## Facts

- Carolyn Bryant had hypertension and atrial fibrillation and was treated by a cardiologist.
- In 1997, her physician prescribed Betapace (sotalol) and later increased its dosage.
- The physician then prescribed Posicor, a calcium channel blocker manufactured by Hoffmann-La Roche, for high blood pressure/angina.
- On August 26, 1997, Carolyn took Betapace doses in the morning and at noon and took Posicor for the first time mid-morning.
- Later that day, she was found at the bottom of stairs and suffered severe brain injuries.
- Her husband, Clyde Bryant, individually and as executor, sued Hoffmann-La Roche alleging negligence, breach of warranty, strict liability/design defect, and loss of consortium.
- The theory of liability was that Posicor was defectively designed and inadequately tested and that its interaction with Betapace caused or contributed to the collapse and injuries.
- Bryant offered expert testimony supporting defective design, inadequate premarketing testing, and causation via drug interaction.

## Issues

1. Whether the claims were federally preempted because they effectively asserted an impermissible “fraud on the FDA” theory.
2. What legal standard governs Georgia prescription-drug design-defect claims, including whether a risk–utility analysis applies.
3. Whether exclusion of Bryant’s expert testimony and the resulting grant of summary judgment on all claims were proper.

## Decision

- The Court of Appeals of Georgia reversed the grant of summary judgment for Hoffmann-La Roche and remanded.
- The court held the claims were not preempted because they were traditional state tort and warranty theories seeking recovery for patient harm, not enforcement of federal regulatory duties.
- The court held that prescription-drug design-defect claims are evaluated under a risk–utility analysis.
- The court concluded Bryant’s expert evidence was admissible and sufficient to create genuine issues of material fact on defect, testing, and causation, precluding summary judgment.

## Legal Principles

- State-law negligence, strict liability, and warranty claims based on defective design/testing are not preempted merely because the product is regulated by the FDA; preemption applies where the theory depends on proving fraud on the FDA as the basis of liability.
- Georgia evaluates prescription-drug design-defect claims under a risk–utility framework.
- In applying risk–utility to prescription drugs, relevant considerations include whether the drug was properly manufactured, carried sufficient warnings, whether benefits justify risks, and whether a safer alternative design existed at the time of manufacture.
- Competent expert testimony that a prescription drug was defectively designed or inadequately tested and that the defect caused injury generally creates a triable fact dispute and defeats summary judgment.

## Conclusion

The appellate court held that Georgia drug design-defect claims require a risk–utility balancing and that Bryant’s traditional tort and warranty claims were not barred as “fraud on the FDA”; because the plaintiff’s expert evidence created fact disputes on defect and causation, summary judgment for the manufacturer was reversed and the case remanded.


Bryant v. Hoffmann-La Roche, Inc., 585 S.E.2d 723 (Ga. Ct. App. 2003)