Centocor, Inc. v. Hamilton
372 S.W.3d 140 (2012)
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Rule of Law:
Under the learned intermediary doctrine, a prescription drug manufacturer satisfies its duty to warn end users of its product's risks by providing an adequate warning to the prescribing physician. The manufacturer is not liable for a patient's injuries if the prescribing physician was aware of the risks, as any inadequacy in the manufacturer's warning is not the producing cause of the injury.
Facts:
- Patricia Hamilton, who had a long history of Crohn's disease, suffered a flare-up in 2001.
- Her gastroenterologist, Dr. Ronald Hauptman, discussed treatment options with her, and they decided she would take the prescription drug Remicade, manufactured by Centocor.
- Dr. Hauptman referred Hamilton to an infusion clinic operated by Dr. Michael Bullen to administer the Remicade intravenously.
- During Hamilton's first infusion, a nurse at Dr. Bullen's clinic showed her an informational video produced by Centocor; the video did not mention lupus-like syndrome as a potential side effect.
- After initial treatments, Hamilton developed severe joint pain and was referred to rheumatologist Dr. Adriana Pop-Moody, who prescribed fourteen additional Remicade infusions between April 2002 and September 2003.
- Hamilton's prescribing physicians, Dr. Hauptman and Dr. Pop-Moody, were both aware that Remicade carried a risk of causing lupus-like syndrome.
- In September 2003, Hamilton was diagnosed with a condition consistent with drug-induced lupus-like syndrome.
- Her symptoms subsided after she discontinued Remicade treatments.
Procedural Posture:
- Patricia and Thomas Hamilton sued Centocor, Inc. in state trial court.
- The Hamiltons later amended their petition to add Patricia's prescribing physicians, Dr. Hauptman and Dr. Pop-Moody, and her treating physician, Dr. Bullen, as defendants.
- At trial, the court granted a directed verdict in favor of Dr. Bullen, the non-prescribing, treating physician.
- A jury found Centocor liable for fraud, misrepresentation, and negligence, awarding the Hamiltons over $1.2 million in actual damages and $16 million in exemplary damages.
- Dr. Hauptman and Dr. Pop-Moody settled with the Hamiltons before the trial court entered final judgment.
- The trial court entered judgment against Centocor for a total of approximately $4.8 million after applying settlement credits and statutory caps.
- Centocor, as appellant, appealed to the Texas Court of Appeals, and the Hamiltons were the appellees.
- The Court of Appeals affirmed most of the trial court's judgment, creating a direct-to-consumer advertising exception to the learned intermediary doctrine, but reversed the award for future pain and mental anguish.
- Centocor petitioned the Supreme Court of Texas for review.
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Issue:
Does the learned intermediary doctrine shield a prescription drug manufacturer from liability for failure to warn a patient directly of a drug's potential risks, even when the manufacturer provides informational materials to the patient through a treating physician, if the prescribing physician was already aware of those risks?
Opinions:
Majority - Justice Green
Yes. The learned intermediary doctrine applies, limiting a prescription drug manufacturer's duty to warn to the prescribing physician rather than the end user. The court's reasoning is threefold. First, it formally adopts the learned intermediary doctrine for prescription drug cases in Texas, reasoning that the prescribing physician is in the best position to weigh the complex risks and benefits for a specific patient. Second, the court rejects creating a direct-to-consumer (DTC) advertising exception on these facts, as the informational video was shown after the decision to prescribe Remicade had already been made and the first infusion had begun, meaning it did not influence the decision. The court concludes that all of the Hamiltons' claims, including fraud and negligence, were substantively failure-to-warn claims to which the doctrine applies. Finally, and dispositively, the Hamiltons failed to prove causation. It was undisputed that Hamilton's prescribing physicians were aware of the risk of lupus-like syndrome when they prescribed Remicade. The plaintiffs presented no evidence that a different or stronger warning from Centocor would have changed the physicians' decision to prescribe the drug, meaning any inadequacy in the warning was not the producing cause of Patricia Hamilton's injury.
Analysis:
This decision solidifies the learned intermediary doctrine as the controlling rule for prescription drug liability in Texas, reinforcing the physician as the central figure in communicating drug risks to patients. The court's refusal to create a direct-to-consumer advertising exception on these facts sets a high bar for future plaintiffs, requiring them to show that such advertising directly influenced the prescribing decision. The ruling also clarifies that plaintiffs cannot circumvent the doctrine by recasting failure-to-warn claims as fraud or negligence. The emphasis on causation—requiring proof that a different warning would have altered the physician's conduct—makes it significantly more difficult for plaintiffs to succeed in cases where the prescribing doctor was already aware of the relevant risk.
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