Presto v. Sandoz Pharmaceuticals Corp.
97 Fulton County D. Rep. 1944, 226 Ga. App. 547, 487 S.E.2d 70 (1997)
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Rule of Law:
Under the learned intermediary doctrine, a prescription drug manufacturer's duty to warn of a medication's dangers is discharged by providing an adequate warning to the prescribing physician, not by warning the patient directly.
Facts:
- Greg Presto was being treated for a mental illness with Clozaril, a prescription anti-psychotic drug manufactured by Sandoz Pharmaceuticals Corporation.
- The drug's packaging included a warning recommending that patients be gradually weaned off the drug over a one- or two-week period.
- The warning also stated that if a patient must be abruptly taken off the drug, they should be carefully observed for the recurrence of psychotic symptoms.
- Dr. Warren prescribed Clozaril to Greg.
- In August 1991, due to undesirable side effects, Greg and his mother requested that Dr. Warren take him off the medication, and Dr. Warren agreed.
- Neither Greg nor his parents were informed of the dangers associated with the abrupt discontinuation of Clozaril.
- In September 1991, after stopping the medication, Greg Presto committed suicide.
Procedural Posture:
- Charles and Mary Presto (plaintiffs) filed a lawsuit against Sandoz Pharmaceuticals Corp. and Caremark, Inc. (defendants) in a Georgia trial court.
- Sandoz filed a motion to dismiss for failure to state a claim, which the trial court treated as a motion for summary judgment.
- The trial court granted Sandoz's motion, holding it had no duty to warn the patient directly.
- The trial court also granted summary judgment to Caremark on the plaintiffs' tort and warranty claims.
- The Prestos (appellants) appealed the trial court's grants of summary judgment to the Court of Appeals of Georgia.
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Issue:
Does a prescription drug manufacturer have a legal duty to warn a patient directly of the dangers associated with its medication, or is this duty fulfilled by adequately warning the prescribing physician?
Opinions:
Majority - Blackburn, J.
No. A prescription drug manufacturer's legal duty to warn is fulfilled by providing adequate warnings to the prescribing physician, who acts as a 'learned intermediary.' The court reasoned that Georgia law recognizes the learned intermediary rule, which serves as an exception to the general rule that manufacturers must warn ultimate consumers. This exception exists because prescription drugs are complex, and the prescribing physician is a medical expert capable of weighing the drug's benefits against its potential dangers for a particular patient. The plaintiffs did not claim that the warning provided to Dr. Warren was inadequate. The court also rejected the argument that Sandoz assumed a broader duty by distributing a patient pamphlet, as the pamphlet was not comprehensive, did not purport to list all dangers, and explicitly directed patients to consult their physician with further questions, making any reliance on it for a complete warning unreasonable as a matter of law.
Analysis:
This case strongly affirms the learned intermediary doctrine in Georgia, shielding prescription drug manufacturers from direct-to-consumer failure-to-warn claims so long as the physician is adequately warned. The decision clarifies that providing supplemental, general information to a patient does not, by itself, create a new duty for the manufacturer to provide comprehensive warnings directly to the patient. This precedent reinforces the physician's central role and legal responsibility in communicating drug risks, placing the onus of patient counseling on the medical professional rather than the drug maker. It also limits the applicability of general product liability principles in the specific context of prescription pharmaceuticals.
