SOLOMON v. BRISTOL-MYERS SQUIBB COMPANY et al
Filing
103
OPINION. Signed by Judge Freda L. Wolfson on 1/3/2013. (gxh)
*FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
______________________________
RONALD SOLOMON,
:
Civil Action No. 07-1102 (FLW)
Plaintiff,
:
v.
OPINION
:
BRISTOL-MYERS SQUIBB CO.,
et al.,
:
Defendants.
:
______________________________
WOLFSON, District Judge:
Plaintiff Ronald Solomon (“Plaintiff” or “Mr. Solomon”) brings
the instant suit against Defendants, Bristol Myers-Squibb Company
(“BMS”), Sanofi-Aventis U.S., L.L.C., Sanofi-Aventis U.S., Inc.,
and Sanofi-Synthelabo, Inc. (collectively, “Defendants”), alleging
that he 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 Texas state and common law
claims against Defendants, including Failure-to-Warn, Defective
Design, Manufacturing Defect and Negligence.1
1
Before the Court is
In his 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 his Complaint to assert causes of
action arising only under Texas state law. See Opinion dated
December 30, 2009, pp. 2-3. Therefore, Texas law controls on
Defendants’ motion for summary judgment based upon a number of
theories, including the learned intermediary doctrine under Texas
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
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
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.
Solomon 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., Texas, to the facts
presented in this particular case.
3
The following facts are undisputed unless otherwise
noted.
2
syndrome (“ACS”).4
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.
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
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).
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.
3
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
(0.1%), and fatal bleeding (0.2%), was the same in both
groups.
See, generally, February 2002 Plavix Labeling.
B.
Plaintiff Medical History
Plaintiff
has
a
history
of
vascular related health issues.
coronary
artery
disease
and
His first angioplasty to clear
coronary arteries occurred in 1997. See Columbia Medical Center of
San Angelo Medical Record dated July 21, 1997.
6
Plaintiff has
Table 3 of the labeling includes certain “incidence of
bleeding.”
4
undergone
at
least
seven
cardiovascular-related
surgeries
issues.
In
to
November
ameliorate
2002,
his
Plaintiff
suffered a heart attack and he was diagnosed with acute myocardial
infraction.
Summary.
See Shannon West Texas Memorial Hospital Discharge
To remediate his condition, Plaintiff’s doctors, inter
alia, placed two metal stents in his arteries to maintain blood
flow to his heart.
Id.
At that time, the interventionalist
cardiologist, Dr. Randy McCullough, prescribed Plaintiff Plavix
with aspirin in order “to prevent clots.” See Dr. McCullough Dep.,
T56:5-19.
Gene
Subsequently, Plaintiff’s treating cardiologist, Dr.
Sherrod,
and
his
clinical
nurse
specialist,
continued this prescription until July 2005.
Kim
Coon,
See Dr. Sherrod Dep,
T125:19 - 126:7.
In
July
2005,
Plaintiff
began
suffering
gastrointestinal
bleeding. See Dr. Hunt’s Examination Report dated August 5, 2005.
He was admitted to the hospital for an acute gastrointestinal
bleed, and was instructed to stop taking Plavix, but to continue
aspirin.
See Id.
After the discontinuation of Plavix, Plaintiff,
for over two months, continued to experience gastrointestinal
bleeding and was treated with blood transfusions.
Report dated September 30, 2005.
See Operative
On September 30, 2005, to stop
the chronic bleeding, Plaintiff had surgery for bowl resection,
gallbladder removal, and hernia repair.
5
Id.
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, under Texas
state law, for defective design, manufacturing defect, failure to
warn, and negligence.7
Although
these
See Am. Compl., Count I - Count IV.
claims
are
characterized
differently,
they
essentially turn on whether Defendants adequately warned that
Plavix carried 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.
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
7
On December 30, 2009, this Court dismissed Plaintiff’s
claims for negligent misrepresentation (Count V) and for
violation of the Texas Deceptive Trade Practices Act (Count VI).
See Order dated December 30, 2009.
6
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
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
7
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.
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.
Texas Failure-to-Warn Claim
Plaintiff’s theory is relatively straightforward: Defendants
failed to adequately warn Plaintiff and his prescribing physicians
8
of the potential for bleeding complications from taking Plavix.
