Author: hljwebcontent

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 

OCR Sends Message of Compliance to Dental Practices in violation of Patient Right of Access Under HIPAA

Kendall Warden, Class of 2024, Belmont Law

On September 20, 2022, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) sent a public message to dental practices in violation of HIPAA Privacy Rule’s patient right of access provision. The OCR did this by publicizing the result of investigations into three dental practices throughout the United States. These investigations concerning patient right of access violations are part of a collective effort to encourage medical providers to remain compliant with the HIPAA Rules and minimize the need for patients to file complaints with OCR to receive their medical records.  

 

In general, the Privacy Rule’s patient right of access provision requires covered entities in possession of protected health information (PHI) to provide individuals access to their PHI upon request. While there is no private right of action for individuals affected by HIPAA Privacy Rule violations, filing a complaint with the OCR gives patients an alternative means of resolving disputes when covered entities fail to timely or adequately provide access to PHI. 

 

The first of the three cases involved Family Dental Care, P.C., located in Chicago, Illinois. A patient of the dental practice requested her full medical record in May 2020, but she received only bits and pieces of her records. After realizing large portions of her records were missing, the patient filed a complaint with OCR on August 8, 2020. During OCR’s investigation, the dental practice provided the patient with the remainder of her medical records. The patient did not receive her full medical records until a complaint had been filed and more than five months had gone by since the initial request. OCR determined that Family Dental Care did not timely provide patient access to the request medical records, and therefore, potentially violated HIPAA Privacy Rule’s patient right of access provision. Family Dental Care ended up paying a $30,000 fine and agreeing to implement a corrective action plan.  

 

The second investigation involved a dental and orthodontics provider located in Georgia, Great Expressions Dental Center of Georgia, P.C. In November 2019, a patient requested her medical records from the dental practice. The practice refused to provide the medical records unless the patient paid $170 copying fee, so the patient filed a complaint with OCR in November 2020. Over a year later, in February 2021, the practice finally provided the patient with her medical records. Through its investigation, OCR determined Great Expressions Dental Center of Georgia failed to provide timely access to the patient’s requested medical records, and its copying fees are unreasonable and not cost-based. Both determinations are potential HIPAA violations. The Georgia practice paid an $80,000 fine and also agreed to implement a corrective action plan. 

 

The third case concerns Paradise Family Dental, a dental practice located in Las Vegas, Nevada. On behalf of her minor child, a mother requested the child’s PHI from Paradise Family Dental several times between April 11, 2020, and December 4, 2020, but she did not receive any portion of her child’s records. On October 26, 2020, the mother filed a complaint with OCR, in response to Paradise Family Dental’s inaction, detailing the practice’s failure to provide access to the child’s PHI. More than eight months after the initial request, the mother finally received the child’s records on December 31, 2020. OCR determined that the practice failed to timely and adequately provide the mother access to her child’s medical records amounting to a potential HIPAA violation. The practice paid a $25,000 fine and also agreed to implement a corrective action plan. 

 

The trend among these investigations seems to be that once a complaint is filed, providers turn over the requested records. Granted, they will be forced to pay a large fine for the delay. However, OCR seems to be determined to increase compliance with the patient right of access provision and minimize the need for patients to file a complaint with OCR in order to receive their medical records. Hopefully, these investigations got OCR’s message of compliance across, and providers will be more willing to provide patients with timely access to their own information (and to avoid large fines). 

 

 

 Works Cited: 

https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html#:~:text=General%20Right,or%20for%20the%20covered%20entity 

 

https://www.hhs.gov/about/news/2022/09/20/ocr-settles-three-cases-dental-practices-patient-right-access-under-hipaa.html  

Monkeypox Declared a Public Health Emergency

Shane Richards, Class of 2023, Belmont Law

On August 4, 2022, the Biden administration declared Monkeypox a public health emergency, with over 8,900 cases being reported across the United States and many more cases being reported globally. The declaration came on the heels of the World Health Organization declaring Monkeypox a “public health emergency of international concern.” A couple months later, the number of cases has nearly tripled to 26,577 across the United States, as reported by the CDC. That is only the number of cases at the time of writing this blog, as the total continues to increase every day. This puts the United States in a unique, yet worrisome, position of facing two national health emergencies at the same time: COVID-19 and Monkeypox.

