Doe v. AstraZeneca Pharmaceuticals LP et al
Filing
20
ORDER & REASONS: ORDERED that AstraZeneca's Motion to Dismiss and Amend Case Caption (Rec. Doc. 15) is GRANTED. FURTHER ORDERED that Plaintiff's claims are DISMISSED WITHOUT PREJUDICE. Plaintiff shall file an amended complaint within tw enty-one (21) days, lest Plaintiff's claims be dismissed with prejudice. FURTHER ORDERED that the caption of this case be amended to reflect Plaintiff's true identity. FURTHER ORDERED that Plaintiff's Motion for Oral Argument (Rec. Doc. 18) is DENIED. Signed by Judge Carl Barbier on 8/5/15. (sek)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
JANE DOE
CIVIL ACTION
VERSUS
NO: 15-438
ASTRAZENECA PHARMECEUTICALS,
SECTION: J(2)
LP, ET AL
ORDER AND REASONS
Before the Court is a Motion to Dismiss and Amend Case
Caption
(Rec.
Doc.
15)
filed
by
Defendant,
AstraZeneca
Pharmaceuticals, LP (“AstraZeneca”), and an Opposition thereto
(Rec. Doc. 17) by Plaintiff, Jane Doe (“Plaintiff”). Plaintiff
has
requested
that
the
Court
conduct
Oral
Argument
on
the
instant motion. (Rec. Doc. 18). Having considered the motion,
the parties’ submissions, the record, and the applicable law,
the
Court
finds,
for
the
reasons
expressed
below,
that
the
motion should be GRANTED.
PROCEDURAL AND FACTUAL BACKGROUND
In her complaint, Plaintiff, who has requested that her
identity remain anonymous, alleges that she sustained adverse
effects from her use of Seroquel and/or Seroquel XR, and their
generics,
Quetiapine
and
Quetiapine
1
Fumarate,
respectively.
AstraZeneca is the manufacturer of Seroquel and Seroquel XR,
whereas Quetiapine and Quetiapine Fumarate are manufactured by
Defendants
Lupin
Pharmaceuticals,
Inc.
(“Lupin”)
and
Teva
Pharmaceuticals, Inc. (“Teva”). Seroquel, Seroquel XR, and their
generics are approved by the U.S. Food and Drug Administration
(“FDA”)
for
treatment
of
schizophrenia
and
bipolar
disorder.
(Rec. Doc. 1, p. 4). Plaintiff alleges that she was prescribed
Seroquel, Seroquel XR, Quetiapine, and Quetiapine Fumarate “for
sleep.” (Rec. Doc. 1, p. 4). Plaintiff further alleges that as a
result of taking these prescription medications she sustained a
litany of injuries including, “weight gain, inability to lose
weight,
medical
suffering,
severe
complications,
abdominal
physical
pain,
damages,
pain
gastrointestinal
and
problems,
hyperlipidia, mental anguish, [and] emotional distress,” as well
as a number of more personal injuries which Plaintiff preferred
to describe in a document filed under seal. (Rec. Doc. 1, p. 8;
Rec. Doc. 4). In her complaint, Plaintiff alleges that Seroquel,
Seroquel
XR,
and
their
generics
are
“unreasonably
dangerous”
both because AstraZeneca failed to provide an adequate warning
regarding
the
drugs’
adverse
effects
to
Plaintiff
or
her
physician, and because the medications fail to conform to the
express
warranty
that
they
are
“safe,
effective
product[s].”
(Rec. Doc. 1, pp. 11, 15). Upon Plaintiff’s motion, on June 10,
2
2015, this Court dismissed Plaintiff’s claims against Lupin and
Teva, leaving AstraZeneca as the sole defendant in this matter.
AstraZeneca has filed the instant motion seeking dismissal
of
all
Plaintiff’s
claims
pursuant
to
Federal
Rule
of
Civil
Procedure 12(b)(6), and also requesting that the Court amend the
case caption of this matter to disclose Plaintiff’s identity
pursuant to Federal Rule of Civil Procedure 10(a).
