IN THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

No. 09-50244

MAX WELLS, 

 Plaintiff - Appellant

versus

SMITHKLINE BEECHAM CORPORATION, doing business as

GlaxoSmithKline,

 Defendant - Appellee

Appeal from the United States District Court

for the Western District of Texas

Before HIGGINBOTHAM, GARZA, and PRADO, Circuit Judges.

PATRICK E. HIGGINBOTHAM, Circuit Judge:

Max Wells invoked diversity jurisdiction and complained that

GlaxoSmithKline had failed to warn him that one of its drugs – Requip – could

make him gamble away millions. In support, Wells proffered testimony from

three experts who would opine that Requip can cause pathological gambling in

the general population. The company moved for summary judgment, arguing

that the experts’ testimony did not pass scientific muster. The district court

agreed – holding that even if the court admitted the expert testimony, the

opinions would not suffice to create a fact question about general causation,

United States Court of Appeals

Fifth Circuit

F I L E D

March 22, 2010

Charles R. Fulbruge III

Clerk

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No. 09-50244

Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993). 1

2

because the experts’ conclusions were not scientifically reliable. Wells appealed,

and we affirm on the alternative Daubert ground presented to us: because the 1

experts’ opinions are not scientifically reliable, the testimony is inadmissible –

leaving the liability cupboard bare.

I.

A.

Doctor Max Wells ran a successful pathology clinic but in 2000 fell ill with

Parkinson’s disease. Wells began taking Mirapex, a drug made by an unrelated

third-party manufacturer. Mirapex is a type of “dopamine agonist,” a class of

drugs that stimulates the dopamine receptors in the brain to alleviate symptoms

of Parkinson’s. Due to the neurological disease’s progression, Wells had to sell

part of his clinic in 2001, and in 2002 he retired. In 2005, Wells sold his

remaining interest in the clinic for a sizeable sum.

Since the 1970s, Wells had traveled regularly to Las Vegas. He enjoyed

gambling, and he claims to have kept his losses under control. After his

diagnosis, though, Wells began to lose more and more money. In 2004, he talked

to his doctor about an article he saw warning that Mirapex might cause problem

gambling. At that point Wells had already lost as much as $2 million. In

response, his doctor in October 2004 prescribed Wells a different dopamine

agonist – this time Requip (generically called ropinirole), the drug at issue in

this case. Requip’s label did not warn about gambling.

Wells’s gambling urges temporarily subsided but then came back with a

vengeance. From September 2005 (when he received final payment on the sale

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 Some of these losses came from online gambling. 2

 GlaxoSmithKline refers to itself as GSK, a convention we adopt. 3

 The parties interchangeably call the gambling problem “compulsive” and 4

“pathological,” but the medically proper term is “pathological.”

 Both parties agree that Texas substantive law applies in this diversity case. 5

See Ackermann v. Wyeth Pharms., 526 F.3d 203, 208 (5th Cir. 2008) (invoking Texas 6

law); see also Wright v. Ford Motor Co., 508 F.3d 263, 275 (5th Cir. 2007) (same). “The

Supreme Court of Texas, like many courts, has equated the ‘more-likely-than-not’ causation

requirement to a more than 50% probability that a defendant’s wrongful conduct caused the

harm or injury.” Young v. Mem’l Hermann Hosp. Sys., 573 F.3d 233, 235 (5th Cir. 2009) (per

curiam) (citing Merrell Dow Pharms., Inc. v. Havner, 953 S.W.2d 706, 715–17 (Tex. 1997)).

Knight v. Kirby Inland Marine Inc., 482 F.3d 347, 351 (5th Cir. 2007) (citing Havner,

7

953 S.W.2d at 714) (quotation marks omitted).

See id.

8

3

of his clinic) until January 2006, Wells surrendered $10 million to the Nevada

gaming tables – including $4 million in January alone. He told his doctor about 2

the gambling problem, stopped taking Requip, and has not been back to Vegas.

