Filed: Apr. 09, 2015
Latest Update: Mar. 02, 2020
Summary: Case: 14-30468 Document: 00513000269 Page: 1 Date Filed: 04/09/2015 IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT United States Court of Appeals Fifth Circuit FILED April 9, 2015 No. 14-30468 Lyle W. Cayce Clerk JOSHUA A. WHITENER, SR., Individually and on Behalf of His Minor Child Lucas C. Whitener; LINDSEY C. WHITENER, Individually and on Behalf of Her Minor Child Lucas C. Whitener, Plaintiffs - Appellants v. PLIVA, INCORPORATED, formerly known as Pliva USA, Incorporated; PLIVA H
Summary: Case: 14-30468 Document: 00513000269 Page: 1 Date Filed: 04/09/2015 IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT United States Court of Appeals Fifth Circuit FILED April 9, 2015 No. 14-30468 Lyle W. Cayce Clerk JOSHUA A. WHITENER, SR., Individually and on Behalf of His Minor Child Lucas C. Whitener; LINDSEY C. WHITENER, Individually and on Behalf of Her Minor Child Lucas C. Whitener, Plaintiffs - Appellants v. PLIVA, INCORPORATED, formerly known as Pliva USA, Incorporated; PLIVA HR..
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Case: 14-30468 Document: 00513000269 Page: 1 Date Filed: 04/09/2015
IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT United States Court of Appeals
Fifth Circuit
FILED
April 9, 2015
No. 14-30468
Lyle W. Cayce
Clerk
JOSHUA A. WHITENER, SR., Individually and on Behalf of His Minor Child
Lucas C. Whitener; LINDSEY C. WHITENER, Individually and on Behalf of
Her Minor Child Lucas C. Whitener,
Plaintiffs - Appellants
v.
PLIVA, INCORPORATED, formerly known as Pliva USA, Incorporated;
PLIVA HRVATSKA D.O.O.; BARR LABORATORIES, INCORPORATED;
BARR PHARMACEUTICALS, L.L.C.; WATSON PHARMACEUTICALS,
INCORPORATED; TEVA PHARMACEUTICAL INDUSTRIES, LIMITED;
SCHWARZ PHARMA, INCORPORATED, now known as UCB, Incorporated;
ALAVEN PHARMACEUTICAL, L.L.C.; MEDA PHARMACEUTICALS,
INCORPORATED,
Defendants - Appellees
Appeal from the United States District Court
for the Eastern District of Louisiana
USDC No. 2:10-CV-1552
Before JOLLY, WIENER, and CLEMENT, Circuit Judges.
PER CURIAM:*
* Pursuant to 5th Cir. R. 47.5, the court has determined that this opinion should not
be published and is not precedent except under the limited circumstances set forth in 5th Cir.
R. 47.5.4.
Case: 14-30468 Document: 00513000269 Page: 2 Date Filed: 04/09/2015
No. 14-30468
Lindsey Whitener’s son was born prematurely and with birth defects
after she was prescribed metoclopramide to treat the nausea and morning
sickness she experienced while pregnant. Mrs. Whitener, joined by her son
and husband, sued various pharmaceutical entities, alleging that those entities
had promoted the prescription of metoclopramide to treat morning sickness,
an “off-label” use. The district court dismissed the Whiteners’ claim as to each
defendant. Because the Whiteners have failed to show that any alleged off-
label-promotional activities engaged in by the defendants caused their injuries,
we AFFIRM.
I.
Early in her pregnancy, Mrs. Whitener visited her doctor, Dr. John
McCrossen, complaining of nausea and morning sickness. Dr. McCrossen
prescribed metoclopramide. Metoclopramide is the generic equivalent of the
brand-name drug Reglan. Its Federal Drug Administration-approved label
does not indicate that it is used to treat morning sickness. After Mrs. Whitener
used metoclopramide throughout her pregnancy, her son was born
prematurely and with severe birth defects.
In 2010, the Whiteners sued various pharmaceutical entities, alleging,
first, that the defendants had failed to warn that metoclopramide could be
dangerous when taken during pregnancy; and, second, that the defendants had
promoted the prescription of metoclopramide to treat nausea and morning
sickness in pregnancy, a dangerous, “off-label” use. Three of the defendants—
PLIVA, Inc., Barr Laboratories, Inc., and Teva Pharmaceutical Industries,
Ltd.—manufactured generic metoclopramide, the product that Mrs. Whitener
used. Three of them—Alaven Pharmaceutical L.L.C., Meda Pharmaceuticals,
Inc., and Schwarz Pharma, Inc.—manufactured brand-name Reglan, a product
that Mrs. Whitener did not use.
