Oct 12 2010

Vaccine Suit to be Heard by Supreme Court

The US Supreme Court is about to hear a case involving an alleged vaccine injury. This one does not involve thimerosal, MMR, or autism – it involves neurological injury allegedly from an older version of the DTP vaccine. However, this case would have implications for the many autism-related claims being made.

The case is not about the facts of the claim – whether or not the DTP actually caused any injury in this case, that of Hannah Bruesewitz, but rather about the vaccine court and the ability of parents to bring suits against vaccine manufacturers.

In 1986 the National Childhood Vaccine Injury Act created a special court, the vaccine court, the purpose of which was to provide an alternate method for determining who deserves compensation for a possible vaccine injury. The vaccine court functioned to protect both citizens and vaccine manufacturers. It provides an expedited route to compensation, with a generously low threshold for evidence. For certain listed injuries, compensation is automatic.

The vaccine court also provides protection for vaccine manufacturers, because it puts barriers in the way for those families who want to bypass the vaccine court and sue companies directly. The concern is that without such protections vaccine manufacturers would not be able to function – it would simply cost them too much money to constantly defend themselves from suits, and they would always be at the mercy of a quirky jury decision.

There is precedence for this. In the 1980s lawsuits began to emerge claiming that silicone breast implants were causing cancer and autoimmune disease. This led to many settlements, some in the millions of dollars, against silicone manufacturers, including  multi-million dollar settlements. The capper was a class action lawsuit that was settled for 3.4 billion dollars.

As a result of these lawsuits Dow Corning filed for bankruptcy, and silicone manufacturers Dow Corning, Bristol-Myers Squibb, and Bioplasty stopped producing silicone for implants by the end of 1992. In essence, the silicone breast implant industry was destroyed by lawsuits.

All of this was happening at a time when the scientific evidence was coming in strongly against any connection between silicone implants and chronic disease, such as autoimmune disease.

Imagine the same scenario playing out in the vaccine manufacturing industry – lawsuits shutting down vaccine companies even as scientific evidence is coming in showing that vaccines do not cause the alleged injuries. This would have unacceptable public health ramifications.

The situation is even worse for vaccines, because there is an organized and highly motivated anti-vaccine movement. They would like nothing better than to shut down the vaccine industry with harassing lawsuits.

This is the issue now at stake in the Supreme Court case – was the National Childhood Vaccine Injury Act intended to prevent lawsuits against vaccine manufacturers? Actually, the suit deals with a specific kind of suit, that dealing with manufacturing defects. It is already clear that the act was meant to prevent or minimize lawsuits dealing with known risks and side effects from vaccines. Essentially, as a society we accept that vaccines are a public good but come with a small risk. So we put a small tax on all vaccines and use that money to compensate those who are unlucky and get a side effect.

But does this mean that vaccine producers are immune to liability no matter what they do? What if they knowingly produce a bad vaccine, or make a mistake in manufacturing? Now we are not talking about an unavoidable rare side effect, but a manufacturing error. This is the precise issue of the Supreme Court case.

The parents bringing the suit allege that the vaccine company, now part of Pfizer, kept producing an older version of  the DTP vaccine even when a newer and safer version was available (this newer version is now in use). This, they argue, makes the company liable for injuries from the older and less safe vaccine.

While the facts of the claim are not at issue, it is instructive to review them. The claim is that the older whole cell pertussis vaccine, part of the diptheria, tetanus, pertussis vaccine (DTwP) has been largely replaced with the DTaP vaccine, which contains an acellular pertussis component. This change was partly due to rare cases of neurological disease (seizures and encephalopathy) following DTwP being given, as in this case.

However, scientific evidence did not support an actual link between DTwP and neurological injury. A 1990 review found:

There clearly is an increased risk of a convulsion after diphtheria-tetanus-pertussis immunization but no evidence that this produces brain injury or is a forerunner of epilepsy. Studies have also not linked immunization with either sudden infant death syndrome or infantile spasms.

In 1993 the Institute of Medicine conducted their own review of the evidence and concluded.

