LOREN A. SMITH, Senior Judge.
Petitioners, Jordia Nunez and John Diaz, on behalf of their deceased minor child, J.J.D. ("J.J."),
A brief recitation of the facts provides necessary context.
In 2012, Ms. Nunez became pregnant with twins. Due to Ms. Nunez's medical history and her pregnancy being a twin gestation, doctors considered the pregnancy high risk. On July 11, 2012, Ms. Nunez naturally delivered twins, who were born at approximately twenty-nine weeks and two days' gestation. Due to his prematurity and episodes of respiratory distress, J.J. remained in the neonatal intensive care unit ("NICU") after delivery. The NICU discharged J.J. home in stable condition on August 31, 2012.
Dr. Yves Verna received J.J. on September 13, 2012, for his two-month well-baby examination. At that appointment, J.J. received his rotavirus, DTaP, HiB, IPV, and pneumococcal conjugate vaccines. Dr. Verna instructed J.J.'s parents to give him Tylenol every four hours for forty-eight hours after vaccination.
On November 14, 2012, Dr. Verna performed J.J.'s four-month well-baby examination and documented no abnormalities during the examination. During this appointment, J.J. received the HBV, rotavirus, DTaP, HiB, IPV, and pneumococcal conjugate vaccines. Notes taken during the examination show that the vaccines were administered between 5:40 p.m. and 6:24 p.m. Dr. Verna again instructed J.J.'s parents to give him Tylenol every four hours for forty-eight hours after his second round of vaccinations.
The following day, on November 15, 2012, a 911 call was placed from Ms. Nunez's residence at 9:49 a.m. The caller stated that J.J. was not breathing, and Emergency Medical Services ("EMS") arrived at petitioners' home around 9:53 a.m. The EMS crew members found J.J. unresponsive but found no injuries upon physical examination. Once J.J. arrived at the hospital, he was pronounced dead at 10:23 a.m.
Dr. Ye Aung, the attending physician at the hospital, transcribed notes that provide the following timeline of events provided by petitioners at the hospital on the day of J.J.'s death. J.J. was cranky after he received the vaccines, and petitioners gave him Tylenol. Petitioners fed J.J. formula at 9:30 p.m., and placed him in the same bed as his twin sister around 11:00 p.m. Ms. Nunez checked on J.J. and his twin sister around 8:30 a.m. and found them both asleep. Mr. Diaz brought J.J.'s twin into the living room after she woke around 9:00 a.m. When Ms. Nunez checked on J.J. at 9:30 a.m., she saw that his face was blue, and discovered that he was unresponsive. She immediately called 911 and began cardiopulmonary resuscitation.
An autopsy performed by Dr. James Gill on November 16, 2012, found the cause of death to be SIDS.
Petitioners filed their vaccine petition on September 17, 2014, pursuant to the Vaccine Act. Petitioners amended their petition on June 19, 2015, alleging that the adverse reaction from the vaccines administered on November 14, 2012, resulted in their son's death. See Amended Petition at 1. Additionally, petitioners filed an expert report authored by Dr. Douglas Miller,
Petitioners filed their Motion for Review on April 29, 2019. See generally Motion for Review (hereinafter "MFR"). Respondent filed its Response to petitioners' Motion for Review on May 28, 2019. See generally Response to Respondent's Motion for Review (hereinafter "Resp."). Petitioners' Motion is fully briefed and ripe for review.
Under the Vaccine Act, this Court may review a special master's decision upon the timely request of either party. See 42 U.S.C. § 300aa-12(e)(1)-(2). Upon receiving a timely request, the Court may: "(A) uphold the findings of fact and conclusions of law. . ., (B) set aside any findings of fact or conclusion of law . . . found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law . . ., or, (C) remand the petition to the Special Master for further action in accordance with the court's direction." Id. § 300aa-12(e)(2)(A)-(C). Findings of fact and discretionary rulings are reviewed under an "arbitrary and capricious" standard, while legal conclusions are reviewed de novo. Munn v. Sec'y of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992).
This Court cannot "substitute its judgment for that of the special master merely because it might have reached a different conclusion." Snyder ex rel. Snyder v. Sec'y of Dep't of Health & Human Servs., 88 Fed. Cl. 706, 718 (2009). "Reversal is appropriate only when the special master's decision is arbitrary, capricious, an abuse of discretion, or not in accordance with the law." Id. Under this standard, a special master's decision "must articulate a rational connection between the facts found and the choice made." Cucuras v. Sec'y of Dep't of Health & Human Servs., 26 Cl. Ct. 537, 541-42 (1992), aff'd, 993 F.2d 1525 (Fed. Cir. 1993) (citing Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)). This standard is "highly deferential." Hines v. Sec'y of Dep't of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991). "If the special master has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely difficult to demonstrate." Id.
