R.K. v. the Secretary of Health and Human Services

In the United States Court of Federal

Claims

OFFICE OF SPECIAL MASTERS

No. 03-0632V

Originally filed September 28, 2015

Refiled in redacted form May 23, 2016

For Publication

*******************************************************

*

R.K, on behalf of A.K., a minor, * Autism; OAP;

* Compelling Expert Evidence;

Petitioners, * Judicial Estoppel;

v. * Filings After Closure of Record;

* Newly Discovered Evidence

SECRETARY OF THE DEPARTMENT *

OF HEALTH AND HUMAN SERVICES, *

*

Respondent. *

*

*******************************************************

John F. McHugh, New York, N.Y. for petitioners.

Heather L. Pearlman, U.S. Department of Justice, Washington, DC, for respondent.

RULING ON MOTIONS1

Vowell, Special Master:

This ruling resolves all outstanding motions. It also provides a written rationale

for rulings issued summarily as this case proceeded to and through a causation hearing.

In summary, I deny: (1) a motion to compel a non-treating physician to testify or produce

documents; (2) a motion to apply judicial estoppel with regard to causation; (3) the

admission of an expert report from another Vaccine Act case; and (4) a motion to strike

the testimony of one of respondent’s witnesses. I also address two motions that are

now moot. I grant the motion to admit a number of medical journal articles filed long

after the evidentiary record closed, but only because they are largely cumulative and

engaging in the analysis necessary to exclude them would unnecessarily prolong the

resolution of this case.

1 [ * * * *This Ruling was originally issued on September 28, 2015. In this public Ruling, the family name of

the petitioners has been redacted pursuant to their request. In addition certain matter improperly filed by the

petitioners has also been redacted, upon the instructions of Special Master Vowell, from pp. 26, 27, and 32.

See Order filed on Dec. 2, 2015.]

1

I. Procedural History.

The convoluted procedural history of this case is set forth in some detail, as it

places the resolution of the outstanding motions in context. It will be incorporated by

reference in the causation decision that follows my ruling on these issues.

A. The Initial Petition.

On March 24, 2003, petitioners [ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *

* * * * * * ] filed a “Short-Form Petition for Vaccine Compensation” under the National

Childhood Vaccine Injury Act2 [“Vaccine Act”] on behalf of their son, A.K. Such petitions,

authorized by Autism General Order #1,3 alleged in a summarized fashion that the

vaccinee has a disorder on the autism spectrum. By filing a short form petition, they opted

into the Omnibus Autism Proceeding [“OAP”], and their case was stayed while discovery

regarding general causation issues was conducted.4

B. The OAP.

Beginning in 1997, but peaking numerically in 2002-03, thousands of petitions

were filed alleging either that the measles, mumps, and rubella [“MMR”] vaccine or

thimerosal, an ethyl mercury preservative used in multi-dose vials of many vaccines,

caused ASD. The sheer volume of petitions filed—more than 1,300 new petitions in

2002 alone—led to the creation of the OAP.5 Omnibus programs had been used

2The National Vaccine Injury Compensation Program comprises Part 2 of the National Childhood

Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§

300aa-10 et seq. (2012). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of the

Vaccine Act.

3 By electing to file a Short-Form Autism Petition for Vaccine Compensation, petitioners alleged that:

As a direct result of one or more vaccinations covered under the National Vaccine Injury

Compensation Program, the vaccinee in question has developed a neurodevelopmental

disorder, consisting of an Autism Spectrum Disorder or a similar disorder. This disorder

was caused by a measles-mumps-rubella (MMR) vaccination; by the “thimerosal”

ingredient in certain Diphtheria-Tetanus-Pertussis (DTP), Diphtheria-Tetanus-acellular

Pertussis (DTaP), hepatitis B, and Hemophilus Influenza Type B (Hib) vaccinations; or by

some combination of the two.

Autism General Order #1, 2002 WL 31696785 (Fed. Cl. Spec. Mstr. July 3, 2002), Exhibit A, Master

Autism Petition for Vaccine Compensation at 2 (found at 2002 WL 31696785, 2002 U.S. Claims LEXIS

365, or http://www.uscfc.uscourts.gov/sites/default/files/autism/Autism+General+Order1.pdf) (last visited

on July 27, 2015). In filing a short-form petition, petitioner joined the Omnibus Autism Program [“OAP”],

explained in more detail, infra.

4 See Autism General Order #1, 2002 WL 31696785, at *5-7 (indicating claims filed using the short form

petition will be included in the OAP and automatically stayed while litigation on general causation issues is

conducted); see also Notice, issued Apr. 9, 2003, at 1 (describing the OAP as “a general inquiry by the

Office of Special Masters (“OSM”) regarding the possible causal relationship between certain vaccinations

. . . and autistic spectrum disorders or similar neurodevelopmental disorders.”).

5See Autism General Order #1. It is impossible to determine precisely how many petitions alleging

vaccine causation of autism were filed in the OAP, as the nature of suit codes used to track Vaccine Act

cases do not contain a code for autism or similar neurodevelopmental disorders. Estimates range from

2

previously in Vaccine Act cases to make causation determinations in groups of cases

alleging that a particular vaccine caused a specific injury, but the OAP was, by far, the

largest grouping of similar cases.6

Following a series of meetings with an informal advisory committee (comprised of

petitioners’ counsel representing many of the Program claimants and legal and medical

representatives of the Secretary of Health and Human Services), the Office of Special

Masters [“OSM”] adopted a plan that would allow a period of discovery, followed by the

selection and litigation of test cases on the theories of causation presented. Autism

General Order #1 at 2-3. The conclusions reached on general causation and the

evidence adduced in the test cases would then be used to resolve the remaining claims.

Id. at 3. Those who had already filed petitions were allowed to “opt in” or “opt out” of the

proceedings, and future claimants could automatically “opt in” by filing the short form

petition included as Attachment B to Autism General Order #1. Id. at *6-8.

Attorneys representing petitioners created the Petitioners’ Steering Committee

[“PSC”] to coordinate the OAP litigation. The PSC acknowledged that there was

insufficient evidence at the time the OAP was created to prove vaccine causation, but

averred that such evidence could be found through discovery and ongoing scientific

investigations. Petitioners sought and received an extended period of delay to conduct

discovery and prepare to litigate the test cases.

Nearly five years after the OAP was created, litigation in the test cases began,

with the PSC presenting two different theories on the causation of ASD in two sets of

test cases. The first alleged that thimerosal-containing vaccines and the MMR vaccine,

in combination, could cause ASD (Theory 1). The second alleged that thimerosal-

containing vaccines could cause ASD (Theory 2). In accordance with the intent that

OAP test case evidence be made available to assist with the resolution of the remaining

OAP cases, the evidence (including expert reports, transcripts of testimony, trial

presentation materials and trial exhibits, and lists of the medical journals and other

documents filed by the parties) was posted on the Court of Federal Claims website.7

Decisions in each of the three Theory 1 test cases, which were tried in 2007,

rejected petitioners’ causation theories. Cedillo v. Sec’y, HHS, No. 98-916V, 2009 WL

331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 89 Fed. Cl. 158 (2009), aff’d, 617

F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec’y, HHS, No. 03-654V, 2009 WL 332306

(Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 473 (2009), aff’d, 604 F.3d 1343

5,400 to over 6,000 cases, with the latter number including cases filed after the initial test case hearing

dates were announced.

6See Hennessey v. Sec’y, HHS, No. 01-190V, 2009 WL 1709053 (Fed. Cl. Spec. Mstr. May 29, 2009),

aff’d, 91 Fed. Cl. 126 (2010) (discussing the different types of omnibus proceedings conducted in the

Vaccine Program).

7See http://www.uscfc.uscourts.gov/docket-omnibus-autism-proceeding (last visited on September 17,

2015). The parties in the test cases all filed explicit written consent to make these materials publicly

available. See, e.g., Mead v. Sec’y, HHS, No. 03-215V, 2010 WL 892248, at *1 n.1 (Fed. Cl. Spec. Mstr.

Mar. 12, 2010) (referencing petitioners’ and respondent’s written consent in that case).

3

(Fed. Cir. 2010); Snyder v. Sec’y, HHS, No. 01-162, 2009 WL 332044, aff’d, 88 Fed. Cl.

706 (2009).8

Decisions in the three Theory 2 test cases, which were tried in 2008, also

rejected the causation theory presented. Petitioners did not seek review of the special

masters’ decisions. Dwyer v. Sec’y, HHS, No. 03-1202V, 2010 WL 892250 (Fed. Cl.

Spec. Mstr. Mar. 12, 2010); King v. Sec’y, HHS, No. 03-584V, 2010 WL 892296 (Fed.

Cl. Spec. Mstr. Mar. 12, 2010); Mead, 2010 WL 892248.

An impressive body of medical and scientific evidence was adduced in the OAP

test cases, with the three special masters who heard this evidence finding that the issue

of vaccine causation was not a close call. See e.g., King, 2010 WL 892296, at *90;

Snyder, 2009 WL 332044, at *198. Each of the three special masters independently

determined that the medical theories advanced were not reliable and that the test case

petitioners had failed to produce preponderant evidence of causation. The OAP test

case litigation concluded in 2010, with the last Federal Circuit decision affirming the

dismissal of the final Theory 1 test case.9

C. Test Case for Theory 2 Litigation.

This case was reassigned to me on December 18, 2007, when the autism docket,

handled from the beginning of the OAP by Special Master Hastings, was divided among

three special masters in anticipation of the test case hearings. In early 2008, the PSC

identified A.K.’s case as one of the three Theory 2 test cases. See Autism Update,

issued in the OAP docket on Jan. 17, 2008, at 2-3.10 Mr. Thomas Powers, a member of

the executive committee of the PSC, substituted as attorney of record, vice Steven

Tannenbaum. See PSC Roster, filed in the OAP docket on Mar. 9, 2007; Motion to

Substitute Attorney, filed Jan. 8, 2008 (granted the same day).

Over the next three months, the PSC filed expert reports addressing general

causation under Theory 2 in the OAP docket and in the evidentiary record of this case.11

The expert report of Dr. Elizabeth Mumper was submitted in support of both general

8 Petitioners did not appeal the Court of Federal Claims decision in Snyder to the Federal Circuit.

9 Cedillo v. Sec’y, HHS, 617 F.3d 1328 (Fed. Cir. 2010).

10Throughout this ruling, I occasionally reference documents issued or filed in the OAP docket. Such

documents will be specifically identified as a part of the OAP docket. Absent such identification, all other

references are to documents appearing on the docket of this case.

11 Expert reports were filed in the OAP docket in late 2007 and early 2008 from Drs. Sander Greenland,

Richard Deth, and Vasken Aposhian. These same reports were filed in the evidentiary record in this case

in early 2008. See Petitioners’ Exhibits [“Pet. Exs.”] 22-24. Although these reports are part of the

evidentiary record in this case, only Dr. Deth’s has clear relevance to the causation theory ultimately

presented in this case. In essence, Dr. Deth’s opinion in the Theory 2 test cases was much the same as

his theory here. Many of the slides he used to illustrate his testimony in this case were virtually identical to

the slides he used to illustrate his test case testimony.

4

causation and causation in A.K.’s case.12

Respondent also filed expert reports and curriculum vitae [“CVs”] from multiple

experts, some addressing ASD in general and others addressing general causation with

respect to Theory 2 in the evidentiary record of this case. See Respondent’s Exhibits

[“Res. Exs.”] G-KK (CVs and expert reports from 15 experts).13 Additionally, she filed

medical literature specifically focused on causation in this case. See Res. Exs. A-F.14

During this same time period, petitioners also filed medical and educational

records. See, e.g., Pet. Exs. 2-21, 25-30.

D. Petitioners’ Motion to Withdraw as a Test Case and from the OAP.

On April 10, 2008, approximately a month before Theory 2 test case hearings

were scheduled to begin on May 12, 2008, petitioners filed a motion to withdraw A.K.’s

case as a test case. Petitioners explained that they were not abandoning the theory

“that thimerosal-containing vaccines (TCVs) were a substantial contributing cause of

[A.K.’s] autistic symptoms” but wanted the opportunity “to develop and present evidence

of additional and alternative causative factors.” Motion, filed Apr. 10, 2008, at ¶ 1 (ECF

No. 40).15 Petitioners also asked to withdraw from the OAP “in order to proceed to an

individual hearing on compensation.” Id. at ¶ 2. Respondent did not object and, as

Autism General Order #1 indicated that any petitioner could ask to have his or her case

heard individually at any time, I granted petitioners’ motion. See Order, filed Apr. 15,

2008 (ECF No. 41); see also Autism General Order #1 at 8.

12Doctor Mumper’s expert report was filed in the evidentiary record of this case on January 22, 2008.

See Pet. Ex. 1. Although Dr. Mumper’s expert report was filed in the OAP docket on January 8, 2008, it

was subsequently withdrawn. At the digitally recorded status conference on Apr. 9, 2013, petitioners

indicated that they did not intend to rely on Dr. Mumper’s report and requested that I strike it. I orally

granted their request. See audio recording at 2:42-44.

13Although respondent later consented to the disclosure of the majority of these expert reports on the

court’s website (see Respondent’s Consent, filed in the OAP docket on Feb. 2, 2009), the expert reports

specific to this case were never filed in the OAP docket.

14 The medical literature filed during the period when this was one of the OAP test cases was not filed

directly into the OAP docket, but it was included on the parties’ “Master Lists.” These lists were created in

the Theory 2 test cases to avoid a problem that surfaced in the Theory 1 test cases. In the Theory 1

cases, multiple copies of the same medical journal article were filed and witnesses and counsel referred

to the same documents by different exhibit numbers, causing confusion. In the Theory 2 test cases, the

master lists were intended to comprise all of the medical literature filed by petitioners (Petitioners’ Master

List [“PML”]) and respondent (Respondent’s Master List [“RML”]). As new expert reports were filed that

referenced medical or scientific literature, that literature was added to and assigned exhibit numbers on

the master lists. See Order, issued Dec. 12, 2007 in the OAP docket, at 1. If an article appeared on

petitioner’s list, respondent was not required to include that article on her list, and vice versa. Id. at 1 n.1.

Respondent’s Exs. A-F in this case appeared as RML 32, 111, 325, 509 and PML 46, 93 on the OAP

docket’s master lists. The RML journal articles were filed into the record of this case via a CD containing

them. ECF No. 23.

15Because there are more than 300 docket entries in this case, some of which were filed on the same

dates, I will use the ECF docket number in most citations to identify the specific filing involved.

5

When requesting that their case be withdrawn as a Theory 2 test case,

petitioners also requested that any case-specific material be withdrawn from the

publically-available OAP docket. Motion, filed Apr. 10, 2008, ¶ 3 (ECF No. 40). Thus,

Dr. Mumper’s expert report was withdrawn from the OAP docket, but remained in the

evidentiary record in this case until petitioners’ request to withdraw it prior to the

hearing. See January 8, 2008 Entry on OAP Docket (indicating it was no longer

appropriate to post the expert report containing case-specific information on the court’s

website after the case was withdrawn as a test case).

Several months later (and after the test case hearings concluded), respondent

asked to withdraw the CVs and expert reports of two of her experts because she

determined their testimony would not be needed in the OAP Theory 2 cases.16

Respondent also requested that I remove them from the docket of this case. I granted

respondent’s request. See Order, issued July 29, 2008 (ECF No. 48). The CVs and

expert reports for the other thirteen experts remained in the evidentiary record for this

case.

In a later-filed exhibit list, petitioners failed to include any of their OAP expert

reports. See Exhibit List, filed Apr. 13, 2013, at 1-2 (ECF No. 234) (listing Dr. Mumper’s

report as withdrawn and indicating “Not used for filing” for the exhibit numbers (22-24)

used to designate the other OAP expert reports). The only OAP report that they had

requested to strike was that of Dr. Mumper, and I had granted that request at the

digitally recorded status conference held on April 9, 2013 (see 2:43). The only other

expert reports withdrawn from the evidentiary record in this case with leave of court

were the two reports and CVs withdrawn by respondent in July 2008. Thus, the expert

reports for Drs. Deth, Greenland, and Aposhian remain part of the record of this case.

E. Proceeding as an Individual Case.

1. Proceeding Without Retained Counsel.

On May 22, 2008, [A.K.’s father] was substituted for Mr. Powers as the

attorney of record for his son.17 [A.K.’s father] represented that he entered an

16 Respondent sought to withdraw the CV and expert report of Dr. Thomas Clarkson (Res. Exs. L, Z) and

of Dr. Laszlo Magos (Res. Exs. K, Y). See Motion, filed July 8, 2008. Respondent withdrew these expert

reports from the OAP proceedings in order to obviate the need for an additional hearing session in the

Theory 2 test cases, as petitioners had requested the opportunity to question both experts in person and

they did not appear as witnesses at the test case hearing. See Order, issued in the OAP docket on July

3, 2008, at 2.

17[A.K’s father] is an attorney who has represented more than 100 Vaccine Act petitioners on claims that

vaccines caused autism spectrum disorders, as well as petitioners in other types of vaccine injury claims.

A.K.’s case was originally filed by Steven Tannenbaum, who was replaced by PSC Executive Committee

member Thomas Powers. After petitioners withdrew as a test case, Mr. Powers withdrew from

representation. For about 19 months, [A.K.’s father] represented himself, his wife, and his son, before Mr.

