Bertroch v. Smith & Nephew

REPLY BRIEF re MOTION to Dismiss Based upon Plaintiffs claims are preempted

D. Del.February 3, 2017

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: February 3, 2017 REPLY MEMORANDUM OF LAW IN FURTHER 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 11 Filed 02/03/17 Page 1 of 17 PageID #: 113 i TABLE OF CONTENTS PRELIMINARY STATEMENT .....................................................................................................1 ARGUMENT ...................................................................................................................................2 I. PLAINTIFFS’ CLAIMS ARE PREEMPTED BY FEDERAL LAW .................................2 II. PLAINTIFFS HAVE FAILED TO PLEAD A “PARALLEL” CLAIM .............................3 A. Bausch Is Distinguishable and Does Not Save Plaintiffs’ Claims ...........................4 B. Plaintiffs Rely on Cases That Directly Contradict Binding Precedent ....................5 C. Plaintiffs Identify No Parallel State-Law Duty ........................................................7 D. CGMP Violations Cannot Serve As the Basis for “Parallel” Claims ......................8 III. PLAINTIFFS HAVE FAILED TO ADEQUATELY PLEAD THEIR COUNTS ..............9 CONCLUSION ..............................................................................................................................10 Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 2 of 17 PageID #: 114 ii TABLE OF AUTHORITIES Page(s) CASES Aaron v. Medtronic, Inc., No. 1:13-CV-202, 2016 WL 5242957 (S.D. Ohio Sept. 22, 2016) .......................................5, 9 Ali v. Allergan USA, Inc., No. 1:12-cv-115, 2012 WL 3692396 (E.D. Va. Aug. 23, 2012) ...............................................9 Anderson v. Boston Scientific Corp., No. 1:12-CV-00762, 2013 WL 632379 (S.D. Ohio Feb. 20, 2013) ..........................................6 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ...............................................................................................................2, 4 Babayev v. Medtronic, Inc., No. 10-cv-2038, 2017 WL 90403 (E.D.N.Y. Jan. 6, 2017) .......................................................5 Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) .................................................................................................1, 4 Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) ...............................................................................................................2, 4 Bertini v. Smith & Nephew, Inc., No. 13 CIV. 0079(BMC), 2013 WL 6332684 (E.D.N.Y. July 15, 2013) .................................9 Boring v. Google, Inc., 362 F. App’x 273 (3d Cir. 2010) ...............................................................................................7 Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) ...................................................................................................................1 Comella v. Smith & Nephew, Inc., No. 1:13-CV-01850, 2013 WL 6504427 (N.D. Ill. Dec. 11, 2013) .......................................6, 7 Corwin v. Connecticut Valley Arms, Inc., 74 F. Supp. 3d 883 (N.D. Ill. 2014) ...........................................................................................6 DeBons v. Globus Med., Inc., No. 14-56455, 2016 WL 4363171 (9th Cir. Aug. 16, 2016) .....................................................3 Desabio v. Howmedica Osteonics Corp., 817 F. Supp. 2d 197 (W.D.N.Y. 2011) ......................................................................................6 Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 3 of 17 PageID #: 115 iii Ellis v. Smith & Nephew, Inc., No. 6:15-cv-545-TMC (D.S.C. Feb. 16, 2016), Doc. 52 ...........................................................8 Elmore v. Smith & Nephew, Inc., No. 1:12-CV-08347, 2013 WL 1707956 (N.D. Ill. Apr. 19, 2013) .......................................6, 7 Franklin v. Medtronic, Inc., No. 09-CV-02301REBKMT, 2010 WL 2543579 (D. Colo. May 12, 2010), report and rec. adopted, No. 09-CV-02301-REB-KMT, 2010 WL 2543570 (D. Colo. June 22, 2010) ........................................................................................................5, 7 Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012) ........................................................................................6 Grubbs v. Synthes, No. 8:15-cv-00443-T-27TGW, 2016 WL 360610 (M.D. Fla. Jan. 19, 2016) ........................8 Haffner v. Stryker Corp., No. 14-CV-00186-RBJ, 2014 WL 4821107 (D. Colo. Sept. 29, 2014) ...................................10 Homax Products, Inc. v. Old Magic Corp., 61 F. Supp. 3d 413 (D. Del. 2014) .............................................................................................7 Horn v. Boston Sci. Neuro. Corp., No, CV-409-074, 2011 WL 3893812 (S.D. Ga. Aug. 26, 2011) ...............................................9 Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d. 582 (E.D.N.Y. 2009) ..................................................................................8, 9 In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) ...................................................................................................9 Loreto v. Procter & Gamble Co., 515 F. App’x 576 (6th Cir. 2013) ..............................................................................................3 Mann v. Brenner, 375 F. App’x 232 (3d Cir. 2010) ...............................................................................................7 Mink v. Smith & Nephew, Inc., 169 F. Supp. 3d 1321 (S.D. Fla. 2016) ..................................................................................3, 8 Nagel v. Smith & Nephew, Inc., No. 3:15-cv-00927 (JAM), 2016 WL 4098715 (D. Conn. July 28, 2016) ................................2 Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199 (9th Cir. 2002) ...................................................................................................3 Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 4 of 17 PageID #: 116 iv Norman v. Bayer Corp., No. 3:16-cv-00253, 2016 WL 4007547 (D. Conn. July 26, 2016) ............................................8 Parker v. Stryker Corp., 584 F. Supp. 2d 1298 (D. Colo. 2008) .......................................................................................7 Pearsall v. Medtronics, Inc., 147 F. Supp. 3d 188 (E.D.N.Y. 2015) .......................................................................................4 Perdue v. Wyeth Pharm., Inc., No. 4:15-CV-208-FL, 2016 WL 3951091 (E.D.N.C. July 20, 2016) ........................................3 Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016) ...............................................................................................................2 Purcel v. Advanced Bionics Corp., No. 3:07-CV-1777-M, 2008 WL 3874713 (N.D. Tex. Aug. 13, 2008) .....................................8 Raab v. Smith & Nephew, Inc., 150 F. Supp. 3d 671 (S.D. W. Va. 2015) ...................................................................................6 Richardson v. Bayer Healthcare Pharm. Inc., No. 4:15-CV-00443-BLW, 2016 WL 4546369 (D. Idaho Aug. 30, 2016) ...............................3 Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ...................................................................................................................1 Rollins v. St. Jude Medical, 583 F. Supp. 2d 790 (W.D. La. 2008) ........................................................................................8 Scanlon v. Medtronic Sofamor Danek U.S. Inc., 61 F. Supp. 3d 403 (D. Del. 2014) .........................................................................................3, 7 Shuker v. Smith & Nephew PLC, No. 1306158, 2015 WL 1475368 (E.D. Pa. Mar. 31, 2015) ......................................................5 Smith v. St. Jude Med. Cardiac Rhythm Mgmt. Div., Civ. No. CCB-12-1746, 2013 WL 1104427 (D. Md. Mar. 13, 2013) .......................................6 Spellman v. Smith & Nephew, Inc., No. 3:16-cv-08080-DKD (D. Ariz. Apr. 28, 2016), ECF No. 1 ................................................7 Tillman v. Smith & Nephew, Inc., No. 1:12-cv-04977, 2012 WL 11660220 (N.D. Ill. Nov. 12, 2012) .........................................7 Tillman v. Smith & Nephew, Inc., No. 1:12-CV-04977, 2013 WL 3776973 (N.D. Ill. July 18, 