J.C., a Minor by and Through His Mother and Next Friend, Michelle C., and I.H., a Minor by and Through Her Mother and Next Friend, Angela H. v. Pfizer, Inc., Roerig, a Division of Pfizer, Inc., and Greenstone, LLC f/k/a Greenstone, Ltd.

Summary

The Supreme Court of Appeals of West Virginia affirmed summary judgment for Pfizer in claims alleging that Zoloft caused birth defects and that Pfizer failed to provide an adequate warning. The court held that, under the circumstances, expert testimony was required to establish the adequacy of the drug’s warning because the issues involved complex scientific, medical, and regulatory matters beyond the common knowledge of jurors. The plaintiffs’ withdrawal of their labeling expert left them unable to prove an essential element of their claims.

Holdings

1. In a failure-to-adequately-warn claim involving complex medical, scientific, epidemiological, and regulatory issues concerning a prescription-drug label, expert testimony is required when the issues are beyond the common knowledge and experience of the average juror. Whether expert testimony is necessary is determined case by case, not under a categorical rule that applies to every products-liability claim.
2. Compliance with applicable regulations is competent evidence of due care, although FDA approval of the Zoloft label does not itself resolve liability.
3. The plaintiffs could not meet their evidentiary burden on the adequacy of the Zoloft label through attorney interpretation of company documents, animal studies, epidemiological materials, adverse-event reports, Core Data Sheets, FDA regulations, or testimony from Pfizer witnesses lacking the necessary labeling opinions.
4. Summary judgment for Pfizer was proper because the plaintiffs lacked expert testimony necessary to prove that Pfizer's warning was inadequate.

Questions Presented

1. Whether expert testimony was required to establish that Pfizer's 2003 Zoloft label inadequately warned of risks associated with use during pregnancy.
2. Whether the plaintiffs could satisfy their evidentiary burden through company documents, product labels, and testimony from Pfizer witnesses rather than through their own labeling expert.
3. Whether summary judgment was proper when the plaintiffs lacked expert testimony on the adequacy of the warning.

Disposition

affirmed