Espirito Santo v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: August 31, 2022
* * * * * * * * * * * * * * * * * *
CAMILA DO ESPIRITO SANTO, * No. 18-1725v
*
Petitioner, * Special Master Sanders
*
v. *
*
SECRETARY OF HEALTH * Ruling on the Record; Entitlement Decision;
AND HUMAN SERVICES, * Influenza (“Flu”) Vaccine; Measles Mumps
* Rubella (“MMR”) Vaccine; Preeclampsia;
Respondent. * Missed Abortion
* * * * * * * * * * * * * * * * * *
John F. McHugh, Law Office of John McHugh, New York, N.Y., for Petitioner
Lynn C. Schlie, United States Department of Justice, Washington, D.C., for Respondent
DECISION ON ENTITLEMENT 1
On November 5, 2018, Camila Do Espirito Santo (“Petitioner”) filed a petition pursuant to
the National Vaccine Injury Compensation Program (“Program” or “Vaccine Program”). 2
Petitioner alleges that she received the measles mumps rubella (“MMR”) and influenza (“flu”)
vaccinations on October 15, 2016, and that these vaccines resulted in “injuries affecting the health
of her fertility, such as [the] death of [her] in utero child (missed abortion), and subsequent severe
preeclampsia.” 3 Pet. at 1, ECF No. 1.
Respondent filed a motion for a ruling on the record dismissing Petitioner’s claim on
August 30, 2021. Resp’t’s Mot., ECF No. 57. Petitioner filed a response on December 9, 2021.
Pet’r’s Resp., ECF No. 61. Respondent did not file a reply. This matter is now ripe for
1
This Decision shall be posted on the United States Court of Federal Claims’ website, in accordance with
the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of
Electronic Government Services). This means the Decision will be available to anyone with access to
the Internet. In accordance with Vaccine Rule 18(b), a party has 14 days to identify and move to redact
medical or other information that satisfies the criteria in § 300aa-12(d)(4)(B). Further, consistent with the
rule requirement, a motion for redaction must include a proposed redacted Decision. If, upon review, I agree
that the identified material fits within the requirements of that provision, such material will be withheld
from public access.
2
National Childhood Vaccine Injury Act of 1986, Pub.L. No. 99–660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa
(2012).
3
Preeclampsia is “a complication of pregnancy characterized by hypertension, edema, and/or proteinuria;
when convulsions and coma are associated[.]” Dorland’s Illustrated Medical Dictionary 1, 1509 (32nd ed.
2012) [hereinafter “Dorland’s”].
consideration. For the reasons stated below, I GRANT Respondent’s motion and Petitioner’s case
is hereby DISMISSED.
I. Procedural History
Petitioner filed her petition for compensation, pro se, on November 5, 2018. See Pet. On
that date, Petitioner also filed her green card documentation and several medical records. Pet’r’s
Exs. 1–10, ECF Nos. 1-3–1-12. Petitioner filed additional medical records and a statement of
completion on December 26, 2018. Pet’r’s Ex. 12, ECF Nos. 9–10. On February 21, 2019,
Petitioner filed additional medical records, medical literature, and two affidavits. Pet’r’s Exs. 18,
40, 69–131, 133, ECF Nos. 11-1–11-68.
The same day, Petitioner filed a motion to change the case caption to include an action “on
behalf of her unborn child.” ECF No. 13. On March 11, 2019, Respondent filed his response to
Petitioner's motion. Resp't's Resp., ECF No. 15. On March 18, 2019, Petitioner submitted a reply
to Respondent's response. Pet'r's Reply, ECF No. 16. I denied Petitioner’s motion on July 25, 2019,
and found Petitioner “may not assert more than one claim per petition . . . [or] on behalf of a
petitioner who was not born alive.” Order at 3, ECF No. 18. Instead, I noted Petitioner must assert
one claim on her behalf for her miscarriage and subsequent severe preeclampsia and one claim on
behalf of any child born alive for his or her injury. Id.
Respondent noted in a status report filed on August 26, 2019, that several medical records
were missing, including Petitioner’s pre-vaccination records. ECF No. 20. Petitioner filed
additional records on September 26, 2019, and a statement of completion. Pet’r’s Exs. 135–137,
ECF Nos. 22–23. Petitioner filed a motion to issue a subpoena for outstanding medical records on
December 2, 2019, which I granted on December 5, 2019. ECF Nos. 27, 29.
Respondent then filed his Rule 4(c) report on December 30, 2019. Resp’t’s Report, ECF
No. 30. In his report, Respondent stated that Petitioner has not “provided a medical expert report
in support of her claim,” and her claim should be denied. Id. at 1. Petitioner responded to
Respondent’s report on February 3, 2020, with a status report regarding her submitted evidence,
including “vaccine injury compensation data,” and medical literature. Pet’r’s Exs. 142–148, ECF
Nos. 32-1–32-7.
On July 24, 2020, I ordered Petitioner to file an expert report by no later than September
21, 2020. ECF No. 35. I extended the deadline on several occasions through November 23, 2020.
See ECF Nos. 37, 40, 42. On November 13, 2020, Petitioner filed a motion to substitute counsel.
ECF No. 43. I granted the motion, and Mr. Howard Gold began his representation of Petitioner on
November 19, 2020. ECF No. 44. On November 19, 2020, Petitioner requested an additional
extension of time, until January 22, 2021, to obtain and file an expert report. ECF No. 46. After a
fifth extension of time, Petitioner filed her expert report from Dr. Leslie Hansen Lindner on March
12, 2021, along with a status report. Pet’r’s Ex. A, ECF Nos. 48–49. After a review of Petitioner’s
expert report, I scheduled a status conference with the parties that was held on March 18, 2021.
