COVID-19

Will Moody v. NetChoice, LLC End Social Media?

October 27, 2023
Constitutional Law, COVID-19, Elections, First Amendment, Internet, Social Media

Aidan Vogelson, MJLST Staffer

At first, the concept that social media’s days may be numbered seems outlandish. Billions of people utilize social media every day and, historically, social media companies and other internet services have enjoyed virtually unfettered editorial control over how they manage their services. This freedom stems from 47 U.S.C. § 230.[1] § 230 withholds liability for “any action voluntarily taken in good faith to restrict access to or availability of material that the provider or user considers to be obscene, lewd, lascivious, filthy, excessively violent, harassing, or otherwise objectionable, whether or not such material is constitutionally protected…”[2]  In other words, if someone makes an obscene post on Facebook and Facebook removes the post, Facebook cannot be held liable for any violation of protected speech. § 230 has long allowed social media companies to self-regulate by removing posts that violate their terms of service, but on September 29, the Supreme Court granted a writ of certiorari in Moody v. NetChoice, LLC, a case that may fundamentally change how social media companies operate by allowing the government at the state or federal level to regulate around their § 230 protections.

At issue in Moody is whether the methods social media companies use to moderate their content are permissible under the First Amendment and whether social media companies may be classified as common carriers.[3] Common carriers are services which hold themselves open to the public and transport people or goods.[4] While the term “common carrier” once referred only to public transportation services like railroads and airlines, the definition now encompasses communications services such as radio and telephone companies.[5] Common carriers are subjected to greater regulations, including anti-discrimination regulations, due to their market domination of a necessary public service.[6]  For example, given our reliance on airlines and telephone companies in performing necessary services, common carrier regulations ensure that an airline cannot decline to sell tickets to passengers because of their religious beliefs and a cellular network cannot bar service to customers because it disapproves of the content of their phone conversations. If social media companies are held to be common carriers, the federal government and the state governments could impose regulations on what content those companies restrict.

Moody stems from state efforts to do just that. The Florida legislature passed State Bill 7072 to curtail what it saw as social media censorship of conservative voices.[7] The Florida law allows for significant fines against social media companies that demonstrate “unfair censorship” or “deplatform” political candidates, like X (formerly Twitter) did when it removed former President Trump from its platform for falsely claiming that the 2020 election was stolen.[8] Florida is not the only state to pursue a common carrier designation for social media. Texas passed a similar law in 2021 (which is currently enjoined by NetChoice, LLC  v. Paxton and will be addressed alongside Moody) and the attorney general of Ohio has sued Google, seeking for the court to declare that Google is a common carrier to prevent the company from prioritizing its own products in search results.[9] Ohio v. Google LLC is ongoing, and while the judge partially granted Google’s motion to dismiss, he found that Ohio’s claim that Google is a common carrier is cognizable.[10] Given the increasing propensity with which states are attempting to regulate social media, the Supreme Court’s ruling is necessary to settle this vital issue.

Supporters of classifying social media companies as common carriers argue that social media is simply the most recent advancement in communication and should accordingly be designated a common carrier, just as telephone operators and cellular networks are. They explain that designating social media companies as common carriers is actually consistent with the broad protections of § 230, as regulating speech on a social media site regulates the speech of users, not the speech of the company.[11]

However, they ignore that social media companies rely on First Amendment and § 230 protections when they curate the content on their sites. Without the ability to promote or suppress posts and users, these companies would not be able to provide the personalized content that attracts users, and social media would likely become an even greater hotbed of misinformation and hate speech than it already is. The purpose of § 230 is to encourage the development of a thriving online community, which is why Congress chose to shield internet services from liability for content. Treating social media companies as common carriers would stifle that aim.

It is unclear how the Court will rule. In his concurrence in Biden v. Knight First Amend. Inst., Justice Thomas indicated he may be willing to consider social media companies as common carriers.[12] The other justices have yet to write or comment on this issue, but whatever their decision may be, the ramifications of this case will be significant. The conservative politicians behind the Florida and Texas laws have specifically decried what they argue is partisan censorship of conservative views about the Covid-19 pandemic and the 2020 election, yet these very complaints demonstrate the need for social media companies to exercise editorial control over their content. Covid-19 misinformation unquestionably led to unnecessary deaths from the Covid-19 pandemic.[13] Misinformation about the 2020 election led to a violent attempted overthrow of our government. These threats of violence and dangerous misinformation are the harms that Congress created § 230 to avoid. Without the ability for social media companies to curate content, social media will assuredly contain more racism, misinformation, and calls for violence. Few would argue given the omnipresence of social media in our modern world, our reliance on it for communication, and the misinformation it spreads that social media does not need some form of regulation, but if the Court allows the Florida and Texas laws implicated in Moody and NetChoice to stand, they will be paving the way for a patchwork quilt of laws in every state which may render social media unworkable

Notes

[1] See 47 U.S.C. § 230.

[2] 47 U.S.C. §230(c)(2)(A).

[3] Moody v. Netchoice, LLC, SCOTUSblog, https://www.scotusblog.com/case-files/cases/moody-v-netchoice-llc/.

[4] Alison Frankel, Are Internet Companies ‘Common Carriers’ of Content? Courts Diverge on Key Question, REUTERS, (May 31, 2022, 5:52 PM), https://www.reuters.com/legal/transactional/are-internet-companies-common-carriers-content-courts-diverge-key-question-2022-05-31/.

[5] Id.

[6] Id.

[7] David Savage, Supreme Court Will Decide if Texas and Florida Can Regulate Social Media to Protect ‘Conservative Speech’, LA TIMES (Sept. 29, 2023, 8:33 AM), https://www.msn.com/en-us/news/us/supreme-court-will-decide-if-texas-and-florida-can-regulate-social-media-to-protect-conservative-speech/ar-AA1hrE2s.

[8] Id.

[9] AG Yost Files Landmark Lawsuit to Declare Google a Public Utility, OHIO ATTORNEY GENERAL’S OFFICE (June 8, 2021), https://www.ohioattorneygeneral.gov/Media/News-Releases/June-2021/AG-Yost-Files-Landmark-Lawsuit-to-Declare-Google-a.

[10] Ohio v. Google LLC, No. 21-CV-H-06-0274 (Ohio Misc. 2022), https://fingfx.thomsonreuters.com/gfx/legaldocs/gdpzyeakzvw/frankel-socialmediacommoncarrier–ohioruling.pdf.

[11] John Villasenor, Social Media Companies and Common Carrier Status: A Primer, BROOKINGS INST. (Oct. 27, 2022), https://www.brookings.edu/articles/social-media-companies-and-common-carrier-status-a-primer/.

[12] Biden v. Knight First Amend. Inst., 141 S. Ct. 1220 (2021),  https://www.law.cornell.edu/supremecourt/text/20-197.

[13] Alistair Coleman, ’Hundreds Dead’ Because of Covid-19 Misinformation, BBC (Aug. 12, 2020), https://www.bbc.com/news/world-53755067.

