WARREN et al v. BOEHRING INGELHEIM INTERNATIONAL GmbH et al
ORDER granting in part and denying in part 20 Motion to Dismiss for Failure to State a Claim; granting 22 Motion to Dismiss for Failure to State a Claim - The Manufacturers' motion is GRANTED as to Counts (III) negligence, (IV) negligen t misrepresentation, (V) breach of implied warranty of merchantability, (VII) fraudulent misrepresentation, (VIII) fraudulent concealment, (IX) deceptive acts under Indiana's Deceptive Consumer Sales Act, and (XI) punitive damages. Those clai ms are DISMISSED WITH PREJUDICE. The Manufacturers' motion is GRANTED as to Count (VI) breach of express warranty. That claim is DISMISSED WITHOUT PREJUDICE. The Warrens may seek leave to replead the claim within fourteen days from the date of this Order. The Manufacturers' motion is DENIED as to Counts (I) defective design and (II) failure to warn, and derivatively as to Count (X) loss of consortium. Lilly's motion is GRANTED as to Counts (I) defective design and (II) failure to warn. Those claims as to Lilly are DISMISSED WITH PREJUDICE. ***SEE ORDER*** Signed by Judge Sarah Evans Barker on 9/8/2017. (LDH)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
ELI LILLY AND COMPANY,
LILLY USA, LLC,
Spouses 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”).
Before 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 (“Lilly’s motion”).
The Manufacturers’ motion is granted in part and denied in part. Lilly’s separate
dismissal motion is granted in its entirety.
Factual and Procedural History
Taken 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.
Jardiance 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.
After Jardiance’s release to market, 1 the United States Food and Drug
Administration (FDA) received reports that some of its users experienced diabetic
The Warrens do not allege a date when Jardiance was released.
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).
Tanya 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.
The 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.
The 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.
“A 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
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.).
Where, 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 requires.”).
Analysis and Decision
We turn 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.
I. Choice of Law
A 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).
The 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.
Accordingly, 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
II. The Warrens’ Claims Under Louisiana Law
In 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.
The 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. 1617753, 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).
The 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.
The 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).
The 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 below.
Under 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
Stahl, 283 F.3d at 261.
A product may be found unreasonably dangerous in only four respects: in
construction or composition; 2 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.
The 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
“[A] product is unreasonably dangerous in construction or composition if, at the time the
product left its manufacturer’s control, the product deviated in a material way from the
manufacturer’s specifications or performance standards for the product or from otherwise
identical products manufactured by the same manufacturer.” Reynolds, 172 So. 3d at 613 (citing
La. Stat. Ann. § 9:2800.55). The Warrens have not pleaded a freestanding claim for defective
construction. The Manufacturers point out that, under Count (I) defective design, the Warrens
allege in conclusory fashion that the Manufacturers “manufactured . . . Jardiance . . . in a
defective and unreasonably dangerous condition,” Pls.’ Am. Compl. ¶ 58, and the Warrens
fleetingly argue that their complaint “support[s] a reasonable inference that [Jardiance] was . . .
improperly constructed or composed.” Pls.’ Resp. Br., p. 6. We disagree. Outside the abovequoted Paragraph 58, no allegation, conclusory or otherwise, appears in the complaint as might
raise and support a defective construction claim. To the extent the Warrens have attempted to
raise a defective construction claim, it is insufficiently pleaded and hereby dismissed without
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.
We examine next each ground of unreasonable danger asserted and its causal
relationship to the Warrens’ injuries.
A. Count (I): Defective Design
The Warrens plead first that Jardiance is unreasonably dangerous in design. Under
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
(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 such alternative
design on the utility of the product.
Reynolds, 172 So. 3d at 614 (quoting La. Stat. Ann. § 9:2800.56).
The Manufacturers argue that the Warrens failed to plead, as required, “a specific
alternative design . . . .” Defs.’ Br. Supp., p. 10; see Theriot v. Danek Medical, Inc., 168
F.3d 253, 255–56 (5th Cir. 1999) (affirming summary judgment for defendant under
LPLA where plaintiff did not present evidence of alternative design); Reynolds, 172 So.
3d at 614 (affirming summary judgment for defendant where “plaintiff proposed no other
design for the product” and “admitted that he did not develop an alternative design”). The
Manufacturers argue further that the Warrens have not sufficiently pleaded that the riskutility balance would weigh in their favor, Defs’ Br. Supp., p. 12, nor a specific causal
relationship between the alleged defects and Tanya’s injuries. Id. at 12–13.
If put to their proof, the Warrens will be required to show the existence, not
merely of alternative therapies for diabetes, but of an alternative design for Jardiance. See
Theriot, 168 F.3d at 255. Thus, even if proved, the Warrens’ allegation that there are
“several alternative safer methods for treating diabetes [than Jardiance], including diet
and exercise and other anti-diabetic agents[,]” Pls.’ Am. Compl. ¶ 44, will not entitle
them to relief. The question before us, however, is not whether the Warrens have alleged
a prima facie case, but whether the Warrens have “‘raise[d] a reasonable expectation that
discovery will reveal evidence’ to support liability for the wrongdoing alleged.” Adams,
742 F.3d at 729 (quoting Twombly, 550 U.S. at 556). 3
The Warrens allege that “adverse event reporting” shows “an increased rate of
reports for ketoacidosis in people taking Jardiance compared to other glucose-lowering
medications.” Pls.’ Am. Compl. ¶ 35(j). The Warrens allege further that Jardiance is
particularly unsuitable for a class of patients “whose ketones increase,” id. at ¶ 64; see
We note that, except for general pleading principles as set out under “Legal Standard” above,
both parties rely entirely or nearly so on Fifth Circuit authority for their plausibility arguments.
