Court Opinion

ID: 2658322
Source: CourtListenerOpinion
Date Created: 2014-03-28 18:16:13.388792+00
Date Added: 2024-06-11T11:59:56.937553
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
                ______________________

          CYNTHIA LALONDE, parent of,
                M.L., a minor,
              Petitioner-Appellant,

                           v.

      SECRETARY OF HEALTH AND HUMAN
                  SERVICES,
              Respondent-Appellee.
             ______________________

                      2013-5088
                ______________________

    Appeal from the United States Court of Federal
Claims in No. 06-VV-0435, Judge Margaret M. Sweeney.
                 ______________________

               Decided: March 28, 2014
               ______________________

   CURTIS R. WEBB, Law Office of Curtis R. Webb, of
Twin Falls, Idaho, argued for petitioner-appellant.

    LINDA S. RENZI, Senior Trial Counsel, Torts Branch,
Civil Division, United States Department of Justice, of
Washington, DC, argued for respondent-appellee. With
her on the brief were STUART F. DELERY, Assistant Attor-
ney General, RUPA BHATTACHARYYA, Director, VINCENT J.
MATANOSKI, Deputy Director, and VORIS E. JOHNSON, JR.,
Assistant Director.
                 ______________________
2                                            LALONDE   v. HHS

    Before NEWMAN, PROST, and TARANTO, Circuit Judges.
     Opinion for the court filed by Circuit Judge PROST.
     Dissenting opinion filed by Circuit Judge NEWMAN.
PROST, Circuit Judge.
    This case, brought under the National Childhood Vac-
cine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34, as
amended (the “Vaccine Act”), presents the question
whether petitioner Cynthia LaLonde, on behalf of her son
M.L., has proven by a preponderance of the evidence that
M.L.’s diphtheria-tetanus-acellular pertussis (“DTaP”)
vaccination caused a focal brain injury. The special
master found that although M.L.’s DTaP vaccination
likely caused his initial anaphylactic reaction, Ms.
LaLonde failed to establish under any reliable medical
theory that M.L.’s anaphylaxis caused a focal brain inju-
ry. See LaLonde v. Sec’y of Health & Human Servs., No.
06-435V, 2012 WL 5351164 (Fed. Cl. Spec. Mstr. Sept. 28,
2012). After a careful consideration of the record, the U.S.
Court of Federal Claims upheld that finding.             See
LaLonde v. Sec’y of Health & Human Servs., 110 Fed. Cl.
184 (2013). We affirm.
                      I. BACKGROUND
    The relevant facts are primarily those found by the
special master in his detailed September 28, 2012 deci-
sion. See LaLonde, 2012 WL 5351164, at *3-6. M.L. was
born on September 24, 2003. At his fifteen-month well-
child visit, his pediatrician noted that M.L. was walking
and generally developing normally but did not “want to
talk.” On April 14, 2005, M.L. received several immun-
izations, including the DTaP vaccination. About five
hours later, M.L. allegedly began experiencing an abnor-
mally high fever and some swelling. The next day M.L.
was admitted to the hospital with a diagnosis of “vaccine
adverse reaction with secondary fever, angiodema, and
anaphylactoid reaction.” J.A. 20. He was discharged on
LALONDE   v. HHS                                          3

