Taking a vaccine injury case to the Supreme Court

I haven't written much about this before, at least not in this context, but vaccine scares are nothing new, nor is execrably fear mongering journalism about vaccines. Those of you who read Paul Offit's Autism's False Prophets or Arthur Allen's Vaccine probably know about a particularly egregious example of both that occurred in the early 1980s and concerned the DTP (diptheria-pertussis-tetanus) vaccine. In 1982, the local NBC affiliate in Washington, DC aired a special report entitled DPT: Vaccine Roulette. Indeed, Vaccine Roulette was the prototype of the muck-raking, sensationalistic sort of documentary that we've come to know and hate, showing children who were thought to have suffered brain damage due to the DPT vaccine and making it sound as though this was a common event, when later investigations demonstrated that it was not. Still, the DPT vaccine did produce severe neurological reactions, and the scare over it sparked by DPT: Vaccine Roulette resulted in a rash of lawsuits that endangered the vaccine supply.

As a result, lawsuits proliferated, and there were several large jury awards. Due to the fear that litigation would drive vaccine manufacturers either out of business or into giving up manufacturing vaccines due to liability concerns, Congress was driven to "do something." These fears were not unfounded. All but one DPT manufacturer stopped making it, and the last one threatened to do so. In order to safeguard the vaccine supply in 1986 Congress passed the National Childhood Vaccine Injury Act (NCVIA). This law established a no fault compensation system for children injured by vaccines. To administer the compensation, the NCVIA established a Vaccine Court, administered by the Office of Special Masters in the U.S. Court of Federal Claims. Claims against vaccine manufacturers can't be initially filed in state or federal court; they have to go through the Office of Special Masters, where special judges known as Special Masters adjudicate the claims. It is just this court that I blogged so copiously about in 2008 and early 2009 as a result of the Autism Omnibus action, in which the Special Masters of the Vaccine Court instructed representatives for the 5,000 or so children in the action to choose their best cases as "test cases" for the claim that vaccines caused autism. All three test cases lost.

It shouldn't be thought that the Vaccine Court didn't compensate children with legitimate cases of injury due to vaccination. It did compensate many children over the last 22 years. It does so by, as I have pointed out before, using looser rules of evidence and not requiring the Daubert standard for scientific testimony and evidence. There is also a list of "table injuries" that are assumed automatically to be due to vaccine injuries. Compensation covers medical expenses, legal expenses loss of future earning capacity, and others. Even for unsuccessful claims, legal expenses are often covered. Unsuccessful claimants can sue in federal court after losing in Vaccine Court, but this is generally rare.

Several plaintiffs have tried over the years to bypass the Vaccine Court for what I consider to be obvious reasons: More money. Although vaccine court is relatively fast and fair, it caps pain and suffering damages at $250,000, which, as you can imagine, most lawyers don't find too appealing, even though certain lawyers like Clifford Shoemaker have made quite the living off of bringing actions in vaccine court. It looks, however, as though we will soon know whether the Vaccine Court is Constitutional and whether parents can bypass it, as next year the Supreme Court will be hearing a case asking just that:

The justices Monday agreed to decide whether drug makers can be sued outside a special judicial forum set up by Congress in 1986 to address specific claims about safety. The so-called vaccine court has handled such disputes and was designed to ensure a reliable, steady supply of the drugs by reducing the threat of lawsuits against pharmaceutical firms.

The questions in the latest case are whether such liability claims can proceed, if the vaccine-related injuries could have been avoided by better product design, and if federal officials had approved another, allegedly safer drug. Oral arguments in the dispute will be held in the fall.

Interestingly, even though the Third Circuit Court of Appeals ruled for the vaccine manufacturer, concluding that the legislative history of the NCVIA indicated a clear intent by Congress to preclude suing for claims of preventable injuries due to poor design, the case appears to be going to the Supreme Court because vaccine manufacturers and the Obama Administration requested it:

A federal appeals court eventually ruled for Wyeth, now owned by Pfizer Inc., concluding that all design-defect claims were barred under statute. Despite that victory, the company urged the high court to hear the case, saying it seeks final resolution on broader legal questions. The Obama administration also urged review and is supporting the company and the federal law in question.

The case boils down to three questions:

  1. whether the Act preempts all design defect claims against the manufacturer of a vaccine
  2. whether the plaintiffs demonstrated that the manufacturer failed to adequately warn the plaintiffs of the risks associated with the vaccine
  3. whether the plaintiffs provided sufficient evidence of a manufacturing defect to survive the defendant's motion for summary judgment.

I can understand why Wyeth Laboratories might ask for a clarification from the Supreme Court, but it's a risky move. The court had already ruled in its favor resoundingly, writing:

"If we interpret the Vaccine Act to allow case-by-case analysis of whether particular vaccine side effects are avoidable, every design defect claim is subject to evaluation by a court," Smith wrote in an opinion joined by Judges Theodore A. McKee and Joseph F. Weis.

Which is, of course, true.

The question all appears to boil down to what is known as the "preemption clause" of the NCVIA. Under that clause, vaccine manufacturers cannot be held responsible for injuries, deaths, or side effects that "were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings." The question remains what the word "unavoidable" means, with the plaintiffs arguing that an injury due to a design or manufacturing defect of a vaccine is avoidable. The court concluded that Congress had intended to preempt all suits against vaccine manufacturers based on on design defect claims.

