United States District Court, S.D. Indiana, Indianapolis Division
EVANS BARKER, United States District Court Judge
Tanya and Larry Warren (“Tanya, ” “Larry,
” together, “the Warrens”) brought this
products-liability action based on diversity jurisdiction
against the manufacturers of Jardiance, a drug for treating
diabetes: Boehringer Ingelheim Pharmaceuticals, Inc., and its
parent company Boehringer Ingelheim International GmbH
(“Boehringer”), and Lilly USA, L.L.C., and its
parent company Eli Lilly and Company (“Lilly”)
(together, “the Manufacturers”).
the Court are two motions to dismiss for failure to state a
claim under Federal Rule of Civil Procedure 12(b)(6). The
Manufacturers jointly seek dismissal of all the Warrens'
claims as insufficiently pleaded under Federal Rules of Civil
Procedure 8 and 9, and of one claim as pre-empted by federal
law (“the Manufacturers' motion”). Lilly
separately seeks dismissal of two of the Warrens' claims
as pre-empted by federal law for a reason peculiar to it
Manufacturers' motion is granted in part and denied in
part. Lilly's separate dismissal motion is granted in its
and Procedural History
as true, the Warrens' factual allegations reveal the
following: The Warrens are Louisiana citizens who live in the
town of Olla, Louisiana. Pls.' Am. Compl. ¶¶
9-10. Tanya suffers from type 2 diabetes mellitus,
id. at ¶ 21, for which her endocrinologist
prescribed Jardiance, at a dosage of 10 milligrams taken by
mouth once daily, beginning on or about February 4, 2015.
Id. at ¶¶ 45-46.
is indicated “for the improvement of glycemic control
in adults with type 2 diabetes.” Id. at ¶
26. It belongs to a class of drugs called sodium glucose
cotransporter 2 (SGLT2) inhibitors, id. at ¶
22, the effect of which is to “inhibit renal glucose
reabsorption through the SGLT2 receptor in the proximal renal
tubules, causing glucose to be excreted through the urinary
tract . . . .” Id. at ¶ 23. SGLT2
inhibitors “are designed to target primarily the SGLT2
receptor, but have varying selectivity for this receptor, and
block other sodium-glucose cotransporter receptors, including
SGLT1.” Id. at ¶ 24.
Jardiance's release to market,  the United States Food and
Drug Administration (FDA) received reports that some of its
users experienced diabetic ketoacidosis. Id. at
¶ 30. Ketoacidosis is a “life-threatening”
condition, id. at ¶ 5, that “may lead to
complications such as cerebral edema, pulmonary edema,
cerebrovascular accident, myocardial infarction, nonspecific
myocardial injury, severe dehydration, and coma.”
Id. at ¶ 36. Jardiance may also make
ketoacidosis more difficult to detect “because in many
cases Jardiance will keep blood sugar below 250 mg/dl, a
threshold often used when diagnosing diabetic
ketoacidosis.” Id. at ¶ 37. In December
2015, the FDA requested that the Manufacturers of Jardiance
and the manufacturers of other SGLT2 inhibitors warn their
users about the risks of ketoacidosis. Id. at ¶
32. The Manufacturers apparently declined the FDA's
request. See Id. at ¶¶ 39-41, 131(a), (b).
began taking Jardiance as directed by her endocrinologist.
Id. at ¶ 45. On May 28, 2015, less than four
months after it was prescribed for her, Tanya was
hospitalized for ketoacidosis. Id. at ¶ 47. The
Warrens note that Jardiance and other SGLT2 inhibitors may
also cause kidney and bone problems in their users, e.g.,
Id. at ¶ 23, 31, 34-35, 38-39, 43, 135, but Tanya
does not claim to have suffered such conditions. However, as
a result of ketoacidosis, Tanya, and derivatively Larry,
experienced “pain and suffering, emotional distress,
loss of enjoyment of life, and economic loss[.]”
