Compensation and Liability for Vaccines
The Special Case of Vaccines for
Bioterrorism Agents
Edward P. Richards
Director, Program in Law, Science, and Public Health
Harvey A. Peltier Professor of Law
LSU Law Center
Baton Rouge, LA 70803-1000
richards@lsu.edu
http://biotech.law.lsu.edu
There is Nothing New Under the Sun


Vaccines for bioterrorism agents pose the
extreme cases of vaccine law and policy
 Consent versus Mandated Vaccinations
 Liability
 Compensation
 Market issues for one-shot preventive
measures
These are still controversial for routine vaccines
Special Problems for Bioterrorism Agents



No effectiveness data
 What if it does not work?
Limited clinical data because you will not use them until
there is a emergency
 Emergency use means poor screening and follow-up
 Emergency use means a psychologically loaded
environment which is very conducive to epidemic
hysterical illness
Timeframe – we are using 30 year old smallpox vaccine liability can be a time bomb
Why Worry about Liability for Vaccine
Manufacturers?
Will They Make the Vaccine without
Liability Protections?




Polio – 1950s and 1960s
Swine Flu – 1970s
Childhood Immunizations – 1980s
Bioterrorism Agents – 2000s
 Liability is at an all time high
 Why might it not matter to a manufacturer?
What if They Will Make the Vaccine
without Liability Protections?
If the manufacturer will make it without
protection, are there other reasons to
provide protection?
Is Liability the Basis for Compensation?


What if there is not enough insurance to pay the
claims?
What if the manufacturer declares bankruptcy or
uses other legal strategies to dodge the liability?
Will Liability Undermine Epidemiology?


The real secret of effect personal injury law
 Get clients to friendly doctors for primary
treatment
 Then all the medical records support your claim
 An issue in Swine Flu
The legal system will compensate people without
regard to scientific evidence
What about Health Care Providers?


They must have protection or they will not give
vaccinations
It must be complete and not dependent on their
medical malpractice insurance
Separate Liability from Compensation


If you have a compensation system, fund it
separately from liability determinations
The federal government can seek indemnification
based on liability if liability is seen as an
important market discipline
There is only one effective mechanism to
provide complete protection


Substitute the federal government for the defendant
 Swine flu
 Smallpox (Sec 304)
 Federal Community Health Centers
 Most all federal employees
This does not prevent the federal government from
seeking contribution or indemnification from the
manufacturer for bad acts
Compromise Solutions


Federal indemnification
 You have to deal with the litigation
 Gives a judge the chance to find a reason why the feds
do not have to indemnify you
Safety Act
 Depends on the secretary’s certification
 Could be attacked in court
 Allows litigation, which creates chances for the judges
to undermine the protections
The Role of Compensation
Why do People Take Vaccines?



People take vaccines when are more frightened of
the disease than of the vaccine
People make other people take vaccines when
they are more worried about their spreading
disease than they are worried about other
people’s choices
The purpose of education is to make them more
frightened of the disease than the vaccine
Is compensation just a bribe to make the
vaccine more attractive?

Smallpox compensation program:
 (C) who has volunteered and been selected to
be a member of a smallpox emergency
response plan described in subparagraph
 (B) prior to the time at which the Secretary
publicly announces that an active case of
smallpox has been identified either within or
outside of the United States;
Who Should You Bribe?



Who really cared about compensation?
 Hospitals and employers
Not addressed by the smallpox comp program
 All benefits are secondary to worker’s comp
and insurance benefits
 No reimbursement for the benefits costs and
other costs to the hospital
304 Fails this test
What about the Individuals?



Does compensation really make you more likely to
take what you see as a dangerous vaccine?
Does a compensation system increase the fear of
vaccinations?
Public acceptance of vaccines has not increased
after National Childhood Vaccine Injury
Compensation Act
What Should a Compensation Program
Look Like?






Administrative review
Based on an injury table
Funded by federal funds not tied to the vaccines
All cases reviewed by independent medical
examiner, including physical exam in cases based
on physical diagnosis
Realistic compensation levels
Reimbursement of third party expenses