Min. Entry, docketed Mar. 18, 2021. During the conference, Petitioner’s counsel indicated his
intention to withdraw from the claim. See ECF No. 50. On March 28, 2021, Petitioner filed a
motion for attorneys’ fees on behalf of Mr. Gold indicating that he had withdrawn from the case
2
because it “became clear to [c]ounsel that upon the filing of the expert report from Dr. Hansen
Lindner that reasonable basis to continue with this claim would no longer exist.” Pet’r’s Mot. at 2,
ECF No. 51. On May 4, 2021, Mr. John McHugh substituted in as counsel for Petitioner. ECF No.
54. I awarded Petitioner a final opportunity, until June 21, 2021, to obtain and file an expert report
in compliance with my July 24, 2020 Order. ECF No. 55. On June 21, 2021, Petitioner filed a
status report wherein she acknowledged that the expert report she filed on March 12, 2021, was
inadequate. ECF No. 56 at 1. She further stated that she had “been unable to locate an expert in
the field in the time allotted,” and she is “determined to proceed with the same expert[]” and her
claim as it is. Id. at 1, 6. Petitioner’s status report included references to parts of medical literature
articles that were not filed in total for the record. See id.
In response to Petitioner’s status report, Respondent filed a motion for a ruling on the
record on August 30, 2021. Resp’t’s Mot., ECF No. 57. In her first motion for an extension of time
to respond to Respondent’s motion, Petitioner noted her initial belief “that no basis existed to
respond.” Pet’r’s Mot., ECF No. 58. Nevertheless, she sought time “to resolve some matters with
her expert.” Id. She also noted that her June status report “list[ed] significant support for the
concept that the flu vaccination, i.e.[,] H1N1, has been suspect in miscarriages for some time and
the [sic] all flu vaccines have many of the same issues.” Id. On October 14, 2021, Petitioner filed
a second motion for an extension of time and explained that “[i]t turns out that the expert report
filed in this matter by the prior attorney was not authorized to be submitted.” Pet’r’s Mot., ECF
No. 59. She acknowledged that “[t]he question of reasonable cause prohibits [her counsel’s] office
from retaining experts as the chance of losing the investment is high.” Id. at 2. However, Petitioner
indicated a desire to continue with her claim and requested “two months to see if she can find
expert help.” Id. Petitioner filed her response to Respondent’s motion for a ruling on the record on
December 9, 2021. Pet’r’s Resp., ECF No. 61. Petitioner also filed a motion for attorneys’ fees on
behalf of Mr. John McHugh on April 22, 2022. ECF No. 62. Respondent responded to Petitioner’s
motion for fees on April 26, 2022. ECF No. 63. Respondent did not file a reply to Petitioner’s
response to his motion for a ruling on the record. This matter is now ripe for consideration.
II. Evidence
a. Medical Records
Petitioner’s medical history pre vaccination is significant for migraines and
hypogammaglobulinemia. 4 Pet’r’s Ex. 115 at 4, ECF No. 11-51; Pet’r’s Ex. 102 at 14, ECF No.
11-38. Included in Petitioner’s medical record is a letter from Petitioner’s treating physician, Dr.
Halfoun, during Petitioner’s residence in Brazil from 2012 to 2015. Pet’r’s Ex. 135, ECF No. 22-
1. Dr. Halfoun noted to the best of her knowledge, Petitioner was in “good physical and mental
health with no history of abortions, whether missed or induced.” Id. On March 25, 2016, she was
seen at the Stanford Health Care Emergency Department with complaints of abdominal pain and
cramping, dysuria,5 and hematuria.6 Pet’r’s Ex. 69 at 1–3, ECF No. 11-3. She was diagnosed with
a potential UTI and a yeast infection. Id. Petitioner was seen again on May 15, 2016, for similar
4
Hypogammaglobulinemia refers to “abnormally low levels of all classes of immunoglobulins in the
blood[.]” Dorland’s at 901.
5
Dysuria is “1. painful urination. 2. any difficulty of urination.” Dorland’s at 585.
6
Hematuria refers to “blood (erythrocytes) in the urine[.]” Dorland’s at 834.
3
symptoms, including blood in the urine and stool, abdominal cramping, migraines, dizziness, and
nausea. Pet’r’s Ex. 71 at 1–2, ECF No. 11-5. She was diagnosed with a UTI and gastroenteritis. 7
Id.
On October 15, 2016, Petitioner was seen at the FCHC – Foothill Family Clinic for a
tuberculosis (“TB”) test and vaccinations for her immigration forms. Pet’r’s Ex. 74 at 1, ECF No.
11-8. Petitioner denied that she was experiencing any changes to her menstrual cycle or that she
could be pregnant. Id. Her medical records indicate that a urine pregnancy test administered during
that visit was negative. Pet’r’s Ex. 3 at 1, ECF No. 1-5; Pet’r’s Ex. 74 at 2. Petitioner received a
flu vaccine and an MMR vaccine that day. Pet’r’s Ex. 75 at 2, ECF No. 11-9; Pet’r’s Ex. 76 at 1,
ECF No. 11-10.
