Autism Omnibus Proceedings FAQs

By Mary Holland, Esq.

I will be posting summaries of the thimerosal-autism test cases starting May 12.  Below, I provide some answers and links that may be helpful in understanding this unusual proceeding.  My goal is to provide short, objective summaries of testimony every day for those people who do not have the time or inclination to listen to the hearings.  You may still sign up to get audio access to the hearings (HERE).

What is the Omnibus Autism Proceeding?

In 2002, the U.S. Court of Federal Claims’ decided Leroy v. Secretary of HHS and  started the unprecedented “Omnibus Autism Proceeding.”  Read more HERE 

Parents of autistic children had filed thousands of lawsuits around the country in ordinary state and federal courts, in addition to “vaccine court,” arguing that thimerosal, a mercury-containing preservative, caused their children’s autism.   Lawyers in ordinary courts argued that they should be able to proceed there, rather than in “vaccine court,” because thimerosal is a vaccine “adulterant” or “contaminant” under federal vaccine law. 

In Leroy, Chief Special Master Golkiewicz decided that because thimerosal is “vaccine-related,” its injuries should be heard first in “vaccine court” according to Congress’ National Childhood Vaccine Injury Compensation Act of 1986. Read more HERE.

Since 2002, petitioners have filed approximately 4,900 claims arguing that vaccines caused the petitioners’ autism.  The Court is holding hearings before Special Masters on three different theories:  (1) that the Mumps-Measles-Rubella vaccine together with thimerosal causes autism; (2) that thimerosal alone causes autism; and (3) that MMR alone causes autism.  Special Masters heard three “test cases” on the first MMR-thimerosal theory in June, 2007; the transcripts of those hearings are available at the Court’s website. (HERE)

The “test cases” starting May 12 are based on the theory that thimerosal alone causes autism.  (see April 23, 2008 Autism Update HERE)

What are the key provisions of the 1986 National Childhood Vaccine Injury Compensation Act?

Congress’ purpose in the 1986 National Childhood Vaccine Injury Compensation Act was to ensure vaccine safety and supply, reduce litigation against vaccine manufacturers, and to provide accessible compensation to those injured by vaccines.  This twenty-two year old law was a compromise: it provided vaccine manufacturers and health care providers with substantial immunity in exchange for what was meant to be secure and efficient compensation to victims. Read more HERE.  See also HERE.

What is “Vaccine Court”?

“Vaccine court” is the popular name for the hearings that occur in the U.S. Court of Federal Claims about injuries from vaccines.  Congress established this “no-fault” compensation system.

Who are the judges in vaccine court?  Is there a jury?

Congress created the office of Special Masters to be the judges of first instance in vaccine court.  There are no juries. 

The U.S. Court of Claims appoints lawyers as Special Masters for four-year terms to hear vaccine cases.  The petitioners or respondent, the U.S. Department of Health and Human Services, may appeal the Special Masters’ decisions to federal judges in the U.S. Court of Claims.  The Court of Claims has eight Special Masters.  In general, Special Masters manage vaccine cases and decide whether petitioners have established that vaccines caused injuries, and, if so, what damages the court should award.  Read more HERE.

The Omnibus Autism Proceeding is unprecedented in vaccine court.  Because of the volume of cases and the significance of the Proceeding, the Court decided to have three Special Masters hear the test cases under the autism-vaccine theories.  The three Special Masters hearing nine test cases on three theories of causation are Patricia Campbell-Smith, Denise Vowell and George L. Hastings, Jr.  There brief biographies are available on the Court’s website. (HERE.)

Who are the petitioners?

The petitioners are injured children and parents bringing claims on their behalf.  The parents had to file claims within three years of the start of injury symptoms.   

Who is the respondent?

The U.S. Department of Health and Human Services is the respondent; the U.S. Department of Justice acts as the lawyer for HHS.  Although HHS may settle cases without hearings, it is challenging the petitioners’ claims that thimerosal in vaccines caused petitioners’ autism.

What is the court’s burden of proof?  What do the petitioners have to prove?

The standard or burden of proof is a “preponderance of the evidence” or “more likely than not,” as in all civil lawsuits.  However, the U.S. Court of Appeals for the Federal Circuit – in other words, the highest authority except for the Supreme Court – has said that “close calls regarding causation are resolved in favor of injured claimants.”(Althen v. HHS, 418 F.3d 1274, 1280 (Fed. Cir. 2005))  The appellate court stated that a vaccine petitioner’s burden is:

“to show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” (Althen v. HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005))

The U.S. Court of the Appeals for the Federal Circuit reiterated this standard in Capizzano v. Health and Human Services, 440 F.3d 1317, 1324 (Fed. Cir. 2006) and acknowledged that vaccine injury is “a field bereft of complete and direct proof of how vaccines affect the human body.”  The Court repeated language from its 1994 Knudsen case that “to require identification and proof of specific biological mechanisms would be inconsistent with the purposes and nature of the vaccine compensation program.” Id.

What constitutes credible scientific evidence for the court?  How does the court evaluate scientific testimony and studies?

Special masters do not have to follow the Federal Rules of Evidence in vaccine hearings.  According to the Vaccine Rule 8 of the U.S. Court of Federal Claims, “the special master will consider all relevant and reliable evidence, governed by principles of fundamental fairness to both parties.” Read more HERE.  But what constitutes reliable scientific evidence is at the heart of this proceeding.  The Special Masters must assess the merit and credibility of many conflicting scientific studies and experts. 

The respondent asserts that petitioners must rely on “good science,” as outlined by the U.S. Supreme Court in its 1993 decision on how judges must instruct juries about scientific evidence (Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993)).  It argues that reliable science means tested hypotheses, laboratory results, testimony that withstands cross-examination and thorough studies. 

