Bertroch v. Smith & Nephew

MOTION to Dismiss Based upon Plaintiffs claims are preempted

D. Del.November 11, 2016

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE JESSIE BERTROCH and CINDY BERTROCH, Plaintiffs, v. SMITH & NEPHEW, INC., Defendant. Case No. 1:16-cv-00712-LPS DEFENDANT SMITH & NEPHEW, INC.’S MOTION TO DISMISS PLAINTIFFS’ COMPLAINT Defendant Smith & Nephew, Inc. (“Smith & Nephew”), by its undersigned counsel, and pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure, respectfully moves this Court to enter an Order dismissing Plaintiffs Jessie and Cindy Bertroch’s Complaint, with prejudice, for the following reasons: First, Plaintiffs’ Complaint must be dismissed with prejudice because Plaintiffs’ claims are preempted by federal law. Each of Plaintiffs’ claims is expressly preempted by the Medical Device Amendments of 1976, 21 U.S.C. § 360k(a), as interpreted by the U.S. Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because Plaintiffs’ claims with respect to a Class III medical device approved by the Food and Drug Administration (“FDA”) pursuant to the rigorous premarket approval process seek to impose state-law requirements that are different from, or in addition to, the requirements imposed by the FDA. Moreover, Plaintiffs’ claims based solely on federal regulations are impliedly preempted pursuant to Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 344 (2001), as Plaintiffs lack a private right of action Case 1:16-cv-00712-LPS Document 7 Filed 11/11/16 Page 1 of 2 PageID #: 27 2 to enforce these regulations. Plaintiffs have failed to assert a valid “parallel” state law claim that would survive express and implied preemption. Second, Plaintiffs’ strict liability claim (Count I) must be dismissed with prejudice because Delaware does not recognize strict products liability claims. Third, Plaintiffs fail to plead their claims with sufficient factual specificity to satisfy Federal Rule of Civil Procedure 8(a) and the controlling U.S. Supreme Court case law, Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009). For these reasons, which are more fully set forth in the accompanying Memorandum of Law in Support of Defendant Smith & Nephew, Inc.’s Motion to Dismiss Plaintiffs’ Complaint, Smith & Nephew respectfully requests that this Court grant its Motion to Dismiss, and enter an Order dismissing Plaintiffs’ Complaint with prejudice. Dated: November 11, 2016 Respectfully submitted, By: /s/ John C. Cordrey John C. Cordrey (No. 5324) REED SMITH LLP 1201 Market Street, Suite 1500 Wilmington, DE 19801 Tel.: (302) 778-7500 Fax: (302 778-7575 Glenn S. Kerner, Esq. (pro hac vice) Nilda M. Isidro, Esq. (pro hac vice) GOODWIN PROCTER LLP The New York Times Building 620 Eighth Avenue New York, NY 10018 Tel.: (212) 813-8800 Fax: (212) 355-3333 gkerner@goodwinlaw.com nisidro@goodwinlaw.com Attorneys for Defendant Smith & Nephew, Inc. Case 1:16-cv-00712-LPS Document 7 Filed 11/11/16 Page 2 of 2 PageID #: 28 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE JESSIE BERTROCH and CINDY BERTROCH, Plaintiffs, v. SMITH & NEPHEW, INC., Defendant. Case No. 1:16-cv-00712-LPS Filed: November 11, 2016 MEMORANDUM OF LAW IN SUPPORT OF DEFENDANT SMITH & NEPHEW, INC.’S MOTION TO DISMISS PLAINTIFFS’ COMPLAINT John C. Cordrey (No. 5324) REED SMITH LLP 1201 Market Street, Suite 1500 Wilmington, DE 19801 Tel.: (302) 778-7500 Fax: (302) 778-7575 Glenn S. Kerner, Esq. (pro hac vice) Nilda M. Isidro, Esq. (pro hac vice) GOODWIN PROCTER LLP The New York Times Building 620 Eighth Avenue New York, NY 10018 Tel.: (212) 813-8800 Fax: (212) 355-3333 Attorneys for Defendant Smith & Nephew, Inc. Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 1 of 26 PageID #: 29 i TABLE OF CONTENTS SUMMARY OF ARGUMENT .......................................................................................................1 STATEMENT OF PROCEEDINGS AND FACTS ........................................................................3 ARGUMENT ...................................................................................................................................4 I. PLAINTIFFS’ CLAIMS ARE EXPRESSLY PREEMPTED BY THE MEDICAL DEVICE AMENDMENTS ..................................................................................................4 A. Federal Regulatory Scheme Applicable to the BHR System...................................4 B. All of Plaintiffs’ Claims Challenge the Safety and Effectiveness of the BHR System and Thus Are Preempted by Federal Law..........................................5 II. CLAIMS BASED SOLELY ON FEDERAL REQUIREMENTS ARE IMPLIEDLY PREEMPTED PURSUANT TO BUCKMAN ..............................................8 A. There Is No Private Right of Action To Enforce Purported FDCA Violations .................................................................................................................8 B. Plaintiffs’ Claims of Purported CGMP Violations Are Preempted Pursuant to Buckman ..............................................................................................................9 III. PLAINTIFFS HAVE FAILED TO STATE A “PARALLEL” CLAIM THAT SURVIVES PREEMPTION ..............................................................................................10 A. Plaintiffs Have Not Identified a “Parallel” State-Law Claim ................................10 B. CGMP Violations Cannot Serve As the Basis for “Parallel” Claims ....................11 IV. PLAINTIFFS’ STRICT LIABILITY CLAIM IS INVALID UNDER DELAWARE LAW ...........................................................................................................15 V. PLAINTIFFS’ CLAIMS ARE INADEQUATELY PLEADED UNDER FEDERAL LAW ...............................................................................................................15 A. Federal Pleading Standard Applicable to Plaintiffs’ Claims .................................15 B. Plaintiffs Do Not Allege Sufficient Facts To Support Their Claims .....................18 CONCLUSION ..............................................................................................................................20 Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 2 of 26 PageID #: 30 ii TABLE OF AUTHORITIES Page(s) CASES Ashcroft v. Iqbal, 556 U.S. 662 (2009) ......................................................................................................... passim Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) ......................................................................................................... passim Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 250 ...............................................................................................................7 Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) ......................................................................................................... passim Burkett v. Smith & Nephew Gmbh, 2014 WL 1315315 (E.D.N.Y. Mar. 31, 2014) .....................................................................7, 12 Desabio v. Howmedica Osteonics Corp., 817 F. Supp. 2d 197 (W.D.N.Y. 2011) ..................................................................................4, 7 Franzese v. St. Jude Med., Inc., 2014 WL 2863087 (E.D.N.Y. June 23, 2014) .................................................................2, 7, 12 Hernandez v. Stryker Corp., 2014 WL 7044171 (W.D. Wash. Dec. 11, 2014) ....................................................................12 Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y. 2009) .....................................................................................13 Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582 (E.D.N.Y. 2009) ...............................................................................11, 12 In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147 (D. Minn. 2009), aff’d, 623 F.3d 1200 (8th Cir. 2010) ....................7, 12 Kaiser v. DePuy Spine, Inc., 2013 WL 2006122 (M.D. Fla. May 14, 2013) ...................................................................13, 14 McPhee v. DePuy Orthopedics, Inc., 2013 WL 5462762 (W.D. Pa. Sept. 30, 2013) .........................................................................13 Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ...................................................................................................................6 Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 