UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TENNESSEE
`AT KNOXVILLE
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`Case No. 3:20-cv-418
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`Judge Atchley
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`Magistrate Judge McCook
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`KELLY PAINTER-HART, et al.,
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`Plaintiffs,
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`v.
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`SIENTRA, INC.,
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`Defendant.
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`MEMORANDUM AND ORDER
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`Before the Court is a Motion to Dismiss for Failure to State a Claim [Doc. 22] filed by
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`Defendant Sientra, Inc. Plaintiffs Kelly Painter-Hart and Seth Hart responded [Doc. 27] and
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`Defendant replied. [Doc. 29]. Additionally, Plaintiffs and Defendant have filed supplemental
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`authority and briefing in support of their positions. [Docs. 34, 35, 37, 38, 44, 45, 46, 47, 53, 54].
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`For the reasons below, Defendant’s Motion to Dismiss [Doc. 22] is GRANTED.
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`I.
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`FACTUAL BACKGROUND
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`This is a products liability action related to breast implants that were used in Plaintiff
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`Painter-Hart’s breast reconstruction surgery. [Doc. 1].1
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`A. Medical Device Classification and PMA Process
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`In 1976, Congress introduced the Medical Device Amendments (“MDA) to the Federal
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`Food, Drug, and Cosmetic Act (“FDCA”). The MDA established a comprehensive regulatory
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`regime for medical devices to be implemented by the Food and Drug Administration (“FDA”).
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`1 For consistency and ease of reference, record citations are to the CM/ECF-stamped document and page number, not
`to the internal pagination of any filed document. Where possible, citation is made to more specific subdivisions within
`a document.
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`Before the MDA was enacted, “states individually were left to regulate medical devices. Now,
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`Congress has swept back some state obligations and imposed a regime of detailed federal
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`oversight.” Hafer v. Medtronic, Inc., 99 F. Supp. 3d 844, 850 (W.D. Tenn. 2015) (internal citations
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`omitted).
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`Under the MDA, medical devices receive varying levels of scrutiny from the FDA
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`depending on the risks they present. Class III medical devices incur the highest level of federal
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`oversight under 21 U.S.C. § 360(c)(1)(C); and must receive FDA approval before entering the
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`market through a process known as “premarket approval” (“PMA”). Id. Manufacturers must
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`submit a PMA application for FDA approval, including, among other things, “full reports of all
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`studies and investigations of the device’s safety and effectiveness that have been published or
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`should reasonably be known to the applicant; a full statement of the device’s components,
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`ingredients, and properties and of the principle or principles of operation; a full description of
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`the methods used in, and the facilities and controls used for the manufacture, processing, and
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`when relevant, packing and installation of such device; samples or device components required
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`by the FDA; and a specimen of the proposed labeling.” Riegel v. Medtronic, Inc., 552 U.S. 312,
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`318 (2008) (internal citations omitted).
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`The FDA spends an average of 1,200 hours reviewing PMA applications; and will only
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`grant premarket approval if it determines that there is “reasonable assurance” of the device’s
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`“safety and effectiveness.” Id. Once a device has received premarket approval, it “may not be
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`manufactured, packaged, stored, labeled, distributed, or advertised in a manner…inconsistent
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`with any conditions to approval specified in the PMA approval order for the device.” 21 C.F.R. §
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`814.80. Therefore, a manufacturer seeking to make such changes must apply for supplemental
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`premarket approval (“PMA Supplement”); and must then await FDA approval pursuant to the
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`same rigorous standard of review that is applied during the initial PMA process. 21 U.S.C. §
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`360(e)(d)(6); 21 C.F.R. § 814.39(a).
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`B. Sientra’s Breast Implants
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`Defendant Sientra, Inc. (“Sientra”) manufactures and sells medical devices, including
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`silicone gel breast implants. [Doc. 1 at ¶ 4]. Defendant’s breast implants are Class III medical
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`devices that underwent the PMA process. [Doc. 23 at 9].
