Sneed et al v. Bristol-Myers Squibb et al
OPINION AND ORDER: The defendants October 5 motion to dismiss is granted in part. The design defect claims are dismissed with prejudice. The plaintiffs are given leave to amend their remaining claims. A separate scheduling order accompanies this Opinion. (Signed by Judge Denise Cote on 12/23/2016)(gr)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
CHARLIE UTTS and CIARA UTTS,
BRISTOL-MYERS SQUIBB COMPANY and
OPINION AND ORDER
For Charlie Utts and Ciara Utts:
Napoli Shkolnik PLLC
400 Broadhollow Road
Melville, New York 11747
For Bristol-Myers Squibb Company and Pfizer Inc.:
Loren H. Brown
Cara D. Edwards
DLA Piper LLP (US)
1251 Avenue of the Americas
New York, New York 10020
DENISE COTE, District Judge:
Plaintiffs Charlie and Ciara Utts bring this product
liability lawsuit against defendants Bristol-Myers Squibb
Company (“BMS”) and Pfizer Inc. (“Pfizer”), alleging that Mr.
Utts suffered severe internal bleeding caused by taking Eliquis,
a prescription drug manufactured, marketed, and distributed by
The defendants have moved to dismiss the
complaint pursuant to Federal Rules of Civil Procedure 12(b)(6)
For the following reasons, the defendants’ motion is
largely granted, with leave to amend most of the dismissed
The following facts are drawn from the complaint and
documents integral to it, including the Eliquis label approved
by the Federal Drug Administration (“FDA”).
construed in favor of the plaintiffs.
The facts are
See Keiler v. Harlequin
Enters. Ltd., 751 F.3d 64, 68 (2d Cir. 2014).
Plaintiffs Charlie and Ciara Utts are both residents of
Mr. Utts was diagnosed with atrial fibrillation1
some time before July 2014 and prescribed Eliquis by his doctor.
Mr. Utts suffered severe internal bleeding after taking Eliquis.
Eliquis -- the brand name of the prescription medicine
apixaban -- is an anticoagulant, blood-thinning medication used
to reduce the risk of stroke and systemic embolism in patients
with nonvalvular atrial fibrillation.
anticoagulant medications such as warfarin, Eliquis does not
have a known antidote or reversal agent.
It does, however, have
Atrial fibrillation is a common arrhythmia (i.e., abnormal
heart beat) that causes blood clots to form in the heart.
Individuals with atrial fibrillation are at a high risk of
stroke and use medications such as Eliquis to reduce the risk of
certain marked advantages over other anticoagulant medications.
For example, Eliquis does not require periodic blood testing,
nor does it impose dietary restrictions on its users.
FDA Approval of Eliquis
The FDA approved Eliquis for sale and marketing in the
United States in 2012.
Pursuant to federal law, all
applications for FDA approval of new drugs must include a
description of the clinical investigations of the drug,
including an analysis of each clinical pharmacology study of the
drug and each controlled clinical study pertinent to a proposed
use of the drug.
See 21 C.F.R. § 314.50(d)(5).
with this requirement, the defendants submitted the results of
the international clinical trials known as ARISTOTLE.
plaintiffs allege several deficiencies with the ARISTOTLE study,
including the defendants’ use of “incompetent and untrustworthy
agents in China to conduct the ARISTOTLE study.”
further contend that the defendants concealed several side
effects experienced by study participants.2
While the defendants’ application was pending before the
FDA, Dr. Thomas Marcinak, an FDA employee appointed to review
The allegedly concealed side effects include: (1) an unreported
death; (2) loss of subjects to follow-up; (3) major dispensing
errors including indicating that certain subjects were receiving
Eliquis when they were not; (4) poor overall quality control;
and (5) changing and falsifying records, including records
disappearing just before the FDA conducted a site visit.
the Eliquis application, recommended that the proposed Eliquis
label discuss the quality control problems associated with the
In response to concerns about the rigor of the
ARISTOTLE study, the defendants stated that they were submitting
additional data to the FDA for its consideration.
The Eliquis Label
At the time Mr. Utts was prescribed Eliquis, the label
contained several warnings about the risk of bleeding.
example, the “Warnings and Precautions” section of the label
provides, under a subheading entitled “Bleeding,” that:
ELIQUIS increases the risk of bleeding and can cause
serious, potentially fatal, bleeding. . . . There is
no established way to reverse the anticoagulant effect
of apixaban, which can be expected to persist for
about 24 hours after the last dose, i.e., for about
two half-lives. A specific antidote for ELIQUIS is
The “Adverse Reactions” section further provides that
“[t]he most serious adverse reactions reported with ELIQUIS
were related to bleeding,” while the “Overdosage” section
noted that “[t]here is no antidote to ELIQUIS.
ELIQUIS increases the risk of bleeding.”
“Patient Counseling Information” section instructs
physicians to inform their patients that “it might take
longer than usual for bleeding to stop,” and that “they may
bruise or bleed more easily when treated with ELIQUIS.”
The label also instructs physicians to “[a]dvise patients
about how to recognize bleeding or symptoms of hypovolemia
and of the urgent need to report any unusual bleeding to
The Eliquis label specifically references the
It provides that “[t]he safety of ELIQUIS
was evaluated in the ARISTOTLE and AVERROES studies,” and
that the “most common reason for treatment discontinuation
in both studies was for bleeding-related adverse
It notes that “in ARISTOTLE this occurred in
1.7% and 2.5% of patients treated with ELIQUIS and
warfarin, respectively, and in AVERROES, in 1.5% and 1.3%
on ELIQUIS and aspirin, respectively.”
Finally, the Eliquis Medication Guide -- a paper
insert in all prescription medicine packages -- instructs
patients that “ELIQUIS can cause bleeding which can be
serious and rarely may lead to death.
This is because
ELIQUIS is a blood thinner medicine that reduces blood
clotting.” (Emphasis in original.)
III. Procedural History
The plaintiffs filed their complaint on July 15, 2016.
complaint asserts twelve causes of action against the
defendants: (1) product liability - design defect; (2) product
liability - manufacturing defect; (3) product liability 5
failure to warn; (4) product liability - strict liability; (5)
negligence; (6) breach of express warranty; (7) breach of
implied warranties; (8) fraudulent concealment; (9) negligent
misrepresentation; (10) fraud; (11) violation of consumer
protection laws; and (12) loss of consortium on behalf of Mrs.
On October 5, the defendants filed a motion to dismiss
under Rules 12(b)(6) and 9(b).
