Solving the Pandemic Vaccine Product Liability Problem

UC Irvine Law Review UC Irvine Law Review

Volume 12 Issue 1 Article 7

11-2021

Solving the Pandemic Vaccine Product Liability Problem Solving the Pandemic Vaccine Product Liability Problem

Sam F. Halabi

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Sam F. Halabi,

Solving the Pandemic Vaccine Product Liability Problem

, 12 U.C. IRVINE L. REV. 111 (2021).

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111

Solving the Pandemic Vaccine Product

Liability Problem

Sam F. Halabi*

The global rollout of COVID-19 vaccines is underway, and with it the inevitable

occurrence of severe side effects that accompany, rarely, even the safest and most effective

vaccines. Governments have invested billions of dollars in supporting research, development,

logistics, and supply chains, as well as supporting the creation of networks of healthcare

providers to deliver vaccines to recipients all over the world. The European Commission and

several international organizations have established the COVAX Facility to pool resources

in promising vaccine candidates and to subsidize their procurement by low- and middle-income

countries. Yet up-front investment in vaccine development and delivery solves only half the

problem with respect to vaccine access. Risks of legal liabilities, particularly product liability

for severe side effects, will serve as an important, if not decisive, factor in how vaccine

manufacturers participate in the response with Emergency Use Authorized and

recently-licensed COVID-19 vaccines. If manufacturers do not receive sufficient assurance

against legal liability, especially product liability, they will not ship vaccines. There is limited

experience with developing coronavirus vaccines, and severe side effects following immunization

are inevitable, as evidenced from Phase III trials and strongly suggested by early

administration of Emergency Use Authorized vaccines. Therefore, there is a critical need to

balance the risk calculations of manufacturers with justice for immunization recipients who

become seriously ill or die in order to contribute to herd immunity in the community. This

Article outlines the components of a global no-fault liability, indemnification, and

compensation system that includes leveraging current no-fault systems in thirty-nine countries,

a World Health Organization insurance mechanism, and a combination of insurance and

compensation fund construction based on claims-processing precedents from the Deepwater

* Senior Scholar and Visiting Professor, O’Neill Institute for National and Global Health Law,

Georgetown University; Professor, Colorado School of Public Health and Senior Associate

Vice-President for Health Policy and Ethics, Colorado State University; JD Harvard, MPhil Oxford, BS

Kansas State University. This Article was supported by the C. Boyden Gray Center for the Study of the

Administrative State at George Mason University. The author thanks organizers of the University of

Iowa Faculty Workshop Series and extends special thanks to the following for significant comments

on earlier drafts: Ann Laquer Estin, Tom Gallanis, Roger Klein, Erika Lietzan, César Rosado Marzán,

Tony Mills, Todd Pettys, Anya Prince, Ana Santos Rutschman, Sean Sullivan, Cristina Tilley, Andrew

Torrance, Dan Troy, Adam White, Richard Williams, and Patti Zettler. The author thanks Audrey

Honert, Tim Richard, and Shuwen Xu for superb research assistance.

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112 UC IRVINE LAW REVIEW [Vol. 12:111

Horizon Oil Spill and Boeing 737 Max crashes—both of which had tens of thousands of

claims originating from dozens of countries and processed in at least six languages. The

proposed system will be essential for vaccine manufacturer response and to address vaccine

hesitancy and injury in populations across the globe.

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 113

Introduction ..................................................................................................................... 114

I. COVID-19 Vaccines and Product Liability ................................................... 119

A. The Uniqueness of Vaccines as Regulated Medical Products ........... 119

1. Premarket Review ............................................................................. 119

2. Tort Liability as a Regulatory Mechanism ..................................... 121

B. Product Liability and COVID-19 Vaccines ......................................... 123

1. Real and Unknown Risks ................................................................. 123

a. New Vaccine Technologies ...................................................... 123

b. Side Effects Following Phase III and EUA COVID-19

Vaccines ....................................................................................... 125

c. H1N1 ........................................................................................... 126

d. Dengue ......................................................................................... 129

2. Perceived and Falsely Attributed Risks ......................................... 132

C. Informed Consent and Product Labeling ............................................ 134

II. Global Pandemic Response Depends on Fairness to Those Suffering

Severe Side Effects Following Immunization and Legal Assurance to

Manufacturers ..................................................................................................... 137

A. The Structure of the COVAX Facility .................................................. 138

B. Liability and Compensation for Vaccine Injury Pose Barriers to

both Manufacturer and Government Participation in COVAX ...... 145

C. Principles of Fairness and Justice Require Compensation for

Those Suffering from Severe Adverse Events Following

Immunization with COVID-19 Vaccines ............................................ 146

III. Solving the COVID-19 Vaccine Product Liability Problem ...................... 148

A. No-Fault Compensation for Vaccine Injury ........................................ 148

1. No-Fault Compensation Systems for Public Health

Emergencies ....................................................................................... 148

2. Adapting No-Fault Compensation Systems for Routine

Immunizations ................................................................................... 151

a. Funding ........................................................................................ 151

b. Eligibility ...................................................................................... 152

c. Administration ............................................................................ 153

d. Limits on Compensation ........................................................... 153

B. Expanding Small-Scale Insurance Plans ............................................... 154

C. Centralized Mass Claims Administration ............................................. 156

1. Deepwater Horizon Oil Spill .......................................................... 156

2. Boeing 737 Max Crash Compensation System ............................ 159

Conclusion ....................................................................................................................... 161

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114 UC IRVINE LAW REVIEW [Vol. 12:111

NTRODUCTION

The world’s greatest mass vaccination campaign is underway.

Since the first

COVID-19 vaccines were authorized in the United Kingdom, approximately

hundreds of millions of doses have been administered, with billions more planned.

Vaccines are the most important public health intervention to prevent the spread

of infectious disease, and, as a result, the whole world is racing to deploy a safe and

effective vaccine against COVID-19.

As of August 15, 2021, there are 179 vaccine

candidates in pre-clinical and clinical development, thirty-three of which are in

Phase III trials.

As of February 27, 2021, the U.S. Food and Drug Administration

(FDA) had granted Emergency Use Authorization (EUA) for Moderna/NIH’s,

Pfizer/BioNTech’s, and Johnson & Johnson’s vaccines.

Pfizer/BioNTech’s was

given full licensure on August 23, 2021. The United Kingdom’s Medicines and

Healthcare products Regulatory Agency has approved those vaccines plus

AstraZeneca’s candidate for full licensure.

Additional vaccine candidates from

1. German Lopez, The Covid-19 Vaccine’s 2 Big Challenges, VOX (Dec. 14, 2020, 8:00 AM),

https://www.vox.com/future-perfect/22161047/covid-19-coronavirus-vaccine-manufacturing-distribution

-persuasion [ https://perma.cc/Q2XJ-XYSY] (“This is going to be the largest mass vaccination

campaign that the US has ever attempted.”).

2. Tom Randall, Cedric Sam, Andre Tartar, Paul Murray & Christopher Cannon, More than 4.13

Billion Shots Given: Covid-19 Tracker,

BLOOMBERG, https://www.bloomberg.com/graphics/covid-

vaccine-tracker-global-distribution/ [http://web.archive.org/web/20210802000047/https://www.

bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/] (Aug 1, 2021, 2:53 PM).

3. Press Release, World Health Org., More than 150 Countries Engaged in COVID-19 Vaccine

Global Access Facility ( July 15, 2020), https://www.who.int/news-room/detail/15-07-2020-more-

than-150-countries-engaged-in-covid-19-vaccine-global-access-facility [https://perma.cc/F6FM-

8TDK ]. See generally Sam F. Halabi & Saad B. Omer, Evidence, Strategies, and Challenges for Assuring

Vaccine Availability, Efficacy, and Safety, in G

LOBAL MANAGEMENT OF INFECTIOUS DISEASE AFTER

EBOLA 223 (Sam F. Halabi, Lawrence O. Gostin & Jeffrey S. Crowley eds., 2016).

4. Trefis Team, What to Expect as Moderna’s COVID-19 Vaccine Moves to Phase 3 Trials,

ORBES ( July 29, 2020, 9:30 AM), https://www.forbes.com/sites/greatspeculations/2020/07/29/

what-to-expect-as-modernas-covid-19-vaccine-moves-to-phase-3-trials/?sh=7c049f761e96 [https://

perma.cc/CT5M-GZ9F ] (“These trials will determine if the vaccine protects against Covid-19 and

whether it will be cleared for use in the general public. Patients who recover from Covid-19 generate

antibodies that help to prevent re-infection and per interim data from its phase 1 trials that involved 45

people, Moderna said that the people inoculated with the vaccine generated antibodies that were 4x

compared to people who’d recovered from Covid. The phase 3 trial will help to validate this at a larger

scale and is expected to enroll 30,000 participants in the U.S.”); Carl Zimmer, Jonathan Corum

& Sui-Lee Wee, Coronavirus Vaccine Tracker, N.Y.

TIMES, https://www.nytimes.com/interactive/

2020/science/coronavirus-vaccine-tracker.html [https://perma.cc/PNS7-AXUK] (Aug. 2, 2021).

5. Press Release, Pfizer, Pfizer and BioNTech to Submit Emergency Use Authorization

Request Today to the U.S. FDA for Covid-19 Vaccine, (Nov. 20, 2020, 6:45AM), https:/

www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use

-authorization [https://perma.cc/XLT4-F87R]; Press Release, Moderna, Moderna Announces

Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing

Today with U.S. FDA for Emergency Use Authorization (Nov. 30, 2020), https://

investors.modernatx.com/node/10421/pdf [https://perma.cc/65AC-RCPY ].

6. Michael Mezher, MHRA Authorizes Pfizer-BioNTech COVID Vaccines as FDA, EMA Set

more Conservative Timeline, R

EGUL. AFFS. PROS. SOC’Y (Dec. 2, 2020), https://www.raps.org/news-

and-articles/news-articles/2020/12/mhra-authorizes-pfizer-biontech-covid-vaccine-as-f [ http://web.

archive.org/web/20201212100540/https://www.raps.org/news-and-articles/news-articles/2020/12/

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 115

Novavax and others are entering regulatory review for EUA. The World Health

Organization has granted emergency use listing to those vaccines in addition to

Sinopharm and Sinovac vaccines.

Wealthy governments have already invested billions of dollars in the effort to

bring more vaccine candidates to licensure, or at least EUA.

Many countries are

attempting to secure access to vaccines by offering funding to scale-up

manufacturing and assisting with clinical trials.

The Global Alliance for Vaccines

and Immunizations (GAVI), an international vaccine procurement consortium

aiding low-income countries, is pursuing a similar strategy for securing equitable

access to COVID-19 vaccines.

The Coalition for Epidemic Preparedness

Innovations (CEPI), an international financing partnership, has supported at least

ten candidates, including Moderna’s.

Instead of waiting until after vaccines are

approved and then bidding for them, GAVI, CEPI, the World Health Organization

(WHO), and the European Commission, as well as a number of global health

charities, have developed the “COVAX Facility,” an international organization

aimed at procuring vaccine doses for all its participating governments, including

subsidies for the purchase of vaccines by low- and middle-income countries.

Governments have entered into bilateral arrangements to lay claim to early

production. For example, AstraZeneca has received payments from the United

Kingdom (U.K.), the United States, and the Serum Institute of India, and in return

has promised delivery of 100 million doses, delivery of 300 million doses, and

mhra-authorizes-pfizer-biontech-covid-vaccine-as-f]; Pfizer-BioNTech COVID-19 Vaccine,

U.S. FOOD & DRUG ADMIN., https://www.fda.gov/emergency-preparedness-and-response/

coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine [http://web.archive.org/web/

20210723073821/https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-

2019-covid-19/pfizer-biontech-covid-19-vaccine] (last visited July 23, 2021).

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process, World Health

Org. (Sept. 29, 2021), https://extranet.who.int/pqweb/sites/default/files/documents/Status_

COVID_VAX_29Sept2021_0.pdf [https://perma.cc/73YJ-2VDW].

8. See generally Matthew Herper, AstraZeneca Lays Out Plan for Producing 2 Billion Doses of

Covid-19 Vaccine, if It Works, STAT ( June 4, 2020), https://www.statnews.com/2020/06/04/

astrazeneca-lays-out-plan-for-producing-2-billion-doses-of-covid-19-vaccine-if-it-works/ [https://

perma.cc/98K4-X8JL ].

9. Id.

10. Press Release, Gavi, the Vaccine Alliance, Gavi Launches Innovative Financing Mechanism

for Access to COVID-19 Vaccines ( June 4, 2020), https://www.gavi.org/news/media-room/gavi-

launches-innovative-financing-mechanism-access-covid-19-vaccines [https://perma.cc/ZY9T-9FNB].

11. Press Release, World Health Org., COVAX Announces Additional Deals to Access

Promising COVID-19 Vaccine Candidates; Plans Global Rollout Starting Q1 2021 (Dec. 18, 2020)

[hereinafter WHO, COVAX Announces Additional Deals], https://www.who.int/news/item/18-12-

2020-covax-announces-additional-deals-to-access-promising-covid-19-vaccine-candidates-plans-global

-rollout-starting-q1-2021 [https://perma.cc/M6FM-KPXX ].

12. Id.; Press Release, Gavi, the Vaccine Alliance, Up to 100 Million COVID-19 Vaccine Doses

to Be Made Available for Low- and Middle-Income Countries as Early as 2021

(Aug. 7, 2020),

https://www.gavi.org/news/media-room/100-million-covid-19-vaccine-doses-available-low-and-middle

-income-countries-2021 [ https://perma.cc/Q4CH-RFMA ].

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116 UC IRVINE LAW REVIEW [Vol. 12:111

assistance in producing 1 billion doses, respectively.

However, there are far fewer

details on what happens after the doses arrive.

While ex ante investment in the development of vaccines, manufacturing

capacity, and related material like vials and syringes is critical, so too is the ex post

consideration of what happens should emergency-authorized or fully licensed

vaccines cause significant side effects. Most of the leading COVID-19 vaccine

candidates are based on technologies unlicensed anywhere in the world, and the

potential for sizable product liability claims is significant.

On December 8, 2020,

the first day of the U.K. vaccination campaign, two severe allergic reactions caused

the U.K. government to require monitoring patients for fifteen minutes after each

injection.

In the United States, the Centers for Disease Control and Prevention

(CDC) has detected twenty-one anaphylactic reactions to COVID-19 vaccines out

of nearly 1.9 million doses administered, a rate of approximately 11.1 severe reaction

13. Herper, supra note 8.

14. Eileen Drage O’Reilly, The Coming Clash Over the First Coronavirus Vaccines, AXIOS

(Apr. 30, 2020), https://www.axios.com/coronavirus-vaccine-supplies-availability-16264fa9-ccd5-

4705-abd5-6d208e864ba9.html [ https://perma.cc/V7ZD-2Q6H] (“There will not be enough vaccines

to meet initial demand, experts say. That’s left nations racing to secure future supplies and international

organizations scrambling to make sure there is equitable access to any vaccines for the novel

coronavirus. . . . The COVID-19 vaccine race is underway, with at least 92 in development and more

expected. They’re based on different approaches that have different manufacturing processes. There

are a limited number of facilities that are large enough for massive scale-ups and/or are flexible enough

to switch to a different type of vaccine than they were originally intended to produce. Over the next

several months, there’s expected to be a ‘winnowing’ of these potential vaccines as data from initial

trials are collected, but it will take time before it’s known which vaccine(s) are best, according to a group

of experts at a press briefing hosted by the nonprofit ONE on Thursday. Having a global dialogue

now on how vaccines should be scaled up and distributed is key, experts say.”); Costas Paris & Jared

S. Hopkins, Pfizer Sets Up Its ‘Biggest Ever’ Vaccination Distribution Campaign, W

ALL ST. J. (Oct. 21,

2020, 6:13 AM), https://www.wsj.com/articles/pfizer-sets-up-its-biggest-ever-vaccination-

distribution-campaign-11603272614 [ https://perma.cc/DJF5-TC5Q] (“[T]he biggest complications

in distribution likely would come closer to the final point of delivery rather than the first stages of

shipping.”); Jared S. Hopkins, Covid-19 Vaccines to Be Stored Secretly Under Tight Security, W

ALL

ST. J. (Oct. 21, 2020, 3:48 PM), https://www.wsj.com/articles/covid-19-vaccines-to-be-stored-

secretly-under-tight-security-11603278002?mod=hp_lead_pos4 [https://perma.cc/6ULY-S4BC]

(detailing the complications of vaccine theft and possible precautions that will be taken to hopefully

protect the COVID-19 vaccine from theft).

15. John Parkinson, FDA Fast Tracks 2 COVID-19 Vaccines, C

ONTAGIONLIVE ( July 13,

2020), https://www.contagionlive.com/view/fda-fast-tracks-2-covid19-vaccines [https://perma.cc/

A4KW-NXM8 ].

16. Joanna Sugden, Rollout of Pfizer-BioNTech Covid-19 Vaccine Slows in U.K. Due to

Allergic-Reaction Monitoring, W

ALL ST. J. (Dec. 14, 2020, 12 46 PM), https://www.wsj.com/articles/

rollout-of-pfizer-biontech-covid-19-vaccine-slows-in-u-k-due-to-allergic-reaction-monitoring-116079

67990 [https://perma.cc/VHU5-VMPK ].

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 117

cases per million.

AstraZeneca and Johnson & Johnson vaccines have been

associated with rare blood-clotting disorders.

Although the United States has granted immunity to COVID-19 vaccine

manufacturers pursuant to its Public Readiness and Emergency Preparedness Act

(PREP Act),

and manufacturers are securing “protection from future product

liability claims” where possible on a bilateral basis, there remains no comprehensive

plan for the potentially massive claims related to product liability.

For one or more vaccines likely to be distributed worldwide, there is inevitable

risk of serious adverse events. For the H1N1 pandemic vaccine, the only vaccine

distributed pursuant to a declared pandemic, serious adverse events following

immunization varied widely. Among those reported in the United States through its

Vaccine Adverse Event Reporting System, the H1N1 pandemic vaccine produced

a serious adverse event rate of 2.45 per 100,000.

In the People’s Republic of China,

the National Adverse Events Following Immunization (AEFI) Surveillance System

reported that a

total of 6552 of the 8067 adverse events there (81.2%; rate, 73.1 per 1

million doses) were verified as vaccine reactions; 1083 of the 8067 (13.4%;

rate, 12.1 per 1 million doses) were rare and more serious (vs. common,

minor events), most of which (1050) were allergic reactions. Eleven cases

of the Guillain–Barré syndrome were reported, for a rate of 0.1 per 1

million doses.

17. Tom Shimabukuro, Allergic Reactions Including Anaphylaxis After Receipt of the First Dose

of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020, 70 MORBIDITY

MORTALITY WKLY. REP. 46, 46–51 ( 2021), https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/

mm7002e1-H.pdf [ https://perma.cc/W6GN-GWYM ].

18. EUR. CTR. FOR DISEASE PREVENTION & CONTROL, TECHNICAL REPORT, OVERVIEW OF

EU/EEA COUNTRY RECOMMENDATIONS ON COVID-19 VACCINATION WITH VAXZEVRIA, AND A

SCOPING REVIEW OF EVIDENCE TO GUIDE DECISION-MAKING 1 (2021), https://

www.ecdc.europa.eu/sites/default/files/documents/Overview%20EU%20EEA%20country%20reco

mmendations%20on%20COVID-19%20vaccination%20Vaxzevria%20and%20scoping%20review%

20of%20evidence.pdf [https://perma.cc/X3AC-3KBE]; Press Release, U.S. FDA, FDA and CDC Lift

Recommended Pause on Johnson & Johnson ( Janssen) COVID-19 Vaccine Use Following Thorough

Safety Review (Apr. 23, 2021), https://www.fda.gov/news-events/press-announcements/fda-and-cdc-

lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough [https://

perma.cc/F892-N537 ].

19. 42 U.S.C. § 247d-6d.

20. Ludwig Burger & Pushkala Aripaka, AstraZeneca to be Exempt from Coronavirus Vaccine

Liability Claims in Most Countries, REUTERS ( July 30, 2020, 6:19 AM), https://www.reuters.com/

article/us-astrazeneca-results-vaccine-liability/astrazeneca-to-be-exempt-from-coronavirus-vaccine

-liability-claims-in-most-countries-idUSKCN24V2EN [https://perma.cc/5L9F-QP3F].

21. Barbara H. Bardenheier, Susan K. Duderstadt, Renata J.M. Engler & Michael M. McNeil,

Adverse Events Following Pandemic Influenza A (H1N1) 2009 Monovalent and Seasonal Influenza

Vaccinations During the 2009-2010 Season in the Active Component U.S. Military and Civilians Aged

17-44 Years Reported to the Vaccine Adverse Event Reporting System, 34 V

ACCINE 4406, 4408 (2016).

