The Autism Cases

In last month's issue, we discussed the Vaccine Court's (Office of Special Masters of the U.S. Court of Federal Claims) trio of decisions that found no causative links between childhood vaccinations and the onset of autism and gastrointestinal problems in three children. In all three cases, the claimants sought compensation from the National Vaccine Injury Compensation Program (Vaccine Program) (See 42 U.S.C. ' 300aa-10, et. seq.), which, since 1988, has compensated victims of known or proven vaccination side effects.

We focused on the case of Michelle Cedillo, a child who was reaching all of her developmental milestones until shortly after she received an MMR (measles, mumps, rubella) shot in December 1995. In the week following the inoculation, she developed a high fever and gastrointestinal complaints. She soon lost the ability to do many of the things she had once done, including her speech capabilities. Michelle was diagnosed with autism in July 1997.

Michelle's parents filed a claim seeking compensation from the Vaccine Program, asserting that: 1) Michelle contracted autism through exposure to thimerosal; 2) Michelle contracted autism through exposure to the measles virus in the MMR vaccine; and 3) Michelle developed gastrointestinal dysfunction due to exposure to the measles virus in the MMR vaccine. The decision on these claims, issued by Special Master George L. Hastings Jr. in Cedillo v. Sec'y of HHS, No. 98-916V (Spec. Mstr. Feb. 12, 2009), said that the Cedillos had failed to prove that the vaccines caused Michelle's autism and/or her gastrointestinal ailments.

On March 16, Michelle and her parents filed a 77-page motion for review of the Feb. 12 decision. (Available at: http://www.rescuepost.com/files/michellesappeal03162009.pdf) They cited several reasons why the dismissal of their case should be overturned, among them, an inordinately high standard of proof and an unwavering reliance on the opinions of the government's witnesses, indicating to the movants that the fact finder had abandoned his duty to remain impartial.

The Burden of Proof

In several places in the dismissal decision, Special Master Hastings notes that evidence offered by the Cedillos would not meet the Daubert standard. (The standard, derived from Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S. 579 (1993), permits exclusion of evidence if the theory espoused is not scientifically reliable.) The movants pointed to these statements as evidence that the Special Master held their evidence to too high a standard, discounting their proffer of circumstantial evidence as inadequate “proof” that Michelle suffered autism and Irritable Bowel Syndrome (IBS) because of MMR shots. This, they said, was contrary to Congressional intent at the time it instituted the Vaccine Program.

The Vaccine Program was created because the members of Congress understood that: 1) universal vaccination against certain common diseases was beneficial for society as a whole; and 2) private actions against vaccine producers were unsatisfactory, both for victims of vaccine injuries and manufacturers, because of the costs and the time needed to bring a claim to conclusion. To promote the development of new and useful vaccines, and also to help the families of those injured by them, Congress set up the Vaccine Program in a manner intended to protect manufacturers from lawsuits while also compensating victims, even if those victims could not definitively prove a causal relationship between a vaccine and an illness or disability.

The Cedillos pointed to the legislative history of section 13 of the Act that implemented the Vaccine Program. It discusses the inevitable over-inclusion that follows from lowering the standard of proof for the so-called non-table injuries. (If an injury is listed in the Vaccine Table, it is because it is a well-known side-effect of a particular vaccine. With a table injury, compensation will be paid even absent proof that the vaccine caused the injury, as long as it surfaces during the period of time following vaccination in which such injuries generally appear.) Included in that history is the following passage: “The Committee recognizes that there is public debate over the incidence of illnesses that coincidentally occur within a short time of vaccination. The committee further recognizes that the deeming of vaccine-relatedness adopted here may provide compensation to some children whose illness is not, in fact, vaccine-related.” H.R. Rep. No. 99-908, 99th Cong., 2d. Session, Page 18 (1986). The Cedillos asserted that this passage indicated Congress' acceptance that there would be some uncertainty as to causation in non-table vaccine injury claims, but that that should not preclude payment.

