Vaccines offer overwhelming public health benefits by helping reduce the spread of a number of dangerous, and sometimes fatal, communicable diseases. Following the recent development and release of various newly developed COVID-19 vaccines, approximately 112 million people, or roughly one-third of the total population of the United States, have been vaccinated as part of the global effort to try to curb the COVID-19 pandemic, and many more are being vaccinated every day.1
Unfortunately, some people who get vaccines, including the new COVID-19 vaccines, develop harmful side effects.2 For example, use of the COVID-19 vaccine developed by Johnson & Johnson recently was paused by the U.S. Food & Drug Administration and the Centers for Disease Control & Prevention for a short period to allow for the study of a very small number of reported cases of blood clots in some people who had received the vaccine.3 And some individuals who develop side effects will want to bring a legal claim for compensation. However, vaccine injury claims are handled differently than most medical injury claims.
As discussed in this article, most claims alleging injury from vaccines must be brought in specialized federal tribunals pursuant to federal statutes that generally preempt state law. This article discusses the current legal treatment of vaccine injury claims, among them claims related to COVID-19 vaccines, including the applicable statutory processes and case law.
The Vaccine Act: Procedures for Vaccine Injury Claims
The National Childhood Vaccine Injury Act of 1986 (hereinafter the Vaccine Act) establishes procedures for claims seeking compensation for bodily harm caused by vaccines.4 The Vaccine Act created the National Vaccine Injury Compensation Program to handle vaccine-related claims. The program is administered by a secretary who can compensate a party who has suffered a “vaccine-related injury or death.”5 The Act is intended “to free manufacturers from the specter of large, uncertain tort liability, and thereby keep vaccine prices fairly low and keep manufacturers in the market.”6 The Vaccine Act largely preempts traditional tort claims against vaccine administrators or manufacturers for vaccine-related injuries.7
Austin J. Malinowski, Marquette 2020, is a member of the Litigation Practice Group at O’Neil, Cannon, Hollman, DeJong & Laing S.C., Milwaukee. He assists clients with civil litigation matters, including contract, construction, real estate, and employment disputes. Get to know the author: Check out Q&A below.
Grant C. Killoran, Minnesota 1989, practices with O’Neil, Cannon, Hollman, DeJong & Laing S.C., Milwaukee. He is the past chair of the firm’s Litigation Practice Group and represents clients in Wisconsin state and federal courts, and courts throughout the country, with a focus on complex business and healthcare disputes. Get to know the author: Check out Q&A below.
The Vaccine Act bars claims for damages against a vaccine manufacturer or administrator8 of more than $1,000 or for an unspecified amount in state or federal courts and requires such claims to be filed with the U.S. Court of Federal Claims.9 This process has been described as creating the vaccine court. The Vaccine Act limits claimants to only those sustaining a vaccine-related injury or their legal representatives.10 Claimants are limited to a recovery of $250,000 for pain and suffering11 but may recover additional damages for actual and projected expenses that cannot be reimbursed, actual and anticipated lost earnings, and reasonable attorney fees and costs.12 The 36-month statute of limitation for claims under the Vaccine Act begins to run on the date of occurrence of the first alleged symptom.13
The Vaccine Act created a Vaccine Injury Table that lists vaccines and medical conditions that may result from them.14 (See sidebar for a sample listing.) Claimants must show by a preponderance of evidence that they suffered an injury listed in the table or that a vaccine caused or significantly aggravated their injury within the time periods set forth in the table.15 If claimants do so for an injury listed in the table within the time period stated in the table, they are presumed to be entitled to compensation.16 For claims not falling within the table, claimants must prove the vaccine at issue caused their injury by a preponderance of evidence.17
Vaccine court claims are sent to the office of the Chief Special Master, who then assigns the claim to a special master to review and issue a decision to be entered as a judgment by the Court of Federal Claims.18 Either party can request that the Court of Federal Claims review this decision and also can seek further review in the U.S. Court of Appeals for the Federal Circuit.19 Judicial review of the special masters’ decision is limited; the decision can be set aside only if either court determines it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”20 If claimants choose to reject a judgment by the vaccine court, they then may pursue a tort action in state or federal court.21 However, the Vaccine Act offers certain defenses and presumptions to defendants facing such claims.22
