Becker v. Cephalon, Inc. et al

Filing 34

OPINION & ORDER re: 25 MOTION to Dismiss Plaintiffs' Amended Complaint. filed by Cephalon, Inc., Teva Pharmaceutical Industries Ltd. For the foregoing reasons, Defendants' motion to dismiss is granted. The Court respectfully directs the Clerk to terminate the motion at ECF No. 25 and to terminate the case in accordance with this Opinion. SO ORDERED. (Signed by Judge Nelson Stephen Roman on 9/15/2015) (mml)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
ISABEL L. BECKER, as Administratrix of the
Estate ofDeceased, NORWIN H. BECKER, and
ISABEL L. BECKER, individually,
14 Civ. 3864 (NSR)

Plaintiff,

OPINION & ORDER

-againstCEPHALON, INC., and TEVA
PHARMACEUTICAL INDUSTRIES, LTD.,
Defendants.
NELSON S. ROMAN, United States District Judge:

Plaintiff Isabel L. Becker ("Plaintiff' or "Becker") initiated the instant action as
administratrix of the Estate ofNorwin H. Becker ("Decedent") and on her own behalf, asserting
claims against Cephalon, Inc., and Teva Pharmaceutical Industries, Ltd. (collectively,
"Defendants") for failure to warn prospective patients of drug side effects, as well as other
related claims. Before the Court is Defendants' motion to dismiss the Complaint, pursuant to
Federal Rule of Civil Procedure 12(b)(6), for failure to state a claim upon which relief can be
granted. For the following reasons, Defendants' motion is GRANTED.

BACKGROUND
All facts are taken from the Amended Complaint and are accepted as true for the
purposes of this motion.

I.

Factual Background
This is a personal injury case arising from Decedent's use of the prescription drug

TREAl"\JDA, the administration of which allegedly "afflicted [D]ecedent with a toxic skin

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reaction resulting in horrendous and repeating exfoliative dermatitis such as or similar to
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (“SJS/TEN”).” (Am. Compl. ¶ 1.)
Norwin Becker, the decedent, was diagnosed with chronic lymphocytic leukemia in 2000.
(Am. Compl. ¶ 7.) He was a patient of Dr. Matthew Lonberg during all relevant time periods.
(Id. ¶ 7.) Dr. Lonberg administered allopurinol to Decedent on or about December 8, 2010, and
administered TREANDA to Decedent on multiple dates in December 2010 and January 2011.
(Id. ¶¶ 8-9.)
Plaintiff alleges that Cephalon “has known for many years that intravenous treatment
with TREANDA carried grave risks, including that of a patient suffering the skin burning and
continual peeling condition known as SJS/TEN and similar toxic skin reactions.” (Id. ¶ 10.) She
further alleges that Cephalon knew of additional grave risks associated specifically with the
administration of TREANDA in conjunction with, or shortly after, the administration of
allopurinol. (Id. ¶ 10.) The Food and Drug Administration (“FDA”) has warned Cephalon on
more than one occasion cited to by Plaintiff about misleading information contained in dosing
cards and sponsored links on internet search engines specifically regarding the risk of SJS/TEN.
(Id. ¶¶ 12-13.) Cephalon’s website for TREANDA has been modified several times, alternately
showing a warning that “[a] mild rash or itching may occur during treatment with TREANDA”
on some dates and displaying a warning about the more serious risk of SJS/TEN on others. (Id.
¶¶ 14-15, 20-24.)
Plaintiff alleges that Dr. Lonberg manifested ignorance of severe skin reactions as risks
of the administration of TREANDA and allopurinol, and that he “may have been misled by
having read the violative promotional materials for Treanda such as the dosing card, which was
the subject of the FDA’s letter of December 18, 2009, and further misled by the sanitized

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TREANDA.com homepage.” (Id. ¶ 16.) Had Dr. Lonberg been properly instructed of the risks of
severe skin reactions by Cephalon, “he would have advised decedent of the risks, and possibly
declined to prescribe TREANDA; in any event decedent would have declined treatment of
TREANDA.” (Id. ¶ 17.) Plaintiff also alleges that Decedent himself relied on these misleading
statements on the TREANDA webpage he visited in agreeing to treatment with TREANDA. (Id.
¶¶ 22-23.)
II.

