2021

You Can Design Your Clothes, but Can You “Design” a Baby? Ethical Objections to Genetic Modification of Embryos and the Prevention of Diseases in the Unborn

November 22, 2021
Uncategorized

Zanna Tennant, MJLST Staffer

The term “designer babies” has been thrown around quite a bit by those who find the genetic modification of babies to be morally repugnant. However, these fears are often blown out of proportion considering the benefits that such genetic testing and modification can give to babies in utero. The age-old debate of science versus religion is evident here, as scientists argue that genetic alteration can save lives while many with religious or spiritual backgrounds fear the ethical implications. How the world and the law should react to this newer science is still very much a controversial topic. Many countries have banned genetic modification of embryos altogether, while some are still unsure how to proceed. Despite these fears, genetic alteration should not be completely abandoned. It has the potential to prevent genes for diseases from passing from parent to child and save lives. It should not, however, be completely unregulated. While it is difficult to say precisely how to regulate and who should be in charge of such regulations, this is something that governments and the world as a whole must decide. This is exactly the challenge genetic testing faces today, especially from those who oppose it on religious or ethical grounds.

Women or others who may be having trouble conceiving or are concerned about possible hereditary diseases are among those likely to pursue in-vitro fertilization, a process by which a sperm and an egg are combined in a lab. This process results in an embryo. “Designer babies” are babies that come from embryos created by in-vitro fertilization (IVF) and are specifically selected because of the presence of “good” genes like intelligence, or the absence of “bad” genes, such as BRCA 1.  The genes of the embryos are then altered through the process of heritable genome altering, whereby scientists alter the DNA of the egg, sperm or any other cells involved in the process in order to achieve a desired result.For example, suppose an embryo has the gene for sickle cell anemia. Diseases often show up in DNA in the form of a genetic alteration, such as the presence of an extra chromosome or the absence of one. The embryo in this example would be taken to a lab where a scientist could alter it to get rid of the gene for sickle cell anemia. Heritable genome altering could prevent life-altering disabilities and diseases in children who otherwise may not survive.

Despite the enormous lifesaving potential, there is a large movement against genetic alteration of embryos. One of the biggest challenges genetic alteration faces is whether it is ethical to alter the genes of an unborn child. Many fear that this genetic alteration would be used to change what they consider to be superficial genes, such as hair or eye color. They think this is man’s way of “playing God” and is unnatural. Factors such as religion and spirituality heavily influence what people think about gene altering of babies. Some see the altering of embryos as going against God’s wishes.  Along with this issue, people who believe that life begins at conception are concerned with the rights of the embryos. Similar to the controversial topics of reproductive rights and abortion, there are those who think that altering the genes of an embryo violates the human rights of what they perceive to be a living child. They see the embryo as already being alive and having the same rights as any post-birth child. On the other side, there are those, including many scientists, who do not conflate the embryo with a human child and find their beliefs in line with those who support the right to choose. People are also concerned about the unknown effects of gene alteration since it is a more recent development and scientists believe that the genetic alerting of DNA might affect future generations in unknown ways. There is also concern about increasing socio-economic inequality due to the high price tag that comes with genetic alteration. In vitro fertilization on its own is expensive, but genetic alteration is upwards of $500,000. Should this technology become available to the public, only the very wealthy would be able to afford it, thereby increasing the divide between the rich and the poor.  Because of the controversy surrounding heritable genome altering, legal systems in different countries are often unsure what to do.

Some forty countries, such as China and Japan , have completely banned heritable genetic altering. In 2019, a biophysicist in China was criminally charged with illegal medical practice and sentenced to three years in prison after he edited genes of two embryos which later became baby girls. He used a new tool, CRISPR, which allows scientists to more easily edit genes and DNA. He was universally condemned, save for the scientific community. There are other countries, however, that have not banned heritable genome altering. Rather, they have placed strict regulations on how it is to be used. In the United Kingdom, they have banned all forms of genetic alteration except for the modifications of nuclear mitochondrial DNA, which are heavily regulated. Mitochondrial DNA testing focuses on diseases in the mitochondria of a cell that can be passed down from mother to child. This testing allows potential families to determine if the mitochondria in the embryo has a disease and allows them to replace the defective part of the mitochondria with a healthy part. Clinical trials for mitochondrial replacement therapy are allowed in the UK, but they are only allowed for medical purposes. Similarly, mitochondrial replacement therapy is offered on a case by case basis only to those who meet the necessary medical criteria. Even in the few countries which have not outright banned genetic alteration, there is still strict regulation and strong public criticism.

As in the rest of the world, genome editing is controversial in the United States. Although it is not technically illegal, it is regulated under the FDA and the National Health Institute. Any genetic testing must be approved by the FDA, which is no easy task. Generally, the editing of somatic cells is allowed, while the editing of germline cells is still very much up for debate. Somatic cells are those cells which have already been differentiated as blood cells or liver cells, while germline cells are those in the egg, sperm, or embryo. Alerting somatic cells is akin to altering the function of cells. Germline editing, on the other hand, is the controversial case of actually altering the genes that determine who a person is. There are clinical trials that have been approved for the use of CRISPR in somatic cell editing.  Recently, the FDA stated that the use of federal money cannot be used to research germline editing, but it can go towards funding for somatic cell editing. While the US has yet to actually ban germline editing, there is essentially a moratorium on its use as it is disfavored by many government officials. However, the US does permit the use of preimplantation genetic screening (or diagnosis), which is either heavily regulated or banned in other countries. Preimplantation genetic screening is a process used to test embryos for genetic abnormalities that could indicate a disease and help parents to find a healthy embryo to use. It is used in the course of IVF and can help parents to increase the likelihood that their child will make it to term and be healthy. PGS raises similar ethical concerns to genetic alteration due to its focus on finding the best embryo and using science to change DNA, which is why it is banned in some countries.

