Leming v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 18-0232V

Filed: July 12, 2019

VICTORIA LEMING and KEVIN

LEMING, Parents and Natural

Guardians of A.L., a Minor, Finding of Fact; Surgical Intervention;

Bone Marrow Aspiration; Special

Petitioners, Processing Unit (“SPU”)

v.

SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

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”).

1

The undersigned intends to post this ruling on the United States Court of Federal Claims' website. This

means the ruling will be available to anyone with access to the internet. In accordance with Vaccine

Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the

disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned

agrees that the identified material fits within this definition, the undersigned will redact such material from

public access. Because this unpublished ruling contains a reasoned explanation for the action in this

case, undersigned is required to post it on the United States Court of Federal Claims' website in

accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management

and Promotion of Electronic Government Services).

2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755.

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-

3 Platelet count the morning of September 30, 2016, was 1,000. Ex. 8 at 215.

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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

is notable, however, that “residual effects or complications’” and “symptomatic” are not

synonymous. Faup v. Sec’y of Health & Human Servs., 12-87V, 2015 WL 443802, *4

(Fed. Cl. Spec. Mstr., January 23, 2015) (one can suffer from a disease without

exhibiting any clinical signs thereof). The ongoing need for medication can constitute a

“residual effect” of an injury. Id.

Respondent argues that A.L. was symptom-free little more than two months after

vaccination and therefor did not suffer ITP-related sequela for six months. Resp. Mot.

at 3-4 (citing Ex. 9 at 45-51 (normalized platelet count); Ex. 10 at 9). Petitioners argue

that A.L. experienced the adverse effects of immune dysfunction, weight gain, and

bruising more than six months after vaccination. Pet’rs’ Mot. at 34-37. Although A.L.

may have been symptom-free within three months of her September 6, 2006

vaccinations, the undersigned reviews whether her medical records establish any

“residual effect or complication” lasting six months or more.

i. Weight Gain

Petitioners argue that A.L. experienced weight gain directly attributable to the

steroid treatment she received for ITP. Pet’rs’ Mot. at 35-36. Petitioners outline that

A.L. weighed 10.0 kilograms on the date of vaccination (September 6, 2016, 15 months

old), and gained weight incrementally, reaching 12.25 kilograms on April 17, 2017 (22

months old). Pet’rs’ Mot. 35-36 (internal citations omitted). Petitioners state this weight

gain is a residual effect of A.L.’s ITP treatment.

A.L.’s records note “increased appetite” and “face swelling” due to steroids on

November 1, 2016 (Ex. 9 at 11, 30), but it is not clear that her increasing weight was

related to the steroid therapy she completed on November 6, 2016 (Ex. 9 at 46).

Petitioners point to A.L.’s weight gain in the five months following the completion of her

ITP treatment. Pet’rs’ Mot. at 36. Yet, A.L.’s “increased appetite” had resolved by her

November 21, 2016 hematology appointment. Ex. 9 at 45.

A.L.’s records in the months following the completion of steroid treatment also

show incremental growth. On December 30, 2016, during an appointment with Dr.

Amanda Grimes at the Hematology Center of Texas Children’s Hospital, A.L. measured

32.48 inches tall and weighed 26 pounds, 10.8 ounces. Ex. 9 at 58. A.L. charted in the

88th percentile for weight, 59th percentile for height, and had a BMI of 17.78. Id. At a

follow-up appointment with Dr. Grimes on April 13, 2017, A.L. measured 33.39 inches

tall and weighed 26 pounds, 14.3 ounces. Ex. 9 at 88. A.L. charted in the 77th

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percentile for weight, 46th percentile for height, and had a BMI of 16.97. Id.4 On June

29, 2017, A.L. was seen by Dr. Lisa Forbes at Texas Children’s Hospital and measured

over 34 inches tall and weighed 28 pounds. Ex. 10 at 3. A.L. charted in the 63 rd

percentile for weight, 65th percentile for height, and had a BMI of 16.66. Id. at 3-4.

Overall, A.L.’s records do not indicate her treating physicians were concerned about her

weight or growth.

Petitioners provided an article on corticosteroid treatment of ITP as support for

their position that A.L.’s weight gain is a known adverse effect of steroid treatment. Ex.