Procedural History
Plaintiff commenced this action against Defendants in the Supreme Court of the State of

New York in the County of Rockland, on January 9, 2014. Pursuant to 28 U.S.C. § 1446,
Defendants removed the action to this Court on May 30, 2014. (See Not. Removal, ECF No. 1.)
Following a pre-motion conference, Defendants moved to dismiss the Complaint on February 27,
2015. (See Defs.’ Mot. Dismiss, ECF No. 25.)
STANDARD ON A MOTION TO DISMISS
To survive a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6) for
failure to state a claim upon which relief can be granted, a complaint must include “sufficient
factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft
v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 554, 570
(2007)). “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. (citing Twombly, 550 U.S. at 556).
“When there are well-pleaded factual allegations [in the complaint], a court should
assume their veracity and then determine whether they plausibly give rise to an entitlement to
relief.” Iqbal, 556 U.S. at 679. The court must thus “take all well-plead factual allegations as
true, and all reasonable inferences are drawn and viewed in a light most favorable to the
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plaintiff[ ].” Leeds v. Meltz, 85 F.3d 51, 53 (2d Cir. 1996). However, the presumption of truth
does not extend to “legal conclusions, and threadbare recitals of the elements of the cause of
action.” Harris v. Mills, 572 F.3d 66, 72 (2d Cir. 2009) (quoting Iqbal, 556 U.S. 662) (internal
quotation marks omitted). A plaintiff must provide “more than labels and conclusions” to show
he is entitled to relief. Twombly, 550 U.S. at 555.
The court should read pro se complaints “to raise the strongest arguments that they
suggest.” Kevilly v. New York, 410 F. App’x 371, 374 (2d Cir. 2010) (summary order) (quoting
Brownell v. Krom, 446 F.3d 305, 310 (2d Cir. 2006)). To survive a motion to dismiss, however,
even a pro se plaintiff must still assert “factual allegations sufficient to raise a ‘right to relief
above the speculative level.’” Jackson v. NYS Dep't of Labor, 709 F. Supp. 2d 218, 224
(S.D.N.Y. 2010) (quoting Twombly, 550 U.S. at 555).
DISCUSSION
I.

Consideration of Exhibits Submitted by the Parties on the Instant Motion
As an initial matter, the Court must decide whether it can consider and/or take judicial

notice of certain documents submitted by the parties. Defendants have submitted the following
documents with their motion, all annexed to the Declaration of Devorah Allon, Defendants’
counsel: the February 2010 TREANDA label in effect at the time TREANDA was administered
to the Decedent (Defense Ex. A 1); an April 22, 2009 FDA Approval letter to Cephalon (Defense
Ex. B); the December 21, 2010 TREANDA label (Defense Ex.C); and a December 18, 2009
FDA letter to Cephalon (Defense Ex. D). Plaintiff has submitted the following with her
opposition papers on the instant motion: reports prepared by Dr. Donald Waldorf (Plaintiff’s Ex.
1
Both parties labeled their exhibits using letters. To prevent confusion, all exhibits submitted by
Defendants are referred to as “Defense Ex. [Letter]” and all exhibits submitted by Plaintiff are referred to as
“Plaintiff’s Ex. [Letter].” The Defense Exhibits are appended to the Declaration of Defendants’ counsel, Devorah
W. Allon (see ECF No. 27); the Plaintiff’s Exhibits are attached to the Declaration of Jeffrey S. Becker (see ECF
No. 31).

