Doe v. AstraZeneca Pharmaceuticals LP et al

Filing 39

ORDER & REASONS: ORDERED that AstraZeneca's Motion to Dismiss (Rec. Doc. 23) is GRANTED. AstraZeneca's Motion for Leave to File Reply (Rec. Doc. 38) is DENIED as moot. IT IS FURTHER ORDERED that Plaintiff's claims, with the exception of her Failure to Warn claim, are DISMISSED WITH PREJUDICE. Plaintiff's request for leave to amend her complaint is DENIED. IT IS FURTHER ORDERED that oral argument on this matter, set for October 7, 2015, at 9:30 a.m., is CANCELED. Signed by Judge Carl Barbier on 10/6/15. (sek)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA

HARLA ROBERTSON

CIVIL ACTION

VERSUS

NO: 15-438

ASTRAZENECA PHARMECEUTICALS,
LP, ET AL.

SECTION: J(2)

ORDER AND REASONS
Before the Court is a Motion to Dismiss in Part (Rec. Doc.
23)

filed

by

Defendant,

AstraZeneca

Pharmaceuticals,

LP

(“AstraZeneca”), and an Opposition thereto (Rec. Doc. 37) by
Plaintiff,

Harla

Robertson

(“Plaintiff”).

Plaintiff

also

requested oral argument on this matter. (Rec. Doc. 34.) Having
considered the motions, the parties’ submissions, the record,
and

the

applicable

law,

the

Court

finds,

for

the

reasons

expressed below, that AstraZeneca’s motion should be GRANTED.
PROCEDURAL HISTORY AND BACKGROUND FACTS
Plaintiff
Defendant
inadequate

Harla

AstraZeneca
warning

Robertson
in

and

originally

February

breach

of

2015,

filed

suit

asserting

express

warranty

against

claims

for

under

the

Louisiana Products Liability Act (“LPLA”). (Rec. Doc. 1.) The
original complaint contained “unnecessarily repetitive legally
1

conclusive assertions.” (Rec. Doc. 20, at 9.) AstraZeneca filed
a Motion to Dismiss for Failure to State a Claim, which this
Court granted. (See Rec. Doc. 15; Rec. Doc. 20.) However, this
Court allowed Plaintiff leave to amend her complaint, cautioning
that it would dismiss her claim with prejudice if she continued
to assert “purely legal conclusions without any factual basis.”
(Rec. Doc. 20, at 11, 14.)
In
sustained
Seroquel
Fumarate,
Seroquel

her

amended

adverse
XR,

and

complaint,

effects
their

respectively.
and

Fumarate

are

(“Lupin”)

and

Seroquel

from

her

generics,
AstraZeneca

XR,

whereas

manufactured
Teva

Plaintiff

by

use

of

Quetiapine
is

the

Quetiapine

Lupin

Pharmaceuticals,

alleges

that

Seroquel
and

and/or

Quetiapine

manufacturer
and

(“Teva”). 1

of

Quetiapine

Pharmaceuticals,

Inc.

she

Inc.

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. 21, at 6-7.)
Plaintiff

alleges

that

she

was

prescribed

Seroquel,

Seroquel XR, Quetiapine, and Quetiapine Fumarate to treat her
1

Upon Plaintiff’s motion, on June 10, 2015, this Court dismissed

Plaintiff’s claims against Lupin and Teva, leaving AstraZeneca
as the sole defendant in this matter.
2

bipolar disorder and difficulty sleeping. (Rec. Doc. 21, at 3.)
Plaintiff

further

prescription

alleges

including,

medications
“weight

complications,

that
she

gain,

physical

as

a

result

sustained

inability
damages,

a

to

pain

of

taking

litany

lose
and

of

weight,
suffering,

these

injuries
medical
severe

abdominal pain, gastrointestinal problems, hyperlipidia, chronic
inflammation

of

the

increased

panic

increased

gall

bladder,

attacks,

increased

crying

spells,

suicidal

[thoughts]

due

chronic

abdominal

emotional

distress,

gall

to

[and]