Approximately one person in one million who receives a vaccine will be compensated for a vaccine-related injury.23 Despite this exceedingly low percentage, the Vaccine Injury Compensation Program has paid out approximately $4.5 billion to claimants since its inception, with the vast majority of this compensation related to adverse reactions to influenza vaccines.24
Case Law on the Vaccine Act
The leading case on the scope of the Vaccine Act and its preemption of state law is the U.S. Supreme Court’s decision in Bruesewitz v. Wyeth.25 An infant, Hannah Bruesewitz, was given doses of the diphtheria-tetanus-pertussis (DTP) vaccine. Within 24 hours, she began experiencing numerous seizures and later was diagnosed with residual seizure disorder and developmental delay. Hannah’s parents filed a vaccine injury petition with the Court of Federal Claims alleging that Hannah’s injuries resulted from the DTP vaccine.26 The special master denied Hannah’s claims, but she nonetheless was awarded nearly $130,000 in attorney fees and costs. Hannah’s parents rejected this award and filed suit in the Pennsylvania state court alleging that the DTP vaccine had a defective design that caused Hannah’s injuries and seeking damages under theories of strict liability and negligent design-defect.27
After the case was removed to federal court, the case eventually made its way to the U.S. Supreme Court. When reviewing Hannah’s claims, the Court reviewed section 300aa-22(b)(1) of the Vaccine Act, which reads:
“No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”28
Writing for the majority, Justice Antonin Scalia found that because the words “even though” follow the word “unavailable” in the statutory text, the Vaccine Act “delineates the preventative measures that a vaccine manufacturer must have taken for a side effect to be considered ‘unavoidable’ under the statute.”29 The Court then ruled that the Vaccine Act preempted all state-law design-defect claims so long as there “was proper manufacture and warning.”30
Vaccine Injury Table – Sample Listing
The Vaccine Injury Table is lengthy and does not yet include a listing for the COVID-19 vaccines. Set forth below as an example is the table’s listing for influenza vaccine injury claims:
Illness, disability, injury, or condition covered
Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration
Seasonal influenza vaccines
Shoulder injury related to vaccine administration
(not less than 3 days and not more than 42 days)
Source: Health Res. & Servs. Admin., Vaccine Injury Table, (last visited May 9, 2021).
The PREP Act: Procedures for Claims Relating to Emergency Public Health Countermeasures
Like the vaccines that came before them, the various COVID-19 vaccines that recently have been made available to the public can cause some people who receive them to experience adverse effects.31 However, unlike claims for injury resulting from established vaccines, claims relating to the new COVID-19 vaccines cannot currently be brought before the vaccine court. That is because claims relating to emergency public health “countermeasures,” including vaccines, developed during a pandemic, epidemic, or national security threat are subject to the Public Readiness and Emergency Preparedness Act32 (hereinafter the PREP Act), not the Vaccine Act. The PREP Act established a different claims process, and designated its own forum, for certain vaccine-injury claims.
The PREP Act authorizes the U.S. Secretary of Health and Human Services (HHS) to issue a declaration, which may be amended and expanded at any time, providing immunity from all tort liability for covered persons from any loss “caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures.”33 To receive such immunity, a person or entity must show that 1) the individual or entity is a “covered person”; 2) the claim is for some sort of “loss”; 3) the loss is caused by a “covered countermeasure”; and 4) the product that caused the loss is a “covered countermeasure.”34 If these elements are met, immunity is granted.
The PREP Act defines a covered person as a person or entity that manufactures or distributes a countermeasure; is a program planner of a countermeasure; prescribes, administers, or dispenses a countermeasure; or is an official, agent, or employee of any of the persons or entities listed above.35 This definition is broad and appears to cover parties at every stage of the vaccine development, manufacturing, and distribution process.