While courts within the Fifth Circuit are more accustomed to applying the LPLA than courts
within the Seventh Circuit, our court nevertheless is bound by Seventh, not Fifth, Circuit
also id. at ¶ 35(b), (f); that Jardiance-induced ketoacidosis “may lead to delayed
treatment because in many cases Jardiance will keep blood sugar below 250 mg/dl, a
threshold often used when diagnosing diabetic ketoacidosis[,]” id. at ¶ 37; and that
“SGLT2 inhibitors . . . have varying selectivity for [the SGLT2] receptor, and block other
sodium-glucose cotransporter receptors, including SGLT1.” Id. at ¶ 24; see also id. at ¶
35(a), (c). The Warrens allege finally that “[t]here were practical and technically feasible
alternative[s]” available to the Manufacturers, “including . . . developing a[n] SGLT2
inhibitor with a different safety profile[,]” that would not have “reduced the utility of
Jardiance” or “cost substantially more to develop[.]” Id. at ¶ 63.
The Warrens have alleged, or raised reasonable inferences of, respects in which
Jardiance is plausibly defective: by increasing the risk of ketoacidosis as compared to
other drugs of its class; by particularly increasing the risk of ketoacidosis in a population
vulnerable to “ketone increase,” id. ¶ 64; by keeping blood glucose beneath a certain
diagnostic threshold, tending to increase the harm of ketoacidosis when it occurs; and by
selecting for the SGLT2 receptor with lower accuracy than other SGLT2 inhibitors. The
Warrens allege that Jardiance could be freed of these defects while still remaining a
viable, cost-effective SGLT2 inhibitor or other glucose-lowering medication. These
allegations are sufficient to withstand dismissal. See Garner v. Boehringer Ingelheim
Pharms., Inc., 888 F. Supp. 2d 911, 924–25 (S.D. Ill. 2012) (denying motion to dismiss
under Illinois law where plaintiff alleged drug’s increased risk of harm as against others
in class, increased difficulty of diagnosis of harm, and increased danger to specific
population of patients). Rule 8 does not require that the Warrens come to court armed
with pharmacologically rigorous design specifications or accounts of mechanisms of
action. “[A] plaintiff’s pleading burden should be commensurate with the amount of
information available to them.” Bausch v. Stryker Corp., 630 F.3d 546, 561 (7th Cir.
2010) (quoting In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d
1200, 1212 (8th Cir. 2010) (Melloy, J., dissenting)).
The Warrens’ allegations would be stronger and clearer, however, if they included
a personalized causal connection between the above-recited allegations and Tanya’s
ketoacidosis: for example, that diagnosis of Tanya’s ketoacidosis was unusually delayed,
or that Tanya is particularly vulnerable to “ketone increase[.]” Pls.’ Am. Compl. ¶ 64.
But that deficiency is not fatal to their complaint. Bausch, 630 F.3d at 560 (“Although the
complaint would be stronger [by specifying the “precise defect” alleged in a medical
device], we do not believe the absence of those details . . . can support a dismissal [with
prejudice] under Rule 12(b)(6).”); Garner, 888 F. Supp. 2d at 923–24 (plaintiff’s alleged
injury plus plausible allegations of product defect sufficient to withstand dismissal even
in absence of allegations specifically linking alleged defects to injury suffered). “We give
the plaintiff ‘the benefit of imagination, so long as the hypotheses are consistent with the
complaint.’” James v. Diva Int’l, Inc., 803 F. Supp. 2d 945, 948 (S.D. Ind. 2011)
(emphasis omitted) (quoting Bausch, 630 F.3d at 559). The core of the Warrens’
allegations is that Jardiance carries with it a higher risk of ketoacidosis—which Tanya
alleges to have experienced—as compared to other SGLT2 inhibitors or other kinds of
While the Manufacturers correctly point out that, under the LPLA, a trier of fact
cannot “infer the existence of a defect based solely on the fact that an accident
occurred[,]” Ashley, 666 So. 2d at 1322 (finding insufficient evidence to sustain judgment
for plaintiffs after bench trial), “circumstantial evidence may be sufficient” to prove a
defect under the LPLA. Jurls v. Ford Motor Co., 32,125 (La. App. 2 Cir. 1/6/2000); 752
So. 2d 260, 266 (reversing directed verdict for defendants, distinguishing Ashley, noting
LPLA imposes liability for “a characteristic” not “a ‘specific’ characteristic”). And the
question for the Court is not whether the Warrens have alleged facts sufficient to sustain
a jury verdict, but whether they have alleged facts sufficient to sustain a plausible claim
Accordingly, we hold that the Warrens’ complaint plausibly states a claim for
Count (I) defective design. Whether dismissal is nevertheless warranted on pre-emption
grounds is considered below.
B. Count (II): Failure to Warn
The Warrens next plead that Jardiance is unreasonably dangerous in failing to
provide an adequate warning. Under the LPLA,
A product is unreasonably dangerous because an adequate
warning about the product has not been provided if . . . the
product possessed a characteristic that may cause damage and
the manufacturer failed to use reasonable care to provide an
adequate warning of such characteristic and its danger to
users . . . of the product.
Reynolds, 172 So. 3d at 614 (quoting La. Stat. Ann. § 9:2800.57(A)).
“Adequate warning” is defined as “a warning or instruction
that would lead an ordinary reasonable user . . . of a product
to contemplate the danger in using . . . the product and either
to decline to use . . . the product or, if possible, to use . . . the
product in such a manner as to avoid the damage for which
the claim is made.
Id. (quoting La. Stat. Ann. § 9:2800.53(9)).
Here, as noted above, the Warrens allege that Jardiance causes damage by causing
ketoacidosis. The Warrens allege further that the Manufacturers with reasonable care
should have known and warned of such danger. Specifically, the Warrens allege that
proper analysis demonstrated or would have demonstrated that Jardiance causes increased
ketones in animals, Pls.’ Am. Compl. ¶ 35(b), and in humans, id. at (f), and that drugs
like Jardiance with selectivity for the SGLT1 receptor may cause ketoacidosis. Id. at (a),
(c). The Warrens allege the Manufacturers nevertheless failed to warn users of Jardiance
and their doctors of the risks of ketoacidosis even when requested by the FDA to do so.