Given conflicting rulings and the specter of other cases, apparently Wyeth wanted clarity. The question is: What kind of clarity will it get? If the Supreme Court upholds the Third Circuit Court's ruling, then the Vaccine Court will continue to function as before, which it has done well for 24 years. If, however, the Supreme Court rules that product defect cases can bypass the Vaccine Court, look for the floodgates to open to a slew of lawsuits claiming that some aspect of vaccine design was defective, leading to their causing autism, neurological injury, autoimmune diseases and a variety of other claims of "vaccine injury. The situation has the potential to degenerating into 1985 all over again.

In the meantime, I dread what the anti-vaccine propaganda machine is likely to do with the Supreme Court's decision to take the case. No doubt it will ramp up a propaganda campaign and file a bunch of amicus briefs to the court. If there's one thing the anti-vaccine movement has wanted to do over the last 10 years, it's to destroy the Vaccine Court and allow open season on vaccine manufacturers. This is particularly ironic, given that the grande dame of the anti-vaccine movement, Barbara Loe Fisher, was involved in the passing of the original. However, because the Vaccine Court doesn't compensate everyone and, as the results of the Autism Omnibus test cases demonstrate, is fairly good about not compensating truly frivolous claims, lately Fisher has become hostile to the NCVIA that she helped to pass, while the rest of the anti-vaccine movement has never liked it.

My prediction is that this will be the next Autism Omnibus case for the anti-vaccine movement. they will, more than anything else, want Bruesewitz to win, because that will open the floodgates. Trial lawyers also want Bruesewitz to win, as well. It's a high stakes gamble for both sides. If Bruesewitz loses, the NCVIA is safe for the foreseeable future, and the anti-vaccine movement won't be able to do a thing about it. If Bruesewitz wins, the anti-vaccine movement will be able to orchestrate a flood of lawsuits, and the vaccine supply, already tenuous enough as it is, will be in as much danger as it was 25 years ago.

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My guess is that although the penalty for losing is great for Pfizer (Wyeth), they must consider the risk of losing to be very low indeed. I doubt that the supreme court would overturn the current decision without a pretty strong argument, one which the anti-vaxx crowd really don't have.

The whooping cough vaccine 'controversy' rears up every few years here, with enough doubt sown to make vaccination levels drop off. Last year it got so bad that the immunisation rate was low enough to allow a minor epidemic of whooping cough. The government responded on this occasion by offering free DPT boosters to the immediate famliy and some extended family members of newborns.
About 10 years ago the government responded more bluntly to the anti-vaccine movement by making a tv commercial showing a baby being held up and having a whooping cough fit. It is extremely disturbing and difficult to watch a baby, barely able to hold its head up, cough like that for 5 seconds let alone 30 and the anti-vaxers went unusually quiet for a while thereafter.

Okay...so the goal of antivaxers is to raise the bar of evidence higher than what the vaccine court requires? Meaning it will be more difficult for them to win and receive damages.

On the other hand, their goal may simply be to swamp vaccine manufacturers in law suits so they'll all just simply stop. That way, they achieve their goal of ridding the world of "evil" vaccines. Everyone, start buying stock in the companies that make the treatments for the diseases that will come raging back.

It's all about the money with them.

Perhaps an amicus brief is in order, ala the Nobel Laureates' brief for the evolution case.

Such decisions should not be made by the court in a vacuum of scientific information.

By Leslie Haber (not verified) on 09 Mar 2010 #permalink

I understand Wyeth's position. They really are in a no-lose situation. If they do âloseâ, it does open the floodgates for lawsuits that were so crappy that they failed in vaccine court. Wyeth will then be able to throw up their hands and say woe is us, we need better legislative protection or we will stop making vaccines. With the two options being satisfying the vaccine industry or return of childhood vaccine preventable diseases, Congress really has no choice but to cave and meet the vaccine industry demands.

A change to the vaccine court that might help would be to require that legal fees of the plaintiff paid by the vaccine court be reimbursed if the plaintiff does not accept the ruling of the vaccine court and sues in regular court. Those fees would be recoverable if the plaintiff prevailed in regular court, but not if the plaintiff did not prevail.

I have just as strong evidence that Jenny McCarthy's Wii videogame gave me seizures as they do that vaccines cause autism... When will I have my day in court?

And what about that one guy who got athlete's foot soon after getting his flu vaccine? Does he have a claim?

That whole 'day in court' thing wasn't meant literally, I hope, by the Framers. I think they meant that, if you got arrested by the government, you'd be able to defend yourself, not run the whole thing into the ground because someone hurt your feelings!!!

This is an informative post. This kind of tone is more suitable to people that are simply trying to stay aware of all sides of this controversy (manufactured in your opinion, or otherwise). But when you said:

Although vaccine court is relatively fast and fair

I nearly choked. People have waited for years to have their cases heard before the special masters. Why pretend it's quick and just, when it definitely is anything but?

Vaccine Court??? I understand the premise, but what next...anti-depressant court? Anti-inflammatory court? To a parent who just discovered the existence of such a court, it does sound a bit "big-brother." Who are these "Masters" who sit on the court? This will be a very interesting case indeed.

