Houston v. Bayer Healthcare Pharmaceuticals, Inc.

Filing 12

MEMORANDUM OPINION. Signed by Judge William M Acker, Jr on 3/28/14. (ASL)

FILED
2014 Mar-28 PM 04:06
U.S. DISTRICT COURT
N.D. OF ALABAMA

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ALABAMA
SOUTHERN DIVISION
SHENIKA HOUSTON,

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Plaintiff,
v.
BAYER HEALTHCARE
PHARMACEUTICALS, INC.,
Defendant.

CIVIL ACTION NO.
2:14-cv-00035-WMA

MEMORANDUM OPINION
Before the court is the motion of defendant Bayer Healthcare
Pharmaceuticals, Inc, to dismiss this action pursuant to Federal
Rule of Civil Procedure 12(b)(6). For the reasons that follow, the
motion will be granted as to plaintiff’s implied warranty claim,
but denied as to all other claims.
Background
For

purposes

of

this

opinion,

complaint are taken as true.

all

facts alleged

in

the

Plaintiff is a 26-year-old woman

seeking to recover damages for injuries she alleges were caused by
Mirena, a birth control device manufactured by defendant.

Mirena

is a physical device placed in the uterus for up to five years.
Compl.

¶

19.

It

regularly

releases

“levonorgestral,”

prescription medication, directly into the uterus.

a

Id. ¶¶ 13, 17.

It is used for birth control, id. ¶ 17, and “for treatment of heavy
menstrual

bleeding

in

women

who
1

choose

to

use

intrauterine

contraception as their method of contraception,” id. ¶ 15.
According to plaintiff, the levonorgestral released by Mirena
has been linked to development of a condition called “pseudotumor
cerebri,” also known as “idiopathic intracranial hypertension,”
(hereinafter, “PTC/IIH”).
builds up in the skull.
migraine-like
vision),

Id. ¶ 27.

headaches

temporary

Id. ¶ 26.

with

It causes “severe migraines or

blurred

blindness,

PTC/IIH occurs when fluid

blind

vision,

diplopia

spots,

or

other

(double
visual

deficiencies,” id. ¶ 28, and “‘whooshing’ or ringing in the ear,
clinically called tinnitus,” id. ¶ 29.

If not corrected diagnosed

and treated, it “may lead to permanent vision loss and even
blindness.” Id. ¶ 34. PTC/IIH is treatable, but positive outcomes
are not assured.
Plaintiff

Id. ¶¶ 35-44.
used

the

Mirena

device,

id.

subsequently diagnosed with PTC/IIH, id. ¶ 72.

¶

70,

and

was

She brings this

action seeking recovery for her injuries under nine state law
causes of action.

The court has diversity jurisdiction under 28

U.S.C. § 1332 because the amount in controversy exceeds $75,000,
and because defendant is a citizen of New Jersey and plaintiff is
a citizen of Alabama.
Defendant now moves the court, pursuant to Federal Rule of
Civil Procedure 12(b)(6), for dismissal of this case for failure to
state a claim.

2

Analysis
Under the standard provided by Bell Atl. Corp. v. Twombly, 550
U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009), a
motion

to

dismiss

under

“two-pronged approach.”

Rule

12(b)(6)

Id. at 679.

is

analyzed

using

First, the court sifts out

and discards all of the legal conclusions from the complaint.
id. at 678.

a

See

Second, the court determines whether what is left

states a “plausible” claim for relief.

See id. at 679.

Defendant

argues that under this standard, the complaint in this case is so
glaringly deficient that it must be dismissed in its entirety.

In

the alternative, defendant argues that each of plaintiff’s claims
suffers some individual defect that requires its dismissal.
A.

“Global Deficiency”

Defendant first argues that the complaint contains so few
facts as to deprive defendant of fair notice of what it is being
sued for.

