Sneed et al v. Bristol-Myers Squibb et al
OPINION AND ORDER.......[Regarding 16cv5668 Utts, et al., v. Bristol-Myers Squibb Co., et al.]The defendants March 10, 2017 motion to dismiss the Second Amended Complaint is granted in its entirety. The Clerk of Court shall enter judgment for the defendants. (Signed by Judge Denise L. Cote on 5/8/2017) Filed In Associated Cases: 1:17-md-02754-DLC et al.(gr)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
CHARLIE UTTS and CIARA UTTS,
BRISTOL-MYERS SQUIBB COMPANY and
For Charlie Utts and Ciara Utts:
Hunter J. Shkolnik
Napoli Shkolnik PLLC
400 Broadhollow Road
Melville, New York 11747
For Bristol-Myers Squibb Company and Pfizer Inc.:
Loren H. Brown
Cara D. Edwards
Lucas P. Przymusinski
DLA Piper LLP (US)
1251 Avenue of the Americas, 45th Floor
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 gastrointestinal bleeding from taking
Eliquis, a prescription drug manufactured, marketed, and
distributed by the defendants.
They assert that the label did
not adequately warn of the risk of excessive bleeding.
The defendants have moved to dismiss the Second Amended
Complaint (“SAC”) pursuant to Federal Rules of Civil Procedure
12(b)(6) and 9(b).
The primary issues in this motion to dismiss
are whether the plaintiffs’ state law failure to warn claims are
preempted by federal law and whether the label is adequate as a
matter of law.
For the following reasons, the defendants’
motion is granted in its entirety.
Before describing each of the SAC's claims and addressing
the legal challenges to them brought through this motion to
dismiss, it is useful to provide an overview of the analysis
Although the focus of the SAC is on an alleged
failure by the defendants to warn that use of Eliquis, which
belongs to a new class of blood thinners, runs the risk of
causing excessive bleeding and has no known antidote, those
allegations are largely abandoned in opposition to the motion to
The reason for this choice is not hard to discern.
The risk of excessive bleeding from this blood thinner and the
lack of an antidote were clearly disclosed to the Food & Drug
Administration (“FDA”) when it approved the drug, and are
prominently disclosed to medical practitioners and patients on
the FDA-approved labeling for the drug.
In opposition to this motion, therefore, the plaintiffs
emphasize two other, albeit related, issues with the drug.
plaintiffs emphasize in their brief that, despite the fact that
there is a risk of excessive bleeding and no known antidote for
the drug, the dosage recommendations for the drug are not
individually tailored and the defendants do not recommend
constant monitoring of patients using the drug.
fare no better.
When the SAC’s allegations about dosage and monitoring are
examined, those allegations fail as well.
For instance, the SAC
does not identify any specific warnings or guidance that should
have been included on the label regarding either dosage or
monitoring but were not.
The plaintiffs have not identified any
research or other clinical work that recommends another dosage
strategy than that currently described on the label, or explains
what specialized monitoring of a patient would accomplish.
These two complaints concern features of the design of the drug
that were well known to the FDA when it approved the drug.1
Faced with the fact that, as of today, there is no research
or clinical experience to suggest that any changes to the
Eliquis label’s disclosures related to a risk of excessive
The new class of drugs to which Eliquis belongs was designed to
improve on the performance of predecessor blood thinners, in
particular warfarin, in several ways, including by eliminating
the need for meticulous dose adjustment.
bleeding are warranted, the plaintiffs argue vehemently that the
motion to dismiss should be denied and that they should be
permitted to conduct discovery to try to locate evidence in the
defendants' files that might support their failure to warn
They emphasize that there is substantial ongoing
litigation over the earlier drugs in the class of drugs to which
But, the ability of other plaintiffs in other
litigation over other drugs to survive a motion to dismiss does
not relieve the plaintiffs of the requirements imposed by Rule
Accordingly, the claims in the SAC, which reduced to
their essence are attacks on the design of this drug, will be
The facts are construed in favor of the plaintiffs.
Keiler v. Harlequin Enters. Ltd., 751 F.3d 64, 68 (2d Cir.
Plaintiffs Charlie and Ciara Utts are both residents of
Mr. Utts was diagnosed with atrial fibrillation2 and
prescribed Eliquis by his doctor.
After taking Eliquis, Mr.
Utts suffered severe gastrointestinal bleeding and was
Atrial fibrillation is a common arrhythmia (i.e., abnormal
heart beat) that can cause blood clots to form in the heart.
Individuals with atrial fibrillation are at a high risk of
stroke and use blood thinners such as Eliquis to reduce the risk
hospitalized in July 2014 for approximately three weeks to
undergo blood transfusions and several rounds of dialysis.
Eliquis -- the brand name of the prescription medicine
apixaban3 -- is a blood-thinning medication used to reduce the
risk of stroke and systemic embolism in patients with
Eliquis belongs to a class of
nonvalvular atrial fibrillation.
drugs known as novel oral anticoagulants (“NOACs”).
have a known antidote or reversal agent.
It does not
medications such as warfarin,4 NOACs, including Eliquis, do not
require periodic blood testing or impose dietary restrictions on
The names “Eliquis” and “apixaban” are used interchangeably in
Warfarin, like the NOACs, is a prescription anticoagulant, or
blood thinner. Warfarin works by inhibiting vitamin K dependent
clotting factors. Patients taking warfarin must be monitored
every few weeks. The clotting test used to measure the amount
of time it takes for a patient’s blood to clot is called the
prothrombin time (“PT”) test. The results of the PT test are
used to measure the INR, or International Normalized Ratio. A
high INR indicates a high risk of uncontrollable bleeding, while
a low INR indicates a high risk of blood clots. Regular
measurement of INR levels is an essential component in the
management of patients receiving warfarin treatment. Unlike
Eliquis, warfarin has an antidote: vitamin K. Because of the
antidotal effect of vitamin K, however, patients taking warfarin
must follow a strict diet and limit their consumption of vitamin
K-rich foods. Coumadin is one of the brand names for warfarin.
FDA Approval of Eliquis
The FDA approved Eliquis for sale and marketing in the
United States in 2012.5
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 that the defendants’ agents “committed fraud
in their conduct of the ARISTOTLE study,” by, amongst other
things, “concealing side effects which occurred in test users of
While the defendants’ application was pending before the
FDA, Dr. Thomas Marcinak, an FDA employee appointed to review
Eliquis is one of four NOACs to receive FDA approval. Pradaxa
(generic name “dabigatran”), Xarelto (generic name
“rivaroxaban”), and Savaysa (generic name “edoxaban”) received
FDA approval in 2010, 2011, and 2015, respectively. This
Opinion uses the NOACs’ generic and brand names interchangeably.
The SAC also alleges the following deficiencies with the
ARISTOTLE study: (1) an unreported death; (2) loss of subjects
to follow-up; (3) major dispensing errors, such as 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 label7
contained several warnings about the risk of bleeding and the
lack of an effective antidote.
The label also offered specific
The term “label” is defined as “a display of written, printed,
or graphic matter upon the immediate container of any article.”
21 U.S.C. § 321(k). The term “labeling” means “all labels and
other written, printed, or graphic matter (1) upon any article
or any of its containers or wrappers, or (2) accompanying such
article.” Id. § 321(m). All labeling must be approved by the
FDA. Id. § 355(b)(1)(F). Specific “patient labeling” -- also
referred to as a “medication guide” -- is required where the FDA
determines that one or more of the following circumstances
exists: (1) the drug product is one for which patient labeling
could help prevent serious adverse effects; (2) the drug product
is one that has serious risks (relative to benefits) of which
patients should be made aware because information concerning the
risks could affect patients’ decision to use, or to continue to
use, the product; and (3) the drug product is important to
health and patient adherence to direction for use is crucial to
the drug’s effectiveness. 21 C.F.R. § 208.1(c). The purpose of
patient labeling is “to provide information when the FDA
determines in writing that it is necessary to patients’ safe and
effective use of drug products.” Id. § 208.1(b). Accordingly,
medication guides must be written “in English, in nontechnical,
understandable language, and shall not be promotional in tone or
content.” Id. § 208.20(a)(1). The manufacturer of a drug for
which a medication guide is required must “obtain FDA approval
of the Medication Guide before the Medication Guide may be
distributed.” Id. § 208.24(a). For purposes of this Opinion,
the term “label” and “labeling” are used interchangeably.
dosing recommendations and discussed the results of the
controversial ARISTOTLE study.
The warnings that are pertinent
to the present motion to dismiss are described here.8
Warnings about Bleeding Risks
The Eliquis label warns about the risk of serious bleeding
no less than five times.
First, in the “Highlights of
Prescribing Information” section, under the “Warnings and
Precautions” heading, the label states that “ELIQUIS can cause
serious, potentially fatal bleeding.”
In the “Full Prescribing
Information” section of the label, there is a heading entitled
“Warnings and Precautions” with a subheading entitled
This subheading provides: “ELIQUIS increases the
risk of bleeding and can cause serious, potentially fatal,
Under the “Adverse Reactions” heading, the label
states: “The most serious adverse reactions reported with
ELIQUIS were related to bleeding.”
Also under the “Adverse
Reactions” heading, the “Clinical Trials Experience” subheading
explains that the “most common reason for treatment
The SAC addresses the December 2012 Eliquis label. The label
has since been updated five times: January 2014, August 2014,
June 2015, September 2015, and July 2016. See “Eliquis
(apixaban) Tablets: Detailed View: Safety Labeling Changes
Approved by FDA Center for Drug Evaluation and Research (CDER),”
Food & Drug Admin., https://wayback.archive-it.org/7993/20161023083328/http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm384790.htm (last visited May 7, 2017). None of the parties
asserts that any of those labeling changes are relevant to the
claims in this litigation.
discontinuation in both [clinical] studies was for bleedingrelated adverse reactions.”
Under the “Overdosage” heading, the
label states that “[o]verdose of ELIQUIS increases the risk of
Finally, under the “Patient Counseling Information”
heading, the label advises physicians to inform their patients
that “it might take longer than usual for bleeding to stop, and
they may bruise or bleed more easily when treated with ELIQUIS.”
It 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 their physician.”
Warnings about Concomitant Therapy
In addition to warning generally about the risk of
bleeding, the Eliquis label also specifically warns about the
risk of bleeding when Eliquis is used in conjunction with
antiplatelet agents, such as aspirin.
The “Bleeding” subheading
Concomitant use of drugs affecting hemostasis
increases the risk of bleeding. These include aspirin
and other antiplatelet agents, other anticoagulants,
heparin, thrombolytic agents, selective serotonin
reuptake inhibitors, serotonin norepinephrine reuptake
inhibitor, and nonsteroidal anti-inflammatory drugs
Furthermore, the “Anticoagulants and Antiplatelet Agents”
subheading asserts that “[c]oadministration of antiplatelet
agents, fibrinolytics, heparin, aspirin, and chronic NSAID
use increases the risk of bleeding,” and that in the
ARISTOTLE study, for example, “concomitant use of aspirin
increased the bleeding risk on ELIQUIS from 1.8% per year
to 3.4% per year.”
Warnings about the Lack of an Effective Antidote
The Eliquis label twice warns about the fact that there is
no specific antidote to Eliquis.
