The opinion
United States Court of Federal Claims
No. 15-200V
(Filed Under Seal: March 19, 2018)
Reissued: April 6, 20181
)
MARIO CARUSO, )
)
Petitioner, )
)
Vaccine Case; Motion for Review;
v. )
Influenza Vaccine; Althen; Burden of
)
Proof
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
OPINION
Ronald Craig Homer, Conway, Homer, P.C., Boston, MA, for petitioner.
Darryl R. Wishard, Vaccine/Torts Branch, Civil Division, United States Department of Justice,
Washington, DC, for respondent.
SMITH, Senior Judge:
Petitioner, Mario Caruso, seeks review of a decision issued by Special Master Brian H.
Corcoran denying his petition for vaccine injury compensation. Petitioner brought this action
pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 et seq.
(2012), alleging that petitioner developed acute disseminated encephalomyelitis (“ADEM”) as a
result of the trivalent influenza vaccine he received on October 16, 2012. The Special Master
denied compensation, finding that petitioner had not met his burden of proof. Caruso v. Sec’y of
Health & Human Servs., 2017 WL 5381154 (Fed. Cl. Spec. Mstr. Oct. 18, 2017) (Caruso).
Petitioner now moves for review of this decision. For the reasons that follow, the Court
DENIES his motion.
1
An unredacted version of this opinion was issued under seal on March 19, 2018. The
parties were given an opportunity to propose redactions, but no such proposals were made.
I. BACKGROUND
A brief recitation of the facts provides necessary context.2
Mr. Caruso received the flu vaccine on October 16, 2012, when he was 64-years-old.
Prior to receiving the vaccine, his medical history included prostate enlargement,
hypolipoproteinemia,3 varicose veins of the lower extremity with an ulcer, and sclerosis of the
skin.4 Subsequent to receiving the vaccine, Mr. Caruso’s medical evidence did not indicate any
immediate reaction to the vaccine for the 10 weeks following vaccination. On October 23, 2012,
Mr. Caruso visited a physician at the Peachwood Medical Group (“PMG”) to have his lipid
levels checked, at which point he did not report any neurological issues or other symptoms.
At trial, Mr. Caruso’s wife, Sylvia Caruso, testified that she noticed changes in Mr.
Caruso’s behavior around November 2012. Specifically, she stated that he struggled to move
large items and began having difficulty with his vision during that period. She then testified that
things progressively worsened and that petitioner started walking in an unstable way around the
end of December 2012.
In late January of 2013, Mr. Caruso began seeking medical attention after he experienced
a more acute incident, wherein he was shopping and his feet suddenly started to drag and he
displayed an uneven gait like a “drunken sailor.” On January 28, 2013, petitioner had an
appointment with his nurse practitioner at PMG, at which he stated that he had been sporadically
“walking funny,” falling asleep in the evenings, and felt off balance, but denied paresthesia.5
These medical records did not indicate that Mr. Caruso had been experiencing any symptoms
prior to December 2012. Additionally, he denied experiencing blurred vision, double vision,
photophobia,6 headaches, and weakness. His exam results were deemed normal, but the nurse
practitioner indicated that Mr. Caruso seemed “to slightly drag right tow [sic]. No specific
abnormality but gait does not seem totally normal.” Petitioner was diagnosed with dizziness and
2
As the basic facts here have not changed significantly, the Court’s recitation of the
background facts here draws from the Special Master’s earlier opinion in Caruso.
3
Hypolipoproteinemia is “the presence of abnormally low levels of lipoproteins in the
serum, as in hypobetalipoproteinemia and Tangier disease.” Dorland’s Illustrated Medical
Dictionary 903 (32nd ed. 2012) (“Dorland’s”).
4
A varicose vein is “a dilated tortuous vein, usually in the subcutaneous tissues of the leg,
often associated with incompetency of the venous valves.” Dorland’s at 2036. A varicose ulcer
is “an ulcer on the leg due to varicose veins, such as a stasis ulcer.” Id. at 1998. Sclerosis of the
skin is “an induration or hardening, such as hardening of a part from inflammation, increased
formation of connective tissue, or disease of the interstitial substance.” Id. at 1680.
