Small et al v. Amgen, Inc. et al
Filing
66
OPINION AND ORDER granting in part and denying in part 55 Defendants' Motion to Dismiss. Count IV is dismissed in part to the extent that plaintiffs assert a claim for the negligent failure to test or inspect, and to the extent that plaintiffs assert a claim of negligence per se. The motion is otherwise denied. See Opinion and Order for details. Signed by Judge John E. Steele on 3/6/2014. (MAB)
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
FORT MYERS DIVISION
REBECCA
A.
SMALL
LAWRENCE W. SMALL
and
Plaintiffs,
v.
Case No: 2:12-cv-476-FtM-29DNF
AMGEN, INC., PFIZER, INC.,
and WYETH, INC.,
Defendants.
OPINION AND ORDER
This matter comes before the Court on review of defendants’
Motion to Dismiss (Doc. #55) filed on May 17, 2013.
Plaintiffs
filed a Response in Opposition (Doc. #59) on June 14, 2013.
Defendants
filed
a
Reply
(Doc.
#62)
on
June
28,
2013,
and
plaintiffs filed a Sur-Reply (Doc. #65) on July 5, 2013.
I.
Under Federal Rule of Civil Procedure 8(a)(2), a Complaint
must contain a “short and plain statement of the claim showing
that
the
8(a)(2).
pleader
This
is
entitled
obligation
to
relief.”
“requires
more
Fed.
R.
Civ.
than
labels
P.
and
conclusions, and a formulaic recitation of the elements of a
cause of action will not do.”
Bell Atl. Corp. v. Twombly, 550
U.S. 544, 555 (2007)(citation omitted).
To survive dismissal,
the factual allegations must be “plausible” and “must be enough
to raise a right to relief above the speculative level.”
Id. at
555.
See also Edwards v. Prime Inc., 602 F.3d 1276, 1291 (11th
Cir.
2010).
This
requires
“more
than
an
defendant-unlawfully-harmed-me accusation.”
unadorned,
the-
Ashcroft v. Iqbal,
556 U.S. 662, 678 (2009)(citations omitted).
In deciding a Rule 12(b)(6) motion to dismiss, the Court
must accept all factual allegations in a complaint as true and
take them in the light most favorable to plaintiff, Erickson v.
Pardus, 551 U.S. 89 (2007), but “[l]egal conclusions without
adequate
factual
truth,”
Mamani
support
v.
are
Berzain,
2011)(citations omitted).
entitled
654
F.3d
to
1148,
no
assumption
1153
(11th
of
Cir.
“Threadbare recitals of the elements
of a cause of action, supported by mere conclusory statements,
do not suffice.” Iqbal, 556 U.S. at 678.
“Factual allegations
that are merely consistent with a defendant’s liability fall
short of being facially plausible.”
Chaparro v. Carnival Corp.,
693 F.3d 1333, 1337 (11th Cir. 2012) (internal quotation marks
and citations omitted).
Thus, the Court engages in a two-step
approach: “When there are well-pleaded factual allegations, a
court should assume their veracity and then determine whether
they plausibly give rise to an entitlement to relief.”
556 U.S. at 679.
2
Iqbal,
II.
On August 29, 2012, plaintiffs Rebecca and Lawrence Small
filed a six count complaint against Amgen, Inc., Wyeth, Inc.,
Pfizer, Inc., and Does 1-20. 1
Plaintiffs amended their complaint
on October 30, 2012, but it was subsequently dismissed as an
impermissible shotgun pleading.
(Doc. #53.)
Plaintiffs are now
relying on their Fourth Amended Complaint which sets forth the
following five claims based on injuries allegedly caused by the
prescription drug Enbrel: (I) strict liability based on a design
defect; (II) strict liability based on a failure to warn; (III)
breach of an express warranty; (IV) negligence; and (V) loss of
consortium.
(Doc.
#54.)
In
support,
plaintiffs
allege
the
following:
The prescription drug Enbrel is a “biologic” drug used to
treat rheumatoid arthritis. 2
(Doc. #54, ¶¶ 15, 19.)
Enbrel was
originally developed by Amgen and, at all relevant times, the
drug was marketed and sold by both Amgen and Wyeth.
17.)
(Id. ¶¶ 16-
On October 15, 2009, Wyeth was acquired by Pfizer.
(Id ¶
18.)
1Does
1-20, unknown defendants, are no longer parties to
this action.
2A
“biologic” drug is a medicine that has been constituted
or reconstituted from natural substances in the body.
