Lead Opinion
Opinion for the court filed by Circuit Judge PROST. Dissenting opinion filed by Circuit Judge NEWMAN.
This case, brought under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-l 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 ana-phylaxis caused a focal brain injury. See La Londe v. Sec’y of Health & Human Servs., No. 06-435V,
The relevant facts are primarily those found by the special master in his detailed September 28, 2012 decision. See La Londe,
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. Kinsb-ourne testified that M.L. experienced 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 describes 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. La Londe,
On review, the Court of Federal Claims concluded that the special master abused his discretion by discrediting Dr. Kinsb-ourne’s opinions that were based on statements made by Ms. LaLonde, even if some of her statements were in conflict with the medical records. La Londe,
We have jurisdiction to review the final judgment of the Court of Federal Claims under 42 U.S.C. § 300aa-12(f).
III. The Vaocine 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-l; Terran v. Sec’y of Health & Human Servs.,
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 preexisting 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-exist-ing injury or condition not on the Table, in which case causation must be proven (a “non-Table injury”). See 42 U.S.C. §§ 300aa-ll(c)(l)(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 vaccination brought about [the] 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 the injury.
Moberly ex rel. Moberly v. Sec’y of Health & Human Servs.,
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,
V. DISCUSSION
On appeal, Ms. LaLonde argues that the special master made a legal error when he denied her claim for compensation. Relying on Knudsen v. Secretary of Health and Human Services,
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,
Finally, Ms. LaLonde reminds the court that the purpose 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,
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. La-Londe correctly states in her opening brief, “to require identification and proof of a specific biologic mechanism [in Vaccine Act eases] would be inconsistent with the purpose and nature of the vaccine compensation program.” Pet’r’s Br. 18 (quoting Knudsen,
Ms. LaLonde’s expert, Dr. Kinsb-ourne, 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
Thus, contrary to Ms. LaLonde’s argument, the special 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.,
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.’ ”
Furthermore, as the finder of fact, the special master was responsible for assessing the reliability of Dr. Kinsbourne’s testimony by looking for reliable medical or scientific support. See Moberly,
Additionally, it was not the government’s burden to provide an alternative explanation. See, e.g., Althen,
In Vaccine Act eases, petitioners must proffer trustworthy testimony from experts who can find support for their theories in medical literature in order to show causation under the preponderance of the evidence standard. 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,
VI. CONCLUSION
In this case, as in Moberly, the special master and the Court of Federal Claims applied the correct legal standard 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
Costs
Each party shall bear their own costs.
Dissenting Opinion
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. received the diagnosis of “vaccine adverse reaction with secondary fever, angioedema, and anaphylactoid reaction.” The emergency doctor recorded that M.L. exhibited tongue and lip swelling, facial redness, was unable to 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 appeared to be a normal healthy child with an age appropriate vocabulary, and was reduced to mostly unintelligible 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 developmental specialist, and a speech therapist, whose reports are in the record. A treating physician wrote in September 2005:
*1342 Since the day of the shots, (M.L.) has lost the ability 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 present 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-likely-than-not causal relationship between M.L.’s vaccination 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 government’s expert, Dr. McDonald. However, even Dr. McDonald 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 immunization 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 explained in Althen v. Secretary of Health & Human Services,
Contrary to my colleagues’ ruling today, the requirement 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)(l)’s allowance of medical opinion as proof.” Id. As in Althen, the mechanism of M.L.’s injury remains “a sequence hitherto unproven in medicine.”
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, disability, injury, or condition not set forth in the Vaccine Inju
Petitioner’s expert witness Dr. Kinsb-ourne, 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 anaphy-laxis includes impairment of blood flow through blood vessels and impairment of oxygenation, 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 he had not previously seen speech impairment as a reaction to the DTaP vaccine, and that he had found no publication 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 referred 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 situation before and after the vaccinations and expressed skepticism regarding their treatment plans.
The Special Master found Dr. MacDonald more “credible” than Dr. Kinsb-ourne, and challenged Dr. Kinsbourne’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 statements of treating physicians are “particularly probative.” Capizzano,
As a further consideration in this case, Petitioner LaLonde had requested remand in order to provide additional evidence. The record does not describe the proffered 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.