Health Law

Mental Health Telehealth Services May Not Be Protecting Your Data

March 5, 2023
Administrative Law, COVID-19, Data, Health Law, Healthcare, Internet, New Technology, Privacy

Tessa Wright, MJLST Staffer

The COVID-19 pandemic changed much about our daily lives, and nowhere have those changes been more visible than in the healthcare industry. During the pandemic, there were overflowing emergency rooms coupled with doctor shortages.[1] In-person medical appointments were canceled, and non-emergency patients had to wait months for appointments.[2] In response, the use of telehealth services began to increase rapidly.[3] In fact, one 2020 study found that telehealth visits accounted for less than 1% of health visits prior to the pandemic and increased to as much as 80% of visits when the pandemic was at its peak.[4] And, while the use of telehealth services has decreased slightly in recent years, it seems as though it is likely here to stay. Nowhere has the use of telehealth services been more prevalent than in mental health services.[5] Indeed, as of 2022, telehealth still represented over 36% of outpatient mental health visits.[6] Moreover, a recent study found that since 2020, over one in three mental health outpatient visits have been delivered by telehealth.[7] And while this increased use in telehealth services has helped make mental health services more affordable and accessible to many Americans, this shift in the way healthcare is provided also comes with new legal concerns that have yet to be fully addressed.

Privacy Concerns for Healthcare Providers

One of the largest concerns surrounding the increased use of telehealth in mental health services is privacy. There are several reasons for this. The primary concern has been due to the fact that telehealth takes place over the phone or via personal computers. When using personal devices, it is nearly impossible to ensure HIPAA compliance. However, the majority of healthcare providers now offer telehealth options that connect directly to their private healthcare systems, which allows for more secure data transmission.[8] While there are still concerns surrounding this issue, these secure servers have helped mitigate much of the concern.[9]

Privacy Concerns with Mental Health Apps

The other privacy concern surrounding the use of telehealth services for mental health is a little more difficult to address. This concern comes from the increased use of mental health apps. Mental health apps are mobile apps that allow users to access online talk therapy and psychiatric care.[10] With the increased use of telehealth for mental health services, there has also been an increase in the use of these mental health apps. Americans are used to their private medical information being protected by the Health Insurance Portability and Accountability Act (HIPAA).[11] HIPAA is a federal law that creates privacy rules for our medical records and other individually identifiable health information during the flow of certain health care transactions.[12] But HIPAA wasn’t designed to handle modern technology.[13] The majority of mental health apps are not covered by HIPAA rules, meaning that these tech companies can sell the private health data from their apps to third parties, with or without consent.[14] In fact, a recent study that analyzed 578 mental health-related apps found that nearly half (44%) of the apps shared users’ personal health information with third parties.[15] This personal health information can include psychiatric diagnoses and medication prescriptions, as well as other identifiers including age, gender, ethnicity, religion, credit score, etc.[16]

In fact, according to a 2022 study, a popular therapy app, BetterHelp, was among the worst offenders in terms of privacy.[17] “BetterHelp has been caught in various controversies, including a ‘bait and switch’ scam where it advertised therapists that weren’t actually on its service, poor quality of care (including trying to provide gay clients with conversion therapy), and paying YouTube influencers if their fans sign up for therapy through the app.”[18]

An example of information that does get shared is the intake questionnaire.[19] An intake questionnaire needs to be filled out on BetterHelp, or other therapy apps, in order for the customer to be matched with a provider.[20] The answers to these intake questionnaires were specifically found to have been shared by BetterHelp with an analytics company, along with the approximate location and device of the user.[21]

Another example of the type of data that is shared is metadata.[22] BetterHelp can share information about how long someone uses the app, how long the therapy sessions are, how long someone spends sending messages on the app, what times someone logs into the app, what times someone sends a message or speaks to their therapists, the approximate location of the user, how often someone opens the app, and so on.[23] According to the ACLU, data brokers, Facebook, and Google were found to be among the recipients of other information shared from BetterHelp.[24]

It is also important to note that deleting an account may not remove all of your personal information, and there is no way of knowing what data will remain.[25] It remains unclear how long sensitive information that has been collected and retained could be available for use by the app.

What Solutions Are There?

The U.S. Department of Health and Human Services recently released updated guidance on HIPAA, confirming that the HIPAA Privacy Rule does not apply to most health apps because they are not “covered entities” under the law.[26]  Additionally, the FDA put out guidance saying that it is going to use its enforcement discretion when dealing with mental health apps.[27] This means that if the privacy risk seems to be low, the FDA is not going to enforce or chase these companies.[28]

Ultimately, if mental telehealth services are here to stay, HIPAA will need to be expanded to cover the currently unregulated field of mental health apps. HIPAA and state laws would need to be specifically amended to include digital app-based platforms as covered entities.[29] These mental health apps are offering telehealth services, similar to any healthcare provider that is covered by HIPAA. Knowledge that personal data is being shared so freely by mental health apps often leads to distrust, and due to those privacy concerns, many users have lost confidence in them. In the long run, regulatory oversight would increase the pressure on these companies to show that their service can be trusted, potentially increasing their success by growing their trust with the public as well.

Notes

[1] Gary Drenik, The Future of Telehealth in a Post-Pandemic World, Forbes, (Jun. 2, 2022), https://www.forbes.com/sites/garydrenik/2022/06/02/the-future-of-telehealth-in-a-post-pandemic-world/?sh=2ce7200526e1.

[2] Id.

[3] Id.

[4] Madjid Karimi, et. al., National Survey Trends in Telehealth Use in 2021: Disparities in Utilization and Audio vs. Video Services, Office of Health Policy (Feb. 1, 2022).

[5] Shreya Tewari, How to Navigate Mental Health Apps that May Share Your Data, ACLU (Sep. 28, 2022).

[6] Justin Lo, et. al., Telehealth has Played an Outsized Role Meeting Mental Health Needs During the Covid-19 Pandemic, Kaiser Family Foundation, (Mar. 15, 2022), https://www.kff.org/coronavirus-covid-19/issue-brief/telehealth-has-played-an-outsized-role-meeting-mental-health-needs-during-the-covid-19-pandemic/.

[7] Id.

[8] Supra note 1.

[9] Id.

[10] Heather Landi, With Consumers’ Health and Privacy on the Line, do Mental Wellness Apps Need More Oversight?, Fierce Healthcare, (Apr. 21, 2021), https://www.fiercehealthcare.com/tech/consumers-health-and-privacy-line-does-digital-mental-health-market-need-more-oversight.

[11] Peter Simons, Your Mental Health Information is for Sale, Mad in America, (Feb. 20, 2023), https://www.madinamerica.com/2023/02/mental-health-information-for-sale/.

[12] Supra note 5.

[13] Supra note 11.

[14] Id.

[15] Deb Gordon, Using a Mental Health App? New Study Says Your Data May Be Shared, Forbes, (Dec. 29, 2022), https://www.forbes.com/sites/debgordon/2022/12/29/using-a-mental-health-app-new-study-says-your-data-may-be-shared/?sh=fe47a5fcad2b.

[16] Id.

[17] Supra note 11.

[18] Id.

[19] Supra note 5.

[20] Id.

[21] Id.

[22] Id.

[23] Id.

[24] Id.

[25] Supra note 5.

[26] Id.

[27] Supra note 10.

[28] Id.

[29] Supra note 11.

EJScreen: The Environmental Justice Tool That You Didn’t Know You Needed

March 4, 2023
Discrimination, Environmental Law, Industry, Public Health, Public Safety

Emma Ehrlich, Carlisle Ghirardini, MJLST Staffer

What is EJScreen?

EJScreen was developed by the Environmental Protection Agency (“EPA”) in 2010, 16 years after President Clinton’s Executive Order 12898 required federal agencies to begin keeping data regarding “environmental and human health risks borne by populations identified by race, national origin or income.” The program has been available to the public through the EPA’s website since 2015 and is a mapping tool that allows users to look at specific geographic locations and set overlays that show national percentiles for categories such as income, people of color, pollution, health disparities, etc. Though the EPA warns that EJScreen is simply a screening tool and has its limits, the EPA uses the program in “[i]nforming outreach and engagement practices, [i]mplementing aspects of …permitting, enforcement, [and] compliance, [d]eveloping retrospective reports of EPA work, [and] [e]nhancing geographically based initiatives.”