The Policy Future for Telehealth After the Pandemic

April 14, 2023
COVID-19, Cyber Security, Data Privacy, Health, Healthcare, Healthcare Reform, Public Health

Jack Atterberry, MJLST Staffer

The Pandemic Accelerated Telehealth Utilization

Before the Covid-19 pandemic began, telehealth usage in the United States healthcare system was insignificant (rounding to 0%) as a percentage of total outpatient care visits.[1] In the two years after the beginning of the pandemic, telehealth usage soared to over 10% of outpatient visits and has been widely used across all payer categories including Medicare and Medicaid.[2] The social distancing realities during the pandemic years coupled with federal policy measures allowed for this radical transition toward telehealth care visits.

In response to the onset of Covid-19, the US federal government relaxed and modified many telehealth regulations which have expanded the permissible access of telehealth care services. After a public health emergency was declared in early 2020, the Center for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) modified preexisting telehealth-related regulations to expand the permissible use of those services.  Specifically, CMS temporarily expanded Medicare coverage to include telehealth services without the need for in-person visits, removed telehealth practice restrictions such as expanding the type of providers that could provide telehealth, and increased the reimbursement rates for telehealth services to bring them closer to in-person visit rates.[3] In addition, HHS implemented modifications such as greater HIPAA flexibility by easing requirements around using popular communication platforms such as Zoom, Skype, and FaceTime provided that they are used in good faith.[4]  Collectively, these changes helped lead to a significant rise in telehealth services and expanded access to care for many people that otherwise would not receive healthcare.  Unfortunately, many of these telehealth policy provisions are set to expire in 2024, leaving open the question of whether the benefits of telehealth care expansion will be here to stay after the public emergency measures end.[5]

Issues with Telehealth Care Delivery Between States

A big legal impediment to telehealth expansion in the US is the complex interplay of state and federal laws and regulations impacting telehealth care delivery. At the state level, key state differences in the following areas have historically held back the expansion of telehealth.  First, licensing and credentialing requirements for healthcare providers are most often licensed at the state level – this has created a barrier for providers who want to offer telehealth services across state lines. While many states have implemented temporary waivers or joined interstate medical licensure compacts to address this issue during the pandemic, many states have not done so and huge inconsistencies exist. Besides these issues, states also differ with regard to reimbursement policy as states differ significantly in how different payer types insure differently in different regions—this has led to confusion for providers about whether to deliver care in certain states for fear of not getting reimbursed adequately. Although the federal health emergency helped ease interstate telehealth restrictions since the pandemic started, these challenges will likely persist after the temporary telehealth measures are lifted at the end of 2024.

What the pandemic-era temporary easing of telehealth restrictions taught us is that interstate telehealth improves health outcomes, increases patient satisfaction, and decreases gaps in care delivery.  In particular, rural communities and other underserved areas with relatively fewer healthcare providers benefited greatly from the ability to receive care from an out of state provider.  For example, patients in states like Montana, North Dakota, and South Dakota benefit immensely from being able to talk with an out of state mental health provider because of the severe shortages of psychiatrists, psychologists, and other mental health practitioners in those states.[6]  In addition, a 2021 study by the Bipartisan Policy Center highlighted that patients in states which joined interstate licensure compacts experienced a noticeable improvement in care experience and healthcare workforces experienced a decreased burden on their chronically stressed providers.[7]  These positive outcomes resulting from eased interstate healthcare regulations should inform telehealth policy moving forward.

Policy Bottlenecks to Telehealth Care Access Expansion

The presence of telehealth in American healthcare is surprisingly uncertain as the US emerges from the pandemic years.  As the public health emergency measures which removed various legal and regulatory barriers to accessing telehealth expire next year, many Americans could be left without access to healthcare via telehealth services. To ensure that telehealth remains a part of American healthcare moving forward, federal and state policy makers will need to act to bring about long term certainty in the telehealth regulatory framework.  In particular, advocacy groups such as the American Telehealth Association recommend that policy makers focus on key policy changes such as removing licensing barriers to interstate telehealth care, modernizing reimbursement payment structures to align with value-based payment principles, and permanently adopting pandemic-era telehealth access for Medicare, Federally Qualified Health Centers, and Rural Health Clinics.[8]  In addition, another valuable federal regulatory policy change would be to continue allowing the prescription of controlled substances without an in-person visit.  This would entail modifying the Ryan Haight Act, which requires an in-person medical exam before prescribing controlled substances.[9]  Like any healthcare reform in the US, cementing these lasting telehealth policy changes as law will be a major uphill battle.  Nonetheless, expanding access to telehealth could be a bipartisan policy opportunity for lawmakers as it would bring about expanded access to care and help drive the transition toward value-based care leading to better health outcomes for patients.

Notes

[1] https://www.healthsystemtracker.org/brief/outpatient-telehealth-use-soared-early-in-the-covid-19-pandemic-but-has-since-receded/

[2] https://www.cms.gov/newsroom/press-releases/new-hhs-study-shows-63-fold-increase-medicare-telehealth-utilization-during-pandemic#:~:text=Taken%20as%20a%20whole%2C%20the,Island%2C%20New%20Hampshire%20and%20Connecticut.

[3] https://telehealth.hhs.gov/providers/policy-changes-during-the-covid-19-public-health-emergency

[4] Id.

[5] https://hbr.org/2023/01/its-time-to-cement-telehealths-place-in-u-s-health-care

[6] https://thinkbiggerdogood.org/enhancing-the-capacity-of-the-mental-health-and-addiction-workforce-a-framework/?_cldee=anVsaWFkaGFycmlzQGdtYWlsLmNvbQ%3d%3d&recipientid=contact-ddf72678e25aeb11988700155d3b3c69-e949ac3beff94a799393fb4e9bbe3757&utm_source=ClickDimensions&utm_medium=email&utm_campaign=Health%20%7C%20Mental%20Health%20Access%20%7C%2010.19.21&esid=e4588cef-7520-ec11-b6e6-002248246368

[7] https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2021/11/BPC-Health-Licensure-Brief_WEB.pdf

[8] https://hbr.org/2023/01/its-time-to-cement-telehealths-place-in-u-s-health-care

[9] https://www.aafp.org/pubs/fpm/issues/2021/0500/p9.html

Mental Health Telehealth Services May Not Be Protecting Your Data

March 5, 2023
Administrative Law, COVID-19, Data Privacy, Health, Healthcare, Internet, New Technology, Privacy

Tessa Wright, MJLST Staffer

The COVID-19 pandemic changed much about our daily lives, and nowhere have those changes been more visible than in the healthcare industry. During the pandemic, there were overflowing emergency rooms coupled with doctor shortages.[1] In-person medical appointments were canceled, and non-emergency patients had to wait months for appointments.[2] In response, the use of telehealth services began to increase rapidly.[3] In fact, one 2020 study found that telehealth visits accounted for less than 1% of health visits prior to the pandemic and increased to as much as 80% of visits when the pandemic was at its peak.[4] And, while the use of telehealth services has decreased slightly in recent years, it seems as though it is likely here to stay. Nowhere has the use of telehealth services been more prevalent than in mental health services.[5] Indeed, as of 2022, telehealth still represented over 36% of outpatient mental health visits.[6] Moreover, a recent study found that since 2020, over one in three mental health outpatient visits have been delivered by telehealth.[7] And while this increased use in telehealth services has helped make mental health services more affordable and accessible to many Americans, this shift in the way healthcare is provided also comes with new legal concerns that have yet to be fully addressed.

