Breaux v. Globus Medical Inc

MOTION to Dismiss For Failure to State a Claim

W.D. La.August 19, 2016

UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF LOUISIANA LAFAYETTE-OPELOUSAS DIVISION PAUL BREAUX VERSUS GLOBUS MEDICAL, INC., ET AL. : : : : : : CIVIL ACTION NO. 6:16-cv-00872-DDD-CBW CHIEF JUDGE DEE D. DRELL MAGISTRATE JUDGE CAROL B. WHITEHURST ****************************************************************************** DEFENDANTS’ RULE 12(B)(6) MOTION TO DISMISS PLAINTIFF’S COMPLAINT NOW INTO COURT, through undersigned counsel, comes Defendants Globus Medical, Inc. and Globus Medical North America, Inc. (hereinafter collectively, “Defendants”), and pursuant to Fed. R. Civ. P. 12(b)(6), respectfully move the Court for entry of an Order dismissing the Complaint filed by Plaintiff Paul Breaux on the following grounds: 1. Plaintiff’s Complaint fails to state a claim upon which relief can be granted because Plaintiff’s products liability claims are expressly preempted by the Medical Device Amendments to the Food, Drug and Cosmetic Act 21 U.S.C. § 360k(a); 2. Plaintiff also fails to allege facts sufficient to support any claim against the Defendants under Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955 (2007); and 3. Plaintiff’s negligence claims are preempted, fail due to the exclusivity of the Louisiana Products Liability Act and also fail to state a claim. As set forth more fully in the attached Memorandum in Support, each of Plaintiff’s asserted causes of action should be dismissed with prejudice and on the merits, at Plaintiff’s costs. Case 6:16-cv-00872-DDD-CBW Document 10 Filed 08/19/16 Page 1 of 2 PageID #: 51 2 Respectfully submitted: BY: /s/ Andrew L. Plauché, Jr. ANDREW L. PLAUCHÉ, JR (# 11023) ELIZABETH B. CARVILLE (#27949) Plauché Maselli Parkerson LLP 701 Poydras Street, Suite 3800 New Orleans, Louisiana 70139 Telephone: 504-582-1142 Fax: 504-582-1172 Email: aplauche@pmpllp.com E-mail:acarville@pmpllp.com Denise B. Bense (Admitted Pro Hac Vice) Cozen O’Connor One Liberty Place 1650 Market Street Philadelphia, PA 19103 Telephone: 610-832-8351 Fax: 877-836-0584 E-mail:dbense@cozen.com COUNSEL FOR GLOBUS MEDICAL, INC. and GLOBUS MEDICAL NORTH AMERICA, INC. Case 6:16-cv-00872-DDD-CBW Document 10 Filed 08/19/16 Page 2 of 2 PageID #: 52 PAUL BREAUX VERSUS GLOBUS MEDICAL, INC., ET AL. : : : : : : CIVIL ACTION NO. 6:16-cv-00872-DDD-CBW CHIEF JUDGE DEE D. DRELL MAGISTRATE JUDGE CAROL B. WHITEHURST ****************************************************************************** MEMORANDUM IN SUPPORT OF DEFENDANTS’ RULE 12(B)(6) MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM Respectfully submitted: BY: /s/ Andrew L. Plauché, Jr. ANDREW L. PLAUCHÉ, JR (# 11023) ELIZABETH B. CARVILLE (#27949) Plauché Maselli Parkerson LLP 701 Poydras Street, Suite 3800 New Orleans, Louisiana 70139 Telephone: 504-582-1142 Fax: 504-582-1172 Email: aplauche@pmpllp.com E-mail:acarville@pmpllp.com Denise B. Bense (Admitted Pro Hac Vice) Cozen O’Connor One Liberty Place 1650 Market Street Philadelphia, PA 19103 Telephone: 610-832-8351 Fax: 877-836-0584 E-mail:dbense@cozen.com COUNSEL FOR GLOBUS MEDICAL, INC. and GLOBUS MEDICAL NORTH AMERICA, INC. Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 1 of 27 PageID #: 53 i TABLE OF CONTENTS I. INTRODUCTION .................................................................................................................. 1 II. FACTUAL BACKGROUND ................................................................................................. 2 A. The Globus SECURE-C and Plaintiff’s Surgery. ............................................................... 2 B. The FDA Premarket Approval Process Determines Safety and Efficacy and the FDA Continues To Monitor and Regulate PMA Devices...................................... 3 C. The Globus SECURE-C Received FDA Premarket Approval. .......................................... 4 D. Plaintiff’s Causes of Action Are Preempted. ...................................................................... 5 III. LEGAL ARGUMENT ............................................................................................................ 7 A. Legal Standard for Granting A Motion to Dismiss Under Federal Rule of Civil Procedure 12(b)(6). .................................................................................................... 7 B. Federal Preemption Bars Plaintiff’s Claims Against Globus. ............................................ 8 1. Plaintiff’s Claims are Expressly Preempted by the MDA. ............................................. 8 2. Plaintiff’s LPLA State Law Claims are Preempted. ..................................................... 12 C. Plaintiff’s Claims Are Preempted By The MDA But The Complaint Also Fails to Allege Facts Sufficient to Support Any Claim Against Globus. ......................... 13 D. Plaintiff’s Negligence Claims Of a Failure to Instruct/Educate Are Preempted By The MDA, But Also Fail Due to the Exclusivity of the LPLA and Their Failure to State a Claim..................................................................................................... 17 IV. CONCLUSION ..................................................................................................................... 19 Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 2 of 27 PageID #: 54 ii TABLE OF AUTHORITIES Page(s) Cases Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) .....................................................................................................9 Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955 (2007) ..............................................................................................2, 13, 14, 15 Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) ...................................................................................................7, 8, 13, 14 Bencomo v. Guidant Corp., 2008 WL 3364960 (E.D. La. Aug. 8, 2008) ............................................................................16 Bencomo v. Guidant Corp., 2009 WL 1951821 (E.D. La. June 30, 2009) ...........................................................................10 Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) ...................................................................................................................1 Butler v. La. State Univ. Health Sci. Ctr., No. 12-CV-1838, 2012 WL 3263888 (W.D. La. Aug. 9, 2012) ..............................................17 Callaway v. Am. Med. Sys., Inc., CIV.A. 11-00193, 2011 WL 7724268 (W.D. La. Dec. 8, 2011) .............................................13 Cenac v. Hubbell, 2010 WL 4174573 (E.D. La. Oct 21, 2010) ......................................................................10, 12 Cohen v. Guidant Corp., 2011 WL 637472 (C.D. Cal. Feb. 15, 2011)............................................................................10 Couvillier v. Allergan Inc., 2011 U.S. Dist. LEXIS 12919 (W.D. La. Feb 9, 2011) .............................................................9 Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009) ..........................................................................10 Cuvillier, 503 F.3d at 401 ..............................................................................................................13 Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011) ...........................................................................................7, 9, 15 Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 3 of 27 PageID #: 55 iii Godfrey v. Advanced Neuromodulation Systems, Inc, 2011 WL 7768092 (5th Cir. 2011) ................................................................................4, 11, 12 Gomez v. St. Jude Medical Daig Division, Inc., 442 F.3d 919 (5th Cir. 2006) ...................................................................................2, 10, 12, 18 Guidry v. Aventis Pharmaceuticals, Inc., 418 F.Supp.2d 835 (M.D. La. 2006) ........................................................................................16 Hall v. Horn Medical, LLC, 2012 WL 1752546 (E.D.La.2012) ...........................................................................................19 Harris v. Danek Med., Inc., 1999 U.S. Dist. LEXIS 18893 (M.D. La. July 21, 1999) ........................................................17 Hinkel v. St. Jude Medical, S.C., 869 F. Supp. 2d 739 (E.D. La. 2012) .......................................................................................12 Hughes v. Boston Scientific Corp., 631 F. 3d 762 (5th Cir. 2011) ....................................................................................................9 Ivory v. Pfizer, 2009 WL 3230611 (W.D. La. Sept. 30, 2009) .........................................................................16 Jacobsen v. Wyeth, LLC, No. 10-0823, 2012 WL 3575293 (E.D. La. Aug. 20, 2012) ....................................................17 Johnson v. Sawyer, 47 F.3d 716 ................................................................................................................................5 Lemelle v. Stryker Orthopaedics, 698 F. Supp. 2d 668 (W.D. La. 2010) ........................................................................................4 Linsley v. C.R. Bard, Inc., 