Public Health and Law Notes
Public Health and Law Notes PubH 6335
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This 50 page Bundle was uploaded by Elizabeth Kapelan on Thursday September 1, 2016. The Bundle belongs to PubH 6335 at George Washington University taught by Dr. Perry Payne in Fall 2016. Since its upload, it has received 11 views. For similar materials see Public Health and Law in Public Health at George Washington University.
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Date Created: 09/01/16
Midterm Instructions This exam must be emailed to your Live Session instructor on the date and time specified by your Live Session instructor. Late exams will be downgraded as explained in the syllabus. This is an openbook, takehome exam that must be taken alone. No drafts of the answers should be shared, and you may not provide or receive assistance to/from others. Your exam responses must be written independently without any type of assistance from any other individual(s). Your answers should reflect solely your own work product. Any violation of these rules will result in a failing grade. Answers should be typed, doublespaced, and in 12point Times New Roman font with 1inch margins. Answers not received in this fashion will not be read. There is a maximum 14 (fourteen)page limit (double spaced) on your answers (combined, not for each answer); material beyond the limit will not be considered. Please number your pages. The purpose of this exam is to see if you can focus on certain major legal issues in public health law, identify relevant cases/laws/principles, and clearly, concisely, and effectively present your analyses. Except where specifically noted otherwise, for each question you should generally identify the relevant legal issues involved and discuss how a court would analyze each issue, supporting your answer with relevant facts and cases/laws/principles. There is no need for full case names and/or citations, as long as we can determine to what you are referring. Footnotes and endnotes are permissible, but not necessary; all citations will count toward the page limit. You can assume we know the basic facts of each case in the Gostin textbooks and class power points, and the facts included in each exam question—you do not need to restate full facts except to use them as necessary in your analysis of each question. There may be times when you feel you don’t have all the facts necessary to apply a particular legal rule or to determine how a court would decide an issue. In these instances you are free to make reasonable assumptions based on the facts provided, but you must state what those assumptions are, and when appropriate, you should discuss what would happen if your assumptions apply, and what would happen if they do not. **The exam covers material from class sessions 15 during the Spring 2016 semester. The exam will be scored out of 35 points. The maximum number of points attainable for each question is provided next to the question numbers below. Exam Question # 1 (11 points) 1 (a) The U.S. Constitution offers no express language specifically authorizing Congress to legislate in the realm in public health. However, we know that Congress often does just that. How? Please provide relevant case examples and any applicable rules/tests that may apply. (b) Generally speaking, when reviewing cases involving the infringement of constitutional rights, courts typically use some variation of one of three different standards of review (levels of scrutiny) to determine the constitutionality of the infringement. 1) What are the three levels of scrutiny? 2) Using cases or specific examples to support your answer, please describe under what circumstances a court would apply each of the three levels of scrutiny. Exam Question #2 (12 points) 1) Concerned with the increasing numbers of car accidents among its elderly drivers, the state of Miller (a fictional U.S. state for purposes of this exam) has passed legislation to help ensure that its drivers maintain the skills necessary to drive safely on its roads. Under its new law, drivers over the age of 75 must do the following three things every year: Take and pass a road test to ensure competence and adequate reactionary skills in driving Pass an eye examination to ensure drivers maintain adequate eyesight and/or are wearing the necessary prescription eyewear Take and pass a medical examination, performed by the driver’s own doctor, to ensure adequate health for driving. The medical exam must include a urine test which will, among other things, check for the presence of opioid drugs. Results of the medical examination and urine test will be sent to the state Department of Motor Vehicles (DMV) for review. Drivers must pass all three of these requirements in order to renew their license, including confirmation that the driver’s opioid test is negative. There are no repercussions for failing any one of these requirements other than the denial of their license renewal. However, drivers who test positive for high levels of opioids will receive a pamphlet informing the driver about the dangers of opioid addiction and suggesting that the patient consult his/her healthcare provider to discuss alternative options for managing pain. The pamphlet also provides the number for an “opiate addiction hotline,” which the state established last year after experiencing record numbers of deaths related to opiate overdose. John Taylor is an 80 year old resident in the State of Miller, and an active driver. He drives to the grocery store and the drug store just about every day, and he likes to drive his grandchildren to the park. He has been in a few accidents during his lifetime, but nothing that a few stitches and a collision repair shop couldn’t fix. Admittedly, his eyesight is getting worse, and sometimes he feels tired after taking his medications – he’s on 10 different pills though so he 2 doesn’t know which ones are causing his drowsiness. Luckily for John, he loves coffee and makes sure he has a few cups every day to keep him alert. Last week, John went to the DMV to take his road test and eye exam. To his relief, he passed both with flying colors! The DMV representative told him that once it received his medical report and opioid test results, he would be notified about the renewal decision. Today in the mail, John received a letter from the DMV informing him that his license was not being renewed, along with the opioid pamphlet described above. Unfortunately for John, his urine