Public Health

Behind the “Package Insert”: Loophole in FDA’s Regulation of Off-Label Prescriptions

Yolanda Li, MJLST Staffer

FDA Regulation of Drug Prescription Labeling and the “Package Insert”

Over the recent years, constant efforts have been made towards regulating medical prescriptions in an attempt to reduce risks accompanied with drug prescriptions. Among those efforts is the FDA’s revision of the format of prescription drug information, commonly known as the “package insert”.[1]

The package insert regulation, effective since 2006, applies to all prescription drugs. The package insert is to provide up-to-date information on the drug in an easy-to-read format. One significant feature is a section named “highlights”, which provides the most important information regarding the benefits and risks of a prescribed medication. The highlights section is typically half a page in length providing a concise summary of information including “boxed warning”, “indications and usage”, and “dosage and administration”.[2] The highlights section also refers physicians to appropriate sections of the full prescribing information. In this way, the package insert aims to draw both the physicians’ and the patients’ attention to the prescription of a drug, consequently accomplishing the ultimate purpose of managing medication use and reducing medical errors. Mike Leavitt, the Health and Human Services Secretary of the FDA commented that the package insert “help[s] ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare.”[3]

FDA Regulation of Off-Label Prescription and the Emergence of a Loophole

The FDA’s regulations relating to the labeling of prescription drugs, although systematic in its form, are cut short to a certain extent due to its lack of regulation on off-label prescriptions. Off-label prescriptions do not refer to a physician prescribing non-FDA approved drugs, a common misunderstanding by the public. Rather, off-label prescriptions are those that do not conform to the FDA-approved use set out in the FDA-approved label.[4] More specifically, off-label prescription generally refers to: “(1) the practice of a physician prescribing a legally manufactured drug for purposes other than those indicated on that drug’s FDA mandated labeling; (2) using a different method of applying the treatment and prescribing a drug, device, or biologic to patient groups other than those approved by FDA; and (3) prescriptions for drug dosages that are different from the approved label-recommended dosage or for time periods exceeding the label-recommended usage.”[5] For example if Drug A’s use, as mandated by the FDA, is to treat chronic headaches, and a physician prescribes it to treat a patient’s sprained ankle, that is an off-label prescription. However, such practice is common as estimated by the American Medical Association (AMA).[6]

The commonly approach is that the FDA and courts do not to interfere with physicians’ off-label uses.[7] Thus, when the FDA regulates the labeling of approved uses but does not regulate prescriptions for off-label uses, a loophole is formed. Andrew von Eschenbach, M.D., claims that because the FDA’s package insert regulation makes it easier for physicians to get access to important information about drugs, including drug safety and benefits, this regulation helps physicians to have more meaningful discussions with patients.[8] However, physicians’ discretion in prescribing off-label prescriptions would offset the proposed benefit of the FDA regulation because the regulation remains as guidance without force of law once physicians choose to go off from FDA’s approved uses of drugs. The easy-to-understand feature of the package insert and its benefit for a patient’s understanding of the drug becomes futile when physicians exercise discretion and prescribe drugs for uses not written on the inserts. In sum, when a patient receives an off-label prescription, the insert provides them little benefit as it addresses benefits and risks related to a different use of the drug.

It is undisputed that drug manufacturers have less discretion regarding drug labeling than physicians. If a manufacturer included an off-label use on a drug’s label, and promoted the off-label use of the drug, the drug would be considered misbranded. The manufacturer would then be subject to liability[9] as manufacturing a misbranded product in interstate commerce is prohibited.[10] However, the effect of regulations on manufacturers still fail to eliminate the loophole in off-label prescription: in response to the regulations, the manufacturer usually receives FDA approval for only a few drug uses and then relies on physicians prescribing off-label uses to ensure their profitability.[11] In this way, the manufacturer avoids liability under regulation and furthers the loophole in off-label prescription by encouraging physicians to prescribe more off-label uses in order to expand the manufacturer’s market.[12]

Why are Off-Label Prescriptions Difficult to Regulate?