See Def.’s Mem. at 3-4; Def.’s Reply at 2-4 (arguing

complaint is “so globally deficient” that it must be dismissed in
its entirety, without analysis of any individual cause of action).
As an initial matter, the court disagrees that there exists an
abstract sufficiency hurdle, contained in the Federal Rule, that is
entirely separate from any substantive law. So long as a plaintiff
lists some cause of action in his complaint, the question is
whether he has alleged facts to support that cause of action, not
simply whether he has alleged facts.
3

Indeed, the second prong of

the Iqbal test, in which the court determines whether the complaint
states a plausible claim for relief, requires by logical necessity
some discussion of the elements of the causes of actions alleged.
See 556 U.S. at 675 (“In Twombly, the Court found it necessary
first

to

complaint.

discuss

the

antitrust

principles

implicated

by

the

Here too we begin by taking note of the elements a

plaintiff must plead to state a claim . . . .”); Resnick v. AvMed,
Inc., 693 F.3d 1317, 1325 (11th Cir. 2012) (“First, we determine
what must be pled for each cause of action.”) (collecting state
court cases to establish the elements of the causes of action at
issue).
The only case from this district cited by defendandant in
support of its “global deficiency” theory, Weldon v. Washington
Nat. Ins. Co., 2:13-CV-02209-RDP, 2014 WL 130486 (N.D. Ala. Jan.
14, 2014), is not to the contrary of this principle.

There the

court specifically couched its dismissal of the action in terms of
the elements of the causes of action alleged by the plaintiff.

See

id. at *2 (“Plaintiff not only neglects to outline the elements of
the claims he asserts (i.e., negligence and wantonness), but he
also fails to articulate any factual allegations that relate to
those

elements,

such

as

facts

regarding

Defendant's

alleged

negligence or Defendant's allegedly wrongful denial of Plaintiff's
insurance

claim.”).

Equally

unpersuasive

is

Bosch

v.

Bayer

Healthcare Pharm., Inc., 3:13-CV-00656-JHM, 2013 WL 5656111 (W.D.
4

Ky. Oct. 16, 2013), the case on which defendant primarily relies.
Bosch, an unpublished decision from a different district, has no
holding that this court can discern, as the court there declined to
analyze the complaint before it on the grounds that doing so would
provide the plaintiffs an advisory opinion.

See id. at *4 (“The

Court notes that it is neither necessary nor desirable for it to
detail the deficiencies in Plaintiffs' complaint.”).

The reason

for this curious coyness must be derived from the court’s final
disposition on the motion to dismiss. The court reserved ruling on
the

motion,

and

ordered

the

plaintiffs

to

file

an

amended

complaint, even without plaintiffs’ having moved to do so. Because
“[t]he case [was] still in its earliest stages,” and because the
court for whatever reason found the complaint hopeless, the court
thought it most fair and efficent to simply re-start the case with
a more detailed complaint before providing any meaningful analysis
of the merits of the case.

Id. at *3.

It does not follow from

this unique disposition, as defendant seems to believe, that a case
can be dismissed outright, with prejudice, without any analysis of
the elements of a plaintiff’s claims.
Even were such a “global deficiency” principle to exist, the
court takes with healthy skepticism defendant’s claim that it has
no notice here as to why it is being sued.

The opening sentence of

the complaint spells out that plaintiff seeks redress for “personal
injuries suffered as a proximate result of [p]laintiff being
5

prescribed

and

properly

using

the

dangerous product Mirena . . . .”

defective

Compl. at 1.

and

unreasonably

Later, plaintiff

explains simply that she “had the Mirena IUS inserted into her
body,” Compl. ¶ 70; that she subsequently became ill and “was
ultimately diagnosed with [PTC/IIH],” id. ¶ 73; and that there
exists some evidence that the disease was caused by the Mirena, id.
¶

74;

see

id.

¶¶

46-60

(evidence

levonorgestrel and PTC/IIH).

of

possible

link

between

Finally, the complaint names and

spells out eight causes of action, Compl. ¶¶ 76-189, so that
defendant knows exactly where it needs to focus its attention as
the case moves to the discovery phase. The complaint thus contains
the “short and plain statement of the claim,” Fed. R. Civ. P.
8(a)(2), and the “demand for the relief sought,” 8(a)(3), required
by the Federal Rules.
B.

