What Went Wrong?

A recent U.S. Court of Appeals for the Federal Circuit decision reversing the U.S. Court of Federal Claims' denial of a vaccine injury claim highlights the widening gulf between the Federal Circuit and Federal Claims court on vaccine cases. On June 18, the Federal Circuit reversed the Federal Claims court's decision to deny the petitioner compensation under the National Vaccine Injury Compensation Program. Andreu v. Secretary of Health and Human Services, — F.3d —-, 2009 WL 1688231 (C.A.Fed. 6/18/09).

The Case

The vaccine compensation program is a no-fault system for injury claims from a variety of vaccines. The U.S. Department of Health and Human Services administers the program with the U.S. Department of Justice and the U.S. Court of Federal Claims in Washington. Special masters hear cases filed at the Federal Claims Court, but either side can appeal rulings to the court and ultimately to the Federal Circuit.

The Andreu case, brought on behalf of Enrique Andreu, alleged that he began having seizures in late 1995, the day after receiving a diphtheria, whole-cell pertussis and tetanus (DPT) vaccine at the age of eight weeks. The seizures were mild, at first, but grew steadily worse as the months wore on. Enrique's parents were advised by a pediatric neurologist that he should not be administered any more pertussis vaccinations. By January 1998, Enrique's seizures had become uncontrollable by medication. In July 1998, an interdisciplinary team determined that Enrique had an IQ of 63 and exhibited significant language and developmental delays.

Vaccine Act Claim

The Andreu family filed a Vaccine Act claim on Oct. 26, 1998, alleging that the DPT vaccine Enrique received caused his seizure disorder. In support of their claim, they submitted a letter from Marcel Deray, M.D., Enrique's treating physician, who stated: “Enrique is a patient I have followed since 11/22/96. He has an encephalopathy and seizures. There has been no neurological cause found for his encephalopathy and no other explanation other than the DPT immjunization given to him when he was an infant.”

The family also submitted the expert report of neurologist Carlo Tornatore, M.D. Dr. Tornatore opined that the DPT vaccinaiton that Enrique received on Oct. 31, 1995, “resulted in an acute encephalopathy and seizures secondary to the direct toxicity of the components in the whole-cell pertussis vaccine.” Dr. Tornatore advised that the DPT vaccine contains pertussis toxins and endotoxins, which can cross the brain-blood barrier, causing overstimulation of the nerves and supporting cells of the brain, and provoking seizures. He cited to six articles showing that the pertussis toxin can be used to induce “excitotoxicity” in the brains of animals. He also noted that those infected with the pertussis virus can experience encephalopathy and seizures and that this “wild-type infection is actually in some ways reproduced by the vaccination.”

Government Expert

The government's expert, Joel Herskowitz, M.D., disputed Dr. Tornatore's theory and asserted that the medical “literature does not support the occurrence of afebrile focal seizures as a consequence of a DPT whole-cell immunization.” He opined that if the pertussis vaccine had indeed attacked Enrique's brain, there should have been additional neurological symptoms, including generalized, as opposed to focal, seizures, as well as personality changes shortly following the vaccination. On cross-examination, however, Dr. Herskowitz allowed that anything that might cause a “devastating” injury to the brain might also be able to cause a “smaller amount of brain injury in a smaller area of the brain.”

The Decision

After a decision in favor of the government and a subsequent appeal, the case was returned to the Special Master, who again denied compensation to the Andreu family. The Court of Federal Claims concurred, and the appeal to the Federal Circuit followed.

The standard of review in the Federal Circuit from a judgment in the Court of Federal Claims in a Vaccine Act case is “clear error.” The Andreu case, authored by Circuit Judge Haldane Robert Mayer, found that the special master's decision was clearly erroneous in its inconsistency with two previous Federal Circuit rulings: Althen v. Secretary of Health and Human Services, 418 F.3d 1274 (Fed. Cir. 2005); and Capizzano v. Secretary of Health and Human Services, 440 F. 3d 1317 (Fed. Cir. 2006). Stated the court, “Three fundamental errors infected the special master's decision to deny Enrique compensation. First, the special master incorrectly determined that the testimony of Enrique's treating physicians was insufficient to establish 'a logical sequence of cause and effect' between the DPT vaccine Enrique received on Oct. 31, 1995, and the seizure he experienced one day later. Second, she imposed upon the Andreuses an elevated evidentiary burden, requiring them to submit conclusive proof in the medical literature linking afebrile seizures to components in the whole-cell pertussis vaccine. Finally, the special master erroneously determined that Enrique's 'clinical picture' precluded a finding that his seizure disorder was caused by an injury to the brain from the DPT inoculation.”

