Leming v. Sec'y of Health & Human Servs.
| Decision Date | 16 June 2021 |
| Docket Number | No. 18-232V,18-232V |
| Parties | VICTORIA LEMING and KEVIN LEMING, Parents and Natural Guardians of A.L., A Minor, Petitioners, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. |
| Court | U.S. Claims Court |
Robert J. Krakow, Law Office of Robert J. Krakow, P.C., New York, NY, for Petitioner.
Julia M. Collison, Trial Attorney, Torts Branch, Civil Division, U.S. Department of Justice, Washington, DC, with whom were Alexis B. Babcock, Assistant Director, Heather L. Pearlman, Acting Deputy Director, C. Salvatore D'Alessio, Acting Director, and Brian M. Boynton, Acting Assistant Attorney General, for Respondent.
This case, which arises under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 ("Vaccine Act" or "the Act"), is before the Court on a motion for review filed by the Secretary of Health and Human Services ("the Secretary"). The Secretary challenges Special Master Nora B. Dorsey's ruling that a bone aspiration performed along with a biopsy to determine the proper treatment for petitioner A.L.'s vaccine-related injury was a "surgical intervention" for purposes of 42 U.S.C. § 300aa-11(c)(1)(D)(iii). The government contends that the Special Master's interpretation of the statutory language was legally erroneous and that additionally—because A.L.'s injury did not last more than six months, id. § 300aa-11(c)(1)(D)(i), nor result in her death, id. § 300aa-11(c)(1)(D)(ii)—her injury was not severe enough to satisfy the Act's minimum eligibility threshold.
For the reasons set forth below, the Court concludes that the Special Master's decision was contrary to law. While the bone aspiration was a surgical procedure, it was not a surgical "intervention." Id. § 300aa-11(c)(1)(D)(iii). The Secretary's motion for review, ECF No. 75, is therefore GRANTED.
On September 6, 2016, during a scheduled well-child visit, fifteen-month-old A.L. received the measles-mumps-rubella-varicella (MMRV) vaccine, the diphtheria-tetanus-acellular pertussis (DTaP) vaccine, and the Haemophilus influenzae type b (Hib) vaccine. Pet'r's Ex. 1 at 37-39, ECF No. 5-1. Within the next week, A.L. developed a rash and fever. Pet'r's Ex. 13 at 3, ECF No. 24-1. A.L.'s mother reported the rash to the pediatrician on September 16, 2016. Id. By this point, A.L. no longer had a fever, and she was sleeping and eating normally. Id. The pediatrician told A.L.'s mother that the rash was likely roseola and that no treatment was needed. Pet'r's Ex. 8 at 214, ECF No. 5-8.
A few days later, however, on September 29, 2016, A.L. presented to the emergency room with a petechial1 rash on her body and tongue, and bleeding gums. Id. at 215. A blood test revealed a low platelet count. Id.
A.L. was admitted to the hospital and administered one dose of intravenous ("IV") immunoglobulin. Id.2 After A.L. received the treatment, she exhibited increased bruising and the next day, on September 30, 2016, was transferred to Children's Hospital in Omaha. Id. She received a second dose of IV immunoglobulin at Children's Hospital and again showed no improvement. Pet'r's Ex. 4 at 16, ECF No. 5-4.
On October 1, A.L.'s consulting physician, Dr. Stefanie Lowas, recorded that immune thrombocytopenia purpura ("ITP") was the "most likely" explanation for A.L.'s symptoms, but that other diagnoses, albeit "very unlikely" ones, "could include congenital platelet disorders, acquired bone marrow failure, and leukemia." Id. at 21.3 Dr. Lowas commented that, while "IV[immunoglobulin] serves as a very good diagnostic and therapeutic measure for ITP, it may be ineffective in about 25% of patients with ITP." Id. For these patients, she explained, "[t]here are numerous other treatment options," but an ITP "diagnosis should be confirmed before any of these are given." Id. Dr. Lowas recommended that, if A.L.'s platelet count did not increase within the next two or three days, A.L. receive a "bone marrow aspirate/biopsy to rule out bone marrow disorders" and that "[a]fter that, other ITP therapies may be considered." Id.
In fact, A.L.'s platelet count did not improve over the next several days. As a result, and consistent with Dr. Lowas' recommendation, her treating physician, Dr. James Harper, agreed that A.L. "should have a bone marrow aspirate and biopsy to [rule out other diagnoses] before starting steroids." Id. at 53.
On October 4, 2016, Dr. Harper completed a preoperative checklist, id. at 74, and placed A.L. under general anesthesia, id. at 80. He conducted a bone marrow needle aspiration and biopsy. Id. at 79-81.4 The procedure yielded no evidence of cancer or other blood cell disorders. Id. at 117. Dr. Harper therefore concluded that there was no contraindication to A.L. starting IV steroid treatment for her ITP. Id. at 52.