Missing Elements

While the complaint has not earned any general dismissal for
“global deficiency,” it must still contain factual allegations
sufficient to satisfy the elements of each individual claim.

The

court finds that plaintiff has failed to state a claim for breach
of

implied

warranty,

but

that

her

other

claims

all

survive

defendant’s motion to dismiss.
1.

Breach of Implied Warranty

Defendant’s sole winning argument is that plaintiff fails to
state a claim for Breach of Implied Warranty (plaintiff’s Count
6

IV).

Implied warranties are covered by the Alabama Commercial

Code.

Under § 7-2-314(1), “a warranty that the goods shall be

merchantable is implied in a contract for their sale if the seller
is a merchant with respect to goods of that kind.”

Under § 7-2-

314(2)(c), “goods to be merchantable must be at least such as . .
. [a]re fit for the ordinary purposes for which such goods are
used.”

Defendant argues that “[p]laintiff does not state facts to

explain how Mirena was not of merchantable quality and unfit for
the ordinary purposes for which it is used, e.g., preventing
pregnancy.”

Def.’s Mem. at 7.

The key to defendant’s argument is

the “e.g., preventing pregnancy” at the end of it.

Defendant

implicitly argues that the Commercial Code implied warranty applies
only when a product fails to accomplish its primary purpose, and
not when the product accomplishes this purpose but has dangerous
side effects.
This question came before the Supreme Court of Alabama, on
certification from the Eleventh Circuit, in Spain v. Brown &
Williamson Tobacco Corp., 872 So. 2d 101 (Ala. 2003).

There, the

administrator of a deceased cigarette smoker’s estate brought suit
against a cigarette manufacturer, including an implied warranty
claim with its wrongful death and design defect tort claims.
at 103.

Id.

The Alabama Supreme Court was called on by the Eleventh

Circuit to answer a number of questions, including whether the
Circuit was correct “that that the sale of cigarettes does not
7

violate the implied warranty of merchantability under Code of
Alabama 1975, § 7–2–314.”

Id. at 103-04.

The Supreme Court’s answer was lengthy and not totally clear.
The Court began by citing its decision in Shell v. Union Oil Co.,
489 So. 2d 569 (Ala. 1986), an implied warranty case against the
manufacturer of a “naptha product” that “contained benzene, a
cancer-causing agent.”

Spain, 872 So. 2d at 106.

In Shell, the

court concluded that “[w]hether this product was unreasonably
dangerous . . . could properly be raised in an action brought under
Alabama's Extended Manufacturer's Liability Doctrine (A.E.M.L.D.),
but not in this U.C.C. action for breach of warranty.”
at 571.

489 So. 2d

The Court reasoned:

The implied warranty mandated by this section of the
U.C.C. is one of commercial fitness and suitability, and
a private right of action is afforded only where the user
or consumer is injured by the breach of that warranty.
That is to say, the U.C.C. does not impose upon the
seller the broader obligation to warrant against health
hazards inherent in the use of the product when the
warranty of commercial fitness has been complied with.
Those injured by the use of or contact with such a
product, under these circumstances, must find their
remedy outside the warranty remedies afforded by the
U.C.C.
Id. at 572 (emphases in original).
This reasoning would seem to answer the question decisively:
the commercial code creates only commercial warranties, not safety
warranties.

However, the Spain court next described a subsequent

case, Allen v. Delchamps, Inc., 624 So. 2d 1065 (Ala. 1993), in

8

which the court reached an apparently opposite result.
So. 2d at 109.

Spain, 872

In Allen, the plaintiff brought an implied warranty

claim, along with AMELD and other tort claims, after having a
reaction

to

chemicals

present

defendant grocery store.

on

celery

purchased

624 So. 2d at 1066-67.

from

the

The Allen court

held, without acknowledging Shell, that AMELD and implied warranty
claims were not mutually exclusive; indeed, “[t]hese two standards
‘go hand-in-hand,’ at least as applied to food products, ‘for it is
apparent that a food product is defective or unreasonably dangerous
if it is unmerchantable or unfit for human consumption.’”

