Boatmon v. Secretary of Health and Human Services

          Appeal from the United States Court of Federal Claims in No. 1:13-vv-00611-TCW, Judge Thomas C. Wheeler.

          Joseph Pepper, Conway Homer, PC, Boston, MA, argued for petitioners-appellants. Also represented by Ronald C. Homer.

          Thomas G. Ward, Torts Branch, Civil Division, United States Department of Justice, Washington, DC, argued for respondent-appellee. Also represented by Robert Paul Coleman, III, Joseph H. Hunt, C. Salvatore D'Alessio, Catharine E. Reeves.

          Before Prost, Chief Judge, Newman and Wallach, Circuit Judges.

          OPINION

          PROST CHIEF JUDGE

         This case, brought under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34, as amended (the "Vaccine Act"), presents the question of whether Petitioners Chase Boatmon and Maurina Cupid have proven by a preponderance of the evidence that the vaccinations their son, J.B., received caused or substantially contributed to his death from sudden infant death syndrome ("SIDS"). The Special Master found that Petitioners had met their burden and were entitled to compensation. Boatmon v. Sec'y of Health & Human Servs., No. 13-611V, 2017 WL 3432329 (Fed. Cl. Spec. Mstr. July 10, 2017) ("Special Master Decision"). The United States Court of Federal Claims reversed the Special Master's finding. Boatmon v. Sec'y of Health & Human Servs., 138 Fed.Cl. 566 (2018). While we disagree with most of the Court of Federal Claims' rationale, for the reasons explained below, we affirm its judgment.

         I

         A

         J.B. was born four weeks prematurely on April 7, 2011. Special Master Decision, at *4. Despite being born prematurely, J.B. was progressing with normal growth and development. At his four-month well baby visit on September 2, 2011, J.B. was healthy, with normal chest and lungs and no fever, nasal congestion, or cough. At that appointment, J.B. received vaccinations for diphtheriatet-anus-acellular pertussis (DTaP), inactivated polio (IPV), pneumococcal conjugate (PCV), rotavirus, and Hepatitis B (Hep B). Id.

         Later that evening, J.B. reportedly had a fever and did not sleep well. See id. at *5. At 4:00 AM on September 3, 2011, J.B.'s parents gave him Advil for his fever, and he went back to sleep. By approximately 8:00 AM, J.B. was again running a fever and was given another dose of Advil.

         In the early afternoon, J.B.'s father put him down for a nap on his back in his crib. J.B.'s mother checked on him and replaced his pacifier. She returned to check on him a second time and found him unresponsive on his right side. At 2:39 PM, J.B.'s mother called 911 and attempted CPR. Responders arrived at the house within minutes and transported J.B. to the hospital. Efforts to resuscitate J.B. were unsuccessful and he was pronounced dead at 4:01 PM. See id. at *6.

         A death investigation and scene reenactment indicated that J.B. was placed to sleep on his back and was found on his right side. Photographs of the scene showed that his crib contained soft blankets and a flat soft pillow but no clutter or toys.

         The medical examiner performed an autopsy and concluded that the cause of death was SIDS.^[1] Id.

         B

         The Vaccine Act, enacted in 1986, created the National Vaccine Injury Compensation Program, through which claimants can petition to receive compensation for vaccine-related injuries or death. See 42 U.S.C. § 300aa-10(a).

         There are two ways a petitioner can qualify for compensation under the program. First, if the petitioner can establish an injury listed on the Vaccine Act Injury Table that occurred after the administration of a designated vaccine within a designated period of time ("Table cases"), then causation is presumed. See id. §§ 300aa-11(c), 300aa-14(a). Second, if the petitioner claims an injury not listed in the Vaccine Act Injury Table ("off-Table cases"), the petitioner must prove, by a preponderance of the evidence, that the vaccine was the cause-in-fact of the claimed injury. Id. §§ 300aa-11(c)(1)(C)(ii)(I), 300aa-13(a)(1). "[A] proximate temporal association alone does not suffice to show a causal link between the vaccination and the injury." Grant v. Sec'y of Dep't of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992); see also LaLonde v. Sec'y of Health & Human Servs., 746 F.3d 1334, 1341 (Fed. Cir. 2014) ("As we have stated before, a temporal correlation alone is not enough to demonstrate causation."). The dissent's suggestion that temporal proximity of the vaccination to the injury creates a prima facie case of connection or causation is contrary to our precedent. Dissent Op. 7-10.

