Coombs v. Secretary of Health and Human Services ( 2014 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 08-0818V
(To be published 1)
*************************
RICHARD COOMBS and VILETTA *
COOMBS, natural parents and guardians *
of RWC, a minor, *
*
Petitioners, * Filed: April 8, 2014
*
v. *
SECRETARY OF HEALTH AND * Vaccine Act Entitlement;
HUMAN SERVICES * Causation-in-fact; MMR-Varivax/
* Autism Spectrum Disorder.
*
Respondent. *
*
*************************
Lawrence Gene Michel, Salina, Kansas, for Petitioners.
Traci R. Patton, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION
HASTINGS, Special Master.
This is an action in which Petitioners, Richard and Viletta Coombs, seek an award under
the National Vaccine Injury Compensation Program (hereinafter “the Program 2), on account of
their son RWC’s autism spectrum disorder (“ASD”), that they believe was caused by one or both
of a measles, mumps, rubella (“MMR”) vaccination and a Varvivax vaccination, administered to
their son on November 14, 2005. For the reasons set forth below, I conclude that Petitioners are
not entitled to an award.
1
Because I have designated this document to be published, this document will be made
available to the public unless petitioners file, within fourteen days, an objection to the disclosure
of any material in this decision that would constitute “medical files and similar files the
disclosure of which would constitute a clearly unwarranted invasion of privacy.” See 42 U.S.C. §
300aa-12(d)(4)(B); Vaccine Rule 18(b).
2
The applicable statutory provisions defining the Program are found at 42 U.S.C. §
300aa-10 et seq. (2006 ed.). Hereinafter, for ease of citation, all "§" references will be to 42
U.S.C. (2006 ed.).
1
I
THE APPLICABLE STATUTORY SCHEME
Under the National Vaccine Injury Compensation Program, compensation awards are
made to individuals who have suffered injuries after receiving vaccines. In general, to gain an
award, a petitioner must make a number of factual demonstrations, including showing that an
individual received a vaccination covered by the statute; received it in the United States; suffered
a serious, long-standing injury; and has received no previous award or settlement on account of
the injury. Finally – and the key question in most cases under the Program – the petitioner must
also establish a causal link between the vaccination and the injury. In some cases, the petitioner
may simply demonstrate the occurrence of what has been called a “Table Injury.” That is, it may
be shown that the vaccine recipient suffered an injury of the type enumerated in the “Vaccine
Injury Table,” corresponding to the vaccination in question, within an applicable time period
following the vaccination also specified in the Table. If so, the Table Injury is presumed to have
been caused by the vaccination, and the petitioner is automatically entitled to compensation,
unless it is affirmatively shown that the injury was caused by some factor other than the
vaccination. § 300aa-13(a)(1)(A); § 300 aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).
In other cases, however, the vaccine recipient may have suffered an injury not of the type
covered in the Vaccine Injury Table. In such instances, an alternative means exists to
demonstrate entitlement to a Program award. That is, the petitioner may gain an award by
showing that the recipient’s injury was “caused-in-fact” by the vaccination in question. § 300aa-
13(a)(1)(B); § 300aa-11(c)(1)(C)(ii). In such a situation, of course, the presumptions available
under the Vaccine Injury Table are inoperative. The burden is on the petitioner to introduce
evidence demonstrating that the vaccination actually caused the injury in question. Althen v.
HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. HHS, 940 F.2d 1518, 1525 (Fed. Cir.
1991). The showing of “causation-in-fact” must satisfy the “preponderance of the evidence”
standard, the same standard ordinarily used in tort litigation. § 300aa-13(a)(1)(A); see also
Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that standard, the petitioner must
show that it is “more probable than not” that the vaccination was the cause of the injury. Althen,
418 F.3d at 1279. The petitioner need not show that the vaccination was the sole cause or even
the predominant cause of the injury or condition, but must demonstrate that the vaccination was
at least a “substantial factor” in causing the condition, and was a “but for” cause. Shyface v.
HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999). Thus, the petitioner must supply “proof of a logical
sequence of cause and effect showing that the vaccination was the reason for the injury;” the
logical sequence must be supported by “reputable medical or scientific explanation, i.e., evidence
in the form of scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278; Grant v.
HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992).
The Althen court also provided additional discussion of the “causation-in-fact” standard,
as follows:
Concisely stated, Althen’s burden is to show by preponderant evidence that the
vaccination brought about her injury by providing: (1) a medical theory causally
2
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 proximate temporal relationship between vaccination and injury. If
Althen satisfies this burden, she is “entitled to recover unless the [government]
shows, also by a preponderance of the evidence, that the injury was in fact caused
by factors unrelated to the vaccine.”
Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner need not
necessarily supply evidence from medical literature supporting petitioner’s causation contention,
so long as the petitioner supplies the medical opinion of an expert. (Id. at 1279-80.) The court
also indicated that, in finding causation, a Program fact-finder may rely upon “circumstantial
evidence,” which the court found to be consistent with the “system created by Congress, in
which close calls regarding causation are resolved in favor of injured claimants.” (Id. at 1280.)
Since Althen, the Federal Circuit has addressed the causation-in-fact standard in several
additional rulings, which have affirmed the applicability of the Althen test, and afforded further
instruction for resolving causation-in-fact issues. In Capizzano v. HHS, 440 F.3d 1317, 1326
(Fed. Cir. 2006), the court cautioned Program fact-finders against narrowly construing the
second element of the Althen test, confirming that circumstantial evidence and medical opinion,
sometimes in the form of notations of treating physicians in the vaccinee’s medical records, may
in a particular case be sufficient to satisfy that second element of the Althen test. Both Pafford v.
HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006), and Walther v. HHS, 485 F.3d 1146, 1150 (Fed. Cir.
2007), discussed the issue of which party bears the burden of ruling out potential non-vaccine
causes. DeBazan v. HHS, 539 F.3d 1347 (Fed. Cir. 2008), concerned an issue of what evidence
the special master may consider in deciding the initial question of whether the petitioner has met
her causation burden. The issue of the temporal relationship between vaccination and the onset
of an alleged injury was further discussed in Locane v. HHS, 685 F.3d 1375 (Fed. Cir. 2012), and
W.C. v. HHS, 704 F.3d 1352 (Fed. Cir. 2013). Moberly v. HHS, 592 F.3d 1315 (Fed. Cir. 2010),
concluded that the “preponderance of the evidence” standard that applies to Vaccine Act cases is
the same as the standard used in traditional tort cases, so that conclusive proof involving medical
literature or epidemiology is not needed, but demonstration of causation must be more than
“plausible” or “possible.” Both Andreu v. HHS, 569 F.3d 1367 (Fed. Cir. 2009), and Porter v.
HHS, 663 F.3d 1242 (Fed. Cir. 2011), considered when a determination concerning an expert’s
credibility may reasonably affect the outcome of a causation inquiry. Broekelschen v. HHS, 618
F.3d 1339 (Fed. Cir. 2010), found that it was appropriate for a special master to determine the
reliability of a diagnosis before analyzing the likelihood of vaccine causation. Lombardi v. HHS,
656 F.3d 1343 (Fed. Cir. 2011), and Hibbard v. HHS, 698 F.3d 1355 (Fed. Cir. 2012), both again
explored the importance of assessing the accuracy of the diagnosis that supports a claimant’s
theory of causation. Doe 11 v. HHS, 601 F.3d 1349 (Fed.Cir. 2010) and Deribeaux v. HHS, 717
F.3d 1363 (Fed. Cir. 2013), both discuss the burden of proof necessary to establish that a “factor
unrelated” to a vaccine may have caused the alleged injury.
Another important aspect of the causation-in-fact case law under the Program concerns
the factors that a special master should consider in evaluating the reliability of expert testimony
and other scientific evidence relating to causation issues. In Daubert v. Merrell Down
Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court listed certain factors that federal
3
trial courts should utilize in evaluating proposed expert testimony concerning scientific issues.
In Terran v. HHS, 195 F.3d 1302, 1316 (Fed. Cir. 1999), the Federal Circuit ruled that it is
appropriate for special masters to utilize Daubert’s factors as a framework for evaluating the
reliability of causation-in-fact theories presented in Program cases.
II
PROCEDURAL HISTORY
On November 17, 2008, Petitioners filed, pro se, a “Short-Form Autism Petition for
Vaccine Compensation” under the National Vaccine Injury Compensation Program, on behalf of
their son, RWC. (See Petition (“Pet”) at 1.) The case was originally assigned to Special Master
Golkiewicz. (Notice of Assignment filed Nov. 17, 2008, ECF No. 2.)
Respondent’s counsel filed a “Rule 4 Report” on December 18, 2008, noting
inadequacies in the petition. (ECF No. 5.) On January 30, 2009, attorney Lawrence Michel filed
a motion to substitute as counsel for the pro se Petitioners. (ECF No. 6.)
Petitioners filed RWC’s medical records between April 24, 2009, and October 13, 2011.
(See Exs. 1-50, 54.) 3
On April 29, 2010, Petitioners filed a motion to remove their claim from the Omnibus
Autism Proceeding (OAP). 4 (ECF No. 23.) Special Master Golkiewicz granted this motion on
3
Exhibits filed by Petitioners are identified by numbers. Exhibits filed by Respondent are
identified by letter.