Id. at

1068 (citations omitted).
Without clear explanation, the Spain court concluded from
these cases that “a claim alleging breach of an implied warranty of
merchantability is separate and distinct from an AEMLD claim and is
viable to redress an injury caused by an unreasonably dangerous
product,” and permitted its plaintiff to move forward on the
implied warranty claim.

872 So. 2d at 111.

The best way to

explain the Spain holding is that there is no hard and fast rule
governing the relationship between implied warranty and AEMLD
claims.

The implied warranty analysis “requires a fact-intensive

analysis” separate from any tort claims.

Id. at 108.

The crucial

fact in this “fact-intensive analysis” is what the purpose of the
product at issue is.

When the entire purpose of the product is

simply to be consumed, as was the case with the cigarettes in Spain
9

and the food in Allen, the fact that consumption is dangerous makes
the product unmerchantable.

But when the product has some other

purpose, as did the industrial product in Shell, the implied
warranty applies only to that purpose, and any unreasonable danger
of the product must be addressed by the AMELD or some other theory
of recovery.
The product at issue in this case, the Mirena device, has a
clear function other than consumption.

It is used “for treatment

of heavy menstrual bleeding in women who choose to use intrauterine
contraception as their method of contraception,” Compl. ¶ 15, and
“for birth control,” id. ¶ 17.

The Commercial Code implied

warranty is therefore not breached unless the Mirena fails to
achieve these functions, regardless of what other harms it causes.
That

does

not

mean,

of

course,

that

a

birth

control

device

manufacturer can produce a device with unlimited danger so long as
the device actually prevents pregnancy. It simply means that these
dangers must be addressed by claims under tort theories such as the
AEMLD, rather than under the Commercial Code.

Because the only

Mirena defect that plaintiff alleges in this case is that it
increases the risk of PTC/IIH, plaintiff has not stated a claim for
breach of implied warranty, and the implied warranty count will be
dismissed.
2.

Negligent Design

The remainder of defendant’s criticisms are less successful.
10

Defendant first argues that plaintiff fails to state a claim for
negligent design (plaintiff’s Count I).

Def.’s Mem. at 5-6.

As

the parties agree, negligence has four elements: plaintiff must
provide evidence “that defendant (1) breached (2) a duty, which (3)
proximately caused (4) plaintiff's injury.”

E.R. Squibb & Sons,

Inc. v. Cox, 477 So. 2d 963, 969 (Ala. 1985).

Defendant argues

that these elements are not met because the complaint contains only
legal conclusions which, under the first prong of the Iqbal test,
must be discarded by the court.

See Def.’s Mem. at 6.

For

example, defendant points out, ¶ 80 of the complaint conclusorily
states that “[Mirena] is more dangerous than a reasonably prudent
consumer would expect,” and ¶ 82 states that “[Mirena] was the
proximate cause of the injuries sustained by the Plaintiff.”
Defendant

is

correct

that

these

statements

are

legal

conclusions, and the court will not consider them for purposes of
the motion to dismiss.

But defendant fails to take into account

the many other statements in the complaint that do allege factual
details.

With respect to the duty and breach elements, the

complaint alleges, among other things, that Mirena had “forseeable
risks associated with [its] design or formulation [including] the
development of PTC/IIH, and rapid or sudden weight gain,” Compl. ¶
80; and that “[d]espite an increasing number of [reported health
issues], Defendant has made no effort to warn physicians, the
healthcare

community,

or

patients
11

of

the

risk

of

developing

[PTC/IIH] with Mirena,” Compl. ¶ 90. With respect to the causation
and injury elements, plaintiff recites a medical history of the
levonorgestrel

hormone, stretching back to 1991, that arguably

links the hormone to PTC/IIH.

Id. ¶¶ 46-60.

