MATTSON v. BRISTOL-MYERS SQUIBB COMPANY et al

Filing 97

OPINION filed. Signed by Judge Freda L. Wolfson on 4/22/2013. (eaj)

*NOT FOR PUBLICATION*
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
______________________________
SHARON MATTSON,

:
Civil Action No. 07-908 (FLW)
Plaintiff,

:

v.
OPINION

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

:

Defendants.
:
______________________________
WOLFSON, District Judge:
Pro

se

Plaintiff

Sharon

Mattson1

(“Plaintiff”

or

“Ms.

Mattson”) brings the instant suit against Defendants, Bristol
Myers-Squibb Company (“BMS”), Sanofi-Aventis U.S., L.L.C., SanofiAventis U.S., Inc., and Sanofi-Synthelabo, Inc. (collectively,
“Defendants”),

alleging that she suffered injuries as a result of

Defendants’ 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 California
state and common law claims against Defendants, including Failureto-Warn, Manufacturing Defect and Negligence.2 Before the Court is
1

Ms. Mattson was initially represented by counsel;
however, her attorney withdrew from representation on October 7,
2011. After unsuccessfully attempting to retain new counsel,
Plaintiff has been proceeding pro se since that time.
2

In her Original Complaint, Plaintiff asserted New
Jersey state and common law claims against Defendants. Following

Defendants’ motion for summary judgment based upon a number of
theories,

including

California law.

the

learned

intermediary

doctrine

under

In response, Plaintiff submitted four handwritten

letters, without any exhibits, declarations or affidavits. For the
reasons that follow, Defendants’ motion for summary judgment is
GRANTED and all counts in the Amended Complaint are dismissed.3
BACKGROUND4
A.

Plavix
Plavix is a drug that inhibits blood platelets from forming

clots.

The drug was initially approved by the United States Food

and Drug Administration (“FDA”) for use as monotherapy, i.e., taken

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 California state law. See Opinion dated December 30, 2009,
pp. 2-3. Therefore, California law controls on this motion.
3

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.
Mattson in this case. Moreover, I have been designated to handle
the Plavix Multidistrict Litigation, and I am 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., California, 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 preliminarily filed opinion in Solomon v. BMS, Civil
Action No. 07-1102 (FLW), where appropriate.
4

The following facts are undisputed unless otherwise

noted.
2

without another drug, in patients with recent heart attack, stroke,
or diagnosed peripheral vascular disease (“PVD”).
Statement, ¶ 2.

See Defs.

Thereafter, the FDA approved Plavix for dual

therapy with aspirin, which also contains antiplatelet effects, in
the treatment of patients with particular types of acute coronary
syndrome (“ACS”).5

Id. at ¶ 4.

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 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.
CAPRIE6, PLAVIX was associated with a rate

In
of

5

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).
6

According to BMS, the clinical evidence for the risks
of PLAVIX is derived from two double-blind trials: (i) the CAPRIE
3

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.
In CURE, PLAVIX use with aspirin was associated with an
increase in bleeding compared to placebo with aspirin
(see Table 3)7. 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.

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. Plaintiff contests the
accuracy of these clinical trials; those arguments will be
further discussed in this Opinion.
7

Table 3 of the labeling includes certain “incidence of

bleeding.”
4

See, generally, February 2002 Plavix Labeling.
B.

Plaintiff’s Medical History
According to her medical record, Plaintiff has a long history

of heart disease and related issues.8

In January 2005, Plaintiff

went to her primary doctor, Maria T. Banico, MD, for complaints of
worsening heart palpitations and accompanying chest pain.
Banico’s Notes dated January 3, 2005.

See Dr.

During this time, while

Plaintiff was taking aspirin, her chest pain persisted.

See Dr.

Banico’s Notes dated January 10, 2005 and February 28, 2005.
Plaintiff was advised to see a cardiologist.
In

early

March

2005,

Plaintiff’s

cardiologist

diagnosed

Plaintiff with unstable angina and recommended that she proceed
with a coronary angiogram and stent placement. See Dr. Oh’s Report
dated March 7, 2005.
performed

a

heart

On March 30, 2005, Dr. Gregg Hopkins

catheterization

and

coronary

angiolasty

to

resolve a severe blockage in one of Plaintiff’s coronary arteries.
See Dr. Hopkins’ Report dated April 2, 2005.
placed in Plaintiff’s artery.

A stent was also

After the surgery, Dr. Hopkins

instructed Plaintiff to take aspirin as well as Plavix. Id., p. 2.

8

The Court notes that in response to Defendants’ motion
for summary judgment, Plaintiff did not submit any evidence
regarding her medical history. Rather, Plaintiff, in her
handwritten letters, explains her condition as a result of taking
Plavix, and in a general fashion, Plaintiff complains about the
use of Plavix, as well as Defendants’ conduct. As such, the
Court relies on Defendants’ submissions of Plaintiff’s medical
records from her treating physician and cardiologists to piece
together her medical history.
5

Plaintiff continued on dual therapy until December 29, 2005,
when she went to the emergency room with rectal bleeding.
Discharge Summary dated January 3, 2006.