The court concluded by stating, “The DPT vaccine leaves no 'footprint' evidencing that it was the catalyst for a particular injury. Almeida, 1999 U.S. Claims LEXIS 294, at *31. Thus, the function of a special master is not to 'diagnose' vaccine-related injuries, but instead to determine 'based on the record evidence as a whole and the totality of the case, whether it has been shown by a preponderance of the evidence that a vaccine caused the child's injury.' Knudsen v. Sec'y of Health & Human Servs., 35 F.3d at 549 [citing Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed.Cir. 1994)]. Here, the totality of the evidence ' including the striking temporal connection between the vaccine and Enrique's initial seizure, the testimony of treating physicians, and the biologic and scientific plausibility of Tornatore's theory of causation ' are sufficient to meet the Vaccine Act's preponderant evidence standard. Since the government has proffered no alternative cause for Enrique's seizures, see 42 U.S.C. ' 300aa-13(a)(1), the Andreus are entitled to compensation under the Vaccine Act.” The findings were thus reversed and the case remanded for determination of damages.

Hope for Autism Claimants And Others

The Federal Circuit ruling in the Andreu case comes in the wake of three special masters' initial rejection of claims in three autism test cases, in an omnibus proceeding of more than 5,000 cases. Those cases claim that the measles, mumps, rubella (MMR) vaccine and a vaccine containing mercury in the preservative thimerosal caused autism in the claimants, whether administered separately or simultaneously. Appeals have been filed in all three cases. Oral arguments for two of those appeals are to take place this summer, and one wrapped up in June. The Federal Claims court has yet to rule on three other test cases involving autism injury claims.

Like the claimant in Andreu, the claimants in the three autism test cases were denied benefits largely because they could not scientifically prove a causal link between the vaccines and the injuries complained of. However, the Andreu decision says that the special masters can't require too high of a burden of proof from plaintiffs because it's a remedial compensation program, said Cliff Shoemaker of Vienna, Va.-based Shoemaker & Associates, who represented the injured party who appealed to the Federal Circuit. “It's a no-fault compensation program designed to compensate people injured by vaccines,” he said. “But it's a very adversarial and litigious [process involving] complex litigation. It's not what Congress intended.”

The Justice Department represented the Health and Human Services secretary in the case, and spokesman Charles Miller said the agency declined to comment.

Reaction from Vaccine Claim Attorneys

The special masters are very protective of vaccines and “require too much science to prove a case,” said vaccine lawyer Kevin Conway of Boston-based Conway, Homer & Chin-Caplan. “It seems that petitioners have to go all the way to the Federal Circuit to get relief,” Conway said. “[The ruling is] again saying you don't need scientific certainty to prove the case. You need legal evidence.”

Conway, whose firm is handling two of the three autism cases, says the Andreu case “does give us hope” that the special masters will be more receptive to claims in the future.

The standards laid out in prior cases are particularly important in DPT cases because residual seizure disorder is no longer on the Vaccine Injury Table, but claimants can make causation in fact claims, said Robert J. Krakow, a Garden City, NY, lawyer, who has a vaccine injury specialty.

The Vaccine Injury Table lists medical conditions and injuries that the compensation program assumes are caused by vaccines, and a time period after the vaccine when the condition must appear in order for the claimant to collect compensation. “You have to prove a medical theory causally connected to the vaccine and the injury, but it doesn't have to be accepted as proven, and you don't have to reach scientific causality,” Krakow said. “It's a legal definition of causation. You have to prove that the medical theory is plausible.”

