The Legal and Policy Implications of Reinstituting Smallpox Vaccinations

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The Legal and Policy Implications of
Reinstituting Smallpox Vaccinations
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Edward P. Richards

• Edward P. Richards
• Director, Program in Law, Science, and Public
  Health
• Harvey A. Peltier Professor of Law
• Paul M. Hebert Law Center
• Louisiana State University
• Baton Rouge, LA 70803-1000
• richards_at_lsu.edu
• http//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• Repealed in 1822 after an Alleged Vaccine Related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 Workers 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