Interlocutory Appeal from the Marion Superior Court The
Honorable James B. Osborn, Judge Trial Court Cause No.
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
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.
Having identified allegations upon which relief could be
granted, we affirm.
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).
of the Complaint
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.
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").
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 (2008). The Women
allege that Essure is a Class III medical device that went
through the PMA process.
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).
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.
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 ...