Administrative Law

Watching an APA Case Gestate Live!

October 25, 2020
Administrative Law, Internet, Social Media

Parker von Sternberg, MJLST Staffer

On October 15^th the FCC published an official Statement of Chairman Pai on Section 230. Few particular statutes have come under greater fire in recent memory than the Protection for “Good Samaritan” Blocking and Screening of Offensive Material and the FCC’s decision to wade into the fray is almost certain to end up causing someone to bring suit regardless of which side of the issue the Commission comes down on.

As a brief introduction, 47 U.S. Code § 230 provides protections from civil suits for providers of Interactive Computer Services, which for our purposes can simply be considered websites. The statute was drafted and passed as a direct response by Congress to a pair of cases, namely Cubby, Inc. v. CompuServe Inc. and Stratton Oakmont, Inc. v. Prodigy Services Co.Cubby, Inc. v. CompuServe Inc., 776 F.Supp. 135 (S.D.N.Y. 1991) and Stratton Oakmont, Inc. v. Prodigy Services Co., 1995 WL 323710 (N.Y. Sup. Ct. 1995). Cubby held that the defendant, CompuServe, was not responsible for third-party posted content on its message board. The decisive reasoning by the court was that CompuServe was a distributor, not a publisher, and thus “must have knowledge of the contents of a publication before liability can be imposed.”Cubby, Inc. v. CompuServe Inc., 776 F.Supp. 135, 139 (S.D.N.Y. 1991). On the other hand, in Stratton Oakmont, the defendant’s exertion of “editorial control” over a message board otherwise identical to the one in Cubby “opened [them] up to a greater liability than CompuServe and other computer networks that make no such choice.” Stratton Oakmont, 1995 WL 323710 at *5.

Congress thus faced an issue: active moderation of online content, which is generally going to be a good idea, created civil liability where leaving message boards open as a completely lawless zone protects the owner of the board. The answer to this conundrum was § 230 which states, in part:

(c) Protection for “Good Samaritan” blocking and screening of offensive material

(1) Treatment of publisher or speaker

No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.

(2) Civil liability – No provider or user of an interactive computer service shall be held liable on account of—

(A) any action voluntarily taken in good faith to restrict access to or availability of material that the provider or user considers to be obscene, lewd, lascivious, filthy, excessively violent, harassing, or otherwise objectionable, whether or not such material is constitutionally protected . . . .

Judicial application of the statute has so far largely read the language expansively. Zeran v. AOL held that “[b]y its plain language, § 230 creates a federal immunity to any cause of action that would make service providers liable for information originating with a third-party user of the service.”Zeran v. Am. Online, Inc., 129 F.3d 327, 330 (4th Cir. 1997). The court also declined to recognize a difference between a defendant acting as a publisher versus a distributor. Speaking to Congress’s legislative intent, the court charted a course that aimed to both immunize service providers as well as encourage self-regulation. Id. at 331-334. Zeran has proved immensely influential, having been cited over a hundred times in the ensuing thirteen years.

Today however, the functioning of § 230 has become a lightning rod for the complaints of many on social media. Rather than encouraging interactive computer services to self-regulate, the story goes that it instead protects them despite their “engaging in selective censorship that is harming our national discourse.” Republicans in the Senate have introduced a bill to amend the Communications Decency Act specifically to reestablish liability for website owners in a variety of ways that § 230 currently protects them from. The Supreme Court has also dipped its toes in the turbulent waters of online censorship fights, with Justice Thomas saying that “courts have relied on policy and purpose arguments to grant sweeping protection to Internet platforms” and that “[p]aring back the sweeping immunity courts have read into §230 would not necessarily render defendants liable for online misconduct.”

On the other hand, numerous private entities and individuals hold that § 230 forms part of the backbone of the internet as we know it today. Congress and the courts, up until a couple of years ago, stood in agreement that it was vitally important to draw a bright line between the provider of an online service and those that used it. It goes without saying that some of the largest tech companies in the world directly benefit from the protections offered by this law, and it can be argued that the economic impact is not limited to those larger players alone.

What all of this hopefully goes to show is that, no matter what happens to this statute, someone somewhere will be willing to spend the time and the money necessary to litigate over it. The question is what shape that litigation will take. As it currently stands, the new bill in the Senate has little chance of getting through the House of Representatives to the President’s desk. The Supreme Court just recently denied cert to yet another § 230 case, upholding existing precedent. Enter Ajit Pai and the FCC, with their legal authority to interpret 47 U.S. Code § 230. Under the cover of Chevron deference protecting administrative action with regard to interpreting statutes the legislature has empowered them to enforce, the FCC wields massive influence with regard to the meaning of § 230. Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).

While the FCC’s engagement is currently limited to a statement that it intends to “move forward with rulemaking to clarify [§ 230’s] meaning,” there are points to discuss. What limits are there on the power to alter the statute’s meaning? Based on the Commissioner’s statement, can we tell generally what side they are going to come down on? With regard to the former, as was said above, the limit is set largely by Chevron deference and by § 706 of the APA. The key words here are going to be if whoever ends up unhappy with the FCC’s interpretation can prove that it is “arbitrary and capricious” or goes beyond a “permissible construction of the statute.” Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).

The FCC Chairman’s statement lays out that issues exist surrounding §230 and establishes that the FCC believes the legal authority exists for it to interpret the statute. It finishes by saying “[s]ocial media companies have a First Amendment right to free speech. But they do not have a First Amendment right to a special immunity denied to other media outlets, such as newspapers and broadcasters.” Based on this statement alone, it certainly sounds like the FCC intends to narrow the protections for interactive computer services providers in some fashion. At the same time, it raises questions. For example, does § 230 provide websites with special forms of free speech that other individuals and groups do not have? The statute does not on its face make anything legal that without it would not be. Rather, it ensures that legal responsibility for speech lies with the speaker, rather than the digital venue in which it is said.

The current divide on liability for speech and content moderation on the internet draws our attention to issues of power as the internet continues to pervade all aspects of life. When the President of the United States is being publicly fact-checked, people will sit up and take notice. The current Administration, parts of the Supreme Court, some Senators, and now the FCC all appear to feel that legal proceedings are a necessary response to this happening. At the same time, alternative views do exist outside of Washington D.C., and at many points they may be more democratic than those proposed within our own government.

There is a chance that if the FCC takes too long to produce a “clarification” of §230 that Chairman Pai will be replaced after the upcoming Presidential election. Even if this does happen, I feel that the outlining of the basic positions surrounding this statute is nonetheless worthwhile. A change in administrations simply means that the fight will occur via proposed statutory amendments or in the Supreme Court, rather than via the FCC.