On October 13, the
defendants moved the Judicial Panel on Multidistrict
Litigation (“JPML”) to transfer and coordinate 34 actions
pending in 13 different district courts, including the
instant action, pursuant to 28 U.S.C. § 1407.
21, the parties in the instant action filed a letter
requesting that the Honorable Lewis A. Kaplan stay all
proceedings pending resolution of the JPML petition.
request to enter a stay was denied on October 28.
On November 21, the case was reassigned to this Court
as related to 16 other product liability cases concerning
the medication Eliquis that have been filed in this
That same day, this Court issued an Order
instructing the parties in this case and all related
The parties had requested that litigation be stayed in each of
this district’s actions until the JPML rules on the defendants’
motion to transfer. As a result, only the motion to dismiss
filed in the instant action has been fully briefed.
actions to confer and identify one motion that is
appropriate for early resolution.
The November 21 Order
also explained that the initiation of discovery would turn
on whether or not the Court denies the selected motion to
On December 2, the parties identified the present
motion to dismiss as the one motion appropriate for early
The motion to dismiss became fully submitted
on December 5.
When deciding a motion to dismiss, a court must “accept all
allegations in the complaint as true and draw all inferences in
the non-moving party’s favor.”
LaFaro v. New York
Cardiothoracic Grp., PLLC, 570 F.3d 471, 475 (2d Cir. 2009)
“To survive a motion to dismiss under Rule
12(b)(6), a complaint must allege sufficient facts which, taken
as true, state a plausible claim for relief.”
Keiler, 751 F.3d
at 68; Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (“[A]
complaint must contain sufficient factual matter, accepted as
true, to state a claim to relief that is plausible on its face.”
A claim has facial plausibility when “the
factual content” of the complaint “allows the court to draw the
reasonable inference that the defendant is liable for the
Tongue v. Sanofi, 816 F.3d 199, 209 (2d
Cir. 2016) (citation omitted).
“Where a complaint pleads facts
that are merely consistent with a defendant’s liability, it
stops short of the line between possibility and plausibility of
entitlement to relief.”
Iqbal, 556 U.S. at 678 (citation
In sum, “a plaintiff’s obligation to provide the
grounds of his entitlement to relief requires more than labels
and conclusions, and a formulaic recitation of the elements of a
cause of action will not do.”
Bell Atl. Corp. v. Twombly, 550
U.S. 544, 555 (2007) (citation omitted).
To satisfy the requirements of Rule 9(b), the
complaint must: (1) detail the events giving rise to the
fraud, such as the statement/omission that is alleged to be
fraudulent, the identity of the speaker, the location of
the fraud, and the reason the statement is fraudulent; and
(2) allege facts “that give rise to a strong inference of
Loreley Fin. (Jersey) No. 3 Ltd. v.
Wells Fargo Sec., LLC, 797 F.3d 160, 171 (2d Cir. 2015)
In deciding a motion to dismiss, the court considers “any
written instrument attached to the complaint as an exhibit or
any statements or documents incorporated in it by reference,”
Stratte-McClure v. Morgan Stanley, 776 F.3d 94, 100 (2d Cir.
2015) (citation omitted), as well as “documents upon which the
complaint relies and which are integral to the complaint.”
Subaru Distribs. Corp. v. Subaru of Am., Inc., 425 F.3d 119, 122
(2d Cir. 2005).
The Eliquis label and package insert are
integral to the complaint.
I. Choice of Law
A district court, sitting in diversity, applies the choice
of law rules of the forum state -- in this case, New York law.
Alphonse Hotel Corp. v. Tran, 828 F.3d 146, 152 (2d Cir. 2016).
Under New York choice of law rules, “the first step in any case
presenting a potential choice of law issue is to determine
whether there is an actual conflict between the laws of the
Licci ex rel. Licci v. Lebanese
Canadian Bank, SAL, 672 F.3d 155, 157 (2d Cir. 2012) (citation
A choice of law analysis need not be performed unless
there is an actual conflict between the applicable rules of
If no actual conflict exists, and
if New York is among the relevant jurisdictions, the court may
simply apply New York law.
Choice of law analysis is conducted on a claim-by-claim
See Fieger v. Pitney Bowes Credit Corp., 251 F.3d 386,
397 n.1 (2d Cir. 2001) (discussing the doctrine of dépeçage).
But, “where the parties agree that a certain jurisdiction’s law
controls, this is sufficient to establish choice of law.”
Alphonse, 828 F.3d at 152 (citation omitted); see also Krumme v.
WestPoint Stevens Inc., 238 F.3d 133, 138 (2d Cir. 2000).
The parties have not performed the first step under New
York’s choice of law analysis, which is to identify whether a
true conflict exists between California and New York law.
defendants, for example, immediately proceed to conduct a choice
of law analysis for the plaintiffs’ contract and tort claims,
apparently on the assumption that there is a conflict between
New York and California law on each cause of action.
their analysis, the defendants conclude that California law
governs the present motion in its entirety.
The plaintiffs, by contrast, simply assert that “New York
and California agree on virtually every aspect of applicable
law” save for design defect claims, but that a “full” choice of
law analysis is “premature at this stage” because “there has
been no discovery as to where Mr. Utts ingested Eliquis” or
where he may have been treated.
The plaintiffs proceed to
analyze their claims under both California and New York law.
Since Mr. Utts presumably knows where he ingested Eliquis,
it is not premature to conduct a choice of law analysis.
Indeed, it is essential to do so to address the pending motion.
Since the complaint recites that Mr. Utts is a citizen and
resident of California, and plaintiffs rely on California law in
opposing this motion, for purposes of this Opinion it is assumed
that the parties have agreed that California law controls.
II. FDA Approval Process
In their motion to dismiss the defendants assert that
several of plaintiffs’ claims are preempted by federal law.
Before describing the law of preemption, it is helpful to
describe in general terms the regulatory scheme that governed
the FDA approval of Eliquis.4
The Food, Drug, and Cosmetic Act of 1938 (“FDCA”) is a
federal law that regulates the manufacture, use, or sale of
Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S.
193, 196 (2005).
Under the FDCA, a drugmaker must submit
research data to the FDA at two general stages of new-drug
First, a drugmaker must gain authorization to
conduct clinical trials (tests on humans) by submitting an
investigational new drug application (“IND”).
355(i); 21 C.F.R. § 312.20-312.21.