B.

Wells sued GlaxoSmithKline, the manufacturer of Requip, alleging that

GSK had failed to warn patients about the side effect of pathological gambling. 3 4

For Wells to win under Texas law, he must show that the failure to warn caused 5

his injury. Causation has two levels, general and specific, and a plaintiff must 6

prove both. “General causation is whether a substance is capable of causing a

particular injury or condition in the general population, while specific causation

is whether a substance caused a particular individual’s injury.” Sequence 7

matters: a plaintiff must establish general causation before moving to specific

causation. Without the predicate proof of general causation, the tort claim fails.8

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Riverwood Int’l Corp. v. Employers Ins. of Wausau, 420 F.3d 378, 382 (5th Cir. 2005). 9

Berquist v. Wash. Mut. Bank, 500 F.3d 344, 349 (5th Cir. 2007). 10

4

Wells engaged three expert witnesses to address causation, that Requip

can cause pathological gambling. In reaching their conclusions, the experts

relied upon: (1) published articles documenting case-specific correlations

between Requip and gambling; (2) a single unpublished study showing a nexus

between Parkinson’s medicines generally and gambling; (3) GSK’s internal data

revealing case-specific associations between Requip and gambling; and (4) the

fact that GSK has since changed the Requip label to warn about possible

gambling side-effects. Each of the three experts, though, conceded that there

exists no scientifically reliable evidence of a cause-and-effect relationship

between Requip and gambling.

The company moved for summary judgment, arguing: (1) that the expert

opinions did not meet Daubert’s admissibility requirements; or, alternatively, (2)

that the lack of scientifically reliable data supporting general causation

precluded recovery under Texas law. The district court assumed the expert

testimony’s admissibility, but found that the experts did not support Wells’s

claim with scientifically reliable evidence of causation as required by Texas law.

Wells appealed the summary judgment. Our review is de novo, applying

the same standards as the district court. We may affirm on any grounds 9

supported by the record.10

II.

A.

Daubert requires admissible expert testimony to be both reliable and

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Knight, 482 F.3d at 352 (citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 11

589 (1993)).

Daubert, 509 U.S. at 592–93. 12

Id. at 590. 13

Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). 14

Knight, 482 F.3d at 351 (citing Daubert, 509 U.S. at 593). 15

Id. (citing Daubert, 509 U.S. at 593). 16

See Kumho Tire Co., 526 U.S. at 150. 17

5

relevant. “This entails a preliminary assessment of whether the reasoning or 11

methodology underlying the testimony is scientifically valid and of whether that

reasoning or methodology properly can be applied to the facts in issue.”12

Although there are “no certainties in science,” the expert must present

conclusions “ground[ed] in the methods and procedures of science.” In short, 13

the expert must “employ[ ] in the courtroom the same level of intellectual rigor

that characterizes the practice of an expert in the relevant field.”14

“[T]he Supreme Court [has] delineated certain factors to assist courts in

evaluating the foundation of a given expert’s testimony, though the Court

carefully emphasized the nonexhaustive nature of the listing.” Suggested 15

considerations include: “whether the theory or technique the expert employs is

generally accepted; whether the theory has been subjected to peer review and

publication; whether the theory can and has been tested; whether the known or

potential rate of error is acceptable; and whether there are standards controlling

the technique’s operation.” There is no formula, and the court must judge 16

admissibility based on the particular facts of the case.17

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 171 F.3d 308, 309 (5th Cir. 1999). 18

6

B.

Wells proffered the testimony of three experts: Doctors Fong, Saklad, and

Kalechstein. None did more than baldly state that Requip can cause problem

gambling. At their depositions, the three admitted that no scientific basis

existed to confirm their conclusions.