Id. at ¶¶ 39–41, 131(a), (b). Moreover, the Warrens allege that, if Tanya and her
endocrinologist had known of Jardiance’s risks, Tanya “would not have been prescribed
Jardiance, and . . . would not have taken Jardiance, or [Tanya] would have been
adequately monitored for its side effects . . . .” Id. at ¶ 52.
The Warrens’ complaint thus plausibly states a claim for Count (II) failure to
warn. The Manufacturers’ motion is therefore DENIED as to that claim. Again, whether
dismissal as to Lilly is nevertheless warranted on pre-emption grounds is considered
C. Count (VI): Breach of Express Warranty
The Warrens plead finally that Jardiance is unreasonably dangerous in failing to
conform to an express warranty of the manufacturer. Under the LPLA,
A product is unreasonably dangerous when it does not
conform to an express warranty made at any time by the
manufacturer about the product if the express warranty has
induced the [plaintiff] or another person . . . to use the product
and the [plaintiff’s] damage was proximately caused because
the express warranty was untrue.
Reynolds, 172 So. 3d at 615 (quoting La. Stat. Ann. § 9:2800.58). The plaintiff therefore
must allege and ultimately prove: “(1) a specific express warranty that induced [her] to
use [the product], (2) . . . that the warranty was untrue, and (3) . . . that the failure to
conform to that express warranty caused [her] injuries.” Id.
“The LPLA makes it very clear that in order for the manufacturer to be liable,
there must be a specified stated warranty, i.e., express.” Id. (original emphasis)
(distinguishing express warranty from “general . . . expectation” that car’s air bags
would mitigate injury).
[T]he LPLA defines “express warranty” as . . . a
representation, statement of alleged fact or promise about a
product or its nature, material or workmanship that
represents, affirms or promises that the product or its nature,
material or workmanship possesses specified characteristics
or qualities or will meet a specified level of performance.
“Express warranty” does not mean a general opinion about or
general praise of a product. A sample or model of a product is
an express warranty.
Sudderth v. Mariner Elec. Co., Inc., 16-5 (La. App. 5 Cir. 5/26/16); 193 So. 3d 552, 561
(quoting La. Stat. Ann. § 9:2800.53(6)). “An express warranty is a guarantee which the
manufacturer . . . of a good voluntarily undertakes and extends to its customer. It is not a
warning[.]” Hopkins v. Am. Cyanamid Co., 95-1088 (La. 1/16/96); 666 So. 2d 615, 623;
see also Hopkins v. Am. Cyanamid Co., 26,721 (La. App. 2 Cir. 4/8/96); 674 So. 2d 1042,
1044 (distinguishing express warranty from failure to warn); Florence v. Clinique Labs.,
Inc., 347 So. 2d 1232, 1236 (La. Ct. App. 1977) (distinguishing express warranty from
statements “in the nature of a sales pitch arising in the ordinary course of
The Warrens have not pleaded the existence of an express warranty. The Warrens
instead refer generally to the Manufacturers’ “package inserts, marketing, and other
written materials intended for physicians and the public . . . ,” Pls.’ Am. Compl. ¶ 119, as
the source of the alleged warranty, but allege only that those materials either represented
that Jardiance is “safe, effective, fit and proper for its intended use,” id., or omitted
“language that would suggest Jardiance has been associated with diabetic ketoacidosis . .
. .” Id. at ¶ 121. Even if the Manufacturers’ materials—which the Warrens have not
attached to their complaint or directly quoted—expressly state that Jardiance was “safe”
and the like, that does not rise from a “general opinion” to a “representation, statement of
alleged fact or promise” about Jardiance. La. Stat. Ann. § 9:2800.53(6); see Florence,
347 So. 2d at 1236 (cosmetics purporting to be “just the products for you” do not state
actionable warranty). And any claim predicated on the Manufacturers’ omitting to
communicate the risks of ketoacidosis states a failure-to-warn claim, not a breach-ofwarranty claim.
We conclude that the Warrens’ complaint does not plausibly state a claim for
Count (VI) breach of express warranty. The Manufacturers’ motion is therefore
GRANTED as to that claim and it is DISMISSED WITHOUT PREJUDICE.
The Manufacturers’ motion seeks to dismiss Count (I), the defective-design claim,
as pre-empted by the Federal Food, Drug, and Cosmetic Act (FDCA) and FDA
regulations. Lilly moves to dismiss both Counts (I) defective design and (II) failure to
warn as pre-empted by the same law but for a different reason. To avoid “unnecessary
constitutional adjudication,” federal courts “are supposed to explore all nonconstitutional
grounds of decision first[.]” Ameritech Corp. v. McCann, 403 F.3d 908, 911 (7th Cir.
2005). Having determined that Count (I) defective design satisfies Rule 8 as pleaded, we
shall next address the Manufacturers’ motion, and because Count (I) and Count (II)
failure to warn satisfy Rule 8 as pleaded, we shall then address Lilly’s motion.
Pre-emption is an affirmative defense that ordinarily should be raised in a
responsive pleading, not in a motion to dismiss. Bausch, 630 F.3d at 561. Nonetheless,
we shall address this issue now because “[w]hether a particular ground for opposing a
claim may be the basis for dismissal for failure to state a claim depends on whether the
allegations in the complaint suffice to establish that ground, not on the nature of the
ground in the abstract.” Jones v. Bock, 549 U.S. 199, 215 (2007). The Manufacturers’ and
Lilly’s arguments are confined to the allegations as they are set out in the Warrens’
complaint, which “need not anticipate or attempt to circumvent affirmative defenses.”
Bausch, 630 F.3d at 561.
Under the Supremacy Clause of the Constitution, U.S. Const., Art. VI, cl. 2, when
state and federal law conflict, state law is pre-empted and must yield. PLIVA, Inc. v.
Mensing, 564 U.S. 604, 617 (2011). State and federal law conflict “where it is impossible
for a private party to comply with both state and federal law” (“impossibility preemption”) or where “state law stands as an obstacle to the accomplishment and execution
of the full purposes and objectives of Congress” (“obstacle pre-emption”). Crosby v.
