McDowell v. Eli Lilly and Company

Filing 34

OPINION re: 17 MOTION for Summary Judgment . filed by Eli Lilly and Company. Based on the facts and conclusions set forth herein, the Defendant's motion for summary judgment is granted, and judgment will entered in its favor dismissing of Plaintiff's claims. (Signed by Judge Robert W. Sweet on 11/7/2014) (kgo)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK

---------------------------------------x
JESSE MCDOWELL,

Plaintiff,
-against-

13 Civ.

3786

ELI LILLY AND COMPANY,

Defendant.

---------------------------------------x
A P P E A R A N C E S:

Attorne s for Plaintiff

POGUST & BRASLow, LLC
161 Washington Street, Suite 1520

Conshohocken, PA 19428
By: Harris L. Pogust, Esq.

-·-·------. -USDCSDNY

Attorneys for Defendant

COVINGTON & BURLING
1201 Pennsylvania Avenue, NW
Washington, DC 20004
By: Phyllis A. Jones, Esq.
Michael X. Imbroscio, Esq.
Brett c. Reynolds, Esq.

COVINGTON & BURLING
620 Eighth Avenue
New York, NY 10018
By;

Laura M. Flahive Wu, Esq.

DOCUMENT

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Sweet, D.J.

Defendant Eli Lilly and Company ("Eli Lilly" or the
"Defendant") has moved pursuant to Federal Rule of Civil
Procedure 56 for summary judgment dismissing the failure-to-warn
diversity action brought by the plaintiff Jesse McDowell
("McDowell" or the "Plaintiff").

Based upon the facts and

conclusions set forth below, the Defendant's motion is granted
and the action is dismissed.

Prior Proceedings

The Plaintiff filed his complaint on June 4, 2013
alleging that the Defendant's labelling for its anti-depression
drug Cymbalta failed to warn adequately about the risk of
withdrawal upon continuance and that the Defendant designed the
drug defectively, was negligent, breached an implied warranty,
made a negligent misrepresentation, committed fraud,

and

violated state consumer fraud laws.

Discovery proceeded and the instant motion was heard
and marked fully submitted on September 17, 2014.

1

·--··

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The Facts

The facts have been set forth in the Defendant's Rule
56.1 Statement, the Plaintiff's Response to Defendant's Rule
56.1 Statement and Statement of Facts, and Defendant's Response
to Plaintiff's Statement of Facts.

The facts are not in dispute

except as noted below.

Defendant's Rule 56.1 Statement

On August 3, 2004, the United States Food and Drug
Administration ("FDA") approved Cymbal ta (duloxetine), a
serotonin norepinephrine reuptake inhibitor ("SNRI"), for the
treatment of major depressive disorder.

At the same time, the

FDA approved the contents of the U.S. Physician Package Insert,
or label, for Cymbalta.

The Cymbalta Physician Package Insert in effect in
September 2008 cited the risk of potential discontinuationemergent adverse events in three sections of the label:
Highlights of Prescribing Information, Dosage and
Administration, and Warnings and Precautions.

2

The Cymbalta Physician Package Insert included the
following language on the risk of potential discontinuation
symptoms in the Highlights of Prescribing Information section:

HIGHLIGHTS OF PRESCRIBING INFORMATION

DOSAGE AND ADMINISTRATION

Discontinuing Cymbalta: A gradual dose reduction
is recommended.
WARNINGS AND PRECAUTIONS

Discontinuation: May result in symptoms,
including dizziness, nausea, headache, fatigue,
paresthesia, vomiting, irritability, nightmares,
insomnia, diarrhea, anxiety, hyperhidrosis, and
vertigo (5.6).

The Cymbalta Physician Package Insert included the
following language on the risk of potential discontinuation
symptoms in the Dosage and Administration section:

2 DOSAGE AND ADMINISTRATION

2.4 Discontinuing Cymbalta

Symptoms associated with discontinuation of
Cymbalta and other SSRis and SNRis have been
reported. A gradual reduction in the dose rather
3

than abrupt cessation is recommended whenever
possible [see Warnings and Precautions (5.6)]

The Cymbalta Physician Package Insert included the
following language in the Warnings and Precautions section:

5 WARNINGS AND PRECAUTIONS
5.1 Clinical Worsening and Suicide Risk

All patients being treated with antidepressants
for any indication should be monitored
appropriately and observed closely for clinical
worsening, suicidality, and unusual changes in
behavior, especially during the initial few
months of a course of drug therapy, or at times
of dose changes, either increases or decreases.

If the decision has been made to discontinue
treatment, medication should be tapered, as
rapidly as is feasible, but with recognition that
discontinuation can be associated with certain
symptoms [see Dosage and Administration (2.4) and
Warnings and Precautions (5.6) for descriptions
of the risks of discontinuation of Cymbalta].

The Cymbalta Physician Package Insert included the
following language in the Warnings and Precautions section:

5.6 Discontinuation of Treatment with Cymbalta
Discontinuation symptoms have been systematically
evaluated in patients taking duloxetine.
Following abrupt or tapered discontinuation in
placebo-controlled clinical trials, the following
symptoms occurred at a rate greater than or equal

4

to 1% and at a significantly higher rate in
duloxetine-treated patients compared to those
discontinuing from placebo: dizziness, nausea,
headache, fatigue, paresthesia, vomiting,
irritability, nightmares, insomnia, diarrhea,
anxiety, hyperhidrosis and vertigo.

During marketing of other SSRis and SNRis
(serotonin and norepinephrine reuptake
inhibitors), there have been spontaneous reports
of adverse events occurring upon discontinuation
of these drugs, particularly when abrupt,
including the following: dysphoric mood,
irritability, agitation, dizziness, sensory
disturbances (e.g., paresthesias such as electric
shock sensations), anxiety, confusion, headache,
lethargy, emotional instability, insomnia,
hypomania, tinnitus, and seizures. Although these
events are generally self-limiting, some have
been reported to be severe. Patients should be
monitored for these symptoms when discontinuing
treatment with Cymbalta. A gradual reduction in
the dose rather than abrupt cessation is
recommended whenever possible. If intolerable
symptoms occur following a decrease in the dose
or upon discontinuation of treatment, then
resuming the previously prescribed dose may be
considered. Subsequently, the physician may
continue decreasing the dose but at a more
gradual rate.

According to the Plaintiff, the following language
contained in Section 5.6 of the Package Insert is deliberately
misleading and inaccurate: "Following abrupt or tapered
discontinuation in placebo-controlled clinic trials, the
following symptoms occurred at a rate greater than or equal to
1% and at a significantly higher rate in duloxetine-treated
patients compared to those discontinuing from placebo .
5

"

and Defendant has been aware since 2005 at the very latest that
approximately 44% of patients who abruptly discontinued Cymbalta
after having used the medication for 9 weeks or less experienced
withdrawal symptoms, as well as 50% of patients who had used the
medication for "longer term" trials.

The American Psychiatry Association's Practice
Guidelines For the Treatment of Patients With Major Depressive
Disorder ("APA Guidelines")

state that "[a]s with the

S[elective] S[erotonin] R[euptake]

I[nhibitors]s, abrupt

discontinuation of SNRis should be avoided whenever possible."
AMERICAN PSYCHIATRIC ASSOCIATION, PRACTICE GUIDELINE FOR THE TREATMENT OF
PATIENTS WITH MAJOR DEPRESSIVE DISORDER 40 (2010), available at
http://psychiatryonline.org/pb/assets/raw/sitewide/practice guid
elines/guidelines/mdd.pdf.

According to the Plaintiff, it does

not appear that these "guidelines" are tailored to Cymbalta or
its specific risks and these guidelines were approved in May
2010 and published in October 2010 while Plaintiff began his
Cymbalta treatment in September 2009.