More
specifically,
Plaintiff
insists
that
his
prescribing
physicians were not warned 1) regarding the substantial risk of
serious bleeding caused by taking Plavix with aspirin; 2) that
Plaintiff should have been genetically tested to determine his
genetic
response
to
Plavix;
3)
that
Plavix
is
entirely
inefficacious in an individual who takes the drug more than one
year after being implanted with a stent; 4) that taking Plavix is
not more effective than taking aspirin alone; and 5) that Plavix is
entirely ineffective in non-smokers.
Generally, under Texas law, a manufacturer is required to
provide an adequate warning to the end users, e.g., consumers of
its product if it knows or should know of any potential harm that
may result from the use of its product.
Centocor, Inc. v.
Hamilton, 372 S.W. 3d 140, 153-54 (Tex. 2012)(citing Bristol Myers
Co. v. Gonzales, 561 S.W. 2d 801, 804 (Tex. 1978)); Pavlides v.
Galveston Yacht Basin, Inc., 727 F.2d 330, 338 (5th Cir. 1984)
(finding that under Texas law, “a manufacturer must instruct
consumers as to the safe use of its product and warn consumers of
dangers of which it has actual or constructive knowledge at the
time the product is sold.”). In certain situations, however, “the
manufacturer’s
or
supplier’s
duty
to
warn
end
users
of
the
dangerous propensities of its product is limited to providing an
adequate warning to an intermediary, who then assumes the duty to
9
pass the necessary warnings on to the end users.”
Centocor, 372
S.W. 3d at 154. Specifically within the prescription drug context,
“where a plaintiff sues the manufacturer of a prescription drug for
failing to adequately warn of the drug’s effects, Texas courts
employ the learned-intermediary doctrine.”
Pustejovsky v. PLIVA,
Inc., 623 F.3d 271, 276 (5th Cir. 2010)(citing Alm v. Aluminum Co.
of Am., 717 S.W.2d 588, 591 (Tex. 1986)).8
As the Texas Supreme Court has explained, “the underlying
premise for the learned intermediary doctrine is that prescription
drugs are complex and vary in effect, depending on the unique
circumstances of an individual user, and for this reason, patients
can obtain them only through a prescribing physician.”
372 S.W.3d at 154.
Centocor,
The Court went on to state that “the bedrock of
[the] healthcare system is the physician-patient relationship, and
the ultimate decision for any treatment rests with the prescribing
8
Plaintiff implores this Court to reject the learned
intermediary doctrine when examining Texas 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 Texas law controls in this
case, this Court, sitting in diversity, is bound to follow state
law as announced by the highest court in Texas. See Nuveen Mun.
Trust v. Withumsmith Brown, P.C., 692 F.3d 283, 315 (3d Cir.
2012). And, the Texas Supreme Court has recently reaffirmed the
viability and application of the learned intermediary doctrine in
Centocor in the context of prescription drugs. See Centocor, 372
S.W. 3d at 154. In so holding, the Texas Court considered, and
rejected, the reasoning espoused by the West Virginia Supreme
Court.
10
physician and the patient. As a matter of both necessity and
practicality, the duty to warn the patient of the potential risks
and possible alternatives to any prescribed course of action rests
with the prescribing physician.”
Id. at 166.
For these reasons,
the Court held that “in most prescription drug contexts, the
learned intermediary doctrine applies and the duty to warn the
patient rests solely with the prescribing physician.” Id. at 167.
Indeed, a patient’s doctor, who stands between the patient and the
manufacturer, is in the best position to professionally evaluate
the patient's needs, assess the risks and benefits of available
drugs, prescribe one, and supervise its use. See Ackermann v. Wyeth
Pharms., 526 F.3d 203, 207 (5th Cir. 2008).
Hence, “[i]f the
doctor is properly warned of the possibility of a side effect and
is advised of the symptoms normally accompanying the side effect,
it is anticipated that injury to the patient will be avoided.” Id.
Recognizing the doctor-patient relationship, the doctrine excuses
a drug manufacturer “‘from warning each patient who receives the
product
when
the
manufacturer
properly
physician of the product’s dangers.’”
warns
the
prescribing
Id. (quoting Porterfield v.
Ethicon, Inc., 183 F.3d 464, 467-68 (5th Cir. 1999)).
In Texas, to recover for failure to warn under the learned
intermediary doctrine, a plaintiff must show that (1) the warning
was defective, and (2) the failure to warn was a producing cause of
the injury.
Ackerman, 526 F.3d at 208.
11
Worded differently, “a
plaintiff
who
complains
that
a
prescription
drug
warning
is
inadequate must also show that the alleged inadequacy caused the
doctor to prescribe the drug.”
