United States District Court, W.D. Pennsylvania
WILLIAM L. BELL, JR, Plaintiff,
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG, BOEHRINGER INGELHEIM INTERNATIONAL GMBH, AND; AND ELI LILLY & COMPANY, Defendants.
Flowers Conti Chief United States District Judge
William L. Bell, Jr. ("Bell") alleges that he
developed an acute kidney injury as a direct result of taking
the prescription drug Jardiance. The court dismissed the
original complaint in its entirety based upon the lack of
actual facts pled about how each defendant acted negligently
or fraudulently in Jardiance's design or warnings or how
each defendant's alleged breaches of the standard of care
caused Bell's injuries. (February 15, 2018 Opinion, ECF
No. 20). The court gave Bell leave to file an amended
complaint, but cautioned him to plead how the design or
warnings were faulty and to assure that the complaint
contained sufficient factual allegations to render the claims
"plausible" against each defendant, because the
court was unlikely to permit further amendment. Id.
filed an amended complaint. (ECF No. 22). Defendants
Boehringer Ingelheim Pharmaceuticals, Inc.
("BrPI") and Eli Lilly & Company
("Lilly") renewed their motions to dismiss the
amended complaint in its entirety. (ECF Nos. 24, 26). Both
defendants contend that Bell again failed to plead sufficient
facts to support any cognizable claims. Lilly filed a
separate motion, arguing that because BIPI is the sole
applicant holder of the Jardiance New Drug Application
("NDA") filed with the Food and Drug Administration
("FDA") Lilly never had authority to change
Jardiance's labeling or design. The motions are fully
briefed and ripe for disposition.
may properly look at public records without converting a
motion to dismiss into one for summary judgment. Johnson
v. Talton, No. CV 17-01446, 2018 WL 1427086, at *1 (W.D.
Pa. Mar. 22, 2018) (citing Southern Cross Overseas
Agencies, Inc. v. Wah Kwong Shipping Group Ltd., 181
F.3d 410, 426 (3d Cir. 1999), and Pension Benefit Guar.
Corp. v. White Consol. Indus., 998 F.2d 1192, 1196 (3d
Cir. 1993)). A plaintiff with a legally deficient claim
cannot survive a motion to dismiss simply by failing to
attach a dispositive document on which he relied. Pension
Ben. Guar. Corp., 998 F.2d at 1196.
court will take judicial notice of the FDA publication
Approved Drug Products with Therapeutic Equivalence
Evaluations (the "Orange Book"). The Orange
Book is a "publically available list of drugs which have
been approved [by the FDA] for safety and
effectiveness." Warren v. Boehringer Ingleheim
Pharm. Inc., No. 116CV01326SEBDML, 2017 WL 3970666, at
*16 (S.D. Ind. Sept. 8, 2017) (citing Abbott Labs. v.
Zenith Labs., Inc., 934 F.Supp. 925, 927 (N.D. 111.
1995), and Morris v. Wyeth, Inc., No. 9-854, 2012 WL
601455 (W.D. La. Feb. 23, 2012)). The Orange Book lists BIPI
as the sole "applicant holder" for Jardiance.
Id.; avail, at
product.cfm?Appl Type=N&Appl No=204629, last
visited on May 22, 2018.
courts have concluded that FDA warning letters are publicly
available evidence of agency actions, of which the court may
take judicial notice. Bowling v. Johnson &
Johnson, No. 17-CV-3982, 2018 WL 1587598, at *4
(S.D.N.Y. Mar. 28, 2018) (collecting decisions); accord
Alfred v. Frito-LayN. Am., Inc., No. 17-CV-1345, 2018 WL
1185227, at *2 (S.D. Cal. Mar. 7, 2018) ("FDA warning
letters available on the FDA's website are also
appropriate subjects of judicial notice") (citation
omitted); Fed.R.Evid. 201. In Salvio v. Amgen, Inc.,
810 F.Supp.2d 745, 750-51 (W.D. Pa. 2011), the court took
judicial notice of the medication's package warning label
in granting a motion to dismiss design and failure to warn
claims. The court will consider FDA warning letters and label
changes regarding SGLT2 inhibitors such as Jardiance.