On October 17, 2016, Petitioner returned to the Foothill Family Clinic for her TB test
reading. Pet’r’s Ex. 79 at 1–2, ECF No. 11-13. Her TB test revealed a positive purified protein
derivative (“PPD”). Pet’r’s Ex. 12 at 4 (also marked “#60”), ECF No. 10; Pet’r’s Ex. 78 at 1, ECF
No. 11-12. Petitioner was seen again at Foothill Family Clinic on October 21, 2016. Pet’r’s Ex. 4
at 1, ECF No. 1-6. Her records indicate a positive pregnancy test with an estimated due date of
June 6, 2017. Id. Her human chorionic gonadotropin (“HCG”) 8 level of 267 was consistent with
one to two weeks gestation, and she was referred to an OB/GYN. Pet’r’s Ex. 84 at 2, ECF No. 11-
18. Ten days later, on October 31, 2016, Petitioner’s HCG level was 6,971, which is consistent
with approximately three to four weeks gestation. Pet’r’s Ex. 85 at 1, ECF No. 11-19. On
November 6, 2016, Petitioner reported to the Santa Clara Medical Center Emergency Department
with complaints of a small amount of vaginal bleeding lasting three days and one day of
intermittent lower abdominal pain. Pet’r’s Ex. 86 at 1, 26, ECF No. 11-20. The records from Santa
Clara on this date note her gestation at seven weeks. Id. at 1.
The same day, Petitioner was referred for a gynecology consult for a “pregnancy of
unknown location,” and the recorded history noted that Petitioner had “pelvic cramping for a
couple of weeks . . . [s]ince [the] bleeding started the pelvic cramping has changed in character
and feels more like a ‘heavy internal pain.’” Id. at 3. A physical exam revealed a small amount of
old blood and a closed cervix with no active bleeding. Id. at 5. Petitioner’s HCG level was 10,732,
indicating approximately five to six weeks gestation. Id. at 5–6, 9. A pelvic ultrasound showed a
“1.3 cm sac like structure without [a] yolk sac or fetal pole . . . there [wa]s surrounding decidual
reaction[.]” Id. at 6. Based on the ultrasound, the attending physician noted that an “ectopic
pregnancy cannot be excluded.” Id. at 6, 15. The attending physician noted that the impression was
likely a missed abortion, “given [Petitioner’s] elevated BHCG beyond discriminatory zone,
timeline, elevation of BHCG, and no identifiable [intrauterine pregnancy].” Id. at 6. The physician
7
Gastroenteritis is “inflammation of the lining of the stomach and intestines, characterized by anorexia,
nausea, diarrhea, abdominal pain, and weakness. Causes include food poisoning . . . ; viral infections . . . ;
consumption of irritating food or drink; and sometimes psychological factors such as anger, stress, or fear.”
Dorland’s at 764.
8
Human chorionic gonadotropin (“HCG”) or beta-human chorionic gonadotropin (“BHCG”) is “a two-
subunit glycopeptide hormone produced by syncytiotrophoblasts of the fetal placenta that maintains the
function of the corpus luteum during the first few weeks of pregnancy, and is thought to promote
steroidogenesis in the fetoplacental unit and to stimulate fetal testicular secretion of testosterone.”
Dorland’s at 797.
4
continued, “[a]lthough [Petitioner had a] cystic structure within [the] endometrial canal [and] most
likely [an] empty gestational sac, [we] cannot rule out early possible multiple gestation leading to
[a] more elevated BHCG.” Id. Petitioner was discharged on November 7, 2016, with final
diagnoses including “[a]bdominal pain affecting pregnancy; [t]hreatened abortion; and
[p]regnancy of unknown anatomic location.” Pet’r’s Ex. 5 at 1, ECF No. 1-7.
On November 15, 2016, Petitioner underwent another ultrasound, which revealed an
“intrauterine cystic structure without [a] yolk sac or embryonic pole.” Id. at 2; Pet’r’s Ex. 89 at 1,
ECF No. 11-23. The impression was a possible failed pregnancy. Pet’r’s Ex. 87 at 2, ECF No. 11-
21. She was asked to return in one week for a final ultrasound. Id. The physician also noted that
Petitioner was reassured “[regarding] her prior MMR [vaccination]. There is no known actual risk
of this in pregnancy, though it is not recommended to be given routinely as a matter of caution.”
Id.
The next day, Petitioner presented to Santa Clara Valley Obstetrics. Pet’r’s Ex. 89 at 10.
The physician noted that Petitioner likely had a “failed pregnancy although [a] pseudo sac (ectopic
pregnancy) cannot be ruled out . . . correlated with [dilation and curettage (“D&C”)] path to
confirm [her] missed abortion.” Id. at 1. The impression was a missed abortion at ten weeks based
upon the date of her last period. Id. at 11. On November 23, 2016, Petitioner underwent a vacuum
aspiration. Pet’r’s Ex. 8 at 1, ECF No. 1-10. Petitioner’s post-operative diagnosis was a “missed
abortion (confirmed by [an] inspection of [the] gestational sac).” Id. The pathology of the uterine
contents included “hemorrhagic fragments of tissue” with no clear gestational sac or fetal tissue.
Pet’r’s Ex. 91 at 2, ECF No. 11-25.
Petitioner returned to Foothill Family Clinic on December 7, 2016, for her second MMR
vaccination. Pet’r’s Ex. 93 at 1–2, ECF No. 11-27. A history of “miscarriage” was noted. Id. She
was instructed to follow up for a third MMR vaccination in two weeks. Id.; Pet’r’s Ex. 94 at 1,
ECF No. 11-28. On December 26, 2016, Petitioner received her third MMR vaccination. Pet’r’s
Ex. 96 at 1, ECF No. 11-31. Her treater noted that a “pregnancy [sic] test [was] done earlier [that
day and] was negative.” Pet’r’s Ex. 96-2 at 2, ECF No. 11-32. Petitioner’s treater advised her
against pregnancy within the next three months “as per [the MMR vaccine] manufacturer’s
recommendation.” Id.
