May 14, 2008 -- Contrary to media reports, a U.S. court has not yet issued any decisions on whether vaccines cause autism.
It's an important issue: About 5,000 cases remain in limbo -- at the parents' request -- as the so-called Omnibus Autism Proceeding grinds on.
This week, public hearings in the case resumed as parents of two 10-year-old boys asked the court to rule that thimerosal, a mercury-based vaccine preservative, triggered the boys' autism.
Media interest in the case has skyrocketed since one of the parents of Hannah Poling -- one of the families involved in the case -- last March announced that they'd won.
Indeed, in November 2007 the U.S. Department of Health and Human Services (HHS) conceded that vaccination could have aggravated Hannah's underlying mitochondrial disorder and caused her autism symptoms. The HHS Division of Vaccine Injury Compensation will compensate the Polings out of its $2.7 billion trust fund, built up from surcharges paid for every vaccination covered by the program.
So why is the court case still going on? What's at stake? Here are WebMD's answers to these and other frequently asked questions:
- Isn't the case over? Doesn't the concession in the Poling case mean the court already has ruled?
- Why does the federal government pay vaccine claims? Aren't vaccine companies responsible?
- What is the vaccine court?
- What does this have to do with autism?
- How do the Omnibus Autism Proceedings work?
- If the Special Masters rule that these people with autism likely suffered vaccine injury, does it mean that vaccines cause autism?
- When will there be rulings in the cases?
Isn't the case over? Doesn't the concession in the Poling case mean the court already has ruled?
No. "We reiterate that this court has issued no decision on the issue of vaccine causation of autism," the case's three "Special Masters" italicized in their March 27 update on the ongoing proceedings.
Exactly why the government decided to concede the Poling's case isn't clear. The Special Masters -- the federal judges hearing the cases -- say they "cannot provide any details concerning this matter" until the entire case is decided.
In documents leaked to the press, government lawyers wrote that the HHS Division of Vaccine Injury Compensation "has concluded that the vaccinations [Hannah Poling received] significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder."
Government health officials -- such as CDC Director Julie Gerberding, MD, MPH -- say the concession in the Poling case is not an official admission that vaccines can cause autism.
The Omnibus Autism Proceeding, which began in 2002, continues. This series of three hearings, each including three "test cases," will decide whether there's sufficient evidence that vaccines can cause autism.
The first hearings concluded in November 2007. However, attorneys for the claimants have asked for extra time to get new information from sealed U.K. court records, so no final rulings have been made. The second set of hearings began on May 12, and is scheduled to run through May 30, 2008. A third set of hearings is scheduled for mid-September 2008, although they may not be necessary (see below).
There has not yet been a decision in any of these cases.
Why does the federal government pay vaccine claims? Aren't vaccine companies responsible?
No medicine is 100% safe, and vaccines are no exception. Vaccines do vastly more good than harm, especially if nearly everyone is vaccinated. But if millions and millions of people are vaccinated, even a vaccine that harms just one person in a million will hurt a certain number of people.
Before 1988, Americans claiming vaccine injury simply sued the vaccine manufacturer. Successful suits in the 1970s and 1980s blamed vaccines for all kinds of unexplained illnesses, such as sudden infant death, intellectual disability, and epilepsy. This trend drove all but one maker of the childhood DPT vaccine out of the U.S. market.
To bring drugmakers back into the U.S. market, Congress in 1986 passed the Childhood Vaccine Injury Act, which protects vaccine makers against injury lawsuits. To compensate people for injuries from designated vaccines, the law created the Vaccine Injury Compensation Program (VICP). Funded by a surcharge on every dose of covered vaccines, as of May 2008 the VICP fund stands at over $2.7 billion.
Since 1988, there have been 8,313 claims filed, with 956 compensated to the tune of $859 million as of May 2008. Awards vary in size. The highest award paid so far was $9.1 million. Compensation pays for past and future medical expenses, rehabilitation, therapies, special education, equipment, placement, and lost earnings. It also provides up to $250,000 for pain and suffering.
What is the vaccine court?
"Vaccine court" is shorthand for the Office of Special Masters of the U.S. Court of Federal Claims. The Special Masters administer the system, established by law in October 1988, to oversee claims made to the Vaccine Injury Compensation Program.
The Vaccine Injury Compensation Program pays claims in two ways. The first, which is the intended mechanism for paying most claims, is a list of injuries and conditions called the Vaccine Injury Table. If these injuries and conditions begin within a defined period after vaccination, the vaccine is presumed to have caused them.
For these "on-Table" cases, people making claims do not have to prove that the vaccine actually caused the injury. However, the Secretary of Health and Human Services, the designated respondent in vaccine-injury claims, may defeat the claim by showing that the injury was most likely to have been caused by something not related to vaccination.
But there's a second way to make a claim. If a person claims injury from a vaccine on the list, but claims either a different medical condition from those listed or a different time frame, that person must establish that the vaccine most likely caused the condition.
These claims proceed much like regular lawsuits. And they result in an extra payment to people who win their cases: attorneys' fees and costs.
