Sunday, July 26, 2009

Legal immunity set for swine flu vaccine makers:  What are the implications?

AP Medical Writer Mike Stobbe got a swine flu vaccine scoop--yet the
news is four weeks old. It turns out that DHHS Secretary Sibelius has
not only given immunity to the makers of Tamiflu and Relenza for
injuries stemming from their use against swine flu. She also granted
immunity to future swine flu vaccines and "any associated adjuvants,"
which was published in the June 25, 2009 Federal Register. Here is the
start of his story:

      The last time the government embarked on a major vaccine campaign
against a new swine flu, thousands filed claims contending they
suffered side effects from the shots. This time, the government has
already taken steps to head that off.

      Vaccine makers and federal officials will be immune from lawsuits
that result from any new swine flu vaccine, under a document signed by
Secretary of Health and Human Services Kathleen Sebelius, government
health officials said Friday.

      Since the 1980s, the government has protected vaccine makers
against lawsuits over the use of childhood vaccines. Instead, a
federal court handles claims and decides who will be paid from a
special fund.

      The document signed by Sebelius last month grants immunity to
those making a swine flu vaccine, under the provisions of a 2006 law
for public health emergencies. It allows for a compensation fund, if

However, the compensation issue is more difficult than portrayed by
Stobbe. The special vaccine court to which Stobbe refers applies only
to specially designated vaccines, excludes most adult vaccines, and
swine flu is not a designated vaccine for which compensation can be

The 2006 Public Readiness and Emergency Preparedness Act (PREPA)
allows the DHHS Secretary to invoke almost complete immunity from
liability for manufacturers of vaccines and drugs used to combat a
declared public health emergency. PREPA removes the right to a jury
trial for persons injured by a covered vaccine, unless a plaintiff can
provide clear evidence of willful misconduct that resulted in death or
serious physical injury, and gets permission to sue from the DHHS
Secretary. There has been no government funding of its potential
compensation mechanism, to date. Furthermore, a PREPA declaration
explicitly shields "government program planners" who arranged for the
liability waiver.

Pharmaceutical companies making swine flu vaccine today may have
demanded immunity from liability before agreeing to begin a crash
program to manufacture H1N1 vaccine for the government. According to a
1978 report by the National Academy of Sciences, something similar
happened with the 1976 swine flu program:

      ... all manufacturers made plain that they would not insure
themselves, not even temporarily. Instead they put off plans to bottle
their vaccine; pending legislation they would keep the stuff in bulk.
Each week’s delay in moving from bulk to bottles assured at least as
much delay in starting inoculations. Thus ended hopes of immunizing
anybody in July or even August...

      Behind Merrell’s firmness, there almost certainly was fear of the
intentions of the casualty insurers. In May it was no secret that at
least some major firms wanted to steer clear of swine vaccine. As
early as April 8 Merck had been warned by its primary insurer that
coverage for swine vaccine was “considered” not “feasible … at
virtually any price.” So Merck's President had written Mathews and
everyone else in sight.

      Merrell, then about to switch insurers (for unrelated reasons) is
reported to have been told by its new one something of the same sort
at about the same time. We do not know precisely what was made of
this, where in Merrell’s management. We do know that the issue was
reviewed again, in June, by the insurer with the same result, a “no.”
But we assume that Merrell’s counsel knew in May what the insurer had
already warned in April. However that may be, it shortly would turn
out that all insurers saw the swine flu program much alike: not for

Here is the problem: once the PREP Act is invoked to shield
manufacturers from liability, the pharmaceutical firms have no
financial incentive to make the safest product, and have a negative
incentive to test it for safety. As long as they do not deliberately
harm consumers of the product, they will not be liable for damages.

Are you following this argument closely? In order to avoid having
prior knowledge of possible harm to users of the product, for which
they could be found liable, it is in the manufacturers' best interest
to know as little as possible about adverse reactions caused by their

Thus manufacturers can be expected to perform minimal testing, as they
have been incentivized by PREPA to avoid learning of potential harms
related to their product. Thus the speed at which the product will be
distributed serves two purposes: it provides the needed excuse to
avoid adequate testing, as well as providing rapid vaccine availability.

It is worthwhile to go back and consider the reason for passing PREPA
in 2006: fear of an avian flu pandemic, if the avian flu virus mutated
to enable person-to-person spread. Avian flu then had a 70% death
rate. Faced with such a potentially devastating disease, it perhaps
made sense to create legislation to permit rapid deployment of drugs
and vaccines without adequate testing, and issue a liability shield
for those involved in the process.

But the H1N1 flu has only caused 302 US deaths though CDC estimated
over one million Americans had been infected. Instead of 70%, H1N1's
death rate is under 0.03%. Therefore, this virus in no way justifies
the risks the population is being asked to take: receiving vaccines,
and perhaps experimental adjuvants, which their manufacturers have
been encouraged not to test, with no prospect of compensation for
illness or death that might result.

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
W  207 288-5081 ext. 1220
C   207 522-5229
H   207 244-9165
pager 207 818-0708