Anon @ 8: Legal actions of this gravity take time. Look at the length of time it takes an appeal of a rejected disability claim to work its way through the Social Security adjudication system. It's not like small-claims court.

@T. Kord and anon

From a consumer perspective, the vaccine court is much better than taking your case to regular court. The bar for evidence is "more likely than not" which amounts to your needing to show a likelihood of at least 50% plus a little. The case also would not need to compete for time with all of the other civil and/or criminal cases in addition to all of the other vaccine cases, meaning it would be heard far earlier. In a regular case, plaintiff's legal fees are not guaranteed to be recovered, meaning a wealthy company could just drown the plaintiff in costs until they drop the suit. Vaccine court allows for recovery of legal fees.

In all, a suit is easier to file and win in the vaccine court than it would be in regular court.

Who are these "Masters" who sit on the court?

The special masters in the vaccine court are regular federal judges, but since they don't preside over jury trails but a hearing, they're not called that.

In other circumstances a special master is a lawyer appointed for the task.

About 10 years ago the government responded more bluntly to the anti-vaccine movement by making a tv commercial showing a baby being held up and having a whooping cough fit. It is extremely disturbing and difficult to watch a baby, barely able to hold its head up, cough like that for 5 seconds let alone 30 and the anti-vaxers went unusually quiet for a while thereafter.

We need this PSA to come back. I know far too many people who consider whooping cough to be "no big deal". :/

@James Sweet

Sanofi's got a nice ad out featuring J-Lo (aka Jenny from the block) and a whooping baby. Maybe that will help scare people.

By Sid Offit (not verified) on 09 Mar 2010 #permalink

Jenny McCarthy has a new article at HuffPo and boy does she lay it on thick.

For even more amusement, Jesse Ventura also as a 9-11 Truther article up.

By the bug guy (not verified) on 09 Mar 2010 #permalink

A claim in vaccine court differs from a standard lawsuit/claim against a manufacturer in one very important respect: it's "no fault." That means that the claimant does not have to prove that anybody breached any duty of care. All that has to be proved is that the child was injured as a result of the vaccine. It's a lot like workers' compensation systems, where the worker can recover for any injury suffered on the job, regardless of whether anybody was at fault.

If that system goes away, plaintiffs will have to prove that the vaccine manufacturers were negligent, or that their products are so dangerous that they ought to be held liable for any injuries regardless of whether they took all precautions to prevent injuries--a standard usually reserved for activities like purposely causing explosions or keeping lions in your backyard.

It will be interesting to see what position the anti-vaccine crowd argues this. On the one hand, they may want the Supreme Court to declare the vaccine court exclusivity unconstitutional, guessing that they will be able to recover more, or more often, in a "regular" court; or maybe they figure that they can uncover the smoking gun against vaccine manufacturers in discovery. On the other hand, at least some of them may want to allow the vaccine court to continue, because the claims are easier to prove in vaccine court.

I also wonder whether any new legislation is being proposed, and where the Supreme Court's decision might lead. If the vaccine court is found unconstitutional, it's possible that Congress, or the states, would decide that vaccination is so important, and that the manufacturers are at such risk, that it denies any recovery--from any source--to any person injured by a vaccine.

Okay...so the goal of antivaxers is to raise the bar of evidence higher than what the vaccine court requires? Meaning it will be more difficult for them to win and receive damages.

They probably want to go through discovery. Remember, they think that Big Pharma KNOWS that vaccines are dangerous and ineffective, and have some secret document somewhere that proves it.

The rest of us know this is nonsense.

Drug companies would never hide data.

By Sid Offit (not verified) on 09 Mar 2010 #permalink

@20, Sid Offit

Ok, I'll bite. Just like antivaxxers have never falsified or hid data, right? But that's ok, they're the little guys fighting the Big Bad Pharma.

(Wakefield, et all, would disagree)

By Chance Gearhea… (not verified) on 09 Mar 2010 #permalink

Sid Offit said, in regards to a pro-pertussis vaccination PSA:

Maybe that will help scare people.

Really, does someone affiliated with the anti-vax movement really want to play the "you're just a bunch of fearmongers!" card? Seriously??? That is your entire raison d'etre, is fearmongering.

And doing it to some of the most vulnerable people to fearmongering, at that... New parents, I mean, who just want the best for their children. Despite being thoroughly convinced that the anti-vax movement is a bunch of lunatics and that there is no autism link to vaccines whatsoever, my wife still deals with a lot of worry every time our son gets a shot, because she cares so much about him that it's nigh impossible to ignore the seeds of doubt planted by you fuckers.

So please. Don't accuse our side of fearmongering, because that is exactly what you guys do. All the time. Without exception or remorse. Asshole...

I don't understand that "hiding the data" or "conflict of interest" argument. It is a documented and well-known fact that pharma companies have hidden data or tried to spin facts or even fabricate results. Nobody is disputing this. Point made.

However, so what? The argument WISHES it meant that because Pharma companies have hidden data before, it is reasonable to assume that they are hiding data now. This would indeed be a nail in the coffin of the argument except that NOBODY IS BLINDLY FOLLOWING PHARMA COMPANY RESULTS. The system is already set up to treat all findings skeptically and while it is not always perfect, it is certainly a more reasonable, systematic and accurate method than simply screaming "conspiracy" every time the results don't agree with your hypothesis.

