Administrative Law

Predicted Effects of Price Transparency on Healthcare Economics

March 29, 2022
Administrative Law, Health, Healthcare

David Edholm, MJLST Staffer

In 2019, the Centers for Medicare and Medicaid Services (CMS) promulgated the Price Transparency Rule in order to allow patients to access healthcare pricing information. The stated purpose of the Price Transparency Rule is as follows:

By disclosing hospital standard charges [including payer-specific negotiated charges and discounted-cash prices], we believe the public (including patients, employers, clinicians, and other third parties) will have the information necessary to make more informed decisions about their care. We believe the impact of these final policies will help to increase market competition, and ultimately drive down the cost of healthcare services, making them more affordable for all patients.

There is significant debate whether compliance with the Price Transparency Rule will actuate its intended purpose.

On the proponent side, economic theory to support this purpose statement comes from a market advocacy perspective. In order to drive down the cost of healthcare through competition, consumers must know the prices in advance in order to bargain between providers. By giving consumers the ability to shop around and barter, the thinking goes, providers will undercut competitors by lowering their own prices, even slightly below a competitor’s rate.

Another theory that supports price transparency is that shining light onto healthcare pricing will lead to more public outcry, guilting providers to lower overinflated or unconscionable gross charges or hospital fees. Public outcry may also compel states to create global healthcare budget caps, which have been shown to have positive price-lowering effects. A recent study from Rice University found that Maryland’s all-payer global budget policy reduces costs while increasing quality of care.

Skeptics of the rule, however, including the American Hospital Association (AHA), argue that price transparency will induce institutions that currently charge less than competitors to increase their prices to match their competitors, ultimately raising costs. In litigation, the DC Circuit responded to that argument, holding that, based on available research, this result is unlikely. Secretary Azar was not required to rely on definitive rather than predictive data in writing the requirements because of the novelty of the price disclosure scheme and the unique complexity of healthcare pricing. The DC Circuit held that relying on studies of similar price disclosure schemes in other industries was sufficient to inform a stable policy judgment.

However, the healthcare service market is of a unique nature in that quality of care may be a consumer’s primary consideration before seeking treatment, trumping price considerations. Alternatively, a consumer may assume that paying more means receiving higher-quality care. Quality of care is incredibly hard to measure and report, and unless a consumer has access to quality-of-care information alongside pricing information, they are more likely to make fallacious assumptions about this correlation. Another unique factor about healthcare shopping is that many consumers have a strong relationship with their physician, thus would base their decision primarily on receiving advice from one they trust, rather than the out-of-pocket cost of care, especially if the difference is negligible.

Last is the complexity of healthcare viewpoint. Opponents of the price transparency rule emphasize the nature of healthcare as an unpredictable trade. For example, if a patient consumer undergoes surgery to fix one problem, a surgeon may discover another problem amidst the procedure. The standard of care likely prompts the surgeon to correct both problems, thus the patient consumer will be charged an amount higher than they could have reasonably predicted. The AHA brought this argument to court to support its assertion that the price transparency rule violated the Administrative Procedure Act (APA) by overstating the rule’s benefits. The DC Circuit court responded that the rule did not require hospitals to publish every potential permutation of finalized charges, rather that the baseline charges are publicized. Thus, in the surgery scenario, a patient consumer should have access to the payer-negotiated rate to fix the initial problem.

The jury is out, so to speak, on the effects that Price Transparency Rule compliance will have on healthcare economics. But from a consumer perspective, rapidly increasing healthcare costs are at the forefront of relevant political issues.

Zombie Deer: Slowing the Spread of CWD

February 18, 2022
Administrative Law, Agriculture, Animal Law, Environment, Environmental Law, Public Lands

Warren Sexson, MJLST Staffer

Minnesota is one of the premier states in the Union for chasing whitetails. In 2020, over 470,000 licenses were purchased to harvest deer. As a hunter myself, I understand the importance of protecting Minnesota’s deer herd and habitat. The most concerning threat to whitetail deer in the state is Chronic Wasting Disease (CWD). CWD alters the central nervous system, similar to “mad cow disease,” causing deer to lose weight, stumble, drool, and behave similarly to an extra on The Walking Dead. It was first discovered in 1967 in Colorado mule deer and is transmissible to other ungulates such as moose, elk, red deer, black-tail deer, Sitka deer, and reindeer. It is 100% fatal in animals it infects and there is no known treatment or vaccine. While it currently poses no threat to humans, Canadian researchers have shown eating the meat from infected animals can infect hungry macaques, prompting the CDC and the World Health Organization to recommend against consumption of CWD positive animals. Luckily, in Minnesota there were only a handful of cases last season. Challenges still remain, however, and the Minnesota Department of Natural Resources (DNR) and the state legislature have tools at their disposal to combat the spread.

