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Drive Thru Medicine, SIRVA, and the Vaccine Court

Drive thru fluBy Wayne Rohde and Louis Conte

A continuing series examining the NVICP aka The Vaccine Court

In recent weeks, you might have seen and read several articles posted by attorneys that practice in the NVICP, discussing the compensation awards they achieved for their client, the vaccine injured petitioner.  They all have a common theme. Not the fact they are winning some petitions, but rather the actual type of vaccine injury.

In the November 2014 GAO Report presented to Congress on the National Vaccine Injury Compensation Program (NVICP), the report pointed out one indisputable fact that the Program is no longer about childhood vaccine injuries.  It is a program with the majority of petitions filed from adults, nearly 80%.  And the vast majority of those petitions are from injuries as the result of the influenza vaccine.  The alarming trends of injuries from the influenza vaccine are Guillain-Barré Syndrome(GBS) and Shoulder Injury Related to Vaccine Administration, (SIRVA).

We are familiar with GBS and the effects on many people around the globe, similar to polio.  There is even credible studies that show what we know today as GBS was often diagnosed as polio 60-80 years ago.  GBS emerged on the national scene back for many people back in 1976 when the CDC lied to the American public and to Congress about the pending epidemic of Swine Flu.  Because of the large immobilization to vaccinate people against the Swine Flu, GBS became a horrible injury for many people nationwide.

Guillain-Barré syndrome can affect anybody. It can strike at any age and both sexes are equally prone to the disorder. The syndrome is rare, however, afflicting only about one person in 100,000. Usually Guillain-Barré occurs a few days or weeks after the patient has had symptoms of a respiratory or gastrointestinal viral infection. Occasionally surgery will trigger the syndrome. In rare instances vaccinations may increase the risk of GBS.”

GBS is a vaccine injury and the cases compensated by the NVICP show this clearly.

But what about SIRVA? It can be described as “shoulder pain that is a common transient side-effect of vaccination. Infrequently, patients can develop prolonged shoulder pain and dysfunction following vaccination. Common clinical characteristics include absence of a history of prior shoulder dysfunction, previous exposure to vaccine administered, rapid onset of pain, and limited range of motion. The proposed mechanism of injury is the unintentional injection of antigenic material into synovial tissues resulting in an immune-mediated inflammatory reaction. Careful consideration should be given to appropriate injection technique when administering intramuscular vaccinations to reduce the risk of shoulder injury.” [i]

The vaccine-related over-penetration that likely led to SIRVA could have been prevented by refining the Centers for Disease Control and Prevention's current injection guidelines.[ii]

Basically we have a medical condition caused by a flu shot being injected too high on the arm.  Why is this happening?  Let’s go back to the NVICP.  It is a relatively new injury being adjudicated by the program.  Ok, if it is new, what is the reason why we are seeing so many petitions filed in the program?  Is it a new variation of the flu vaccine?  The answer is no.

The Program as it stands today is doing an exceptional job handing all these influenza petitions and we are seeing a major uptick in the numbers.  Roughly 25% more petitions will be filed as forecasted by HHS compared to 4 years ago.  And the long term forecast is for large increases each year.  The Court under the direction of Chief Special Master Denise Vowell has established a Special Processing Unit to handle the influenza petitions with great expediency.  These petitions are fast tracked.  Most of these petitions will take approximately 1 year to complete and the injured party receiving compensation.  This is compared to the 3-4 year journey for other petitions.

But it still does not answer why we are seeing a large influx of influenza petitions claiming SIRVA.  The answer lies in the timing of the injuries.  Most of these petitions filed with vaccination dates in 2013 and 2014.  What else have we seen change in the landscape of flu vaccinations during this time period?  The answer is amazing.

Most of these SIRVA injuries occur because of improperly trained clinicians or personnel administering the vaccine.  And most of them are from retail pharmacies and mobile clinics.  Having read a few hundred case decisions or rulings of entitlement associated with the influenza vaccine, the common theme is the vaccine was administered at a Walgreens, CVS, or other retail pharmacy, or some of these mobile clinics.  The aggressive marketing to vaccinate everyone with the influenza vaccine has resulted in many people suffering from poor training of vaccine administration.