Fong explained: “I think fundamentally there is something very compelling

and interesting going on here, but we don’t have enough data to suggest

causality . . . . I have not come to a conclusion that there is a causal relationship

between Requip and pathological gambling.” He further testified that – based

on the “scientific standard that [he] appl[ies] in [his] practice as a psychiatrist

and a research scientist” – the scientific literature did not establish a “causeand-effect relationship between Requip and pathological gambling.”

Saklad’s deposition went the same way. He was asked: “Applying the

scientific standard for cause and effect, has – has a cause-and-effect relationship

been established between taking Requip and having one or more impulse-control

disorders considered as a collective group?” He answered: “No.”

A bit more hesitant at first, Kalechstein ultimately fell in line with Fong

and Saklad: “I cannot say [Requip] directly causes [pathological gambling].

What I can say is that there is an association between the two variables. . . .

[T]hat’s different than talking about the issue of causation.”

Under the law of this circuit, these admissions drain the expert opinions

of probative force. In Black v. Food Lion, Inc., the plaintiff claimed that she

slipped in the defendant’s store and that the fall caused fibromyalgia

syndrome. The district court admitted the plaintiff’s proffered expert, and we 18

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Id. at 312. 19

Id. (quotation marks omitted); see also id. at 313 n.2. 20

See Daubert, 509 U.S. at 589–90. 21

Knight v. Kirby Inland Marine Inc., 482 F.3d 347, 352 (5th Cir. 2007). 22

See, e.g., Burleson v. Tex. Dep’t of Criminal Justice, 393 F.3d 577, 586 (5th Cir. 2004) 23

(“Here, as in Allen, there are no epidemiological studies supporting a correlation between the

suggested causative agent and the type of cancer experienced by the plaintiff.”); Allen v. Pa.

Eng’g Corp., 102 F.3d 194, 197 (5th Cir. 1996) (“While appellants’ experts acknowledge the

7

reversed on Daubert grounds for abuse of discretion. We explained that the

expert’s testimony did “not bear the necessary indicia of intellectual rigor.”19

While “association” was well established, “experts have recognized that the

evidence that trauma actually causes fibromyalgia is insufficient to establish

causal relationships.” Given the experts’ concessions in this case, Black 20

controls – and we need not go any further. However, sensitive to the casespecific nature of the Daubert inquiry, we will closely examine the experts’

methodology.

C.

The experts based their general causation conclusion primarily on the

scientific literature, which they claim shows an association between Requip and

problem gambling. The literature, though, does not provide the necessary

“scientific knowledge” upon which to base an opinion under Daubert. Doctor 21

Fong characterized all but one of the studies as “anecdotal evidence,” and each

expert conceded that the studies were not statistically significant epidemiology.

They were, in fact, case studies. Although, “[c]ase-control studies are not per se

inadmissible evidence on general causation,” this court has frowned on 22

causative conclusions bereft of statistically significant epidemiological support.23

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lack of statistically significant epidemiological evidence, they rely on certain studies as

‘suggestive’ of a link between EtO exposure and brain cancer. ‘Suggestiveness’ is not by the

experts’ own admission statistical significance . . . ; this basis for their scientific opinion must

be rejected.”).

 D ANIEL WEINTRAUB ET AL., DOPAMINERGIC THERAPY AND IMPULSE CONTROL 24

DISORDERS IN PARKINSON’S DISEASE: A CROSS-SECTIONAL STUDY OF OVER 3,000 PATIENTS

(2008) (summarizing an epidemiological study presented at a conference).

Daubert, 509 U.S. at 593. 25

See Knight, 482 F.3d at 353 (affirming rejection of a “study focused on organic

26

solvents as a class, including a wide-range of chemicals to which [the plaintiffs] were never

exposed”); see also Burleson, 393 F.3d at 585–86 (affirming rejection of a study showing that

exposure to a substance causes cancer but not showing that the specific type of exposure

suffered by the plaintiff could lead to his particular type of cancer); Allen, 102 F.3d at 197

(affirming rejection of a study showing that exposure to carcinogen caused a different type of

cancer than the one suffered by plaintiff).

