Bonnie Joyce Rider v. Sandoz Pharmaceuticals

                                                                   [PUBLISH]

                  IN THE UNITED STATES COURT OF APPEALS

                        FOR THE ELEVENTH CIRCUIT
                                                               FILED
                          ________________________    U.S. COURT OF APPEALS
                                                        ELEVENTH CIRCUIT
                                                            JUNE 24, 2002
                                  No. 01-11965           THOMAS K. KAHN
                           ________________________           CLERK
                      D. C. Docket No. 95-03068-CV-TWT-1

BONNIE JOYCE RIDER,
WALTER ANTHONY RIDER, her spouse,
                                                           Plaintiff-Appellants,

         versus

SANDOZ PHARMACEUTICALS CORPORATION,
a Delaware Corporation, SANDOZ LTD., a Swiss Corp.,
SANDOZ PHARMA LTD., a Swiss Corporation,

                                                       Defendants-Appellees.

                          ________________________

                                  No. 01-11966
                           ________________________
                      D. C. Docket No. 95-00965-CV-TWT-1

BRIDGET GUTHRIE SIHARATH,
                                                            Plaintiff-Appellant,

versus

SANDOZ PHARMACEUTICALS CORPORATION,
a Delaware Corporation,

                                                           Defendant-Appellee.
                           ________________________

                   Appeals from the United States District Court
                       for the Northern District of Georgia
                         _________________________
                                 (June 24, 2002)


Before ANDERSON, HULL and RONEY, Circuit Judges.

RONEY, Circuit Judge:

      This case involves an issue that has repeatedly come before federal courts:

whether expert testimony purporting to link the drug Parlodel with hemorrhagic stroke

is admissible to prove causation. Bridget Siharath and Bonnie Rider (plaintiffs)

brought this action, alleging that their postpartum hemorrhagic strokes were caused

by ingestion of Parlodel. Defendant Sandoz Pharmaceuticals Company (Sandoz),

maker of Parlodel, moved to suppress the testimony of the plaintiffs’ expert witnesses

and for summary judgment. The district court held that the plaintiffs’ expert

testimony was not sufficiently reliable to meet the standards established by Daubert

v. Merrell Dow Pharm., 509 U.S. 579 (1993), and granted summary judgment in favor

of Sandoz. Plaintiffs appeal. We affirm.

      At the outset, we should point out that this decision does not affirm the

interpretation that the appellants and some of the amici give to the district court’s

opinion at Siharath v. Sandoz Pharm. Corp., 131 F. Supp. 2d 1347 (N.D. Ga. 2001).


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The appellants argue that the district court did not follow the law as prescribed by the

Daubert trilogy, as hereafter set forth, misunderstood the scientific basis for the

opinions sought to be introduced by plaintiffs, and overlooked critical evidence. In

our judgment this is a grossly distorted understanding of the decision of the district

court and is unsupported in the record. This opinion should be read with the

understanding that in our view, with due consideration of alleged incidental problems

with the opinion itself, the district court correctly applied the principles established

in the Daubert trilogy, without modification, and considered all of the voluminous

evidence in the record and all of the evidence taken at a three-day hearing, whether

or not specifically mentioned in the opinion. The district court was unable to find

sufficiently reliable scientific evidence to support a decision that bridged the gap

between the conclusion that Parlodel caused other injuries, which might include

ischemic stroke, and the conclusion that Parlodel was a probable cause of the

hemorrhagic strokes suffered by plaintiffs. We have reviewed the opinion, noted a

problem or two with the opinion itself, considered the arguments in the briefs of both

appellants and amici, and reviewed the record, and conclude that under an unmodified

application of the Daubert trilogy, a proper consideration of every piece of evidence

offered, and a study of the expert opinions themselves, the district court did not abuse




                                           3
its discretion in denying the admission of the testimony of the five expert witnesses

offered by the plaintiffs to prove causation in this case.

                                    I. Background

      Bridget Siharath and Bonnie Rider both took the drug Parlodel to suppress

lactation after childbirth. The active ingredient in Parlodel is bromocriptine, an ergot

alkaloid compound. Both women subsequently suffered hemorrhagic strokes.

      Siharath and Rider filed suit against Sandoz, alleging that Parlodel caused their

hemorrhagic strokes. After discovery, Sandoz moved, in limine, to exclude the

opinions and testimony of the plaintiffs’ experts on causation, and for summary

judgment. Because the motions, documentary evidence, experts, and issues were the

same in both cases, the district court addressed the motions together. The district

court held a Daubert hearing to determine whether the evidence was admissible.

