Wyeth Can Be Sued For Thimerosal In A Vaccine
28 CommentsBy Ed Silverman // October 7th, 2008 // 10:04 am
The Georgia Supreme Court has allowed an Atlanta couple’s lawsuit against Wyeth to proceed, upholding a first-of-its-kind ruling by an appellate court that had drawn fierce opposition from the vaccine industry, The Augusta Chronicle reports.
The court’s unanimous decision Monday concluded that a 1986 federal law that has been used to block other suits against vaccine makers does not bar the suit from Marcelo and Carolyn Ferrari from going to trial, the paper writes. (Here’s the decision).
The court upheld a ruling by the Georgia Court of Appeals, which became the first appellate court in the nation to hold that the National Childhood Vaccine Injury Compensation Act does not preempt state law. The Ferraris asked the Georgia Supreme Court to rule that Wyeth can be held liable for damages in a civil case involving their son, Stefan.
The family believes they can prove thimerosal, the mercury-based preservative, caused their son’s disability. Stefan, they maintain, was a talkative toddler before he got a round of boosters shots when he was 18 months old, according to the paper, adding that the boy, now 10, hasn’t spoken since.
Seven other state courts have ruled federal law preempts state law that might give families the power to challenge vaccine makers. But the Georgia Court of Appeals became the first appellate court to rule federal law doesn’t take precedence over state tort rules, calling the federal statute unclear, the paper notes.
The case has drawn protests from the vaccine industry and powerful lobbying groups from the U.S. Chamber of Commerce to the conservative Pacific Legal Foundation.
At hearings in May, Wyeth attorneys argued that other judges have concluded Congress wanted the federal law to pre-empt state rules, in part so that manufacturers aren’t subjected to a mishmash of different state standards (back story).
Wyeth spokesman Doug Petkus tells the paper the company would appeal the decision to the US Supreme Court. He adds that other courts have agreed that federal law supersedes state claims for injuries if the vaccines are prepared with FDA-approved designs and are accompanied by the proper warnings.
The Ferraris’ attorney, Lanny Bridgers, contended that federal law was meant to supplement, not displace, state law.
The Georgia Supreme Court’s ruling, written by Justice George Carley, says the federal law “does not preempt all design defect claims against vaccine manufacturers.”
Instead, the court held, vaccine manufacturers must prove on a case-by-case basis that the side effect of the particular vaccine were unavoidable to be immune from defective design claims.
Families have claimed in court that thimerosal is linked to autism, although government lawyers say the Centers for Disease Control and Prevention has rejected any link.
Anon
“Instead, the court held, vaccine manufacturers must prove on a case-by-case basis that the side effect of the particular vaccine were unavoidable to be immune from defective design claims.”
Holy crap! This is lunacy. Isn’t the burden of proof supposed to be on the plaintif? This statement makes is sound like vaccine manufacturers are guilty until proven innocent!!! I’m glad the rest of our legal system doesn’t work that way. To bad that pharma seems to be an exception to the rest of our legal system…
Nathan
Woops — that last post was from me, sorry!
nhokkanen
Thousands and thousands of parents’ vaccine injury reports ignored. That’s what brought us to this — a failure of proper post-marketing surveillance. You can buy a vacuum cleaner bag at Wal-mart and get better customer service if something goes wrong. Instead Pharma and CDC play ostrich, physicians look the other way, the media parrots PR bullet points, and online crusaders claim that as long as benefits outweigh risks, vaccine injuries should continue. Imagine if we ran school buses like the vaccine program. If the bus driver runs over a few kids at the school, the administration issues a press release counting how many kids are still standing.
Nathan
nhokkanen,
You are comparing vaccine treatment to riding on a bus?? It’s a little more complicated than that… Buses just transport people — they don’t save people.
A much better analogy is air bags in cars. Sure, you can complain about all the people that air bags have killed. But it’s perfectly appropriate for the manufacturer of air bags to brag about how many lives they have SAVED in the process.