2013) .......................................6, 7 Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 5 of 17 PageID #: 117 v Weaver v. Ethicon, Inc., No. 16CV257-GPC(BGS), 2016 WL 7098781 (S.D. Cal. Dec. 6, 2016)..................................6 White v. Stryker Corp., 818 F. Supp. 2d 1032 (W.D. Ky. 2011) .....................................................................................6 Williams v. Zimmer US Inc., No. 5:14-cv-468-F, 2015 WL 4256249 (E.D.N.C. July 14, 2015) ............................................3 Winkler v. Mertens, No. 11-CV-03324-WJM-MJW, 2013 WL 607860 (D. Colo. Jan. 24, 2013) ..........................10 Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) .................................................................................................4 STATUTES 21 U.S.C. § 337(a) ...........................................................................................................................1 21 U.S.C. § 360k(a) .....................................................................................................................1, 2 OTHER AUTHORITIES Fed. R. Civ. P. 8(a) ..................................................................................................................1, 4, 6 Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 6 of 17 PageID #: 118 PRELIMINARY STATEMENT Defendant Smith & Nephew, Inc. (“Smith & Nephew”) submits this reply memorandum in further support of its Motion to Dismiss Plaintiffs’ Complaint, filed on November 11, 2016. As demonstrated in the Motion to Dismiss, Plaintiffs’ claims are expressly preempted by the Medical Device Amendments of 1976 (“MDA”) pursuant to 21 U.S.C. § 360k(a) and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Moreover, Plaintiffs’ claims based on Current Good Manufacturing Practices (CGMPs) arise solely from the alleged violation of federal requirements; therefore, they are impliedly preempted by federal law pursuant to 21 U.S.C. § 337(a) and Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 347-53 (2001). Plaintiffs rely heavily and pervasively throughout their Opposition on the Seventh Circuit Court of Appeals’ decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), as well as three Northern District of Illinois cases and a Southern District of West Virginia case decided under Bausch, in arguing that they have adequately pleaded “parallel” state common-law claims that survive express and implied preemption. Plaintiffs further argue that these cases somehow excuse Plaintiffs’ failure to comply with Rule 8(a) of the Federal Rules of Civil Procedure. Plaintiffs are incorrect. Plaintiffs’ reliance on Bausch and its progeny is misplaced. As shown below, Bausch required pleading of specific facts plausibly establishing a parallel claim. Moreover, to the extent the three Northern District of Illinois cases and the Southern District of West Virginia case (none of which are binding on this Court) departed from the Rule 8(a) standard and did not require factual specificity nor plausibility, those cases are wrongly decided. Those cases are also inconsistent with case law from the U.S. Supreme Court and the Third Circuit, which are binding on this Court, as well as case law from this Court. Therefore, Plaintiffs’ widespread reliance on these cases is misplaced and unpersuasive. Moreover, despite Plaintiffs’ repeated attempts in their Complaint and Opposition to Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 7 of 17 PageID #: 119 2 circumvent preemption with cursory suggestions that they are pursuing “parallel” state common- law claims, Plaintiffs fail to identify any “parallel” state-law requirement genuinely equivalent to the CGMPs they list as the bases for their claims. Because Plaintiffs pursue claims based on the theory that Smith & Nephew violated a slew of federal regulations, and because Plaintiffs have never identified any independent state-law basis for those claims, Plaintiffs have failed to plead an adequate parallel state-law claim. Therefore, Plaintiffs’ claims are preempted by federal law pursuant to Riegel and Buckman and should be dismissed with prejudice. Furthermore, Plaintiffs fail to plead facts in support of the basic elements of their claims. These pleading inadequacies further doom Plaintiffs’ Complaint pursuant to Iqbal and Twombly. Accordingly, this Court should dismiss the Complaint with prejudice. ARGUMENT I. PLAINTIFFS’ CLAIMS ARE PREEMPTED BY FEDERAL LAW As explained in the Motion (§ I-III), each of the claims in Plaintiffs’ Complaint is preempted by federal law. See Nagel v. Smith & Nephew, Inc., No. 3:15-cv-00927 (JAM), 2016 WL 4098715, at *4 (D. Conn. July 28, 2016) (describing the “daunting preemption hurdle for any state claims involving medical devices that have been subject to rigorous PMA approval”).1 Plaintiffs’ claims seek to impose requirements different from, or in addition to, federal law, and therefore are expressly preempted pursuant to 21 U.S.C. § 360k(a) and Riegel. 2 1 Plaintiffs incorrectly rely on a purported “presumption against preemption.” (See Opp. § II.A.) But such a presumption does not exist in cases, like this one, involving an express preemption provision. The U.S. Supreme Court recently clarified in Puerto Rico v. Franklin-California Tax- Free Trust, 136 S. Ct. 1938 (2016), that when a statute “contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.” Id. at 1946 (quotation marks and citation omitted). Because the instant case involves an express preemption clause-§ 360k(a)-the presumption against preemption does not apply. See id. 2 Plaintiffs incorrectly assert that some of the cases Smith & Nephew cited in its Motion involved devices cleared by the FDA pursuant to the less-stringent 510(k) standard. (Opp. at 8-9.) This is Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 8 of 17 PageID #: 120 3 Moreover, as established in the Motion (§ II), Plaintiffs’ claims based on alleged violations of CGMPs are impliedly preempted pursuant to Buckman. Buckman preemption turns on whether the existence of FDCA provisions or regulations “is a critical element in [a plaintiff’s] case.” Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1206 (9th Cir. 2002) (quoting Buckman, 531 U.S. at 353). As this Court has previously held, when alleged conduct “might violate the FDCA” but “would not exist apart from the FDCA,” such claims are preempted. Scanlon v. Medtronic Sofamor Danek U.S. Inc., 61 F. Supp. 3d 403, 412 (D. Del. 2014). Plaintiffs expressly acknowledge in their Complaint that their claims are “based on an exclusively federal statutory and regulatory set of requirements[.]” (Compl. ¶ 20 (emphasis added); see also Mot. at 9-10 and Opp. at 17-18 (citing additional allegations from the Complaint).) Because the federal CGMPs are the gravamen of Plaintiffs’ case, their claims would not exist apart from the FDCA, and Plaintiffs’ attempt to enforce those federal regulations is preempted.3 See Mink v. Smith & Nephew, Inc., 169 F. Supp. 3d 1321 (S.D. Fla. 2016). II. PLAINTIFFS HAVE FAILED TO PLEAD A “PARALLEL” CLAIM Courts applying the Riegel and Buckman Supreme Court preemption guideposts have flatly incorrect. The cases, like here, involved claims related to PMA-approved components. Additionally, Plaintiffs argue that some of the cases Smith & Nephew cited involved medical devices other than the BHR device at issue in this case. (See, e.g., id. at 8.) This has absolutely no relevance to the preemption analysis. What matters is that the device at issue, like the device in this case, was PMA-approved. (See Mot. at 7 (citing cases).) 3 Plaintiffs rely on Bausch to argue that Buckman does not apply to non-fraud on the FDA claims. This notion has been rejected, and courts apply Buckman to various claims beyond fraud on the FDA. See, e.g., Williams v. Zimmer US Inc., No. 5:14-cv-468-F, 2015 WL 4256249, at *7 (E.D.N.C. July 14, 2015) (“Buckman is not limited to fraud-on-the-FDA claims. . . . [I]t applies to any claims that depend entirely upon alleged FDCA violations . . . .”); DeBons v. Globus Med., Inc., No. 14-56455, 2016 WL 4363171, at *1 (9th Cir. Aug. 16, 2016) (negligence and failure to disclose information to consumers); Loreto v. Procter & Gamble Co., 515 F. App’x 576, 579 (6th Cir. 2013) (failure to disclose information to consumers); Richardson v. Bayer Healthcare Pharm. Inc., No. 4:15-CV-00443-BLW, 2016 WL 4546369, at *5 (D. Idaho Aug. 30, 2016) (design/manufacturing defect); Perdue v. Wyeth Pharm., Inc., No. 4:15-CV-208-FL, 2016 WL 3951091 (E.D.N.C. July 20, 2016) (failure to provide Medication Guide and off-label promotion). Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 9 of 17 PageID #: 121 4 explained that there is only a “‘narrow gap’ of permissible state claims” that can survive preemption as “parallel” to federal law. Pearsall v. Medtronics, Inc., 147 F. Supp. 3d 188, 194 (E.D.N.Y. 2015). “Plaintiffs cannot simply incant the magic words ‘[Defendants] violated FDA regulations’ in order to avoid preemption.” Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) (citation 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, 137 F. Supp. 3d at 199 (quotation marks and citation omitted). A. Bausch Is Distinguishable and Does Not Save Plaintiffs’ Claims Throughout their Opposition, Plaintiffs rely almost exclusively on Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) in arguing, inter alia, that (1) they have pleaded “parallel” claims that survive express and implied preemption and (2) those claims are adequately pleaded. But Bausch does not override Plaintiffs’ obligation to adequately plead specific facts in support of any “parallel” claim, as required by Rule 8(a), Iqbal, and Twombly. In Bausch, the plaintiff brought a single claim: that a component of a PMA-approved hip implant contained a manufacturing defect. Unlike Plaintiffs here, the Bausch plaintiff pleaded specific facts4 plausibly establishing a violation of both state and federal law that led to a manufacturing defect. Bausch, 630 F.3d at 559. The Seventh Circuit found that these allegations were sufficiently specific and plausible to support a parallel claim. Bausch, therefore, is distinguishable from the instant case, where Plaintiffs have pleaded no 4 These specific alleged facts include: 1) two years before plaintiff’s surgery, defendants received complaints that the component was failing post-implantation; 2) defendants recalled a batch of components due to “dimensional anomalies”; 3) after an FDA inspection of defendants’ manufacturing facilities, the FDA informed defendants of “numerous deficiencies” in the product’s “manufacturing and inspection processes”; 4) six days before plaintiff’s surgery, the FDA issued a warning letter finding that the components were “adulterated due to manufacturing methods . . . not in conformity with industry and regulatory standards”; 5) a device with the same catalog numbers as the devices subject to the warning letter was implanted in plaintiff; and 6) the device was ultimately recalled due to manufacturing problems. Bausch, 630 F.3d at 559. Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 10 of 17 PageID #: 122 5 specific facts whatsoever to support their claims. “Here, unlike [the plaintiffs in Bausch], Plaintiffs simply do not allege-or provide any factual support for an allegation of-violations of federal law . . . .” Aaron v. Medtronic, Inc., No. 1:13-CV-202, 2016 WL 5242957, at *4 (S.D. Ohio Sept. 22, 2016) (holding that such conclusory allegations would fail even under a standard less than that articulated in Iqbal/Twombly). Indeed, the court in Shuker v. Smith & Nephew PLC held that plaintiff’s allegations of violations of 21 C.F.R. § 820.80 - identical to Plaintiffs’ allegations here - were “incomprehensible” and insufficient to state a parallel claim. No. 1306158, 2015 WL 1475368, at *17 (E.D. Pa. Mar. 31, 2015). Simply put, “[t]o properly allege parallel claims, the complaint must set forth facts showing ‘action or inaction in [defendants’] efforts to take part in the PMA process or implement its results.’” Franklin v. Medtronic, Inc., No. 09-CV-02301REBKMT, 2010 WL 2543579, at *8 (D. Colo. May 12, 2010), report and rec. adopted, No. 09-CV-02301-REB-KMT, 2010 WL 2543570 (D. Colo. June 22, 2010) (quotations omitted). “Merely alleging that Defendant generally failed to comply with federal requirements is insufficient to overcome the preemptive reach of Section 360k(a) without some factual detail as to why Defendant violated federal regulations.” Id.; see also Babayev v. Medtronic, Inc., No. 10-cv-2038, 2017 WL 90403, at *20 (E.D.N.Y. Jan. 6, 2017) (plaintiff failed to state a parallel claim where “the pleading does not allege plausible facts that even suggest the nature of the defect or adulteration”). Here, Plaintiffs’ Complaint is wholly devoid of these requisite facts. The Complaint contains little more than hornbook allegations that fall far short of the specific and plausible allegations the Seventh Circuit found in Bausch. Accordingly, Plaintiffs have failed to adequately plead their claims that Smith & Nephew violated any state or federal requirements and, consequently, the Complaint must be dismissed. B. Plaintiffs Rely on Cases That Directly Contradict Binding Precedent Plaintiffs rely extensively on three Northern District of Illinois cases, and one Southern Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 11 of 17 PageID #: 123 6 District of West Virginia case, which held claims to be parallel. See Comella v. Smith & Nephew, Inc., No. 1:13-CV-01850, 2013 WL 6504427 (N.D. Ill. Dec. 11, 2013); Tillman v. Smith & Nephew, Inc., No. 1:12-CV-04977, 2013 WL 3776973 (N.D. Ill. July 18, 2013); Elmore v. Smith & Nephew, Inc., No. 1:12-CV-08347, 2013 WL 1707956 (N.D. Ill. Apr. 19, 2013); Raab v. Smith & Nephew, Inc., 150 F. Supp. 3d 671, 690-91 (S.D. W. Va. 2015). In each case, these non-binding decisions interpreted dicta in Bausch as dispensing with Rule 8(a) and Iqbal/Twombly’s requirement that a plaintiff must plead specific facts.5 See Comella, 2013 WL 6504427, at *3; Tillman, 2013 WL 3776973, at *4-5; Elmore, 2013 WL 1707956, at *5-6; Raab, 150 F. Supp. 3d at 690-91. These non-binding cases are incorrectly decided to the extent they 5 Notwithstanding the dicta in Bausch, a parade of other cases citing Bausch have not dispensed with Rule 8(a)’s specificity and plausibility requirements. See, e.g., Weaver v. Ethicon, Inc., No. 16CV257-GPC(BGS), 2016 WL 7098781, at *5 (S.D. Cal. Dec. 6, 2016) (finding plaintiff’s citation of Bausch “unavailing” and distinguishing Bausch because that plaintiff had “alleged facts that provided defendants with fair notice of the nature of the claims against them”); Corwin v. Connecticut Valley Arms, Inc., 74 F. Supp. 3d 883, 888-93 (N.D. Ill. 2014) (holding that even under Bausch, “[p]laintiff must plead facts that demonstrate” a breach of duty); Smith v. St. Jude Med. Cardiac Rhythm Mgmt. Div., Civ. No. CCB-12-1746, 2013 WL 1104427, at *4 (D. Md. Mar. 13, 2013) (stating “plaintiffs cannot simply incant the magic words ‘[Appellees] violated federal regulations’ in order to avoid preemption” and distinguishing Bausch because “the [Bausch] plaintiff did not simply rely on conclusory allegations of a failure to comply with the FDA requirements, but was able to cite to an FDA investigation into the approved device, an FDA product recall and a warning letter bearing a causal relationship to plaintiff’s alleged injuries” (quotation marks and citations omitted)); Anderson v. Boston Scientific Corp., No. 1:12- CV-00762, 2013 WL 632379, at *3, *4 n.1 (S.D. Ohio Feb. 20, 2013) (stating that plaintiff must provide factual support for an allegation of violation of federal law and that “[u]nfortunately for Plaintiffs, discovery cannot be used as a fishing expedition to uncover the facts necessary to support the causes of action presented in the complaint, even when the information needed to establish a claim . . . is solely within the purview of the defendant or a third party”) (quotation marks and citations omitted); Gross v. Stryker Corp., 858 F. Supp. 2d 466, 496 (W.D. Pa. 2012) (declining to follow pleading standard of Bausch as “in conflict with Twombly and Iqbal, as well as Third Circuit precedent”); White v. Stryker Corp., 818 F. Supp. 2d 1032, 1039-40 (W.D. Ky. 2011) (holding that failure to allege specific facts plausibly establishing non-compliance with FDA standard that led to product defect was insufficient even under the “lenient” Bausch standard); Desabio v. Howmedica Osteonics Corp., 817 F. Supp. 2d 197, 203-05 (W.D.N.Y. 2011) (distinguishing Bausch as involving a complaint with specific facts, and dismissing a complaint that consisted of “factually unsupported legal conclusions”). Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 12 of 17 PageID #: 124 7 fail to follow Rule 8(a) and Iqbal/Twombly,6 and are contrary to binding Third Circuit law, which requires specific facts establishing a plausible claim.7 See, e.g., Mann v. Brenner, 375 F. App’x 232, 235 (3d Cir. 2010); Boring v. Google, Inc., 362 F. App’x 273, 277-78 (3d Cir. 2010); see also Homax Products, Inc. v. Old Magic Corp., 61 F. Supp. 3d 413, 418 (D. Del. 2014) (quoting Phillips v. Cnty. of Allegheny, 515 F.3d 224, 234 (3d Cir. 2008)). C. Plaintiffs Identify No Parallel State-Law Duty Plaintiffs have failed to demonstrate that a “parallel” state-law duty exists independently of the federal requirements listed in their Complaint-i.e., that the failure to comply with CGMPs would violate state law “apart from the FDCA.” See Scanlon, 61 F. Supp. 3d at 412. (See Mot. III.A.) Indeed, Plaintiffs have not identified any duty (under either Delaware or Colorado law) that parallels the duties in the federal regulations. The titles of Plaintiffs’ counts are “Strict Products Liability” and “Negligence” followed by a string of federal CGMPs. (Compl. Count 1, 2.) Under those titles, Plaintiffs paste a laundry list of federal CGMPs (Compl. ¶¶ 17, 25) - a mere carbon copy of a list of CGMP violations pulled from several other complaints, filed in other jurisdictions, involving the BHR System8 - but fail to mention any state-law duty. Their Opposition similarly fails to identify a single state authority (Delaware, 6 Notably, all three Illinois cases were subsequently voluntarily dismissed by plaintiffs after discovery failed to reveal any viable parallel claims. Voluntary Dismissal Order, Tillman v. Smith & Nephew, Inc., No. 1:12-cv-04977 (N.D. Ill. June 2, 2014), ECF No. 52; Voluntary Dismissal Order, Elmore v. Smith & Nephew, Inc., No. 1:12-cv-08347 (N.D. Ill. Mar. 26, 2014), ECF No. 64; Notification of Docket Entry, Comella v. Smith & Nephew, Inc., No. 1:13-cv-01850 (N.D. Ill. Mar. 19, 2014), ECF No. 58. 7 To the extent Plaintiffs argue that the Court should apply Colorado law, Colorado federal courts, too, hold that conclusory allegations do not satisfy Rule 8. See, e.g., Franklin, 2010 WL 2543579, at *8; Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 1301-02 (D. Colo. 2008). 8 See, e.g., Complaint and Demand for Jury Trial, Spellman v. Smith & Nephew, Inc., No. 3:16- cv-08080-DKD (D. Ariz. Apr. 28, 2016), ECF No. 1; Amended Complaint, Raab v. Smith & Nephew, Inc., No. 2:14-cv-30279 (S.D. W. Va. Apr. 20, 2015), ECF No. 21; Amended Complaint at Law, Tillman v. Smith & Nephew, Inc., No. 1:12-cv-04977, 2012 WL 11660220 (N.D. Ill. Nov. 12, 2012); Complaint, Elmore v. Smith & Nephew, Inc., No. 1:12-cv-08347, 2012 WL 5354495 (N.D. Ill. Oct. 17, 2012). Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 13 of 17 PageID #: 125 8 Colorado, or otherwise) discussing any such parallel duty. Indeed, it states: “the allegations here are quite narrowly tailored and specific to 21 C.F.R. 820, et seq. violations. The allegations do not impose traditional or ‘generic’ state law theories of liability.” (Opp. at 7.) Simply put, “[t]o state a parallel claim, a plaintiff must show that the state requirement was ‘genuinely equivalent’ to the federal requirement.” Grubbs v. Synthes, No. 8:15-cv-00443- T-27TGW, 2016 WL 360610, at *3 (M.D. Fla. Jan. 19, 2016) (quoting Wolicki-Gables, 634 F.3d at 1300). But Plaintiffs fail to identify any state law, let alone one that is parallel-or “genuinely equivalent”-to the federal regulations. 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 1334 (quotations omitted). Rather, as explained in the Motion, they must show a state-law duty that exists independently of federal requirements-i.e., that the failure to comply with the list of CGMPs in their Complaint would violate state law “even if the FDCA had never been enacted.”9 Norman v. Bayer Corp., No. 3:16-cv-00253, 2016 WL 4007547, at *4 (D. Conn. July 26, 2016) (emphasis added) (quotation marks and citation omitted). They have failed to do so. See, e.g., Ellis v. Smith & Nephew, Inc., No. 6:15-cv-545-TMC (D.S.C. Feb. 16, 2016), Doc. 52 (Ex. A) (addressing a nearly-identical list of CGMPs and holding that “Plaintiff has failed to allege how the violations of these federal requirements would give rise to liability under state law”). Accordingly, Plaintiffs have not stated a parallel claim that survives preemption. D. CGMP Violations Cannot Serve As the Basis for “Parallel” Claims As explained at length in the Motion, the broad CGMP requirements that underscore Plaintiffs’ claims do not render those claims “parallel” to federal law. (Mot. § III.B.) As many 9 Plaintiffs assert that under this analysis, there could never be a parallel claim. That is false. For example, the court in Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d. 582, 589 (E.D.N.Y. 2009) noted two cases in which plaintiffs properly pleaded a parallel claim under this standard: Purcel v. Advanced Bionics Corp., No. 3:07-CV-1777-M, 2008 WL 3874713 (N.D. Tex. Aug. 13, 2008) and Rollins v. St. Jude Medical, 583 F. Supp. 2d 790 (W.D. La. 2008). Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 14 of 17 PageID #: 126 9 courts have held, these broad manufacturing requirements, not specific to the medical device at issue, cannot serve as a parallel claim because of their “intentionally vague and open-ended nature.” Ilarraza, 677 F. Supp. 2d. at 588. Allowing claims based on these broad CGMPs would lead different courts to establish different safety requirements, which is exactly the problem that §360k(a) seeks to preclude. See id.; see also Horn v. Boston Sci. Neuro. Corp., No, CV-409-074, 2011 WL 3893812, at *9 (S.D. Ga. Aug. 26, 2011) (holding that broad federal regulations “fail to provide any tangible or concrete standard” and therefore cannot serve as the basis for a parallel claim); see also Mot. at 12-13 (citing cases). III. PLAINTIFFS HAVE FAILED TO ADEQUATELY PLEAD THEIR COUNTS Plaintiffs’ Complaint is completely devoid of the factual support required by Rule 8(a) and binding Supreme Court precedent. Plaintiffs appear to misunderstand the federal pleading standard and what it means to plead facts in support of each element of a cause of action, pursuant to Twombly and Iqbal. They never explain in their Opposition how their boilerplate allegations lacking any factual support could survive dismissal. Instead, they curiously attempt to circumvent their pleading requirements with the empty statement that pleading factual support is “not Plaintiff’s obligation under Rule 12(b)(6) or 8(a).” (Opp. at 20.) Yet pleading adequate factual support is precisely Plaintiffs’ obligation under those rules. (See Mot. at 11-13 (articulating the federal pleading standard pursuant to Twombly and Iqbal).)10 Nor can Plaintiffs escape their obligation simply by arguing that Colorado law, rather than 10 See also, e.g., In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1207 (8th Cir. 2010); Aaron, 2016 WL 5242957, at *4; Bertini v. Smith & Nephew, Inc., No. 13 CIV. 0079(BMC), 2013 WL 6332684, at *4 (E.D.N.Y. July 15, 2013); see Ali v. Allergan USA, Inc., No. 1:12-cv-115 (GBL/TRJ), 2012 WL 3692396, at *14 (E.D. Va. Aug. 23, 2012) (“This is precisely the sort of fishing expedition the Supreme Court sought to avoid in requiring the plaintiff to plead facts demonstrating their entitlement to relief and the defendant’s liability for misconduct. . . . Plaintiffs cannot be permitted to pursue ‘extensive discovery’ with nothing more than a series of conclusory allegations and an unfounded hope that the process will yield favorable facts.”). Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 15 of 17 PageID #: 127 10 Delaware law, should be applied to their claims. Plaintiffs have pleaded neither the specific purported defect in the BHR system, the source of any such defect, nor how any purported defect caused their injuries. Accordingly, regardless of which state’s law applies, Plaintiffs have failed to meet the federal pleading standard.11 Pursuant to binding Supreme Court precedent, this Court should dismiss Plaintiffs’ bare-bones claims as inadequately pleaded. (See Mot. at 19.) CONCLUSION For the foregoing reasons, and those discussed in the Motion, Smith & Nephew respectfully requests that the Court enter an order granting Smith & Nephew’s Motion to Dismiss and dismissing Plaintiffs’ Complaint in its entirety with prejudice. Dated: February 3, 2017 Respectfully submitted, By: /s/ John C. Cordrey John C. Cordrey (No. 5324) 11 The Motion explains why Plaintiffs’ claims fail under Delaware law, but Plaintiffs likewise fail to plead sufficient facts in support of the elements required to establish their purported claims under Colorado law. Under Colorado law, both strict liability claims and negligence claims require that the plaintiff establish a product defect. See Haffner v. Stryker Corp., No. 14- CV-00186-RBJ, 2014 WL 4821107, at *2 (D. Colo. Sept. 29, 2014) (the elements of a strict liability - design defect claim are “(1) the product is in a defective condition unreasonably dangerous to the user or consumer; (2) the product is expected to and does reach the consumer without substantial change in the condition in which it is sold; (3) the design defect caused the plaintiff’s injury; (4) the defendant sold the product and is engaged in the business of selling products; and (5) the plaintiff sustained damages.” (quotations omitted)); Winkler v. Mertens, No. 11-CV-03324-WJM-MJW, 2013 WL 607860, at *4 (D. Colo. Jan. 24, 2013) (the elements of a strict liability - manufacturing defect claim include: “the product was defective and, because of the defect, was unreasonably dangerous to a person who might reasonably be expected to use it; the product was defective at the time the manufacturer sold it; the product was expected to, and did, reach the user without substantial change; plaintiff was a person reasonably expected to use the product, was injured, and the product’s defect caused plaintiff’s injuries.” (quotation marks and citation omitted)), report and rec. adopted, No. 11-CV-03324-WJM-MJW, 2013 WL 607857 (D. Colo. Feb. 19, 2013); Haffner, 2014 WL 4821107, at *5 (in an action for negligence, a plaintiff must allege that: (1) the defendant owed a legal duty of care to the plaintiff; (2) the defendant breached that duty; (3) the plaintiff suffered injury; and (4) the defendant’s breach of his duty caused plaintiff’s injury). Plaintiffs’ Complaint lacks the requisite factual support for each of the required elements of their claims under Colorado law. Accordingly, even if Colorado law applies, Plaintiffs’ claims must be dismissed as inadequately pleaded. Case 1:16-cv-00712-LPS Document 11 Filed 02/03/17 Page 16 of 17 PageID #: 128 11 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 11 Filed 02/03/17 Page 17 of 17 PageID #: 129 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 REPLY MEMORANDUM OF LAW IN FURTHER SUPPORT OF ITS 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 Reply Memorandum of Law in Further Support of Its Motion to Dismiss Plaintiffs’ Complaint. 2. Attached hereto as Exhibit A is a true and correct copy of the unreported opinion, Ellis v. Smith & Nephew, Inc., No. 6:15-cv-545-TMC (D.S.C. Feb. 16, 2016), ECF No. 52. I hereby declare under penalty of perjury that the foregoing is true and correct. Dated: February 3, 2017 /s/ Glenn S. Kerner Glenn S. Kerner Case 1:16-cv-00712-LPS Document 11-1 Filed 02/03/17 Page 1 of 1 PageID #: 130 EXHIBIT A Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 1 of 16 PageID #: 131 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF SOUTH CAROLINA GREENVILLE DIVISION David Ellis, ) ) C/A No. 6:15-545-TMC Plaintiff, ) ) v. ) ORDER ) ) Smith & Nephew, Inc., ) ) Defendant. ) _________________________________ ) Plaintiff David Ellis (“Plaintiff”) filed this action against Defendant Smith & Nephew, Incorporated, (“Smith & Nephew”) alleging several claims arising from a hip replacement. This matter is before the court on Smith & Nephew’s motion to dismiss. (ECF No. 29). Plaintiff filed a response opposing the motion (ECF No. 30) and Smith & Nephew filed a reply (ECF No. 34). Additionally, with leave of the court, the parties submitted supplemental briefs on the motion (ECF Nos. 38 and 39). The court held a hearing on the motion and took the matter under advisement. I. Facts/Background In his Second Amended Complaint, Plaintiff alleges that he underwent hip replacement surgery on July 27, 2009, and had complications which eventually required revision surgery on December 2, 2013. (2nd Am. Compl. ¶¶ 25, 28, 29, ECF No. 24 ¶¶ 25, 28, 29).1 Following the original surgery, Plaintiff experienced progressive hip pain, mechanical problems causing him to be unable to walk without assistance, and cobalt poisoning. (Id. at ¶¶ 28, 30). After the revision 1The court notes that in response to a previously filed motion to dismiss filed by Smith & Nephew (ECF No. 6), Plaintiff has amended his Complaint twice. (ECF Nos. 15 and 24). 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 1 of 15 A1 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 2 of 16 PageID #: 132 surgery, Plaintiff alleges he still continues to suffer the effects. (Id. at ¶ 29). The product used in Plaintiff’s original hip replacement, the Birmingham Hip Resurfacing (“BHR”) System, was manufactured by Smith & Nephew. (Id. at 25). The BHR System is a Metal-on-Metal Hip Implant Product. Id. Plaintiff alleges state law claims for negligence, strict products liability, breach of express and implied warranties, negligent misrepresentation, misrepresentation by omission, and violations of SCUTPA. In its motion to dismiss, Smith & Nephew contends that all of Plaintiff’s claims are preempted by the Medical Device Amendments of 1976 (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360c, because the BHR is a Class III medical device and which was approved through the FDA’s pre-market approval (“PMA”) process. It also contends that Plaintiff has failed to plead a parallel claim with the specificity and plausibility required by Fed.R.Civ.P. 8. Plaintiff contends that his claims are not preempted and that he has pled parallel claims with sufficient specificity and plausibility to satisfy Rule 8. Plaintiff also argues that dismissal is not proper because he has not been afforded an opportunity to conduct discovery. II. Applicable Law A motion to dismiss pursuant to Rule 12(b)(6) for failure to state a claim upon which relief can be granted “challenges the legal sufficiency of a complaint.” Francis v. Giacomelli, 588 F.3d 186, 192 (4th Cir. 2009) (citations omitted). To be legally sufficient a pleading must contain a “short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). A Rule 12(b)(6) motion should not be granted unless it appears certain that the plaintiff can prove no set of facts that would support her claim and would entitle her to relief. Mylan 2 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 2 of 15 A2 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 3 of 16 PageID #: 133 Labs., Inc. v. Matkari, 7 F.3d 1130, 1134 (4th Cir. 1993). When considering a motion to dismiss, the court should accept as true all well-pleaded allegations and should view the complaint in a light most favorable to the plaintiff. Ostrzenski v. Seigel, 177 F.3d 245, 251 (4th Cir. 1999); Mylan Labs., Inc., 7 F.3d at 1134. “To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007)). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. III. Discussion Medical devices are classified into three categories under the Medical Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 360c. Medical devices that present no unreasonable risk of illness or injury are designated as Class I devices and are subject to only minimal regulation. 21 U.S.C. § 360c(a)(1)(A). Medical devices that are potentially more harmful are designated as Class II devices, and must comply with federal performance regulations, referred to as “special controls.” 21 U.S.C. § 360c(a)(1)(B). Medical devices that either “presen[t] a potential unreasonable risk of illness or injury,” or which are “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” are designated as Class III devices. 21 U.S.C. § 360c(a)(1)(C). A Class III device, such as the BHR, must undergo a rigorous premarket approval process, and be granted premarket approval (“PMA”) by the FDA. Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008). In determining whether a device should be granted approval, the FDA 3 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 3 of 15 A3 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 4 of 16 PageID #: 134 must weigh “any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” 21 U.S.C. § 360c(a)(2)(C). The PMA process is rigorous, and it begins with the manufacturer of the medical device submitting detailed information to the FDA regarding the safety and efficacy of the device. Riegel, 552 U.S. at 317. The FDA spends an average of 1,200 hours reviewing the submitted information and “grants [PMA] only if it finds there is a ‘reasonable assurance’ of the device's ‘safety and effectiveness.’ ” Id. After a device receives PMA, federal law forbids the manufacturer from making “changes in design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness” without FDA approval. Id. A manufacturer is also required to “report to the FDA when an approved device may have caused or contributed to a death or serious injury or malfunctioned in a way that would make it likely to do so in the future,” and “periodically inform the FDA about data from clinical studies or scientific literature related to the device.” Walker v. Medtronic, Inc., 670 F.3d 569, 574 (4th Cir. 2012) (internal citations and quotation marks omitted). Additionally, the FDCA includes an implicit preemption provision requiring that any action “for the enforcement, or to restrain violations” of the FDCA be brought “by and in the name of the United States.” 21 U.S.C. § 337(a). While private individuals “may report wrongdoing and petition the agency to take action,” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 (2001) (citing 21 C.F.R. § 10.30), Congress had made clear that there is no private right of action under the FDCA and all actions to enforce the statute “shall be by and in the name of the United States.” Id. at 349 n.4 (quoting 21 U.S.C. § 337(a)). Thus, the FDA retains exclusive enforcement authority over the manufacturers pursuant to the FDCA. The FDA’s exclusive enforcement right is reiterated by the MDA’s express preemption clause, providing that no state may impose “any requirement” relating to the safety or 4 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 4 of 15 A4 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 5 of 16 PageID #: 135 effectiveness of a medical device that is “different from, or in addition to, any requirement applicable . . . to the device” under federal law. 21 U.S.C. § 360k(a). This clause bars state law tort claims against Class III device manufacturers premised on different or additional requirements for purposes of § 360k(a), and thus such claims are preempted. See Riegel, 552 U.S. at 322-25. See also Walker , 670 F.3d at 577. Considered together, §§ 337(a) and 360k(a) preempt “nearly all types of claims concerning FDA-approved medical devices.” In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 592 F.Supp.2d 1147, 1161 (D.Minn. 2009). However, there is one narrow exception to this rule. Plaintiffs may bring claims directly against the device manufacturers if their state law claims parallel federal law, i.e., do not impose requirements that are different from, or in addition to, those already imposed on the manufacturers by federal law. Riegal, 552 U.S. at 330. District courts in the Fourth Circuit have unanimously held that a well-pleaded parallel state law claim “must at least (1) identify the federal requirement applicable to the device with which it allegedly failed to comply and (2) explain how that violation of a federal requirement caused the plaintiff’s injury.” See Wells v. Allergan USA, Inc., C/A No. 6:12-cv- 3509, 2014 WL 117773 *2 (D.S.C. Jan. 13, 2014)(citing cases). “To properly allege parallel claims, the complaint must set forth facts pointing to specific PMA requirements that have been violated.” Gelber v. Styker Corp., 788 F.Supp.2d 145, 155 (S.D.N.Y. 2011). Although it may be difficult for plaintiffs to identify “the precise defect or the specific federal regulatory requirements that were allegedly violated . . . because certain premarket approval documents are confidential,” plaintiffs must still meet the pleading standards set forth in Twombly and Iqbal. Id. at 157 (citation omitted). “To complicate the preemption doctrine further, however, a plaintiff's claim cannot be based solely on [a violation of federal law]” Franzese v. St. Jude Med., Inc., No. 13-CV-3203 (JS)(WDW), 2014 WL 2863087, at *3 5 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 5 of 15 A5 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 6 of 16 PageID #: 136 (E.D.N.Y. June 23, 2014), because, as noted above, there is no private cause of action for noncompliance with the medical device provisions of the FDCA. See Buckman Co., 531 U.S. 341, 349 n. 4. Thus, there is “a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption.” In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010)). On the one hand, the plaintiff's claim must be based on conduct that violates federal law (i.e., a parallel claim), or else it is preempted, but ‘the plaintiff must not be suing because the conduct violates federal law, because he has no private right to bring such a claim.” Id. The parallel claim, however, must arise from an actual state-law requirement; it cannot exist “solely by virtue of the FDCA . . . requirements.” Buckman,, 531 U.S. at 352-53. (holding that claims that such claims are impliedly preempted). “For a state-law claim to survive, then, the claim 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.” Williams v. Smith & Nephew, Inc., C/A No. CCB-14-3138, 2015 WL 4984531 *10 (D. Md. Aug. 18, 2015) (internal citation omitted). Further, a plaintiff must “set forth facts pointing to specific premarket approval requirements that have been violated, and link those violations to his injuries.” Buckman, 531 U.S at 352-53. The parties agree that the BHR is a Class III medical device subject to preemption. However, they disagree as to whether Plaintiff’s claims are preempted and whether Plaintiff has properly alleged any parallel state claims with the requisite specificity. Plaintiff acknowledges that “[t]o avoid preemption, [he] must ‘make some showing that the medical device was not manufactured in accordance with FDA standards.” (ECF No. 30 at 8; ECF No. 38 at 10) (internal citation and quotation marks omitted). Plaintiff relies heavily on Medtronics v. Lohr, 518 U.S. 470 (1996). (ECF No. 30 at 8-10, 13-14; ECF No. 38 at 10-12, 16-17). He contends 6 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 6 of 15 A6 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 7 of 16 PageID #: 137 that because general state common law requirements of negligence, product liability, breaches of warranty, and misrepresentation were not specifically developed with respect to medical devices, they are not the kind of requirements that §360k meant to preempt. (ECF No. 30 at 9; ECF No. 38 at 12). Further, Plaintiff argues that the BHR failed to accomplish its intended purpose, the purpose that was approved by the FDA, which caused serious injuries to the Plaintiff. The product that was actually implanted into the Plaintiff in this case was defective (i.e. a condition not conforming to what was approved), which caused the Plaintiff to suffer injuries. (ECF No. 30 at 2; ECF No. 38 at 3-4). Plaintiff argues that if the product was not defective, it would not have caused Plaintiff’s injuries and that “[t]his basic premise is that basis from which all of Plaintiff’s allegations flow.” (ECF No. 30 at 2).2 The court finds that Lohr is not on point with this case. The device in Lohr did not receive PMA approval, but instead received FDCA’s approval through the much less rigorous §510(k) process. Lohr, 518 U.S. 470, 478-79 (explaining that the §510(k) process is an 2In his Second Amended Complaint, Plaintiff alleges that there was a market recall of the acetabular component on or about June 1, 2012. (2nd Am. Compl. ¶ 27). Smith & Nephew notes that the recall was for a different device, and not the one that was implanted into Plaintiff. (ECF No. 29-1 at 3 n.3). In his supplemental memorandum, Plaintiff argues that the device involved in this action was recalled in June 2015 after Smith & Nephew finally recognized the overwhelming number of revisions needed in patients using certain size femoral heads. (ECF No. 38 at 1-2, 4). Plaintiff appears to allege that the recall defeats any preemption argument because the recall establishes that the BHR was defective and did not conform to what the FDA approved. Id. at 10. In June 2015, Smith and Nephew voluntarily removed certain components of the BHR from the market - specifically femoral heads 46mm diameter and smaller and the corresponding acetabular cup. In reality, this was a contraindication of the BHR in all female patients and in males requiring a femoral head less than 46mm in future surgeries. (ECF No. 38- 1 and 2). Even if Smith & Nephew had recalled the device, a recall does not, as a matter of law, undermine the preemptive effect of the BHR's PMA. See In Re Medtronic Inc. Sprint Fidelis Leads Prod. Liab. Litis., 592 F.Supp.2d 1147, 1155, affirmed, 623 F.3d 1200 (8th Cir. 2010) (rejecting such an argument); see also Simmons v. Boston Scientific Corp., No. CV 12-7962 PA FFMX, 2013 WL 1207421, at *4 (C.D.Cal. Mar. 25, 2013) (“[C]ourts have recognized that product recalls do not create a presumption that FDA requirements have been violated.” (citing cases)). 