The committee concluded that the evidence is insufficient to indicate either the presence or absence of a causal relationship between DTP vaccine and permanent neurological damage.

But a later (1994) extensive population-based case control study found:

This study did not find any statistically significant increased risk of onset of serious acute neurological illness in the 7 days after DTP vaccine exposure for young children.

As far as I can find, that seems to be the last of the major studies of DTwP and neurological injury.

But, as the silicone implant case demonstrates, having the science on your side is not enough to protect companies from serious financial harm due to law suits, even to the point of destroying an industry.

Conclusion

The results of this case will be very interesting to follow. I don’t know all the details of the case (what the company knew at the time and their decision-making process – details that may become relevant), but my review of the scientific evidence indicates that, once the dust had settled it seems as if there is no causal connection between DTwP and neurological injury.

That question aside, the legal issue is whether or not parents can bypass the vaccine court and sue companies directly for alleged manufacturing defect. This is a tough question, and will likely require a delicate balance of two competing interests. On the one hand, we want companies to be motivated by the threat of suit to adhere to the best manufacturing processes possible and to produce the safest vaccines possible. On the other hand, we don’t want frivolous, misguided, or even malicious suits to threaten a much-needed industry.

The case may hinge on the interpretation of the intent of the Vaccine Injury Act – not what the law should be, but what the law actually states. This, of course, may lead to a legislative battle to pass a new law that will strike the proper balance of accountability and protection that the vaccine industry requires.

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26 responses so far

26 Responses to “Vaccine Suit to be Heard by Supreme Court”

  1. CWon 12 Oct 2010 at 12:33 pm

    After speaking with the director of an anti-vaccine group in Michigan, the scary thing is that even if the vaccine industry was destroyed by lawsuits, vaccine opponents already have a built-in “move the goalpost” strategy in place to explain why there’d be no decrease in neurological diseases like autism: pesticides, fastfood, antibiotics, etc.

  2. SARAon 12 Oct 2010 at 3:07 pm

    This is a tough question, and will likely require a delicate balance of two competing interests. On the one hand, we want companies to be motivated by the threat of suit to adhere to the best manufacturing processes possible and to produce the safest vaccines possible. On the other hand, we don’t want frivolous, misguided, or even malicious suits to threaten a much-needed industry.

    What is amazing is how many questions in life are just this muddy. Too many people want a “right” and a “wrong” answer. Not everything is quite that easy to pin point. So many things aren’t even easy to understand.

    Thank you for once again providing a fair and clear assessment of a complex issue. You are rarely neutral, but I think you try very hard to take into account all evidence and ethical questions. And you do so with respect rather than emotional rhetoric.

  3. ChrisHon 12 Oct 2010 at 8:16 pm

    Here is the decision from the Vaccine Court:
    http://www.uscfc.uscourts.gov/sites/default/files/MILLMAN.Bruesewitz2.pdf

    It has her whole seizure history. It seems she recovered, then had more seizures later… and there is an issue as to whether or not she had a fever.

    There are some familiar names in it: Shoemaker, Kinsbourne, Geier

  4. sonicon 12 Oct 2010 at 9:29 pm

    I could be mistaken, but this study (done in 2003) seems to disagree with your statements about the safety of these vaccines–

    http://www.greatplainslaboratory.com/home/chinese/PhysicianReference6.pdf

    Am I misreading this?

  5. PScotton 12 Oct 2010 at 9:38 pm

    I really enjoy this site, and I’m proof that well-articulated skepticism can go great lengths in educating non-scientists.
    However, I do find myself knitting by brow sometimes at the tone of frustration and anger and often downright rudeness toward people who aren’t as inclined toward acting on logic.

    I just ask, (and I welcome arguments to the contrary here) that everyone keep history in mind. Whether common or not, recent human history is filled with realizations, often hard-earned, that certain chemicals we were working with and surrounding ourselves with and sometimes ingesting–were really bad for us. I can think of several instances when there were scientists and industry spokespersons lining up to assure these substances were safe.

