Armantrout et al v. Bristol-Myers Squibb Company et al
OPINION filed. Signed by Judge Freda L. Wolfson on 8/17/2017. (km)
*NOT FOR PUBLICATION*
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
IN RE: PLAVIX MARKETING, SALES
PRACTICES AND PRODUCTS LIABILITY
LITIGATION (NO. II)
MDL No. 2418
This Document Relates to:
Civ. Action No.: 134521(FLW)
GARY ARMANTROUT, et al.,
BRISTOL-MYERS SQUIBB, et al.,
WOLFSON, District Judge:
This matter is a member case to the Multi-District Litigation
(“MDL”) entitled, In Re: Plavix Marketing, Sales Practices and
Plaintiff Roger Hopkins (“Plaintiff” or “Hopkins”) 1
brings the instant suit against Defendants, Bristol Myers-Squibb
Company (“BMS”), Sanofi-Aventis U.S., L.L.C., Sanofi-Aventis U.S.,
Plaintiff’s wife, Donna Hopkins, a co-plaintiff in this case,
also brought a loss of consortium claim. But, for the purposes of
this motion, I will refer only to Plaintiff Roger Hopkins, as all
other claims concern him.
Inc., and Sanofi-Synthelabo, Inc. (collectively, “Defendants”),
alleging that he suffered injuries as a result of Defendants’
distributing, labeling and sale of their prescription drug Plavix,
an anti-clotting medication. Plaintiff’s Complaint asserts various
New York state and common law claims against Defendants, including
Negligence and Loss of Consortium. Before the Court is Defendants’
motion for summary judgment based upon a number of theories,
including the learned intermediary doctrine under New York law.
Plavix is a drug that inhibits blood platelets from forming
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 arterial disease.
See Defs. Statement, ¶
Thereafter, the FDA approved Plavix for dual therapy with
treatment of patients with particular types of acute coronary
syndrome (“ACS”). 3 Id. at ¶ 3.
The following facts are not in dispute unless otherwise noted.
ACS is a set of clinical signs and symptoms occurring when
the heart muscle does not receive enough blood because of plaque
Taking Plavix is not without risk.
Because it functions by
inhibiting the formation of blood clots, it is well known that
Plavix increases the risk of bleeding.
In that connection, when
information on that risk. When Plaintiff was using Plavix in 2003,
the drug label provided:
The use of PLAVIX is contraindicated in the following
. . .
Active pathological bleeding such as peptic
ulcer or intracranial hemorrhage.
* * *
[PLAVIX] prolongs the bleeding time and therefore
should be used with caution in patients who may be at
risk of increased bleeding from trauma, surgery, or
other pathological conditions (particularly
gastrointestinal and intraocular). If a patient is to
undergo elective surgery and an antiplatelet effect is
not desired, PLAVIX should be discontinued 5 days
prior to surgery.
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).
Due to the risk of bleeding and undesirable
hematological effects, blood cell count determination
and/or other appropriate testing should be promptly
considered, whenever such suspected clinical symptoms
arise during the course of treatment (see ADVERSE
GI Bleeding: In CAPRIE, 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. Patients should inform physicians and
dentists that they are taking PLAVIX before any
surgery is scheduled and before any new drug is taken.
* * *
Hemorrhagic: In CAPRIE patients receiving PLAVIX,
gastrointestinal hemorrhage occurred at 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
. . .
In CURE, PLAVIX use with aspirin was associated with
an increase in bleeding compared to placebo with
aspirin (see Table 3). 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.
In patients receiving both PLAVIX and aspirin in CURE,
the incidence of bleeding is described in Table 3.
Defs’ Facts, ¶ 5.
Plaintiff’s Medical History
Hopkins is a 69 year old man from Rochester, New York.
Henry Richter, Plaintiff’s cardiologist and prescribing physician,
explained that Mr. Hopkins had several “cardiac risk factors” that
contributed to the risk of him having a heart attack. See Richter
Dep. at T27:11-28:12; T28:23-T30:2.
These included diabetes, a
Id. at T27:19-24.
In June 2000, Hopkins suffered from acute chest pain, often
Richter’s Dep. at T27:11-28:12.
placed Hopkins on aspirin.
Richter Dep. at T31:7-15.
Consequently, Hopkins’ doctor
See Hopkins Dep. at T92:24-T94:5;
Hopkins, again, was presented with
unstable angina in October 2000. See Richter Dep. at T27:11-T28:12.
Three years later, in June 2003, Hopkins experienced a third
instance of unstable angina which required hospitalization.
id. at T31:20-T32:11.
Based on his medical history, Hopkins’
doctors determined that he required a stent.
See id. at T32:12-
As a result of the particular type of stent that Hopkins
received, Dr. Richter put Hopkins on double antiplatelet therapy,
which included aspirin and Plavix.
See id. at T34:25-T35:4.
Plaintiff took Plavix for the next eight years, without suffering
a heart attack.
See id. at T47:5-13.
See Karthikeyan Dep. at T19:20-T20:9.
His doctors performed an endoscopy, which found a hiatal hernia
and two ulcers.
It is unclear from the record as to the cause of
these conditions, but according to Hopkins, the excessive bleeding
was due to taking Plavix, and he was advised to discontinue taking
After discontinuing Plavix, Mr. Hopkins suffered a heart
attack in and around October 2016.
Due to the gastrointestinal bleeding allegedly resulting from
Defendants asserting product liability related causes of action,
under New York state law, for defective design, manufacturing
defect, failure to warn, negligence and loss of consortium.
III. Dr. Richter’s Testimony
In that connection, Dr. Richter explained
that he was well aware of the risk of increased bleeding associated
with taking Plavix, as well as with the dual therapy.
