Bayer Corp. v. Leach, Court of Appeals Case No. 19A-CT-625

• Decision Date: 31 December 2019
• Docket Number: Court of Appeals Case No. 19A-CT-625
• Citation: 139 N.E.3d 1127
• Parties: BAYER CORPORATION, et al., Appellants-Defendants, v. Rene LEACH, et al., Appellees-Plaintiffs.
• Court: Indiana Appellate Court

139 N.E.3d 1127

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 December 31, 2019

Attorneys for Appellants: Mary Nold Larimore, 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 women (collectively, the "Women") claim they were injured by a medical device called Essure. The Women sued Bayer Corporation and other related entities—the alleged manufacturers of Essure. The complaint contains several legal theories, including alleged manufacturing defects. Certain defendants (collectively, "Bayer") sought judgment on the pleadings, asserting (1) aspects of the complaint are deficient and (2) the claims are preempted. The trial court denied the motion. Bayer now appeals.¹

[2] Having identified allegations upon which relief could be granted, we affirm.

Discussion and Decision²

Standard of Review

[3] A Trial Rule 12(C) motion "tests the sufficiency of a claim or defense presented in the pleadings and should be granted ‘only where it is clear from the face of the complaint that under no circumstances could relief be granted.’ " KS&E Sports v. Runnels , 72 N.E.3d 892, 898 (Ind. 2017) (quoting Veolia Water Indianapolis, LLC v. Nat'l Trust Ins. Co. , 3 N.E.3d 1, 5 (Ind. 2014) ). Where, as here, the motion "essentially argues the complaint fails to state a claim upon which relief can be granted, we treat it as a 12(B)(6) motion" and engage in de novo review. Id. Moreover, a complaint states a claim—and, therefore, should not be dismissed—"so long as it states any set of allegations, no matter how unartfully pleaded, upon which the plaintiff could be granted relief." Graves v. Kovacs , 990 N.E.2d 972, 976 (Ind. Ct. App. 2013). Under this standard, dismissal is rarely appropriate. King v. S.B. , 837 N.E.2d 965, 966 (Ind. 2005).

Adequacy of the Complaint

[4] Trial Rule 8(A) provides that "a pleading must contain ... a short and plain statement of the claim showing that the pleader is entitled to relief." This "liberal standard merely requires that a ‘complaint ... put the defendant on notice concerning why it is potentially liable and what it stands to lose.’ " KS&E Sports , 72 N.E.3d at 901 (alteration in original) (quoting Noblesville Redev. Comm'n v. Noblesville Assocs. Ltd. P'ship , 674 N.E.2d 558, 564 (Ind. 1996) ). In this case, Bayer contends that the Women failed to adequately plead their claims of manufacturing defects. Bayer argues that these claims run afoul of Trial Rule 8 because the Women made "only a cursory effort to describe the manufacturing defects" and their allegations are conclusory. Br. of Appellant at 52. Bayer also asserts that the Women described only potential defects and failed to tie any defect to the alleged injuries. As an example, Bayer directs us to an allegation that a "no lead solder could in fact have trace lead in it." App. Vol. III at 198.

[5] The Women list several potential defects. See, e.g. , id. at 54 (alleging "the central axis was not fully adhered to the spring which can cause the [device] to fracture/break apart"). Moreover, the Women allege—plaintiff-by-plaintiff—the emergence of specific symptoms following the implantation of an Essure device. See, e.g. , id. at 88 ("Plaintiff Jones' post-procedure course has been marked by menorrhagia, extreme fatigue, abdominal pain, back pain, joint pain, and various skin rashes."). Under Indiana's liberal notice-pleading standard, we conclude Bayer has sufficient notice of the defect-related claims. Cf. Bausch v. Stryker Corp. , 630 F.3d 546, 558 (7th Cir. 2010) (noting that much of the device-specific manufacturing information is kept confidential by federal law and "[f]ormal discovery is necessary before a plaintiff can fairly be expected to provide a detailed statement of the specific bases for her [defect] claim").³

Preemption

Regulatory Background

[6] 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.

[7] 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 21 U.S.C. § 360j(f)(1)(A) ; 21 C.F.R. part 820. Moreover, the FDA may impose device-specific requirements—for example, the FDA could require warnings on the label. See 21 U.S.C. § 360e(d)(1)(B)(ii). If a medical device is manufactured in violation of applicable federal requirements, the device is deemed adulterated. 21 U.S.C. § 351(h). Further, if a medical device is sold or distributed in violation of its device-specific requirements, the device is deemed misbranded. 21 U.S.C. § 352(q).

[8] 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.

[9] 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). In other words, where state law conflicts with federal law, state law is preempted. See id.

Express Preemption

[10] 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). 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).⁴ 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").

[11] 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).

[12] 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. In other words, 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 , 630 F.3d at 552 (noting that where state and federal requirements are effectively the same, the state requirements are not expressly preempted).

[13] Turning to the instant case, the Women allege that Bayer violated federal manufacturing requirements. Assuming for now...