    What I have a hard time balancing then, is, given this pattern, who are people supposed to believe? Do I think vaccines are giving people autism? No. Do I think these people are wonky and dangerous? Hell yes. But to get mad at people for their loss of trust, is a bit like getting mad at an abuse survivor every time he winces from your sudden movements. It’s like calling a kid an idiot who has been smacked around a lot, just because he doesn’t realize he’s in a safe home now and can come out from the closet.

    In the past, bad stuff was done to unsuspecting people, both through negligence and greed. It stands to reason then that somewhere, right now, it’s happening again. So how can you be so cavalier when you expect people to believe you?

    I don’t know what the answer is to any of this, but I don’t think being condescending is the answer. Maybe it just takes time for people to start trusting scientists again. If you scoff at that, by the way, don’t scoff in my direction, scoff in the direction of the scientists and experts employed, say, by big oil, who continually tell us that climate change nee global warming, is a myth.

    I’d love to know what you guys think about my reasoning. I just hope you can give me feedback without being douchey about it.

    Thanks!

  6. ChrisHon 12 Oct 2010 at 10:41 pm

    sonic:

    Am I misreading this?

    Yes. The paper is by the father and son team, the Geiers. I suggest you click on the link I provided on the remarks on the them in their Vaccine Court lawsuit:

    On February 21, 2002, the undersigned issued an order to Show Cause why one of petitioners’ experts, Dr. Mark R. Geier, should not have his testimony stricken as irrelevant.

    Petitioners filed Dr. Mark R. Geier’s first affidavit, dated July 26, 1999. P. Ex. 20. Dr. Geier is an obstetrician-gynecologist. Id. at 7. He is board-certified in genetics and forensic medicine, but not in obstetrics. Id. He is not a pediatrician, neurologist (adult or pediatric), or internist.

    Regarding Dr. Geier, the specialist in genetics and forensic medicine, his affidavits and report are not credible. First, being a board-certified geneticist and forensic medicine specialist does not qualify him to diagnose neurological diseases and offer an opinion as to how doctors who do specialize in neurology define “encephalopathy.”

    In addition there is this 2006 paper:
    Encephalopathy after whole-cell pertussis or measles vaccination: lack of evidence for a causal association in a retrospective case-control study.
    Ray P, Hayward J, Michelson D, Lewis E, Schwalbe J, Black S, Shinefield H, Marcy M, Huff K, Ward J, Mullooly J, Chen R, Davis R; Vaccine Safety Datalink Group.
    Pediatr Infect Dis J. 2006 Sep;25(9):768-73.

    PScott:

    I’d love to know what you guys think about my reasoning. I just hope you can give me feedback without being douchey about it.

    I suggest you read this excellent book: Lies, Damned Lies and Science. It should help you figure out who has an agenda, and who has more to lose. In other words, who the stakeholders are.

    For instance, look at the paper sonic referenced. It was written by a doctor and his son (who has an undergraduate college degree). They have a company called “Med-Con” which is a medical/legal consulting firm. Their exploits have been documented here.

  7. AnneBon 13 Oct 2010 at 12:21 am

    “That question aside, the legal issue is whether or not parents can bypass the vaccine court and sue companies directly for alleged manufacturing defect.”

    The Bruesewitz plaintiffs did file a claim in vaccine court, where they lost. They rejected the judgment and, as the Vaccine Act allows, then filed their suit against Wyeth. The case doesn’t at all deal with the issue of bypassing the vaccine court – it deals with the issue of what claims plaintiffs can assert against vaccine manufacturers after the plaintiffs have satisfied the requirement of going to vaccine court.

    There was a claim of manufacturing defect in the case, which there is no question the plaintiffs were entitled to assert. They lost on that claim because they didn’t prove it. The Supreme Court is not going to decide anything relating to the claim of a manufacturing defect, though.

    The issue before the Supreme Court is how to construe the language in the Vaccine Act that says that vaccine manufacturers are not liable for injuries or deaths that “resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

    You can see the Supreme Court’s statement of the issue here:
    http://www.supremecourt.gov/qp/09-00152qp.pdf

    If the Supreme Court overrules the Third Circuit Court of Appeals in this case, vaccine manufacturers will be faced with having to litigate, on a case by case basis, whether the alleged side effects of a vaccine were avoidable or not.

