The Legal and Policy
Implications of Reinstituting
Smallpox Vaccinations
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@lsu.edu
http://biotech.law.lsu.edu
LSU Progam in Law, Science, and
Public Health
2
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
LSU Progam in Law, Science, and
Public Health
3
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Repealed in 1822 after an Alleged Vaccine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
LSU Progam in Law, Science, and
Public Health
4
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?
LSU Progam in Law, Science, and
Public Health
5
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?
LSU Progam in Law, Science, and
Public Health
6
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?
LSU Progam in Law, Science, and
Public Health
7
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?
LSU Progam in Law, Science, and
Public Health
8
Vaccine Manufacturer Liability



Products Liability
Informed Consent
These Can be Sheltered under Various
Federal Laws
LSU Progam in Law, Science, and
Public Health
9
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?
LSU Progam in Law, Science, and
Public Health
10
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)."
LSU Progam in Law, Science, and
Public Health
11
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
LSU Progam in Law, Science, and
Public Health
12
Discretionary Authority

Varig Airlines, 467 U.S. 797 (1984).


Berkovitz by Berkovitz v. U.S., 486 U.S.
531 (1988)


FAA Could Spot Check Airplanes
FDA is Liable if it does not Follow its Own
Rules in Approving Batches of Vaccine
Key – is the Agency Making a Policy
Choice?
LSU Progam in Law, Science, and
Public Health
13
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)
LSU Progam in Law, Science, and
Public Health
14
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
LSU Progam in Law, Science, and
Public Health
15
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
LSU Progam in Law, Science, and
Public Health
16
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
LSU Progam in Law, Science, and
Public Health
17