7 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 7 of 15 A7 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 8 of 16 PageID #: 138 “exemption from federal safety review”). See also Riegel, 552 U.S. at 323 (“While § 510(k) is focused on equivalence, not safety, premarket approval is focused on safety, not equivalence.”) (internal quotation omitted). Moreover, while devices approved under § 510(k) are subject only to general federal regulations “applicable across the board to almost all medical devices,” the FDA requires the devices which undergo PMA “to be made with almost no deviations from the specifications in its approval application. See id. at 322-23. The court addresses each of Plaintiffs’ claims raised in Plaintiffs’ Second Amended Complaint to determine whether they are preempted or fail to state a claim. Count One (Negligence) and Count Two (Strict Products Liability) In Count One, Plaintiff alleges Smith & Nephew was negligent and breached its duty of reasonable care by “designing, manufacturing, assembling, inspecting, testing, marketing, distributing, and selling Metal-on-Metal Hip Implant Products in a defective and unreasonably safe condition, including but not limited to, its propensity for metal-on-metal failure.” (2nd Am. Compl. ¶ 33). Plaintiff alleges that the BHR implanted in Plaintiff “differed in design, manufacture, packaging, storing, warning, labeling, distribution and advertising from the BHR device that received PMA . . .” (2nd Am. Compl. ¶ 35). Then, Plaintiff alleges that the BHR deviated from the PMA and/or violated federal regulations in twelve specific ways: a. Failed to accurately establish the in vivo life expectancy of the BHR, in violation of 21 C.F.R. 820.30(g); b. Failed to validate the anticipated wear of the femoral head prior to being released into commercial distribution, in violation of 21 C.F.R. 820.30 (g); c. Failed to establish and maintain appropriate reliability assurance testing to validate the BHR design before and after its release into the marketplace, in violation of 21 C.F.R. 820.30 (g); d. Failed to identify and correct the component discrepancy of the difference in hardness in metal of the femoral head which allowed for breakdown significantly sooner than the approved component, in violation of 21 C.F.R. 820.80(c); 8 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 8 of 15 A8 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 9 of 16 PageID #: 139 e. Failed to capture the component discrepancy or defect during its Acceptance Activities, in deviation of the PMA and in violation of 21 C.F.R. 820.80(d); f. Failed to establish and maintain procedures for implementing corrective and preventative action in response to complaints regarding the BHR and/or other quality problems associated with the BHR, in violation of 21 C.F.R. 820.100; g. Failed to accurately label the carton containing the acetabular cup, by placing a different, inaccurate label than that required by the PMA, in violation of 21 C.F.R. 820.120; h. Released the mislabeled product into the stream of commerce, post PMA and in deviation of the PMA and in violation of 21 C.F.R. 820.120; I. Failed to appropriately respond to adverse incident reports post PMA that indicated the BHR was malfunctioning, or otherwise not responding to its Design Objective Intent, in violation of 21 C.F.R. 820.198; j. Failed to conduct complete device investigations on returned BHR and components post PMA, in violation of 21 C.F.R. 820.198; k. Continued to inject BHR systems into the stream of interstate commerce post PMA when it knew, or should have known, that the BHR system was malfunctioning or otherwise not responding to its Design Objective Intent; and l. Violated a duty to warn the FDA and doctors post PMA about the dangers that became known to the Defendant after the product was put on the market, including the fact that highly elevated cobalt levels were causing tissue irritation, damage to muscle and bone, loosening of the implant, metal toxicity, blood poisoning, and/or cardiomyopathy in patients implanted with this device. (2nd Am. Compl. ¶ 37).3 However, Plaintiff has failed to allege how the violations of these federal requirements would give rise to liability under state law for his injuries. Riley v. Cordis Corp., 625 F.Supp.2d 769, 77677 (D. Minn. 2009) (internal citations omitted). See also Franklin v. Medtronic, Inc., 2010 WL 2543579, at *10 (D.Colo. May 12, 2010) (“[Merely alleging some violation of FDA regulation will not suffice to establish a ‘parallel’ claim, unless Plaintiff can factually demonstrate that the violation actually caused her injuries.”). In Count Two, Plaintiff alleges a claim of strict products liability. (2nd Am. Compl. ¶¶ 42- 46). Specifically, Plaintiff alleges that he bases this claim on the contention that Smith & 3The FDA has mandated “current good manufacturing practices,” or CGMP, which are outlined in 21 C.F.R. § 820.30. 9 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 9 of 15 A9 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 10 of 16 PageID #: 140 Nephew “deviated from the requirements of the FDA/PMA and violated post PMA statutory and regulatory requirements, thus violating federal safety statutes and regulations.” (2nd Am. Compl. ¶ 44). Plaintiff avers that he is “only alleging state common law claims parallel with federal law requirements.” Id. In Riegel, the United States Supreme Court citing Lohr, held that it adhered to the view that “common-law causes of action for negligence and strict liability do impose [different or additional] requirements and would be pre-empted by federal requirements specific to a medical device.” Riegel, 128 U.S. at 323-24. The Court reasoned 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. (internal quotations and citations omitted). Moreover, Plaintiff alleges no facts to identify the particular PMA requirements that were violated or how any such violations are linked to their alleged injuries. Accordingly, the court finds these claims are preempted. Count Three ( Breach of Express Warranty) In Count Three, Plaintiff alleges a claim for breach of an express warranty. (2nd Am. Compl. ¶¶ 47-52). Specifically, Plaintiff alleges that the PMA informed Smith & Nephew that the FDA did not evaluate information related to contract liability warranties, but that “warranty statements must be truthful, accurate, and not misleading, and must be consistent with applicable Federal and State laws.” (2nd Am. Compl. ¶ 48). Plaintiff alleges that Smith & Nephew “warranted through its marketing, advertising, distributors and sales representatives that the Metal-on-Metal Hip Implant Products were of merchantable quality, fit for ordinary purposes and uses for which they were sold . . .” Id. at ¶ 49. Further, Plaintiff alleges that Smith & 10 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 10 of 15 A10 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 11 of 16 PageID #: 141 Nephew “is aware that health care providers and patients, including the Plaintiff, rely upon the representations made by the Defendant when choosing, selecting, and purchasing its products, including the Metal-on-Metal Hip Implants Products.” Id. at 50. Under South Carolina law, an express warranty is created in the following ways: (a) Any affirmation of fact or promise, including those on containers or labels, made by the seller to the buyer, whether directly or indirectly, which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods conform to the affirmation or promise. (b) Any description of the goods which is made part of the basis of the bargain creates an express warranty that the goods shall conform to the description. (c) Any sample or model which is made part of the basis of the bargain creates an express warranty that the whole