3 of 26 PageID #: 31 iii Morris v. Greenky et al., Index No. 2015EF2603, slip op. (N.Y. Sup. Ct. Onondaga Cnty. Feb. 10, 2016) ............13, 14 Pearsall v. Medtronics, Inc., 2015 WL 8160888 (E.D.N.Y. Dec. 7, 2015) ................................................................... passim Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ......................................................................................................... passim Simmons v. Boston Scientific Corp., 2013 WL 1207421 (C.D. Cal. Mar. 25, 2013) .........................................................................13 Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395 (S.D.N.Y. 2013), recon. denied, 18 F. Supp. 3d 423 (2014) ....................7 STATUTES, RULES, AND REGULATIONS 21 U.S.C. § 301, et. seq....................................................................................................................4 21 U.S.C. § 337(a) .......................................................................................................................2, 8 21 U.S.C. § 360c(a)(1) .....................................................................................................................6 21 U.S.C. § 360k(a) ............................................................................................................... passim 21 C.F.R. § 814.20 ...........................................................................................................................4 Federal Rule of Civil Procedure 8(a) .............................................................................2, 16, 17, 19 Federal Rule of Civil Procedure 12(b)(6) ..................................................................................1, 16 Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 4 of 26 PageID #: 32 1 SUMMARY OF ARGUMENT Defendant Smith & Nephew, Inc. (“Smith & Nephew”) submits this memorandum in support of its Motion to Dismiss Plaintiffs’ Complaint pursuant to Fed. R. Civ. P. 12(b)(6). In their Complaint, Plaintiffs Jessie Bertroch and Cindy Bertroch allege various claims against Smith & Nephew in connection with Mr. Bertroch’s hip resurfacing surgery. Plaintiffs allege that the Smith & Nephew “Birmingham Hip Resurfacing System” (the “BHR System”)- a medical device used in hip surgeries-was implanted in Mr. Bertroch and subsequently had to be revised. (See Compl. ¶ 1.) As is demonstrated below, Plaintiffs’ Complaint is fatally flawed for several reasons: their claims are preempted by federal law, their strict liability claim is barred by Delaware law, and each of their claims fails to meet the federal pleading standard. Plaintiffs’ claims are expressly preempted by the Medical Device Amendments of 1976 (“MDA”). The BHR System is a Class III medical device, approved by the United States Food and Drug Administration (“FDA”) pursuant to the rigorous premarket approval (“PMA”) process. In light of the stringent safety review process that Class III medical devices must undergo to obtain PMA approval, the MDA includes a provision expressly preempting state law causes of action against manufacturers of Class III medical devices to the extent the causes of action impose requirements different from, or in addition to, the requirements of federal law. 21 U.S.C. § 360k(a). The United States Supreme Court has so held in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Plaintiffs’ Complaint seeks to impose requirements different from, or in addition to, federal requirements and, therefore, must be dismissed with prejudice. In an effort to circumvent express preemption, Plaintiffs assert purported violations of Current Good Manufacturing Practices (CGMPs)-federal regulations applicable to all medical device manufacturers. However, the federal government has exclusive authority to enforce the Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 5 of 26 PageID #: 33 2 MDA and its regulations, see 21 U.S.C. § 337(a), and the Supreme Court has held that attempts by private litigants to enforce these federal requirements are preempted. See Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 347-53 (2001). Since Plaintiffs’ claims are based solely on federal regulations, they are impliedly preempted and must be dismissed. Plaintiffs further attempt to dodge both express and implied preemption by making conclusory allegations that the federal CGMPs “parallel” state-law duties. However, the broad CGMPs Plaintiffs list are insufficient to support a “parallel” claim that could survive federal preemption of state-law claims. See, e.g., Nevolas v. Boston Scientific Corp., 2016 WL 347721, at *3 (W.D. Okla. Jan. 28, 2016); Franzese v. St. Jude Medical, Inc., 2014 WL 2863087, at *4- 5 (E.D.N.Y. June 23, 2014). Accordingly, Plaintiffs’ claims do not escape preemption and must be dismissed with prejudice. Furthermore, Plaintiffs’ strict liability claim is invalid under Delaware law. Delaware does not recognize strict products liability claims, so courts regularly and immediately dismiss these claims. See, e.g., LeJeune v. Bliss-Salem, Inc., 85 F.3d 1069, 1072 (3d Cir. 1996); Nationwide Mut. Fire Ins. Co. v. Sears, Roebuck & Co., 2008 WL 613145, at *2 (D. Del. Mar. 5, 2008). Accordingly, this Court should dismiss Count I of the Complaint with prejudice. Finally, Plaintiffs fail to plead each of their claims with the specificity required by Federal Rule of Civil Procedure 8(a) and the controlling United States Supreme Court case law, Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009). The Complaint is patently devoid of factual allegations to support Plaintiffs’ conclusory claims that Smith & Nephew violated federal regulations. Thus, Plaintiffs’ Complaint is also subject to dismissal for failure to meet the pleading standard. Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 6 of 26 PageID #: 34 3 For these reasons, Smith & Nephew respectfully requests that the Court enter an order dismissing Plaintiffs’ Complaint in its entirety, with prejudice. STATEMENT OF PROCEEDINGS AND FACTS Plaintiffs filed their Complaint in the United States District Court for the District of Delaware on August 12, 2016. (D.I. 1.) The Complaint alleges that Plaintiff Mr. Bertroch underwent left hip resurfacing surgery on February 22, 2007 and, subsequently, “in or about the summer of 2014,” “X-rays revealed lucency around his cup and a large pariacetabular lesion,” and “[b]lood tests showed metal ion levels.” (Compl. ¶ 13) He underwent revision surgery on August 12, 2014. (Compl. ¶ 14.) 1 The Complaint contains three counts, each based on purported CGMP violations: strict products liability (Count I); negligence (Count II); and loss of consortium (Count III). The BHR System that Plaintiffs allege caused them injury was submitted for approval pursuant to the PMA process and was granted approval by the FDA on May 9, 2006. (See FDA Premarket Approval Summary, PMA Number P040033, attached hereto as Exhibit A; see also Compl. ¶ 10.) 2 FDA approval of the BHR System pursuant to the rigorous PMA process means 1 Based on the dates alleged in the Complaint, Smith & Nephew anticipates that this case might be subject to dismissal on statute of limitations grounds. In Delaware, there is a two-year statute of limitations for personal injury claims, running from the date the plaintiff discovers, or reasonably should have discovered, the possible cause of his or her injury. See Simms v. Freeman, 428 F. App’x 119, 120 (3d Cir. 2011); Dickens v. Taylor, 671 F. Supp. 2d 542, 547 (D. Del. 2009). Mr. Bertroch’s revision surgery took place on August 12, 2014 - exactly two years before the Complaint was filed. Smith & Nephew anticipates that limited discovery would reveal whether Mr. Bertroch knew, or had reason to know, of the basis of his claims prior to August 12, 2014. However, the Court need not reach the anticipated statute of limitations issue because the Complaint should be dismissed with prejudice for the reasons set forth in the instant Motion. Smith & Nephew reserves, and specifically does not waive, its right to seek dismissal of Plaintiffs’ Complaint on this additional ground. 