Bayer Corp. v. Leach

153 N.E.3d 1168

BAYER CORPORATION, et al., Appellants-Defendants,

v.Rene LEACH, et al., Appellees-Plaintiffs.

Court of Appeals Case No. 19A-CT-625

Court of Appeals of Indiana.

FILED August 19, 2020

Attorneys for Appellants: Robert A. Jorczak, Ice Miller LLP, Indianapolis, Indiana, Erika L. Maley, Christopher A. Eiswerth, Sidley Austin LLP, Washington, DC

Attorneys for Appellees: Lee C. Christie, Katherine A. Franke, Cline Farrell Christie Lee & Bell, P.C., Indianapolis, Indiana, Gregory J. Bubalo, Katherine A. Dunnington, Bubalo Law PLC, Louisville, Kentucky

Bailey, Judge.

Case Summary

[1] Rene Leach and more than thirty other women (collectively, the "Women") claim that they were physically injured by a medical device called Essure, which was marketed as a form of permanent birth control. The Women sued Bayer Corporation and related entities—the alleged manufacturers of Essure. The nine-count complaint alleges liability under the Indiana Product Liability Act, the Uniform Commercial Code, and the Indiana Consumer Sales Act. Certain defendants (collectively, "Bayer") moved for judgment on the pleadings, asserting that (1) the claims are preempted and (2) aspects of the complaint are deficient. The trial court denied the motion. Bayer appeals.¹

[2] We affirm in part, reverse in part, and remand for further proceedings.

Discussion and Decision

Standard of Review

[3] A Trial Rule 12(C) motion "tests the sufficiency of a claim or defense presented in the pleadings[.]" KS & E Sports v. Runnels , 72 N.E.3d 892, 898 (Ind. 2017). "In reviewing a motion under 12(C), a court must ‘base [its] ruling solely on the pleadings’ and ‘accept as true the material facts alleged in the complaint.’ " Bayer Corp. v. Leach , 147 N.E.3d 313, 315 (Ind. 2020) (alteration in original) (quoting KS & E Sports , 72 N.E.3d at 898 ). "A court should grant the motion ‘only when it is clear from the face of the pleadings that the plaintiff cannot in any way succeed under the operative facts and allegations made therein.’ " Id. (quoting Noblesville Redev. Comm'n v. Noblesville Assocs. Ltd. P'shp , 674 N.E.2d 558, 562 (Ind. 1996) ). "[W]e review a 12(C) ruling de novo." KS & E Sports , 72 N.E.3d at 898.

Regulatory Background

[4] The Food and Drug Administration (the "FDA") is a federal agency that enforces the Federal Food, Drug and Cosmetic Act (the "FDCA"), see 21 U.S.C. ch. 9, including the Medical Device Amendments of 1976 (the "MDA"), see Pub. L. No. 94-295, 90 Stat. 539 (codified as amended in scattered sections of 21 U.S.C. ch. 9). In passing the MDA, Congress established a "rigorous regime" of pre-market approval ("PMA") for Class III medical devices. Riegel v. Medtronic, Inc. , 552 U.S. 312, 317, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). The Women allege that Essure is a Class III medical device that went through the PMA process.

[5] To obtain PMA, a device manufacturer must submit a detailed application. See 21 U.S.C. § 360e(c). The FDA grants PMA if it finds " ‘reasonable assurance’ of the device's ‘safety and effectiveness.’ " Riegel , 552 U.S. at 318, 128 S.Ct. 999 (quoting 21 U.S.C. § 360e(d)(1)(A) ). In making, selling, and distributing a device, the manufacturer must comply with all applicable federal requirements. See 21 U.S.C. §§ 351(h), 352(q). There are generally applicable requirements, including manufacturing standards. See, e.g. , 21 U.S.C. § 360j(f)(1)(A) ; 21 C.F.R. part 820. Moreover, the FDA may impose device-specific requirements as a condition to PMA—for example, the FDA could require warnings on the label. See 21 U.S.C. § 360e(d)(1)(B)(ii) ; 21 U.S.C. § 360j(e). If a manufacturer violates a generally applicable requirement, the device is deemed either adulterated or misbranded (depending on which requirement was violated). See 21 U.S.C. §§ 351, 352. Further, if a manufacturer violates a device-specific requirement, the device is deemed misbranded. See 21 U.S.C. § 352(q). Federal law prohibits selling adulterated or misbranded devices. 21 U.S.C. § 331(a).

