Public Health

FDA Approval of a SARS-CoV-2 Vaccine and Surrogate Endpoints

Daniel Walsh, Ph.D, MJLST Staffer

The emergence of the SARS-CoV-2 virus has thrown the world into chaos, taking the lives of more than a million worldwide to date. Infection with SARS-CoV-2 causes the disease COVID-19, which can have severe health consequences even for those that do not succumb. An unprecedented number of vaccines are under development to address this challenge. The goal for any vaccine is sterilizing immunity, which means viral infection is outright prevented. However, a vaccine that provides only partially protective immunity will still be a useful tool in fighting the virus. Either outcome would reduce the ability of the virus to spread, and hopefully reduce the incidence of severe disease in those who catch the virus. An effective vaccine is our best shot at ending the pandemic quickly.

For any vaccine to become widely available in the United States, it must first gain approval from the Food and Drug Administration (FDA). Under normal circumstances a sponsor (drug manufacturer) seeking regulatory approval would submit an Investigational New Drug (IND) application, perform clinical trials to gather data on safety and efficacy, and finally file a Biologics License Application (BLA) if the trials were successful. The FDA will review the clinical trial data and make a determination as to whether the benefits of the therapy outweigh the risks, and if appropriate, approve the BLA. Of course, degree of morbidity and mortality being caused by COVID-19 places regulators in a challenging position. If certain prerequisites are met, the FDA as the authority to approve a vaccine using an Emergency Use Authorization (EUA). As pertaining to safety and efficacy, the statutory requirements for issuing an EUA are lower than normal approval. It should also be noted that an initial approval via EUA does not preclude eventual normal approval.  Full approval of the antiviral drug remdisivir is an example of this occurrence.

In any specific instance, the FDA must conclude that a reason for using the EUA process (in this case SARS-CoV-2):

can cause a serious or life-threatening disease or condition . . . based on the totality of scientific evidence available . . . including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that . . . the product may be effective in diagnosing, treating, or preventing [SARS-CoV-2] . . . the known and potential benefits of the product, when used to diagnose, prevent, or treat [SARS-CoV-2], outweigh the known and potential risks of the product . . . .

21 USC 360bbb-3(c). On its face, this statute does not require the FDA to adhere to the full phased clinical trial protocol in grating an EUA approval. Of course, the FDA is free to ask for more than the bare minimum, and it has wisely done so by issuing a set of guidance documents in June and October. The FDA indicated that, at the minimum, a sponsor would need to supply an “interim analysis of a clinical endpoint from a phase 3 efficacy study;” that the vaccine should demonstrate an efficacy of at least 50% in a placebo controlled trial; that phase 1 and 2 safety data should be provided; and that the phase 3 data “should include a median follow-up duration of at least two months after completion of the full vaccination regimen” (among other requirements) in the October guidance.

It is clear from these requirements that the FDA is still requiring sponsors to undertake phase 1, 2, and 3 trials before FDA will consider issuing an EUA, but that the FDA is not going to wait for the trials to reach long term safety and efficacy endpoints, in an effort to get the public access to a vaccine in a reasonable time frame. The Moderna vaccine trial protocol, for example, has a study period of over two years. The FDA also has a statutory obligation to “efficiently review[] clinical research and take[] appropriate action . . . in a timely manner.” 21 USC § 393(b)(1).

One method of speeding up the FDA’s assessment of efficacy is a surrogate endpoint. Surrogate endpoints allow the FDA to look at an earlier, predictive metric of efficacy in a clinical trial when it would be impractical or unethical to follow the trial to its actual clinical endpoint. For example, we often use blood pressure as a surrogate endpoint when evaluating drugs intended to treat stroke. The FDA draws a distinction between candidate, reasonably likely, and validated surrogate endpoints. The latter two can be used to expedite approval. However, in its June guidance, the FDA noted “[t]here are currently no accepted surrogate endpoints that are reasonably likely to predict clinical benefit of a COVID-19 vaccine . . . .  [and sponsors should therefore] pursue traditional approval via direct evidence of vaccine safety and efficacy . . . .” This makes it unlikely surrogate endpoints will play any role in the initial EUAs or BLAs for any SARS-CoV-2 vaccine.

