Chaiken et al v. Bristol-Myers Squibb Company et al

Filing 84

OPINION filed. Signed by Judge Freda L. Wolfson on 10/26/2017. (mps)

*NOT FOR PUBLICATION*
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

IN RE: PLAVIX MARKETING, SALES
PRACTICES AND PRODUCTS LIABILITY
LITIGATION (NO. II)

MDL No. 2418

This Document Relates to:
Civ. Action No.: 134518(FLW)

IRWIN CHAIKEN, et al.,
Plaintiffs,
v.

OPINION

BRISTOL-MYERS SQUIBB, et al.,
Defendants.

WOLFSON, District Judge:
This
Litigation

matter

is

(“MDL”)

a

member

entitled,

In

case
Re:

to

the

Plavix

Multi-District

Marketing,

Sales

Practices and Products Liability Litigation, which is assigned
to the Undersigned.

Plaintiff Barbara Thrope (“Plaintiff” or

“Thrope”) brings the instant suit against Defendants, Bristol
Myers-Squibb

Company

Sanofi-Aventis

U.S.,

(collectively,
injuries

as

(“BMS”),

Sanofi-Aventis

Inc.,

and

“Defendants”),
a

result

of

L.L.C.,

Sanofi-Synthelabo,

alleging
Defendants’

1

U.S.,

that
design,

she

Inc.

suffered

development,

manufacture,
sale

of

promoting,

their

medication.
state

and

prescription

Plaintiff’s
common

Failure-to-Warn,
Negligence.

marketing,

law

drug

Complaint
claims

Defective

distributing,
Plavix,
asserts

against

Design,

an

labeling

and

anti-clotting

various

California

Defendants,

Manufacturing

including

Defect

and

Before the Court is Defendants’ motion for summary

judgment based upon a number of theories, including the learned
intermediary doctrine under California law.
BACKGROUND 1
I.

Plavix
Plavix

is

forming clots.
States

Food

a

drug

that

inhibits

blood

platelets

from

The drug was initially approved by the United
and

Drug

Administration

(“FDA”)

for

use

as

monotherapy, i.e., taken without another drug, in patients with
recent heart attack, stroke, including Transient Ischemic Attack
(“TIA”), or diagnosed peripheral arterial disease.

See Defs.

Statement, ¶ 2.
Taking Plavix is not without risk.

Because it functions by

inhibiting the formation of blood clots, it is well known that
Plavix increases the risk of bleeding.
Plavix

entered

the

market,

its

1

In that connection, when

labeling

included

certain

The following facts are not in dispute unless otherwise
noted. And, the Court will only recount facts that are relevant
to the instant motion.
2

information on that risk.

When Plaintiff was using Plavix in

2011, the drug label provided:
CONTRAINDICATIONS
Active Bleeding
Plavix is contraindicated in patients with active
pathological bleeding such a peptic ulcer or
intracranial hemorrhage.
* * *
WARNINGS AND PRECAUTIONS
General Risk of Bleeding
Thienopyridines, including Plavix, increase the risk
of bleeding. If a patient is to undergo surgery and
an antiplatelet effect is not desired, discontinue
Plavix five days prior to surgery.
Patients with Recent Transient Ischemic Attack (TIA)
or Stroke
In patients with recent TIA or stroke who are at high
risk for recurrent ischemic events, the combination of
aspirin and Plavix has not been shown to be more
effective than Plavix alone, but the combination has
been shown to increase major bleeding.
* * *
ADVERSE REACTIONS
Bleeding:
CAPRIE (Plavix vs. Aspirin)
In CAPRIE, gastro-intestinal hemorrhage occurred at
rate of 2.0% in those taking Plavix, vs. 2.7% in those
taking aspirin; bleeding requiring hospitalization
occurred in 0.7% and 1.1%, respectively. The incidence
of
intracranial
hemorrhage
was
0.4%
for
Plavix
(clopidogrel bisulfate) compared to 0.5% for aspirin.

3

* * *

PATIENT COUNSELING SECTION
Bleeding
Inform patients that they:
• will bruise and bleed more easily
• will take longer than usual to stop bleeding
• should report any unanticipated, prolonged, or
excessive bleeding, or blood in their stool or
urine.

Defs’ Facts, ¶ 4 (citing May 2011 Plavix label as published in
the 2012 Physicians’ Desk Reference at pp. 824-25).
II.

Plaintiff’s Medical History
Hopkins

California.

is

an

83

year-old

woman

from

Spring

Valley,

In September 2011, Plaintiff was hospitalized and

treated for TIA, or the lack of blood flow to the brain, which
can lead to a stroke.
T23:14-24:19.

See Dr. Eva Leonard’s Dep., T16:7-19:22;

Plaintiff,

who

was

a

atherosclerosis, chronic hypertension.
At

the

time

Plaintiff

was

smoker,

had

a

history

of

Id. at T53:11-55:1.
hospitalized,

Plaintiff’s

neurologist, Dr. Amirhassan Bahreman, recommended that Plaintiff
be placed on Plavix, because she was allergic to aspirin and/or
aspirin-intolerant.
T44:3-15;

See

T50:16-T51:10;

Dr.

Bahreman’s

T113:20-114:4.

