Court Opinion

ID: 3188942
Source: CourtListenerOpinion
Date Created: 2016-03-25 16:02:00.634247+00
Date Added: 2024-06-11T14:35:33.327198
License: Public Domain

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

* * * * * * * * * * * * * *
DREYTON JAKES,             *
                           *                          No. 06-831V
               Petitioner, *
                           *                          Special Master Hamilton-Fieldman
v.                         *
                           *                          Exclusion of evidence; onset
SECRETARY OF HEALTH        *                          determination.
AND HUMAN SERVICES,        *
                           *
               Respondent. *
* * * * * * * * * * * * * *

ORDER DENYING MOTION TO EXCLUDE AND FINDING OF FACT CONCERNING
                     ONSET OF SYMPTOMS 1

        On December 7, 2006, Carol Jakes filed a petition on behalf of her minor son, Dreyton
Jakes (“Petitioner”), 2 pursuant to the National Vaccine Injury Compensation Program. 3 Ms.
Jakes, who was pro se, alleged that Dreyton received an influenza (“flu”) vaccination on

       1
          Because this published order contains a reasoned explanation for the undersigned’s
action in this case, the undersigned intends to post this order on the United States Court of
Federal Claims’ website, in accordance with the E-Government Act of 2002, (codified as
amended at 44 U.S.C. § 3501 note (2012)). As provided by Vaccine Rule 18(b), each party has
14 days within which to request redaction “of any information furnished by that party: (1) that is
a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that
includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the entire order will be
available to the public. Id.

           2
          Petitioner was a minor at the time of the filing, and his mother filed the action on his
 behalf. Once he reached the age of majority, the caption was amended to name Dreyton Jakes
 as the petitioner. See Order, filed June 18, 2015.
       3
          The National Vaccine Injury Compensation Program is set forth in 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.A. ' 300aa-10-' 300aa-34 (2012) (“Vaccine Act” or the “Act”). All
citations in this decision to individual sections of the Vaccine Act are to 42 U.S.C.A. ' 300aa.
                                                  1
December 12, 2003, and that the flu vaccination caused him to suffer from neurological injuries.
The case is presently before the undersigned on Petitioner’s Motion to Exclude Portions of
Medical Records (“Pet. Mtn.”), filed October 14, 2015, and for resolution of the underlying
factual dispute concerning onset of the symptoms of Petitioner’s alleged vaccine injury.

       A detailed procedural history of the case was set forth by the undersigned in an Order to
Show Cause filed June 4, 2015. The portions of that history relevant to the present dispute
concerning reliability of medical records and onset of symptoms are repeated herein to provide
context for the present findings and orders:

         During a status conference conducted on August 12, 2013 by Special Master Zane (who
previously presided over this matter), Petitioner’s counsel, Mr. Fialkow, advised that Petitioner
“was not prepared to proceed to hearing with her current expert.” See Order, dated August 13,
2013, at 1. Mr. Fialkow “advised that[,] based upon review of[,] and upon discussions with[,]
her expert regarding Respondent’s expert’s opinion [regarding] the temporal relationship
between the receipt of the vaccination and the onset of injury, [an injury onset of] less than 24
hours was too short to have been due to autoimmune response.” Id. Mr. Fialkow instead wished
to proceed by exploring other potential theories of neurotoxicity or allergic response. Id.
Special Master Zane granted Petitioner additional time to explore a new theory and directed her
to file a supplemental expert report by no later than November 29, 2013. Id. at 1-2. Mr. Fialkow
made and withdrew a request to depose Respondent’s expert; Special Master Zane explained that
such depositions are unusual in the Vaccine Program, and that Mr. Fialkow’s request was
premature. Id.