5
Paresthesia is “an abnormal touch sensation, such as burning, prickling, or formication,
often in the absence of an external stimulus.” Dorland’s at 1383.
6
Photophobia is “abnormal visual intolerance of light.” Dorland’s at 1441.
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a gait disorder, and diagnostic tests were ordered. A CT scan from February 1, 2013 found no
significant abnormalities, and the results were deemed “unremarkable.”
Mr. Caruso was again seen at PMG on February 8, 2013, complaining of dizziness,
diplopia,7 and gait difficulty. He was referred to a neurologist. On February 11, 2013, petitioner
met with Dr. Loveneet Singh, at which point he complained of fatigue, vision changes, and gait
problems. During the visit he displayed impaired coordination and diplopia, an inability to
perform rapid alternating movements, a slow gait, and a need for support when walking. Dr.
Singh opined that Mr. Caruso demonstrated evidence of upper motor neuron dysfunction,
including cerebellar signs and gait ataxia.8 Brain and cervical spine MRIs performed on March
2, 2013, showed multifocal signal abnormalities in the midbrain, brainstem, brachium pontis,
cerebellum, and spinal cord. Some of the lesions enhanced,9 and some cerebral volume loss was
noted. The MRIs also showed both enhancing and non-enhancing signal abnormalities. There
also appeared to be evidence of active inflammation on petitioner’s spine, which suggested
“active demyelinated plaques with breakdown of the blood brain barrier.”
Mr. Caruso again met with Dr. Singh on March 11, 2013, at which point ADEM10 and
multiple sclerosis11 (“MS”) were included in his differential diagnosis. Dr. Singh ordered more
testing, including lab work of petitioner’s glucose and protein levels, a cell count, and an MS
panel. The results of the testing were relatively normal, with no evidence of oligoclonal bands12
and a negative MS panel.
7
Diplopia is “the perception of two images of a single object . . . .” Dorland’s at 525.
8
Ataxia is the “failure of muscular coordination; irregularity of muscular action.” Dorland’s
at 170.
9
A lesion is “any pathological or traumatic discontinuity of tissue or loss of function of a
part. Dorland’s at 1025.
10
Acute disseminated encephalomyelitis (“ADEM”) is “an acute or subacute
encephalomyelitis or myelitis characterized by perivascular lymphocyte and mononuclear cell
infiltration and demyelination; it occurs most often after an acute viral infection, especially
measles, but may occur without a recognizable antecedent. It is believed to be a manifestation of
an autoimmune attack on the myelin of the central nervous system. Symptoms include fever,
headache, and vomiting; sometimes tremor, seizures, and paralysis; and lethargy progressing to
coma that can be fatal. Many survivors have residual neurologic deficits.” Dorland’s at 613.
11
Multiple sclerosis is “a disease in which there are foci of demyelination throughout the
white matter of the central nervous system, sometimes extending into the gray matter; symptoms
usually include weakness, incoordination, paresthesias, speech disturbances, and visual
complaints. The course of the disease is usually prolonged, so that the term multiple also refers to
remissions and relapses that occur over a period of many years.” Dorland’s at 1680.
12
Oligoclonal means “pertaining to or derived from a few clones.” Dorland’s at 1317.
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Additionally on March 11, 2013, petitioner visited Dr. Gary Walters, an ophthalmologist,
at Eye Medical Center in Fresno, California. Dr. Walters noted in his records that petitioner’s
sudden onset of double vision and walking difficulties were reported to have begun two months
prior, in January 2013. At this appointment, Mr. Caruso showed decreased vision (right eye
20/200; left eye 20/70), but those symptoms showed improvement throughout 2013.
Petitioner again visited Dr. Singh in July 2013, at which point the ADEM diagnosis was
confirmed, but nothing in the medical records indicated that the flu vaccine played a part in its
development. After a year of ongoing symptoms with no signs of progression in severity or
evidence of additional developing lesions, Mr. Caruso sought a second neurological opinion. He
saw Dr. Leslie Dorfman at the Stanford Hospital in Redwood City, California on June 23, 2014.
Dr. Dorfman reviewed petitioner’s MRIs and agreed that they were not indicative of MS. Dr.