In order to prove that the MMR vaccine caused Michelle's autism, the Cedillos were required, according to the leading case of Althen v. Secretary of HHS, 418 F.3d 1274 (Fed. Cir. 2005), to: “1) Put forward a medical theory causally connecting the vaccination and the injury; 2) Demonstrate a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and 3) Prove [] a proximate temporal relationship between vaccination and injury.” These forms of circumstantial evidence were provided to the Special Master, the Cedillos said, as summarized in their motion brief:

Has Michelle satisfied the Althen factors? Clearly, she has a medical theory. Her evidence is overwhelming that the MMR vaccine is capable of causing a wide variety of brain injuries, including autism. Next, there was a logical sequence of cause and effect between her MMR vaccine and her injury. She was healthy, received an MMR vaccine, and as her several treating physicians attest, she was never again the same. There is no question that her symptoms first occurred within an appropriate time after her MMR vaccine. This fact is supported by Michelle's medical records ' . It is even supported by the Vaccine Injury Table that lists “5-15″ days after the MMR vaccine as the appropriate time frame for the onset of symptoms of brain damage.

The movants also cited to Federal Circuit Court decisions in which those courts interpreted the burden of proof under the Vaccine Act as requiring less than the scientifically provable causation evidence ' meeting the Daubert standards for admissibility ' normally required in order to prove a right to recover damages in a tort action. For example, in Capizzano v. Sec'y of HHS, 440 F.3d 1317 (Fed. Cir. 2006), the U.S. Court of Appeals for the Federal Circuit reversed the dismissal of a claim seeking compensation for vaccine-related injuries. The court found that the special master had impermissibly raised the standard of proof for recovery under the Vaccine Act by requiring proof of causation in the forms of epidemiological studies, the presence of pathological markers or genetic disposition, or general acceptance in the scientific or medical communities. This, the court found, was contrary to its previous pronouncement of the standard of proof, articulated in Althen, which allows a claimant to prove his or her case with the use of circumstantial evidence. The Court of Appeals perceived Congress had envisioned the use of circumstantial evidence when it applied the preponderance standard to the issue of causation in vaccine cases. Quoting Althen, the Court of Appeals concluded that the special master's treatment of the Capizzano claims impermissibly raised their burden under the Vaccine Act and hindered “the system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants.”

The Burden of Persuasion

Once they had offered their prima facie proof in accordance with Althen, the Cedillos argued, the burden of refuting causation should have shifted to the government. Citing to the teachings of Knudsen by Knudsen v. Sec'y of Dept. of Health and Human Services, 35 F.3d 543 (1994), they said the government, in order to prevail, should have been required not only to submit proof of alternative causes for Michelle's autism and IBS, but they should also have had to prove that those alternative causes were the predominant reasons that Michelle developed her maladies. To meet this burden, the government submitted that there is only one cause of autism: genetics. In response, the Cedillos' motion papers state:

In this regard, Michelle submits, genetic susceptibility plays a role in all vaccine injuries. Frequently, non-vaccine environmental factors also contribute to the injury. However, when concurrent forces cause a single harm, the Federal Circuit has held, the burden in on the government to show that the alternative cause is so predominant that the vaccines insignificant. See Shyface [v. Secretary of HHS], 165 F.3d [1352 (Fed.Cir. 1999)] at 1352. Therefore, the Court has stated, if evidence established equally plausible etiologies for an injury then the petitioner should prevail. See Knudsen, 35 F.3d at 550. In such cases, the government must eliminate the vaccine as a substantial contributing factor. See Shyface, 165 F.3d at 1353.