In Minnesota, during the 2014 legislative session, a bill was introduced to allow dentists to administer the influenza vaccine.  The thinking was to get more people vaccinated.  Can you imagine getting your flu shot while your dentist works on your tooth or the hygienist cleans your teeth?

The SIRVA injury is nothing to write off.  It is serious and often very painful to the injured party.  Think about losing the ability to use of one of your arms, either temporarily or in some instances, a more permanent loss of the use of your arm.

This type of injury begs the question whether you can sue the vaccine manufacturer for damages or the doctor or clinician for damages as the result of the vaccination, can you seek a remedy against a medical practitioner who injected a vaccine without proper training, resulting in a debilitating injury, not related to the actual vaccine?  There has been some discussion by a few attorneys in the Vaccine Bar about this very issue.  The NVICP does not shield improper training from liability. 

The Secretary of HHS, in coordination with the CDC and IOM, has recognized GBS and SIRVA as known injuries and is working to establish it in the NVICP as a table injury.  Currently, these types of injuries are treated as Off-Table or causation injuries.  Most of these injury petitions are compensated.  However a few have been dismissed, mainly due to incomplete medical records such as vaccination dates or the lack of medical treatment. 

The cost to the petitioner before filing a petition for compensation can be very high.  Several doctor appointments, probably paid by insurance.  The very costly MRI expense, hopefully paid by insurance.  And it might require surgery to fix the injury.  But if you need the use of your arm for work (think musicians, doctors, office staff, parent of a special needs child, and the list goes on and on), that loss is not paid by insurance.

Many people who have developed SIRVA from retail pharmacies or mobile clinics have contacted these companies directly.  And many have received direct compensation for their injury.  However, the compensation is rather small, usually in the $10,000 - $50,000 range.  Yet the injured party is not informed about the NVICP or their right to file for compensation.  Even more troubling is the fact that many of the injured do not receive proper medical records or other documentation proving receipt of the vaccination. 

You can assume that this makes the Secretary of HHS and DOJ civil torts division very nervous.  And sooner or later, there will be communication, if not already, to corporate legal departments representing these retail pharmacies to discontinue this practice.   Any kink in the shield of legal immunity of vaccines has the attention of our federal government and the pharmaceutical industry.  SIRVA is not a disease but the result of improper administration of a vaccine. 

The point here is with the big push by the CDC, HHS, the media, and now retail pharmacies and mobile clinics promoting flu shots, it is really buyer beware.  And allowing these businesses to administer more than just an influenza vaccine, this is clearly a big problem for the Program.  If you must, don’t receive a vaccination in the drive thru window retail outlet or sitting in a chair at your neighborhood grocery store.  And by the way, those pharmacies push the shingles vaccine.  That vaccine is not covered by the NVICP, thus you are really on your own.

Comments

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nadean

I think all vaccines should be on there. If they cause a problem why not?

christins

Any updates on the vaccine ppv23? Will it ever be covered?I revived the vaccine over year and still have shoulder problems. Never had shoulder problem untill I received the ppv23 vaccine

christins

What you do if you have injury from the ppv23 vaccine? Why is it not covered?

Howard

This is a very constructive thread. The system is not working as intended. Is it better than a torts approach? Probably. But far too much money is spent on attorney's fees and far too many petitioner's wait far too long for a settlement that could have been settled out of the gate. The SPU is an acknowledgment of that defect and is a step forward in my opinion.

Howard Gold
http://www.usvaccineinjurylawyer.com

Shell Tzorfas

http://spiritsciencehealing.com/flu-flu-everywhere-shot-spare/

Wayne Rohde

@Cassandra There are two popular vaccines filed in the program that are being "thrown out" due to lack of jurisdiction. Meaning, the vaccine is not covered by the program. The shingles vaccine (Zostavax) and one of the pneumonia vaccines (polysaccharide - PPV23).