The bigger issue is Ed’s statement above: “the court held, vaccine manufacturers must prove on a case-by-case basis that the side effect of the particular vaccine were unavoidable…” THIS IS NOT THE LEGAL SYSTEM THAT WE HAVE IN THE US. WHAT HAPPENED TO INNOCENT UNTIL PROVEN GUILTY?
anonymous
Pharma is going down. They will need a bigger bailout than Wall Street. The absolute lunacy of injecting mercury into the human body will be revealed. How can they even defend this. I suggest they settle.
B. Martin, MD
The issue considered by the Georgia Supreme Court is the issue of pre-emption, not whether thimerosal is linked to autism (which it is not). From what I can tell, the courts did not consider the plantiffs’ causation argument. The latest decision is really a punt up (yet another one) to the US Supreme Court on pre-emption.
It should be noted that the Ferraris have cast a very wide litigious net, alleging mercury poisoning by a large number of companies–including 8 vaccine manufacturers, 8 thimerosal manufacturers, 1 rhogam manufacturer, and Georgia Power (claiming mercury emissions from power plants injured their son).
Mr. atoz
And how much mercury do you think enters your body from the food you eat? Especially from deep sea fish like tuna. Much more than the amount in the vaccine. The pharma companies must be deliberately poisoning people. That’s how they’ve managed to stay in business over a century.
rodmac
I find much of the information on The National Autism Association web site regarding thimerosal fascinating and compelling. This is anything but a lunatic fringe group looking for conspiracies under the bed. Further reading has me convinced that a lot of good research is being ignored or worse, while bad research is being trotted out to serve as industry/FDA/CDC PR for thimerosal-containing vaccines.
According to Boyd Haley, a University of Kentucky biochemist and one of the world’s top experts on mercury toxicity, “… the association between the use of thimerosal and autism has moved from biologically plausible to a biological certainty.
Lots more here: http://www.nationalautismassociation.org/thimerosal.php
rodmac
I also want to point out this info, from a NYT article a few months ago:
“The disease control centers, the Food and Drug Administration, the Institute of Medicine, the World Health Organization and the American Academy of Pediatrics have all largely dismissed the notion that thimerosal causes or contributes to autism.
“Five major studies have found no link, and since thimerosal’s removal from all routinely administered childhood vaccines in 2001, there has been no apparent effect on autism rates.”
Of course the writer used the word “largely”, which means there still is not a consensus.
rodmac
It’s the date-time coincidence of onset of neurological problems and vaccinations that has people looking for a connection, and thimerosal was the most likely suspect because of known mercury toxicity. But the Hannah Poling case (http://www.nytimes.com/2008/03/08/us/08vaccine.html?_r=1&oref=slogin) shows a completely different connection. Perhaps the thimerosal proponents would do well to expand investigations beyond thimerosal.
physician
As per B. Martin, MD; the case truly focuses on state rights, and no surprise that it comes from a state with a long history on this battleground (remember the confederate flag controversy). The appellate court has made no statements on the merits of the case, i.e. the putative link made by the plaintiffs between exposure and outcome, but rather on the right of the state to overrule federal policy. State rights have always provided fodder for the legal system as our republic structure maintains the tension/balance of local vs. national rights and responsibilities. Theoretically, one could trace this to the origin of the country itself wherein the contemporaneous equivalent of a state, the colonies, fought the then national goverment, England, over taxation rights.
Nathan
I’m still waiting for any comments on Ed’s quote: “the court held, vaccine manufacturers must prove on a case-by-case basis that the side effect of the particular vaccine were unavoidable”
Doesn’t this strike ANYONE as being out-of-whack? Maybe this was a case of just an out-of-context quote, but this statement doesn’t seem correct at all. The plaintiffs should have to prove that the side effect was due to intent or negligence, right? The burden of proof should never be on the defendant.
petmc
Boyd Haley is controversial at best. Many scientists consider him a quack with a vested interest (e.g. selling test kits to identify toxins that require removal and then selling treatments). His science is loose at best. Hardly what one would consider a top scientist or even universally respected. Scientists respect good science method even if views conflict or interpretations are not agreed with. The one thing scientists abhor is poor experimental design, and over-reaching claims. Nothing is certain in science only supported.