Extracting Favors: Fossil-Fuel Companies Are Using the Pandemic to Lobby for Regulatory Rollbacks and Financial Bailouts

October 17, 2020
Administrative Law, Climate Change, COVID-19, Energy Law, Environmental Law

Christopher Cerny, MJLST Staffer

In the waning months of World War II, Winston Churchill is quoted, perhaps apocryphally, as saying, “[n]ever let a good crisis go to waste.” It seems fossil-fuel companies have taken these words to heart. While in the midst of one of the greatest crises of modern times, oil, gas, and coal companies are facing tremendous economic uncertainty, not only from the precipitous drop in demand for gasoline and electricity, but also from the rise of market share held by renewable energy. In response, industry trade groups and the corporations they represent are engaged in an aggressive lobbying campaign aimed at procuring financial bailouts and regulatory rollbacks. The federal government and some states seem inclined to provide assistance, but with the aforementioned rise of renewable energy, many see the writing on the wall for some parts of the fossil-fuel industry.

The ongoing COVID-19 pandemic continues to inflict immeasurable havoc on a global scale. The virus and the mitigation efforts designed to curb its spread have dramatically changed the way humankind interacts with each other and the world around us. In the United States, nearly all states at one time or another implemented mandatory shelter-at-home orders to restrict movement and prevent the further spread of the novel coronavirus. These orders have, in many ways, completely restructured society and the economy, with perhaps no sector being more impacted than transportation. At the peak of the virus in the United States, air travel was down 96% and, in April 2020, passenger road travel was down 77% from 2019. Similarly, the pandemic has altered America’s energy consumption. For example, the Midcontinent Independent System Operator reports a decrease in daily weekday demand in March and April of up to 13% and a national average decline of as much as 7% for the same time frame. A secondary impact of these market disruptions is on the fossil-fuel industry. The decrease in electricity demand has further diminished the already declining coal market, while the fall off in travel and transportation has radically impacted oil prices.

On April 20, a barrel of oil traded for a loss for the first time ever when demand fell so low that the cost storing oil exceeded its sale price. While the price of a barrel of oil, the world’s most traded commodity, has since improved, as of October 1st, the U.S. stock index for domestic oil companies remains down 57% in 2020. Similarly, coal consumption in the United States is projected to decline 23% this year. Natural gas remains resilient, with U.S. demand only dropping 2.8% between January and May of 2020. However, much of natural gas’s buoyancy comes at the expense of lower prices. These numbers are dire, especially for coal and oil, two domestic industries already on the decline due to the rise in renewable energy.

Fossil-fuel companies have gone on the offensive. The oil and gas industry is responding to these calamitous figures and grim financials by lobbying state and federal lawmakers for financial bailouts and the relaxation of environmental regulations. The California Independent Petroleum Association, an oil and gas trade group, requested an extension for compliance with an idle well testing plan that would push 100% program compliance from 2025 to 2029. Further, the trade group asked California to scale back on Gov. Gavin Newsom’s plan to increase the staff of the California Energy Management Division, the state agency charged with oversight of oil and gas drilling. In Texas, the Blue Ribbon Task Force on Oil Economic Recovery, created at the behest of the state oil and gas regulatory body and composed of representatives and leaders of Texas’s oil and gas trade groups, recommended the suspension of particular environmental testing and extensions for environmental reporting to the state agency. The Louisiana Oil and Gas Association asked Louisiana Gov. John Bel Edwards to suspend the state’s collection of severance taxes.

On the national stage, the Independent Petroleum Association of America asked the Chairman of the Federal Reserve to support changes to the Main Street Lending Program, a part of the CARES Act, to expand the eligibility requirements to include many oil and gas producers. The American Fuel and Petrochemical Manufacturers, a refiners trade association, called on the Trump administration and the Environmental Protection Agency (EPA) to waive biofuel policies that mandate the blending of renewable corn-derived ethanol in petroleum refining. The American Petroleum Institute also reached out to the Trump administration seeking the waiver of record keeping and training compliance.

Not to be left behind, the coal industry ramped up its lobbying as well. In an opinion piece, the CEO of America’s Power, a coal trade group extolled the virtues of the fleet of coal power plants and their necessity in the recovery from the COVID-19 pandemic. The National Mining Congress, the coal industry’s lobbying arm, sent a letter to the Trump administration and Congressional leaders asking for an end to the industry’s requirements to pay into funds for black lung disease and polluted mine clean-up

These lobbying efforts are being met with varied levels of success. In a move that garnered criticism from the Government Accountability Office, the Department of the Interior through the Bureau of Land Management cut royalties on oil and gas wells leased by the federal government, saving the industry $4.5 million. The EPA scaled back enforcement of pollution rules, instead relying on companies to monitor themselves. The Governors of Texas, Utah, Oklahoma, and Wyoming sent a letter asking the EPA to waive the biofuel blending regulations in support of the refiners trade group. In September, the EPA denied the request. The Governor of Louisiana agreed to delay the collection of the severance tax, a revenue source for the state that can normally bring in $40 million per month. The Louisiana state legislature later voted to reduce the severance tax on oil and gas from 12.5% to 8.5% for the next eight years. The EPA finalized a rule that it is not “appropriate and necessary” to regulate certain hazardous air pollutants, including mercury, emitted from coil and oil fired power plants.

It is difficult to discern what impact these industry efforts and resulting government actions will have in the long term. The financial measures may have propped up an industry that otherwise would have suffered permanent damage and bankruptcies without the influx of relief and capital. However, environmental groups are more concerned with the regulatory rollbacks. For example, after the EPA chose to allow companies to self-monitor pollution, there was a year-over-year decline of 40% in air emissions tests at industrial facilities and over 16,500 facilities did not submit required water quality reports. The ramifications of the state and federal acquiescence to the fossil-fuel industry’s requested regulatory non-compliance may end up costing the American tax payers millions of dollars, causing irreparable immediate harm to the environment, and delaying critical action needed to mitigate anthropogenic climate change.

COVID-19, Remote Technology, and Due Process in Administrative HearingsBrent

May 13, 2020
Administrative Law, COVID-19, New Technology

Brent Murcia, MJLST Staffer

Wherever you look, it seems like COVID-19 is dominating all the headlines these days (even this blog!)—and with good reason. The pandemic is a public health crisis on a massive scale, forcing all of us to change our lives to “socially distance” and help “flatten the curve.”