22. Xiao-Feng Liang, Da-Wei Liu, Wen-Di Wu, Bao-Ping Zhu, Hua-Qing Wang, Hui-Ming

Luo, Ling-Sheng Cao, Jing-Shan Zheng, Da-Peng Yin, Lei Cao, Bing-Bing Wu, Hong-Hong Bao,

Di-Sha Xu, Wei-Zhong Yang & Yu Wang, Safety of Influenza A (H1N1) Vaccine in Postmarketing

Surveillance in China, 364 N. E

NG. J. MED. 638, 638 (2011).

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118 UC IRVINE LAW REVIEW [Vol. 12:111

Compensation costs similarly varied.

One specific H1N1 pandemic vaccine

that contained an adjuvant was associated with an increased risk of narcolepsy,

resulting in significant compensation claims in Northern European countries.

Solving the vaccine injury problem is crucial not only for populations injured

by serious adverse events following immunization but also for the companies that

may not participate in the response at all if not given sufficient assurances of

immunity or indemnity and for governments with populations that may be

disadvantaged because their internal legal systems do not allow the immunities or

indemnities to be arranged through bilateral contracts (i.e., there must be a

legislative measure undertaken). This Article outlines the components of a global

system, leveraging currently existing no-fault vaccine injury compensation systems

in thirty-nine countries, private-sector insurance alternatives based on a proposed

program at the WHO, and a centralized mass claims system based on models for

compensation from the Deepwater Horizon oil spill and the Boeing 737 Max

airplane crashes, both of which involved hundreds or thousands of claimants from

dozens of countries.

Part I of this Article analyzes the legal landscape for vaccine regulation

including premarketing review by regulatory agencies and postmarketing regulation

through product liability claims. Part I also uses specific aspects of COVID-19

vaccine technology and recent mass vaccination episodes to contextualize the scale

of potential liability as well as the potentially significant lifelong costs imposed on

those suffering rare but serious side effects after immunization. Part II introduces

and details the COVAX Facility, an international partnership that aims to procure

vaccine doses for low- and lower-middle-income countries unable to afford them.

However, the COVAX Facility has not addressed the COVID-19 vaccine product

liability problem, which is likely to thwart the vaccine’s effectiveness. Part III

provides a three-part plan for no-fault vaccine injury compensation based on

leveraging existing, national no-fault systems; small-scale insurance regimes; and

mass claims models based on human-caused disasters.

23. Id.

24. Ian Sample, Ministers Lose Fight to Stop Payouts Over Swine Flu Jab Narcolepsy Cases,

GUARDIAN (Feb. 9, 2017, 5:56 AM), https://www.theguardian.com/science/2017/feb/09/ministers-

lose-fight-to-stop-payouts-in-swine-flu-jab-narcolepsy-cases [https://perma.cc/D3MP-5PGF ]; Rory

Carroll, Swine Flu Vaccine Case Settled but Hopes for Legal Precedent Dashed, G

UARDIAN (Nov. 19,

2020, 08:35 AM), https://www.theguardian.com/world/2019/nov/20/swine-flu-vaccine-case-

settled-but-hopes-for-legal-precedent-dashed [ https://perma.cc/4Z9Y-FQA3 ].

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 119

COVID-19 VACCINES AND PRODUCT LIABILITY

A. The Uniqueness of Vaccines as Regulated Medical Products

1. Premarket Review

Legally and medically, vaccines are sui generis. Despite their immense value in

terms of lives saved and resources preserved—between 1980 and 2018, the WHO

estimates vaccines have saved 150 to 200 million lives and avoided $586 billion in

costs of illness—they are medicines given to otherwise healthy people to prevent

disease.

Like all medicines, vaccines carry risks of side effects, from the minor and

common (like soreness at the injection site) to the severe and rare, such as allergic

reactions and Guillain-Barré syndrome (a condition in which the body’s immune

system attacks peripheral nerves), that may result in disability or death.

The potential for vaccines to cause harm in otherwise healthy people is the

reason that most countries and international organizations look to scientific review

agencies to verify the soundness of animal and human testing data, quality control

of manufacturing facilities, and clarity of product information provided with the

immunization. The U.S. FDA and the European Medicines Agency are two of the

most important of these review agencies, and they provide services not only for the

populations under their territorial authority but also for international organizations

that procure vaccines for countries without the ability to undertake their own

regulatory review.

The FDA’s Center for Biologics Evaluation and Research is responsible for

regulating vaccines in the United States, and its approval facilitates the use of

25. Samantha Vanderslott, Bernadeta Dadonaite & Max Roser, Vaccination, OUR WORLD IN

DATA n.3 (2015) (“UNICEF (1996) and Hinman, A. R. (1998) estimate that in the absence of a vaccine

the world would have seen 5 million deaths due to smallpox every year in the mid-1990s. Assuming

that the estimate for the mid-1990s provides a midpoint estimate for the period since 1980 and therefore

multiplying the 5 million per year estimate by the number of years between 1980 and 2016 means that

since the eradication of the disease 190 million people’s lives were saved. UNICEF (1996) – Vaccines

bring 7 diseases under control.”). See generally Sachiko Ozawa, Samantha Clark, Allison Portnoy, Simrun

Grewal, Logan Brenzel & Damian G. Walker, Return on Investment From Childhood Immunization in

Low- and Middle-Income Countries, 2011-20, 35 HEALTH AFFS. 199 (2016); Anya E.R. Prince, Prevention

for Those Who Can Pay: Insurance Reimbursement of Genetic-Based Preventative Interventions in the Liminal

State Between Health and Disease, 2

J.L. & BIOSCIENCES 365, 369 (2015) (“Public health literature

references prevention by type—primary, secondary, and tertiary. Primary prevention occurs before a

disease manifests through symptoms or biological changes. A common example is vaccination to

protect against certain infectious childhood diseases. Whereas primary prevention reduces both

incidence and prevalence of a condition because it blocks an individual from getting a disease, secondary

prevention occurs after biological changes have arisen in an individual but reduces disease severity by

preventing progression or mortality.”).

26. Sam F. Halabi & Saad B. Omer, A Global Vaccine Injury Compensation System, 317 JAMA

471, 471 (2017); Richard A.C. Hughes & David R. Cornblath, Guillain-Barré Syndrome, 366 L

ANCET

1653, 1653 (2005).

27. See generally Sam Halabi & John Monahan, Regulatory Capacity in Low- and Middle-Income

Countries: Lessons from the H1N1 Influenza Pandemic, in F

OOD AND DRUG REGULATION IN AN ERA

GLOBALIZED MARKETS 63 (Sam Halabi ed., 2015).

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120 UC IRVINE LAW REVIEW [Vol. 12:111

vaccines in countries that lack regulatory capacity.

The vaccine clinical

development process—including that of COVID-19 vaccines—follows the same

general pathway as for drugs and other biologics.

As researchers identify and isolate the relevant pathogen, they seek to

understand, to the greatest extent possible, the biological mechanism or

mechanisms that lead to disease.

While some candidate vaccines occur naturally

(like that for smallpox), most candidates are developed using empirical

approaches: historically, serial propagation of a pathogen through media that

diminishes pathogenicity, or that is killed or dissected after cultivation and used in

relatively large doses, with adjuvants or in multiple doses to prompt an immune

response.

More recent techniques like “reverse vaccinology” start from genomic

sequences and, by computer simulation, predict those antigens that are most likely

to be vaccine candidates.

Vaccine candidates are then tested in animals after

developing models for immunogenicity and safety.

After animal testing, the vaccine sponsor applies for Investigational New Drug

(IND) status from the U.S. FDA, which authorizes the sponsor to undertake clinical

trials on humans for safety and efficacy and, ultimately, to build the evidentiary case

for licensure.

The first of these trials (Phase I) is designed to assess the safety,

immunogenicity, and dose-response of the vaccine in, typically, 20–100 healthy

volunteers.

The IND describes the vaccine, its method of manufacture and quality

control tests for release, information about the vaccine’s safety and ability to prompt

a protective immune response in animal testing, and the proposed clinical

studies protocol.

In Phase II, the sample size is increased to several hundred healthy volunteers,

and investigators focus on safety as well as immunogenicity. In Phase II(b)

“proof-of-concept” studies, dose-ranges and vaccine components are confirmed

28. Vaccine Development – 101, U.S. FDA, https://www.fda.gov/vaccines-blood-biologics/

development-approval-process-cber/vaccine-development-101 [https://perma.cc/HUD8-DBS9 ]

(Dec. 14, 2020).

29. See 42 U.S.C. § 262 (outlining the regulation of biological products).

30. See generally P

RINCIPLES OF BACTERIAL PATHOGENESIS (Eduardo A. Groisman ed., 2001).

31. Nicola P. Klein, Joan Bartlett, Ali Rowhani-Rahbar, Bruce Fireman & Roger Baxter, Waning

Protection After Fifth Dose of Acellular Pertussis Vaccine in Children, 367 N.

ENG. J. MED. 1012, 1013

(2012); Bo Ma, Li-Fang He, Yi-Li Zhang, Min Chen, Li-Li Wang, Hong-Wei Yang, Ting Yan,

Meng-Xiang Sun & Cong-Yi Zheng, Characteristics and Viral Propagation Properties of a New Human

Diploid Cell Line, Walvax-2, and Its Suitability as a Candidate Cell Substrate for Vaccine Production, 11

UM. VACCINES & IMMUNOTHERAUPETICS 998, 1004–05 (2015).

32. Rino Rappuoli, Reverse Vaccinology, a Genome-Based Approach to Vaccine Development, 19

VACCINE 2688, 2689 (2001).

33. Vaccine Development – 101, supra note 28.

34. 21 C.F.R. § 312.23 (2020).

35. Vaccine Development – 101, supra note 28.

36. U.S.

FDA, INVESTIGATIONAL NEW DRUG (IND) APPLICATION, https://www.fda.gov/

drugs/types-applications/investigational-new-drug-ind-application [ https://perma.cc/L9TJ-RQ6Y ]

(Feb. 24, 2021).

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 121

before moving to much larger Phase III studies.

Phase III vaccine trials enroll up

to thousands or tens of thousands of human subjects in order to detect rare adverse

events.

In 1998, for example, a rotavirus vaccine was licensed for use in the United

States after Phase III trials on approximately 10,000 infants showed safety and

efficacy. However, when administered to a larger population, physicians and

researchers observed an association between the vaccine and bowel obstruction,

resulting in the withdrawal of the vaccine.

If larger Phase III studies confirm safety

and efficacy, the vaccine is approved for marketing after the FDA’s review of

study data.

Safety evaluations are essential during each phase of the clinic trials and

continue after the approval of the vaccine. It is especially important to develop a

systematic approach to classifying side effects to be able to assess causality when a

side effect is observed in the clinical trial.

Until a vaccine is given to the general

population, not all potential adverse reactions can be anticipated.

Thus, many

vaccines undergo Phase IV: postmarketing surveillance and strict safety reporting

standards during and after clinical trials.

A key criterion during Phase IV studies is

to determine if there was a “reasonable possibility that the drug (or biologic) caused

[an adverse] event and whether the event (or pattern of events) [was] unexpected.”

Vaccine approval also requires adequate product labeling to allow health-care

providers to understand the vaccine’s proper use (including its potential benefits

and risks), to communicate with patients and parents, and to safely deliver the

vaccine to the public.

A product’s package insert, also known as the “label,” is a

critical element of the evaluation of a vaccination.

2. Tort Liability as a Regulatory Mechanism

Under the laws of most countries, regulatory review of medical products does

not generally preclude the liability for manufacturers of those products for injuries

37. See Bernd Schmidt, Proof of Principle Studies, 68 EPILEPSY RES. 49, 49 (2006).

38. Vaccine Development – 101, supra note 28.

39. Brian R. Murphy, David M. Morens, Lone Simonsen, Robert M. Chanock, John R. La

Montagne & Albert Z. Kapikian, Reappraisal of the Association of Intussusception with the Licensed Live

Rotavirus Vaccine Challenges Initial Conclusions, 187 J.

INFECTIOUS DISEASES 1301, 1301 (2003).

40. Vaccine Development – 101, supra note 28.

41. Jeffrey N. Roberts & Marion F. Gruber, Regulatory Considerations in the Clinical Development

of Vaccines Indicated for Use During Pregnancy, 33 V

ACCINE 966, 969 (2015); see Alberto E. Tozzi,

Edwin J. Asturias, Madhava Ram Balakrishnan, Neal A. Halsey, Barbara Law & Patrick L.F. Zuber,

Assessment of Causality of Individual Adverse Events Following Immunization (AEFI): A WHO Tool for

Global Use, 31 V

ACCINE 5041, 5041 (2013) (detailing a study commissioned to review the WHO’s

“Adverse Event Following Immunization (AEFI) causality assessment methodology and aid-memoire,

and to develop a standardized and user friendly tool to assist health care personnel in the process and

interpretation of data on induvial, and to assess the causality after AEFIs”).

42. See generally Tozzi et al., supra note 41; Vaccine Development – 101, supra note 28.

43. Vaccine Development – 101, supra note 28.

44. Roberts & Gruber, supra note 41, at 969.

45. Vaccine Development – 101, supra note 28.

46. 21 C.F.R. § 201.56–.57 (2020).

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122 UC IRVINE LAW REVIEW [Vol. 12:111

attributable to them. In EU member states, laws generally place liability for vaccine

side effects on pharmaceutical companies.

Over the course of the H1N1

pandemic, it was discovered that legal liabilities across the world, by default,

remained with manufacturers for the pandemic vaccine’s side effects, a matter that

resulted in significant delays as countries, the WHO, and manufacturers negotiated

over indemnity provisions.

Within the United States, vaccine side effects were (before 1986) generally

susceptible to state law claims made under principles of strict liability as well as tort

regimes specific to “unavoidably unsafe” products, which require only that

producers of medicines and vaccines properly prepare and market them and supply

sufficient warnings about their use.

The general idea for maintaining the possibility

of liability for side effects is that it supplies an incentive for manufacturers to

continually invest in the safety of their products and that, between an uninjured (and

presumptively compensated) manufacturer and an injured vaccine recipient, the law

should favor making the injured person whole.

After the adoption of the National

Childhood Vaccine Injury Act of 1986, vaccine side effects are now almost entirely

routed to a no-fault compensation system administered through the U.S. Court of

Federal Claims.

Worldwide, the law of product liability generally imposes three kinds of

obligations on vaccine manufacturers: to ensure that they manufacture vaccines

consistently with current good manufacturing practices (cGMPs); that they design

their vaccines so severe side effects are minimized to the greatest extent possible

without compromising their cost and utility; and that they properly label vaccines,

including the risks and benefits of administration.

In U.S. legal nomenclature,

these obligations are generally understood to give vaccine recipients the right to

receive vaccines free from manufacturing defects, design defects, and labeling

47. Francesco Guarascio, Limited Legal Protection for COVID Vaccine Makers Hampers EU

Deals, R

EUTERS (Aug. 26, 2020, 1:01 AM), https://www.reuters.com/article/us-health-coronavirus-

eu-vaccines/limited-legal-protection-for-covid-vaccine-makers-hampers-eu-deals-idUSKBN25M0RQ

[https://perma.cc/AE4Y-TDC3 ].

48. Sam F. Halabi, Obstacles to pH1N1 Vaccine Availability: The Complex Contracting

Relationship Between Vaccine Manufacturers, the World Health Organization, Donor and Beneficiary

Governments, in T

HE PUBLIC HEALTH RESPONSE TO 2009 H1N1: A SYSTEMS PERSPECTIVE 203, 207

(Michael A. Stoto & Melissa A. Higdon eds., 2015).

49. RESTATEMENT (SECOND) OF TORTS §§ 402, 402A cmt. k (AM. L. INST. 1965).

50. Bruesewitz v. Wyeth, 562 U.S. 223, 250 (2011) (Sotomayor, J. dissenting).

51. Vaccine Claims/Office of Special Masters, U.S.

CT. FED. CLAIMS, https://

www.uscfc.uscourts.gov/vaccine-programoffice-special-masters [https://perma.cc/KCN7-SA43 ]

(last visited Aug. 3, 2021 ).

52. Sam Halabi & John Monahan, Sharing the Burden of Ebola Vaccine-Related Adverse Events,

24 T

UL. J. INT’L & COMP. L. 131, 136 (2015); see also John C. Reitz, Doubts About Convergence: Political

Economy as an Impediment to Globalization, 12 TRANSNAT’L L. & CONTEMP. PROBS. 139, 140 (“Since

virtually all modern legal systems in the world are modeled to a substantial degree on aspects of either

the common or the civil law or both, especially with regard to their commercial law and some of their

public law, the convergence thesis seems relevant to all countries in the world.”); Bruesewitz, 562

U.S. at 250 (Sotomayor, J. dissenting).

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 123

defects (labeling defects include “failures to warn” of relevant risks, benefits, and

other relevant information).

This latter right enjoyed by vaccine recipients

overlaps to some degree, although not completely, with principles of

informed consent.

This Article focuses specifically on the possibility that legal action will be taken

because of a manufacturer’s actions, inactions, products, services, or other activities,

leading to claims based on: (1) product liability (including perception and attribution

of injury) and (2) informed consent/product labeling.

B. Product Liability and COVID-19 Vaccines

1. Real and Unknown Risks

Even safe and effective vaccines generate adverse events among those

inoculated, ranging from (common) soreness at the injection site, fever, discomfort,

and muscle pain to (rare) anaphylaxis and other severe reactions.

For vaccines

incorporating traditional platforms—like an inactivated virus (i.e., a killed virus,

commonly used for flu shots) or live-attenuated virus (i.e., a virus that has been

weakened under laboratory conditions, used for measles, mumps, and rubella

(MMR))—there are decades of evidence and well-controlled postimmunization

surveillance to confirm both safety and efficacy.

The occurrence of serious side

effects, such as those that result in death, threaten life, require inpatient

hospitalization, or result in significant disability, are rare (e.g., less than one adverse

event occurs per ten million doses for tetanus toxoid vaccines, one to two adverse

events per one million doses for inactivated influenza vaccine, and none for

hepatitis A).

a. New Vaccine Technologies

Robust data sets are essential to better define risk to specific subgroups,

clearly demonstrate clinical benefit, better define and continue to evaluate as part

of an ongoing process the safety profile of the vaccine, and facilitate

53. W. PAGE KEETON, DAN B. DOBBS, ROBERT E. KEETON & DAVID G. OWEN, PROSSER

AND

KEETON ON THE LAW OF TORTS § 99, at 695 (5th ed. 1984) (student ed.).

54. Sheldon F. Kurtz, The Law of Informed Consent: From “Doctor is Right” to “Patient Has

Rights”, 50 SYRACUSE L. REV. 1243, 1245 (2001) (“Today, the right of a patient to participate to some

extent in medical decision making affecting the patient is universally dictated by the ‘informed consent’

laws of all states.”).

55. Luana Raposo de Melo Moraes Aps, Marco Aurélio Floriano Piantola, Sara Araujo Pereira,

Julia Tavares de Castro, Fernanda Ayane de Oliveira Santos & Luís Carlos de Souza Ferreira, Adverse

Events of Vaccines and the Consequences of Non-Vaccination: A Critical Review, 52 R

EVISTA DE SAÚDE

PÚBLICA 1, 3 (2018) (“The administration of these compounds may lead to adverse reactions, such as

local inflammatory reactions and, much less frequently, systemic effects, such as the exacerbation of

autoimmune diseases and allergies.”).

56. See generally Stanley Plotkin, History of Vaccination, 111 PNAS 12283 (2014).

57. Halabi & Omer, supra note 26, at 471.

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124 UC IRVINE LAW REVIEW [Vol. 12:111

communication of benefit/risk data and information that will mitigate litigation

risk.

The safety profile of vaccination with newer platforms like DNA,

non-replicating viral vector, protein subunit, and RNA vaccines, including

adjuvants,

is less extensive than with platforms with long safety profiles like

inactivated or live-attenuated vaccines.

The use of DNA vaccines, for example,

has raised safety concerns mainly regarding the probability of stable integration of

transfected DNA into the genome of somatic or even germ cells, causing

dysregulated gene expression and mutations.

Most COVID-19 vaccine candidates, and certainly the leading ones, are

generally based on these new kinds of technologies, which are not licensed for use

in humans anywhere in the world.

AstraZeneca’s candidate, ChAdOx1 nCoV-19,

for example, uses a chimpanzee adenovirus (the same that causes the common cold)

to deliver a SARS-CoV-2 spike protein, which then prompts an immune response

to that protein when exposure to the actual SARS-CoV-2 pathogen occurs.

Moderna’s and Pfizer’s vaccine candidates are based on messengerRNA (generally

58. Michael M. McNeil, Julianne Gee, Eric S. Weintraub, Edward A. Belongia, Grace M. Lee,

Jason M. Glanz, James D. Nordin, Nicola P. Klein, Roger Baxter, Allison L. Naleway, Lisa A. Jackson,

Saad B. Omer, Steven J. Jacobsen & Frank DeStefano, The Vaccine Safety Datalink: Successes and

Challenges Monitoring Vaccine Safety, 32 V

ACCINE 5390, 5393 (2014) (“Recognizing the need for a

flexible, timely and robust system to evaluate vaccine safety and supplement information provided by

VAERS, CDC established the Vaccine Safety Datalink (VSD) in 1990 to conduct post-marketing

vaccine safety evaluations in defined populations.”).

