VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-01551 Package ID: USCOURTS-cofc-1_17-vv-01551 Petitioner: A.r.d-C. Filed: 2017-10-07 Decided: 2019-09-25 Vaccine: DTaP Vaccination date: 2016-06-23 Condition: hemophagocytic lymphohistiocytosis (HLH) and acute myeloid leukemia (AML) Outcome: dismissed Award amount USD: AI-assisted case summary: Robert David Dupuch-Carron and Elizabeth Joanna Carron, as legal representatives of the estate of their minor son, A.R.D-C., filed a claim under the National Vaccine Injury Compensation Program on October 7, 2017. A.R.D-C. was born in The Bahamas and received DTaP, IPV, HIB, HBV, Prevnar, and rotavirus vaccines on June 23, 2016, in The Bahamas. Within two weeks, he developed symptoms including fever, irritability, and reduced appetite, leading to diagnoses of pancytopenia and febrile neutropenia. He was transferred to Miami, Florida, for treatment and diagnosed with hemophagocytic lymphohistiocytosis (HLH). Later, he was diagnosed with acute myeloid leukemia (AML) and underwent extensive treatment, ultimately passing away on December 24, 2017, from AML. The parents alleged that the AML was a complication resulting from the treatment for vaccine-induced HLH. The core issue was the petitioners' eligibility under the Vaccine Act, specifically whether A.R.D-C. met the requirement of having received a vaccine outside the United States and then 'returned' to the United States within six months. The Special Master, Thomas L. Gowen, found that A.R.D-C.'s entry into the United States for medical treatment, after being vaccinated in The Bahamas, did not constitute a 'return' as contemplated by the Act, which requires a more substantial connection to the United States than a temporary visit for medical care. The Special Master denied the petitioners' motion for summary judgment and granted the respondent's, dismissing the petition for lack of eligibility. The petitioners filed a motion for review, which was heard by Judge Richard A. Hertling. Judge Hertling reviewed the Special Master's decision de novo and affirmed the dismissal, finding that A.R.D-C.'s entry into the United States for medical treatment did not satisfy the statutory requirement of a 'return' within the context of the Vaccine Act. The petition was dismissed. Theory of causation field: Petitioners, Robert David Dupuch-Carron and Elizabeth Joanna Carron, filed a claim on behalf of their son, A.R.D-C., who received DTaP, IPV, HIB, HBV, Prevnar, and rotavirus vaccines on June 23, 2016, in The Bahamas. The petitioners alleged that these vaccines caused hemophagocytic lymphohistiocytosis (HLH) and subsequently acute myeloid leukemia (AML), leading to the child's death on December 24, 2017. The claim was dismissed by Special Master Thomas L. Gowen and affirmed by Judge Richard A. Hertling because A.R.D-C. did not meet the eligibility requirement under 42 U.S.C. § 300aa-11(c)(1)(B)(III) of having 'returned' to the United States within six months of vaccination. A.R.D-C. was vaccinated in The Bahamas and subsequently entered the United States for medical treatment, which the court determined did not constitute a 'return' as intended by the Vaccine Act, emphasizing the need for a more substantial connection to the U.S. than a temporary medical visit. The public decision does not describe the specific mechanism of causation or name any experts. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_17-vv-01551-0 Date issued/filed: 2019-05-28 Pages: 13 Docket text: PUBLIC DECISION (Originally filed: 4/23/19) regarding 24 DECISION of Special Master. Signed by Special Master Thomas L. Gowen. (kb) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 1 of 13 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed April 23, 2019 * * * * * * * * * * * * * * * ROBERT DAVID DUPUCH-CARRON * and ELIZABETH JOANNA CARRON, * as the legal representatives of the estate of * their minor son, A.R.D-C., * PUBLISHED * Petitioners, * No. 17-1551V * v. * Special Master Gowen * SECRETARY OF HEALTH * Eligibility for Compensation; AND HUMAN SERVICES, * “Person”; “Returned”. * Respondent. * * * * * * * * * * * * * * * * Curtis R. Webb, Twin Falls, ID, for petitioners. Meredith B. Healy, U.S. Department of Justice, Washington, DC, for respondent.1 DECISION2 Robert David Dupuch-Carron and Elizabeth Joanna Carron (“petitioners,” or “father” and mother”) are the legal representatives of the estate of their minor son, A.R.D-C. The family is domiciled in The Bahamas. Ms. Carron carried A.R.D-C. in utero upon five visits to the United States. On November 24, 2015, A.R.D-C. was born in The Bahamas. On June 23, 2016, A.R.D- C. received DTaP, IPV, HIB, HBV, Prevnar, and rotavirus vaccines at his pediatrician’s office in The Bahamas. He remained in The Bahamas until July 13, 2016, when he was transported to the United States for treatment for secondary hemophagocytic lymphohistiocytosis (“HLH”). 1 Lynn E. Ricciardella was respondent’s previous counsel of record and filed respondent’s cross-motion for summary judgment. Afterwards, Meredith B. Healy substituted as respondent’s counsel on August 30, 2018. Notice of Appearance (ECF No. 22). 2 Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this opinion contains a reasoned explanation for the action in this case, I am required to post it on the website of the United States Court of Federal Claims. The court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. This means the opinion will be available to anyone with access to the Internet. Before the opinion 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: (1) 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 opinion. Id. If neither party files a motion for redaction within 14 days, the opinion will be posted on the court’s website without any changes. Id. Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 2 of 13 A.R.D-C. later developed secondary complications and passed away in the United States on December 24, 2017. On October 7, 2017, petitioners initiated a claim within the National Vaccine Injury Compensation Program, alleging that A.R.D-C.’s March 26, 2016 vaccines caused his injuries and death.3 Petition (ECF No. 1); see also Amended Petition filed March 26, 2018 (ECF No. 15). Ripe for adjudication is whether petitioners’ claim is eligible under 42 U.S.C. § 300aa- 11(c)(1)(B)(III), which provides that the vaccination(s) at issue must be received by a “person” who then “returns” to the United States within six months. Petitioners contend that this threshold eligibility requirement is fulfilled on the grounds (1) that A.R.D-C. was a “person” upon entering the United States while in utero and that (2) A.R.D-C. “returned” to the United States within six months under a plain meaning of that quoted word. Petitioners’ Motion for Summary Judgment (“Pet. Mot.”) (ECF No. 11); Pet. Reply (ECF No. 21); see also Pet. Exhibits (“Exs.”) 1-16. Respondent challenges both contentions. Respondent’s Cross-Motion for Summary Judgment (“Resp. Mot.”) (ECF No. 18). After carefully analyzing and weighing all of the evidence presented in this case in accordance with the applicable legal standards, I hereby DENY petitioners’ motion for summary judgment and GRANT respondent’s motion for summary judgment, finding that the petition is not eligible under 42 U.S.C. § 300aa-11(c)(1)(B)(III). Accordingly, petitioners may not proceed in seeking compensation from this Program and their petition is dismissed. I. Summary of Relevant Facts4 A. Family’s Connections to the United States The Dupuch-Carron family – the father Mr. Dupuch-Carron, the mother Ms. Carron, the paternal grandmother Ms. Eileen Dupuch-Carron, and A.R.D-C. during his life – were domiciled in Nassau, The Bahamas. Additionally, the grandmother, through a company established by her parents, Sir Etienne Dupuch and Lady Marie Dupuch, also owns a condominium in Coral Gables, Florida. Pet. Ex. 16 ¶ 5. She is a “frequent visito[r] to the United States,” “spend[ing] 10 to 12 long weekends in the United States a year.” Id. ¶ 4. The father was born in the United States. Pet. Ex. 16 ¶ 5. He recalls “spen[ding] a great deal of time here as a child during the summer holidays with his grandparents.” Id. Mr. Carron is a “frequent visitor to the United States,” spending “between 30 and 45 days in the United States on business” in a typical year. Id. ¶ 3. 3 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-10 et seq. (hereinafter “the Vaccine Act” or “the Act”). 4 In order to reach this decision, I fully reviewed the entire record. This section is a summary of the facts deemed most relevant to the present limited issue: as a threshold matter, whether petitioners are eligible to receive compensation from the Vaccine Program. 