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
December 31, 2019
Bailey, Judge.
Interlocutory Appeal from the Marion Superior Court, The Honorable James B. Osborn, Judge, Trial Court Cause No. 49D14-1803-CT-12218
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
[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.
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]
[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
[7] To obtain PMA, a device manufacturer must submit a detailed application. See
[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.”
[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.
[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
[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 (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.
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
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.”
[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
[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.
[20] The Indiana Product Liability Act (“IPLA“) “governs all actions that are: (1) brought by a user or consumer; (2) 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.”
[21] A medical device falls within the IPLA definition of a product. See
[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].
[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
[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
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.
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.