Calling for increased scrutiny and research is certainly an option, except that that's what the "mainstream" scientists are calling for too. Not everyone buys the "autism is caused entirely by genes" argument, and I think you'd be hard-pressed to find anyone who believes that it's entirely genetic. There are so few disorders in the world that are entirely genetic that it would take some pretty wild sophistry to explain autism in that way. However, there was evidence that led some researchers down that path, and when they looked further they found MORE evidence. When the vaccine pathway was investigated, no strong evidence was found.

I guess I just don't understand why saying "Pharma companies have hidden results" or "soandso has ties to a Pharma company" is an argument for or against anything. It seems like it's simply a smokescreen that separates science and skepticism from assessing the sanity of the situation (GOD I love alliteration).

Guys, can you help me with this Bill Gates quote?:

"The world today has 6.8 billion people. That's heading up to about nine billion. Now if we do a really great job on new vaccines, health care, reproductive health services, we could lower that by perhaps 10 or 15 percent."


He is providing abortion on demand?

Lowering infant/child mortality decreases the need for large litters. Proper reproductive health information (contraception, sex ed) lowers unwanted pregnancies. I think it's gonna take economic stability on top of that (and governments that don't murder large numbers of their own people) for most third world populations to stabilize, but he's not entirely off base.

By mikerattlesnake (not verified) on 09 Mar 2010 #permalink

He didn't mention child mortality.

I'm specifically asking about this part of his quotation:

" The world today has 6.8 billion people. That's heading up to about nine billion.
Now if we do a really great job on new vaccines... we could lower that by perhaps 10 or 15 percent."

How does doing a "great job on vaccines" result in world population being lowered by "10 or 15 per cent"?

Okay, but when you put in that '...' you take out a pretty significant part of the quotation. I doubt he's suggesting that vaccines will be responsible for killing 10-15% of the world's population, since that would run counter to everything he's worked for in his foundation.

The truth is probably close to what mikerattlesnake said - fewer unwanted pregnancies, advanced health infrastructure and lower infant/child mortality (due to better vaccines) will result in more economically stable countries which will lower the need for large numbers of children, resulting in political stabilization and reduction of world population. The most stable countries in the world have lower crude birth rates, but higher LIVE birth rates.

@Dale, the quote really needs full context to make sense. Gates starts out by talking about how shocked they were to discover that lowering the death rate reduces population growth. It's because when people are mostly sure their kids will reach adulthood, because there's less risk of diease, they're more likely to only have two or three, rather than having as many as they can, because they don't know how many, if any, will live.

Although vaccine court is relatively fast and fair, it caps pain and suffering damages at $250,000, which, as you can imagine, most lawyers don't find too appealing, even though certain lawyers like Clifford Shoemaker have made quite the living off of bringing actions in vaccine court.

I don't know if this is a major concern for the lawyers. The lawyers are paid based on the amount of work billed, not on the award.

Lawyers are paid regardless of whether the client wins.

So Dale, where did you find that quote? It's very clear from the context, that someone is using it deceptively.

Dale asks:

"Guys, can you help me with this Bill Gates quote?:..."

Easy. Bill Gates is a computer guy - he doesn't "get it" that reducing infant and child mortality will not decrease population growth.

In reality, the decrease in family size doesn't come until people see that they don't need to have lots of children to have support in their old age. That - historically - has taken a couple of generations.

In reality, decreasing infant and child mortality through vaccination will increase the rate of population growth.

I'm willing to forgive Bill Gates that bit of ignorance of human population ecology, given that I still can't fathom Windows 7.


Bill Gates also said, "By significantly scaling up the delivery of life-saving vaccines in developing countries to 90 percent coverage -- including new vaccines to prevent severe diarrhea and pneumonia -- the model suggests that we could prevent the deaths of some 7.6 million children under 5 from 2010-2019." Yeah, that's population control right there, saving 7.6 million children.

Admit it, Dale, you don't want vaccines to work. You wish with all your heart that those children die of vaccine-preventable diseases because, if they don't, you'd be proven wrong. And, well, we can't have that, can we?

I mean, if we're going to just randomly dissect everything a public personality says about vaccines and all...

God, I hope "W" didn't say anything about vaccines.

Kudos to Jennifer Lopez on her whooping cough public service announcement; we've run it here at our local HD and it's a very moving clip.

Hasn't this been the pattern of the antivaxers from the beginning? They scream and holler and stamp their feet, then the rules get bent (if not broken) for them in a way they aren't for anyone else, but that's still not enough to let them win, much less win all the time in a guaranteed (and in this case taxpayer-funded) gravy train, so they stamp their feet some more.

Can a perspex box with twinkly lights file an Amicus Brief with the SCOTUS?

The Bruesewitz case doesn't appear to be an attack on, or an attempt to bypass, Vaccine Court. The Bruesewitzes did go to Vaccine Court, where they lost. Under the NCVIA, they were then permitted to file a tort case, which they did.

The issue in that later case was the scope of their tort claim, since the NCVIA provides that vaccine manufacturers are not liable "if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings." 42 U.S.C. section 300aa-22(b)(1)."