As the EPA warns on its website, EJScreen does not contain all pertinent information regarding environmental justice and other data should be collected when studying specific areas. However, EJScreen is still being improved and was updated to EJScreen 2.0 in 2022 to account for more data sets, including data on which areas lack access to food, broadband, and medical services, as well as health disparities such as asthma and life expectancy.

Current Uses

EJScreen software is now being used to evaluate the allocation of federal funding. In February of this year, the EPA announced that it will be allocating $1 billion of funding from President Biden’s Bipartisan Infrastructure Law to Superfund cleanup projects such as cleanups of sites containing retired mines, landfills, and processing and manufacturing plants. The EPA said that 60% of new projects are in locations that EJScreen indicated were subject to environmental justice concerns.

EJScreen is also used to evaluate permits. The EPA published its own guidance in August of 2022 to address environmental justice permitting procedures. The guidance encourages states and other recipients of financial assistance from the EPA to use EJScreen as a “starting point” when looking to see if a project whose permit is being considered may conflict with environmental justice goals. The EPA believes this will “make early discussions more meaningful and productive and add predictability and efficiency to the permitting process.” If an early EJScreen brings a project into question, the EPA instructs permitters to consider additional data before making a permitting decision.

Another use of EJScreen is in the review of Title VI Civil Rights Act Complaints. Using the authority provided by Title VI, the EPA has promulgated rules that prohibit any agency or group that is receiving federal funding from the EPA from functioning in a discriminatory way based on race, color, or national origin. The rules also enable people to submit Title VI complaints directly to the EPA when they believe a funding recipient is acting in a discriminatory manner. If it is warranted by the complaint, the EPA will conduct an investigation. Attorneys that have reviewed EPA response letters expressing its decision to conduct an investigation based on a complaint have noted that the EPA often cites EJScreen when explaining why they decided to move forward with an investigation.

In October of 2022, the EPA sent a “Letter of Concern” to the Louisiana Department of Environmental Quality (“LDEQ”) and the Louisiana Department of Health stating that an initial investigation suggests that the two departments have acted in ways that had “disparate adverse impacts on Black residents” when issuing air permits or informing the public of health risks. When discussing a nearby facility’s harmful health effects on residents, the EPA cites data from EJScreen in concluding that the facility is much more likely to have effects on black residents of Louisiana compared to non-black residents. The letter also touches on incorrect uses of EJScreen in saying that LDEQ’s conclusion that a proposed facility would not affect surrounding communities was misleading because the LDEQ used EJScreen to show that there were no residents within a mile of the proposed facility but ignored a school located only 1.02 miles away from the proposed location.

Firms such as Beveridge & Diamond have recognized the usefulness of this technology. They urge industry decision makers to use this free tool, and others similar to it, to preemptively consider environmental justice issues that their permits and projects may face when being reviewed by the EPA or local agencies.

Conclusion

In conclusion, EJScreen has the potential to be a useful tool, especially as the EPA continues to update it with data for additional demographics. However, users of the software should heed EPA’s warning that this is simply a screening tool. It is likely best used to rule out locations for certain projects, rather than be solely relied on for approving projects in certain locations, which requires more recent data to be collected.

Lastly, EJScreen is just one of many environmental justice screening tools being used and developed. Multiple states have been developing their own screening programs, and there is research showing that using state screening software may be more beneficial than national software. An environmental justice screening tool was also developed by the White House Council on Environmental Quality in 2022. Its Climate and Economic Justice Screening Tool is meant to assist the government in assigning federal funding to disadvantaged communities. The consensus seems to be that all available screening tools are helpful in at least some way and should be consulted by funding recipients and permit applicants in the early rounds of their decision making processes.

Hazardous Train Derailment: How a Poor Track Record for Private Railway Company May Impact Negligence Lawsuit Surrounding Major Incident

March 4, 2023
Environmental Law, Litigation, Public Health, Public Safety, Torts Law, Transportation

Annelise Couderc, MJLST Staffer

The Incident

On Friday, February 3rd a train with about 150 cars, many carting hazardous chemicals, derailed in East Palestine, Ohio. The derailment resulted in the leakage and combustion of an estimated 50 train cars containing chemicals hazardous to both humans and the environment. The mayor of East Palestine, Ohio initially evacuated the city, and neighboring towns were told to stay indoors with residents being told they could return five days following the explosion. According to a member of the National Transportation Safety Board, 14 cars containing multiple hazardous chemicals including vinyl chloride, a chemical in plastic products which is associated with increased risk of liver cancer and cancer generally, were “exposed to fire,” combusted into the air which could then be inhaled by residents or leach into the environment. There have been reports by residents of foul smells and headaches since the incident, and locals have reported seeing dead fish in waterways.

The train and railroad in question are owned and operated by Norfolk Southern, a private railway company. Norfolk Southern transports a variety of materials, but is known for its transportation of coal through the East and Midwest regions of the country. In order to prevent a large explosion with the chemicals remaining in the train cars, Norfolk Southern conducted a “controlled release” of the chemicals discharging “potentially deadly fumes into the air” on Monday, February 6th. While the controlled release was likely immediately necessary for safety purposes, exposure to vinyl chloride as a gas can be very dangerous, leading to headaches, nausea, liver cancer, and birth defects.

Government and Norfolk Southern Responds

Following the derailment and fires, a variety of governmental authorities have converged to tackle the issue, in addition to Norfolk Southern. The Environmental Protection Agency (EPA) and Norfolk Southern are monitoring air-quality, and giving guidance to determine when investigators and fire fighters may enter the scene safely. In a joint statement on February 8th, the Governors of Ohio and Pennsylvania, as well as East Palestine’s Fire Chief, announced that evacuated residents could return to their homes. As an act of good faith Norfolk Southern enlisted an independent contractor to work with local and federal officials to test air and water quality, and pledged $25,000 to the American Red Cross and its shelters to help residents. The Ohio National Guard has also been brought onto the scene.

As more information is released, things are heating up in the press as reporters try to learn more about what happened. In a press conference on February 8th with Ohio’s governor, Mike DeWine, the commander of the Ohio National Guard pushed a cable news reporter who refused to stop his live broadcast after asked by authorities and was subsequently arrested and held in jail for five hours. DeWine denies authorizing the arrest, and a Pentagon official has come out condemning the behavior as unacceptable. The Ohio attorney general will lead an investigation into the arrest.

Lawsuit Filed Alleges Negligence

Norfolk Southern’s history regarding brake safety as well as general operational changes in the railroad sector will perhaps play a factor in the lawsuit recently filed in response to the incident. In East Palestine, Ohio, residents and a local business owner are alleging negligence in a lawsuit against Norfolk Southern in federal court. Union organizers have expressed concerns that operating changes and cost-cutting measures like the elimination of 1/3 of workers in the last six years have resulted in less thorough inspection and less preventative maintenance. Although railroads are considered the safest form of transporting hazardous chemicals, Federal Railroad Administration (FRA) data shows that hazardous chemicals were released in 11 accidents in 2022, and 20 in both 2020 and 2018. Recently, there has been an uptick in derailments, and although most occur in remote locations, train car derailments have in fact killed people in the past.

The class-action lawsuit alleges negligence against Norfolk Southern for “failing to maintain and inspect its tracks; failing to maintain and inspect its rail cars; failing to provide appropriate instruction and training to its employees; failing to provide sufficient employees to safely and reasonably operate its trains; and failing to reasonably warn the general public.” The plaintiffs allege the company should have known of the dangers posed, and therefore breached their duty to the public.

