Leone v. Secretary of Health and Human Services

FRUUHFWHG In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS No. 23-407V

*************************

*

KIM LEONE, * Chief Special Master Corcoran

* Petitioner, * Filed: July 6, 2026 *

v. *

*

SECRETARY OF HEALTH * AND HUMAN SERVICES, *

*

Respondent. *

*

************************* Ronald C. Homer, Conway, Homer, P.C., Boston, MA, for Petitioner.

Gabrielle Manganiello Fielding, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION AWARDING DAMAGES1

On March 24, 2023, Kim Leone filed a petition seeking compensation under the National Vaccine Injury Compensation Program (“Vaccine Program”).2 Petition (ECF No. 1). Petitioner alleges that she suffered Guillain-Barre syndrome (“GBS”) that was caused-in-fact by her receipt of a tetanus, diphtheria, and acellular-pertussis (“Tdap”) vaccine on July 26, 2021. Id. Petitioner further alleges that she experienced residual effects of this condition for more than six months.

Respondent denies that Petitioner’s alleged GBS or its residual effects were caused-in-fact by the Tdap vaccine; and denies that the flu vaccine caused Petitioner any other injury or her current condition. Nevertheless, while maintaining their above-stated positions, both parties agreed in a stipulation (July 7, 2026) that the issues before them could be settled and that a decision should be entered awarding Petitioner compensation. Stipulation (ECF No. 54).

I have reviewed the file, and based upon that review, I conclude that the parties’ stipulation (“Stipulation”) (attached hereto as Appendix A) is reasonable. I therefore adopt it as my decision in awarding damages on the terms set forth therein.

The stipulation awards: x A lump sum payment of $41,000.00 to be paid through an ACH deposit to Petitioner’s counsel’s IOLTA account for prompt disbursement to Petitioner.

Stipulation ¶ 8. This amount represents compensation for all damages that would be available under Section 15(a) of the Act.

I approve a Vaccine Program award in the requested amount set forth above to be made to Petitioner. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court is directed to enter judgment herewith.3

IT IS SO ORDERED.

/s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master

IN THE UNITED STATES COURT OF FEDERAL CLAIMS

OFFICE OF SPECIAL MASTERS KIM LEONE,

Petitioner, No. 23-407V

Chief Special Master Corcoran V. ECF SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent.

STIPULATION

The parties hereby stipulate to the following matters:

1. Kirn Leone ("petitioner") filed a petition for vaccine compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10 et seq. (the "Vaccine Program"). The petition seeks compensation for an injury allegedly related to petitioner's receipt of the tetanus, diphtheria, and acellular-pertussis ("Tdap") vaccine, which is contained in the Vaccine Injury T able (the "Table"), 42 C.F.R. § 100.3(a).

2. Petitioner received a Tdap vaccine on July 26, 2021.

3. The vaccine was administered within the United States.

4. Petitioner alleges that the Tdap vaccine caused in fact her Guillain-Barre syndrome (OBS). Petitioner further alleges that she suffered the residual effects of the alleged injury for more than six months.

5. Petitioner represents that there has been no prior award or settlement of a civil action for damages on petitioner's behalf as a result of the alleged injury.

6. Respondent denies that the Tdap vaccine caused in fact or significantly aggravated petitioner's alleged GBS or any other injury, and further denies that petitioner's current condition is a sequela of a vaccine-related injury.

7. Maintaining their above-stated positions, the parties nevertheless now agree that the issues between them shall be settled and that a decision should be entered awarding the compensation described in paragraph 8 of this Stipulation.

8. As soon as practicable after an entry of judgment reflecting a decision consistent with the terms of this Stipulation, and after petitioner has filed an election to receive compensation pursuant to 42 U.S.C. § 300aa-2l(a)(l), the Secretary of Health and Human Services will issue the following vaccine compensation payment:

A lump sum of $41,000.00 to be paid through an ACH deposit to petitioner's counsel's IOLTA account for prompt disbursement to petitioner. This amount represents compensation for all damages that would be available under 42 U.S.C. § 300aa-15(a). 9. As soon as practicable after the entry of judgment on entitlement in this case, and after petitioner has filed both a proper and timely election to receive compensation pursuant to 42 U.S.C. § 300aa-2 l (a)( 1), and an application, the parties will submit to further proceedings before the special master to award reasonable attorneys' fees and costs incurred in any proceeding upon this petition.

10. Petitioner and petitioner's attorney represent that compensation to be provided pursuant to this Stipulation is not for any items or services for which the Program is not primarily liable under 42 U.S.C. § 300aa-15(g), to the extent that payment has been made or can reasonably be expected to be made under any State compensation programs, insurance policies, Federal or State health benefits programs (other than Title XIX of the Social Security Act (42 U.S.C. § 1396 et seq.)), or by entities that provide health services on a pre-paid basis.

