In re: Avandia Marketing v. , 588 F. App'x 171 ( 2014 )

NOT PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
___________
No. 13-4323
___________
IN RE: AVANDIA MARKETING SALES PRACTICES
& PRODUCTS LIABILITY LITIGATION
RICHARD V. D’APUZZO, on behalf of himself
and all others similarly situated,
Appellant
_______________________
On Appeal from the District Court
for the Eastern District of Pennsylvania
D.C. Civil No. 2-07-cv-04963 and 2-07-md-01871
(Honorable Cynthia M. Rufe)
______________
Argued: April 7, 2014
Before: FISHER, SCIRICA, and COWEN, Circuit Judges
(Filed: October 21, 2014)
Gary M. Meyers, Esq. [ARGUED]
35 West Main Street
Suite 106
Denville, NJ 07834
Counsel for Appellant
Anthony C. Vale, Esq.
Gabriel J. Vidoni, Esq. [ARGUED]
Pepper Hamilton
18th & Arch Streets
3000 Two Logan Square
Philadelphia, PA 19103
Counsel for Appellee
_________________
OPINION OF THE COURT
_________________
SCIRICA, Circuit Judge.
At issue in this diversity action is whether plaintiff has stated a claim under
Federal Rule of Civil Procedure 12(b)(6) for breach of express warranty under New
Jersey law. The trial court granted defendant’s motion to dismiss, and plaintiff appeals.1
We will affirm.2
I.
Richard V. D’Apuzzo, who suffers from Type 2 diabetes mellitus, filed suit
alleging GlaxoSmithKline LLC (“GSK”) caused him economic harm by misrepresenting
1
We exercise plenary review over a district court’s ruling on a Rule 12(b)(6) motion to
dismiss. Byers v. Intuit, Inc., 600 F.3d 286, 291 (3d Cir. 2010). A federal court sitting in
diversity must apply state substantive law and federal procedural law. See Liggon-
Redding v. Estate of Sugarman, 659 F.3d 258, 262 (3d Cir. 2011) (citing Erie R.R. v.
Tompkins, 304 U.S. 64, 78 (1938)).
2
The District Court had diversity jurisdiction under 28 U.S.C. § 1332. We have
appellate jurisdiction under 28 U.S.C. § 1291.
2
the safety and efficacy of its diabetes drug Avandia.3 D’Apuzzo does not allege Avandia
harmed him physically or that he experienced any cardiovascular injury. Instead,
D’Apuzzo contends he would have paid less for safer, more effective insulin had GSK
not expressly warranted Avandia to be safe and effective in treating type 2 diabetes.
App. 25, 80. Specifically, he contends Avandia was approximately twenty-two times
more expensive than older available drugs, such as insulin, that were often more effective
and better tolerated than Avandia. App. 23. D’Apuzzo seeks damages for the higher
cost, including co-payments, he paid for Avandia as a result of GSK’s warranty that the
drug was safe and effective. D’Apuzzo claims GSK breached an express warranty
because Avandia is neither safe nor effective in treating diabetic patients like him when
taking into account glycemic control and risk factors. Yet D’Apuzzo does not allege that
Avandia caused him harm or was ineffective for him.
D’Apuzzo filed his initial class action complaint4 on July 13, 2007, and his first
amended complaint on October 24, 2007, both in the U.S. District Court for the District
of New Jersey. The case was then transferred to the U.S. District Court for the Eastern
District of Pennsylvania as part of MDL No. 1871 pursuant to an order from the Judicial
3
Approved by the Food and Drug Administration on May 25, 1999, as an oral
antidiabetic agent, Avandia is recommended and prescribed for the management of type 2
diabetes mellitus (also referred to as non–insulin-dependent diabetes or adult-onset
diabetes).
4
D’Apuzzo sought to include in the class patients who were prescribed and purchased
Avandia (rosiglitazone maleate) and two related pharmaceuticals manufactured by
GSK—Avandamet (a combination of rosiglitazone maleate and metformin) and
Avandaryl (a combination of rosiglitazone maleate and glimepiride)—in New Jersey after
May 25, 1999. The District Court dismissed the case before making any decision on
class certification.