B. Martin, MD
Nathan,
The statement in question may be a journalistic interpretation of the decision, and not part of the decision itself–which can be found at http://www.gasupreme.us/pdf/s07g1708.pdf. Relevant statements in the decision include, “…we nevertheless
affirm the judgment of the Court of Appeals because a full examination…shows that the Vaccine Act does not preempt all design defect claims, but instead provides that a vaccine manufacturer cannot be held liable for defective design if it is determined, on a case-by-case basis, that the injurious side effects of the particular vaccine were unavoidable.” This statement refers to when a vaccine manufacturer may be held liable, but it does not indicate that the burden of proof is on the defendant (eg, a vaccine manufacturer) in a civil liability case. At least that how I read it.
Robert Krakow
As to the comment about Boyd Haley made by petmc:
Dr. Haley is a respected chemistry professor at the University of Kentucky and for a long time served as Chair of the university’s Chemistry department. Your claim that he is “selling test kits” and “selling treatments” is completely without support. I would be interested in your basis for these statements that verge on slander.
Dr. Haley has numerous publications in the scientific literature and invented a laboratory testing technique that is widely used in university and government labs. Your suggestion that he employs “loose” science or that his work “lacks good scientific method” is meritless.
You and others may find Dr. Haley’s views disagreeable because it challenges conventional belief, but if you wish to challenge Dr. Haley’s work it would serve you better to do so based on supported fact and principled arguments rather than slinging second-hand mud. Dr. Haley is a magnet for such attacks because he is willing to speak out about the dangers of mercury, to his own detriment, I should add.
As for Nathan’s complaint that the Ferrari decision is out of “whack” please consider the procedural context of the decision. The Georgia Supreme Court has not decided the merits of the claim that thimerosal causes autism (B Martin MD is correct in his post) nor is it shifting the burden of proof. All the court has said is that Congress through the vaccine act did not say that suits alleging design defects or failure to warn claims are barred in the states. Whether or not a case may proceed in the states must be determined on a case by case basis. Judge Carley quotes specifically to the vaccine act’s legislative history in support of this holding.
The burden of proof remains on the Ferrari’s to prove that there existed a design defect and that the defect was avoidable. All the court is saying is that the Ferraris can sue in state court. While your confusion about this is understandable your concern is misplaced.
I think Rodmac correctly points out that there exists a great deal of sound science that supports the theory that thimerosal causes autism. Much of this credible science was presented last June by attorneys for petitioners in the thimerosal test case pending before the U.S.Court of Federal Claims, where more than 5000 petitioners have filed claims.
On the “5 large studies” cited by the New York Times, there exist serious flaws in these studies. In fact, at the thimerosal test case hearing one of the world’s leading epidemiologists testified under oath that the epidemiological studies that exist have not even looked at the core issue in many cases - whether cases of “regressive autism” - where normal developing children rapidly lose skills such as speech - is caused by vaccines or its components, including thimerosal. Thus, there are no useful studies that have examined this critical issue.
The Hannah Poling case did inject a new factor into the controversy, i.e., whether or not a preexisting mitochondrial dysfunction was aggravated by vaccines, ultimately causing autism. But even in that case - conceded by the government based on a review by medical experts at the Dept. of Health and Human Services - there is a claim supported by petitioners’ experts that thimerosal in vaccines was the agent that caused an aggravation of the preexisting condition. There is no dispute in that case that vaccines significantly aggravated Hannah’s condition and cause “autistic like symptoms.” Under the prevailing definitions (the DSM-IV) there is absolutely no distinction between autism and “autistic like symptoms.” Hannah was diagnosed with autism and it is the vaccines, all agree, that triggered, caused, or aggravated - choose your word - her regression and illness.
