## Facts

- Nancy J. Gellner was prescribed Propulsid® by Dr. Daniel W. Wilson, who also provided her samples supplied by the manufacturer’s representatives.
- Gellner died suddenly on the third day after beginning the medication.
- Her estate filed suit in West Virginia circuit court against the drug manufacturers/distributors (Johnson & Johnson-related entities) and Dr. Wilson, asserting inadequate warnings and negligent prescribing/monitoring.
- The manufacturers sought summary judgment, arguing that warnings to the prescribing physician satisfied any duty to warn under the learned intermediary doctrine.
- The circuit court denied summary judgment, concluding West Virginia law did not recognize the learned intermediary doctrine.
- The manufacturers filed an original proceeding seeking a writ of prohibition to prevent the case from proceeding without application of the learned intermediary doctrine.

## Issues

1. Whether a writ of prohibition should issue on the ground that the circuit court exceeded its legitimate powers by refusing to apply the learned intermediary doctrine.
2. Whether West Virginia should adopt the learned intermediary doctrine for prescription drug cases as an exception to a manufacturer’s general duty to warn consumers.

## Decision

- The Supreme Court of Appeals of West Virginia denied the writ of prohibition.
- The court declined to adopt the learned intermediary doctrine in West Virginia.
- The court held that prescription drug manufacturers are subject to the same general duty to warn consumers of product risks as other manufacturers.
- The court reasoned that extraordinary prohibition relief was not justified where the lower court proceeded without applying a doctrine not recognized in West Virginia.

## Legal Principles

- Prohibition is an extraordinary remedy that generally does not issue to correct ordinary legal error; it is reserved for cases where a court lacks jurisdiction or exceeds its legitimate powers.
- In assessing whether a lower court exceeded its legitimate powers, West Virginia applies a multi-factor test that considers, among other things, the availability of adequate alternative remedies and whether the matter presents a clear legal error or an important new legal question.
- West Virginia products-liability law imposes on prescription drug manufacturers a duty to warn consumers of the dangerous propensities of their products.
- West Virginia does not recognize the learned intermediary doctrine as an exception allowing prescription drug manufacturers to discharge their warning duty solely by warning the prescribing physician.
- Policy considerations informing the refusal to adopt the doctrine included changes in drug marketing and information flow, including direct-to-consumer advertising and improved feasibility of communicating risk information directly to patients, as well as reliance on comparative fault principles to allocate responsibility among actors.

## Conclusion

The court refused to use prohibition to require application of an unadopted doctrine and held that West Virginia law imposes a direct duty on prescription drug manufacturers to warn consumers, rejecting the learned intermediary doctrine and allowing the underlying claims to proceed without that defense.


State ex rel. Johnson & Johnson Corp. v. Karl, 220 W. Va. 463, 647 S.E.2d 899 (W. Va. 2007)