2 This Court may take judicial notice of the BHR System approval documents because they are located on an official government website (the FDA’s website) at: http://www.accessdata.fda. gov/cdrh_docs/pdf4/P040033A.pdf. See, e.g., Scanlon v. Medtronic Sofamor Danek USA Inc., 61 F. Supp. 3d 403, 413 n.16 (D. Del. 2014) (taking judicial notice of document available on Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 7 of 26 PageID #: 35 4 that the BHR System has been deemed safe and effective by the FDA, pursuant to the requirements of the MDA, 21 U.S.C. § 301, et. seq. (See Ex. A.) ARGUMENT I. PLAINTIFFS’ CLAIMS ARE EXPRESSLY PREEMPTED BY THE MEDICAL DEVICE AMENDMENTS A. Federal Regulatory Scheme Applicable to the BHR System The MDA, 21 U.S.C. § 301, et. seq., governs FDA-approved medical devices such as the BHR System. The FDA groups prescription medical devices into three classes. 21 U.S.C. § 360c(a)(1). Class III devices, which are the most closely-scrutinized by the FDA, must undergo a rigorous pre-market approval process before they can be marketed. Riegel v. Medtronic, Inc., 552 U.S. 312, 317-18 (2008). The FDA has promulgated numerous regulations regarding PMA requirements for Class III medical devices. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 343 (2001). These regulations require that a PMA applicant produce comprehensive data- including human clinical trials, design specifications, manufacturing processes, quality controls, and proposed labeling and advertising-from which the FDA can make a reasoned determination of the device’s safety and effectiveness. 21 C.F.R. § 814.20; see also Riegel, 552 U.S. at 318 (citing 21 U.S.C. §§ 360c(a)(2)(B), 360e(d)(l)(A)). “The FDA spends an average of 1,200 hours reviewing each application” and only grants PMA approval when it has “‘reasonable assurance’ of the device’s ‘safety and effectiveness’ . . . .” Riegel, 552 U.S. at 318 (citing 21 U.S.C. § 360e(d)). FDA website that “reflects final agency action and is included in a database maintained by the FDA in the normal course of business”); see also, e.g., Desai v. Sorin CRM USA, Inc., 2013 WL 163298, at *4 (D.N.J. Jan. 15, 2013) (“This Court takes judicial notice of the FDA’s website, and holds that it establishes premarket approval of the [device].”); Desabio v. Howmedica Osteonics Corp., 817 F. Supp. 2d 197, 201 n.3 (W.D.N.Y. 2011) (taking judicial notice of PMA number and approval from FDA website after defendants cited FDA website in motion to dismiss). Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 8 of 26 PageID #: 36 5 Even after PMA approval, the FDA retains strict oversight over Class III devices. A manufacturer may not change “design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness” without first obtaining the FDA’s authorization. Id. at 319 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). A manufacturer must receive supplemental PMA from the FDA for any changes, and the FDA evaluates the proposed changes “under largely the same criteria as an initial application.” Id. (citing 21 U.S.C. § 360e(d)(6); 21 C.F.R. § 814.39(c)). Class III devices are also subject to post-approval reporting requirements, including informing the FDA of new studies, investigations, or incidents where the device caused or could have caused serious injury. Id at 319. The FDA retains the authority to withdraw approval based upon such new information. Id. at 319-20. Congress has provided protection for Class III medical devices based on the rigorous PMA review and approval process. Id. at 316. Pursuant to § 360k(a) of the MDA, state-law causes of action against manufacturers of Class III medical devices are expressly preempted to the extent they impose requirements different from, or in addition to, those under federal law: [N]o State . . . may establish or continue in effect with respect to a device intended for human use any requirement - (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. 21 U.S.C. § 360k(a); see Riegel, 552 U.S. at 316 (same). Under this regulatory scheme, Plaintiffs’ claims are expressly preempted and must be dismissed with prejudice. B. All of Plaintiffs’ Claims Challenge the Safety and Effectiveness of the BHR System and Thus Are Preempted by Federal Law Plaintiffs’ Complaint asserts various purported counts as to the safety and effectiveness of the BHR System. As established above, Smith & Nephew’s BHR System was approved via Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 9 of 26 PageID #: 37 6 the PMA process on May 9, 2006, and deemed to be safe and effective pursuant to the stringent MDA requirements. (See Ex. A; Compl. ¶ 10.) Section 360k(a) therefore applies, and all of Plaintiffs’ claims must be dismissed as expressly preempted by federal law. In Riegel, the Supreme Court affirmed the United States Court of Appeals for the Second Circuit’s dismissal of the plaintiffs’ complaint. 552 U.S. at 320-21, 330. The Court held that Class III medical devices approved pursuant to the FDA’s exacting and comprehensive PMA process are exempt from common-law claims that seek to impose requirements different from, or in addition to, FDA-imposed requirements, id. at 330, in reliance on the MDA’s express preemption provision, id. at 328 (citing 21 U.S.C. § 360k(a)). The Riegel Court held that the PMA process imposes device-specific requirements relating to safety and effectiveness: “Premarket approval . . . imposes ‘requirements’ under the MDA as we interpreted it in [Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)]. Unlike general labeling duties, premarket approval is specific to individual devices. And it is in no sense an exemption from federal safety review-it is federal safety review.” Id. at 322-23 (emphasis added). The Court further stated that “common-law liability is ‘premised on the existence of a legal duty,’ and a tort judgment therefore establishes that the defendant has violated a state-law obligation.” Id. at 324 (citing Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 522 (1992) (plurality opinion)). Pursuant to Riegel, a claim brought under state law that challenges the safety and effectiveness of a PMA device imposes a “requirement” that is specifically preempted by § 360k(a). Id. at 323-27. The Court concluded that the state-law duties were requirements that challenged the safety and effectiveness of the FDA-approved device and, accordingly, dismissed the plaintiffs’ state-law tort claims. Id. Since Riegel, “courts across the country have applied Section 360k(a) broadly, Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 10 of 26 PageID #: 38 7 preempting all manner of claims from strict products liability and negligence, to breach of warranty, to failure to warn and manufacturing-and-design-defect, to negligence per se.” See, e.g., In re Medtronic, Inc. Sprint Fidelis Leads Products Liab. Litig., 592 F. Supp. 2d 1147, 1152 (D. Minn. 2009) (internal citations omitted) (listing cases), aff’d, 623 F.3d 1200 (8th Cir. 2010). This includes the United States Court of Appeals for the Third Circuit, this Court, and numerous federal and state courts that have addressed the issue. See Williams v. Cyberonics, Inc., 388 F. App’x 169, 171-72 (3d Cir. 2010) (holding plaintiff’s negligence, failure-to-warn, negligent misrepresentation, and fraud claims against defendant medical device manufacturer were preempted by the MDA pursuant to Riegel); Scanlon, 61 F. Supp. 3d 403, 410-13 (dismissing all claims involving PMA-approved device as preempted pursuant to Riegel); see also, e.g., Nagel v. Smith & Nephew, 2016 WL 4098715, at *6-8 (D. Conn. July 28, 2016); Gates v. Medtronic, Inc., 2016 WL 3636902, at *6 (W.D. Tex. June 29, 2016); Becker v. Smith & Nephew, Inc., 2015 WL 4647982, at *2-3, *5 (D.N.J. Aug. 5, 2015); Pearsall, 147 F. Supp. 3d at 193-202; Lindler v. Mentor Worldwide LLC, 2014 WL 6390307, at *2 (D.S.C. Oct. 23, 2014); Vitale v. Medtronic, Inc., 2014 WL 3893294, at *2 (C.D. Cal. Aug. 8, 2014); Franzese, 2014 WL 2863087, at *4-8; Burkett v. Smith & Nephew Gmbh, 2014 WL 1315315, at *4-9 (E.D.N.Y. Mar. 31, 2014); Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 254-61 (E.D.N.Y. 2014); Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395, 403-08 (S.D.N.Y. 2013), recon. denied, 18 F. Supp. 3d 423 (2014); Desabio, 817 F. Supp. 2d at 202-06. As set forth above, Smith & Nephew’s BHR System was approved on May 9, 2006 as a Class III device pursuant to the PMA process, and was determined to be safe and effective pursuant to the MDA requirements. (See Ex. A.) Accordingly, to the extent Plaintiffs bring claims against Smith & Nephew under state law that challenge the safety and effectiveness of the Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 11 of 26 PageID #: 39 8 BHR System, Plaintiffs’ Complaint must be dismissed as expressly preempted by federal law. II. CLAIMS BASED SOLELY ON FEDERAL REQUIREMENTS ARE IMPLIEDLY PREEMPTED PURSUANT TO BUCKMAN A. There Is No Private Right of Action To Enforce Purported FDCA Violations To the extent Plaintiffs seek to bring claims that are grounded solely in federal requirements, Plaintiffs lack a private right of action for such claims. Only the federal government may seek redress against a manufacturer for alleged violations of the federal Food, Drug, and Cosmetic Act or its implementing regulations. 