2 Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 3 of 13 The mother is a citizen of the United Kingdom and a resident of The Bahamas. Pet. Ex. 11 at 7. Her pregnancy with A.R.D-C. was confirmed by an internist in Coral Gables, Florida during a visit to the United States from March 24, 2015 to April 3, 2015. Pet. Ex. 11 at 12-22; Pet. Ex. 10 ¶ 31. While pregnant, she made four additional visits to the United States: from April 9, 2015 to April 11, 2015; from July 1, 2015 to July 3, 2015; from August 12, 2015 to August 14, 2015; and from September 18, 2015 to October 5, 2015. Pet. Ex. 11 at 12-22; Pet. Ex. 10 ¶ 31. The father avers that “[B]efore [A.R.D-C.’s] illnesses and death, [the mother] probably spent more time in the United States than I.” Pet. Ex. 16 ¶ 4. B. A.R.D-C.’s Early Life, Vaccines at Issue, and Entry to the United States A.R.D-C. was born on November 24, 2015, at Doctors Hospital in Nassau, The Bahamas. Pet. Ex. 2. “During his first six months,” A.R.D-C. lived with his mother, father, and grandmother in Nassau, The Bahamas. Pet. Ex. 16 ¶ 2. A.R.D-C. had unremarkable well-child visits at Precious Posterity Pediatric Centre in Nassau, The Bahamas on November 30, 2015; December 22, 2015; January 26, 2016; February 26, 2016; April 14, 2016; and April 25, 2016. Pet. Ex. 3 at 2-12, 19. On June 23, 2016, A.R.D-C. presented to the same practice for his six-month well-baby visit. He received the DTaP, IPV, HIB, HBV, Prevnar, and rotavirus vaccines at issue in this case. Id. at 13-14, 19. On July 7, 2016, and again July 9, 2016, the parents brought A.R.D-C. to the same pediatric practice for complaints of fever greater than 102 degrees Fahrenheit, crankiness, stuffy nose, rattling in chest, occasional chesty coughs, reduced activity, vomiting, and diarrhea. Id. at 15-16. A.R.D-C. was assessed with “likely viral illness, [rule out] sepsis” and discharged home with Cardec drops. Id. at 16. On July 10, 2016, the parents brought A.R.D-C. to the emergency room at Doctors Hospital in Nassau, The Bahamas for complaints of fever for five days, vomiting for five days, irritability, and decreased appetite. Pet. Ex. 4 at 2. He was found to have thrombocytopenia,5 pancytopenia6 for which he was given a blood transfusion, and febrile neutropenia for which he was given intravenous Zosyn, an antibiotic.7 Pet. Ex. 4 at 4, 12; Pet. Ex. 5 at 7. On July 11, 2016, A.R.D-C. was transferred to the intensive care unit at Princess Margaret Hospital in Nassau, The Bahamas. Pet. Ex. 5. Repeat bloodwork showed worsened neutropenia. Id. at 7. He was diagnosed with “febrile neutropenia with pancytopenia” with the need to rule out leukemia, bacterial sepsis, and viral infection. Id. A pediatric hematologist- 5 Thrombocytopenia is “a decrease in the number of platelets.” Dorland’s Illustrated Medical Dictionary (32nd ed. 2012) [hereinafter “Dorland’s”] at 1922. 6 Pancytopenia is “deficiency of all cellular components of the blood.” Dorland’s at 1368. 7 Neutropenia is “an abnormal decrease in the number of neutrophils in the blood.” Dorland’s at 1272. 3 Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 4 of 13 oncologist recommended that A.R.D-C. should be transferred to an institution that was “equipped to enable quick turn around and confirmation of the leukemia if present” and was able to provide immunophenotyping, cytogenetic evaluation, and reliable blood bank support. Id. Those capabilities were “unavailable” or “limited” in The Bahamas. Id. On July 12, 2016, The Bahamas issued a passport to A.R.D-C. Pet. Ex. 11 at 3. That same day, the United States granted him a visa. The purpose for entering the United States was “medical.” Id. at 4-5. On July 13, 2016, A.R.D-C. was transferred by air ambulance to Nicklaus Children’s Hospital in Miami, Florida, where his diagnosis was modified to hemophagocytic lymphohistiocytosis (“HLH”).8 He was treated for that condition until discharge on August 12, 2016. Pet. Ex. 6 at 12-13. The mother recalls that A.R.D-C. was discharged “on the condition he remain in Florida as an outpatient.” Pet. Ex. 10 ¶ 18. “Instead of traveling back home to The Bahamas, we took up residence in our family’s apartment in Coral Gables.” Id. A.R.D-C. continued to see hematologist-oncologist Dr. Maggie Fader as an outpatient of Miami Children’s Hospital on a weekly basis. Id. ¶ 19. The family was “finally given permission to leave the USA on Christmas Eve 2016 provided [they] come back to Miami Children’s Hospital for monthly visits to Dr. Maggie Fader.” Id. A.R.D-C. was able to return briefly to The Bahamas from December 24, 2016 to January 24, 2017, and again from January 29, 2017 to February 20, 2017. Pet. Mot. Memorandum (“Mem.”) at 3. A.R.D-C. spent the remaining ten months of his life in the United States in connection with his medical treatment. On February 28, 2017, he was readmitted to Nicklaus Children’s Hospital in Florida due to a rash that had spread over his body which was diagnosed as myeloid sarcoma. Pet. Ex. 7 at 6; Pet. Ex. 10 at ¶ 21. A.R.D-C. underwent a bone marrow aspiration and was diagnosed with treatment-related acute myeloid leukemia. See Pet. Ex. 7; Pet. Ex. 10 at ¶ 22. A.R.D-C. underwent further treatment, including chemotherapy and radiation, primarily at Miami Children’s. He was also evaluated at Cincinnati Children’s Hospital in Ohio and underwent extensive treatment including a bone marrow transplant at Johns Hopkins Bloomberg Children’s Hospital in Maryland. Pet. Ex. 10 at ¶ 26. Sadly, on December 24, 2017, A.R.D-C. died from treatment-related acute myeloid leukemia at Johns Hopkins. Pet. Ex. 15. II. DISCUSSION A. Introduction The threshold issue to be resolved is whether A.R.D-C. can be deemed to have “returned” to the United States within six months after receiving the vaccines giving rise to this claim, 8 Hemophagocytic lymphohistiocytosis is “any of several closely related disorders involving both lymphocytosis and histiocytosis, with excessive hemophagocytosis in the lymphoreticular system or the central nervous system; they are usually seen in children secondary to infection and are often fatal; they can also be secondary to rheumatologic or other conditions or can be familial.” Dorland’s at 1085. 4 Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 5 of 13 pursuant to 42 U.S.C. § 300aa-11(c)(1)(B)(III), as required to be eligible to receive compensation under the Vaccine Act. The Vaccine Act was established to compensate vaccine-related injuries and deaths. 42 U.S.C. §300aa-10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as a simple, fair and expeditious means for compensating vaccine-related injured persons. The Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty and generosity.’” Rooks v. Sec'y of Health & Human Servs., 35 Fed. Cl. 1, 7 (1996) (quoting H.R. Rept. No. 99-908, 99th Cong., 2d Sess. at 3 (reprinted in 1986 U.S.C.C.A.N. at 6287, 6344)). The Vaccine Act provides that a “person” is eligible to seek compensation in the Program upon establishing certain requirements including receipt of a vaccine listed on the Vaccine Injury Table and the showing of a sufficiently severe injury. Additionally, the person must establish that he or she: (I) received the vaccine in the United States or its trust territories, (II) received the vaccine outside the United States or a trust territory and at the time of the vaccination such person was a citizen of the United States serving abroad as a member of the Armed Forces or otherwise as an employee of the United States or a dependent of such a citizen, or (III) received the vaccine outside the United States or a trust territory and the vaccine was manufactured by a vaccine manufacturer located in the United States and such person returned to the United States not later than 6 months after the date of the vaccination. 42 U.S.C. § 300aa-11(c)(1)(B) (emphasis added). The Federal Circuit described the various subsections of 42 U.S.C. § 300aa-11 as “gate- keeping” provisions. Amendola v. Sec’y of Health & Human Servs., 989 F.2d 1180, 1182 (Fed. Cir. 1993). If a petitioner is unable to satisfy the requirements of these gatekeeping provisions, “any injury caused by [the vaccine’s] administration is not compensable, and the injured party has no cognizable claim under the Vaccine Act.” Scanlon v. Sec’y of Health & Human Servs., 114 Fed. Cl. 135, 141 (2013). It is clear that that A.R.D-C. did not receive the vaccines at issue in the United States or its trust territories, as required to be eligible to receive compensation under subsection (I). It is also clear that he received the vaccines outside the United States and its trust territories, however, there is no evidence that he is a dependent of a United States citizen who was serving abroad as a member of the Armed Forces or otherwise as an employee of the United States. The only remaining subsection is (III). There is no dispute that the vaccines at issue were made by “vaccine manufacturer[s] located in the United States” and that they were administered to A.R.D-C. outside of the United States. Pet. Exs. 12-14; Pet. Mot. Mem. at 5-8; Resp. Mot. at 4. It is undisputed that A.R.D-C. came to the United States for medical treatment twenty (20) days after receiving the vaccines at issue. However, A.R.D-C.’s eligibility to seek compensation 5 Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 6 of 13 under this subsection remains to be determined. First, it refers to a “person.” This raises the question of whether under the Act’s meaning, A.R.D-C. was a “person” when he was carried in utero to the United States. After his birth, he did not enter the United States until after the vaccinations when he entered for medical treatment. Additionally, even if it is accepted that A.R.D-C. was a “person” while in utero, the further question is whether he “returned” under the Vaccine Act. B. “Such person returned to the United States” Petitioners argue that A.R.D-C. returned to the United States after his vaccinations because he previously entered the country five times while in utero. “As a matter of law, a child who is in utero is a person for the purposes of the National Vaccine Injury Compensation Program.” Pet. Mot. Mem. at 13, citing Rooks, 35 Fed. Cl. 1 (holding that a vaccination given to a pregnant woman can be “received” by a child in utero); Burch v. Sec’y of Health & Human Servs., No. 99-946V, 2010 WL 1676767 (Fed. Cl. Spec. Mstr. April 9, 2010) (same); Melton v. Sec’y of Health & Human Servs., No. 01-105V, 2002 WL 229781 (Fed. Cl. Spec. Mstr. Jan. 25, 2002) (same). In 2016, Congress expressly amended the Vaccine Act to recognize this principle: (11) Petitions for Compensation… (f) Maternal immunization. (1) Notwithstanding any other provision of law, for the purposes of this subpart, both a woman who received a covered vaccine while pregnant and any child who was in utero at the time such woman received the vaccine shall be considered persons to whom the covered vaccine was administered and persons who received the covered vaccine. (2) Definition. As used in this subsection, the term “child” shall have the meaning given that term by subsections (a) and (b) of Section 8 of Title 1… 42 U.S.C. § 300aa-119 (emphasis added), cited in Pet. Mot. Mem. at 13. “Child” is defined: (a) In determining the meaning of any Act of Congress, or of any ruling, regulation, or interpretation of the various administrative bureaus and agencies of the United States, the words “person”, “human being”, “child”, and “individual”, shall include every infant member of the species homo sapiens who is born alive at any stage of development. (b) As used in this section, the term “born alive”, with respect to a member of the species homo sapiens, means the complete expulsion or extraction from his or her mother of that member, at any stage of development, who after such expulsion or 9 As amended by the wide-ranging 21st Century Cures Act, P.L. 114-255, December 13, 2016, 130 Stat. 1033. The 21st Century Cures Act also amended the Vaccine Injury Table “to include vaccines recommended by the Centers for Disease Control and Prevention for routine administration in pregnant women” and amended the Vaccine Act to provide that “A covered vaccine administered to a pregnant woman shall constitute more than one administration, one to the mother and one to each child… who was in utero at the time such woman was administered the vaccine.” Id. 6 Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 7 of 13 extraction breathes or has a beating heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, regardless of whether the umbilical cord has been cut, and regardless of whether the expulsion or extraction occurs as a result of natural or induced labor, cesarean section, or induced abortion. (c) Nothing in this section shall be construed to affirm, deny, expand, or contract any legal status or legal right applicable to any member of the species homo sapiens at any point prior to being “born alive” as defined in this section. 1 U.S.C. § 8. Respondent contends that the recent maternal immunization amendment to the Vaccine Act establishes that a child in utero can “receive” a vaccine but it does not establish that the child in utero was “present” in the United States for purposes of a later “return.” Resp. Mot. at 5, n. 4. In this case, respondent argues that the mother’s entries into the United States while pregnant do not mean that A.R.D-C. was “present” in the United States prior to birth. Furthermore, A.R.D-C. was not present in the United States at any time between his birth and his vaccinations. His first entry into the United States was after he was born in The Bahamas and received the vaccines at issue in The Bahamas, for treatment of his post-vaccination injury on July 13, 2016. “As a matter of logic,” that post-vaccination entry into the United States cannot constitute a “return.” Resp. Mot. at 5; id., n. 4.10 I agree with respondent. Congress did expressly amend the Vaccine Act to permit a cause of action alleging that a child was injured by transplacental exposure to a vaccine administered to his or her mother (but only after that child was born alive). This cause of action was previously in question and not expressly recognized under the Act. See, e.g., Rooks, 35 Fed. Cl. 1; Burch, 2010 WL 1676767; Melton, 2002 WL 229781 (all analyzing this issue). However, this amendment did not change the definition of child or person under any other sections of the law – such as the section requiring that a “person” “return” to the United States to be eligible to file a claim. Congress did not amend the Vaccine Act to expand who constitutes a person who can be deemed a person for purposes for later “return” to the United States. Additionally, the applicable definition of “person” specifies that it shall not be construed to “affirm, deny, expand, or contract any legal status or legal right applicable to any member of the species homo sapiens at any point prior to being ‘born alive’ as defined therein.” 1 U.S.C. § 8. If Congress wished to amend that section of the Act, it could have done so. Without express expansion by Congress, the Court is not inclined to make that finding. As such, the amendment to the Vaccine Act does not appear to establish that a pregnant woman’s presence in the United States creates a separate presence of the fetus in the United States before birth. 10 Strangely, petitioners’ reply provides: “Respondent apparently concedes that these [in utero] visits establish [A.R.D-C.’s] ‘entry’ into the United States and ‘presence’ in the United States as a visitor.” Pet. Resp. at 11 (emphasis added, citing Resp. Mot. at 5 and id., n. 4. This does not seem correct. My understanding is that respondent does not accept that the visits to the United States while A.R.D-C. was in utero count for determining whether A.R.D-C. could later “return.” 7 Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 8 of 13 In this case, A.R.D-C., while living and breathing outside of his mother’s body, was never present in the United States before his vaccinations or the onset of his severe illness which necessitated his subsequent entry for medical treatment. Thus, his entrance to the United States, while within six months after the vaccinations at issue, cannot be construed as a “return.” C. “Such person returned to the United States” Even if A.R.D-C. is recognized as a “person” who was present in the United States before vaccination, the parties still disagree whether A.R.D-C. did “return to the United States not later than six months after the date of vaccination.” § 300aa-11(c)(1)(B)(III). “Return” is not defined in the Vaccine Act. Petitioners argue that the analysis should start and end with the plain meaning. They cite the Supreme Court’s decision in Sebelius v. Cloer for the proposition that: “As in any statutory interpretation case, [the Court starts,] of course, with the statutory text, and proceeding from the understanding that unless otherwise defined, statutory terms are generally interpreted in accordance with their ordinary meaning.” Sebelius v. Cloer, 569 U.S. 369, 376 (2013) (analyzing the ordinary meaning of “filed” in the Vaccine Act). Petitioners argue that similarly, here, the “common, ordinary, and accepted meaning” of “return” should be applied. Pet. Mot. Mem. at 8-9, citing Cloer, 569 U.S. at 376- 80; Nuttall v. Sec’y of Health & Human Servs., No. 7-810V, 2015 WL 691272, *10 (Fed. Cl. Spec. Mstr. Jan. 20, 2015); Waddell v. Sec’y of Health & Human Servs., No. 10-316V, 2012 WL 5504421, *8 (Fed. Cl. Spec. Mstr. Sept. 20, 2012). Petitioners cite several dictionary definitions which provide that “return” means simply to “go back” to a place or person. Pet. Mot. Mem. at 9 (internal citations omitted). Neither respondent or this Court has located alternative definitions for the word “return.” However, those definitions submitted by petitioners are still non-specific. “Return” is used in a variety of contexts and the sense of permanence depends on the subject of the return. Here, the Vaccine Act’s requirement that a person “returned to the United States” might be understood to be limited to scenarios such as where a person who previously lived in the United States was travelling or working for a limited period of time in a foreign country, where he or she received a vaccine, then “returned” to the United States intending to remain indefinitely. But if “return” is read more broadly, a person who entered the United States once for any length of time and for any purpose (such as tourism, visiting family, medical treatment, or business) returned to his or her country of residence where he or she received a vaccine, and who entered the United States again for any length of time and for any purpose within six months of the vaccination could be deemed to “return” and therefore be eligible to file a petition under the Vaccine Act. This reading seems overly broad. In this sense, the meaning of “return” is ambiguous. See McGowan v. Sec’y of Health & Human Servs., No. 90-2446V, 1994 WL 879451 (Fed. Cl. Spec. Mstr. May 10, 1994), mot. for rev. denied, 31 Fed. Cl. 734, 738 (1994) (reasoning that dictionary definitions “shed little light” and “[s]ince the word “return” relies on its context in order to impart a sense of permanence, the plain meaning rule is not dispositive”)11; Sutherland Statutes and Statutory Construction (7th ed. 11 Both parties note that McGowan is the only case analyzing the requirement that a person “return to the United States not later than six months after the date of vaccination” under Vaccine Act Section 11(c)(1)(B)(III). Pet. Mot. 8 Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 9 of 13 2018) (hereinafter “Sutherland’s”) at § 45:2, The problem of ambiguity (“Modern courts typically frame the issue by stating that ambiguity exists when a statute is capable of being understood by reasonably