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A); a report and pathologist’s report by Dr. Peter Burk (Plaintiff’s Ex. B); copies of the Cephalon
websites for TREANDA for patients and healthcare professionals, as captured on various dates
(Plaintiff’s Exs. C - I); and a March 26, 2009 FDA warning letter to Cephalon (Plaintiff’s Ex. J).
On a motion to dismiss, “the Court is entitled to consider facts alleged in the complaint
and documents attached to it or incorporated in it by reference, documents ‘integral’ to the
complaint and relied upon in it.” Heckman v. Town of Hempstead, 568 F. App’x 41, 43 (2d Cir.
2014); see Manley v. Utzinger, No. 10 Civ. 2210 (LTS)(HBP), 2011 WL 2947008, at *1 n.1
(S.D.N.Y. July 21, 2011) (“The Court may consider any written instrument attached to the
complaint, statements or documents incorporated into the complaint by reference, and documents
possessed by or known to the plaintiff and upon which the plaintiff relied in bringing the suit.”).
The Court may also consider “facts of which judicial notice may properly be taken under Rule
201 of the Federal Rules of Evidence.” Heckman, 568 F. App’x at 43.
Under Federal Rule of Evidence 201, “[t]he court may judicially notice a fact that is not
subject to reasonable dispute because it . . . can be accurately and readily determined from
sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201(b)(2). “If a court
takes judicial notice of documents pertinent to a motion to dismiss, it need not convert the
motion to dismiss into a motion for summary judgment.” Chapman v. Abbott Labs., 930 F. Supp.
2d 1321, 1323 (M.D. Fla. 2013); see Friedl v. City of New York, 210 F.3d 79, 83 (2d Cir. 2000);
Fonte v. Bd. of Managers of Cont’l Towers Condo., 848 F.2d 24, 25 (2d Cir. 1988). “In the
motion to dismiss context, a court should generally take judicial notice to determine what
statements the documents contain, not for the truth of the matters asserted.” Porrazzo v. Bumble
Bee Foods, LLC, 822 F. Supp. 2d 406, 412 (S.D.N.Y. 2011) (internal quotation marks and

5

alterations omitted). Thus, the Court does not attempt to discern the truth of any statements
contained in these exhibits, but rather simply takes judicial notice of the statements they contain.
Defense Exhibits A and C are FDA-approved labels for TREANDA, which are public
documents that may be judicially noticed because the labels “can be accurately and readily
determined from sources whose accuracy cannot reasonably be questioned.” Chapman, 930 F.
Supp. 2d at 1323 (quoting Fed. R. Evid. 201(b)(2)); see, e.g., Wright v. Medtronic, Inc., 81 F.
Supp. 3d 600, 606 (W.D. Mich. 2015); Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F.
Supp. 3d 619, 622-23 (W.D. Mich. 2015); In re Bayer Corp. Combination Aspirin Products
Mktg. & Sales Practices Litig., 701 F. Supp. 2d 356, 367-68 (E.D.N.Y. 2010) (taking judicial
notice of portions of FDA website); In re Epogen & Aranesp Off–Label Mktg. & Sales Practices
Litig., 590 F. Supp. 2d 1282, 1286 (C.D. Cal. 2008) (“The Court grants DaVita's request as to
Exhibits 1-4, labels for Epogen that are publicly available on the FDA website, finding that the
labels are documents not subject to reasonable dispute.”)
Defense Exhibits B and D (mistakenly referenced as Exhibit E in counsel’s declaration,
but labeled as Exhibit D) are letters to Caphalon from the FDA. Both of these letters are publicly
available on the FDA website and judicially noticeable for the same reasons as the drug labels
themselves are judicially noticeable. Defense Exhibit D is also specifically quoted in Plaintiff’s
Amended Complaint and therefore is a “document[] ‘integral’ to the complaint and relied upon
in it.” Heckman, 568 F. App’x at 43.
As to the documents submitted by Plaintiff, several of these are integral to the complaint
and clearly replied upon in it, which means they can be considered on the instant motion to
dismiss even though they were not attached to the Amended Complaint. For example, Plaintiff’s
Exhibit J is another letter to Cephalon from the FDA, quoted in the complaint. (See Am. Compl.