First, under the “Bleeding”
subheading, the label unambiguously states: “A specific antidote
for ELIQUIS is not available,” and “[t]here 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 .
. . .”
Second, under the “Overdosage” heading, the label
states: “There is no antidote to ELIQUIS.”
In addition to warning about the lack of a specific
antidote, the label also discusses potential reversal strategies
and to what extent these strategies are supported by clinical
Because of high plasma protein binding, apixaban is
not expected to be dialyzable . . . . Protamine
sulfate and vitamin K would not be expected to affect
the anticoagulant activity of apixaban. There is no
experience with antifibrinolytic agents (tranexamic
acid, aminocaproic acid) in individuals receiving
apixaban. There is neither scientific rationale for
reversal nor experience with systemic hemostatics
(desmopressin and aprotinin) in individuals receiving
apixaban. Use of procoagulant reversal agents such as
prothrombin complex concentrate, activated prothrombin
complex concentrate, or recombinant factor VIIa may be
considered but has not been evaluated in clinical
studies. Activated oral charcoal reduces absorption
of apixaban, thereby lowering apixaban plasma
concentration . . . .
Under the heading “Dosage and Administration,” the
Eliquis label recommends dosing adjustments for older and
higher risk patients.
While the recommended dose for most
patients is 5 mg taken orally twice daily, a twice daily
dose of 2.5 mg is recommended for patients with any two of
the following characteristics: (1) 80 years or older; (2)
60 kg or less; (3) serum creatinine levels of 1.5 mg/dL or
The label further advises that when Eliquis is
coadministered with drugs that are strong dual inhibitors
of “CYP3A4” and “P-gp,” the recommended dose is 2.5 mg
No Way to Measure or Monitor the Anticoagulation
Effect of Eliquis
The “Pharmacodynamics” heading of the label advises
that “apixaban prolongs clotting tests such as prothrombin
time (PT, INR, and activated partial thromboplastin time
(aPTT),” and that “[c]hanges observed in these clotting
tests at the expected therapeutic dose, however, are small,
subject to a high degree of variability, and not useful in
monitoring the anticoagulation effect of apixaban.”
label further advises that the Rotachrom Heparin
chromogenic assay “is not recommended for assessing the
anticoagulant effect of apixaban.”
The ARISTOTLE Study
The Eliquis label discusses the ARISTOTLE study at
Some of the reported findings from the ARISTOTLE
trial include that:
ELIQUIS was superior to warfarin for the primary
endpoint of reducing the risk of stroke and systemic
embolism . . . . Superiority to warfarin was primarily
attributable to a reduction in hemorrhagic stroke and
ischemic strokes with hemorrhagic conversion compared
to warfarin. Purely ischemic strokes occurred with
similar rates on both drugs.
The label also reports that in the ARISTOTLE trial, Eliquis
showed “significantly fewer major bleeds than warfarin.”
III. Procedural History
The plaintiffs filed their complaint on July 15, 2016.
On October 5, the defendants filed a motion to dismiss the
initial complaint pursuant to Rules 12(b)(6) and 9(b).
October 13, the defendants moved the Judicial Panel on
Multidistrict Litigation (“JPML”) to transfer and
coordinate what were then 34 actions pending in 13
different districts -- including the instant action -pursuant to 28 U.S.C. § 1407.
On October 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.
The request to enter a
stay was denied on October 28.
On November 21, the case was reassigned to this Court
as related to sixteen other product liability cases filed
in this district concerning the medication Eliquis.
same day, this Court issued an Order instructing the
parties in this case and all related actions to confer and
identify one or two actions to proceed with early motion
The November 21 Order also explained that the
initiation of discovery in all actions would turn on
whether or not the Court denies the selected motions to
On December 2, the parties agreed to proceed with
a motion to dismiss in the Utts action.
On December 23, the Court issued its Opinion in Utts,
granting in part the October 5 motion to dismiss and giving
the plaintiffs leave to amend all claims except for the
design defect claim, which was entirely preempted.
Bristol-Myers Squibb Co. & Pfizer Inc., 16cv5668 (DLC),
2016 WL 7429449, at *11-12 (S.D.N.Y. Dec. 23, 2016)
An amended complaint was filed on January 20,
If the parties could not agree on a single action, the Court
permitted the plaintiffs (collectively) and the defendants to
each designate an action to proceed immediately with motion
On February 3, the defendants filed a renewed motion
to dismiss the amended complaint pursuant to Rules 12(b)(6)
On February 6, the Court issued an Order
granting the plaintiffs leave to file a second amended
complaint by February 24, noting that it would be unlikely
that the plaintiffs would have a further opportunity to
On February 7, the multidistrict litigation panel
issued an order transferring In re: Eliquis Products
Liability Litigation, 17md2754, to this Court.
The SAC was filed on February 24.
The SAC asserts ten
causes of action against the defendants: (1) manufacturing
defect; (2) failure to warn; (3) strict liability; (4)
negligence and gross negligence; (5) breach of express
warranty; (6) breach of implied warranty; (7)
fraud/fraudulent concealment; (8) negligent
misrepresentation; (9) violation of consumer protection
laws; and (10) loss of consortium.
In pleading these
claims, the plaintiffs rely on nine articles or documents
to assert what they contend is a plausible claim that the
Eliquis labeling fails to adequately warn of the risk of
The plaintiffs have since withdrawn
their manufacturing defect cause of action.
In addition to
compensatory damages, the plaintiffs seek punitive damages.
On March 10, the defendants filed a renewed motion to
dismiss the SAC.
They urge that the plaintiffs’ claims are
Analyzing each of the documents on which the
plaintiffs have relied to state a claim, the defendants
contend that the information in those documents does not
constitute newly acquired information and therefore, the
federal law of preemption bars the plaintiffs’ state law
In addition, even if the plaintiffs’ claims were
not preempted, the defendants argue that they must be
dismissed because the warnings given on the Eliquis label
were, as a matter of law, sufficient to warn of the risks
associated with excessive bleeding on which the plaintiffs’
claims are premised.
Finally, the defendants argue that
the SAC fails to meet the relevant pleading standards.
March 10 motion to dismiss became fully submitted on April
The discussion of this motion begins by describing the
federal pleading standards and identifying which state’s law
governs the Utts’ claims in the SAC.
the issue of preemption.
The Opinion then turns to
As background to the preemption
discussion, the Opinion outlines the FDA’s regulatory regime for
brand name pharmaceutical drugs.
It then applies the law of
preemption to the SAC’s state law claims, and also analyzes
whether it pleads plausible claims for relief under federal
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. N.Y. Cardiothoracic
Grp., PLLC, 570 F.3d 471, 475 (2d Cir. 2009) (citation omitted).
“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.” (citation
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).
The plausibility standard is not a “probability
requirement”; “[i]t simply calls for enough fact to raise a
reasonable expectation that discovery will reveal evidence
supporting a plaintiff’s claim for relief.”
Guar. Corp. ex rel. St. Vincent Catholic Med. Ctrs. Retirement
Plan v. Morgan Stanley Inv. Mgmt. Inc., 712 F.3d 705, 729 (2d
Cir. 2013) (citation omitted).
Nevertheless, “[w]here 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.”
556 U.S. at 678 (citation omitted).
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
To satisfy the requirements of Rule 9(b), which
applies to any pleading of fraud, 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 fraudulent
Loreley Fin. (Jersey) No. 3 Ltd. v. Wells Fargo
Sec., LLC, 797 F.3d 160, 171 (2d Cir. 2015) (citation
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).
The court may also consider
“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).
labeling is integral to the SAC.
Choice of Law
Mr. Utts is a resident of California and asserts violations
of California consumer protection laws.
Moreover, both parties
rely on California law in their briefing.
Accordingly, there is
no dispute that the SAC’s claims arise from California statutory
and common law.
FDA Approval Process
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).
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.”
The manufacturer’s NDA must demonstrate that
the drug is “safe for use under the conditions prescribed,
recommended, or suggested in the proposed labeling.”
The manufacturer’s NDA 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
Drug manufacturers must also submit proposed labeling, with
annotations, to be used with the drug.
C.F.R. § 314.50(c)(2)(i).
Id. § 355(b)(1)(F); 21
The FDA’s premarket approval of an
NDA includes the approval of the exact text in the proposed
See 21 U.S.C. § 355; 21 C.F.R. § 314.105(b).
a detailed review of proposed labeling, the FDA seeks to allow
“only information for which there is a scientific basis to be
Supplemental Applications Proposing Labeling Changes
for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg.
49603, 49604 (Aug. 22, 2008) (hereinafter, “Labeling Changes”).
The labeling must include certain categories of information
organized into predetermined headings and subheadings.
C.F.R. §§ 201.56, 201.57, and 201.80.
For example, the
“Warnings and Precautions” section of a label must describe
clinically significant adverse reactions (including
any that are potentially fatal, are serious even if
infrequent, or can be prevented or mitigated through
appropriate use of the drug), other potential safety
hazards (including those that are expected for the
pharmacological class or those resulting from
drug/drug interactions), limitations in use imposed by
them (e.g., avoiding certain concomitant therapy), and
steps that should be taken if they occur (e.g., dosage
Id. § 201.57(c)(6)(i).
The “Adverse Reactions” section requires a description of
“the overall adverse reaction profile of the drug based on the
entire safety database.”
Id. § 201.57(c)(7).
reaction” is defined as an “undesirable effect, reasonably
associated with use of a drug.”
“This definition does not
include all adverse events observed during use of a drug,” but
rather “only those adverse events for which there is some basis
to believe there is a causal relationship between the drug and
the occurrence of the adverse event.”
In addition, “any
claim comparing the drug to which the labeling applies with
other drugs in terms of frequency, severity, or character of
adverse reactions must be based on adequate and well-controlled
studies . . . .”
Id. § 201.57(c)(7)(iii).
After approval, manufacturers are required to maintain
records and disclose to the FDA any adverse health consequences
reported during the prescription drug’s use.
§ 355(k)(1); 21 C.F.R. §§ 314.80(c), 314.81.
If, on the basis
of these disclosures, the FDA learns of new safety information
which it believes should be included in the labeling of the
drug, it retains the authority to require amendments to the
21 U.S.C. § 355(o)(4); Wyeth v. Levine, 555 U.S.
555, 567 (2009) (observing that the 2007 FDCA amendments for the
first time “granted the FDA statutory authority to require a
manufacturer to change its drug label based on safety
information that becomes available after a drug’s initial
Alternatively, if the FDA finds that the drug is
not “safe” when used in accordance with its labeling, or if, on
the basis of new information, the FDA finds that the labeling of
such drug is “false or misleading in any particular and was not
corrected within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of,”
the agency “shall” withdraw its approval of the drug.
In addition, the FDA “shall” deem a drug “misbranded”
if “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.”
Id. § 352(j).
Notwithstanding the FDA’s post-approval oversight and
regulation, “manufacturers, not the FDA, bear primary
responsibility for their drug labeling at all times.”
555 U.S. at 579; see also 21 U.S.C. § 355(o)(4)(I) (providing a
rule of construction clarifying that the 2007 amendments to the
FDCA “shall not be construed to affect the responsibility of the
responsible person or the holder of the approved application . .
. to maintain its label in accordance with existing
Thus, the manufacturer 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.”