One of the main reasons behind the lack of regulation of off-label prescriptions is the FDA’s objective in ensuring effective delivery of health care. Physicians are encouraged to use discretion and judgment in order to tailor prescription to patients’ individual conditions.[13] Another reason is to increase efficiency in treatments by avoiding the lengthy FDA approval process.[14] Aspirin was widely prescribed to reduce the risk of heart attack long before it was FDA-approved for this purpose; off-label prescriptions have also been proven effective in treatment of cancer, and off-label therapies have prolonged the lives of AIDS patients.[15] Another concern is drug prices in the United States, and promoting off-label uses has been found to help reduce drug prices as increased sales volume enables drug companies to lower their prices.[16] Indeed, off-label prescription has become a mainstream of medicine: “the FDA has long tolerated off-label drug use and has disclaimed any interest in regulating physicians’ prescribing practices.”[17] Today it is unclear whether the agency even has jurisdiction to regulate off-label prescription of drugs.[18]

In sum, there is clear guidance on the labeling of prescription drugs as a result of FDA regulation. However, because of difficulties in enforcement, the custom and widely accepted practice of off-label prescriptions and the inherent benefit of off-label prescription, the effects of the regulation are not as effective as what was firstly planned and proposed.

Notes

[1] The FDA Announces New Prescription Drug Information Format, U.S. Food & Drug Adm’ (Dec. 04 2015) https://www.fda.gov/drugs/laws-acts-and-rules/fda-announces-new-prescription-drug-information-format.

[2] Id.

[3] Id.

[4] Margaret Z. Johns, Informed Consent: Requiring Doctors to Disclose Off-Label Prescriptions and Conflicts of Interest, 58 Hastings L.J. 967, 968 https://plus.lexis.com/document?crid=35364c11-2939-4e58-bceb-dab7ae8f0154&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A4P0W-GY20-00CW-906B-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=7341&pdmfid=1530671&pdisurlapi=true.

[5] Lisa E. Smilan, The off-label loophole in the psychopharmacologic setting: prescription of antipsychotic drugs in the nonpsychotic patient population, 30 Health Matrix 233, 240 (2020), https://plus.lexis.com/document/?pdmfid=1530671&crid=367cf8ad-295e-4f14-97fa-737618718d61&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A64BT-RR31-JWBS-61KV-00000-00&pdworkfolderid=5506aeec-9540-4837-89f0-5a1acfd81d8b&pdopendocfromfolder=true&prid=1d42abd0-b66e-43af-a61a-0d1fb94180f5&ecomp=gdgg&earg=5506aeec-9540-4837-89f0-5a1acfd81d8b#.

[6] Supra note 4.

[7] Sigma-Tau Pharms. v. Schwetz, 288 F.3d 141, 148, https://plus.lexis.com/document?crid=7d2a2b00-13ad-4953-968e-82a28724aa00&pddocfullpath=%2Fshared%2Fdocument%2Fcases%2Furn%3AcontentItem%3A45RF-5H50-0038-X1PB-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=6388&pdmfid=1530671&pdisurlapi=true.

[8] Supra note 1.

[9] 21 CFR 201.5, https://plus.lexis.com/document/?pdmfid=1530671&crid=e02a99fb-be65-4525-b83c-a167f3e21b93&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A603K-BXD1-DYB7-W30Y-00000-00&pdcontentcomponentid=5154&pdworkfolderlocatorid=NOT_SAVED_IN_WORKFOLDER&prid=ff2b7e20-9dab-49b0-8385-627c16ee0ba2&ecomp=vfbtk&earg=sr2.

[10] 21 CFR 801.4, https://plus.lexis.com/document/?pdmfid=1530671&crid=721a586d-52a4-4228-b0c3-c464a77d6e6a&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A638R-X4S3-GXJ9-32FV-00000-00&pdcontentcomponentid=5154&pdworkfolderlocatorid=NOT_SAVED_IN_WORKFOLDER&prid=ff2b7e20-9dab-49b0-8385-627c16ee0ba2&ecomp=vfbtk&earg=sr6.

[11]  Supra note 4.

[12] Id.

[13]   Supra note 7.

[14]   Supra note 4.

[15]  Id.

[16] Supra note 4, at 981.

[17] ​​Kaspar J. Stoffelmayr, Products Liability And “Off-label” Uses Of Prescription Drugs, 63 U. Chi. L. Rev. 275, 279, https://plus.lexis.com/document?crid=a2181ffc-7f3e-4bce-b82e-08ba9111194f&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A3S3V-4CF0-00CV-K03W-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=7358&pdmfid=1530671&pdisurlapi=true.

[18]  Id.


