BEGLEY v. BRISTOL-MYERS SQUIBB COMPANY et al

Filing 111

OPINION filed. Signed by Judge Freda L. Wolfson on 1/11/2013. (mmh)

*NOT FOR PUBLICATION*
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
______________________________
PATRICIA BEGLEY,

:
Civil Action No. 06-6051(FLW)

Plaintiff,

:

v.
:
BRISTOL-MYERS SQUIBB CO.,
et al.,

OPINION

:

Defendants.
:
______________________________
WOLFSON, District Judge:
Plaintiff Patricia Begley (“Plaintiff” or “Mrs. Begley”)
brings the instant suit against Defendants, Bristol Myers-Squibb
Company
U.S.,

(“BMS”),
Inc.,

“Defendants”),
of

Defendants’

Sanofi-Aventis

and

U.S.,

L.L.C.,

Sanofi-Aventis

Inc.

(collectively,

Sanofi-Synthelabo,

alleging that she suffered injuries as a result
design,

development,

manufacture,

testing,

packaging, promoting, marketing, distributing, labeling and sale
of their prescription drug Plavix, an anti-clotting medication.
Plaintiff’s

Amended

Complaint

(“Amended

Complaint”)

asserts

various Illinois state and common law claims against Defendants,
including

Failure-to-Warn,

Defective

1

Design,

Manufacturing

Defect and Negligence.1

Before the Court is Defendants’ motion

for summary judgment based upon a number of theories, including
the learned intermediary doctrine under Illinois law.

For the

reasons that follow, Defendants’ motion for summary judgment is
GRANTED and all counts in the Amended Complaint are dismissed.2
BACKGROUND3
A.

Plavix
Plavix is a drug that inhibits blood platelets from forming

1

In
her
Original
Complaint,
Plaintiff
initially
asserted New Jersey state and common law claims against
Defendants.
Following two separate decisions rendered by the
New Jersey Supreme Court in 2007, Plaintiff voluntarily
dismissed those New Jersey claims and amended her Complaint to
assert causes of action arising only under Illinois state law.
See Opinion dated December 30, 2009, pp. 2-3.
Therefore,
Illinois law controls on this motion.
2

Pending before this Court are related cases filed by
other plaintiffs who were allegedly injured by ingesting Plavix,
albeit their injuries may be different than those suffered by
Ms. Begley in this case.
In those related cases, Defendants
have also filed summary judgment motions.
Moreover, the Court
is aware that there are numerous cases concerning Plavix brought
against Defendants in other state and federal courts across the
country.
Because each plaintiff’s personal circumstances
differ, the Court’s findings in this Opinion only represent the
application of pertinent state law, i.e., Illinois, to the facts
presented in this particular case.
That said, to avoid
unnecessary duplication of effort in my several related cases
and to conserve judicial resources, I cite to the analysis of
similar legal issues in my published opinion in Solomon v. BMS,
Civil Action No. 07-1102 (FLW) (Slip Op.), where appropriate.
3

The following facts are undisputed unless otherwise

noted.
2

clots.

The drug was initially approved by the United States

Food and Drug Administration (“FDA”) for use as monotherapy,
i.e., taken without another drug, in patients with recent heart
attack,

stroke,

or

(“PVD”).

See

Defs.

approved

Plavix

for

diagnosed

peripheral

Statement,

¶

dual

therapy

vascular

2.

Thereafter,

with

aspirin,

disease
the

which

FDA
also

contains antiplatelet effects, in the treatment of patients with
particular types of acute coronary syndrome (“ACS”).4

Id. at ¶

3.
Taking Plavix is not without risk.

Because it functions by

inhibiting the formation of blood clots, Plavix increases the
risk of bleeding.

In that connection, when Plavix entered the

market, labeling on Plavix included certain information on that
risk.

The label provides:
PRECAUTIONS
General
As with other antiplatelet agents, PLAVIX should be
used with caution in patients who may be at risk of
increased bleeding from trauma, surgery, or other
pathological conditions.
If a patient is to undergo
4