See 21 U.S.C. §
The IND must describe
“preclinical tests (including tests on animals) of [the] drug
adequate to justify the proposed clinical testing.”
21 U.S.C. §
355(i)(1)(A); see 21 C.F.R. §§ 312.23(a)(5) and (a)(8)
(specifying necessary information from preclinical tests).
This Opinion is analyzed under FDCA laws and regulations in
existence as of December 5, 2016, when the present motion became
fully submitted. On December 13, 2016, Congress passed the 21st
Century Cures Act, Pub. L. No. 114-255, 130 Stat. 1033. The
parties have not suggested that anything in this new act affects
the law governing the present motion.
Second, to obtain authorization to market a new drug, a
drugmaker must submit a new drug application (“NDA”).
applications must include “full reports of investigations which
have been made to show whether or not such drug is safe for use
and whether such drug is effective in use.”
21 U.S.C. §
To obtain approval under the FDCA, the manufacturer
must demonstrate to the FDA that the drug is “safe for use under
the conditions prescribed, recommended, or suggested in the
Id. § 355(d).
The manufacturer must also
prove the drug’s effectiveness by “substantial evidence that the
drug will have the effect it purports or is represented to have
under the conditions of use prescribed, recommended, or
suggested in the proposed labeling.”
must also submit proposed labeling, with annotations, to be used
with the drug.
Id. § 355(b)(1)(F); 21 C.F.R. § 314.50(c)(2)(i).
The FDA’s premarket approval of an NDA includes the approval of
the exact text in the proposed label.
See 21 U.S.C. § 355; 21
C.F.R. § 314.105(b).
After approval, drug manufacturers have ongoing obligations
to monitor a drug’s risks and to report adverse drug responses
to the FDA.
See 21 C.F.R. §§ 314.80, 314.81, 314.98.
also prohibits the manufacture or distribution of any drug,
whether previously approved for sale by the FDA or not, that is
21 U.S.C. § 352.
A drug is misbranded if, inter
alia, it is “dangerous to health when used in the dosage or
manner, or with the frequency or duration prescribed,
recommended, or suggested in the labeling thereof.”
Where the FDA had previously approved a drug for sale,
the misbranding prohibition applies when there is significant
new scientific evidence demonstrating that the drug is unsafe.
See Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466, 2484
(2013) (Sotomayor, J., dissenting).
The FDCA prohibits a manufacturer from making any major
changes to the “qualitative or quantitative formulation of the
drug product, including inactive ingredients, or in the
specifications provided in the approved NDA.”
21 C.F.R. §
Moderate changes must be reported to the FDA
“at least 30 days prior to distribution of the drug product made
using the change,” id. § 314.70(c) (emphasis added), while minor
changes need only be reported in an annual report to the FDA.5
Id. § 314.70(d)(3).
In addition to regulating changes to the drug formulation,
federal law regulates changes to pharmaceutical labels.
Minor changes that do not require prior notification to and/or
approval from the FDA include “[t]he deletion or reduction of an
ingredient intended to affect only the color of the drug
product” and “[a] change in the size and/or shape of a container
containing the same number of dosage units.” 21 C.F.R. §§
Generally speaking, a manufacturer may only change a drug label
after the FDA approves a supplemental application.
A manufacturer may, however, make certain changes to its
label without prior agency approval through the “changes being
effected” (“CBE”) regulation.
The CBE regulation provides that
if a manufacturer is changing a label to “add or strengthen a
contraindication, warning, precaution, or adverse reaction” for
which there is sufficient “evidence of a causal association,” or
to “add or strengthen an instruction about dosage and
administration that is intended to increase the safe use of the
drug product,” it may make the labeling change upon filing its
supplemental application with the FDA; it need not wait for FDA
Id. §§ 314.70(c)(6)(iii)(A), (C).
Labeling changes pursuant to the CBE regulation may only be
made on the basis of “newly acquired information.”
314.70(c)(6)(iii). “Newly acquired information” is defined as:
[D]ata, analyses, or other information not previously
submitted to the [FDA], which may include (but is not
limited to) data derived from new clinical studies,
reports of adverse events, or new analyses of
previously submitted data (e.g., meta-analyses) if the
studies, events, or analyses reveal risks of a
different type or greater severity or frequency than
previously included in submissions to FDA.
Id. § 314.3(b).
Information previously known to the
manufacturer, but not submitted to the FDA, may constitute
“newly acquired information,” provided that the information
meets the other CBE requirements.
Applications Proposing Labeling Changes for Approved Drugs,
Biologics, and Medical Devices, 73 Fed. Reg. 49603, 49606
The FDA retains the authority to reject labeling
changes made pursuant to the CBE regulations.
Levine, 555 U.S. 555, 571 (2009).
III. Federal Preemption
The defendants argue that federal law preempts many of the
plaintiffs’ claims, including all of the product liability
The Supremacy Clause establishes that federal law
“shall be the supreme Law of the Land . . . any Thing in the
Constitution or Laws of any State to the Contrary
U.S. Const., art. VI, cl.2.
principle of the Constitution is that Congress has the power to
preempt state law.”
U.S. 363, 372 (2000).
Crosby v. Nat’l Foreign Trade Council, 530
State law is preempted by federal law
when: (1) Congress intends federal law to “occupy the field,” or
(2) where state law conflicts with a federal statute.
Conflict preemption exists “where it is impossible for a
private party to comply with both state and federal law.”
“Impossibility pre-emption is a demanding defense.”
U.S. at 573.
Courts must “start with the assumption that the
historic police powers of the States were not to be superseded
by the Federal Act unless that was the clear and manifest
purpose of Congress.”
Id. at 565 (citation omitted).
In a recent trilogy of opinions, the Supreme Court
addressed the issue of conflict preemption in the context of
state product liability claims against drug manufacturers.
first opinion, Wyeth, 555 U.S. 555, analyzed whether a patient’s
state law claim for inadequate warning brought against a brand
name drug manufacturer was preempted by federal law.
two opinions -- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and
Bartlett, 133 S. Ct. 2466 -- addressed issues of preemption as
they pertain to generic drug manufacturers.
state law failure to warn claim.
design defect claim.
Mensing addressed a
Bartlett analyzed a state law
As discussed below, this case law, read
holistically, indicates that federal law preempts all pre-FDA
approval failure to warn and design defect claims for branded
A. Wyeth v. Levine
In Wyeth, the Supreme Court held that federal law did not
preempt a patient’s state law failure to warn claim brought
against a brand name drug manufacturer.