4
The Omnibus Autism Proceeding was a special proceeding under the Vaccine Act in
which three special masters addressed the general issue of whether certain vaccines can
contribute to causing autism. On February 12, 2009, those three special masters separately
issued decisions in the first three “test cases” in the OAP: Cedillo v. HHS, No. 98-916V, 2009
WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009); Snyder v. HHS, No. 01-162V, 2009 WL
332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009); Hazlehurst v. HHS, No. 03-654V, 2009 WL
332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009). All three decisions determined that the evidence
failed to demonstrate any general causal connection between the MMR vaccine and the
development of autism spectrum disorders. These decisions were each subsequently affirmed,
on appeal, by three different judges of the U.S. Court of Federal Claims. Cedillo v. HHS, 89 Fed.
Cl. 158 (2009); Snyder v. HHS, 88 Fed. Cl. 706 (2009); Hazlehurst v. HHS, 88 Fed. Cl. 473(2009). Subsequently, the two cases that were appealed to the U.S. Court of Appeals for the
Federal Circuit, Cedillo and Hazlehurst, were again affirmed. Cedillo v. HHS, 617 F.3d 1328(Fed. Cir. 2010); Hazlehurst v. HHS, 604 F.3d 1343 (Fed. Cir. 2010). (The Snyder case was not
appealed to the Federal Circuit.) In March of 2010, the same three special masters issued
opinions in three more OAP “test cases,” this time rejecting the second causation theory
presented in the OAP, that thimerosal-containing vaccines can cause autism. King v. HHS, No.
03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead v. HHS, No. 03-215V,
2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Dwyer v. HHS, No. 03-1202V, 2010 WL
4May 10, 2010. (ECF No. 24.) Petitioners then filed an amended petition on September 17, 2010,
alleging that the MMR and Varivax vaccines that RWC received on November 14, 2005,
“aggravated [RWC’s] underlying Complex I and III deficiencies related to mitochondrial
disease, caused [RWC] to develop chronic illness, high fevers, become developmentally delayed,
and develop features consistent with Autism Spectrum Disorder.” (Amended Petition
(“Amended Pet.”) at 1.) The case was reassigned to me on February 11, 2011. (ECF No. 38.)
On April 13, 2011, Petitioners filed an expert report from J. Ivan Lopez, M.D., and his
curriculum vitae (“CV”). (Exs. 51, 52.) Petitioners additionally filed supplemental expert reports
from Dr. Lopez on June 29, 2011, and July 31, 2012. (Exs. 53, 55.)
On November 19, 2012, I conducted an evidentiary hearing in Washington, D.C. (See
Transcript of Proceedings (“Tr.”), ECF No. 61.) RWC’s mother, Ms. Coombs, and Petitioners’
expert Dr. Lopez testified for Petitioners; experts Dr. Korson and Dr. Wiznitzer testified for
Respondent. (Id.)
On April 17, 2013, Petitioners’ counsel filed their opening post-hearing brief. On July 17,
2013, Respondent’s counsel filed a responsive post-hearing brief, and on September 16, 2013,
Petitioners’ counsel filed a reply brief.
III
STATEMENT OF FACTS
RWC was born healthy on July 6, 2004. (Exs. 1, 3, 13, 19, 39, 40.) He was discharged on
July 8, 2004. (Ex. 13, p. 431.) It is noted in RWC’s medical history that RWC was hospitalized
shortly after being born, on account of dehydration due to poor “p.o. intake from being
exclusively breast fed and needed to stay for two days.” (Ex. 16, p. 628.)
RWC’s immunization history began with administrations of DTaP on September 17,
2004, November 8, 2004, January 11, 2005, and February 9, 2006, OPV on September 17, 2004,
November 8, 2004, and February 9, 2006; hepatitis B on July 6, 2004, August 5, 2004, and
April 25, 2005; and Prevnar on September 17, 2004, November 8, 2004, January 11, 2005, and
July 6, 2005. (Ex. 9, p. 282.)
On November 14, 2005, RWC’s sixteen-month MMR and Varivax vaccinations were
administered at the office of Dr. Brunnel. (Ex 34, p. 1622.) The record for that November 14
visit indicates that by this time RWC was experiencing oral and texture aversions. (Id.) During
his next pediatrician visit, on December 1, 2005, RWC was noted to be “healthy appearing,
happy and extremely active.” (Ex. 9, p. 309) No fever is mentioned in RWC’s December 1
medical record. (Id.)
892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010). None of those decisions were appealed. For
further discussion of the OAP, see Cedillo v. HHS, 2009 WL 331968 at *8-11.
5
On December 19, 2005, RWC had a pediatric visit where he presented with decreased
feeding, coughing, vomiting, stuffy nose, and a maximum temperature of 99-100 degrees. 5 (Ex.
16, pp. 705-06.) RWC was noted on December 20, 2005, to have the same aforementioned
symptoms, alongside diarrhea and an elevated temperature around 102 degrees. (Ex. 16, p. 706.)
RWC experienced the same symptoms the next day on December 21, 2005, and was
noted as unable to breathe through his nose and “cannot eat or drink; has had no liquid or solid
intake, and his temperature was elevated to around 103 degrees.” (Ex. 16, p. 706.) RWC was
thereafter admitted to Tallahassee Memorial Hospital on that same day for a flu-like illness and
dehydration. (Ex. 9, p. 351.) RWC’s temperature then went up to 108 degrees, but then
gradually abated; he was not treated with antibiotics. (Id., pp. 351-52.) RWC was also noted to
have “oral aversions” on that day. (Id.) RWC was thereafter discharged from Tallahassee
Memorial Hospital on December 23, 2005, with a diagnosis of viral upper respiratory tract
infection. (Id.)
In January 2006, it was noted, in RWC’s medical history from Dr. Caudill at the Mayo
Clinic, that RWC entered daycare for the first time during that month. (Ex. 22, p. 900.) The notes
indicate that “he did not do very well any time thereafter. He continually becomes sick, and his
mother describes these sicknesses as being characterized by frequent bouts of otitis media
requiring antibiotic treatment.” (Id.)
From this point forward, RWC amassed a lengthy medical history totaling in the
thousands of pages, as the Coombs family expended a great amount of effort in seeking to
diagnose and treat RWC’s condition. Ms. Coombs testified extensively about this history,
indicating that they saw more than 20 specialists on what she aptly described as a “scavenger
hunt.” (Tr. 34.) During this period RWC underwent a series of adenoidectomy and ear tube
surgeries in an effort to address his recurrent ear infections and illnesses. (Ex. 22, p. 901; Ex. 16,
p. 714.) Questions regarding whether RWC’s developmental delays could be explained at least
in part by possible hearing loss persisted during these years, while other explanations were also
pursued. (See, e.g., Ex. 17, p. 748; Tr. 37-41.)
A family service evaluation on February 7, 2006, noted that RWC “is showing significant
delays in all areas other than physical development.” (Ex. 34, p. 1976.) The evaluation note
indicates that RWC’s parents reported that RWC has been “lining up grains of rice, and lined up
all his toys. They also reported that he will search the carpet for the tiniest piece of fuzz (lint),
and will put it in his mouth.” (Id.) This behavior was observed during the visit of February 7,
2006, when RWC picked up a hair off the couch and attempted to put it in his mouth. (Id.)
On February 6, 2007, a physician report from the Developmental Evaluation and
Intervention Clinic stated that RWC had a history of sensory issues, which worsened after he
began daycare about a year prior. (Ex. 24, p. 1017.) He was noted to use signs and words and
point out to others what he wanted. (Id.) He was also noted to rub his face on the wall for
5
Ms. Coombs testified that RWC experienced a fever “on or about the same day” he
received his MMR and Varivax vaccinations. (Tr. 20-21) Ms. Coombs also offered testimony
indicating that RWC experienced a fever in early December, around the 6th or 8th. (Tr. 24.) The
fever recorded on December 19, however, is the earliest fever noted in RWC’s medical records.
6
stimulation. (Id.) This report additionally states that on the Hawaii Early Learning Profile
(“HELP”) scale at age 31 months, RWC’s corresponding developmental ages were as follows:
regulatory/sensory organization -- 30-36 months; cognitive -- 19-24 months; language -- 12-15
months; social-emotional -- 18-24 months; gross motor -- 24-26 months; fine motor -- 18-24
months; and self-help -- 18-24 months. (Ex. 24, p. 1018.) For language, he used 1-3 words in his
expressive vocabulary, and was beginning to use exclamatory expressions. (Id., p. 1019.) He
was not yet using ‘dada,’ ‘mama,’ or ‘no,’ specifically, and was not naming objects. (Id.) In the
“wrap-up” portion of this report, the physician noted that there was a concern that RWC was on
the autism spectrum. (Id., p. 1020.)
On December 1, 2008, an evaluation at the Tridas Center for Child Development elicited
a history of single word use and knowledge of shapes, numbers, and letters. (See generally Ex.
