Berenji v. Secretary of Health and Human Services

In the United States Court of Federal Claims

No. 14-699V

(E-Filed: January 24, 2020)1

)

JAMILEH BERENJI and BAHMAN )

YOUSEFI, on behalf of S.Y., ) Vaccinations (Influeza,

) Measles-Mumps-Rubella

Petitioners, ) (MMR), Varicella,

v. ) Pneumococcal Conjugate

) (Prevnar)); National Childhood

SECRETARY OF HEALTH ) Vaccine Injury Act of 1986, 42

AND HUMAN SERVICES, ) U.S.C. §§ 300aa-1 to -34

) (2012); Deferential Review of

Respondent. ) Special Master’s Fact Finding

) and Weighing of Evidence.

Mark T. Sadaka, Englewood, NJ, for petitioner.

Kyle E. Pozza, Trial Attorney, with whom were Joseph H. Hunt, Assistant Attorney

General, C. Salvatore D’Alessio, Acting Director, Catharine E. Reeves, Deputy Director,

Torts Branch, Civil Division, United States Department of Justice, Washington, DC, for

respondent.

OPINION

CAMPBELL-SMITH, Judge.

On August 30, 2019, the special master denied compensation to petitioners under

the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2012)

(the Vaccine Act). See ECF No. 111. 2 On September 27, 2019, petitioners filed a

1

Pursuant to Rule 18(b) of the Vaccine Rules of the United States Court of Federal Claims

(Appendix B to the Rules of the United States Court of Federal Claims), this opinion was

initially filed under seal on January 6, 2020. Pursuant to ¶ 4 of the ordering language, the parties

were to propose redactions of the information contained therein on or before January 21, 2020.

No proposed redactions were submitted to the court.

2

The court notes that proceedings before the special master in this case were unusually

complex. For clarity, the court emphasizes that its review in this opinion is limited to the special

master’s August 30, 2019 decision denying compensation to petitioners, ECF No. 111.

motion for review of the special master’s August 30, 2019 decision and a memorandum

in support of their motion for review. 3 See ECF No. 114, ECF No. 115. Respondent

filed its response brief on October 23, 2019. See ECF No. 119. Petitioners’ motion is

fully briefed and ripe for decision. As explained below, the special master’s entitlement

decision survives this court’s review. Accordingly, the court must DENY petitioners’

motion for review.

I. Background

On August 4, 2014, petitioners filed this case seeking compensation for an injury

allegedly suffered by their minor child as the result of receiving influenza (flu), measles-

mumps-rubella (MMR), varicella, and pneumococcal conjugate (Prevnar) vaccinations,

on October 17, 2011. See ECF No. 1. In reaching his decision, the special master

reviewed the child’s medical history in great detail, including the following facts relevant

to the court’s analysis of petitioners’ motion for review. 4

Petitioners’ son was born in October 2010. See ECF No. 111 at 6. He developed

normally and was generally healthy prior to his well-child examination on October 17,

2011. See id. at 7. At that appointment, the child received “his first MMR vaccination

and first influenza vaccination . . . as well as his first varicella vaccination and his fourth

pneumococcal vaccination.” Id. The child’s mother reported to the pediatrician that she

had a history of anemia. Accordingly, the doctor recommended that the child undergo a

hemogram (complete blood count). See id. The child’s blood was drawn the same

afternoon, and results showed that his platelet count was “significantly low,” his

hemoglobin count and hematocrit levels were “low,” and that his white blood cell count

was “normal.” Id. Repeated testing showed a decrease in all levels, most dramatically in

the platelet count. See id.

In light of these test results, the pediatrician referred the child to a specialist at the

Lucile Packard Children’s Hospital at Stanford University. See id. at 7-8. Following

additional testing, on October 19, 2011, the specialist diagnosed the child with Evans

syndrome, “‘an autoimmune process that results in hemolytic anemia and

3

Although petitioners’ memorandum is properly titled on the document, petitioners’

counsel selected the motion event when filing petitioners’ memorandum in the court’s case

management/electronic case filing (CM/ECF) system. For proper case management purposes

and docket clarity, the court must rule separately on petitioners’ memorandum and motion for

review in the final ordering language of this opinion.