And what is the principal risk of antiplatelet agents
[such as Plavix]?
And is -- do antiplatelet agents carry the risk of
bleeding because they -- they work, in effect, by inhibiting
That is true.
And so this is a potential risk of any antiplatelet --
antiplatelet agent; is that correct?
That is true.
And is it fair to say that you understood throughout the
time that you prescribed Plavix in your practice that it
carried with it a bleeding risk?
The same is true for aspirin, right?
understand that that would lead to an increased risk of
bleeding because you have two antiplatelet agents?
That's been studied and that is definitely true.
Richter Dep. at T15:23-T16:20.
Dr. Richter went on to testify that, knowing such risks, he
medically needed such drugs.
And, did you, on occasion, for appropriate patients
prescribe Plavix throughout the time that you were practicing
at the University of Rochester say in the years 2002 to when
you left your practice?
You found that it was a useful medication for appropriate
More than useful.
Id. at T16:21-T17:4.
In particular, Dr. Richter testified that
with the specific type of stent that Plaintiff received, “the
community of interventional cardiologists at that time with this
particular stent, the CYPHER stent advocated using aspirin and
Plavix for the duration of the life of the patient.”
And, indeed, Dr. Richter felt that dual therapy was
needed in light of Plaintiff’s condition and stent placement.
Importantly, Dr. Richter made a medical assessment
that “the benefits [of dual therapy] outweighed the risk at that
Id. at T35:20-21.
To this day, Dr. Richter continues to believe that Plavix was
the proper prescription for Hopkins:
[S]itting here today, you believe that your prescription
to Mr. Hopkins of Plavix during the period that you treated
him was appropriate medical therapy for him?
Id. at T51:16-20.
This action, originally filed in Illinois state court, was
removed by Defendants to the United States District Court for the
Northern District of Illinois.
Once removed, the matter was
transferred to this MDL litigation by the MDL Panel.
Defendants filed the instant motion for summary judgment on
May 19, 2017, and Plaintiff has opposed the motion. 4
held oral argument on June 27, 2017, wherein the parties’ counsel
During the hearing, Plaintiff’s counsel, Ms. Diane
manufacturing defect claim, and as such, that claim is dismissed.
See Motion Tr. T4:22-T5:2.
Counsel further conceded that the
negligence and strict liability claims with regard to the duty to
warn, involve the same analysis.
See id. at T5:4-13.
Accordingly, on this motion, I will address Plaintiff’s failure to
warn and design defect claims.
depositions, answers to interrogatories, and admissions on file,
together with the affidavits, if any, show that there is no genuine
The parties agree that New York law applies to Plaintiff’s
issue as to any material fact and that the moving party is entitled
to a judgment as a matter of law.” Fed. R. Civ .P. 56(c). A factual
dispute is genuine only if there is “a sufficient evidentiary basis
on which a reasonable jury could find for the non-moving party,”
and it is material only if it has the ability to “affect the
outcome of the suit under governing law.” Kaucher v. County of
Bucks, 455 F.3d 418, 423 (3d Cir. 2006); see also Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). Disputes over
irrelevant or unnecessary facts will not preclude a grant of
summary judgment. Anderson, 477 U.S. at 248. “In considering a
evidence; instead, the non-moving party’s evidence ‘is to be
believed and all justifiable inferences are to be drawn in his
favor.’” Marino v. Indus. Crating Co., 358 F.3d 241, 247 (3d Cir.
2004) (quoting Anderson, 477 U.S. at 255); see also Matsushita
Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, (1986);
Curley v. Klem, 298 F.3d 271, 276-77 (3d Cir. 2002).
The party moving for summary judgment has the initial burden
of showing the basis for its motion. Celotex Corp. v. Catrett, 477
U.S. 317, 323 (1986). “If the moving party will bear the burden of
persuasion at trial, that party must support its motion with
credible evidence . . . that would entitle it to a directed verdict
if not controverted at trial.” Id. at 331. On the other hand, if
the burden of persuasion at trial would be on the nonmoving party,
the party moving for summary judgment may satisfy Rule 56’s burden
of production by either (1) “submit[ting] affirmative evidence
that negates an essential element of the nonmoving party’s claim”
or (2) demonstrating “that the nonmoving party’s evidence is
insufficient to establish an essential element of the nonmoving
party’s claim.” Id. Once the movant adequately supports its motion
pursuant to Rule 56(c), the burden shifts to the nonmoving party
to “go beyond the pleadings and by her own affidavits, or by the
depositions, answers to interrogatories, and admissions on file,
designate specific facts showing that there is a genuine issue for
trial.” Id. at 324; see also Matsushita, 475 U.S. at 586; Ridgewood
Bd. of Ed. v. Stokley, 172 F.3d 238, 252 (3d Cir. 1999). 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 factfinder. Big Apple BMW, Inc. v. BMW of N.
Am., Inc., 974 F.2d 1358, 1363 (3d Cir. 1992).
There can be “no genuine issue as to any material fact,”
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, 477 U.S. at 322-23. “[A] complete failure of proof
concerning an essential element of the nonmoving party’s case
necessarily renders all other facts immaterial.” Id. at 323; Katz
v. Aetna Cas. & Sur. Co., 972 F.2d 53, 55 (3d Cir. 1992).
Failure to Warn
With respect to Plaintiff’s failure to warn claim, 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.
Indeed, the sole basis for Defendants’
summary judgment motion on Plaintiff’s failure to warn claim is
the defense under the learned intermediary doctrine; Defendants do
not challenge, on this motion, Plaintiff’s position that Plavix’s
label is inadequate.