April 16, 2005. However, the following morning M.L.’s
mother called an ambulance because M.L. was exhibiting
signs of hypothermia and seizure-like episodes.
    In the weeks and months following the administration
of the DTaP vaccination, M.L.’s vocabulary allegedly
decreased, worrying his parents and his doctors. An MRI
of M.L.’s brain with and without contrast was normal,
revealing a deep bilateral middle ear infection but no
brain damage. Nonetheless, M.L. continued to exhibit
several “seizure-like” activities, but after a few months he
was weaned off anti-epileptic medication. After observing
M.L.’s developmental delays and repetitive behaviors, a
pediatric neurologist placed M.L. in the autism spectrum
disorder category.
                   II. PROCEDURAL HISTORY
    Ms. LaLonde filed a petition under the Vaccine Act on
June 1, 2006, seeking compensation for M.L.’s alleged
injuries. The case was assigned to a special master, who
heard expert testimony from Dr. Marcel Kinsbourne for
Ms. LaLonde. Dr. Kinsbourne testified that M.L. experi-
enced a two-phase anaphylactic reaction that included a
delayed second state. He pointed to medical literature
that supports the existence of late-phase anaphylactic
reactions and offered three possible mechanisms of injury
that have been shown in medical literature to result from
an anaphylactic reaction. However, Dr. Kinsbourne was
unable to point to anywhere in the literature that de-
scribes the sequence of events that are presented in this
case. Dr. Kinsbourne also admitted that he lacked any
reliable medical evidence supporting the notion that
anaphylactic shock can cause focal brain injuries.
    After reviewing the evidence in the case, the special
master saw what he called a “major gap” in Ms.
LaLonde’s case. LaLonde, 2012 WL 5351164, at *1. He
alerted Ms. LaLonde to this fact and allowed her to sub-
mit new evidence, updated medical records, and a revised
4                                           LALONDE   v. HHS

expert report. Id. at *2. Nonetheless, after re-reviewing
the entire record, the special master found two decisive
defects in Ms. LaLonde’s case: (1) Dr. Kinsbourne’s opin-
ions were based on information provided by Ms. LaLonde
and not on medical information found in the record; and
(2) the record indicated—and all experts agreed—that
M.L.’s initial reaction to the immunizations resolved, and
Dr. Kinsbourne’s theory that there was a secondary,
delayed anaphylactic reaction was unsupported by the
record. Id. at *3.
    On review, the Court of Federal Claims concluded
that the special master abused his discretion by discredit-
ing Dr. Kinsbourne’s opinions that were based on state-
ments made by Ms. LaLonde, even if some of her
statements were in conflict with the medical records.
LaLonde, 110 Fed. Cl. at 204. Nonetheless, the Court of
Federal Claims concluded that this abuse of discretion
was “harmless.” Id. It explained that the special master
“quite properly required [Ms. LaLonde] to carry her
burden to bring forward a reliable medical or scientific
explanation,” and she failed to do so. Id. at 201. Her
expert, Dr. Kinsbourne, testified that he had never seen
an anaphylactic reaction lead to a focal brain injury, he
did not find any support for a link in the medical litera-
ture, and he had an incomplete understanding of how the
reaction could evolve into a focal brain injury. Id.
    We have jurisdiction to review the final judgment of
the Court of Federal Claims under 42 U.S.C. § 300aa-
12(f).
                  III. THE VACCINE ACT
    In 1986, Congress passed the Vaccine Act to establish
a program administered by the Secretary of Health and
Human Services to increase the safety and availability of
vaccines. See 42 U.S.C. § 300aa-1; Terran v. Sec’y of
Health & Human Servs., 195 F.3d 1302, 1307 (Fed. Cir.
1999). The Vaccine Act created the National Vaccine
LALONDE   v. HHS                                           5

Injury Compensation Program, through which claimants
could petition to receive compensation for vaccine-related
injuries or death. See 42 U.S.C. § 300aa-10(a).
    To receive compensation, a claimant must show, by a
preponderance of the evidence, that the vaccinated person
received a covered vaccine and either: (1) suffered an
injury, condition, or a significant aggravation of a pre-
existing injury or condition listed on the Table within the
requisite time frame, in which case causation is presumed
(a “Table injury”); or (2) suffered an injury or condition or
suffered the significant aggravation of a pre-existing
injury or condition not on the Table, in which case causa-
tion must be proven (a “non-Table injury”). See 42 U.S.C.
§§ 300aa-11(c)(1)(C), 300aa-14; 42 C.F.R. § 100.3 (2011).
To prove actual causation in a non-Table injury case, the
petitioner must
    show by preponderant evidence that the vaccina-
    tion brought about [the] injury by providing: (1) a
    medical theory causally connecting the vaccina-
    tion 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 prox-
    imate temporal relationship between the vaccina-
    tion and the injury.
Moberly ex rel. Moberly v. Sec’y of Health & Human
Servs., 592 F.3d 1315, 1322 (quoting Althen v. Sec’y of
Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir.
2005)). If the petitioner satisfies this burden, she is
“entitled to recover unless the [government] shows, also
by a preponderance of evidence, that the injury was in
fact caused by factors unrelated to the vaccine.” Althen,
418 F.3d at 1278 (quoting Knudsen v. Sec’y of Health &
Human Servs., 35 F.3d 543, 547 (Fed. Cir. 1994)) (altera-
tion in original). The petitioner is not required to prove
the case to a level of scientific certainty. Rather, the
burden of showing something by a preponderance of the
6                                           LALONDE   v. HHS