As of April 7, 95% of Americans were under some sort of “stay at home” order. With life-as-usual on hold, many people are turning to technology to keep things running. For example, in Boston, some celebrated St. Patrick’s Day with virtual concerts. Some people celebrated Earth Day by tuning into National Park webcams. And of course, everyone from Minnesota Law students to the UK Cabinet is holding meetings (and happy hours!) on Zoom.

The legal system, of course, is not immune from the effects of this pandemic. Staff at government agencies, private law firms, and nonprofits are working from home. Some state legislatures are allowing remote voting for the first time. Many prisons have suspended in-person visits, including legal visits. Courts across the country are closed, delayed, or operating remotely. In section 150002 of the recent COVID-19 relief bill (the “CARES Act”), Congress authorized emergency video and telephone hearings for a variety of court proceedings, including detention hearings and felony pleas and sentencing. Even the United States Supreme Court will be moving to argument over the phone in May.

As with many things in society these days, a number of these changes would have been unthinkable two months ago. Who could have imagined that certain courts, many of which require paper filings and ban the use of electronic devices in courtrooms, would soon holdarguments via video conference? The Supreme Court itself has famously never allowed live broadcasts of arguments (a subject of considerable debate). But with arguments moving to the phone, the Court will now allow the public to listen in real time.

As one would expect, the rollout of these sudden changes has not been entirely smooth. In many courts, things have gone well, with only “momentary audio hiccups and minor glitches.” But in March, a D.C. Circuit judge was dropped from an argument and missed several minutes. Last week, a Florida judge complained of lawyers making court appearances shirtless or in pajamas. One Australian barrister described remote court hearings as follows: “The judge couldn’t see anyone; lines dropped out regularly; witnesses didn’t know where to go; … subpoenaed material could not be accessed by anyone; feedback made it impossible to proceed.”

Some of these problems are silly—in the grand scheme of things, we have bigger worries than appropriate Zoom dress codes. But others have the potential to fundamentally impact proceedings—possibly affecting parties’ due process rights. This blog post briefly explores some of the issues that COVID-19 has brought to the forefront, with a particular focus on administrative processes. (For a comprehensive listing of the ways in which different federal administrative agencies are holding their hearings, see this great blog post from the Yale Journal on Regulation).

Remote Hearings—An Overview

Remote proceedings are not exactly new. Even before the pandemic took hold, CourtCall—a company that facilitates remote appearances—had hosted six million such appearances since 1996. Many courts have long allowed certain remote appearances (sometimes requiring the consent of the parties, sometimes not). According to the Administrative Conference of the United States (ACUS), some agencies already conducted thousands of video hearings a year even before the pandemic. Still, until recently, such appearances were the exception, not the norm. And the use of remote technologies has generated controversy, even before its sudden widespread adoption.

Problems with Remote Hearings

Some people have expressed skepticism about the use of remote hearings, emerging in part from evidentiary concerns. As the BBC recently reported, video calls can make it “harder to process non-verbal cues like facial expressions, the tone and pitch of the voice, and body language.” That BBC story also referred to a 2014 study which found that even a 1.2 second transmission delay on a videoconferencing system “made people perceive the responder as less friendly or focused.” These effects can matter, considering the importance of perception and non-verbal cues in courtrooms. Additionally, one 1996 study in the University of Michigan Journal of Law Reform (before the advent of video technology) found that “parties to telephone hearings are less likely to exercise their rights to submit evidence through witnesses and documents than are parties to in-person hearings.”

Remote hearings can be particularly problematic in immigration hearings, which often involve language interpretation and the recounting of traumatic events. In early March—even before COVID-19 closures began—immigration courts in Texas began a pilot program to hold more hearings for unaccompanied children over videoconference, attempting to reduce a backlog of cases. One immigration attorney, forced by the virus to work with clients remotely, described the difficulty of doing so: “[w]e’re asking kids to open up and talk about the most personal and traumatic experiences of their lives and not even be making direct eye contact with them.” Remote hearings can affect the outcome of cases; a 2017 Government Accountability Office (GAO) study found that video hearings caused difficulties with language interpretation and affected immigration judges’ assessments of respondents’ credibility. A study in the Northwestern University Law Review found that respondents in video hearings were more likely to be deported. The American Immigration Lawyers Association opposes the use of video hearings for immigration for these reasons.

Problems with remote hearings also arise in settings that require public participation—like rulemakings and permit applications. In Minnesota, for instance, the state Pollution Control Agency (MPCA) recently delayed publication of a proposed Clean Cars rule, recognizing the importance of in-person comment and“ensuring that the public has opportunity to participate in the rule-making process.” At the same time, the MPCA moved forward with public meetings about Clean Water Act permits for the controversial Line 3 pipeline project, holding the meetings over the phone. More than 1,600 people called into the meetings, but only 400 were able to speak due to high volume. Some local organizers collected video comments, attempting to put a face to the public input, and called for the agency to hold in-person meetings once the pandemic has passed.

Finally, depending on the circumstances, remote hearings can also run afoul of specific public process requirements and open meeting laws. Lawyers in New Jersey, for instance, have highlighted a number of legal concerns arising from virtual land use board hearings. Laws about when and how meetings may be held electronically vary state to state; and amidst the pandemic, governors and legislatures have taken varying steps to clarify that authority. In Minnesota, the state legislature amended the open meeting law to account for the pandemic, expanding the circumstances under which meetings may be held remotely.

Benefits of Remote Hearings

Despite all of these problems, some lawyers have actually long advocated for an increase in virtual hearings. One common argument is that online hearings can help improve access to justice, addressing backlogs of millions of cases in some courts and agencies. Some argue that our current legal process is built more around “serving a place than serving justice.” One paper surveyed a number of other reasons why remote hearings may help in some contexts. Remote hearings can help in international cases or cases where the parties and witnesses live far apart; they can help with safety and security for parties, witnesses, and judges; they can help alleviate scheduling issues; and they can help in cases where traveling to court presents a significant burden for an individual, perhaps for economic reasons or due to a disability. (For a thorough summary of some of the ways in which technology—not just remote hearings—can help improve access to justice, see this 2012 article in the Harvard Journal of Law & Technology).

Further, while some arguments against remote hearings focus on the importance of non-verbal cues in proceedings, others have disputed that importance. Some research has pointed out that there can be as much pseudoscience as science in attempts to interpret witness behavior. Some have questioned whether witness demeanor is even useful at all for assessing credibility. And while non-verbal cues can and do shape judge and jury reactions, this may not always be a good thing—reactions to certain behaviors can be shaped by implicit bias, furthering racial and other disparities. More research is likely needed on whether these disparities are exacerbated or lessened by different types of virtual hearings.

