LABARRE v. BRISTOL-MYERS SQUIBB COMPANY et al
Filing
114
OPINION filed. Signed by Judge Freda L. Wolfson on 1/11/2012. (mmh)
*NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
______________________________
ELOISE LABARRE, as surviving
Spouse and Administratrix of
the Estate of Edward Clyde
LaBarre, Sr., Deceased,
:
Civil Action No. 06-6050(FLW)
:
:
OPINION
Plaintiff,
v.
:
BRISTOL-MYERS SQUIBB CO.,
et al.,
:
:
Defendants.
______________________________:
WOLFSON, District Judge:
Plaintiff Eloise LaBarre (“Plaintiff”), as surviving spouse
and administratrix of the Estate of Edward Clyde LaBarre, Sr. (“Mr.
LaBarre”), 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 her late husband, Mr. LaBarre,
suffered
injuries
fatal
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 Florida state and common law
claims against Defendants, including Failure-to-Warn, Defective
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 Florida
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
clots.
The drug was initially approved by the United States Food
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 Florida state law. See Opinion dated
December 30, 2009, pp. 2-3. Therefore, Florida 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 Mr.
Mr. LaBarre 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., Florida, 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 primary filed opinion in Solomon v. BMS, Civil
Action No. 07-1102 (FLW), where appropriate.
3
The following facts are undisputed unless otherwise
noted.
2
and Drug Administration (“FDA”) for use as monotherapy, i.e., taken
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”).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 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.
4
In
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
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.
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
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. Plaintiff contests the
accuracy of these clinical trials; those arguments will be
further discussed in this Opinion.
6
Table 3 of the labeling includes certain “incidence of
bleeding.”
4
(0.1%), and fatal bleeding (0.2%), was the same in both
groups.
See, generally, February 2002 Plavix Labeling.
B.
Plaintiff Medical History
Mr. LaBarre had a history of coronary artery related health
issues.
Based on the record, Mr. LaBarre’s first myocardial
infarction, or heart attack, occurred in June 1990.
Report dated July 6, 1990, p. 1.
See PTCA
Subsequently, an angioplasty was
performed to clear his blocked coronary arteries. Id. at pp. 3-4.
The next incident related to Mr. LaBarre’s ACS occurred in October
2002.
At that time, Mr. LaBarre presented to the emergency room
with “an episode of midsternal chest pain which radiated down the
right arm and shoulder.”
2002.
See Discharge Summary Dated November 14,
Dr. Leisa Bailey, Mr. LaBarre’s primary physician, in
consultation
with
Mr.
LaBarre’s then-cardiologist,
Dr.
Leland
Eaton, prescribed Plavix and nitroglycerin. See Id. Shortly after,
in November 2002, Dr. Eaton performed a coronary artery bypass
grafting, or a double bypass operation, on Mr. LaBarre.
Discharge Summary dated July 3, 2003, p. 2.
See
Because of the
operation, Mr. LaBarre was instructed to stop taking Plavix and
even after the bypass surgery, Mr. LaBarre did not resume taking
Plavix; rather, he was instructed to take aspirin alone.
See Dr.
Bailey Dep., T110:14-111:12.
In June 2003, Mr. LaBarre again went to the emergency room
with a heart attack.
See Discharge Summary dated July 3, 2003, p.
5
2.
This time – more than seven months after his operation – Mr.
LaBarre was put on Plavix and aspirin before being discharged from
the hospital.
Id., p. 2. Thereafter, Dr. Benjamin Craven became
Mr. LaBarre’s cardiologist, and between the period of July 2003 and
July 2004, Dr. Craven continued to prescribe Plavix and aspirin for
Mr. LaBarre .
Dr. Baily kept Mr. LaBarre on dual therapy until
December 2004.
In early December 2004, Mr. LaBarre bumped his head while
working in his barn.
See LaBarre Dep., T252:14-20.
Approximately
two weeks later, Mr. LaBarre suffered a severe headache and became
unconscious.
See Southeast Alabama Medical Center History and
Physical, pp. 1-2.
Mr. LaBarre was diagnosed with a “large acute
subdermal hematoma,” which caused brain stem damage.
on December 21, 2004.
Id.
