Breaux v. Globus Medical Inc

MOTION to Dismiss For Failure to State a Claim

W.D. La.October 16, 2017

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 FIRST SUPPLEMENTAL AND AMENDED COMPLAINT FOR DAMAGES 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 First Supplemental and Amended Complaint filed by Plaintiff Paul Breaux. Despite receiving pre-complaint discovery and inspecting the subject device, Plaintiff’s First Supplemental and Amended Complaint nevertheless fails on the following grounds: 1. Plaintiff’s Amended 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, 550 U.S. 544 (2007); and 3. Plaintiff’s redhibition and negligence claims are preempted, fail due to the exclusivity of the Louisiana Products Liability Act, and also fail to state a claim. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 1 of 43 PageID #: 730 2 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. 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 53 Filed 10/16/17 Page 2 of 43 PageID #: 731 CERTIFICATE OF SERVICE I hereby certify that on this day, 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. Dated: October 13, 2017 s/ Andrew L. Plauché, Jr. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 3 of 43 PageID #: 732 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 PLAINTIFF’S FIRST SUPPLEMENTAL AND AMENDED COMPLAINT FOR DAMAGES 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 53 Filed 10/16/17 Page 4 of 43 PageID #: 733 i TABLE OF CONTENTS Page I. INTRODUCTION .............................................................................................................. 1 II. PROCEDURAL BACKGROUND ..................................................................................... 4 III. FACTUAL BACKGROUND ............................................................................................. 4 A. The Globus SECURE-C and Plaintiff’s Surgery. ................................................... 4 B. The FDA Mandated Investigation of the Plaintiff’s Device Concluded That The Core Was Manufactured Within Product Specifications, and Was Maintained and Distributed in Accordance With All Federal, State and Operating Procedures. ...................................................................................... 5 C. The FDA Premarket Approval Process Determines Safety and Efficacy and the FDA Continues To Monitor and Regulate PMA Devices.......................... 8 D. The Globus SECURE-C Received FDA Premarket Approval. .............................. 9 E. Plaintiff’s Causes of Action Must Be Dismissed. ................................................. 10 IV. LEGAL ARGUMENT ...................................................................................................... 11 A. Legal Standard for Granting A Motion to Dismiss Under Federal Rule of Civil Procedure 12(b)(6). .................................................................................. 11 1. The Court Can Take Judicial Notice That the SECURE-C is an FDA PMA Class III Device and Plaintiff’s Claims are Preempted by the MDA. ........................................................................... 12 2. The Court Can Consider Documents Referenced But Not Attached to The Plaintiff’s Complaint, and Appended to Globus’ Motion to Dismiss. ...................................................................... 13 B. Plaintiff’s Claims are Expressly Preempted by the MDA. ................................... 14 C. Plaintiff’s Express Warranty Claim Is Preempted by the MDA And Plaintiff’s Amended Complaint Also Fails to Allege Facts Sufficient to Support That Claim. ......................................................................... 16 D. Plaintiff’s Redhibition, and Negligence Claims Are Preempted By The MDA, But Also Fail Due to the Exclusivity of the LPLA and Plaintiff’s Failure to State a Claim. ....................................................................... 18 E. Plaintiff’s Manufacturing Defect Claim is Preempted by the MDA But Plaintiff Also Fails to Allege Sufficient Facts To Support That Claim. ........ 21 1. Plaintiff Fails To Identify A Defect Which Existed At The Time of Manufacture And Simply Describes The Core’s Condition After Explant. ........................................................................... 21 2. The Very Documents Plaintiff Relies Upon Conclude That The Subject Device Was Manufactured Within The FDA Approved Product Specifications. ............................................................ 23 Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 5 of 43 PageID #: 734 ii F. Plaintiff’s Amended Complaint Does Not State a Manufacturing Defect Claim That Survives Preemption. ............................................................. 24 1. GMP Violations Cannot Serve As The Basis For A Parallel State Claim. ........................................................................................................ 24 2. Plaintiff Does Not Dispute That Globus Has Established and Maintained Procedures In Compliance With The Federally Prescribed GMPs. ..................................................................................... 25 3. Plaintiff Has Not Met The Pleading Threshold Necessary To Allege A Violation of a Federal Regulation. ............................................ 29 V. CONCLUSION ................................................................................................................. 30 Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 6 of 43 PageID #: 735 iii TABLE OF AUTHORITIES Page(s) Cases Ashcroft v. Iqbal, 556 U.S. 662 (2009) ...........................................................................................................11, 21 Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) ........................................................................................... passim Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) ......................................................................................................... passim Bencomo v. Guidant Corp., 2009 WL 1951821 (E.D. La. June 30, 2009) ...........................................................................15 Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) ...................................................................................................................1 Burkett v. Smith & Nephew GmbH, 2014 WL 1315315 (E.D.N.Y. 2014) ........................................................................................24 Butler v. La. State Univ. Health Sci. Ctr., No. 12-CV-1838, 2012 WL 3263888 (W.D. La. Aug. 9, 2012) ..............................................18 Caboni v. Gen. Motors Corp., 278 F.3d 448, 452 (5th Cir. 2002) ...........................................................................................17 Cenac v. Hubbell, 2010 WL 4174573 (E.D. La. Oct 21, 2010) ..........................................................15, 16, 24, 25 Cohen v. Guidant Corp., 2011 WL 637472 (C.D. Cal. Feb. 15, 2011)............................................................................15 Couvillier v. Allergan Inc., 2011 WL 8879259 (W.D. La. Feb 9, 2011) .............................................................................15 Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009) ..........................................................................15 Cuvillier, 503 F.3d at 401 ..............................................................................................................21 Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011) .......................................................................................12, 14, 26 Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 7 of 43 PageID #: 736 iv Gavin v. Medtronic, Inc., 2013 WL 3791612 (E.D. La. Jul. 19, 2013) ................................................................16, 19, 26 Godfrey v. Advanced Neuromodulation Systems, Inc, 2011 WL 7768092 (W.D. La. Apr. 4, 2011)........................................................................8, 28 Gomez v. St. Jude Medical Daig Division, Inc., 442 F.3d 919 (5th Cir. 2006) ...................................................................................2, 16, 18, 20 Hall v. Horn Medical, LLC, 2012 WL 1752546 (E.D.La.2012) ...........................................................................................20 Hernandez v. Stryker Corp., 2014 WL 7044171 (W.D. Wash. 2014) ...................................................................................24 Hinkel v. St. Jude Medical, S.C., 869 F. Supp. 2d 739 (E.D. La. 2012) .......................................................................................16 Horn v. Boston Scientific, 2011 WL 3893812 (S.D. Ga. 2011) .........................................................................................24 Horowitz v. Stryker Corp., 613 F.Supp.2d 271 (E.D.N.Y. 2009) .......................................................................................25 Hughes v. Boston Scientific Corp., 631 F. 3d 762 (5th Cir. 