Finally, remote court hearings can create significant cost savings. For example, according to ACUS, the Social Security Administration’s Office of Disability Adjudication and Review saved $59 million in 2010 from using video hearings. These savings matter to people who have to navigate the legal system. A 2014 NPR investigation found, for example, that “the costs of the criminal justice system in the United States are paid increasingly by the defendants and offenders.” Many defendants are required to pay hundreds or thousands of dollars in court costs, even for constitutionally required services. Reducing court costs could help lower fees, reducing the burden on low-income parties. Additionally, law firms are saving money from virtual hearings too, potentially reducing the cost of legal services and improving access to representation down the road.

The potential for improved access and reduced costs from virtual hearings is promising, but comes with an important caution. As British lawyer Richard Atkinson wrote for The Guardian in 2012: “A more efficient justice system is possible, but the government needs to recognise that speed does not always equate to efficiency and efficiency should never be promoted over justice.”

Looking Forward

As the effects of social distancing wear on, many of us look forward to the day when we can finally go “back to normal.” Without question, it will be a happy day when we can be with our loved ones, our friends, and our coworkers again. Lawyers will also be happy to return to the office, meet with clients in person, and advocate in real courtrooms.

At the same time, questions about remote hearings will not go away. Looking backward, some litigators will likely contest whether certain remote hearings conducted during COVID-19 were permissible. Looking forward, others will use our social distancing experience to argue that we should expand or reduce the use of remote hearings in the future.

There are no universal answers to these questions—the appropriateness of remote hearings depends on the applicable laws and the context of the case. In some cases, remote hearings can adversely affect parties’ rights; in others, they can actually improve access to justice. As one English judge wrote recently, “[i]t remains the obligation of all involved and at all stages of the hearing, to continue to evaluate whether fairness to all the parties is being achieved. Fairness cannot be sacrificed to convenience.” Our task, in these unprecedented times, is to move forward as best and as fairly we can—and to learn from these new experiences to better inform our approach to technology in the courtroom in the future.

COVID-19, Remote Technology, and Due Process in Administrative Hearings

May 13, 2020
Administrative Law, COVID-19, New Technology

Brent Murcia, MJLST Staffer

Wherever you look, it seems like COVID-19 is dominating all the headlines these days (even this blog!)—and with good reason. The pandemic is a public health crisis on a massive scale, forcing all of us to change our lives to “socially distance” and help “flatten the curve.”

As of April 7, 95% of Americans were under some sort of “stay at home” order. With life-as-usual on hold, many people are turning to technology to keep things running. For example, in Boston, some celebrated St. Patrick’s Day with virtual concerts. Some people celebrated Earth Day by tuning into National Park webcams. And of course, everyone from Minnesota Law students to the UK Cabinet is holding meetings (and happy hours!) on Zoom.

The legal system, of course, is not immune from the effects of this pandemic. Staff at government agencies, private law firms, and nonprofits are working from home. Some state legislatures are allowing remote voting for the first time. Many prisons have suspended in-person visits, including legal visits. Courts across the country are closed, delayed, or operating remotely. In section 150002 of the recent COVID-19 relief bill (the “CARES Act”), Congress authorized emergency video and telephone hearings for a variety of court proceedings, including detention hearings and felony pleas and sentencing. Even the United States Supreme Court will be moving to argument over the phone in May.

As with many things in society these days, a number of these changes would have been unthinkable two months ago. Who could have imagined that certain courts, many of which require paper filings and ban the use of electronic devices in courtrooms, would soon holdarguments via video conference? The Supreme Court itself has famously never allowed live broadcasts of arguments (a subject of considerable debate). But with arguments moving to the phone, the Court will now allow the public to listen in real time.

As one would expect, the rollout of these sudden changes has not been entirely smooth. In many courts, things have gone well, with only “momentary audio hiccups and minor glitches.” But in March, a D.C. Circuit judge was dropped from an argument and missed several minutes. Last week, a Florida judge complained of lawyers making court appearances shirtless or in pajamas. One Australian barrister described remote court hearings as follows: “The judge couldn’t see anyone; lines dropped out regularly; witnesses didn’t know where to go; … subpoenaed material could not be accessed by anyone; feedback made it impossible to proceed.”

Some of these problems are silly—in the grand scheme of things, we have bigger worries than appropriate Zoom dress codes. But others have the potential to fundamentally impact proceedings—possibly affecting parties’ due process rights. This blog post briefly explores some of the issues that COVID-19 has brought to the forefront, with a particular focus on administrative processes. (For a comprehensive listing of the ways in which different federal administrative agencies are holding their hearings, see this great blog post from the Yale Journal on Regulation).

Remote Hearings—An Overview

Remote proceedings are not exactly new. Even before the pandemic took hold, CourtCall—a company that facilitates remote appearances—had hosted six million such appearances since 1996. Many courts have long allowed certain remote appearances (sometimes requiring the consent of the parties, sometimes not). According to the Administrative Conference of the United States (ACUS), some agencies already conducted thousands of video hearings a year even before the pandemic. Still, until recently, such appearances were the exception, not the norm. And the use of remote technologies has generated controversy, even before its sudden widespread adoption.

Problems with Remote Hearings

Some people have expressed skepticism about the use of remote hearings, emerging in part from evidentiary concerns. As the BBC recently reported, video calls can make it “harder to process non-verbal cues like facial expressions, the tone and pitch of the voice, and body language.” That BBC story also referred to a 2014 study which found that even a 1.2 second transmission delay on a videoconferencing system “made people perceive the responder as less friendly or focused.” These effects can matter, considering the importance of perception and non-verbal cues in courtrooms. Additionally, one 1996 study in the University of Michigan Journal of Law Reform (before the advent of video technology) found that “parties to telephone hearings are less likely to exercise their rights to submit evidence through witnesses and documents than are parties to in-person hearings.”

Remote hearings can be particularly problematic in immigration hearings, which often involve language interpretation and the recounting of traumatic events. In early March—even before COVID-19 closures began—immigration courts in Texas began a pilot program to hold more hearings for unaccompanied children over videoconference, attempting to reduce a backlog of cases. One immigration attorney, forced by the virus to work with clients remotely, described the difficulty of doing so: “[w]e’re asking kids to open up and talk about the most personal and traumatic experiences of their lives and not even be making direct eye contact with them.” Remote hearings can affect the outcome of cases; a 2017 Government Accountability Office (GAO) study found that video hearings caused difficulties with language interpretation and affected immigration judges’ assessments of respondents’ credibility. A study in the Northwestern University Law Review found that respondents in video hearings were more likely to be deported. The American Immigration Lawyers Association opposes the use of video hearings for immigration for these reasons.