Dep.,
When

T39:17-40:3;
Plaintiff

was

discharged on September 28, 2011, her primary care physician,

4

Dr. Eva Leonard, prescribed Plavix to Plaintiff, until November
2011, when Plaintiff suffered GI bleeding.
Due

to

the

gastrointestinal

bleeding

allegedly

resulting

from taking Plavix, Plaintiff brings the instant suit against
Defendants asserting product liability related causes of action,
under California state law, for defective design, manufacturing
defect, failure to warn and negligence.
III. Testimony of Plaintiff’s Doctors
The parties questioned both Drs. Bahreman and Leonard at
their deposition.

At his deposition, Dr. Bahreman testified

regarding his decision to prescribe Plavix to Plaintiff.

The

doctor testified that at the time Plaintiff was hospitalized,
based on the fact that Plaintiff might have been intolerant of
aspirin and other factors, he decided that Plavix was the best
option for Plaintiff.
Important

to

Plaintiff

had

taking

aspirin

his

See Dr. Bahreman’s Dep., T50:20-T51-10.

decision,

outstanding
would

GI

Dr.

Bahreman

issues,

exacerbate

and

those

he

recognized

that

determined

conditions.

Id.

that
at

T51:22-T52:23.
Moreover, Dr. Bahreman testified that he was aware that
Plavix has common side effects, such as GI bleeding, and that
aspirin, in his medical opinion, has more GI side effects.
at T55:21-T56:5; T59:1-2.

Id.

The doctor went on to testify that he

is aware of the studies involving Plavix, such as the MATCH
5

trial and the CAPRIE trial.

See Id. at T60:23-T61:8. And, armed

with that knowledge, Dr. Bahreman explained that Plavix, as an
antiplatelet,
T115:9.

would

Specifically

carry

a

bleeding

regarding

risk.

Plaintiff’s

Id.
risk

at

T114:25-

of

taking

Plavix, Dr. Bahreman testified:
Q:
Now, this is a patient [Plaintiff] who you – your
recommendation
was
that
she
be
on
a
single
antiplatelet therapy, correct?
A:

Yes.

That’s correct.

Q:
And you believed that for this patient in her
clinical
situation,
the
benefits
of
being
on
antiplatelet therapy outweighed its risks, correct?
A:

Absolutely.

Q:

Specifically included GI bleeding risk, correct?

A:

That’s correct.

* * *
Q:
And do you believe that based on the information
that you’ve seen today about the patient that this was
a justifiable prescription of Plavix for her under the
circumstances?
A:

At that time, it was justifiable.

Q:
And is there anything that you’ve seen today that
makes you think that it wasn’t justifiable?
A:
Well, no. I don’t think so. You know, when you
have a patient with a history of GI bleed, history of
documented GI bleed, not intolerance, GI bleed, using
those medications always needs an extra caution. So I
would say if I had this patient today, definitely I
would have to look to the data on the documents or
records much more in depth.
And — but — again, this
is the matter of the risk and benefit ratio.

6

Id. at T118:18-T120:10.
Because Dr. Bahreman treated Plaintiff in the context of
Plaintiff’s
decision

to

hospitalization,
administer

the

Plavix

doctor

to

made

Plaintiff.

the

initial

Importantly,

however, Dr. Bahreman explained that it would be the decision of
Plaintiff’s primary care physician, Dr. Leonard, to prescribe
any particular medication upon discharge.

Id. at T112:12-18.

Indeed, Dr. Bahreman insisted that his role is solely to provide
consult and input, but it is up to Dr. Leonard to make a final
decision regarding certain prescriptions, including the decision
to prescribe Plavix to Plaintiff.

Id. at T112:20-23.

In fact,

to be clear, when Plaintiff suffered GI bleeding in November
2011, she was on Plavix that was prescribed by Dr. Leonard.
Similar to Dr. Bahreman, Dr. Leonard testified that, based
on Plaintiff’s medical condition, she had no reservations — even
knowing the risks posed by Plavix — about prescribing Plavix to
Plaintiff:
Q.
[Reading from Plaintiff’s discharge form]
[I]t also says, “But we shall give the Plavix an
opportunity at this time, understanding that the
patient does have a bleeding risk.”
Do you see
where I – the –
A.

Yes.

Q.
Oka.
And what does that sentence mean? Why
is it there, do you think?
A.
Well, apparently, at this hospitalization,
one has to [weigh] the risk and the benefits.
7

Q.

Okay.

A.
She has risks for potential bleeding from
her past history, but when you have symptoms of a
stroke or a TIA, it’s like a red flag. You want
to prevent a stroke. A stroke can kill somebody.
But a stomach ulcer is not necessarily going to
kill somebody.
So it’s sort of weighing the
risks and the benefits . . . .
Id. at T27:14-T28:21.

Indeed, Dr. Leonard acknowledged that

bleeding is the “biggest” risk for taking Plavix.