On April 3, 2017, Petitioner returned to Foothill Family Clinic OB/GYN with a
complaint of pain and cramps for three weeks. Pet’r’s Ex. 97 at 1–2, ECF No. 11-33. Petitioner’s
treater noted that Petitioner had heavy periods and cramps since her miscarriage. Id. On April 14,
2017, Petitioner underwent a pelvic ultrasound, which was normal. Pet’r’s Ex. 12 at 7 (also marked
“Ex. #63”), ECF No. 10; Pet’r’s Ex. 98 at 1, ECF No. 11-34. Petitioner was seen again on
November 21, 2017, for a requested pregnancy test. Pet’r’s Ex. 101 at 1–2, ECF No. 11-37. The
pregnancy test was positive, and her estimated date of delivery was July 18, 2018. Id. at 2.
Petitioner underwent testing and had a positive MMR titer on January 9, 2018, which
showed she was immune to measles and rubella, but not to mumps. Pet’r’s Ex. 104 at 1–2, ECF
No. 11-40. A February 22, 2018 ultrasound showed normal fetal anatomy and development with
normal movement. Pet’r’s Ex. 108 at 2, ECF No. 11-44. On May 3, 2018, Petitioner returned for
another ultrasound, which revealed normal growth of the fetus and normal amniotic fluid. Pet’r’s
5
Ex. 113 at 2, ECF No. 11-49. On June 13, 2018, Petitioner presented to Foothill Clinic OB/GYN.
Pet’r’s Ex. 115 at 6, ECF No. 11-51. She underwent testing that showed trace protein in her urine
and a slightly elevated blood pressure (“BP”) of 121/80. 9 Id. A check-up on June 20, 2018,
revealed that Petitioner’s protein level in her urine had returned to normal and her BP was
109/73.10 Id. On June 27, 2018, Petitioner had an elevated BP of 154/92 and increased protein in
her urine. Id. at 6–7. She was referred to Labor and Delivery to rule out preeclampsia. Id. On June
28, 2018, Petitioner was admitted to Santa Clara Valley Medical Center for induction of labor.
Pet’r’s Ex. 119 at 3, 28, ECF No. 11-55; Pet’r’s Ex. 8 at 2–3. Her preeclampsia was noted to be
severe, and her liver enzymes were greater than twice the normal level. Pet’r’s Ex. 8 at 4. Petitioner
received two doses of misoprostrol11 to induce labor. Id. However, her preeclampsia labs
worsened, and her treaters determined a cesarean section was necessary. Id. Later the same day,
Petitioner gave birth to a healthy baby boy with Apgar scores 12 of seven and nine, at one and five
minutes, respectively. Id.
b. Affidavits
i. Petitioner’s First Affidavit
Petitioner filed an affidavit entitled “Testimony about Nature, Extent and Residual
Effects.” Pet’r’s Ex. 131, ECF No. 11-67. She explained that her “testimony intends to complement
the analysis of the damage caused by the [v]accine [i]njury claimed” in her petition. Id. at 1.
Petitioner then described the negative impact that her spontaneous abortion had on her life, health,
and opinion of the United States healthcare system. Id. She reiterated that she was ill-informed at
the time of her vaccination and that she did what her treaters recommended, without understanding
the potential risks. Id. at 1–2.
ii. Petitioner’s Second Affidavit
Petitioner filed a second affidavit entitled “Corrections according to Guidelines for Practice
And fulfilling Initial Order . . . .” Pet’r’s Ex. 133, ECF No. 11-68. This document explained her
numbering system for the filing of her exhibits. See id. Petitioner cited to several exhibit numbers
in support of her claim that do not appear to have been filed in the record. See id.
iii. Petitioner’s Status Report
Petitioner’s status report filed on February 3, 2020, responded to Respondent’s Rule 4(c)
report. Pet’r’s Ex. 141, ECF No. 31. Although filed as a status report, I will construe this filing as
9
Based on this result, Petitioner’s treater made a note to “check [Petitioner’s] BP carefully [at the] next
[visit].” Pet’r’s Ex. 115 at 6.
10
Petitioner’s treater made the same notation to check Petitioner’s BP “carefully” at her next visit. Pet’r’s
Ex. 115 at 6.
11
Misoprostol is “used orally in combination with mifepristone to terminate pregnancy, acting to soften
and ripen the cervix and induce uterine contractions.” Dorland’s at 1169.
12
The Apgar score or scale is “a numerical expression of the condition of a newborn infant, usually
determined at 60 seconds after birth, being the sum of points gained on assessment of the heart rate,
respiratory effort, muscle tone, reflex irritability, and color.” Dorland’s at 1682.
6
an affidavit because of the nature of its contents, including Petitioner’s own opinions and beliefs.
See generally id.
Petitioner’s status report concluded with the following:
The Petitioner has provided great service sembling [sic] evidence to support the US
[sic] vaccination system to understand more about how vaccines can harm pregnant
women and cause the death of an in utero children [sic]. This claim is extremely
relevant to the future of human lives. Because these vaccines are still today
recommended without proper care, risking to cause [sic] more deaths.