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

A recent U.S. Court of Appeals for the Federal Circuit decision reversing the U.S. Court of Federal Claims' denial of a vaccine injury claim highlights the widening gulf between the Federal Circuit and Federal Claims court on vaccine cases. On June 18, the Federal Circuit reversed the Federal Claims court's decision to deny the petitioner compensation under the National Vaccine Injury Compensation Program. Andreu v. Secretary of Health and Human Services, — F.3d —-, 2009 WL 1688231 (C.A.Fed. 6/18/09).

The Case

The vaccine compensation program is a no-fault system for injury claims from a variety of vaccines. The U.S. Department of Health and Human Services administers the program with the U.S. Department of Justice and the U.S. Court of Federal Claims in Washington. Special masters hear cases filed at the Federal Claims Court, but either side can appeal rulings to the court and ultimately to the Federal Circuit.

The Andreu case, brought on behalf of Enrique Andreu, alleged that he began having seizures in late 1995, the day after receiving a diphtheria, whole-cell pertussis and tetanus (DPT) vaccine at the age of eight weeks. The seizures were mild, at first, but grew steadily worse as the months wore on. Enrique's parents were advised by a pediatric neurologist that he should not be administered any more pertussis vaccinations. By January 1998, Enrique's seizures had become uncontrollable by medication. In July 1998, an interdisciplinary team determined that Enrique had an IQ of 63 and exhibited significant language and developmental delays.

Vaccine Act Claim

The Andreu family filed a Vaccine Act claim on Oct. 26, 1998, alleging that the DPT vaccine Enrique received caused his seizure disorder. In support of their claim, they submitted a letter from Marcel Deray, M.D., Enrique's treating physician, who stated: “Enrique is a patient I have followed since 11/22/96. He has an encephalopathy and seizures. There has been no neurological cause found for his encephalopathy and no other explanation other than the DPT immjunization given to him when he was an infant.”

The family also submitted the expert report of neurologist Carlo Tornatore, M.D. Dr. Tornatore opined that the DPT vaccinaiton that Enrique received on Oct. 31, 1995, “resulted in an acute encephalopathy and seizures secondary to the direct toxicity of the components in the whole-cell pertussis vaccine.” Dr. Tornatore advised that the DPT vaccine contains pertussis toxins and endotoxins, which can cross the brain-blood barrier, causing overstimulation of the nerves and supporting cells of the brain, and provoking seizures. He cited to six articles showing that the pertussis toxin can be used to induce “excitotoxicity” in the brains of animals. He also noted that those infected with the pertussis virus can experience encephalopathy and seizures and that this “wild-type infection is actually in some ways reproduced by the vaccination.”

Government Expert

The government's expert, Joel Herskowitz, M.D., disputed Dr. Tornatore's theory and asserted that the medical “literature does not support the occurrence of afebrile focal seizures as a consequence of a DPT whole-cell immunization.” He opined that if the pertussis vaccine had indeed attacked Enrique's brain, there should have been additional neurological symptoms, including generalized, as opposed to focal, seizures, as well as personality changes shortly following the vaccination. On cross-examination, however, Dr. Herskowitz allowed that anything that might cause a “devastating” injury to the brain might also be able to cause a “smaller amount of brain injury in a smaller area of the brain.”

The Decision

After a decision in favor of the government and a subsequent appeal, the case was returned to the Special Master, who again denied compensation to the Andreu family. The Court of Federal Claims concurred, and the appeal to the Federal Circuit followed.

The standard of review in the Federal Circuit from a judgment in the Court of Federal Claims in a Vaccine Act case is “clear error.” The Andreu case, authored by Circuit Judge Haldane Robert Mayer, found that the special master's decision was clearly erroneous in its inconsistency with two previous Federal Circuit rulings: Althen v. Secretary of Health and Human Services , 418 F.3d 1274 (Fed. Cir. 2005); and Capizzano v. Secretary of Health and Human Services , 440 F. 3d 1317 (Fed. Cir. 2006). Stated the court, “Three fundamental errors infected the special master's decision to deny Enrique compensation. First, the special master incorrectly determined that the testimony of Enrique's treating physicians was insufficient to establish 'a logical sequence of cause and effect' between the DPT vaccine Enrique received on Oct. 31, 1995, and the seizure he experienced one day later. Second, she imposed upon the Andreuses an elevated evidentiary burden, requiring them to submit conclusive proof in the medical literature linking afebrile seizures to components in the whole-cell pertussis vaccine. Finally, the special master erroneously determined that Enrique's 'clinical picture' precluded a finding that his seizure disorder was caused by an injury to the brain from the DPT inoculation.”