4

For clarity of the narrative, the court cites to the special master’s decision and omits

direct citations to the record therein. The court also notes that the special master’s decision

includes a more detailed description of the child’s medical history than is necessary for the

analysis in this opinion.

2

thrombocytopenia.’” Id. at 8. On October 23, 2011, the child was “presented for

emergency attention following a one-day history of vomiting and diarrhea, as well as a

fever which had risen to approximately 104 degrees Fahrenheit.” Id. The child received

antibiotics, but two days later, he still had a fever of 102 degrees Fahrenheit. See id. On

October 25, 2011, the child’s pediatrician administered a second dose of antibiotics, and

discussed the cause of the child’s condition with petitioners. The doctor noted:

“Parents understandably very devastated by his recent diagnosis and mom

still very concerned that his recent 12-month vaccines, most notably, the

MMR, was the etiology of his current condition. Discussed that while the

stress of the vaccines may have triggered the disease to surface, it certainly

was not the cause of his Evan[s] syndrome.”

Id. (special master’s decision quoting doctor’s note).

On October 28, 2011, the child’s hematologist-oncologist noted that his fever had

resolved, but also recorded that the child had developed a rash. See id. at 9. The doctor

believed the rash was “‘probably post-viral,’” and advised the child’s mother that if the

child had developed measles after receiving the MMR vaccination “‘this rare occurrence,

concurrent with an apparently autoimmune pancytopenia, may raise a question of

previously undiagnosed immune deficiency.’” Id. Following additional testing, the

doctor recommended that the child be admitted to the hospital for observation. See id. On

his way to the hospital, the child experienced a seizure. See id. While at the hospital, the

child underwent still more testing which showed further decreases in his platelets,

hemoglobin, and hematocrit levels, but a slight increase in his white blood cell count,

though it remained lower than normal. See id. On October 29, 2011, the child received

additional antibiotics and intravenous immunoglobulin (IVIg). See id.

The child’s pediatric infectious disease specialist recorded, on October 29, 2011,

that the child’s “‘vaccinations could not have caused his anemia and thrombocytopenia,

which were documented less than one hour afterwards.’” Id. She also noted that “‘it is

possible that [the child’s] fever and rash (and less likely, afebrile seizure) were caused by

MMR, and that these are unrelated to the cause of his underlying bone marrow

suppression/autoimmune hemolytic anemia.’” Id.

On October 31, 2011, the child was evaluated by an immunologist who noted that

“‘[i]t is possible that he had two distinct processes happening simultaneously.’ First,

Evans syndrome probably represented a ‘true autoimmune process.’ Second, the MMRV

vaccine may have caused a self-limited febrile seizure episode.” Id. (citations omitted).

The child was discharged from the hospital, with a steroid prescription, on November 2,

2011. See id.

3

On November 4, 2011, the child was seen by a pediatrician as a follow-up to his

hospitalization. She found that the child was “doing well without further rash, fever, or

seizure activity.” Id. at 10. She further noted:

“[A]fter extensive workup by Infectious Disease and Immunology, the

general thought is that [the child] developed some rare but known

complication from his measles, mumps, and rubella vaccine which included

fever, a rash and seizure . . . . It is therefore likely that [the child] had two

different processes that occurred at the same time. We also believe that [the

child’s] Evans syndrome did not stem from this measles, mumps, and rubella,

as his thrombocytopenia was noted just one hour after his vaccine.”

Id. (special master’s decision quoting doctor’s note). And on November 10, 2011, the

hematologist-oncologist noted that the child’s “‘apparent vaccine-related illness has since

resolved.’” Id.

