Opinion

TEXAS COURT OF APPEALS, THIRD DISTRICT, AT AUSTIN

NO. 03-98-00231-CV

Willie Roy Revels, Individually and as Next Friend of Brandon Revels, Bradley Revels,

and Breon Revels; and Rev. Billy and Neldon Lindley, Appellants

v.

Novartis Pharmaceuticals Corporation f/k/a Sandoz Pharmaceuticals Corporation;

St. David's Health Care System, Inc. d/b/a St. David's Medical Center;

and Mary E. Gasal, M.D., Appellees

FROM THE DISTRICT COURT OF TRAVIS COUNTY, 201ST JUDICIAL DISTRICT

NO. 95-11076, HONORABLE PETER M. LOWRY, JUDGE PRESIDING

This is a wrongful death action based on medical negligence and product liability.

Appellants, Willie Roy Revels, individually and as next friend of Brandon, Bradley, and Breon

Revels, the Reverend Billy Lindley, and Neldon Lindley, alleged that Carolyn Revels's (1) ingestion

of the drug Parlodel caused her death. The trial court granted appellees' (2) motion for summary

judgment on the ground that appellants failed to provide admissible evidence of causation to

support their causes of action. We will affirm the trial court's judgment.

BACKGROUND

Carolyn Revels daily ingested five milligrams of the drug Parlodel to suppress

lactation after the birth of her third son, Breon. Two weeks after Breon was born, while talking

on the telephone to her father, Mrs. Revels suffered a cardiac arrhythmia resulting in sudden

death. The medical examiner attributed Mrs. Revels's death to cardiomyopathy, an enlarged

heart, which occurred during the postpartum period. According to the medical examiner, the

precise cause of postpartum cardiomyopathy is unknown to medical science. She also found

evidence of cardiohypertrophy, which is a thickening of the heart muscle, and of sarcoidosis,

which is an immune disorder characterized by granulomas in the body's organs. The medical

examiner stated in her report that she believed Mrs. Revels's heart failure was more likely related

to the postpartum cardiomyopathy and not the sarcoidosis.

Appellants dispute the medical examiner's report. They believe that Mrs. Revels

suffered a Parlodel-induced coronary artery vasospasm, which caused cardiac arrhythmia, that led

to her heart failure and death. Appellants filed suit against Novartis, the manufacturer of Parlodel;

Dr. Gasal, the doctor who prescribed the drug to Mrs. Revels; and St. David's, the facility that

provided the drug to Mrs. Revels. Appellants offered seven expert witnesses to testify regarding

general causation, meaning that Parlodel could cause coronary artery vasospasm in the general

population, and regarding specific causation, meaning that Parlodel caused Mrs. Revels to suffer

a coronary artery vasospasm. See Merrell Dow Pharmaceuticals, Inc. v. Havner , 953 S.W.2d

706, 714 (Tex. 1997) (explaining difference between general and specific causation).

Appellees each filed a motion to exclude appellants' causation testimony, alleging

that the expert testimony failed to meet the admissibility requirements of Texas Rule of Evidence

702. The trial court granted appellees' motions, stating in its order:

The methodology supporting the opinions of these experts is not sufficiently

scientifically reliable or relevant to satisfy the requirements of Texas Rule of Civil

Evidence 702 as set forth by the Texas Supreme Court in E.I. du Pont de Nemours

& Co. v. Robinson , 923 S.W.2d 549 (Tex. 1995); and Merrell Dow

Pharmaceuticals, Inc. v. Havner , 953 S.W.2d 706 (Tex. 1997); see also Daubert

v. Merrell Dow Pharmaceuticals, Inc ., 509 U.S. 579 (1993).

Appellees subsequently filed motions for summary judgment on the basis that

appellants could provide no admissible evidence to establish that Parlodel caused Mrs. Revel's

death. See Tex. R. Civ. P. 166a(i). The trial court granted the motions, rendering judgment that

appellants take nothing from any appellee. Appellants appeal the trial court's grant of summary

judgment, contending in three issues that the trial court abused its discretion by excluding their

experts' testimony regarding causation and erred by granting each appellee's motion for summary

judgment.

DISCUSSION

Standard of Review

The decision to admit or exclude evidence rests within the sound discretion of the

trial court. See E.I. du Pont de Nemours & Co. v. Robinson , 923 S.W.2d 549, 558 (Tex. 1995).

The test for abuse of discretion is whether the trial court acted without reference to any guiding

rules or principles. See id. The Texas Supreme Court has held that the trial court acts as a

gatekeeper when it comes to the admissibility of expert testimony; the trial court's role is to make

the initial determination whether the expert's opinion is relevant and whether the methods and

research upon which it is based are reliable. See id.