Althen v. Secretary of Health & Human Services provides the evidentiary burden for petitioners attempting to succeed in a vaccine petition based on causation. See generally Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). There are two means of proving causation under the Vaccine Act: (1) showing that the injury falls under the Vaccine Injury Table, which provides a presumption of causation; and (2) proving causation-in-fact for an injury not listed on the Vaccine Injury Table. See id. at 1278 (citing 42 U.S.C. §§ 300aa-14(a), -13(a)(1), -11(c)1(C)(ii)(I)). The latter applies to this case, thus, in order to prove causation-in-fact, a petitioner must
Id. at 1278. To meet the preponderance standard and succeed on the claim, petitioners must provide a "reputable medical or scientific explanation" for their claim. See id.
Petitioners make two numbered objections to the March 29, 2019 decision. See MFR at 5, 24. First, petitioners assert that the Special Master erroneously heightened petitioners' burden of proof required under Althen prongs I and II. MFR at 5. Second, petitioners argue that the Special Master abused her discretion by failing to review the record as a whole, relying on respondent's expert despite the Special Master's criticism of the expert's testimony. MFR at 24.
In proceedings before the Special Master, petitioners relied upon the Triple Risk Model
During the entitlement hearing, petitioners and respondent disputed the applicability of the first factor in the Triple Risk Model. See Dec. at 11. While the Special Master initially identified J.J.'s male gender and prematurity as increasing his risk of SIDS, the Special Master analyzed evidence of a defect in J.J.'s brain to determine whether J.J. qualified as a vulnerable infant. See Dec. at 12-16. Dr. Miller stated that medical and scientific literature has shown that "the brain structures responsible for regulation of respiration, including those that sense increased blood carbon dioxide levels during sleep and respond[] to them with arousal and increased (gasping) breathing, reside in the medulla [oblongata]
Turning to the second factor, whether J.J. was in a critical developmental period was not in dispute, as he was four months old when he died, and the critical development period is considered the first year of life under the Triple Risk Model. See Dec. at 16. Therefore, the Special Master summarily found that J.J. was in a critical development period and fulfilled the second factor under the Triple Risk Model. Id.
Finally, the Special Master examined multiple possible exogenous factors linked with J.J.'s death. Dr. McCusker explained in her report that exogenous factors are "those elements which may contribute to a change in the mechanics of respiration, as opposed to the neurochemical." Resp't's Ex. A at 3. Examples of exogenous factors include: "prone or side sleeping, bed sharing, over-bundling, soft bedding, face covered and upper respiratory tract infection." Resp't's Ex. A at 3. Dr. McCusker identified J.J.'s co-sleeping with his twin, bottle feeding, and an upper respiratory tract infection ("URI") as exogenous factors that contributed to J.J.'s death. Resp't's Ex. A at 3. Dr. Folkerth identified the relevant exogenous factors to include J.J.'s premature birth, the existence of "additional known risk factors of a potentially unsafe sleeping environment (co-sleeping with his twin), and male gender." Resp't's Ex. C at 7. During the entitlement hearing before the Special Master, Dr. Folkerth noted a potential additional risk factor as J.J.'s alleged runny nose and cold at the time of his death, which petitioners noted in their affidavits. See Tr. 135:5-7. Lastly, Dr. Miller opined that J.J.'s intrinsic risk factors were prematurity and male gender. See Tr. 80:25-81:6. However, Dr. Miller stated that "the most important potential external stressor" was the vaccinations J.J. received on November 14, 2012. See Pet'rs' Ex. 12 at 4.
The Special Master found that it was more likely than not that J.J. had a runny nose, but that he was not suffering from a URI. See Dec. at 25. Additionally, the Special Master found that "co-sleeping was not a relevant risk factor in this case" based on respondent's concession after testimony from Ms. Nunez, and further determined that J.J.'s partial bottle feeding was not a significant factor. Id. at 18-20. Special Master Sanders also determined that the use of the receiving blanket "based on Ms. Nunez's description of how she loosely tucked it around J.J.'s legs, was not a relevant risk factor for SIDS." Id. at 20. Thus, the central argument examined in the Special Master's Decision is Dr. Miller's claim that the November 14, 2012 vaccinations were an exogenous stressor leading to J.J.'s SIDS death.