3
Panel on Multidistrict Litigation.5 On June 6, 2010, D’Apuzzo filed his second amended
complaint, alleging violations of the New Jersey Consumer Fraud Act and unjust
enrichment. On September 7, 2011, on GSK’s motion, the District Court dismissed
D’Apuzzo’s second amended complaint without prejudice. On October 25, 2011,
D’Apuzzo filed his third amended complaint, alleging violations of the New Jersey
Consumer Fraud Act, breach of express warranty, breach of implied warranty, fraud,
negligent misrepresentation, negligence, and unjust enrichment. GSK moved to dismiss
the third amended complaint under Rule 12(b)(6).
On October 15, 2013,6 the District Court granted GSK’s Rule 12(b)(6) motion to
dismiss the entire complaint with prejudice, concluding it would be inequitable to permit
D’Apuzzo a fourth opportunity to state a claim. The District Court dismissed all but one
of D’Apuzzo’s claims—for violations of the New Jersey Consumer Fraud Act, breach of
implied warranty, fraud, negligent misrepresentation, negligence, and unjust
enrichment—as barred by the New Jersey Products Liability Act (“PLA”), N.J. Stat. Ann.
§§ 2A:58C-1 et seq., which is the exclusive basis for any New Jersey products liability
5
D’Apuzzo’s case is one of approximately 4,900 Avandia lawsuits centralized in the
United States District Court for the Eastern District of Pennsylvania under MDL No.
1871. In centralizing these suits, the Judicial Panel on Multidistrict Litigation noted the
actions “arise from allegations that certain diabetes drugs manufactured by GSK—
Avandia and/or two sister drugs containing Avandia (Avandamet and Avandaryl)—cause
an increased risk of heart attack and other physical injury, and that GSK failed to provide
adequate warnings concerning that risk.” In re Avandia Mktg., Sales Practices and
Prods. Liab. Litig., 528 F. Supp. 2d 1339, 1340–41 (J.P.M.L. 2007). As noted,
D’Apuzzo does not allege he suffered physical injury as a result of taking Avandia.
6
On July 10, 2013, the District Court issued a memorandum opinion and order
dismissing D’Apuzzo’s complaint. It vacated that order on July 24, 2013, and issued a
revised memorandum opinion and order dismissing the case on October 15, 2013.
4
action, except for express warranty and environmental tort actions.7 App. 3-4.
D’Apuzzo does not appeal the dismissal of those claims.8
The District Court also dismissed D’Apuzzo’s express warranty claim—which is
explicitly exempt from the ambit of the PLA—for failure to allege the “exact text of the
warranties, or the precise time periods these warranties were in effect.” App. 5.
D’Apuzzo filed this timely appeal, in which the only ruling he challenges is the dismissal
of his express warranty claim.
D’Apuzzo contends GSK “expressly warranted on its labels and packaging to
Plaintiffs, prescribers, and patients, that Avandia would provide assist [sic] ‘in the
7
The PLA defines a “product liability action” as “any claim or action brought by a
claimant for harm caused by a product, irrespective of the theory underlying the claim,
except actions for harm caused by breach of an express warranty.” N.J. Stat. Ann.
§ 2A:58C-1(b)(3). The PLA “is both expansive and inclusive, encompassing virtually all
possible causes of action relating to harms caused by consumer and other products.” In
re Lead Paint Litig., 924 A.2d 484, 503 (N.J. 2007). A plaintiff cannot circumvent the
PLA by asserting other causes of action stemming from harm caused by a product if
those causes of action are not excluded from the PLA’s ambit. See, e.g., Repola v.