The APA Guidelines further recommend that "[w]hen
pharmacotherapy is being discontinued, it is best to taper the
medication over the course of at least several weeks," and that

6

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discontinuation symptoms may occur.

PRACTICE GUIDELINE FOR THE

TREATMENT OF PATIENTS WITH MAJOR DEPRESSIVE DISORDER 20.

In 2005, an article entitled "Symptoms following
abrupt discontinuation of duloxetine treatment in patients with
major depressive disorder" was published in the Journal of
Affective Disorders

("2005 JAD Article").

David G. Perahia et

al., Symptoms Following Abrupt Discontinuation of Duloxetine
Treatment In Patients with Major Depressive Disorder, 89 J.
AFFECTIVE DISORDERS 207

(2005).

Two of the named authors David G.

Perahia, and Durisala Desaiah, were employees of the Lilly
Research Centre and Lilly Research Laboratories, respectively,
at the time of the publication of the 2005 JAD Article.

According to the Plaintiff, there were three authors
who contributed to the article who were Lilly employees: Daniel
Kajdasz is also affiliated with the Lilly Research Laboratories.
Further, the fourth author had been "paid by Eli Lilly" for
lecturing and consultancy work.

Additionally, the article was

never circulated to Nurse Practitioner Joan Caruana ("Caruana")
nor other prescribing practitioners, and the Defendant has
produced no evidence that in 2008 the information contained in

7

the 2005 article appeared anywhere other than the Journal of
Affective Disorders.

The 2005 JAD Article reported data arising from nine
clinical trials assessing the efficacy and safety of Cymbalta in
the treatment of major depressive disorder.

All of the studies

in the article "were funded, designed and conducted by Eli Lilly
and Company."

The 2005 JAD Article noted that discontinuation

symptoms are "common following antidepressant treatment."
Perahia et al., supra, at 207.

The 2005 JAD Article reported that in the short-term
placebo-controlled study "[s]ignificantly more duloxetinetreated patients (44.3%)

reported at least 1 DEAE than placebo-

treated patients (22.9%), with dizziness being the most common
symptom."

Perahia et al., supra, at 208.

The 2005 JAD Article reported that "[o]f the 510
events reported, 203 (39.8%) were mild, 258
moderate and 49 (9.6%) were severe."
208-09.

(50.6%) were

Perahia et al., supra, at

According to the Plaintiff, the "510 events reported"

only account for the events reported in six of the nine studies

8

and therefore do not represent the total number of events
reported for the entirety of the studies.

The 2005 JAD Article reported that in the long-term
placebo-controlled study "[s]ignificantly more duloxetinetreated patients reported at least one discontinuation-emergent
adverse event ("DEAE")

(9.1%) than did placebo-treated patients

(2.0%) with dizziness being the most common symptoms."
et al., supra, at 210.

Perahia

The 2005 JAD Article reported that "[o]f

the 34 DEAEs reported, 24

(70.6%) were mild,

moderate, and 1 (2.9%) was severe."

Id.

9 (26.5%) were

According to the

Plaintiff, it is significant to point out that the "34 DEAEs"
referenced only reflect the reportable DEAEs for the two longterm trials.

The 2005 JAD Article reported that in the uncontrolled
52-week open-label study, "half of the patients reported at
least one DEAE with dizziness being the most common symptom."
Id.

The 2005 JAD Article reported that "[a]mong the 281
patients reporting at least one DEAE, there were a total of 793
DEAEs reported of which 290 (36.6%) were reported as being of

9

mild severity, 367
Id.

(46.3%) moderate, and 136 (17.2%) severe."

According to the Plaintiff, the figures of "281" patients

and "793 DEAEs" are only representative of the findings of one
of the nine studies: the 52-week open-label study.

The Plaintiff began experiencing symptoms of
depression and anxiety at the age of 18.

At that time, he

experienced a "lack of motivation or desire to really do
anything" or "participate in any activities at all." (Pl.'s Dep.
106:21-107:25.)

As a consequence of his depression, the

Plaintiff would experience periods of one to two months where he
"would feel really down."

(Id. at 108:17-109:5.)

The Plaintiff also experienced periods in which he had
trouble with his sleep, including both "times that I really
slept too much, and then there were times that it was -- that I
just didn't get a lot of sleep at all."

(Id. at 109:23-110:20.)

The Plaintiff denies that sleep issues began at age 18.

The Plaintiff also suffered migraines, which he
reported in his October 30, 2008 visit to neurologist Dr. Josh
Torgovnick.

(Id. at 113:22-22; 171:5-7.)

10

Handwritten notes drafted by the Plaintiff prior to
his first visit with Caruana in September 2008 indicate that he
had previously taken Remeron, Zoloft, Lexapro, Wellbutrin,
Effexor, and Prozac, alone and in combination, in an effort to
manage his depression.

(Caruana Med. R. 4.)

After treatment

with those medications, the Plaintiff "had not yet been able to
get [his] depression under control."

(Pl.'s Dep. 140:15-18.)

The Plaintiff's handwritten notes of the
antidepressants he had taken prior to commencing Cymbalta
therapy indicate that he experienced side effects with all of
those therapies, including insomnia, "feeling over-medicated,"
"tranquilized feeling[s]," "no energy," a "tight heavy feeling
in [the] head," feeling "physically tired," feeling "down" even
after increased dosages, and "feelings of paranoia."

(Caruana

Med. R. 4.)

Caruana first prescribed Cymbalta to the Plaintiff in
September 2008.

(Caruana Dep. 11:13-15; 18:22-24.)

Because the Plaintiff had tried various medications in
the past, Caruana agreed that she had been "looking for perhaps
a different option from something he had used before

11

unsuccessfully," and that it was her "best medical judgment at
the time that Cymbalta was the best treatment to consider that
given moment."

(Id. at 145:8-25.)

As a consequence of her experience as a nurse
practitioner treating patients with affective disorders, Caruana
understood that when discontinuing an antidepressant "[t]here
are symptoms that are going to occur if you .
abruptly."

. discontinue

(Id. at 33:18-25.)

Caruana further indicated that she understood that
"most patients who stop abruptly are going to get .
of stopping abruptly," because "[p]atients report[ed]
[her]."

(Id. at 33:4-17.)

symptoms
it to

According to the Plaintiff,

Caruana's testimony is unclear as to whether she was referring
to antidepressants in general or Cymbalta.

Caruana knew from her clinical practice that a gradual
dose reduction was the recommended course of action for
discontinuing Cymbalta treatment.

(See id. at 38:2-23.)

Caruana was generally aware of the potential discontinuation
symptoms described in the Cymbalta Physician Package Insert,
including dizziness, nausea, headache, fatigue, paresthesia,

12

vomiting, irritability, nightmares, insomnia, diarrhea, anxiety,
hyperhidrosis, and vertigo.

(See id. at 39:13-40:2.)

According

to the Plaintiff, this is a presumption about Caruana's general
testimony.

Caruana knew that paresthesias occur "very frequentlyu
upon discontinuation of antidepressants from her clinical
experience.

(See id. at 40:22-24.)

From her own personal experience, Caruana understood
that at least half of her patients who discontinued an SNRI or
SSRI abruptly experienced some type of discontinuation symptom.
(See id. at 41:5-23; 57:16-58:11.)

According to the Plaintiff,

her testimony was unclear as to whether she was ref erring to
Effexor or to SSRis and SNRis in general.

In Caruana's clinical experience, she had seen that
"many peopleu experience discontinuation symptoms.

(See id. at

58:10-11.)