well-informed persons in two or more different senses.”). In Cloer, the Supreme Court noted that where the words of the Vaccine Act are “unambiguous,” the plain meaning governs. However, where there is more than one meaning, certain canons and policy arguments come into play. 569 U.S. at 380-81. As noted by respondent, the Vaccine Act is a limited waiver of sovereign immunity which should be given a “strict and narrow construction.” Any ambiguity must be construed “in favor of the sovereign.” Holihan v. Sec’y of Health & Human Servs., 45 Cl. 205, 207 (1999), cited in Resp. Mot. at 8 While interpretation of statutory text, including the Vaccine Act, should begin with the plain meaning it should not produce absurd results. Cloer, 569 U.S. at 1894, n. 4; see also Hellebrand v. Sec’y of Health & Human Servs., 999 F.3d 1566, 1570-71 (Fed. Cir. 1993); McGowan, 31 Fed. Cl. at 739 (“To rule that ‘return’ means simply to physically enter the United States is to invite absurd scenarios”). As respondent notes, a court does “not construe statutes in a vacuum, and ‘the words of a statute must be read in their context and with a view to their place in the overall statutory scheme.’” Resp. Mot. at 7, citing Colonial Press Int’l v. U.S., 788 F.3d 1350, 1356 (Fed. Cir. 2015) (quoting Davis v. Mich. Dep’t of Treasury, 489 U.S. 803, 809 (1989)). When interpreting a statute, a court is “not guided by a single sentence or number of sentences but look[s] to the provisions of the whole law, and to its object and policy.” Resp. Mot. at 7, citing Dole v. United Steelworkers of Am., 494 U.S. 26, 34 (1990). Congress had two main goals upon passing the Vaccine Act. The first was to stabilize the national vaccine market. Cloer, 569 U.S. at 372 (stating that the Act was passed in response to an increase in vaccine-related tort litigation); Bruesewitz v. Wyeth LLC, 562 U.S. 223, 228-29 (2011) (recounting that an increasing number of vaccine product liability suits, associated with the withdrawal of several manufacturers and vaccine shortages within the United States) (internal citations omitted); McGowan, 31 Fed. Cl. at 738-39. Petitioners assert that: “A person who is [allegedly] injured by a vaccine manufactured by ‘a vaccine manufacturer located in the United States’ can sue the manufacturer in a traditional negligence or product liability action in Mem. at 9-11; Resp. Mot. at 5-8; Pet. Resp. at 9-10. McGowan concerned a child who was born in the United States in 1964, then moved to Canada where her father was undergoing medical training. While in Canada, she received a measles vaccination and developed convulsions. The child continued to live in Canada apart from intermittent trips to visit her grandparents who were living in the United States – including at least one trip within six months of the vaccination at issue. The child and her parents did not return to live permanently in the United States until over two years after the vaccination, in 1967. The special master dismissed the claim and the Court of Federal Claims affirmed, both holding that the word “returned” was not addressed in the legislative history but was limited to persons who had previously lived in the United States and returned within six months of vaccination with the intention to remain permanently from that point on. See 31 Fed. Cl. at 734-740. Of course, opinions of special masters and the U.S. Court of Federal Claims constitute persuasive but not binding authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121, 124 (2003), aff’d, 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014). 9 Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 10 of 13 the country where the vaccine was administered.” Pet. Resp. at 8. “Such suits would create the same kind of expenses, liability concerns, and disruption of the vaccine market as those arising from vaccinations administered in the United States.” Id. Bringing “some of those cases,” those filed by prior visitors to the United States who enter again within six months, would “protect vaccine manufacturers located in the United States from vaccine-injury liability and stabilize the vaccine market.” Id. Congress undisputedly intended to reduce liability for those manufacturers. However, if Congress wished to provide such broad immunity as argued by the petitioners, it is hard to see why Congress disallowed claims by persons who never entered the United States or entered the United States at some point before vaccination but did not return again within six months. Congress only made eligible those persons who had previously entered the United States and entered again within six months after vaccination. It seems more likely that Congress, in enacting this section, intended to provide protection for persons who were temporarily away from the United States but who returned within six months after vaccination with an intent to stay.12 Congress’s second expressed goal was to compensate individuals suffering injury following vaccination. Cloer, 569 U.S. at 372 (“Congress enacted the NVCIA to… expedite compensation to injured parties”); Bruesewitz, 562 U.S. at 226-29 (“to facilitate compensation”); McGowan, 31 Fed. Cl. at 738 (“to “offer fair compensation to victims”). In the legislative history, Congress specifically noted that vaccination programs are facilitated by state and local distribution of vaccines. Additionally, at the time of the Act’s passage, state laws mandated that “virtually all” children be vaccinated “as a condition for entering school.” H.R. Rep. No. 99-908 at *4-7.13 The legislative history is generally focused on public health within the United States. Petitioners characterize this purpose of compensation broadly as “humanitarian.”14 Pet. Resp. at 7. This interpretation is overly broad. Congress did not evince any concern about persons possibly injured by vaccines outside of and without any connection to the United States 12 A further limitation is found in how the Vaccine Program is funded. Upon passing the Vaccine Act, Congress decided that it would be funded by an excise tax on the vaccines covered. Originally, taxes were set at different rates to reflect “the currently accepted views regarding the relative reactogenicity of [different] vaccines.” The number of doses of each vaccine distributed in the United States was used to estimate the revenues generated per year. H.R. 99-908 at *34. In 1997, the funding scheme changed to a uniform tax of seventy-five cents ($0.75) levied on “any taxable vaccine sold by the manufacturer, producer, or importer thereof.” 26 U.S.C. § 4131; I.R.C. § 4131. “The manufacturer is liable for the tax,” which “attaches when the title to the article sold passes from the manufacturer to the buyer.” However, an exemption applies for sale or resale “for export … to a foreign country.” See also Internal Revenue Service, Publication 510: Excise Taxes (rev. Mar. 2018), available at http://www.irs.gov/publications/p510. Manufacturers do not pay the excise tax on vaccines exported for use outside of the United States, suggesting that claims for those vaccines should not be liberally accepted. 13 While the legislative history addresses primarily programs and laws requiring vaccination of children, states also require vaccination of certain adults such as employees in healthcare facilities in the United States. See Centers for Disease Control and Prevention, Vaccination Laws, available at https://www.cdc.gov/phlp/publications/topic/vaccinationlaws.html (last accessed April 12, 2019). 14 See e.g., Oxford Dictionary, https://en.oxforddictionaries.com/definition/humanitarian (humanitarian (adj.): “concerned with or seeking to promote human welfare… denoting an event or situation which causes or involves widespread human suffering, especially one which requires the large-scale provision of aid’); Oxford Advanced Learner’s Dictionary at https://www.oxfordlearnersdictionaries.com/us/definition/english/humanitarian 2 (“concerned with reducing suffering and improving the conditions that people live in”). 10 Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 11 of 13 and it is doubtful that the United States or any state or local government would have authority to impose vaccination requirements outside of its own borders (with the exception of persons applying to immigrate to the United States). Petitioners also argue that this “humanitarian” purpose would also be served by allowing claims by “repeat visitors” to the United States, particularly those reentering the United States for medical treatment because “a Program award lessens the financial burden on the vaccine- injure person and their family.” Pet. Resp. at 7. It is true that the Program compensates eligible petitioners for unreimbursed expenses. However, a not insignificant number of people come from other countries to the United States for more sophisticated medical care, as in this case. See Pet. Ex. 5 at 7 (recommending that A.R.D-C. be transferred from a hospital in The Bahamas to another institution that was better equipped to diagnose and treat his condition). There is no indication that Congress would permit compensation to persons coming to the United States for medical treatment, but only if they had entered this country prior to vaccination and returned within six months. Related to this same goal, petitioners argue that allowing claims by “repeat visitors” who seek treatment in the United States “also lessens the financial burden on [the] healthcare provider[s]” therein. Pet. Resp. at 7-8. However, this argument