2000 WL 343358 (E.D. La. March 30, 2000) ..........................................................................16 Lovelace v. Software Spectrum Inc., 78 F.3d 1015, 1017-18 (5th Cir. 1996) ......................................................................................5 Malbroux v. Jancuska, 2011 WL 3816104 (W.D. La. Aug. 29, 2011) .......................................................................8, 9 McBride v. Medtronic, Inc., 2013 WL 3491085 (W.D. La. July 10, 2013) ........................................................................2, 7 McQuiston v. Boston Scientific Corp., 2009 WL 4016120 (W.D. La. November 19, 2009) ..................................................................9 Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 4 of 27 PageID #: 56 iv In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp. 2d 1147 (D. Minn. 2009), aff’d, 623 F. 3d 1200 (8th Cir. 2010) .......................10 Oppenheimer v. Prudential Securities, Inc., 94 F. 3d 189 (5th Cir. 1996) ......................................................................................................7 Pardo v. Medtronic, Inc., 2010 WL 5300847 (E.D. La. Dec. 15, 2010) ...........................................................................10 Poole v. Hologic, Inc., 2010 WL 3021528 (W.D. La. 2010) ....................................................................................9, 11 Poole v. Hologic, Inc., Slip .............................................................................................................................................9 Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ......................................................................................................... passim Rios v. City of Del Rio, 444 F. 3d 417 (5th Cir. 2006) ..................................................................................................14 Smith v. Medtronics, Inc., No. 13-451, 2014 WL 2547813 (W.D. La. June 7, 2014) .........................................................7 Sons v. Medtronic, 915 F. Supp. 2d 776 (W.D.La. 2013) ............................................................................... passim Swayze v. McNeil Laboratories, Inc., 807 F.2d 464 (5th Cir.1987) ....................................................................................................19 Tellabs, Inc. v. Makor Isues & Rights, Ltd., 551 U.S. 308 (2007) ...................................................................................................................7 Theriot v. Danek, 168 F. 3d 253 (5th Cir. 1999) ..................................................................................................16 Willett v. Baxter Intern., Inc., 929 F.2d 1094 (5th Cir. 1991) ...........................................................................................16, 17 Williard v. Humana Health Plan of Texas, 336 F.3d 375 (5th Cir. 2003) .....................................................................................................5 Zachary v. Dow Corning Corp., 884 F. Supp. 1061 (M.D. La. 1995) .........................................................................................17 Statutes 21 U.S.C. §360(e) c..........................................................................................................................4 Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 5 of 27 PageID #: 57 v Food, Drug and Cosmetics Act (FDCA) .......................................................................................1,4 La. C.C. Arts. 2315-2317, 2317.1, 2320, 2322, and 2324 .........................................................6, 18 La. R.S. 9:2800.52 .........................................................................................................................17 La. R.S. 9:2800.54 .........................................................................................................................17 La. R.S. 9:2800.57 .........................................................................................................................16 Louisiana Products Liability Act, La. R.S. 9:2800.51, et seq. .........................................................5 LPLA...................................................................................................................................... passim Other Authorities FDA, Medical Devices, PMA Application Contents http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoM arketYourDevice ........................................................................................................................4 FDA website at http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapp rovalsandclearances/pmaapprovals/default.htm ........................................................................5 Federal Rule of Civil Procedure 12(b)(6) ..................................................................................7, 13 Federal Rule of Evidence 201(b) .....................................................................................................7 Federal Rule of Evidence 201(b) and 201(c) ...................................................................................5 Federal Rules of Civil Procedure 8 and 12(b)(6) .............................................................................7 www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm ......................................................5 Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 6 of 27 PageID #: 58 I. INTRODUCTION This matter involves various claims brought against Globus Medical, Inc.1 (“Globus”) related to a Class III approved medical device designed and distributed by Globus to treat cervical spine disorders. The device at issue is the SECURE-C Artificial Cervical Disc (“SECURE-C”), which consists of a polyethylene Core and two cobalt Endplates. The essence of plaintiff’s claim is that an unknown design or manufacturing defect caused the Core of the device to extrude or migrate resulting in injury, a known potential complication of spinal implant surgery. The SECURE-C is an implantable medical device which was approved by the Food and Drug Administration (“FDA”) through the extensive Premarket Approval process. (“PMA” process) See Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008); Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 344 (2001) “Class III devices are subject to the greatest level of FDA scrutiny and ‘must complete a thorough review process with the FDA before they may be marketed.’” Sons v. Medtronic, 915 F. Supp. 2d 776, 780 (W.D.La. 2013)(quoting Buckman, supra. at 531 U.S. 341, 344, (2001)). Accordingly, every aspect of the SECURE-C device was scrutinized by the FDA during the PMA process, including its design, manufacturing process, warnings and labeling, with the FDA ultimately confirming that the device was “safe and effective.” Recognizing the extensive requirements imposed by the Food, Drug and Cosmetics Act (“FDCA”) and the 1976 Medical Device Amendments (“MDA”) of the FDCA for Class III devices, the United States Supreme Court in Riegel, held that any state court tort claim which 1Both Globus Medical, Inc. and Globus Medical North America, Inc. were named as Defendants. However, Globus Medical North America, Inc. was not involved in the design, manufacture or distribution of the device at issue. The motion is brought on behalf of both defendants. Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 7 of 27 PageID #: 59 2 sought to impose requirements “different from or in addition to” those imposed by the FDA PMA process would be barred. Riegel, 552 U.S. at 321-322. The Fifth Circuit and Louisiana federal courts have followed Riegel and granted numerous motions preempting claims involving PMA approved medical devices. See e.g. Gomez v. St. Jude Medical Daig Division, Inc., 442 F.3d 919 (5th Cir. 2006) (applying preemption to a device that received Premarket Approval); Sons, supra. (W.D. La. 2013)(granting preemption- based motion to dismiss); McBride v. Medtronic, Inc., 2013 WL 3491085 (W.D. La. July 10, 2013)(dismissing manufacturing defect and related claims as preempted). All of plaintiff’s claims here are based upon the allegation that the Globus device was defective in its design, manufacture, performance and warning. They challenge the safety and efficacy of a Class III medical device that was approved by the FDA pursuant to its comprehensive PMA process. Plaintiff’s claims for strict liability essentially would require this court or a jury to conclude that the device should have been designed, manufactured, labeled and sold in a way that was different from what was required by the FDA PMA. These claims are, therefore, preempted. In addition to being preempted by the MDA, Plaintiff fails to allege facts sufficient to support any claim against Globus under Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955 (2007). Third, Plaintiff’s negligence claims also fail because they are subsumed into the Louisiana Products liability Act (“LPLA”), which sets forth the exclusive theories of liability against manufacturers for damage allegedly caused by their products and they also fail to state a claim. For these reasons, all of Plaintiff’s claims are preempted and no amendment to the Complaint can cure its defects. Accordingly, Globus Motion to Dismiss should be granted and Plaintiff’s Complaint should be dismissed with prejudice. II. FACTUAL BACKGROUND A. The Globus SECURE-C and Plaintiff’s Surgery. Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 8 of 27 PageID #: 60 3 Plaintiff’s claims arise out of the implantation of the SECURE-C, which was designed and distributed by Globus. The SECURE-C is an intervertebral disc implant designed to replace a damaged cervical disc, providing motion similar to that of a natural cervical spine. The device itself is comprised of two cobalt-chrome endplates and a central polyethylene core. The device is an alternative treatment to fusion surgery, which involves removing the damaged disc and implanting plates and screws with an interbody graft or spacer to fuse the spinal segment and restrict motion. Plaintiff’s Complaint alleges that on or about July 8, 2015, Plaintiff underwent an anterior cervical discectomy at three levels of the spine from C5 to T1. Compl. at ¶5. Plates and screws with cadaveric bone graft manufactured by Medtronic were implanted at two of the levels of the spine from C5-6 and C6-C7 to achieve fusion. Id. at 5, 7. The SECURE-C artificial disc was inserted at one level of the spine at C7-T1. Id. Plaintiff alleges that on or about August 10, 2015, Plaintiff “began to experience new intermittent burning and shocking pain in his neck and right forearm pain and numbness.” Id. at ¶9. The Complaint further alleges that on or about August 11, 2015, a cervical MRI was performed which revealed that the SECURE-C “had failed to perform and/or function as designed causing the artificial disc to extrude and/or migrate from its original location in construction resulting in a right lateral disc extrusion/herniation at C7-T1 resulting in moderate to severe proximal right foraminal stenosis.” Id. at ¶10. Plaintiff allegedly underwent a successful revision surgery in August 2015 to remove the SECURE-C and a fusion of the C7-T1 level was performed with Medtronic plates, screws and bone graft, similar to the fusion done at the C5-C7 levels in July. Id. at ¶11. B. The FDA Premarket Approval Process Determines Safety and Efficacy and the FDA Continues To Monitor and Regulate PMA Devices. Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 9 of 27 PageID #: 61 4 Class III medical devices, such as the SECURE-C, are regulated by the FDA pursuant to the 1976 MDA to the FDCA. See 21 U.S.C. § 360c. Class III devices are “for a use in supporting or sustaining human life,” that are “of substantial importance in preventing impairment of human health,” or that present a potential unreasonable risk of illness or injury ...” Lemelle v. Stryker Orthopaedics, 698 F. Supp. 2d 668, 672 (W.D. La. 2010) (citing 21 U.S.C. § 360c(a)(1)(C)); see also Godfrey, 2011 WL 7768092, at *3. As part of the PMA process, “[t]he FDA spends an average of 1,200 hours reviewing each application and grants premarket approval only if it finds there is a reasonable assurance of the device’s safety and effectiveness.” Riegel v. Medtronic, Inc., 552 U.S. 312, 317-18 (2008) (internal citations and quotations omitted); 21 U.S.C. § 360e(c).2 If the FDA is not satisfied with the information provided by the applicant, it can request more information. See Riegel, 552 U.S. at 318 (citing 21 U.S.C. § 360e(c)(1)(G)). If the FDA decides a device’s design, manufacturing, development, testing, marketing, labeling or physician training should be revised, it can and will require revisions prior to Premarket Approval. See id. at 319 (citing 21 C.F.R. § 814.44(e)). “Once a device has received pre-market approval, the MDA 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.” Sons, 915 F. Supp. 2d at 780 (citing Riegel at 319). Further, “[i]f the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental pre-market approval, to be evaluated under largely the same criteria as an initial application.” Id. (citing Riegel at 319; citing 21 U.S.C. 360e(d)(6); 21 C.F.R. § 814.39(c)). C. The Globus SECURE-C Received FDA Premarket Approval. 2See FDA, Medical Devices, PMA Application Contents http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice / PremarketSubmissions/PremarketApprovalPMA/ucm050289.htm) (last visited July 12, 2016). Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 10 of 27 PageID #: 62 5 The Globus SECURE-C is a Class III medical device which received Premarket Approval from the FDA on September 28, 2012 under PMA Number P100003. See Exhibit A, Premarket Approval FDA Letter granting PMA Approval and Database Listing for SECURE-C CERVICAL ARTIFICIAL DISC, P100003.3 Prior to Plaintiff’s July 8, 2015 surgery, PMA Supplements were granted by the FDA on March 15, 2013, September 6, 2013, May 8, 2014, and December 18, 2014.4 See Exhibit B, Supplemental Premarket Approval Database Listings for P100003. Only the SECURE-C approved under the PMA process can be and are sold and marketed by Globus.5 D. Plaintiff’s Causes of Action Are Preempted. Plaintiff’s Complaint asserts products liability claims under the Louisiana Products Liability Act (“LPLA”), La. R.S. 9:2800.51, et seq., for design, manufacturing, marketing, 3“In assessing a motion to dismiss, a district court may take judicial notice of federal regulations and official acts of the federal government in implementing those regulations. See Williard v. Humana Health Plan of Texas, 336 F.3d 375, 379 (5th Cir. 2003) (“In deciding a motion to dismiss the court may consider ... matters of which judicial notice may be taken.”); Lovelace v. Software Spectrum Inc., 78 F.3d 1015, 1017-18 (5th Cir. 1996) (same); Johnson v. Sawyer, 47 F.3d 716, 733-34 (5th Cir. 1995 (judicial notice properly taken of federal regulations). Defendants request that this Court take Judicial Notice of the documents in Exhibit A and B pursuant to Federal Rule of Evidence 201(b) and 201(c). Exhibit A and B are official government records related to the PMA approval of the SECURE-C device and are available to the public at the FDA website at http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearance s/pmaapprovals/default.htm. In accordance with the President’s eRulemaking Initiative, the FDA’s Federal Docket Management System allows the public access to Federal Registers, Petitions, supporting documents and comments. Exhibit A-the SECURE-C device’s PMA approval, supplements, and listings-along with other materials related to SECURE-C’s PMA approval are available in the public domain from the FDA and on the FDA’s internet website at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm and entering PMA number P100003.” 4The Supplemental PMA approvals involved: approving a minor modification to the narrow implant holder (PMA Supplement 1); approving additional device-specific instrumentation associated with the SECURE-C disc (PMA Supplement 2); approving the post-approval study protocol)(PMA Supplement 3); and approving additional device sizes)(PMA Supplement 4). 5The SECURE-C Premarket Approval remains in place. The FDA has never revoked, withdrawn, or otherwise suspended the Premarket Approval for the SECURE-C. See Exhibit A, reflecting Globus’ current PMA database listing. Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 11 of 27 PageID #: 63 6 construction and warning defects and breach of express warranty (and redhibition). Compl. ¶¶ 18-55. Plaintiff also included claims of negligence under La. C.C. Arts. 2315-2317, 2317.1, 2320, 2322, and 2324. Compl. ¶¶ 56-58 (1)-(9). Plaintiff’s Complaint alleges seven (7) causes of action, the first five of which are made under the LPLA as follows: 1) Unreasonably dangerous characteristics, namely for the product to remain secure and intact once implanted. Compl. ¶¶18-19; 2) Unreasonably Dangerous In Construction or Composition because the Core failed to stay secure and/or in position between the endplates as designed due to “the construction and/or composition of the engagement feature on the inferior surface of the SECURE-C Core and/or because of the construction and/or composition of the SECURE-C Endplates,” or in the alternative, that the device deviated in a material way from the specifications or performance standards of Globus or from otherwise identical products manufactured by Globus.” Compl. ¶¶21-26; 3) Unreasonably Dangerous In Design because the “engagement feature on the Core is not present and/or fails to perform as designed and the Core can extrude from the endplates,” the device is susceptible to failure, and “failed to stay secure and/or in position between the endplates as designed,” alternatively, the “Endplates are ineffective… and allow the core to extrude and/or migrate” and finally that Globus “knew and, because of scientific and technological information available at the time, should have known that, as designed, the [device] was unreasonably dangerous and an alternative design was feasible.” Compl. ¶¶27- 36; 4) Inadequate Warnings, specifically Globus failed to warn “ordinary consumers” that the product could fail and that movement or minimal trauma could allow the Core to extrude or migrate. Compl.¶¶37-43; 5) Not Conforming To Express Warranty as allegedly described in marketing materials as a “motion-sparing technology designed as an alternative to fusion” whichis “guaranteed against faulty materials and workmanship, including engineering, composition, construction and design.” Compl.