Whisky Is for Drinking, Water Is for Fighting

Poojan Thakrar, MJLST Staffer

The American Southwest often lives in our imagination as an arid environment with tumbleweeds strewn about. This hasn’t been truer in centuries, as the Colorado River is facing its worst drought in 1200 years, in large part because of climate change.[1] The Colorado River is the region’s most important river, providing drinking water to about 40 million people.[2] In June, the federal government gave the seven states[3] that rely on the water two months to draft a water conservation agreement or risk federal intervention. The states blew past that deadline and the DOI’s Bureau of Reclamation imposed cuts to water usage as high as 21%.[4]

The History of the Modern Colorado River Allocation System

In 1922, the Colorado River Compact allocated an annual amount of 15 million acre-feet (maf) evenly between the Upper and Lower Basin states.[5] One acre-foot represents the volume of water that covers one acre in one foot of water and is about the amount of water that a family of four uses annually.[6] However, relying on 15 maf was already problematic; data from the past three centuries showed that the Colorado River has average flows of 13.5 maf, with some years as low as 4.4 maf.[7] 

Moreover, Arizona refused to sign this compact, arguing that water should be allocated amongst individual states instead of between river basins.[8] Tensions flared in 1935 as Arizona moved National Guard troops to the California border in protest of a new dam.[9] Arizona finally ratified the compact in 1944, but the disagreements were far from over.[10] 

Arizona also brought a case to the Supreme Court for a related dispute, asking the Supreme Court to allocate how each basin splits water according to the Boulder Canyon Project Act of 1928.[11] Originally filed in 1952, Arizona v. California was not resolved until a Supreme Court opinion in 1963.[12] In the end, the Supreme Court accepted the recommendations of a court-appointed Special Master, whose findings California disagreed with. Of the 7.5 maf allocated to the Lower River Basin, 4.4 maf was allocated to California, 2.8 maf to Arizona and 0.3 to Nevada.[13] The court affirmed each state’s use of their own tributary waters, which Arizona argued for.[14] The case also affirmed the Secretary of the Interior’s authority under the Boulder Canyon Project Act to allocate water amongst the states irrespective of their agreement to a compact.[15] Ultimately, this was a victory for Arizona. 

Colorado River water use has been less contentious since Arizona v. California. The Upper Basin states of Colorado, Utah, Wyoming, and New Mexico signed a contract to divide their 7.5 maf amongst themselves without the need for federal intervention.[16] However, because of comparatively less development in these Upper Basin states, they collectively only use 4.4 maf of their allocated 7.5 maf.[17] California has historically enjoyed the excess and has often historically surpassed its own allocation.[18]

Modern Water Allocation

Until this year, the seven Colorado River states have relied on voluntary agreements and cutbacks to manage water allocation. For example, in 2007, the states agreed to rules which decreased the amount of water that can be drawn from reservoirs when levels are low.[19] In 2019, they agreed to Drought Contingency Plans (DCPs) in the face of waning reservoir levels.[20] It was under this new DCP that the Bureau of Reclamation first announced a drought in August of 2021.[21] Later that December, the Lower Basin states were able to come to an agreement regarding the drought declaration to keep more water in Lake Mead, a reservoir on the Colorado.[22]

However, the December 2021 cutbacks were presumably not enough. In June of 2022, Bureau of Reclamation Commissioner Camille Calimlim Touton testified in front of the Senate Energy Committee about the dire situation on the Colorado.[23] She testified that Lake Powell and Lake Mead, both reservoirs on the Colorado, cannot sustain the current level of water deliveries.[24] Commissioner Tounton gave the seven states 60 days to agree how to conserve 2 to 4 maf.[25] 

Underlying this recent situation is the megadrought that the western United States has suffered since 2000.[26] The last 20 years have been the driest two decades in the past 1200 years.[27] The Colorado River states have become remarkably adept at conserving water in that time. For example, the Las Vegas basin’s population has grown by 750,000 in the past 20 years, but its water usage is down 26%.[28] Earlier this year, Los Angeles banned lawn watering to only one day a week, much to the chagrin of Southern California’s most famous residents.[29] 

Commissioner Tounton’s 60 day deadline came and went without an agreement.[30] During a speech on August 15th of this year, Commissioner Tounton mandated that the seven states have to cut their water usage by 1 maf, roughly the amount of water usage of four million people.[31] However, the cuts were not proportioned equally. Arizona was mandated to cut its water by 21% because of the old water agreements, while California was not required to make any.[32]

More recently on October 5th, several California water districts volunteered cuts of almost one-tenth of their total allocation.[33] California conditioned these cuts upon other states agreeing to similar reductions, as well as on incentives from the federal government.[34] California’s cuts are significant, representing roughly 0.4 maf of the 1 maf that Commissioner Tounton asked states to conserve in her August 15th statement.[35] This represents a bold, good-faith move considering California was not mandated to make any. However, there is no doubt that these ad hoc negotiations are unsustainable. As the drought continues, Colorado River water policy will have implications on how food is grown and where people live. The 40 million people that live in the American Southwest may see their day-to-day lives affected if a solution is not crafted. Ultimately, this situation is far from over as states are forced to come to grips with a new water and climate reality.