is unavailing because for the majority of healthcare services, the providers are not paid by individuals, but by private insurance companies as well as federal and state health benefits programs. The Vaccine Program is a secondary payer of medical expenses. It is not subject to liens from private insurance carriers or federal medical insurance programs such as Medicare – but only subject to liens from state Medicaid programs. § 300aa-15(g) – (h). In addition to the goals of stabilizing the vaccine market and compensating for post- vaccination injuries, Congress also recognized that the federal government has historically had the “responsibility to prevent the spread of infectious diseases from other countries into the United States and between States within its own borders.” H.R. Rep. 99-908 at 5; see also Griffin v. Sec’y of Health & Human Servs., No. 13-280V, 2013 WL 1653427, *7 (Fed. Cl. Spec. Mstr. April 4, 2014) (connecting this goal to the Vaccine Act’s provisions making eligible United States citizens who are vaccinated while serving abroad in the military or otherwise employed by the United States, and the provision regarding persons receiving vaccinations and then “return[ing]” within six months), mot. for rev. denied, 124 Fed. Cl. 101 (2014), aff’d, 602 Fed. App’x 528 (Fed. Cir. 2015). Petitioners argue that “repeat visitor[s]” present a “special risk” of bringing infectious diseases from foreign countries to the United States and making them eligible for this program would encourage them to get vaccinated. Pet. Resp. at 9. However, any visitor who is not vaccinated might potentially spread infectious disease, on either a first or repeat entry into the United States. It is illogical to suggest that Congress recognized this issue but decided to tolerate first-time entries by unvaccinated visitors but encourage vaccination for repeat visitors.15 15 Outside of the Vaccine Act, Congress actually draws a distinction between foreign nationals entering the United States permanently versus temporarily. In 1996, Congress amended the Immigration and Nationality Act to provide that foreign nationals applying for immigrant visas abroad or seeking to adjust to permanent residency status while in the United States are required to provide proof of vaccinations recommended for the general United States population by the Secretary of Health and Human Services. Failure to provide this proof is cause for exclusion from 11 Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 12 of 13 The statutory language at issue in this case is admittedly puzzling and is not explained in the legislative history. In my view, it most reasonably can be read to address persons who reside in the United States, who receive vaccinations while living or working abroad, and then return within six months. Such persons might receive the vaccinations with knowledge of the United States’ public health initiatives and laws regarding vaccination. Congress’s use of the word “person” rather than “citizen” in this section (and throughout the Vaccine Act generally) evinces an intent to liberally include persons who are expected to be present in the United States apart from a temporary absence and to benefit domestic public health.16 In this case, there is no evidence of intent for A.R.D-C. to live in the United States. His paternal grandmother, father, and mother’s established primary place of residence was in The Bahamas. While the paternal grandmother owned a residential property in the United States, that was only a destination for periodic “visits.” Pet. Exs. 10, 16. Petitioners aver that A.R.D- C., as well, would “likely… have been a frequent visitor to the United States had he not died as a result of his vaccine-related illnesses.” Pet. Resp. at 12. While this may be true, A.R.D-C.’s entire first year of life was spent in The Bahamas and there is little doubt that the family was domiciled there. He received the vaccines at issue as part of his pediatric care in The Bahamas, and not related to any visa application or other vaccination program administered by the United States. While he was only a year old when he received the vaccines at issue and he was his parents’ first child, the record does not suggest that they were applying for daycare or school in the United States. Additionally, when A.R.D-C. was issued a temporary visa for the first time, it did not require proof of vaccination. That visa was to enter the United States in order to obtain more sophisticated medical treatment. Additionally, that entry was never intended to be permanent. The parents expressed a desire to go “home” to The Bahamas. See Pet. Ex. 10 ¶¶ 18-19 (the mother’s recollection that they were not permitted to “trave[l] back home to The Bahamas,” until they were “finally given permission to leave the USA… provided [they] come back to Miami Children’s Hospital for monthly visits”); Pet. Mot. Mem. at 3 (stating that A.R.D-C. was only able to “return briefly to The Bahamas” two times before he passed away in the United States). Thus, his entry to the admission into the United States. 8 U.S.C. § 1182(a)(1)(A)(ii) (as amended Sept. 30, 1996); see also U.S. Citizenship and Immigration Services, Vaccination Requirements, https://www.uscis.gov/news/questions-and- answers/vaccination-requirements (last accessed April 19, 2019); U.S. Department of State, Vaccinations – Important Notice to Immigrant Visa Applicants Concerning Vaccination Requirements, https://travel.state.gov/content/travel/en/us-visas/immigrate/vaccinations.html (last accessed April 19, 2019). In contrast, foreign nationals visiting the United States temporarily for business or pleasure are excluded from the definition of “immigrant” and not subject to these vaccination requirements. 8 U.S.C. § 1101(a)(15)(B). Such persons apply instead for non-permanent visas for business (B-1), pleasure (B-2), or a combination of both (B-1/B- 2). “Pleasure” is defined as “legitimate activities of a recreational character including tourism, amusement, visits with friends or relatives, rest, medical treatment, and activities of a fraternal, social, or service nature.” 22 C.F.R. § 41.31(b)(1) (2006) (emphasis added). In this case, A.R.D-C. was issued a B-1/B-2 visa to enter the United States for the first time on January 12, 2017, shortly before entering the United States for more advanced medical treatment. Pet. Ex. 11 at 5. 16 But see 42 U.S.C. § 300aa-11(c)(1)(B)(II) (permitting a claim for a vaccine received abroad by a United States “citizen” while serving in the Armed Forces or otherwise employed by the United States, without a return requirement). 12 Case 1:17-vv-01551-RAH Document 29 Filed 05/28/19 Page 13 of 13 United States for medical treatment, although it was effectively permanent, cannot be construed as a “return.” III. CONCLUSION I express my deep personal sympathy and condolences to this family for the tragic loss of their child, regardless of possible causation by the vaccines he received. However, they are not eligible to seek compensation from the Vaccine Program. First, A.R.D-C. cannot be viewed to be a “person” who was present in the United States prior to his vaccinations. Second, even if A.R.D-C. was viewed to be a person upon being carried in utero into the United States, there is not sufficient evidence that he would have “returned” within six months, as that word is construed to mean under the Vaccine Act, apart from the need for more sophisticated medical care that was not available in his home country of The Bahamas. While A.R.D-C. may have temporarily visited the United States, like his parents, there is no evidence that he would have established a permanent presence in this country. Interpreting “return” more broadly to encompass this claim would run too far afield of Congress’s intent to create a “national” program. Accordingly, the petition must be DISMISSED. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court shall enter judgment in accordance herewith.17 IT IS SO ORDERED. s/Thomas L. Gowen Thomas L. Gowen Special Master 17 Entry of judgment is expedited by each party’s filing notice renouncing the right to seek review. Vaccine Rule 11(a). 13 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_17-vv-01551-1 Date issued/filed: 2019-09-25 Pages: 10 Docket text: JUDGE VACCINE REPORTED OPINION re: 40 MEMORANDUM OPINION Signed by Judge Richard A. Hertling. (abg) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-01551-RAH Document 43 Filed 09/25/19 Page 1 of 10 In the United States Court of Federal Claims No. 17-1551V (Filed Under Seal: September 10, 2019) (Reissued for Public Availability: September 25, 2019)1 ) ROBERT DAVID DUPUCH-CARRON ) and ELIZABETH JOANNA CARRON, ) as the legal representatives of their ) minor son, A.R. D-C., ) ) Statutory interpretation; National Vaccine Petitioners ) Injury Compensation Act, 42 U.S.C. ) §§300aa-1 et seq.; the Vaccine Act; 42 v. ) U.S.C. § 300aa-11(c)(1)(B)(i); Return ) SECRETARY OF HEALTH AND ) HUMAN SERVICES, ) ) Respondent. ) ) Curtis R. Webb, Twin Falls, ID, for petitioners. Lisa Ann Watts, Torts Branch, Civil Division, United States Department of Justice, Washington, DC, for respondent. MEMORANDUM OPINION HERTLING, Judge The petitioners, Robert David Dupuch-Carron and Elizabeth Joanna Carron, husband and wife, are the legal representatives of the estate of their deceased son, A.R. D-C. They filed this action seeking compensation for injuries allegedly compensable under the National Vaccine Injury Compensation Act, 42 U.S.C. §§ 300aa-1 et seq. (“the Vaccine Act”). On the parties’ cross-motions for summary judgment, the Special Master ruled that the petitioners are ineligible to receive compensation under the Vaccine Act, granted the respondent’s motion, and dismissed the petition. See Dupuch-Carron v. Sec’y of Health & Human Servs., 2019 WL 22663369 (“Dupuch-Carron”). The petitioners filed this motion for review pursuant to 42 U.S.C. § 300aa- 12(e). 