A claim for a vaccine-related loss under the PREP Act must have a causal relationship to the “design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of a vaccine.”36 The scope of losses covered by the PREP Act is broad and includes all claims under state and federal law.37 The PREP Act thus appears to preempt the vast majority of state tort, medical malpractice, and wrongful death claims.38
The HHS declaration already has been amended many times to make the PREP Act applicable to public health efforts to address the COVID-19 pandemic. In December 2020, the HHS Secretary amended the declaration to cover “all qualified pandemic and epidemic products.”39 This expansion broadens the definition of covered countermeasures to include products used to enhance other products being used to treat and diagnose COVID-19 or treat a condition caused by other products being used to treat COVID-19.40 Other amendments have added respiratory protective devices; antivirals; and any vaccine used to treat, diagnose, cure, prevent or mitigate COVID-19 to the list of countermeasures covered by the PREP Act.41 The most recent amendment to the COVID-19 declaration expanded the definition of covered persons to include additional health-care professionals and students training in these health-care professions.42
Although the immunity provided by the PREP Act is broad, there is an exception. The PREP Act does not provide immunity for claims “for death or serious physical injury proximately caused by willful misconduct.”43 There is no immunity if an act or omission occurs “intentionally to achieve a wrongful purpose; knowingly without legal or factual justification; and in disregard of a known and obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.”44
Vaccine Injury Compensation Program
1 : 1,000,000
Persons compensated for vaccine-related injuries
Paid to claimants since 1988 (vast majority for influenza vaccine adverse reactions)
(Source: Health Res. & Servs. Admin., Data and Statistics 1 (2021).)
How to Claim Compensation under the PREP Act
Like the Vaccine Act, the PREP Act sets forth a specific process that must be followed in a specific tribunal to make a claim for compensation. A party first must seek compensation under the Countermeasures Injury Compensation Program (CICP), which is a “regulatory process administered by HHS’s Health and Services Administration.”45 A party has one year from the date of receipt of a vaccine (or other covered countermeasure) to request compensation under the CICP.46 If a request is made, and it is determined that a party has suffered a serious physical injury or death caused by a covered countermeasure, the CICP will reimburse the party for reasonable medical expenses, loss of employment income, and survivor benefits in the case of death.47 If this compensation is accepted, the party forfeits the option to bring a civil action under 42 U.S.C. § 247d-6d(d).48
If a party chooses to decline compensation from the CICP, however, that party may bring a claim in the U.S. District Court for the District of Columbia, regardless of where the harm occurred.49 The plaintiff must meet a heightened pleading standard and plead with particularity each act constituting willful misconduct.50 To prevail, the plaintiff must prove, by clear and convincing evidence, that willful misconduct caused the alleged injuries.51
The statute creates two defenses to a claim of willful misconduct: 1) if a covered person acts in accordance with “applicable directions, guidelines, or recommendations by the Secretary [of HHS] regarding the administration or use of a covered countermeasure” and notifies the Secretary, or a state or local health authority within seven days after the injury or death, there can be no willful misconduct; and 2) if the act or omission alleged to constitute willful misconduct is subject to regulation under either the Public Health Service Act or the Food, Drug, and Cosmetic Act, then the act or omission does not constitute willful misconduct if no enforcement action has been brought by the Secretary of HHS or the U.S. Attorney General and damages were not imposed.52 A plaintiff’s noneconomic damages, such as damages for pain and suffering and loss of enjoyment of life, also are limited.53
To date, few cases have been filed under the PREP Act relating to COVID-19. Because widespread public COVID-19 vaccination began only a few months ago, these cases have not involved vaccines. Rather, they have involved allegations that a covered party failed to use COVID-19 countermeasures, such as masks, gloves, and temperature checks, or failed to properly supervise and train staff members, leading to COVID-19 infections.54 Courts have been hesitant to apply PREP Act immunity to claims of alleged failure to use COVID-19 countermeasures, however.55
But one court made clear that PREP Act immunity likely will be granted in cases involving use of “any antiviral, any other drug, any biologic, any diagnostic any other device, or any vaccine” to “treat, diagnose, cure, prevent, or mitigate COVID-19.”56
Also of Interest
Quick Shot: Vaccination Guidance for Employers & Employees 2021
Ending the COVID-19 pandemic has required the biggest vaccination campaign in history. To date, one billion doses have been distributed worldwide, and vaccines continue to roll out as countries aim to quell outbreaks and return to “normalcy.” But what happens when not everyone wants to be vaccinated?
