Court Opinion

ID: 2824838
Source: CourtListenerOpinion
Date Created: 2015-08-11 05:28:51.032173+00
Date Added: 2024-06-11T12:34:15.875376
License: Public Domain

In the United States Court of Federal Claims
                                  OFFICE OF SPECIAL MASTERS

* * * * * * * * * * * * * * * * * * * * **
STACY BOULA and                          *
WILLIAM BOULA,                           *   No. 13-356V
legal representatives of an infant,      *
STEPHANIE BOULA,                         *   Special Master Christian J. Moran
                                         *
                    Petitioners,         *   Filed: July 17, 2014
                                         *
v.                                       *   Findings of fact; onset;
                                         *   connective tissue disorder
SECRETARY OF HEALTH                      *
AND HUMAN SERVICES,                      *
                                         *
                    Respondent.          *
* * * * * * * * * * * * * * * * * * * * **
Gary C. Hobbs, Muller, Mannix & Hobbs, PLLC, Glen Falls, NY, for petitioners;
Julia McInerny, United States Dep’t of Justice, Washington, DC, for respondent.

                                   FINDINGS OF FACT 1

      On May 24, 2013, Stacy and William Boula filed a petition under the
National Vaccine Injury Compensation Program (the “Vaccine Act” or
“Program”), 42 U.S.C. § 300aa-10 through 34 (2006). In their petition, the Boulas
alleged that the human papillomavirus (“HPV”) vaccine and/or hepatitis B vaccine
caused their daughter, Stephanie, to suffer an autoimmune disorder and associated
undifferentiated connective tissue disease. Pet. at ¶¶ 26, 28. The Boulas filed an
amended petition on June 5, 2013, which contained similar allegations. Am. Pet.

       1
         The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17,
2002), requires that the Court post this ruling on its website. Pursuant to Vaccine Rule 18(b), the
parties have 14 days to file a motion proposing redaction of medical information or other
information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special
master will appear in the document posted on the website.

                                                    1
at ¶¶ 28, 30.2 To support their claim for compensation, petitioners periodically
filed evidence, including medical records (exhibits 1-7, 11-13, 17, 21) and
affidavits from Mrs. Boula and Stephanie (exhibits 14, 19-20).

      The records are not consistent about the details of Stephanie’s illness. There
is uncertainty about what symptoms Stephanie experienced and when she had
them. Furthermore, during litigation, Mrs. Boula’s position changed. Compare
exhibit 14 (aff., dated May 20, 2013) (onset indicated as approximately May 20,
2010) with exhibit 20 (aff., dated Nov. 7, 2013) (onset indicated as May 24, 2010).

       When special masters are confronted with discrepancies among medical
records and affidavits, special masters are encouraged to hold a hearing to evaluate
the testimony of the affiants. See Campbell v. Sec’y of Health & Human Servs.,
69 Fed. Cl. 775, 779-80 (2006). However, petitioners declined to present oral
testimony because they believed that the written materials were sufficient to
support their contentions. Respondent did not object to a lack of hearing.
Therefore, because neither party requested a hearing, a hearing was not held. See
Vaccine Rule 8(d) (the special master may decide a case on the basis on the
record).

       In lieu of presenting testimony, the parties filed Joint Proposed Findings of
Fact. In their filing, the parties asked for findings on two points: (1) the nature of
Stephanie’s symptoms, and (2) when Stephanie’s symptoms began. Joint Proposed
Findings of Fact, filed Feb. 10, 2014, at ¶¶ 17-18 (“Proposed Findings”). The
parties anticipate how these facts will affect petitioners’ claim, reserving the right
to retain expert witnesses should the claim proceed. Id. at ¶¶ 17, 19. Following
the parties’ joint submission, petitioners were requested to obtain additional
records from Stephanie’s pediatrician, Dr. Mary Anne Kiernan. Petitioners
submitted these records on April 17, 2014 (exhibit 21), making the matter ready for
adjudication.

       2
         Petitioners also alleged that Stephanie’s injuries were “caused in fact by the [HPV]
vaccine, the MMR Vaccine, and or a component thereof.” Pet. at 1; Am. Pet. at 1. However, this
appears to be a typographical error; petitioners intended to allege that Stephanie’s condition was
caused in fact by the HPV and/or hepatitis B vaccines. See Pet. at ¶ 28; Am. Pet. at ¶ 30.

                                                    2
                               Standard for Finding Facts

        Under the Vaccine Act, petitioners are required to establish their cases by a
preponderance of the evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance
of the evidence standard requires a “trier of fact to believe that the existence of a
fact is more probable than its nonexistence before [he] may find in favor of the
party who has the burden to persuade the judge of the fact’s existence.” Moberly
v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010)
(citations omitted).