He died
The cause of death on the Death Certificate
indicated that Mr. LaBarre’s Subdermal hematoma was a consequence
of the Plavix therapy.
C.
See Death Cert. dated January 27, 2005.
Plaintiff’s Amended Complaint
Because of the death of her husband, Plaintiff brings this
wrongful death and survival action against Defendants, asserting
product liability related causes of action, under Florida state
law, for defective design, manufacturing defect, failure to warn,
and negligence.7
See Am. Compl., Count I - Count IV.
7
Although
On December 30, 2009, this Court dismissed Plaintiff’s
claims for negligent misrepresentation (Count V) and for
violation of the Florida Unfair Deceptive Trade Practices Act
6
these claims are characterized differently, they essentially turn
on whether Defendants adequately warned that Plavix carried a risk
of bleeding complications.
this
motion
Plaintiff
that
from
the
In that regard, Defendants argue on
learned
suing
them
intermediary
because
the
doctrine
doctrine
precludes
excuses
drug
manufacturers from warning Mr. LaBarre, 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.
(Count VI).
See Order dated December 30, 2009.
7
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
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
8
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.
Florida Failure-to-Warn Claim
Plaintiff maintains that Defendants failed to adequately warn
Mr. LaBarre’s prescribing physicians of the potential for bleeding
complications from taking Plavix.
More specifically, Plaintiff
insists that Mr. LaBarre’s prescribing physicians were not warned
1) regarding the substantial risk of serious bleeding caused by
taking Plavix with aspirin; and 2) that Plavix does not provide any
benefit to patients who take Plavix in addition to aspirin longer
than a few months. In essence, Plaintiff claims that Defendants
failed to inform physicians of the true risk of bleeding and the
lack of efficacy of Plavix.
9
Generally, under Florida law, a manufacturer of a "dangerous
commodity," such as a prescription drug, has a duty to warn
consumers of the known risks of using its product.
Horrillo v.
Cook Inc., No. 10-1537, 2012 U.S. App. LEXIS 26317, at *6-7 (11th
Cir. Nov. 7, 2012) (citing Buckner v. Allergan Pharms., Inc., 400
So. 2d 820, 822 (Fla. 5th DCA 1981)). Failure to provide that
warning
may
resulting
render
harm.
Id.
the
manufacturer
at
*7.
strictly
However,
in
liable
the
for
context
any
of
prescription drugs, Florida law applies the learned intermediary
doctrine, whereby the duty to warn flows from the drug manufacturer
to the physician, and not the ultimate consumer. Bailey v. Janssen
Pharmaceutica, Inc., 288 Fed. Appx. 597, 608 (11th Cir. 2008); Felix
v. Hoffmann-LaRoche, Inc., 540 So. 2d 102, 104 (Fla. 1989) ("At the
outset, it is clear that the manufacturer's duty to warn of [the
drug's] dangerous side effects was directed to the physician rather
than the patient.");
E.R. Squibb & Sons v. Fames, 697 So. 2d 825,
827 (Fla. 1997).
Under this doctrine, “[s]o long as a drug's warning to the
prescribing physician is adequate, a manufacturer will not be
strictly liable for failure to warn when a doctor prescribes a
particular drug or fails to inform his patient of certain risks
10
associated with the medication.”8
Id. The underlying policy for
the learned intermediary doctrine is that,
prescription drugs are likely to be complex
medicines, esoteric in formula and varied in effect.
As a medical expert, the prescribing physician can
take into account the propensities of the drug, as
well as the susceptibilities of his patient. His is
the task of weighing the benefits of any medication
against its potential dangers. The choice he makes is
an informed one, an individualized medical judgment
bottomed on a knowledge of both patient and
palliative. Pharmaceutical companies then, who must
warn ultimate purchasers of dangers inherent in
patent drugs sold over the counter, in selling
prescription drugs are required to warn only the
prescribing physician, who acts as a "learned
intermediary" between manufacturer and consumer.
Buckner v. Allergan Pharms., 400 So. 2d 820, 822 (Fla. 5th DCA
1981).
Accordingly, based on the policy rationale, if an adequate
warning exists, the manufacturer of the drug would not be held
liable for failure to warn. See Felix, 540 So. 2d at 105.