evidence, the most common standard in the civil law,
simply requires the trier of fact to believe that the exist-
ence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the
burden to persuade the [judge] of the fact’s existence.
Moberly, 592 F.3d at 1322 n.2 (quoting Concrete Pipe &
Prods. of Cal., Inc. v. Constr. Laborers Pension Trust for
S. Cal., 508 U.S. 602, 622 (1993)).
                IV. STANDARD OF REVIEW
    In Vaccine Act cases, we review a ruling by the Court
of Federal Claims de novo, applying the same standard
that it applies in reviewing the decision of the special
master. Moberly, 592 F.3d at 1321 (Fed. Cir. 2010) (citing
Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357,
1360 (Fed. Cir. 2000)). We review factual findings under
the arbitrary and capricious standard, and we review
legal rulings to determine whether they are “not in ac-
cordance with law.” Id. (citing Munn v. Sec’y of Health &
Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992)).
                      V. DISCUSSION
    On appeal, Ms. LaLonde argues that the special mas-
ter made a legal error when he denied her claim for
compensation. Relying on Knudsen v. Secretary of Health
and Human Services, 35 F.3d 543 (Fed. Cir. 1994), she
claims that the special master used an incorrect legal
standard when he required Ms. LaLonde to prove the
mechanism through which the initial anaphylactic reac-
tion caused M.L. to later suffer focal brain injuries. She
argues that although Dr. Kinsbourne had proposed three
potential mechanisms, the special master discredited him
due to his failure to specify which caused M.L.’s injury.
    Additionally, Ms. LaLonde acknowledges that under
our case law, a temporal relationship alone between a
vaccination and injury would not logically support a
causal relationship. Moberly, 592 F.3d at 1323. But she
LALONDE   v. HHS                                        7

argues that “[t]here is a very significant difference be-
tween inferring causation from a proximate temporal
relationship between an anaphylactic reaction and an
injury [which is what she requests that we do], and infer-
ring causation from a proximate temporal relationship
between a vaccination and an injury,” which the law
states is not enough to receive relief under the Vaccine
Act. Pet’r’s Reply Br. 10 (emphasis added). Ms. LaLonde
claims that such a temporal association is a logical se-
quence of cause and effect; she asserts that the proximate
temporal association between an anaphylactic reaction
and a dramatic regression in speech skills suggests that
the anaphylactic reaction caused the regression in speech
skills.
    Finally, Ms. LaLonde reminds the court that the pur-
pose of the Vaccine Act’s preponderance of the evidence
standard is to “allow the finding of causation in a field
bereft of complete and direct proof of how vaccines affect
the human body.” Althen, 418 F.3d at 1280. Ms. LaLonde
also requests a remand and a new hearing so that she
may present new evidence that has come to light in the
six years since this case began.
     We have considered all of Ms. LaLonde’s arguments,
and while we are certainly sympathetic to her and her
son, M.L., we nonetheless conclude that Ms. LaLonde has
failed to meet her burden to receive her requested relief.
As Ms. LaLonde correctly states in her opening brief, “to
require identification and proof of a specific biologic
mechanism [in Vaccine Act cases] would be inconsistent
with the purpose and nature of the vaccine compensation
program.” Pet’r’s Br. 18 (quoting Knudsen, 35 F.3d at
549). However, in the past we have made clear that
simply identifying a “plausible” theory of causation is
insufficient for a petitioner to meet her burden of proof.
Moberly, 592 F.3d at 1322. Instead, the statutory stand-
ard of preponderance of the evidence requires a petitioner
to demonstrate that the vaccine more likely than not
8                                              LALONDE   v. HHS

