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Georgia on my mind

Scales

My inaugural post was about vaccines, and I promised that I wouldn’t write exclusively on this topic. But something rotten is brewing in the state of Georgia and this story is just too important to ignore.

The first successful challenge to the National Childhood Vaccine Injury Compensation Act (NCVICA) has taken place in Georgia, and we all should be just a little bit worried. In Ferrari v. American Home Products Corp., the plaintiffs, Marcello and Carolyn Ferrari of Atlanta, have sued American Home Products Corp. (otherwise known as Wyeth) and the co-defendant GlaxoSmithKline, claiming that the vaccine preservative thimerosal led to their son’s autism. The consequences of this ruling could effect the health of the entire nation. To understand why, we need to delve a bit into what the NCVICA is exactly, and why it was created in the first place.

There have been “anti-vaccine movements” ever since Jenner tested the first smallpox vaccine in 1796. But what might be considered the big-bang of the contemporary anti-vaccine movement in this country occurred in 1982, when the documentary DPT: Vaccine Roulette aired on WRC TV. It was a devastating and graphically in-your-face documentary purporting to show the neurologically ravaged child victims of the original whole-cell DTP vaccine. Once this hour-long documentary was aired nationally, the entire country was “awakened” to the alleged dangers of vaccines. Although no good evidence ever surfaced attributing any serious complications to the old whole cell pertussis vaccine, the documentary created massive fear of this vaccine, and widespread mistrust of vaccines in general. A woman named Barbara Loe Fisher was so taken by this show, that she formed an organization, Dissatisfied Parents Together (which later became the National Vaccine Information Center, the largest and best-known repository of vaccine misinformation), whose mission was to lobby the federal government to enact legislation to compensate parents whose children had supposedly been injured by vaccines. In 1986, the National Vaccine Injury Compensation Program (VICP) was enacted by congress as part of the National Childhood Vaccine Injury Compensation Act. The most important purpose of the VICP was to safeguard the nation’s vaccine supply in the wake of a mounting torrent of lawsuits directed at vaccine manufacturers. These lawsuits were a major threat to the country’s vaccination program, as manufacturers faced potential jury awards that would be impossible to survive. In 1979 there was one DTP-related lawsuit. In 1986 there were 255. Between 1983 and 1984, costs related to these lawsuits climbed from $4.7 million to $9.9 million. In 1986 alone, over $3 billion in DTP injury claims were sought, which was 30 times greater than that year’s entire dollar value of DTP vaccine. Vaccine prices soared, and companies stopped making vaccines or went out of business entirely. In 1957 there were 26 vaccine manufacturers. In 1980 there were 17 companies making vaccines, and by 1986 there were only 3 (today there are only 5 major vaccine manufacturers in the world, and they are large pharmaceutical companies for which vaccines are only a small part of their product line).

The VICP effectively saved the nation’s vaccine program by moving these legal actions out of the traditional tort process, and creating a no-fault system whereby the vaccine manufacturers were saved from potential ruin. A special “vaccine court” was created to hear injury claims, presided over by Special Masters responsible for reviewing the evidence and quickly adjudicating cases on behalf of claimants. If a parent’s claim is deemed to fit a known vaccine complication, an award is usually given without significant reliance on the customary rules of evidence required by the traditional tort system. Compensation is drawn from a fund generated by a 75 cent excise tax on each vaccine component at the time a vaccine is administered (75 cents for a single vaccine like Hepatitis B, $2.25 for a three component vaccine like DTP).

While the VICP has been successful in providing timely compensation in cases of true (but rare) vaccine injury, the emphasis on streamlined proceedings, and the lack of rigor and evidence-base required of science (these are, after-all, legal not scientific hearings) has resulted in many rather dubious rulings. The special Omnibus Autism Proceedings, discussed previously on SBM, was established as an extension of the original vaccine court, and was designed to handle the over 5000 lawsuits clogging the system from parents claiming their children developed autism as a result of the MMR vaccine, the thimerosal preservative in other vaccines, or a combination of these factors. I’ll refrain from discussing the science behind this here, as it has been extensively covered elsewhere. Suffice it to say that the Special Masters poured over mountains of published evidence and listened to hundreds of hours of testimony on three test cases for these three theories. In a victory for science, they ruled strongly and unanimously against the claimants. This time, at least, the legal system respected the science and made it’s ruling accordingly.