      The process for finding facts in the Vaccine Program begins with analyzing
the medical records, which are required to be filed with the petition. 42 U.S.C. §
300aa–11(c)(2). 3 Medical records that are created contemporaneously with the
events they describe are presumed to be accurate. Cucuras v. Sec’y of Health &
Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

       Not only are medical records presumed to be accurate, they are also
presumed to be complete in the sense that the medical records present all the health
problems of the patient. Completeness is presumed due to a series of propositions.
First, when people are ill, they see a medical professional. Second, when ill people
see a doctor, they report all of their health problems to the doctor. Third, having
heard about the symptoms, the doctor records what he or she was told.

       Appellate authorities have accepted the reasoning supporting a presumption
that medical records created contemporaneously with the events being described
are accurate and complete. A notable example is Cucuras in which petitioners
asserted that their daughter, Nicole, began having seizures within one day of
receiving a vaccination, although medical records created around that time
suggested that the seizures began at least one week after the vaccination. Cucuras,
993 F.2d at 1527. A judge reviewing the special master’s decision stated that “[i]n
light of [the parents’] concern for Nicole’s treatment . . . it strains reason to
conclude that petitioners would fail to accurately report the onset of their
daughter’s symptoms. It is equally unlikely that pediatric neurologists, who are
trained in taking medical histories concerning the onset of neurologically
significant symptoms, would consistently but erroneously report the onset of

       3
          With the advent of filing via CM/ECF, there should be a short delay between filing
petitions and submitting medical records. Vaccine Rule, Supplement, § 8(a)(ii).

                                                   3
seizures a week after they in fact occurred.” Cucuras v. Sec’y of Health & Human
Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d 1525 (Fed. Cir. 1993).

       However, the presumption that contemporaneously created medical records
are accurate and complete is rebuttable. For cases alleging a condition found in the
Vaccine Injury Table, special masters may find when a first symptom appeared,
despite the lack of a notation in a contemporaneous medical record. 42 U.S.C.
§ 300aa-13(b)(2). By extension, special masters may engage in similar fact-
finding for cases alleging an off-Table injury. In such cases, special masters are
expected to consider whether medical records are accurate and complete. To
overcome the presumption that written records are accurate, testimony is required
to be “consistent, clear, cogent, and compelling.” Blutstein v. Sec’y of Health &
Human Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June
30, 1998).

      In determining the accuracy and completeness of medical records, special
masters will consider various explanations for inconsistencies between
contemporaneously created medical records and later given testimony. The Court
of Federal Claims listed four such explanations. The Court noted that
inconsistencies can be explained by: (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. La Londe v. Sec’y
Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334
(Fed. Cir. 2014).

      In weighing divergent pieces of evidence, special masters usually find
contemporaneously written medical records to be more significant than later-
presented testimony. 4 Cucuras, 993 F.2d at 1528. Testimony offered after the
events in question is less reliable than contemporaneous reports when the
motivation for accurate explication of symptoms is more immediate. Reusser v.

       4
          Although the testimony in Cucuras was given orally, the relative value of testimony vis-
à-vis contemporaneously created written records does not depend on whether the witness
testified orally or in writing. See, e.g., Bast v. Sec'y of Health & Human Servs., 01-565V, 2012
WL 6858040, at *6 (Fed. Cl. Spec. Mstr. Dec. 20, 2012) (the special master found that the
doctor’s contemporaneously created medical record held more weight than the parents’ joint
affidavit), mot. for review den’d, 2014 WL 3719188 (Fed. Cl. July 8, 2014).

                                                    4
Sec’y of Health & Human Servs., 28 Fed. Cl. 516, 523 (1993). However,
compelling testimony may be more persuasive than written records. Campbell, 69
Fed. Cl. at 779 (“[L]ike any norm based upon common sense and experience, this
rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking.”); Camery v. Sec’y of Health &
Human Servs., 42 Fed. Cl. 381, 391 (1998) (this rule “should not be applied
inflexibly, because medical records may be incomplete or inaccurate”); Murphy v.
Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991) (“[T]he absence of a
reference to a condition or circumstance is much less significant than a reference
which negates the existence of the condition or circumstance”) (citation omitted),
aff’d, 968 F.2d 1226 (Fed. Cir. 1992).

                              Summary of Evidence

      The submitted evidence is summarized below in two sections: Stephanie’s
relevant medical records followed by petitioners’ three affidavits, two from Mrs.
Boula and another from Stephanie.