McNeil v. Wyeth, 462 F.3d 364, 372
(5th Cir. 2006) (internal quotations omitted). This is because
under the learned intermediary doctrine, if the doctor was “‘aware
of the possible risks involved in the use of the product but
decided to use it anyway, the adequacy of the warning is not a
producing cause of the injury’ and the plaintiff's recovery must be
denied.” Ackerman, 526 F.3d at 208 (quoting Porterfield, 183 F.3d
at 468).
“Even if the physician is not aware of a risk, the
plaintiff must show that a proper warning would have changed the
decision
of
the
treating
physician,
i.e.,
that
but
for
the
inadequate warning, the treating physician would have not used or
prescribed
the
product.’”
Id.
(citations
and
quotations
omitted)(emphasis added); see Dyer v. Danek Med., Inc., 115 F.
Supp. 2d 732, 741 (N.D. Tex. 2000); Willett v. Baxter Int'l, Inc.,
929 F.2d 1094, 1099 (5th Cir. 1991); see also Burton v. Am. Home
Prods. Corp., 955 F. Supp. 700, 710-11 (E.D. Tex. 1997).
To be
clear, the learned intermediary is not an affirmative defense and
therefore, the burden of proof always lies with the plaintiff to
establish that the complained-of warning was defective and that the
failure to properly warn was a producing cause of the injury.
Ebel
v. Eli Lilly & Co., 321 Fed. Appx. 350, 355 (5th Cir. 2009);
Centocor, 372 S.W. 3d at 164.
12
Before I discuss the application of the learned intermediary
doctrine, I first address Plaintiff’s argument regarding the “Read
and Heed” presumption.
Plaintiff contends that he is entitled to
a heeding presumption that proper warnings would have a made a
difference and that this presumption excuses him from proving
causation.
However, Texas law creates no such presumption.
The
Fifth Circuit, in Ackerman, made clear that “neither Texas nor
federal courts applying Texas law have applied the read-and-heed
presumption
to
intermediaries.”
pharmaceutical
cases
involving
Ackerman, 526 F.3d at 212.
learned
Indeed, the court
explained that “Texas has explicitly rejected the Restatement
(SECOND) Of Torts § 402A, Comment j's ‘read-and-heed’ presumption
for
policy
reasons
and
because
it
has
been
superseded
Restatement (THIRD) Of Torts::Products Liability § 2.”
by
Id. at 213
(citing Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328,
336-37 (Tex. 1998)); Koenig v. Purdue Pharma Co., 435 F. Supp. 2d
551,
556-57
(N.D.
Tex.
2006)(stating
expressly
that
the
read-and-heed presumption does not apply in cases involving learned
intermediaries).
Furthermore, the Fifth Circuit predicted that
the Texas Supreme Court is unlikely to apply the “Read and Heed”
presumption involving learned intermediaries.
at 213.
Ackerman, 526 F.3d
And, Plaintiff has not provided the Court with any recent
authority that would suggest otherwise.
13
Accordingly, contrary to
Plaintiff’s position, the Court will not apply such presumption in
this case.
A.
I now turn to the learned intermediary doctrine.
Accuracy of Plavix’s Warning Label
Plaintiff’s failure-to-warn claim fails because the learned
intermediary doctrine excuses Defendants from liability in this
case.
As noted above, Plaintiff complains that Defendants did not
adequately warn about the substantial risk of serious bleeding
caused by taking Plavix with aspirin, that Plavix is ineffective
for a non-smoker, and that Plavix loses its efficacy for patients
who take the drug for more than one year after being implanted with
stents.
Indeed, Plaintiff dedicates much of his 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 Plaintiff’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
ischemic stroke events.
patients
with
recurrent
transient
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.
14
Plaintiff credits
Defendants’ aggressive marketing as the reason why physicians
continue
to
efficacy.
prescribe
See
Pl.
Plavix
Ex.
in
28.
the
absence
Notwithstanding
of
evidence
this
of
position,
Plaintiff, however, did not suffer from transient ischemic stroke.
Thus, this study is irrelevant to Plaintiff’s claim.
In fact, the majority of the efficacy studies of Plavix cited
by Plaintiff are unrelated to Plaintiff’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.
However, Plaintiff was not treated with Plavix after
his
operation,
bypass
rather
he
was
treated
with
stents.
