Edwards v. Basel Pharmaceuticals case brief
933 P.2d 298 (Okla. 1997)
The court examined a certified question from the United States Court of Appeals for the Tenth Circuit, which presented the question of what determined the scope or extent of the prescription drug manufacturer's duty to warn the consumer when FDA recognition of the need for direct warnings had undercut application of the learned intermediary rule.
OVERVIEW: The decedent died of a nicotine-induced heart attack as a result of smoking cigarettes while wearing two nicotine patches that were produced by defendant manufacturer. Plaintiff widow claimed that her husband's death was due to his use of a prescribed pharmaceutical product and that defendant failed to adequately warn plaintiff's husband of the effects of overdose. While the case was pending in a federal court, the court was asked to examine the certified question of what was the effect of the manufacturer's compliance with FDA requirements invoking the "learned intermediary rule," which allegedly barred liability because the prescribing physicians were given complete warnings.
HOLDING:
The court held that the compliance with the FDA warning requirements did not necessarily satisfy the manufacturer's common law duty to warn the consumer.
ANALYSIS:
-The FDA found a need to require that prescriptions for nicotine patches be accompanied by warnings to the ultimate consumer as well as to the physician.
-Finally, the court found that defendant had knowledge of the dangers of the patch and that defendant had the duty to warn of foreseeable and known dangers, but not obvious dangers.
RULE:
-When the FDA requires warnings be given directly to the patient with a prescribed drug, an exception to the "learned intermediary doctrine" has occurred, and the manufacturer is not automatically shielded from liability by properly warning the prescribing physician.
-When this happens the manufacturer's duty to warn the consumer is not necessarily satisfied by compliance with FDA minimum warning requirements.
-The required warnings must not be misleading, and must be adequate to explain to the user the possible dangers associated with the product.
-Whether that duty has been satisfied is governed by the common law of the state, not the regulations of the FDA, and necessarily implicates a fact-finding process.
OUTCOME: The court answered the certified question and held that when the FDA required warnings be given directly to the patient with a prescribed drug, an exception to the "learned intermediary doctrine" occurred, and the manufacturer was not automatically shielded from liability by properly warning the prescribing physician.
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933 P.2d 298 (Okla. 1997)
The court examined a certified question from the United States Court of Appeals for the Tenth Circuit, which presented the question of what determined the scope or extent of the prescription drug manufacturer's duty to warn the consumer when FDA recognition of the need for direct warnings had undercut application of the learned intermediary rule.
OVERVIEW: The decedent died of a nicotine-induced heart attack as a result of smoking cigarettes while wearing two nicotine patches that were produced by defendant manufacturer. Plaintiff widow claimed that her husband's death was due to his use of a prescribed pharmaceutical product and that defendant failed to adequately warn plaintiff's husband of the effects of overdose. While the case was pending in a federal court, the court was asked to examine the certified question of what was the effect of the manufacturer's compliance with FDA requirements invoking the "learned intermediary rule," which allegedly barred liability because the prescribing physicians were given complete warnings.
HOLDING:
The court held that the compliance with the FDA warning requirements did not necessarily satisfy the manufacturer's common law duty to warn the consumer.
ANALYSIS:
-The FDA found a need to require that prescriptions for nicotine patches be accompanied by warnings to the ultimate consumer as well as to the physician.
-Finally, the court found that defendant had knowledge of the dangers of the patch and that defendant had the duty to warn of foreseeable and known dangers, but not obvious dangers.
RULE:
-When the FDA requires warnings be given directly to the patient with a prescribed drug, an exception to the "learned intermediary doctrine" has occurred, and the manufacturer is not automatically shielded from liability by properly warning the prescribing physician.
-When this happens the manufacturer's duty to warn the consumer is not necessarily satisfied by compliance with FDA minimum warning requirements.
-The required warnings must not be misleading, and must be adequate to explain to the user the possible dangers associated with the product.
-Whether that duty has been satisfied is governed by the common law of the state, not the regulations of the FDA, and necessarily implicates a fact-finding process.
OUTCOME: The court answered the certified question and held that when the FDA required warnings be given directly to the patient with a prescribed drug, an exception to the "learned intermediary doctrine" occurred, and the manufacturer was not automatically shielded from liability by properly warning the prescribing physician.
---
Interested in learning how to get the top grades in your law school classes? Want to learn how to study smarter than your competition? Interested in transferring to a high ranked school?
-->
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