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?
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
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
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?
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.
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.
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.
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?
The United States Supreme Court Ruling • What did the United States Supreme Court rule about the government's actions in this case?
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?
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?
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?
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
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
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
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
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?
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? • LA follows Berkovitz • (added 31 Oct)
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?
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?
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 and the drunk assaulted people • Legal results • Is an assault covered by the FTCA? • What do you argued that can put this case under the FTCA? • Is this like Allen or Berkovitz?