Id. at T36:9-

13. 2

2

The depositions of Drs. Bahreman and Leonard were taken by
the parties before the instant motion for summary judgment was
filed.
After the deposition of Dr. Bahreman, Plaintiff’s
counsel engaged in ex parte conversations with the doctor for
the purposes of opposing Defendants’ summary judgment motion.
Indeed, after those communications took place, Dr. Bahreman
submitted a declaration, which was attached as an exhibit to
Plaintiff’s opposition brief in this matter, seeking to clarify
certain testimony that he had given during his deposition.
As Defendants pointed out, a previous Order, entered by the
Magistrate Judge early in this litigation, disallowed counsel to
have any ex parte communications regarding liability issues with
the treating physicians of any of the plaintiffs in the MDL,
with no exception for post-deposition communications. See Order
dated April 14, 2011.
Indeed, the Special Discovery Master
extended the Magistrate Judge’s Order uniformly to all cases
nationwide.
Because Dr. Bahreman’s declaration made it apparent that
Plaintiff had discussed liability issues with the doctor,
Defendant sought a ruling from the Special Master to forbid such
ex parte contacts.
However, the Special Discovery Master
declined to limit ex parte communications which take place after
a deposition. Thereafter, Defendants moved before this Court to
sustain certain objections to the Special Master’s ruling.
As
to that motion, I partially reversed the Special Master’s
decision;
I
held
that
counsel
may
not
have
ex
parte
communications with plaintiffs’ treating physicians, including
post deposition, except that counsel may contact a treating
8

IV.

Procedural History
This action, originally filed in Illinois state court, was

removed by Defendants to the United States District Court for
the Northern District of Illinois.

Once removed, the matter was

transferred to this MDL litigation by the MDL Panel.

Defendants

filed the instant motion for summary judgment on August 8, 2017,
and Plaintiff has opposed the motion. 3

The Court held oral

argument on September 12, 2017, wherein the parties’ counsel
appeared, and the Court reserved decision on the record.
DISCUSSION
I.

Summary Judgment
Summary

Judgment

is

appropriate

“if

the

pleadings,

depositions, answers to interrogatories, and admissions on file,
together with the affidavits, if any, show that there is no
genuine issue as to any material fact and that the moving party
is entitled to a judgment as a matter of law.” Celotex Corp. v.
Catrett,

477

U.S.

317,

322,

(1986)

(citing

Fed.

R.

Civ.

P.

physician at the close of discovery and after the resolution of
a summary judgment motion.
On this motion, Defendants object to Plaintiff using Dr.
Bahreman’s declaration in her opposition, and ask this Court to
disregard the declaration based on the fact that it was obtained
by improper ex parte communications and pursuant to the sham
affidavit doctrine.
Because I find that even considering Dr.
Bahreman’s declaration, summary judgment is appropriate, I need
not address those arguments.
3

The
parties
agree
Plaintiff’s claims.

that
9

California

law

applies

to

56(c)).

A

factual

dispute

is

genuine

only

if

there

is

“a

sufficient evidentiary basis on which a reasonable jury could
find for the non-moving party,” and it is material only if it
has

the

ability

to

“affect

the

outcome

of

the

suit

under

governing law.” Kaucher v. County of Bucks, 455 F.3d 418, 423
(3d Cir. 2006) (citing Anderson v. Liberty Lobby, Inc., 477 U.S.
242, 248 (1986)). Disputes over irrelevant or unnecessary facts
will not preclude a grant of summary judgment. Anderson, 477
U.S. at 248. “In considering a motion for summary judgment, a
district court may not make credibility determinations or engage
in any weighing of the evidence; instead, the non-moving party’s
evidence ‘is to be believed and all justifiable inferences are
to be drawn in his favor.’” Marino v. Indus. Crating Co., 358
F.3d 241, 247 (3d Cir. 2004) (quoting Anderson, 477 U.S. at
255);

see

also

Matsushita

Elec.

Indus.

Co.

v.

Zenith

Radio

Corp., 475 U.S. 574, 587, (1986); Curley v. Klem, 298 F.3d 271,
276-77 (3d Cir. 2002).
The

party

moving

for

summary

judgment

has

the

initial

burden of showing the basis for its motion. Celotex Corp. v.
Catrett, 477 U.S. 317, 323 (1986). “If the moving party will
bear the burden of persuasion at trial, that party must support
its motion with credible evidence . . . that would entitle it to
a directed verdict if not controverted at trial.” Id. at 331
(emphasis

and

citation

omitted).
10

On

the

other

hand,

if

the

burden of persuasion at trial would be on the nonmoving party,
the

party

burden

moving

of

evidence

for

summary

production
that

by

negates

judgment

either

an

(1)

essential

may

satisfy

“submit[ting]
element

of

Rule

56’s

affirmative

the

nonmoving

party’s claim” or (2) demonstrating “that the nonmoving party’s
evidence is insufficient to establish an essential element of
the nonmoving party’s claim.” Id. (citations omitted). Once the
movant adequately supports its motion pursuant to Rule 56(c),
the

burden

pleadings

shifts

and

by

to

the

nonmoving

party

her

own

affidavits,

or

to
by

“go
the

beyond

the

depositions,

answers to interrogatories, and admissions on file, designate
specific facts showing that there is a genuine issue for trial.”
Id. at 324 (quotations omitted); see also Matsushita, 475 U.S.
at 587; Ridgewood Bd. of Ed. v. Stokley, 172 F.3d 238, 252 (3d
Cir.

1999).

summary

In

deciding

judgment,

the

the

merits

court’s

role

of

a

party’s

is

not

to

motion

for

evaluate

the

evidence and decide the truth of the matter, but to determine
whether there is a genuine issue for trial. Anderson, 477 U.S.
at

249.