(Doc.
#54, ¶ 15.)
3
In
2002,
Ms.
Small
began
receiving
two
subcutaneous
injections of Enbrel a week to treat her rheumatoid arthritis.
(Id. ¶ 22.)
Ms. Small continued the treatment until August 29,
2008, when she was admitted to the hospital on an emergency
basis
and
was
diagnosed
with
a
perforated
bowel
from
a
diverticulitis infection that was caused by her use of Enbrel.
Until
a
few
days
asymptomatic.
infection.
before
her
hospitalization,
Ms.
Small
was
Multiple surgeries were required to treat the
(Id. ¶ 26.)
Following her release from the hospital, Ms. Small visited
her rheumatologist, Dr. Catherine Kowal.
Dr. Kowal consulted
with a sales representative regarding Enbrel and was ensured by
the representative that it was appropriate to resume Ms. Small’s
treatment with Enbrel three months after the serious adverse
effects occurred.
round
of
(Id. ¶ 27.)
complications
Ms. Small experienced another
associated
with
her
requiring additional surgeries and treatment.
use
of
Enbrel
(Id. ¶ 28.)
At no time prior to Ms. Small’s injuries were doctors and
patients
warned
infections.
that
Enbrel
could
cause
asymptomatic
serious
The label accompanying Enbrel at the time of Ms.
Small’s injuries included the following boxed warning:
Infections, including serious infection leading to
hospitalization or death, have been observed in
patients treated with ENBREL® (see WARNINGS and
ADVERSE
REACTIONS).
Infections
have
included
bacterial sepsis and tuberculosis. Patients should be
4
educated about the symptoms of infection and closely
monitored for signs and symptoms of infection during
and after treatment with ENBREL®.
Patients who
develop
an
infection
should
be
evaluated
for
appropriate antimicrobial treatment and, in patients
who develop a serious infection, ENBREL® should be
discontinued.
(Id.
¶
29.)
information
In
sheet
addition
or
to
the
medication
boxed
guide
warning,
accompanying
a
patient
the
drug
contained the following instructions to patients:
After starting ENBREL®, if you get an infection, any
signs of an infection including a fever, cough, flulike symptoms, or have any open sores on your body,
call your doctor right away.
ENBREL® can make you
more likely to get infections or make any infection
that you may have worse.
(Id. ¶ 30.)
Although the warnings for Enbrel have mentioned
“infections”
since
Administration
at
(FDA)
least
has
2002,
required
the
that
Food
additional
and
Drug
warnings
covering histoplasmosis and other fungal infections be added to
the label.
(Id. ¶ 37.)
III.
Defendants’
assert
in
their
Motion
to
Dismiss
that
the
Fourth Amended Complaint still constitutes a shotgun pleading,
plaintiffs
were
adequately
effects
of
Enbrel,
support
their
warned
plaintiffs
defective
about
failed
design
to
claim,
the
allege
potential
any
plaintiffs
side
facts
to
failed
to
identify an express warranty, and plaintiffs failed to identify
5
any negligent conduct.
(Doc. #55.)
The Court will address each
argument in turn.
A.
Shotgun Pleading
Defendants contend that the Fourth Amended Complaint still
constitutes a shotgun pleading because plaintiffs simply removed
the language incorporating the preceding paragraphs into each
count and replaced it with a section titled “Factual Allegations
Relevant
to
All
Causes
of
Action.”
In
response,
plaintiffs
argue that the Fourth Amended Complaint does not constitute a
shotgun pleading because the offending language was removed and
the facts are relevant to all of their claims.
A
typical
“incorporate[s]
each
subsequent
shotgun
every
claim
pleading
antecedent
for
is
a
allegation
relief
or
by
pleading
that
reference
into
affirmative
defense.”
Wagner v. First Horizon Pharm. Corp., 464 F.3d 1273, 1279 (11th
Cir. 2006).
A complaint incorporating a long list of general
allegations into each claim for relief will also constitute a
shotgun pleading if it fails to specify which facts are relevant
to each claim.
Johnson Enters. of Jacksonville, Inc. v. FPL
Group, Inc., 162 F.3d 1290, 1333 (11th Cir. 1998).
The problem
with a shotgun complaint is that most of the counts “contain
irrelevant
factual
allegations
and
legal
conclusions.”