In December 2011, the child’s doctors “tried to taper him off steroids,” but he was

admitted to the hospital again on December 27, 2011, after tests showed low hemoglobin

and platelets. See id. “On December 31, 2011 [the child] started a five-day course of

IVIg which was associated with improved blood counts,” and “[h]e was discharged with

steroids on January 5, 2012.” Id.

“Due to continued thrombocytopenia on oral steroids, [the child] received four

infusions of Rituximab (an immunosuppressant) between February 13 and March 15,

2012. However, due to a lack of sustained response, on April 17, 2012, he was started on

cyclosporine (another immunosuppressant).” Id. In what doctors concluded was likely

an adverse reaction to the cyclosporine, the child experienced “an episode of non-

responsiveness and shaking lasting approximately 15 minutes,” on June 1, 2012. The

child experienced another seizure later the same month, and “[c]yclosporine was

discontinued and he was started on Keppra (an anti-seizure medication).” Id.

On July 17, 2012, the child “was started on CellCept (another

immunosuppressant).” Id. He was admitted to the hospital again from September 8-11,

2012, due to rectal bleeding. See id. While hospitalized “he received a platelet

transfusion and IVIg.” Id.

Test results on February 12, 2013, indicated that his “T and B cell subsets . . . were

normal,” meaning that “he had recovered from the Rituximab therapy in February-March

2012.” Id. at 11. Also on February 12, 2013, CellCept was discontinued. Id.

“Afterwards, [the child] was increasingly fatigued and less interested in playing and

ambulating. A non-productive cough present since November 2012 seemed to worsen in

frequency and productivity.” Id.

4

On February 22, 2013, the child underwent a bone marrow biopsy, and was

admitted to the hospital and began using supplemental oxygen due to his difficulty

breathing. See id. Because the results of the initial biopsy were “suspicious for

malignancy,” a repeat biopsy was performed on March 1, 2013, and showed:

While platelets are markedly decreased with circulating giant forms, the bone

marrow aspirates and biopsy sections show an abundant megakaryocytic

hyperplasia, including small immature forms. The finding of hyperplastic

megakaryocytes suggests the etiology of the thrombocytopenia is not poor

platelet production, but rather peripheral destruction and/or sequestration.

Both red cell and megakaryocyte/platelet findings are consistent with

immune-mediated destruction of red cells and platelets and have been

described in Evans syndrome.

Id.

The child was transferred to pediatric intensive care on March 7, 2013, “after he

developed seizure-like activities with tonic-clonic movements and ineffective breathing.

He was stabilized with non-invasive respiratory support.” Id. After experiencing another

seizure on March 9, 2013, he was started on Keppra, and the seizure activity subsided for

the remainder of his hospitalization. On March 28, 2013, a lung biopsy confirmed that

the child had pulmonary veno-occlusive disease (PVOD) “which related back to and

explained the respiratory problems which had begun in mid-February 2013.” Id. He was

“discharged with supplemental oxygen on April 8, 2013.” Id.

In August 2013, the child was admitted to the hospital “due to a pulmonary

infection that exacerbated his PVOD.” Id. The child was hospitalized again on

September 26, 2013, “for worsening jaundice, difficulty breathing, and high levels of

bilirubin and transaminases (liver enzymes).” Id. at 12. The child tested positive for

rhinovirus and parainfluenza, and a “liver cell biopsy showed syncytial giant cell

hepatitis, suggestive of autoimmune hepatitis.” Id. He was discharged on December 26,

2013. See id. 5

On August 4, 2014, petitioners filed their claim alleging that their son suffered

injuries as a result of receiving the flu, MMR, varicella, and Prevnar vaccinations. See

ECF No. 1. The special master agreed with the parties from the outset that “expert

reports would be necessary to understand the complex issues concerning [the child’s]

medical condition and the timing in this case.” ECF No. 111 at 2. Petitioners filed three

reports from Dr. M. Eric Gershwin, M.D., in support of vaccine causation. See id. at 2-3.

