Reed et al v. Pfizer, Inc. et al
Filing
32
MEMORANDUM AND ORDER: All claims against defendants are dismissed without prejudice and with leave to amend. The second amended complaint shall be filed within 30 days of the date this order is entered on the docket. Ordered by Judge Eric N. Vitaliano on 3/14/2012. (Brucella, Michelle)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
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BRENDA REED AND RONALD REED,
MEMORANDUM & ORDER
Plaintiffs,
10-CV-05356 (ENV) (RER)
-againstPFIZER, INC. AND WYETH LLC,
Defendants.
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VITALIANO, D.J.
Plaintiffs Brenda and Ronald Reed, citizens of West Virginia, commenced this action on
November 19,2010 seeking damages resulting from Ms. Reed's ingestion of Lybrel, an oral
contraceptive pill allegedly designed, developed, and sold by defendants Pfizer, Inc. ("Pfizer")
and Wyeth LLC ("Wyeth"). On January 20,2011, defendants filed a letter requesting a premotion conference and permission to file a motion to dismiss. In that letter, defendants argued
that plaintiffs' complaint should be dismissed based on a failure to plead plausible claims. The
Court held the requested pre-motion conference on February 8, 2011. At that conference,
"plaintiffs acknowledged that the complaint allowed room for further factual details."
(Plaintiffs' Opposition, at 1.) The Court provided plaintiffs 30 days to file an amended
complaint, which plaintiffs did do on the thirtieth day.
Defendants now move to dismiss the amended complaint for failure to state a claim upon
which relief can be granted, arguing that, like the original complaint, the amended complaint
fails to state plausible claims. Plaintiffs oppose defendants' motion, but as an alternative, seek
leave to amend their pleadings yet again.
For the reasons recounted below, the motion to dismiss is granted without prejudice, and
1
with leave to amend.
I.
BACKGROUND!
In early 2009, Ms. Reed was prescribed Lybrel to alleviate heavy menstrual periods.
(Plaintiffs' Amended Complaint ("Compl.") at ~15.) Shortly thereafter, she began ingesting
Lybrel, one dose per day. (ld. at ~ 16.) The complaint concludes that, "[a]s a direct and
proximate result of ingesting Lybrel, [Ms. Reed] developed deep vein thrombosis ("DVT"),
pulmonary embolus, vein and tissue damage, severe pain in the left leg and right lung, difficulty
breathing, and other serious injuries that required hospitalization, extensive testing, and other
medical treatment." (ld. at ~ 19.) Ms. Reed, it is further alleged, "has been incapacitated from
her normal functioning" and "will require lifelong medical care and attention." (ld. at ~ 20.)
Furthermore, plaintiffs allege, inter alia, (1) defendants knew or should have known that
Lybrel was "negligently created, formulated, designed, manufactured, tested, and marketed, that
the drug was not accompanied by adequate warnings; that medical professionals were
prescribing the drug for non-approved uses; and that the drug was otherwise negligently and
recklessly advertised, marketed, promoted, distributed, and sold," and (2) defendants
"improperly obtained the approval of the FDA to market Lybrel by misrepresenting the risks of
the drug to the FDA and/or by failing to inform the FDA of risks inherent in the use of the drug,"
and that such misrepresentations "deprived [Ms. Reed] of the opportunity to make an informed
choice regarding the risks and benefits associated with" Lybrel. (Compl. at ~~ 10, 14,23.)
II.
STANDARD OF REVIEW
Federal Rule of Civil Procedure 8(a)(2) requires "a short and plain statement of the claim
showing that the pleader is entitled to relief." This rule does not compel a litigant to supply
! The background facts are drawn from plaintiffs' pleadings and are considered true for purposes
of this motion.
2
"detailed factual allegations" in support of his claims, Bell Atlantic Corp. v. Twombly, 550 U.S.