In Wyeth, the plaintiff
received in 2000 an injection of Phenergan, a brand name drug
used to treat nausea.
The drug came in contact with the
plaintiff’s artery, causing gangrene to spread throughout her
arm and resulting in the amputation of the patient’s arm.
plaintiff sued the drug manufacturer, claiming that the labeling
was defective because it failed adequately to warn of the
dangers of administering the drug intravenously using an IVpush, rather than IV-drip, method.
The FDA had approved Wyeth’s
NDA in 1955, over forty years before the plaintiff was injured.
There had been at least twenty reports of amputations similar to
the plaintiff’s since the 1960s, but no evidence that Wyeth had
paid “more than passing attention to the question whether to
warn against IV-push administration” of the drug.
U.S. at 561-63.
In finding that the plaintiff’s state law claims were not
preempted, the Court focused exclusively on how the CBE
regulation permits -- and even requires -- drug manufacturers to
maintain and update their labeling with new safety information
as it becomes available.
See id. at 568-73.
According to the
Court, “the manufacturer bears responsibility for the content of
its label at all times.
It is charged both with crafting an
adequate label and with ensuring that its warnings remain
adequate as long as the drug is on the market.”
Id. at 570-71.
Thus, “when the risk of gangrene from IV-push injection of
Phenergan became apparent,” the manufacturer in Wyeth had a
“duty to provide a warning that adequately described that risk,
and the CBE regulation permitted it to provide such a warning
before receiving the FDA’s approval.”
Id. at 571.
“absent clear evidence that the FDA would not have approved a
change to Phenergan’s label,” the Court would “not conclude that
it was impossible for [the manufacturer] to comply with both
federal and state requirements.”6
Medtronic, Inc. v.
Lohr, 518 U.S. 470, 500 (1996) (providing, in the context of the
Medical Device Amendments of 1976, which contains an express
preemption provision, that “pre-emption occur[s] only where a
particular state requirement threatens to interfere with a
specific federal interest,” and that state requirements “of
general applicability” are not preempted except where they have
“the effect of establishing a substantive requirement for a
specific device,” that relates “to the safety or effectiveness
of the device or to any other matter included in a requirement
applicable to the device” (citation omitted)).
The Court’s conclusion was premised in part on its
understanding of the FDA’s “complementary” role in
regulating drug safety and efficacy.
See id. at 578.
The plaintiffs misinterpret the “clear evidence” standard set
forth in Wyeth. The plaintiffs argue that preemption can be
granted only following discovery that shows “there is ‘clear
evidence’ that the FDA would have rejected the label change.”
But as the Supreme Court again explained in Mensing, only after
a court has found that a manufacturer possessed “newly acquired
information” to support label changes must a manufacturer
demonstrate by “clear evidence” that such proposed changes would
nevertheless have been rejected. Mensing, 564 U.S. at 624 n.8.
Accordingly, in the absence of a plausible allegation that the
manufacturer had “newly acquired information,” it is appropriate
to dismiss a claim under Rule 12(b)(6) as preempted.
the Court explained, the FDCA did not “establish both a
floor and a ceiling for drug regulation.”7
Id. at 573.
After all, the FDA has “limited resources to monitor the
11,000 drugs on the market” after the drugs receive
Id. at 578.
State tort law offers “an
additional, and important, layer of consumer protection
that complements FDA regulation” by helping to uncover
unknown drug hazards and provide incentives for drug
manufacturers to disclose safety risks promptly.
“If Congress thought state-law suits posed an
obstacle to its objectives,” the Court reasoned, “it surely
would have enacted an express pre-emption provision at some
In so finding, the Court declined to defer to the FDA’s
conclusion of preemption in the preamble to the 2006 regulation
governing the content and format of prescription drug labels.
See Requirements on Content and Format of Labeling for Human
Prescription Drug and Biological Products, 71 Fed. Reg. 3922
(2006). In the preamble to the 2006 regulation, the FDA
declared that the FDCA establishes “both a ‘floor’ and a
‘ceiling,’” such that “FDA approval of labeling . . . preempts
conflicting or contrary State law.” Id. at 3934-35. It further
stated that certain state-law actions, such as those involving
failure to warn claims, “threaten FDA’s statutorily prescribed
role as the expert Federal agency responsible for evaluating and
regulating drugs.” Id. at 3935. The Court, however, found the
preamble to be “at odds with what evidence we have of Congress’
purposes, and it reverses the FDA’s own longstanding position
without providing a reasoned explanation, including any
discussion of how state law has interfered with the FDA’s
regulation of drug labeling during decades of coexistence.”
Wyeth, 555 U.S. at 577. The Court therefore held that the FDA’s
recent pronouncement of preemption did not merit any deference.
Id. at 574-81.
point during the FDCA’s 70-year history.”
Id. at 574.
“Its silence on the issue, coupled with its certain
awareness of the prevalence of state tort litigation, is
powerful evidence that Congress did not intend FDA
oversight to be the exclusive means of ensuring drug safety
Id. at 575.
In sum, the Court in Wyeth focused exclusively on what
a drug manufacturer could do post-FDA approval to enhance
the warnings of serious risks in the labeling of its
Wyeth did not address whether a state law failure
to warn claim addressed to the NDA process was preempted.
B. PLIVA, Inc. v. Mensing
In Mensing, the Court held that state law failure to warn
claims against generic drug manufacturers were preempted by
The claim concerned the drug metoclopramide, which
the FDA first approved in 1980 under the brand name Reglan for
treatment of digestive tract problems.
Five years later,
generic manufacturers began producing metoclopramide.
began to accumulate that long-term use of the drug could cause a
severe neurological disorder in up to 29% of patients.
564 U.S. at 609.
The plaintiffs, who were prescribed the drug
in 2001 and 2002, and were administered the generic version,
developed the disorder.
Id. at 610.
The Court’s analysis focused on the different labeling
duties for brand-name and generic drug manufacturers.
Whereas a brand name drug manufacturer seeking an NDA is
responsible for the accuracy and adequacy of its label, see,
e.g., 21 U.S.C. §§ 355(b)(1), (d); Wyeth, 555 U.S. at 570-71, a
manufacturer seeking generic drug approval “is responsible for
ensuring that its warning label is the same as the brand
Mensing, 564 U.S. at 613 (citation omitted).
“sameness” requirement extends into the post-approval phase.
fact, federal law “demand[s] that generic drug labels be the
same at all times as the corresponding brand-name drug labels.”