21 U.S.C. § 337(a) (“[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter [i.e., the FDCA] shall be by and in the name of the United States.”). Thus, the U.S. Supreme Court held in Buckman Co. v. Plaintiffs’ Legal Committee that there is no private right of action under the FDCA. 531 U.S. at 349 n.4 (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized to file suit for noncompliance with the [law].”). Numerous other courts, including this one, have so held. See Scanlon, 61 F. Supp. 3d at 411 (“In light of the Riegel and Buckman preemption schemes, courts have generally agreed that there is a narrow path that plaintiffs must follow to successfully assert state-law claims against medical device manufacturers. In order to survive preemption, such claims must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the FDCA.” (emphasis added) (internal quotation marks omitted)) (listing cases); see also, e.g., Pearsall v. Medtronics, Inc., 147 F. Supp. 3d 188, 194 (E.D.N.Y. 2015) (a claim must be “based on ‘conduct that violates the FDCA . . ., but not because the conduct violates the FDCA.’” (alteration in original) (quoting In re Medtronic, Inc. Sprint Fidelis Leads Products Liab. Litig., 623 F.3d at 1204))). “Plaintiffs cannot simply incant the magic words ‘[Defendants] violated FDA regulations’ in order to avoid preemption.” Wolicki-Gables v. Arrow Int’l, Inc., Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 12 of 26 PageID #: 40 9 634 F.3d 1296, 1301 (11th Cir. 2011) (citation and internal quotation marks omitted). Rather, the plaintiff’s claim “must arise from an actual state-law requirement; it cannot exist solely by virtue of the FDCA . . . requirements.” Pearsall, 147 F. Supp. 3d at 199 (citation and internal quotation marks omitted). In other words, the claim “must be premised on conduct that . . . would give rise to a recovery under state law even in the absence of the FDCA.” Perdue v. Wyeth Pharms., Inc., 2016 WL 3951091, at *5 (E.D.N.C. July 20, 2016) (emphasis added) (citation and internal quotation marks omitted). Thus, claims that merely try to enforce FDA regulations are preempted. See Mink v. Smith & Nephew, Inc., 169 F. Supp. 3d 1321 (S.D. Fla. Mar. 14, 2016). B. Plaintiffs’ Claims of Purported CGMP Violations Are Preempted Pursuant to Buckman As the basis for each count in the Complaint, Plaintiffs state that Smith & Nephew violated a list of Current Good Manufacturing Practices (CGMPs), 3 the FDA’s regulations applicable to all medical device manufacturers. But Plaintiffs’ claims based on alleged violations of these CGMPs are impliedly preempted. Under Buckman, claims that arise “solely from the violation of FDCA requirements” are preempted; “the existence of [] federal enactments” cannot be “a critical element in [the plaintiffs’] case.” 531 U.S. at 352-53. Here, the Complaint concedes that Plaintiffs’ claims are “based on an exclusively federal statutory and regulatory set of requirements[.]” (Compl. ¶ 20 (emphasis added); see also id. ¶ 1 (“This is a strict products liability, negligence, and loss of consortium action arising out of Defendant Smith & Nephew’s violations of various sections of the Federal Code of Regulations and the damages suffered . . . as a result thereof.”); id. ¶ 16 (“The BHR . . . was designed and/or manufactured in 3 Plaintiffs’ Complaint lists 21 C.F.R. § 820.30(f)-(g); 21 C.F.R. § 820.80(c)-(d); 21 C.F.R. § 820.100; and 21 C.F.R. § 820.198. Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 13 of 26 PageID #: 41 10 violation of the Federal Food, Drug and Cosmetic Act (the ‘Act’) and regulations promulgated pursuant to it.”).) Because Plaintiffs’ claims are expressly predicated on Smith & Nephew’s alleged failure to comply with the FDCA and because the FDA retains sole authority to enforce such purported violations, Plaintiffs’ claims are preempted. As this Court has previously held, “[w]hile such conduct . . . might violate the FDCA, such conduct would not exist apart from the FDCA. . . . Therefore, these causes of action [] are preempted.” Scanlon, 61 F. Supp. 3d at 412; see also, e.g., Frere v. Medtronic, Inc., 2016 WL 1533524, at *7 (C.D. Cal. Apr. 6, 2016) (dismissing CGMP claims as impliedly preempted pursuant to Buckman “because Plaintiff’s entire claim rests on conduct Plaintiff claim[s] . . . violated the FDA’s CGMPs.”); Pearsall, 147 F. Supp. 3d at 198-202 (holding claims based on FDCA violations were impliedly preempted because the “authority to enforce [those] claim[s] rests with the FDA”). Accordingly, Plaintiff’s CGMP claims are impliedly preempted pursuant to Buckman and must be dismissed with prejudice. III. PLAINTIFFS HAVE FAILED TO STATE A “PARALLEL” CLAIM THAT SURVIVES PREEMPTION A. Plaintiffs Have Not Identified a “Parallel” State-Law Claim As Riegel makes clear, state-law claims that seek to impose requirements “different from, or in addition to,” federal requirements are expressly preempted by § 360k. 552 U.S. at 330. But “§ 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.” Id. (emphasis added) (citation omitted). “To state a parallel claim, a plaintiff must show that the state requirement was ‘genuinely equivalent’ to the federal requirement.” Grubbs v. Synthes, 2016 WL 360610, at *3 (M.D. Fla. Jan. 19, 2016) (quoting Wolicki-Gables, 634 F.3d at 1300). Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 14 of 26 PageID #: 42 11 Apparently recognizing that their claims are expressly preempted pursuant to Riegel, and also trying to circumvent implied preemption pursuant to Buckman, Plaintiffs proclaim that their list of federal CGMP violations is “parallel” to state-law requirements. But Plaintiffs’ conclusory assertion that the alleged violation of the FDA requirements also violates “parallel” state-law duties does not save their claims from preemption. Plaintiffs “may not attempt to recast a claim for violation of the FDCA as a state-law . . . claim simply by pleading it as such.” Mink, 169 F. Supp. 3d at 1335 (citation and internal quotation marks omitted). Rather, as noted on p. 8 supra, they must show that there is a “parallel” state-law duty that exists independently of federal requirements-i.e., that the failure to comply with CGMPs would violate state law “apart from the FDCA.” Scanlon, 61 F. Supp. 3d at 412; see also Norman v. Bayer Corp., 2016 WL 4007547, at *4 (D. Conn. July 26, 2016) (no parallel claim if state law would not give rise to liability “even if the FDCA had never been enacted.”) (emphasis added) (citation and internal quotation marks omitted)). Plaintiffs have failed to do so. B. CGMP Violations Cannot Serve As the Basis for “Parallel” Claims Additionally, Plaintiffs’ claims for purported violations of federal law fail because the slew of federal requirements listed in the Complaint are broad federal CGMP applicable to all medical devices, rather than requirements specific to the device Plaintiffs allege is at issue in this case-the BHR System. As many courts have held, these broad manufacturing requirements cannot render a state-law claim “parallel” to federal law. For example, the court in Ilarraza v. Medtronic, Inc. ruled that the plaintiff had failed to successfully plead a parallel claim “because no regulation relied upon refer[red] specifically to the medical device at issue” in the case. 677 F. Supp. 2d. 582, 588 (E.D.N.Y. 2009). “Instead, each regulation cited is nothing more than a general statement of [] CGMP’s.” Id. (emphasis added). The court noted that these regulations simply cannot serve as a basis for parallel claims Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 15 of 26 PageID #: 43 12 because of their “intentionally vague and open-ended nature.” Id. Allowing CGMPs to serve as a basis for parallel claims would lead to different courts establishing different safety requirements for medical