bladder

anxiety,

depression,

[thoughts],
pain,

aggravation

mental
of

removal,

suicidal
anguish,

pre-existing

conditions.” (Rec. Doc. 21, at 16-17.)
Plaintiff

claims

that

AstraZeneca

is

liable

as

a

manufacturer under the LPLA. She alleges that Seroquel, Seroquel
XR, and their generics are “unreasonably dangerous” (1) because
AstraZeneca failed to provide an adequate warning regarding the
drugs’

adverse

effects

to

Plaintiff

or

her

physician,

(2)

because the medications fail to conform to the express warranty
that

they

are

“safe,

effective

product[s],”

(3)

because

the

drugs are defective in design, and (4) because the drugs are
defective in construction or composition. (Rec. Doc. 21, at 18,
19, 22, 25.)
3

On

September

8,

AstraZeneca

filed

the

instant

motion

seeking dismissal of three of Plaintiff’s claims pursuant to
Federal Rule of Civil Procedure 12(b)(6). Plaintiff filed an
opposition

to

the

motion

on

October

1.

AstraZeneca

filed

a

Motion for Leave to File Reply (Rec. Doc. 38) on October 5.
PARTIES’ ARGUMENTS
In

its

Motion

to

Dismiss,

AstraZeneca

argues

that

Plaintiff’s amended complaint still does not pass muster under
Rule 12(b)(6). Specifically, it argues that Plaintiff failed to
state a claim that Seroquel, Seroquel XR, and their generics are
unreasonably dangerous (1) in construction or composition, (2)
in

design,

or

(3)

because

AstraZeneca

breached

an

express

warranty. Plaintiff’s claims, it asserts, are nothing more than
“unsupported legal conclusions and jumbled, irrelevant factual
allegations.”

(Rec.

Doc.

23.)

For

those

reasons,

AstraZeneca

asks this Court to dismiss the three claims listed above. It
does not challenge the sufficiency of Plaintiff’s allegations
that

the

drugs

were

unreasonably

dangerous

because

of

AstraZeneca’s failure to warn of the drugs’ adverse effects.
In

her

opposition,

Plaintiff

argues

that

the

amended

complaint states a claim that survives a Rule 12(b)(6) motion to
dismiss. Generally, Plaintiff opposes AstraZeneca’s “demands for
4

more

facts,”

which

she

contends

are

not

appropriate

at

this

stage of the proceedings. (Rec. Doc. 37, at 4.) In addition,
Plaintiff

claims

she

lists

the

patent

number

for

Seroquel,

Seroquel XR, and their generics in her complaint, as well as
some technical patent data. Id. at 2. According to Plaintiff,
this allegation is sufficient to state a claim for unreasonably
dangerous construction or composition and design. Id. In further
support of her argument, Plaintiff quotes extensively from the
LPLA,

claiming

that

her

amended

complaint

complies

with

the

requirements of the Act. Id. at 7-13.
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
claim which would entitle him to relief.” Taylor v. Books A
5

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
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
set forth in [the LPLA].” LA. REV. STAT. § 9:2800.52 (2014).
6

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.

§

9:2800.54(A)

(2014).

A

product

is

“unreasonably

dangerous” if it meets at least one of the following criteria:
(1) The
product
is
unreasonably
dangerous
in
construction or composition;
(2) The product is unreasonably dangerous in design;
(3) The product is unreasonably dangerous because an
adequate warning about the product has not been
provided; or
(4) The product is unreasonably dangerous because it
does not conform to an express warranty made by the
manufacturer of the product.
LA. REV. STAT. § 9:2800.54(B); see also Stahl v. Novartis Pharm.
Corp., 283 F.3d 254, 261 (5th Cir. 2002); Jefferson v. Lead
Indus.

Ass’n,

Inc.,

930

F.

Supp.

241,

245

(E.D.

La.

