Michelle Cedillo v. Secretary of Health and Human Services, also known as Cedillo, was a court case involving the family of Michelle Cedillo, an autistic girl whose parents sued the United States government because they believed that her autism was caused by her receipt of both the measles-mumps-and-rubella vaccine (also known as the MMR vaccine) and thimerosal-containing vaccines. The case was a part of the Omnibus Autism Proceeding, where petitioners were required to present three test cases for each proposed mechanism by which vaccines had, according to them, caused their children's autism; Cedillo was the first such case for the MMR-and-thimerosal hypothesis.
The family sought compensation from the National Vaccine Injury Compensation Program (NVICP), but in order to qualify they were required to prove that it was more likely than not that their children's autism was caused by their vaccines. The scientific community had concluded that vaccines did not cause autism years before the first cases were heard, and concern was therefore expressed that the relatively lax evidentiary standards of the NVICP could lead to compensation being awarded in spite of the compelling scientific evidence to the contrary. This, some vaccine supporters argued, might have serious adverse public health effects by discouraging vaccine manufacturers from producing more childhood vaccines. Though the NVICP had existed since 1988, it was not designed to handle the thousands of cases it received from 1999 to 2007, which led to the establishment of the Omnibus Autism Proceeding in 2002.
The trial opened on June 11, 2007, in Washington, D.C. The Cedillos' six expert witnesses argued that thimerosal-containing vaccines degraded Michelle's immune system, which in turn made it possible for the weakened measles virus in the MMR vaccine to cause a persistent infection leading to autism. In support of this hypothesis, the Cedillos' witnesses relied on the reported detection of measles virus in Michelle's gastrointestinal tract by John O'Leary's Unigenetics laboratory in Dublin. However, the government's expert witnesses conclusively demonstrated that O'Leary's positive results were caused by contamination in the Unigenetics lab rather than an actual infection.
On February 12, 2009, the special masters ruled that the Cedillos were not entitled to compensation as they had failed to demonstrate that thimerosal-containing vaccines in combination with the MMR vaccine could cause autism. The special masters concluded, among other things, that the government's experts were considerably more qualified than those testifying on behalf of the families, with special master George Hastings stating that "the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment."
Background
The National Vaccine Injury Compensation Program was established in 1988 in the United States by the passing of the National Childhood Vaccine Injury Act, and is funded by a 75-cent tax on each vaccine dose. The program's aims were to maintain a steady supply of vaccines while, at the same time, allowing victims of vaccine injury to be compensated more efficiently than was previously possible. The program operates according to a no-fault principle. The family of Michelle Cedillo sought compensation from this program. Cedillo, a then 12-year-old female wheelchair user from Yuma, Arizona, was involved in the first of three test cases chosen by the government to represent the approximately 4,900 other vaccine-autism cases that had been brought before the court. Michelle Cedillo was born on August 30, 1994, and received thimerosal-containing vaccines during the first fifteen months of her life. On December 20, 1995, she received an MMR vaccine. Theresa and Michael Cedillo filed a vaccine injury claim on behalf of their daughter on December 9, 1998, for encephalopathy, but on January 14, 2002, changed their petition to a causation-in-fact claim, meaning they were arguing that Michelle developed autism as a result of the combined effects of thimerosal and the MMR vaccine. They did this as a result of a meeting that had taken place the previous year, between Theresa Cedillo and Andrew Wakefield, at a Defeat Autism Now! conference.
In 2001, many other families also filed suit in the NVICP, also because they believed their children's autism had been caused by vaccines and they were therefore entitled to compensation. The following year, the Office of Special Masters of the United States Court of Federal Claims held a series of meetings to decide how to deal with these claims, and that July, issued an order establishing the Omnibus Autism Proceeding. According to the Cedillos, Michelle was developmentally normal until she received her MMR vaccine at the age of 15 months, at which point she developed a 105-degree fever, began vomiting and developed diarrhea. Michelle was diagnosed with autism 18 months after receiving her MMR vaccine. According to The Washington Post, the legal standard to which the cases were subjected in this trial meant that "the outcome will hinge not on scientific standards of evidence but on a legal standard of plausibility—what one lawyer for the families called '50 percent and a feather'." It was in 2002 that, given the large number of litigants seeking compensation from the NVICP, the Omnibus Autism Proceeding was established. Its aim was to resolve pending vaccine-autism claims "aggressively but fairly."
Overview Prior to the Cedillo case beginning, the scientific community had conducted considerable research into the hypothesized link between either the MMR vaccine and autism or thimerosal-containing vaccines and autism. This research had consistently come to the conclusion that no such link existed. However, some vaccine supporters, such as Paul Offit, argued that the standards for proving a vaccine had "caused" an adverse effect in the NVICP were far too low, and that the court might therefore find in favor of the Cedillos anyway. They also argued that if this happened, the vaccine manufacturers might be discouraged from manufacturing childhood vaccines, which might lead to more frequent vaccine shortages.