      The district court, in a three-day hearing, examined the evidence presented in

great detail and found that the plaintiffs’ claims were based on speculation and

conjecture rather than the scientific method. The court drew a careful distinction

between clinical process, in which conclusions must be extrapolated from incomplete

data, and the scientific method, in which conclusions must be drawn from an accepted

process, and concluded that the plaintiffs’ experts were relying on the former.

Accordingly, the district court excluded the evidence and granted summary judgment


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in favor of Sandoz. A detailed summary of the facts is fully set forth in the published

district court opinion, Siharath v. Sandoz Pharm. Corp., 131 F. Supp. 2d 1347 (N.D.

Ga. 2001). This appeal followed.

                               II. The Legal Standard

      Toxic tort cases, such as this one, are won or lost on the strength of the

scientific evidence presented to prove causation. For many years the standard for

admissibility of such evidence was the “general acceptance” test set forth in Frye v.

United States, 293 F. 1013 (D.C. Cir. 1923). When the Federal Rules of Evidence

were enacted in 1975, a question arose as to whether the “general acceptance” test had

been supplanted by the reliability test articulated in Rule 702. The question was

resolved in three cases decided by the Supreme Court. Daubert v. Merrell Dow

Pharm., 509 U.S. 579 (1993); Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997); Kumho

Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999). These cases are commonly

referred to as the Daubert trilogy.

      Since Daubert, courts are charged with determining whether scientific evidence

is sufficiently reliable to be presented to a jury. The Daubert court made it clear that

the requirement of reliability found in Rule 702 was the centerpiece of any

determination of admissibility. 509 U.S. at 589. The Supreme Court identified four

factors used to determine the reliability of scientific evidence: 1) whether the theory


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can and has been tested; 2) whether it has been subjected to peer review; 3) the known

or expected rate of error; and 4) whether the theory or methodology employed is

generally accepted in the relevant scientific community. Id at 593-94.

      In Joiner, the Supreme Court established the standard for reviewing trial court

rulings of admissibility, and held that such rulings would be made under an abuse of

discretion standard. 522 U.S. at 517. The Joiner court also established the important

test of analytical “fit” between the methodology used and the conclusions drawn. Id

at 519. The court reasoned that just because a methodology is acceptable for some

purposes, it may not be acceptable for others, and a court may not admit evidence

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

proffered.” Id.

      In Kumho Tire, the Supreme Court made it clear that testimony based solely on

the experience of an expert would not be admissible. 526 U.S. at 157. The expert’s

conclusions must be based on sound scientific principles and the discipline itself must

be a reliable one. Id at 156. The key consideration is whether the expert “employs

in the courtroom the same level of intellectual rigor that characterizes the practice of

an expert in the relevant field.” Id. The court emphasized that judges have

considerable leeway in both how to test the reliability of evidence and determining

whether such evidence is reliable. Id at 151-53.


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      The Daubert trilogy, in shifting the focus to the kind of empirically supported,

rationally explained reasoning required in science, has greatly improved the quality

of the evidence upon which juries base their verdicts.             Although making

determinations of reliability may present a court with the difficult task of ruling on

matters that are outside of its field of expertise, this is “less objectionable than

dumping a barrage of scientific evidence on a jury, who would likely be less equipped

than the judge to make reliability and relevance determinations.” Allison v. McGhan

Med. Corp., 184 F.3d 1300, 1310 (11th Cir. 1999). The district court did not abuse

its discretion in holding that the evidence presented by plaintiffs’ experts does not

meet the standard of reliability.

                       III. The Plaintiffs’ Theory of Causation

      Plaintiffs sought to introduce the testimony of five experts. All five possessed

impressive credentials and were found to be well qualified by the district court, three

over the defendants’ objection. For a summary of the experts’ credentials and

qualifications, see the district court opinion, Siharath, 131 F. Supp. 2d at 1352-54.

Two of the experts, Doctors Kulig and Dukes, testified at the Daubert hearing. The

experts presented a detailed argument for the cause of the plaintiffs’ hemorrhagic

strokes that may be summarized as follows:




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      1) The active ingredient in Parlodel is bromocriptine, a member of the class of

drugs known as ergot alkaloids.

      2) Other ergot alkaloids can cause vasoconstriction, which suggests that

bromocriptine causes vasoconstriction.