The DNR currently has a comprehensive response plan. In order to get a deer hunting license, the hunter has to pick what “zone” he or she will be hunting in. Minnesota is divided up into zones based off of the deer population and geography. Each zone has different guidelines for how many licenses will sell to the public. Some are “limited draw,” meaning a lottery system where only a certain number of applicants are selected, others are “over-the-counter,” meaning anyone who wants a license in that unit may buy one. Within the zoning system, the DNR has three “CWD Zone” classifications that restrict harvesting deer depending on the risks of the disease—surveillance, control, and management zones. Surveillance zones are where CWD has been found in captive deer or in wild deer in an adjacent zone. Control zones border the management zones, and management zones take up most of the south-eastern portion of the state, where CWD is highly concentrated. The restrictions in each type of zone vary, with surveillance zones being the least restricted and management zones being the most. Hunters have a key role in slowing the spread of CWD. Reducing deer populations in CWD ridden areas helps to reduce contact among deer and lower infection rates. However, there are other ways to further Minnesota’s commitment to slowing the spread of CWD.

The DNR can use emergency actions; it has done so recently. In October of 2021, the DNR temporarily banned moving farmed deer into and within the state through emergency action. Farmed deer (deer raised in captivity for use in trophy hunting) are a main vector of transmission for CWD. The ban was lifted in December but could have lasted longer. The DNR has emergency authority under Minn. Stat. § 84.027 Subd. 13(b) and (g). By enacting emergency declarations, the DNR can continue to use proven measures to slow the spread: requiring testing in high risk areas, banning movement between deer farms, increasing legal limits, and requiring hunters who desire a big buck to first harvest does in so called “Earn-a-Buck” programs. But, such emergency authority can only be 18 months at the longest. While limited in time, emergency orders provide the DNR the flexibility it needs to combat the disease’s spread.

The agency could also attempt to regulate by standard rulemaking authority as laid out in Chapter 14 of Minnesota’s statutes. The agency likely has authority to regulate deer hunting rules relating to CWD and recently has gained concurrent authority over deer farms along with the Board of Animal Health. However, if the DNR attempted to ban deer farming or imposed severe regulatory requirements, industry and interest groups would likely respond with legal challenges to the rulemaking process. In previous attempts to severely restrict deer farms, the Minnesota Deer Farmers Association has filed lawsuits attempting to block restrictions.

While the DNR likely can regulate deer hunting to slow the spread, the legislature is the best option for stopping deer farming as a whole. It is not necessarily a one-sided issue; a bi-partisan coalition of hunters and environmentalistswish to see the practice banned. State Rep. Rick Hansen (DFL) who chairs the House Environment and Natural Resources Finances and Policy Committee has discussed ending the practice and buying out all existing operators. Craig Engwall, head of the Minnesota Deer Hunters Association has additionally called for such a ban. State legislation would be the most comprehensive way to slow the spread of CWD.

State legislators should also consider funding more research for potential vaccines and treatments for CWD. Funding is beginning to pick up; Canadian researchers have begun working on potential vaccines. Additionally, Rep. Ron Kind’s (D-WI) bill, the Chronic Wasting Disease Research and Management Act passed the House of Representatives with Bipartisan support and awaits a vote in the Senate. While this is encouraging, more can be done to support scientific research and protect deer herds. If Minnesota wants to lead the United States in solving such a global issue, the bipartisan support exists to help tackle the largest threat to deer hunting in the U.S. and the state.

CWD threatens the state’s large and historic deer hunting tradition. The DNR and the state legislature have the tools at their disposal to impose meaningful reform to combat the spread of “zombie-deer,” so the population can thrive for generations to come.

The Mysterious Disappearance of Deference: What Is the Supreme Court’s Current Relationship to Federal Agencies?

February 7, 2022
Administrative Law, Bioethics, Copyrights, Regulatory, Uncategorized

Carly Michaud, MJLST Staffer

The Supreme Court has had no shortage of administrative law cases in the (possibly) final sessions of one of the Court’s administrative law scholars, Justice Stephen Breyer. Yet, Breyer has found himself and his ideological compatriots in the opposition on the topic in which he situates his expertise. In the recent case regarding OSHA’s ability to require COVID-19 vaccines, Breyer’s dissent repeated discusses the proper deference an agency’s determination should be given by the Supreme Court.

