Court Opinion

ID: 9960107
Source: CourtListenerOpinion
Date Created: 2024-04-15 14:01:35.110421+00
Date Added: 2024-06-11T08:19:11.291902
License: Public Domain

Case: 23-1032   Document: 45     Page: 1   Filed: 04/15/2024

   United States Court of Appeals
       for the Federal Circuit
                 ______________________

   VICTORIA LEMING, KEVIN LEMING, PARENTS
   AND NATURAL GUARDIANS OF A.L., A MINOR,
              Petitioners-Appellants

                            v.

    SECRETARY OF HEALTH AND HUMAN SER-
                   VICES,
              Respondent-Appellee
            ______________________

                       2023-1032
                 ______________________

     Appeal from the United States Court of Federal Claims
 in No. 1:18-vv-00232-EDK, Chief Judge Elaine Kaplan.
                  ______________________

                 Decided: April 15, 2024
                 ______________________

    ROBERT JOEL KRAKOW, I, Law Office of Robert J. Kra-
 kow, New York, NY, argued for petitioners-appellants.

     JULIA COLLISON, Torts Branch, Civil Division, United
 States Department of Justice, Washington, DC, argued for
 respondent-appellee. Also represented by ALEXIS B. BAB-
 COCK, BRIAN M. BOYNTON, C. SALVATORE D'ALESSIO,
 HEATHER LYNN PEARLMAN.
                 ______________________
Case: 23-1032      Document: 45      Page: 2    Filed: 04/15/2024

 2                                                LEMING v. HHS

     Before MOORE, Chief Judge, STOLL, Circuit Judge, and
               BENCIVENGO, District Judge. 1
 BENCIVENGO, District Judge
     A.L., the daughter of Petitioners-Appellants Victoria
 and Kevin Leming, experienced immune thrombocytopenic
 purpura after receiving the DTaP, Hib, and MMR vaccines.
 As a result of her vaccine injury, she was hospitalized for
 two weeks and underwent a bone marrow aspiration and
 biopsy. The Court of Federal Claims held that the Lemings
 could not establish by a preponderance of the evidence that
 A.L. satisfied the “surgical intervention” severity require-
 ment of 42 U.S.C. § 300aa-11(c)(1)(D)(iii). Because the
 court below relied upon a legally erroneous construction of
 “surgical intervention,” we reverse and remand.
                          BACKGROUND
                                A
      In 1986, the National Childhood Vaccine Injury Act
 (the “Vaccine Act”) was enacted to provide compensation to
 vaccine recipients who suffered from injury or death caused
 by a vaccine. See Pub. L. No. 99-660, § 311, 100 Stat. 3743,
 3755-84 (codified as amended at 42 U.S.C. §§ 300aa-1 to -
 34).
     The Vaccine Act initially restricted recovery to only
 those recipients who:
      (i) suffered the residual effects or complications of
      such illness, disability, injury, or condition for more
      than 1 year after the administration of the vaccine,
      (ii) incurred unreimbursable expenses due in whole
      or in part to such illness, disability, injury, or

      1  Honorable Cathy Ann Bencivengo, District Judge,
 United States District Court for the Southern District of
 California, sitting by designation.
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 LEMING v. HHS                                                 3

     condition in an amount greater than $1,000, or (iii)
     died from the administration of the vaccine[.]
 Id. § 311, 100 Stat. at 3761.
     In 2000, however, this “severity requirement” was
 amended by the Children’s Health Act, Pub. L. No. 106-
 310, 114 Stat. 1101, to require Vaccine Act petitioners
 prove that the recipient:
     (i)   suffered the residual effects or complications
           of such illness, disability, injury, or condition
           for more than 6 months after the admin-
           istration of the vaccine, or (ii) died from the
           administration of the vaccine, or (iii) suf-
           fered such illness, disability, injury, or con-
           dition from the vaccine which resulted in
           inpatient hospitalization and surgical inter-
           vention[.]
 42 U.S.C. § 300aa-11(c)(1)(D) (emphasis added).
 The burden is on a petitioner to prove that one of these re-
 quirements is met by a preponderance of the evidence.
                                 B
     On September 6, 2016, Appellants’ daughter, A.L., re-
 ceived the DTaP, Hib, and MMR vaccines at her fifteen-
 month well-child visit. Appx3. On September 29, 2016,
 A.L. was taken to the emergency room with a rash, bleed-
 ing gums, and black spots on her tongue. Id. A.L. was ad-
 mitted to the hospital where doctors discovered a low
 platelet count and presumed A.L. was suffering from im-
 mune thrombocytopenic purpura (“ITP”). 2 Appx1102. A.L.

