Suing the Federal Government
FTCA II
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
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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?
Epilog
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National Childhood Vaccine Injury Compensation
Act
Autism Scam
 Based on fraudulent research
 Tries to get around the act by blaming the
preservative
Attacks on adult vaccines like anthrax
Undermined the vaccine law system
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
Tort Claims in Louisiana
Raw Oysters
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What do oysters eat?
Hepatitis A - traditional
 Liver disease
 some die
vibrio vulnificus - the new threat
 acute liver disease and failure
various other nasty vibrios
This is why God made deep fat fryers
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State Warning
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THERE MAY BE A RISK ASSOCIATED WITH
CONSUMING RAW SHELLFISH AS IS THE CASE
WITH OTHER RAW PROTEIN PRODUCTS. IF YOU
SUFFER FROM CHRONIC ILLNESS OF THE
LIVER, STOMACH OR BLOOD OR HAVE OTHER
IMMUNE DISORDERS, YOU SHOULD EAT THESE
PRODUCTS FULLY COOKED.
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The Oyster Industry and Warnings
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Did they support the reporting regulations?
What was their concern?
What would you tell them as a products liability
lawyer?
How did their position affect the final form of the
law?
What should it really say?
Is this like fugu - puffer fish - sushi?
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Where Does the Warning Have to be
Posted??
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Section 23:006-4 of the Sanitary Code requires
that all "establishments that sell or serve raw
oysters must display" a prescribed warning "at
point of sale." The establishment has discretion in
determining what method may be used to convey
the warning because the warning can be
conveyed by a sign, menu notice, table tent or
other clearly visible message.
What is the critical language?
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Gregor v. Argenot Great Central Insurance
Co., 851 So.2d 959 (La. 2003)
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What happened to plaintiff?
 Preexisting illness?
 What if he did not have a preexisting illness?
Where was the sign posted?
Where did plaintiff eat?
 Did he see the sign?
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The Claims
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Who did the plaintiff sue?
What was the comparative fault assessment?
What is the plaintiff's negligence theory against
the state?
 What is the causation issue?
Why was DHH assessed so much fault?
What is the state's defense?
How does plaintiff attack this defense?
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State Immunity
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Sovereign immunity was abolished
 How does this change the construction of the
immunity provision as compared to the construction
of the FTCA?
The Discretionary Authority Statute:
 "Liability shall not be imposed on public entities or
their officers or employees based upon the exercise or
performance or the failure to exercise or perform their
policymaking or discretionary acts when such acts are
within the course and scope of their lawful powers and
duties. “
 La. R.S. 9:2798.1
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What is the purpose of La. R.S. 9:2798.1?
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Section D of La. R.S. 9:2798.1 explains that its
purpose "is not to re-establish any immunity
based on the status of sovereignty but rather to
clarify the substantive content and parameters of
application of such legislatively created codal
articles and laws and also to assist in the
implementation of Article II of the Constitution of
Louisiana."
Court's Analysis
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The Court's use of Berkowitz is confusing.
 It rejects the Fowler's court's reliance on Berkowitz
because the LA statute is different
 It then appears to use an analysis that is consistent
with Berkowitz and other FTCA cases in its resolution
of the case
How is this case like Berkowitz?
 What is the role of the regulation?
 How is the agency arguing that the reg does not
apply?
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What was the Real Negligence of DHH?
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Did it really allow inspectors to decide what point of sale
meant?
 “DHH had a mandatory duty to properly enforce the
sanitary code. La. R.S. 40:4A. We find that DHH was
negligent in failing to properly train its sanitarians and
failing to properly provide them with interpretations of the
Sanitary Code terminology, specifically as to what the term
"point of sale" means.”
Was the restaurant also liable?
 Bad oysters or bad warning?
 How did the court modify the allocation of fault?
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Public Health Risks
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Does the health department have a duty to warn
about risks it knows of?
What if it warns physicians, but not the public?
Should it be liable for not abating a risk to the
public?
 What about testing the oyster beds?
 What did the health department find about the
origin of the oysters in this case that should
worry you?
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Hepatitis in Bathhouses
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Data from health studies in the mid-1970s showed a huge
risk of hepatitis b in bathhouses
 Should the health department have warned the public?
 Should they have closed down the bathhouses?
 What about AIDS in the bathhouses?
What if the statute says the government shall protect the
public?
 What does the public assume from government
inaction?
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