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Articles 1 - 30 of 208

Full-Text Articles in Health Law and Policy

Narrowing In On The Problem: A Component-Level Analysis Of "Hybrid" Medical Devices, Jillian Friedmann Apr 2019

Narrowing In On The Problem: A Component-Level Analysis Of "Hybrid" Medical Devices, Jillian Friedmann

Boston College Law Review

The Medical Device Amendments of 1976 (“MDA”) classify medical devices into three categories, each of which represents a different level of risk, and requires a different level of federal oversight. Class III devices, which pose the most risk, are subject to the highest level of oversight. Those devices are protected from any claims based on state laws that differ from or add to the requirements imposed by the MDA. On March 1, 2018, the United States Court of Appeals for the Third Circuit, in Shuker v. Smith & Nephew, PLC, considered the application of preemption under the MDA to a “hybrid ...


Evaluating The Legality Of Age-Based Criteria In Health Care: From Nondiscrimination And Discretion To Distributive Justice, Govind Persad Mar 2019

Evaluating The Legality Of Age-Based Criteria In Health Care: From Nondiscrimination And Discretion To Distributive Justice, Govind Persad

Boston College Law Review

Recent disputes over whether older people should pay more for health insurance, or receive lower priority for transplantable organs, highlight broader disagreements regarding the legality of using age-based criteria in health care. These debates will likely intensify given the changing age structure of the American population and the turmoil surrounding the financing of American health care. This Article provides a comprehensive examination of the legality and normative desirability of age-based criteria. I defend a distributive justice approach to age-based criteria and contrast it with two prevailing theoretical approaches to age-based criteria, nondiscrimination and discretion. I propose a detailed normative framework ...


Safe Injection Sites And The Federal "Crack House" Statute, Alex Kreit Feb 2019

Safe Injection Sites And The Federal "Crack House" Statute, Alex Kreit

Boston College Law Review

Safe injection sites have become the next battlefield in the conflict between state and federal drug laws. A safe injection site is a place where injection drug users can self-administer drugs in a controlled environment under medical supervision. They have been operating in other countries, including Canada, for decades, and a wealth of evidence suggests that they can help to reduce overdose deaths. To date, however, no United States city or state has sanctioned a safe injection site. Until recently, safe injection sites were politically untenable, seen as a form of surrender in the war on drugs. This dynamic, however ...


Why Healthcare Companies Should Be(Come) Benefit Corporations, Yaniv Heled, Liza Vertinsky, Cass Brewer Jan 2019

Why Healthcare Companies Should Be(Come) Benefit Corporations, Yaniv Heled, Liza Vertinsky, Cass Brewer

Boston College Law Review

Our healthcare system is broken. Despite spending far more on healthcare per capita than any other country, health outcomes in the United States are relatively poor. There is a pervasive disconnect within the healthcare system between private incentives to develop and provide healthcare products and services and public health needs. Mainstream proposals for how to fix the system have focused on changes in regulation, incentive schemes, consumer behavior, and competition in healthcare markets. All of these proposals share the assumption that the development and provision of healthcare products and services will remain primarily in the hands of traditional corporations and ...


A “Natural” Stand Off Between The Food And Drug Administration And The Courts: The Rise In Food-Labeling Litigation & The Need For Regulatory Reform, Amy-Lee Goodman Jan 2019

A “Natural” Stand Off Between The Food And Drug Administration And The Courts: The Rise In Food-Labeling Litigation & The Need For Regulatory Reform, Amy-Lee Goodman

Boston College Law Review

Faced with the health and financial toll from escalating rates of chronic disease, consumers are demanding healthier food products and increased transparency regarding the ingredients in their food. Food labels provide the primary means for businesses to communicate with customers about their food products. In response to consumer demand, food companies are stocking grocery store shelves with products claiming to be wholesome, “natural” and healthy. Yet, many of these products are not as healthy or natural as purported. Although both consumers and food manufacturers place importance on the term “natural,” the Food and Drug Administration has refused to define the ...


Closing The Regulatory Gap For Synthetic Nicotine Products, Patricia J. Zettler, Natalie Hemmerich, Micah L. Berman Jul 2018

Closing The Regulatory Gap For Synthetic Nicotine Products, Patricia J. Zettler, Natalie Hemmerich, Micah L. Berman

Boston College Law Review

In July 2017 the U.S. Food and Drug Administration announced a new “comprehensive plan for tobacco and nicotine regulation.” This plan focuses on making cigarettes less addictive while facilitating the development of alternative, and less-harmful, nicotine-containing products. This approach holds promise, and the public health stakes could not be higher—smoking is the leading cause of preventable death in the United States, resulting in roughly 480,000 deaths per year. But a new consumer product is emerging that could upset the FDA’s plans for a well-balanced regulatory scheme: synthetic nicotine. Synthetic nicotine products currently fall into a regulatory ...