2011) ..................................................................................................14 Ilarraza v. Medtronic, Inc., 677 F.Supp. 2d 582 (E.D.N.Y. 2009) ......................................................................................24 Izadjoo v. Helix Energy Sols. Grp., Inc., 237 F. Supp. 3d 492, 502 .........................................................................................................13 Jacobsen v. Wyeth, LLC, No. 10-0823, 2012 WL 3575293 (E.D. La. Aug. 20, 2012) ....................................................18 James v. Diva Int’l, Inc., 803 F. Supp. 2d 945 (S.D. Ind. 2011) ......................................................................................24 Jefferson v. Lead Indus. Ass’n, Inc., 930 F.Supp. 241 (E.D.La.1996) aff’d, 106 F.3d 1245 (5th Cir. 1997) ....................................18 Johnson v. Sawyer, 47 F.3d 716 (5th Cir. 1995) .......................................................................................................9 Lemelle v. Stryker Orthopaedics, 698 F. Supp. 2d 668 (W.D. La. 2010) ........................................................................................8 Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 8 of 43 PageID #: 737 v Lovelace v. Software Spectrum Inc., 78 F.3d 1015, 1017-18 (5th Cir. 1996) ......................................................................................9 Malbroux v. Jancuska, 2011 WL 3816104 (W.D. La. Aug. 29, 2011) ...................................................................12, 14 McBride v. Medtronic, Inc., 2013 WL 3491085 (W.D. La. July 10, 2013) ..........................................................2, 12, 25, 26 McQuiston v. Boston Scientific Corp., 2009 WL 4016120 (W.D. La. November 19, 2009) ..........................................................15, 29 In re Medtronic, 623 F.3d at 1207 ......................................................................................................................30 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) ...........15, 25, 28 Meyers v. Textron, Inc., 540 F. App’x 408 (5th Cir. 2013) ............................................................................................12 Oppenheimer v. Prudential Securities, Inc., 94 F. 3d 189 (5th Cir. 1996) ....................................................................................................12 Pardo v. Medtronic, Inc., 2010 WL 5300847 (E.D. La. Dec. 15, 2010) ...........................................................................15 Parra v. Coloplast Corp., 2017 WL 24794 (E.D.La. Jan. 3, 2017) .............................................................................17, 25 Pearsall v. Medtronics, Inc., 2015 WL 8160888 (E.D.N.Y. 2015) ........................................................................................24 Poole v. Hologic, Inc., 2010 WL 3021528 (W.D. La. July 29, 2010) ....................................................................15, 16 Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ......................................................................................................... passim Rios v. City of Del Rio, 444 F. 3d 417 (5th Cir. 2006) ..................................................................................................21 Rollins v. St. Jude Medical, 583 F.Supp.2d 790 (W.D. La. 2008) ..................................................................................12, 30 Scianneaux v. St. Jude Medical S.C., Inc., 961 F.Supp.2d 808 (E.D.La. 2013) ....................................................................................19, 26 Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 9 of 43 PageID #: 738 vi Skinner v. St. Jude Medical, Inc., 2016 WL 4054931 (W.D. La. July 27, 2016) ..........................................................................26 Smith v. Medtronics, Inc., No. 13-451, 2014 WL 2547813 (W.D. La. June 7, 2014) .......................................................12 Sons v. Medtronic, Inc., 915 F. Supp. 2d 776 (W.D. La. 2013) .............................................................................. passim Swayze v. McNeil Laboratories, Inc., 807 F.2d 464 (5th Cir.1987) ....................................................................................................20 Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308 (2007) .................................................................................................................12 Williams v. E.I. du Pont de Nemours & Co., 154 F. Supp. 3d 407, 411 (M.D. La. 2015) ........................................................................11, 13 Williamston v. Medtronic, Inc., 2014 WL 2042004 (W.D. La. May 15, 2014) ...................................................................26, 29 Williard v. Humana Health Plan of Texas, 336 F.3d 375 (5th Cir. 2003) .....................................................................................................9 Statutes 21 U.S.C. §360c ...............................................................................................................................8 21 U.S.C. § 360e(c)..........................................................................................................................8 21 U.S.C. § 360i(a) ..........................................................................................................................6 Food, Drug and Cosmetics Act ....................................................................................................1, 8 La. C.C. Arts. 2315-2317, 2317.1, 2320, 2322, and 2324 ................................................. 10, 18-19 La.C.C. Art. 2520, et seq. ........................................................................................................10, 18 La. R.S. 9:2800.52 .........................................................................................................................18 La. R.S. 9:2800.54 .........................................................................................................................18 Louisiana Products Liability Act, La. R.S. 9:2800.51, et seq. ............................................... passim Other Authorities 21 C.F.R. §20.63 ..............................................................................................................................7 21 C.F.R. §803.10(c)........................................................................................................................6 Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 10 of 43 PageID #: 739 vii 21 C.F.R. § 803.11 ...........................................................................................................................6 21 C.F.R. § 820.72 .........................................................................................................8, 24, 27, 28 21 C.F.R. § 820.90 ...................................................................................................................10, 27 5C Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 1357 (3d ed.) ............................................................................................................................13 FDA, Medical Devices, PMA Application Contents http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoM arketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm05028 9.htm ..........................................................................................................................................8 Federal Rules of Civil Procedure 8 ................................................................................................11 Federal Rule of Civil Procedure 12 .........................................................................................11, 14 Federal Rule of Civil Procedure 56 ...............................................................................................11 Federal Rule of Evidence 201(b) ...................................................................................................12 Federal Rule of Evidence 201(c) .....................................................................................................9 Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 11 of 43 PageID #: 740 I. INTRODUCTION Plaintiff Paul Breaux requested and received pre-complaint discovery. Despite the fact that Plaintiff was provided almost 600 pages of documents which included the SECURE-C FDA approved product specifications records and drawings, the complete manufacturing records for the subject device as well as Globus’ standard operating procedures approved by the FDA for the manufacture of the subject device and the Summary of Safety and Effectiveness Date (SSED) submitted to the FDA as part of the FDA PMA approval, and given the opportunity to inspect the subject medical device in March 2017, Plaintiff’s First Supplemental and Amended Complaint (“Amended Complaint”) has not cured the defects present in his initial complaint and it must therefore be dismissed. This matter involves various claims brought against Globus Medical, Inc. (“Globus”) related