555 U.S. at 571.
There are two ways for a manufacturer to fulfill its postFDA approval labeling duties.
Generally speaking, a
manufacturer may only change a drug label after the FDA approves
a supplemental application.
See 21 C.F.R. § 314.70(b).
manufacturer may, however, make certain changes to its label
without prior agency approval through the “changes being
effected” (“CBE”) regulation.
The CBE regulation allows a
manufacturer to change its label unilaterally to “add or
strengthen a contraindication, warning, precaution, or adverse
reaction,” id. § 314.70(c)(6)(iii)(A), as soon as there is
“reasonable evidence of a causal association with a drug; a
causal relationship need not have been definitely established,”
id. § 201.57(c)(6)(i).
A manufacturer may also, pursuant to the
CBE regulation, “add or strengthen an instruction about dosage
and administration that is intended to increase the safe use of
the drug product,” id. § 314.70(c)(6)(iii)(C), or “delete false,
misleading, or unsupported indications for use or claims for
effectiveness,” id. § 314.70(c)(6)(iii)(D).
Labeling changes pursuant to the CBE regulation may only be
made on the basis of “newly acquired information.”
“Newly acquired information” is defined
[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.
Labeling Changes, 73
Fed. Reg. at 49606.
The FDA has recognized that “[e]xaggeration of risk,
or inclusion of speculative or hypothetical risks, could
discourage appropriate use of a beneficial drug . . . or
decrease the usefulness and accessibility of important
information by diluting or obscuring it.”
Applications Proposing Labeling Changes for Approved Drugs,
Biologics, and Medical Devices, 73 Fed. Reg. 2848, 2851
(Jan. 16, 2008).
Indeed, “labeling that includes
theoretical hazards not well-grounded in scientific
evidence can cause meaningful risk information to lose its
For this reason, the CBE regulation
requires that there be sufficient evidence of a causal
association between the drug and the information sought to
Id.; see also 21 C.F.R. § 201.57(c)(6)(i).
Moreover, the FDA retains the authority to reject labeling
changes made pursuant to the CBE regulations.
U.S. at 571.
By expressly requiring that a CBE supplement
only reflect newly acquired information and “be based on
sufficient evidence of a causal association,” the FDA
ensures “that scientifically accurate information appears
in the approved labeling.”
Labeling Changes, 73 Fed. Reg.
III. Federal Preemption of Pharmaceutical Claims
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 notwithstanding.”
Const., art. VI, cl.2.
“A fundamental principle of the
Constitution is that Congress has the power to preempt state
Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372
State law is preempted by federal law when Congress
intends federal law to “occupy the field,” or where state law
conflicts with a federal statute.
Id. (citation omitted).
Conflict preemption exists “where it is impossible for a
private party to comply with both state and federal law and
where, under the circumstances of a particular case, the
challenged state law stands as an obstacle to the accomplishment
and execution of the full purposes and objectives of Congress.”
Id. (citation omitted).
“Impossibility pre-emption is a
Wyeth, 555 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
“[T]he historic police powers of the State
include the regulation of matters of health and safety.”
Buono v. NYSA-ILA Med. & Clinical Servs. Fund, 520 U.S. 806, 814
As the Supreme Court has explained,
[t]hroughout our history the several States have
exercised their police powers to protect the health
and safety of their citizens. Because these are
primarily, and historically, matters of local concern,
the States traditionally have had great latitude under
their police powers to legislate as to the protection
of the lives, limbs, health, comfort, and quiet of all
Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996) (citation
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.
described in more detail in Utts, the Supreme Court’s decisions
in Wyeth, 555 U.S. 555, PLIVA, Inc. v. Mensing, 564 U.S. 604
(2011), and Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S.
Ct. 2466 (2013), read holistically, indicate that federal law
preempts all pre-FDA approval failure to warn and design defect
claims for branded prescription medication.
7429449, at *6.
See Utts, 2016 WL
As Utts explains, brand name drug manufacturers
lack the authority to alter a drug’s design or a label’s
warnings at the time the NDA approval process concludes.
*9; see Labeling Changes, 73 Fed. Reg. at 49606 (“State law
claims that challenge labeling that FDA approved after being
informed of the relevant risk are preempted.” (citation
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 -- and indeed, require -manufacturers to unilaterally alter the design and label.
there may be no preemption of state product liability law where
the plaintiffs’ claims are based on newly acquired information
that, pursuant to the CBE regulation, the defendants could
unilaterally make without FDA approval.
Utts, 2016 WL 7429449,
Post-FDA approval preemption analysis proceeds in two
First, the plaintiff must show that there existed
“newly acquired information” such that the defendants could
unilaterally change the label pursuant to the CBE regulation
without FDA approval.
But, the mere availability of a CBE label
amendment does not necessarily defeat a manufacturer’s
Because the FDA “retains the authority to
reject labeling changes,” a manufacturer may still -- even after
the plaintiff has identified “newly acquired information” -establish an impossibility preemption defense through “clear
evidence that the FDA would not have approved a change” to the
Wyeth, 555 U.S. at 571; see also In re: Fosamax
(Alendronate Sodium) Prods. Liab. Litig., 852 F.3d 268, 283-84
(3d Cir. 2017).
In sum, if the plaintiff can point to the
existence of “newly acquired information” to support a labeling
change under the CBE regulation, the burden then shifts to the
manufacturer to show by “clear evidence” that the FDA would not
have approved the labeling change made on the basis of this
newly acquired information.
California Product Liability: Failure to Warn
California recognizes three theories of product liability:
failure to warn, design defect, and manufacturing defect.
SAC asserts only a failure to warn theory of product liability.10
Its failure to warn claim is at the heart of the SAC and the
principal focus of the parties’ briefing on the motion to
Failure to warn arises when 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
Although the plaintiffs alleged a manufacturing defect claim
in the SAC, they withdrew this cause of action in their
memorandum of law in opposition to this motion. The plaintiffs
have also abandoned any design defect cause of action in
accordance with this Court’s ruling in Utts. See Utts, 2016 WL
7429449, at *11-12 (finding all design defect claims preempted
and dismissing the plaintiffs’ design defect cause of action
without leave to amend).
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 added).
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
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 1111-12.
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 distribution.”
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
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.”
The Plaintiffs’ Failure to Warn Claims Are Preempted.
The defendants first assert that the plaintiffs’ California
failure to warn claims are preempted by federal law because the
information on which the SAC relies to plead its claims is not
“newly acquired information,” as that term is defined under the
The “newly acquired information,” which is
information that was not submitted to the FDA prior to the FDA’s
approval of the drug and its label, must reveal risks of a
“different type or greater severity or frequency than previously
included in submissions to [the] FDA.”
21 C.F.R. § 314.3(b).
The SAC identifies 34 warnings that the defendants
allegedly failed to provide in the Eliquis label.
to this motion, the plaintiffs largely abandon the failure to
warn claims directed toward the risk of excessive bleeding and
the lack of an effective reversal agent.
They instead focus on
three categories of warnings: (1) monitoring; (2) advice
regarding bleeding reversal strategies; and (3) dosage
The SAC relies exclusively on nine reports, studies, and
articles as the bases for its assertion that the Eliquis
labeling was inadequate in failing to give these warnings.
of these documents are appended as exhibits to the SAC.
information contained in this literature does not constitute
“newly acquired information” under the FDA’s CBE regulation.
Accordingly, the plaintiffs’ claims are preempted because
federal law would not have permitted the defendants to make any
change to the Eliquis label.
The SAC and the plaintiffs in their brief in opposition to
this motion give the greatest emphasis to a single report, and
it is to that report that this Opinion turns first.
remainder of the nine documents or reports are given relatively
limited weight in the SAC and in the plaintiffs’ brief, and will
be addressed thereafter.
For five of these reports, the
plaintiffs do not actually contend either in the SAC or in
opposition to this motion that they contain newly acquired
Those five are discussed last.
Allegation of Newly Acquired Information
The Institute for Safe Medical Practices
QuarterWatch Report (the “ISMP Report”)
The plaintiffs rely heavily on four statements in the
ISMP Report to support their claim that the defendants have
not fully disclosed the incidence of bleeding in users of
The ISMP Report, published in September 2015,
analyzed “adverse drug event” data for NOACs from the third
and fourth quarters of 2014.
Before assessing whether the
four statements constitute newly acquired information, the
function of ISMP reports will be described.
ISMP reports draw upon “adverse drug event” reports,
among other sources of information, to describe drug safety
Federal regulations require drug manufacturers to
report “[a]ny adverse event associated with the use of a
drug in humans, whether or not considered drug related” to
21 C.F.R. § 314.80(a), (c).
All reported adverse
drug events are uploaded to the FDA Adverse Event Reporting
System (“FAERS”) database.
See “Questions and Answers on
FDA’s Adverse Event Reporting System (FAERS),” U.S. Food &
Drug Admin., https://www.fda.gov/drugs/guidancecompliance-
visited May 7, 2017) (hereinafter, “FDA Website”).
Federal regulations advise that a report submitted by
a manufacturer “does not necessarily reflect a conclusion
by the [manufacturer] or FDA that the report or information
constitutes an admission that the drug caused or
contributed to an adverse effect.”
21 C.F.R. § 314.80(l).
As the FDA Website explains:
FDA does not require that a causal relationship
between a product and event be proven, and reports do
not always contain enough detail to properly evaluate
an event. Further, FDA does not receive reports for
every adverse event or medication error that occurs
with a product. Many factors can influence whether or
not an event will be reported, such as the time a
product has been marketed and publicity about an
The Supreme Court has similarly warned that “[t]he fact
that a user of a drug has suffered an adverse event,
standing alone, does not mean that the drug caused that
Matrixx Initiatives, Inc. v. Siracusano, 563 U.S.
27, 44 (2011).
In sum, “the mere existence of reports of
adverse events . . . says nothing in and of itself about
whether the drug is causing the adverse events.”
The ISMP Report acknowledges the limitations of its
analysis of adverse event report data:
“The submission of
an individual report does not in itself establish that the
suspect drug caused the event described.”
The ISMP Report
therefore recommends that its findings “be interpreted in
light of the known limitations of a reporting system that
does not collect data systemically.”
The ISMP Report
further acknowledges that “[w]hile the sheer numbers of
case reports have scientific weight, because of variation
in reporting rates, they reveal little about how frequently
the events occur in the broader patient population.”
Among the categories of pharmaceuticals it discussed,
the ISMP Report compared adverse event reports across three
NOACs -- Xarelto, Pradaxa, and Eliquis.
It found that
Eliquis “showed the strongest safety profile from several
perspectives” and “had the best adverse event safety
profile by several measures.”
Not only did Eliquis have
the fewest reports in the FAERS database -- even after
adjusting for prescription volume -- but it also had the
fewest direct reports11 to the FDA, the fewest deaths, and
the lowest percentage of deaths.
Healthcare professionals and consumers may voluntarily report
adverse drug experiences to the FDA. If a healthcare
professional or consumer instead chooses to report an adverse
drug experience to the manufacturer, the manufacturer must
report the data to the FDA. According to the ISMP Report,
direct reports to the FDA from health professionals and
consumers are “of higher quality” and “provide signals of safety
issues that are independent of manufacturer marketing and other
patient contact programs that can skew results.”