Id. at 618 (citing 21 C.F.R. § 314.150(b)(10)).
brand name drug manufacturers may use the CBE process to
unilaterally strengthen their warning labels, generic drug
manufactures may not; they may only change their labels “to
match an updated brand-name label or to follow the FDA’s
Id. at 614.
The Court concluded that when “the
‘ordinary meaning’ of federal law blocks a private party from
independently accomplishing what state law requires, that party
has established pre-emption.”
Id. at 623.
The Court in Mensing also considered whether conflict
preemption should take into account possible actions that, in
retrospect, the FDA and brand-name manufacturer could have
Id. at 620.
As the FDA had noted in its amicus brief,
while generic drug manufacturers cannot update their labels
pursuant to the CBE regulation, they can still propose stronger
warning labels to the agency if they believe such warnings are
needed; if the FDA agrees that a label change is necessary, it
can work with a brand name drug manufacturer to create a new
label for both the brand name and generic drug.
Id. at 616.
The plaintiffs, in turn, argued that if the generic
manufacturers had asked the FDA for help in changing the
corresponding brand name label, they might eventually have been
able to accomplish under federal law what state law required.
The Court dismissed this argument as far too attenuated:
[P]re-emption analysis should not involve speculation
about ways in which federal agency and third-party
actions could potentially reconcile federal duties
with conflicting state duties. . . . [We] hold that
when a party cannot satisfy its state duties without
the Federal Government’s special permission and
assistance, which is dependent on the exercise of
judgment by a federal agency, that party cannot
independently satisfy those state duties for preemption purposes.
Id. at 623-24 (emphasis supplied).
In sum, the Court refused to
force generic manufacturers to engage in a “Mouse Trap game”
that would eventually lead to a better label on a generic drug.
Id. at 619.
C. Mutual Pharmaceutical Co., Inc. v. Bartlett
In Bartlett, the Supreme Court held that a plaintiff’s
state law design defect claim against the manufacturer of a
generic drug was preempted by federal law.
The drug at issue
In 1978, the FDA approved this nonsteroidal anti-
inflammatory pain reliever under the brand name Clinoril.
Bartlett, 133 S. Ct. at 2471.
sulindac was approved as well.
When the patent expired, generic
In a small number of
patients, use of this class of drugs can cause serious side
In 2004, the plaintiff was dispensed the generic form
and had a horrifying reaction to it.
disfigured and disabled.
She is now severely
Id. at 2472.
Relying on Mensing, the Court reasoned that a generic drug
manufacturer is prohibited by federal regulation from
independently changing the drug’s design.
As the Court
explained, “the FDCA requires a generic drug to have the same
active ingredients, route of administration, dosage form,
strength, and labeling as the brand-name drug on which it is
Id. at 2475 (citing 21 U.S.C. §§ 355(j)(2)(A)(ii)-(v)
and (8)(B); 21 C.F.R. § 320.1(c)).
If the generic manufacturer
were to change the composition of the generic drug, “the altered
chemical would be a new drug that would require its own NDA to
be marketed in interstate commerce.”
The Court in Bartlett also rejected a “stop-selling”
rationale, wherein a manufacturer can escape the impossibility
of complying with both its federal and state law duties by
choosing not to manufacturer a drug at all.
Id. at 2477-78.
the Court explained,
Our pre-emption cases presume that an actor seeking to
satisfy both his federal- and state-law obligations is
not required to cease acting altogether in order to
avoid liability. Indeed, if the option of ceasing to
act defeated a claim of impossibility, impossibility
pre-emption would be all but meaningless.
Id. at 2477 (citation omitted).
D. The Implications of the Supreme Court’s Decisions for
State Law Claims Addressed to Brand Name Drugs
In addressing failure to warn and design defect claims in
the context of generic drugs, the Court found a conflict between
state and federal law requirements that rendered compliance with
both laws impossible.
Where generic drug manufacturers did not
have the authority to unilaterally change either the drug’s
design or the label’s warning, federal law preempted the state
This same lack of authority to alter a drug’s design or a
label’s warnings exists for brand name drug manufacturers at the
time the NDA process concludes.
They have received approval
only for that formulation and that label that survive the NDA
Thereafter, however, depending on the significance of
the change to the drug’s design or the type of change in a
label, federal regulations permit manufacturers to unilaterally
alter the design and label.
Indeed, they have a duty to act.
Because manufacturers have greater access to information about
their drugs than the FDA, and the FDA has limited resources,
manufacturers retain the responsibility for the safety of their
products after they receive FDA clearance for their sale and
Among other things, they have an ongoing obligation
to monitor a drug’s risks and to report adverse responses.
Bartlett, 133 S Ct. at 2484 (Sotomayor, J., dissenting).
Supreme Court has surmised, Congress has not provided a federal
remedy for consumers harmed by unsafe or ineffective drugs
because it has “recognized that state-law remedies further
consumer protection by motivating manufacturers to produce safe
and effective drugs and to give adequate warnings.”
U.S. at 574.
Accordingly, depending on the nature of the plaintiff’s
failure to warn and design defect claim for a branded drug, the
claim may be preempted.
If the claim addresses newly acquired
information and addresses a design or labeling change that a
manufacturer may unilaterally make without FDA approval, then
there may be no preemption of the state law claim.
On the other
hand, as the Sixth Circuit recently held, a “post-approval
design defect claim is clearly preempted by federal law” where
FDA regulations prohibit a change of the type implicated by the
Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d
281, 298 (6th Cir. 2015).
Similarly, as the First Circuit has
held, a complaint alleging a labeling deficiency based on
information “plainly known to the FDA prior to approving the
label” and not information that could be corrected using the CBE
regulation, is preempted.
In re Celexa & Lexapro Mktg. & Sales
Practices Litig., 779 F.3d 34, 43 (1st Cir. 2015).
IV. California Product Liability
California recognizes three theories of product liability:
failure to warn, design defect, and manufacturing defect.
complaint asserts these three theories under both strict
liability and negligence.
A. Failure to Warn
Failure to warn arises where a manufacturer has issued no
warnings or has failed to adequately warn of dangers posed by
See Anderson v. Owens-Corning Fiberglas Corp., 53
Cal. 3d 987, 996 (1991).
Under California law, a prescription
drug manufacturer is strictly liable if it failed to “adequately
warn of a particular risk that was known or knowable in light of
the generally recognized and prevailing best scientific and
medical knowledge available at the time of manufacture and
Carlin v. Superior Court, 13 Cal. 4th 1104, 1112
(1996) (emphasis supplied).