The court concluded by stating, “The DPT vaccine leaves no 'footprint' evidencing that it was the catalyst for a particular injury. Almeida, 1999 U.S. Claims LEXIS 294, at *31. Thus, the function of a special master is not to 'diagnose' vaccine-related injuries, but instead to determine 'based on the record evidence as a whole and the totality of the case, whether it has been shown by a preponderance of the evidence that a vaccine caused the child's injury.' Knudsen v. Sec'y of Health & Human Servs. , 35 F.3d at 549 [citing Knudsen v. Sec'y of Health & Human Servs. , 35 F.3d 543 (Fed.Cir. 1994)]. Here, the totality of the evidence ' including the striking temporal connection between the vaccine and Enrique's initial seizure, the testimony of treating physicians, and the biologic and scientific plausibility of Tornatore's theory of causation ' are sufficient to meet the Vaccine Act's preponderant evidence standard. Since the government has proffered no alternative cause for Enrique's seizures, see 42 U.S.C. ' 300aa-13(a)(1), the Andreus are entitled to compensation under the Vaccine Act.” The findings were thus reversed and the case remanded for determination of damages.

Hope for Autism Claimants And Others

The Federal Circuit ruling in the Andreu case comes in the wake of three special masters' initial rejection of claims in three autism test cases, in an omnibus proceeding of more than 5,000 cases. Those cases claim that the measles, mumps, rubella (MMR) vaccine and a vaccine containing mercury in the preservative thimerosal caused autism in the claimants, whether administered separately or simultaneously. Appeals have been filed in all three cases. Oral arguments for two of those appeals are to take place this summer, and one wrapped up in June. The Federal Claims court has yet to rule on three other test cases involving autism injury claims.

Like the claimant in Andreu, the claimants in the three autism test cases were denied benefits largely because they could not scientifically prove a causal link between the vaccines and the injuries complained of. However, the Andreu decision says that the special masters can't require too high of a burden of proof from plaintiffs because it's a remedial compensation program, said Cliff Shoemaker of Vienna, Va.-based Shoemaker & Associates, who represented the injured party who appealed to the Federal Circuit. “It's a no-fault compensation program designed to compensate people injured by vaccines,” he said. “But it's a very adversarial and litigious [process involving] complex litigation. It's not what Congress intended.”

The Justice Department represented the Health and Human Services secretary in the case, and spokesman Charles Miller said the agency declined to comment.

Reaction from Vaccine Claim Attorneys

The special masters are very protective of vaccines and “require too much science to prove a case,” said vaccine lawyer Kevin Conway of Boston-based Conway, Homer & Chin-Caplan. “It seems that petitioners have to go all the way to the Federal Circuit to get relief,” Conway said. “[The ruling is] again saying you don't need scientific certainty to prove the case. You need legal evidence.”

Conway, whose firm is handling two of the three autism cases, says the Andreu case “does give us hope” that the special masters will be more receptive to claims in the future.

The standards laid out in prior cases are particularly important in DPT cases because residual seizure disorder is no longer on the Vaccine Injury Table, but claimants can make causation in fact claims, said Robert J. Krakow, a Garden City, NY, lawyer, who has a vaccine injury specialty.

The Vaccine Injury Table lists medical conditions and injuries that the compensation program assumes are caused by vaccines, and a time period after the vaccine when the condition must appear in order for the claimant to collect compensation. “You have to prove a medical theory causally connected to the vaccine and the injury, but it doesn't have to be accepted as proven, and you don't have to reach scientific causality,” Krakow said. “It's a legal definition of causation. You have to prove that the medical theory is plausible.”

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