Leming v. Sec'y of Health & Human Servs.

• Decision Date: 12 July 2019
• Docket Number: No. 18-0232V,18-0232V
• 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

VICTORIA LEMING and KEVIN LEMING, Parents and Natural Guardians of A.L., a Minor, Petitioners,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.

No. 18-0232V

United States Court of Federal Claims

July 12, 2019

OFFICE OF SPECIAL MASTERS

Finding of Fact; Surgical Intervention; Bone Marrow Aspiration; Special Processing Unit ("SPU")

Robert Joel Krakow, Law Office of Robert J. Krakow, P.C. New York, NY, for petitioner.
Brittany Alexandra Anne Ditto, U.S. Department of Justice, Washington, DC, for respondent.

RULING ON FACTS¹

On February 14, 2018, Victoria and Kevin Leming ("petitioners") filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.,² (the "Vaccine Act" or "Program"), on behalf of their minor daughter, A.L. The petition alleges that a measles-mumps-rubella-varicella ("MMRV"), a diphtheria-tetanus-acellular pertussis ("DTaP"), and/or a Haemophilus influenzae type b ("Hib") vaccine that A.L. received on September 6, 2016, caused her to suffer from immune thrombocytopenic purpura ("ITP"), immune dysfunction, and immunodeficiency. Petition at 1. The case was assigned to the Special Processing Unit ("SPU").

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I. Procedural History

In support of the petition, petitioners filed medical records and declaration. ECF Nos. 5 & 6 (Exs. 1-10 (medical records), and 11 (Declaration of Victoria Leming)). An initial status conference was held on March 28, 2018. Following the conference, respondent was ordered to provide his position in the case indicating whether he was amenable to settlement. Order, ECF. No. 10. At respondent's request, petitioners filed additional medical records (ECF Nos. 19 & 24 (Exs. 12 &13)). Petitioners also filed additional declarations (ECF No. 25 (Ex. 14 (Declaration of Trisha Prewitt), ECF No. 15 (Second Declaration of Victoria Leming)).

Respondent filed his Rule 4(c) report on December 21, 2018, contesting petitioners' claim to vaccine injury compensation. Resp. Rep., ECF No. 34. In it, respondent states that petitioners have not established by preponderant evidence that A.L. either:

[Suffered] the residual effects or complications of a vaccine-related injury for more than six months after the administration of the vaccine . . . or alternatively, that [A.L.'s] injury resulted in inpatient hospitalization and surgical intervention.

Resp. Rep. at 5 (citing 42 U.S.C. § 300aa-11(c)(1)(D)(i), (iii)). In support of this position, respondent argues that A.L.'s inpatient bone marrow aspiration procedure, like the lumbar puncture procedure discussed in Spooner, does not constitute a "surgical intervention" under the Vaccine Act. Id. (citing Spooner v. Sec'y of Health & Human Servs., No. 13-159V, 2014 WL 504728, at *10-13 (Fed. Cl. Spec. Mstr., Jan. 16, 2014)).

Following the filing of respondent's report, a status conference was held on February 14, 2019 to discuss future proceedings. ECF No. 35. During the conference, petitioners' counsel posited that the facts of A.L.'s case more closely tracked those in Ivanchuk v. Sec'y of Health & Human Servs., No. 15-357V, 2015 WL 6157016, at *2 (Fed. Cl. Spec. Mstr., Sept. 18, 2015) (bone marrow aspiration can qualify as a "surgical intervention" under the Vaccine Act).

Acknowledging this dispute, the undersigned deemed it appropriate to proceed with a fact ruling to resolve whether petitioners' claim meets the statutory severity requirement. Order, ECF No. 35. A schedule for briefing was set. Id.

Prior to filing their motion for fact ruling, petitioners filed additional medical records. ECF No. 36 (Ex. 16), ECF No. 37 (Ex. 17). The parties filed concurrent motions for fact ruling on March 26, 2019. ECF Nos. 38 (Resp. Mot.) & 39 (Pet'rs' Mot.). Attached to their motion, petitioners provided three additional exhibits (Exs. 18-20). Responsive briefing was not scheduled. The matter is now ripe.

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II. Factual History

The undersigned has reviewed all the records in this case as well as respondent's Rule 4(c) report and the parties' motions for ruling. The undersigned finds that the recitation of facts in the Rule 4(c) report is accurate and is set forth below for the purpose of providing a history for this Ruling.

A.L. was born on May 26, 2015. Ex. 8 at 10. On the day of her birth, she was briefly transferred to the NICU for hypoglycemia that resolved the same day. Id. at 7-9. In her first 15 months, her medical history is significant only for ear infections that required bilateral tube placements. Ex. 5 at 6; Ex. 1 at 48. She had no complications following tube placement. Ex. 5 at 3.