5

After the child was diagnosed with hepatitis, he continued to struggle with

hospitalizations and serious medical complications. No further recitation of the child’s condition

is necessary for purposes of this court’s analysis, however, because petitioners’ motion for

review addresses a narrow aspect of the special master’s decision.

5

Respondent filed two reports from Dr. Mehrdad Matloubian, M.D., and one report from

Dr. Joan Cox Gill, M.D., in which they disagreed with Dr. Gershwin on the causation

issue. See id. The special master held an entitlement hearing on August 14, 2017, at

which he heard testimony from petitioner Jamileh Berenji, Dr. Gershwin, Dr. Matloubian,

and Dr. Gill. See id. at 3.

After a lengthy consideration of the facts and argument, the special master’s

August 30, 2019 decision concluded as follows:

[T]here can be little question that [the child’s] condition became markedly

worse after receiving the vaccines on October 17, 2011. His treating doctors

generally thought that the process including fever, seizure and full body rash

were likely attributable to the vaccine. However, that short-term injury, if

attributed to the vaccines, did not last for more than six months. It is

significantly more difficult to find a logical and temporal association

between [the child’s] vaccinations and his long-term course which is at least

somewhat similar to other patients with Evans syndrome. The available

literature on this very rare disease suggests that Evans syndrome is chronic

and refractory to treatment. [The child’s] development of anitnuclear

antibodies, antiphospholipid antibodies, hepatitis, and PVOD seems

particularly rare. However, those conditions are unlikely to be caused by B

cells stimulated by the vaccines, which were eliminated and replaced in the

intervening time period. Thus, there is not a logical sequence of cause and

effect or an acceptable temporal association between the vaccinations and

[the child’s] long-term course.

Id. at 24-25 (footnote omitted). For these reasons, the special master ruled to dismiss

petitioners’ complaint. Id. On September 27, 2019, petitioners filed their motion for

review.

II. Legal Standards

This court has jurisdiction to review the decision of a special master in a Vaccine

Act case. 42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court of Federal

Claims reviews the decision of the special master to determine if it is ‘arbitrary,

capricious, an abuse of discretion, or otherwise not in accordance with law[.]’” de Bazan

v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1350 (Fed. Cir. 2008) (quoting 42

U.S.C. § 300aa-12(e)(2)(B) and citing Althen v. Sec’y Health & Human Servs., 418 F.3d

1274, 1277 (Fed. Cir. 2005)) (alteration in original).

This court uses three distinct standards of review in Vaccine Act cases, depending

upon which aspect of a special master’s judgment is under scrutiny.

6

These standards vary in application as well as degree of deference. Each

standard applies to a different aspect of the judgment. Fact findings are

reviewed . . . under the arbitrary and capricious standard; legal questions

under the “not in accordance with law” standard; and discretionary rulings

under the abuse of discretion standard.

Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir.

1992).

The third standard of review, abuse of discretion, is applicable when the special

master excludes evidence or otherwise limits the record upon which he or she relies. See

id. at 870. As this court has stated, the third standard applies to the special master’s

evidentiary rulings. Stillwell v. Sec’y of Health & Human Servs., 118 Fed. Cl. 47, 55

(2014) (citation omitted), aff’d, 607 F. App’x 997 (Fed. Cir. 2015). Determinations

subject to review for abuse of discretion must be sustained unless “manifestly erroneous.”

Piscopo v. Sec’y of Health & Human Servs., 66 Fed. Cl. 49, 53 (2005) (citations

omitted); see also Milmark Servs., Inc. v. United States, 731 F.2d 855, 860 (Fed. Cir.

1984) (holding that decisions within the trial court’s discretion are to be sustained unless

“manifestly erroneous”) (citation omitted).

A petitioner may obtain compensation if he or she “sustained, or had significantly

aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury

Table but which was caused by” certain vaccines, including the HPV vaccine. 42 U.S.C.