to a Class III approved medical device designed and distributed by Globus to treat cervical spine disorders.1 The device at issue is the SECURE-C Artificial Cervical Disc (“SECURE-C”), which consists of a polyethylene core (“Core”) and two cobalt endplates. The essence of Plaintiff’s claims is that the Core was defectively manufactured causing it to extrude or migrate resulting in injury, a known potential complication of spinal implant surgery. The SECURE-C is a Class III, 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, Inc., 915 F. Supp. 2d 776, 780 (W.D. La. 2013)(quoting Buckman, 531 U.S. 341, 344 (2001)). Accordingly, every aspect of the SECURE-C device was 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 53 Filed 10/16/17 Page 12 of 43 PageID #: 741 2 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 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). To the extent Plaintiff challenges the safety and efficacy of a Class III medical device that was approved by the FDA pursuant to its comprehensive PMA process, and not premised on a violation of federal law, all such claims are 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, 550 U.S. 544 (2007). Plaintiff’s manufacturing defect claim is preempted but also fails to allege facts sufficient to support a claim. Plaintiff’s claim rests on the allegation that the Core of the subject device was defective at the time of manufacture or distribution. In support of that claim and in an apparent attempt to mislead the Court, Plaintiff quotes from, but fails to attach, an FDA MAUDE Report and/or a Globus Engineering Evaluation Report that were prepared after the subject Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 13 of 43 PageID #: 742 3 device was explanted from the Plaintiff’s spine some 30 days after implant. Those Reports describe the condition of the subject device at the time of explant, not at the time of manufacture or distribution. Importantly, Plaintiff does not include the conclusions from those Reports which find that the subject device, including the Core, was manufactured to FDA approved product specifications. Accordingly, Plaintiff fails to set forth a plausible parallel state law claim of manufacturing defect and that claim must be dismissed. Plaintiff attempts to allege a parallel state law claim that Globus violated the FDA’s Good Manufacturing Practices (“GMPs”). However, the federal regulations that Plaintiff cites are too vague and general to properly state a claim that Globus violated federal regulations in the manufacture of the subject device. Further, Plaintiff does not dispute that Globus in fact had established procedures in place which complied with the GMPs and that its manufacturing records confirm that those procedures were followed. Finally, Plaintiff fails to properly state how the subject device failed to conform to its FDA approved product specifications. This is despite the fact that Globus has produced the FDA approved design, manufacturing and product specifications, drawings and standard operating procedures as well as the manufacturing records of the subject device. Plaintiff’s express warranty, redhibition and negligence claims are preempted and Plaintiff’s Amended Complaint also fails to allege facts sufficient to support those claims. Moreover, the redhibition and 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. For these reasons, all of Plaintiff’s claims should be dismissed and no further amendment to the Amended Complaint should be allowed to cure its defects. Accordingly, Globus’ Motion Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 14 of 43 PageID #: 743 4 to Dismiss should be granted and Plaintiff’s Amended Complaint should be dismissed with prejudice. II. PROCEDURAL BACKGROUND Plaintiff filed his initial Complaint on June 22, 2016. Dkt. #1. Globus filed its Motion to Dismiss on August 19, 2016. Dkt. #10. Plaintiff filed his Opposition to the Motion to Dismiss on November 3, 2016 (Dkt. #19) and Globus filed its Reply on November 28, 2016 (Dkt. # 22). By Order, dated January 28, 2017, the Magistrate Judge granted Plaintiff’s request to conduct discovery and to file an amended complaint, denying Globus’ motion to dismiss without prejudice to re-urge the same if indicated after Plaintiff filed an amended complaint. Dkt. #26. In response to the Court’s Order, Plaintiff submitted extensive discovery requests, which included Interrogatories, Requests for Production, and Requests for Admission. Globus responded to those requests on April 7, 2017 and produced almost 600 pages of documents by agreement on April 28, 2017. Those documents included the SECURE-C FDA approved product specifications records and drawings, the complete manufacturing records for the subject device as well as Globus’ standard operating procedures approved by the FDA for the manufacture of the subject device and the Summary of Safety and Effectiveness Date (SSED) submitted to the FDA as part of the FDA PMA approval. In addition, the subject device was provided to the Plaintiff and his expert for inspection for over two months, from March 7, 2017 through May 25, 2017. III. FACTUAL BACKGROUND A. The Globus SECURE-C and Plaintiff’s Surgery. 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 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. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 15 of 43 PageID #: 744 5 Plaintiff’s Amended 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. Amended Complaint (“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 ¶8. The Amended 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 ¶9. 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. The subject device was returned to Globus after it was explanted. Id. at ¶40. B. The FDA Mandated Investigation of the Plaintiff’s Device Concluded That The Core Was Manufactured Within Product Specifications, and Was Maintained and Distributed in Accordance With All Federal, State and Operating Procedures. Plaintiff now claims that the Core “deviated in a material way from Globus specifications or performance standards or from otherwise identical products manufactured by Globus.” Compl. ¶¶20, 25, 26. Plaintiff alleges that the Core was supposed to “have a uniform spherical curvature of the superior bearing surface.” Compl. ¶27. Plaintiff’s Amended Complaint claims that “at the time of manufacture” and when the device “left the control of Globus,” “the core was deformed and its deformation included loss of the uniform spherical curvature of the superior Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 16 of 43 PageID #: 745 6 bearing surface, circular deformations within the bearing surface and deformations in the lower regions of the recess features.” Compl. ¶¶10, 19, 27. Plaintiff claims that this alleged deformation “allowed the polymer core to escape posteriorly from the endplates.” Id. at ¶28. Plaintiff does not identify or attach the documents from which the above description of the alleged Core deformation was taken. Nor does the Plaintiff advise this Court that those same documents concluded that the Core was “manufactured within specifications and was maintained and distributed in accordance with all federal, state and operating procedures.” See Exhibit A (FDA MAUDE Report) and Exhibit B (Globus Engineer Evaluation)(an unopposed motion to file this Confidential document under seal has been filed with the Court). As noted above, the subject device was returned to Globus after it was explanted. An FDA mandated evaluation and investigation of the subject device was conducted by Globus and reported to the FDA.2 The FDA MAUDE database includes the results of the Globus investigation of the subject device in a FDA MAUDE Report (“FDA Report”) which is attached hereto as Exhibit A and was attached as Exhibit 3 to Globus’ Reply to Plaintiff’s opposition to Globus’ initial motion to dismiss. Dkt. #22-2. That report specifically concludes that the Core was “manufactured within specifications, maintained and distributed in accordance with all federal, state and operating procedures.” Id. The full description of Globus’ narrative of the event in the FDA Report, which describes the condition of the subject device after explant, reads in full as follows: Manufacturer Narrative 2 A manufacturer is required to report death or injuries to the FDA when such information becomes known to them, whether by a mandatory or voluntary reporter. See 21 U.S.C. § 360i(a), 21 C.F.R. §803.10(c). Any mandatory report required by Section 360i(a) is called a medical device report or MDR and is made on FDA Form 3500A. See 21 C.F.R. § 803.11. The FDA maintains a Manufacturer and User Facility Device Experience (“MAUDE”) database on its website. The MAUDE database houses adverse event reports (“MAUDE Reports”) that contain redacted summaries by the FDA of reported incidents, including excerpts from manufacturer MDRs, as well as reports submitted by mandatory and voluntary reporters. The MAUDE Reports are publicly available. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 17 of 43 PageID #: 746 7 A comprehensive investigation was immediately initiated on receipt of the complaint. The product was returned for evaluation. A review was conducted of all applicable material records, manufacturing records, storage records, and distribution records according to the descriptions of the product used with the concomitant device. All records revealed all product lots were manufactured within specifications, maintained and distributed in accordance with all federal, state and operating procedures. Upon evaluation neither endplate elicit major damages, fractures, or signs of failure. The bearing surfaces of the superior and inferior endplates were clean with a polished appearance, and no damaged features. Bony deposits were observed on the bony apposition side of the superior endplate. Scratches were observed on the non- bearing flange of both endplates consistent with surgical removal. The lateral view of the core showed loss of curvature of the superior bearing surface, biased towards the anterior aspect of the core. The superior aspect of the core showed mild circular deformation marks, as well as on the anterior inferior aspect of the core’s bearing surface. Based on the current information available, it is not possible to determine the cause of the posterior expulsion of the secure c core. Event Description It was reported to Globus that a patient had a revision surgery due to the secure c core having expulsed posteriorly. The initial surgery was performed (b)(6) 2015. The removal surgery was (b)(6) 2015.3 FDA MAUDE Report at Exhibit A (italics and emphasis added). Plaintiff’s Amended Complaint quotes just the italicized portions of the manufacturer narrative, failing to include in its complaint of the ultimate conclusion (bolded) that the subject device, including the Core, was manufactured within the product specifications and was maintained and distributed in accordance with all federal, state and operating procedures. In addition, Plaintiff was provided with and his Amended Complaint quotes portions of Globus’ Engineering Evaluation Report (“Globus’ Evaluation”), which describes the condition of the Core after it was explanted, not its condition at the time of manufacture: Polymer Core: Microscopic analysis was used to evaluate the returned part (Figure 9). The lateral view of the core showed loss of the uniform spherical curvature of the superior bearing surface, biased towards the anterior aspect of the core (Figure 10). Evaluation of the superior aspect of the SECURE-C core showed mild circular deformation marks (Figure 11). Furthermore, a total of 2 of these circular deformation features were observed; one found within the bearing surface and one was found on the 3 We note that in accordance with FDA regulations all patient identifying information is redacted from the FDA MAUDE Reports. See 21 C.F.R. §20.63. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 18 of 43 PageID #: 747 8 on the anterior non-bearing flange. Mild deformation marks were observed on the anterior inferior aspect of the core's bearing surface (Figure 12). The inferior recess features were observed to have undergone mild deformation (Figure 13). Oblique images show mild deformation in the lower regions of recess features (Figure 14). A bite mark was observed on the anterior aspect of the core consistent with use of a kocher or rongeur to extract the core (Figure 15). Evaluation Report at Exhibit B (emphasis added) (compare to Amended Complaint at ¶27.) Plaintiff fails to advise the Court that the Globus’ Evaluation specifically concluded that the Core, as well as the rest of the subject device, was manufactured within specifications as follows: Summary: The explanted Secure- C end plate assembly with Core were received on 8/25/2015 (Figure 1). A review of the Device History Record and further dimensional analysis per the product inspection sheet concluded that the implant returned was manufactured per specifications. Id. (emphasis added). Finally, Plaintiff does not dispute that Globus had procedures in place in compliance with the Quality System Regulations and Current Good Manufacturing Practices adopted by the FDA at 21 C.F.R. §820.72 and §820.90. Instead, Plaintiff claims that Globus violated federal regulations by failing to identify an alleged manufacturing defect in the Core of the subject device and by placing the device in the stream of commerce. Compl. ¶30. C. The FDA Premarket Approval Process Determines Safety and Efficacy and the FDA Continues To Monitor and Regulate PMA Devices. 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 v. Advanced Neuromodulation Systems, Inc, 2011 WL 7768092, *3 (W.D. La. Apr. 4, 2011). Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 19 of 43 PageID #: 748 9 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, 552 U.S. at 317-18 (internal citations and quotations omitted); 21 U.S.C. § 360e(c).4 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, 552 U.S. 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, 552 U.S. at 319; citing 21 U.S.C. 360e(d)(6); 21 C.F.R. § 814.39(c)). D. The Globus SECURE-C Received FDA Premarket Approval. The Globus SECURE-C received Premarket Approval from the FDA on September 28, 2012 under PMA Number P100003. See Exhibit C, Premarket Approval FDA Letter granting PMA Approval and Database Listing for SECURE-C CERVICAL ARTIFICIAL DISC, P100003.5 Prior to Plaintiff’s July 8, 2015 surgery, the FDA granted PMA Supplements on 4See FDA, Medical Devices, PMA Application Contents http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissio ns/PremarketApprovalPMA/ucm050289.htm) (last visited August 28, 2017). 5 “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, C and D pursuant to Federal Rule of Evidence 201(b) and 201(c). Exhibit A and B are official government records related to Adverse Event Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 20 of 43 PageID #: 749 10 March 15, 2013, September 6, 2013, May 8, 2014, and December 18, 2014.6 See Exhibit D, 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.7 E. Plaintiff’s Causes of Action Must Be Dismissed. Plaintiff’s Amended Complaint asserts products liability claims under the Louisiana Products Liability Act (“LPLA”), La. R.S. 9:2800.51, et seq., for manufacturing defect. Compl. ¶¶ 18-30. Plaintiff also asserts a claim for breach of express warranty, redhibition pursuant to La.C.C. Art. 2520, et seq., and claims of negligence under La. C.C. Arts. 2315-2317, 2317.1, 2320, 2322, and 2324. Compl. ¶¶ 31-34, 35-41, and 42-44. Plaintiff’s Amended Complaint alleges causes of action as follows: 1) Unreasonably Dangerous In Construction or Composition under the LPLA because the core “deviated in a material way from GLOBUS specifications and/or performance standards for the subject product” in that “the core was deformed and its deformation included loss of the uniform spherical curvature of the superior bearing surface, circular deformations within the bearing surface and deformations in the lower regions of the recess features.” This alleged “deformation in the superior bearing surface as well as deformation of the inferior recess features of the polymer core of the subject device allowed the polymer core to escape posteriorly from the endplates.” Plaintiff alleges that Globus failed to comply with the Quality System Regulations and Current Good Manufacturing Practices (CGMP) adopted by the FDA at 21 U.S.C. § 820.72 and § 820.90. Compl. ¶¶18-30. 2) Not Conforming To Express Warranty because “the polymer core was faulty in workmanship, composition and construction” despite the subject device being Reporting and the PMA approval of the SECURE-C device and are available to the public at the FDA websites at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM and http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/pmaapprovals/de fault.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 C - 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. 6 The 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). 7The 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 C, reflecting Globus’ current PMA database listing. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 21 of 43 PageID #: 750 11 “guaranteed against faulty materials and workmanship, including engineering, composition, construction and design.” Plaintiff further alleges Globus violated its express warranty by stating in marketing materials that “[w]e are driven to provide the highest quality products to improve the techniques and outcomes of spine surgery so patients can resume their lives as quickly as possible.” Compl.¶¶31-34. 3) Redhibition, claiming that the device was defective because the core was deformed at the time it left Globus’ control in such a manner that it expulsed, extruded, and/or migrated, Plaintiff bought the medical device which is only available to surgeons by prescription, and that Plaintiff was unaware of the defect. Compl. ¶¶35-41. 