11. Payment made pursuant to paragraph 8 and any amounts awarded pursuant to paragraph 9 of this Stipulation will be made in accordance with 42 U.S.C. § 300aa-l 5(i), subject to the availability of sufficient statutory funds.

12. The parties and their attorneys further agree and stipulate that, except for any award for attorneys' fees and litigation costs, the money provided pursuant to this Stipulation will be used solely for the benefit of petitioner as contemplated by a strict construction of 42 U.S.C. § 300aa-l 5(a) and (d), and subject to the conditions of 42 U.S.C. § 300aa-15(g) and (h).

13. In return for the payments described in paragraphs 8 and 9, petitioner, in petitioner's individual capacity, and on behalf of petitioner's heirs, executors, administrators, successors or assigns, does forever irrevocably and unconditionally release, acquit and discharge the United States and the Secretary of Health and Human Services from any and all actions or causes of action (including agreements, judgments, claims, damages, loss of services, expenses and all demands of whatever kind or nature) that have been brought, could have been brought, or could be timely brought in the Court of Federal Claims, under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10 et seq., on account of, or in any way growing out of, any and all known or unknown, suspected or unsuspected personal injuries to or death of petitioner resulting from, or alleged to have resulted from, the Tdap vaccination administered on July 26, 2021, as alleged by petitioner in a petition for vaccine compensation filed on or about March 24, 2023, in the United States Court of Federal Claims as petition No. 23-407V.

14. If petitioner should die prior to entry of judgment, this agreement shall be voidable upon proper notice to the Court on behalf of either or both of the parties.

15. If the special master fails to issue a decision in complete conformity with the terms of this Stipulation or if the Court of Federal Claims fails to enter judgment in conformity with a decision that is in complete confonnity with the terms of this Stipulation, then the parties' settlement and this Stipulation shall be voidable at the sole discretion of either party.

16. This Stipulation expresses a full and complete negotiated settlement of liability and damages claimed under the National Childhood Vaccine Injury Act of 1986, as amended, except as otherwise noted in paragraph 9 above. There is absolutely no agreement on the part of the parties hereto to make any payment or to do any act or thing other than is herein expressly stated and clearly agreed to. The parties further agree and understand that the award described in this Stipulation may reflect a compromise of the parties' respective positions as to liability and/or amount of damages, and further, that a change in the nature of the injury or condition or in the items of compensation sought, is not grounds to modify or revise this agreement.

17. This Stipulation shall not be construed as an admission by the United States or the Secretary of Health and Human Services that the Tdap vaccine caused petitioner's alleged GBS or any other injury or petitioner's current disabilities, or that petitioner suffered an injury contained in the Vaccine Injury Table.

18. All rights and obligations of petitioner hereunder shall apply equally to petitioner's heirs, executors, administrators, successors, and/or assigns.

END OF STIPULATION

I I I I I I I I I I I I Respectfully submitted, PETITIONER: q__,i/J?L J,/C. ;,fl,7c--R KIM LEONE ,.,1/ ~ ATTORNEY OF RECORD FOR AUTHORIZED REPRESENTATIVE PETJTlON8R: OF THE ATTORNEY GENERAL:

~c~Y-.P~~ •. HOMER, ESQ. /4wJ~.1ttJl. HEATHER 1.. PEARLMAN Conway Homer. P.C. Deputy Director 16 Shawmut Street Torts Branch, Civil Division Boston. MA 02 I l 96 U.S . Depal'tmcnt of Justice Tel: (617) 695- 1990 P.O. Box 146 £mail: [email protected] Benjamin Franklin Station

Washington. DC 20044-0146 AUTHORlZED REPRESENTATIVE ATTORNEY OF RECORD fOR OF THE SECRETARY OF HEALTH RESPONDENT:

AND HUMAN SERVICES:

Digitally signed by Jeffrey Jeffrey S. s. Beach-$ Beach _

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CAPT GEORGE REED GRIMES, MD, MPH 0 : f o a t \ " ~-c\tltYll'.l Director, Division of Injury +1 itll Mterney A'!F.liSic:v\1 C:Xf"'("CT"O<J Compensation Programs Torts Branch Health Systems Bureau Civil Division. l lealth Resources and Services U.S. Oepartment of Justice Administration P.O. Box 146 U.S. Department of Health Benjamin Franklin Station and Human Services Washington, DC 20044-0146 5600 Fishers Lane, 14 W-1 R (202) 3S3 7722' btE,-~?J<;"') Rockville~MD 20857 alee.st~Ee@t,tsElej.ge¥ •

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