6

¶ 13.) Similarly, Plaintiff’s Exhibits C, D, E, and F are copies of the TREANDA website, as
depicted on various dates described in the Amended Complaint. The contents of the website on
these dates are quoted throughout Plaintiff’s allegations. (See Am. Compl. ¶¶ 20-23.) “[W]hen a
document is referred to in the pleadings and is integral to the claims, it may be considered
without converting a motion to dismiss into one for summary judgment.” Commercial Money
Ctr., Inc. v. Ill. Union Ins. Co., 508 F.3d 327, 335–36 (6th Cir.2007).
Some of the exhibits submitted have not been considered on the instant motion.
Plaintiff’s Exhibits A and B are medical records cited to support the allegations in the Amended
Complaint regarding Decedent’s injury. The records (and/or the doctors who created them) are
not discussed in the pleadings, and Plaintiff has not addressed whether these can be considered
on the instant motion. While Plaintiff alleges that Decedent was afflicted “with a toxic skin
reaction resulting in horrendous and repeating exfoliative dermatitis such as or similar to
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis,” there is no actual diagnosis for
Decedent’s health issues alleged in the Amended Complaint. (See Am. Compl. ¶ 1.) Plaintiff’s
Exhibits G, H, and I are copies of the TREANDA website, as accessed on various dates after
those described in Plaintiff’s Amended Complaint. These iterations of the website are not
discussed in the Complaint and were versions of the website that were posted after the events in
this case occurred, and therefore their contents could not have been considered by Decedent or
his physician when contemplating treatment options. Because these documents do not appear,
from the allegations in the pleadings, to be integral to the complaint and are not incorporated into
the complaint by reference or attached to it, the Court will not consider the extrinsic evidence
contained in these specific exhibits on the instant motion.

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II.

Strict Liability and Negligence Claims
Plaintiff’s first two causes of action are for strict liability and negligence based on

Cephalon’s alleged “failure, in its marketing and promotion of TREANDA, to warn, and for its
misrepresentation of risks of grievous side effects of TREANDA.” (Am. Compl. ¶ 29; see id. ¶
30 (replacing “failure” with “negligent failure,” and “misrepresentation” with “negligent
misrepresentation”).) A strict products liability claim arises where “(1) the product is defective,
and (2) the defect caused plaintiff’s injury.” Lewis v. Abbott Labs., No. 08 Civ. 7480 (SCR)
(GAY), 2009 WL 2231701, at *4 (S.D.N.Y. July 24, 2009) (citing Colon ex rel. Molina v. BIC
USA, Inc., 199 F. Supp. 2d 53, 82 (S.D.N.Y. 2001)). A negligence claim arises where “(1) the
manufacturer owed plaintiff a duty to exercise reasonable care; (2) the manufacturer breached
that duty by failing to use reasonable care so that the product was rendered defective; (3) the
defect was the proximate cause of the plaintiff’s injury; and (4) plaintiff suffered loss or
damage.” DiBartolo v. Abbott Labs., 914 F. Supp. 2d 601, 611 (S.D.N.Y. 2012) (internal
quotations omitted). “Under New York law, ‘[f]ailure to warn claims are identical under strict
liability and negligence theories of recovery.’” Id. (quoting Lewis, No. 08 Civ. 7480 (SCR)
(GAY), 2009 WL 2231701, at *5).
To maintain a claim for an injury that is the side effect of a properly manufactured
prescription drug, a plaintiff must show “that the drug caused her injury and that the
manufacturer breached a duty to warn of the possibility that the injurious reaction might occur.”
Lindsay v. Ortho Pharm. Corp., 637 F.2d 87, 90-91 (2d Cir. 1980). “The manufacturer's duty is
to warn of all potential dangers which it knew, or in the exercise of reasonable care should have
known, to exist.” Id. at 91. The manufacturer owes this duty to the doctor, not the patient,
because “[t]he doctor acts as an informed intermediary between the manufacturer and the patient,
evaluating the patient's needs, assessing the risks and benefits of available drugs, prescribing
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one, and supervising its use.” Id. (internal quotation marks omitted); see also Martin v. Hacker,
83 N.Y.2d 1, 9, 628 N.E.2d 1308, 1311, 607 N.Y.S.2d 598, 601 (N.Y.1993) (“Warnings for
prescription drugs are intended for the physician, whose duty it is to balance the risks against the
benefits of various drugs and treatments and to prescribe them and supervise their effects.”). The
informed intermediary doctrine (“IID”) precludes products liability claims for prescription drugs
based solely on a theory that the manufacturer failed to warn the patient, as opposed to the
prescribing doctor. See Figueroa v. Boston Scientific Corp., 254 F. Supp. 2d 361, 370 (S.D.N.Y.
2003) (“The manufacturer’s duty of adequate warning is therefore fulfilled by providing
sufficient information of the product’s risk to the treating physician, rather than to the patient
directly.”).
A prescription medicine warning can be found adequate as a matter of law, see Alston v.
Caraco Pharm., Inc., 670 F. Supp. 2d 279, 286-87 (S.D.N.Y. 2009) (“Courts have routinely held
as a matter of law that a drug manufacturer will not be liable if there is evidence showing that the
warning specifically warned of the side effects which occurred.”), and in New York such a
warning is adequate when it communicates a warning as to “the precise malady incurred,”
Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 60 (N.Y. App. Div. 1979); Fane v. Zimmer, 927 F.2d
124, 129 (2d Cir. 1991); Reed v. Pfizer, Inc., 839 F. Supp. 2d 571, 577 (E.D.N.Y. 2012)
(dismissing failure-to-warn claim with prejudice because label warned of relevant risks); Lewis
v. Abbott Labs., No. 08 Civ. 7480 (SCR) (GAY), 2009 WL 2231701, at *5 (S.D.N.Y. July 24,
2009). In this case, the FDA-approved label for TREANDA is unequivocal in warning about the
risk of SJS/TEN and similar serious skin reactions, including a warning about the administration
of TREANDA concomitantly with allopurinol. (See Defense Ex. A at 3, 4, 8, 13.)