With respect to discontinuation of antidepressants,
Caruana agreed that "you'd want to wean or taper someone off a
medicine to minimize the chance of those symptoms.u

13

(See id. at

34:2-8.)

Caruana did not understand the Cymbalta label's

reference to discontinuation symptoms occurring "at a rate
greater than or equal to 1%" to mean that there was only a 1%
chance of the listed symptoms occurring.

(See id. at 47:14-18.)

Had Cymbalta's Physician Package Insert stated that
discontinuation events occurred in at least one patient in the
Cymbalta clinical trials 44.3% of the time while they occur in
placebo discontinuation 22.9% of the time, it would not have
impacted Caruana's decision to prescribe Cymbalta because "in
actual practice .
those problems."

[she had]

seen that many people .

(Id. at 58:08-11.)

have

Plaintiff denies this

statement citing later testimony from Caruana that had she been
aware in 2008 of the results from the clinical trials that 44%
of patients on Cymbalta for 9 weeks and 50% percent of patients
on longer trials were experiencing withdrawal symptoms, she
would have opted to "choose another drug" for the Plaintiff.
(Id. at 137:18-138:16.)

Caruana continued to prescribe Cymbalta to the
Plaintiff during the period in which he was under her care, from
September 2008 to April 2009.
26:11; 28:12-29:5.)

(See - - at 22:20-25:10; 25:19id.
--

After initiating Cymbalta treatment in

14

September 2008, the Plaintiff continued to fill prescriptions
for Cymbalta until May 2012.

(Thriftway Pharmacy R. 6.)

The Plaintiff stopped taking Cymbalta in or around
June 2012.

(See id.; see also Pl.'s Dep. 162:7-11.)

Upon discontinuing Cymbalta, the Plaintiff claims that
he experienced "brain zaps," "suicidal thoughts," "insomnia,"
"headaches," and "dizziness" (Pl.'s Resp. to Def.'s Interr. No.
5) and in addition the Plaintiff's "brain zaps" ended by the
spring of 2013.

(See Pl.'s Dep. 165:25-166:14.)

The Plaintiff's dizziness ended within four months of
discontinuing Cymbalta.

(See id. at 171:12-14.)

The Plaintiff's headaches existed "over a week" after
discontinuing Cymbalta.

(See id. at 170:22-24.)

The Plaintiff no longer suffers any of the
discontinuation symptoms he has alleged.

(See id. at 178:7-10.)

According to the Plaintiff, while most of the withdrawal
symptoms he experienced post-discontinuation have since

15

subsided, he continues to live with the memory and fear of a
(See id. at 184:21-185:7.)

return of his suicidal thoughts.

Plaintiff's Statement of Facts

In the early 2000s, Lilly conducted clinical trials
for their new drug, Cymbalta, to analyze the occurrence rate of
withdrawal symptoms following discontinuation of the medication.
The studies revealed that 44% of patients discontinuing after
eight to nine weeks and 50% of longer-term trial patients
reported withdrawal symptoms similar to those that Plaintiff
would eventually come to suffer.

(See Perahia et al., supra;

see also INSTITUTE FOR SAFE MEDICATION PRACTICES'

WHY

REPORTS OF SERIOUS

ADVERSE EVENTS CONTINUE TO GROW ( 2012) ' available at
www.ismp.org/quarterwatch/pdfs/2012Ql.pdf.

The Defendant denies

this statement in part stating, as described in the 2005 JAD
Article, Eli Lilly funded, designed, and conducted nine multicenter clinical trials to examine the efficacy and safety of
Cymbalta in treating major depressive disorder.

See Perahia et

al., supra.

The description of the Plaintiff's alleged symptoms as
similar to those experienced by trial participants is without

16

citation to specific admissible evidence and is therefore
denied.

These results were published in the 2005 JAD Article.
See Perahia et al., supra.

The results were not released nor

published elsewhere as of September 2008, the time at which
Plaintiff was initially prescribed Cymbalta by his treating
nurse practitioner, Caruana.

The Defendant denies this

statement in part as without citation to specific admissible
evidence.

Defendant further notes that these data were

disseminated by and cited to in other sources, including
government publications and internet fora.

See' e.g. ' GARTLEHENER

ET AL., U.S. DEP'T OF HEALTH AND HUMAN SERVS. AGENCY FOR HEALTHCARE RESEARCH
AND QUALITY, COMPARATIVE EFFECTIVENESS OF SECOND-GENERATION ANTIDEPRESSANTS IN
THE PHARMACOLOGIC TREATMENT OF ADULT DEPRESSION, 7 COMPARATIVE EFFECTIVENESS
REVIEW 1, 99, APP'x D-193 (Jan. 2007)

(summarizing results of the

2005 JAD Article and analyzing its quality), available at
http://www.ncbi.nlm.nih.gov/books/NBK43023/pdf/TOC.pdf.

In

addition, as required by regulation, Eli Lilly also provided the
study to the FDA.

See

u. s. FOOD

&

DRUG ADMIN.' GUIDANCE FOR INDUSTRY

E2C CLINICAL SAFETY DATA MANAGEMENT: PERIODIC SAFETY UPDATE REPORTS FOR
MARKETED DRUGS 15-16 (1996)' available at

17

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryI
nformation/Guidances/ucm073102.pdf.

Despite having an uncontested knowledge of the 44-50%
withdrawal occurrence rates in Cymbalta patients, Eli Lilly
designed and endorsed a Cymbalta label that omitted that
information and instead assured physicians and patients that the
risk of withdrawal symptoms was only "1% or greater;" a lower
occurrence rate than which Eli Lilly knew to be true.

Defendant

denies this statement in part and states that the warnings in
the Cymbalta label relevant to discontinuation-emergent adverse
events are directed at physicians as required by FDA regulation.
Plaintiff's additional statements are argument and without
citation to specific admissible evidence, and are therefore
denied.

The "1% or greater" language was on the Cymbalta label
on September 29, 2008 when Caruana first saw Plaintiff to treat
(See Caruana Dep. Ex. 2.)

him for his depressive disorder.

Caruana testified that she had reviewed the product
label and Physician's Desk Reference ("PDR") entry for Cymbalta
prior to prescribing the antidepressant to Plaintiff.

18

(See

Caruana Dep. 96:12-24, 104:23-105:8.)

Defendant denies this

statement and states that Caruana testified that she had the
Cymbalta product labeling in her office at the time that she
prescribed Cymbalta to Plaintiff and that it was a "source of
information that [she] was aware of and familiar with" at that
time (Caruana Dep. at 104:18-105:8) and also testified that she
thought that "[a]t some point in time" she had "avail[ed
her]self of the product labeling contained in the PDR for
Cymbalta."

(Id. at 96:12-15.)

Caruana had significant experience prescribing
antidepressant medications by September 2008, although Cymbalta
had only been on the market for approximately three to four
years by this time.

The Defendant denies this statement as

being without citation to specific admissible evidence and
states that Cymbalta was first approved for use in the United
States on August 3, 2004

(see Jones Deel. Ex. 3 (Letter from

Robert Temple to Eli Lilly & Co., Inc.

(Aug. 3, 2004)) and that

Caruana was familiar in September 2008 "with the various
psychiatric medicines that could be used to treat someone in Mr.
McDowell's condition" and that at any point in her over twenty
years of experience, approximately 90% of her patients were

19

taking either an antidepressant or antianxiety medication.
(Caruana Dep. 20:8-13, 70:12-71:2.)

In September 2008, Caruana had no knowledge of the
clinical studies conducted by Eli Lilly or that withdrawal
symptoms were occurring in 44-50% of Cymbalta patients.