She combines this

history with the simple statements that she used a Mirena device,
id. ¶ 70, and was subsequently diagnosed with PTC/IIH, id. ¶ 73.
At this early stage of litigation, these allegations are sufficient
to avoid dismissal under Rule 12(b)(6).
Plaintiff meets the test of plausibility.
true

that

one

“implausibility.”

man’s
It

“plausibility”
is

as

slippery

It is, of couse,

is
a

another

word

as

the

man’s
word

“reasonable.” Frankly, a jury is as qualified to determine what is
or is not “plausible.”
3.

Strict Liability/AEMLD Design Defect

Defendant next argues that plaintiff fails to state a claim
for strict liability under the Alabama Extended Manufacturer’s
Liability Doctrine (“AEMLD”) (plaintiff’s Count III).

Under the

AEMLD, a plaintiff can recover under strict liability if he can
show that “he suffered injury or damages to himself or his property
by one who sells a product in a defective condition unreasonably
dangerous to the plaintiff as the ultimate user or consumer, if (a)
the seller is engaged in the business of selling such a product,
and (b) it is expected to and does reach the user or consumer
without substantial change in the condition in which it is sold.”
12

Yamaha Motor Co., Ltd. v. Thornton, 579 So. 2d 619, 621 (Ala.
1991).

It is undisputed here that defendant is engaged in the

business of selling the Mirena device, and that the device was
expected to and did reach plaintiff in the condition that it was
sold.

The only question is whether plaintiff has alleged facts

that “plausibly” show that Mirena is a product “in a defective
condition unreasonably dangerous to the plaintiff.”
Defendant originally argued in its Rule 12(b)(6) motion that
plaintiff “does not identify what aspect of the Mirena design is
allegedly defective.”
disposed of.

Def.’s Mem. at 6.

This argument is easily

Plaintiff alleged that the crucial defect of the

Mirena device is that it “releases levonorgestral, a synthetic
progestogen, directly into the uterus,” Compl. ¶ 17, and that this
increases the risk of developing PTC/IIH, Compl. ¶ 26.

This must

have occurred to defendant shortly after it filed its motion,
because defendant’s argument had changed considerably by the time
it filed its reply brief.

There, it argues that plaintiff has not

alleged a design defect because a Mirena without levonorgestrel
would be an entirely different product.

Def.’s Reply at 4-6.

According to defendant, “[a]n allegation that a defendant should
have manufactured a different product does not state a plausible
design-defect claim.”

Id. at 5.

Plaintiff has had no opportunity to respond to this new
argument, and the motion to dismiss should be denied as to the
13

AEMLD claim for that reason alone.

See United States v. Krasnow,

484 F. App'x 427, 429 (11th Cir. 2012) (“Parties cannot raise new
issues in reply briefs.”) (citing Timson v. Sampson, 518 F.3d 870,
874 (11th Cir.2008)). However, because the result is the same, and
to spare defendant the trouble of advancing the same argument at
the summary judgment stage, the court will consider this argument
in this opinion.
Despite the fact that plaintiff’s claim is based specifically
on a doctrine called the “Alabama Extended Manufacturer’s Liability
Doctrine,” defendant relies exclusively for its argument on cases
applying the design defect laws of New York, Texas, and Louisiana.
See Def.’s Reply at 5.

Regardless of the definitions provided by

those cases, “[f]or purposes of the AEMLD, ‘a ‘defect’ is that
which renders a product ‘unreasonably dangerous,’ i.e., not fit for
its intended purpose.’”

Rudd v. Gen. Motors Corp., 127 F. Supp. 2d

1330, 1333 (M.D. Ala. 2001) (quoting

Casrell v. Altec Indus.,

Inc., 335 So. 2d 128, 133 (Ala. 1976)).

“[I]t makes no difference

whether [a product] is dangerous by design or defect. The important
factor is whether it is safe or dangerous when the product is used
as it was intended to be used.”

Rudd, 127 F. Supp. 2d at 1333

(quoting Casrell, 335 So. 2d at 133) (alterations in Rudd).