544, 555, 127 S. Ct. 1955, 1964 (2007), "but it demands more than an unadorned, the-defendantunlawfully-harmed-me accusation." Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949 (2009). "A
pleading that offers 'labels and conclusions' ... will not do." Id. (quoting Twombly, 550 U.S. at
555); see also In re NYSE Specialists Sec. Litig., 503 F.3d 89, 95 (2d Cir. 2007). "Nor does a
complaint suffice if it tenders 'naked assertions' devoid of 'further factual enhancement. '" Iqbal,
129 S. Ct. at 1949 (quoting Twombly, 550 U.S. at 557).
Moreover, under Rule 12(b)(6), a complaint must be dismissed if it does not "contain
sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'"
Id. (quoting Twombly, 550 U.S. at 570). "A claim has facial plausibility when the plaintiff
pleads factual content that allows the court to draw the reasonable inference that the defendant is
liable for the misconduct alleged." Id. Determining plausibility is "a context-specific task that
requires the reviewing court to draw on its judicial experience and common sense." Id. at 1950.
That said, the factual allegations are paramount as "a complaint need not pin plaintiff s
claim for relief to a precise legal theory" nor provide "an exposition of his legal argument."
Skinner v. Switzer, 131 S. Ct. 1289, 1296 (2011). In analyzing well-pled facts, a court will draw
all reasonable inferences in favor of plaintiff. See Gorman v. Consol. Edison Corp., 488 F.3d
586,591-92 (2d Cir. 2007). Of course, though a court must presume the truth of all factual
allegations in the complaint for purposes of Rule 12(b)(6), the court is not bound to accept the
truth oflegal conclusions couched as factual allegations. Papasan v. Allain, 478 U.S. 265, 286,
106 S. Ct. 2932, 2944 (1986). Further, on a motion to dismiss, a court may only consider the
pleading itself, documents that are referenced in the complaint, documents that the plaintiff
relied on in bringing suit and that are either in the plaintiff s possession or that the plaintiff knew
of when bringing suit, and matters of which judicial notice may be taken. See Chambers v. Time
3
Warner, Inc., 282 F.3d 147, 153 (2d Cir. 2002); Int'l Audiotext Network, Inc. v. Am. Tel.& Tel.
Co., 62 F.3d 69, 72 (2d Cir. 1995).
Finally, should a court find pleadings to be inadequate, Rule 15(a) provides that the
district court should freely grant leave to amend those pleadings when justice so requires. But, a
district court correctly denies leave to amend "when an amendment is offered in bad faith, would
cause undue delay or prejUdice, or would be futile." Leonelli v. Pennwalt Corp., 887 F.2d 1195,
1198 (2d Cir. 1989) (citing Foman v. Davis, 371 U.S. 178, 182,83 S.Ct. 227, 230 (1962)).
III.
DISCUSSION
The theories of liability initially relevant to determining whether plaintiffs have stated a
viable claim are (1) failure to warn, (2) manufacturing defect, (3) design defect, (4) breach of
express warranty, and (5) breach of implied warranty.2 Lewis v. Abbott Labs., No. 08 Civ. 7480,
2009 WL 2231701, at *4-6 (S.D.N.Y. July 24,2009) (cataloging various product liability
theories and their redundancies); accord Morningstar v. Black and Decker Mfg. Co., 253 S.E.2d
666,678,681-83 (W.Va. 1979); Michael v. Wyeth, LLC, Civil Action No. 2:04-0435, 2011 WL
2150112, at *1-10 (S.D.W.Va May 25,2011).
A.
Failure to Warn
To prevail on a failure to warn claim, a plaintiff must prove, "(1) a manufacturer has a
duty to warn (2) against dangers resulting from foreseeable uses about which it knew or should
have known, and (3) that failure to do so was the proximate cause of the harm." State Farm Fire
2 Plaintiffs label their causes of action as "Negligence," "Strict Products Liability," "Negligence
- Failure to Warn," "Breach of Express Warranty," "Breach ofImplied Warranty," and "Loss of
Consortium." Neither party addresses whether New York law or West Virginia law governs
here. But defendants' citations to New York and West Virginia law for each potential cause of
action implicitly represent the relevant law of the two states are equivalent for purposes of this
motion. Further, plaintiffs either concede the same or represent that New York law governs, by
relying exclusively on New York law when discussing the elements of the potential claims in
their opposition.