Healthcare Promises For Public Employees, Natalya Shnitser Jul 2018

Healthcare Promises For Public Employees, Natalya Shnitser

Boston College Law School Faculty Papers

State and local governments have promised nearly $1 trillion in retiree healthcare benefits to public employees. Although retiree healthcare benefits represent a form of compensation, historically, state and local governments have not set aside any money to pay for the promised benefits. Compensating employees with promises of future benefits has enabled state legislatures to use public dollars for other priorities, while ignoring the growing liabilities associated with the healthcare promises. As these liabilities have come due, they have strained state and local budgets. Some public employers have simply cut the benefits, and public employees have had limited recourse to hold ...


The Burgeoning “Biorights Movement”: Its Legal Basis, What’S At Stake, And How To Respond, Mark A. Hayden May 2018

The Burgeoning “Biorights Movement”: Its Legal Basis, What’S At Stake, And How To Respond, Mark A. Hayden

Boston College Law Review

The advent of genetic and genomic technologies has the power to transform the understanding, prevention, and treatment of disease on a scale unprecedented in modern medicine. The promise of the era of precision medicine risks being tempered by the emergence of what is increasingly being referred to as the “biorights movement.” Of particular concern is the growing trend of individuals refusing to contribute their biological material to research studies absent some form of monetary compensation. Recently announced, but yet to be implemented, regulations seek to mitigate some of the potentially harmful and progress-impeding positions advanced by the biorights movement. The ...


Correcting Correctional Suicide: Qualified Immunity And The Hurdles To Comprehensive Inmate Suicide Prevention, Venus Chui Apr 2018

Correcting Correctional Suicide: Qualified Immunity And The Hurdles To Comprehensive Inmate Suicide Prevention, Venus Chui

Boston College Law Review

Suicide is the leading cause of death in U.S. jails, and the second leading cause of death in U.S. prisons. Suicidal behavior among inmates largely stems from the custodial environment and inmates’ difficulties coping with incarceration. Unfortunately, many correctional facilities lack the comprehensive suicide prevention policies necessary to reduce inmate suicides. Under the qualified immunity doctrine, current law also shields correctional authorities from liability for failure to implement adequate suicide prevention programs in their facilities. As a result, corrections officials lack incentive to enhance their efforts toward reducing inmate suicides, and families of inmate suicide victims have limited ...


Commodifying Consumer Data In The Era Of The Internet Of Things, Stacy-Ann Elvy Feb 2018

Commodifying Consumer Data In The Era Of The Internet Of Things, Stacy-Ann Elvy

Boston College Law Review

Internet of Things (“IoT”) products generate a wealth of data about consumers that was never before widely and easily accessible to companies. Examples include biometric and health-related data, such as fingerprint patterns, heart rates, and calories burned. This Article explores the connection between the types of data generated by the IoT and the financial frameworks of Article 9 of the Uniform Commercial Code and the Bankruptcy Code. It critiques these regimes, which enable the commodification of consumer data, as well as laws aimed at protecting consumer data, such as the Bankruptcy Abuse Prevention and Consumer Protection Act, various state biometric ...


Pathologizing “Radicalization” And The Erosion Of Patient Privacy Rights, Kelly Morgan Feb 2018

Pathologizing “Radicalization” And The Erosion Of Patient Privacy Rights, Kelly Morgan

Boston College Law Review

Countering Violent Extremism (“CVE”) is a counterterrorism strategy ostensibly aimed at preventing “radicalization” through risk assessment and intervention. CVE involves recruitment of helping professionals, including mental health care providers, to monitor their patients for signs of “vulnerability to radicalization,” make referrals to “de-radicalization” programs, and participate in multidisciplinary intervention teams. Broad national security and public safety exceptions within existing privacy laws allow mental health professionals participating in CVE to make potentially harmful disclosures of private patient information. This Note argues that professional associations representing mental health care providers should develop policies to limit and regulate members’ participation in CVE.