35.) RWC had immediate and delayed echolalia (repetition of words without comprehension),
and his eye contact was variable. (Ex. 35, pp. 2079-80.) He did not play interactively with peers.
(Id., p. 2080.) He had unusual hand and finger movements, and was noted to have many autistic
spectrum symptoms. 6 (Id., p. 2081.)
Eventually, RWC was referred to Childhood Neurology in Atlanta, Georgia, where he
was assessed for a possible mitochondrial disorder. (Tr. 48-50.) At Childhood Neurology, RWC
was treated by Dr. Goldstein, but was sent to a specialist, Dr. Shoffner, for a determination as to
whether he had a mitochondrial disorder. (Tr. 50-51.) Dr. Shoffner stated “I am NOT convinced
that this patient has a mitochondrial disease. A single abnormality (abnormal enzymology) is not
sufficient criteria for definitive diagnosis.” (Ex 43, p. 2334.) A neurology follow-up on
November 13, 2009, with Dr. Goldstein, listed relative deficiencies in Complex I and III, with
ongoing metabolic/genetic testing by Dr. John Shoffner.
At the present time, RWC still continues to undergo treatment for his aforementioned
symptoms. (Ex. 50, p. 51.)
IV
ISSUE TO BE DECIDED
In this case, Petitioners seek a Program award, contending that RWC’s autism spectrum
disorder was “caused-in-fact” or “aggravated” by the MMR and/or Varivax vaccinations
administered to their son on November 14, 2005. After careful consideration, I conclude that
they have failed to meet their burden. 7
6
Because RWC’s records are so extensive, it is impossible to fully catalog all of the
various clinical observations they contain. Suffice it to say that these observations do not
uniformly recognize RWC’s condition as being ASD. I gloss over these distinctions, because the
parties do not dispute that RWC does, in fact, suffer from an ASD.
7
Petitioners have the burden of demonstrating the facts necessary for entitlement to an
award by a “preponderance of the evidence.” § 300aa-12(a)(1)(A). Under that standard, the
existence of a fact must be shown to be “more probable than its nonexistence.” In re Winship,
397 U.S. 358, 371 (1970) (Harlan, J., concurring).
7
Petitioners’ theory of the case may be briefly summarized as follows. Petitioners contend
that at the time of his MMR and Varivax vaccinations, RWC had an undiagnosed underlying
mitochondrial disorder (specifically Complex I and Complex III deficiencies) and mild Autism
Spectrum Disorder. They allege that it is more likely than not that febrile episodes provoked by
RWC’s MMR and Varivax vaccines “unmasked” the underlying mitochondrial disorder by
virtue of excessive metabolic demands that RWC’s system could not meet and overcome. As a
result, RWC experienced autistic regression.
Respondent disagrees. Respondent contends that there is insufficient evidence to confirm
a diagnosis of mitochondrial disease in RWC, and that there is a lack of temporal connection
between RWC’s immunizations and onset of his developmental issues.
V
SUMMARY OF EXPERT WITNESSES’ QUALIFICATIONS AND OPINIONS
In this case, Petitioners presented an expert report and testimony from one medical
expert, and Respondent presented expert reports and testimony from two medical experts. At
this point, I will briefly summarize both the qualifications and the opinions of these expert
witnesses.
A. Petitioners’ expert
1. Dr. J. Ivan Lopez
Dr. J. Ivan Lopez attended La Salle University School of Medicine where he received a
degree in medicine in 1982. (Ex. 52, p. 10.) He thereafter became a physician and surgeon at the
National Autonomous University of Mexico in 1983. (Id.)
Dr. Lopez has extensive postgraduate experience and has held positions at Mercer
University School of Medicine, the Ramadan Hand Institute, Organon Laboratories, Servimed
Medical Group, and the “lo Octubre” Hospital in Mexico City. (Ex. 52, pp. 2-4.) From
September to October 2005, Dr. Lopez was a visiting professor of neurology at the University of
Montemorelos School of Medicine in Montemorelos, Nuevo Leon Mexico. (Id., p. 2.) From
2008-2009, Dr. Lopez held positions as the Stroke Fellowship Director at the University of
South Alabama, Clerkship Director at the University of South Alabama Department of
Neurology, and the Director at the University of Alabama Stroke Center. (Id.) From 2009-2011,
Dr. Lopez served as an Associate Professor of Pediatrics at the University of Alabama at
Birmingham, Scientist to the University of Alabama Comprehensive Neuroscience Center,
Associate Professor of Neurology, and Director of the Vascular Neurology Training Program.
(Id.; Tr. 95.) He also served as the Clerkship Director at the University of Alabama at
Birmingham, Department of Neurology from 2010-2011. (Ex. 52, p. 2; Tr. 96.)
Dr. Lopez was licensed to practice medicine in Mexico in 1986, received an Educational
Commission for Foreign Medical Graduates (“ECFMG”) certificate in 1991, received an
8
Alabama State Medical License in 1993, received a Florida Medical License in 1996, and
received a Georgia Medical License in 2001. (Ex. 52, p. 15.) He was certified in Neurosonology
by the American Society of Neuroimaging in 1995, the American Board of Psychiatry and
Neurology in Child Neurology in 2000, and by the United Council for Neurologic Subspecialties
in Headache Medicine in 2007. (Id.)
Additionally, Dr. Lopez was appointed as a Fellow of the American Academy of
Neurology from 2006-2010. (Ex. 52, p. 17.) He has served on various medical committees and
received the Army Achievement Medal for services rendered at Landstuhl Regional Medical
Center during Operation Enduring Freedom and Operation Iraqi Freedom in 2006. (Ex. 52, p. 17-
18; Tr. 95-96.) Dr. Lopez maintains a clinical practice in pediatric neurology, but does not treat
any patients with mitochondrial disorder as part of that clinical practice. (Tr.133.)
From 1995- 2009, Dr. Lopez served as a co-investigator in many scientific trials
involving neurological issues, and Dr. Lopez has 13 peer-reviewed publications listed on his
curriculum vitae (“CV”). (Ex. 52, pp. 14-15.)
2. Summary of opinion of Petitioners’ expert
Dr. Lopez testified that by the nature of mitochondrial diseases, patients may be
asymptomatic until their metabolic system is taxed in excess, as in strenuous exercise, febrile
illness, and/or any concomitant condition whereby the patient must provide extra energy to meet
higher metabolic demands. (Ex. 51, p. 3; Tr. 99-100.) Dr. Lopez opined that this is exactly what
happened to RWC, arguing that although the vaccines received on November 14, 2005, did not
produce Complex I and Complex III mitochondrial deficiencies, it is more likely than not that the
febrile episodes allegedly provoked by these vaccines unmasked RWC’s underlying condition,
by virtue of excessive metabolic demands that his system could not meet and overcome. (Ex. 51,
p. 3.) As a result, RWC developed pervasive developmental delay. (Id.)
In his supplemental expert report, Dr. Lopez was asked to specify (1) which vaccine
(MMR or Varivax) caused RWC’s febrile episodes; (2) when those episodes occurred; and (3)
how those episodes aggravated, or “unmasked,” RWC’s underlying mitochondrial disorder. (Ex.
53, p. 2.) Dr. Lopez responded that as to the first question, both vaccines could have been
responsible for the febrile episodes previously mentioned. (Id.) In regard to the second question,
two weeks after he received his vaccinations, RWC started experiencing fevers and infections
that ultimately aggravated his underlying metabolic condition. (Id.) Lastly, Dr. Lopez responded
to the third question by stating that--
it is important to remember that the primary function of the mitochondria is that
of oxidative metabolism, or energy production. The brain depends highly on
oxidative metabolism and quickly becomes symptomatic when oxidative
metabolism is impaired. * * *Catabolic stress, such as infections and fever, when
energy demands are higher than in the normal, physiological state, are normally
overcome by healthy mitochondria, but in the case of [RWC], and due to his
metabolic deficiencies that is not the case; and in the background of constant
fevers as a side-effect of the vaccines given to him on 14 November, 2005 his
9
brain metabolic demands were not met and as a consequence of poor energy
production he has shown the clinical picture that has already been mentioned.
(Id.)
Dr. Lopez testified specifically that the mitochondrial deficiencies were not due to the
vaccines RWC received, since he was born with these deficiencies. (Tr. 113.) However,
Dr. Lopez believed that given his knowledge of mitochondria and how they work, “any febrile
episode, any infection that produces an excess of metabolic demands on the system may unmask
one of these conditions or, if it is already there, make it worse.” (Id.)
B. Respondent’s experts
1. Dr. Mark Sheldon Korson
Dr. Mark Sheldon Korson received an undergraduate degree from the University of
Toronto. (Ex. B, p. 1; Tr. 153.) Dr. Korson graduated from the University of Toronto in 1982
with a degree in medicine. (Id.) From 1982 to 1983, Dr. Korson held a rotating internship at St.
Joseph’s Health Center in Toronto, Canada. (Id.) From 1983 to 1986, he completed his
residency training in Pediatrics at the Hospital for Sick Children in Toronto. (Ex. B, p. 1; Tr.
