Legal Articles
Defective Drugs
Get Started Finding a Local Attorney Now

Simply fill out this form to connect with an Attorney serving your area.

Can I Sue the FDA for Approving Defective Drugs

Can I Sue the FDA for Approving Defective Drugs

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.

No FDA Defective Drugs Lawsuits

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:

  • Federal, state and tribal governments, as well as foreign governments, are immune from lawsuits.
  • However, a government may be sued if it has waived its immunity or agreed to the lawsuit.

The federal government-which would include the FDA-has waived its immunity in two limited circumstances:

  • Under the Federal Tort Claims Act, the government can be sued if a person acting on behalf of the U.S. government commits a tort, or a civil wrong, and
  • Under the Tucker Act, the U.S. government can be sued if it is party to a contract and the lawsuit relates to the contract

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.