Articles by mjlst

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.

What the SolarWinds Hack Means for the Future of Law Firm Cybersecurity?

April 24, 2021
Cyber Security, Data, Data Privacy

Sam Sylvan, MJLST Staffer

Last December, the massive software company SolarWinds acknowledged that its popular IT-monitoring software, Orion, was hacked earlier in the year. The software was sold to thousands of SolarWinds’ clients, including government and Fortune 500 companies. A software update of Orion provided Russian-backed hackers with a backdoor into the internal systems of approximately 18,000 SolarWinds customers—a number that is likely to increase over time as more organizations discover that they also are victims of the hack. Even the cybersecurity company FireEye that first identified the hack had learned that its own systems were compromised.

The hack has widespread implications on the future of cybersecurity in the legal field. Courts and government attorneys were not able to avoid the Orion hack. The cybercriminals were able to hack into the DOJ’s internal systems, leading the agency to report that the hackers might have breached 3,450 DOJ email inboxes. The Administrative Office of the U.S. Courts is working with DHS to audit vulnerabilities in the CM/ECF system where highly sensitive non-public documents are filed under seal. Although, as of late February, no law firms had announced that they too were victims of the hack, likely because law firms do not typically use Orion software for their IT management, the Orion hack is a wakeup call to law firms across the country regarding their cybersecurity. There have been hacks, including hacks of law firms, but nothing of this magnitude or potential level of sabotage. Now more than ever law firms must contemplate and implement preventative measures and response plans.

Law firms of all sizes handle confidential and highly sensitive client documents and data. Oftentimes, firms have IT specialists but lack cybersecurity experts on the payroll—somebody internal who can aid by continuing to develop cybersecurity defenses. The SolarWinds hack shows why this needs to change, particularly for law firms that handle an exorbitant amount of highly confidential and sensitive client documents and can afford to add these experts to their ranks. Law firms relying exclusively on consultants or other third parties for cybersecurity only further jeopardizes the security of law firms’ document management systems and caches of electronically stored client documents. Indeed, it is reliance on third-party vendors that enabled the SolarWinds hack in the first place.

In addition to adding a specialist to the payroll, there are a number of other specific measures that law firms can take in order to address and bolster their cybersecurity defenses. For those of us who think it is not a matter of “if” but rather “when,” law firms should have an incident response plan ready to go. According to Jim Turner, chief operating officer of Hilltop Consultants, many law firms do not even have an incident response plan in place.

Further, because complacency and outdated IT software is of particular concern for law firms, “vendor vulnerability assessments” should become commonplace across all law firms. False senses of protection need to be discarded and constant reassessment should become the norm. Moreover, firms should upgrade the type of software protection they have in place to include endpoint detection and response (EDR), which uses AI to detect hacking activity on systems. Last, purchasing cyber insurance is a strong safety measure in the event a law firm has to respond to a breach. It would allow for the provision of additional resources needed to effectively respond to hacks.

NFTs and the Tweet Worth $2.9 Million: Beliefs Versus the Legal Reality

April 24, 2021
Copyrights, Intellectual Property, Internet, Property Law

Emily Newman, MJLST Staffer

A clip of Lebron James dunking a basketball, a picture of Lindsay Lohan’s face, and an X-ray of William Shatner’s teeth—what do all these seemingly random things have in common? They’ve all been sold as NFTs for thousands to hundreds of thousands of dollars. It seems like almost everyone, from celebrities to your “average Joe” is taking part in this newest trend, but do all parties really know what they’re getting themselves into? Before addressing that point, let’s look at what exactly are these “NFTs.”

What are they?

NFT stands for “non-fungible token.” In contrast to fungible items, this means that it is unique and can’t be traded or replaced for something else. As explained by Mitchell Clark from The Verge, “a bitcoin is fungible — trade one for another bitcoin, and you’ll have exactly the same thing. A one-of-a-kind trading card, however, is non-fungible. If you traded it for a different card, you’d have something completely different.” NFTs can basically be anything digital, and while headlines have been made over Twitter founder Jack Dorsey selling his first tweet as an NFT for $2.9 million, their popularity has really exploded within the world of digital art. Examples include the Nyan Cat meme selling for around $700,000 and the artist Beeple selling a collage of his work at Christie’s for $69 million (for reference, Monet’s “Nymphéas,” was sold for $54 million in 2014).

