                                                                           FILED
                                                                       Dec 31 2019, 5:38 am

                                                                           CLERK
                                                                       Indiana Supreme Court
                                                                          Court of Appeals
                                                                            and Tax Court




ATTORNEYS FOR APPELLANTS                                  ATTORNEYS FOR APPELLEES
Mary Nold Larimore                                        Lee C. Christie
Robert A. Jorczak                                         Katherine A. Franke
Ice Miller LLP                                            Cline Farrell Christie Lee & Bell, P.C.
Indianapolis, Indiana                                     Indianapolis, Indiana
Erika L. Maley                                            Gregory J. Bubalo
Christopher A. Eiswerth                                   Katherine A. Dunnington
Sidley Austin LLP                                         Bubalo Law PLC
Washington, DC                                            Louisville, Kentucky



                                            IN THE
    COURT OF APPEALS OF INDIANA

Bayer Corporation, et al.,                                December 31, 2019
Appellants-Defendants,                                    Court of Appeals Case No.
                                                          19A-CT-625
        v.                                                Interlocutory Appeal from the
                                                          Marion Superior Court
Rene Leach, et al.,                                       The Honorable James B. Osborn,
Appellees-Plaintiffs.                                     Judge
                                                          Trial Court Cause No.
                                                          49D14-1803-CT-12218



Bailey, Judge.




Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019                           Page 1 of 14
                                                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 Decision                               2




                                             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



      1
          The trial court certified its interlocutory order, and we accepted jurisdiction. See Ind. Appellate Rule 14(B).
      2
          We held oral argument on December 9, 2019. We thank counsel for their skilled presentations.

      Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019                                   Page 2 of 14
      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


      Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019       Page 3 of 14
      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




      3
       Bayer alleges the Women failed to adequately plead other claims. However, because we conclude that the
      manufacturing-defect claims are viable, we need not address any other legal theory.

      Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019                        Page 4 of 14
      devices. Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (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 (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.




      Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019        Page 5 of 14
[9]    There is a “historic primacy of state regulation of matters of health and safety.”

       Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (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 (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.




       Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019          Page 6 of 14
       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 (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 (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,



       4
         This clause applies unless the FDA grants a specific exception. 21 U.S.C. § 360k(b). Here, there is no
       indication that a specific exception applies.

       Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019                             Page 7 of 14
       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 (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 that Indiana law supplies a

       cause of action, the claim is not expressly preempted because it is premised on a

       failure to comply with federal requirements. Put differently, the state-law claim

       avoids express preemption because it is premised on the breach of a duty that

       the federal government imposed. See Bausch, 630 F.3d at 552 (noting that state-

       law claims “based on violations of federal law are not expressly preempted”); cf.

       McGookin, 942 N.E.2d at 838 (determining claims were expressly preempted

       where the plaintiffs failed to allege a violation of federal law).


                                           Implied Preemption
[14]   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.


       Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019    Page 8 of 14
                                                Field Preemption

[15]   Field preemption applies where Congress intended to exclusively occupy the

       field. Id. Here, the explicit preemptive text leaves room for state-law claims

       premised on the violation of federal law. See 21 U.S.C. § 360k(a) (prohibiting

       only different or additional state-law requirements). Thus, field preemption

       does not apply. See, e.g., Lohr, 518 U.S. at 485 (“[W]e have long presumed that

       Congress does not cavalierly pre-empt state-law causes of action.”).


                                              Conflict Preemption

[16]   “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)).

       Notably, 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 (2000).

[17]   In Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), the U.S. Supreme

       Court considered whether principles of conflict preemption preclude claims that

       a device manufacturer defrauded the FDA. The Court examined congressional

       intent, looking to the statute specifying that proceedings to enforce the FDCA

       “shall be by and in the name of the United States.” 21 U.S.C. § 337(a). From

       the statute, the Court discerned “clear evidence that Congress intended that the

       MDA be enforced exclusively by the Federal Government.” Buckman, 531 U.S.


       Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019    Page 9 of 14
       at 352. The Court then disapproved of claims that “exist solely by virtue of the

       FDCA” while endorsing claims that rely “on traditional state tort law [that] had

       predated the federal enactments.” Id. at 353. The Court determined that,

       where state-law claims exist solely because of the FDCA, allowing the litigation

       “would exert an extraneous pull on the scheme established by Congress.” Id.

       The Court concluded that these types of claims are impliedly preempted. Id.


[18]   Thus, to avoid both express and implied preemption, first, “the plaintiff must be

       suing for conduct that violates the FDCA (or else [the] claim is expressly

       preempted by [the explicit preemptive text]).” In re Medtronic, Inc., Sprint Fidelis

       Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010) (quoting Riley v.

       Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009)). In other words, the

       plaintiff must allege and prove that the defendant violated an applicable

       standard set forth in the FDCA. See 21 U.S.C. § 360k(a). Second, “the plaintiff

       must not be suing [solely] because the conduct [exclusively] violates the FDCA

       (such a claim would be impliedly preempted under Buckman).” Sprint Fidelis

       Leads, 623 F.3d at 1204 (quoting Riley, 625 F. Supp. 2d at 777). Rather,

       because only the United States can enforce the FDCA, state law must have

       recognized an independent duty that now parallels the standard set forth in the

       FDCA. See Buckman, 531 U.S. at 352-53 (interpreting and applying 21 U.S.C. §

       337(a)). In short, the plaintiff’s claim is not preempted when the plaintiff is

       enforcing an independent but parallel duty (1) derived from traditional state tort

       law (2) mirroring a standard imposed by the FDCA. See id.




       Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019      Page 10 of 14
[19]   In this case, the Women’s claim of manufacturing defects is not expressly

       preempted because it is premised on the violation of federal requirements.