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No. 14-30468
In 2011, the Supreme Court held in PLIVA, Inc. v. Mensing that, because
federal law requires generic drug labels to be the same at all times as
corresponding brand-name drug labels, state-law inadequate-warning claims
based on a generic-drug manufacturer’s failure to provide a more adequate
label are preempted. 131 S. Ct. 2567, 2577–78 (2011). Following Mensing,
certain defendants filed a motion for judgment on the pleadings, asserting that
the Whiteners’ claims were preempted. The district court agreed that, to the
extent the Whiteners’ claims were based on the generic-manufacturing
defendants’ failure to change metoclopramide’s label to warn of the danger of
taking it during pregnancy, they were preempted. But to the extent the
Whiteners’ claims were based on the defendants’ affirmative promotion of
metoclopramide for use during pregnancy, the district court was unwilling “to
conclude that such a claim fails as a matter of law.”
The Whiteners amended their complaint to assert more clearly the
remaining claim—off-label promotion. Teva Ltd.—which, it is undisputed, is
an Israeli corporation with a principal place of business in Israel—moved to
dismiss for lack of personal jurisdiction, and the district court granted the
motion. The remaining defendants moved for summary judgment, arguing
that the Whiteners’ off-label-promotion claim was not a viable, non-preempted
one under Louisiana law; and that, even if it were, the Whiteners could not
establish that any promotional activities engaged in by the defendants had
caused their injuries. The district court assumed for the argument asserted
that the off-label promotion claim was viable. Nonetheless, it granted
summary judgment, concluding that Dr. McCrossen’s deposition testimony
indicated that his “decision to prescribe the drug to Mrs. Whitener was his
own” and was made “independently of any alleged conduct by the” defendants.
The Whiteners appealed, challenging the district court’s grant of Teva
Ltd.’s motion to dismiss for lack of personal jurisdiction and its dismissal on
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No. 14-30468
summary judgment of their off-label-promotion claim against the other
defendants and their other claims against the brand-name manufacturers.
II.
We first address the Whiteners’ appeal of the district court’s grant of
Teva Ltd.’s motion to dismiss for lack of personal jurisdiction. Both in the
district court and on appeal, the Whiteners have contended that general
personal jurisdiction exists over Teva Ltd. But as the Supreme Court has held
and this court has recently recognized, it is the “exceptional case” in which “a
corporation’s operations in a forum other than its formal place of incorporation
or principal place of business may be so substantial and of such a nature as to
render the corporation” subject to general jurisdiction “in that State.” Daimler
AG v. Bauman, 134 S. Ct. 746, 761 n.19 (2014); see Monkton Ins. Servs., Ltd.
v. Ritter,
768 F.3d 429, 432 (5th Cir. 2014) (“It is . . . incredibly difficult to
establish general jurisdiction in a forum other than the place of incorporation
or principal place of business.”). Nothing in the record shows that Teva Ltd.’s
contacts with Louisiana are “‘continuous and systematic’ enough” to make this
such an “exceptional case.”
Monkton, 768 F.3d at 432. Furthermore, because
the Whiteners identify no evidence that they are likely to discover that would
call our lack of personal jurisdiction into question, the district court did not
abuse its discretion in denying the Whiteners’ motion for additional
jurisdictional discovery. See
id. at 434; see also Fielding v. Hubert Burda
Media, Inc.,
415 F.3d 419, 428 (5th Cir. 2005) (“A district court’s discovery
decision will be reversed only if . . . the appellant demonstrates prejudice
resulting from the decision.”). Accordingly, we AFFIRM the district court’s
grant of Teva Ltd.’s motion to dismiss, essentially for the reasons given by the
district court.
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III.
We turn next to the district court’s grant of summary judgment to the
remaining defendants. We review the district court’s grant of summary
judgment de novo, applying the same standard as the district court. Chaney
v. Dreyfus Serv. Corp., 595 F.3d 219, 228–29 (5th Cir. 2010). Under that
standard, 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 applying this standard,
we “view[] all facts in the light most favorable to the nonmovant and draw[] all
reasonable inferences in the nomovant’s favor.” Rice v. ReliaStar Life Ins. Co.,
770 F.3d 1122, 1129 (5th Cir. 2014). But we are “not required to accept the
nonmovant’s conclusory allegations, speculation, and unsubstantiated
assertions which are either entirely unsupported, or supported by a mere
scintilla of evidence.”
Chaney, 595 F.3d at 229.
A.
Many of the arguments made by the remaining defendants vary.
Although the defendants all assert that the Whiteners’ off-label-promotion
claim is not a viable, non-preempted one under Louisiana law, they give
different reasons why this is so. The defendants who manufacture generic
metoclopramide argue, among other things, that the off-label-promotion claim
is simply a failure-to-warn claim in a different guise, and thus that it is
preempted under Mensing. The defendants who manufacture brand-name
Reglan, citing our decisions in Johnson v. Teva Pharm. USA, Inc., 758 F.3d 605
(5th Cir. 2014), and Demahy v. Schwarz Pharma, Inc.,
702 F.3d 177 (5th Cir.
2012) (per curiam), argue that the only claims the Whiteners may assert
against them are those arising under the Louisiana Products Liability Act
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No. 14-30468
(LPLA), and that, under that statute, they cannot be held liable because Mrs.