Failure to warn based on a
negligence theory “requires a plaintiff to prove that a
manufacturer or distributor did not warn of a particular risk
for reasons which fell below the acceptable standard of care,
i.e., what a reasonably prudent manufacturer would have known
and warned about.”
Anderson, 53 Cal. 3d at 1002.
Under California law, application of the failure to warn
theory to pharmaceuticals requires the court to determine:
whether available evidence established a causal link
between an alleged side effect and a prescription
drug, whether any warning should have been given, and,
if so, whether the warning was adequate. These are
issues of fact involving, inter alia, questions
concerning the state of the art, i.e., what was known
or reasonably knowable by the application of
scientific and medical knowledge available at the time
of manufacture and distribution of the prescription
drug. They also necessarily involve questions
concerning whether the risk, in light of accepted
scientific norms, was more than merely speculative or
conjectural, or so remote and insignificant as to be
Carlin, 13 Cal. 4th at 1116.
As the California Supreme Court has acknowledged, in the
failure-to-warn context, strict liability is, to some extent, “a
hybrid of traditional strict liability and negligence doctrine”
since “the knowledge or knowability requirement for failure to
warn infuses some negligence concepts into strict liability
Id. at 1111.
The knowledge or knowability requirement
holds a drug manufacturer to the standard of “knowledge and
skill of an expert in the field,” and further obligates the
manufacturer “to keep abreast of any scientific discoveries” and
to “know the results of all such advances.”
Id. at 1113 n.3.
The manufacturer’s knowledge “must exist at the time of
“[S]ubsequently developed scientific data
[is not] controlling.”
In sum, the primary difference
between a failure to warn action premised on strict liability
and a failure to warn action sounding in negligence is that
strict liability “is not concerned with the standard of due care
or the reasonableness of a manufacturer’s conduct.”
Even where a risk is “known” or “knowable” at the time of
distribution, under California law, a manufacturer “may not be
held liable for failing to give a warning it has been expressly
precluded by the FDA from giving.”
Id. at 1115 n.4.
the manufacturer disclosed to the FDA “state-of-the-art
scientific data concerning the alleged risk” and the FDA
determined, after its review, “that the pharmaceutical
manufacturer was not permitted to warn -- e.g., because the data
was inconclusive or the risk was too speculative to justify a
warning,” then the manufacturer could not be held strictly
liable for failure to warn.
Id. at 1115.
conclusion that there was, in effect, no ‘known risk’ is
While the Carlin court refused to find federal preemption of
all common law tort remedies to failure to warn, it did
acknowledge that FDA regulations were relevant. Carlin, 13 Cal.
4th at 1114.
California also follows the learned intermediary doctrine,
which provides that “in the case of prescription drugs, the duty
to warn runs to the physician, not to the patient.”
Therefore, a manufacturer discharges its duty to warn if
it provides adequate warnings to the physician about any known
or reasonably knowable dangerous side effects, regardless of
whether the warning reaches the patient.
pharmaceutical manufacturer may not be required to provide
warning of a risk known to the medical community.”
1. The Plaintiffs’ Failure to Warn Claims Appear to Be
The defendants move to dismiss the failure to warn claims
on the grounds that they are preempted and that, in any event,
the warnings on the Eliquis label are adequate as a matter of
The complaint asserts that the label approved when Eliquis
“was first marketed” and at the time the plaintiff used the drug
did not contain adequate warnings.
The complaint identifies
fourteen different warnings that the Eliquis label or
“prescribing information” failed to give.
For example, it
asserts that the defendants failed to disclose that there is “no
drug, agent or means to reverse the anticoagulation effects of
Eliquis” in the Warnings section of the label.
asserts that the label failed to include a boxed or bolded
warning advising of serious bleeding events associated with
Finally, the complaint relies heavily on the conduct
and results of the ARISTOTLE study, which the defendants
presented to the FDA as part of their NDA submission.
To the extent that the failure to warn claims are premised
on the adequacy of the label as approved by the FDA when the
drug was first marketed in the United States, they are
See 21 U.S.C. § 355(b)(1)(F); 21 C.F.R. §
314.50(c)(2)(i) (setting out FDA labeling requirements).
FDA has explained,
The centerpiece of risk management for prescription
drugs generally is the labeling which reflects
thorough FDA review of the pertinent scientific
evidence and communicates to health care practitioners
the agency’s formal, authoritative conclusions
regarding the conditions under which the product can
be used safely and effectively. FDA carefully
controls the content of labeling for a prescription
drug, because such labeling is FDA’s principal tool
for educating health care professional about the risks
and benefits of the approved product to help ensure
safe and effective use.
Requirements of Content and Format of Labeling, 71 Fed. Reg. at
Because the complaint focuses almost exclusively on the
ARISTOTLE study, it does not appear to be premised on any
information that was “known or scientifically knowable” at the
time of manufacture and distribution that might constitute
“newly acquired information” under the CBE regulation.
discussed earlier, federal law expressly forbids a manufacturer
from changing its label after the label has received FDA
approval unless such changes are made pursuant to the CBE
The CBE regulation, in turn, requires that the
“newly acquired information” be of a “different type or greater
severity or frequency than previously included in submissions to
21 C.F.R. § 314.3(b).
Here, the complaint does not
allege that the defendants were in possession of “newly acquired
information” such that they could, pursuant to the CBE
regulation, act independently of the FDA to update the Eliquis
label with any of the fourteen categories of additional or
improved warnings listed in the complaint.
The only potential reference in the complaint to “newly
acquired information” is the following paragraph:
Before and after marketing Eliquis, Defendants became
aware of many reports of serious hemorrhaging in users
of its drugs, both as reported to the FDA and to it
directly. Yet Defendants have never disclosed to the
medical profession or patients what the incidence of
such adverse reactions are.
This threadbare allegation fails to
identify information that might constitute “newly acquired
information, including whether that information, for
example, revealed risks of a “different type” or “greater
severity or frequency” than the information revealed to the
FDA at the time of approval.
also id. § 314.70(c)(6)(iii).
See 21 C.F.R. § 314.3; see
Thus, any claim against the
defendants for failure to warn under either a strict
liability or negligence theory is dismissed, with leave to
2. The Court Declines to Rule that the Eliquis Label
Is Adequate as a Matter of Law.
The Court declines to rule on the adequacy of the
Eliquis label before the plaintiffs have an opportunity to
amend their complaint.
