## Facts

- Harvey Hale Rice sought treatment for back pain and received prescriptions for Xanax (alprazolam) and Tylenol #3 from his physician, who warned him the drugs would be sedating and that he should not fly, drive, or operate machinery.
- The next evening, after taking the medications, Rice argued with his wife and shot himself; he died shortly thereafter.
- Toxicology reported Xanax, Tylenol/codeine, and meprobromate (a central nervous system depressant) in Rice’s system.
- Sharon L. Shanks, as personal representative of Rice’s estate, sued the manufacturer alleging Xanax was a substantial factor in the suicide and asserted theories including strict-liability design defect and strict-liability failure to warn (including failure to warn of suicidal ideation and hostile behavior).
- Evidence at trial conflicted on whether Xanax can contribute to suicidality and whether the warnings provided to prescribers were adequate.

## Issues

1. Whether prescription drugs are categorically exempt from strict-liability design-defect claims.
2. What standard governs strict-liability design-defect claims for prescription drugs (including the role of physician expectations and risk–benefit analysis).
3. Whether instructing the jury in negligence terms on a pleaded strict-liability failure-to-warn claim is reversible error.
4. Whether a negligence-per-se theory based on Alaska’s Food, Drug and Cosmetic Act, AS 17.20.290(a)(1), should proceed.
5. Whether attorney’s fees and costs were properly assessed against the estate and how fee issues should be handled after reversal.

## Decision

- Reversed the judgment for the manufacturer and remanded for a new trial on strict-liability design defect and strict-liability failure to warn.
- Held prescription drugs are not categorically immune from strict-liability design-defect claims; blanket protection based on comment k was rejected.
- Held the trial court’s failure-to-warn instructions improperly framed strict liability in negligence terms, materially misstating the law and prejudicing the plaintiff.
- Affirmed rejection of the negligence-per-se theory; it did not require retrial.
- Vacated the award of attorney’s fees and costs and remanded fee issues for reconsideration in light of the reversal on the merits.

## Legal Principles

- Prescription drug manufacturers in Alaska may be held strictly liable for design defects; there is no across-the-board exemption for all prescription drugs.
- Design-defect liability for prescription drugs is evaluated through a risk–benefit approach informed by the learned-intermediary doctrine, focusing on whether the drug performed as safely as an ordinary physician would expect when used as intended or foreseeably.
- Strict-liability failure-to-warn claims are doctrinally distinct from negligence; jury instructions that ask only whether a “reasonably prudent manufacturer” acted reasonably misstate strict liability and can require a new trial.
- A negligence-per-se claim requires a statute that supplies an appropriate civil standard for tort liability; AS 17.20.290(a)(1) did not provide such a standard on these facts.
- When a merits judgment is reversed, related fee and cost awards dependent on that judgment must be vacated and reconsidered on remand.

## Conclusion

The court required a new trial because Alaska law permits strict-liability design-defect claims against prescription drug manufacturers under a physician-focused risk–benefit standard, and because strict-liability failure-to-warn claims cannot be tried under negligence-based jury instructions; the negligence-per-se theory was rejected and the fee award was vacated.


Shanks v. Upjohn Co., 835 P.2d 1189 (Alaska 1992)