Similarly, the studies upon which Plaintiff rely regarding Plavix’s
ineffectiveness for patients 75 years or older has no relevance
since Plaintiff was well under 75 years old when he stopped taking
the drug.
See Watson Cert., Ex. E. Another glaring example is
Plaintiff’s reliance on studies that have found that Plavix, when
taken alone, is not more effective than taking aspirin by itself.
See Pl. Exs. 5, 7.
As Plaintiff concedes, however, he 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, the studies based on the efficacy of
15
Plavix, as presented by Plaintiff on this motion, fail to raise a
genuine issue of material fact on the question of whether Plavix’s
warnings were adequate.9
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 Texas, 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 any danger
or harm that may result from ingesting the drug.
See Reese v.
Mercury Marine Div. of Brunswick Corp., 793 F.2d 1416, 1420 n.1 (5th
Cir. 1986).
Permitting Plaintiff to pursue his failure-to-warn
claim on an efficacy theory would, as has been found in other
jurisdictions with similar laws, impermissibly expand liability
under Texas law on the adequacy of pharmaceutical warning labels.
See, e.g., 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
9
Furthermore, as discussed infra, if the studies are not
relevant to Plaintiff’s condition, then the failure to inform the
physicians of such findings cannot establish causation.
16
law.”); 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).
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
explicated
earlier,
time
Plaintiff
was
in
prescription
on
drug
dual
therapy.
As
cases
involving
the
learned intermediary doctrine, Texas law is clear: when “a warning
specifically mentions the circumstances complained of, the warning
is adequate as a matter of law.”
Rolen v. Burroughs Wellcome Co.,
856 S.W. 2d 607, 609 (Tex. App. 1993).
In that connection, in
cases where the dispute lies with the particular risk level that a
warning label publishes, the plaintiff must present sufficient
evidence to demonstrate that the published risk level is inaccurate
or misleading. Id.; Murthy v. Abbott laboratories, 847 F.Supp. 2d
958, 968 (S.D. Tex. 2012).
For instance, "[w]arning the learned
intermediary of a much lower risk than the actual risk could render
the warning not just misleading, but ineffective." Id. "Thus, if
the manufacturer decides to label a risk as 'comparatively rare'
17
and also to provide a numerical quantification of that risk, that
number must be within a certain degree of accuracy." Id.
In this case, first and foremost, the warning label clearly
cautions users that “PLAVIX 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%).
Table 3.
See Id.,
Plaintiff does not dispute that this label, which was in
effect when he was prescribed the drug, warned of the particular
incidence of bleeding experienced by patients – like Plaintiff –
who took Plavix
with
aspirin.
Rather,
it
appears
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 risk levels published on the Plavix
warning label were inaccurate, insofar as the warnings concern the
risk of bleeding in ACS patients who take both Plavix and aspirin.
18
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
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 – a year
after Plaintiff stopped taking Plavix. Therefore, those findings
cannot bolster Plaintiff’s failure-to-warn claim since this study
was not available at the time Plaintiff 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
19
aspirin at the same time. See Blumenthal Email dated February 4,
2007.
In that connection, Plaintiff referenced an April 2004
email sent by Blumenthal which indicated that the outcome of the
MATCH10 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 Plaintiff did not
suffer a stroke at the time he was taking Plavix, this study has no
relevance in showing that the Plavix warning label was inaccurate
regarding the risks of bleeding in patients – like Plaintiff –
suffer from ACS.
who
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.
after
the
See Pl. Ex. 21.
placement
of
As noted earlier, Plaintiff took Plavix
stents
-
not
bypass
surgery.
More
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
10
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 immaterial
to the issues in this case.
20
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
efficacy of Plavix taken by patients with ACS. See Dr. Moye’s
Report p. 1.
of
increased
Essentially, it is his opinion that due to the risks
bleeding
and low
efficacy
of Plavix
in
certain
populations of patients, there is no special benefit of prescribing
Plavix to those patients.
Id.
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.”
Id. at p. 43-44.
However, lacking in Dr. Moye’s
report is any conclusion as to how his opinions affect Plaintiff’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 should have warned that Plavix is not
21
effective for non-smokers.11
As Plaintiff is aware, his own
evidence does not conclusively 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
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 cannot find
that Plaintiff has 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 and aspirin were inaccurate in any way.
11
Despite
Plaintiff conceded that he smoked as much as three or
four packs a day until 1978, see Solomon Dep., T48:4-12, and that
at the time Plaintiff was taking Plavix, he was also using oral
tobacco products. See McCullough Dep. at T31:23-32:2.