Petitioners agree that scientific evidence must be reliable, but they point to the Althen and Cappizano threshold of a plausible medical theory, a logical sequence of cause and effect and a proximate relationship between vaccine and injury. 

Both respondent and petitioners focus on the credibility of expert witnesses, focusing on their income from the pharmaceutical industry and expert testimony.

What kind of damages can petitioners get if the court finds that vaccines did cause their autism?

Vaccine court is not adjudicating damages now.  The court first decides if vaccines or vaccine-related components caused autism.  Only then, if the court finds causation, will it proceed to damages and hold separate hearings to decide amounts.  Under the NCVICA, some damages are capped, with a vaccine-related death receiving $250,000, pain and suffering receiving up to $250,000.  Petitioners may be awarded compensation for the medical needs of vaccine-injured children and reasonable attorneys’ fees.  There are no punitive damages available. (See 42 USC 300aa-15(a)(B)(2) HERE.)  The damage awards come from a federal vaccine compensation fund that results from a $.75 tax on all mandated vaccines.

If a petitioner brings suit in vaccine court but rejects the court’s decision, the petitioner may then bring a lawsuit in an ordinary court and may seek general and punitive damages against vaccine manufacturers.

Who are the lawyers?

Lawyers from around the country are bringing cases on behalf of vaccine-injured children against the Department of Health and Human Services.  The lawyers have formed a Petitioners’ Steering Committee to organize the cases and to select test cases.  The petitioners’ lawyers do not receive compensation until after the court reaches a judgment.  Then, the court may adjust the lawyers’ fees to what it deems reasonable.  The court advances no funds for petitioners’ legal services or for expert witnesses, so most petitioners’ lawyers have not received any payments for their services since this case began.

Respondent’s lawyers are full-time, salaried employees of the Department of Justice.  They work as a unified team and their compensation is not contingent on the conclusion of the proceedings.  Similarly, they have a robust budget to pay for expert witnesses.

Can petitioners or respondent appeal if they are dissatisfied by the court’s decision?  Who hears the appeal?

Both petitioners and respondent can appeal the decisions of Special Masters in vaccine court.  First, a dissatisfied party appeals to a single judge of the U.S. Court of Federal Claims who reviews the decision of the Special Master.  If either party is dissatisfied with that decision, it may appeal the decision to a three-judge panel of the Court of Appeals for the Federal Circuit.  This is almost always the court of last resort for vaccine cases.    

Can a petitioner opt out of “vaccine court” into another court?

Petitioners have the right to take their cases to federal or state civil court after having first filed their claims in this court.  It is likely that at least some petitioners will opt out to federal or state court after this court’s judgments because the opportunities for discovery and potential compensation are greater there.

What reputation does “vaccine court” have based on its history?

The court has a reputation of parsimony in award of damages; less than 25% of petitioners win.  By administratively reclassifying certain vaccine injuries in 1995 and 1997, HHS Secretary Shalala under the Clinton Administration made it harder for petitioners to receive compensation.  Critics of the system argue that it has failed to adequately compensate vaccine victims.  Read more HERE.

Do vaccine manufacturers and pharmaceutical companies have anything to do with this proceeding? 

Vaccine manufacturers are not respondents, but they have been formal participants in the proceeding.  The court required them to produce information about vaccines, and many pharmaceutical industry lawyers are following the proceedings closely. 

What’s the basic legal framework for mandatory vaccines?

The Supreme Court’s 1904 Jacobson v. Massachusetts decision created the basic framework.  It allowed states to compel their residents to accept vaccines unless it would be “cruel and unusual to the last degree” to do so.  (Jacobson v. Massachusetts, 197 U.S. 11 (1905))  It affirmed states’ rights under their police powers to put public health and welfare before an individual’s right to informed consent.

What happened during the hearings on the first test cases based on the theory that the Measles-Mumps-Rubella vaccine and thimerosal together combine to cause autism?

Starting in June 2007, Special Masters Patricia Campbell-Smith, Denise Vowell and George L. Hastings, Jr. heard three test cases on the theory that the MMR and thimerosal together cause autism.  The court has not yet decided these cases.  The full audio and written transcripts for those proceedings are available HERE

What did the Hannah Poling case have to do with the thimerosal test case that starts May 12?

One of the test cases that the Petitioners’ Steering Committee had selected for the thimerosal-autism theory was that of Hannah Pohling.  The Poling family and the Department of Health and Human Services agreed to take this case off the agenda when the government agreed to grant them compensation.  Although this settlement agreement was confidential, reporter David Kirby obtained a copy of the settlement and posted it on the internet HERE.  The Department of Justice lawyers agreed to compensate this case because “the vaccinations [Hannah Poling] received…significantly aggravated an underlying mitochondrial disorder…and manifested as a regressive encephalopathy with features of autism spectrum disorder.”

How do we expect petitioners’ lawyers to present, and respondent’s lawyer to rebut, the second test theory, that thimerosal alone causes autism?

Petitioners’ lawyers must present evidence and testimony that thimerosal causes neurodevelopmental harm, including autism.  They must show harmed the children in these specific cases. 

Respondents’ lawyers must challenge this evidence and testimony; they are likely to call it “junk science” and an unreliable basis for determining causation.  They are likely to attribute harm to factors other than thimerosal and to assert that it is impossible to infer causation from the available evidence.

What is the possible impact of these cases?

There’s no crystal ball, but it is likely that these proceedings will have a major impact on the public debate about the link between autism and mercury and the general safety of the U.S. vaccine program.

Mary Holland teaches at New York University Law School and may be contacted HERE.