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Knoth v. Apollo Endosurgery US, Inc.

United States District Court, S.D. Mississippi, Western Division

November 8, 2019

STEPHANIE S. KNOTH PLAINTIFF
v.
APOLLO ENDOSURGERY US, INC., ET AL. DEFENDANT

          MEMORANDUM OPINION AND ORDER

          DAVID BRAMLETTE UNITED STATES DISTRICT JUDGE.

         This matter is before the Court upon Defendant Apollo Endosurgery US., Inc, (“Apollo”)'s Motion to Dismiss (Doc. 46); Plaintiff Stephanie S. Knoth (“Knoth”)'s Response (Doc. 51) and Defendant Apollo's Reply (Doc. 55). Having considered the motion, the responses, and applicable statutory and case law, and being otherwise fully informed in the premises, the Court GRANTS in part and DENIES in part Apollo's Motion to Dismiss (Doc. 46).

         Background

         This is a medical malpractice and products liability dispute, arising from the implant of the Orbera gastric balloon. The Court incorporates in this Order the lengthy description of the background and underlying facts in this action, discussed in its previous Order (Doc. 29).

         On May 4, 2018, Knoth, representing herself pro se, filed this lawsuit against Apollo and other defendants. Doc. 1. As to Apollo, the Complaint makes standard product liability allegations about Knoth's implant, specifically, that the Orbera balloon was unsafe and defective. Id. at ¶ 31-32. Apollo moved to dismiss the case on the basis that Knoth's claims were preempted under 21 U.S.C. § 360k(a), the Medical Device Amendments Act of 1976. “As provided by § 360k(a), Congress expressly preempted any state tort law ‘requirement' for a device that differs from its federal requirements.” Doc. 47, p. 3.

         Express preemption is an indication of Congress's intention to supersede state law. As such, if Apollo's state law claims are preempted by §360k, this court must dismiss the state law claims as being superseded by the Medical Device Amendments Act (“MDA”) which establishes a system to regulate medical devices. Preemption in this field is especially onerous, as “there is no private right of action to recover damages or other relief under the MDA.” See Blanchard v. Collagen Corp., 909 F.Supp 427, 431 (E.D. La. 1995). Therefore, the only remedy available to plaintiffs is through “traditional state powers, namely, tort compensation and health and safety.” Id.

         Apollo also relies on the United States Supreme Court's decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)(holding that the FDA pre-market approval process established federal requirements and the patient's New York common-law claims of negligence, strict liability, and implied warranty against manufacturer were preempted). Apollo cites Riegel as controlling authority because the FDA approved the Orbera balloon as a Class III medical device after the product went through the pre-market approval process. Doc. 47, p. 3.

         In October 2018, Knoth retained counsel and sought leave to amend her Complaint to plead state-law claims that “parallel” federal law, agreeing that her original state-law claims were preempted. See Docs. 11, 23. This Court granted her leave to amend the Complaint, and she did so. See Docs. 29, 30. Now, Apollo moves to dismiss Knoth's claims against it, pursuant to Fed.R.Civ.P. 12(b)(6). Doc. 46, p. 1.

         Standard

         Rule 12(b)(6) affords a defendant the opportunity to test the legal sufficiency of the complaint, i.e., whether the plaintiff pleads a legal claim for which relief can be sought. See Electrostim Medical Services, Inc. v. Health Care Service Corp., 614 Fed.Appx. 731, 736 (5th Cir. 2015). To survive a motion to dismiss, the plaintiff's claim for relief must be plausible on its face. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)(quoting Bell Atl. Corp. v. Twombly, 550, U.S. 544, 570 (2007)). The plausibility standard requires that the complaint's factual allegations “be enough to raise a right to relief above the speculative level.” Twombly, 550 U.S. at 555. If there is “any evidence in the record from any source from which a reasonable inference in the [nonmoving party's] favor may be drawn, the moving party simply cannot obtain a summary judgment…”. Celotex Corp. v. Catrett, 477 U.S. 317, n.2 (1986)(citing In re Japanese Electronic Products Antitrust Litigation, 723 F.2d 238, 258 (3rd Cir. 1983)).

         Discussion

         1. Pre-Market Approval & Post-Approval Conditions for Class III Devices

         The federal Medical Device Amendments of 1976 (“MDA”) imposed a “regime of detailed federal oversight, ” over the market for medical devices. See Riegel v. Medtronic, Inc., 522 U.S. 312, 316 (2008). Congress entered the field of medical device regulation in order to intentionally sweep back state obligations in favor of uniform federal regulation. See id. To do so, the MDA utilized a two-pronged approach: (1) imposing an “intricate regulatory scheme to increase oversight and promote uniformity at the federal level, ” and (2) eliminating interference by state enforcement agencies through an express preemption clause, 21 U.S.C. §360k. See Raab v. Smith & Nephew, Inc., 150 F.Supp.3d 671, 682 (S.D. W.Va. 2015).