John McHugh entered an appearance. Although [A.K.’s father] was represented by Mr. John McHugh

and Ms. Helen Sturm at the causation hearing, [A.K.’s father] remained actively involved in the

presentation of his son’s case (see, e.g., Transcript [“Tr.”] at 139, 261-62, 1386, 1389, 1492, 1495, 1515)

and occasionally attempted to interpose objections (see, e.g., Tr. at 326).

6

appearance to facilitate communication with the court, but that he was actively seeking

another attorney to pursue A.K.’s claim. See Status Report, filed July 1, 2008 (ECF No.

45). Although respondent’s counsel later objected to [A.K.’s father’s] appearance,

arguing that the case should be designated as pro se, I allowed [A.K.’s father] to

remain attorney of record while he searched for representation. Order, issued Nov. 7,

2008, at 1 (ECF No. 50).18

For about 19 months, [A.K.’s father] attempted to find new counsel to represent

A.K. He filed numerous status reports requesting enlargements of time and updating

me on his progress (or lack thereof). See, e.g., Status Report, filed Aug. 4, 2009 (ECF

No. 61). He filed medical records as they were created or became available. See Pet.

Exs. 31-33 (ECF Nos. 51-52, 65). Other than the filing of medical records, petitioners

did little to advance their claim during the period in which [A.K.’s father] was attorney of

record.

I continued to press [A.K.’s father] to move his son’s case toward resolution

during this period, noting that when he withdrew from the OAP and indicated a desire to

proceed as an individual case, he was no longer able to claim the benefit of being in the

OAP “holding pattern” to avoid his obligation to prosecute his son’s claim. Perhaps in

frustration with my insistence that petitioners either needed to find substitute counsel or

otherwise prosecute A.K.’s case themselves, [A.K.’s father] voiced a desire to return the

case to the OAP during a status conference on November 3, 2008. I directed

petitioners “to file a written motion requesting their case be redesignated as an OAP

case as soon as possible.” See Order, issued Nov. 7, 2008, at 1 (ECF No. 50).

Petitioners never filed that motion.

2. Securing Representation.

On January 5, 2010,19 John F. McHugh filed a motion to be substituted as

counsel in this case, and I granted the motion on January 7, 2010. However, the glacial

pace of progress toward a causation hearing continued for many months thereafter. Mr.

McHugh’s representation has been marked with missed deadlines, repeated requests

for delays, late filings, and difficulties in properly designating and filing exhibits. His

failure to meet deadlines nearly cost petitioners the opportunity to fully litigate their son’s

claim.

In the first two months Mr. McHugh represented petitioners, he missed both

deadlines set for status reports informing me that he had met with petitioners and was

ready to discuss the way ahead in this case.20

18The practical reason to allow [A.K.’s father] to enter an appearance as attorney of record was to

continue to allow documents to be filed electronically. [A.K.’s father] was (and is) an attorney admitted

to the bar of the Court of Federal Claims. I did caution him, however, that it was unlikely he could be

paid attorney fees for his work on his son’s case.

19 Mr. McHugh filed a defective motion to substitute as counsel on December 2, 2009 (ECF No. 73).

20

I had an initial status conference with Mr. McHugh more than two weeks after his notice of appearance

was properly filed. See Order, issued Jan. 20, 2010, at 1 (ECF No. 76). He informed me he had not yet

7

Between January and August 2010, petitioners’ counsel 21 did very little to

advance the case. Although he reported in March 2010 that he had retained an expert22

who was reviewing the case and expected the expert to produce a report in about two to

two and one half months (Status Report, filed Mar. 5, 2010 (ECF No. 78)), Dr.

Kinsbourne’s very cursory report was not filed until October 26, 2010 (ECF No. 100).

At the next status conference, held about 90 days later to allow Dr. Kinsbourne

time to prepare his expert report, petitioners indicated that they intended to file an

application for interim costs due to the significant fees involved in retaining medical

experts. See Order, issued June 8, 2010, at 1 (ECF No. 79). It became apparent

during the conference that petitioners had not filed all medical records in their

possession. See id. Thus, I ordered petitioners to file all remaining medical records by

June 18, 2010; any application for interim fees and costs by July 23, 2010; and a status

report informing me of their progress in obtaining expert reports by August 9, 2010. See

id.

Petitioners filed medical records and a notice of compliance (ECF Nos. 93, 95)

on June 16 and 17, 201023 and an out of time24 status report (ECF No. 96) on August

13, 2010. In their status report, petitioners informed me that (1) Dr. Kinsbourne was

unable to complete his expert report as he was awaiting further diagnostic tests; (2) Dr.

Kinsbourne could not specify when his expert report would be completed; and (3)

petitioners were pursuing another unnamed expert. Status Report, filed Aug. 13, 2010,

at 1-2 (ECF No. 96). Petitioners suggested that they file monthly status reports until

met with petitioners or familiarized himself with the case and estimated that he needed an additional thirty

days to do so. See id. I scheduled another status conference for February 19, 2009 and ordered

petitioners to file a status report informing me that they had met with counsel and discussed their case by

February 12, 2010. Id. Petitioners missed this deadline. On February 18, 2010, I cancelled the status

conference scheduled for February 19, 2010, ordered Mr. McHugh to obtain A.K.’s medical records and

familiarize himself with the case as soon as possible, and ordered petitioners to file a status report

indicating that Mr. McHugh was ready to proceed by March 4, 2010. See Order, issued Feb. 18, 2010

(ECF No. 77). Petitioners missed the deadline, but filed a late status report indicating that Mr. McHugh

was reviewing A.K.’s medical records and that Dr. Marcel Kinsbourne had been retained as an expert and

was reviewing the medical records as well.

21All future references to petitioners’ counsel in this ruling are to Mr. McHugh, petitioners’ attorney of

record. Ms. Helen Sturm, an attorney associated with Mr. McHugh, also appeared on behalf of

petitioners at the hearings.

22 Doctor Kinsbourne was an expert for petitioners in both the Theory 1 and 2 test cases and, as I noted

in Snyder, 2009 WL 332044, at *12, was something of a professional witness in Vaccine Act cases. He

was thus well acquainted with the medical literature pertaining to both vaccines and autism.

23 Petitioners attempted to file medical records on June 14, 2010 (ECF Nos. 84-91). However, the

records were struck as they were not properly filed and used an incorrect event code (“15 week

stipulation status report.”) On June 16, 2010, petitioners properly filed Pet. Exs. 34-36. Identical records

were filed again on June 17, 2010 (ECF Nos. 93, 95).

24Petitioners’ status report was due on August 9, 2010. Petitioners were reminded of the process used to

request additional time under Vaccine Rule 19(b) and warned that future out of time filings would be struck.

See Order, filed Aug. 18, 2010, at 1, n.1.

8

their expert reports were filed. Id. at 2.

I rejected this suggestion25 and, instead, ordered petitioners (1) to identify their

potential expert and outline the steps taken to contact the expert, (2) to file a status

report informing me when Dr. Kinsbourne had received the medical records he needed

and when his report could be filed, and (3) to inform me if Dr. Kinsbourne could not

complete his expert report in seventy-five days and, if so, to file a letter from Dr.

Kinsbourne explaining why and providing a date when his report would be completed.

Order, filed Aug. 18, 2010, at 1-2 (ECF No. 97). Petitioners failed to meet any of these

deadlines.

F. Dismissal of Petitioners’ Claim.

During the period in which [A.K.’s father] was attorney of record and while Mr.

McHugh was attempting to familiarize himself with this case, the OAP test case

decisions were issued. Thereafter, many litigants, particularly those who had

proceeded on the thimerosal theory (Theory 2), dismissed their claims. The PSC had

not sought review of the Theory 2 test case decisions by the special masters, thus

effectively concluding the OAP litigation of this theory. Many attorneys who were

representing the test case litigants were seeking to withdraw from representation, based

on their assessment that the causation theories they had pursued were no longer

viable.

Against this backdrop, petitioners’ apparent inability to find a doctor other than

Dr. Kinsbourne willing to opine or to obtain a report on causation from Dr. Kinsbourne,

coupled with the repeated missed deadlines, signaled to me that they had problems

with their case. Accordingly, after petitioners missed the deadlines set forth in my

August 18, 2010 order, I ordered them to show cause why their case should not be

dismissed for failure to prosecute and comply with court orders. See Order to Show

Cause, issued Sept. 3, 2010 (ECF No. 98). After petitioners ignored the deadline in the

show cause order, I dismissed their petition on October 13, 2010.

G. Motion for Reconsideration.

Petitioners filed a motion on October 26, 2010, asking me to reconsider my

decision dismissing their claim for insufficient proof and failure to prosecute.26 After

allowing the parties to present their arguments,27 I granted petitioners’ motion for

25 I viewed petitioners’ request to file monthly status reports as an effort to obtain more delays in the

litigation of their causation claim. More than two years after petitioners had withdrawn as an OAP test

case and indicated that they intended to proceed independently on their case, they had still not filed any

report (other than Dr. Mumper’s) that reflected a causation theory implicating vaccines as causal.

26 With their motion for reconsideration, petitioners also filed additional evidence, declarations from

[A.K.’s father, A.K.’s mother], and treating physician Dr. Marvin Boris as well as some medical literature

and the long-delayed report from Dr. Kinsbourne. See Pet. Exs. 37-56.

27See Respondent’s Response, filed Nov. 3, 2010 (ECF No.102); Petitioners’ Reply, filed Nov. 6, 2010

(ECF No. 104).

9

reconsideration. See Order, issued Nov. 12, 2010, at 2 (ECF No. 106).28 I

subsequently redacted, at petitioners’ request, portions of the order granting the motion

for reconsideration and withdrawing my dismissal decision.

H. Request for Pre-Payment of Interim Costs.

Following my withdrawal of the October 13, 2010 decision dismissing petitioners’

claim, I ordered petitioners to file a status report informing me of the date by which they

expected to file the report of their new expert, Dr. Richard Frye, and an “amended

petition clarifying their theory of causation.” Scheduling Order, issued Nov. 15, 2010, at

1 (ECF No. 107). In response, petitioners filed a motion seeking additional time to file

their amended petition, pre-approval of Dr. Frye as an expert, and interim costs in the

amount of $5,00029 to be paid as a retainer to Dr. Frye. Motion, filed Nov. 30, 2010, at 6

(ECF No. 109). On January 28, 2011, I granted the motion for additional time to file an

amended petition and awarded interim costs in the amount of $5,000.30 Decision,

issued Jan. 28, 2011. This decision was later withdrawn as moot, at 10 (ECF No. 121);

see also Order, issued Feb. 28, 2011 (ECF No. 128) (ordering the decision withdrawn)

because Dr. Frye could no longer opine or testify, based on changed employment.

I. Petitioners’ First Amended Petition.

Petitioners filed their first amended petition on February 28, 2011. First

Amended Petition (ECF No. 126).

A few weeks later, petitioners indicated they had retained Yuval Shafrir, M.D. and

requested an additional sixty days to file his report.31 Status Report, filed Mar. 9, 2011

(ECF No. 129). After petitioners filed Dr. Shafrir’s expert report,32 I ordered respondent

to file an expert report, supplemental Rule 4 report, and any evidence from the OAP

upon which she intended to rely. See Order, issued July 12, 2011. Respondent filed

28Because I granted petitioners’ motion and ordered my decision to be withdrawn, I denied as moot

petitioners’ motion (ECF No. 101) to redact portions of the October 13, 2010 decision.

29

This amount was based on an hourly rate of $500 and, thus, constituted prepayment for ten hours of

work.

30 I also ordered petitioners to file “a bill documenting the charge and payment of Dr. Frye’s retainer” by

no later than February 28, 2012 and a more detailed bill within sixty days of the filing of Dr. Frye’s expert

report. On February 7, 2011, respondent filed a motion for reconsideration which I denied. See Order,

filed Feb. 23, 2011, at 5 (ECF No. 124). However, I withdrew my decision awarding interim costs on

February 28, 2011 after petitioners informed me that Dr. Frye was no longer opining in this case. See

Order, filed Feb. 28, 2011 (ECF No. 128).

31Petitioners’ counsel reiterated this request in a status conference I held that day. Respondent did not

object to the request. See Order, issued Mar. 9, 2011 (ECF No. 130). I granted the delay requested.

32Petitioners filed Dr. Shafrir’s expert report and references on July 7, 2011. Pet. Ex. 63, Tabs 1-22 (ECF

NO. Nos. 135-141). Because they had failed to file Dr. Shafrir’s expert report as a separate attachment,

they re-filed the report and first four references on July 8, 2011. See Pet. Ex. 63, Tabs 1-4 (ECF No.

142).

10

her Rule 4 report and OAP evidence as ordered on October 10, 201133 but requested

additional time to file her expert reports. See Motion, filed Aug. 5, 2011 (ECF No. 144).

I granted respondent’s request, allowing her until November 14, 2011 to file her reports.

Order, issued Aug. 5, 2011.

Prior to respondent’s deadline, petitioners informed me that they had retained

another expert, Fran. D. Kendall, M.D. and expected to file her report in approximately

two months. See Status Report, filed Oct. 20, 2011, at 1-2 (ECF No. 147).

In November 2011, respondent filed expert reports from Gerald Raymond, M.D.,

Judith Miller, Ph.D., and Christine McCusker, M.D. Respondent also indicated she

would be filing a report from a mitochondrial disorder expert after Dr. Kendall’s report

was filed.34 In December 2011, petitioners filed Dr. Kendall’s expert report and

references. See Pet. Exs. 65-92, filed Dec. 21, 2011.

J. Preparations for Hearing.

On January 13, 2012, I held a status conference with the parties to discuss any

additional expert reports they intended to file. See Order, issued Jan. 13, 2012, at 1

(ECF No. 151). Petitioners indicated that they wanted to obtain an expert on pediatric

development and an expert on oxidative stress. I discussed dates by which the parties

should have all expert reports filed and indicated that the case should be ready for a

hearing in November 2012. Id. I ordered the parties to discuss potential hearing dates

with their experts and to propose dates for a hearing. Id.

Respondent proposed two weeks in February 2013, but petitioners failed to

convey their preferred dates. See Order, issued Feb. 2, 2012 (ECF No. 152). Once

petitioners concurred with respondent’s proposed hearing dates, I set the hearing for

February 17-27, 2013, in Washington, DC. Pre-Hearing Order, issued Feb. 3, 2012

(ECF No. 154).

On March 14, 2012, respondent filed expert reports responsive to Dr. Kendall’s

opinions from Bruce H. Cohen, M.D. and Kendall B. Wallace, Ph.D. See Res. Exs. SS-

VV.

From late February to July 2012, petitioners filed a series of status reports

detailing their efforts to find experts in the areas of oxidative stress and child

development. In June, petitioners informed me that A.K.’s pediatrician, Dr. Heddy

Zirin,35 would be testifying in this case but they still were seeking a medical expert in

33See Res. Ex. LL (ECF No.145) (testimony from several OAP witnesses explaining autism spectrum

disorders); Respondent’s Second Rule 4 Report (ECF No.146), recommending against compensation.

34I had permitted respondent to defer filing her expert reports until after Dr. Kendall’s report was filed.

Scheduling Order, issued Oct. 24, 2011, at 1 (ECF No. 148).

35Doctor Zirin never testified. Petitioners indicated at the April 9, 2013 pre-hearing status conference that

they did not intend to call her.

11

oxidative stress. Status Report, filed Jun. 1, 2012, at 1 (ECF No. 158). The following

month, petitioners informed me that Richard Deth, Ph.D. would be testifying as an

expert in oxidative stress and Mary Megson, M.D. would be testifying as a

developmental pediatrician. Status Report, filed Jul. 31, 2012, at 2 (ECF No. 160).36

Petitioners also informed me that the hearing, which had been set six months earlier,

would have to be delayed. They explained that their attorney was lead counsel in a civil

case in Nevada which the judge had “set a firm trial date” which conflicted with the

hearing date for this case.37 Id. at 1.

Ultimately, I bifurcated the hearing in this case, setting a fact hearing to take the

testimony of petitioners and treating physicians in New York City, NY on December 12-

13, 2012 and setting the entitlement hearing at which experts would testify in

Washington, DC for April 22-30, 2013. Pre-Hearing Order, issued Aug. 16, 2012, at 2

(ECF No. 166). I ordered petitioners to file all expert reports by September 14, 2012

and respondents to file all expert reports by November 13, 2012. Id.

Once again, petitioners did not file their reports by the deadline I had imposed.

Expert reports from Drs. Megson and Boris were filed on September 26, 2012 and from

Dr. Deth on October 29, 2012. See Pet. Exs. 107-108; 117, Tabs 1-55. Since I had

extended petitioners’ deadline for filing their expert reports, I adjusted respondent’s

deadline, ordering her to file all expert reports by December 13, 2012. See Order,

issued Sept. 26, 2012 (ECF No. 172).

K. The December 2012 Fact Hearing.

I ordered the parties to file their pre-hearing submissions for the fact hearing by

November 9, 2012. Pre-Hearing Order, issued Sept. 26, 2012 (ECF No. 173). At the

December 2012 hearing, I heard testimony from petitioners, [A.K.’s mother and father].38

Ms. Sturm represented petitioners at the hearing.

36 Petitioners attached CVs for Drs. Deth and Megson to their status report. See Pet. Exs. 95-96.

37 On August 1, 2012, I held a status conference to discuss the scheduling conflict. See Order, issued

Aug. 1, 2012 (ECF NO. 161). I reminded petitioners that I “deliberately set the hearing a year in advance

to give the large number of experts who are expected to testify ample time to make the necessary

arrangements in their clinical practices and research schedules to permit their presence at the hearing.”