59. Takehiro Ura, Kenji Okuda & Masaru Shimada, Developments in Viral Vector-Based

Vaccines, 2 V

ACCINES 624, 632 (2014) (“Viral vector-based vaccines can be easily manufactured

alongside traditional vaccines in large manufacturing units, and their safety profiles can be

tested easily.”).

60. Claudia Maria Trombetta, Elena Gianchecchi & Emanuele Montomoli, Influenza

Vaccines: Evaluation of the Safety Profile, 14 H

UM. VACCINES & IMMUNOTHERAPEUTICS, 657, 658

(2018) (“Inactivated vaccines have an excellent safety profile.”).

61. Jacob Glenting & Stephen Wessels, Ensuring Safety of DNA Vaccines, M

ICROBIAL CELL

FACTORIES (Sept. 6, 2005), https://microbialcellfactories.biomedcentral.com/track/pdf/10.1186/

1475-2859-4-26.pdf [ https://perma.cc/CE26-63GN ] (“[I]nternational regulatory groups have recently

questioned the safety of certain existing DNA vaccine constructs.”).

62. Asher Mullard, COVID-19 Vaccine Development Pipeline Gears Up, 395 LANCET 1751,

1751 (2020).

63. Pedro M. Folegatti, Katie J. Ewer, Parvinder K. Aley, Brian Angus, Stephen Becker, Sandra

Belij-Rammerstorfer, Duncan Bellamy, Sagida Bibi, Mustapha Bittaye, Elizabeth A. Clutterbuck,

Christina Dold, Saul N. Faust, Adam Finn, Amy L. Flaxman, Bassam Hallis, Paul Heath, Daniel Jenkin,

Rajeka Lazarus, Rebecca Makinson, Angela M. Minassian, Katina M. Pollock, Maheshi Ramasamy,

Hannah Robinson, Matthew Snape, Richard Tarrant, Merryn Voysey, Catherine Green, Alexander

D. Douglas, Adrian V.S. Hill, Teresa Lambe, Sarah C. Gilbert & Andrew J. Pollard, Safety and

Immunogenicity of the ChAdOx1 nCoV-19 Vaccine Against SARS-CoV-2: A Preliminary Report of a

Phase 1/2, Single-Blind, Randomised Controlled Trial, 396 L

ANCET 467, 468, (2020); Allison Martell

& Julie Steenhuysen, Explainer: How Common Cold Viruses are Being Used in Vaccines from Russia,

China, R

EUTERS (Aug. 31, 2020, 3:09 AM), https://www.reuters.com/article/us-health-coronavirus-

vaccines-adenoviru/how-common-cold-viruses-are-being-used-in-vaccines-from-russia-china-idUSK

BN25R192 [ https://perma.cc/W2QZ-NSJ7 ].

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 125

known as mRNA) that instruct human cells to produce protein antigens.

The idea

is that once a person receives those RNA instructions in an injected vaccine, their

cells express proteins. These are then displayed on cell surfaces or released into the

circulation, where the body’s natural immune system recognizes them.

The

regulatory review process generally vets vaccine candidates, not vaccine platforms;

thus, there is no additional scrutiny given to new technologies that raise risks of

causing dysregulated gene expression and/or mutations.

b. Side Effects Following Phase III and EUA COVID-19 Vaccines

Incidents from Phase III trials have given a reasonable basis to prepare for

severe side effects not only because the technologies are new but because the scale

of mass vaccination is unprecedented. AstraZeneca’s Phase III trial was paused

worldwide after two volunteers experienced inflammation of the spinal cord.

Johnson & Johnson’s vaccine trial was also paused during Phase III for rare blood-

clotting events.

Two people in the U.K. had severe reactions to Pfizer’s vaccine

within the first week.

In the United States, there have been twenty-one cases of

anaphylaxis and at least one suspected case linking vaccine administration to

severe bleeding.

After significant doses were administered, safety signals were recorded for all

leading vaccines: AstraZeneca’s (marketed as Vaxzevria in the EU), Johnson

& Johnson’s, and Pfizer-BioNTech’s. In March 2021, with more than twenty-five

million people receiving the Vaxzevria vaccine, more than twenty countries stopped

vaccinations after reports of young patients suffering severe clotting disorders and

rare types of strokes.

The European Medicines Agency (EMA) safety committee

64. Amber Dance, Coronavirus Vaccines Get a Biotech Boost, NATURE ( July 21, 2020), https://

www.nature.com/articles/d41586-020-02154-2 [https://perma.cc/W96K-U5B2 ].

65. Id.

66. J

OHNS HOPKINS, VACCINE PLATFORMS: STATE OF THE FIELD AND LOOMING

CHALLENGES 5 (2019) (noting that “regulatory agencies approve products, not platforms”).

67. Rachel Arthur, AstraZeneca Resumes US COVID-19 Vaccine Trial; Expects Results Later

this Year, BIOPHARMA-REP. (Nov. 5, 2020, 10:00 AM), https://www.biopharma-reporter.com/

Article/2020/10/26/AstraZeneca-resumes-US-COVID-19-vaccine-trial [https://perma.cc/JX53-9LMK].

68. Rachel Arthur, Johnson & Johnson Pauses COVID-19 Vaccine Trial Due to an Unexplained

Illness, B

IOPHARMA-REP. (Oct. 13, 2020, 10:58 AM), https://www.biopharma-reporter.com/Article/

2020/10/13/Johnson-Johnson-pauses-COVID-19-vaccine-trial-due-to-an-unexplained-illness [https://

perma.cc/VH5X-BJJN ]; https://www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-

recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough

69. Sugden, supra note 16.

70. Amy Goldstein, Laurie McGinley, Isaac Stanley-Becker & Fenit Nirappil, Biden Plans to

Release Nearly All Available Vaccine Doses to Speed Inoculations, W

ASH. POST ( Jan 8. 2021, 8:40 PM)

https://www.washingtonpost.com/health/biden-plans-to-release-of-nearly-all-available-vaccine-doses

-to-speed-inoculations/2021/01/08/93d58c72-51db-11eb-83e3-322644d82356_story.html [https://

perma.cc/FYZ2-Q55X ].

71. Kai Kupferschmidt & Gretchen Vogel, European Countries Resume Use of AstraZeneca’s

COVID-19 Vaccine, Hoping Pause has Not Dented Confidence, S

CIENCE (Mar. 18, 2021), https://

www.sciencemag.org/news/2021/03/european-countries-resume-use-astrazenecas-covid-19-vaccine-

hoping-pause-has-not-dented [ https://perma.cc/B4YN-X8RW ].

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126 UC IRVINE LAW REVIEW [Vol. 12:111

did an in-depth review of sixty-two cases of cerebral venous sinus thrombosis and

twenty-four cases of splanchnic vein thrombosis, eighteen of which were fatal, that

had been reported in the EU drug safety database as of March 18, 2021.

On April

7, 2021, the EMA concluded that unusual blood clots with low blood platelets

should be listed as a very rare side effect of Vaxzevria.

Several countries updated

their recommendation on the use of Vaxzevria, with fifteen countries adopting

specific recommendations to administer Vaxzevria only to certain age groups and

twelve countries recommending use of Vaxzevria based on EMA guidelines with

exceptions for those with a history or risk of thromboembolism and pregnant

women.

Two countries discontinued the use of Vaxzervia.

In the United States, the Johnson & Johnson vaccine was paused after reports

of six cases of a rare and severe type of blood clot in individuals following

administration of the vaccine.

The FDA and CDC scientific teams examined

available data of the 6.8 million doses that had been administered to assess the risk

of thrombosis.

The EMA agency has concluded a review of the Pfizer-BioNTech vaccine that

has reports of facial swelling for people who have received dermal fillers and is

continuing to follow reports of heart muscle inflammation after receipt of the

Pfizer-BioNtech vaccine.

c. H1N1

Assuming a severe side effect rate of 2.45 per 100,000—a measure based on

the U.S. experience with pandemic H1N1 vaccine—and certainly at 11.1 cases per

million, the scale of adverse events would be significant.

The WHO estimates the

delivery of two billion vaccine doses that will necessarily involve deployment of

adenovirus (AstraZeneca and Johnson & Johnson) and messenger RNA (Moderna

72. Press Release, Eur. Meds. Agency, AstraZeneca’s COVID-19 Vaccine: EMA Finds Possible

Link to Very Rare Cases of Unusual Blood Clots with Low Platelets (July 4, 2021), https://

www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases

-unusual-blood-clots-low-blood [ https://perma.cc/Z75E-VJQM ].

73. Id.

74.

EUR. CTR. FOR DISEASE PREVENTION & CONTROL, supra note 18, at 1.

75. Id.

76. Press Release, U.S. FDA, FDA and CDC Lift Recommended Pause on Johnson & Johnson

( Janssen) COVID-19 Vaccine Use Following Thorough Safety Review (Apr. 23, 2021), https://

www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnson-

johnson-janssen-covid-19-vaccine-use-following-thorough [https://perma.cc/ZUK3-DY3C].

77. Id.

78. Kari Oakes, PRAC Investigates Heart Inflammation Reports with Pfizer Vaccine,

EGUL. AFFS. PROS. SOC’Y (May 7, 2021), https://www.raps.org/news-and-articles/news-articles/

2021/5/prac-investigates-heart-inflammation-reports-with [http://web.archive.org/web/2021050721

5317/https://www.raps.org/news-and-articles/news-articles/2021/5/prac-investigates-heart-inflam

mation-reports-with].

79. Bardenheier et al., supra note 21, at 4408.

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 127

and Pfizer) vaccines as well as some based on conventional technologies.

The

same rate of severe side effects—those suffering disability or death or with illnesses

requiring hospitalization—would reach 50,000 to 200,000 worldwide. That number

may underestimate the prevalence and severity of side effects following COVID-19

immunizations. Over the course of the H1N1 pandemic, an adjuvanted vaccine

distributed by GlaxoSmithKline (GSK) was associated with a heightened risk of

narcolepsy, a condition associated with people of Northern European descent.

Adjuvanted H1N1 vaccines were not licensed in the United States.

In the 2009 H1N1 pandemic, the negotiations over indemnification and

immunity for manufacturers caused significant delays.

When the 2009 H1N1 virus

began emerging as a potential pandemic, pharmaceutical firms began negotiating

with the WHO over conditions for the global distribution of a vaccine, which is the

most important defense against a pandemic.

From the manufacturers’ perspective, these negotiations occurred in the

shadow of potentially large liabilities related to their existing contractual

arrangements with governments, detailed processes for vaccine approval,

distribution and marketing, as well as more general exposure should

quickly-developed vaccines generate unexpected adverse reactions or

safety problems. . . . In many jurisdictions, manufacturers bear legal

responsibility for these adverse events, although many states change these

liabilities in cases of public health emergencies. Nevertheless,

manufacturers faced a range of legal barriers to production, donation and

discounted sale of pandemic vaccines . . . .

The negotiations had two sources of delay: first, both manufacturers and

countries had entered into agreements regarding purchasing vaccines, which

severely curtailed manufacturers’ ability to donate vaccines as large numbers of their

production were promised to wealthy states that had paid for them; second, the

80. Helen Branswell, WHO, Partners Unveil Ambitious Plan to Deliver 2 Billion Doses of

Covid-19 Vaccine to High-risk Populations, STAT ( June 26, 2020), https://www.statnews.com/2020/

06/26/who-partners-unveil-ambitious-plan-to-deliver-2-billion-doses-of-covid-19-vaccine-to-high-

risk-populations/ [https://perma.cc/7EZJ-PA5A ].

81. D

IV. OF HEALTH PROMOTION & DISEASE PREVENTION, INST. OF MED., VACCINE

SUPPLY AND INNOVATION 85 (1985) (“A manufacturer who produces and sells a defective vaccine

that creates a risk of significant injury to the recipient is liable to any person injured by that defect.”);

Narcolepsy Following 2009 Pandemrix Influenza Vaccination in Europe,

CTRS. FOR DISEASE CONTROL

& PREVENTION, https://www.cdc.gov/vaccinesafety/concerns/history/narcolepsy-flu.html

[https://perma.cc/HG6C-2SQC ] (last visited Aug. 20, 2020 ).

82. I

NST. OF MED., THE DOMESTIC AND INTERNATIONAL IMPACTS OF THE 2009-H1N1

INFLUENZA A PANDEMIC: GLOBAL CHALLENGES, GLOBAL SOLUTIONS: WORKSHOP SUMMARY 12

(2010) (“Progress toward mass immunization was temporarily stalled when the vaccine manufacturers

demanded indemnification against claims of any adverse reactions associated with the vaccines.”).

83. Sam F. Halabi, Obstacles to pH1N1 Vaccine Availability: the Complex Contracting Relationship

between Vaccine Manufacturers, WHO, Donor and Beneficiary Governments in MA Stoto and M Higdon (eds.),

HE PUBLIC HEALTH RESPONSE TO H1N1: A SYSTEMS PERSPECTIVE 203-16 (Oxford University

Press, 2015).

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128 UC IRVINE LAW REVIEW [Vol. 12:111

vaccine manufacturers insisted on legal protections in countries where they were

not licensed to produce or distribute a vaccine.

The U.S. experience with the 1976 H1N1 outbreak demonstrates some of

these risks.

The influenza pandemic of 1918 killed an estimated fifty million

people, so governments around the world and the WHO have invested steeply in

preparation for influenza.

In 1976, a handful of soldiers in Fort Dix, New Jersey,

were diagnosed with the virus.

The CDC hosted a press conference and, although

the virus never spread out of the base, the outbreak garnered significant media

attention.

President Ford initiated a program to vaccinate “every man, woman,

and child in the United States.”

Vaccine manufacturers began developing a

vaccine, but during clinical testing, three subjects died of complications for reasons

unrelated to the vaccine.

This generated negative sentiment toward the vaccine.

Then, over 400 people developed a rare neurological condition after receiving the

vaccine, which resulted in the termination of the vaccine program.

The U.S. government and pharmaceutical manufacturers agreed in advance to

an indemnification of risk for the manufacturer, which resulted in the

U.S. government being the defendant in the suits arising from the vaccine

complications. Ultimately, the United States was named as defendant in over 1,000

lawsuits and paid approximately $83 million in claims.

For comparison, the

vaccination program as a whole was estimated to cost $134 million, with $100

million for the development of the vaccine.

84. Id.; WHO Director-General, Report of the Review Committee on the Functioning of the

International Health Regulations (2005) in Relation to Pandemic (H1N1) 2009, WHO Doc. A64/10

(May 5, 2011) (“Among the key difficulties was a variation in willingness to donate, concerns about

liability, complex negotiations over legal agreements, lack of procedures to bypass national regulatory

requirements and limited national and local capacities to transport, store and administer vaccines.”).

85. Rebecca Kreston, The Public Health Legacy of the 1976 Swine Flu Outbreak, D

ISCOVER

MAG. (Sept. 30, 2013, 1:30 PM), https://www.discovermagazine.com/health/the-public-health-

legacy-of-the-1976-swine-flu-outbreak [ https://perma.cc/85W6-YZPR ].

86. Brooke Killian Kim & Jessica C. Wilson, COVID-19: Tort Immunity for Vaccines and

Antivirals — Lessons from the Swine Flu of 1976, DLA

PIPER (April 8, 2020), https://

www.dlapiper.com/en/us/insights/publications/2020/04/covid-19--tort-immunity-for-vaccines-and-

antivirals/[ https://perma.cc/M4S5-GLWV ]; see generally H.R. D

OC. NO 77-115 (1977).

87. Kim et al., supra note 86.

88. President Gerald R. Ford, Remarks Announcing the National Swine Flu Immunization

Program in the White House Briefing Room (March 24, 1976) (transcript available in the Gerald

R. Ford Presidential Library & Museum); H.R. D

OC. NO 77-115 (1977); RICHARD E. NEUSTADT

HARVEY V. FINEBERG, THE SWINE FLU AFFAIR: DECISION-MAKING ON A SLIPPERY DISEASE 4,

6–7 (1978).

89. President Gerald R. Ford, supra note 88.

90. Kim et al., supra note 86.

91. Id.

92. Id.

93. Id.

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 129

d. Dengue

The dengue virus, transmitted by the aedes aegypti mosquito in tropical regions

of the world, causes a range of symptoms, from subclinical, when people might not

know they are infected, to symptoms similar to that of a severe influenza disease,

which causes “bleeding, organ impairment, and/or plasma leakage.”

The WHO

estimates that there are 390 million dengue infections per year; of those, 96 million

present with some severity of the virus and around 20,000 cases result in

death—usually among children.

Dengue is present in 129 countries, and over the

last fifty years, it is believed that dengue has increased at least thirtyfold with a sharp

increase after 2000.

Since that point, it has been labeled a priority pathogen for the

development of a licensed vaccine, but as with many diseases affecting poorer

countries (seventy percent of cases occur in low-income countries in Asia), the

actual market incentive for doing so is limited.

After nearly twenty years of research and development, Sanofi Pasteur finally

produced the CYD-TDV vaccine, licensed under the name Dengvaxia, the first and

only approved vaccine to inoculate against dengue infection.

To date, Dengvaxia

has been registered in twenty

countries including the EU member states and the

United States.

100

There have been two subnational

101

immunization implementation

94. Dengue and Severe Dengue, WORLD HEALTH ORG. ( June 23, 2020), https://www.who.int/

news-room/fact-sheets/detail/dengue-and-severe-dengue [https://perma.cc/X4J6-T6U2 ].

95. Dengue Vaccine: WHO Position Paper –September 2018, 36

WKLY. EPIDEMIOLOGICAL

REC. OF THE WORLD HEALTH ORG. [WHO] 457, 458 (2018) [hereinafter Dengue Vaccine: WHO

Paper], https://apps.who.int/iris/bitstream/handle/10665/274315/WER9336.pdf?ua=1 [ https://

perma.cc/Q4WF-NV42 ]; Sarah Murrell, Suh-Chin Wu & Michael Butler, Review of Dengue Virus and

the Development of a Vaccine, 29

BIOTECHNOLOGY ADVANCES 239, 240 (2011).

96. See Murrell et al., supra note 95, at 240 (noting the belief that Dengue “DENV” is under

reported because it can present asymptomatic or misreported because symptoms are similar to other

viruses, additionally, the uptake after 2000 is believed to be sparked by “geographic expansion of the

vector”); Dengue and Severe Dengue, supra note 94.

97. See C

TR. FOR GLOB. DEV. & GLOB. HEALTH POL’Y RSCH. NETWORK, MAKING MARKETS

FOR

VACCINES: A PRACTICAL PLAN, 1, 24 https://www.who.int/intellectualproperty/news/en/

SubmissionBarder1.pdf [https://perma.cc/VV9G-THE5] (last visited Jan. 14, 2021) (Consultation

Draft); Dengue Vaccine: WHO Paper, supra note 95, at 476.

98. However, there are two vaccine candidates in Phase III trials at this time. Dengue

Vaccine: WHO Paper, supra note 95, at 463.

99. Some of the countries include: Mexico, the Philippines, Brazil, El Salvador, Costa Rica,

Paraguay, Guatemala, Peru, Indonesia, Thailand, and Singapore. Sanofi’s Dengue Vaccine Approved in

11 Countries, R

EUTERS (Oct. 3, 2016, 10:55 PM), https://www.reuters.com/article/us-sanofi-

vacccine-idUSKCN1240C5 [ https://perma.cc/3TN5-V9T7 ].

100. Dengvaxia has been approved by the FDA in the U.S. only for nine-to-sixteen-year-old

children in Puerto Rico, the U.S. Virgin Islands, American Samoa, and Guam. Angus Liu, After Safety

Mess, Sanofi’s Dengue Shot Nabs a Sharply Limited FDA Nod, F

IERCE PHARMA (May 2, 2019, 10:55

AM), https://www.fiercepharma.com/vaccines/sanofi-nabs-fda-nod-for-dengvaxia-despite-philippines

-mess-but-a-much-smaller-population [ https://perma.cc/U5CZ-FB4U]; Stephen J. Thomas & In-Kyu

Yoon, A Review of Dengvaxia®: Development to Deployment, 15 H

UM. VACCINES

& IMMUNOTHERAPEUTICS 2295, 2295 (2019).

101. In a three-tiered governmental system—national, regional, and local

government—subnational refers to regional and local government. Katja Rohrer, Chapter

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130 UC IRVINE LAW REVIEW [Vol. 12:111

public health programs in Brazil and the Philippines.

102

The vaccine was studied

over twenty-six clinical trials that included more than 41,000 volunteers.

103

The

clinical trial participants were monitored for up to five years after the trial.

104

Despite the large trial enrollment and postimmunization monitoring, it

happens that for children under nine and for a subset of children who had never

before been exposed to the virus, the vaccine increases the chance of severe disease,

an occurrence that resulted in significant liabilities in the Philippines.