As the Federal Circuit noted in Walther v. Secretary of Health and Human Services, 485 F.3d 1146 (Fed.Cir. 2007), “the petitioner generally has the burden on causation, but when there are multiple independent potential causes, the government has the burden to prove that the covered vaccine did not cause the harm.” Therefore, according to the Cedillos, it was not their burden to eliminate all other potential causes of Michelle's autism from the picture; it was the government's burden. This, they claim, the government failed to do. However, the motion papers state, using “Daubert as a clout,” Special Master Hastings rejected the Cedillos' prima facie evidence of causation, thereby relieving the government of its burden of proving that the MMR vaccine did not significantly contribute to Michelle's development of autism.

Dueling Experts

The Cedillos were unhappy with the fact that the Special Master gave credence to the 17 experts called by the federal government, even though their opinions were sought years after Michelle's autism developed, and even though none of them had ever personally examined her. Conversely, little weight was given to the opinions of the doctors who treated Michelle, noted the development of her symptoms soon after she received her first MMR shot, witnessed the deterioration of her condition and testified about it. In the words of the motion, the Special Master “rejected all of Michelle's credible evidence and blindly accepted the conclusions of the respondent's seventeen experts.” (Emphasis in original.)

The Special Master determined, for example, that Michelle did not, in fact, have inflammatory bowel disease, despite the diagnosis of such by her current treating gastroenterologist. In addition, Dr. Arthur Krigsman, a pediatric gastroenterologist, testified concerning tests he had done on Michelle, and on thousands of other autistic children. He diagnosed Michelle with IBS. In making his diagnosis, Dr. Krigsman examined Michelle and reviewed her medical history, which included evidence of a serological marker for irritable bowel disease, as well as evidence of pre-Crohn's disease symptoms. Michelle had documented diagnoses of uveitis (inflammation of the eye) and arthritis, which are often associated with irritable bowel disease. The Special Master was dismissive of Dr. Krigsman's testimony, noting that part of his incredulity rested on the fact that Dr. Krigsman had been the target of two disciplinary actions, one instituted in Texas and the other in Florida. The motion for rehearing points out, however, that the Texas matter was resolved in Dr. Krigsman's favor, and the hospital paid him damages. The Florida matter concerned nothing more than a failure to fulfill a continuing education requirement imposed by that state's medical board.

The Cedillos claimed the Special Master ignored all of this as well as other proffered evidence of Michelle's digestive disease and relied solely on the government experts' ultimate conclusions. In doing so, he allegedly completely ignored the government's experts' concessions to the Cedillos' positions. By way of example, Dr. Stephen Hanauer testified that he did not believe that Michelle had IBS, although he was not a pediatric gastroenterologist, had never examined Michelle for irritable bowel disease and, in fact, had never examined any autistic child in this regard. Dr. Hanauer admitted during testimony that Michelle apparently suffers from significant bowel problems. He conceded, according to the motion papers, that she had “apthous ulcers, which can evolve into IBD, specifically Crohn's disease, and that the ulcers are often the first sign of Crohn's disease.” And while Dr. Hanauer denied during testimony that IBD could be caused by a virus, his own writings indicated a different belief. A 2006 article authored by Dr. Hanauer and others said that there was a growing body of data indicating that a dysfunctional immune response could be implicated in the development of IBD. The immune response in question could be caused by a virus, the article went on to state. When questioned about this article on cross-examination, Dr. Hanauer admitted that the possibility of a virus precipitating a chronic inflammatory response was “the hypothesis we are currently working on.” Despite these and other concessions to the Cedillos' contention that Michelle suffers from IBS and that she got it from the measles virus contained in her MMR shot, the Special Master accepted as true Dr. Hanauer's assertion that Michelle does not have IBS.

Saving the Vaccination Program at Michelle's Expense

The Cedillos offered a list of other cases in which claimants were awarded compensation through the Vaccine Program even though their evidence, like the Cedillos', was circumstantial and would not have survived a Daubert motion for exclusion. The list of adverse events for which these claimants were compensated ranged from scarring following inoculation to death. Vaccinations of several types were represented in this list.

