Compliance with FDA Requirements in a Texas Medical Device Lawsuit

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.

Another way to overcome the presumption of no liability is to demonstrate “off label” use. An off label use occurs when doctors and drug companies begin using a pharmaceutical to treat a problem for which it did not originally receive government approval. If in fact, there was off label use, the presumption of no liability disappears. There are elements of proof associated with off label use. The injured plaintiff must prove that the healthcare provider and / or drug company promoted, advertised, or prescribed the off label use; the injured party used the product as it had been recommended, promoted, advertised, or prescribed; and there was a causal connection between the injury and the recommendations, promotion, advertisement, or prescription of the product.

Another way to overcome the presumption of no liability given compliance with the FDA requirements is that the defendant, either before or after pre-market government approval / licensing, bribed a public official in violation of 18 U.S.C. Section 201 and such conduct precipitated FDA warnings of the product to be substandard.

There has been some controversy over whether a State District Court judge can determine if material information was withheld from the FDA so that plaintiffs can overcome the presumption of no liability. One district court judge granted summary judgment in a Texas Vioxx case on the basis that the FDA is the only entity that can make a determination about whether a manufacturer was deceptive in the warnings information it provided. There have been several follow up cases which have criticized the decision.