Can employers require their employees to be vaccinated? What if an employee raises a religious objection or a health care concern as their reason for refusing the vaccine? What if vaccinated employees have concerns about working alongside colleagues who aren’t vaccinated? Quick Shot: Vaccination Guidance for Employers and Employees will provide rapid answers to these questions and more.
Join presenter Erica N. Reib, a member of O’Neil, Cannon, Hollman, DeJong & Laing’s Labor and Employment Practice Group, for a full discussion. Presented by State Bar of Wisconsin PINNACLE.
- Webcast seminar: 1 CLE credit; members $89 | nonmembers $139
- Original webcast: Tuesday, June 15, 2021, 12:00 – 12:50 p.m. CT
- Webcast replays: Tuesday, June 15; Friday, June 25; Tuesday, June 29; Thursday, July 8; Wednesday, July 14; Monday, July 19; Tuesday, July 27; Thursday, August 5
For more information and to register, visit https://www.wisbar.org/CA3200.
Because of the importance of vaccines in protecting public health in the U.S., federal lawmakers have enacted statutes establishing special processes and designating specific tribunals to handle claims of injury caused by vaccines. They also have enacted laws limiting claims related to COVID-19 vaccines during our current national health emergency. And a number of states, including Wisconsin, have passed additional laws providing immunity to health-care providers and others for actions during the COVID-19 pandemic.57
Vaccine injury claims present both procedural and substantive challenges for plaintiffs. The statutory processes and protections established by the Vaccine Act make assessing the probability of recovery for vaccine-related injuries difficult. Moreover, lawmakers have enacted regulations prioritizing the development and deployment of COVID-19 medical countermeasures, including vaccines, over claims for harm stemming from those countermeasures. By doing so, American lawmakers have made clear the public policy calculus on vaccines during the current COVID-19 public health emergency.
» Cite this article: 94 Wis. Law. 22-28 (June 2021).
Meet Our Contributors
What is the most memorable trip you ever took?
The most memorable trip I’ve taken occurred just before the start of the COVID-19 lockdown. I traveled to Ireland and Northern Ireland with my international dispute resolution class at Marquette University Law School taught by Prof. Andrea Schneider. This trip was memorable for many reasons. First, I was able to visit many incredible places and landmarks and take in the history of both countries. This was my first time out of the United States, so I really enjoyed experiencing the different cultures and interacting with the people.
As I’m sure you can guess, the beginning of the pandemic also made this a memorable trip. There was about a 24-hour period when it was unclear whether we were going to be allowed to come back to the United States due to the COVID-related travel ban in place at the time. Although we were ultimately able to fly back as scheduled, the uncertainty definitely made for an interesting end to my first trip overseas.
Austin J. Malinowski, O’Neil, Cannon, Hollman, DeJong & Laing S.C., Milwaukee.
How do you spend your time outside the office?
For the most part, I spend my time away from work with my fantastic wife and our two wonderful teenage children and (before COVID) my friends. I also am involved in a number of professional and civic volunteer activities.
I particularly enjoy my work as a steering committee member and volunteer DJ at WMSE, 91.7 FM in Milwaukee and online at www.wmse.org. I have been a DJ there for more than 15 years, hosting a radio show every other Monday morning 6-9 a.m. during which I get to play music of my choosing.
I have been a DJ off and on for a long time. My high school in Green Bay had a small radio station, and I was a DJ there, and I was a DJ, music director, and general manager of my college radio station in St. Paul, Minn. I have little-to-no musical talent myself, but I love music and find that listening to music, doing a radio show, and going to see live music are fine ways to spend time outside of work.
Grant C. Killoran, O’Neil, Cannon, Hollman, DeJong & Laing S.C., Milwaukee.
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1 COVID-19 Vaccinations in the United States, CDC, https://covid.cdc.gov/covid-data-tracker/#vaccinations (last visited May 9, 2021).
2 See John Lauerman & Jason Gale, What to Know About Blood Clots, Anaphylaxis and Other Vaccine Fears, Bloomberg (Jan. 18, 2021; updated April 13, 2021), https://tinyurl.com/2uuxuytj.