Credibility

determinations

are

the

province

of

the

factfinder. Big Apple BMW, Inc. v. BMW of N. Am., Inc., 974 F.2d
1358, 1363 (3d Cir. 1992).
There can be “no genuine issue as to any material fact,”
however,

if

a

party

fails

“to

make

a

showing

sufficient

to

establish the existence of an element essential to that party’s
11

case, and on which that party will bear the burden of proof at
trial.” Celotex, 477 U.S. at 322-23. “[A] complete failure of
proof concerning an essential element of the nonmoving party’s
case necessarily renders all other facts immaterial.” Id. at
323; Katz v. Aetna Cas. & Sur. Co., 972 F.2d 53, 55 n.5 (3d Cir.
1992).
II.

Failure to Warn
With

respect

to

argue

that

Defendants

Plaintiff’s
the

failure

learned

to

warn

intermediary

claim,
doctrine

precludes Plaintiff from suing them because the doctrine excuses
drug
these

manufacturers

from

manufacturers

warning

have

Plaintiff,

properly

and

individually,

adequately

prescribing physicians regarding Plavix’s risks.
sole

basis

Plaintiff’s
learned

for
failure

Defendants’
to

intermediary

warn

summary

claim

doctrine;

is

warned

notably,

defense
on

the

Indeed, the

judgment
the

when

motion

on

under

the

this

motion,

Defendants do not challenge Plaintiff’s position that Plavix’s
label is inadequate, and thus, this issue is not before me.
The California Supreme Court has held that manufacturers of
prescription drugs can be held strictly liable for failure to
warn of knowable risks. Brown v. Superior Court, 44 Cal. 3d
1049, 1069 (1988). Indeed, a manufacturer of prescription drugs
owes to the medical profession the duty of providing adequate
warnings if it knows, or has reason to know, of any dangerous
12

side

effects

of

its

drugs.

Carlin

v.

The

Superior

Sutter County, 13 Cal. 4th 1104, 1112-13 (1996).
strict

liability

require

a

plaintiff

to

prove

Court

of

"The rules of
only

that

the

defendant did not 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 distribution." Id. at 1112.

In

short, under California law, a plaintiff asserting a claim based
on a manufacturer's failure to warn must establish that (1) a
warning

was

absent

or

inadequate,

and

(2)

the

absence

or

inadequacy caused the plaintiff's injury. See Plummer v. Lederle
Labs., 819 F.2d 349, 358 (2d Cir. 1987) (applying California
law).
However, a pharmaceutical manufacturer does not have a duty
to warn the ultimate consumers of a drug’s potential dangers if
adequate warning has been given to physicians; this is the so
called learned intermediary doctrine. Carlin, 13 Cal. 4th at
1116. Importantly, “in the case of prescription drugs, the duty
to

warn

runs

to

the

physician,

not

to

the

patient."

Id.

(emphasis omitted); see Martin v. Merck & Co., Inc., No. 05-750,
2005 U.S. Dist. LEXIS 41232, at *9-10 (E.D. Cal. Aug. 15, 2005)
(noting that the learned intermediary doctrine is a defense to a
cognizable cause of action).

13

The

California

Court

of

Appeals

explained

the

rationale

behind the learned intermediary doctrine as follows:
(1) The doctor is intended to be an intervening party
in the full sense of the word. Medical ethics as well
as medical practice dictate independent judgment,
unaffected by the manufacturer's control, on the part
of the doctor. (2) Were the patient to be given the
complete and highly technical information on the
adverse possibility associated with the use of the
drug, he would have no way to evaluate it, and in his
limited understanding he might actually object to the
use of the drug, thereby jeopardizing his life. (3) It
would be virtually impossible for a manufacturer to
comply with the duty of direct warning, as there is no
sure way to reach the patient.
Carmichael v. Reitz, 17 Cal. App. 3d 958, 989 (1971) (citation
omitted).
Accordingly, “a manufacturer discharges its duty to warn if
it provides adequate warnings to the physician about any known
or

reasonably

knowable

dangerous

side

effects,

whether the warning reaches the patient.”

regardless

of

See Motus v. Pfizer,

Inc., 196 F. Supp. 2d 984, 990-91 (C.D. Cal. 2001).

It follows

that any failure to warn cannot be considered a proximate cause
of a subsequent injury to the consumer if the treating physician
was fully aware of the dangers that would have been included in
an alternative warning.

Id.

To overcome the learned intermediary doctrine on a summary
judgment motion, the plaintiff must present evidence to show
that the “non-disclosed risk was sufficiently high that it would
have changed the treating [or prescriber] physician's decision
14

to prescribe the product for the plaintiff." Motus, 196 F. Supp.
2d at 996 (quoting Thomas v. Hoffman-LaRoche, Inc., 949 F.2d
806, 815 (5th Cir. 1992) (discussing a plaintiff who suffered
seizures

after

inadequate

taking

warning

Accutane

caused

her

and

failed

injuries

to

prove

because

that

an

the

risk

of

seizures from Accutane is so low that it could not have affected
the

doctor's

decision

to

prescribe

the

medication))

(citing

Willett v. Baxter Int'l, Inc., 929 F.2d 1094, 1099 (5th Cir.
1991) (explaining it is unlikely that doctor would have changed
his

mind

to

implant

artificial

heart

valves

where

the

risk

undisclosed by the warnings – a .03 percent per annum rate of
failure due to soot pockets -- was minimal and “plaintiff failed
to present any specific evidence that this . . . risk would have
changed [the doctor's] decision”); Stanback v. Parke, Davis &
Co.,

657

F.2d

642,

645

(4th

Cir.