Despite the numerous, and admittedly (mostly) valid concerns, it would be contrary to human progress to completely rule out heritable genome testing. This process can save the lives of thousands of children yet to be born and could even erase a disease from a family’s hereditary line. Although there are certain inherent risks, the only way for the world to move forward with this achievement is to allow, within reason, clinical trials to take place so that scientists can better understand how best to alter genes. The federal government should, with regulations enacted, encourage the use of gene altering. Although states have admittedly said very little about gene editing, they, too, should support its use. Only through controlled, regulated tests can the best practices and the unknown consequences of gene editing be discovered. The focus of gene editing should be on how it can progress the medical field. People’s fear that gene editing will be used for superficial purposes is unfounded, scientists claim, as there is not a one for one ratio between a gene and, say, the trait for blue eyes. Scientists can better predict hair or eye color, but they cannot determine these traits with one hundred percent certainty, nor can they easily find and gene and determine that it is the gene for intelligence.The government could also easily limit gene editing for health reasons and medical research, thereby making this fear irrelevant. The US government, unlike other countries, has yet to really take a stand one way or the other when it comes to gene editing. It is time that the federal government get behind this scientific wave that could potentially erase diseases altogether from the human population.

Relieving a Pain Management Crisis: How Medical Cannabis May Help the Prescription Opioid Epidemic

November 13, 2021
Drug Policy, FDA, Food and Drug Law, Uncategorized

David C. Edholm, MJLST Staffer

“The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human . . . drugs.” To no surprise, near the top of the FDA’s list of current priorities is ameliorating the prescription opioid epidemic. More than 14,000 deaths in 2019 are attributed to prescription opioid overdoses. (See fig. 4 of hyperlink). Celebrity opioid overdoses have raised public awareness of the crisis, however, hundreds of millions of opioid prescriptions are written each year to treat “moderate-to-severe” pain. The epidemic continues today, begging the question of whether any reasonable alternatives to prescription opioids exist, perhaps medical cannabis.

California became the first state to legalize medical cannabis through a ballot initiative in 1996; since then, 35 states and four territories followed. Although the Department of Health and Human Services and the FDA have expressed skepticism about safety and efficacy due to a lack of quality research, legalization in a recreational capacity is becoming more popularized. Recent systematic studies on high-potency cannabis products have shown a cause for concern, however, studies on substituting medical cannabis for prescription opioids remain inconclusive, leaving the door open to this future possibility.

In order for medical cannabis to legitimately contend with prescription opioids, quality safety and efficacy data are required. But the public stands by as FDA has yet to approve a medical use and “marihuana” remains a Schedule I controlled substance. 18 U.S.C. § 812(1) (2018). Recent federal efforts push for decriminalization, but historically the federal government has adopted a “hands off” approach, giving states choice on cannabis regulation. There is coast-to-coast differentiation on cannabis legalization with most states permitting medical use and a growing number permitting recreational use, but due to its current state of being under-researched, it is substantially less controversial to leave the political choice for legalization to the states as long as safety and efficacy are opaque.

The benefit of state choice is articulated through efforts from states like California and Minnesota that aid the national effort to clarify safety and efficacy in legitimate ways. California, for example, allows medical and recreational use, as a result providing a vast data cohort. The state senate bill reads, “[i]t is the intent of the legislature that the state commission objective scientific research by . . . the University of California, regarding the safety and efficacy of administering cannabis as part of medical treatment.” Additionally, Minnesota, which permits medical use and submitted a bill for recreational approval now pending in the senate, created a medical cannabis patient registry that accumulates data, generates reports, and submits the reports to legislature and prominent medical journals that are available to the public. These states are among others providing similar efforts.

Medical cannabis may be an alternative for prescription opioids, yet there remain several questions about safety and efficacy that must be answered in order for the FDA to move on any milestone cannabis regulation. It seems that severe risks posed by cannabis are extremely rare, and are not a public health threat requiring immediate attention. Prescription opioids remain standard treatment post-operation or post-physical trauma and are usually prescribed for short-term use, but 20% of post-op patients still use opioids three months after surgery, despite an increased risk of addiction after only a few days of use. It seems the opioid epidemic is here to stay as long as prescribing practices remain the same, at least until an effective alternative arises. Maybe cannabis will be a solution. It depends on the data.

Counter Logic Broadband

November 13, 2021
Economics, Internet

Justice C. Shannon, MJLST Staffer

In 2015 Zaqueri “Aphromoo” Black won his first North American League of Legends championship series “LCS” championship playing support for Counter Logic Gaming. Since 2013 at least forty players have made the starting lineups for eight to ten LCS teams. Aphromoo is the only African American to win an LCS MVP. Aphromoo is the only African American player to win multiple LCS finals. Aphromoo is the only African American player to win a single LCS Final. Aphromoo is the only African American player to make it to an LCS final. Aphromoo is the only African American player to participate in LCS playoffs. Indeed, Aphromoo is the only African American player to have a starting role on an LCS team. Why? At least in part, because due to the digital divide.

More than a quarter of African Americans do not have broadband. Further, nearly 40% of the African Americans in the rural south do not have broadband. One quarter of the Latinx population does not have broadband. These discrepancies allow fewer African Americans and Latinx to play online video games like League of Legends. Okay, but if the digital divide only affects esports, why should the nation care? The digital divide, as seen in esports, is also seen in the American educational system. More than 15% of American households lacked broadband at the start of the pandemic. This gap was more pronounced in African American and Latinx households. These statistics demonstrate a national need to address the digital divide for entertainment purposes and, more importantly, educational purposes. So, what are some legal solutions to the digital divide? Municipal internet, subsidies, and low-income broadband laws.

Municipal Internet

Municipal broadband is not a new concept, but recently it has been seen as a solution to help address the digital divide. While the up-front cost to a city may be substantial, the long-term advantages can be significant. Highland, IL, and other communities across the United States provide high-speed internet for as low as $35 a month. Cities providing low-cost broadband through municipalities frequently have competitive prices for gigabit speeds as well. The most significant downside to this solution is that these cities are frequently in rural locations that do not provide for large populations. In addition, when municipalities attempt to provide broadband outside of their borders, state laws preempt them to protect ISPs. ISPs lobby for laws to deter or prevent municipal internet on the basis that they are necessary to prevent unfair competition; this fear of unfair competition, however, restricts communities from getting connected.

