Kelly Arango, Parent Of, Isabela Orozco, a Minor v. Secretary of Health and Human Services

In the United States Court of Federal Claims
No. 09-318V
(Filed Under Seal: February 4, 2013)
(Reissued for Publication: February 22, 2013)
TO BE PUBLISHED
)
KELLY ARANGO, Parent of, ISABELA ) National Vaccine Injury Compensation
OROZCO, a Minor, ) Program; National Childhood Vaccine
) Injury Act of 1986, 42 U.S.C. §§ 300aa-1
Petitioner, ) to -34; DTaP Vaccine; Acute
) Encephalopathy; Seizures; 42 C.F.R.
v. ) § 100.3(b)(2)(i)(E).
)
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
David E. Marmelstein, David E. Marmelstein & Associates, Enfield, Conn., for
petitioner.
Ryan D. Pyles, Trial Attorney, Gabrielle M. Fielding, Assistant Director, Vincent J.
Matanoski, Acting Deputy Director, Rupa Bhattacharyya, Director, Torts Branch, Stuart F.
Delery, Acting Assistant Attorney General, Civil Division, U.S. Department of Justice,
Washington, D.C., for respondent.
OPINION AND ORDER1
GEORGE W. MILLER, Judge
Petitioner, Kelly Arango, on behalf of her daughter, Isabela Orozco, filed a motion for
review (docket entry 42, Sept. 20, 2012) of Special Master Sandra Lord’s August 23, 2012
decision (docket entry 40) denying compensation under the National Vaccine Injury
Compensation Program, 42 U.S.C. §§ 300aa-1 to -34, established by the National Childhood
Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (codified as amended at 42
U.S.C. §§ 300aa-1 to -34 (2006)) (the “Vaccine Act”). Petitioner filed for compensation on
May 11, 2009, alleging that Isabela was injured by the diphtheria, tetanus, and acellular pertussis
1
Pursuant to Rule 18(b), Appendix B of the Rules of the Court of Federal Claims, this Opinion
and Order was initially filed under seal. The parties were afforded fourteen days in which to
propose redactions. Neither party proposed any redactions. Accordingly, the Opinion and Order
is released in its entirety.
(“DTaP”); haemophilus influenza type B (“Hib”); inactivated poliovirus (“IPV”); Prevnar
(pneumococcal 7-valent conjugate); and rotavirus vaccines she received on March 8, 2008.
Special Master Lord held an entitlement hearing on March 25, 2011 in New York City. The
special master ruled that petitioner failed to prove a Table injury because Isabela only suffered
seizures, not an acute encephalopathy. As to causation-in-fact, the special master found
insufficient evidence of causation: merely a temporal relationship between Isabela’s vaccination
and her infantile spasms. Thus, the special master dismissed the petition.
Petitioner timely filed a motion for review under § 300aa-12(e) of the Vaccine Act. See
Pet’r’s Mot. for Review and Supp’g Mem. of Law (“Pet.”) (docket entry 42, Sept. 20, 2012).
Petitioner asserts that the special master’s decision should be vacated and the Court should
remand the case back to the special master for determination of appropriate compensation. Id.
at 14.
I. Background2
A. Isabela’s Medical History
Isabela Orozco was born on November 27, 2007. Arango, 2012 WL 4018028, at *2. On
November 29, 2007 and December 28, 2007, she received vaccinations without incident. Id. As
part of her four-month well-child check up, she received DTaP, Hib, IPV, Prevnar
(pneumococcal 7-valent conjugate), and rotavirus vaccines on March 28, 2008. Id.In the days following her March 28 vaccinations, Isabela began to experience symptoms
of what would eventually be diagnosed as infantile spasms. Id. at *2–4. Petitioner reported
these symptoms to Isabela’s pediatrician, Dr. Jennifer Henkind, in a April 3, 2008 phone call,
noting that “Isabela seems to ‘zone out’ and eyes roll to the side of her head, doesn’t turn her
head when mom talks to her, ‘snaps out of it’ a few minutes later. Has been doing this a few
times a day for the past few days.” Id. at *2. Isabela was brought to the pediatrician’s office on
April 3, and while there she again experienced “rhythmical shaking in all four extremities.” Id.