However, as the science around the virus develops the FDA might adopt a surrogate endpoint as it has for many other infectious diseases. Looking through this list of surrogate endpoints, a trend is clear. For vaccines, the FDA has always used antibodies as a surrogate endpoint. However, the durability of the antibody response to SARS-CoV-2 has been an object of much concern. While this concern is likely somewhat overstated (it is normal for antibody levels to fall after an infection is cleared), there is evidence that T-cells are long lasting after infection with SARS-CoV-1, and likely play an important role in immunity to SARS-CoV-2. It is important to note that T-Cells (which coordinate the immune response and some of which can kill virally infected cells) and B-Cells (which produce antibody proteins) are both fundamental, and interdependent pieces of the immune system. With this in mind, when developing surrogate endpoints for SARS-CoV-2 the FDA should consider whether it is open to a more diverse set of surrogate endpoints in the future, and if so, the FDA should communicate this to sponsors so they can begin to build the infrastructure necessary to collect the data to ensure vaccines can be approved quickly.

 


It’s a Small World, and Getting Smaller: The Need for Global Health Security

Madeline Vavricek, MJLST Staffer

The word “unprecedented” has been used repeatedly by every news organization and government official throughout the last several months. Though the times that we live in may be unprecedented, they are far from being statistically impossible—or even statistically unlikely. Based on the most recent implementation of the International Health Regulations released by the World Health Organization (WHO) in 2005, more than 70% of the world is deemed unprepared to prevent, detect, and respond to a public health emergency. The reality of this statistic was evidenced by the widespread crisis of COVID-19. As of September 29, 2020, the global COVID-19 death toll passed one million lives, with many regions still reporting surging numbers of new infections. Experts caution that the actual figure could be up to 10 times higher.

The impact of COVID-19 has made pandemic preparedness paramount in a way modern times have yet to experience. While individual countries look inward towards their own national response to the coronavirus, it is apparent now more than ever that global issues demand global solutions. The ongoing COVID-19 pandemic indicates a need for increased resiliency in public health systems to manage infectious diseases, a factor known as global health security.

The Centers for Disease Control and Prevention (CDC) defines global health security as “the existence of strong and resilient public health systems that can prevent, detect, and respond to infectious disease threats, wherever they occur in the world.” Through global health security initiatives, organizations such as the Global Health Security Agenda focus on assisting individual countries in planning and resource utilization to address gaps in health security in order to benefit not only the health and welfare of the individual countries, but the health and welfare of the world’s population as a whole. The Coronavirus has been reported in 214 countries, illustrating that one country’s health security can impact the health security of dozens of others. With the ever-increasing spread of globalization, it is easier for infectious diseases to spread more than ever before, making global health security even more essential than in the past.

Global health security effects more than just health and pandemic preparedness worldwide. Johnson & Johnson Chief Executive Officer Alex Gorsky recently stated that “[g]oing forward, we’re going to understand much better that if we don’t have global public health security, we don’t have national security, we don’t have economic security and we will not have security of society.” As demonstrated by COVID-19, failure to adequately prevent, detect, and respond to infectious diseases has economic, financial, and societal impacts. Due to the Coronavirus, the Dow Jones Industrial Average and the Financial Times Stock Exchange Group saw their biggest quarterly drops in the first three months of the year since 1987; industries such as travel, oil, retail, and others have all taken a substantial hit in the wake of the pandemic. Unemployment rates have increased dramatically as employers are forced to lay off employees across the majority of industries, amounting in an estimated loss of 30 million positions in the United States alone. Furthermore, Coronavirus unemployment has been shown to disproportionally affect women workers and people of color. The social and societal effects of COVID-19 continue to emerge, including, but not limited to, the interruption of education for an estimated 87% of students worldwide and an increase in domestic violence rates during shelter in place procedures. The ripple effect caused by the spread of infectious disease permeates nearly every aspect of a nation’s operation and its people’s lives, well beyond that of health and physical well-being.

With a myriad of lessons to glean from the global experience of COVID-19, one lesson countries and their leaders must focus on is the future of global health security. The shared responsibility of global health security requires global participation to strengthen health both at home and abroad so that future infectious diseases do not have the devastating health, economic, and social consequences that the coronavirus continues to cause.

 


A Cold-Blooded Cure: How COVID-19 Could Decimate Already Fragile Shark Populations

Emily Kennedy, MJLST Staffer

Movies like Jaws, Deep Blue Sea, and The Meg demonstrate that fear of sharks is commonplace. In reality, shark attacks are rare, and such incidents have even decreased during the COVID-19 pandemic with fewer people enjoying the surf and sand. Despite their bad, Hollywood-driven reputation sharks play a vital role in the ocean ecosystem. Sharks are apex predators and regulate the ocean ecosystem by balancing the numbers and species of fish lower in the food chain. There are over 500 species of sharks in the world’s oceans and 143 of those species are threatened, meaning that they are listed as critically endangered, endangered, or vulnerable. Sharks are particularly vulnerable because they grow slowly, mature later than other species, and have relatively few offspring. Shark populations are already threatened by ocean fishing practices, climate change, ocean pollution, and the harvesting of sharks for their fins. Sharks now face a new human-imposed threat: COVID-19.