test was positive for opioids, and his medical report confirmed that he has been taking prescription opioids for chronic back pain for several months, which could impair his driving abilities due to their ability to cause severe sedation and drowsiness. John is furious about losing his license. He thinks it’s unfair that only elderly drivers are subject to these new rules, feels like he’s losing his freedom to drive as he wishes, and feels like the government overstepped its bounds by requiring an opioid test and medical screening. He asks you, a local lawyer specializing in public health law, if there is any way to challenge the new law. What will you tell him? Please discuss, identifying any relevant issues, rules, and how a court might decide each issue. Exam Question # 3 (12 points) A) Under the Affordable Care Act, chain restaurants with 20 or more locations are required to provide on their menus and/or menu boards the number of calories for each standard menu item and a succinct statement describing generally the number of calories that should be consumed by an individual each day. As of March 2010 when Congress passed the ACA, Caty’s Candy Bar had only one store in the U.S., located in New York City. However, thanks to the recent endorsement of Caty’s Candy Bar by a famous talk show host and the nation’s growing infatuation with novelty candy, the owners of Caty’s Candy Bar plan to expand to a whopping 25 locations within the next several months. In addition to a variety of selfserve candy bins, Caty’s offers specialty candy treats, like FunDipandchocolatecovered popcorn, that can only be “madetoorder” from the Caty’s Candy Bar menu. FDA has recently issued revised regulations to implement the labeling law and has expanded its definition of “chain restaurants” to include “any food service establishment with 20 or more locations that offers customers a menu from which to order food.” Caty’s is concerned that based on this new requirement, it will be required to comply with the menulabeling regulations once it has opened 20 locations. The owners are afraid that these regulations will hurt their business and discourage people to buy their candy, which is deliciously high in calories and sugar. The owners believe that the law is unfair and have asked you, a local public health lawyer, to advise them whether there might be any grounds to challenge the law. Discuss. 3 B) Seeing the success of the its menu labeling laws, Congress wants to take things further and ban the roadside billboard advertising of all chain restaurants subject to the ACA menu labeling regulations on all major interstate highways. Congress believes that the lack of billboards will keep more people from exiting the highways to seek out fast food restaurants. Caty’s Candy Bar is dismayed to hear about this new advertising ban, as it hoped to attract traveling customers to its new locations with flashy billboard signs. On what grounds might Caty’s challenge the billboard advertising law? 4 Exam Question #1: (1) Through many interpretations of Congress’s enumerated powers, the Supreme Court of the United States (SCOTUS) has given the federal government an enormous public health presence in various scopes, all pertaining to the health and well being of the public. Even as the th 10 Amendment reserves police power to the states, the state police powers can be preempted to federal laws that are within federal constitutional powers such as ratifying treaties, taxing and spending, and regulating interstate commerce. An example of the spending power enacted by the federal government comes from South Dakota v Dole. South Dakota had a set drinking age of 19, and the Court upheld a federal law that froze 5% of highway funds from the states whose drinking ages are below the federal guideline of 21. An example of interstate commerce comes from Gonzales v Raich, where the court upheld that Congress had authority to prohibit the local cultivation and use of marijuana, despite California state law to the contrary. (2) Strict Scrutiny occurs if a law or government act discriminates against a class of individuals (religion, race, or national origin) or if it threatens a fundamental right (free speech or right to marry). The government must show that the law serves a compelling state interest and that the regulation is tailored to serve the population. An example of this deals with privacy interests of individuals and anything concerning the Bill of Rights. In Intermediate Scrutiny, the government must show that its law is substantially related to an important government interest. Intermediate Scrutiny isn’t often used, but has been used in cases similar to mandatory syphilis testing in females, but not required in males. Finally, for laws that do not implicate either a fundamental right, or a suspect classification, the law must be shown that it is rationally related to a legitimate government interest. An example of a rationally based review is City of Cleburne 5 v Cleburne Living Center, in which the city was denied a special use permit to create a group home for the mentally disabled. Exam Question #2: Mr. Taylor has three main avenues in challenging the new law set forth in the State of Miller. Here, the State of Miller has asked individuals over the age of 75 only, to pass three new laws in order to keep their driver’s license. Mr. Taylor first argues that it is unfair that only elderly drivers are subject to these new rules. In order for a state entity to enforce these rules, the state th has to show it is acting within its police powers. The 10 Amendment states, “the powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” These regulations are constitutionally permissible if it passes a Four Part Test. First, the regulation is necessary to prevent an avoidable harm. They have a real or substantial relation to the protection of public health. Secondly, the burden imposed is not disproportionate to the expected benefit. Next, they do not pose an undue health risk to the subject of the regulation. The fact pattern has pointed out to the government that car accident has increased among its elderly drivers across the entire state. It is to assume, that these increases have been found in all areas of the state, not in just one particular city or region. It will likely be found that the government does have a legitimate interest in the area of increased car accidents among elderly, by passing each part of the Four Part Test. In relation to the requirement that the law