To avoid the preemption issue during the pandemic, some cities have established narrow versions of municipal broadband. In addition, these cities are providing free connectivity in heavily populated communities. For example, during the pandemic, Chattanooga, Tennessee, offered free broadband to low-income students. If these solutions stay in place, they will set an industry precedent for providing broadband to low-income communities.

Subsidies

The emergency Broadband Benefit provides up to $50 per month towards broadband services for eligible households and $75 a month for households on tribal lands. To qualify for the program, a household must meet one of five standards. Congress created the program to help low-income households stay connected during the pandemic. Congress allocated $3.2 billion to the FCC to enable the agency to provide the discount. This discount also comes with a one-time device discount of up to $100 so that users not only have broadband but have the tools to utilize broadband. The advantage of this subsidy is it directly addresses the issue of low-income recipients not being able to afford broadband, which can immediately affect the 15% of Americans who do not have broadband.

The downside of this solution is to qualify, a recipient must share their income on a webpage they have not visited before, which can be invasive. Further, this plan does not permanently address the cost of broadband, and once it ends, it is possible that the same groups of Americans who could not afford broadband before lose access to the internet. Additionally, when the average cost of a laptop in America is $700, a discount of $100 does not do very much to ensure that users are correctly benefitting from their new broadband connection. If the goal is to ensure that users can attend classes, complete homework assignments, and maybe play esports on the side, then a lower-cost tablet ($350 on average) would not address the problem of needing hardware to access broadband.

However, a program like this could be valued as a reasonable start if things continue to go in the right direction. A fair price for broadband is $60 a month. Reducing the cost of broadband to $10 per recipient for competitive speeds and reliability after subsidization could be a great tool to eliminate the digital divide so long as it persists after the pandemic.

Low-Income Broadband Laws

Low-cost broadband laws would require internet service providers to provide broadband plans for low-income recipients at a low-cost price. This approach would directly address Americans with physical access to broadband but who cannot pay for broadband solutions due to cost, thus, helping to bridge the digital divide. Low-cost broadband plans such as New York’s proposed Affordable Broadband Act would require all internet service providers serving more than 20,000 households to provide two low-cost plans to qualifying (low income) customers. However, New York’s law was stymied by ISPs arguing that it is an illegal way to close the digital divide as states are preempted from rate regulation of broadband by the Federal Communications Commission.

The ISPs argued that the Affordable Broadband Act operated within the field of interstate commerce and was thus likely preempted by the Federal Communications Act of 1934. However, as broadband is almost always interstate commerce, other state laws similar to New York’s Affordable Broadband Act would probably run into the same issue. Thus, a low-income broadband law would likely need to come from the federal level to avoid the same road bumps.

The Future of Broadband and the Digital Divide

An overlapping theme between many of these solutions is that they were implemented during the pandemic; this begs the question, are these short-term solutions to an unexpected life-changing event or rational long-term solutions for various long-term problems, including the pandemic? If cities, states, and the nation stay the course and implement more low-cost broadband solutions such as municipal internet, subsidies, and low-income broadband laws, it will be possible to address the digital divide. However, if jurisdictions treat these solutions like short-term stopgaps, communities that cannot afford traditional broadband solutions will again lose broadband access. Students will again go to McDonald’s to do homework assignments, and Aphromoo may continue to be the only active African American LCS player.

Quantum Computing: Ready to Be Patented!

November 12, 2021
Intellectual Property, Patents, Uncategorized

Shuang Liu, MJLST Staffer

In June 2021, IBM presented its newest and most powerful quantum computer—Q System One. This news highlighted people’s continuing confidence and resolution in the research and development of quantum computing. As a matter of fact, several countries and leading high-tech corporations are investing from millions to billions in various aspects of quantum computing technology, and filing patent applications to protect their research achievement.

(Q System One at Fraunhofer-Gesellschaft, Germany)

This article attempts to provide a brief introduction of quantum computing technology (Part I), a potentiometric analysis of the high-tech corporations in quantum computing industry (Part II), and a discussion of potential legal challenges in obtaining patents related to quantum software (Part III).

I. The Quantum Computing Technology and Its Potential Applications

The world’s most famous cat, Schrödinger’s cat, is both alive and dead until it is observed. A quantum bit (“qubit”) behaves similarly—it is both 0 and 1 until it is measured. A classical computer transmits and processes n-bit information with n bits. In contrast, since a qubit represents 0 and 1 at the same time (that is, a superposition of 0 and 1), a quantum computer transmits and processes 2n-bit information with n qubits. Therefore, if a good algorithm is found and the superposition property is utilized properly, a quantum computer can compute exponentially faster than a classical computer.

However, algorithms for quantum computers (hereinafter “quantum algorithms”) are not easy to find and algorithms for classical computers (hereinafter “classical algorithms”) cannot be readily applied on quantum computers. After all, classical algorithms solve problems in a deterministic way (where bits are either 0 or 1), while a quantum computer by its nature processes probabilistic information (where bits are superpositions of 0 and 1). It took people decades to develop the first quantum algorithm that showed capability of solving real-life problems. To date, although quantum algorithms are still far from enough, the available ones do show a great potential of applications.

The first, surest application is cryptanalysis. Integer factorization plays a key role in cryptanalysis. The Shor’s algorithm, one of the most famous quantum algorithms, is able to factor all integers in polynomial time, which has not been made possible by classical algorithms so far.

Another promising application is predicting new chemicals and materials having certain properties. Properties of chemicals and materials usually depend on a variety of factors and can be too complicated for a classical computer to make simulations. A quantum computer, with a stronger computation power, is expected to be able to make such simulations. To be noted, researchers are hopeful to use a quantum computer to find a way to build materials that can be superconducting at room temperature.

Complex processes, such as biological processes, economic development modelling, energy allocation optimization, and big data processing, are also good candidates for which a quantum computer can use its exceptional computation power.