Anyone can download and view NFTs for free, so what is all the hype about? Buyers get ownership of the NFT. “To put it in terms of physical art collecting: anyone can buy a Monet print. But only one person can own the original.” This originality provides a sense of authenticity to the art, which is important these days “when forged art is proliferating online.” To facilitate this buying, selling, and reselling of digital art, several online marketplaces have emerged such as OpenSea (where one can purchase their very own CryptoKitties), Nifty Gateway, and Rarible.

NFTs, Copyright Law, and Consumer Protection

As mentioned above, NFT purchasers can own an original piece of digital art—but there’s a catch. Owning the NFT itself does not necessarily equate to ownership of the original work and its underlying copyright. In other words, buying an NFT “does not mean that the copyright to that artwork transfers to the buyer,” it is simply a “digital receipt showing that the holder owns a version of the work.” Without the underlying copyright, the purchaser of an NFT does not have the right to reproduce or prepare derivative works, or to distribute the work—that right belongs exclusively to the copyright owner.

Mike Shinoda, one of the musicians behind Linkin Park and an NFT artist himself, states that “there’s nobody who’s serious about NFTs who really humors the idea that what you’re selling is the copyright  . . . .” However, as Pramod Chintalapoodi from the Chip Law Group points out, oftentimes “buyers’ beliefs about what they own do not translate to legal reality.” Chintalapoodi also describes how companies who sell NFTs are not transparent about this either; for instance, Decentraland describes itself as the “first-ever virtual world owned by its users,” but “according to Article 12.1 of Decentraland’s Terms of Use, it is Metaverse Holdings Ltd. that owns all IP rights on the site.” However, its users still spend millions of dollars on the site buying NFTs.

Going forward, NFT purchasers should clarify with the seller about what exactly it is they are purchasing. Preston J. Byrne from CoinDesk encourages consumers to ask “are you buying information, copyrights, bragging rights or none or all of those things? Do you have the documentation to back all of that up?” Additionally, are you even buying an original work or did the seller create an NFT of someone else’s work? Asking these questions early on can help with avoiding “significant financial or legal pain down the road.” While it may not be the norm to receive the underlying copyright when purchasing an NFT today, and while lawmakers may not step in anytime soon (or at all) and force sellers to display their terms explicitly, it is predicted that transferring copyrights to the purchaser will be a “valued feature for NFT platforms” in the future.

 

One Person’s Trash Is Another’s Energy

April 18, 2021
Climate Change, Energy Law, Environment

Carlton Hemphill, MJLST Staffer

It comes to many as a literal and metaphorical breath of fresh air to see the new administration’s interest in reducing the effect we have on the environment, but achieving a goal of net-zero emissions by 2050 is no small feat for such a large country and requires leaving no stone unturned. Much of the recent focus in the media has been on increasing the prevalence of electric cars and switching to renewable energy sources that do not emit carbon dioxide or other greenhouse gases, such as wind and solar. That being said, there is another often overlooked process that, while not the end all solution, can still help us achieve this goal of reducing greenhouse gases, and in my opinion should be getting more attention than it is currently receiving. I am referring to the use of anaerobic digesters.

The Dirty Details:

Let’s face it, people generate a lot of waste, both food waste and excrement. Everybody eats and everybody poops. Moreover, the animals we raise for food also generate an enormous amount of waste. Methane, a byproduct from the decomposition of organic matter such as excrement, acts as a greenhouse gas if released into the atmosphere before being burned. Compared to CO2, methane is 25 times as powerful as a greenhouse gas. Anaerobic digesters use microbes to break down organic waste to produce methane (referred to as biogas) which is then burned to generate electricity.

This is not a novel concept either. Some cities and farms have already taken steps to implement anaerobic digesters for harnessing biogas from sewage and manure. States like Connecticut and New York already implement biogas programs, and many dairy farms across the nation have anaerobic digesters that produce methane from manure. A town in Colorado even powers vehicles using poop . . . yes, you read that correctly.

However, across the country the potential of biogas has not yet been fully realized, meaning there is still a large amount of methane escaping into the atmosphere as a greenhouse gas that could instead be captured and transformed into electricity. The American Biogas Council states that there are currently over 2,200 biogas production sites across the U.S. with the potential for an estimated 14,958 additional sites “ripe for development.”

The biggest barriers to widespread implementation of biogas production stem from a combination of economic feasibility, infrastructure, and lack of political support. Biodigesters can require a large capital investment to setup with financial benefits not being immediately realized. Additionally, while wastewater treatment plants and landfills have existing infrastructure better suited for conversion to biogas production and utilization, rural farms would need either pipes to move the gas or connection to the electrical grid to sell back the generated electricity. Without the necessary political support, in the form of government programs financially incentivizing anaerobic digestion, these issues will continue to act as a deterrent.

