Pietrucha v. Hhs

OR|GINAL
In the Unitied States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 00-269V
Filed: August 22, 2014
Not to be Published
A\.\G 'l 'Z 20th
ELAINE PIETRUCHA, *
mother of B.P., a minor, *
* Autism; Decision Without a Hearing;
Petitioner, * lnsufficient Proof; Dismissal
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V' >l<
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SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
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Respondent. *
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DECISIoN‘
HASTINGS, Special Master
Petitioner filed a petition for Vaccine Compensation in the National Vaccine Injury
Compensation Program ("the Program"),z on l\/lay 8, 2000, alleging that her child, B.P., was
injured by a vaccine or vaccines listed on the Vaccine Injury Table. See § 14.
1 Because this unpublished decision contains a reasoned explanation for the action in this case, 1 intend to post this
decision on the United States Court of Federal C1aims' website, in accordance with the E-Government Act of 2002,
Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (codit``ied as amended at 44 U.S.C. § 3501 note (2006)). In
accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to delete medical or other
information, the disclosure of which would constitute an unwarranted invasion of privacy. lf, upon review, 1 agree
that the identified material fits within this det``inition, 1 will delete such inaterial from public access.
2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100
Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 et seq. (hereinai’ter "Vaccine Act" or "the Act"). Hereafter,
individual section references will be to 42 U.S.C. § 300aa of the Act.
1
FACTS
Petitioner’s son, B.P., was born by Cesarean section on April 28, l996. (See Petitioner’s
Exhibit ("Pet. Ex.") D, p. 2.)3 During his first year of life B.P. received routine pediatric
immunizations. (Pet. Ex. D, p. l.) Gn November 14, 1996, B.P.’s development was described as
normal for his age. (Pet. Ex. D, p. 9.). On February l l, 1997, the pediatrician noted that B.P.
was able to take three steps and say the words "mama" and "dada." (Pet. Ex. D, p. ll.)
On May 9, l997, the pediatrician recorded that B.P. had a "normal exam," was "walking
well," and could say "kitty, dada, mama." (Pet. Ex. D, p. 12.) He received measles-mumps-
rubella ("l\/ll\/IR") and chickenpox ("Varivax") vaccinations during this visit, when he was one
year old. (Pet. Ex. D, pp. l, 12.) Three months later, on August ll, 1997, the pediatrician’s
next entry characterized B.P. as a "well child,” but noted that he had been suffering from loose
stools for two weeks. (Pet. Ex. D, p. 13.) B.P. received diphtheria-pertussis-tetanus ("DPT") and
bacterial meningitis ("l~lib") vaccinations during this visit. (Id.)
Petitioner contacted the pediatrician’s office by telephone on August 21, 1997, to report
that B.P. had suffered from loose bowel movements for about five days, but he was well
otherwise, and did not exhibit fever or chills. (Pet. Ex. D, p. 14.) Due to this ongoing diarrhea, a
laboratory study of B.P.’s stool was perf``ormed, which did not detect any anomalies, and on
August 29, 1997, the pediatrician noted that the diarrhea "was less." (Pet. Ex. D, pp. 14-16.)
Petitioner contacted the pediatrician’s office by telephone on October 6, 1997, to report a
bruise and a small cut on B.P.’s heel. (Pet. Ex. D, p. l7.) The next entry in the pediatrician’s
record, on November 24, 1997, included a notation that B.P.’s development was marred by
"spotty speech" and that his mother was concerned about "temper tantrums." (Pet. Ex. D, p. l7.)
B.P. received an oral polio vaccination during this visit, when he was about eighteen months old.
(Id.) Further notations, on November 26 and 29, indicate that he suff``ered from fever, diarrhea,
and cranl418 F.3d 1274, 1278 (Fed. Cir. 2()05.)
Petitioner did not respond to these Orders, and therefore, l issued an Order to Show Cause as to
why this petition should not be dismissed for failure to prosecute the case. (See Order, filed Dec.