ACS is a set of clinical signs and symptoms occurring
when the heart muscle does not receive enough blood because of
plaque narrowing or blocking of the arteries leading to the
heart.
Commonly, ACS includes, inter alia, heart attacks and
irregular chest pains known as unstable angina.
See, e.g.,
Frederick G. Kushner, et al., 2009 Focused Updates: ACC/AHA
Guidelines for the Management of Patients with ST-Elevation
Myocardial Infraction and Guidelines on Percutaneous Coronary
Intervention, 54 J. Am. C. Cardiology 2205, 2212 (2009).
3

elective surgery and an antiplatelet effect is not
desired, PLAVIX should be discontinued 5 days prior to
surgery.
GI Bleeding: PLAVIX prolongs the bleeding time.
In
CAPRIE5, PLAVIX was associated with a rate of
gastrointestinal bleeding of 2.0% vs. 2.7% on aspirin.
In CURE, the incidence of major gastrointestinal
bleeding was 1.3% vs. 0.7% (PLAVIX + aspirin vs.
placebo + aspirin, respectively).
PLAVIX should be
used with caution in patients who have lesions with a
propensity to bleed (such as ulcers).
Drugs that
might induce such lesions should be used with caution
in patients taking PLAVIX.
* * *
Information for Patients
Patients should be told that it may take them longer
than usual to stop bleeding when they take PLAVIX, and
that they should report any unusual bleeding to their
physician.
* * *
ADVERSE REACTIONS
Hemorrhagic: In CAPRIE patients receiving PLAVIX,
gastrointestinal hemorrhage occurred at a rate of
2.0%, and required hospitalization in 0.7%.
In
patients receiving aspirin, the corresponding rates
were 2.7% and 1.1%, respectively.
The incidence of
intracranial hemorrhage was 0.4% for PLAVIX compared
to 0.5% for aspirin.

5

According to BMS, the clinical evidence for the risks
of PLAVIX is derived from two double-blind trials: (i) the
CAPRIE study (Clopidogrel v. Aspirin in Patients at Risk of
Ischemic Events), a comparison of PLAVIX to aspirin, and (ii)
the CURE study (Clopidogrel in Unstable Angina to Prevent
Recurrent Ischemic Events), a comparison of PLAVIX to placebo,
both given in combination with aspirin and other standard
therapy.
See February 2002 Plavix Labeling, p.3.
While
Plaintiff contests the accuracy of these clinical trials, its
arguments are not relevant to my disposition of this case. They
are addressed in detail, however, in my opinion in Solomon.
4

In CURE, PLAVIX use with aspirin was associated with
an increase in bleeding compared to placebo with
aspirin (see Table 3)6. There was an excess in major
bleeding in patients receiving PLAVIX plus aspirin
compared
with
placebo
plus
aspirin,
primarily
gastrointestinal and at puncture sites. The incidence
of intracranial hemorrhage (0.1%), and fatal bleeding
(0.2%), was the same in both groups.
See, generally, February 2002 Plavix Labeling.
B.

Plaintiff’s Medical History
Plaintiff Patricia Begley has a history of coronary artery

disease and acute coronary syndrome.

In December of 2003, she

presented to the emergency room at Sherman Hospital in Elgin,
Illinois

with

chest

discharge summary).
likely

suffered

a

pain.

Shah

Cert.,

Exh.

43

(12/31/2003

It was subsequently determined that she had
heart

attack,

id.,

Exh.

44

(Catherization

Report), and that she suffered from severe stenosis - a 76 to 90
percent blockage of her arteries, Nisar Dep. 67:9-22.

While she

was hospitalized, interventionalist Dr. Asim Nisar, M.D., served
as her treating cardiologist.

He implanted two stents in her

arteries in order to remedy blockages.

Nisar Dep. 76:14-23.

After implanting the stents, Dr. Nisar placed Plaintiff on dual
therapy, specifically, 325 mg of aspirin and 75 mg of Plavix
each day, in order to prevent "what's called stent thrombosis, .

6

Table 3 of the labeling includes certain “incidence of

bleeding.”
5

. . . meaning clotting of the stent."

Id. at 71:2-73:21.

Once Plaintiff was discharged, she saw Dr. Farzana Hosain
for follow-up care through January 2006.
Plaintiff’s dual therapy.
Dr.

Hosain’s

hemorrhoids
2006.

in

care,
2004

Hosain Dep. 83:15-22.

Plaintiff
and

Dr. Hosain continued

experienced

While under

bleeding

gastrointestinal-related

bleeding

Id. at 67:11-68:1; 84:18-85:8; 93:18-94:23.

ceased taking Plavix on January 12, 2006.
143:1.

from
in

Plaintiff

Begley Dep. 142:23-

Altogether, Plaintiff was on dual therapy for a period

of several years.
C.

Plaintiff’s Amended Complaint
Due to the gastrointestinal bleeding allegedly resulting

from taking Plavix, Plaintiff brings the instant suit against
Defendants asserting product liability related causes of action
for defective design, manufacturing defect, failure to warn, and
negligence under the Illinois law.
Count IV.7

See Am. Compl., Count I -

Although these claims are characterized differently,

they essentially turn on whether Defendants adequately warned
that Plavix carried a risk of bleeding complications.