         The degree to which the FDA regulates a medical device depends on the level of classification of the device. The higher the classification the more stringent the regulations. Class III devices are the most highly regulated because the devices are used in supporting or sustaining human life, are substantially important in preventing the impairment of human health, or the devices present an unreasonable risk of illness or injury. See 21 U.S.C. §360(a)(1)(C); Riegel 552 U.S. at 317. Because of this, Class III devices are subjected to extensive regulation before being introduced into the market; specifically, these devices are required to go through a strenuous pre-market approval (“PMA”) process to “provide reasonable assurance of their safety and effectiveness.” Riegel 552 U.S. at 317. Once a medical device successfully obtains PMA, the MDA “forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing process, labelling, or any other attribute, that would affect safety or effectiveness.” Id. at 319(citing 21 U.S.C. §360e(d)(6)(A)(i)).

         In addition to device specific regulations, Class III devices are also subject to Current Good Manufacturing Practices (“CGMPs”). See Bass v. Stryker Corp., 669 F.3d 501, 511-512 (5th Cir. 2012)(citing In re Medtronic, Inc. v. Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1206 (8th Cir. 2010)). The FDA has described CGMPs as “an umbrella quality system” providing “general objectives” for all device manufactures. See In re Medtronic, Inc., 623 F.3d at 1206. The requirements are applicable to “any finished device, as defined in this part, intended for human use.” Rabb, 150 F.Supp.3d at 684 (citing 21 C.F.R. §820.1(a)(2)). The Seventh Circuit articulated the binding nature of CGMPs in its decision in Bausch v. Stryker Corp.;

“… federal law is clear: for manufacturers of Class III medical devices, the Quality System Regulations and Current Good Manufacturing Practices adopted by the FDA under its delegated regulatory authority are legally binding requirements ‘under this chapter.' 21 C.F.R. § 820.1. ‘The failure to comply with any applicable provision in this part [of the regulations] renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.' 21 C.F.R. § 820.1(c).”

630 F.3d 546, 555 (7th Cir. 2010); see also, Howard v. Sulzer Orthopedics, 382 Fed.Appx. 436, 440 (6th Cir. 2010)(finding no legal basis to distinguish between general requirements and device-specific requirements). But see, In re Medtronic, 623 F.3d at 1207 (rejecting claims based on violations of Current Good Manufacturing Practices).

         It should be noted that in order for a plaintiff to bring a claim against the manufacturer there is no requirement that the FDA instigate an enforcement action or make a “formal” finding that the manufacturer is in violation of federal requirements. See Hughes v. Boston Scientific Corp., 631 F.3d 762, 772-773 (5th Cir. 2011).

         After PMA (pre-market approval), manufacturers of Class III devices must comply with a variety of post-approval conditions. See Hughes 631 F.3d at 765(citing 21 U.S.C. §§360c-360j; 21 C.F.R. §§ 814.80, 814.82). If the manufacturer fails to comply with the these conditions, the FDA may withdraw PMA. See id. The FDA can also impose other remedies such as “additional warnings or corrective labeling.” Id.

         The PMA process and post-approval regulations are one factor in the MDA's coverage of the medical devices field. For a holistic view of this highly regulated area, the Court next looks to the MDA's pre-emption of state law claims.

         2. Pre-Emption Under the MDA and Parallel State Law Claims

         Section 360k of the MDA contains an express preemption provision that states:

“no State… may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.”

21 U.S.C. §360k(a).

         A two-pronged test determines whether Section 360k expressly preempts a state law claim: (1) whether the federal government has established requirements applicable to the medical device, and (2) if so, whether the state law claim would impose requirements that are “different from or in addition to” the federal requirements. See Riegel, 552 U.S. at 321-322. The first prong is satisfied when a Class III device has undergone the pre-market approval (“PMA”) process. See Bass, 669 F.3d at 507.

         The second prong permits a State to provide a remedy for damages for claims premised on a violation of FDA regulations or CGMPs, as long as the claim parallels the federal regulations. See Bass, 669 F.3d at 509. The parallel claims doctrine allows plaintiffs to employ state tort law as a “mechanism for enforcing federal requirements.” See Raab, 150 F.Supp.3d at 686. In Medtronic, Inc. v. Lohr, the Supreme Court rejected the idea that Congress intended to preclude all common-law causes of action by enacting §360k. 518 U.S. 470, 487 (1996). Such a restriction would effectively remove “all means of judicial recourse for those injured by illegal conduct.” Id. As the Supreme Court wrote in Lohr, “Medtronic's construction of §360k would therefore have the perverse effect of granting complete immunity from design defect liability to an entire industry that, in the judgment of Congress, needed more stringent regulation…” Id.