9

While a court must generally accept a plaintiff’s factual allegations as true in evaluating a
motion to dismiss, it “need not accept as true allegations in a complaint that contradict or are
inconsistent with judicially-noticed facts.” Chapman, 930 F. Supp. 2d at 1323; see In re Bayer
Corp. Combination Aspirin Products Mktg. & Sales Practices Litig., 701 F. Supp. 2d 356, 36768 (E.D.N.Y. 2010) (“Although the purpose of a motion to dismiss is to test the legal sufficiency
of a plaintiff's claims, taking all the allegations as true and reading them in the light most
favorable to the plaintiff, the court is not required to reason in a vacuum.”). Plaintiff’s allegations
that Cephalon failed to warn of the risk of SJS/TEN when taking TREANDA, particularly in
conjunction with allopurinol, are squarely contradicted by the TREANDA label. Section 5.5 of
the TREANDA label in effect at the time TREANDA was administered to Decedent reads, in its
entirety:
5.5 Skin Reactions
A number of skin reactions have been reported in clinical trials and postmarketing safety reports. These events have included rash, toxic skin reactions
and bullous exanthema. Some events occurred when TREANDA was given in
combination with other anticancer agents, so the precise relationship to
TREANDA is uncertain.
In a study of TREANDA (90 mg/m2) in combination with rituximab, one
case of toxic epidermal necrolysis (TEN) occurred. TEN has been reported for
rituximab (see rituximab package insert). Cases of Stevens-Johnson syndrome
(SJS) and TEN, some fatal, have been reported when TREANDA was
administered concomitantly with allopurinol and other medications known to
cause these syndroms. The relationship to TREANDA cannot be determined.
Where skin reactions occur, they may be progressive and increase in
severity with further treatment. Therefore, patients with skin reactions should be
monitored closely. If skin reactions are severe or progressive, TREANDA should
be withheld or discontinued.
(Def. Ex. A at 3.) Section 6, “Adverse Reactions,” also includes a note that skin reactions are one
form of serious adverse reaction associated with TREANDA in clinical trials, and refers
physicians to Section 5.5 for further detail. (Defense Ex. A at 4.) Section 6.3 specifically warns
10

