NOT PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
_____________
No. 13-1405
_____________
ELOISE LABARRE,
as surviving spouse & administratix of
the Est. of Edward LaBarre, Sr.,
Appellant
v.
BRISTOL-MYERS SQUIBB COMPANY; SANOFI-AVENTIS U.S. LLC;
SANOFI-AVENTIS U.S., INC.; SANOFI-SYNTHELABO, INC.
_____________
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
(D.C. No. 3-06-cv-06050)
District Judge: Honorable Freda L. Wolfson
_____________
No. 13-1406
_____________
PATRICIA BEGLEY,
Appellant
v.
BRISTOL-MYERS SQUIBB COMPANY; SANOFI-AVENTIS U.S. LLC;
SANOFI-AVENTIS U.S., INC.; SANOFI-SYNTHELABO, INC.
_____________
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
(D.C. No. 3-06-cv-06051)
District Judge: Honorable Freda L. Wolfson
______________
Submitted Under Third Circuit LAR 34.1(a)
November 15, 2013
______________
Before: HARDIMAN, SHWARTZ, and SCIRICA Circuit Judges.
(Filed: November 18, 2013)
______________
OPINION
______________
SHWARTZ, Circuit Judge.
Eloise LaBarre, as surviving spouse and adminstratrix of the estate of Edward
LaBarre, Sr., and Patricia Begley bring two products liability cases concerning the
prescription drug Plavix, a blood thinner manufactured and sold by Bristol-Myers Squibb
Company, Sanofi-Aventis U.S. LLC, Sanofi-Aventis U.S., Inc., and Sanofi-Synthelabo,
Inc. (together, the “Defendants”). In both cases, the District Court entered an order
granting summary judgment in favor of the Defendants. We will affirm both orders.
I. Background
A. Plavix
Plavix is used to treat individuals at risk for heart attack, stroke, and circulation
problems. Because Plavix inhibits the formation of blood clots, it increases the risk of
bleeding. The labeling disclosed this risk. 1
1
The label provided:
PRECAUTIONS
2
The FDA has approved the use of Plavix with aspirin to treat individuals suffering
from acute coronary syndrome (“ACS”). Since aspirin also inhibits the formation of
blood clots, using the two drugs together increases the risk of bleeding, and the Plavix
label described this risk. 2
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. . . . PLAVIX should be
used with caution in patients who have lesions with a propensity to bleed
(such as ulcers).
...
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 [one study] 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.
App. 224-26.
2
The label provided:
ADVERSE REACTIONS
...
In [one study], PLAVIX use with aspirin was associated with an increase in
bleeding compared to [a] placebo with aspirin . . . . There was an excess in
major bleeding in patients receiving PLAVIX plus aspirin compared with
placebo plus aspirin, primarily gastrointestinal and at puncture sites.
3
B. Mr. LaBarre’s Medical History
Mr. LaBarre suffered from ACS. In October 2002, after a heart attack and other
complications resulting from ACS, Mr. LaBarre’s physicians prescribed Plavix. Shortly
thereafter, in preparation for a double bypass operation, Mr. LaBarre’s physicians
instructed him to stop taking Plavix. In July 2003, after suffering a second heart attack,
Mr. LaBarre’s physicians prescribed Plavix and aspirin. Mr. LaBarre remained on Plavix
and aspirin until December 2004. In December 2004, Mr. LaBarre hit his head. Two
weeks later, he developed a severe headache and became unconscious. Doctors
determined that Mr. LaBarre suffered a brain hemorrhage typically associated with
trauma. Mr. LaBarre died on December 21, 2004 as a result of the brain hemorrhage.
The death certificate indicated that the hemorrhage was a consequence of his Plavix
therapy.
C. Ms. Begley’s Medical History
Ms. Begley also suffers from ACS. In December 2003, Ms. Begley had a heart
attack, was found to have blocked coronary arteries, and had stents implanted. To
prevent blood clotting in the stents, Ms. Begley was prescribed Plavix and aspirin. With
only brief interruptions, Ms. Begley took Plavix with aspirin from December 2003
through January 2006. In December 2004, Ms. Begley suffered rectal bleeding and, in
January 2006, she suffered gastrointestinal bleeding.
D. Procedural History and the District Court Opinions
App. 226-27.