In order to establish a prima facie case for failure to warn
under New York law, a plaintiff must show the following: (1) the
manufacturer had a duty to warn; (2) the manufacturer breached the
duty to warn in a manner that rendered the product defective, i.e.,
proximate cause of the plaintiff's injury; and (4) the plaintiff
suffered loss or damage. See McCarthy v. Olin Corp., 119 F.3d 148,
156 (2d Cir. 1997) (citing Becker v. Schwartz, 46 N.Y.2d 401, 410
(1978)); see also In re Fosamax Prods. Liab. Litig., 924 F. Supp.
2d 477, 486 (S.D.N.Y. 2013); Mustafa v. Halkin Tool, Ltd., No. 004851, 2007 U.S. Dist. LEXIS 23096, at *17 (E.D.N.Y. Mar. 29, 2007).
Importantly, these elements of a failure to warn claim remain
the same under New York law regardless of whether they sound in
negligence or strict liability. See Martin v. Hacker, 83 N.Y.2d 1,
8 n.1, (1993); Fane v. Zimmer, Inc., 927 F.2d 124, 130 (2d Cir.
denominate the cause of action . . . where the theory of liability
equivalent.’” (quoting Wolfgruber v. Upjohn Co., 423 N.Y.S.2d 95,
97 (N.Y. App. Div. 1979))).
Generally, a manufacturer has a duty to warn (1) “against
latent dangers resulting from foreseeable uses of its product of
which it knew or should have known,” and (2) “of the danger of
unintended uses of a product provided these uses are reasonably
foreseeable.” Liriano v. Hobart Corp., 92 N.Y.2d 232, 237 (1998);
see also State Farm Fire & Cas. Co. v. Nutone, Inc., 426 Fed. App'x
8, 10 (2d Cir. 2011); Glucksman v. Halsey Drug Co., 553 N.Y.S.2d
724, 726 (App. Div. 1990). “This duty is a continuous one, and
requires that the manufacturer be aware of the current information
concerning the safety of its product.” Krasnopolsky v. WarnerLambert Co., 799 F. Supp. 1342, 1345-46 (E.D.N.Y. 1992). “Liability
for failure to warn may be imposed based upon either the complete
failure to warn of a particular hazard or the inclusion of warnings
that are insufficient.” Fisher v. Multiquip, Inc., 949 N.Y.S.2d
214, 218 (App. Div. 2012) (citation and internal quotation marks
Typically, summary judgment is appropriate where a plaintiff
has failed to introduce any evidence that a manufacturer knew or
should have known of the danger at issue. See Colon ex rel. Molina
v. BIC USA, Inc., 199 F. Supp. 2d 53, 93-94 (S.D.N.Y. 2001); see
also Wolfgruber, 423 N.Y.S.2d at 97-98 (granting defendant summary
judgment in failure to warn case when there were no disputed
facts). On the other hand, “the adequacy of a warning generally is
a question of fact,” best reserved for trial. Kandt v. Taser Int'l,
Inc., No. 09-0507, 2012 U.S. Dist. LEXIS 96024, at *3 (N.D.N.Y.
July 10, 2012)(quoting Fisher, 949 N.Y.S.2d at 218); see also Urena
v. Biro Mfg. Co., 114 F.3d 359, 366 (2d Cir. 1997) (“‘The adequacy
of the instruction or warning is generally a question of fact to
be determined at trial and is not ordinarily susceptible to the
drastic remedy of summary judgment.’” (quoting Beyrle v. Finneron,
606 N.Y.S.2d 465, 465 (App. Div. 1993))).
When evaluating failure to warn liability, a court must
conduct an “intensely fact-specific” analysis, “including but not
limited to such issues as feasibility and difficulty of issuing
warnings in the circumstances; obviousness of the risk from actual
use of the product; knowledge of the particular product user; and
proximate cause.” Anderson v. Hedstrom Corp., 76 F. Supp. 2d 422,
440 (S.D.N.Y. 1999) (quoting Liriano, 92 N.Y.2d at 243) (internal
quotation marks omitted).
Where a manufacturer owes a duty to
warn, it can satisfy this obligation by “warn[ing] of all potential
dangers in its prescription drugs that it knew, or, in the exercise
of reasonable care, should have known to exist.” Davids v. Novartis
Pharms. Corp., 857 F. Supp. 2d 267, 286 (E.D.N.Y. 2012) (quoting
Sita v. Danek Med., Inc., 43 F. Supp. 2d 245 (E.D.N.Y. 1999))
(alternation in original and internal quotation marks omitted).
patient's doctor (and not to the patient himself) pursuant to the
“learned intermediary” rule. See Bravman v. Baxter Healthcare
Corp., 984 F.2d 71, 75 (2d Cir. 1993); Lindsay v. Ortho Pharm.
manufacturer’s duty is to warn the doctor, not the patient). The
logic underlying this rule is that “[t]he doctor acts as an
‘informed intermediary’ between the manufacturer and the patient,
evaluating the patient's needs, assessing the risks and benefits
of available drugs, and prescribing and supervising their use.”
Davids, 857 F. Supp. 2d at 286 (quoting Glucksman, 553 N.Y.S.2d at
726) (internal quotation marks omitted).
Thus, if a defendant
fails to adequately warn a patient's physician of the dangers
presented by a given pharmaceutical, and the patient suffers an
injury on account of such failure to warn, a failure to warn claim
In sum, the “learned intermediary doctrine,” provides
that (1) that manufacturers of prescription drugs and medical
devices discharge their duty to of care to patients by providing
adequate warnings to prescribing physicians, and (2) that any
failure to warn cannot be considered a proximate cause of a
subsequent injury if the physician was fully aware of the dangers
that would have been included in an alternative warning.” Shepherd
v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), No. 041596, 2011 U.S. Dist. LEXIS 66664, at *4 (E.D.N.Y. June 23, 2011).