Notably absent from the case is any mention of the previous key to the relationship between the courts and federal agencies: Chevron deference. In fact, Chevron U.S.A., Inc. v. National Resources Defense Council, was, (as of a 2014 analysis in the Yale Journal on Regulation) the “Most Cited Supreme Court Administrative Law decision”. While previously considered a niche area, administrative law is now so ubiquitous in practice that as of July 2021, 55 law schools require students take a course in administrative law or one of its mainstays: legislation or statutory interpretation.

In spite of this, Chevron appears nowhere in the discussion of OSHA’s vaccine mandate, nor in the court’s earlier revocation of the CDC’s eviction moratorium. This absence suggests that perhaps this Court has become a body of health experts, relying on their own understanding of COVID-19 to determine whether these agency-created regulations are effective in their mission. Both cases center on whether an agency action to prevent the spread of COVID-19 is within the purview of their empowering statute, and, despite the broad statutory authorities of these agencies to protect the health of Americans, both actions were deemed beyond that authority.

But back to Chevron, has it been abandoned as a standard? Not yet, although there was some discussion of this proposition during the oral argument of American Hospital Association v. Becerra last November. The Court has not released an opinion yet on this case, however the Court of Appeals had previously upheld HHS’s ability to set reembursement rates, per its statutory authority.

In a final thrust of irony, the death knell for Chevron deference may come from a case challenging the very statute and the very agency whose decision-making was at issue in Chevron: the EPA and the Clean Air Act. This is particularly ironic as the EPA administrator whose decision-making was being challenged in Chevron was Anne Gorsuch, the mother of Supreme Court justice and noted antagonist of agency authority: Neil Gorsuch. Yes, in a tale mirroring Hamlet, Neil Gorsuch seems determined to destroy the administrative state that had entangled his mother in various administrative scandals. The latest edition of this showdown between the Gorsuchs and EPA is scheduled for Monday February 28, which will see the Supreme Court hearing arguments in West Virginia v. EPA and its consolidated cases.

This behavior by the Court belies a grave concern both about the continued disempowerment of federal agencies—which have been empowered directly by Congress—at the hands of the unelected judiciary. Further, the most cynical of us may see this as a direct assault on the authority of agencies that some justices may politically disagree with, further disregarding the knowledge of learned experts to push their own political agendas.

Holy Crap: The First Amendment, Septic Systems, and the Strict Scrutiny Standard in Land Use Law

December 22, 2021
Administrative Law, Constitutional Law, Discrimination, Environmental Law, First Amendment

Sarah Bauer, MJLST Staffer

In the Summer of 2021, the U.S. Supreme Court released a bevy of decisions favoring religious freedom. Among these was Mast v. City of Fillmore, a case about, well, septic systems and the First Amendment. But Mast is about so much more than that: it showcases the Court’s commitment to free exercise in a variety of contexts and Justice Gorsuch as a champion of Western sensibilities. It also demonstrates that moving forward, the government is going to need work harder to support that its compelling interest in land use regulation trumps an individual’s free exercise rights.

The Facts of Mast

To understand how septic systems and the First Amendment can even exist in the same sentence, it’s important to know the facts of Mast. In the state of Minnesota, the Pollution Control Agency (MPCA) is responsible for maintaining water quality. It promulgates regulations accordingly, then local governments adopt those regulations into ordinances. Among those are prescriptive regulations about wastewater treatment. At issue is one such ordinance adopted by Fillmore County, Minnesota, that requires most homes to have a modern septic system for the disposal of gray water.

The plaintiffs in the case are Swartzentruber Amish. They sought a religious exemption from the ordinance, saying that their religion forbade the use of that technology. The MPCA instead demanded the installation of the modern system under threat of criminal penalty, civil fines, and eviction from their farms. When the MPCA rejected a low-tech alternative offered by the plaintiffs, a mulch basin system not uncommon in other states, the Amish sought relief on grounds that the ordinance violated the Religious Land Use and Institutionalized Persons Act (RLUIPA). After losing the battle in state courts, the Mast plaintiffs took it to the Supreme Court, where the case was decided in their favor last summer.