must be rationally related or compelling to the state, the court will likely find in favor of the government due to a direct link between increased car accidents and the elderly population, citing these rules will ensure competence and adequate reactionary skills, adequate eye sight in order to see their surroundings, and ensure adequate health for driving. By 6 passing the Four Part Test, the court recognizes the police power of the state. The first instance of applicable police power enforced by the state is Jacobson v Massachusetts which set the foundation for public health law. SCOTUS found it was necessary to vaccinate the entire population, stating it would benefit the entirety; it was found the best means necessary to protect a population from infectious diseases, and most importantly, it benefited the whole population. The Fourteenth Amendment reads, in part, that no state shall “deprive any person of life, liberty, or property, without due process of law.” This applies to both the states and to local governments enforcing the law. Substantive due process holds that government actors have to sufficiently justify the deprivation of life, liberty, or property. An argument for this case would be the State is acting within its police power to require these rules to be passed, in order to protect the entire population. However, the government has compromised Mr. Taylor’s way of living, as well as how he gets around to see his friends and family, which raises issues with the substantive due process clause. The court will have to decide whether this right is a fundamental right or not, which corresponds with different standards to be applied for addressing the case moving forward. If the determination is this is a fundamental right, the court will then apply a strict scrutiny, where the government must show their law is necessary to achieve a compelling government interest and is narrowly tailored. However, if found not a fundamental right, the rational basis review is then applicable, where the law must be rationally related to a legitimate government interest. Looking at the United States Constitution and other related decisions, a number of substances have been subject to strict regulation without constitutional challenge, leading to this right being found not a fundamental right and subject to a rational review. Benning v State displays how the court 7 applies the rational basis test where there is no constitutional right based on one’s liberty interest, which is to be left alone by the government’s helmet rules. th The 14 Amendment further protects from government action that discriminates among different people or groups. The Equal Protection Clause provides that no state shall deny to any person within its jurisdiction “the equal protection of the laws”. This new law clearly points out the elderly, aged 75 and higher, and requires them to pass three laws in order to be able to drive. In order to even have this claim, we must show the government’s purpose was to discriminate against the elderly. In Jew Ho v Williamson, the court decided against a law that was facially neutral, that discriminated against members of the Chinese race and had no actual health benefit. This new law explicitly points out the elderly population, however this case differs from Jew Ho because it will likely result in a positive health outcome, decreasing the rate of car accidents. The State might be found discriminating the elderly population, especially coinciding with the last rule of an opioid drug test. It is rational to assume a large amount of people take these types of medication for chronic pain in America, not just individuals aged 75 or older. However, if an equal protection clause claim can be made, a rational basis review will be raised, due to the claim of discrimination of age. Similar basis to the substantive due process clause analysis, the court will likely uphold the law under an equal protection challenge. Exam Question #3: The issue with this case is the disclosure of calories for each menu item for chain restaurants with 20 or more locations, specifically whether or not it violates Caty’s Candy Bar’s right to freedom of speech under the 1 Amendment. Compelled commercial speech in the 8 respect to this case, courts are likely to allow the government to compel truthful, nondeceptive, and accurate information and will carefully scrutinize political or ideological speech. New York State Restaurant Assn. v NYC Board of Health gives us a standard of review in our case. It is known the potential health risks of high caloric consumption, and the FDA is now taking clear measures to disclose the number of calories by chain restaurants around the nation. New York State Restaurant Assn. applied a rational connection test in upholding a NYC law requiring chain restaurants to post nutritional information about foods on their menus. Disclosure information is treated differently from restrictions on commercial speech because it mandated disclosure of accurate, factual information which does not offend the core First Amendment values of promoting information exchange and protecting individual liberty interests. Less demanding scrutiny is required than where truthful, nonmisleading commercial speech is restricted. In our case, the FDA requires the disclosure of this truthful, nonmisleading information, and will likely be upheld if the court applies this review process, as it is rationally related to caloric intake. Central Hudson will not be used in this case, since it only applies to truthful disclosures, and not endorsement of a certain viewpoint, or other issues that raise further commercial speech concerns. Question #3 Part B: th The 10 Amendment reserves police powers to the states, however, the states power may be preempted by adopted federal laws according to its federal constitutional authority. Here, we look at suppressed commercial speech and whether the new law violates Caty’s Candy Bar’s right to freedom of speech under the 1 Amendment. The Central Hudson test has been developed by SCOTUS, which is a fourpart test for the government regulation of commercial 9 speech. Central Hudson requires (1) that the speech must concern a lawful activity and not be false, deceptive, or misleading; (2) the government interest asserted must be substantial, (3) the regulation must directly and materially advance governmental interest asserted, and (4) the regulation must be no more extensive than necessary to serve government’s interest. The