Id. at ¶ 48.
Warrens brought the instant action in this Court on May 27,
2016. Dkt. 1. In response to our order, Dkt. 4, the Warrens
filed an amended complaint properly setting out their
diversity jurisdiction allegations on June 9, 2016. Dkt. 5.
The amended complaint alleges eleven claims against all the
Manufacturers, whom the Warrens hold jointly responsible for
all aspects of Jardiance's design and marketing.
Pls.' Am. Compl. ¶ 27.
Warrens seek to hold the Manufacturers liable as follows:
Counts (I) defective design; (II) failure to warn; (III)
negligence; (IV) negligent misrepresentation; (V) breach of
implied warranty of merchantability; (VI) breach of express
warranty; (VII) fraudulent misrepresentation; (VIII)
fraudulent concealment; (IX) deceptive acts under
Indiana's Deceptive Consumer Sales Act, Ind. Code ch.
24-5-0.5; (X) Terry's loss of consortium; and (XI)
punitive damages. The Manufacturers moved to dismiss the
amended complaint on September 20, 2016. Dkt. 20. Lilly
separately moved to dismiss two of the claims that same day.
Dkt. 22. Each motion has been fully briefed and is now ripe
for decision. Dkt. 21, 23, 26-28, 30.
pleading that states a claim to relief must contain . . . a
short and plain statement of the claim showing that the
pleader is entitled to relief . . . .” Fed.R.Civ.P.
8(a); Adams v. City of Indianapolis, 742 F.3d 720,
728 (7th Cir. 2014). A motion to dismiss for failure to state
a claim under Federal Rule of Civil Procedure 12(b)(6)
“test[s] the legal sufficiency of a complaint.”
Triad Assocs., Inc. v. Chi. Hous. Auth., 892 F.2d
583, 586 (7th Cir. 1989), abrogated on other grounds by
Bd. of Cty. Comm'rs v. Umbehr, 518 U.S. 668 (1996).
To survive dismissal,
a complaint must “state a claim to relief that is
plausible on its face.” Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 570 (2007). A claim has
“facial plausibility when the plaintiff pleads factual
content that allows the court to draw the reasonable
inference that the defendant is liable for the misconduct
alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678
(2009). . . . We draw all reasonable inferences and facts in
favor of the nonmovant, but need not accept as true any legal
assertions. Vesely v. Armslist LLC, 762 F.3d 661,
664-65 (7th Cir. 2014).
Wagner v. Teva Pharms. USA, Inc., 840 F.3d 355,
357-58 (7th Cir. 2016). This Court has previously noted that,
“[a]lthough Twombly and Iqbal
represent a new gloss on the standards governing the
sufficiency of pleadings, they do not overturn the
fundamental principle of liberality embodied in Rule
8.” DuRocher v. Riddell, Inc., 97 F.Supp.3d
1006, 1013 (S.D. Ind. 2015) (Barker, J.).
as here, the deadline for amending a complaint as of right
has passed, Fed.R.Civ.P. 15(a)(1)(B), further amendment
requires leave of court or the defendants' consent.
Id. at (a)(2). “Although leave to file a
second amended complaint should be granted liberally, a
district court may deny leave for several reasons including .
. . futility of amendment.” Dubicz v. Commonwealth
Edison Co., 377 F.3d 787, 792 (7th Cir. 2004)
(quotations omitted); see Fed. R. Civ. P. 15(a)(2)
(“The court should freely give leave when justice so
first to resolve a choice of law issue. Thereafter, we
address whether the Warrens' complaint satisfies Rule 8,
Fed. R. Civ. P., by advancing plausible claims to relief.
Assuming the allegedly pre-empted claims satisfy Rule 8, we
finally will take up the pre-emption defenses raised jointly
by the Manufacturers and separately by Lilly.