She was then taken to the Stamford Hospital Emergency Room and admitted to the hospital,
where she was treated by Dr. Philip Overby, a neurologist. Id. Isabela underwent a 24-hour
electroencephalogram (“EEG”) on April 23, 2008, and it revealed an electroclinical seizure, non-
localizable, and multifocal spikes and poly-spikes. Id. at *3.
Following a week in which Isabela experienced seizures lasting several seconds in
clusters of four to five minutes, Dr. Overby once again examined Isabela on May 5, 2008. Id.
An EEG revealed that Isabela was experiencing hypsarrhythmia, which is “characteristic of
infantile spasms.” Id. Isabela was prescribed the anti-epileptic medications Phenobarbital and
Keppra. Id. Dr. Overby noted that Isabela was most likely experiencing cryptogenic, rather than
symptomatic, infantile spasms. Id. She was admitted to the Montefiore Epilepsy Monitoring
2
The parties do not dispute the underlying facts of this case, which, for purposes of this Opinion
and Order, are taken from the special master’s decision, Arango v. Sec’y of Health & Human
Servs., No. 09-318V, 2012 WL 4018028 (Fed. Cl. Spec. Mstr. Aug. 23, 2012). For a detailed
recitation of the underlying facts, see id. at *3–16.
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Unit. Id. While there, Isabela was prescribed adrenocorticotropic hormone (“ACTH”), and on
May 12, 2008, she was discharged with a diagnosis of infantile spasms, hypsarrhythmia,
hypotonia, and developmental delay. Id. Dr. Overby noted on May 20, 2008 that Isabela was
partially responding to the ACTH treatment. Id. Over the next three months, Isabela’s condition
appeared to improve significantly. Id. Her seizures had ceased, and she regained previously lost
developmental milestones. Id. She received another Hib vaccine on July 8, 2008 without
experiencing any symptoms. Id.On August 28, 2008, however, she was given a hepatitis B vaccine, and shortly thereafter
her symptoms returned. Id. at *3–4. Petitioner phoned Dr. Henkind’s office on September 2,
2008 to report that Isabela appeared to have experienced a seizure. Id. at *3. Dr. Henkind’s
office noted that it would “hold all further vaccines until done with spasm treatment and has been
stable.” Id. (quoting Pet’r’s Ex. 4, at 93). On September 18, 2008, another EEG was performed
on Isabela, and it revealed “numerous abnormalities, including hypsarrhythmia.” 2012 WL
4018028, at *4. Dr. Overby restarted Isabela’s ACTH treatment and also prescribed Topamax,
another anti-convulsant medication. Id. Dr. Henkind noted during a September 24, 2008
appointment that Isabela’s seizures had returned “within 24 hours of last vaccine given.” Id.(quoting Pet’r’s Ex. 4, at 22).
Isabela’s diagnosis of infantile spasms remains unchanged, and her development has been
delayed. 2012 WL 4018028, at *4. She stopped taking Prednisone and Keppra, but her
Topamax has been increased, and in addition she has been prescribed Depakote, another anti-
epileptic medication. Id.II. Procedural History
Petitioner filed her petition on May 11, 2009 (docket entry 1). The petition claims that
Isabela’s injury satisfies the requirements both for an encephalopathy Table injury and that the
vaccine was the cause-in-fact of Isabela’s encephalopathy. 2012 WL 4018028, at *1.
Respondent subsequently filed a Vaccine Rule 4(c) report (docket entry 9, July 28, 2009);
petitioner filed an expert report from Dr. Overby (docket entry 16, May 27, 2010); respondent
filed an expert report from Dr. Mary Anne Guggenheim, a pediatric neurologist (docket entry 17,
Aug. 11, 2010); and petitioner filed a diagnostic report (docket entry 23, Feb. 18, 2011). Special
Master Lord held an entitlement hearing on March 25, 2011. Both parties filed post-hearing
briefs (docket entry 34, July 12, 2011; docket entry 36, Aug. 26, 2011). The special master
issued her Decision on August 23, 2012 finding that petitioner failed to establish either a Table
encephalopathy or causation-in-fact of an off-Table injury.