Privacy Concerns for Healthcare Providers

One of the largest concerns surrounding the increased use of telehealth in mental health services is privacy. There are several reasons for this. The primary concern has been due to the fact that telehealth takes place over the phone or via personal computers. When using personal devices, it is nearly impossible to ensure HIPAA compliance. However, the majority of healthcare providers now offer telehealth options that connect directly to their private healthcare systems, which allows for more secure data transmission.[8] While there are still concerns surrounding this issue, these secure servers have helped mitigate much of the concern.[9]

Privacy Concerns with Mental Health Apps

The other privacy concern surrounding the use of telehealth services for mental health is a little more difficult to address. This concern comes from the increased use of mental health apps. Mental health apps are mobile apps that allow users to access online talk therapy and psychiatric care.[10] With the increased use of telehealth for mental health services, there has also been an increase in the use of these mental health apps. Americans are used to their private medical information being protected by the Health Insurance Portability and Accountability Act (HIPAA).[11] HIPAA is a federal law that creates privacy rules for our medical records and other individually identifiable health information during the flow of certain health care transactions.[12] But HIPAA wasn’t designed to handle modern technology.[13] The majority of mental health apps are not covered by HIPAA rules, meaning that these tech companies can sell the private health data from their apps to third parties, with or without consent.[14] In fact, a recent study that analyzed 578 mental health-related apps found that nearly half (44%) of the apps shared users’ personal health information with third parties.[15] This personal health information can include psychiatric diagnoses and medication prescriptions, as well as other identifiers including age, gender, ethnicity, religion, credit score, etc.[16]

In fact, according to a 2022 study, a popular therapy app, BetterHelp, was among the worst offenders in terms of privacy.[17] “BetterHelp has been caught in various controversies, including a ‘bait and switch’ scam where it advertised therapists that weren’t actually on its service, poor quality of care (including trying to provide gay clients with conversion therapy), and paying YouTube influencers if their fans sign up for therapy through the app.”[18]

An example of information that does get shared is the intake questionnaire.[19] An intake questionnaire needs to be filled out on BetterHelp, or other therapy apps, in order for the customer to be matched with a provider.[20] The answers to these intake questionnaires were specifically found to have been shared by BetterHelp with an analytics company, along with the approximate location and device of the user.[21]

Another example of the type of data that is shared is metadata.[22] BetterHelp can share information about how long someone uses the app, how long the therapy sessions are, how long someone spends sending messages on the app, what times someone logs into the app, what times someone sends a message or speaks to their therapists, the approximate location of the user, how often someone opens the app, and so on.[23] According to the ACLU, data brokers, Facebook, and Google were found to be among the recipients of other information shared from BetterHelp.[24]

It is also important to note that deleting an account may not remove all of your personal information, and there is no way of knowing what data will remain.[25] It remains unclear how long sensitive information that has been collected and retained could be available for use by the app.

What Solutions Are There?

The U.S. Department of Health and Human Services recently released updated guidance on HIPAA, confirming that the HIPAA Privacy Rule does not apply to most health apps because they are not “covered entities” under the law.[26]  Additionally, the FDA put out guidance saying that it is going to use its enforcement discretion when dealing with mental health apps.[27] This means that if the privacy risk seems to be low, the FDA is not going to enforce or chase these companies.[28]

Ultimately, if mental telehealth services are here to stay, HIPAA will need to be expanded to cover the currently unregulated field of mental health apps. HIPAA and state laws would need to be specifically amended to include digital app-based platforms as covered entities.[29] These mental health apps are offering telehealth services, similar to any healthcare provider that is covered by HIPAA. Knowledge that personal data is being shared so freely by mental health apps often leads to distrust, and due to those privacy concerns, many users have lost confidence in them. In the long run, regulatory oversight would increase the pressure on these companies to show that their service can be trusted, potentially increasing their success by growing their trust with the public as well.

Notes

[1] Gary Drenik, The Future of Telehealth in a Post-Pandemic World, Forbes, (Jun. 2, 2022), https://www.forbes.com/sites/garydrenik/2022/06/02/the-future-of-telehealth-in-a-post-pandemic-world/?sh=2ce7200526e1.

[2] Id.

[3] Id.

[4] Madjid Karimi, et. al., National Survey Trends in Telehealth Use in 2021: Disparities in Utilization and Audio vs. Video Services, Office of Health Policy (Feb. 1, 2022).

[5] Shreya Tewari, How to Navigate Mental Health Apps that May Share Your Data, ACLU (Sep. 28, 2022).

[6] Justin Lo, et. al., Telehealth has Played an Outsized Role Meeting Mental Health Needs During the Covid-19 Pandemic, Kaiser Family Foundation, (Mar. 15, 2022), https://www.kff.org/coronavirus-covid-19/issue-brief/telehealth-has-played-an-outsized-role-meeting-mental-health-needs-during-the-covid-19-pandemic/.

[7] Id.

[8] Supra note 1.

[9] Id.

[10] Heather Landi, With Consumers’ Health and Privacy on the Line, do Mental Wellness Apps Need More Oversight?, Fierce Healthcare, (Apr. 21, 2021), https://www.fiercehealthcare.com/tech/consumers-health-and-privacy-line-does-digital-mental-health-market-need-more-oversight.

[11] Peter Simons, Your Mental Health Information is for Sale, Mad in America, (Feb. 20, 2023), https://www.madinamerica.com/2023/02/mental-health-information-for-sale/.

[12] Supra note 5.

[13] Supra note 11.

[14] Id.

[15] Deb Gordon, Using a Mental Health App? New Study Says Your Data May Be Shared, Forbes, (Dec. 29, 2022), https://www.forbes.com/sites/debgordon/2022/12/29/using-a-mental-health-app-new-study-says-your-data-may-be-shared/?sh=fe47a5fcad2b.

[16] Id.

[17] Supra note 11.

[18] Id.

[19] Supra note 5.

[20] Id.

[21] Id.

[22] Id.

[23] Id.

[24] Id.

[25] Supra note 5.

[26] Id.

[27] Supra note 10.

[28] Id.

[29] Supra note 11.

Digital Literacy, a Problem for Americans of All Ages and Experiences

May 10, 2022
COVID-19, Cryptocurrency, Cyber Security, Data, Education, Ethics, Human Behavior, Internet

Justice Shannon, MJLST Staffer

According to the American Library Association, “digital literacy” is “the ability to use information and communication technologies to find, evaluate, create, and communicate information, requiring both cognitive and technical skills.” Digital literacy is a term that has existed since the year 1997. Paul Gilster coined Digital literacy as “the ability to understand and use information in multiple formats from a wide range of sources when it is presented via computers.” In this way, the definition of digital literacy has broadened from how a person absorbs digital information to how one develops, absorbs, and critiques digital information.

The Covid-19 Pandemic taught Americans of all ages the value of Digital literacy. Elderly populations were forced online without prior training due to the health risks presented by Covid-19, and digitally illiterate parents were unable to help their children with classes.

Separate from Covid-19, the rise of crypto-currency has created a need for digital literacy in spaces that are not federally regulated.

Elderly

The Covid-19 pandemic did not create the need for digital literacy training for the elderly. However, the pandemic highlighted a national need to address digital literacy among America’s oldest population. Elderly family members quarantined during the pandemic were quickly separated from their families. Teaching family members how to use Zoom and Facebook messenger became a substitute for some but not all forms of connectivity. However, teaching an elderly family member how to use Facebook messenger to speak to loved ones does not enable them to communicate with peers or teach them other digital literacy skills.

