Eidson v. Medtronic, Inc. et al

MOTION to Dismiss Pursuant to Fed. R. Civ. P. 12

N.D. Cal.May 28, 2013

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 PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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) mkbrown@reedsmith.com Lisa M. Baird (SBN 179958) lbaird@reedsmith.com Mildred Segura (SBN 210850) msegura@reedsmith.com REED SMITH LLP 355 South Grand Avenue, Suite 2900 Los Angeles, CA 90071 Telephone:213.457.8000 Facsimile: 213.457.8080 Courtland C. Chillingworth (SBN 261140) cchillingworth@reedsmith.com REED SMITH LLP 101 Second Street, Suite 1800 San Francisco, CA 94105 Telephone:415.543.8700 Facsimile: 415.391.8269 Attorneys for Defendants Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA RICHARD EIDSON, Plaintiff, vs. MEDTRONIC, INC.; MEDTRONIC SOFAMOR DANEK USA, INC., Defendants. Case No. 4:13-cv-2049 Honorable Yvonne Gonzalez Rodgers DEFENDANTS MEDTRONIC, INC. AND MEDTRONIC SOFAMOR DANEK USA, INC.’S NOTICE OF MOTION AND MOTION TO DISMISS PURSUANT TO FED. R. CIV. P. 12(B)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEREOF Compl. Filed: May 6, 2013 Date: August 20, 2013 Time: 2:00 p.m. Place: Oakland Courthouse [Concurrently filed with Declaration of Mildred Segura, Request for Judicial Notice and [Proposed] Order] Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page1 of 25 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’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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. FACTUAL BACKGROUND .................................................................................................. 2 A. Congress “Swept Back” State Control Over Medical Devices And Imposed A Regime Of Detailed FDA Oversight ......................................................... 2 B. The FDA Granted Premarket Approval For The Infuse Device In 2002 .................... 3 C. The FDA Continues To Regulate And Monitor Devices Like The Infuse Device After They Receive Premarket Approval ........................................................ 5 D. Plaintiff’s Complaint Alleges That The Infuse Device’s FDA-Required Label, Design, And Manufacturing Were Deficient .................................................... 5 III. LEGAL ARGUMENT ............................................................................................................. 6 A. The Federal Standard For Motions To Dismiss Under Federal Rules Of Civil Procedure 12(b)(6) and 9(b) ................................................................................ 6 B. Riegel Requires The Dismissal Of Plaintiff’s Claims ................................................. 7 1. State-Law Claims That Would Impose Requirements Different From, Or In Addition To, Federal Law Are Expressly Preempted Under 21 U.S.C. § 360k(a) .............................................................................. 7 2. All Of Plaintiff’s Claims Are Expressly Preempted As A Matter Of Law .................................................................................................................. 8 3. Plaintiff Has Not Alleged A Valid “Parallel” Claim Under California Law ................................................................................................. 9 a. The Requirements For Stating A “Parallel Claim” ............................ 10 b. Off-Label Promotion Claims Are Not True Parallel Claims ............. 11 C. Plaintiff’s Claims Are Impliedly Preempted And Barred By 21 U.S.C. § 337(a) ...................................................................................................................... 13 D. Independent Grounds Also Bar Plaintiff’s Strict Liability-Design and Fraud-Based Claims ................................................................................................... 16 1. Plaintiff’s Strict Liability-Design Defect Claim Is Also Barred By The Restatement (Second) Of Torts Section 402A Comment k .................... 16 2. Plaintiff’s Fraud Claims Are Not Pled With The Requisite Particularity .................................................................................................... 16 IV. CONCLUSION ...................................................................................................................... 18 Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page2 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – ii – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 Cases Artiglio v. Superior Court, 22 Cal. App. 4th 1388 (1994) ......................................................................................................... 16 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ...................................................................................................................... 6, 7 Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) ........................................................................................................................ 10 Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) ...................................................................................................................... 6, 7 Brown v. Superior Court, 44 Cal. 3d 1049 (1988) ................................................................................................................... 16 Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) ................................................................................................................. passim Cabana v. Stryker Biotech, LLC, No. BC465313, 2012 WL 3876245 (Cal. Super. Aug. 20, 2012) ................................................... 12 General Dynamics C4 Systems, Inc., 637 F.3d 1047 (9th Cir. 2011) .................................................................................................... 7, 17 Caplinger v. Medtronic, Inc., ---F. Supp. 2d---, 2013 WL 453133 (W.D. Okla. Feb. 6, 2013) .............................................. passim Carson v. Depuy Spine, Inc., 365 Fed. App'x 812 (9th Cir. 2010, unpub.) ..................................................................................... 8 Cohen v. Guidant Corp., No. CV-05-8070, 2011 WL 637472 (C.D. Cal. Feb. 15, 2011) ............................................. 1, 8, 11 Coleman v. Medtronic Corp., No. SC112290, 2012 WL 2335532 (Cal. Super. Ct. June 13, 2012) .............................................. 12 Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005) ............................................................................................................ 7 Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085 (C.D. Cal. 2011) ................................................................................... passim Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011) .................................................................................................... 10, 11 Garrett v. Howmedica Osteonics Corp., 214 Cal. App. 4th 173 (2013) ......................................................................................................... 16 Heckler v. Chaney, 470 U.S. 821 (1985) ........................................................................................................................ 14 Heisner v. Genzyme Corp., No. 08-C-593, 2010 WL 894054 (N.D. Ill. Mar. 8, 2010) ............................................................. 10 Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y. 2009) ............................................................................................ 11 Hufft v. Horowitz, 4 Cal. App. 4th 8 (1992) ................................................................................................................. 16 Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page3 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – iii – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 Huggins v. Medtronic, Inc., No. 12CV40 (Colo. Dist. Ct. Feb. 21, 2013) .................................................................................. 