s Home Ctrs., LLC, No. 1:14-CV-01212-KJM-SKO, 2014 WL 4976134 (E.D. Cal. Oct. 3, 2014) ........................................................................................................................ 14 Hahn v. Mirda, 147 Cal. App. 4th 740 (2007) .................................................................................. 13 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 LeFiell Mfg. Co. v. Superior Court, 55 Cal. 4th 275 (2012) ............................................................................................. 13 Merrill v. Navegar, Inc., 26 Cal. 4th 465 (2001) ............................................................................................... 4 Motus v. Pfizer Inc. (Roerig Div.), 358 F.3d 659 (9th Cir. 2004) ..................................................................................... 5 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 Rodriguez v. Bethlehem Steel Corp., 12 Cal. 3d 382 (1974) .............................................................................................. 13 Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 4 of 22 Page ID #:196 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 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 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) ................................................................................... 14 Statutes 21 U.S.C. § 337(a) .......................................................................................................... 6 Cal. Civ. Code § 3294 ......................................................................................... 2, 14, 16 Rules Fed. R. Civ. P. 8(a) ....................................................................................................... 11 Fed. R. Civ. P. 12(b)(6) ............................................................................................ 3, 14 Regulations 21 C.F.R. § 810.15 ........................................................................................................ 12 Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 5 of 22 Page ID #:197 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 Plaintiffs Donna and John Jager’s First Amended Complaint fails to remedy the deficiencies of their prior Complaint and makes clear that Plaintiffs cannot bring an actionable claim against the Defendants under any theory of liability. Plaintiffs re- assert Strict Products Liability - Manufacturing Defect and Negligent Misrepresentation claims, but they do not allege sufficient facts to satisfy the guidance provided in the Court’s prior order. Furthermore, Plaintiffs’ Negligence and Strict Products Liability - Inadequate Warning claims are also not sufficient. Plaintiffs’ First Cause of Action for Negligence is insufficient because Plaintiffs have not identified any manufacturing defect or inadequate warning about the CK Patch that is due to Defendants’ negligence. Further, to the extent that Plaintiffs’ theory of negligence is premised on a purported “fraud on the FDA” or federal requirements, the claim cannot proceed under federal and California law. Plaintiffs’ Second Cause of Action for Strict Products Liability - Manufacturing Defect fails because although they disavow it, they appear to be asserting a design-defect claim under the guise of a manufacturing defect. Plaintiffs remain unable to identify any particular manufacturing defect that “make[s] clear how Ms. Jager’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. Plaintiffs’ Third Cause of Action for Strict Liability - Inadequate Warning fails because Plaintiffs 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 Plaintiffs’ surgeon’s decision to implant it. This claim should be dismissed. Plaintiffs’ Fourth Cause of Action for Negligent Misrepresentation fails Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 6 of 22 Page ID #:198 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 because they still do not identify a single affirmative misrepresentation that the Defendants made either to Plaintiffs or to Plaintiff’s implanting surgeon - a requirement that the Court outlined in its prior order. Id., *5. Rather, Plaintiffs’ allegations are still that Defendants omitted certain information to Plaintiff’s doctor both before and after the October 2004 CK Patch implant surgery, but this is not enough to state a cause of action for negligent misrepresentation. To the extent that the causes of actions asserted by Plaintiff Donna Jager are dismissed, Plaintiffs’ Fifth Cause of Action for Loss of Consortium should also be dismissed as it depends on allegations of tortious conduct suffered by Plaintiff Donna Jager. Finally, Plaintiffs’ 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 October 4, 2004, Plaintiff Donna Jager underwent a hernia repair procedure during which a Bard® Composix® Kugel® Hernia Patch (Ref. #0010206, Lot#43DOD291) (hereinafter, “CK Patch”) was implanted. [Doc. 21, ¶ 53] Over a decade later, on or about April 3, 2015, Plaintiff alleges she developed a hernia mesh infection that required further surgery. [Id., ¶ 56] On April 3, 2015, Plaintiff underwent an exploratory laparotomy, open ventral hernia repair, and an appendectomy. [Id., ¶ 57] Plaintiff claims that in the operative report, the surgeon observed that “[f]urther inspection revealed the tract of the fistula emanating from the tip of the appendix. In that area the ring from the Bard mesh had fractured and was poking into the tip of [Plaintiff’s] appendix.” [Id., ¶ 59 (original emphasis)] During the course of dissecting the mesh from Plaintiff’s Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 7 of 22 Page ID #:199 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 abdominal wall, Plaintiff underwent an appendectomy. [Id., ¶ 61] 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.