Specifically relevant to this accident may be Norfolk Southern’s lobbying efforts against the mandatory use of Electronically Controlled Pneumatic (ECP) brakes. In 2014, likely in response to increased incidents, the Obama administration “proposed improving safety regulations for trains carrying petroleum and other hazardous materials,” which included brake improvement. The 2015 Fixing America’s Surface Transportation (FAST) Act required the Department of Transportation (DOT) to test ECP braking, and the Government Accountability Office to calculate the costs and benefits of ECP braking.[1] The U.S. Government Accountability Office (GAO) conducted a cost benefit test on the ECP braking, and found the costs outweighed the benefits.[2] The FRA, the Pipeline and Hazardous Materials Safety Administration (PHMSA), and DOT subsequently abandoned the ECP brake provision of the regulation in 2017. The move followed a change in administration and over $6 million in lobbying money towards GOP politicians and the Trump administration by the American Association of Railroads, a lobbying group of which Norfolk Southern is a dues-paying member.

Despite bragging about their use of ECP brakes in 2007 in their quarterly report, Norfolk Southern’s lobbying group opposed mandatory ECP brakes, stating “In particular, the proposals for significantly more stringent speed limits than in place today and electronically controlled pneumatic (ECP) brakes could dramatically affect the fluidity of the railroad network and impose tremendous costs without providing offsetting safety benefits.” Although the type of brakes on the train in East Palestine is unknown as of now, a former FRA senior official told a news organization that ECP brakes would have reduced the severity of the accident. Whether or not using ECP braking while hauling hazardous materials constitutes negligence, despite the federal government finding they are not beneficial enough to make it mandatory, the fact that Norfolk Southern opposed its implementation may still influence the litigation.

Although the current lawsuit filed alleges negligence against Norfolk Southern, the private company, it is perhaps possible to approach the legal debate from an agency perspective. Did the PMHSA and FRA permissibly interpret FAST in failing to include ECP braking requirements when they were explicitly mentioned in the FAST text? Did the agencies come to an acceptable conclusion about ECP braking based on the data? If a court were to find the agencies’ decisions were outside of the scope of the authority granted to them by FAST, or that the decision was arbitrary and capricious, the agencies could be forced to reevaluate the regulation regarding ECP braking. Congress could also pass more specific legislation in response, to increase safety measures to prevent something like this from happening again.

The events are still unfolding from the train derailment in Ohio, and there are still many unknown variables. It will be interesting to see how the facts unfold, and how/if residents are about to recoup their losses and recover from the emotional distress this event undoubtedly caused.

Notes

[1] Regulations.gov, regulations.gov (search in search bar for “phmsa-2017-0102”; then choose “Electronically Controlled Pneumatic Braking- Updated Regulatory Impact Analysis”; then click “download.”)

[2] Regulations.gov, regulations.gov (search in search bar for “phmsa-2017-0102”; then choose “Technical Corrections to the Electronically Controlled Pneumatic Braking Final Updated RIA December 2017”; then click “download.”)

The Apathetic Divide: Surrogacy and the Anglo-American Courtroom

February 20, 2023
Ethics, EU Law, Health Law, Healthcare, Reproductive Health

Kelso Horne, MJLST Staffer

The State of New York defines Gestational Surrogacy as “a process where one person, who did not provide the egg used in conception, carries a fetus through pregnancy and gives birth to a baby for another person or couple.” The process of surrogacy can be fraught with legal, technical, and moral issues, particularly when the surrogacy is paid for via contract with the surrogate, also called Compensated Gestational Surrogacy (CGS). Until 2020, this kind of contractual paid surrogacy was illegal in the state of New York. That year, it was legalized, and the regulatory regime normalized by the Child-Parent Security Act.  In contrast, the state of Louisiana has one of the harshest gestational surrogacy regimes in the world, outright banning CGS, and requiring both sets of gametes to come from a couple married residing in the state of Louisiana. But these competing regulatory regimes are not replicated across the nation. To the contrary, most states have not passed any laws legalizing or banning CGS or other fertility practices, like the sale of gametes. With sparse case law and frequent legal limbo, the question of “is CGS legal for me?” can be a difficult question for many Americans.

Across the Atlantic, the question used to be an easy one to answer. In 1985 the UK Parliament Enacted the Surrogacy Arrangements Act, which made it an offense to “initiate or take part in any negotiations with the view of making a surrogacy arrangement”, along with some related activities, like compiling information to assist in the creation of surrogacy arrangements. Critically, however, the Act did not criminalize the act of looking to hire a surrogate, or looking to become one, only being a middleman, or publishing advertisements on behalf of those looking to obtain the services of a surrogate. The Human Fertilisation and Embryology Act 1990 defined the mother of a child under UK law as “[t]he woman who is carrying or has carried a child… and no other woman”. In 2001, the Lords Appeal in Ordinary, which acted as the UK’s highest court until 2009, heard the appeal in Briody v. St Helens and Knowsley Area Health Authority. The question before the Lords was one of damages. A woman, rendered infertile as a result of medical negligence, sought £78,267 in order to obtain the services of a surrogate in California, which had legalized CGS in 1993 in the landmark case Johnson v. Calvert. The Lady Justice Hale, speaking for the court, foreclosed the use of CGS in California or elsewhere, as the proposal was “contrary to the public policy of the country”. While she did not entirely dismiss the idea of providing damages to pay for surrogacy procedures, she said it would be permitted only in the case of a voluntary, unpaid surrogate.

Few appellate court judges get to issue an opinion on the same facts twice in their career. In 2020, in one of her final cases prior to retiring, the Lady Justice Hale, now sitting on the UK Supreme Court, which by then had replaced the Lords Appeal in Ordinary, did just that.  In Whittington Hospital NHS Trust (Appellant) v XX, the court determined that a woman who had been rendered infertile as a result of medical negligence could claim damages, including the costs to pay a United States based surrogate to carry her children. CGS, while still entirely illegal in the UK, could now nevertheless provide the basis for damages in a UK court. The Court did note some factual differences between Whittington Hospital and Briody, notably, that the likelihood that a surrogacy arrangement would result in a child was higher in the former. However, the court’s main argument for its opposite ruling was a change in cultural attitude to surrogacy and its role in society, stating “[t]he use of assisted reproduction techniques is now widespread and socially acceptable.”

While admitting that surrogacy was now widely accepted in UK society, the dissent, authored by The Lord Justice Carnwath, nevertheless disagreed with the Court. It argued that the criminal law of the UK remained clearly averse to commercial surrogacy, and that by awarding damages for CGS in California the court misaligned the UK’s civil and criminal law. Thus, the CGS regimes of the UK and the U.S. are now bound together. UK citizens may seek surrogacy arrangements and have them compensated by the UK government through the UK’s National Health Service, but they must use an American “womb”. A financial arrangement which the UK itself deems too unethical to allow inside its own borders is nevertheless legalized and compensated when occurring in other countries. The deeply strange situation is mirrored in the opaque CGS law in the United States itself.

A quick glance at any 50-state review of laws, compiled either by supporters or opponents to commercial surrogacy, paint a similar picture. They show strange ad hoc mixes of case law which often cover ancillary issues or are at least 30 years old. Some scholars have started to publicly discuss the possible ethical pitfalls of “procreative tourism”, but without clear legal rules governing what arrangements are and are not allowed, it becomes difficult to discuss possible solutions. The dangers of this shadow regime were thrown into stark relief by the war in Ukraine, which prior to the Russian invasion was a major source of surrogate mothers. Mothers were paid on average $15,000 per child, which is considerable in a country where, prior to the invasion, the GDP per capita was less than $5,000. The United States needs to determine if it wishes to become a “destination” country for procreative tourism, as the result in Whittington would seem to suggest it is, and whether it wishes to allow its own citizens the opportunity to travel abroad to engage in CGS.

This blog has touched on only a small fraction of the issues which are faced when determining the ideal regulatory regime for surrogacy. However, a lack of discussion, and a failure to acknowledge possible risks leaves us ignorant of what the problems may be, let alone the route to potential solutions. States have largely failed to address the issue since the first CGS baby was born in their borders, usually in the late 1980’s and early 1990’s. It’s time for a serious examination of CGS regulation as it exists, as well as a meaningful discussion about safeguarding the health and wellbeing of those involved in such a transaction. The UK has now done the same, passing the buck without a serious response to the issues surrounding CGS. Regardless of one’s opinion on the results of the Louisiana and New York regulations, potential participants in a surrogacy arraignment in those two states know the boundaries. That should be the case nationwide.