    I agree that there are competing policies that need to be reconciled, and the Court’s task in this case will be to determine how Congress intended to balance those interests when it used the language that it did.

  8. sonicon 13 Oct 2010 at 1:12 am

    ChrisH-
    Thanks for the info. So I did not misread the article, you just think the authors shouldn’t be trusted. The info you gave did not address the concerns in the paper however. The paper you cite does not cover the concerns either.
    I’ll cite these references (the first is also quoted in the blog post).

    http://www.ncbi.nlm.nih.gov/pubmed/7906066

    “The committee reviewed information from a wide range of both professional and lay sources and found that the evidence is consistent with a possible causal relation between DTP vaccine and acute encephalopathy, although it is insufficient to establish causality.”

    (I believe that it was proved that smoking cigarettes causes lung cancer in 1998.)

    http://archpedi.ama-assn.org/cgi/content/abstract/150/5/457

    “Conclusions

    These results confirm that minor adverse events are less frequent after administration of the acellular pertussis vaccine. In addition, these data suggested that seizures and hospitalizations associated with pertussis vaccination are less frequent after administration of the acellular pertussis vaccine in age groups for which it is now recommended.”

    http://www.health.gov.on.ca/english/public/pub/immun/dtapipvhib.html

    “This newer vaccine (acellular pertussis vaccine-aP) causes even fewer of the minor reactions and chances of brain irritation following this vaccine remain extremely rare. The benefits of this vaccine are much greater than the risks.”

    http://www.cdc.gov/mmwr/PDF/rr/rr4607.PDF

    “Adverse events were reported significantly less commonly among the children who received DTaP.”
    (note this is CDC from 1997…)

    I believe this situation is quite a bit different than the analogy to silicone implants implies.

  9. jaranathon 13 Oct 2010 at 11:49 am

    PScott:

    I get what you’re asking, and I’ll get to that in a minute. But first, I’d like to point out that you have front-loaded your question with a defensiveness that is unwarranted, or at least grossly out of context. People get angry over this issue, yes. But so far, no commenter, and certainly not Steve, has been any sort of a “douche” in this thread. To then demand that we not be douches…well, frankly I think that can be seen as a little douchey in itself. I don’t think you really meant anything by it, but you’re asking us to consider the impacts of our words and the appearances of our actions, so…

    Now, to your main question:  Yes, I think that is a problem for some people. I can’t tell you how much I hate the popular meme that scientists are just making it up as they go along, just guessing randomly until they get one right, and thus they’re always completely changing their minds and we shouldn’t trust them.

    It’s an especially nasty meme because a huge factor in perpetuating it is awful science reporting and science education. We scientists and science-lovers can do some on the education end, but I don’t know what to do on the media end. Especially when much of the poor science reporting is hard to pin on the journalists themselves; there are plenty of pseudoscientists out there yammering about their work to anyone who’ll listen, and genuine scientists (or their employers) pushing misrepresentations of their work to the media for their own selfish purposes (such as the recent “missing link” fiasco).

    But our strong criticism is not, in fact, aimed at the general public, at the average parent who might not know better.  It’s aimed at people who should know better:  Wakefield, Geiers, Dorey, McCarthy, etc, and many of their minions. These people have been told why they’re wrong, have been shown proper evidence, and choose to reject it for poor reasons. Some of them probably even know much or all of what they’re selling is a lie, either thinking the ends justify the means or simply hoping to exploit the situation for prestige and profit. I think the anger they receive is quite justified.  And when it is appropriately applied to specific targets, I think strong criticism and condemnation is a useful, functional part of the broader spectrum of public skeptical action.

