United States District Court, W.D. Tennessee, Eastern Division
ORDER PARTIALLY GRANTING AND PARTIALLY DENYING
DEFENDANT'S MOTION TO DISMISS
THOMAS ANDERSON CHIEF UNITED STATES DISTRICT JUDGE
Melissa Mitchell filed this product liability action under
the Tennessee Product Liability Act (“TPLA”),
Tenn. Code Ann. § 29-28-101 et seq., against
Eli Lilly and Company and Boehringer Ingelheim
Pharmaceuticals, Inc. (“BIPI”), alleging that she
developed diabetic ketoacidosis (“DKA”) after she
began taking Jardiance, a prescription medication approved by
the Food and Drug Administration (“FDA”) as safe
and effective for the treatment of type 2 diabetes. Defendant
BIPI holds the New Drug Application (“NDA”) for
Jardiance and co-markets the product with Eli Lilly and
Company. Jurisdiction is predicated on diversity of
citizenship, 28 U.S.C. § 1332. Defendant BIPI has filed
a motion to dismiss Plaintiff's second amended complaint.
(ECF No. 62.) Plaintiff has filed a response to the motion
(ECF No. 64), and Defendant has filed a reply to the
response. (ECF No. 65.) For the reasons set forth below,
Defendant's motion is PARTIALLY GRANTED
and PARTIALLY DENIED.
motion to dismiss under Federal Rule of Civil Procedure
12(b)(6) tests the legal sufficiency of the complaint.
RMI Titanium Co. v. Westinghouse Elec. Corp., 78
F.3d 1125, 1134 (6th Cir. 1996). Under Federal Rule of Civil
Procedure 8(a)(2), a pleading must contain a “short and
plain statement of the claim showing that the pleader is
entitled to relief.” The Supreme Court clarified the
pleading standard in Bell Atlantic Corporation v.
Twombly, 550 U.S. 555 (2007), and Ashcroft v.
Iqbal, 556 U.S. 662 (2009). Under Twombly, to
survive a motion to dismiss, a complaint need not contain
“detailed factual allegations, ” but it must
contain more than “labels and conclusions” or
“a formulaic recitation of the elements of a cause of
action ...” 550 U.S. at 570. A complaint does not
“suffice if it tenders ‘naked assertions'
devoid of ‘further factual enhancement.'”
Iqbal, 556 U.S. at 678 (quoting Twombly,
550 U.S. at 557). “[A] complaint must contain
sufficient factual matter, accepted as true, to ‘state
a claim to relief that is plausible on its face.'”
Id. (quoting Twombly, 550 U.S. at 570).
“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.” Id. (citing
Twombly, 550 U.S. at 556).
plausibility standard “does not impose a probability
requirement at the pleading stage; it simply calls for enough
facts ‘to raise a reasonable expectation that discovery
will reveal evidence of illegal [conduct].'”
Twombly, 550 U.S. at 556. In deciding whether the
plaintiff has set forth a plausible claim, the Court must
accept the factual allegations in the complaint as true.
Id.; see also Erickson v. Pardus, 551 U.S.
89 (2007). This presumption, however, is not applicable to
legal conclusions. Iqbal, 556 U.S. at 678.
Therefore, “[t]hreadbare recitals of the elements of a
cause of action, supported by mere conclusory statements, do
not suffice.” Id. (citing Twombly,
550 U.S. at 555).
court considering a 12(b)(6) motion may consider materials in
addition to the complaint if such are public records.”
Rodney v. LaHood, 359 F. App'x 634, 637 (6th
Cir. 2010). FDA documents may properly be considered on a
motion to dismiss. See, e.g., Spier v.
Coloplast Corp., 121 F.Supp.3d 809, 811 n. 2 (E.D. Tenn.
2015) (taking judicial notice of “various publicly
available” FDA documents).
second amended complaint (ECF No. 56) alleges that Jardiance
(empagliflozin) was approved by the FDA on August 1, 2014, as
safe and effective for the treatment of type 2 diabetes. (SAC
¶ 15, ECF No. 56.) It is the third member of the newest
class of medications used to treat type 2 diabetes known as
sodium-glucose co-transporter 2 (“SGLT2”)
inhibitors. (Id.) The second amended complaint
further alleges that Plaintiff began taking Jardiance to
treat her diabetes in or about February 2015 and used
Jardiance consistently until June 2, 2015. (Id.
¶¶ 26, 33.)