Because some or even all of the
failure to warn claims may be preempted, it would be
premature to address whether the complaint has adequately
pleaded a deficiency in the warnings given to physicians
through the Eliquis label.
Carlin, 13 Cal. 4th at 1116.
B. Design Defect
A design defect occurs where a product fails to perform “as
safely as an ordinary consumer would expect when used in an
intended and reasonably foreseeable manner,” or if, on balance,
“the risk of danger inherent in the design,” outweighs “the
benefits of the challenged design.”
Anderson, 53 Cal. 3d at
Under California law, a drug manufacturer may be held
liable for an alleged design defect only when the plaintiff
establishes that the manufacturer was negligent in designing the
A manufacturer may not be held strictly liable for a
See Brown v. Superior Court, 44 Cal. 3d 1049,
1061 (1988) (“[A] drug manufacturer’s liability for a
defectively designed drug should not be measured by the
standards of strict liability.”).
Because the plaintiffs’
strict liability design defect claim is barred by California
law, it is dismissed with prejudice.
The defendants move to dismiss the negligent design defect
claim on the grounds that it is preempted and inadequately pled.
The complaint alleges that Eliquis was “defective in design or
formulation in that, when it left the hands of the manufacturer
and suppliers, the foreseeable risks exceeded the benefits
associated with the design or formulation of Eliquis ... and it
was more dangerous than an ordinary consumer would expect.”
The plaintiffs’ negligent design defect claim is preempted.
It asserts that the defendants had a pre-approval duty to submit
a differently designed drug for FDA approval.
To imagine such a
pre-approval duty exists, the Court would have to speculate that
had the defendants designed Eliquis differently, the FDA would
have approved the alternate design; that Mr. Utts would have
been prescribed this alternately designed Eliquis; and that this
alternate design would not have caused Mr. Utts to suffer severe
Moreover, in order to assert preemption, the
defendants “would be required continually to prove the
counterfactual conduct of the FDA and brand-name manufacturer.”
Mensing, 564 U.S. at 623.
This is precisely the type of “Mouse
Trap” game the Supreme Court disavowed in Mensing.
See id. at
“[T]he Supremacy Clause [does not] contemplate th[is]
sort of contingent supremacy,” nor should courts “strain to find
ways to reconcile federal law with seemingly conflicting state
Id. at 622-23.
The plaintiffs’ negligent design defect claim fails for
another reason as well.
Insofar as the plaintiffs’ design
defect claim suggests that the defendants should never have sold
the FDA-approved formulation of Eliquis, such claims have been
explicitly repudiated by the Supreme Court.
In Bartlett, the
Supreme Court rejected an argument that a drug manufacturer
“should simply have pulled [the drug] from the market in order
to comply with both state and federal law.”
133 S. Ct. at 2470.
This “stop-selling” rationale is “incompatible with [the
Court’s] preemption jurisprudence,” which “presume[s] that an
actor seeking to satisfy both his federal- and state-law
obligations is not required to cease acting altogether in order
to avoid liability.”
Id. at 2477.
Leave to amend is inappropriate for this claim.
complaint’s allegations of harm due to the design defect go to
the nature of the composition of the drug.
The defendants had
no ability to alter that composition without prior approval of
See 21 C.F.R. § 314.70(b)(2)(i) (providing that
changes in the “qualitative or quantitative formulation of the
drug product, including inactive ingredients, or in the
specifications provided in the approved NDA” require
supplemental submission and approval prior to distribution of
the product made using the change).
In sum, plaintiffs’ design
defect claims are dismissed with prejudice, without leave to
C. Manufacturing Defect
A manufacturing defect is actionable under California
law when the product “comes off the assembly line in a
substandard condition: in some way it differs from the
manufacturer’s intended result or from other ostensibly
identical units of the same product line.”
Finn v. G.D.
Searle & Co., 35 Cal. 3d 691, 715 (1984) (citation
If a product meets the design specifications
applicable at the time of manufacture, there is no
In re Coordinated Latex Glove
Litig., 121 Cal. Rptr. 2d 301, 315 (Cal. Ct. App. 2002).
The defendants move to dismiss the manufacturing
defect claim as inadequately pled.
The complaint alleges
that Eliquis was “defective at the time of [its]
manufacture,” insofar as “the products differed from the
Defendants’ intended result and intended design and
specifications, and from other ostensibly identical units
of the same product line.”
The motion to dismiss is granted, with leave to amend.
The complaint fails to identify or explain how the product
ingested by Mr. Utts either deviated from the defendants’
intended result/design or from other seemingly identical
A bare allegation that the product had a
manufacturing defect is too conclusory to plead a plausible
claim or give the defendants fair notice.
V. Breach of Express and Implied Warranties
In order to plead a cause of action for breach of
express warranty under California law, the plaintiff must
allege: (1) the exact terms of the warranty; (2) the
plaintiff’s reasonable reliance thereon; and (3) a breach
of that warranty which proximately caused plaintiff’s
Williams v. Beechnut Nutrition Corp., 229 Cal.
Rptr. 605, 608 (Cal. Ct. App. 1986).
To maintain a claim
for breach of implied warranty, a plaintiff must allege (1)
that he intended to use the product for a particular
purpose; (2) that the defendant had reason to know of this
purpose; (3) that the plaintiff relied on defendant’s skill
or judgment to provide a product suitable for this purpose;
(4) that the defendant had reason to know that buyers
relied on its skill or judgment; (5) that the product was
unfit for the purpose for which it was purchased; and (6)
that it subsequently damaged the plaintiff.
Buchanan, 220 Cal. Rptr. 392, 399 (Cal. Ct. App. 1985).
the context of prescription drugs, the warnings relevant to
any breach of warranty claim are those “directed to the
physician rather than the patient.”
Carlin, 13 Cal. 4th at
Breach of warranty claims may be maintained against a
manufacturer of prescription drugs on a strict liability
basis only when the manufacturer ignores known or knowable
As the California Supreme Court has explained,
a manufacturer of prescription drugs is not strictly
liable for injuries caused by such a defect that is
neither known nor knowable at the time the drug is
distributed. To hold nevertheless that the
manufacturer’s representation, express or implied,
that a drug may be prescribed for a particular
condition amounts to a warranty that it is “fit” for
and will accomplish the purpose for which it is
prescribed, and to allow an action for personal injury
for the breach of such warranties, would obviously be
incompatible with our determination regarding the
scope of a drug manufacturer’s liability for product
Brown, 44 Cal. 3d at 1072 (citation omitted).