devices, which “would necessarily result in the imposition of standards that are ‘different from, or in addition to’ those imposed by the [Medical Device Amendments of 1976 (“MDA”)]-precisely the result that the MDA preemption provision seeks to prevent.” Id. (emphasis added); see also In re Medtronic, 592 F. Supp. 2d at 1158. Numerous other courts have held the same. See, e.g., In re Medtronic, 592 F. Supp. 2d at 1157 (“[CGMPs] are simply too generic, standing alone, to serve as the basis for Plaintiffs’ manufacturing-defect claims. The CGMPs and [Quality System Regulation] require manufacturers to develop their own quality-system controls to ensure that medical devices are safe and effective for their intended use, and they are inherently flexible.”) (emphasis in original); Nevolas, 2016 WL 347721, at *3 (“The Court finds plaintiff’s allegations that defendant was required to follow non-specific federal regulations and current good manufacturing practice requirements, which are applicable to all manufacturers of all medical devices, are insufficient to state a plausible parallel claim upon which relief can be granted.”), Franzese, 2014 WL 2863087, at *4-5 (citing Desabio, 817 F. Supp. 2d at 204) (“Plaintiffs must identify a specific federal regulation allegedly violated”; reliance on CGMPs is insufficient.); Burkett, 2014 WL 1315315, at *5 (dismissing state-law claims because plaintiff failed to “allege a violation of federal requirements specific to the . . . device at issue. Rather, [plaintiff] relie[d] on [a] violation of CGMPs,” and, therefore, her state-law claims were preempted); Pearsall, 147 F. Supp. 3d at 198 (“The CGMPs are guidelines that do not create a federal requirement, and a claim based on alleged failure to comply with the guidelines fails to plead violation of a federal requirement.”); Hernandez v. Stryker Corp., 2014 WL 7044171, at Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 16 of 26 PageID #: 44 13 *5-7 (W.D. Wash. Dec. 11, 2014) (plaintiffs failed to state parallel claims based on CGMPs); McPhee v. DePuy Orthopedics, Inc., 2013 WL 5462762, at *6-7 (W.D. Pa. Sept. 30, 2013) (ruling that “vague references to general FDA manufacturing requirements” were insufficient to state a parallel claim); Simmons v. Boston Scientific Corp., 2013 WL 1207421, at *4-5 (C.D. Cal. Mar. 25, 2013) (“Plaintiffs must do more than baldly assert that the device violated federal standards.”); Kaiser v. DePuy Spine, Inc., 944 F. Supp. 2d 1187, 1191-92 (M.D. Fla. May 14, 2013) (holding that general allegation of violation of FDA performance standards were insufficient to plead a parallel claim); Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 283-84 (E.D.N.Y. 2009) (ruling that plaintiff’s reliance on defendant’s CGMP violations “does not save these claims from preemption as such requirements are simply too generic, standing alone, to serve as the basis” for her claim (internal citations and quotation marks omitted)); Morris v. Greenky, Index No. 2015EF2603, slip op. at 6 (N.Y. Sup. Ct. Onondaga Cnty. Feb. 10, 2016) (attached hereto as Exhibit B) (holding, in a case involving the same device as in this case-the BHR System-that “[s]tate law claims based upon alleged violations of broad [CGMP] regulations, without explaining how Defendant violated Federal law with respect to the BHR System, are not parallel claims and are therefore pre-empted”); Lutz-Cummings v. Medtronic, Inc., 2016 WL 3082314, at *5 (Minn. Dist. Ct. May 31, 2016) (“To state a parallel claim that escapes express preemption under Section 360k . . ., Plaintiffs must allege facts pointing to specific PMA requirements that Defendants violated that caused the specific alleged injury.”). In fact, the FDA itself explains that CGMPs “apply to so many different types of devices, [and] the regulation[s] do[] not prescribe in detail how a manufacturer must produce a specific device.” See Quality System (QS) Regulation/Medical Device Good Manufacturing Practices, FDA, http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarket Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 17 of 26 PageID #: 45 14 requirements/qualitysystemsregulations/ (last updated July 29, 2016) [hereinafter “Medical Device Good Manufacturing Practices, FDA”]. 4 Importantly, the FDA states that “CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures.” See Facts About the Current Good Manufacturing Practices (CGMPs), FDA, http://www.fda.gov/Drugs/DevelopmentApproval Process/Manufacturing/ucm169105.htm (last updated Jan. 6, 2015) (emphasis added); see also Medical Device Good Manufacturing Practices, FDA, supra. The inherent flexibility in CGMPs is why federal and state courts have held that they cannot serve as a basis for parallel claims- because the federal requirements are flexible, a state law mandating that a device manufacturer act in a certain way necessarily is “different from, or in addition to,” the federal requirement, and therefore expressly preempted pursuant to Riegel. See, e.g., Morris, Ex. B, slip op. at 6 (“[W]e are not satisfied that Plaintiffs identified a specific regulation with respect to the BHR system which Defendant violated. . . . [T]hese Federal regulations are left ‘flexible’ in order to allow production of specialized medical devices and do not serve to establish any State duty.”). Thus, any state-law claims based on alleged violations of these broad regulations, without explaining how Smith & Nephew purportedly violated federal law specific to the BHR System, are not parallel claims and cannot escape preemption. See, e.g., Kaiser, 944 F. Supp. 2d at 1191-92 (“To properly allege parallel claims, the complaint must set forth facts pointing to specific PMA requirements that have been violated.”) (citation and internal quotation marks omitted). Such claims seek to impose requirements different from, or in addition to, federal law, and, therefore, are preempted pursuant to Riegel. 4 This Court may take judicial notice of information located on the FDA website, as discussed supra, n.2. Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 18 of 26 PageID #: 46 15 Therefore, Plaintiffs’ claims which are specifically based on CGMP violations do not state a parallel claim, and must be dismissed with prejudice. 5 IV. PLAINTIFFS’ STRICT LIABILITY CLAIM IS INVALID UNDER DELAWARE LAW Delaware does not recognize strict products liability claims. See, e.g., LeJeune v. Bliss- Salem, Inc., 85 F.3d 1069, 1072 (3d Cir. 1996); Nationwide Mut. Fire Ins. Co. v. Sears, Roebuck & Co., Civ..A. No 07-153 JJF, 2008 WL 613145, at *2 (D. Del. Mar. 5, 2008). Therefore, Count I in the Complaint fails as a matter of Delaware law and must be dismissed with prejudice. See LeJeune, 85 F.3d at 1072 (citing Cline v. Prowler Indus. of Maryland, Inc., 418 A.2d 968 (Del. 1980)) (“Applying Delaware law, we can immediately dispose of Appellants’ product liability claim. Appellants’ claim fails because Delaware does not recognize strict products liability.”); Nationwide Mut. Fire Ins. Co., 2008 WL 613145, at *2 (dismissing claim for strict products liability, because “[t]he Delaware Legislature and Supreme Court have both refused to impose a doctrine of strict tort liability for defective products.”). V. PLAINTIFFS’ CLAIMS ARE INADEQUATELY PLEADED UNDER FEDERAL LAW A. Federal Pleading Standard Applicable to Plaintiffs’ Claims In Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009), the United States Supreme Court expressly articulated the federal pleading standard 5 Plaintiffs’ third count attempts to state a claim for loss of consortium. However, “[u]nder Delaware law a loss of consortium claim is derivative to that of the injured spouse and is dependent upon the existence of a valid claim by the injured spouse for physical injury against the tortfeasor.” D’Alessandro v. Progressive N. Ins. Co., 2008 WL 4276201, at *2 (D. Del. Sept. 17, 2008) (citations omitted). Accordingly, Plaintiffs’ derivative claim for loss of consortium cannot be based on claims for relief that are preempted by federal law. See id. (holding that consortium claim was “extinguished” when plaintiff no longer had valid claims). Therefore, for the reasons stated in sections I-III, supra, Plaintiffs’ loss of consortium count must be dismissed with prejudice. Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 19 of 26 PageID #: 47 16 applicable to Plaintiffs’ Complaint. For a complaint to survive a Rule 12(b)(6) motion to dismiss, the “[f]actual allegations must be enough to raise a right to relief above the speculative level[.]” Twombly, 550 U.S. at 555. Under the Twombly standard, a proper pleading “requires more than labels and conclusions[.]” Id. The “threshold requirement of Rule 8(a)(2)” is that the complaint “possess enough heft to show that the pleader is entitled to relief.” Id. at 557 (internal quotation marks and alterations omitted). A plaintiff must plead “enough facts to state a claim to relief that is plausible on its face.” Id. at 570; see also Boring v. Google Inc., 362 F. App’x 273, 277-78 (3d Cir. 2010) (delineating pleading standard under Twombly and Iqbal). Unless a plaintiff “nudge[s] [his] claims across the line from conceivable to plausible, [his] complaint must be dismissed.” Twombly, 550 U.S. at 570; see also Mann v. Brenner, 375 F. App’x 232, 235 (3d Cir. 2010) (quoting Twombly, 550 U.S. at 570). In Ashcroft v. Iqbal, the Supreme Court established a two-step process based on Rule 8(a) for determining whether a complaint meets the standard to survive a motion to dismiss. 556 U.S. at 680-81. First, the court must identify those allegations that, because they are no more than conclusions, are not entitled to the assumption of truth. See id. “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice,” id. at 678 (citing Twombly, 550 U.S. at 555), nor do “formulaic recitation[s] of the elements of [the] cause[s] of action” with no facts to support the claims, see Twombly, 550 U.S. at 555; Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 555). “While legal conclusions can provide the framework of a complaint, they must be supported by factual allegations.” Iqbal, 556 U.S. at 679. Complaints comprised of “‘naked assertion[s]’ devoid of ‘further factual enhancement’” are plainly insufficient. Id. at 678 (quoting Twombly, 550 U.S. at 557). Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 20 of 26 PageID #: 48 17 Second, the court should assume the truth of well-pleaded factual allegations, if the complaint contains any, and determine whether they plausibly give rise to an entitlement to relief. See id. at 681. “[W]here the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged - but has not ‘show[n]’ - ‘that the pleader is entitled to relief,’” and it, therefore, should be dismissed. Id. at 679 (quoting Fed. R. Civ. P. 8(a)(2)). The Rule 8 pleading standard requires “more than an unadorned, the defendant- unlawfully-harmed-me accusation.” Id. at 678 (citing Twombly, 550 U.S. at 555). Courts must dismiss complaints that assert only “a sheer possibility that a defendant has acted unlawfully.” Id. The Third Circuit regularly applies Twombly and Iqbal at the pleading stage, conducting a three-part inquiry when it reviews a complaint: “(1) identifying the elements of the claim, (2) reviewing the complaint to strike conclusory allegations, and then (3) looking at the well- pleaded components of the complaint and evaluating whether all of the elements identified in part one of the inquiry are sufficiently alleged.” Jackson v. Whalen, 568 F. App’x 85, 86-87 (3d Cir. 2014) (citation and internal quotation marks omitted); see also Malleus v. George, 641 F.3d 560, 563 (3d Cir. 2011); Montague v. Sherwood, 2015 WL 9484465, at *2 (D. Del. Dec. 29, 2015). Indeed, a complaint must plead sufficient facts in support of each element of a claim. See Jackson, 568 F. App’x at 87; Endo Pharm. Inc. v. Actavis Inc., 2015 WL 5580488, at *3 (D. Del. Sept. 23, 2015), report and recommendation adopted, 2015 WL 7253674 (D. Del. Nov. 17, 2015) (explaining that Plaintiffs must “provide the grounds of their entitlement to relief beyond mere labels and conclusions”). In other words, a plaintiff must plead “‘enough facts to raise a reasonable expectation that discovery will reveal evidence [of the necessary] element.’” Homax Products, Inc. v. Old Magic Corp., 61 F. Supp. 3d 413, 418 (D. Del. 2014) (quoting Phillips v. Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 21 of 26 PageID #: 49 18 Cnty. of Allegheny, 515 F.3d 224, 234 (3d Cir. 2008) (alterations in original). The plaintiff’s claim to relief must be plausible on its face, requiring the plaintiff to show “’more than a sheer possibility that a defendant has acted unlawfully.’” Endo Pharm. Inc., 2015 WL 5580488, at *3 (quoting Iqbal, 556 U.S. at 678). The Court must reject “unsupported allegations, ‘bald assertions,’ and ‘legal conclusions.’” Id. at *2. (quoting Iqbal, 556 U.S. at 678). B. Plaintiffs Do Not Allege Sufficient Facts To Support Their Claims All three of Plaintiffs’ counts are based on purported violations of federal CGMPs. However, Plaintiffs fail to provide any factual support whatsoever for their vague allegations of CGMP violations. Therefore, each count must be dismissed as inadequately pleaded. “Under Delaware law, to state a claim for negligence, one must allege that defendant owed plaintiff a duty of care; defendant breached that duty; and defendant’s breach was the proximate cause of the plaintiff’s injury.” Hopkins v. Pusey, 475 F. Supp. 2d 479, 482 (D. Del. 2007) (citing New Haverford Partnership v. Stroot, 772 A.2d 792, 798 (Del. 2001)). Plaintiffs plead, in the most conclusory fashion, that Smith & Nephew violated a laundry list of CGMPs. But there are no facts in support of the required elements for a negligence claim under Delaware law. See id. Plaintiffs fail to identify how Smith & Nephew allegedly breached any duty, let alone the existence of an actual problem or defect in the BHR System. Additionally, Plaintiffs plead no facts regarding what made the specific BHR System allegedly used during Plaintiff Mrs. Balch’s surgery defective. Moreover, Plaintiffs do not plead how any purported problem with the device caused their purported injuries. Plaintiffs merely allege that Smith & Nephew had a “duty . . . to comply with the [FDCA]” and violated federal regulations notwithstanding such duty, followed by a laundry list of purported violations. (Compl. ¶ 25.) However, Plaintiffs fail to plead any factual support for these purported violations, and fail to plead how the violations caused the product to be defective and caused their claimed injuries. Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 22 of 26 PageID #: 50 19 Such conclusory allegations without factual support do not suffice to state a claim for negligence. 6 The recent decision in Spellman v. Smith & Nephew, Inc., also involving the BHR system, is illustrative. 2016 WL 5364206 (D. Ariz. Sept. 26, 2016). There, Plaintiffs’ complaint was strikingly similar to Plaintiffs’ Complaint in the instant case-including many verbatim paragraphs and alleged violations of the same CGMPs. See Complaint, Spellman v. Smith & Nephew, Inc., No. 3:16-cv-08080-DKD (D. Ariz. Sept. 26, 2016), ECF No. 1. The Spellman court analyzed the plaintiff’s complaint under Rule 8(a) and held that the plaintiff’s complaint “merely conclude[d], without any factual context, that [Smith & Nephew] violated the various listed regulations. On the face of Spellman’s complaint it is possible that [Smith & Nephew] violated the FDA’s regulations, but the complaint does not include any ‘factual enhancement’ to cross ‘the line between possibility and plausibility.’” 2016 WL 5364206, at *3; see also, e.g., Williamston v. Medtronic, Inc., 2014 WL 2042004 (W.D. La. May 15, 2014) (violation of allegedly “parallel” regulations insufficiently pleaded where plaintiff failed to allege sufficient factual support); Swisher v. Stryker Corp., 2014 WL 1153716 (W.D. Okla. March 14, 2014) (plaintiffs failed to adequately plead causation and the nature of the alleged violation of federal regulations). So too here, Plaintiffs have failed to provide any factual context for their bare-bones allegations that Smith & Nephew violated FDA regulations. Simply put, Plaintiffs have not pleaded “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570. Plaintiffs’ “naked assertions” that Smith & Nephew breached requirements imposed by 6 Although, as discussed supra, Delaware law prohibits Plaintiffs’ strict products liability claim, the Complaint likewise lacks any facts that would even support such a claim, including Plaintiffs’ baseless allegation that the BHR System was “unreasonably dangerous due to non- compliance” with the FDCA, causing Plaintiff Mr. Balch’s injury. (Compl. ¶¶ 17-18). Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 23 of 26 PageID #: 51 20 federal law are insufficient and do not provide a “plausible” basis to believe that Plaintiffs may be entitled to relief. Iqbal, 556 U.S. at 678 (2009) (citation and internal quotation marks omitted). Plaintiffs have utterly failed to plead “‘enough facts to raise a reasonable expectation that discovery will reveal evidence’” of their claims Homax Prod., Inc., 61 F. Supp. 3d at 418 (quoting Phillips, 515 F.3d at 234) (alterations in original). Accordingly, this Court should dismiss Plaintiffs’ Complaint as inadequately pleaded. 7 CONCLUSION For the foregoing reasons, Smith & Nephew respectfully requests that the Court enter an order granting Smith & Nephew’s Motion to Dismiss, dismissing Plaintiffs’ Complaint in its entirety, with prejudice. Dated: November 11, 2016 Respectfully submitted, By: /s/ John C. Cordrey John C. Cordrey (No. 5324) REED SMITH LLP 1201 Market Street, Suite 1500 Wilmington, DE 19801 Tel.: (302) 778-7500 Fax: (302 778-7575 Glenn S. Kerner, Esq. (pro hac vice) Nilda M. Isidro, Esq. (pro hac vice) GOODWIN PROCTER LLP The New York Times Building 620 Eighth Avenue New York, NY 10018 Tel.: (212) 813-8800 Fax: (212) 355-3333 gkerner@goodwinlaw.com nisidro@goodwinlaw.com 7 Plaintiffs plead loss of consortium allegations based on Smith & Nephew’s purported violation of federal law. However, as noted supra, n. 5 “a loss of consortium claim is derivative to that of the injured spouse and is dependent upon the existence of a valid claim by the injured spouse for physical injury against the tortfeasor.” D'Alessandro, 2008 WL 4276201, at *2 (internal citations omitted). Therefore, as each and every one of Plaintiffs’ underlying counts are invalid and/or insufficiently pleaded, the loss of consortium claim must also be dismissed. See id. Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 24 of 26 PageID #: 52 21 Attorneys for Defendant Smith & Nephew, Inc. Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 25 of 26 PageID #: 53 CERTIFICATE OF SERVICE I hereby certify that on November 11, 2016, I caused to be served by electronic means via the Court’s CM/ECF System a copy of the Memorandum of Law in Support of Defendant Smith & Nephew, Inc.’s Motion to Dismiss Plaintiffs’ Complaint on all counsel registered to receive electronic notices. _____________________ Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 26 of 26 PageID #: 54 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE JESSIE BERTROCH and CINDY BERTROCH, Plaintiffs, v. SMITH & NEPHEW, INC., Defendant. Case No. 1:16-cv-00712-LPS DECLARATION OF GLENN S. KERNER IN SUPPORT OF DEFENDANT SMITH & NEPHEW, INC.’S MOTION TO DISMISS PLAINTIFFS’ COMPLAINT I, Glenn S. Kerner, declare under penalty of perjury as follows: 1. I am an attorney at law of the State of New York and a partner of Goodwin Procter LLP, The New York Times Building, 620 Eighth Avenue, New York, NY 10018, attorneys for Defendant Smith & Nephew, Inc. in this action. I submit this declaration in support of Defendant Smith & Nephew, Inc.’s Motion to Dismiss Plaintiffs’ Complaint. 2. Attached hereto as Exhibit A is a true and correct copy of the May 9, 2006 Pre- Market Approval (“PMA”) Notification for PMA Number P040033, as found on the United States Food and Drug Administration’s (“FDA”) website at http://www.accessdata.fda.gov/cdrh _docs/pdf4/P040033A.pdf. 3. Attached hereto as Exhibit B is a true and correct copy of the unreported opinion, Morris v. Greenky, Index No. 2015EF2603, slip op. (N.Y. Sup. Ct. Onondaga Cnty. Feb. 10, 2016). Case 1:16-cv-00712-LPS Document 7-2 Filed 11/11/16 Page 1 of 3 PageID #: 55 2 I hereby declare under penalty of perjury that the foregoing is true and correct. Dated: November 11, 2016 /s/ Glenn S. Kerner Glenn S. Kerner Case 1:16-cv-00712-LPS Document 7-2 Filed 11/11/16 Page 2 of 3 PageID #: 56 CERTIFICATE OF SERVICE I hereby certify that on November 11, 2016, I caused to be served by electronic means via the Court’s CM/ECF System a copy of the Declaration of Glenn S. Kerner in Support of Defendant Smith & Nephew, Inc.’s Motion to Dismiss Plaintiffs’ Complaint on all counsel registered to receive electronic notices. _____________________ Case 1:16-cv-00712-LPS Document 7-2 Filed 11/11/16 Page 3 of 3 PageID #: 57 EXHIBIT A Case 1:16-cv-00712-LPS Document 7-3 Filed 11/11/16 Page 1 of 9 PageID #: 58 DEPARTMENT OF HEALTH&. HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850MAY - 9 2006 Mr. Marcos Velez-Duran Group Director, Regulatory and Clinical Affairs Smith & Nephew Orthopaedics 1450 Brooks Road Memphis, Tennessee 38116 Re: P040033 Birmingham Hip Resurfacing (BHR) System Filed: July 19, 2004 Amended: September 13, September 16, October 4, October 8, October 20, November 19, and December 8, 2004; January 28, January 31, May 2, July 20, August I. August 15, September 26, October 17, and December 7, 2005; February 21 and March 2, 2006 · Procode: NXT Dear Mr. Velez-Duran: The Center for Devices and Radiological Health (CDRl-1) of the Food and Drug Administration (FDA) has completed its review of your prcmarket approval application (PMA) for the Birmingham Hip Resurfacing (Bl-IR) System. The Bl-IR System is a single use device intended for hybrid fixation: cemented temoral head component and cementless acetabular component. The Bl-IR system is intended for use in. patients requiring primary hip resurfacing arthroplasty due to: • Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis. traumatic arthritis, avascular necrosis, or dysplasia/developmental dislocation of the hip (DDl-1). or • Inflammatory arthritis such as rheumatoid arthritis. The BHR System is intended for patients \\ho. due to their rdativelv nnmger age or incrL'ased acti,·ity leveL may not he suitable lc1r traditional total hip arthroplast\· due to an increased possibilitv of requiring future ipsilateral hip joint rL'vision. \\·1..' arc pleased to inform you that the P\L\ is apprun.·d. You ma: begin comnH:'TCial distribution of the dcYicc in accordancL' ''ith thL' c~'nditions lkscrihcd bdow and in the "Conditions of ..Ypproval" (enclosL'd). l A1 Case 1:16-cv-00712-LPS Document 7-3 Filed 11/11/16 Page 2 of 9 PageID #: 59 Page 2- Mr. Marcos Velez-Duran The sale, distribution, and use of this device are restricted to prescription use in accordance with 21 CFR 801.109 within the meaning of section 520(e) of the Federal Food, Drug, and Cosmetic Act (the act) under the authority of section 515(d)(1)(B)(ii) of the act. FDA has also determined that, to ensure the safe and effective use of the device, the device is further restricted within the meaning of section 520(e) under the authority of section 515(d)(1)(B)(ii), (1) insofar as the labeling specify the requirements that apply to the training of practitioners who may use the device as approved in this order and (2) insofar as the sale, distribution, and use must not violate sections 502( q) and (r) of the act. In addition to the post-approval requirements outlined in the enclosure, you have agreed to provide the following data every 6 months for the first two years and annually thereafter following PMA approval until completion of the post-approval studies and the submission of a final report: I. You have agreed to conduct a study to evaluate longer-term safety and effectiveness of the Birmingham Hip Replacement (BHR) System. This study is expected to include the first 350 consecutive cases of the 2,385 cases in the Overall McMinn Cohort that were included in the PMA. Patient pain, function. movement, revision status, and adverse events will be assessed at baseline and annually from five (5) years through ten (10) years post-op through the use of the Oswestry-Modified Harris Hip (OS HIP) patient self- assessment questionnaire. In addition, a clinical and radiographic examination will occur at ten (I 0) years post-op to evaluate adverse events, revisions. and evidence of any radiolucencies. osteolysis, or component position change. 2. You have agreed to conduct a study to evaluate the learning curve, training program. and longer-term safety and effectiveness of the BI-IR System in the United States. This study will assess the generalization of the experience from a single physician in the United Kingdom to medical practice in the United States. Results of this study will be retlected in the label in g. This study is expected to include 350 patients at up to 8 sites with a minimum of 35 patients per site. Investigational sites recruited to participate in this study will be comprised of a geographically diverse mix of academic. referraL and/or communitY based sites. Per the training program outlined in the PMA. inYestigators will be recruited from the ..Core Surgeon .. group \Vho will initially be trained em the 13!