Until

the time of her deposition on June 6, 2014, Caruana had never
seen the 2005 JAD article which explained Cymbalta's 44-50%
occurrence rate for withdrawal symptoms:

Q.

So this is the journal article that Mr.
Imbroscio made reference to. It's cited in
the - the document that I marked as Exhibit
3 .
. And the title is "Symptoms Following
Abrupt Discontinuation of Duloxetine
Treatment in Patients with Major Depressive
Disorder" .
. It's published in the
Journal of Affective Disorders, correct?

A.

Yes.

Q.

Okay. Did anyone from Lilly ever give you
that article prior to your prescribing Jesse
McDowell Cymbalta in 2008?

A.

I do not believe so.

Q.

Do you have any idea or recollection as we
sit here today as to whether or not you ever
read that article?

A.

No,

I never have.

(See Caruana Dep. 153:7-154:11.)

20

Defendant denies this statement in part and admits
that the excerpt from Caruana's testimony is correctly
reproduced and that Caruana had not read the 2005 JAD Article
prior to prescribing Cymbalta for the Plaintiff but understood
from her clinical practice that "most patients who stop
[Cymbalta] abruptly are going to get .
abruptly," because "[p]atients report[ed]

. symptoms of stopping
it to [her]"

(Caruana

Dep. at 33:4-14) and that at least half of her patients who
discontinued an SNRI or SSRI abruptly experienced some type of
discontinuation symptom.

(See id. at 41:5-23; 57:16-58:11.)

The statement that "Nurse Caruana had no knowledge .
. that withdrawal symptoms were occurring in 44-50% of Cymbalta
patients" is therefore denied.

Caruana did not possess a separate independent
knowledge of Cymbalta's 44-50% withdrawal occurrence rate among
its users:

Q.

Okay. And then "Lilly reported symptoms in
44 percent of patients discontinuing after
nine weeks or less and 50 percent longerterm trials. About 10 percent of withdrawal
events and short-term trial were related as
'severe' and 53.7 had not yet resolved after
one or two weeks of observation"; have I
read that correctly?

21

A.

Yes.

Q.

Is this information that had been provided
to you by September of 2008 by Eli Lilly?

A.

I don't believe so.

(Caruana Dep. 134:5-135:16.)

The Defendant denies this

statement in part and admits that Caruana's testimony is
correctly reproduced here, with the exception of the third
sentence in counsel's question, which should correctly be
written as "About 10 percent of withdrawal events and short-term
trials were rated as 'severe'

." but denies the statement

about Caruana's knowledge regarding rates of discontinuationemergent adverse events among Cymbalta users who abruptly
discontinue the drug.

Once provided with accurate risk information for the
first time, Caruana's testimony was that had that risk
information been provided to her in 2008, she would have treated
Plaintiff with a drug other than Cymbalta:

Q.

If the information that I read to you,
flipping back again to Exhibit 3, if that if the information in the data that we just
looked over relating to the 44 percent after
nine weeks and 50 percent long-term trials,
if that had appeared in a black box warning
in September of 2008, how would you have
weighed that information in the black box?

22

----------------------------------

A.

I would - I would look at that very
carefully

Q.

And can you elaborate a little bit by what
you mean look at it very carefully and put
that in context of Jesse McDowell if you
could?

A.

If I knew that it could be potentially as
severe as the withdrawal from Effexor, then
I would choose something else.

Q.

I'm sorry?

A.

I would choose another drug.

(Caruana Dep. 137:18-138:16.)

The Defendant denies this

statement in part and admits that Caruana's testimony is
correctly reproduced.

Plaintiff eventually discontinued Cymbalta around June
of 2012.

In a matter of days following his last pill, he

immediately began to suffer symptoms of withdrawal such as
"brain zaps," insomnia, vertigo, nausea, constant dizziness,
numbness and burning in his right hand, and, perhaps most severe
of all, suicidal thoughts.

(See Pl.'s Dep. 164:2-25.)

The Defendant denies this statement in part and admits
that the Plaintiff discontinued Cymbalta in mid-June 2012 and
that he has testified that he experienced, over a period of time
23

ranging from "within a few days" from when he last took a
Cymbalta pill to spring of 2013, "brain zaps," headaches,
dizziness, insomnia, and suicidal thoughts.
166:17.)

(Id. at 163:24-

Defendant denies the contention that the Plaintiff

suffered from vertigo, nausea, or numbness and burning in his
right hand in the absence of admissible evidence and states when
asked to describe his injuries at his deposition, the Plaintiff
did not describe any of those three symptoms and denied that he
had experienced additional symptoms.

(Id. at 164:19-20 ("Q.

Anything else? A. Not that I can -- not that I -- that I
remember.") . )

These symptoms were continuous and led to being
temporarily bedridden and the insolvency of his young and
growing business.

Plaintiff testified that while most of the

withdrawal symptoms he experienced post-discontinuation have
since subsided, he continues to live with the memory and fear of
a return of his suicidal thoughts.

(Id. at 184:21-185:7.)

The

Defendant denies the statement in part in the absence of
specific admissible evidence in support of Plaintiff's
contention that his symptoms were continuous or led to him being
temporarily bedridden and to the insolvency of his business and
note that the Plaintiff has made no claim for lost wages.

24

at 190:21-191:2.)

The Defendant admits that Plaintiff's brain

zaps, dizziness, and headaches have subsided since his earlier
experience of them and that Plaintiff testified that the "memory
and experience that [he] had with that, with quitting Cymbalta,
will affect [him] negatively" because it was "scary" that he had
in the past experienced suicidal thoughts (Id. at 184:21-185:3)
and states that the Plaintiff has not had a suicidal thought
since 2012, and no medical professional or mental health
professional has told him that those thoughts are likely to
recur.

(Id. at 185:8-16.)

The Applicable Standard

Summary judgment is appropriate only where "there is
no genuine issue as to any material fact and .

. the moving

party is entitled to a judgment as a matter of law."
Civ. P. 56(c).

Fed. R.

A dispute is "genuine" if "the evidence is such

that a reasonable jury could return a verdict for the nonmoving
party."

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248,

106 S. Ct. 2505, 91 L.Ed.2d 202

(1986).

The relevant inquiry on

application for summary judgment is "whether the evidence
presents a sufficient disagreement to require submission to a
jury or whether it is so one-sided that one party must prevail

25

as a matter of law."

Id. at 251-52.

A court is not charged

with weighing the evidence and determining its truth, but with
determining whether there is a genuine issue for trial.
Westinghouse Elec. Corp. v. N.Y. City Transit Auth., 735 F.
Supp. 1205, 1212 (S.D.N.Y. 1990)

(quoting Anderson, 477 U.S. at

24 9) .

A fact is "material" only if it will affect the
outcome of the suit under applicable law, and such facts
"properly preclude the entry of summary judgment."
477 U.S. at 248.

Anderson,

Disputes over irrelevant facts will not

preclude summary judgment.

Id.

The goal is to "isolate and

dispose of factually unsupported claims."

Celotex Corp. v.

Catrett, 477 U.S. 317, 323-24, 106 S. Ct. 2548, 91 L.Ed.2d 265
(1986).

"[I]t ordinarily is sufficient for the movant to point
. on an essential element of the non-

to a lack of evidence
movant's claim .

[T] he nonmoving party must [then] come

forward with admissible evidence sufficient to raise a genuine
issue of fact for trial .

II

536 F.3d 140, 145 (2d Cir. 2008)

Jaramillo v. Weyerhaeuser Co.,
(internal citations omitted);

see also Goenaga v. March of Dimes Birth Defects Found., 51 F.3d
14, 18 (2d Cir. 1995)

("Once the moving party has made a

properly supported showing sufficient to suggest the absence of

26

------------·---·-----

any genuine issue as to a material fact,

the nonmoving party .