8

Only one study – the Weintraub Poster – reached statistical significance. 24

The Poster suggests that Parkinson’s patients medicated with dopamine

agonists exhibit increased impulsive behavior, including pathological gambling.

But the study has other scientific problems making it insufficient as a basis for

expert opinion. First, “submission to the scrutiny of the scientific community is

a component of ‘good science,’” but the Weintraub Poster was never peerreviewed or published. Second, the study explains that its results “represented 25

a class association, as opposed to a specific medication, finding.” In other words,

the Weintraub Poster does not report a “controlled” test for Requip, a drug that

functions differently than other dopamine agonists. Finally, its authors 26

conceded that the very “nature of the study precluded determination of

causality.”

While “[w]e . . . understand that in epidemiology hardly any study is ever

conclusive, and we do not suggest that an expert must back his or her opinion

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Knight, 482 F.3d at 354. 27

Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). 28

 One of Wells’s experts, Dr. Saklad, explained in his deposition that “causation

29

requires scientific literature that proves a statistically valid reproducible result which could

be used to establish causation. Such studies have not been done.”

 It bears mentioning that, in addition to the literature, Wells’s experts purport to rely 30

on GSK’s internal documentation in reaching the conclusion that Requip causes problem

gambling. Specifically, GSK has, over the years and per the FDA’s requirements, collected

data on patients suffering increased gambling when taking Requip. This data shows a

relatively high number of self-reported spikes, but mining this data is not the scientific

method; rather, it is rife with bias and variability. Wells also points out that GSK has now

changed its Requip label to warn about possible gambling problems. This precaution, though,

did not grow out of scientific knowledge of causation; rather, GSK changed the label because

there might be an association. See 21 C.F.R. § 201.80(e) (“The labeling shall be revised to

include a warning as soon as there is reasonable evidence of an association of a serious hazard

with a drug; a causal relationship need not have been proved.”).

See Kumho Tire Co. v. Carmichael, 526 U.S. 137, 141 (1999) (describing Daubert as 31

“setting forth the trial judge’s general ‘gatekeeping’ obligation”).

9

with published studies that unequivocally support his or her conclusions,” here 27

“there is simply too great an analytical gap between the data and the opinion

proffered.” And the bases for the experts’ conclusions pass none of the 28

applicable Daubert tests: that Requip causes problem gambling is not generally

accepted, has not been subjected to peer review and publication, and is not 29

backed by studies meeting requisite scientific standards. Without the expert 30

testimony, Wells cannot prove general causation – and judgment must be

entered for GSK.

III.

Our conclusion that the trial court did not abuse its discretion is an

unremarkable sustaining of the district court’s gatekeeping role under Daubert.

31

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 The Supreme Court of Texas has explained that “the same factors may be applied” 32

to “no evidence review of scientific evidence” as to review of admissibility of scientific

testimony. Merrell Dow Pharms., Inc. v. Havner, 953 S.W.2d 706, 714 (Tex. 1997) (referencing

E.I. du Pont de Nemours & Co. v. Robinson, 923 S.W.2d 549, 556–57 (Tex. 1995) (adopting the

federal Daubert standard in the Texas-law inquiry into the admissibility of expert testimony));

id. at 712 (explaining that scientific sufficiency in Texas “is determined by looking at

numerous factors including those set forth in . . . Daubert”).

See Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996) (“Law lags science; 33

it does not lead it.”).

10

In finding the evidence scientifically unreliable – and thus insufficient to prove

causation under Texas law – it follows that the experts’ testimony was also

deficient under Daubert given its overlap with Texas questions of scientific

sufficiency.32

Perhaps Requip is a cause of problem gambling, but the scientific

knowledge is not yet there. Wells urges the law to lead science – a sequence not

countenanced by Daubert. And while the possibilities of their relationship 33

properly spark concerns sufficient to warrant caution, the courts must await its

result. AFFIRMED.

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