Category: Blog Posts

Fraudulent Nursing Degree Scheme Leads to Charges

Kendall Warden, Class of 2024, Belmont Law

 

Several southern nursing schools are under fire after recent reports disclosed that more than 7,600 fake nursing degrees and transcripts were sold to “aspiring nurses.” During the five-year scheme, purchasers spent a total of $114 million dollars on the fraudulent degrees and transcripts. The average cost of such degrees amounted between $10,000 and $15,000. These fake nursing degrees issued by actual, real nursing schools qualified purchasers to take the National Council Licensure Examination for Registered Nurses (NCLEX). Roughly 2,400 fraudulent degree purchasers successfully passed the NCLEX and were able to obtain employment as registered nurses. These nurses are likely to lose their nursing licenses.

 

The Department of Justice and Department of Health and Human Services Office of Inspector General have initiated an investigation they dubbed “Operation Nightingale.” Currently, twenty-five individuals affiliated with three Florida nursing schools have been charged in connection to this investigation. The individuals involved face up to twenty years in prison for their participation in the fraud scheme. While the purchases who managed to pass the NCLEX and obtain licensure will likely lose their licenses, it is unlikely they will be federally prosecuted.

 

However, state licensing boards are calling for action against the nurses who fraudulently obtained their licensure. Licensure annulment and revocation could be the worst punishment received by diploma purchasers in this fraud scheme – criminal charges are not currently being pursued against purchasers. Specifically, Delaware, Georgia, and Texas are initiating disciplinary actions against such individuals. The Delaware Board of Nursing reportedly annulled twenty-six individuals’ nursing licenses. Georgia’s Board of Nursing directly asked twenty-two nurses who obtained their licensure fraudulently to come forward and surrender their licenses voluntarily, but many instead retained counsel to attempt to fight the possibility of licensure revocation. The VA Press Secretary Terrence Hayes told WSB-TV that three of the nurses worked at a Veterans Affairs hospital and have since been removed from the medical center.

 

The U.S. Attorney for the Southern District of Florida, Markenzy Lapointe, expressed the overarching public policy concern, besides an obvious public safety issue, that this situation “tarnishes the reputation of nurses who actually complete the demanding clinical and course work required to obtain their professional licenses and employment.” She also raised concern for the erosion of public trust in the health care system because of fraud schemes like this one.

 

It will be interesting to watch this investigation develop, as it is unclear if or in what manner, a route to licensure will be provided to those purchasers who wish to pursue a valid nursing degree.

 

 

 

Sources: – https://www.americanbar.org/groups/health_law/section-news/2023/february/nursing-boards-seek-action-in-response-to-doj-charges-in-fraudulent-diploma-scheme/ – https://www.justice.gov/usao-sdfl/pr/fraudulent-nursing-diploma-scheme-leads-federal-charges-against-25-defendants – https://www.beckershospitalreview.com/nursing/georgia-asks-22-nurses-to-surrender-licenses-amid-degree-scheme-probe?utm_campaign=bhr&utm_source=website&utm_content=related – https://www.americanbar.org/groups/health_law/section-news/2023/february/people-in-florida-charged-with-fake-nursing-diploma-scheme/ – https://www.npr.org/2023/01/27/1152034256/fake-nursing-diplomas-scheme-arrests-florida

The Present Landscape of COVID Vaccine Requirements for Children

Azariah Dileo, Class of 2024, Belmont Law 

State governments have broad discretion when determining vaccine requirements for students. States have historically used mandatory vaccine requirements for students because it has been seen as the most efficient way of achieving herd immunity. Herd immunity is when a high threshold percentage of a community has immunity (natural or through vaccination) against a particular virus or disease. The more contagious a particular virus or disease is, the higher the threshold immunity in the population needs to be in order to achieve herd immunity.  

 

Since the onset of the COVID pandemic, public health and government officials have unified to achieve herd immunity. Despite this goal, states have not wholly embraced using the most effective tool to achieve these aims: mandatory school vaccinations. Currently, fifty-seven percent of children between six months old infants and seventeen-year-old minors have not received any dosage among the available COVID vaccines. 

 

California was one of the few states that considered requiring vaccines for public and private school children. Other states have generally seen California as a trendsetter in its pandemic response efforts. For example, California was the first state to issue a statewide stay-at-home order on March 19, 2020. Once California issued the stay-at-home order, many states followed suit shortly thereafter. Despite being a leader among the states in its pandemic response efforts, other states did not take up California’s public health approach to student vaccination requirements.  