Dorfman also opined that ADEM was an “acceptable working diagnosis,” but that he ultimately
felt the true diagnosis for petitioner’s symptoms remained unidentified.
Petitioner returned to Dr. Dorfman on July 25, 2014, at which point Dr. Dorfman noted
that recent testing produced negative or normal results. Dr. Dorfman then opined that Mr.
Caruso was likely suffering from an “atypical form” of ADEM, offering no signs as to its
etiology, and he recommended that petitioner undergo steroid treatment, followed by IVIG13 if
the steroids proved ineffective. By August, petitioner reported improvement from the steroid
treatment, and Dr. Dorfman proposed its continuation.
Additional medical records indicate that Mr. Caruso has continued to experience
sequelae14 from his 2012-13 symptoms. Some records suggest a relationship between the flu
vaccine and petitioner’s symptoms, but those records memorialize representations made by
petitioner, rather than provide contemporaneous information provided to treaters when Mr.
Caruso began seeking treatment in January 2013. MRIs from April 2015 confirm that no
additional lesions have appeared since 2013, further corroborating the accuracy of the ADEM
diagnosis.
13
Intravenous immunoglobulin (“IVIG”) is a blood product used to treat patients with
antibody deficiencies, including neurological disorders. Decision, at 6 (citing Clinical Uses of
Intravenous Immunoglobulin, NCBI (2005),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1809480/ (last visited on Aug. 28, 2017)).
It is commonly prescribed to treat diseases believed to be autoimmune in nature, increasing the
effectiveness of an individual’s immune response. Id.
14
Sequelae are “any lesion[s] or affection[s] following or caused by an attack of disease.”
Dorland’s at 1696.
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On November 24, 2015, petitioner filed the expert report of Dr. Carlo Tornatore.15 On
June 16, 2016, respondent filed the expert report of Dr. Thomas Leist.16 An entitlement hearing
was held on April 21, 2017, and Special Master Corcoran denied petitioner’s claim on October
18, 2017, finding that there was insufficient evidence to support an award of compensation.
Decision of the Special Master (hereinafter “Dec.”) at 22. Petitioner filed his Motion for Review
(hereinafter “MFR”) on November 17, 2017. Respondent filed its Response to petitioner’s
Motion for Review (hereinafter “Resp. to MFR”) on December 18, 2017. Petitioner’s Motion is
fully briefed and ripe for review.
II. STANDARD OF REVIEW
Under the Vaccine Act, this Court may review a special master’s decision upon the
timely request of either party. See 42 U.S.C. § 300aa-12(e)(1)-(2). In that instance, the Court
may: “(A) uphold the findings of fact and conclusions of law. . . , (B) set aside any findings of
fact or conclusion of law. . . found to be arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law. . . , or, (C) remand the petition to the Special Master for
further action in accordance with the court’s direction.” Id. at § 300aa-12(e)(2)(A)-(C).
Findings of fact and discretionary rulings are reviewed under an “arbitrary and capricious”
standard, while legal conclusions are reviewed de novo. Munn v. Sec’y of Health & Human
Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992).
This Court cannot “substitute its judgment for that of the special master merely because it
might have reached a different conclusion.” Snyder ex rel. Snyder v. Sec’y of Dep’t of Health &
15
Dr. Tornatore is a board-certified neurologist. See Ex. 27, dated Nov. 24, 2015 (“Tornatore
CV”). He graduated from Cornell University with a Bachelor of Arts in Neurobiology, and then
attended Georgetown University Medical center where he received a Master of Science in
Physiology. See Tornatore CV at 2; Tr. at 98. He subsequently graduated from medical school at
Georgetown University School of Medicine, completed a residency in the Department of
Neurology at Georgetown University Hospital, and completed a fellowship in molecular virology
at the National Institutes of Health in Bethesda, Maryland. See id. Currently, he serves as Vice
Chairman in the Department of Neurology at MedStar Georgetown University Hospital and as a
Professor of Neurology at Georgetown University Medical Center. See Tornatore CV at 3; Tr. at
98-99.
