I am very interested in the idea of filing a law suit against the FDA (although I doubt that I would live long enough to collect anything if we did win). Please be sure to post your thoughts about how to initiate a suit.
You can't sue the FDA, you're tilting at windmills.
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.
P.S. If you're thinking that the second bullet about contracts applies to SPAs, you're wrong - they are not legally binding contracts in that sense, and only AMRN would have standing to sue in any case.
P.P.S. If you google "sue the FDA", you'll find plenty of lawsuites about groups suing them over labeling matters, but again that does not apply here - Sovereign Immunity covers the FDAs butt for everything they did to AMRN.
The Thought Police: To censor and protect. Craig Bruce