153.) From 1986-1990, he received a Fellowship in Genetics at the Children’s Hospital in
Boston, Massachusetts. (Id.)
Dr. Korson was certified by the Medical Council of Canada in 1982 and the National
Board of Medical Examiners. (Ex. B, p. 1; Tr.154.) In 1989, Dr. Korson was certified by the
American Board of Pediatrics and the Royal College of Physicians of Canada. (Ex. B, p.1.) In
1993, Dr. Korson was certified by the American Board of Medical Genetics, Clinical Genetics,
and Clinical Biochemical Genetics. (Ex. B, p. 1; Tr. 154.) In 1997, he was certified by the
American Board of Pediatrics and recertified in 2002. (Id.) In 2003, he was certified by the
American Board of Medical Genetics, Clinical Genetics and Clinical Biochemical Genetics; he
was recertified in 2006 and 2010. (Id.)
Dr. Korson was appointed instructor in Pediatrics at the Harvard Medical School in
Boston, Massachusetts from 1990 to 1998. (Ex. B, p. 1.) From 1998 to 2000 he was Assistant
Professor of Pediatrics at Harvard Medical School in Boston, and from 2001 to the present, he
has served as Associate Professor of Pediatrics at Tufts University School of Medicine. (Id.)
Currently, Dr. Korson works as the Chief of the Metabolism Service within the Division of
Genetics and Metabolism at The Floating Hospital for Children at the Tufts Medical Center.
(Ex. B, p. 1; Tr. 153.)
Dr. Korson was awarded the Loewen, Ondaatje, McCutcheon & Co. Educational Award
for Excellence in Clinical Teaching in 1986, the Young Investigator Award from the Society for
Inherited Metabolic Disease in 1988, and the Excellence in Teaching Award, from Tufts
University School of Medicine in 2003. (Ex. B, p. 2.) Dr. Korson has 35 refereed articles, 15
peer-reviewed book chapters, and 17 abstracts, listed on his CV. (Id., pp. 5-8.)
10
2. Dr. Max Wiznitzer
Dr. Wiznitzer attended the Northwestern University Honors Program and specialized in
Medical Education, earning a Bachelor of Science degree in Medicine in 1975. (Ex. D, p.1.)
Dr. Wiznitzer graduated from the Northwestern University Medical School in 1977 with a degree
in medicine. (Id.) During his postgraduate training, Dr. Wiznitzer was a resident in pediatrics at
the Children’s Hospital Center in Cincinnati, Ohio from 1977 to 1980. (Id.) He also was a fellow
in developmental disorders at the Cincinnati Center for Developmental Disorders from 1980 to
1981. (Id.) He thereafter became a fellow in pediatric neurology at the Children’s Hospital from
1981 to 1984. (Id.) He received the NIH National Research Service Award fellowship in Higher
Cortical Functions from 1984 to1986. (Id., p. 3.) From 1986 to the present, Dr. Wiznitzer has
rotated between Assistant Professor of Pediatrics, Neurology, and International Health at Case
Western Reserve University. (Ex. D, p. 2; Tr. 200.)
Dr. Wiznitzer has additionally won the NIG National Research Service Award from the
Albert Einstein College of Medicine in1986, and was recognized as the Professional of the Year
from the Autism Society of Ohio in 1991. (Ex. D, p.3.) He was certified by the American Board
of Pediatrics in 1982, the American Board of Psychiatry and Neurology in Child Neurology in
1986, and the National Board of Medical Examiners in 1978. (Ex. D, p. 5; Tr. 199.) He has been
licensed in Ohio (1979), Pennsylvania (1981), and New York (1984). (Ex. D, p. 5.) Dr.
Wiznitzer served on the Editorial Board of many journals, including Pediatric Neurology,
Journal of Child Neurology, and Lancet Neurology. (Id., p. 6.) He has helped author 58 original
articles, 11 book chapters, and 55 abstracts, which are listed on his CV. (Id., pp. 13-23.)
3. Summary of opinions of Respondent’s experts
1. Dr. Korson
Dr. Korson testified that there is insufficient evidence to diagnose RWC with a
mitochondrial disorder. (Ex. A, p. 6; Tr. 183.) Dr. Korson opines that even if RWC had a
mitochondrial disorder, there is insufficient evidence that the MMR or Varivax vaccine
exacerbated that underlying mitochondrial disorder, causing an injury. (Ex. A, p.6; Tr. 185.)
Dr. Korson’s opinion is based on many different factors, including insufficient evidence to
confirm a diagnosis of mitochondrial disease in this patient; the lack of a clinical phenotype
consistent with a patient with a mitochondrial disorder; the lack of a temporal relationship
between the immunization and the onset of developmental issues; and the lack of a causative
relationship between the immunization and the patient’s speech delays. (Ex. A, p.6.)
2. Dr. Wiznitzer
Dr. Wiznitzer testified that Dr. Lopez’s opinion is not supported by the contemporaneous
medical records. (Ex. C, p. 6.) Dr. Wiznitzer opined that RWC had features of ASD prior to his
immunizations in question, had no regression of skills following any immunization, and does not
have enough clinical or laboratory findings to support the diagnosis of a mitochondrial disorder.
(Ex. C, p. 7; Tr. 210-214.)
11
VI
RESPONDENT’S EXPERTS WERE FAR MORE PERSUASIVE IN GENERAL
For all of the reasons set forth in this section and in the sections of this Decision below, I
conclude that Petitioners have failed to demonstrate that it is “more probable than not” that
RWC’s vaccinations of November 14, 2005, played any role in causing or aggravating his ASD.
And the first of the reasons for this conclusion is simply that I found Respondent’s experts, Drs.
Korson and Wiznitzer, to be far more persuasive than Petitioners’ expert, Dr. Lopez.
A. Qualifications
In this regard, I start with the qualifications of the opposing experts relative to the issues
raised by Petitioners’ claim. In short, the credentials of Respondent’s experts are vastly superior.
Although the parties agree that RWC has an Autism Spectrum Disorder, the question in this case
is whether the extent of that condition was a result of a regression resulting from an aggravation
of an underlying mitochondrial disorder, as Petitioners allege, or the onset of ASD unrelated to
any other condition, as Respondent contends. Petitioners relied on a single expert, Dr. Lopez,
who was presented as an expert in neurology. (Tr. 98.) Respondent relied on two experts . Dr.
Wiznitzer was presented not only as an expert in pediatric neurology, but also as an expert in
Autism Spectrum Disorders in particular. (Tr. 204.) Dr. Korson was presented as an expert in
both metabolic diseases and mitochondrial disorders. (Tr. 157.) Drs. Wiznitzer and Korson are
far more qualified to assess the onset of RWC’s ASD and to determine whether he in fact suffers
from a mitochondrial disorder.
1. Expertise in autism spectrum disorders
Dr. Wiznitzer has extensive experience in diagnosing and assessing ASDs. Children with
ASDs make up one of the two largest groups of patients in his clinical practice. (Tr. 202.)
During the course of his clinical practice, Dr. Wiznitzer has seen thousands of children with
ASD. (Id.) As a faculty member at Case Western Reserve University, he regularly lectures on
ASDs. (Tr. 200.) In 1989, he was part of a group working on “screening, diagnosis and
assessment of autism” with the National Institutes of Health, leading to the publication of a paper
in the Journal of Autism and Developmental Disorders. (Tr. 202.) He is currently a member of
the Autism Subcommittee of the American Academy of Pediatrics, and is the Pediatrics liaison
for the Autism Treatment Network. (Tr. 203.) He is also working on a committee at the
American Academy of Neurology putting together “guidelines for the management of autism
spectrum disorders.” (Id.) Dr. Wiznitzer has published five articles on the assessment and
evaluation of ASDs. (Tr. 204.)
In contrast, although Dr. Lopez is also a pediatric neurologist with a clinical practice (Tr.
96-97), nothing in his curriculum vitae or his hearing testimony offers any indication of expertise
particular to ASDs. Rather, Dr. Lopez testified that most of his clinical practice is devoted to
stroke and headache patients. (Tr. 97.) His curriculum vitae further demonstrates this focus.
(Ex. 52.) All of Dr. Lopez’s listed research experience is devoted to topics pertinent to strokes,
migraines, and seizures (id., pp. 4-10), as are most of his publications and oral presentations (id.,
pp. 11-15). There is no mention of ASDs in Dr. Lopez’s curriculum vitae.
12
2. Expertise in mitochondrial disorders
Dr. Korson has been working in the field of genetics and metabolism since 1990. (Tr.
154). He is board-certified in pediatrics, clinical genetics, and biochemical genetics, which
encompasses mitochondrial disorders. (Id.) He is a member of The Society of Inherited
Metabolic Disease, the American Academy of Developmental Medicine and Dentistry, and was a
founding member of the Mitochondrial Disease Action Committee (“MitoAction”). (Tr. 154-
55.) Dr. Korson currently sits on the medical advisory board for MitoAction, and was
commissioned by that organization to write a symptom guide for mitochondrial disease. (Id.) In
addition to teaching about mitochondrial disease as the Director of Metabolic Services at Tufts,
he spent four years on a Metabolic Outreach Service project which he developed, giving regular
talks about metabolic and mitochondrial disease at five different teaching hospitals. (Tr. 155.)