4
Ms. LaBarre and Ms. Begley (together, the “Plaintiffs”) filed products liability
suits against Defendants. Each asserted failure to warn, design defect, manufacturing
defect, and negligence claims. Ms. LaBarre’s claims were governed by Florida law, and
Ms. Begley’s claims were governed by Illinois law. Because the two cases involved the
same product and claims, the parties conducted joint discovery.
Before expert designations were due and before Plaintiffs deposed any of the
Defendants’ employees—but after Plaintiffs deposed the prescribing physicians—the
Defendants moved for summary judgment. 3 The District Court stayed discovery pending
its decision on the Defendants’ motion. Pursuant to Federal Rule of Civil Procedure
56(d), Plaintiffs filed an affidavit declaring that they sought “more information
concerning the inefficacy of Plavix.” The District Court denied Plaintiffs’ request for
additional discovery concerning Plavix’s efficacy since it found that Plavix’s efficacy
was irrelevant, under both Florida and Illinois law, to all of Plaintiffs’ claims.
The District Court the granted summary judgment in favor of the Defendants on
each claim. 4
3
Though expert reports were not yet due, Plaintiffs submitted the expert report of
Dr. Lemuel Moyé who provided opinions concerning Plavix’s efficacy and risks for
certain patients.
4
According to the District Court: (1) Plaintiffs’ failure to warn claims failed
because, among other things, Plaintiffs failed to present expert testimony on the
inadequacy of Plavix’s warning label as required by both Florida and Illinois law; (2)
under both Florida and Illinois law, comment k to § 402A of the Restatement (Second) of
Torts precluded Plaintiffs’ design defect claims; (3) as to the manufacturing defect
claims, Plaintiffs presented no evidence of a defect in the manufacturing process; and (4)
Plaintiffs’ negligence claims were simply a restatement of the other products liability
claims.
5
Plaintiffs now appeal. 5 Both argue that the District Court erred by denying their
request for additional discovery. Further, Ms. LaBarre asserts that the District Court
erred in granting summary judgment on her failure to warn and design defect claims.
II. Standard of Review
We review whether a district court prematurely granted summary judgment for
abuse of discretion. Hart v. Elec. Arts, Inc., 717 F.3d 141, 148 (3d Cir. 2013). “To
demonstrate an abuse of discretion, an appellant must show that the District Court’s
decision was arbitrary, fanciful or clearly unreasonable.” Id. (alterations and quotation
marks omitted).
We exercise plenary review over a District Court’s order granting summary
judgment. Jacobs Constructors, Inc. v. NPS Energy Servs., Inc., 264 F.3d 365, 369 (3d
Cir. 2001). Summary judgment is appropriate “if the movant shows that there is no
genuine dispute as to any material fact and the movant is entitled to judgment as a matter
of law.” Fed. R. Civ. P. 56(a). In reaching this decision, the Court must determine
“whether the pleadings, depositions, answers to interrogatories, admissions on file, and
affidavits show that there is no genuine issue of material fact and whether the moving
party is therefore entitled to judgment as a matter of law.” Macfarlan v. Ivy Hill SNF,
LLC, 675 F.3d 266, 271 (3d Cir. 2012) (citing Celotex Corp. v. Catrett, 477 U.S. 317,
322 (1986)). A disputed issue is “genuine” only if there is a sufficient evidentiary basis
on which a reasonable jury could find for the non-moving party. Kaucher v. Cnty. of
5
The District Court had jurisdiction pursuant to 28 U.S.C. § 1332. We have
jurisdiction pursuant to 28 U.S.C. § 1291.
6
Bucks, 455 F.3d 418, 423 (3d Cir. 2006) (citing Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 248 (1986)). A factual dispute is “material” only if it might affect the outcome
of the suit under governing law. Doe v. Luzerne Cnty., 660 F.3d 169, 175 (3d Cir. 2011)
(citing Gray v. York Newspapers, Inc., 957 F.2d 1070, 1078 (3d Cir. 1992)). Further,
“[w]e may affirm the District Court on any grounds supported by the record.” Nicini v.
Morra, 212 F.3d 798, 805 (3d Cir. 2000) (en banc).