Comparison of Eliquis and Xarelto
The ISMP Report first relies upon a table comparing
NOAC pharmaceutical adverse event reports to argue that the
defendants failed to adequately warn about the bleeding
risks associated with Eliquis.
The table lists adverse
event reports for Xarelto (rivaroxaban), Pradaxa
(dabigatran), and Eliquis (apixaban) across several events,
such as death outcomes, embolic-thrombotic events, and
The ISMP Report observed that, when
the adverse event reports were examined, the difference
between Xarelto and Eliquis “in percentage of deaths and
total hemorrhage cases were small.”
It observed as well,
however, that Eliquis had the “best adverse event safety
profile by several measures,” even when adjusted for
In the SAC, the plaintiffs allege that the fact that
Eliquis and Xarelto have a comparable incidence of death
outcomes and hemorrhaging in their adverse event reports is
“critical because real-world signal data from Xarelto was
For example, the table provides that, when examining the
adverse event reports, there were 379 death outcomes for Xarelto
users (approximately 11.4%) compared to 108 death outcomes for
Eliquis users (approximately 10.7%). The table further provides
that there were 1,647 hemorrhage events (approximately 49.4%)
for Xarelto users, and 492 hemorrhage events (approximately
48.5%) for Eliquis users.
also found to have a much high[er] incidence of adverse
events than reported in the clinical studies.”13
real world performance as compared to the clinical studies
of Xarelto says nothing about how the real world
performance of Eliquis compares to the clinical data
disclosed by the defendants to the FDA.
The table and the
description from the ISMP report do not suggest -- nor do
the plaintiffs allege -- that the real-world signal data
for Eliquis shows a greater severity or frequency of
bleeding events or deaths than previously disclosed in
Eliquis’ submissions to the FDA.
21 C.F.R. § 314.3(b).
Accordingly, the information contained in this table does
not constitute newly acquired information.
Concomitant Use of Eliquis and
According to the SAC, the ISMP Report “found that
Eliquis, when used in conjunction with commonly used
platelet inhibitors [aspirin, NSAIDs, and SSRIs, among
others],” shows a “significantly increased risk of bleeding
events compared to” the clinical data from the ARISTOTLE
For this assertion, the SAC relies on a 2013 news report,
citing data “from a federal authority,” that Xarelto’s
manufacturer faced a growing number of reports of “suspected
(Brackets in original.)
This assertion is a
misreading of the ISMP Report and the Eliquis label.
In evaluating the adverse event data, the ISMP Report
found that “concomitant therapy with platelet inhibitors
increased the odds of a hemorrhage event by threefold” in
all three NOACs and in warfarin.
This “threefold” risk
estimate is not specific to Eliquis, but rather is based on
combined adverse event data from a number of anticoagulant
medications, including warfarin.
Moreover, the Eliquis label specifically warns about
the concomitant use of platelet inhibitors and Eliquis:
Concomitant use of drugs affecting hemostasis
increases the risk of bleeding. These include aspirin
and other antiplatelet agents, other anticoagulants,
heparin, thrombolytic agents, selective serotonin
reuptake inhibitors, serotonin norepinephrine reuptake
inhibitor, and nonsteroidal anti-inflammatory drugs
Section 7.3 of the Eliquis label --
entitled “Anticoagulants and Antiplatelet Agents” -further states that “[c]oadministration of antiplatelet
agents, fibrinolytics, heparin, aspirin, and chronic NSAID
use increases the risk of bleeding.”
In connection with its discussion of concomitant
therapy, the Eliquis label also cites the results from two
clinical studies: ARISTOTLE and APPRAISE-2.
ARISTOTLE study found less than a twofold increase, the
APPRAISE-2 trial found over a fourfold increase in major
bleeding, which is greater than the “threefold” ratio cited
in the ISMP Report.
Thus, even if one were to assume that
the “threefold” estimate cited in the ISMP Report
accurately represents the Eliquis-specific bleeding rate,
this would still not constitute “newly acquired
information,” as the Eliquis label already discloses a
higher risk of bleeding than that contained in the ISMP
See 21 C.F.R. § 314.3(b) (providing that newly
acquired information must reveal risk of a “greater
severity or frequency than previously included in
submissions to FDA”).
In opposition to this motion, the plaintiffs appear to
abandon their assertion that the ISMP Report contains new
information regarding the increased risk of bleeding when
Eliquis is used in combination with antiplatelet agents.
instead argue that the guidance regarding concomitant use of
antiplatelet agents is inadequate because the label “does not
advise how or when to use combination therapy with Eliquis” or
“how commonly bleeding events will occur.”14
This omission in
The plaintiffs point to the following sentence from the ISMP
Report in support of their argument that the Eliquis labeling
inadequately warns about the risks of concomitant therapy:
The prescribing information for all three [NOACs]
contains no guidance on the concomitant use of
guidance was evident to the FDA when it approved the label and
the plaintiffs have not identified any newly acquired
information from the ISMP Report that would support a label
iii. Improved Dosage Guidance
The SAC next relies on the ISMP Report to complain that the
Eliquis label does not “mention . . . potential problems because
of Eliquis’ one size fits all dosing.”
As described above,
however, Eliquis has two recommended dosing regimens -- not just
In any event, this section of the Report provides no newly
acquired information that would support a label change regarding
In its discussion of NOAC dosing regimens, the ISMP Report
found that apixaban avoided some of the pharmacological issues
that the earlier NOACs had confronted.
For example, rivaroxaban
and dabigatran were found to have “problems in basic
pharmacology that raised questions about their suitability for
simple dosing regimens without adjusting for each patient.”
contrast, apixaban “appeared to avoid the limitations observed
antiplatelet agents other than a warning that an
increased risk of bleeding was observed.
Although proffered as a failure to warn claim, this and
several other contentions in the SAC are essentially criticisms
of the design of apixaban. Design claims are preempted. Utts,
2016 WL 7429449, at *11-12.
for rivaroxaban and dabigatran,” in part because apixaban was
tested in both once- and twice-daily regimens.
This section of
the Report concludes with the following observation:
“[U]nanswered is whether apixaban safety could be further
improved with individualizing the dose for each patient, as is
done with warfarin.”
This observation does not constitute newly
acquired information, as it simply speculates whether apixaban
safety could be further improved.
Comparison with Warfarin
Finally, the SAC relies on the ISMP Report to contend that
the Eliquis label does not “accurately reflect” that treatment
with Eliquis increases the risk of a bleeding event for a
patient when compared to “the venerable warfarin blood thinner.”
The statement cited from the Report does not, however, concern a
bleeding event, and in any event does not reflect any newly
The ISMP Report compared adverse event reports for the
three NOACs against warfarin.
One of the NOACs (not Eliquis)
had a significantly worse outcome compared to warfarin when
reports regarding embolic-thrombotic events were examined.
Eliquis and another NOAC had “increased odds of embolicthrombotic events compared to warfarin, but less so.”
defendants point out in their motion, and the plaintiffs do not
dispute, embolic-thrombotic events are ischemic strokes16 and not
Nor do the plaintiffs argue that any of this
data comparing the incidence of embolic-thrombotic events for
Eliquis and warfarin constitutes newly acquired information.
sum, data on ischemic strokes could not form the basis for a CBE
label change related to bleeding risks.
British Medical Journal Study (the “BMJ
The second study on which the SAC relies is the BMJ
Study, which was published in 2016.
According to the SAC,
the BMJ Study’s finding that NOACs were “not significantly
different from warfarin” in terms of the risk of ischemic
stroke in patients with atrial fibrillation contradicts
Eliquis’ “promotional materials.”17
The plaintiffs do not
assert that there is any deficiency in this regard in the
Nor, as explained here, could they.
There are two types of strokes: ischemic strokes and
hemorrhagic strokes. Ischemic strokes are caused by blockage of
an artery, whereas hemorrhagic strokes are caused by bleeding.
There are two types of ischemic strokes: thrombotic and embolic.
In a thrombotic stroke, a blood clot forms inside one of the
brain’s arteries. Embolic strokes are caused by a blockage that
forms elsewhere in the body and travels through the bloodstream
to the brain.
The plaintiffs’ claims regarding the defendants’
promotional materials are addressed below in connection
with the SAC’s claims of fraud and violation of
California’s consumer protection laws.
The BMJ Study is an observational study comparing the
effectiveness of warfarin and NOACs in patients with nonvalvular atrial fibrillation who were “naïve to oral
anticoagulants and had no previous indication for valvular
atrial fibrillation or venous thromboembolism.”
Study found that, for ischemic stroke only, “no significant
differences were evident . . . between NOACs and warfarin.”
Otherwise, “[t]he risks for death, any bleeding, or major
bleeding were significantly lower for apixaban and
dabigatran, compared with warfarin.”
The BMJ Study
concluded that “[a]ll NOACs are generally safe and
effective alternatives to warfarin in a clinical care
The finding regarding the risk of ischemic stroke from
the BMJ Study is consistent with the data reported in the
The Eliquis labeling provides in
Superiority to warfarin was primarily attributable to
a reduction in hemorrhagic stroke and ischemic strokes
with hemorrhagic conversion compared to warfarin.
Purely ischemic strokes occurred with similar rates on
Accordingly, the findings directed
towards the risk of ischemic stroke for Eliquis users do
not constitute newly acquired information.18
Thrombosis Journal Article
In support of two related arguments, the SAC cites a
2013 article from the Thrombosis Journal entitled
“Practical Management of Patients on Apixaban: A Consensus
First, the SAC alleges that the Eliquis label has
failed to provide guidance on managing “potentially life
threatening bleeding” even though physicians are forming a
consensus about “potentially effective avenues” to stop
serious injury and death from excessive bleeding.
does not identify the particular “avenues” that it contends
should be described in the label.
Second, the SAC alleges
that, even though the Eliquis label discusses the half-life
of apixaban, “certain studies” indicate that it “is
currently unknown what level of Eliquis would be considered
safe for an elective surgery.”
An examination of this
practical guide for physicians provides no basis to assert
In opposition to this motion, the plaintiffs argue that it is
“disingenuous” to focus exclusively on ischemic stroke instead
of all strokes. But, the SAC’s allegation regarding the BMJ
Study concerns only ischemic strokes, and the BMJ Study praises
the comparative effectiveness of Eliquis in all other regards.
that there is information about Eliquis that should have
been included in the label but was not.
As the guide explains, in the “absence of robust
clinical data for emergency and peri-operative management
of patients receiving apixaban,” an expert panel of
Australian clinicians from various fields convened to
develop tips on managing bleeding and invasive procedures
in patients taking apixaban.
The consensus guide notes
generally that in clinical trials, apixaban demonstrated a
“superior reduction in stroke and systemic embolism,
compared to warfarin,” and that apixaban resulted in
“significantly less major bleeding, compared to warfarin.”
The consensus guide contains a flowchart entitled
“Considerations for the Management of Bleeding, Based on
The article observes as well that “[a]
specific antidote for apixaban is not currently available”
and that “[i]n the absence of published data regarding the
treatment of patients with active bleeding while receiving
apixaban, discontinue apixaban, apply standard supportive
treatment and other local measures.”
The plaintiffs do not allege, however, that this expert
guidance contains, or is founded upon, any newly acquired
information regarding reversal agents or the treatment of
excessive bleeding that should be included in a drug label.