        This case was subsequently reassigned to the undersigned. See Order Reassigning Case,
dated September 4, 2013. Petitioner failed to file a supplemental expert report by November 29,
2013, and filed nothing further until January 10, 2014, when the undersigned issued an Order to
Show Cause why the case should not be dismissed for failure to prosecute. Petitioner’s response
to the Show Cause Order was due no later than February 7, 2014. See Order, filed January 10,
2014, at 1. Petitioner ultimately filed a timely request for, and was granted, an extension to file
her expert report, see Petitioner’s Status Report, filed January 22, 2014, and Non-PDF Order,
filed January 23, 2014, which was ultimately filed on March 19, 2014. See Pet. Ex. A, filed
January 23, 2014. Petitioner’s new expert, Dr. Evgeny Tsimerinov, opined that “the Influenza
vaccination triggered a molecular response of not only against the [sic] Influenza vaccine antigen
but also against the native brain and spinal cord myelin antigen, which led to the patient’s
neurological symptoms.” Id. at 5. Dr. Tsimerinov appears to have believed that D.J.’s vaccine-
caused injury was acute disseminated encephalomyelitis (“ADEM”). Id. at 3.

       Respondent filed a second expert report, authored by Dr. Sriram, on June 17, 2014. See
Resp. Ex. C. Dr. Sriram again opined that D.J. had pre-clinical MS at the time of vaccination,

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not ADEM, and that it was not biologically plausible for the vaccine to have aggravated his
condition. Id. at 3-4.

        During a status conference conducted on July 23, 2014, Mr. Fialkow renewed his
previous request to depose Respondent’s expert. Noting that discovery generally is not permitted
in the Vaccine Program, the undersigned denied Mr. Fialkow’s request, but granted him the
opportunity to follow up with a written motion. See Order, filed July 24, 2014, at 1-2. The
undersigned also directed Petitioner to file, by no later than August 20, 2014, a status report
containing a deadline for the filing of his supplemental expert report (or proposing an alternative
schedule). Id. The undersigned granted Petitioner until August 6, 2014, to file a discovery
motion, but no such motion was ever filed. Id.

       Petitioner subsequently requested and was granted an opportunity to file a second
amended petition. See Petitioner’s Motion, filed August 8, 2014; Non-PDF Order, filed August
12, 2014. Petitioner’s new petition alleged that the onset of D.J.’s injury had occurred as of
December 15, 2003, three days post-vaccination, when D.J.’s teacher reported to his parents “a
decrease in visual acuity in that [D.J.] seemed to be having a hard time seeing the board.”
Second Amended Petition, filed August 18, 2014, at 1.

        Another status conference took place on August 19, 2014, during which the undersigned
directed Respondent to file a status report documenting whether she agreed with Petitioner that
the onset of D.J.’s injury onset took place within 48-52 hours of vaccination. See Non-PDF
Order, filed August 19, 2014. Respondent took the position that, in light of the contemporaneous
medical records, the onset of D.J.’s injury had occurred on December 12, 2003, the same day as
the vaccination. See Status Report, filed October 3, 2014, at 2-3. Respondent argued that the
undersigned could make such a finding without holding a fact hearing. Id.

         The undersigned conducted a third status conference on October 21, 2014. See Order,
dated October 23, 2014, at 1. The undersigned agreed with Respondent’s assessment of the
onset date, but granted Mr. Fialkow the opportunity to conduct further investigation into the date
of onset. Id. In order to prove that D.J.’s symptoms began on December 15th, not December
12th, Mr. Fialkow wished to obtain D.J.’s school attendance records and to interview the teacher
who purportedly observed D.J.’s symptoms on the relevant date(s). Id. The undersigned granted
Mr. Fialkow additional time to locate the teacher and the records, but ordered that, in the event
that he was able to locate the teacher, he not speak with her. Id. Instead, a fact hearing would be
held so that the undersigned could observe the teacher’s demeanor when questioned about her
ability to recall events from 11 years earlier, including D.J.’s symptoms. Id. The undersigned
ordered Mr. Fialkow to file a status report regarding the progress of his investigation by no later
than December 16, 2014. Id.