8, 201 l.) In response, Petitioner filed a lengthy narrative letter discussing various potential
theories of causation, along with some medical records and medical literature (r$``ee Response,
filed Jan. 9, 2012.)
()ne month later, Petitioner filed the letter of Lisa Rankin, M.D., on February l3, 2012
("Letter #l").4 In that letter, Dr. Rankin expressed her opinion that "it does appear that the
circumstances under which [B.P.] was vaccinated played a role in his development of this
chronic encephalopathy," and, "[B.P.] may have an underlying mitochondrial disorder or
dysfunction that played a role by making him less able to deal with the numerous vaccines that
are given during a short period of time." (Letter #l, filed Feb. l3, 2()12.) On February 22, 2012,
l issued an Order indicating that the letter of Dr. Rankin was not sufficient to satisfy the statutory
requirements for compensation. l directed Petitioner to file a supplementary expert report clearly
opining "that one or more vaccinations more probably than not played a substantial role in
causing B.P.’s injury." (.S``ee Order, filed Feb. 22, 2()12.)
4 As there are several letters/reports from Dr. Rankin filed in support of this claim, each addressed "To Whom lt
I\/lay Coitcerii," l will number them for ease of reference, as l,etter t¢l, #2, #3, etc.
4
Petitioner filed another letter from Dr. Rankin on March 26, 2012, which described B.P.’s
medical history as follows:
lt is very clear that there was a series of poor decisions that were made on the part
of the providers combined with the use of several vaccines that are known to be
associated with adverse reactions, including Encephalopathy. .. As you follow
through the notes you can see reactions with each set of [B.P.’s] vaccines getting
progressively worse and culminating in seizures. This leaves no room for doubt
that [B.P.’s] chronic Encephalopathy is a vaccine-related injury.
(Expert Report, filed l\/larch 26, ZOlZ.)("Letter #2.") In response, l directed Respondent to file a
"Rule 4 report" and an expert report. (Order, filed April 19, 2()l2.)
Respondent’s Report ("Resp. Rep."), filed on June 15, 2012, contended that Dr. Rankin’s
opinion letters were vague and conclusory, contained factual inconsistencies, and did not provide
a theory of vaccine causation. (Resp. Rep., pp. l6-l7.) Respondent noted, in particular, that Dr.
Rankin herself had acknowledged the lack of evidence to support a finding that B.P. had a
mitochondrial disorder.§ (Id., p. l7.) Respondent countered Dr. Rankin’s allegation regarding
repeated adverse reactions to vaccines, in Letter #2, by observing that the medical records
mention only one incident of a post-vaccinal reaction, consisting only of several hours of
fussiness and redness at the injection site. (Ia’.) Further, the incidents described by the treating
neurologists as "tremors" (Petitioner’s Ex. E, pp. 4-5, and Ex. F, p. 2) did not have any temporal
association with a vaccination, nor were they diagnosed as seizures by the neurologists. (Resp.
Rep., p. 18.) Respondent’s Report concluded that the record in this case lacks preponderant
support of vaccine causation of B.P.’s injury, and should, therefore, be dismissed. (Ia’.)
Respondent summarized those contentions in a Motion for Appropriate Relief, arguing
that due to the insufficiencies of Petitioner’s expert reports, Respondent should not be required to
provide a responsive expert report. (See l\/lotion, filed june 15, 20l2.) Further, Respondent’s
l\/lotion requested the issuance of an order directing Petitioner to show cause why this case
should not be dismissed due to insufficient proof. (Id.)
A digitally-recorded status conference was held to discuss these issues, on July 10, 2()12,
with the participation ofPetitioner, Elaine Pietrucha, and Respondent’s counsel, Ann Martin.
Petitioner was instructed to discuss with her expert witness "the preparation of an expert report
that explains in detail how one or more specific vaccines caused [B.P.’s] injuries." (Order, filed
July ll, 2()12.)
