Mostovoy v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: February 4, 2016

* * * * * * * * * * * * * * * PUBLISHED
JOANN MOSTOVOY and VADIM *
MOSTOVOY, in their own right and as *
Best friends of their son, V.J.M., *
* No. 02-010V
Petitioners, *
*
v. * Chief Special Master Dorsey
*
SECRETARY OF HEALTH * Discovery; Vaccine Rule 7;
AND HUMAN SERVICES, * Vaccine Safety Datalink (“VSD”);
* Due Process.
Respondent. *
* * * * * * * * * * * * * * *

ORDER1 DENYING PETITIONERS’ RENEWED MOTION FOR DISCOVERY2

I. Introduction

On January 2, 2002, Joann and Vadim Mostovoy (“petitioners”) filed a petition for
compensation under the National Vaccine Injury Compensation Program (“the Program”), as the
legal representatives of their son, V.J.M., in which they allege that the measles, mumps and
rubella (“MMR”) vaccination V.J.M. received in January 1999 caused him to develop autism or
autism spectrum disorder (“ASD”). Since the original filing of petitioners’ petition, 20 other
petitioners, all with similar factual allegations, have joined the Mostovoy petitioners in an
omnibus proceeding. See Order dated April 15, 2003. Collectively, petitioners assert as their
theory of causation that V.J.M. had an adverse reaction to the human DNA contained in the
MMR vaccine, which triggered his ASD. Petitioners’ Amended Petition dated June 10, 2011,
(ECF No. 42), ¶16 at 5.

1
This Order will not be filed in the other omnibus cases, as petitioners only filed their Renewed
Motion for Discovery in the Mostovoy (02-10v) case.
2
Because this published Order contains a reasoned explanation for the action in this case, the
undersigned intends to post it on the United States Court of Federal Claims' website, in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal
Management and Promotion of Electronic Government Services). In accordance with Vaccine
Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information,
the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review,
the undersigned agrees that the identified material fits within this definition, the undersigned will
redact such material from public access.
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 On February 3, 2012, petitioners filed their first motion to compel discovery seeking
access to the Vaccine Safety Datalink (“VSD”) and requested that subpoenas be issued to ten
different managed care organizations (“MCOs”).3 See Petitioners’ Motion to Compel dated Feb.
3, 2012, (“Motion to Compel”) (ECF No. 46). Both respondent and the MCOs filed briefs
opposing petitioners’ motion for discovery. Respondent’s response highlighted the plethora of
problems associated with the Motion to Compel, including that petitioners’ request was
overbroad, burdensome, unreasonable, and unnecessary to prove their case. Respondent’s
Response to Motion to Compel dated March 30, 2012, (ECF No. 58).

Petitioners’ Motion to Compel was denied in a lengthy and comprehensive order by then-
Chief Special Master Patricia Campbell-Smith.4 See Order dated June 12, 2013, (ECF No. 78).
The next day, the case was transferred to Special Master George Hastings, and petitioners filed a
motion for reconsideration of the Chief Special Master’s order. Motion for Reconsideration
dated July 12, 2013, (“Motion for Reconsideration”) (ECF No. 82). Petitioners’ Motion for
Reconsideration was denied by Special Master Hastings, who agreed with Chief Special Master
Campbell-Smith that petitioners’ discovery request was neither reasonable nor necessary. See
Order dated October, 24, 2013, (ECF No. 93).

On October 1, 2015, petitioners renewed their motion to compel, again seeking access to
the VSD and to issue subpoenas to the MCOs. Motion for Discovery dated October 1, 2015,
(“Renewed Motion to Compel”) (ECF No. 164). For the reasons described below, the
undersigned DENIES petitioners’ Renewed Motion to Compel. The undersigned agrees with
the previous decisions of then-Chief Special Master Campbell-Smith and Special Master
Hastings and incorporates their reasoning herein. This order will only address the new
arguments raised by petitioners in the Renewed Motion to Compel.