In that

regard,

learned

7

claims

on

this

motion,

Defendants

argue

that

the

On December 30, 2009, this Court dismissed Plaintiff’s
for negligent misrepresentation (Count V) and for
6

intermediary
because

the

doctrine
doctrine

precludes
excuses

Plaintiff

drug

from

manufacturers

suing
from

them

warning

Plaintiff, individually, when these manufacturers have properly
and

adequately

warned

the

prescribing

physicians

regarding

Plavix’s risks.
DISCUSSION
I.

Standard of Review
Summary judgment is “proper if there is no genuine issue of

material

fact

and

if,

viewing

the

facts

in

the

light

most

favorable to the non-moving party, the moving party is entitled
to judgment as a matter of law."

Pearson v. Component Tech.

Corp., 247 F.3d 471, 482 n. 1 (3d Cir.2001) (citing Celotex
Corp. v. Catrett, 477 U.S. 317, 322 (1986)); accord Fed. R. Civ.
P.

56(c).

For

an

issue

to

be

genuine,

there

must

be

"a

sufficient evidentiary basis on which a reasonable jury could
find for the non-moving party."

Kaucher v. County of Bucks, 455

F.3d 418, 423 (3d Cir.2006); Anderson v. Liberty Lobby, Inc.,
477 U.S. 242, 248 (1986).

In determining whether a genuine

issue of material fact exists, the court must view the facts and
all reasonable inferences drawn from those facts in the light
most favorable to the nonmoving party.

Matsushita Elec. Indus.

violation of the Illinois Deceptive Trade Practices Act (Count
7

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

For a fact to be

material, it must have the ability to "affect the outcome of the
suit under governing law."

Kaucher, 455 F.3d at 423.

Disputes

over irrelevant or unnecessary facts will not preclude a grant
of summary judgment.
Initially, the moving party has the burden of demonstrating
the absence of a genuine issue of material fact.

Celotex Corp.,

477 U.S. at 323.

Once the moving party has met this burden, the

nonmoving

must

party

identify,

by

affidavits

or

otherwise,

specific facts showing that there is a genuine issue for trial.
Id.; Maidenbaum v. Bally's Park Place, Inc., 870 F.Supp. 1254,
1258

(D.N.J.1994).

Thus,

to

withstand

a

properly

supported

motion for summary judgment, the nonmoving party must identify
specific facts and affirmative evidence that contradict those
offered by the moving party.

Anderson, 477 U.S. at 256-57. "A

nonmoving party may not ‘rest upon mere allegations, general
denials or ... vague statements...'"

Trap Rock Indus., Inc. v.

Local 825, Int'l Union of Operating Eng'rs., 982 F.2d 884, 890
(3d Cir. 1992) (quoting Quiroga v. Hasbro, Inc., 934 F.2d 497,
500

VI).

(3d

Cir.

1991)).

Moreover,

the

See Order dated December 30, 2009.
8

non-moving

party

must

present "more than a scintilla of evidence showing that there is
a genuine issue for trial."

Woloszyn v. County of Lawrence, 396

F.3d 314, 319 (3d Cir. 2005). Indeed, the plain language of Rule
56(c) mandates the entry of summary judgment, after adequate
time for discovery and upon motion, against a party who fails to
make

a

showing

sufficient

to

establish

the

existence

of

an

element essential to that party's case, and on which that party
will bear the burden of proof at trial. Celotex Corp., 477 U.S.
at 322.
Moreover, in deciding the merits of a party's motion for
summary

judgment,

the

court's

role

is

not

to

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 fact

finder.

Big Apple BMW, Inc. v. BMW of N. Am., Inc., 974 F.2d

1358, 1363 (3d Cir. 1992).
II.

Illinois Failure-to-Warn Claim
Under Illinois law, a plaintiff must prove the following

elements in order to succeed on a failure to warn claim against
a prescription drug manufacturer: (1) that there was a duty to
warn; (2) the manufacturer knew or should have known that the
drug

could

cause

the

adverse
9

reaction

experienced

by

the

plaintiff; (3) the manufacturer failed to warn about the drug’s
potential

reaction;(4)

omission

of

this

information

made

the

warning inadequate and the drug defective; and (5) this defect
proximately caused the plaintiff’s injuries.
v.

Upjohn

Co.,

572

N.E.2d

1030,

1037

Northern Trust Co.

(Ill.

App.

Ct.

1991);

Langer v. Dista Products Co., Div. of Eli Lilly and Co., Civil
Action No. 90 C 4598, 1996 WL 526763, at *2 (N.D. Ill. Sept. 12,
1996).
Plaintiff argues here that Defendants failed to adequately
warn Plaintiff and her prescribing physicians of the potential
for

bleeding

complications

from

taking

Plavix.