See, e.g., Bowling, 2018 WL 1587598, at *4 (and
decisions cited therein).
court will consider the FDA's NDA Approval letter (ECF
No. 25-1), which is referenced in the amended complaint (ECF
No. 22 ¶¶ 21-22) and integrally related to the
claims in this case. The court will consider the information
available at the FDA website,
www.accessdata.fda.gov, last visited on May 22,
2018, to which both parties have cited. (ECF No. 22 n. 3, 4;
ECF No. 25 at 8 n.4). These documents will be considered for
their existence, but not for the truth of the facts recited
therein. Southern Cross Overseas Agencies, 181 F.3d
the court's conclusion in the February 15, 2018
memorandum opinion that the allegations in Bell's
original complaint were conclusory and substantially
identical to those held to be insufficient in several other
cases, the amended complaint makes only a few factual
revisions. (Compare ECF Nos. 1, 22). The court will
incorporate its recitation of the factual background in the
February 15, 2018 memorandum opinion and set forth the
additional facts to be considered from the amended complaint
and documents from the FDA website.
As set forth in the complaint, in July 2014, defendants
submitted an NDA to the FDA for Jardiance. Complaint ¶
20 (ECF No. 1). In August 2014, the FDA approved Jardiance
for the treatment of Type II diabetes. Id. ¶
21. Jardiance is the tradename for the drug empagliflozin,
which is a member of the gliflozin class of sodium-glucose
cotransporter 2 ("SGLT2") inhibitors. Id.
¶ 22. SGLT2 inhibitors are designed to inhibit renal
glucose reabsorption with the goal of lowering blood glucose.
Id. ¶24. Excess glucose is not metabolized.
Instead, it is excreted through the kidneys. Id.
¶ 24. Jardiance is indicated for only improved glycemic
control in type 2 adult diabetics, but defendants market it
for off label purposes, including weight loss, reduced blood
pressure and improved glycemic control in type 1 diabetes.
Id. ¶ 25. Since the release of Jardiance, the
FDA has received a significant number of reports of diabetic
ketoacidosis. Id. ¶ 26. Bell alleges that
defendants knew about the significant risk of diabetic
ketoacidosis but did not adequately warn consumers or the
medical community about the severity of such risks.
Id. ¶ 30.
On June 13, 2015, Bell began taking Jardiance per his
doctor's instructions, primarily to treat diabetes.
Id. ¶ 32. Bell relied on defendants' claims
that Jardiance was safe and effective for the treatment of
diabetes. Id. ¶ 35. On August 31, 2015, Bell
suffered acute renal failure. Id. ¶ 37.
15, 2018 memorandum opinion, ECF No. 20).
response to the court's comment that Bell did not plead
the roles of each defendant, he now pleads that BIPI and
Lilly agreed to jointly develop and commercialize diabetes
compounds and "worked in conjunction to research,
develop, test and market Jardiance." (ECF No. 22 ¶
19). In response to the court's comment that Bell failed
to identify alternative, safer designs, he now pleads that
other products were available, including metformin,
Diabinese, Amaryl and Glucotrol. (ECF No. 22 ¶ 41). The
amended complaint does not contain any facts about why these
products are safer or why the design of Jardiance was
added some details about his own condition. He developed
type-2 diabetes in 2005. (ECF No. 22 ¶ 34). He began
taking 25 milligrams of Jardiance daily on June 13, 2015, as
prescribed by his physicians at Joslin Diabetes Center. (ECF
No. 22 ¶ 34). At the time he was prescribed Jardiance,
he had normal kidney function. (ECF No. 22 ¶ 34). He
suffered an acute kidney injury on August 31, 2015. (ECF No.
22 ¶ 38). Bell avers that despite ...