                                                 3
       On December 16, 2014, Mr. Fialkow filed a status report in which he requested
additional time to locate the teacher, whom he had recently been able to identify. The
undersigned granted this request and directed Mr. Fialkow to file another status report by
February 17, 2014. See Order, filed December 17, 2014, at 1. On February 24, 2015, Mr.
Fialkow reported that, although he had the teacher’s name, he had yet to locate her. See Status
Report, filed February 24, 2015, at 1-2. Mr. Fialkow made no mention of school attendance
records. Id. He reiterated his request that the undersigned revisit prior rulings. Id.

        The undersigned conducted another status conference on April 7, 2015, during which the
parties agreed to collaboratively compose a letter to D.J.’s teacher regarding her memory of the
events at issue. See Order, filed April 8, 2015, at 1. Mr. Fialkow indicated that he had had
difficulty obtaining D.J.’s school attendance records, and the undersigned suggested that he
request subpoena authority. Id. The undersigned also directed Mr. Fialkow to file declarations
from any other relevant fact witnesses. Id.

        Since that time, the undersigned has convened a number of status conferences. Petitioner
has filed several hundred pages of records obtained pursuant to a subpoena served on Petitioner’s
elementary school. See Petitioner’s Exhibit (“Pet. Ex.”) 29. He has also filed a letter from Ms.
Julie Bogetti, which was the result of Petitioner’s attempts to locate the first grade teacher who
contacted his mother during the disputed time period concerning Petitioner’s loss of vision and
inability to see the board. See Pet. Ex. 30. Ms. Bogetti’s letter stated that she had not been
Petitioner’s teacher. Id.

       Petitioner’s Motion to Exclude included a “Memorandum of Points and Authorities”
paginated consecutively with the Motion. Petitioner also filed the Declaration of Carol Jakes, his
mother (“Decl. Carol Jakes”) and the Declaration of Andre Jakes, his father (“Decl. Andre
Jakes”) on October 14, 2015. Respondent’s Response to the Motion was filed November 13,
2013 (“Resp. Response”); Petitioner’s Reply was filed November 19, 2015 (“Pet. Reply”).

MOTION TO EXCLUDE

       In his Motion, Petitioner seeks to exclude

       any and all evidence, references to evidence, testimony or argument relating to
       the following portions of the medical records originally filed by Petitioner
       which inaccurately and incompletely refer to the onset of DJ's medical
       condition, namely: (a) at page 762 "mother has noticed at home past couple of
       days sitting too close to television unable to see" and "three days ago"; (2) at
       page 770 "Initial consult states onset of visual loss is uncertain. First noticed
       by teacher on December 12, 2003, the same day he received his influenza
       vaccine" and "on Sunday afternoon he complained about being tired and that

                                                4
       his leg hurt and his mother asked why he was sitting close to the T.V., then
       reported that he had told he had trouble seeing the T.V. and then Sunday went
       to sleep"; (3) at page 789 "His teacher noted decreased vision on Friday and
       moved closer to the board"; and (4) at 856 "the patient's teacher noted the
       patient having difficulties with vision on Friday, 12/12/2003. Over the
       weekend, the patient's family also noted the patient having increasing trouble
       seeing, complaining of inability to see the clock or the television.”

Pet. Mtn. at 1.

        Petitioner’s first argument in favor of exclusion is that the records he seeks to exclude are
hearsay, or hearsay within hearsay, citing Federal Rules of Evidence (“Rules”) 801(a), 802, and
805. Mtn. at 3-4. He asserts that the records are “inaccurate and incomplete” and should
therefore be excluded in favor of later medical records which are supported by the affidavits of
his parents filed with his Motion. Pet. Mtn. at 3.

