Rider v. Sandoz Pharmaceutical Corp.
295 F.3d 1194 (11th Cir. 2002)

Facts:

  • Bridget Siharath and Bonnie Rider both took the drug Parlodel to suppress lactation after childbirth. 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.
  • Plaintiffs sought to introduce the testimony of five experts, and the scientific evidence presented to support their theory of causation was grouped into six categories:
    • 1) Epidemiological studies that, on the whole, may point weakly toward causation.
      • 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.
    • 2) Case reports in which injuries were reported subsequent to the ingestion of Parlodel.
      • 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.
    • 3) Dechallenge/rechallenge tests that implied a relationship between Parlodel and stroke.
      • A test is a “dechallenge” test when a drug that is suspected of causing a certain reaction is withheld to see if the reaction dissipates.
    • 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 vasoconstriction in dogs and other animals.
    • 6) The FDA statement withdrawing approval of Parlodel’s indication for the prevention of lactation.

History:
The district court held that the plaintiffs’ expert testimony was not sufficiently reliable to meet the standards established by Daubert.

  • Note: Daubert is a Supreme Court case that charges courts with determining whether scientific evidence is sufficiently reliable to be presented to a jury. 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.

Issue:
Whether expert testimony purporting to link the drug Parlodel with hemorrhagic stroke was admissible to prove causation.

Holding:
No. Affirmed.

Reasoning:

  • The court ultimately held that the plaintiffs did not provide reliable evidence to support their conclusions:
    • 1) Epidemiological studies: Both parties agreed that none of the studies present statistically significant results and that the epidemiological evidence in this case is inconclusive.
    • 2) Case reports: These alone ordinarily cannot prove causation.
    • 3) Dechallenge/rechallenge tests: 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.
    • 4) Evidence that ergot alkaloids (a class of drug that includes bromocriptine) may cause ischemic stroke;
      • Ergot alkaloids encompass a broad class of drugs with great chemical diversity, and even minor deviations in chemical structure can radically change a particular substance’s properties and propensities.
    • 5) Animal studies indicating that under some circumstances, bromocriptine may cause vasoconstriction in dogs and other animals;
      • Plaintiffs did not offer any animal studies that suggest that bromocriptine causes stroke, or even high blood pressure.
    • 6) The FDA statement withdrawing approval of Parlodel’s indication for the prevention of lactation.
      • 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. A regulatory agency such as the FDA may choose to err on the side of caution.

Rule: In determining whether scientific evidence is sufficiently reliable, courts are cautioned not to admit speculation, conjecture, or inference that cannot be supported by sound scientific principles – courts may NOT make several scientifically unsupported “leaps of faith” in the causal chain.