Id. at 20.
c. Petitioner’s Expert Report
Petitioner filed an expert report written by Dr. Leslie Hansen Lindner, an obstetrician and
gynecologist with Charlotte Obstetric & Gynecologic Associates. Pet’r’s Ex. A. Dr. Hansen
Lindner included a timeline of Petitioner’s medical history beginning with her vaccination and
initial (negative) pregnancy test on the same date. Id. at 1. She noted the Center for Disease
Control’s (“CDC”) recommendation “that the MMR vaccine not be administered to a pregnant
woman due to the risk of a live attenuated vaccine crossing the placenta and causing an infectious
risk to the developing fetus.” Id. Dr. Hansen Lindner then highlighted that Petitioner received her
“MMR vaccine at the time she was pregnant, or immediately prior thereto.” Id. Petitioner then
maintained “appropriate hormonal levels” for at least two weeks post vaccination. Id. She noted
that “[t]here is no obvious cause for the miscarriage.” Id. Dr. Hansen Lindner also noted that
Petitioner “did not show any immunity to [m]umps” post-vaccination. Id.
Petitioner included in her June 21, 2021 status report an excerpt from an unfiled study13 of
a possible association between a vaccine containing pH1N1 and spontaneous abortion. ECF No.
56 at 2–3. The article was not filed in total, and the excerpt noted an association “only among
women vaccinated in the previous influenza season with [a] pH1N1-containing vaccine.” Id.
Petitioner asserted that she “believes she received the flu vaccine in 2013 and may have had the
flu in 2012, but due to the pandemic in Brazil, she has no access to those medical records.” Id. at
4–5. Petitioner included in her excerpt the authors’ statement that the study “does not and cannot
establish a causal relationship between repeated influenza vaccination[s] and [spontaneous
abortion.]” Id. She noted that “the flu vaccine has a high rate of adverse reactions, mostly mild.”
Id. at 5. Petitioner concluded this status report by noting that despite finding Dr. Hansen Linder’s
report to be inadequate, she has “not been able to find new expert support for this case,” and “will
need to proceed as is.” Id. at 6.
d. Additional Filed Evidence 14
13
Abstract of J.G. Donahue, et al., Association of spontaneous abortion with receipt of inactivated influenza
vaccine containing H1N1pdm09 in 2010–11 and 2011–12, 35(40) VACCINE 5314–22 (2017).
14
Petitioner filed medical and scientific literature in this case, but not every filed item factors into the
outcome of this Decision. While I have reviewed all the medical literature submitted in this case, I refer
only to those articles that are most relevant to my determination and/or are central to Petitioner’s case—
7
Petitioner filed an article entitled Vaccinations in Pregnancy that lists common symptoms
that result from measles, mumps, and rubella. Pet’r’s Ex. 146, ECF No. 32-5. 15 A measles infection
presents with “fever, coryza,16 a generally ill appearance, and a confluent, erythematous,
maculopapular rash,” and in very rare cases, death, “often secondary to pneumonia or
encephalitis.” Id. at 4. Mumps “can lead to parotitis, 17 meningoencephalitis, 18 and orchitis.”19 Id.
Rubella is “usually a benign infection in adults,” but it can result in birth defects. Id. Although the
study in this article “showed no evidence that [the] rubella vaccine caused any fetal abnormalities
or congenital rubella syndrome[,]” the vaccination of pregnant women is not recommended due to
“theoretic risk.” Id.
A filing by Petitioner that focuses on mumps during pregnancy notes that “infection during
the first trimester of pregnancy has been associated with an increased rate of spontaneous
abortion.” Pet’r’s Ex. 147 at 1, ECF No. 32-6. 20 It notes that the “vaccine virus has been been [sic]
recovered from the placenta, but not from the fetal tissues of pregnant women who were vaccinated
before undergoing elective abortions.” Id. Petitioner filed an abstract that also notes the presence
of the mumps virus in the placenta following vaccination, but the entire article was not filed. Pet’r’s
Ex. 148, ECF No. 32-7. 21
In her exhibit list, Petitioner identified several pieces of evidence that she related back to
specific exhibits. ECF No. 32. For example, Petitioner listed under “Evidence 10 at Exhibits #1 to
#5, #7 to #8, #11 to #12, #17 to #53” an article designated #28 and described as “Medical Article
about Rubella vaccination in Pregnancy.” Id. at 2–3. I am unable to locate such an article in the
filed record. As previously mentioned, many of Petitioner’s listed exhibits do not appear to be filed
and therefore are not available for consideration.
III. Summary of the Parties’ Arguments
a. Respondent’s Motion for Ruling on the Record
just as I have not exhaustively discussed every individual medical record filed. Moriarty v. Sec’y of Health
& Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally presume that a special master
considered the relevant record evidence even though he does not explicitly reference such evidence in his
decision.”) (citation omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x 875, 884
(Fed. Cir. 2013) (“Finding certain information not relevant does not lead to—and likely undermines—the
conclusion that it was not considered.”).
15
D.K. Sur, et al., Vaccinations in Pregnancy, 68(2) AM. FAMILY PHYS. 299–309 (2003).
16
Coryza is acute rhinitis. Acute rhinitis is “an acute congestion of the mucous membrane of the nose,
marked by dryness, followed by increased mucous secretion from the membrane, impeded respiration
through the nose, and pain.” Dorland’s at 1639.
17
Parotitis is “inflammation of the parotid gland.” Dorland’s at 1384.
18
Meningoencephalitis is “inflammation of the brain and meninges.” Dorland’s at 1134.