II. Legal Standard

Pursuant to the Vaccine Rule 7(a), “[t]here is no discovery as a matter of right” in
Program cases. The Vaccine Act further provides that “[t]here may be no discovery … other
than the discovery required by the special master.” 42 U.S.C. § 300aa-12(d)(ii)(B)(v). A special
master:

(i) may require such evidence as may be reasonable and necessary,
(ii) may require the submission of such information as may be reasonable and
necessary, [and]

3
As former Chief Special Master Campbell-Smith noted in her June 12, 2013 Order, “[b]ecause
a portion of the VSD Project data is in the possession of the Centers for Disease Control and
Prevention (“CDC”), and another portion is in the possession of the ten private MCOs,
petitioners filed dual motions: one to compel discovery of CDC as a party and the other to issue
subpoenas to the ten MCOs as multiple non-parties.” Order dated June 12, 2013, (ECF No. 78).
4
Judge Campbell-Smith was appointed Judge of the United States Court of Federal Claims on
September 19, 2013. On October 21, 2013, President Obama designated her as Chief Judge.
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 (iii) may require the testimony of any person and the production of any documents as
may be reasonable and necessary.

§ 300aa-12(d)(3)(B).

III. Petitioners’ New Arguments in Their Renewed Motion for Authority to Issue
Subpoenas and to Compel Access to the Vaccine Safety Data Link

In the Renewed Motion to Compel, petitioners raise two new arguments. First,
petitioners state that the criticism of respondent’s expert, Dr. Fallin, of Dr. Deisher’s research
entitles petitioners access to the VSD. Renewed Motion to Compel at 2-5. Secondly, petitioners
argue that the VSD constitutes the best evidence available to petitioners and thus due process
protects petitioners’ rights to access the information. Id. at 28. The undersigned discusses each
of these arguments in turn.

a. Petitioners’ argument that respondent’s expert’s criticism of Dr. Deisher’s
research does not entitle petitioners access to the VSD

The first basis for petitioners’ Renewed Motion to Compel “is that respondent has taken a
position through the opinion of her expert … that petitioners’ theory of causation fails not
because of petitioners’ expert’s analysis but because the data on which she has relied is
insufficient.” Renewed Motion to Compel at 1-2 (referencing Resp’s Ex. J, Dr. Fallin’s expert
report). Petitioners claim that respondent attacks Dr. Deisher’s work as insufficient while
denying her access to the data that allegedly could provide proof of petitioners’ causation theory.
Id. at 2. Petitioners further argue that respondent “attacks the validity of the only data available
to petitioners. The best means of countering the respondent’s argument is granting access to
petitioners to data that is within respondent’s control.” Id. Petitioners’ counsel quotes
respondent’s expert, Dr. Fallin, as claiming that the “only study that can be free of the potential
for statistical fallacy is one keyed to individual medical records. The only such data set known
to exist is the [VSD].” Pet’rs’ Reply at 1. Petitioners also insist that their causation theories
could be made “more reliable” if they had access to the VSD.

As then-Chief Special Master Campbell-Smith and Special Master Hastings have both
previously explained, however, it is not appropriate for the court to grant petitioners’ motion to
access the VSD when there are established protocols for accessing this information.5 Indeed, the
undersigned notes that experts and scientists may gain access to the VSD by following the
protocols set up by the CDC to gain access to this data. To allow petitioners and their experts to
gain access by court order circumvents established protocols, rules and regulations that apply to
all interested parties and protects the data contained in the VSD.

Further, Dr. Fallin’s criticism of Dr. Deisher’s study does not entitle petitioners to access
the VSD data. Dr. Fallin states, “[t]here are several major weaknesses of [Dr. Deisher’s] study,

5
See U.S. National Center for Health Statistics, Centers for Disease Control, Procedures & Costs
for Use of the Research Data Center, App. IV Vaccine Safety Datalink (VSD) Data Sharing
Program (2005); see also Order dated June 12, 2013, (ECF No. 78) at 8-9.
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including its ecological study design, its reliance on inappropriate assumptions, and its grossly
over-stated conclusions in light of the evidence presented.” Resp’s Ex. J at 2. It is common, if
not routine, for an expert to criticize the opposing expert in litigation, as well as any studies or
research authored by the expert. In every hearing over which the undersigned has presided,
experts have criticized the opposing experts and have testified about the inadequacy of studies
presented in medical journal articles, or research performed by the opposing expert, similar to
what Dr. Fallin has done here.

