Santacroce v. Secretary of Health and Human Services ( 2016 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 15-555
December 1, 2016
Not for Publication
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SABRINA SANTACROCE, on behalf *
of her minor child, J.R., *
*
Petitioner, *
* Varivax, Prevnar, and hepatitis A
v. * vaccines; dystonia musculorum
* deformans; petitioner’s motion for
SECRETARY OF HEALTH * a decision dismissing petition
AND HUMAN SERVICES, *
*
Respondent. *
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Andrew D. Downing, Phoenix, AZ, for petitioner.
Sarah C. Duncan, Washington, DC, for respondent.
MILLMAN, Special Master
DECISION 1
On June 1, 2015, petitioner filed a petition under the National Childhood Vaccine Injury
Act, 42 U.S.C. §§ 300aa-10–34 (2012), alleging that Varivax, Prevnar, and hepatitis A
1
Because this unpublished decision contains a reasoned explanation for the special master’s action in this
case, the special master intends to post this unpublished decision on the United States Court of Federal
Claims’ website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012)
(Federal Management and Promotion of Electronic Government Services). Vaccine Rule 18(b) states that
all decisions of the special masters will be made available to the public unless they contain trade secrets
or commercial or financial information that is privileged and confidential, or medical or similar
information whose disclosure would constitute a clearly unwarranted invasion of privacy. When such a
decision is filed, petitioner has 14 days to identify and move to redact such information prior to the
document=s disclosure. If the special master, upon review, agrees that the identified material fits within
the banned categories listed above, the special master shall redact such material from public access.
vaccinations her son J.R. received on March 8, 2013 caused him dystonia musculorum
deformans. 2 Pet. at ¶¶ 2, 4.
On December 1, 2016, petitioner filed a Motion for a Decision Dismissing Petition,
stating, “Petitioner recognizes that she will likely be unable to meet her burden of proof as to
scientific and medical causation under the record as it exists and/or establish that J.R. is entitled
to compensation in the Vaccine Program.” Mot. at ¶ 5. In addition, petitioner states “to proceed
further would be unreasonable and would waste the resources of the Court, the Respondent, and
the Vaccine Program.” Id. at ¶ 6.
The undersigned GRANTS petitioner’s Motion for a Decision Dismissing Petition and
DISMISSES this case.
FACTS
J.R. was born on July 1, 2011.
On April 27, 2012, J.R. received Pentacel (DTaP, HiB, and IPV vaccines), Prevnar, and
hepatitis B vaccines. Med. recs. Ex. 9, at 208-09. Eight days later, on May 5, 2012, J.R. was
taken to Palm Bay Hospital Emergency Department. Med. recs. Ex. 8, at 21. PA-C Lauren
Poulson wrote that according to his mother J.R. was acting weird, making motions as if he were
in abdominal pain. He had been fussy all day. He had vomited three times. However, in the
emergency department, J.R. was behaving normally. He had decreased appetite. He had
received his vaccinations the prior week. Id.
If the April 27, 2012 vaccinations caused J.R.’s dystonia musculorum deformans whose
onset was within five days, the three-year statute of limitations would have run in this case since
petitioner filed her petitioner more than 36 months post-vaccination. Then her only recourse
would have been to allege that subsequent vaccinations in 2013 significantly aggravated J.R.’s
pre-existing dystonia musculorum deformans. Another issue is how a vaccine could cause a
hereditary condition (see n.2 for the definition of “dystonia musculorum deformans”).
On March 8, 2013, J.R. received Varivax, Prevnar, and hepatitis A vaccines. Id. at 151.
Petitioner alleged that later that day J.R. had fever, mouth sores, and abnormal movements.
2
Dystonia musculorum deformans is “a rare hereditary type of generalized dystonia characterized by
involuntary, irregular, clonic contortions of the muscles of the trunk and limbs, especially when a person
is walking, which twist the body forward and sideways in a grotesque fashion.” Dorland’s Illustrated
Medical Dictionary 583 (32d ed. 2012).
2
On August 14, 2013, J.R. received DTaP, HiB, and hepatitis B vaccines. Id. at 129.
Petitioner alleged that on the same day, J.R. slept three hours and, two days later, had no
appetite.
On September 6, 2013, a VAERS form was filed, stating that J.R. had a reaction to his
August 14, 2013 vaccinations, consisting of abnormal tongue movements, seizure-like
symptoms, such as legs straightening and twisting his arms, and screaming in pain. Med. recs.
Ex. 12, at 1.
Neurological examination and a prolonged EEG showed that J.R. does not have a
neurological condition, leading to the conclusion that J.R. was normal neurologically, had
normal developmental milestones, and did not have seizures. Med. recs. Ex. 7, at 15. J.R. has a
history of temper tantrums, and his abnormal movements and crying appeared to be behavioral.
Id. at 30. When J.R. had his episodes, he was conscious and verbally responded to petitioner,
behavior that was inconsistent with seizure activity. Id. According to petitioner, emotional
stimuli frequently triggered J.R.’s episodes. Id. Dr. Christine Bessett stated, “This is likely a
psychologic problem and family/patient would likely benefit from a behavioral specialist
referral.” Id. at 10.
DISCUSSION
To satisfy her burden of proving causation in fact, petitioner must prove by preponderant
evidence: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical
sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a
showing of a proximate temporal relationship between vaccination and injury.” Althen v. Sec’y
of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit quoted its opinion
in Grant v. Secretary of Health and Human Services, 956 F.2d 1144, 1148 (Fed. Cir. 1992):
A persuasive medical theory is demonstrated by “proof of a logical
sequence of cause and effect showing that the vaccination was the
reason for the injury[,]” the logical sequence being supported by
“reputable medical or scientific explanation[,]” i.e., “evidence in
the form of scientific studies or expert medical testimony[.]”
Althen, 418 F.3d at 1278.
Without more, “evidence showing an absence of other causes does not meet petitioners’
affirmative duty to show actual or legal causation.” Grant, 956 F.2d at 1149. Mere temporal
association is not sufficient to prove causation in fact. Id. at 1148.
Petitioner must show not only that but for Varivax, Prevnar, and hepatitis A vaccinations,
J.R. would not have had dystonia musculorum deformans, but also that the vaccines were a
substantial factor in causing his dystonia musculorum deformans. Shyface v. Sec’y of HHS, 165
3
F.3d 1344, 1352 (Fed. Cir. 1999). The supposed onset of J.R.’s dystonia musculorum deformans
is unclear from the medical records. The fact that his medical examinations show him to be
neurologically normal casts doubt on any assertion that he has a hereditary neurologic condition
or seizures. Moreover, treating doctors diagnose his abnormal behavior to temper tantrums. The
VAERS form asserting seizures does not invalidate J.R.’s medical test results and physical
examinations, leading his treating doctors to conclude that he was neurologically normal.
The Vaccine Act does not permit the undersigned to rule for petitioner based on her
claims alone, “unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa-
13(a)(1) (2006). The medical records do not support petitioner’s allegations. Petitioner has not
filed an expert report in support of her allegations.
CONCLUSION
The undersigned GRANTS petitioner’s Motion for a Decision Dismissing Petition and
DISMISSES this case. 3
IT IS SO ORDERED.
December 1, 2016 s/Laura D. Millman
DATE Laura D. Millman
Special Master
3
Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or
jointly, filing a notice renouncing the right to seek review.
4