caused the condition alleged. See id. (“[P]roof of a ‘plausi-
ble’ or ‘possible’ causal link . . . is not the statutory stand-
ard.”); see also 42 U.S.C. § 300aa-13(a)(1).
     Ms. LaLonde’s expert, Dr. Kinsbourne, hypothesized
that M.L. suffered a two-stage anaphylactic reaction—the
first phase occurring before his hospital admission on
April 15, 2005 and the second phase occurring when his
mother called for an ambulance on April 17, 2005. Alt-
hough Dr. Kinsbourne submitted medical literature
describing a two-phase anaphylactic reaction, this litera-
ture does not support his testimony that M.L. had a
reaction similar to the type the literature described with
regard to either the timing of a two-phase event or the
type of injury Ms. LaLonde alleges. Moreover, Dr. Kins-
bourne acknowledged that he had never before seen the
sequence he posited as having occurred here, and that it
was “beyond rare.” J.A. 91. And when asked to provide
support for his theory that an anaphylactic reaction could
cause a focal brain injury, Dr. Kinsbourne testified he did
not know whether his theory was generally accepted or
even discussed in the medical community. J.A. 90-91. He
further testified that he had never seen an anaphylactic
reaction lead to a focal brain injury, could not find support
for it in the medical literature, and possessed an incom-
plete understanding of how the injury could evolve into a
focal brain injury. Id.
    Thus, contrary to Ms. LaLonde’s argument, the spe-
cial master did not require Dr. Kinsbourne to provide
proof of his proposed mechanism, but instead merely
required that he support his testimony with a reputable
or scientific explanation that pertained specifically to
M.L.’s case. See Hibbard v. Sec’y of Health & Human
Servs., 698 F.3d 1355, 1365 (Fed. Cir. 2012) (requiring
petitioner to show both the medical plausibility of her
theory of causation and that the injury was consistent
with that theory). And the special master did not err in
finding that Dr. Kinsbourne failed to do so.
LALONDE   v. HHS                                         9

    In Moberly, we concluded that “the only . . . evidence
in the record providing any support for [petitioner’s]
theory of causation was the testimony of Dr. Kinsbourne,
which the special master had found to be ‘contradictory
and confusing’ and ‘shockingly poor.’” 592 F.3d at 1321.
Similarly, in that case, Dr. Kinsbourne testified that his
proposed mechanism had never been tested in any peer-
reviewed study. Id. at 1324. In affirming the finding that
Dr. Kinsbourne’s testimony was insufficient, we noted
that he “undercut his own position by conceding not only
that [his proposed theory] had never been tested, but also
that there was no evidence suggesting that it applied to
[the petitioner’s] case.” Id. at 1325. Likewise, here Dr.
Kinsbourne has proposed three mechanisms, but none are
supported in any peer-reviewed study. And there is no
evidence beyond Dr. Kinsbourne’s testimony suggesting
that any of the three proffered mechanisms applied to
M.L.’s case.
    Furthermore, as the finder of fact, the special master
was responsible for assessing the reliability of Dr. Kins-
bourne’s testimony by looking for reliable medical or
scientific support. See Moberly, 592 F.3d at 1324-25. In
doing so, the special master was “entitled—indeed, ex-
pected—to make determinations as to the reliability of the
evidence presented to [him] and, if appropriate, as to the
credibility of the persons presenting the evidence.” Id. at
1326. Regarding Dr. Kinsbourne’s testimony, the special
master stated that he found it “necessary to address the
credibility of petitioner’s expert,” and noted that the
“testimony in this case was as poor as any the under-
signed has experienced in twenty years.” LaLonde, 2012
WL 5351164, at *17.
     Additionally, it was not the government’s burden to
provide an alternative explanation. See, e.g., Althen, 418
F.3d at 1278 (stating that only after the petitioner satis-
fies her burden by preponderant evidence does the burden
shift to the government to show that the injury was in
10                                          LALONDE   v. HHS