-IR System as well as !rom a group of other interested US Surgeons who arc subsequently trained bv the Core Surgeons. Clinical and r~tdiographic data \Yil! be assessed at baseline. annually through fin.~(.:') yc~1rs post-op. and at ten (I 0) years post-op. Pain. function. and range of motionc,·aluations ''ill he performed using the Harris llip Score assessment mctlhxi. Radiographs will he A2 Case 1:16-cv-00712-LPS Document 7-3 Filed 11/11/16 Page 3 of 9 PageID #: 60 Page 3- Mr. Marcos Velez-Duran collected to evaluate any radiolucencies, osteolysis, or component position change. In addition, revision and adverse event data will be collected. The subjects will be assessed in the interim years of six (6}through nine (9) years post-op by use of a "postcard" (mailed, e,mailed, or telephone call) questionnaire follow-up to assess each subject's general well-being, and to determine if the study components remain implanted or are revised. In addition, to further assess the safety of the BHR system, cobalt and chromium ion concentration in the blood and renal function data (such as creatinine, GFR, BUN), will be collected preoperatively and at the 1-, 4-, and I 0-year follow-up timepoints. 3. You have agreed to implement a training program, as outlined in the PMA. The training program includes quarterly investigator teleconferences or meetings for the first two years of the US study to provide a clinical update to investigators; to discuss study issues including adverse events; and to identify recommendations for improvement of the training program or labeling. If some investigators cannot attend the conference, you have agreed that these investigators will all be contacted by telephone or will be sent the "Investigator Feedback Form" so that individual feedback can be obtained. You have agreed to submit a summary of the minutes of the quarterly teleconferences/ physical meeting/ investigator feedback information as part of the report. 4. You have agreed to provide an analysis of adverse events and complaints (including MDRs) received regarding the BHR system. In addition, you agree to use this analysis to provide a justification for modifications to the training program. post-approval study. labeling, and/or device design. Any modification to the post-approval study, labeling. and/or device design will be submitted for FDA review and approval prior to implementation. Please be advised that the results of the post-approval studies, training program assessment. and adverse event analysis outlined in items 1-4 above must be. reflected in the labeling (via a supplement) when the post-approval study is completed. and/or at earlier timepoints. as needed. Expiration dating I(F this device has been established and approved at live years. CDRH does not evalaatc int(,rmation related to contract liability warranties. however you should be a\\·are that any such warranty statetnents n1ust he truthfuL accurate. and not misleading. and must be consistent \\ith applicable Federal and State laws. CDR! I \\ill notify the public of its decision to appron" your I'!Vl•\ by making availabk a summan ol"thc saktv and elkcti,·cness data upon which the appro, a! is based. The int(mnation can be t(nmd on the Fl ):\ CDR II Internet Homcl'age located at 3 A3 Case 1:16-cv-00712-LPS Document 7-3 Filed 11/11/16 Page 4 of 9 PageID #: 61 Page 4- Mr. Marcos Velez-Duran http://www.fda.gov/cdrhlpmapage.html. Written requests for this information can also be made to the Dockets Management Branch, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The written request should include the PMA number or docket number. Within 30 days from the date that this information is placed on the Internet, any interested person may seek review of this decision by requesting an opportunity for administrative review, either through a hearing or review by an independent advisory committee, under section 515(g) of the Federal Food, Drug, and Cosmetic Act (the act). Failure to comply with any postapproval requirement constitutes a ground for withdrawal of approval of a PMA. Commercial distribution of a device that is not in compliance with these conditions is a violation of the act. You are reminded that, as soon as possible and before commercial distribution of your device, you must submit an amendment to this PMA submission with copies of all approved labeling in final printed form. c! he labeling will not routinely be reviewed by FDA staff when PMA applicants include 'With their submission of the final printed labeling a cover letter stating that the final printed labeling is identical to the labeling approved in draft form. If the final printed labeling is not identical, any changes from the final draft labeling should be highlighted and explained in the amendment. All required documents should be submitted in triplicate, unless otherwise specified. to the address below and should reference the above PMA number to facilitate processing. PMA Document Mail Center (HFZ-40 l) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850 If you have any questions concerning this approval order, please contact Mr. John S. Goode at (301) 594-2036. extension 155. Sincerely yours. ~ctr~/L ~/ . ' Donna-Rea Tillman. Ph. D.. l'vi.P..-\. Director Ortlcc of De\' icc E\aluation Center for DcYicc~ and Radiological l kalth A4 Case 1:16-cv-00712-LPS Document 7-3 Filed 11/11/16 Page 5 of 9 PageID #: 62 Last Modified: 1-31-02 CONDITIONS OF APPROVAL PREMARKET APPROVAL APPLICATION (PMA) SUPPLEMENT. Before making any change affecting the safety or effectiveness of the device, submit a PMA supplement for review and approval by FDA unless the change is of a type for which a "Special PMA Supplement-Changes Being Effected" is permitted under 21 CFR 814.39( d) or an alternate submission is permitted in accordance with 21 CFR 814.39(e) or (f). A PMA supplement or alternate submission shall comply with applicable requirements under 21 CFR 814.39 of the final rule for Premarket Approval of Medical Devices. All situations that require a PMA supplement cannot be briefly summarized; therefore, please consult the PMA regulation for further guidance. The guidance provided below is only for several key instances. A PMA supplement must be submitted when unanticipated adverse effects, increases in the incidence of anticipated adverse effects, or device failures necessitate a labeling, manufacturing, or device modification. A PMA supplement must be submitted if the device is to be modified and the modified device should be subjected to animal or laboratory or clinical testing designed to determine if the modified device remains safe and effective. A "Special PMA Supplement- Changes Being Effected" is limited to the labeling, quality control and manufacturing process changes specilicd under 21 CFR 814.39( d)(2). It allows lor the addition oL but not the replacement of previously approved, quality control specifications and test methods. These changes may be implemented before FDA approval upon acknowledgment by FDA that the submission is being processed as a "Special PMA Supplement- Changes Being Effected." This procedure is not applicable to changes in device design, composition, specifications, circuitry, software or energy source. Alternate submissions permitted under 21 CFR 814.39(e) apply to changes that otherwise require approval of a PMA supplement before implementation of the change and include the use of a 30-dav PMA supplement or annual postapproval report (see below). FDA must have previously indicated in an advisory opinion to the affected industry or in correspondence with the applicant that the alternate submission is permitted for the change. Before such can occur. FDA and the I'M A applicant(s) involved must agree upon any needed testing protocol. test results. reporting ti.mnat. inlcll'!nation to he reported. and the alternate submission to be used. Alternate submissions permitted under 21 CI-'R g 1-L1'l(l) l{n· manufacturing process changes include the USL' or a ~0-day Notice. The manut:tcturer tnay distributL· the deY icc 30 days alter the date on "hich the FDA recci\es the· :;o.da' Notice. unkss the I'D\ n