19.5 While the article mentions weight gain as an adverse effect of steroid treatment, it

does not specify whether weight gain could continue after completed treatment. Nor

does it address the nuances of distinguishing “adverse effect” weight gain from normal

growth throughout the second year of life. Absent additional information, the

undersigned cannot determine whether A.L.’s increasing weight was an adverse effect

of her ITP treatment.

ii. Immune Dysfunction

Likewise, petitioners’ argument that A.L. experienced immune disfunction for

more than six months after vaccination is not persuasive. Petitioners argue A.L. was

diagnosed with T-Cell immunodeficiency during treatment of her ITP, and that her

immune system remained “abnormal” for more than six months after vaccination. In

particular, petitioners cite to a note by Dr. Lisa Forbes created on June 29, 2017, during

a follow up appointment:

Will recheck B cell subsets today. If trending toward normal the mild

elevation is likely due to the immature immune system at her age and new

B cell differentiation following the ITP episode now resolved . . . If the level

continues to increase there will be concern for immune dysfunction with

potential for recurrence of autoimmune disease . . . We discussed this plan

at length with mom and dad. They understood and will await the results and

next steps for follow up.

Ex. 10 at 9 (internal medical coding omitted); Pet’rs’ Mot. at 35 (incorrectly citing Ex. 16

at 46). This note discusses what steps are to be taken dependent on whether the

bloodwork ordered that day showed signs of immunodeficiency. Ex. 10 at 9. Yet, the

results were “good,” A.L.’s next follow up appointment was canceled, and no further

treatment was ordered. Ex. 10 at 8-9; Ex. 12 at 2. Thus, the undersigned finds that

4

At a chiropractic appointment on April 17, 2017, A.L. measured 31 inches tall, weighed 27 pounds, and

“overweight” was noted as a symptom. Ex. 16 at 46. This record appears inconsistent with A.L.’s other

contemporaneously recorded height measurements. A.L.’s other records do not identify her as

overweight at this time.

5

David Garcia, MD, Corticosteroids for ITP: A Comparison of Two Approaches, The Hematologist:

Diffusion, March 25, 2016 (http://www.hematology.org/TheHematologist/Diffusion/5373/aspx).

6

A.L. did not suffer immune dysfunction or dysregulation persisting for more than six

months after her September 6, 2016 vaccinations.

iii. Continued Bruising

Lastly, petitioners argue that A.L. suffered continued ITP-related bruising more

than six months after vaccination. Pet’rs’ Mot. at 37. Petitioners cite to A.L.’s

immunology records for support of their position. Id. (citing Ex. 10 at 1). During a June

29, 2017 visit to Dr. Forbes, the history notes that “mother feels that patient is still

bruising easier than other children” and bruising is noted on A.L.’s left cheek and left ear

pinna. Ex. 10 at 1, 4. Dr. Forbes ordered a B Cell Subset Panel which returned normal

results. Ex. 10 at 8-9. Dr. Forbes’ office later contacted A.L.’s mother to cancel her

September 2017 follow-up appointment after review of the ordered lab was normal. Ex.

12 at 2. A.L.’s treating immunologist did not attribute any June 29, 2017 bruising to

A.L.s’ previous ITP diagnosis. The undersigned declines to as well.

Thus, the undersigned finds that petitioners have not established by

preponderant evidence that A.L. suffered residual effects of her ITP for six months after

her vaccination.

b. Surgical Intervention

The parties dispute whether the bone marrow aspiration and biopsy that A.L.

underwent constitutes a “surgical intervention” as set forth in the Vaccine Act. 42

U.S.C. § 300aa-11(c)(1)(D)(iii). There is no definition of “surgical intervention” within the

Vaccine Act. See §300aa-33 (Definitions). Nor is there any Federal Circuit decision

interpreting that term. As described in prior decisions by special masters, the “surgical

intervention” language was added to the Vaccine Act to allow for recovery for

intussusception, which often requires surgery but does not typically persist for six

months. Spooner, 2014 WL 504728; Stavridis v. Sec’y of Health & Human Servs., No.

07-261V, 2009 WL 3837479 (Fed. Cl. Spec. Mstr. Oct. 29, 2009); Ivanchuk, 2015 WL

6157016.

In Spooner, the special master interpreted 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.” 2014 WL 504278, *10. In that case,

the special master based his definition of surgical intervention on entries from Dorland’s

Illustrated Medical Dictionary (29th Edition). Id. He noted that the Federal Circuit has

approved of the use of medical dictionaries to define statutory medical terms. Id. (citing

Abbot v. Sec’y of Health & Human Servs., 19 F.3d 39 (Fed. Cir. 1994)). Utilizing the

above definition, the special master determined that a lumbar puncture conducted under

general anesthesia was surgical in nature, but did not constitute an “intervention,”

because it was diagnostic and not necessary for treatment. Id. at 12. Conversely, the

special master determined that IVIG, though for treatment, was not surgical in nature.