On january l5, 2()13, Petitioner filed another letter from Dr. Rankin, which stated that
"there is no room for doubt that [B.P.’s] chronic encephalopathy had a clear causative event that
5 Respondent cited Dr. Rankin’s statement that B.P. "may have an underlying mitochondrial disorder," followed by
the acknowledgement that B.P. "has never had any workup along those lines." (Resp. Rep., pp. 16-17, citing Letter
#l, Feb. 13, 20\2.)
was unfortunately exacerbated multiple times by a series of poor choices made by his medical
providers." (See Response, filed Jan 15, 2013, p. 2.) ("Letter #3.") This letter did not include
any statement that B.P.’s injuries were caused by a vaccination.(’ l authorized an additional six
months for Petitioner to obtain an adequate expert report. (See Order, filed Jan. l8, 2013.) When
nothing was filed in response, on August 22, 2013, l issued an Order directing Petitioner to show
cause why this case should not be dismissed for failure to prosecute. Petitioner responded on
September 20, 2013, requesting more time to comply. An additional thirty day enlargement of
time was allowed. (See Order, filed Sept. 25, 2()13.)
Petitioner then filed another letter from Dr. Rankin, which reviewed B.P.’s medical
history from 1996 to 1998, and opined that B.P. "was transformed from a Neurotypical child to
the very affected adolescent he is today as a result of a vaccination schedule that was used in a
child who was obviously suffering from its detrimental effects." (See Notice, filed Oct. 25,
2013, p.3.) ("Letter #4.") After reviewing this document, l filed an order indicating that Dr.
Rankin’s report again was not sufficient to satisfy Petitioner’s burden of proving that B.P. was
injured by a vaccination. (See Order, filed Nov. l, 2013.) ln this Order, l provided specific
instructions regarding what an appropriate expert report must include, and allowed Petitioner
another three months to file a supplementary expert report. (ld.)
On February 3, 2()14, Petitioner filed a response that did not include the required
supplemental expert report. On February 5, 2()14, l issued an Order indicating that Petitioner’s
response was not sufficient to satisfy Petitioner’s burden of proving that B.P.’s injuries were
caused by a vaccination. That Order required Petitioner to file a supplemental expert report
within 30 days, and again provided explicit instructions as to what that report must contain.
Petitioner has not filed anything in response to my Order of February 5, 20l4.
III
THE ()MNIBUS AUTISM PROCEEDING ("OAP")
T his case is one of more than 5,4()0 cases filed under the Program in which petitioners
alleged that conditions known as "autism" or "autism spectrum disorder" ("ASD") were caused
by one or more vaccinations. A detailed history of the controversy regarding vaccines and
autism, along with a history of the development of the OAP, was set forth in King v. HHS, No.
03-584V, 2010 WL 892296, at *5-10 (Fed. Cl. Spec. Mstr. Mar l2, ZOl()), and will not be
repeated here.
Ultimately, the Petitioners’ Steering Committee ("PSC"), an organization formed by
" 1 note that in Letter #3 Dr. Rankin stated that she had provided care for B.P., "f``or several years." (Letter #3, filed
Jan. l5, 2013) However, Dr. Rankin’s own medical records concerning B.P. during those years have not been filed
into the record of this case.
attorneys representing petitioners in the OAP, litigated six test cases presenting two different
theories on the causation ofASDs. The first theory alleged that the measles portion of the
measles, mumps, rubella ("MMR") vaccine could cause ASDs. That theory was presented in
three separate Program test cases during several weeks of trial in 2007. The second theory
alleged that the mercury in thimerosal~containing vaccines could directly affect an infant’s brain,
thereby substantially contributing to the causation of ASD. That theory was presented in three
additional test cases during several weeks of trial in 2008.
Decisions in each of the three test cases pertaining to the PSC’s_/z``rsl‘ theory rejected the
petitioners’ causation theories. Cedi``llo v. HHS, No. 98~916\/, 2009 WL 33l968 (Fed. Cl. Spec.