4) 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 and composition. Compl. ¶¶42-44. To the extent premised on violations of state law, 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. To the extent based on violation of federal regulations, Plaintiff’s manufacturing defect claim is preempted. In addition, none of the claims meet the Twombly pleading standard. Finally, Plaintiff’s claims under state law are subsumed by the LPLA. IV. 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 U.S. 662, 679 (2009); Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007). 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, for redhibition, or for negligence. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 22 of 43 PageID #: 751 12 Generally, when a court considers a motion to dismiss under Rule 12(b)(6), if “matters outside the pleadings are presented to and not excluded by the court, the motion must be treated as one for summary judgment under Rule 56.” Fed. R. Civ. P. 12(d). However, “there are some exceptions to this ostensibly ironclad standard.” Williams v. E.I. du Pont de Nemours & Co., 154 F. Supp. 3d 407, 411 (M.D. La. 2015). Specifically, when ruling on a motion to dismiss, a district court “may take into account documents incorporated into the complaint by reference or integral to the claim, items subject to judicial notice, matters of public record, orders, items appearing in the record of the case, and exhibits attached to the complaint whose authenticity is unquestioned.” Meyers v. Textron, Inc., 540 F. App’x 408, 409 (5th Cir. 2013) (citing Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322 (2007))(emphasis added). 1. The Court Can Take Judicial Notice That the SECURE-C is an FDA PMA Class III Device and Plaintiff’s Claims are Preempted by the MDA. 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 Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 23 of 43 PageID #: 752 13 Class III device at issue).8 Here, Plaintiff’s Amended 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. 2. The Court Can Consider Documents Referenced But Not Attached to The Plaintiff’s Complaint, and Appended to Globus’ Motion to Dismiss. It is well established in the Fifth Circuit that a court may consider documents attached to a defendant’s motion to dismiss “if they are referred to by the complaint and are integral and central to the plaintiff's claim(s).” Marrero v. Willbros Gp., Inc., No. 4:13-cv-0243, 2013 WL 5440595, at *3 (S.D. Tex. Sept. 25, 2013) (considering severance plan attached to defendants’ motion to dismiss and citing Collins v. Morgan Stanley Dean Witter, 224 F.3d 496, 498-99 (5th Cir. 2000)); accord Oliver v. Disa Glob. Sols., Inc., No. 2:16-cv-01582, 2017 WL 460783, at *2- 3 (W.D. La. Feb. 2, 2017) (considering positive drug test result and membership application form attached to defendants’ motion to dismiss because the documents were referred to in plaintiff’s petition and were “an integral part of this lawsuit.”); Izadjoo v. Helix Energy Sols. Grp., Inc., 237 F. Supp. 3d 492, 502 n.1 (S.D. Tex. 2017) (considering defendant’s earnings call presentation slides that were expressly relied on in plaintiff’s complaint and appended to motion to dismiss); Williams v. E.I. du Pont de Nemours & Co., 154 F. Supp. 3d 407, 412 (considering plaintiff’s EEOC charge, right to sue letters, EEOC amendment, “and several other related documents” that were referenced but not attached to the complaint, and appended to defendant’s motion to dismiss); see also 5C Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 1357 (3d ed.) (explaining that courts are “not limited to the four corners of the 8See 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 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 53 Filed 10/16/17 Page 24 of 43 PageID #: 753 14 complaint” when resolving a motion to dismiss, and generally “have allowed consideration of matters incorporated by reference or integral to the claim” without converting the motion to dismiss into a motion for summary judgment). Here, the sole support for Plaintiff’s manufacturing defect claim and corresponding claim of a federal regulation violation are portions quoted by Plaintiff from Globus’ Evaluation Report and/or the FDA’s MAUDE Report, a public record. These documents are referenced without citation and are integral to Plaintiff’s claim of manufacturing defect and violation of federal regulations. As a result, the Court may consider them in deciding this motion to dismiss under Rule 12(b)(6) without converting it into a motion for summary judgment. B. 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. As the 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. 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. 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. 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 (in granting Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 25 of 43 PageID #: 754 15 preemption-based motion to dismiss, dismissing plaintiff’s defective design, defective manufacture, failure to warn, negligence and failure to train medical personnel claims, court concluded that plaintiff’s allegations in essence challenged the FDA’s findings concerning the safety of the device and sought to impose requirements different from or in addition to federal regulations not only in the design and manufacture but in the warnings given); Malbroux v. Jancuska, 2011 WL 3816104 (W.D. La. Aug. 29, 2011) (in granting preemption-based motion to dismiss, court concluded that plaintiff’s allegations that the device was not reasonably safe and effective as designed, manufactured and labeled was contrary to the FDA’s approval and such claims were preempted)); Couvillier v. Allergan Inc., 2011 WL 8879259 (W.D. La. Feb 9, 2011) (adopting magistrate’s recommendation and granting preemption-based motion to dismiss plaintiff’s state law products liability claims).9 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 321.10 If it has, the court then must determine whether the state-law claims raised would impose 9See also Poole v. Hologic, Inc., 2010 WL 3021528, at *6 (W.D. La. July 29, 2010) (granting preemption-based motion for judgment on the pleadings, dismissing plaintiff’s design defect, manufacturing defect, inadequate warning and breach of warranty claims absent allegations that the specific device used during plaintiff’s surgery failed to conform to FDA approved specifications or standards.); McQuiston v. Boston Scientific Corp., 2009 WL 4016120, at *7 (W.D. La. November 19, 2009) (dismissing plaintiff’s state law claims against stent manufacturer for design defect, manufacturing defect, failure to warn, breach of warranty , negligence and fraud and inadequate testing as preempted by the MDA); 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, dismissing all of plaintiff’s claims);); Bencomo v. Guidant Corp., 2009 WL 1951821, at *6 (E.D. La. June 30, 2009) (granting preemption-based motion for summary judgment concluding that plaintiff's express warranty claim was preempted)); 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). 10 Plaintiff admits that the SECURE-C is a Class III device subject to approval by the FDA through the PMA process. Compl. ¶ 30. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 26 of 43 PageID #: 755 16 “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. Plaintiff’s Amended Complaint has set forth state law claims which would impose requirements different than those approved through the PMA process. Such claims are preempted. C. Plaintiff’s Express Warranty Claim Is Preempted by the MDA And Plaintiff’s Amended Complaint Also Fails to Allege Facts Sufficient to Support That Claim. Regarding Plaintiff’s breach of express warranty claim, Plaintiff would be required to persuade the fact finder that the SECURE-C was not safe and effective, a finding that would be contrary to the FDA’s approval. In Gomez, the plaintiff also alleged an express warranty claim under the LPLA, and the Fifth Circuit found that Louisiana law “goes beyond merely enforcing the federal requirements,” but “requires proof that ‘the express warranty was untrue.’” 442 F.3d at 932 (quoting La.Rev.Stat. §9:2800.58). Thus, the duties arising under the Louisiana breach of warranty statute are potentially inconsistent with the federal regulatory scheme. Id. Louisiana’s federal district courts have consistently applied Gomez in finding that express warranty claims under the LPLA are preempted. See, e.g., Gavin v. Medtronic, Inc., 2013 WL 3791612, at *16 (E.D. La. Jul. 19, 2013); 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). 