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). “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. IV. ARGUMENT A. Plaintiffs’ Negligence Claim (First Cause of Action) Fails Because Plaintiffs Cannot and Have Not Established That The CK Patch Exhibited A Defect Due To Defendants’ Negligence Plaintiffs’ negligence cause of action boils down to allegations that Defendants Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 8 of 22 Page ID #:200 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 breached their duty of care with respect to manufacturing the CK Patch and providing appropriate warnings for the CK Patch to Plaintiffs’ surgeon and the FDA. Each of these theories of liability fail. First, to state a claim for negligence based upon a manufacturing defect, Plaintiffs must not only identify the product’s defect, but must also 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)). Plaintiffs’ theory of manufacturing negligence does not satisfy this requirement. Instead, without factual support, Plaintiffs’ claim 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, and connect it to the Defendants’ negligent act in manufacturing the CK Patch implanted in Plaintiff. [Doc. 21, ¶ 62] Fontalvo ex rel. Fontalvo v. Sikorsky Aircraft 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, Plaintiffs claim that Defendants did not adequately test the weld strength of the memory coil ring [Doc. 21, ¶ 80], but that is not a manufacturing Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 9 of 22 Page ID #:201 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 defect allegation, which should be aimed at establishing whether the CK Patch implanted in Plaintiff Donna Jager 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, Plaintiffs allege 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. 21, ¶ 76] But this allegation does not pass muster either because Plaintiffs still do not 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, Plaintiffs do not establish facts tending to show that the alleged 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). Plaintiffs merely allege that there was a negligent failure to warn, but leaves Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 10 of 22 Page ID #:202 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 unanswered in this claim whether that would have changed the surgeon’s conduct. Third, Plaintiffs appear 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. 21, ¶¶ 79, 82, 83] 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, Plaintiffs 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 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 Plaintiffs’ negligence cause Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 11 of 22 Page ID #:203 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 of action. While Plaintiffs assert a number of theories to support their 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. Plaintiffs’ Strict Liability-Manufacturing Defect Claim (Second Cause of Action) Still Fails To Identify The Manufacturing Defect That Her CK Patch Exhibited In the prior Order on Defendants’ Motion to Dismiss this Second Cause of Action, the Court provided clear guidance on the sort of allegations Plaintiffs 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. Plaintiffs’ amended manufacturing defect claim does little to remedy the defects noted by the Court in its prior order. It repeats the same “long string of possible problems that the ring might have…”,1 and like the original Complaint, to the extent that Plaintiffs appeared to argue that “all of the rings were vulnerable to this host of problems,” Plaintiffs’ manufacturing claim still “seems more suited to a design defect cause of action, since it fails to identify how Ms. Jager’s patch differed from the rest.” 1Paragraph 22 of the FAC is nearly identical to Paragraph 22 of the Complaint, except the FAC now deletes any reference of a design defect. Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 12 of 22 Page ID #:204 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 Id., at *3.2 Plaintiffs’ pleading also remains deficient because they do not set out “allegations that make clear how Ms. Jager’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. 21, ¶ 89] Tellingly, other than this bare assertion unmoored to the string of purported problems cited earlier, Plaintiffs provide 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 Plaintiffs’ 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) (“a bare allegation that the product ʻsuffered from a “design defect” is an insufficient legal conclusion’ under Twombly and Iqbal”). Because Plaintiffs have failed to remedy the deficiencies in their claim despite the Court’s prior order, the strict liability-manufacturing defect claim should be dismissed with prejudice. 2In the FAC, Plaintiffs have struck all references to design defect. Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 13 of 22 Page ID #:205 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 C. Plaintiffs Are Unable To State A Claim For Strict Liability-Inadequate Warning (Third Cause of Action) Plaintiffs’ 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 October 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 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 Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 14 of 22 Page ID #:206 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 “the learned intermediary’s prescription of the medical devices in light of knowledge of the risks precludes a failure-to-warn claim”).3 Here, Plaintiffs’ 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, Plaintiffs’ 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. 21, ¶¶ 26-28] The CK Patch at issue here was implanted in October 2004. Plaintiffs provide 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 events happened prior to Plaintiff’s implant surgery in October 2004 either, and could not have plausibly altered her surgeon’s decision to implant it. Further, Plaintiffs’ attempt to impose a post-implant duty to warn is not well taken, as California law evaluates the warnings provided at the time the device was manufactured and distributed, not after the device was implanted. Plaintiffs’ allegations “ʻstops short of 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 Plaintiffs base their other claims on a purported failure-to- warn, they must fail as well. Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 15 of 22 Page ID #:207 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 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. Plaintiffs’ Negligent Misrepresentation Claim (Fourth Cause of Action) Still Fails To Identify Any Affirmative Misrepresentations That Plaintiffs Or Their Surgeon Relied Upon To Their Detriment As the Court outlined in its prior Order, in order to assert a claim for negligent misrepresentation, Plaintiffs 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 now 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 Plaintiffs do not identify any plausible affirmative misrepresentation that goes beyond what the Court found lacking in the original Complaint. As to events prior to the surgery, Plaintiffs allege that Defendants made purported misrepresentations and omissions to Plaintiff’s surgeon about the safety of the CK Patch. [E.g., Doc. 21, ¶¶ 120-123] But this conclusory statement about 4Pursuant to the Court’s prior order, 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-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 16 of 22 Page ID #:208 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 “misrepresentations” is contradicted by other allegations. For instance, while Plaintiffs allege that Defendants’ investigation into complaints about purported ring breaks started in 2003, Plaintiffs allege 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 Plaintiffs’ criticism. [Id., at ¶¶ 116-120 (“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, Plaintiffs assert 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, Plaintiffs criticize 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 April 2015 when she experienced a hernia mesh infection. [Doc. 21, ¶¶ 125-26] But this is again contradicted by allegations that after Plaintiff’s CK Patch implant, her CK Patch was included in the recalls of December 2005 and January 2006, where presumably the FDA-required information about the recall was conveyed to the medical community, including Plaintiff’s surgeon. [Id., ¶¶ 34-36 and fn. 6, 46, 47] 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 Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 17 of 22 Page ID #:209 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 under-reporting of complaints to the FDA, Plaintiffs do not allege that Defendants under-reported complaints or made affirmative misrepresentations to Plaintiffs’ doctor. Plaintiffs’ 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, which is what the Court required. [Compare Doc. 21, ¶ 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 ¶ 32 (quoting from “Urgent Product Recall” notice to the medical community where Defendants indicated that “complaint reports” were reported)] 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. Plaintiffs’ Loss Of Consortium (Fifth Cause of Action) Is A Derivative Claim That Should Be Dismissed As Well California law is well established that a loss of consortium claim is derivative in nature and necessarily depends on the viability of the causes of action for tortious injury to the spouse. LeFiell Mfg. Co. v. Superior Court, 55 Cal. 4th 275, 284-85, (2012) (quoting Hahn v. Mirda, 147 Cal. App. 4th 740, 746 n.2 (2007)). Accordingly, to the extent that the claims brought by Plaintiff Donna Jager are dismissed, the loss of consortium claim must be dismissed as well. Further, to the extent Plaintiff John Jager seeks a loss of his earnings or earning capacity due to his care for Plaintiff Donna Jager, such a demand is barred under California law. Rodriguez v. Bethlehem Steel Corp., 12 Cal. 3d 382, 409 (1974). F. Plaintiffs’ Claim For Punitive Damages Should Be Dismissed Plaintiffs’ request for punitive damages should be dismissed under Rule Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 18 of 22 Page ID #:210 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 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 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, Plaintiffs’ continued punitive damages demand [Doc. 21, Section V, Paragraph C] cannot proceed as the FAC’s allegations do not give rise to punitive damages. 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-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 19 of 22 Page ID #:211 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 Plaintiffs’ 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 punish the tortfeasor whose wrongful action was intentional or malicious, and to deter him and others from similar extreme conduct.’” (citation omitted)). Plaintiffs’ allegations brought under the strict liability causes of action are also insufficient to merit punitive damages since Plaintiffs do 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 October 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). Plaintiffs’ 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, Plaintiffs’ 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 Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 20 of 22 Page ID #:212 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 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, Plaintiffs 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). V. CONCLUSION Defendants are sympathetic to the medical injuries and difficulties that Plaintiffs have suffered. However, Plaintiffs’ FAC does not state a claim establishing that the CK Patch implanted in Plaintiff Donna Jager’s body for over a decade without incident, caused tortious injury to her in April 2015. Each of these causes of action and demand for punitive damages therefore 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 Plaintiffs’ CK Patch deviated from its intended design or differed from other seemingly identical units of the same model that 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 Plaintiffs have not alleged any misrepresentations made to Plaintiffs’ doctor either before or after the implant surgery, (5) the Fifth Cause of Action for Loss of Consortium fails because it is derivative and is dependent on the other claims that lack merit, and (6) the demand for punitive damages fails because Plaintiffs make conclusory allegations that do not meet the requirements set out in California Civil Code section 3294(a) and (b). Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 21 of 22 Page ID #:213 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’ 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 For these reasons, Defendants request that Plaintiffs’ FAC be dismissed with prejudice. DATED: November 28, 2016 REED SMITH LLP By: /s/ Michelle L. Cheng Michael K. Brown Marilyn A. Moberg Michelle L. Cheng Attorneys for Defendants US_ACTIVE-129486470 Case 5:16-cv-01424-JGB-KK Document 23-1 Filed 11/28/16 Page 22 of 22 Page ID #:214 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 - [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 DONNA JAGER and JOHN JAGER, Plaintiffs, vs. DAVOL INC.; BARD DEVICES, INC.; C.R. BARD; and DOES 1-10, inclusive, Defendants. Case No. 5:16-CV-01424-JGB-KK [PROPOSED] ORDER GRANTING DEFENDANTS DAVOL INC., BARD DEVICES, INC. AND C.R. BARD, INC.’S MOTION TO DISMISS FIRST AMENDED COMPLAINT Compl. Filed: July 1, 2016 FAC Filed: November 9, 2016 Hearing Date: February 13, 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-01424-JGB-KK Document 23-2 Filed 11/28/16 Page 1 of 2 Page ID #:215 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 Defendants Davol Inc., Bard Devices, Inc. and C. R. Bard, Inc.’s Motion to Dismiss Plaintiffs Donna and John Jager’s First Amended Complaint came on for hearing on February 13, 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 Plaintiffs’ 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 Plaintiffs’ 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 Court Judge Case 5:16-cv-01424-JGB-KK Document 23-2 Filed 11/28/16 Page 2 of 2 Page ID #:216