  10. PScotton 13 Oct 2010 at 12:12 pm

    Thanks, jaranath, for the clarification on the focus of the frustration.
    My main concern, I suppose, is a concern that I have as a non-scientist, which is the who-to-believe concern. I think that if there’s anything I’ve learned from this blog it’s the value and safety of cold skepticism. But I sometimes feel that the skepticism is a bit convenient in that it sometimes downplays the effect of actual incidences in the past when people have been lied to and harmed.
    Is everything a conspiracy? No. Have their been conspiracies? Yes. I like the suggestion of tracing research to publishing sources and the motivations of the authors themselves. Is there a non-partisan site that keeps up with scientific or academic announcements and gives an impartial analysis of the sources behind the research?
    That would be hot.
    Otherwise, and even still, this unspoken mistrust will always exist between people who know enough about history to know that the little guy has so often gotten the shaft, and the people who are trying to get the public to listen to reason. Again, I draw the abuse analogy: “I know you’ve been punched in the past, and I know it came out of left field, but really, I’m not going to punch you, I swear. I’m only here to help you.” And then you’re thinking, ‘yeah, those were the same words of Henry Kissinger.’
    It’s tough. My apologies, by the way, for the cavalier way in which I used the word ‘douchey.’ Although I still hold that there have been comments of severe douchiness in here, I accept my own douchedom in using douche as a blanket term.
    Thanks to everyone for the postings. This reminds me of the advice I given to always surround yourself with people who are smarter than you.
    P

  11. ChrisHon 13 Oct 2010 at 12:27 pm

    Then you should really read the book I suggested. It is not very long, but it is very clear.

    As far as

    Is there a non-partisan site that keeps up with scientific or academic announcements and gives an impartial analysis of the sources behind the research?

    There are several. I usually get the news through their podcasts, but they do have webpages and actual magazines:

    Nature . com

    Scientific American . com (I read it in the library)

    The New York Times Science Tuesday (which I read in the college library)

    There is also the Science Blog Aggregator:
    http://scienceblogging.org/

  12. jaranathon 13 Oct 2010 at 12:51 pm

    Oh, I totally agree PScott. It is very frustrating to me that to the general public, “scientists” are just this monolithic block, such that they can’t distinguish between the Kissingers and the Novellas. That’s why, although I try VERY hard to avoid genuine hatred as I think it’s a Very Bad Thing, “cigarette science” and the people who knowingly perpetuated it is at the top of my list of Things That Enrage Me. It did horrific damage to public trust in science.

    I would suggest you just keep on doing what you have been; ask questions, read places like this and good science books. And just bone up on your basic critical thinking and your understanding of standards of evidence. Knowing what constitutes good evidence and what doesn’t is 90% of the fight right there. See Steve’s comments earlier on consensus science, for instance, and plenty of science blog articles on statistical significance and why it matters, the value of double-blinding, the role of controls, and other ways we keep from fooling ourselves. If I could get the public to understand ONE basic point about science and critical thought, it’d be the near-uselessness of anecdotal evidence.

    I would bet you know most of that already anyway. I guess my point is to just keep on doing what you are, and to recognize that yeah, sometimes its confusing, and there aren’t always clear answers, and even with the right approach you WILL be wrong sometimes. But despite our cultural distaste for mistakes, it’s okay to be wrong. Part of the scientific method is being open to change when good new evidence arrives.

  13. Dawnon 13 Oct 2010 at 1:57 pm

    @sonic: I would recommend, along with reading the link ChrisH gave, that in the future you not use Great Plains Laboratories as a site to find information. They, along with Doctor’s Data, are well-known to be – well, I’ll be polite – rather lax with how they obtain and interpret laboratory data for certain tests. Try PubMed for peer-reviewed publications; they are much more reliable.

    @PScott: it’s hard to post a question when you are expecting to be jumped on. We understand that. But, if you understand our frustration with answering the same questions multiple times, we will understand your frustration and lack of trust in the “science” monolith. (Your second post was much better than your first.)

    The biggest issue, as I see it, is that if a scientist is caught doing something wrong, it’s all over the media. Good scientists disown the work of the bad and his/her publications are removed/highly scrutinized. The truth wins out. However, if, say, Dr Mercola, is proven wrong about something, there is no noise in the media, his believers attack the messenger, and the truth gets buried in the noise.