                                 Medical Records

       On March 11, 2010, Stephanie was seen at Long Pond Pediatrics for a well
visit. Exhibit 2 at 58. Stephanie did not present with any complaints. Id. Upon
examination, Stephanie had “normal growth and development at 15 yrs old.” Id. at
58-59. During her visit, Dr. Sarah Leddy administered Stephanie’s first HPV
vaccination. Id. at 1, 59. On May 20, 2010, Dr. Leddy administered Stephanie’s
second HPV vaccination with no associated medical exam. Id. at 1. Stephanie
received her third hepatitis B vaccination the following day, May 21, 2010, with no
record of a medical exam. Id.

       On May 24, 2010 at 3:29 P.M., Mrs. Boula called Long Pond Pediatrics and
scheduled an appointment for that same day at 4:30 P.M. Exhibit 21 at 2. During
that appointment, Stephanie reported that she had a sore throat that “started today”
and that the “onset was sudden.” Exhibit 2 at 60. Upon examination, Dr. Mary
Anne Kiernan noted that Stephanie’s tonsils were “moderately erythematous and
ulcerated.” Id. Dr. Kiernan diagnosed Stephanie with a sore throat commenting
that Stephanie probably had an “early Coxsackie infection.” Exhibit 2 at 61. Dr.
Kiernan ordered a Group A strep culture, but the strep test was normal. Id. at 61,
93. Stephanie was directed to use “Tylenol and/or Motrin as needed for pain.” Id.
at 61.

                                             5
       By May 31, 2010, Stephanie continued to complain of a sore throat, and her
mother took her to the emergency room at Rochester Memorial Hospital. Exhibit 5
at 2. Stephanie was seen by Dr. Geoffrey Everett and reported “[a] sore throat
[lasting] for 8 days, blisters to tonsils, had neg throat culture last Mon., still having
pain, unable to eat, taking fluids, blisters getting worse, no fever.” Id. at 7.
Stephanie’s reported pain level was a “6 out of 10.” Id. at 8. Upon examining
Stephanie’s ear, nose, and throat, Dr. Everett noted erythema in her posterior
pharynx, but that her tonsils were “normal in appearance.” Id. at 8. The rapid
strep throat test and the Group A strep culture test results were both normal. Id. at
3, 5. Ultimately, Dr. Everett’s impression was viral pharyngitis. Id. at 3. The
hospital discharged Stephanie with a prescription to help with her pain. Id.

       After seven intervening doctors’ visits for various problems between
September 29, 2010 and December 22, 2010 (exhibit 2 at 62-68; exhibit 4 at 1-4;
exhibit 5 at 16-26), on December 28, 2010, Stephanie went to Long Pond
Pediatrics complaining of shin pain that had lasted “since September.” Exhibit 2 at
69. Additionally, Stephanie reported stomach bloating, headaches, “ringing in
ears,” and that she was “very tired despite good sleep last night.” Id. Dr. Elizabeth
O’Brien reviewed Stephanie’s lab results, noting that “thyroid labs, cbc, and also
esr” were normal, but that “ANA came back positive last night.” Id. Upon
examination, Stephanie appeared healthy. Id. at 69-70. Dr. O’Brien suspected that
Stephanie had an autoimmune disease because she was an “otherwise healthy and
active 16 year old who now has a positive ANA.” Id. at 70; exhibit 17 at 26. Dr.
O’Brien referred Stephanie to a rheumatologist “to help with work up and possible
diagnosis.” Exhibit 2 at 70.

        On January 4, 2011, Stephanie went to see David Siegel, a pediatric
rheumatologist. Exhibit 6 at 1. Stephanie reported fatigue and multiple aches and
pains “ongoing since this spring.” Id. Dr. Siegel noted that Mrs. Boula thought
“all of Stephanie’s symptoms started after she got her [HPV] shot in March, 2010.”
Id. Also, Mrs. Boula attributed “the real start of [Stephanie’s] symptoms to having
had the second [HPV] shot (in May 2010) after which she had 3 weeks of blisters
in her throat.” Id. Dr. Siegel’s assessment found that Stephanie’s history and
exam findings “[were] not consistent with rheumatologic disease.” Id. However,
he ordered blood work to “objectively assess whether this is the case.” Id. On
January 10, 2011, the nurse practitioner called Stephanie’s father, explaining that
“all the tests were negative with the exception of the ANA, which was the same.”
Id. at 10.