advertisement passes as not an unlawful activity, and the government does have substantial interest in high caloric consumption among people who eat at chain restaurants, thus the first two parts of Central Hudson pass. The government needs to show that speech injunction will keep more people from exiting the highways to seek out fast food restaurants, which they will most likely have a hard time doing so. In 44 Liquormart Inc. v Rhode Island, the Court decided against a regulation banning all price advertisements of alcohol beverages, except in stores, because the state failed to show that the speech exclusion would significantly reduce the marketwide consumption, which failed the last two parts of Central Hudson. In the case Lorillard Tobacco v Reilly, the court found that outside advertisement failed the fourth part of Central Hudson, because regulations were more extensive than necessary to meet the government’s interest. The regulation on our current case of banning roadside billboard advertising seems to have more extensive than necessary effect; all restaurants should have the equal opportunity to advertise on billboards, and shouldn’t be limited because they are a chain restaurant. The government will likely not be able to prove that the regulation directly and materially advances the government’s interest, and the regulation does appear to be more extensive than necessary, which will likely fail Central Hudson part 3 and 4. 10 11 Exam Question #1: Mr. Green’s Lung Cancer: Tort Claim The first legal option the Green family can pursue is through tort litigation with respect to Mr. Green’s lung cancer. The grounds for the suit are in respect to E&B’s negligence through the emission of harmful pollutants that may have caused his lung cancer. Duty and Breach Industrial businesses are anticipated to emit a degree of environmental pollutants but are restricted to emit quantities under state and federal law. However, there is little uncertainty that businesses have a duty to the public to keep theses emissions from having damaging effects and are a nuisance to others. Determining a level of breach by E&B in this case will depend on a number of variables and will require extensive investigation. Minimally, two standards will have to be determined, 1) a measurable amount of air pollutants emitted by the factory, and 2) if emissions violated any state or federal pollution regulation. If the standards are met by E&B, it will be difficult to prove negligence in emitting unreasonable levels of pollutants. Causation Causation will be the most difficult element to distinguish in this case. Even though the E&B factory is known for thick black smoke coming from their chimneys, we have to recognize the state of Madison is known as a “factory state” and the smallest state in the country. Singling out E&B, where there is a substantial amount of other factories that could be emitting even more harmful pollutants, will be found difficult to convince a jury. Air pollutants will be hard to distinguish given several amounts of them, and eventually all our likely to blend into one another making it impossible to establish causation and foundation of each lung cancer case. Mr. Green will have a hard time establishing causation for his lung cancer in a claim against E&B, however he has likely been affected by emissions of E&B along with emissions of the many factories in the city and state. Conjoining the main contributors to the air pollution and seeking a class action suit may be worth while for Mr. Green and his family. Damages Mr. Green could ask for monetary damages for medical expenses, pain and suffering, mental distress, and lost wages, however he will most likely not succeed at doing so. Seeking injunctive relief could also be done by Mr. Green. Assumption of Risk The defendant could raise an assumption of risk defense, stating the Green family and every other resident in the state knows the risk of living in the state. Even though Madison is known as an industry state, this would most likely be an unsuccessful defense. Billy Green’s Illness: Product Liability Claim It does appear Billy’s illness is related to the red paint on the E&B ‘Bronco’ toy truck. A thorough investigation into the painting of the trucks found that E&B factories were using a relatively cheap paint, that contained several toxic chemicals including lead. The Green Family could pursue a defect claim because the use of an alternative paint could have reduced the risk of exposure to lead and other toxic chemicals. A design defect claim outdoes a manufacturing defect claim because the toy used that specific paint and was manufactured as intended for sale. In this scenario, a negligence tort claim could be contemplated. Causation In order to have a successful causation claim for Billy Green, we must show Billy’s illness is directly linked to E&B’s Bronco. The details states that Billy has “fallen ill inexplicably,” and we do need further information regarding the illness in order to establish causation. The Green family should bring Billy to a physician who will determine whether or not the illness was caused by cheap paint on the Bronco toy. If he shows symptoms that are consistent with lead health effects, such as poisoning, and the red paint’s other toxic chemicals, we may have a convincing claim. Damages The severity of illness will affect the recovery for damages in this case. If the illness was acute and minimal, then pursuing damages may not be worth it. If the illness had caused chronic effects with significant consequences, monetary damages should be pursued. Quantification of damages becomes more difficult in this situation. Punitive damages should be sought first and foremost, because E&B’s knowingly use of banned substances in the product production phase. Conversely, if E&B was unaware of its use of banned substances, claims against the supplies of raw material should be considered by the Green family. It is most likely not possible for injunctive relief since E&B has already voluntarily removed the Bronco from the market. In this case again, a class action suit should be considered. Private Nuisance Not related to any of the Green’s family medical problems, a private nuisance claim could be a way of recovering damages or injunctive relief from E&B. The local air pollution constitutes an unreasonable and substantial intrusion with the satisfaction of their residential property. As discussed previously, it will be difficult to prove the factory is a direct cause of