­Barclay v. HHS, Case No. 07-605V (Fed. Cl. Jul. 10, 2015) (Bruggink, J)

This case was tried jointly with Santini v. HHS, also in this summary.  Both cases involved an allegation that the DTaP vaccine triggered or worsened Dravet’s syndrome/SMEI in a child with an SCN1A mutation.

Testifying for the petitioner had been Jean-Ronel Corbier, a pediatric neurologist.  As in the prior SCN1A cases, testifying for Respondent were Max Wiznitzer, a pediatric neurologist, and Gerald Raymond, a neurologist and geneticist.

The baby was demonstrated to have a severe de novo mutation of the SCN1A gene, a known cause of Dravet’s and the subject of much prior litigation in the program.  Petitioner contended that the vaccination triggered the earlier onset of the manifestations of Dravet and that those symptoms were, on a continuing basis, more serious than they otherwise would have been.

On appeal, the court noted the difficulty in applying the Loving analysis in a case involving a genetic mutation.  It was undisputed that the vaccine caused the fever which preceded the initial seizure on the day of vaccination.

There is thus no question that [the baby’s] condition immediately prior to vaccination was that he was free of fever and seizures, and that after the vaccination he had a fever (briefly), but continued to have seizures. Under these circumstances, determining whether or not the causation test is met depends on how the question is framed. Is it sufficient that there is a connection between the vaccination and the first seizure, or must the first seizure have had an impact on [the baby’s] ultimate prognosis? What specific condition must have persisted at least six months to establish causation, and what must petitioner prove, if anything, with respect to whether the genetic abnormality alone explains the ongoing seizures?

In the trial court, petitioner had presented three overlapping theories of causation, 1) that individuals with an SCN1A mutation are vulnerable or susceptible to developing an adverse reaction to the DTaP vaccine, 2) that vaccines cause Dravet syndrome to manifest earlier by bringing about seizures before they would have occurred otherwise, and 3) that “vaccines cause a more prolonged seizure and the prolonged seizure inflicts additional damage.”  Respondent argued the mutation was a factor unrelated.

The Special Master did not analyze all six Loving prongs, but rather focused on prong four, the equivalent of Althen prong oneThe court was not persuaded by petitioner’s theory that the vaccination aggravated the symptoms of the SCN1A mutation, and he accepted respondent’s argument that [the baby’s] presentation of Dravet syndrome was completely explained by his genetic mutation. The Special Master thus accepted respondent’s proof of two things, either of which would be inconsistent with a recovery: that the vaccination did not cause any brain damage making the onset of Dravet more serious; and that the manifestation of the SCN1A mutation would not have been any different if the vaccine had not been administered. The first finding was inconsistent with petitioner’s case in chief. The second accepted respondent’s defense of factor unrelated.

Regarding whether the child’s condition was worse after the vaccination, i.e. aggravated, the Special Master held that petitioner had not established that, but for the vaccine, [the baby’s] outcome would not be as severe. “According to the Special Master, Dr. Corbier was unable to provide any meaningful information about how [the baby’s] present condition was different than a typical presentation of Dravet syndrome. Instead, the Special Master found respondent’s expert testimony that vaccination does not affect Dravet syndrome to be more persuasive.”

Following this initial seizure, the baby’s tests results were normal and upon discharge from the hospital, he was in good condition. According to the Special Master, the effects of this initial fever and isolated seizure did not continue for more than six months.  Rather than a sequela of the initial seizure, the Dravet’s syndrome that the baby developed was the result of his mutation.

The reviewing court noted that there were two ways to analyze whether a significant aggravation occurred, (i.e. the before/after analysis), in the context of a preexisting genetic mutation.  If the significant aggravation is alleged to be the ongoing seizures, the baby’s condition prior to vaccination included the genetic abnormality and the inevitable Dravet syndrome. There is thus no significant aggravation and no causal connection.

On the other hand, if the initial fever and seizure are proposed as the aggravation, there is a causal connection but no significance to the aggravation. The seizure was short-lived. The baby had recovered from this episode within a few days, and the injury did not meet the six-month requirement.

Petitioner might have established causation by proving that the baby’s “before” condition was that of a child who would ultimately develop seizures, but who, after the vaccination, was a child whose seizures and developmental delay were more severe because of the vaccine. However, the Special Master found Respondent’s experts more persuasive on this point, and the reviewing court found no basis for overturning his analysis.

Petitioner argued on appeal that the Special Master elevated her burden of proof by requiring her to establish that the vaccine affected the child’s ultimate outcome. The court held that Petitioner was correct that it was not her burden to prove what Matthew’s ultimate prognosis would have been, but for the vaccination. However, the reviewing court found that the trial court did not actually require that proof:

Indeed, even if the ultimate prognosis were the same with and without the vaccination, there would still be room, presumably, to argue that for at least six months the child’s condition was significantly worse than it would have been without the vaccination. We view the Special Master’s statements concerning ultimate outcome, however, in the context of respondent’s theory of alternative causation. In the circumstances of this case, the “ultimate” outcome and the significant aggravation petitioner attempted to prove were one and the same and neither can be attributed to the vaccination.

Vaccine Case Reviews DTaP – SCN1A – Dravet’s syndrome/SMEI – Affirmed Denial of Compensation