16
Dr. Leist attended the University of Zurich, where he obtained his Ph.D. in immunology
and biochemistry as well as a post-doctorate degree in experimental pathologies. See Tr. at 188-
89; see also Ex. B (“Leist CV”). He also completed a post-doctorate at the University of
California, Los Angeles and attended medical school at the University of Miami. See id. He then
completed a residency in neurology at Cornell University before becoming a fellow at the National
Institutes of Health. See Tr. at 189. Dr. Leist is board certified in neurology and currently serves
as a professor of neurology at Thomas Jefferson University in Philadelphia, Pennsylvania as well
as directing the MS center and guiding the MS or the neuro-immunology fellowship program. See
id.
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Human Servs., 88 Fed. Cl. 706, 718 (2009). “Reversal is appropriate only when the special
master’s decision is arbitrary, capricious, an abuse of discretion, or not in accordance with the
law.” Id. Under this standard, a special master’s decision “must articulate a rational connection
between the facts found and the choice made.” Cucuras v. Sec’y of Dep’t of Health & Human
Servs., 26 Cl. Ct. 537, 541–42 (1992), aff’d, 993 F.2d 1525 (Fed. Cir. 1993) (citing Burlington
Truck Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)). This standard is “highly
deferential.” Hines v. Sec’y of Dep’t of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir.
1991). “If the special master has considered the relevant evidence of record, drawn plausible
inferences and articulated a rational basis for the decision, reversible error will be extremely
difficult to demonstrate.” Id.
III. DISCUSSION
Althen v. Secretary of Health & Human Services provides the evidentiary burden for
petitioners attempting to succeed in a vaccine petition based on causation. See generally Althen
v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). In order to prove causation-
in-fact, a petitioner must
show by preponderant evidence that the vaccination brought about [petitioner’s]
injury by providing: (1) a medical theory causally connecting the vaccination and
the injury; (2) a logical sequence of cause and effect showing that the vaccination
was the reason for the injury; and (3) a showing of a proximate temporal
relationship between vaccination and injury.
Id. at 1278. In order to succeed, petitioners must provide a “reputable medical or scientific
explanation” for their claim. Id.
Within this framework, petitioner makes two numbered objections to the October 18,
2017 decision. See MFR at 10, 26. First, petitioner asserts that the Special Master’s decision to
discount the fact testimony in its entirety was arbitrary, capricious, and an abuse of discretion.
Id. at 10. Second, petitioner argues that the Special Master committed error in his Althen prong
two analysis by failing to consider relevant evidence and requiring evidence that does not exist.
Id. at 26.
A. Fact Testimony
In his Motion for Review, petitioner alleges that the Special Master’s decision to discount
the fact testimony in its entirety was arbitrary, capricious, and an abuse of discretion. MFR at
10. In making this argument, petitioner posits that the Special Master failed to address the La
Londe factors. MFR at 16. Petitioner further argues that the Special Master “did not clearly
explain his basis for affording no weight to [the] credible [fact witness] testimony.” Id. at 18.
At the outset, the Special Master is not bound to follow the analytical framework
articulated by this Court in La Londe. A decision of this Court only binds a special master in the
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same case on remand. Hanlon ex rel. Hanlon v. Sec’y of Dep’t of Health & Human Servs., 40
Fed. Cl. 625, 630 (1998), aff’d, 191 F.3d 1344 (Fed.Cir.1999)); Jones v. Sec’y of Dep’t of Health
& Human Servs., 78 Fed. Cl. 403 (2007); Snyder ex rel. Snyder, 88 Fed. Cl. at 719, n.23.
Further, petitioner is incorrect in asserting that Special Master Corcoran failed to discuss
the La Londe factors. The Special Master specifically cited to La Londe, stating the following:
In determining the accuracy and completeness of medical records, the Court of
Federal Claims has listed four possible explanations for inconsistencies between
contemporaneously created medical records and later testimony: (1) a person’s
failure to recount to the medical professional everything that happened during the
relevant time period; (2) the medical professional’s failure to document everything
reported to her or him; (3) a person’s faulty recollection of the events when
presenting testimony; or (4) a person’s purposeful recounting of symptoms that did
not exist.
