Vaccine makers: still granted immunity.
March 01, 2011

Last week, the Supreme Court voted 6-2 to uphold the National Childhood Vaccine Injury Act of 1986 (NCVIA).  The NCVIA requires that individuals claiming vaccine-related injuries file their cases through a federal vaccine court (the so-called “Vaccine Program”).  The Vaccine Program is a no-fault compensation system, which means that if a person feels that a vaccination resulted in injury or death, they can apply to the federal government for monetary reparations.  They cannot file a lawsuit against the drug company responsible for the vaccination and typical routes of civil litigation are not available to them.  The NCVIA also protects drug companies from some vaccination-related lawsuits.

Of course, like anything, the Vaccine Program is not perfect.  The case that came before the Supreme Court was based on a parental claim that after being administered a specific vaccination, a healthy baby girl was afflicted by seizures and other side effects.  The lawsuit claims that she will need care for the rest of her life as a result of the vaccination.  The Vaccine Program denied monetary compensation for the parents’ claim.  The drug company, for the record, also refutes their claim that their daughter’s health problems are related to the vaccine.

The drug company also leveraged an interesting point: if these parents won their case, it could feasibly open the floodgates at the state level to a massive number of vaccination-related lawsuits against the vaccine makers.  Naturally, that could cause significant supply problems for childhood vaccines.

I’ll be honest: most vaccine news flutters right past me, but this one caught my eye because, well, I agree with the ruling.  I can’t contribute much to the debate about whether it is better to vaccinate or not and I can’t contribute much to the discussion about what the science says about potential side effects, but I can weigh in on this.  I agree with the new ruling because I feel that it is wrong for us to allow the supply of childhood vaccines to be threatened by civil litigation.

What do you think?  Should parents be able to sue vaccine makers directly?

WSJournal article by Ashby Jones | CNN article by Bill Mears

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  1. By Jessica Johnston on March 01, 2011

    I definitely feel that people should be able to file a lawsuit against the manufacturers of vaccines. Maybe then there would be adequate studies by third parties and vaccine manufacturers would begin producing safer vaccines.
    Look for articles that talk about the problems that have been found years later with vaccines that were deemed “safe and healthy” at the time they were given!
    The preservatives, additives and schedules of vaccine’s today are not as safe as the government and the profiting drug companies would have us believe.

  2. By Stephanie on March 01, 2011

    I agree with the ruling also.  If you “open the floodgates” as you say, this would not only lead to supply issues for these vaccines, but the cost of these would make them unattainable for so many.

  3. By on March 01, 2011

    I agree with the ruling. The vaccines DO have adverse reactions this is a known thing. But the adverse reactions happen in a small number of people.

    Compare that to the effects of actually getting the disease though. Or the effects of an epidemic of the disease.

    Vaccines aren’t perfect, but they are MUCH MUCH better than what happens when we don’t have a vaccine.

  4. By Stephanie @ Confessions of a Trophy Wife on March 01, 2011

    I have mixed feelings on this issue.  By not allowing parents to sue the vaccine makers these cases are kept very quiet (are they public record?  I don’t know.  But either way, they’re not as publicized as a real court hearing would be and I’m sure that people would be interested into how these things play out) and the manufacturers can essentially operate outside of the standard laws and judicial system of America.  That doesn’t seem to be fair or make much sense although I do understand some of why it has to be this way.  Public opinion is very important to the issue of vaccines. 

    I agree, you do have to consider the fact that parent’s suing vaccine manufacturers could lead to production/supply issues.  As far as cost, it’s an interesting thing, vaccine manufacturers actually already build in potential monetary compensation to the cost of their vaccines.  I can’t remember what the actual amount is, but a signification portion of the cost of the vaccine goes toward their fund that they pay out to families who have been harmed. 

    I also think it’s hard to hold a manufacturer responsible for negative reactions when they warn you ahead of time that these reactions can occur.  I think a lot of people might not take notice of these potential side effects, but that’s not the manufacturers fault.  For example, just prior to a vaccine, the nurse will hand you a sheet that says MMR can cause: fever, rash, glandular swelling, seizure, pain and stiffness in joints, blood clotting problems, “serious allergic reaction” (which is anyone’s guess what that actually encompasses), deafness, long term seizures, coma, or lowered conciousness, permenant brain damage - I’m taking this from a fact sheet my doctor gave to me today. 

    This sheet, is the manufacturer making sure that they inform you of the risks associated with a given vaccine.  If any of these things happen, they’re not really going to be held responsible.  That’s why, in my opinion at least, it’s important that parents look at the benefits and risks BEFORE the actual appointment comes up.  It’s really too hard to do it once you’re trying to wrangle a baby in a tiny exam room :)

    So, basically my opinon is kind of all over the place on this issue.  I don’t love the way things are done, but I definitely don’t have a suggestion on how to make it better.  I do hope that one day (soon!) they have safer vaccines and people won’t have to deal with negative effects.  I really feel for these families and the challenges they are facing.