I think the US Supreme Court took this case because there have been conflicting interpretations of this language, so its legal effect varies from one jurisdiction to another. This federal law should be applied uniformly, and guidance from the Supreme Court is necessary unless Congress decides to amend the Act to make its intent clearer.

I don't think that the Bruesewitz case threatens the operation of the Vaccine Court, since it raises the issue of what happens after a Vaccine Court case is concluded. Of course, it does affect the potential liability of vaccine manufacturers for design defects in a tort action that is permitted by the Act.

For those interested, there's a copy of the Petition for Certiorari here.

"I can understand why Wyeth Laboratories might ask for a clarification from the Supreme Court, but it's a risky move."

Not nearly as risky as leaving things the way they are.

Why would a pharma company want the US Supreme Court to hear a U.S. Court of Appeals decision that affirms that the Vaccine Court provides the exclusive remedy? First, there are 11 U.S. Courts of Appeal, so a win in one does not set binding precedent in any of the others. To establish binding precedent at the federal level would require defending a suit filed in the U.S. District Court of each of the other 10 federal appellate courts and taking that to those appellate courts, and getting each of the appellate courts to publish the decision (as generally, decisions that are not published in the official reporter for the court are not binding precedent, even in the region covered by the appellate court. Further, in the U.S. 9th Circuit, the decision of one panel, even if published, is not binding on another panel -- which is one reason so many grants of cert. come from the 9th Circuit). A U.S. Supreme Court decision is binding on all federal courts.

Further, a tort suit can be filed in state court. Absent a holding by the U.S. Supreme Court that the Vaccine Court is the exclusive forum for suits alleging that a vaccine caused injury, the pharma companies are also subject to suit in any of the state or city courts in the 50 states, plus the D.C. municipal court, and the courts of Puerto Rico and the Virgin Islands. Sooner or later judges in one or more of these courts will hold that the Vaccine Court is not the exclusive forum, and a full trial, including pre-trial discovery, experts (and, note that not all state courts follow Daubert, and some that do mainly only pay lip service to the idea that the judge is supposed to screen out junk science), and possible adverse judgment, will be required.

Typically, state courts require completion of discovery before they will accept a motion for summary judgment, so defendants run up a lot of defense costs, especially in expert intensive litigation (and vaccine caused injuries are expert intensive -- just recall how long the trial of the Omnibus Hearings took). Also, certain state courts are well-known as plaintiff-friendly fora for class-action suits. For instance, thereâs a county in rural Mississippi where the main industry is class action litigation. There are others. And, there are differing standards for proving injury across the states. The saying in West Virginia is "No proof? No problem."

Further, the class action plaintiffsâ attorneys can do right well in settlements of class action suits. A recent example is reviewed in the article âWho's the Real Winner Here?â (Mar. 5, 2010), The California Civil Justice Blog, http://www.cjac.org/blog/2010/03/whos-the-real-winner-here/ The article reviews the terms of the Dannon Yogurt class action settlement (as described in an ad in Newsweek). As part of the $35 Million settlement (largest of its kind in history), Dannon, without admitting guilt, has agreed to slightly change its ads. It will, for instance, replace the words "clinically proven" or "scientifically proven" with "clinical studies show," and, similar phrases. (Hope that clears that up!) Dannon will also list the genus, species, and strain designation for the bacterium it has trademarked as âBifidus Regularisâ (which happens to be âBifidobacterium lactis DN 073-010â if youâre a real botany guru and care about such things. The rest of us canât even say it). Additionally, every American who has seen one of the commercials (hint: Jamie Lee Curtis appeared in them, in case you need to convince someone you saw one â just say how well sheâs aged since âTrading Placesâ, where as Eddie Murphy didnât look all that good in âDream Girlsâ) is entitled to $15 cash money in genuine US federal Greenbacks, with no questions asked -- provided that you fill out a form, conveniently included in the ad (which was published in Newsweek). If you are willing to sign on the dotted line that you really (as in âScoutâs Honor reallyâ and not ââIâm really not married,â reallyâ) did eat that a lot of the yogurt (and not some other brand), you can get up to $30. But, if you were a hard-core Dannon eater, you can get up to $100. However, for anything over $30 you had to have kept your grocery receipts (so, if you see someone combing through your trash, donât assume that they are in the identity theft business, they may just be looking for grocery receipts for Dannon Yogurt purchases). Youâll also have to sign a statement that you're submitting the claim under penalty of perjury (so, this is a âBill Clinton reallyâ).

And, the lawyers? Glad you asked. Coughlin Stoia Rudman & Robbins, of San Diego, CA, which brought the suit, will get up to $10 Million in fees, plus expenses. It's a lot of work protecting us against BIG YOGURT.

Makes you feel all warm and fuzzy about class actions, donât it. And, it's a pretty fair illustration of one reason why a vaccine manufacturer would risk a good judgment from a federal appellate court in a hearing before the U.S. Supreme Court.

This still didn't make sense to me, so I looked at the U.S. Supreme Court's docket entries and Wyeth's filing with the Court.

Wyeth didn't file the petition for U.S. Supreme Court review; the plaintiffs did. But Wyeth agreed that the Court should hear the case. Its reason was that the Georgia Supreme Court has ruled that its state courts can hear vaccine injury cases. Wyeth asked the Supreme Court to review that decision, and the Supreme Court should decide soon whether to take it (and it could be considered along with the Third Circuit case that it just took).

