The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 13-562V
January 20, 2015
Not to be Published
******************************************
ISHWAR GOPICHAND and PENNY *
GOPICHAND, as Parents and Guardians *
Ad Litem of C.K.G., *
*
Petitioners, *
*
v. * Hepatitis A vaccine; alleged
* significant aggravation of
SECRETARY OF HEALTH AND * seizures; no expert support;
HUMAN SERVICES, * ruling on the record
*
Respondent. *
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Peter J. Sarda, Raleigh, NC, for petitioners.
Julia W. McInerny, Washington, DC, for respondent.
MILLMAN, Special Master
DECISION1
On August 8, 2013, petitioners filed a petition under the National Childhood Vaccine
Injury Act, 42 U.S.C. § 300aa-10–34 (2006), on behalf of their daughter C.K.G., alleging that
hepatitis A vaccine administered to C.K.G. on August 19, 2010, exacerbated her preexisting
migraines and seizures. Pet. at 2.
1
Because this decision contains a reasoned explanation for the special master’s action in this case, the
special master intends to post this 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, petitioners have 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.
The undersigned assumes that by “exacerbate,” petitioners are claiming that hepatitis A
vaccine significantly aggravated C.K.G.’s preexisting complex migraine headaches and seizures.
The Vaccine Act defines “significant aggravation” in § 300aa-33(4):
The term “significant aggravation” means any change for the
worse in a preexisting condition which results in markedly greater
disability, pain, or illness accompanied by substantial deterioration
of health.
On June 2, 2014, respondent filed her Rule 4(c) Report recommending that compensation
not be awarded in this case. On June 4, 2014, the undersigned held a telephonic status
conference with counsel to discuss respondent’s report. The undersigned issued an Order on
June 4, 2014, setting a deadline of August 29, 2014, for petitioners to file an expert report in
support of their allegations.
On August 13, 2014, petitioners filed a motion for additional time, requesting an
additional 60 days or until October 28, 2014, to find an expert to support their allegations. The
undersigned granted petitioners’ motion on August 13, 2014. On October 22, 2014, petitioners
filed a second motion for additional time, requesting an additional 65 days or until January 5,
2015, to find an expert to support their allegations. The undersigned granted petitioners’ motion
on October 23, 2014. On January 5, 2015, petitioners filed a third motion for additional time,
requesting an additional 10 days or until January 15, 2015, to find an expert to support their
allegations. The undersigned granted petitioners’ motion on January 6, 2014.
On January 15, 2015, petitioners filed a Notice stating that “petitioners are unable to
obtain a witness who can reasonably expect to qualify as an expert under the Althen standards.”
On January 20, 2015, the undersigned held a telephonic status conference with counsel, during
which petitioners’ counsel orally moved for a ruling on the record.
The undersigned GRANTS petitioners’ motion for a ruling on the record and
DISMISSES this case for failure to make a prima facie case of causation and/or significant
aggravation.
FACTS
Pre-vaccination Records
C.K.G. was born on January 8, 2001. Her mother’s pregnancy was complicated with
pregnancy-induced hypertension (“PIH”) and gestational diabetes mellitus (“DM”). Med. recs.
Ex. 1, at 63.
On February 13, 2002, at Jacksonville Children’s Clinic, C.K.G. at 13 months was
diagnosed with esotropia (being cross-eyed). Id. at 155.
2
On August 15, 2002, C.K.G. at 19 months was diagnosed with gross motor delay. Id. at
23.
On August 19, 2002, C.K.G. was evaluated at Onslow Memorial Hospital Department of
Rehabilitation, where physical therapist Leslie A. Mosier noted that C.K.G. at 19 months had
gross motor delays. Id. at 63. C.K.G.’s neuromuscular tone in her upper and lower extremities
was mildly decreased. Id. Her equilibrium was mildly decreased, secondary to poor proximal
strength and control. Id. She had bilateral winged scapulas. Id.
On September 9, 2002, PT Mosier recommended that C.K.G. receive a full speech
language pathology evaluation. Id. at 89.
On February 13, 2003, C.K.G. was at Jacksonville Children’s Clinic, where she was
diagnosed with mild developmental delay, strabismus (with a history of ophthalmologic referral
at six months), gross motor delay likely secondary to decreased lower extremity tone, and
delayed walking. Id. at 24–25. She was referred for a neurology consultation. Id. On the day
before this examination, C.K.G. was diagnosed with hypotonia. Id. at 23.