The First Amendment and Strict Scrutiny

Mast’s issue is a land use remix of Fulton v. City of Philadelphia, another free exercise case from the same docket. Fulton, the more controversial and well-known of the two, involved the City of Philadelphia’s decision to discontinue contracts with Catholic Social Services (CSS) for placement of children in foster homes. The City said that CSS’s refusal to place children with same-sex couples violated a non-discrimination provision in both the contract and the non-discrimination requirements of the citywide Fair Practices Ordinance. The Supreme Court didn’t buy it, holding instead that the City’s policy impermissibly burdened CSS’s free exercise of religion.

The Fulton decision was important for refining the legal analysis and standards when a law burdens free exercise of religion. First, if a law incidentally burdens religion but is both 1) neutral and 2) generally applicable, then courts will not ordinarily apply a strict scrutiny standard on review. If one of those elements is not met, courts will apply strict scrutiny, and the government will need to show that the law 1) advances a compelling interest and 2) is narrowly tailored to achieve those interests. The trick to strict scrutiny is this: the government’s compelling interest in denying an exception needs to apply specifically to those requesting the religious exception. A law examined under strict scrutiny will not survive if the State only asserts that it has a compelling interest in enforcing its laws generally.

Strict Scrutiny, RLUIPA, and Mast

The Mast Plaintiffs sought relief under RLUIPA. RLUIPA isn’t just a contender for Congress’s “Most Difficult to Pronounce Acronym” Award. It’s a choice legal weapon for those claiming that a land use regulation restricts free exercise of religion. The strict scrutiny standard is built into RLUIPA, meaning that courts skip straight to the question of whether 1) the government had a compelling government interest, and 2) whether the rule was the least restrictive means of furthering that compelling government interest. And now, post-Fulton, that first inquiry involves looking at whether the government had a compelling interest in denying an exception specifically as it applies to plaintiffs.

So that is how we end up with septic systems and the First Amendment in the same case. The Amish sued under RLUIPA, the Court applied strict scrutiny, and the government failed to show that it had a compelling interest in denying the Amish an exception to the rule that they needed to install a septic system for their gray water. Particularly convincing at least from Coloradan Justice Gorsuch’s perspective, were the facts that 1) Minnesota law allowed exemptions to campers and outdoorsman, 2) other jurisdictions allowed for gray water disposal in the same alternative manner suggested by the plaintiffs, and 3) the government couldn’t show that the alternative method wouldn’t effectively filter the water.

So what does this ultimately mean for land use regulation? It means that in the niche area of RLUIPA litigation, religious groups have a stronger strict scrutiny standard to lean on, forcing governments to present more evidence justifying a refusal to extend religious exemptions. And government can’t bypass the standard by making regulations more “generally applicable,” for example by removing exemptions for campers. Strict scrutiny still applies under RLUIPA, and governments are stuck with it, resulting in a possible windfall of exceptions for the religious.

Employee Vaccine Mandates: So, Are We Doing This?

November 23, 2021
Administrative Law, Employment, Employment Law

Kristin Thompson, MJLST Staffer

Rewind to the beginning of September. President Biden had just announced a generalized plan for addressing the alarmingly slow rise in vaccination rates in the United States. His disposition was serious as he pleaded with the American public to go out and get vaccinated. During this address he laid out several different measures that, conceivably, would lead to a higher national vaccination rate. Included in this plan was a vaccine requirement for all federal employees and government contractors. This sanction did not come as much of a surprise, as federal employees had previously been asked to provide proof of vaccination to avoid stringent safety protocols in the workplace. What was surprising, however, was President Biden’s plea to the Department of Labor to develop a federal vaccine mandate or required weekly COVID testing for private companies employing more than one hundred employees.

In the wake of this announcement came many different responses. On the one hand there were some private U.S. companies already enforcing vaccine policies who seemed unrattled by a potential new federal mandate, and there were some companies who viewed it as a welcome opportunity to implement a vaccine policy by means of a third-party enforcer. On the other hand there were companies who loathe any type of government interference in their business activity and policy implementation, and those who have been specifically opposed to a vaccine requirement and may have even made promises to their employees saying as much. Those companies who opposed a vaccine mandate, in light of this plea from President Biden, had to start making strategic decisions on how they would move forward if the Department of Labor heeded the president’s request.

The questions that came following President Biden’s address were the same regardless of the company’s personal view. Would a federal mandate be legal, would it be constitutional, and would it ever come? This uncertainty hung in the air while private companies, those with 101 employees and 5,000 employees alike, began to prepare. Draft mandatory vaccine policies were made, legal counsel was requested, and employees were advised. Now all that was left to do was wait for the Department of Labor’s cue.