8
Plaintiff implores this Court to reject the learned
intermediary doctrine when examining Florida product liability
laws. In so doing, Plaintiff relies on a decision rendered by
the West Virginia Supreme Court in State ex rel. Johnson &
Johnson Corp. v. Karl, 647 S.E. 2d 899 (W. Va. 2007), wherein the
Court eliminated the learned intermediary doctrine in that state.
As Plaintiff should be aware, because Florida law controls in
this case, this Court, sitting in diversity, is bound to follow
state law as announced by the highest court in Florida. See
Nuveen Mun. Trust v. Withumsmith Brown, P.C., 692 F.3d 283, 315
(3d Cir. 2012). And, the Florida Supreme Court has long
recognized the learned intermediary doctrine in the context of
prescription drugs. See Felix, 540 So. 2d at 104. Ever since
Felix, Florida courts have consistently applied the doctrine to
pharmaceutical liability cases. See Colville v. Pharmacia &
Upjohn Co. LLC, 565 F. Supp. 2d 1314, 1320 (N.D. Fla.
2008)(collecting cases). Accordingly, this Court has no basis to
depart from established Florida law.
11
In
order
to
prove
strict
liability
based
on
a
drug's
insufficient warning, the plaintiff must establish "(1) that the
warnings accompanying the [product] were inadequate; (2) that the
inadequacy of the warnings proximately caused Plaintiff's injury;
and (3) that Plaintiff in fact suffered an injury by using the
product."9
Dist.
LEXIS
Hosler v. Alcon Labs., Inc., NO. 16-60025, 2012 U.S.
145176,
at
*25
(S.D.
Fla.
Oct.
9,
2012)(citing
Colville, 565 F. Supp. 2d at 1320).
With respect to the first prong, the Florida Supreme Court has
instructed that the adequacy of the warning turns on whether the
"warnings were adequate to warn a physician of the possibility that
[the medicine] might be causing the condition experienced" by the
Plaintiff.”
Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683 (Fla.
1990). That determination must be made through the testimony of an
expert. Beale v. Biomet, Inc., 492 F. Supp. 2d 1360, 1365 (S.D.
Fla. 2007).
In that regard, courts in Florida have not hesitated
to dismiss cases on summary judgment when the plaintiff "failed to
present an expert witness in support of her claim of inadequate
warning." Paparo v. Ortho-McNeil Pharmaceutical, No. 05-81044, 2007
U.S. Dist. LEXIS 2356, at *4 (S.D. Fla. Jan. 10, 2007) (citing
Haggerty v. Upjohn Co., 950 F.Supp. 1160, 1168 (S.D. Fla. 1996);
MacMurdo, 562 So.2d at 683; and Felix, 540 So.2d at 104); see also
9
For the purposes of this motion, Defendants do not
dispute that Plaintiff is able to prove injury-in-fact.
12
Humphreys v. Gen. Motors Corp., 839 F. Supp. 822, 825 (N.D. Fla.
1993) (finding that the defendant is "permitted to rely upon the
complete
absence
of
proof
of
an
essential
element
of
[p]laintiff['s] case to support its motion for summary judgment").
Importantly, the Florida Supreme Court has advised that while in
many instances the adequacy of warnings concerning drugs is a
question of fact, this inquiry “can become a question of law where
the warning is accurate, clear, and unambiguous.”
Felix, 540 So.
2d at 105.
On the issue of causation, Florida law requires the plaintiff
to prove by a preponderance of the evidence, with "reasonable
medical probability," that the drug manufacturer’s alleged failure
to warn was the proximate cause of Plaintiff's injury. Christopher,
53 F.3d at 1191(citing Reaves v. Armstrong World Industries, Inc.,
569 So. 2d 1307, 1309 (Fla. Ct. App. 1990)). "In other words,
plaintiffs must show that is 'more likely than not' that the
defendant's act was a substantial factor in bringing about the
injury." Christopher v. Cutter Lab., 53 F.3d 1184, 1192 (11th Cir.
1995)(quoting Gooding v. University Hospital Building, Inc., 445
So. 2d 1015, 1018 (Fla. 1984)). "A mere possibility of such
causation is not enough; and when the matter remains one of pure
speculation or conjecture, or the probabilities are at best evenly
balanced, it becomes the duty of the court to direct a verdict for
the defendant." Reaves, 569 So. 2d at 1309.
