In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 13-102V
September 17, 2013
Reissued redacted on October 1, 2013
Not to be Published
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CHONDRA WILLIAMS and ERIK *
WILLIAMS, natural parents and guardians *
ad litem for J.W., a minor, *
*
Petitioners, *
*
v. * Thin corpus callosum; no expert
* for petitioners; petitioners’
SECRETARY OF HEALTH * motion for a ruling on the record
AND HUMAN SERVICES, *
*
Respondent. *
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Carol L. Gallagher, Linwood, NJ, for petitioners.
Alexix B. Babcock, Washington, DC, for respondent.
MILLMAN, Special Master
DECISION1
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Because this unpublished decision contains a reasoned explanation for the special
master's action in this case, the special master intends to post this unpublished decision on the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's website, in accordance with the E-Government Act of
2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). 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 categories listed above, the special master shall redact such
material from public access. On October 1, 2013, petitioners moved to redacted their child’s
name to his initials. The undersigned grants their motion and so redacts his name to his initials.
On February 14, 2013, petitioners filed a petition under the National Childhood Vaccine
Injury Act, 42 U.S.C. § 300aa–10-34 (2012), alleging that hepatitis B, diphtheria-tetanus-
acellular pertussis (DTaP), haemophilus B influenza (HiB), pneumococcal (Prevnar), and
inactivated polio (IPV) vaccines administered on March 1, 2010 caused their son J.W.’s
hypotonia. Pet. at 1. J.W. was born with a thin corpus callosum. Med. recs. Ex. 9, at 20; Ex. 3,
at 9; Ex. 4, at 31. He had hypotonia, developmental delay, failure to thrive, and cerebral palsy.
Pet. at 1; Med. recs. Ex. 3, at 11; Ex. 1, at 2.
On May 7, 2013, petitioners filed an amended petition, alleging that the March 1, 2010
vaccines significantly aggravated symptoms that began after J.W.’s October 27, 2009
vaccinations, consisting of DTaP, IPV, HiB, hepatitis B, Prevnar, and rotavirus vaccines. Am.
Pet. at 1–2. In addition, petitioners allege that subsequent vaccinations on May 10, 2010, August
6, 2010, September 8, 2010, and March 30, 2011 significantly aggravated J.W.’s condition. Id.
at 1. Petitioners never filed an expert report in support of their allegations.
On September 17, 2013, petitioners moved for a ruling on the record, understanding that
without expert support of their allegations, this case would be dismissed.
The undersigned GRANTS petitioners’ motion for a ruling on the record and dismisses
this case.
FACTS
J.W. was born on August 3, 2009.
On October 27, 2009, he received his first DTaP, first IPV, first HiB, second hepatitis B,
first Prevnar, and first rotavirus vaccines. Med. recs. Ex. 3, at 2.
On March 1, 2010, J.W. received his second DTaP, second IPV, second HiB, second
Prevnar, and third hepatitis B vaccinations. Id. His pediatrician Dr. Yasser Hassane noted at this
visit that J.W. had lack of eye control and contact. Med. recs. Ex. 12, at 1. Dr. Hassane
questioned whether J.W. had autism and recommended his parents take him to a neurologist. Id.
On March 17, 2010, J.W. was diagnosed at Henry Ford Macomb Hospitals with an upper
respiratory infection for the prior three days. Med. recs. Ex. 5 at 564–65. He had a low-grade
fever, but was eating and drinking normally. Id. at 565. His range of symptoms was otherwise
normal. Id. at 560, 563.
On May 5, 2010, J.W. saw his pediatrician Dr. Hassane, who noted that J.W. had
hypotonia. Med. recs. Ex. 3, at 9.
On June 1, 2010, J.W. underwent an EEG, which was normal. Med. recs. Ex. 4, at 85.
2
On June 11, 2010, Katie Garrisi conducted a family interview and psychological
evaluation as part of an investigation for preschool assessment of J.W.’s global developmental
delay. Med. recs. Ex. 9, at 5. J.W.’s mother reported that, at about four to five months of age,
J.W. exhibited behavioral episodes she described as spasms. Id. at 6. (J.W. was four to five
months of age December 2009 to January 2010. His first vaccinations occurred October 27,
2009. His second vaccinations occurred March 1, 2010.) J.W.’s mother gave the same history
of onset of several spasms to both Jean Vandelinder, a physical therapist, and Patricia Cox, an
occupational therapist, also evaluating J.W. on June 11, 2010. Id. at 9, 11.
On June 13, 2010, J.W. had a brain MRI, which showed he had a thin corpus callosum.2
Id. at 20.
On June 22, 2010, J.W. saw his pediatrician, who diagnosed him with hypotonia, poor
eye contact, developmental delay, and a thin corpus callosum. Med. recs. Ex. 3, at 9.
On January 7, 2011, J.W. was at Children’s Hospital of Michigan, where Dr. Charles
Pelshaw, a pediatric physiatrist, took a history from J.W.’s parents that, when J.W. was three to
four months of age, his parents noticed that his developmental progress started to go backwards.
