Centocor, Inc. v. Hamilton
372 S.W.3d 140
| Tex. | 2012Background
- Patricia Hamilton sued Centocor (Remicade) alleging inadequate warnings and related claims after lupus-like syndrome injuries.
- The court of appeals adopted a direct-to-consumer (DTC) advertising exception to the learned intermediary doctrine, shifting focus to Centocor's marketing directly to Patricia.
- Patricia was treated under a physician–patient relationship; warnings were provided to her doctors via FDA-approved package inserts and an informational video shown at a clinic.
- The 2001 Remicade package insert warned of lupus-like syndrome; post-approval reports suggested more cases, but physicians considered the risk rare.
- Centocor challenged the sufficiency of warnings and causation, arguing the learned intermediary doctrine confines duty to prescribing physicians; the video did not create a direct duty to Patricia.
- The Texas Supreme Court held that the learned intermediary doctrine applies in prescription drug cases, rejects the DTC exception, and requires proof that an inadequate warning to physicians was a producing cause of Patricia’s injuries.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether a DTC advertising exception applies | Hamiltons: Perez-like exception should apply; direct marketing can impose direct liability. | Centocor: no DTC exception; warnings to physicians suffice. | DTC exception does not apply |
| Whether the learned intermediary doctrine applies in prescription drug cases | Hamiltons: doctrine may not apply or may be narrowed by exceptions. | Centocor: doctrine governs duty to warn via physicians. | Doctrine generally applies in physician–patient context |
| Whether the non-prescribing physician owed any duty to warn | Dr. Bullen may owe duty through Centocor materials. | Bullen owed no duty to warn about Remicade beyond infusion risks. | No duty owed by non-prescribing physician |
| Whether the learned intermediary doctrine is a common-law rule or affirmative defense | Treat as an affirmative defense that could bar claims. | Rule or doctrine that governs duties; not a substantive defense. | Doctrine is a common-law rule, not an affirmative defense |
| Whether adequate causation evidence exists that the warning caused injuries | Inadequate warnings produced physicians’ decisions; different warning would have changed outcomes. | No producing cause; physicians were aware risk and would have prescribed anyway. | Hamiltons failed to prove producing cause |
Key Cases Cited
- Gravis v. Parke-Davis & Co., 502 S.W.2d 863 (Tex. App.-Corpus Christi 1973) (recognizes learned intermediary doctrine in prescription drugs)
- Aim v. Aluminum Co. of Am., 717 S.W.2d 590 (Tex. 1986) (intermediary concept; bulk-supplier warning duty)
- Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170 (Tex. 2004) (six-factor Restatement-based analysis for duty to warn)
- Reyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir. 1974) (prescription-drug context and learned intermediary rationale)
- Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87 (Tex.App.-Texarkana 2000) (learned intermediary doctrine not a civil-law defense; applies to all claims)
- Perez v. Wyeth Laboratories Inc., 161 N.J. 1, 734 A.2d 1245 (1999) (DTC advertising exception to learned intermediary doctrine)
- Gravis v. Parke-Davis & Co., 502 S.W.2d 863 (Tex. App.-Corpus Christi 1973) (see above)