Tuesday, October 5, 2010

Bruesewitz v. Wyeth : Coming Next Week

Flickr Photo by dbking
A week from today, the US Supreme Court is going to hear arguments in Bruesewitz v. Wyeth, a case about vaccine injury. At issue in this case is whether vaccine manufacturers can be directly sued in a normal court for injuries that are caused by their products.

In you are interested in the details of the case or actual filing in the case, I recommend this excellent resource which is maintained by SCOTUS blog.

As matters stand now, almost all claims of vaccine injuries must be filed with the National Vaccine Injury Compensation Program, more commonly known as vaccine court. This is a special venue that was created by the National Childhood Vaccine Injury Act of 1986 and was meant to be a no-fault, swift, flexible, and less adversarial alternative to the traditional court system. But this venue is not a the traditional court system and the rules it operates under can be quite different.

When you submit a claim with this program, the vaccine manufacturer is not the defendant (or respondent) but rather the federal government. And if you win your claim, it is not the vaccine manufacturers that pays for the damages but rather other people like you. Let me explain that last part as it can be a little confusing.  Every time a vaccine is administered, a surcharge is added to the cost of the vaccine and is paid by whoever is paying the medical bill (such as an insurance company). These surcharges are then collected by the government and any awards made by the vaccine compensation program are paid using these funds.

Or to put this in simple terms, a vaccine manufacturer cannot be sued for harm caused by their product nor are they financially liable for damages. Regardless of where you stand on the possible link between autism and vaccines, I think we can all agree that absolving an entire industry of liability is not the best of ideas and is just asking for problems.

There might have been valid reasons for setting up this situation back in 1986 when the supply of vaccines were very much in doubt. Back then, vaccine manufacturers were facing a large number of law suits (although very few of them successful) and were threatening to pull out of the market entirely. Fast forward to today and the vaccine market is considered a growth market, with billions in dollars of revenue (e.g. Merck alone booked almost 1.4 billion dollars in revenue from the sale of vaccines in 2009).

When you file a claim with the so-called vaccine court, your claim is handled in several different ways, depending on the exact nature of the injury. If the injury is a commonly accepted one (i.e table injury) then your claim will be awarded quickly. If it is not, your case is heard by a special master and you have to prove that the vaccine caused the injury.

After following the the doings of the vaccine court for several years, I think I can safely say that the program is not living up to what it was supposed to be. Rather than the program being a swift alternative to the traditional courts, claims filed with this program can take many years to resolve - even for simple claims. And, as anyone who followed the autism omnibus proceedings can tell you, the process in the court is anything but "less adversarial".

This so-called court also seems to have a major aversion to using the word "autism" and vaccine together.  If you claim that your child has a vaccine injury as well as autism, the chance of you winning your claim is almost non-existent.

Even worse, in the few cases were the court has awarded damages when autism is involved, they have gone well out of their way to avoid making it seems like there could be any possible relation. For example, in the Hannah Polling case, the documents make reference to "features of autism" rather than autism directly. And even more telling, in the case of Bailey Banks, the special master actually created a new condition - "non-autistic" PDD-NOS.

 For anyone who has half a brain and understands the terminology involved, that phrase is like saying "non-wet" water or a non-automobile car.  PDD-NOS is, by definition, a form of autism and you cannot simply say that it isn't autism because we happen to know what caused it.

Just as a side note, while I don't think that vaccines leading to autism is all that common, if you don't think it is possible at all, go look at the Hannah Poling case.  Done?  Ok, save the "yes, buts" and just accept the fact that it can happen.  Even if we are only talking about this happening to 0.1 % of all children with autism, that would still be 40 children per year in this country alone.

The vaccine compensation program is operating without much oversight from the traditional court system and is basically being run by the same governmental organizations that are responsible for promoting vaccine use.  This arrangement gives the phrase "conflict of interest" a whole new meaning.  And, if you thing that the Special Master made any factual errors in the case or didn't consider the evidence properly, you are pretty much out of luck. As the US Court of Appeals for the Federal Circuit said in their recent ruling in the Cedillo case (starting on page 10)-
We review the Special Master’s factual findings using an “arbitrary or capricious” standard. We “do not sit to reweigh the evidence. [If] the Special Master’s conclusion [is] based on evidence in the record that [is] not wholly implausible, we are compelled to uphold that finding as not being arbitrary or capricious.” Our role is not to “second guess the Special Master[’]s fact-intensive conclusions” particularly in cases “in which the medical evidence of causation is in dispute.”
It will be interesting to see where this case goes. I suspect that the Supreme Court is going to uphold how the law is currently being interpreted, which means that it would be up to Congress to make any needed changes in how the program operates.