Nor is there any basis to allege, based on this guide,
that the Eliquis label’s statements regarding either the
drug’s half-life or its safety in connection with elective
surgery are misleading.
The Eliquis label contains the
following warnings about discontinuation of Eliquis for
ELIQUIS should be discontinued at least 48 hours prior
to elective surgery or invasive procedures with a
moderate or high risk of unacceptable or clinically
significant bleeding. ELIQUIS should be discontinued
at least 24 hours prior to elective surgery or
invasive procedures with a low risk of bleeding or
where the bleeding would be non-critical in location
and easily controlled.
The guide agrees that the label correctly describes
the half-life for Eliquis, and nothing in it suggests that
the label’s statement regarding elective surgery is
inaccurate in any respect.
The guide notes that apixaban
“can be ceased for a shorter period of time than warfarin
before invasive procedures,” but that a “‘safe’ residual
drug level of apixaban for surgery is presently unknown,
and no test has been correlated with bleeding risk.”
agrees with the label that “[i]n general, apixaban should
be discontinued 2 to 3 days prior to elective surgery.”
The plaintiffs do not allege that this statement contains
newly acquired information about what constitutes a safe
residual drug level of apixaban in advance of surgery.
FDA News Article
In support of its argument that the Eliquis label does
not adequately warn about the lack of an effective
antidote, the SAC cites to an August 2016 news article
about the FDA’s failure to approve “an antidote for Eliquis
This article does not refer to any new
information that would have permitted the defendants to
amend the Eliquis label.
And, in their opposition to this
motion, the plaintiffs do not argue that it does.
described above, the label discloses in unambiguous terms
that no known antidote for apixaban exists.
Construing the SAC favorably, it may assert that the
FDA’s approval of an antidote to Pradaxa -- a competing
NOAC -- constitutes newly acquired information that should
have been included in the Eliquis label.19
the SAC asserts that the Eliquis labeling should mention
“this safer alternative NOAC.”
Insofar as these
allegations are directed toward a claim that Eliquis could
or should have been designed more safely -- that is, not
Unlike every other failure to warn claim, the SAC does not
cite to any articles or reports in support of this claim.
manufactured or distributed without an effective antidote - such thinly veiled design defect claims are preempted.
But even if analyzed as a failure to warn claim, this
information does not constitute “newly acquired
As described above, the label clearly warns
that there is no reversal agent for apixaban.
federal regulations do not require a manufacturer to
include information about a competitor’s product or
See 21 C.F.R. §§ 201.56, 201.57, and 201.80.
No Allegation of Newly Acquired Information
The plaintiffs do not contend that any of the five
remaining documents to which the SAC refers contains newly
acquired information regarding an undisclosed risk of
Several of these articles merely express a
desire for further investigation into NOAC dosing regimens
or reversal agents.
As a consequence, none of the reports,
studies, or publications upon which the SAC relies help the
plaintiffs’ failure to warn claims overcome the defendants’
Each of the additional pieces of
literature is described below.
Journal of American Medical Association
Internal Medicine Article (the “JAMA
The SAC cites a February 2015 JAMA Article solely for
its critique of the ARISTOTLE study.
In opposing this
motion, the plaintiffs explain that they are relying on
this article to illustrate how some manufacturers may
conceal information about clinical studies from the FDA.
But, as an examination of the JAMA Article makes clear, its
primary critique is with the lack of attention research
misconduct receives in the scientific literature.
not suggest that the FDA was unaware of problems with the
ARISTOTLE study when it approved the Eliquis label.
The JAMA Article evaluates whether, and to what
extent, peer-reviewed literature reflects FDA findings of
research misconduct in clinical trials.
The JAMA Article
identified several published clinical trials -– including
Eliquis’ ARISTOTLE trial -- in which an FDA inspection
uncovered objectionable conditions or practices at a
clinical trial site.
With respect to the ARISTOTLE trial,
the JAMA Article noted that a clinical site in China “had
apparently altered patient records,” and that “[i]f one
were to exclude the data from the patients at that site,
the claim of a statistically significant mortality benefit
Notwithstanding this “fraudulent data,” the
JAMA Article found that “when [data from] all the suspect
Chinese sites are excluded rather than just the one at
which the evidence of alleged research misconduct was
found, the mortality benefit [of Eliquis] becomes
The JAMA Article criticized
the peer-reviewed literature for consistently relying on
the full data set from the ARISTOTLE trial without
excluding data from the site where the research misconduct
FDA Signal Report
The SAC makes a brief reference to a report of an ongoing
FDA investigation into the adverse event signal between Eliquis
and a health condition known as vasculitis.20
This does not
concern an increased or undisclosed risk of bleeding, and the
plaintiffs do not contend that it does.
In November 2016, the FDA announced that it had identified
a potential signal of a “serious risk/new safety information”
for vasculitis in patients taking Eliquis, Pradaxa, Savaysa, and
Xarelto based on adverse event reports from July to September
(last visited May 7, 2017).
The FDA reported that it is
“evaluating the need for regulatory action.”
which if anything confirms that the FDA is engaged in ongoing
Vasculitis is a condition that involves inflammation in the
blood vessels. Inflammation can cause the vessel to narrow or
close off, thereby restricting or preventing blood flow through
monitoring of Eliquis and other NOACs, does not constitute
evidence that could support a labeling change regarding bleeding
risks in Eliquis users.
As the plaintiffs have clarified in
their opposition to this motion, they rely on the 2016 FDA
Signal Report “to indicate that FDA oversight of Eliquis is
Annals of Hematology Article
The SAC points to a scientific journal article to support
its proposition that it “would be beneficial” for NOACs,
including Eliquis, to have a “more tailored” dosing regimen.21
The article, published in 2015 in the Annals of Hematology, is
entitled: “How to Choose Appropriate Direct Oral Anticoagulant
for Patient with Nonvalvular Atrial Fibrillation.”
guidance on the most appropriate NOAC for individual nonvalvular atrial fibrillation patients based on clinical trial
In its brief discussion of dosing, the article states
that “dose adjustment of rivaroxaban and edoxaban was much
better explored than apixaban,” and that “this information
should be discussed with the patient while deliberating on the
In opposition to this motion, the plaintiffs contend that this
article provides a basis to allege that the defendants are in
possession of adverse information relating to the “therapeutic
dose ranges of Eliquis that is unknown to the FDA” and that they
should update their label accordingly. That is not the
allegation in the SAC and nothing in the article provides
support for this characterization of the article.
choice of a [N]OAC for someone who would require dose
The article does not purport to offer “new analyses of
previously submitted data.”
21 C.F.R. § 314.3(b).
explores the limitations of the clinical data and offers
guidance to prescribing physicians in light of these
Accordingly, it does not constitute newly acquired
The BMJ Rivaroxaban Article
Relying on an article published in The BMJ about
another NOAC -- rivaroxaban -- the SAC argues that a new
dosing regimen for Eliquis that involves regular monitoring
and individualized dosage adjustments would “maximize
benefit and minimize harm to the patient” and would “seem
to be a much safer” approach than that currently provided
for in the Eliquis label.
This argument does not
constitute newly acquired information.
The article upon which the SAC relies to make this
argument was published in February 2016 and is entitled
“Rivaroxaban: Can We Trust the Evidence?”
investigation uncovered the use of faulty INR22 measuring
The faulty INR device used in the ROCKET-AF trial was said to
deliver results that were “clinically significantly lower" than
a laboratory method. An unreliable low reading could mean that
patients in the ROCKET-AF trial had their warfarin dose
devices in rivaroxaban’s ROCKET-AF trial, which may have
caused researchers to overstate the safety of rivaroxaban
in comparison to warfarin.
As the article points out,
however, the ARISTOTLE trial for apixaban did not utilize
the faulty device from the ROCKET-AF trial.
The article also briefly alludes to problems with a
dabigatran trial in which manufacturers withheld analyses
from regulators that suggested that monitoring of
anticoagulant activity and dosage adjustment could help
prevent major bleeds.
The FDA gave its approval to both
rivaroxaban and dabigatran before it gave its approval to
The article explores the benefits of pursuing tailored
dosing in light of the rivaroxaban and dabigatran clinical
It describes a 2015 presentation from
Robert Temple, deputy director for clinical science at the
FDA’s Center for Drug Evaluation and Research, which
“suggests that the FDA believes there is a scientific
argument for measuring the blood levels of these drugs
[i.e., NOACs] and adjusting the dose.”
The article quotes
increased unnecessarily, thereby increasing the risk of
Temple as stating that “early optimization [of dosing]
seems worthwhile,” and that
[a]fter a drug is approved, it usually takes a safety
signal to prompt significant action on the part of the
FDA. It is this lack of safety signal that appears to
be hindering the FDA in their desire to pursue
tailored dosing for [N]OACs. If it turns out that the
issue with the INR device changes the safety profile
of rivaroxaban, this may constitute the safety signal
necessary for the FDA to act in this regard.
This article does not cite to any Eliquis-specific data.
Moreover, as Mr. Temple’s remarks suggest, the FDA monitors
adverse event data and it is the lack of such data that “appears
to be hindering the FDA in their desire to pursue tailored
dosing” for NOACs.
In sum, an article about rivaroxaban that
does not contain any new analyses of Eliquis clinical data or
adverse event report data does not constitute newly acquired
The plaintiffs’ opposition to this motion reveals that
they are principally relying on this article for another
They speculate that the defendants may be
withholding information from the FDA that is relevant to
The article provides no basis for
such an inference, which in any event, has not been alleged
in the SAC.
Journal of Thrombosis & Thrombolysis Article
Finally, the SAC relies on an article published in the
Journal of Thrombosis and Thrombolysis, which offers
guidance on anticoagulant reversal strategies, to support
its assertion that there is a “growing concern amongst
physicians regarding the absence of guidance for dealing
with the unstoppable bleeds of Eliquis.”
Nothing in the
article suggests that newly acquired information exists to
support a labeling change regarding reversal agents, and
the plaintiffs do not contend otherwise.
therefore, the SAC’s complaint about a lack of a reversal
agent amounts to a preempted design claim.
Published in 2014, the article -- entitled “Novel Oral
Anticoagulants: Pharmacology, Coagulation Measures, and
Considerations for Reversal” -- provides an overview of
“emerging data on reversal strategies that not only
influence laboratory coagulation measures, but potentially
the clinical manifestations of bleeding as well.”
lengthy article, there is a two-paragraph discussion of
Eliquis and reversal strategies.
It observes, for example,
that “[t]o date, there are no published data supporting
common coagulation measures as surrogate markers for
That currently available data does not provide
guidance about anticoagulant reversal strategies does not
suggest that this information -- or lack thereof -- was
unknown to the FDA when it approved Eliquis for
Indeed, as described above, the Eliquis
label warns in detail about the lack of data on reversal
Among other things, it advises that:
There is no established way to reverse the
anticoagulant effect of apixaban . . . . A specific
antidote for Eliquis is not available. Because of
high plasma protein binding, apixaban is not expected
to be dialyzable. . . .
Preemption May be Decided on a Motion to Dismiss.