See

While Plaintiff was

admitted and closely monitored, a colonoscopy on January 3, 2006,
revealed no signs of bleeding.

Plaintiff was discharged on that

day, and instructed to stop taking Plavix.

See Id., p. 2.

According to the record, Plaintiff has not taken Plavix since that
time, and no additional incidences of rectal bleeding are noted.
C.

Plaintiff’s Amended Complaint
Due to the rectal bleeding allegedly resulting from taking

Plavix,

Plaintiff

asserting

product

brings

the

liability

instant
related

suit
causes

against
of

Defendants

action,

under

California state law for failure to warn, manufacturing defect and
negligence.

See Am. Compl., Count I - Count III.

Although these

claims are characterized differently, they essentially turn on
whether Defendants adequately warned that Plavix carries a risk of
bleeding complications.

In that regard, Defendants argue that the

learned intermediary doctrine precludes Plaintiff from suing them
because

the

doctrine

excuses

drug

manufacturers

from

warning

Plaintiff, individually, when these manufacturers have properly and
adequately warned the prescribing physicians regarding Plavix’s
risks.

It is this issue upon which the Court will focus.

6

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. 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."
423.

Kaucher, 455 F.3d at

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.
477 U.S. at 323.

Celotex Corp.,

Once the moving party has met this burden, the

7

nonmoving party must 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 (3d Cir. 1991)).
Moreover, the 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.

8

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.

California Failure-to-Warn Claim
Because Plaintiff does not make any legal arguments or present

any

relevant

responses

to

Defendants’

invocation

of

the

intermediary doctrine, the Court will undertake its own independent
analysis of the law.
It is well-settled that, in California, a manufacturer of
prescription drugs owes to the medical professional the duty of
providing adequate warnings if it knows, or has reason to know, of
any dangerous side effects of its drugs. Carlin v. The Superior
Court,

13

Cal.

4th

1104,

1112-13

(1996).

Under

the

learned

intermediary doctrine, a manufacturer of a prescription drug is
obliged to warn doctors – not patients – of potential side-effects
associated with its pharmaceutical products. Id. at 1116; Brown v.
Superior Court, 44 Cal. 3d 1049, 1061-1062 (1988); Stevens v.
Parke, Davis & Co., 9 Cal. 3d 51, 65 (1973)("In the case of medical
prescriptions, if adequate warning of potential dangers of a drug
has

been

given

to

doctors,

there

is

no

duty

by

the

drug

manufacturer to insure that the warning reaches the doctor's
patient for whom the drug is prescribed (internal quotations
omitted)).

9

Accordingly, “a manufacturer of prescription drugs discharges
its duty to warn if it provides an adequate warning to the
physician about any known or reasonably knowable dangerous side
effects of a medicine, regardless of whether the warning reaches
the patient.” Carlin, 13 Cal. 4th at 1116-17. A plaintiff asserting
causes of action for failure to warn must prove not only that no
warning was provided or that the warning was inadequate, but also
that the inadequacy or absence of a warning caused the plaintiff's
injury. Wendell v. Johnson & Johnson, No. 09-4124, 2012 U.S. Dist.
LEXIS 103986, at *23 (N.D. Cal. 2012); see Plummer v. Lederle
Laboratories, 819 F.2d 349, 358 (2d Cir. 1987) (applying California
law). "[A] product defect claim based on insufficient warnings
cannot survive summary judgment if stronger warnings would not have
altered the conduct of the prescribing physician."

Motus v.

Pfizer, Inc., 358 F.3d 659, 661 (9th Cir. 2004).9
Here, Plaintiff’s failure-to-warn claim fails because the
learned intermediary doctrine excuses Defendants from liability in
this case.

First and foremost, Plavix’s warning label clearly

cautions physicians and others that “PLAVIX use with aspirin was
associated with an increase in bleeding compared to placebo with

9

Although several states have adopted a heeding
presumption in a failure-to-warn context, to be clear, California
has not adopted such a presumption. Motus v. Pfizer, Inc., 196
F. Supp. 2d 984, 995-95 (C.D. Cal. 2001); Dimond v. Caterpillar
Tractor Co. 65 Cal. App.3d 173, 185, n. 8 (1976); Johnson v.
Johnson & Johnson, No. B211123, 2010 Cal. App. Unpub. LEXIS 8274,
at *37 (2nd App. Dist. Oct. 20, 2010).
10

aspirin.

There was an excess in major bleeding in patients

receiving PLAVIX plus aspirin compared with placebo plus aspirin,
primarily gastrointestinal . . . sites.”
Labeling.

See February 2002 Plavix

In addition, the label references a table, taken from

the CURE study, which publishes statistics regarding incidence of
bleeding when taking Plavix and aspirin together compared to taking
aspirin with a placebo (e.g., Major bleeding: 3.7% v. 2.7%).
Id., Table 3.

See

It is, then, Plaintiff’s burden to demonstrate that

the treating physician would not have used or prescribed the
product

but

for

the

inadequate

warning.