Dr. Korson also maintains a clinical practice in which most of his patients, two-thirds of whom
are children, suffer from some form of mitochondrial disease. (Tr. 156.) Dr. Korson has
published about ten articles on mitochondrial disease. (Tr. 157.)
Dr. Lopez, in contrast, acknowledged that he sees “very few” patients with mitochondrial
conditions in his practice, and that he does not treat these patients. (Tr. 133.) Dr. Lopez is not
board-certified in biochemical genetics, nor has he ever done any research on mitochondrial
disorders. (Id.) Dr. Lopez’s only stated experience with mitochondrial disorders stems from his
participation in a presentation of several cases of mitochondrial disease at a meeting in New
Orleans while he was in training as a resident at the University of South Alabama. (Tr. 134.)
While this presentation ultimately led to a published abstract, Dr. Lopez himself characterized
the abstract as “not really that important,” and indeed, couldn’t even remember the title. (Id.)
A particular point of disagreement between Dr. Lopez and Dr. Korson is the proper
scoring of RWC’s condition under the Nijmegen test, a set of clinical criteria used to determine
the presence of a mitochondrial disorder. Significantly, Dr. Korson uses this test in his clinical
practice (Tr. 166), while Dr. Lopez acknowledged that he was not familiar with the Nijmegen
clinical criteria prior to his involvement in this case (Tr. 149).
B. Deficiencies in Dr. Lopez’s testimony
Even more important than the vast gap in qualifications between Dr. Lopez and
Respondent’s experts, was the even greater gap in the experts’ ability to explain their opinions.
The written reports and hearing testimony of both Drs. Wiznitzer and Korson seemed to me to be
coherent and logical. In contrast, the written reports of Dr. Lopez were short and not well
explained, while his hearing testimony was often self-contradictory, and unsubstantiated by
scientific explanation. In his testimony and his reports, Dr. Lopez failed to persuasively address
questions critical to his causation theory. For the reasons discussed in Section VII below, I find
that Petitioners have failed to establish that it is “more probable than not” that RWC suffered a
mitochondrial disorder, but even setting that aside, I find as a threshold issue that Dr. Lopez has
failed to present an adequate or even coherent basis for claiming that RWC’s MMR or Varivax
vaccinations caused any of his fevers, or that RWC suffered an autistic regression as a result of
his vaccinations.
13
1. Dr. Lopez has not substantiated his assertion that RWC suffered a fever caused
by his MMR or Varivax vaccinations
In his initial report, Dr. Lopez was entirely vague about the timing of the alleged
symptom-provoking fever or fevers, stating only that his opinion was supported by fever
episodes which occurred “shortly” after the vaccinations. (Ex. 51, p. 2.) In a supplemental
report, having been specifically asked to identify the time when the febrile episodes at issue had
occurred, Dr. Lopez stated “approximately two weeks” after the vaccinations in question. (Ex.
53, p. 2.) Only after respondent’s expert, Dr. Korson, contended in his report that the first
documented fever (which occurred in late December more than a month following the
vaccination) was too remote to be linked to the November 14 vaccinations (Ex A, p. 5), did
Dr. Lopez later submit a second supplemental report indicating for the first time that his cause-
in-fact opinion was based on the fact that “Ms. Coombs told me that [RWC] developed a fever
the same day his vaccines were given on 14 NOV 2005” 8 (Ex. 55, p. 3).
At the evidentiary hearing, Dr. Lopez asserted that the expected timeframe for developing
a fever after an MMR vaccination would be “one, two or three days at most.” (Tr. 116.)
Dr. Lopez offered that a fever may occur “sometimes the same afternoon or the following
morning.” (Id.) Asked how far out one can go and attribute a fever to a vaccine, Dr. Lopez
responded that “I think that after the fourth, fifth day probably it’s unlikely that the vaccine gave
the patient a fever probably.” (Tr. 116-17.) On cross-examination, however, Dr. Lopez’s
attention was drawn to a Centers for Disease Control (CDC) “MMR Vaccine Information Sheet”
attached to his own second supplemental report in the Coombs case. (Tr. 117.) That MMR
information sheet indicates that if problems such as fever occur, “it is usually within 7-12 days
after the shot.” (Ex. 55, p. 6.) Initially Dr. Lopez refused to disagree with the statement made in
the vaccine information sheet, but when specifically asked about the contradiction between his
prior testimony and his reliance on the MMR information sheet, Dr. Lopez stated that “I know
that they put this here, but usually what I have seen in my years, the fever usually happens
shortly after the vaccine, not two weeks after.” (Tr. 119.)
8
Petitioners devote much attention in their post-hearing brief to the question of whether or
not Ms. Coombs’s testimony regarding the November 14 fever is to be believed. (ECF No. 71,
pp.11-12; ECF No. 77, pp. 4-5.) For the reasons discussed in this section, resolution of that
question is not necessary to the conclusion I have reached. Nonetheless, it is worth noting that
Dr. Lopez’s ultimate opinion in this case appears to be predicated entirely on attributing the fever
that RWC allegedly suffered on November 14, 2005, to the administration of RWC’s MMR and
Varivax vaccinations. Dr. Lopez agreed not only that RWC’s first documented fever occurred on
December 18, 2005 (Tr. 135), but also that the December 18 fever was too remote in time to
have been caused by RWC’s November 14 vaccinations (Tr. 120). And although Ms. Coombs
offered testimony indicating that she believed that RWC experienced another fever around
December 6 or 8 (Tr. 24), Dr. Lopez did not specifically acknowledge that fever in his reports or
testimony, and at no point linked it in any way to RWC’s vaccinations. In any event, a fever
occurring at about that time (Dec. 6-8) would not be attributable to RWC’s November 14
vaccinations according to Dr. Lopez’s own testimony, discussed further below, indicating that
after five days a fever could not be readily attributable to a prior vaccination. (Tr. 116-17.)
14
Significantly, the timeframe indicated by the MMR information sheet is consistent with
Dr. Lopez’s first supplemental report, but in conflict with his second supplemental report and
hearing testimony. That is, in his first supplemental report, Dr. Lopez asserted that RWC’s
initial fever, which he believed at that point to have occurred two weeks following the November
14 vaccinations, was attributable to those vaccinations. (Ex 53.) At the hearing, however, after
he had clarified with Ms. Coombs his understanding of the timing of RWC’s initial fever (Tr.
120-21), he directly contradicted that earlier opinion and testified that a fever cannot be
attributed to a vaccine after about five days. (Tr. 116-17.) Despite the contradiction, Dr. Lopez
confusingly testified that he stands by all three of his reports. (Tr. 115.)
Thus, on this critical question, Dr. Lopez has offered self-contradictory testimony at odds
with his own prior reports. He offered no explanation for his change of opinion as to whether an
MMR-caused fever should take one day or two weeks to develop, and he has failed to explain or
substantiate his ultimate opinion that vaccines can cause a fever within twenty-four hours, other
than by unspecified anecdotal instances allegedly having occurred in his own practice. Under
these circumstances, Dr. Lopez’s opinion on this subject simply cannot be credited. 9 See, e.g.
Knudson v. HHS, 35 F.3d 543, 548 (Fed. Cir. 1994)(holding that under the Vaccine Act, the
“’logical sequence of cause and effect’ must be supported by a sound and reliable medical or
scientific explanation”); see also Caves v. HHS, 100 Fed. Cl. 119, 134 (2011), aff’d 463 F.
App’x 932 (Fed. Cir. 2012)(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997) for the
9
In contrast to Dr. Lopez’ views, respondent’s expert, Dr. Wiznitzer, did describe the basis
for his expert opinion that the one-to-two week period reflected in the MMR vaccination
information sheet is accurate. (Tr. 217.) Dr. Wiznitzer persuasively explained that “the way that
the vaccine promotes the production of protective antibodies is by the viruses replicating, but in a
controlled fashion, and therefore provoking an immune response.” (Tr. 216.) Based on this
process, and comparing it to the incubation period when someone contracts the wild measles
virus, he contended that it is “biologically impossible” for an attenuated virus vaccine to create a
fever within one day. (Id.) Thus, Dr. Wiznitzer testified that if RWC experienced a fever on or
about November 14, 2005, it more likely than not would have been caused by something other
than the vaccination. (Tr. 217.) In addition, respondent’s other expert, Dr. Korson, cast further
doubt on Dr. Lopez’s reliance on a fever on November 14, 2005, as an event triggering an onset
of mitochondrial disorder symptoms. Dr. Korson testified that aggravation of any underlying
mitochondrial disorder would involve weeks of “profound” fatigue “as if their system is down
for several weeks until they slowly recover.” (Tr. 185.) Noting that RWC’s medical records for
his physician visit of December 1, 2005, characterized him as “healthy appearing, happy and
extremely active,” Dr. Korson testified that this notation is not consistent with what he would
expect if RWC had experienced aggravation of a mitochondrial disorder through a febrile
episode two weeks earlier. (Tr. 186.) Significantly, Dr. Korson attributes RWC’s first
documented fever of December 18 to an upper respiratory infection (Ex A, p. 5) which
Dr. Lopez agrees could cause exactly the kind of metabolic stress condition he asserts caused
RWC’s autistic regression, testifying that “a fever is a fever” in terms of its ability to unmask an
underlying mitochondrial disorder. (Tr. 135.) Thus, even assuming that the fever did occur on
November 14, I would still find Respondent’s experts far more convincing on the question of
whether that fever could be linked to RWC’s vaccinations.