105

On average,

200,000 cases of dengue infection are reported every year in the Philippines.

106

The

aggregate direct medical cost for these infections in the country is estimated to be

over $345 million per year and causes children to lose on average 5.6 days of school

and adults to lose 9.9 days of work per episode.

107

Dengvaxia was licensed in the

Philippines in 2016.

108

After licensure, a subnational Dengvaxia immunization

program costing $67.7 million

109

was developed with the goal of vaccinating one

million Filipino children.

110

The Philippines vaccinated 830,000 children ages nine

to ten living in highly endemic regions

111

before it was realized or acknowledged

that there was an enhanced risk for severe illness for children who were

seronegative—without antibodies to the virus.

112

Sanofi Pasteur reported the safety

issues in 2017, and the program was promptly ended.

113

In 2019, the Philippines

11: Strategizing for Health at Sub-national Level, in STRATEGIZING NATIONAL HEALTH IN THE 21ST

CENTURY: A HANDBOOK 1, 1 (Gerard Schmets, Dheepa Rajan & Sowmya Kadandale eds., 2016),

https://apps.who.int/iris/bitstream/handle/10665/250221/9789241549745-chapter11-eng.pdf?sequence

=35&isAllowed=y [https://perma.cc/B29Z-2U3K ].

102. Thomas & Yoon, supra note 100, at 2303, 2308.

103. Id. at 2297.

104. Stefan Flasche, Annelies Wilder-Smith, Joachim Hombach & Peter G. Smith, Estimating

the Proportion of Vaccine-Induced Hospitalized Dengue Cases Among Dengvaxia Vaccines in the

Philippines, W

ELLCOME OPEN RSCH. (Oct. 31, 2019), https://wellcomeopenresearch.org/articles/4-

165/v1 [https://perma.cc/5CA2-MHZJ ] (version 1; peer review: 2 approved).

105. Thomas & Yoon, supra note 100, at 2303, 2308.

106. Mong Palatino, The Health of Thousands of Filipino Children Could Be at Risk, Thanks to

Sanofi’s Dengue Vaccine, G

LOB. VOICES (Dec. 7, 2017, 5:35 GMT), https://globalvoices.org/2017/

12/07/the-health-of-thousands-of-filipino-children-could-be-at-risk-thanks-to-sanofis-dengue-vaccine/

[https://perma.cc/25ZB-GVAG].

107. $365 million per year is measured in 2012 USD. Ronald U. Mendoza, Sheena A. Valenzuela

& Manuel M. Dayrit, A Crisis of Confidence: The Case of Dengvaxia in the Philippines 1,

5 (Ateneo

Sch. of Gov’t., Working Paper No. 20-002, 2020).

108. Flasche et al., supra note 104, at 3.

109. Karen Lema & Matthias Balmont, Philippines to Charge Officials of Sanofi, Government Over

Dengue Vaccine, R

EUTERS (Mar. 1, 2019, 12:51 AM), https://www.reuters.com/article/us-sanofi-fr-

philippines/philippines-to-charge-officials-of-sanofi-government-over-dengue-vaccine-idUSKCN1QI41L

[https://perma.cc/959H-D2VY ].

110. Flasche et al., supra note 104, at 3.

111. “The dengue seroprevalance in this population is not known, but has been estimated to be

between 80 and 85%, extrapolating from data from the trial sites in the Philippines included in the

Phase 3 trial.” Id. at 3.

112. Id. at 1.

113. Id. at 3.

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 131

permanently banned Dengvaxia.

114

Alleged delays by Sanofi in disclosing safety

signals following Dengvaxia campaigns have resulted in criminal indictments against

Sanofi executives, demands for repayment of the price of the Dengvaxia doses, and

additional liabilities related to ten deaths attributed to Dengvaxia administration.

115

For these and other reasons, governments and global leaders must plan for

liability and compensation as a component of the broader international response to

COVID-19.

116

In countries with strict liability regimes for vaccines, there is a limited

obligation for a plaintiff to prove causation between the vaccination and the injury,

only that the immunization and the injury are related in place and time.

117

Even if a

manufacturer took due care, that is, manufactured the vaccine non-negligently,

vaccines will cause these rare severe injuries.

118

In most countries, a plaintiff (whether individual or governmental) is under an

obligation to prove causation between an injury and the vaccine that preceded it.

119

The method by which causation is established under product liability law differs in

key respects from the accepted method of establishing causation in science

and epidemiology.

120

114. Carol Isoux, Are Philippine Children’s Deaths Linked to Dengue Vaccine?, POST

MAG. (April 21, 2019, 2:30 AM), https://www.scmp.com/magazines/post-magazine/long-reads/

article/3006712/philippines-suspicion-dengue-vaccine-linked [ https://perma.cc/DUY9-X85F ].

115. Vince F. Nonato, Solon: Sanofi Will Be Held Liable for ‘Misrepresenting’ Dengvaxia Safety,

HIL. DAILY INQUIRER (Dec. 10, 2017, 6:30 PM), http://newsinfo.inquirer.net/951181/solon-sanofi-

will-be-held-liable-for-misrepresenting-dengvaxia-safety [https://perma.cc/SHC4-B7XD ] (“The

House of Representatives Committee on Good Government and Public Accountability will hold Sanofi

Pasteur liable for allegedly misrepresenting the side effects of Dengvaxia, as the French pharmaceutical

giant only recently disclosed the risks months after the congressional inquiry had ended.”). The

indictments are a good example of using respondeat superior theories when the Philippines Department

of Justice is pursuing criminal allegations against Sanofi for omissions that are in fact attributable to the

corporations, not its president or other indicted officers. See generally Mihailis E. Diamantis, Corporate

Criminal Minds, 91 NOTRE DAME L. Rev. 2049 (2016).

116. DIV. OF HEALTH PROMOTION & DISEASE PREVENTION, INST. OF MED., supra note 81,

at 28 (“Testimony [in response to the expected DTP vaccine shortage due to unstable supplies]

. . . from Squibb-Connaught indicated that [the vaccine distributors of DTP in 1984] had continued

manufacturing vaccine and would be willing to distribute it if some federal protection were provided

from [the high] liability risks.”).

117. Clare Looker & Heath Kelly, No-fault Compensation Following Adverse Events Attributed

to Vaccination: A Review of International Programmes, 89 B

ULLETIN OF THE WORLD HEALTH

ORGANIZATION [WHO] 371, 375 (2011), https://apps.who.int/iris/bitstream/handle/10665/

270902/PMC3089384.pdf?sequence=1&isAllowed=y [ https://perma.cc/B7Z4-6P3V ] (“This process

presumes causation if any injury listed in the table occurs within a specified time frame after

vaccination. . . . [P]rogrammes are based on the premise that the adverse outcome is not attributable to

a specific individual or industry but due to an unavoidable risk associated with vaccines.”).

118. See id. at 371.

119. See, e.g., C

OMM. ON THE CHILD.’S VACCINE INITIATIVE, INST. OF MED., THE

CHILDREN’S VACCINE INITIATIVE: ACHIEVING THE VISION 163 (Violaine S. Mitchell, Nalini

M. Philipose & Jay P. Sanford eds., 1993) (“If the conditions of the petitioner are not included in the

table, they must then prove causation by a covered vaccine.”).

120. D

IV. OF HEALTH PROMOTION & DISEASE PREVENTION, INST. OF MED., supra note 81,

at 85–86, 155 (“The difficulty of proving or disproving a causal relationship between a given vaccine

and a particular injury suggests that if causation is required, for payment of compensation, outcomes

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132 UC IRVINE LAW REVIEW [Vol. 12:111

2. Perceived and Falsely Attributed Risks

Not only will real and unknown risks shape legal liabilities but perceived

associations will shape them as well.

121

In many countries, propaganda campaigns

inducing fears of sterility or of contracting HIV from vaccination inhibit use as well

as fuel suspicions that manufacturers from wealthy countries use people in

developing countries as human “guinea pigs.”

122

For example, in 2013, a subset of

religious leaders in Kenya initiated an antivaccine campaign based in part on these

kinds of accusations.

123

Demonstration projects with the HPV vaccine, aimed at

preventing the cause of cervical cancer in virtually all cases, in the Indian states of

Andhra Pradesh and Gujarat resulted in the preliminary (and erroneous) association

of the vaccine with seven deaths, resulting in the suspension of those vaccination

efforts, the discovery of defects in informed consent communications, and a

significant delay of expanded HPV coverage.

124

Reports of adverse events

prompted litigation at the Supreme Court of India as well as a ministerial review of

the informed consent protocols used by researchers.

125

While no panel convened

by the Supreme Court, the legislature, or the Ministry of Health and Welfare found

any evidence that the vaccines caused any injuries, those entities found defects in

informed consent procedures, and although not technically parties, GSK and Merck

were required to respond to official inquiries.

126

Because causation will be a key aspect of any action to recover money

damages, litigation risk is far more significant for perceived injuries or false

attribution of background events to a vaccination.

127

Many countries suffer from

will depend on who is required to carry the burden of proof. . . . [T]hese efforts to prove causation will

be time-consuming, expensive, and probably inconclusive.”).

121. Eve Dubé, Caroline Laberge, Maryse Guay, Paul Bramadat, Réal Roy & Julie Bettinger,

Vaccine Hesitancy: An Overview, 9 H

UM. VACCINES & IMMUNOTHERAPEUTICS 1763, 1769 (“[R]isk

perceptions are predictors of adult vaccination behavior.”).

122. See Tara C. Smith, Vaccine Rejection and Hesitancy: A Review and Call to Action, OPEN

INFECTIOUS DISEASES, Summer 2017, at 1, 1 (“[M]ultiple studies have demonstrated concerning

patterns of decline of confidence in vaccines.”).

123. Jill Olivier, Interventions with Local Faith Communities on Immunization in Development

Contexts, R

EV. FAITH & INT’L AFFS., Fall 2016, at 36, 36 (“Kenyan Catholic Bishops called for a boycott

of the . . . vaccine . . ., arguing that the vaccine was dangerous.”).

124. R. Prasad, Opinion, A Second Chance for the HPV Vaccine, HINDU (Oct. 8, 2017, 3:33

PM), http://www.thehindu.com/todays-paper/tp-opinion/a-second-chance-for-the-hpv-vaccine/

article19821936.ece [https://perma.cc/GR3W-EUAX ]; Sanjay Kumar & Declan Butler, Calls in India

for Legal Action Against US Charity, N

ATURE (Sept. 9, 2013), https://www.nature.com/news/calls-

in-india-for-legal-action-against-us-charity-1.13700 [https://perma.cc/NJB7-6AT8].

125. Kumar & Butler, supra note 124; Carolijn Terwindt, Health Rights Litigation Pushes for

Accountability in Clinical Trials in India, H

EALTH & HUM. RTS. J., Dec. 2014, at 84, 87–88, https://

cdn1.sph.harvard.edu/wp-content/uploads/sites/2469/2014/12/Terwindt-final1.pdf [https://

perma.cc/G5XT-TVXL ].

126. Terwindt, supra note 125, at 88.

127. See Richard Kent Zimmerman, James J. Schlesselman, Tammy A. Mieczkowski, Anne

R. Medsger & Mahlon Raymund, Physician Concerns About Vaccine Adverse Effects and Potential

Litigation, 152 A

RCHIVES PEDIATRICS & ADOLESCENT MED. 12, 12 (1998) (“Physicians’ perceptions

about the risk for adverse effects and protection afforded by the Vaccine Injury Compensation Program

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 133

high background levels of morbidity and mortality, and coincidental deaths

associated with vaccine administration attributed to the vaccine may give rise to

litigation, even if rigorous analysis of objective data ultimately vindicates the

manufacturer and its product.

128

It is well established that there is widespread

misunderstanding in developing countries about what respiratory illnesses are, how

they are transmitted, and what their effects might be.

129

Background skepticism of

vaccine campaigns may increase the chance that specific events or injuries are

attributed to COVID-19 vaccines.

130

Moreover, COVID-19 vaccines are unlikely to

be as efficacious as the most efficacious vaccines, like the measles vaccine,

increasing the chance that someone who received an immunization and becomes ill

may conflate the two.

131

influence their concern about litigation and, to a lesser extent, their reported likelihood to

administer immunizations.”).

128. Elaine R. Miller, Pedro L. Moro, Maria Cano & Tom Shimabukuro, Deaths Following

Vaccination: What Does the Evidence Show?, 33 V

ACCINE 3288, 3288 (2015).

129. Prisca Adhiambo Oria, Geoffrey Arunga, Emmaculate Lebo, Joshua M. Wong, Gideon

Emukule, Philip Muthoka, Nancy Otieno, David Mutonga, Robert F. Breiman & Mark A. Katz,

Assessing Parents’ Knowledge and Attitudes Towards Seasonal Influenza Vaccination of Children Before

and After a Seasonal Influenza Vaccination Effectiveness Study in Low-income Urban and Rural Kenya,

2010–2011, 13 BMC

PUB. HEALTH 391, 395 (2013), https://bmcpublichealth.biomedcentral.com/

track/pdf/10.1186/1471-2458-13-391.pdf [https://perma.cc/5UTV-7XJW ] (“Of the 36

pre-vaccination focus group discussion participants, a majority said the main causes of influenza were

low temperatures and dust. A few also said smoke, contact with influenza-infected persons and allergic

reactions could cause influenza.”); Farhanah Abd Wahab, Sarimah Abdullah, Jafri Malin Abdullah,

Hasnan Jaafar, Siti Suraiya Md Noor, Wan Mohd Zahiruddin Wan Mohammad, Abdul Aziz Mohamed

Yusoff, John Tharakan, Shalini Bhaskar, Muthuraju Sangu, Mohd Shah Mahmood, Fauziah Kassim,

Md. Hanip Rafia, Mohammed Safari Mohammed Haspani, Azmi Alias, Rogelio Hernández Pando,

Updates on Knowledge, Attitude and Preventive Practices on Tuberculosis among Healthcare Workers, 23

Malay. J. Med. Sci. 25, 30 (“A preliminary study of knowledge, attitudes and practices towards TB

prevention was done in 2013 from two selected hospitals. Five family members were interviewed based

on a questionnaire of knowledge, attitudes and practices (KAP) of TB cases among nurses (30). It was

found that only 20% of them had good knowledge. TB infection is commonly associated with lungs

was correctly answered by 80% of the family members, while 80% said it is treatable and curable.

However, 60% of them were still unaware that TB is caused by a bacterium called Mycobacterium

tuberculosis. All of them believed that smoking (100%) is the main risk factor for TB, apart from alcohol

and drug use (40%), other chronic diseases (20%), overcrowding and malnutrition (20%) and poverty

(20%).”); Adela Ngwewondo, Lucia Nkengazong, Lum Abienwi Ambe, Jean Thierry Ebogo, Fabrice

Medou Mba, Hamadama Oumarou Goni, Nyemb Nyunai, Marie Chantal Ngonde, Jean-Louis Essame

Oyono, Knowledge, attitudes, practices of/towards COVID 19 preventive measures and symptoms: A

cross-sectional study during the exponential rise of the outbreak in Cameroon, 14 PLOS Neglected Tropical

Diseases 9 (2020).

130. See id. at 397 (“While most parents in the fully vaccinated group had no concerns about

the vaccine, half the parents in the partially and non-vaccinated groups had concerns about the vaccine;

most said they were concerned about side effects because it was a new vaccine. Few parents of partially

vaccinated children said they were concerned about side effects because they had heard of a child who

had reacted negatively to vaccination. Parents of non-vaccinated children . . . ‘had serious doubts about

it.’” (quoting parent on non-vaccinated children in Kibera and Lwak)).

131. Malik Peiris & Gabriel M. Leung, What Can We Expect from First-generation COVID-19

Vaccines?, 396 L

ANCET 1467, 1468 (2020), https://www.thelancet.com/action/showPdf?pii=S0140-

6736%2820%2931976-0 [https://perma.cc/RYE2-XRH3 ]; Allison Aubrey, A COVID-19 Vaccine

May Be Only 50% Effective. Is That Good Enough?, NPR (Sept. 12, 2020, 7:00 AM), https://

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134 UC IRVINE LAW REVIEW [Vol. 12:111

Similarly, vaccine-related injuries may be attributable to contamination or

infection from vaccines or syringes used improperly.

132

The introduction of

Johnson & Johnson’s Ebola vaccine candidate into the Democratic Republic of the

Congo was complicated precisely because it required the administration of two

doses two months apart.

133

Nearly all current COVID-19 vaccine candidates require

two doses administered months apart.

C. Informed Consent and Product Labeling

Informed consent is “an autonomous authorization by individuals of a medical

intervention or of involvement in research,” which includes a decision to accept a

health-care worker’s administration of a vaccine.

134

Given the substantial interest by

both manufacturers and third-party sponsors in obtaining as much information as

possible about COVID-19 vaccine planning, implementation, and outcomes, there

is likely to be a high correlation between individuals receiving vaccinations as

patients and subjects of medical research. Informed consent is a process based on

verbal and written communication between patients and health-care workers.

135

www.npr.org/sections/health-shots/2020/09/12/911987987/a-covid-19-vaccine-may-be-only-50-

effective-is-that-good-enough [ https://perma.cc/8DVT-8H3F ]. As of January 13, 2020,

AstraZeneca’s vaccine is seventy percent effective and requires two doses, and Pfizer’s vaccine is

ninety-five percent effective and requires two doses. Compare these to the MMR vaccine which is

ninety-seven percent effective and requires two doses. Aylin Woodward & Shayanne Gal, 3 Coronavirus

Vaccines So Far Seem to Prevent COVID-19. Here’s How Their Efficacy Compares to Vaccines for Flu,

Measles, and More., B

US. INSIDER (Nov. 30, 2020, 2:01 PM), https://www.businessinsider.com/

how-pfizer-coronavirus-vaccine-compares-other-vaccines-2020-11?international=true&r=US&IR=T

[https://perma.cc/5H5U-7ZFV ].

132. World Health Org. [WHO], Vaccine Safety Basics: Learning Manual, at 75 (2013),

https://www.who.int/vaccine_safety/initiative/tech_support/Vaccine-safety-E-course-manual.pdf

[https://perma.cc/AC6U-VMPU ] (outlining common immunization errors: “[r]euse of disposable

syringe or needle leading to contamination of the vial, especially in multi-dose vials; [i]mproperly

sterilized syringe or needle; [c]ontaminated vaccine or diluent”).

133. Helen Branswell, Debate over Whether to Test a Second Ebola Vaccine Turns Acrimonious,

STAT ( July 17, 2019) https://www.statnews.com/2019/07/17/debate-testing-second-ebola-

vaccine/ [ https://perma.cc/N8LX-KMCJ ].

134. K. Moodley, M. Pather & L. Myer, Informed Consent and Participant Perceptions of Influenza

Vaccine Trials in South Africa,

31 J. MED. ETHICS 727, 727 (2005) (“Informed consent is fundamental

to the ethical conduct of randomised controlled trials and is a critical component of the research

process. Defined as ‘an autonomous authorization by individuals of a medical intervention or of

involvement in research,’ the principle of informed consent is enshrined in all major guidelines for the

ethical conduct of biomedical research. Informed consent is a process, based on verbal and written

communication between participants and trial staff (or other individuals recruiting participants). The

main pragmatic worry about informed consent is the different ways in which the process can fail—for

example, because consent is not sought or because participants may not adequately understand the

issues involved. Written trial materials are a central component of the informed consent process that is

required by most major ethical guidelines. To enhance understanding of informed consent forms and

related patient information materials, it is essential that these documents are highly readable.”).

135. Elizabeth Gross Cohn, Haomiao Jia, Winifred Chapman Smith, Katherine Erwin & Elaine

L. Larson., Measuring the Process and Quality of Informed Consent for Clinical Research: Development and

Testing, 38 O

NCOLOGY NURSING F. 417, 418 (2011) (“Results also indicated that a successful consent

process must include, at a minimum, the use of various communication modes (e.g., written, verbal,

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 135

“The main pragmatic concern about informed consent in the vaccine context is the

different ways in which the process can fail—for example, because consent is not

sought or because participants may not adequately understand” the factors involved

in the decision to vaccinate because of a linguistic or other barrier.

136

Informed

consent for licensed and EUA vaccines must include information about the disease

the vaccine is intended to prevent, the risks of contracting that disease without the

vaccine, risks and benefits of the vaccine itself, and who should and who should

not get the vaccine.

137

Liabilities arising from breaches of informed consent and product labeling

accuracy are related. In many situations and contexts, manufacturer liability and

provider liability will be distinct. A manufacturer will provide relevant information

about the vaccine to the public sector or other procuring entity, and unaffiliated

frontline health-care workers will translate product information to recipients.

138

However, vaccine manufacturers are often deeply involved in training health-care

workers or support health-care worker training in partnership with governments

and national and international organizations. Indeed, in many cases, it would be a

best practice for a manufacturer to do so, or at least to monitor point-of-contact

activity, given its interest in effective quality control. If a manufacturer’s product

insert for a COVID-19 vaccine limits its use to specific subgroups, but the

manufacturer simultaneously directly encourages health-care workers or supports

the training of health-care workers to emphasize the known benefits of the

vaccination in a way that deviates from the product labeling or discourages the

dissemination of key evidence gaps in the product’s safety profile, the manufacturer

is potentially liable for violations of the recipient’s informed consent.