The plaintiffs repeatedly argue that the issue of
preemption cannot be decided on a motion to dismiss since the
preemption inquiry is “necessarily fact-specific” and should
therefore be decided no earlier than at summary judgment.
point to the Third Circuit’s decision in In re: Fosamax, 852
F.3d 268, as support for their argument that preemption is not a
question of law that can be decided by a court.
It is well-established that preemption may be analyzed and
decided at the motion to dismiss stage.
After all, a
“determination regarding preemption is a conclusion of law.”
Drake v. Lab. Corp. of Am. Holdings, 458 F.3d 48, 56 (2d Cir.
2006); see also Mensing, 564 U.S. 604 (reversing the Fifth
Circuit’s holding that state tort claims against generic
manufacturers are not preempted -- an issue that had been
decided by the district court on a motion to dismiss, see Demahy
v. Wyeth Inc., 586 F. Supp. 2d 642 (E.D. La. 2008)).
Court of Appeals for the Second Circuit has instructed, however,
when considering a preemption argument in the context of a
motion to dismiss, “the factual allegations relevant to
preemption must be viewed in the light most favorable to the
A district court may find a claim preempted only if
the facts alleged in the complaint do not plausibly give rise to
a claim that is not preempted.”
Galper v. JP Morgan Chase Bank,
N.A., 802 F.3d 437, 444 (2d Cir. 2015).
Moreover, contrary to the plaintiffs’ assertion in
opposition to this motion, In re: Fosamax does not stand for the
proposition that preemption cannot be decided on a motion to
As explained previously, there are two stages to the
First, a plaintiff must show that newly
acquired information exists such that the manufacturer could
unilaterally change its label in accordance with the CBE
Wyeth, 555 U.S. at 569-71.
If the plaintiff can
prove the existence of newly acquired information, the
manufacturer may still establish an impossibility preemption
defense by presenting “clear evidence” that the FDA would have
exercised its authority to reject the labeling change.
It is the second stage of the preemption analysis to which
the Third Circuit’s opinion is addressed.
In re: Fosamax holds
that the Supreme Court’s use of the phrase “clear evidence” in
Wyeth was intended as a standard of proof that a defendant must
meet in order to establish an impossibility preemption defense.
As the Third Circuit explains, “[t]he term ‘clear evidence’ does
not refer directly to the type of facts that a manufacturer must
show, or to the circumstances in which preemption will be
In re: Fosamax, 852 F.3d at 285.
“specifies how difficult it will be for the manufacturer to
convince the factfinder that the FDA would have rejected a
proposed label change.”
Thus, the “manufacturer must prove
that the FDA would have rejected a warning not simply by a
preponderance of the evidence, as in most civil cases, but by
There was no dispute in In re: Fosamax that both the
manufacturer and the FDA were in possession of newly acquired
Both [the manufacturer] and the FDA have long been
aware that antiresorptive drugs like Fosamax could
theoretically increase the risk of atypical femoral
fractures. . . . Between 1995 and 2010, scores of case
studies, reports, and articles were published
documenting possible connections between long-term
bisphosphonate use and atypical femoral fractures.
Id. at 274-75.
The issue became, therefore, whether there was
clear and convincing evidence that the FDA would have rejected
the proposed amendment.
Id. at 290-91.
In sum, the plaintiffs’ failure to warn claims are
preempted because the information upon which the SAC relies to
plausibly plead these claims does not, upon examination,
demonstrate that any newly acquired information exists to
support a label change pursuant to CBE regulations.
plaintiffs repeatedly request in opposition to this motion an
opportunity to pursue discovery, they are not entitled to
discovery on preempted claims.
The motion to dismiss mechanism
exists to prevent plaintiffs from conducting fishing expeditions
to see if they can cobble together meritorious claims.
Discovery is burdensome and expensive, and the Federal Rules of
Civil Procedure do not provide for it unless the pleading can
survive a Rule 12(b)(6) motion.
Rule 12(b) is designed
specifically to “streamline litigation by dispensing with
needless discovery and factfinding.”
U.S. 319, 326-27 (1989).
Neitzke v. Williams, 490
As the Supreme Court has observed:
It is no answer to say that a claim just shy of a plausible
entitlement to relief can, if groundless, be weeded out
early in the discovery process through careful case
management, given the common lament that the success of
judicial supervision in checking discovery abuse has been
on the modest side. . . . And it is self-evident that the
problem of discovery abuse cannot be solved by careful
scrutiny of evidence at the summary judgment stage, much
less lucid instructions to juries; the threat of discovery
expense will push cost-conscious defendants to settle even
anemic cases before reaching those proceedings.
Twombly, 550 U.S. at 559 (citation omitted).
The Eliquis Label is Adequate as a Matter of Law.
Not only are the plaintiffs’ failure to warn claims
preempted, they must also be dismissed because the warnings
given on the Eliquis label were, as a matter of law, sufficient
to warn of the excessive bleeding risks which are the focus of
each of the claims brought in the SAC.
Under California law,
“[a]n adequate warning is a sufficient defense to a strict
Temple v. Velcro USA, Inc., 196 Cal. Rptr.
531, 533 (Ct. App. 1983).
If a warning is adequate, it is a
“proper disclaimer to any express or implied warranties” and
“negate[s] any negligence or willful misconduct.”
Interpretation of the adequacy of a label, “where extrinsic
evidence is unnecessary, is a question of law for the trial
court to determine.”
A written warning is adequate if it
directly warns in plain and explicit terms of the specific risk
that has caused injury to the plaintiff.
Kearl v. Lederle
Labs., 218 Cal. Rptr. 453, 467 (Ct. App. 1985).
a “warning on a drug label is ambiguous . . . the adequacy of
the warning becomes a question of fact for the jury.”
Labs., Inc. v. Superior Court, 184 Cal. Rptr. 98, 104 (Ct. App.
While the SAC recites a litany of reasons why the Eliquis
label is inadequate, almost all of them are iterations of
dangers associated with excessive bleeding while taking Eliquis.
As the plaintiffs acknowledge in opposition to this motion,
however, the Eliquis label clearly discloses that there is a
risk of excessive bleeding and that there is no known antidote
if that occurs.
The label says without any ambiguity that
apixaban “can cause serious, potentially fatal bleeding.”
opposition to this motion, therefore, the plaintiffs rely on
just three failures to warn.
In asserting that they have adequately pleaded a failure to
warn claim, the plaintiffs argue both that the label should have
advised physicians to monitor patients on Eliquis and that it
should have given more information to physicians about how to
treat patients experiencing bleeding.
They also speculate that
the defendants may be in possession of information suggesting
that there is a “safer dosing method,” and if so, that such an
improved regimen should also have been included in the label.
Before analyzing these three assertions, it is useful to
note that the analysis of the adequacy of the Eliquis label
under California law substantially overlaps with the justconcluded preemption analysis.
In search of a plausible basis
for their failure to warn claims, the plaintiffs relied on the
nine articles discussed above.
The defendants’ motion to
dismiss examines the articles in detail and argues that the SAC
has taken passages out of context and misconstrued the
observations in the articles.
As already noted, these articles
do not contain newly acquired information to allow the
plaintiffs to escape the defendants’ preemption motion.
Similarly, the defendants are correct in concluding that, to the
extent these nine articles describe risks or other pertinent
information related to excessive bleeding, those risks and that
information are prominently and unambiguously described in the
Thus, the SAC does not plead any plausible basis
for a claim that the risks pertaining to excessive bleeding are
not included on the Eliquis label and should be added to it.
response, the plaintiffs have opposed this motion by winnowing
their failure to warn claims to the three issues to which this
Opinion now turns.
The plaintiffs contend that the label should have advised
physicians to monitor patients closely for the risks associated
with excessive bleeding.23
They reason that in the absence of
better information about the frequency of excessive bleeding
In the SAC, the plaintiffs contend that the Eliquis label
should have included a boxed and bolded warning “about serious
bleeding events associated with Eliquis.” The plaintiffs
clarify in opposition to this motion that the Eliquis label is
inadequate because, unlike the Xarelto and Pradaxa labels, the
Eliquis label does not contain a black box warning advising
physicians to monitor their patients closely for signs of
neurological impairment. The inclusion of a boxed warning
requires a supplemental submission to the FDA and FDA approval.
See 21 C.F.R. § 314.70(b)(2)(v)(C); id. § 201.57(a)(4).
events, and in the absence of an antidote for Eliquis, it is
important to advise physicians to monitor patients.
This fails to state a claim under California law.
label provides, in unambiguous terms, all of the scientifically
reliable information that physicians may need to determine how
to monitor their patients.
The SAC does not plausibly allege
The risk of excessive bleeding is fully disclosed,
as is the absence of an antidote.
The half-life of the drug is
described, and advice is given about how long before elective
surgery use of Eliquis should be discontinued.
The label warns
that standard blood tests are not useful in monitoring the
anticoagulant effect of apixaban and the literature on which the
SAC relies does not suggest otherwise.24
The SAC does not point
to any passage in any of the nine articles suggesting that
physicians require or should have more information to assist
As the Eliquis label explains, “[a]s a result of FXa
inhibition, apixaban prolongs clotting tests such as prothrombin
time (PT), INR, and activated partial thromboplastin time
(aPTT). Changes observed in these clotting tests at the
expected therapeutic dose, however, are small, subject to a high
degree of variability, and not useful in monitoring the
anticoagulation effect of apixaban.” The label further provides
that the Rotachrom Heparin chromogenic assay “is not recommended
for assessing the anticoagulant effect of apixaban.” Moreover,
as the Journal of Thrombosis & Thrombolysis article upon which
the SAC relies notes, “there are no published data supporting
common coagulation measures as surrogate markers for bleeding
them in making monitoring decisions, or otherwise plead a
plausible claim regarding monitoring.
Lack of Advice Regarding Bleeding Reversal
The plaintiffs contend that the label is inadequate for
failing to advise physicians on how to treat a bleeding event.
This Opinion has already analyzed every report cited in the SAC
and found no information to suggest that there is an ambiguity
or deficiency in the label’s warnings about treatment of severe
The SAC pointed to no information from any of those
articles regarding treatment of severe bleeds that should be
added to the label to remove an ambiguity or to warn of an
The only article that addresses the
management of bleeding in any detail is the consensus guide
published in the Thrombosis Journal.
Its recommendation is to
discontinue apixaban and apply “standard supportive treatment
and other local measures.”
This does not supply a basis for a
plausible claim that the label needed to add further guidance.
Tellingly, the SAC does not identify what treatment information
should be added to the label.
Finally, in opposition to this motion the plaintiffs
speculate that the defendants may have in their possession
“adverse information relating to the therapeutic dose ranges of
Eliquis that is unknown to the FDA.”
If they do possess such
information, the plaintiffs reason, the defendants have a duty
to warn and update their labels.
As discussed above, the label outlines different dosing
regimens for individuals of certain ages, weights, and serum
None of the nine articles or sources of
information on which the SAC relies suggests that there is a
basis to believe that another, safer dosage regimen is known and
should be disclosed.
The SAC does not identify any research or
data that undermines or contradicts the dosing guidance provided
in the label.
Accordingly, the plaintiffs cannot plausibly
allege that the defendants should have adjusted the dosing
recommendations in the Eliquis label.
Needless to say, mere
speculation about information that the defendants may possess is
insufficient to plausibly plead a claim.