III. Jurisdiction and Standard of Review
Pursuant to the Vaccine Act, the Court of Federal Claims has jurisdiction to review
decisions of special masters. 42 U.S.C. § 300aa-12(e). The Court reviews the legal conclusions
of the special master de novo and defers to the special master on findings of fact, unless the
Court determines that such findings are arbitrary or capricious. Porter v. Sec’y of Health &
Human Servs., 663 F.3d 1242, 1248–49 (Fed. Cir. 2011); Broekelschen v. Sec’y of Health &
Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010). “‘[R]eversible error will be extremely
difficult to demonstrate’ where the special master ‘has considered the relevant evidence of
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record, drawn plausible inferences and articulated a rational basis for the decision.’” Porter, 663
F.3d at 1253–54 (quoting Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1528 (Fed.
Cir. 1991)).
IV. Discussion
Petitioner challenges only the special master’s holding that Isabela’s injury was not a
Table injury. Pet. 1–2. To establish a Table injury, petitioner must show that Isabela suffered an
“illness, disability, injury, or condition set forth in the Vaccine Injury Table . . . and the first
symptom or manifestation of such illness, disability, injury, or condition . . . occurred within the
time period after vaccine administration set forth in the Vaccine Injury Table.” 42 U.S.C.
§ 300aa-11(c)(1)(C)(i). The Vaccine Injury Table is found at 42 U.S.C. § 300aa-14(a) and 42
C.F.R. § 100.3(a).3 In this case, petitioner alleges that Isabela suffered an encephalopathy.
Pet. 1–2. Of the vaccines Isabela received on March 28, 2008, only the DTaP vaccine is
associated in the Vaccine Injury Table with an encephalopathy. 42 C.F.R. § 100.3(a)(II). The
time period for manifestation of an encephalopathy is seventy-two hours after administration of
the DTaP vaccine. Id.A Table “encephalopathy” is defined as “any significant acquired abnormality of, or
injury to, or impairment of function of the brain.” § 300aa-14(b)(3)(A). The Secretary of Health
and Human Services’ Qualifications and Aids to Interpretation (“QAI”) further limit an
encephalopathy to cases in which the vaccine “recipient manifests, within the applicable period,
an . . . acute encephalopathy, and then a chronic encephalopathy persists in such person for more
than 6 months beyond the date of vaccination.” § 100.3(b)(2).
An acute encephalopathy is defined as “one that is sufficiently severe so as to require
hospitalization (whether or not hospitalization occurred).” § 100.3(b)(2)(i). In particular:
For children less than 18 months of age who present without an associated seizure
event, an acute encephalopathy is indicated by a significantly decreased level of
consciousness lasting for at least 24 hours. Those children less than 18 months of
age who present following a seizure shall be viewed as having an acute
encephalopathy if their significantly decreased level of consciousness persists
beyond 24 hours and cannot be attributed to a postictal state (seizure) or
medication.
§ 100.3(b)(2)(i)(A). Section 100.3(b)(2)(i)(D) of the QAI further states that a “significantly
decreased level of consciousness” is indicated by “the presence of at least one of the following
clinical signs for at least 24 hours or greater”:
(1) Decreased or absent response to environment (responds, if at all, only to loud
voice or painful stimuli);
3
The statute permits regulations promulgated by the Secretary of Health and Human Services to
modify the statutory version of the Table. 42 U.S.C. § 300aa-14(c)(1).
4
(2) Decreased or absent eye contact (does not fix gaze upon family members or
other individuals); or
(3) Inconsistent or absent responses to external stimuli (does not recognize
familiar people or things).
The QAI also sets forth symptoms that the Table considers insufficient to prove an acute
encephalopathy:
The following clinical features alone, or in combination, do not demonstrate an
acute encephalopathy or a significant change in either mental status or level of
consciousness as described above: Sleepiness, irritability (fussiness), high-pitched
and unusual screaming, persistent inconsolable crying, and bulging fontanelle.
Seizures in themselves are not sufficient to constitute a diagnosis of
encephalopathy. In the absence of other evidence of an acute encephalopathy,
seizures shall not be viewed as the first symptom or manifestation of the onset of
an acute encephalopathy.
§ 100.3(b)(2)(i)(E) (emphasis added).