The movants went on to note that in each of the cited cases, the respondent federal government had argued, as it had in the Cedillo case, that there was no scientific evidence that the vaccines in question caused the complained of deaths or maladies. True though these government assertions were, those claimants were awarded compensation after they showed that they were healthy before their vaccines; that they developed symptoms after they were vaccinated that were contemporaneous with the vaccination; that their medical caregivers suspected that the vaccine was the cause of their ailments; and no other explanation for their medical problems could be found.

The movants asserted that the reason Michelle's case came out differently than these others ' despite the similarities between her evidence and the successful claimants' evidence ' was that this was a test case for a multitude of autism/vaccine cases. Her case, which had garnered massive publicity, was being watched by parents, medical practitioners, pharmaceutical manufacturers and government agencies. Its outcome could affect whether children would be inoculated, and it could affect decisions over the development of new drugs. In other words, allowing Michelle's or similar cases to proceed to award could harm vaccination programs, which undeniably benefit society as a whole. The Cedillos concluded that the Special Master took these concerns into account, and thereafter abandoned his role as an impartial judge of the evidence. Instead, according to the Cedillos' motion, he took on the role of the respondent federal government, and “[Michelle] was sacrificed to protect the integrity of vaccines.”

Conclusion

The Cedillos await a response to their motion for rehearing. If denied, they will likely appeal to the U.S. Court of Appeals for the D.C. Circuit, although winning such an appeal will be an uphill battle. “It's fairly difficult to have a special master's decision reversed,” says Sarah Wilson, special counsel at Covington & Burling and a former Court of Federal Claims judge. “It's definitely a deferential standard of review.”

And, like other claimants who've been denied compensation through the Vaccine Program (or whose cases before the Vaccine Court have been pending for more than a year), the Cedillos can opt to bring tort claims in state courts. Of course, the likelihood of success in such cases is minimal, considering the higher burden of proof imposed outside of the Vaccine Program.

Janice G. Inman is Editor-in-Chief of this newsletter.

In last month's issue, we discussed the Vaccine Court's (Office of Special Masters of the U.S. Court of Federal Claims) trio of decisions that found no causative links between childhood vaccinations and the onset of autism and gastrointestinal problems in three children. In all three cases, the claimants sought compensation from the National Vaccine Injury Compensation Program (Vaccine Program) (See 42 U.S.C. ' 300aa-10, et. seq.), which, since 1988, has compensated victims of known or proven vaccination side effects.

We focused on the case of Michelle Cedillo, a child who was reaching all of her developmental milestones until shortly after she received an MMR (measles, mumps, rubella) shot in December 1995. In the week following the inoculation, she developed a high fever and gastrointestinal complaints. She soon lost the ability to do many of the things she had once done, including her speech capabilities. Michelle was diagnosed with autism in July 1997.

Michelle's parents filed a claim seeking compensation from the Vaccine Program, asserting that: 1) Michelle contracted autism through exposure to thimerosal; 2) Michelle contracted autism through exposure to the measles virus in the MMR vaccine; and 3) Michelle developed gastrointestinal dysfunction due to exposure to the measles virus in the MMR vaccine. The decision on these claims, issued by Special Master George L. Hastings Jr. in Cedillo v. Sec'y of HHS, No. 98-916V (Spec. Mstr. Feb. 12, 2009), said that the Cedillos had failed to prove that the vaccines caused Michelle's autism and/or her gastrointestinal ailments.

On March 16, Michelle and her parents filed a 77-page motion for review of the Feb. 12 decision. (Available at: http://www.rescuepost.com/files/michellesappeal03162009.pdf) They cited several reasons why the dismissal of their case should be overturned, among them, an inordinately high standard of proof and an unwavering reliance on the opinions of the government's witnesses, indicating to the movants that the fact finder had abandoned his duty to remain impartial.

