Texas has a law that gives pharmaceutical companies a “rebuttable presumption” of non-liability. In simple terms, this means that if the U.S. Food and Drug Administration (FDA) approves a drug’s warning label, the court will assume that the warning was adequate. This presumption isn’t just for the drug manufacturers. It also protects health care providers who prescribe the medication, pharmacies that distribute the drug and other parties involved in getting the drug to patients.
This can make the legal process potentially more challenging, especially if a person’s injury was a result of inadequate warnings or information. However, it’s important to note that the presumption is “rebuttable.” This means there are ways to challenge these FDA-approved warnings.
Withholding or misrepresenting information
Pharmaceutical companies must provide all relevant data about a drug’s safety and effectiveness during the FDA drug approval process. If evidence suggests that a company didn’t disclose important information or provided misleading data, this could be grounds for challenging the presumption. For example, a company knew about a serious side effect from clinical trials but didn’t include this in their FDA submission.
Selling after FDA withdrawal
In some cases, the FDA may order a company to take a medication off the market due to safety concerns. If they continue to sell the drug after such an order, the product could lose the protection provided by the presumption. This situation usually comes up if new evidence about a drug’s risks comes to light after it’s been on the market for some time, leading to an FDA withdrawal order.
Promotion for unapproved uses
The FDA approves drugs for specific medical conditions or “indications.” While doctors can prescribe drugs for other uses, known as “off-label” use, companies cannot promote their drugs for these unapproved uses. If evidence shows that a company marketed their drug for conditions not approved by the FDA, and this led to patient harm, it could be a basis for challenging the presumption.
Your health is important
Your health and well-being are paramount, and it can be distressing when something that should heal you causes unexpected harm. Cases involving FDA-approved medications can be complicated, so it may be wise to consult with an attorney.