      3) Animal studies also suggest that bromocriptine causes vasoconstriction.

      4) Vasoconstriction can cause high blood pressure and ischemic stroke (stroke

caused by decreased blood flow to the brain).

      5) If vasoconstriction and high blood pressure can cause ischemic stroke, it can

also cause hemorrhagic stroke (stroke caused by a rupturing of a blood vessel).

      6) Thus, Parlodel caused the plaintiffs’ hemorrhagic strokes.

                            IV. The Evidence Presented

      The scientific evidence presented by plaintiffs in support of their theory of

causation may be grouped into six categories: 1) epidemiological studies that, on the

whole, may point weakly toward causation; 2) case reports in which injuries were

reported subsequent to the ingestion of Parlodel; 3) dechallenge/rechallenge tests that

implied a relationship between Parlodel and stroke; 4) evidence that ergot alkaloids

(a class of drug that includes bromocriptine) may cause ischemic stroke; 5) animal

studies indicating that under some circumstances, bromocriptine may cause




                                          8
vasoconstriction in dogs and other animals; and, 6) the FDA statement withdrawing

approval of Parlodel’s indication for the prevention of lactation.

                                    A. Epidemiology

       Epidemiology, a field that concerns itself with finding the causal nexus between

external factors and disease, is generally considered to be the best evidence of

causation in toxic tort actions. Plaintiffs presented four epidemiological studies.

Three of the four appear to have found no relationship or a negative relationship

between Parlodel and stroke.          Another may suggest a positive relationship.

Nonetheless, both parties agree that none of the studies present statistically significant

results and that the epidemiological evidence in this case is inconclusive.

       Plaintiffs argue that the district court erred by requiring epidemiological studies,

effectively ruling against them because they could not produce sufficient

epidemiological evidence linking Parlodel to stroke. Having carefully reviewed the

record, we conclude that the district court did not require epidemiological studies.

       It is well-settled that while epidemiological studies may be powerful evidence

of causation, the lack thereof is not fatal to a plaintiff’s case. In Glastetter v. Novartis

Pharm. Corp., 252 F.3d 986 (8th Cir. 2001) and Hollander v. Sandoz Pharm. Corp.,

289 F.3d 1193 (10th Cir. 2002), cases with facts nearly identical to those presented

here, the Eighth and Tenth Circuits affirmed the respective district courts’ exclusion


                                             9
of evidence that Parlodel had caused a hemorrhagic stroke, concluding that the

plaintiffs’ evidence was not sufficiently reliable to be presented to a jury. Those

appellants argued, as the appellants do here, that epidemiological evidence is not

required to prove causation. Both courts properly ruled that it was not required. This

Court has long held that epidemiology is not required to prove causation in a toxic tort

case. See Wells v. Ortho Pharm. Corp., 788 F.2d 741, 745 (11th Cir. 1986) (holding

that “a cause-effect relationship need not be clearly established by animal or

epidemiological studies.”). Accordingly, this case presents the difficult question of

whether the evidence submitted to prove causation, in the absence of epidemiology,

was sufficient to meet the requirements of Daubert.

                                   B. Case reports.

      Much of the plaintiffs’ expert testimony relied on case reports in which patients

suffered injuries subsequent to the ingestion of Parlodel. Although a court may rely

on anecdotal evidence such as case reports, Allison, 184 F.3d at 1312, courts must

consider that case reports are merely accounts of medical events. They reflect only

reported data, not scientific methodology. Some case reports are a very basic form

report of symptoms with little or no patient history, description of course of treatment,

or reasoning to exclude other possible causes. The contents of these case reports were




                                           10
inadequate, even under the plaintiffs’ expert’s standards, to demonstrate a relationship

between a drug and a potential side effect.

      Some case reports do contain details of the treatment and differential diagnosis.

Even these more detailed case reports, however, are not reliable enough, by

themselves, to demonstrate the causal link the plaintiffs assert that they do because

they report symptoms observed in a single patient in an uncontrolled context. They

may rule out other potential causes of the effect, but they do not rule out the

possibility that the effect manifested in the reported patient’s case is simply

idiosyncratic or the result of unknown confounding factors. As such, while they may

support other proof of causation, case reports alone ordinarily cannot prove causation.