May 15, 2015, the FDA issued a safety alert covering the
SGLT-2 inhibitor class, warning about the risk of DKA.”
(Id. ¶ 35.) The data on which the May 15, 2015,
safety alert was premised “was collected from March
2013 to June 6, 2014, nearly two months prior to
Jardiance's approval” and came from the FDA Adverse
Event Reporting System (“FAERS”), “a
publicly available database.” (Id.
¶¶ 36-37.) “As part of its continued
evaluation, on December 4, 2015[, ] the FDA issued a new
safety communication disclosing they had found 73 adverse
events reported between March 2013 and May 2015 that required
hospitalization due to ketoacidosis related to SGLT-2
inhibitors.” (Id. ¶ 38.)
contends that Defendant BIPI “did not warn about the
risks of DKA” at the time “JARDIANCE was
approved” (id. ¶ 53) and did not
“amend the label or utilize the [FDA's Changes
Being Effected (‘CBE')] process” to warn
about the risks of DKA before Plaintiff used the medication
(id. ¶ 68(c)). She alleges that she was injured
as a result of taking the drug without being warned of the
possible risks. In addition to developing DKA, Plaintiff
alleges that she experienced “other related health
complications.” (Id. ¶¶ 90, 114.)
to Plaintiff, Jardiance's warnings were defective and/or
unreasonably dangerous with regard to the increased risk of
exposure to DKA because there were no warnings for DKA at any
time prior to Plaintiff's alleged injury on June 2, 2015,
and no DKA warning at any time prior to the December 4, 2015,
label change. (Id. ¶¶ 54-56.)
contends that Plaintiff's failure-to-warn theory is
premised solely on adverse events that occurred before
Defendant received FDA approval for Jardiance. Defendant
argues that any state law duty under the TPLA to provide a
different warning at the time of Jardiance's FDA approval
is preempted because, pursuant to federal regulations and
Supreme Court precedent, the FDA assessed the warning at the
time of approval, deemed Jardiance to be safe and effective
when accompanied by that warning, and required Jardiance to
be accompanied by the warning approved by the FDA at the
commencement of marketing Jardiance. Accordingly, Defendant
argues that both Plaintiff's strict liability and
negligence claims, predicated on a failure-to-warn theory,
are preempted by federal law. Defendant also argues that,
even if Plaintiff's failure-to-warn theory is not
preempted, she has not plausibly alleged how the Jardiance
label was defective or unreasonably dangerous or how the
alleged defect in the Jardiance label caused her injuries.
Court has previously noted,
[t]he TPLA governs products liability actions in Tennessee
and defines “product liability action[s]” as
“all actions brought for or on account of personal
injury, death or property damage caused by or resulting from
the manufacture, construction, design, formula, preparation,
assembly, testing, service, warning, instruction, marketing,
packing, or labeling of any product.” The TPLA also
encompasses several different theories of products liability:
“strict liability in tort; negligence; breach of
warranty, express or implied; breach of or failure to
discharge a duty to warn or instruct, whether negligent or
innocent; misrepresentation, concealment, or nondisclosure,
whether negligent or innocent; or under any other substantive
legal theory in tort or contract whatsoever.”
Strayhorn v. Wyeth Pharm., Inc., 887 F.Supp.2d 799,
813 (W.D. Tenn. 2012) (internal footnotes omitted). To
maintain a claim under the TPLA, regardless of the theory of
recovery, “the plaintiff must show that: (1) the
product was defective and/or unreasonably dangerous, (2) the
defect existed at the time the product left the
manufacturer's control, and (3) the plaintiff's
injury was proximately caused by the defective
product.” Sigler v. Am. Honda Motor Co., 532
F.3d 469, 483 (6th Cir. 2008). See also Tenn. Code
Ann. § 29-28-105(a) (providing that, under the TPLA, a
plaintiff may recover for injuries caused by a product that
was “in a defective condition or unreasonably dangerous
at the time [the product] left the control of the
manufacturer or seller”).
Tennessee law, “[m]anufacturers of prescription drugs .
. . have a duty to market and distribute their products in a
way that minimizes the risk or danger . . . [and] may
discharge their duty by distributing the drugs with proper
directions and adequate warnings;” adequate warnings
are defined as those that “contain a full and complete
disclosure of the potential adverse reactions to the
drug.” Pittman v. Upjohn Co., 890 S.W.2d 425,
428-29 (Tenn. 1994). “To plead a ‘failure to
warn' claim, Plaintiff must allege facts for the Court to
infer that the Device was ‘unreasonably dangerous'
within the meaning of T.C.A. § 29-28-102(8).”