. must come forward with evidence that would be sufficient to
support a jury verdict in his favor.").

"The evidence of the

non-movant is to be believed, and all justifiable inferences are
to be drawn in his favor."

Anderson,

477 U.S. at 255.

The Discontinuance Warning is Adequate

Under New York law, a manufacturer's duty to warn of
the risks of a prescription medicine runs to the prescribing
medical professional, not an individual patient.
Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993)

See Martin v.

("Warnings for

prescription drugs are intended for the physician .

[T] he

manufacturer's duty to caution against a drug's side effects is
fulfilled by giving adequate warning through the prescribing
physician, not directly to the patient.").

The Defendant has a

duty to warn prescribing medical professionals of "potential
dangers in its prescription drugs that it knew, or, in the
exercise of reasonable care, should have known to exist."
Martin, 628 N.E.2d at 1311.

This duty applies to failure to

warn claims based both in strict liability and negligence.
Mulhall v. Hannafin, 841 N.Y.S.2d 282, 285 (N.Y. App. Div.
2007) .

27

See

-·-·····-·---------

------------

Under the "informed intermediary" doctrine, "the
manufacturer's duty to caution against a drug's side effects is
fulfilled by giving adequate warning through the prescribing
physician, not directly to the patient."

Martin, 628 N.E.2d at

1311 (emphasis added); see also Spensieri v. Lasky, 723 N.E.2d
544, 549 (N.Y. 1999).

The prescriber, "whose duty it is to

balance the risks against the benefits of various drugs and
treatments and to prescribe them and supervise their effects,"
is thus the "informed intermediary" between the manufacturer and
the individual patient.

Martin, 628 N.E.2d at 1311; see also

Wolfgruber v. Upjohn Co., 423 N.Y.S.2d 95,
1979) aff'd, 52 N.Y.2d 768

96 (N.Y. App. Div.

(N.Y. 1980); Ames v. Apothecon, Inc.,

431 F. Supp. 2d 566, 573 (D. Md. 2006)

(physicians "are presumed

to have considerable medical training as well as the ability to
access the medical literature if they require additional
information").

The adequacy of the warning provided to a

prescriber may be determined as a matter of law.

See, e.g.,

Martin, 628 N.E.2d at 1312.

A warning is adequate as a matter of law "if it
provides specific detailed information on the risks of the
drug."

Martin, 628 N.E.2d at 1312.

28

Specifically, "[i]t has

long been the law in New York that prescription medicine
warnings are adequate when .

. information regarding 'the

precise malady incurred' was communicated in the prescribing
information."

Alston v. Caraco Pharm., Inc.,

670 F. Supp. 2d

279, 284

(S.D.N.Y. 2009)

(quoting Wolfgruber, 423 N.Y.S.2d at

96-97) .

In making this determination, the Court should consider

factors including "whether the warning is accurate, clear,
consistent on its face, and whether it portrays with sufficient
intensity the risk involved in taking the drug."

Id.

A warning

is clear if it is "direct, unequivocal and sufficiently forceful
to convey the risk."

Id. at 1313.

The warning should also be

evaluated as a whole and not through the nitpicking prism of an
interested legal advocate after the fact:

While a meticulous examination and parsing of
individual sentences in the insert may arguably
reveal differing nuances in meaning or variations
in emphasis as to the seriousness of a side
effect, any resulting vagueness may be overcome
if, when read as a whole, the warning conveys a
meaning as to the consequences that is
unmistakable.

Id.

Federal courts applying New York law apply this
standard.

See, e.g., Yates v. Ortho-McNeil-Janssen Pharm.,

Inc., No. 3:09-oe-40023, 2014 WL 1369466, at *5 (N.D. Ohio Apr.
29

7, 2014)

(applying New York law)

("Because the document

explicitly warned that the product could cause strokes, the
Court finds that the warning is sufficient to meet the
Defendants' duty to provide adequate warnings to treating
physicians regarding a possible risk of the product."); In Re
Accutane Prods. Liab., MDL No. 1626, 2012 WL 3194954, at *l, *45 (M.D. Fla. July 24, 2012)

(applying New York law)

("The

Physician Package Insert plainly and prominently identified
inf larmnatory bowel disease by name as a possible consequence of
taking Accutane.

This risk information appeared in the

'WARNINGS' and 'ADVERSE REACTIONS' sections of the insert.

It

also identified the cormnon symptoms of IBD and instructed what
should be done if those symptoms appeared.")
original).

(emphasis in the

In sum, "[w]here the warning given to the

prescribing physician by the manufacturer through the
Physician's Desk Reference (PDR), package inserts and other
literature gives specific detailed information on the risks of
the drug, the manufacturer has been held absolved from liability
as a matter of law."

Wolfgruber, 423 N.Y.S. 2d at 97.

Since Cymbalta's initial 2004 approval for the
treatment of major depressive disorder, the FDA-approved label
for the medicine has included a three-paragraph warning on the

30

risk of symptoms upon discontinuation of Cymbalta therapy.

That

warning has included a statement about the occurrence of
discontinuation symptoms in the Cymbalta clinical trial
experience, including the important fact that the rate was
significantly higher in Cymbalta patients than patients on
placebo; a recitation of the specific symptoms possible upon
Cymbalta discontinuation (including the symptoms alleged by the
Plaintiff) ; and guidance on the appropriate protocol for safe
discontinuation of the medicine.

The elements of the Cymbalta discontinuation warning
"portray[] with sufficient intensity the risk involved in taking
the drug."

Martin, 628 N.E.2d at 1312.

The Highlights of

Prescribing Information section of the Cymbalta label in effect
at the time of the Plaintiff's initial prescription warns that
discontinuation "[m]ay result in symptoms, including dizziness,
nausea, headache, fatigue, paresthesia, vomiting, irritability,
nightmares, insomnia, diarrhea, anxiety, hyperhidrosis, and
vertigo."

The Dosage and Administration section of the Cymbalta
label warns that "[s]ymptoms associated with discontinuation of
Cymbalta and other SSRis and SNRis have been reported. A gradual

31

reduction in the dose rather than abrupt cessation is
recommended whenever possible" and directs prescribers to the
more detailed warning provided in the label's Warnings and
Precautions section.

The Warnings and Precautions section of the Cymbalta
label additionally provides the risks of discontinuation
symptoms.

The Cymbalta label sets out the risk of symptoms
arising from "abrupt or tapered discontinuation" and warns that,
in placebo-controlled clinical trials, discontinuation symptoms
occurred "at a significantly higher rate in duloxetine-treated
patients compared to those discontinuing from placebo."

See

Gurski v. Wyeth-Ayerst Div. of Amer. Home Prods. Corp., 986 F.
Supp. 654, 654

(D. Mass. 1997)

(granting summary judgment where

warning "cautioned the plaintiff specifically regarding the
probability, nature, and gravity of the precise condition that
she sufficiently suffered").

The Cymbalta label includes a detailed catalog of
symptoms possible upon discontinuation.

Indeed, the symptoms

the Plaintiff alleges that he experienced after stopping his

32

Cymbalta treatment are identified in the discontinuation
warning.

See Alston,

670 F. Supp. 2d at 284

medicine warnings are adequate when, as here,

("[P]rescription
information

regarding 'the precise malady incurred' was communicated in the
prescribing information.")

(quoting Wolfgruber,

423 N.Y.S.2d at

96-97).

During the period relevant here, the label included
approximately a dozen symptoms occurring "at a rate greater than
or equal to 1%" in placebo-controlled clinical trials for
Cymbalta: "dizziness, nausea, headache,

fatigue, paresthesia,

vomiting, irritability, nightmares, insomnia, diarrhea, anxiety,
hyperhidrosis and vertigo."

