In a recent decision the Texas Supreme Court held for the first time that the learned intermediary doctrine applies within the context of prescription drug products-liability cases. With this decision, Texas joined at least thirty-five states, all of which have adopted or approved some form of the learned intermediary doctrine within the prescription drug products-liability context.
In Centocor, Inc. v. Patricia and Thomas Hamilton, Plaintiffs sued Centocor, Inc., a prescription drug manufacturer and subsidiary of Johnson & Johnson, alleging that it provided inadequate warnings of its prescription drug Remicade. Plaintiffs claimed that the drug caused Mrs. Hamilton to suffer a serious drug-induced side effect called lupus-like syndrome. During Mrs. Hamilton’s treatments with the drug, her doctor showed her an informational video from Centocor, which Plaintiffs alleged intentionally omitted warnings about the potential side effects.
After weeks of trial, the jury found in favor of the Plaintiffs, and the trial court entered judgment for $4.6 million. Although the court of appeals reversed the award of future pain and mental anguish damages, it affirmed the remainder of the trial court’s judgment. In doing so, the court of appeals adopted a direct-to-consumer (DTC) advertising exception to the learned intermediary doctrine. The court of appeals held that Centocor could not rely on its adequate warnings to Mrs. Hamilton’s physicians when it directly misrepresented its product’s side effects. Centocor petitioned to the Supreme Court, arguing that the court of appeals erred by creating an advertising exception to the learned intermediary doctrine.
On appeal, Centocor argued that the learned intermediary doctrine applied and thus, it had no duty to warn Mrs. Hamilton directly of the risks associated with the drug. The Supreme Court explained that generally, a manufacturer is required to provide an adequate warning to the end users of its product if it knows or should know of any potential harm that may result from its use. In some contexts, however, the manufacturer’s duty to warn end users is limited to providing an adequate warning to an intermediary, who then assumes the duty to pass the necessary warnings on to the end users. In reversing the court of appeal’s decision, the Texas Supreme Court held that a prescription drug manufacturer fulfills its duty to warn end users of its product’s risks by providing adequate warnings to the intermediaries who prescribe the drug and once fulfilled, has no further duty to warn the end users directly.
The Supreme Court then addressed the court of appeals application of the DTC exception to the learned intermediary doctrine. The Court emphasized that few courts have applied such an exception, and although the New Jersey Supreme Court adopted a very broad DTC exception, many courts have declined to follow. In fact, West Virginia is the only state whose highest court has followed New Jersey’s view. Rather than ruling on whether Texas law should recognize a DTC advertising exception, the Supreme Court instead held that the exception did not apply based on the specific facts of this case. The Court emphasized that here, the physician-patient relationship existed, the pharmaceutical company provided a warning to the patient’s prescribing doctors, and lastly, Mrs. Hamilton had already visited her doctor and had already decided to take Remicade prior to viewing the informational video. Consequently, the Supreme Court reversed the court of appeal’s ruling, holding that the court of appeals erred in creating a DTC exception based on the specific facts of this case.
This decision was a significant victory for pharmaceutical manufacturers and emphasizes manufacturers’ ability to satisfy their duty to warn in some contexts by providing adequate warnings to physicians, who then assume the duty to pass on the necessary warnings to their patients.
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