19
Orchitis is “inflammation of a testis, marked by pain, swelling, and a feeling of weight, often seen
accompanying epididymitis . . . . It may occur idiopathically or be associated with conditions such as
mumps, gonorrhea, filarial disease, syphilis, or tuberculosis.” Dorland’s at 1333.
20
Infections During Pregnancy – Mumps Virus, MUMPS IN PREGNANCY, perinatology.com.
21
Abstract of T. Yamauchi, et al., Transmission of Live, Attenuated Mumps Virus to the Human Placenta,
290 N. ENGL. J. MED. 710–12 (1974).
8
Respondent filed his motion for a ruling on the record dismissing Petitioner’s claim on
August 30, 2021. Resp’t’s Mot. Respondent argued that “Petitioner’s expert, Dr. Hansen-Lindner,
has failed to offer a scientifically reliable theory causally connecting the MMR or flu vaccine to
miscarriage in general, nor has [P]etitioner demonstrated a logical sequence of cause and effect or
a medically acceptable temporal relationship” between her vaccinations and alleged injuries. Id. at
11. Respondent noted that Petitioner did not file a curriculum vitae for her expert, and the report
did not list her educational or professional background. Id. at 12. Atrium Health’s website lists her
board certifications in obstetrics and gynecology and states she has been an employee since 1996.
Id. at 12–13 (citing https://atriumhealth.org/provider-profile/leslie-hansen-lindner-1649205204).
Respondent also noted that she completed her residencies in obstetrics and gynecology at the
University of Pennsylvania School of Medicine. Id. at 13.
Respondent asserted that Dr. Hansen Lindner did “not include any opinion with respect to
vaccine causation.” Id. Respondent further argued that the limited medical literature that Petitioner
filed “sets forth no theory of how the discussed flu vaccines would cause spontaneous abortion
(miscarriage) and includes a conclusion which states ‘this study does not and cannot establish a
causal relationship between repeated influenza vaccination and spontaneous abortion.’” Id. at 13–
14. The article that Petitioner submitted discusses how the flu vaccine can increase the risk of
chorioamnionitis 22 and lead to miscarriage, but Respondent argued that there is no evidence in this
case that Petitioner developed chorioamnionitis. Id. at 14.
Respondent asserted that “[P]etitioner’s treating providers did not ascribe causation to
either of the vaccinations.” Id. at 15. In fact, Dr. Graham noted that “there is no known actual risk
of [vaccination] in pregnancy, though it is not recommended to be given routinely as a matter of
caution.” Id. (citing Pet’r’s Ex. 87 at 2). Lastly, Respondent argued that without a sound theory
and a logical sequence of cause of effect, “[P]etitioner has failed to establish the requisite
appropriate temporal relationship between the MMR and/or flu vaccine and her miscarriage and
other alleged injuries.” Id. at 17.
b. Petitioner’s Response
Petitioner filed her response on December 9, 2021. Pet’r’s Resp. Petitioner argued that
“[t]he rubella part of the [MMR] vaccine is a live virus vaccine. Rubella causes miscarriage.” Id.
at 1. She relied on the CDC’s warning that “congenital rubella syndrome is a condition that occurs
in a developing baby in the womb whose mother is infected with the rubella virus,” and can result
in serious birth defects or miscarriage. Id. She continued that “[i]t is well understood that, if the
disease can do it, the vaccine can more likely than not do it, too.” Id. at 2.
Petitioner asserted that “[l]iterature provides all the information required” to establish her
burden under Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005). Id. at 1.
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Chorioamnionitis is “inflammation of the chorion and amnion.” Dorland’s at 354. The chorion is “in
human embryology, the cellular, outermost extraembryonic membrane, composed of trophoblast lined with
mesoderm; it develops chorionic villi about 2 weeks after fertilization, is vascularized by allantoic vessels
a week later, and gives rise to the fetal part of the placenta.” Id. at 355. The amnion is “the thin but tough
extraembryonic membrane of reptiles, birds, and mammals that lines the chorion and contains the embryo
and later the fetus, with the amniotic fluid around it[.]” Id. at 64.
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Pursuant to Althen, Petitioner stated that “all that must be proven is that the injury is possible, not
probable, and that a known mechanism is in place, i.e., the known characteristics of rubella and
that the timing is likely.” Id. at 3. Relying on a 21-day onset period for adverse reactions to live,
attenuated vaccines, Petitioner argued that her miscarriage at three weeks post vaccination is
within an appropriate timeframe for vaccine causation. Id. Petitioner concluded that “the live-
attenuated rubella virus in the vaccine caused the replication of the wild virus in [Petitioner] that,
in turn more likely than not, caused the miscarriage.” Id.
IV. Applicable Law
I am resolving Petitioner’s claim on the filed record. The Vaccine Act and Rules not only
contemplate but encourage special masters to decide petitions on the papers where, in the exercise
of their discretion, they conclude that doing so will properly and fairly resolve the case. See 42
U.S.C. § 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of a hearing
has been affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366
(Fed. Cir. 2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL
3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special
masters decided cases on the papers in lieu of hearing and those decisions were upheld). I am
simply not required to hold a hearing in every matter, no matter the preferences of the parties.
Hovey v. Sec’y of Health & Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that the
special master acted within his discretion in denying an evidentiary hearing); Burns v. Sec’y of
Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993); Murphy v. Sec’y of Health & Hum. Servs.,
No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).