    The issue with the abuse analogy is that often, the abused go back to their abuser because they have no trust in anyone else, either. Then, when they get abused again and the abuser doesn’t get punished, their trust disappears even more. However, if their abuser (scientist) got punished, then they should feel more trust in the system that science is self-correcting and WILL admit its errors (unlike the unpunished abuser).

  14. sonicon 13 Oct 2010 at 6:41 pm

    ChrisH- Dawn-
    Thank-you for the input. I was not aware that the people I was referencing were problematic.

    (I don’t think people shouldn’t get immunized and I don’t think any companies should have to pay damages if a good product gets replaced by a better one.)

    I will reference what I hope will be more acceptable sources–

    From the article referenced in the blog post above (Institute of Medicine)–

    http://www.ncbi.nlm.nih.gov/pubmed/7906066
    “The committee reviewed information from a wide range of both professional and lay sources and found that the evidence is consistent with a possible causal relation between DTP vaccine and acute encephalopathy, although it is insufficient to establish causality.”

    http://pediatrics.aappublications.org/cgi/content/full/112/5/e348
    “Using an established active surveillance system in Canada, we have documented a marked decline in hospitalizations for postimmunization febrile seizures and reports of HHEs after the abrupt switchover from one particular whole-cell pertussis-based to another particular acellular pertussis-based vaccine in 1997″

    It seems the situation is far from settled, but I’m guessing that it doesn’t matter too much as a better product now exists. (If I read that there was ‘no significant warming over the last decade’ would I conclude that global warming was hog wash?–no, I would not. Just trying to be consistent in my evaluation of ‘not significant’ results.)

  15. ChrisHon 13 Oct 2010 at 7:30 pm

    You cited:
    Vaccine. 1993 Nov;11(14):1371-9.
    Acute encephalopathy and chronic neurological damage after pertussis vaccine.
    Cowan LD, Griffin MR, Howson CP, Katz M, Johnston RB Jr, Shaywitz BA, Fineberg HV.
    Institute of Medicine, National Academy of Sciences, Washington, DC.

    I cited:
    Pediatr Infect Dis J. 2006 Sep;25(9):768-73.
    Encephalopathy after whole-cell pertussis or measles vaccination: lack of evidence for a causal association in a retrospective case-control study.
    Ray P, Hayward J, Michelson D, Lewis E, Schwalbe J, Black S, Shinefield H, Marcy M, Huff K, Ward J, Mullooly J, Chen R, Davis R; Vaccine Safety Datalink Group.
    Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, USA.

    Would you care to tell me which is most recent?

  16. sonicon 14 Oct 2010 at 12:37 am

    ChrisH-
    The article you cited is more recent than the one I cited.
    The study you cite is a retrospective case-control study. These are not the most powerful studies to draw conclusions from.

    To quote from the one you cited–
    “When encephalopathies of known etiology were excluded, the odds ratio for case children having received DTP within 7 days before onset of disease was 1.22 (95% confidence interval [CI] = 0.45-3.31, P = 0.693) compared with control children.”

    Given the type of study and the results actually tabulated, I would maintain doubt in this case.

  17. ChrisHon 14 Oct 2010 at 1:19 am

    Also, look a little more closely at the abstract of the 1993 study.

    Plus, also read the court decision I posted. Perhaps it takes someone who is more acquainted with seizure disorders (like me, a parent of a child who experienced something similar, only not anytime near a vaccine) to fully appreciate it.

  18. ccbowerson 14 Oct 2010 at 2:44 am

    “Is everything a conspiracy? No. Have their been conspiracies? Yes.”

    This line of thinking can ultimately lead to the wrong conclusions, because it does not convey how extremely rare genuine conspiracies are in relation to proposed conspiracies. In your statements you are acknowledging that one extreme isn’t true, but then leave the whole rest of the spectrum as all possible.

    I would continue with ‘Are most things conspiracies? No. Are there a lot of conspiracies? No. Are genuine conspiracies pretty rare and generally isolated to a small group of people? Yes’

    The conspiracy line of thinking is an overemphasis of distrust, and is a problem because it prevents people from keeping their eyes on the ball. People worry about the wrong things… spend little time concerned about things with the highest risk, and spend too much time worrying about the rare but sensational risks.