PARTIES’ ARGUMENTS
AstraZeneca
first
argues
that
all
claims
asserted
by
Plaintiff in her complaint which fall outside the scope of the
Louisiana Products Liability Act (“LPLA”) must be dismissed, as
the LPLA provides the exclusive remedy for liability against a
manufacturer
for
damage
caused
by
its
products.
AstraZeneca
further asserts that even those claims which the Court deems to
fall within the scope of the LPLA should be dismissed because
Plaintiff has failed to allege sufficient facts to state a claim
under any of the four theories of liability enumerated by the
LPLA. AstraZeneca also requests that the Court amend the caption
of the case to reflect Plaintiff’s true identity, because the
present
circumstances
do
not
require
that
Plaintiff
litigate
anonymously.
In response, Plaintiff maintains that her complaint asserts
plausible
LPLA
claims
under
theories
3
of
failure
to
provide
adequate
warnings
and
failure
to
comply
with
an
express
warranty. Moreover, in her Opposition, Plaintiff requests leave
to
amend
support
her
a
complaint
claim
construction
that
or
to
include
Seroquel
composition
is
and/or
additional
information
to
dangerous
in
unreasonably
in
design,
and
to
remove
extra allegations pertaining to Defendants Teva and Lupin, who
have been dismissed from this matter. Plaintiff also maintains
that her complaint contains no claims beyond the scope of the
LPLA.
Finally,
Plaintiff
requests
that
the
case
caption
be
maintained to prevent disclosure of her true identity, because
this
lawsuit
would
reveal
private
information
regarding
her
medical condition.
LEGAL STANDARD
Under the Federal Rules of Civil Procedure, a complaint
must contain “a short and plain statement of the claim showing
that
the
pleader
is
entitled
to
relief.”
Fed.
R.
Civ.
P.
8(a)(2). The complaint must “give the defendant fair notice of
what the claim is and the grounds upon which it rests.” Dura
Pharm.,
Inc.
v.
Broudo,
544
U.S.
336,
346
(2005).
The
allegations “must be simple, concise, and direct.” Fed. R. Civ.
P. 8(d)(1).
“Under
Rule
12(b)(6),
a
claim
may
be
dismissed
when
a
plaintiff fails to allege any set of facts in support of his
4
claim which would entitle him to relief.” Taylor v. Books A
Million,
Inc.,
296
F.3d
376,
378
(5th
Cir.
2002)
(citing
McConathy v. Dr. Pepper/Seven Up Corp., 131 F.3d 558, 561 (5th
Cir. 1998)). To survive a Rule 12(b)(6) motion to dismiss, the
plaintiff must plead enough facts to “state a claim to relief
that is plausible on its face.” Ashcroft v. Iqbal, 556 U.S. 662,
678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544,
547 (2007)). A claim is facially plausible when the plaintiff
pleads
facts
inference
that
that
the
allow
the
court
defendant
is
to
“draw
the
reasonable
for
the
misconduct
liable
alleged.” Id. A court must accept all well-pleaded facts as true
and
must
draw
all
reasonable
inferences
in
favor
of
the
plaintiff. Lormand v. U.S. Unwired, Inc., 565 F.3d 228, 232-33
(5th Cir. 2009); Baker v. Putnal, 75 F.3d 190, 196 (5th Cir.
1996). The court is not, however, bound to accept as true legal
conclusions couched as factual allegations. Iqbal, 556 U.S.at
678.
DISCUSSION
A. Non-LPLA Claims
The LPLA “establishes
the exclusive theories
of
liability
for manufacturers for damage caused by their products,” and “a
claimant may not recover from a manufacturer for damage caused
by a product on the basis of any theory of liability that is not
5
set
forth
(2014).
pleading
in
[the LPLA].”
AstraZeneca
which
La.
contends
claims
are
Rev.
that
being
Stat.
“it
is
asserted
Ann.