Med. recs. Ex. 9, at 27. Whereas before, he could track with his eyes, he lost this ability. Id.
Whereas before, he could lift his head and roll, he lost this ability. Id. He had generalized
weakness in his upper and lower extremities and his neck and trunk. He clasped his arms and
clenched his muscles. Id. (J.W. was three to four months of age from November to December
2009. His first vaccinations were in October 2009, and his second vaccinations were in March
2010.)
On March 30, 2011, J.W. saw his pediatrician, who diagnosed him with failure to thrive,
cerebral palsy, retardation, and hypotonia. Med. recs. Ex. 3, at 11. J.W. responded to voice and
noise. Id.
On June 20, 2012, J.W. had a brain MRI, which showed not only a thin corpus callosum,
but also incomplete myelination of the corpus callosum and of the most anterior frontal
subcortical white matter. Med. recs. Ex. 4, at 31. He had nonspecific, abnormal T2 increased
hyperintensity within the peritrigonal region, which may have represented an underlying white
matter disease, an inborn error of metabolism, or a prior ischemic event. Id. at 32.
On December 24, 2012, J.W. was at Henry Ford Macomb Hospital, where Dr. Leonard
B. Pollack wrote that J.W. had congenital hypotonia and was recently diagnosed with cerebral
palsy. Med. recs. Ex. 5, at 21. Dr. Pollack recorded that J.W.’s parents gave a history that by
2
The corpus callosum is “an arched mass of white matter, found in the depths of the
longitudinal fissure, composed of three layers of fibers, the central layer consisting primarily of
transverse fibers connecting the cerebral hemispheres . . . .” Dorland’s Illustrated Medical
Dictionary 417 (32d ed. 2012)
3
about four months of age (or about early December 2009, which was about six weeks after his
October 27, 2009 vaccinations and three months before his March 1, 2010 vaccinations), his
parents noted that J.W. was hypotonic and developmentally delayed. Id.
DISCUSSION
To satisfy their burden of proving causation in fact, petitioners 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[.]”
418 F.3d at 1278.
Without more, “evidence showing an absence of other causes does not meet petitioner’s
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.
Petitioners must show not only that but for J.W.’s vaccinations, J.W. would not have had
hypotonia, failure to thrive, cerebral palsy, and developmental delay or these conditions would
not have been as severe, but also that the vaccines were a substantial factor in causing or
significantly aggravating his hypotonia, failure to thrive, cerebral palsy, and developmental
delay. Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999).
Petitioners have not filed an expert report in support of their allegations, and the medical
records do not substantiate their allegations. The Vaccine Act does not permit the undersigned to
rule in favor of petitioners based solely on their allegations, unsupported by medical records or
credible medical opinion. 42 U.S.C. § 300aa-13(a)(1) (2012).
The Federal Circuit has emphasized that special masters are to consider seriously the
opinions of treating physicians. Broekelschen v. Sec’y of HHS, 618 F.3d 1339, 1347 (Fed. Cir.
2010); Andreu v. Sec’y of HHS, 569 F.3d 1367, 1375 (Fed. Cir. 2009); Capizzano v. Sec’y of
HHS, 440 F.3d 1317, 1326 (Fed. Cir. 2006). Here, Dr. Pollack diagnosed J.W. with congenital
hypotonia at Henry Ford Macomb Hospital. Med. recs. Ex. 5 at 21. The radiologist who read
J.W.’s brain MRI on June 20, 2012 attributed his brain abnormalities to a possible inborn error of
4
metabolism. Med. recs. Ex. 4, at 32. The doctors noted he was born with a thin corpus
callosum. Med. recs. Ex. 9, at 20; Ex. 3, at 9; Ex. 4, at 31. Those born with abnormalities of the
corpus callosum can have developmental delay, cerebral palsy, hypotonia, and failure to thrive.
Dawn J. Cardeiro, Agenesis of the Corpus Callosum, Healthline (2005),
http://www.healthline.com/galecontent/agenesis-of-the-corpus-collosum. J.W. has
developmental delay, cerebral palsy, hypotonia, and failure to thrive. None of his treating
physicians attributed these abnormalities to his vaccinations.
Because petitioners have not filed an expert medical report, and the treating doctors’
records offer no support of causation, petitioners have not satisfied the three prongs of Althen:
(1) they have not presented a credible medical theory explaining how these vaccinations caused
or significantly aggravated J.W.’s condition; (2) they have not proved there is a logical sequence
of cause and effect showing that these vaccinations caused or significantly aggravated J.W.’s
condition; and (3) they have not shown that the time interval is medically appropriate to support
a conclusion of causation or significant aggravation. They have failed to make a prima facie
case.
Petitioners’ motion for a ruling on the record is GRANTED. This petition is hereby
DISMISSED.
CONCLUSION
Petitioners’ petition is DISMISSED. In the absence of a motion for review filed
pursuant to RCFC Appendix B, the clerk of the court is directed to enter judgment herewith.3
IT IS SO ORDERED.
September 17, 2013 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.
5