 

There are several reasons that potentially explain why states are not requiring student COVID vaccinations despite their awareness of the benefits that herd immunity promises. Firstly, vaccination requirements typically have the most success when officials are attempting to close a narrow compliance gap. For example, in November 2022, the District of Columbia decided not to enforce its vaccine mandate until the 2023-2024 school year because the current vaccination rate for students remains at forty-four percent. 

 

Secondly, the public health narrative surrounding COVID vaccines has shifted. Originally, public health officials and vaccine producers equated the vaccine to polio, measles, mumps, etc. vaccines, which require minimal, set doses of the vaccines before the public no longer had to worry about their individual and collective immunity. However, given the rate at which the COVID virus mutates, the COVID vaccination conversation has shifted from minimal, set doses to annual boosters, which mimic the annual flu-shot approach. An annual vaccination approach in combination with a mandatory student COVID vaccine policy would create logistic and administrative difficulties for schools trying to assess and enforce compliance. 

 

Thirdly, the public does not perceive that children are at risk of contracting COVID. When children do contract COVID, they are less likely to experience serious illness and even less likely to experience death. Nonetheless, some people who support student COVID vaccine requirements argue that the requirements may promote overall immunization against other diseases (i.e. chickenpox, measles, tetanus, etc.), may protect the children as they advance into adulthood, and may prevent the virus from further mutations.  

 

According to an August 2022 Gallup poll, less than a majority of survey respondents, forty-eight percent, agreed that states should mandate COVID vaccination among students. Perhaps the fifty-two percent who do not support the student vaccination efforts no longer prioritize COVID as a public health issue. In weighing state responses to requiring children’s COVID vaccinations, perhaps another question emerges—is COVID’s recession from the public’s consciousness premature, timely, or is it long overdue? 

 

Sources: 

COVID-19 Vaccines: Who will be exempted from a COVID-19 vaccine? by Jessica Kriegsfeld 

Mandatory School Vaccinations: The Role of Tort Law by Anthony Ciolli, JD, MBE 

Herd immunity and COVID-19: What you need to know by Mayo Clinic Staff 

California backs down from requiring COVID-19 vaccine to attend schools by CBS News Bay Area 

Governor Gavin Newsom Issues Stay at Home Order by California.gov 

Necessity of 2 Doses of the Pfizer and Moderna COVID-19 Vaccines by Edward H. Livingston, MD 

Ransomware Strikes Again: Health Records for 2,000 Students is Leaked onto the Dark Web

Shane Richards, Class of 2023, Belmont Law

In September of last year, the Los Angeles Unified School District was the target of a ransomware attack that significantly disrupted its information technology systems. Being the second biggest school district in the United States, this attack made national headlines and prompted responses from the FBI and Homeland Security, among other federal agencies. This attack was one of many ransomware attacks targeting school districts across the United States. In the face of this attack, the Los Angeles United School District refused to pay the ransom, the amount of which was not disclosed to the public, stating that paying the ransom “never guarantees the full recovery of data…”

Several months later, it came to light that the group responsible has leaked this information onto the Dark Web, that deep, uncatalogued section of the internet that is only accessible via special tools. Specially, the sensitive health records for “about 2,000 current and former Los Angeles school students.” Included among these records were drivers’ licenses, Social Security numbers, assessment records, and COVID-19 results. The majority of the leaked health information relates to special education students. The information leaked about the special education students includes their academic performance, disciplinary records, and medical histories.

This attack, among many others of a similar nature, shows just how vulnerable the digitalization of sensitive information has become. Hackers are targeting schools, private companies, and hospitals at increasing rates, demanding double ransoms. The first ransom is for unencrypting the information, which could be completely lost otherwise. The second ransom is to keep the information from being published to places like the Dark Web. However, nothing guarantees that paying the ransom will prevent any of the loss of the information nor that the

information won’t be leaked for any nefarious actors to misuse. Although, the specific ransomware gang responsible for the Los Angeles attack is “reasonable” in negotiating their ransoms.

It seems that these ransomware gangs have three initial routes into these public systems. The first is by phishing employee emails, whereby they trick current employees into opening the door. Their second method is to take advantage of dormant account credentials left by former employees. The final way in is by exploiting known vulnerabilities in old software. Once in, these hackers then use techniques “living off the land,” which take piggy back off of legitimate tools to do the hackers’ dirty work, to circumvent detection. It’s unclear exactly which method was utilized in the attack on the Los Angeles United School District; however, the gang responsible has been known to utilize all these methods.

