## Facts

- Ilo Marie Grundberg, prescribed the sedative-hypnotic Halcion (triazolam) for insomnia, shot and killed her 83-year-old mother, Mildred Lucille Coats, in 1988.
- Plaintiffs alleged Grundberg took a 0.5 mg dose consistent with physician directions and the manufacturer’s recommended dosage.
- Plaintiffs alleged the shooting occurred while Grundberg was in a Halcion-induced state causing severe psychiatric effects, including aggressive behavior and homicidal compulsion.
- Plaintiffs sued the manufacturer, The Upjohn Company, asserting negligence and strict products liability theories, including failure to warn and defective design.
- The strict-liability design-defect claim was targeted by a motion for partial summary judgment based on Restatement (Second) of Torts § 402A cmt. k (“unavoidably unsafe products”).
- A federal district court, applying Utah law, certified to the Utah Supreme Court whether and how comment k applies to FDA-approved prescription drugs.

## Issues

1. Whether Utah adopts Restatement (Second) of Torts § 402A cmt. k as an exception to strict products liability for “unavoidably unsafe” products.
2. If adopted, whether comment k applies categorically to FDA-approved prescription drugs, barring strict-liability design-defect claims as a matter of law.
3. Whether an exception exists when FDA approval was obtained through inaccurate, incomplete, misleading, or fraudulent information supplied by the manufacturer.

## Decision

- The Utah Supreme Court adopted comment k and applied it broadly to FDA-approved prescription drugs.
- The court held that an FDA-approved prescription drug, if properly prepared, compounded, packaged, and distributed, cannot be deemed defectively designed under strict liability absent proof the manufacturer tainted FDA approval with inaccurate, incomplete, misleading, or fraudulent information.
- The court’s answer to the certified question would entitle the manufacturer to judgment as a matter of law on the strict-liability design-defect claim if the stated predicates were satisfied.
- The decision left other theories potentially available, including failure-to-warn claims, negligence claims, manufacturing-defect claims, and claims tied to fraud or misrepresentation in the FDA approval process.

## Legal Principles

- Restatement (Second) of Torts § 402A cmt. k can bar strict products-liability design-defect claims for “unavoidably unsafe” products.
- In Utah, FDA-approved prescription drugs are treated as “unavoidably unsafe” as a matter of law for strict design-defect purposes, subject to conditions of proper manufacture and distribution.
- Strict design-defect liability is unavailable absent proof that FDA approval was influenced by inaccurate, incomplete, misleading, or fraudulent information provided by the manufacturer.
- The categorical bar does not foreclose liability based on inadequate warnings, negligent conduct, manufacturing defects, or fraud connected to regulatory approval.

## Conclusion

Utah adopted an expansive comment k rule under which FDA-approved prescription drugs, when properly manufactured and distributed, are categorically insulated from strict-liability design-defect claims unless the plaintiff can show the manufacturer corrupted the FDA approval process with materially false or misleading information.


Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991)