More

specifically, Plaintiff insists that her prescribing physicians
were not warned regarding Plavix’s propensity to cause strokes,
heart attacks, abnormal bleeding and “other serious issues and
side effects.”

Am. Compl., ¶ 53.

The parties agree that the

legal sufficiency of Plaintiff’s failure to warn claim rests on
my application of Illinois’ learned intermediary doctrine; thus,
to that doctrine I now turn.
A.

Illinois’ Learned Intermediary Doctrine

Illinois

courts

have

adopted

the

“learned

intermediary”

doctrine, which provides that the manufacturers of prescription
drugs

need

not

warn

patients
10

directly,

but

must

“warn

prescribing physicians . . . of the product's known dangerous
propensities.”

Hansen v. Baxter Healthcare Corp., 764 N.E.2d

35, 42 (Ill. 2002) (citing Kirk v. Michael Reese Hosp. & Med.
Ctr., 513 N.E.2d 387, 392 (1987)).

Those physicians, in turn,

“have a duty to convey the warnings to their patients.”
The

adequacy

of

the

warning

“must

be

judged

by

whether

Id.
it

sufficiently apprises physicians of the risks associated with
the

use”

Corp.,

of

958

the

medical

N.E.2d

447,

because

“[t]he

between

the

doctor,

device.
455

(Ill.

functioning

prescription

drug

See

Hernandez

App.

Ct.

as

a

2011).

learned

manufacturer

v.

and

Schering
This

is

intermediary
the

patient,

decides which available drug best fits the patient's needs and
chooses which facts from the various warnings should be conveyed
to the patient ....”

Tongate v. Wyeth Laboratories, a Div. of

American Home Products Corp., 580 N.E.2d 1220, 1225 (Ill. Ct.
App. 1991) (citing Kirk, 513 N.E.2d at 393).
disclosure is a matter of medical judgment.”

“[T]he extent of
Id.

As a corollary to the learned intermediary doctrine, drug
manufacturers are not obligated to warn prescribing physicians
of risks already known to the medical community, see Hansen, 764
N.E.2d at 42 (citation omitted), because “there is no duty to
warn of a risk that is already known by those to be warned,”
11

Proctor v. Davis, 682 N.E.2d 1203, 1211 (Ill. Ct. App. 1997)
(citing Kokoyachuk v. Aeroquip Corp., 526 N.E.2d 607 (1988)).
In

Illinois,

‘unequal

“[a]

duty

knowledge

to

and

warn

the

exists

only

defendant,

when

possessed

there
of

is

such

knowledge, knows or should know that harm might occur if no
warning is given.’”

Id.

(quoting Kokoyachuk, 526 N.E.2d at

610).
Because

“[o]nly

a

physician

or

someone

with

specialized

knowledge would be qualified to determine whether the warning
was inadequate,” a plaintiff must present expert testimony to
establish that a warning is inadequate.

Hernandez, 958 N.E.2d

at 455–56; N. Trust Co. v. Upjohn Co., 572 N.E.2d 1030, 1036
(Ill. App. Ct. 1991).

See also Sosnowski v. Wright Medical

Technology, Inc., Civil Action No. 11 C 59, 2012 WL 1030485, at
*7

(N.D.Ill.

Inc.,

151

Mar.

27,

F.Supp.2d

2012);
952,

Erickson

962-63

v.

Baxter

(N.D.Ill.

Healthcare,

2001).

Expert

testimony is not required, however, where the inadequacy of the
warning

is

so

obvious

that

a

lay

person

understand the insufficiency of the warning.”

could

“readily

N. Trust Co., 572

N.E.2d at 1036.
With regard to causation, that question is “for the jury to
decide unless, viewing the facts in the light most favorable to
12

[the non-moving party] no jury could reasonably conclude that
the

defendants'

conduct

injuries or death.”

was

a

cause

of

[the

plaintiff’s]

Erickson, 151 F.Supp.2d at 967 (quoting

Thacker v. UNR Indus., Inc., 603 N.E.2d 449, 455 (Ill. 1992)).
See also Baltus v. Weaver Division of Kidde & Co., 557 N.E.2d
580 (Ill. 1990) ("[T]he simple statement that proximate cause is
for the jury to decide does not substitute for an affirmative
factual base from which to infer such proximate cause.")
In

determining

whether

a

plaintiff

has

demonstrated

proximate cause, courts applying Illinois law look carefully at
the testimony of the prescribing physician.