II. Patent Landscape of Leading Corporations

People’s confidence in the potential of quantum computing leads to a race in patents. In the last five years, nearly a thousand patent applications related to quantum computing have been filed in the US, and a little bit fewer before the WIPO.

The figures below show the number of applications filed by leading corporations related to quantum computing and the number of applications related to specific areas. Among them, IBM is the first active patent applicant, leading other corporations by big margins and showing interest in almost every aspect of quantum computing. Other leading applicants are interested in different aspects of quantum computing. For example, Microsoft is mainly working on the software side (machine learning and optimization), while Intel devotes its most energy on the hardware side (quantum circuits). It is also worth noting that Bank of America has filed many applications in the cryptology aspect of quantum computing—it is endeavoring to be the first to use quantum security keys to protect its data.

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Figure 1

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Figure 2

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Figure 3

Turning our eyes to the world, we can see that Huawei, a Chinese telecommunication company, has filed a large number of quantum computing related applications before the World Intellectual Property Office (WIPO). Its major interests reside in quantum communication and securing such communication with cryptographs. NEC, a Japanese electronics corporation is also an active global patent applicant. It mainly focuses on building a quantum computer itself.

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Figure 4

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Figure 5

III. Potential Legal Issues

In the process of obtaining a patent, the most common substantive rejections are novelty and obviousness rejections. For a quantum software application, a patent-eligibility rejection is also likely. The subsections below discuss patent-eligibility and obviousness challenges especially for quantum software applications.

A. Patent Eligibility

The case law on patent eligibility of software has been unclear and inconsistent. This subsection does not attempt to, nor can it, predict the patent eligibility of quantum software. But at least there are more arguments available for patent eligibility of quantum software than those of classical software.

Courts tend to find a software claim ineligible if it is “not tied to any particular novel machine or apparatus, only a general-purpose computer.” From a policy perspective, such claims are disfavored by courts because “[they] would risk disproportionately tying up the use of the underlying ideas and . . . pose . . . risk of pre-emption.”

To facilitate discussion and avoid confusion, the remainder of this and next subsection will discuss with claim 1 ofU.S. Pat. No. US10990677B2 (hereinafter “‘677 claim 1”):

“A method, comprising:

programming a quantum computing device to implement quantum circuits that perform a machine learning technique using one or more qubits of the quantum computing device, wherein the machine learning technique employs principal component analysis based on at least one median estimate stored as a quantum bit string . . . .”

In a nutshell, ‘677 claim 1 recites a machine learning technique implemented by a quantum computing device. It was drafted in a way that it is closely tied to the quantum computing device, in contrast to “a general-purpose computer.” Therefore, if challenged, the patentee can always argue that this method is closely tied to “a particular novel machine,” and can’t possibly preempt all use of the underlying concept in the claim.

It is worth noting that, instead of simply claiming a machine learning method implemented by a quantum computer, the claim ties the implementation with “quantum circuits” and “one or more qubits.” When drafted this way, the patentee has a strong argument that this claim is not an abstract idea under the commonly used pen and paper test,because a human cannot implement quantum circuits and/or use qubits either mentally or by a pen and a piece of paper.

Other quantum software or algorithm patents might have other arguments available. For example, the patent eligibility of an error correction algorithm patent can be supported by the fact that it greatly improved the performance of a quantum computer, which is a common theme of the current case law of patent eligibility.

B. Obviousness

As can be expected, ‘677 claim 1 has been challenged under 35 U.S.C. §103. In the Non-Final Office Action, the Examiner asserted Mork et al. in view of Kappor et al. in further view of Kerner et al. renders the claim obvious, wherein Mork discloses a classical computer implementing a similar machine learning technique, Kerner discloses a quantum computing device, and Kappor recites that “[t]he machine learning acceleration hardware . . . may comprise . . . a quantum computing device” without providing any details. Such a combination of references can be a recipe for obviousness rejections against quantum software claims.

The key for this rejection to stand is the “connecting” reference (in this example, Kappor), that is, how the classical algorithm can be connected to a quantum computing device. As discussed in Section I of this article, it’s not just that the computation powers of a classical computer and a quantum computer are different; the ways they compute are not at all the same.

Accordingly, for this specific example, the rejection is erroneous because Kappor does not provide any details of how to apply its machine learning process to a quantum computing device, let alone providing teachings of how to apply the machine learning technique disclosed by Mork to a quantum computer. In general, a reference that motivates and teaches to apply a classical algorithm on a quantum computer can be extremely difficult to find. That is because, there is few, if any, classical algorithm can be readily applied on a quantum computer!

Therefore, it is fair to say that a reference in the classical software domain is almost never effective to defeat the patentability of a quantum software.

Conclusion

Although quantum computing technology is still in its infancy, people are very confident in its potential. Corporations in the industries of communication, computing, electronics, and even finance have joined the patent race of quantum computing related technologies. The patent space of quantum computing technology is still quite sparce, and a patent on quantum computing can be obtained much more easily now than later.

Kids’ Choice? COVID-19 Shots

November 10, 2021
Uncategorized

Carly Michaud, MJLST Staffer

At the end of October, the CDC broadened the eligibility for COVID-19 vaccines by adding booster shots for people with specific risk factors who have already been vaccinated, and the long-awaited authorization of shots for children ages 5-11. But with eligibility expanding, the fights over public-school vaccine mandates are sure to increase in intensity. The ultimate question is who has the final say on the health and safety of children in public school: the educators, the parents, or perhaps the students themselves. In addition to the rights of public schools and parents to make decisions around childhood vaccinations, states and public health experts have started to endorse legal processes for teens to consent to vaccination without parental consent.

School Authority

School districts can issue and enforce vaccine mandates through a delegation of state police powers. Through the doctrine of parens patriae, the state holds the power to intervene to protect citizens, including children when the parent is not adequately assuring their health and safety. However, in comparison to the broadness of parens patriae, schools have traditionally had a duty to protect children via the doctrine of in loco parentis, which gives the school the authority of the parents while the child is attending. Schools districts retain authority because of the need to protect the health of children and staff at their facility.