While sharks cannot contract the COVID-19 virus, the oil in their livers, known as squalene, is used in the manufacture of vaccines, including COVID-19 vaccines currently being developed. Shark squalene is harvested via a process known as “livering,” in which sharks are killed for their livers and thrown back into the ocean to die after having their livers removed. The shark squalene is used in adjuvants, ingredients in vaccines that prompt a stronger immune response, and has been used in U.S. flu vaccines since 2016. Approximately 3 million sharks are killed every year to supply squalene for vaccines and cosmetic products, and this number will only increase if a COVID-19 vaccine that uses shark squalene gains widespread use. One non-profit estimates that the demand for COVID-19 vaccines could result in the harvest of over half a million sharks.

Sharks, like many other marine species, are uniquely unprotected by the law. It is easier to protect stationary land animals using the laws of the countries in which their habitats are located. However, ocean habitats largely ungoverned by the laws of any one country. Further, migratory marine species such as sharks may travel through the waters of multiple countries. This makes it difficult to enact and enforce laws that adequately protect sharks. In the United States, the Lacey Act, the Endangered Species Act, and the Magnuson-Stevens Fishery Conservation and Management Act govern shark importation and harvesting practices. One area of shark conservation that has gotten attention in recent years is the removal of shark fins for foods that are considered delicacies in some countries. The Shark Conservation Act was passed in the United States in response to the crisis caused by shark finning practices, in addition to the laws that several states had in place banning the practice. The harvest of shark squalene has not garnered as much attention as of yet, and there are no United States laws enacted to specifically address livering.

Internationally, the Convention on the Conservation of Migratory Species of Wild Animals (CMS) and the International Plan of Action for the Conservation and Management of Sharks (IPOA) are voluntary, nonbinding programs. Many of the primary shark harvesting nations have not signed onto CMS. The Convention on International Trade in Endangered Species of Wild Flora and Fauna (CITES) is binding, but there are loopholes and only 13 shark species are listed. In addition to these international programs, some countries have voluntarily created shark sanctuaries.

Nations that have refused to agree to voluntary conservation efforts, that circumvent existing international regulations, and lack sanctuaries leave fragile shark species unprotected and under threat. The squalene harvesting industry in particular lacks transparency and adequate regulations, and reports indicate that protected and endangered shark species end up as collateral damage in the harvesting process. A wide array of regional and international interventions may be necessary to provide sharks with the conservation protections they so desperately need.

Research and development of medical cures and treatments for humans often comes with animal casualties, but research to development of the COVID-19 vaccine can be conducted in a way that minimizes those casualties. There is already some financial support for non-animal research approaches and squalene can also be derived and synthesized from non-animal sources. Shark Allies, the conservation group that created a Change.org petition that now has over 70,000 signatures, suggests that non-shark sources of squalene be used in the vaccine instead, such as yeast, bacteria, sugarcane, and olive oil. These non-animal adjuvant sources are more expensive and take longer to produce, but the future of our oceans may depend on such alternative methods that do not rely on “the overexploitation of a key component of the marine environment.”


COVID-19: Detrimental to Humans, Beneficial to the Environment?

Janae Aune, MJLST Staffer

No one is a stranger to the virus that has quickly changed life from recognizable to socially distanced and isolated. COVID-19, generally known as coronavirus, has gripped the world since the end of 2019 when it was first discovered. The virus has caused cities and countries to shut down, people to self-isolate, and Purrell to experience an increase in demand like never before. With so many negative consequences of the virus, are there are any possible positives that could come from this? Some argue yes –look at the environment.

COVID-19 Generally

Coronaviruses are not uncommon or unknown in the world. Every person has likely had one type of coronavirus in their life as these viruses are responsible for the common cold. The novel coronavirus currently gripping the world is not like other common coronaviruses’ however. The CDC has dubbed the disease COVID-19 because of the novelty and its discovery in 2019. Common symptoms of COVID-19 are fever, dry cough, and shortness of breath. Because these symptoms are similar to other coronaviruses and common allergies, many have experienced difficulty in properly detecting early COVID-19 symptoms. COVID-19 becomes even harder to accurately detect because some who have been infected or exposed to the disease are asymptomatic and may never know they had the virus.