Nat’l Foreign Trade Council, 530 U.S. 363, 372–73 (2000) (alteration and quotations
omitted). The Manufacturers rely largely, and Lilly entirely, on impossibility preemption. The Manufacturers mention obstacle pre-emption in passing as well. Both
motions invoke the Supreme Court decisions in Wyeth v. Levine, 555 U.S. 555 (2009),
Mensing, and Mutual Pharmaceutical Company, Inc. v. Bartlett, 133 S. Ct. 2466 (2013),
which considered the pre-emptive effect of the FDCA and FDA regulations on state tort
law as applied to drug manufacturers, and control our decision here.
In Levine, plaintiffs brought a failure-to-warn claim against the manufacturer of a
brand-name drug, contending that state tort law imposed a duty on the manufacturer to
strengthen the drug’s warning label. 555 U.S. at 560. The manufacturer responded that it
was prohibited by the FDCA and FDA from using any label other than the one already
approved by the FDA. Id. at 561. The Supreme Court found, however, that a
manufacturer may strengthen its labels without prior FDA approval under the “changes
being effected” (“CBE”) regulation. Id. at 568. “[A]bsent clear evidence that the FDA
would not have approved a change to [the drug’s] label” made under the CBE regulation,
no impossibility finding between state and federal duties arose. Id. at 571.
Mensing and Bartlett involved suits against manufacturers of generic drugs, which
are subject to a “meaningfully different” federal regulatory framework than applies to
brand-name drugs, Mensing, 564 U.S. at 626, for failure to warn and defective design,
respectively. Critically, a generic drug is required to have the identical label and design as
its brand-name counterpart. Id. at 613 (label); Bartlett, 133 S. Ct. at 2475 (design).
Because generic drug manufacturers cannot “independently” change the labeling or
design of their drugs, Mensing, 564 U.S. at 620, state-law duties requiring such changes
conflict with the federal “duty of sameness” and are pre-empted. Id. at 616. Responding
to the argument that the manufacturers’ compliance with both duties was possible by
ceasing to sell the drug, the Supreme Court held that, under its precedents, the possibility
of ceasing to act does not defeat impossibility pre-emption. Bartlett, 133 S. Ct. at 2477.
B. The Manufacturers’ Motion
As to impossibility pre-emption, the Manufacturers’ argue that any successful
defective-design claim would impose on them a duty to make changes to Jardiance for
which prior FDA approval would be required. The Manufacturers argue further that,
because they cannot independently change the design of Jardiance, the Warrens’ designdefect claim is pre-empted. We reject this argument, however, because it is contrary to
Levine and misreads Mensing. Because the Manufacturers have not shown clear evidence
that any changes to Jardiance requiring FDA approval would be disapproved by the FDA,
the Manufacturers are not at least at this juncture entitled to dismissal based on
impossibility pre-emption, as we explain more fully below.
Regarding obstacle pre-emption, given that the Manufacturers’ cursory argument
was rejected by Levine, we reject it as well.
1. Impossibility Pre-Emption
The Manufacturer’s motion references a design-defect claim against a brand-name
manufacturer, 4 a configuration not confronted in Levine-Mensing-Bartlett. Levine
involved a failure-to-warn claim against a brand-name manufacturer; Mensing involved a
failure-to-warn claim, and Bartlett, a design-defect claim, both against generic
The District Court for the Eastern District of Louisiana recently ruled that preemption of design-defect claims against brand-name manufacturers “is a new and
undecided issue” in the Fifth Circuit. Guidry v. Janssen Pharms., Inc., 206 F. Supp. 3d
1187, 1204 (E.D. La. 2016) (applying LPLA). So it is in the Seventh Circuit as well.
Indeed, “[t]he Sixth Circuit is [still] the only appellate court that has squarely addressed
the issue presented here.” Id. Accordingly, both Guidry and the parties before our court
rely on the Sixth Circuit’s decision in Yates v. Ortho-McNeil-Janssen Pharmaceuticals,
Inc., 808 F.3d 281 (6th Cir. 2015), though they draw opposite conclusions from its
We have been asked to accept that Jardiance is a brand-name drug based on the briefs, as that
fact does not appear on the face of the Warrens’ complaint. Because claims against a generic
manufacturer would be pre-empted without more, we have assumed, in the Warrens’ favor, that
Jardiance is a brand-name drug.
We are persuaded by the reasoning in Yates, consistent with the Manufacturers’
arguments, that “Levine, Mensing, and Bartlett . . . together stat[e] the same test for
impossibility pre-emption[,]” Yates, 808 F.3d at 296–97, and, contrary to the Warrens’
argument, reject that Bartlett “simply does not apply to brand-name drugs . . . .” Pls.’
Resp. Br., p. 11; see Yates, 808 F.3d at 296 (rejecting “contention that the impossibility
preemption in Mensing and Bartlett is limited to generic drugs”). The unexplained
assertion that the brand-name context is simply different, without accounting for why that
difference should not be understood in light of the three decisions above, is not
persuasive. In Yates, “[b]ecause the federal statutes and regulations for brand-name and
generic drugs are sometimes different, . . . brand-name and generic drugs may face
different impossibility preemption results . . . [,]” the court held. 808 F.3d at 297; see
Mensing, 564 U.S. at 626 (“[D]ifferent federal statutes and regulations may . . . lead to
different pre-emption results.”).
Similarly, Yates and Guidry both distinguish between “pre-approval” claims,
focusing on the Manufacturers’ liability prior to FDA approval of Jardiance, and “postapproval” claims, focusing on their liability after FDA approval was granted. The
Warrens make this distinction here as well. Pls.’ Resp. Br., p. 12 (“[T]he main focus of
Plaintiffs’ claims is on the original design of Jardiance before FDA approval, not
Defendants’ failure to redesign the drug after FDA approval.”). While each kind of claim
may reach a different pre-emption result, both must stand or fall on the same reading of
Levine-Mensing-Bartlett. Compare Yates, 808 F.3d at 297–300 (reaching same result:
both claims pre-empted), with Guidry, 206 F. Supp. 3d at 1206–09 (reaching different
result: post-approval but not pre-approval claim pre-empted).