Notes

[1] The Journal, The Fight Over Water In The West, Wall Street Journal, at 00:50 (Aug. 23, 2022) (downloaded using Spotify).

[2] Luke Runyon, 7 states and federal government lack direction on cutbacks from the Colorado River, NPR (Aug. 27, 2022, 5:00 AM) https://www.npr.org/2022/08/27/1119550028/7-states-and-federal-government-lack-direction-on-cutbacks-from-the-colorado-riv.

[3] Wyoming, Colorado, Utah, and New Mexico are considered Upper Basin states and California, Arizona and Nevada are the Lower Basin states.

[4] The Journal, supra note 1, at 12:30.

[5] Joe Gelt, Sharing Colorado River Water: History, Public Policy and the Colorado River Compact, The University of Arizona (Aug. 1997), https://wrrc.arizona.edu/publications/arroyo-newsletter/sharing-colorado-river-water-history-public-policy-and-colorado-river.

[6] The Journal, supra note 1, at 8:08.

[7] Gelt, supra note 5.

[8] Id.

[9] Nancy Vogel, Legislation fixes borders wandering river created; Governors of Arizona, California sign bills to get back land the Colorado shifted to the wrong state, Contra Costa Times, Sept. 13, 2002.

[10] Gelt, supra note 5.

[11]  Arizona v. California, 373 U.S. 546 (1963).

[12] Supreme Court Clears the Way for the Central Arizona Project, Bureau of Reclamation https://www.usbr.gov/lc/phoenix/AZ100/1960/supreme_court_AZ_vs_CA.html.

[13] Arizona v. California, 373 U.S. 546, 565, 83 S. Ct. 1468, 1480 (1963).

[14] Id.

[15] Id.

[16] Gelt, supra note 5.

[17] Heather Sackett, Water managers set to talk about how to divide Colorado River, Colorado Times (Dec. 13, 2021) https://www.steamboatpilot.com/news/water-managers-set-to-talk-about-how-to-divide-colorado-river.

[18] Gelt, supra note 5.

[19] Lower Colorado River States Reach Agreement to Reduce Water Use, Renewable Natural Resources Foundation (Feb. 4, 2022) https://rnrf.org/2022/02/lower-colorado-river-states-reach-agreement-to-reduce-water-use/.

[20] Id.

[21] Id.

[22] Id.

[23] Marianne Goodland, Reclamation official tells Colorado River states to conserve up to 4 million acre-feet of water, Colorado Politics(June 15, 2020) https://www.coloradopolitics.com/energy-and-environment/reclamation-official-tells-colorado-river-states-to-conserve-up-to-4-million-acre-feet-of/article_376a907a-ece6-11ec-b0ba-6b2e72447497.html.

[24] Id.

[25] Id.

[26] Ben Adler, ‘Moment of reckoning:’ Federal official warns of Colorado River water supply cuts, Yahoo News (June 15, 2020) https://news.yahoo.com/moment-of-reckoning-federal-official-warns-of-colorado-river-water-supply-cuts-171955277.html.

[27] Id.

[28] The Journal, supra note 1, at 5:50.

[29] Id. at 6:10.

[30] Id. at 8:55.

[31] Id. at 10:05.

[32] Id.

[33] Marketplace, Why women have been left behind in the job recovery, American Public Media, at 11:35 (Oct. 6, 2022) (downloaded using Spotify).

[34] Id.

[35] Ian James, More water restrictions likely as California pledges to cut use of Colorado River supply, L.A. Times, (Oct. 6, 2022) https://www.latimes.com/california/story/2022-10-06/southern-california-faces-new-water-restrictions-next-year.


Making Moves on Marijuana: President Biden and Minnesota Update Marijuana Laws in 2022

Emma Ehrlich, MJLST Staffer

Federal Pardoning 

Earlier this month, President Biden announced that he would be pardoning anyone with a federal conviction due to simple marijuana possession charges. This will affect approximately 6,500 people on the federal level, plus thousands of others who were convicted in the District of Columbia. However, this pardon does not cover anyone involved in the actual sale of marijuana or anyone convicted under state possession laws, meaning it affects only a subsection of those who have been convicted of marijuana related charges. The administration’s goal was to give a clean slate to those who were struggling to find housing or employment due to a possession charge, and to encourage state legislatures to do the same. 