Behind the “Package Insert”: Loophole in FDA’s Regulation of Off-Label Prescriptions

November 12, 2022
Administrative Law, Food and Drug Law, Health Law, Healthcare, Industry, Public Health

Yolanda Li, MJLST Staffer

FDA Regulation of Drug Prescription Labeling and the “Package Insert”

Over the recent years, constant efforts have been made towards regulating medical prescriptions in an attempt to reduce risks accompanied with drug prescriptions. Among those efforts is the FDA’s revision of the format of prescription drug information, commonly known as the “package insert”.[1]

The package insert regulation, effective since 2006, applies to all prescription drugs. The package insert is to provide up-to-date information on the drug in an easy-to-read format. One significant feature is a section named “highlights”, which provides the most important information regarding the benefits and risks of a prescribed medication. The highlights section is typically half a page in length providing a concise summary of information including “boxed warning”, “indications and usage”, and “dosage and administration”.[2] The highlights section also refers physicians to appropriate sections of the full prescribing information. In this way, the package insert aims to draw both the physicians’ and the patients’ attention to the prescription of a drug, consequently accomplishing the ultimate purpose of managing medication use and reducing medical errors. Mike Leavitt, the Health and Human Services Secretary of the FDA commented that the package insert “help[s] ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare.”[3]

FDA Regulation of Off-Label Prescription and the Emergence of a Loophole

The FDA’s regulations relating to the labeling of prescription drugs, although systematic in its form, are cut short to a certain extent due to its lack of regulation on off-label prescriptions. Off-label prescriptions do not refer to a physician prescribing non-FDA approved drugs, a common misunderstanding by the public. Rather, off-label prescriptions are those that do not conform to the FDA-approved use set out in the FDA-approved label.[4] More specifically, off-label prescription generally refers to: “(1) the practice of a physician prescribing a legally manufactured drug for purposes other than those indicated on that drug’s FDA mandated labeling; (2) using a different method of applying the treatment and prescribing a drug, device, or biologic to patient groups other than those approved by FDA; and (3) prescriptions for drug dosages that are different from the approved label-recommended dosage or for time periods exceeding the label-recommended usage.”[5] For example if Drug A’s use, as mandated by the FDA, is to treat chronic headaches, and a physician prescribes it to treat a patient’s sprained ankle, that is an off-label prescription. However, such practice is common as estimated by the American Medical Association (AMA).[6]

The commonly approach is that the FDA and courts do not to interfere with physicians’ off-label uses.[7] Thus, when the FDA regulates the labeling of approved uses but does not regulate prescriptions for off-label uses, a loophole is formed. Andrew von Eschenbach, M.D., claims that because the FDA’s package insert regulation makes it easier for physicians to get access to important information about drugs, including drug safety and benefits, this regulation helps physicians to have more meaningful discussions with patients.[8] However, physicians’ discretion in prescribing off-label prescriptions would offset the proposed benefit of the FDA regulation because the regulation remains as guidance without force of law once physicians choose to go off from FDA’s approved uses of drugs. The easy-to-understand feature of the package insert and its benefit for a patient’s understanding of the drug becomes futile when physicians exercise discretion and prescribe drugs for uses not written on the inserts. In sum, when a patient receives an off-label prescription, the insert provides them little benefit as it addresses benefits and risks related to a different use of the drug.

It is undisputed that drug manufacturers have less discretion regarding drug labeling than physicians. If a manufacturer included an off-label use on a drug’s label, and promoted the off-label use of the drug, the drug would be considered misbranded. The manufacturer would then be subject to liability[9] as manufacturing a misbranded product in interstate commerce is prohibited.[10] However, the effect of regulations on manufacturers still fail to eliminate the loophole in off-label prescription: in response to the regulations, the manufacturer usually receives FDA approval for only a few drug uses and then relies on physicians prescribing off-label uses to ensure their profitability.[11] In this way, the manufacturer avoids liability under regulation and furthers the loophole in off-label prescription by encouraging physicians to prescribe more off-label uses in order to expand the manufacturer’s market.[12]

Why are Off-Label Prescriptions Difficult to Regulate?

One of the main reasons behind the lack of regulation of off-label prescriptions is the FDA’s objective in ensuring effective delivery of health care. Physicians are encouraged to use discretion and judgment in order to tailor prescription to patients’ individual conditions.[13] Another reason is to increase efficiency in treatments by avoiding the lengthy FDA approval process.[14] Aspirin was widely prescribed to reduce the risk of heart attack long before it was FDA-approved for this purpose; off-label prescriptions have also been proven effective in treatment of cancer, and off-label therapies have prolonged the lives of AIDS patients.[15] Another concern is drug prices in the United States, and promoting off-label uses has been found to help reduce drug prices as increased sales volume enables drug companies to lower their prices.[16] Indeed, off-label prescription has become a mainstream of medicine: “the FDA has long tolerated off-label drug use and has disclaimed any interest in regulating physicians’ prescribing practices.”[17] Today it is unclear whether the agency even has jurisdiction to regulate off-label prescription of drugs.[18]

In sum, there is clear guidance on the labeling of prescription drugs as a result of FDA regulation. However, because of difficulties in enforcement, the custom and widely accepted practice of off-label prescriptions and the inherent benefit of off-label prescription, the effects of the regulation are not as effective as what was firstly planned and proposed.

Notes

[1] The FDA Announces New Prescription Drug Information Format, U.S. Food & Drug Adm’ (Dec. 04 2015) https://www.fda.gov/drugs/laws-acts-and-rules/fda-announces-new-prescription-drug-information-format.

[2] Id.

[3] Id.

[4] Margaret Z. Johns, Informed Consent: Requiring Doctors to Disclose Off-Label Prescriptions and Conflicts of Interest, 58 Hastings L.J. 967, 968 https://plus.lexis.com/document?crid=35364c11-2939-4e58-bceb-dab7ae8f0154&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A4P0W-GY20-00CW-906B-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=7341&pdmfid=1530671&pdisurlapi=true.

[5] Lisa E. Smilan, The off-label loophole in the psychopharmacologic setting: prescription of antipsychotic drugs in the nonpsychotic patient population, 30 Health Matrix 233, 240 (2020), https://plus.lexis.com/document/?pdmfid=1530671&crid=367cf8ad-295e-4f14-97fa-737618718d61&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A64BT-RR31-JWBS-61KV-00000-00&pdworkfolderid=5506aeec-9540-4837-89f0-5a1acfd81d8b&pdopendocfromfolder=true&prid=1d42abd0-b66e-43af-a61a-0d1fb94180f5&ecomp=gdgg&earg=5506aeec-9540-4837-89f0-5a1acfd81d8b#.

[6] Supra note 4.

[7] Sigma-Tau Pharms. v. Schwetz, 288 F.3d 141, 148, https://plus.lexis.com/document?crid=7d2a2b00-13ad-4953-968e-82a28724aa00&pddocfullpath=%2Fshared%2Fdocument%2Fcases%2Furn%3AcontentItem%3A45RF-5H50-0038-X1PB-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=6388&pdmfid=1530671&pdisurlapi=true.

[8] Supra note 1.

[9] 21 CFR 201.5, https://plus.lexis.com/document/?pdmfid=1530671&crid=e02a99fb-be65-4525-b83c-a167f3e21b93&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A603K-BXD1-DYB7-W30Y-00000-00&pdcontentcomponentid=5154&pdworkfolderlocatorid=NOT_SAVED_IN_WORKFOLDER&prid=ff2b7e20-9dab-49b0-8385-627c16ee0ba2&ecomp=vfbtk&earg=sr2.

[10] 21 CFR 801.4, https://plus.lexis.com/document/?pdmfid=1530671&crid=721a586d-52a4-4228-b0c3-c464a77d6e6a&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A638R-X4S3-GXJ9-32FV-00000-00&pdcontentcomponentid=5154&pdworkfolderlocatorid=NOT_SAVED_IN_WORKFOLDER&prid=ff2b7e20-9dab-49b0-8385-627c16ee0ba2&ecomp=vfbtk&earg=sr6.

[11]  Supra note 4.