Time will tell.


  1. You and I seem both to agree that a simplistic genetic explanation of autism is not sufficient to fully describe the phenomenon as we see it.

    However I do wonder where you are coming from.

    Perhaps you might be gracious enough to answer this question.

    Are you a vaccine damage acolyte?

  2. The author said:
    Are you a vaccine damage acolyte?

    Right back at ya!
    Are you a vaccine damage denier?

  3. I happen to know the facts, that is all, neither mercury or the viral component of the MMR vaccination have the capacity to do what is purported of them, that is not to say that vaccination does not have it's repercussions, it is a matter of proportionality and risk.

    For some people sunlight is very risky, for most it is essential, now go figure.

    To assume that genetics is not a whole explanation for autism does not assume that some of the wilder and wackier explanations (Electricity Pylons, and circumcision for two) are.

    The mercurian and mutually logically exclusive measles remnant therists are truly up a pylon there.

    To state the truth cannot be denial except in the eyes of the ignorant and uniformed.

  4. How can you know all the facts if you don't have all of the evidence? That is both narcissistic and unscientific. It cannot be the truth in absense of all of the evidence. That is simple logic. Your opinion is that vaccines, specifically the Thimerosal and MMR hypotheses, cannot cause autism (at least, that is what I inferred from your comment). All it takes is a single incident of a vaccine injury that results in autism to invalidate your theory.

  5. I think the question of whether vaccines can trigger autism is a complex one with no good answers.

    On the one hand, I firmly believe that there are some few children that regress into autism as a direct consequence of receiving one or more vaccinations. But, on the other, I don't think there is any good evidence that one specific component of a vaccine is what can make that happen.

    The important questions, to me at least, are how often does a child regress as a result of receiving a shot and what is going on when it happens? I think that vaccines plus something else going on at the same time (or some underlying condition) can cause regressions, but I don't think that vaccines alone could do so. Still, the regression might not happen without the added hit of a vaccine.

    To use an analogy, think of it as a person balancing in a wave pool. A single small wave would be highly unlikely to knock the person over. But, if that same person had just been hit with several other, larger waves and had not recovered their balance yet, the smaller wave could well be the final blow that knocks them off their feet. If that smaller wave comes just a few brief moments later it would not be enough, but because of exactly when it hits, it is enough and the person falls over.

    None of the research that has been done would have detected this happening. And, most importantly, most of the research that has been done with the explicit purpose of exonerating vaccines - which is a bad way of conducting research.

    Now, whether you think that these ideas make me a vaccine damage acolyte is entirely up to you. I prefer to think of it as keeping an open mind and following what science has actually demonstrated rather that believing the party line.

  6. ill continue my research for my daughter. here's another article i found on the flu shot


  7. MJ..I'm with you 100% on your perspective re:vaccines and rocking the boat. I had the "great opportunity" to have done vaccine research 20 years ago, before there was this much heat on the subject. My eldest got shots up until she was two...but by the time the youngest came around (pre-stroke), I had enough information to choose to not expose her to the risks. My concern has always been about the number and dosage of vaccines given to babies with undevelopped immune systems. It's too much, too soon, especially if the foetus was exposed to less than ideal circumstances. Furthermore, there are problems with the quality of the vaccines at administration....poor handling, poor dosing, expirations, etc. Also...a vaccine does not follow the normal "pathology" of any given disease. No one gets MMR all a once or DPT all at once. Vaccines bypass and/or upset the body's normal, healthy immune response. For infants, that's a lot to ask a little body to manage! Too many people do not understand that MOST people who makes claims about vaccines being unsafe, are not against vaccines per se, but about the vaccine schedule in North America. We need fewer vaccines, smaller doses, at older ages. Last, but not least, homeopathic/naturopathic science has a long and successful history in dealing with these illnesses and can address immune boosting with nosodes and the like.