IN THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

No. 14-30468

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.

United States Court of Appeals

Fifth Circuit

FILED

April 9, 2015

Lyle W. Cayce

Clerk

 

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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 offlabel-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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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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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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(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-labelpromotion 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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