Fast-forward to November. The Department of Labor’s Occupational Safety and Health Administration (OSHA) released an emergency temporary standard (ETS) in line with President Biden’s plan. The goal of this standard being “to minimize the risk of COVID-19 transmission in the workplace,” and to “protect unvaccinated employees of large workplaces.” This standard mandates that all employers with more than 100 employees, including private companies, must require their employees get vaccinated or undergo weekly COVID tests and wear face masks while at work. The standard does not apply to remote workers, workers who predominantly work outside, or employees who work without other co-workers present.

The questions that arose after the ETS was announced were similar to those asked by companies directly after President Biden’s address. Is this ETS legal, is it constitutional, and when will we have to be in compliance? The last question seems to be easily answered; all requirements except weekly testing for unvaccinated employees must be met by December 6th, 2021. The weekly testing policy for unvaccinated employees must begin by January 6th, 2022. However, the immediate onslaught of lawsuits attempting to prevent the ETS have made these straightforward dates seem somewhat arbitrary. Companies now face a unique set of issues prompting even more, new, questions. Do we actually have to be in compliance by December 5th? What effect will these lawsuits have on the ETS? Are we just supposed to wait and see?

Legally, the situation private companies face is complex. As of November 12th, the Fifth Circuit had issued and subsequently reaffirmed a stay on the standard, meaning companies did not have to comply with the mandate. At that time, the Fifth Circuit was the only court that had issued a stay, although there were lawsuits pending in eleven of the twelve circuit courts. What complicated this Fifth Circuit determination was the question of whether or not it covered all U.S. companies; if your company is based in another Circuits’ jurisdiction was this Fifth Circuit stay relevant? The current ruling enjoins OSHA from enforcing the ETS, so while the Fifth Circuit did not write on whether their holding extended outside of their jurisdiction, its practical effect was, and is, felt everywhere. So then, what comes next? How long will this stay last, and who should private companies be looking to in planning their next move?

The Fifth Circuits’ stay will last until one of two things occur. The first is multidistrict litigation, where all outstanding lawsuits brought against the ETS will be combined, and one decision will be rendered by the Circuit Court on whether or not the stay shall be enforced. The first step of this process has already begun; on Tuesday November 16th the Sixth Circuit Court was chosen via a lottery process to preside over the multidistrict litigation. The Sixth Court is based in Cincinnati, Ohio and typically leans conservative. While this proclivity does not necessarily mean that the ETS is doomed, it does suggest that President Biden may ask the Supreme Court to take over the case, preferring the Supreme Court Justices over the Sixth Circuit’s judges. This introduces the second way the stay may be addressed, by a Supreme Court ruling. This alternative can be triggered by either a plea from the federal government directly asking the Court to end the Fifth Circuits’ stay, or via an independent decision by the Supreme Court to pluck this consolidated lawsuit out the Sixth Circuits’ hands.

However, if the Supreme Court is not called upon and chooses not to pull the case up on their own, the Sixth Circuit will have the authority to either end, modify, or extend the Fifth Circuits’ current stay on the ETS. This leaves companies with a choice; will they wait and see how the Sixth Circuit, or maybe even the Supreme Court, rules on the stay? Will they wait to see if the stay is extended and the deadline for compliance is pushed back, or will they start implanting the mandate now in the event that the stay is extinguished and December 5th compliance is reinstated?

There is a chance that an extended stay will allow these companies to push off vaccine mandates. There is also a chance that the stay will be terminated before December 5th and all original compliance deadlines will be the same. Both of these alternatives are further complicated when paired with the uncertainty surrounding timing. If a company decides to run the risk and hope for an extended stay, and the Sixth Circuit court issues a retraction of the stay on December 3rd, companies may still be forced to observe the December 5th compliance date. However, if they decide to comply right now and the stay is extended, they may regret acting so quickly. In the end the mass amount of uncertainty surrounding the ETS and resulting litigation is creating many tough decisions for private employers. While the choice to comply with OSHA’s currently suspended ETS may not be mandatory right now, it’s obvious that a failure to act may put them far behind schedule for creating and implanting an effective vaccine mandate policy. That failure to act has the potential to end in high OSHA fines as well as general pushback from the public. In the end the decision on how to treat this paused ETS is up to each individual company, as will be any consequences stemming from that choice.

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.

Watching an APA Case Gestate Live!

October 25, 2020
Administrative Law, Internet, Social Media

Parker von Sternberg, MJLST Staffer

On October 15th 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.

 

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.

Will the Vaping Industry Go Up in Smoke?

October 2, 2019
Administrative Law, FDA, Health, Uncategorized

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.

 

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