In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-1057V
Filed: March 13, 2015
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H.S., by his parents and natural *
guardians, GREGORY and SANDRA *
SIMPSON, *
*
Petitioner, * Finding of Fact; Six Month Requirement;
v. * Special Processing Unit (SPU)
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
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Renee Gentry, Shoemaker, Gentry & Knickelbein, Vienna, VA, for petitioner.
Alexis Babckock, U.S. Department of Justice, Washington, D.C., for respondent.
ORDER and RULING ON FACTS 1
Vowell, Special Master:
On October 29, 2014, Gregory and Sandra Simpson [“petitioners”] filed a petition
for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C.
§300aa-10, et seq, [the “Vaccine Act” or “Program”] on behalf of their minor son, H.S.
The petition alleges that following the administration of tentanus, diptheria and acellular
pertussis (“Tdap”) and meningococcal vaccines on July 25, 2012, H.S. experienced
syncope and fell to the floor fracturing his skull. Petition at 1. The case was assigned to
the Special Processing Unit [“SPU”].
I. Procedural History
On November 20, 2014, an initial status conference was held with the staff
attorney managing this case. During the status conference, it was noted that the
1 Because this unpublished ruling contains a reasoned explanation for the action in this case, it will be
posted on the United States Court of Federal Claims' website, in accordance with the E-Government Act
of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). In accordance with Vaccine Rule
18(b), petitioners have 14 days to identify and move to redact medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified
material fits within this definition, I will redact such material from public access.
records filed to that date did not readily identify any physical manifestation of H.S.’s
injury lasting at least six months. See Order, February 2, 2015 (ECF No. 20).
Petitioner’s counsel confirmed that petitioners were relying on the fact that H.S. was
under medical restriction from certain physical activities to meet the Vaccine Act’s
statutory six month threshold. (Id.) Petitioners subsequently completed the record and
filed their statement of completion on January 9, 2015. See Statement of Completion
(ECF No. 18).
On January 12, 2015, respondent’s counsel informally requested a fact
determination indicating whether H.S.’s injury persisted for at least six months. See
ECF No. 20. On February 2, 2015, I ordered the parties to file a joint statement
indicating what facts are agreed upon and what facts, if any, are in dispute. Id. The
parties filed their report on March 12, 2015. See Joint Status Report (ECF No. 21).
II. Fact History
According to the parties’ joint report, the following facts are undisputed (see ECF
No. 21):
H.S. received his Tdap and meningococcal vaccinations on July 25, 2015. Ex. 4-
1, p. 14. After receiving those vaccinations, he experienced an episode of syncope and
hit the back of his head. Id., p. 36. At urgent care, a head CT showed a nondisplaced
right occipital skull fracture without bleeding and a neck CT showed a fracture along the
right lateral mass of C1 vertebra, extending into vertebral foramen. Id., pp. 38-39. The
latter finding was considered questionable. Id.
H.S. was referred to Westchester Medical Center for further evaluation and was
hospitalized overnight. See generally Ex. 3. A brain MRI was normal and a C-Spine
MRI showed mild disk space desiccation which was thought to be unrelated to his
syncope episode. Id., pp. 23-24. Following observation, Dr. Michael Tobias discharged
H.S. home with a hard neck collar. Id., p. 3. His injuries were believed to be most likely
caused by a reaction to Menactra. Id., p. 44.
In a letter dated August 15, 2012, H.S.’s pediatrician, Dr. Richard Fuchs,
indicated that H.S. would remain in a neck brace through the middle of September of
that year. Ex. 6, p. 23. Dr. Fuchs further noted that “Following [H.S.]’s confinement to
the neck brace, it will still be medically necessary to excuse him from gym, recess and
sports for an additional six to eight week period . . .Due to the risk of serious
consequences if H.S. were to be reinjured, it will be medically necessary to provide a
one-on-one aid for H.S. while he is in school for the initial six-eight weeks after his
immobilizing brace is removed.” Id.
On September 6, 2012, H.S. experienced a second episode of syncope while at
school. Ex. 2, pp. 16-18. He was sent to the hospital, but was discharged after a normal
physical examination. Id. At a subsequent well-child visit on October 27, 2012, Dr.
Stuart Tashman felt that the September syncope episode was caused by H.S.’s neck
collar being too tight and compromising circulation. Ex. 1, p. 2. Although H.S. had no
headaches, weakness, neck pain, and was not taking any medication, Dr. Tashman
noted that H.S. “is not allowed to play, gym, ride a bike or play any sports for the
following year.” Id.
H.S. saw Dr. Tobias for a follow-up on April 1, 2013. Ex. 6, p. 5. He was doing
well clinically and had recovered from his injury. Id. Dr. Tobias cleared H.S. to return to
gym class at that time. Id. H.S. was later cleared to resume all activities without
restriction on September 30, 2013. Ex. 1, p. 12.