  5. By on March 01, 2011

    Adverse reactions are public record. Just go here:

  6. By Stephanie @ Confessions of a Trophy Wife on March 01, 2011

    I was referencing more along the lines of rulings and settlements and that sort of thing.

  7. By Sheila on March 02, 2011

    I strongly disagree with the ruling.  I don’t think it’s going to keep manufacturers from supplying plenty of vaccines; it might hurt their overhead slightly (perhaps enough to make a bit more testing a good financial choice?) but it won’t put them out of business.  Pharmaceuticals are THE most profitable industry in the US.  That’s not going to change just by allowing lawsuits, IMO.

    Many times, vaccines have been released and then recalled later because of side effects.  Why weren’t they tested enough to discover those side effects beforehand?  Oh yeah—because it doesn’t hurt the manufacturer at all to cut corners: they can’t be sued.  I think allowing lawsuits will make vaccines safer.

    If it’s fair to protect vaccine manufacturers from suits, we definitely shouldn’t let people sue their doctors, either.  It drives the cost of healthcare up and makes it less accessible, and after all, doctors do have you sign a release!  The reason we allow lawsuits against doctors is because of negligence.  Perhaps we should be stricter about what lawsuits are granted, but negligence happens and I think it’s perfectly valid to sue a negligent doctor or vaccine manufacturer.  They should be taking EVERY precaution to keep our kids safe, and they just aren’t.

  8. By Sarah Christensen on March 02, 2011

    Sheila and Jessica Johnston - I do tend to agree with both of you about the studies.  Vacinnes should be more widely studied and there should be more information about them and their possible side effects made open to the public.

    I still think it’s a bad idea to do anything that can threaten the supply of vaccines, though.  We have long known, all of us, that not every vaccine is safe for every person.  We also know that the reason universal innoculation is encouraged is because some people cannot be vaccinated or cannot build the necessary immunities to a disease.  In fact, we chose to vaccinate in large part because we believe it’s a social responsibility.  We both tend to believe that, as someone else said above, the side effects limited to individuals are a better situation than the effects of one of those diseases or, worse, of an epidemic of one of those diseases.  We don’t like accepting the potential consequences, but Donald and I were talking about it and we couldn’t really think of a better solution.  Every time we came up with something, we could think of significant drawbacks.  I’m not a big fan of pharmaceutical set-up the way it is, especially as it relates to childhood vaccines, but I can’t really complain if I can’t come up with better ideas.

    I guess the real question is: are there any other ideas about vaccination control and litigation that would make the vaccines safer and that would flood the public with more information about them?

  9. By on March 02, 2011

    Such a touchy subject really. I know when I was pregnant, I did some research on vaccines after talking to a friend who said should would not be vaccinating and everything I read really pushed me in the direction of vaccinating. We love to travel, the ‘public duty’ (as you basically said) and the risk of not doing it vs doing it. My husband thought I was insane for even questioning it.

    I know that many offices cram so many vaccines together. Perhaps a solution would be for companies to encourage spreading them out over time. But that means more visits that parents won’t keep up with, more visits for insurance companies to cover and even more crowded doctors offices… etc. And when many parents already seem to struggle keeping up with well visits…

    I think flooding the public with knowledge could potentially lead to more problems. Money hungry people coming out of the wood works for their chance to sue (even if it’s the government - not the companies)... or people who won’t take the time to educate themselves on the issue just using it as an excuse to not vaccinate or just not go to doctor’s visits. It’s sad to think that our fellow public wouldn’t want to properly educate themselves… but the sad truth is the vast majority don’t. 

    I personally agree with the ruling.

  10. By Sarah Christensen on March 02, 2011

    Alicia - We thought about that too - spacing vaccinations out over time seems like a pretty reasonable compromise for most families.  But the only way we could think of that it would work and still keep the diseases at bay would be to make it easier for families to visit the doctor AND to encourage adults to stay up-to-date on boosters.

  11. By on March 02, 2011

    I am a bit late commenting here, but I was reading through the post and then the comments and I was compelled to add my two cents ...
    First I would like to preface: I am in no way advocating that we have a perfect system.  In fact, I believe quite the contrary.  But I do think this idea that ‘more testing’ is needed is a bit problematic.  The truth is, at least, the truth as I understand it to be, is that vaccines are tested quite rigorously using the highest standard of scientific testing we have available to us: the randomized controlled trial.  The problem is that these trials take a lot of time (decades and decades and decades) and a difficult decision has to be made - wait for more conclusive results on a vaccine that is seemingly safe and deny the public the opportunity to collectively protect itself from illness, or release the vaccine somewhat prematurely, knowing and recording those very real risks and allow the public to make the decision.  As has been mentioned, a vaccination is not usually administered without some acknowledgment of the risks beforehand.  Are the doctors and big, bad pharma companies just trying to cover their asses?  Absolutely.  But I think the truth of the matter is that they are also (and arguably more importantly?) trying to communicate important information.  Important information, as Stephanie mentioned, that outlines possible adverse reactions and warns of complications, however unlikely.
    Expanding one’s right to sue hasn’t really done a whole lot to improve medical care, and I don’t think there is reason to believe it would in any way assist in the development of ‘better, safer’ vaccines.
    Thanks for a thought provoking post Sarah!