To address digital literacy issues within the elderly population states have approved Senior Citizen Technology grants. Pennsylvania’s Department of Aging has granted funds to adult education centers for technology for senior citizens. Programs like this have been developing throughout the nation. For example, Prince George’s Community College in Maryland uses state funds to teach technology skills to its older population.

It is difficult to tell if these programs are working. States like Pennsylvania and Maryland had programs before the pandemic. Still, these programs alone did not reduce the distance between America’s aging population and the rest of the nation during the pandemic. However, when looking at the scale of the program in Prince George’s County, this likely was not the goal. Beyond that, there is a larger question: Is the purpose of digital literacy for the elderly to ensure that they can connect with the world during a pandemic, or is the goal simply ensuring that the elderly have the skills to communicate with the world? With this in mind, programs that predate the pandemic, such as the programs in Pennsylvania and Maryland, likely had the right approach even if they weren’t of a large enough scale to ensure digital literacy for the entirety of our elderly population.

Parents

The pandemic highlighted a similar problem for many American families. While state, federal, and local governments stepped up to provide laptops and access to the internet, many families still struggled to get their children into online classes; this is an issue in what is known as “last mile infrastructure.”During the pandemic, the nation quickly provided families with access to the internet without ensuring they were ready to navigate it. This left families feeling ill-prepared to support their children’s educational growth from home. Providing families with access to broadband without digital literacy training disproportionately impacted families of color by limiting their children’s growth capacity online compared to their peers. While this wasn’t an intended result, it is a result of hasty bureaucracy in response to a national emergency. Nationally, the 2022 Workforce Innovation Opportunity Act aims to address digital literacy issues among adults by increasing funding for teaching workplace technology skills to working adults. However, this will not ensure that American parents can manage their children’s technological needs.

Crypto

Separate from issues created by Covid-19 is cryptocurrency. One of the largest selling points of cryptocurrency is that it is largely unregulated. Users see it as “digital gold, free from hyper-inflation.”While these claims can be valid, consumers frequently are not aware of the risks of cryptocurrency. Last year the Chair of the SEC called cryptocurrencies “the wild west of finance rife with fraud, scams, and abuse.”This year the Department of the Treasury announced they would release instructional materials to explain how cryptocurrencies work. While this will not directly regulate cryptocurrencies providing Americans with more tools to understand cryptocurrencies may help reduce cryptocurrency scams.

Conclusion

Addressing digital literacy has been a problem for years before the Covid-19 pandemic. Additionally, when new technologies become popular, there are new lessons to learn for all age groups. Covid-19 appropriately shined a light on the need to address digital literacy issues within our borders. However, if we only go so far as to get Americans networked and prepared for the next national emergency, we’ll find that there are disparities between those who excel online and those who are are ill-equipped to use the internet to connect with family, educate their kids, and participate in e-commerce.

Who Has to Pay? Major Contractual Elements That Affect Which Party Bears the Cost of Supply Chain Delays and Price Increases in Construction Projects

April 17, 2022
Business Law, Contract Law, COVID-19, Supply Chain

Kristin Thompson, MJLST Staffer

As a result of the COVID-19 pandemic there have been supply chain issues occurring around the world, causing constant price increases and delivery delays for construction materials.[1] While there are numerous factors that will affect exactly where the expenses of those delays fall, this article briefly outlines the major contractual elements that will come into play when determining whether the contractor, subcontractor or owner bears the risk. The first question that should be asked when investigating COVID-19 related supply chain issues is, “what does the contract say?” However, my first area of analysis begins when the answer to that question is “we don’t have one yet.”

 

The contract is not yet executed

This is the first major element to be addressed: what point of the contractual process the parties are in. To be clear, once the contract and subcontracts are executed the parties must rely on contract remedies and their pricing structures for relief. However, if the contracts have not yet been executed the contractor and subcontractors still have the potential to push the risk onto the owner or devise an equitable way to share those risks. They can build the supply chain-related price increases and project delay costs into their estimates, putting the owner in the position to either accept the increased cost and timeline or forego the project. During this pre-execution process the contractors will largely either be bidding a cost plus guaranteed maximum price model (“GMP”) or a lump sum model.[2] Here the GMP is ideal as the contractor can build the increased costs into the contingency. The lump sum model will call for an upward adjustment to their estimated total costs to account for the increases, chancing that those estimates will be enough. After adjusting their price model, the contractor and subcontractors can then add contractual language specifically saying that they are allowed time extensions for any and all supply chain delays, define their force majeure clause as inclusive of a pandemic or epidemic, and include change in law provisions that cover mandates issued as a result of the COVID-19 pandemic.

 

The Contract is Executed

In this case, the parties will need to dive into their contract to see who bears the responsibility for extra costs and find out if they are able to extend their timelines without consequence. Issues relating to extra costs will be almost exclusively determined by whether or not a GMP or lump sum price model was used. Absent provisions stating otherwise, a GMP will allocate the extra costs to the owner up to the guaranteed maximum price as those costs come out of the contingency fee, while a lump sum contract will allocate them to the contractor as the costs will come out of the total bid price.[3] In the latter scenario, the contractor can then hold subcontractors to the price of their contract and make them bear their own price increases which would relieve the contractor from some of the extra cost burden. However, the contractor must keep in mind the reality in which a subcontractor would not be able to bear the extra costs and then either go out of business or refuse to perform. Legal action taken will either be futile if the subcontractor is insolvent, or expensive and time-consuming if they refuse to perform.

The parties then must determine whether or not schedule extensions resulting from supply chain issues are proper. This determination will largely be based on the force majeure clause and change in law provision located in the general conditions.

 

Force Majeure Clause

If the COVID-19 pandemic is found to be included as a force majeure event, the contractor will be allowed a time extension for the extra work relating thereto. Some contracts pre-dating the pandemic already used language relating to a pandemic or epidemic. The most regularly used form contracts, 200AIA.201-017[4] and ConsensusDocs 200[5],include broad force majeure provisions that have been read to include the pandemic.[6] The AIA provides for “other causes beyond contractors control,[7]” and the ConsensusDocs200 for “any cause beyond the control of constructor” and “epidemics.[8]” The specific delays must still be attributed to the pandemic, and proving causation will depend on the amount of proof the suppliers can provide to support that claim. The more challenging situations are those in which the contracts have narrow force majeure clauses or contain catch-all phrases.[9] Interpretation in these cases tend to be dependent on state law and vary widely.[10] If found to not include the pandemic, the contractor will not be guaranteed a time extension for delays and will be held to their original timeline absent other contractual provisions affording them an extension.

 

Changes in Law Provision

The final factor is whether the contract has a change of law provision. If so, executive orders or other changes of law related to the pandemic may allow for time extensions.[11] For instance, a delay in production because a factory producing specified windows had to cut their work force in half to stay in line with federal social distancing mandates would constitute a change in law allowing the contractor an extension while they wait for the windows. ConsensusDOCS 200 currently provides that “the contract price or contract time shall be equitably adjusted by change order for additional costs resulting from any changes in laws…[12]” thus laying out an avenue for relief for those party to a ConsensusDOCS 200 contract. Conversely, the AIA.201-2017 currently does not provide a change in law provision, taking away this option for the large number of contractors that use this form.

