## Facts

- Patricia Hamilton had Crohn’s disease and received Remicade (infliximab), a prescription biologic manufactured by Centocor, Inc.
- After infusions, Hamilton developed a serious autoimmune condition described as a “lupus-like syndrome,” which she alleged was caused by Remicade.
- The Hamiltons claimed Centocor’s warnings and instructions were inadequate, making the drug defective and unreasonably dangerous.
- They asserted multiple theories (including failure to warn, negligence, fraud, gross negligence, and malice) and relied in part on a Centocor patient video that allegedly minimized serious risks.
- At trial, the jury returned a verdict for the Hamiltons and awarded substantial compensatory and punitive damages.
- The court of appeals largely affirmed and recognized a direct-to-consumer advertising exception to the learned intermediary doctrine based on manufacturer-to-patient communications.
- Centocor sought review, challenging the exception and arguing the evidence did not show that any inadequate warning caused the physicians’ prescribing decisions.

## Issues

1. Whether Texas recognizes the learned intermediary doctrine for prescription drug warnings.
2. Whether a prescription drug manufacturer satisfies its duty to warn by warning the prescribing physician rather than the patient.
3. Whether Texas should recognize an exception to the learned intermediary doctrine for direct-to-consumer advertising or patient-directed communications.
4. Whether there was evidence that any inadequacy in the manufacturer’s warning was a producing cause of the plaintiff’s injury, given the prescribing physicians’ knowledge and testimony.

## Decision

- The Supreme Court of Texas adopted the learned intermediary doctrine for prescription drug cases.
- The court held the manufacturer generally discharges its duty to warn by providing an adequate warning to the prescribing physician, who then counsels the patient.
- The court rejected a direct-to-consumer advertising exception and held the court of appeals erred in creating one.
- The court treated the plaintiff’s pleaded theories as warning-based claims in substance, so the learned intermediary doctrine governed all claims.
- The court held there was no evidence that any alleged warning inadequacy was a producing cause of the physicians’ decisions to prescribe Remicade.
- The court reversed the relevant portion of the court of appeals’ judgment and rendered a take-nothing judgment for Centocor.

## Legal Principles

- In prescription drug cases, a manufacturer satisfies its duty to warn by adequately warning a learned intermediary, typically the prescribing physician, who evaluates risks and benefits and advises the patient.
- The learned intermediary doctrine operates as part of the plaintiff’s case in warning-based claims; the plaintiff must prove both warning inadequacy to the physician and producing cause.
- Texas does not recognize a general exception to the learned intermediary doctrine based on direct-to-consumer advertising or patient-directed materials.
- A plaintiff cannot avoid the learned intermediary doctrine by relabeling a warning-based theory as fraud, misrepresentation, or other common-law causes of action.
- If the prescribing physician was aware of the relevant risk and would have prescribed the drug anyway, an alleged warning inadequacy is not, as a matter of law, a producing cause of the patient’s injury.

## Conclusion

The Texas Supreme Court adopted the learned intermediary doctrine, rejected a direct-to-consumer advertising exception, and held that without evidence the physicians’ prescribing decisions would have changed with different warnings, the manufacturer is entitled to judgment as a matter of law.


Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012)