4
& Cas. Co. v. Nutone, Inc., 426 F. App'x 8, 10 (2d Cir. 2011) (citing Liriano v. Hobart Corp., 92
N.Y.2d 232,237, 700 N.E.2d 303 (1998»; accord Morningstar, 253 S.E.2d at 682-83. As part of
satisfying those elements, a plaintiff is "required to prove that the product did not contain
adequate warnings." Mulhall v. Hannafin, 45 A.D.3d 55,841 N.Y.S.2d 282 (1st Deptt 2007).
Following logically, a failure to warn cause of action is appropriately dismissed if a plaintiff does
not plead facts indicating how the provided warnings were inadequate. Bailey v. Janssen
Pharmaceutic a, Inc., 288 F. App'x 597, 608-09 (l1th Cir. 2010) (affirming the dismissal ofa
failure to warn claim when the complaint "only assert[ed] that the warning was insufficient
because it failed to warn of various dangers of the use of [the drug], without explaining either the
information available to [the] physician at the time of the administration of the drug or how the
contents of the label were inadequate"); Wendell v. Johnson & Johnson, No. C 09-04124, 2010
WL 271423, at *4 (N.D. Cal Jan. 202010) (dismissing a failure to warn claim because the
plaintiffs "fail[ed] to allege how [the] warnings about [the drug] were inadequate"); Mills v.
Bristol-Myers Squibb Co., No. CV 11-968,2011 WL 3566131, at *3 (D. Ariz. Aug. 12,2011)
(dismissing a failure to warn claim because (1) plaintiff did not "plead any facts about what the
[drug] label said or how it was deficient;" and (2) "the warning did describe a risk of [the alleged
injury ]").
Plaintiffs describe Ms. Reed's injuries as "deep vein thrombosis ("DVT"), pUlmonary
embolus, vein and tissue damage, severe pain in the left leg and right lung, difficulty breathing,
and other serious injuries that required hospitalization, extensive testing, and other medical
treatment." (CompI. at ~~ 19.) In contrast with their thorough recitation of Ms. Reed's claimed
injuries, plaintiffs plead nothing about the content of Lybrel's warnings. This is likely because,
as defendants note by reference to the FDA's website, Lybrel's FDA-approved warning labels
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warn of the very injuries plaintiffs have pled. 3 Plaintiffs have not contested the authenticity of
these FDA warnings despite having had an opportunity to do so. In that regard, the Court takes
judicial notice that the warnings advanced by defendants are the FDA-approved warnings for
LybreI. 4 See Kramer v. Time Warner Inc., 937 F.2d 767,774 (2d Cir. 1991) (holding district
courts may take judicial notice of the contents of certain public records); Muller-Paisner v.
TIAA, 289 F. App'x 461, 466, n. 5 (2d Cir. 2008) (holding that judicial notice "may be taken of
the defendants' website for the fact of its publication"); Anspach ex reI. Anspach v. City of
Philadelphia, Dept. of Public Health, 503 F.3d 256,273 n. 11 (3d Cir. 2007) (taking judicial
notice of an FDA publication, "not for the truth of its contents, but rather as evidence of the
information provided by the federal government to healthcare providers").
Given all of this, the Reeds fall short of stating a failure to warn claim because the
amended complaint does not allege facts identifying how the provided warnings were
inadequate. Instead it first alleges (1) "the drug was not accompanied by adequate warnings;"
and (2) the drug was promoted "without sufficient disclosure of its dangerous propensities."