In sum, when viewing supply chain delays and expenses in an attempt to ascertain who bears the risk one should look to where the parties are at in their contractual process, the price model being used, the general conditions involved and the breadth of the force majeure and change in law provisions.

 

Notes

[1] Continued Increases In Construction Materials Prices Starting To Drive Up Price Of Construction Projects, As Supply-chain & Labor Woes Continue, The Associated General Contractors of America (November 9, 2021).

[2] Richard S. Reizen, Philip P. Piecuch, & Daniel E. Crowley, Practice Note, Construction Pricing Models – Choosing an Appropriate Pricing Arrangement, Gould + Ratner (2018).

[3] Joseph Clancy, How Do Guaranteed Maximum Price (GMP) Contracts Work?, Oracle (May 20, 2021).

[4] AIA Document 201-2017.

[5] ConsensusDOCS 200.

[6] Force Majeure Provisions: COVID-19, Sheet Metal and Air Conditioning Contractors’ National Association (June 3, 2021).

[7] AIA Document 201-2017 § 8.3.1.

[8] ConsensusDOCS 200 § 6.3.1.

[9] Douglas V. Bartman, Force Majeure in Construction and Real Estate Claims, American Bar Association (July 17, 2020).

[10] Id.

[11] Peter Hahn, Enough About Force Majeure! What Other Options Does a Construction Contractor Have for COVID-19 Pandemic Losses?, JDSupra (April 3, 2020).

[12] ConsensusDOCS 200 § 3.21.1

I’ve Been Shot! Give Me a Donut!: Linking Vaccine Verification Apps to Existing State Immunization Registries

April 18, 2021
COVID-19, Data Privacy, Healthcare, Human Rights Law, Public Health

Ian Colby, MJLST Staffer

The gold rush for vaccination appointments is in full swing. After Governor Walz and many other governors announced an acceleration of vaccine eligibility in their states, the newly eligible desperately sought vaccinations to help the world achieve herd immunity to the SARS-CoV-2 virus (“COVID”) and get back to normal life.

The organization administering a person’s initial dose typically gives the recipient an approximately 4” x 3” card that provides the vaccine manufacturer, the date and location of inoculation, and the Centers for Disease Control (“CDC”) logo. The CDC website does not specify what, exactly, this card is for. Likely reasons include informing the patient about the healthcare they just received, a reminder card for a second dose, or providing batch numbers in case a manufacturing issue arises. Maybe they did it for the ‘Gram. However, regardless of the CDC’s reason for the card, many news outlets have latched onto the most likely future use for them: as a passport to get the post-pandemic party started.

Airlines, sports venues, schools, and donut shops are desperate to return to safe mass gatherings and close contact, without needing to enforce as many protective measures. These organizations, in the short-term, will likely seek assurance of a person’s vaccination status. Aside from the equitable and scientific issues with requiring this assurance, these business will likely get “proof” with these CDC vaccination cards. The cardboard and ink security of these cards rivals social security cards in the “high importance – zero protection” category. Warnings of scammers providing blank CDC cards or stealing the vaccinated person’s name and birthdate hit the web last week (No scammers needed: you can get Missouri’s PDF to print one for free).

With so little security, but with a business-need to reopen the economy to vaccinated folks, businesses and governments have turned to digital vaccine passports. Generically named “digital health passes,” these apps will allow a person to show proof of their vaccination status securely. They “provide a path to reviving the economy and getting Americans back to work and play” according to a New York Times article. “For any such certificate or passport to work, it is going to need two things – access to a country’s official records of vaccinations and a secure method of identifying an individual and linking them to their health record.”

A variety of sources have undertaken development of these digital health passes, both governments and private firms. Israel already provides a nationwide digital proof of vaccination known as a Green Pass. Denmark followed suit with the Coronapas. In addition, a number of private companies and nonprofits are vying to become the preeminent vaccine status app for the world’s smartphones. While governments, such as Israel, have preexisting authority to access immunization and identification records, private firms do not. Private firms would require authorization to access your medical records.

So, in the United States, who would run these apps? Not the U.S. federal government. The Biden Administration unequivocally denied that it would ever require vaccine status checks, and would not keep a vaccination database. The federal government does not need to, though. Most states already manage a digital vaccination database, pursuant to laws authorizing them. Every other state, which doesn’t directly authorize them, still maintains a digital database anyway. These immunization information systems (“IIS”) provide quick access to a person’s vaccination status. A state’s resident can make a request for their vaccination status on myriad vaccinations for free and receive the results via email. Texas and Florida, who made big hubbubs about restricting any use of vaccine passports, both have registries to provide proof of vaccination. So does New York, who has already published an app, known as the Excelsior Pass, that does this for the COVID vaccine. The State’s app pulls information from New York’s immunization registry, providing a quick, simple yes-no result for those requiring proof. The app uses IBM’s blockchain technology, which is “designed to enable the secure verification of health credentials such as test results and vaccination records without the need to share underlying medical and personal information.”

With so many options, consumers of vaccine status apps could become overwhelmed. A vaccinated person may need to download innumerable apps to enter myriad activities. “Fake” apps could ask for additional medical information from the unwary. Private app developers may try to justify continued use of the app after the need for COVID vaccination proof passes.

In this competitive atmosphere, apps that partner with state governments likely provide the best form of digital vaccination verification. These apps have direct approval from the states that are required by law to maintain these vaccination records. They provide some authority to avoid scams. And cooperation to achieve state standardization of these apps may facilitate greater use. States seeking to reopen their economies should authorize digital interfaces with their pre-existing immunization registries. Now that the gold rush for vaccinations has started, the gold rush for vaccine passports is something to keep an eye on.

 

No, Dolphins Did Not Reappear in Venice Canals: The Effects of COVID-19 on the Environment

March 14, 2021
COVID-19, Environment, Public Health

Drew Miller, MJLST Staffer

2020 was a strange, difficult year for billions of people as the COVID-19 pandemic wreaked havoc across the globe. The virus has claimed the lives of over 2,500,000 people, but the effects of the pandemic extend well beyond the loss of life. In an effort to slow the spread of the virus, governments at every level around the world began to implement protective measures such as stay-at-home orders and travel bans as early as March 2020 in the United States—nearly a full year ago. The mass quarantine forced over 100,000 businesses to close their doors in the first two months—some temporarily, some permanently— which in turn led to a rise in unemployment and massive drops in stock markets such as the Dow Jones and the FTSE. These economic effects and their potential remedies have been debated endlessly by news organizations, politicians, and regular citizens alike. However, the environmental effects of the pandemic have not been covered as extensively. Reduced travel tendencies have provided the climate and environment a reprieve, but it will not last; if we are to continue down the road towards environmental sustainability, we must continue to push for reform despite the unique challenges presented by COVID-19.

Environmental Effects

In mid-March, 2020, scattered among an unremitting flood of bad news, some happy stories emerged. Swans and dolphins had returned to formerly desolate Venice canals. A group of elephants had sauntered through a village in Yunnan, China, gotten drunk off corn wine, and passed out in a tea garden. Wild boars were wandering through towns. The stories continued. These reports of the Earth healing and wildlife reclaiming space in a world without people went viral, and understandably so: they offered a spark of light in a dark and uncertain time. One tweet (since deleted) about fish, swans, and clear water in Venice canals amassed over 1,000,000 likes.