139

These liability risks are even more relevant in a manufacturer’s assessment of

wider participation in COVID-19 programs for at least three reasons. First,

asking the participant to repeat what he or she understands), and is likely to require one-on-one

interaction with someone knowledgeable about the study, such as a consent educator.”).

136. Moodley et al., supra note 134, at 727; id.; David J. Diemert, Lucas Lobato, Ashley

Styczynski, Maria Zumer, Amanda Soares & Maria Flavia Gazzinelli, A Comparison of the Quality of

Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and

Developing Countries, PL

OS NEGL’D. TROPICAL DISEASES, Jan. 23, 2017, at 1, 2 (“The informed

consent process depends upon five criteria: the willingness to participate, the capacity to make a

decision, disclosure of information, comprehension, and the decision to participate.”).

137. Heena Kakar, Ramandeep Singh Gambhir, Simarpreet Singh, Amarinder Kaur & Tarun

Nanda, Informed Consent: Corner Stone in Ethical Medical and Dental Practice, 3

J. F

AM. MED. & PRIMARY CARE 68, 68 (2014) (“In medical terms, informed consent implies to

‘providing sufficient information for a patient to make an informed and rational choice, the information

includes the inherent risks and alternatives that a reasonable doctor would provide having regard to the

particular circumstances of the patient.’”).

138. D

IV. OF HEALTH PROMOTION & DISEASE PREVENTION, INST. OF MED., supra note 81,

at 87 (“If a product is not sold directly to the public, but is distributed through intermediaries who can

be expected to know about the product and its risks and to be responsible for informing the ultimate

consumer on its proper use, then the manufacturer does not have a duty to warn the public (although

it does have a duty to warn the intermediaries of risks not known to them).”).

139. See id.

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136 UC IRVINE LAW REVIEW [Vol. 12:111

violations of the principle of informed consent may be serious and widespread in

an accelerated global immunization campaign, and such breaches of informed

consent may also be independent from any injury resulting from product use.

140

Second, the law of informed consent in many jurisdictions is ambiguous, often

forged from existing codes of medical ethics and broadly worded constitutional and

statutory protections.

141

Third, informed consent law is context-specific. Legal

liabilities may turn on the relative age, education, and sophistication of a recipient;

disclosures a health-care worker makes about commercial influences; and rules of

evidence that favor presumption toward the recipient’s or the health-care worker’s

testimony.

142

For example, written communication that is not in the recipient’s

native tongue or is not properly translated may fail to meet the necessary standard

of informed consent. Further, written communication that does not account for

cultural, sociological, and linguistic barriers may not meet standards of sufficient

informed consent.

143

While evidence is sparse, there has been sufficient fieldwork

concluded by public health researchers to establish that the demand for information

by potential immunization target populations may be complex and introduce a

number of difficulties in respecting informed consent law while furthering the goal

of broader immunization efforts.

144

140. Anna Zagaja, Rafał Patryn, Jakub Pawlikowski & Jarosław Sak, Informed Consent in

Obligatory Vaccinations?, 24 MED. SCI. MONITOR 8506, 8507 (2018). (“Currently over 100 million

children are vaccinated each year against infectious diseases such as measles, hepatitis B, diphtheria,

tuberculosis, or polio. According to the European Commission, vaccinations prevent approximately 2.5

million deaths worldwide annually and reduce disease-specific treatment costs. . . . In the case of a

vaccination obligation . . ., individual autonomy is faced off against the state rules and regulations and

a clash between individual’s rights and public safety becomes apparent. Here we consider 2 mechanisms.

The first is protecting individual autonomy (i.e., informed consent); the second is protecting the

common good of society (i.e., public health protection through obligatory vaccinations). Currently, a

lot of pressure is placed on obtaining informed consent from patients prior to invasive procedures,

including vaccinations.”).

141. See, e.g., Med. & Dental Prac. Disciplinary Tribunal v. Okonkwo [2001] AHRLR 159, ¶ 72

(Nigeria) (“The scope and limit of the duty of a practitioner [with respect to informed consent]

. . . cannot be considered in isolation of the right of the patient. Although, there is a dearth of local

authorities in this area of our law, there are ample provisions of our Constitution which show the basis

on which the Court should proceed in these matters.”).

142. See A.O. Adejumo, Sociocultural Factors Influencing Consent for Research in Nigeria: Lessons

from Pfizer′s Trovan Clinical Trial, 11 AFR. J. PSYCH. STUD. SOC. ISSUES 229, 229, (2008).

143. See Stella Burch Elias, Regional Minorities, Immigrants, and Migrants: The Reframing of

Minority Language Rights in Europe, 28 B

ERKELEY J. INT’L L. 261, 311 (2010) (emphasizing the role of

language recognition in achieving full realization of rights in the EU).

144. See Oria et al., supra note 129, at 5 (“Whether or not I accept to vaccinate my child will

depend on the information I receive from those promoting the vaccine. I must be told how safe the

vaccine is, how the vaccine will benefit my child, and from where the vaccine has come.” (quoting a

mother in Kibera)); Julie Leask, Annette Braunack-Mayer & Ian Kerridge, Consent and Public

Engagement in an Era of Expanded Childhood Immunization, 47

J. PAEDIATRICS & CHILD HEALTH 603,

603 (2011) (“For consent to be valid, patients (or their parents) must be competent to make the decision,

sufficiently informed, understand the information provided and be able to act freely and voluntarily.”).

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 137

II.

GLOBAL PANDEMIC RESPONSE DEPENDS ON FAIRNESS TO THOSE

SUFFERING SEVERE SIDE EFFECTS FOLLOWING IMMUNIZATION AND LEGAL

ASSURANCE TO MANUFACTURERS

National and global public health leaders have long known that the response

to a global viral pandemic would require a system to develop and distribute vaccines,

including a system for liability and compensation, but governments and

organizations have done relatively little in light of that knowledge.

The H1N1 pandemic was declared in April 2009, and a vaccine specific to the

pathogen was developed by September 2009.

145

Yet negotiations between

manufacturers, the WHO, and donating and receiving governments over liability

and indemnity delayed the distribution of vaccines until late December 2009/early

January 2010.

146

In October 2014, the WHO; supporting governments and their

agencies (especially the United States, the U.K., and France); and the governments

of Guinea, Liberia, and Sierra Leone convened a meeting to discuss the possibility

of deploying, on an emergency use basis, vaccine candidates against the Ebola virus

disease.

147

Again, the issue of liability and compensation thwarted such deployment,

and the experimental vaccine was never administered outside the clinical

trial context.

148

The failure to resolve the vaccine product liability problem stands in the way

of access to vaccines for the world’s most vulnerable countries. In the wake of

COVID-19, there are two general approaches to procuring vaccines: (1) bilateral

contracts with manufacturers that include assurances against product liability claims

or (2) distribution through the COVAX Facility, an international organization that

invests in vaccine candidates, requires financial commitments from procuring

governments, and ultimately will match recipient governments with manufacturers

when vaccines have been licensed or authorized pursuant to an EUA.

149

By mid-August 2020, the United States had secured 800 million doses of at

least six vaccines in development, with an option to purchase around one billion

more.

150

The U.K. was the world’s highest per-capita buyer, with 340 million doses

145. The 2009 H1N1 Pandemic: Summary Highlights, April 2009-April 2020, CTRS. FOR

DISEASE CONTROL & PREVENTION ( June 16, 2010), https://www.cdc.gov/h1n1flu/

cdcresponse.htm [https://perma.cc/7M8Y-UJY7 ].

146. Halabi, supra note 48, at 207.

147. Ana Maria Henao-Restrepo, Marie-Pierre Preziosi, David Wood, Vasee Moorthy, Marie

Paule Kieny & The WHO Ebola Research, Development Team, On a Path to Accelerate Access to Ebola

Vaccines: The WHO’s Research and Development Efforts During the 2014–2016 Ebola Epidemic in West

Africa, 17 C

URRENT OP. VIROLOGY 138, 139 (2016).

148. Sam Halabi, Andrew Heinrich & Saad B. Omer, No-Fault Vaccine Injury

Compensation – The Other Side of Equitable Access to COVID-19 Vaccines, 383 N

ENG. J. MED. e125(1)–(2) (2020), https://www.nejm.org/doi/pdf/10.1056/NEJMp2030600?article

Tools=true [ https://perma.cc/7C8V-9WJ8 ].

149. Ewen Callaway, The Unequal Scramble for Coronavirus Vaccines, 584 N

ATURE 506 (2020),

https://media.nature.com/original/magazine-assets/d41586-020-02450-x/d41586-020-02450-x.pdf

[https://perma.cc/AYX6-LDMZ ].

150. Id.

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138 UC IRVINE LAW REVIEW [Vol. 12:111

purchased: around five doses for each citizen. The EU nations—which are buying

vaccines as a group—and Japan have locked down hundreds of millions of doses

of vaccines for themselves.

151

A. The Structure of the COVAX Facility

For the vast majority of the world’s governments, bilateral procurement is out

of reach for purely financial reasons.

152

Even for wealthier governments, bilateral

contracts may not be a panacea. As of early January 2021, there have been a limited

number of safe and effective vaccines approved. Vaccines entering Phase III clinical

trials only succeed at about sixteen percent.

153

The solution to the dichotomy

between richer and poorer countries dealing with the vaccine access problem is the

COVAX Facility, an international partnership that convenes wealthy

(“self-financing”) governments interested in diversifying their investments in

potentially successful vaccine candidates, manufacturers of those candidates, and

low- and lower-middle-income countries (“donor countries”) that may offer a

relatively modest up-front commitment but cannot afford bilateral

procurement—certainly not for candidates that may fail.

The COVAX Facility originated within a broader international collaboration

known as the ACT (Access to COVID-19 Tools) Accelerator,

154

an initiative led by

the World Bank, the WHO, G20, European Commission, and a consortium of

major global public health non-governmental organizations including the Bill

& Melinda Gates Foundation and other private donors to advance the goal of

fostering the development and production of diagnostics, therapeutics, and vaccines

to combat the COVID-19 pandemic.

155

The ACT Accelerator, launched in April

2020, is comprised of four pillars: the Diagnostic Pillar supported by the Foundation

for Innovative New Diagnostics (FIND) and the Global Fund to Fight Aids,

Tuberculous, and Malaria (Global Fund); the Therapeutics Pillar supported by

151. Id.

152. Gavin Yamey, Opinion, A Coronavirus Vaccine Should Be for Everyone, Not Just Those

Who Can Afford It, STAT (Mar. 5, 2020), https://www.statnews.com/2020/03/05/coronavirus-

vaccine-affordable-for-everyone/ [ https://perma.cc/2E2L-H3T4 ] (“Without price controls, poor

countries are unlikely to be able to afford or access enough vaccines to protect their populations.”);

Adam Hancock, Why Developing Countries May Be the Last to Get the Vaccine, EU

OBSERVER (May 28,

2020, 07:04 AM), https://euobserver.com/coronavirus/148470 [ https://perma.cc/GC6F-9GYG]

(“To put it bluntly, they simply can’t afford most of the new vaccines being produced.”).

153. Shanay Rab, Afjal, Mohd Javaid, Abid Haleem & Raju Vaishya, An Update on the Global

Vaccine Development for Coronavirus, 14 D

IABETES & METABOLIC SYNDROME: CLINICAL

RSCH. & REVS. 2053, 2053 (2020), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7582051/

pdf/main.pdf [https://perma.cc/WCS9-GA2R].

154. Seth Berkley, COVAX Explained, G

AVI, THE VACCINE ALLIANCE (Sept. 3, 2020),

https://www.gavi.org/vaccineswork/covax-explained [https://perma.cc/SM29-JVVF ].

155. Margaret “Peggy” Hamburg, Former Comm’r, U.S. FDA, Remarks at The Scramble for

Vaccines and the COVAX Facility 3 (Aug. 11, 2020), https://csis-website-prod.s3.amazonaws.com/

s3fs-public/publication/200811_Scramble_Vaccines.pdf [ https://perma.cc/E3CK-GRP2 ]; Donor

Profiles, G

AVI, THE VACCINE ALLIANCE, https://www.gavi.org/investing-gavi/funding/donor-

profiles [ https://perma.cc/F9ZN-YTMM ] (May 28, 2021).

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Unitaid and Wellcome Trust; the Health Systems Pillar supported by the World

Bank, Global Fund, and the WHO; and the Vaccine Pillar supported by Gavi, the

Vaccine Alliance (GAVI), the Coalition for Epidemic Preparedness Innovations

(CEPI), and the WHO.

156

The Vaccine Pillar, “COVAX” or the “COVAX Facility,”

157

was established

in June 2020.

158

It was founded to support the quick and safe development,

manufacture, and delivery of a COVID-19 vaccine worldwide.

159

COVAX aims to

deliver two billion doses of a safe and effective COVID-19 vaccine by the end of

2021.

160

In order to achieve this objective, COVAX invests across a wide portfolio

of vaccine candidates using contributions from eighty-nine self-financing

governments and supporting international organizations and charities and, at the

same time, requiring financial commitments from ninety-two “donor supported”

governments that will receive subsidized prices for doses.

161

Within COVAX, CEPI leads the development and manufacturing

workstream, which supports research and development and manufacturing

expansion through direct financial investments.

162

GAVI is the lead organization

for vaccine procurement and as well as the COVAX Advance Market Commitment

(AMC), which helps finance low- and lower-middle-income countries’ access to a

future COVID-19 vaccine.

163

156. Press Release, World Health Org., ACT-Accelerator Update: Publication of Investment Cases,

( June 26, 2020) [hereinafter ACT-Accelerator Update], https://www.who.int/news-room/detail/26-

06-2020-act-accelerator-update [https://perma.cc/J7YS-CXNJ]; Jonathan C. Carlson, Strengthening the

Property-Rights Regime for Plant Genetic Resources: The Role of the World Bank, 6 T

RANSNAT’L

L. & CONTEMP. PROBS. 91, 112–13 (1996) (identifying the evolving role of the World Bank from

discrete project funding to broader, structural efforts).

157. The Vaccine Pillar is also referred to as “COVAX Facility” or “the Facility” in

online sources.

158. ACT-Accelerator Update, supra note 156.

159. Id.

160. More than 150 Countries Engaged in COVID-19 Vaccine Global Access Facility, supra

note 3.

161. WHO, COVAX Announces Additional Deals, supra note 11. (announcing that

CEPI-Support candidate vaccines include: Invio in United States (Phase II); Moderna in United States

(Phase III); CureVac in Germany (Phase IIB/III); Institute Pasteur/Merck/Themis in France, United

States, Austria (Phase I); AstraZeneca/University of Oxford in U.K., Northern Ireland (Phase III);

University of Hong Kong in China (Preclinical); Novavax in United States (Phase III); Clover

Biopharmaceuticals in China (Phase I); University of Queensland/CSL in Australia (Phase I)).

162. Gavi, the Vaccine Alliance, Report to the Board on COVAX Facility Structure and

Governance, Agenda Item 04b ( July 30, 2020) [hereinafter Gavi Facility Structure and Governance],

https://www.gavi.org/sites/default/files/board/minutes/2020/30-july/04b%20-%20COVAX%20

Facility%20Structure%20and%20Governance_1.pdf [ https://perma.cc/SA9M-X6KE ].

163. Id. at 2–3; Mark Turner, Vaccine Procurement During an Influenza Pandemic and the Role of

Advance Purchase Agreements: Lessons from 2009-H1N1, 11 G

LOB. PUB. HEALTH 322, 327 (2016) (“A

2009 survey by the WHO of pandemic influenza vaccine manufacturers asked whether they would be

willing to reserve 10% of real-time production for acquisition by UN agencies, 14 out of 25 were unable

to meet the request to set aside 10% of their production capacity, because they were constrained by

meeting the volume of vaccines reserved via APAs.”).

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140 UC IRVINE LAW REVIEW [Vol. 12:111

The COVAX Facility itself has no legal personality—it cannot enter into

contracts, and it is not susceptible to legal process in any of the jurisdictions where

its stakeholder organizations reside. GAVI, an international organization

incorporated under the Swiss Host State Act, is the administrator and legal

personality of COVAX.

164

The GAVI Board is responsible for overseeing GAVI’s

role in COVAX, and its CEO, Seth Berkley, coordinates with the leaders of the

other stakeholder organizations in managing GAVI’s role.

165

GAVI’s Market

Sensitive Decision Committee is responsible for reviewing proposed agreements,

and GAVI’s Audit and Finance Committee is responsible for tracking and reviewing

all COVAX funding.

166

GAVI is also responsible for the office of the COVAX Facility. In this role,

GAVI is responsible for negotiating agreements with self-financing countries,

tripartite agreements with multilateral development banks, and agreements with

manufacturers with volume guarantees; managing the vaccine candidate portfolio

(along with other advisors); assembling the Shareholders Counsel and Independent

Product Group; and overseeing all administrative functions.

167

Prior to becoming

the legal personality of COVAX, GAVI spent $1.4 million on setup activities for

COVAX and AMC.

168

As the legal personality, GAVI will seek reimbursement for

these fees through money paid into COVAX by the self-financing participants.

169

The self-financing participants’ COVAX payments are expected to cover all

operating costs, which are expected to be around seven million dollars for the

next year.

170

Additionally, within COVAX, GAVI is responsible for vaccine procurement

and scaling-up delivery of a vaccine for low- and lower-middle-income countries

164. Bd. of Dirs., Review of Decisions of July 30, 2020 Board Meeting, 7 ( July 30, 2020), https:/

/www.gavi.org/sites/default/files/board/minutes/2020/30-july/Board-2020-Mtg-4-Review%20of

%20Decisions.pdf [https://perma.cc/47GN-G5SG].

165. Id. at 11; Dr Seth Berkley, Gavi CEO, GAVI, THE VACCINE ALLIANCE, https://

www.gavi.org/operating-model/gavi-secretariat/seth-berkley [https://perma.cc/2FXB-LUTH ] (June

8, 2021).

166. Gavi Facility Structure and Governance, supra note 162, at 10–11. (noting that the MSDC

is comprised of the “Board Chair . . . the Program and Policy Committee Chair, representatives of

multilaterals, a representative of [the Bill and Melinda Gates Foundation], representatives of

implementing country governments (2), representatives of donor country governments (3), a

representative of the Civil Society Organizations,” and most likely representatives of

self-financing countries).

167. Id. at 11–12 (noting that the Shareholders Council includes representatives from

self-financing countries as well as AMC (financed) countries. The Council provides strategic guidance

for vaccine development and vaccine allocation).

168. Id. at 14.

169. Id.

170. Id.

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 141

through COVAX AMC.

171

All AMC-approved countries

172

are also eligible for cold

chain support to effectively and safely deliver the COVID-19 vaccine.

173

GAVI will

be providing support to AMC countries over the next ten years; however, current

estimations predict that COVAX will only need to be active for the next three

years.

174

Therefore, the AMC program is designed to support lower- and

lower-middle-income countries for an extended period of time—long after the

shut-down of COVAX.

175

AMC was founded through a Stakeholder Agreement with GAVI.

176

Members

of the Stakeholder group include AMC donors such as the United Nations

Children’s Fund (UNICEF), Pan American Health Organization, AMC participant

country representatives, development and regional banks involved in funding, and

private sector and philanthropic donors.

177

The AMC Stakeholder group will be

represented on the COVAX Shareholders Council.

178

The candidate vaccine portfolio is currently being run by CEPI and GAVI.

179

All proposed candidate vaccines are vetted by the Independent Product Group.

180

The Independent Product Group is comprised of five to seven experts who

continuously review data on candidate vaccines, provide a score based on

predetermined criteria in order to make recommendations, and support COVAX’s

portfolio management.

181

High-income, self-financing governments can invest in the diverse portfolio

of candidate vaccines.

182

When self-financing governments join COVAX as

“participating countries,” a binding agreement is established to purchase a

predefined number of doses, determine an initial investment in the program

proportionate to the number of doses requested, and set dose contributions if the

country has entered into other bilateral agreements.

183

Self-financing governments

must also commit to numerous nonfinancial obligations such as supporting the

171. More than 150 Countries Engaged in COVID-19 Vaccine Global Access Facility, supra

note 3.

172. See 172 Countries and Multiple Candidate Vaccines Engaged in COVID-19 Vaccine Global

Access Facility, infra note 195 (listing all AMC-supported countries).

173. More than 150 Countries Engaged in COVID-19 Vaccine Global Access Facility, supra

note 3.

174. Gavi Facility Structure and Governance, supra note 162, at 15.

175. Id.

176. Margaret “Peggy” Hamburg, supra note 155, at 3.

177. Aurélia Nguyen, COVAX Facility Governance Explained, G

AVI, THE VACCINE ALLIANCE

(Nov. 13, 2020), https://www.gavi.org/vaccineswork/covax-facility-governance-explained [https://

perma.cc/45PL-B6N4 ].