The second half of President Biden’s announcement was to task the Attorney General with reviewing the federal government’s categorization of marijuana as a Schedule 1 drug, which President Biden pointed out is currently the same categorization as heroin. Drugs are supposed to be assigned to schedules based on their medical uses and addictive qualities. The Drug Enforcement Agency (“DEA”) currently categorizes marijuana as a “drug[] with no currently accepted medical use and a high potential for abuse.” The U. S. Food and Drug Administration (“FDA”) explains on their website, almost in a regretful tone, that only four cannabis drugs have been approved by the FDA, one containing CBD and the other three containing synthetically derived THC. This categorization issue is not new, but because legislation regarding marijuana is changing rapidly federal agencies have had to play catch up with the law.  

Minnesota and Beyond 

Meanwhile, the state of Minnesota is still chugging along in terms of marijuana legalization. In July of this year, the state of Minnesota legalized the production and sale of edibles containing 5-mg of THC, which can now be purchased by adults in bags containing no more than 50-mg of THC. This sounds like good news, but many state residents are baffled at the lack of a tax provision in the new state law. The University of Maryland actually did a study on Minnesota’s potential for taxing cannabis, and determined that if the newly legalized edibles were taxed at the same rate as Michigan taxes, the state could have collected over $40 million. Given this high estimate, it is not out of the question that a tax on marijuana will be implemented in the future. 

Minnesotan employers were similarly not thrilled when the law passed as they felt ill equipped to update their drug policies. Employers “can bar workers from using, possessing, and being under the influence of THC during work hours or in the workplace,” as well as conduct “random drug testing for safety-sensitive positions” and “employees suspected of being intoxicated.” The gray area exists in the employer’s ability to hire and fire based on an applicant or employee’s use of marijuana outside of work. It is currently illegal to make hiring and firing decisions based on tobacco usage or alcohol consumption, and it is unclear if marijuana will be treated in the same manner. The added layer to marijuana testing is that a positive drug test for marijuana does not mean an employee consumed THC right before work since THC lingers in the body for so long. Thus, an employee could test positive for mairjuana at work even if they had used the drugs days ago and were no longer feeling its effects. Though the employee would have ingested the drug legally, they may not be considered for a job position or could be fired from a job they already hold. This is the type of issue that has led a number of municipalities in Minnesota to put a pause on the sale of the state legalized edibles. In contrast, California passed a law just last month protecting employees, apart from some exceptions, from being discriminated against based on their marijuana usage when not at work. What might be a little concerning is that California made recreational marijuana legal in 2016, and this law won’t go into effect until 2024, meaning there was an eight year gap in the legislation. Regardless, this may serve as the beginning of a pattern, pointing to what Minnesota may do down the line. 

In 2020 New Jersey passed a law legalizing recreational marijuana use which went into effect in April of this year. Similarly to California, part of the law protects workers from being discriminated against because of their marijuana use outside of work. However, Walmart and Sam’s Club have continued to administer drug tests to job applicants to search for traces of marijuana, a practice that has gotten them into legal trouble in New Jersey. Walmart is arguing that only the state Cannabis Regulatory Commission can enforce the new employment law, and that this case should be dismissed because it was brought by individuals. Courts in other states in which similar laws have been passed have issued decisions that oppose Walmart’s position, ruling that individual workers can sue under the law. It seems that Minnesota is not the only state that has enacted fuzzy recreational drug use laws that directly affect employers and employees. 

On the bright side of this employment confusion, many appreciate the baby step the Minnesota legislature has taken to legalize marijuana use. The state has been in dire need of updated marijuana legislation, and the hope is that continuing this legalization process will lessen the disparities between black and white arrests for marijuana possession. This change is necessary, because as of 2020 Minnesota was found to rank 8th in the United States for largest racial disparities in marijuana possession arrests. In 2021, the Minnesota Bureau of Criminal Apprehension released data showing that out of the over 6,000 marijuana related arrests made in the state, 90% were for simple possession charges, and a black person was almost five times more likely to be arrested for these types of charges than a white person. This statistic is down from almost eight times more likely back in 2010, but is still extremely present. 

In Conclusion

President Biden’s pardon is just a beginning step towards moving the US forward on marijuana legislation. Though states such as Minnesota are moving in the right direction by gradually legalizing recreational marijuana use, the laws are often unclear and lead to a multitude of logistical issues like those seen in the employment sector. Regardless, making continued progress is important to the U.S. for many reasons and is crucial for helping to lessen racial arrest disparities. Hopefully this pardon will have the effect the administration aimed for and will encourage more state legislatures to update their policies on marijuana usage.

 

 


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

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.