Indeed, nationally, it is well-settled that in prescription
drug failure-to-warn cases, courts apply this doctrine. See, e.g.,
Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 816 (11th Cir.
2010) (concluding that summary judgment was proper where the
“doctor provided explicit, uncontroverted testimony that, even
when provided with the most current research and FDA mandated
warnings, he still would have prescribed [the drug] . . . .
assertion severs any potential chain of causation”); Motus v.
Pfizer Inc., 358 F.3d 659, 661 (9th Cir. 2004) (holding that “a
product defect claim based on insufficient warnings cannot survive
summary judgment if stronger warnings would not have altered the
conduct of the prescribing physician”) (citing Plummer v. Lederle
Labs., 819 F.2d 349, 358-59 (2d Cir. 1987); Ebel v. Eli Lilly &
Co., 536 F.Supp. 2d 767 (S.D. Tex. 2008) (granting summary judgment
for defendant upon finding that prescribing physician was aware of
Zyprexa's suicide-related risks that an adequate warning would
physician would not have prescribed Zyprexa had defendant provided
him with an alternate warning label), aff'd, 321 Fed. App'x 350
(5th Cir. 2009) (per curiam); Allgood v. GlaxoSmithKline PLC, No.
06-3506, 2008 U.S. Dist. LEXIS 12500, at *3 (E.D. La. Feb. 20,
2008) (granting summary judgment to defendant because plaintiff
had failed to show (1) that defendant did not adequately warn the
physician of a risk associated with the drug that was not otherwise
known to the physician and (2) that the "failure to warn the
physician was both a cause in fact and the proximate cause of the
plaintiffs injury"), aff'd sub nom. Allgood v. SmithKline Beecham
Corp., 314 Fed. App'x 701 (5th Cir. 2009) (per curiam).
Here, I note that Plaintiff’s opposition begins by submitting
the expert testimony of Dr. Peter Rheinstein, who essentially
opines on various inadequacies of Plavix’s label at the time
Plaintiff was taking Plavix.
Specifically, Dr. Rheinstein found
that Plavix’s warnings failed to warn physicians about the lack of
published studies evaluating the use of Plavix for longer than one
year following implantation of a drug eluting stent.
Rheinstein’s report, Plaintiff argues that summary judgment is not
appropriate since the sufficiency of a warning label is a factual
determination to be made by a jury.
While Plaintiff is correct
that New York courts have so held, see Ramirez v. Wyeth Labs.,
Inc., 686 N.Y.S.2d 602, 607 (Sup. Ct. 1999), the question that has
been raised by Defendants, here, is not whether Plavix’s warning
was adequate, but rather, under the learned intermediary doctrine,
whether Plaintiff’s treating physician — Dr. Richter — would have
prescribed Plavix even when provided with the most current research
and FDA mandated warnings.
This is the relevant inquiry on this
Thus, Dr. Rheinstein’s report regarding the alleged
insufficiencies of Plavix’s warnings does not appear to be a
relevant consideration on Defendants’ defense pursuant to the
learned intermediary doctrine.
However, during oral argument,
Rheinstein’s report calls into question Dr. Richter’s credibility
as the learned intermediary. I will address that contention, next.
But, before I discuss Plaintiff’s arguments on why summary
judgment should be denied despite Dr. Richter’s testimony, I note
Plaintiff's burden to prove that a different warning would have
changed the physician's decision to prescribe the medication.
Head v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), 649
F. Supp. 2d 18, 32 (E.D.N.Y. 2009); Alston v. Caraco Pharm, Inc.,
demonstrate that had a different, more accurate warning been
given, his physician would not have prescribed the drug in the
same manner.”); Golod v. Hoffman La Roche, 964 F.Supp. 841, 856
(S.D.N.Y. 1997) (“the plaintiff must generally demonstrate that
had appropriate warnings been given, the treating physician would
not have prescribed or would have discontinued use of the drug.”);
Mulhall v. Hannafin, N.Y.S.2d 282, 287 (App. Div. 2007) (reversing
a denial of summary judgment for defendant where the plaintiff had
different course of treatment had the warnings been different).
Stated differently, Plaintiff bears the burden of raising a genuine
issue of material fact as to Dr. Richter’s testimony, and if
Plaintiff fails to do so, summary judgment may be appropriate.
(granting summary judgment in favor of defendant wherein plaintiff
failed to create an issue of credibility with the prescribing
Here, it is clear from the above-referenced testimony of Dr.
Richter that he was aware of the serious risks of bleeding when
placing Plaintiff on a dual therapy regime of Plavix and aspirin.
Indeed, his opinion was unequivocal: because the medical benefits
for Plaintiff's condition outweighed the risks, the physician was
confident that the treatment he had provided for Plaintiff was
medically necessary and appropriate.
And, more compellingly, Dr.
Richter testified that having reviewed all the relevant studies
regarding Plavix, he believes — even now — that prescribing Plavix
to Mr. Hopkins was the most appropriate medical therapy.
In response, Plaintiff has produced no evidence - testimonial
or otherwise - to suggest that a different warning would have led
his doctor to alter the treatment for Plaintiff. More importantly,
Rather than meeting his burden, Plaintiff, first, argues that
Dr. Richter’s uncontradicted testimony is not a sufficient basis
to grant summary judgment on causation, because it is the province
of the jury to determine that question.
Plaintiff reasons that so
long as Dr. Richter’s testimony is not “self-disserving,” his
statements must be presented to the factfinder.
all the relevant authorities, I reject Plaintiff’s position.
Mainly, for his proposition, Plaintiff relies on Golod, a
decision from the Southern District of New York.