¶¶44-48; 6) Redhibition, claiming that the device was defective because it extruded/migrated, Plaintiff bought the medical device which is only available to surgeons by prescription and that Plaintiff was unaware of the defect. Compl. ¶51-55; and 7) Negligence for failure to instruct/educate their sales representatives and surgeons concerning the device “qualities, propensity, limitations and risks,” including the potential risk of Core extrusion/migration, and negligence in distributing a defective device and distributing a device that is unreasonably dangerous in construction, Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 12 of 27 PageID #: 64 7 composition, design, lacks adequate warning, and fails to conform to express warranty. Compl. ¶¶58. All of Plaintiff’s claims would require a jury to substitute its judgment for that of the FDA, allowing them to decide that the SECURE-C was not “safe or effective” but instead should have been designed, manufactured or labeled in a different way than that required by the FDA. These claims are preempted in their entirety by the FDA’s PMA approval. III. LEGAL ARGUMENT A. Legal Standard for Granting A Motion to Dismiss Under Federal Rule of Civil Procedure 12(b)(6). Dismissal under Federal Rules of Civil Procedure 8 and 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 .S. 662, 679 (2009); Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007). Although well- pleaded factual allegations are to be taken as true, Oppenheimer v. Prudential Securities, Inc., 94 F. 3d 189, 194 (5th Cir. 1996), the Court also can consider judicially-noticed facts at the motion to dismiss stage pursuant to Federal Rule of Evidence 201(b). Tellabs, Inc. v. Makor Isues & Rights, Ltd., 551 U.S. 308, 322 (2007); Funk v. Stryker Corp., 631 F.3d 777, 783 (5th Cir. 2011). Specifically, this District Court has taken judicial notice of FDA PMA Approvals and Database Entries such as those requested in the present matter: A court “may take judicial notice of and consider the public records of the FDA . . . without transforming a [motion to dismiss] into a motion for summary judgment.” Rollins v. St. Jude Medical, 583 F.Supp.2d 790, 805 (W.D. La. 2008) (citation omitted). Sons, 915 F. Supp. 2d at 781; see also Smith v. Medtronics, Inc., No. 13-451, 2014 WL 2547813 at *2 (W.D. La. June 7, 2014) (taking judicial notice of various FDA documents concerning the Class III device at issue).6 Plaintiff’s Complaint must be dismissed because the SECURE-C is an FDA PMA Class III device and therefore Plaintiff’s claims are preempted by the MDA. 6See also McBride v. Medtronic, Inc., 2013 WL 3491085 at *2 (W.D. La. July 10, 2013) (“[W]e hereby take judicial notice of the FDA information presented by [defendant] Medtronic verifying Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 13 of 27 PageID #: 65 8 In addition, a complaint must contain more than “labels and conclusions” or “a formulaic recitation of the elements of a cause of action.” Twombly, 550 U.S. at 555. In his Complaint, Plaintiff has failed to allege sufficient facts to state a plausible and viable claim for relief against Globus regarding the SECURE-C either under the LPLA or for negligence. B. Federal Preemption Bars Plaintiff’s Claims Against Globus. 1. Plaintiff’s Claims are Expressly Preempted by the MDA. Where a prescription medical device has received Premarket Approval, the MDA’s express preemption clause preempts state-law causes of action such as those raised by Plaintiff. As the United States Supreme Court confirmed in Riegel, Congress precluded plaintiffs from asserting state-law claims challenging the design, manufacturing process, or labeling of a medical device that has been approved by the FDA pursuant to the PMA process. Riegel, 552 U.S. at 325. Such claims necessarily would require a jury to second-guess the FDA’s determination that the device is “safe and effective” and could be marketed as approved. Id. (stating “[a] jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with [the medical device’s] benefits; the patients who reaped those benefits are not represented in court.” The scope of this preemption includes claims sounding in negligence, breach of warranty, and strict liability. See id. at 327. It also includes manufacturing defect claims. See id. at 321 (affirming trial court’s conclusion that “the MDA preempt[s] a negligent manufacturing claim insofar as it [i]s not premised on the theory that [the defendant] violated federal law”). that Synchromed II pump is a Class III PMA device.”); Malbroux v. Jancuska, 2011 WL 3816104 at *2, FN 23 (W.D. La. Aug. 29, 2011) (relating to the device at issue’s declaration of PDP completion, which is “equivalent to PMA approval, “[t]he Court is entitled to take judicial notice of [the FDA Declaration of PDP Completion] because it is reflected in the public records of the FDA.”). Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 14 of 27 PageID #: 66 9 Post-Riegel decisions by the Fifth Circuit, Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012), Hughes v. Boston Scientific Corp., 631 F. 3d 762 (5th Cir. 2011), and Funk v. Stryker Corp., 631 F. 3d 777 (5th Cir. 2011), likewise recognize that state tort claims are preempted to the extent they assert state tort liability despite compliance with FDA requirements. The MDA preemption clause establishes a two-step procedure for determining if state- law claims are preempted. First, a court must determine whether “the Federal Government has established requirements applicable to” the particular medical device. Riegel, 552 U.S. at 321. If it has, the court then must determine whether the state-law claims raised would impose “requirements with respect to the device that are ‘different from, or in addition to’” the federal requirements, and that relate to either (i) “safety or effectiveness” or (ii) “any other matter included in a requirement applicable to the device [under the MDA].” Id. at 321-23 (quoting U.S.C. § 360k(a)). If both of these conditions are satisfied, then the claim is preempted. This is precisely what Plaintiff is attempting to do - impose different requirements than that required by the FDA. Plaintiff has set forth state law claims which would impose requirements different than those approved through the PMA process. Such claims are preempted. Aside from the Supreme Court’s ruling in Riegel, Louisiana federal courts and courts around the country have applied this preemption clause and dismissed similar claims at the pleadings stage. See, e.g., Sons, 915 F. Supp. at 781 (granting preemption-based motion to dismiss); Malbroux v. Jancuska, 2011 WL 3816104 (W.D. La. Aug. 29, 2011) (granting preemption-based motion to dismiss); Couvillier v. Allergan Inc., 2011 U.S. Dist. LEXIS 12919 (W.D. La. Feb 9, 2011) (adopting magistrate’s recommendation and granting preemption-based motion to dismiss); Poole v. Hologic, Inc., Slip Copy, 2010 WL 3021528, at *6 (W.D. La. July 29, 2010) (granting preemption-based motion for judgment on the pleadings); McQuiston v. Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 15 of 27 PageID #: 67 10 Boston Scientific Corp., 2009 WL 4016120, at *7 (W.D. La. November 19, 2009) (same); Cenac v. Hubbell, 2010 WL 4174573 (E.D. La. Oct 21, 2010) (same); Pardo v. Medtronic, Inc., 2010 WL 5300847, at *4 (E.D. La. Dec. 15, 2010) (granting preemption-based motion for summary judgment converted from motion to dismiss); Bencomo v. Guidant Corp., 2009 WL 1951821, at *6 (E.D. La. June 30, 2009) (granting preemption-based motion to dismiss).7 Even before Riegel, the Fifth Circuit held that state law causes of action are generally preempted by the Premarket Approval process. See Gomez v. St. Jude Medical Daig Division, Inc., 442 F. 3d 919, 929 (5th Cir. 2006) (state product-liability claims arising from a Class III medical device were preempted because those claims relate to areas specifically covered in the PMA process and sought to impose requirements that were “different from and, indeed, conflict with” the results of the PMA process). Based on this analysis, Plaintiff’s claims are plainly preempted and barred by the MDA. Plaintiff is alleging state law claims, all of which, if successful, would impose a different duty on Defendants than was required under the PMA process. Plaintiff claims that the SECURE-C device possessed “dangerous characteristics,” and was “unreasonably dangerous in construction or composition,” “unreasonably dangerous in design,” contained “inadequate warnings” and breached an express warranty would require a jury to find that the SECURE-C device should have been different in some way and/or were not safe and effective despite Premarket Approval and the requirements imposed by FDA as part of such approval. In addition, Plaintiff simply claims that the “product deviated in a material way” from unidentified Globus “specifications or 7See also Cohen v. Guidant Corp., 2011 WL 637472, at *2 (C.D. Cal. Feb. 15, 2011) (granting a motion to dismiss and holding that state law claims relating to a pacemaker with Premarket Approval were preempted); Covert v. Stryker Corp., 2009 WL 2424559, at *13 (M.D.N.C. Aug. 5, 2009) (dismissing all claims against manufacturer of medical device which received Premarket Approval); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp. 2d 1147 (D. Minn. 2009), aff’d, 623 F. 3d 1200 (8th Cir. 2010) (granting a motion to dismiss as to a federal MDL involving the Premarket Approved medical device). Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 16 of 27 PageID #: 68 11 performance standards.” These claims cannot avoid preemption. See Godfrey v. Advanced Neuromodulation Systems, Inc., 211 WL 7768092, *8 (5th Cir. 2011) (Court concluded that claims of liability premised on deviations from the manufacturer’s own specifications or performance standards do not avoid preemption under Riegel.) If Plaintiffs were to prove that the SECURE-C was defective due to design, construction or composition or in their warnings, they would essentially be challenging the design or manufacturing process that the FDA specifically approved for the device. The same is true for Plaintiff’s inadequate warning and breach of express warranty claims. Plaintiff alleges that Globus failed to adequately warn consumers that the product could fail and presented an unreasonably dangerous risk beyond what the ordinary consumer would reasonably expect. Plaintiff does not allege that Globus changed or failed to include FDA approved warnings. Instead, they allege that under the LPLA additional and different warnings should have been given. The FDA PMA approval includes specific language for Class III device labels and warnings. Plaintiff’s claim therefore seeks to impose a state requirement that is “different from or in addition to” the federal requirement and is therefore preempted. As pled, Plaintiff’s claims demand a jury to conclude that the FDA’s assessment of safety and effectiveness with respect to the SECURE-C, including its design, manufacture, testing, development, marketing, labeling, promotion, sale and distribution was incorrect. Asking them to make such a determination is barred. See Riegel, 552 U.S. at 325 (extending preemption over state tort actions that prescribe a design that is deemed “safer” but differs from the federally approved requirement); Poole, 2010 WL 3021528, at *3-4 (negligent design and manufacture, strict liability, warranty, and negligence claims preempted). Such claims necessarily conflict with the FDA’s determination that PMA approved medical devices are reasonably safe and effective and seek to impose state law requirements that are different from or in addition to the Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 17 of 27 PageID #: 69 12 requirements imposed by the FDA. It is clear Plaintiff seeks to bring claims despite Globus’ compliance with FDA requirements, and such claims should therefore be dismissed. 2. Plaintiff’s LPLA State Law Claims are Preempted. Plaintiff cites to the LPLA, but such claims have been recognized as expressly preempted by the MDA. See, e.g., Hinkel v. St. Jude Medical, S.C., 869 F. Supp. 2d 739, 746 (E.D. La. 2012) (citing Gomez, 442 F. 3d at 930-932, and recognizing that “LPLA claims amount[ ] to a ‘state law challenge’ to the federally countenanced requirements” and thus LPLA claims are “completely preempted”); Cenac, 2010 WL 4174573, at *7 (the LPLA “creates [ ] state requirement[s] that [are] ‘different from or in addition to’ the federal requirements” and are thus preempted). The generic string of five claims set forth in Plaintiff’s Complaint under the LPLA are preempted. Such claims under the LPLA would undermine the FDA’s PMA determination that the SECURE-C is reasonably safe and effective when used in accordance with its approved labeling. They seek to impose additional or different state law requirements on the manufacturer. Riegel, 128 S. Ct. at 1007-1008; See Godfrey v. Advanced Neuromodulation Systems, Inc, 2011 WL 7768092 *8 (5th Cir. 2011)(court concluded that an express warranty claim under the LPLA requires proof that the warranty was untrue and imposes a requirement that was potentially inconsistent with the federal scheme and it is therefore preempted.). “To permit a jury to second-guess the Angio-Seal design by applying the Louisiana statutory standard for unreasonably dangerous design would risk interference with the federally- approved design standards and criteria.” Gomez, 442 F.3d at 930; see also Riegel, 128 S. Ct. at 1008 (“to exclude common-law duties from the scope of pre-emption would make little sense.”); Godfrey, 2011 WL 7768092 at *9 (‘federal law preempts plaintiff’s challenge to the design of the Class III FDA-approved” device and its claim that an alternative safe design existed because the “FDA studied and approved the design through the PMA process.”); Hinkel v. St. Jude Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 18 of 27 PageID #: 70 13 Medical, S.C., 869 F. Supp. 2d 739, 748 (E.D. La. 2012), citing Poole v. Hologic, Inc., 2010 WL 3021528 at *5 (W.D. La. 2010)(Permitting plaintiff to prove that an alternative design existed and that the choice not to adopt that design was unreasonable “would allow the state to directly contradict the FDA’s determination that the approved design… was both “safe and effective.”) Accordingly, this Court should find that Plaintiff’s product liability claims under the LPLA are preempted by the MDA and Plaintiff’s complaint should be dismissed in its entirety. C. Plaintiff’s Claims Are Preempted By The MDA But The Complaint Also Fails to Allege Facts Sufficient to Support Any Claim Against Globus. Notwithstanding the preemption of Plaintiff’s claims, alternatively, dismissal under Federal Rule of Civil Procedure 12(b)(6) is appropriate because Plaintiff’s Complaint fails to state a claim for relief “that is plausible on its face.” Iqbal, 129 S. Ct. at 1949; Twombly, 550 U.S. at 570; see also Cuvillier, 503 F.3d at 401. To the extent that the Court determines that Plaintiff’s claims are preempted, it is not necessary to address the plausibility of Plaintiff’s claims under Twombly. “[P]laintiff’s obligation to provide the ‘grounds’ for the entitle[ment] to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do...” Twombly, 127 S.Ct. at 1964-65. Factual allegations must be enough to raise a right to relief above the speculative level. Id. at 1965 (citations omitted). On a motion to dismiss, courts are not bound to accept as true legal conclusions couched as factual allegations, like those in Plaintiff’s Complaint. Id. (citing Papasan v. Allain, 478 U.S. 265, 286 (1986)). Courts also need not permit plaintiffs who demand discovery in the hope they will be able to cure their pleading deficiencies: “Gone are the days when a plaintiff could assert ‘a wholly conclusory statement of claim and survive a motion to dismiss simply because his pleadings left open the possibility that [he] might later establish some set of undisclosed facts to support recovery.’” Callaway v. Am. Med. Sys., Inc., CIV.A. 11-00193, 2011 WL 7724268, at * Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 19 of 27 PageID #: 71 14 4 (W.D. La. Dec. 8, 2011) report and recommendation adopted, CIV.A.11-00193, 2012 WL 1354573 (W.D. La. Jan. 24, 2012) (citing Twombly). Here, Plaintiff’s Complaint makes conclusory allegations and fails to plead sufficient facts under Iqbal and Twombly. Plaintiff’s Complaint fails to “give [Defendant] fair notice of what the … claim is and the grounds upon which it rests.” Twombly, 550 U.S. at 555. (internal quotations and citation omitted). Plaintiff fails to allege any facts that come close to properly pleading a claim of a product defect. As explained by the Fifth Circuit, a statement of facts: [T]hat merely creates a suspicion that the pleader might have a right of action is insufficient. Dismissal is proper if the complaint lacks an allegation regarding a required element necessary to obtain relief...The court is not required to conjure up unpled allegations or construe elaborately arcane scripts to save a complaint. Further, conclusory allegations or legal conclusions masquerading as factual conclusions will not suffice to prevent a motion to dismiss. Rios v. City of Del Rio, 444 F. 3d 417, 421 (5th Cir. 2006) (citations omitted). The first five counts of Plaintiff’s Complaint simply mimics language from the LPLA but is devoid of any factual allegations, other than conclusory statements, supporting Plaintiff’s product defect claims against Globus. Specifically, although Plaintiff avers that the SECURE-C is “unreasonably dangerous in design,” Plaintiff does not allege how the device’s design was dangerous, much less “unreasonably” dangerous, but simply claims that the SECURE-C is defective for one of two reasons. Either the Core “is not secure and susceptible to extrude from the SECURE-C Endplates” because the “engagement feature … is not present and/or fails to perform;” or the SECURE-C Endplates “are ineffective.” Id. at ¶30. Plaintiff does not identify how or why the Endplates are “ineffective” and does not explain how or why the Core is not secure and susceptible to extrusion/migration. Plaintiff’s Complaint not only fails to give Globus any notice of the grounds upon which Plaintiff’s design defect claim rests, but also requires the Court to conjure up un-pled allegations Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 20 of 27 PageID #: 72 15 and make