United States District Court, E.D. Kentucky, Northern Division
MEMORANDUM OPINION AND ORDER
R. WILHOLT JR., UNITED STATES DISTRICT JUDGE
matter is before the Defendants' Motions to Dismiss
[Docket Nos. 20 and 21]. The motions have been fully briefed
by the parties [Docket Nos. 20-1, 28, 29, 30 and 31], For the
reasons stated herein, the Court finds that dismissal would
not be appropriate at this time.
case arises out of Plaintiff Bonnie Darbro's alleged
development of diabetic ketoacidosis ("DKA")
shortly after she began taking Jardiance. Boehringer
Ingelheim Pharmaceuticals, Inc. (" BIPI") holds the
New Drug Application ("NDA") for Jardiance, and
BIPI and Eli Lilly and Company ("Lilly") co-market
and distribute the product.
their Complaint, Plaintiffs state that Plaintiff Bonnie
Darbro was prescribed Jardiance to treat her diabetes by her
physician [Complaint, Docket No. 1, % 32]. Jardiance
(empagliflozin) was approved by the FDA in August
2014 as a safe and effective for the treatment of Type 2
diabetes. Id. ¶ 21. Plaintiffs allege that Ms.
Darbro began treatment with Jardiance "in or about
October 14, 2014, primarily to treat diabetes."
Id. ¶ 32. Approximately 10 days after beginning
treatment with Jardiance, Plaintiffs allege that Ms. Darbro
developed and was diagnosed with DKA "resulting in
admission to the intensive care unit." Id.
¶ 37. In addition to developing DKA, Plaintiffs allege
that Ms. Darbro experienced "severe and permanent
physical and emotional injuries ... pain and suffering,
emotional distress, loss of enjoyment of life, and economic
loss, including significant expenses for medical care and
treatment which will continue in the future" and
"other related health complications." Id.
¶¶ 45, 66.
on these allegations, Plaintiffs filed this civil action,
seeking "actual compensatory, and punitive damages from
Defendants and asserting thirteen causes of action: (Count I)
Products Liability - Design Defect (Strict Liability); (Count
II) Products Liability -Failure to Warn (Strict Liability);
(Count m) Willful and Wanton Conduct or Gross Negligence;
(Count IV) Negligence; (Count V) Breach of Express Warranty;
(Count VI) Breach of Implied Warranty; (Count VII) Fraudulent
Misrepresentation; (Count VIII) Negligent Misrepresentation;
(Count IX) Negligent Design; (Count X) Fraudulent
Concealment; (Count XI) Fraud; (Count XT!) Violation of the
Kentucky Consumer Protection Act ("KCPA"); and
(Count XIII) Loss of Consortium on behalf of Plaintiff Jerry
Gibson. Plaintiffs assert each of these thirteen claims
against all named Defendants based on their alleged role in
the design, manufacture, marketing, advertisement, licensing,
distribution, and sale of Jardiance. Id.
¶¶ 1, 5.
seek dismissal of all claims asserted herein, arguing that
the Complaint pleads insufficient facts and recites
conclusory allegations, thereby failing to meet threshold
federal pleadings requirements, and it asserts several claims
not recognized under Kentucky law.
Lilly also argues that all claims asserted against are
preempted and, as such, fails to state a claim upon which
relief can be granted.
purpose of a motion to dismiss is to allow a defendant to
test whether, as a matter of law, the plaintiff is entitled
to legal relief. See, Mayer v. Mylod, 988 F.2d 635,
638 (6, h Cir. 1993). In scrutinizing a complaint
under Rule 12(b)(6), the Court is required to "accept
all well-pleaded factual allegations of the complaint as true
and construe the complaint in the light most favorable to the
plaintiff." Dubay v. Wells, 506 F.3d 422, 426
(6th Cir.2007). A complaint need not contain "detailed
factual allegations". However, it must allege more than
"a formulaic recitation of the elements of a cause of
action." Bell Atl. Corp. v. Twombly, 550 U.S.
544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). A complaint
will withstand a motion to dismiss if it "contain[s]
sufficient factual matter, accepted as true, to state a claim
to relief that is plausible on its face." Ashcroft
v. Iqbal t 556 U.S. 662, 129 S.Ct. 1937,
1949, 173 L.Ed.2d 868 (2009). A complaint has "facial
plausibility" if the plaintiff pleads factual content
that allows the court to draw the reasonable inference that
the defendant is liable for the misconduct alleged."
Hensley Mfg. v. ProPride, Inc., 579 F.3d 603, 609
(6th Cir.2009) (quoting Iqbal, 129 S.Ct. at 1949).
arguments urging dismissal elevate form over substance.
Defendants implore this Court to engage in a word by word
dissection of the Complaint, suggesting, in effect, that the
trees should obscure the forest. The Court disagrees. At the
very least, the sequence of events alleged by Plaintiffs,
to-wit, that Ms. Darbro was prescribed a medication designed
and distributed by the Defendants and a mere 10 days after
after she began taking the drug, she developed a serious
illness, requiring hospitalization, present a plausible
scenario of negligence and perhaps other wrongdoing. Without
the benefit of discovery, indeed the first interrogatoiy has
yet to be served, the first deposition yet to be noticed,
there is not much more to discern. Such is the point of
discoveiy, is it not? Defendants' argument that
Plaintiffs' case is lost is woefully premature.
Court finds that Plaintiffs have plead sufficient facts upon
which one could draw a reasonable inference that the
Defendants are liable for the misconduct alleged, thereby
passing Jqbal muster.
not to say that Plaintiffs will ultimately prevail. However,
if Plaintiffs' claims are to fail before a trial, they
will fail upon summary ...