In a Texas pharmaceutical injury or medical device lawsuit, where the lawsuit centers on a failure to warn, TX Civil Practice and Remedies Code (CPRC) creates a presumption of no liability if the warnings associated with the product were not approved by the Food and Drug Administration (FDA) .
There are several ways a Texas medical device injury lawyer can overcome the presumption of no liability, First, he can show that the manufacturer deceived the FDA by omitting or distorting required information needed for pre-market government endorsement and licensing. Any deception in the withholding or distortion of information must be material to the Texas serious personal injury claim and the element of causation is present.
Another way to overcome the presumption of no liability is to demonstrate continued sale of the drug or medical device after the FDA mandated market removal or no longer endorsed the product.