Morbark Indus., Inc., 934 F.2d 483, 492 (3d Cir. 1991) (“We . . . predict that the New
Jersey Supreme Court would hold that the [PLA] generally subsumes common law
product liability claims, thus establishing itself as the sole basis of relief under New
Jersey law available to consumers injured by a defective product.”); Arlandson v. Hartz
Mountain Corp., 792 F. Supp. 2d 691, 702–04 (D.N.J. 2011); Sinclair v. Merck & Co.,
948 A.2d 587, 595–96 (N.J. 2008); Bailey v. Wyeth, Inc., 37 A.3d 549, 582–84 (N.J.
Super. Ct. Law Div. 2008), aff’d sub nom. DeBoard v. Wyeth, Inc., 28 A.3d 1245 (N.J.
Super. Ct. App. Div. 2011).
8
The PLA requires a plaintiff to have suffered (a) physical damage to property (other
than to the product itself), (b) personal physical injury, (c) pain and suffering or
emotional harm, or (d) any loss of consortium or services deriving from these types of
harm. N.J. Stat. Ann. § 2A:58C-1(b)(2). As noted, D’Apuzzo only alleges he suffered
economic loss—the amount of money he paid for Avandia, including insurance co-
payments—and does not allege he suffered any physical injury. See Sinclair, 948 A.2d at
595 (rejecting claim for economic loss under the PLA for failure to allege physical
injury).
5
management of type 2 diabetes mellitus’ in a safe and efficacious manner.” 9 Ohio App. 80.
But D’Apuzzo does not allege GSK made unqualified or absolute guarantees of
Avandia’s safety and efficacy. Nor could he make such an allegation given that the
“express warranty” contained in Avandia’s “labels and packaging” consists of much
more than “safe and effective.” The Avandia label discloses contraindications, risk
factors, and potential side effects of taking the drug, thereby warning it may not be safe
under all circumstances for every person. The Avandia label in effect when D’Apuzzo
started taking the drug in October 2002 warned, among other things, that (1) Avandia
could exacerbate congestive heart failure, (2) patients at risk for heart failure should be
monitored, and (3) Avandia was contraindicated for patients with New York Heart
Association Class III and IV cardiac status.10 The label was revised in 2003 to more
prominently feature the cardiac side effects warning and to include data from clinical
studies indicating that Avandia could increase the risk of cardiovascular events. 11 GSK
later added to the label a black box warning of the risk of congestive heart failure and
myocardial infarction (heart attack).12 Even with these potential side effects, Avandia
9
D’Apuzzo’s factual allegations are taken from his third amended complaint.
10
See Avandia Approval History, NDA 021071, Apr. 3, 2000, Label, FDA,
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia_prntlbl.
pdf.
11
See Avandia Approval History, NDA 021071, Feb. 27, 2003, Label, FDA, http://www.
accessdata.fda.gov/drugsatfda_docs/label/2003/021071s004lbl.pdf.
12
See Avandia Approval History, NDA 021071, Aug. 14, 2007, Feb. 3, 2011, Labels,
FDA, www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s028lbl.pdf (Aug. 14,
2007, label), www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,
021410s026,021700s010lbl.pdf (Feb. 3, 2011, label).
6
remains on the market today.13
II.
A.
Under Federal Rule of Civil Procedure 12(b)(6), we assume plaintiff’s well-
pleaded, nonconclusory factual allegations to be true. See Ashcroft v. Iqbal, 556 U.S.
662, 678–79 (2009). D’Apuzzo contends he adequately pleaded his express warranty
claim because (1) New Jersey law does not require the use of particular language for the
creation of an express warranty and (2) his third amended complaint referenced general
representations of safety and efficacy contained in Avandia’s labeling and package
inserts as the source of the express warranty. The District Court disagreed, concluding
that D’Apuzzo’s failure “to allege the exact text of the warranties, or the precise time
periods these warranties were in effect” was fatal to his express warranty claim. App. 5.
We agree with the District Court that D’Apuzzo’s allegations were general and vague.