[12] Id.

[13]   Supra note 7.

[14]   Supra note 4.

[15]  Id.

[16] Supra note 4, at 981.

[17] ​​Kaspar J. Stoffelmayr, Products Liability And “Off-label” Uses Of Prescription Drugs, 63 U. Chi. L. Rev. 275, 279, https://plus.lexis.com/document?crid=a2181ffc-7f3e-4bce-b82e-08ba9111194f&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A3S3V-4CF0-00CV-K03W-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=7358&pdmfid=1530671&pdisurlapi=true.

[18]  Id.

Beef (and Residual Hormones?). It’s What’s for Dinner.

November 6, 2022
Administrative Law, Agriculture, Environmental Law, Food and Drug Law, Health Law, Industry, Public Safety

Kira Le, MJLST Staffer

The beef industry in the United States has been using hormones, both natural and synthetic, to increase the size of cattle prior to slaughter for more than a century.[1] Capsules are implanted under the skin behind a cow’s ear and release specific doses of hormones over a period of time with the goal of increasing the animal’s size more quickly. Because the use of these hormones in the beef industry involves both drug regulation and food safety regulations, both the U.S. Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) are responsible for ensuring the safety of the practice and regulating its use.[2] According to the FDA, “scientific data” is used to establish “acceptable” safe limits for hormones in meat by the time it is consumed.[3] Agricultural science experts support the fact that the naturally-occurring hormones used in beef production, such as estrogen, are used in amounts much smaller than those that can be found in other common foods, such as eggs and tofu.[4] However, the debate within the scientific community, and between jurisdictions that allow the sale of hormone-treated beef (such as the United States) and those that have banned its importation (such as the European Union), is still raging on in 2022 and has led to significant distrust in the beef industry by consumers.[5] With the release of research earlier this year presenting opposing conclusions regarding the safety of the use of synthetic hormones in the beef industry, the FDA has a responsibility to acknowledge evidence suggesting that such practices may be harmful to human health.

Some defend the use of hormones in the beef industry as perfectly safe and, at this point, necessary to sustainably feed a planet on which the demand for meat continues to increase with a growing population. Others, such as the European Union and China, both of which have restricted the importation of beef from cattle implanted with growth-promoting hormones, argue that the practice threatens human health.[6] For example, a report out of Food Research Collaboration found that a routinely-used hormone in United States beef production posed a significant risk of cancer.[7] Such a finding is reminiscent of when, in the not-too-distant past, known carcinogen diethylstilbestrol (DES) was used in U.S. cattle production and led to dangerous meat being stocked on grocery store shelves.[8]

This year, research published in the Journal of Applied Animal Research discussed the effects that residual hormones left in beef and the environment have on human health in the United States.[9] Approximately 63% of beef cattle in the United States are implanted with hormones, most of which are synthetic.[10] Despite organizations and agencies such as the FDA assuring consumers that the use of these synthetic hormones in cattle production is safe, the residues that can be left behind may be carcinogenic and/or lead to reproductive or developmental issues in humans.[11] Furthermore, the National Residue Program (NRP), housed in the USDA, is not only the “only federal effort that routinely examines food animal products for drug residues,” but also only examines tissues not commonly consumed, such as the liver and kidney.[12] Researchers Quaid and Abdoun offer the example of Zeranol, a genotoxic synthetic hormone used in beef production in the United States that activates estrogen receptors, causing dependent cell proliferation in the mammary glands that may result in breast cancer.[13] They also noted the problem of residual hormones found in the environment surrounding cattle production locations, which have been found to reduce human male reproductive health and increase the risk of some endocrine cancers.[14]

Also this year, researchers published an article in the Journal of Animal Science claiming that despite the “growing concern” of the effects of residual hormones on human health, including the earlier onset of puberty in girls and an increase in estrogen-related diseases attributed to the excessive consumption of beef, research shows that cattle treated with hormones, “when given at proper administration levels, do not lead to toxic or harmful levels of hormonal residues in their tissues.”[15] The researchers concluded that the hormones have no effect on human health and are not the cause of disease.[16]

Perhaps it is time for the FDA to acknowledge and address the scientific disagreements on the safety of the use of hormones – synthetic hormones, especially – in beef production, as well as reassure consumers that players in the agriculture industry are abiding by safety regulations. Better yet, considering the currentness of the research, the inconsistency of the conclusions, and the seriousness of the issue, formal hearings – held by either the FDA or Congress – may be necessary to rebuild the trust of consumers in the U.S. beef industry.

Notes

[1] Synthetic Hormone Use in Beef and the U.S. Regulatory Dilemma, DES Daughter (Nov. 20, 2016), https://diethylstilbestrol.co.uk/synthetic-hormone-use-in-beef-and-the-us-regulatory-dilemma/.

[2] Id.

[3] Steroid Hormone Implants Used for Growth in Food-Producing Animals, U.S. Food and Drug Admin (Apr. 13, 2022), https://www.fda.gov/animal-veterinary/product-safety-information/steroid-hormone-implants-used-growth-food-producing-animals.

[4] Amanda Blair, Hormones in Beef: Myths vs. Facts, S.D. State Univ. Extension (July 13, 2022), https://extension.sdstate.edu/hormones-beef-myths-vs-facts.

[5] See Julia Calderone, Here’s Why Farmers Inject Hormones Into Beef But Never Into Poultry, Insider (Mar. 31, 2016), https://www.businessinsider.com/no-hormones-chicken-poultry-usda-fda-2016-3 (discussing the debate within the scientific community over whether the use of hormones in animals raised for human consumption is a risk to human health).

[6] New Generation of Livestock Drugs Linked to Cancer, Rafter W. Ranch (June 8, 2022), https://rafterwranch.net/livestock-drugs-linked-to-cancer/.

[7] Id.

[8] Synthetic Hormone Use in Beef and the U.S. Regulatory Dilemma, DES Daughter (Nov. 20, 2016), https://diethylstilbestrol.co.uk/synthetic-hormone-use-in-beef-and-the-us-regulatory-dilemma/.

[9] Mohammed M. Quaid & Khalid A. Abdoun, Safety and Concerns of Hormonal Application in Farm Animal Production: A Review, 50 J. of Applied Animal Rsch. 426 (2022).

[10] Id. at 428.

[11] Id. at 429–30.

[12] Id. at 430.

[13] Id. at 432–33.

[14] Id. at 435.

[15] Holly C. Evans et al., Harnessing the Value of Reproductive Hormones in Cattle Production with Considerations to Animal Welfare and Human Health, 100 J. of Animal Sci. 1, 9 (2022).

[16] Id.

Whisky Is for Drinking, Water Is for Fighting

October 25, 2022
Administrative Law, Climate Change, Environmental Law, Public Health

Poojan Thakrar, MJLST Staffer

The American Southwest often lives in our imagination as an arid environment with tumbleweeds strewn about. This hasn’t been truer in centuries, as the Colorado River is facing its worst drought in 1200 years, in large part because of climate change.[1] The Colorado River is the region’s most important river, providing drinking water to about 40 million people.[2] In June, the federal government gave the seven states[3] that rely on the water two months to draft a water conservation agreement or risk federal intervention. The states blew past that deadline and the DOI’s Bureau of Reclamation imposed cuts to water usage as high as 21%.[4]

The History of the Modern Colorado River Allocation System

In 1922, the Colorado River Compact allocated an annual amount of 15 million acre-feet (maf) evenly between the Upper and Lower Basin states.[5] One acre-foot represents the volume of water that covers one acre in one foot of water and is about the amount of water that a family of four uses annually.[6] However, relying on 15 maf was already problematic; data from the past three centuries showed that the Colorado River has average flows of 13.5 maf, with some years as low as 4.4 maf.[7] 

Moreover, Arizona refused to sign this compact, arguing that water should be allocated amongst individual states instead of between river basins.[8] Tensions flared in 1935 as Arizona moved National Guard troops to the California border in protest of a new dam.[9] Arizona finally ratified the compact in 1944, but the disagreements were far from over.[10] 

Arizona also brought a case to the Supreme Court for a related dispute, asking the Supreme Court to allocate how each basin splits water according to the Boulder Canyon Project Act of 1928.[11] Originally filed in 1952, Arizona v. California was not resolved until a Supreme Court opinion in 1963.[12] In the end, the Supreme Court accepted the recommendations of a court-appointed Special Master, whose findings California disagreed with. Of the 7.5 maf allocated to the Lower River Basin, 4.4 maf was allocated to California, 2.8 maf to Arizona and 0.3 to Nevada.[13] The court affirmed each state’s use of their own tributary waters, which Arizona argued for.[14] The case also affirmed the Secretary of the Interior’s authority under the Boulder Canyon Project Act to allocate water amongst the states irrespective of their agreement to a compact.[15] Ultimately, this was a victory for Arizona. 