        The Federal Rules of Evidence do not apply in Vaccine Program cases. See RCFC App.
B, Rule 8 (b)(1) (“In receiving evidence, the special master will not be bound by common law or
statutory rules of evidence but must consider all relevant and reliable evidence governed by
principles of fundamental fairness to both parties.”); see also 42 U.S.C. §300aa-
12(d)(2)(B)(standards applicable to admissibility of evidence in Vaccine Act cases are to be
“flexible and informal”). Even assuming for sake of argument that the Federal Rules of Evidence
applied in Vaccine Program cases, Rule 803(4) provides an exception to the hearsay rule,
regardless of the availability of the declarant, for “Statement[s] Made for Medical Diagnosis or
Treatment,” including statements “made for – and reasonably pertinent to – medical diagnosis or
treatment,” and statements that “describe[] medical history; past or present symptoms or
sensations; their inception; or their general cause.” This exception was adopted “in view of the
patient’s strong motivation to be truthful,” Rule 803, advisory committee’s note to 1972
proposed rules of evidence, and clearly encompasses the records at issue here. Thus, the
evidence Petitioner seeks to exclude is admissible under the Federal Rules of Evidence, and
should not be excluded on that basis.

         Under the rules governing cases brought pursuant to the Vaccine Act, the same
standards concerning reliability of medical records created contemporaneously with the illness
or injury they address apply. In Cucuras v. Secretary of Health and Human Services, 933 F.2d
1525, 1528 (Fed. Cir. 1993), the Federal Circuit found this category of evidence reliable,
explaining that medical records "contain information supplied to or by health professionals to
facilitate diagnosis and treatment of medical conditions …. [w]ith proper treatment hanging in
the balance, accuracy has an extra premium.”

                                                  5
        Petitioner asserts that the records he seeks to exclude are inaccurate and incomplete
because, in essence, his mother says they are. See, e.g., Pet. Mtn. at 3 quoting Decl. Carol
Jakes at 4 (“[Ms. Jakes] never told anybody that Dreyton’s [sic] had any visual problems that
started on Friday or that he had any problems on Friday, because he didn’t …. [Ms. Jakes]
looked at the medical records and they are not very precise and at times they are inaccurate.”).
While this argument can certainly be considered in determining what weight to give to these
records vis-à-vis the remaining medical records, it provides absolutely no legal basis for
excluding the records from consideration at all.

          Finally, Petitioner’s Motion to Exclude Records does not comport with either the
 letter or the spirit of the Vaccine Act, which requires that complete medical records be filed
 with the petition, 42 U.S.C. §300aa-11(c)(2), requires the special master to consider the
 record as a whole, 42 U.S.C. §300aa-13(a)(1), and mandates “flexible and informal
 standards of admissibility of evidence.” 42 U.S.C. §300aa-12(d)(2)(B).

         For the reasons set forth above, Petitioner’s Motion to Exclude Records is DENIED.

FINDING OF FACT CONCERNING ONSET

         Turning now to the underlying issue of onset, the issue as framed by the parties is
 this:

          Did Petitioner develop symptoms of his alleged vaccine-caused neurological injuries,
 specifically, problems with his eyesight, within 24 hours or less of receiving the vaccine, i.e.,
 December 12, 2003, or did those problems only begin to develop Sunday night, December
 14, 2003, approximately 48 to 52 hours after vaccination? Petitioner argues in favor of the
 latter, later onset, Petitioner’s Motion to Exclude and Memorandum of Points and
 Authorities; Respondent in favor of the former, earlier onset. See Respondent’s Status
 Report concerning onset filed October 3, 2014.

         There is no dispute that Petitioner received a flu vaccine on December 12, 2003.
 There is also no dispute that the medical records from Monday, December 15 and Tuesday,
 December 16, 2003, when Petitioner first presented to medical professionals with vision
 problems, state that the problems began on Friday, December 12, 2003. These are the
 records that Petitioner seeks to exclude, excerpts of which are set forth at some length below.
 Petitioner disputes the accuracy and completeness of those medical records, and asserts that
 in making her factual determination concerning onset, the undersigned should rely instead on
 medical records created approximately 90 days after onset, beginning March 17 and March
 20, 2004, and on the affidavits of Petitioner’s parents filed in conjunction with his Motion.