In that case,
defendant drug manufacturer filed a motion for summary judgment,
warning, even if inadequate, caused plaintiff’s injuries because
the treating physician testified that he would have nonetheless
prescribed the drug with stronger warnings.
Golod, 964 F.Supp. at
Admittedly, the court rejected that argument explaining that
because the physician was not a defendant in the action, it was
prescribed the drug with different warnings.
In so finding,
That same line of reasoning was used by the Second Circuit in
a relatively older decision of Bravman v. Baxter Healthcare Corp.,
984 F.2d 71 (2d Cir. 1993).
In Bravman, the court found that
plaintiff’s treating physician,] testified that he would not have”
made a different decision regarding treatment even if he knew about
the noise issues with an implanted heart valve, “that testimony is
insufficient to resolve the proximate cause question.”
Id. at 75.
In that court’s view, “[i]t is up to the trier of fact to determine
whether, and the extent to which, Dr. Spencer’s testimony on this
point is credible.”
Although Dr. Spencer was not a defendant
in that case, the Second Circuit, nonetheless, found that “unless
credibility of the physician’s affidavit should ordinarily be
left” to the jury.
I do not find Golod or Bravman convincing;
The Golod Court also found the doctor’s testimony to be
equivocal on the issue of whether if he was given a stronger
warning, he would have nevertheless continued the plaintiff on the
same drug. Id. at 857.
in my view, those decisions misstated the law mistakenly extended
the reach or prior case law.
The term “self-disserving” was derived from an earlier New
Pharmaceutical Corp., 516 N.Y.S. 2d 856 (Sup. Ct. 1987).
Hoffman-Rattet, the prescribing doctor had been a defendant in the
suit, but the claims against her were dismissed on statute of
Defendant pharmaceutical company sought to
use the doctor’s testimony that she would not have altered her
treatment for the plaintiff.
Because the doctor had been a
defendant, the court held that the doctor’s credibility was in
First, the court explained that if a prescribing doctor is
a defendant in suit, his or her testimony must be “self-disserving”
— statements that are against the doctor’s self-interests — before
that testimony could be a sufficient basis upon which to grant
In that regard, the court found that because
the doctor in that case was “an actor in the transaction in
question, [she] is an interested witness, [and] her testimony is
subject to attack on credibility. 6
The takeaway from Hoffman-Rattet is that when a treating
physician is a defendant in a case brought by the plaintiff, that
physician’s testimony, in the context of the learned intermediary
Indeed, the court found other reasons to
doctor’s testimony, which are not relevant here.
doctrine, must be self-disserving — or against the physician’s
self-interest — before the testimony can be a sufficient basis to
grant summary judgment. Indeed, I agree with that conclusion, since
a physician-defendant’s credibility is in doubt when he or she is
also defending claims brought by the same plaintiff.
the treating doctor is not a defendant, but rather a disinterested
witness, the same concern regarding credibility is not present.
Instead, those courts relied on Hoffman-Rattet and
extended the concept of “self-disserving” to testimony from a
physician who was not a defendant, without explaining why the
credibility of a disinterested witness should be questioned simply
because the doctor treated the plaintiff.
Importantly, if I were
to follow Bravman, summary judgment would never be granted in these
types of cases, because a third-party prescriber’s testimony would
always be subject to doubt, unless the prescriber testified he or
she would not have prescribed the drug.
Such a one-sided result
for a disinterested physician’s testimony cannot be correct.
Because I am applying New York state law, the Second Circuit’s
decision in Bravman is not binding on this Court.
See Aceto v.
Zurich Ins. Co., 440 F.2d 1320, 1322 (3d Cir. 1971).
look to other New York state court decisions to inform me.
I have not found any decision on this issue by the New York Court
of Appeals, there is, however, an appellate decision that I find
See Sheridan v. NGK Metals Corp., 609 F.3d 239, 254
(3d Cir. 2010) (“Where an intermediate appellate state court rests
its considered judgment upon the rule of law which it announces,
that is a datum for ascertaining state law which is not to be
disregarded by a federal court . . . .”).
In Sacher v. Long Island
Jewish-Hillaide Medical Center, 142 A.D.2d 567 (N.Y. App. Div.
1988), the defendant-pharmaceutical company, on summary judgment,
physician, who was also named as a defendant in suit, that he was
differently even if adequate warnings were given. The court denied
summary judgment, explaining that “self-serving statements of an
interested party which refers to matters exclusively within that
party’s knowledge create an issue of credibility which should not
be decided by the court but should be left for the trier of facts.”
Id. (emphasis added).
Because the physician in Sacher was an
interested party, the court found his testimony not sufficient for
summary judgment purposes.
As I read Sacher and Hoffman-Rattet, opinions by state courts
interpreting state law, I conclude that so long as a prescribing
physician is a defendant in a case brought by a plaintiff, the
credibility of that physician’s testimony must be decided by a
jury. However, if a treating doctor is not a defendant, but merely
a third-party witness, his or her testimony, without any evidence
of credibility issues, is a sufficient basis to grant summary
I note that no New York state court has endorsed
Bravman’s holding that a prescribing doctor’s testimony is not
sufficient to warrant summary judgment.
Rather, just the opposite
is true; New York’s highest court has found summary judgment
appropriate where the motion is based on unrebutted deposition
See Alvarez v. Prospect Hosp., 68 N.Y.2d 320, 324-26
Gonzalez v. 98 Mag Leasing Corp., 95 N.Y.2d 124, 129 (2000); Nomura
Asset Capital Corp. v. Cadwalader, Wickersham & Taft LLP, 26 N.Y.3d
40, 50-52 (2015).