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, Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 27 of 43 PageID #: 756 17 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 v. Hologic, Inc., 2010 WL 3021528 at *3-4 (W.D. La. 2010) (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 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. Alternatively, Plaintiff also fails to plead a proper claim for breach of express warranty under Twombly. To establish a breach of express warranty claim, a plaintiff must show that (1) there was an express warranty made by the manufacturer about the product; (2) the express warranty induced the plaintiff to use the product; and (3) the plaintiff’s damage was proximately caused because the express warranty was untrue. Parra v. Coloplast Corp., 2017 WL 24794 (E.D.La. Jan. 3, 2017) (dismissing breach of express warranty claim under Twombly) (citing La. Stat. Ann. § 9:2800.58; see also Caboni v. Gen. Motors Corp., 278 F.3d 448, 452 (5th Cir. 2002)). Here, Plaintiff’s Amended Complaint makes no such allegations. 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 ¶¶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. Plaintiff alleges in boilerplate fashion that the Globus SECURE-C is “guaranteed against faulty materials and workmanship,” but fails Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 28 of 43 PageID #: 757 18 to allege this statement was made by Globus to Plaintiff and Plaintiff was induced by it. In addition, although Plaintiff quotes some language supposedly used by Globus in its “advertis[ing]” and “market[ing],” Plaintiff fails to allege how this purported express warranty caused his injuries. Accordingly, even if the express warranty claim were not preempted, it is not sufficiently stated and must be dismissed. D. Plaintiff’s Redhibition, and Negligence Claims Are Preempted By The MDA, But Also Fail Due to the Exclusivity of the LPLA and Plaintiff’s Failure to State a Claim. Plaintiff’s claims for redhibition and negligence are both expressly premised on violation of state law (La.C.C. Art. 2520, et seq., and La. C.C. Arts. 2315, 2316, 2317, 2317.1, 2320, 2322, and 2324, respectively), and like express warranty claims are similarly preempted by the MDA. 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); Jefferson v. Lead Indus. Ass’n, Inc., 930 F.Supp. 241, 245 (E.D.La.1996) aff’d, 106 F.3d 1245 (5th Cir. 1997)(“neither negligence, strict liability, nor breach of express warranty is any longer viable as an independent theory of recovery against a manufacturer.”) Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 29 of 43 PageID #: 758 19 As stated above, Plaintiff alleges a claim for redhibition pursuant to La.C.C. Art. 2520, et seq. The Fifth Circuit has held that the theory of redhibition “is Louisiana’s equivalent to a breach of implied warranty claim.” Gomez, 442 F.3d at 931. District courts in Louisiana that have considered the application of the LPLA in medical device cases have also concluded that all causes of action asserted outside of the LPLA framework are not viable as independent theories of recovery, and must be dismissed. Gavin, 2013 WL 3791612, at *15. Plaintiff’s redhibition/breach of implied warranty claim is outside of the LPLA framework, and therefore no longer a viable claim against a manufacturer in Louisiana. Id. at *16; see also Scianneaux v. St. Jude Medical S.C., Inc., 961 F.Supp.2d 808, 811 (E.D.La. 2013)(“[s]imilarly, breach of implied warranty is unavailable as a theory of recovery for personal injury.”) Therefore, Plaintiff’s redhibition claim must be dismissed. Likewise, Plaintiff attempts to assert negligence theories of recovery that fall outside the LPLA.11 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. ¶¶42-44. All of these claims fail under Louisiana law due to the exclusivity of the LPLA. See Gavin, 2013 WL 3791612, at *15 (dismissing negligence and strict liability claims because only remedy available to plaintiff are provided in LPLA). Aside from the exclusivity of the LPLA, the negligence claims fail because they are preempted by the MDA and also fail to state a claim for which relief can be granted. See Sons, 915 F. Supp.2d 776. In Sons, the Louisiana District court concluded that plaintiff’s failure to 11 It is clear that these claims are not made under the LPLA or as a result of any violation of federal regulations, because Plaintiff specifically pleads this claim “in the alternative” of and “[a]lternatively” to the preceding causes of action. Compl. ¶¶42-44. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 30 of 43 PageID #: 759 20 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 522 U.S. at 327-28, and citing in support, Gomez, 442 F.3d at 926 (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: “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. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 31 of 43 PageID #: 760 21 E. Plaintiff’s Manufacturing Defect Claim is Preempted by the MDA But Plaintiff Also Fails to Allege Sufficient Facts To Support That Claim. 1. Plaintiff Fails To Identify A Defect Which Existed At The Time of Manufacture And Simply Describes The Core’s Condition After Explant. Notwithstanding the preemption of Plaintiff’s manufacturing defect claims, alternatively, dismissal is appropriate because Plaintiff’s Amended Complaint fails to state a claim for relief “that is plausible on its face.” Iqbal, 556 U.S. at 677; Twombly, 550 U.S. at 570; see also Cuvillier, 503 F.3d at 401. To the extent that the Court determines that Plaintiff’s manufacturing defect claims are preempted, it is not necessary to address the plausibility of Plaintiff’s claim 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, 550 U.S. at 555. Factual allegations must be enough to raise a right to relief above the speculative level. Id. (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 Amended Complaint. Id. (citing Papasan v. Allain, 478 U.S. 265, 286 (1986)). Plaintiff’s Amended Complaint makes conclusory allegations and fails to plead sufficient facts under Iqbal and Twombly. 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). In accordance with the Court’s Order, Plaintiff received pre-complaint discovery. Plaintiff also took the opportunity to inspect the subject device for more than two months. Globus produced the SECURE-C product specifications and drawings and the complete Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 32 of 43 PageID #: 761 22 manufacturing records for the subject device, including the Core. Those records included, inter alia, a “Certificate of Compliance” which certified that the Core was manufactured to the product specifications. The manufacturing records confirm that the subject device, including the Core, met all of the approved specifications at the time of manufacture and distribution. Importantly, Plaintiff does not rely upon or cite to the Core manufacturing records in support of his manufacturing defect claim. The reason is they do not support his claim. Instead, Plaintiff relies upon documents that were created after the subject device was explanted and an FDA mandated investigation and evaluation were conducted by Globus. Plaintiff has intentionally misled this Court by failing to identify or attach the documents from which he took the description of the Core’s condition and by failing to acknowledge that the documents describe the condition of the Core after explant and not at the time of manufacture or distribution. In doing so, Plaintiff expected this Court to believe that Plaintiff’s Amended Complaint describes the condition of the Core at the time of manufacture and distribution. Plaintiff relies on an Evaluation Report by a Globus engineer who inspected the subject device after it was removed from the Plaintiff’s spine and/or the FDA MAUDE Report which includes the results of that evaluation. See Exhibit A and B. Plaintiff uses identical language from the Evaluation Report without crediting the source. Specifically, the Globus engineer noted that the “core showed loss of uniform spherical curvature of the superior bearing surface,” “circular deformation…within the bearing surface and…on the anterior non-bearing flange[,]… [d]eformation…on the anterior inferior aspect of the core’s bearing surface… [and] deformation in the lower regions of recess features.” See Exhibit B at GM000480, compare to Compl. ¶27. Plaintiff further alleges that these deformations caused the core to escape from the endplates (Compl. ¶28), but Plaintiff does not explain how that happened or how that is causally connected to any alleged injury. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 33 of 43 PageID #: 762 23 As described in detail above, Globus’ Evaluation Report of the subject device and the FDA MAUDE Report both describe the condition of the Core after it was explanted. The Evaluation Report and FDA MAUDE Report do not describe the condition of the Core at the time of manufacture or distribution. In simply describing the condition of the Core after it was removed from the Plaintiff’s spine over thirty (30) days after it was implanted, the Plaintiff does not allege sufficient facts to properly plead a manufacturing defect claim. Plaintiff has failed to identify the existence of a manufacturing defect of the Core at the time of manufacture or distribution. Therefore, Plaintiff’s Amended Complaint fails to state a manufacturing defect claim “that is plausible on its face” and it should be dismissed. 