§
unclear
under
the
9:2800.52
from
the
LPLA
or
otherwise,” and submits that all non-LPLA claims asserted by
Plaintiff must be dismissed pursuant to Rule 12(b)(6). (Rec.
Doc. 15-1, p. 4). In response, Plaintiff maintains that “there
are
no
non-Louisiana
Products
Liability
Act
claims
in
this
case.” (Rec. Doc. 17, p. 10).
The Court agrees with AstraZeneca that it is difficult to
determine from Plaintiff’s complaint and Opposition the exact
type and number of claims she is attempting to assert against
AstraZeneca and whether these fall within or outside the scope
of the LPLA. Therefore, to the extent that Plaintiff’s complaint
contains non-LPLA claims, these are preempted by the LPLA. See
Davis v. Teva Pharm. USA, Inc., No. 13-6365, 2014 WL 4450423, at
*4 (E.D. La. Sept. 10, 2014) (citing Stahl v. Novartis Pharms.
Corp., 283 F.3d 254, 261 (5th Cir. 2002)).
B. LPLA Claims
AstraZeneca next asserts that Plaintiff has failed to state
a plausible claim under any of the four theories of liability
provided for by the LPLA. AstraZeneca specifically contends that
Plaintiff’s
complaint
contains
only
“irrelevant
factual
assertions and legal conclusions,” and is devoid of sufficient
6
relevant factual allegations to state a plausible claim. (Rec.
Doc. 15-1, p. 2). In response, Plaintiff argues that she has set
forth a sufficient factual basis to support her claims under the
LPLA,
and
that
AstraZeneca
is
the
additional
information
factual
which
is
information
to
be
sought
by
appropriately
disclosed through the discovery process. (Rec. Doc. 17, p. 3).
Plaintiff maintains that her complaint asserts plausible claims
under
the
LPLA
for
the
unreasonable
danger
of
Seroquel
and
Seroquel XR under theories of failure to provide an adequate
warning and failure to conform to an express warranty. (Rec.
Doc. 17, p. 3). Moreover, Plaintiff requests the Court’s leave
to amend her complaint to assert additional claims under the
LPLA for unreasonable danger in construction or composition and
design, based on information which has come to light since the
filing of her original complaint. (Rec. Doc. 17, p. 7).
In order to prevail on a claim brought pursuant to the
LPLA, a plaintiff must establish the following elements: (1)
that the defendant is a manufacturer of the product; (2) that a
characteristic of the product was the proximate cause of the
claimant’s damage; (3) that the characteristic made the product
“unreasonably
dangerous”;
and
(4)
that
the
claimant’s
damage
arose from a reasonably anticipated use of the product. La. Rev.
Stat. Ann. § 9:2800.54(A) (2014). The LPLA defines a product as
7
“unreasonably
dangerous”
if
it
meets
at
least
one
of
the
following criteria:
(1)
(2)
(3)
The product is unreasonably dangerous in construction
or composition
The product is unreasonably dangerous in design
The product is unreasonably dangerous because an
adequate warning about the product has not been
provided
The product is unreasonably dangerous because it does
not conform to an express warranty made by the
manufacturer of the product.
(4)
La. Rev. Stat. Ann. § 9:2800.54(B); see also Stahl, 283 F.3d at
261; Jefferson v. Lead Indus. Ass’n, Inc., 930 F.Supp. 241, 245
(E.D. La. 1996 (Vance, J.).
In
her
complaint,
Plaintiff
asserts
that
Seroquel
and
Seroquel XR were unreasonably dangerous as defined by the LPLA
because they lacked adequate warnings and because they failed to
conform to an express warranty provided by AstraZeneca. Despite
labeling
these
Plaintiff
has
claims
under
claims
failed
either
as
to
such,
allege
of
AstraZeneca
sufficient
these
asserts
facts
theories
of
to
that
support
liability.
Specifically, AstraZeneca notes that Plaintiff’s complaint lacks
information
regarding
the
dates
on
which
Plaintiff
was
prescribed the drugs, the duration and number of times Plaintiff
took the drugs, and the dates on which she began experiencing
adverse symptoms. (Rec. Doc. 15-1, p. 2). In response, Plaintiff
maintains that these facts were unnecessary to state a plausible
8
claim.