On June 6, 2006, when C.K.G. was five years old, she was at Jacksonville Children’s
Clinic, complaining that the right side of her head hurt for two hours. Her father, a pediatrician,
said she did not have fever. Id. at 15. A Lab Corp. test on June 6, 2006, showed that C.K.G. had
elevated tryptase, indicating she experienced a systemic mast cell event. Id. at 6. On the same
day, Dr. Dean Batten did a CT scan of C.K.G.’s brain, noting she had a sudden, severe headache
in the right-sided/temple region and a fever of 101.8 degrees. Id. at 45. The CT scan was
normal. Id. On the same day, C.K.G. was carried from home to Onslow Memorial Hospital ED
with a headache and a fever of 101.2 degrees. Id. at 50. She complained of right-sided splitting
headache with fever since noon. Id.
From July 27 to 28, 2006, C.K.G. had an ambulatory EEG under the direction of
neurologist Dr. Christine T. Burch. Id. at 43–44. The EEG was abnormal due to the presence of
a generalized spike in wave and poly spike in wave discharge that was somewhat poorly
organized. Dr. Burch noted, “This indicates most likely primary generalized epilepsy . . . .” Id.
On November 10, 2006, C.K.G. saw a pediatric and adult urologist, Dr. Robert T.
Bennett, for lysis of her labial lesions. Id. at 40.
On April 17, 2007, C.K.G. visited Jacksonville Children’s Clinic, complaining of a
temporal headache. Id. at 4.
On April 23, 2007, C.K.G. had surgery for a fracture of her left arm due to falling off a
balance beam during gymnastics. Id. at 213.
3
On December 3, 2008, C.K.G. visited Jacksonville Children’s Clinic, complaining of
numbness in her hands and right jaw, right-sided headache, and transient weakness that lasted
about five minutes. Id. at 99. She was diagnosed with a probable seizure. Id.
On December 4, 2008, C.K.G. visited East Carolina Neurology, recounting her symptoms
of right jaw pain, left hand weakness, and left distal lower extremity weakness leading to
dragging. Id. at 263. This lasted 15 minutes, and she had a headache afterwards. Id.
The neurologist’s differential diagnosis was seizure, classic migraine, or transient ischemic
attack (“TIA”). Id.
On March 20, 2009, C.K.G. saw Dr. Burch, her neurologist, complaining of weakness on
one side lasting 15 minutes, followed by a headache, which Dr. Burch thought most likely a
classic migraine. Id. at 97. Dr. Burch noted that C.K.G.’s methylenetetrahydrofolate reductase
(“MTHFR”) level was slightly abnormal, for which C.K.G. took folate. Id. Dr. Burch’s
diagnosis was classic migraine involving a neurologic deficit of hemiplegia for 15 minutes. Id.
Post-vaccination Records
On August 19, 2010, C.K.G. received hepatitis A vaccine. Med. recs. Ex. 2, at 1.
On August 20, 2010, C.K.G. visited Pitt County Memorial Hospital. Med. recs. Ex. 5, at
1. A respiratory culture showed moderate gram positive cocci. Id. at 5. A brain MRI done on
the same day was normal. Id. at 6. A chest x-ray done the same day showed streaky opacities in
the right upper lung zone, which might represent atelectasis or possibly developing infiltrate. Id.
at 7. Aspiration was a consideration. Id. Dr. Douglas R. Gallo took a history and physical on
August 20, 2010. Id. at 8–10. After C.K.G.’s vaccination, she ate at Chick Fil A and went
home. Id. at 8. She helped pack a van for her father’s trip and ate lasagna at 7:00 p.m. Id.