 


You Gotta Fight for Your Right to Repair

Christopher Cerny, MJLST Staffer

Last spring, as the first wave of the coronavirus pandemic hit critical heights, many states faced a daunting reality. The demand for ventilators, an “external set of lungs” designed to breathe for a patient too weak or compromised to breathe on their own, skyrocketed. Hospitals across the United States and countries around the globe clamored for more of the life saving devices. In March and April of 2020, the increasing need for this equipment forced doctors in Washington State, New York, Italy, and around the world to make heartbreaking decisions to prioritize the scarce supply. With this emergency equipment operating at maximum capacity, any downtime meant another potential life lost. But biomeds, hospital technicians who maintain these crucial medical devices, were frequently unable to troubleshoot or repair out-of-service ventilators to return them to the frontlines. This failure to fix the much-needed equipment was not due to lack of time or training. Instead, it was because many manufacturers restrict access to repair materials, such as manuals, parts, or diagnostic equipment. According to one survey released in February 2021, 76% of biomeds said that manufacturers denied them access to parts or service manuals in the previous three months and 80% said they have equipment that cannot be serviced due to manufacturers’ restrictions to service keys, parts, or materials.

While the prohibition of repairs of life support equipment highlights the extreme danger this restriction creates, the situation is not unique to hospitals and emergency equipment. As technology becomes increasingly complex and proprietary, all manner of tech manufacturers are erecting more and more barriers that prevent owners and independent repair shops from working on their products. Tesla, for example, is adamant about restricting repairs to its vehicles. The electric vehicle auto maker will not provide parts or authorize repairs if performed at an uncertified, independent repair shop or end user. Tesla has gone so far as to block cars repaired outside of its network from using its Superchargers. Apple historically also prevented end users from performing their own repairs, utilizing specialized tools and restricting access to parts. John Deere requires farmers to comply with a software licensing agreement that is in appearance designed to protect the company’s proprietary software, but in practice prevents farmers from clearing error codes to start their farm equipment without an authorized technician.

In response to these obstructions to repair, the Right to Repair movement solidified around the simple proposition that end users and independent repair shops should be provided the same access to manuals and parts that many tech companies reserve solely to themselves or their subsidiaries. This proposition is catching on and the legislatures in twenty-five states are currently considering thirty-nine bills involving the right to repair. However, of the thirty-nine bills, only three address medical technology with the bulk of the proposals devoted to general consumer products—think appliances, iPads, and smart devices—and farm equipment.

Massachusetts is an early adopter of right to repair laws. Its legislature passed a law in 2012 specific to motor vehicles that, inter alia, standardized diagnostic and service information, mandated its accessibility by owners and independent or third-party repair shops, and established any violation of the provisions of the act as an unfair method of competition and an unfair trade practice. This past November, Massachusetts voters approved a ballot measure that expanded the scope of the 2012 right to repair law and closed a loophole that could circumvent the requirements imposed in the earlier statute. Automakers lobbied in force to oppose the measure, spending in excess of $25 million in advertising and other efforts. Taking into account the money spent by both sides of the ballot measure, the right to repair initiative was the most expensive measure campaign in Massachusetts history. The European Union is also taking steps to broaden access to repair materials and information. The European Parliament passed a resolution aimed at facilitating a circular economy. Acknowledging the finite nature of many of the rare elements used in modern technology, the European Union is aiming to make technology last longer and to create a second-hand market for older models. The resolution expanding repair access is a part of that effort by ensuring the ease of repair to prolong the life of the technology and delay obsolescence.

Some manufacturers are making concessions in the face of the Right to Repair Movement. Apple, notoriously one of the most restrictive manufacturers, did an about face in 2019 and expanded access to “parts, tools, training, repair manuals and diagnostics” for independent repair businesses working on out of warranty iPhones. Tesla opened its repair platform to independent repair shops in the European Union after the EU Commission received complaints, but the access can be prohibitively expensive at €125 per hour for the use of diagnostics and programming software. However, these minimal efforts are stop-gap measures designed to slow the tide of legislation and resolutions aimed at broadening access to the materials needed to perform repairs to break the monopolistic hold manufacturers are trying to exert over routine fixes.

The Right to Repair movement is clearly gaining ground as the implications of this anticompetitive status quo in the repair and second-hand market was brought into stark relief by the strains imposed by the COVID-19 pandemic, which strained not only hospitals but agriculture, infrastructure, and day-to-day life. The impact of these restrictions on independent repair shops, farmers, consumers, patients, and do-it-yourselfers more than ever became an obvious impediment to health, safety, and a less extractive economy. And as shown in Massachusetts, voters are responding by expanding the right to repair, even in the face of expensive lobbying and advertising campaigns. Legislators should continue to bring additional bills, especially addressing the restrictions on repairs of emergency medical equipment and should enact the existing proposals in the twenty-five states currently considering them.


