Bryant v. Hoffmann-La Roche, Inc.
262 Ga. App. 401, 51 U.C.C. Rep. Serv. 2d (West) 422, 585 S.E.2d 723 (2003)
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Rule of Law:
In Georgia, prescription drug manufacturers are subject to strict liability for design defects under a risk-utility analysis, and Comment k of the Restatement (Second) of Torts § 402A, which addresses unavoidably unsafe products, serves as an affirmative defense rather than a complete bar to such claims.
Facts:
- In 1997, Carolyn Bryant was treated by Dr. Harold D. Carlson for cardiac problems, including hypertension and atrial fibrillation, for which she was prescribed Betapace, a beta-blocking drug.
- On August 18, 1997, Dr. Carlson increased Mrs. Bryant's dosage of Betapace.
- On August 25, 1997, Dr. Carlson also prescribed Posicor, a new heart medication manufactured by Hoffmann-La Roche, Inc.
- On August 26, 1997, Mrs. Bryant took her prescribed Betapace in the morning and at noon, and took Posicor for the first time at 10:00 a.m.
- Later that afternoon, Clyde C. Bryant found his wife at the bottom of the stairs in their home.
- It was later determined that Carolyn Bryant had suffered severe brain injuries, which her husband alleged were caused by the interaction of Posicor and Betapace.
Procedural Posture:
- Clyde C. Bryant, on behalf of his wife's estate and himself, filed suit against Hoffmann-La Roche, Inc. in a Georgia trial court.
- The lawsuit asserted claims of strict liability, negligence, breach of warranty, and loss of consortium.
- Hoffmann-La Roche filed motions in limine to exclude the testimony of Bryant's expert witnesses, which the trial court granted.
- Hoffmann-La Roche moved for summary judgment on all claims.
- The trial court granted summary judgment in favor of Hoffmann-La Roche.
- Bryant (appellant) appealed the grant of summary judgment and the exclusion of his expert witnesses to the Georgia Court of Appeals, an intermediate appellate court.
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Issue:
Under Georgia law, are pharmaceutical manufacturers subject to strict liability for design defect claims, or are such claims barred by Comment k of the Restatement (Second) of Torts § 402A?
Opinions:
Majority - Adams, J.
Yes, pharmaceutical manufacturers are subject to strict liability for design defect claims, as Comment k is an affirmative defense, not a bar to liability. This court holds that claims for design defects in prescription drugs are to be evaluated under Georgia's established risk-utility analysis. The court explicitly rejects both the minority rule granting blanket immunity to drug manufacturers and the more stringent standard proposed in the Restatement (Third) of Torts § 6(c). Instead, it aligns with the majority of jurisdictions that treat Comment k as an affirmative defense, placing the burden on the manufacturer to prove that the product's benefits outweigh its risks, that it contained adequate warnings, and that it could not have been made safer. The court also held that the plaintiff's state law tort claims were not preempted by federal law because they arose from duties under state common law, not from alleged fraud on the FDA. Finally, the court found that Bryant's expert testimony was largely admissible and that genuine issues of material fact precluded summary judgment on the design defect and failure-to-warn claims.
Concurring - Andrews, P.J.
Yes, but for different reasons; a different legal standard should apply specifically to prescription drugs. While I agree with the majority's conclusion to reverse summary judgment, I disagree with applying the general risk-utility test from Banks. Prescription drugs are unique due to the extensive FDA approval process and their distribution through learned intermediaries (physicians). I would adopt the standard from the Restatement (Third) of Torts § 6(c), which states a drug is defectively designed only if its foreseeable risks are so great compared to its benefits that no reasonable healthcare provider would prescribe it for any class of patients. This test properly accounts for the realities of drug development and regulation, unlike the general risk-utility test which is unworkable for pharmaceuticals. Therefore, I would remand the case for the parties to proceed under this more appropriate, specific standard.
Analysis:
This case is a matter of first impression in Georgia, establishing the standard for strict liability design defect claims against pharmaceutical manufacturers. By adopting the majority view that Comment k is an affirmative defense and applying the existing risk-utility framework, the court rejected calls for special protection for the pharmaceutical industry. This decision solidifies that, in Georgia, prescription drugs will be treated similarly to other products in design defect litigation, placing the burden on manufacturers to justify a drug's risks relative to its benefits. The rejection of the Restatement (Third) § 6(c) standard signals a reluctance to adopt newer, more manufacturer-friendly tort principles, ensuring a more plaintiff-friendly path for such claims compared to what the concurrence proposed.
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