the interference with the satisfaction of their property since other businesses are contributing to the local air pollution as well. More information on E&B’s pollutant emissions is deemed necessary in order to determine the excessiveness of their actions. Scientific Evidence Scientific evidence and expert testimony may be needed in order to verify this case against E&B. There are large amounts of unknowns and need for evidence discovery pertaining to the case, unfortunately, with high costs coming from both of these scenarios, the Green family may not be willing to make these investments alone. Exam Question #2: The Health Insurance Portability and Accountability Act, simply known as HIPPA governs the legal protections of private, protected personal health information. Under certain circumstances, the federal law can permit the unauthorized disclosure of HIV serostatus even without Adam’s authorization. This occurs for use primarily in research, public health, and public interest operations. Many states often require to report diseases in the likes of HIV and general communicable diseases to both state and federal agencies. State’s Department of Health will specify their specific reporting requirements. Unauthorized disclosures are permitted in order to advance health and safety interests by conducting epidemiology, surveillance, monitoring, and investigations. When assuming that the state required the reporting of Adam’s HIV infection, it likely disclosed very little personal individually identifiable information to the state/federal health agency. Information reported to the government is well protected and will likely never be disclosed to a private party, even spouses. In the instance Adam is mostly concerned with his wife becoming aware of his HIV status partner notification and the physician’s duty to warn will be discussed. States impose a duty on health care providers requiring them to warn third parties of foreseeable physical harm or infection, while other states hold a “may warn” policy. In Tarasoff v Regents of the University of California (1976), the Supreme Court of California held that mental health professionals have a duty to protect individuals who are being threatened with bodily harm by a patient. A physician has a duty to warn if, 1) it is a foreseeable 2) a serious risk of injury or death 3) there is an identifiable victim/contact. Following this ruling, a court will likely find that there is a duty of the physician to inform Adam’s spouse of his HIV status. Adam stated that he intends to hide the information from his wife, fearing that she will leave him. Looking further into the state’s status and case law will help us understand the state’s duty to warn standard of procedure. Adam showed also be advised on his duty to inform and potential liabilities associated with infecting his wife after failing to inform her of his know HIVpositive status. Exam Question #3: The Fourth Amendment forms the right of the people from unreasonable searches or inspections by the government. Probable cause creates the basis for obtaining a warrant for a reasonable search or inspection, however, when dealing with public health issues, the probably cause standard is lowered and it is easier for the government to obtain access to businesses for public health reasons. Due to various complaints, the Summerville Health Department decided to inspect the daycare unannounced and without a search warrant. Per rule, warrants for health and safety inspections are always required, detailing the search and the objective of the search. There are exceptions to this rule granted 1) when there is legally valid consent from an authorized person, 2) an emergency to deviate immediate threat to health or safety, 3) searching areas open to the public, i.e., plain view, 4) “closely regulated businesses” (Burger test). Exception #1 is not applicable since the Jacksons never consented to the search. Exception #3 does not apply because a portion of the search involved the back storage room, not a public area. The City could argue it was justified in conducting a warrantless search because of certain circumstances such as “an emergency to deviate immediate threat to health or safety,” which is exception #2. This is a considerably weak argument being chief complaints were in relation to sounds, odors, and rodents, none of which gives rise to an emergency. These issues do not pose a serious and immediate health risk to the community. The City’s actions could be justified if this was a closely regulated business. The Burger test outlines the criteria for inspections of “closely regulated businesses” 1) a substantial government interest for the regulatory scheme under which the warrantless inspection is conducted 2) the warrantless inspection must be necessary to further the regulatory scheme 3) the inspection must be regular and certain under the regulatory scheme such that the owner “cannot help but be aware” that the property will be subject to inspection. Burger #1 will likely be found by the court as “substantial government interest” in which the warrantless inspection was conducted. The City does have a substantial interest in protecting the public health and safety after receiving the complaints. A court will also likely find that Burger #3 was met since this is a permitted and regulated business where owners should have known the government was going to inspect the business. An issue lies in Burger #2, where the City could have a hard time proving that the warrantless inspection was necessary to furthering the regulatory scheme. It is unlikely that the Jacksons would have been able to take temporary corrective measures before a warrant was issued. Unlike Players Inc., where the social club could easily and quickly cease and hide all signs of smoking, the daycare could not mask and conceal its strong pet and chemical odors and rodent issues in a short amount of time. Furthermore, the Jacksons were surprised about the inspection, deeming they likely would have not taken any corrective measures in the time that the City would have needed to get a warrant. This holds that the warrantless inspection was likely not necessary to furthering the regulatory scheme. These details support the claim that the search did not satisfy the Burger Test, and did not meet any of the lawful exceptions for a warrantless search. The City also passed a new law, given its police powers, forbidding the operation of animalrelated businesses in designated areas. It applies