Problems with remote hearings also arise in settings that require public participation—like rulemakings and permit applications. In Minnesota, for instance, the state Pollution Control Agency (MPCA) recently delayed publication of a proposed Clean Cars rule, recognizing the importance of in-person comment and“ensuring that the public has opportunity to participate in the rule-making process.” At the same time, the MPCA moved forward with public meetings about Clean Water Act permits for the controversial Line 3 pipeline project, holding the meetings over the phone. More than 1,600 people called into the meetings, but only 400 were able to speak due to high volume. Some local organizers collected video comments, attempting to put a face to the public input, and called for the agency to hold in-person meetings once the pandemic has passed.

Finally, depending on the circumstances, remote hearings can also run afoul of specific public process requirements and open meeting laws. Lawyers in New Jersey, for instance, have highlighted a number of legal concerns arising from virtual land use board hearings. Laws about when and how meetings may be held electronically vary state to state; and amidst the pandemic, governors and legislatures have taken varying steps to clarify that authority. In Minnesota, the state legislature amended the open meeting law to account for the pandemic, expanding the circumstances under which meetings may be held remotely.

Benefits of Remote Hearings

Despite all of these problems, some lawyers have actually long advocated for an increase in virtual hearings. One common argument is that online hearings can help improve access to justice, addressing backlogs of millions of cases in some courts and agencies. Some argue that our current legal process is built more around “serving a place than serving justice.” One paper surveyed a number of other reasons why remote hearings may help in some contexts. Remote hearings can help in international cases or cases where the parties and witnesses live far apart; they can help with safety and security for parties, witnesses, and judges; they can help alleviate scheduling issues; and they can help in cases where traveling to court presents a significant burden for an individual, perhaps for economic reasons or due to a disability. (For a thorough summary of some of the ways in which technology—not just remote hearings—can help improve access to justice, see this 2012 article in the Harvard Journal of Law & Technology).

Further, while some arguments against remote hearings focus on the importance of non-verbal cues in proceedings, others have disputed that importance. Some research has pointed out that there can be as much pseudoscience as science in attempts to interpret witness behavior. Some have questioned whether witness demeanor is even useful at all for assessing credibility. And while non-verbal cues can and do shape judge and jury reactions, this may not always be a good thing—reactions to certain behaviors can be shaped by implicit bias, furthering racial and other disparities. More research is likely needed on whether these disparities are exacerbated or lessened by different types of virtual hearings.

Finally, remote court hearings can create significant cost savings. For example, according to ACUS, the Social Security Administration’s Office of Disability Adjudication and Review saved $59 million in 2010 from using video hearings. These savings matter to people who have to navigate the legal system. A 2014 NPR investigation found, for example, that “the costs of the criminal justice system in the United States are paid increasingly by the defendants and offenders.” Many defendants are required to pay hundreds or thousands of dollars in court costs, even for constitutionally required services. Reducing court costs could help lower fees, reducing the burden on low-income parties. Additionally, law firms are saving money from virtual hearings too, potentially reducing the cost of legal services and improving access to representation down the road.

The potential for improved access and reduced costs from virtual hearings is promising, but comes with an important caution. As British lawyer Richard Atkinson wrote for The Guardian in 2012: “A more efficient justice system is possible, but the government needs to recognise that speed does not always equate to efficiency and efficiency should never be promoted over justice.”

Looking Forward

As the effects of social distancing wear on, many of us look forward to the day when we can finally go “back to normal.” Without question, it will be a happy day when we can be with our loved ones, our friends, and our coworkers again. Lawyers will also be happy to return to the office, meet with clients in person, and advocate in real courtrooms.

At the same time, questions about remote hearings will not go away. Looking backward, some litigators will likely contest whether certain remote hearings conducted during COVID-19 were permissible. Looking forward, others will use our social distancing experience to argue that we should expand or reduce the use of remote hearings in the future.

There are no universal answers to these questions—the appropriateness of remote hearings depends on the applicable laws and the context of the case. In some cases, remote hearings can adversely affect parties’ rights; in others, they can actually improve access to justice. As one English judge wrote recently, “[i]t remains the obligation of all involved and at all stages of the hearing, to continue to evaluate whether fairness to all the parties is being achieved. Fairness cannot be sacrificed to convenience.” Our task, in these unprecedented times, is to move forward as best and as fairly we can—and to learn from these new experiences to better inform our approach to technology in the courtroom in the future.

Zoinks! Can the FTC Unmask Advertisements Disguised by Social Media Influencers?

February 25, 2020
Administrative Law, Food and Drug Law, Social Media

Jennifer Satterfield, MJLST Staffer

Social media sites like Instagram and YouTube are filled with people known as “influencers.” Influencers are people with a following on social media that use their online fame to promote products and services of a brand. But, with all that power comes great responsibility, and influencers, as a whole, are not being responsible. One huge example of irresponsible influencer activity is the epic failure and fraudulent music festival known as Fyre Festival. Although Fyre Festival promised a luxury, VIP experience on a remote Bahamian island, it was a true nightmare where “attendees were stranded with half-built huts to sleep in and cold cheese sandwiches to eat.” The most prominent legal action was against Fyre’s founders and organizers, Billy McFarland and Ja Rule, including a six-year criminal sentence for wire fraud against McFarland. Nonetheless, a class action lawsuit also targeted the influencers. According to the lawsuit, the influencers did not comply with Federal Trade Commission (“FTC”) guidelines and disclose they were being paid to advertise the festival. Instead, “influencers gave the impression that the guest list was full of the Social Elite and other celebrities.” Yet, the blowback against influencers since the Fyre Festival fiasco appears to be minimal.

According to a Mediakix report, “[i]n one year, a top celebrity will post an average of 58 sponsored posts and only 3 may be FTC compliant.” The endorsement guidelines specify that if there is a “material connection” between the influencer and the seller of an advertised product, this connection must be fully disclosed. The FTC even created a nifty guide for influencers to ensure compliance. While disclosure is a small burden and there are several resources informing influencers of their duty to disclose, these guidelines are still largely ignored.