See, e.g., Haggerty v. Upjohn Co., 950 F. Supp. 1160, 1165 (S.D. Fla. 1996) (stating

that “while case reports may provide anecdotal support, they are no substitute for a

scientifically designed and conducted inquiry.” (citation omitted)), aff’d without op.,

158 F.3d 588 (11th Cir. 1998). The record demonstrates that the district court

carefully considered the case reports and properly concluded that the case reports did

not by themselves provide reliable proof of causation.

                          C. Dechallenge/rechallenge Data

      Plaintiffs’ experts provided dechallenge/rechallenge data that they argue

suggests a link between Parlodel and stroke. A test is a “dechallenge” test when a


                                          11
drug that is suspected of causing a certain reaction is withheld to see if the reaction

dissipates. The drug may then be reintroduced in a “rechallenge” to see if the reaction

reoccurs. These reports, which may be analogized to controlled studies with one

subject, can be particularly useful in determining whether a causal relationship exists.

Nonetheless, because none of the studies involved a patient with the particular injury

suffered by the plaintiffs, they do not provide data useful in determining whether

Parlodel caused the plaintiffs’ injuries.

       On appeal, plaintiffs presented two dechallenge/rechallenge reports that they

assert are particularly convincing evidence of causation. In one, a woman developed

severe headaches and hallucinations while taking bromocriptine. All symptoms

disappeared when the drug was withheld. When bromocriptine was readministered,

she complained of chest pain and tests revealed total occlusion of a coronary artery.

One month later, she was given the drug again and tests revealed a seventy percent

arterial constriction. This report indicates at best a relationship between Parlodel and

localized arterial spasm. Plaintiffs have presented insufficient evidence on which the

district court could have concluded that this report is evidence that Parlodel causes

systemic vasoconstriction, high blood pressure, or hemorrhagic stroke.

       The other report presented by the plaintiffs involves a woman who reported

partial paralysis in her left arm and left leg after taking her first dose of Parlodel. Her


                                            12
symptoms disappeared shortly thereafter, and she did not take Parlodel again until her

physician was present. Upon taking the drug again, she experienced essentially the

same symptoms. Plaintiffs imply that this report is relevant because the woman’s

symptoms were a result of stroke. A careful review of this report, however, reveals

that it does not provide any evidence that the patient suffered a stroke, let alone

evidence that Parlodel caused a stroke. Both neurologists who examined the patient

questioned whether her symptoms were real and reported that the most likely cause

of her symptoms was psychosomatic. One neurologist opined that if the symptoms

were real, it was possible that her symptoms were a result of hypotension, or decreased

blood pressure. Because the plaintiffs’ causation argument relies on a conclusion that

Parlodel causes high blood pressure, this report does not provide reliable evidence in

support of their theory.

      Thus, these dechallenge/rechallenge reports suggest at most a possibility that

Parlodel may cause localized vasoconstriction, and may suggest that it causes

hypotension. They cannot be considered reliable evidence of a relationship between

Parlodel and stroke because neither of them involve stroke.                 Moreover,

dechallenge/rechallenge tests are still case reports and do not purport to offer

definitive conclusions as to causation.




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      Plaintiffs   argue    that   the    district   court   completely     ignored    the

dechallenge/rechallenge reports before it. This overstates the case. The district court

discussed several of the case reports by way of example, and concluded that they were

unreliable as evidence that Parlodel causes hemorrhagic stroke. The case reports that

discussed dechallenge and rechallenge evidence were not sufficiently related to the

case at hand to merit further discussion. Of the seven such reports emphasized by the

plaintiffs, three did not arise postpartum – a significant fact since risk of stroke is

greatly increased in the postpartum period. Of the four arising postpartum, three did

not discuss dechallenge/rechallenge evidence related to stroke or seizure, but only as

to other suspected effects of Parlodel – hypertension, coronary (not cerebral)

vasospasm and occlusion, hallucinations, and headache. This Court’s discussion of

the dechallenge/rechallenge reports relied upon by the plaintiffs demonstrates that the

district court did not abuse its discretion in holding that they are not reliable evidence

of a link between Parlodel and hemorrhagic stroke.

                                D. Chemical Analogies

      Bromocriptine is one of many drugs in a class known as ergot alkaloids.

Plaintiffs sought to introduce evidence that because other ergot alkaloids cause

vasoconstriction, then it is proper to conclude bromocriptine must do so as well.