Id. Furthermore, I “expressed my concern that petitioners’ counsel failed to inform the trial judge of the

previously set firm hearing date in this case when the jury trial date was being discussed” in the other

case. Id. I ordered the parties to file a joint status report, discussing whether the entitlement hearing

could be held from February 25, 2013 until March 5, 2013 and to determine if we could hear fact

witnesses in December 2012 or January 2013, to shorten the time needed for the entitlement hearing

itself. Id. To say I was concerned by Mr. McHugh’s cavalier disregard of the schedule in this case would

be an understatement. Juggling schedules of experts frequently delays Vaccine Act cases, and this case

had about three times the number of experts generally appearing.

38Two days prior to the hearing, petitioners informed me that due to time constraints for both Dr. Boris

and [A.K.’s mother], Dr. Boris would not be testifying at the fact hearing. Instead, he would be testifying

as both a fact and expert witness at the entitlement hearing in April 2013 in Washington, DC. Petitioners

also decided against calling Dr. Zirin. See Supplemental Pre-Hearing Order, issued Apr. 17, 2013 (ECF

No. 239).

12

During [A.K.’s mother’s] testimony, it became apparent that petitioners thought

they had filed documentation regarding A.K.’s receipt of a second dose of influenza

vaccine39 in early December 2001. Tr. at 69-70. I recessed while a copy of this record

(filed later that day as Pet. Ex. 118) was obtained. Tr. at 70-71; see Pet. Ex. 118, filed

Dec. 12, 2012 (ECF No. 188).

L. Second Request for Pre-Payment of Interim Fees and Costs.

Following the fact hearing, petitioners filed their second motion for interim costs.

Arguing that they had expended $17,000.00 litigating their claim, petitioners requested

$81,750.00 to cover costs they expected to incur during the April 2013 entitlement

hearing. Motion, filed Jan. 10, 2013, at 3-5, 11 (ECF No. 190). The parties were unable

to agree on an award of interim costs, but respondent indicated that she would not

object to an award of interim fees and costs in the amount of $30,000.00, representing

payment for attorneys’ fees. Status Report, filed Mar. 22, 2013, at 1-2 (ECF No. 209).

On March 27, 2013, based on the documentation submitted for amounts already

expended, I awarded interim costs in the amount of $24,108.12. Decision (ECF No.

215). Neither party filed a motion for review of that decision.

M. Preparation for the April 2013 Entitlement Hearing.

On February 21, 2013, I ordered the parties to file any additional exhibits and

medical literature by March 22, 2013, and pre-hearing briefs by April 8, 2013.

Respondent filed their medical literature on March 22, 2013. See Res. Exs. MM, Tabs

20-24; OO, Tabs 1-4; SS, Tabs 1-20; UU, Tabs 17-20; VV. Indicating that they would

be filing over 100 additional medical journal articles, petitioners requested an extension

of four days. Motion, filed Mar. 22, 2013, at 1 (ECF No. 210). I granted petitioners’

request but warned them that I would not consider additional literature filed after that

date. Order, issued Mar. 25, 2013, at 1 (ECF No. 214); see also Pre-Hearing Order,

issued Feb. 21, 2013, at 1 (ECF No. 199) (indicating that, absent a compelling reason, I

would not consider late filed medical literature). Petitioners filed their medical literature

on March 26, 2013.40

A few days later, petitioners filed an unpublished paper regarding the evaluation

and treatment of patients with autism and mitochondrial disorders from Dr. Richard

Kelley at the Kennedy Krieger Institute. This document was not a medical journal article

or medical record; it appeared to be a handout provided to patients or perhaps to

referring physicians. See Pet. Ex. 233, filed on Mar. 31, 2013. Because I had given

petitioners more than adequate notice that, absent a compelling reason, I would not

39At that time, children under two years of age received a split dose of vaccine, half the amount

administered to older children and adults, in two vaccinations about one month apart.

40The articles filed were labeled as exhibits 124-67, 171-209, and 211-31. Petitioners correctly noted

that exhibit numbers 169-70 and 210 had been assigned to previously filed exhibits. See Pet. Exs. 169-

70, 210, filed on Mar. 22, 2013 (ECF No. 211) (attachments to petitioners’ status report regarding interim

costs).

13

consider medical literature filed after the deadline, I ordered the exhibit struck.41 Order,

issued Apr. 9, 2013; see also audio transcript of Apr. 9 2013 status conference at 2:35

(petitioners’ counsel agreeing that the article was “not critical” and that there was no

compelling reason for the late filing).

Also on March 31, 2013, petitioners also filed a motion requesting that I issue a

subpoena to compel an expert in another case to produce his expert report from that

case and any other material or information “deem[ed] appropriate to accomplish the

purposes of the Vaccine Act and justice.” Motion to Issue Subpoena, filed Mar. 31,

2013, at 7 (ECF No. 216). I ordered respondent to file a response to petitioners’ motion

by April 8, 2013, reiterating that the parties’ pre-hearing submissions were due on the

same date. Order, issued Apr. 1, 2013 (ECF No. 218). Respondent filed her response

(see ECF No. 224). I orally denied the motion. Apr. 9, 2013 status conference at 2:33.

On April 1, 2013, just three weeks prior to the start date for the causation

hearing, petitioners requested leave of court to file a second amended petition. Motion,

filed Apr. 1, 2013, at 1 (ECF No. 219). Petitioners attached the proposed amended

petition as Pet. Ex. 234. I granted this motion and the amended petition [“2d Amend.

Petition”] was filed on April 17, 2013 (see ECF No. 237); see also Apr. 9, 2013 status

conference at 2:33-34 (permitting filing of the amended petition, but noting that

petitioners were now alleging as causal vaccines that were not on the Vaccine Injury

Table at the time their short-form petition was filed).

Petitioners then requested leave of court to file a recently published medical

journal article.42 Because the article was not available until January 25, 2013, I granted

petitioners’ motion. Petitioners filed the article on April 17, 2013. See Pet. Ex. 235

(ECF No. 238); see also Apr. 9, 2013 status conference at 2:36-38 (permitting the late

filing, despite the earlier on-line availability of the article).

The parties filed their pre-hearing submissions on April 8, 2013. ECF Nos. 225-

26, 228-29. Additionally, petitioners filed another document (titled as a motion in limine)

containing numerous requests for relief. See Motions in Limine, filed Apr. 8, 2013 (ECF

No. 227). Because the deadline for respondent’s response to petitioners’ motions fell

on the first day of the planned hearing, I extended respondent’s deadline until two

weeks after the hearing was scheduled to conclude. Order filed Apr. 9, 2013. I discuss

and rule on these motions in Section II, below.

I held a status conference on April 9, 2013 to discuss preparations for the

upcoming hearing. Following the call, respondent filed the updated CV for Dr. Raymond

(see Res. Ex. NN, filed Apr. 10, 2013 (ECF No. 231)) and a status report listing the

videotape clips she intended to use at the hearing (see Status Report, filed Apr. 12,

41 I reviewed the document prior to ordering it struck.

42 When petitioners originally filed their motion, they incorrectly used the exhibit number already assigned

to their second amended petition (Pet. Ex. 234). See Motion, filed Apr. 4, 2013 (ECF No. 222). Thus,

petitioners later asked that I strike that motion and allow the article to be filed out of time as exhibit 235.

Motion, filed Apr. 9, 2013, at 3 (ECF No. 230).

14

2013 (ECF No. 232)). Petitioners filed the redacted videotape footage they intended to

use at the hearing. See Notice filed Apr. 12, 2013 (ECF No. 233) (listing Pet. Exs. 236

and 236A).43 Petitioners also filed the declaration of the technician who prepared the

redacted videotape footage. See Pet. Ex. 237, filed Apr. 18, 2013 (ECF No. 241).

N. The April 2013 Entitlement Hearing.

Two days before the entitlement hearing, petitioners requested leave to file out of

time a recently published article related to the research being conducted by one of their

experts, Dr. Deth. Motion, filed Apr. 20, 2013 (ECF No. 243) (requesting to file Pet.

Exs. 238 (article) and 238A (article’s abstract)). I granted that request.

During the second day of the hearing, petitioners filed copies of the slides which

Dr. Deth would be referencing while testifying and another recently published article

upon which he intended to rely. See Pet. Exs. 239 and 240, filed Apr. 24, 2013 (ECF

Nos. 244 and 245). The evening before the last day of the hearing, petitioners filed a

motion for leave to file out of time another recently published article. See Motion, filed

Apr. 28, 2013 (ECF No. 255) (requesting to file Pet. Ex. 241).44

Respondent filed the updated CV of Dr. Cohen and copies of the presentations

used by Drs. Jones, Johnson, and Raymond. See Res. Exs. TT, Tab 1; GGG; HHH; III.

O. Post Hearing Motions and Briefs.

Following the entitlement hearing, I ordered petitioners to file the medical

literature referenced at hearing indicating that I “may or may not consider these articles

but must see the entire article before making that determination.” Order, issued May 1,

2013, at 1 (ECF No. 257). This order was necessary because Dr. Deth cited many

medical journal articles not previously filed on the PowerPoint slides he used during his

testimony. I also allowed respondent to respond to the late-filed exhibits. Id.

Because petitioners informed me they had found an expert in child development

to replace Dr. Megson, who had been unable to testify due to illness, and estimated

they could file a report from their new expert within 60 days, I set a deadline for the

replacement expert’s report and a deadline 30 days thereafter for a written response

43 Petitioners filed the notice of intent to file this video footage (on a computer hard disk) on April 12, 2013.

Notice (ECF No. 233). However, the docket did not reflect receipt of the hard disk and no copy of

it was received at OSM from the Clerk of Court. The original court file in this case did not contain a hard

disk. Nevertheless, I was able to view the videos discussed at the hearing. In anticipation of issuing this

ruling and the entitlement decision in this case, I ordered petitioners to file another copy of the video clips

shown at the hearing to ensure that the record is complete. See Order, issued Aug. 20, 2015 (ECF No.

315). Based on the information supplied by petitioners, it appears that the hard disk was received, but

somehow misplaced by the Clerk’s Office. See Status Report, filed Aug. 20, 2015 (ECF No. 317).

Pursuant to my order, petitioners provided another copy of the videos (this time on a jump drive) on Aug.

21, 2015. See Notice, filed Aug. 20, 2015 (ECF No. 318).

44Petitioners originally filed their motion on April 27, 2013 but asked that I strike that motion on April 28,

2013. See ECF No. Nos. 253 and 254.

15

from respondent. Order, issued May 1, 2013, at 1-2 (ECF No. 257). Petitioner later

filed a status report indicating they “w[ould] not be submitting another expert’s report

and will rely upon those submitted.” Status Report, filed July 1, 2013 (ECF No. 272).

They then asked that Dr. Megson be allowed to testify by video in late summer or fall

(see Status Report, filed July 17, 2013, at 1 (ECF No. 274)) but changed their minds

approximately two weeks later, citing excessive costs and indicating they would rely on

Dr. Megson’s expert report (see Status Report, filed July 30, 2013 (ECF No. 275),

without the need for further testimony.

Finally, I reiterated my instructions at the close of the hearing that I would order

the parties to file simultaneous post hearing briefs once the record was complete and

reminded respondent that her deadline to respond to petitioners’ motions in limine was

May 14, 2013. Order, issued May 1, 2013, at 1-2 (ECF No. 257). Respondent filed her

response on May 13, 2013 (see ECF No. 258).

On May 31, 2013, petitioners filed the medical literature referenced in Dr. Deth’s

PowerPoint presentation but, instead of assigning each article a new exhibit number,

petitioners labeled them as references to the slide in which the article was mentioned.

See (ECF No. 260-262). I ordered petitioners to assign each article its own exhibit

number and to file an updated exhibit list reflecting the new exhibit numbers. Order,

issued June 6, 2013, at 1-2. Petitioners filed their updated exhibit list assigning exhibit

numbers 242-266 to the medical literature on June 25, 2013. See ECF No. 271.

Less than one month later, petitioners sought in a status report to file yet another

article out of time. They assigned the article an exhibit number which had been used

previously (Pet. Ex. 237). Status Report, filed July 17, 2013 (ECF No. 274). Because

petitioners later filed an appropriate motion, albeit out of time, to file the same article,

correctly labeled as exhibit 273, (see Motion, filed Apr. 24, 2013 (ECF No. 293)),

petitioners’ July 17, 2013 request via status report to permit the late filing of medical

literature is moot.

In August 2013, respondent filed the supplemental report of Dr. Johnson

pertaining to the medical literature, previously unfiled, that Dr. Deth had referenced in

his slide presentation at the hearing. See Res. Ex. JJJ. At that point, I filed Court

Exhibit [“Court Ex.”] I, and solicited any comments, supplemental expert reports or

arguments concerning the filing.45 Order, issued Sept. 3, 2013 (ECF No. 277). I also

set deadlines for filing any additional evidence in this case. Post Hearing Order, issued

Sept. 9, 2013, at (ECF No. 278). Respondent filed supplemental expert reports from

Drs. Cohen and Wallace responding to the Wolf & Smeitink article, Court Ex. I. See

Res Exs. KKK, LLL, filed Sept. 30, 2013 (ECF No. 279). Petitioners filed a

supplemental expert report from Dr. Kendall responding to Court Ex. I, but again re-

45N. Wolf & J. Smeitink, Mitochondrial Disorders: A proposal for consensus diagnostic criteria in infants

and children, NEUROL. 59: 1402-06 (2002) [hereinafter “Wolf & Smeitink, Court Ex. I”]. Strictly speaking, it

was unnecessary to file this document as a court exhibit, as it had been filed by respondent as Res. Exs.

SS, Tab 19 and UU, Tab 15. However, I wanted both parties to address the diagnostic criteria specific to

children set forth in the article and in the supplemental materials referenced in the article.

16

used an exhibit number. See Pet. Ex. 238, filed Oct. 3, 2013 (ECF No. 280).

Petitioners also filed a written response from Dr. Deth to comments made by Dr.

Johnson, once again assigning the response an exhibit number which had been

previously used. See Pet. Ex. 239, filed Oct. 8, 2013 (ECF No. 281). Later, on January

16, 2014, petitioners moved to strike and replace Dr. Kendall’s supplemental expert

report, labeling it as Pet. Ex. 269 (see ECF No. 287). Thus, although there are no

longer two exhibits labeled Pet. Ex. 238, there are still two exhibits labeled Pet. Ex. 239.

On November 15, 2013, I indicated that the evidentiary record was complete and

ordered the parties to file post hearing briefs. Post Hearing Order (ECF No. 282).

Following my order, petitioners attempted to file four more articles out of time.

See Motion, filed Jan. 14, 2014 (ECF No. 284) (requesting to file Pet. Ex. 240);46

Motion, filed Apr. 24, 2014 (ECF No. 293) (requesting to file Pet. Exs. 271-73).

Because I had ordered the evidentiary record closed in my November 15, 2013 order, I

denied both of petitioners’ motions. Order, issued Apr. 28, 2014, at 1-2 (ECF No. 294).

After multiple extensions of time, the parties filed their post hearing briefs on May

5, 2014. Petitioners attached a table setting forth multiple test results to their brief. See

Pet. Ex. 274. Petitioners also requested that I strike the testimony of Dr. Miller, one of

respondent’s experts on autism diagnosis. Pet. Post-Hearing Memo, at 34 (ECF No.

297). I respond to that request in the rulings below.

The parties filed responses to the opposing party’s brief on June 16, 2014. To

their response, petitioners attached new three exhibits. See Pet. Ex. 274-275 and 279

(ECF No. 302). Petitioners again used an exhibit number (274) which had previously

been used. The exhibit filed on June 16, 2014 is a notice of a funding opportunity for

research regarding autism. See Pet. Ex. 274, filed June 16, 2015 (ECF No. 302).

After the filing of the post-hearing reply briefs, petitioners again requested to file

out of time the four exhibits I had disallowed in April 2014 (see Order, issued Apr. 24,

2014, ECF No. 294), the three exhibits attached to their response to respondent’s post

hearing brief, and six additional articles. Motion, filed June 17, 2013 (ECF No. 303;

Motion, filed June 26, 2014 (ECF No. 306).47 In July 2014, respondent filed a response

to petitioners’ motions and petitioners then filed a reply.

46Petitioners originally filed an “unprocessed copy of Exhibit 240” but attempted to correct their mistake in

an errata filed that same day (Errata, filed Jan 14, 2014 (ECF No. 285)) and then made a motion to strike

(Motion, filed Jan. 14, 2014 (ECF No. 286)). Another article labeled Pet. Ex. 24 (Wong) had been used

during the hearing. Petitioners eventually relabeled the Rose article (the subject of the abortive filings in

January 2014) as Pet. Ex. 270.

47

Originally, [A.K.’s father] filed this motion. See Motion, filed June 26, 2014 (ECF No. 305). Since he

was not the attorney of record, I struck his filing. See Non-pdf Order, filed June 27, 2014.

17

II. Rulings on Outstanding Motions.

A. Overview.

With regard to most of the motions filed prior to the hearing in this case, I either

ruled orally or deferred ruling until I could consider the proffered evidence in context of

the testimony and other evidence properly filed. In orally denying the motion to

subpoena an expert witness, see audio transcript at 2:33 (Apr. 9, 2013 status

conference), I indicated that I would issue a written ruling at a later time.

Although petitioners characterized their motions as motions in limine, most were

not motions to preclude the use of evidence. See BLACK'S LAW DICTIONARY (10th ed.