13
To prove causation, the plaintiff must show that the “‘failure
of [a] manufacturer to provide the physician with an adequate
warning of the risks associated with a prescription product is not
the proximate cause of a patient's injury if the prescribing
physician had independent knowledge of the risk that the adequate
warning should have communicated.’” Beale, 492 F. Supp. 2d at 1365
(S.D. Fla. 2007)(quoting Christopher, 53 F.3d at 1192)(emphasis
added).
Thus, “the causal link between a patient's injury and the
alleged failure to warn is broken when the prescribing physician
had ‘substantially the same’ knowledge as an adequate warning from
the manufacturer should have communicated to him." Id.
Moreover,
Plaintiff must show that the physician would not have made the same
prescribing decision with a different warning. See Levin v. Wyeth,
Inc,. NO. 09-854, 2010 U.S. Dist. LEXIS 130855, at *11-12 (M.D.
Fla. Dec. 10, 2010); see also Hoffmann-LaRoche Inc. v. Mason, 27
So. 3d 75, 77 (Fla. 1st DCA 2009)(finding a lack of causation
because
“Appellee
presented
no
evidence
from
either
treating
physician that a differently worded warning would have resulted in
either physician not prescribing Accutane for his extreme acne.”).
A.
Accuracy of Plavix’s Warning Label
At the outset, the Court finds that, based on the record,
there is evidence to support the allegation that the cause of Mr.
LaBarre’s death could be attributed to his Plavix therapy.
e.g., Death Cert. dated January 27, 2005.
14
See,
However, the inquiry
here is not whether taking Plavix ultimately contributed to Mr.
LaBarre’s death, but rather, whether the learned intermediary
doctrine excuses Defendants from liability based upon the policy
rationale espoused by the Florida Supreme Court. Because the Court
answers in
the
affirmative,
Plaintiff’s
failure-to-warn
claim
fails.
For her failure-to-warn claim, Plaintiff essentially complains
that Defendants did not adequately warn about the substantial risk
of serious bleeding caused by taking Plavix with aspirin, and that
Plavix loses its efficacy for patients on dural therapy for more
than
a
few
months.
Indeed,
Plaintiff
dedicates
much
of
her
arguments to the effectiveness of Plavix.
As an initial matter, this Court finds that although Plaintiff
presents various studies and articles challenging the efficacy of
Plavix in certain types of patients, none of those studies are
relevant
to
Mr.
LaBarre’s
medical
situation.
For
example,
according to Plaintiff’s expert, Dr. Moye, the Defendant-sponsored
MATCH study in 2004 found that Plavix and aspirin was no better
than aspirin alone in treating patients with recurrent transient
ischemic stroke events.
In that regard, based on an article
published by the American Heart Journal, Plaintiff claims that more
than 40% of Plavix use was for conditions where there was no
evidence that Plavix had any effectiveness over aspirin or any
effectiveness at all.
See Pl.’s Ex. 16.
15
Plaintiff credits
Defendants’ aggressive marketing as the reason why physicians
continue
to
efficacy.
prescribe
Plavix
See Pl. Ex. 28.
in
the
absence
of
evidence
of
Notwithstanding this position, Mr.
LaBarre, however, did not suffer from transient ischemic stroke he was placed on dual therapy because of complications stemming
from ACS.
Thus, this study is irrelevant to Plaintiff’s claim.
In fact, the majority of the Plavix efficacy studies cited by
Plaintiff are unrelated to Mr. LaBarre’s personal circumstances.
In one example, Plaintiff cites certain studies to show that Plavix
is ineffective as post-operative treatment for coronary bypass. See
Pl. Ex. 20.
Mr. LaBarre was treated with Plavix in the summer of
2003 when he suffered a heart attack, not after his prior bypass
surgery in November 2002.
To the extent Plaintiff suggests that
these studies are relevant – despite the time gap – Plaintiff has
failed
to
link
circumstances.
the
studies’
conclusions
to
Mr.
LaBarre’s
Similarly, the studies upon which Plaintiff rely
regarding Plavix’s ineffectiveness for patients 75 years or older
has limited relevance since Mr. LaBarre was put on Plavix before he
was 75 years old.
