The Legal and Policy Implications of Reinstituting Smallpox Vaccinations
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Edward P. Richards
Edward P. RichardsDirector, Program in Law, Science, and
Public HealthHarvey A. Peltier Professor of LawPaul M. Hebert Law CenterLouisiana State UniversityBaton Rouge, LA [email protected]://biotech.law.lsu.edu
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Legal Regulation of Vaccines
State Regulation of Variolation Boston Smallpox Epidemic 1721 Coton Mather Advocated Variolation
for the 1st Time in the US “Vaccine Agents” in Early 1800s
Assured Proper Preparation of Cowpox Vaccine
Raised Money to Support Vaccination
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Vaccine Agent Legislation 2 Stat. 806 (1813) “...to preserve the genuine vaccine
matter, and to furnish the same to any citizen of the United States, whenever it may be applied for, through the medium of the postoffice...”
Repealed in 1822 after an Alleged Vaccine Related Outbreak of Smallpox
Left to States Until 1902
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FDA Regulation Vaccines Must Be Safe and Effective
to be Approved for General Use Smallpox is an Investigational New
Drug – IND Allows Control of Distribution Raises Difficult Consent Issues
Can a New Vaccine be Shown to be Effective?
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Liability for Primary Vaccine Injuries
Informed Consent Was the Patient Warned of the Risk? Is it 1/1,000,000 or 1/10 for the
Immunosuppressed? Negligent Screening
Is it reasonable to rely on self-screening when the clinical trials demanded medical testing?
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Liability for Secondary Spread Spread to Family Members
Is a Warning to the Vacc7inee Enough?
Should there be Investigation? Spread to Patients by Health Care
Providers Should Vaccinated Persons be in the
Workplace? Should Patients be Warned?
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Employment Discrimination Issues
What Happens When Health Care Providers and Others Refuse Vaccination?
What if they Cannot be Immunized? Must they be Removed from
Emergency Preparedness Teams? What about Other Workplace
Sanctions?
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Vaccine Manufacturer Liability
Products Liability Informed Consent These Can be Sheltered under
Various Federal Laws
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Mass Vaccination Programs Federal Policy
No Mandatory Vaccinations Vaccinate Every Exposed Person, Regardless
of Contra-indications Exposed Persons Should be Quarantined No One in Quarantine unless Immunized
What Happens to Unimmunized, Exposed Persons?
Immunosuppressed Persons who Do Not Develop Immune even if Vaccinated?
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Homeland Security Act Solution "For purposes of this section, and subject
to other provisions of this subsection, a covered person shall be deemed to be an employee of the Public Health Service with respect to liability arising out of administration of a covered countermeasure against smallpox to an individual during the effective period of a declaration by the Secretary under paragraph (2)(A)."
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FTCA Act Immunity
FTCA Claims Allows Medical Malpractice Does not Allow Products Liability Does not Allow Punitive Damages
Procedure Must File Administrative Claim First May Then Sue if Claim is Not Resolved
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Discretionary Authority Varig Airlines, 467 U.S. 797 (1984).
FAA Could Spot Check Airplanes Berkovitz by Berkovitz v. U.S., 486
U.S. 531 (1988) FDA is Liable if it does not Follow its
Own Rules in Approving Batches of Vaccine
Key – is the Agency Making a Policy Choice?
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Atomic Fallout Cases
Government liability cannot logically be predicated on the failure of test-site personnel to go beyond what the operational plans specifically required them to do. If, as the plaintiffs maintain, the AEC delegated "unfettered authority" to a Test Manager and his subordinates to implement public safety programs, this simply compels the conclusion that those officers exercised considerable discretion. Their actions, accordingly, also fall within the discretionary function exception.
It is irrelevant to the discretion issue whether the AEC or its employees were negligent in failing to adequately protect the public.
Allen v. United States, 816 F.2d 1417 (10th Cir. 1987)
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What Triggers This?
Secretary of HHS Must Make a Declaration
Must Specify the Covered Actions Immunity Only Extends to Covered
Use of Vaccine Does Not Apply to Unauthorized Use
or Blackmarket Includes People and Institutions
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What is Excluded?
Probably Worker’s Comp Not a Liability Claim If Included, then the Injured Worker
has no Compensation Black-market and Direct
Inoculation
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What About Covered Injuries? If the Government is Careful in
Establishing Policies, then there is no Liability
Private Insurers Might Decline Because this is Related to Military Defense
What Are Alternatives? Swine Flu Model National Childhood Vaccine Injury
Compensation Act Model
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