The Burden of Proof

In several places in the dismissal decision, Special Master Hastings notes that evidence offered by the Cedillos would not meet the Daubert standard. (The standard, derived from Daubert v. Merrell Dow Pharmaceuticals Inc. , 509 U.S. 579 (1993), permits exclusion of evidence if the theory espoused is not scientifically reliable.) The movants pointed to these statements as evidence that the Special Master held their evidence to too high a standard, discounting their proffer of circumstantial evidence as inadequate “proof” that Michelle suffered autism and Irritable Bowel Syndrome (IBS) because of MMR shots. This, they said, was contrary to Congressional intent at the time it instituted the Vaccine Program.

The Vaccine Program was created because the members of Congress understood that: 1) universal vaccination against certain common diseases was beneficial for society as a whole; and 2) private actions against vaccine producers were unsatisfactory, both for victims of vaccine injuries and manufacturers, because of the costs and the time needed to bring a claim to conclusion. To promote the development of new and useful vaccines, and also to help the families of those injured by them, Congress set up the Vaccine Program in a manner intended to protect manufacturers from lawsuits while also compensating victims, even if those victims could not definitively prove a causal relationship between a vaccine and an illness or disability.

The Cedillos pointed to the legislative history of section 13 of the Act that implemented the Vaccine Program. It discusses the inevitable over-inclusion that follows from lowering the standard of proof for the so-called non-table injuries. (If an injury is listed in the Vaccine Table, it is because it is a well-known side-effect of a particular vaccine. With a table injury, compensation will be paid even absent proof that the vaccine caused the injury, as long as it surfaces during the period of time following vaccination in which such injuries generally appear.) Included in that history is the following passage: “The Committee recognizes that there is public debate over the incidence of illnesses that coincidentally occur within a short time of vaccination. The committee further recognizes that the deeming of vaccine-relatedness adopted here may provide compensation to some children whose illness is not, in fact, vaccine-related.” H.R. Rep. No. 99-908, 99th Cong., 2d. Session, Page 18 (1986). The Cedillos asserted that this passage indicated Congress' acceptance that there would be some uncertainty as to causation in non-table vaccine injury claims, but that that should not preclude payment.

In order to prove that the MMR vaccine caused Michelle's autism, the Cedillos were required, according to the leading case of Althen v. Secretary of HHS , 418 F.3d 1274 (Fed. Cir. 2005), to: “1) Put forward a medical theory causally connecting the vaccination and the injury; 2) Demonstrate a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and 3) Prove [] a proximate temporal relationship between vaccination and injury.” These forms of circumstantial evidence were provided to the Special Master, the Cedillos said, as summarized in their motion brief:

Has Michelle satisfied the Althen factors? Clearly, she has a medical theory. Her evidence is overwhelming that the MMR vaccine is capable of causing a wide variety of brain injuries, including autism. Next, there was a logical sequence of cause and effect between her MMR vaccine and her injury. She was healthy, received an MMR vaccine, and as her several treating physicians attest, she was never again the same. There is no question that her symptoms first occurred within an appropriate time after her MMR vaccine. This fact is supported by Michelle's medical records ' . It is even supported by the Vaccine Injury Table that lists “5-15″ days after the MMR vaccine as the appropriate time frame for the onset of symptoms of brain damage.

The movants also cited to Federal Circuit Court decisions in which those courts interpreted the burden of proof under the Vaccine Act as requiring less than the scientifically provable causation evidence ' meeting the Daubert standards for admissibility ' normally required in order to prove a right to recover damages in a tort action. For example, in Capizzano v. Sec'y of HHS , 440 F.3d 1317 (Fed. Cir. 2006), the U.S. Court of Appeals for the Federal Circuit reversed the dismissal of a claim seeking compensation for vaccine-related injuries. The court found that the special master had impermissibly raised the standard of proof for recovery under the Vaccine Act by requiring proof of causation in the forms of epidemiological studies, the presence of pathological markers or genetic disposition, or general acceptance in the scientific or medical communities. This, the court found, was contrary to its previous pronouncement of the standard of proof, articulated in Althen, which allows a claimant to prove his or her case with the use of circumstantial evidence. The Court of Appeals perceived Congress had envisioned the use of circumstantial evidence when it applied the preponderance standard to the issue of causation in vaccine cases. Quoting Althen, the Court of Appeals concluded that the special master's treatment of the Capizzano claims impermissibly raised their burden under the Vaccine Act and hindered “the system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants.”