12 Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582 (E.D.N.Y. 2009) ............................................................................................ 11 In re Actimmune Mktg. Litig., 614 F. Supp. 2d 1037 (N.D. Cal. 2009) .......................................................................................... 13 In re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig., 590 F. Supp.2d 1282 (C.D. Cal. 2008) ........................................................................................... 15 In re Medtronic Sprint Fidelis Leads Prods. Liab. Litig. (Bryant v. Medtronic, Inc.,), 623 F.3d 1200 (8th Cir. 2010) ...................................................................................................... 1, 9 Martinez v. Jeffrey Oppenheimer, M.D. et al., No. 12-31442 CA 06 (Fla. 11th Cir. Ct. Mar. 5, 2013) .................................................................. 12 Mat-Van, Inc. v. Sheldon Good & Co. Auctions, LLC, No. 07-CV-912, 2007 WL 3047093(S.D. Cal. Oct. 16, 2007) ....................................................... 17 McCormick v. Medtronic, Inc., Civil No. 368532 (Cir. Ct. Montgomery County, Md. Apr. 23, 2013) ........................................... 12 McLaughlin v. National Union Fire Ins. Co., 23 Cal. App. 4th 1132 (1994) ........................................................................................................... 5 McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 2005) .......................................................................................................... 10 Medtronic, Inc. v. Lohr,, 518 U.S. 480 (1996) ........................................................................................................................ 10 Parker v. Stryker Corp., 584 F. Supp. 2d 1298 (D. Colo. 2008) ............................................................................................ 11 Perez v. Nidek Co., Ltd., 711 F.3d 1109 (9th Cir. 2013) ................................................................................................. passim PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010) .......................................................................................................... 15 Plenger v. Alza Corp., 11 Cal. App. 4th 349 (1992) ........................................................................................................... 16 Raborn v. Albea, No. 583,675, 2012 WL 6600475 (La. Civ. D. Ct. Nov. 19, 2012) ................................................. 12 Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ................................................................................................................. passim Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minn. 2009) ......................................................................................... 6, 10 Simmons v. Boston Scientific Corp., No. CV 12-7962, 2013 WL 1207421 (C.D. Cal. Mar. 25, 2013) ............................................. 1, 8, 9 Smith v. Medtronic, Inc., CA No. 5:13-cv-0451 (W.D. La. May 16, 2013) ............................................................................ 12 States v. Caronia, 703 F.3d 149 (2d Cir. 2012) ....................................................................................................... 6, 12 Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) ........................................................................................ 8, 11, 12, 13 Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page4 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – iv – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 Telesaurus VPC, LLC v. Power, 623 F.3d 998(9th Cir. 2010), cert. denied, 132 S. Ct. 95 (2011) ...................................................... 6 Walker v. Medtronic, Inc., 670 F.3d 569(4th Cir. 2012), cert. denied, 133 S. Ct. 162 (2012) .................................................... 7 Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296 (11th Cir. 2011) ............................................................................................... passim Wolicki-Gables v. Arrow Int'l, Inc., 641 F. Supp. 2d 1270 (M.D. Fla. 2009) .......................................................................................... 15 Statutes 21 U.S.C. § 337(a) .......................................................................................................................... 3, 15 21 U.S.C. § 360c(a)(1)(C)(ii) .............................................................................................................. 16 21 U.S.C. § 360c(a)(2)(C)..................................................................................................................... 4 21 U.S.C. § 360e(d) .............................................................................................................................. 4 21 U.S.C. § 360e(d)(6)(A)(i) ................................................................................................................ 5 21 U.S.C. § 360k(a) .......................................................................................................................... 1, 3 21 U.S.C. § 360k(a)(1) ........................................................................................................................ 13 21 U.S.C. § 396 ..................................................................................................................................... 6 Rules Fed. R. Civ. Proc. 9(b) .......................................................................................................................... 7 Regulations 21 C.F.R. § 814.39(a), (c) ..................................................................................................................... 5 Other Authorities S. Rep. No. 33, 94th Cong., 2d Sess. 2 (1975) ..................................................................................... 3 Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page5 of 25 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 PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 August 20, 2013, at 2:00 p.m. or a date to be determined by the Court, the Honorable Yvonne Gonzalez Rodgers presiding, in the Oakland Courthouse of the above-entitled Court, Defendants Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. (collectively “Medtronic”) will move this Court for an order granting a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) in favor of Medtronic, on the ground that Plaintiff Richard Eidson’s Complaint fails to state any claims upon which relief can be granted. Medtronic’s motion to dismiss is made on the ground that each of Plaintiff’s state law tort claims in the Complaint are barred by the express preemption clause of the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 360k(a) as interpreted by the Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and are also impliedly preempted under Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), and prohibited by the “no private right of action” provision of the FDCA, 21 U.S.C. § 337(a). As a result, Plaintiff cannot state a claim against Medtronic and the Complaint should be dismissed with prejudice as to Medtronic. Three of Plaintiff’s causes of action are also barred under independently dispositive defenses. Plaintiff’s strict liability—design defect claim (Second Cause of Action) fails because California has adopted the Restatement (Second) of Torts § 402A Comment k, which precludes strict liability design defect claims for implanted prescription medical devices like the Infuse Device. Furthermore, Plaintiff’s fraud-based claims (First Cause of Action for “Fraudulent Misrepresentation and Fraud in the Inducement” and Fourth Cause of Action for “Strict Products Liability – Misrepresentation”) fail because they are not alleged with the requisite particularity under Federal Rules of Civil Procedure 9(b). // // // Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page6 of 25 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 PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 Medtronic’s Motion is based on this Notice of Motion and Motion, the Memorandum of Points and Authorities, Declaration of Mildred Segura and the Request for Judicial Notice filed herewith, and the pleadings and papers filed herein. Dated: May 28, 2013 REED SMITH LLP By /s/ Michael K. Brown Michael K. Brown Attorneys for Defendants Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page7 of 25 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 PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 I. INTRODUCTION Plaintiff Richard Eidson’s Complaint alleges that he was injured by a Class III medical device—Medtronic’s “Infuse Device”—whose design, manufacturing method, and labeling were specifically approved by the Food and Drug Administration (FDA) pursuant to the agency’s Premarket Approval (or PMA) process. Because Plaintiff’s claims against Medtronic would require a determination that the Infuse Device should have been designed, manufactured, or labeled differently from the manner required by the FDA, those claims are barred by the express preemption clause of the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 360k(a). As the Supreme Court explained in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), state tort claims are preempted when they would impose any requirement that is “different from, or in addition to” those imposed through the Premarket Approval process. 552 U.S. at 327-28 (citing 21 U.S.C. § 360k(a)). Numerous courts following Riegel have dismissed similar cases involving Premarket- Approved medical devices, including courts within the Ninth Circuit. See, e.g., Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1118-19 (9th Cir. 2013) (affirming preemption-based dismissal of fraud by omission claim); Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085, 1093-94 (C.D. Cal. 2011) (granting preemption-based motion for judgment on the pleadings); Simmons v. Boston Scientific Corp., No. CV 12-7962, 2013 WL 1207421, *4-*6 (C.D. Cal. Mar. 25, 2013) (same); Cohen v. Guidant Corp., No. CV-05-8070, 2011 WL 637472 at *1 (C.D. Cal. Feb. 15, 2011) (same). Because all of Plaintiff’s claims seek to impose state-law requirements on the design, manufacture, or labeling of the Infuse Device that are different from or in addition to those imposed by the FDA through the Premarket Approval process, § 360k(a) and Riegel compel dismissal. Plaintiff’s claims seek to enforce federal law and thus are also impliedly preempted under Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), and prohibited by the “no private right of action” provision of the FDCA, 21 U.S.C. § 337(a). The application of Riegel and Buckman create a “narrow gap” through which state law claims may survive; here, Plaintiff’s claims simply do not fit. See Perez, 711 F.3d at 1119 (citing In re Medtronic Sprint Fidelis Leads Prods. Liab. Litig. (Bryant v. Medtronic, Inc.), 623 F.3d 1200, 1204 (8th Cir. 2010) (“Bryant”)). Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page8 of 25 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 PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 allegations of “off-label” use and promotion do not change this analysis. The only federal district court to rule on a preemption motion involving the Infuse Device ruled, in a very detailed opinion, that all of the Plaintiff’s claims were both expressly and impliedly preempted. Caplinger v. Medtronic, Inc., ---F. Supp. 2d---, 2013 WL 453133, *10 (W.D. Okla. Feb. 6, 2013), reconsideration denied, 2013 WL 1411347 (W.D. Okla. Apr. 8, 2013) (“[P]laintiff’s off-label promotion allegations do not somehow turn plaintiff’s claims into ‘parallel’ claims that are not preempted.”) Finally, independent grounds also require dismissal of a number of Plaintiff’s claims. Plaintiff’s strict liability—design defect claim must be dismissed because California has adopted the Restatement (Second) of Torts § 402A Comment k, which precludes strict liability design defect claims for implanted prescription medical devices like the Infuse Device. Also, Plaintiff’s fraud claims must be dismissed because they are not alleged with the requisite particularity under Federal Rules of Civil Procedure 9(b). For all these reasons, Medtronic’s motion to dismiss should be granted. II. FACTUAL BACKGROUND For purposes of this motion, the relevant factual allegations are straightforward: (1) The medical device at issue is the Infuse Device. (See, e.g., Complaint ¶ 1); and (2) The Infuse Device is a Class III medical device approved by the FDA through the rigorous Premarket Approval process. (See, e.g., Complaint ¶ 55 (noting that the Infuse Device received Premarket Approval on July 2, 2002); see also Medtronic’s Request for Judicial Notice (“RJN”), Exhibit A, the Infuse Device Premarket Approval Database Listing, p. 1) Although these two background facts are all that is required to grant Medtronic’s motion to dismiss under the Supreme Court’s controlling authority, a more detailed regulatory history follows to provide this Court with additional context for the preemption issues at hand. A. Congress “Swept Back” State Control Over Medical Devices And Imposed A Regime Of Detailed FDA Oversight When Congress granted the FDA regulatory power over medical devices in 1976, it sought to “provide for the safety and effectiveness of medical devices” (90 Stat. 539), while simultaneously “encourag[ing] the[ ] research and development” of “sophisticated, critically important” devices. S. Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page9 of 25 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 PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 Rep. No. 33, 94th Cong., 2d Sess. 2 (1975). To achieve that regulatory balance, the MDA “swept back” state control over medical devices and “imposed a regime of detailed federal oversight” by the FDA. Riegel, 552 U.S. at 316. The MDA thus expressly preempts state-law requirements applicable to medical devices that are “different from, or in addition to” requirements established by the FDA [21 U.S.C. § 360k(a)], whether the state requirement is imposed via tort law or regulation. “State tort law that requires a manufacturer’s catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme. . . . A jury . . . sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.” Riegel, 552 U.S. at 324. Similarly, § 337(a)—which was enacted as part of the FDCA in 1938 and extended by the MDA to medical devices—establishes that there is no private right of action to enforce the MDA, and that, apart from certain suits initiated by the states, “all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. § 337(a). B. The FDA Granted Premarket Approval For The Infuse Device In 2002 Plaintiff’s Complaint alleges that Mr. Eidson’s surgeon implanted the Infuse Device on November 11, 2008 through spinal surgery in an off-label manner. (See Complaint ¶ 278) As initially approved by the FDA, the “Infuse Device” consists of two components with three parts: (1) a recombinant human bone morphogenetic protein-2 (“rhBMP-2”), (2) a collagen scaffold (that is, a sponge), and (3) a tapered metallic spinal fusion cage. (See RJN, Exhibit B, Premarket Approval Letter for the Infuse Device)1 The Infuse Device is a Class III medical device subject to the FDA’s rigorous Premarket Approval process, which applies to devices like the Infuse Device that are both truly innovative and present a potential for unreasonable risk of illness or injury, or are important to supporting or 1 While the FDA’s initial Premarket Approval specified the LT-Cage as the tapered metallic spinal fusion cage component, later-approved PMA Supplements authorized additional, alternative cages, the “InterFix” and the “InterFix RP.” (See RJN, Exhibit D, the FDA’s Premarket Approval Database Listing for PMA Supplement 004 for the Infuse Device) The FDA also has approved PMA Supplements for the Infuse Device in configurations without any cage. (Complaint, n.1; RJN, Exhibits E & F, Premarket