Having

reviewed

Plaintiff’s cardiologist’s testimony, the Court finds a stronger
warning would have not have changed the physician’s decision to
prescribe Plavix to Plaintiff.
As the interventionalist, Dr. Hopkins testified that Plaintiff
was placed on Plavix and aspirin because her medical condition was
serious after her surgery, and that the likelihood of Plaintiff
having heart-related complications was high.
Dep., T57:13-59:6.

See Dr. Hopkins’

In that respect, Dr. Hopkins explained that

based upon Plaintiff’s medical situation, there was a strong
likelihood of blood clotting with the placement of stents in
Plaintiff’s arteries.

Id., T64:19-65:4.

The doctor determined

that placing Plaintiff on dual therapy with Plavix and aspirin was
not only the standard of care at the time, but it was in her best
interest.

Id., T65:5-14.

11

Indeed, Dr. Hopkins was aware that there were risks associated
with this type of treatment. Importantly, Dr. Hopkins acknowledged
that dual therapy could cause serious risk of bleeding in patients.
He explained:

“The biggest risk is bleeding . . . . [I]t can cause

bleeding from any location, typically patients who are taking
aspirin and Plavix will have increased bruising, or they’ll bruise
easily.

It takes longer for a cut or a scratch to stop oozing.

They can also develop nosebleeds.

They can have gastrointestinal

bleeding . . . It can also be lower gastrointestinal bleeding.”10
Id., T63:1-10. However, the cardiologist insisted that despite the
risks, it

was

important

that

these

drugs

were

prescribed to

Plaintiff to prevent further complications. Id., T65:1-4. In fact,
Dr. Hopkins explained that the standard of medical practice today,
let alone in 2005, is to provide the combination of Plavix and
aspirin for patients like Plaintiff, and that he would continue to
prescribe Plavix to patients like Plaintiff.

Id., T66:3-67:18.

Furthermore, Dr. Hopkins testified that he did not solely rely on
Plavix’s warning

labels

to

apprise

himself

benefits of the drug.

Id. T34:15-35:21.

decision,

also

Continuing

Dr.

Hopkins

Medical

Education

relied

on

Symposia,

10

of

the

risks

To make an informed
medical
and

journals,

specific

the

studies

As it is understood by the medical community, lower
gastrointestinal bleeding includes symptoms such as rectal
bleeding, which was experienced by Plaintiff. See Discharge
Summary dated January 3, 2006.
12

and

regarding Plavix.

Id.

Ultimately, the doctor reiterated that he

would not have prescribed anything different to Plaintiff knowing
what he knows about Plavix today.

Id., T67:1-18.

It is clear from the above-testimony of Dr. Hopkins that he
was aware of the serious risks of bleeding when placing Plaintiff
on dual therapy with Plavix and aspirin.
opinions

were

Plaintiff’s

unequivocal:

condition

because

outweighed

the

the

Indeed, Dr. Hopkins’
medical

risks,

the

benefits

for

doctor

was

confident that the treatment he had provided for Plaintiff was
medically necessary and appropriate.

There is no evidence in this

case – testimonial or otherwise – to support a conclusion that a
different warning would have led Plaintiff’s cardiologist to alter
Plaintiff’s treatment.

Nor is there any objective evidence in the

record that would suggest that a different warning would have
affected the decision of a reasonable doctor to prescribe Plavix
and aspirin for Plaintiff’s condition. Even more importantly, Dr.
Hopkins represented that he would not have changed the prescription
for Plaintiff even understanding the additional risks that have
been raised by Plaintiff’s allegations in this litigation.
Accordingly, because there is no causation evidence to support
Plaintiff’s failure-to-warn claim, it is summarily dismissed.
III. California Manufacturing Defect Claim
To prove a negligent manufacturing claim under California law,
“a plaintiff must first show that the product as delivered departed

13

from the governing specifications.”

Carson v. Depuy Spine, Inc.,

365 Fed. Appx. 812, 814 (9th Cir. 2010).

A manufacturing defect

occurs when the product "differs from the manufacturer's intended
result or from other ostensibly identical units from the same
product line." Barker v. Lull Engineering Co., 20 Cal. 3d 413, 429
(1978). It logically follows that if a product meets the design
specifications applicable at the time of manufacture, there is no
manufacturing defect. In re Coordinated Latex Glove Litigation, 99
Cal. App. 4th 594, 612-13 (2002).
adduced

by

Plaintiff.

Here, no such evidence has been

Indeed,

the

genesis

of

Plaintiff’s

complaints about Plavix is the drug’s anti-platelet properties,
which allegedly caused her to suffer injuries related to massive
bleeding.

Those anti-clotting properties are the intended effects

of Plavix, and therefore, by Plaintiff’s own allegations, the
nature of her claim is not premised on whether the drug deviated
from the construction or specifications of Plavix.

Without any

evidence showing that Plavix was defectively manufactured, this
claim is dismissed.
IV.

Negligence Claim
Plaintiff’s

negligence

claim

is

nothing

more

than

a

restatement of her defective manufacturing and failure-to-warn
claims.

Because the Court has found that none of her claims have

merit, this claim necessarily fails.

14

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: April 22, 2013

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

15