Specifically, the Health and Human Services Secretary (“HHS”), Xavier Becerra, made the decisive announcement, being empowered by the Biden administration to “explore very option on the table to combat the monkeypox outbreak and protect communities at risk.”  Pursuant to the Public Health Services Act, this declaration will allow the HHS to pursue available options and to better coordinate a national response. Specifically, § 319 allows the HHS to “take such action as may be appropriate” to combat public health emergencies, opening up new avenues for the administration to fund treatment research and get vaccines to effected areas. This initiative is also working in concert with the FDA’s new strategies for the creation and distribution of vaccines. In fact, the FDA has been able to create and prepare a vaccine much faster than with COVID-19. The declaration of a public health emergency will help to expedite the distribution of these new vaccines to the most effected parts of the country. Further, the declaration will allow the HHS to coordinate a national response through vital data sharing agreements with all fifty-one jurisdictions.

If these measures prove inadequate to deal with the emergency, then it’s possible that the HHS could invoke powers under the Public Readiness and Emergency Preparedness Act to increase access to treatment. The President could also invoke emergencies powers, granted by various acts, to increase production of vital medical equipment and vaccines. However, it is not yet clear whether such declarations will be necessary.

It would seem that the Biden administration, and other federal institutions, have learned several valuable lessons from the COVID-19 epidemic, having allocated more than one million vaccine doses in total and organized a united administrative strategy to directly deal with it. However, despite these measures, these institutions are still failing to fully cut this emergency off at the pass, which is why Monkeypox continues to make headlines. The COVID-19 pandemic revealed that the United States lacked vital infrastructure to deal with such public health emergencies, particularly on at the level of a pandemic. Though some efforts have been made to correct some of those fatal mistakes, the response to Monkeypox has faltered in some key areas. Particularly, funding, information sharing, and the procurement of ample supplies, particularly vaccines, have slackened behind. The above-described declarations are designed to relieve these issues before they get too bad, but time will tell if these measures have been taken in a timely fashion or if certain lessons remain to be learned.

Works Cited:

https://www.hhs.gov/about/news/2022/08/04/biden-harris-administration-bolsters-monkeypox-response-hhs-secretary-becerra-declares-public-health-emergency.html

https://www.verywellhealth.com/monkeypox-rates-by-state-6272347#:~:text=Global%20cases%3A%2070%2C420%201%20U.S.%20cases%3A%2026%2C049%202,monkeypox%20have%20been%20identified%20in%20the%20U.S.%202

https://www.foxnews.com/health/biden-administration-declare-monkeypox-public-health-emergency

https://www.who.int/europe/news/item/23-07-2022-who-director-general-declares-the-ongoing-monkeypox-outbreak-a-public-health-event-of-international-concern

New Precedent: Pharmacy Chains Held to Create a Public Nuisance in Opioid Crisis

Kendall Warden, Class of 2024, Belmont Law

The United States District Court Northeastern District of Ohio, Eastern Division, in a giant MDL encompassing 11 bellwether trials, issued an abatement order on August 17 mandating three giant pharmacy chains to pay a combined $650 million dollars towards the opioid crisis.

 

This specific track three bellwether trial in the Northern District of Ohio decided: “(1) only public nuisance claims (2) against only the pharmacy defendants (3) in their roles as distributors and dispensers.” After receiving briefs on whether the trial should be to a jury or a bench, the Court concluded “that public nuisance liability will be determined by the jury,” and “if liability attaches, the Court will separately fashion remedies.”

 

Plaintiffs in this case, Lake County and Trumbull County, sued defendants alleging their actions “led to a severe oversupply of prescription opioids, which ultimately created a public nuisance.” The original defendants included Rite Aid and Giant Eagle, but both companies settled before Phase I of trial. This left CVS, Walgreens, and Walmart as the remaining defendants proceeding to trial. After a six-week presentation of evidence and one week deliberation, the jury found for Plaintiffs and against all three of the defendants. The jury specifically concluded, “that: (1) oversupply of legal prescription opioids, and diversion of those opioids into the illicit market outside of appropriate medical channels, is a public nuisance in [the Plaintiff counties]; and (2) each of the three defendants (CVS, Walmart, and Walgreens) engaged in intentional and/or illegal conduct which was a substantial factor in producing the public nuisance. The jury clearly affirmed that all three defendants had “caused a significant and ongoing interference with a public right to health or safety that is ongoing today. CVS, Walgreens, and Walmart all filed motions claiming the verdict was not supported by the weight of the evidence and requesting a new trial. The Court denied the motions.

