Supreme Court: No, You Can't Sue Drugmakers Over Vaccine Injury Claims

By Andrew Moseman | February 23, 2011 4:10 pm

If a vaccine injures a child, should the parents be allowed to sue in state court? That’s a question lawyers, vaccine makers, parents, and Congress have wrestled over for a quarter century. This week, the United States Supreme Court brought forth a ruling that keeps the status quo: No, you can’t.

The justices, voting 6-2, said a 1986 federal law preempts claims that a drugmaker should have sold a safer formulation of a vaccine. The law, designed to encourage vaccine production by limiting patient suits, channels most complaints into a company- financed no-fault system that offers limited but guaranteed payments for injuries shown to be caused by a product. [Bloomberg]

The case in question, which has been kicking around for nearly two decades, was brought by Russell and Robalee Bruesewitz on behalf of their daughter, Hannah. In 1992 she began experiencing seizures after receiving a diphtheria, pertussis and tetanus shot made by  Wyeth [part of Pfizer]. At the time, her parents tried to file a claim with that government-created system.

When a special Vaccine Court within the Court of Federal Claims ruled that her injuries couldn’t be linked with the vaccine, her parents tried to move the case to Pennsylvania state court. The Third Circuit Court of Appeals eventually ruled that the claim was pre-empted by federal law, a decision upheld by the Supreme Court. [Wall Street Journal]

Hannah has what’s called “residual seizure disorder.” Under the original setup of the government’s claims clearinghouse, she would have been covered no-questions-asked: Because of the difficulty in showing that a vaccine directly caused an injury, the government simply created a table of conditions that would be covered.

But in March 1995—a month before her family filed their claim—a special government advisory committee gave the injury table a radical overhaul. Under the new system, residual seizure disorder no longer qualified a child for compensation. Instead, Hannah’s family needed to prove that the vaccine caused her injury, and they were unable to do so. [Slate]

Justice Scalia and the other five voting in the majority cited the original intent of the 1986 law: It exists so that a flood of lawsuits—many perhaps frivolous—can’t create a public health crisis by impeding vaccine production.

Kathleen Sullivan, who represented Wyeth in the case before the court, told justices that ruling against the company could lead to thousands of lawsuits in which parents claim, for instance, that the mumps, measles and rubella vaccine played a role in their children’s autism. [Washington Post]

Justices Sotomayor and Ginsburg, however, argued in their dissent that by shielding drugmakers from lawsuits, what the government is actually doing is removing the pressure to create better and safer vaccines.

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Image: U.S. Supreme Court

CATEGORIZED UNDER: Health & Medicine
  • Daniel

    A vaccination shot resulting in seizures? Of course, happens all the time! When will they finally stop administering vaccination shots directly into the brain??

  • scribbler

    Who cares? With “Owe-bama” Care, soon all medical bills will be paid by the Fed. anyway….

  • coryy

    @ Daniel….Why the rancor over a side effect THAT IS LISTED ON THE GOVERNMENT FORM that you get when your kid GETS the shot? it’s a KNOWN side effect.

    Vaccines cause fevers. Fevers cause seizures in kids, OFTEN. All my kids had multiple fever induced seizures…it’s a misfiring of the signals that go to the brain to cause the fever. (Febrile seizure simplified: some of the signal that says, “fight infection, cause fever” goes a little afield and causes a seizure instead. By the time the kid has the fever, the seizure is over, it’s not the heat of the fever that causes them, it’s the immune response in the first place.) It’s a scary thing for a parent, but usually they outgrow them by age 5 or so. Usually the seizures stay fever-related only. But seizures predispose the brain to more seizures, so the case is not without foundation.

  • vickie98531

    How can the Government take away our rights? I am so sick of this type of thing going on and its ALWAYS in the interest of big business! I think its time for a Gov. re-do here!

    Anyone up for a movement?

  • Zachary

    The governments has a responsibility to ensure the greater public good. I’m not one to usually side with big business, particularly big pharma, but the mass amount frivolous lawsuits would have been catastrophic. Much like we see with malpractice insurance playing a large part in crippling healthcare.

  • tiddas

    WARNING: Zachary and Daniel are one person who works for BigPharm. It’s called a sockpuppet strategy.