Mstr. Feb. 12, 2009), q]j”’d, 89 Fed. Cl. 158 (2009), af]"d, 617 F.3d 1328 (Fed. Cir. 2010);
Hazlehurst v. HHS, No. 03-654\/, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. l2, 2009), aff’d,
88 Fed. Cl. 473 (2009), q/j"’d, 604 F.3d 1343 (Fed. Cir. 2010); Snya’er v. HHS, No. 0l-l62V,
2009 WL 332044 (Fed. Cl. Spec. l\/lstr. Feb. l2_, 2009), q/j"’d, 88 Fed. Cl. 706 (2009).7 Decisions
in each of the three "test cases" pertaining to the PSC’s second theory also rejected the
petitioners’ causation theories, and the petitioners in each of those three cases chose not to
appeal. Dwyer v. HHS, No. 03-1202\/, 2010 WL 892250 (Fed. Cl. Spec. l\/lstr. l\/lar. l2, 20l0);
Kz``ng v. HHS, No. 03-584\/, 2010 WL 892296 (Fed. Cl. Spec. Mstr. l\/Iar l2, 2010); Mead v.
HHS, No. 03~215\/, 2010 WL 892248 (Fed. Cl. Spec. l\/lstr. l\/lar. l2, 2010). Thus, the
proceedings in these six test cases concluded in 20l0.
IV
ANALYSIS
To receive compensation under the Program, Petitioner must prove either l) that B.P.
suffered a "Table lnj ury" - i.e., an injury falling within the Vaccine Injui'y Table - corresponding
to one of B.P.’s vaccinations, or 2) that B.P. suffered an injury that was actually caused by a
vaccine. See §§ 300aa-l3(a)(l)(A) and 300aa-l l(c)(l). Under the Vaccine Act, a special master
cannot find that Petitioner has proven her case by a preponderance of the evidence, based upon
"the claims of a Petitioner alone, unsubstantiated by medical records or by medical opinion."
§300aa-l 3(a) (2006). Petitioner has failed to file sufficient evidence in this case.
The contemporaneous medical records of B.P.’s pediatrician document a normal infancy
and the administration of routine infant vaccinations. There are several notations indicating that
he sometimes suffered from episodes of "loose stools" or diarrliea. (Pet. Ex. D, pp. l3-l6.)
There were no aberrant neurological symptoms noted until November 24, l997, when the
pediatrician recorded that Petitioner expressed concerns about B.P.’s “spotty speech" and
"temper tantrtims." (Ex. D, p. l7.) Thus, symptoms of the condition later identified as "autism"
began to manifest in B.P. during the final months of l997.
7The petitioners in Sriyder did not appeal the decision of the U.S. Court of Federal Claims.
7
ln the months preceding November 1997, B.P. received DPT and Hib vaccinations on
August ll, 1997, and Varivax and Ml\/IR vaccinations on May 9, l997. During these six
months, May through November of 1997, there were various occasions when Petitioner
contacted the pediatrician to report B.P.’s diarrhea (Pet. Ex. D, pp. 14-15), and a minor cut on his
heel (Id., p. 17). If behavioral symptoms of B.P.’s developmental problems actually occurred
earlier than November 1997, then they were not of such severity that they were reported by
Petitioner at the time, or recorded by the pediatrician.
A. Table Injury
Neither petitioner’s Amended Petition, filed on September 4, 2001 , nor the four opinion
letters of Dr. Rankin specifically allege that B.P. suffered a "Table Injury" in this case.
However, Dr. Rankin contends that "B.P.’s chronic Encephalopathy is a vaccine-related inj ury."