The special master found that, because Isabela’s only symptoms were seizures, petitioner
failed to prove that Isabela suffered an acute encephalopathy within seventy-two hours of her
DTaP vaccine. 2012 WL 4018028, at *14 (“Isabela did not suffer an acute encephalopathy in the
72 hours following her vaccination; she suffered seizures.”). The special master found that it
was not enough that within seventy-two hours of the vaccination something happened which led
to Isabel’s chronic encephalopathy. Id. at *15. Rather, the Table requirement is that an acute
encephalopathy must occur within seventy-two hours of the vaccine. Id. Since Isabela never
experienced symptoms sufficient to prove an acute encephalopathy, the special master found that
she had not suffered a Table encephalopathy. Id. at *14–15.
Petitioner argues that the special master erred by finding that Isabela’s seizures within
seventy-two hours of her DTaP vaccine did not constitute an acute encephalopathy. First,
petitioner cites Dr. Henkind’s testimony that she would have admitted Isabela to the hospital if
she had been aware of the symptoms that Isabela experienced in the seventy-two hours after her
vaccine (March 28 through April 1, 2008). Pet. 10 (quoting Hr’g Tr. 29:16–30:6 (docket entry
31, April 28, 2011)). Petitioner seems to argue that this testimony is sufficient to satisfy
§ 100.3(b)(2)(i). See Pet. 3 (quoting § 100.3(b)(2)(i)(A) (defining an acute encephalopathy as
“one that is sufficiently severe so as to require hospitalization (whether or not hospitalization
occurred)”)). Second, petitioner argues that the actual cause of Isabela’s injury is unknown. Pet.
10–12. The Court understands petitioner to be arguing that, if the actual cause of the injury is
unknown, it should be considered a Table injury. See Pet. 3 (quoting § 100.3(b)(2)(iii) (“If at the
time a decision is made on a petition filed under section 2111(b) of the Act for a vaccine-related
injury or death, it is not possible to determine the cause by a preponderance of the evidence of an
encephalopathy, the encephalopathy shall be considered to be a condition set forth in the
Table.”)). Neither of petitioner’s two arguments is reason to reverse the special master’s
decision.
5
Petitioner’s first argument, based on § 100.3(b)(2)(i), ignores the exception contained in
§ 100.3(b)(2)(i)(E). It is true that § 100.3(b)(2)(i) defines an acute encephalopathy as an
encephalopathy that is severe enough to require hospitalization. The QAI requires, however,
additional evidence other than seizures. § 100.3(b)(2)(i)(E) (“Seizures in themselves are not
sufficient to constitute a diagnosis of encephalopathy. In the absence of other evidence of an
acute encephalopathy, seizures shall not be viewed as the first symptom or manifestation of the
onset of an acute encephalopathy.”). Petitioner does not dispute, however, that Isabela’s
symptoms were seizures. Therefore, the special master correctly determined that Isabela’s
symptoms were insufficient to establish an acute encephalopathy.
Petitioner’s second argument—that the actual cause of Isabela’s injury is unknown—
relies on an incorrect reading of § 100.3(b)(2)(iii), which does not govern how a petitioner may
prove an encephalopathy. Rather, that regulation governs how a respondent may rebut a
petitioner’s proof of an encephalopathy. See Nilson v. Sec’y of Health & Human Servs., 69 Fed.
Cl. 678, 682–83 (2006). Given that the special master correctly determined that Isabela’s
seizures did not constitute an acute encephalopathy, the special master did not consider the
question of whether respondent had proved a non-vaccine cause of Isabela’s injury. See Argueta
v. Sec’y of Health & Human Servs., No. 07-784V, 2011 WL 2945803, at *2 n.5 (Fed. Cl. Spec.
Mstr. June 30, 2011). Thus, § 100.3(b)(2)(iii) is irrelevant to petitioner’s Table injury claim and
therefore does not excuse petitioner from the requirement of proving that Isabela’s injury
satisfied the QAI requirements for an acute encephalopathy.
CONCLUSION
In view of the foregoing, the Court upholds the special master’s findings of fact and
conclusions of law as well as the special master’s decision denying petitioner’s claim for
compensation under the Vaccine Act. Accordingly, petitioner’s motion for review is DENIED
and Special Master Lord’s August 8, 2012 decision is AFFIRMED.
IT IS SO ORDERED.
s/ George W. Miller
GEORGE W. MILLER
Judge
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