assumptions in order to save Plaintiff’s Complaint. Such language is expressly insufficient for a statement of facts under Twombly and Iqbal. Moreover, Plaintiff is required under LSA-R.S. 9:2800.56 to identify an alternative design that was capable of preventing the damage caused to him. Although Plaintiff’s Complaint alleges that an alternative design exists, it fails to identify what that alternative design is or how that alternative design would have prevented the alleged damage or injury. Id. at ¶¶34-36. Similarly, to the extent that Plaintiff claims that the device at issue was defective in manufacture, Plaintiff simply alleges that the Core failed “because of the construction and/or composition of the engagement feature on the inferior surface of the Core and/or construction and/or composition of the Endplates.” Compl. ¶26. Plaintiff does not identify in what way the “construction and/or composition” of either the Core or the Endplates was defective. While Plaintiff alleges that the device deviated from the “specification or performance standards” of Globus, again Plaintiff fails to identify the “specifications or standards” they are referring to, in what way those so called “specifications or standards” were violated or how such a violation caused any alleged damage or injury. Indeed, Plaintiff’s Complaint is as vague as the one in Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011), where the Fifth Circuit Court of Appeals dismissed plaintiff’s complaint because it “provid[ed] no facts” and was “impermissibly conclusory and vague” where “it [did] not specify the manufacturing defect; nor [did] it specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury.” The same is true here and therefore the Complaint must be dismissed. To the extent that Plaintiff alleges that the SECURE-C did not conform to an express warranty, Plaintiff cites to language allegedly found in SECURE-C’s marketing materials. Id. at Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 21 of 27 PageID #: 73 16 ¶¶ 46-47. Plaintiff does not allege that this language was contrary to that approved by the FDA as part of the PMA process, in what way the device failed to live up to the alleged marketing language or how that failure caused any harm or injury. For example, Plaintiff references the statement that the “SECURE-C is designed to allow up to +15˚ motion in flexion-extension and up to +10˚ motion in lateral bending.” Id. at ¶46. However, Plaintiff did not allege whether the SECURE-C at issue failed to allow such motion or any other specifications or that any alleged failure to do so caused the injury complained of. As to Plaintiff’s allegations of inadequate warnings, Plaintiff simply claims that there was no warning to “ordinary consumers” that the product could fail, that it “possessed characteristics that could cause damage” and that “every day movement and/or minimal trauma” could cause extrusion and/or migration of the SECURE-C Core. For the most part, these allegations are a mere restatement of the statutory language found in La. R.S. 9:2800.57. Id. at ¶¶ 38-39, 42-43. In addition, Plaintiff improperly pled that Globus owed a duty to warn consumers, without acknowledging that under Louisiana’s Learned Intermediary Doctrine, the duty to warn runs only to the surgeon, not the patient. Theriot v. Danek, 168 F. 3d 253, 256 (5th Cir. 1999) (finding that [b]ecause this case involves a medical product, the learned intermediary doctrine applie[d]” and that under the Learned Intermediary Doctrine, the manufacturer had an obligation to inform the plaintiff’s doctor.); Willett v. Baxter Intern., Inc., 929 F.2d 1094, 1098 (5th Cir. 1991) (“With regard to prescription drugs and medical products such as these heart valves, Louisiana follows the Learned Intermediary Doctrine. Under this doctrine, the manufacturer has no duty to warn the patient, but need only warn the patient’s physician.”). Ivory v. Pfizer, 2009 WL 3230611 (W.D. La. Sept. 30, 2009); Guidry v. Aventis Pharmaceuticals, Inc., 418 F.Supp.2d 835 (M.D. La. 2006); Bencomo v. Guidant Corp., 2008 WL 3364960 at *2 (E.D. La. Aug. 8, 2008); Linsley v. C.R. Bard, Inc., 2000 WL 343358 at *5 (E.D. La. March 30, 2000) (finding that Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 22 of 27 PageID #: 74 17 the product at issue “was and is a prescription medical device, which requires that it be used only upon order of a qualified physician, thus the warning required is not to the general public or to the patient, but to the prescribing physician.”); Harris v. Danek Med., Inc., 1999 U.S. Dist. LEXIS 18893 at *11 (M.D. La. July 21, 1999); Zachary v. Dow Corning Corp., 884 F. Supp. 1061, 1065 (M.D. La. 1995). The test therefore is not whether an “ordinary user or consumer” has been adequately warned but instead the plaintiff must allege and prove that the manufacturer failed to warn or inadequately warned the physician of a risk associated with the product that was not otherwise known to the physician, and that the failure to warn was both a cause in fact and the proximate cause of the plaintiff’s injury. Willett, 929 F.2d. at 1099-98. Here, Plaintiff makes no attempt to establish that the warning was inadequate to a qualified surgeon or a causal connection whatsoever between the alleged inadequate warning and any claimed injury. D. Plaintiff’s Negligence Claims Of a Failure to Instruct/Educate Are Preempted By The MDA, But Also Fail Due to the Exclusivity of the LPLA and Their Failure to State a Claim. The LPLA provides the exclusive theories of liability for manufacturers for damage caused by their products and sets forth four theories under which a plaintiff may recover. La. R.S. 9:2800.52; see also Jacobsen v. Wyeth, LLC, No. 10-0823, 2012 WL 3575293, at *5 (E.D. La. Aug. 20, 2012). Under the LPLA, a plaintiff may recover against a manufacturer if the plaintiff can establish that the product is unreasonably dangerous due to: (1) a defect in construction or composition; (2) a design defect; (3) a failure to provide an adequate warning; or (4) a failure to comply with an express warranty. La. R.S. 9:2800.54; Jacobsen, 2012 WL 3575293, at*5. Thus, a claimant may not recover from a manufacturer for damage caused by a product on the basis of any theory of liability not set forth in the LPLA. Butler v. La. State Univ. Health Sci. Ctr., No. 12-CV-1838, 2012 WL 3263888, at *2 (W.D. La. Aug. 9, 2012). Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 23 of 27 PageID #: 75 18 Here, Plaintiff attempts to assert negligence theories of recovery that fall outside the LPLA. Specifically, Plaintiff has alleged claims for negligence under La. C.C. Arts. 2315-2317, 2317.1, 2320, 2322, and 2324 for failure to instruct/educate and/or inform their sales representatives, physicians and hospitals about the SECURE-C’s “qualities propensity, limitations and risks” including the alleged risk ‘that every day movement and/or minimal trauma could allow” it to extrude or migrate. Compl. ¶¶56-58 (1)-(9). All of these claims fail under Louisiana law due to the exclusivity of the LPLA. Aside from the exclusivity of the LPLA, these claims fail because they are preempted by the MDA and also fail to state a claim for which relief can be granted. See Sons v. Medtronic, 915 F. Supp.2d 776 (W.D. La. 2013). In Sons, the Louisiana District court concluded that plaintiff’s failure to train/instruct claims were not only preempted by the MDA but separate and apart they failed to state a claim for which relief could be granted. Like our case, Sons involved a PMA approved device and Plaintiff alleged that the device manufacturer (Medtronic) ‘‘fail[ed] to properly train, supervise, and/or equip the doctors and/or surgical techs responsible for emplacement of their product,’’ and fail[ed] to provide a representative of Medtronic to educate the physician implanting the Medtronic pacemaker.’’ Id. at 783. The Sons court concluded that any failure to train or instruct was preempted based upon Riegel explaining that: “In Riegel, the Supreme Court held that any attempt to impose a requirement relating to the safety or effectiveness of the device that is different from, or in addition to, federal requirements is preempted.” Sons at 783, citing Riegel at 327-28, 128 S. Ct. 999 and citing in support, Gomez v. St. Jude Med. Daig Div., Inc., 442 F.3d 919, 926 (5th Cir.2006) (failure to train medical personnel claim was preempted as a matter of law). The District Court in Sons went a step further, concluding that aside from the claim being preempted, it did not state a claim upon which relief could be granted: Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 24 of 27 PageID #: 76 19 “Nevertheless, even assuming arguendo that plaintiff’s failure to train/instruct claims are not preempted, plaintiff has failed to state a claim for which relief can be granted. It is well established that a medical device manufacturer is not responsible for the practice of medicine. In Swayze v. McNeil Laboratories, Inc., 807 F.2d 464, 468 (5th Cir.1987), the Fifth Circuit refused to impose on a manufacturer a ‘‘duty to intrude into the hospital operation as well as the doctor-patient relationship.’’ In affirming the trial court’s grant of directed verdict in favor of a drug manufacturer on plaintiff’s negligence claims, the court stated, ‘‘[i]t is both impractical and unrealistic to expect drug manufacturers to police individual operating rooms to determine which doctors adequately supervise their surgical teams;’’ see also Hall v. Horn Medical, LLC, 2012 WL 1752546, at *3 (E.D.La.2012) (finding it ‘‘patently unreasonable’’ for a ‘‘seasoned neurosurgeon to rely on a sales representative’s opinion about the type of procedure that should be employed in operating on a patient’s spine.’’) Id. at 783. Plaintiff’s negligence claims should therefore be dismissed for three separate and independent reasons: they fail because of the exclusivity of the LPLA, they are preempted under the MDA and they fail to state a claim upon which relief can be granted. IV. CONCLUSION All of Plaintiff’s claims against Defendants are expressly preempted by the MDA’s express preemption clause and in accordance with the United States Supreme Court’s decision in Riegel as well as the decisions in the Fifth Circuit and District Courts of Louisiana. Further, independent state law grounds bar Plaintiff’s claims and their request for damages. Defendants respectfully request that this Motion to Dismiss be granted and Plaintiff’s claims be dismissed with prejudice. Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 25 of 27 PageID #: 77 20 Respectfully submitted: BY: /s/ Andrew L. Plauché, Jr. ANDREW L. PLAUCHÉ, JR (# 11023) ELIZABETH B. CARVILLE (#27949) Plauché Maselli Parkerson LLP 701 Poydras Street, Suite 3800 New Orleans, Louisiana 70139 Telephone: 504-582-1142 Fax: 504-582-1172 Email: aplauche@pmpllp.com E-mail:acarville@pmpllp.com Denise B. Bense (Admitted Pro Hac Vice) Cozen O’Connor One Liberty Place 1650 Market Street Philadelphia, PA 19103 Telephone: 610-832-8351 Fax: 877-836-0584 E-mail:dbense@cozen.com COUNSEL FOR GLOBUS MEDICAL, INC. and GLOBUS MEDICAL NORTH AMERICA, INC. Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 26 of 27 PageID #: 78 CERTIFICATE OF SERVICE I hereby certify that on this 19th day of August, 2016, I served the foregoing pleading on all parties by using the CM/ECF system, which automatically sends email notifications of such filing to all counsel of record. s/ Andrew L. Plauché, Jr. Case 6:16-cv-00872-DDD-CBW Document 10-1 Filed 08/19/16 Page 27 of 27 PageID #: 79 EXHIBIT “A” Case 6:16-cv-00872-DDD-CBW Document 10-2 Filed 08/19/16 Page 1 of 7 PageID #: 80 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service. Food andi Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002 Globus Medical, Inc %Kelly J Baker, PhD Vice President. -Regulatory and Clinical Affairs 2560 General Armistead Avenue SEP 28 2012 Audibon, Pennsylvania 19403 Re: PI00003 Secure-C Artificial Cervical Disc Filed: September 17,2010 Amended: November 10, 2010; July 19, July 28, August 30, October 26, Decembei 19, 2011; January 4, June90, July 24, August 23, 2012. Procode:. MJO DearDr. Baker: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completedits.review of your premarket approval application (PMA) for the Secure-C Artificial Cervical Disc. Thisdevice is indicated inskeletally mature patients for reconstruction of the dise at one level from C3-C7 following single-level discectomy ffor intractable radiculopathy (arm pain and/or a neurological deficitw.with or without neck pain, or myelopathy due to a single- level abnormality localized to the disc space and at least one of the following conditions confirmed herniated nucleus pulposus, spondylosis (defined byby radiographic imaging'(CT, MRI, X-rays): the presence of osteophytes), and/or visible loss of disc.height as compared to adjacent levels. The SECURE@ C Cervical Artificial Disct.iimplantedusing an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the SECUR e-C Cervical Artificial Disc. We are pleased to inIfort you that the PMA is approved You may begin commercial distribution of the device in accordance with the conditions of approval described below. The sale, and distribution ofthis device are restricted to prescription usein accordance with 21 CFR 801.109 andtinder section 515(d)(I)(B)(ii) of the Federal.Food, Drug, and Cosmetic Act (the act). The device:isLfirther restricted under sectionS 15(d)(1)(B)(ii).of the act insofar asthe labeling must specify the specific training:or experience practitioners need it order to use the device. FDA has determnined that these restrictions on sale:and distribution are necessary to provideteasonible assuratice of the safety and effectivenessof the device. Your devic&is thefore a restricted device subject:to the requirements inisections 502(q) and (r) of the act, in addition to the many other FDA inarketing of dvices:.requirementsgpyermigthe manufacture, distribution, an- Expiration dating for this device has beeh established and approved at five years. This is to advise that the protocol you usedito establish this expirationdating is considered an approved yo protbcol forthe purpose of extending the expirationfdating:as provided by,21 CFR 84.39(a)(7). ,,. .1 Case 6:16-cv-00872-DDD-CBW Document 10-2 Filed 08/19/16 Page 2 of 7 PageID #: 81 Page 2 - Kelly J. Baker, PhD Continued approval of this PMA is contingent upon the submission of periodic reports, required under 21 CFR 814.84, at intervals of one year (unless otherwise specified) from the date of approval of the original PMA. Two copies of this report, identified as "Annual Report" (please use this title even ifthe specified interval is more frequent than one year) and bearing the applicable PMA reference number, should be submitted to the address below. The Annual Report should indicate the beginning and ending date of the period covered by the report and should include the information required by 21 CFR 814.84. In addition to the above, and in order to provide continued reasonable assurance of the safety and effectiveness of the device, the Annual Report must include, separately for each model number (if applicable), the number of devices sold and distributed during the reporting period, including those distributed to distributors. The distribution data will serve as a denominator and provide necessary context for FDA to ascertain the frequency and prevalence of adverse events, as FDA evaluates the continued safety and effectiveness ofthe device. You have agreed to provide the following data as part of the annual report: You must attempt to retrieve all explanted SECURE-C devices (including but not limited to those retrieved from patients in the PAS and ESS) for analysis. All retrievals will be analyzed and reported per the agreed Explant Analysis protocol. In addition to the Annual Report requirements, you must provide the following data in post- approval study reports (PAS). I. ExtendedFollow-upofPremarketCohort: You must perform a 7-year post-approval study (PAS) to evaluate the longer term safety and effectiveness of the SECURE-C Cervical Artificial Disc as compared to ACDF by following the 334 subjects from the pivotal investigational device exemption (IDE) study (220 SECURE-C subjects, and 114 ACDF subjects) annually through 7 years. At each annual (+4 month) visit, you will collect the following data: Neck Disability Index, neck and right/left arm pain Visual Analog Scale (VAS), health status survey (SF-36), patient satisfaction, neurological status, radiographic information, medication usage and postoperative treatment for pain management, work status, and all adverse events regardless of cause. Radiographic information collected will include: range ofmotion on flexionlextension films (angulation and translation as well as the correlation of range ofmotion with outcomes), disc height, radiolucency, device displacement or migration, spinal fusion (control arm only), and heterotopic ossification (including grade, stability over time, and correlation with patient characteristics and postoperative outcomes). You will also collect data on adjacent level degeneration/disease including both surgical and non-surgical adjacent level treatments as well as adjacent level diagnoses and adjacent level range of motion. Case 6:16-cv-00872-DDD-CBW Document 10-2 Filed 08/19/16 Page 3 of 7 PageID #: 82 Page 3 - Kelly J. Baker, PhD The primary objective of the study is to evaluate the overall success rate, using Overall Success Definition 1,defined as: * Pain/Disability Improvement of at least 25% in the Neck Disability Index (NDI) at 5 years and 7 years compared with the score at baseline; * No device failures (at the index level) requiring revision, re-operation, removal or supplemental fixation; * Absence ofmajor complications defined as major vessel injury, neurological damage, or nerve injury- and * For control fusion patients only, radiographic fusion, as defined by the presence of bridging trabecular bone, without evidence of pseudarthrosis. You also have agreed to conduct an additional analysis evaluating Overall Success Definition 2, defined as follows: * Pain/Disability Improvement of at least 15 points in the Neck Disability Index (NDI) at 5 years and 7 years compared with the score at baseline; * No secondary surgery at the index level, including revision, removal, reoperation and supplemental fixation; * No potentially device-related adverse events; * Maintenance or improvement in all components of neurologic status; * No SECURE-C intraoperative changes in treatment; Success rates between the randomized investigational and control groups will be compared and assessed for non-inferiority based on a ten percent non-inferiority margin for both overall success analyses. Patients who were non-recoverable non-responders prior to 24 months will carry forward as failures for each subsequent annual visit. Several sensitivity analyses will also be done. FDA will expect at least 85% follow-up at the 7-year time point to provide sufficient data to evaluate safety and effectiveness. 