1981)

(explaining

that

plaintiff could not prove that manufacturer's failure to warn
that

its

resulted

flu

vaccine

in

her

manufacturer

had

could

contracting
provided

cause
the

Guillian-Barre

syndrome,

adequate

because

warnings,

a

Syndrome
even

if

reasonable

physician still would have administered the flu vaccine "despite
the slight risk" that plaintiff would contract GBS)). But see
Georges

v.

Novartis

Pharmaceuticals

Corp.,

No.

06-5207,

2012

U.S. Dist. LEXIS 189174, at *15-17 (C.D. Cal. Nov. 2, 2012)
(citing several district court cases involving Aredia and Zometa
15

denying summary judgment where the plaintiff provided evidence
that

the

physician
procedure);

treatment

would
In

have

re

changed

Aredia

&

a

prescription

Zometa

Products

or

Liab.

Litig., No. 06-1760, 2009 U.S. Dist. LEXIS 72098, at *7 (M.D.
Tenn.

Aug.

survive

13,

summary

treating

2009)

judgment

physicians

(applying

("[I]t

.

.

California

is

to
.

sufficient

show
would

law).

that
have

for

one

of

behaved

Importantly,

Plaintiff

to

[plaintiff's]
differently.")

in

the

case

of

prescription drugs, the duty to warn runs to the prescribing
physician.

Carlin, 13 Cal. 4th at 1116; Motus, 196 F. Supp. 2d

at 990.
Indeed, nationally, it is well-settled that in prescription
drug

failure-to-warn

cases,

courts

apply

this

doctrine.

See,

e.g., Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 816 (11th
Cir. 2010) (concluding that summary judgment was proper where
the

“doctor

even

when

provided
provided

explicit,
with

the

uncontroverted
most

current

testimony

research

that,

and

mandated warnings, he still would have prescribed [the drug]
. . .

FDA
.

Pursuant to Georgia's learned intermediary doctrine, this

assertion severs any potential chain of causation”); Ebel v. Eli
Lilly

&

summary

Co.,

536

judgment

F.Supp.
for

2d

767

defendant

(S.D.

upon

Tex.

finding

2008)
that

(granting

prescribing

physician was aware of Zyprexa's suicide-related risks that an
adequate

warning

would

have

provided
16

and

that

plaintiff

had

presented

no

evidence

physician

would

not

have

prescribed

Zyprexa had defendant provided him with an alternate warning
label), aff'd, 321 Fed. App'x 350 (5th Cir. 2009) (per curiam);
Allgood v. GlaxoSmithKline PLC, No. 06-3506, 2008 U.S. Dist.
LEXIS 12500, at *10, *18 (E.D. La. Feb. 20, 2008) (granting
summary judgment to defendant because plaintiff had failed to
show (1) that defendant did not adequately warn the physician of
a risk associated with the drug that was not otherwise known to
the physician and (2) that the "failure to warn the physician
was

both

a

plaintiffs’

cause

in

injury"),

fact
aff'd

and
sub

the
nom.

proximate
Allgood

cause
v.

of

the

SmithKline

Beecham Corp., 314 Fed. App'x 701 (5th Cir. 2009) (per curiam).
Here,

there

is

no

dispute

that

both

Drs.

Bahreman

and

Leonard testified — at their deposition — that even considering
the bleeding risks and the additional warnings, they would have
prescribed

Plavix

to

Plaintiff

in

light

of

various

medical

factors in connection with Plaintiff’s condition, particularly
the fact that Plaintiff might have been intolerant of aspirin.
On this motion, however, Plaintiff’s opposition focuses solely
on a declaration Dr. Bahreman supplied to Plaintiff’s counsel
after the doctor’s deposition and after Defendants filed their
summary judgment motion. Plaintiff points out that Dr. Bahreman
indicated in his declaration that after having reviewed the Chan

17

Study in greater detail, 4 the doctor opined that Plavix should
have included a warning about the risk of recurrent bleeding
ulcers associated with Plavix and a placebo over aspirin and a
proton pump inhibitor.
information,
regarding

Dr.

Plaintiff argues that, based on that

Bahreman

Plaintiff’s

would

Plavix

have

changed

prescription.

his

In

decision

that

regard,

Plaintiff could only survive summary judgement if Dr. Bahreman’s
post-deposition

declaration

is

issue on summary judgment.

sufficient

to

raise

a

triable

I do not so find for the reasons

below.
First, as a threshold matter, the parties do not center
their arguments on the following dispositive issue: whether Dr.
Bahreman was the physician who prescribed Plavix to Plaintiff
during

the

bleeding

in

relevant
November

time

period

2011.

To

that

led

be

clear,

to

Plaintiff’s

in

the

case

GI
of

prescription drugs, under California law, the duty to warn only
applies to the prescribing physician.

Carlin, 13 Cal. 4th at

1116; Motus, 196 F. Supp. 2d at 990.

As explained above, Dr.

Bahreman was the neurologist who treated Plaintiff during her
Generally, the Chan Study, entitled Clopidogrel versus
Aspirin and Esomeprazole to Prevent Recurrent Ulcer Bleeding,
concluded Plavix is not as safe or superior on the stomach than
aspirin plus esomeprazole (the generic name for an inexpensive
over-the-counter proton pump inhibitor such as Prilosec), in
light of the Study's findings that recurring stomach bleeding
was 8.6% in the Plavix group versus only .7% in the aspirin
group. See Begley v. Bristol-Myers Squibb Co., No. 06-6051, 2009
U.S. Dist. LEXIS 121058, at *11-12 (D.N.J. Dec. 30, 2009).
4

18

September

2011

hospitalization,

and

although

Dr.