Federal eye on Biogas:

While the recent executive orders dealing with the climate crisis do mention mitigating methane emissions, the focus is instead on mining in the oil and gas sectors and not repurposing existing organic matter. It seems then that in our nation’s quest to go green we are overlooking the potential to transform the very waste we create. With food waste constituting the second largest category of solid waste sent to landfills, and cities producing millions of tons of sewage annually, implementing anaerobic digesters would provide numerous environmental advantages. They save landfill space, prevent methane from leaking into the atmosphere, and generate electricity reducing our reliance on other forms of electrical generation.

Fortunately, the EPA recognizes the value in biogas production and, if Biden’s proposed $14 billion in spending towards climate change materializes, the EPA may be able to allocate some of that funding towards developing new sites. When creating new laws and policies aimed at climate change perhaps it is best to always keep in mind the universal law of conservation of energy. Energy is neither created nor destroyed, but rather transformed; what we flush down the drain or discard as trash still has energy and it is up to us to utilize it.

 

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

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

Ian Colby, MJLST Staffer

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

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

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

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

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

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

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

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

 

You Gotta Fight for Your Right to Repair

April 4, 2021
Corporate Ethics, Public Health, Regulatory

Christopher Cerny, MJLST Staffer

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

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

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

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

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

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

“Crunch”Ing the Numbers Behind a Marquee Year in Video Games

April 4, 2021
Employment Law, Video Games

Ellie Soskin, MJLST Staffer

The COVID-19 pandemic has made this past year a financially devastating one for film and for sports, industries that rely on in-person ticket sales for a share of their revenue. But while those industries struggled, another form of entertainment was having a banner year. The videogame industry saw revenues reach a whopping $180 billion USD, by one estimate. As of last year, more than 214 million people in the United States alone reported playing some form of videogame for at least one hour per week. Four of five U.S. consumers reported playing a video game in the last six months. And with pandemic restrictions limiting activities, gaming on dedicated game consoles, on computers, and on smartphones (“mobile gaming”) has skyrocketed. For many, online gaming has provided a social outlet during a period of isolation, or an almost therapeutic form of escapism. But for all of the potential in the videogame industry, both economic and otherwise, there is a looming labor (and moral) issue that has escaped the law.

The Washington Post recently published a piece on the legality of what’s known in the gaming industry as “crunch.” Generally, crunch, short for “crunch time” occurs at the end of a game’s development cycle. As deadlines loom, the hours become longer and longer and every day becomes a workday; thirteen hour days and seven day workweeks are not remotely unheard of. Ultimately, though, crunch can occur any time there is a major development milestone looming, not just the end of a project.

This is not a new problem, with reports of crunch at major game developers and publishers like Electronic Arts (EA) dating back seventeen years. Back then, video game revenue sat at a relatively miniscule $7 billion annually, a mere 3 percent of where it is today. That explosion in revenue has not changed employment habits. As the Washington Post reports, a 2019 survey revealed that “40 percent of game developers reported working crunch time at least once over the course of the previous year,” with many working “at least 20 extra hours” per workweek and only 8 percent reporting overtime pay. The reports have been consistent over the years: one developer reported working “14 hours a day, six days a week” during a crunch period in 2016. In 2018, employees at major game development studio Rockstar reported an average of 60-hour weeks during crunch (generally six days of ten hour workdays); Rockstar co-founder Dan Houser described “100-hour weeks.” Those kinds of working conditions are a breeding ground for prolonged stress and fatigue, causing mental health issues and even actual physical illness.

News outlets have generally framed crunch as an industry problem without mind for the legal analysis. Publishers demand last minute changes, and studio heads push workers into crunch to appease their financial backers. Or it’s viewed as a rite of passage within the industry and just part of working what is a dream job for a number of young people. In the words of one employee, “[e]mployers know that it’s many people’s dream to be there, so they are able to exploit the fact.” Take This is a mental health non-profit focused on the gaming industry that published a white paper in 2019 reporting on the most pressing mental health issues faced by game developers. Career instability, particularly crunch and lack of job security, were found to be key drivers of poor mental health in developers. Additionally, developers report working for an average of 2.2 employers over a five year period, indicative of the low stability afforded by the industry.