22
Plaintiff’s assertion to the contrary, “determining that a party
has failed to established an essential element of the claim is a
proper consideration on summary judgment and is not a finding of
fact to be left to the jury.”
Ebel, 321 Fed. Appx. At 357.
Therefore, without adducing evidence to show that the specific risk
levels referenced in Plavix’s warning label are somehow inaccurate,
Plaintiff fails on this motion to establish the first prong of his
failure-to-warn claim.
B.
Causation
In addition to proving inaccuracy, Plaintiff has to show that
the allegedly defective warning label is the producing cause of
Plaintiff’s injury.
See Ackerman, 526 F.3d at 208. Simply put, it
is Plaintiff’s burden to demonstrate that the treating physician
would
not
have
inadequate
used
warning.
or
prescribed
Having
the
reviewed
product
but
Plaintiff’s
for
the
treating
physicians’ testimony, the Court finds that Plaintiff has also
failed to carry his burden on this prong.
As
the
Plaintiff
interventionalist,
was
placed
on
Dr.
Plavix
and
McCullough
aspirin
testified
in
2002
Plaintiff “has demonstrated he has multivessel disease.
that
because
In other
words, it not only involved his heart, he had to have bypass
surgery; but he’s also had what sounds like an arterial embolus, a
piece of material either a clot or a piece of plaque or blockage
that’s broken loose and gone to . . . the arteries feeding his
23
colon; he had to have his colon removed.
arteries
in
his
neck
had
arteriosclerotic disease.”
to
be
And he’s had – both
operated
on
because
of
Dr. McCullough’s Dep., T28:16-24.
In
addition, Dr. McCullough 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., T49:1350:2. The doctor determined that placing Plaintiff on dual therapy
with Plavix and aspirin indefinitely was the best treatment at the
time.
Indeed, Dr. McCullough was aware that there were risks
associated with this type of treatment.
He explained: “The thing
that we’re giving the medication for is to – for the prevention of
blood clots.
So any time you give a medication that can prevent
blood clots, its going to increase the risk of bleeding as well; or
. . . some blood loss.”
Id., T63:2-9.
Importantly, Dr. McCullough
acknowledged that dual therapy could cause serious risk of bleeding
in patients.
Id., T63:1-10.
However, the cardiologist insisted
that despite the risks, it was important that these drugs were
prescribed to Plaintiff to prevent “a condition called subacute
thrombosis.
And
it is
a life-threatening
problem
that
will
actually cause the blockage – that artery to block off by a clot if
it happens. And I’ve seen it happen on cessation of aspirin and/or
Plavix; even sometimes beyond the recommended dose interval.” Id.,
T64:13-20.
In fact, Dr. McCullough goes so far as to explain that
the standard of medical practice today, let alone in 2002, is to
24
provide the combination of Plavix and aspirin for patients like
Plaintiff.
Id., T65:18-23.
Furthermore,
throughout
Dr.
McCullough’s
deposition,
he
consistently testified that he did not rely on Plavix warning
labels when putting Plaintiff on dual therapy with Plavix and
aspirin.
See Id. T58: 8-17.
Dr. McCullough explained:
Well, of course, you know these drugs are studied by researchminded interventional cardiologists all over the world, and so
our publications and things that we read . . . our so called
trade journals, plus articles that come out. [T]hat’s how they
come up with the new recommendations of how you treat . . . .
I would say most of really . . . pay attention to what our
colleagues in the research realm are doing, and those are
where our recommendations come from.
Id., T58:8-59:4.
Essentially, Dr. McCullough represented that he
typically relies on guidelines from the medical community and his
colleagues’
opinions
rather
prescribes to patients.
than
the
labels
for the
drug
he
Id., T61:3-11; T86:13-21 (“I’m not really
depending on the drug company . . . . As I said, this is more
information we get from so-called trade journals, like JACC, the
interventional journals as well as . . . updated things for our
societies.”); T91:4-20 (“And again, the people that I get my
recommendations
themselves.
from
really
are
not
from
the
drug
companies
I mean, I don’t . . . talk to physicians at the drug
companies . . . . I try to learn what I need to learn from my
colleagues and the people that are doing the same thing that I’m
doing that actually do the research.”).
25
Ultimately, Dr. McCullough reiterated that he would not have
prescribed anything different to Plaintiff knowing what he knows
about Plavix today:
Q:
Based on what you’ve seen today in Mr. Solomon’s records,
and the information regarding his history, what you found
during the cath and what you did during the cath, do you
believe that your prescription of Plavix and aspirin to
him was appropriate?