§ 300aa-11(c)(1)(C)(ii). A case for significant aggravation of an off-Table claim requires

proof, by a preponderance of the evidence, of:

(1) the person’s condition prior to administration of the vaccine, (2) the

person’s current condition (or the condition following the vaccination if that

is also pertinent), (3) whether the person’s current condition constitutes a

“significant aggravation” of the person’s condition prior to vaccination, (4)

a medical theory causally connecting such a significantly worsened condition

to the vaccination, (5) a logical sequence of cause and effect showing that

the vaccination was the reason for the significant aggravation, and (6) a

showing of a proximate temporal relationship between the vaccination and

the significant aggravation.

Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144 (2009); see also W.C. v.

Sec’y of Health & Human Servs., 704 F.3d 1352, 1360 (Fed. Cir. 2013) (referring to the

Loving test as “the correct law”).

7

III. Analysis

In their motion for review, petitioners challenge a narrow aspect of the special

master’s decision. Petitioners argue that the special master improperly “stops short of

finding that lung (veno-occlusive disease) and liver (autoimmune hepatitis) injuries that

[the child] suffered could have been caused by the vaccines largely based on one

undisclosed unsupported opinion made by respondent’s expert Dr. Matloubian on the

activity of [the] medication Rituximab in this specific case.” ECF No. 114 at 5.

Petitioners divide this objection into two parts. First, they claim that “[r]eliance on an

undisclosed net opinion impermissibly heightened petitioner’s burden in proving

causation.” 6 Id. at 6. And second, petitioners contend that “[a]ccepting unsupported

testimony at [the] hearing on key scientific issues was arbitrary, capricious, and an abuse

of the Special Master’s discretion.” Id. at 7. The court will address each argument in

turn.

A. The Special Master Applied the Correct Standard in Evaluating Petitioner’s

Causation Evidence

Petitioners argue that their “burden in prov[ing] causation was impermissibly

heightened by requiring a higher scientific standard beyond what is required under Althen

and its progeny.” Id. at 6. Specifically, they claim that “[p]etitioner’s burden was

heightened by crediting Dr. Matloubian’s net opinion that 99% of [the child’s] B cells

were destroyed by treatment with Rituximab.” Id. at 6-7 (citing ECF No. 111 at 24).

Petitioners’ argument on this point consists of the following:

First, Dr. Matloubian’s opinion regarding Rituximab was never disclosed and

should be stricken from the record. Second, he provided zero supporting

evidence for his testimony about the action of Rituximab in this specific case

making his opinion a net opinion and unreliable. . . . Not only does Dr.

Matloubian fail to provide any support generally about the activity of

Rituximab on B cells in a pediatric patient, he also fails to point to any

support for his opinion in the medical record again making it an inadmissible

net opinion. In fact, the current FDA approved prescription drug label for

Rituximab provides the following:

8.4 Pediatric Use

6

Petitioners repeatedly use the term “net opinion” to refer to Dr. Matloubian’s opinion at

issue, but they fail to define it. See, e.g., ECF No. 114 at 6-7. To the court’s knowledge, “net

opinion” is not a term of art, nor is it a term in common usage such that familiarity with the term

may be presumed. For this reason, the court does not include any specific discussion of what

petitioners mean to argue on this point.

8

The safety and effectiveness of RITUXAN in pediatric patients have not been

established.

Source: https://www.gene.com/download/pdf/rituxan_prescribing.pdf

Given the fact that it was not clear how instrumental Dr. Matloubian’s

undisclosed opinion was to the Special Master’s decision in this case until he

issued his decision, petitioner should be given the opportunity to address the

undisclosed opinion.

Id. at 7 (citations and footnotes omitted).

This argument does not articulate how the special master’s treatment of Dr.

Matloubian’s opinion affected petitioner’s burden of proof. It does suggest, however,

that: (1) respondent failed to meet a disclosure obligation; (2) the special master

improperly failed to require documentation in support of Dr. Matloubian’s oral

testimony; and (3) that the special master was required to notify the parties of the

evidence he found persuasive prior to issuing his decision. None of these requirements

are reflected in the rules or practices of the vaccine program.