2. The Very Documents Plaintiff Relies Upon Conclude That The Subject Device Was Manufactured Within The FDA Approved Product Specifications. Plaintiff’s Amended Complaint is devoid of any factual allegations, other than conclusory statements, supporting Plaintiff’s claim that the subject device, specifically the Core, was not manufactured to the product specifications. Plaintiff’s manufacturing defect claim depends on the device being defective at the time of manufacture or at the time it was placed into the stream of commerce. Plaintiff alleges that the subject device lacked “uniform spherical curvature” “at the time it left the control of Globus.” Compl. ¶27. This statement is directly contradicted by the very documents upon which Plaintiff relies. The Globus Evaluation and the FDA Report describe the Core’s condition at the time of explant. These documents do not describe the Core as having any deformations or defects at the time of manufacture or distribution. In fact, both the Evaluation and FDA Report conclude that the subject device, including the Core, was manufactured within the product specifications and therefore confirm that it was not defective at the time of manufacture or distribution. The FDA Report specifically states that: Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 34 of 43 PageID #: 763 24 “A review was conducted of all applicable material records, manufacturing records, storage records, and distribution records according to the descriptions of the product used with the concomitant device. All records revealed all product lots were manufactured within specifications, maintained and distributed in accordance with all federal, state and operating procedures.” See Exhibit A. Likewise, the Globus Evaluation specifically concludes that: “A review of the Device History Record and further dimensional analysis per the product inspection sheet concluded that the implant returned was manufactured per specifications.” See Exhibit B. Plaintiff’s claim that the Core was not manufactured to product specifications and was defective at the time of manufacture or distribution is directly contradicted by the documents relied upon in the Amended Complaint. In fact, these documents confirm that no such defect existed. Accordingly, Plaintiff’s manufacturing defect claim does not rise to the plausibility standard required by Twombly and must be dismissed. F. Plaintiff’s Amended Complaint Does Not State a Manufacturing Defect Claim That Survives Preemption. 1. GMP Violations Cannot Serve As The Basis For A Parallel State Claim. As most courts have recognized, Good Manufacturing Practices violations “cannot serve as the basis for a parallel claim” that avoid express preemption because GMPs are “intentionally vague and open-ended,” and are “open to a particular manufacturer’s interpretation.” Ilarraza v. Medtronic, Inc., 677 F.Supp. 2d 582, 588 (E.D.N.Y. 2009); see also Cenac v. Hubbell, 2010 WL 4174573, at *4-5 (E.D. La. Oct. 21, 2010) (in granting a preemption based motion to dismiss, the court concluded that 21 C.F.R. § 820.72, as well as three other GMPs cited, did not impose any specific requirements related to the defendant’s manufacturing process or the particular device at issue).12 12 See also Pearsall v. Medtronics, Inc., 2015 WL 8160888, at *7 (E.D.N.Y. 2015) (“The GMPs are guidelines that do not create a federal requirement, and a claim based on alleged failure to comply with the guidelines fails to plead a violation of a federal requirement.”); Burkett v. Smith & Nephew GmbH, 2014 WL 1315315, at *5 (E.D.N.Y. 2014) (“Because [plaintiff’s] manufacturing defect claim is based on violation of generally applicable CGMPs, as opposed to federal requirements specific to the [device at issue], preemption bars the claim.”); Hernandez v. Stryker Corp., 2014 WL 7044171, at *5-7 (W.D. Wash. 2014) (GMPs cannot support a parallel claim); Horn v. Boston Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 35 of 43 PageID #: 764 25 The FDA itself recognized that these requirements “are intended to serve only as ‘an umbrella quality system,’ providing ‘general objectives’ medical-device manufacturers must seek to achieve.” Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 278-79 (E.D.N.Y. 2009) (citations omitted) (quoting FDA Device Advice, Good Manufacturing Practices/Quality System Regulation).13 These regulations do not specifically address the design, production and marketing requirements for each and every type of medical device. Id. The GMP requirements leave it up to the manufacturer to institute a quality control system specific to the medical device it produces to ensure that such device is safe and effective. Id. Accordingly, both GMP regulations cited by Plaintiff are too vague to support a parallel claim. Cenac, 2010 WL 4174573, at *4-5. 2. Plaintiff Does Not Dispute That Globus Has Established and Maintained Procedures In Compliance With The Federally Prescribed GMPs. To survive express preemption, a parallel state law claim that is premised on a violation of a FDA regulation, Plaintiff must show that the violation of a FDA regulation rendered the SECURE-C “unreasonably dangerous.” See Reigel, 552 U.S. at 330. The alleged violation must also be causally connected to an injury giving rise to a state law right of action. McBride, 2013 WL 3491085 at *3 (citing Godfrey, 2011 WL 7768092). Moreover, the allegations that Globus violated FDA regulations must satisfy the pleading requirements of Twombly. See Bass, 669 F.3d at 509-10 (affirming that “to plead a parallel claim successfully, a plaintiff’s allegations that the manufacturer violated FDA regulations must meet the Twombly plausibility standard”). Scientific, 2011 WL 3893812, at *9 (S.D. Ga. 2011) (“Because [GMPs] fail to provide any tangible or concrete standard, this court agrees that to allow a violation of such a flexible standard to result in liability would, in itself, be imposing a standard “different from, or in addition to” those imposed by the [Medical Device Amendments].”) quoting 21 U.S.C. § 360k(a)(1)); James v. Diva Int’l, Inc., 803 F. Supp. 2d 945, 950-51 (S.D. Ind. 2011) (finding the FDA’s QSR and GMPs “insufficient to warrant federal preemption”); In re Medtronic Inc. Sprint Fidelis Leads Prods. Liab. Litig, 592 F. Supp. 2d 1147, 1158 (D. Minn. 2009) (“The flexibility inherent in the CGMPs and QSR demonstrates why Plaintiffs’ manufacturing-defect claims are not ‘parallel.’”) 13 The Horowitz opinion states that the quoted document was available at http://www.fda.gov/cdrh/devadvice/ 32.html#flexibility and last visited by the Court on January 2, 2009. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 36 of 43 PageID #: 765 26 Louisiana district courts routinely dismiss alleged parallel claims for manufacturing defect as preempted where these pleading requirements are not met. See, e.g., Parra. 2017 WL 24794, at *3 (failure to connect alleged violation of federal manufacturing requirements to manufacturing defect resulted in preemption by MDA); Skinner v. St. Jude Medical, Inc., 2016 WL 4054931, at *3 (W.D. La. July 27, 2016) (dismissing amended complaint for alleging conclusory parallel claims); Williamston v. Medtronic, Inc., 2014 WL 2042004, *7 (W.D. La. May 15, 2014) (granting leave to amend complaint but acknowledging that complaint failed to state parallel claim where plaintiff merely listed “various federal regulations” without specificity)14 Although Plaintiff avers that upon the removal of the subject device from the Plaintiff’s spine, it showed “loss of uniform spherical curvature” as well as other deformations, Plaintiff does not identify how the device deviated from the manufacturing requirements approved by the FDA in the PMA process or what in the manufacturing process went wrong that resulted in the deformations. (Compl. ¶27) See Bass, 669 F.3d at 510 (the plaintiff must at least specify with particularity what went wrong in the manufacturing process and cite the relevant FDA manufacturing standards the defendant allegedly violated.)(citations omitted); Funk, 631 F.3d at 782. Moreover, Plaintiff’s Amended Complaint does not specify the causal connection between the failure of a specific manufacturing process and the specific manufacture defect that allegedly caused injury. See Funk, 631 F.3d at 782. Instead, Plaintiff simply alleges that Globus failed to detect that the subject Core was defective at the time of manufacture or distribution and allowed the device that allegedly “fails to conform to the requirements for a pre-market approved [sic] allowing the non-conforming 14 See also Gavin, 2013 WL 3791612, at *17 (dismissing manufacturing defect claim for failure to identify violations of federal regulations and provide allegations connecting these violations to plaintiff’s specific injury); Scianneaux v. St. Jude Medical S.C., Inc., 961 F.Supp.2d 808 (E.D.La. 2013) (dismissing with prejudice amended complaint for failure to specify the federal regulations that defendant violated or how the device deviated from its specifications); McBride, 2013 WL 3491085, at *3 (dismissing manufacturing claim for failure to identify violation of federal regulations). Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 37 of 43 PageID #: 766 27 SUBJECT DEVICE to enter into the stream of commerce and to be implanted into BREAUX…” Compl. ¶30. Plaintiff claims that in doing so Globus has violated two federally prescribed GMPs: 21 C.F.R. §820.72 “Inspection, Measuring, and Test Equipment” and §820.90 “Nonconforming Product.” However, the referenced GMPs do not set forth the specifications to which the SECURE- C is required to conform. Rather, the cited GMPs only set forth guidelines for the manufacturer to follow in establishing certain manufacturing protocols and procedures, specific to its own device. Section 820.72(a) requires manufacturers to establish procedures for inspection, measuring and test equipment. It requires, in part, that each manufacturer shall ensure that all inspection, measuring, and test equipment,…is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, … 21 C.F.R. 820.72(a)(emphasis added). Subsection (b) requires, in part, that “[c]alibration procedures shall include specific directions and limits for accuracy and precision.” Section 820.90 likewise provides guidelines for manufacturers to follow in establishing procedures regarding nonconforming products. It states, in relevant part, that: Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. … Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. … Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 38 of 43 PageID #: 767 28 21 C.F.R. § 820.90(a)-(b)(emphasis added). The cited GMPs only require that the manufacturer establish and maintain protocols and procedures specific to its own device. Other than general guidelines, it does not set forth specifications that each manufacturer must explicitly adopt. This is significant because the Plaintiff does not allege that Globus failed to establish, maintain and implement these procedures and protocols for the SECURE-C. In fact, Globus has produced its Standard Operating Procedures (“SOP”), which confirm that Globus has established and maintained procedures which specifically comply with 21 CFR 820.72 and 820.90. See SOP 7.6 “Control of Monitoring and Measuring Devices Procedure” and SOP 8.3 “Control of Nonconforming Product Procedure.” Moreover, Globus has produced its manufacturing records for the subject device which confirm that those procedures were followed. Plaintiff’s Amended Complaint states the general proposition that it was a violation of the GMPs for the subject device to be placed in the stream of commerce. Compl. ¶30. Plaintiff does not cite to a specific federal regulations that was violated that caused the alleged manufacturing defect. Plaintiff’s general allegation is too vague under Twombly to support Plaintiff’s claim that Globus violated federal regulation by not identifying an alleged non-conforming product. See In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig., 592 F. Supp. 2d 1147, 1158 (D. Minn. 2009)(“Merely alleging that Medtronic failed to comply with the CGMPs/QSR by using spot welding is insufficient without some factual detail about why that violates federal standards.”) To the extent that Plaintiff claims that Globus’ own standards and procedures were deficient, such a claim does not allege a violation of a federal regulation. As the District Court held in Godfrey, plaintiff “improperly premised liability on deviations from [the manufacturer’s] own specifications or performance standards, not on the manufacturer’s deviations from federal requirements.” 2011 WL 7768092, at *8. Courts “will not strain credulity and manufacture a Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 39 of 43 PageID #: 768 29 claim” based on deviations from federal manufacturing requirements where one “does not exist in the [complaint].” See McQuiston, 2009 WL 4016120, *7 (W.D. La.)(holding that even filing in Louisiana state court, which requires only fact pleading, does not save a plaintiff’s claim that a manufacturer violated FDA regulations where no such claims exist in the complaint). 3. Plaintiff Has Not Met The Pleading Threshold Necessary To Allege A Violation of a Federal Regulation. To the extent the GMPs are considered, as noted in Williamston v. Medtronic, Inc., the “key distinction between complaints that are sufficient to withstand a motion to dismiss and those that are not, is not reliance on the GMPs, but rather the existence of a manufacturing defect caused by a violation of federal regulations and allegations connecting a defect in the manufacture of the specific device to that plaintiff’s specific injury.” 2014 WL 2042004 at *5 (W.D. La. May 15, 2014) (emphasis in original and added)(citations omitted). As discussed at length above, Plaintiff has not alleged facts supporting its claim that the Core was defective at the time of manufacture or distribution nor has he alleged sufficient facts that a defect was caused by the violation of a federal regulation. Plaintiff simply has described the condition of the Core at the time it was explanted from Plaintiff’s spine, over 30 days after it was implanted and the documents upon which Plaintiff relies confirm that the subject device was manufactured to product specifications. Plaintiff has not stated a claim for a violation of a federal regulation that is plausible on its face and it should be dismissed. To the extent the Plaintiff challenges the suitability of the precise processes or procedures chosen by the manufacturer, and approved by the FDA, to achieve the broader regulatory goals, such a claim could not proceed.” Bass, 669 F.3d at 512. Here, Plaintiff merely pleads that the subject device lacked “uniform spherical curvature.” Compl. ¶30. This is not specific enough to establish noncompliance with the FDA approved manufacturing processes. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 40 of 43 PageID #: 769 30 To survive a motion to dismiss, the claim must be “based upon manufacturing defects resulting from violations of federal regulations.” Bass, 669 F.3d at 510 (quoting In re Medtronic, 623 F.3d at 1207)(noting that a plaintiff must plead that the manufacturer “violated a federal requirement specific to the FDA's PMA approval of th[e] Class III device” and concluding that classwide claims of generic manufacturing defects do not survive a motion to dismiss)). Plaintiff fails to comply with the pleading standard adopted by the Bass court because he fails to identify a federal requirement specific to the FDA’s PMA approval that was allegedly violated, even though Globus has produced the FDA approved product specifications and drawings and corresponding manufacturing records of the subject device. As the Court in In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig., pointed out: Rollins v. St. Jude Medical, 583 F.Supp.2d 790 (W.D.La.2008), provides an example of the types of allegations sufficient to survive preemption under Twombly. There, the plaintiff alleged that the defendant had failed to comply with the device’s PMA specifications requiring the device to be “packaged with [its] anchor in vertical position with the bypass tube, neither extending beyond the end of the tube nor inserted deeply within it,” by “incorrectly pack[ing][it] with a .038” guidewire as opposed to the required .035 “guidewire.” Id. at 800. 592 F. Supp. 2d at 1158-59. No similarly detailed allegations appear in the Complaint here. Plaintiff’s claim that Globus violated a federal regulation is limited to the conclusory statement, without factual support, that Globus failed “to identify a non-conforming product.” Plaintiff’s lack of detail does not rise to the Twombly standard and his claim must be dismissed. V. CONCLUSION As the Court well knows, this Court allowed Plaintiff to conduct pre-complaint discovery to attempt to establish an exception to preemption in the form of a manufacturing defect claim premised on a violation of a specific federal requirement. Globus provided the Plaintiff with nearly 600 pages of documents and the subject device for inspection and allowed Plaintiff several months to amend his pleadings. As reflected in this Memorandum and as shown by Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 41 of 43 PageID #: 770 31 particular reference to the comprehensive documents produced (supra at 7-8), Plaintiff has failed in his second attempt to allege any plausible or lawful claims against Globus. Accordingly, the Amended Complaint should be dismissed with prejudice. 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 Email: 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 53 Filed 10/16/17 Page 42 of 43 PageID #: 771 CERTIFICATE OF SERVICE I hereby certify that on this day, 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. Dated: October 13, 2017 s/ Andrew L. Plauché, Jr. Case 6:16-cv-00872-DDD-CBW Document 53 Filed 10/16/17 Page 43 of 43 PageID #: 772