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Texas Supreme Court Agrees with the IADC and Reverses and Renders Judgment Against Pharmaceutical Manufacturer in Suit Challenging the Learned Intermediary Doctrine in Centocor, Inc. v. Hamilton

Porter Hedges LLP filed an Amicus Brief on behalf of the IADC in Support of Centocor

Houston, June 8, 2012 – The Texas Supreme Court has reversed and rendered judgment in favor of a pharmaceutical manufacturer in a landmark Texas decision involving the learned intermediary doctrine, Centocor, Inc. v. Patricia Hamilton, Thomas Hamilton and Michael G. Bullen, M.D. (No. 10-0223). Porter Hedges LLP filed an amicus brief on behalf of the International Association of Defense Counsel (IADC) in this case, requesting that the Court reject the direct-to-consumer advertising exception to the learned intermediary doctrine recognized by the Thirteenth Court of Appeals, Corpus Christi, Texas (No. 13-07-00301-CV).

This is the first time that the Texas Supreme Court has expressly recognized the learned intermediary doctrine. Texas now follows the vast majority of states that have adopted the learned intermediary rule. The Court declined to create a direct-to-consumer advertising exception to the learned intermediary rule, despite the fact that two other states have done so. The Court also recognized that a plaintiff cannot plead around the learned intermediary rule by asserting causes of action such as fraud in a failure to warn case. Significantly, the Court also recognized that the learned intermediary rule is not an affirmative defense, but a legal doctrine and a part of the plaintiff’s burden of proof. Further, the Court determined that where a prescribing physician is aware of a drug’s risks, “any inadequacy of the product’s warning, as a matter of law, is not the producing cause of the patient’s injuries.”

In the opinion, the Court indicated that “Under the learned intermediary doctrine, the manufacturer of a pharmaceutical product satisfies its duty to warn the end user of its product’s potential risks by providing an adequate warning to a ‘learned intermediary,’ who then assumes the duty to pass on the necessary warnings to the end user.” The Court held that “the doctrine generally applies within the context of a physician-patient relationship and allows a prescription drug manufacturer to fulfill its duty to warn end users of its product’s potential risks by providing an adequate warning to the prescribing physician.”

It further held that “the court of appeals erred by creating an exception to the learned intermediary doctrine for direct-to-consumer (DTC) advertising. Although the patient alleged various common law causes of action, all of the patient’s claims turn on the prescription drug manufacturer’s failure to warn. Therefore, the learned intermediary doctrine applies to all of the patient’s claims, and the patient was required to show that an inadequate warning to the prescribing physicians caused the patient’s injuries. Because the patient presented no evidence that the allegedly inadequate warning was a producing cause of her physicians’ decisions to prescribe the prescription drug, her claims fail as a matter of law.”

Porter Hedges Litigation partners Lauren Beck Harris and Joseph D. Cohen were the lead counsel on the brief.

To view the additional details on the specific issues in the case or see the full amicus brief, click here.

To view the full opinion, click here.

For additional information, click the article link below.

"Court Nixes Jury Verdict, Applies Learned Intermediary Doctrine," Texas Lawyer (06/18/12)

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