to both existing and future businesses, which intends to serve the interests of both residential homes and community recreation areas. The court will likely apply a rational basis level of scrutiny to this new law, and determine whether the nuisance abatement was reasonably necessary to divert a health threat, even if it interferes with private property rights. Our argument directs that the nuisance abatement directly interferes with the Jackson’s private property and economic rights. They made huge financial investments in purchasing the property and in renovating the building one year after obtaining the necessary permits. The city granted the permits and knew the purpose of running a daycare business. We do not believe the nuisance abatement was reasonably necessary to avert a health threat. All Health Department findings were quickly and permanently remedied within several weeks of the inspection, with no reason to believe the problem will return. A concern for the health of the City’s residents does not amount to an existing health threat. Since there are no known issues with other local animalrelated businesses, there is no public benefit that could reasonably justify depriving the Jackson’s rights to use their property how they deem fit. The court will most likely see fit that a nuisance abatement is not related to any existing health threat, and the City took unnecessary actions that significantly affect the Jacksons’ business. Even though the City did not physically seize the property, the new law did deprive the Jacksons’ enjoyment and economic benefit of the property that was being used as a daycare business. This establishes a regulatory taking of the property, and the Fifth Amendment states just compensation for such takings. There are two types of regulatory takings, “per se” and “non per se” and the courts apply different rules for both. A “per se” categorical taking occurs when the regulation deprives the owner of all economic, beneficial use or productive use of a property. In Lucas v South Carolina Coastal Counsel, the plaintiff purchased beachfront property wanting to build two single family homes. A new state law barred Lucas from building the homes two years later. The court rules the regulation was for the benefit of the community, and that the landowners should not have to anticipate that the government may eliminate all worth of the land without just compensation. Lucas case also focused on the reasonable expectations of the buyer at the time the property was purchased. We could argue that the regulatory taking is fairly similar to the categorical taking in Lucas. The intention made by the Jacksons was for use as an animalrelated business, which is evident when spending $200,000 on renovating the building for that purpose. Due to the new regulation, the Jacksons should not expect to recover their total investments. The property value will likely have reduced in value since renovation took place for a business purpose that is restricted, and it should be reasonable to assume that the Jacksons will have difficulties in attempting to sell the property as is. Similar to Lucas, the novel law clearly eliminated all economically viable use of the land. The City could possibly argue that the property did not experience a complete loss of property value as a result of the new law. The Penn Central test would apply if the court finds in favor of the City, however, the arguments are weak and will likely not stand. Under the Penn Central Test, the courts would have to consider three factors, 1) the economic impact of the regulation on the property owner, 2) the extent to which the regulation has interfered with investmentbacked expectation, 3) the character of the government action. Nonetheless, we do have a strong argument detailing just compensation according to a per se regulatory taking. Exam Question #4a The United States is responsible for a national International Health Regulation (IHR) focal point that communicates with the World Health Organization (WHO). The Watch Center at Health and Human Services (HHS) serves as the US’s national IHR focal point which meets minimum requirements to detect, assess, report, and respond to public health events at the local, intermediate, and national levels. The US must also be able to support detection and control around its ports and border; however, the lettuce product has already been distributed throughout the US and to six other countries. It will be of great difficulty for the US to cease all exports of lettuce or much less identify which lettuce shipments are contaminated. Any action taken by the US must be evidencebased and must take into consideration impacts on trade and travel. Being aware of an outbreak on a national level, the US must develop a framework for notifying the WHO within hours of a potential PHEIC. Annex 2 provides a framework that assists nations in determining whether an emerging disease must be reported to the WHO. With 68 hospitalizations and 5 deaths, we can consider the effects of the E.coli outbreak as serious, and since it falls under an unusual or unexpected event, decision algorithm in Annex 2 suggests that there is a duty to inform. Even if the US decided there was no duty to inform, there should be err on the side of caution and report the incident. There are no formal enforcement mechanisms or sanctions within the WHO for breaking the IHR. The WHO can affect travel and trade, but it is doubtful that this would be attempted since the United States is the largest financial contributor to the WHO. Exam Question #4b The focus of the old IHR were only on diseases such as cholera, yellow fever, and plague. Subsequently, many countries did not adhere to the IHR, because it did not reflect the changing public health issues that face the world in present time. Due to this limitation, the US would likely not have had a duty to report the outbreak to the WHO, and consequently face little to no repercussions or sanctions. Extra Credit Question Congress passed the “Raw is Risky Act,” which gave the FDA authority to develop regulations to ensure that all raw milk sold in the US is safe for human consumption. We must address the issue of whether Congress appropriately delegated authority to the FDA. Congress has only granted express authority for the FDA to develop regulations to ensure the safe consumption of raw milk, by doing so, Congress still has its policymaking functions. It is only granting regulationforming authority to the FDA because