Houston v. Bayer Healthcare Pharmaceuticals, Inc.
MEMORANDUM OPINION. Signed by Judge William M Acker, Jr on 3/28/14. (ASL)
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
CIVIL ACTION NO.
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.
complaint are taken as true.
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.
is a physical device placed in the uterus for up to five years.
prescription medication, directly into the uterus.
Id. ¶¶ 13, 17.
It is used for birth control, id. ¶ 17, and “for treatment of heavy
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,”
builds up in the skull.
Id. ¶ 27.
Id. ¶ 26.
It causes “severe migraines or
PTC/IIH occurs when fluid
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.
Id. ¶¶ 35-44.
subsequently diagnosed with PTC/IIH, id. ¶ 72.
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.
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
Id. at 679.
First, the court sifts out
and discards all of the legal conclusions from the complaint.
id. at 678.
Second, the court determines whether what is left
states a “plausible” claim for relief.
See id. at 679.
argues that under this standard, the complaint in this case is so
glaringly deficient that it must be dismissed in its entirety.
the alternative, defendant argues that each of plaintiff’s claims
suffers some individual defect that requires its dismissal.
Defendant first argues that the complaint contains so few
facts as to deprive defendant of fair notice of what it is being
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.
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
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
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.
court specifically couched its dismissal of the action in terms of
the elements of the causes of action alleged by the plaintiff.
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
negligence or Defendant's allegedly wrongful denial of Plaintiff's
Healthcare Pharm., Inc., 3:13-CV-00656-JHM, 2013 WL 5656111 (W.D.
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.”).
for this curious coyness must be derived from the court’s final
disposition on the motion to dismiss. The court reserved ruling on
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
dangerous product Mirena . . . .”
Compl. at 1.
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.
levonorgestrel and PTC/IIH).
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.
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.
court finds that plaintiff has failed to state a claim for breach
defendant’s motion to dismiss.
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
Implied warranties are covered by the Alabama Commercial
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
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
Def.’s Mem. at 7.
The key to defendant’s argument is
the “e.g., preventing pregnancy” at the end of it.
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
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).
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.
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
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
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.”
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
Id. at 572 (emphases in original).
This reasoning would seem to answer the question decisively:
the commercial code creates only commercial warranties, not safety
However, the Spain court next described a subsequent
case, Allen v. Delchamps, Inc., 624 So. 2d 1065 (Ala. 1993), in
which the court reached an apparently opposite result.
So. 2d at 109.
In Allen, the plaintiff brought an implied warranty
claim, along with AMELD and other tort claims, after having a
defendant grocery store.
624 So. 2d at 1066-67.
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.’”
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
The implied warranty analysis “requires a fact-intensive
analysis” separate from any tort claims.
Id. at 108.
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
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
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.
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
The remainder of defendant’s criticisms are less successful.
Defendant first argues that plaintiff fails to state a claim for
negligent design (plaintiff’s Count I).
Def.’s Mem. at 5-6.
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).
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.
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.”
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
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
[PTC/IIH] with Mirena,” Compl. ¶ 90. With respect to the causation
and injury elements, plaintiff recites a medical history of the
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.
It is, of couse,
“reasonable.” Frankly, a jury is as qualified to determine what is
or is not “plausible.”
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).
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.”
Yamaha Motor Co., Ltd. v. Thornton, 579 So. 2d 619, 621 (Ala.
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
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
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.
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
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
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).
dangerous when used as it was intended to be used because it
increases the risk of developing PTD/IIH.
This allegation is all
that is required for the AEMLD claim to survive defendant’s motion
Breach of Express Warranty
Defendant next argues the plaintiff has failed to state a
claim for breach of express warranty (plaintiff’s Count V).
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,
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.”
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 . . .
Id. ¶ 71.
As to the breach element, she has alleged that
representations because Mirena is not safe or effective and may
[PTC/IIH] . . . .”
Id. ¶ 154.
Taken as true, these allegations
“plausibly,” in the eyes of this court, state a claim for breach of
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).
requires that, “[i]n alleging fraud or mistake, a party must state
In the Eleventh Circuit, this means that “a plaintiff
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).
Iqbal standard, this is not a hard-and-fast test, but can vary
based on the nature of the claim asserted.
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.
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.
In Alabama, a drug manufacturer “may be held
omission)” based on “information and warning deficiencies” on a
Wyeth, Inc. v. Weeks, No. 1101397, 2013 WL
135753, at *19 (Ala. Jan. 11, 2013).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
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.
carries with it the same FDA approval requirements as did the drug
Compl. ¶ 14.
Thus, like the Wyeth plaintiffs, plaintiff
defendant manufacturer’s breach of its “duty to warn . . . about
the risks associated with the long-term use of the drug” in its
Wyeth, 2013 WL 135753, at *2.
“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
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
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.
Defendant’s motion to dismiss will therefore be denied
as to plaintiff’s fraud-based claims.
Failure to Warn
Defendant does not argue that plaintiff’s final claim, the
failure to warn claim, (plaintiff’s Count II), is deficient.
motion to dismiss will therefore be denied as to this claim.
plaintiff concludes with the request that, “should this [c]ourt
respectfully requests leave to amend her complaint.” Pl.’s Mem. at
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.”
Gould, 554 F.3d 962, 967 (11th Cir. 2009) (quoting Posner v. Essex
especially true when, as here, the plaintiff does not bother to
submit or even describe its proposed amendment.
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.
For all the foregoing reasons, defendant’s motion to dismiss
will be granted as to plaintiff’s breach of implied and express
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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