                                                 6
         The undersigned agrees with Petitioner that the Cucuras presumption in favor of the
 accuracy and reliability of medical records prepared contemporaneously with the events
 being described in those records is a rebuttable one. 993 F.2d 1525, 1528 (Fed. Cir. 1993);
 see also Camery v. Sec'y of Health & Human Servs., 42 Fed. Cl. 381, 391 (1998) (the rule
 set forth in Cucuras "should not be applied inflexibly, because medical records may be
 incomplete or inaccurate"); Pet. Mtn. at 4. The undersigned has, for example, found that
 a vaccine was administered even in the absence of a contemporaneous record
 documenting the vaccination. See Figueroa v. Sec’y of Health & Human Servs., No. 10-
 750V, 2014 WL 6819494, at *4 (Fed. Cl. Spec. Mstr. Nov. 7, 2014). In the present case,
 however, there is not just one missing or anomalous record. There are at least four
 different records, from at least four different medical professionals, from at least two
 different medical facilities (Kaiser Stockton and Dameron Hospital), setting forth the
 history of onset beginning December 12, 2003, in different yet consistent terms. The
 relevant passages from those records are as follows:

               Pet. Ex. 4 at 762, Kaiser Permanente Manetca Nursing Record,
       dated “12/15/03”: “progressive visual decline. Teacher called mother
       today [and] told her the vision has deteriorated so much that he is unable
       to participate in class. Here today. Child is c/o unable to see board.
       Mother has noticed @ home past couple days, sitting too close to
       television c/o unable to see. Appt w/ DR. Estrada today @ 3:30 pm”

               Pet. Ex. at 762, Kaiser Permanente Manetca Nursing Record,
       dated “12/15/03”, immediately below the preceding passage, but in
       different handwriting: “Attending Note: S: [circled] c/o last night
       couldn’t see TV. ‘Can’t see.’ Difficulty dressing. Teacher called Mom
       telling Pt. couldn’t see board to participate. 3 days ago, couldn’t see
       board. No hst of vision problem.”

             Pet. Ex. at 789, Smart Tool – Ophthalmology – Stockton, dated
       “12-15-03”: “Pt’s teacher noted ↓ VA on Friday. Moved closer to board.
       Today, seemed even worse. Mom states he also couldn’t see TV this
       weekend. Both eyes affected. C/o being tired lately, ØHA, ØN/V.”

             Pet. Ex. at 789, Smart Tool – Ophthalmology – Stockton, dated
       “12-15-03”, further down the page from the preceding passage, possibly

       4
        On December 1, 2009, Petitioner filed 961 pages of medical records, none of which
were labeled with exhibit numbers. These records were filed on paper only, and have not been
uploaded to the electronic record. The undersigned will refer to these medical records by page
number only, e.g., “Pet. Ex. at 1.”
                                               7
       another different scribe: “Mom states pts 12 yo brother also c̅ ↓VA →
       advised she bring him tomorrow also. Has been excessively sleepy last
       week & over weekend → sleeps right after school. Yesterday was ok,
       slept at [illegible] times. Ø unusual behavior, listlessness, speech
       problems, HA or N/V.”

               Pet. Ex. 29 at 398, Dameron Hospital Association Progress
       Record, dated “12-16-03” at “3:30 p.m.”, under a heading that states
       “HOSPITAL REGULATION: All Positive and Important Negative
       Findings Shall Be Recorded”: “6 yo ♂ c̅ Loss of vision ON – onset not
       certain teacher noted on Friday 12/12/03 that pt had trouble seeing board.
       Symptoms worsened on Friday. Seen in Manteca 12/15 c̅ ↓VA noted
       ON. Seen by opth [illegible] on 12/15 & 12/16. Pt c̅ ↓VA to CF ON.
       Swollen optic nerve head OD, ON pallor c̅ retrobulbar swelling on CT
       scan os. Mother denies other current c/of x̅ leg pain”

               Pet. Ex. at 856, typed, History and Physical, Dameron Hospital,
       Stockton, California, dated “12/16/2003”, also date stamped “DEC 16
       PM”: 5 “The patient is a 6 year old African-American male with a history
       of loss of vision in both eyes. The date of onset is not [“100%” is crossed
       out and “entirely” is handwritten beside it] certain, however, the patient’s
       teacher noted the patient having difficulties with vision on Friday,
       12/12/2003. Over the weekend, the patient’s family also noted the patient
       having increasing trouble seeing, complaining of inability to see the clock
       or the television.