Although Mr. LaBarre was 74 years old when he
died, Plaintiff does not offer any expert testimony as to how those
studies should have impacted Plavix’s warning label, insofar as it
relates to Mr. LaBarre, who was approaching 75 years of age.
This
is critical because as the Court has stressed previously, Plaintiff
must present the testimony of an expert in order to establish the
16
inadequacy of a particular warning label. Beale, 492 F. Supp. 2d at
1365.
Another glaring example is Plaintiff’s reliance on studies
that
have
found
that
Plavix,
when
taken
effective than taking aspirin by itself.
alone,
is
not
more
As is clear from the
record, however, Mr. LaBarre took Plavix in combination with
aspirin, and therefore, any evidence comparing the efficacy of
aspirin taken alone and Plavix taken alone has no bearing on
Plaintiff’s case. Overall, Plaintiff has failed to explain how any
of the studies regarding efficacy are relevant to the adequacy of
the warnings with respect to Plaintiff’s health condition, i.e.,
ACS. Thus, these studies fail to raise a genuine issue of material
fact on the question of whether Plavix’s warnings were adequate.
Moreover, it appears that Plaintiff’s efficacy arguments are
not relevant
in
the
context
of a
failure-to-warn
analysis.
Plaintiff’s claim is essentially premised on the fact that he
suffered substantial bleeding as a result of taking both Plavix and
aspirin at the same time - not that Plavix did not work.
As the
Court has previously noted, in Florida, a drug manufacturer is
required to provide an adequate warning of its product if it knows
of any potential harm that may result from the use of its product.
In
other
words,
a
proper
warning
should
adequately
alert
a
physician to any danger or harm that may result from ingesting the
drug.
See Pinchinat v. Graco Children’s Products, Inc., 390 F.
17
Supp. 2d 1141, 1146 (M.D. Fla. 2005)(citing Ferayorni v. Hyundai
Motor Co., 711 So. 2d 1167, 1772 (Fla. Ct. App. 1998)). Permitting
Plaintiff to pursue his failure-to-warn claim on an efficacy theory
would impermissibly expand liability under Florida law on the
adequacy of pharmaceutical warning labels.
See In re Fosamax
Prods. Liab. Litig., No. 06-1789, 2010 U.S. Dist. LEXIS 33260, at
* 14-15 (S.D.N.Y. Mar. 26, 2010)( “To allow Plaintiff to pursue a
claim for the ‘failure to warn’ of the efficacy of a drug would be
an expansion of liability under Florida law.”); see also Tobin v.
Astra Pharmaceutical Prods., Inc., 993 F.2d 528, 536 (6th Cir.
1993), abrogated on other grounds by J. McIntyre Machinery, Ltd. v.
Nicastro,
131
S.Ct.
2780
(2011)(finding
that
the
plaintiff’s
argument regarding the efficacy of the drug, ritodrine, should not
be made in the context of a failure-to-warn claim.); Neeham v.
White Labs., Inc., 639 F.2d 394, 402 (7th Cir. 1981).10
The remaining studies and expert opinions upon which Plaintiff
rely are simply not sufficient to show that the warnings regarding
the risks of bleeding in patients who suffer from ACS, were
inadequate at the time that Mr. LaBarre was on dual therapy.
First
and foremost, the warning label clearly cautions users that “PLAVIX
10
On the issue of efficacy, Plaintiff also relies on FDA
law and regulations on labeling requirements to support her
failure-to-warn claim. However, her reliance is misplaced,
because any violation of FDA labeling requirements is an issue of
federal law, not Florida strict liability law. See, e.g., Cook
v. MillerCoors, LLC., 872 F. Supp. 2d 1346 (M.D. Fla. 2012).
18
use with aspirin was associated with an increase in bleeding
compared to placebo with aspirin.
There was an excess in major
bleeding in patients receiving PLAVIX plus aspirin compared with
placebo plus aspirin, primarily gastrointestinal . . . sites.” See
February 2002 Plavix Labeling.
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%).
See Id., Table 3.
Plaintiff does not
dispute that this label, which was in effect when Mr. LaBarre was
prescribed the drug, warned of the particular incidence of bleeding
experienced by patients – like Mr. LaBarre – who took Plavix with
aspirin.