Wyeth agreed with the plaintiffs petition for certiorari (review) because of the conflicting court opinions in the Third Circuit and Georgia.

No matter what the parties' motives, this will be a fascinating case to follow.

I just finished reading the Pennsylvania Court of Appeals (federal case) and the case from the Supreme Court of Georgia (state case). wfjag's comments are well taken. Adding to them is the idea that the Georgia case really, really is rotten to take up to SCOTUS, while the federal case is very well written and argued and is IDEAL to take up to SCOTUS. Since SCOTUS can exercise jurisdiction in situations where there is diversity among the various courts of appeal. However, that is NOT the case here, since Georgia is a state case. Wyeth is very wise taking this up, and, it is highly unlikely that SCOTUS would render a decision that would leave such a fundamental area of society in disaray. I believe that this will result in a big win for vaccines. Note that Chief Justice Roberts will not participate.

Autism has little to do with vaccines, but has everything to do with parent heath and lifestyle choices that affect methylation pool, liver health and antioxidant status during the period in which epigenetic reprogramming of reproductive cells takes place, in response to environmental cueing that includes diet, sleep, drug exposure, and chronic stress load.

Parent age, lifestyle habits - especially during teen years - but also later, and maternal health status during pregnancy are part of the key to understanding epigenetic diseases that affect many pathways and therefore, many organs and systems - including the immune system. Parents, first and foremost, are the source of problem. Child environment and exposure routes is second. Vaccines are far down the list of additive causes.

Downtown LA is an excellent example of geographical concentration of autism cases, documented in recent studies that show concentration foci of reported cases, statewide.

Twenty bonus points on today's pop quiz, if you can tell me why.

Susceptible infants are already 'hardwired' for autism before they are exposed to the lengthy shot series of vaccine shots given over the first two years of life.

The small portion of cumulative cause that may be attributed to vaccines lies not in the stabilizers used, but rather in the vaccine immune response and additional ROS load induced. Autistic-spectrum infants have very crappy free-radical mop up, right from the get-go.

The post-natal brain is undergoing a tremendous burst of growth that will culminate in 85% mass growth by age 5 or 6 and therefore, experiences an exceptional cellular energetic load and byproduct production rate in the first years of life.

It is also a time when many children are also exposed to modern, exceptional levels of myriad sources of environmental pollutants capable of consuming much of the available pool of free radical scavengers.

If you think this is a problem of urban centers, no. For a well documented example, please find and read about the BRAVO air quality study, Big Bend National Park and the local and long-distance sources of aerosol pollutant haze.

Be prepared to be shocked. The US is NUMBER 2 polluter nation. 1 + 1 = 2


Downtown LA is an excellent example of geographical concentration of autism cases, documented in recent studies that show concentration foci of reported cases, statewide.

Only in the areas where the parents have enough wealth to get the diagnoses. The concentrations of autism are centered around treatment centers where middle-class educated parents are more likely to bring their children for treatment.

If you look at the demographics you will find that autism is caused by being white. Don't believe me? Then read this (be sure to watch the little video clip):

"Autism caused by whiteness and affluence." When this headline popped up on my Twitter page, I had to roll my eyes. The subject of the tweet was a recent study from the Mind Institute which found 10 clusters of autism throughout California. Each of these clusters were in an area that had a large concentration of white, highly educated parents.

So, Philip, how safe is pertussis, tetanus, diphtheria, measles, mumps, Hib... and the rest compared to the vaccines?

Are we to trust that the actual diseases are safe?

As to your first point let's consider Hepatitis B, a blood borne or sexually transmitted disease. We inoculate for this sexually transmitted disease at birth, so I would say in that instance the risk of vaccination outweighs that of the disease. In other instances, such as influenza, the vaccine often contains a preservative that has been banned in much of the world over toxicity concerns, has no good US toxicology data and is 49% by weight ethyl mercury. In the case of gardasil there have been a tremendous number of serious adverse events while one must suppose, without data that immunity would last decades to be efficacious, certainly a rarity in any previous vaccine. So I would think clearly a more rigorous look at the risk/benefit ratio is in order in many instances. However, more to the point if a hospital accidentally infects you with Hep B they are held responsible and liable. If a vaccine manufacturer harms you with a vaccine (unless you wish to argue they are 100% safe) they are "immune" from liability. This is a stupid and unwise idea.

As to to your second point, don't be a smart alec.


One fatal error in your comment: Hepatitis B is not just sexually transmitted. It is one of the most common infections on the planet, and is deadly to children.

If a child has it and bleeds on another child, the other child will get it. Hepatitis B tends to give those who get it very young a deadly liver cancer.

Why should I believe you and your blog if it contains that very simple, and deadly error? Even the influenza vaccine is available without thimerosal (and you are doing pure scaremongering if you claim it causes harm.... common table salt contains at least all of its weight of deadly elements! Sodium will burn right through you, and chlorine gas is pure death!).

You claim there have been serious effects from the HPV vaccine, but you fail to document them. Why?