All of these methods used by ransomware hackers are supposedly preventable. However, the number of attacks are increasing year upon year and these attacks are targeted at any institution that has digitized its vital information. It’s not just health care information held by hospitals or medical providers that is at danger, but any third party institution, public or private, need to be prepared to take measures to prevent such attacks. The Los Angeles attack is a good case study in exactly the kind of consequences that can befall an institution and what lays in store for the real victims of such an attack—the patients and students that trust these institutions with their vital information.

Works Cited: https://today.westlaw.com/Document/I47ffbf80b3bc11ed9d67b7a2e9b19096/View/FullText.html?transitionType=CategoryPageItem&contextData=(sc.Default)&firstPage=true https://www.foxbusiness.com/technology/los-angeles-school-district-reveals-ransomware-gang-leaked-thousands-student-health-records-online https://www.foxnews.com/us/los-angeles-unified-school-district-targeted-ransomware-attack https://www.malwarebytes.com/blog/business/2023/01/5-facts-about-vice-society-the-ransomware-group-wreaking-havoc-on-k-12-schools https://www.cnn.com/2022/10/01/us/los-angeles-unified-school-district-ransomware-attack/index.html

Athena Nursing Homes Under Fire

Kendall Warden, Class of 2024, Belmont Law

In health law section news, the American Bar Association reported that Connecticut-based Athena Health Care Systems is facing major trouble. The organization is facing a myriad of grievances from all sides of the business: complaints from three New England states over nursing home conditions and failure to pay staff, lawsuits from six staffing agencies alleging almost $150,000 in owed wages, a separate suit alleging Athena owes more than $2 million to a different staffing agency, the largest fine ever issued in Massachusetts – $1.75 million – and over 500 complaints in Connecticut alone in less than a year.

Connecticut, Massachusetts, and Rhode Island have placed Athena Health Care Systems under scrutiny after consistently receiving complaints regarding nursing home conditions in each state. Athena runs over forty long-term care facilities in the region, accounts for approximately 70% of nursing home residents in Connecticut alone and may now be running afoul of complying with Medicare or Medicaid compliance standards.

Six temporary staffing agencies sued Athena for allegedly failing to pay almost $150,000 in wages for the employees the staffing agencies provided to offset employee shortages during the pandemic. A separate staffing agency filed suit against Athena claiming over $2 million for temporary employees the company provided to Athena. A further lawsuit has been filed against Athena by an insurance company, “alleging that Athena, a self-insured company, has failed to pay more than $6 million in health insurance claims from its employees.” Such claims caused state officials to contact the U.S Department of Labor to begin an investigation.

The Massachusetts Attorney General’s office saddled Athena with the largest fine ever issued in the state because the organization was caught admitting residents with substance abuse issues without the ability to provide necessary and appropriate treatment. This practice by Athena apparently led to numerous overdoses. Furthermore, several consent orders have been issued to address staffing issues and patient safety concerns such as unsanitary conditions.

Alarmingly, Athena is also facing a wrongful death suit after a resident in one of the organization’s Massachusetts nursing homes was murdered in the facility. The decedent’s roommate slammed his walker against the decedent’s head repeatedly before staff intervened, eventually leading to his death.

Regarding the 518 complaints received by Athena, several report residents being forced to remain in wet undergarments, missing meals, not receiving appropriate medications, and being stuck in bed, among others. Lack of access to care to is the most common complaint received by Athena Health Care Systems. These complaints most definitely stem from the organization being highly understaffed.

In response to complaints, lawsuits, and fines, Athena’s owner, “Lawrence Santilli, acknowledged the company has had financial difficulties that have ‘undermined the quality of care’ in some facilities. ‘For Athena, which serves thousands of patients daily across its 45 facilities with thousands of employees, these unprecedented challenges and expenses and the resulting severe staffing shortages have resulted in significantly higher expenses and have put a strain on resources,’ Santilli said in an emailed statement” to the CT Mirror.

In an attempt to change course, Athena hired a registered nurse to submit reports to the Department of Public Health for a minimum of six months. The organization also halted admissions in an effort to resolve staffing and resource shortages.