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`In March 2012, the FDA approved Defendant’s PMA application for silicone gel breast
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`implants. [Docs. 1 at ¶ 17; 23-1]. Defendant’s PMA application included safety and efficacy
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`information, proposed labeling and warnings, and a description of the proposed manufacturing
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`process. [Doc. 23 at 13]. Upon receiving FDA approval, Defendant was allowed to begin
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`distributing the silicone gel breast implants in accordance with specific conditions outlined in
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`the PMA approval letter. [Doc. 1 at ¶ 17]. The PMA conditions required submission of various
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`reports to the FDA: annual reports, adverse event reports, and post-approval study reports with
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`particular data requirements. [Docs. 1 at ¶¶ 17-18; 23-1]. Additionally, Defendant was subject to
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`general FDA regulations, including Current Good Manufacturing Processes (“CGMP”), Quality
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`System Regulations (“QSRs”), and requirements regarding contractor selection, testing, and
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`quality control. [Doc. 1 at ¶¶ 19, 22].
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`After receiving FDA approval through the PMA process, Defendant began selling its
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`silicone gel breast implants, both textured and smooth varieties, to plastic surgeons in the United
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`States and Canada. [Doc. 1 at ¶¶ 4, 16, 24-26]. At all times relevant to this litigation,
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`Defendant contracted with Silimed Industria de Implantes LTDA (“Silimed”), a Brazilian
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`company, to manufacture Defendant’s implants in accordance with the PMA specifications
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`approved by the FDA. [Id. at ¶¶ 17-18, 26-27, 38].
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`C. Plaintiff’s Claims
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`In November 2013, Plaintiff Painter-Hart had a double mastectomy in Knoxville,
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`Tennessee; and Defendant’s textured silicone gel breast implants were used for her breast
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`reconstruction surgery. [Id. at ¶ 7]. Plaintiff claims neither she, nor her plastic surgeon, were
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`informed of any increased risks associated with the breast implants or the use of a medical
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`device manufactured in Brazil, nor of any quality control issues that could impact her health,
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`safety, or well-being. [Id. at ¶¶ 8, 10].
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`In September 2019, Plaintiff returned to her surgeon with complaints of swelling in her
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`right breast. [Id. at ¶ 11]. Plaintiff’s surgeon ordered an ultrasound to evaluate the possibility of
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`breast implant associated anaplastic large cell lymphoma (“BIA-ALCL”). [Id.]. In October 2019,
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`an oncologist confirmed the presence of BIA-ALCL in Plaintiff’s right breast. [Id. at ¶ 12]. In
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`November 2019, Plaintiff’s breast implants were removed. [Id. at ¶ 13]. Plaintiff has since
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`required, and will continue to need, medical care, testing, and monitoring related to her BIA-
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`ALCL. [Id. at ¶ 14].
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`II.
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`PROCEDURAL BACKGROUND
`Plaintiff claims that Defendant’s silicone gel breast implants caused her to develop BIA-
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`ALCL, as they were defective, unreasonably dangerous, and/or adulterated, and were not
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`manufactured in compliance with applicable laws, regulations, and/or standards. [Id. at ¶ 15].
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`Plaintiff and her husband assert three products liability claims under Tennessee law: (1) Strict
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`Liability—Failure to Warn; (2) Strict Liability—Manufacturing Defect; and (3) Negligence. [Id.
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`at 20-27].2
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`2 Plaintiffs also assert a claim for breach of express and implied warranties. [Doc. 1 at 27-29]. However, in briefing
`the instant motion, Plaintiffs have agreed to dismiss their breach of warranty claims. [Doc. 27 at 25].
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`In response, Defendant filed the Motion to Dismiss now before the Court. [Doc. 22].
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`Defendant claims Plaintiffs’ state law claims are preempted by federal law; and alternatively,
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`Plaintiffs have failed to state plausible claims for relief. [Id.].
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`III.