 

In Phase II of the trial, the Court pointed out the depth and extent of the opioid crisis. Specifically, that even if Defendants were found to have created the opioid crisis, there is no possible way they could abate the crisis themselves without additional, and extensive, financial resources. The Court detailed its goal was to provide injunctive relief with the objective not to compensate Plaintiffs for past harm, an award of damages, but instead to offset the costs of abating the nuisance. This is the purpose of an abatement remedy. The scope of an effective abatement remedy in this case includes programs and interventions that will lessen or remove the nuisance condition Defendants created. To no avail, the Court, after providing multiple opportunities to do so voluntarily, ordered the three pharmacy defendants to submit a proposed abatement plan. Frustratingly, “the Defendants did not even attempt to suggest any plausible lesser alternatives,” than Plaintiffs’ expensive, proposed abatement plan.

 

Plaintiffs’ plan requires Defendants to fund programs to decrease OUD and addiction from the Counties’ populations. Specifically, the effective proper scope includes funding programs for (1) “treatment of those suffering from opioid addiction or OUD, including funding of programs to identify and connect with those individuals; and (2) prevention of opioid abuse and opioid recidivism.” Despite Defendants’ objections that the Court was backhandedly awarding damages to Plaintiffs, the Court’s abatement remedy will inevitably cost Defendants money. Approximately a combined amount of $650 million dollars to be precise.

This is the first time pharmacy chains have been on the hook for paying towards the opioid crisis, and it will be interesting to see how wide the door will open now that it has been cracked. Maybe when a court asks you to provide a reasonable plan, you should provide a reasonable plan.

 

https://www.ohnd.uscourts.gov/sites/ohnd/files/4611.pdf

https://www.americanbar.org/groups/health_law/section-news/2022/september/pharmacy-chains-on-the-hook-to-pay-towards-opioid-crisis/

THE FORESEEABLE END OF THE AVAILABILITY OF GOVERNMENT FUNDED COVID-19 VACCINES 

Azariah Bridgewater, Class of 2024, Belmont Law

From the beginning of the COVID-19 pandemic until now, federal funding has fronted the cost for all persons within the United States to receive vaccines and boosters without payment or proof of insurance. The widespread availability of free COVID-19 vaccines may, however, come to a halt in early 2023 since Congress has not made any plans to fund the purchase of additional vaccines. Consequently, pharmaceutical companies, such as Pfizer Inc. and Moderna Inc., have begun taking steps to commercialize the sale of vaccines and vaccine-related products.

The commercialization of COVID-19 vaccines, tests, and treatments means that they will become available through typical healthcare channels. One byproduct of this transition is that pharmaceutical companies are likely to increase vaccine costs. For example, the federal government currently pays approximately $16.50 per dose of the Moderna vaccine. Once the vaccine is commercialized, Moderna’s CEO anticipates a $60 cost associated for each dose. This forty-dollar price increase will inevitably lead to higher healthcare insurance premiums. 

While many healthcare insurance premiums are likely to increase, the uninsured may soon find that they are unable to obtain vaccination or other COVID-19 treatments. Although federal government officials in charge of managing the transition between federally and privately funded vaccine availability do not desire restricted vaccine access for the uninsured, it is currently unclear what options the uninsured will have. What we know now is that Congress intends to lighten the burden of vaccine and treatment costs through cost-sharing, the Centers for Disease Control and Prevention intends to provide vaccines for uninsured adults and children as long as funding lasts, and the Association of Immunization Managers is dedicated to make sure that the vaccine and COVID-19 related resources are available to all who need them. 

 Works Cited 

Fifth Circuit: Christian Medical Groups Cannot Be Punished for Refusing Abortions and Gender Reassignment Surgery

Shane Richards, Class of 2023, Belmont Law

On August 26, 2022, the Fifth Circuit Court of Appeals handed down a ruling holding that the United States Government cannot punish Christian medical providers for refusing to conduct abortions and gender reassignment surgery. The Court held that punishing a Christian hospital for not conducting such operations would deprive such groups of their religious freedom and constitute a “per se irreparable harm.” It is well established that, while an abortion is a constitutional right, the government cannot force a doctor to provide an abortion against their religious beliefs. Further, most states have enacted statutes to protect doctors from civil actions that may result from a refusal to provide an abortion because of sincerely held religious beliefs. This case, however, reinforces another wrinkle in abortion law and drags another hotly debated topic into the spotlight for discussion: gender reassignment surgery.

