JARANILLA v. SECRETARY OF HEALTH AND HUMAN SERVICES

CourtUnited States Court of Federal Claims
DecidedNovember 29, 2023
Docket22-0428V
StatusPublished

This text of JARANILLA v. SECRETARY OF HEALTH AND HUMAN SERVICES (JARANILLA v. SECRETARY OF HEALTH AND HUMAN SERVICES) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
JARANILLA v. SECRETARY OF HEALTH AND HUMAN SERVICES, (uscfc 2023).

Opinion

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS

********************** KELSEY AND RYAN JARANILLA, * on behalf of their minor daughter BJ, * * No. 22-428V Petitioners, * Special Master Christian J. Moran * v. * * Filed: November 1, 2023 SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * *********************** Michael A. Firestone, The Law Firm of Marvin Firestone, MD, JD & Associates, LLP., San Mateo, CA, for petitioners; Jennifer A. Shah, United States Dep’t of Justice, Washington, DC, for respondent.

PUBLISHED DECISION DENYING MOTION FOR AN AWARD OF AN UNINCURRED COST ON AN INTERIM BASIS 1

Kelsey and Ryan Janarilla allege that various childhood vaccines caused their daughter, B.J., to suffer cerebral palsy and other injuries. In an effort to support their claim, the Janarillas have sought an order for the Vaccine Compensation Trust Fund to pay for genetic tests on B.J. The Secretary has opposed this request. As explained below, legal requirements and factual

1 Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the parties have 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. Any changes will appear in the document posted on the website. impediments prevent this the approval of the Janarillas’ request. Thus, their motion is DENIED.

I. Medical History

B.J. was born in January 2020 with some complications. Exhibit 2 at 8. However, B.J.’s pediatrician did not note any significant medical concerns during well-baby visits through July 2020. Exhibit 5 at 39-67.

B.J. had another well-baby visit on July 27, 2020. The pediatrician, Dr. Cotey, noted that B.J. was ahead of developmental milestones. Exhibit 5 at 42. Her exam was normal. B.J. received her diphtheria-tetanus-acellular pertussis, inactivated poliovirus, hepatitis B, pneumococcus, and rotavirus vaccines. Id. at 41. Ms. Jaranilla stated that in the next 15 days, B.J. was in her usual state of health. Exhibit 1 (affidavit) at 1-2. B.J.’s sleeping, eating, and playing habits did not change. Id.

On August 12, 2020, which is 16 days after the vaccination, B.J. appeared to have a seizure for which she was taken to a local emergency department. Exhibit 4 at 9. Her temperature was 100.8. Id. at 10. Attempts to halt the seizures were not immediately successful and she was eventually intubated. Id. After the seizures were controlled, B.J. was transferred to Doernbecher Children’s Hospital (“Doernbecher”) at the Oregon Health & Science University. B.J. remained hospitalized at Doernbecher for two weeks and was discharged on August 26, 2020. Exhibit 6, passim. B.J. underwent multiple tests, including multiple MRIs. In the discharge report, a neurologist stated: “Diagnostically, it remains unclear if this represents a severe systemic viral infection or a viral illness unmasking a metabolic disorder.” Id. at 125.

In the ensuing months, B.J. continued to see various doctors and to participate in various types of therapies. She was diagnosed as having cerebral palsy.

Mr. and Ms. Jaranilla eventually sought a second opinion from a neurologist, Jennifer Yuen. Dr. Yuen ordered genetic testing. Exhibit 9 at 11. The tests evaluated B.J. for 304 genetic changes associated with genetic disorders. The results, which were reported on April 19, 2021, detected some abnormalities but none that would explain B.J.’s clinical manifestations. Id. at 28.

2 BJ’s doctor, Amy Yang, reviewed the results regarding genetic testing. Dr. Yang suggested that parental genetic testing may be useful. She also recommended whole genome sequencing (“WGS”). Whole genome sequencing could “potentially pick up chromosome abnormalities; [B.J.] has not had a chromosome microarray (CMA) in the past. In addition, WGS in 2021 may reveal new variants in newly described genes.” Exhibit 6 at 46-47 (May 14, 2021).

The health insurance company for the Jaranillas, United Healthcare, determined that it would not pay for the whole genome sequencing Dr. Yang recommended. Acting through a medical director, Dan Beruti, United Healthcare stated that its plan “doesn’t cover unproven procedures.” Exhibit 19 at 3 (Sept. 21, 2022). Dr. Beruti elaborated that whole genome sequencing “has not been shown to be helpful to [B.J.’s] condition.” Id. at 4. He also stated that “This is a benefit determination, not a medical decision. Only you and your doctor can decide what medical care you need.” Id. Finally, Dr. Beruti provided information about a process for appealing.

As discussed below, Mr. and Ms. Jaranilla maintain that March 28, 2021 genetic testing was not complete. Thus, they are requesting funding to obtain additional genetic testing.

II. Procedural History Represented by Michael Firestone, the Jaranillas filed their petition on April 12, 2022 and medical records on May 13, 2022. After reviewing this material, the Secretary maintained that the Jaranillas are not entitlement to compensation. Resp’t’s Rep., filed Oct. 21, 2022. The Secretary noted that B.J.’s doctors did not link her vaccinations to her health problems. Id. at 10. The Secretary also noted that the Jaranillas had not presented a report from an expert. Id. In a November 16, 2022 status conference, the Jaranillas suggested that a geneticist whom they had consulted, Dr. Dmitriy M. Niyazov, has recommended a whole genome test. The estimated cost was $3,000 to $5,000. They were directed to file a motion. Order, issued Nov. 22, 2022. A December 29, 2022 order directed the Jaranillas to support any forthcoming motion with information about their financial condition and the authority of special masters to order the Vaccine Trust Fund to pay for testing. The Jaranillas submitted their motion on January 17, 2023. Their motion referenced the denial letter from United Healthcare and a letter from Dr. Niyazov, which they had previously filed as Exhibits 19 and 20, respectively, on December

3 16, 2022. Dr. Niyazov recommends whole genome sequencing. The motion provided no information about the financial circumstances of the Jaranillas. The motion barely touched upon the authority of special masters to order payment for genetic testing.

The Secretary’s initial response was not helpful. Resp’t’s Resp., filed Feb. 20, 2023. At best, the Secretary quoted the portion of the December 29, 2022 order directing the Jaranillas to provide information about their financial situation. The Jaranillas filed some financial information on March 3, 2023. Exhibits 29-32. In light of this new evidence and in light of the deficiencies in the Secretary’s initial response, the Secretary was directed to file another response. Order, issued April 10, 2023.

Given a second chance, the Secretary opposed the award. The Secretary maintained “there is no reasonable basis for petitioners’ claim at this time,” “petitioners have failed to actually incur this cost or make a special showing justifying an award of interim costs at this stage of the litigation” and “there is no evidence that WGS testing will advance petitioners’ claim of vaccine causation.” Resp’t’s Resp., filed April 25, 2023, at 1.2

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JARANILLA v. SECRETARY OF HEALTH AND HUMAN SERVICES, Counsel Stack Legal Research, https://law.counselstack.com/opinion/jaranilla-v-secretary-of-health-and-human-services-uscfc-2023.