Theoretically one could bring a suit against the manufacturer for injuries. However, the burden is so high and costly to bring a suit.

Vicki Hill

This is the first I have heard about SIRVA. Last year I got a Tetanus booster...and it took 3 weeks for my shoulder to recover! I was shocked; I had never had a reaction to a vaccine before.

It might be helpful to get this word out more. Adults might have a different perspective on the subject of vaccine injury if they realized that they, too, are at risk of injury...not just young children. (I know, it shouldn't be that way, but....)

Cassandra

"And by the way, those pharmacies push the shingles vaccine. That vaccine is not covered by the NVICP, thus you are really on your own."

Doesn't this mean that they can be sued for injures caused by the shingles vaccine?

Betty Bona

@Wayne,
That Vaccine Court really is a Kangaroo Court! If an Article III court found, for instance, that the shingles vaccine increased the odds of autoimmune disease, and actually caused autoimmunity in the case before it, I still think this could be of benefit in the vaccine court, especially with the varicella vaccine. Then again, I'm sure the Special Masters would find a way to ignore such a decision or distinguish it since that seems to be their job description. I haven't noticed any impact following the Supreme Court's finding that vaccines are unavoidably unsafe. I'm becoming increasingly nervous that even an Article III court judge would feel the pull of a similar job description. I hate to be so cynical, but I'm afraid that's what the future holds.

Plagued

Speaking of NVIC, I recommend everyone with a child (or adult) who has a vaccine injury fill out a claim. You can still do it even if its past the 3 years that it seems to require. I did this for my son, becasue it is reasonable that I did not read the information that helped me realize that was what was wrong at the time it happened.

My point is, if I were the CDC, and this stuff DID come out, my first step would be to quietly compensate (on condition of silence ) everyone who filed a vaccine injury claim. If this ever does come out, then people are going to be accused of jumping on a bandwagon. Even though 90% of us didn't bother to file becasue we felt it was useless. So do it, if your child had a vaccine injury and you haven't made a VAERS complaint, file it.

Wayne Rohde

@Betty - your question regarding Article III court. This type of court consists of the US Supreme Court, Federal Circuit Court of Appeals, and Federal District Courts. Actions or decisions by an Article III court are binding to all courts in the US. Decisions by a Special Master in the NVICP or opinions issued by a judge from the Federal Court of Claims are not binding. However, there are some Special Masters that make a ruling in one type of case such as Hep B does not cause juvenile diabetes and then states in a totally different petition hearing that because of her ruling elsewhere, Gardasil cannot cause juvenile diabetes. Totally nonsense. And since there is not enough science to support the claim of diabetes, the petition is dismissed.

Birgit Calhoun

Have there been claims regarding certain combinations of vaccines and antibiotics? I am curious because certain vaccines contain antibiotics and others contain Thimerosal. Thimerosal and antibiotics have a synergistic effect. How about a synergistic effect of vaccines and Cipro (or any other synthetic antibiotic).

Betty Bona

@ Jeannette
It could be worth the uphill court battle for the pro-safe vaccine movement just because it might provide an opportunity to get around the evidentiary issues in the vaccine court. Once evidence is accepted by an Article III court, surely the Vaccine Court cannot continue to ignore it.

Jeannette Bishop

If a vaccine is not included in the NVICP does that technically mean the makers/administrators are not protected from liability, whatever uphill court battle might be ahead for the plaintiff?

beth johnson

A couple things come to my mind, reading this article. First, NVICP takes walking/talking/previously functioning adults far more seriously than our kids. It's harder to write off an adult who can easily give a first hand account of their injury.

The second is, does the uptick in flu vaccine injury compensation in pharmacies and mobile clinics parallel the general uptake in these settings? I suspect that the new sales locations, targeted and promoted now for some years, are rapidly expanding relative to traditional primary care office settings.