fact caused by factors unrelated to the vaccine); 42 U.S.C.
§ 300aa-13. Nonetheless, the government’s expert wit-
ness, Dr. John MacDonald, not only contradicted Dr.
Kinsbourne’s testimony by stating that he did not believe
that M.L. had a focal brain injury as a result of an ana-
phylactic reaction but also pointed to the evidence in the
record supporting his theory that M.L.’s speech delay was
caused by a deep bilateral middle ear infection. J.A. 145,
277, 297.
    In Vaccine Act cases, petitioners must proffer trust-
worthy testimony from experts who can find support for
their theories in medical literature in order to show
causation under the preponderance of the evidence stand-
ard. The level of specificity of such support may vary
from circumstance to circumstance. But the special
master here could properly find insufficient the reliance
by Ms. LaLonde’s expert on a theory that is unsupported
by the literature to explain a sequence he had never seen
before. Given that conclusion, the basis for Ms. LaLonde’s
petition reduces to a temporal relationship between the
administration of the DTaP vaccine and M.L.’s focal brain
injuries. As we have stated before, a temporal correlation
alone is not enough to demonstrate causation. Moberly,
592 F.3d at 1323.
                     VI. CONCLUSION
    In this case, as in Moberly, the special master and the
Court of Federal Claims applied the correct legal stand-
ard and found, based in part on the unconvincing nature
of Dr. Kinsbourne’s testimony, that the petitioner failed to
prove causation by a preponderance of the evidence. That
judgment has not been shown to be legally or factually
erroneous. We therefore affirm the judgment of the Court
of Federal Claims.
                       AFFIRMED
LALONDE   v. HHS                            11

                         COSTS
   Each party shall bear their own costs.
  United States Court of Appeals
      for the Federal Circuit
                ______________________

           CYNTHIA LALONDE, parent of
                   M.L., a minor,
               Petitioners-Appellants,

                           v.

      SECRETARY OF HEALTH AND HUMAN
                  SERVICES,
              Respondent-Appellee.
             ______________________

                      2013-5088
                ______________________

    Appeal from the United States Court of Federal
Claims in No. 06-VV-0435, Judge Margaret M. Sweeney.
                 ______________________
NEWMAN, Circuit Judge, dissenting.
    On April 14, 2005 Petitioner LaLonde’s son M.L. had
an 18-month well-child visit with his pediatrician, at
which he received immunizations for varicella, DTaP
(diphtheria, tetanus-a, and pertussis), HiB (Haemophilus
influenza type B), and PCV7 (pneumococcal conjugate
vaccine). Within five hours after the vaccinations his
temperature was 104.8 degrees, accompanied by facial
swelling and vomiting. The next morning his pediatrician
sent him by ambulance to the hospital, where M.L. re-
ceived the diagnosis of “vaccine adverse reaction with
secondary fever, angioedema, and anaphylactoid reac-
tion.” The emergency doctor recorded that M.L. exhibited
tongue and lip swelling, facial redness, was unable to
2                                            LALONDE   v. HHS

