Bayer Corporation v. Rene Leach, 147 N.E.3d 313

Background

36 women sued Bayer Corporation and related entities asserting multiple product‑liability and statutory claims arising from a medical device Bayer manufactured.
Plaintiffs alleged defective manufacturing, misleading marketing/promotions, inadequate warnings/labels, negligent physician training, and failures in post‑market reporting/studies.
Bayer moved for judgment on the pleadings under Indiana Trial Rule 12(C), arguing inadequate pleading and that the claims are preempted by the Medical Device Amendments to the FDCA.
The trial court denied Bayer’s motion, certified the order for interlocutory appeal, and the Court of Appeals affirmed as to the manufacturing‑defect claim (finding it pleaded and not preempted) while declining to analyze the other claims.
The Indiana Supreme Court granted transfer, vacated the Court of Appeals opinion, and remanded, holding the Court of Appeals must evaluate the viability of each plead claim under Rule 12(C).
The Court reiterated Indiana’s notice‑pleading standard (T.R. 8) and the Rule 12(C) standard: accept pleaded material facts as true and grant only if plaintiff cannot succeed under any set of operative facts alleged.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether one viable claim in a multi‑claim complaint bars dismissal of other claims on a 12(C) motion	Leach: existence of a viable claim preserves the entire complaint from dismissal	Bayer: each discrete claim must be tested and may be dismissed if unviable	Court: Each claim must be evaluated separately; a single viable claim does not immunize other deficient claims—remand to Court of Appeals to assess all claims
Whether the manufacturing‑defect claim was sufficiently pleaded and preempted by federal law	Leach: manufacturing claim adequately pleaded and not preempted by the MDA	Bayer: manufacturing claim inadequately pleaded and preempted by federal law	COA had held the manufacturing claim viable and not preempted, but Supreme Court vacated COA opinion and remanded for consideration of all claims (did not resolve merits itself)
Scope of Indiana notice pleading (T.R. 8) — must plaintiffs plead precise legal theories?	Leach: operative facts pleaded suffice under notice pleading; precise legal theory not required	Bayer: demanded more detailed, discrete factual allegations for certain theories	Court: Confirms notice pleading requires a short/plain statement of operative facts; precise legal theory is not required though operative facts must be alleged
Standard for deciding a Rule 12(C) motion	Leach: accept pleaded facts; dismissal improper if any conceivable relief under alleged facts	Bayer: pleadings fail to state claims and dismissal appropriate for unviable claims	Court: Reiterates 12(C) standard—decide solely on pleadings, accept material facts, and grant only when plaintiff cannot in any way succeed under the pleaded operative facts

Key Cases Cited

Trail v. Boys & Girls Club of Nw. Indiana, 845 N.E.2d 130 (Ind. 2006) (operative facts required under notice pleading)
State v. Rankin, 294 N.E.2d 604 (Ind. 1973) (precise legal theory not required in pleadings)
Noblesville Redev. Comm’n v. Noblesville Assocs. Ltd. P’ship, 674 N.E.2d 558 (Ind. 1996) (notice pleading informs defendant; discrete claims need discrete factual allegations)
KS&E Sports v. Runnels, 72 N.E.3d 892 (Ind. 2017) (12(C) review may dispose of some claims and preserve others)
Veolia Water Indianapolis, LLC v. Nat’l Trust Ins. Co., 3 N.E.3d 1 (Ind. 2014) (12(C) requires accepting pleaded facts)
Murray v. City of Lawrenceburg, 925 N.E.2d 728 (Ind. 2010) (12(C) dismissal standard)
Bayer Corp. v. Leach, 139 N.E.3d 1127 (Ind. Ct. App. 2019) (Court of Appeals opinion addressing manufacturing‑defect claim)