Maness v. Boston Sci., 751 F.Supp.2d 962, 970 (E.D.
Tenn. 2010) (footnote omitted).
noted by Defendant, the FDA has the sole authority to approve
prescription drugs for sale in the United States, and the
Federal Food, Drug, and Cosmetic Act requires drug
manufacturers to gain FDA approval before marketing or
selling a new drug in interstate commerce. 21 U.S.C. §
355(a). To receive approval, the drug must “meet the
statutory standards for safety and effectiveness,
manufacturing and controls, and labeling, ” as
determined by the FDA. 21 C.F.R. § 314.105(c)
(“[The] FDA is required to exercise its scientific
judgment to determine the kind and quantity of data and
information an applicant is required to provide for a
particular drug to meet the statutory standards.”) The
NDA or sNDA must include “the labeling proposed
to be used” for the drug, 21 U.S.C. §
355(b)(1)(F), 21 C.F.R. § 314.50(c)(2)(i), and “a
discussion of why the [drug's] benefits exceed the risks
under the conditions stated in the labeling.” 21 C.F.R.
§ 314.50(d)(5)(viii). The NDA or sNDA must also include
“[t]he proposed text of the labeling . . . with
annotations to the information in the [application] that
support the inclusion of each statement . . . .”
Id. § 314.50(c)(2)(i). To approve an NDA or
sNDA, the FDA must determine, “based on a fair
evaluation of all material facts, ” that the proposed
label is not “false or misleading in any particular,
” 21 U.S.C. § 355(d)(7), or otherwise “does
not comply with the requirements for labels and
labeling.” 21 C.F.R. § 314.125(b)(6)-(8). Once the
FDA has approved an NDA or sNDA, the manufacturer must use
the FDA-approved label. 21 U.S.C. §§ 331(c),
333(a), 352(a), (c).
the FDA approves a drug, there are two ways a manufacturer
can change the drug's label. “First, the default
rule is that a manufacturer must secure FDA approval for a
proposed change prior to distributing the product with the
changed label.” In re Celexa & Lexapro Mktg.
& Sales Practices Litig., 779 F.3d 34, 37 (1st Cir.
2015) (citation omitted). Second, a drug manufacturer can,
without prior FDA approval, make certain types of changes to
the drug's label by sending a “supplement
submission” to the FDA pursuant to the CBE
process. 21 C.F.R. § 314.70(c)(6)(iii).
the CBE process, the drug manufacturer must satisfy two
requirements. First, the label change must reflect
“newly acquired information.” Id.
“Newly acquired information” is defined as
“data, analyses, or other information not previously
submitted to the Agency, which may include (but are not
limited to) data derived from new clinical studies, reports
of adverse events, or new analyses of previously submitted
data (e.g., meta-analyses) if the studies, events, or
analyses reveal risks of a different type or greater severity
or frequency than previously included in submissions to
FDA.” 21 C.F.R. § 314.3(b). Second, the label
change must be for the purpose of accomplishing at least one
of five objectives, including “[t]o add or strengthen a
contraindication, warning, precaution, or adverse reaction
for which the evidence of a causal association satisfies the
standard for inclusion in the labeling . . . .” 21
C.F.R. § 314.70(c)(6)(iii)(A).
present case, any claim that Plaintiff has made against
Defendant based on the alleged inadequacy of the initial FDA
approved label fails as a matter of law because Defendant was
required to use that label when it first marketed Jardiance
and could not have changed the label after FDA approval based
on alleged pre-launch data that was known to the FDA at the
time of the approval. See In re Celexa, 779 F.3d at
43 (affirming dismissal of complaint because defendants could
not have independently changed drug label at time of FDA
approval). See alsoUtts v. Bristol-Myers Squibb
Co., 26 F.Supp.3d 66 (S.D.N.Y. 2016) (holding that
failure-to-warn claims were preempted when claims were
premised on adequacy of the label as approved by FDA when
drug was first marketed and when plaintiffs did not plead
“newly acquired information” that would have
allowed the manufacturer to independently change drug label
to add or improve warnings pursuant to CBE process); In
re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices
& Prods. Liab. Litig., 185 F.Supp.3d 761, ...