Summary judgment

may

the

be

granted

on

causation

grounds

“when

physician’s

testimony shows unequivocally that s/he knew at the relevant
time all the information which would have been included in a
proper warning.”
1063,

1067

See also Giles v. Wyeth, Inc., 500 F.Supp.2d

(S.D.Ill.

2007)

(emphasis

in

original).

Accord

Stephens v. Hook-SuperX, 359 Fed.Appx. 648, 650 (7th Cir. 2009)
(affirming grant of summary judgment where there was “no genuine
dispute that [the doctor] knew [of the] potential side effect .
.

.

when

denied

she

summary

prescribed
judgment

the

drug.”).

where

the

Illinois

courts

prescribing

have

physician

testified that he was not aware that the drug could cause the
13

adverse

reaction

experienced

by

the

plaintiff.

See,

e.g.,

Tongate, 580 N.E.2d at 1225.
B.

Adequacy of Warning Label

Under Illinois law, the question of whether a physician was
sufficiently apprised of the harmful effects of a drug is a
critical one.

“Doctors who have not been sufficiently warned of

the harmful effects of a drug cannot be considered ‘learned
intermediaries’ ....”

Proctor, 682 N.E.2d at 1215.

“[T]he adequacy of warnings is a question of fact, not law,
for the jury to determine ....”
1220);
(Ill.

Batteast
1990)).

v.

Wyeth

See

also

Id. (citing Tongate, 580 N.E.2d

Laboratories,
Erickson,

151

Inc.,

560

F.Supp.2d

N.E.2d
at

315

962-63.

However, “[t]he sufficiency of the warning can become a question
of law where the warning is clear, accurate and unambiguous.”
Hernandez, 958 N.E.2d at 455 (citing Upjohn Co. v. MacMurdo, 562
So.2d 680 (Fla. 1990); Kelso v. Bayer Corp., 398 F.3d 640 (7th
Cir. 2005) (applying Illinois law)).
Here, Plaintiff argues that the Plavix label in effect at
the time of her injury was inadequate in several ways.
acknowledging

that

the

label

discloses

that

Plavix

While
causes

bleeding, she argues that the label did not fully reflect “the
risks and benefits (or lack thereof) of Plavix ....”
14

Pl. Opp.

at 23.

Specifically, she argues that the label should have

reflected:

(1)

that

dual

Plavix/aspirin

therapy

causes

a

substantial risk of serious bleeding, (2) that genetic testing
is required to determine a patient’s genetic response to Plavix,
(3) that continued use of Plavix beyond one year after a stent
is implanted is ineffective, and (4) that dual therapy is no
more effective than aspirin alone in preventing clotting.

In

support of her contentions, she relies on the expert testimony
of Dr. Lemuel A. Moye.
As

is

apparent

from

this

restatement

of

Plaintiff’s

arguments, she focuses heavily on the effectiveness of Plavix.
However, as I explained in more detail in my recent decision in
Solomon,

supra,

regarding

the

Slip

Op.

at

effectiveness

16-17,

of

Plaintiff’s

Plavix

are

arguments

misguided.

Her

failure-to-warn claim is premised on the fact that she suffered
substantial

bleeding

as

a

result

of

taking

both

Plavix

and

aspirin at the same time - not that Plavix was ineffective in
preventing her blood from clotting.
under

Illinois

adequately

law

warned

involves

A failure-to-warn claim

whether

prescribing

a

physicians

drug
of

manufacturer
the

potential

adverse reactions that could be caused by ingesting a drug;
manufacturers

of

prescription

drugs
15

must

“warn

prescribing

physicians . . . of the product's known dangerous propensities.”
Hansen, 764 N.E.2d at 42 (emphasis added).

Hence, although the

efficacy of a drug may play a role in a physician’s decision to
prescribe,
concerned
applying

the
with
the

failure-to-warn
a

drug’s

learned

doctrine

efficacy.

In

intermediary

is

not

this

doctrine

primarily

regard,
have

courts

held

that

permitting a plaintiff to pursue a claim for the “failure to
warn” of the efficacy of a drug would constitute an unwarranted
expansion of liability.

See In re Fosomax Prods. Liab. Litig.,

No. 06-1789, 2010 U.S. Dist. LEXIS 33260, at * 14-15 (S.D.N.Y.
Mar. 26, 2010) (applying Florida law).

See Needham v. White

Laboratories, Inc., 639 F.2d 394, 402 (7th Cir. 1981) (applying
Illinois

law

relevant

to

in

concluding

failure-to-warn

that

effectiveness

claim).

