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Flu Vaccine Redux: Vaccine Makers Immunized Against Product Liability?

Swine Flu

In my previous post about the flu vaccine, I demonstrated that clinical studies comparing vaccinated groups against similar non-vaccinated group showed very little absolute benefit (i.e. single digit improvement) which fluctuated by year.  This stands in stark contrast to the 50-60% effective rate advertised each flu season via various media outlets.

However, aside from gawking at some of the more questionable common ingredients in a typical flu vaccine shot (like formaldehyde), I didn’t do more research not only on the harms but also the mortality risk related to the flu.  So I did more research on both the harms and the magnitude of flu mortality in the US and came to some very interesting pieces of information, which I will share below by starting with what I found related to vaccine harms and then do a separate post on flu mortality statistics.

Flu Vaccine Manufacturers Immune from Tort Liability

In order to research the potential harm attributed to flu vaccine injections, I thought it would be interesting to see to what extent negligent manufacturers were sued by people injured by their vaccines, reasoning perhaps some other interesting facts would come to light along similar lines of the famed 1999-2004 Merck Vioxx fisaco.  So I simply did a Google search for “flu vaccine manufacturer lawsuits” and the first result was a 2009 NBC News article explaining that “Legal immunity set for swine flu vaccine makers.”  I vaguely remember 2009 as the year of the swine flu “pandemic,” but at the time, outside the media hype, I never realized everything that took place:

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.

My first thought was that it’s a little ironic that these particular manufacturers have lawsuit immunity from injuries that may result from their vaccines.  It also wasn’t clear that this move by HHS just applied to only swine flu vaccine manufacturers.  Finally, right, wrong, or indifferent, lawsuits are one traditional way patients can seek redress and accountability against negligent vaccine manufacturers.  This article led me to ask two further questions: 1. Is this still the case today with negligent vaccine manufacturers? and 2. What is this 1980s law briefly mentioned?

So, after finishing the NBC News article, I hit the back button and quickly came upon a 2011 Christian Science Monitor article summarizing that “Parents can’t sue drug firms when vaccines cause harm, Supreme Court says.”  This 2010 case wasn’t about flu vaccine harms per se but one for DTP instead:

The high court decision stems from the April 1992 administration of a vaccine to the Bruesewitzes’ then-infant daughter, Hannah. After being injected with the diphtheria-tetanus-pertussis (DTP) vaccine, Hannah suffered a series of seizures that left her developmentally disabled. Lawyers for the family say she will require medical care and supervision throughout her life.

The Bruesewitzes took their claim to the special Vaccine Court, but a month before they filed their petition, Hannah’s seizure disorder was dropped from a listing of injuries covered under the Vaccine Injury Act. The Vaccine Court ruled that the family would receive no compensation.

The family then filed suit in state court alleging that Wyeth Inc., the vaccine manufacturer, was negligent because it could have produced a safer version of the vaccine, but failed to do so. Lawyers for the family argued that the company should have upgraded its vaccine with a less dangerous version.

Wyeth lawyers countered that the federal Vaccine Injury Act preempts such claims made in state court.

I, of course, felt very sorry that the victim and her family, all of whom had to suffer for 18 years by that point just to be told they had no recourse in state court to hold a vaccine manufacturer accountable, but what about trying to seek some redress in this Vaccine Court mentioned? Further down the article further explained:

Millions of infant vaccines are safely administered each year throughout the United States. But government officials acknowledge that a small percentage of infants experience a severe negative reaction from a vaccine. In some cases the reaction can be fatal.

Faced with open-ended damages from lawsuits filed on behalf of those who suffer severe reactions from vaccines, drug manufacturers considered avoiding the vaccine market altogether.

In passing the National Childhood Vaccine Injury Act, Congress sought to strike a balance that would protect vaccine manufacturers from open-ended liability from private lawsuits while also creating a special fund to compensate those who suffer side effects from vaccines.

Roughly 100 to 200 claims for compensation are submitted each year to a special vaccine court. To date, the compensation fund has paid out $1.8 billion to 2,500 petitioners. The average award is about $750,000.

From here, I thought I’d see if any part of the pertinent Supreme Court decision explained this more and in plain English, so I just Googled it.

Here is the first paragraph of that decision:

SC Paragraph

If I’m reading the “no-fault compensation program” part correctly (I’m not a lawyer), it sounds like this vaccine court (under the HHS umbrella) can’t officially admit fault and won’t assign any blame to the vaccine makers they’re trying to shield but they’ll pay out injury claims, according to a prescribed vaccine injury table.

If one’s child or an adult had different vaccinations and their specific adverse reactions match within the prescribed time frame, it’s presumed that the vaccine caused the reaction and a capped but specified amount will be paid out for the injury (up to a maximum of $250,000 per death) plus some compensation for medical, rehabilitation, counseling, special education, lost wages, and attorney fees (attorney fees reimbursed regardless of win or loss), all within 240 days.  There are no peer juries in these vaccine court cases and the judge is literally called “Special Master” (check out the qualifications to become one).

Although it’s a $0.75 per dose excise tax levied on vaccine makers that is used to fund the vaccine court, it’s ultimately the taxpayers who wind up paying to legally immunize vaccine makers in this “structural quid quo pro” setup.

The flu vaccine is listed in this table, but it doesn’t specify what specific adverse reactions or time frame qualifies one for compensation claims.  Since it wasn’t clear what all that meant, I decided to do a Google search on “vaccine court flu injuries” and the first hit returned was by a Dr. Sherri Tenpenny, DO, where she had 60 embedded links to various vaccine court judgments linked to flu vaccines from JAN12 through AUG12.  So I started reading a few of these documents to obtain a flavor of what exactly goes on in these courts.

Sure enough, HHS (the respondent) always denies that the flu vaccine caused any injury, including death, but in these selected 60 cases over 8 months, they usually pay out something–GBS frequently occurs and and death doesn’t always pay out the most in terms of lump sums awarded, interestingly enough.  I have to say, these were some pretty interesting documents to read and they’re not very long or overly technical.

How Harmful Are Flu Vaccines: Tough to Say

Given this long, legally blessed marriage between government (HHS–parent agency for FDA and CDC) and vaccine makers, it’s tough to find any official evidence that flu vaccines cause any harm for obvious reasons, at least since this 1986 vaccine law was passed and implemented.  Just remember though that absence of evidence is not evidence of absence.  As a patient and potential consumer of flu vaccines, it’s good to know that if I were to suffer serious harm from it, my only potential recourse is to roll the dice in this federal vaccine court before a “special master” that can’t and will never admit that any vaccines cause any harm.

Of course, knowing this you have to ask yourself if any vaccine, specifically the flu vaccine, is advertised as totally or mostly harmless in exchange for a small benefit, why would vaccine makers require such strong legal immunity by the government and ultimately paid for at taxpayer expense?  What incentive in this quid quo pro arrangement is there for either vaccine manufacturers or the HHS (and its subsidiary agencies) to really make effectiveness and safety top concerns when the 1986 law that was recently upheld was designed to protect vaccine maker bottom lines?

In the interest of fully informed consent, perhaps vaccines in general should clearly convey such legal warnings in advance?

Category: Uncategorized
  • Darren Browy says:

    During the mid-20th century, identification of influenza subtypes became possible, allowing accurate diagnosis of transmission to humans. Since then, only 50 such transmissions have been confirmed. These strains of swine flu rarely pass from human to human. -::’

    Until next time <http://www.healthmedicine.co/

    07/06/2013 at 4:05 AM
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