But we need not decide whether D’Apuzzo was required to provide the exact text and
time period of the warranties because we can decide this case on another ground—
D’Apuzzo’s failure to state an express warranty claim as a matter of New Jersey law. See
Brightwell v. Lehman, 637 F.3d 187, 191 (3d Cir. 2011) (“We may affirm a district court
for any reason supported by the record.”). Our decision turns not on the federal pleading
standard and whether D’Apuzzo adequately pleaded the content of the express warranty
he alleged, but instead on whether the language of GSK’s label creates an express
13
See Drug Details—Avandia, FDA, www.accessdata.fda.gov/scripts/cder/drugsatfda/
index.cfm?fuseaction=Search.Overview&DrugName=Avandia (last visited Sept. 12,
2014).
7
warranty under New Jersey law.14 Because we conclude the statement that Avandia is
“safe and effective” for its intended use contained on its label disclosing
contraindications, risk factors, and potential side effects of the drug is not sufficient as a
matter of law to state a New Jersey express warranty claim, we will affirm.
B.
D’Apuzzo must state a valid express warranty claim as a matter of New Jersey
substantive law to avoid dismissal.15 In order to state a claim for breach of express
warranty under New Jersey law, plaintiff must allege (1) GSK made an affirmation of
fact, promise, or description about the product; (2) this affirmation of fact, promise, or
description became part of the basis of the bargain for the product; and (3) the product
ultimately did not conform to the affirmation of fact, promise, or description. See N.J.
Stat. Ann. § 12A:2-313. Under New Jersey law, “guarantees of future performance
should be specific.” See Herbstman v. Eastman Kodak Co., 342 A.2d 181, 187 (N.J.
1975). To create an express warranty, the seller need not use formal words such as
“warrant” or “guarantee” or have a specific intention to make a warranty. N.J. Stat. Ann.
§ 12A:2-313. But that does not mean D’Apuzzo is relieved from identifying the
affirmation of fact, promise, or description he contends constitutes the express warranty
14
Because D’Apuzzo’s complaint explicitly refers to Avandia’s “labels” and those
documents are publicly available on the FDA’s website, we may take judicial notice of
the labels’ content. S. Cross Overseas Agencies, Inc. v. Wah Kwong Shipping Grp. Ltd.,
181 F.3d 410, 426–27 (3d Cir. 1999); see also, e.g., Pryor v. NCAA, 288 F.3d 548, 559–
60 (3d Cir. 2002). We do so here not in the ordinary course but because, for the reasons
described below, D’Apuzzo’s express warranty claim cannot proceed under New Jersey
substantive law regardless of how it is pleaded.
15
Following oral argument, plaintiff requested we certify the question to the Supreme
Court of New Jersey. We denied the motion.
8
under New Jersey law. Id.
For the first time on appeal—but in none of his complaints—D’Apuzzo focuses on
one statement from a 2007 Avandia label that he alleges created an express warranty:
“The 8 mg daily dose has been shown to be safe and effective in clinical studies as
monothereapy [sic] and in combination with metformin, sulfonylurea, or sulfonylurea
plus metformin.”16 Appellant Br. 21.17
This statement asserts only that a particular dose of Avandia has been shown to be
safe and effective in clinical studies.18 FDA regulations required GSK to disclose the
highest dose for which the safety and efficacy of Avandia had been established in clinical
trials. See 21 C.F.R. § 201.57(c)(3)(i)(B) (noting prescription drug labeling must identify
an upper limit dose beyond which the safety and effectiveness of the drug have not been
16
Two cases on which D’Apuzzo relies serve only to highlight his failure to identify with
specificity the affirmation of fact, promise, or description he contends is the express
warranty. See Stewart v. Smart Balance, Inc., No. 11-6174, 2012 WL 4168584, at *11–
12 (D.N.J. June 26, 2012) (refusing to dismiss breach of express warranty claim alleging
defendants sold milk labeled “fat free” that failed to meet federal regulations for fat-free
milk); In re Ford Motor Co. E-350 Van Prods. Liab. Litig. (No. II), No. 03-4558, 2008
WL 4126264, at *3–5 (D.N.J. Sept. 2, 2008) (refusing to dismiss breach of express
warranty claim alleging Ford marketed vans as “15-passenger” that could not safely
transport 15 passengers). Unlike D’Apuzzo’s general allegations against GSK, plaintiffs
in these cases pointed to specific affirmations of fact or descriptions—“fat free” and “15-
passenger”—that they alleged constituted express warranties.