COVID-19 was first discovered in Wuhan, China back in November 2019. Many other people recognize the area of discovery from the SARS outbreak back in the early 2000’s. Both of the diseases have been traced back to the wet markets in China housing wild animals being sold for food. For more information on the background of these markets in China see the short Vox documentary discussing these markets and the roots within Chinese society. While the first case was discovered in China, the disease has now spread across the world affecting every continent except Antarctica.

Spread of COVID-19

Much of the spread of COVID-19 around the world is  attributed to international travel. Since the discovery of the virus, many countries have gone on social distancing and lockdown orders to slow or prevent community spread of the disease. Even with these measures, some countries like the United States have yet to hit their peak number of cases. Countries like Spain and Italy have been hit the hardest in the European Union, however the situation is hoped to be improving soon. South Korea was hit particularly early, however given the government’s intense response with testing the country was relative successful in slowing the spread of the disease. The travel industry has taken a large hit from the disease with many not traveling and some countries shutting down airports and banning flights from certain areas of the world.

Within the United States in particular some states have yet to practice social distancing effectively. Big cities like New York City, Los Angeles, and Washington D.C. have been on shelter-in-place orders for multiple weeks with little sign they will end soon. New York City in particular has been hit hard with deaths increasing every day and hospitals becoming over capacity. This week (April 6, 2020) is expected to be the peak week of deaths, however some experts speculate the number will continue to grow after this week. Many have been critical of the response of the government in the United States in not taking the disease seriously when it was first discovered and properly preparing the country, while others have found the government’s response adequate.

Does the environment benefit from COVID-19?

COVID-19 has dramatically changed human life from what it was at the beginning of the year, and usually for the worst. COVID-19 has not only changed human life however. With most of the world being told to stay inside or practice social distance, environments, cities, and ecosystems around the world have experienced an abrupt departure from how life used to be. The canals of Venice have cleared up with fish returning. Goats have roamed back into cities in Europe where tourists usually dominate. City skylines previously blocked by smog are now clearly visible. Research shows the changes big cities have experienced due to the decrease in air travel with major cities like Los Angeles having dramatically different air pollution rates. Is it possible that COVID-19 will have a lasting positive impact for the environment? The answers are split.

In addition to these obvious positive impacts, some argue the benefits extend beyond the cosmetic. Lower levels of CO2 in the air can contribute to decreasing how often people experience diseases. Greenhouse gasses suppress the atmosphere and air around people and decreasing those levels can improve air quality and, in turn diminish how often people experience some diseases.

Even given the positive impacts, some worry the impact will only be temporary. UN officials argue exactly that. While the rebuilding efforts have not begun, one UN official argues once they do, sweeping environmental policy changes are needed in order to maintain the positive impact. Without these radically different policies, the positive impacts currently happening will be fleeting and unsustainable. Additionally, the official argues sweeping policy changes and increased spending for green energy and technology will lower the possibility of diseases spreading like this again in the future.

While some argue the deadly disease has created positive consequences for the environment, others feel very differently. Many states and countries have put their recycling programs on hold to contain the spread of the virus. Additionally, many retailers, grocery stores, gas stations, etc. have banned the use of reusable cups to eliminate the amount of potential contamination. This means more plastic, Styrofoam, etc. is being used on a daily basis around the world. Even online retailers have arguably contributed to the negative environmental causes by shipping more than usual due to people being at home and shipping things in multiple containers rather than consolidating into fewer boxed. Finally, many legislatures and governments have put serious climate legislation on the backburner to deal with the COVID 19 crisis. This could stall progress and cause delays in legislation and projects that had been started prior to the pandemic.

 


Boeing Bailout: 737 Max Crashes and the Coronavirus

Bernard Cryan, MJLST Staffer

Boeing Overview

Boeing plays a major role in the aerospace industry—both domestically and internationally. Boeing employs over 160,000 people worldwide and had a revenue of $76 billion in 2019. According to Forbes’ 2019 Fortune Global List, Boeing is ranked as Fortune 100 company. In fact, Boeing is America’s largest manufacturing exporter. Boeing’s business operations are organized into three units: Commercial Airplanes; Defense, Space & Security; and Boeing Global Services. Boeing’s Commercial Airplanes division is responsible for producing “almost half the world fleet” with more than 10,000 Boeing-built jetliners in service worldwide and “about 90% of the world’s cargo is carried onboard Boeing planes.”