       Moreover, the claim is not impliedly preempted so long as it does not exist

       solely by virtue of the FDCA. That is, the claim survives if the Women are

       “relying on traditional state tort law.” Id. at 353.


                                        Manufacturing Defects
[20]   The Indiana Product Liability Act (“IPLA”) “governs all actions that are: (1)

       brought by a user or consumer; against a manufacturer or seller; and (3) for

       physical harm caused by a product; regardless of the substantive legal theory or

       theories upon which the action is brought.” I.C. § 34-20-1-1. Indeed, as our

       supreme court has explained, it is “clear” the legislature intended that the IPLA

       govern “all product liability actions, whether the theory of liability is negligence

       or strict liability in tort.” Stegemoller v. ACandS, Inc., 767 N.E.2d 974, 975 (Ind.

       2002) (quoting Dague v. Piper Aircraft Corp., 418 N.E.2d 207, 212 (1981)); see also

       Vaughn v. Daniels Co. (W. Va.), Inc., 841 N.E.2d 1133, 1144 (Ind. 2006).

       Whether the IPLA governs is a question of law. Stegemoller, 767 N.E.2d at 975.


[21]   A medical device falls within the IPLA definition of a product. See I.C. § 34-6-

       2-114 (defining “product” as “any item or good that is personalty at the time it

       is conveyed by the seller to another party” in a transaction not “wholly or

       predominantly the sale of a service rather than a product”). Moreover, a device

       manufacturer is a manufacturer or seller under the IPLA. See I.C. § 34-6-2-77

       (defining “manufacturer” as “a person or an entity who designs, assembles,


       Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019       Page 11 of 14
       fabricates, produces, constructs, or otherwise prepares a product . . . before the

       sale of the product to a user or consumer”); I.C. § 34-6-2-136 (defining “seller”

       as “a person engaged in the business of selling or leasing a product for resale,

       use, or consumption”). Further, the Women allege they each underwent

       implantation procedures that would make them users or consumers under the

       IPLA. See I.C. § 34-6-2-147 (giving “user” the same meaning as “consumer”);

       I.C. § 34-6-2-29 (defining “consumer” as “any individual who uses or consumes

       the product”). Finally, the Women allege they were injured by Essure devices.


[22]   We conclude that the claim of manufacturing defects is governed by the IPLA.

       As to viable claims, the IPLA imposes liability on a manufacturer who


               puts into the stream of commerce any product in a defective
               condition unreasonably dangerous to any user or
               consumer . . . for physical harm caused by that product to the
               user or consumer . . . if:


                        (1) that user or consumer is in the class of persons that the
                        seller should reasonably foresee as being subject to the
                        harm caused by the defective condition;


                        (2) the seller is engaged in the business of selling the
                        product; and


                        (3) the product is expected to and does reach the user or
                        consumer without substantial alteration in the condition in
                        which the product is sold by the person sought to be held
                        liable under [the IPLA].


       I.C. § 34-20-2-1.

       Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019         Page 12 of 14
[23]   Here, a jury could reasonably conclude that the alleged failure to comply with

       federal manufacturing standards rendered Essure in a defective condition

       unreasonably dangerous to any user or consumer. See I.C. § 34-20-2-1. This

       type of claim is (1) not expressly preempted because it is premised on a

       violation of federal law and (2) not impliedly preempted because it is derived

       from traditional Indiana tort law. Thus, the state-law claim is viable.

[24]   We find support in Bausch. There, the Seventh Circuit addressed whether a

       manufacturing-defect claim was impliedly preempted when it was premised on

       the violation of federal manufacturing requirements—conduct that would result

       in the device being “adulterated” under federal law. Bausch, 630 F.3d at 557.

       The Court determined the claim was not impliedly preempted under Buckman:


               While there may not be a “traditional state tort law” claim for an
               “adulterated” product in so many words, the federal definition of
               adulterated medical devices is tied directly to the duty of
               manufacturers to avoid foreseeable dangers with their products
               by complying with federal law. The evidence showing a
               violation of federal law shows that the device is adulterated and
               goes a long way toward showing that the manufacturer breached
               a duty under state law toward the patient.


       Id.


[25]   We have concluded that the manufacturing-defect claim is viable. Thus, Bayer

       has not demonstrated that the complaint is devoid of allegations upon which

       relief could be granted. See KS&E Sports, 72 N.E.3d at 898. Therefore, Bayer is

       not entitled to dismissal at this early stage of the proceedings.


       Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019      Page 13 of 14
                                               Other Theories
[26]   The Women advance several other legal theories and group their factual

       allegations based upon those theories. Bayer asserts that some of the allegations

       involve conduct that is compliant with federal law, and that legal theories based

       on those allegations would not be viable. However, because a pleading need

       not identify theories, a court need not strike specific theories upon a motion for

       judgment on the pleadings. See Noblesville, 674 N.E.2d at 564 (explaining that

       notice pleading requires adequate factual allegations, but not the specification

       of legal theories); Graves, 990 N.E.2d at 976 (noting that a complaint “is

       sufficient and should not be dismissed so long as it states any set of

       allegations . . . upon which the plaintiff could be granted relief”); cf. Bausch, 630

       F.3d at 559 (“When a complaint asserts claims that are legally valid and those

       that are not, the correct judicial response is not to dismiss the complaint.”).



                                                Conclusion
[27]   The trial court did not err in declining to enter judgment on the pleadings.


[28]   Affirmed.


       Baker, J., and Najam, J., concur.




       Court of Appeals of Indiana | Opinion 19A-CT-625 | December 31, 2019       Page 14 of 14