of its specialization and expertise. If Congress would have given the authority to the FDA to have implemented the nationwide ban in the sale of raw milk, severe nondelegation issues could have arisen, however, since the FDA has delegated regulatory functions, there is likely no issue. Finding that Congress likely did not err in delegating authority to the FDA under the RRA, we can now consider whether or not the FDA acted within its scope of delegated authority. Applying the Chevron deference test is how we can further determine whether the agency operated within its scope. We find that Chevron Step #1/Chevron Exception #2 are applicable. In FDA v B&W Tobacco Corp., the Supreme Court of the United States found that it was “clear that Congress intended to exclude tobacco products from the FDA’s jurisdiction” when considering the Food, Drug, and Cosmetic Act (FDCA) as an entire entity. Congress has directly spoken to the issue of raw milk sales, and has granted the FDA authority to regulate the safety of “all raw milk that is sold in the US.” The intent of Congress clearly states allowing raw milk to be sold in the US, and if Congress did not intend for any raw milk to be sold, then it would not have delegated authority to the FDA for regulating purposes. According to Chevron Step #1/ Chevron Exception #2, Congress has directly spoken to an issue, an agency cannot form a different judgment and a court will not give deference to the agency’s contradictory actions. Another issue concerning Chevron Step #2 could arise if the court does not find Congress has spoken directly to the issue. The FDA’s actions, although based on prior experience and knowledge, did not consult any outside experts or other public health officials, leaving an argument the FDA may have acted arbitrarily or capriciously. Federal and state agencies must follow specific rules when issuing regulations. The FDA “quickly” drafted a new rule and made no mention of FDA having taken necessary steps under the rulemaking processes. With any type of rulemaking procedure, the agency must provide notice, and the agency must allow for interested persons to submit written comments. After comments are given, the agency is required to give consideration to the public comments it appears that the FDA did not follow this set procedure, subsequently the court will likely find that the rule is unenforceable. Public Health and Civil Liberties III: Public Health Countermeasures for Epidemic Disease: Introduction Isolation • The separation of persons who have a specific infectious illness from those who are healthy and the restriction of their movement to stop the spread of that illness Quarantine • The separation and restriction of movement of persons who, while not yet ill, have been exposed to an infectious agent and therefore may become infectious *Criminal Element to them Federal Quarantine Laws • Cholera • Diphtheria • Plague • Infectious tuberculosis • Smallpox • Yellow fever • Viral hemorrhagic fevers • SARS • Influenza (swine, bird flu) Overview: Public Health Strategies for Epidemic Disease • Isolation and quarantine • How legal system addresses epidemics while dealing with basic rights of association, travel, and liberty 1 Individual liberty vs. community health 2 Deeply rooted in constitutional rights Isolation and Quarantine • Isolation: 1 Separation of persons who have a specific infectious illness from those who are healthy 2 Restriction of movement to stop spread of illness 3 Jail, medical isolation • Quarantine: 1 Separation and restriction of movement of persons not yet ill but who have been exposed to infectious agent 2 Home (shelter in place), institutional (school, dorm, hotel), work, travel, geographic Federal Quarantine Authority • Power derived from Commerce Clause 1 Public Health Service Act §§ 361–368 (enabling act) 2 42 Code of Federal Regulation (CFR) Parts 70 and 71 (CDC regulations for interstate and foreign arrivals quarantine) • Power vested in HHS Secretary (through CDC): "Make and enforce regulations as are necessary to prevent the introduction, transmission or spread of communicable diseases from foreign countries into the US or from one State or possession into another." PHSA § 361 *Designed to keep disease from entering country and spreading * No regulations to keep disease from leaving country visàvis isolation and quarantine Enforcement of Federal Authority • FBI, HHS, and other federal agents: 1 Authority to apprehend, detain, examine, and conditionally release people • Detention without commission of crime. • Feds can accept state help in enforcing quarantine order. 1 States rarely decline federal request for help. • Feds can assist states upon request. 1 Feds can't enter state under own volition. • Feds in charge of interstate situations. • States in charge of intrastate situations. • Local, state, and federal officials can exercise quarantine powers concurrently. • Largescale federal quarantine authority not used since 1918–1919 Spanish flu epidemic. 1 Hundred of people lost freedom of movement Executive Order 13295: Revised List of Quarantinable Communicable Diseases • Cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever • Viral hemorrhagic fevers 1 Lassa, Marburg, Ebola, Crimean Congo, South American 2 Others not yet isolated or named • SARS (added in 2003) 1 "(c) Influenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause, a pandemic." CDC: Do Not Board List • Intended to prevent spread of disease via air travel. • Doesn't authorize use of isolation and quarantine. • Applies only to commercial airplanes. • Violation of quarantine order can result in maximum fine of $1,000 or one year in prison. • To be included on the list: ▯ Person is likely contagious with a communicable disease that would constitute a serious public health threat should the person be permitted to board a flight. ▯ Is unaware of or likely to be nonadherent with public health recommendations, including treatment. Likely will attempt to board a commercial aircraft. 1. Likely is contagious with a communicable disease that would constitute a serious public health threat should the person be permitted to board a flight. 2. Is unaware of or likely to be nonadherent with public health recommendations, including treatment. 3. Likely will attempt to board a commercial aircraft. 