swallow, was drooling and was short of breath. He was
discharged a day later, but the next day was returned to
the hospital where he experienced multiple seizure-like
episodes. He remained in the hospital for four days, as
various specialists tested body and brain. Two weeks
later, M.L.’s primary pediatrician referred M.L. to a
University Hospital Neurologist after his mother reported
that he would not speak. All of the contemporaneous
records refer to the events as a reaction to his vaccine.
     M.L.’s medical history is not disputed, that from his
birth to his 18-month well-child appointment, he ap-
peared to be a normal healthy child with an age-
appropriate vocabulary, and was reduced to mostly unin-
telligible sounds following his vaccination. The record
consistently describes “seizure disorder and language
regression” following his vaccine administration. M.L.
thereafter was seen by multiple neurologists, a develop-
mental specialist, and a speech therapist, whose reports
are in the record. A treating physician wrote in Septem-
ber 2005:
    Since the day of the shots, (M.L.) has lost the abil-
    ity to speak as he had previously. Up to that time
    he had a normal vocabulary for his age and was
    attempting to put words together such as “I
    want.” Since then, however, he is mostly able to
    utter only unintelligent sounds and occasionally
    will utter a recognizable word.
In January of 2006 a pediatric neurologist wrote that “[i]t
is puzzling that apparently his development was age
appropriate up until 18 months when he had his routine
immunization resulting in severe allergic reaction.”
    The record on this appeal does not state M.L.’s pre-
sent situation, but does refer to a drastic regression in his
development. M.L.’s medical history in the record, the
contemporaneous statements of his treating physicians
and the petitioner’s expert’s opinion establish a more-
LALONDE   v. HHS                                          3

likely-than-not causal relationship between M.L.’s vac-
cination and his resultant injuries. In the proceedings
before the Special Master and the Court of Federal
Claims, the only doctor who eliminated the vaccine as a
causative agent of the observed injuries was the govern-
ment’s expert, Dr. McDonald. However, even Dr. McDon-
ald agreed that M.L. had an adverse reaction to the
vaccine.
    Vaccine injury is rare, and the path of causation is not
well understood. Recognizing the uncertainties of immun-
ization science, the Vaccine Act establishes that when
injury occurs a claimant is not required to prove causation
as a matter of medical certainty. Thus the Vaccine Act
requires that, for non-Table injuries, liability must be
shown by a preponderance of the evidence, and that
reasonable doubt is resolved in favor of the claimant.
This standard is premised on the appreciation that a
scientific causal relationship between a vaccine and a
particular injury may be hard to prove. The court ex-
plained in Althen v. Secretary of Health & Human Ser-
vices, 418 F.3d 1274, 1280 (Fed. Cir. 2005) that “the
purpose of the Vaccine Act’s preponderance standard is to
allow the finding of causation in a field bereft of complete
and direct proof of how vaccines affect the human body.”
See also Capizzano v. Sec’y of Health & Human Servs.,
440 F.3d 1317, 1325 (Fed. Cir. 2006) (“requiring either
epidemiologic studies, rechallenge, the presence of patho-
logical markers or genetic disposition, or general ac-
ceptance in the scientific or medical communities to
establish a logical sequence of cause and effect is contrary
to what we said in Althen.”).
    Contrary to my colleagues’ ruling today, the require-
ment for specific cause-effect studies published in peer-
reviewed scientific journals, whatever the nature and
weight of the other evidence, “contravenes section 300aa–
13(a)(1)’s allowance of medical opinion as proof.” Id. As
in Althen, the mechanism of M.L.’s injury remains “a
4                                           LALONDE   v. HHS

