# FDA approval does not prevent lawsuits

> Why FDA approval of a drug does not shield manufacturers from product liability claims.

**Canonical URL:** https://drugsmonitor.com/guides/fda-approval-process-vs-litigation
**Last updated:** 2026-06-11

Many people assume that if the FDA approved a drug, it must be safe and manufacturers cannot be sued. In reality, FDA approval sets a minimum safety standard, and state law product liability claims can proceed even after FDA review.

Plaintiffs can allege that manufacturers failed to adequately warn about risks they knew or should have known, designed the product defectively, or misrepresented safety data. FDA approval does not preempt most state law claims.

The PLIVA v. Mensing case limited failure-to-warn claims for generic drugs, but brand-name manufacturers can still be held liable. An attorney can explain which theories apply to your specific situation.

---

*Educational guide from DrugsMonitor.com. Not legal advice.*