Back to Georgia.

What’s brewing in the state of Georgia right now should bring a chill to the spine of anyone familiar with the history of the legal threats to our vaccine supply. For the first time since the creation of the VICP, and with complete disregard for the intent of Congress, a product-injury lawsuit against a vaccine manufacturer has been allowed to go forward.

In 2005, Marcelo and Carolyn Ferrari sued American Home Products Corp. (aka Wyeth) and GlaxoSmithKline claiming that thimerosal in the vaccines their son received caused his autism [it is interesting to note that they also sued the local power utility, claiming that their mercury emissions contributed to his autism as well]. A Georgia state court correctly ruled, just as all other courts have done previously, that the Ferrari claim was pre-empted by the congressionally enacted VICP. The Ferrari’s appealed, and won a reversal from the Georgia Court of Appeals in 2007. Incredibly, the appeals court ruling was upheld by the Georgia Supreme Court in 2008, effectively clearing the way for a return to the days when a flood of law suits threatened to undermine our Nation’s vaccine supply. The judge in the Georgia Supreme Court’s ruling interpreted the Vaccine Act by stating:

…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.

Forget the fact that autism has never been an “injurious side effect” of vaccines, whether they contained thimerosal or not. These are legal proceedings, having nothing to do with causation. [It does, however, make it difficult to follow from a rational, evidence-based perspective.]

The judge further held that,

…if such effects were avoidable by a feasible, alternative design, liability is not completely barred.

In the Ferrari case, the court thus found that the plaintiffs should be allowed to make a claim based on the presumption that their child’s injuries may have been avoidable with a different product design, and that that decision should be left to the trial courts to decide, congress be damned.

But the judicial precedent of state courts following the intent of congress is well established. In fact a recent ruling by the Third Circuit (regarding another vaccine liability case) specifically cited and rejected the Georgia Supreme Court’s ruling in the Ferrari case, stating that 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.” And “Each of the objectives extolled [in the Vaccine Act's legislative history] would be undermined.”

The Third Circuit court judge clarified the intent of congress by stating that the Vaccine Act pre-empts

all design defect claims, including those based in negligence.”

But the Georgia Supreme Court’s ruling in favor of the Ferrari’s flies in the face of Congress’ intent when it enacted the VICP.

The legal reasoning as to why this decision is not legitimate is more complex than I’ve laid it out to be here. The bottom line is if the decision is allowed to stand, the floodgates will once again be opened to a torrent of litigation that could cripple the vaccine industry, just as we saw occur in the mid 1980′s, potentially lowering vaccination rates and leading to a resurgence of vaccine preventable disease.

Last month the American Academy of Pediatrics filed an Amicus Brief with the U.S. Supreme Court, asking that it overturn the lower court’s ruling. The brief was co-authored by the American Academy of Family Physicians, the American Medical Association, the American Public Helath Association, Every Child By Two, the Immunization Action Coalition, the Infectious Diseases Society of America, the Pediatric Infectious Disease Society, the American College of Osteopathic Pediatricans, and the Vaccine Education Center of the Children’s Hospital of Phildelphia. In the brief, the AAP argues that vaccines have been one of the most important public health measures of the twentieth century. In it’s brief, the AAP goes on to elaborate about the dangerous precedent the Ferrari ruling makes, and reminds the court how vulnerable our vaccine supply is to an unregulated tort process. It points out how the Vaccine Act has not only allowed vaccine manufacturers to continue to make vaccines, but has allowed for the continued development of extremely important vaccine products. Despite this, we have not seen a rise in the number of companies in the business of making vaccines. Because of this, the current vaccine supply remains highly susceptible to a return to the old wild-west style of vaccine litigation that existed prior to the Vaccine Act. Currently, there are only two manufacturers of the DTaP vaccine in the United States. Only one company makes the MMR vaccine. A dramatic illustration of the vulnerability of our vaccine supply resulting from the difficult financial pressures on vaccine production can be found in our current shortage of Hib vaccine.