Dec. at 15; La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d,
746 F.3d 1334 (Fed. Cir. 2014). The Special Master then goes on to state that “[i]n making a
determination regarding whether to afford greater weight to contemporaneous medical records or
other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination.” Dec. at 15 (citing Burns v. Sec’y of Health & Human Servs.,
3 F.3d 415, 417 (Fed. Cir. 1993)).
Special Master Corcoran ultimately determined that, while the fact witnesses were
credible individuals, “the instances they described are too anecdotal and inconclusive to deem
significant (especially without any additional corroborative proof),” particularly where “their
oral recollections are compared with Petitioner’s more precisely-documented, medically-tested
symptoms referenced in the January and February 2013 medical records.” Dec. at 18. The
Special Master expanded on this by stating that the fact witness testimony “was not sufficiently
corroborated by other circumstantial evidence to elevate it over contemporaneous record proof
that clearly establishes a later onset date.” Id. However, he did determine that there exists an
overlap between the contentions of the fact witnesses and the information in the medial records
in December 2012, thereby determining that the “ADEM-related symptoms began no earlier than
late December 2012. . . , as confirmed by witness testimony and corroborated by medical records
from around the time Petitioner first sought treatment for his gait problems in January 2013.” Id.
Petitioner specifically points to a journal entry dated March 9, 2013, in which petitioner’s
wife states that Mr. Caruso began having neurological symptoms in November 2012. MFR at
21-22. Petitioner takes issue with the fact that the Special Master did not afford this journal
entry more weight than he afforded to the contemporaneous medical records, which support a
late-December or early-January onset. MFR at 22; Dec. at 18, n.18. While petitioner might
prefer more weight be afforded to Mrs. Caruso’s March 9, 2013 journal entry, the Special Master
clearly evaluated its relevance in establishing an onset period.
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Determining what weight should be afforded to the testimony of a fact witness, expert
witness, or medical records is a finding well within the discretion of the Special Master, and this
Court will not endeavor to infringe upon that well-established discretion.
B. Althen Prong Two
In addition to arguing that the Special Master’s treatment of the fact testimony was
arbitrary, capricious, and an abuse of discretion, petitioner also asserts that the Special Master
erred as a matter of law by failing to consider relevant evidence and requiring evidence that does
not exist in his analysis of Althen prong two. Specifically, petitioner alleges that the Special
Master “failed to consider relevant evidence in determining whether the petitioner met his
burden of establishing a logical sequence of cause and effect between the vaccination and the
injury,” and that “in doing so the Special Master’s conclusion amounted to his own speculation
and, thus, was arbitrary, capricious, and an abuse of discretion.” MFR at 26-27. Petitioner also
asserts that, contrary to law, the Special Master “elevated petitioner’s burden of proof by
requiring medical literature specifically describing [Mr. Caruso’s] clinical picture—and not
ADEM generally—occurring as a result of vaccination.” Id. at 27.
As an initial matter, Althen prong two requires “a logical sequence of cause and effect
showing that the vaccination was the reason for the injury.” Capizzano v. Sec’y of Health &
Human Servs., 440 F.3d 1317, 1324 (Fed. Cir. 2006) (quoting Althen, 418 F.3d at 1278). “‘A
logical sequence of cause and effect’ means what it sounds like—the claimant’s theory of cause
and effect must be logical.” Id. at 1326. While a finding of causation “must be supported by a
sound and reliable medical or scientific explanation,” causation “can be found in vaccine
cases. . .without detailed medical and scientific exposition on the biological mechanisms.”
Knudsen v. Sec’y of the Dep't of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994).
However, petitioners must still provide a “reputable medical or scientific explanation” for their
claim. Althen, 418 F.3d. at 1278.
The Special Master acknowledged that “preponderant evidence better supports the
ADEM diagnosis,” and that “there is ample record evidence supporting the diagnosis of ADEM
over other central nervous system demyelinating diseases like MS (i.e. nature of lesions, lack of
oligoclonal bands), and the lack of recurrent or new lesions later further supports ADEM.” Dec.
at 19. However, the Special Master also found that “the most reliable evidence concerning
Petitioner’s diagnosis is not supportive of the causation theory he has (successfully) presented.”
Id. at 20 (emphasis in original). The Special Master expanded on this in the following way:
Mr. Caruso’s combination of symptoms, imaging evidence, and other test results
led skilled treaters to adopt ADEM as the proper diagnosis, and I find sufficient
preponderant evidence supports that conclusion (especially in light of Dr.