III. Discussion
Under the Vaccine Act, a petition for compensation must contain “supporting
documentation, demonstrating that the person who suffered [a vaccine related injury] ...
suffered the residual effects or complications of such illness, disability, injury, or
condition for more than 6 months after the administration of the vaccine.” 42 U.S.C. §
300aa–11(c)(1)(D)(i). The burden of establishing, by a preponderance of the evidence,
the persistence of a vaccine-caused injury for longer than six months is borne by
petitioners. Song v. Sec'y of Health & Human Servs., 31 Fed. Cl. 61, 65–66, aff'd, 41
F.3d 1520 (Fed.Cir.1994).
I have previously noted that “an increased risk of a recurrence without an actual
recurrence of a condition is not medically recognized as a ‘residual effect’ and is not a
residual effect within the meaning of § 300aa-11(c)(1)(D)(i) of the Vaccine Act.” Parsley
v. Sec’y of Health & Human Servs., 08-781V, 2011 WL 2463539, *5 (Fed. Cl. Spec.
Mstr., May 27, 2011). In Parsley, petitioners’ child experienced an intussusception
following a rotovirus vaccination that resolved without surgical intervention in fewer than
six months. Id., *4. Petitioners argued that, despite the lack of any recurrence of
intussusception, their child remained at an increased risk for developing the condition
again in the future, and that this risk constituted a “residual effect” of the injury. Id., *5. I
disagreed.
More recently, however, a fellow special master has persuasively noted that
“because determining the existence, or lack thereof, of clinical symptoms of a disease is
the most obvious and logical means of evaluating the duration of the ‘residual effects or
complications’ of that disease, it is understandable that the concepts are often
conflated. However, ‘residual effects or complications’ and ‘symptomatic’ are not
synonymous; one can suffer from a disease without exhibiting any clinical signs
thereof.” Faup v. Sec’y of Health & Human Servs., 12-87V, 2015 WL 443802, *4 (Fed.
Cl. Spec. Mstr., January 23, 2015). In Faup, the parties agreed that the petitioner was
asymptomatic at least in part because she was being medicated to prevent the
recurrence of her symptoms. The special master concluded that the ongoing need for
medication to prevent a relapse constituted a “residual effect” of her injury. Id.
In the instant case, H.S. remained in a neck collar only for about 12 weeks, or
until October of 2012, well shy of the 6 months necessary. Ex. 1, p. 2; Ex. 7, p. 6. After
that, there is no evidence that he experienced any headaches, pain or outward sign of
injury. Nothing in the medical records, however, indicates that his doctors believed that
the removal of the neck brace constituted the resolution of his injury. Indeed, at the
time the collar was removed his doctor indicated based on a CT scan that “the fracture
appears to be healing.” Ex. 7, p. 6. As of April 1, 2013, well beyond six months after the
implicated vaccination, H.S.’s medical records still indicated that a further CT scan was
viewed as necessary to confirm whether the fracture site had fully healed. Ex. 7, p. 8.
Moreover, H.S.’s doctors stressed that he was to remain restricted from activity
after his neck collar was removed. Ex. 6, p. 23; Ex. 7, p. 6. His pediatrician in particular
noted that this was “medically necessary” and that the precautions being taken were
“due to the risk of serious consequences if H.S. were to be reinjured.” Ex. 6, p. 23.
Although H.S.’s restriction from activity was initially only to last 6 to 8 weeks, it was
subsequently extended to one year (ex. 1, p. 2) and indeed was not fully and finally
lifted until September 30, 2013 (ex. 1, p. 12). Thus, H.S.’s doctors clearly believed that
H.S. remained in a vulnerable state and had not returned to his pre-vaccination
condition of health long after he was allowed to remove the neck collar.
These facts indicate that, like the Faup case, H.S.’s lack of outward symptoms of
his injury are not indicative of the length of time his injury persisted. Rather, the records
make clear that H.S.’s doctors were concerned about the presence of his skull fracture
long after he stopped being symptomatic. That is, like Faup, H.S.’s doctors believed
that the restriction from activity was medically necessary as part of H.S.’s treatment
precisely to ensure that further consequences of his injury would not manifest in the
future. In that sense, H.S.’s restriction from certain physical activities is precisely
analogous to the Faup petitioner’s ongoing need for medication.
Despite the reference in the records to a “risk” of re-injury, this case is far
different from Parsley. In Parsley, the petitioners sought to rely on the increase in risk
itself as a residual effect of their child’s injury. Here, the medical restriction due to
increased risk of re-injury constitutes evidence that H.S.’s doctors did not believe his
skull fracture had fully resolved in the first instance.
Thus, I find based on the record as a whole that petitioners have
established that H.S. suffered residual effects of his skull fracture for longer than
six months.
IT IS SO ORDERED.
s/Denise K. Vowell
Denise K. Vowell
Chief Special Master