737 Max Crashes

Boeing’s popular commercial airplane—the 737 Max—was recently involved in two deadly crashes. In October 2018, 189 passengers were killed on a Lion Air flight taking off from Indonesia. Again, in March 2019, 157 passengers were killed on an Ethiopian Airlines flight just minutes after takeoff. In response, Boeing grounded all 737 Max airplanes around the world and created a $100 million relief fund “to meet the family and community needs of those affected by the accidents.” Nevertheless, Boeing has received harsh criticism and scrutiny over deficiencies in its product and training. The 737 Max airplanes are still not cleared to fly causing Boeing customers to revise or even cancel orders. Certain airlines have also demanded compensation from Boeing for flight cancellations that resulted from the grounding of 737 Max airplanes. Boeing’s stock price fell after the crashes and Boeing’s revenue fell from $101 billion in 2018 to $76 billion in 2019. Boeing even replaced its CEO after he was unable to stabilize the company following the crashes. In sum, the 737 Max crashes have forced Boeing into a vulnerable financial position.

Coronavirus

The recent COVID-19 outbreak has posed additional challenges for Boeing and the entire aerospace industry. Boeing has publicly acknowledged the struggles of the entire industry caused by the coronavirus. For example, coronavirus’ impact on travel has forced American Airlines to fly its first cargo-only flight in 36 years. Boeing is directly impacted by the coronavirus because struggling airlines are not currently in the position to place orders for new airplanes.

Government’s Response

Although there is fierce competition amongst airlines, there is little competition in the manufacture of commercial airplanes. Boeing and Airbus, a European company, are the two main global suppliers of large commercial aircraft and have almost complete market power. President Trump has recognized Boeing’s indispensable role in keeping America competitive in the global industry and has recently stated, “Yes, I think we have to protect Boeing. We have to absolutely help Boeing.” Boeing has publicly expressed support for the government’s plan to bailout the aerospace industry.

Boeing is requesting a bailout of the aerospace industry in the amount of $60 billion. Boeing has suspended paying dividends and CEO Dave Calhoun has given up his pay temporarily. Additionally, United Airlines has threatened to cut jobs if the bailout relief is not passed by Congress. The aerospace industry wants help from the government. Some, however, caution against using the term ‘bailout’ for this type of situation because the airlines did not cause the hardship resulting from the coronavirus. Although Boeing and the airlines are not responsible for the coronavirus, they are at least partly responsible for their current inability to survive through these challenging times—Boeing and the airlines have spent billions of dollars in recent years buying back their own stock. For example, airlines have spent $42.5 billion on buy backs between 2014 and 2019 which is almost identical to the amount the industry is now requesting from the government.

The Bailout and The Takeaway

A government bailout can be in the form of legislation providing money or resources to a company or even an industry to help that company or industry avoid bankruptcy. For example, Congress approved a $15 billion bailout to the airlines in response to the 9/11 terrorist attacks. Another example is the Emergency Economic Stabilization Act of 2008 where the government provided bailout relief to banks after the mortgage crisis. AIG initially received an $85 billion loan (later receiving more money totaling $150 billion) from the Treasury in exchange for 79.9% equity in AIG. The loan was to be repaid with interest; the U.S. government and taxpayers eventually made $22.7 billion from interest payments.

A government bailout of the aerospace industry appears imminent. Boeing is likely to be considered “too big to fail.” The main questions are how much money will go to Boeing and the aerospace industry, in what form, e.g., debt or equity, and what strings will be attached to that money. Will the government acquire some ownership of Boeing as they did with AIG? Boeing CEO has said Boeing may reject any relief from the government if the government demands stake in the company. Will Boeing be required to change any of its Commercial Airplane division business practices? Will there be more government oversight of Boeing’s operations? Will Boeing be required to cut emissions from its planes to help protect the environment? The aerospace industry bailout will be interesting to monitor as things should come together quickly in the next few weeks, or even days.


Can the Legal System Help Combat COVID-19

Amanda Jackson, MJLST Staffer

As the novel coronavirus, COVID-19, continues its global rampage, the United States has been hard hit.  Now third with respect to number of new cases, there is little evidence to show that the case count will decrease any time soon.  If Italy provides any indication of what is to come, the United States is only going to be hit harder by the life-threatening virus.  Both federal government and local governments have taken drastic measures to combat the spread of COVID-19, including state-wide shelter-in-place orders, closing schools and universities, banning dining in at bars and restaurants, and moving non-essential businesses to work-from-home models.

As the confirmed cases continue to rise, so does uncertainty and uneasiness among the nation and the world as a whole.  What will fix this crisis?  How long will these measures be in place?  How many more people will get sick and potentially pass away from the virus?  What will happen to the economy?  Will my loved ones be okay?  The questions never seem to end.  Luckily, however, there are some answers as to how different laws, administrative agencies, and regulations in place in the United States can aid in the fight against the quickly spreading coronavirus.