3 Laurel Wamsley, U.S. Lifts Pause in Use of J&J Vaccine After Vote by Expert Panel, NPR (Apr. 23, 2021), https://tinyurl.com/cvuza44e.
4 42 U.S.C. §§ 300aa-1 to 300aa-34. Despite its official name, the Vaccine Act does not apply only to claims involving the vaccination of children. Also, and as is discussed later in this article, the Vaccine Act at present does not apply to injuries arising from COVID-19 vaccines because of the current national COVID-19 public health emergency.
5 42 U.S.C. § 300aa-10.
6 Schafer v. American Cyanamid Co., 20 F.3d 1, 4 (1st Cir. 1994).
7 See 42 U.S.C. § 300aa-11(2)(A); O’Connell v. Shalala, 79 F. 3d 170, 173 (1st Cir. 1996). But see Owens ex rel. Schaefer v. American Home Prods. Corp., 203 F. Supp. 2d 748 (S.D. Tex. 2002) (allowing claim against manufacturer of vaccine ingredient because it did not manufacture or administer vaccine).
8 The Vaccine Act was amended in late 2002 to include in the definition of a vaccine manufacturer companies making vaccine components or ingredients and to include, in the definition of vaccine,vaccine components and ingredients listed in a vaccine license application or on a vaccine label. See Homeland Security Act 2002, Pub. L. No. 107-296, § 1714.
9 42 U.S.C. § 300aa-11(a)(2)(A); see also Strauss v. American Home Prods. Corp., 208 F. Supp. 2d 711, 713-14 (S.D. Tex. 2002).
10 42 U.S.C. § 300aa-11(b)(1)(A).
11 42 U.S.C. § 300aa-15(a)(4).
12 See generally 42 U.S.C. § 300aa-15.
13 42 U.S.C. § 300aa-16(a)(2).
14 42 U.S.C. § 300aa-14.The U.S. Secretary of HHS may modify this table, including by adding or removing items. 42 U.S.C. § 300aa-14(c)(3).
15 Terran ex rel. Terran v. Secretary of HHS,195 F.3d 1302, 1307 (Fed. Cir. 1999).
16 Knutson v. Secretary of HHS, 35 F.3d 543, 547 (Fed. Cir. 1994).
17 Golub v. Secretary of HHS, No. 99-5161, 2000 WL 1471643, at *2 (Fed. Cir. Oct. 3, 2000) (unpublished).
18 42 U.S.C. § 300aa-11(a)(1), (a); (2)(A); 42 U.S.C. § 300aa-13(a)(1).
19 42 U.S.C. § 300aa-12(e)-(f).
20 See, e.g., Hanlon v. Secretary of HHS, 191 F.3d 1344, 1348 (Fed. Cir. 1999); Lampe v. Secretary of HHS, 219 F.3d 1357, 1360 (Fed. Cir. 2000).
21 See 42 U.S.C. § 300aa-12(e)-(f); 42 U.S.C. § 300aa-21(a).
22 For example, if a petitioner has established a prima facie case demonstrating entitlement to compensation, the government may rebut this case by establishing “[by] a preponderance of the evidence that the [petitioner’s injury] is due to factors unrelated to the administration of the vaccine described in the petition.” De Bazen v. Secretary of HHS, 539 F.3d 1347, 1352 (Fed. Cir. 2008) (citing 42 U.S.C. § 300aa-13(a)(1)(B)).
23 See Health Res. & Servs. Admin., Data and Statistics 1 (2021), www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/data/data-statistics-report.pdf.
24 Id. at 2-3. However, recent cases show that even a severe adverse reaction to an influenza vaccine does not necessarily lead to a successful claim for a significant monetary recovery.See, e.g., Murray v. Secretary of HHS, No. 19-424V, 2020 WL 7867300 (Fed. Cl. Dec. 7, 2020) (holding that Murray failed to establish by preponderance of evidence that influenza vaccine caused her injuries because she failed to present an expert establishing causation); Grow v. Secretary of HHS, No. 16-13V, 2020 WL 7366332 (Fed. Cl. Nov. 24, 2020) (despite Grow presenting expert physician to establish that influenza vaccine caused his injuries, denying Grow’s claim because he failed to establish his injuries occurred after influenza vaccination occurred, among other reasons); Bailey v. Secretary of HHS, 151 Fed. Cl. 396 (2020) (finding that Bailey failed to establish that he was suffering from Guillain-Barré syndrome and not amyotrophic lateral sclerosis and failed to show that influenza vaccine caused his amyotrophic lateral sclerosis).