2014) (defining a motion in limine as a “pretrial request that certain inadmissible

evidence not be referred to or offered at trial.”). Rather, petitioners sought many

different types of relief. Most of these motions were filed on April 8, 2013, at a time

when both respondent’s counsel and I were engaged in preparation for a lengthy

hearing involving multiple experts. Petitioners had also just filed a new petition

“clarifying” the theory of causation, many of the medical journal articles they filed had

not been discussed by their experts, and there were extensive medical records in this

case. Given the deluge of filings and the imminent hearing, I deferred ruling on most

motions until after the hearing, when respondent would have adequate time to consider

and respond and I could consider the issues in the context of the evidence adduced at

the hearing. See generally, recording of status conference held April 9, 2013, at 2:32.

Petitioners’ penchant for filing multiple motions requesting the same relief and

their impaired ability to properly file exhibits have needlessly complicated the docket in

this case. Sorting out the exhibit numbers alone has consumed considerable time and

effort. During an April 9, 2013 status conference, I told the parties that a ruling on

petitioners’ motions would be issued at the time of or before issuing a decision on

causation. Audio Tr. at 2:32-33. As reflected below, their attempts to drag what

happened in another Vaccine Act case—one decided and compensated as a Table

injury—into the resolution of this causation in fact case, has fruitlessly complicated the

resolution of their motions, as I must address the actual procedural history for both the

instant case and the Poling case, No. 02-1466. What actually happened in Poling is far

different from the Poling case they describe.

Petitioners’ counsel did not appear to understand that closing the record (which

was not done until long after the hearing) meant that no further evidence should be filed,

absent truly extraordinary circumstances. Petitioners never adequately explained in any

of their requests to file medical journal articles (and often, not even newly published

articles) why reopening the record to consider this evidence was truly necessary to a fair

trial or a just result. I cannot identify even one of the articles filed after the evidence

closed that was not either cumulative of the evidence already presented or which was

truly late-breaking and highly significant. The need to read, re-read, and compare late-

filed journal articles to the evidence already filed (which included at least 100 journal

articles that no expert ever mentioned in a report or testimony) has materially

18

contributed to the delay in issuing a decision in their son’s case. As respondent has

noted, perhaps that was petitioners’ intent, in the vain hope that more delay would work

in their favor.

I now issue the written rulings on all of petitioners’ outstanding motions and

clarify why some of the filed motions are now moot.

B. Resolving Issues Surrounding the Poling Case.

The motion to subpoena, depose, or otherwise compel the expert testimony of

Dr. Andrew Zimmerman and the motion to compel respondent to concede the medical

theory advanced by petitioners are both bound up in the issues presented in another

OAP case, one brought by Dr. Jon Poling and his wife on behalf of their minor

daughter.48 Understanding the background of this other, widely publicized case is

critical to placing petitioners’ motions in the case at bar in context.

1. Background and History of the Poling Case.

Petitioners in this case (and at least one other case)49 have formally argued that

respondent’s concession of entitlement to compensation in the Poling case, No. 02-

1466,50 renders the government unable to contest entitlement in theirs. Their claim that

respondent should be judicially estopped from challenging their causation theory stems

from the Poling case, which was settled in 2010 but conceded by respondent in 2008.

The facts of the Poling case and its relationship to this one are drawn from two

pieces of evidence properly filed in the instant case: a medical journal article filed by

both parties and a highly unusual commentary by the editor-in-chief of the medical

journal in which the article first appeared. Additionally, I reference the publically-

available docket entries in Poling and the posted rulings and decisions by the special

master. See § 12(d)(4)(b), requiring decisions of the special master to be disclosed and

the “E-Government Act,” (see n.1, supra) (requiring reasoned rulings of courts to be

publically available).

48Although the minor’s name has been disclosed publically, I will not use it in this ruling or in the

entitlement decision to follow.

49See Vernacchio v. Sec’y, HHS, No. 08-504V, 2015 WL 1951051 (Fed. Cl. Spec. Mstr. Apr. 10, 2015).

Of note, [A.K.’s father] is the counsel of record in Vernacchio. Although not raised via a

motion regarding judicial estoppel, the Poling case and the Poling medical journal case report have been

used by petitioners in several other cases alleging that a vaccine significantly aggravated or triggered a

mitochondrial disorder or dysfunction, as evidence that a vaccine can do so. See, e.g., Miller v. Sec’y,

HHS, No. 02-235V, 2015 WL 5456093 (Fed. Cl. Spec. Mstr. Aug. 18, 2015); Holt v. Sec’y, HHS, No. 05-

0136V, 2015 WL 4381588 (Fed. Cl. Spec. Mstr. June 24, 2015).

50 In citations to the Pacer docket entries in Poling, I will identify the case name, the docket number and

the ECF number for the filing at issue. With the exception of the publically available decisions and rulings

in Poling (i.e., those appearing on the Court of Federal Claims website or WestLaw), none of the matters

discussed herein with regard to Poling delve into the non-public filings. All other ECF numbers refer to

matters filed in the instant case.

19

In October of 2002, Terry and Jon Poling filed a vaccine injury claim on behalf of

their minor child. The child reportedly experienced symptoms of a developmental

regression within 48 hours of a DTaP vaccination and more symptoms of a similar

nature within five to 15 days of a measles vaccination, both of which were administered

when the child was 19 months of age. The onset of neurological symptoms was within

the periods for a DTaP Table encephalopathy (72 hours) and a measles Table

encephalopathy (5 to 15 days). The child was eventually diagnosed with both autism

and a mitochondrial disorder. Recognizing that the child experienced neurological

symptoms within the time periods required for a Table injury, respondent filed a Rule

4(c) report51 conceding that petitioners were entitled to compensation.

The journal article, J. Poling, et al., Developmental Regression and Mitochondrial

Dysfunction in a Child With Autism, J. CHILD NEUROL. 21:170-72 (2006), was filed by

both parties.52 I cite to the copy filed as Res. Ex. MM, Tab 14 [hereinafter “Poling, Res.

Ex. MM, Tab 14”]. The article contains a case study of a child who experienced a

regression after receipt of several vaccinations and who thereafter experienced a loss of

skills. This child was later diagnosed with autism and a mitochondrial disorder. The

article also contains an abbreviated analysis of laboratory studies in 159 other children

with ASD diagnoses, as compared to 94 children with neurological disorders other than

ASD, with the stated purpose of demonstrating that other children with ASD diagnoses

might also have mitochondrial disorders. Res. Ex. MM, Tab 14, at 171-72.

The commentary was filed as Res. Ex. MM, Tab 17: R. Brumback, The Appalling

Poling Saga, J. CHILD NEUROL. 23(9): 1090-91 (2008). The commentary reflected that

Dr. Jon Poling was the petitioner in a vaccine injury claim filed on behalf of his daughter.

He and his co-authors failed to disclose that conflict of interest to the medical journal

where the article was submitted and accepted for publication. The commentary

reflected that a “media frenzy” had ensued when the decision to compensate the child’s

vaccine injury case became public. The commentary’s focus was on the authors’ failure

to disclose the pending injury claim as a conflict of interest. As Dr. Brumback noted:

“Openness and transparency related to any and all potential conflicts of interest is

critical to maintaining the integrity of science in general and of journal quality in

51 As a Vaccine Rule 4 report is “information submitted to a special master or the court in a proceeding on

a petition,” it “may not be disclosed to a person who is not a party to the proceeding without the express

written consent of the person who submitted the information.” § 12(d)(4)(A). Nevertheless, as discussed

in more detail in Section II.B.3(b), infra, a copy of what purports to be the Vaccine Rule 4 report in Poling

was filed by petitioners in this case as Pet. Ex. 57. I note that the public docket in Poling, No. 02-1466,

contains an Amended Respondent’s Report, the contents of which do not appear to have been publically

disclosed. See ECF No. 27, filed on February 25, 2008.

52 Petitioners filed versions of the article published online as Pet. Exs. 40; 63, Ref. 18; and 91. Curiously,

in filing Pet. Ex. 40, petitioners identified it by the name of the last-listed author, Dr. Andrew Zimmerman,

one of the Poling child’s treating physicians, rather than by the name of the first author, Dr. Jon Poling.

Doctor Zimmerman is listed as the senior researcher (the last listed author) on the article. However, the

principal author was Jon Poling, and another author was John Shoffner, the clinician who performed the

mitochondrial disorder testing on A.K. Id. at 2. A third author was Dr. Frye, who was identified at one

point as an expert in this case. The fourth author, Dr. Andrew Zimmerman, is the person petitioners

sought to subpoena as an expert witness.

20

particular.” Id. at 1090.

Because the Poling case was settled, there was no entitlement decision

explaining the basis for the action taken in it.53 Instead, on March 6, 2008, the special

master issued an order to proceed to a damages determination. Poling, 02-1466, ECF

No. 35. In July 2010, respondent filed a proffer which Mr. and Mrs. Poling accepted.

Shortly thereafter, then-Special Master Campbell-Smith, who presided over the Poling

case through final resolution of the fees and costs in it, issued a decision awarding

compensation in the amount agreed upon by the parties. See Poling, 02-1466, ECF

Nos. 115, 117, 120, 127 (damages decisions and redacted and re-issued damages

decision). In 2011, Special Master Campbell-Smith awarded attorney fees and costs in

a published decision. Poling v. Sec'y, HHS, No. 02–1466V, 2011 WL 678559, at *1

(Fed. Cl. Spec. Mstr. Jan. 28, 2011). That decision reflects:

Respondent conceded that petitioners are entitled to compensation based

on a determination that [the minor child] suffered an injury identified on the

Vaccine Injury Table, specifically, a presumptive MMR vaccine-related

injury of an encephalopathy. [The child’s] encephalopathy eventually

manifested as a chronic encephalopathy with features of an autism

spectrum disorder and a complex partial seizure disorder as a sequela.

Id. (emphasis added). The language emphasized makes clear that the Poling case

was compensated based on the presumption of causation that attaches when the Table

injury requirements are met, not on an actual causation or causation in fact basis.

Otherwise, the reference to an injury appearing on the Vaccine Injury Table is

nonsensical, as the only injuries that appear on the Table are those for which

entitlement to compensation is presumed, such as the MMR Table injury of

encephalopathy. See 42 C.F.R. § 100.3(a)(III)(B).

2. Connections between A.K.’s Case and Poling.

In their reply to respondent’s filing regarding the motion for reconsideration of my

decision dismissing this petition for failure to prosecute, petitioners filed Pet. Ex. 57, a

document “purporting to be the complete and entire Rule 4 Report filed by the

respondent in Poling.” ECF No. 104 at 3. Petitioners requested disclosure of the actual

Rule 4 report filed in Poling and the expert reports filed in that case, singling out a report

by Dr. Andrew Zimmerman in particular. ECF No. 104 at 4, n.1. They characterized the

Rule 4 report filed in Poling as constituting:

an admission that the conditions observed in [the minor child] are

symptoms of mitochondrial disorder and that a vaccination of a person

with that condition can cause symptoms similar to those evidencing

autism. The respondent is estopped from taking any position in the instant

53Although respondent apparently conceded entitlement to compensation in her Rule 4 report in the

Poling case, thereafter petitioner filed two expert reports in that case, including one by Dr. Andrew

Zimmerman. See ECF Nos. 22 and 24, Case No. 02-1466.

21

case that is inconsistent with the [sic] Poling Rule 4 Report.

ECF No. 104 at 6.

Petitioners reiterated the arguments made in this reply brief when they filed the

motion on April 8, 2013, seeking application of judicial estoppel or to compel respondent

to admit the validity of their medical theory. See ECF No. 227. They reiterated their

argument concerning their “right” to obtain a copy of Dr. Zimmerman’s report in the

Poling case in their March 31, 2013 “Motion for Leave to Serve a Deposition Subpoena

or Other Appropriate Relief, Including Disclosure of Relevant Evidence.”54 ECF No. 216

at 1.

In her expert report and at the hearing, petitioners’ mitochondrial disease expert,

Dr. Fran Kendall, placed considerable reliance on the Poling article, Res. Ex. MM, Tab

14. It was one of the two medical journal articles she cited in support of her theory that

vaccines could cause or trigger a mitochondrial regression resulting in an ASD

diagnosis. Pet. Ex. 65 at 7-8. She testified similarly. See Tr. at 254, 285-86. However,

in testimony, she acknowledged that the facts in the Poling case report bore little

resemblance to the facts in the case at bar. Tr. 367-71.

3. Issues Raised by Petitioners’ Reliance on Poling.

Petitioners’ reliance on the Poling case raises three issues in the instant case.

The first is their use of documents barred by § 12(d)(4)(A) of the Vaccine Act. The

second is their contention that Dr. Zimmerman can be compelled to offer expert

testimony. The third is their judicial estoppel argument.

a. Filings in Violation of the Vaccine Act.

Section 12(d)(4)55 of the Vaccine Act governs the disclosure of information

54This filing contains a troubling misstatement, in that it claims petitioners learned only on March 30,

2013 that petitioners in Poling filed a report by Dr. Andrew Zimmerman. ECF No. 216 at 1. Their filing of

November 6, 2010 (ECF No. 104) reflected that they were aware of such an expert report filing long

before March 2013. Id. at 4, n.1.

55 Section 12(d)(4) provides:

(A) Except as provided in subparagraph (B), information submitted to a special master or

the court in a proceeding on a petition may not be disclosed to a person who is not a

party to the proceeding without the express written consent of the person who submitted

the information.

(B) A decision of a special master or the court in a proceeding shall be disclosed, except

that if the decision is to include information--

(i) which is trade secret or commercial or financial information which is privileged

and confidential, or

22

submitted during a vaccine proceeding. The language of § 12(d)(4) is incorporated into

Vaccine Rule 18. Congress added this section in amendments it made to the Vaccine

Act in 1989. P.L. No. 101-239, 103 Stat. 2106.

The legislative history for the language prohibiting disclosure of information

submitted during vaccine proceedings without written consent (which now appears at §

12(d)(4)(A)) was originally located at the end of the paragraph describing the special

masters’ discovery powers (§ 12(c)(2) (Supp. V 1988)). In the 1989 amendments, this

non-disclosure provision, which abrogated the common law rule that court filings are

open to public scrutiny, was moved to § 12(d)(4)(A) and the new directive requiring the

disclosure of vaccine decisions was added in § 12(d)(4)(B). See H.R. Conf. Rep. 101-

386, at 512-13 (1989), reprinted in 1989 U.S.C.C.A.N. 3018, 3115-16; see also

Castagna v. Sec’y, HHS, No. 99-411V, 2011 WL 4348135, at *6-7 (Fed. Cl. Spec. Mstr.

Aug. 25, 2011) (for a comprehensive discussion of the legislative history of the Vaccine

Act and the 1989 amendments).

Under § 12(d)(4)(A), information submitted to a special master in a case may not

be disclosed without the express written consent of the party who submitted the

information. Thus, Congress protected any information submitted by a party from public

view, effectively sealing pre-decisional Vaccine Act proceedings. This is a departure

from the common law right of access to judicial records. See, e.g., Nixon v. Warner

Communications, Inc., 435 U.S. 589, 597 (1978) (remarking that “the existence of a

common-law right of access to judicial records” is widely acknowledged, though as “[a]n

infrequent subject of litigation, its contours have not been delineated with any precision.”

The Court also stated that “[i]t is clear that the courts of this country recognize a general

right to inspect and copy public records and documents, including judicial records and

documents” (internal citations omitted).).

In spite of the explicit language in the Vaccine Act and Vaccine Rule 18,

petitioners filed several documents in this case that they claim were filed in Poling: (1)

the Rule 4 report (Pet. Ex. 57);56 (2) a largely illegible two page document taken from a

(ii) which are medical files and similar files the disclosure of which would

constitute a clearly unwarranted invasion of privacy,

and if the person who submitted such information objects to the inclusion of such information in the

decision, the decision shall be disclosed without such information.

56It does not appear that respondent has formally challenged the admissibility of the Rule 4 report from the

Poling case filed as Pet. Ex. 57 in the instant case, although she may have addressed the issue

obliquely in some filings. While this lack of formal challenge may not constitute the “express written

consent” of the party who submitted this information, the lack of any objection, coupled with respondent’s

reliance on matters contained in Pet. Ex. 57 in at least one document filed in this case (see ECF 308 at 8,

n.8), leads me to treat respondent’s lack of objection as consent. I will also treat respondent’s citation to

Pet. Ex. 57 as an implicit concession that the document is what it purports to be—a somewhat

expurgated version of the Rule 4 report filed in the Poling case. Notwithstanding the public and highly

improper disclosure of this Rule 4 report, Vaccine Rule 4 reports are not intended for public release, and

as such are not drafted with the intent to explain in detail all of the considerations that may lead

respondent to concede a case or to compensate a case based on a litigative risk assessment. The only

way to enforce the clear statutory intent that what a party files remains exempt from public disclosure

23

website that appears to be a letter written by Dr. Zimmerman (Pet. Ex. 283); (3) a letter

from Dr. Zimmerman to petitioners’ counsel in Poling that appears to address the issue

of sequela of the original Table encephalopathy, also obtained from a website (Pet. Exs.

284 and 285); (4) a mostly illegible copy of a PowerPoint slide which appears to be the

last page of the Zimmerman letter, titled “Dr. Zimmerman’s Second Medical Opinion

Letter”(Pet. Ex. 286); and (5) another copy of the letter from Dr. Zimmerman to

petitioners’ counsel in the Poling case, dated November 30, 2007 (Pet. Ex. 277).

