Tomlinson v. Secretary of Health and Human Services

REISSUED FOR PUBLICATION
MAY 28, 2019
OSM
U.S. COURT OF FEDERAL CLAIMS
Jfn tbe mlniteb ~tates Id. at 13.
A. Procedural History
Petitioner initially filed the claim under his name only. I order the case caption be
corrected to reflect that the claim was filed on behalf of his minor child, C.T. On April 11, 2019,
1
Pursuant to the E-Govemment Act of 2002, see 44 U.S.C. § 3501 note (2012), because this decision contains a
reasoned explanation for the action in this case, I intend to post it on the website of the United States Court of
Federal Claims. The court's website is at ht-ip://www.uscfc.uscourts.gov/aggregator/sources/7. Before the decision
is posted on the court's website, each party has 14 days to file a motion requesting redaction "of any information
furnished by that party: (I) that is a trade secret or commercial or financial in substance and is privileged or
confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy." Vaccine Rule 18(b). "An objecting party must provide the court with a proposed
redacted version of the decision." Id If neither party files a motion for redaction within 14 days, the decision
will be posted on the court's website without any changes. Id
2 The Program comprises Pait 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-10 et.
seq. (hereinafter "Vaccine Act" or 'Id. at 14. C.T. was discharged to home with
her mother on December 20, 2013. Id. at 16. The next medical record included with the petition
was from January 3, 2019. Pet. Tab 3. The medical records reveal that C.T. experienced a five-
minute seizure, observed by her parents. Pet. Tab 3 at 40. She was taken by ambulance to
Carolina East Emergency Department. Id. C.T. was subsequently intubated with rapid sequence
sedation upon arrival at the hospital. Pet. Tab 3 at 26. C.T. was diagnosed with seizure and
status epilepticus and transferred to the Pediatric ICU at Vidant Medical Center the same day.
Pet. Tab 4 at 37. While in the hospital, C.T. underwent an MRI that showed minimal diffuse
FLAIR hyperintensity in the right mesial temporal lobe. Pet. Tab 4 at 47. C.T's father described
C.T. having a possible absence seizure about two years prior, when she was
"unresponsive ... .with eyes open for about 20 minutes," but medical care was not sought. Pet.
Tab 4 at 40. C.T. was discharged on January 6, 2019 with 5 mg of Diastat to be used as needed
in case of future seizures. Id. at 39.
The next medical record is from a paramedic report on February 6, 2019, where C.T. may
have been experiencing another seizure. Pet. Tab 3 at 32. C.T. 'smother called paramedics after
she thought C.T. was having another seizure. Id. C.T. was seen by Radonna Carroll, FNP-C., on
February 27, 2019. Pet. Tab 5 at 59. During this visit, it was noted that C.T. had never received
any health care or preventative medical services since birth. Id. at 61.
During the status conference, Mr. Tomlinson advised that he and his wife tried to analyze
what could have caused C.T,'s seizures. He explained that she had not received any other
medical care after birth and she did not have any significant illnesses. Further, he explained that
his other two children did not have seizures and they have not received any vaccines. Thus, he
and his wife concluded that hepatitis B vaccine administered to C. T. shortly after birth was the
cause of her seizures, as they could not identify any other cause.
I discussed that neurological disorders are extremely complex and seizure disorders are
not fully understood. I explained that sometimes seizure disorders have a genetic basis. For
3 A list of attorneys who have expressed a willingness to accept vaccine injury cases and is offered as a convenient
reference to pro se petitioners and potential petitioners in the program can be accessed:
h1tp://w,v,v.cofc.uscou11s.gov/vacc inc-progrnmoflice-spccial-rnasters.