178. Gavi Facility Structure and Governance, supra note 162, at 11.

179. Margaret “Peggy” Hamburg, supra note 155, at 3.

180. ACT

ACCELERATOR COVAX PILLAR - INDEPENDENT PRODUCT GROUP, GAVI, THE

VACCINE ALLIANCE 1–2 (2020), https://www.gavi.org/sites/default/files/document/2020/IPG

_Call-for-nominations-8jul.pdf [https://perma.cc/54BF-BVUD ].

181. Id.

182. Berkley, supra note 154.

183. Id.

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142 UC IRVINE LAW REVIEW [Vol. 12:111

movement of a vaccine, fast-tracking licensure of a vaccine, reporting all

epidemiological and virological data, and maintaining transparency about all bilateral

vaccine agreements.

184

The benefit of becoming a participating country includes

access to the diverse candidate vaccine portfolio, which translates to a higher

probability of accessing a COVID-19 vaccine.

185

The WHO is leading the policy and allocation workstream to develop global

policy recommendations and an allocation framework including the Strategic

Advisory Group of Experts (SAGE) on Immunization.

186

The WHO SAGE will

make recommendations and advise on how a vaccine will be distributed within

a country.

187

“COVAX is the only truly global solution to the COVID-19 pandemic.”

188

The COVAX model for vaccine procurement with its portfolio-based investment

advertises a higher probability of a successful vaccine for self-financing countries.

For self-financing countries, COVAX is an insurance policy to enhance a country’s

probability of securing a vaccine beyond the current bilateral agreements.

189

Originally, the COVAX Facility had arrangements for first-wave access for

around two billion doses of COVID-19 vaccine candidates,

190

making COVAX one

of the largest and most diverse vaccine portfolios in the world (export controls

imposed by India during its delta variant wave and problems with J&J procurement

have reduced this initial ambitious goal).

191

AstraZeneca-Oxford University and

Novavax, both vaccine developers, have entered into contracts with COVAX.

192

Serum Institute of India, a manufacturer, has agreed to limit the price of a vaccine

produced by AstraZeneca or Novavax to three dollars per dose for low- and

lower-middle-income countries also through a COVAX agreement.

193

Seven of the

184. Gavi Facility Structure and Governance, supra note 162, at 4.

185. Berkley, supra note 154.

186. Gavi Facility Structure and Governance, supra note 162, at 3.

187. World Health Org. [WHO], Allocation Mechanism for COVAX Facility Vaccines, at 1, 3

(Nov. 12, 2020) [ hereinafter WHO, Allocation Mechanism].

188. More than 150 Countries Engaged in COVID-19 Vaccine Global Access Facility, supra

note 3.

189. Id.

190. WHO, COVAX Announces Additional Deals, supra note 11.

191. Divya Rajagopal, WHO Reviews Nine Vaccine Candidates for COVAX Alliance,

CON. TIMES (Aug. 25, 2020, 6:40 PM), https://economictimes.indiatimes.com/industry/healthcare/

biotech/who-reviews-nine-vaccine-candidates-for-covax-alliance/articleshow/77733032.cms [https://

perma.cc/2WSM-79XA ]. Neha Arora and Krishna N. Das, Rupam Jain, EXCLUSIVE: India unlikely

to resume sizable COVID-19 vaccine exports until October, Reuters, https://

www.reuters.com/world/india/exclusive-india-unlikely-resume-sizable-covid-19-vaccine-exports-until

-october-2021-05-18/ [https://perma.cc/QR2N-RF4Q].

192. Id.

193. Divya Rajagopal, Serum Institute to Price Covid-19 Vaccine at $3 per Dose for India and

Lower Middle Income Nations,

ECON. TIMES (Aug. 7, 2020, 2:41 PM), https://

economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/serum-institute-to-

price-covid-19-vaccine-at-3-per-dose-for-india-and-lower-middle-income-nations/articleshow/77410

667.cms?from=mdr [https://perma.cc/5YCP-Q4RH].

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nine current partnership candidate vaccines are in clinical trials.

194

Eighty-nine

higher-income countries have joined COVAX.

195

These self-financing governments

will help support the ninety-two COVAX AMC member countries, which are

considered “funded” or “donor supported” participants.

196

Some governments, like

France and Germany, have agreed to financially support COVAX although they

will not buy candidate vaccines through the COVAX program, rather, opting to

procure through a EU scheme.

197

Before 2021, the United States rejected COVAX,

declaring, “we will not be constrained by multilateral organizations influenced by

the corrupt World Health Organization and China” but has since decided to

contribute financially to the organization.

198

194. WHO, COVAX Announces Additional Deals, supra note 11.

195. Id.; G

AVI, THE VACCINE ALLIANCE, COVAX: COMMITMENT AGREEMENTS 2–3 (2020),

https://www.gavi.org/sites/default/files/covid/pr/COVAX_CA_COIP_List_COVAX_PR_15-12.

pdf [https://perma.cc/VLK4-LXZX ] (listing the countries that have entered into commitment

agreements with COVAX and agreed to be publicly named: Albania, Andorra, Antigua and Barbuda,

Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Barbados, Belgium, Belize,

Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, Colombia,

Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia,

Finland, France, Georgia, Germany, Greece, Guatemala, Hungry, Iceland, Iran, Iraq, Ireland, Israel,

Italy, Jamaica, Japan, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Libya, Luxembourg, Malaysia, Malta,

Mauritius, Mexico, Monaco, Montenegro, Namibia, Netherlands, New Zealand, North Macedonia,

Norway, Oman, Palau, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania , Saudi Arabia,

Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, St. Kitts and Nevis, Suriname,

Sweden, Switzerland, Trinidad & Tobago, United Arab Emirates, United Kingdom of Great Britain

and Northern Ireland, Uruguay, and Venezuela).

196. Press Release, World Health Org., 172 Countries and Multiple Candidate Vaccines

Engaged in COVID-19 Vaccine Global Access Facility (Aug. 24, 2020), https://www.who.int/news/

item/24-08-2020-172-countries-and-multiple-candidate-vaccines-engaged-in-covid-19-vaccine-global-

access-facility [ https://perma.cc/Q4MZ-XKGG ] (noting that the GAVI board agreed in July 2020

that the following countries will be supported by the COVAX AMC: Low income countries include

Afghanistan, Benin, Burkina Faso, Burundi, Central African Republic, Chad, Democratic Republic of

the Congo, Eritrea, Ethiopia, Gambia, Guinea, Guinea-Bissau, Haiti, Democratic People’s Republic of

Korea, Liberia, Madagascar, Malawi, Mali, Mozambique, Nepal, Niger, Rwanda, Sierra Leone, Somalia,

South Sudan, Syrian Arab Republic, Tajikistan, Togo, Uganda, United Republic of Tanzania and

Yemen. Lower-middle income countries include Angola, Algeria, Bangladesh, Bhutan, Bolivia, Cabo

Verde, Cambodia, Cameroon, Comoros, Congo, Côte d’Ivoire, Djibouti, Egypt, El Salvador, Eswatini,

Ghana, Honduras, India, Indonesia, Kenya, Kiribati, Kyrgyzstan, Lao People’s Democratic Republic,

Lesotho, Mauritania, Micronesia, Moldova, Mongolia, Morocco, Myanmar, Nicaragua, Nigeria,

Pakistan, Papua New Guinea, Philippines, São Tomé and Principe, Senegal, Solomon Islands, Sri Lanka,

Sudan, Timor-Leste, Tunisia, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Zambia

and Zimbabwe. Additional IDA-eligible countries include Dominica, Fiji, Grenada, Guyana, Kosovo,

Maldives, Marshall Islands, Samoa, St. Lucia, St. Vincent and the Grenadines, Tonga and Tuvalu).

197. Andreas Rinke, EXCLUSIVE-Germany Won’t Buy Vaccines Through WHO’s COVAX

Scheme - Sources, R

EUTERS (Sept. 18, 2020), https://www.reuters.com/article/health-coronavirus-

who-germany/exclusive-germany-wont-buy-vaccines-through-whos-covax-scheme-sources-idUSL8N

2GF3JM [https://perma.cc/4JUM-42UT ].

198. Stephanie Nebehay, U.S., Staying in WHO, to Join COVID Vaccine Push for Poor Nations

- Fauci, R

EUTERS ( Jan. 21, 2021, 1:32 AM), https://www.reuters.com/world/china/us-staying-who-

join-covid-vaccine-push-poor-nations-fauci-2021-01-21/ [https://perma.cc/N6SZ-7Z79 ]; Emily

Rauhala & Yasmeen Abutaleb, U.S. Says It Won’t Join WHO-linked Effort to Develop, Distribute

Coronavirus Vaccine, W

ASH. POST (Sept. 1, 2020, 2:42 PM) https://www.washingtonpost.com/

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144 UC IRVINE LAW REVIEW [Vol. 12:111

After the creation of a safe and effective vaccine, the next hurdle COVAX will

face is prioritizing to whom the vaccine will be available in the initial low-production

period.

199

The WHO Allocation Mechanism is responsible for making dose

allocation assessment in line with three goals: to “set . . . overarching principles for

access to and allocation of health products for COVID-19,” to set a “global

framework to ensure equitable and fair access and allocation of COVID-19 health

products,” and to establish “fair and equitable allocation mechanisms for each

product stream.”

200

Currently, the WHO is recommending that priority populations

such as health-care workers, adults over sixty-five, and high-risk adults with

underlying conditions receive one of the first doses of the vaccine.

201

All COVAX

participants (self-financing and funded) will initially receive doses to cover up to

twenty percent of their population through a proportional allocation scheme.

202

Next, all participants will receive weighted allocation beyond twenty percent of their

population.

203

Weighted allocation is invoked if there is a severe supply constraint.

If such a case were to occur, a country’s requested vaccine supply would be

dispersed in accordance with a risk assessment score that evaluates the country’s

“threat and vulnerability,” resulting in a risk rating. A higher risk rating means

vaccine doses will be provided more quickly.

204

As of October 19, 2021, COVAX-facilitated vaccines had shipped 371 million

doses to 144 participants (almost all of which are recognized countries).

205

It is

known that those countries have agreed to indemnify AstraZeneca and Serum

Institute of India, the manufacturers, against liability for adverse events. It is not

known, however, which, if any, steps they have taken to compensate those who may

suffer adverse events among their own populations.

206

world/coronavirus-vaccine-trump/2020/09/01/b44b42be-e965-11ea-bf44-0d31c85838a5_story.html

[https://perma.cc/3Q6X-PGAD ].

199. COVAX,

COVAX, THE ACT-ACCELERATOR VACCINES PILLAR: INSURING

ACCELERATED VACCINE DEVELOPMENT AND MANUFACTURE 1, 3 (2020) [ hereinafter COVAX, THE

ACT-ACCELERATOR VACCINES PILLAR], https://www.gavi.org/sites/default/files/covid/COVAX-

Pillar-background.pdf [https://perma.cc/H4BS-XRDF ].

200. World Health Org. [WHO], WHO Concept for Fair Access and Equitable Allocation of

COVID-19 Health Products, at 1, 6 (2020), https://www.who.int/docs/default-source/coronaviruse/

who-covid19-vaccine-allocation-final-working-version-9sept.pdf [ https://perma.cc/ZMZ4-M7AV ].

201. Id. at 24; See COVAX, the Act-Accelerator Vaccines Pillar, supra note 199 at 3 (noting that

“[p]olicy recommendations will lay out the priority populations” listed to be considered for the first

round of vaccinations).

202. WHO, Allocation Mechanism, supra note 187.

203. Id.

204. Id. at 5.

205. COVAX Vaccine Roll-Out, G

AVI, THE VACCINE ALLIANCE, https://www.gavi.org/

covax-vaccine-roll-out [ https://perma.cc/C3RY-AMHQ ] (last visited Oct. 7, 2021 ).

206. Press Release, World Health Org., First COVID-19 COVAX Vaccine Doses Administered

in Africa (March 1, 2021) https://www.who.int/news/item/01-03-2021-first-covid-19-covax-vaccine-

doses-administered-in-africa [ https://perma.cc/T33D-JWW5].

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 145

B. Liability and Compensation for Vaccine Injury Pose Barriers to both Manufacturer and

Government Participation in COVAX

Despite the tremendous amount of ex ante planning for equitable vaccine

access, there is no resolution at the COVAX Facility about what to do about ex post

liability for vaccine injury.

207

According to internal documents, GAVI has

communicated to donor supported governments that manufacturers will require

“assurances that they won’t face product liability claims over deaths or side effects

from their vaccines.”

208

Thailand, for example, has entered into only a nonbinding

commitment with COVAX and has identified the liability and compensation matter

as material to its decision to participate.

209

Kenya, which is eligible for COVAX

AMC membership,

210

said it was premature to say who should carry the liability for potential

adverse effects but expected the vaccine makers to bear some of the

responsibility, according to Rashid Aman, chief administrative secretary at

the [M]inistry of [H]ealth. . . .

. . . .

This is one of the reasons why the EU has decided not to take delivery

of vaccines through COVAX even though the 27-nation bloc has pledged

money to the facility, [an EU] official said, noting that deals the EU is

separately negotiating with vaccine companies involve clauses that make

firms liable for potential compensation.

211

Manufacturers, for their part, have made it clear that without legal assurances,

they will not ship vaccines to any country, whether or not it participates in

207. GAVI, THE VACCINE ALLIANCE, COVID-19 VACCINE GLOBAL ACCESS (COVAX)

FACILITY, PRELIMINARY TECHNICAL DESIGN: DISCUSSION DOCUMENT 17 ( 2020), https://

www.keionline.org/wp-content/uploads/COVAX-Facility-Preliminary-technical-design-061120-vF.pdf

[https://perma.cc/WM7V-MZL6 ] (“In addition to the pull funding design elements described above,

there are other critical design elements of manufacturer-specific volume guarantees, in the form of

contractual conditions, to be considered, which may include: Meeting minimal and/or preferred

characteristics of normative WHO standards for COVID-19 pandemic response vaccines; Regulatory

approval by a maturity level (ML)3/ML4 regulatory authority and WHO prequalification; Desirability

of vaccine profile potentially influencing size of volume guarantee (e.g. if some product presentations

are unsuitable for LICs / LMICs e.g. intravenous administration or large below-freezing cold chain

requirements); Confirmed ability to export from supplier and host government; If the supplier also

produces routine life-saving antigens, agreement that disruption of supply of other vaccines to

Gavi / LICs / LMICs will be minimized; Agreement with conditions of liability / indemnity mechanisms

being created.” (emphasis added)).

208. Maria Cheng & Lori Hinnant, Push to Bring Coronavirus Vaccines to the Poor Faces Trouble,

NEWS (Sept. 30, 2020), https://apnews.com/article/international-news-lifestyle-business-science-

virus-outbreak-6656cba6143eb097da3dc7c8b360bfa4 [https://perma.cc/M4KP-J4D5 ].

209. Id.

210. See supra note 196 and accompanying text.

211. Francesco Guarascio, Lack of Clarity on Liability Could Cause Delay with WHO

Coronavirus Vaccine Drive, I

NS. J. (Oct. 16, 2020), https://www.insurancejournal.com/news/

international/2020/10/16/586726.htm [ https://perma.cc/SV3E-ALFB ].

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146 UC IRVINE LAW REVIEW [Vol. 12:111

COVAX.

212

AstraZeneca, for example, has stated that in its bilateral contracts, it

has been granted protection from legal claims arising from the use of its products,

as it “cannot take the risk” of liability for side effects.

213

As early as 2006, the

International Federation of Pharmaceutical Manufacturers and Associations

(IFPMA), the global industry lobbying group, stated publicly that it demanded legal

immunity for vaccine adverse events in order to participate in pandemic response.

214

In 2006, the IFPMA, in the wake of a potential H5N1 pandemic, stated

[I]n some countries, existing pharmacovigilance systems may fail to detect

key signals until after the vaccines have already been administered to

hundreds or thousands or millions of people. Many of the individuals

vaccinated could develop medical conditions, by chance alone and

unrelated to the vaccine, at some point following vaccination. It is

inevitable that many will expect to be compensated. This is why [IFPMA]

call(s) for a waiver of liability for the manufacturing and use of

pandemic vaccines.

215

During the 2009–2010 H1N1 pandemic, manufacturers reiterated their

concerns with potential product liability lawsuits, and negotiations regarding

manufacturer indemnification caused substantial delays.

216

In one instance, GSK

required indemnity from the Japanese government, which the government, in turn,

replied it could not provide without a change in its law.

217

Manufacturers expressed

similar concerns with respect to Ebola vaccines in 2014.

218

C. Principles of Fairness and Justice Require Compensation for Those Suffering from

Severe Adverse Events Following Immunization with COVID-19 Vaccines

Globally, “there are three approaches to addressing vaccine injury: patients

with adverse events may bear the costs associated with their injuries; they may seek

compensation through litigation against private-sector actors (principally

manufacturers); or they may seek compensation from publicly supported systems

that draw from public-sector and private-sector contributions.”

219

Each type of

approach is supported by an ethical rationale. The first approach is an “extreme

utilitarian version of the fundamental social contract supporting immunization.”

220

212. See Halabi et al., supra note 148, at e125(2).

213. Burger & Aripaka, supra note 20.

214. Halabi & Monahan, supra note 52, at 136.

215. Id.

216. Id.

217. See Yoko Nishikawa, Japan to Buy H1N1 Flu Vaccine from Glaxo, Novartis, R

EUTERS

(Oct. 6, 2009, 5:28 AM), https://www.reuters.com/article/us-flu-japan/japan-to-buy-h1n1-flu-

vaccine-from-glaxo-novartis-idUSTRE5953AJ20091006 [https://perma.cc/3VYS-T78M ] (noting that

the Japanese government submitted a bill to parliament to compensate patients who suffer side effects).

218. Ben Hirschler & Stephanie Nebehay, Drugmakers May Need Indemnity for Fast-Tracked

Ebola Vaccines, R

EUTERS (Oct. 23, 2014, 1:51 AM), https://www.reuters.com/article/us-health-

ebola-vaccine-idUSKCN0IC0TZ20141023 [https://perma.cc/NA2T-3YZY ].

219. Halabi & Omer, supra note 26.

220. Id.

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 147

“From the claimant’s perspective, litigation is adversarial, protracted, uncertain, and

requires that an attorney agree to take the case, which may pose a considerable

obstacle for claimants with low earnings or fairly minor injuries.”

221

It effectively

pushes the costs of herd immunity onto innocent parties.

222

In this utilitarian view,

the benefits of vaccination so outweigh the risks that communities accept that some

individuals will experience adverse events in return for herd immunity.

223

“The second approach, requiring manufacturers to pay, is based on the

integrity and dignity of the individual person—those whose products cause injury

should make whole those individuals who experienced an adverse event.”

224

“Vaccine manufacturers dislike tort because of the uncertainty involved in allowing

juries to determine injury causation and damages awards. Even if catastrophically

large awards rarely occur, the threat of them weighs heavily on manufacturers and

their insurers.”

225

These two approaches are commonly applied worldwide, yet they

“destabilize the effort to promote immunization by failing fundamental tests for

fairness” by (1) requiring people with few resources to pay for serious (if rare)

injuries and (2) introducing economic uncertainty.

226

The third approach, a no-fault compensation system for adverse events

attributed to vaccination, balances these competing principles. Under a

no-fault vaccine injury compensation system, governments compensate

individuals who are harmed by properly manufactured vaccines instead of

requiring them to use legal or other processes against manufacturers. A

no-fault system acknowledges that a community that promotes

immunization, knowing individuals will be injured, must share the burden

of the cost of injuries. This approach also acknowledges that

manufacturers are a critical part of vaccine access and that they must have

a basic level of economic certainty. It fulfills the utilitarian and

communitarian expectations of a democratic society.

227

Over time, no-fault vaccine injury compensation systems have become a

cornerstone of advanced public health systems, first in wealthier countries, but

221. Michelle M. Mello, Rationalizing Vaccine Injury Compensation, 22 BIOETHICS 32,

33 (2008).

222. Cristina Carmody Tilley, Tort Law Inside Out, 126 Y

ALE L.J. 1320, 1392–93 (2017)

(analyzing community perceptions of mandated vaccines).

223. Id.

224. Halabi & Omer, supra note 26; R

ESTATEMENT (THIRD) OF TORTS: PRODS. LIAB. § 1

(AM. L. INST. 1998) (“One engaged in the business of selling or otherwise distributing products who

sells or distributes a defective product is subject to liability for harm to persons or property caused by

the defect.”); G

UIDO CALABRESI, THE COSTS OF ACCIDENTS: A LEGAL AND ECONOMIC

ANALYSIS (1970).

225. Mello, supra note 221.

226. Halabi & Omer, supra note 26; Adrien Katherine Wing, Conceptualizing Global Substantive

Justice in the Age of Obama, 13 J. G

ENDER RACE & JUST. 705, 712 (2010) (“Justice issues transcend

borders. We are beyond the time when we can segregate national and international issues.”).