(CompI.,-r,-r 10, 14.) But assertions that warnings were not "adequate" or "sufficient" are nothing
more than legal conclusions unsupported by factual content. The fact gap is never closed. The
(E.g., Vicari Dec., Ex. B at 10 ("An increased risk of venous thromboembolic and thrombotic
disease associated with the use of oral contraceptives is well established"); at 25 ("the following
medical conditions have been associated with or made worse by the pill ... Blood clots in the
legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in
the brain (stroke), blockage of blood vessels in the heart (heart attack and angina pectoris) or
other organs of the body"); at 35 ("Blood clots and blockage of blood vessels are the most
serious side effects of taking oral contraceptives and can cause death or serious disability. In
particular, a clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can
cause a sudden blocking of the vessel carrying blood to the lungs"); at 38 ("[i]f any of [the
following] adverse effects occur while you are taking oral contraceptives, call your health care
professional immediately: ... sudden shortness of breath (indicating a possible clot in the lung)
... Pain in the calf (indicating a possible clot in the leg) .... ")
3
To be clear, the Court does not take judicial notice of the truth, accuracy, or sufficiency of these
warnings.
4
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complaint runs on merely to allege (1) defendants "misrepresent[ed] the risks of the drug to the
FDA and/or fail[ed] to inform the FDA of risks inherent in the use of the drug;" and (2) the
"warnings and information given to the medical community and women consumers did not
accurately reflect the symptoms, duration, scope, or severity of the potential side effects, health
concerns, and risks associated with ingesting LybreI." (Compi. ~~ 14, 40.) These additional
allegations are simply not "enough to raise a right to relief above the speculative level" since
they do not include "enough factual matter (taken as true) to suggest that a [misrepresentation]
was made." Twombly, 127 S.Ct at 1965. Pointedly, these allegations do not include any factual
content regarding what the misrepresentations were or how the provided warnings and
information failed to "accurately reflect" reality; they do not provide a plausible basis to support
an inference that Pfizer and Wyeth misrepresented anything. 5 Iqbal, 129 S.Ct. at 1949.
To cut to the chase, the fact (taken here as true) that Ms. Reed suffered from certain
conditions that were also identified risks of ingesting Lybrel is tragic, but cannot alone make
plausible a claim that defendants misrepresented or hid those risks in some way. Plaintiffs have
alleged factual content sufficient only to make plausible that Ms. Reed ingested Lybrel and
thereafter suffered serious harm. If such allegations were sufficient to state a failure to warn
The Court agrees with plaintiffs' argument that Twombly did not impose a pleading standard
beyond that required by Rule 8, and that plaintiffs are thus required only to provide "a short and
plain statement of the claim showing that the pleader is entitled to relief." FRCP 8(a). see Arista
Records, LLC v. Doe 3, 604 F.3d 110, 119 (2d Cir. 2010) ("[T]he notion that Twombly imposed
a heightened standard that requires a complaint to include specific evidence, factual allegations
in addition to those required by Rule 8, and declarations from the persons who collected the
evidence is belied by the Twombly opinion itself."). But, at the same time, and apparently
overlooked by plaintiffs, Twombly quite clearly interpreted the language of Rule 8 as requiring
allegations to be plausible. Twombly, 550 U.S. at 557 ("The need at the pleading stage for
allegations plausibly suggesting (not merely consistent with) [wrongdoing] reflects the threshold
requirement of Rule 8(a)(2) that the 'plain statement' possess enough heft to 'sho[w] that the
pleader is entitled to relief. "'); Arista Records, 604 F .3d at 120 ("The Twombly plausibility
standard ... applies to all civil actions.") (citing Iqbal, 129 S.Ct. at 1953).
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claim, then anyone experiencing harm after using a product where the harm is a warned-of risk
could successfully plead a claim. Perversely, the pleaded fact that a warning was given would be
the only pleaded fact supporting the claim that a lawfully adequate warning was not given. See
Salvio v. Amgen Inc., No. 2:11-cv-00553, 2012 WL 517446, *6 (W.D.Pa Feb. 15,2012)
(dismissing a failure to warn claim because the "warning provided by Defendants advised
Decedent's prescribing physicians of the very injury that occurred.") To allow such a naked
claim to go forward would merely green light for plaintiffs an expedition designed to fish for an
"in terrorem increment of the settlement value, rather than a reasonably founded hope that the
discovery process will reveal relevant evidence." Dura Pharmaceuticals, Inc. v. Broudo, 544
U.S. 336, 347, 125 S.Ct. 1627 (2005) (quoting Blue Chip Stamps v. Manor Drug Stores, 421
U.S. 723, 741, 95 S.Ct. 1917 (1975)).