15
proposition that “Daubert does not require a trial court ‘to admit opinion evidence that is
connected to existing data only by the ipse dixit of the expert.’”).
2. Dr. Lopez has not substantiated his assertion that RWC suffered an autistic
regression following his MMR and varivax vaccinations
Dr. Lopez testified that he could not say what RWC’s first ASD symptom was (Tr. 123),
but he acknowledged that RWC exhibited oral and texture aversion as a symptom of his ASD,
symptoms which predated his vaccinations (Tr. 124). He also acknowledged that medical
records indicate that RWC also exhibited speech delay prior to his vaccinations. (Tr. 105-06.)
And while he attributed that speech delay to hearing problems, he acknowledged that speech
delay is a sign of ASD. (Tr. 124.) Nonetheless, Dr. Lopez seemed to assert, without coherent
explanation, that what RWC experienced prior to the vaccinations in question was not the onset
of ASD, but that instead RWC experienced developmental regression following his vaccinations
in question (Tr. 107-08); for example, he stated in his initial expert report that “this child was
developing just fine until shortly after he received his scheduled immunizations.” 10 (Ex. 51, p.
3).
Dr. Lopez could not explain when the alleged regression in development occurred
beyond noting that it was “sometime after” the vaccinations. (Tr. 125-26.) Nor could he point to
any medical records where regression was indicated. (Tr. 126.) Rather, Dr. Lopez testified that
his opinion that a regression occurred was based on Ms. Coombs’s representation to him that
“[RWC] was developing normally” prior to his vaccination. (Tr. 125.) Even taking this
statement at face value, however, it does not by itself establish that RWC experienced a
regression (i.e., a loss of developed skills) as opposed to the type of ongoing clinical onset of
autism suggested by Dr. Wiznitzer. Nor is it consistent with Dr. Lopez’s above-referenced
acknowledgment that RWC exhibited signs of autism prior to his vaccination. In fact, Dr. Lopez
indicated that prior to speaking directly with Ms. Coombs he was not sure based on the medical
records whether RWC was “normal or not before the vaccine.” (Tr. 105.)
In this regard, Ms. Coombs’s testimony that she did not closely track or document
RWC’s early developmental milestones, and could not remember them with specificity, is
significant. (Tr. 17-18, 63.) Although she stated that she did not have any reason for concern
regarding RWC’s development prior to his 16-month vaccinations (Tr. 65), Dr. Wiznitzer
explained that the signs of ASDs are “very subtle” until about 18 to 24 months of age, because
10
In contrast, Dr. Wiznitzer explained that oral and texture aversion “is a well-known
behavior described in this population and seen in infancy in children who later evolve into
autism spectrum disorders,” and stated that in light of RWC’s subsequent ASD diagnosis “it’s
obvious that that was an early manifestation of that presentation.” (Tr. 207-08.) Dr. Wiznitzer
also discussed notations in RWC’s medical records indicating that RWC could count to ten by
either age nine months or seventeen months. Such behavior, Dr. Wiznitzer indicated, “is not
normal childhood behavior. If it’s present, it implies that it’s probably repeating what other
people are saying and it does not have any true meaning to it.” (Tr. 229-30.) Dr. Wiznitzer
explained that this behavior, called “echolalic behavior,” can be considered a symptom of
autism. (Tr. 230). In fact, Dr. Wiznitzer indicated that where a child’s first words are counting
without other “good functional speech,” that is an “early marker of an ASD.” (Tr. 231.)
16
the social and communicative behaviors that ASDs impact do not really develop until that time.
Therefore, the dysfunction is not apparent prior to that time. (Tr. 210-11.) Dr. Wiznitzer stated
that it is “very difficult” to identify children with ASD at six months, and that detecting ASD at
twelve months would require the observer to be “very attuned.” (Id.) Asked whether the early
signs of ASD are subtle enough to be missed during developmental screening, Dr. Wiznitzer
responded, “the answer is clearly yes.” (Tr. 214.)
After extensive recitation of RWC’s medical history, Dr. Wiznitzer, who as described
above is much better qualified than Dr. Lopez to assess the course of RWC’s ASD onset, opined
both in his expert report and at the hearing that RWC presented a clinical course that is
“consistent with the trajectory of ASD’s presentation,” and that there is “no history in the
contemporaneous medical records of a regression in his development.” (Ex. C, p. 6; see also,
e.g., Tr. 227.)
C. Conclusion
The above deficiencies in Dr. Lopez’s testimony, particularly when compared against
Dr. Wiznitzer’s and Dr. Korson’s superior qualifications and much more detailed and coherent
explanations, leave Petitioners unable to demonstrate either that RWC experienced a fever that
was triggered by his vaccinations, or that RWC experienced a post-vaccination regression.
These deficiencies are therefore fatal to Petitioners’ claim in themselves. Nonetheless, as
detailed in the section below, I also find based on the evidence before me that Petitioners have
failed to show that it is “more probable than not” that RWC suffers an underlying mitochondrial
disorder.
VII
THE EVIDENCE DOES NOT SUPPORT A CONCLUSION THAT RWC SUFFERED
FROM A MITOCHONDRIAL DISORDER
In 2009, RWC was referred to Dr. John Shoffner of MNG Medical Neurogenics to be
tested for a possible mitochondrial disorder. (Tr. 50-51.) Dr. Shoffner conducted three types of
assessment: clinical scoring (according to the “Nijmegen Clinical Criteria for Mitochondrial
Diseases”); biochemical criteria scoring; and genetic criteria scoring. (Ex. 37, p. 2230; see also
Tr. 133.) On the whole, although he noted Complex I and Complex III deficiencies within the
biochemical test results and “isolated involvement of the central nervous system” within the
clinical scoring, Dr. Shoffner found insufficient evidence to diagnose RWC with a mitochondrial
disorder. (Ex. 37, p. 2230.) There does not appear to be any dispute as to the validity of
Dr. Shoffner’s testing. In fact, Petitioners’ expert relies on these test results in his second
supplemental report. (See Ex. 55, p. 2.) Rather, Petitioners’ position that RWC suffers from a
mitochondrial disorder is based on (1) accepting the Complex I and Complex III deficiencies
found by Dr. Shoffner as being definitive of a mitochondrial disorder diagnosis; (2) rescoring
Dr. Shoffner’s clinical assessment under the Nijmegen criteria to show a greater likelihood of a
disorder; and (3) relying on RWC’s presentation of developmental delay as a clinical sign of a
mitochondrial disorder.
17
A. Biochemical and genetic criteria scoring
With regard to biochemical criteria, Dr. Lopez indicated that his opinion that RWC
suffered a mitochondrial disorder was based on enzymology findings made by Dr. Shoffner that
RWC suffered from “Complex I and Complex III mitochondrial deficiencies.” (Tr. 111-12.) To
be sure, it is not disputed in this case that Dr. Shoffner found Complex I and Complex III
deficiencies in RWC’s enzymology, and that Dr. Goldstein continued to treat RWC as
potentially suffering from mitochondrial dysfunction. (See, e.g., ECF No. 74, pp. 9-10.)
Dr. Korson, however, explained that the discovery of the Complex I and Complex III
enzymology deficiency is a “finding,” and not a “diagnosis.” (Tr. 177.)
According to Dr. Korson, the Complex I and Complex III deficiencies would have
qualified as a diagnosis of a mitochondrial disorder back in the 1990’s, but since that time
scientists have discovered that there can be “any number of reasons” not related to the
mitochondria for decreases in enzymology. (Tr. 182.) Thus, these deficiencies do not indicate
that the mitochondria are “diseased, per se.” (Id.) In this regard, despite these findings of
Complex I and Complex III deficiencies, Dr. Korson and Dr. Shoffner both agreed that it was
unlikely that RWC had a mitochondrial disorder. (See Ex. 37, p. 2230; see also Tr. 158.) In fact,
Dr. Shoffner stated in his report that “I am NOT convinced that this patient has a mitochondrial
disease. A single abnormality (abnormal enzymology) is not sufficient criteria for definitive
diagnosis.” 11 (Ex. 37, p. 2230 (emphasis in original).)