These trials are presided over by the Special Masters Office of the U.S. Court of Federal Claims -- the vaccine court.
What does this have to do with autism?
Autism is not specifically listed in the VICP's Vaccine Injury Table. That means that all claims that vaccines caused autism must be taken to the Special Masters. Each claimant must prove that vaccination was the likely cause of his or her autism.
As of May 2008, there had been 5,365 autism injury claims with 5,007 still awaiting a decision. Since each and every claim must prove the vaccine was the likely cause of autism, the sheer volume of the cases threatened to overwhelm the court.
So in 2002, the Special Master's office made a deal with lawyers on both sides. Instead of thousands of hearings to determine whether vaccination can be a cause of autism, there would be just three, with three test cases in each hearing.
These hearings are called the Omnibus Autism Proceedings.
How do the Omnibus Autism Proceedings work?
The Omnibus Autism Proceedings will be the final test for three somewhat different theories about how vaccines might cause autism:
- The first "theory of causation" is that measles-mumps-rubella (MMR) vaccines and vaccines containing thimerosal (a mercury-based preservative) can combine to cause autism.
- The second theory is that thimerosal-containing vaccines can cause autism.
- The third theory is that MMR vaccines, without regard to thimerosal, can cause autism.
Each hearing is comprised of three "test cases" for a total of nine cases (although that may soon change -- see below). Three different Special Masters officiate each case in a set, although all three Special Masters sit in to hear "theory of causation" arguments. Lawyers for the claimants have formed a Petitioners' Steering Committee, which has selected a small group of attorneys to try all of the cases.
The first set of three trials -- testing the theory that the MMR vaccine in combination with thimerosal-containing vaccines causes autism -- took place in June, October, and November 2007. You may not have heard much about them -- this was before the Hannah Poling concession spurred media interest.
But there's another reason you haven't heard much about them. By request of the claimants, the Special Masters have not yet ruled. The Petitioners' Steering Committee lawyers hope to obtain new evidence from sealed records in a U.K. court case in which parents claimed the MMR vaccine damaged their children (that litigation was discontinued by the judge in the British trial).
The next set of three trials, testing the theory that thimerosal in vaccines causes autism, began on May 12, 2008. The third test case was withdrawn at the last minute, but the Special Masters have instructed claimants' lawyers to come up with a replacement case by May 2, 2008. The hearings are scheduled to close on May 30.
The third set of trials, testing the theory that the MMR vaccine causes autism, is scheduled for mid-September 2008. However, there is some question as to whether these trials will proceed. Lawyers for the claimants have said they would rely on evidence already presented in the first series of trials, and that they will identify only one test case.
In an April 16, 2008, order, the Special Masters said they would favor the offer by the Petitioners' Steering Committee to have this single case heard by a single Special Master, relying on the causation evidence from the first group of cases. Justice department lawyers representing HHS have agreed to this, so it's likely this will become a single case -- like any other before the vaccine court -- and not a test case.
If the Special Masters rule that these people with autism likely suffered vaccine injury, does it mean that vaccines cause autism?
No. The Office of Special Masters makes legal rulings, not scientific rulings. The Special Masters are trying to interpret the law as intended by Congress, not the laws of nature.
In a precedent-setting 2006 ruling in a case involving hepatitis B vaccine, Special Master Laura D. Millman noted that "The Vaccine Act established a federal 'compensation program' under which awards are to be 'made to vaccine-injured persons quickly, easily, and with certainty and generosity.' … The Court of Federal Claims is therefore not to be seen as a vehicle for ascertaining precisely how and why DPT and other vaccines sometimes destroy the health and lives of certain children while safely immunizing most others."
All that a Special Master needs to offer compensation, Millman suggested, is "a medical explanation of a logical sequence of cause and effect" and "medical probability rather than certainty" linking vaccination to injury. Millman spells out what she means by medical probability -- a theory that has "biologic credibility or plausibility rather than exact biologic mechanism."
Millman is not one of the Special Masters assigned to the Omnibus Autism Proceedings. It remains to be seen whether arguments that vaccines can cause autism will convince any of the three Special Masters to make awards in the case.
Most scientists remain highly skeptical of the vaccine/autism link. Even proponents of the link now tend to argue that vaccines cause autism only in children with some hidden, underlying susceptibility to vaccination.
Some scientists say that if the vaccine court awards compensation to people claiming that vaccines trigger autism, the public will lose faith in vaccination. Those in favor of such compensation say people are more likely to accept vaccination when they know the true risks.
When will there be rulings in the cases?
The Special Masters have indicated that they are ready to make a ruling on the first three test cases, and on the first theory of causation -- that the MMR vaccine in combination with thimerosal-containing vaccines can cause autism. However, they're waiting for the claimants' lawyers to obtain, or give up on, sealed evidence they are trying to get from a British court.
It's possible a ruling on the second theory could come soon after the hearings end in May 2008.
But don't bet on an early resolution of this matter. In 2002, when the Omnibus Autism Proceedings began, the single Special Master then assigned to the cases apologized to the claimants that the hearings would take a long time -- and warned there might not be a decision until July 3, 2004.