     2   ITP is defined in the Vaccine Injury Table as the
 “presence of clinical manifestations, such as petechiae, sig-
 nificant bruising, or spontaneous bleeding, and by a serum
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 4                                             LEMING v. HHS

 received one dose of intravenous immunoglobulin (“IVIG”)
 as a treatment for the ITP. A.L. failed to respond to the
 initial IVIG treatment. She was transferred to Children’s
 Hospital in Omaha, where she received a second dose of
 IVIG. She again showed no improvement.
     After A.L. failed to respond to two doses of IVIG, the
 doctors conducted a bone marrow aspiration and biopsy to
 ensure that A.L. was not suffering from cancer or other
 blood cell disorders. Appx3. The aspiration and biopsy
 showed no evidence of cancer or blood cell disorders. Id.
 The doctors then gave A.L. intravenous steroids, which im-
 proved her platelet count. Id. On October 12, 2016, A.L.
 was discharged from the hospital. Id.
     Between October 12 and November 21, 2016, A.L. had
 multiple follow-up visits with the treating hematologist,
 who consistently noted improving platelet counts and less-
 ening symptoms. Appx43-44.
     On December 30, 2016, A.L.’s hematologist noted that
 A.L. was asymptomatic and had a normal platelet count.
 At this visit, it was also noted that A.L.’s ITP “had likely
 resolved at this time.” Appx2209. On April 13, 2017, the
 hematologist stated that A.L. was “completely free of bleed-
 ing symptomology.” Appx2238. At another visit on June
 29, 2017, while some bruising was reported on A.L.’s face
 and ear, and her blood smear indicated evidence of “giant
 platelets,” A.L. had a normal platelet count and the doctor
 wrote that A.L.’s mild B cell elevation was “likely due to
 the immature immune system at her age and new B cell
 differentiation following the ITP episode now resolved.”
 Appx2256.

 platelet count less than 50,000/mm3.”           42 C.F.R.
 § 100.3(c)(7).
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 LEMING v. HHS                                               5

                               C
      In February 2018, Victoria Leming and Kevin Leming
 (“the Lemings”) filed a petition for compensation as guard-
 ians of A.L. under the Vaccine Act, alleging that the vac-
 cines A.L. received at her fifteen-month well-child visit
 caused A.L. to suffer from ITP, immune dysfunction, and
 immune deficiency. The Secretary challenged the petition.
 The first special master issued a Ruling on the Facts, find-
 ing that the Lemings did not establish by a preponderance
 of the evidence that A.L. suffered the residual effects of the
 vaccine injury for more than six months. However, the spe-
 cial master found that the Lemings did establish that A.L.
 underwent an inpatient hospitalization and surgical inter-
 vention to meet the Vaccine Act’s severity requirement.
      On review, the Court of Federal Claims found that the
 special master’s decision on “surgical intervention” was
 contrary to law. See Leming v. Sec’y of Health & Hum.
 Servs., 154 Fed. Cl. 325, 334 (2021). The court below found
 that dictionary definitions and the legislative history of §
 300aa-11(c)(1)(D)(iii) “suggest that the intent of the ‘surgi-
 cal intervention’ language was to cover surgical procedures
 that are performed to directly treat or alter the course of a
 vaccine-related injury, as opposed to those whose purpose
 is to determine what treatment to employ.” Id. Finding
 that the bone marrow aspiration and biopsy performed on
 A.L. was purely diagnostic, the court below reversed the
 decision of the original special master and remanded for
 further proceedings.
     On remand, the case was reassigned to another special
 master who requested the Lemings offer more evidence to
 address the “residual effects” prong of the severity require-
 ment. The Lemings provided new arguments and a sup-
 plemental affidavit from Ms. Leming. The special master
 found that the Lemings still could not prove that A.L. suf-
 fered from the “residual effects” of the vaccine injury for
 more than six months in light of this Court’s decision in
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 6                                             LEMING v. HHS