All states have some required vaccinations for children attending public schools, including MMR, Tdap, and varicella (aka. Chickenpox). MMR and Tdap are both combination vaccines protecting against measles, mumps, rubella, (MMR) and diphtheria, tetanus, and pertussis (Tdap). Vaccination mandates are a common public health measure taken particularly for those who are considered medically vulnerable populations and those who work with those populations. Children are considered medically vulnerable due to a variety of factors, including  psychological development, behavioral development, and significantly more daily person-to-person social contacts, making them unique from adults.

Mandatory vaccination has been a common public health practice since the turn of the 20th century and the widespread development and availability of vaccines. In 1905 the Supreme Court upheld a smallpox vaccine mandate enforced by a municipal Board of Health in Massachusetts as a reasonable exercise of state police power. As vaccine availability grew the Supreme Court also affirmed the applicability of vaccine mandates for school children in Zucht v. King. This doctrine has remained well-settled even to the present day, as mere days ago the Supreme Court denied injunctive relief to stop a state level vaccine mandate for health care workers.

Parent/Guardian Authority

The parent or guardian is automatically assumed to care for their child and have a right to do so in the way the parent or guardian sees fit, which is protected under the Fourteenth Amendment’s fundamental rights of parents. The state has been deferential to parental rights under the Fourteenth Amendment, however that deference has not extended to unvaccinated children attending schools without a legally approved exception. Despite the legal control parents have over their children, school districts are able to use their authority to compel students attending their facility to be vaccinated against certain diseases.

Self-Authorizing?

Due to the COVID-19 pandemic, more jurisdictions in the United States have given children ages 11 or 12 and older the ability to consent to vaccinations without parental consent. Ethicists have affirmed this policy noting that as children develop autonomy, it is reasonable to rely on their ability to consent to high benefit and low risk health decisions. This policy has been in place in a variety of states and municipalities for numerous years for other vaccines and medical decisions. Now it is being utilized by teens for COVID-19 vaccines.

The American Medical Association is in favor of autonomous teen vaccination as it “maximize[s] immunization opportunities for children” and is already the standard for teens who are effectively independent due to homelessness, unaccompanied status, or military service. This policy also offers protection for teens who do not want to inform a parent of their desire to receive specific preventable or immediate medical care. Many of these laws exist to allow teenagers to choose to receive contraception and the HPV vaccine.

While teens are able to make some health decisions for themselves, the majority of children in the United States are between the ages of 0 and 11. The most recent authorization applies to children in the age 5-11 group, who are still reliant on school vaccine mandates to protect their health and stop the spread of COVID-19 in schools.

Vaccine mandates in schools protect the health of students, faculty and the larger community from the spread of disease. In the case of COVID-19, the Pfizer-BioNTech vaccine has been approved for children ages 5-11 and is over 90% effective, and for children ages 12-15 and has the same efficacy as the original vaccine for adults. (Children ages 16-18 were included in the original Emergency Use Authorization for Pfizer’s vaccine, which is over 95% effective). It is vital schools maintain the power to require student vaccinations to prevent the unnecessary death of students and teachers from a lack of vaccine access and acceptance.

With Lull in Deepfake Legislation, Questions Loom Large as Ever

November 6, 2021
Uncategorized

Alex O’Connor, MJLST Staffer

In 2019 and 2020, remarkably realistic forged politically motivated content went viral on social media. The content, known as “deepfakes,” included photorealistic images of world leaders such as Kim Jong Un, Vladimir Putin, Matt Gaetz, and Barack Obama. Also in 2019, a woman was conned out of nearly $300,000 by a scammer posing as a U.S. Navy Admiral using deepfake technology. These stories, and others, catapulted online forgeries to the front page of newspapers, as observers were both intrigued and frightened by this novel technology. 

While the potential for deepfake technology to deceive political leaders and provoke conflict helped bring deepfakes into the public consciousness, individuals — and particularly women — have been victimized by deepfakes since as early as 2017. Even today, research suggests that 96% of deepfake content available online is nonconsensual pornography. While early targets of deepfakes were mostly celebrity women, nonpublic figures have been victimized as well. Indeed, deepfake technology is becoming increasingly more sophisticated and user friendly, giving anyone inclined the ability to forge pornography using a woman’s photograph transposed over explicit content in order to harass, blackmail, or embarrass. For example, one deepfake app allowed users to strip a subject’s clothing from photos, creating a photorealistic nude image. After widespread outcry, the developers of the app shut it down only hours after its launch. 

The political implications of deepfakes alarmed lawmakers as well, and congress leapt into action. Beginning in 2020, the National Defense Authorization Act (NDAA) included a requirement that the Department of Homeland Security (DHS) issue an annual report on the threats that deepfake technology poses for national security. The following year, the NDAA broadened the DHS report to include threats to individuals as well. Another piece of legislation, the Identifying Outputs of Generative Adversarial Networks Act, directed the National Institute of Standards and Technology to support research for developing standards related to deepfake content. 

A much more controversial bill went beyond mere research and committees. The DEEP FAKES Accountability Act would require any producer of deepfake content to include a watermark over the image notifying viewers that it was a forgery. If the content contains “sexual content of a visual nature,” producers of unwatermarked content would be subject to criminal penalties. Meanwhile, anyone who merely violates the watermark requirement would be subject to civil penalties of $150,000 per image. 

While many have celebrated the bill for its potential to protect individuals and the political process, others have criticized it as an overbroad and ineffective infringement on free speech. Producers of political satire in particular may find the watermark requirement a joke killer. Further, some worry that the pace of deepfake technology development could expose websites to interminable litigation as the proliferation of deepfake content renders enforcement of the act on platforms impossible. Originally introduced in June 2019 by Representative Yvette Clarke, [D-NY-9], the bill languished in committee. Representative Clarke reintroduced the bill in April of this year before the 117th Congress, and it is currently being considered by three committees: Energy and Commerce, Judiciary, and Homeland Security.