Finally, atoz suggests that much more mercury enters the body from food than from vaccines. While this may be true today it likely was not true through at least 2003 when children routinely received more than 237 micrograms of mercury by age two through vaccines. Credible estimates contained in the literature suggest that a child received approximately 50% of their mercury exposure through vaccines. You need to consider in this regard the route of exposure (injection circumventing the body’s detoxification defenses through the gi system) and the fact that vaccines contained “bolus” exposures (one time large - relatively speaking -rather than incremental exposure.) Such exposures are not as easily handled by susceptible children as the more incremental ones. You also need to consider that exposure to toxins like mercury is cumulative. In fact, the more exposure that exists, including some mercury that invades the brain and may remain there almost permanently - the more the body burden is increased and the child’s detoxification system is disabled. Thus background exposures from food, or the air set the table for the vaccine bolus doses which can put children over the edge - the “tipping point” - into disease.
I hope some of this clears up misconceptions about vaccine/autism claims and the legal developments that have occurred. It is a complex area that requires close study.
Disclosure: I am a parent of a child who has a claim pending in vaccine court and I am a lawyer representing children with such claims.
Laurie
The core issue is that vaccines were originally created in the hope that they would provide immunity during the time of EPIDEMICS. They have never actually been proven to work, however side effects are better documented than any proof of their effectiveness. During an epidemic, they might be worth the risk. All we have now is an epidemic of autism and other vaccine-related damage. In a recent school outbreak of measles, for example, over 60% of those affected had been vaccinated! The polio epidemic of the 1950’s was almost over when the polio vaccine came out — today virtually all polio cases are the result of the vaccination. The pharma companies are making winfall profits from the sale of vaccines. Government has an obligation to protect its citizens: not the profits of privately owned cartels.
Nathan
Laurie —
Are you the same Laurie who typically posts on this site? You should have kept your mouth closed - I used to respect your opinion a little more. That post was right up there with some of Truthman’s claims! Let’s take them one-by-one:
“[Vaccines] have never actually been proven to work” Huh? Are you kidding me?
“side effects are better documented than any proof of their effectiveness” Side effects are well documented for ALL drugs — not just vaccines. You never see the kids who avoided getting ill — you only see it by analysis of statistics.
“In a recent school outbreak of measles, for example, over 60% of those affected had been vaccinated!” I’d like to see the link for that. The recent outbreaks in the UK have been amoung people who have NOT been vaccinated. Moreover, there are
immuno-compromise children and adults who are put at risk when healthy children go unvaccinated. In an outbreak in the 1980’s, there were 50,000 measles cases and 123 deaths. See this link:
http://www.courier-journal.com/apps/pbcs.dll/article?AID=/20080925/FEATURES03/809250314
“All we have now is an epidemic of autism and other vaccine-related damage.” I guess I now know where you come down on this issue. You disagree with nearly every scientific body out there, including the FDA and the APA. One of the authors of the study that originally made the link has been unable to reproduce his own work! This theory is (thankfully) dying out. See the below link and see the story that Ed wrote a few weeks ago:
http://biotech.about.com/b/2008/09/30/measles-vaccine-and-autism-link-disproved.htm
“today virtually all polio cases are the result of the vaccination”. Again, I want to see some evidence here. I don’t believe that statement what-so-ever.
“Government has an obligation to protect its citizens”
I agree — hence we have mandatory vaccinations. Fortunately, the government listens to genuine science that is published by reputable scientists in reputable journals. You evidently do not.
anonymous
Vaccines are a big scam and unfortunately many children have paid the price of their health for this vaccine scam. Thimersal has never been safety tested on infants or children- Only adults dying of meningitis. Guess what - they all DIED.
I heard on the news today that the flu shot is ineffective but go ahead and get it anyway. huh? Pharma logic.
truthman30
“That post was right up there with some of Truthman’s claims!”
Shut up Nathan….
truthman30
My claim’s are all based on research , knowledge and FACTS…
B. Campaigne
So, to all the pro vaccination cheerleaders out there….