    Big Pharm has never and will never be “crippled” by lawsuits.

    Actually, BigPharm lobbied for and had created a regulatory system that makes lawsuits almost impossible. The whole system is backwards. Instead of proving a product is safe before it is offered to the public, it is tested on the public to see what side effects occur and whether enough folks can get together and sue after the fact.

    Look at this case. 1992, child harmed. 1995, lawsuit filed. 2011, final opinion against harmed person.

    BigPharm crippled? Hah! Hah hah hah hah . . . . bank on that.

  • Gil

    @6 never heard of sockpuppets. Most forums I read call it astroturfing, but perhaps I’m mixing my neologisms.

    Anyhow, vaccines don’t tend to be too profitable, which is why we still make our flu vaccine in eggs, stupidly.

    If there wasn’t a protective program like this in place, we’d be either funding vaccines with tax money or up a creek without a paddle.

  • Vincent

    Okay, let’s see. Diptheria causes death, pertussis causes death, polio causes lifetime disfigurement and post polio syndrome, flu shots make you fevers for a day, tetanus shots can be painful for a while, but the options are worse, typhoid can kill, yellow fever can kill, and rubella can have severe life ling side effects. I have had just about every vaccine you can have with the exception of anthrax, but including rabies pre-exposure. I have had multiple smallpox vaccinations and well as meningitis vaccines. Many of them given at the same time. The worst I ever had was an afternoon of feeling crummy and the development of a pox on my arm. Being born in ’46, I received many of the vaccines that are given today, except I am sure those given today are much safer. Travels have required the other odd vaccines I have received as an adult with no significant reactions. I have seen people who have not had these shots and I’ll take my chances with a vaccine any day. Given all the crying and the placing blame by today’s parents on someone else, I really wonder how I have survived to 65 and am quite healthy. By not vaccinating children today, there is a greater risk to society of creating pockets of these illnesses that could have been created. Stop blaming the government and drug companies for everything.

  • coryy

    @Tiddas thanks for the heads up on that. I do feel for those parents…watching your kid turn blue during one seizure is bad enough, whatever the cause. Having a kid with multiple seizures would tear me to pieces.

    FWIW I have reported adverse vaccine effects that occurred with my oldest son,(not the seizures, other reactions–they gave you a list of things to watch for and a number to call to report them) using the gov’t approved reporting system to do so. That was 15 years ago though and I don’t know if it’s still available to parents. I understand the appearance of futility in doing so, but…it’s like voting democrat while married to a republican. You have to look at the big picture…at least you’re cancelling one vote out when you do your part, right? You try to use the system as it’s set up, first. Then you can document the system’s failure if it fails. I was under the impression that that is what these parents have done.
    It does seem that there should be a little more protection for the injured party and a litle less for pharma.

  • Seattle

    Parents have the right to make informed decisions and children need advocates that don’t accept the company line. Government and Big Pharma should not be the only source of information parents are allowed to consider when determining the safety and risks that vaccines pose to their children.

    Just like you can not force health coverage requiremnts on the public, it is no more constitutional to require children be injected with potentialy deadly viruses, with the justification that MOST don’t die or result in lifelong reduction in their quality of life.

    You can talk about public health all you want, but when it’s YOUR CHILD who is injured, with no hope of restitution or recourse, THEN you may speak to the benefits of mandated vaccinaions.

  • Zachary

    WARNING: I am not an astroturfer nor sockpuppet. It’s called having an opinion, and I’ve been on the boards here for awhile on a range of topics. The problem is we can never pinpoint cases where a child would have gotten sick when they don’t. We don’t know which children would have died of polio or measles when they do not contract the disease thanks to vaccination. However the rare instances when vaccinations cause complications are present, and much more visceral. It’s like the person who actually gets injured by the seat-belt; does that mean seat-belts are a bad idea? Do people who get injured by the seat-belts have the right to sue for large enough damages that provide incentive for car manufacturers to take them out of cars? I like the idea of the table of symptoms that get a set pay-out, and of course want rigorous controls on what gets put in, and in this case left off of, that list. Why were seizures removed?