  12. By on March 02, 2011

    I thank God that all four of my children were vacinated and nothing awful resulted from it. Had something awful happened, I would have regretted giving them those shots. I lucked out. So I understand a parent wanting to sue when they had a perfectly normal, healthy child and he/she changed (autism) or became a child with medical issues right after having the shots. It all depends on which chair you land in.

  13. By Danielle @LifeBeyondTheBump on March 03, 2011

    I can see the view of keeping vaccine makers accountable for their actions, but I think there is a deeper problem with vaccines and healthcare in general.  Our healthcare professionals aren’t giving us the information we are entitled to.

    I think its time we, as patients, make conscious decisions about our healthcare.  We need to stop blindly following medical professionals and really think about what they are recommending for us.  Parents should research the vaccinations being suggested for their children and weigh out the pros and cons of getting them.  Of course each family has different values; some may decide to avoid vaccines, some may decide to have the recommended ones.  We need to make a conscious decision that is best for our situation instead of just blindly following doctors and trying to find someone else to blame when something goes wrong.

  14. By on March 05, 2011

    Im on both sides of this (little late here). Ari had an adverse reaction to the dtap (diptheria, pertussis, and tetanus), her reaction stemed from the pertussis part of the shot, her reaction was 3 days of unconsolable crying, with is a moderate reaction, and in the same category as seizures, and now makes her unable to ever have the shot again, because next time, her reaction could be, and more than likely WOULD be, very serious. I dont want her getting the shot, but I dont want her getting whooping cough either, so im in a catch 22.

    If something more serious happend, or i had just brushed off her constant cries and screams as normal cranky and being fussy due to the shot, which is what ive learned a lot of parents do, because they do not know better (saddly), and she got this shot again, it could have killed her. and you better believe, id go for blood if it happend.

    Its like saying… you drive a car, the breaks fail, and its the car makers fault, they missed something, you cant sue? you know driving is dangerous, your aware things COULD happen, but if you now have a serious injury, or you pass, and your family can not sue? Where are YOUR rights in this? People arent going to stop buying cars, just like people arent going to stop getting vaccinations for their children (some would… but most will not). People should be held accountable, more testing certainly needs to be done, who cares how long it takes, its childrens lives! 

    if something happend to Ari, id lose my mind, and like i said Id go for blood. People are already refusing to vaccinate, because there isnt enough testing, and we dont know every single reaction that can be caused by very single shot, and we should know… its our right to know. how can be make the best possible choice for our children, if we do not have all of the facts? and we wont have all the facts until THEY do and saddly… they do not.

  15. By on March 18, 2011

    Im a new reader so this is late. However i have been researching this a lot bc im about to have my second child. My first is twenty one months and is fully vaccinated. It is important to note that there isn’t a real choice when vaccinating. Someone mentioned it’s the parents fault for not reading the risks of vaccines. However, although every state differs most require vaccines for school registration. Most states offer a way around this if its for religious or personal belief. However ALL vaccines have to be denied in most instances or the waiver won’t be granted. I think some vaccines are worth the risk and some are not. Particularly heb b which since its administered at birth i have been researching the most. Why does my child need to be vaccinated against an std (i know there are other ways to get it but usually its through sex or drug use) at birth. I know on a policy national level its bc not all moms have prenantal care and they dont want it passing at birth. However i know i dont have hep b. The other reason given for the hep vaccine being given so early is bc kids fall out if the healthcare system before they are sexually active. They dont even know how long the protection will last so these reasons to me are not strong enough to have my newborn receive a bunch of unneccessary chemicals that could harm him. I want to be able to choose which vaccines I want but don’t have that choice if I want my children to attend daycare and school. As a working mom who lives far away from family this doesn’t leave a lot of choice. I need my kids in some kind of daycare that I can trust which as of yet since I don’t feel I can trust an individual is a licensed daycare which requires all shots. I know the legal system is not perfect, I know that lawyers are often only in it for the money. However, lawsuits serve as a check against unethical practices and big companies need this more than anyone. Nit enough studies are done on vaccines, not enough information is given, and while I appreciate the greater good my number one concern is my child. I don’t agree with the decision. I would never want my child to be a test subject for any drug and lawsuits help ensure that when drugs aren’t properly tested before they are released there are consequences. I also think more people would not opt out if there was appropriate recourse for harm caused by vaccines.





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