So

too,

of

drug

here,

I

not
find

Plaintiff's efficacy arguments unavailing.
Putting aside Plaintiff’s efficacy arguments, her failureto-warn claim boils down to her bare contentions that the Plavix
warning label should have better reflected that dual therapy
causes a substantial risk of serious bleeding and that genetic
testing is required.
Plaintif

fails

to

As will be explained in more detail below,
present

expert

testimony

to

support

these

contentions, thus, her failure-to-warn claim necessarily fails.
16

Courts in Illinois, unlike the courts of other states that
have been addressed in my recent learned intermediary decisions,
repeatedly

emphasize

the

importance

of

failure-to-warn prescription drug cases.
Trust

Co.,

572

N.E.2d

1030,

the

expert

testimony

in

In 1991, in Northern

Illinois

Appellate

first addressed the issue of expert testimony.

Division

Noting that the

Illinois Supreme Court had yet to rule on the issue8, the court
looked to the law of other states for guidance.
distilled

from

requirement

that

“is

case

law

the

logical

that

an

expert

extension

of

the

The court
testimony

fact

that

a

prescription drug manufacturer’s duty to warn is directed to the
prescribing physician.
someone

with

For that reason, only a physician or

specialized

knowledge

would

be

determine whether the warning was inadequate.”
Further,
testimony

the

court

requirement

noted,
for

those
failure

states
to

qualified

Id. at 1035-36.

found

warn

to

the

cases

expert

involving

prescription drugs analogous to the expert testimony requirement

8

The Illinois Supreme Court has yet to explicitly rule
upon whether expert testimony is required in drug manufacturer
failure-to-warn cases hence I look to the Illinois Appellate
Court for guidance on how the Illinois Supreme Court would rule.
See Spence v. ESAB Group, Inc., 623 F.3d 212, 216–217 (3d Cir.
2010). As illustrated below, courts applying Illinois law
continue to follow the reasoning of Northern Trust Co. over
twenty years after it was issued.
17

in medical malpractice actions.

Id. at 1036. Because Illinois

required expert testimony in medical malpractice actions, the
Northern Trust Co. court determined that the Illinois Supreme
Court would likewise require expert testimony in failure to warn
claims

against

drug

manufacturers.

It

then

pronounced

that

"expert testimony shall be necessary and proper . . . where a
drug manufacturer's liability for a prescription drug is based
upon its failure to provide adequate warnings.”

Id.9

In terms of the nature of the expert testimony, Northern
Trust

Co.

held

that

the

testimony

must

establish

that

the

manufacturer breached its duty to warn by failing to include the
warnings the plaintiff claims were omitted.

Id. at 1038.

This

is not a simple matter of “whether the [adverse reaction] was
listed among the side effects ....”

Id.

Rather, the question

the expert must answer is

9

The court noted one exception: In its view, the only
instance in which expert testimony is not required is where the
adequacy of the warning is “so obvious that a lay person could .
. . readily understand the insufficiency of the warning.”
Id.
The court held that this exception did not apply to the facts of
that case where the “meaning and medical implications of several
of the listed adverse reactions [found in the package insert
was] outside the knowledge of the ordinary lay person.” Id. at
1039.
Plaintiff here has not argued that a lay person could
understand the similarly complex implications of the bleeding
risk-related language at issue in this case.
Hence I do not
address whether the exception could have applied here, although
I would likely conclude that the exception does not apply.
18

whether
the
package
insert
and
other
materials designed to warn physicians of the
possible risks associated with the drug,
were adequate to advise a physician of the
potential dangers that were inherent in the
use of the product, despite the fact that
[the
adverse
reaction]
was
not
listed
specifically as a possible side effect of
the drug.
Id.

Because the expert testimony presented in Northern Trust

Co. did not address this more nuanced question, the Appellate
Court held that the plaintiff’s claim could not succeed as a
matter of law.
Since Northern Trust Co., both state and federal courts in
Illinois

continue

testimony standard.

to

hold

plaintiffs

to

an

exacting

expert

See, e.g., Hernandez, 958 N.E.2d at 454-55;

Sosnowski, 2012 WL 1030485 at *7; Erickson, 151 F.Supp.2d at
962-63.

See also 30A Ill. Law and Prac. Prod. Liab. § 17.

Recently,

in

Hernandez,

the

Appellate

claim

on

a

rejected

lack

of

a

plaintiff’s

failure-to-warn

testimony.

In that case, the plaintiff’s expert opined that the

package insert was inadequate.

based

Court

expert

However, he did not address if

“a practicing physician . . . would consider [the insert to be]
an adequate warning when determining whether to prescribe [the]
medication for a patient.”