The special master repeatedly affirmed the correct burden of proof, stating that

petitioners were required to prove their case by a preponderance of the evidence. See,

e.g., ECF No. 111 at 4, 15, 18 (citing Loving, 86 Fed. Cl. at 144). Indeed, the special

master was expressly cognizant of avoiding the very issue nominally raised by

petitioners. He wrote that “special masters must take care not to increase the burden

placed on petitioners in offering a scientific theory linking vaccine to injury.” Id. at 15

(citing Contreras v. Sec’y of Health & Human Servs., 121 Fed. Cl. 230, 245 (2015),

vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017)). He also noted, however, that

“this does not negate or reduce a petitioner’s ultimate burden to establish his overall

entitlement to damages by preponderant evidence.” Id. (citing W.C., 704 F.3d at 1356).

In addition, the special master diligently reviewed the evidence and arguments

presented by the parties, and emphasized that he had considered the entire record in

reaching his ultimate decision. See ECF No. 111 at 15-24 (discussing the various expert

theories at length); id. at 2 n.3 (“Pursuant to Section 13(a)(1), in order to reach my

decision, I have considered the entire record, including all of the medical records, expert

testimony, and literature submitted by the parties.”). And in reaching that decision, the

special master was “entitled—indeed, expected—to make determinations as to the

reliability of the evidence presented to [him] and . . . as to the credibility of the persons

presenting that evidence,” including experts. Moberly v. Sec’y of Health & Human

Servs., 592 F.3d 1315, 1326 (Fed. Cir. 2010)). As the special master stated, “[w]here

both sides offer expert testimony, a special master’s decision may be ‘based on the

credibility of the experts and the relative persuasiveness of their competing theories.’”

9

See ECF No. 111 at 6 (quoting Broekelschen v. Sec’y of Health & Human Servs., 618

F.3d 1339, 1347 (Fed. Cir. 2010)). See also Vaccine Rule 8(b)(1), Rules of the United

States Court of Federal Claims, Appendix B (“ In receiving evidence, the special master

will not be bound by common law or statutory rules of evidence but must consider all

relevant and reliable evidence governed by principles of fundamental fairness to both

parties.”).

The court concludes that the special master’s consideration of Dr. Matloubian’s

testimony was not only proper, but because he found the testimony relevant and reliable,

such consideration was required.

B. The Special Master’s Consideration of Dr. Matloubian’s Testimony Was

Not Arbitrary, Capricious, or an Abuse of Discretion

Petitioner’s second argument is one sentence long: “As articulated above, the

Special Master’s decision to rely on Dr. Matloubian’s undisclosed unsupported decision

on the issue of logical sequence of cause and effect was arbitrary and capricious.” ECF

No. 114 at 8. The court disagrees. For the reasons explained above, the special master’s

decision was well-founded and appropriately rendered.

IV. Conclusion

In the conclusion of his decision, the special master stated: “I wish to extend my

sympathy to [the child] and his family in the light of the enormous suffering they have

experienced in association with his Evans syndrome.” ECF No. 111 at 25. The court

likewise acknowledges the child’s and the family’s suffering and echoes the special

master’s sympathy. For the above-stated reasons, however, the court sustains the

entitlement decision of the special master.

Accordingly, it is hereby ORDERED that:

(1) Petitioners’ motion for review, filed as ECF No. 114 (memorandum) and

ECF No. 115 (motion), is DENIED;

(2) The August 30, 2019 decision of the special master, ECF No. 111, is

SUSTAINED;

(3) The clerk’s office is directed to ENTER final judgment in accordance

with the special master’s August 30, 2019 decision, ECF No. 111; and

10

(4) The parties shall separately FILE any proposed redactions to this opinion,

with the text to be redacted clearly blacked out, on or before January 21,

2020.

IT IS SO ORDERED.

s/Patricia E. Campbell-Smith

PATRICIA E. CAMPBELL-SMITH

Judge

11