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`STANDARD OF REVIEW
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`A Rule 12(b)(6) motion to dismiss tests the sufficiency of the complaint by arguing the
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`allegations establish no claim for which relief can be granted. Fed. R. Civ. P. 12(b)(6). In
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`considering a motion to dismiss under Rule 12(b)(6), the Court “must construe the complaint in
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`the light most favorable to the plaintiff, accept all of the complaint’s factual allegations as true,
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`and determine whether the plaintiff undoubtedly can prove no set of facts in support of his claim
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`that would entitle him to relief.” Engler v. Arnold, 862 F.3d 571, 574-75 (6th Cir. 2017) (internal
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`quotations omitted).
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`“The [plaintiff's] factual allegations, assumed to be true, must do more than create
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`speculation or suspicion of a legally cognizable cause of action; they must show entitlement to
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`relief.” League of United Latin Am. Citizens v. Bredesen, 500 F.3d 523, 527 (6th Cir. 2007). “Mere
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`labels and conclusions are not enough; the allegations must contain ‘factual content that allows
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`the court to draw the reasonable inference that the defendant is liable for the misconduct
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`alleged.’” Id. at 575 (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)). “Threadbare recitals of
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`the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Iqbal,
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`556 U.S. at 678. Furthermore, the Court is “not bound to accept as true a legal conclusion couched
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`as a factual allegation.” Papasan v. Allain, 478 U.S. 265, 286 (1986).
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`“In evaluating a motion to dismiss, [the Court] ‘may consider the complaint and any
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`exhibits attached thereto, public records, items appearing in the record of the case and exhibits
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`attached to defendant’s motion to dismiss so long as they are referred to in the complaint and are
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`central to the claims contained therein.’” Ryniewicz v. Clarivate Analytics, 803 F. App’x. 858, 863
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`(6th Cir. 2020) (quoting Luis v. Zang, 833 F.3d 619, 626 (6th Cir. 2016)). Therefore, the Court
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`may consider a 2015 Securities and Exchange Commission’s (“SEC”) regulatory decision
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`directed towards Sientra, as this document is referenced by Plaintiffs several times in their
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`Complaint. [Docs. 1 at ¶¶ 27, 58; 23-1; 23-2].
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`IV. ANALYSIS
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`Defendant seeks dismissal of the Complaint pursuant to Fed. R. Civ. P. 12(b)(6), claiming
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`Plaintiffs’ state law claims are preempted by federal law; and alternatively, Plaintiffs have failed
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`to state plausible claims for relief. [Doc. 22].
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`a. Preemption
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`The doctrine of preemption stems from the Supremacy Clause of the United States
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`Constitution, which provides that the “Constitution, and the laws of the United States…shall be
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`supreme Law of the Land.” U.S. Const. art. VI, cl. 2.; Yates v. Ortho-McNeil-Janssen Pharms.,
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`Inc., 808 F.3d 281, 293 (6th Cir. 2015). In practice, the Supremacy Clause instructs that courts
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`“must not give effect to state laws that conflict with federal laws.” Torres v. Precision Indus.,
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`Inc., 938 F.3d 752, 754 (6th Cir. 2019) (quoting Armstrong v. Exceptional Child Ctr. Inc., 135 S.
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`Ct. 1378, 1883 (2015)). “State-law claims can be preempted expressly in a federal statute or
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`regulation, or impliedly, where congressional intent to preempt state law is inferred.” Yates, 808
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`F.3d at 293. (internal citations omitted). “[P]reemption is an affirmative defense upon which []
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`defendants bear the burden of proof.” Brown v. Earthboard Sports USA, Inc., 481 F.3d 901, 912
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`(6th Cir. 2007).
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`Defendant contends, through the MDA, Congress established a comprehensive federal
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`scheme to regulate Class III medical devices; therefore, federal law expressly or impliedly
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`preempts most state law products liability claims related to the safety or effectiveness of FDA
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`approved Class III medical devices. [Doc. 23 at 9, 15]. Because the breast implants at issue are
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`Class III medical devices approved by the FDA, Defendant argues Plaintiffs’ state law claims
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`are both expressly and impliedly preempted by federal law. [Id.].