III. Discussion
A. Discovery
A district court may grant summary judgment before discovery is completed so
long as the party opposing summary judgment has had “an adequate opportunity to obtain
discovery.” Dowling v. City of Phila., 855 F.2d 136, 138-39 (3d Cir. 1988); see also
Celotex Corp., 477 U.S. at 322. If a party opposing summary judgment “believes that
s/he needs additional time for discovery, Rule 56(d) specifies the procedure to be
followed.” Pa. Dep’t of Pub. Welfare v. Sebelius, 674 F.3d 139, 157 (3d Cir. 2012)
(quoting Dowling, 855 F.2d at 139, which addressed the predecessor to Rule 56(d), Rule
56(f)). Rule 56(d) provides:
If a nonmovant shows by affidavit or declaration that, for specified reasons,
it cannot present facts essential to justify its opposition, the court may: (1)
defer considering the motion or deny it; (2) allow time to obtain affidavits
or declarations or to take discovery; or (3) issue any other appropriate
order.
Fed. R. Civ. P. 56(d). The rule requires “a party seeking further discovery in response to
a summary judgment motion [to] submit an affidavit specifying, for example, what
particular information is sought; how, if uncovered, it would preclude summary
7
judgment; and why it has not previously been obtained.” Dowling, 855 F.2d at 139-40.
Except in rare cases, “failure to comply with [Rule 56(d)] is fatal to a claim of
insufficient discovery on appeal.” Bradley v. United States, 299 F.3d 197, 207 (3d Cir.
2002).
On appeal, Plaintiffs argue that the District Court abused its discretion by
proceeding with summary judgment on their failure to warn claim before the expert
reports were due and then granting summary judgment for failing to obtain such an expert
witness. Plaintiffs, however, submitted an affidavit seeking only additional information
from the Defendants about Plavix’s efficacy and did not state they sought additional time
to obtain expert testimony about the warnings. 6 Because Plaintiffs did not submit a Rule
56(d) affidavit requesting additional time to obtain such expert testimony, the District
Court had no reason to lift the discovery stay or withhold deciding the summary
judgment motion based on a potential need for expert testimony. Thus, “as a procedural
matter alone, [Plaintiffs] ha[ve] failed to comply with the rule,” Dowling, 855 F.2d at
140, and cannot rely on the purported lack of discovery as a basis to reverse the District
Court. Accordingly, the District Court “acted within the permissible bounds of its
discretion when it ruled on the [Defendants’] summary judgment motion on the record
before it.” Id. at 141.
6
Plaintiffs do not argue that the District Court abused its discretion by denying
their request for additional discovery concerning Plavix’s efficacy.
8
B. Ms. LaBarre’s Failure to Warn Claim
Under Florida law, 7 drug manufacturers have a duty to provide adequate warnings
of the drug’s dangerous side effects. Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683
(Fla. 1990). If a manufacturer fails to provide an adequate warning, it may be strictly
liable for any resulting harm. Buckner v. Allergan Pharms., Inc., 400 So. 2d 820, 822
(Fla. Dist. Ct. App. 1981). A manufacturer’s duty to warn runs to the physician
prescribing the drug rather than the patient taking the drug. 8 Felix v. Hoffmann-LaRoche,
Inc., 540 So. 2d 102, 104 (Fla. 1989). 9 To prevail on a failure to warn claim under
Florida law, a plaintiff must prove: “(1) that the warnings accompanying the item were
inadequate; (2) that the inadequacy of the warnings proximately caused [the plaintiff’s]
injury; and (3) that [the plaintiff] in fact suffered an injury by using the product.”
Colville v. Pharmacia & Upjohn Co., 565 F. Supp. 2d 1314, 1320 (N.D. Fla. 2008).
Ms. LaBarre advances two arguments on the adequacy of Plavix’s warnings.
First, she contends the warnings were inadequate because Mr. LaBarre’s physicians were
7
Our role in diversity cases is to apply state law as announced by the state’s
highest court. Sheridan v. NGK Metals Corp., 609 F.3d 239, 253 (3d Cir. 2010). If the
state’s highest court has not addressed an issue, we must predict the court’s position on
the issue. Id. In so doing, we may look to the decisions of intermediate appellate courts.
See id. at 254. Moreover, to promote “consistency of law and principles of comity,” we
may also look to lower state courts applying the decisions of intermediate state appellate
courts. Id.