Approval Letters for tibial and dental indications) Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page10 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – 4 – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 sustaining human life, or preserving human health. See Riegel, 552 U.S. at 317; Buckman, 531 U.S. at 344. The FDA “grants premarket approval only if it finds there is a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.’” Riegel, 552 U.S. at 318 (quoting 21 U.S.C. § 360e(d)). Premarket Approval “is federal safety review.” Id. at 323 (emphasis in original). The FDA thus closely scrutinizes applications for Premarket Approval, “‘weigh[ing] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.’” Riegel, 552 U.S. at 318 (quoting 21 U.S.C. § 360c(a)(2)(C)). On July 2, 2002, after nearly a year-and-a-half of review, the FDA granted Premarket Approval for the Infuse Device under PMA Number P000058. (RJN, Exhibit A, p. 1, Exhibit B, p. 1) Additionally, since the Infuse Device first received Premarket Approval, the FDA has approved forty-four supplements to its Premarket Approval. (RJN, Exhibit A, p. 2). The latest of these supplements was approved by the FDA on March 27, 2013. (RJN, Exhibit C, the FDA’s Premarket Approval Database Listing for PMA Supplement 053 for Infuse) Through this PMA process, the FDA required particular language on the Infuse Device label—language that informed surgeons that all approved components were to be used together, that safety and effectiveness for unapproved surgical techniques was not established, and that the Infuse Device unavoidably carried certain risks:  “The InFUSE™ Bone Graft component is inserted into the LT-CAGE™ Lumbar Tapered Fusion Device component to form the complete InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device. These components must be used as a system. The InFUSE™ Bone Graft component must not be used without the LT-CAGE™ Lumbar Tapered Fusion Device component.” (RJN Ex. G, at 1 (emphasis original))  “The LT-CAGE™ Lumbar Tapered Fusion Device component is sold separately from the InFUSE™ Bone Graft component, however, these two components must be used together. (Id. (emphasis original))  “The safety and effectiveness of the InFUSE Bone Graft component with other surgical implants, implanted at locations other than the lower lumbar spine, or used in surgical techniques other than anterior open or anterior laparoscopic approaches have not been established.” (Id. at 4) Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page11 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – 5 – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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. The FDA Continues To Regulate And Monitor Devices Like The Infuse Device After They Receive Premarket Approval After the FDA grants Premarket Approval to a device, its regulatory oversight does not end. For example, “[o]nce a device has received premarket approval, [federal law] forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Riegel, 552 U.S. at 319 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). To make such changes, a manufacturer must submit a Premarket Approval Supplement, which is subject to the same rigorous standards of review as the initial application, and can implement the proposed changes only after FDA approval. See id. (citing 21 C.F.R. § 814.39(a), (c)). The FDA has never revoked, withdrawn, or otherwise suspended the Premarket Approval for the Infuse Device and the FDA’s approval is in place to this day. (RJN, Exhibit A, reflecting the current Premarket Approval database listing for the Infuse Device) D. Plaintiff’s Complaint Alleges That The Infuse Device’s FDA-Required Label, Design, And Manufacturing Were Deficient Plaintiff’s Complaint pleads five2 causes of action against Medtronic in connection with its Infuse Device: fraudulent misrepresentation and fraud in the inducement (Complaint ¶¶ 283-295), strict products liability–failure to warn (id. ¶¶ 296-309), strict products liability–design defect (Id. ¶¶ 310-319), strict products liability–misrepresentation (Id. ¶¶ 320-328), and products liability– negligence (id. ¶¶ 329-339). Although variously styled, the gravamen of each claim is that Medtronic should have labeled, designed, or manufactured the Infuse Device in a manner different than required by federal law, or that Medtronic should have done something additional that federal law did not require. The Complaint also contains various allegations that the use of the Infuse Device in Plaintiff’s surgery was “off-label,” and that Medtronic promoted the Infuse Device for this off-label 2 Plaintiff’s Complaint lists “Punitive Damages” as a Sixth Cause of Action on the caption page, but it is not included as a cause of action in the body of the Complaint. (See Complaint, caption page and at p. 71, ¶¶ 340-49) In California, punitive damages are merely a remedy (McLaughlin v. National Union Fire Ins. Co., 23 Cal. App. 4th 1132, 1164 (1994)) and Plaintiff here has not sufficiently averred allegations to support it. These allegations also fail because all of the possible predicate claims are subject to dismissal. Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page12 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – 6 – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 use without adequately disclosing its alleged risks.3 See, e.g., Complaint ¶¶ 1, 285-286. But Medtronic did warn against implanting the device without the LT-Cage component or via a posterior, rather than anterior, surgical approach, as the original Infuse Device label specifically warned that the Infuse device “must not be used without the LT-Cage” and that the “[t]he safety and effectiveness of the InFUSE Bone Graft component … used in surgical techniques other than anterior … approaches have not been established.” (See RJN Ex. G, at 1, 4; Ex. H, at 2, 5) As explained below, however, these allegations of off-label use and promotion also do not save Plaintiff’s claims from preemption because (1) they still would require that Medtronic add to or change the FDA-mandated warning label of the Infuse Device when it is prohibited from doing so by federal law; and (2) the claims are an attempt to enforce federal law and pursue a private right of action barred by Buckman and § 337(a). III. LEGAL ARGUMENT A. The Federal Standard For Motions To Dismiss Under Federal Rules Of Civil Procedure 12(b)(6) and 9(b) Dismissal under Federal Rules of Civil Procedure 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, 679 (2009); Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007); see also Telesaurus 3 “Off-label” use of a medical device—i.e., “use of a device for some other purpose than that for which it has been approved by the FDA”—is an “accepted and necessary corollary” of the fact that the FDA does not regulate the practice of medicine. Buckman, 531 U.S. at 350. “[T]he FDA’s drug approval process generally contemplates that approved drugs”—and devices—“will be used in off-label ways.” States v. Caronia, 703 F.3d 149, 166 (2d Cir. 2012). This is because physicians are free to prescribe prescription devices for whatever purpose they judge their patients to need— regardless of whether the FDA has approved that indicated use for inclusion on the label. See Buckman, 531 U.S. at 341, 350. Indeed, the FDCA provides that it does not “limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” Id. at 350 (quoting 21 U.S.C. § 396); see also Perez, 711 F.3d at 1115 (quoting Buckman). Furthermore, as the Second Circuit has recognized, the FDCA “and its accompanying regulations do not expressly prohibit . . . off-label promotion.” Caronia, 703 F.3d at 160. The FDA “recognizes that the public health can be served when health care professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products.” See Riley v. Cordis Corp., 625 F. Supp. 2d 769, 782 n.2 (D. Minn. 2009). By contrast, any attempt to prohibit truthful off-label promotion “while simultaneously allowing off- label use ‘paternalistically’ interferes with the ability of physicians and patients to receive potentially relevant treatment information; such barriers to information about off-label use could inhibit, to the public’s detriment, informed and intelligent treatment decisions.” Caronia, 703 F.3d. at 166. Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page13 of 25 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 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 DEFE VPC, claim reaso It is “ recita “[t]hr do no legal 90. A circum 9(b). Syste appli to ple allega B. determ requi invol satisf as tha cert. (11th NDANTS’ NO FED. R. CIV. LLC v. Pow has facial p nable infere plaintiff’s o tion of the e eadbare rec t suffice.” I conclusion llegations o stances co Allegations ms, Inc., 637 es to claims ading with p tions do no Riegel Re St1. Ad The Sup ining if sta First, the rements app ving a devic y this first c t term is use denied, 133 Cir. 2011); TICE OF MO P. 12(b)(6); M er, 623 F.3d lausibility w nce that the bligation to lements of a itals of the e qbal, 556 U couched as a f fraud are nstituting fr of fraud als F.3d 1047, subject to R articularity t pass muste quires The ate-Law Cl dition To, reme Court te law claim court must d licable to” t e, such as th ondition. Id d in § 360k S. Ct. 162 ( Cupek v. M TION AND M EMORANDU 998, 1003 hen the pla defendant is provide . . . cause of ac lements of a .S. at 678. M factual alle subject to Ru aud or mista o must be fa 1055 (9th C ule 9(b) and , also plead r under thes Dismissal O aims That W Federal La in Riegel s are expres etermine w he particular e Infuse De . at 322 (“[p (a)); Walker 2012); Wolic edtronic, Inc – 7 – OTION TO D M OF POINT (9th Cir. 20 intiff pleads liable for th more than l tion will no cause of ac oreover, f gation.” Id le 9(b) heig ke shall be s cially plaus ir. 2011) (c stating that plausible all e federal ple f Plaintiff’ ould Imp w Are Expr establishe sly preempt hether “the medical de vice, that ha ]remarket a v. Medtron ki-Gables v ., 405 F.3d ISMISS PLA S AND AUTH 10), cert. de factual con e miscondu abels and co t do,” Twom tion, suppor ederal court .; see also E htened plea tated with p ible. Cafas onfirming th “claims of egations.”) ading stand s Claims ose Require essly Preem d a straigh ed under Se Federal Gov vice. Riege s received P pproval . . . ic, Inc., 670 . Arrow Int 421, 424 (6t INTIFF’S CO ORITIES IN nied, 132 S tent that allo ct alleged.” nclusions, a bly, 550 U. ted by mere s are “not bo rickson, 846 ding, which articularity so v. Genera at Iqbal’s p fraud or mis Plaintiff’s v ards. ments Diff pted Unde tforward t ction 360k( ernment has l, 552 U.S. a remarket A imposes [fe F.3d 569, 5 ’l, Inc., 634 h Cir. 2005 MPLAINT PU SUPPORT TH . Ct. 95 (201 ws the cour Iqbal, 556 nd a formul S. at 555, an conclusory und to acce F. Supp. 2d requires tha .” Fed. R. C l Dynamics lausibility r take… mus ague and co erent From r 21 U.S.C. wo-step pr a). established t 321. Clai pproval auto deral] ‘requ 73-74 (4th C F.3d 1296, 1 ). RSUANT TO EREOF 1). “A t to draw the U.S. at 678. aic d statements, pt as true a at 1089- t “the iv. Proc. C4 equirement t, in addition nclusory , Or In § 360k(a) ocedure fo ms matically irements’” ir. 2012), 300-01 r Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page14 of 25 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 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 DEFE woul 552 U “‘safe under 1224 2d at encom impo dutie (hold see a provi differ F. 3d becau 846 F witho dismi 2010 704 F state- satisf Steng strict NDANTS’ NO FED. R. CIV. Second, th d impose req .S. at 321; s ty and effec ” the Medic ,1233 (9th C 1091; Simm passing sta se state law s that differ ing that duti lso id. at 330 Subseque sion. Court ent or addit at 1118 (aff se Plaintiff’ . Supp. 2d a ut leave to a ss without l , unpub.) (af .3d at 1233 law duty tha ying that req el decision Al2. The FDA ly control its TICE OF MO P. 12(b)(6); M e court then uirements “ ee also id. a tiveness’” o al Device A ir. 2013) (en ons, 2013 W te common requirement from, or add es imposed (strict liabi nt case law h s in this circ ional require irming dism s claim “eff t 1093-94 (g mend); Coh eave to ame firming orde (certain clai t parallels a uirement no dismissing a l Of Plainti ’s Premarke design, ma TION AND M EMORANDU must deter different fro t 316 (citin r “any other mendments banc); Wo L 1207421 law tort theo s within the to, the duti through stat lity and neg as confirme uit have app ments on Pr issal of frau ectively see ranting pre en, 2011 W nd); Carson r granting p ms preempt federal-law t preempted ll state law ff’s Claims t Approval o nufacture, a – 8 – OTION TO D M OF POINT mine wheth m, or in add g § 360k(a) matter incl to the FDCA licki-Gables , *3; Cohen, ries, such a meaning of es mandated e common l ligence clai d the broad lied Riegel emarket-Ap d by omissi ks to write i emption-bas L 637472 at v. Depuy Sp reemption-b ed where th duty under ); accord S claims with Are Expre f the Infuse nd labeling. ISMISS PLA S AND AUTH er the plaint ition to” th and noting r uded in a re ); Stengel , 634 F.3d a 2011 WL 6 s strict liabi § 360k(a), a by federal aw tort claim ms preempte scope of th to reject stat proved med on claim on n a new prov ed motion f *1 (grantin ine, Inc., 36 ased summ e plaintiffs “ the MDA” w immons, 201 prejudice ba ssly Preemp Device imp Each of Pla INTIFF’S CO ORITIES IN iff’s state la ose establish equirements quirement a v. Medtronic t 1300-01; E 37472 at *1 lity and neg nd are pree law. Riegel s constitute d). e MDA’s ex e-law claim ical devices express pre ision to the or judgment g preemptio 5 Fed. App ary judgmen have not sp hile other 3 WL 1207 sed on expr ted As A M oses federa intiff’s clai MPLAINT PU SUPPORT TH w causes of ed by the F must relate pplicable to , Inc., 704 F rickson, 84 . Claims ligence, auto mpted if the , 552 U.S. a state “requ press preem s seeking to . See e.g., P emption gro FDCA”); E on the plea n-based mo ’x 812, 813- t); see also ecified in th Arizona law 421, *4-*6 ess preempt atter Of L l “requireme ms depends RSUANT TO EREOF action DA. Riegel to either the device .3d 6 F. Supp. matically y impose t 324-25 irements”); ption impose erez, 711 unds rickson, dings tion to 15 (9th Cir. Stengel, ose claims a claims (post- ion). aw nts” that on a finding , Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page15 of 25 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 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 DEFE that t mann 552 U liabil labeli 4531 preem shoul off-la his cl NDANTS’ NO FED. R. CIV. he Infuse De er approved .S. at 320 ( ity; breach o ng, marketin 33, at *13 (c pted under  Strict allege those Simmo with p *14 (I  Strict square ‘requi [PMA 1206 ( 1093- 45313  Produ claim neglig Devic neglig same)  Fraud 283-2 Plaint have b warnin 1094 ( (Infus In short, P d be dismiss Pl3. Plaintiff’s bel promoti aims rest on TICE OF MO P. 12(b)(6); M vice should by the FDA affirming di f implied w g, and sale” laims relate § 360k(a)”) Products Li s that Medtr required by ns, 2013 W rejudice bas nfuse Devic Products Li ly holds tha rement[s]’ a -approved] affirming d 94 (dismissi 3, *13 (Infu cts Liability is preempte ence law, th e was defect ence claim) . ulent Misre 95) and Stri iff’s fraud-b een labeled gs. Such c dismissing e Device ca laintiff has ed without aintiff Has Complaint on. (See Co state law du TION AND M EMORANDU have been d and, accord smissal on g arranty; and of a Prema d to the Infu . In particul ability – Fa onic should the FDA, an L 1207421, ed on expre e case; same ability – De t “common- nd [are] pre medical dev ismissal of d ng strict liab se Device c – Negligen d because it e FDA-appr ive. See e.g ; Caplinger, presentatio ct Products ased claims differently, laims are pr fraud claims se; same). failed to ple leave to ame Not Alleged rests on alle mplaint ¶¶ ties that me – 9 – OTION TO D M OF POINT esigned, m ingly, is ex round that t negligence rket-Approv se Device a ar: ilure To Wa have given d such a cla *5 (dismiss ss preempti ). sign Defect law causes -empted by ice.” 552 U esign defec ility design ase; same). ce (Compla would requ oved manuf ., Erickson, 2013 WL 4 n And Frau Liability – M are premise or that Med eempted. Se ); see also C ad any claim nd as a resu A Valid “P gations that 129-131) Pr rely “‘paral ISMISS PLA S AND AUTH anufactured pressly pree he “MDA p in the desig ed device); re “the exac rn (Compla different or im is plainly ing strict lia on); Capling (Complaint of action for federal requ .S. at 332; s t claim); Eri defect claim int ¶¶ 329-3 ire a finding acturing, de 846 F. Supp 53133, *14- d In The In isrepresen d on the ass tronic shoul e, e.g., Eric aplinger, 2 s that are n lt. arallel” Cl Medtronic v esumably h lel,’ rather t INTIFF’S CO ORITIES IN , or labeled d mpted unde re-empt[s] . n, testing, in see also Ca t type of cla int ¶¶ 296- additional w preempted bility failur er, 2013 W ¶¶ 310-319 …strict liab irements sp ee also Brya ckson, 846 ); Caplinge 39): Plainti that, as a m sign, and la . 