As articulated in their June 26, 2014 motion to reopen the record and file Dr.

Zimmerman’s report out of time (ECF No. 306), petitioners reiterated their claim that

they learned of Dr. Zimmerman’s report only on March 30, 2013. This claim is

erroneous. See, supra, n.54. In their motion, they acknowledged that the matters filed

in the Poling case remained sealed, speculating that they remained so in order “to

secure a financial settlement for the severely injured minor petitioner.”57 ECF 306 at 8.

Noticeably lacking in the motion for leave to file Pet. Ex. 277 out of time (ECF

No. 306) and in any of the other filings in this case is any suggestion that the petitioners

in this case secured the ”express written consent” of the persons who submitted Dr.

Zimmerman’s letter or respondent’s Rule 4 report in Poling.

Another round of briefing ensued on this issue. See ECF Nos. 308, 309.

Respondent noted that the timing of the filing of Dr. Zimmerman’s expert report in Poling

indicated that it was not the basis for respondent’s concession, as the report was filed

after respondent’s first substantive Rule 4 report conceding the case.58 See ECF No.

308 at 8, n.8. Petitioners argued that there was no impropriety in seeking to file Pet. Ex.

277 because it had “been published repeatedly on the internet, and ha[d] been

presented more than once in public events.” ECF No. 309 at 6-7. They argued that

“fundamental fairness and due process of law” compel the admission of Dr.

Zimmerman’s report.

(except to the extent these matters are relied on in a special master’s decision) is to preclude the filing of

documents from one case in another case, absent that “express written consent.” However, as

respondent has used that Rule 4 report as a sword in this case, I will not preclude its use by petitioners. I

therefore find petitioners’ request for disclosure of the Rule 4 report in Poling (see ECF No. 104 at 4, n.1)

moot as the evidence sought is already before me.

57Once again, a review of the publically available docket in Poling reveals that on July 20, 2009,

petitioners filed a motion to withdraw a previously filed motion (ECF No. 86). After additional filings by

both sides (see ECF Nos. 88 and 90), the presiding special master granted a “Motion for Appropriate

Relief,” filed by respondent on June 26 2008 (referencing ECF No. 61) and a granted “Motion to Withdraw

Motion for Complete Transparency” filed by petitioners (referencing ECF No. 86). See Order issued Aug.

20, 2009 (ECF No. 92). The decision awarding damages was not issued until nearly a year later (July 21,

2010), which is hardly suggestive of a quid pro quo.

58 Respondent filed an initial Rule 4 report in Poling in January 2003. It was likely a pro forma report

reflecting that petitioners had not filed medical records sufficient for respondent to assess the case and

objecting to the use of a short form petition, as both objections were commonly made in the OAP cases

filed pursuant to Vaccine General Order #1. See Poling ECF No. 5. This assumption is borne out by the

Order Deferring Ruling on Petitioners' Motion for Complete Transparency of Proceedings. Poling, 2008

WL 1883059, at *11-12.

24

b. Motions Regarding Dr. Zimmerman.

Leaving the issue of violations of § 12(d)(4)(A) aside temporarily, there are other

issues surrounding the use of Dr. Zimmerman’s report that are bound up with

petitioners’ requests to depose him or compel his appearance at the hearing in their

son’s case.

Petitioners first requested disclosure of Dr. Zimmerman’s expert report in Poling

in their reply to respondent’s objection to petitioners’ motion for relief from my decision

dismissing their claim.59 See ECF No. 104 at 4, n.1. They apparently believed that Dr.

Zimmerman had filed a report that had affected respondent’s decision to concede the

Poling case, and argued that because Poling was “designated” as a test case, the

waiver of the privacy provisions filed by petitioners in each of the actual test cases

somehow applied to the Poling case as well.

Based on the OAP docket (http://www.cofc.uscourts.gov/docket-omnibus-autism-

proceeding), as well as the docket in Poling, No. 02-1466, petitioners’ assertions are

factually incorrect. The Poling case was never formally designated as a test case,

(Poling, 2008 WL 1883059, at *1-2), and the petitioners in that case consequently never

filed that express written consent.60

Given the procedural posture of this case at the time, I did not rule on petitioners’

request, expecting that petitioners would retain experts and file their reports pursuant to

my orders, likely obviating the need to decide whether production of the expert report

was within my authority and necessary to a fair and just resolution of the issues.

Apparently unsatisfied by the experts they had obtained, on March 31, 2013,

petitioners moved for leave to serve a subpoena on Dr. Zimmerman. Petitioners’

Motion for Leave to Serve a Deposition Subpoena or Other Appropriate Relief, Including

Disclosure of Relevant Evidence [hereinafter “Pet. Mot. for Subpoena”], filed Mar. 31,

59They also requested disclosure of the other expert reports filed in Poling, asserting that, as these

expert reports were filed while the Poling case was under consideration as a test case, they should be as

publically available as the reports in other test cases. Again, with reference to the public docket in Poling,

No. 02-1466, there is no indication that any expert reports were filed in Poling prior to the government’s

concession in the November 2007 Rule 4 report. Pet. Ex. 57, the Rule 4 Report in Poling, does not

reference any expert reports, referring only to the treatment and diagnostic records.

60 The Poling case does appear on the “List of Potential Test Cases for May 2008 Hearings,” the hearings

in the Theory 2 test case as one of three cases being considered for test case designation. See Autism

Master File, OAP docket, filing of Sep. 17, 2007, at 3. See http://www.cofc.uscourts.gov/docket-omnibus-

autism-proceeding. The filing contained the disclaimer: “By filing these records and designating these

claims as ‘potential test cases,” neither claimant nor the PSC represent that any one petition will actually

be designated for hearing in the May 2008 general causation proceedings.” Id. at 1; see

http://www.cofc.uscourts.gov/docket-omnibus-autism-proceeding. Once again, petitioners in the instant

case either misconstrued or misstated what had occurred. I note that A.K.’s own case, which did not

appear on the list of “potential test cases,” was designated as a test case on January 8, 2008, via the

filing of an expert report in the [R.K, on behalf of A.K.] case in the OAP docket on that date. “PSC's Expert

Report in [R.K, on behalf of A.K.] Test Case” at 1; see http://www.cofc.uscourts.gov/docket-omnibus-

autism-proceeding. The report was removed from the OAP docket when petitioners in [R.K, on behalf of

A.K.] withdrew as a test case.

25

2013 (ECF No. 216). On close examination, the subpoena request was a thinly veiled

attempt to compel Dr. Zimmerman to give expert testimony in this case, rather than

testify as a percipient witness, treating physician, or retained expert. Later, petitioners

conceded that they had contacted Dr. Zimmerman “and were informed that he would

not testify as an expert except in cases in which he was the treating physician.” ECF

309 at 7-8 (Petitioners’ Reply Brief in support of their motions to reopen the record and

judicial estoppel). Petitioners’ many filings on the Zimmerman subpoena issue are rife

with misstatements or misunderstandings of the matters asserted. The facts (and their

assertions) overlap to some extent with those in the estoppel motions. I thus address

the background matters pertinent to both motions here.

c. Additional Background Information and Facts.

Petitioners claim that they only learned of Dr. Zimmerman’s report in Poling on

March 30, 2013. ECF No. 216 at 1. This assertion is rebutted by their own earlier filing

of November 6, 2010 (ECF No. 104), which reflected that they were aware of such an

expert report filing long before March 2013. Id. at 4, n.1. See n.54 supra.

Petitioners’ claim that the Poling case involved a concession of causation based

on Dr. Zimmerman’s report in Poling (ECF No. 216 at 3-4) is raised in several filings.

See, e.g., ECF No. 227 at 5, n.5 (referencing their request for Dr. Zimmerman’s report

in ECF No. 216); ECF No. 227 at 15 (asserting that the Zimmerman’s report in Poling

was a decisive factor in the decision to settle).61 The timeline and records in Poling

reflect otherwise.

On November 9, 2007, respondent conceded petitioners’ entitlement to

compensation in Poling in her Rule 4 report. Poling ECF No. 17; Pet. Ex. 57. Five days

later, the presiding special master ordered a status conference “to discuss further

proceedings to address damages.” Poling ECF No. 18. Doctor Zimmerman’s report

was filed on December 13, 2007, more than a month after respondent’s Rule 4 report

was filed. Poling ECF No. 24. Thus, the temporal relationship alone belies petitioners’

assertions that Dr. Zimmerman’s expert report resulted in the concession.62

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61This description may not be entirely inaccurate. Doctor Zimmerman’s report may have played a role in

the amount of compensation petitioners in Poling ultimately received, because the first substantive Rule 4

report in Poling denied that the Poling child’s seizure disorder was related to the encephalopathy for

which entitlement was conceded. The special master’s fees and costs decision reflected that the Poling

petitioners were compensated for the seizure disorder as well as the other injuries that were conceded in

the Rule 4 report. Poling, 2011 WL 678559, at *1.

62As one of the Poling child’s treating physicians, it is possible and even likely, that opinions on

connection or causation by Dr. Zimmerman were expressed in the child’s medical records. These do not

constitute “expert reports,” and in any event such documents are not publically available, absent express

written consent of the petitioners in the Poling case.

26

[*********************************************************

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[****************************************************

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Given that respondent’s amended Rule 4 report, filed on February 21, 2008

(Poling, No. 02-1466, ECF No. 27), has never been publically disclosed, the best

evidence of why respondent conceded entitlement to compensation would be found in

the special master’s decisions in that case. However, neither the special master’s order

to proceed to a damages determination (Poling, No. 02-1466, ECF No. 35) (which is

not, strictly speaking a “decision” based on the use of that term in the Vaccine Act), nor

her decisions awarding damages (see Poling, No. 02-1466, ECF Nos. 115, 117, 120,

and 127) are publically available under the name “Poling.”63

As the special master assigned to Poling explained in her April 10, 2008 Order,

Dr. Zimmerman’s report— [ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ] —was not filed

until after respondent’s initial Rule 4(c) report. Poling v. Sec’y, HHS, No. 02-1466V,

2008 WL 1883059, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2008) (Order Deferring Ruling

on Petitioners’ Motion for Complete Transparency of Proceedings). Because the facts

demonstrate that Dr. Zimmerman’s report in Poling was filed after the case was

conceded in the Rule 4 report, it could not possibly have been a factor in respondent’s

decision to concede entitlement to compensation on the basis of a Table injury.

The unredacted attorney fees and costs decision filed on January 28, 2011, (see

Poling, 2011 WL 678559) answers the question of why the Poling case was conceded.

There, the special master clearly and unequivocally noted that the concession was

based on the presence of a Table encephalopathy. When a prima facie case for a

Table encephalopathy exists, causation is presumed. See 42 C.F.R. § 100.3; de

Bazan, v. Sec'y, HHS, 539 F.3d 1347, 1354 (Fed. Cir. 2008) (citing Knudsen v. Sec'y,

HHS, 35 F.3d 543, 548 (Fed.Cir.1994). Such a presumption may not be rebutted by the

presence of an “idiopathic, unexplained, unknown, hypothetical, or undocumentable

cause, factor, injury illness, or condition.” §13(a)(2). The cause of most cases of ASD

63A redacted damages decision, CHILD DOE/77 v. Sec’y, HHS, 2010 WL 3395654 (Fed. Cl. Spec. Mstr.

Aug. 27, 2010), was issued the same date that a redacted damages decision entry appears in the docket

of the Poling case (Poling ECF No. 127). A perusal of the redacted decision suggests that these two

cases are one and the same. However, I do not rely on the redacted CHILD DOE/77 decision to

determine why respondent conceded the Poling case, if, indeed, they are the same case.

27

is unknown, although genetic factors and prenatal influences are strongly suspected.

Dwyer, 2010 WL 892250, at *29-36; Snyder, 2009 WL 332044, at *46-53. Thus, a “she

has ASD” defense would not suffice to demonstrate alternate causation.

I find that the Zimmerman expert report was not what prompted the respondent

to concede the Poling case. I find, consistent with the presiding special master’s

published decision, that the Poling case was conceded based on the presence of a

Table encephalopathy.

d. Issues Related to Concession, Conspiracy, and Concealment.

In numerous filings, petitioners have obstinately insisted that respondent, her

agents, or other governmental officials have conceded the causation theory they have

advanced.64 They claimed that respondent deliberately conceded the Poling case to

avoid having a special master rule on the issues presented, and thereafter concealed

what had happened in Poling. These issues all feed into the judicial estoppel

arguments.

Petitioners first asserted that respondent had, in effect, conceded their theory of

causation in October of 2010, when they filed their Motion for Reconsideration and

Relief from Order and Decision Dismissing Petition (ECF No. 100). In support of their

argument that I restore their petition, petitioners provided a quotation65 from Dr. Julie

Gerberding, former Director of the Center for Disease Control, and stated that “[t]hus,

mitochondrial dysfunction can generate autism-like symptoms.” Motion for

Reconsideration (ECF No. 100) at 14.

In their subsequent Reply, filed November 6, 2010, petitioners took their

admission argument a step further. They argued that “[t]he Rule 4 Report filed in Poling

is a pleading in a prior proceeding and constitutes an admission that…a vaccination of a

person with [a mitochondrial disorder] can cause symptoms similar to those evidencing

autism.” Petitioners’ Reply to respondent’s Response to Motion to Reconsider, filed

November 6, 2010, at 6 (ECF No. 104).

For the past five years, petitioners have repeatedly insisted that the government

conceded the Poling petitioners’ theory of causation and is thus unable to contest their

64 Petitioners are not always consistent about the causation theory they claim was “conceded.” See, e.g.,

Reply to Response to Motion for Reconsideration, filed Nov. 6, 2010, at 6 (ECF No. 104) (stating that the

Poling Rule 4 report was an admission that vaccination of a person with a mitochondrial disorder can lead

to symptoms of autism); Motion to Amend Schedule and Award Interim Cost of Expert Witness, filed Nov.

30, 2010, at 3 (ECF No. 109) (stating that the government had conceded a “mitochondrial

encephalopathy”).

65Doctor Gerberding’s comments about the Poling case were prefaced by her statement: “I don’t have all

the facts because I still haven’t been able to review the case files myself.” Pet. Ex. 37 at 3. I note that

she is a doctor, not a lawyer and, while she may have general medical knowledge about decompensation

and regression in mitochondrial disorders, there is no evidence of her medical specialty. Saying that

respondent is bound by an uninformed comment by a subordinate official is absurd. Holt, 2015 WL

4381588, at *29 n.80.

28

entitlement to compensation. Their arguments generally fell into six categories. First,

they claimed that respondent has conceded the theory of causation in a party

admission. See, e.g., Motion for Reconsideration (ECF No. 100), Reply (ECF 104),

Petitioners’ Motions in Limine, filed Apr. 8, 2013 (ECF No. 227), Prehearing

Submissions, filed Apr. 8, 2013 (ECF No. 228), Motion for Leave to File Exhibits, filed

Jun. 17, 2014 (ECF No. 303). Second, they insinuated that respondent purposefully

avoided an adverse ruling in Poling by removing it from the OAP and attempting to

prevent the disclosure of any facts to the public, implying that respondent’s actions were

in some way underhanded. See, e.g., Motion to Issue Subpoena, filed Mar. 31, 2013

(ECF No. 216), Motions in Limine (ECF No. 227), Reply to Motions in Limine, filed May

20, 2013 (ECF No. 259), Supplemental Motion for Leave to File Exhibits, filed Jun. 26,

2014 (ECF No. 306).66 This argument, which is completely unfounded, entirely

mistakes the progression of events surrounding the Poling case.67 Their third argument

was that courts have already accepted their causation theory. See, e.g., Motions in

Limine (ECF No. 227), Post-Hearing Brief, filed May 5, 2014 (ECF No. 297), Motion for

Leave to File Exhibits (ECF No. 303), Supplemental Motion for Leave to File Exhibits

(ECF No. 306). Fourth, they argued that Dr. Zimmerman’s expert report from the Poling

case directly led to that case’s concession.68 See, e.g., Motion to Amend Schedule,

filed Nov. 30, 2010 (ECF No. 109), Motions in Limine (ECF No. 227), Supplemental

Motion for Leave to File Exhibits (ECF No. 306). Fifth, they insisted that it is

fundamentally unfair for the government to be allowed to take an inconsistent position in

this case, given their concession of Poling. See, e.g., Motions in Limine (ECF No. 227),

66In this filing, petitioners asserted that the government may have suppressed information regarding

vaccine safety. ECF 309 at 9.

67 Petitioners in Poling filed a “Motion for Complete Transparency of Proceedings” on March 4, 2008. On

April 10, 2008, then-Special Master Campbell Smith issued a published Order Deferring Ruling on

Petitioners’ Motion for Complete Transparency of Proceedings, No. 02-1466V, 2008 WL 1883059 (Fed. Cl.