 Wright v. Secretary of Health and Human Services, 22
 F.4th 999, 1001-02 (Fed. Cir. 2022), issued after the Court
 of Federal Claims’ reversal of the original special master
 decision on the Lemings’ petition. The Lemings filed a mo-
 tion for reconsideration, which was denied. The Lemings
 again appealed to the Court of Federal Claims, which af-
 firmed the decision of the second special master on residual
 effects.
     The Lemings timely appeal both the Court of Federal
 Claims’ decision on “surgical intervention,” Leming, 154
 Fed. Cl. at 325, and the second special master’s finding on
 “residual effects.” We have jurisdiction pursuant to 42
 U.S.C. § 300aa-12(f).
                         DISCUSSION
     The statutory construction of “surgical intervention” in
 § 300aa-11(c)(1)(D) is a question of law, subject to de novo
 review. See Wright, 22 F.4th at 1004.
                              A
     We are first tasked with defining “surgical interven-
 tion” as the phrase is used in the Vaccine Act. 42 U.S.C. §
 300aa-11(c)(1)(D)(iii). As explained below, we hold the
 term “surgical intervention,” read with the entirety of 42
 U.S.C. § 300aa-11(c)(1)(D)(iii), requires a surgical act or
 measure, either diagnostic or therapeutic, taken to prevent
 harm to a patient or to improve the health of a patient.
      Statutory construction “begins with the language of the
 statute.” Hughes Aircraft Co. v. Jacobson, 525 U.S. 432,
 438 (1999) (internal citations and quotations omitted). We
 consider not just a “single sentence or word of the statute,
 but rather the ‘provisions of the whole law,’ its object, and
 its policy.” Wright, 22 F.4th at 1004 (quoting Dole v. United
 Steelworkers of Am., 494 U.S. 26, 35 (1990)). If the statute
 provides a clear answer, the inquiry ends there. Hughes
 Aircraft Co., 525 U.S. at 438. “Beyond the statute’s text,
 [the traditional tools of statutory construction] include the
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 LEMING v. HHS                                                7

 statute’s structure, canons of statutory construction, and
 legislative history.” Timex V.I., Inc. v. United States, 157
 F.3d 879, 882 (Fed. Cir. 1998).
     Starting with the phrase “surgical intervention,” like
 the Court of Federal Claims, we recognize that the Vaccine
 Act does not define this phrase. As such, it is helpful to
 look at the phrase’s “ordinary meaning . . . at the time Con-
 gress enacted the statute.” Wisconsin Cent. Ltd. v. United
 States, 585 U.S. 274, 277 (2018) (quoting Perrin v. United
 States, 444 U.S. 37, 42 (1979)). Because neither we nor the
 parties were able to find a definition of the phrase “surgical
 intervention,” we look to the definitions of its individual
 components, “surgery” and “intervention,” for guidance.
      In 2000, one medical definition of “surgery” was “the
 branch of medicine that treats diseases, injuries, and de-
 formities by manual and operative methods.” Dorland’s Il-
 lustrated Medical Dictionary at 1736-37 (29th ed. 2000).
 This definition does not limit “surgery” to the purpose of
 the procedure, e.g., whether it is primarily therapeutic ver-
 sus diagnostic. The same dictionary defines “intervention”
 as: “1. the act or fact of interfering so as to modify. 2. spe-
 cifically, any measure whose purpose is to improve health
 or to alter the course of a disease.” Id. at 911. Relying on
 these Dorland’s dictionary definitions taken together, we
 understand “surgical intervention” to require an act or
 measure taken to prevent harming of a patient or to im-
 prove the health of a patient, and is of the surgical variety,
 for either diagnostic or therapeutic purposes.
     It is also helpful to look to neighboring terms and
 phrases. See United States v. Williams, 553 U.S. 285, 294
 (2008) (“[A] word is given more precise content by the
 neighboring words with which it is associated.”). Here,
 “surgical intervention” exists in the larger phrase “inpa-
 tient hospitalization and surgical intervention.” 42 U.S.C.
 § 300aa-11(c)(1)(D)(iii). “Inpatient hospitalization” works
 together with “surgical intervention” to provide a
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 8                                              LEMING v. HHS