See Twombly, 550 U.S.
at 555 (“Factual allegations must be enough to raise a right to
relief above the speculative level . . . .”).
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 (Ct. App. 1986).
The express warranty must
constitute “an affirmation of fact or promise or a
description of the goods.”
Weinstat v. Dentsply Int’l,
Inc., 103 Cal. Rptr. 3d 614, 626 (Ct. App. 2010) (citation
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.
Keith v. Buchanan, 220 Cal. Rptr.
392, 399 (Ct. App. 1985).
California follows the learned intermediary doctrine
with respect to warnings about a prescription drug’s
Accordingly, for purposes of liability for
breach of warranty, “it is the prescribing doctor who in
reality stands in the shoes of the ordinary consumer.”
Carlin, 13 Cal. 4th at 1118 (citation omitted).
words, the warnings relevant to any breach of warranty
claim are those “directed to the physician rather than the
Carlin, 13 Cal. 4th at 1118.
Breach of warranty claims may be maintained against a
manufacturer of prescription drugs under a theory of strict
liability only when the manufacturer ignores known or
As the California Supreme Court has
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).
while privity of contract is ordinarily a prerequisite for
recovery on a theory of breach of implied warranties of
fitness and merchantability, California recognizes an
exception to the privity requirement for cases involving
See Chavez v. Glock, Inc., 144 Cal. Rptr. 3d 326,
353 (Ct. App. 2012).
The SAC alleges that the defendants made six
representations to Mr. Utts, his physician, and to the
general public through the Eliquis label.
The SAC asserts
that Eliquis “does not conform to those representations”
because its “serious” side effects include “lifethreatening and irreversible bleeding events” like the one
suffered by Mr. Utts.25
It also brings warranty claims based on two
advertising campaigns: one in the period 2013 and 2014, and
the second in 2015 and 2016.26
The SAC alleges that in the
The six representations are that: (1) Eliquis was a “safe
and effective” blood thinner without disclosing “the extent
of the risk that Eliquis could cause serious bleeding that
may be irreversible, permanently disabling, and lifethreatening”; (2) that Eliquis was “safe and effective to
use without the need for blood monitoring and dose
adjustments”; (3) that Eliquis “did not produce any
dangerous side effects in excess of those risks associated
with other forms of treatment for reducing the risk of
stroke and systemic embolism in patients with non-valvular
atrial fibrillation”; (4) that the side effects that
Eliquis produces “were accurately reflected in the warnings
and that it was accurately [sic] tested;” (5) that Eliquis
had been “fully and adequately tested for long-term use and
was, inter alia, safe to use in the treatment of atrial
fibrillation”; and (6) that Eliquis was “a safer
alternative to warfarin and other anti-coagulants.” The
SAC adds the representation that Eliquis “reduce[s] the
risk of recurrence of DVT and/or PE and for prophylaxis of
DVT for patients undergoing hip and knee replacement
surgery.” This indication was not added to the Eliquis
label until March 2014. While Mr. Utts was taking Eliquis
during this time, he does not claim to have undergone hip
or knee replacement surgery or suffered from deep vein
thrombosis or a pulmonary embolism. The plaintiffs do not
seek to preserve this allegation in their opposition to the
Only those advertisements that were published or aired prior
to July 2014 are relevant to the plaintiffs’ claims since Mr.
Utts suffered his bleeding injury on July 16, 2014.
first campaign the defendants asserted that Eliquis
“reduced the risk of stroke more effectively than
warfarin,” was safer than warfarin, and that, unlike
Coumadin, it did not require “blood levels” to be
The SAC asserts that in the second campaign the
defendants “portray” Eliquis as the “‘best’” treatment for
atrial fibrillation and as a better and safer alternative
The SAC asserts that these statements were
false because Eliquis “is not better than warfarin from a
The breach of warranty claims are preempted, largely
for the reasons already described in connection with the
SAC’s failure to warn claims.
The SAC asserts that the
Eliquis labeling did not conform to the representations
contained therein because apixaban’s serious side effects
include excessive bleeding.
But, there is no newly
acquired information about the risk of bleeding associated
with the defendants’ particular blood thinner.
which is inherent in a blood thinner, was thoroughly
disclosed in the FDA-approved labeling and the plaintiffs’
opposition to this motion does not suggest otherwise.
The warranty claims premised on Eliquis’ commercial
advertising are also preempted.
The studies establishing
the superiority of Eliquis to warfarin, at least in certain
material respects, were disclosed in the Eliquis label.
The literature on which the SAC relies to plead its claims
provides no newly acquired information to suggest that the
comparisons of the two treatments, which are recited in the
labeling and repeated in the commercial advertising, are in
any degree false or misleading.
Reduced to their essence,
the SAC’s warranty claims attack a drug manufacturer’s
right to advertise FDA-approved drugs.
For instance, the SAC alleges that the defendants
breached an implied warranty of merchantability that
Eliquis was “safe and of merchantable quality” and “fit for
the ordinary purposes for which the product was to be
used,” namely, to reduce the risk of stroke and systemic
embolism in patients with non-valvular atrial fibrillation.
The NDA approval process requires the FDA to determine
whether a drug is “safe for use under the conditions
prescribed, recommended, or suggested in the proposed
labeling” and whether 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
21 U.S.C. § 355(d).
In approving Eliquis for
manufacture and distribution, the FDA determined that
Eliquis was safe and effective for its indicated use, i.e.,
for reducing the risk of stroke and systemic embolism in
patients with nonvalvular atrial fibrillation.
the plaintiffs’ implied warranty claim challenges the FDA’s
approval of Eliquis for this indication, such claims are
Failure to State a Claim
Many of the assertions in the SAC made in support of
the warranty claims are not warranties and do not implicate
For example, there are complaints that the
defendants should have disclosed more to physicians about
the management of Eliquis patients.
Such assertions have
already been addressed in connection with the analysis of
the failure to warn claims, and need not be addressed
But, even with respect to those portions of the
warranty claims that may be said to refer to specific
representations or warranties, whether express or implied,
the SAC fails to plausibly allege a breach.
again, largely for the reasons discussed in connection with
the failure to warn claims.
One set of “warranties”
alleged in the SAC depends on the defendants’ assertions
that use of Eliquis is accompanied by a risk of excessive
But, the SAC does not assert that this
representation is false.
Another set asserts that Eliquis
is safer in several material respects than warfarin.
assertion is made in the Eliquis labeling.
the Eliquis label indicates that “Eliquis was superior to
warfarin for the primary endpoint of reducing the risk of
stroke and systemic embolism” in a trial conducted on
patients with nonvalvular atrial fibrillation.
None of the
literature on which the SAC relies provides a basis to
assert that that statement is inaccurate.
consensus guide published in the Thrombosis Journal notes
generally that apixaban demonstrated a “superior reduction
in stroke and systemic embolism, compared to warfarin,” and
that apixaban resulted in “significantly less major
bleeding, compared to warfarin.”
In sum, there is no basis
to find a breach of warranty where the warranty is premised
on studies approved by FDA and not otherwise challenged by
the secondary literature.
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.
West v. JPMorgan
Chase Bank, N.A., 154 Cal. Rptr. 3d 285, 295 (Ct. App.
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.”
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
(Ct. App. 2012).
The parties agree that the plaintiffs’ fraud,
fraudulent concealment, and negligent misrepresentation
claims all sound in fraud and are therefore subject to the
heightened pleading standards of Rule 9(b).
referred to collectively as the fraud claims.
They will be
standards for Rule 9(b) pleading are recited above.
The SAC alleges that the defendants engaged in
fraudulent concealment and misrepresentations to the FDA,
the medical community, and the public through statements in
its December 2012 and March 2014 package inserts, the March
2014 dosing guidelines27 provided to medical providers
(which repeats statements in Eliquis’ labeling), and on its
The contentions concerning the dosing guidelines
and package inserts relate to dosage regimens, monitoring,
and the lack of a reversal agent.
The identified false
statements and omissions on the website concern the
The SAC asserts that the defendants
“fraudulently submitted” data from the study to the FDA.
The negligent misrepresentation claim relies upon the
statements made in Eliquis’ commercial marketing campaign
comparing Eliquis to warfarin that are described above.28
Dosing guidelines constitute labeling. Under the FDCA,
“labeling” embraces “all labels and other written, printed, or
graphic matter (1) upon any article or any of its containers or
wrappers, or (2) accompanying such article.” 21 U.S.C.
§ 321(m). The Supreme Court has held that the first clause
“clearly embraces advertising or descriptive matter that goes
with the package in which the articles are transported.” Kordel
v. United States, 335 U.S. 345, 349-50 (1948). With respect to
the second clause, “[o]ne article or thing is accompanied by
another when it supplements or explains it . . . . No physical
attachment one to the other is necessary.” Id. Furthermore,
federal regulations define “labeling” to include brochures,
booklets, mailings, catalogues, films, sound recordings, and
literature “containing drug information supplied by the
manufacturer . . . which are disseminated by or on behalf of its
manufacturer.” 21 C.F.R. § 202.1(l)(2).
The SAC does not indicate with any precision the statements
upon which it relies for its negligent misrepresentation claim,
but in a footnote in its opposition brief the plaintiffs explain
The SAC summarizes all of these statements as
representations that Eliquis “had been tested and was found
to be safe and/or effective to reduce the risk of stroke
and systemic embolism in patients required to take bloodthinning medications.”
The plaintiffs acknowledge that any fraud claim premised on
a theory that the defendants defrauded the FDA is preempted.
See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350
As the Supreme Court explained in Buckman, “[s]tate-law
fraud-on-the-FDA claims inevitably conflict with the FDA’s
responsibility to police fraud consistently with the
Administration’s judgment and objectives.”
state law fraud-on-the-FDA claims would “cause applicants to
fear that their disclosures to the FDA, although deemed
appropriate by the Administration, will later be judged
insufficient in state court,” and would, as a result, give
applicants an incentive to submit “a deluge of information that
the Administration neither wants nor needs, resulting in
additional burdens on the FDA’s evaluation of an application.”
Id. at 351.
The plaintiffs request that the SAC’s allegations
that it relies on the statements from the Eliquis marketing
campaign that are recited elsewhere in the SAC.
regarding a fraud on the FDA be read merely as evidentiary
background to their fraud claims.
It is unnecessary to consider here whether there is any
room to allow a fraud claim to proceed when preemption bars the
parallel claims brought under other common law theories.
Desiano v. Warner-Lambert & Co., 467 F.3d 85, 95 (2d Cir. 2006)
(allowing Michigan fraud claims to proceed when premised on
“allegations of wrongdoing apart from the defendant’s purported
failure to comply with FDA disclosure requirements”).
the statements on which the fraud claim is premised depends on
statements made to and approved by the FDA.
There is no newly
acquired information that required or suggested that the
allegedly fraudulent statements should be altered to remain
truthful and non-fraudulent.
Accordingly, the fraud claims are
Failure to State a Claim
The defendants have also shown that the three fraud claims
must be dismissed for failure to state a claim.
The SAC fails
to plead with the particularity required by Rule 9(b) a
plausible claim of fraud in connection with any of the
statements it identifies.
The SAC alleges that the March 2014 dosing guidelines
contain two fraudulent statements.29
First, the guidelines
state: “[n]o dose adjustment required in patients with mild,
moderate, or severe renal impairment alone.”