Colorado River water use has been less contentious since Arizona v. California. The Upper Basin states of Colorado, Utah, Wyoming, and New Mexico signed a contract to divide their 7.5 maf amongst themselves without the need for federal intervention.[16] However, because of comparatively less development in these Upper Basin states, they collectively only use 4.4 maf of their allocated 7.5 maf.[17] California has historically enjoyed the excess and has often historically surpassed its own allocation.[18]

Modern Water Allocation

Until this year, the seven Colorado River states have relied on voluntary agreements and cutbacks to manage water allocation. For example, in 2007, the states agreed to rules which decreased the amount of water that can be drawn from reservoirs when levels are low.[19] In 2019, they agreed to Drought Contingency Plans (DCPs) in the face of waning reservoir levels.[20] It was under this new DCP that the Bureau of Reclamation first announced a drought in August of 2021.[21] Later that December, the Lower Basin states were able to come to an agreement regarding the drought declaration to keep more water in Lake Mead, a reservoir on the Colorado.[22]

However, the December 2021 cutbacks were presumably not enough. In June of 2022, Bureau of Reclamation Commissioner Camille Calimlim Touton testified in front of the Senate Energy Committee about the dire situation on the Colorado.[23] She testified that Lake Powell and Lake Mead, both reservoirs on the Colorado, cannot sustain the current level of water deliveries.[24] Commissioner Tounton gave the seven states 60 days to agree how to conserve 2 to 4 maf.[25] 

Underlying this recent situation is the megadrought that the western United States has suffered since 2000.[26] The last 20 years have been the driest two decades in the past 1200 years.[27] The Colorado River states have become remarkably adept at conserving water in that time. For example, the Las Vegas basin’s population has grown by 750,000 in the past 20 years, but its water usage is down 26%.[28] Earlier this year, Los Angeles banned lawn watering to only one day a week, much to the chagrin of Southern California’s most famous residents.[29] 

Commissioner Tounton’s 60 day deadline came and went without an agreement.[30] During a speech on August 15th of this year, Commissioner Tounton mandated that the seven states have to cut their water usage by 1 maf, roughly the amount of water usage of four million people.[31] However, the cuts were not proportioned equally. Arizona was mandated to cut its water by 21% because of the old water agreements, while California was not required to make any.[32]

More recently on October 5th, several California water districts volunteered cuts of almost one-tenth of their total allocation.[33] California conditioned these cuts upon other states agreeing to similar reductions, as well as on incentives from the federal government.[34] California’s cuts are significant, representing roughly 0.4 maf of the 1 maf that Commissioner Tounton asked states to conserve in her August 15th statement.[35] This represents a bold, good-faith move considering California was not mandated to make any. However, there is no doubt that these ad hoc negotiations are unsustainable. As the drought continues, Colorado River water policy will have implications on how food is grown and where people live. The 40 million people that live in the American Southwest may see their day-to-day lives affected if a solution is not crafted. Ultimately, this situation is far from over as states are forced to come to grips with a new water and climate reality.

Notes

[1] The Journal, The Fight Over Water In The West, Wall Street Journal, at 00:50 (Aug. 23, 2022) (downloaded using Spotify).

[2] Luke Runyon, 7 states and federal government lack direction on cutbacks from the Colorado River, NPR (Aug. 27, 2022, 5:00 AM) https://www.npr.org/2022/08/27/1119550028/7-states-and-federal-government-lack-direction-on-cutbacks-from-the-colorado-riv.

[3] Wyoming, Colorado, Utah, and New Mexico are considered Upper Basin states and California, Arizona and Nevada are the Lower Basin states.

[4] The Journal, supra note 1, at 12:30.

[5] Joe Gelt, Sharing Colorado River Water: History, Public Policy and the Colorado River Compact, The University of Arizona (Aug. 1997), https://wrrc.arizona.edu/publications/arroyo-newsletter/sharing-colorado-river-water-history-public-policy-and-colorado-river.

[6] The Journal, supra note 1, at 8:08.

[7] Gelt, supra note 5.

[8] Id.

[9] Nancy Vogel, Legislation fixes borders wandering river created; Governors of Arizona, California sign bills to get back land the Colorado shifted to the wrong state, Contra Costa Times, Sept. 13, 2002.

[10] Gelt, supra note 5.

[11]  Arizona v. California, 373 U.S. 546 (1963).

[12] Supreme Court Clears the Way for the Central Arizona Project, Bureau of Reclamation https://www.usbr.gov/lc/phoenix/AZ100/1960/supreme_court_AZ_vs_CA.html.

[13] Arizona v. California, 373 U.S. 546, 565, 83 S. Ct. 1468, 1480 (1963).

[14] Id.

[15] Id.

[16] Gelt, supra note 5.

[17] Heather Sackett, Water managers set to talk about how to divide Colorado River, Colorado Times (Dec. 13, 2021) https://www.steamboatpilot.com/news/water-managers-set-to-talk-about-how-to-divide-colorado-river.

[18] Gelt, supra note 5.

[19] Lower Colorado River States Reach Agreement to Reduce Water Use, Renewable Natural Resources Foundation (Feb. 4, 2022) https://rnrf.org/2022/02/lower-colorado-river-states-reach-agreement-to-reduce-water-use/.

[20] Id.

[21] Id.

[22] Id.

[23] Marianne Goodland, Reclamation official tells Colorado River states to conserve up to 4 million acre-feet of water, Colorado Politics(June 15, 2020) https://www.coloradopolitics.com/energy-and-environment/reclamation-official-tells-colorado-river-states-to-conserve-up-to-4-million-acre-feet-of/article_376a907a-ece6-11ec-b0ba-6b2e72447497.html.

[24] Id.

[25] Id.

[26] Ben Adler, ‘Moment of reckoning:’ Federal official warns of Colorado River water supply cuts, Yahoo News (June 15, 2020) https://news.yahoo.com/moment-of-reckoning-federal-official-warns-of-colorado-river-water-supply-cuts-171955277.html.

[27] Id.

[28] The Journal, supra note 1, at 5:50.

[29] Id. at 6:10.

[30] Id. at 8:55.

[31] Id. at 10:05.

[32] Id.

[33] Marketplace, Why women have been left behind in the job recovery, American Public Media, at 11:35 (Oct. 6, 2022) (downloaded using Spotify).

[34] Id.

[35] Ian James, More water restrictions likely as California pledges to cut use of Colorado River supply, L.A. Times, (Oct. 6, 2022) https://www.latimes.com/california/story/2022-10-06/southern-california-faces-new-water-restrictions-next-year.

Making Moves on Marijuana: President Biden and Minnesota Update Marijuana Laws in 2022

October 23, 2022
Administrative Law, Employment Law, Food and Drug Law, Health Law, Public Health

Emma Ehrlich, MJLST Staffer

Federal Pardoning 

Earlier this month, President Biden announced that he would be pardoning anyone with a federal conviction due to simple marijuana possession charges. This will affect approximately 6,500 people on the federal level, plus thousands of others who were convicted in the District of Columbia. However, this pardon does not cover anyone involved in the actual sale of marijuana or anyone convicted under state possession laws, meaning it affects only a subsection of those who have been convicted of marijuana related charges. The administration’s goal was to give a clean slate to those who were struggling to find housing or employment due to a possession charge, and to encourage state legislatures to do the same. 