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

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.


Everything’s Bigger in Texas, Including Power Outages

Madeline Vavricek, MJLST Staffer

On last week’s episode of “now what?”, Texas was experiencing massive power shortages following a winter storm, leaving hundreds of thousands of Texans without power and water. An estimated 4.3 million Texans were rendered without power for up to a week as the cold snap that swept the nation caused Texas’s power grids to fail. Though the power grid is back up and Texas has returned to its regularly scheduled spring temperatures, last month’s empty grocery store shelves and power shortages have yet to melt from many Texans’ memories. As massive electric bills arrive in citizens’ mailboxes (hello, surge pricing!), lawsuits levied against power companies, and bankruptcies filed by energy companies, one might ask why Texas, far from being the coldest part of the United States that week, was so thoroughly and singularly felled by the winter weather. The answer, perhaps unsurprisingly, is both political and economic, and requires a history lesson as well.

Nearly half a century after Thomas Edison’s 1880 invention of the light bulb, the advent of the power grid was gaining traction in the nation’s cities and becoming less of a luxury and more of a necessity. This created a highly profitable market for electricity where previously no market had existed, and the expansion of the industry only shed light on ways that electric companies were utilizing the novel market to their advantage. This expansion eventually lead to the passage of the 1935 Public Utility Holding Company Act (PUHCA) under President Franklin D. Roosevelt. The Act outlawed the “pyramidal structure” of interstate utility holding companies, preventing holding companies from being more than twice removed from their operating subsidiaries, and required companies with a ten percent stake or greater in a utilities market to register with the Securities and Exchange Commission for monitoring. Essentially, this legislation was to prevent energy companies from operating as monopolies in the relatively new energy market, a move met with vehement opposition by the utility companies themselves; the bitter feeling was mutual, with FDR notably calling the holding companies “evil” in his 1935 State of the Union address.

While PUHCA inconvenienced these villainous utility companies’ interstate operations, there was one loophole left available to them: their “evil” was left unregulated within the state, allowing holding companies that operated within a single state unregulated under PUHCA.  While the Act was effective, decreasing the number of holding companies from 216 to 18 between 1938 and 1958, creating a “a single vertically-integrated system which served a circumscribed geographic area regulated by either the state or federal government.” It was following the 1935 passage of PUHCA that Texas power companies decided to band together within the state rather than submit to the federal regulation at hand. By only operating within state lines, Texas companies effectively skirted federal regulation and interference, politically maneuvering itself to an energy independence largely made possible through Texas’s energy-rich natural resources.

In the late sixties, the federal government created two main power grids to serve the country: the Eastern Interconnection and the Western Interconnection. Texas opted out of this infrastructure, choosing instead to form its own grid operator, called the Electric Reliability Council of Texas, or ERCOT. The ERCOT grid “remains beyond the jurisdiction of the Federal Energy Regulatory Commission,” the federal entity that regulates the power grid for the rest of the nation. ERCOT took on additional power following the 1999 move to deregulate the energy economy in Texas, an effort to create a completely free market for electricity in the state to benefit both consumers and companies. This independence had most Texans’ ardent approval . . . until the cold front rolled in late February 2021, obstructing the flow of the state’s natural gas and leading to the failure of 356 electric generators state-wide. While other Southern states relied on the national power grid to maintain their electricity, Texas had no one but itself to fall back on, and was quite literally left out in the cold.

While some argue that the independent electrical grid was not to blame for Texas’s misfortunes, insisting that the cold temperatures in the rest of the nation meant there wouldn’t be much energy to spare anyway, it is undeniable that the deep freeze has called attention to many cons of Texas’s pro-deregulation energy market. Though there is what could be considered an “instinctive aversion to federal meddling” in avoiding federal regulation, as well as sensible reasons for a state of Texas’s size and natural resources to remain separate from the other 47 continental United States, the reality remains that many Texans suffered at the hands of its own power grid. As the bills pile up and Texans increase the water bottles they have in their pantry at any given time, one can see how some might favor the security of a more regulated system over the freedom that lead to surge pricing, dry faucets, and dark homes.  However, as with all government regulation, there is a price to pay, and perhaps the Lone Star State prefers to stay “lone” for that very reason. Either way, Texas, now warmer and well-lit, is no doubt grateful to return to our 2021 definition of “normal” and hoping that their lives stop sounding like a verse of a beloved Bill Joel song (no, not Piano Man).


