The Cedillo Appeal – Mary Holland is a "Friend" to the Court and Autism Community

By Kent Heckenlively, Esq.

The autism community owes a great debt of thanks to attorney Mary Holland for putting together her excellent amici curiae (friend of the court) brief in the Cedillo appeal. Ms. Holland was surprised to find there had never been an amicus brief in a vaccine case before the Court of Appeals for the Federal Circuit and was delighted with the 23 autism organizations who supported the brief. She hopes that future issues concerning our community will generate a similar level of support.

A legal proceeding is a long process and sometimes it’s only in a brief such as the one that Holland put together that the outlines of what’s at stake, and what went wrong during the Omnibus Autism Proceeding become clear.

Michelle Cedillo was born healthy on August 30, 1994 and like other children at the time received twelve mandated vaccines containing ethyl mercury. At her fifteen month check-up she received a measles-mumps-rubella vaccine and seven days later developed a 105 degree fever. She also developed a rash. As the months went by Michelle’s pediatrician noticed she was less verbal and continued to have a rash. Around the time of her third birthday she was given a diagnosis of autism. Now fifteen years old, Michelle cannot talk, walk unassisted, or care for herself.

Holland’s excellent brief recounts the history of the National Vaccine Injury Compensation Act of 1986 which was designed to ensure the vaccine supply, improve vaccine safety, and generously compensate vaccine victims. Recovery was supposed to be based on certain criteria, such as a “temporal relationship between a vaccination and symptoms specified in a Vaccine Injury Table.” 

This point was made even more poignant by the fact that “Had the Cedillo family filed its claim three years earlier, in 1995, the Program presumptively would have compensated her for her encephalopathy, according to the Vaccine Injury Table. By administrative fiat, however, HHS removed this presumption from the Table in March 1995, forcing Michelle and others to prove causation. Although Judge Plager, in his dissent in Terran, eloquently explained how these changes violated the U. S. Constitution, he did not carry the day.”

As for the intention of the 1986 Act to advance the cause of vaccine safety the brief notes, “While 46 doses of nine new vaccines have been added to the Centers for Disease Control vaccine schedule, only one new symptom has been added to the table of injuries.”

Without doubt the single most important piece of physical evidence in the Cedillo cases was the finding by the Unigenetics Laboratory of Dr. John O’Leary of the vaccine-strain of the measles virus in a sample of intestinal tissue from Michelle Cedillo. Holland’s brief stated six reasons why this evidence should be deemed reliable.

  1. All parties agreed that Dr. John O’Leary is a highly respected, leading scientist in the field of polymerase chain reaction (PCR) testing.
  2. The government witnesses, Drs. Bustin and Rima, were experts in previous hearings in the United Kingdom on a potential MMR-autism link and had been highly paid for that testimony by vaccine manufacturers. Holland believed their strong affiliations with vaccine manufacturers should have been weighed against their claim of no link between vaccines and autism.
  3. Dr. Bustin’s testimony on the O’Leary lab was based on an inspection of lab notebooks which were not available to the Cedillo lawyers. (Note – In traditional civil trials it’s against the rules for all materials not to be available to both parties.)
  4. While Dr. Bustin was critical of procedures at the O’Leary laboratory, he only contested the accuracy of low levels of inflammatory markers. Michelle Cedillo had “high copy numbers” for inflammation.
  5. Two reputable independent labs, Dr. Finbar Cotter’s London laboratory and Dr. Michael Oldstone’s U. S. laboratory, replicated the O’Leary lab results. Replication by two additional labs is considered the standard for reliability in scientific testing.
  6. The O’Leary lab books that Dr. Bustin used for his testimony showed the O’Leary lab used both positive and negative controls. Dr. Bustin could only point to a single episode of contamination in the lab, while experts for both sides agreed that contamination occurs in every laboratory.

Holland also did an admirable job in bringing up the issue of the denial of access to the Vaccine Safety Datalink. “Although the Petitioners’ Steering Committee insisted that acces to the government’s best national vaccine safety data in the Vaccine Safety Datalink (VSD) was essential to the development of the test cases, Special Master Hastings never agreed to subpoena that critical, taxpayer-financed information to which HHS had access. Furthermore, the Petitioners’ Steering Committee sought to obtain documents from various manufacturers in discovery, showing that they had been concerned about mercury in vaccines long before Dr. Wakefield. Special Master Hastings denied such motions for discovery.”

There were additional issues brought up by Ms. Holland, such as a ten-fold mathematical error by government expert witness Dr. Rima in the Snyder case which caused him to declare the results for Michelle were “completely and utterly biologically implausible.”

All of these issues, though, are secondary to the central issue of Holland’s appeal, and to the frustration so many parents and medical professionals believe in regards to the entire vaccine compensation program.

The issue is whether the Vaccine Injury Compensation Program exists to compensate victims or to protect the integrity of the vaccine schedule. Holland believes no better example exists than when Special Master Hastings “abandoned his judicial role to opine that Michelle’s case was ‘one-sided,’ that her doctors were ‘very wrong,’ and that her doctors ‘are guilty . . . of gross medical misjudgment.’”

An address in March of 2008 by Chief Special Master Gary Golkiewicz explored the tension between these differing goals in greater detail:

“We all know from the legislative history, Congressman Waxman, a primary architect of the Program, stated at several Congressional hearings, the purpose of the program is to promote receipt and production of vaccines by protecting manufacturers and administrators from liability, but also to compensate those who suffer from a vaccine-related injury.”

“However, Congressman Waxman also articulated a competing policy concern. I call it protecting the vaccine’s integrity, and that is that vaccine does not cause every injury that follows immunization. There’s a tension between these two objectives, a tension that affects dramatically the litigation of the cases, the parties’ argument and ultimately who wins.”

In arguing that autism seems to be “legally taboo” to the Special Masters, Holland wrote: “The Special Master and the Court of Claims perhaps denied Michelle’s petition because one of her vaccine-induced injuries was called ‘autism.’ While special masters have compensated many cases in which the petitioners’ injuries included autism, these awards, in name, were for mental retardation, acute disseminating encephalomyelitis (ADEM) resulting in Pervasive Developmental Delay/Not Otherwise Specified (PDD/NOS) and autistic-like symptoms with an underlying mitochondrial disorder. To rule in Michelle’s favor is to reaffirm that vaccines are not harmless, and that they do sometimes cause adverse reactions.”

In concluding I want to give you the first paragraph of Ms. Holland’s argument in which she alludes to the twenty-three autism organizations who supported the brief, where we find ourselves today, and what she hopes will become the focus of research in the future. I believe it may be one of the best single pieces of writing about autism I’ve come across.

“As organizations, we represent or serve the one and a half million people in the United States who have an autism spectrum disorder. Autism is the fastest growing developmental disorder in this country and includes: (1) impairments in social interaction, (2) impairments in verbal and non-verbal communication, and (3) stereotypical restricted or repetitive patterns of behavior and interests. For decades, the autism prevalence was four to five per ten thousand children. In December 2009, the Centers for Disease Control announced that the rate among eight-year-olds is now 110 per ten thousand, or approximately one percent of all U. S. children. As Dr. Thomas Insel, Director of the National Institute of Mental Health and Chair of the Interagency Autism Coordinating Committee said in light of these new numbers, “There is no question that there has got to be an environmental component here.’”

For the sake of the children we already have and the children yet to be born, we need to find that component. I pray the courts do not stand in the way of that goal.

Kent Heckenlively is Legal Editor of Age of Autism