The second half of President Biden’s announcement was to task the Attorney General with reviewing the federal government’s categorization of marijuana as a Schedule 1 drug, which President Biden pointed out is currently the same categorization as heroin. Drugs are supposed to be assigned to schedules based on their medical uses and addictive qualities. The Drug Enforcement Agency (“DEA”) currently categorizes marijuana as a “drug[] with no currently accepted medical use and a high potential for abuse.” The U. S. Food and Drug Administration (“FDA”) explains on their website, almost in a regretful tone, that only four cannabis drugs have been approved by the FDA, one containing CBD and the other three containing synthetically derived THC. This categorization issue is not new, but because legislation regarding marijuana is changing rapidly federal agencies have had to play catch up with the law.  

Minnesota and Beyond 

Meanwhile, the state of Minnesota is still chugging along in terms of marijuana legalization. In July of this year, the state of Minnesota legalized the production and sale of edibles containing 5-mg of THC, which can now be purchased by adults in bags containing no more than 50-mg of THC. This sounds like good news, but many state residents are baffled at the lack of a tax provision in the new state law. The University of Maryland actually did a study on Minnesota’s potential for taxing cannabis, and determined that if the newly legalized edibles were taxed at the same rate as Michigan taxes, the state could have collected over $40 million. Given this high estimate, it is not out of the question that a tax on marijuana will be implemented in the future. 

Minnesotan employers were similarly not thrilled when the law passed as they felt ill equipped to update their drug policies. Employers “can bar workers from using, possessing, and being under the influence of THC during work hours or in the workplace,” as well as conduct “random drug testing for safety-sensitive positions” and “employees suspected of being intoxicated.” The gray area exists in the employer’s ability to hire and fire based on an applicant or employee’s use of marijuana outside of work. It is currently illegal to make hiring and firing decisions based on tobacco usage or alcohol consumption, and it is unclear if marijuana will be treated in the same manner. The added layer to marijuana testing is that a positive drug test for marijuana does not mean an employee consumed THC right before work since THC lingers in the body for so long. Thus, an employee could test positive for mairjuana at work even if they had used the drugs days ago and were no longer feeling its effects. Though the employee would have ingested the drug legally, they may not be considered for a job position or could be fired from a job they already hold. This is the type of issue that has led a number of municipalities in Minnesota to put a pause on the sale of the state legalized edibles. In contrast, California passed a law just last month protecting employees, apart from some exceptions, from being discriminated against based on their marijuana usage when not at work. What might be a little concerning is that California made recreational marijuana legal in 2016, and this law won’t go into effect until 2024, meaning there was an eight year gap in the legislation. Regardless, this may serve as the beginning of a pattern, pointing to what Minnesota may do down the line. 

In 2020 New Jersey passed a law legalizing recreational marijuana use which went into effect in April of this year. Similarly to California, part of the law protects workers from being discriminated against because of their marijuana use outside of work. However, Walmart and Sam’s Club have continued to administer drug tests to job applicants to search for traces of marijuana, a practice that has gotten them into legal trouble in New Jersey. Walmart is arguing that only the state Cannabis Regulatory Commission can enforce the new employment law, and that this case should be dismissed because it was brought by individuals. Courts in other states in which similar laws have been passed have issued decisions that oppose Walmart’s position, ruling that individual workers can sue under the law. It seems that Minnesota is not the only state that has enacted fuzzy recreational drug use laws that directly affect employers and employees. 

On the bright side of this employment confusion, many appreciate the baby step the Minnesota legislature has taken to legalize marijuana use. The state has been in dire need of updated marijuana legislation, and the hope is that continuing this legalization process will lessen the disparities between black and white arrests for marijuana possession. This change is necessary, because as of 2020 Minnesota was found to rank 8th in the United States for largest racial disparities in marijuana possession arrests. In 2021, the Minnesota Bureau of Criminal Apprehension released data showing that out of the over 6,000 marijuana related arrests made in the state, 90% were for simple possession charges, and a black person was almost five times more likely to be arrested for these types of charges than a white person. This statistic is down from almost eight times more likely back in 2010, but is still extremely present. 

In Conclusion

President Biden’s pardon is just a beginning step towards moving the US forward on marijuana legislation. Though states such as Minnesota are moving in the right direction by gradually legalizing recreational marijuana use, the laws are often unclear and lead to a multitude of logistical issues like those seen in the employment sector. Regardless, making continued progress is important to the U.S. for many reasons and is crucial for helping to lessen racial arrest disparities. Hopefully this pardon will have the effect the administration aimed for and will encourage more state legislatures to update their policies on marijuana usage.

 

 

Meta Faces Class Action Lawsuits Over Pixel Tool Data Controversy

October 22, 2022
Cyber Security, Data, Food and Drug Law, Health Law, Internet, Litigation, Privacy, Social Media

Ray Mestad, MJLST Staffer

With a market capitalization of $341 billion, Meta Platforms is one of the most valuable companies in the world.[1] Information is a prized asset for Meta, but how that information is acquired continues to be a source of conflict. Their Meta “Pixel” tool is a piece of code that allows websites to track visitor activity.[2] However, what Meta does with the data after it is acquired may be in violation of a variety of privacy laws. Because of that, Meta is now facing almost fifty class action lawsuits due to Pixel’s use of data from video players and healthcare patient portals.[3]

What is Pixel?

Pixel is an analytical tool that tracks visitor actions on a website.[4] In theory, the actions that are tracked include purchases, registrations, cart additions, searches and more. This information can then be used by the website owners to better understand user behavior. Website owners can more efficiently use ad spend by tailoring ads to relevant users and finding more receptive users based on Pixel’s analysis.[5]

In the world of search engine optimization and web analysis tools like Pixel are common, and there are other sites, like Google Analytics, that provide similar functions. However, there are two key differences between these other tools and Pixel. First, Pixel has in some cases accidentally scraped private, identifiable information from websites. Second, Pixel can connect that information to the social profiles on their flagship website, Facebook. Whether intentionally or accidentally, Pixel has been found to have grabbed personal information beyond the simple user web actions it was supposed to be limited to and connected them to Facebook profiles.[6]

Pixel and Patient Healthcare Information

It’s estimated that, until recently, one third of the top 100 hospitals in the country used Pixel on their websites.[7] However, that number may decrease after Meta’s recent data privacy issues. Meta faced both criticism and legal action in the summer of 2022 for its treatment of user data on healthcare websites. Pixel incorrectly retrieved private patient information, including names, conditions, email addresses and more. Meta then targeted hospital website users with ads on Facebook, using the information Pixel collected from hospital websites and patient portals by matching user information with their Facebook accounts.[8] Novant Health, a healthcare provider, ran advertisements promoting vaccinations in 2020. They then added Pixel code to their website to evaluate the effectiveness of the campaign. Pixel proceeded to send private and identifiable user information to Meta.[9] Another hospital (and Meta’s co-defendant in the lawsuit), the University of California San Francisco and Dignity Health (“UCSF”), was accused of illegally gathering patient information via Pixel code on their patient portal. Private medical information was then distributed to Meta. At some point, it is claimed that pharmaceutical companies then gained access to this medical information and sent out targeted ads based thereon.[10] That is just one example – all in all, more than 1 million patients have been affected by this Pixel breach.[11] 

Pixel and Video Tracking

The problems did not stop there. Following its patient portal controversy, Meta again faced criticism for obtaining protected user data with Pixel, this time in the context of video consumption. There are currently 47 proposed class actions against Meta for violations of the Video Privacy Protection Act (the “VPPA”). The VPPA was created in the 1980’s to cover videotape and audio-visual materials. No longer confined to the rental store, the VPPA has now taken on a much broader meaning after the growth of the internet. 