  • Jake

    Most of you are missing the BIG point here. The govt tries to force kids to get vaccinated for everything and then when they suffer terrible side effects which admittedly include DEATH among numerous other conditions which are completely debilitating they say sorry, good luck with that. Whoever commented that vaccines aren’t all that profitable needs to give his head a shake, they wouldn’t be developing a vaccine for everything under the sun if it weren’t profitable. 1 in 1000 people who catch polio develops serious problems from it & the polio vaccine was contaminated with a cancer causing virus SV40 so generations of people got shot up with cancer to prevent maybe 1 in 10,000 or less from having paralytic polio. To Vincent; just because you’ve had some vaccines and are not dead yet is not an argument that they are safe or effective. Read the insert on the vaccine it’s admitted they cause death, seizures & auto-immune disorders and in fact every vaccine is capable of causing the disease it is supposed to protect against! I’m sick and tired of idiots spouting off about how the govt is trying to protect us and how we should all just shut up and get our flu-shots you morons need to learn how to read, all of the recent outbreaks of things like mumps, measles and rubella are among vaccinated children so either they don’t work or they are making kids sick. This isn’t even debatable, again it’s admitted so it’s the un-vaccinated people who should really be upset because the stupid idiots who insist on being shot up with the filthy garbage are creating new epidemics and endangering the rest of us otherwise healthy folks. Lastly every vaccine insert says this vaccine has not been tested for it’s carcinogenic potential which means they can’t be bothered to see if they cause cancer or not (I guess there’s no time because measles never sleep) So Vincent when you get cancer from all the cancer causing agents you’ve willingly injected into your body should you be denied treatment?

  • Jake

    To Coryy,
    seizure are a big deal it’s causing brain damage by depriving part of your brain from oxygen much like a heart attack causes a part of your heart muscle to die from lack of oxygen seizure can and do cause permanent damage and if all or any of your kids have had those reactions to vaccines then your kids have sensitive immune systems and should not be vaccinated. If you continue down this path each time the immune reaction in the brain may become more severe . I would suggest going the natural route & keep your kids and your self healthy by eating real food getting outside exercise and Vit D, many studies have shown it’s very tough to get sick or die from flu if you have enough Vit D.

    http://articles.mercola.com/sites/articles/archive/2011/02/18/leading-vaccine-doctor-states-cancer-linked-to-polio-vaccine.aspx

    http://www.nytimes.com/2007/10/11/health/11iht-polio.1.7847606.html

  • Zachary

    Actually it’s the un-vaccinated people who should be thanking the vaccinated, it’s called herd immunity. Are you really trying to make the case that vaccines cause more harm than good? That’s just a blatant disregard for the facts. Look at the number of deaths from the flu alone before and after vaccinations. Now compare them to the number of adverse reactions to the flu shot, it’s not even close.

  • Jake

    Hat Zachary did you see the links I posted?

    http://www.medicalnewstoday.com/articles/96913.php

    That one talks about how the flu shot targeted the wrong virus which means it didn’t offer any protection to the vast majority of those who received it. Even the WHO and CDC admit that flu shots don’t work very well if at all on the very young or the very old precisely the two groups who are in danger of dying from the flu. I also like the Seattle Times article because they blatantly lie and state that the nasal mist flu shot contains a “crippled” virus which cannot cause illness when the insert for the nasal flu shot says that it can. The real truth is it’s impossible to know the extent of the damage caused by vaccines because the auto-immune diseases & cancers they cause take yrs to develop. It’s also well known that the H1N1 flu shot caused hundreds of cases of narcolepsy and miscarriages & I personally know people who had severe adverse reactions to it & it was probably the least deadly flu in the human history.

  • Zachary

    I read the article, about one years shot not being a perfect match. Also, the article never claims that it provides no benefit, just less. Aso, the people who die, of most diseases, are young and old. That’s just a fact. So I guess until every year, the flu shot is perfect, and somehow manages to beef up the immune systems of infants and the elderly, vaccines are bad. You’re making the best the enemy of the good. Vaccinations are not perfect, neither are helmets, seat-belts, air-bags, or any other precautionary safety measure. They are however better than the alternative by far.