There are two US makers of the Haemophilus influenzae type b vaccine. Because of a quality control issue, one was forced to stop production of the vaccine while it retools it’s manufacturing facility. The remaining Hib manufacturer has been unable to keep pace with production, resulting in a nationwide shortage of the vaccine. This prompted the CDC to recommend a temporary change to the Hib vaccine schedule, holding the booster dose usually given at 15 months of age. This shortage, combined with an increasing prevalence of parental vaccine refusal due to the spreading wave of vaccine misinformation, has resulted in the frightening emergence of isolated Hib outbreaks. Four children have died.

The future of the vaccine supply is now in the hands of the US Supreme court. If the Ferrari lawsuit is allowed to proceed, vaccine manufacturers will once again be open to an onslaught of hungry trial lawyers and an enormous pool of misinformed parents eager for revenge. Our greatest weapon against childhood death and disease will fall prey, but our children will be the ultimate victims.

Posted in: Politics and Regulation, Public Health, Science and Medicine, Vaccines

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16 thoughts on “Georgia on my mind

  1. David Gorski says:

    I hate to be pessimistic, but the outcome may not matter anyway.

    Parents still have the right to sue in civil court if they lose a Vaccine Court ruling. The law only says that they have to go through Vaccine Court first. Many of the parents in the Autism Omnibus ruling stated quite openly that they planned on bringing civil suits if the Omnibus failed. Well, the Omnibus failed, and it won’t surprise me if there is soon a tsunami (if you’ll excuse the term) of Omnibus cases flooding civil courts that, win or lose, frivolous or not, will cost companies more to litigate than all the profits of all the vaccines in our current childhood vaccine schedule combined.

    I fear that the anti-vaccine movement will only be stopped when deadly vaccine-preventable illnesses return with a vengeance, and there are no vaccines to be had because lawsuits have driven pharmaceutical companies out of the vaccine business. In this worse case scenario, only then will public opinion turn against the anti-vaccine movement to the point where parents clamor for vaccines to protect their children, as they did in the age of polio. I hate to be pessimistic, but that does appear to be the way things are going. I had a brief spike of optimism after the revelation that Andrew Wakefield is a fraud and the resounding rejection by the Special Masters of the arguments made in the three test cases in the Autism Omnibus, but that only temporarily slowed down the anti-vaccine movement. Now it’s back with a vengeance, with Oprah supporting Jenny McCarthy by hiring her to do her own show and multiple media projects.

    The anti-vaccine movement is well-funded, full of celebrity airheads to support it, and, for the moment at least, vaccines have been so effective that too many parents fear the vaccines more than they fear the diseases they prevent.

  2. tmac57 says:

    I think it is time for parents of children who have been harmed by contracting vaccine preventable diseases because of specific examples of willful negligence by other anti-vaccine parents to bring their own lawsuits. They should go after the anti-vaccine organizations who have spread false and misleading information that have caused parents to fear vaccines,causing this current hysteria.

  3. Anne B says:

    Dr. Gorski is right — the petitioners in the compensation program have the right to pursue tort claims if they don’t like the result they get in the Court of Federal Claims.

    The petitioners also have the right to withdraw their petitions and pursue tort claims if their petitions aren’t resolved within the time limits set forth in the Act. All the autism petitioners got notices from the Court of Federal Claims that they had the right to withdraw, because the autism cases dragged on so long. They elected to stay in the compensation program, though. For now.