First, the Defense Production Act (DPA) can alleviate shortages in medical equipment.  As concern about the novel virus itself grows, concern for the availability of necessary supplies and equipment also seems to grow at record speeds.  A lack of masks and other personal protective equipment for healthcare workers, a shortage in ventilators and beds for sick patients, and even a need for healthcare workers and hospital space are becoming more prevalent as the COVID-19 crisis continues.   The DPA, a Korean War-era law, enables the federal government to require private companies to provide for the needs of national defense.  The DPA may not be able to satisfy the need for healthcare workers and hospital space, but it can allow the federal government to direct manufacturers to produce the desperately needed medical equipment for healthcare workers and patients.  However, the President must invoke the DPA in order for it to make a difference, and as of right now, the DPA has not been invoked to aid in the fight against coronavirus.  Although some companies have increased or altered production to help restock the necessary equipment, it remains unclear whether that alone, without invoking the DPA, will be enough to meet the needs of the United States in the coming weeks.  Even so, the DPA provides a robust option to fulfill the needs of the nation in the fight against the pandemic.

Second, the Federal Drug Administration’s (FDA) and the National Institute of Health’s (NIH) ability to fast track vaccines and therapeutic drugs can speed up development of a COVID-19 vaccine or therapy.  Called an Emergency Use Authorization (EUA), the FDA is able to authorize emergency use of an unapproved product or an unapproved use of an approved product under a declaration of a public health, domestic, or military emergency, or a material threat.  The evidence required for approval of an EUA is that the product “may be effective” to treat, diagnose, or prevent the conditions associated with the declaration.  This is a lower standard than the “effectiveness” standard used for typical FDA approvals, a process that takes on average twelve years to go from a new drug in a laboratory to a drug on a pharmacy shelf.  In determining whether to approve the EUA, the Commissioner has to determine that the known and potential benefits of the product outweigh the risks associated with the product, while also considering the threat prompting the emergency declaration.  Fortunately, the FDA has already issued multiple EUAs with respect to the novel coronavirus, such as for tests to detect COVID-19.  The FDA has also instituted flexible measures outside of EUAs that enable states to take a more prominent role than typically allowed.  For example, the FDA is now allowing states to approve COVID-19 tests without requiring FDA approval or an EUA.  Moreover, NIH is also fast-tracking development of a coronavirus vaccine, with a Phase I clinical trial of the vaccine candidate having already begun.

Third, declarations of major disaster areas will open up emergency funds to help states and local governments respond to an outbreak.  Major disaster area declarations are often requested when a disaster exceeds the response capabilities of state and local governments under extremely severe circumstances.  Major disaster area declarations enable a wide range of federal assistance for both individuals and public infrastructure.  With respect to coronavirus, the President has already declared New York and other hard-hit states as major disaster areas, the first time in United States history that a major disaster has been declared for a public health threat.  The declaration enables the federal government to pay for a majority of the states’ costs and mobilize the Federal Emergency Management Agency (FEMA) to deploy assistance in the state, among other methods of assistance.

Fourth, shelter-in-place orders by local governments may reduce the spread of the virus.  Shelter-in-place orders mandate that residents stay in their homes, except for essential trips (e.g., to the grocery store or a pharmacy).  Many shelter-in-place orders also force all non-essential businesses to close.  These orders are generally constitutional under a state’s police power.  At least eight states and many cities have issued shelter-in-place orders as a means to flatten the curve and reduce the impact of coronavirus on society and the healthcare system.  Some law enforcement officials appear to be taking the orders very seriously, breaking up parties in violation of the shelter-in-place rules or stating that the orders will be “strictly enforced.”

Moreover, there are multiple bills working their way through the federal government that will hopefully provide some more answers and relief for the American people.  Although those options are only a few of the tools in the government’s toolbox, if used properly, they can help the nation combat COVID-19.


Foodborne Illness Law: E. coli, Salmonella, and More

Katherine Nixon, MJLST Staffer

Sometime in the fall of 2018, I walked into Chipotle hoping for a nice savory burrito bowl. The best burrito bowl—at least in my opinion—is made up of the following: brown rice, chicken, cheese, lettuce, hot salsa, sour cream, and guacamole. One ingredient missing can throw off the whole experience. Well, I walked into Chipotle only to find a printed sign on the glass in front of the various ingredients. Let’s be honest, that never means anything good. The sign notified customers that Chipotle would not currently be offering romaine lettuce due to an E. coli outbreak. At first, all I could think was “Noooo, not my beloved burrito bowl. What will it be like without the crunchy lettuce?”