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`It is well-established that state law tort and products liability claims relating to an FDA
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`approved medical device are often preempted by the MDA. See White v. Medtronic, Inc., 808 F.
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`App’x 290, 293-94 (6th Cir. 2020); In re Allergan Biocell Textured Breast Implant Prod. Liab.
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`Litig., 537 F. Supp. 3d 679 (D.N.J. 2021); Smith v. ZOLL Med. Corp., 505 F. Supp. 3d 787, 796-
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`97 (W.D. Tenn. 2020). The MDA encompasses both express and implied preemption of state
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`law claims.
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`The MDA contains a broad express preemption provision: “no State…may establish or
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`continue in effect with respect to a device intended for human use any requirement (1) which is
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`different from, or in addition to, any requirement applicable under this chapter to the device; and
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`(2) which relates to the safety and effectiveness of the device or to any other matter included in a
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`requirement applicable to the device under this chapter.” 21 U.S.C. § 360(k)(a); see also 21 C.F.R.
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`§ 808.1(d). Thus, the MDA expressly preempts state law claims that would impose any
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`requirement related to the “safety and effectiveness” of an FDA approved medical device that is
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`“different from, or in addition to” applicable federal requirements. 21 U.S.C. § 360(k)(a); Riegel,
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`552 U.S. at 323.
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`Further, 21 U.S.C. § 337(a) provides that all actions to enforce the FDCA “shall be by
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`and in the name of the United States.” The Supreme Court construed this provision as barring
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`private lawsuits that attempt to enforce provisions of the FDCA. Buckman Co. v. Plaintiffs’
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`Legal Comm., 531 U.S. 341, 352 (2001) (“The FDCA leaves no doubt that it is the Federal
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`Government rather than private litigants who are authorized to file suit for noncompliance with
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`medical device provisions[.]”) Thus, private litigants cannot bring a state law claim that is, in
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`substance, one to enforce the FDCA. Hafer, 99 F. Supp. 3d at 856 (citing Caplinger v.
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`Medtronic, Inc., 921 F. Supp. 2d 1206, 1214 (W.D. Okla. 2013)).
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`Combined, “[e]xpress and implied preemption leave a ‘narrow gap’ through which a
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`plaintiff may state a claim for injuries caused by a medical device.” Smith, 505 F. Supp. 3d at 797
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`(collecting cases). To fit through the narrow gap, a claim must be predicated on conduct that
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`violates the FDCA, but may not be brought solely because that conduct violates the FDCA—the
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`conduct must also violate a parallel state law requirement. Hafer, 99 F. Supp. 3d at 857 (internal
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`citations omitted). “Put differently, to survive preemption, a plaintiff must allege conduct that (1)
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`violates the FDCA (because state law may not impose additional or different duties) and (2) would
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`be actionable under state law independent[] of the FDCA (because a plaintiff may not seek to
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`enforce the FDCA).” Brooks v. Mentor Worldwide, LLC, 985 F.3d 1272, 1279 (10th Cir. 2021);
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`Sadler v. Advanced Bionics, Inc., 929 F. Supp. 2d 670, 679 (W.D. Ky. 2013).
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`i. Express Preemption
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`The Supreme Court has established a two-part test for deciding whether claims are
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`expressly preempted. Riegel, 552 U.S. at 321-22. First, the Court must ask “whether the federal
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`government has established requirements applicable to” the medical device at issue. Id. Second,
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`the Court must determine whether state law imposes any requirements related to the safety or
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`effectiveness of the medical device “different from, or in addition to” the applicable federal
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`requirements. Id. When both prongs are satisfied, a state law claim is expressly preempted.
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`The Supreme Court has recognized that “[p]remarket approval…imposes [federal]
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`‘requirements’” as that term is used in § 360(k)(a). Riegel, 552 U.S. at 321. Thus, state law
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`claims that involve a medical device approved through the PMA process automatically satisfy
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`the first condition for express preemption. Kemp v. Medtronic, Inc., 231 F.3d 216, 226-28 (6th
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`Cir. 2000); Smith, 505 F. Supp. 3d at 797. Accordingly, as Defendant’s breast implants were
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`approved through the PMA process, there are federal requirements applicable to the device at
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`issue; and the first condition for express preemption is satisfied.