The Manufacturers’ argument for impossibility pre-emption is attractively simple.
“The question for ‘impossibility’ is whether the private party could independently do
under federal law what state law requires of it.” Mensing, 564 U.S. at 620. “Plaintiffs
allege [under the LPLA] that Defendants should have redesigned Jardiance[,]” but
“[f]ederal law prohibits a drug manufacturer from changing a drug’s formulation without
first obtaining FDA approval . . . .” Defs.’ Br. Supp., p. 19 (original emphasis). The
Manufacturers conclude that the Warrens’ design-defect claim is therefore pre-empted.
More specifically, the Manufacturers read Mensing-Bartlett to stand for two
propositions: First, every successful state-law design-defect claim will impose a change
on the design of drug requiring FDA approval before it is made; second, whenever the
approval of a federal official can be shown to stand between a tortfeasor and the
observance of a state-law tort duty, state law is pre-empted without more. The first
proposition is contrary to Bartlett. The second proposition, its startling breadth
notwithstanding, is contrary to Levine and incorrectly reads Mensing.
As to the first proposition, Yates rejected it as the result of “misplaced” reliance on
a one-sentence dictum in Bartlett. 808 F.3d at 296 (citing Bartlett, 133 S. Ct. at 2471
(“Once a drug—whether generic or brand-name—is approved, the manufacturer is
prohibited from making any major changes to the qualitative or quantitative formulation
of the drug product, including active ingredients, or in the specifications provided in the
approved application.” (quotations and citation omitted))). Bartlett itself demonstrates
why this reliance is misplaced.
Following Bartlett, a court deciding an impossibility pre-emption question
“begin[s] by identifying [the defendant’s] duties under state law.” Bartlett, 133 S. Ct. at
2473. This requires asking whether state tort law imposes any duties at all, see id. at
2473–74 (distinguishing fault-based strict-liability and negligence regimes imposing
duties from no-fault, merely cost-allocating “absolute-liability” regimes not imposing
duties), and what the content is of the duties imposed. See id. at 2474–76 (carefully
delineating duties imposed by New Hampshire tort law); Yates, 808 F.3d at 297–98
(carefully delineating duties imposed by New York tort law). The Manufacturers have
undertaken no such case-specific analysis here, relying instead on the conclusory
statement that they “should have redesigned Jardiance” under any successful designdefect claim under any state’s law, or at least without specific reference to the LPLA.
Defs.’ Br. Supp., p. 19. 5
Still following Bartlett, a court must next identify the defendant’s duties under
applicable federal law. See Bartlett, 133 S. Ct. at 2476; Yates, 808 F.3d at 289–99.
“Before marketing a new drug, the manufacturer must submit a New Drug Application
To the extent that the LPLA imposes liability only for products that are “unreasonably
dangerous . . . at the time the product left the control of its manufacturer[,]” La. Stat. Ann. §
9:2800.54 (emphasis added), and a drug arguably leaves the control of its manufacturer for
purposes of the LPLA when it is approved by the FDA, see Guidry, 206 F. Supp. 3d. at 1207–08,
the Warrens’ post-approval claim may be barred, not by pre-emption, but by the failure of a
state-law duty to attach in the first place. As noted above, to avoid “unnecessary constitutional
adjudication,” federal courts “are supposed to explore all nonconstitutional grounds of decision
first[.]” McCann, 403 F.3d at 911.
[(NDA)] to the FDA, which demonstrates by ‘substantial evidence’ that the medication is
efficacious. 21 U.S.C. 355(d)(5).” Mason v. SmithKline Beecham Corp., 596 F.3d 387,
391 (7th Cir. 2010). After the NDA has been approved, “the applicant must notify” the
FDA of any change to the terms of the NDA “beyond the variations already provided for
in the NDA.” 21 C.F.R. § 314.70(a)(1)(i).
Federal regulation defines three classes of changes: “major changes,” “moderate
changes,” and “minor changes.” Id. at (b), (c), (d). Only major changes require “approval
prior to distribution” of the altered drug. Id. at (b). A major change is
any change in the drug substance, drug product, production
process, quality controls, equipment, or facilities that has a
substantial potential to have an adverse effect on the identity,
strength, quality, purity, or potency of the drug product as
these factors may relate to the safety or effectiveness of the
Id. at (b)(1). Such changes “include, but are not limited to[,] . . . changes in the
qualitative or quantitative formulation of the drug product[.]” Id. at (b)(2)(i).
A moderate change is “any change in the drug substance,” etc., “that has a
moderate potential to have an adverse effect on the identity,” etc., “of the drug product as
these factors may relate to the safety or effectiveness of the drug product.” Id. at (c)(1). A
moderate change generally requires submission to the FDA “at least 30 days prior to
distribution . . . [,]” id. at (c), and if the FDA disapproves the change after distribution has
started, the FDA “may order the manufacturer to cease distribution of the drug product(s)
made with the manufacturing change.” Id. at (c)(7). The procedure for moderate changes
is the “CBE regulation” discussed in Levine. 555 U.S. at 568 (quoting 21 C.F.R. §
314.70(c)(6)(iii)(A), (C)); 21 C.F.R. § 314.70(c)(3) (application for change must be
labeled “Supplement—Changes Being Effected”).
On the basis of what a major change “include[s], but [is] not limited to[,]” 21
C.F.R. § 314.70(b)(2)(i), but without any consideration of the provision that a major
change must have “substantial potential to have an adverse effect . . . relat[ing] to the
safety or effectiveness of the drug product[,]” id. at (b)(1) (emphasis added), Yates
concluded that “reduc[ing] the amount of estrogen [in a birth-control patch] from 0.75
mg/patch to 0.6 mg/patch” would be a major change under the “plain meaning of the
regulation[.]” 808 F.3d at 298. Here again, the Manufacturers have undertaken no such
case-specific analysis. Indeed, because it is not clear precisely what changes the LPLA
would impose on the Manufacturers simply from the face of the Warrens’ complaint,
such analysis may not yet be possible. See Bausch, 630 F.3d at 561 (complaint need not
anticipate affirmative defenses).