2. EnhancedSurveillance System: You must perform a 10-year Enhanced Surveillance Study (ESS) ofthe SECURE-C Cervical Artificial Disc to fully characterize adverse events when the device is used in the intended patient population under general conditions of use in the United States and in the rest of the world. You will collect, analyze, and submit all adverse event data including subsequent surgeries, beterotopic ossification, and other device issues. Information will be actively collected from annual surgeon surveys and on the company 3 Case 6:16-cv-00872-DDD-CBW Document 10-2 Filed 08/19/16 Page 4 of 7 PageID #: 83 Page 4 - Kelly J. Baker, PhD website. Information will also be collected passively through complaints and MDRs, explant analysis, and literature review. In addition, you will actively collect surgeon feedback annually to elicit information related to heterotopic ossification, device malfunction, device removal, or other serious device-related complications. This information will be collected using surgeon surveys. All of the surgeons who have been trained on the use of SECURE®-C in the U.S. will be surveyed annually and the number of surveys issued and received will be reported. If a survey response includes any information related to an adverse event, you will collect additional data as specifically outlined in the ESS protocol and report that data to FDA. Please be advised that the results from these studies should be included in the labeling as these data become available. Any updated labeling must be submitted to FDA in the form ofa PMA Supplement. Within 30 days of your receipt of this letter, you must submit PMA supplements that include complete protocol for each ofyour post-approval studies. Your PMA supplements should be clearly labeled as a "Post-Approval Study Protocol" and submitted in triplicate to the address below. Please reference the PMA number above to facilitate processing. FDA would like to remind you that you are required to submit separate PAS Progress Reports for each of the Post-approval studies listed above, every six months during early stages of the study implementation up to two years and annually thereafter. The reports should clearly be identified as Post-Approval Study Report. Two copies for each study, identified as "PMA Post- Aporoval Study Report" and bearing the applicable PMA reference number, should be submitted to the address below. For more information on post-approval studies, see the FDA guidance document entitled, "Procedures for Handling Post-Approval Studies Imposed by PMA Order" 7097 4 h(www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDochmentsluemO Be advised that the failure to conduct any such study in compliance with the good clinical laboratory practices in 21 CFR part 58 (ifa non-clinical study subject to part 58) or the institutional review board regulations in 21 CFR part 56 and the informed consent regulations in 21 CFR part 50 (ifa clinical study involving human subjects) may be grounds for FDA withdrawal ofapproval of the PMA. Before making any change affecting the safety or effectiveness of the device, you must submit a PMA supplement or an alternate submission (30-day notice) in accordance with 21 CFR 814.39. All PMA supplements and alternate submissions (30-day notice) must comply with the applicable requirements in 21 CFR 814.39. For more information, please refer to the FDA guidance - The PMAdocument entitled, "Modifications to Devices Subject to Premarket Approval (PMA) Supplement Decision-Making Process" (www.fda.gov/MedicalDevices/DeviceRepulationandGuidace/Guidanc-eDocumentslucm089274.h to) Case 6:16-cv-00872-DDD-CBW Document 10-2 Filed 08/19/16 Page 5 of 7 PageID #: 84 Page 5 - Kelly J.Baker, PhD You are reminded that many FDA requirements govern the manufacture, distribution, and marketing of devices. For example, in accordance with the Medical Device Reporting (MDR) regulation, 21 CFR 803.50 and 21 CFR 803.52, you are required to report adverse events for this device. Manufacturers of medical devices, including in vitro diagnostic devices, are required to report to FDA no later than 30 calendar days after the day they receive or otherwise becomes aware of information, from any source, that reasonably suggests that one of their marketed devices: 1. May have caused or contributed to a death or serious injury- or 2. Has malfunctioned and such device or similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Additional information on MDR, including how, when, and where to report, is available at www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. In accordance with the recall requirements specified in 21 CFR 806.10, you are required to submit a written report to FDA of any correction or removal of this device initiated by you to: (1)reduce a risk to health posed by the device; or (2) remedy a violation of the act caused by the device which may present a risk to health, with certain exceptions specified in 21 CFR 806. 10(a)(2). Additional information on recalls is available at www.fda.gov/Safety/Recalls/IndustrvGuidance/default.htm. CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. CDRH will notify the public of its decision to approve your PMA by making available, among other information, a summary of the safety and effectiveness data upon which the approval is based. The information can be found on the FDA CDRH Internet HomePage located at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceAprovalsandClearances/P MAApprovals/default.htm. Written requests for this information can also be made to the Food and Drug Administration, Dockets Management Branch, (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The written request should include the PMA number or docket number. Within 30 days from the date that this information is placed on the Internet, any interested person may seek review of this decision by submitting a petition for review under section 515(g) of the act and requesting either a hearing or review by an independent advisory committee. FDA may, for good cause, extend this 30-day filing period. Failure to comply with any post-approval requirement constitutes a ground for withdrawal of approval of a PMA. The introduction or delivery for introduction into interstate commerce of a device that is not in compliance with its conditions of approval is a violation of law. You are reminded that, as soon as possible and before commercial distribution ofyour device, you must submit an amendment to this PMA submission with copies of all approved labeling in final printed form. Final printed labeling that is identical to the labeling approved in draft form will not routinely be reviewed by FDA staff when accompanied by a cover letter stating that the final printed labeling is identical to the labeling approved in draft form. If the final printed labeling is 5 Case 6:16-cv-00872-DDD-CBW Document 10-2 Filed 08/19/16 Page 6 of 7 PageID #: 85 Page 6 - Kelly J.Baker, PhD not identical, any changes from the final draft labeling should be highlighted and explained in the amendment All required documents should be submitted in triplicate, unless otherwise specified, to the address below and should reference the above PMA number to facilitate processing. One ofthose three copies may be an electronic copy (eCopy), in an electronic format that FDA can process, review and archive (general information: http://wwwfda.gnov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/Pre marketSubmissions/ucml34508.htm, clinical and statistical data: http://www.fda.gov/MedicalDevices/DeviceRegulat-ionandGuidance/HowtoMarketYourDevice/Pre marketSubmissions/ucm 136377.htrn) U.S. Food and Drug Administration Center for Devices and Radiological Health PMA Document Mail Center - W066-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Ifyou have any questions concerning this approval order, please contact Sarah Leismer at 301-796- 5650. Sincerely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health 6 Case 6:16-cv-00872-DDD-CBW Document 10-2 Filed 08/19/16 Page 7 of 7 PageID #: 86 EXHIBIT “B” Case 6:16-cv-00872-DDD-CBW Document 10-3 Filed 08/19/16 Page 1 of 7 PageID #: 87 Case 6:16-cv-00872-DDD-CBW Document 10-3 Filed 08/19/16 Page 2 of 7 PageID #: 88 Case 6:16-cv-00872-DDD-CBW Document 10-3 Filed 08/19/16 Page 3 of 7 PageID #: 89 Case 6:16-cv-00872-DDD-CBW Document 10-3 Filed 08/19/16 Page 4 of 7 PageID #: 90 Case 6:16-cv-00872-DDD-CBW Document 10-3 Filed 08/19/16 Page 5 of 7 PageID #: 91 Case 6:16-cv-00872-DDD-CBW Document 10-3 Filed 08/19/16 Page 6 of 7 PageID #: 92 Case 6:16-cv-00872-DDD-CBW Document 10-3 Filed 08/19/16 Page 7 of 7 PageID #: 93 Case 6:16-cv-00872-DDD-CBW Document 10-4 Filed 08/19/16 Page 1 of 1 PageID #: 94