8
Because Florida law applies, Ms. LaBarre’s argument that we should follow
State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E. 2d 899, 914 (W. Va. 2007), and
hold that a drug manufacturer’s duty to warn runs to the patient, is both contrary to
Florida law and inapplicable.
9
The Felix court explained that “the prescribing physician, acting as a ‘learned
intermediary’ between the manufacturer and the consumer, weighs the potential benefits
against the dangers in deciding whether to recommend the drug to meet the patient’s
needs.” Felix, 540 So. 2d at 104.
9
not “aware of the lack of efficacy of Plavix.” Appellant Br. at 47. Second, she contends
the warnings were inadequate because Mr. LaBarre’s physicians were not warned as to
“the extent to which Plavix increased the risk of bleeding.” Id. Both arguments are
unavailing.
First, Plavix’s efficacy is not relevant to a failure to warn claim. Under Florida
law, a manufacturer’s duty to warn physicians only extends to the risks or dangers posed
by a drug. See MacMurdo, 562 So. 2d at 683; Felix, 540 So. 2d at 104; Buckner, 400 So.
2d at 823; see also Christopher v. Cutter Labs., 53 F.3d 1184, 1192 (11th Cir. 1995)
(noting that, under Florida law, a manufacturer has a duty to provide “an adequate
warning of the risks associated with a prescription product”). Thus, under Florida law
this duty does not extend to a warning about a drug’s efficacy and allowing Ms. LaBarre
“to pursue a claim for the ‘failure to warn’ of the efficacy of a drug would be an
expansion of liability under Florida law,” In re Fosamax Prods. Liab. Litig., No. 1:06-
MD-1789-JFK, 2010 WL 1257299, at *5 (S.D.N.Y. Mar. 26, 2010), which is contrary to
our role when applying state law. See City of Phila. v. Lead Indus. Ass’n, 994 F.2d 112,
123 (3d Cir. 1993) (noting that a federal court sitting in diversity may not act as a
“judicial pioneer” when applying state common law). In short, Plavix’s efficacy is
irrelevant to Ms. LaBarre’s failure to warn claim, and the physicians’ purported lack of
information about it is of no consequence to the adequacy of the warnings.
Second, Ms. LaBarre’s failure to warn claim fails because she has presented no
expert opinion on the subject. To demonstrate inadequate warnings, a plaintiff must
generally show through expert testimony that the warnings were not “adequate to warn a
10
physician of the possibility that [the drug] might be causing the condition experienced.”
MacMurdo, 562 So. 2d at 683; see also Colville, 565 F. Supp. 2d at 1321 (citing
MacMurdo, 562 So. 2d at 683). Accordingly, summary judgment is appropriate on a
failure to warn claim if a plaintiff has not proffered expert testimony on the adequacy of
the warnings. See Paparo v. Ortho McNeil Pharm., No. 05-81044, 2007 WL 121149, at
*4 (S.D. Fla. Jan. 11, 2007); Haggerty v. Upjohn Co., 950 F. Supp. 1160, 1168 (S.D. Fla.
1996). Here, Ms. LaBarre’s expert witness provided no opinions about Plavix’s label or
the adequacy of its warnings. For this additional reason, Ms. LaBarre’s failure to warn
claim fails. 10
C. Ms. LaBarre’s Design Defect Claim
Under Florida law, a manufacturer may be strictly liable for harm resulting from a
product’s defective design. Jennings v. BIC Corp., 181 F.3d 1250, 1255 (11th Cir. 1999).
A design is defective if it renders a product unreasonably dangerous. Id. “A product is
unreasonably dangerous if the risk of danger in the design outweighs the benefits.” In re
Fosamax, 2010 WL 1257299, at *6 (quotation omitted). A design’s defectiveness is
“determined based on an objective standard.” Jennings, 181 F.3d at 1255.
Florida provides an affirmative defense to strict liability for products that are
“incapable of being made safe” so long as they provide a benefit that justifies their use.
10
Ms. LaBarre’s failure to warn claim also fails because she did not prove that a
different warning would have changed Mr. LaBarre’s physician’s recommended course
of treatment. See In re Fosamax Prods. Liab. Litig., 707 F.3d 189, 193 (2d Cir. 2013).
Both of Mr. LaBarre’s physicians testified that they still believe Plavix was an
appropriate treatment for Mr. LaBarre, all things considered. Thus, Ms. LaBarre’s failure
to warn claim also fails as to causation.