Dr. Korson further noted that enzymology findings can vary from lab to lab depending on
the methodologies used, and indicated that the Complex I is the “most unstable” and subject to
showing abnormal results due to testing errors. (Tr. 177.) For this reason, Dr. Korson explained,
enzymology results are no longer relied on as “the key factor in making a diagnosis” of
mitochondrial disorder. (Tr. 182.) Rather, genetic testing is done to look for abnormalities that
are normally associated with Complex I and Complex III deficiencies where mitochondrial
disease is present. (Tr. 177, 182.) At the time of Dr. Shoffner’s report, the genetic tests remained
11
Petitioners argue, in effect, that it is a mistake to give any weight to Dr. Shoffner’s
assessment. (ECF No. 71, p. 13 (stating that Respondent’s reliance on Dr. Shoffner’s diagnoses
is “misguided”).) I disagree. Petitioners stress that Dr. Schoffner’s opinion was not intended as
a final conclusion, that additional testing was called for, and that Dr. Shoffner never actually
definitively ruled out a mitochondrial disorder. (ECF No. 71, p. 13.) Respondent’s expert,
Dr. Korson pointed out, however, that the subsequent testing confirmed Dr. Shoffner’s
skepticism. (Tr. 195-96.) In any event, even if Dr. Shoffner offered only a preliminary
conclusion, this is no reason to discount his underlying clinical impressions. Petitioners also urge
that Dr. Goldstein’s continued treatment of RWC for a mitochondrial disorder following
Dr. Shoffner’s testing is “quite compelling” evidence that RWC did in fact suffer from such a
disorder. (ECF No. 71, pp. 12-13.) However, to the extent that this may appear to represent a
disagreement among the original clinicians, I note that Dr. Goldstein’s referral of RWC to
Dr. Shoffner for diagnosis was itself an act of deference to Dr. Shoffner’s expertise in that area
in the first place. I also note that Dr. Shoffner’s opinion is persuasively supported by
Dr. Korson’s own reasoning. Dr. Korson, as described in Section VI(A)(2) of this Decision, is
very well qualified in the diagnosis of mitochondrial disorders.
18
pending. (Ex. 37, p. 2230.) However, these tests later came back negative for these types of
abnormality. (Ex. 44, pp. 10-14; Tr. 182.)
Therefore, the biochemical and genetic criteria do not appear to support a diagnosis of
mitochondrial disorder. Although Dr. Shoffner listed such a diagnosis as “possible” under
biochemical scoring based on the Complex I and Complex III deficiencies, he urged that “a
definitive diagnosis is not made with a single abnormality.” (Ex. 37, p. 2230.) Moreover, at the
time of that writing, Dr, Shoffner did not have the benefit of the pending genetic tests. These
tests, which Dr. Korson indicated were critical to confirming the significance of the biochemical
results, came back negative. Thus, under these circumstances, the Complex I and Complex III
findings alone do not appear to be sufficient to diagnose RWC with a mitochondrial disorder.
B. Clinical criteria scoring
In terms of clinical criteria, Dr. Shoffner scored RWC based on the “Nijmegen criteria,” a
compilation of various tests results and clinical observations used to determine whether sufficient
signs of mitochondrial disorder exist. (Ex. 37, p. 2230.) Dr. Shoffner scored a single “point” for
RWC out of a possible twelve, meaning that a mitochondrial disorder is “unlikely.” (Id.) In his
expert report Dr. Korson indicated his agreement with Dr. Shoffner’s assessment under the
Nijmegen criteria. (Ex. A, p. 4.) Based on his review, Dr. Lopez testified that he would re-score
RWC as a six, meaning mitochondrial disorder is “probable.” (Tr. 145-46.) Dr. Lopez’s
testimony on this issue is problematic in several regards, however, and, as a result, I do not find
it credible.
First, I find that Dr. Lopez’s re-scoring of the Nijmegen criteria is, at least in part,
speculative. For example, Dr. Lopez agreed with Petitioners’ counsel that he would add two
points to RWC’s Nijmegen score for having an abnormal resting metabolic rate. (Tr. 144-45.)
Dr. Lopez reached this conclusion, he states, because his review of RWC’s medical records led
him to expect RWC to have an abnormal exercise study. (Tr. 145.) Dr. Korson indicated,
however, that such exercise studies are generally not used for patients younger than about ten
years old (Tr. 168), and Dr. Lopez admitted that no such exercise study was done in RWC’s case
(Tr. 144-45). In this regard even Dr. Lopez characterized his own scoring as “speculative.” (Tr.
144-45).
Second, to the extent Dr. Lopez’s re-scoring is in conflict with the assessment Dr.
Shoffner recorded in the medical records, I believe Shoffner’s contemporaneous clinical
impression is deserving of greater weight. That is, Dr. Lopez has not convinced me of any error
made by Dr. Shoffner in his assessment. For example, Dr. Lopez cites Dr. Shoffner’s finding
that RWC had a low carnitine level as supporting a diagnosis of mitochondrial disorder. (Ex. 55,
p. 2.) Dr. Shoffner, however, appears to have discounted this possibility, noting instead that the
low carnitine level is “likely of dietary origin.” (Ex. 37, p. 2228.)
Dr. Korson explained that the most common sources of carnitine are red meat, milk, and
dairy products, and, therefore, dietary issues are the most common cause of a low carnitine level.
(Tr. 174.) Additionally, Dr. Korson noted that the ratio of free carnitine to total carnitine is an
important indicator, and that RWC’s ratio suggested dietary deficiency rather than metabolic
disorder. (Tr. 174-75.) Dr. Korson’s explanation of Dr. Shoffner’s decision to discount the low
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carnitine level is supported by the medical records. The lab report prepared for Dr. Shoffner in
RWC’s case indicated a normal ratio and a likely dietary deficiency. (Ex. 37, p. 2208.) Dr.
Lopez, on the other hand, testified that he did not know what the most common cause of low
carnitine was, or why Dr. Shoffner concluded that RWC’s low carnitine was of dietary origin.
(Tr. 151.)
Finally, Dr. Lopez has no prior clinical experience applying the Nijmegen criteria, while
Dr. Shoffner’s assessment is affirmed by Dr. Korson, who, in addition to being well-qualified in
this area, has prior clinical experience applying the Nijmegen test criteria in particular. This
lends greater weight to Dr. Korson’s assessment of the Nijmegen factors. For example, Dr.
Lopez reached his conclusion in part by adding two points onto Dr. Shoffner’s scoring of the
Nijmegen scale, because RWC’s tests revealed an elevated lactate level. (Tr. 144.) Dr. Korson
explained, however, that lactate can be elevated for a number of reasons, the most common of
which is an error in processing the test. (Tr. 169-70, 179, 189-90.) For this reason, Dr. Korson
indicated that in order to find that lactate is “truly” elevated, it is necessary to confirm an
elevated lactate level by also finding elevated alanine and organic acids. (Tr. 170-71, 173, 189-
90.) Because there was no elevated alanine or organic acid in this case, Dr. Korson believed that
Dr. Shoffner was correct to discount the finding of elevated lactate in RWC’s case. (Tr. 189-90.)
Dr. Lopez, however, appeared to be unaware of this method of confirmation. (Tr. 151.)
C. RWC’s developmental delay as a clinical presentation of mitochondrial disorder
Dr. Lopez relies on RWC’s developmental delay as primary evidence of RWC’s clinical
presentation of mitochondrial disorder, arguing that it is evidence that the mitochondrial disorder
has impacted his brain. (Tr. 127-28.) And, to be sure, Dr. Korson acknowledged that RWC’s
developmental delay was the basis for the one point that Dr. Schoffner did score on RWC’s
Nijmegen assessment. (Tr. 178). Dr. Lopez acknowledged, however, that although he believed
RWC’s developmental delay was “consistent” with mitochondrial disorder, it could also be
explained as part of his autism. (Tr. 128) That is, Dr. Lopez admitted that someone could have
the same symptoms as RWC and not have a mitochondrial disorder. (Id.)
Dr. Korson, on the other hand, though he acknowledged RWC’s ASD diagnosis,
indicated that in terms of being evidence of a mitochondrial disorder, it is “not a very specific
finding,” because “any kind of developmental issue has been described with mitochondrial
disease.” (Tr. 183.) Dr. Korson indicated that there is no “specific presentation” for a patient
with Complex I or Complex III deficiencies, but based on his review of the records, Dr. Korson
did not believe that RWC had any features associated with energy issues. (Id.) Dr. Korson
indicated that “an isolated brain problem” without “other organ systems involved” would be
unusual. (Tr. 180.)
D. Conclusion
On the whole Dr. Lopez has failed to convince me that his re-scoring of Dr. Shoffner’s
clinical assessment is either sufficiently grounded in RWC’s medical history, or more accurate
than Dr. Shoffner’s original assessment. Absent that re-scoring, he has also failed to
demonstrate that RWC’s ASD on its own is a sufficient clinical marker of a mitochondrial
disease. Additionally, Complex I and Complex III deficiencies without genetic confirmation
20
likewise do not appear to be an adequate marker of a mitochondrial disorder where the clinical
picture is otherwise lacking. For these reasons, I find that Petitioners have failed to demonstrate
that it is “more probable than not” that RWC suffered an underlying mitochondrial disorder.
VIII
PETITIONERS’ CASE FAILS THE ALTHEN TEST
As noted above, in its ruling in Althen, the U.S. Court of Appeals for the Federal Circuit
discussed the “causation-in-fact” issue in Vaccine Act cases. The court stated as follows:
Concisely stated, Althen’s burden is to show by preponderant evidence that the
vaccination brought about her 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 the vaccination and injury.