                                               6
       Mrs. Boula remained concerned about Stephanie’s worsening symptoms.
See exhibit 3 at 3. Between September 9-14, 2011, she called Dr. Siegel’s office
multiple times expressing her concern. Exhibit 6 at 9. Mrs. Boula ultimately
sought another medical opinion regarding Stephanie’s condition. On September 21,
2011, Stephanie went to the Allergy, Immunology, and Rheumatology Department
at Rochester General Medical Group for “evaluation of a positive ANA.” Exhibit
7 at 1. In the history of present illness, Dr. Ana Arango noted that Stephanie had
“some symptoms suspicious for Raynaud’s,” including having “to wear gloves
inside the house.” Id. 5 Stephanie’s lab workup only yielded a high titer ANA. Dr.
Arango’s impression was that Stephanie had Raynaud’s disease and a possibility of
an inflammatory connective tissue disease. Id. at 2. He ordered several labs to
assess the possibility of an inflammatory connective tissue disease. Id.

       After seven appointments for other ailments between October 2011, and
May 2012 (exhibit 5 at 33-44; exhibit 7 at 3-4; exhibit 13 at 5-6, 10-26), on May
30, 2012, Stephanie saw Dr. Arango for a follow-up visit. Exhibit 7 at 5, 7. Dr.
Arango indicated that Stephanie had “an undifferentiated connective tissue
disease.” The Boulas allege the vaccinations in May 2010, caused Stephanie to
suffer this condition.

                                          Affidavits

      In support of their allegations, the Boulas filed two affidavits from Mrs.
Boula, dated May 20, 2013 (exhibit 14), and November 7, 2013 (exhibit 20), and
one affidavit from Stephanie Boula, dated November 7, 2013 (exhibit 19). These
affidavits are not entirely consistent with one another.

       In her first affidavit, Mrs. Boula averred that Stephanie’s sore throat started
“approximately two days after vaccination.” Exhibit 14 at ¶ 9, dated May 20,
2013. Thus, Mrs. Boula’s statement presents a problem for determining the onset
of Stephanie’s sore throat. Stephanie received two vaccinations, one each on
consecutive days. Additionally, Mrs. Boula stated that Stephanie’s sore throat
lasted for two days before she took her to Dr. Kiernan’s office. Id. The visit with
Dr. Kiernan took place on May 24, 2010. Exhibit 2 at 1.

       5
         Raynaud phenomenon is defined as “intermittent bilateral ischemia of the fingers, toes,
and sometimes ears and nose, with severe pallor and often paresthesias and pain, usually brought
on by cold or emotional stimuli and relived by heat.” Dorland’s Illustrated Medical Dictionary
1430 (32d ed. 2012).

                                                   7
      However, in her second affidavit, Mrs. Boula averred that she was “mistaken
when [she] stated in her May 20, 2013 affidavit that ‘. . . two days after being
vaccinated Stephanie began to complain of a sore throat and headache. I took
Stephanie to the doctor’s two days later when the sore throat had not resolved.’”
Exhibit 20 at ¶ 8 (aff., dated Nov. 7, 2013). She further asserted that “[her] May
20, 2013 affidavit was based on my recollection of almost 3 years earlier. I did not
have a calendar or diary of events to assist my recollection.” Id. at ¶ 9.

       Additionally, in Stephanie’s affidavit filed concurrently with Mrs. Boula’s
second affidavit, Stephanie denied experiencing any adverse reaction or symptoms
after her first HPV vaccine on March 11, 2010. Exhibit 19 at ¶ 4 (aff. dated Nov.
7, 2013). Stephanie stated that she began experiencing a sore throat on May 24,
2010, worsening throughout the day, and she had a headache. Id. at ¶ 5. Further,
Stephanie explained that the medical records from her emergency room visit on
May 31, 2010, were incorrect, and that Dr. Kiernan’s records on May 24, 2010,
accurately reflect her symptoms. Id. at ¶ 7.

                                Parties’ Positions

       Despite the discrepancies among the affidavits and medical records, the
Boulas assert that the contemporaneous records of Dr. Kiernan from May 24, 2010,
indicate that the onset of Stephanie’s first symptoms occurred on May 24, 2010.
Thus, the Boulas argue that these records are the best evidence of the date of onset
of her sore throat. Proposed Findings at ¶ 15.