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`The Court’s analysis will focus on the second condition for express preemption: whether
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`requirements stemming from Plaintiffs’ state law claims differ from, or add to, the applicable
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`federal requirements. If a state law claim imposes standards that merely parallel federal
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`requirements, then express preemption does not apply. Hafer, 99 F. Supp. 3d at 856. State law
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`claims “premised on a violation of FDA regulations” evade express preemption, as they do not
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`impose requirements “different from, or in addition to” federal law. Riegel, 552 U.S. at 324-25;
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`see also Freed v. St. Jude Med., Inc., 364 F. Supp. 3d 343, 350 (D. Del. 2019) (“The MDA’s
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`express preemption provision does not apply to parallel claims—that is, to claims premised on
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`state requirements that merely incorporate federal requirements and therefore are not different
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`from or in addition to the federal requirements.”) (internal citations omitted). But “if a
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`manufacturer could be held liable under [] state law without having violated [] federal law,” the
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`state law claims are not “parallel” and express preemption applies. Id. (quoting Houston v.
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`Medtronic, Inc., 957 F. Supp. 3d 1166, 1174 (C.D. Cal. 2013)).
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`The parties do not dispute that Plaintiffs’ claims relate to the safety and effectiveness of
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`Defendant’s breast implants. Thus, the relevant question is whether Plaintiffs’ state law claims
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`impose requirements “different from, or in addition to” federal requirements imposed through
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`the PMA process.
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`Strict Liability: Failure to Warn
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`The FDA approved Defendant’s labeling and warnings for the breast implants during the
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`PMA process; and Plaintiffs do not allege that Defendant deviated from the FDA approved
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`warning label in any respect. Instead, Plaintiffs seek to hold Defendant liable for its failure to
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`update the warning label. [Doc. 27 at 17-20]. Plaintiffs claim the federal regulations allowed
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`Defendant to update the warning label based on newly acquired information; Defendant was
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`made aware of ongoing risks related to the breast implants; and thus, considering such
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`information, Defendant should have, but failed to, update the warning label to warn of relevant
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`risks. [Docs. 1 at ¶¶ 27, 38-39, 42-43, 47-49, 53; 27 at 18].
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`The Court finds that Plaintiffs’ failure to warn claim is expressly preempted under 21
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`U.S.C. § 360 (k)(a), as it seeks to impose requirements “different from, or in addition to” federal
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`requirements. Plaintiffs do not argue that the federal regulations required Defendant to update its
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`warning labels; rather, Plaintiffs merely claim that 21 C.F.R. § 814.39(d) “enable[d] [Defendant]
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`to change its labeling/warnings” without FDA approval. [Doc. 27 at 18]. While Plaintiffs are
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`correct that Defendant could have changed its labeling prior to obtaining FDA approval through
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`a permissive mechanism, such action was not mandatory. See 21 C.F.R. § 814.39(d) (“After FDA
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`approves a PMA, any change…to reflect newly acquired information that enhances the safety of
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`the device or the safety in the use of the device may be placed into effect by the applicant prior to
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`the receipt…of a written FDA order approving the PMA supplement…”) (emphasis added). Under
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`federal law, Defendant was allowed, but not required, to change its warning label before FDA
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`approval. And, absent a federal requirement to update the warning label, Plaintiffs' failure to
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`warn claim seeks to impose a warning requirement under state law “different from or in addition
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`to” the federal scheme and is therefore expressly preempted.3 4
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`Manufacturing Defect
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`Defendant contends that Plaintiffs’ manufacturing defect claim cannot evade express
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`preemption, as Plaintiffs fail to identify the specific federal regulations or PMA requirements it
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`allegedly violated; and without such specificity, the Court cannot determine whether the
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`manufacturing defect claim will impose a requirement “different from or in addition to” the
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`applicable federal regulations. [Doc. 23 at 20-21]. Put differently, Defendant contends that
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`Plaintiffs fail to assert a “parallel” state law claim sufficient to avoid express preemption by
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`referencing broad categories of federal regulations.