To receive compensation under the Vaccine Act, a petitioner must demonstrate either that:
(1) the petitioner suffered a “Table injury” by receiving a covered vaccine and subsequently
developing a listed injury within the time frame prescribed by the Vaccine Injury Table set forth
at 42 U.S.C. § 300aa-14, as amended by 42 C.F.R. § 100.3; or (2) that petitioner suffered an “off-
Table injury,” one not listed on the Table, as a result of his receiving a covered vaccine. See 42
U.S.C. §§ 300aa-11(c)(1)(C); Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321
(Fed. Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1319–20 (Fed. Cir.
2006). Petitioner does not allege a Table injury in this case; thus, she must prove that her injury
was caused-in-fact by a Table vaccine.
In the seminal case of Althen v. Sec’y of the Dept. of Health & Hum. Servs., the Federal
Circuit set forth a three-pronged test used to determine whether a petitioner has established a causal
link between a vaccine and the claimed injury. See 418 F.3d at 1278–79. The Althen test requires
petitioners to set forth: “(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.”
Id. at 1278.
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355–56 (Fed.
Cir. 2006) (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound
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and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d
543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or
scientifically certain.” Knudsen, 35 F.3d at 549.
Petitioner may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325–26). This may be accomplished in a number of ways. “Reliability
and plausibility of . . . pathogenesis can be bolstered by providing evidence that at least a sufficient
minority in the medical community has accepted the theory, so as to render it credible.” See Pafford
v. Sec’y of Health & Hum. Servs., No. 01-0165V, 2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr.
July 16, 2004). Special Masters, despite their expertise, are not empowered by statute to
conclusively resolve what are complex scientific and medical questions, and thus scientific
evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian,
but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.” Andreu,
569 F.3d at 1380.
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375–77. The third Althen prong requires establishing a “proximate temporal
relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term
has been equated to the phrase “medically-acceptable temporal relationship.” Id. A petitioner must
offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given
the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation.”
de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation
for what is a medically acceptable timeframe must also coincide with the theory of how the relevant
vaccine can cause an injury (Althen prong one’s requirement). de Bazan, 539 F.3d at 1352; Shapiro
v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand on
other grounds, 105 Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013);
Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr.
May 30, 2013), mot. for review denied (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir.
2014). The special master cannot infer causation from temporal proximity alone. See Thibaudeau
v. Sec'y of Health & Hum. Servs., 24 Cl. Ct. 400, 403–04 (1991); see also Grant v. Sec'y of Health
& Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992).
A petitioner who satisfies all three prongs of the Althen test has established a prima facie
showing of causation. Hammitt v. Sec’y of Health & Hum. Servs., 98 Fed. Cl. 719, 726 (2011).
When and if a petitioner establishes a prima facie case, the burden then shifts to the government
to prove that an alternative cause, unrelated to the administration of the vaccine, was the “sole
substantial factor” in causing the alleged injury. de Bazan, 539 F.3d at 1354; see also Hammitt, 98
Fed. Cl. at 726 (explaining that the respondent’s burden is to show that the “factor unrelated” was
the “sole substantial factor” in causing the injury). Additionally, a factor unrelated “may not
include ‘any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor,
injury, illness or condition.’” 42 U.S.C. § 300aa-13(a)(2).
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V. Analysis
In Petitioner’s response to Respondent’s motion for a ruling on the record, Petitioner
asserts that “all that must be proven is that the injury is possible, not probable, and that a known
mechanism is in place.” Pet’r’s Resp. at 2. This is not the standard. Vaccine Program petitioners
bear a “preponderance of the evidence” burden of proof. § 13(1)(a). That is, a petitioner must offer
evidence that leads the “trier of fact to believe that the existence of a fact is more probable than its
nonexistence before [he] may find in favor of the party who has the burden to persuade the judge
of the fact’s existence.” Moberly, 592 F.3d at 1324. Furthermore, a petitioner must demonstrate
that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in
bringing about the injury.” Id. at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165
F.3d 1344, 1352 (Fed. Cir. 1999)); Pafford, 451 F.3d at 1355. To be clear, proof of medical
certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir.
1991). However, a petitioner may not receive a Vaccine Program award based solely on her
assertions. Rather, the petition must be supported by either medical records or by the opinion of a
competent physician. § 13(a)(1).
In the present case, Petitioner’s expert, Dr. Hansen Lindner, did not identify a biological
mechanism for the cause of Petitioner’s spontaneous abortion. Instead, her letter included the
CDC’s recommendation against MMR vaccination for pregnant women. She did not offer an
opinion on whether Petitioner’s vaccinations had any effect on Petitioner’s pregnancy. Dr. Hansen
Lindner’s letter did not otherwise offer any opinion on the cause of Petitioner’s spontaneous
abortion. Indeed, she stated in her letter that there was no obvious cause. Pet’r’s Ex. A at 1. Without
a clear medical theory casually connecting the vaccination and injury from Petitioner’s expert, I
will turn to the medical literature Petitioner filed.
The articles and online excerpts that Petitioner filed provide additional context and explain
the basis for the CDC’s recommendation against receipt of the MMR vaccine during pregnancy.
The Vaccination in Pregnancy article states that rubella can result in birth defects if the virus is
transmitted from the mother to the fetus during pregnancy. Pet’r’s Ex. 146. While this risk has
been documented with respect to the wild virus, the authors found “no evidence that [the] rubella
vaccine caused any fetal abnormalities or congenital rubella syndrome.” Id. at 4. The article
explains that with respect to the vaccine, the authors’ only aim is to note evidence of a “theoretic
risk.” Id. Indeed, there is no evidence in this case that Petitioner developed a rubella infection.