 

 

https://www.americanbar.org/groups/health_law/section-news/2023/january/lawsuits-put-pressure-on-athena-nursing-homes/ https://ctmirror.org/2023/01/15/ct-athena-health-systems-nursing-home-lawsuit-massachusetts-rhode-island-connecticut/

NEW FEDERAL LAW GOVERNING THE MANUFACTURE AND DISTRIBUTION OF COSMETICS

Azariah Dileo, Class of 2024, Belmont Law

 

Until December 29th of this past year, the Federal Food, Drug, and Cosmetic Act (FD&C) and the Fair Packaging and Labeling Act (FPLA) were the only federal laws that regulated cosmetic manufacturing and distribution processes within the United States. Section 201(i) of the FD&C Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Cosmetics, according to the FD&C Act, do not include soaps, dietary supplements, or products that are used for therapy purposes.

 

Last month, President Biden signed a bill that added one more federal law that would govern the manufacturing and selling of cosmetics within the United States: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)—the first update to cosmetics regulations within the United States in eighty years. MoCRA’s purpose is to regulate the manufacturing and processing of cosmetics that are distributed and sold within the country. To meet MoCRA’s initial requirements, every existing cosmetic manufacturing or processing facility must register with the Food and Drug Administration (FDA) no later than December 29, 2023. Any new manufacturing or processing facilities that come into existence after December 29, 2023, must register with the FDA within sixty days after commencing operations.

 

MoCRA also tasks the FDA with creating regulations for cosmetic production facilities. To minimize any undue economic burdens, MoCRA requires the FDA to formulate its regulations flexibly, keeping in mind that what might be practicable for a larger business may not be practicable for a small business. The FDA has a three-year deadline (2025) by which it must formulate MoCRA regulations for good manufacturing practices.

 

In addition to enabling the FDA to promulgate regulations, MoCRA sets requirements for cosmetic manufacturers, packers, or distributors who are listed on a product’s label—MoCRA names such an entity a “reasonable person”. A reasonable person must meet several of MoCRA’s requirements, but here are a few. A reasonable person is responsible for providing the FDA with a list of each cosmetic product and corresponding cosmetic ingredient lists. Additionally, a reasonable person must provide an “adequate substantiation of [the] safety” of their cosmetic products. A reasonable person typically meets this requirement by providing the FDA with research or other evidence that the ingredients in their product are safe for the expected use. If a consumer experiences a “serious adverse event” related to using the cosmetic within fifteen days of receiving the cosmetic product, the reasonable person has a duty to report the event to the FDA. 

 

With MoCRA being the first update in federal laws governing cosmetic production in eighty years, its impact is vast. In addition to the changes that MoCRA brings, described above, it has additional implications for the FDA, preemption of state laws, and other production practices.

Works Cited:

Reckoning with Ransoms: The Dangers of Relying on Electronic Patient Data Increases

Shane Richards, Class of 2023, Belmont Law

The issues with using paper forms and records instead of electronic versions are numerous and numerous to anyone who has ever worked in an office. Even in my limited experience of working at a law firm, I have learned that paper files have their downsides. They can be difficult to manage. The document you need can easily be lost amidst thousands of other paper documents and hundreds of other file folders being tossed around, shared among a busy office. “Who has the Johnson file?” and similar questions can often be heard, sending all nearby attorneys rummaging around their desks to figure out if they were the ones to misplace the file. Physical files also take up a lot of space and it is generally more time consuming to comb through a paper file to find just that one document you need. These questions of ease make using electronic records alluring enough, and that still leaves out the security questions. Is it not relatively easy for a nefarious actor to take a peek at a sensitive, misplaced file?

Many of these issues are solved by creating electronic files. Even doing something as simple as putting documents on a program like Google Docs cuts down on paper, makes locating them easier, and improves security. Other systems can put further password protections on sensitive records and take it however many steps further a company may desire. Only one who is supposed to look at it can look at it—that is the logic. One does not need to look far to this same reasoning being used to move medical records from cumbersome paper form to a sleek electronic manifestation. Another bonus unique to the context of electronic medical records is the added shareability. The possibility of easily sharing medical records from one healthcare provider to another is theoretically invaluable. Several pieces of legislation in this new electronic age, like the 21st Century Cures Act, has been pushing the health care industry in the direction of relying on electronic databases for the storage and access of medical records.

However, it may not be more secure at all. New data being published in Journal of American Medical Association Health Forum and cited by Westlaw Today, show that health care providers are being faced by a grave new threat: ransomware attacks. In the days of old, a nefarious actor had to physically walk into a hospital and look at sensitive documents to retrieve personal information. There are many obvious things a hospital can do to combat such an issue. Now, however, with most records being made electronic, a nefarious actor can force a hospital to pay an exorbitant ransom from the comfort of their own homes—and hospitals are struggling to deal with this new paradigm.