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`Courts are divided regarding the degree of specificity required to plead a “parallel” state
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`law claim sufficient to avoid express preemption. Kiser v. Terumo Med. Corp., 2021 WL
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`4356044, at *4-6 (E.D. Tenn. Sept. 23, 2021); see also Waltenburg v. St. Judge Med., Inc., 33 F.
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`Supp.3d 818, 827-32 (W.D. Ky. 2014). Decisions from the Seventh and Eleventh Circuits occupy
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`3 See Cupek v. Medtronic, 405 F.3d 421, 424 (6th Cir. 2005) (holding any state law claim alleging failure to warn
`beyond warnings required by the FDA would impose a state requirement “different from, or in addition to” federal
`PMA requirements and thus is expressly preempted); Spier v. Coloplast Corp., 121 F. Supp. 3d 809, 817 (E.D. Tenn.
`2015) (finding a claim that sought to impose liability for failure to include warnings beyond those required by the
`FDA was expressly preempted); Hafer, 99 F. Supp.3d at 860 (finding failure to warn claim that sought to impose
`liability for failure to provide warnings “above and beyond those…that were specifically approved by the FDA as part
`of the PMA process” was expressly preempted); Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994, 1005 (S.D. Ohio
`2016) (“[T]o the extent that Plaintiffs allege that Defendants were required to give any warning other than those that
`were required by the FDA…those claims are expressly denied as being inconsistent with federal law.”); In re Allergan
`Biocell Textured Breast Implant Prod. Liab. Litig., 537 F. Supp. 3d 679, 709 (D.N.J. 2021) (collecting cases) (finding
`a failure to warn claim that sought to impose liability based on manufacturer’s failure to update its warning labels
`before receiving FDA approval was expressly preempted); McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir.
`2005) (“Where a federal requirement permits a course of conduct and the state makes it obligatory, the state’s
`requirement is in addition to the federal requirement and thus is preempted.”) (emphasis added).
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` 4
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` Plaintiffs draw the Court’s attention to Mitchell v. Boehringer Ingelheim Pharm., Inc., 2017 WL 5617473 (W.D.
`Tenn. Nov. 1, 2017), highlighting that the district court rejected a preemption argument with regard to a similar failure
`to warn claim. [Doc. 27 at 19]. However, the Court finds Mitchell is inapposite, as the decision addressed state law
`claims against a prescription drug manufacturer, and “Congress has not enacted an [express preemption provision]
`for prescription drugs” as it has for medical devices. Wyeth v. Levine, 555 U.S. 555, 574 (2009).
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`opposite ends of the spectrum. Kiser, 2021 WL 456044, at *4-6 (citing Bausch v. Stryker Corp.,
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`630 F.3d 546 (7th Cir. 2010); Wolicki-Gables v. Arrow Int’l, Inc., 624 F.3d 1296, 1301 (11th Cir.
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`2011)).
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`In Bausch v. Stryker Corp., the Seventh Circuit required the least specificity to plead a
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`“parallel” claim that survives a motion to dismiss. 630 F.3d 546 (7th Cir. 2010). “The Seventh
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`Circuit rejected the defendant’s argument that the plaintiff’s product-liability claims should be
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`dismissed for failure to ‘specify the precise defect or the specific federal regulatory requirements
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`that were allegedly violated.’ The court held that, ‘[a]lthough the complaint would be stronger
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`with such detail,’ the absence of those details did not run afoul of Rule 8. In so holding, the
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`Seventh Circuit emphasized: “(1) ‘[t]here are no special pleading requirements for product liability
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`claims in general, or for Class III medical device claims in particular’; (2) ‘the victim of a
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`genuinely defective product…may not be able to determine without discovery and further
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`investigation whether the problem is a design problem or a manufacturing problem’; and (3) ‘in
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`the context of Class III medical devices, much of the critical information’ including ‘[t]he
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`specifications of the FDA’s premarket approval documents’—‘is kept confidential as a matter of
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`federal law.’” Kiser, 2021 WL 4356044, at *4 (quoting Bausch, 630 F.3d at 558-60). The Seventh
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`Circuit explained “[f]ormal discovery is necessary before a plaintiff can fairly be expected to
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`provide a detailed statement of the specific bases for her claim.” Bausch, 630 F.3d at 558.