Accordingly, the Court finds that plaintiffs have not plausibly pled a failure to warn claim
in their amended complaint. Indeed, the facts before the Court are that defendants did warn of
the relevant risks. Plausibility requires some factual assertions as to how or why the
acknowledged warning was inadequate, that is, about what risk of harm, or in what way, the
acknowledged warning failed to warn.
B.
Manufacturing Defect
A manufacturing defect claim is premised on the relevant product being defective
because it was not manufactured as designed. See Am. Guarantee & Liab. Ins. Co. v. Cirrus
Design Corp., No. 09 Cv. 8357,2010 WL 5480775, at *3 (S.D.N.Y. Dec. 30,2010);
Morningstar, 253 S.E.2d at 681. Consistent with that premise, a manufacturing defect claim is
properly dismissed if a plaintiff has not alleged "that the particular [drug] administered to her
had a defect as compared to" other samples of that drug. Lewis, 2009 WL 2231701, at *2.
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Plaintiffs fail to plead any facts making such an allegation. Rather, they merely plead the
legal conclusions that defendants were (1) "negligent" in "formulating" "fabricating,"
"manufacturing," and "packaging," Lybrel; (2) did so "in violation of applicable statutes,
regulations, and appropriate standards of care;" and (3) "failed to perform sufficient and
necessary testing that would have shown Lybrel's defective condition." (Compl. at ~~ 23,29,
30.) By not pleading facts indicating how or why the Lybrel ingested by Ms. Reed differed from
its design, plaintiffs have not enabled the Court "to draw the reasonable inference that the
defendant[s are] liable for the misconduct alleged." 19 bal, 129 S. Ct. at 1949 (quoting Twombly,
127 S. Ct. 1955). The manufacturing defect claim does not survive pleading.
C.
Design Defect
A design defect claim, on the other hand, is premised on a manufacturer's failure to
properly design a product, which is then placed on the market despite posing inappropriate risks.
Voss v. Black & Decker Mfg., 59 N.Y.2d 102,107 (N.Y. 1983). Morningstar, 253 S.E.2d at
681. Again, eschewing the opportunity to plead facts identifying Lybrel's design defect, the
Reeds merely plead the legal conclusion that the Lybrel was defective. (Compl. at ~~ 10, 13)
("Defendants knew ... the drug was negligently ... designed," and that "the benefits of using
Lybrel, if any, did not outweigh the risks inherent in the use of the drug.") Such pleadings are
subject to dismissal. Lewis, 2009 WL 2231701, at *4 (dismissing a claim alleging that a drug
was "inherently dangerous" and had "side effects outweigh[ing] its benefits," without also
pleading factual content in support of those allegations).
Plaintiffs' design defect claim also fails for an additional reason. Plaintiffs do not plead
facts alleging the existence of a feasible alternative design that would make the product safer, as
is required to establish a design defect, under either New York or West Virginia law. Voss, 59
N.Y.2d at 108. Church v. Wesson, 385 S.E.2d 393,396 (W. Va. 1989). As a result of such a
9
failure, the claim is subject to dismissal. Lewis, 2009 WL 2231701, at *4 (finding a plaintiff did
not "meet her burden to allege evidence that [a drug] is not reasonably safe" because "plaintiff
has not alleged that it was feasible for [the manufacturer] to design [the drug] in a safer
manner"); Am. Gaurantee & Liab. Ins. Co., No. 09 Cv. 8357,2010 WL 5480775, at *3
(S.D.N. Y. Dec. 30 2010) (dismissing a design defect claim because plaintiff did not plead, inter
alia, "a feasible alternative design"). The complaint, as a consequence, does not validly plead a
design defect claim. 6
D.