of the risks of SJS and TEN when TREANDA is administered concomitantly with allopurinol
and other medications. (Defense Ex. A at 8.) “Because all of the alleged side effects described by
[Plaintiff] are specifically indicated as potential side effects in [the drug’s] package insert, the
warning is adequate as a matter of law.” Alston, 670 F. Supp. 2d at 287. Thus, Plaintiff’s strict
liability and negligence products liability claims based on a failure to warn theory are foreclosed
and must be dismissed.
Plaintiff attempts to circumvent the IID by alleging that her products liability claims are
based not only on a failure-to-warn theory, but also on Cephalon’s affirmatively misleading
statements to both the Decedent and his doctor regarding the risk of a mild rash versus more
serious skin conditions like SJS/TEN. (See Pl.’s Opp’n at 17-18.) The statements in question
include Section 17 of the TREANDA label, which states:
17 PATIENT COUNSELING INFORMATION
***
Rash
Advise patients that a mild rash or itching may occur during treatment with
TREANDA. Advise patients to immediately report severe or worsening rash or
itching.
(Defense Ex. A at 13). Plaintiff avers that Section 17 “renders the warning ineffective.” (Pl.’s
Opp’n at 9). This is illogical and contradicted by the label, however, as not only do several
sections of the TREANDA label explicitly warn of the risk of SJS/TEN and other severe skin
reactions, but Section 17 itself tells doctors to advise their patients that they should report
“severe or worsening rash or itching.” (See Defense Ex. A at 3, 4, 8, 13.) Further, the statement
regarding a risk of mild rash is not false. (See Defense Ex. A at 5, 7 (reporting “rash” as adverse
reaction in clinical studies). Therefore, it must be that the statement is misleading, if at all,
because it fails to emphasize the more serious risks—making Plaintiff’s claim, in essence, simply
a failure-to-warn claim, not a distinct type of claim or theory as Plaintiff asserts. As discussed
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above, any products liability claim based on a failure-to-warn theory cannot survive in this case
because the TREANDA label warns of the very malady allegedly suffered by Decedent. Further,
Plaintiff’s policy-based arguments are unsupported by citations to any cases actually finding that
the IID should not apply where there are allegations of misleading statements to consumers, not
just a failure to warn.
As unfortunate as the circumstances of Decedent’s illness are, a products liability claim
simply cannot lie against Cephalon based on the facts of this case because the TREANDA label
clearly and adequately warns of the very side effects suffered by the Decedent.
III.

Breach of Warranty Claim(s)
Plaintiff alleges that “Decedent relied . . . on the reputation and representations of

Cephalon in its promotion of TREANDA, which misled decedent to conclude that the potential
side effects of TREANDA were less severe than they truly were, and did not include the risk of
severe exfoliative skin reactions,” and that “Decedent had the right to expect that Cephalon
would stand behind its product and bear the burden for any injuries that [D]ecedent sustained as
a result of his use of TREANDA in reliance on Cephalon’s representations.” (Am. Compl. ¶ 31.)
Plaintiff does not specify in the Amended Complaint whether she asserts a claim for breach of
express warranty or breach of the implied warranty of merchantability, so both causes of action
are addressed here.
A.

Breach of Express Warranty

To state a claim for breach of express warranty, a plaintiff must allege that “there was an
affirmation of fact or promise by the seller, the natural tendency of which was to induce to buyer
to purchase and that the warranty was relied upon to the plaintiff’s detriment.” DiBartolo v.
Abbott Labs., 914 F. Supp. 2d 601, 625 (S.D.N.Y. 2012). “To plead a cause of action for breach
of express warranty, Plaintiff must allege: (1) the exact terms of the warranty; (2) that the
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warranty formed part of the basis of the bargain; (3) the warranty was breached and (4) the
breach caused injury to the plaintiff.” In re Hydroxycut Mktg. & Sales Practices Litig., No.
09MD2087-BTM (AJB), 2010 WL 2839480, at *2-3 (S.D. Cal. July 20, 2010) (applying New
York law) (citing Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 286 (E.D.N.Y. 2009); Fagan
v. AmerisourceBergen Corp., 356 F. Supp. 2d 198, 217 (E.D.N.Y. 2004)).
A breach of express warranty claim “require[s] a plaintiff to plead some affirmative
statement of fact that forms the basis of the warranty. The statement must be definite enough so
that its ‘natural tendency [is] . . . to induce the buyer to purchase.’” Elkind v. Revlon Consumer
Products Corp., No. 14-CV-2484 (JS)(AKT), 2015 WL 2344134, at *13 (E.D.N.Y. May 14,
2015) (quoting Weiner v. Snapple Beverage Corp., No. 07 Civ. 8742 (DLC), 2011 WL 196930,
at *5 (S.D.N.Y. Jan. 21, 2011)). Plaintiff alleges that the affirmative statement of fact that forms
the basis of the warranty is the “mild rash or itching” warning contained in Section 17 of the
TREANDA label and also found on Cephalon’s website for TREANDA and other marketing
materials. (Pl.’s Opp’n at 17.) As discussed in Section I, supra, this statement is not false. (See
Defense Ex. A at 5, 7). Therefore, if the statement is misleading at all, it is only because it fails
to emphasize more serious side effects, not because it makes an affirmative statement that is
itself problematic. Thus, Plaintiff’s claim, even if couched in the language of a breach of express
warranty, is fundamentally a failure-to-warn claim, and is defeated by the adequacy of
Cephalon’s TREANDA label. See McDowell v. Eli Lilly & Co., 58 F. Supp. 3d 391, 410
(S.D.N.Y. 2014) (“Relating a warning theory in terms of ‘warranty’ or ‘fraud’ does not avoid the
implications of an adequate warning.”).
B.

