On this page
Drug Injuries: Key Facts Ways Around the Texas Presumption Brand-Name vs. Generic Drugs Drug Injury Lawyers Across Texas Frequently Asked QuestionsTHE LAW GIANT product liability lawyers:
We Fight for Your Rights
A drug injury claim in Texas starts with one question: were the warnings approved by the FDA? If so, the law presumes they were adequate, and the claim must fit one of a few narrow exceptions.
Call The Law Giant at 956-982-1800 or contact us online for a free consultation. You pay nothing unless we win.
Drug Injuries: Key Facts
- The FDA received about 1.31 million drug adverse event reports in 2025. 97,722 of them listed a death, though a report alone does not prove a drug caused the harm, according to openFDA.
- Texas presumes FDA-approved drug warnings are adequate. A patient can rebut that presumption only in specific situations, under CPRC § 82.007.
- The Fifth Circuit held that the “fraud on the FDA” exception is preempted unless the FDA itself found fraud. That 2012 ruling is No. 10-10956.
- Texas’s share of opioid settlements has reached $3.358 billion. The money goes to state and local governments, according to the Texas Attorney General.
Ways Around the Texas Presumption
Under § 82.007(b), a patient can overcome the presumption by showing, for example, that the defendant:
- Kept selling the drug after the FDA ordered it off the market or withdrew approval.
- Promoted the drug for an unapproved use, and the injury came from that use.
- Prescribed the drug for an unapproved use, and the injury came from that use.
- Engaged in bribery that made the approved warnings inadequate.
Claims that do not depend on the warning, such as a manufacturing defect or contamination, are not covered by this presumption.
Brand-Name vs. Generic Drugs
Brand-name makers control their labels and can strengthen warnings, so failure-to-warn claims against them are generally allowed, the U.S. Supreme Court held in Wyeth v. Levine (2009).
Generic makers must copy the brand label, so warning-based claims against them are usually preempted, under PLIVA v. Mensing (2011). Knowing which version you took matters from day one.
Drug Injury Lawyers Across Texas
See our dangerous drug pages for Houston, Dallas, Austin, San Antonio, McAllen, Laredo, Harlingen and Brownsville. For implants and devices, see our defective medical device page.
Call 956-982-1800. You pay nothing unless we win.
Common Questions
Texas Dangerous Drug FAQs
Can I sue a drug company if the FDA approved the drug?
Sometimes. Texas presumes FDA-approved warnings are adequate, but the presumption can be rebutted in specific situations.
Can I sue if I took a generic drug?
Warning-based claims against generic makers are usually preempted, but other claims, such as manufacturing defects, may remain.
Do FDA adverse event reports prove my case?
No. They are reports, not proof that a drug caused harm, but they can help show what the maker knew.
What should I keep after a drug injury?
The pill bottle or packaging, pharmacy receipts, the prescription label and your medical records.
How long do I have to file?
Generally two years from when the injury was or should have been discovered. Some deadlines are shorter, so act quickly.
Giant Wins for All Injuries
Our personal injury lawyers handle a wide range of accidents and serious injuries across Texas.
The Law Giant Stands With You
More About The Law Giant →
4.9