Special Master Sanders rejected Dr. Miller's theory of vaccinations as an exogenous stressor and found that petitioners failed to show causation-in-fact under the Althen standard. In their Motion for Review, petitioners argue that Special Master Sanders required direct evidence of a specific biological mechanism rather than merely a plausible theory that demonstrates a logical sequence of cause and effect pursuant to Althen prongs I and II. See MFR at 5. For the following reasons, the Court finds that the Special Master did not heighten petitioners' burden of proof under Althen prongs I and II.
Petitioners theorize that "J.J. ultimately succumbed to SIDS because increased levels of cytokines
When a Special Master finds petitioners' theory unconvincing, the Special Master does not necessarily raise petitioners' burden. LaLonde v. Sec'y of Health & Human Servs., 746 F.3d 1334, 1340 (Fed. Cir. 2014) (affirming the special master's conclusion that petitioner's theory of causation was unconvincing without improperly requiring petitioner's expert to provide proof of the proposed mechanism). Special Master Sanders correctly explained that "to require identification and proof of specific biological mechanisms would be inconsistent with the purpose and nature of the vaccine compensation program." Dec. at 50 (citing Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994)) (internal citations omitted). In this case, the Special Master carefully examined each element of Dr. Miller's theory, but found that: (1) he failed to present evidence of an active transport system for the cytokines to enter the brain, and (2) his arguments were undermined by the fact that J.J. had a defective brainstem as "cytokines need a normal brainstem to affect the 5-HT system because it is through functioning receptors that their messages are received." Dec. at 51. Special Master Sanders concluded that these findings proved fatal to Dr. Miller's theory that an increase in cytokine production levels directly led to the failure to rouse J.J., resulting in his death. See Dec. at 50-51. Accordingly, the Court finds that the Special Master did not heighten petitioners' burden of proof required under Althen prongs I and II.
Petitioners' second numbered objection states that the Special Master failed to review the record as a whole and relied on the testimony of Dr. McCusker after criticizing her testimony. MFR at 24. In her Decision, Special Master Sanders found that "Dr. McCusker can, at times, overstate her position, particularly as it relates to providing support to some of her conclusions." Dec. at 51. Specifically, the Special Master identified as unnecessary overreach Dr. McCusker's addition of the loosely tucked sheet as a risk factor as well as her later withdrawal of the assertion that several studies showed increased carbon dioxide associated with infants having a URI. See Dec. at 51-52. In their Motion for Review, petitioners identify additional alleged issues with Dr. McCusker's testimony, and contend that the Special Master failed to address those problems. See MFR at 25-33. Respondent argues that the Special Master appropriately criticized Dr. McCusker's testimony in her Decision, and that she adequately examined both experts in finding Dr. McCusker's explanations for why Dr. Miller's theory must fail was credible. See Resp. at 13. The Court finds that Special Master Sanders neither abused her discretion nor acted contrary to law, as she appropriately considered the record as a whole and adequately explained her determinations as to the reliability of the evidence and credibility of the expert witnesses.
It is well-established that this Court does "not reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses—these are all matters within the purview of the fact finder." Porter v. Sec'y of Heath & Human Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011) (stating that the United States Court of Appeals for the Federal Circuit applies the same standard of review over the special master's decision as the Court of Federal Claims applies in its review of the special master's decision). Respondent correctly points out that the Special Master's analysis of the evidence is consistent with the requirements established under the Vaccine Program. See Resp. at 13. While petitioners argue that Dr. McCusker's testimony was not adequately addressed by the Special Master in her decision, Special Master Sanders explained that all testimony was thoroughly reviewed even if not referenced in the Decision. Dec. at 52.
In addition to evidence at the entitlement hearing, the Special Master considered multiple prior vaccine cases where petitioners alleged vaccines caused SIDS. See Dec. at 47-50. Special Master Sanders identified one prior case where petitioners were initially successful on this theory, but where the Court of Federal Claims ultimately reversed the special master's decision. See Boatman v. Sec'y of Health & Human Servs., 2017 WL 3432329 (Fed. Cl. Spec. Mstr. July 10, 2017), rev'd, 138 Fed. Cl. 566 (2018) (reversing the special master's decision for applying too low of a standard where the special master accepted petitioners' theory of liability based on SIDS under the Triple Risk Model). As stated in Special Master Sanders' decision, "[t]his theory has been unsuccessfully litigated in the Program previously, and Dr. Miller did not present any new persuasive evidence." Dec. at 52. Accordingly, the Court finds that the Special Master appropriately reviewed the record as a whole and articulated a rational basis for her decision to rely on Dr. McCusker's testimony.
This Court finds that the Special Master's decision was neither an abuse of discretion nor contrary to law, and that the Special Master's findings were neither arbitrary nor capricious. For the foregoing reasons, the Court
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