William A. Ruskin: Texas Adopts Learned Intermediary Doctrine

By William A. Ruskin

The Texas Supreme Court rendered judgment in favor of Centocor, Inc., the pharmaceutical manufacturer subsidiary of Johnson & Johnson, in a landmark decision involving the learned intermediary doctrine, Centocor, Inc. v. Patricia Hamilton, Thomas Hamilton and Michael G. Bullen, M.D. (No. 10-0223). [enhanced version available to lexis.com subscribers].  The International Association of Defense Counsel (IADC), which often weighs in on signficant jurisprudential issues before appeals courts, filed an amicus brief requesting that the Court reject the direct-to-consumer advertising exception to the learned intermediary doctrine that had been recognized by the intermediate appellate court. Porter Hedges LLP filed the brief on IADC's behalf.

The decision is significant because it the first time that the Texas Supreme Court has expressly recognized the learned intermediary doctrine. Texas now joins the vast majority of states that have adopted the learned intermediary rule. In a press release issued [June 28], IADC reported that the Court declined to create a direct-to-consumer advertising exception to the learned intermediary rule, despite the fact that two other states had 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 what is, at its core, a failure to warn case. Significantly, the Court also recognized that the learned intermediary rule is not an affirmative defense, but a legal doctrine that is part and parcel 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."

Notably, the Texas Supreme Court was critical of the lower court's opinion, which had attempted to carve out an exception to the learned intermediary doctrine for direct-to-consumer advertising. Although plaintiff Hamilton alleged various common law causes of action, all of her claims pivoted on the issue of whether the Centocor had provided an adequate warning to her physician in its prescribing information. Therefore, the Court ruled, the learned intermediary doctrine applied to all of Hamilton's claims. It was incumbent upon plaintiff to demonstrate that an inadequate warning to her prescribing physician was responsible for her injury. Because plaintiff failed to present any evidence that the purportedly inadequate warning was at the root of the physician's decision to prescribe the medication, her claims failed as a matter of law."

For more cutting edge commentary on developing issues, visit Toxic Tort Litigation Blog by William A. Ruskin of Epstein Becker & Green.

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