Bahreman

administered the initial dose of Plavix to Plaintiff during that
time,

with

regard

to

the

decision

of

prescribing

Plavix

to

Plaintiff, Dr. Bahreman explicitly testified that it would be
the

determination

Leonard,

to

of

place

Plaintiff’s

Plaintiff

primary

on

any

care

physician,

prescription

Dr.

after

Plaintiff was discharged:
Q: And whose decision would it be — when in a
situation like this where Dr. Leonard’s patient is in
the hospital and she is asking you for a consult, and
then you give you neurological consult and then the
patient is discharged, whose decision is it to
prescribe particular medications on discharge.
A:

Primary care physician.

Q:

Okay.

A:

Dr. Leonard.

Q:
You give your input, and then it’s up to her to
make the decision?
A:

Absolutely.

Dr. Bahreman’s Dep., T112:12-25.
in

this

regard

is

Thus, Dr. Bahreman’s testimony

unequivocal

—

that

in

Plaintiff’s

circumstance, Dr. Leonard was the prescribing physician.
While Dr. Leonard testified that she rarely initiates any
prescription when a patient is being treated by a specialist,
she,

nonetheless,

Plaintiff
hospital.

at

the
See

made

the

time
Dr.

decision

prescribe

Plavix

was

discharged

from

Dep.,

T56:20-23.

Plaintiff

Leonard’s
19

to

to
the

Indeed,

Plaintiff’s discharge summary makes it clear that Dr. Leonard
made the independent medical decision to prescribe Plavix.
Discharge Summary, p. 1.

See

In that Summary, Dr. Leonard noted

that Dr. Bahreman indicated that he would like Plaintiff to be
placed on Plavix, and that Dr. Leonard, herself, concurred with
that

determination,

intolerant

of

Plaintiff

because

aspirin.

was

hospitalization,

Plaintiff

See

id.

discharged
Dr.

Leonard

inter

Ultimately,

from
faxed

was,

her

the

September

Plaintiff’s

including Plavix, to a pharmacy. See id.

at

alia,
time
2011

prescriptions,

Subsequently, and most

importantly, Plaintiff suffered GI bleeding in November 2011,
when Plaintiff was on the prescription given by Dr. Leonard.
In that regard, based on the testimony of both doctors and
documentary evidence, I find that although Dr. Leonard consulted
with

Dr.

Bahreman

and

other

doctors

regarding

Plaintiff’s

condition and on which type of medications should prescribed to
Plaintiff,

Dr.

Leonard

was

prescribing

physician,

who

benefits

of

placing

bleeding

risks

that

the

decision-maker,

ultimately

Plaintiff
she

final

on

posed.

determined

Plavix
Thus,

far
for

or

the

that

the

outweighed

the

the

purposes

of

applying the learned intermediary doctrine, the relevant inquiry
should be focused on whether Dr. Leonard was sufficiently warned
by Defendants regarding the risks of Plavix, and whether Dr.
Leonard would, in any event, have prescribed Plavix to Plaintiff
20

in light of additional warnings proposed by Plaintiff.

Indeed,

as to both of these questions, Dr. Leonard testified in the
affirmative.

Accordingly, based on this reason alone, I reject

Plaintiff’s 11th-hour submission of Dr. Bahreman’s declaration
obtained after his deposition, for the purposes of defeating
summary judgment.
Next, even considering Dr. Bahreman’s declaration, I still
find summary judgment appropriate.

To defeat summary judgment,

Plaintiff attempts to use Dr. Bahreman’s declaration to clarify
his testimony regarding the Chan study during his deposition.
On that topic, Dr. Bahreman, at first, testified that he did not
remember reviewing such a study in 2011, or that he was aware of
the conclusions of the Chan study.
T90:10-T91:9.

See Dr. Bahreman’s Dep.,

However, the doctor, at his deposition, was read

the results of the study, and when questioned whether knowing
those results would change his mind about administering Plavix
to Plaintiff, he responded:
A: . . . It might be this study confirm also this
general kind of agreement that we have as neurologist
just having intolerance is not enough to disqualify
patients from aspirin or Plavix. So – but [the Chang
study] is another . . . study which confirmed our
general opinion, if I’m not mistaken.
* * *
Q: Okay. If you had been aware of such a study
existing, would you consider this in any way relevant
to your clinical practice?

21

A:
At this point, no.
Of course, every study,
everything, there is a point for all of us, of course
we are learning, of course.
But if you think that I
am going to change my opinion about Plavix at this
point, no, I won’t.
Again,
just
know
that
intolerance
topics,
intolerance, bleeding ulcers in the patient who had a
history of bleeding in the past, those are the things
that we are putting them in the equation. There are a
lot of patients having no problem whatsoever, GI
problems, with the Plavix or aspirin.
So it doesn’t
change our opinion about using either of them. In the
future or the like currently.
If we have a patient with a GI bleed, we have to
be cautious.
We know that.
We have to be cautious
for both [aspirin and Plavix.]
And if I have an
allergy – a patient with allergy, definitely my
threshold for using Plavix is much lower than having
intolerance about aspirin.
Id. at T92:10-15; T96:14-T97:16.
In

his

post-deposition

declaration,

Dr.