In looking past my immediate concern over the negative effect that a lettuceless burrito bowl would have on my taste buds, I was ultimately thankful I had not eaten the romaine lettuce. Big picture things. It was discovered that the romaine lettuce came from a farm in Santa Barbara County, California. It was distributed through many avenues and not just to food establishments like Chipotle. Unfortunately, people became very sick. According to the Center for Disease Control and Prevention (CDC), 62 people were infected from 16 states and the District of Columbia. Further, 25 people were hospitalized and 2 people developed a form of kidney failure. This ended up being a big deal. That particular outbreak began in October 2018 and wasn’t declared over until January 9, 2019.

Believe it or not, E. coli outbreaks occur with some frequency. A massive outbreak that began in September 2019 was just declared over by the CDC on January 15, 2020. Again, the source of that outbreak was romaine lettuce. Other outbreaks in 2019 came from ground bison, flour, and ground beef. Aside from E. coli, there are other types of outbreaks as well. For instance, in 2019, there were several Salmonella outbreaks related to food items such as papayas and frozen raw tuna. Many people fell sick.

At this point, you might be wondering—what does this all have to do with law? It turns out there is a whole body of law generally referred to as “foodborne illness law.” I know—you definitely don’t learn about that in your normal law school curriculum. Yet, the name is somewhat self-explanatory. As succinctly put by the Public Health Law Center at Mitchell Hamline School of Law, “[A] person who is injured as a result of a foodborne illness may bring a civil cause of action against another by claiming that the other individual is legally liable for the harm caused by the foodborne illness.” Sometimes, there is even strict liability.

Overall, this type of law can be highly technical and usually involves the help of experts. It also can be quite difficult. Including the difficulty that often comes in discovering the source of a certain outbreak as well as the manufacturer of that source. It can be like piecing a giant puzzle together. However, once the pieces start to fit together, it all begins to make sense. If you have a science background, especially biology, this may be an area of law for you to consider. Next time you are at a family gathering and Uncle Eddy asks what you want to do, tell him you want to specialize in foodborne illness law. That will surely grab his attention.

 

 


“Juuling”: Gen Z’s Alleged Addiction May Mean Major Legal Problems for E-Cigarette Companies

By: Jack Kall, Minnesota Journal of Law, Science & Technology Vol. 20 Staffer

With every new week comes new headlines regarding Gen Z and their latest craze. After years of Millennials being cast as the generation responsible for everything wrong in the world, (Business Insider’s list of 19 things Millennials are killing, including everything from homeownership, banks, football, and oil to beer, napkins, cereal, and bars of soap; NPR describing how Millennials are killing Applebee’s; Forbes claiming Millennials might kill home-cooked meals and kitchens) it seems the media has found a new culprit, Gen Z! Gen Z’s supposed addiction to e-cigarettes, specifically to the JUUL brand, is common among the headlines.

Depending on how you define the generation, Gen Z includes anyone born in the years starting with 1995–2000 and ending between 2014–25. Pew Research has yet to name or define the end date of Gen Z, but it defines the “Post-Millennial generation” as those born 1997 and later.

No matter how you define Gen Z, it includes high school students, many of whom are under the legal tobacco consumption age of 18. High schoolers have been a major reason for both the rise of e-cig popularity and for giving JUUL Labs major market share in the e-cig industry. Browse through social media pages popular within the Gen Z community and you’ll inevitably see numerous posts about “Juuling.” However, Gen Z isn’t alone in its supposed obsession with e-cigs, as Leonardo DiCaprio (a member of Gen X) has long been known to appreciate vaping (e.g., 1, 2, 3).

JUUL Labs, which launched in 2015, has been repeatedly investigated for targeting minors through its advertising and sued for targeting teens with false claims of product safety. In 2017, Consumer Reports found that teens who vape are seven times more likely to turn to regular cigarettes. Additionally, the CDC has declared e-cig use among young people a public health concern.

As further research is published, JUUL should expect be the main target of continued legal action. One current case, a nationwide class action with ten named plaintiffs aged above 13, alleges in part that JUUL’s decision to market through social media was aimed at soliciting those under the legal smoking age. Another case, filed on behalf of a high school sophomore, alleges that JUUL is commonplace among his school, including use “on the school bus, in the bathrooms, outside of school and even in class.”

JUUL Labs will hope to continue to have success while under major legal scrutiny for its marketing practices. JUUL, importantly, hopes it can continue to show growth following its impressive financial valuation (most recently raising $1.2 billion in a financing round that valued the company at over $15 billion).