Breach of Implied Warranty

To state a claim for breach of the implied warranty of merchantability, a plaintiff must
allege that “a defect in the product was a substantial factor in causing the injury and . . . the
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defect complained of existed at the time the product left the manufacturer or entity in the line of
distribution being sued.” DiBartolo, 914 F. Supp. 2d at 627. The alleged defect may arise from
“a manufacturing flaw, improper design, or a failure to provide adequate warnings regarding use
of the product.” Adesina v. Aladan Corp., 438 F. Supp. 2d 329, 345 (S.D.N.Y. 2006).
Similarly to the claim for breach of express warranty, Plaintiff’s claim for breach of
implied warranty fails. Plaintiff has not alleged a manufacturing flaw or improper design, and
thus only a failure to provide adequate warnings regarding use of the product remains as a
potential ground for a breach of implied warranty claim. But as noted in earlier sections, the IID
bars such a claim where, as here, the prescription drug’s label is adequate as a matter of law
because it clearly and adequately warns the prescribing physician of the very malady suffered by
Decedent. See McDowell, 58 F. Supp. 3d at 410.
IV.

False Advertising Claim
New York General Business Law § 350 states: “[f]alse advertising in the conduct of any

business, trade or commerce or in the furnishing of any service in this state is hereby declared
unlawful.” N.Y. Gen. Bus. Law § 350. To state a claim for a § 350 violation, a plaintiff must
allege “(1) that the act, practice or advertisement was consumer-oriented; (2) that the act,
practice or advertisement was misleading in a material respect, and (3) that the plaintiff was
injured as a result of the deceptive practice, act or advertisement.” Pelman v. McDonald's Corp.,
237 F. Supp. 2d 512, 525 (S.D.N.Y. 2003). To determine whether the advertisement is false
within the statute’s meaning, “the test is whether the advertisement is likely to mislead a
reasonable consumer acting reasonably under the circumstances.” Andre Strishak & Assocs.,
P.C. v. Hewlett Packard Co., 300 A.D.2d 608, 609 (N.Y. App. Div. 2002). In addition, a plaintiff
must also “plead reliance on the misleading advertising at the time of purchase.” Elkind, No. 14CV-2484 (JS)(AKT), 2015 WL 2344134, at *11; see Horowitz, 613 F. Supp. 2d 271, 288
14

(E.D.N.Y. 2009) (“In order to make a claim under NYGBL Section 350, a plaintiff must plead
reliance on a false advertisement at the time the product was purchased.”).
Plaintiff alleges that Cephalon falsely advertised that the side effects of TREANDA
would be limited to those of which it was aware and which it disclosed in its marketing and
presentation to physicians and patients. Plaintiff also alleges reliance on the reputation and
representations of Cephalon, and that its representations regarding the side effects of TREANDA
misled Decedent. Plaintiff’s claim, however, still bumps up against the IID. While Plaintiff
asserts that her claim is based on affirmatively misleading statements, it is clear from the
underlying allegations and the contents of the label that her claim is merely based on a failure-towarn theory. Though the New York state courts do not appear to have confronted the issue
directly, other courts, in applying New York law or similar laws of other states, have found that
the IID bars claims arising under consumer protection laws that are based on a failure-to-warn
theory where the label has been found adequate. See, e.g., Colacicco v. Apotex, Inc., 432 F.
Supp. 2d 514, 552 (E.D. Pa. 2006) aff'd, 521 F.3d 253 (3d Cir. 2008) cert. granted, judgment
vacated on other grounds, 556 U.S. 1101 (2009) (applying New York law and holding IID
precludes consumer protection claim “because the consumer protection statute forbids deceptive
acts or practices likely to mislead a reasonable consumer, specifically requiring proof that the
defendant's acts are directed at consumers, . . . while the [I]ID dictates that all pharmaceutical
information is directed at physicians, not consumer-patients. . . . Further, . . . prescription drugs
are not available in the same manner as usual consumer products.” (emphasis in original));
Heindel v. Pfizer, Inc., 381 F. Supp. 2d 364, 384 (D.N.J. 2004) (applying PA law, concluding
that IID bars consumer protection claim).