Bahreman

states

that “[a]t the time Ms. Thorpe was prescribed Plavix, it was my
belief

that

Plavix

was

not

more

dangerous

than

aspirin

for

patients that had a documented gastrointestinal intolerance of
aspirin.”
states

Dr.

that

Bahreman’s

he

was

not

Dec.,

¶

6.

aware

of

the

Dr.

Bahreman

Chan

study

further
or

its

conclusions that patients with a history of bleeding ulcers were
much

less

likely

to

suffer

recurrent

bleeding

aspirin plus a PPI rather than Plavix alone.

when

taking

Id. at ¶ 8.

But,

significantly, the doctor explains that it was his belief that
had

Plavix

labeling

included

the

Chan

study,

he

would

have

“shared” that information, and Plaintiff “would not have been
prescribed Plavix.”

Id. at ¶ 9.
22

Thus, placed in that context,

it appears that Dr. Bahreman is declaring that he would have
shared the information regarding the Chan study presumably with
Dr. Leonard, and he surmises, post hoc, that Plaintiff would not
have been given Plavix — by Dr. Leonard — to treat her medical
condition.

Indeed,

that

statement

is

consistent

with

Dr.

Bahreman’s prior testimony that he only provided input to Dr.
Leonard

as

to

the

types

of

prescription

Plaintiff

given, not that he was the ultimate prescriber.
because

Dr.

Bahreman

was

not

the

should

be

It follows that

prescriber

that

led

to

Plaintiff’s bleeding episode, his statement regarding whether a
different warning would have changed his input or consultation
with the prescriber, cannot raise a genuine issue of material
fact on the learned intermediary analysis.
Instead, as I have already explained, Dr. Leonard’s medical
determinations
opinions

are

regarding

relevant
the

in

Chang

this

regard,

study,

the

Plaintiff relies to defeat summary judgment.
deposition,

counsel

questioned

whether

it

particularly
basis

upon

her

which

At Dr. Leonard’s
was

the

doctor’s

opinion, in the context of the Chan study, that “there was a
higher rate of ulcer bleeding with clopidogrel [Plavix] than
with

the

aspirin

and

the

Leonard’s Dep., T44:18-23.

esomeprazole

[PPI]

group.”

Dr.

Criticizing the design of the study,

Dr. Leonard responded, “No, because it is not comparing apples
to apples.

I mean, it seems to me that one should have the
23

clopidogrel
compare.”

with

the

esomeprazole,

rather

than

a

placebo

to

Id. at T25:25-T26:3. Moreover, when asked whether

patients with ulcer bleeding should not be given Plavix instead
of aspirin, Dr. Leonard explained:
A: Well, its saying that patients who have had
bleeding from aspirin in the past – which is the group
they studied, which doesn’t apply to my patient
[Plaintiff], but – they should not be given the
clopidogrel is what it’s saying.
It doesn’t explain – I mean, it needs more
testing is what it is. Would it make any difference?
That’s why I’m saying, I don’t know if there are other
studies that show that aspirin versus clopidogrel with
and without a PPI has any differences.
I just don’t
know that data.
Id.

at

whether

T45:18-T46:3.
the

Chan

More

study

importantly,

would

have

when

changed

further
her

asked

prescribing

decision in November 2011, Dr. Leonard stressed: “No, because
this didn’t apply to my patient.”
In

short,

fatal

to

Id. at T47:10-11.

Plaintiff’s

position,

Dr.

Leonard

testified unequivocally that the Chan study was irrelevant to
her prescribing decision because that study did not apply to
Plaintiff’s medical circumstances, and because its study design
did not compare “apples to apples.”
T47:7-11, T44:25-T45:3. 5

See Dr. Leonard’s Dep.,

Hence, Plaintiff’s submission of Dr.

5

Because Dr. Leonard testified that the Chan study would not
have changed her decision, I need not discuss in detail
Plaintiff’s argument that the conclusions made by the Chan study
squarely apply in Plaintiff’s circumstances.
But, I note that
the Chan study only involved patients who presented with active
ulcer bleeding, whereas, Plaintiff was known to have a past
24

Bahreman’s declaration fails to defeat summary judgment, because
Dr. Bahreman’s speculative statement regarding what Dr. Leonard
would have concluded is insufficient to raise any doubt as to
Dr. Leonard’s testimony, such that an issue of fact would exist.
In sum, Plaintiff has failed to point to any evidence to
meet her burden of proving causation.

Plaintiff must show, on

this

decision;

motion,

Leonard

has

a

changed

testified

prescription

that

she

knew

full

however,

well

that

Dr.

Plavix

increases bleeding risk and that Plaintiff was at a high risk of
bleeding

given

factors.

In

her
light

past
of

history

that

of

ulcers

unambiguous

and

other

testimony,

risk

Plaintiff

simply has not produced any evidence to controvert Dr. Leonard’s
statements;
different

put

differently,

prescription

Leonard

were

Plavix’s

bleeding

Plaintiff

decision

presented
risk,

would

with
i.e.,

has
have

additional
the

Chan

not
been

shown
made

information

study.

that
if

a

Dr.

about

Indeed,

Dr.

Leonard addressed the Chan study in her deposition and explained
why she found the study not to have any impact on her decision
to

prescribe

Plavix

to

Plaintiff.