Sin Taxes: Have Governments Gone Too Far In Their Efforts To Monetize Morality?, Franklin Liu Feb 2018

Sin Taxes: Have Governments Gone Too Far In Their Efforts To Monetize Morality?, Franklin Liu

Boston College Law Review

In June 2016, Philadelphia became the largest city in the United States to pass a soda tax, which went into effect on January 1, 2017. Soda taxes, an umbrella term for taxes that are assessed on sugar-sweetened beverages, represent the latest incarnation in a recent wave of non-traditional “sin taxes.” Sin taxes target behaviors that the government considers to be socially undesirable, and traditionally have been levied to curb consumption of alcohol and tobacco products. As state and local governments continue to face burgeoning budget deficits, legislators have increased the amount of existing sin taxes and expanded the sin tax ...


The Price Tag On Designer Babies: Market Share Liability, Boston College Law Review Staff Jan 2018

The Price Tag On Designer Babies: Market Share Liability, Boston College Law Review Staff

Boston College Law Review

The prospect of genetically modifying humans has loomed over the public for decades. Now, science fiction is becoming reality. New technology and expanding research are positioned to make genetic alteration a routine, pre-conception appointment. For several years, China has been experimenting with germline editing on non-viable human embryos. In April 2016, the UK also approved a group of scientists to begin similar research. In the United States, genetic engineering is a multibillion-dollar industry. Although ethical debates over human genetic modification have checked the industry, the potential for clinical trials has become a reality as companies race to dominate the technology ...


Cleaning Up The Standards Of The Mental Hygiene Law: State V. Dennis K. And Civil Commitment, Maria Benvenuto Jun 2017

Cleaning Up The Standards Of The Mental Hygiene Law: State V. Dennis K. And Civil Commitment, Maria Benvenuto

Boston College Journal of Law & Social Justice

On July 5, 2016, in State v. Dennis K., the Court of Appeals of New York upheld the civil commitment of two individuals in accordance with article 10 of the Mental Hygiene Law. The majority relied on the testimony of expert witnesses and the individuals’ past criminal records to classify them as possessing a “mental abnormality” that predisposes them to commit sexual offenses, a necessary element of a civil commitment finding. The court ultimately found the evidence presented sufficient to make this classification and indefinitely restrict the freedom of such individuals. In contrast, the dissent emphasized the lack of certainty ...


Walking On Eggshells In The Workplace: Denying Workers’ Compensation Liability Using The Employee Knowledge Standard In Ramirez-Trujillo V. Quality Egg, L.L.C., Christopher Cataldo Jun 2017

Walking On Eggshells In The Workplace: Denying Workers’ Compensation Liability Using The Employee Knowledge Standard In Ramirez-Trujillo V. Quality Egg, L.L.C., Christopher Cataldo

Boston College Journal of Law & Social Justice

On April 15, 2016, the Iowa Supreme Court held that employers in workers’ compensation cases could deny liability for medical expenses incurred by employees even if they did not give notice to the employee that expenses were no longer authorized. Employers can avoid liability by demonstrating that the employee knew or reasonably should have known that such expenses were no longer authorized at the time the employee incurred them. In reaching this decision, the Iowa Supreme Court reversed two lower court decisions and the workers’ compensation commissioner. Judge Daryl L. Hecht’s dissent argued against the majority’s new “employee ...


Marijuana Legalization And Nosy Neighbor States, Alex Kreit Jun 2017

Marijuana Legalization And Nosy Neighbor States, Alex Kreit

Boston College Law Review

As more states proceed with marijuana legalization laws, questions have arisen about how to accommodate those states that wish to retain prohibition. For instance, in 2014, Oklahoma and Nebraska unsuccessfully sued Colorado based on the spillover effects that Colorado’s marijuana legalization law had on its neighboring states. This article asserts that there are several reasons why state marijuana legalization laws are unlikely to have a large effect on neighboring states. First, marijuana is not a previously unobtainable good being introduced into the stream of commerce, as it is already available through the black market inexpensively. Second, legalization laws have ...


Introduction: Marijuana Laws And Federalism, Erwin Chemerinsky Jun 2017

Introduction: Marijuana Laws And Federalism, Erwin Chemerinsky

Boston College Law Review

No abstract provided.


Budding Conflicts: Marijuana's Impact On Unsettled Questions Of Tribal-State Relations, Katherine J. Florey Jun 2017

Budding Conflicts: Marijuana's Impact On Unsettled Questions Of Tribal-State Relations, Katherine J. Florey

Boston College Law Review

In the wake of a December 2014 decision by the Department of Justice to deprioritize enforcement of federal marijuana laws against tribes as well as states, many tribes have reevaluated their policies toward marijuana. Tribal attitudes toward marijuana are diverse; some tribes regard marijuana as a public health menace, whereas others see it as a source of economic opportunity. Where tribal policies are significantly more or less restrictive than those of the surrounding state, tribal-state relations have often suffered friction. The problem is particularly acute given the jurisdictional uncertainty that characterizes Indian country and the absence of any equivalent to ...