of the goods shall conform to the sample or model. S.C. Code § 36-2-313(1). “When goods do not conform to a promise or an affirmation of fact made by a seller, or the goods do not conform to a description, sample, or model, then a seller has breached an express warranty.” Herring v. Home Depot, Inc., 565 S.E.2d 773, 776 (S.C.Ct.App. 2002) (internal quotation marks omitted). If Plaintiff’s breach of express warranty claim is premised on statements made in an FDA-mandated document, such a claim is preempted. A finding that a defendant violated state law by not living up to FDA-approved promises would necessarily conflict with the FDA's determination that the label was not false or misleading. To hold Smith & Nephew liable “for making the statements that the FDA required it to make, or . . . for not making statements that the FDA required it not to make,” would be to impose state law requirements “different from, or in addition to,” federal ones. See Riley v. Cordis Corp., 625 F.Supp.2d 769, 787 (D. Minn. 2009) (holding that “express-warranty claims that are based solely on the contents of an FDA-approved label are expressly preempted by § 360k(a).”). Moreover, if Plaintiff’s breach of express warranty claim is based on non-FDA-approved representations, although such a claim 11 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 11 of 15 A11 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 12 of 16 PageID #: 142 could survive preemption, it would still ultimately fail here because, Plaintiff does not set forth the content of any express warranty nor identify the source of the express warranty (i.e., whether it was made in a publication, package insert, or advertising). Further, Plaintiff does not allege how it became the basis of a bargain between Plaintiff and Smith & Nephew. Here, based on the foregoing, Plaintiff’s breach of express warranty must be dismissed. Count Four (Breach of Implied Warranty) In Count Four, Plaintiff alleges that Smith & Nephew violated implied warranties of merchantability because the BHR was not merchantable nor suited for its intended purposes. (2nd Am. Compl. ¶¶ 54-59). However, the FDA, through the PMA process, expressly defines the scope of a device's “intended use,” 21 U.S.C. § 360e(c)(2)(A)(iv), and determines all representations Smith & Nephew “is obligated to make concerning” the BHR System. See Schouest v. Medtronic, Inc., 13 F.Supp.3d 692, 707 (S.D.Tex. 2014). Accordingly, Plaintiff’s claim for breach of an implied warranty relies on requirements imposed by state law that are more burdensome than those imposed by the MDA, and thus such a claim is expressly preempted. See Hesik v. Boston Scientific Corp., C/A No. 1:12-cv-00014-JMC, 2014 WL 5644699, *8 (D.S.C. Nov. 4, 2014) (finding plaintiff's implied warranties claim expressly preempted by the MDA). Count Five (Negligent Misrepresentation) and Count Six (Misrepresentation by Omission) In Counts Five and Six, Plaintiff basically alleges a failure to warn the FDA, the Plaintiff, and the medical community” of adverse reactions. (2nd Am. Compl. at ¶¶ 61, 64, 71, and 72). The federal requirements require that adverse events and other reports be made to the FDA. Consequently, a common law duty to provide a warning to the public and medical community 12 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 12 of 15 A12 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 13 of 16 PageID #: 143 imposes a requirement additional to the federal regulations and is preempted.” Cormella v. Smith & Nephew, 2013 WL 6504427 (N.D. Ill. Dec. 11, 2013). See also Cupek v. Medtronics, 405 F.3d 421 (6th Cir. 2005) (holding that any state law claim alleging failure to warn patients beyond warnings required by the FDA constitutes different or additional requirements under the PMA and thus not parallel); Bertini v. Smith & Nephew, Inc., 8 F.Supp.3d 246, 256 (E.D.N.Y. 2014) (finding plaintiff's failure to warn claim is preempted by the MDA where plaintiff is unable to show state and federal requirements are parallel). Therefore, to the extent that the complaint alleges a breach of a duty to advise or warn the public and medical community, it creates an additional requirement and is preempted. Additionally, the court finds that since Plaintiff’s remaining failure to warn claim is predicated on Smith & Nephew’s alleged failure to provide required reports to the FDA, authority to enforce that claim rests with the FDA. See 21 U.S.C. § 337(a); Sprint Fidelis Leads Litig. I, 592 F.Supp.2d at 1160-1161. Such a claim would simply be an attempt by private parties to enforce the MDA. Buckman, 531 U.S. at 349, 353. Accordingly, these claims are preempted. Count Seven -(SCUTPA violations) In Count Seven, Plaintiff alleges a violation of the SCUTPA. (2nd Am. Compl. ¶¶ 78- 83). Specifically, Plaintiff alleges Smith & Nephew engaged in deceptive acts - particularly by failing to inform the FDA, Plaintiff, and other purchasers of failures and adverse reactions. Id. at ¶¶ 80-81. To recover in an action under the SCUTPA, Plaintiff “must show: (1) the defendant engaged in an unfair or deceptive act in the conduct of trade or commerce; (2) the unfair or deceptive act affected the public interest; and (3) the plaintiff suffered monetary or property loss 13 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 13 of 15 A13 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 14 of 16 PageID #: 144 as a result of the defendant's unfair or deceptive act(s).” Health Promotion Specialists, L.L.C. v. S.C. Bd. of Dentistry, 743 S.E.2d 808, 816 (S.C. 2013) (citation omitted). Plaintiff is essentially asserting a failure to warn claim that is preempted for the reasons discussed above. This claim is not a parallel claim as it requires different or additional requirements than what the FDA requires. See Riegel, 552 U.S. at 322-25. Accordingly, this claim is preempted. Plaintiff also contends that he should be allowed to conduct discovery to discover essential information. (ECF No. 30 at 15-16; ECF No. 38 at 17-18). Specifically, Plaintiff seeks to locate the explanted BHR so that it may be investigated for additional deformities. (ECF No. 30 at 16; ECF No. 38 at 18). Smith &Nephew contends that Plaintiff is not entitled to discovery to investigate their claims. (ECF No. 34 at 7-9; ECF No. 39 at 4-5). Because preemption may often be determined from the face of the complaint, “many PMA preemption motions are decided without any discovery.” Smith v. Depuy Orthopaedics Inc., 552 Fed.Appx. 192, 196 (3d Cir. 2014) (citing Bass v. Stryker Corp., 669 F.3d 501, 508 n. 1 (5th Cir. 2012); Gross v. Stryker, Corp., 858 F.Supp.2d 466, 505 (W.D.Pa. 2012); Lewkut v. Stryker Corp., 724 F.Supp.2d 648, 653 n. 1 (S.D.Tex.2010); Desai v. Sorin CRM USA, Inc., 2013 WL 163298, at *9 (D.N.J. Jan. 15, 2013). “[C]ourts can ascertain earlier in the litigation whether a plaintiff has a proper parallel claim, thus saving the parties from engaging in expensive and unnecessary discovery.” Wells v. Allergan USA, Inc., 2014 WL 117773, *3. Without more from Plaintiff as to how discovery could lead to a proper parallel claim, the court declines to allow discovery in this case. IV. Conclusion The BHR as a Class III medical device received PMA, after its design, manufacture and labeling was approved and the product was found to be safe and effective by the FDA. By contending that the BHR was, nevertheless, defective, Plaintiff seeks to impose requirements regarding the design, manufacture, marketing or labeling of the BHR that are different from, or 14 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 14 of 15 A14 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 15 of 16 PageID #: 145 in addition to, what the FDA approved and therefore are preempted. Riegel, 552 U.S. at 322-25. See also Walker, 670 F.3d at 580 (“A common law tort claim that presupposes a Class III device should have been designed in a manner other than that contemplated by its premarket approval is therefore expressly preempted by the MDA as interpreted by Riegel.”) (citing Riegel, 522 U.S. at 324-25). Based on the foregoing, the court grants Defendant’s Motion to Dismiss. (ECF No. 27). IT IS SO ORDERED. s/Timothy M. Cain United States District Judge February 16, 2016 Anderson, South Carolina 15 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 15 of 15 A15 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 16 of 16 PageID #: 146