Despite
not
providing
any
additional
facts
in
her
Opposition, Plaintiff does provide the Court with nearly four
unnecessary pages of direct citations of various provisions of
the LPLA.
In order to maintain a failure-to-warn claim, “a plaintiff
must
demonstrate
that
that
may
damage
cause
reasonable
care
characteristic
to
and
the
product
and
the
provide
its
possessed
manufacturer
an
danger
a
adequate
to
users
characteristic
failed
warning
and
to
of
handlers
use
such
of
the
product.” Stahl, 283 F.3d at 261 (citing La. Rev. Stat. Ann. §
9:2800.57(A)
(2014)).
unnecessarily
repetitive
AstraZeneca
Plaintiff
extent
of
However,
failed
or
the
to
Plaintiff’s
legally
provide
Plaintiff’s
adverse
despite
the
conclusive
adequate
physician
effects
complaint
of
lengthiness
assertions
warnings
regarding
Seroquel
of
contains
the
and
Plaintiff’s
to
that
either
nature
and
Seroquel
XR.
allegations,
nowhere in her complaint does she make mention of any specific
adverse effect of which AstraZeneca failed to warn, or assert a
proper warning which she contends would have been appropriate.
Due to the vagueness of Plaintiff’s complaint, an issue remains
regarding
whether
warnings
regarding
AstraZeneca
specific
failed
adverse
to
provide
effects
of
the
adequate
drugs.
Plaintiff must amend her complaint to specifically allege the
9
reasons why the warnings provided by AstraZeneca regarding the
adverse effects of Seroquel and Seroquel XR were inadequate.
In order to maintain a claim for failure to conform to an
express
warranty
under
the
LPLA,
a
plaintiff
must
establish
that: “(1) the manufacturer made an express warranty regarding
the product, (2) the plaintiff was induced to use the product
because of that warranty, (3) the product failed to conform to
that
express
proximately
warranty,
caused
and
because
(4)
the
the
plaintiff’s
express
warranty
damage
was
was
untrue.”
Caboni v. Gen. Motors Corp., 278 F.3d 448, 452 (5th Cir. 2002)
(citing
La.
complaint,
Rev.
Stat.
Plaintiff
Ann.
§
9:2800.58
repeatedly
asserts
(2014)).
that
In
her
AstraZeneca
“expressly warranted in its materials presented to the FDA, its
website
and
promotional,
upon
and
information
and
informational
belief[,]
materials
that
safe, effective product.” (Rec. Doc. 1, p. 15).
to
reference
specific
promises
or
its
marketing,
Seroquel
is
a
Plaintiff fails
representations
made
by
AstraZeneca or to explain how the drugs prescribed to her failed
to conform to these representations. In order to proceed with
this litigation, Plaintiff must amend her complaint to include
sufficient factual allegations to support her claim for failure
to conform with an express warranty.
10
In her Opposition, Plaintiff also requests leave to amend
her
complaint
to
include
additional
LPLA
clams
premised
on
Seroquel and Seroquel XR’s unreasonable danger in construction
or composition and design. (Rec. Doc. 17, p. 10). Federal Rule
of Civil Procedure 15(a) provides that leave should be granted
to amend pleadings “when justice so requires.” Fed. R. Civ. P.
15(a). A decision to permit a party to amend pleadings lies
within the sound discretion of the trial court. Tyson v. Tanner,
No.
08-4445,
2010
WL
4808504,
at
*1
(citing
Addington
v.
Farmer’s Elevator Mut. Ins. Co., 650 F.2d 663, 666 (5th Cir.
1981)).
Plaintiff
complaint,
she
asserts
has
that
become
since
aware
of
the
filing
additional
of
her
testimony
regarding the nature and adverse effects of Seroquel, on which
she could base claims for unreasonably dangerous construction
and design. (Rec. Doc. 7-8). The Court finds that leave to amend
the complaint on this basis is appropriate. The Court, however,
cautions counsel for Plaintiff that it will not suffice to file
an
amended
complaint
in
which
she
alleges
purely
legal
conclusions without any factual basis.
