On Oct. 12, the U.S. Supreme Court will hear Bruesewitz v. Wyeth, a case that threatens to flood the federal court system with about 5,000 largely meritless lawsuits that claim vaccines cause autism. There just isn't any decent evidence showing that vaccines cause autism. Yet because of the Supremes' ruling in a different, unrelated case (Wyeth v. Levine), there's a possibility that the court could plunge the judicial system down a science-free rabbit hole in which non-specialist civil judges will be forced to hear each and every one of these cases even though the law was specifically written to prevent that happening. The case is a Trojan horse for autism activists, but the Supremes may side with them anyway.
It's complicated, so here's the simple version:
In the 1980s, all but one manufacturer of the diphtheriaâ€"pertussisâ€"tetanus vaccine went out of business after a few autism* cases went against the companies, even though a series of large-scale studies show that vaccines -- even the ones containing the preservative thimerosal -- do not cause autism. With the U.S. vaccine supply in danger, and American children newly threatened by lethal diseases that had been wiped out decades earlier, a new law created a federal vaccine court so that patients claiming vaccine injuries could get quick, no-fault compensation at a rate that would allow drug companies to continue producing vaccines. That law, the National Childhood Vaccine Injury Act of 1986, states:
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 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.As a piece of written English, the law is horrible: It starts by suggesting that manufacturers will never be liable even if the injury was "associated" with the vaccine. Then there's a confusing bit suggesting some side effects are "unavoidable." And it ends with the notion that those "associated," "unavoidable" side effects occur even though the vaccine was "properly" made. Under this law, "properly" means passed and approved by the FDA. Thus, if the FDA allows a vaccine onto the market, vaccine claims are preempted -- not allowed into the federal court system. If you think you've been hurt by a vaccine, you have to go to vaccine court to prove your case.
Here's what happened after the law was passed, according to an amici brief by GlaxoSmithKline (GSK), Merck (MRK) and Sanofi-Aventis (ANY):
Allegations linking thimerosal to the onset of autism erupted in the early 2000s. Every government public health agency and reputable scientific body to address the question has rejected the hypothesis that thimerosal-containing pediatric vaccines ever caused or contributed to autism.
As of 2008, at least eight major studies had examined the effect of reductions or removal of thimerosal as a preservative from vaccines, and all demonstrated that autism rates failed to decline despite the removal of thimerosal.
Nonetheless, between 1999 and 2009, 5,600 claims relating to autism were filed in the Vaccine Court.Of those, 718 cases have concluded without compensation -- because there's no evidence that the vaccines cause autism -- and six test cases have all found that thimerosal does not cause autism. Nonetheless, 5,000 cases are still pending along with another 350 in various state civil courts.
The parents of Hannah Bruesewitz have come up with a clever argument as to why Wyeth's diphtheriaâ€"pertussisâ€"tetanus vaccine is to blame for her "autistic-like features." They argue that because the specific batch that Hannah received was linked to two deaths and more than 60 adverse events, that it counts as evidence the vaccine was improperly made and thus not "preempted" by the 1986 law.
If this were a normal drug tort case it would have been laughed out of court. Unfortunately, the Supremes ruled in Wyeth v. Levine -- a case about a migraine drug -- that not all claims against drug companies are "preempted" just because the FDA has allowed them onto the market. People have a right to sue, if a drug caused injury because it was defective anyway. Following that logic, the Supremes could decide that vaccine cases are not preempted if they claim that the vaccine was defectively manufactured. In fact, that's exactly what the autism activists are arguing in their amici brief.
You may still think it's unfair that parents of autistic children can't get their day in court. Even if the evidence is non-existent, and even if Congress already set up a system to deal with vaccine cases, surely they should still get a fair hearing? Bear in mind that under the current system, about 18 percent of all cases filed with the vaccine court do get some compensation. I know this because it's buried as a footnote on page 14 of the autism activists' own briefs.
*Change was made because autism was not claimed in these cases.
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- How Misinformation Gets the Jump on Facts in the Vaccine Wars
- Jim Carrey and Jenny McCarthy's "Historic" Study of Vaccines and Autism in Monkeys? Ah -- Never Mind.