LaLonde ex rel. M.L. v. Secretary of Health & Human Services

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. 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, 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 pathological markers or genetic disposition, or general acceptance 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 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.” 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 evidence, 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, disability, injury, or condition not set forth in the Vaccine Inju *1343 ry Table but which was caused by a vaccine referred to in” the Vaccine Injury Table); Locane v. Sec’y of Health & Human Servs., 685 F.3d 1375, 1379 (Fed.Cir.2012).

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, 440 F.3d at 1326 . This court has often observed 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 *1344 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 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.