(Letter # 2, filed l\/Iarch 26, 2012.) Dr. Rankin modified this contention in Letter #3, by
suggesting that B.P. suffered a chronic encephalopathy that was "exacerbated multiple times by a
series of poor choices made by his medical providers." (Letter #3, filed January l5, 2013.) T he
"poor choices" alluded to in this statement presumably were the choices to administer
vaccinations. In Letter #4, Dr. Rankin opines that B.P. was "transformed from a Neurotypical
child into one suffering from a chronic Encephalopathy," as the result of "a series of poor
decisions made by his medical providers." (Letter #4, filed Oct. 25, 2013, p. 3.) Again, the
"poor decisions," alluded to in this letter, seem to be the decisions to administer vaccines. Thus,
although Dr. Rankin’s letters are rather vague, she appears to hold the opinion that B.P.’s
neurological condition is the result of an encephalopathy that was either caused or exacerbated
by a series of vaccinations that are included in the Vaccine injury Table.
F or the purpose of awarding compensation under the Program, the Vaccine Injury Table
("Table") defines the circumstances in which causation of an injury may be presumed to be
vaccine-related; that is, those circumstances which determine the existence of a "Table Injury."
See Turner v. HPIS, 268 F.3d 1334, 1337 (Fed. Cir. 2001); §300aa-l l(c)(l); §300aa-l4.
An "encephalopathy" is defined in the Table as "any significant acquired abnormality of,
or injury to, or impairment of function of the brain." §300aa~l4(b)(3)(A). The Table includes a
section entitled Qualifications and Aids to interpretation ("QAI"),$ which further limits the
meaning of the term "encephalopathy." According to the QAI, a vaccinee is considered to have
suffered a Table encephalopathy if the vaccinee manifests an injury consistent with the definition
of an czcule encephalopathy, within the appropriate time period, and if a chronic encephalopathy
persists for more than 6 months after the immunization 42 C.F.R. §l00.3(b)(2). Thus, a Table
encephalopathy is an acute encepahlopathy that is followed by a chronic encephalopathy that
lasts more than six month.
8 The QAl section ofthe Vaccine injury Table, 42 C.F.R. § l00.3(b), contains definitions for the terms used in the
Table. See Althen v. H/~IS, 58 Fed. Cl. 270, 280 (2005), c_z/j"d, 418 F.3d 1274 (Fed. Cir. 2005) (noting that the QAI
should be used to interpret key terms found in the Table).
An "acute" encephalopathy is defined as "one that is sufficiently severe so as to require
hospitalization (whether or not hospitalization occurred)." § l00.3(b)(2)(i). For children less than
18 months of age who present without an associated seizure event, an acute encephalopathy is
indicated by a significantly decreased level of consciousness lasting for at least 24 hours.
§ l00.3(b)(2)(i)(A). Section l00.3(b)(2)(i)(D) of the QAI further states that a "significantly
decreased level of consciousness" is indicated by "the presence of at least one of the following
clinical signs for at least 24 hours or greater":
(l) Decreased or absent response to environment (responds, if at all, only to loud
voice or painful stirnuli);
(2) Decreased or absent eye contact (does not fix gaze upon family members or
other individuals); or
(3) Inconsistent or absent responses to external stimuli (does not recognize
familiar people or things).
l00.3(b)(2)(i)(D). The QAI also sets forth symptoms that the Table identifies as not sufficient to
prove an acute encephalopathy:
The following clinical features alone, or in combination, do not demonstrate an
acute encephalopathy or a significant change in either mental status or level of
consciousness as described above: Sleepiness, irritability (fussiness), high-pitched
and unusual screaming, persistent inconsolable crying, and bulging fontanelle.
Seizures in themselves are not sufficient to constitute a diagnosis of
encephalopathy. In the absence of other evidence of an acute encephalopathy,
seizures shall not be viewed as the first symptom or manifestation of the onset of
an acute encephalopathy.
§ l00.3(b)(2)(i)(E).
In this Pielrucha case, Dr. Rankin makes reference to B.P.’s "encephalopathy" in her
Letters #2, #3, and #4. There are two reasons why this characterization by Dr. Rankin does not
support a "Table Injury" claim.