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

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

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.


Becoming “[COVID]aware” of the Debate Around Contact Tracing Apps

Ellie Soskin, MJLST Staffer

As COVID-19 cases continue to surge, states have ramped up containment efforts in the form of mask mandates, business closures, and other public health interventions. Contact tracing is a vital part of those efforts: health officials identify those who have been in close contact with individuals diagnosed with COVID-19 and alert them of their potential exposure to the virus, while withholding identifying information. But traditional contact tracing for a true global pandemic requires a lot of resources. Accordingly, a number of regions have looked to smartphone-based exposure notification technology as an innovative way to both supplement and automate containment efforts.

Minnesota is one of the latest states to adopt this approach: on November 23rd, the state released “COVIDaware” a phone application designed to notify individuals if they’ve been exposed to someone diagnosed with COVID-19. Minnesota’s application utilizes a notification technology developed jointly by Apple and Google, joining sixteen other states and the District of Columbia, with more expected to roll out in the coming weeks. The nature of the technology raises a number of complex concerns over data protection and privacy. Additionally, these apps are more effective the more people use them and lingering questions remain as to compliance and the feasibility of mandating use.

The joint Apple/Google notification software used in Minnesota is designed with an emphasis on privacy. The software uses anonymous identifying numbers (“keys”) that change rapidly, does not solicit identifying information, does not provide access to GPS data, and only stores data locally on each user’s phone, rather than in a server. The keys are exchanged via localized Bluetooth connection operating in the background. It can also be turned off and relies wholly on self-reports. For Minnesota, accurate reports come in the form of state-issued verification codes provided with positive test results. The COVIDaware app checks daily to see if any keys contacted within the last 14 days have recorded positive test results. Minnesota policymakers, likely aware of the intense privacy concerns triggered by contact tracing apps, have emphasized the minimal data collection required by COVIDaware.

The data privacy regulatory scheme in the United States is incredibly complex, as there is no single unified federal data protection policy. Instead, the sphere is dominated by individual states. Federal law enters into the picture primarily via the Health Insurance Portability and Accountability Act (“HIPAA”), which does not apply to patients voluntarily giving health information to third parties. In response to concerns over contact tracing app data, multiple data privacy bills were introduced to Congress, but even the bipartisan “Exposure Notification Privacy Act” remains unpassed.

Given the decentralized nature of the internet, applications tend to be designed to comply with all 50 states’ policies. However, in this case, state-created contact tracing applications are designed for local use, so from a practical perspective states may only have to worry about compliance with neighboring states’ data privacy acts. The Minnesota Government Data Practices Act passed in 1974 is the only substantive Minnesota state statute affecting data collection and neighboring states’ (Wisconsin, Iowa, North Dakota, and South Dakota) laws have similarly limited or dated schemes. In this specific case, the privacy-focused Apple/Google API that forms the backbone of COVIDaware and the design of the app itself, described briefly above, likely keep it complaint. In fact, some states have expressed frustration at the degree of individual privacy afforded by the Apple/Google API, saying it can stymie coordinated public health efforts.

Of course, one solution to even minimal data privacy concerns is simply not to use the application. But the efficacy of contact tracing apps depends entirely on whether people actually download and use them. Some countries have opted for degrees of mandatory use: China has mandated adoption of its contact tracing app for every citizen, utilizing unprecedented government surveillance to flag individuals potentially exposed, and India has made employers responsible for ensuring every employee download its government-developed contact tracing app. While a similar employer-based approach is not legally impossible in the United States, any such mandate would be legally complex, and anyone following the controversy over mask mandates should instinctively recognize that a mandated government tracking app is a hard sell (to put it lightly).

But mandates may not even be necessary. Experts have emphasized that universal compliance isn’t necessary for an app to be effective: every user helps. Germany and Ireland have not mandated use, but have download rates of 20% and 37% respectively. Some have proposed small, community-focused launches of tracking apps, similar to successful start-ups. With proper marketing and transparency, states need not even enter the sticky legal mess that is mandating compliance.

Virtually every policy response to COVID in the United States has been met with heated controversy and tracking apps are no different. As these apps are in their infancy, legal challenges have yet to emerge, but the area in general is something of a minefield. The limited and voluntary nature of Minnesota’s COVIDaware app likely places it out of the realm of significant legal challenges and significant data privacy concerns, at least for the moment. The general conversation around contact tracing apps is a much larger one, however, and has helped put data privacy and end user control into the global conversation.