11
Restatement (Second) of Torts § 402A, cmt. k (1965); 11 see also Adams v. G.D. Searle &
Co., 576 So. 2d 728, 733 (Fla. Dist. Ct. App. 1991). To invoke this defense, a seller must
establish that: (1) “the product’s benefits must outweigh its known risks as of the date the
product is distributed,” 12 id.; (2) the drug must be “incapable of being made safe,”
Amore, 748 F. Supp. at 854; (3) the drug must be “properly prepared and marketed,” id.;
and (4) the drug must be “accompanied by a proper warning.” Id.
On appeal, Ms. LaBarre focuses on only the first element, arguing that the District
Court erred in finding that comment k applied because there is a genuine dispute as to
whether Plavix’s risks outweigh its benefits. 13 The testimony of Mr. LaBarre’s
11
Comment k provides:
Unavoidably unsafe products. There are some products which, in the
present state of human knowledge, are quite incapable of being made safe
for their intended and ordinary use. These are especially common in the
field of drugs. An outstanding example is the vaccine for the Pasteur
treatment of rabies, which not uncommonly leads to very serious and
damaging consequences when it is injected. Since the disease itself
invariably leads to a dreadful death, both the marketing and the use of the
vaccine are fully justified, notwithstanding the unavoidable high degree of
risk which they involve. Such a product, properly prepared, and
accompanied by proper directions and warning, is not defective, nor is it
unreasonably dangerous.
Restatement (Second) of Torts § 402A, cmt. k (1965). Thus, comment k applies to
products that are unavoidably unsafe but are nonetheless desirable to treat an affliction
that has greater destructive effects. Amore v. G.D. Searle & Co., 748 F. Supp. 748, 854
(S.D. Fla. 1990). Comment k’s applicability must be established by the seller on a case
by case basis. Adams, 576 So. 2d at 733.
12
Courts in Florida have looked to the testimony of treating physicians when
analyzing this element. See Kunzie v. Family Med. Care, P.A., No. 03-3850-CA, 2005
WL 6317652 (Fla. Cir. Ct. Aug. 25, 2005) (applying Adams, 576 So. 2d at 731-33).
13
Ms. LaBarre relies on In re Fosamax Prods. Liab. Litig., No. 1:06-MD-1789-
JFK, 2010 WL 1257299 (S.D.N.Y. Mar. 26, 2010), but the Fosamax court addressed
12
physicians and Dr. Moyé’s expert report supports the District Court’s conclusion that no
reasonable juror could find for Ms. LaBarre on her design defect claim. Mr. LaBarre’s
family physician testified that, considering Plavix’s benefits, the risk of bleeding, and the
risk of not treating a patient’s ACS, Plavix with aspirin was an appropriate course of
treatment for Mr. LaBarre and patients like him. Further, Mr. LaBarre’s cardiologist
testified that: (1) prescribing Plavix and aspirin together, in his experience, had been
effective in reducing the number of heart attacks and stent blockages he sees in his
patients; (2) bleeding complications from the two drugs occurred infrequently; (3)
considering the risks and benefits of Plavix, he believed Plavix with aspirin was an
appropriate treatment for Mr. LaBarre; and (4) he continues to prescribe Plavix and
aspirin, even taking into account the risk of bleeding.
Dr. Moyé’s expert report is not to the contrary. While Dr. Moyé discusses studies
showing that Plavix provides only limited benefits to certain populations of patients and
increases the risk of bleeding, he also states that for patients suffering from ACS, like Mr.
LaBarre, Plavix provides a benefit that is “relatively small but clear,” and at no point
states that the risks of Plavix outweigh its benefits. Accordingly, on this record, the
District Court properly granted summary judgment on this claim.
IV.
whether the product at issue was unreasonably dangerous, which is an element of a
plaintiff’s design defect claim. The Fosamax court did not discuss comment k, which is
an affirmative defense to a design defect claim. By attempting to rely on Fosamax, Ms.
LaBarre conflates an element of her design defect claim—which she must prove—with
an element of the comment k affirmative defense—which the Defendants must prove.
Thus, Fosamax is not relevant to comment k’s applicability in this case.
13
For these reasons, we will affirm the orders of the District Court.
14