Spec. Mstr. Apr. 10, 2008). Special Master Campbell-Smith provided an exhaustive history of the

matter and ultimately concluded that any public disclosure of case materials, including the Rule 4

Reports, would, under § 12(d)(4)(A) of the Vaccine Act, require the consent of the parties. When she

issued her Order, the parties had “been unable to execute a signed consent form.” Id. at *11. She

encouraged the parties to execute such a form given their “expressed willingness” to do so and provided

the parties with 60 days within which to come to an agreement. Id. Apparently, the parties never

managed to resolve the issue, as the Poling docket indicates that more than a year later, Special Master

Campbell-Smith ordered petitioners to file a motion withdrawing their motion for complete transparency by

July 22, 2009 (ECF No. 85). On July 20, 2009, petitioners filed a “Motion to Withdraw Previously Filed

Motion” (ECF No. 86), which presumably was the motion for complete transparency. Special Master

Campbell-Smith’s Order and the publically available Poling docket entries make clear that both

respondent and petitioners were interested in complete public disclosure of all of the facts and records

related to the Poling case. Had the parties managed to execute a signed consent agreement in

accordance with § 12(d)(4)(A) of the Vaccine Act, petitioners’ motion likely would have been granted.

Contrary to petitioners’ claims in the instant case, respondent did not purposefully prevent the public

disclosure of the Poling Rule 4 Reports. (It is worth noting that Rule 4 Reports are customarily never

publically disclosed, so respondent’s willingness to disclose the Poling Rule 4 Reports, contingent upon

petitioners’ permission, was rather extraordinary. If anything, this indicates that respondent was very

interested in the public dissemination of the Poling case materials.)

68Respondent contested petitioners’ statement that Poling was settled in part because of the expert

reports. In her Response, respondent stated that compensation in that case was not based on expert

reports. Respondent’s Response, filed Dec. 14, 2010 (ECF No. 113), at 2, n.1.

29

Reply to Motions in Limine (ECF No. 259), Motion for Leave to File Exhibits (ECF No.

303), Supplemental Motion for Leave to File Exhibits (ECF No. 306). And finally, they

argued that the government has a duty to the public to provide evidence in support of

petitioners’ theories. See, e.g., Motion to Issue Subpoena, filed Mar. 31, 2013 (ECF No.

216), Supplemental Motion for Leave to File Exhibits (ECF No. 306), Reply to Response

to Supplemental Motion for Leave to File Exhibits, filed Jul. 14, 2014 (ECF No. 309).

Petitioners in the instant case asserted that Dr. Zimmerman’s testimony would

support the medical theory that they advanced and sought to compel his expert opinion.

See generally Pet. Mot. for Subpoena (ECF No. 216). Petitioners did not cite any legal

authority that would empower me to compel an expert witness to provide an opinion, nor

did they assert that Dr. Zimmerman had ever met, let alone treated, A.K.

Respondent filed her response on April 8, 2013. She correctly noted that the

Vaccine Act does not provide petitioners a right to discovery (see Response at 1-2 (ECF

No. 224); see also 42 U.S.C. § 300aa-12(d)(3)(B)), and, further, that petitioners did not

demonstrate how subpoenaing Dr. Zimmerman would lead to any information relevant

to their case. See Response at 3-4.

4. Legal Standards and Analysis.

a. Standard for Compelling Discovery and Expert Witness Testimony.

Under the rules for civil procedure governing litigation in the Court of Federal

Claims and other federal courts, a judge may authorize a subpoena to an expert

witness. However, this authority is rarely invoked or granted. See Resource

Investments, Inc. v. U.S. [Resource II], 93 Fed. Cl 373, 378 (2010). “[A]lthough it is not

the usual practice, a court does have the power to subpoena an expert witness and,

though it cannot require him to conduct any examinations or experiments to prepare

himself for trial, it can require him to state whatever opinions he may have previously

formed.” Carter-Wallace, Inc. v. Otte, 474 F.2d 529, 536 (2d. Cir. 1972). See also

Kaufman v. Edelstein, 539 F.2d 811 (2d. Cir. 1976) (an antitrust case determining that

an expert may be called against his will if “[a] substantial part of the testimony which the

Government…seeks…is testimony no one else can give.”).

These rules do not govern discovery in Vaccine Act proceedings, but the cases

interpreting them may be helpful in understanding why such subpoenas are limited to

unusual factual situations. The Vaccine Act provides that rules for proceedings under

the Act shall “provide for limitations on discovery and allow the special masters to

replace the usual rules of discovery in civil actions in the United States Court of Federal

Claims.” §12(d)(2)(E). They further provide the presiding special master the authority

to “require such evidence as may be reasonable and necessary” and to “require the

testimony of any person and the production of any documents as may be reasonable

and necessary.” § 12(d)(3)(B)(i) and (iii).

Courts have, on occasion, subpoenaed an expert witness who already has

30

critical information about a pending case. But if an expert is not willing to opine and is

not already familiar with the case, courts have held that he should not be subpoenaed.

See, e.g., Buchanan v. Am. Motors Corp., 697 F.2d 151 (6th Cir. 1983) (holding that the

district court did not err in quashing a subpoena for an expert witness who was a

stranger to the litigation). Courts are generally discouraged from subpoenaing expert

witnesses. See, e.g., Fed. R. Evid. 706 (stating that although a court may appoint an

expert witness, it “may only appoint someone who consents to act.”). As Judge Block

has noted, “expert testimony is ordinarily a matter of private contract and may not be

compelled.” Resource II, 93 Fed. Cl. at 378. An expert witness “is ordinarily not the

proper subject of a subpoena.” Id. at 383.

Parties to a case authorized by the Vaccine Act are not entitled to formal

discovery; informal exchanges of relevant information are preferred. Rule 7(a). Should

a party determine that informal discovery is inadequate, “the party may move the

special master…to employ any of the discovery procedures set forth in RCFC 26-37.”

Rule 7(b)(1). Any such motion must include “the discovery sought and state with

particularity the reasons therefor, including an explanation as to why informal discovery

techniques have not been sufficient.” Rule 7(b)(2). Upon a party’s request, a “special

master may approve the issuance of a subpoena pursuant to RCFC 45.” Rule 7(c)

(emphasis added).

Court of Federal Claims Rule 45 explains the procedures required for the

issuance of a subpoena, but notes that the court may quash a subpoena if it requires

“disclosing an unretained expert’s opinion or information that does not describe specific

occurrences in dispute and results from the expert’s study that was not requested by a

party.” RCFC 45(d)(3)(B). Notwithstanding a judicial officer’s discretion to quash or

modify a subpoena in such circumstances, the court may elect to order appearance or

production if two criteria are met: (1) the serving party “shows a substantial need for the

testimony or material that cannot be otherwise met without undue hardship;” and (2) the

serving party “ensures that the subpoenaed person will be reasonably compensated.”

RCFC 45(d)(3)(C).

b. Application to This Case.

Although a court may, when circumstances warrant, compel an expert to provide

testimony, this is a significant departure from the general rule that an expert witness

should not be compelled to testify. See Resource II, 93 Fed. Cl. at 378. Courts are

reluctant to subpoena expert witnesses unless they already have critical information

related to the case at bar. See Buchanan, 697 F.2d 151. Absent extraordinary

circumstances, it is inappropriate to approve a subpoena for an expert witness who is

not willing to opine.

Under RCFC 45(d)(3)(B), I may quash a subpoena that would require the

disclosure of “an unretained expert’s opinion…that does not describe specific

occurrences in dispute and results from the expert’s study that was not requested by a

party.” Doctor Zimmerman’s report in the Poling case does not describe “specific

31

occurrences in dispute” in the instant case. [ * * * * * * * * * * * * * * * * * * * * * * * * *

******************************************************

******************************************************

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ] Moreover, as Dr. Zimmerman

has never treated A.K., he has no familiarity whatsoever with the case at bar. And,

as petitioners’ own expert conceded at trial (Tr. 368-71), the facts of A.K.’s case bear

no resemblance to those in the Poling case. Thus, RCFC 45(d)(3)(B)

overwhelmingly favors denying petitioners’ request for a subpoena for Dr.

Zimmerman.

5. Denying Subpoena.

Although a subpoena for expert testimony may be appropriate in some

extraordinary circumstances, they do not exist here, where Dr. Zimmerman has never

treated A.K. and has declined to offer an expert opinion. RCFC 45(d)(3)(C) empowers

me to, in my discretion, order the testimony of a witness if petitioners have a

“substantial need for the testimony” that they could not otherwise obtain “without due

hardship” and petitioners ensure that the witness will be “reasonably compensated.”

Petitioners have made no such showing.

Furthermore, I do not find such action to be reasonable and necessary to a fair

and just resolution in this case. Petitioners produced a qualified expert (Dr. Fran

Kendall) who opined that vaccines can trigger or aggravate an underlying mitochondrial

disorder. Even if Dr. Zimmerman’s testimony would buttress that of Dr. Kendall (and,

his willingness to testify only in cases in which he has been a treating physician

suggests that his opinions are narrower and more nuanced than petitioners claim), it is

not reasonable or necessary in this case.

In my discretion, I find that petitioners have not demonstrated a need for Dr.

Zimmerman’s testimony about an unrelated case alleging a somewhat similar injury

caused by different vaccinations. Their motion for a subpoena is DENIED.

6. Judicial Estoppel.

a. Background of the Motions.

Petitioners requested that I issue an order either compelling respondent “to admit

that a vaccine can cause significant aggravation of a pre-existing mitochondrial disorder

which may can manifest[ ] as an encephalopathy with features of autistic spectrum

disorder,” or to bar, “on the grounds of estoppel, respondent from denying that a

vaccine can cause significant aggravation of a pre-existing mitochondrial disorder.”

Motions in Limine at 20 (ECF No. 227).

Respondent filed her Response [hereinafter “Response to Motions in Limine”] to

petitioners’ motion for judicial estoppel on May 13, 2013. Respondent argued that

petitioners’ request was barred as a matter of law. Response to Motions in Limine at 1-

2 (ECF No. 258). Additionally, respondent asserted that she never conceded that a

32

vaccine was capable of significantly aggravating a pre-existing mitochondrial disorder

and, moreover, that the instant case differed from Poling in “many critical ways,”

including the vaccine in question and the presence or absence of a Table injury.

Response to Motions in Limine at 2-3 (ECF No. 258).

On May 20, 2013, petitioners filed a Reply to Respondent’s Response to their

Motions in Limine [hereinafter “Pet. Reply”] in which they argued that respondent had

“profoundly mischaracterize[d]” their motion for judicial estoppel (Pet. Reply at 1 (ECF

No. 259)), focusing on collateral estoppel rather than judicial estoppel (id. at 5).

Petitioners described the Rule 4(c) report respondent filed in Poling as “an admission by

respondent in a pleading that vaccinations can aggravate an underlying mitochondrial

disorder.” Id. at 3. Since they contend that their case was substituted for Poling as a

test case once Poling was withdrawn from the OAP, petitioners argue that the Rule 4(c)

report filed by respondent in Poling is binding on respondent in their case. Id. at 4.

There is no evidence that this assertion is correct. Petitioners also argue that the

doctrine of collateral estoppel is inapplicable here because petitioners were parties to

the OAP at the time the Poling report was filed. Id. at 5. Nevertheless, petitioners

argue, respondent should be unable to “relitigate an issue resolved within the Omnibus

Cases as it applies to a former omnibus participant,” id. at 7, and essentially seek to

invoke collateral estoppel against respondent as an alternative theory.

Petitioners renewed their motion in their post hearing brief69 and again on June

17, 2014. See Motion to Renew Petitioners’ Motion to Compel Respondent’s Admission

of the Medical Theory Upon Which Petitioners Rely, filed Jun. 17, 2014 (ECF No. 303).

Respondent reiterated her objections to the invocation of estoppel. See Respondent’s

Response to Petitioners’ Motions, filed Jul. 7, 2014 (ECF No. 308). The matter has

remained pending.

b. Legal Standards and Analysis.

(1) Estoppel.

Estoppel is a common law doctrine that sometimes functions to prevent a party in

one lawsuit from taking a contrary position or relitigating issues in a subsequent lawsuit.

There are two discrete forms of estoppel—judicial and collateral. Judicial estoppel is

used to prevent a party from making an argument in a legal proceeding that is

inconsistent with an argument that same party took in a previous proceeding. New

Hampshire v. Maine, 532 U.S. 742, 749 (2001); see also Pegram v. Herdrich, 530 U.S.

211, 277, n.8 (2000). Under the doctrine of judicial estoppel, “where a party assumes a

certain position in a legal proceeding, and succeeds in maintaining that position, he may

not thereafter, simply because his interests have changed, assume a contrary position,

especially if it be to the prejudice of the party who has acquiesced in the position

formerly taken by him.” Davis v. Wakelee, 156 U.S. 680, 689 (1895). In essence, a

party to litigation may not use an inconsistent position to seek an advantage when doing

so would require the party to rely upon an incompatible theory. Judicial estoppel

69 See Pet. Post-Hearing Memo, filed May 5, 2014, at 115-117 (ECF 297).

33

protects the integrity of the judicial process by “prohibiting parties from deliberately

changing positions according to the exigencies of the moment.” New Hampshire, 532

U.S. at 750 (internal citation omitted). “Because the rule is intended to prevent improper

use of judicial machinery, judicial estoppel is an equitable doctrine invoked by a court at

its discretion.” Id.

As a threshold matter, judicial estoppel requires a final decision on the merits. It

therefore does not apply if a party settled the claim in which it allegedly held a contrary

or inconsistent position. Moreland Corp. v. United States, 76 Fed. Cl. 268, 294 (2007);

see also Vernacchio, 2015 WL 1396357, at *5. Assuming that this basic requirement is

met, courts then consider whether the invocation of judicial estoppel is appropriate.

In order to use the doctrine of judicial estoppel against an opposing party, a

litigant must first satisfy three requirements. First, courts determine whether one party’s

position is “clearly inconsistent” with its previous position. Second, courts consider

whether a party’s later inconsistent position could pose a threat to judicial integrity.

(Courts avoid accepting inconsistent positions in a later proceeding if doing so would

“create the perception that either the first or the second court was misled.” Moreland,

76 Fed. Cl. at 294 (quoting Cuyahoga Metropolitan Housing Authority v. U.S., 65 Fed.

Cl. 534, 556 (2005)). Third, courts consider “whether the party seeking to assert an

inconsistent position would derive an unfair advantage or impose an unfair detriment on

the opposing party if not estopped.” Id.

Collateral estoppel, also known as issue preclusion, prevents a party from

relitigating an issue that has already been decided. The doctrine provides that “a

judgment on the merits in the first suit precludes relitigation in a second suit of issues

actually litigated and determined in the first suit.” Innovad Inc. v. Microsoft Corp., 260

F.3d 1326, 1334 (Fed. Cir. 2001). Essentially, if a court has “decided an issue of fact or

law necessary to its judgment, that decision may preclude relitigation of the issue in a

suit on a different cause of action involving a party to the first case.” San Remo Hotel,

L.P. v. City and County of San Francisco, Cal., 545 U.S. 323, 336 n.16 (2005) (quoting

Allen v. McCurry, 499 U.S. 90, 95 (1980)). As with judicial estoppel, in order to invoke

collateral estoppel, a court must have issued a final decision on the merits of a case.

Although there are several ways a party can use collateral estoppel, the one

most relevant to petitioners’ argument is offensive non-mutual collateral estoppel,

whereby a new plaintiff in a later lawsuit attempts to assert a final judgment on a

particular issue against the defendant from an earlier lawsuit. In such cases, courts

employ the Parklane Hosiery test to determine whether the invocation of collateral

estoppel is appropriate. Courts ask if the party trying to assert collateral estoppel could

have intervened in the earlier suit; whether the defendant had incentive to litigate the

first action; whether there are multiple prior inconsistent judgments; and whether there

are any procedural opportunities available to the defendant in the second suit that were

unavailable in the first suit. Parklane Hosiery Co., Inc. v. Shore, 439 U.S. 322 (1979).

Very importantly, the doctrine of offensive non-mutual collateral estoppel generally does

not apply to the federal government. United States v. Mendoza, 464 U.S. 154 (1984).

34

(2) Inapplicability of Collateral Estoppel to the Vaccine Program.

Collateral estoppel is never appropriate in Vaccine Act cases. In Mendoza, the

Supreme Court held that non-mutual offensive collateral estoppel cannot be applied

against the federal government. Mendoza, 464 U.S. at 160. The United States is

inherently different than a private litigant due to the geographic scope and multiplicity of

its litigation. Id. Furthermore, government litigation frequently addresses legal

questions of substantial importance, and therefore allowing the United States to be

subject to estoppel would “thwart the development of important questions of law.” Id.

The bar on the application of collateral estoppel against the United States

includes Vaccine Program cases, despite petitioners’ policy arguments to the contrary.

Under Section 12(b)(1) of the Act, the Secretary of the Department of Health and

Human Services, a federal entity, is officially designated to defend against a petitioner’s

claim. 42 U.S.C. § 300aa-12(b)(1). Numerous vaccine cases have affirmed the

inapplicability of the collateral estoppel doctrine in this context. See, e.g., Bast v. Sec’y,

HHS, 117 Fed. Cl. 104, 124 n. 18, appeal dismissed sub nom., M.S.B. ex rel. Bast v.

Sec’y, HHS, 579 F. App’x 1001 (Fed. Cir. 2014); Stewart v. Sec’y, HHS, No. 06-777V,

2011 WL 2680580, at *2 (Fed. Cl. Spec. Mstr. June 15, 2011); Sharkey v. Sec’y, HHS,

No. 99-669V, 2010 WL 5507915, at *1 (Fed. Cl. Spec. Mstr. Dec. 10, 2010).

While there are some exceptions to the bar against collaterally estopping the

federal government,70 petitioners are unable to demonstrate that such circumstances

exist in their case. Claims authorized by the Vaccine Act are very fact-specific. “A

special master’s acceptance of a theory in one case does not require him or her to

accept the theory in subsequent cases involving similar facts or the same vaccine.