In the Cedillo case, her family claimed that Michelle was normal until receiving her vaccines, as evidenced by a number of videos of her between the age of 6 and 8 months. They also argued that thimerosal-containing vaccines degraded her immune system, which made it possible for the measles virus to infect her and cause autism and the other health problems she has, which include inflammatory bowel disease, glaucoma and epilepsy. The evidence presented for this consisted primarily of the detection of measles virus in Michelle Cedillo's GI tract. According to the testimony of Marcel Kinsbourne, a pediatric neurologist and professor of psychology at the New School, the vaccine strain of measles virus caused autism by "... infect[ing] the gut and enter[ing] the brain, causing dysfunction of astrocytes and other brain cells, which in turn provokes high levels of the neurotransmitter glutamate, causing a state of overstimulation which manifests itself in the symptoms of autism."
Plaintiff's case The witnesses testifying on behalf of the state whose testimony attracted the most attention were Éric Fombonne, a psychiatrist at McGill University, Jeffrey Brent, a medical toxicologist at the University of Colorado Health Sciences Center, and Stephen Bustin of Queen Mary University of London. Other experts who testified on behalf of the state included Edwin Cook, a psychiatrist, Diane Griffin, a virologist at Johns Hopkins University, Stephen Hanauer, a gastroenterologist, Christine McCusker, a pediatric immunologist, Brian Ward, a virologist who, along with Fombonne, published some research which failed to replicate the Unigenetics lab's results, and Max Wiznitzer, a pediatric neurologist.
Those who testified on behalf of the plaintiffs were H. Vasken Aposhian, a toxicologist at the University of Arizona, Arthur Krigsman, a gastroenterologist at the Johnson Center for Child Health and Development, Karin Hepner, a molecular biologist at Wake Forest University, Vera Byers, a retired immunologist, Ronald C. Kennedy, a virus immunologist at Texas Tech University and Marcel Kinsbourne, a retired pediatric neurologist.
On June 11, 2007, the plaintiffs presented their first argument, in which they contended that Michelle Cedillo, as well as other children with autism, had a "mercury efflux disorder" which was described by Aposhian, their first expert witness, as "a problem with getting a metal, in this case mercury, out of a cell." As evidence that such disorders have been documented before, he pointed to Wilson's disease. Aposhian based this claim, in part, on three peer-reviewed papers. The first such study was co-authored by Boyd Haley, and concluded that hair of children with autism contained less mercury than that of children without autism. Aposhian stated that "we know that the hair is an excretory organ and that the hair is reflective of the mercury or the metal in the blood, and the blood is a reflection of the mercury in the tissues, and so the fact that the children with autism had less mercury in their hair was a hint or indication that perhaps there was mercury efflux disorder." The second of these studies was conducted by James B. Adams, and found that baby teeth of children with autism had more than twice as much mercury as those of children without autism. Aposhian cited this study as evidence that "autistic children have a greater body burden of mercury." Another study which Aposhian used to back up this statement was one conducted by Jeff Bradstreet and Mark Geier, which gave dimercaptosuccinic acid, a chelating agent, to children and concluded that children with autism excreted much more mercury thereafter than children without autism. Aposhian also cited a number of in vitro studies as evidence that thimerosal could cause immune system dysregulation.
The following day, the plaintiffs presented their second argument, namely that the measles vaccine had caused intestinal damage. Their witness that day was gastroenterologist Arthur Krigsman, who testified that his opinion in the case depended on whether measles virus had really been detected in the intestinal tissue of Michelle Cedillo and other children with autism by the Unigenetics lab, using a study conducted by him, Dr. Hepner, Steve Walker, and Jeff Segal as evidence that the Unigenetics lab's results were reliable. This study, however, was still in its preliminary stages at the time of the trial, and had only been presented as a poster at the International Meeting for Autism Research the year before, and Walker himself warned that "We haven't done anything to demonstrate that the measles virus is causing autism or even causing bowel disease."
On the trial's third day, the plaintiffs presented their next argument, which was that the Uhlmann paper, which had reported the presence of vaccine-strain measles virus in the GI tract of children with autism, used reliable PCR techniques to detect said virus. Their witness for that day was molecular biologist Karin Hepner, who testified that "... the positive and negative controls used by the Uhlmann authors [led by Dr. John J. O'Leary, who runs the Unigenetics lab in Dublin] were appropriate, that the operating procedure employed in the testing was appropriate to minimize the possibility of "contamination", and that the "assays" utilized were appropriately selected and implemented." She also contended that the two studies that had failed to replicate the Uhlmann paper's results were flawed for two reasons: because they looked at cells of children with autism rather than in their GI tract, and because they did not test children with autism with gastrointestinal dysfunction.