2
example, a neurologist may look to whether an individual has a mutation such as in the SCN 1A
gene. According to the National Institute of Health Genetics Home Reference, "Hundreds of
mutations in the SCNlA gene have been found to cause genetic epilepsy with febrile seizures
plus (GEFS+), which is a spectrum of seizure disorders of varying severity. These conditions
include simple febrile (fever-associated seizures, which start in infancy and usually stop by age
5, and febrile seizures plus (FS+), including those not related to fevers (afebrile seizures)."4
Respondent's counsel stated that Dravet syndrome, a seizure disorder that often begins at
infancy, is associated with a mutation of the SCN 1A gene. I indicated that while the SCN 1A
gene mutation is better known, other types of seizure disorders, may have genetic components
that are not well understood.
I observed that the medical records included a note describing a "seizure disorder in
maternal great grandmother and maternal aunt." Pet. Tab 3 at 44 . The limited medical records
do not indicate if C.T. bad a genetic test for a possible gene mutation. While some seizure
disorders have a genetic basis, such as Dravet syndrome, others do not, and the field of
neurology continues to evolve and seeks to find more answers. Because the causes of seizure
disorders are not well understood and can be quite complex, vaccine cases involving seizure
disorders often involve extensive disagreements between medical experts analyzing the cases.
Then I explained that a petitioner has the burden of proof to establish that the vaccine was
the cause of the alleged injury. For a petitioner to prevail, there must be sufficient record that
consists of either medical records or the opinion of a competent physician, and in most cases,
both are necessary. Further, a Special Master cannot award compensation based solely on the
petitioner's claims. I explained that the limited medical evidence in this case would make it
extremely hard for petitioner to prevail. Further, the four-year period between when C.T.
received the Hepatitis B vaccine and the onset of seizure (even if at the earlier date described by
C.T. 's father) makes it extremely difficult for petitioner to prove there is a proximate temporal
relationship between the vaccination and the injury (Althen prong three).
B. Legal Standard and Dismissing the Petition
In order to prevail, a petitioner must prove either a "Table" injury or that a vaccine listed
on the Table was the cause-in-fact of an injury. § 11 (c )( l )(C). The Table identifies the vaccines
covered under the program, the corresponding injuries, and the time period in which the
particular injuries must occur after vaccination.5 42 U.S.C.§14(a).
An "off-Table" injury is initially shown when the petitioner demonstrates, by a
preponderance of the evidence: (1) that she received a vaccine set forth on the Vaccine Injury
Table; (2) that she received the vaccine in the United States; (3) that she sustained or had
significantly aggravated an illness, disease, disability, or condition caused by the vaccine; and (4)
that the condition has persisted for more than six months or that resulted in death.§ 13(a)(l)(A).
Petitioner must establish each of the three Althen factors by preponderant evidence: ( l) a medical
4
National Institute of Health, Genetics Home Reference, SCN lA-gene,
lmps:r/ghr.nlm.nih.g,ov/gcn1::/SCN I/\t/conditio11s (last accessed April 16, 2019).
5 The most recent version of the Table can be found at 42 C.F.R. §100.3.
3
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 proximate temporal
relationship between vaccination and injury. A/then v. Sec '.Y of Health & Human Servs., 418
F.3d 1274, 1278 (Fed. Cir. 2005).
Proving an "off-table," injury allows some flexibility in onset of injuries post-
vaccination, but petitioner bears the burden for showing a proximate temporal relationship. This
requires that the onset of symptoms occurred within a time frame for which, given the medical
understanding of the disorder's etiology, it is medically acceptable to infer causation-in-fact. De
Bazan v. Secy of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).
In the Omnibus Hepatitis B vaccine-demyelinating injury cases, a three to sixty-day time
frame between the hepatitis B vaccine and the onset of Guillain-Barre Syndrome ("GBS"),
transverse-myelitis ("TM"), multiple sclerosis ("MS") and chronic inflammatory demyelinating
polyneuropathy ("CIDP") has been found to be medically appropriate. See Pecore/la v. Sec '.Y of
Health & Human Servs., No. 04-1781, 2008 WL 4447607 (Fed. Cl. Spec. Mstr. Sept. 17, 2008);
See also Stevens v. Sec '.Y of Health & Human Servs., No. 99-594, 2006 WL 659585 (Fed. Cl.