Whitener did not use their product. The Whiteners counter each argument. 1
Despite the variation in their several arguments, however, one argument
is common to all defendants: regardless of whether the Whiteners’ off-label-
promotion claim is characterized as arising under the LPLA or under general
Louisiana tort law, the Whiteners can recover only if they show causation—
that is, they must show that, but for the defendants’ off-label promotion of
metoclopramide for use by pregnant women, Mrs. Whitener would not have
ingested it. See Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 260–61 (5th Cir.
2002) (“To maintain a successful . . . action under the LPLA, a plaintiff must
establish . . . that the claimant’s damage was proximately caused by a
characteristic of the product . . . .” (emphasis added)); Banks v. N.Y. Life Ins.
Co., 98-0551 (La. 7/2/99);
737 So. 2d 1275, 1282 (“In a tort action, [the] plaintiff
bears the burden of proving by a preponderance of the evidence . . . a causal
1 The Whiteners also argue that we need not reach whether the district court properly
granted summary judgment on the merits. Instead, the Whiteners suggest, we should
remand on the ground that the district court abused its discretion in not granting their
motion for additional discovery before it granted summary judgment to the defendants. See
Fed. R. Civ. P. 56(d); see also Freudensprung v. Offshore Tech. Servs., Inc., 379 F.3d 327, 347
(5th Cir. 2004) (“[W]e . . . review a district court’s decision to deny a discovery request for
abuse of discretion.”).
To succeed on a Rule 56(d) motion, however, the party requesting discovery must
provide an affidavit or declaration in support of the request that “state[s] with some precision
the materials he hope[s] to obtain with further discovery, and exactly how he expect[s] those
materials w[ill] assist him in opposing summary judgment.” Krim v. BancTexas Grp., Inc.,
989 F.2d 1435, 1443 (5th Cir. 1993). The Whiteners’ Rule 56(d) declaration did not mention
how the Whiteners expect the discovery materials would help them oppose summary
judgment. The declaration only incorporated by reference the Whiteners’ arguments on this
point from their memorandum in opposition to certain defendants’ motion for summary
judgment. But while the Whiteners’ memorandum emphasized that discovery would
substantiate their theory that the defendants influenced Dr. McCrossen’s decision to
prescribe metoclopramide through an indirect, “complex scheme,” see infra p. 8, it made no
mention of any specific materials that would accomplish that feat. In short, the district court
did not abuse its discretion in denying the Whiteners’ Rule 56(d) motion.
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connection between the injury and the tort.” (emphasis added)). The district
court held that the Whiteners could not show causation because Dr.
McCrossen’s testimony indicates that his decision to prescribe metoclopramide
to Mrs. Whitener was uninfluenced by the alleged promotional activities of the
defendants. This holding is not error. We therefore affirm the district court’s
dismissal of the Whiteners’ claim as to all remaining defendants without
reaching whether the Whiteners’ off-label-promotion claim is a viable theory of
recovery. 2
B.
In his deposition, Dr. McCrossen testified at length as to why he
prescribed metoclopramide to treat Mrs. Whitener’s morning sickness. This
testimony is unequivocal: he prescribed metoclopramide to Mrs. Whitener not
because any defendant suggested that he do so, but because, in his “clinical
experience,” metoclopramide “works good to control nausea and vomiting
associated with pregnancy.” Indeed, Dr. McCrossen’s testimony makes clear
that he could not have been directly influenced by the defendants to promote
metoclopramide to pregnant women. He testified that he had never had any
contact with the defendants or their representatives with regard to
metoclopramide; that “[n]o one ha[d] specifically talked to [him] from a
company about Reglan or Metoclopramide”; and that samples of the drug were
never left at his office or, to his knowledge, provided to anyone else in his
practice. Thus, the record is clear that it was Dr. McCrossen’s “clinical . . .
judgment” and “experience”—and not any promotional activities on the part of
the defendants—that led him to prescribe metoclopramide to Mrs. Whitener.
2 To the extent that the Whiteners raise other claims against the brand-name
defendants alleging that they caused the FDA’s mislabeling of Reglan and metoclopramide,
these claims are foreclosed by Johnson. See 758 F.3d at 614–16 & n.3.
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Conceivably, as the Whiteners point out, they might nonetheless survive
summary judgment if they showed that Dr. McCrossen’s clinical judgment was
itself influenced, in some indirect way, by the defendants’ promotional
activities. The Whiteners, however, make no such showing. Instead, they only
argue that the defendants engaged in a “complex scheme to promote
metoclopramide through congresses, doctors and medical journals.” But
evidence of such a “complex scheme”—as opposed to “conclusory allegations,
speculation, and unsubstantiated assertions,” Chaney, 595 F.3d at 229—does
not appear in the record.
* * *
Given Dr. McCrossen’s testimony, the district court correctly held that
there was no genuine issue of material fact to bar the defendants’ motions for
summary judgment. The failure to show causation, sadly, sinks all claims of
the Whiteners. See Stahl, 283 F.3d at 260–61;
Banks, 737 So. 2d at 1282.
Accordingly, the judgment of the district court is
AFFIRMED.
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