Rather, a different evidentiary record can lead to different outcomes.” Rickett v. Sec’y,

HHS, 468 Fed. Appx. 952, 959 (Fed. Cir. 2011). Given the varied nature of Vaccine Act

cases, and the ever-evolving medical and scientific evidence that informs their

resolution, collateral estoppel can never be appropriate. To determine otherwise would

“thwart the development of important questions of law by freezing the first final

decision.” Mendoza, 464 U.S. at 160. Thus, petitioners are unable to use the doctrine

of non-mutual offensive collateral estoppel against respondent in this case.

(3) Inapplicability of Judicial Estoppel to this Case.

Although it is abundantly clear that petitioners cannot invoke collateral estoppel

against respondent in this or any other case, I am unaware of any similar bar against

the application of judicial estoppel in Vaccine Act cases. See Vernacchio, 2015 WL

70For instance, the bar may not apply where the public policy considerations that favor suspension of

collateral estoppel are not present. See, e.g., N.L.R.B. v. Donna-Lee Sportswear Co., Inc., 836 F.2d 31

(1st Cir. 1987) (holding that the private interest of the parties predominates so the public policy

considerations were not valid). Similarly, the doctrine has been applied against the United States where it

was only a nominal party with no demonstrated direct interest in the subject matter of the suit. Westerchil

Const. Co., Inc. v. United States, 16 Cl. Ct. 727, 732-33 (1989).

35

1396357, at *5) (remarking that petitioners’ judicial “estoppel argument does not appear

to have been advanced in any Vaccine Program cases before.”). Nevertheless, for

reasons explained below, petitioners’ motion for judicial estoppel fails.

However, there are at least four reasons against applying judicial estoppel

against respondent in this case. First, and most importantly, judicial estoppel does not

apply when a claim has been settled. Petitioners seek to treat the statements contained

in respondent’s Poling Rule 4(c) report as a global concession (with respect to all

subsequent cases involving alleged preexisting mitochondrial disorders) of the first

prong of Althen. But petitioners have somehow missed an essential fact. Poling was

settled, not adjudicated, and “judicial estoppel does not apply where a party settles the

claim in which it is alleged to have made an inconsistent statement.” Moreland, 76 Fed.

Cl. at 295; see also United States v. International Bldg. Co., 345 U.S. 502, 506 (1953)

(holding that a settlement is not an adjudication on the merits and that applying judicial

estoppel in such a case “would serve an unjust cause: it would become a device by

which a decision not shown to be on the merits would forever foreclose inquiry into the

merits.”).

Second, petitioners have failed to satisfy the three requirements for the

invocation of judicial estoppel. Respondent’s position in this case is not “clearly

inconsistent” with her position in Poling. In Poling, respondent’s position was that the

child had sustained a Table injury within the timeframe established for both the MMR

and DTaP vaccinations, and thus presumptively should be compensated. Here, there is

no allegation that A.K. suffered a Table injury within the requisite time period. I also

note that the allegedly causal vaccine, influenza, was not associated with a Table

injury—nor was it even on the Vaccine Injury Table as a vaccine covered by the

Program—at the time that this claim was filed. Lacking an inconsistent position, there

can be no threat to judicial integrity.

Allowing respondent to argue against entitlement to compensation in A.K.’s case

in no way “create[s] the perception that either the first or the second court was misled.”

Moreland, 76 Fed. Cl. at 294 (quoting Cuyahoga, 65 Fed. Cl. 556). Moreover,

respondent derives no unfair advantage and imposes no unfair detriment on the

opposing party if not estopped. Id. Indeed, declining to apply judicial estoppel against

respondent in this case imposes no additional burden on petitioners; in order to

establish entitlement to compensation, they must either demonstrate that A.K. suffered

a Table injury or provide preponderant evidence that A.K.’s influenza vaccinations

actually caused his condition, using the framework established by Althen and its

progeny. Petitioners here are in precisely the same situation as all other Vaccine Act

claimants. Declining to provide them with special treatment does not constitute an

unfair burden.

Third, decisions issued by special masters and judges of the Court of Federal

Claims constitute persuasive, not binding, authority. Guillory v. Sec’y, HHS, 59 Fed. Cl.

121, 124 (2003), aff’d, 104 F. App’x 712 (Fed. Cir. 2004); Hanlon v. Sec’y, HHS, 40

Fed. Cl. 625, 630 (1998), aff’d, 191 F.3d 13444 (Fed. Cir. 1999). “Special masters are

36

neither bound by their own decisions nor by cases from the Court of Federal Claims,

except, of course, in the same case on remand.” Id. at 630. This is especially true in

cases like these which involve different vaccines (in the instant case, one without any

associated Table injury), a different clinical presentation, and different timing. Thus,

even if the causation theories in two cases are identical, another special master’s

determination about a petitioner’s causation theory does not compel me to reach an

identical conclusion.

Fourth and finally, a concession by respondent in one case does not constitute a

concession in another. Science and medicine are not immutable, and as the SCN1A

(Dravet syndrome) cases demonstrate,71 what was once viewed as a Table

encephalopathy is now known to be a genetic condition that cannot be compensated.

Evidence filed in one case may not be filed in another case. For example, a concession

that the measles vaccine can cause an encephalopathy occurring within 5 to 15 days of

a vaccination is not a concession that it can do so at times shorter or longer. Shyface v.

Sec’y, HHS, 165 F.3d 1344, 1351 (Fed. Cir. 1999) (quoting the legislative history of the

Vaccine Act asserting that a similarity to conditions or time periods in the Table would

not be sufficient to demonstrate vaccine causation). Thus, even if judicial estoppel

could be invoked against respondent based on the settling of the Poling case, it would

be impossible to do so here, where petitioners allege an entirely different vaccination

significantly aggravated their son’s condition.

c. Estoppel Motion Rejected.

Neither judicial nor collateral estoppel is appropriate in this case, and so

petitioners cannot compel respondent to admit their causation theory. Collateral

estoppel can never be appropriate in Vaccine Act cases. Judicial estoppel on the basis

of the Poling Rule 4(c) Report is inappropriate because the Poling case was not

adjudicated, because petitioners failed to satisfy the three requirements for the

invocation of the doctrine, because the decision of one special master is not binding on

other special masters, and because the vaccines and injuries alleged in the two cases

in question are completely different. For these reasons, petitioners’ motion for

estoppel is DENIED.

7. Motions Pertaining to Poling.

Because respondent affirmatively used the Poling Rule 4 report, Pet. Ex. 57, in

this case, it is admitted. The admission of Dr. Zimmerman’s expert opinion letter is

addressed in subsection II., below.

71 See Barclay v. Sec’y, HHS, 122 Fed. Cl. 189 (2015).

37

C. Motions to File Exhibits Out of Time.

1. Background.

Prior to the entitlement hearing in this case, I set a deadline of March 22, 2013,

for the filing of medical literature. Order, issued Feb. 21, 2013 (ECF No. 199). In

conjunction with this prehearing order, I included letters for each expert identified as

testifying, stressing the importance of providing supporting medical literature to counsel

for filing prior to the entitlement hearing in this case. See attachments to Prehearing

order, ECF No. 199.

On the day the medical literature was due, petitioners’ requested a four day

extension, indicating that they would be filling over 100 additional medical journal

articles. ECF No. 210. I granted their request, but warned them that I would not

consider additional literature filed after that date, absent a compelling reason. ECF No.

214. On March 26, 2013, petitioners filed over 100 medical journal articles. Less than

10% of these articles were actually discussed during the testimony or otherwise relied

upon at the hearing.

On April 24, 2013, while the hearing was on-going, petitioners requested leave to

file Pet. Ex. 240, a recently published medical journal article. I granted their request.

This article was discussed extensively during the hearing. Four days later, petitioners

requested to file another newly published journal article, Pet. Ex. 241. I likewise granted

this request.

Also during the hearing, petitioners provided copies of the slides that Dr. Deth

would be using to illustrate and supplement his testimony. See Pet. Exs. 239-40. The

slides referenced 25 medical journal articles that had not been filed in the case. I

therefore ordered petitioners to file all the journal articles thus referenced. When they

initially did so on May 31, 2013, they did not assign exhibit numbers to any of the

articles. Rather, they listed them by the slide number on which they appeared, referring

to page numbers of Pet. Ex. 239. I required petitioners to assign exhibit numbers to

each slide and to file an updated exhibit list. Order, issued Jun. 6, 2013 (ECF No. 270).

That exhibit list was filed on June 25, 2013 (ECF No. 271). Because the exhibits were

not re-filed, a chart reflecting the crosswalk between the articles and exhibit number is

set forth below.

38

ECF Ex. # in filing Redesignated Article Author and Short Title

No. Ex. #

260 Pet. Ex. 239, Slides Pet. Ex. 242 Numata, DNA Methylation Signatures

15, 44

260 Pet. Ex. 239, Slides Pet. Ex. 243 Colantuoni, Temporal dynamics

16, 45

260 Pet. Ex. 239, Slide 19 Pet. Ex. 244 Kiley, Exploiting Thiol Modifications

260 Pet. Ex. 239, Slide 22 Pet. Ex. 245 Kil, Regulation of Mitochondrial NADP+

260 Pet. Ex. 239, Slide 23 Pet. Ex. 246 Hurd, Complex I within Heart Mitochondria

260 Pet. Ex. 239, Slide 25 Pet. Ex. 247 Cy, Redox Basis of Epigenetic Modifications

260 Pet. Ex. 239, Slide 27 Pet. Ex. 248 Prozorovski, Sirt1

260 Pet. Ex. 239, Slide 35 Pet. Ex. 249 Castagna, Cerebrospinal fluid SAMe

260 Pet. Ex. 239, Slide 35 Pet Ex. 250 Sun, Imaging of Glutathione Levels

260 Pet. Ex. 239, Slide 47 Pet. Ex. 251 Csibra, Gamma Oscillations in Infant Brain

261 Pet. Ex. 239, Slide 51 Pet. Ex. 252 Andersson, Dopamine D4 Receptor Activation

261 Pet. Ex. 239, Slide 51 Pet. Ex. 253 Law, Neuregulin signaling in schizophrenia

261 Pet. Ex. 239, Slide 53 Pet. Ex. 254 Just, Cortical activation high-functioning ASD

261 Pet. Ex. 239, Slide 54 Pet. Ex. 255 Sun, Impaired Gamma-Band Activity in ASD

261 Pet. Ex. 239, Slide 57 Pet. Ex. 256 Frustaci, Oxidative stress-related biomarkers

261 Pet. Ex. 239, Slide 67 Pet. Ex. 257 Chez, Elevation of TNFα in CSF in ASD

261 Pet. Ex. 239, Slide 67 Pet. Ex. 258 Li, Elevated Immune Response in ASD Brains

261 Pet. Ex. 239, Slide 69 Pet. Ex. 259 Whitney, Inflammation in neurogenesis

261 Pet. Ex. 239, Slide 77 Pet. Ex. 260 Peake, Action of Anti-TNFα in Crohns

261 Pet. Ex. 239, Slide 78 Pet. Ex. 261 Graf, Gliadin Peptides in Celiac Disease

262 Pet. Ex. 239 Slide 84 Pet. Ex. 262 Yan, Reg T Cells & Glutathione Metabolism

262 Pet. Ex. 239 Slide 87 Pet. Ex. 263 Khan, Translocation of biopersistent particles

262 Pet. Ex. 239, Slide 89 Pet. Ex. 264 Schroder, NLRP3 Inflammasome:

262 Pet. Ex. 239, Slide 91 Pet. Ex. 265 Capuron, Immune System to Brain Signaling:

262 Pet. Ex. 239, Slide 92 Pet. Ex. 266 D’Mello, Cerebral Microglia Recruit Monocytes

I allowed respondent’s expert, Dr. Johnson, to address petitioners’ late-filed

medical literature. Post-Hearing Order, issued Sept. 9, 2013 (ECF No. 278). Then, in

an effort to ensure that both parties had an adequate opportunity to perfect their cases, I

allowed petitioners until October 9, 2013 to make any additional evidentiary filings they

desired; and gave respondent until November 8, 2013 to do the same. I indicated my

intent to close the record at that point, after which I would set a deadline for post-

hearing briefs. Id. Both parties made substantial use of the opportunity for additional

evidentiary filings. On November 15, 2013, I informed the parties that the evidentiary

record in this case was complete and ordered them to file post hearing briefs. Post

Hearing Order, issued Nov. 15, 2013 (ECF No. 282).

In various motions since, petitioners have requested that I admit additional

medical journal articles. Some have had only the most tenuous of relationships to the

matters presented at hearing. Others were available long before the record closed, but

were just “discovered” by petitioners. Most were cumulative of the matters addressed in

the volumes of medical literature already filed in this case, and only about 130 of the

approximately 280 medical journal or similar articles petitioners were filed were actually

mentioned in expert reports or discussed in testimony. Petitioners’ difficulty in keeping

track of exhibit numbers they have previously used contributes to the problems posed

39

by their late filings.72 See, e.g., Motion for Leave to File Exhibit 240, filed Jan. 14, 2014

(ECF No. 284) (re-using an exhibit number and refiled on Jan. 16, 2014 as Pet. Ex.

270); Motion for Leave to File Exhibits 240,73 271, 272, 273, 274, 275, 276, 278, 280,

281, and 282, filed Jun. 17, 2014 (ECF No. 303); Supplemental Motion for Leave to File

Exhibit 277 and 279, filed Jun. 26, 2014 (ECF No. 306). Petitioners also skipped over

numbers 267 and 268, so their proposed exhibit numbers jump from 266 to 269.

Many of the motions to admit this late filed medical literature have remained

pending. I rule on those motions now.

2. Legal Standards and Analysis.

When deciding whether new evidence justifies re-opening the record, special

masters have devised a four-factor test: “(1) the nature of the proffered new evidence;

(2) the prejudice to the parties; (3) the length of the delay; and (4) the reason for the

delay.” Vant Erve v. Sec’y, HHS, 39 Fed. Cl. 607, 612 (Fed. Cl. 1997), cited favorably

by Plavin v. Sec’y, HHS, 40 Fed. Cl. 609 (1998). Of these inquiries, the “paramount test

is the nature of the proffered new evidence.” Id. at 612. Special masters must consider

“the extent to which the new evidence is both relevant and affective of the outcome.” Id.

In instances where the proffered evidence “is of marginal relevance and impact,” the

moving party faces a significantly higher burden “with respect to the influence of the

remaining factors.” Id. at 612 (citing Horner v. Sec’y, HHS, 35 Fed. Cl. 23, 27 (1996)).

But the inverse is also true—if the proffered evidence is “highly relevant and clearly

outcome determinative…the importance of the remaining factors diminishes.” Plavin,

40 Fed. Cl. at 612 (citing Kaminski v. Sec’y, HHS, 39 Fed. Cl. 253 (1997).

Petitioners have not persuaded me that most of their new evidence justifies re-

opening the record. First, the additional evidence is cumulative in nature; the record

already contains many articles about mitochondrial disorders and brain development,

oxidative stress, and various biochemical abnormalities seen in ASD. Second, given

the number of articles already filed addressing these same issues, they are in no way

prejudiced by my declining to re-open the record months after I declared it closed. And

finally, several of the proffered articles were published well before the record was

closed. Petitioners’ lack of diligence in researching and identifying articles in a timely

fashion is not a sufficient reason to accept these articles into the record. Petitioners

could have filed them into the record long before I announced that the record was

closed. Petitioners’ failure to file them in a timely manner does not constitute a

justification to re-open the record.

72This remarkable level of disorganization is not uncommon in Mr. McHugh’s office. See Rodriguez v.

Sec’y, HHS, No. 06-559V, 2009 WL 2568468, at *23 (Fed. Cl. Spec. Mstr. Jul. 27, 2009) (where I

deducted several hundred dollars from an attorney’s fees decision “based on Mr. McHugh’s poor

performance in preparing and filing the exhibits in this case.”)

73Apparently petitioners’ counsel forgot that he had redesignated the Rose article, which reused Pet. Ex.

240 (previously assigned to the Wong article), as Pet. Ex. 270.

40

3. Granting in Part and Denying in Part Motions to File Late Exhibits.

Given that I had to read each of the journal articles to see if they contained the

smoking gun for which petitioners have been searching, it is simpler at this point to

admit all of the proffered exhibits, with the exception of Pet. Ex. 277, which is addressed

separately below. This is in keeping with the approach taken to other evidentiary issues

in Vaccine Act cases. It is rare, for example, for a Daubert motion to be granted, even

though the special master may ultimately chose to reject an expert’s opinion entirely in

reaching a decision. Unfortunately, it rewards petitioners’ disregard of my orders, which

were designed to allow this case to be resolved as fairly and expeditiously as possible.

I also note that medical literature not discussed by an expert is often of little utility, even

to a special master well-versed in the subject matter of the article.

I stress that none of these exhibits has had any impact on the causation decision

rendered in this case, but the time and effort required to apply the tests used to

determine whether they should be admitted would simply delay resolution of this case,

which has been pending for 12 years. As noted above, these late filed exhibits were

largely cumulative of other previously filed documents.74

Petitioners’ Ex. 277 was discussed extensively in Section II.B, above (in

conjunction with the motions to subpoena Dr. Zimmerman and for application of judicial

estoppel to this case). This letter constitutes a matter submitted by a party in another

Vaccine Act case and, as such, it falls under the protection of § 12(d)(4)(A). As

petitioners have not also filed the express written consent of the party submitting it, I

cannot admit it into the record of this case. I will not consider it as substantive evidence

in this case. The portions of this ruling that discuss the substance of the letter will

be redacted from public view.