The factors a trial court should consider in determining the admissibility of expert

evidence include, but are not limited to, the following: (1) the extent to which the theory has been

or can be tested; (2) the extent to which the technique relies upon the subjective interpretation of

the expert; (3) whether the theory has been subjected to peer review and publication; (4) the

technique's potential rate of error; (5) whether the underlying theory or technique has been

generally accepted as valid by the relevant scientific community; and (6) the non-judicial uses that

have been made of the theory. Id . at 557. The factors used to determine whether the proffered

evidence is sufficiently reliable differ with each case. See id. When properly considered, this

Court cannot conclude that a trial court abused its discretion, even if, in the same circumstances,

we would have ruled differently. See id . at 558.

Appellants' Causation Evidence

Appellants' experts opined that Parlodel could cause vasospasms in the general

population based upon their review of pharmacological actions of structurally similar compounds

and of numerous case reports associating Parlodel with adverse side effects. The experts testified

that they formed the opinion that Parlodel caused Mrs. Revels to suffer a coronary artery

vasospasm by employing a process known as differential diagnosis, that is, by reviewing her

medical records and in their opinion excluding all other possible causes of death.

Parlodel's active ingredient is bromocriptine mesylate, a semi-synthetic ergot

alkaloid. Ergot alkaloids have the ability to cause vasospasm. In its notice of a proposal to

withdraw approval for the use of Parlodel in suppressing lactation, the Food and Drug

Administration ("FDA") noted:

In the general population, a risk factor for hypertensive crises and spasms is

exposure to ergot alkaloids. Bromocriptine is a semi-synthetic ergot alkaloid . . .

. It is therefore possible that bromocriptine may . . . like other ergot alkaloids .

. . precipitate pregnancy-induced hypertension, or other related adverse events.

Bromocriptine Mesylate (Parlodel) for the Prevention of Physiological Lactation; Opportunity for

a Hearing on a Proposal to Withdraw Approval of the Indication, 59 Fed. Reg. 43,347 , 43,351

(1994).

In addition to their review of the pharmacological actions of ergot alkaloids,

appellants' experts reviewed a number of adverse events connected to the use of Parlodel that have

been reported to the FDA. Adverse event reports are spontaneous reports by health professionals

of serious problems that occur with medical products, such as drugs, once the product has been

approved by the FDA for widespread use. A physician who suspects that a medical product may

be related to a serious event may submit an adverse event report to the FDA. See Food and Drug

Administration, The Clinical Impact of Adverse Event Reporting 2 (October 1996). These

unsolicited adverse event reports contain "uncontrolled" information, as opposed to clinical trial

data, which are obtained under strictly controlled conditions. See id. at 5 . The adverse events

reports related to Parlodel usage include incidents of postpartum hypertension, seizures, and

strokes.

In 1994, the FDA withdrew approval for the use of Parlodel for postpartum

lactation suppression. By way of explanation, the FDA noted that by 1989, it had received eighty-five serious adverse event reports associated with bromocriptine, including ten involving patient

deaths. The FDA went on to note:

The agency concluded that, although the individual ADEs [adverse drug

experiences] did not prove that bromocriptine caused hypertensive crises, seizures,

or [strokes], in the aggregate, the ADEs suggested that bromocriptine may be the

cause of these serious adverse experiences . . . .

59 Fed. Reg. 43,347 , 43,348 (1994). The FDA notice concluded that "the potential risks

associated with the use of bromocriptine for the prevention of physiological lactation outweigh its

limited benefits and bromocriptine is no longer shown to be safe for the use in preventing

physiological lactation." Id . at 43,351.

Appellants' experts also reviewed over twenty published case reports by physicians

associating an adverse event to the ingestion of Parlodel. These reports include such adverse side

effects as hair loss, digital artery vasospasm, hypertension, and cerebral vascular accidents

(strokes) and myocardial infarctions (heart attacks) in postpartum women. The reports do not

purport to prove a causal relationship between the drug and the adverse event, but merely record

the physician's observations of a particular patient, and note the possible association between the

drug and the event.

Appellants point to one report of a bromocriptine challenge/re-challenge test as

direct scientific proof of causation. See F. Larrazet, et. al., Possible Bromocriptine-Induced

Myocardial Infarction , 118 Annals of Internal Medicine 199 (February 1993). In the two-page

Larrazet report, the author describes his experiment on a thirty-two year old woman taking

Parlodel to suppress lactation. The woman took a 2.5 milligram dose of Parlodel and two hours

later, "at the peak of action of bromocriptine," the physician observed a seventy percent

constriction of her right coronary artery. See id. The author noted that "[t]he mechanism by

which bromocriptine could have precipitated coronary artery spasm is not clear." Id . at 200. The

author concludes with language similar to most case reports reviewed by appellants' experts:

"Our study suggests that bromocriptine should be considered as a possible etiologic agent causing

postpartum myocardial infarction." Id .

Appellees objected to the reliability of appellants' general causation testimony,

arguing that a review of structurally similar compounds and of a series of individual case reports

was insufficient to satisfy the reliability test established by the Texas Supreme Court in Robinson

and Havner . They argued further that, absent reliable evidence of general causation, appellants'

experts had no basis for their opinions regarding specific causation. In other words, in order for

the experts to exclude other causes of death and conclude that Parlodel caused Mrs. Revels's

death, there must first exist some reliable theory of general causation to warrant the inclusion of

Parlodel ingestion as a possible cause of her death.