Congress, Google Clash Over Sex-Trafficking Liability Law

Samuel Louwagie, MJLST Staffer

Should web companies be held liable when users engage in criminal sex trafficking on the platforms they provide? Members of both political parties in Congress are pushing to make the answer to that question yes, over the opposition of tech giants like Google.

The Communications Decency Act was enacted in 1934. In the early 1990s, as the Internet went live, Congress added Section 230 to the act. That provision protected providers of web platforms from civil liability for content posted by users of those platforms. The act states that in order to “promote the continued development of the internet . . . No provider of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.” That protection, according to the ACLU, “defines Internet culture as we know it.”  

Earlier this month, Congress debated an amendment to Section 230 called the Stop Enabling Sex Traffickers Act of 2017. The act would remove that protection from web platforms that knowingly allow sex trafficking to take place. The proposal comes after the First Circuit Court of Appeals held in March of 2016 that even though Backpage.com played a role in trafficking underage girls, section 230 protected it from liability. Sen. Rob Portman, a co-sponsor of the bill, wrote that it is Congress’ “responsibility to change this law” while “women and children have . . . their most basic rights stripped from them.” And even some tech companies, such as Oracle, have supported the bill.

Google, meanwhile, has resisted such emotional pleas. Its lobbyists have argued that Backpage.com could be criminally prosecuted, and that to remove core protections from internet companies will damage the free nature of the web. Critics, such as New York Times columnist Nicholas Kristof, argue the Stop Enabling Sex Traffickers Act was crafted “exceedingly narrowly to target those intentionally engaged in trafficking children.”

The bill has bipartisan support and appears to be gaining steam. The Internet Association, a trade group including Google and Facebook, expressed a willingness at a Congressional hearing to supporting “targeted amendments” to the Communications Decency Act. Whether Google likes it or not, eventually platforms will be at legal risk if they don’t police their content for sex trafficking.


Would Monetary Compensation Incentivize You to Register as an Organ Donor?

Na An, MJLST Article Editor

In the United States, the number of patients on the waitlist for receiving organ donations is much greater than the limited number of supplies.  One person is added to the list every 10 minutes, while only 3 in 1,000 people die in a way that allows for organ donation.  As deceased individuals constitute about two thirds of organ donors, 22 patients die waiting for a transplant every day.  The organ shortage also devastates the qualify of life for more than 100,000 people, and costs national economy tens of billions of dollars every year.  It incentivizes international organized black markets and human trafficking.  The organ shortage has multiple reasons, chief among which is people’s unwillingness to register as donors.  Study has shown that 95% of U.S. adults support organ donation; yet, only 48% of them actually signed up as donors.  Additionally, hospital procedures and customs often allow a family’s objection to undermine the wish of an intended donor.

Currently, the organ donation system is regulated by state law, federal law, government agencies, and hospital procedures.  Each state maintains its own donor registry, mostly linked to the driver’s licensing process, and state laws vary in their donation education program.  The National Organ Transplant Act (Act) instituted the Organ Procurement and Transplantation Network (OPTN) to match donated organs with recipients on the waitlist.  The Act also prohibits the sale of organs.  While the legislatures and courts remain silent, hospital procedures dictate.  For example, hospitals will almost never retrieve organs without the family consent even when doing so would be against the wish of the deceased.  Complicating the issue further is the inherent human rights of the donor, his/her family, and the recipient.

Confronting these issues, Stephanie Zwerner, in her article “A Small Price to Pay: Incentivizing Cadaveric Organ Donation with Posthumous Payments,” proposed a national donor registry and incentivization system.  First, a national donor registry will replace state registries, and eliminate the interstate discrepancies and inefficiencies.  The national registry can be consolidated with OPTN for effective administration.  To improve the validity of donor intent documentation, the article proposed donor registration through health insurance application, registration to vote, or income tax reporting.  Unlike “check-the-box” in driver licensing, everyone will be given a chance to fully consider their decisions.  Families and hospitals would be more willing to respect the wishes of intended donors.

To further incentivize registration, the article proposed a single lump sum payment to the donor’s estate financed by the recipient’s health insurance provider upon the event of an executed cadaveric organ donation.  Monetary compensation for organ donation has been a controversial topic.  Not only it is illegal under federal statute, it has also been considered as the “commodification of human body parts” and an intrinsic evil.  It decreases respect for life and human body, and can lead to exploitation of people in dire economic circumstances.  Acknowledging these negative consequences, the author presented several benefits: increasing donations while decreasing familial objections, saving lives, relieving people on the waitlist for many years of suffering, reducing black markets and the economic burden on national economy.  Considering that one donor could potential save eight lives, the article argues that the benefits outweigh the negative implications.