This method of communicating information on individual
symptoms appearing in clinical trials is consistent with the
accepted practice of identifying such individual adverse events
observed at or above a specified threshold and in accord with
FDA regulations and guidance directing that the label "list the
adverse reactions identified in clinical trials that occurred at
or above a specified rate appropriate to the safety database."
21 C.F.R. § 201.57 (c) (7); see also U.S. FOOD AND DRUG ADMIN.'
GUIDANCE FOR INDUSTRY: ADVERSE REACTIONS SECTION OF LABELING FOR HUMAN

33

PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS-CONTENT AND FORMAT ( 2 0 0 6) ,
available at
www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformat
ion/guidances/ucm075057.pdf.

In addition, the label included an

additional subset of potential symptoms reported upon
discontinuation of products within the SNRI class to which
Cymbalta belongs and warns that "patients should be monitored"
for all of the symptoms identified in the warning.

Section 5.1 of the Warnings and Precautions in the
Cymbalta label additionally provides an account of the clinical
worsening and suicide risks attendant to taking antidepressants,
including in the case of downward adjustments in the dosage of
an antidepressant.

The label warns:

All patients being treated with antidepressants
for any indication should be monitored
appropriately and observed closely for clinical
worsening, suicidality, and unusual changes in
behavior, especially during the initial few
months of a course of drug therapy, or at times
of dose changes, either increases or decreases.
These suicidality warnings are well-known in the medical
community.

See u. s. FOOD AND DRUG ADMIN. ' PUBLIC HEALTH ADVISORY:

SUICIDALITY IN ADULTS BEING TREATED WITH ANTIDEPRESSANT MEDICATIONS (2005),

34

--····-·····-····

-----------------------

www.fda.gov/Drug/DrugSafety/PostmarketDrugSafetyinformationforPa
tientsandProviders/ucm053169.htm.

The discontinuation warning speaks to the "severity"
and "duration" of potential discontinuation symptoms within the
SNRI class: "Although these events are generally self-limiting,
some have been reported to be severe."

The label identifies

symptoms that, by their nature, have the capacity to be severe
and that are not, by definition, self-limiting, which appear in
the label's WARNINGS and PRECAUTIONS section and which, by law,
must include all "clinically significant adverse reactions
(including any that are potentially fatal, are serious even if
infrequent)."

21 C.F.R. § 201.57(c) (6); see also Ames, 431 F.

Supp. 2d at 569 n. 9 (recounting opinion of plaintiffs' expert
that "most 'serious' adverse reactions are listed in the
Warnings section"); Martin, 628 N.E.2d at 1312 (noting that
Warnings section "deals with side effects of graver consequences
than the Adverse Reactions section").

The Cymbalta discontinuation warning devotes a
paragraph to advising prescribers of the appropriate means of
taking a patient off the medicine.

Section 5.1 of Warnings and

Precautions advises in connection with the suicidality warning,

35

"If the decision has been made to discontinue treatment,
medication should be tapered, as rapidly as is feasible, but
with recognition that discontinuation can be associated with
certain symptoms."

Section 5.6 states: "Patients should be

monitored for these symptoms when discontinuing treatment with
Cymbalta.

A gradual reduction in the dose rather than abrupt

cessation is recommended whenever possible.

If intolerable

symptoms occur following a decrease in the dose or upon
discontinuation of treatment, then resuming the previously
prescribed dose may be considered."

The Plaintiff contends that the Cymbalta
discontinuation warning was both inadequate because it did not
include the frequency of patients with discontinuation symptoms
in the 2005 JAD Article, and misleading, because it utilized a
threshold of "greater than or equal to 1%" to identify
individual discontinuation events.

(Pl.'s Mem. at 6-8.)

However, courts have refused to graft onto the
adequacy standard a requirement that a package insert must
include specific adverse event frequencies.

See Hurley v.

Lederle Labs., Div. of Am. Cyanamid Co., 651 F. Supp. 993, 1002
(E.D. Tex. 1986)

("The plaintiff cites no authority for the

36

----------------------------------

proposition that a drug manufacturer has a duty to warn
prescribing physicians of the rate of adverse reactions.

As a

practical matter, this would be extremely difficult, perhaps
impossible, with respect to a drug like the DPT vaccine, which
has many possible harmful side effects.")
Wyeth Labs., Inc., No. 84-2002, slip op.

(quoting Smith v.
(S.D. W.Va. Aug. 21,

1986)), rev'd on other grounds 863 F.2d 1173 (5th Cir. 1988);
see also Percival v. Am. Cyanamid Co., 689 F. Supp. 1060, 1064
(W.D. Okla. 1987).

The Cymbalta warning closely parallels the warning
that was found adequate as a matter of law in Alston.
Supp. 2d 279.

670 F.

The Alston warning stated in part that

"[w]ithdrawal symptoms may occur if ULTRAM is discontinued
abruptly.

. These symptoms may include: anxiety, sweating,

insomnia.

and rarely hallucinations."

Id. at 282.

It was

held that the warning warned about the injuries sustained by the
plaintiff, despite lacking precise frequencies for each
withdrawal event or for withdrawal symptoms as a category.
id. at 284-85.
duty to warn.

See

As a result, the manufacturer discharged its
Id.

The Cymbalta discontinuation warning

likewise specifically identifies potential discontinuation
symptoms.

The warning also articulates the seriousness of the

37

risk, as required by Martin: it states that a number of these
symptoms occurred "at a significantly higher rate" in patients
taking the drug than in those taking a placebo and that some
symptoms had been reported to be "severe."

The Plaintiff has contended that the Cymbalta label
misleadingly suggests that discontinuation symptoms "occurred in
only 1% of patients."

(Pl.'s Mem. at 8.)

Caruana, an

experienced medical professional, expressly rejected that
interpretation.

(Caruana Dep. 47:12-18

("Q. And then it goes on

-- it lists all these events, and it says 'occurred at a rate
greater than or equal to 1 percent.'

Does that mean to you that

there's only a 1 percent chance of any of this thing
these things happening?

any of

A. No.").)

Using a numerical threshold for the inclusion of
adverse events in a label is an appropriate, standard
methodology for identifying adverse events arising with
sufficient frequency to warrant inclusion in the product label.
Pursuant to FDA regulations and guidance, manufacturers are to
identify the "frequency cutoff" than or equal to 1%" language
in the product label.

the equivalent of the "greater

for potential adverse reactions

See 21 C.F.R. 201.57(c)(7)(ii)(A); see

38

also GUIDANCE FOR INDUSTRY: ADVERSE REACTIONS SECTION OF LABELING FOR HUMAN
PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS 10 ("The frequency cutoff
should be noted in the listing or table header,

in the text

accompanying the listing or table, or in a footnote.").

Taken together, the Cymbalta warning is adequate as a
matter of law because it is "accurate, clear, consistent on its
face" and "portrays with sufficient intensity the risk involved
in taking the drug."

See Martin,

628 N.E.2d at 1312.

The Discontinuance Warning Was Not the Proximate Cause of
Plaintiff's Injuries

Under New York law, "where the treating physician is
independently aware" of potential adverse events, that knowledge
is "an intervening event relieving the manufacturer of any
liability to a patient under the failure to warn theory."
Banker v. Hoehn, 718 N.Y.S.2d 438,
see also Alston,

440-41

(N.Y. App. Div. 2000);

670 F. Supp. 2d at 286 ("The Plaintiff has not

shown that a failure to warn .

. was the proximate cause of

his injuries, as his physicians were aware of the risks .