Breach of Express and Implied Warranties
Any "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 creates an express warranty that the goods
shall conform to the affirmation or promise." N.Y.U.C.C. §2-313(I)(a); W. Va. Code, § 46-2313(I)(a). A successful claim of a breach of express warranty requires proof that an express
warranty existed, was breached, and that plaintiff had relied on that warranty. Horowitz v.
Stryker Corp., 613 F. Supp. 2d 271,285-86 (E.D.N.Y 2009); Horan v. Turnpike Ford, Inc., 433
S.E.2d 559 (W. Va. 1993). Further, a successful breach of warranty claim requires that the
product be defective. Plemmons v. Steelcase Inc., No. 04 Civ. 4023, 2007 WL 950137, at *5
To the extent a negligence claim could exist independently from, or as part of, any claims
discussed above, it fails because plaintiffs have not pled factual content sufficient to create a
plausible inference that defendants breached any duty they owed to Ms. Reed. Specifically, the
Reeds have not pled facts making it plausible (1) that anything that defendants did or failed to do
fell below the standard of reasonable care or (2) that the Lybrel was defective in any way
including in its warnings, manufacture, or design. See Am. Gaurantee & Liab. Ins. Co., 2010
WL 5480775, at *4 (explaining that "to recover in negligence under New York law, a successful
plaintiff must demonstrate the existence ofa duty, the breach of which may be considered the
proximate cause of the damages suffered by the injured party" and finding a complaint did not
adequately plead negligence because it did "not contain sufficient facts to establish either
knowledge of a defect on the part of [the defendant] or anything that [defendant] did that fell
below the standard of reasonable care that rendered the [product] defective"); Parsley v. General
Motors Acceptance Corp., 280 S.E.2d 703 (W.Va 1981) (explaining that "to establish a prima
facie case of negligence in West Virginia, it must be shown that the defendant has been guilty of
some act or omission in violation of a duty owed to the plaintiff').
6
10
(S.D.N.Y, March 29,2007) (citing Tardella v. RJR Nabisco, Inc., 178 A.D.2d 737, 737 (N.Y.
App. Div.3d Dep't 1991».
Plaintiffs fail to state an express warranty claim for reasons similar to why they did not
meet the standard for a failure to warn claim, a design defect claim, and a manufacturing defect
claim. The allegations are not sufficient to draw a reasonable inference that (1) Lybrel was
defective or (2) what defendants promised was different than what they provided. 7 Plaintiffs'
unsupported conclusions that Lybrel differed in some defective manner from what was warranted
lack the required factual content identifying that difference and making its existence plausible.
Horowitz v. Stryker Corp., 613 F. Supp. 2d 271,285 (E.D.N.Y 2009) is instructive here.
The Horowitz court dismissed an express warranty claim (relating to a failure of an artificial hip)
because, inter alia, the plaintiff did "not even describe how [the allegedly breached]
representation was made." 613 F. Supp. 2d at 286. In holding so, the court distinguished Huber
v. Howmedica Osteonics Corp., No. 07-2400,2008 WL 5451072 (D.N.J. Dec. 31, 2008), a case
in which a plaintiff was found to have properly stated a breach of express warranty claim
regarding the same type of artificial hip at issue in Horowitz. The Huber plaintiff alleged "the
existence of evidence showing that the .5% defect rate printed on the [artificial hip's] label is
actually much higher and that the defect rate was a basis of the bargain." Horowitz, 613 F. Supp.
2d 286, n. 8 (discussing Huber). As in Horowitz, and unlike in Huber, the Reeds have not
7 In addition to allegations discussed above, the amended complaint includes supplemental
allegations relevant to the warranty claims: (1) defendants "warranted that Lybrel had been
adequately tested for its intended use, that it was of merchantable quality, and that it was safe
and suitable for use by women as a daily oral contraceptive medication that would prevent
pregnancy and eliminate menstrual bleeding;" (2) the warranty was relied upon by the medical
community (presumably including Ms. Reed's doctor); (3) defendants knew or should have
known that the alleged warranty was false "in that Lybrel was not reasonably safe and fit for its
intended use, and was not of merchantable quality, [and] ... causes or contributes to serious
adverse health effects, risks, complications, and other injuries;" and (4) defendants "knew or
should have known that approximately half of the women who take Lybrel will not experience
cessation of menstrual bleeding." (Compi. at ~~ 47-50.)