2d at 1093 *15 (Infuse ducement ( tation (Id. ¶ ertion that th d have prov kson, 846 F 013 WL 453 ot preempte aim Under iolated fede e does so in han differ fr MPLAINT PU SUPPORT TH ifferently fr r § 360k(a). . . claims of spection, di plinger, 201 im that is ex 309): Plaint arnings, be . See, e.g., e to warn cla L 453133, * ): Riegel ility do imp ecific to a nt, 623 F.3 F. Supp. 2d r, 2013 WL ff’s negligen atter of state bel of the In -94 (dismis Device case Complaint ¶ ¶ 320-328) e device sh ided additio . Supp. 2d a 133, *10-* d, and his c California ral law by e an effort to om or add to RSUANT TO EREOF om the See Riegel strict stribution, 3 WL pressly iff yond im 12- ose d at at ce fuse sing ; ¶ : ould nal t 16 laims Law ngaging in suggest that , federal , Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page16 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – 10 – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 requirements” and therefore escape preemption under Section 360k(a). Riegel, 552 U.S. at 330. As shown below, Plaintiff has not alleged a valid “parallel” claim. a. The Requirements For Stating A “Parallel Claim” Because Riegel held that medical device preemption results only when a state law claim imposes requirements that are “different from, or in addition to” federal Premarket Approval requirements, courts have acknowledged that a very narrow exception may exist when the plaintiff asserts a state law claim that imposes duties that “parallel” the federal requirements imposed through the Premarket Approval process. The Supreme Court has explained that a state law cause of action would not be expressly preempted under 21 U.S.C. § 360k(a) if it imposed duties that are “identical” to those imposed by federal law applicable to the medical device in question. Medtronic, Inc. v. Lohr, 518 U.S. 480, 495 (1996). Echoing Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), the Eleventh Circuit has explained (in an off-label promotion case) that: In order for a state requirement to be parallel to a federal requirement, and thus not expressly preempted under § 360k(a), the plaintiff must show that the requirements are “genuinely equivalent.” State and federal requirements are not genuinely equivalent if a manufacturer could be held liable under the state law without having violated the federal law. Wolicki-Gables, 634 F.3d at 1300 (quoting McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005); in turn quoting Bates, 544 U.S. at 454 (emphasis in original)). Thus, as courts around the country have explained, to state a true parallel claim, the complaint must allege a specific and pre-existing state-law tort theory that makes the predicate federal regulatory violation actionable while imposing no different or additional duties on the manufacturer. See Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011); McMullen, 421 F.3d at 488-89; Riley, 625 F. Supp. 2d at 777 (“the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law—and that would give rise to liability under state law even if the FDCA had never been enacted”); Heisner v. Genzyme Corp., No. 08-C-593, 2010 WL 894054, at *4 (N.D. Ill. Mar. 8, 2010) (“failure to report adverse events to the Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page17 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – 11 – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 FDA” theory may describe an FDCA violation, but it does not constitute a viable product liability theory under state law). Many courts also require that the complaint show that the plaintiff’s alleged injuries are causally linked to the alleged deviation from a federal requirement that the plaintiff seeks to remedy through the parallel state-law claim. See Wolicki-Gables, 634 F.3d at 1301-02 (no parallel claim because plaintiff did not “‘set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged.”) (quoting Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 589 (E.D.N.Y. 2009)); Funk, 631 F.3d at 782; Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 282-83 (E.D.N.Y. 2009); Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 1301 (D. Colo. 2008) (preemption barred plaintiff’s claims where plaintiff failed to demonstrate causal connection between alleged defect and plaintiff’s injury or that defendant’s alleged violation of federal regulations rendered device defective); Cohen, 2011 WL 637472, *1 (“[i]n order for Plaintiff to plead properly parallel claims that survive preemption under Riegel, he must demonstrate facts . . . establishing a causal nexus between the alleged injury and the violation.”); but see Stengel, 704 F.3d at 1235 (Watford, J., concurring) (stating that causation was a requirement for the proof, rather than the pleading stage). b. Off-Label Promotion Claims Are Not True Parallel Claims Off-label promotion claims involving the Infuse Device do not meet this parallel claim test, and the Caplinger decision by the Chief Judge of the Western District of Oklahoma provides a clear roadmap for the analysis. See Caplinger, 2013 WL 453133, at *10-*16 (plaintiff failed to allege a parallel claim in an Infuse Device case alleging off-label promotion). As to fraud and failure-to- warn claims asserting that the manufacturer failed to disclose risks of off-label uses, allowing these claims “would permit a finding that defendants were required to alter the Infuse Device’s warning and label and to provide additional warnings above and beyond those on the Infuse Device's label and accompanying the device—a label and warnings that were specifically approved by the FDA as part of the PMA process.” Id. at *10, *13, *15-*16. Claims that the “Infuse Device was defective and unreasonably dangerous,” or had a design defect when used off-label, or was “not safe and effective” similarly contradict the Premarket Approval and would impose different or additional Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page18 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – 12 – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 requirements. Id. at *12, *13-*14. Moreover, Caplinger also specifically concluded “that [a] federal requirement that manufacturers not promote devices for off-label uses is not genuinely equivalent to the state law requirement that a manufacturer provide adequate warnings to physicians about the risks of its medical device . . . [i]t is possible to violate the state law while comply with the federal requirement and vice versa.” Id. at *10 n.4. Not surprisingly, Caplinger’s analysis has been adopted in a subsequent Infuse Device case as well. See McCormick v. Medtronic, Inc., Civil No. 368532 (Cir. Ct. Montgomery County, Md. Apr. 23, 2013) (characterizing the Caplinger’s analysis as “flawless” and granting preemption-based motion to dismiss in an Infuse Device case where plaintiffs alleged off-label promotion) (Declaration of Mildred Segura, Exhibit 1, Order and Hearing Transcript