If you've been sickened or a loved one has been killed by a defective medication, you're probably thinking about filing a defective drugs lawsuit against the pharmaceutical manufacturer. But you may be wondering if you can also sue the U.S. Food & Drug Administration for approving the drug in the first place.
Under a legal concept known as "sovereign immunity" you cannot sue the FDA for approving a drug that is later proven to be defective and dangerous.
Sovereign immunity says:
The federal government-which would include the FDA-has waived its immunity in two limited circumstances:
You might be thinking to yourself, "An FDA employee did something wrong by approving Yaz or pelvic mesh or Pradaxa or another defective drug," so I should be allowed to sue the agency under the Federal Torts Claims Act." However, there are a number of exceptions written into the Act, and one of them bars lawsuits against the FDA in conjunction with its responsibilities for licensing and approving drugs and vaccines. As a result, you cannot sue the FDA for approving a defective drug.