On September 6, 2016, A.L. was seen for her 15 month well visit. Her exam was normal, and she received DTaP, Hib, and MMRV vaccinations. Ex. 1 at 37-39. On September 16, 2016, 10 days post-vaccination, A.L.'s mother called her pediatrician to report that A.L. developed a rash and fever three days prior. Ex. 13 at 3. The fever had resolved, but the rash, described as raised and blotchy, remained. Id. Her mother did not report bruises and stated that A.L. was sleeping, eating, and drinking well. Id. She was told that it was likely viral roseola and that no treatment was needed. Ex. 8 at 214.

On September 29, 2016, 23 days after vaccination, A.L presented to the emergency room with a rash, bleeding gums, and black spots on her tongue. Ex. 8 at 209. An exam showed scattered bruising, a generalized petechial rash, and a low platelet count.³ Id. at 212-218. A.L. was admitted, and after receiving one dose of IVIG, she showed increased bruising and was transferred to Children's Hospital in Omaha on September 30, 2016. Id. at 225, 283. Upon admission to Children's Hospital, A.L.'s mother stated that she had bruising and bleeding for one week prior. Ex. 4 at 7-11. A.L. was given a second dose of IVIG and again showed no improvement. Id. at 16. During a hematology consultation, A.L.'s mother reported that A.L. had a fever of 102.7 degrees and a rash in the week following the vaccine. Id. at 19-22. A bone marrow aspiration and biopsy ruled out cancer and other blood cell disorders. Id. at 80-81, 111, 117. A.L. was treated with IV steroids and her platelet counts improved. Id. at 4. She was discharged on October 12, 2016. Id. at 3-5.

In follow-up with her hematologist on December 30, 2016 (three months and 24 days post-vaccination), it was noted that A.L. was receiving no further therapy; was asymptomatic; and had a normal platelet count. Ex. 9 at 60-67. She showed no easy bruising or petechiae, and her energy, activity, and appetite levels had returned to baseline. Id. at 61-67. The hematologist noted that the ITP "has likely resolved at this time and is unlikely to recur." Id. A follow-up visit on April 13, 2017, confirmed that A.L. remained "completely free of bleeding symptomology." Id. at 95. Her energy, activity, and appetite levels returned to baseline. A.L. had no easy bruising, no fever, and no significant infectious symptomatology. Id. Her mother was advised that routine follow-

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up was unnecessary unless the bleeding symptomatology recurred. Id. at 100. In follow-up on June 29, 2017, A.L. had a normal platelet count and elevated B cell percentages. Ex. 10 at 9, 93. A pediatric immunologist attributed the mild elevation to A.L.'s "immature immune system," and she noted that "the ITP episode [has] now resolved." No further treatment was recommended. Ex. 10 at 9.

III. Legal Standard

A petitioner must prove, by a preponderance of the evidence, the factual circumstances surrounding her claim. 42 U.S.C. § 300aa-13(a)(1)(A). To resolve factual issues, the special master must weigh the evidence presented, which may include contemporaneous medical records and testimony. Burns v. Sec'y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special master must decide what weight to give evidence including oral testimony and contemporaneous medical records). Contemporaneous medical records are presumed to be accurate. Cucuras v. Sec'y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). To overcome the presumptive accuracy of medical records testimony, a petitioner may present testimony which is "consistent, clear, cogent, and compelling." Sanchez v. Sec'y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec'y of Health & Human Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)).

Despite the weight afforded medical records, special masters are not bound rigidly by those records in determining onset of a petitioner's symptoms. Vallenzuela v. Sec'y of Health & Human Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see also Eng v. Sec'y of Health & Human Servs., No. 90-1754V, 1994 WL 67704, at *3 (Fed. Cl. Spec. Mstr. Feb. 18, 1994) (Section 13(b)(2) "must be construed so as to give effect also to § 13(b)(1) which directs the special master or court to consider the medical records (reports, diagnosis, conclusions, medical judgment, test reports, etc.), but does not require the special master or court to be bound by them").

IV. Discussion

In order to state a claim under the Vaccine Act, a vacinee must have either:

(i) suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the administration of the vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered such illness, disability, injury or condition from the vaccine which resulted in inpatient hospitalization and surgical intervention.

§300aa-11(c)(1)(D).

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a. Six Month Sequela

"[A]n increased risk of a recurrence without an actual recurrence of a condition is not medically recognized as a 'residual effect' and is not a residual effect within the meaning of § 300aa-11(c)(1)(D)(i) of the Vaccine Act." Parsley v. Sec'y of Health & Human Servs., 08-781V, 2011 WL 2463539, *5 (Fed. Cl. Spec. Mstr., May 27, 2011). It...