In

this

is

case,

plaintiff

has

alleged

that

the

Mirena

device

dangerous when used as it was intended to be used because it
increases the risk of developing PTD/IIH.
14

This allegation is all

that is required for the AEMLD claim to survive defendant’s motion
to dismiss.
4.

Breach of Express Warranty

Defendant next argues the plaintiff has failed to state a
claim for breach of express warranty (plaintiff’s Count V).

The

Alabama Commerical Code provides that an express warranty is
created by “[a]ny affirmation of fact or promise made by the seller
to the buyer which relates to the goods and becomes part of the
basis of the bargain,” § 7-2-313(1)(a), or by “[a]ny description of
the goods which is made part of the basis of the bargain,” § 7-2313(1)(b).

Defendant argues that plaintiff has failed to allege

that any such affirmation of fact, promise, or description was made
about the Mirena device.
Plaintiff has alleged facts to support her express warranty
claim, albeit by the skin of her teeth.

As to the “affirmation of

fact or promise” element, she has alleged that the “designing,
manufacturing,

marketing,

formulating,

testing,

packaging,

labeling, producing, creating, making, constructing, assembling,
and distributing of Mirena were expressly warranted to be safe . .
. for [p]laintiff and members of the public generally.”
153.

Compl. ¶

As to the “part of the basis of the bargain” element, she has

alleged that she “relied on [d]efendant’s representations regarding
Mirena in its package insert . . . in deciding to use . . .
Mirena.”

Id. ¶ 71.

As to the breach element, she has alleged that
15

“Mirena

does

not

conform

to

these

express

warranties

and

representations because Mirena is not safe or effective and may
produce

serious

side

[PTC/IIH] . . . .”

effects,

Id. ¶ 154.

including

the

development

of

Taken as true, these allegations

“plausibly,” in the eyes of this court, state a claim for breach of
express warranty.
5.

Fraud-Based Claims

Finally, defendant argues that plaintiff has failed to state
claims based on fraud under the heightened pleading requirement of
Federal Rule of Civil Procedure 9(b).

These include plaintiff’s

claims for negligent misrepresentation (plaintiff’s Count VI),
fraudulent misrepresenation (plaintiff’s Count VII), and fraud by
suppression and concealment (plaintiff’s Count VIII).

Rule 9(b)

requires that, “[i]n alleging fraud or mistake, a party must state
with

particularity

mistake.”
must

the

circumstances

constituting

fraud

or

In the Eleventh Circuit, this means that “a plaintiff

allege:

‘(1)

misrepresentations

the
made;

precise
(2)

the

statements,
time,

documents,

place,

and

or

person

responsible for the statement; (3) the content and manner in which
these statements misled the Plaintiffs; and (4) what the defendants
gained by the alleged fraud.’”

Am. Dental Ass'n v. Cigna Corp.,

605 F.3d 1283, 1291 (11th Cir. 2010) (citation omitted).

Like the

Iqbal standard, this is not a hard-and-fast test, but can vary
based on the nature of the claim asserted.
16

See Pirelli Armstrong

Tire Corp. Retiree Med. Benefits Trust v. Walgreen Co., 631 F.3d
436, 442 (7th Cir. 2011) (“[B]ecause courts and litigants often
erroneously take an overly rigid view of the formulation, we have
also observed that the requisite information . . . may vary on the
facts of a given case.”).

“Fraud” is a general word that has many

different definitions in many different legal contexts.
whether

a

plaintiff

has

“state[d]

with

Thus,

particularity

the

circumstances constituting fraud,” Fed. R. Civ. Pro. 9(b), depends
on the nature of the “fraud” at issue.
The allegations in this particular complaint meet the 9(b)
standard when viewed in the context of the state law under which
they are brought.
liable

for

fraud

In Alabama, a drug manufacturer “may be held
or

misrepresentation

(by

misstatement

or

omission)” based on “information and warning deficiencies” on a
drug’s labelling.