Petitioners’ motions to file what had previously been identified as exhibits

238, 238A, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 250, 251, 252, 253, 254,

255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 265, 266, 269, 270, 271, 272, 273

274,75 275, 276, 278, 279, 280, 281, and 282 (chart filed June 16, 2014, at ECF No.

302), 274A (Funding Opportunity Announcement, filed June 17, 2014, at ECF No.

303),76 are GRANTED. Petitioners’ motion to file Pet. Ex. 277 is DENIED.

74In fact, most of the articles seem to relate to Dr. Deth’s presentation, which, as noted in the causation

decision, already cited many, many articles that were only tangentially related to his opinion. After

reviewing these late-filed articles, I concluded that petitioners’ flurry of late filings, relevant only at the

broadest levels, have not cured the core deficiencies in their experts’ theories.

75 Petitioners assigned exhibit number 274 to two exhibits. I designate the later-filed exhibit as “274A”.

I note that respondent’s objections to the relevance of this document are well-founded. Resp.

76

Response to Petitioners’ Motions, filed July 7, 2014, at 1-4 (ECF No. 308).

41

D. Motion to Exclude OAP Evidence.

1. Background.

By filing their short-form petition in 2003, petitioners in this case joined the OAP.

See Section I(A), supra. After first agreeing to be a test case for Theory 2, they

withdrew in April of 2008, both as a test case and from the OAP. See Motion to

Withdraw Claim as a Test Case, April 10, 2008 (ECF No. 40). While a part of the OAP

and while still a test case, respondent filed medical literature pertaining to the use of

video evidence in autism diagnosis and research (Res. Exs. A, C-E); the timing and

nature of early autism symptoms recognized by parents (Res. Ex. B); and regression in

autism (Res. Ex. F). These articles were filed primarily due to a dispute between the

parties about my order to petitioners to file video footage of A.K., with respondent

asserting the validity of the use of videos in diagnosis of ASD.

On February 25, 2008, also while this case was still designated as a test case,

respondent filed reports and CVs from her Theory 2 experts on general causation. See

Res. Exs. G-HH. (ECF No. 27). Two of the reports and accompanying CVs were later

withdrawn from the OAP Theory 2 cases, and from this case in particular, long after

petitioners had withdrawn as a Theory 2 test case. Of the remaining expert reports, two

involved experts who also testified in this case (Drs. Johnson and Jones) (Res. Exs. Q

and S, respectively. Another, Dr. Manuel Casanova, was the author of a medical

journal article that gave rise to Dr. Shafrir’s “triple hit” hypothesis. Still others, Drs.

Fombonne, Goodman, Lord, and Rutter, provided considerable information about

autism, regression in autism, and the epidemiology, matters highly relevant to

petitioners’ arguments about A.K.’s purported regression, the onset of his symptoms,

the clinical course of ASD, and whether there truly exists the “autism epidemic” about

which Dr. Shafrir testified in this case. The expert reports of Drs. Rodier and Kemper

addressed the prenatal origins of ASD, a matter highly relevant to evaluation of Dr.

Shafrir’s “triple hit” hypothesis, in which he asserted that events occurring in the second

or third year of life could be environmental triggers for regression and ASD. The report

of Dr. Rust, a pediatric neurologist and ASD specialist, on general causation was filed

on March 14, 2000, as Res. Ex. II. ECF No. 32. A case-specific expert report from Dr.

Rust was filed a few days later as Res. Ex. KK. ECF No. 35. Respondent’s Master List

of journal articles was filed on March 21, 2008, with the actual articles filed on a CD.

ECF No. 36.

Petitioners filed expert their OAP Theory 2 expert reports on March 20, 2008,

including a report by Dr. Deth, one of their experts at the hearing in this case. ECF No.

34. Petitioners have never moved to withdraw these three reports, although they did

request to withdraw Dr. Mumper’s report, filed earlier, and I granted that request.

In April 2008, petitioners withdrew as a test case, stating that they had decided

that A.K.’s case specific circumstances indicated that other causes might have

contributed to his ASD symptoms. However they noted that they might still rely to some

degree on the thimerosal causation theory: “By withdrawing his claim as a test case

42

petitioner [sic] does not mean to imply any waiver whatsoever of the claim that TCVs

contributed to his autistic symptoms; instead, petitioner [sic] withdraws his claim as a

test case because he seeks an opportunity to develop and present evidence of

additional and alternative causative factors.” Motion to Withdraw Claim as a Test Case,

filed Apr. 10, 2008; ECF No. 40 at 1.

The only additional evidence from the OAP filed into the record of this case were

transcripts of some of the testimony, including cross examination in the OAP test cases

from several of the experts whose reports were filed earlier into the record of this case.

See Res. Ex. LL, filed Oct. 11, 2011. ECF No. 145. These transcript excerpts were

filed in response to my order of July 12, 2011, for respondent to designate any OAP

hearing evidence on which she intended to rely in this case.

2. Petitioners’ Motion to Exclude OAP Evidence.

Petitioners’ April 2013 Motions in Limine included a motion to exclude evidence,

expert reports, medical literature, and witness testimony from the OAP. Id. at 20-25.

ECF No. 227. Petitioners correctly asserted that they were permitted to withdraw from

the OAP when I granted their motion to do so on April 15, 2008. Id. at 21. Further,

because their theory—that A.K.’s vaccination significantly aggravated an underlying

mitochondrial disorder—was not explored in the OAP, they argued that OAP evidence

should be excluded from their case. Id. at 22.

Petitioners relied on Paluck ex rel. Paluck v. Sec’y, HHS, 104 Fed. Cl. 457

(2012), a case in which the special master relied in part on evidence from the OAP to

decide a case which had not been part of the OAP. In Paluck, Judge Lettow expressed

his concern about this, commenting that the special master could not use his authority

“in a way that deprives a party of procedural rights provided by the Vaccine Act and the

Vaccine Rules.” Paluck, 104 Fed. Cl. at 484 (quoting Simanski v. Sec’y, HHS, 671 F.3d

1368, 1385 (Fed. Cir. 2012)).

Petitioners also contended that using OAP evidence in their case would violate

the Sixth Amendment’s confrontation clause. Motions in Limine at 24, n.13 (ECF No.

227).77

Respondent argued that petitioners voluntarily “availed themselves of the OAP

process,” which included the admission of OAP evidence into their case. Res.

Response at 4 (ECF No. 258). According to respondent, petitioners’ claim that the OAP

evidence was not relevant to their new theory does not constitute a basis to exclude the

evidence, because under the less stringent procedural rules and evidentiary practices

applied in the Vaccine Program, relevance affects the evidence’s weight, not its

77This argument is patently absurd. By its terms, the Confrontation Clause of the Sixth Amendment to

the U.S. Constitution applies only to criminal cases. The Vaccine Act does not even require hearings or

extend the right to cross-examine witnesses. § 12(d)(2)(D). I recognize that the issues in this case are

very emotionally charged for petitioners, but ridiculous arguments such as this one detract attention from

whatever merit their other arguments may have.

43

admissibility. See Moberly v. Sec’y, HHS, 592 F.3d 1315, 1325 (Fed. Cir. 2010); Munn

v. Sec’y, HHS, 970 F.2d 863, 871 (Fed. Cir. 1992).

In their Reply, petitioners renewed their motion to exclude OAP evidence, again

arguing that it is irrelevant. Pet. Reply at 13 (ECF No. 259). Petitioners called much of

the proffered testimony “irrelevant and outdated.” Id. Further, since petitioners have

were not claiming that thimerosal caused A.K.’s injury, they argued that all OAP

evidence regarding thimerosal or mercury toxicity should be struck from the record. Id.

at 14. They went on to claim that “any neurologist or pediatrician who testified as an

expert in the field in 2008 that [an ASD] epidemic did not exist is not credible,” and thus

the testimony of Drs. Eric Fombonne and Max Wiznitzer’s and their expert opinions

should be struck from the record.78 Id. at 15-17.

Petitioners also claimed that the Vaccine Act “requires that any condition

asserted in a vaccine case be supported in the medical record” and therefore that any

testimony that A.K. exhibited symptoms of ASD that was not supported in the medical

records was irrelevant. Motions in Limine at 16. They requested that the testimony of

Dr. Bennett Leventhal be struck because he discussed tests that were conducted on a

child in the OAP test case, not A.K.79 Id. at 18.

3. Legal Standards.

Special masters have “virtually unlimited” power to “inquire into matters relevant

to causation.” Snyder, 2009 WL 332044, at *2; Whitecotton v. Sec’y, HHS, 81 F.3d

1099, 1108 (Fed. Cir. 1996). Congress “contemplated that the special masters would

develop expertise in the complex medical and scientific issues involved in actual

causation claims and would then apply this expertise to the resolution of other cases.”

Snyder, 2009 WL 332044, at *2. This policy favoring broad inclusion of evidence is

echoed in the Vaccine Rules, which instruct special masters that they are “not…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.” Vaccine Rule

8(b)(1).

4. Analysis.

Unlike Paluck, this is not a case where evidence was imported by the special

master from the OAP for use in a case that was not a part of the OAP. The evidence

78That petitioners and their expert, Dr. Shafrir, reject the epidemiological evidence proffered in the test

cases is clear. That disagreement does not give them the authority to control the admissibility of such

evidence. Doctor Shafrir’s opinions on the mainstream approach to ASD’s diagnosis, treatment, and

causes, are discussed at some length in the causation decision in this case. Doctor Shafrir’s opinions

that there is an autism epidemic caused by postnatal environmental factors such as vaccines is rebutted

by the scientific evidence contained in the reports and testimony of these ASD experts from 2008, as well

as the testimony and reports specific to this case.

79I have not relied in any way on Dr. Leventhal’s testimony contained in Res. Ex. LL, but “striking” it is

unnecessary.

44

petitioners seek to exclude, on the dubious basis that all of the evidence in the OAP is

somehow irrelevant to their case, was actually filed into the evidentiary record in this

case. Regardless of their source, the expert reports, transcripts, and medical journal

articles filed are evidence in this case. Petitioners were well aware of what the

evidentiary record included; they cannot claim surprise or a lack of opportunity to

respond to this evidence.

The timing for their motion to exclude this evidence is highly suggestive of

gamesmanship. The motion was filed on April 8, 2013. ECF No. 227. I had earlier

extended the deadlines for all pre-evidentiary findings (at petitioners’’ request) with

respondent’s deadline extended to April 1, 2013. Thus, the exclusion of evidence would

effectively preclude respondent filing similar evidence from another source. And, if I

delayed the case to allow them to obtain additional evidence, respondent could simply

file new reports from the same experts or even the same reports again. Neither

scenario would have worked to petitioners’ advantage.

The OAP evidence not specifically filed into the docket of this case was made

publically available in the OAP test case dockets. The transcripts of the hearing

testimony were likewise made publically available. While, due to copyright restrictions,

the medical and scientific journal articles themselves were not available on the OAP

docket (http://www.cofc.uscourts.gov/docket-omnibus-autism-proceeding), the master

lists of these articles were publically available, and respondent’s Master List, including

all of the medical journal articles on that list, was actually filed into the record of this

case.80 Finally, and most significantly, the detailed and comprehensive decisions of the

special masters were drafted with the purpose of setting forth the available and relevant

evidence for the purpose of not only resolving the specific test cases, but to create a

body of evidence that would aid in resolving the remaining cases.81 Nevertheless, with

the exception of occasional citations to the test case decisions, this evidence was not

used to resolve this case.82 This obviates any need to determine whether OAP

80The causation decision in this case does not rely on any medical journal article not filed into the record

of this case.

81 Although the parties were able to supplement OAP evidence with additional materials, there is nothing

in Autism General Order #1 to suggest that OAP evidence should be excluded from subsequent cases.

Had the OAP produced a ruling on general causation issues favorable to petitioners, they would have

been “ordered to demonstrate that [their] case qualifies for compensation under the general ruling.”

Autism General Order #1 at 6-7. Because the OAP general causation rulings were unfavorable to

petitioners’ case, they received “the opportunity to introduce additional supportive case-specific

evidence.” Id.

82 There exists one limited exception, which involves Dr. Deth. When petitioners indicated that they

intended to use Dr. Deth as one of their experts in this case, I cautioned them that I did not intend to

permit the re-litigation of the theories he had presented in the Theory 2 OAP test cases, absent new

evidence suggesting that the prior resolution was incorrect. I noted that the evidence he presented in the

Theory 2 test cases was not well-received, and urged them to look at the test case decisions before

retaining Dr. Deth. Doctor Deth’s expert report in the OAP was already a part of the record in this case.

When he testified in this case, I recognized that many of the PowerPoint slides he was using were the

same slides he had used during his earlier testimony, to include an illustration from a 1958 medical

journal article purporting to show evidence for a “block” in the transsulfuration cycle in the human brain.

Thus, I have used my own knowledge of Dr. Deth’s testimony in both the test cases and A.K.’s case, as

45

evidence can be used in other cases that were once a part of the OAP.83

Perhaps the most disturbing aspect of petitioners’ request to exclude is that

granting it would, in effect, give petitioners control over the source of any evidence

respondent might file. Petitioners were as free as respondent to file information from

the OAP—and, through the testimony of Dr. Deth, they did so.

Although petitioners claimed that they were not relying on a mercury theory of

causation any longer (a matter not clear until they filed their second amended petition

and which they had expressly reserved the right to do in withdrawing from the OAP), Dr.

Deth talked about mercury on his slide presentation and during his testimony at the

hearing in this case. Additionally, A.K.’s medical records from Dr. Boris reflected that he

was chelated to remove mercury and other “toxic metals” from his body, and reflected

Dr. Boris’s diagnoses related to these matters. While it is undoubtedly true that some of

the matters filed by respondent from the OAP were not precisely relevant to A.K.’s case,

the advantage of a bench trial is that the special master may simply disregard irrelevant

matters after the hearing and post-hearing processes are complete without having to

determine, in advance of hearing the testimony, what is relevant and what is not.

Generally, “in omnibus proceedings, the parties consent to import evidence from

the ‘test case’ into other individual cases.” Snyder, 2009 WL 332044, at *2 n.8. Here,

petitioners voluntarily agreed to join the OAP. While their case was part of it, they

benefitted from the coordinated litigation efforts of the PSC and the development of new

scientific studies. As part of their agreement, they consented to the inclusion of OAP

evidence in their case. The fact that petitioners later withdrew from the OAP is of no

consequence, because the evidence to which they object is already part of the record in

their case.

well as both of his expert reports in assessing to what degree such testimony overlapped and where it

was distinct. I note that I was concerned enough about the lack of support for Dr. Deth’s opinions, his

practice of cherry-picking data from other researchers, and his misstatements about the findings of other

researchers, and his tendency to offer opinions on matters in which he was not qualified to opine in the

OAP to decline to award interim fees and costs for Dr. Deth’s expenses when I made the first interim fees

award in this case.

83 In one sense, the OAP ended when the PSC disbanded after the conclusion of the appellate

proceedings in the test cases. See Autism Update, Jan. 12, 2011, available at

http://www.cofc.uscourts.gov/docket-omnibus-autism-proceeding (noting the disbandment of the PSC). In

another, based on the intent of the parties when it was created and the purposes behind its creation, all of

the cases that were once a part of the OAP are affected by the evidence created in the test cases. As

Autism General Order #1 indicates, at the time the OAP was created, petitioners acknowledged that there

was insufficient evidence to prove vaccine causation of ASD, but averred that the evidence was

obtainable through a discovery process. Thus, petitioners, including petitioners in the instant case,

whose cases were subject to dismissal for lack of evidence of causation at the time they were filed

achieved a lengthy period of delay. Petitioners in this case were the beneficiaries of that period of delay. It

is highly unlikely that respondent would have entered into the agreement to create an omnibus proceeding,

absent the understanding that the evidence would be available for use in other cases that

were not only once a part of the OAP, but relied on some of the same theories that were presented in the

OAP. This is particularly true in this case, given Dr. Deth’s opinions, testimony, and supporting slides and

literature.

46

Petitioners have cited no authority that compels or persuades me to remove

evidence that is already part of the record. Anything filed into the docket in A.K.’s case

while it was part of the OAP that was not subsequently withdrawn on motion by one of

the parties remains part of the record. This includes, inter alia, the reports and CVs

from some 13 experts regarding general causation issues.

5. Ruling on Motion to Exclude Evidence.

All of the evidence filed into the record of this case not specifically excluded (by

an earlier order or the granting of an earlier motion to withdraw it) remains a part of the

evidentiary record. The Vaccine Rules favor broad inclusion, and “the probative value

of the evidence or the credibility of the witnesses…are matters within the purview of the

fact finder.” Munn, 970 F.2d at 871. To the extent that petitioners’ motion to exclude

evidence refers to OAP evidence not in the record of this case, it is effectively moot. As

noted above, the causation decision in this case does not rely on any medical literature

not filed in this case. And, although the relationship between Dr. Deth’s testimony in the

OAP and his testimony in the instant case is highly complex, I stress that discussion of

Dr. Deth’s prior OAP opinion pertains to Dr. Deth’s own testimony in this case and my

conclusions regarding Dr. Deth’s qualifications and reliability as an expert, and not as

substantive evidence.84

E. Substitution of Child Development Ex

This text is long and has been trimmed here. Open the source document for the complete record.