Slides - Medical and Public Health Law Site

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Suing the Federal Government
History
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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
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1855
Administrative tribunal to review claims and make
recommendations to Congress
Later Congress made the decisions binding
 Not an Art III 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
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Went into effect in 1945
All private bills before then
Allowed tort claims
 Looks to the law of the state where the tort
occurred for the standards for the tort
We will discuss the procedure under the FTCA
later.
Dalehite v. U.S., 346 U.S. 15 (1953)
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Texas City Disaster
 http://www.local1259iaff.org/disaster.html
Why is the TVA producing ammonium nitrate
fertilizer?
 What are other uses of ammonium nitrate?
Where is it going?
Why might a ship also be carrying explosives?
The General Claim
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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
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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 Statutory Defense
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(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?
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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
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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) - This Clears up the Cloud
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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?
Background on Vaccine Liability
Polio Vaccine
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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
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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
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Undermined confidence in vaccines
1965 - 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
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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
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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
Berkovitz by Berkovitz v. U.S., 486 U.S.
531 (1988)
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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?
Varig Airlines (in Berkovitz)
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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
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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?
Pandemic Flu Vaccines
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What are the legal issues?
How can the feds deal with these?
What about rolling out an experimental vaccine?
What if the feds make you take the experimental
vaccine?
 And it harms you?
 What does Allen tell us?
Public Readiness and Emergency Preparedness Act
 Creates broad immunity for government and
private contractors
FTCA Procedure
Causes of Action under the FTCA - Sec
2672
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The head of each Federal agency ... may consider,
ascertain, adjust, determine, compromise, and settle any
claim for money damages against the United States for
injury or loss of property or personal injury or death
caused by the negligent or wrongful act or omission of
any employee of the agency
while acting within the scope of his office or employment,
under circumstances where the United States, if a private
person, would be liable to the claimant
in accordance with the law of the place where the act or
omission occurred
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Limitations on Liability - Sec 2674
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The United States shall be liable, respecting the provisions of this
title relating to tort claims, in the same manner and to the same
extent as a private individual under like circumstances, but shall
not be liable for interest prior to judgment or for punitive damages.
If, however, in any case wherein death was caused, the law of the
place where the act or omission complained of occurred provides,
or has been construed to provide, for damages only punitive in
nature, the United States shall be liable for actual or compensatory
damages, measured by the pecuniary injuries resulting from such
death to the persons respectively, for whose benefit the action was
brought, in lieu thereof.
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Exceptions to the FTCA - § 28 USC Sec
2680
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http://biotech.law.lsu.edu/cases/immunity/ftca_ex
ceptions.htm
(h) originally did not include the provision for law
enforcement officers.
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Bivens v. Six Unknown Named Agents,
403 U.S. 388 (1971)
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Bivens recognized that there is a direct action
against federal employees for violations of
constitutional rights
 Bivens is a personal action, not an official
capacity action
 Why weren't Bivens actions originally covered
by the FTCA?
Why might you use Bivens rather than state tort
remedy?
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2680(h) - intentional torts by police
officers - revised after Bivens
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Has become a substitute for a Bivens action for
covered officers.
 When would a Bivens action still be possible?
 When would an ordinary tort action be
possible?
A recent case allows a Bivens action against
federal medical personnel in a detention center.
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Administrative Procedural Requirements Sec 2675
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An action shall not be instituted upon a claim against the
United States for money damages for injury or loss of
property or personal injury or death caused by the
negligent or wrongful act or omission of any employee of
the Government while acting within the scope of his
office or employment, unless the claimant shall have first
presented the claim to the appropriate Federal agency
and his claim shall have been finally denied by the
agency in writing and sent by certified or registered mail.
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What if the Agency Does Not Act on the
Claim?
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The failure of an agency to make final disposition
of a claim within six months after it is filed shall,
at the option of the claimant any time thereafter,
be deemed a final denial of the claim for purposes
of this section.
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Filing a Claim is Jurisdictional
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This is an administrative compensation scheme, so it is subject to
exhaustion of remedies
 You file a claim with the agency with 2 years of the accidence
You can only go to court after the agency rules on the claim or
after six months
 "The failure of an agency to make final disposition of a claim
within six months after it is filed shall, at the option of the
claimant any time thereafter, be deemed a final denial of the
claim for purposes of this section."
If you do not comply with this requirement, your case will be
dismissed and if the 2 years has elapsed, you will be prescribed.
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