         Rather, to prove causation in fact in an off-Table 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 vaccination and injury.

Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1321-22 (Fed. Cir. 2010) (quoting Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005)). These requirements are known as the three Althen prongs. If a petitioner proves all three Althen prongs by a preponderance of the evidence, he or she is entitled to recover unless the government shows "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 the Dep't of Health & Human Servs., 35 F.3d 543, 547 (Fed. Cir. 1994)).

         C

         J.B.'s parents filed a petition for compensation under the Vaccine Act, alleging that the vaccinations their son received contributed to his death from SIDS. Because this was an off-Table case, the Petitioners were required to prove causation in fact by establishing each of the three Al-then prongs by a preponderance of the evidence.

         The case was assigned to a Special Master, who held an evidentiary hearing. The Special Master considered medical and scientific literature as well as expert testimony from Dr. Douglas Miller for the Petitioners and Dr. Christine McCusker and Dr. Brent Harris for the government.

         The parties do not dispute that J.B.'s cause of death was SIDS. See Special Master Decision, at *6. "SIDS is defined as 'the sudden death of an infant under one year of age which remains unexplained after a thorough case investigation, including performance of a complete autopsy, death scene investigation, and review of the clinical history.'" Id. at *7 (quoting James J. Filiano & Hannah C. Kinney, Arcuate Nucleus Hypoplasia in the Sudden Infant Death Syndrome, 51 J. Neuropathology & Experimental Neurology 394 (1992)). Studies indicate that SIDS occurs during sleep or transitions between sleep and waking. Id.

         Dr. Hannah C. Kinney, a neuropathologist at Harvard, is an undisputed leader in SIDS research and understanding. In 1994, Dr. Kinney and her colleagues "synthesized many neuropathological studies into their proposed 'Triple Risk Model.'" Id. This model posits that SIDS is "multifactorial," occurring "when: (1) an infant in a critical development period; (2) possessing an underlying vulnerability; (3) encounters an exogenous stressor." Id. at *7-8, *33. The following Venn diagram has been used to illustrate the Triple Risk Model:

         (Image Omitted)

         Id. at *7.

         The first factor, the critical development period, was initially defined as the first year of life, but has more recently been understood to be the first six months of life. Id. at *8. The second factor, an underlying intrinsic vulnerability in the infant, includes prematurity, "'male gender, African-American race, poverty, adverse prenatal factors such as maternal smoking or alcohol use during pregnancy, . . . genetic polymorphisms, '" and "brainstem abnormality in the neuroregulation of cardiorespiratory control." Id. (quoting Hannah C. Kinney et al., The Brainstem and Serotonin in the Sudden Infant Death Syndrome, 4 Annu. Rev. Pathol. Mech. Dis. 517, 519, 521 (2009) (J.A. 553-88) ("Kinney 2009")). The third factor, exogenous stressors, has been identified in the literature to include "prone sleep position, face-down position, covered face in the supine position, soft bedding, bed sharing, over-bundling, elevated room temperature, and minor infection at the time of death." Id. at *10 (citing Kinney 2009, at 519 (J.A. 555)).

         Dr. Miller, the Petitioners' expert, theorized that receiving a vaccine can be an exogenous stressor for SIDS because its prompts the upregulation of cytokines. Id. at *21 ("Dr. Miller stated that vaccinations can be an extrinsic risk factor in SIDS, as they prompt the upregulation of cytokines that, among other things, produce fever."). According to Dr. Miller, the upregulation of cytokines following vaccinations can be similar to the upregulation of cytokines associated with a mild infection, a known extrinsic risk factor for SIDS. Id. at *20-21. Dr. Miller theorized that the cytokines can inhibit the activity of 5-hydroxytryptamine ("5-HT" or serotonin) neurons in the medulla causing prolonged apneas and interference with autoresuscitation. Id. Approximately 50-70% of infants who die of SIDS appear to have abnormalities in the medullary 5-HT system. Id. at *8. According to Dr. Miller's theory, "[w]hen the vaccines are administered in the presence of the defects in the medulla, during the critical developmental period, they are likely to have a similar effect as mild infection that may cause a failure of the medullary response system and ultimately a death." Id. at *21. But by Dr. Miller's own admission, no other medical professionals or researchers have adopted his theory. See J.A. 161-62; see also Special Master Decision, at *21.