C. Amendment of the Case Caption
Finally, AstraZeneca requests that the Court amend the case
caption
to
specifically
reveal
Plaintiff’s
asserts
that
true
Plaintiff
11
has
identity.
no
right
AstraZeneca
to
proceed
anonymously,
as
she
will
suffer
no
injury
other
than
mere
embarrassment as a result of the disclosure of her real name.
Plaintiff maintains that she should be permitted to litigate
anonymously, because “even one sentence, revealing [her] name
and stating that she has taken Seroquel will reveal that she has
a mental condition diagnosis [sic] and she should be afforded
privacy and protection.” (Rec. Doc. 17, p. 10).
Federal Rule of Civil Procedure 10(a) requires that the
title of a complaint disclose the names of all parties involved.
Fed.
R.
Civ.
P.
10(a).
This
rule
is
not
without
exception,
however, and in limited circumstances, a party may be permitted
to
proceed
anonymously
due
to
interests
of
privacy.
Doe
v.
Griffon Mgmt., LLC, No. 14-2626, 2014 WL 7040390, at *1 (E.D.
La. Dec. 11, 2014) (Africk, J.). Although the Fifth Circuit has
refused
to
adopt
a
“hard
whether
a
party
should
and
be
fast”
formula
permitted
to
for
determining
litigate
under
a
pseudonym, it has recognized that such a determination “requires
a
balancing
party’s
of
privacy
considerations
against
the
calling
customary
for
and
maintenance
of
a
constitutionally-
embedded presumption of openness in judicial proceedings.” Doe
v. Stegall, 653 F.2d 180, 186 (5th Cir. 1981). “Examples of
areas
where
involving
courts
abortion,
have
birth
allowed
pseudonyms
control,
12
include
transsexuality,
cases
mental
illness,
welfare
rights
of
illegitimate
children,
AIDS,
and
homosexuality.” Griffon Mgmt., 2014 WL 7040390, at *2 (citing
Doe v. Megless, 654 F.3d 404, 408 (3d Cir. 2011)).
Plaintiff has failed to show that the present circumstances
rise to those examples discussed in Doe v. Griffon Management.
Plaintiff maintains that requiring her to litigate under her
true identity would reveal that she suffers from mental illness.
However, nowhere in her pleadings has Plaintiff ever asserted
that she is afflicted with a mental condition. Instead, in her
Complaint,
she
states
that
she
was
prescribed
Seroquel
and
Seroquel XR “for sleep.” (Rec. Doc. 1, p. 4). Because Plaintiff
has
failed
warrant
show
anonymity,
interests
practice
to
at
of
stake
that
the
do
of
Court
the
circumstances
concludes
that
not
disclosure.”
outweigh
See
the
Stegall,
her
the
“almost
653
F.2d
complaint
privacy
universal
at
186.
Therefore, the caption of this case will be amended to reflect
Plaintiff’s true identity.
CONCLUSION
Accordingly,
IT IS HEREBY ORDERED that AstraZeneca’s Motion to Dismiss
and Amend Case Caption (Rec. Doc. 15) is GRANTED.
IT IS FURTHER ORDERED that Plaintiff’s claims are DISMISSED
WITHOUT
PREJUDICE.
Plaintiff
shall
13
file
an
amended
complaint
within
twenty-one
(21)
days,
lest
Plaintiff’s
claims
be
dismissed with prejudice.
IT IS FURTHER ORDERED that the caption of this case be
amended to reflect Plaintiff’s true identity.
IT
IS
FURTHER
ORDERED
that
Plaintiff’s
Motion
for
Oral
Argument (Rec. Doc. 18) is DENIED.
New Orleans, Louisiana this 5th day of August, 2015.
________________________________
CARL J. BARBIER
UNITED STATES DISTRICT JUDGE
14
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