First, Dr. Rankin, who is the only medical professional who opines that B.P. suffered an
"encephalopathy," always referenced a "chronic" encephalopathy. The term "encephalopathy"
is very specifically defined in the QAI of the Vaccine injury Table as beginning with an "acute"
event. 42 C.F.R. §l 00.3(b). There is no acute event described anywhere in B.P.’s medical
records that resembles a "significantly decreased level of consciousness lasting for at least 24
hours." 42 C.F.R. §l 00.3(b)(2)(A). Thus, even if l were to accept Dr. Rankin’s written opinion
regarding an alleged "chronic" encephalopathy, that would still not satisfy the criteria required
by the Vaccine injury Table.
Second, l note that neither of the neurologists who examined B.P. in 1998 and 2000
9
diagnosed any sort of "encephalopathy," with either an acute, or a chronic manifestation. (See
Pet. Exs. E and F.) Both doctors were asked to examine B.P. after he began to exhibit adverse
neurological symptoms in late l997. Dr. Elliott Grossman recorded the assessment "Autism"
(Pet. Ex. E, p. 4), and Dr. Donald Younkin opined that B.P. exhibited "classic signs of infantile
autism." (Pet. Ex. F, p. 2.)
There is insufficient evidence to show that B,P. suffered an acute encephalopathy
qualifying as a Table injury.
B. Causation in fact
The medical opinion letters of Dr. Lisa Rankin do not provide persuasive evidence
indicating that B.P.’s autism spectrum disorder was vaccine-caused Dr. Rankin’s opinions in
these letters are conclusory, and they do not provide: l) a medical theory causally connecting the
vaccination and the inj ury; 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
causation and injury.
C. Decisi0n without hearing
The petition in this case was filed on l\/lay 8, 20()0, almost fourteen years ago.
Proceedings were stayed for about six years to allow the OAP test cases to be fully litigated, as
described in Section III. Despite the great similarities between the issues presented in those OAP
test cases and the issues in this case, Petitioner elected to continue with her claim after the
resolution of the test cases. Since 2008, Petitioner has been allowed ample opportunity to file
new evidence to support her claim. Petitioner has filed four expert reports, none of which stated
a theory of vaccine causation with enough clarity to necessitate a responsive expert report from
Respondent. Petitioner has received explicit instructions, on several occasions, as to what an
expert report must include. On February 5, 2014, my most recent procedural Order repeated
those instructions and allowed Petitioner an additional 30 days to file a supplemental expert
opinion letter. Petitioner has not done so.
D. C0nclusi0n
Although I have given Petitioner years in which to file an adequate expert report, she
failed to do so, and now has made no response to my Order of February 5, 2014. 1 will therefore
. ( . . . . .
rule on the record as it now stands.) lt is clear from the record in this case that Petitioner has
9 Special l\/lasters may adjudicate cases based upon the written record without conducting an evidentiary hearing
§lZ(d)(3)(B)(v); Vaccine Rule X(d): see al.s'o, l’/um)izer v. HHS, 24 Cl.Ct. 304, 307 (1991). Befoi'e deciding a case
based upon a written record, the special master must ensure that both parties have a full and fair opportunity to
present their cases Hovey v. HHS, 38 Fed. Cl. 397, 400~0\ (1997) (aft``irming special master’s decision denying
petitioner’s request for an evidentiary liearing). Further, the special master must ensure that, even without a hearing,
a record is created which is sufficient to allow review of the ultimate decision on compensation See Canzpbell v.
l~Il~/S, 69 Fed. Cl. 775, 778 (2006); H<)vey, 38 Fed.Cl. at 401; Dicker.von v. HHS, 35 Fed. Cl. 593, 598 (\996);
Mu)'phy v. HHS, 23 Cl.Ct. 726, 730, a_]’d, 968 F.Zd 1226 (Fed.Cir.l992), cerl. dem°ed, 506 U.S. 974 (1992).
10