Moreover, a district court from the Eastern District of New
York, confronted with a similar question, has explained the scope
of the effect of a prescriber’s testimony by concluding that “[i]n
physician’s statement that he would have followed the same course
physician has been a defendant and the statements found to be selfserving.”
Krasnopolsky, 799 F.Supp. at 1347.
Krasnopolsky was not a defendant, the court relied on the doctor’s
testimony to grant summary judgment in favor of the defendant-drug
Here, because Dr. Richter is not a defendant in this suit,
and Plaintiff has not brought claims against his doctor in other
forums, Dr. Richter’s testimony does not, on its face, raise any
credibility issues. 7
However, as a last ditch effort, Plaintiff’s
counsel inexplicably contended, during oral argument, that Dr.
Rheinstein’s Declaration somehow impacts the credibility of Dr.
According to Dr. Rheinstein, because Defendants failed
to warn consumers that BMS did not conduct any studies regarding
the safety and efficacy of Plavix for a prolonged period of time,
Plavix warning labels were insufficient.
In that regard, it is
Plaintiff’s position that Dr. Richter’s testimony is simply not
Generally speaking, courts routinely rely on unrebutted
testimony, particularly from experts, to grant summary judgment.
See, e.g., Kelly-Brown v. Winfrey, 659 Fed. Appx. 55 (2d Cir.
2016)(affirming grant of summary judgment based in part on
unrebutted expert testimony); Diaz v. Johnson Matthey, Inc., 893
F. Supp. 358, 361 (D.N.J. 1995) (finding that where plaintiff had
no expert on exposure to toxin to counter defense experts, he could
not "prove causation, and summary judgment . . . must be
granted."); Luby v. Carnival Cruise Lines, Inc., 633 F. Supp. 40,
42 n.3 (S.D. Fla. 1986) (noting that, "[w]here, as here, an issue
is one of the kind on which expert testimony must be presented,
and the affidavit of the expert is uncontradicted, summary judgment
is proper"); Brown v. Kordis, 46 Fed. Appx. 315, 317 (6th Cir.
2002) (holding that "the district court did not err in granting
summary judgment" since the "unrebutted expert testimony" left no
genuine issue of material fact); Evans v. Mentor Corp., No. 1:04CV-1218, 2005 U.S. Dist. LEXIS 37069, at *7 (E.D. Va. Jun. 28,
2005) (finding that the Defendant was entitled to summary judgment
because "Plaintiff's speculative evidence [was] countered by
[Defendant's] unrebutted expert testimony"); Sierra Club v. Ga.
Power Co., No. 3:02-CV-151, 2007 U.S. Dist. LEXIS 100219, at *25
(N.D. Ga. Jan. 11, 2007) (ruling that since the defendant
"presented powerful and uncontradicted expert testimony," the
defendant is entitled to summary judgment).
“credible” since the doctor had no studies — as to the prolonged
use of Plavix — to rely upon when he prescribed Plavix to Plaintiff
for over eight years.
I find Plaintiff’s argument wholly without
First and foremost, it was conceded during oral argument that
Plaintiff’s counsel never questioned Dr. Richter at his deposition
on this issue.
See Motion Tr., T9:8-10. Indeed, to the extent
that counsel believed that Dr. Richter would have given different
testimony, or that Dr. Richter would have found it important that
conducted regarding the prolonged use of the drug, counsel failed
to pose such questions during Dr. Richter’s deposition.
to the contrary, according to Dr. Richter, he read and relied upon
various studies regarding the efficacy and risks of Plavix.
Richter Dep., T21:11-T24:4. More to the point, each of the studies
reported the duration of that study which defined the limited time
treatment for an average of 1.6 years (maximum of 3 years)”, and
in the CURE study, patients “were randomized to receive PLAVIX .
. . and were treated for up to one year.”
Rooney Decl., Ex. B, §
Hence, having reviewed these studies, see
durations of the available studies, and by extension, the lack of
any studies with prolonged and extended use of Plavix.
stated that it was his medical opinion that Plaintiff should remain
on Plavix permanently, see id. at T45:12-16, and that even today,
“appropriate medical therapy.”
Id. at T51:16-20.
sufficient to preclude a drug manufacturer’s liability to an
McDowell v. Eli Lilly & Co., 58 F. Supp. 3d
391, 406 (S.D.N.Y. 2014) (quoting Banker, 278 A.D.2d at 722).
also Andre v. Mecta Corp., 587 N.Y.S.2d 334, 335 (App. Div. 1992)
(“existing knowledge of the relevant hazard by the [prescribing
doctor] may be so apparent, that liability may be resolved in favor
of the manufacturer as a matter of law”).
Here, Dr. Richter’s
uncontradicted testimony of his independent knowledge of the risks
associated with Plavix “sever[s] the causal [chain] between an
(quoting Glucksman, 553 N.Y.S.2d at 726) (internal quotations
“The rationale for this rule is that knowledge of the
Concepts, Inc., No. 05-774S, 2011 U.S. Dist. LEXIS 107286, at *2728 (W.D.N.Y. Sep. 22, 2011).
In fact, even if the drug’s warnings
were inadequate, the prescribing physician’s independent knowledge
of the risks is nonetheless an intervening event that precludes
the manufacturer’s liability.
Tomaselli v. Zimmer Inc., No. 14-
04474, 2017 U.S. Dist. LEXIS 9874, at *13 (S.D.N.Y. Jan. 20, 2017);
Steinman, 2011 U.S. Dist. LEXIS 107286, at *28.
Based on these reasons, I conclude that Plaintiff has failed
to present any conflicting evidence to create doubt regarding the
credibility of Dr. Richter, and therefore, it is clear that the
learned intermediary doctrine applies here. 8
The Court is no stranger to the issues raised on this motion.