Strategic Income Fund, L.L.C. v. Spear, Leeds & Kellogg Corp.,
305 F.3d 1293, 1295 (11th Cir. 2002); see also Anderson v. Dist.
6
Bd. of Trs. of Cent. Fla. Cmty. Coll., 77 F.3d 364, 366 (11th
Cir. 1996) (The general problem with shotgun pleadings is that
“it is virtually impossible to know which allegations of fact
are intended to support which claim(s) for relief.”)
The Eleventh Circuit has routinely and explicitly condemned
“shotgun pleadings,” Davis v. Coca-Cola Bottling Co. Consol.,
516 F.3d 955, 979 n.54 (11th Cir. 2008), and has stated that
neither the district courts nor the defendants are required to
“sift through the facts presented and decide for itself which
were
material
to
the
particular
cause
of
action
asserted.”
Beckwith v. Bellsouth Telecomms. Inc., 146 F. App’x 368, 372
(11th Cir. 2005) (quoting Strategic Income Fund, LLC v. Spear,
Leeds & Kellogg Corp., 305 F.3d 1293, 1296 n.9 (11th Cir. 2002)
(citations omitted)).
The Fourth Amended Complaint is far from exemplary, but
does
not
amount
to
an
impermissible
shotgun
pleading.
The
problem with a shotgun pleading is that each subsequent count is
replete
with
conclusions.
general
irrelevant
factual
allegations
and
legal
Here, the complaint simply contains a section of
factual
allegations
plaintiffs’ claims.
that
are
relevant
to
all
of
The legal conclusions are not incorporated
into each subsequent count.
Given that all of the claims are
based upon Ms. Small’s use of Enbrel, the Court finds that the
use of general factual allegation section is not problematic.
7
Therefore,
defendants’
motion
to
dismiss
the
Fourth
Amended
Complaint as a shotgun pleading is denied.
B.
Count I: Strict Liability – Defective Design
In order to state a claim in Florida for strict products
liability,
a
plaintiff
must
allege
(1)
the
manufacturer’s
relationship to the product in question, (2) the unreasonably
dangerous condition of the product, and (3) the existence of a
proximate causal connection between such condition the user’s
injuries or damages.
Bailey v. Janssen Pharmaceutica, Inc., 288
F. App’x 597, 604 (11th Cir. 2008) (citing West v. Caterpillar
Tractor Co., 336 So. 2d 80, 87 (Fla. 1976).
Defendants contend
that Count I should be dismissed because plaintiffs have failed
allege a single fact in support of the products unreasonably
dangerous condition.
The Court disagrees.
Plaintiffs allege that “Enbrel® contained an unreasonably
dangerous defect in design or formulation in that, when it left
the
hands
of
the
Defendants,
an
average
consumer
could
not
reasonably anticipate the dangerous nature of Enbrel® nor fully
appreciate
Enbrel®.”
the
attendant
(Doc. #54, ¶ 46.)
risk
of
injury
associated
with
Plaintiffs further allege that Ms.
Small experienced severe and significant infections due to the
design defect.
(Id. ¶¶ 23, 49-50.)
The Eleventh Circuit has
observed that “[t]he very nature of a products liability actionwhere the cause or source of the defect is not obvious to the
8
consumer-would make it difficult for [a plaintiff] to pinpoint a
specific source of defect against one entity along the chain of
distribution prior to discovery.”
Although
plaintiffs
do
not
set
Bailey, 288 F. App’x at 605.
forth
the
precise
chemical,
biological, or other process by which Enbrel causes asymptomatic
infections, they do place defendants on notice of the type of
harm allegedly caused by the design defect.
the
proceedings,
the
Court
finds
that
At this stage of
the
allegations
of
an
unreasonably dangerous defect are sufficient to plausibly state
a strict liability claim based on a design defect.
288 F. App’x at 608.
See Bailey,
Therefore, defendants’ motion to dismiss
Count I of the Fourth Amended Complaint is denied.
C.
Count II: Strict Liability - Failure to Warn
“As a general rule, drug companies have the duty to warn of
a drug’s dangerous side effects; however, the duty to warn is
directed to physicians rather than patients under the ‘learned
intermediary’ doctrine.”
Hoffmann-La Roche, Inc. v. Mason, 27
So. 3d 75, 77 (Fla. 5th DCA 2009) (citing Felix v. Hoffmann-La
Roche, Inc., 540 So. 2d 102, 104 (Fla. 1989)).
The duty to warn
is satisfied if the drug manufacturer gives an adequate warning
to the physician who prescribes the drug.