In short, “[i]mpossibility pre-emption is a demanding defense.” Levine, 555 U.S.
at 573 (emphasis added). Under the analysis set out in Bartlett, and as applied by Yates,
the Manufacturers must specifically identify which state and federal duties allegedly
conflict. Bartlett did not reach, and the Manufacturers are not entitled to rely on, the
“sweeping conclusion” that every successful state-law design-defect claim will impose a
change on the design of drug requiring FDA approval before it is made. Yates, 808 F.3d
But even assuming the Manufacturers have correctly stated the applicable state
and federal duties, that is, assuming that the Warrens’ successful design-defect claim
under the LPLA would require a major change to Jardiance as defined by federal
regulation, the Manufacturers still must establish the second proposition arising from
Mensing: whenever acts required for observance of a state-law duty require the approval
of a federal official, state law is pre-empted without more. 6 There are statements in
Mensing which, taken in isolation, lend support to this general proposition. 564 U.S. at
620 (“The question for ‘impossibility’ is whether the private party could independently
do under federal law what state law requires of it.” (emphasis added)), 623–24 (“[W]hen
a party cannot satisfy its state duties without the Federal Government’s special
permission and assistance, which is dependent on the exercise of judgment by a federal
agency, that party cannot independently satisfy those state duties for pre-emption
purposes.” (emphasis added)).
Contrary to the position taken by the Warrens and the Guidry court, we find no meaningful
distinction between pre-approval claims and post-approval claims in this respect. Pls.’ Resp. Br.,
p. 11–13; Guidry, 206 F. Supp. 3d at 1209. The Warrens correctly point out that there is of
course no federal duty to market unreasonably dangerous drugs. Pls.’ Resp. Br., p. 12. But they
omit the clear federal duty not to market any drug without FDA approval. 21 U.S.C. § 355(a)
(“No person shall introduce . . . into interstate commerce any new drug, unless an approval of an
[NDA] . . . is effective with respect to such drug.”). Thus, if post-approval claims are pre-empted
without more because observance of state law at some stage requires federal approval, so too
must pre-approval claims be.
The Manufacturers could have chosen never to market Jardiance in the first place, but we
agree with the Yates court that this “never start selling” argument is indistinguishable from the
“stop selling” argument squarely rejected in Mensing and again in Bartlett. Yates, 808 F.3d at
300. If “the mere fact that a manufacturer may avoid liability by leaving the market does not
defeat a claim of impossibility[,]” Bartlett, 133 S. Ct. at 2478 n.5, the Court cannot perceive, nor
have the Warrens shown, why the mere fact that a manufacturer may avoid liability by never
entering the market should lead to a different result. Accepting either proposition would “render
impossibility pre-emption ‘all but meaningless’” on the same terms. Id. at 2477 n.3 (quoting
Mensing, 564 U.S. at 621).
The problem with accepting this general proposition as controlling is that it is
directly contrary to the plain holding of Levine. There, as acknowledged in Mensing, 564
U.S. at 624 n.8, the CBE regulation interposed federal approval between the
manufacturer and the observance of its state-law duty to moderately change its drug by
strengthening its label. Though the CBE regulation permitted the manufacturer to act
first, subject to the FDA’s later approval, it is clear that the mere act of distributing a
moderately changed product subject to later approval, or of making a moderate change
that is later disapproved, would not in itself satisfy a manufacturer’s state-law duty.
Precisely for this reason, Levine permitted the manufacturer to show “clear evidence” that
the FDA would later disapprove the change, only then establishing the impossibility of
dual compliance and the manufacturer’s entitlement to pre-emption. Levine, 555 U.S. at
571. In short, the manufacturer in Levine could not observe its state-law duty without
Mensing could simply have overruled Levine on this point. But Mensing expressly
did not overrule Levine. Mensing, 564 U.S. at 624 (Levine is “not to the contrary.”), id. at
n.8 (Levine’s “analysis is consistent with our holding today.”). Mensing may instead have
limited Levine to the arbitrarily defined subset of pre-emption cases in which federal law
interposes federal approval of an action after the action is taken rather than before. But
the Supreme Court “does not normally . . . so dramatically limit earlier authority sub
silentio.” Shalala v. Ill. Council on Long Term Care, Inc., 529 U.S. 1, 18 (2000). The
apparent conflict between Levine and Mensing disappears, however, if the “general
expressions” in Mensing on which the Manufacturers rely are “taken in connection with
the case in which those expressions are used.” Lilly Indus., Inc. v. Health-Chem Corp.,
974 F. Supp. 702, 706 (S.D. Ind. 1997) (Hamilton, J.) (quoting Cohens v. Virginia, 19
U.S. (6 Wheat.) 264, 399 (1821) (Marshall, J.)).
Mensing first determined that the defendant generic manufacturer could satisfy its
state-law duty to provide a stronger warning neither by making a labeling change under
the CBE procedure nor by direct warnings to physicians via “Dear Doctor” letters
because federal law did not permit a generic manufacturer to do either. 564 U.S. at 616.
The FDA, as amicus for the plaintiffs, argued that the misbranding provision of the
FDCA, 21 U.S.C. § 352(f)(2), required “[g]eneric manufacturers that become aware of
safety problems [to] ask the [FDA] to work toward strengthening the label” in concert
with the brand-name manufacturer, to whose label the generic label is yoked by the
federal “duty of sameness . . . .” Mensing, 564 U.S. at 616. The FDA could then have
“worked with” the brand-name manufacturer to craft a new, adequate label. Id. The Court
assumed without deciding that such a duty to “ask the [FDA] to work toward” existed. Id.
The Court nevertheless rejected the FDA’s and the plaintiffs’ argument that the
possibility of “ask[ing] the FDA for help” defeated pre-emption:
The Manufacturers “freely concede” that they could have
asked the FDA for help. If they had done so, and if the FDA
decided there was sufficient supporting information, and if
the FDA undertook negotiations with the brand-name
manufacturer, and if adequate label changes were decided on
and implemented, then the Manufacturers would have started
a Mouse Trap game that eventually led to [compliance with
state law]. . . .