1996)

(Vance, J.). Plaintiff asserts that Seroquel, Seroquel XR, and
their generics are unreasonably dangerous for all four reasons
listed above. In its Motion to Dismiss, AstraZeneca challenges
the sufficiency of Plaintiff’s allegations with respect to (1)

7

construction

or

composition,

(2)

design,

and

(3)

breach

of

express warranty.
A. Unreasonably Dangerous in Construction or Composition
A

product

is

unreasonably

dangerous

in

construction

or

composition if it deviates materially from “the manufacturer's
specifications or performance standards for the product or from
otherwise

identical

products

manufactured

by

the

same

manufacturer.” LA. REV. STAT. § 9:2800.55. In these cases, the
defect is not inherent in all units of the same product. Brocato
v. DePuy Orthopaedics, Inc., No. 14-2607, 2015 WL 854150, at *3
(E.D. La. Feb. 25, 2015) (Shushan, Mag.). Instead, a “mistake in
the manufacturing process” renders the product defective. Id.;
see also Stahl, 283 F.3d at 263. In order to survive a motion to
dismiss,

the

product

either

standards

or

claimant

must

deviated

from

demonstrate
the

specifications

that

defendant’s

or

from

the
own

particular
performance

identical

products

manufactured by the defendant. See Brocato, 2015 WL 854150, at
*3.
In her amended complaint, Plaintiff fails to demonstrate
that

the

particular

drugs

she

took

materially

deviated

from

AstraZeneca’s own standards or specifications or from identical
products

manufactured

by

AstraZeneca.
8

Plaintiff

alleges

that

“AstraZeneca’s

specifications

or

performance

standards

for

Seroquel are that it is an effective, safe medicine for the
treatment of bipolar disorder.” (Rec. Doc. 21, at 24.) Assuming
without

deciding

that

this

statement

sufficiently

alleges

a

specification or standard, Plaintiff still does not claim that
the particular drugs she took deviated from these standards or
specifications.

Instead,

Plaintiff

argues

that

all

units

of

Seroquel deviated from this standard. Id. (“Seroquel does not
work as it was intended . . . and instead creates medical [sic]
severe and life threatening problems.”) Because Plaintiff failed
to allege a defect in the particular products she used, her
construction or composition claim fails to satisfy the minimal
pleading standard.
B. Unreasonably Dangerous in Design
Plaintiff

also

alleges

that

Seroquel,

Seroquel

XR,

and

their generics are unreasonably dangerous in design. Under the
LPLA, a product is unreasonably dangerous in design if:
(1) There existed an alternative design for the
product that was capable of preventing the claimant's
damage; and
(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. An adequate warning about a
product
shall
be
considered
in
evaluating
the
9

likelihood of damage when the manufacturer has used
reasonable care to provide the adequate warning to
users and handlers of the product.
LA. REV. STAT. § 9:2800.56. To state a claim for unreasonably
dangerous design, the plaintiff must (1) allege how the design
is defective or how the design relates to the injury and (2)
demonstrate the existence of a specific alternate design. Becnel
v. Mercedes-Benz USA, LLC, No. 14-0003, 2014 WL 4450431, at *4
(E.D. La. Sept. 10, 2014) (Barbier, J.); see Kennedy v. Pfizer,
Inc., No. 12-01858, 2013 WL 4590331, at *4 (W.D. La. Aug. 28,
2013) (Hicks, J.).
The

occurrence

of

an

injury

does

not

give

rise

to

the

presumption that the design was unreasonably dangerous. Kennedy,
2013

WL

4590331,

at

*3.