C.K.G.’s mother suspected C.K.G. fell behind on her fluids. Id. C.K.G. had not had any of the
G2 Gatorade she normally drank. Id. At 11:15 p.m., while the family was driving, C.K.G. was
in the back seat when she started gurgling and slumped over. Id. Her eyes deviated to the right,
and she drooled. Id. She was not speaking or following commands. Id. There was some
vomitus. Id. She had tonic movements, but no loss of bowel or bladder. Id. This lasted five
minutes. Id. EMS took her to Duplin General ED, where she had a second seizure. Id. This
time, she was incontinent of urine. Id. Her seizures lasted for over 32 minutes. Id. Her left arm
where she received the hepatitis A injection was sore. Id. Family history shows that C.K.G.’s
sister has positional orthostatic tachycardia syndrome (“POTS”), and her brother has an atrial
flutter. Id. at 9. C.K.G.’s temperature was 99 degrees. Id. Her white blood count was elevated
at 16.4. Id. She had a history of seizing when she was dehydrated. Id. at 10.
On August 20, 2010, Dr. Burch, C.K.G.’s neurologist, wrote that C.K.G. had a history of
seizures at age five, possibly secondary to morphine. Id. at 19. She had an episode of status
epilepticus lasting 30 minutes. Id. She had a history of complicated migraines and had a mild
delay with speech articulation. Id. C.K.G. had abnormal EEGs in the past with slowing of the
4
left hemisphere. Id. She had a history of strabismus (when the eyes do not line up in the same
direction). Id. She had a history of complicated migraine vs. partial seizure two years earlier in
2008. Id. at 20. She had delay and hypotonia. Id. Her temperature was 99.5 degrees, but over
72 hours, she had a maximum temperature of 102.2 degrees and a minimum of 99 degrees, with
an average temperature of 100.2 degrees. Id.
On August 20, 2010, Dr. Gallo noted that C.K.G.’s mucus plug was suctioned. Id. at 33.
An MRI of C.K.G.’s brain on August 20, 2010 was normal. Id. at 34. Dr. Gallo stated
the next day that infection seemed unlikely given C.K.G.’s clinical status. Id. at 37. However,
given the risk of fever and aspiration during her seizure and postictal periods, C.K.G. would be
administered a second dose of Ceftriazone that day. Id. at 37. When C.K.G. was sent home, she
was prescribed Augmentin for five days in order to complete a seven-day course of antibiotics.
Id.
On August 21, 2010, Dr. Lilan Dusabe-Ziherambere, a pediatrician, noted that C.K.G.
was extubated at 12:15 p.m. on August 20, 2010. Id. at 13. Just prior to her extubation, C.K.G.
had fever and thick secretions. Id. Therefore, trachial aspirate and blood cultures were obtained,
and C.K.G. was started on an antibiotic, Rocephin. Id. C.K.G.’s trachial aspirate grew out
oropharyngeal flora. Id. at 18.
On August 22, 2010, C.K.G. was discharged from the hospital with a diagnosis of status
epilepticus and fever from an unclear source. Id. at 17. She was prescribed Keppra, Diastat for
seizures, and folic acid due to her MTHFR. Id.
On September 15, 2012, two years later, C.K.G. was brought to Vidant Medical Center
with altered mental status, right-sided weakness, slurred speech, and confusion. Id. at 173. Her
mother reported this began like previous events at 2:00 p.m. Id. C.K.G. presented at Onslow ED
with her right hand clenched and painful. Id. She had lethargy and malaise. Id. at 173–74. Her
temperature was 97.3 degrees. Id. at 174. Dr. Inga S. Aikman saw her that day and said C.K.G.
was taking Topomax and Trileptal. Id. at 176. C.K.G.’s seizures began on September 14, 2012,
when she complained of seeing a white light and then developed pain and clenching of her right
hand. Id. Later that night, she was found confused and unable to talk or walk. Id. Her parents
reported that she had similar episodes within the past year, marked by pain in her right hand,
which traveled to the right side of her face. Id. She had these episodes every six months. Id.
The most recent spell was at the beginning of the month. Id. She had several brain MRIs, which
were normal. Id. She had a history of gross motor delay and did not walk until she was 16
months of age. Id. The differential diagnosis was that she was most likely having a complex
migraine, but Dr. Aikman noted pseudoseizure2 should also be considered. Id. at 179.
2
Pseudoseizure is “an attack resembling an epileptic seizure but being a type of conversion disorder; it
lacks the electroencephalographic characteristics of epilepsy and the patient may be able to stop it by an
act of will.” Dorland’s Illustrated Medical Dictionary 1546 (32d ed. 2012). Conversion disorder is “a
5
On September 15, 2012, C.K.G. saw Dr. Burch, her neurologist, who noted a one-day
history of headache, fever, altered mental status, and questionable weakness on her right side.