Accepting [the FDA’s and the plaintiffs’ argument] would
render conflict pre-emption largely meaningless because it
would make most conflicts between state and federal law
illusory. We can often imagine that a third party or the
Federal Government might do something that makes it lawful
for a private party to accomplish under federal law what state
law requires of it. . . . [I]t is certainly possible that, had the
Manufacturers asked the FDA for help, they might have
eventually been able to strengthen their warning label. Of
course, it is also possible that the Manufacturers could have
convinced the FDA to reinterpret its regulations in a manner
that would have opened the CBE process to them. . . . [I]t is
also possible that, by asking, the Manufacturers could have
persuaded to rewrite its generic drug regulations entirely or
talked Congress into amending the [FDCA]. If these
conjectures suffice to [defeat pre-emption] . . . , it is unclear
when, outside of express pre-emption, the Supremacy Clause
would have any force. . . .
To be sure, whether a private party can act sufficiently
independently under federal law to do what state law requires
may sometimes be difficult to determine. But this is not such
a case. Before the Manufacturers could satisfy state law, the
FDA . . . had to undertake a special effort permitting them to
do so. To decide these cases, it is enough to hold that when a
party cannot satisfy its state duties without the Federal
Government’s special permission and assistance, which is
dependent on the exercise of judgment by a federal agency,
that party cannot independently satisfy those state duties for
Id. at 619–21, 623–24 (original emphasis, citations omitted).
Two conclusions flow from the above-quoted passages: First, “independence” for
pre-emption purposes is not a binary switch. The question for pre-emption is whether a
private party can act “sufficiently” independently under federal law to comply with state
law. Id. at 623. Second, Mensing carefully avoided the holding that the Manufacturers
advance here; in fact, that question was simply not before the Court at the time. Mensing
rejected the need for extraordinary or special pleading with a federal agency, private third
parties, and Congress for their co-operation in changing or working around federal law.
See id. at 623 (“special effort”), 623–24 (“special permission and assistance”). Mensing
did not reject, and, it seems to us, carefully avoided rejecting, the need for submitting a
change for the FDA’s approval according to the terms of federal law. In other words,
Mensing rejected as defeating pre-emption, not the possibility of dual compliance within
the terms of federal law, but the possibility of dual compliance outside them.
In this light, the restated question for decision here is whether a major change to a
brand-name drug should be treated under the applicable legal principles like a moderate
change to a brand-name drug or like any change to a generic drug. We favor the former,
for three reasons.
First, the only distinction between the approval of moderate and major changes is
the difference in timing. Major changes require FDA approval before distributing the
changed drug, 21 C.F.R. § 314.70(b), while moderate changes may be distributed first
subject to later approval. Id. at (c). But this difference in itself is simply not relevant to
any pre-emption consideration. As noted above, Levine’s clear-evidence requirement
turns on the assumption that a moderate change later rejected would not satisfy the
manufacturer’s state-law duty. And there is nothing in Levine, Mensing, or Bartlett, nor
in the FDCA or federal regulation, to suggest that moderate changes are presumptively,
rebuttably, or revocably approved, such that moderate change-making is qualitatively
more independent, or less dependent on the FDA, in a legal sense than is major changemaking. The timing difference is only a timing difference.
Second, Levine suggests that clear evidence of FDA rejection was required in part
because the manufacturer was not entitled to rely on the assumption that the FDA would
reject a change that by hypothesis makes the manufacturer’s drug safer. See 555 U.S. at
570 (“[T]he very idea that the FDA would bring an enforcement action against a
manufacturer for strengthening a warning pursuant to the CBE regulation is difficult to
accept—neither [the manufacturer] nor the United States [as amicus for the
manufacturer] has identified a case in which the FDA has done so.”). That is only a
hypothesis: the FDA may balance the risk and utility of a proposed change differently
than did a state tort jury. But a manufacturer should be required to show this to be so.
Third, any pre-emption analysis “must be guided by two cornerstones of . . . preemption jurisprudence”: “the purpose of Congress” read against the “assumption” that,
“in a field which the States have traditionally occupied, . . . the historic police powers of
the States were not be superseded by the Federal Act . . . .” Levine, 555 U.S. at 565
(quotations omitted). 7 Levine found, and neither Mensing nor Bartlett questioned, that, in
crafting the FDCA, “Congress took care to preserve state law” as to suits over drugs by
its inclusion of a savings clause and its failure expressly to pre-empt suits over drugs
while expressly pre-empting suits over medical devices. Id. at 567. Congress’s “silence
on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is
It is true that pre-emption “is inescapable and requires no inquiry into congressional design
where compliance with both federal and state regulations is a physical impossibility for one
engaged in interstate commerce[.]” Fla. Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132,
142–43 (1963). But these cases have moved far beyond the “physical impossibility” standard of
Florida Lime, and the Manufacturers have not argued, nor could they, that dual compliance is
“physical[ly] impossib[le].” Id.
powerful evidence that Congress did not intend FDA oversight to be the exclusive means
of ensuring drug safety and effectiveness.” Id. at 575. Our conclusion here is entirely
consistent with this congressional purpose; the Manufacturers’ position is not. See
Guidry, 206 F. Supp. 3d at 1207 (answering in the negative, “[D]id Congress intend the
FDA to be judge and jury in deciding whether a brand name drug is safe and effective? . .
. Are drug manufacturers shielded from liability if their drug causes harm due to a defect
in design simply because the FDA said the drug was safe?”).
In sum, because the Manufacturers have neither identified the specific state and
federal duties at stake in this case, nor shown clear evidence that, if FDA approval of the
state-mandated change is required, such approval would be withheld, the Manufacturers
are not now entitled to dismissal based on impossibility pre-emption.