Indeed, I have granted summary judgment based on the learned
intermediary doctrine in previous failure to warn cases which also
concerned Plavix, brought by various out-of-state plaintiffs.
See, e.g., Begley v. Bristol-Myers Squibb Co., No. 06-6051, 2013
U.S. Dist. LEXIS 4849 (D.N.J. Jan. 11, 2013); Carr-Davis v.
Bristol-Myers Squibb Co., No. 07-1098, 2013 U.S. Dist. LEXIS 10914
(D.N.J. Jan. 28, 2013); Cooper v. Bristol-Myers Squibb Co., No.
07-885, 2013 U.S. Dist. LEXIS 1768 (D.N.J. Jan. 4, 2013); LaBarre
v. Bristol-Myers Squibb Co., No. 06-6050, 2013 U.S. Dist. LEXIS
10082 (D.N.J. Jan. 11, 2013); Mattson v. Bristol-Myers Squibb Co.,
No. 07-908, 2013 U.S. Dist. LEXIS 58563 (D.N.J. Apr. 22, 2013),
Solomon v. Bristol-Myers Squibb Co., 916 F. Supp. 2d 556 (D.N.J.
2013). The Third Circuit affirmed my decisions in that regard.
See LaBarre v. Bristol-Myers Squibb Co., 544 Fed. App'x 120 (3d
In fact, the circuit court has routinely affirmed causationbased summary judgment pursuant to a treating physician’s
See, e.g., In re Avandia Mktg., Sales Practices, &
Prods. Liab. Litig., 639 Fed. App’x 874, 876 (3d Cir. 2016)
(affirming summary judgment under Pennsylvania law where the
prescriber testified that he would have prescribed the same
medication to a patient presented with the same medical
conditions); Bock v. Novartis Pharm. Corp., 661 Fed. App’x 227,
232 (3d Cir. 2016) (affirming the district court’s grant of summary
judgment on a failure to warn claim, relying on prescribing
physicians’ testimony that they “would still prescribe the drug
today if presented with a patient such as [plaintiff], because, in
their medical judgment, the benefits of the drug significantly
outweigh the risks”); Grobelny v. Baxter Healthcare Corp., 341
Plaintiff’s failure to warn claim, in favor of Defendants.
III. Design Defect
Plaintiff alleges that Defendants are liable under a theory
of design defect for injuries that resulted from taking Plavix.
Defendants advance three theories why summary judgment should be
granted in their favor.
First, Defendants argue that comment k to
§ 402(A) of the Restatement (Second) of Torts bars design defect
“unavoidably unsafe”, are “properly prepared, and accompanied by
proper directions and warning.”
402A cmt. K (1965).
Restatement (Second) of Torts §
Second, Defendants contend that the design
defect claim fails because Plaintiff has not established that an
alternative design is available for Plavix.
claim that Plaintiff’s design defect claim is preempted by federal
law because any change to Plavix would require further approval
and review by the FDA.
In response, Plaintiff argues that comment k does not operate
to bar design defect claims here.
Second, Plaintiff claims that
there is no requirement that he must prove an alternative design
Fed. App’x 803, 808 (3d Cir. 2009) (affirming the district court’s
grant of summary judgment on a failure to warn claim based on the
prescribing physician’s testimony at deposition that he was aware
of the risks of the drug and prescribed the drug to plaintiff
notwithstanding these risks).
is available, but rather, proving an alternative design is only
one factor in a balancing test established by the New York Court
See Voss v. Black & Decker Mfg. Co., 59 N.Y.2d 102,
Finally, Plaintiff contends that his design defect
claim is not preempted by federal law because Defendants have not
provided any evidence on their motion that it was impossible for
I turn to these issues.
Comment k of § 402(A)
Comment k to § 402(A) of the Restatement (Second) of Torts
prescription drug, is accompanied by proper warnings, that product
is not defective.
Restatement (Second) of Torts § 402A cmt. K
Use of comment k to bar a design defect claim then is
Martin, 83 N.Y.2d at 8.
While Defendants invoke comment k as a defense to Plaintiff’s
design defect claim, this defense is unavailable to them because
the question of whether Plavix’s warning was adequate has not been
raised by Defendants on their motion for summary judgment. Rather,
Defendants’ basis for summary judgment on Plaintiff’s failure to
warn claim is on the prescribing physician’s testimony pursuant to
the learned intermediary doctrine. Id. at 8 (“The comment k defense
Indeed, whether Plavix’s warning was adequate is not
at issue on this motion.
Accordingly, the comment k defense is
not appropriate to bar Plaintiff’s design defect claim on this
The Balancing Test
inadequacy of Plavix’s warning.
Typically, however, design defect
claims are based upon the structure and planned design of a
Voss, 59 N.Y.2d at 109 (quoting Robinson v.
Reed-Prentice Div. of Package Mach. Co., 49 N.Y.2d 471, 479 (1980))
(“a defectively designed product is one which, at the time it
dangerous for its intended use”).
Indeed, under New York law, a
plaintiff typically brings a defective design claim against a drug
company alleging that a particular drug is inherently unsafe due
to its composition.
See, e.g., Yates v. Ortho-McNeil-Janssen
Pharms, Inc., 808 F.3d 281, 296 (6th Cir. 2015) (where plaintiff
claimed that there was too high of a level of the active ingredient
in a pharmaceutical). Under comment k, if that drug is accompanied
by a proper and adequate warning, plaintiff’s defective design
claim would necessary fail.
Conversely, if the warning label of
the drug is insufficient, the plaintiff then proceeds to prove
that the design, i.e., composition of the pharmaceutical, is
But, here, Plaintiff’s claim is solely based on inadequate
warning, not that Plavix is inherently unsafe.