17
Typically, D’Apuzzo’s citation to this passage for the first time in his appellate brief
would be improper and we would decline to consider it. See United States ex rel. Wilkins
v. United Health Grp., Inc., 659 F.3d 295, 303 (3d Cir. 2011) (“[O]rdinarily a court of
appeals should not take judicial notice of documents on an appeal which were available
before the district court decided the case but nevertheless were not tendered to that
court.”). But in this case we will consider the passage because it comes from a 2007
Avandia label of which we have taken judicial notice.
18
Plaintiff’s complaint fails to specify the particular dose of Avandia he took.
9
established or increased doses do not result in increased effectiveness).19 And the
statement D’Apuzzo cites, when considered alone, does not claim Avandia will be safe
and effective in every case for every consumer.
Nor could it be read to make that claim when considering the entirety of the
Avandia label. See Gladden v. Cadillac Motor Car Div., Gen. Motors Corp., 416 A.2d
394, 397 (N.J. 1980) (determining whether an express warranty was created by
evaluating an owner’s guide and guarantee document in its entirety). Crucially,
Avandia’s labeling discloses contraindications, risk factors, and possible side effects of
the drug, thereby indicating the drug might prove dangerous or ineffective for some
people. The August 14, 2007 Avandia label discloses, among other things, that Avandia
is contraindicated for patients with New York Heart Association Class III or IV heart
failure, may increase the risk of cardiac failure or other cardiac effects, should be used
with caution in patients with edema, may increase the risk of hypoglycemia, may cause
weight gain, may increase the risk of bone fractures in women, and may increase the risk
of pregnancy. See Avandia Approval History, NDA 021071, Aug. 14, 2007, Label, FDA,
www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s028lbl.pdf. These
contraindications, risk factors, and possible side effects are the primary reasons
D’Apuzzo required a prescription to obtain Avandia. Because GSK disclosed Avandia’s
contraindications, risk factors, and possible side effects on the drug’s label, the statement
19
The FDA regulates the approval and labeling of new drugs. As part of the approval
process, the FDA evaluates a new drug’s safety and effectiveness as well as its proposed
labeling. See Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2470–71 (2013); see also 21
U.S.C. § 355; 21 C.F.R. § 201.5.
10
on that same label that the 8 mg dose of Avandia has been shown in clinical trials to be
“safe and effective” for its intended use cannot be read as an unqualified guarantee that
Avandia would be safe and effective for all consumers.
No New Jersey authority directly addresses the question of whether the statement
that Avandia is “safe and effective” for its intended use—contained on a label disclosing
contraindications, risk factors, and potential side effects—is sufficient to create an
express warranty under New Jersey law. Accordingly, we interpret New Jersey law as
we predict it would be interpreted by the Supreme Court of New Jersey. See Travelers
Indem. Co. v. Dammann & Co., 594 F.3d 238, 244 (3d Cir. 2010). “In making such a
prediction, we . . . consider relevant state precedents, analogous decisions, considered
dicta, scholarly works, and any other reliable data tending convincingly to show how the
highest court in the state would resolve the issue at hand.” Id. (internal quotation marks
and citation omitted).
New Jersey’s express warranty statute follows section 2-313 of the Uniform
Commercial Code. Compare N.J. Stat. Ann. § 12A:2-313, with U.C.C. § 2-313.
Connecticut’s and Ohio’s express warranty statutes also follow section 2-313,20 and
courts interpreting the law of these states have refused to find the words “safe and
effective” to create an express warranty in the absence of representations that a drug was
free from all harmful side effects or was absolutely harmless. See Basko v. Sterling
Drug, Inc., 416 F.2d 417, 428 (2d Cir. 1969) (“[W]e need say only that defendant did not
represent either (1) that its drugs were free from all harmful side effects or (2) that its
20
See Conn. Gen. Stat. Ann. § 42a-2-313; Ohio Rev. Code Ann. § 1302.26.