.");

Figueroa v. Boston Scientific Corp., 254 F. Supp. 2d 361, 370
(S.D.N.Y. 2003).

A physician's existing awareness of a

potential risk or side effect thus "sever[s] the causal [chain]"
39

between an allegedly inadequate warning and a plaintiff's
injury.

Glucksman v. Halsey Drug Co., 553 N.Y.S.2d 724, 726

(N.Y. App. Div. 1990).

Caruana testified that, based on her clinical
experience and training, she was aware of the risk of
discontinuation symptoms with abrupt cessation of Cymbalta
treatment.

(Caruana Dep. 33:04-34:08, 38:02-23.)

Upon reviewing the discontinuation symptoms listed on
Cymbalta's label during her deposition, Caruana testified that
she was independently aware of the specific symptoms described
in the label.

(Caruana Dep. 39:13-40:24.)

In describing her clinical experience with SSRis and
SNRis, Caruana testified that "at least half" of her patients
experience some discontinuation symptom upon an abrupt cessation
of treatment.

(Caruana Dep. 41:05-19.)

With respect to

paresthesia, the "electric shock" sensation, Caruana testified
that they occur "very frequently" upon discontinuation.
(Caruana Dep. 40:22-24.)

When confronted with the specific data

on discontinuation symptoms reflected in the 2005 JAD Article on
the rate of patients with discontinuation symptoms upon abrupt

40

discontinuation in the reported studies 22.9% on placebo -

44.3% on Cymbalta and

Caruana volunteered that she had "seen that .

. many people have those problems."

(Caruana Dep. 58:10-11.)

The Plaintiff's central claim is that the Defendant
misled medical professionals about the rate of discontinuation
symptoms by listing the events seen in the clinical trials "at a
rate greater than or equal to 1%," consistent with the Federal
Regulations.

See 21 C.F.R. § 201.57 (c) (7) (ii) (A).

However,

Caruana expressly testified that she was not misled in the way
Plaintiffs suggest:

Q.

. Does that mean to you that there's
only a 1 percent chance of any of this thing
- any of these things happening?

A.

No.

(Caruana Dep. 47:14-18.)

A prescriber's independent knowledge of the risks of a
drug or medical device breaks the chain of proximate causation.
In Ohuche v. Merck & Co.,

903 F. Supp. 2d 143 (S.D.N.Y. 2012),

the physician who had prescribed the plaintiff a vaccine for
shingles "testified at deposition that she was aware of the
adverse reactions associated with ZOSTAVAX."

41

Id. at 151.

The

--------------

--------

manufacturer's alleged failure to adequately disclose the risks
of the drug, therefore, was not the proximate cause of the
plaintiff's injuries.

Id. at 151-52.

Similarly, in Banker v.

Hoehn, "there [was] no question" that the treating physician
"was fully cognizant of the potential of hypertrophic scarring"
from the use of an argon laser to treat a facial birthmark.
N.Y.S.2d at 441.

718

That knowledge was an "intervening event" in

the causal chain which "reliev[ed] the manufacturer of any
liability to a patient under the failure to warn theory."
at 440-41.

Id.

See also Figueroa, 254 F. Supp. 2d at 370 (holding

that no proximate causation existed where "a treating physician
is well aware of the risks of a medical device, independent of
any warning by the manufacturer"); Glucksman, 553 N.Y.S.2d at
726-27

(holding that plaintiff could not show proximate cause

where treating physician had independent knowledge of the risks
posed by treatment, because "physician's decision not to inform
the plaintiff of the risk .

. was an intervening cause.").

Another federal court has recently held that a
prescribing physician's independent knowledge of potential
Cymbalta discontinuation symptoms made it impossible for the
plaintiffs to establish proximate cause.

See Carnes v. Eli

Lilly and Co., C/A No. 0:13-591, 2013 WL 6622915, at *7

42

(D.S.C.

--------------------------

Dec. 16, 2013).

There, the plaintiffs, represented by the same

lawyers as in this case, made allegations that the "1%" figure
in the Cymbalta label was misleading.

Because the prescribing

doctor in Carnes had "independent knowledge of the risk of
withdrawal symptoms through his training and experience" and
independent of the Cymbalta label, the court ruled that
plaintiffs could not prove proximate cause.

Id. at *5-6.

The Plaintiff seeks to distinguish Carnes by noting
that the South Carolina District Court found that the
prescribing physician in Carnes had independent knowledge of the
extent of Cymbalta's 44-50% withdrawal symptom occurrence rate
and that the physician would still have prescribed Cymbalta to
his patient had there been a warning on the label of the sort
the Plaintiffs argue for in the case at bar.
WL 6622915, *7

See Carnes, 2013

("Dr. Knight also testified that 'more than half'

of his patients experienced some type of withdrawal symptom
following abrupt discontinuation of Cymbalta.").

See also id.

at *5 ("Dr. Knight testified that, had he been provided the
warning Plaintiffs allege would have been adequate, he still
would have prescribed Cymbalta to Mr. Carnes in the summer of
2011.").

43

Here Caruana testified that she had knowledge of the
risks of abrupt discontinuation independent of the information
provided by Eli Lilly and that she was not misled by the
discontinuance warning claim.

Thus, even under Plaintiff's

theory, the Defendant did not proximately cause the Plaintiff's
injuries and is relieved of liability.
at 441.
468

See Banker, 718 N.Y.S.2d

See also Porterfield v. Ethicon, Inc., 183 F.3d 464,

(5th Cir. 1999)

(no proximate cause where physician was

independently aware of possible risks of using medical device
through experience and review of literature); Odom v. G.D.
Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992)

("[T]he

manufacturer cannot be said to have caused the injury if the
doctor already knew of the medical risk."); Kirsch v. Picker,
Int'l, Inc., 753 F.2d 670, 671 (8th Cir. 1985)

("Picker's

failure to warn Dr. Murphy could not have been the proximate
cause of Kirsch's injury if Murphy was already aware of the
cancer risks associated with radiation therapy."); Ames,

431 F.

Supp. 2d at 573 ("[T]he warnings are intended to be read by
learned intermediaries who are presumed to have considerable
medical training as well as the ability to access the medical
literature if they require additional information.").

44

Furthermore, under New York's proximate cause
standard, "a plaintiff must demonstrate that had a different,
more accurate warning[] been given, his physician would not have
prescribed the drug in the same manner."

Alston,

2d at 285; see also Mulhall, 841 N.Y.S. 2d at 287
had to show that had the warning been different,

670 F. Supp.
("[P]laintiffs
Dr. Hannafin

would have departed from her normal practice and used another
device.").

Summary judgment is appropriate where a plaintiff

fails to establish that a prescribing physician's decision to
prescribe a particular medication would have changed had a
different warning been given.
Corp.,

913 F. Supp. 195, 200

Id.; see also Erony v. Alza
(S.D.N.Y. 1995)

("An act cannot be

the 'substantial cause' if the injury would have occurred
regardless of the content of defendant's warning.").

In her deposition, Caruana testified that a different
warning containing the information Plaintiff alleges was missing
from the Cymbalta labeling would not have changed her decision
to prescribe Cymbalta to the Plaintiff:

Q.

If the physician package insert, the
prescribing information[,] had said not
that the following symptoms occur[ ]at a
rate equal to .
. or greater than .
one percent, but it said that these events
occur in at least one patient in the
clinical trials 44.3 percent of the time
45

while they occur in placebo
discontinuation 22.9 percent of the time,
would that have [had] any impact on your
decision to use Cymbalta?
A.

No [.] [B] ecause in actual practice, we' re
talking about discontinuation and I've
seen that many people have those problems.

(Caruana Dep. 57:20-58:11.)

