Georgia on my mind


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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