Evens so, the FTC has sent several warning letters to individual influencers over the years, which indicates it is monitoring top influencers’ posts. However, a mere letter is not doing much to stop the ongoing, flippant, and ignorant disregard toward the FTC guidelines. Besides the letters, the FTC rarely takes action against individual influencers. Instead, if the FTC goes after a bad actor, “it’s usually a brand that[] [has] failed to issue firm disclosure guidelines to paid influencers.” Consequently, even though it appears as if the FTC is cracking down on influencers, it is really only going after the companies. Without actual penalties, it is no wonder most influencers are either unaware of the FTC guidelines or continue to blatantly ignore them.

Considering this problem, there is a question of what the FTC can really do about it. One solution is for the FTC to dig in and actually enforce its guidelines against influencers like it did in 2017 with CSGO Lotto and two individual influencers, Trevor Martin and Thomas Cassell. CSGO Lotto was a website in which users could gamble virtual items called “skins” from the game Counter-Strike: Global Offensive. According to the FTC’s complaint, Martin and Thomas endorsed CSGO Lotto but failed to disclose they were both the owners and officers of the company. CSGO Lotto also paid other influencers to promote the website. The complaint notes that numerous YouTube videos by these influencers either failed to include a sponsorship disclosure in the videos or inconspicuously placed such disclosures “below the fold” in the description box. While the CSGO Lotto action was a huge scandal in the video game industry, it was not widely publicized to the general population. Moreover, Martin and Cassell got away with a mere slap on the wrist—“[t]he [FTC] order settling the charges requires Martin and Cassell to clearly and conspicuously disclose any material connections with an endorser or between an endorser and any promoted product or service.” Thus, it was not enough to compel other influencers into compliance. Instead, if the FTC started enforcement actions against big-name influencers, other influencers may also fear retribution and comply.

On the other hand, the FTC could continue its enforcement against the companies themselves, but this time with more teeth. Currently, the FTC is preparing to take further steps to ensure consumer protection in the world of social media influencers. Recently, FTC Commissioner Rohit Chopra acknowledged in a public statement that “it is not clear whether our actions are deterring misconduct in the marketplace, due to the limited sanctions we have pursued.” Although Chopra is not interested in pursuing small influencers, but rather the advertisers that pay them, it is possible that enforcement against the companies will cause influencers to comply as well.

Accordingly, Chopra’s next steps include: (1) “[d]eveloping requirements for technology platforms (e.g. Instagram, YouTube, and TikTok) that facilitate and either directly or indirectly profit from influencer marketing;” (2) “[c]odifying elements of the existing endorsement guides into formal rules so that violators can be liable for civil penalties under Section 5(m)(1)(A) and liable for damages under Section 19; 7;” and (3) “[s]pecifying the requirements that companies must adhere to in their contractual arrangements with influencers, including through sample terms that companies can include in contracts.” By pushing some of the enforcement duties onto social media platforms themselves, the FTC gains more monitoring and enforcement capabilities. Furthermore, codifying the guidelines into formal rules gives the FTC teeth to impose civil penalties and creates tangible consequences for those who previously ignored the guidelines. Finally, by actually requiring companies to adhere to these rules via their contract with influencers, influencers will be compelled to follow the guidelines as well. Therefore, under these next steps, paid advertising disclosures on social media can become commonplace. But only time will really tell if the FTC will achieve these steps.

Electric Scooter Regulations in Winter: Why the “Brake” in Service?

February 17, 2020
Administrative Law, Public Safety, Transportation

Warren Cormack, MJLST Staffer

In the summer of 2018, the city of Minneapolis began a pilot project to introduce 600 electric rental scooters, primarily to the downtown area. The city approved operations for Jump, Lyft, Spin, and Lime in 2019. Two thousand scooters were slated to hit the Minneapolis streets, but the companies deployed less than one thousand to Minneapolis for much of the 2019 season. Still, half a year ago, ride-share scooters from the 2019 authorization could be found all over the streets of Minneapolis and users “racked up about 225,000 rides.”

Minneapolis is a city with a strong winter biking tradition. Yet in February, with winter in full swing, electric scooters are nowhere to be seen. What happened?

The short answer is that Minneapolis’ second pilot program for electric scooters ended in November 2019. When we dig deeper, though, some interesting dynamics affect the use of electric scooters in winter.

Though scooter companies initially targeted warm-weather cities, now colder cities like Milwaukee, Boston, and Minneapolis face challenges associated with operating electric scooters in colder weather. For example, when snow emergencies hit, cities may have to ask companies to remove scooters from the roads.

An important concern for cities is safety. This was a major reason why Minneapolis ended the 2019 scooter pilot in late November. Minneapolis scooter companies agreed that 6 to 10 inches of snow was too much to operate safely. Scooter companies are already being sued for the injuries that they cause, and the odds that someone might injure themselves while riding on snowy ground is higher than when the streets are clear. Still, scooter companies have shown a desire to keep their scooters running unless a winter storm hits.

Though Denver’s weather is not as cold as Minneapolis, it does snow there. Denver’s scooters arrived in May 2018 and the city regulated their numbers within two months. Still, the city did not regulate the months within which the scooters would be available for use. A spokeswoman for Denver Public Works reportedly said: “I think riders are going to have to make their own choices if they want to ride an electric scooter in the winter months.” Denver’s comparable warmth may affect how the city balances safety concerns.

The cold weather is not only an issue for riders. “Scooter companies are still learning how their vehicles perform in various weather conditions and from regular use.” Scooters generally either operate on bike lanes or sidewalks. In either location, the small wheels and limited batteries of scooters can negatively impact their winter-weather suitability. The major scooter models currently in use have minimum operating temperatures of fourteen degrees Fahrenheit. Possibly in response to the limits of popular scooters, Bird (one of the major scooter companies) designed a scooter with more battery and pronounced tire treads. Tier is another company developing scooters that can handle cold weather. The effects of winter may be over-hyped, however. According to a scooter expert, scooters may become slower during the winter, but the cold does not damage their battery.

A final winter issue is simply a lack of riders. Even for European scooter companies that operate throughout the year, about half of the riders stop riding during the winter. Minneapolis data also reflect a roughly 50% decrease from summer’s peak to November. College riders leave home for winter break, prompting companies to reduce the number of deployed scooters. A lack of winter riders caused Lime to ramp down operations in Milwaukee. Though riders in relatively snowy cities like Denver have found that people use scooters through the winter, scooter companies facing higher maintenance costs and lower ridership may be wise to reduce their fleet size.