If Althen satisfies this burden, she is “entitled to recover unless the [government]
shows, also by a preponderance of the evidence, that the injury was in fact caused
by factors unrelated to the vaccine.”
Althen, 418 F.3d 1274, 1278 (Fed. Cir. 2005)(citations omitted). In the pages above, of course, I
have already set forth in detail my analysis in rejecting Petitioners’ “causation-in-fact” theory in
this case. In this part of my Decision, then, I will briefly explain how that analysis fits
specifically within the three parts of the Althen test, enumerated in the first sentence of the
Althen excerpt set forth above. The short answer is that I find that Petitioners’ theory in this case
clearly does not satisfy the Althen test.
A. Relationship between Althen Prongs 1 and 2
One interpretive issue with the Althen test concerns the relationship between the first two
elements of that test. The first two prongs of the Althen test, as noted above, are that the
petitioners must provide “(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.” Initially, it is not absolutely clear how the two prongs differ from each other. That
is, on their faces, each of the two prongs seems to require a demonstration of a “causal”
connection between the “vaccination” and “the injury.” However, a number of Program
opinions have concluded that these first two elements reflect the analytical distinction that has
been described as the “can cause” vs. “did cause” distinction. That is, in many Program opinions
issued prior to Althen involving “causation-in-fact” issues, special masters or judges stated that a
petitioner must demonstrate (1) that the type of vaccination in question can cause the type of
injury in question, and also (2) that the particular vaccination received by the specific vaccine
did cause the vaccinee’s own injury. See, e.g., Kuperus v. HHS, 2003 WL 22912885, at *8 (Fed.
Cl. Spec. Mstr. Oct. 23, 2003); Helms v. HHS, 2002 WL 31441212, at *18 n. 42 (Fed. Cl. Spec.
Mstr. Aug. 8, 2002). Thus, a number of judges and special masters of this court have concluded
that Prong 1 of Althen is the “can cause” requirement, and Prong 2 of Althen is the “did cause”
requirement. See, e.g., Doe 11 v. HHS, 83 Fed. Cl. 157, 172-73 (2008); Nussman v. HHS, 83
Fed. Cl. 111, 117 (2008); Banks v. HHS, 2007 WL 2296047, at *24 (Fed. Cl. Spec. Mstr. July
21
20, 2007); Zeller v. HHS, 2008 WL 3845155, at *25 (Fed. Cl. Spec. Mstr. July 30, 2008). And,
most importantly, the Federal Circuit confirmed that interpretation in Pafford, ruling explicitly
that the “can it?/did it?” test, used by the special master in that case, was equivalent to the first
two prongs of the Althen test. Pafford v. HHS, 451 F.3d at 1352, 1355-56 (Fed. Cir. 2006).
Thus, interpreting the first two prongs of Althen as specified in Pafford, under Prong 1 of Althen
a petitioner must demonstrate that the type of vaccination in question can cause the type of
condition in question; and under Prong 2 of Althen that petitioner must then demonstrate that the
particular vaccination did cause the particular condition of the vaccinee in question.
Moreover, there can be no doubt whatsoever that the Althen test ultimately requires that,
as an overall matter, a petitioner must demonstrate that it is “more probable than not” that the
particular vaccine was a substantial contributing factor in causing the particular injury in
question. That is clear from the statute itself, which states that the elements of a petitioner’s case
must be established by a “preponderance of the evidence.” § 300aa-13(a)(1)(A). And, whatever
is the precise meaning of Prongs 1 and 2 of Althen, in this case the overall evidence falls far short
of demonstrating that it is “more probable than not” that any of the vaccines that RWC received
contributed to the causation of RWC’s tragic neurodevelopmental disorder.
B. Petitioners have established Prong 1 of Althen in this case
As explained above, under Prong 1 of Althen a petitioner must provide a medical theory
demonstrating that the type of vaccine in question can cause the type of condition in question.
Petitioner’s theory is that a fever caused by RWC’s MMR and/or Varivax vaccinations provoked
an autistic regression, by unmasking an underlying mitochondrial disorder. In this case,
Respondent’s expert agreed that a fever is capable of aggravating an underlying mitochondrial
disorder and causing autistic regression. (See, e.g., Tr. 239-40.) At least for the purposes of this
case, then, it would seem that Petitioners have satisfied the first Althen prong--i.e., the evidence
in this case preponderates in favor of the theory that a fever is capable of aggravating an
underlying mitochondrial disorder, thereby causing an autistic regression. 12
C. Petitioners have failed to establish Prong 2 of Althen in this case
Under Prong 2, the Petitioners need to show that it is “more probable than not” that one
of RWC’s vaccinations did cause RWC’s own severe neurodevelopmental disorder. But this
they have failed to do, for all of the reasons detailed above. Again, Petitioners’ theory is that a
fever caused by RWC’s MMR and/or Varivax vaccinations provoked an autistic regression by
unmasking an underlying mitochondrial disorder. Yet Petitioners have failed to persuasively
establish that any of RWC’s fevers could be attributed to his vaccinations (see Section VI (B)(1)
12
It is worth noting, however, that Dr. Lopez acknowledged at the hearing that in order for this
theory to apply in this case, RWC must have had an underlying mitochondrial disorder and
experienced a fever caused by his MMR and/or Varivax vaccinations. (Tr. 116). Because, as
discussed in Section VIII (C) of this Decision below, I find that these factual predicates have not
been established in this case, the medical theory advanced by Petitioners, even if undisputed,
remains a complete mismatch to the record of this case. Therefore, satisfaction of the first Althen
prong in this case is effectively rendered academic, since Petitioners failed, as explained above,
to establish Prongs 2 and 3 of the Althen test.
22
above); that he experienced any autistic regression at all (see Section VI(B)(2) above); or that he
actually had an underlying mitochondrial disorder (see Section VII above). Thus, Petitioners
have failed to establish Prong 2 of Althen in this case. 13
D. Petitioners have failed to establish Prong 3 of Althen in this case
Since I have explained why Petitioners have failed to satisfy the second prong of Althen, I
need not discuss why Petitioners’ case also fails to satisfy the third prong. However, I will note
again Dr. Lopez’s inability to coherently identify a time period during which a fever can be
attributed to a vaccination; his inability to identify the timeframe during which the alleged
autistic regression occurred; and his admission that RWC exhibited symptoms of autism prior to
his vaccinations. These deficiencies in Dr. Lopez’s testimony would preclude any finding of a
proximate temporal relationship between the vaccination and the injury, as required under Althen
Prong 3.
E. This is not a close case
As noted above, in Althen the Federal Circuit indicated that the Vaccine Act involves a
“system created by Congress, in which close calls regarding causation are resolved in favor of
injured claimants.” 418 F.3d at 1280. Accordingly, I note here that this case ultimately is not a
close case. For all the reasons set forth above, I found that Dr. Lopez’s theory was not at all
persuasive, while Respondent’s experts were far more persuasive.
IX
CONCLUSION
The record of this case demonstrates plainly that RWC and his family have been through
a tragic ordeal. I had the opportunity, in the courtroom during the evidentiary hearing, to meet
and observe RWC’s mother. I have also studied the records describing RWC’s medical history,
and the efforts of his family in caring for him. Based upon those experiences, the great
dedication of RWC’s family to his welfare is readily apparent to me.
Nor do I doubt that RWC’s parents are sincere in their belief that vaccines played a role
in causing RWC’s autism. RWC’s parents have heard the opinion of Dr. Lopez, and likely other
physicians who profess to believe in a causal connection between vaccines and autism. After
studying the extensive evidence in this case, I am convinced that the opinions provided by the
petitioners’ expert in this case, advising the Coombs family that there is a causal connection
between vaccines and RWC’s autism, have been quite wrong. Nevertheless, I can understand
why RWC’s parents found such opinions to be believable under the circumstances. I conclude
that the Petitioners filed this Program claim in good faith.
13
To clarify, Petitioners have failed to show that RWC’s autism was either initially caused
by his vaccinations, or was aggravated in any way by his vaccinations.
23
Thus, I feel deep sympathy for the Coombs family. Further, I find it unfortunate that my
ruling in this case means that the Program will not be able to provide funds to assist this family,
in caring for their child who suffers from a serious disorder. It is my view that our society does
not provide enough assistance to the families of all autistic children, regardless of the cause of
their disorders. And it is certainly my hope that our society will find ways to ensure that in the
future much more generous assistance is available to all such children. Such families must cope
every day with tremendous challenges in caring for their autistic children, and all are deserving
of sympathy and admiration. However, I must decide this case not on sentiment, but by
analyzing the evidence. Congress designed the Program to compensate only the families of
those individuals whose injuries or deaths can be linked causally, either by a Table Injury
presumption or by a preponderance of “causation-in-fact” evidence, to a listed vaccine. In this
case, the evidence advanced by the petitioners has fallen far short of demonstrating such a link.
Accordingly, I conclude that the petitioners in this case are not entitled to a Program award on
RWC’s behalf. 14
/s/ George L. Hastings, Jr.
George L. Hastings, Jr.
Special Master
14
In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court
shall enter judgment accordingly.
24