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V.

Misrepresentation Claim
Plaintiff also sets forth a claim for misrepresentation, alleging that “Cephalon, by its

communications directed to physicians such as Dr. Lonberg, falsely represented that the side
effects of TREANDA would be limited to those of which Cephalon was aware and which it
disclosed in its marketing and presentation to physicians and patients,” and that Cephalon’s
representations “may have misled Dr. Lonberg to conclude that the potential side effects of
TREANDA were less severe than they truly were, and did not include the risk of severe
exfoliative skin reactions.” (Am. Compl. ¶ 33.) Therefore, Plaintiff alleges, “Cephalon must bear
the burden for any injuries that [D]ecedent sustained as a result of Dr. Lonberg’s prescription of,
and failure to warn [D]ecedent of the risks of, TRENDA, in reliance on Cephalon’s false
representation.” (Id. ¶ 33.)
Defendant's proffered basis for dismissal of the negligent misrepresentation claim is that
Decedent was not in privity, or any relationship approaching privity, with Defendant, and that
the Amended Complaint does not allege that Decedent was a “known party” to Defendant or that
Defendant undertook conduct linking it to him. See DiBartolo, 914 F. Supp. 2d at 624
(explaining that absent privity, a negligent misrepresentation claimant must allege “(1) an
awareness by the maker of the statement that it is to be used for a particular purpose; (2) reliance
by a known party on the statement in furtherance of that purpose; and (3) some conduct by the
maker of the statement linking it to the relying party and evincing its understanding of that
reliance”); see also Sullivan v. Aventis, Inc., No. 14-cv-2939-NSR, 2015 WL 4879112, at *9
(S.D.N.Y. Aug. 13, 2015) (same).
Similarly to the plaintiff in DiBartolo, Plaintiff cannot satisfy the elements of a claim for
negligent misrepresentation because she and/or the Decedent were not in privity of contract with
Cephalon, and there are no allegations that Plaintiff or Decedent was a “known party” to
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Cephalon or that Cephalon undertook special conduct linking it to them. The Amended
Complaint sets forth no allegations regarding any communication between Cephalon and
Plaintiff or Decedent. Plaintiffs only proffered basis for the existence ofprivity is that
Decedent's insurance company purchased TREANDA from Cephalon on his behalf, acting as his
agent. (Pl.'s Opp'n at 24; Deel. of Jeffrey S. Baker iJ 4.) But this is not alleged in the Amended
Complaint and Plaintiff cites to no authority for the proposition that this form of transaction or
relationship establishes privily of contract. Instead, generally "privily does not exist between
manufacturers and patients when the medication is only available by prescription." Dimieri v.
i\!Jedicis Pharm. Corp., No. 2:14-CV-176-FTM-38, 2014 WL 3417364, at *6 (M.D. Fla. July 14,

2014); see also DiBartolo, 914 F. Supp. 2d at 624 (dismissing negligent misrepresentation claim
because plaintiff was not in privity of contract with prescription drug manufacturer).

CONCLUSION
For the foregoing reasons, Defendants' motion to dismiss is granted. The Comt
respectfully directs the Clerk to terminate the motion at ECF No. 25 and to terminate the case in
accordance with this Opinion.

Dated:

September 15, 2015
White Plains, New York

SO ORDERED:

~

United States District Judge

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