A:
Yes, I do.
Q:
If he presented today to you with all the signs and
symptoms and history that we saw in his records today, do
you think you would place him on Plavix and aspirin
today?
A:
There are several options now, but yes.
*
Q:
*
*
Do you believe your patients have benefitted from taking
Plavix and aspirin following stent placement?
A:
I believe that to be true . . . It may have prevented
them from having a life threatening event, I would say.
Id., T110:3-112:20.
Likewise, Plaintiff’s treating physician, Dr. Sherrod, echoes
Dr. McCullough’s opinions.
Indeed, Dr. Sherrod was well aware of
the risks of bleeding when prescribing Plavix and aspirin to his
patients.
See Dr. Sherrod’s Dep., T39:3-22.
26
In fact, the doctor
stated that the medical community knew about the significant
bleeding risk “ever since [Plavix] came out.”
Id., T40:1-3.
However, Dr. Sherrod acknowledged that while he “understand[s] that
there’s risk to giving [Plavix and aspirin] when we give it, and
the patient understands that there’s a risk . . . [of] bleeding. .
. but if you stop it, you have a high risk, or a significant risk
of having something bad happen to you.
benefits
are
–
outweigh
the
risks.
Because I think the
Like
I
said,
periodically you have a disaster, and it can be bad.”
though,
Id., T42:6-
13; see Id., T47:23-4812; T72:14-73:7. Dr. Sherrod, like Dr.
McCullough,
received,
and
continues
to
receive,
information
regarding potential risks and benefits of a particular drug from
“things on the internet . . . available through clinic and through
the hospital
that
pulls
information,
prescribing
information,
doses, indications, complications, adverse reactions, interactions
with other medications.” Id., T50:2-9. Significantly, Dr. Sherrod
also represented that based on the information regarding Plavix at
this time, it would not have changed his medical decision to place
Plaintiff on dual therapy; in fact, Dr. Sherrod commented that it
is “pretty standard” and “medically appropriate” to prescribe
Plavix and aspirin for Plaintiff’s condition. Id., T108:14-109:8.12
12
Nurse Coon was under the supervision of Dr. Sherrod.
Without delving into the specifics of her testimony, Nurse Coon’s
statements regarding the risks of taking Plavix and aspirin, as
well as whether dural therapy was the appropriate treatment for
Plaintiff at the time, were consistent with those statements made
27
As this Court has stressed, Texas law is clear on causation:
“when the prescribing physician is aware of the product’s risks and
decides to use it anyway, any inadequacy of the product’s warning,
as a matter of law, is not the producing cause of the patient’s
injuries.”
Centocor, 372 S.W. 3d at 170.
Under this scenario,
“where a physician testifies that he [or she] was aware of the
risks of which plaintiff complains, it is then the plaintiff’s
burden to prove that a different warning would have changed the
physician’s decision to prescribe the medication.”
and quotations omitted).
Id.(citations
It is clear from the above-testimony of
both Drs. McCullough and Sherrod that they were aware of the
serious risks of bleeding when placing Plaintiff on dual therapy
with Plavix and aspirin.13
Indeed, the opinions of both doctors
by Drs. McCullough and Sherrod. See, e.g., Coon’s Dep., T58:47; T42:13-43:9; T43:23-44:2; T54:3-55:3; T121:16-21.
13
Plaintiff cites to different parts of Dr. McCullough’s
deposition and argues that had the doctor known that Plavix was
ineffective and of particular risk to Plaintiff, Dr. McCullough
would not have prescribed the drug. See Pl. Opp. Br., pp. 19-20.
However, not only does the testimony to which Plaintiff refers
fail to support his position, Plaintiff misconstrues Dr.
McCullough’s answers. For example, Plaintiff’s counsel asked Dr.
McCullough whether it would affect his decision if BMS published
information concerning the lack of efficacy of Plavix with the
use of stents after one year. During the testimony, the doctor
responded that he was not aware of BMS publishing any information
on that subject. See McCullough’s Dep., T96:2-11. Instead of
citing to this answer, Plaintiff, in his Opposition, cites a
different part of the doctor’s testimony which clearly is not
responsive to the question posed. Even more troubling, some of
Plaintiff’s citations to the testimony are incomplete and thus,
misleading. See, e.g., Pl. Opp. Br., p. 19.
