Saturday, September 26, 2009

Hospitals and States Mandating Swine Flu Vaccinations Don't Get It: They will be on the Hook for all Liability for Injured Recipients

A domino effect is cascading through the country, as officials rush to impose vaccination mandates on citizens (Massachusetts) and health care employees (New York), as well as mandate influenza (seasonal +/-swine) vaccinations in many other healthcare systems and hospitals.  Many state laws are written such that in a declared emergency, vaccination or, alternatively, quarantine are required.  The tsunami mandating vaccinations (see WaPo article) is occurring in a vacuum of information about the incidence and impact of the diseases citizens will be forcibly protected against, and the effectiveness and safety of mandated vaccines.  Meantime, the institutions mandating the vaccinations appear clueless about the massive liability for vaccine injuries they are assuming as a result of these mandates.

1)  Low disease incidence of seasonal influenza viruses

Currently (this week) only 1% of circulating influenza viruses in the United States are of the "seasonal" type.  Seasonal flu outbreaks usually start late in the season:  November at the earliest.  It takes 7-10 days to develop  a strong immune response.  Vaccine recipients who are elderly or have weak immune systems have a rapid decline in antibody levels over the few months following vaccination.  It makes no sense to vaccinate these people early in the season, as they may lose vaccine protection before flu season is over.

And since only 1% of currently circulating flu viruses will be covered by the seasonal vaccine, it hardly makes sense to use that vaccine at all, at this point in time.  If such viruses increase in the population as time passes, vaccinations could be started later.  (Those with good memories may recall that seasonal vaccinations are normally offered in October and November.)

2)  Uncertain swine flu vaccine effectiveness and adverse effects

Swine flu vaccine generates good antibody levels, but we still don't know how well it prevents influenza disease.  Nor do we know how safe it is, since pretty much all the experts agree that until millions receive a vaccine, it is impossible to accurately identify its adverse effects. 

Now, a story out of British Columbia's Center for Disease Control indicates that people who have received flu vaccine in a previous year may be more susceptible to developing swine flu (the disease).  Odd as this sounds at first, it is a fact that receiving certain animal vaccines increased susceptibility to the disease the vaccine was designed to prevent.  Such vaccines were taken off the market.

UPDATE:  Most of Canada's provinces have suspended seasonal flu shots for those under 65 due to this study, since it suggests last season's flu shot enhances susceptibility to swine flu infection.  Apparently Canada fears this year's seasonal flu shot may do so as well.  But those over 65 are more susceptible to seasonal flu, and less susceptible to swine flu, than younger age groups, so they are the appropriate target group for seasonal flu vaccine. 

We need to wait to learn if this finding (higher risk of swine flu associated with prior vaccination) is borne out by other studies, but it does offer a reminder that vaccinations can have unanticipated effects that are a lot more serious than a sore arm. By the way,  CSL's swine flu "vaccine triggered [systemic] side-effects including headache, myalgia, fever and nausea in more than 60 per cent of trial participants."

From Bloomberg:
“This is the biggest mass vaccination we have done in world history and we are doing it on data so far which shows this virus is not a lot worse than seasonal influenza,” said Peter Collignon, director of infectious diseases at the Australian National University’s medical school. “There is a real worry that the fear makes us do things out of proportion to the risk."
“If this was causing 1 or 2 percent mortality and spreading quickly, I would be the first person up there with my arm,” Collignon said. As it is, “I will put my arm up next February or March when I have seen more data.”

Swine flu killed 170 people in Australia, and the epidemic peaked there in July:  a far cry from predictions of many thousands of deaths.  Now Australia plans to start swine flu vaccinations; but it is likely most of the population is already immune as a result of widespread exposure.  (When Australians enrolled in swine flu vaccine trials, 30% of subjects were found to be immune already.) 

3)  Workplaces and states that mandate swine flu vaccinations don't have liability waivers

But everyone else involved in the swine flu vaccination process does have a liability waiver:  this includes manufacturers, distributors, medical professionals who administer the vaccine and government program planners who worked on the vaccination program.  Read it in the Federal Register of June 25, 2009.

It says that licensed individuals authorized to prescribe, administer and dispense the vaccine have liability waivers, but there are no other "qualified persons" (pursuant to section 319F-3[i][8][B]) who are given this immunity, (such as employers of these persons, or states).  Unless there has been a new government declaration extending immunity to these entities since June 25, of which I am unaware, hospitals, other health care institutions and states appear to be inviting lawsuits as a result of employee or state mandates they are issuing.

Since the newly created federal compensation program for swine flu vaccine injuries has both a low payment cap and prohibits access to the U.S. legal system, the occurrence of employee mandates virtually guarantees that any vaccine injuries suffered by employees will result in lawsuits against employers, the only "deep pocket" left liable.

It appears that some employers may have already dug themselves a hole by issuing blanket mandates, since some states guarantee vaccine exemptions on the basis of religious beliefs or union contracts.

4.  Vaccine Mandates, Exemptions and Legal Implications

See this Congressional Research Service report on state provisions for vaccine exemptions.  And this book chaper by Malone KM and Hinman AR, page 273 (current in 2001) for discussion on vaccine exemptions, constitutionality of mandates, and list of 48 states with religious exemptions and 15 with philosophic vaccine exemptions.  Also see this 2008 ACLU Report by Annas G, Mariner WK and Parmet WE, titled "Pandemic Preparedness: The Need for a Public Health--Not a Law Enforcement/National Security--Approach."  It "examines the relationship between civil liberties and public health in contemporary U.S. pandemic planning and makes a series of recommendations for developing a more effective, civil liberties-friendly approach."  An excerpt:  
"It is worth noting that federal legislation has given vaccine manufacturers immunity
for the vaccines they produce in response to a public health emergency. The CDC has also called for broad immunity statutes to protect “first responders” and unlicensed health professionals who respond to emergencies.  These proposals are viewed as a form of “Good Samaritan” statute, but should be resisted in the pandemic setting for at least three reasons:
(1) almost all of the people and corporations covered are not volunteers, but are doing a job that they have been trained for and are being paid for and should be accountable and responsible for their actions
(2) negligent Samaritans are no good—they harm rather than help;  and
(3) immunity [from liability] encourages negligent and intentional violations of individual rights that breeds public distrust."


Hillcrest Toronto said...

Apparently, here in Canada we will not get swine flu vaccines anytime soon. We have been told to wash hands more often, though. I guess it was just to shut us up.


Meryl Nass, M.D. said...

But when vaccine is available in Canada, it is slated to include novel, squalene-containing adjuvants. Be prepared.