Buckner v. Allegran
Pharms, Inc., 400 So. 2d 820, 822 (Fla. 5th DCA 1981).
In
determining the adequacy of a warning, the critical inquiry is
whether it was adequate to warn the physician of the possibility
9
that the drug may cause the injury alleged by the plaintiff.
Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683 (Fla. 1990).
sufficiency
and
reasonableness
of
a
warning
is
The
generally
a
question of fact, but “can become a question of law where the
warning is accurate, clear, and unambiguous.”
Felix, 540 So. 2d
at 105.
Plaintiffs allege that defendants failed to adequately warn
health
care
increased
providers
risk
of
that
Enbrel
complications
was
associated
arising
from
with
serious
an
and
significant infection and failed to adequately instruct doctors
and
patients
asymptomatic
how
to
mitigate
infections,
(Doc. #54, ¶¶ 54, 56.)
risks
associated
of
infections,
with
the
use
including
of
Enbrel.
Defendants contend that Packaging Insert
accompanying Enbrel was adequate as a matter of law because it
broadly and clearly warned Ms. Small’s physician of the risk of
infection.
In support of their position, defendants rely on
Salvio v. Amgen, Inc., No. 2:11-cv-00553, 2012 WL 517446 (W.D.
Pa. Feb. 15, 2012).
In Salvio, the court dismissed a failure to
warn claim brought under Pennsylvania law because it determined
that
the
adequately
“broad”
warned
warning
the
of
infection
decedent’s
doctors
accompanying
of
the
occurred, a serious infection resulting in death.
Enbrel
injury
that
Id. at *5-6.
Defendants requests that this Court follow the holding in Salvio
by
finding
that
the
broad
warning
10
of
infection
accompanying
Enbrel adequately warned Ms. Small’s physicians of the risk of a
serious asymptomatic infection.
A review of the warning label reveals that it not only
provides
a
includes
broad
and
warnings
general
warning
regarding
of
specific
infection,
types
of
but
also
infections
(“Infections have included bacterial sepsis and tuberculosis”).
Because
the
warning
asymptomatic
label
infections,
does
however,
not
specifically
the
Court
finds
warn
of
that
a
determination as to the adequacy of such a broad warning of
infection is best left for a later stage of the proceedings.
Plaintiffs
have
plausibly
stated
a
cause
of
action.
Accordingly, defendants’ motion to dismiss Count II is denied.
D.
Count III: Breach of Express Warranty
Defendants
assert
that
plaintiffs’
breach
of
express
warranty claim should be dismissed because it is conclusory in
nature.
The Court disagrees.
An express warranty is “[a]ny
affirmation of fact or promise made by the seller to the buyer
which
relates
bargain[.]”
to
Fla.
the
goods
Stat.
§
and
becomes
672.313(1)(a).
a
basis
of
the
However,
“an
affirmation merely of the value of the goods or a statement
purporting to be merely the seller’s opinion or commendation of
the goods does not create a warranty.”
Fla. Stat. § 672.313(2).
The existence of an express warranty is a factual issue for the
11
jury to decide.
State Farm Ins. Co. v. Nu Prime Roll-A-Way of
Miami, 557 So. 2d 107, 109 (Fla. 3d DCA 1990).
Plaintiffs
the
package
allege
inserts,
that
the
defendants
expressly
Physicians’
Desk
warranted
Reference,
in
other
marketing literature, and documents provided to the FDA, that
Enbrel was of merchantable quality, fit, safe, and otherwise not
injurious to the health and well-being of Ms. Small. 3
¶ 66.)
(Doc. #54,
Plaintiffs further allege that these representations
were material to Ms. Small’s decision to use Enbrel and that
product did not conform to the representations.
the product’s nonconformity, she was injured.
The
Court
plausibly
finds
state
that
a
claim
these
for
allegations
breach
of
an
As a result of
(Id. ¶¶ 67-71.)
are
sufficient
express
to
warranty.
Therefore, defendants’ motion to dismiss Count III of the Fourth
Amended Complaint is denied.
E.
Count IV: Negligence
In order to state a claim for negligence under Florida law,
the plaintiff must allege (1) a duty or obligation recognized by
the
law
requiring
the
defendant
3In
to
protect
others
from
response to defendants’ motion to dismiss, plaintiffs
attempt to include the promises made by defendants’ sales
representative in their breach of express warranty claim.
Plaintiffs, however, have failed to include any allegations
regarding
the
representative’s
promises
in
Count
III.