Unfortunately, the stories weren’t real. “The swans … regularly appear in the canals of Burano.” “The ‘Venetian’ dolphins were filmed at a port in Sardinia, in the Mediterranean Sea, hundreds of miles away.” The water was clearer because fewer boats were disturbing the sediment at the bottom. The elephants are a regular presence in the depicted village. If anything, allow these stories to serve as a reminder not to believe everything on the internet.

Moreover, the pandemic may have hurt wildlife more than it helped. Many governments pay for environmental conservation and enforcement initiatives with tourism revenue. As that revenue dried up and budgets were cut, those protections weakened. Financial distress caused by widespread unemployment further exacerbated the situation. In April, there were reports of increased falcon smuggling in Pakistan; in June, poaching of leopards and tigers in India; and in October, trafficking of rhino horns in South Africa and Botswana. The chaos of the pandemic also provided cover for illegal logging in the Brazilian Amazon rainforest, which rose more than 50% in the first three months of 2020 compared to the same period in 2019.

Nevertheless, despite the absence of Venetian dolphins, the pandemic looked “okay” from an environmental perspective in 2020. Although there was an uptick in reliance on single-use plastics during lockdowns and increased generation of biomedical waste, pollution levels improved. Transportation, the most significant source of greenhouse gases in the United States, saw a 14.7% decline in emissions, and America’s greenhouse gas emissions from energy and industry plummeted more than 10 percent in 2020, reaching their lowest levels in at least three decades. According to a research group, the fall in emissions nationwide was the largest one-year decline since at least World War II. There were also reduced levels of water and noise pollution.

Policy Implications

Unfortunately, the pollution-related benefits of COVID-19 are likely only temporary. Emissions reductions and air quality improvements primarily resulted from reduced transportation. Consequently, as more people return to their typical travel habits, emissions and air quality are likely to bounce back to their pre-pandemic levels. As Corinne Le Quere, professor of climate change at the University of East Anglia in Britain, stated, “We still have the same cars, the same roads, the same industries, same houses. So as soon as the restrictions are released, we go right back to where we were.”

In fact, emissions may bounce back to levels even higher than they were prior to the pandemic due to the dismantling of numerous climate and environmental policies worldwide. In the United States, nearly 100 environmental protection policies and regulations were reversed or rolled back during the Trump presidency. Citing economic concerns due to COVID, the Czech Prime Minister urged the European Union to abandon the Green New Deal and the European Automobile Manufacturers Association lobbied the European Commission to weaken vehicle emission standards.

COVID-19 has impacted just about every industry in the world, and its economic ramifications continue to present significant difficulties. However, the pandemic is, ultimately, temporary; rebuilding will be challenging, but just as the economy rebounded after the 2008 recession, so it will do again. The Earth may not be so resilient. If we are to achieve a healthier and more sustainable world, businesses and policymakers alike must not recoil from that effort even in the face of unexpected bumps in the road—instead, they must forge ahead.

Intellectual Property in Crisis: Does SARS-CoV-2 Warrant Waiving TRIPS?

February 21, 2021
Bioethics, Biotechnology, COVID-19, Food and Drug Law, Health, Healthcare, Intellectual Property, Patents, Regulatory

Daniel Walsh, MJLST Staffer

The SARS-CoV-2 virus (which causes the disease COVID-19) has been a massive challenge to public health causing untold human suffering. Multiple vaccines and biotechnologies have been developed to combat the virus at a record pace, enabled by innovations in biotechnology. These technologies, vaccines in particular, represent the clearest path towards ending the pandemic. Governments have invested heavily in vaccine development. In May 2020 the United States made commitments to purchase, at the time, untested vaccines. These commitments were intended to indemnify the manufacture of vaccines allowing manufacturing to begin before regulatory approval was received from the Food and Drug Administration. The United States was not alone. China and Germany, just to name two, contributed heavily to funding the development of biotechnology in response to the pandemic. It is clear that both private and public institutions contributed heavily to the speed with which biotechnology has been developed in the context of the SARS-CoV-2 pandemic. However, there are criticisms that the public-private partnerships underlying vaccine manufacturing and distribution have been opaque. The contracts between governments and manufacturers are highly secretive, and contain clauses that disadvantage the developing world, for example forbidding the donation of extra vaccine doses.

Advanced biotechnology necessarily implicates intellectual property (IP) protections. Patents are the clearest example of this. Patents protect what is colloquially thought of as inventions or technological innovations. However, other forms of IP also have their place. Computer code, for example, can be subject to copyright protection. A therapy’s brand name might be subject to a trademark. Trade secrets can be used to protect things like clinical trial data needed for regulatory approval. IP involved in the pandemic is not limited to technologies developed directly in response to the emergence of SARS-CoV-2. Moderna, for example, has a variety of patents filed prior to the pandemic that protect its SARS-CoV-2 vaccine. IP necessarily restricts access, however, and in the context of the pandemic this has garnered significant criticism. Critics have argued that IP protections should be suspended or relaxed to expand access to lifesaving biotechnology. The current iteration of this debate is not unique; there is a perennial debate about whether it should be possible to obtain IP which could restrict access to medical therapies. Many nations have exceptions that limit IP rights for things like medical procedures. See, e.g., 35 U.S.C. 287(c).

In response to these concerns the waiver of a variety of IP protections has been proposed at the World Trade Organization (WTO). In October 2020 India and South Africa filed a communication proposing “a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.” The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) sets minimum standards for IP standards, acquisition, and enforcement and creates an intergovernmental dispute resolution process for member states. Charles R. McManis, Intellectual Property and International Mergers and Acquisitions, 66 U. Cin. L. Rev. 1283, 1288 (1998). It is necessary to accede to TRIPS in order to join the WTO, but membership in the WTO has significant benefits, especially for developing nations. “Sections 1, 4, 5, and 7 . . .” relate to the protection of copyrights, industrial designs, patents, and trade secrets respectively. Waiver would permit nation states to provide intellectual property protections “in relation to prevention, containment or treatment of COVID-19” that fall below the minimum standard set by the TRIPs Agreement. At time of writing, 10 nations have cosponsored this proposal.

This proposal has been criticized as unnecessary. There is an argument that patents will not enter effect until after the current crisis is resolved, implying they will have no preclusive effect. However, as previously mentioned, it is a matter of fact that preexisting patents apply to therapies that are being used to treat SARS-CoV-2. Repurposing is common in the field of biotechnology where existing therapies are often repurposed or used as platforms, as is the case with mRNA vaccines. However, it is true that therapies directly developed in response to the pandemic are unlikely to be under patent protection in the near future given lag between filing for and receiving a patent. Others argue that if investors perceive biotech as an area where IP rights are likely to be undermined in the event of an emergency, it will reduce marginal investment in vaccine and biotech therapies. Finally, critics argue that the proposal ignores the existing mechanisms in the TRIPS Agreement that would allow compulsory licensing of therapies that nations feel are unavailable. Supporters of the status quo argue that voluntary licensing agreements can serve the needs of developing nations while preserving the investments in innovation made by larger economies.