sequence hitherto unproven in medicine.” 418 F.3d at
1280. Medical certainty is not the standard for a Vaccine
Act claim: “[t]he determination of causation in fact under
the Vaccine Act involves ascertaining whether a sequence
of cause and effect is ‘logical’ and legally probable, not
medically or scientifically certain.” Knudsen v. Sec’y of
Health & Human Servs., 35 F.3d 543, 548–49 (Fed. Cir.
1994). Precedent also confirms that a claimant may
satisfy the Vaccine Act burden with circumstantial evi-
dence, Althen, 418 F.3d at 1279–80.
     The Vaccine Act also provides that even if there was a
preexisting weakness, the resultant injury is compensable
when it is aggravated by the vaccine. See 42 U.S.C.
§300aa-11(c)(1)(C)(ii)(I) (compensation is available if a
vaccination “significantly aggravated[] any illness, disa-
bility, injury, or condition not set forth in the Vaccine
Injury Table but which was caused by a vaccine referred
to in” the Vaccine Injury Table); Locase v. Sec’y of Health
& Human Servs., 685 F.3d 1375, 1379 (Fed. Cir. 2012).
    Petitioner’s expert witness Dr. Kinsbourne, Professor
of Pediatric Neurology at Duke University, posited three
possible mechanisms for how the DTaP vaccine could
have resulted in M.L.’s injuries. He explained that the
mechanism of anaphylaxis includes impairment of blood
flow through blood vessels and impairment of oxygena-
tion, which mechanisms are consistent with damage of
the cerebral circulation. Dr. Kinsbourne discussed M.L.’s
reaction to the vaccine, identified the mechanisms that
are frequently part of such reaction, and explained how
those mechanisms could have caused M.L.’s injury. He
explained how the impairment of oxygenation and blood
flow can affect speech. He wrote in his expert report that
M.L. was impaired in expressive language and that he
only recently began to eat solid foods and had yet to
regain his potty-training. He stated that he relied on the
medical literature for aspects of M.L.’s case with which he
did not have personal experience. He acknowledged that
LALONDE   v. HHS                                         5

he had not previously seen speech impairment as a reac-
tion to the DTaP vaccine, and that he had found no publi-
cation of scientific/medical study of this aspect. He gave
his expert opinion that it was more likely than not that
M.L.’s injuries were caused by the vaccine.
    The Court of Federal Claims, affirming the Special
Master, adopted the opinion of the government’s expert,
Dr. MacDonald, that M.L.’s speech disability was caused
by a “deep bilateral middle ear infection.” The record does
not show that M.L. had an ear infection at or about the
time of his vaccinations, and MRIs on April 26, 2005 and
November 25, 2005 were described as normal, with the
exception of pan-sinusitis seen in the November MRI. A
physician’s report on December 27, 2005 stated that M.L.
had fluid behind both ears, and suggested that this was
leading to conductive hearing loss; this physician also
wrote that he has seen nerve deafness resulting from a
vaccination. To support his theory, Dr. McDonald re-
ferred to a notation in M.L.’s 15-month checkup that M.L.
did not “want to talk.” Dr. McDonald dismissed the
records of M.L.’s physicians with respect to M.L.’s situa-
tion before and after the vaccinations and expressed
skepticism regarding their treatment plans.
    The Special Master found Dr. MacDonald more “cred-
ible” than Dr. Kinsbourne, and challenged Dr. Kins-
bourne’s credibility in part because he relied on an
unsigned narrative of events provided by M.L.’s mother,
Mrs. LaLonde. Although my colleagues observe that the
Court of Federal Claims dismissed the Special Master’s
credibility determination as erroneous, for Mrs. LaLonde’s
narrative also appeared in a signed and sworn affidavit
that the court found to be both reliable and consistent
with M.L.’s medical records, nonetheless my colleagues
rule that the petitioner did not submit “trustworthy” and
“sufficient” testimony. My colleagues also discard this
court’s admonition that contemporaneous written state-
ments of treating physicians are “particularly probative.”
6                                           LALONDE   v. HHS

Capizzano, 440 F.3d at 1326. This court has often ob-
served the difficulties associated with providing scientific
proof of vaccine injury causation; thus the court has
stressed the standards of reasonableness and likelihood,
objectively applied to the particular circumstances. See
Knudsen, 35 F.3d at 548–49 (“[T]o require identification
and proof of specific biological mechanisms would be
inconsistent with the purpose and nature of the vaccine
compensation program.”).       The court’s holding today
contravenes not only precedent, but also the purpose of
the Vaccine Act.
    As a further consideration in this case, Petitioner
LaLonde had requested remand in order to provide addi-
tional evidence. The record does not describe the prof-
fered evidence, but since the denial of compensation was
based on an evidentiary requirement that departed from
precedent, minimal fairness required inquiry into the
additional evidence. Instead, this too was denied.
    I respectfully dissent.