              ...

              The history also is significant in that the patient received the flu
       shot on Friday. He has not had a change in mental status, although the
       mom states that earlier in the week, he seemed excessively sleepy and
       was going to sleep immediately after school and sleeping through the
       night. However, as of Sunday, he had been sleeping a normal amount and
       had resumed his normal activities.

       5
         This may be a typed version of the passage from Pet. Ex. 29 p. 398, as some of the
language is very similar, although as Petitioner notes some of the language also appears to
be taken from Pet. Ex. at 789 (see Decl. Carol Jakes ¶20), so it could be a combination of
the two records, combined for purposes of dictation.
                                              8
              Over the last two days, he has also developed some leg pain, the
       etiology of which is unclear.”

        The first record that provides a history of onset different than that set forth above is a
typewritten record dated and date stamped March 17, 2004, from the office of Richard L.
Friederich, M.D. Pet. Ex. at 770-71. This record provides a very detailed history in which the
scribe notes parenthetically that “Mother is giving the story in very great detail, much more
detail than reported here, and very rapidly.” Id. at 771. This is the first record that places “onset
approximately 3 days after receiving influenze [sic] immunization.” Id. at 770. The
discrepancies in the histories are noted: “Initial consult states onset of visual loss is uncertain,
first noticed by teacher on 12Dec03, the same day he received his influenza vaccine, vision loss
subsequently confirmed by parents over the next couple days. . . .Other reports state he awoke
with abruptly decreased vision.” Id. The record from Dr. K. M. Saba relates a history of
“sudden, painless bilateral vision loss on December 15, 2003,” Pet. Ex. at 315, and a nurse’s
admission record from the Kaiser Foundation Hospital, Dr. Siciliano, dated “3/23/04,” notes a
medical history obtained from “Mother” and states: “Oakland Kaiser since 3/20/04. December
12, 2003, -- Blindness Ⓛ side paralysis 12/15/04 (sic) admitted to the hospital 12/20/03.” Pet.
Ex. at 219. Thereafter, there are no further references to a December 12, 2003 onset.

       The undersigned understands that Ms. Jakes remembers talking with more than one
person when she and Dreyton arrived at Kaiser. Dec. Carol Jakes at 4. The undersigned also has
no doubt that Ms. Jakes’ recollection is that she did not tell anyone that Dreyton had visual
problems starting on Friday December 12. Id.

         The accounts set forth in the medical records from December 15 and 16, 2003, are
different in a number of ways, but as to their description of the date of onset, they are essentially
consistent. They were recorded by several different medical professionals, at different medical
facilities, in several different formats. Based on the undersigned’s extensive experience
reviewing medical records, it is simply not plausible that that many different people at different
times in different contexts while performing one of the essential functions of the medical
profession (taking/recording history and symptoms) could have made the same basic, and
potentially critical, mistake. Based on the foregoing analysis and a review of the record as a
whole, the undersigned FINDS that the date of onset of Petitioner’s vision problems was
December 12, 2003.

                                                  ORDER

       This case is now ten years old. Petitioner has been afforded abundant opportunity to
present his case; the undersigned will brook no further delays. No later than 63 days from the
date of this Order, by April 29, 2016, Petitioner shall file an expert report that includes a

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causation theory consistent with the onset ruling set forth herein. Failure to file such an
expert report will result in dismissal of Petitioner’s vaccine claim.

       IT IS SO ORDERED.

                                           s/ Lisa Hamilton-Fieldman
                                           Lisa Hamilton-Fieldman
                                           Special Master

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