Spec. Mstr. Feb. 24, 2006); Gilbert v. Secy of Health & Human Servs., No. 04-455V, 2006 WL
1006612 (Fed. Cl. Spec. Mstr. Mar. 30, 2006); Werderitsh v. Sec '.Y of Health & Human Servs ..
No. 99-3 l 0V, 2006 WL 1672884 (Fed. Cl. Spec. Mstr. May 26, 2006); and Peugh v. Secy of
Health and Human Servs., No. 99-638V, 2007 WL 153 1666 (Fed. Cl. Spec. Mstr. May 8, 2007).
But the medically accepted time frames established in the hepatitis B vaccine injury cases are the
upper bounds between vaccination and onset of symptoms. In Nussman, the Claims Court
upheld the Special Master's finding that a Hepatitis B vaccine given fo rty-one days prior to
petitioner's in ifoil seizure was outside the appropriate time frame for proving a proximFtte
temporal relationship. Nussman v. Secy of Health & Human Servs., 83 Fed. Cl. 111, 123 (Fed.
Cl. 2008). In the current case, the time elapsed between C.T. receiving the vaccine and her
recorded seizure is five years.
As discussed above, C.T. received the vaccination in question when she was born, on
December 17, 2013. Pet. Tab 2. The first symptom of seizures recorded in her medical records
was not until five years later, on January 3, 2019. While petitioner's father indicated to medical
professionals that C.T. may have suffered seizures two years before January 2019, there are no
corresponding medical records associated with his statements. See Pet. Tabs 4 & 5. Petitioner's
father told Dr. Hassan that a year before she was admitted to the hospital, C.T. had one-minute
episodes where her entire body would get stiff and it would appear as though she was clenching
her body. Pet. Tab 4 at 44. He stated that they would shake C .T. and she would snap out of it
and go to the bathroom to urinate. Id. The episodes lasted for four months and they did not seek
medical attention. Id
During the status conference I inquired whether petitioner had any additional medical
records or vaccination records that could be submitted that were closer in time to the onset of
C.T's symptoms. Petitioner stated that no other vaccines were administered, and no medical
records existed between the time of vaccine administration and C.T.' s hospitalization in January
2019. This is consistent with the statements made to medical professionals by petitioner that
appear in the medical records. See Pet. Tabs 2 through 3.
4
In the present case, petitioner does not allege a Table injury. Thus, to prevail on
entitlement, petitioner must establish that the Hepatitis B vaccine is the actual cause of C.T. 's
injuries. Under the Vaccine Act, a petitioner may not be awarded compensation based solely on
the petitioner's claims. Rather, the petition must be supported by either medical records or by
the opinion of a competent physician. §300aa-13(a)(l ).
Petitioner has not submitted medical records or other evidence sufficient to establish
entitlement to compensation, nor do additional medical records exist between C.T's discharge
from the hospital after birth and January 2019. Petitioner has not submitted the opinion of a
competent physician linking C.T. 's alleged injury to the Hepatitis B vaccine she received on
December 17, 2013. Even if the onset of C.T. 's seizures began at three, as the father thought
they may have, the Vaccine Program has yet to consider a case that has found vaccine causation
for a condition with onset even close to three years after vaccination.
Viewing the facts in the light most favorable to the petitioner I can see no plausible
avenue for proving any connection between the vaccine and the child's seizure disorder.
Therefore, in accordance with the reasoning stated above, the petition is DISMISSED
for insufficient proof. The Clerk of the Court shall enter judgement accordingly.6
IT IS SO ORDERED.
Thomas L. Gowen
Special Master
6
Entry of judgment is expedited by each party's fi ling notice renouncing the right to seek review. Vaccine Rule
1 l(a).
5