As described by Westlaw Today, a ransomware attack is a type of computer malware that “attempts to deny access to data, usually encrypting the data with a key known only to the hacker, until a ransom is paid.” These types of attacks have doubled from 2016 to 2021, totaling 374 ransomware attacks. These attacked impacted almost 42 million people—that’s about 13% of the US population. The ransom being paid or unpaid, only 20% of organization reported that they were able to restore that data, meaning that 80% of data was lost. It can be confirmed that in 16% of these attacks, the stolen information was made public. Those numbers may seem sufficiently worrisome on their own. However, there are reasons to believe the number of attacks are significantly underreported due to regulatory penalties and potential class action lawsuits.

Despite what some would think, it appears that more tech might mean more problems. These developments have created a new frontier of security concerns and threats, with both sides—hacker and hospital—crafting new and unique ways to protect data and to phish for that data. As noted by Westlaw, employee training and education is vital to prevent such attacks. Yet, no one is perfect and even the best trained staff can fall victim to such an attack. The operations of hackers continue to get more sophisticated and someone will be caught off guard eventually. The question then becomes what does a hospital do when all of its data is lost? Should a protocol be in place to

regather and reenter that information? Should the data be regularly backed up to a completely different data base? Is it worth keeping a paper backup of the most important information? Wouldn’t paper versions kept at the hospital bring us back to the paper problems we all know? These are the questions faced health care institutions in the electronic age. Is it worth having these great electronic systems of communicating medical records between institutions if more than 10% of patient information is ransomed and lost, causing treatment delays?

Works Cited: https://today.westlaw.com/Document/Ie811db8098f411eda10787784e3365fb/View/FullText.html?navigationPath=Search%2Fv1%2Fresults%2Fnavigation%2Fi0ad604ad00000185d23511fc1fea453e%3Fppcid%3Dd11156e14e634c908e1f94a21733a4e2%26Nav%3DNEWS%26navQualifier%3DIaaa6fc50694d11eaadfea82903531a62%26fragmentIdentifier%3DIe811db8098f411eda10787784e3365fb%26parentRank%3D0%26startIndex%3D1%26contextData%3D%2528sc.Default%2529%26transitionType%3DSearchItem&listSource=Search&listPageSource=6fcd84139439d4070f29d6971c7d4474&list=ALL&rank=5&sessionScopeId=42ded266c0228fe6f2fa871a406991678c428adf244f503e8b69d87ba02b7156&ppcid=d11156e14e634c908e1f94a21733a4e2&originationContext=Search%20Result&transitionType=SearchItem&contextData=%28sc.Default%29 https://www.softwareadvice.com/resources/pros-cons-paper-charts/ https://goscanstrong.com/2020/12/15/the-problem-with-paper-medical-records/#:~:text=The%20Problem%20With%20Paper%20Medical%20Records%201%20Limited,hard%20to%20read%2C%20and%20difficult%20to%20locate.%20

DOJ Seeks Permanent Injunctive Relief Against Six E-Cigarette Manufacturers

Kendall Warden, Class of 2024, Belmont Law

On October 18, 2022, the DOJ filed complaints against six e-cigarette manufacturers seeking permanent injunctions for violations of the Food and Drug Administration’s premarket review requirements for new tobacco products. Even if a product is already being sold, the Federal Drug, Food and Cosmetic Act requires manufacturers to submit an application for approval. The DOJ is attempting to stop these e-cigarette manufacturers from continuing the illegal manufacture and sale of unauthorized vaping products that have not been approved. So far, this rule has allowed the DOJ to issue over 300 warnings to several e-cigarette manufacturers and prompted many of the manufacturers to remove their products from the market.

 

In the present lawsuits filed in several U.S. District Courts, the complaints allege that the e-cigarette manufacturers, “caused tobacco products to become adultered and misbranded while held for sale after shipment of one or more of their components in interstate commerce.” The complaints further allege that the defendants continued to manufacture, sell, and distribute the adultered and misbranded tobacco products after receiving warning letters from the FDA. These suits are among the first pursuing permanent injunctions of e-cigarette manufacturers for violations of the federal Food, Drug and Cosmetic Act’s premarket review requirements.