Marijuana, State Extraterritoriality, And Congress, Mark D. Rosen Jun 2017

Marijuana, State Extraterritoriality, And Congress, Mark D. Rosen

Boston College Law Review

The Trump administration inherits the Obama administration’s policy of under-enforcing federal marijuana laws and a nation with a patchwork of divergent state laws. Although allowing diversity and experimentation, such divergence may impose spillover costs to some states. Some states may attempt to address these costs by exercising extraterritorial regulatory powers on their citizens. Although it is unclear and a matter of dispute whether and to what extent states have such extraterritorial authority, this Article shows that it is certain that Congress has power to set the bounds of state extraterritorial regulation, subject to only limited constitutional restraints. The Article ...


Saving On Health Care While Protecting The Planet: An Examination Of Massachusetts’ Proposed Carbon Tax And Its Impact On The Hospital Industry, Alexandra Shalom Jun 2017

Saving On Health Care While Protecting The Planet: An Examination Of Massachusetts’ Proposed Carbon Tax And Its Impact On The Hospital Industry, Alexandra Shalom

Boston College Environmental Affairs Law Review

Climate change has negative implications not only for the environment, but also for human health. Human greenhouse gas (“GHG”) emissions are a major contributor to climate change and therefore we must curb our behavior to save the planet and ourselves. Following the economic principle of the First Law of Demand, a carbon tax incentivizes polluters to reduce emissions by increasing the cost of emission producing goods. British Columbia has demonstrated that carbon taxes are effective mechanisms to curb GHG emissions. Massachusetts, therefore, has proposed a carbon tax to help achieve its established GHG reduction goals. In addition, the Commonwealth’s ...


Deference To The Agency Is The Best Policy: The D.C. Circuit Applies Chevron In Denying Additional Medicare Reimbursements To Provider Hospitals In Washington Regional Medicorp, Brandon Curtin May 2017

Deference To The Agency Is The Best Policy: The D.C. Circuit Applies Chevron In Denying Additional Medicare Reimbursements To Provider Hospitals In Washington Regional Medicorp, Brandon Curtin

Boston College Law Review

On December 29, 2015, in Washington Regional Medicorp v. Burwell, the U.S. Court of Appeals for the District of Columbia Circuit held that the Secretary of Health and Human Services (“HHS”) correctly interpreted the Tax Equity and Fiscal Responsibility Act of 1982 (“TEFRA”) in calculating Medicare reimbursements for a provider hospital based on the capped target amount from the previous year. In agreeing with the Secretary, the D.C. Circuit joined the U.S. Courts of Appeals for the Third and Sixth Circuits in holding that the statute and its implementing regulations supported the Secretary. The U.S. Court ...


The Crisis Inside Crisis Pregnancy Centers: How To Stop These Facilities From Depriving Women Of Their Reproductive Freedom, Brittany A. Campbell Apr 2017

The Crisis Inside Crisis Pregnancy Centers: How To Stop These Facilities From Depriving Women Of Their Reproductive Freedom, Brittany A. Campbell

Boston College Journal of Law & Social Justice

Since the late 1960s, pro-life activists have been flooding the United States with crisis pregnancy centers (CPCs), facilities disguised as legitimate reproductive health clinics but, in reality, are mostly unlicensed centers that do not provide contraception or abortion services. These facilities deprive women of their reproductive freedom when they engage in deceptive practices to coerce women out of terminating their pregnancies. This Note examines recent unsuccessful attempts to curb CPC practices and highlights the destructive impacts of CPCs, particularly on young, low-income, and minority women. Misleading CPC tactics bar women from exercising their constitutional right to command their reproductive decisions ...