What does cause Autism?
Please explain in a million words or less.
judy
I truly hope this is not the beginning of a trend. vaccines not only save lives, but they save tons of money and health care resources in the treatment of vaccine-preventable diseases. The reason the Vaccine Compensation Fund was created by the federal government was to keep people from suing the pharma companies directly. Pharma will not produce vaccine if it is not profitable and we needs vaccines to keep our communities healthy and health care expenditures down. This could be a pretty slippery slope and I hope that judge realizes it.
Dad Fourkids
The core issue at this matter is that vaccines manufacturer’s have pressed for protection from prosecution that no other corporation enjoys. The Feds and major medical associations back this because they have vested interests in preserving compulsary vaccination. The philosophy of pre-emption should only come into play where the FDA’s findings have the full backing of science. This is not the case with thimerosal in particular and many medical products in general.
To start with, thimerosal has NEVER been tested for safety in pediatric vaccines, and the same base chemical, ethyl mercury, has been found to be unsuitable for topical solutions such as disinfectants and also as a preservative in eye drops and ear drops. It was “grandfathered” into use when the FDA was formed and allowed to remain even to this day in many vaccines. So the FDA cannot have an opinion on its safety, therefore pre-emption should not hold true.
It is interesting to note that the “5 major studies” which “exxonerate” thimerosal from the autism question were all statistical manipulations conducted by people with a direct interest in not being sued over it’s use (vaccine manufcturers and employees of the CDC). And we all know the veracity of statistics. One of the 5 studies was generated using the VAERs database, which Gerberding stated just this year was such a flawed dataset that no conclusions could be derived from it.
What the IOM and NAS did not consider were several clinical studies which actually examined the biological occurances from the use of thimerosal in vaccination, all of which were consistant with theory of thimerosal triggering autism.
The court was correct in allowing this suit to proceed. If the science will back the plaintiff’s claim, the defense will lose. If the science will not, then Pharma will prevail, and they will have a valuable precedent against any further suits.
But we do have to evaluate the situation honestly, regardless of the fall-out. Thimerosal and autism, should it prove to be true, would only be the latest example of the medical heirarchy defending an unsound situation or practice simply because that is the status quo, and they don’t want to look like they were flying blind.
Nathan
Laurie,
Aren’t you a nurse? Do you advise your patients not to get vaccines? If so, is the doctor you work for aware of this?
Mr. Blue
Nathan, if you’re own ears have heard, in a manufacturing filling area: “everyone knows there is aluminum in vaccines, the trick is to make sure the particles are small enough not to see”, you’d think differently.
Enjoy your flu shot.
laurie
That post is not me…I believe we have a second Laurie on pharmalot. My take on vaccines is…do your research and make your own decisions.
I’ll get in touch with Ed to see what he can do about the duplicate names.
laurie
Nathan, the “Laurie” that posted regarding vaccines has a capitol “L”..mine is lower case.
john q puplic
Until you’ve have had a child that ate, played, and talked normally with you. To having a child that rocks back and forth and only SCREAMS. All within a very short period of time after receiving the MMR shot.
THEN YOU HAVE NO IDEA!!!!
I do…
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B. Martin, MD- whether thimerosal is linked to autism (which it is not).
IT SHOULD BE!!!!!!!!
What studies do you site, gov. sponsored?
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Funny how we can sue everyone else on earth but big pharma. hummmmm
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1 person died of the swine flu in the 70’s
25 died and many more permanently harmed because of the vaccine.
In the mid-1990s, during a period of less than five years, there were
13,641 documented adverse reactions to the oral polio vaccine. 6,364 of
these were serious enough to require hospital emergency room visits. 540
people died.
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The STATISTICAL history of vaccines shows that vaccines have NEVER played a major roll in preventing disease and that mass vaccinations campaigns have more to do with finances than with health!
http://www.rawfed.com/vax/stats.html
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yeah doc & the rest of the brain dead crew might want to read a book or 2………