 

The six defendant e-cigarette manufacturers are: (1) Seditious Vapours LLC, based in Phoenix, Arizona; (2) Vapor Craft LLC, based in Columbus, Georgia; (3) Lucky’s Convenience & Tobacco LLC, based in Wichita, Kansas; (4) Morin Enterprises Inc., based throughout Minnesota; (5) Super Vape’z LLC, based in Lakewood, Washington; and (6) Soul Vapor LLC, based in Princeton, West Virginia.

 

All six defendants received notice that their products required FDA approval before their products could continue to be sold. However, all six defendants continued to manufacture and sell their e-cigarette products following said notification. None of the defendants attempted to obtain FDA authorization for their e-cigarettes at issue in these lawsuits.

 

Several U.S. attorneys made comments on the current suits. U.S. Attorney Peter D. Leary for the Middle district of Georgia stated that business’s compliance with federal regulations that are put in place to protect consumers is absolutely vital. U.S. Attorney Nick Brown for the Western District of Washington pointed out that the e-cigarette manufacturer in Washington was not only selling potentially adulterated products, but also contributed to a bigger public harm by selling e-cigarettes to underage kids. Finally, Brian King, the director of the FDA’s Center for Tobacco Products, expressed tremendous frustration with e-cigarette manufacturers who repeatedly break the law after being given notice and multiple opportunities to comply.

 

These actions are an important first step in eliminating the illegal sale of unauthorized e-cigarette products. More importantly, these actions are an important step towards decreasing the likelihood of underage kids gaining access to e-cigarettes.

 

 

https://www.justice.gov/opa/pr/justice-department-files-multiple-lawsuits-stop-illegal-sale-unauthorized-vaping-products

https://www.americanbar.org/groups/health_law/section-news/2022/october/doj-seeks-permanent-injunctions-against-e-cig-manufacturers/

https://www.cnn.com/2022/10/18/health/e-cigarette-manufacturers-fda-justice-department

 

Policymakers Overcoming Difficulties in Investing in Public Health Interventions

Azariah Bridgewater, Belmont Class of 2024

Policymakers have two competing interests: making policies that benefit the well-being of the people and getting reelected so that they can continue to make policies that benefit the well-being of the people. These two interests compete when policymakers are looking at whether or not to fund public health interventions. policymakers who support public health interventions use taxpayer dollars for government support that could be going toward an immediate crisis, but instead, the taxpayer dollars go toward a crisis that may happen later in the future or a crisis that may never happen at all. 

 

Through the elective democratic process, the public has the task of determining who will be its policymakers. As such, it is the public’s responsibility to measure the efficacy of current policymakers by looking at the positive and negative impacts the policymakers’ decisions have made on the public. When measuring efficacy is based on far-off events, the public has a harder time evaluating policymakers’ efficacy for the purposes of reelection. 

 

The public is aware that public health investments are a long-term solution to latent problems. However, when a policymaker’s term is much shorter than the time it takes to see a return on policymakers’ investments in public health, policymakers are likely to feel the tension between their two, often-competing aims. To ease the tension, the public needs a clear rubric by which it may hold policymakers accountable.

 

Perhaps that clear rubric is this: transparent, multi-tiered project planning. For example, the success of tobacco control and prevention interventions for youth can usually be measured when the targeted youth become adults. In addition to the macro-level goal of reducing the number of adults that had ever engaged in tobacco use, the intervention program can and should measure the relative increases or decreases in tobacco use among youth of various age-ranged cohorts as compared to that same age range one, two, five, ten, or more years ago. Showing the decrease in tobacco use is an early, measurable goal with a near-immediate outcome by which the public can hold policymakers accountable. 

 

As a public health intervention policy matures, policymakers need only continue following the transparent rubric they presented to the public. For example, after implementing the tobacco control and prevention program for five years, the program should not just show decreases in tobacco use when comparing cohorts. The program should also show data on increased percentages of youth who have never used tobacco at all. And as a twenty-year goal, perhaps the policymakers need to present the public with data on decreased instances of smoking-related lung cancer among the cohorts of youth previously targeted by the tobacco control and prevention intervention efforts. 

 

If ever an intervention falls short of a goal, policymakers can and should reevaluate the public health intervention by modifying one of three things: (1) whether the method of intervention should be modified, (2) whether the goal by which to measure the intervention should be modified, or (3) whether the amount of taxpayer dollars devoted to the intervention should be modified. With transparent rubrics with intervals for reevaluations of public health interventions, the public is well-informed about policymakers’ decisions to invest in long-term goals. When the public is well-informed, policymakers can continue to invest in the future with less tension between their two competing interests. 