Rather, it appears that Plaintiff contends that those
warnings were inaccurate.
However, Plaintiff’s evidence is insufficient to establish a
genuine issue of material fact on the accuracy of the warning
label: aside from the evidence regarding the efficacy of Plavix –
which this Court has discounted – Plaintiff fails to provide any
evidence to show that the risks published on the Plavix warning
label were somehow inaccurate, insofar as the warnings concern the
risk of bleeding in ACS patients who take both Plavix and aspirin.
Indeed, some of the medical evidence upon which Plaintiff relies
indicate that when taking Plavix and aspirin in combination, there
is an increased risk of bleeding, which risks are already displayed
19
on Plavix’s warning label.
For example, Plaintiff references the
CHARISMA trial study which primarily compared the effectiveness of
long-term treatment by patients taking Plavix plus aspirin with
patients taking aspirin alone.
The study concluded that “[i]n
summary, the combination of clopidogrel plus aspirin was not
significantly more effective than aspirin alone in reducing the
rate of myocardial infraction . . . .”
See Pl. Ex. 14, p. 1714.
While the study went on to note that “the risk of moderate-tosevere bleeding was increased,” see Id., there is no indication
that the results of the study contradict those risk levels found on
the Plavix warning label.
In that regard, Plaintiff fails to
explain how the results of the CHARISMA study undermine Plavix’s
published warnings. Perhaps even more crucial is the fact that the
findings of the CHARISMA study were published in 2006 – more than
a year after Mr. LaBarre stopped taking Plavix. Therefore, those
findings cannot bolster Plaintiff’s failure-to-warn claim since
this study was not available at the time Mr. LaBarre was taking
Plavix.
In addition, Plaintiff points to an email written in 1999 by
Melvin
Blumenthal,
Executive
Director
for
Global
Clincial
Development at BMS, wherein he expressed concerns regarding higher
rates of bleeding when treating stroke patients with Plavix and
aspirin at the same time. See Blumenthal Email dated February 4,
2007.
In that connection, Plaintiff referenced an April 2004
20
email sent by Blumenthal which indicated that the outcome of the
MATCH11 study revealed that the then-Plavix warning label was
relatively “weak” regarding the risks of bleeding in patients who
suffered
ischemic
stroke
or
transient
Blumenthal Email Dated April 13, 2004.
ischemic
attack.
See
Since Mr. LaBarre did not
suffer a stroke at the time he was taking Plavix, this study is not
relevant to show that the Plavix warning label was inaccurate
regarding the risks of bleeding in patients – like Mr. LaBarre –
who suffered from ACS. Furthermore, Plaintiff does not cite to any
evidence or authority that links the results of the MATCH study to
patients with ACS. Similarly unconvincing is the June 2005 Opinion
piece published in the CHEST Journal, which highlights certain
findings regarding the use of Plavix after a coronary artery bypass
grafting. See Pl. Ex. 21. Importantly, Plaintiff does not explain
how this article and the authors’ opinion impact the accuracy of
Plavix’s warning label, other than to suggest that there is a risk
of increased bleeding when taking Plavix and aspirin - which risk
was already warned by Defendants.
Finally, the Court will discuss the opinions of Plaintiff’s
expert, Dr. Moye.
In Dr. Moye’s expert report, he opines on the
11
The MATCH study was conducted to compare the side
effects of patients who took aspirin and Plavix after recent
ischemic stroke or transient ischemic attack, with those stroke
patients who took only Plavix. See Pl. Ex. 13. Because the
study was not conducted with patients who suffer from ACS, I need
not detail the specifics of the MATCH study as it is not material
to the facts in this case.
21
efficacy of Plavix taken by patients with ACS. See Dr. Moye’s
Report p. 1.
of
Essentially, it is his opinion that due to the risks
increased
populations
bleeding
of
and low
patients,
efficacy
there
is
prescribing Plavix to those patients.
of Plavix
no
special
Id.
in
certain
benefit
from
The expert goes on to
explain certain studies preformed on Plavix, some of which were
sponsored by Defendants, e.g., CAPRIE, CURE and CREDO. His ultimate
conclusions were derived from the analyses of those studies.