Under examination by the Plaintiff's attorney, when
asked whether information that discontinuation symptoms occurred
in "40 to 50 percent" of patients in clinical studies would
impact her decision to prescribe Cymbalta, Caruana testified
that "it would affect not the prescribing so much."
Dep. 129:02-03.)

(Caruana

Caruana did also testify that if the rate were

indeed so high (in contrast to her own experience), she might
have decided to emphasize to patients the importance of tapering
off of Cymbalta (Id. at 129:04-12), but she did not say that it
would have impacted her prescribing decision.

Caruana explained

that she relies on her clinical experience more than labeling
language:

Q.

And that's why I'm asking ... if you had
been provided this information in 2008,
what would that have done in your mind in
comparing [the effects of] Cymbalta [to
other drugs,] with respect to withdrawals
specifically?

46

--------------------------------------

A.

I'd still have to go with my experience
with patients [,] [ s] o that would temper
what I'm reading here [about
discontinuation risk]
[b]ecause my
experience with patients doesn't lead me
to believe that it is in the same league
[as Effexor's high rate of discontinuation
symptoms] .

(Caruana Dep. 132:13-25.)

Caruana also testified that "if [she]

knew that

[withdrawal from Cymbalta] could be potentially as severe as the
withdrawal from Effexor,

[another antidepressant therapy,] then

[she] would choose something else."

(Caruana Dep. 138:12-14.)

Caruana distinguished Effexor as "the one drug [she] really
dislike[s] because of the discontinuation syndrome that happens
almost on a daily basis if you don't take it on time .

.

'"

(Caruana Dep. 76:21-24), and testified that in her experience
with Cymbalta (which she estimated she has prescribed to over
100 patients), Cymbalta "is [not]
on discontinuation symptoms.

in the same league" as Effexor

(Caruana Dep. 29:14-17; 132:13-

25.)

Caruana's testimony that she had not read the 2005 JAD
Article and that it "may have" been relevant to her decision-

47

----------------------------------------

making process (see Pl's. Mem. 10; Caruana Dep. 134:18-23) does
not bar summary judgment.

None of the cases that the Plaintiff

has cited demand that a physician be independently aware of the
precise frequency of an adverse event.

In Ohuche v. Merck &

Co., the product information provided to physicians about the
shingles vaccine noted specific numbers of patients who suffered
from the adverse event in question.

903 F. Supp. 2d at 146.

The prescribing physician had never reviewed that product
information, the PDR entry for the vaccine, or any publications
about the vaccine by the FDA or in medical journals.
146-47.

See id. at

Nonetheless, the court concluded that there was no

proximate cause because the physician had independent, general
knowledge about the possibility of side effects.

Id. at 147,

151-52; see also Glucksman, 553 N.Y.S.2d at 725-26 (finding
prescriber's independent awareness that particular adverse event
was a "possible adverse reaction associated with" the medication
prevented plaintiff from demonstrating proximate cause).

The Plaintiff seeks to defeat summary judgment for
lack of proximate cause by relying on Caruana's testimony that
she might have prescribed a different medicine to the Plaintiff
if Cymbalta discontinuation "could be potentially as severe as
the withdrawal from Effexor," a different antidepressant.

48

(Id.

·----------------------·----·--

at 138:12-16.)

Under questioning by counsel for the Plaintiff,

Caruana testified about her experience with the drug Effexor,
which she characterized based on her clinical experience and
discussions with other physicians as "remarkable in causing
severe [withdrawal] reactions almost on a daily basis," even
though she did not think she had seen any empirical data on that
point.

(See id. at 76:21-79:11.)

Counsel then asked Caruana to

assume that she had been provided with "information or material
or data that showed that Cymbalta was worse" than Effexor with
regard to withdrawal and asked what impact that would have on
her prescribing decision, to which she agreed only that she
would give such information attention.

(See id. at 122:7-24.)

Caruana testified that if she knew that Cymbalta was as severe
as Effexor she would have chosen another drug for the Plaintiff.
(Caruana Dep. 137:18, 138:16.)

However, there is no evidence in this record that
Cymbalta and Effexor have equivalent discontinuation profiles.
Caruana's clinical experience, having prescribed antidepressants
to thousands of patients was that Cymbalta's discontinuation
effects were not as severe as those experienced upon abrupt
withdrawal from Effexor.

(Id. at 68:10-13, 70:18-71:2.)

49

Counsel for the Defendant properly objected to the
line of questioning that resulted in Caruana's testimony as
lacking foundation and calling for speculation due to the
absence in the record of any support for the claim that Cymbalta
and Effexor have equivalent discontinuation profiles and
Caruana's testimony contradicting that suggestion.
Dep. 138:3-5.)

(See Caruana

The inadmissibility of Caruana's testimony is a

separate, stand-alone ground for rejecting it as a basis for
denying summary judgment.

See Presbyterian Church of Sudan v.

Talisman Energy, Inc., 582 F.3d 244, 264

(2d Cir. 2009)

("[O]nly

admissible evidence need be considered by the trial court in
ruling on a motion for summary judgment." (quoting Raskin v.
Wyatt Co., 125 F. 3d 55, 66 (2d Cir. 1997)).

Because the discontinuance warning was not the
proximate cause of any injuries suffered by the Plaintiff,
summary judgment in favor of the Defendant is appropriate.

The Adequacy of the Discontinuance Warning Bars the Remaining
Claims

The remaining claims, Compl.
design);

~~

warranty);

41-47
~~

(negligence);

~~

~~

48-64

(defective

81-91 (breach of implied

92-103 (negligent misrepresentation);

50

~~

104-114

(fraud);

~~

115-130 (violation of consumer fraud laws) are

barred by the adequacy of the discontinuance warning as
concluded above.

See In Re Accutane, 2012 WL 3194954 at *6

("[U]nder New York law, the adequacy of the warnings, as a
matter of law, precludes any related claims for negligence,
strict liability, breach of warranties, or fraud.").

In

addition, New York does not recognize a design defect theory of
liability for prescription medicines.

See Martin,

628 N.E.2d at

1311 ("[A] prescribed drug, accompanied by adequate warnings, is
'not defective, nor is it unreasonably dangerous.'")

(internal

quotation marks and citation omitted).

Relating a warning theory in terms of "warranty" or
"fraud" does not avoid the implications of an adequate warning.
See, e.g., In re Norplant Contraceptive Prods. Liab. Litig., 955
F. Supp. 700, 709 (E.D. Tex. 1997)

(granting summary judgment on

all claims because "[t]he gravamen of all of Plaintiffs' causes
of action .

. is that Wyeth failed to adequately warn of or

disclose the severity of Norplant's side effects"), aff'd 165
F.3d 374
Md. 2006)

(5th Cir. 1999); Ames, 431 F. Supp. 2d at 567-68

(D.

(granting summary judgment based on proximate cause

and stating defective design, marketing defect, breach of
implied warranty, and negligence claims can be "reduce[d] down"

51

-

--------~--~-----------------------

to failure to warn claims); Jack v. Glaxo Wellcome Inc., 239 F.
Supp. 2d 1308, 1320-22 (N.D. Ga. 2002)

(holding the learned

intermediary doctrine, as adopted by Georgia courts, insulated a
defendant from liability for negligence, strict liability, and
breach of implied warranty claims).

In addition, all of

Plaintiffs' additional claims require that he show proximate
cause, and, as set forth above, that has not been established.

Conclusion

Based on the facts and conclusions set forth above,
the Defendant's motion for summary judgment is granted, and
judgment will entered in its favor dismissing of Plaintiff's
claims.

It is so ordered.

Dated:

New York, New York
November ~' 2014
Robert W. Sweet
U.S.D.J.

52