       The Secretary identifies three potential dates for the onset of Stephanie’s
autoimmune disease. As evidence in support of an onset date in late March 2010,
the Secretary cited the medical records from Stephanie’s January 4, 2011 visit to
the rheumatologist, Dr. Siegel. Resp’t’s Rep’t, filed Aug. 20, 2013, at 14 (Dr.
Siegel noted that Mrs. Boula felt that Stephanie’s symptoms began two weeks after
she received the March 11, 2010 HPV vaccination). In the alternative, the
Secretary argued that if the medical record from May 31, 2010, was precisely
accurate, “eight days earlier” would place the onset of Stephanie’s symptoms on
May 23, 2010. Id. Finally, the Secretary cited Mrs. Boula’s first affidavit arguing
that the onset of Stephanie’s symptoms occurred on May 22, 2010. Id. at 14-15

                                            8
(“my daughter’s various symptoms and illnesses began within two days of being
vaccinated in May, 2010”) (citing exhibit 14 at ¶ 15, aff., dated May 20, 2013). 6

                                      Findings of Fact

                                  Nature of the Symptoms

       Although some evidence suggests that Stephanie was having problems in
March 2010, the more persuasive information indicates that she was not. In the
medical history from Stephanie’s January 4, 2011 visit, Dr. Siegel indicated that
Stephanie had fatigue and multiple aches and pains, beginning in spring 2010.
However, there are no medical records in spring 2010 to support Dr. Siegel’s
history. See generally exhibit 2. As discussed previously in the summary of the
medical records, Stephanie has an extensive medical history documenting Mrs.
Boula’s persistence in seeking medical treatment for Stephanie. Therefore, if
Stephanie were experiencing problems like fatigue, aches, and pains in late March
2010, Mrs. Boula likely would have taken her daughter to a doctor as she did in
May 2010 for a sore throat and for Stephanie’s other ailments. The absence of any
medical record from late March through April 2010, implies that Stephanie was
healthy.

       Dr. Siegel relied on Mrs. Boula’s memory to learn and to document
Stephanie’s medical history. See exhibit 6 at 1 (stating that “Mom feels,” “Mom
attributes,” and “Mom reports”). It seems likely that given events in her daughter’s
life, Mrs. Boula did remember Stephanie’s chronology accurately. Mrs. Boula
appears to have associated the onset of fatigue with the first dose of the HPV
vaccination on March 11, 2010, but actually the problems started relatively close to
the time of the second dose on May 20, 2010.7

       6
         The Secretary further argues that if the first manifestation of the autoimmune tissue
disease were in late March 2010, on May 22, 2010, or on May 23, 2010, the petition was not
filed within the statute of limitations because the petition was filed on May 24, 2013. The
Boulas should have filed their petition no later than late March 2013, May 22, 2013, or May 23,
2013. Proposed Findings at ¶ 14.
       7
         Although Mrs. Boula remembered that Stephanie developed a sore throat after an HPV
vaccination, temporal associations do not establish causation. Grant v. Sec’y of Health &
Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992).

                                                   9
       Stephanie was experiencing pain in her throat and headaches in May 2010.
Although Stephanie complained that she had “blistered tonsils” and “worsening
blisters,” neither Dr. Kiernan nor the medical staff at Rochester Memorial Hospital
indicated that Stephanie’s tonsils were blistered. In fact, the notes from the
hospital specifically state that Stephanie’s tonsils appeared “normal,” although her
posterior pharynx was erythematous.

                             When Sore Throat Began

       The medical record on May 24, 2013, carries more weight than the May 31,
2013 record. On May 24, 2013, it was easy for Stephanie to indicate whether the
sore throat began “today” or “yesterday.” Stephanie reported that her sore throat
began “today.” Exhibit 2 at 60. In contrast, on May 31, 2013, the record of
whether the sore throat began seven days or eight days or nine days prior is
probably less important to a historian or record-taker. When Stephanie spoke to
the Dr. Everett at Rochester Memorial Hospital on May 31, 2010, she could have
been estimating when she said “eight days.” Therefore, Stephanie’s symptoms
began on May 24, 2010.

                                    Conclusion

       The parties are ordered to provide these Findings of Fact to any expert
whom they may retain to offer an opinion in this case. An expert’s assumption of
any fact that is inconsistent with these Findings of Fact will not be credited. Burns
v. Sec'y of Health & Human Servs., 3 F.3d 415, 417 (Fed .Cir. 1993) (holding that
the special master did not abuse his discretion in refraining from conducting a
hearing when the petitioner’s expert “based his opinion on facts not substantiated
by the record”).

      A status conference is set for Wednesday, August 13, 2014, at 2:30 P.M.
Eastern Time. The petitioners should be prepared to discuss the next step in this
case.

      IT IS SO ORDERED.

                                                    S/Christian J. Moran
                                                    Christian J. Moran
                                                    Special Master

                                            10