Of
particular relevance, Plaintiff argues that Dr. Moye has opined
that
Plavix
is
not
effective
when
taken
long
term;
that
“identifying the optimal duration of the Plavix/[aspirin] effect is
an important public health issue in the management of ischemic
heart disease.”
report
is
any
Id. at p. 43-44.
conclusion
as
to
However, lacking in Dr. Moye’s
how
his
opinions
affect
Mr.
LaBarre’s Plavix prescription, or how Plavix’s warning label should
have reflected the duration of therapy and the impact of a long
term therapy on the risk of increased bleeding.
Moreover,
Plaintiff suggests that
Defendants
warned that Plavix is not effective for non-smokers.
should
have
Plaintiff’s
own evidence does not directly show that Plavix is ineffective on
non-smokers.
See Pl. Ex. 40, p. 2496 (clinical study noted that
the “influence of smoking status on clopidogrel metabolism is
currently being evaluated in a prospective study.”) And, Dr. Moye’s
report only states that the effect of Plavix “in nonsmokers depends
22
on the circumstances.
In those indications where Plavix has a
demonstrable effect, the effect in nonsmokers is also non-negative.
However, in patients in whom Plavix is relatively non-effective,
representing
most
of
the
ineffective in smokers.”
patient
population,
Plavix
Dr. Moye’s Report, p. 46.
remains
Clearly, this
broad statement does not stand for the proposition that Plavix is
not effective for non-smoking patients. Thus, the Court finds that
Plaintiff has not presented sufficient evidence to show that there
is a genuine issue of material fact that Plavix’s warning label was
inaccurate.
In sum, on the issue of the accuracy of Plavix’s warning
label, Plaintiff presents a number of studies and articles which
are neither relevant nor probative in demonstrating that the
warnings regarding the risks of increased bleeding in ACS patients
taking
Plavix
Significantly,
and
other
aspirin
than
were
Dr.
inaccurate
Moye’s
in
opinions,
any
which
way.
do
not
explicitly state that the Plavix warning labels were inadequate or
inaccurate, Plaintiff has not presented any other expert testimony.
Based on this reason alone, Plaintiff’s failure-to-warn claim fails
under Florida Law. Overall, Plaintiff fails, on this motion, to
adduce any relevant or credible evidence to show that Plavix’s
warning labels are somehow inaccurate, and therefore, she fails to
establish the first prong of the failure-to-warn claim.
23
B.
Causation
Because Plaintiff has not demonstrated on this motion that the
Plavix warnings were inadequate, the Court need not examine the
next prong of a failure-to-warn claim, i.e., that the inadequacy of
the
warnings
proximately
caused
the
complained-of
injury.
Nonetheless, the Court also finds that Plaintiff has failed to
raise a genuine issue of material fact as to causation.
The cardiologist, Dr. Craven, testified that he placed Mr.
LaBarre on Plavix and aspirin in 2003 and 2004 because of severe
complications related to Mr. LaBarre’s ACS.
T56:21-57:18.
See Craven Dep.,
In so doing, Dr. Craven recognized that there was a
substantial risk of bleeding in connection with placing Mr. LaBarre
on dual therapy.
See Id. at T61:6-62:20.
It was clear from Dr.
Craven’s testimony that despite the risk, he considered Plavix as
the appropriate treatment for Mr. LaBarre’s condition.
In fact,
Dr. Craven explained that without Plavix, Mr. LaBarre would have
suffered myocardial infarction or congestive heart failure, both of
which would have led to death.
Id. at T56:21-57:18.
Most
importantly, Dr. Craven affirmatively stated that even knowing that
Mr. LaBarre died of a subdural hematoma, the doctor continues to
believe that Plavix was the proper medication.
Id. at T95:24-
96:13.12
12
Plaintiff asserts that Dr. Craven’s testimony should be
given less weight because the doctor, at one point in time, was
paid by BMS as a speaker and there is a question of bias on his
24
Likewise, Plaintiff’s treating physician, Dr. Bailey, echoes
Dr. Craven’s opinions.
risk of
patients.
bleeding
Indeed, Dr. Bailey was well aware of the
when prescribing
Plavix
and
aspirin
See Dr. Bailey’s Dep., T90:15-24; T94:16-95:5.
to
her
Knowing
that risk, the doctor decided to put Mr. LaBarre on Plavix because
the benefits of that drug outweighed its risks.