         Dr. McCusker disagreed with Dr. Miller's theory. Specifically, she disagreed that upper respiratory infections- and by Dr. Miller's extension, vaccinations-act as neuro-chemical exogenous stressors. Special Master Decision, at *23. Instead, Dr. McCusker testified that upper respiratory infections, like the other identified exogenous stress-ors, are mechanical, meaning that they interfere with an infant's ability to exhale carbon dioxide and inhale fresh oxygen. Id. at *23, *25.

         The Special Master found that the Petitioners had established all three Althen prongs by a preponderance of the evidence. On Althen prong one, the Special Master adopted Dr. Miller's extension of the Triple Risk Model, concluding that "vaccines can . . . play a critical role . . . by stimulating the production of inflammatory cytokines." Id. at *39. We note for clarity that the Special Master also stated that "I have not concluded that vaccines present a substantial risk of SIDS. In fact, the evidence is to the contrary." Id. at *42.

         On the second Althen prong, the Special Master found that "the cytokines triggered by the vaccines" in combination with "other intrinsic and/or extrinsic risk factors in the presence of a defective or underdeveloped brainstem seems likely to have produced the perfect storm that resulted in J.B.'s death." Id. at *41 (emphasis added). The Special Master's analysis of the second Althen prong therefore depends on J.B. having a defective or underdeveloped brain-stem. But notably, the autopsy did not examine or section J.B.'s arcuate nucleus or other medullary areas to determine whether J.B. had any such brainstem abnormality. Id. at *7, *30-31. The Special Master found that the Petitioners had proven by a preponderance of the evidence that J.B. had a brainstem abnormality based, in part, on statistical evidence that a brainstem defect is found in 50-70% of SIDS cases and Dr. Miller's testimony that, based on this statistical evidence, J.B. likely had the defect. See id. at *32.

         The Special Master also found that Petitioners had established the temporal requirement of the third Althen prong. See id. at *42. The Special Master therefore found in favor of the Petitioners. Id. at *42-43.

         D

         The government sought review of the Special Master's decision in the Court of Federal Claims. The Court of Federal Claims reversed the Special Master, finding "as a matter of law that the Special Master erred in ruling for Petitioners, and in finding that Petitioners had met their burden of proof as established by applicable statutes and case law." Boatmon, 138 Fed.Cl. at 567; see also id. at 571 (faulting the Special Master's "improper application of the standard of proof required in vaccine cases").

         The Court of Federal Claims reviewed four decisions by three other Special Masters that considered Dr. Miller's theory of vaccination causation in other SIDS cases and "uniformly found that the evidence presented by Dr. Miller to prove his theory of vaccine causation was not persuasive." Id. at 571.^[2] Despite acknowledging that "[a] Special Master is not bound to follow the opinions of other Special Masters," the Court of Federal Claims criticized the Special Master for "ma[king] no acknowledgement of the other cases reaching opposite conclusions and ma[king] no attempt to distinguish the instant case from any of the others." Id.

         The Court of Federal Claims determined that the Special Master erred by accepting Dr. Miller's theory because it was not "supported by a 'sound and reliable' medical or scientific explanation" because it has "not been accepted by any other experts in the field of SIDS research." Id. at 571- 72 (quoting Knudsen, 35 F.3d at 548). In doing so, the Court of Federal Claims invoked Daubert and criticized Dr. Miller's theory for not having "been subjected to peer review and publication." Id. at 572 (citing Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 593 (1993)). According to the Court of Federal Claims, by accepting Dr. Miller's unsupported theory, the Special Master "applied a standard so low as to constitute clear error." Id.

         The Court of Federal Claims reversed the Special Master, concluding that "having found that Petitioners failed to satisfy Althen Prong One, the Court also finds that they have not presented a persuasive basis for finding that the vaccinations caused J.B.'s death, as required under Althen Prong Two." Id.

         The Petitioners appealed the Court of Federal Claims' decision. We have jurisdiction pursuant ...