These class actions accuse Meta of using the Pixel tool to take video user data from a variety of company websites, including the NFL, NPR, the Boston Globe, Bloomberg Law and many more. The classes allege that by collecting video viewing activity in a personally identifiable manner without consent (matching Facebook user IDs to the activity rather than anonymously), so Pixel users could target their ads at the viewers, Pixel violated the VPPA. Under the VPPA Meta is not the defendant in these lawsuits, but rather the companies that shared user information with Meta.[12]

Causes of Action

The relatively new area of data privacy is scarcely litigated by the federal government due to the lack of statutes protecting consumer privacy on the federal level. Because of that, the number of data protection civil litigants can be expected to continue to grow. [13] HIPAA is the Health Insurance Portability and Accountability Act, an act created in 1996 to protect patient information from disclosure without patient consent. In the patient portal cases, HIPAA actions would have to be initiated by the US government. Claimants are therefore suing Meta under consumer protection and other privacy laws like the California Confidentiality of Medical Information Act, the Federal Wiretap Act, and the Comprehensive Computer Data Access and Fraud Act instead.[14] These state Acts allow individuals to sue, when under Federal Acts like HIPPA, the Government may move slowly, or not at all. And in the cases of video tracking, the litigants may only sue the video provider, not Meta itself.[15] Despite that wrinkle of benefit to Meta, their involvement in more privacy disputes is not ideal for the tech giant as it may hurt the trustworthiness of Meta Platforms in the eyes of the public.

Possible Outcomes

If found liable, the VPPA violations could result in damages of $2,500 per class member.[16] Punitive damages for the healthcare data breaches could run in the millions as well and would vary state to state due to the variety of acts the claims are brought in violation of.[17] Specifically, in the UCSF data case class members are seeking punitive damages of $5 million.[18] One possible hang-up that may become an issue for claimants are arbitration agreements. If the terms and conditions of either hospital patient portals or video provider websites contain arbitration clauses, litigants may have difficulty overcoming them. On the one hand, these terms and conditions may be binding and force the parties to attend mandatory arbitration meetings. On the other hand, consumer rights attorneys may argue that consent needs to come from forms separate from online user agreements.[19] If more lawsuits emerge due to the actions of Pixel, it is quite possible that companies will move away from the web analytics tools to avoid potential liability. It remains to be seen whether the convenience and utility of Meta Pixel stops being worth the risk the web analytics tools present to websites.

Notes

[1] Meta Nasdaq, https://www.google.com/finance/quote/META:NASDAQ (last visited Oct. 21, 2022).

[2] Meta Pixel, Meta for Developers, https://developers.facebook.com/docs/meta-pixel/.

[3] Sky Witley, Meta Pixel’s Video Tracking Spurs Wave of Data Privacy Suits, (Oct. 13, 2022, 3:55 AM), Bloomberg Law, https://news.bloomberglaw.com/privacy-and-data-security/meta-pixels-video-tracking-spurs-wave-of-consumer-privacy-suits.

[4] Meta Pixel, https://adwisely.com/glossary/meta-pixel/ (last visited Oct. 21, 2022).

[5] Ted Vrountas, What Is the Meta Pixel & What Does It Do?, https://instapage.com/blog/meta-pixel.

[6] Steve Adler, Meta Facing Further Class Action Lawsuit Over Use of Meta Pixel Code on Hospital Websites, HIPPA Journal (Aug. 1, 2022), https://www.hipaajournal.com/meta-facing-further-class-action-lawsuit-over-use-of-meta-pixel-code-on-hospital-websites/.

[7] Id.

[8] Id.

[9] Bill Toulas, Misconfigured Meta Pixel exposed healthcare data of 1.3M patients, Bleeping Computer (Aug. 22, 2022, 2:16 PM), https://www.bleepingcomputer.com/news/security/misconfigured-meta-pixel-exposed-healthcare-data-of-13m-patients/.

[10] Adler, supra note 6.

[11] Toulas, supra note 9.

[12] Witley, supra note 3. 

[13] Id.

[14] Adler, supra note 6.

[15] Witley, supra note 3.

[16] Id. 

[17] Dave Muoio, Northwestern Memorial the latest hit with a class action over Meta’s alleged patient data mining, Fierce Healthcare (Aug. 12, 2022 10:30AM), https://www.fiercehealthcare.com/health-tech/report-third-top-hospitals-websites-collecting-patient-data-facebook.

[18] Id.

[19] Witley, supra note 3.



Digital Literacy, a Problem for Americans of All Ages and Experiences

May 10, 2022
COVID-19, Cryptocurrency, Cyber Security, Data, Education, Ethics, Internet, Psychology, Sociology

Justice Shannon, MJLST Staffer

According to the American Library Association, “digital literacy” is “the ability to use information and communication technologies to find, evaluate, create, and communicate information, requiring both cognitive and technical skills.” Digital literacy is a term that has existed since the year 1997. Paul Gilster coined Digital literacy as “the ability to understand and use information in multiple formats from a wide range of sources when it is presented via computers.” In this way, the definition of digital literacy has broadened from how a person absorbs digital information to how one develops, absorbs, and critiques digital information.

The Covid-19 Pandemic taught Americans of all ages the value of Digital literacy. Elderly populations were forced online without prior training due to the health risks presented by Covid-19, and digitally illiterate parents were unable to help their children with classes.

Separate from Covid-19, the rise of crypto-currency has created a need for digital literacy in spaces that are not federally regulated.

Elderly

The Covid-19 pandemic did not create the need for digital literacy training for the elderly. However, the pandemic highlighted a national need to address digital literacy among America’s oldest population. Elderly family members quarantined during the pandemic were quickly separated from their families. Teaching family members how to use Zoom and Facebook messenger became a substitute for some but not all forms of connectivity. However, teaching an elderly family member how to use Facebook messenger to speak to loved ones does not enable them to communicate with peers or teach them other digital literacy skills.

To address digital literacy issues within the elderly population states have approved Senior Citizen Technology grants. Pennsylvania’s Department of Aging has granted funds to adult education centers for technology for senior citizens. Programs like this have been developing throughout the nation. For example, Prince George’s Community College in Maryland uses state funds to teach technology skills to its older population.

It is difficult to tell if these programs are working. States like Pennsylvania and Maryland had programs before the pandemic. Still, these programs alone did not reduce the distance between America’s aging population and the rest of the nation during the pandemic. However, when looking at the scale of the program in Prince George’s County, this likely was not the goal. Beyond that, there is a larger question: Is the purpose of digital literacy for the elderly to ensure that they can connect with the world during a pandemic, or is the goal simply ensuring that the elderly have the skills to communicate with the world? With this in mind, programs that predate the pandemic, such as the programs in Pennsylvania and Maryland, likely had the right approach even if they weren’t of a large enough scale to ensure digital literacy for the entirety of our elderly population.

Parents

The pandemic highlighted a similar problem for many American families. While state, federal, and local governments stepped up to provide laptops and access to the internet, many families still struggled to get their children into online classes; this is an issue in what is known as “last mile infrastructure.”During the pandemic, the nation quickly provided families with access to the internet without ensuring they were ready to navigate it. This left families feeling ill-prepared to support their children’s educational growth from home. Providing families with access to broadband without digital literacy training disproportionately impacted families of color by limiting their children’s growth capacity online compared to their peers. While this wasn’t an intended result, it is a result of hasty bureaucracy in response to a national emergency. Nationally, the 2022 Workforce Innovation Opportunity Act aims to address digital literacy issues among adults by increasing funding for teaching workplace technology skills to working adults. However, this will not ensure that American parents can manage their children’s technological needs.

Crypto

Separate from issues created by Covid-19 is cryptocurrency. One of the largest selling points of cryptocurrency is that it is largely unregulated. Users see it as “digital gold, free from hyper-inflation.”While these claims can be valid, consumers frequently are not aware of the risks of cryptocurrency. Last year the Chair of the SEC called cryptocurrencies “the wild west of finance rife with fraud, scams, and abuse.”This year the Department of the Treasury announced they would release instructional materials to explain how cryptocurrencies work. While this will not directly regulate cryptocurrencies providing Americans with more tools to understand cryptocurrencies may help reduce cryptocurrency scams.

Conclusion

Addressing digital literacy has been a problem for years before the Covid-19 pandemic. Additionally, when new technologies become popular, there are new lessons to learn for all age groups. Covid-19 appropriately shined a light on the need to address digital literacy issues within our borders. However, if we only go so far as to get Americans networked and prepared for the next national emergency, we’ll find that there are disparities between those who excel online and those who are are ill-equipped to use the internet to connect with family, educate their kids, and participate in e-commerce.

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