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`However, in Wolicki-Gables v. Arrow Int’l, Inc., the Eleventh Circuit adopted a more
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`restrictive approach. 624 F.3d 1296 (11th Cir. 2011). The Eleventh Circuit held, in order to
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`survive a motion to dismiss, a plaintiff “must allege that ‘[the] defendant violated a particular
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`federal specification referring to the device at issue.’” Id. at 1301 (quoting Ilarraza v. Medtronic,
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`Inc., 667 F. Supp.2d 582, 589 (E.D.N.Y. 2009)). “In Wolicki-Gables, the Eleventh Circuit upheld
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`the district court’s preemption finding because the complaint’s allegations did not ‘set forth any
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`specific problem, or failure to comply with any FDA regulation that can be linked to the injury
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`alleged.’” Kiser, 2021 WL 4356044, at *5 (quoting Wolicki-Gables, 624 F.3d 1296 (internal
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`citations omitted)). The Eleventh Circuit explained “[p]laintiffs cannot simply incant the magic
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`words ‘[d]efendants violated the FDA regulations’ in order to avoid preemption.” Wolicki-Gables,
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`624 F.3d at 1301 (quoting In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F.
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`Supp. 2d 1147, 1158 (D. Minn. 2009)).
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`As expected, Defendant cites Wolicki-Gables and Plaintiffs cite Bausch in support of
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`their respective positions. [Docs. 23 at 20; 27 at 17]. However, “the Sixth Circuit has not
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`recognized either Bausch or Wolicki-Gables as more compelling.” Kiser, 2021 WL 4356044, at
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`*5. In fact, the Sixth Circuit has yet to directly weigh in on this issue. Therefore, the question
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`remains—“is it sufficient to allege that [Defendant] violated FDA regulations by deviating from
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`the FDA-approved processes and procedures in the PMA, or instead, must the Plaintiffs
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`identify the particular FDA regulations and set forth facts pointing to the particular PMA
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`requirements that are alleged to have been violated?” Waltenburg, 33 F. Supp. 3d at 829.
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`District courts in this circuit have followed the less restrictive approach taken in Bausch.
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`That is, “many district courts have agreed that allegations that a manufacturer deviated from the
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`terms of the device’s premarket approval, or a particular FDA regulation are sufficient to survive
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`dismissal at the pleadings stage.” Kiser, 2021 WL 4356044, at *5-6 (collecting cases).5 These
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`courts have allowed discovery prior to deciding the preemption issue, emphasizing that PMA
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`5 See also Hawkins, 909 F. Supp. 3d at 905; Engle v. Medtronic, Inc., 2021 WL 1318322, at *5 (W.D. Ky. Apr. 8,
`2021) (following Bausch and declining to dismiss state law claims prior to engaging in discovery); Brook v. sanofi-
`aventis U.S., LLC, 2014 WL 7272243, at *3 (S.D. Ohio Dec. 18, 2014) (following Bausch, recognizing that “a
`plaintiff’s pleading burden should be commensurate with the amount of information available to them”).
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`Case 3:20-cv-00418-CEA-JEM Document 57 Filed 02/28/22 Page 13 of 30 PageID #: 539
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`

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`documents are kept confidential as a matter of federal law and thus are inaccessible to plaintiffs
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`before filing a lawsuit. Id.