11
drugs were absolutely harmless.”); Fraser v. Wyeth, Inc., 857 F. Supp. 2d 244, 257–58
(D. Conn. 2012) (“[A] drug manufacturer’s representation in advertising or a warning
label that a product is safe and effective, or an advertisement or warning label that does
not adequately highlight a particular known or knowable risk does not create an express
warranty in the absence of a guarantee that the particular product is free from all harmful
side effects.”); In re Meridia Prods. Liab. Litig., 328 F. Supp. 2d 791, 818 (N.D. Ohio
2004) (finding under Ohio law that “asserting that a product is ‘safe and effective’ is not
sufficiently clear to create an express warranty”). These authorities are consistent with
the well-established principle that “safe and effective” are relative terms in the
pharmaceutical industry—“safe” drugs harm some people and “effective” drugs do not
work in every case. See Bailey v. Wyeth, Inc., 37 A.3d 549, 554 n.8 (N.J. Super. Ct. Law
Div. 2008) (noting the FDA concedes “no drug is absolutely safe [and] all drugs have
side effects” and defines “safe” to mean “the benefits of the drug appear to outweigh the
risks” (internal quotation marks omitted)); 21 C.F.R. § 201.57 (noting effective means
there is substantial evidence of the drug’s effectiveness based on adequate, well-
controlled clinical studies).21
21
These cases should not be read as foreclosing express warranty claims against
pharmaceutical manufacturers or retailers. In certain circumstances, courts have found
express warranties with respect to drug safety. See Rite Aid Corp. v. Levy-Gray, 894
A.2d 563, 570–72 (Md. 2006) (concluding a package insert instructing patients to “[t]ake
with food or milk if stomach upset occurs” could constitute an express warranty and
noting that Basko v. Sterling Drug, Inc., 416 F.2d 417, “do[es] not support the
proposition that there can never be an express warranty with respect to prescription
drugs”); Grinnell v. Charles Pfizer & Co., 79 Cal. Rptr. 369, 377–78 (Dist. Ct. App.
1969) (finding that a package insert indicating that “‘[t]here are no known
contraindications to oral polio virus vaccines” was an affirmation of fact that constituted
an express warranty).
12
Our decision in Cipollone v. Liggett Group, Inc., 893 F.2d 541, 574–76 (3d Cir.
1990), aff’d in part, rev’d in part on other grounds, 505 U.S. 504 (1992), is consistent
with these cases interpreting Connecticut and Ohio law. In Cipollone, the plaintiff cited
specific representations made in Chesterfield cigarette advertisements. One
advertisement stated, without qualification, that “NOSE, THROAT, and Accessory
Organs [are] not Adversely Affected by Smoking Chesterfields.” Id. at 575. Another
advertisement cited a study that purportedly showed “proof” that Chesterfield cigarettes
“never . . . did you any harm.” Id. Other advertisements suggested consumers should
“PLAY SAFE” and “Smoke Chesterfield” and described cigarettes as “just what the
doctor ordered.” Id. We concluded that under New Jersey law a “reasonable jury could
infer that an unqualified representation that smoking is safe creates a warranty that
smoking for a long period of time is safe.” Id. at 576. Unlike the plaintiff in Cipollone,
D’Apuzzo does not allege GSK made unqualified promises or affirmations of fact
regarding Avandia.
Marko v. Sears, Roebuck & Co., 94 A.2d 348 (N.J. Super. Ct. App. Div. 1953),
similarly involved absolute assurances of safety. In that case, the plaintiff was injured
when a lawnmower kept operating upon striking a rock despite a salesman’s assurances
the mower was “absolutely safe” and would stop operation upon contacting an obstacle.
Id. at 349. The court found plaintiff made out a breach of express warranty claim
because “[u]nder the warranty in question . . . plaintiff had a right to expect that when the
mower struck the rock the blade would stop revolving and the machine would stop
operating.” Id. at 350. Unlike in Marko, D’Apuzzo has not alleged GSK promised
13
Avandia would be safe for all consumers, and GSK’s disclosure of Avandia’s
contraindications, risk factors, and potential side effects on the drug’s label indicates
GSK did not make such an unqualified guarantee.