 benchmark for the class of petitioners that Congress in-
 tended to meet the severity requirement of the Vaccine
 Act—that is, those individuals who “suffered such illness,
 disability, or condition from the vaccine,” that are severe
 enough to result in “inpatient hospitalization and surgical
 intervention.” Id. By requiring “inpatient hospitalization”
 in addition to surgical intervention, Congress limited the
 type of injury required to qualify for relief. Notably, Con-
 gress did not limit the type of injury required for relief by
 limiting the purpose of the surgical intervention received.
 Marx v. Gen. Revenue Corp., 568 U.S. 371, 381 (2013) (the
 courts should resort to the canon of expressio unius, the in-
 clusion of a term means exclusion of the other, when the
 context indicates that congress indeed considered “the un-
 named possibility and meant to say no to it.”).
     The legislative history accords with our understanding
 of the term “surgical intervention.” Although the legisla-
 tive record leading to the 2000 Amendment of the severity
 requirement is sparse, the Amendment’s sponsors referred
 to the need to expand compensation for those who suffered
 from intussusception, a negative effect of the rotavirus vac-
 cine that required surgery to remedy but did not typically
 produce residual effects lasting longer than six months.
 The 2000 Amendment’s language is not limited to cases of
 intussusception, or any other specific vaccine-related in-
 jury. One of the cosponsors, in supporting the 2000
 Amendment, stated “[t]he modified program makes com-
 pensation available if the injury requires a hospital stay or
 surgery.” 146 Cong. Rec. H8206 (daily ed. Sep. 27, 2000)
 (statement of Rep. Gilman).
     Additionally, the original language proposed in 1999
 included “(iii) suffered such illness, disability, injury or
 condition from which resulted in inpatient hospitalization
 and surgical intervention to correct such illness, disability,
 injury or condition.” 145 Cong. Rec. S15213 (daily ed. Nov.
 19, 1999) (emphasis added). The language in italics was
 omitted from the final version of the Amendment. This
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 LEMING v. HHS                                               9

 limited legislative history leads us to believe that Congress
 intended for the “surgical intervention” language to expand
 access to recovery for those injured by the vaccines, not
 limit it.
                               B
     Here, the court below distinguished between surgical
 procedures that are diagnostic and surgical procedures
 that are required to treat the vaccine injury, holding that
 purely diagnostic procedures do not qualify as “surgical in-
 terventions” under the Vaccine Act. See Leming, 154 Fed.
 Cl. at 333. We find no support for this distinction between
 diagnostic and therapeutic surgical procedures in the Vac-
 cine Act.
     The 2000 Amendment requires only that the petition-
 ers establish the vaccine recipient “suffered such illness,
 disability, injury, or condition from the vaccine which re-
 sulted in inpatient hospitalization and surgical interven-
 tion.” 42 U.S.C. § 300aa-11(c)(1)(D)(iii). In light of the
 conjunctive quality of the clause “inpatient hospitalization
 and surgical intervention,” we hold that any surgical pro-
 cedure—i.e., a surgical act or measure for diagnostic or
 therapeutic purposes taken to prevent harm of a patient or
 to improve the health of a patient—required to be con-
 ducted as a result of the vaccine injury qualifies, so long as
 the vaccine recipient is also hospitalized as an inpatient.
 Further, the hospitalization and the surgery must both be
 causally related to the recipient’s negative reaction to the
 vaccine.
     Here, under the proper interpretation of “surgical in-
 tervention,” there is no dispute that the bone marrow aspi-
 ration and biopsy performed on A.L. was a surgical
 intervention. It was a surgical act taken to improve the
 health of and prevent harm to A.L. The record demon-
 strates that A.L. was hospitalized for two weeks as a result
 of her negative reaction to the vaccine, and also had to un-
 dergo a bone marrow aspiration and biopsy because she did
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 10                                           LEMING v. HHS

 not react to the initial ITP treatment. Appx1102. These
 undisputed facts on their face satisfy 42 U.S.C. § 300aa-
 11(c)(1)(D)(iii).
                        CONCLUSION
     Accordingly, we reverse the Court of Federal Claims’
 determination that A.L. does not satisfy 42 U.S.C. § 300aa-
 11(c)(1)(D)(iii) and remand for further proceedings con-
 sistent with this opinion. 3
                REVERSED AND REMANDED
                           COSTS
  Costs awarded to petitioners.

      3   In finding that the Lemings have satisfied the se-
 verity requirement via the “surgical intervention” lan-
 guage, we find it unnecessary to address the “residual
 effects” argument.