 

Works cited: 

https://www.networkforphl.org/news-insights/lets-talk-money-barriers-and-benefits-of-investment-in-public-health/

$4.2 Billion and $13.8 Billion: Major Strides in Combating the Opioid Crisis

Shane Richards, Class of 2023, Belmont Law

Within the past few weeks, major cases involving CVS, Walgreens, Teva, and Walmart, years of litigation, are finally coming to a close. The result: a total of $17 billion in settlement. Teva Pharmaceuticals agreed to settle claims concerning its role in fueling the opioid crisis for $4.2 billion, with an additional $523 million to settle New York specific claims. CVS agreed to pay $5 billion. Walgreens will pay $5.7 billion and Walmart will pony up $3.1 billion. This settlement would be the first one to deal with nationwide retail pharmacy companies. A large portion of this money will go directly to combatting the opioid crisis, alongside other funds recovered in the many similar lawsuits across the country.

These lawsuits and their subsequent settlements have come as the opioid crisis worsened due to the pandemic, with the number of overdoses since 1999 reaching over 650,000. It is not surprising that increasingly immense feelings of hopelessness coupled with being forced indoors for months would lead to an increase in drug use. However, the problem has been made even worse with fentanyl becoming more and more commonplace. This past October, a congressional report found the economic toll of the opioid crisis to be about $1.5 trillion in 2020 alone. Clearly, the situation has not improved and recent events have only made it worse.

Who is to blame for this problem? What is the cause of the crisis? The answer to this question is not simple. It is the definition of multi-faceted problem, from well-meaning doctors overprescribing opioid medication to profit motivated pharmaceutical companies seeking increased sales. One of the several causes comes in the form of careless pharmacies not exercising their due diligence to control the distribution of these drugs. Such loose practices by pharmacies have ignored obvious red flags, allowing these drugs to be diverted into the illicit drug trade. The above-described lawsuits were aimed precisely at dealing with this source of the problem. These lawsuits alleged that major pharmacies like CVS and Walgreens were partially responsible by exercising “reckless, profit-driven dispensing practices,” creating a “public nuisance” for which they need to pay.

Quite frankly, such consequences are long overdue. It is about time that any actor or entity partially responsible for the opioid crisis face serious consequences. This issue has been dragging on for decades. Entire sections of this country are suffering from it. Everyone knows it is a problem even if not everyone is totally familiar with it. It also is not a secret that a major supplier of these drugs are pharmaceutical companies. Additionally, it is not a secret that health care providers and pharmacists play a role in perpetuating this crisis, whether it be by rouge actors taking advantage of the system for personal gain or by incompetence. These actors and companies need to be held accountable for their role in this crisis and, generally speaking, the only way to get a company to pay attention is to hit it where it hurts: its wallet.

Specifically concerning pharmacies, it is not sure exactly how strongly these companies will feel these consequences. First, these settlements come with the caveat that the offending companies may pay these settlements over the course of several years. Second, the yearly net revenues of these companies far and away exceed the amount settling these cases. Nonetheless, it is hoped that these billions of dollars these companies are being forced to spit out will cause them to correct course, in fear that similar suits could happen again. Perhaps, the current trend of lawsuits will help to correct the course with how pharmacies conduct themselves in the face of the crisis, but it ultimately remains to be seen.