Accordingly,

because

Plaintiff fails to raise a genuine issue of material fact on
causation, her failure to warn claims (Counts I and III) are

history of ulcers, which condition occurred more than ten years
before her prescription.
As such, it is a tenuous comparison
between Plaintiff’s situation and the study’s results from
patients with active bleeding ulcers.
25

dismissed,

and

Defendants’

motion

for

summary

judgment

is

granted in this regard.
III. Remainder of Plaintiff’s Claims
In her Complaint, Plaintiff also asserts claims of design
defect (Count I), manufacturing defect (Count II) and negligence
(IV). 6

As to the negligence claim, Plaintiff does not dispute

that her allegations of negligence merely restate the averments
made on her failure to warn claim.
is

dismissed

for

the

same

Thus, the negligence claim

reasons

sustain her failure to warn claim.

why

Plaintiff

failed

to

See Motus, 196 F. Supp. 2d

at 999 (granting summary judgment on a failure to warn claim and
then

dismissing

the

negligence

claim

because

that

claim

was

premised on the same allegations that the defendants failed to
adequately warn of the risk of a drug).
Similarly, Plaintiff’s manufacturing defect claim is also
dismissed,

because

Plaintiff

presents

6

no

evidence

that

the

Thorpe’s claims are part of a multi-plaintiff complaint,
wherein the Complaint asserts additional claims for loss of
consortium and wrongful death. As to this particular plaintiff,
because there is no allegation that Thorpe is deceased, the
wrongful
death
claim
clearly
does
not
apply,
here.
Additionally, there is no indication that Thorpe is pursuing a
loss of consortium claim. Even if she were, because all of her
causes of action are dismissed on this summary judgment motion,
the lost consortium claim would correspondingly be dismissed.
See Thomsen v. Sacramento Metro. Fire Dist., No. 09-01108, 2009
U.S. Dist. LEXIS 97242, at *39 (E.D. Cal. Oct. 20, 2009)(finding
that under California law, a claim for loss of consortium does
not stand on its own, but is recognized as a derivative of other
injuries not an injury in and of itself).
26

Plavix

she

used

differed

from

the

manufacturer’s

result, which is a required element of that claim.

intended
Barker v.

Lull Eng’g Co., 20 Cal. 3d 413, 429 (1978) ( “a manufacturing or
production defect is readily identifiable because a defective
product is one that differs from the manufacturer's intended
result

or

product

from

other

line.”).

ostensibly

Therefore,

identical

Plaintiff’s

units

of

the

manufacturing

same

defect

claim is dismissed.
Finally, summary judgment as to Plaintiff’s design defect
claim

is

appropriate.

I

note

that

in

her

briefing,

while

Plaintiff opposes the dismissal of this particular claim, she,
nevertheless, does not make any substantive argument as to why
her design defect claim should proceed if her failure to warn
claim is dismissed.

Indeed, California courts have carved out

an “exception” to strict manufacturing liability when it comes
to prescription drugs. Artiglio v. Superior Court, 22 Cal. App.
4th

1388,

1392

(1994).

In

Brown

v.

Superior

Court,

the

California Supreme Court concluded that “a drug manufacturer’s
liability for a defectively designed drug should not be measured
by

the

standards

"appropriate

test

of
for

strict

liability"

determining

but,

responsibility

rather,
is

the

the
test

stated in comment k [to section 402A of the Restatement Second
of Torts ("Comment k")]." 44 Cal. 3d 1049, 1061 (1988) (basing
its

conclusion,

in

part,

on

"the
27

public

interest

in

the

development, availability, and reasonable price of drugs"). In
that

regard,

Brown

established

that

"a

manufacturer

is

not

strictly liable for injuries caused by a prescription drug so
long

as

the

drug

was

properly

prepared

and

accompanied

by

warnings of its dangerous propensities that were either known or
reasonably scientifically knowable at the time of distribution."
44 Cal. 3d at 1069.
drugs

set

forth

manufacturers
defects,

in

remain

negligence,

Despite the exception for prescription
Brown,

the

subject
and

for

to

Court

made

liability

failure

clear
for

to

warn

that

drug

manufacturing
of

known

or

reasonably knowable side effects. Id. at 1069 n.12.
Here,

under

California

law,

Plaintiff

cannot

pursue

a

design defect claim when her failure to warn claim has been
dismissed, and she has failed to demonstrate that Plavix was not
accompanied

by

a

proper

warning.

As

I

stated

earlier,

Plaintiff, in her opposition, has not cited to any evidence, or
made any arguments, as to why summary judgment should be denied
on her design defect claim, effectively abandoning such a claim
in that respect.

See, e.g., Angle v. United States, No. 12-

2495, 2012 U.S. Dist. LEXIS 181686, at *8-9 (D.N.J. Dec. 21,
2012); Oticon, Inc. v. Sebotek Hearing Sys., LLC, 865 F. Supp.
2d

501,

508

n.5

(D.N.J.

2011).

Moreover,

the

Court,

independently, cannot find any basis to deny summary judgment on
this claim, and therefore, it is dismissed.
28

CONCLUSION
For
summary

the

reasons

judgment

expressed

is

GRANTED.

above,

Defendants’

Plaintiff’s

motion

Complaint

for
is,

therefore, dismissed.

DATED:

October 26, 2017

/s/ Freda L. Wolfson
Freda L. Wolfson
United States District Judge

29