1 Pursuant to Vaccine Rule 18(b), this opinion was initially filed on September 10, 2019, and the parties were afforded 14 days to propose redactions. The parties did not propose any redactions. Accordingly, this opinion is reissued in its original form for posting on the Court’s website. Case 1:17-vv-01551-RAH Document 43 Filed 09/25/19 Page 2 of 10 I. Facts A brief recitation of the facts provides necessary context.2 The petitioners were domiciled in Nassau, The Bahamas, for the entirety of the time period relevant to this case. Ms. Carron is a citizen of the United Kingdom and avers that she is a “frequent visitor to the United States,” spending “10 to 12 long weekends” in the country each year. During a trip to Coral Gables, Florida from March 24 to April 3, 2015, Ms. Carron visited an internist, who informed her that she was pregnant. After learning she was pregnant with A.R. D-C, she claims to have traveled to the United States an additional four times over the course of her pregnancy. Mr. Dupuch-Carron was born in the United States. His citizenship is not noted in the record. He appears to have grown up in The Bahamas but recalls “spen[ding] a great deal of time [in the United States] as a child during the summer holidays.” Mr. Dupuch-Carron avers that he is a “frequent visitor to the United States,” spending “between 30 and 45 days in the United States on business” in a typical year. A.R. D-C was born on November 24, 2015, at Doctors Hospital in Nassau, The Bahamas. He continued to live in Nassau for the first six months of his life. During his first six months, A.R. D-C had unremarkable well-child visits at Precious Posterity Pediatric Centre in Nassau, and was considered to be healthy and developing normally. He also received his first two sets of vaccinations in Nassau, apparently with no adverse consequences. On June 23, 2016, during his six-month well-child visit to his pediatrician in Nassau, A.R. D-C received his third set of vaccinations, which included the DTap, IPV, HIB, HBV, Prevnar, and rotavirus vaccinations. There is no dispute that the eight vaccines A.R. D-C received during his June 23rd visit to the pediatrician are listed in the Vaccine Injury Table and were manufactured by companies with a presence in the United States. On July 7, 2016 and July 9, 2019, A.R. D-C presented at the pediatrician with complaints of a fever greater that 102 degrees Fahrenheit, crankiness, stuffy nose, rattling in his chest, occasional chesty coughs, reduced activity, vomiting, and diarrhea. On July 10, 2016, A.R. D- C’s parents brought him to the emergency room at Doctors Hospital in Nassau with complaints of fever and vomiting for five days, irritability, and decreased appetite. The doctors determined he had thrombocytopenia3 and pancytopenia4 for which he received a blood transfusion, and 2 Because the Special Master granted summary judgment, he necessarily determined that no material facts were in dispute. As the undisputed facts have not changed, the Court’s recitation of the background facts herein draws from the Special Master’s opinion in Dupuch-Carron. 3 Thrombocytopenia is defined as a “decrease in the number of platelets.” Dorland’s Illustrated Medical Dictionary 1069 (32nd ed. 2012) (“Dorland’s”) at 1922. 4 Pancytopenia is defined as a “deficiency of all cellular elements of the blood.” Dorland’s at 1368. 2 Case 1:17-vv-01551-RAH Document 43 Filed 09/25/19 Page 3 of 10 febrile neutropenia5 for which he was given an intravenous antibiotic. On July 11, 2016, A.R. D-C was transferred to the intensive care unit at Princess Margaret Hospital in Nassau, where a pediatric hematologist–oncologist recommended he be transferred to an institution “equipped to enable quick turn around and confirmation of the leukemia if present.”6 Physicians in The Bahamas determined that A.R. D-C would receive better treatment in the United States, and on July 13, 2016, A.R. D-C was transferred by air ambulance to Nicklaus Children’s Hospital in Miami, Florida, where he was diagnosed with hemophagocytic lymphohistiocytosis (“HLH”).7 HLH is an autoimmune disease of the blood, fatal unless treated successfully. A.R. D-C was treated at Nicklaus Children’s Hospital until he was discharged on August 12, 2016, “on the condition he remain in Florida as an outpatient.” A.R. D-C continued weekly treatment with Dr. Maggie Fader as an outpatient at Nicklaus Children’s Hospital. A.R. D-C was cleared to leave the United States over the Christmas season, so the family returned to The Bahamas. On February 28, 2017, A.R. D-C was readmitted to Nicklaus Children’s Hospital. He was diagnosed with acute myeloid leukemia (“AML”).8 A.R. D-C underwent treatment, which included chemotherapy9 and radiation10 at Cincinnati Children’s Hospital in Cincinnati, Ohio, as well as a bone-marrow transplant at Johns Hopkins Bloomberg Children’s Hospital in Baltimore, Maryland. On October 17, 2017, the petitioners filed a claim under the Vaccine Act. On December 24, 2017, A.R. D-C died from AML, and on March 26, 2018, the petitioners filed an amended petition, alleging that the AML, which caused A.R. D-C’s death, was a complication resulting from the treatment he had received for his vaccine-induced HLH. II. Procedural History Prior to the filing of the amended petition, the Special Master had identified as a threshold question the issue of whether the petitioners were eligible for compensation under the Vaccine Act because the vaccines were administered outside of the United States. The Special Master directed the parties to file cross-motions for summary judgment on that limited issue. 5 Neutropenia is “an abnormal decrease in the number of neutrophils in the blood, with the absolute neutrophil count being less than 1500/μL.” Dorland’s at 1272. 6 Leukemia is “a progressive, malignant disease of the blood-forming organs, characterized by distorted proliferation and development of leukocytes and their precursors in the blood and bone marrow.” Dorland’s at 1026. 7 Hemophagocytic lymphohistiocytosis is “any of several closely related disorders involving both lymphocytosis and histiocytosis, with excessive hemophagocytosis in the lymphoreticular system or the central nervous system.” Dorland’s at 1085. 8 Acute myeloid leukemia, also known as acute myeloblastic leukemia or acute myelogenous leukemia, is “a common kind of acute myelogenous leukemia, in which myeloblasts predominate.” Dorland’s at 1026. 9 Chemotherapy is “the treatment of a disease by chemical agents.” Dorland’s at 341. 10 Radiation is “energy transmitted by waves through space or through some medium; usually referring to electromagnetic radiation when used without a modifier.” Dorland’s at 1570. 3 Case 1:17-vv-01551-RAH Document 43 Filed 09/25/19 Page 4 of 10 On March 26, 2018, concurrent with their filing of the amended petition, the petitioners filed their Motion for Partial Summary Judgment on the limited issue of their eligibility under the Vaccine Act for compensation. On June 7, 2018, the respondent filed its Cross–Motion for Summary Judgment on that threshold issue. Petitioners filed their Response and Reply on July 12, 2018. On April 23, 2019, the Special Master denied the petitioners’ Motion and granted the respondent’s. On May 23, 2019, the petitioners filed a Motion for Review of the Special Master’s decision, asking this Court to review and reverse the Special Master’s decision. In their Motion for Review, the petitioners raise the following single numbered objection: The special master’s conclusion that the petitioners were not eligible to seek compensation from the National Vaccine Injury Compensation Program because their son [A.R. D-C]: 1) could not be viewed as a person who was present in the United States prior to his vaccinations; and 2) had not returned to the United States within six months after vaccinations was not in accordance with the law. The respondent filed its Response to the petitioners’ Motion for Review on June 20, 2019, arguing that the Special Master’s decision on the petitioners’ eligibility to seek compensation under the Vaccine Act was correct. With the Court’s leave, the petitioners filed their Reply on July 5, 2019. The Court heard oral argument on the petitioners’ Motion for Review on September 5, 2019. III. Standard of Review Under the Vaccine Act, this Court may review a Special Master’s decision upon the timely request of either party. See 42 U.S.C. § 300aa-12(e)(1)-(2). The Court may: “(A) uphold the findings of fact and conclusions of law . . . , (B) set aside any findings of fact or conclusion of law . . . found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law . . . , or, (C) remand the petition to the special master for further action in accordance with the court’s direction.” Id. § 300aa-12(e)(2)(A)-(C). Findings of fact and discretionary rulings are reviewed under an “arbitrary and capricious” standard, while legal conclusions are reviewed de novo. Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992); see also Doyle ex rel. Doyle v. Sec’y of Health & Human Servs., 92 Fed. Cl. 1, 5, n.8 (2010). The sole issue in this case is whether the petitioners, who are not domiciled in the United States, and whose son received the allegedly injurious vaccines outside of the United States, are eligible to bring a claim under the Vaccine Act. This question requires the Court to interpret the relevant provisions of the Vaccine Act. As a question of law, an issue of statutory interpretation is subject to de novo review. Black v. Sec’y of Health & Human Servs., 33 Fed. Cl. 546, 549 (1995) (collecting cases). 4 Case 1:17-vv-01551-RAH Document 43 Filed 09/25/19 Page 5 of 10 IV. Discussion A. Relevant Statutory Provisions The Vaccine Act, 42 U.S.C. § 300aa-11(c)(1)(B)(i), delimits the categories of persons who may pursue a claim under it. Pursuant to the relevant provision, the party seeking compensation under the Act must show that he: (I) received the vaccine in the United States or in its trust territories; (II) received the vaccine outside the United States or a trust territory and at the time of the vaccination such person was a citizen of the United States serving abroad as a member of the Armed Forces or otherwise as an employee of the United States or a dependent of such a citizen; or (III) received the vaccine outside of the United States or a trust territory and the vaccine was manufactured by a vaccine manufacturer located in the United States and such person returned to the United States not later than 6 months after the date of the vaccination. Id. (emphasis added). The petitioners do not claim that either 42 U.S.C. § 300aa-11(c)(1)(B)(i)(I) or § 300aa- 11(c)(1)(B)(i)(II) is applicable to this case. Therefore, the question before the Court is whether 42 U.S.C. § 300aa-11(c)(1)(B)(i)(III) allows the petitioner, under the specific facts of this case, to receive compensation under the Vaccine Act. B. The McGowan Decision McGowan v. Secretary of the Department of Health & Human Services is the only relevant judicial precedent. 31 Fed. Cl. 734 (1994). In McGowan, the petitioner, who was born in the United States, received two vaccinations in Canada, where she resided and where her father was receiving medical training. Id. at 736. Within six months of her August 20, 1965 vaccination, the petitioner entered the United States to visit her maternal grandparents. Id. She received her second vaccine in Canada in late December 1965. Id. In April 1967, the petitioner and her parents returned permanently to the United States. Id. On October 1, 1990, the petitioner filed an application for compensation under the Vaccine Act, arguing that she suffered encephalopathy as a result of her August 20, 1965 measles vaccine.11 Id. The Special Master dismissed the petitioner’s claim, finding that she had failed to prove, by a preponderance of the evidence, that she had returned to the United States within six months of her August 20, 1965 measles vaccination. Id. On review, this Court sustained the Special Master’s decision, holding that the “petitioner has failed to ‘return’ within the meaning of 42 U.S.C. § 300aa–11(c)(1)(B)(i)(III) and fails to meet the jurisdictional requirements of the Vaccine Act.” Id. at 740. 11 Encephalopathy is defined as “any degenerative disease of the brain.” Dorland’s at 614. 5 Case 1:17-vv-01551-RAH Document 43 Filed 09/25/19 Page 6 of 10 Just as in this case, the decisive issue in McGowan was the meaning of the word “return” in the relevant provision of the Vaccine Act. 31 Fed. Cl. at 738. As framed by the Court, the question “regarding the definition of ‘return’ is whether there is a sense of permanence inherent in the word.” Id. There, as here, the “[p]etitoner argue[d] that a return is completed with the initial entry,” while the respondent contended that “a ‘return’ requires at least an intention to remain, from that moment on, as a permanent resident of the United States.” Id. The McGowan Court found that the simple dictionary definitions of “return” “shed little light on the issue.” Id. Instead, the Court canvassed the legislative history of the Vaccine Act to determine the legislative purpose behind its enactment. The Court identified two goals underlying the Act’s implementation. The first was “to ‘offer fair compensation to victims’ injured in connection with childhood vaccination programs[.]” Id. (quoting H.R. 1780, 99th Cong., 1st Sess. (1985); S. 827. 99th Cong., 1st Sess. (1985); H.R. Rep. No. 99-908 pt. 1 at 7 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6367). The second was “to insure the ‘continued supply of vaccines that are vital to the public health.’” Id. at 739 (quoting same). In interpreting 42 U.S.C. § 300aa-11(c)(1)(B)(i)(III), the McGowan Court held “[a]n injured person who does not intend to return to live in the United States should not be able to petition for a claim.” 31 Fed. Cl. at 739. The Court further held that “[t]o rule that ‘return’ means simply to physically enter the United States is to invite absurd scenarios.” Id. (citing Hellebrand v. Sec’y of Dep’t of Health & Human Servs., 999 F.2d 1565, 1570–71 (Fed. Cir. 1993)) (“[A] court should seek to avoid construing a statute in a way which yields an absurd result and should try to construe a statute in a way which is consistent with the intent of Congress.”). Ultimately, the Court held that “[a]s Congress meant that ‘return’ would mean a permanent return, an injured person must return to the United States within six months of the vaccination date, with the intention to remain permanently from that point on, in order to be able to participate in the compensation program.” Id. at 740. C. Analysis The crux of the petitioners’ claim at this stage of the case centers on whether A.R. D-C “returned” to the United States within six months of his receipt of the vaccine, pursuant to 42 U.S.C. § 300aa-11(c)(1)(B)(i)(III).12 The petitioners argue that the Special Master inappropriately interpreted the word “return” because “[t]he relevant language of the Vaccine 12 The petitioners also raise the argument that a child in utero is a “person” for the purposes of the Vaccine Act. The Vaccine Act considers a child whose mother receives a vaccine while the child is in utero to be a “person” for the purposes of the Vaccine Act. 42 U.S.C. § 300aa- 11(f)(1) (“[F]or the purposes of this subpart, both a woman who received a covered vaccine while pregnant and any child who was in utero at the time such a woman received the vaccine shall be considered persons to whom the covered vaccine was administered and persons who received the covered vaccine.”). While the Court need not decide the question, it assumes, for the purposes of its analysis, that A.R. D-C was a “person” under the relevant portions of the Vaccine Act, with a prior presence in the United States. The sole issue requiring analysis to resolve the case is whether A.R. D-C’s arrival in Miami for medical treatment constituted a “return” to the United States within six months of his vaccination. 6 Case 1:17-vv-01551-RAH Document 43 Filed 09/25/19 Page 7 of 10 Act is not ambiguous,” and the Special Master’s interpretation of “return” does not comport with the “ordinary meaning” of the word. In making that argument, the petitioners point to the Oxford English Dictionary, which defines “return” as “to come or go back to a place or person.” Id.; see also Return, OXFORD ENGLISH DICTIONARY (2d ed. 1989). The petitioners contend that failing to apply the “ordinary meaning” of the word is “clearly inconsistent with the Supreme Court’s unanimous holding in Sebelius v. Cloer.” See Sebelius v. Cloer, 569 U.S. 369, 376–77 (2013) (“As in any statutory construction case, this Court proceeds from the understanding that ‘[u]nless otherwise defined, statutory terms are generally interpreted in accordance with their ordinary meaning.’”) (quoting BP America Production Co. v. Burton, 549 U.S. 84, 91 (2006)). Therefore, the petitioners argue, under the plain meaning of the unambiguously used definition of “return,” they should be allowed to maintain their claim. The respondent rejects the petitioners’ interpretation of “return,” instead arguing that, under the Vaccine Act, as construed in McGowan, 31 Fed. Cl. at 740, “return” does not mean a temporary visit, but an arrival “with the intention to remain permanently from that point on.” The respondent relies on the Court’s decision in McGowan in making that argument.13 While the respondent does not reject the petitioners’ understanding of the “plain meaning” of “return,” the respondent argues that, to qualify for Vaccine Act compensation, a “return” necessarily requires a sense of permanence. Because the word ‘return’ relies on its context in order to impart a sense of permanence, the respondent argues, the plain meaning rule is not dispositive. Thus, this case turns on whether A.R. D-C’s arrival for medical treatment constitutes “return” for the purposes of the act’s exception to its requirement that claimants be vaccinated in the United States. As in any case involving statutory interpretation, the Court’s analysis must begin with the words employed by the legislature. See, e.g., Lewis v. United States, 445 U.S. 55, 60 (1980) (“[I]n any case concerning the interpretation of a statute the ‘starting point’ must be the language of the statute itself.”); see also Reiter v. Sonotone Corp., 442 U.S. 330, 337 (1979) (“As is true in every case involving the construction of a statute, our starting point must be the language employed by Congress.”). Such an inquiry requires that the Court analyze the legislature’s words in accordance with both their ordinary meaning and within the context of the statutory scheme surrounding their implementation. No single word or phrase should be wrenched from 13 The respondent also argues that, because A.R. D-C was born in The Bahamas and never lived in the United States after birth, he could not “return” to the United States. Thus, the respondent posits that A.R. D-C’s first entry into the United States occurred on July 13, 2016, when he arrived for medical treatment. The respondent similarly rejects the petitioners’ argument that A.R. D-C’s mother’s occasional visits during her pregnancy were sufficient to establish that he was “present” in the United States for the purpose of the Vaccine Act. While these arguments were raised by the respondent, the Court does not believe it necessary to address whether A.R. D-C’s in utero visits constituted presence in the United States, because such a determination would, in and of itself, not be dispositive of the case. Instead, the Court’s decision turns on whether A.R. D-C’s arrival in the country for medical treatment constituted a “return” sufficient to satisfy the Vaccine Act, assume the in utero visits were A.R. D-C’s initial entries into the country. 