What you need to do is tell us, with actual scientific evidence, what the relative risks are from the vaccine versus the diseases. Provide real data, not your blatant assertions. This blog post was specifically about a pertussis, diphtheria and tetanus vaccines. Detail to us exactly what the risks are from the DTaP vaccine and those diseases. Show us how much "safer" an infant is without the DTaP, especially in light to how deadly pertussis is to children under six months old. And by evidence, not to a blog... but too actual scientific research like the following:

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.

Economic Evaluation of the 7-Vaccine Routine Childhood Immunization Schedule in the United States, 2001
Zhou F, Santoli J, Messonnier ML, Yusuf HR, Shefer A, Chu SY, Rodewald L, Harpaz R.
Arch Pediatr Adolesc Med. 2005;159:1136-1144.

Autism and Thimerosal-Containing Vaccines. Lack of Consistent Evidence for an Association
Stehr-Green P, Tull P, Stellfeld M, Mortenson PB, Simpson D
American Journal of Preventive Medicine, August 2003, Vol. 25(2):101-6

Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years
Thompson WW, Price C, Goodson B, et al; Vaccine Safety Datalink Team
N Engl J Med, Sep 27, 2007; 357(13):1281-1292

Impact of the Thimerosal Controversy on Hepatitis B Vaccine Coverage of Infants Born to Women of Unknown Hepatitis B Surface Antigen Status in Michigan
Biroscak BJ, Fiore AE, Fasano N, Fineis P, Collins MP, Stoltman G
Pediatrics, June 2003, Vol. 111(6):e645-9

How on earth is HepB even relevant to autism? Autism rates are just as high in countries without HepB on the routine schedule as in the US, which seems to make it highly unlikely it contributes to the development of autism. In fact, since autism is a worldwide issue, it seems to me that if the cause is vaccines, it can only be caused by vaccines that are given worldwide. Of course, that might lead to evidence that vaccines do not cause autism, so it is easier for American antivaxers to just ignore the rest of the world.

Wren, it's not. However, to the ignorant Hep B appears to be unnecessary to give to infants, so it is an easy tool with which to demonize vaccines in general. I'm sure there's a name for the logical fallacy, but anti-vaxxers who bitch about Hep B are basically attempting to apply arguments against an individual to the entire group.

@45 ... Sex and IV drug use are the ways ADULTS get HepB. Children have their own infection routes.

In one study of non-sex, non-blood spread of HepB, the behaviours most strongly associated with prevalence of HBV were sharing of bath towels (OR = 3.1, 95% CI 2.10-4.5), sharing of chewing gum of partially eaten candies (OR = 3.4, 95% CI 2.3-5.0), sharing of dental cleaning materials (OR = 2.5, 95% CI 1.3-4.6), and biting of fingemails in conjuction with scratching the backs of carriers (OR = 2.5, 95% CI 1.6-4.3)

So do toddlers share food, spit, drool and slobber on each other?

Being in the same household as a chronic (asymptomatic) carrier increases the risk 10-fold ... vaccination cuts that way of spreading down, cutting the numbers of chronic carriers.

http://www.ncbi.nlm.nih.gov/pubmed/2787161 Just being in the same classroom as an infected student is a risk factor. Vaccinating babies protects their caretakers.

By TsuDhoNimh (not verified) on 10 Mar 2010 #permalink

Chris (#45): There's also a relationship between a kid's race, socioeconomic status, and the diagnosis he's likely to get (all other things being equal for the same symptoms). Poor or black people are more likely to get diagnoses that a) aren't seen as grounds for providing expensive services and b) tend to be treated with medications that can also be used as chemical restraints.

Philip @ 45:
As to your first point let's consider Hepatitis B, a blood borne or sexually transmitted disease.

As Chris explained beautifully at 46, "blood borne" means it is a very serious threat to children. It also means it is a very serious threat to childcare providers; there is a reason why daycares, schools, and even Cub Scout den mothers have to prove they know how to handle blood -- it's because of hepatitis.

In other instances, such as influenza, the vaccine often contains a preservative that has been banned in much of the world over toxicity concerns, has no good US toxicology data and is 49% by weight ethyl mercury.

First off, you seem to be tarring all vaccines because of thimerosal, despite the fact that most do *not* contain it. Thimerosal was removed from all of the mandatory childhood vaccines in the US years ago. Interestingly, the autism rate was unaffected by this, though the price of vaccines was affected -- single-dose formulations are always more expensive, for reasons which should be obvious. (That's a lot of syringes to load right at the factory.)

Not even all influenza vaccines contain thimerosal. Flumist does not (and cannot; it's a live virus vaccine), and inactivated flu virus vaccines are also available in single-dose preparations.

Secondly, you say that thimerosal is 49% ethylmercury by weight. You're confused; it's sodium ethylmercurithiosalicylate, which in turn is 49% mercury by weight. (Ethyl mercury is what thimerosal metabolizes to in the blood.) But that's really not as important as you might think. First, as pointed out above, ethyl mercury is a compound; if you are afraid of it because of the word "mercury", you should also be afraid of table salt. Secondly, it's not as deadly as you think. Ethyl mercury has a half-life in the blood of 18 days in adults -- but interestingly, only 3.7 days in infants. (Methyl mercury, on which all the safety guidelines are based, has a half-life of 44 days. Straight mercury has a half-life of 120 days, which is much more serious.) But most importantly, while you are expressing the scary "thimerosal is 49% mercury statistic!" you are ignoring the rather more important question of how much thimerosal is in the vaccines in the first place. 49% of a tiny amount is still tiny.