Dorfman’s views expressed in the summer of 2014, which had the benefit of a more
expansive record to review than what had been available to initial treaters). But
because Petitioner’s symptoms were inconsistent with ADEM as it is most
commonly understood, it becomes more difficult to simply assume that the same
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vaccine association applicable to “normal” cases of the disease applies here. Indeed,
the literature offered to explain a vaccine’s role in causing ADEM largely if not
exclusively discusses the acute form of the disease, beginning within a month of
infection or vaccination – not what the facts show Mr. Caruso experienced.
Id.; S. Tenembaum, et al., Acute Disseminated Encephalomyelitis: A Long Term Follow-Up
Study of 84 Pediatric Patients, 59 Neurology 8: 1224-31, at 1224 (2002), filed as Ex. 26C (ECF
No. 25-1); F. Noorbakhsh, et al., Acute Disseminated Encephalomyelitis: Clinical and
Pathogenesis Features, 29 Neurologic Clinics 759-780, at 761 (2008), filed as Ex. 26B (ECF
No. 25-1).
As the Special Master noted, “the symptoms of ADEM appear abruptly—that is, between
one and two week[s] after the triggering event—in the overwhelming majority of cases.” Dec. at
20 (citing Stillwell v. Sec’y of Health & Human Servs., No. 11-77V, 2013 WL 4540013, at *16
(Fed. Cl. Spec. Mstr. June 17, 2013), mot. for review den’d, 118 Fed. Cl. 47 (2014)). The
Special Master also noted that “[n]ot only was Petitioner outside the usual demographic group
experiencing the disease (the very young), but his symptoms did not manifest acutely or
suddenly, but instead unfolded more slowly and haltingly.” Id. Then, the Special Master
pointed out that even “had I accepted Petitioner’s allegation that onset of ADEM occurred in
November (and thus closer in time to vaccination), the progression of his symptoms would
appear even less like classic ADEM, since his medical history would then constitute a series of
somewhat mild neurologic symptoms (some weakness, vision difficulty), later leading to more
concerning gait dysfunction that slightly improved before progressively worsening a month
later.” Finally, the Special Master concluded that “[p]etitioner has not demonstrated that reliable
science linking vaccines like the flu vaccine to ADEM applies to his own circumstances, which
present a more halting form of the condition.” Id. at 21.
Traditionally, “Special Masters have broad authority in building a record for decision in
vaccine cases and enjoy ‘flexible and informal standards of admissibility of evidence.’” Hunt v.
Sec’y of Health & Human Servs., 123 Fed. Cl. 509, 519 (2015) (citing Davis v. Sec'y of Health &
Human Servs., 94 Fed. Cl. 53, 65 (2010), aff'd in part, rev'd on other grounds, 420 F. App’x. 973
(Fed. Cir. 2011) (quoting 42 U.S.C. § 300aa–12(d)(2)(B))). Special Masters need not discuss
every scintilla of evidence when issuing a decision. As such, “[t]his Court will not substitute its
judgment for that of the Special Master when the Special Master considered all of the pertinent
evidence, including many of the particulars cited by Petitioner.” Vaughan on Behalf of A.H. v.
United States, 107 Fed. Cl. 212, 220 (2012). While it is clear that petitioner takes issue with the
way that the Special Master weighed the evidence presented to him, Special Master Corcoran
clearly considered all of the pertinent evidence provided. This Court cannot reweigh the
evidence at hand to arrive at a new conclusion without infringing upon the great deference
afforded special masters in making compensation decisions.
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III. CONCLUSION
This Court finds that petitioner has not met his burden of proof in alleging that his
October 16, 2012 influenza vaccine resulted in his acute disseminated encephalomyelitis. For
the foregoing reasons, the Court DENIES petitioner’s Motion for Review.17
IT IS SO ORDERED.
s/ Loren A. Smith
Loren A. Smith,
Senior Judge
17
This opinion shall be unsealed, as issued, after April 2, 2018 unless the parties, pursuant to
Vaccine Rule 18(b), identify protected and/or privileged materials subject to redaction prior to that
date. Said materials shall be identified with specificity, both in terms of the language to be redacted
and the reasons therefor.
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