7 Case 1:17-vv-01551-RAH Document 43 Filed 09/25/19 Page 8 of 10 its context and interpreted in a vacuum. See Houlihan v. Sec’y of Health & Human Servs., 45 Fed. Cl. 201, 205 (1999) (“A statute is to be read as an undivided whole, not a collection of disparate clauses.”). To do so would defeat the purpose of the judicial enterprise, which is to interpret the law applicable to a particular case in accordance with what the legislature wrote as a whole. As to the ordinary meaning of “return,” this Court agrees with McGowan that dictionary definitions of the word shed little light on what the word means in the Vaccine Act. See 31 Fed. Cl. at 738. While this Court does not necessarily agree with McGowan that a “return” must be permanent, id. at 740, this Court recognizes that applying the broadest meaning to the term as argued by the petitioners invites absurd results inconsistent with the statute’s context. See id. at 739. For instance, if a French citizen, resident in France, vacationed in the United States, then returned to France and received a vaccination there, the fact that one week later, the French citizen stopped in New York to change planes on his way to Mexico would permit him to submit a Vaccine Act claim under the petitioners’ broad reading of “return.” It is inconceivable that Congress’s use of the term “return” in the Act was meant to extend the benefits of the Vaccine Injury Compensation Program to this scenario. That application produces an absurd result even if “return” might ordinarily be used this way in other contexts. See United States v. Kirby, 74 U.S. 482, 486-87 (1868) (“All laws should receive a sensible construction. General terms should be so limited in their application as not to lead to injustice, oppression, or an absurd consequence.”). What counts as a “return” for the Vaccine Act must have some limit, but the term’s range of ordinary meanings requires the Court to look to context for further clues. The context surrounding the term “return” suggests that “return” means something more than a nonresident prior visitor’s temporary entry for medical treatment. The term is used in a gatekeeping provision that waives the government’s sovereign immunity, and without any explicit language calling for the Vaccine Act’s extraterritorial application. First, the Federal Circuit has described the section containing the statutory provision at issue, 42 U.S.C. § 300aa-11, as a “gate-keeping” provision, which a petitioner must satisfy to maintain a Vaccine Act claim. Amendola v. Sec’y of Dep’t of Health & Human Servs., 989 F. 2d 1180, 1182 (Fed. Cir. 1993). Indeed, 42 U.S.C. § § 300aa-11(c)(l)(B)(i)(III), operates as a limitation on coverage. Second, the Vaccine Act operates as a limited waiver of sovereign immunity. Therefore, its provisions must be given a “strict and narrow construction.” Houlihan, 45 Fed. Cl. at 207; see also Grice v Sec’y of Health & Human Servs., 36 Fed. Cl. 114, 120 (1996) (“[T]he Vaccine Act is a limited waiver of sovereign immunity.”). Moreover, when Congress waives sovereign immunity, any ambiguities in the statute must be resolved in favor of the federal government as the sovereign. Houlihan, 45 Fed. Cl. at 208. Thus, it would be inconsistent with the purpose of 42 U.S.C. § § 300aa-11(c)(l)(B)(i)(III) to accept the petitioners’ unlimited reading of “return,” expanding the Vaccine Act’s waiver of sovereign immunity to claims from individuals with no or few meaningful ties to the United States. 8 Case 1:17-vv-01551-RAH Document 43 Filed 09/25/19 Page 9 of 10 Third, there is no indication in the statute that Congress intended to apply the Vaccine Act outside of the United States.14 Unless Congress is explicit in seeking to extend the extraterritorial effect of a legislative act, the presumption must be that a statute only has domestic application. Kiobel v. Royal Dutch Petroleum Co., 569 U.S. 108, 115 (2013); Morrison v. National Bank of Australia, Ltd., 561 U.S. 247, 255 (2010); Microsoft Corp. v. AT&T Corp., 580 U.S. 437, 454 (2007); E.E.O.C. v. Arabian Am. Oil Co., 499 U.S. 244, 248 (1991).15 The Court has canvassed the entire statutory text and legislative history of the Vaccine Act. There is not a single hint that Congress was thinking about compensating individuals vaccinated outside of the United States who lacked ties to the country. Moreover, the Vaccine Injury Compensation Program’s funding structure, set out in the Vaccine Act, also suggests that Congress did not explicitly seek for the Act to have extraterritorial application. Congress funded the Vaccine Program through an excise tax of seventy-five cents ($0.75) per sale of a taxable vaccine that is manufactured or produced in the United States, or enters the United States “for consumption, use, or warehousing.” 26 U.S.C. §§ 4132, 4131(a)(1). Vaccines sold or re-sold “for export . . . to a foreign country” are exempt from the tax. See INTERNAL REVENUE SERV., Pub. 510: Excise Taxes (rev. Mar. 2018; last visited Sept. 5, 2019) http://www.irs.gov/publications/p510. Thus, the Vaccine Injury Compensation Program is funded by excise taxes on domestic manufacturers and producers, suggesting that Congress intended to limit that Program to domestic claims, with limited exceptions. Here again, an expansive definition of “return” could work against one of the key goals underlying the Vaccine Act, ensuring the supply of vaccines, by expanding the potential class of beneficiaries without adequate financial support for the program. In sum, the term “return” must be limited by its context to avoid absurd results. The Act’s waiver of sovereign immunity is strictly and narrowly construed—a principle with which the Court must assume Congress was familiar when it enacted the Vaccine Act. Nothing in the Act or its legislative history overcomes the presumption against extraterritoriality, and the coverage-expanding results of the petitioners’ interpretation are inconsistent with the Act’s funding and coverage-limiting provisions. The petitioners’ unlimited reading of the word “return” must be rejected. Because of the quality of medical care available in this country, foreign nationals from countries with fewer medical resources often avail themselves of advanced or specialized treatment in the United States. Congress would have been familiar with this phenomenon.16 14 The Vaccine Act makes clear that it covers vaccines provided in the United States, and vaccines administered abroad to United States citizens. 42 U.S.C. § 300aa-11(c)(1)(B)(i)(I), (II). This context in which Congress actually restricted the remedies in the Vaccine Act to some Americans receiving vaccines abroad supports the inference that Congress had in mind United States persons as it thought about the potential beneficiaries of the Vaccine Act. 15 Kiobel, for example, applied the presumption against extraterritorial effect to a statute enacted in 1789; a fortiori the presumption also applies to a statute enacted in 1986. 16 For example, several years before Congress considered the Vaccine Act, the former Shah of Iran sought medical treatment in the United States, triggering strong reactions in Iran, including the seizure of the U.S. Embassy and the taking of hostages. 9 Case 1:17-vv-01551-RAH Document 43 Filed 09/25/19 Page 10 of 10 In light of the silence in the legislative record and the presumptions attendant to the task of statutory interpretation in this case, the Court finds nothing to suggest that Congress meant to cover foreign nationals arriving in the United States for the purpose of seeking medical treatment when it used the word “return” in the Vaccine Act. This holding is narrower than the rule adopted in McGowan. The Court declines to adopt the reading of the statute advanced by the respondent, in reliance on McGowan, that “return” must include an intent to establish permanent residence in the United States because it is broader than necessary to resolve this case. V. Conclusion Because A.R. D-C’s entry into the United States to receive medical treatment did not fall within the more specific meaning of “return to the United States” that the Vaccine Act’s broader context demands, he has therefore not satisfied the requirements under 42 U.S.C. § 300aa- 11(c)(l)(B)(i)(III). The Court has no choice but to deny the petitioners’ Motion for Review. s/ Richard A. Hertling Richard A. Hertling Judge 10