The waiver sponsors respond that a wholesale waiver would permit greater flexibility in the face of the crisis, and be a more proportionate response to the scale of the emergency. They also assert that the preexisting compulsory licensing provisions are undermined by lobbying against compulsory licensing by opponents of the waiver, though it is unlikely that this lobbying would cease even if a waiver were passed. The sponsors also argue that the public investment implies that any research products are a public good and should therefore be free to the public.

It is unclear how the current debate on TRIPS will be resolved. The voluntary licensing agreements might end up abrogating the need for a wholesale waiver of IP protections in practice rendering the debate moot. However, the WTO should consider taking up the issue of IP protections in a crisis after the current emergency is over. The current debate is a reflection of a larger underlying disagreement about the terms of the TRIPS Agreement. Further, uncertainty about the status of IP rights in emergencies can dissuade investment in the same way as erosion of IP rights, implying that society may pay the costs of decreased investment without reaping any of the benefits.

 

How the U.S. Government Broke Its Treaty Obligations Before the Pandemic Struck: COVID-19 Illuminates How the U.S. Government Have Failed Native Communities

January 24, 2021
COVID-19, Health, Healthcare, Public Health

Ingrid Hofeldt, MJLST Staffer

As COVID-19 first began to ravage Native American tribal lands, the U.S. government’s treaty-solidified responsibility to protect tribes against external disasters was triggered. However, Native American communities’ reluctance to receive vaccinations showcases how the U.S. government’s treaty obligations require it to take proactive steps to ensure the advancement of healthcare on tribal lands and to attempt to mend the longstanding medical trauma of Native communities and resulting friction with the U.S. government.

Healthcare Disparities Before COVID-19

Since the invasion of Europeans, Native American communities have faced health crises. The European invaders both inadvertently spread smallpox, measles, and the flu, and launched biological warfare against Native communities. Around 90% of Native peoples were murdered or died through the spread of disease. Even after the most egregious periods of the genocide against Native Americans, indigenous communities continued to experience disparities in health outcomes. During the 1918 pandemic, the influenza struck Native populations with four times the severity of the general population, which resulted in 2% of Native peoples dying, and the near extinction of entire villages. 

Today, Native American communities continue to face disparities in health outcomes. Native Americans  have above average rates of immunocompromising diseases including diabetes, asthma, heart disease, cancer, respiratory diseases, hypertension, PTSD, and other mental health disorders. Native Americans are 600 times more likely than non-Native people to die of tuberculosis and 200 times more likely to die of diabetes. These rates exist in part because of the lack of resources available on reservations, which are home to 50% of the U.S. Native American population. Limited healthcare services, overcrowded housing, and lack of access to running water, proper sewage, and broadband internet[1] on reservations all contribute to reduced healthcare outcomes. A burgeoning elderly population, a quarter of whom lack health insurance, also adds to the difficulties facing Native healthcare services and tribal governments. 

The Crisis of COVID-19 for Native American communities and Reservations

Unsurprisingly, COVID-19 has spread across reservations like wildfire. Navajo Nation has had more deaths per capita than any state in the country. While Native Americans comprise 3% of Wyoming’s population and 6% of Arizona’s, they represent 33% and 16% of COVID-19 cases respectively. These disparities have emerged for a variety of reasons, from the higher rates of pre-existing conditions discussed above, which each exacerbate the severity and lethality of COVID-19, to lack of healthcare resources. Reservations experience the same shortages of doctors, hospitals, and medical resources common among rural areas. Additionally, limited grocery stores and multigenerational housing increase the risk of COVID-19 spread.

Beyond these existing disparities and lack of resources, the federal government’s mismanagement of resources designated for Native American communities has worsened the crisis of COVID-19 on reservations. While Congress distributed $80 million in COVID-19 relief funds to the Indian Health Services, 98% of tribal clinics have still not received their funds because of the federal government’s failure to properly disperse the funds. Testing has been largely absent from reservations, which causes cases to go unreported. Additionally, the federal government used census data, rather than tribal enrollment data,  to calculate distribution of resources in reservations. Because Native people are hugely undercounted in the census, reservations have received inadequate supplies of PPE, cleaning supplies, and tests. For example, the Sault Ste. Marie Tribe of Chippewa Indians only received 2 test kits for a population of 44,000. Meanwhile, the Seattle Indian Health Board was sent body bags in lieu of medical supplies. 

The U.S. Government’s Responsibility to Tribes

The U.S. government’s actions and inactions run afoul of multiple treaties, established case law, and the central tenants of Indian law. Numerous treaties between the U.S. government and tribal nations established tribes as sovereign political nations that the U.S. government must protect from external threats, ranging from foreign invasion to natural disasters. The Supreme Court has affirmed the dual sovereignty of tribal nations and the U.S. government’s obligations to tribes. 

Treaties between tribes and the U.S. government have both established this broad principle of the government’s responsibility to ensure the health and wellbeing of Native peoples and provided specific responsibilities requiring the U.S. government to provide vaccines, medicine, and physicians to Native peoples on reservations. In theory, the land tribes ceded to the U.S. government was a form of pre-payment for adequate healthcare. In 1955, the U.S. government established the Indian Health Services (IHS), to ensure that the U.S. government met its implied responsibility to ensure the adequate healthcare of Native peoples. Congress has also conceded that the U.S. government has a responsibility to “improve the services and facilities of Federal Indian health programs and encourage maximum participation of Indians” in those programs, which “the Federal Government’s historical and unique legal relationship with, and resulting responsibility to the American Indian people” requires. Congress has recognized that the current unmet health needs of tribes are “severe” and implicate “all other Federal services and programs in fulfillment of the Federal responsibility to Indians” which are “jeopardized by the low health status of the American Indian people.” 

How the U.S. Government Has Violated Its Treaty Obligations During the COVID-19 Crisis

As the U.S. government charges forward with the COVID-19 vaccination program, the COVID-19 healthcare disparities and the long history of medical trauma in Indian country compound one another. Many Native Americans living on reservations express skepticism over the vaccine program given the genocide committed against Native peoples through medicine and the government’s current mishandling of the COVID-19 crisis. Currently, an estimated 50% of people on the Spirit Lake Reservation do not plan to receive vaccinations. While the government spent centuries committing biological warfare against Native peoples, the medical community has enacted great harm against Native people relatively recently. Within the past 100 years, the U.S. government has conducted testing of radioactive iodine on Alaska Natives and widely distributed vaccines that proved less effective or ineffective for Native people. In the 1970’s, the U.S. government mass sterilized Native Americans without their consent. Further, in 2009, the U.S. government mishandled the H1N1 crisis on reservations, exacerbating this existing lack of trust. 

The tenuous relationship between tribes and the government has only worsened during the COVID-19 crisis as a result of the mismanagement of tribal healthcare. Many Native people worry that the federal government is withholding the risks of the COVID-19 vaccine. Native healthcare providers stress that the U.S. government must work to cultivate community support for its healthcare initiatives and ensure informed consent from each Native person for any medical procedure. The longstanding, positive relationship between Johns Hopkins University medical researchers and the Navajo people is a testament to the benefits of long standing relationships between tribes and researchers built on trust.