Although some courts have permitted express warranty claims based on the
representation that a drug or medical device was safe and effective, these cases involved
more substantial representations than those at issue here. See, e.g., Knipe v. SmithKline
Beecham, 583 F. Supp. 2d 602, 625–26 (E.D. Pa. 2008) (refusing to dismiss express
warranty claim on summary judgment where plaintiff alleged manufacturer represented
the drug to be safe and effective in “various articles, conferences, and journals presented
to the medical community” and had made specific statements regarding the drug’s safety
and efficacy in a particular group); Simonet v. SmithKline Beecham Corp., 506 F. Supp.
2d 77, 88–89 (D.P.R. 2007) (refusing to grant motion to dismiss where plaintiff alleged
manufacturer made representations regarding its tablets’ dissolution rate and controlled-
release effect in numerous sources but defects in the tablets caused them not to function
as described); Palmer v. A.H. Robins Co., 684 P.2d 187, 207–08 (Colo. 1984) (finding a
jury could reasonably have concluded that manufacturer’s representations regarding a
medical device—including that it could “prevent pregnancy without producing any
general effects on the body, blood or brain”—could constitute an express warranty). By
contrast, D’Apuzzo alleges only that GSK represented Avandia as “safe and efficacious”
in one source—Avandia’s “labels and packaging”—and on appeal points to only one
qualified statement on the label. See In re Meridia Prods. Liab. Litig., 328 F. Supp. 2d at
818 (determining under Ohio law that a manufacturer’s representation of a drug as “safe
14
and effective”—without more substantial factual allegations by plaintiffs—did not
constitute an express warranty).
Because GSK disclosed Avandia’s contraindications, risk factors, and potential
side effects and D’Apuzzo does not allege GSK made unqualified guarantees of safety or
effectiveness, D’Apuzzo has failed as a matter of New Jersey law to state an express
warranty claim.
C.
At oral argument, D’Apuzzo contended GSK also breached the alleged express
warranty because the company failed to disclose or understated known cardiac risks that
rendered Avandia potentially dangerous to consumers. This argument is unavailing
because it is an attempt to argue a failure to warn cause of action in an express warranty
appeal.
Failure to warn and express warranty are different causes of action. See, e.g.,
Cipollone, 505 U.S. at 524–25 (analyzing failure to warn and express warranty claims as
separate causes of action). A failure to warn claim is a type of product liability action
governed by the New Jersey Products Liability Act. See Cornett v. Johnson & Johnson,
48 A.3d 1041, 1055 (N.J. 2012) (noting the PLA defines an adequate product warning as
“one that a reasonably prudent person in the same or similar circumstances would have
provided with respect to the danger and that communicates adequate information on the
dangers and safe use of the product” (internal quotation marks omitted)).
But D’Apuzzo’s appeal is based on express warranty, which is specifically
excluded from the scope of the PLA because it is not a product liability cause of action.
15
See N.J. Stat. Ann. § 2A:58C-1b(3) (“‘Product liability action’ means any claim or action
brought by a claimant for harm caused by a product, irrespective of the theory underlying
the claim, except actions for harm caused by breach of an express warranty.”).
D’Apuzzo never raised a failure to warn claim, and he cannot raise that claim for the first
time in this appeal of the dismissal of his express warranty cause of action. See, e.g.,
Freeman v. Pittsburgh Glass Works, LLC, 709 F.3d 240, 249 (3d Cir. 2013) (“We
generally refuse to consider issues that the parties have not raised below.”).
Accordingly, we reject D’Apuzzo’s attempt to advance a failure to warn cause of
action in this express warranty appeal.
III.
Because D’Apuzzo has not stated a claim for breach of express warranty under
New Jersey law, we will affirm the District Court’s dismissal of D’Apuzzo’s express
warranty claim under Federal Rule of Civil Procedure 12(b)(6).
16