Centocor v. Hamilton

Supreme Court of Texas · 2012 · Torts

Tortsproducts liabilityfailure to warnprescription drugsprescription drug manufacturerduty to warnphysician-patient relationshipdirect-to-consumer advertising

Facts

Patricia Hamilton was prescribed Remicade by her physicians to treat Crohn’s disease and later joint pain. Centocor’s FDA-approved package insert given to the prescribing doctors warned that Remicade could rarely cause a lupus-like syndrome, and it was undisputed that Patricia’s doctors were aware of that risk when they prescribed and treated her with the drug. During an infusion administered by non-prescribing physician Dr. Bullen, Patricia watched a Centocor informational video that did not mention lupus-like syndrome, and the Hamiltons claimed the video bypassed the physician-patient relationship and created a duty to warn Patricia directly. Patricia later developed symptoms consistent with lupus-like syndrome, but the record contained no evidence that any different warning would have changed her prescribing physicians’ decisions to prescribe Remicade.

Issue

Whether the learned intermediary doctrine applies to Patricia Hamilton’s claims against a prescription drug manufacturer within an existing physician-patient relationship, including claims framed as fraud and other common-law theories, and whether a direct-to-consumer advertising exception applies on these facts. Also, whether the Hamiltons produced evidence that any allegedly inadequate warning caused Patricia’s injuries.

Rule

Within the physician-patient relationship, a prescription drug manufacturer fulfills its duty to warn end users by providing an adequate warning to the prescribing physician, who acts as the learned intermediary. The doctrine is a common-law rule, not an affirmative defense, and it applies to all claims whose gravamen is failure to warn, including fraud-by-omission claims based on omitted side-effect information. If the warning to the prescribing physician is inadequate or misleading, the plaintiff must still prove that the inadequate warning was a producing cause of the injury by showing it would have changed the prescribing decision; no direct-to-consumer advertising exception applies on the facts presented here.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

In Austin, gastroenterologist Dr. Elena Ruiz prescribed a biologic drug manufactured by Blue Mesa Therapeutics to Jordan Pike for a severe autoimmune condition. The FDA-approved package insert given to Dr. Ruiz warned that the drug could rarely cause nerve inflammation, and Jordan later developed that complication after taking the drug.

If Jordan sues Blue Mesa for failure to warn him directly, which result is most consistent with the governing rule?

Explanation. Within a physician-patient relationship, a prescription drug manufacturer generally fulfills its duty to warn end users by adequately warning the prescribing physician, who serves as the learned intermediary. The manufacturer does not ordinarily owe a separate direct-warning duty to the patient.