The Legal and Policy Implications of Reinstituting Smallpox Vaccinations.

The Legal and Policy Implications of Reinstituting Smallpox Vaccinations

LSU Progam in Law, Science, and Public Health

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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Repealed in 1822 after an Alleged Vaccine Related Outbreak of Smallpox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

The Legal and Policy Implications of Reinstituting Smallpox Vaccinations.

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