I have not found
permitted a claim of design defect to proceed based on a theory of
See Wholey v. Amgen, No. 162934/2015, N.Y.
Misc. LEXIS 852, at *1, *20 (N.Y. Sup. Ct. Mar. 8, 2017) (finding
a design defect claim based on a theory of failure to warn to be
duplicative of the Plaintiffs’ failure to warn claims and choosing
to only analyze them under a failure to warn standard rather than
under the design defect standard). 9
Indeed, under New York law, in assessing a products liability
claim based on design defect, such as a prescription drug, courts
use two multifactor balancing tests.
See Wholey, N.Y. Misc. LEXIS
Indeed, in New York, a cause of action in strict products
liability lies where a manufacturer places on the market a product
which has a defect that causes injury. Robinson, 49 N.Y.2d at 471
(citing Codling v Paglia, 32 N.Y.2d 330, 342 (1973)). A defect in
a product may consist of one of three circumstances: (1) mistake
in manufacturing, see Victorson v Bock Laundry Mach. Co., 37 N.Y.2d
395 (1975); (2) improper design, see Micallef v Miehle Co., Div.
of Miehle-Goss Dexter, 39 N.Y.2d 376 (1975); Bolm v Triumph Corp.,
33 N.Y.2d 151(1973); or (3) by the inadequacy or absence of
warnings for the use of the product, Torrogrossa v Towmotor Co.,
44 N.Y.2d 709 (1978). Clearly, improper warning is a separate and
distinct cause of action from improper design or design defect.
See Liriano, 92 N.Y.2d at 232.
852, at *11.
The first balancing test involves a seven-factor
evaluation of the risk and utility of the product to society.
Denny v. Ford Motor Co., 87 N.Y.2d 248, 257 (1995); Voss, 59 N.Y.2d
at 109; Wholey, N.Y. Misc. LEXIS 852, at *11-12.
The seven factors
(1) The utility of the product to the public as a whole
and to the individual user; (2) the nature of the product
-- that is, the likelihood that it will cause injury;
(3) the availability of a safer design; (4) the potential
for designing and manufacturing the product so that it
is safer but remains functional and reasonably priced;
(5) the ability of the plaintiff to have avoided injury
by careful use of the product; (6) the degree of
awareness of the potential danger of the product which
reasonably can be attributed to the plaintiff; and (7)
the manufacturer’s ability to spread any cost related to
improving the safety of the design.
Voss, 59 N.Y.2d at 109.
Then, courts must consider whether the
product was a proximate cause or “substantial factor” of the
plaintiff’s injury and use a three-factor test for that analysis.
Voss, 59 N.Y.2d at 106 (quoting Codling, 32 N.Y.2d at 342).
factors for the proximate cause three-factor test include:
(1) That at the time of the occurrence the product is
being used for the purpose and in the manner normally
intended, (2) that if the person injured or damaged is
himself the user of the product he would not by the
exercise of reasonable care have both discovered the
defect and perceived its danger, and (3) that by the
exercise of reasonable care the person injured or
damaged would not otherwise have averted his injury or
None of factors relate to an assessment of warnings on a
Instead, the multi-factored tests concern the safety of
a particular product for its typical usage.
Accordingly, I do not
find that, under New York law, Plaintiff can bring a design defect
claim based on inadequate warning, alone.
Regardless, even if Plaintiff could bring a design defect
claim under a theory of inadequate warning, Plaintiff fails to
Plaintiff is correct that such an alternative is not required to
prove a strict liability claim of design defect, it is an important
factor in the Court’s balancing test.
See, e.g., Gaudette v. St.-
(N.D.N.Y. Mar. 28, 2014) (“[t]he showing of a feasible, alternative
design is a sine qua non of a design defect claim”) (citation
Furthermore, under the balancing test, Plaintiff must
show that the product could have been designed more safely even if
an alternative design was not offered.
Urena, 114 F.3d at 365;
Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395, 405 (S.D.N.Y.
Plaintiff has done neither.
Furthermore, while Plaintiff
has advocated for a more specific label for Plavix, and while it
would arguably be feasible for the manufacturer to include a
different label on Plavix, that is the only factor that Plaintiff
has addressed on this motion through the expert report of Dr.
burden of proving that the design defect balancing factors weigh
in his favor. See Urena, 114 F.3d at 365 (finding that Plaintiff
bears the burden of proving that each of the factors weigh in his
favor); Fane, 927 F.2d at 129; Voss, 59 N.Y.2d at 107.
Defendants are entitled to summary judgment on the design defect
See Mathis-Kay v. McNeilus Truck & Mfg., No. 06-CV-815S,
2011 U.S. Dist. LEXIS 109677, at *16 (“[i]f, after considering
these factors, a reviewing court determines that the plaintiff has
failed to establish a prima facie case of design defect, the court
may dismiss the claim as a matter of law.”); Scarangella v. Thomas
Built Buses, Inc., 695 N.Y.S.2d 520, 523 (1999); Tomaselli, 2017
U.S. Dist. LEXIS 9874, at *18 (dismissing plaintiffs’ design defect
claims on summary judgment because they “have failed to meet their
burden . . . .”).
Because Plaintiff’s design defect claims fail on this basis,
I need not address Defendants’ assertion of federal preemption.
Loss of Consortium
Because all the underlying substantive claims fail, summary
judgment is appropriate as to the loss of consortium claim, as
well. See Liff v. Schildkrout, 49 N.Y.2d 622, 632 (1980); Kornicki
v. Shur, 17 N.Y.S.3d 396, 397 (App. Div. 2015).
summary judgment is GRANTED.
Plaintiff’s Complaint is, therefore,
August 17, 2017
/s/ Freda L. Wolfson
Freda L. Wolfson
United States District Judge
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