Choice of Law
federal court sitting in diversity applies the whole law of
the state in which it sits, that is, its substantive law
including its choice-of-law rules. Klaxon Co. v. Stentor
Elec. Mfg. Co., 313 U.S. 487, 496 (1941);
Auto-Owners Ins. Co. v. Websolv Computing, Inc., 580
F.3d 543, 547 (7th Cir. 2009). A federal court's task is
to apply the law “as we believe the highest court of
the state would apply it.” Pisciotta v. Old
Nat'l Bancorp, 499 F.3d 629, 634 (7th Cir. 2007).
Manufacturers contend that Indiana courts would apply
Louisiana law in resolving this case. The Warrens tacitly
concede that point by failing to contest it, by defending the
sufficiency of their complaint under Louisiana law, and by
conceding that Louisiana law bars several of their claims.
See Pls.' Resp. Br., pp. 4-9, 9 n. 3. Because a
court “do[es] not worry about conflict of laws unless
the parties disagree on which state's law applies[,
]” Wood v. Mid-Valley, Inc., 942 F.2d 425, 427
(7th Cir. 1991) (distinguishing subject-matter jurisdiction
and federal comity), we shall apply Louisiana law to this
case without further discussion.
the Manufacturers' motion is GRANTED as to the
Warrens' Count (IX) deceptive acts brought under
Indiana's Deceptive Consumer Sales Act, Ind. Code ch.
24-5-0.5. Because amendment would be futile, Count (IX) is
DISMISSED WITH PREJUDICE.
The Warrens' Claims Under Louisiana Law
Louisiana, “the exclusive theories of
liability for manufacturers for damage caused by their
products” are established by the Louisiana Products
Liability Act (LPLA). La. Stat. Ann. § 9:2800.52
(emphasis added); Reynolds v. Bordelon, 2014-2371
(La. 6/30/15); 172 So.3d 607, 612. A plaintiff may not
recover for damage caused by a manufacturer's product
“on the basis of any theory not set forth” in the
LPLA. La. Stat. Ann. § 9:2800.52; Ashley v. Gen.
Motors Corp., 27, 851 (La.App. 2 Cir. 1/24/96); 666
So.2d 1320, 1321-22.
Warrens concede that “the LPLA's exclusivity
provision bars . . . claims beyond [its] scope . . . .”
Pls.' Resp. Br., p. 9 n.3. This concession is well taken.
It reaches Counts (III) negligence, Stahl v. Novartis
Pharms. Corp., 283 F.3d 254, 261 (5th Cir. 2002); (IV)
negligent misrepresentation, Donald v. AstraZeneca
Pharms., L.P., No. 16-17753, 2017 WL 1079186 (E.D. La.
Mar. 22, 2017); (V) breach of implied warranty of
merchantability, Jefferson v. Lead Indus. Ass'n,
Inc., 106 F.3d 1245, 1251 (5th Cir. 1997); (VII)
fraudulent misrepresentation, id.; and (VIII)
fraudulent concealment, Grenier v. Medical Engineering
Corp., 99 F.Supp.2d 759, 763 (W.D. La. 2000). Count (XI)
punitive damages is generally unavailable under Louisiana law
unless expressly authorized by statute, Int'l
Harvester Credit Corp. v. Seale, 518 So.2d 1039, 1041
(La. 1988), and the LPLA contains no such authorization.
See La. Stat. Ann. §§ 2800.51 through .60;
see also, e.g., Bladen v. C.B. Fleet Holding Co.,
487 F.Supp.2d 759, 770 (W.D. La. 2007).
Manufacturers' motion is therefore GRANTED as to each of
these claims. With the dismissal of the fraud claims, the
Manufacturers' Rule 9, Fed. R. Civ. P., arguments are
moot. See Fed. R. Civ. P. 9(b) (fraud pleaded with
particularity); Dkt. 20 (moving to dismiss under Rule 9(b)).