28
were unequivocal: because the medical benefits for Plaintiff’s
condition outweighed the risks, the physicians were confident that
the
treatment
they
had
necessary and appropriate.
provided
for
Plaintiff
was
medically
In response, Plaintiff has produced no
evidence – testimonial or otherwise – to suggest that a different
warning would have led these doctors to alter their treatment for
Plaintiff.14
See
Centocor,
372
S.W.
3d
at
171.
Even
more
importantly, Drs. McCullough and Sherrod both represented that they
would have not changed their prescription for Plaintiff even
understanding
the
additional
risks
or
Plaintiff has raised in this litigation.
questions
of
efficacy
Accordingly, because
there is no causation evidence to support Plaintiff’s failure-towarn claim, this claim is dismissed.
C.
Statutory Rebuttable Presumption - FDA Approved Labels
Plaintiff’s failure-to-warn claim fails for the additional
reason that, under Texas law, Defendants are presumed not liable
because the Plavix warning labels were approved by the FDA.
In
Texas, where prescription drug manufacturers comply with the FDA
regulations, Texas law creates a rebuttable presumption of nonliability in prescription drug suits.
Code.
Ann.
§
82.007;
Lofton
v.
14
See Tex. Civ. Prac. & Rem.
McNeil
Consumer
&
Specialty
Moreover, Plaintiff has not presented any objective
evidence that a different warning would have affected the
decision of a reasonable doctor to prescribe Plavix and aspirin
for Plaintiff’s condition.
29
Pharmaceuticals, 672 F.3d 372, 374 (5th Cir. 2012); Phares v.
Actavis-Elizabeth, LLC, No. 11-63, 2012 U.S. Dist. LEXIS 123858, at
*17-18 (S.D. Tex. Aug. 30, 2012).
Section 82.007 provides, in relevant part:
(a) In a products liability action alleging that an
injury was caused by a failure to provide adequate
warnings or information with regard to a pharmaceutical
product, there is a rebuttable presumption that the
defendant or defendants, including a health care
provider, manufacturer, distributor, and prescriber, are
not liable with respect to the allegations involving
failure to provide adequate warnings or information if:
(1) the warnings or information that accompanied
the product in its distribution were those
approved by the United States Food and Drug
Administration for a product approved under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Section 301 et seq.), as amended, or Section 351,
Public Health Service Act (42 U.S.C. Section 262),
as amended; or
(2) the warnings provided were those stated in
monographs developed by the United States Food and
Drug Administration for pharmaceutical products
that may be distributed without an approved new
drug application.
(b) The claimant may rebut the presumption in Subsection
(a) as to each defendant by establishing that:
(1) the defendant, before or after pre-market
approval or licensing of the product, withheld
from or misrepresented to the United States Food
and Drug Administration required information that
was material and relevant to the performance of
the product and was causally related to the
claimant's injury . . . ;
Tex. Civ. Prac. & Rem. Code. Ann. § 82.007(a) and (b).
Where a fact is a “presumption” or “presumed,” it means that
“the trier of fact must presume the existence of the fact unless
30
and until evidence is introduced to support a finding of its
nonexistence.”
Com.
Code
Murthy, 847 F.Supp. 2d at 973(citing Tex. Bus. &
Ann.
§
1.201(b)(29)).
Therefore,
the
effect
of
a
presumption “is to shift the burden of producing evidence to the
party against whom it operates.”
omitted).
In
order
to
Id. (citations and quotations
rebut the statutory
presumption,
the
plaintiff has to present sufficient evidence to demonstrate that
the defendant defrauded the FDA and that the FDA, itself, has also
found fraud on the part of the drug manufacturer.
Lofton, 672 F.3d
at 380.
Here,
Plaintiff’s
Complaint
complied with the FDA standards.
assumes
Defendants’
warnings
In fact, there is no dispute that
the Plavix warnings were approved by the FDA.
Although Plaintiff
suggests that the FDA has “privately expressed doubts to the
Defendants that there is any benefit to Plavix use after three
months,” see Pl. Opp. Brief, p. 9, Plaintiff presents no evidence,
nor does he even argue, that Defendants defrauded the FDA in any
way. Moreover, there is no evidence of any kind establishing that
the FDA has found fraud on the part of Defendants in connection
with the Plavix warning labels.
Indeed, the bulk of Plaintiff’s
case against Defendants is premised upon the fact that there is
competing scientific evidence to suggest that Plavix is ineffective
under certain
circumstances
in
patients
and
that there
is a
substantial risk of bleeding when taking both Plavix and aspirin at
31
the same time.