The flurry of legislative activity at the federal level was mirrored by engagement by states as well. Five states have enacted deepfake legislation to combat political interference, nonconsensual pornography, or both, while another four states have introduced similar legislation. As with the federal legislation, opposition to the state deepfake laws is grounded in First Amendment concerns, with defenders of civil liberties such as the ACLU sending a letter to the California governor asking him to veto the legislation. He declined.

Deepfake related legislative activity has stalled during the Coronavirus pandemic, but the questions around how to craft legislation that strikes the right balance between privacy and dignity on the one hand, and free expression and satire on the other loom large as ever. These questions will only become more relevant with the rapid growth of deepfake technology and growing concerns about governmental overreach in good-faith efforts to protect citizens’ privacy and the democratic process.

Whitelist for Thee, but Not for Me: Facebook File Scandals and Section 230 Solutions

November 6, 2021
Data, Economics, Privacy, Social Media, Social Welfare, Uncategorized

Warren Sexson, MJLST Staffer

When I was in 7th grade, I convinced my parents to let me get my first social media account. Back in the stone age, that phrase was synonymous with Facebook. I never thought too much of how growing up in the digital age affected me, but looking back, it is easy to see the cultural red flags. It came as no surprise to me when, this fall, the Wall Street Journal broke what has been dubbed “The Facebook Files,” and in them found an internal study from the company showing Instagram is toxic to teen girls. While tragic, this conclusion is something many Gen-Zers and late-Millennials have known for years. However, in the “Facebook Files” there is another, perhaps even more jarring, finding: Facebook exempts many celebrities and elite influencers from its rules of conduct. This revelation demands a discussion of the legal troubles the company may find itself in and the proposed solutions to the “whitelisting” problem.

The Wall Street Journal’s reporting describes an internal process by Facebook called “whitelisting” in which the company “exempted high-profile users from some or all of its rules, according to company documents . . . .” This includes individuals from a wide range of industries and political viewpoints, from Soccer mega star Neymar, to Elizabeth Warren, and Donald Trump (prior to January 6th). The practice put the tech giant in legal jeopardy after a whistleblower, later identified as Frances Haugen, submitted a whistleblower complaint with the Securities and Exchange Commission (SEC) that Facebook has “violated U.S. securities laws by making material misrepresentations and omissions in statements to investors and prospective investors . . . .” See 17 CFR § 240.14a-9 (enforcement provision on false or misleading statements to investors). Mark Zuckerberg himself has made statements regarding Facebook’s neutral application of standards that are at direct odds with the Facebook Files. Regardless of the potential SEC investigation, the whitelist has opened up the conversation regarding the need for serious reform in the big tech arena to make sure no company can make lists of privileged users again. All of the potential solutions deal with 47 U.S.C. § 230, known colloquially as “section 230.”

Section 230 allows big tech companies to censor content while still being treated as a platform instead of a publisher (where they would incur liability for what is on their website). Specifically, § 230(c)(2)(A) provides that no “interactive computer service” shall be held liable for taking action in good faith to restrict “obscene, lewd, lascivious, filthy, excessively violent, harassing, or otherwise objectionable [content] . . . .” It is the last phrase, “otherwise objectionable,” that tech companies have used as justification for removing “hate speech” or “misinformation” from their platform without incurring publisher like liability. The desire to police such speech has led Facebook to develop stringent platform rules which has in turn created the need for whitelisting. This brings us to our first proposal, eliminating the phrase “otherwise objectionable” from section 230 itself. The proposed “Stop the Censorship Act of 2020” brought by Republican Paul Gosar of Arizona does just that. Proponents argue that it would force tech companies to be neutral or lose liability protections. Thus, no big tech company would ever create standards stringent enough to require a “whitelist” or an exempted class, because the standard is near to First Amendment protections—problem solved! However, the current governing majority has serious concerns about forced neutrality, which would ignore problems of misinformation or the mental health effects of social media in the aftermath of January 6th.

Elizabeth Warren, similar to a recent proposal in the House Judiciary Committee, takes a different approach: breaking up big tech. Warren proposes passing legislation to limit big tech companies in competing with small businesses who use the platform and reversing/blocking mergers, such as Facebook purchasing Instagram. Her plan doesn’t necessarily stop companies from having whitelists, but it does limit the power held by Facebook and others which could in turn, make them think twice before unevenly applying the rules. Furthermore, Warren has called for regulators to use “every tool in the toolbox,” in regard to Facebook.

Third, some have claimed that Google, Facebook, and Twitter have crossed the line under existing legal doctrines to become state actors. So, the argument goes, government cannot “induce” or “encourage” private persons to do what the government cannot. See Norwood v. Harrison, 413 U.S. 455, 465 (1973). Since some in Congress have warned big tech executives to restrict what they see as bad content, the government has essentially co-opted the hand of industry to block out constitutionally protected speech. See Railway Employee’s Department v. Hanson, 351 U.S. 225 (1956) (finding state action despite no actual mandate by the government for action). If the Supreme Court were to adopt this reasoning, Facebook may be forced to adopt a First Amendment centric approach since the current hate speech and misinformation rules would be state action; whitelists would no longer be needed since companies would be blocked from policing fringe content. Finally, the perfect solution! The Court can act where Congress cannot agree. I am skeptical of this approach—needless to say, such a monumental decision would completely shift the nature of social media. While Justice Thomas has hinted at his openness to this argument, it is unclear if the other justices will follow suit.

All in all, Congress and the Court have tools at their disposal to combat the disturbing actions taken by Facebook. Outside of potential SEC violations, Section 230 is a complicated but necessary issue Congress must confront in the coming months. “The Facebook Files” have exposed the need for systemic change in social media. What I once used to use to play Farmville, has become a machine that has rules for me, but not for thee.

