1. Suing the Federal Government

2. History Traditional Sovereign Immunity US Constitution "No Money shall be drawn from the Treasury, but in Consequence of Appropriations made by Law." U.S. Const. art. I, § 9. All compensation had to be by private bills What problems do private bills pose?

3. Court of Claims 1855 Administrative tribunal to review claims and make recommendations to Congress Later Congress made the decisions binding Not an Art II court Like bankruptcy courts Appeal to the Federal circuit and the United States Supreme Court Contracts, tax refunds, takings - not torts

4. Federal Tort Claims Act Went into effect in 1945 All private bills before then Allowed tort claims Significant exceptions http://biotech.law.lsu.edu/cases/immunity/ftca_ exceptions.htm http://biotech.law.lsu.edu/cases/immunity/ftca_ exceptions.htm

5. Dalehite v. U.S., 346 U.S. 15 (1953) Texas City Disaster http://www.local1259iaff.org/disaster.html Why is the TVA producing ammonium nitrate fertilizer? Why were they producing it during the war? Where is it going? Why might a ship also be carrying explosives?

6. The General Claim The negligence charged was that the United States, without definitive investigation of FGAN properties, shipped or permitted shipment to a congested area without warning of the possibility of explosion under certain conditions. The District Court accepted this theory.

7. Specific Findings by the Trial Court the Government had been careless in drafting and adopting the fertilizer export plan as a whole, specific negligence in various phases of the manufacturing process, and those which emphasized official dereliction of duty in failing to police the shipboard loading.

8. The Statute (a) Any claim based upon an act or omission of an employee of the Government, exercising due care, in the execution of a statute or regulation, whether or not such statute or regulation be valid, or based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the discretion involved be abused.

9. What is the Intent of this Provision? What is a discretionary function? Why do we limit claims based on government decisionmaking? What are the consequences for allowing litigants to challenge government polices? How does this mirror juridical review of rules and adjudications? What is the remedy for bad decisions? What about compensation?

10. The United States Supreme Court Ruling What did the United States Supreme Court rule about the government's actions in this case?

11. Allen v. United States, 816 F.2d 1417 (10th Cir. 1987) - The Clears up the Cloud How did the government put these people at risk? Did the government deny that they caused any injuries? Was this an accident? What did the government intend to do? What is the discretionary authority issue and how was it resolved? What do you do if you do not like this?

12. Berkovitz by Berkovitz v. U.S., 486 U.S. 531 (1988) What was the product in Berkovitz? What did the FDA regulations require? What did the plaintiffs claim the FDA failed to do? What was the FDA’s defense?

13. Polio Vaccine Cases Salk vaccine Dead virus - supposedly Sabin vaccine Live, attenuated vaccine Gives a mild infection Can spread to others - which is good What if someone is immunosuppressed?

14. Cutter Incident During the first wave of vaccinations when the vaccine became available in 1955 Some vaccine was not killed and children became infected Remember, there is still polio in the community at this time First vaccine litigation Real injuries, but a real benefit

15. Post Cutter Incident Undermined confidence in vaccines 402 A made vaccine cases easier to prove There was some natural spread from Sabin virus Swine Flu vaccine came along in 1975 and might have caused a neurologic disease

16. Swine Flu 1974-75 flu season New strain of flu that was thought to resemble the 1918-1919 Spanish Influenza Feds did a massive vaccine campaign Companies demanded immunity for lawsuits Congress let plaintiffs substitute the feds as plaintiff, and allowed strict liability theories

17. Swine Flu - Legal Consequences Huge incentive to find injuries Diagnosis of Guillain-Barre syndrome was ambiguous No lab test vague finding in all but the extreme cases Docs were encouraged to make the diagnosis Maybe the first big injury case where plaintiff's attorneys shaped the epidemiology and perception of the disease Berkovitz happened in this climate - 1979

18. Varig Airlines (in Berkovitz) What was the injury in Varig Airlines? What did the enabling act require the agency to do? What did the regs require? How are the regs in Berkovitz different from those in Varig Airlines?

19. Agency Liability Why was the FDA liable in Berkovitz? How could the FDA have worded the regulations to avoid this sort of liability? Why might that have raised a red flag during notice and comment?

20. Bird Flu What are the legal issues? How can the feds deal with these? What about rolling an experimental vaccine? What if the feds make you take the experimental vaccine? What does Jacobson tell us? And it harms you? What does Allen tell us?

21. Leleux v. United States, 178 F.3d 750 (5th Cir. 1999) What are the facts? What disease did she claim she caught? Did she consent to the sex? Why is that critical to an FTCA claim? Did she consent to the disease? Why does that cause problems with the FTCA?

22. Can the Government Be Liable When the Case Involves Battery? Sheridan v. United States, 487 U.S. 392 (1988) Government assumed a duty to restrain a an intoxicated, armed serviceman Government did not carry out this duty properly Did the case depend on the serviceman being a government employee? What if he had been a civilian?

23. Contrast Leleux with Sheridan If the recruiter were not a government employee, would plaintiff have case against the government? How does this differ from Sheridan?