26 Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011).
26 Id. at 230.
27 Id. at 230-31.
30 Id. at 232.
31 See Helen Branswell, The Curse of the Incidental Illness: Seen as Side Effects to Covid Vaccinations, Ailments May have Little to do With Them, STAT (Dec. 28, 2020), https://tinyurl.com/223x2atw.
32 Codified at 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e.
33 85 Fed. Reg. 21,012 (Apr. 15, 2020).
34 CRS Legal Sidebar, The PREP Act and COVID-19; Limiting Liability for Medical Countermeasures, Congressional Rsch. Serv. (Dec. 21, 2020), https://crsreports.congress.gov/product/pdf/LSB/LSB10443.
35 See 42 U.S.C. § 247d-6d(i)(2).
36 42 U.S.C. § 247d-6d(a)(2)(B).
37 CRS Legal Sidebar, supra note 34.
39 85 Fed. Reg. 79,190 (Dec. 9, 2020).
40 Erik K. Swanholt et al., HHS Expands and Clarifies Scope of Immunity Under the PREP Act, Nat’l L. Rev. (Dec. 28, 2020), www.natlawreview.com/article/hhs-expands-and-clarifies-scope-immunity-under-prep-act.
41 See 85 Fed. Reg. 21,012 (Apr. 15, 2020); 85 Fed. Reg. 35,100 (June 8, 2020); 85 Fed. Reg. 52,136 (Aug. 24, 2020), 85 Fed. Reg. 79,190 (Dec. 9, 2020); 86 Fed. Reg. 7872 (Feb. 2, 2021); 86 Fed. Reg. 9516 (Feb. 16, 2021). Links to all of the amendments to the HHS declaration relating to COVID-19 can be found on the HHS Public Health Emergency website, www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.
42 See 86 Fed. Reg. 14,462 (Mar. 16, 2020).
43 42 U.S.C. § 247d-6d(d)(1).
44 42 U.S.C. § 247d-6d(c)(1)(A)
45 CRS Legal Sidebar, supra note 34.
46 Health Res. & Servs. Admin., Filing for Benefits, www.hrsa.gov/cicp/filing-benefits (last reviewed Jan. 21, 2021).
47 CRS Legal Sidebar, supra note 34.
48 42 U.S.C. § 247d-63(d)(5).
49 42 U.S.C. § 247d-6d(e)(1).
50 42 U.S.C. § 247d-6d(e)(3).
51 CRS Legal Sidebar, supra note 34.
52 See 42 U.S.C. § 247d-6d(c)(4), (5).
53 42 U.S.C. § 247d-6d(e)(8).
54 See, e.g., Sherod v. Comprehensive Healthcare Mgmt. Servs., LLC, No. 20CV1198, 2020 WL 6140474 (W.D. Pa. Oct. 16, 2020) (slip copy) (appeal filed).
55 Id; see also Fortune v. Big Blue Healthcare, Inc., No. 2:20-CV-2318-HLT-JPO, 2020 WL 4815097 (D. Kan. Aug. 19, 2020) (slip copy).
56 Estate of Maglioli v. Andover Subacute Rehab. Ctr. I, 478 F. Supp. 3d 518, 525 (D.N.J. 2020); but see Lyons v. Cucumber Holdings LLC, No. CV2010571JFWJPRX, 2021 WL 364640, *4 (C.D. Cal. Feb. 3, 2021) (slip copy) (appeal filed) (“there is only immunity for ‘inaction claims’ when the failure to administer a covered countermeasure to one individual has ‘a close causal relationship’ to the administration of that covered countermeasure to another individual”).
57 See, e.g.,2019 Wis. Act 185, 2021 Wis. Act 4.