  19. Steven Novellaon 14 Oct 2010 at 10:57 am

    From reading the research, including all the article cited (thanks for the references) it seems that it is pretty clear that whole cell pertussis did have a higher complication rate of febrile seizures. However – not of subsequent epilepsy or neurological damage, and that is the relevant question in this case.

    There is always doubt in this kind of research. You cannot prove this kind of negative, you can only make judgments about how far existing evidence goes to minimizing the possible remaining effect size. That is why reviews will almost always make statements that seem ambiguous.

    But the bottom line remains – we cannot conclude from the evidence that there is an increased risk of neurological damage from the DTwP. This is, BTW, the same that can be said for silicone implants and autoimmune disease. The level of confidence is not precisely the same, but the situations are analogous.

  20. Todd W.on 14 Oct 2010 at 3:18 pm

    A question I raised elsewhere, would a win for the family in this case set a precedent for other industries? For example, if a safer car is developed, does that mean that other automakers need to immediately switch their production over to the new type from their competitors?

    Also (and I have not yet had time to look into this), at the time the vaccine was administered to their child, was the DTaP still under patent? If so, then Wyeth would not have been able to provide the safer alternative in any event.

  21. Skeptiverseon 14 Oct 2010 at 5:33 pm

    A bit off topic but interseting non the less.

    The Australian Vacination network (AVN) Australia’s version of AoA has had a very bad couple of months sued for copyright infringement, smacked down by the health care complaints comission for publishing false and misleading information and has culminated in the loss of their charitable organisation status only yesterday.

    A win that many australian Skeptics and others parties have been waiting for.

  22. marc82281on 14 Oct 2010 at 11:20 pm

    If the legal question before the court is “whether or not parents can bypass the vaccine court and sue companies directly for alleged manufacturing defect.” then the science behind the facts will not matter at all.

    The case WILL hinge on the courts interpretation of the Vaccine Injury Act, and a part of the analysis they use to come to that interpretation will be congressional intent for some justices. Others (i.e. the “conservatives”) will focus mostly on their interpretation of what the statutory language means and, I would argue, only appeal to legislative intent when it suits their interpretation of the language.

    I’d be surprised if the majority gives much consideration to the policy implications on a question like this unless it’s just to illustrate congressional intent. Like you said Steve, the issue isn’t what the law should be, but what the law “is”, and the court seems to enjoy reminding congress that it’s congress’ job to write good policy, not the courts

  23. ChrisHon 15 Oct 2010 at 11:05 am

    The Washington Post has an editorial on it today (free registration required to read): Family’s vaccine claim is not sustainable

  24. Todd W.on 15 Oct 2010 at 12:29 pm

    @ChrisH

    Thanks for the link. Particularly of importance, I think, was this line:

    The harm, moreover, may not have been unavoidable, as the parents believe, because the alternative vaccine was not approved by the Food and Drug Administration for use on children as young as 6 months until years later.

  25. daedalus2uon 15 Oct 2010 at 10:03 pm

    The legal theory under which they are bringing this is really bad (in my non-legal opinion).

    The wording “that were unavoidable” shouldn’t be there because it makes the law ambiguous. If the vaccine was properly prepared, how can any side effects it causes be avoidable? Was the approval process so flawed that it let a vaccine that had avoidable side effects be approved?

    If so, isn’t that a flaw of the approval process? If it is a flaw in the approval process, shouldn’t the government that operates the approval process be liable?

    If they win this case, all it does is give them the right to sue and try and prove there was a defect, the defect was avoidable, and the avoidable defect is what caused the child’s seizure disorder.

    They have to prove all of those things to a “preponderance of the evidence”, not to the laxer standard of “more likely than not” that was applicable in vaccine court.

  26. Todd W.on 18 Oct 2010 at 11:44 am

    @daedalus2u

    They have to prove all of those things to a “preponderance of the evidence”, not to the laxer standard of “more likely than not” that was applicable in vaccine court.

    More importantly, the Daubert standard would apply, unlike in the Vaccine Court.

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