11
alleged factual content sufficient for the Court to reasonably infer defendants breached any
representation of fact or promise. Plaintiffs have alleged nothing which makes plausible that
Lybrel's various risks differ from what was warranted.
8
For largely the same reasons, the Court finds plaintiffs have also failed to plead a proper
breach of implied warranty claim. Saratoga Spa & Bath v Beeche Sys. Corp., 230 A.D.2d 326,
330,656 N.Y.S.2d 787 (3d Dep't 1997) ("The implied warranty of merchantability is a guarantee
by the seller that its goods are fit for the intended purpose for which they are used and that they
will pass in the trade without objection ... [an implied warranty claim] cannot arise unless the
goods sold are not of merchantable quality. For goods to be of merchantable quality they need to
be reasonably fit for their intended purpose; they need not, however, be perfect."); N.Y.U.C.C.
§2-314; W. Va. Code, § 46-2-314. Viewed in this light, plaintiffs have not pled facts making it
plausible that Lybrel was not fit for its intended purpose.
Plaintiffs' factually consistent but conversely stated allegations that (1) "Defendants knew or
should have known that approximately half of the drug's users would experience cessation of
menstrual periods, Compi. at ~ 11, and (2) "Defendants knew or should have known that
approximately half of the women who take Lybrel will not experience cessation of menstrual
bleeding," Compi. at ~ 50, lack relevance because these broadly stated allegations are consistent
with Lybrel's FDA-approved warning labels. (Vicari Dec., Ex. B at 27) ("In a study of
LYBREL, about 5 out of 10 women had 7 or more days of bleeding or spotting while using their
third 28-day pill pack of LYBREL. The number of women with 7 or more days of bleeding or
spotting decreased to 3 out of 10 women during the use of their seventh pill pack. Among
women who continued to use L YBREL for one year, about 6 out of 10 women had no bleeding
or spotting during their last month of use ... MOST WOMEN HAVE SPOTTING OR
BLEEDING DURING THE FIRST FEW MONTHS OF TAKING LYBREL") (emphasis in
original). To the extent an inconsistency between Lybrel's warnings and defendants' actual
knowledge existed regarding the drug's effect on menstrual bleeding, the amended complaint
does not adequately identify it. Moreover, regarding reliance on any warranty (and causation in
her other claims), the amended complaint does not relate plaintiffs' allegations of Lybrel's ability
to cause "cessation of menstrual periods" to Ms. Reed's stated reason for taking Lybrel, i.e., "to
alleviate severely heavy menstrual periods." (Compi. at ~ 15.)
8
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E.
Leave to Further Amend is Granted9
Plaintiffs have already attempted, but failed, to overcome pleading inadequacies
previously identified. At the same time, what has been previewed in the amended complaint
suggests that, with guidance from this Memorandum and Order, that plaintiffs may yet be able to
plausibly re-plead at least some of their claims. The Court, as a result, grants leave to amend one
more time. In exercising its discretion to do so, the Court has considered the high value to be
placed on merit resolution of cases and controversies. Plaintiffs are advised that, given the
Court's specific identification of pleading shortcomings, failure to address them successfully in
the next round will not likely be rewarded with a third opportunity to cure.
IV.
CONCLUSION
For the foregoing reasons, all claims against defendants are dismissed without prejudice
and with leave to amend. The second amended complaint shall be filed within 30 days of the
date this order is entered on the docket.
SO ORDERED.
Dated: Brooklyn, New York
March 14,2012
s/ENV
•
C'
G
X
n
C
ERIC N. VITALIANO
United States District Judge
The loss of consortium claim is derivate, and therefore dismissed pro tanto. See Lake v.
Kardjian, 874 N.Y.S. 2d 751, 755 (Supp. Ct. 2008); Davis v. Foley, 457 S.E.2d 532, 535 (W. Va.
1995).
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