The Learned Intermediary Doctrine Applies to Prescription Drug Products-Liability Cases

Prescription Medicine

The Texas Supreme Court recently held that a prescription drug manufacturer fulfills its duty to warn users of its product’s risks by providing warnings to the intermediaries who prescribe the drug. Once a manufacturer warns intermediaries, it has no further duty to warn the end users directly.

In Centocor, Inc. v. Hamilton, No. 10-0223, 2012 WL 2052783 (Tex. 2012), a patient, Patricia Hamilton (“Hamilton”) developed a side effect from treatments with a drug manufactured by Centocor, Inc. (“Centocor”), a subsidiary of Johnson & Johnson and a prescription drug manufacturer.  Centocor marketed directly to Hamilton. Hamilton brought an action against Centocor, alleging failure to warn, fraud, and negligence. Centocor argued that the learned intermediary doctrine applied and it had no duty to warn Hamilton directly of the risks and potential side effects associated with the drug.

This is the first time the Texas Supreme Court has considered a case that presents the applicability of the learned intermediary doctrine within the context of prescription drug products-liability cases. The Texas Supreme Court held that “because patients can obtain prescription drugs only through their prescribing physician or another authorized intermediary and because the earnedintermediary’ is best suited to weigh the patient’s individual needs in conjunction with the risks and benefits of the prescription drug,” the learned intermediary doctrine applies and limits the drug manufacturer’s duty to warn only the prescribing physician. The Texas Supreme Court further held that the learned intermediary doctrine is not a common-law affirmative defense, which would shift the burden on drug manufacturers to “plead, prove and request jury findings” on the doctrine. Rather, the Texas Supreme Court held that it is “more akin to a common-law rule.” The Texas Supreme Court held that Hamilton had the burden to prove that Centocor’s warning to the prescribing doctors was inadequate.