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FDA Approval of Warnings May Affect Pharmaceutical Liability


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Previous posts here have discussed the federal Food and Drug Administration in a few different contexts. This agency is responsible for the approval of the use and marketing of pharmaceutical products in Texas and the rest of the United States, and much of its activity may be relevant to people who have been victims of negligence on the part of a prescribing physician or drug manufacturer. Because the FDA is involved with many aspects of the process of bringing medicines to market, it is often the subject of disputes between plaintiffs and defendants.

Failure to Warn of Side Effects

As we have previously touched on, one way that pharmaceutical liability can be established is in the failure of a company or medical professional to adequately warn a patient about the potential effects a drug may have. However, in Texas, potential defendants may be protected from liability in some cases under a certain state statute. Section 82.007 of the Texas Civil Practice and Remedies Code presumes a defendant in a pharmaceutical liability case is not at fault for failure to warn if the warnings distributed with the product were those approved by the FDA for the product.

Off-Label Use for Medications

However, as with many legal presumptions, this one may be rebutted by a plaintiff if it can be shown that the drug manufacturer withheld relevant information from the FDA in the approval process and this information withholding was causally related to the plaintiff’s injuries. Also, the presumption will not apply if the drug was sold after it had been recalled by the FDA, or if the medicine was given to the patient for “off-label” use, one for which the product was not approved by the FDA.

The actions of the FDA can play a large role in the process of a pharmaceutical liability case. Further, when these types of presumptions apply and when they can be rebutted are both often subject to complex interpretations in case law. Texans who believe they have been injured by a pharmaceutical product may want to get more information about their legal options.

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