There is an insufficient basis in the record for this Court to hold that the district court


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abused its discretion by not drawing such a conclusion. Ergot alkaloids encompass

a broad class of drugs with great chemical diversity, and “[e]ven minor deviations in

chemical structure can radically change a particular substance’s properties and

propensities.” Glastetter, 252 F.3d at 990 (citation omitted). The district court, after

a detailed review of the properties of ergot alkaloids, concluded that plaintiffs failed

to come forward with even a theory as to why the mechanism that causes some ergot

alkaloids to act as vasoconstrictors would more probably than not be the same

mechanism by which bromocriptine acts to cause vasoconstriction. The district court

did not abuse its discretion in doing so.

                                  E. Animal Studies

      Plaintiffs offered evidence of animal studies in which bromocriptine

demonstrated vasoconstrictive properties in dogs and certain other animals. Plaintiffs

did not offer any animal studies that suggest that bromocriptine causes stroke, or even

high blood pressure. The district court discussed each of these studies and was within

its discretion in concluding that plaintiffs offered insufficient evidence on which that

court could base a conclusion that the effect of bromocriptine would be the same on

humans as it is on animals.

                                  F. FDA Findings




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      Plaintiffs presented evidence that the FDA issued a statement withdrawing

approval of Parlodel’s indication for the prevention of lactation. The district court

concluded that the language in the FDA statement itself undermined its reliability as

proof of causation. In the statement, the FDA did not purport to have drawn a

conclusion about causation. Instead, the statement merely states that possible risks

outweigh the limited benefits of the drug. This risk-utility analysis involves a much

lower standard than that which is demanded by a court of law. A regulatory agency

such as the FDA may choose to err on the side of caution. Courts, however, are

required by the Daubert trilogy to engage in objective review of evidence to determine

whether it has sufficient scientific basis to be considered reliable. The district court

did not abuse its discretion in concluding that the FDA actions do not, in this case,

provide scientific proof of causation.

          V. Applying the Evidence to the Plaintiffs’ Theory of Causation

      The deficiencies in the evidence reveal three gaps in the causal argument

advanced by the plaintiffs. First, plaintiffs suggest that because bromocriptine is an

ergot alkaloid, it causes vasoconstriction. Although some other ergot alkaloids do

cause vasoconstriction, plaintiffs offered insufficient evidence for the district court to

find that bromocriptine does so as well. This is not a case where the Court finds the




                                           16
evidence offered to be unreliable. In this case the record contains no evidence at all

of this hypothesis. Instead, it contains principally speculation and conjecture.

      Because the ergot alkaloid class of drugs has a wide range of effects, it is not

obvious that bromocriptine should have the same effects as other drugs in that class.

Indeed, two widely-reported symptoms associated with bromocriptine are vasodilation

and hypotension, precisely the opposite of what the plaintiffs allege. Plaintiffs did

offer a theory as to why the drug might cause either vasodilation or vasoconstriction,

depending on the vascular characteristics of the patient, a theory that the defendants

concede the district court did not correctly explain in its opinion. This minor error

does not affect the correctness of the district court’s conclusion however, because the

plaintiffs did not offer sufficiently reliable evidence to support their theory.

      Second, the plaintiffs urge the Court to extrapolate the results of animal studies

to humans. As with the plaintiffs’ evidence of chemical properties, the district court

did not err in finding no basis for doing so. Plaintiffs’ experts admitted that with

respect to animal studies generally, what happens in an animal would not necessarily

happen in a human being. Accordingly, it is necessary for plaintiffs to offer some

rationale for the suggestion that the vascular structures of humans and animals are

sufficiently similar in this context to conclude that bromocriptine’s effects on animals

may be extrapolated to humans. Plaintiffs have not done so.


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       As the Supreme Court held in Joiner, scientific evidence must “fit” the

plaintiff’s theory of causation. In this case, neither the chemical compound evidence

nor the animal study evidence “fits” as evidence relevant to the cause of plaintiffs’

injuries.

       Third, plaintiffs argue that because there is some evidence that bromocriptine

causes ischemic stroke, it also causes hemorrhagic stroke. This is the most untenable

link in the causal chain. Strokes are broadly classified into two categories: ischemic

and hemorrhagic. Ischemic strokes occur as a result of lack of blood flow to the brain.

Hemorrhagic strokes occur as a result of bleeding within the brain. Thus, although the

two conditions share a name, they involve a wholly different biological mechanism.

The evidence that suggests that Parlodel may cause ischemic stroke does not apply to

situations involving hemorrhagic stroke. This is a “leap of faith” supported by little

more than the fact that both conditions are commonly called strokes. Plaintiffs argue

that as a result of the vasoconstriction caused by Parlodel, blood pressure may

increase to the point that blood vessels in the brain rupture. Plaintiffs have offered no

reliable evidence that Parlodel increases blood pressure to such dangerous levels.