4. Airlines instructed not to issue boarding passes to those on list. 5. Foreigners' home countries are notified of inclusion on list. State Quarantine Authority • Majority of quarantine power rests with local and state authorities. • Part of police powers. • Municipal and state quarantine laws have existed since colonial era. • Quarantine must apply to specific diseases. • Definitions can be broad to allow leeway. State Codes • Virginia 1 The State Health Commissioner shall have the authority to require quarantine, isolation, immunization, decontamination, or treatment of any individual or group of individuals when he determines any such measure to be necessary to control the spread of any disease of public health importance... • Washington Each health officer is hereby directed to use every available means to ascertain the existence of, and immediately to investigate, all reported or suspected cases of tuberculosis in their infectious stages within his or her jurisdiction and to ascertain the sources of such infections. In carrying out such investigations, each health officer is invested with full powers of inspection, examination, treatment, and quarantine or isolation of all persons known to be infected with tuberculosis that is in an infectious stage... Issues of Constitutionality for Isolation and Quarantine • Rights of individual • Impact on personal autonomy • Impact on economy 1 Effect on business and travel • Discrimination 1 Infected persons blamed for their condition 2 Quarantine as punishment Risk of government abusing power to target groups of people Irish targeted based on false link between drinking and cholera. Constitutional Requirements for Isolation and Quarantine • Due process: Fifth (federal) and 14th (state) Amendments 1 No person shall "be deprived of life, liberty, or property, without due process of law..." 1 Equal protection under the law Jew Ho v. Williamson, 1900 • San Francisco Board of Health adopted resolution quarantining 12 blocks in Chinatown after outbreak of bubonic plague. • Residents sued, claiming regulation was enforced only against Chinese. • Courts agreed with residents. 1 Disease wasn't confined to one neighborhood or one people. 2 "...with an evil eye and an unequal hand." Procedural Due Process Concerns • Length of confinement • Access to a lawyer • Right to be heard • Right to work • Right to medical treatment 1 Not guaranteed but usually granted Answers come from case law, not language of written law Greene v. Edwards, 1980 • Plaintiff involuntarily confined in hospital pursuant to West Virginia TB Control Act. • Claimed confinement was unconstitutional. 1 Lack of timely access to legal counsel violated due process. • Mathews balancing test used to determine procedural due process. 1 Deprivation of liberty 2 Risk of erroneous decision 3 Burden of additional procedures Greene v. Edwards used to establish new set of common law principles: • Adequate written notice • Right to counsel • Right to be present, crossexamine, confront, and present witnesses • Clear and convincing standard of proof • Right to transcript of hearing(s) Judgment: Greene's lack of access to counsel violated Fifth Amendment. Pre–Civil Rights Era • Subject must be infectious. • Safe and habitable conditions must be provided. Confinement must be fair and just. Further Constitutional Considerations • Freedom of movement fundamental right. • Fundamental rights require strict scrutiny. 1 Compelling interest 2 Narrowly tailored 3 Substantial threat • Court cases build on common law. • Containment of disease often trumps procedural rights at time of isolation/quarantine. In Re Washington Case, 2007 • Ruby Washington jailed for failing to comply with TB therapy. • Court found her to be health risk because she kept leaving hospital. • Washington sued state for jailing her. • No lessrestrictive alternative. 1 Jail is permissible for persons with TB who fail to comply with treatment. Judgment: Washington must remain in jail. Isolation and Quarantine in Modern Era • State must have compelling interest that is substantially furthered by detention. 1 Only persons with significant risk of transmission may be detained. • Welltargeted intervention. 1 Mass confinement of people in geographic area raises constitutional questions. 2 Can't assume everyone in area is sick. • Leastrestrictive alternative. 1 Courts must require state to demonstrate that there are no alternatives that are less restrictive. • Procedural due process. 1 (Greene v. Edwards) 2 Five elements of common law Unit 5: PH and Civil Liberties II: Medical Countermeasures for Epi Diease Intro: Medical Countermeasures for Epidemic Disease • Three major types: ◦ Vaccinations to prevent getting disease ◦ Screening to identify those who have disease ◦ Treatment to prevent those who have disease from spreading it to keep epi disease spreading further or getting worse but is it legal? what action can the gov’t take, when should they act, when they shouldn’t act? Compulsory Vaccination • Constitutional arguments: ◦ Free exercise/establishment clause ◦ Equal protection ◦ "Liberty"related arguments, which do not prevail over police power (parental rights, education) Results of Compulsory Vaccinations • Decrease/eradication of diseases such as smallpox, polio, measles. • 2001–2010: declines in cases, hospitalizations, deaths, and health care costs associated with vaccinepreventable diseases. • New vaccines were introduced, bringing the number of diseases targeted by U.S. immunization policy to 17. Results of Compulsory Vaccinations (contd) • Vaccination prevents 42,000 deaths and 20 million cases of disease. • Net savings of $14 billion in direct costs and $69 billion in total societal costs Compulsory Vaccination Overview • Compulsory: Issues arise when a law forces vaccination. • Personal autonomy vs. public health. • How one can avoid compulsory vaccinations • Most common among schoolage children and at birth. • Constitutional issues: ◦ Equal protection ◦ Liberty and parental rights ◦ Free exercise and establishment of religion Considered one of greatest PH achievements in 20 century. Small pox, polio, and measles Compulsory Vaccination in School • Seven to 12yearolds recommended to receive DTaP boosters, meningococcal and HPV vaccines, and additional boosters. • All 50 states have school immunization laws. Vaccination (shot itself) vs. immunization (entire process). • Advisory Committee on Immunization Practices makes recommendations, but states make ultimate decision. • According to Gostin, mandates for vaccines are necessary when diseases: ◦ Are highly contagious Cause significant morbidity or mortality
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