A.L. thereafter received steroid treatment which was effective and resulted in an improvement in her platelet count. Id. at 4. As a consequence, A.L. was discharged from the hospital on October 12, 2016. Id. at 3-5. A follow-up examination was conducted on December 30, 2016, almost four months after A.L. received the vaccinations. Pet'r's Ex. 9 at 60-67, ECF No. 5-9. A.L.'s hematologist reported that her platelet counts were normal, and that she suffered from no other remaining symptoms. Id. at 60-61. In addition, a pediatric immunologist determined that A.L.'s ITP episode had resolved and that there was no need for further treatment. Pet'r's Ex. 10 at 9, ECF No. 5-10.
On February 14, 2018, A.L.'s parents, Victoria and Kevin Leming, filed a petition for compensation pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-1 to -34. In their petition, the Lemings alleged that the vaccines that A.L. received on September 6, 2016 caused her to experience immune thrombocytopenic purpura, immune dysfunction, and immunodeficiency. Pet. for Comp. Under the Vaccine Act at 1, ECF No. 1.
The case was assigned to then-Chief Special Master Nora Beth Dorsey on February 15, 2018. ECF No. 4. On December 21, 2018, the Secretary filed a Vaccine Rule 4(c) report. ECF No. 34. In it, he asserted petitioners were not eligible for compensation because they could not show that A.L. either suffered the residual effects or complications of a vaccine-related injury for more than six months after vaccination or that her injury resulted in inpatient hospitalization and surgical intervention, as required to satisfy the Act's so-called "severity" requirement. See Ruling on Facts ("Ruling") at 2, ECF No. 41 (). On March 26, 2019, both parties filed motions for a ruling on the facts. ECF Nos. 38 & 39.
Special Master Dorsey issued her Ruling on Facts on July 12, 2019. She determined that A.L. was entitled to compensation under the Vaccine Act. Ruling at 9. As pertinent to the present motion for review, Special Master Dorsey acknowledged that A.L. had not suffered ITP-related sequelae for six months as required to be eligible for compensation pursuant to clause (i) of 42 U.S.C. § 300aa-11(c)(1)(D). Ruling at 5-7. However, she found her eligible for compensation under clause (iii), concluding that the bone aspiration and biopsy performed on A.L. while she was hospitalized constituted a "surgical intervention." Ruling at 8-9 (citing 42 U.S.C. § 300aa-11(c)(1)(D)(iii)).
In her decision, Special Master Dorsey purported to endorse the interpretation of clause (iii) set forth in Spooner v. Secretary of Health and Human Services, No. 13-159V, 2014 WL 504728 (Fed. Cl. Jan. 16, 2014) (Moran, Special Master). See Ruling at 7. In that case, Special Master Moran, relying primarily upon Dorland's Illustrated Medical Dictionary, defined a surgical intervention as "the treatment of a disease, injury, and deformity with instruments or by the hands of a surgeon to improve health or alter the course of a disease." Spooner, 2014 WL 504728, at *10 (citing Dorland's Illustrated Medical Dictionary 911, 1736-37, 1265 (29th ed. 2000) (defining "intervention," "surgery," and "operation")); Ruling at 7. Applying this definition, Special Master Moran concluded that a lumbar puncture conducted under general anesthesia was a "surgical procedure," but that it was not a "surgical intervention," because the lumbar puncture is a diagnostic procedure and not one whose purpose is to treat an injury. Spooner, 2014 WL 504728, at *12.
Special Master Dorsey opined that A.L.'s bone aspiration and biopsy was both "surgical" and an "intervention." Ruling at 9. The procedure was a surgical one, she held, because: (1) A.L. was placed under general anesthesia; (2) "[a] preoperative checklist was completed"; (3) "A.L.'s mother signed a consent for a surgical procedure"; and (4) "A.L. was monitored by the [post-surgical anesthesia care unit] following the procedure." Id. at 8.
Special Master Dorsey further determined that the surgical procedure was an "intervention." Id. at 8-9. She acknowledged that "a bone marrow biopsy is, typically, not a treatment that alters the course of a disease or condition." Id. at 8. Rather, it is generally used for diagnostic purposes. However, Special Master Dorsey explained, "the facts of this case present an atypical situation" because "the bone marrow biopsy was required in order to institute treatment" and not to "diagnose A.L.'s condition." Id. at 8-9. In her view, the bone marrow biopsy was a surgical intervention because it was "a necessary and integral part of the overall treatment protocol that ultimately cured A.L.'s ITP." Id. at 9. Further, according to SpecialMaster Dorsey, her ruling was "narrowly tailored to the facts and circumstances presented by this case and is not a finding that [a] bone marrow biopsy constitutes a surgical intervention in all circumstances." Id.
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