Monumental Tug-of-War: America’s National Monuments May Be the Latest Targets in the Partisan Policy Back-and-Forth

October 19, 2021
Environment, Environmental Law, Public Lands

Douglas Harman, MJLST Staffer

On October 7, 2021, the Biden Administration moved to restore the size and protections of two national monuments in the state of Utah: Bears Ears National Monument and Grand Staircase-Escalante National Monument. This latest action culminates a back-and-forth of the last three presidencies that has drawn national attention. It suggests an emerging pattern of using national monuments as part of a broader legal and political debate over the use of federal lands.

There is a cultural and political split with liberals broadly favoring conservation/preservation of wilderness and Native American heritage sites and conservatives broadly favoring resource extraction and land development. It now seems likely that national monuments, and the underlying law dealing with their creation, will be subject to the same intense partisan tug-of-war as are other federal land use policies.

 

The Antiquities Act of 1906 and National Monuments

In the early 20th century, Congress passed the Antiquities Act, delegating to the President the power to “declare by public proclamation historic landmarks, historic and prehistoric structures, and other objects of historic or scientific interest [situated on federal lands]…to be national monuments.” Once a monument is established, the antiquities act also provides for its protection, and penalizes anyone who detrimentally interferes with it. Such a grant of power is quite significant, as it allows a President to designate areas for protection without the requirement for an act of Congress, as is needed for national parks. It is also important to note that, although the statute expressly authorizes the creation of national monuments, the statute is silent about the reduction or dissolution of the same. For this reason, there is general consensus that the President lacks granted or implied authority to completely abolish a national monument without congressional approval (though, as discussed below, some Presidents have reduced the sizes of monuments). 

Because it allows Presidents a relatively free hand in preserving lands and does not require congressional approval (with some exceptions added later for Wyoming and Alaska), Presidents have used the Antiquities Act quite frequently to designate lands as monuments. As an additional incentive, the Supreme Court has generally held that Presidents have extremely broad discretion when creating national monuments, and that a designation as a monument protects incidental resources needed to maintain the monument. See Cameron v. United States, 252 U.S. 450 (1920); Cappaert v. United States, 426 U.S. 128 (1976). There are currently 129 National Monuments ranging widely in area and character. Though there has been some controversy over creation of monuments in the past, there had been no record of a President unmaking or effectively undercutting a monument made by a predecessor prior to 2017.

Debate remains around whether and to what extent a President can diminish a national monument. Despite Presidents reducing the size of existing monuments in the past (the last President to do so before Trump was Eisenhower), courts have never squarely addressed the issue of whether and how much a President may reduce an already-created National Monument. Additionally courts have not addressed the companion issue of what level of reduction would constitute an effective abolition of the monument, and might therefore exceed a President’s authority under the Antiquities Act.

 

Clinton/Obama, then Trump, then Biden

President Clinton established Grand Staircase as a National Monument by proclamation in 1996, a move that sparked controversy in Utah, but received relatively little attention overall and was hardly a national issue of concern. Clinton’s Republican successor, George W. Bush, took no action against Grand Staircase in the eight years he was President. Years later, in December of 2016, as negotiations between Native American Nations and Utah fell apart, and with an eye on both his legacy and his successor, President Obama signed a declaration creating Bears Ears National Monument. Environmentalists, Native American Nations, and academic groups hailed Bears Ears as protecting unique habitats, historical areas, and indigenous sacred sites. However, Utah locals and politicians, as well as various resource-extraction industries, derided the creation of Bears Ears as federal government overreach and a denial of resources to the state.

When the Trump Administration took office in 2017, it had a different set of goals for federal lands. In addition to environmental deregulation and increased oil and gas extraction, Trump signed a proclamation in late 2017 to shrink Bears Ears and Grand Staircase. The actions sparked public interest for two reasons. First, because no President since Eisenhower had reduced a national monument, and previous reductions and revisions of boundaries appear to have been relatively non-controversial. Second, because the reduction proclaimed by Trump amounted to the largest reduction of national monument land in US history, reducing Bears Ears by 85% and Grand Staircase by 50%. The action was promptly challenged in court, with plaintiffs arguing that the reduction effectively abolished the monuments, thereby intruding on congressional powers. Wilderness Society v. Trump, 2019 WL 7902967 (Nov. 2019) (trial pleading). There was an additional legal issue regarding Grand Staircase, as Congress statutorily recognized and modified the monument in 1998, raising the question of whether a President could unilaterally further alter a monument with borders designated by Congress.  The case dragged on in DC courts and has not yielded a clear resolution as of this writing (and is unlikely to do so, as Trump is no longer President and the proclamation reducing the size of the monuments has now been superseded).

President Trump was defeated in the 2020 election, and Joe Biden became President. One of his myriad goals was to restore environmental protections undone during his predecessor’s term. This included restoring Bears Ears and Grand Staircase to their pre-Trump sizes (in the same proclamation, Biden restored protections to the marine Northeast Canyons and Seamounts National Monument, which Trump had opened to commercial fishing). This has meant that, just like many other land use and environmental priorities, the pendulum has swung on national monuments based solely on the party affiliation of the occupant of the White House.

 

The Future of National Monuments

In the proclamations restoring the monuments, the Biden Administration took no legal issue with the actions of the Trump Administration. There was no claim that the diminishment had been illegal or unconstitutional; there have been no circulated legal memos denouncing the Trump White House’s legal logic as flawed; and there has been no argument that the reduction exceeded the scope of Presidential power by effectively abolishing the monuments. The reversal of policy has also essentially rendered any court decision of the cases against the Trump administration moot. This means that, although the Biden administration undid Trump’s actions, it appears to have tacitly accepted and affirmed their validity. This means the pattern of the last several years can (and probably will) be repeated.

It does not take a huge logical jump, then, to imagine the national monuments pulled into a perpetual seesaw. Perhaps a Republican takes the White House in 2024 or 2028 and moves to slash the size of national monuments as Trump did, only for them to be re-expanded by a future Democrat. Perpetual change of federal land designation, and, therefore, use, is not good for anyone. Industry will be disincentivized from making investments in development on lands that could be incorporated or re-incorporated into a protected National Monument, while environmental and Native American groups will have to be constantly on the alert for actions from a hostile President unilaterally undoing everything they’ve worked extremely hard to protect on national monument land. 