Because amendment would be futile, Counts (III), (IV), (V),
(VII), (VIII), and (XI) are DISMISSED WITH PREJUDICE.
Manufacturers argue further that “the Court should
dismiss all of [the Warrens'] substantive
claims, because [the Warrens] have not brought any of these
claims pursuant to the LPLA.” Defs.' Br. Supp., p.
8 (emphasis added). With this, we disagree. “[A]
plaintiff need not plead legal theories in her complaint[,
]” King v. Kramer, 763 F.3d 635, 642 (7th Cir.
2014), and “specifying an incorrect theory is not a
fatal error.” Rabe v. United Air Lines, Inc.,
636 F.3d 866, 872 (7th Cir. 2011).
question remaining, then, is whether the Warrens have pleaded
sufficient facts to raise a facially plausible claim to
relief under the LPLA. Wagner, 840 F.3d at 358. The
Warrens argue that their four remaining claims are
sufficiently pleaded under the LPLA to survive dismissal:
Counts (I) defective design, (II) failure to warn, (VI)
breach of express warranty, and Terry's derivative claim
for Count (X) loss of consortium. We discuss these claims
the LPLA, the manufacturer of a product is liable for damage
proximately caused “by a characteristic of the product
that renders the product unreasonably dangerous”
arising from “a reasonably anticipated use of the
product” by the plaintiff or another. La. Stat. Ann.
§ 9:2800.54(A); Reynolds, 172 So.3d at 612.
Thus, a plaintiff under the LPLA must prove four elements:
(1) that the defendant is a manufacturer of the product; (2)
that the [plaintiff's] damage was proximately caused by a
characteristic of the product; (3) that this characteristic
made the product “unreasonably dangerous”; and
(4) that the [plaintiff's] damage arose from a reasonably
anticipated use of the product by the product by the
[plaintiff] or someone else.
Stahl, 283 F.3d at 261.
product may be found unreasonably dangerous in only four
respects: in construction or composition; in design; in
failing to provide an adequate warning; and in failing to
conform to an express warranty of the manufacturer. La. Stat.
Ann. § 9:2800.54(B)(1) through (4); Reynolds,
172 So.3d at 612-13. As relevant here, the characteristic
allegedly making the product unreasonably dangerous
“must exist at the time product left the control of its
manufacturer.” La. Stat. Ann. § 9:2800.54(C);
Reynolds, 172 So.3d at 613.
Warrens allege that the Manufacturers manufactured Jardiance,
Pls.' Am. Compl. ¶ 27, and that the Manufacturers
“expected and intended Jardiance to reach, and it did
in fact reach, [Tanya] without any substantial change in the
condition of the product from when it was initially
manufactured . . . .” Id. at ¶ 68.The
Warrens allege further that Jardiance is prescribed for the
treatment of adult type 2 diabetes, id. at ¶
26, that Tanya has type 2 diabetes, id. at ¶
29, and that Tanya was prescribed Jardiance by her
endocrinologist and took it as directed. Id. at
¶ 45. Finally, the Warrens allege that, as a result,
Tanya suffered ketoacidosis and its “severe and life
threatening side effects . . . .” Id. at
¶ 21. These averments plausibly allege that the
Manufacturers are manufacturers of the product, that any
unreasonable danger existed at the time the product left the
Manufacturers' control, and that Tanya's damage arose
from a reasonably anticipated use of the product by her.
examine next each ground of unreasonable danger asserted and
its causal relationship to the Warrens' injuries.
Count (I): Defective Design
Warrens plead first that Jardiance is unreasonably dangerous
in design. Under the LPLA,
A product is unreasonably dangerous in design if, at the time
the product has left its manufacturer's control:
(1) There existed an alternative design for the product that
was capable of preventing the claimant's damage; and
(2) The likelihood that the product's design would cause
the claimant's damage and the gravity of that damage
outweighed the burden on the manufacturer of adopting such
alternative design and the adverse effect, if any, of ...