In response to
scientists' warnings about an avian influenza pandemic, President
George W. Bush recently called for the creation of a $7.1 billion
influenza preparedness strategy. The cornerstone of his plan is
As things now stand, however, the country does not have the
resources to make this plan a reality: vaccine makers face too many
legal obstacles and too much potential liability to make the
investments needed to combat avian flu. Congress has dealt with
this problem before, with respect to childhood vaccinations, and
should respond today similarly. Extending the Vaccine Injury
Compensation Program (VICP) to cover more vaccines will give
vaccine manufacturers breathing room to innovate and bring their
life-saving products to market, to the benefit of all
Leader Bill Frist (R-TN) and the House leadership are in final
negotiations over a provision to help the vaccine industry meet its
challenges. The provision, which is attached to the defense
appropriations bill, offers liability protection for a limited
number of vaccines deemed critical for responding to an avian
influenza pandemic. However, it is unclear what kind of
compensation, if any, would be included to cover the small number
of people injured by vaccines.
While this effort represents a good first step towards shielding
the vaccine industry from litigation, Congress will have to revisit
the issues of expanding liability protections to more vaccines and
improving and extending compensation programs for those injured by
Low Prices, Unlimited
experts estimate that it costs nearly $900 million to bring a new
vaccine to market.
Despite the increasing costs of research, development, and
compliance with Food and Drug Administration regulations, major
government programs, such as the Vaccines for Children Program,
demand deep discounts that have made many vaccines unprofitable.
have fallen prey to the tort monster in America. Unpredictable
lawsuits obtain huge verdicts on shaky foundations, stifling the
ability of vaccine makers to compete and innovate.
Many have criticized the courtroom's ability to weigh the complex
scientific and statistical evidence involved in vaccine liability
Buffeted by successive waves of courtroom attacks and huge legal
expenses over the past three decades, many firms now avoid the
potential liability posed by vaccines.
To address vaccine
shortages and the resulting dangers to public health, Congress
established VICP in 1986. Funded by an excise tax imposed on
vaccine doses, VICP was intended to protect the makers of childhood
vaccines from legal liability. VICP was designed to be a less
adversarial alternative to litigation; victims who can prove that
their injuries fall within certain scientifically established
boundaries receive full compensation for economic losses without
showing fault and without expensive, time-consuming litigation.
Furthermore, plaintiffs can decide to opt out of VICP and sue in
state or federal court if they choose-though subject to some
Congress Should Give Vaccines a
Shot in the Arm
In the VICP,
Congress has a model that it can use to provide strong liability
protections for vaccine makers while providing fair and prompt
compensation to those injured by vaccines. While other "no-fault"
compensation systems can become prohibitively expensive, the
concept works well for vaccines because there are few injuries.
A re-vamped VICP
has the potential to create a legal atmosphere for vaccine
manufacturers similar to that which existed during the "golden age"
of vaccines. Because VICP is funded with excise taxes on vaccine
doses and provides relatively hassle-free compensation, it can also
approximate the kind of insurance that consumers might purchase for
themselves on the private market. To achieve these objectives,
Congress should take the following steps:
to cover most or all vaccines.
Liability protection for more
vaccines will prevent a single lawsuit from destroying an entire
company. Congress has already recognized this principle by
extending VICP coverage to common influenza vaccines.
Covering more vaccines is important when, as in the case of
influenza, only one company supplies the vaccine, putting that
vaccine at high risk. Liability protection will also speed progress
in creating vaccines to treat different ailments, because
manufacturers will know the protection will be there. Moreover,
increased diversity in vaccines can also help to cross-fertilize
ideas from one kind of vaccine to another, improving existing
Make VICP the
exclusive remedy for participants. One of the most important
elements of liability protection is certainty, something that is in
short supply in today's unpredictable legal environment. If, after
choosing to participate in VICP, claimants are free to sue in court
to obtain a higher judgment, liability protection will mean little.
Congress should discourage claimants from "gaming" the system by
requiring those receiving vaccines to decide up front whether or
not they will participate in the VICP protection. If they choose
not to participate in the program, Congress could require claimants
to bring their cases in federal court under strict compensation
standards. Congress might also choose to indemnify vaccine makers
from the expenses of the resulting lawsuits.
liability protection for the whole vaccine. As has been seen
with thimerosol, a vaccine preservative that has been the subject
of several lawsuits despite that the lack of evidence linking it
with vaccine injuries, trial lawyers will find any way possible to
thwart the intent of Congress and circumvent VICP's protections.
Congress should provide that VICP prospectively applies to all
vaccine components, including preservatives and other
While Congress originally intended VICP to be
an "expeditious, less adversarial, and fair system," it still
retains many of the trappings of litigation.
For the small number of VICP claims that require hearings, Congress
might provide for court-retained expert witnesses to offer unbiased
testimony about causation reflecting the current state of
scientific knowledge. By providing strong liability protections to
vaccine makers, this could also encourage the companies themselves
to help claimants determine the cause of their injuries. Similar
results have been achieved in Scandinavian countries that have
adopted "no-fault" compensation schemes for medical errors: doctors
and nurses there (the would-be defendants in medical malpractice
lawsuits) now help injured patients fill out their claim forms and
share relevant information surrounding their cases.
excise tax for low-income or high-priority participants.
Because VICP is funded with excise taxes imposed on vaccine doses,
it is more like an insurance program than a litigation-based
system. And, unlike the regressive "tort tax" that everyone pays
regardless of their income, an excise tax on vaccines could be
waived, raised, or lowered by the government. This could prove
useful for encouraging low-income individuals and high-priority
populations (such as the elderly or health care workers) to
participate in vaccination programs.
Keeping in mind
the dual objectives of promoting a robust vaccine industry and
encouraging public confidence in vaccines, Congress should take the
steps needed to bring about a second "golden age" of vaccines that
will benefit all Americans. Of the solutions available, a retooled
and expanded VICP, or some similar program, is the best opportunity
to protect vaccine makers from lawsuits while quickly and fairly
compensating injured parties. While the vaccine provision currently
pending before Congress would be a good first step towards offering
the vaccine industry the liability protection it needs, Congress
will have to revisit the issues of extending the number of vaccines
protected and providing fair and just compensation to those injured
Randolph W. Pate, J.D., MPH, is
Visiting Fellow in the Center for Health Policy Studies at The