Such a policy seesaw hurts everyone. It seems evident that the unilateral and unlimited Presidential power to create and diminish National Monuments will lead to significant instability as long as the major parties have such diametrically opposed land use goals. One possible solution is for Congress to amend the law, but that seems unlikely given Congress’s declining productivity in the last several years and the political divisions in an evenly split Congress. Without Congressional action, further guidance from the courts about the extent of a President’s legal ability under the Antiquities Act to diminish national monuments may be the only way to stabilize the process. The question is when, and if, the courts will have their chance to weigh in.

You Wouldn’t 3D Print Tylenol, Would You?

October 12, 2021
3-D Printing, Administrative Law, Bioethics, Biotechnology, FDA, Food and Drug Law, Health, Healthcare, Healthcare Reform, Medical Devices, Personalized Medicine, Pharmaceuticals, Uncategorized

By Mason Medeiros, MJLST Staffer

3D printing has the potential to change the medical field. As improvements are made to 3D printing systems and new uses are allocated, medical device manufacturers are using them to improve products and better provide for consumers. This is commonly seen through consumer use of 3D-printed prosthetic limbs and orthopedic implants. Many researchers are also using 3D printing technology to generate organs for transplant surgeries. By utilizing the technology, manufacturers can lower costs while making products tailored to the needs of the consumer. This concept can also be applied to the creation of drugs. By utilizing 3D printing, drug manufacturers and hospitals can generate medication that is tailored to the individual metabolic needs of the consumer, making the medicine safer and more effective. This potential, however, is limited by FDA regulations.

3D-printed drugs have the potential to make pill and tablet-based drugs safer and more effective for consumers. Currently, when a person picks up their prescription the drug comes in a set dose (for example, Tylenol tablets commonly come in doses of 325 or 500 mg per tablet). Because the pills come in these doses, it limits the amount that can be taken to multiples of these numbers. While this will create a safe and effective response in most people, what if your drug metabolism requires a different dose to create maximum effectiveness?

Drug metabolism is the process where drugs are chemically transformed into a substance that is easier to excrete from the body. This process primarily happens in the kidney and is influenced by various factors such as genetics, age, concurrent medications, and certain health conditions. The rate of drug metabolism can have a major impact on the safety and efficacy of drugs. If drugs are metabolized too slowly it can increase the risk of side effects, but if they are metabolized too quickly the drug will not be as effective. 3D printing the drugs can help minimize these problems by printing drugs with doses that match an individual’s metabolic needs, or by printing drugs in structures that affect the speed that the tablet dissolves. These individualized tablets could be printed at the pharmacy and provided straight to the consumer. However, doing so will force pharmacies and drug companies to deal with additional regulatory hurdles.

Pharmacies that 3D print drugs will be forced to comply with Current Good Manufacturing Procedures (CGMPs) as determined by the FDA. See 21 C.F.R. § 211 (2020). CGMPs are designed to ensure that drugs are manufactured safely to protect the health of consumers. Each pharmacy will need to ensure that the printers’ design conforms to the CGMPs, periodically test samples of the drugs for safety and efficacy, and conform to various other regulations. 21 C.F.R. § 211.65, 211.110 (2020). These additional safety precautions will place a larger strain on pharmacies and potentially harm the other services that they provide.

Additionally, the original drug developers will be financially burdened. When pharmacies 3D print the medication, they will become a new manufacturing location. Additionally, utilizing 3D printing technology will lead to a change in the manufacturing process. These changes will require the original drug developer to update their New Drug Application (NDA) that declared the product as safe and effective for use. Updating the NDA will be a costly process that will further be complicated by the vast number of new manufacturing locations that will be present. Because each pharmacy that decides to 3D print the medicine on-site will be a manufacturer, and because it is unlikely that all pharmacies will adopt 3D printing at the same time, drug developers will constantly need to update their NDA to ensure compliance with FDA regulations. Although these regulatory hurdles seem daunting, the FDA can take steps to mitigate the work needed by the pharmacies and manufacturers.

The FDA should implement a regulatory exception for pharmacies that 3D print drugs. The exemption should allow pharmacies to avoid some CGMPs for manufacturing and allow pharmacies to proceed without being registered as a manufacturer for each drug they are printing. One possibility is to categorize 3D-printed drugs as a type of compounded drug. This will allow pharmacies that 3D print drugs to act under section 503A of the Food Drug & Cosmetic Act. Under this section, the pharmacies would not need to comply with CGMPs or premarket approval requirements. The pharmacies, however, will need to comply with the section 503A requirements such as having the printing be performed by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician, limiting the interstate distribution of the drugs to 5%, only printing from bulk drugs manufactured by FDA licensed establishments and only printing drugs “based on the receipt of a valid prescription for an individualized patient”. Although this solution limits the situations where 3D prints drugs can be made, it will allow the pharmacies to avoid the additional time and cost that would otherwise be required while helping ensure the safety of the drugs.

This solution would be beneficial for the pharmacies wishing to 3D print drugs, but it comes with some drawbacks. One of the main drawbacks is that there is no adverse event reporting requirement under section 503A. This will likely make it harder to hold pharmacies accountable for dangerous mistakes. Another issue is that pharmacies registered as an outsourcing facility under section 503B of the FD&C Act will not be able to avoid conforming to CGMPs unless they withdraw their registration. This issue, however, could be solved by an additional exemption from CGMPs for 3D-printed drugs. Even with these drawbacks, including 3D-printed drugs under the definition of compounded drugs proposes a relatively simple way to ease the burden on pharmacies that wish to utilize this new technology.

3D printing drugs has the opportunity to change the medical drug industry. The 3D-printed drugs can be specialized for the individual needs of the patient, making them safer and more effective for each person. For this to occur, however, the FDA needs to create an exemption for these pharmacies by including 3D-printed drugs under the definition of compounded drugs.

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