The Burden of Persuasion

Once they had offered their prima facie proof in accordance with Althen, the Cedillos argued, the burden of refuting causation should have shifted to the government. Citing to the teachings of Knudsen by Knudsen v. Sec'y of Dept. of Health and Human Services , 35 F.3d 543 (1994), they said the government, in order to prevail, should have been required not only to submit proof of alternative causes for Michelle's autism and IBS, but they should also have had to prove that those alternative causes were the predominant reasons that Michelle developed her maladies. To meet this burden, the government submitted that there is only one cause of autism: genetics. In response, the Cedillos' motion papers state:

In this regard, Michelle submits, genetic susceptibility plays a role in all vaccine injuries. Frequently, non-vaccine environmental factors also contribute to the injury. However, when concurrent forces cause a single harm, the Federal Circuit has held, the burden in on the government to show that the alternative cause is so predominant that the vaccines insignificant. See Shyface [v. Secretary of HHS], 165 F.3d [1352 (Fed.Cir. 1999)] at 1352. Therefore, the Court has stated, if evidence established equally plausible etiologies for an injury then the petitioner should prevail. See Knudsen, 35 F.3d at 550. In such cases, the government must eliminate the vaccine as a substantial contributing factor. See Shyface, 165 F.3d at 1353.

As the Federal Circuit noted in Walther v. Secretary of Health and Human Services , 485 F.3d 1146 (Fed.Cir. 2007), “the petitioner generally has the burden on causation, but when there are multiple independent potential causes, the government has the burden to prove that the covered vaccine did not cause the harm.” Therefore, according to the Cedillos, it was not their burden to eliminate all other potential causes of Michelle's autism from the picture; it was the government's burden. This, they claim, the government failed to do. However, the motion papers state, using “Daubert as a clout,” Special Master Hastings rejected the Cedillos' prima facie evidence of causation, thereby relieving the government of its burden of proving that the MMR vaccine did not significantly contribute to Michelle's development of autism.

Dueling Experts

The Cedillos were unhappy with the fact that the Special Master gave credence to the 17 experts called by the federal government, even though their opinions were sought years after Michelle's autism developed, and even though none of them had ever personally examined her. Conversely, little weight was given to the opinions of the doctors who treated Michelle, noted the development of her symptoms soon after she received her first MMR shot, witnessed the deterioration of her condition and testified about it. In the words of the motion, the Special Master “rejected all of Michelle's credible evidence and blindly accepted the conclusions of the respondent's seventeen experts.” (Emphasis in original.)

The Special Master determined, for example, that Michelle did not, in fact, have inflammatory bowel disease, despite the diagnosis of such by her current treating gastroenterologist. In addition, Dr. Arthur Krigsman, a pediatric gastroenterologist, testified concerning tests he had done on Michelle, and on thousands of other autistic children. He diagnosed Michelle with IBS. In making his diagnosis, Dr. Krigsman examined Michelle and reviewed her medical history, which included evidence of a serological marker for irritable bowel disease, as well as evidence of pre-Crohn's disease symptoms. Michelle had documented diagnoses of uveitis (inflammation of the eye) and arthritis, which are often associated with irritable bowel disease. The Special Master was dismissive of Dr. Krigsman's testimony, noting that part of his incredulity rested on the fact that Dr. Krigsman had been the target of two disciplinary actions, one instituted in Texas and the other in Florida. The motion for rehearing points out, however, that the Texas matter was resolved in Dr. Krigsman's favor, and the hospital paid him damages. The Florida matter concerned nothing more than a failure to fulfill a continuing education requirement imposed by that state's medical board.