    It’s clear to me that Congress never intended to foreclose completely the petitioners’ ability to assert tort claims outside the program. In fact there were a couple of recent thimerosal cases in Maryland – Skevofilax and Blackwell – but they never even got to ttrial.

    In Skevofilax, the plaintiffs weren’t able to present any expert testimony so the trial court granted summary judgment in favor of the defendant. In Blackwell, the trial court excluded the testimony of the plaintiff’s expert witnesses, Dr. Mark Geier, Dr. Stephen Siebert, Dr. Elizabeth A. Mumper, Prof. Richard C. Deth, and Prof. Boyd E. Haley, and then granted summary judgment for the defendants. In excluding the expert testimony, the court said:

    “[I]t is generally accepted in the relevant scientific community that autism is genetic in origin except in rare instances of prenatal exposures to certain substances at defined periods during pregnancy… [I]t is generally accepted in the relevant scientific community that thimerosal in vaccines does not cause or contribute to neurodevelopmental disorders such as autism.”

    Kathleen Seidel of Neurodiversity.com wrote about the case here and here.

    If the results so far are any indication, if the VICP autism petitioners file tort claims, they’ll be lucky even to get their cases in front of a jury, let alone to win multi-million dollar jury verdicts. But I don’t think Congress meant to preclude them from trying.

  4. Khym Chanur says:

    Parents still have the right to sue in civil court if they lose a Vaccine Court ruling. The law only says that they have to go through Vaccine Court first. Many of the parents in the Autism Omnibus ruling stated quite openly that they planned on bringing civil suits if the Omnibus failed.

    But isn’t it easier to win in the Vaccine court? Wouldn’t lawyers who take cases on contingency refuse to take a case that’s already lost in a venue where winning cases is easier, thus forcing all plaintiffs to pay out of pocket? That should result in a lot fewer lawsuits.

  5. John Snyder says:

    David and Anne: It is true that petitioners may reject the judgment of the Vaccine Court, but they may then pursue only limited claims in civil court, and they cannot be design defect claims.

    The bottom line is, the VICP has been hugely successful in reducing the legal burden on vaccine manufacturers, and has been instrumental in keeping our nation’s vaccine supply flowing. If the Supreme Court fails to reverse this decision, there is no question we will see a huge bump in suits filed in state and federal court. Regardless of whether these cases are successful, the damage to our vaccine program could be substantial.

  6. SF Mom and Scientist says:

    Dr. Gorski, I heard about Jenny getting her own show, sponsored by Oprah, but I was really hoping it was just a rumor. This is terrible. So many people follow what Oprah says. People were scared of the swine flu, but that was nothing compared to the disease outbreaks we have ahead of us.

  7. John Snyder says:

    As for congress’ intent, the vaccine act clearly states:

    No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death. . .after [Oct. 1, 1988] 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.

    And legislative history makes congress’ intent equally clear. Prior to the Ferrari deciscion, every court has interpreted the Vaccine Act’s preemption clause as absolute (Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 299-302 (E.D. Pa. 2007); Blackmon v. American Home Products Corp., 328 F.Supp.2d 659, 663-66 (S.D. Tex. 2004); Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 843 (N.Y. Sup. 2003), aff’d, 810 N.Y.S.2d 506 (N.Y.A.D. 2006)).

  8. overshoot says:

    The bottom line is if the decision is allowed to stand, the floodgates will once again be opened to a torrent of litigation that could cripple the vaccine industry, just as we saw occur in the mid 1980’s

    Well, that is the objective after all.

    potentially lowering vaccination rates and leading to a resurgence of vaccine preventable disease.

    I’m sure that there’s a homeopathic remedy for that. Not to mention boatloads of money to be made from selling “dietary supplements,” such as those sold by Boyd Haley.

  9. Esattezza says:

    So, this is both a pleasant thought and a serious question. Could the vaccine manufacturers sue the Jenny McCarthy’s and J.B. Handley’s of the world for slander/libel?