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`The Court is persuaded by this precedent. When Plaintiffs filed their Complaint, there
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`had been no opportunity for discovery. Plaintiffs explicitly alleged “the premarket application
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`(PMA) process is generally confidential, and documents generated as part of that process are not
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`subject to public disclosure,” “additional information is expected to be developed during discovery
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`regarding the specific requirements applicable to [Defendant],” and, thus, their claims could not
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`“be plead with any greater specificity, as Plaintiffs do not yet have access to all relevant
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`documents.” [Doc. 1 at ¶ 21]. Accepting these allegations as true, as the Court must, it is hard to
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`conceive how Plaintiffs could have pled more specific allegations concerning the PMA
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`requirements applicable to, and allegedly violated by, Defendant without access to the PMA
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`records.
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`Furthermore, as explained above, state law claims “premised on a violation of FDA
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`regulations” evade express preemption because they impose standards “parallel,” rather than
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`“different from, or in addition to,” the federal requirements. Riegel, 552 U.S. at 324-25.
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`Plaintiffs’ manufacturing defect claim appears to be premised on an adulteration theory under
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`T.C.A. § 53-10-106(a)(2), a Tennessee statute that explicitly incorporates federal standards.
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`[Doc. 1 at ¶¶ 6, 40-41, 44, 54, 61-62, 65-68, 75-76, 100].6 Specifically, Plaintiffs claim that the
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`breast implants were defective and/or unreasonably dangerous because they were “adulterated” as
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`defined in T.C.A. § 53-10-106(a)(2); and such adulteration occurred as a result of Defendant’s
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`non-compliance with federal manufacturing requirements. [Id.].
`
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`6 T.C.A. 53-10-106(a)(2) provides, “[a]ny drug or device that is deemed misbranded or adulterated by federal law is
`deemed misbranded or adulterated within the purview of this section.”
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`Case 3:20-cv-00418-CEA-JEM Document 57 Filed 02/28/22 Page 14 of 30 PageID #: 540
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`14
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`Therefore, as it appears Plaintiffs’ manufacturing defect claim is premised on a state
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`statute that incorporates federal standards, the Court finds that Plaintiffs have alleged a parallel
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`claim sufficient to survive express preemption. And, because formal discovery is needed before
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`asserting a more specific claim, Plaintiffs’ reference to broad categories of federal regulations is
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`sufficient to demonstrate a “parallel” claim at this stage of the litigation. See Hawkins v.
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`Medtronic, Inc., 909 F. Supp. 2d 901, 905 (S.D. Ohio 2012) (citing Medtronic, Inc. v. Lohr, 518
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`U.S. 470, 495 (1996)) (“Where the preemption issue is decided on the pleadings, and…‘it is clear
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`the allegations…may include claims that [defendant] has, to the extent that they exist, violated
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`FDA regulations,’ the Supreme Court has held [] these claims ‘can be maintained without being
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`pre-empted by § 360k.’”); Kiser, 2021 WL 4256044, at *4-6; Riegel, 552 U.S. at 330 (explaining
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`that § 360(k) “does not prevent a State from providing a damages remedy for claims premised on
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`a violation of FDA regulations; the state duties in such case ‘parallel,’ rather than add to, federal
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`requirements”).
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`Negligence
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`The parties agree that Plaintiffs’ negligence claim substantially overlaps with their strict
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`liability claim for failure to warn. [Docs. 23 at 26; 27 at 21]. Consequently, for the same reason
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`that Plaintiffs’ failure to warn claim is expressly preempted, Plaintiffs’ negligence claim is
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`expressly preempted to the extent that it is premised on Defendant’s failure to provide adequate
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`warnings. Supra at 9-11.
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`ii. Implied Preemption
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`The Supreme Court has found “clear evidence that Congress intended that the MDA be
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`enforced exclusively by the Federal Government.” Buckman, 531 U.S. at 352. Thus, private
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`litigants cannot bring a state law claim that is, in substance, one to enforce the FDCA. Id.; Hafer,
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`Case 3:20-cv-00418-CEA-JEM Document 57 Filed 02/28/22 Page 15 of 30 PageID #: 541
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`15
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`99 F. Supp. 3d at 856 (citing Caplinger, 921 F. Supp. 2d at 1214 (W.D. Okla. 2013)). Put
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`differently, private litigants cannot assert state