Application of Robinson and Havner to Appellants' Causation Evidence

In Robinson , the supreme court reviewed the trial court's decision to exclude expert

evidence, while in Havner , the court evaluated whether the expert testimony at issue was

sufficiently reliable to constitute some evidence of causation. While Havner spoke specifically to

the epidemiological evidence offered in that case, it provides some guidance for the cause before

us. In particular, the court states that case reports are not "scientifically reliable" evidence and

should be rejected as a basis on which an expert may base his or her opinion. See Havner , 953

S.W.2d at 720 . The court reasons that "physicians following scientific methodology would not

examine a patient or several patients in uncontrolled settings to determine whether a particular

drug has favorable effects, nor would they rely on case reports to determine whether a substance

is harmful." See id . (citing David E. Bernstein, The Admissibility of Scientific Evidence After

Daubert v. Merrell Dow Pharmaceuticals, Inc., 15 Cardozo L. Rev. 2139 , 2148-49 (1994)).

Although appellants' experts relied on a large number of case reports associating Parlodel with

adverse experiences, the supreme court has indicated that a study of case reports alone is a

scientifically invalid manner in which to form an expert opinion:

A physician, even a treating physician, or other expert who has seen a skewed data

sample, such as one of a few infants who has a birth defect, is not in a position to

infer causation. The scientific community would not accept as methodologically

sound a "study" by such an expert reporting that the ingestion of a particular drug

by the mother caused the birth defect.

Id . at 719-20; see also Minnesota Mining & Mfg. Co. v. Atterbury , 978 S.W.2d 183, 199 (Tex.

App.--Texarkana 1998, pet. denied) (under the supreme court's standards in Havner , published

peer-reviewed case reports probably not sufficiently reliable to support causation testimony).

The supreme court recognized that when the research and the expert's opinion are

formed for the purpose of litigation, this weighs against the admissibility of the expert testimony.

See Robinson , 923 S.W.2d at 559 . Here, two of appellants' experts testified that they were not

familiar with the drug Parlodel before they were asked to review Mrs. Revels's file for purposes

of this litigation. A third expert relied on several of his own case reports he prepared in

conjunction with Parlodel litigation.

While the case reports illustrate an association between adverse drug experiences

and Parlodel, the supreme court has clearly warned that such an association does not equate to

causation. See Havner , 953 S.W.2d at 718, 724 . Most of the adverse event case reports at issue

here describe experiences other than coronary artery vasospasm, the alleged cause of Mrs.

Revels's death. Even the Larrazet challenge/re-challenge experiment, appellants' strongest

evidence of general causation, constitutes but one single, uncontrolled experiment.

Before Robinson and Havner , the evidence on which appellants' experts relied

might well have been adequate to bring their opinions before the jury. However, now the supreme

court has given the lower courts directives and invested the trial courts with considerable

discretion to determine admissibility of expert testimony, and we must uphold that decision if the

court properly exercised its discretion. It was within the trial court's discretion to exclude

appellants' expert testimony regarding general causation on the grounds that the basis for the

testimony was not sufficiently reliable under the Robinson test. Thus, we must hold that in the

absence of a scientifically reliable basis for a conclusion regarding general causation, the trial

court did not abuse its discretion by excluding expert testimony that Parlodel was the specific

cause of Mrs. Revels's death. See Havner , 953 S.W.2d at 720 .

Despite the suggestion of a relationship between adverse experiences and Parlodel

usage, we are called upon only to determine whether the trial court abused its discretion in light

of the guidelines provided by our supreme court regarding the admissibility of expert witness

testimony. We may not substitute our judgment for that of the trial court, nor may we reverse the

trial court's ruling even when this Court would have ruled differently. When we compare

appellants' scientific evidence with the directives of the supreme court in Robinson and Havner ,

we cannot conclude that the trial court abused its discretion by excluding appellants' causation

evidence. Because appellants presented no admissible evidence of causation, an essential element

in their claims against appellees, the trial court did not err by rendering summary judgment in

appellees' favor. Appellants' issues one, two, and three are overruled.

CONCLUSION

The judgment of the trial court is affirmed.

Marilyn Aboussie, Chief Justice

Before Chief Justice Aboussie, Justices Jones and B. A. Smith

Affirmed

Filed: August 26, 1999

Do Not Publish

1. Carolyn Revels was the wife of Willie Roy Revels, the mother of Brandon, Bradley, and

Breon Revels, and the daughter of the Reverend Billy and Neldon Lindley.

2. Appellees are Novartis (f/k/a Sandoz) Pharmaceuticals Corporation ("Novartis"), St.

David's Health Care System, Inc. d/b/a St. David's Medical Center ("St. David's"), and Mary

E. Gasal, M.D. Novartis, St. David's and Dr. Gasal will be referred to collectively as

"appellees."

ientifically invalid manner in which to f