Scooters may leave for the winter due to safety, maintenance, or lower ridership. This may be caused by city policy or by the companies themselves. If the companies continue to make their scooters more capable of enduring the winter, cities may begin to find themselves at odds with electric scooter companies’ desire to stay open for business.

E-Bikes: Protections, Safety and Liability on the Road

February 7, 2020
Administrative Law, New Technology, Public Safety

Alex Wolf, MJLST Staffer

E-bikes, or electronic bikes, are kind of a hybrid between an electric scooter and a regular bicycle. In appearance, they’re no different than your normal two-wheeled bike, but e-bikes have a motor that lets the rider reach brisk speeds without much pedaling effort. There are two classes of motors, hub motors and mid-drive motors. Hub motors are installed in the hub gear and mid-drive motors are installed between the pedals at the bottom bracket of the bike. The usual advice for e-bike newbies is to start with a hub motor; it is simpler to install and it has fewer working parts (creating less risk of a slip/accident and lasting longer). However, the mid-drives have now outpaced the hubs in popularity; for biking enthusiasts, the gear shifts feel more natural and the extra power is great for terrain or mountain biking.

E-bikes are on the streets, so states and localities need to decide how to regulate them. Wisconsin Governor Tony Evers recently signed a law that incorporates e-bikes into an existing law governing safety regulations for bicycles. The law creates a three-tiered “e-bike class” system, based on the maximum speed the e-bike can reach with its motor. Although e-bike riders don’t need any license or permit to operate, riders must be 16 years or older to ride e-bikes that can reach 28 mph. These regulations are similar to those previously enacted in Illinois and Michigan.

Like electronic scooters, e-bikes pose more safety issues than non-mechanized transportation. Reliable data is very hard to find (as e-bikes are new on the scene), but news reports indicate that older bikers are getting injured at higher rates than others. New York Governor Andrew Cuomo vetoed a bill that would’ve reauthorized electronic scooters and e-bikes on paths and bike lanes. He said that he believed the bill lacked important safety requirements, namely helmet use. However, Governor Phil Murphy of neighboring New Jersey eagerly signed a bill permitting scooters and e-bikes, hoping that “By bringing our motor vehicle laws into the 21st century, we will enable the rollout of e-bikes in Jersey City’s bike share program and expand the transportation options available to New Jerseyans.”

What can we expect for e-bikes in the near future? The annual e-bike market has surpassed $1.5 billion, with recognizable brands like BMW and Harley-Davidson jumping headfirst into this exciting commercial domain. We might soon see the statistic of the number of Americans who bike to work, currently about 1%, tick upwards. Minneapolis’ Nice Ride is leading the way for e-bikes in Minnesota, working with Lyft to bring 2,000 e-bikes to the city sometime in 2020. Minnesota law does not require either a license or a special motorized bicycle permit, but it does have other safety precautions like headlight use and an adult riding along if a minor is operating. So, if you’ve got the means, let it ride!

Will the Vaping Industry Go Up in Smoke?

October 2, 2019
Administrative Law, Food and Drug Law, Health Law

Stephen Wood, MJLST Staffer

It’s no secret that vaping has become increasingly popular. The number of users has increased from 7 million in 2011 to 41 million as of 2018. The total market is now worth an estimated $19.3 billion. Less clear is the future of industry regulation in light of the recent respiratory illnesses linked to vaping. On September 24, 2019, the Centers for Disease Control and Prevention reported that vaping was attributed to 805 illnesses and 12 deaths. Pressure is building on the industry’s major players. In the last week, we have seen the cancellation of a merger between two of the largest tobacco companies, Altria and Philip Morris, and the release of the CEO of Juul, Kevin Burns.

However, the respiratory illnesses associated with vaping haven’t been linked to a specific product, and it is unclear what the long-term effects of vaping are. Because of this uncertainty, some states have implemented blanket restrictions on the sale of vaping products, President Trump has proposed new regulations, and the CDC has issued warnings regarding their safety. This is blindsiding the industry, which has been free from regulation by the FDA until recently.

Vaping devices, also known as electronic nicotine delivery systems (ENDS), became subject to the FDA’s regulatory scheme for all tobacco products on August 8, 2016. The Deeming Rule placed ENDS in the same category of products as cigarettes and other traditional tobacco products, which have been regulated under the Family Smoking Prevention and Tobacco Control Act since 2009. For this reason, the minimum age for purchasing ENDS is 18 years old, and the marketing, manufacturing, and distribution of ENDS is heavily regulated.

Juul, in particular, has come under fire for its marketing strategies. Among other claims, many lawsuits allege that the company specifically targeted minors through its use of social media and distribution of enticing flavors. These practices have also been the focal point of the recent surge of state regulations, which “are filling what many see as a regulatory void caused by federal inaction.” For example, in Michigan, Governor Gretchen Whitmer implemented an emergency ban, limiting the sale of vaping products to those which are tobacco flavored. New York did the same but exempted menthol from the ban. Massachusetts, notably, implemented a four-month emergency ban on all products. President Trump’s proposed ban, on the other hand, would be limited to flavored products.

If President Trump’s proposal is adopted, the industry would see an estimated 80% loss in sales. It will be interesting to see what the regulatory landscape looks like once the smoke clears.

New Year, New Chinese Intellectual Property System

March 31, 2019
Administrative Law, Intellectual Property, Patents

Sherrie Holdman, MJLST Staffer

Since the beginning of the new year, China has implemented various new Intellectual Property (“IP”) changes. Three major changes are particularly critical for promoting an enhanced IP system in China.

The first change is the establishment of a new IP appellate court. On October 26, 2018, China’s National People’s Congress (NPC) Standing Committee issued the Decision on Several Issues Concerning the Litigation Procedures in Patent and Other Intellectual Property Cases. On December 3, 2018, in a plenary session of the Judicial Committee of the Supreme Court chaired by Chief Justice Zhou Qiang, the Committee passed the Supreme Court Guidance Re Intellectual Property Tribunal. The official IP court was finally launched in January 2019. The new body is expected to hear appeals from both civil and administrative matters. According to Chief Justice Zhou Qiang, handing civil and administrative patent appeals to the new IP court will help unify adjudications related to patent validity and infringement, improve the efficiency and quality of court proceedings, and thus improve judicial protection of IP rights. The protection of IP rights has been a key issue of the trade war between the United States and China. China has been criticized for its lax IP protection for many years. The new IP court seems to come as a trade negotiation of the two countries.

