## Facts

- Two postpartum patients (and one spouse) sued a drug manufacturer, alleging that Parlodel (bromocriptine), prescribed to suppress lactation, caused postpartum hemorrhagic strokes.
- The claims required proof that Parlodel is capable of causing the type of injury alleged (general causation) and that it caused plaintiffs’ injuries.
- After discovery, the defendant moved to exclude plaintiffs’ causation experts under Federal Rule of Evidence 702 and Daubert and sought summary judgment.
- The district court conducted a three-day evidentiary hearing, excluded plaintiffs’ general-causation experts as unreliable, and granted summary judgment for the defendant.
- Plaintiffs appealed; the Eleventh Circuit consolidated the appeals.

## Issues

1. Whether the district court abused its discretion by excluding plaintiffs’ expert testimony on general causation under Rule 702 and Daubert.
2. Whether, with the causation experts excluded, summary judgment for the defendant was proper.

## Decision

- The Eleventh Circuit affirmed the exclusion of plaintiffs’ general-causation experts.
- The court held the proffered opinions were not sufficiently reliable under Daubert and related precedent.
- The court agreed that plaintiffs’ cited materials did not reliably show Parlodel causes postpartum hemorrhagic stroke.
- With no admissible expert evidence on general causation, the court affirmed summary judgment for the defendant.

## Legal Principles

- Under Rule 702, trial courts must act as gatekeepers to admit only expert testimony that is relevant and reliably grounded in scientific methodology.
- Reliability analysis may consider testability, peer review, known or potential error rates, and general acceptance, as applicable to the proffered methods.
- Epidemiological evidence showing association, without adequate support for a causal inference for the specific injury, may be insufficient to establish general causation.
- Case reports and adverse event reports, standing alone, generally cannot establish causation because they are not controlled studies and do not reliably rule out alternative explanations.
- Animal studies and mechanistic hypotheses require reliable scientific reasoning to support extrapolation to humans and to the specific injury; speculative extrapolation does not satisfy Rule 702.
- When a plaintiff’s proof of causation depends on expert testimony, exclusion of that testimony can warrant summary judgment due to failure of proof on an essential element.

## Conclusion

The court affirmed that, in pharmaceutical injury litigation, general-causation opinions must rest on scientifically reliable methods and evidence; because plaintiffs’ experts relied on indirect and methodologically weak materials that did not reliably support a causal link to postpartum hemorrhagic stroke, their testimony was excluded and summary judgment for the manufacturer was affirmed.


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