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Texas Supreme Court Rules that a Manufacturer Satisfies its Duty to Warn by Providing Sufficient Warning to a Doctor: Centocor, Inc. v. Hamilton

woman in hospital.jpgOne key product liability issue to watch for in 2013 is reportedly the continued adoption of the learned intermediary doctrine by states. In June 2012, Texas joined 35 other states in holding that a sufficient warning to a treating doctor (the “learned intermediary”) satisfies a manufacturer’s duty to warn in product liability cases involving medicine and medical devices. Adoption of this rule essentially means that pharmaceutical manufacturers are not responsible for conveying drug risks to patients, even when the drug makers advertise their products directly to consumers.

With the Texas Supreme Court’s decision in Centocor, Inc. v. Hamilton, Texas became the largest remaining state where the Supreme Court had not adopted the learned intermediary rule, which requires warnings only to prescribing physicians–not to any health care provider with which the plaintiff may happen to come into contact. Unfortunately for future victims of negligent misbranding, negligent marketing, and fraud in drug/medical device product liability cases, the court all but did away with the direct-to-consumer exception to the rule, making it more difficult for plaintiffs to successfully bring suit against drug manufacturers.

In Centocor, Inc. v. Hamilton, the product at issue was Remicade, a prescription drug manufactured by Centocor, Inc. Patricia Hamilton suffered from Crohn’s disease and sought treatment from her physician, who informed her that her only treatment options were steroids or Remicade intravenous infusions. After her physician informed her of the risks and benefits of each approach, Patricia opted for the Remicade infusions. Following the treatment, Patricia claimed that the Remicade infusions caused her to suffer a serious drug-induced side effect called lupus-like syndrome.

Patricia and Thomas Hamilton brought suit, contending that the informational video shown to Hamilton by her physician in the course of her prescribed treatments provided “inadequate and inappropriate warnings and instruction for use” of its prescription drug Remicade, which made Remicade “defective and unreasonably dangerous.” More specifically, the couple alleged that Centocor’s video over-emphasized the benefits of Remicade and intentionally omitted warnings about the potential side effect of lupus-like syndrome. They argued that the video bypassed the physician-patient relationship and required Centocor to warn Patricia directly of Remicade’s potential risks and side effects, thereby making Centocor liable for Patricia’s injuries.


Overturning the court of appeals, the Texas Supreme Court held that the learned intermediary rule generally applies with 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. The court further held that court of appeals erred by creating the direct-to-consumer (DTC) advertising exception to the learned intermediary doctrine, an exception which that finds drug makers may be held liable when they directly advertise to consumers in a “fraudulent manner. The court ruled that information designed for patient consumption does not trump to learned intermediary rule, rendering the DTC exception all but obsolete except in cases of intentional and deliberate falsehood by manufacturers. Finally, the court held that held that the learned intermediary rule is not an affirmative defense. As such, the plaintiff retains all relevant burdens of proof.

If you or a loved one are suffering side effects from a prescription drug that you were not adequately warned about, you should discuss your case with a knowledgeable pharmaceutical injury attorney. Call Carabin & Shaw toll free at (800) 862-1260. At Carabin & Shaw, our dedicated San Antonio pharmaceutical injury lawyers assist clients who were hurt by a drug maker’s product throughout Texas receive the compensation they deserve. Our hardworking attorneys are available to help Texans who were injured through no fault of their own in McAllen, Laredo, Beaumont, Beeville, Rockport, El Paso, San Antonio, Seguin, and Austin. To schedule a free initial consultation with a committed personal injury lawyer today, do not hesitate to contact Carabin & Shaw through the law firm’s website.

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