The Cedillos claimed the Special Master ignored all of this as well as other proffered evidence of Michelle's digestive disease and relied solely on the government experts' ultimate conclusions. In doing so, he allegedly completely ignored the government's experts' concessions to the Cedillos' positions. By way of example, Dr. Stephen Hanauer testified that he did not believe that Michelle had IBS, although he was not a pediatric gastroenterologist, had never examined Michelle for irritable bowel disease and, in fact, had never examined any autistic child in this regard. Dr. Hanauer admitted during testimony that Michelle apparently suffers from significant bowel problems. He conceded, according to the motion papers, that she had “apthous ulcers, which can evolve into IBD, specifically Crohn's disease, and that the ulcers are often the first sign of Crohn's disease.” And while Dr. Hanauer denied during testimony that IBD could be caused by a virus, his own writings indicated a different belief. A 2006 article authored by Dr. Hanauer and others said that there was a growing body of data indicating that a dysfunctional immune response could be implicated in the development of IBD. The immune response in question could be caused by a virus, the article went on to state. When questioned about this article on cross-examination, Dr. Hanauer admitted that the possibility of a virus precipitating a chronic inflammatory response was “the hypothesis we are currently working on.” Despite these and other concessions to the Cedillos' contention that Michelle suffers from IBS and that she got it from the measles virus contained in her MMR shot, the Special Master accepted as true Dr. Hanauer's assertion that Michelle does not have IBS.

Saving the Vaccination Program at Michelle's Expense

The Cedillos offered a list of other cases in which claimants were awarded compensation through the Vaccine Program even though their evidence, like the Cedillos', was circumstantial and would not have survived a Daubert motion for exclusion. The list of adverse events for which these claimants were compensated ranged from scarring following inoculation to death. Vaccinations of several types were represented in this list.

The movants went on to note that in each of the cited cases, the respondent federal government had argued, as it had in the Cedillo case, that there was no scientific evidence that the vaccines in question caused the complained of deaths or maladies. True though these government assertions were, those claimants were awarded compensation after they showed that they were healthy before their vaccines; that they developed symptoms after they were vaccinated that were contemporaneous with the vaccination; that their medical caregivers suspected that the vaccine was the cause of their ailments; and no other explanation for their medical problems could be found.

The movants asserted that the reason Michelle's case came out differently than these others ' despite the similarities between her evidence and the successful claimants' evidence ' was that this was a test case for a multitude of autism/vaccine cases. Her case, which had garnered massive publicity, was being watched by parents, medical practitioners, pharmaceutical manufacturers and government agencies. Its outcome could affect whether children would be inoculated, and it could affect decisions over the development of new drugs. In other words, allowing Michelle's or similar cases to proceed to award could harm vaccination programs, which undeniably benefit society as a whole. The Cedillos concluded that the Special Master took these concerns into account, and thereafter abandoned his role as an impartial judge of the evidence. Instead, according to the Cedillos' motion, he took on the role of the respondent federal government, and “[Michelle] was sacrificed to protect the integrity of vaccines.”

Conclusion

The Cedillos await a response to their motion for rehearing. If denied, they will likely appeal to the U.S. Court of Appeals for the D.C. Circuit, although winning such an appeal will be an uphill battle. “It's fairly difficult to have a special master's decision reversed,” says Sarah Wilson, special counsel at Covington & Burling and a former Court of Federal Claims judge. “It's definitely a deferential standard of review.”

And, like other claimants who've been denied compensation through the Vaccine Program (or whose cases before the Vaccine Court have been pending for more than a year), the Cedillos can opt to bring tort claims in state courts. Of course, the likelihood of success in such cases is minimal, considering the higher burden of proof imposed outside of the Vaccine Program.

Janice G. Inman is Editor-in-Chief of this newsletter.