         The Fifth Circuit has held that the PMA process “preempts state tort causes of action to the extent that they relate to safety, effectiveness, or other MDA requirements.” Gomez v. St. Jude Medical Diag. Div. Inc., 442 F.3d 919, 929 (5th Cir. 2006). To avoid preemption, the general assertions of a state law cause of action cannot “threaten the federal PMA process requirements.” See id. at 929-930. However, in cases where a manufacturer is not protected from state tort liability by §360k preemption, the claims are based on violation of applicable federal requirements. See Williams v. Ciba Vision Corp., 100 F.Supp.3d 585, 590 (S.D.Miss. 2015)(citing Hughes, 631 F.3d at 767)).

         After the issue of express preemption has been addressed, courts often look to the issue of implied preemption, but inasmuch as the Defendant has not addressed this issue, the Court is not inclined to do so.

         Applying Riegel's two-pronged test to Knoth's claim, we first consider whether the FDA has established requirements applicable to the Orbera gastric balloon. Any Class III device that has received PMA by the FDA satisfies the first prong of the test. See Bass, 669 F.3d at 507. As evidenced by the complaint, the Orbera gastric balloon is a Class III device that has received PMA and therefore the first prong is satisfied. To satisfy the second prong, we must ask whether state law at issue parallels the federal requirement or if it creates a requirement that is “different from or in addition to a federal requirement.” 21 U.S.C. §360k. Thus, we consider below the elements of Knoth's state-law claims to determine whether they are parallel to the federal requirements.

         Mississippi Products Liability Act

         Knoth brings suit under The Mississippi Products Liability Act (“MPLA”) and Mississippi common law. The MPLA applies “in any action for damages caused by a product.” Miss. Code. Ann. §11-1-63. The Defendant argues that the MPLA subsumes five of the Plaintiff's claims and that they should be dismissed inasmuch as the MPLA is the exclusive remedy for a products liability claim: (1) Breach of Implied Warranty, (2) Unjust Enrichment, (3) Lack of Informed Consent, (4) violations of the Mississippi Deceptive Trade Practices Act, and (5) Negligent Training and Proctoring & Negligent Certification.

         The legislature enacted the MPLA in 1993. At that time, it was unclear as to what extent the MPLA supplanted pre-existing products liability causes of action. See Mississippi Law of Torts §15:3(“MLT”). However, in 2014, the legislature amended the MLPA to include “designers” as entities to whom or to which the MLPA applies. The amendment also added “negligence” as a common law action subsumed by the MLPA. See MLT §15:3. As amended, the MPLA applies to “any action for damages caused by a product, including, but not limited to, any action based on a theory of strict liability in tort, negligence or breach of implied warranty, except for commercial damage to the product itself.” Miss. Code Ann. §11-1-63. The MPLA recognizes three traditional categories of product defects: (1) design defects, (2) warnings/instructions defects, and (3) manufacturing defects. See MLT § 15:3.

         There have been recent clarifications as to the MPLA's relationship to state common law claims. Prior to 2014, the issue was unsettled, with the Mississippi Supreme Court indicating that the MPLA supplemented rather than supplanted implied warranty actions. See MLT §15:3(citing Bennett v. Madakasira, 821 So.2d 794, 808 (Miss. 2002)(holding that the MPLA does not preclude a plaintiff from proceeding under a breach of implied warranty theory in a products liability case)(emphasis added)). However, the 2014 amendments and the Mississippi Supreme Court's decision in Elliot v. El Paso Corp. have clarified the state's approach to these issues. 181 So.3d 263 (Miss. 2015). In Elliot the Mississippi Supreme Court wrote,

“In interpreting and applying the MPLA, we have explained that ‘the MPLA provides the exclusive remedy' for products-liability claims, and ‘since [the enactment of the MPLA], products-liability claims have been specifically governed by statute, and a claimant, in presenting his case, must pay close attention to the elements of the cause of action and the liability limitations enumerated in the statute.' In other words, the MLPA has abrogated products-liability claims based on strict-liability or negligence theories, and the MPLA now provides the roadmap for such claims.”

Id. at 268. The court also noted that a case involving a product defect - even a claim for breach of implied warranty - would be subsumed by the MPLA. Id. at n.24.

         Common Law Claims

         Defendants argue in their Motion that the MPLA subsumes Knoth's common law claims and those claims must be dismissed. The MPLA, which applies “in any action for damages caused by a product, including, but not limited to, any action based on a theory of strict liability in tort, negligence, or breach of implied ...


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