Works Cited: https://today.westlaw.com/Document/I0115a6a05a9011eda1339568dfe0149e/View/FullText.html?productData=categoryPageUrl%3AHome%2FWestlawToday%2FWestlawTodayHealthLaw&transitionType=CategoryPageItem&contextData=(sc.Default https://today.westlaw.com/Document/I316e9ca05b7411ed8e7e95fef8071348/View/FullText.html?productData=categoryPageUrl%3aHome%2fWestlawToday%2fWestlawTodayHealthLaw&transitionType=CategoryPageItem&contextData=(sc.Default&firstPage=true&OWSessionId=067bad54b22642dcb96dbbc773c9094e&skipAnonymous=true&bhcp=1 https://www.popsci.com/health/walgreens-cvs-opioid-crisis/ https://www.popsci.com/story/health/cdc-drug-overdose-increase-covid-19-pandemic/ https://hellogiggles.com/news/politics/how-opioid-epidemic-began/#:~:text=Andrew%20Hauput%2C%20Ammon%E2%80%99s%20Head%20of%20Product%20and%20Marketing%2C,media%2C%20see%20and%20talk%20about%20addiction%20and%20addicts. https://www.macrotrends.net/stocks/charts/WMT/walmart/net-profit-margin#:~:text=Walmart%20Net%20Profit%20Margin%20Historical%20Data%20%20,%20%201.40%25%20%2048%20more%20rows%20 https://www.macrotrends.net/stocks/charts/CVS/cvs-health/net-profit-margin#:~:text=CVS%20Health%20Net%20Profit%20Margin%20Historical%20Data%20,%20%202.71%25%20%2048%20more%20rows%20 https://www.macrotrends.net/stocks/charts/WBA/walgreens/net-profit-margin#:~:text=Walgreens%20Net%20Profit%20Margin%20Historical%20Data%20%20,%20%204.76%25%20%2048%20more%20rows%20

WHAT IS THE EFFECT OF THE UNITED STATES RETURNING TO A PRE-ROE ERA

Azariah Bridgewater, Belmont Law, Class of 2024

Earlier this year, the United States Supreme Court (the Court) decided to overturn Roe v. Wade in the case Dobbs v. Jackson Women’s Health Organization. The Court’s Dobbs decision no longer recognized that a federal right existed for a woman to have an abortion prior to the viability of the unborn child. In consequence, the abortion laws states had on the books pre-Roe were suddenly revived. Because pre-Roe state laws had been revived, the legality of abortion returned to its pre-Roe status in each of the fifty states. Therefore, the fight to end or protect abortion was to continue at the state level. In the wake of the Dobbs decision, the various states have fallen across the spectrum of either denying or protecting women’s right to abortion.

Thirteen states have trigger laws that their legislatures designed to have immediate effect in case the Court overturned Roe. Now that the Court has overturned Roe, the following thirteen states’ anti-abortion laws have been triggered: Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, Utah, and Wyoming. In Kentucky, for example, the trigger law that went into effect made it a felony for anyone to perform an abortion unless the abortion was to prevent the mother’s death or serious injury to her internal organs. In North Dakota as another example, it became a felony to perform an abortion unless one of three criteria were met: the mother would likely die from the pregnancy, or rape or incest caused the pregnancy.

The states that did not enact trigger laws but wanted to restrict abortion access have done so (or are in the process of doing so) by two other means: returning to pre-Roe anti-abortion laws or enacting new post-Dobbs legislation restricting abortion. The Court’s 1973 Roe decision froze in place the anti-abortion laws that were on the books by making them ineffective. Those laws were arguably dormant for the past 59 years and revived when the Court overturned Roe in its Dobbs decision. Some states seek to reinforce their old pre-Roe laws. Other states, however, rely on their current legislatures to pass laws that will represent their states anti-abortion stance. 

Not all states want to restrict abortion or go to pre-Roe laws. One method states are employing to protect abortion access is to de-prioritize and de-fund anti-abortion laws. De-prioritization and de-funding have the same goal: for law enforcement and state and local prosecutors to turn a blind eye toward the medical professionals administering abortive procedures and toward women seeking the abortive procedures. States have also begun to enact legislation that prevents law enforcement and prosecutors from holding people criminally liable for breaking an anti-abortion law that it may still have on the books.

Post-Dobbs, the nation seems to be divided. But instead of looking at the issue of abortion uniformly, perhaps we should embrace the division in how each state approaches the issue. The spirited fight for or against abortion is reasonable in light of the heavy moral and ethical questions about who has rights in a pregnancy, is there a hierarchy in the weight of each party’s rights, and do the weights of those rights differ by circumstance. Perhaps the Dobbs decision, returning the question to the state legislatures, will put an end to the heated debate, locally at least. As state legislatures review the issue, there is the looming promise that the citizens who elected the legislative officials will hold them accountable during the next round of elections. 

Sources:

The Network for Public Health, “Using Local Ordinances, Resolutions, and Non-Prosection Measures to Protect Reproductive Health, Published September 1, 2022. https://www.networkforphl.org/news-insights/using-local-ordinances-resolutions-and-non-prosecution-measures-to-protect-reproductive-health/ 

ABA Journal, “What are abortion trigger laws, and where do they stand?”, Published June 30, 2022. https://www.abajournal.com/web/article/what-are-abortion-trigger-laws-and-where-do-they-stand