Petitioner did not report any symptoms of rubella at any point during her pregnancy. Her medical
providers never suspected that she suffered from rubella or any other infection during her
pregnancy. Furthermore, there is no evidence that, during her pregnancy, the rubella virus was
transmitted through the placenta and subsequently infected the fetus. There was concern, however,
that Petitioner’s pregnancy may have been ectopic or otherwise nonviable (e.g., with an ultrasound
that revealed an intrauterine cystic structure without a yolk sac or embryonic pole), completely
unrelated to her receipt of the vaccines. Petitioner has not produced preponderant evidence that
her spontaneous abortion was due to a rubella infection from the MMR vaccine.
A second article filed by Petitioner discussed the potential risk of spontaneous abortion in
the first trimester as a result of the mumps infection. Pet’r’s Ex. 147. This article also cited a study
that did not find evidence of the mumps virus in fetal tissue from women vaccinated during
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pregnancy. Id. Dr. Hansen Lindner highlighted the notation in Petitioner’s medical records that
she did not show any immunity to mumps. Pet’r’s Ex. A at 1. This is evidence that Petitioner did
not develop a mumps infection and therefore did not transmit any such infection to the fetus during
pregnancy.
Petitioner’s assertion that the flu vaccine has an association with miscarriages is
unsupported. In her status report immediately preceding Respondent’s motion for a ruling on the
record, Petitioner included an excerpt from an unfiled study of a possible association between a
vaccine containing pH1N1 and spontaneous abortion. ECF No. 56 at 3. The article was not filed
in total, and the excerpt noted an association “only among women vaccinated in the previous
influenza season with [a] pH1N1-containing vaccine.” Id. The authors were clear that the study
does not and cannot establish a causal relationship between “repeated influenza vaccinations and
[spontaneous abortion.]” Id. As Petitioner notes, the flu vaccine is recommended for pregnant
women. She also asserts that a section of the CDC website entitled Vaccines for Your Children:
Vaccine for Flu “tends to show that a flu vaccine can cause this injury.” Id. at 5. This webpage
focuses on the vaccination of young children and includes a frequently-asked-question section that
asks, for example, “why should my child get a flu vaccine” and “is the flu serious?” See
https://www.cdc.gov/vaccines/parents/diseases/flu.html. Incidentally in response to the question,
“should pregnant women get vaccinated?,” the CDC website states “yes” and notes a woman “can
be vaccinated during any trimester of [her] pregnancy.” Id. The webpage does not discuss any
potential risk of miscarriage posed by the flu vaccine.
Petitioner did not file persuasive evidence to support a claim that her October 15, 2016
influenza vaccination could be the cause-in-fact of her spontaneous abortion. Dr. Hansen Lindner
made no mention of the flu vaccine in her letter. Petitioner’s medical records do not include her
vaccination history. Petitioner presented no evidence that she received a vaccine containing
pH1N1 in the year preceding her spontaneous abortion, or any prior year. She asserted that she
“believes she received the flu vaccine in 2013 and may have had the flu in 2012.” ECF No. 56 at
4. Even assuming that is true, Petitioner’s medical history is still inconsistent with the case studies
briefly described in her excerpted medical literature.
Petitioner has not provided preponderant evidence that her MMR or flu vaccines can cause
spontaneous abortion, or that they did in her case. Petitioner argues that a three-week period
between vaccination and spontaneous abortion is appropriate to infer causation. Without any
biological mechanism for context, it is impossible to determine an appropriate temporal
relationship in this case. In any event, a temporal relationship would be of no consequence without
a medical theory and a logical sequence of cause and effect.
Of note, in multiple filings, Petitioner has expressed dissatisfaction with her expert report.
ECF Nos. 56, 59. She also acknowledged reasonable basis concerns that she did not subsequently
address in full. ECF No. 59. Indeed, she has been unable to obtain an additional expert report in
support of her claim, despite multiple opportunities to do so. While this Program does contemplate
pro se petitioners, all claimants, regardless of representation status, must provide preponderant
evidence of vaccine causation. It is clear from the medical records that there is not preponderant
evidence that Petitioner’s vaccines caused her spontaneous abortion. In fact, Petitioner’s claim is
also contrary to her partially submitted literature. To overcome the purported lack of reasonable
13
basis in this case, Petitioner relies on a general recommendation from the CDC, and further argues
that “the [V]accine [A]ct forbids use of any idiopathic theory as to an unrelated cause to defeat a
[] claim.” Pet’r’s Mot. Fees at 2, ECF No. 62. Petitioner is correct that once a prima facie case is
established, Respondent cannot simply assert the possibility of an idiopathic cause to successfully
rebut a claim. In this case, however, Petitioner has not established a prima facie case. Furthermore,
this is not a Table claim. As such, there is no presumption of causation based solely off an
identified vaccine and a specific injury. Respondent therefore has no burden to provide any
evidence or rebut any of Petitioner’s evidence.
VI. Conclusion
Petitioner has experienced an immeasurable loss, and I have reviewed the entire record in
an effort to understand what happened to her. In this Program, many of the most serious and life-
changing conditions that petitioners experience remain idiopathic. As noted in the case filings, first
trimester spontaneous abortions are not rare events. Despite their frequency, it can be difficult to
determine the cause in many cases. This, unfortunately, is such a case. Petitioner has not met her
burden to establish that but-for her vaccinations, she would not have suffered a spontaneous
abortion and severe preeclampsia. Therefore, her claim must be DISMISSED.
IT IS SO ORDERED.
s/Herbrina D. Sanders
Herbrina D. Sanders
Special Master
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