14;
T116:24-117:8;
T134:6-13.
Dr.
Bailey
See Id. at T92:9concluded
in
her
deposition that even today knowing the information presented to her
by
Plaintiff,
she
would
not
“second-guess”
prescribe Plavix for Mr. LaBarre.
her
decision
See Id. at T136:11-17.
to
Indeed,
the opinions of both doctors were unequivocal: because the medical
benefits for Mr. LaBarre’s condition outweighed the risks, the
physicians were confident that the treatment they had provided for
their patient was medically necessary and appropriate. More to the
point, Drs. Craven and Bailey both represented that they would have
not changed their prescription for Mr. LaBarre even understanding
the additional risks or questions of efficacy Plaintiff has raised
in this litigation.
Accordingly, because there is no causation
evidence to support Plaintiff’s failure-to- warn claim, this claim
is dismissed.
part. However, bias, if any, on Dr. Craven’s part, would not
change the result here because, as the Court will discuss below,
Mr. LaBarre’s treating physician, Dr. Bailey, also agrees with
Dr. Craven’s medical opinion that dural therapy was the
appropriate medical treatment for Mr. LaBarre.
25
III. Florida Defective Design Claim
Plaintiff concedes that Florida, which has adopted Comment K
of Section 402A of the Restatement (Second) of Torts, precludes a
design defect claim when the “the product’s benefits . . . outweigh
its known risks as of the date of the product is distributed.”
Adams v. G.D. Searle & Co., 576 So.2d 728, 733 (Fla. Ct. App.
1991).
In other words, so long as a product is accompanied by
proper directions and warnings, Plaintiff cannot pursue the theory
of defective design. See Amore v. G.D. Searle & Co., 748 F. Supp.
845, 853 (S.D. Fla. 1990).
Therefore, having already determined
that Plaintiff is unable to establish any triable issue with
respect to her failure-to-warn claim, Plaintiff’s design claim
correspondingly fails.
IV.
Florida Manufacturing Defect Claim
To recover on a manufacturing defect claim, Plaintiff must
produce sufficient evidence on this motion to show that a mistake
in the manufacturing process occurred.
See Harduvel v. Gen.
Dynamics Corp., 878 F.2d 1311, 1317 (11th Cir. 1989); see also Cook
v. Smith, No. 04-1116, 2006 WL 580991, at *2 (M.D. Fla. Mar. 8,
2006)(no manufacturing defect under Florida law because plaintiff
offered “neither evidence nor argument to support a claim that any
alleged defect occurred during manufacture of the [product].”).
Here, no such evidence has been adduced by Plaintiff.
Indeed, the
genesis of Plaintiff’s complaints about Plavix is the drug’s anti-
26
platelet properties, which allegedly caused him 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.
V.
Negligence Claim
Plaintiff’s
negligence
claim
is
nothing
more
than
a
restatement of her defective design, defective manufacturing, and
failure-to-warn
claims.
Plaintiff
avers
that
Defendants
“negligently designed, developed, manufactured, tested, inspected,
packaged, promoted, marketed, distributed, labeled and/or sold
Plavix.”
Am. Comp., ¶ 65.
Because the Court has found that none
of her claims have merit, this claim necessarily fails.
VI.
Discovery Request Pursuant to Rule 56(d)
Finally, Plaintiff seeks additional discovery pursuant to Fed.
R. Civ. P. 56(d).
basis
to
provide
discovery.
Based on the Court’s ruling herein, there is no
Plaintiff
additional
opportunities
to
seek
Much of what Plaintiff proposes to seek relates to
Plavix’s effectiveness, which I have found to be neither relevant
nor probative of Plaintiff’s claims.
Also, Plaintiff has had the
opportunity to take the depositions of Mr. LaBarre’s treating
physicians.
As the Court has already found that these physicians’
27
testimonies do not support Plaintiff’s claim in light of the
learned intermediary
doctrine,
additional discovery
would
not
likely lead Plaintiff to any new evidence that would change the
results here.
Accordingly, the Court rejects Plaintiff’s position
that the motion is premature and further discovery should be taken.
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, 2012
/s/ Freda L. Wolfson
The Honorable Freda L. Wolfson
United States District Judge
28
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