In light of the long history of healthcare issues and violations on reservations, the current mishandling of the COVID-19 crisis on reservations, and the fear of vaccination in many tribal communities, it becomes clear that the U.S. government’s treaty obligations related to healthcare must be rethought, recalibrated, and redefined. The U.S. government should not merely intervene when a pandemic strikes, but should take proactive, constructive steps before crisis strikes to ensure that Native peoples will receive adequate healthcare during both normal times and widespread calamities. It was no secret to the government that a pandemic would prove disastrous for tribes: public health experts have long foreshadowed the severity of a pandemic for tribal populations. Merely throwing money at tribes once disaster strikes will not solve the longstanding health and healthcare issues on reservations that complicate the virus. 

 Funds alone cannot solve the complex, socio-political healthcare issues complicated by historical trauma. Beyond dispersing funds through IHS, the U.S. government should consider organizing focus groups on reservations between elders, traditional healers, tribal government leaders, and immunologists from the CDC and public health officials to discuss steps moving forward. Additionally, to ensure treaty obligations, the U.S. government must tackle the more difficult long standing issues such as the lack of agency tribes hold over medical research and the distrust between the federal government and Native communities. To achieve equitable healthcare for tribes, Native people cannot merely be pushed to the sidelines as participants or involved minimally as nurses and doctors but not as researchers. The federal government should use funds to ensure that young Native Americans have available programming on science, STEM careers, and pathways into medicine. While not a conclusive end to the medical trauma Native communities have experienced, providing partnerships in medical research to researchers from Native communities will hopefully both shed a spotlight on healthcare disparities within Native communities and rebuild the frayed and broken trust between Native communities and medical researchers. 

Regardless of what steps are taken, the strength and organizing of Native communities during the COVID-19 pandemic deserves recognition. In the words of Jonathan Nez, Navajo Nation president, “We are resilient . . . our ancestors got us to this point . . .  now it is our turn to fight hard against this virus.”

 

[1] 13% of American Indian/Alaska Native homes lack running water or sewage compared to 1% of homes nationwide. In the Navajo Nation, ⅓ of homes lack running water.

COVID-19 Vaccination: Pervasive Skepticism and Employer Mandates in the United States

December 6, 2020
COVID-19, Employment, Food and Drug Law, Public Health

Drew Miller, MJLST Staffer

On December 31, 2019, the COVID-19 pandemic began when the World Health Organization’s (WHO) Chinese office picked up a media statement by the Wuhan Municipal Health Commission regarding cases of “viral pneumonia.” Nearly a year later, despite the protective measures instituted on a global scale to slow the spread, COVID-19 has claimed the lives of nearly 1,500,000 people worldwide) and shows no sign of slowing down. All hope is not lost; scientists and biopharmaceutical companies have worked diligently throughout the crisis, and a large-scale vaccination release seems imminent. However, given the prevalence of anti-vaccination sentiment in the United States, it may be difficult to distribute the vaccine to enough people; employer-mandated vaccines likely offer the best chance for widespread vaccination, but the standards governing such mandates remain unclear.

Anti-Vaccination Sentiment in the US

Whether the vaccine will provide outright immunity or simply partial protection, it will regardless be a critical step toward ending the pandemic. However, vaccines are obviously only effective if people agree to get the shot, and that may prove to be a significant barrier in the United States. Vaccine doubt and anti-vaccination movements continue to grow in popularity for a variety of reasons. Social media’s unique ability to bring together like-minded individuals across the globe inevitably results in the creation of insular groups; anti-vaccine support from celebrities such as Jenny McCarthy and Jim Carrey provide a degree of validation to “regular” people who feel the same way; and general government distrust, which has sharpened considerably under the tumultuous and polarizing Trump presidency, heightens suspicions surrounding FDA testing and approval processes. Finally, as noted by Dr. Paul A. Offit, an infectious disease expert and co-inventor of a vaccine for rotavirus, “Vaccines are a victim of their own success. We have largely eliminated the memory of many diseases.”

Moreover, skepticism regarding the safety and efficacy coronavirus vaccine is not entirely unfounded. The vaccine development process typically takes a decade, whereas this one began under a year ago. A group of researchers at the Johns Hopkins Center for Health Security and the Texas State University anthropology department writes, “If poorly designed and executed, a COVID-19 vaccination campaign in the U.S. could undermine the increasingly tenuous belief in vaccines and the public health authorities that recommend them – especially among people most at risk of COVID-19 impacts.” The results of a poll conducted by Pew Research Center in September indicates the consequences of all these factors: just over half (51%) of U.S. adults definitely or probably would get a COVID-19 vaccine if it were available today—a 21% drop from 72% in May.

Employer-Mandated Vaccines

With skepticism at an all-time high, the responsibility for raising vaccination rates in the U.S. may fall to employers. The U.S. Occupational Safety and Health Administration (OSHA) allows employers to legally impose an influenza vaccine requirement on their workers, but there are several requirements and exceptions that make such a mandate more difficult to impose.

First, employees are entitled under the Americans with Disabilities Act (ADA) to request medical and disability exemptions. This exemption requires proof of an underlying disability or medical condition that renders an employee essentially unable to safely get the vaccine. Second, employees may also claim religious exemptions to avoid an employer-mandated vaccine. However, Title VII of the Civil Rights Act of 1964 states that an employee must have a “sincerely held religious belief” against vaccination. In 2020, the Third Circuit Court of Appeals held that an employee’s “holistic health lifestyle” and personal belief that vaccines are harmful were insufficient to trigger protection under the Civil Rights Act. See Brown v. Children’s Hosp. of Philadelphia, 794 Fed. Appx. 226 (3rd Cir. 2020). The court wrote, “[I]t is not sufficient merely to hold a ‘sincere opposition to vaccination’; rather, the individual must show that the ‘opposition to vaccination is a religious belief.’” Id. (citing Fallon v. Mercy Catholic Med. Ctr. of Southeast Pa., 877 F.3d 487, 490 (3rd Cir. 2017)).

There are two primary standards governing the situations in which employers may legally require vaccinations regardless of religious or medical exemptions. Title VII does not require employers to make “reasonable accommodations” for medical or religious reasons if it would pose an undue hardship, which it defines as “more than de minimis cost” to the operation of the business. The ADA standard is stricter, requiring reasonable accommodation barring undue hardship, which it defines as an “action requiring significant difficulty or expense.”

Finally, because vaccinations are “medical examinations” under the ADA, the COVID-19 vaccine would need to be deemed “job-related, consistent with business necessity or justified by a direct threat, and no broader or more intrusive than necessary.” Although the Equal Employment Opportunity Commission (EEOC), which is responsible for enforcing federal anti-discrimination laws in employment, has labeled COVID-19 as a “direct threat” to the workplace and stated that employers are allowed under the ADA to “bar an employee from physical presence in the workplace if he refuses to have his temperature taken or refuses to answer questions about whether he has COVID-19, has symptoms associated with COVID-19, or has been tested for COVID-19,” it has not yet stated whether employers will have the right to make a vaccine mandatory.

Conclusion

As such, the rights of employers to legally impose COVID-19 vaccination requirements on employees are uncertain and, absent clear direction or regulation, will likely require case-by-case analysis to determine the validity of each exemption and the corresponding hardship to business. Consequently, even if employers do have the legal right, protracted legal battles are the only remedy, and given the pervasive fear of vaccinations in today’s social climate, there are likely to be a great many of them. Meanwhile, the COVID-19 pandemic will continue to ravage the nation.

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