A

conclusory

allegation

that

an

alternate design exists will not suffice, but the plaintiff need
not allege in detail “that the product's design would cause the
claimant's damage,” that “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.” Becnel, 2014 WL 4450431,
at

*4

(finding

defendant

used

sufficient
an

plaintiff’s

alternative

design

implementing the new, defective design).
10

allegations
in

the

that

past

the

before

In this case, Plaintiff failed to demonstrate the existence
of a specific alternative design. Instead, the amended complaint
alleges

the

medicines

existence

and

of

“numerous

prescription

over

medications

the

counter

whose

[sic]

patents

have

expired that could have been manufactured and/or utilized to
treat plaintiff’s symptoms.” (Rec. Doc. 21, at 25.) Plaintiff
also argues that AstraZeneca manufactured other products that
could have been used to treat her symptoms. Id. Both allegations
are
does

insufficient
not

because

demonstrate

the

the

existence

existence

of

of

a

alternate
specific

products
alternate

design. Finally, the complaint does not allege how the design is
defective or how the design relates to her injuries. See id. at
25-26 (defective design allegations). Thus, Plaintiff failed to
state a claim for unreasonably dangerous design under the LPLA.
C. Unreasonably Dangerous Due to Breach of Express Warranty
Finally, AstraZeneca argues that Plaintiff failed to state
a

claim

for

breach

of

express

warranty

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

claimant

or

another person or entity to use the product and the claimant's
damage was proximately caused because the express warranty was
11

untrue.” LA. REV. STAT. § 9:2800.58. Thus, the

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 warranty, and (4) the plaintiff’s damage
was proximately caused because the express warranty was untrue.”
Caboni v. Gen. Motors Corp., 278 F.3d 448, 452 (5th Cir. 2002).
To

state

a

claim

for

breach

of

express

warranty,

the

plaintiff must (1) allege the content of the warranty and (2)
explain how the warranty was untrue. Henderson v. Dasa, No. 138, 2014 WL 1365968, at *3 (E.D. La. Apr. 7, 2014) (Milazzo, J.).
The complaint need not “identify specific language offered by a
manufacturer,” but it must “specify the warranty in question”
and

explain

4450431,

at

why
*5;

the

warranty

Kennedy,

2013

was
WL

untrue.
4590331,

Becnel,
at

*5.

2014
The

WL
LPLA

defines an 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.” LA. REV. STAT. § 9:2800.58(6). Statements
contained

in

advertising

or
12

websites

generally

are

not

warranties

because

they

are

“puffery,”

“general

praise,”

or

“general opinion.” Becnel, 2014 WL 4450431, at *5; see LA. REV.
STAT. § 9:2800.58(6).
Here,

Plaintiff

alleges

that

AstraZeneca

expressly

warranted “that Seroquel is a safe, effective product that can
be

used

for

disorder.”

the

treatment

(Rec.

Doc.

21,

of

depressive

at

20.)

episodes

According

to

of

bipolar

Plaintiff,

AstraZeneca made these warranties in “its materials presented to
the FDA, its website[,] and upon information and belief[,] its
marketing,
plaintiff,

promotional[,]
patients,

psychologists.”

Id.

and

plaintiff’s
at

19-20.

informational
doctors,
Any

materials

[and]

to

plaintiff’s

statements

made

on

AstraZeneca’s website or in its marketing materials were not
warranties – they were mere puffery, praise, or opinion. Becnel,
2014 WL 4450431, at *5. Further, Plaintiff fails to specify the
“materials presented to the FDA” in which the alleged warranties
appear. While Plaintiff is not required to quote the specific
language of the warranties, she must make more than a general
reference to them. Id. The reference to “materials presented to
the

FDA”

is

not

specific

enough

motion to dismiss.

13

to

survive

a

Rule

12(b)(6)

CONCLUSION
Accordingly,
IT IS HEREBY ORDERED that AstraZeneca’s Motion to Dismiss
(Rec. Doc. 23) is GRANTED. AstraZeneca’s Motion for Leave to
File Reply (Rec. Doc. 38) is DENIED as moot.
IT IS FURTHER ORDERED that Plaintiff’s claims, with the
exception

of

her

Failure

to

Warn

claim,

are

DISMISSED

WITH

PREJUDICE. Plaintiff’s request for leave to amend her complaint
is DENIED.
IT IS FURTHER ORDERED that oral argument on this matter,
set for October 7, 2015, at 9:30 a.m., is CANCELED.
New Orleans, Louisiana this 6th day of October, 2015.

CARL J. BARBIER
UNITED STATES DISTRICT COURT

14