This long-running case began in May, 2016, and has spent the last six years winding its way through the system, being remanded to the district court twice. The case began with the HHS’s interpretation of Section 1557 of the Affordable Care Act (“ACA”), which prohibited health care programs receiving federal funds from discriminating against patients “on the basis of sex.” In 2016, the HHS interpreted the rule to include discrimination on the basis of “termination of pregnancy” and “gender identity.” Groups of Christian Medical and Dental associations filed suit for a permanent injunction, challenging the validity of the HHS’s interpretation on religious grounds under the First Amendment, RLUIPA, and RFRA. Throughout the litigation and several administrations, the HHS’s issued several rules on its interpretation in light of new and pending litigation. Then, in March, 2022, the HHS issued a “Notice and Guidance on Gender Affirming Care,” holding that the refusal to give gender-reaffirming care, such as gender reassignment surgery, likely violates Section 1557. Questions of mootness arose because of the various alterations and the HHS asserted that it had not decided whether it would actually enforce Section 1557 against Christian medical providers. The Court rejected this argument.

The HHS also argued that the district court erred in granting a permanent injunction based upon the statute rather than just vacating the 2016 Rule, thereby granting relief beyond the scope of the complaint. However, the Court likewise dismissed this argument, holding that a challenge to an agency’s regulation is necessarily a challenge to the underlying statute as well. In short, the Government cannot eliminate one’s standing by altering an agency’s interpretation of the statute.

With those more procedural questions out of the way, the Fifth Circuit then dedicates only a paragraph to the more substantive part of the ruling that has captured some headlines: that the Government cannot punish Christian doctors, by way of withholding otherwise available federal funds and participation in ACA exchanges, for refusing to conduct abortions and gender reassignment surgeries. The portion of the ruling concerning abortion comes as no surprise and is a logical extension of the general rule that the Government cannot force or coerce a doctor from going against his or her sincerely held religious beliefs concerning abortion.

However, the more interesting part of the holding concerns gender reassignment surgery, making an addition to the growing number of federal cases concerning the constitutionality of gender reassignment surgery and gender identity. This case may be a harbinger for things to come as similar tensions between religious freedom and other constitutional rights also characterize gender reassignment surgery. It certainly, at a minimum, places these questions of gender reassignment surgery under consideration next to abortion, giving it a sort of publicity by proxy. This decision comes only three years after the Campbell v. Kallas decision from the Western District Court of Wisconsin, which mandated that a prison inmate be given the opportunity to undergo gender reassignment surgery. The Court held that prior failures to provide that surgery violated the prisoner’s Eight Amendment protections. However, the Campbell decision has been distinguished in other cases before the Seventh Circuit. Likewise, a case out of the Northern District of Indiana held the opposite of the Wisconsin Court in Renee v. Neal, holding that receiving gender reassignment surgery is not a “clearly established federal constitutional right.” This area of law is still burgeoning, but it will be interesting to see where it goes. Judging by its inclusion next to abortion in this case, similar legal contours may emerge to accommodate the widening acceptance of gender reassignment surgery as a necessary operation protected, to some extent, under the Constitution.

Works Cited:

Franciscan All., Inc. v. Becerra, No. 21-11174, 2022 U.S. App. LEXIS 24142 (5th Cir. Aug. 26, 2022).

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Renee v. Neal, 483 F. Supp. 3d 606 (N.D. Ind. 2020).Bottom of Form

https://www.msn.com/en-us/news/opinion/us-government-can-e2-80-99t-force-christian-groups-to-perform-abortions-gender-reassignment-surgery-court-rules/ar-AA11fmen

https://today.westlaw.com/Document/If7a83b9027cd11edaf97fc4e38a46710/View/FullText.html?transitionType=CategoryPageItem&contextData=(sc.Default)&firstPage=true&OWSessionId=NA&skipAnonymous=true&bhcp=1

https://www.reuters.com/article/us-health-abortion-access-idUSKBN1XT2HA