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Id. The undersigned agrees with the definition of surgical intervention identified in

Spooner.6

Here, respondent, argues for a statutory interpretation that looks beyond medical

dictionary definitions of “surgical intervention” to the Congressional intent of the

language. Resp. Mot. at 5. While “surgical intervention” may be a term of art adopted

by Congress, respondent has not presented an argument that the term fails to be

defined “by reference to the art or science to which [it is] appropriate.’” Spooner, 2014

WL 504728, at *10 (citing Corning Glass Works v. Brennan, 417 U.S. 188, 201 (1974)

(quoting Greenleaf v. Goodrich, 101 U.S. 278, 284 (1880)). Without a reason to set

aside the common, medically specific, definition of “surgical intervention,” the

undersigned does not agree that the statutory language is sufficiently ambiguous to

allow consideration of Congressional intent. Hellebrand v. Sec'y of Health & Human

Servs., 999 F.2d 1565, 1569 (Fed. Cir. 1993) (citing Brookside Veneers, Ltd. v. United

States, 847 F.2d 786, 788 (Fed. Cir.), cert. denied, 488 U.S. 943 (citations omitted) (It is

a “general rule of statutory construction that where Congress has clearly stated its intent

in the language of a statute, a court should not inquire further.”)). Had respondent

justified consideration of the legislative history, the undersigned still finds the definition

of surgical intervention set forth in Spooner to be more persuasive, which also includes

an analysis of Congressional intent. Spooner, 2014 WL 504728, at *11.

In this case, the undersigned finds preponderant evidence that A.L. underwent a

surgical procedure. In order to perform the bone marrow aspiration and biopsy, A.L.

was placed under general anesthesia and the procedure was performed by a physician.

Ex. 4 at 22; Ex. 1 at 13; Ex. 2 at 204. A preoperative checklist was completed. Ex. 4 at

72-83. A.L.’s mother signed a consent for a surgical procedure.7 A.L. was monitored

by the Post Anesthesia Care Unit (“PACU”) following the procedure. Ex. 4 at 81.

The undersigned also finds that A.L.’s bone marrow aspiration and biopsy

constituted a surgical intervention. Although a bone marrow biopsy is, typically, not a

treatment that alters the course of a disease or condition, the facts of this case present

an atypical situation. Although A.L. presented with symptoms consistent with ITP, she

6 In the earlier Stavridis decision, the chief special master rejected essentially the same definition adopted

in Spooner, contending that it was overly broad. 2009 WL 3837479, *4. In that case, the chief special

master accepted the unrebutted opinion of respondent’s medical expert that steroid treatments and blood

transfusions should not be understood as surgical interventions. Id. at *6. That decision did

acknowledge, however, that there is a “large gray area between treatments that are definitely considered

‘surgical intervention’ and those that are not.” Id. at *6. In this case, the medical records offer sufficient

detail to address this issue without the need for further medical opinion.

7

Notably, the authorization form used in A.L’s case is titled “Authorization For And Consent To Surgery

Or Special Diagnostic Or Therapeutic Procedures.” Ex. 4 at 658. Dr. James Harper reviewed the

procedure with A.L.’s mother, answered her questions about post-operative pain, and obtained her

consent. Ex. 4 at 53. Consent for the bone marrow aspiration procedure is noted elsewhere in the record

including within in the pre-operative checklist. Ex. 4 at 74 (“Pre-op” checklist), 106. A.L.’s mother also

provided consent for intravenous anesthesia. Ex. 4 at 80.

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did not respond to initial therapies including IVIG. Ex. 4 at 16. A.L.’s treating

physician, Dr. James Harper, ordered and performed the bone marrow aspiration and

biopsy to rule out bone marrow disorders for which steroid treatment would be

contraindicated. Id. at 21, 41. The steroid treatment ordered following A.L.’s bone

marrow biopsy results eventually improved her ITP condition. Id. at 11-12; Ex. 9 at 45-

46. Because the medical record explicitly indicates that the bone marrow biopsy was

required in order to institute treatment rather than diagnose A.L.’s condition, the bone

marrow biopsy was a necessary and integral part of the overall treatment protocol that

ultimately cured A.L.’s ITP. Ivanchuk, 2015 WL 6157016, at *2 (bone marrow aspiration

can qualify as a “surgical intervention” under the Vaccine Act).

Thus, the undersigned finds that petitioners have provided preponderant

evidence that A.L.’s alleged vaccine injury resulted in inpatient hospitalization and

surgical intervention in accordance with the Vaccine Act. 42 U.S.C. § 300aa-

11(c)(1)(D)(iii). This finding is narrowly tailored to the facts and circumstances

presented by this case and is not a finding that bone marrow biopsy constitutes a

surgical intervention in all circumstances.

V. Conclusion

For all these reasons, I find that petitioners have established A.L.’s alleged

injury meets the severity requirement described in §300aa-11(c)(1)(D) of the

Vaccine Act.

s/ Nora Beth Dorsey

Nora Beth Dorsey

Chief Special Master

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