Finally, while privity of contract is ordinarily a
prerequisite for recovery on a theory of breach of implied
warranties of fitness and merchantability,
Baxter Healthcare Corp., 70 Cal. Rptr. 3d 566, 582 (Cal.
Ct. App. 2008), California recognizes an exception to the
privity requirement for cases involving drugs.
v. Glock, Inc., 144 Cal. Rptr. 3d 326, 353 (Cal. Ct. App.
The defendants argue that both the express and implied
warranty claims are inadequately pled.9
alleges that the defendants expressly warranted to Mr.
Utts, his physicians, and the FDA that Eliquis was, inter
alia, “safe and well accepted by users,” “safe and fit for
use of the purposes intended,” of “merchantable quality,”
and that it “did not produce any dangerous side effects in
excess of those risks associated with other forms of
Because the drug was “defective,” the
defendants breached these express warranties.
complaint does not identify the express warranties on which
this claim relies, including whether they appeared in the
labeling and package inserts for the drug, which were
approved by the FDA, whether they appeared in an
advertising campaign for the drug, or how the particular
warranty was breached.
The plaintiffs will be given an
opportunity to amend.
The complaint alleges that the defendants also
impliedly warranted to the FDA, healthcare providers, and
Because the warranty claims are so vaguely pleaded, it is
impossible to know whether they may be preempted in whole or in
consumers that the drug was of merchantable quality and
safe and fit for the ordinary purpose for which it was to
According to the complaint, because the drug was
inherently dangerous, unsafe and defective, the defendants
breached these implied warranties when they placed Eliquis
into the stream of commerce.
Given the breadth of this
allegation, the plaintiffs appear to be challenging through
their implied warranty claim the FDA’s approval of Eliquis
for sale to consumers.
Many prescription drugs are
inherently dangerous, which is why the FDCA imposes on
manufacturers the duty to submit the drug to the FDA
approval process before the drug may be prescribed by
physicians and sold by pharmacists to patients.
the express warranty claim, the plaintiffs are given leave
to amend to provide fair notice of the basis for their
VI. Fraud Causes of Action
The elements of fraud under California law are: (1)
the defendant made a false representation; (2) the
defendant knew the representation was false at the time it
was made; (3) in making the representation, the defendant
intended to deceive the plaintiff; (4) the plaintiff
justifiably relied on the representation; and (5) the
plaintiff suffered resulting damages.
Lazar v. Superior
Court, 12 Cal. 4th 631, 638 (1996).
The elements of
negligent misrepresentation mirror those of fraud except
for the second element, which for negligent
misrepresentation is that the defendant made the
representation “without reasonable ground for believing it
to be true.”
West v. JPMorgan Chase Bank, N.A., 154 Cal.
Rptr. 3d 285, 295 (Cal. Ct. App. 2013).
The elements of an action for fraudulent concealment
are: (1) the defendant concealed or suppressed a material
fact; (2) the defendant had a duty to disclose the fact to
the plaintiff; (3) the defendant intentionally concealed
the fact with the intent to defraud the plaintiff; (4) the
plaintiff was unaware of the fact and would not have acted
as he did if he had known of the concealed fact; and (5) as
a result of the concealment of the fact, the plaintiff
Knox v. Dean, 140 Cal. Rptr. 3d 569, 583
(Cal. Ct. App. 2012).
It is well established that a claim premised on a drug
manufacturer’s failure to provide data to the FDA is preempted.
See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348
In Buckman, the Supreme Court concluded that such
claims “inevitably conflict with the FDA’s responsibility to
police fraud consistently with the Administration’s judgment and
Id. at 350.
The Court reasoned that allowing
state law fraud-on-the-FDA claims would “dramatically increase
the burdens” facing potential drug applicants by causing
applicants “to fear that their disclosures to the FDA, although
deemed appropriate by the Administration, will later be judged
insufficient in state court.”
Id. at 350-51.
The Buckman Court
emphasized that “the relationship between a federal agency and
the entity it regulates is inherently federal in character.”
Id. at 347.
Accordingly, the FDA is empowered to investigate
suspected fraud, receives citizens’ reports of wrongdoing, and
may bring court actions to respond to suspected fraud.
349 (citing statutory authority).
The defendants move to dismiss these claims on the grounds
of preemption and failure to plead the claims with sufficient
The parties agree that the plaintiffs’ fraud,
negligent misrepresentation, and fraudulent concealment claims
all sound in fraud and are therefore subject to the heightened
pleading standards of Rule 9(b).
These three claims assert that the defendants
misrepresented the safety of Eliquis to the FDA, healthcare
providers, and the plaintiff.
The complaint asserts that the
defendants knew from their research and testing that they were
disseminating false information about the drug’s safety and
To the extent that these three claims are premised on the
interaction between the defendants and the FDA, then they are
preempted and dismissed with prejudice.
To the extent that
these claims seek to reach any other statements or conduct by
the defendants, they must be dismissed for failure to meet Rule
9(b)’s pleading standards.
For example, the plaintiffs fail to
identify the statements or concealed information at issue, when
such statements were made (or omitted), by whom, and through
Accordingly, the defendants’ motion to dismiss
the three fraud claims is granted, with leave to amend.
VII. Consumer Protection Law
The complaint alleges a violation of New York consumer
The defendants seek to dismiss this claim on
the ground that the plaintiffs, both California residents, lack
standing to bring a consumer protection claim under New York
The plaintiffs, in turn, request that they be granted
leave to amend this claim should the Court choose to apply
Accordingly, the defendants’ motion to dismiss
the plaintiffs’ New York consumer protection law claim is
granted, with leave to amend.
VIII. Loss of Consortium
Because at least some of Mr. Utts’ causes of action may be
repleaded, the defendants’ motion to dismiss the loss of
consortium claim is denied.
IX. Punitive Damages
The defendants seek to dismiss the plaintiffs’ demand for
California Civil Code § 3294 provides that a
plaintiff may seek exemplary damages in a non-contract claim
“where it is proven by clear and convincing evidence that the
defendant has been guilty of oppression, fraud, or malice.”
Because the plaintiffs have been given leave to amend some of
their claims, it is premature to decide whether the claim for
punitive damages should be stricken.
The defendants’ October 5 motion to dismiss is granted in
The design defect claims are dismissed with prejudice.
The plaintiffs are given leave to amend their remaining claims.
A separate scheduling order accompanies this Opinion.
New York, New York
December 23, 2016
United States District Judge
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