Moreover, there are many studies and investigations related to the question of whether
injuries and illnesses are vaccine-related that do not rely on data from the VSD. Here, the
petitioners are not limited to the VSD. In fact, petitioners concede that the VSD is not the only
evidence available. See Renewed Motion to Compel at 2, footnote 2. Cases in the Program
routinely proceed to resolution without VSD information or evidence. The undersigned is not
aware of any case in the Program where an expert has been given access to the VSD through a
court order for the purpose of performing research to establish evidence in support of a medical
theory.

b. There is No Violation of Due Process

Secondly, petitioners argue that the VSD is the “best available source of information” and
“the best evidence available” to allow petitioners to prove their medical theory of causation.
Renewed Motion to Compel at 2. Petitioners insist that a denial of their motion would result in a
violation of their due process rights, stating that “[d]iscovery [in the Vaccine Program] may be
discretionary with the Special Master, but in this extreme case it is mandated by the overriding
requirement that no matter the details, even Congress may not deny a litigant, within the borders
of this nation, due process of law.” Renewed Motion to Compel at 5. Petitioners cite only one
case, Greater Baltimore Center for Pregnancy Concerns, Inc. v. Mayor and City Council of
Baltimore, 721 F.3d 264 (4th Cir. 2013), in support of their argument that due process protects
their right to the discovery they seek.

In Greater Baltimore, the Fourth Circuit determined that the trial court had not given the
City of Baltimore sufficient time to conduct discovery, and thus, there was a violation of due
process. 721 F.3d at 280. The Court did not, however, mandate specific discovery such as that
sought here, only the opportunity to conduct discovery. The holding related to discovery in
Greater Baltimore does not apply here, where petitioners have been given ample time to conduct
discovery, and where in fact, petitioners have conducted extensive discovery6, filing more than
five expert reports, numerous medical records, and over 355 medical articles.

To repeat, there is no right to discovery in the Vaccine Program. See Vaccine Rule 7(a).
Special masters are not governed by the Federal Rules of Civil Procedure, which were at issue in
Greater Baltimore. Instead, discovery in the Vaccine Program is permitted to the extent that the
evidence at issue is deemed to be reasonable and necessary. 42 U.S.C. § 300aa-12(d)(3)(B)(i).
Here, there has been no showing by the petitioners that the information that petitioners seek in
order to evaluate their claims for compensation under the Vaccine Act is necessary for the
undersigned to consider. Further, petitioners’ argument that a denial of their motion constitutes a

6
To date, 629 exhibits have been filed.
4
violation of their due process rights fails because there exists a “procedure” to request the
discovery they seek, and that procedure has been followed. The fact that the specific discovery
request was denied is not itself a due process violation.

The undersigned’s task in presiding over this Omnibus proceeding is to adjudicate these
cases in accordance with the statutory scheme set forth in the Vaccine Act, codified at 42 U.S.C.
§ 300aa et seq., to determine whether petitioners are entitled to compensation for a vaccine-
related injury. The statute provides that the undersigned should base her decision on pre- and
post-injury medical records, vaccination records, provider notes, test results, and expert medical
opinions. 42 U.S.C. § 300aa-13(b). The statute does not give the special master authority to
grant the parties discovery for the purpose of conducting vaccine research. See Werderitsh v.
Sec’y of Health & Human Servs., No. 99-310V, 2005 WL 3320041 (Fed. Cl. Nov. 10, 2005).
Legislative history “suggests[] that the special master’s investigative power is limited to ‘factual
elements’ of a petitioner’s claim.” H.R. Rep. No. 99-908, pt. 1, at 17 (1986), reprinted in 1986
U.S.C.C.A.N. 6287, 63447.

Thus, in the special master’s view, the Program is not the appropriate forum for –
and a special master should not preside over wide-ranging discovery, or should
not devise unique procedures, aimed at – developing original scientific or medical
theses. Indeed, scientific or medical ‘research’ conceived and conducted in the
context of litigation poses an inherent danger: scientific or medical ‘research’
conceived and conducted in the context of litigation is not subjected usually to the
time-honored practices in the scientific and medical communities of peer-review
and of publication – two of several, significant touchstones of evidentiary
reliability (citations omitted).

Schneider v. Sec’y of Health & Human Servs., No. 99-160V, 2005 WL 318697, at *5 (Fed. Cl.
Spec. Mstr. Feb. 1, 2005), aff’d by 64 Fed. Cl. 742 (2005).

IV. Conclusion

For all of the foregoing reasons, petitioners’ Renewed Motion to Compel discovery is
DENIED.

IT IS SO ORDERED.

s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master

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