Id. at 188. The weakness was questionable because, on examination, C.K.G. had no weakness,
sensory deficits, or cranial nerve deficits. Id. C.K.G. spoke in one-word answers and called Dr.
Burch “C.K.G.” Id. That week C.K.G. struggled with her accelerated math program with
tutoring and had difficulty sleeping because of it. Id. “It should be noted her sister years ago
was admitted for pseudoseizures after being in an accelerated math program.” Id. The
differential diagnosis was seizure, complicated/confusional migraine, encephalitis, or functional
cause (no physiologic basis). Id. Family history showed C.K.G.’s brother had hypotonia, and
her sister had pseudoseizures. Id. at 189.
Dr. Burch performed an EEG on C.K.G. on September 15, 2012, which was abnormal.
Id. at 203. C.K.G. had asymmetric background with slowing of the left hemisphere. Id.
For the sake of brevity, the undersigned omits a number of additional records and
summarizes a recent record from Duke Medicine, dated July 15, 2013. Med. recs. Ex. 4, at 6–7.
Nurse Practitioner Lyndsey Nicole Prange noted C.K.G.’s history of probable hemiplegic
migraines with recurrent headaches. Id. She had three episodes of right hemiplegia in 2008,
2011, and recently. Id. The last episode required hospitalization at Duke on March 28, 2012,
and was accompanied by aphasia. Id. C.K.G. had a history of generalized tonic-clonic status
epilepticus, the first episode occurring in June 2006, the second episode in “September3” 2010
after an immunization, and the third episode (a complex partial seizure) occurring on March 30,
2013, including loss of consciousness, left nystagmus, and foaming at the mouth. Id. C.K.G.’s
MTHFR mutation required use of folic acid. Id. She had an abnormal anticardiolipin antibody
and von Willibrand titers. Id. C.K.G. had vitamin D deficiency and mitochondrial DNA whole
gene sequencing, 2 VUS (variant of unknown significance). Id.
DISCUSSION
The first issue in this case is whether C.K.G.’s condition after her vaccination was
substantially worse than her condition before vaccination. Before vaccination, C.K.G. had gross
motor delay, speech dysfunction, complicated migraine headaches, seizures, and abnormal
mental disorder characterized by conversion symptoms (loss or alteration of voluntary motor or sensory
functioning suggesting physical illness, such as seizures, paralysis, dyskinesia, anesthesia, blindness, or
aphonia) having no demonstrable physiological basis and whose psychological basis is suggested by (1)
exacerbation of symptoms at times of psychological stress, (2) relief from tension or inner conflicts
(primary gain) provided by the symptoms, or (3) secondary gains (support, attention, avoidance of
unpleasant responsibilities) provided by the symptoms.” Id. at 549. “Symptoms are neither intentionally
produced nor feigned. . . .” Id.
3
This should be August 2010.
6
EEGs. After vaccination, C.K.G. had seizures and migraine headaches. The second issue,
assuming there was substantial deterioration, is whether the vaccine was the causal factor.
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. Sec’y of HHS, 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 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.
Petitioners must show not only that but for hepatitis A vaccination, C.K.G. would not
have had a seizure and migraines, but also that the vaccine was a substantial factor in causing her
seizure and migraines. Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999).
Although petitioners allege that hepatitis A vaccination exacerbated C.K.G.’s seizure
disorder and migraines, the medical records do not prove she had worsening of her seizure
disorder or migraines. Petitioners did not file a medical expert report in support of their
allegations. The undersigned gave petitioners 225 days, over seven months, to find an expert.
They did not find one. The Vaccine Act does not permit the undersigned to rule for petitioners
based on their claims alone, “unsubstantiated by medical records or by medical opinion.” 42
U.S.C. § 300aa-13(a)(1).
Thus, petitioners have not made a prima facie case of causation.
The undersigned GRANTS petitioners’ motion for a ruling on the record and
DISMISSES this case for petitioners’ failure to prove the allegations in their petition by a
preponderance of the evidence. 42 U.S.C. § 300aa-13(a)(1)(A).
7
CONCLUSION
This 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.4
IT IS SO ORDERED.
January 20, 2015 s/Laura D. Millman
DATE Laura D. Millman
Special Master
4
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.
8