  10. Versus says:

    I think, but I’m not sure, that the attorneys get paid win or lose in the “vaccine courts,” which would make that a an attractive venue.
    Plaintiffs’ attorneys are going to have a hard time getting their “expert” testimony into evidence in state or federal trial courts. I imagine as more cases are lost fewer will be filed as the plaintiffs attorneys won’t be getting paid for losing. If there are a number of cases filed in federal court, the federal district courts might force all of the cases into one district court as multi-district litigation — which is what happened in the breast implant litigation, where a judge appointed an expert panel to review the evidence and all the cases were dismissed (or maybe summary judgment granted to the defendants — I can’t recall).
    In the Ferrari case, Wyeth has filed a petition for certiorari, that is, a petition asking the US Supreme Court to hear the case, but the Court has not ruled on the petition. If the Supreme Court denies the petition the Georgia Supreme Court ruling will stand.

  11. Versus says:

    Re: defamation suit — Vaccine Makers v. McCarthy et al. Yes, I think they may have sufficient factual basis to bring suit. However, that might be a dumb PR move, as that will only increase claims by Jenny & Co. that they are being victimized by big Pharma and give her and friends a bunch of free publicity. I imagine their legal budget is best spent on winning the vaccine cases.

  12. David Gorski says:

    I think, but I’m not sure, that the attorneys get paid win or lose in the “vaccine courts,” which would make that a an attractive venue.

    You are correct. In Vaccine Court, the government pays legal fees and all “reasonable” costs for claimants to prepare their cases, including expert witnesses, etc. Kathleen Seidel has written extensively about this and how one lawyer in particular, Clifford Shoemaker, has made a nice cottage industry out of bringing cases before the Vaccine Court:

    http://neurodiversity.com/weblog/article/149
    http://neurodiversity.com/weblog/article/190

    Indeed, the claims of lawyers representing claimants have gotten so outrageous that even the Vaccine Court is balking:

    http://neurodiversity.com/weblog/article/188/

    She also has a one-stop shopping link for pretty much any information and transcript from the Autism Omnibus that anyone might want:

    http://neurodiversity.com/weblog/article/189/

  13. Esattezza says:

    Versus, I see your point. Problem is, unless there’s a lawyer out there willing to do this pro bono (which would be HUGE), no parent is going to be able to financially stand up to Generation Rescue et al. (heh… “you know you’re a science nerd when…”).

    Of course, there are plenty of people and organizations that would be willing to help out any family up for the fight. However, as soon as that family is backed by Paul Offit, the Autism Science Foundation, or a pharmaceutical company (or Steve, or Dr. Gorski, or…. or… sorry to anyone with the honor of being despised by anti-vaxers that I may have left out), the anti-vax movement gets nearly as much ammunition from that fight as they would if Wyeth sued Jenny.

    It literally makes me feel sick to think that it will take a rise in infant death rates for these people to shut up. Isn’t it enough that we already see it happening in parts of Australia? Do these people all think the reports coming out of there are propaganda to rival the moon landing?

    Heck, I’d become the poster child for science-based autism in the media if I could. Alas, I’m just a grad student, who listens to me? I’m too old to play the “cute little kid card” and apparently too young to know better. (See my blog for details on THAT argument: http://esattezza.wordpress.com/2009/05/01/youthful-naivety/)

  14. SGNeill says:

    As a lifelong Georgian, it disappoints me that this sort of thing came out of my beloved state. To be honest, we’re not the best when it comes to science, or most any other form of standard education. This only makes us look worse.

    I’m wondering if a well-placed op-ed article in the Atlanta Journal-Constitution would help at all. To my knowledge there has been no coverage of this issue here within the state. A quick Google search reinforces my suspicions on that count. Of course the case has to play out in the courts, but a bit of political push might not hurt. If this case truly could undermine vaccine delivery in the US, then the public should have a chance to hear about the possibility.

  15. John Snyder says:

    SGNeill:

    Thanks for the info. I’m working on an Op-Ed now for the AJC.

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