2. Obstacle Pre-Emption
The Manufacturers in one terse paragraph have also raised an obstacle preemption defense to any pre-approval claim. Defs.’ Br. Supp., pp. 21–22. We reject this
defense for the same reasons relied upon in Levine as to FDA-approved labels: that, in
general, state tort suits complement, rather than frustrate, the accomplishment of the
FDA’s regulatory goals. See Levine, 555 U.S. at 573 (rejecting manufacturer’s argument
that FDA approval is “both a floor and a ceiling for drug regulation”), 574 (noting
Congress’s refusal to enact express pre-emption provision in FDCA’s 70-year history),
579 (“[T]he FDA long maintained that state law offers an additional, and important, layer
of consumer protection that complements FDA regulation.”). Though “some state-law
claims might well frustrate the achievement of congressional objectives,” id. at 581, the
Manufacturers have not shown in any persuasive fashion that this is one of them. See id.
The Manufacturers’ motion to dismiss is therefore DENIED as to Count (I)
C. Lilly’s Motion
The pre-emption defense raised in Lilly’s motion presents a far easier question.
Lilly argues that, because it does not and has never held the NDA for Jardiance, it is in
the same position as a generic manufacturer. Federal law prohibits any person but the
NDA holder from making changes to a drug; Lilly is not the NDA holder; therefore, like
a generic manufacturer, no matter what specific duties the LPLA might impose on it as to
the design and labeling of Jardiance, Lilly is prohibited by federal law from observing
them and the Warrens’ claims thus are pre-empted. Lilly’s Br. Supp., pp. 9–11.
Regarding the Warrens’ claims for Counts (I) defective design and (II) failure to warn,
we agree with Lilly.
The Warrens’ complaint contains no allegations as to who holds the Jardiance
NDA. On a motion to dismiss, a court ordinarily may not consider matters outside the
pleadings without converting the motion into one for summary judgment with notice to
the litigants and an opportunity to respond. Travel All Over the World, Inc. v. Kingdom of
Saudi Arabia, 73 F.3d 1423, 1430 (7th Cir. 1996). But “[a] court may consider judicially
noticed documents without converting” the motion to dismiss. Menominee Indian Tribe
of Wisconsin v. Thompson, 161 F.3d 449, 456 (7th Cir. 1998). “Judicial notice of . . .
documents contained in the public record and reports of administrative bodies is
As urged by Lilly, we judicially notice the FDA publication Approved Drug
Products with Therapeutic Equivalence Evaluations, or the “Orange Book.” The Orange
Book is a “publically available list of drugs which have been approved [by the FDA] for
safety and effectiveness.” Abbot Labs. v. Zenith Labs., Inc., 934 F. Supp. 925, 927 (N.D.
Ill. 1995); see, e.g., Morris v. Wyeth, Inc., No. 9-854, 2012 WL 601455 (W.D. La. Feb.
23, 2012) (noticing Orange Book entry identifying defendant as “one of the reference
listed drug . . . holders” for certain drug (alterations omitted)). As the “applicant holder”
(that is, the NDA holder) for Jardiance, the Orange Book lists “Boehringer Ingelheim
Pharmaceuticals Inc.” FDA, Approved Drug Products with Therapeutic Equivalence
Evaluations, https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm (search by
“Proprietary Name, Active Ingredient or Application Number,” search “Jardiance”) (last
visited Aug. 24, 2017).
As noted above, “[b]efore marketing a new drug, the manufacturer must submit
a[n] [NDA] to the FDA, which demonstrates by ‘substantial evidence’ that the
medication is efficacious. 21 U.S.C. 355(d)(5).” Mason, 596 F.3d at 391. After the NDA
has been approved, “the applicant must notify” the FDA of any change to the terms of the
NDA “beyond the variations already provided for in the NDA.” 21 C.F.R. §
314.70(a)(1)(i). An “applicant” is “any person who submits an NDA . . . or supplement to
an NDA . . . to obtain FDA approval of a new drug and any person who owns an
approved NDA . . . .” Id. at § 314.3. There is no provision under which a nonapplicant
may submit a change to an approved NDA.
The Sixth Circuit has held that, without an NDA, a manufacturer has “no more
power to change the label” or, by extension, the design of a drug than does a generic
manufacturer. In re Darvocet, Darvon, and Propoxyphene Prods. Liab. Litig., 756 F.3d
917, 940 (6th Cir. 2014). That jibes with our view. Without such power, Lilly cannot
independently comply with any duty under the LPLA to change the design or labeling of
Jardiance. The LPLA is therefore pre-empted with regard to these claims against Lilly.
Accordingly, Lilly’s motion is GRANTED. Because amendment would be futile,
Counts (I) defective design and (II) failure to warn are DISMISSED WITH PREJUDICE
as to Lilly. They survive only against Boehringer.
For the above reasons, the Manufacturers’ motion is GRANTED as to Counts (III)
negligence, (IV) negligent misrepresentation, (V) breach of implied warranty of
merchantability, (VII) fraudulent misrepresentation, (VIII) fraudulent concealment, (IX)
deceptive acts under Indiana’s Deceptive Consumer Sales Act, and (XI) punitive
damages. Those claims are DISMISSED WITH PREJUDICE.
The Manufacturers’ motion is GRANTED as to Count (VI) breach of express
warranty. That claim is DISMISSED WITHOUT PREJUDICE. The Warrens may seek
leave to replead the claim within fourteen days from the date of this Order.
The Manufacturers’ motion is DENIED as to Counts (I) defective design and (II)
failure to warn, and derivatively as to Count (X) loss of consortium.
Lilly’s motion is GRANTED as to Counts (I) defective design and (II) failure to
warn. Those claims as to Lilly are DISMISSED WITH PREJUDICE.
SARAH EVANS BARKER, JUDGE
United States District Court
Southern District of Indiana
Robert Thomas Dassow
HOVDE DASSOW & DEETS LLC
Mary Nold Larimore
ICE MILLER LLP
Nancy Menard Riddle
ICE MILLER LLP
Sally F. Zweig
KATZ KORIN CUNNINGHAM, P.C.
Barry H. Boise
PEPPER HAMILTON LLP
Michael Joseph Edelman
PEPPER HAMILTON LLP
Elizabeth C. Curtin
SIDLEY AUSTIN, LLP
SIDLEY AUSTIN, LLP
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