The Washington Post’s piece is admittedly one of the first to focus on the legal framework enabling this kind of employment behavior in the United States. In sum, the video game industry has either exploited existing overtime exemptions for salaried employees under the FLSA and state law or lobbied for new exemptions. For example, after that aforementioned EA crunch exposé, employees sued and settled multiple multi-million dollar class action lawsuits over working conditions. The settlements would have limited the exemptions and reclassified certain employees as overtime eligible, had a new set of exemption rules not been enacted in 2008, lowering the point at which salaried employees are no longer considered eligible for overtime pay.

Crunch as a concept is not simply a United States video game industry problem. Crunch, particularly uncompensated crunch, is also a noted problem in Japanese studios, as well as in various studios worldwide. Polish video game studio CD Projekt Red (CDPR) made six-day workweeks mandatory in the weeks leading up to the highly anticipated release of their big-budget game “Cyberpunk 2077.” Notably, however, those employees all received paid overtime in accordance with Polish labor laws, as well as splitting 10% of the company’s 2020 profits amongst employees as a bonus.

Ultimately, crunch seems to be deeply embedded in the culture of the video game industry worldwide. But there’s no doubt that, as the Washington Post states, it has been enabled by the structure of current labor laws in the United States. Some industry insiders have floated unionization for developers as a potential solution to the lack of legal protections overall, particularly the lack of overtime, poor working conditions, and overall job instability. An industry survey from early 2020 indicated that, when asked if they should unionize, 54 percent of workers said yes, though only 23 percent believed that they actually would unionize. Last January, one of the biggest unions in the United States, Communications Workers of America (CWA), announced their intention to help game workers unionize. But it remains to be seen if anything will come of that and no new reports on unionization have emerged since the beginning of the COVID-19 pandemic. For now, it seems like it’s business as usual for a booming industry.

In the interest of full disclosure, this author’s brother works in the video game industry.

#IsTheShipStillStuck?

April 4, 2021
Economy, Litigation

Schuyler Troy, MJLST Staffer

The Ever Given, a massive four-hundred-meter-long cargo ship weighing over two hundred thousand tons and carrying over eighteen thousand cargo containers, ran aground in the Suez Canal on March 23, 2021. Wedged between the edges of the canal, the ship blocked all transport through the canal for just over six days. Trade routes were brought to a screeching halt as a backlog of hundreds of ships were left stranded in Egypt’s Great Bitter Lake waiting for passage through the canal, which serves as a conduit for about thirty percent of daily global shipping container volumes, including roughly one million barrels of oil a day. After days of round-the-clock work, the Ever Given was finally pried loose on March 29, allowing traffic to flow again through the canal. The precise cost of the trade stoppage is still unclear, but data from Lloyd’s List showed that the ship held up an estimated $9.6 billion in trade each day that it was stuck—roughly $400 million per hour. The canal itself generated $5.6 billion for Egypt in 2020.

What exactly caused the Ever Given to run aground is currently under investigation. According to an article from Business Insider, initial theories suggested that sudden strong winds caused the hull to deviate from its course and hit the bottom of the canal. Human error is also suspected to have played a part in the fiasco, with reports that the ship was traveling faster than the canal’s speed limit and that its crew opted not to utilize a tugboat escort through the canal. Investigators are also likely to scrutinize the performance of the Ever Given’s two Egyptian canal pilots, both senior chief pilots with more than thirty years of experience.

With so much money on the line, attention will surely turn to who will be left liable for the losses, and the complex structure of ownership and operation of the Ever Given has revealed a tangled web of potentially liable parties. The ship is owned by Shoei Kisen Kaisha, a Japanese subsidiary of Imabari Shipbuilding. At the time it ran aground in the Suez Canal, it was chartered and operated by Evergreen Marine, a Taiwanese container line. The Ever Given is registered in Panama, and is technically managed by the German ship management company Bernhard Schulte Shipmanagement. The crew was comprised of twenty-five Indian citizens, and the ship was insured in part by the UK P&I Club, a United Kingdom based insurance group.

Aggrieved parties are likely to raise claims arising not only from delays in shipment of the goods aboard the Ever Given, but also from cargoes on other ships that were delayed due to inability to transit the canal and from ships which diverted their course around the Cape of Good Hope, a longer and costlier route. There could also be claims for damage to the canal itself, as diggers were required to remove earth and rock from the canal’s banks around the areas where the ship ran aground.

Litigation over the Ever Given’s grounding will likely take years to sort out. In the meantime, we will always have the memes that the fiasco spawned.

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