Absent any evidence to show “fraud on the FDA,”
Plaintiff fails to rebut the presumption, and such failure is fatal
to his failure-to-warn claim.
Based on this reason alone, such a
claim cannot survive summary judgment. See Phares, 2012 U.S. Dist.
LEXIS 123858, at *19-20 (“Since the Texas non-liability presumption
applies
.
.
.
Plaintiff’s
failure
to
warn
claims
must
be
dismissed.”); Murthy, 847 F. Supp. 2d at 976 (dismissing the
plaintiff’s failure-to-warn claims since the plaintiff failed to
rebut the statutory presumption under § 82.007(a)); Anderson v.
Abbott Labs., No.11-1825, 2012 U.S. Dist. LEXIS 141585, at *10-11
(N.D. Tex. Sep. 30, 2012)(same).
Accordingly, Plaintiff failure-to-warn claim is summarily
dismissed.
III. Texas Defective Design Claim
Plaintiff concedes that Texas permits a design defect claim
only “premised on a failure to warn.”
Ebel v. Lilly & Co., 536
F.Supp. 2d 767, 773 (S.D. Tex. 2008); Centocor, 372 S.W. 3d at 173;
Hackett v. G.D. Searle & Co., 246 F.Supp. 2d 591, 595 (W.D. Tex.
2002)
(citing
Restatement
(Second)
Torts
§
402A,
comment
k)
(holding that prescription drugs are not susceptible to a design
defect claim where, as here, the drug is “accompanied by proper
directions and warning.”). In this case, having already determined
that Plaintiff is unable to establish any triable issue with
respect to his failure-to-warn claim, Plaintiff’s design claim
32
correspondingly fails.
See Holland v. Hoffman-La Roche, Inc., No.
06-1298, 2007 U.S. Dist. LEXIS 84507, at *8 (N.D. Tex. Nov. 15,
2007).
IV.
Texas Manufacturing Defect Claim
To sustain a claim for manufacturing defect, Plaintiff must
produce
sufficient
evidence
on
this
motion
to
show
that
by
ingesting Plavix, Plaintiff suffered from “a manufacturing flaw
which render[ed] the product unreasonably dangerous.”
Hoffman-La
Roche,
Inc.,
392
F.Supp.
2005)(citation and quotations omitted).
2d
907,
922
Gerber v.
(S.D.
Tex.
In that regard, Plaintiff
must prove that the drug deviated “in its construction or quality,
from the specifications or planned output in a manner that renders
it unreasonably dangerous.” Ford Motor Co. v. Ridgway, 135 S.W. 3d
598, 600 (Tex. 2004).
Plaintiff.
Here, no such evidence has been adduced by
Indeed, the genesis of Plaintiff’s complaints about
Plavix is the drug’s anti-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 his 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.
33
V.
Negligence Claim
Plaintiff’s
negligence
claim
is
nothing
more
than
a
restatement of his 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., ¶ 69.
Because the Court has found that none
of his claims have merit, this claim necessarily fails.
VI.
Discovery Request Pursuant to Rule 56(d)
As a final note, Plaintiff seeks additional discovery pursuant
to Fed. R. Civ. P. 56(d).
Based on the Court’s ruling herein,
there is no basis to provide Plaintiff additional opportunities to
seek discovery. Aside from Plaintiff’s dispute centered around the
accuracy of the Plavix warning label, Plaintiff has failed to rebut
the
statutory
presumption
of
non-liability
law.
In
that
connection, because Plaintiff has neither suggested nor provided
any evidence that the FDA was defrauded in any way, additional
discovery would not cure Plaintiff’s deficiencies.
of
what
Plaintiff
proposes
to
seek
relates
Moreover, much
to
Plavix’s
effectiveness, which I have found to be neither relevant nor
probative of Plaintiff’s claims.
take
the
Also, Plaintiff has had the
opportunity
to
depositions
of
Plaintiff’s
treating
physicians.
As the Court has already found that these physicians’
testimonies do not support Plaintiff’s claim in light of the
34
learned intermediary
doctrine,
additional discovery
would
not
likely lead Plaintiff to any new evidence that would change the
results here. Accordingly, Plaintiff’s position that the motion is
premature and further discovery should be taken is without merit.
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 3, 2013
/s/ Freda L. Wolfson
The Honorable Freda L. Wolfson
United States District Judge
35
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