227. Halabi & Omer, supra note 3. Cf. Gregory H. Shill, Should Law Subsidize Driving?, 95

N.Y.U.

L. REV. 498, 574 (2020) (“No-fault insurance, which works a partial preemption of tort suits,

adds an additional layer of subsidy for driving via torts.”).

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148 UC IRVINE LAW REVIEW [Vol. 12:111

increasingly in low- and lower-middle-income countries such as Nepal and

Vietnam.

228

The first such system was adopted in Germany in 1961 and has

expanded to thirty-nine countries as well as the Canadian province of Quebec.

229

III.

SOLVING THE COVID-19 VACCINE PRODUCT LIABILITY PROBLEM

So far, solutions to the vaccine product liability problem have been achieved

only by a small number of wealthy countries and a handful of middle-income

countries. Those solutions follow one of two approaches. First, the domestic law of

the procuring government provides separately for legal immunity to manufacturers

and a compensation system for those suffering side effects. Second, governments

and manufacturers agree through contract on the division of liabilities between

them, with presumptive recourse to litigation for those suffering severe vaccine side

effects. The first approach is adopted by the United States under its PREP Act,

detailed below. The second approach has been adopted by the EU, which has

offered varying levels of liability protection to AstraZeneca and Sanofi based on

price per dose of vaccine.

230

But the need to compensate those suffering severe side effects following

immunization is worldwide, especially through COVAX, as is the need to provide

manufacturers legal certainty regarding their participation. This Part provides

solutions for the rest of the world by combining together three

approaches: requiring existing national no-fault systems to incorporate injuries

attributable to COVID-19 vaccines distributed through COVAX, leveraging an

existing small-scale insurance regime administered by the WHO, and constructing

a system for no-fault vaccine injury compensation using mass claims models

deployed after the Deepwater Horizon oil spill in the Gulf of Mexico and the

compensation systems used after the Boeing 737 mass casualty airplane

crash events.

A. No-Fault Compensation for Vaccine Injury

1. No-Fault Compensation Systems for Public Health Emergencies

Some jurisdictions, like the United States, have extended immunity against

legal claims related to the manufacturing, testing, development, distribution, and

228. Randy G. Mungwira, Christine Guillard, Adiela Saldaña, Nobuhiko Okabe, Helen

Petousis-Harris, Edinam Agbenu, Lance Rodewald & Patrick L. F. Zuber, Global Landscape Analysis

of No-fault Compensation Programmes for Vaccine Injuries: A Review and Survey of Implementing

Countries, PLOS ONE, May 21, 2020, at 5; see Josephine Gittler, Controlling Resurgent

Tuberculosis: Public Health Agencies, Public Policy, and Law, 19 J.

HEALTH POLS., POL’Y & L. 107,

139–40 (1994) (analyzing public health measures as part of broader social safety planning).

229. Looker & Kelly, supra note 117, at 371–72.

230. Francesco Guarascio, Exclusive: AstraZeneca Gets Partial Immunity in Low-cost EU

Vaccine Deal, R

EUTERS (Sept. 24, 2020, 11:14 PM), https://www.reuters.com/article/health-

coronavirus-eu-astrazeneca/exclusive-astrazeneca-gets-partial-immunity-in-low-cost-eu-vaccine-deal-i

dUSL5N2GK3NE [https://perma.cc/3BSW-2AMP ].

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 149

administration of COVID-19 vaccines.

231

The law provides for a publicly funded

and administered program of compensation for those suffering severe side effects.

The Public Readiness and Emergency Preparedness (PREP) Act was enacted on

December 30, 2005.

232

The purpose of the Act is to encourage companies to

promptly release medical countermeasures during public health emergencies.

233

The

PREP Act precludes liability for defects in diagnostics, therapeutics, and vaccines

under both federal and state law for any loss “caused by, arising out of, or resulting

from” the application of a “covered countermeasure.”

234

PREP Act declarations

have been made for H1N1, Ebola, botulism toxin, anthrax, smallpox, and acute

radiation syndrome.

235

For COVID-19, a “covered countermeasure” is any antiviral, any other drug,

any biologic, any diagnostic, any other device, any respiratory protective device, or

any vaccine, used (a) to treat, diagnose, cure, prevent, mitigate or limit the harm

from COVID-19, or the transmission of SARS-CoV-2 or a virus mutating

therefrom, or (b) to limit the harm that COVID-19, or the transmission of

SARS-CoV-2 or a virus mutating therefrom, might otherwise cause. A “covered

countermeasure” is also any device used in the administration of any such product

and all components and constituent materials of any such product that has been

authorized pursuant to a declaration by the Secretary of U.S. Health and Human

231. See generally Looker & Kelly, supra note 117.

232. Notice of Amendment and Republished Declaration Under the Public Readiness and

Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of

the Declaration, 85 Fed. Reg. 79190, 79191 (Dec. 9, 2020).

233. K

EVIN, J. HICKEY, CONG. RSCH. SERV., LSB10443, THE PREP ACT AND

COVID-19: LIMITING LIABILITY FOR MEDICAL COUNTERMEASURES 1 (2021), https://

crsreports.congress.gov/product/pdf/LSB/LSB10443 [ http://web.archive.org/web/202109280050

52/https://crsreports.congress.gov/product/pdf/LSB/LSB10443].

234. Declaration Under the Public Readiness and Emergency Preparedness Act for Medical

Countermeasures Against COVID-19, 85 Fed. Reg. 15198, 15200 (Mar. 17, 2020).

235. Ebola Virus Disease Vaccines, 79 Fed. Reg. 73314 (Dec. 10, 2014); HHS Secretary’s

Declaration for Utilization of Public Readiness and Emergency Preparedness Act for Botulism

Countermeasures, 73 Fed. Reg. 61864 (Oct. 17, 2008); HHS Secretary’s Declaration for Utilization of

Public Readiness and Emergency Preparedness Act for Anthrax Countermeasures, 73 Fed. Reg. 58239

(Oct. 6, 2008); HHS Secretary’s Declaration for Utilization of Public Readiness and Emergency

Preparedness Act for Smallpox Countermeasures, 73 Fed. Reg. 61869 (Oct. 17, 2008); Letter from Brian

L. Strom, Kristine M. Gebbie, Robert B. Wallace & Committee on Smallpox Vaccination Program

Implementation to Dr. Julie Gerberding ( Jan. 16, 2003), in T

HE SMALLPOX VACCINATION

PROGRAM: PUBLIC HEALTH IN AN AGE OF TERRORISM 123, 123–159 (Alina Baciu, Andrea Pernack

Anason, Kathleen Stratton & Brian Strom eds., 2005); HHS Secretary’s Declaration for Utilization of

Public Readiness and Emergency Preparedness Act for Acute Radiation Syndrome, 73 Fed. Reg. 61866

(Oct. 17, 2008); David W. Ogden, Bruce S. Manheim Jr., Sean Hayes & Ariel Dobkin,

COVID-19: Immunity Under the PREP Act: When Does It Apply to Private Sector Efforts to Help

Combat COVID-19?, W

ILMERHALE (Mar. 30, 2020), https://www.wilmerhale.com/en/insights/

client-alerts/20200330-immunity-under-the-prep-act-when-does-it-apply-to-private-sector-efforts-to-

help-combat-covid19 [https://perma.cc/C3SL-ZGJ8].

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150 UC IRVINE LAW REVIEW [Vol. 12:111

Services (HHS).

236

The HHS Secretary, Alex Azar, issued the initial PREP Act

declaration covering COVID-19 vaccines on March 10, 2020.

237

In order to qualify

for PREP Act immunity, a covered countermeasure, including a COVID-19

vaccine, must be approved by the U.S. FDA, either pursuant to conventional

licensure or under an EUA.

238

Manufacturers and distributors are immune from

liability regardless of the geographical area where the countermeasure was

administered or used.

239

As part of the same law limiting manufacturer liabilities for covered

countermeasures, the United States provides for a system of compensation for

those suffering severe side effects. The Countermeasures Injury Compensation

Program (CICP) was created by the PREP Act.

240

Should an individual experience

an injury as a result of the use of a covered countermeasure, he or she is allowed to

submit a claim to the Health Resource and Services Administration (an agency

within the HSS). A claimant must complete a Request for Benefits form and submit

medical evidence within a year of being administered or using the

countermeasure.

241

Once a claim has been submitted, it is reviewed by medical staff

within the program to determine a causal link.

If HHS has published an injury table for the covered countermeasure, the

claimant is entitled to a presumption of causation. If not, the claimant must prove

causation through “compelling” evidence.

242

Once causation is established,

claimants are compensated.

243

There is no adversarial process or presentation of

further evidence to a court or special tribunal.

244

The CICP has received 485 claims

since it began accepting claims related to H1N1 vaccines in 2010.

245

Of those claims,

236. 42 U.S.C. § 247d-6d(i)(1) (2020); ROBERT P. CHARROW, U.S. DEP’T OF HEALTH

& HUM. SERVS., ADVISORY OPINION ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS

ACT AND THE MARCH 10, 2020 DECLARATION UNDER THE ACT (May 19, 2020).

237.

HICKEY, supra note 233, at 2.

238. Ogden et al., supra note 235.

239. Notice of Declaration Under the Public Readiness and Emergency Preparedness Act for

Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198, 15201 (Mar. 17, 2020).

240. 42 U.S.C. § 247d-6d (2020).

241. Filing for Benefits, HRSA, https://www.hrsa.gov/cicp/filing-benefits [ https://

perma.cc/4FCK-2ZFQ ] (last visited Apr. 2020 ).

242. Peter H. Meyers, Fixing the Flaws in the Federal Vaccine Injury Compensation Program, 63

DMIN. L. REV. 785, 835 (2011) (citing 42 U.S.C. §§ 239a(c)(2), 247d-6e(b)(4)) (“[C]ompelling, reliable,

valid, medical and scientific evidence.”).

243. See Robert Roos, HHS: 386 Injury Claims Filed Over H1N1 Countermeasures, CIDRAP

(Mar. 16, 2011), https://www.cidrap.umn.edu/news-perspective/2011/03/hhs-386-injury-claims-

filed-over-h1n1-countermeasures [https://perma.cc/29LU-HWCN]; Mungwira et al., supra note 228,

at 9.

244. See HRSA, supra note 241.

245. Tom Hals, COVID-19 Era Highlights U.S. ‘Black Hole’ Compensation Fund for Pandemic

Vaccine Injuries, R

EUTERS (Aug. 21, 2020, 4:08 AM), https://www.reuters.com/article/us-health-

coronavirus-vaccines-liability/covid-19-era-highlights-u-s-black-hole-compensation-fund-for-pandemic

-vaccine-injuries-idUSKBN25H1E8 [ https://perma.cc/HFC6-Z8QE].

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thirty-nine individuals have received compensation with a total $5.7 million paid.

246

Of the 485 claims filed with the CICP, 386 were related to the H1N1 vaccine.

247

The United States is the only country in the world with such an extensive

system for covering manufacturers of emergency deployed vaccines and providing

for ex post compensation.

248

2. Adapting No-Fault Compensation Systems for Routine Immunizations

Similar no-fault systems for routine immunization existed before COVID-19

for twenty-five countries (including the United States) and the province of Quebec

in Canada.

249

Fourteen additional countries have adopted such systems pursuant to

the COVID-19 pandemic. The first prong of solving the COVID-19 vaccine

product liability problem requires that countries with established no-fault systems

agree to incorporate COVID-19 vaccines into their no-fault systems if they receive

vaccines through the COVAX Facility.

250

All of these systems provide a schedule

of automatic compensation based on the injury without establishing fault. None of

these systems require the vaccine recipient to prove the maker of the vaccine

was negligent.

251

There are variations in how the programs are funded, who is eligible, who

administers the program, and what limits exist on collection for the claimant should

they be successful. Any one of the given models may be incorporated into a global

system run by the COVAX Facility, but for those countries with pre-existing

systems, the most straightforward approach is to require those countries to affirm

that COVID-19 vaccines with a table of compensable injuries generated from Phase

III trials and ongoing monitoring and experience will be incorporated into

their systems.

a. Funding

In most countries with no-fault systems, the government stands in as the

defendant, and as a result, most programs are government-funded.

252

Fifteen

246. Id.

247. See Roos, supra note 243.

248. NICHOLAS M. PACE & LLOYD DIXON, RAND CORP., COVID-19

ACCINATIONS: LIABILITY AND COMPENSATION CONSIDERATIONS CRITICAL FOR A SUCCESSFUL

CAMPAIGN 6 (2020), https://www.rand.org/content/dam/rand/pubs/perspectives/PEA700/

PEA761-1/RAND_PEA761-1.pdf [ https://perma.cc/9FJ2-JZ4F ] (“Although some countries have

legal processes through which vaccine-injury claims can be addressed outside traditional litigation, few

countries provide any level of immunity to entities and individuals within the supply chain that

compares with the sweeping protections available under PREP.”).

249. Mungwira et al., supra note 228, at

1, 4–5.

250. See id. at 9; INST. OF MED., Liability for the Production and Sale of Vaccines, in VACCINE

SUPPLY AND INNOVATION 85, 85 (1985) (“Manufacturers have complained about the costs, the

unpredictability of the law, and the unavailability and cost of insurance.”).

251. Mungwira et al., supra note 228, at 8.

252. J

ENNIFER KEELAN & KUMANAN WILSON, DESIGNING A NO-FAULT VACCINE-INJURY

COMPENSATION PROGRAMME FOR CANADA: LESSONS LEARNED FROM AN INTERNATIONAL

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152 UC IRVINE LAW REVIEW [Vol. 12:111

current systems are funded by their governments, while eight fund themselves from

other sources, including levies on manufacturers.

253

For example, France, Denmark, Quebec, and Italy all use general tax revenues

to pay damage awards to injured parties.

254

In Sweden, Taiwan, and Norway,

manufacturers pay a premium to fund the no-fault program.

255

While administered

at the government level, Norway’s program is actually funded by a special insurance

organization called the Drug Liability Association.

256

Membership in this

association is mandatory for any drug producer in Norway.

257

Members pay for an

insurance regime that is used to fund the no-fault program.

258

The United States collects a $0.75 levy on each dose (so MMR, for example,

would be $2.25) of the vaccine sold, then funds the no-fault program with the

levy.

259

The Vaccine Injury Compensation Program trust holds approximately three

billion dollars from this levy with about $150 million being deposited every year.

260

b. Eligibility

With respect to eligibility, fifty-seven percent of no-fault systems compensate

injuries for those vaccines which are registered and recommended by their

respective governments.

261

This is the broadest category of vaccines, encompassing

any vaccine the government (through public health agencies) may recommend.

However, a minority of programs (twenty-two percent) only cover those vaccines

that are mandated or recommended through law.

262

The U.K. and Quebec both

only cover vaccines which are specifically listed in the legislation establishing the

no-fault program.

263

Eligibility provisions of national regimes would require

amendment for COVID-19 vaccines in some cases.

264

All no-fault programs maintain at least some threshold of injury for

compensation.

265

Quebec allows for any serious injury, for example, while the

ANALYSIS OF PROGRAMMES 2, 10 (2011), https://munkschool.utoronto.ca/wp-

content/uploads/2012/07/Keelan-Wilson_NoFaultVaccine_CPHS_2011.pdf [ https://perma.cc/

CJ4H-2MHV ].

253. Mungwira et al., supra note 228, at 6, 10.

254. Id. at 5–6.

255. K

EELAN & WILSON, supra note 252, at 3.

256. Mungwira et al., supra note 228, at 6.

257. L

EGEMIDDELANSVARSFORENINGEN, LIABILITY INSURANCE IN CONNECTION WITH

CLINICAL TRIALS OF DRUGS 1 (2019), http://www.laf.no/dm_documents/8366497_1_Liability_

insurance_in_connection_with_clinical_trials_of_drugs_QPgvg.PDF [ https://perma.cc/8ALU-KUYV ].

258. Id. at 1–2.

259. Mungwira et al., supra note 228, at 6.

260. Nora Freeman Engstrom, A Dose of Reality for Specialized Courts: Lessons from the VICP,

163 U.

PA. L. REV. 1631, 1660, 1713 (2015).

261. Mungwira et al., supra note 228, at 6.

262. Id.

263. Id.

264. See id.

265. Id. at 7.

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 153

U.K. offers compensation if the vaccine is solely responsible for causing sixty

percent or more disability in an individual.

266

All current programs also require some sort of causal link to be established

between the injury and the vaccine.

267

Generally, no-fault systems require a

balance-of-probabilities test that, in the United States, is understood as “more likely

than not” or through a “preponderance of the evidence” analysis.

268

c. Administration

Most (sixty-five percent) of current no-fault programs are administered at the

national government level through public bureaucracies.

269

Few programs, such as

China and Switzerland, administer their programs at the provincial level.

270

Finland and Sweden both administer their no-fault programs through a private

drug insurance scheme. Sweden’s drug companies have private insurance to which

they pay premiums. Those premiums are then used to fund a program, with injured

parties filing claims with insurers.

271

d. Limits on Compensation

Systems vary with respect to those damages qualifying for compensation.

Some programs include medical costs, lost earnings, pain and suffering

compensation, emotional distress, and even loss of earning capacity.

272

Quebec, for

example, refers to an automobile insurance act in setting claimant compensation

and pays claimants the same as automobile accident victims.

273

In the U.K., compensation is set at £120,000.

274

This amount reflects the

lifelong support those on disability already receive from the British government,

while also attempting to “ease the burden of affected families.”

275

266. KEELAN & WILSON, supra note 252, at 10.

267. Mungwira et al., supra note 228, at 8.

268. Id.

269. Mungwira et al., supra note 228, at 5.

270. Id. at 6. In 2014, China required all thirty-one provinces to implement the compensation

programme for vaccine injuries. Administration of the programme involves all levels of

government: “filing of claims and causality assessment of events is done at district or county level;

operational procedures for compensation are set at province level and general vaccine injury

compensation policies including definitions of what constitutes a vaccine injury are determined at the

central government level.” Id. The programme was enacted by the central government but is actually

run by local governments. Each province, autonomous region, or municipality directly under the central

Chinese government needs to formulate its specific local regulations for compensation for AEFI.

Lanfang Fei & Zhou Peng, No-Fault Compensation for Adverse Events Following Immunization: A Review

of Chinese Law and Practice, 25 M

ED. L. REV. 99, 103–04 (2017).

271. KEELAN & WILSON, supra note 252, at 2, 10.

272. Mungwira et al., supra note 228, at 8.

273. Id.

274. K

EELAN & WILSON, supra note 252, at 18.

275. Id.

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154 UC IRVINE LAW REVIEW [Vol. 12:111

B. Expanding Small-Scale Insurance Plans

While thirty-nine countries, including Nepal, the Philippines, and Vietnam,

maintain no-fault vaccine injury compensation systems that could be used for

COVID-19 vaccines, the vast majority of countries do not. The second prong of a

comprehensive solution to the vaccine injury product liability problem is the use of

small-scale insurance regimes that exist under the auspices of the WHO that may

be expanded in response to the COVID-19 pandemic.

The WHO maintains a small-scale insurance regime for EUA vaccines that it

procures and distributes. The plan for a no-fault insurance regime followed the

2014–2016 West Africa Ebola public health emergency. While there was a leading

vaccine candidate—rVSV-ZEBOV, now marketed as Ervebo—that had been

developed over a fifteen-year period before the outbreak, there was no system for

addressing liability and compensation if it were to be deployed on an emergency use

basis.

276

One of the most afflicted countries refused to accept responsibility for

product liability claims, and the manufacturer limited its participation to the

sponsorship of clinical trials organized after the peak of the epidemic had passed.

277

Given the uncertainty about permanent licensure, the WHO sought an

insurance product that would apply after the clinical trial stage—where insurance is

relatively easy to obtain and inexpensive—and full licensure—when manufacturers

are expected to assume liability for their products.

278

276. Ann Maria Henao-Restrepo, Marie-Pierre Preziosi, David Wood, Vasee Moorthy Marie

Paule Kieny & the WHO Ebola Research, Development Team, On a Path to Accelerate Access to Ebola

Vaccines: The WHO’s Research and Development Efforts During the 2014–2016 Ebola Epidemic in West

Africa, C

URRENT OP. VIROLOGY, Apr. 2016, at 138, 140–41, https://www.sciencedirect.com/

science/article/pii/S1879625716300384 (click “View PDF”) [https://perma.cc/22BT-TT9X ].

277. See Sam Halabi, Andrew Heinrich & Saad B. Omer, No-Fault Compensation for Vaccine

Injury—The Other Side of Equitable Access to Covid-19 Vaccines, 383 New England Journal of Medicine

23 (2020).

