User:BD2412/Vaccine law resources/Vaccine injury compensation

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Vaccine Injury Compensation

• NCBI: Appendix E Vaccine-Injury Compensation in Other Countries

• Brian Kurt Copper II, “High and Dry?” The Public Readiness and Emergency Preparedness Act and Liability Protection for Pharmaceutical Manufacturers (mostly re: vaccines)

• Autism omnibus arguments page

• Special Master Dorsey

• Dorit Reiss, COVID-19 vaccine liability – what are the legal facts and limits (December 12, 2020)

The mere presence of a covered vaccine in a tort action is not sufficient to invoke the act. For example, a woman who was mistakenly given a flu vaccination by personnel at a federally-qualified community health center, rather than her prescribed Depo-Provera contraceptive shot, and who subsequently became pregnant and gave birth to a developmentally disabled child, was able to sue for negligence in the district court. Pacheco v. United States, Case No. C15-1175RSL (W.D. Wash., March 10, 2020)

• HHS proposal to remove SIRVA from the NVICP

• What Can Employers Do About Employees Who Refuse a Vaccine? (December 11, 2020) - notes that an employee who refuses employer instruction to receive the vaccine, and is then injured by the disease, will lose the Workers Comp. case.

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• HRSA Data & Statistics (2019)

CICP

• 42 CFR Part 110 RIN 0906–AA83 Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Final Rule
• 42 U.S.C. § 110.20 How to establish a covered injury

Gunter v. CCRC OPCO-Freedom Square, LLC, No. 8:20-cv-01546 (M.D. Fla., Oct. 20, 2020):

The PREP Act was enacted December 30, 2005, and "authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving "willful misconduct" as defined in the PREP Act. Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 FR 15198-01 (Dep't of Health and Human Svcs., Mar. 17, 2020). Effective February 4, 2020, the Secretary issued a Declaration to provide liability immunity for activities related to medical countermeasures against COVID-19. Id. The PREP Act defines "covered countermeasure" as a qualified pandemic or epidemic product, drug, biological product, or device. See 42 U.S.C. §§ 247d-6d(i)(1); 247d-6b(c)(1)(B); 247d-6d(i)(7). The term "covered person" under the PREP Act "when used with respect to the administration or use of a covered countermeasure means . . . a person or entity that is (i) a manufacturer of such countermeasure; (ii) a distributor of such countermeasure; (iii) a program planner of such countermeasure; (iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or (v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv)." 42 U.S.C. § 247d-6d(i)(2). The Act provides a civil remedy to compensate individuals through the Countermeasures Injury Compensation Fund for injuries resulting from the manufacture, testing, development, distribution, administration, or use of one or more Covered Countermeasures.

Novak

In Novak, an expert testified that plaintiff's death was "related" to a swine flu vaccination he received. Id. at 720. This medical opinion was based on the expert's assumption that the disease plaintiff suffered was caused by a virus. Tellingly, "no witness for the plaintiff could say with scientific or medical certainty that the particular vaccine at issue ... caused [plaintiff's] disorder." Id. at 722. Considered along with the defendant's expert testimony that there was no scientific evidence that the vaccine was related to the cause of plaintiff's illness, the United States Court of Appeals for the Sixth Circuit concluded that the district court clearly erred in upholding a finding of causation and entering judgment for the plaintiff. Id.

2020 Federal Circuit cases of interest

Dupuch-Carron v. HHS (Case No. 19-1596), decided August 11, 2020. Couple resided in the Bahamas, but visited the U.S. frequently, including while mother was pregnant. Child was vaccinated in the Bahamas, developed leukemia, brought to U.S. for treatment, eventually died. Question is whether the Bahamian-born child was "returning" to the U.S. when previously brought in utero. Court says no.

This court has jurisdiction to review the final judgment of the Claims Court under 42 U.S.C. § 300aa–12(f). In Vaccine Act cases, we review the Claims Court’s decision de novo, “applying the same standard of review as the Court of Federal Claims applied to its review of the special master’s decision.” Griglock v. Sec’y of Health & Hum. Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012) (citation omitted); see also Paluck v. Sec’y of Health & Hum. Servs., 786 F.3d 1373, 1378 (Fed. Cir. 2015). “We owe no deference to the trial court or the special master on questions of law, but we uphold the special master’s findings of fact unless they are arbitrary or capricious.” Lozano v. Sec’y of Health & Hum. Servs., 958 F.3d 1363, 1368 (Fed. Cir. 2020) (citing Griglock, 687 F.3d at 1374). “Thus, although we are reviewing as a matter of law the decision of the Court of Federal Claims under a nondeferential standard, we are in effect reviewing the decision of the Special Master under the deferential arbitrary and capricious standard on factual issues.” Griglock, 687 F.3d at 1374 (internal citations omitted). The Vaccine Act gives the Claims Court (and its special masters) jurisdiction “over proceedings to determine if a petitioner under section 300aa–11 of this title is entitled to compensation under the [Vaccine Injury Compensation] Program and the amount of such compensation.” Martin ex rel. Martin v. Sec’y of Health & Hum. Servs., 62 F.3d 1403, 1406 (Fed. Cir. 1995) (quoting 42 U.S.C. § 300aa– 12(a) (Supp. V 1993)).

The definition of “person” and “child” applicable to “any Act of Congress,” including the Vaccine Act, is “every infant member of the species homo sapiens who is born alive at any stage of development.” 1 U.S.C. § 8(a).

Appellants first allege that “[t]wo decisions from the Court of Federal Claims and a third from a special master have held that a child in utero is a ‘person’ for the purposes of the Vaccine Act.” Appellants’ Br. 46–47. In Rooks v. Sec’y of Dep’t of Health & Hum. Servs., Melton v. Sec’y of Dep’t of Health & Hum. Servs., and Burch v. Sec’y of Dep’t of Health & Hum. Servs.—the opinions cited by Appellants—the Claims Court and Special Masters were presented with the question of whether a child, whose mother received a vaccine while it was in utero, can be deemed to have also “received” the vaccine, such that they can petition for compensation under the Vaccine Act once born. See Rooks v. Sec’y of Dep’t of Health & Hum. Servs., 35 Fed. Cl. 1, 4 (1996) (stating “this case deals with the special master’s legal determination of the meaning of ‘received’ under the Vaccine Act” and finding “that the potential to ‘receive’ a vaccine while in utero exists”); Burch v. Sec’y of Dep’t of Health & Hum. Servs., No. 99-946V, 2010 WL 1676767 (Fed. Cl. Spec. Mstr. Apr. 9, 2010); Melton v. Sec’y of Dep’t of Health & Hum. Servs., No. 01-105V, 2002 WL 229781 (Fed. Cl. Spec. Mstr. Jan. 25, 2002). These cases do not state or imply, however, that those in utero are themselves “persons” that have a separate legal presence while traveling abroad for purposes of determining eligibility to seek compensation through the Vaccine Act.

Virginia Worker's Comp smallpox provision

Code of Virginia § 65.2-101. Definitions:

"Injury" means only injury by accident arising out of and in the course of the employment or occupational disease...

Such term shall include any injury, disease or condition:

...

2. Resulting from (a) the administration of vaccinia (smallpox) vaccine, Cidofivir and derivatives thereof, or Vaccinia Immune Globulin as part of federally initiated smallpox countermeasures, or (b) transmission of vaccinia in the course of employment from an employee participating in such countermeasures to a coemployee of the same employer.