I would think a pharmacy customer who gets compensation directly from, say, CVS headquarters, would not be bound by gag clauses against the product like typical recipients are in Vaccine Court compensations. Maybe some victims would come forward about that. What percentage of Vaccine Court awards have gag clauses, is that even knowable?

I sure would like to know about whether or not those Special Masters get their own shots!

Wayne Rohde

Bob,

Great questions. Let me try to answer a couple of them. The Special Masters' focus is on the adjudicating of the petition. The Sec'y of HHS is charged with reviewing all petitions, the vaccines(s), and the related injuries. If the Sec'y of HHS was fulfilling her duties as Congress originally intended, medical outcome studies would be conducted to determine the safety of each vaccine, to identify certain risk groups that have an higher rate of adverse reactions. (Think Gardasil and those who use certain anti-depression meds or acne meds).
The Sec'y of HHS is also mandated by law to conduct reasonable public awareness of the Program.

So you can see that it is a big failure by the Sec'y of HHS.

As to your question about the shingles vaccine. There are several vaccines used today for adults that are not part of the program. Several of them are moving in a direction to be included. The two common vaccines, one for Shingles and the other is one for pneumonia. There are 2 pneumonia vaccines that are included and one that is not. The best way for anyone to know is to read the VIS statement prior to vaccination. If that vaccine is covered by the NVICP, the VIS statement will list the contact information of the NVICP in case of adverse reaction. The shingles vaccine VIS statement does not.

Jenny

To Bob: Regarding patterns of damage and whether special masters have any obligations to bring attention to them. I have no idea. It would be interesting to know if the special masters get flu shots after they are done with vaccine court, wouldn't it?

But we as individuals in the U.S. do have just a slight bit of ability to speculate about flu shot patterns. Since the southern hemisphere generally goes through the flu season before the U.S. I periodically search through the Australian flu season reports to see what strains are circulating, which ones are making people the sickest, and what vaccine situations are going on. That was how I discovered at the time that the CSL flu vaccine was causing some major issues.
Also, I looked at VAERS through Medalerts at the time, plugged in flu vaccine, and within the first 10 pages of results, I could see that among the most serious reactions listed and the ones showing lack of recovery, the CSL product was being listed time and time again. I told myself that if I was forced to get a flu shot, I would be wise to choose a different product than CSL's.
In the end, the CSL product was the one the Australian govt ended up un-recommending for kids due to seizures, if I recall correctly.

Bob Moffitt

Has a repeating "compensation award" for a particular vaccine adverse reaction .. such as .. GBS in flu vaccines .. ever resulted in the Special Master recommending the manufacturer take immediate action to identify what in that flu vaccine is mainly responsible for iniating GBS?

Do Special Masters have any legal (ethical?)responsibility to identify "which flu vaccines" are more likely to cause GBS .. so the public can be forewarned of the greater risk?

Indeed .. has ANY vaccine been made SAFER due to a Vaccine Court's decision to award compensation?

Or .. more likely .. does the Court simply move-on .. absent any recommendations the manufacturer actually has a responsibility to IMPROVE the SAFETY of their product .. thereby allowing the same adverse reactions to be suffered .. over and over again?

In my humble opinion .. in State or Federal Courts .. when a manufacturer is found responsible for any "unsafe product" that caused serious damages or injuries to unsuspecting consumers .. that PRODUCT is not going to be sold "as is" .. over and over again.

Consider .. if GM had an "auto court" fashioned on the example of the Vaccine Court .. instead of being held accountable in the State or Federal Courts .. they would never have reason to "recall" any car .. because .. the auto court's only concern would be deciding whether compensation is due INDIVIDUALS .. the hell with the safety of the GM's product that would remain a high risk for their "uninformed and unprotected" consumers.
---------------------------------
"And by the way, those pharmacies push the shingles vaccine. That vaccine is not covered by the NVICP, thus you are really on your own."
---------------------------------
I didn't think it possible the vaccine cartel could possibly have it any better than they already do .. but .. apparently I was wrong .. since .. the "SHINGLES vaccine is NOT COVERED BY THE NVICP".

How the hell did they manage to do this?

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