958 N.E.2d at 456 (emphasis added).

19

Absent this specific testimony, the court concluded that the
plaintiff could not prevail.
recent

federal

Sosnowski

court

decision,

Id. at 457.10

decision

summary

applying

judgment

was

Similarly, in a

Illinois

law,

the

granted

where

the

“plaintiff offer[ed] no expert evidence that defendant's warning
failed

to

sufficiently

apprise

physicians

associated with the use of the [drug].”11

of

the

risks

2012 WL 1030485 at *8.

Consistent with this approach, an Illinois court denied summary
judgment where the expert testified that the adverse reaction at
issue in that case was acknowledged in the medical literature
and “should, in fact, be listed as a potential complication.”
Tongate, 580 N.E.2d at 957.
Because

Northern

Trust

Co.

continues

to

be

followed

by

courts in Illinois, and it has not been undermined by subsequent
Illinois Supreme Court law, I treat it as a strong indicator of

10

To be clear, the expert in that case was not qualified
to testify as to how a physician would interpret the package
insert because he was not an expert in pharmacology and had no
experience as practicing physician who prescribed medicine. Id.
at 713. Here, while the competency of Plaintiff’s expert is not
in question, I nonetheless find Hernandez instructive in
defining the nature of the expert testimony required in failure
to warn cases.
11

While this case involved a medical device rather than
a pharmaceutical drug, Illinois’ learned intermediary doctrine
law applies with equal force in medical device failure-to-warn
cases. See Hanson, 764 N.E.2d at 42.
20

how

the

Illinois

Supreme

Court

would

rule

on

the

expert

testimony requirement and, therefore, follow it here.

Accord

Independent Trust Corp. v. Stewart Information Services Corp.,
665 F.3d 930, 936 (7th Cir. 2012) (affirming district court's
treatment

of

Illinois

appellate

court

decision

as

persuasive

authority where Illinois Supreme Court had not yet passed on the
issue and the appellate court "was the first. . . only Illinois
appellate court to discuss the [ ] doctrine . . ., and its
holding

ha[d]

not

been

undermined

by

intervening

Illinois

precedent.")
As

in

Plaintiff

Northern
here

Co.

and

failed

has

Trust

Hernandez,

to

present

expert

and

Sosnowski,

testimony

that

addresses the key questions of how an Illinois physician would
have

interpreted

that

label

either

dual

therapy-induced bleeding or a need for genetic testing.

Dr.

adequately

warned

the

Plavix

physicians

label
of

and

the

whether

risks

of

Moye’s expert report renders no conclusions on these issues.
Indeed,

although

his

report

addresses

the

long-term

use

of

Plavix in post-stent patients, his comments consist merely of
recounting the results of the PRODIGY study.
study

as

suggesting

that

dual

21

therapy

He describes the

beyond

six

months

following the implant of stents creates an increased risk of
bleeding.12

However,

as

I

noted

in

Solomon,

supra

at

21,

"lacking in Dr. Moye’s report is any conclusion as to how . . .
Plavix’s warning label should have reflected the duration of
[the dual] therapy …."13
In short, notably absent from Dr. Moye's report is any
language addressing how a prescribing physician at the time of
Plaintiff’s injury would have interpreted the warning label or
any other medical information available at that time.

Nor does

he opine on what additional warning language – in addition to
the

already-included

bleeding

language

included in the package insert.

-

should

have

been

Even assuming that Dr. Moye's

conclusions with respect to the PRODIGY study are founded, Dr.

12

Moreover, the Court notes that it is giving Plaintiff
the benefit of the doubt in gleaning this excerpt from Dr.
Moye's expert report and reading his post-stent conclusions as
addressing increased bleeding. In her brief, Plaintiff presents
her post-stent, long-term use argument in connection with the
efficacy of Plavix, rather than with the incidence of increased
bleeding. For the reasons explained above, Plaintiff's efficacy
argument cannot and does not carry the day.
13

The other studies discussed by Dr. Moye do not relate
to Plaintiff’s medical history in this case, e.g., Plavix
studies dealing with stroke survivors, id. at ¶ 132, and are
therefore not pertinent to my analysis.
In addition, Dr. Moye
stresses the inefficacy of Plavix for those patients who have
suffered heart attacks or vascular disease.
Id. at ¶ 143-44.
As noted, Plaintiff’s efficacy arguments are unavailing.
22

Moye

renders

reflected

in

no

opinion

the

on

warning

how

that

label.

study

should

Accordingly,

have

been

Plaintiff

has

failed to present the type of expert testimony required by the
Illinois cases discussed above, and her claim necessarily fails.
Because her claim fails on adequacy grounds, I do not reach
proximate causation.

Accord Hernandez, supra at 48.

