Rider v. Sandoz Pharmaceuticals Corp., No. 01-11965.

• Citation: 295 F.3d 1194
• Decision Date: 24 June 2002
• Docket Number: No. 01-11965.,No. 01-11966.
• Parties: Bonnie Joyce RIDER, Walter Anthony Rider, her spouse, Plaintiffs-Appellants, v. SANDOZ PHARMACEUTICALS CORPORATION, a Delaware Corporation, Sandoz Ltd., a Swiss Corp., Sandoz Pharma Ltd., a Swiss Corporation, Defendants-Appellees. Bridget Guthrie Siharath, Plaintiff-Appellant, v. Sandoz Pharmaceuticals Corporation, a Delaware Corporation, Defendant-Appellee.
• Court: United States Courts of Appeals. United States Court of Appeals (11th Circuit)

295 F.3d 1194

Bonnie Joyce RIDER, Walter Anthony Rider, her spouse, Plaintiffs-Appellants, v. SANDOZ PHARMACEUTICALS CORPORATION, a Delaware Corporation, Sandoz Ltd., a Swiss Corp., Sandoz Pharma Ltd., a Swiss Corporation, Defendants-Appellees.

Bridget Guthrie Siharath, Plaintiff-Appellant, v. Sandoz Pharmaceuticals Corporation, a Delaware Corporation, Defendant-Appellee.

No. 01-11965.

No. 01-11966.

United States Court of Appeals, Eleventh Circuit.

June 24, 2002.

Bert Black, Diamond, McCarthy, Taylor & Finley, Dallas, TX, Ellen Relkin, Weitz & Luxenberg, P.C., New York City, for Plaintiffs-Appellants.

Joe G. Hollingsworth, Katharine R. Latimer, Scott S. Thomas, Spriggs & Hollingsworth, Washington, DC, Lawrence J. Myers, Smith Moore LLP, Atlanta, GA, for Defendants-Appellees.

Appeals from the United States District Court for the Northern District of Georgia.

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, 113 S.Ct. 2786, 125 L.Ed.2d 469 (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). 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 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 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, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993); Gen. Elec. Co. v. Joiner, 522 U.S. 136, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997); Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 119 S.Ct. 1167, 143 L.Ed.2d 238 (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, 113 S.Ct. 2786. The Supreme Court identified four factors used to determine the reliability of scientific evidence: 1) whether the theory 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, 113 S.Ct. 2786.

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 141, 118 S.Ct. 512. The Joiner court also established the important test of analytical "fit" between the methodology used and the conclusions drawn. Id at 146, 118 S.Ct. 512. 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, 119 S.Ct. 1167. The expert's conclusions must be based on sound scientific principles and the discipline itself must be a reliable one. Id at 156, 119 S.Ct. 1167. 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, 119 S.Ct. 1167.

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:

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...