Wyeth, Inc. v. Weeks, No. 1101397, 2013 WL

135753, at *19 (Ala. Jan. 11, 2013).1

1

The Wyeth court reached this

The Alabama Supreme Court has granted reargument in Wyeth,
but the disposition of the issues under debate in that reargument
will not effect the outcome of this case. In Wyeth, the
plaintiff named as defendant the brand-name manufacturer of the
drug at issue, though he had in fact been injured by a generic
version of the drug produced by a third-party manufacturer. The
Court agreed with plaintiff that liability for the brand-name
manufacturer was appropriate because, under FDA rules, the
generic manufacturer was required to reproduce verbatim the
warning labels of the the brand-name manufacturer. Whether or
not the Supreme Court revisits that holding will not affect the
underlying premise that a failure to provide proper warnings on
drug labeling creates liability for fraud/misprepresentation by
omission.
17

holding even despite defendant’s argument that “the [plaintiff’s]
claims [were], in essence, ‘product-liability’ claims.” Id. at *3.
The Mirena device is not a drug itself, but it works by releasing
a prescription drug into the user’s body.

Compl. ¶ 13.

It also

carries with it the same FDA approval requirements as did the drug
in Wyeth.

Compl. ¶ 14.

here can

base

her

Thus, like the Wyeth plaintiffs, plaintiff

fraud and

misrepresentation

claims

on

the

defendant manufacturer’s breach of its “duty to warn . . . about
the risks associated with the long-term use of the drug” in its
labeling.

Wyeth, 2013 WL 135753, at *2.

Plaintiff

has

stated

a

claim

of

this

kind

with

the

“particularity” required by Rule 9. As to the “precise statements”
requirement and the “time, place, person” requirement, she has
alleged that Mirena comes with a package label that warns about
certain dangers.

Compl. ¶¶ 20-22.

As to the “content and manner

in which the statements misled” requirement, she has alleged that
defendant “owed a duty to provide accurate and complete information
regarding Mirena” on this labeling, id. ¶ 158, and that it breached
this

duty

by

failing

to

warn

about

“the

increased

risk

of

developing PTC/IIH, and the increased risk of suffering severe
consequences due to not removing Mirena once a patient experiences
symptoms of papilledema and/or [PTC/IIH],” id. ¶ 160.

As to the

“what defendants gained” requirement, she has alleged that this
breach of duty induced plaintiff to use the Mirena device.
18

Id. ¶¶

162, 164.

Defendant’s motion to dismiss will therefore be denied

as to plaintiff’s fraud-based claims.
6.

Failure to Warn

Defendant does not argue that plaintiff’s final claim, the
failure to warn claim, (plaintiff’s Count II), is deficient.

The

motion to dismiss will therefore be denied as to this claim.
C.

Amendment

In

a

short,

single

paragraph

at

the

end

of

her

brief,

plaintiff concludes with the request that, “should this [c]ourt
find

any

of

[p]laintiff’s

claims

insufficient,

[p]laintiff

respectfully requests leave to amend her complaint.” Pl.’s Mem. at
27.

As defendant points out, “[w]here a request for leave to file

an amended complaint simply is imbedded within an opposition
memorandum, the issue has not been raised properly.”

Rosenberg v.

Gould, 554 F.3d 962, 967 (11th Cir. 2009) (quoting Posner v. Essex
Ins.

Co.,

178

F.3d

1209,

1222

(11th

Cir.

1999)).

This

is

especially true when, as here, the plaintiff does not bother to
submit or even describe its proposed amendment.

See id.

The court

will therefore deny plaintiff’s non-motion request to amend her
insufficient breach of implied warranty claim.

She has no need to

amend any other claims.
CONCLUSION
For all the foregoing reasons, defendant’s motion to dismiss
will be granted as to plaintiff’s breach of implied and express
19

warranty claims, but denied as to all other claims. The court will
contemporaenously issue an order consistent with this opinion.
DONE this 28th day of March, 2014.

_____________________________
WILLIAM M. ACKER, JR.
UNITED STATES DISTRICT JUDGE

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