For this

reason, I also do not address the parties' arguments regarding
whether Illinois recognizes a heeding presumption, and whether
that presumption could be rebutted with testimony by Plaintiff's
physicians that they would have prescribed Plavix even with the
benefit of the sort of increased bleeding warning for which
Plaintiff advocates.
of

Illinois

noted

In a 2007 decision, the Southern District
that

the

Illinois

spoken on this issue clearly."

Supreme

Court

"has

not

Giles, 500 F.Supp.2d at 1066.

However, the district court suggested that the Illinois Supreme
Court would likely adopt the presumption, which could have the
effect of "reliev[ing] a plaintiff of her burden of proving an
important

facet

of

causation

whenever

a

manufacturer

Id. at

prescription drugs fails to warn doctors adequately."
1069.

of

In addition, while another district court held that the

presumption

applies

in

Illinois,

it

relied

upon

an

older

Illinois Appellate Division case that applied now-outdated Texas
23

law.

See Erickson, 151 F.Supp.2d at 970.

that

any

heeding

presumption

would

Moreover, in arguing
be

rebutted

by

the

physicians' testimony here, Defendant relies solely on out-ofstate law to support its contention.

See Def. Reply at 2-3, 2

n.3 (citing Oklahoma and Kansas law on rebuttability).
ruling

on

the

Plaintiff's

inadequacy

failure

jurisprudential

to

of

the

warning

warn

claim,

I

and

express

my

thicket

alone

decline
opinion

to
on

Since my
forecloses

enter

this

Illinois'

adoption of a heeding presumption.
III. Illinois Defective Design Claim
Plaintiff’s design defect claim is premised on Defendants’
alleged failure to warn.

See Opp. Br. at 37 (“Because there

were not proper instructions on the Plavix label, because the
label was not properly prepared, and because the benefits of
Plavix do not outweigh the risks, the Plaintiff can proceed on a
defective

design

claim.”)

Under

Illinois

law,

"[a]

product

bearing an adequate warning is not in [a] defective condition,
nor

is

it

unreasonably

dangerous."

Salerno

v.

Innovative

Surveillance Technology, Inc., 932 N.E.2d 101, 108 (Ill. App.
Ct. 2010) (discussing Restatement (Second) of Torts § 402 A
(1965)).

Moreover,

prescription

drugs

are

entitled

to

the

protection of Restatement (Second) of Torts § 402A, Comment k,
24

at 353 (1965), which "offers an exception to the general rule
making

a

seller

strictly

liable

even

when

the

product

was

properly prepared." De Bouse v. Bayer, 922 N.E.2d 309, 317 (Ill.
2009)

(discussing

drugs

in

the

comment

context

of

K's
an

applicability

Illinois

to

consumer

prescription
fraud

claim).

Hence, Plaintiff's defective design claim fails because she has
not demonstrated that the Plavix warning was inadequate.
IV.

Illinois Manufacturing Defect Claim
Just

as

with

Plaintiff's

design

defect

claim,

her

manufacturing defect claim is premised on a failure to warn
theory.

As Illinois law provides that products bearing adequate

warnings are not defective, Salerno, 932 N.E.2d at 108, and she
has not demonstrated that the Plavix warning was inadequate, her
manufacturing defect claim also fails.
V.

Negligence Claim
Plaintiff’s

negligence

claim

is

nothing

more

than

a

restatement of her defective design, defective manufacturing,
and

failure-to-warn

negligently
inspected,

claims.

designed,
packaged,

and/or sold Plavix.

Plaintiff

developed,

promoted,

avers

Defendants

manufactured,

marketed,

distributed,

See Am. Comp., ¶¶ 65-69.

25

that

tested,
labeled

Because the Court

has

found

that

none

of

her

claims

have

merit,

this

claim

necessarily fails.
VI.

Discovery Request Pursuant to Rule 56(d)
As

a

final

note,

Plaintiff

pursuant to Fed. R. Civ. P. 56(d).
herein,

there

opportunities
Plaintiff

is
to

basis

to

is

provide

Plaintiff

discovery

additional

Moreover,

much

relates

to

discover
neither

additional

Based on the Court’s ruling

discovery.
to

which,

Plaintiff’s claims.
the

seek

proposes

effectiveness,

take

no

seeks

relevant

nor

of

what

Plavix’s

probative

of

Also, Plaintiff has had the opportunity to

depositions

of

Plaintiff’s

treating

physicians.

Accordingly, Plaintiff’s position that the motion is premature
and further discovery should be taken is rejected.
CONCLUSION
For the foregoing reasons, Defendants’ motion for summary
judgment is granted in its entirety.

As a result, Plaintiff’s

Amended Complaint is dismissed.
An appropriate Order shall issue.

Dated: January 11, 2013

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

26