Another change is China’s new policy on IP enforcement. On December 4, 2018, the National Development and Reform Commission, along with 37 government departments, released a Chinese interagency Cooperation Memorandum of Understanding. The goal of the Memorandum was to punish entities who seriously violate the patent law, including acts such as repeated patent infringement, non-compliance with the patent law, and serious illegal patent agency conduct. Like the new IP court, this policy seems to be another negotiation between the United States and China. Indeed, the policy was released days after the meeting of United States President Donald Trump and Chinese leader Xi Jinping at a summit in Argentina. The policy took a further step to enhance the IP protection in China.

The third change is the Fourth Amendment of the Chinese Patent Law. On December 5, 2018, the latest Draft of the Chinese Patent Law was presented to China’s State Council in a meeting chaired by Premier Li Keqiang. The new Amendment aimed to strengthen the protection of patent rights holder’s legitimate rights and interests, stimulate innovations, and promulgate legislations to effectively protect patent rights. Specifically, the Draft aimed to increase the penalties for IP infringement, to increase the amount of compensation and fines for willful infringement and counterfeiting patents, and thus increase the infringement cost in order to deter illegal acts. Particularly, the Draft proposed to raise the minimum fine to 100,000 RMB and the maximum fine to 5 million RMB. The Draft also stated that an infringer shall be cooperative in an infringement lawsuit. The Draft further set forth that network service providers shall bear joint liability for not stopping infringement in a timely manner. The Draft provided an incentive mechanism for employee inventors so that they could equitably share profits from inventions invented by the employees in the course of their employment.. Further, the Draft introduced a patent term extension system for innovative drugs, strengthened public information systems, and proposed to make basic patent data available in the China National Intellectual Property Administration (“CNIPA”) website. In order to foster patent dissemination and utilization, the Draft provided national and local authorities to increase public patent services and introduced an open patent license system. In addition, the Draft introduced a domestic priority of six months for design applications, extended patent term for design patents to fifteen years, and extended the time period for priority document submission for patents/utility models applications. The Draft Amendments were released for public comment from January 4, 2019 to February 3, 2019. The final rule is expected to come out soon this year.

It remains to be seen how these changes would improve China’s IP system. Nevertheless, the impact of these changes should not be underestimated. China is known as a big market for technology and business. However, foreign investors have been hesitate to invest in China due to China’s lax patent protection. With these changes aiming to establish an enhanced IP system, China is expected to build a friendly commercial environment to foreign inventors and investors, continue to improve domestic innovations, and encourage collaborations between foreign corporations with local companies. For instance, it has been said that these changes would attract global pharmaceuticals and tech companies to China because an enhanced IP system would enable foreign companies to uphold their IP in specialist courts, which is a great reassurance for foreign investors and inventors.

Treating Depression With Ketamine? How the Investment Was Made

March 15, 2019
Administrative Law, Biotechnology, Food and Drug Law, Health Law

Hunter Moss, MJLST Staffer

Depression is a serious mental disorder that afflicts millions of Americans each year. One in three of these individuals struggles to find a treatment method that alleviates their condition, and are aptly said to suffer from treatment-resistant depression. In the most severe cases, treating depression can be a life or death decision—depression is the leading cause of over 41,000 suicides every year. For those dealing with depression, every day is a struggle to persevere and try to regain a sense of normalcy.

A new therapy for treatment-resistant depression was approved by the Food and Drug Administration (FDA) earlier this week, one that could help those that have been unable to find relief elsewhere. The unexpected source of the therapy is esketamine. If the name of this drug sounds familiar, it is because the name is based on, and molecularly similar to, the street drug named ketamine. While originally synthesized in the 1960’s as an anesthetic and first used widely in the Vietnam War, ketamine is now known as a party drug, providing the user with mild hallucinations and a sense of euphoria. Due to its dangerous side-effects and potential for abuse, ketamine was placed on the Schedule III of the United States Controlled Substance Act in August of 1999.

In the early 1990’s, researchers at Yale University first recognized the potential for ketamine to treat the symptoms of depression. Since then, scientists sought to confirm the viability of ketamine as a treatment option for individuals who did not experience relief from other treatment methods. A 2012 study out of Baylor College of Medicine proved just that: 85% of patients with severe depression reported the treatment to be effective. Unlike selective serotonin reuptake inhibitors (SSRIs), which are most commonly prescribed to treat depression and can take weeks to build in a patient’s system before becoming effective, ketamine can provide nearly immediate relief with its full effect being felt in as little as two days.

With the science firmly in place, the next hurdle advocates of ketamine faced was of perception—in the eyes of the FDA and the public alike. Radical clinics began to emerge across the country to provide patients suffering from treatment-resistant depression with a safe, heavily-monitored environment to undergo care. Because ketamine had yet to be recognized as a potential aid for depression by the FDA, clinic physicians would often have to prescribe the drug under the guise of using it as an anesthetic. The “don’t ask, don’t tell” approach to a new treatment for a severe mental disorder created some inevitable quandaries for both doctors and patients, who would be unable to receive insurance coverage for a non-FDA approved treatment program.

While the medical community was well aware of the healing potential of ketamine, pharmaceutical companies were reluctant to make the investment. The average price-tag of a clinical trial for the FDA is $19m. There is certainly a market for the drug with countless Americans suffering from depression. The issue holding pharmaceutical companies back is related to patent law. In order to receive a patent, the proposed invention must be novel—and considering that ketamine has been around for nearly sixty years, that would be an impossible claim to make. Without patent protection, the multi-million dollar investment is bad economics for big pharma, even if the trials could provide relief for millions of Americans.

So why did Janssen Pharmaceuticals, the developer of a treatment method for depression based on ketamine, make the investment and receive FDA approval for its new drug Sprovato? The answer is because Sprovato is esketamine, a sufficiently different molecule from ketamine to be patentable. Certain molecules can be left-handed and have right-handed doppelgangers. While it is beyond the scope of this blog piece (and the ability of its author) to explain the difference between the two, esketamine is the left-handed version of ketamine’s right hand. The deviation between the molecules is a significant enough difference to pass the novelty requirement necessitated by the U.S. Patent and Trademark Office (USPTO). While there is some debate as to whether esketamine is as effective as its counterpart, esketamine passed the FDA’s clinical trials and, for the most part, has been received as a viable alternative to ketamine treatment. This development could help legitimize the countless ketamine clinics that have emerged across the United States over the last few years, yielding a promising new alternative for those struggling with severe depression. At the same time, the story of ketamine raises questions about the roles of several actors in the health care system, specifically pharmaceutical companies, the FDA and the USPTO, in delaying the introduction of life saving medication in order to adhere their respective financial and regulatory requirements.

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