  • Zachary

    Also, you seriously need to link to the hundreds of cases of narcolepsy and miscarriages, because I’m not considering your anecdotal evidence of, “…personally know people who had severe adverse reactions…” as a legitimate reason to stop vaccinations.

  • coryy

    @ Jake…um, my kids have febrile seizures…if you’ll read my post you’ll see that I’ve seen my kids stop breathing due to them. I will never minimize that. However, febrile seizures are not a seizure disorder per se–they go away with age, and are not random, they are linked to illnesses only.

    Interesting side note: Medscape (free but requires registration) just posted an article linking combination vaccines to febrile seizures:

    http://www.medscape.com/viewarticle/738019

  • http://N/A allen

    back about 1955 bernice eddys was asked to do the quality controll experiments on the new ipv polio vaccine which had just passed “field trials” and just begun the mass polio vaccine program . she found the vaccines were causing tumors in the test animals and reported to alton oschner her boss . oschner reprimanded her and shut her up. oschner was heavily invested in the vaccine and covered up the carcinogenic potential of the vaccine. this was not realized again until about 1960 when sweet and hilleman also observed the virus and named it SV40 . millions had already been innoculated with this tumor causing virus .the problem was ordered cleared up, but, never was . at least till about year 2000 there was always intermittent bouts of vaccine contamination . NOW TELL ME WHO DO YOU REALLY TRUST. its ok for the FED to sue big pharma ,but NOT THOSE AFFLICTED BY VACCINE SICKNESSES?

  • Andria

    I agree. Drug makers should have more responsibilities in spending time to properly research vaccines before they rush them on the market for the business of money making. If not then they will put any “what’s it not” in their vaccines, and then call it safe. We all know, the Love of money is the root of all evil.
    Yes Dtap does cause seizures. The forms they give you in the clinic after your kid is vaccinated says that. I am in the medical field, so I am aware that with every seizure episode, there is some anoxia (lack of oxygen) going on in the brain, etc. Common sense should tell that when someone is having a seizure, they are not breathing for the lenght of the seizure. So, the point is the longer the seizure, the greater the lack of oxygen to the brain, and the greater the risk of brain damage. Don’t be fooled. With every seizure episode, there is some brain cells lost. My son recieved his 2 months shot (pentacel which contains the Dtap, Hip, Polio) and Prevnar 13 which contains 13 serotypes (kinds) of streptococcus bacteria. To me, that is 18 pathogens in all instilled directly into the blood stream of my child, bypassing all the natural defense modes. I noticed same day after my son was vaccinated twice, that he was staring in space for few seconds. The second time he stared longer, but came out of it when i got his attention. To me, that reaction is too similar to a petite mal seizure. Now, i am weary to continue the rest of the vaccine seires. Upon recent visit to his PCP, i made mention of my finding, unfortunately, the dr. couldn’t care less. he thinks differently. he believes vaccines can do know harm. Now i am in search of a better pediatrician. The dr didn’t even tell me that pentacel came out on the market just 2010. To me I prefer older brands that has been around for ages. These new “hurry up” vaccines to me have not been tested long enough to be on the market. I now just found out that some vaccines are made with aborted fetus/babies. especially live vaccines like MMR and chicken pox. I want no part of that, as I do not believe in abortion. The pharmaceutical companies wont tell you that. example whenever a vaccine ingredient contains human deploid cell/tissue and/or The WI-38 and MRC-5 cell cultures it has parts of cells from aborted babies. That is wrong! http://www.immunizationinfo.org/issues/vaccine-components/human-fetal-links-some-vaccines.
    Prevnar and Pentacel have caused adverse reactions in several babies. This i know after the fact. But now, I will no longer play Russian roulette with my son’s life. Because at the end of the day it’s 50/50.
    One that does not believe in a “one size fits all medicine.” If I can find such a Doctor. I will get titers done to see my son’s immune status, before I go ahead with the rest of the vaccine.
    Don’t get me wrong, i do believe that some vaccines are befeicial, and some do more harm than good.
    I do not believe in one size fits all medical care. Sometimes common sense is better. We have to learn to think outside of the box.
    Pharmaceutical company are in the money making business so of course they are going to promote their newest invention. Even if they have to make up stories and instill fear.

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