at p. 76).4 Medtronic nevertheless anticipates that Plaintiff may argue that Stengel supports the denial of Medtronic’s Motion to Dismiss. It does not. Stengel concluded that a failure to warn claim under Arizona law imposed duties that were parallel to federal adverse event reporting regulations, neither of which are at issue in this case. See Stengel, 704 F.3d at 1232-33. As to the allegedly parallel federal violation that is at issue here, no express federal statute or regulation prohibits off-label promotion. The FDCA “and its accompanying regulations do not expressly prohibit . . . off- label promotion.” Caronia, 703 F.3d at 160. And on the state-law side of the parallel claim equation, Plaintiff has not pointed to any state law authority imposing liability for off-label 4 See Raborn v. Albea, No. 583,675, 2012 WL 6600475, *1 (La. Civ. D. Ct. Nov. 19, 2012) (dismissing as expressly preempted Infuse-related claims similar to those asserted here because they would “impose state-law requirements on a medical device that are different from, or in addition to, those required by the [FDA]”); Coleman v. Medtronic Corp., No. SC112290, 2012 WL 2335532 (Cal. Super. Ct. June 13, 2012) (dismissing with prejudice Infuse-related claims such as those asserted here because “Plaintiff would require Defendant to give warnings different from, or in addition to, those required by the FDA”); see also Smith v. Medtronic, Inc. CA No. 5:13-cv-0451 (W.D. La. May 16, 2013) (granting Motion to Dismiss in Infuse-related case, but allowing Plaintiff opportunity to amend complaint “to clarify her remaining causes of action for the promotion and marketing of off label use of a device”). In contrast, where state court cases involving the Infuse Device have been allowed to proceed, the analysis has been far less rigorous than that by the Caplinger court. Cabana v. Stryker Biotech, LLC, No. BC465313, 2012 WL 3876245 (Cal. Super. Aug. 20, 2012) (finding some triable issues but noteworthy in that it also resulted in the voluntary dismissal of many of plaintiff’s claims, including all claims for strict product liability: design defect, manufacturing defect and failure to warn, as well as the plaintiff’s breach of implied warranty claim); Huggins v. Medtronic, Inc., No. 12CV40 (Colo. Dist. Ct. Feb. 21, 2013) (denying preemption-based Motion to Dismiss but providing no analysis); Martinez v. Jeffrey Oppenheimer, M.D. et al., No. 12-31442 CA 06 (Fla. 11th Cir. Ct. Mar. 5, 2013) (denying preemption-based Motion to Dismiss but providing no analysis). Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page19 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – 13 – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 promotion, and—to the extent Plaintiff might point to a misrepresentation or failure to warn claim— off-label promotion is not inherently misleading simply because the use is off-label particularly where, as here, the label was approved by the FDA through the Premarket Approval process. See In re Actimmune Mktg. Litig., 614 F. Supp. 2d 1037, 1051, n.6 (N.D. Cal. 2009). In circumstances like here, Stengel confirms that under Riegel, state tort claims are expressly preempted “to the extent that they are ‘different from, or in addition to’ the requirements imposed by federal law.” Stengel, 704 F.3d at 1230 (quoting Riegel, 552 U.S. at 330). Moreover, following Stengel, the Ninth Circuit itself addressed how off-label claims should be evaluated in the express preemption context. In Perez, the plaintiffs alleged that the defendant had promoted the device at issue for off-label uses, and pointed to an FDA “warning letter” faulting the defendant’s employees for modifying the device (in violation of PMA) so that it could be used off-label. Perez, 711 F.3d at 1113. The plaintiffs asserted a claim for fraud by omission, alleging that the defendants had misled them by failing to disclose that the device was not FDA approved for the off-label use. Id. at 1117. Yet the Ninth Circuit affirmed dismissal of the fraud by omission claim on the grounds of express preemption because the plaintiffs’ claim would add a disclosure requirement “‘different from, or in addition to’ the requirements applicable to the [device] under the MDA.” Id. at 1118 (quoting 21 U.S.C. § 360k(a)(1)). Plaintiff’s off-label promotion allegations— allegations not at issue in Stengel, but present in Perez—fall short of what is required to state a valid parallel claim. C. Plaintiff’s Claims Are Impliedly Preempted And Barred By 21 U.S.C. § 337(a) Even if allegations of off-label promotion or some alleged violation of federal requirements could save Plaintiff’s claims from express preemption, his claims would still be impliedly preempted under Buckman and barred by 21 U.S.C. § 337(a). See Caplinger, 2013 WL 543133, *15 (“to the extent that plaintiff’s negligence claim is based upon defendants’ promotion and marketing of the Infuse Device for off-label uses, the Court finds it is impliedly preempted under Buckman and § 337(a).”). Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page20 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – 14 – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 In Buckman, the Supreme Court concluded that “fraud-on-the-FDA” claims were impliedly preempted by the MDA because they improperly infringed upon the FDA’s regulatory authority. Buckman, 531 U.S. at 347-48. In reaching that conclusion, the Supreme Court noted its profound concern that permitting state tort claims to proceed when they were based upon a duty that existed solely by virtue of the federal statutory scheme would upset the regulatory balancing and were, thus, impliedly preempted. Id. at 350-51. The Court advanced a number of reasons why that was so, including: the risk of infringing on the FDA’s broad discretion to police violations of its regulations as it sees fit. Id.; see also Heckler v. Chaney, 470 U.S. 821, 835 (1985) (emphasizing the importance of the FDA’s “complete discretion” in deciding “how and when [its enforcement tools] should be exercised.”). The fact that the obligation to submit the requisite information to the FDA was solely a product of the federal regulatory scheme was another. Buckman, 531 U.S. at 350-51. The Court foresaw that state tort claims would exercise an “extraneous pull” on the regulatory scheme and concluded that resulting interference with the federal regulatory scheme meant that such claims were impliedly preempted. Id. at 353. In Perez, the Ninth Circuit held that the fraud claim based on alleged off-label promotion allegations was also impliedly preempted. In so holding, the court determined that an off-label based “fraud by omission claim ‘exist[s] solely by virtue of the FDCA…requirements,’ with respect to approved use of the [medical device].” Perez, 711 F.3d at 1119 (citation omitted). The Court reasoned that off-label use is a concept entirely derived from the FDCA, and “[l]ike the fraud-on- the-FDA claims in Buckman, [plaintiffs’] fraud by omission claim ‘exist[s] solely by virtue of the FDCA . . . requirements’ . . . [and] ‘the existence of these federal enactments is a critical element in their case.’” Id. (quoting Buckman, 531 U.S. at 353). Thus, by seeking to impose liability for any potential alleged violation of purported federal regulations relating to off-label promotion [e.g., Complaint, ¶¶ 141-150, 331(c)], Plaintiff is either (1) trying to usurp the FDA’s regulatory oversight role for policing purported violations of the agency’s regulations; or (2) basing his various tort claims solely on a violation of federal law. Either way, Plaintiff’s claims run headlong into Buckman’s implied preemption principles. Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page21 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – 15 – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 In addition to the obstacles created by Buckman, to the extent Plaintiff seeks to base his tort claims on an alleged violation of the FDCA or implementing regulation, those claims are barred by 21 U.S.C. § 337(a). Stengel did not examine this “no private right of action” requirement, yet the Supreme Court has held that it “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance” with federal law. Buckman, 531 U.S. at 349 n.4 (citing 21 U.S.C. § 337(a)). Courts thus reject plaintiffs’ efforts to enforce federal requirements regarding off-label promotion under § 337(a), because any effort by a plaintiff to fashion a state-law cause of action out of any alleged federal statutory violation with no counterpart in established state law is an attempt at private enforcement of the FDCA barred by § 337(a). See, e.g., PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 924 (9th Cir. 2010) (citing Buckman and section 337(a), and noting that claims under state law theories are preempted where such “claims collide with the exclusive enforcement power of the federal government”); Wolicki-Gables v. Arrow Int’l, Inc., 641 F. Supp. 2d 1270, 1292 (M.D. Fla. 2009) (recognizing that, even if the plaintiff had evidence of off-label promotion or marketing “there is no private right of action for violations of the FDCA”), aff’d 634 F.3d 1296 (11th Cir. 2011); In re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig., 590 F. Supp.2d 1282, 1292 (C.D. Cal. 2008) (“insofar as Plaintiffs’ claims are based solely on allegations that Defendants promoted [the prescription drug] for off-label purposes, they constitute an impermissible attempt to bring a private suit for violations of the FDCA”). In short, there is no pre-existing state-law duty to abstain from off-label promotion; these duties and concepts are alien to state law and the distinction between on-label and off-label uses is a creature of federal law that exists only within, and by virtue of, the federal regulatory scheme. See Buckman, 531 U.S. at 350. Thus, Plaintiff is seeking to hold Medtronic liable for conduct that was not unlawful under “traditional state tort law which had predated the federal enactment,” and attempting to pursue claims that include as a “critical element” something that “exist[s] solely by virtue” of the FDCA. Id. at 353. Any such a claim is squarely precluded. Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page22 of 25 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 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 DEFE D. adopt manu tradit be lia or kn drugs devic Corp (1992 In oth are “p which unrea (quot that c distri liabil fraud partic averm partic NDANTS’ NO FED. R. CIV. Independ Claims Pl1. Re Plaintiff’s ed the Resta facturers of ional tort th ble if they a owable dang ); Garrett v e); Artiglio ., 11 Cal. Ap ) (same). T er words, it Medical d urported or is of substa sonable risk ations omitt an only be s bution, and ity design de Pl2. Plaintiff a in the induc ularity as re ents of frau ularity.” Ru TICE OF MO P. 12(b)(6); M ent Ground aintiff’s Str statement strict liabil tement (Sec prescription eories in cas re found to ers. See Br . Howmedic v. Superior p. 4th 349, his blanket applies to a evices like t represented ntial impor of illness o ed). Furthe old to physi use of this d fect claim i aintiff’s Fra lleges two c ement” and quired by F d or mistak le 9(b) requ TION AND M EMORANDU s Also Bar ict Liability (Second) O ity design de ond) of Tor medical de es not invol have improp own v. Supe a Osteonics Court, 22 Ca 360-361 (19 rule does no ll such devic he Infuse D to be for a u tance in prev r injury.” R rmore, the I cians or hos evice are re s barred und ud Claims auses of act “strict liabi ederal Rules e, the circum ires a plaint – 16 – OTION TO D M OF POINT Plaintiff’s -Design De f Torts Sect fect claim i ts § 402A C vices under ving preemp erly manufa rior Court, Corp., 214 C l. App. 4th 92) (same); t require a c es. Hufft, 4 evice fall w se in suppo enting imp iegel, 552 U nfuse Devic pitals. (RJN stricted to p er Californi Are Not Pl ion based in lity-misrepr of Civil Pro stances con iff to specif ISMISS PLA S AND AUTH Strict Liabi fect Claim ion 402A C s barred by omment k, w a design def tion, a med ctured a dev 44 Cal. 3d 1 al. App. 4t 1388, 1397 Hufft v. Ho ase-by-case Cal. App. a ithin Comm rting or sust airment of h .S. at 317 (c e is a prescr , Exhibit B, rescription a law. ed With Th fraud—“fra esentation”— cedure 9(b) stituting fra ically state t INTIFF’S CO ORITIES IN lity-Design Is Also Bar omment k California la hich preclu ect theory. ical device m ice or faile 049, 1061 ( h 173, 178 ( (1994) (sam rowitz, 4 Ca analysis of t 19. ent k, becau aining hum uman health iting § 360c iption impla p. 1 (stating use.”)) Thu e Requisite udulent mis but neither . Pursuant ud or mistak he circumst MPLAINT PU SUPPORT TH and Fraud red By The w. Californ des liability Rather, und anufacture d to warn of 1988) (presc 2013) (impl e); Plenger l. App. 4th the device’s se by defini an life or for , or present (a)(1)(C)(ii nted medica “The sale, s, Plaintiff’s Particular representati of them are to Rule 9(b) e shall be s ances surrou RSUANT TO EREOF -Based ia has for er r can only its known ription anted v. Alza 8, 11 & 20 purpose. tion, they a use s a potential )) l device strict ity on and pled with , “in all tated with nding an Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page23 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – 17 – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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 alleged fraud. See Cafasso, 637 F.3d at 1055 (stating that “claims of fraud or mistake… must, in addition to pleading with particularity, also plead plausible allegations.”); Erickson, 846 F. Supp. 2d at 1093 (in addition to finding plaintiff’s fraud-based claims preempted, the Court also held that the fraud-based claims were not plead with particularity because “the Complaint does not allege the specific content of these misrepresentations. Nor does the Complaint allege when and where the misrepresentations were made, or who made them.”); see also Caplinger, 2013 WL 453133, at *11- 12 (Infuse Device case; fraud claims dismissed because they were not pled with the particularity required under Rule 9(b)). Moreover, because corporations speak through agents, allegations that a corporation or its “agents” committed fraud or made misrepresentations are generally insufficient, and the specific identity of the agent must be alleged for purposes of Rule 9(b). See Mat-Van, Inc. v. Sheldon Good & Co. Auctions, LLC, No. 07-CV-912, 2007 WL 3047093, *4 (S.D. Cal. Oct. 16, 2007) (dismissing plaintiff’s fraud claim where plaintiff did not allege that individual making allegedly fraudulent statements was acting as agent for defendant). Nowhere has Plaintiff pled the specific circumstances surrounding any alleged misrepresentations or omissions made by Medtronic. Therefore, in addition to being barred by preemption, Plaintiff’s fraud-based claims must be dismissed because they are not pled with the requisite particularity. /// /// /// /// /// /// /// /// /// /// Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page24 of 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 – 18 – DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(b)(6); MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT THEREOF 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. CONCLUSION Innovative medical devices carry risks. The FDA-imposed requirements manage—but do not eliminate—those risks. Even with these risks, the preemption defense still applies. The Infuse Device implanted in Plaintiff had Premarket Approval, yet Plaintiff’s causes of action would require Medtronic to use a warning label, design, or manufacturing process different from those required by federal law. All of Plaintiff’s claims against Medtronic accordingly are preempted and must be dismissed. Dated: May 28, 2013 REED SMITH LLP By /s/ Michael K. Brown Michael K. Brown Attorneys for Defendants Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. Case5:13-cv-02049-LHK Document9 Filed05/28/13 Page25 of 25