Even if they had, they failed to offer proof of how such an increase in blood pressure

can precipitate a hemorrhagic stroke.




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      Since the shortcomings in the evidence render the theory unreliable, the district

court did not abuse its discretion in excluding the plaintiffs’ evidence of causation.

                                     V. Conclusion

      In the absence of epidemiology, plaintiffs may still prove medical causation by

other evidence. In the instant case, however, plaintiffs simply have not provided

reliable evidence to support their conclusions. To admit the plaintiffs’ evidence, the

Court would have to make several scientifically unsupported “leaps of faith” in the

causal chain. The Daubert rule requires more. Given time, information, and

resources, courts may only admit the state of science as it is. Courts are cautioned not

to admit speculation, conjecture, or inference that cannot be supported by sound

scientific principles. “The courtroom is not the place for scientific guesswork, even

of the inspired sort. Law lags science; it does not lead it.” Rosen v. Ciba-Geigy

Corp., 78 F.3d 316, 319 (7th Cir. 1996).

      Plaintiffs argue that the district court erred in requiring a checklist of types of

evidence to prove causation. This argument misinterprets the district court’s opinion.

The district court, after finding that the plaintiffs’ evidence was unreliable, noted that

certain types of other evidence may have been considered reliable, including peer-

reviewed epidemiological literature, a predictable chemical mechanism, general

acceptance in learned treatises, or a very large number of case reports. In so doing,


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the district court was not compiling a list of required types of evidence. Rather, it was

highlighting the plaintiffs’ failure to present evidence in any of several categories that

would have been persuasive.

      Plaintiffs also argue that the district court ignored important evidence. As a

preliminary matter, this Court has considered the evidence the plaintiffs allege was

ignored and has found nothing upon which to base a conclusion that Parlodel causes

hemorrhagic stroke. The Court also notes that it has no reason to believe that the

district court did not examine the entire record in this case. On the contrary, there is

every indication that the district court correctly stated in its opinion that it had

carefully “reviewed the massive volume of documentary evidence (in all, about 575

exhibits, depositions and affidavits) that relates to Plaintiffs’ expert testimony on

medical causation. The Court’s ruling is based on both the testimony from the

Daubert hearing and the substantial documentary evidence in the record.” 131 F.

Supp. 2d at 1350. The district court held a three-day hearing in which two of the

plaintiffs’ experts were allowed to testify and were subjected to cross-examination.

The district court’s twenty-five page published opinion meticulously discusses the

evidence and considers whether it was reliable, concluding after a thorough analysis

that it was not.




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      The district court’s conclusion is in conformity with numerous other decisions.

Two circuit court opinions have addressed the issue of Parlodel and hemorrhagic

stroke. See Glastetter v. Novartis Pharm. Corp., 252 F.3d 986 (8th Cir. 2001);

Hollander v. Sandoz Pharm. Corp., 289 F.3d 1193 (10th Cir. 2002). Both courts,

presented with facts and evidence nearly identical to what is presented here, affirmed

the district courts’ exclusion of the plaintiffs’ scientific evidence as unreliable. There

are at least four district court opinions involving Parlodel that, despite slight

differences in facts or evidence, reach the same ultimate result. See Caraker v. Sandoz

Pharm. Corp., 188 F. Supp. 2d 1026 (S.D. Ill. 2001); Douglas v. Sandoz Pharm.

Corp., 2000 WL 33342286 (M.D.N.C. 2000); Brumbaugh v. Sandoz Pharm. Corp.,

77 F. Supp. 2d 1153 (D. Mont. 1999). Two Parlodel cases in which the evidence of

causation of injury was admitted involved injuries different from the hemorrhagic

strokes alleged in the instant case. Brasher v. Sandoz Pharm. Corp., 160 F. Supp. 2d

1291 (N.D. Ala. 2001) (admitting evidence that Parlodel caused ischemic stroke);

Globetti v. Sandoz Pharm. Corp., 111 F. Supp. 2d 1174 (N.D. Ala. 2000) (admitting

evidence that Parlodel caused acute myocardial infarction).

      We hold that the district court did not abuse its discretion in concluding that the

Plaintiffs’ scientific proof of causation is legally unreliable and inadmissible under the

standards set by the Daubert trilogy.


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AFFIRMED.




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