278. World Health Org. [WHO], Workshop on Expanded Access to Experimental Ebola Vaccines

During Outbreaks, at 21–22 (2017) [hereinafter WHO, Experimental Ebola Vaccines]

https://www.who.int/blueprint/expanded-access-ebola-vaccines.pdf [ https://perma.cc/3X8W-

4MBR ] (“The ultimate objective of this special insurance product is to facilitate emergency response

action and timely deployment of experimental vaccines in the event of infectious disease outbreaks for

which no licensed vaccine exists. While manufacturers of experimental vaccines will be required to

assume liability arising from failure to manufacture their product in accordance with current Good

Manufacturing Practices and agreed specifications, recipient countries will (as was the case during the

2014–2016 Ebola outbreak) as a condition for receiving experimental vaccine be required to assume

liability and indemnify WHO, donors and manufacturers for other risks arising out of the use of the

product. At the same time, WHO would obtain insurance coverage for the benefit of recipient

countries, to provide compensation to individuals who suffer from serious AEFI. The insurance would

have two levels: (i) a first level based on an annual premium, to keep the insurance open over time; and

(ii) a second level of insurance to be obtained when an outbreak occurs, with a premium based on

agreed criteria (vaccine safety profile, Gross Domestic Product of the country where the experimental

product would be used and the number of people that would receive the product). The insurance could

also include a certain coverage for manufacturers, i.e. in case an individual refuses to accept the

compensation offered under the insurance and wishes to pursue a liability claim against the

manufacturer in a court of law (or any similar forum).”).

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 155

The WHO scheme insures against serious injuries resulting from experimental

vaccines that the WHO administers on an emergency use basis.

279

The WHO must

declare an Emergency Use Assessment Listing for vaccines that are still

experimental or have not been completely clinically verified in emergency

situations.

280

Granting such an assessment listing expedites immunization response

during disease outbreaks for which no licensed vaccine currently exists. However,

risks naturally occur alongside such an assessment listing, as the vaccine is still

relatively untested and can present unknown dangers when deployed widely to all

types of people with varying health conditions.

281

So, the WHO provides, through

a private insurer, compensation and protection for those countries receiving and

using an experimental vaccine, as well as legal protection as an incentive to

manufacturers to donate needed immunizations.

282

This insurance is procured through both an annual premium and a heightened

cost in the event of an outbreak. The premium during an outbreak is based on

criteria such as the GDP of the country where the vaccine is being deployed. This

insurance compensates for immunization-caused injuries within the country in

which they occur.

283

While manufacturers of experimental vaccines are required to

assume liability arising from failure to manufacture their product in accordance with

current good manufacturing practices and agreed specifications, recipient countries,

as a condition for receiving the experimental vaccine, must assume liability and

indemnify the WHO, donors, and manufacturers for other risks arising out of the

use of the product in order to receive the benefits of the insurance policy.

284

The

insurance also includes contingent coverage for manufacturers, “i.e. in case an

individual refuses to accept the compensation offered under the insurance and

wishes to pursue a liability claim against the manufacturer in a court of law (or any

similar forum).”

285

The biggest limitation in this plan is its scope. The current plan only grants

coverage to countries for a specific vaccine when the WHO specifically brands the

vaccine as emergency use and then distributes it. Although the WHO has expanded

its current mechanism for COVID-19 in partnership with ESIS, Inc., a unit of

Chubb Insurance, it has also made clear that “dozens of middle-income countries,

such as South Africa, Lebanon, Gabon, Iran and most Latin American states, [will]

not be offered this protection.”

286

Yet there are large insurers who may be able to

279. Id.

280. Regulation and Prequalification: Emergency Use Listing, W

ORLD HEALTH ORG., https://

www.who.int/teams/regulation-prequalification/eul [ https://perma.cc/CD3W-DHT6 ] ( last visited

July 13, 2021).

281. WHO, Experimental Ebola Vaccines, supra note 278.

282. Id.

283. Id.

284. Id. at 21.

285. Id. at 22.

286. Francesco Guarascio, WHO to Form COVID Insurance Scheme for Vaccine Side-Effects in

Poor Nations, I

NS. J. (Oct. 29, 2020), https://www.insurancejournal.com/news/international/2020/

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156 UC IRVINE LAW REVIEW [Vol. 12:111

scale up the WHO system for COVID-19 vaccines including Allianz Multinational,

Chubb, Swiss Re, and Zurich Multinational.

287

In 2011, Swiss Re opened its

subsidiary, Corporate Solutions, whose focus is on underwriting risk for medium

and large corporations.

288

The Corporate Solutions arm of the company offers

coverage in about 150 countries.

289

C. Centralized Mass Claims Administration

There are currently no-fault vaccine injury compensation programs across

twenty-five of the 217 countries currently listed by the World Bank.

290

The

twenty-five countries with compensation programs include a handful of large

countries (including the United States and China), but the 192 countries without any

form of compensation programs encompass about sixty-six percent of the human

population.

291

There are currently 5.03 billion people living without a no-fault

compensation program for their vaccine injuries.

292

As noted above, the WHO

insurance regime is small in scale, perhaps at this point only able to cover

one-to-five million individuals.

There is, therefore, a need to provide a mechanism through the COVAX

Facility or a system of country opt-outs that satisfies manufacturer demands for

indemnity or immunity from legal claims. The models below may serve as effective

options for running a no-fault compensation system out of the COVAX Facility.

As with the no-fault systems described above, funding for a centrally administered

system could be from funds already earmarked for COVAX purposes or a $0.05 or

$0.10 levy per dose. Given the billions of doses to be administered, even a small

levy would quickly generate a pool of resources for compensation.

1. Deepwater Horizon Oil Spill

On April 20, 2010, an explosion occurred on the Deepwater Horizon, an

offshore oil drilling rig owned by Transocean Ltd. [BP’s offshore drilling

10/29/588706.htm [https://perma.cc/SSB7-EQUR ]. See also covaxclaims.com [ https://

perma.cc/G8AK-8XBY ] for the specifics of the expanded WHO system.

287. See, e.g., About Us, S

WISS RE CORP. SOLS., https://corporatesolutions.swissre.com/about-

us.html [ https://perma.cc/5CM6-K23M] ( last visited July 13, 2021 ); Brian Till, How Drug Companies

Keep Medicine Out of Reach, A

TLANTIC (May 15, 2013), http://www.theatlantic.com/health/archive/

2013/05/how-drug-companies-keep-medicine-out-of-reach/275853/ [ https://perma.cc/CV8F-9K6S].

288. SWISS RE, 2011 BUSINESS REPORT 13 (2011), https://www.swissre.com/dam/

jcr:1651ad7b-3bff-457b-a59a-b1756611c7f9/2011_AR_business_report_en.pdf [https://perma.cc/

BCA9-YF8Q].

289. International Programs, S

WISS RE CORP. SOLS., https://corporatesolutions.swissre.com/

insurance-solutions/international-programs.html [ https://perma.cc/9W54-YGKP] (last visited July

13, 2021).

290. See Mungwira et al., supra note 228; Population, Total, W

ORLD BANK, https://

data.worldbank.org/indicator/SP.POP.TOTL [https://perma.cc/6VXG-KEE2 ] ( last visited July 13,

2021).

291. Id.

292. See id.

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 157

contractor], which resulted in, among other things, the deaths of eleven

crewmen and the discharge of oil into the Gulf of Mexico for several

months. The Spill dwarfed the 1989 Exxon Valdez oil spill (which gave rise

to the Oil Pollution Act of 1990) both in terms of the amount of oil

discharged and the extent of the impact.

293

The resulting legal claims were massive in number and scope but were

effectively limited by claims processes required under U.S. law. Under the Oil

Pollution Act of 1990 (OPA), BP (lessor of the Deepwater Horizon drilling

platform) was designated the responsible party for the spill by the United States

Coast Guard.

294

Under the OPA, responsible parties must construct a claims

process against themselves for all affected by the spill. The United States negotiated

with BP to create a twenty-billion-dollar trust to finance the claims resulting from

the spill.

295

As a part of these negotiations, the Gulf Coast Claims Facility (GCCF)

was established.

296

The GCCF was created to process claims in a neutral and efficient manner.

First, a claimant’s eligibility was determined through a classification analysis.

Claimants would bring their claims under five categories: removal and cleanup

costs, real or personal property damage, lost profits or earning capacity, subsistence

use of natural resources, or physical injury or death.

297

The GCCF only paid out

compensation to those injuries proximately caused by the oil spill.

298

Once a

claimant was determined eligible, a GCCF claims reviewer used a standardized

calculator to determine the claimant’s losses (claimants would submit

documentation wherever possible to substantiate their claims).

299

During Phase I of

the GCCF’s operations, it paid a minimum of $1,000, even to claimants whose

damages totaled less.

300

The methods by which the GCCF offered compensation evolved as claimants

continued filing. One option included a one-time payment of $5,000 alongside an

agreement to release claims. This “Final Payment” option was rapid, as no damages

were calculated, and little paperwork or evidence was required to be submitted.

301

The GCCF received claims from claimants from all fifty states in the United

States and from forty countries.

293. BDO CONSULTING, INDEPENDENT EVALUATION OF THE GULF COAST CLAIMS

FACILITY: REPORT OF FINDINGS & OBSERVATIONS TO THE U.S. DEPARTMENT OF JUSTICE 11

(2012), https://www.justice.gov/sites/default/files/opa/legacy/2012/06/06/gccf-rpt-find-obs.pdf

[https://perma.cc/UWC3-F6MX ].

294. G

ULF COAST CLAIMS FACILITY, PROTOCOL FOR INTERIM AND FINAL CLAIMS (2011).

295. BDO

CONSULTING, supra note 293, at 12.

296. Id. at 12.

297. GULF COAST CLAIMS FACILITY, supra note 294, at 2–4.

298. Id. at 4.

299. BDO

CONSULTING, supra note 293, at 31.

300. Id. at 32.

301. Id. at 34.

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158 UC IRVINE LAW REVIEW [Vol. 12:111

The GCCF undertook several steps . . . to meet the language needs of

claimants. These included, but were not limited to, staffing of the

GCG-operated call center with persons fluent in Spanish, Vietnamese and

French and creation of a process by which a telephone translation service

would be used for callers who spoke other languages; staffing of certain

site offices with people who were fluent in Spanish, Vietnamese, Laotian,

Khmer, French and Croatian; making all claim forms available in hardcopy

in Spanish, Vietnamese and Khmer; posting all website content in Spanish,

Vietnamese and Khmer; sending all correspondence that did not require

the inclusion of claimant specific claims information in Spanish,

Vietnamese or Khmer for all claimants who had notified the GCCF of a

preference for one of these languages; providing claimants with an

opportunity for a special appointment with a translator present; and

creating an online claims filing process, accessible through the GCCF

website, through which claimants could file claims in Spanish

and Vietnamese.

302

During its eighteen-month existence, the GCCF paid over six billion dollars

to more than 200 thousand individual and business claimants.

303

It is important to acknowledge that what was true of the GCCF will be true of

any system established through the COVAX Facility. The primary concern

regarding the GCCF was error. Upon an independent investigation of the program

by an outside party at the request of the Department of Justice, it was determined

about 10,000 claimants were either negatively affected by error or erroneously

denied compensation.

304

In a broader context, this represented about a five percent

error rate.

The program implemented by the GCCF was designed by policy and activated

upon a disaster. But there are themes and design elements that are applicable to a

global immunization context. The idea of a centralized claims facility for every

person injured by one vaccine would be much simpler than the current system of

relying on governments to establish their own systems and potentially resulting in

inconsistent judgments against the manufacturer or similar claimants. A centralized

system is also efficient. Instead of 192 separate systems, each independently staffed,

one program for the globe would require fewer resources.

A centralized compensation program, financed through international

donations and a relatively modest $0.05 or $0.10 per dose levy, administered by a

third party, and adjudicating claims in a standardized manner would offer rapid

compensation to those harmed as well as confidence for manufacturers.

305

Globalizing the system, instead of programs in a select few countries, would also

302. Id. at 33.

303. Id. at 59.

304. Id. at 67, 70.

305. Vaccine Injury Financial Assistance Programme for COVID-19 Vaccination, S

ING.

MINISTRY OF HEALTH, (Sept. 16, 2021), https://www.moh.gov.sg/covid-19/vaccination/vifap

[https://perma.cc/Z27K-CQWD ].

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 159

enable manufacturers to distribute vaccines to countries where litigation risk is not

effectively calculable.

2. Boeing 737 Max Crash Compensation System

On October 29, 2018, Lion Air flight 610 crashed, killing every person on

board and resulting in 189 deaths.

306

Five months later, on March 10, 2019,

Ethiopian Airlines flight 302 crashed, killing all 157 people on board.

307

In both

catastrophes, the plane that crashed was a Boeing 737 Max, a new and popular

model.

308

Investigations into both crashes, which followed similar stories of

crashing after failing to gain altitude after takeoff, indicated a defect in the plane

which caused the accidents.

309

Boeing was held liable for the deaths of 346 people,

and the Boeing Max was grounded until the defect was cured and a fix was approved

by the U.S. Federal Aviation Administration.

310

The nationalities of the victims from

the two crashes spanned thirty-five different countries, from the United States to

Kenya to China.

311

International aviation accidents are governed by the Montreal Convention.

This international treaty determines which country’s courts may hear lawsuits

regarding the accident and how much the families of victims may be

compensated.

312

Airline accidents such as the 737 Max crashes are relevant to the

construction of a compensation system for vaccine injuries in that what caused the

harm is not relevant. When a plane crashes and all lives on board are lost, there is a

presumption of a causal relationship.

306. Scott Neuman, Indonesia Report: Pilots, Ground Crew Share Blame with Boeing for Lion Air

Crash, NPR (Oct. 25, 2019, 4:41 AM), https://www.npr.org/2019/10/25/773291951/pilots-ground-

crew-share-blame-for-lion-air-737-max-crash-indonesian-report-says [https://perma.cc/DM89-JSMX ].

307. Hadra Ahmed, Norimitsu Onishi, Dionne Searcey & Hannah Beech, Ethiopian Airlines

Plane Is the 2nd Boeing Max 8 to Crash in Months, N.Y.

TIMES (Mar. 10, 2019), https://

www.nytimes.com/2019/03/10/world/africa/ethiopian-airlines-plane-crash.html [https://

perma.cc/S9V2-T3PS ].

308. Avie Schneider, Boeing 737 Max, Involved in 2 Crashes, Is Fastest-Selling Plane in

Company’s History, NPR (Mar. 11, 2019, 1:55 PM), https://www.npr.org/2019/03/11/702211493/

boeing-737-max-involved-in-two-crashes-is-fastest-selling-plane-in-companys-hist [https://perma.cc/

VM6Q-GJWS ].

309. Lion Air JT610 Crash: What the Preliminary Report Tells Us, BBC (Nov. 28, 2018), https:/

/www.bbc.com/news/world-asia-46373125 [ https://perma.cc/YD4L-MP2R ].

310. David Slotnick, The First Boeing 737 Max Crash Was 2 Years Ago Today. Here’s the

Complete History of the Plane That’s Been Grounded Since 2 Crashes Killed 346 People 5 Months Apart,

US. INSIDER (Oct. 29, 2020, 10:55 AM), https://www.businessinsider.com/boeing-737-max-

timeline-history-full-details-2019-9 [ https://perma.cc/V25M-5JKD ].

311. Press Release, Ethiopian Airlines, Accident Bulletin Number 3 (Mar. 10, 2019), https://

corporate.ethiopianairlines.com/Press-release-open-page/accident-bulletin-no.-3-issued-on-march-10

-2019-at-4-59-pm [https://perma.cc/Y3HK-37P5]; see also Sinéad Baker, What We Know About the

Victims of the Lion Air Plane Crash Off Indonesia, Where There Were ‘likely no survivors’, B

US. INSIDER

(Oct. 31, 2018, 7:24 AM), https://www.businessinsider.com/lion-air-plane-crash-victims-indonesia-

2018-10?r=UK [https://perma.cc/F3XJ-D3UY ].

312. Convention for the Unification of Certain Rules for International Carriage by Air, ch. 3,

May 28, 1999, T.I.A.S. No. 13,038 [hereinafter Montreal Convention].

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160 UC IRVINE LAW REVIEW [Vol. 12:111

Under the Montreal Convention, a carrier is liable for up to 100,000 Special

Drawing Rights (a weighted basket of currencies generated by the International

Monetary Fund with implications for a broad range of international organizations

and private parties) or about $140,000. The convention applies to carriers, not

manufacturers.

313

However, if compensation exceeds this amount, a claimant may

recover if they are able to prove another party is at fault and the carrier is not

responsible. This is the only element of causation open to dispute—compensation

above the limit. Even this element is relatively straightforward. In the 737 Max

context, several aviation authorities investigated the crashes to determine fault and

decided definitively that the 737 Max had a design flaw in its sensors.

314

Both Ethiopian Airlines and Lion Airlines paid out their initial compensations

pursuant to the Montreal Convention. The airlines compensated the victims

through their insurance carriers. Their insurers then recovered from Boeing after

the evidence clearly indicated the fault was with the design of the plane.

315

Boeing

is insured in multiple layers, with both self-insurance then a stop-loss policy with

the British insurer Global Aerospace.

316

Claimants then came to Boeing to recover

the rest needed to adequately compensate them for the loss of their family members.

In September 2019, Boeing announced the creation of a fund designed to

compensate families. The fund was capitalized to around fifty million dollars, and

each passenger’s family was paid $144,500.

317

Accepting payment did not foreclose

any litigation rights for the victims.

318

In the Lion Air Crash (189 fatalities), 150

claims were filed in the U.S. District Court for the Northern District of Illinois in

Chicago. Boeing recently announced they settled 171 claims out of the 189 people

on board, including 140 of those claims filed in the Northern District of Illinois.

319

313. How the Montreal Convention Works in Air Crashes, BAUM HEADLUND ARISTEI

& GOLDMAN, https://www.baumhedlundlaw.com/aviation-accident/montreal-convention-air-

crashes/ [ https://perma.cc/QRY5-JDQL ] (last visited July 19, 2021 ).

314. Ainur Rohmah, Ian Duncan, Michael Laris & Shibani Mahtani, Lion Air Crash

Investigators Fault Boeing 737 Max’s Flight-Control System, Regulatory Lapses and Pilot Training, W

ASH.

POST (Oct. 25, 2019, 10:31 AM), https://www.washingtonpost.com/world/asia_pacific/

investigators-fault-boeing-737-maxs-flight-control-system-regulatory-lapses-and-pilot-training-in-lion-

air-crash/2019/10/25/e8143d06-f69c-11e9-b2d2-1f37c9d82dbb_story.html [https://perma.cc/

VZD3-GHWX].

315. Noor Zainab Hussain, Carolyn Cohn & Suzanne Barlyn, Insurers Face Large Claims After

Second Boeing 737 MAX Crash, R

EUTERS (Mar. 11, 2019, 4:51 AM), https://www.reuters.com/article/

us-ethiopia-airplane-insurance/insurers-face-large-claims-after-second-boeing-737-max-crash-idUSK

BN1QS1D8 [https://perma.cc/6N7V-UX2G].

316. Id.

317. David Shepardson, Boeing to Pay 737 Max Victim’s Families $144,500 Each, R

EUTERS

(Sept. 23, 2019, 11:50 AM), https://www.reuters.com/article/us-ethiopia-airplane-victims/boeing-to-

pay-737-max-crash-victims-families-144500-each-idUSKBN1W8288 [https://perma.cc/RE8G-T6BU ].

318. Id.

319. Eric M. Johnson, Boeing Settles Nearly All Lion Air 737 MAX Crash Claims; Filing,

EUTERS ( July 7, 2020, 4:29 PM), https://www.reuters.com/article/us-boeing-737max-settlement/

boeing-settles-nearly-all-lion-air-737-max-crash-claims-filing-idUSKBN24838P [https://perma.cc/

NB2A-M3T9 ].

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2021] PANDEMIC VACCINE PRODUCT LIABILITY 161

Boeing did not publicize payment amounts, but reports suggest approximately $1.2

million per claim.

320

Under the system organized by Boeing, claimants who were unable to afford

litigation either in the United States or in their home countries were able to receive

compensation. The system also managed Boeing’s liability and expected losses.

ONCLUSION

Tremendous strides have been made toward assuring equitable access to

COVID-19 vaccines for low- and lower-middle-income countries. But affordability

ex ante is not enough. Manufacturers will not ship vaccines to countries where

liability looms, and the populations in those countries that are unable or unwilling

to promise indemnity should not go without vaccines and, if they receive them,

should not be left to subsidize herd immunity enjoyed by the world’s uninjured.

This Article has endeavored to address the liability barrier through analysis of

existing and proposed mechanisms including current no-fault systems, the

expansion of current insurance regimes, and the establishment of a centralized

no-fault system centered at the COVAX Facility.

321

Doing so would address the

pandemic threat, ensure that those suffering rare adverse events are not left to

shoulder the costs associated with the massive benefits accrued by everyone else,

and set an important precedent for future global pandemic planning.

320. Id.

321. See Rahim Moloo & Alex Khachaturian, The Compliance with the Law Requirement in

International Investment Law, 34 FORDHAM INT’L L.J. 1473 (2011).

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162 UC IRVINE LAW REVIEW [Vol. 12:111