Accordingly, the Court declines to include them among the
alleged warranties.
12
unreasonable risks; (2) a breach of that duty; (3) a reasonably
close casual connection between the conduct and the resulting
injury; and (4) actual loss or damages.
So.
2d
1052,
1056
(Fla.
2007)
(citing
Williams v. Davis, 974
Clay
Johnson, 873 So. 2d 1182, 1185 (Fla. 2003)).
Elec.
Corp.
v.
Here, plaintiffs
allege that “Defendants failed to exercise ordinary care in the
design,
formulation,
manufacture,
sale,
testing,
quality
assurance, quality control, labeling, marketing, promotions and
distribution of Enbrel® . . . .”
(Doc. #54, ¶ 74.)
Defendants
assert that there is not a single fact in the Fourth Amended
Complaint to support the assertion that Enbrel was negligently
designed or manufactured. 4
For the reasons set forth in Section
3.B above, the Court finds that plaintiffs have plausibly stated
a claim for a design defect, and for the same reasons, the Court
finds that the allegations are sufficient to support a claim of
negligent manufacturing.
See Hosler v. Alcon Labs., Inc., No.
12-60025-CIV, 2012 WL 4792983, at *6 (M.D. Fla. Oct. 9, 2012)
(citing Bailey, 288 F. App’x at 605).
Defendants also assert
that a claim for negligent testing is subsumed by plaintiffs’
claims for defective design and failure to warn.
4Defendants
To this the
also assert that the negligent failure to warn
claim fails under the learned intermediary doctrine, but, as
discussed above, the Court is unable to determine if the warning
label is adequate as a matter of law. Therefore, plaintiffs may
proceed on their negligent failure to warn claim.
13
Court agrees.
testing
or
In Florida, no separate duty or claim exists for
inspecting
a
product
because
it
is
part
of
the
manufacturer’s duty to design a product with reasonable care;
thus, it is subsumed in claims for defective design and failure
to warn.
Hall v. Sunjoy Indus. Grp., Inc., 764 F. Supp. 2d
1297, 1302 (M.D. Fla. 2011) (citing Adams v. G.D. Searle & Co.,
Inc., 576 So. 2d 728, 730-31 (Fla. 2d DCA 1991)).
plaintiffs’
claim
for
negligence
cannot
rest
Accordingly,
on
defendants’
alleged failure to test or inspect.
Plaintiffs also allege that defendants breached the duty of
pharmacovigilance,
which
includes
the
duties
to
continually
monitor, test, and analyze data regarding the safety, efficacy,
and prescribing practices of Enbrel.
(Doc. #59, ¶¶ 85-86.)
In
support of the alleged breach, plaintiffs assert that defendants
learned through clinical trials and adverse event reports that
there was a serious problem associated with Enbrel, but failed
to
adequately
inform
public of the risk.
doctors,
regulatory
(Id. ¶ 86.)
defendants’
failure
to
requirements
of
regulations
FDA
comply
agencies,
and
the
Plaintiffs further allege that
with
is
the
post
evidence
negligence and also constitutes negligence per se.
of
marketing
defendants’
(Id. ¶ 91.)
Defendants contend that plaintiffs cannot assert a claim of
negligence per se for the failure to comply with FDA regulations
because Florida law does not recognize a claim for negligence
14
per se for the alleged violation of the Federal Food, Drug, and
Cosmetic
Act
(FDCA).
District
courts
in
this
Circuit
have
consistently held that private actions based on the violation of
FDA regulations are barred because Florida does not recognize
such causes of action.
Supp.
2d
1187,
1192
Kaiser v. Depuy Spine, Inc., 944 F.
(M.D.
Fla.
2013).
See
also
Cook
v.
MillerCoors, LLC, 872 F. Supp. 2d 1346, 1351 (M.D. Fla. 2012).
Thus, Count IV is dismissed to the extent that plaintiffs assert
a
negligence
per
se
claim
based
on
defendants’
alleged
violations of FDA regulations.
Accordingly, it is now
ORDERED:
Defendants’ Motion to Dismiss (Doc. #55) is GRANTED in part
and DENIED in part.
Count IV is dismissed in part to the extent
that plaintiffs assert a claim for the negligent failure to test
or inspect, and to the extent that plaintiffs assert a claim of
negligence per se.
The motion is otherwise denied.
DONE AND ORDERED at Fort Myers, Florida, this
of March, 2014.
Copies:
Counsel of record
15
6th
day
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