[6] Notably, although PMA results in a series of federal requirements, the FDCA itself provides no mechanism for private litigants to sue for non-compliance. Indeed, the FDCA specifies that enforcement proceedings "shall be by and in the name of the United States." 21 U.S.C. § 337(a). Thus, although the federal government regulates medical devices, where—as here—a private litigant alleges injury from a device, the plaintiff must look to state law for a remedy. As to state law, there is a "historic primacy of state regulation of matters of health and safety." Medtronic, Inc. v. Lohr , 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). However, because of the Supremacy Clause in Article VI of the U.S. Constitution, courts "must not give effect to state laws that conflict with federal laws." Armstrong v. Exceptional Child Ctr., Inc. , 575 U.S. 320, 324, 135 S.Ct. 1378, 191 L.Ed.2d 471 (2015). Put differently, where state law conflicts with federal law, state law is preempted. See id.

Express Preemption

[7] One type of preemption is express preemption—where Congress has included "explicit preemptive text[.]" State v. Norfolk S. Ry. Co. , 107 N.E.3d 468, 471 (Ind. 2018). When legislation contains such text, courts "do not invoke any presumption against pre-emption but instead ‘focus on the plain wording of the [text], which necessarily contains the best evidence of Congress' pre-emptive intent.’ " Puerto Rico v. Franklin Cal. Tax-Free Tr. , ––– U.S. ––––, 136 S. Ct. 1938, 1946, 195 L.Ed.2d 298 (2016) (quoting Chamber of Commerce of U.S. v. Whiting , 563 U.S. 582, 594, 131 S.Ct. 1968, 179 L.Ed.2d 1031 (2011) ); see also Norfolk S. Ry. Co. , 107 N.E.3d at 474 (applying no presumption and concluding that a claim was expressly preempted based on the preemptive text).

[8] In the MDA, Congress included the following explicit preemptive text:

[N]o State or political subdivision of a 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) (emphasis added).² With this preemptive text, Congress established a uniform regulatory scheme. See id. That is, because different or additional state-law requirements are expressly preempted, manufacturers face only one standard of care—the federal standard of care. See id. In other words, Congress established both a regulatory floor and a regulatory ceiling. Through this centralized scheme, Congress prevented states from imposing burdensome regulations that could impede innovation or drive beneficial devices off the market. See Riegel , 552 U.S. at 326, 128 S.Ct. 999 (noting that the preemptive text suggests "the solicitude for those injured by FDA-approved devices ... was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States").

[9] For example, if the FDA requires monthly reporting and a state requires weekly reporting, the state law is unenforceable because it is expressly preempted. Cf. Riegel , 552 U.S. at 330, 128 S.Ct. 999 (noting that the explicit preemptive text precludes claims asserting a violation of state tort law "notwithstanding compliance with the relevant federal requirements"). It follows that a litigant could not predicate a claim on failing to make weekly reports; recovering would be tantamount to enforcing a requirement not found in federal law. See 21 U.S.C. § 360k(a).

[10] Thus, due to the explicit preemptive text in the MDA, federal law supplies all germane standards of care. A state may provide a cause of action. However, any viable state-law claim must be premised on the violation of federal law. Therefore, enforceable state requirements—i.e. , standards of care—must parallel federal requirements. See Riegel , 552 U.S. at 330, 128 S.Ct. 999 (recognizing the viability of parallel claims); McGookin v. Guidant Corp. , 942 N.E.2d 831, 838 (Ind. Ct. App. 2011) ("The MDA and Riegel could not be clearer that federal law broadly preempts any claim that would allow a jury to impose a standard of care different from or in addition to the FDA's specific federal requirements."); Bausch v. Stryker Corp. , 630 F.3d 546, 552 (7th Cir. 2010) (noting that where state and federal requirements are effectively the same, the state requirements are not expressly preempted).

Implied Preemption

[11] Even if a claim is not expressly preempted, however, the claim could be impliedly preempted. See Norfolk , 107 N.E.3d at 471. There are two types of implied preemption—field preemption and conflict preemption. Id.

Field Preemption

[12] Field preemption applies where Congress intended to exclusively occupy the field. Id. Here, the preemptive text leaves room for state-law claims premised on the violation of federal law. See 21 U.S.C. § 360k(a) (prohibiting different or additional state-law requirements). Thus, field preemption does not apply.

Conflict Preemption

[13] "Conflict preemption applies when it is ‘physically impossible’ to comply with both the state and federal laws" or "when state law does ‘major damage’ to the federal law's purpose." KS & E Sports , 72 N.E.3d at 905 (quoting Kennedy Tank & Mfg. Co., Inc. v. Emmert Indus. Corp. , 67 N.E.3d 1025, 1029 (Ind. 2017) ). The existence of preemptive text does not bar the "ordinary working" of conflict-preemption principles. Geier v. Am. Honda Motor Co. , 529 U.S. 861, 869, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000).

[14] In Buckman Co. v. Plaintiffs' Legal Comm. , 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), the United States Supreme Court considered whether principles of conflict preemption precluded claims that a device manufacturer defrauded the FDA....