According to the
plaintiffs, this statement “intentionally misled prescribing
physicians and consumers to believe that even with moderate or
severe renal impairment, Eliquis was safe, when in fact, it was
not appropriate for such patients.”30
Second, the guidelines
state that Eliquis “[d]oes not require routine monitoring using
international normalized ratio (INR) or other tests of
The SAC alleges that “given the extreme bleeding
risk in patient populations (some of which were not adequately
studied), monitoring is required for some or all patient
populations, as the EMA and FDA have been suggesting.”
These allegations are iterations of the dosage and
monitoring allegations discussed above.
The dosage guidance
provided in the dosing guidelines was approved by the FDA as
The SAC makes a third incomplete allegation: “While there is
a section [in the dosing guidelines] regarding the fact that
‘there is no established way to reverse the anticoagulant effect
of apixaban, which can be expected to persist for at least 24
hours after the last dose,’ there is no.”
The SAC does not assert that Mr. Utts suffered from any renal
impairment, and therefore, does not provide a basis to assert
that he was defrauded by this statement.
part of its review of Eliquis’ labeling.
The SAC identifies no
studies or secondary literature to suggest that the guidance was
flawed, much less that it is fraudulent.
Moreover, the SAC
identifies no support for its assertions that Eliquis is not
safe for patients with renal impairments, or that any particular
undisclosed monitoring regimen is required for patients for whom
Eliquis has been prescribed.
The allegations regarding the package inserts are more
The SAC does not identify any particular allegedly
defective language in the inserts.
Instead, the SAC first
asserts that the recommended dosage in the insert “is false”
because “the patient characteristics . . . should have been
limited to one characteristic, instead of two of the listed
Second, the SAC asserts that the defendants
“withheld information and data that without the reversal agent,
death could result.”
For the reasons recited earlier in this Opinion, the SAC
fails to plead a claim regarding dosage.
That is even more true
with respect to the fraud claims, where the SAC completely fails
to meet the Rule 9(b) particularity burden.
The reference to
patient characteristics appears to be a reference to the label’s
recommendation that the daily dosage of 5 mg twice daily be cut
in half for patients that have two of three identified
Nothing in the SAC or the documents integral
to it provide any plausible basis to assert that scientifically
reliable information might be available to support the change
requested in the SAC, that is, that the dosage be reduced when
only one of the three characteristics is present.
Nor can the SAC credibly assert that the package inserts
withheld information concerning the potentially fatal adverse
effects of Eliquis.
Rather, the label states in clear,
unambiguous terms that Eliquis “can cause serious, potentially
fatal, bleeding” and that no antidote exists.
The SAC identifies three allegedly fraudulent statements
regarding the ARISTOTLE study that appeared on the Eliquis
website: (1) “For patients with Nonvalvular Atrial Fibrillation
(NVAF), Eliquis was proven effective in 2 Phase III studies”;
(2) “ELIQUIS is the ONLY anticoagulant that demonstrated
superiority in BOTH stroke/systemic embolism and major bleeding
vs warfarin”; and (3) “Eliquis had less major bleeding than
warfarin” and that “unlike warfarin,” no routine monitoring is
The SAC explains that “[a]ll of this data was
fraudulently submitted to the FDA, and then Defendants used this
The three characteristics are: (1) the patient is 80 years or
older; (2) the patient weighs 60 kg or less; or (3) the patient
has serum creatinine levels of 1.5 mg/dL or more.
fraudulent data to misrepresent the effectiveness of Eliquis
when citing to the ARISTOTLE study in support of its claims of
the medication’s efficacy.”
The SAC and documents integral to it indicate that the FDA
approved Eliquis after examining the ARISTOTLE study and
evaluating its flaws.
Moreover, while the SAC and the secondary
literature on which the SAC relies include discussions and
critiques of the ARISTOTLE study, neither the SAC nor that
literature provides a basis to plausibly plead that any of the
website statements is fraudulent.
Conclusory assertions of
fraud are not sufficient.
Eliquis Marketing Campaign
As explained in the plaintiffs’ opposition to this motion,
the SAC’s negligent misrepresentation cause of action is
premised on comparisons between apixaban and warfarin made in
the defendants’ marketing campaigns.
These comparisons are
The SAC’s descriptions of Eliquis’ direct-to-consumer
advertisements fail to meet Rule 9(b)’s heightened pleading
The SAC merely paraphrases the assertions made in
Eliquis’ television advertisements without providing the exact
content of the statements.
Moreover, the plaintiffs do not
plausibly allege that these representations were false.
example, none of the data or studies cited in the SAC contradict
the information contained in these advertisements.
above, not a single report, study, or article cited in the SAC
disproves the defendants’ claims that: (1) Eliquis reduces the
risk of stroke more effectively than warfarin; (2) Eliquis is
safer than warfarin; and (3) Eliquis patients’ blood levels do
not need to be monitored.
VII. California Consumer Protection Claims
The plaintiffs allege that the defendants violated
California’s Unfair Competition Law (“UCL”), Cal. Bus. & Prof.
Code § 17200, et seq., California’s False Advertising Law
(“FAL”), Cal. Bus. & Prof. Code § 17500, et seq., and
California’s Consumers Legal Remedies Act (“CLRA”), Cal. Civ.
Code § 1750, et seq.
To the extent these consumer protection
claims are premised on allegations of fraudulent conduct, they
must be pleaded with particularity under Rule 9(b), Fed. R. Civ.
California’s UCL prohibits any “unlawful, unfair or
fraudulent business act or practice and unfair, deceptive,
untrue or misleading advertising.”
Cal. Bus. & Prof. Code §
Each of the three prongs of the UCL -- “unlawful,”
“unfair,” and “fraudulent” -- provides an “independent basis for
South Bay Chevrolet v. General Motors Acceptance
Corp., 85 Cal. Rptr. 2d 301, 316 (Ct. App. 1999) (citation
The UCL “‘borrows’ violations from other laws by
making them independently actionable as unfair competitive
Korea Supply Co. v. Lockheed Martin Corp., 29 Cal.
4th 1134, 1143 (2003).
For example, “any violation of the false
advertising law necessarily violates the UCL.”
Kasky v. Nike,
Inc., 27 Cal. 4th 939, 950 (2002) (citation omitted).
The FAL, in turn, “prohibits the dissemination in any
advertising media of any ‘statement’ . . . ‘which is untrue or
misleading, and which is known, or which by the exercise of
reasonable care should be known, to be untrue or misleading.’”
Hambrick v. Healthcare Partners Med. Grp., Inc., 189 Cal. Rptr.
3d 31, 54 (Ct. App. 2015) (citing Cal. Bus. & Prof. Code. §
In sum, “[f]alse advertising under the FAL constitutes
a fraudulent business practice under the UCL.”
The CLRA prohibits specified “unfair methods of competition
and unfair or deceptive acts or practices.”
Cal. Civ. Code §
Prohibited practices include: “[r]epresenting that
goods or services have . . . characteristics, ingredients, uses
[or] benefits . . . that they do not have”; “[r]epresenting that
goods . . . are of a particular standard, quality, or grade . .
. if they are of another”; and “[a]dvertising goods or services
with intent not to sell them as advertised.”
§ 1770(a)(5), (7), and (9).
Cal. Civ. Code
The list of proscribed practices in
the CLRA also encompasses the “concealment or suppression of
McAdams v. Monier, Inc., 105 Cal. Rptr. 3d
704, 711 (Ct. App. 2010).
In an action for false advertising under California’s
consumer protection laws, the plaintiff “bears the burden of
proving the defendant’s advertising claim is false or
Nat’l Council Against Health Fraud, Inc. v. King
Bio Pharm., Inc., 133 Cal. Rptr. 2d 207, 211 (Ct. App. 2003).
Because the UCL and FAL prohibit not only advertising which is
false, but also advertising which is “misleading,” it is
necessary only to show that “members of the public are likely to
Chapman v. Skype Inc., 162 Cal. Rptr. 3d 864, 871
(Ct. App. 2013) (citation omitted).
“This is determined by
considering a reasonable consumer who is neither the most
vigilant and suspicious of advertising claims nor the most
unwary and unsophisticated, but instead is the ordinary consumer
within the target population.”
Id. at 871-72 (citation
Furthermore, “likely to deceive” implies “more than a
mere possibility that the advertisement might conceivably be
misunderstood by some few consumers viewing it in an
Id. at 872 (citation omitted).
the advertisement must be such that “a significant portion of
the general consuming public or of targeted consumers, acting
reasonably in the circumstances, could be misled.”
Whether consumers are likely to be deceived
is a question of fact that can be decided on a motion to dismiss
“only if the facts alleged in the complaint, and facts
judicially noticed, compel the conclusion as a matter of law
that consumers are not likely to be deceived.”32
The SAC brings a single cause of action premised on a
violation of the three California consumer protection laws.
claim incorporates by reference the SAC’s prior allegations
regarding the defendants’ “marketing and advertising” campaign,
asserting that the defendants failed to disclose the dangerous
side effects of Eliquis and misrepresented its benefits to
physicians and consumers.
For the reasons already explained, the plaintiffs’ consumer
protection claims are preempted and fail as well to meet the
pleading standards under Rules 8(a) and 9(b), Fed. R. Civ. P.33
The SAC provides a threadbare recital of the elements of
California’s consumer protection laws, supported by mere
The parties do not address whether the learned intermediary
doctrine applies to claims brought under California’s consumer
protection laws. See Saavedra v. Eli Lilly & Co., 2:12-cv-9366SVW-MAN, 2013 WL 3148923, at *2-4 (C.D. Cal. June 13, 2013)
(finding that the learned intermediary doctrine applies to
consumer protection claims predicated on a failure to warn).
To the extent the SAC’s consumer protection claims are lack of
substantiation claims, there does not appear to be a private
right of action under California law. See King Bio, 133 Cal.
Rptr. 2d at 213 (“Private plaintiffs are not authorized to
demand substantiation for advertising claims.”).
The SAC does not allege with any
specificity the contents of the fraudulent advertisements, when
such representations were made, and why such representations
were, at the very least, misleading to a reasonable consumer.
Nor does the SAC plausibly allege that there exists certain
information or data that somehow undermines or contradicts the
information communicated through Eliquis’ advertising campaign.
Accordingly, the plaintiffs’ consumer protection claims are
dismissed since they cannot plausibly allege that the
defendants’ advertising contained false or even misleading
VIII. Strict Liability, Negligence, and Gross Negligence
The parties principally discuss strict liability and
negligence theories in the context of other claims which have
already been addressed in this Opinion.
The plaintiffs have
identified no separate reason to believe that these claims would
survive the present motion if the other claims cannot.
the plaintiffs describe precisely in what ways the defendants
negligently failed to warn of certain risks or advertised
Eliquis other than those already described.34
Because none of the plaintiffs’ claims survives the
defendants’ motion to dismiss, the plaintiffs’ claims for loss
of consortium and punitive damages are dismissed as well and
need not be addressed.
The defendants’ March 10, 2017 motion to dismiss the Second
Amended Complaint is granted in its entirety.
The Clerk of
Court shall enter judgment for the defendants.
New York, New York
May 8, 2017
United States District Judge
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