So how tiny is the amount? I looked up Fluzone. This is available in three prefilled thimerosal-free versions (three different ones to cover three different doses; children receive a smaller dose) and in a 5mg multi-dose vial. The multi-dose vial contains thimerosal, because the risk of infection is far greater than the risk of harm from the preservative. It contains 25 mcg per vial. The LD50 for thimerosal given intramuscularly to a rat is 30 mg per kg. (LD50 is a standard measure of toxicity; it's what kills 50% of the test subjects.) Extrapolated to a young child weighing, say, 20 kilos, and you get an LD50 of 600 mg (.6 grams). One milligram is of course 100 micrograms, so the LD50 is 2,400 times the dose in an *adult* influenza vaccine.

In the case of gardasil there have been a tremendous number of serious adverse events while one must suppose, without data that immunity would last decades to be efficacious, certainly a rarity in any previous vaccine.

A rarity? Many vaccines produce long-term immunity. Not all do, true. But you seem to use the word "many" in a very difference sense then you use the word "tremendous" within the same sentence. I am not aware of a tremendous number of serious adverse events related to Gardasil. I am aware of a few deaths that occurred after taking it, but which were not linked to the vaccine itself. (Be ware of the post hoc, ergo propter hoc fallacy -- people get sick and die, and it isn't always because of something that happened shortly before. There needs to be evidence to link the two.)

If a vaccine manufacturer harms you with a vaccine (unless you wish to argue they are 100% safe) they are "immune" from liability. This is a stupid and unwise idea.

Yes, that would be a stupid and unwise idea. Fortunately, it isn't true -- manufacturers are most certainly not immune from liability. There is a Vaccine Court, but if you are harmed by a vaccine, you are allowed to pursue satisfaction in the civil court system if the vaccine court does not produce a settlement to your liking. Indeed, some people have done this.

Liability isn't the only thing they have to worry about. They also have to worry about regulation. The FDA and the CDC are both involved in vaccine manufacture; the FDA's aim is to ensure they are safe and effective, while the CDC's aim is more epidemiological -- they want to make sure the right vaccines are being made in adequate quantities to achieve the desired effect. The FDA can and does action. Vaccines have been recalled before.

Of course vaccines are not 100% safe. But they're damn close to it, closer than a hell of a lot of other things in life which we accept without a second thought.

By Calli Arcale (not verified) on 10 Mar 2010 #permalink

In addition to the previous comments, one point that bears mention:

In other instances, such as influenza, the vaccine often contains a preservative that has been banned in much of the world over completely unfounded toxicity concerns, has no good US toxicology data and is 49% by weight ethyl mercury.

There was never any real reason to worry about thimerosal.


Good job cribbing the AntiVax Talking Pointstm! I'm sure J.B. and the folks back at Generation Rescue Presented By Jenny McCarthy have a gluten-free cookie waiting for you. Make sure you thank SPC for the treat.

One thing I've never understood about the people who complain about hepatitis shots at birth, when it's sexually transmitted and babies aren't having sex - isn't the process of being born likely to expose you to an STD your mother may have? All the births I've witnessed have involved the baby being exposed to a vagina. And they involved an awful lot of blood, too. I assume that c-sections also involve blood and other major body fluids, though I've never seen one myself. Are people that unfamiliar with birth that the concept of an STD being transmitted during it doesn't even occur to them? Or is this just putting mothers up on a pedestal of purity, who could never even possibly be unknowing carriers of anything dirty? Or are hepatitis tests such a routine part of prenatal care for the worrying class that it is assumed to be universal? (I've always been under the impression that extent of prenatal care is class-based in the US, like much of health care.)

I just can't understand why someone who has so obviously been exposed to a vagina, forget about one that likely experienced a lot of tearing, etc., wouldn't be considered at risk for catching something we think of as an STD. At least by anyone even vaguely familiar with the process of mammalian birth.

@Djinna: There is a lot of blood with any birth, along with amniotic fluid, mucus, etc. ALL body fluids that a baby is exposed to. (Amniotic fluid may be sterile, in that outside bacteria don't usually enter it until the membranes rupture, but that does not preclude fetal exposure to maternal disease which crosses the placenta).

As far as pregnancy care in the US: in a sense, yes, it is class based. But as a midwife who has worked with all sorts of clients, I can tell you that any woman who shows up for prenatal care is tested for Hep B (along with many other things...blood type, anemia, diabetes depending on how far pregnant she is). Even if a woman shows up at a hospital in labor, she will be tested for Hep B (along with HIV, frequently). Midwives who do home births usually have their clients tested also, for the "routine" labwork. However...all the result documents is mom's current/previous status as of the blood draw. It does not reflect, in a woman who is tested early in pregnancy, that maybe she got Hep B late in pregnancy. And, as you say, the baby is exposed to a fair amount of body fluids at delivery (so is the hospital staff, although they wear gloves...the baby doesn't!)

To clarify, the Supreme Court case is not about the Constitution. It is about the statue Congress passed and how it should be interpreted.