Weaponizing Citizen Suits: Second Circuit Revises The Burden Of Proof For Proving Sham Citizen Petitions In Apotex V. Acorda Therapeutics, Franklin Liu Apr 2017

Weaponizing Citizen Suits: Second Circuit Revises The Burden Of Proof For Proving Sham Citizen Petitions In Apotex V. Acorda Therapeutics, Franklin Liu

Boston College Law Review

In 2016, in Apotex Inc. v. Acorda Therapeutics, Inc., the United States Court of Appeals for the Second Circuit held that a generic drug company could not rely solely on the timing of the Food and Drug Administration’s (“FDA’s”) disposition of a citizen suit and approval of a generic application to state a claim under the Sherman Act based on sham litigation. By contrast, in 2009, in In re DDAVP Direct Purchaser Antitrust Litigation, the Second Circuit held that precisely such evidence was sufficient to state a Sherman Act claim. This Comment argues that the Second Circuit’s ...


The Role Of Antitrust Principles In Patent Monopolies: The Third Circuit Applies Antitrust Scrutiny To No-Ag Patent Settlements In Smithkline, Meghan Fay Apr 2017

The Role Of Antitrust Principles In Patent Monopolies: The Third Circuit Applies Antitrust Scrutiny To No-Ag Patent Settlements In Smithkline, Meghan Fay

Boston College Law Review

On June 26, 2015, in King Drug Co. of Florence v. Smithkline Beecham Corp., the U.S. Court of Appeals for the Third Circuit held that no-authorized generic agreements (“no-AG agreements”), in which a pioneer pharmaceutical manufacturer agrees not to introduce a generic drug, are subject to antitrust scrutiny under the Sherman Act. This Comment argues that the Third Circuit correctly extended the U.S. Supreme Court decision in Federal Trade Commission v. Actavis to non-cash settlement agreements. In Actavis, the Court held that a “reverse-payment settlement,” which compensates a generic manufacturer to delay market entry, creates monopolistic consequences and ...


Mercury’S Toxic Process: How Bad Science And Bad Decisions Caused A Public Health Crisis, Cameryn Mercurio Apr 2017

Mercury’S Toxic Process: How Bad Science And Bad Decisions Caused A Public Health Crisis, Cameryn Mercurio

Boston College Environmental Affairs Law Review

Since 1998, ethylmercury, a vaccine preservative, has often been confused with methylmercury, a dangerous neurotoxin, by the government and public. This confusion has led to a decrease in vaccination rates and an increase in the spread of preventable disease. Despite significant efforts to educate the public on the inaccuracy of studies linking ethylmercury to autism, the public health agencies have been unsuccessful in demonstrating to the public that the substance is safe. This Note analyzes the actions taken by the public health agencies responding to public concerns about ethylmercury’s use in vaccines and recommends that the agencies undertake a ...


Microbeads And The Toxics Use Reduction Act: Preventing Pollution At Its Source, Davis Truslow Apr 2017

Microbeads And The Toxics Use Reduction Act: Preventing Pollution At Its Source, Davis Truslow

Boston College Environmental Affairs Law Review

Microbead pollution presents a significant threat to human health and the environment. As a result, Congress enacted a national ban on microbeads in 2015. This ban is a drastic, reactionary measure that fails to address the continued threat posed by already existing pollution. In addition, the ban represents a continued preference for the command-and-control regulatory framework that failed to prevent microbead pollution in the first place. In contrast, pollution prevention, an alternative regulatory technique adopted by Congress as national policy in 1990, more efficiently prevents pollution by focusing on reducing pollution at its source. In 1989, Massachusetts became the first ...


A Narrowing Of Section 1983 Claims: How Gonzaga Has Limited Recovery For Victims Of Lead Poisoning In Federal Court, Anna Snook Apr 2017

A Narrowing Of Section 1983 Claims: How Gonzaga Has Limited Recovery For Victims Of Lead Poisoning In Federal Court, Anna Snook

Boston College Environmental Affairs Law Review

Dellita Johnson brought a claim against the City of Detroit on behalf of her minor son, asserting that her son sustained lead poisoning from the public housing unit in which they lived. She brought claims under 42 U.S.C. § 1983 for the deprivation of federal rights created under provisions of the United States Housing Act, the Lead-Based Paint Poisoning Prevention Act, and administrative regulations created under those statutes. The United States Court of Appeals for the Sixth Circuit affirmed the District Court’s dismissal of Ms. Johnson’s claims, holding that the applicable provisions of the United States Housing ...


Failing Cities And The Red Queen Phenomenon, Samir D. Parikh, Zhaochen He Apr 2017

Failing Cities And The Red Queen Phenomenon, Samir D. Parikh, Zhaochen He

Boston College Law Review

Cities and counties are failing. Unfunded liabilities for retirees’ healthcare benefits aggregate to more than $1 trillion. Pension systems are underfunded by as much as $4.4 trillion. Many local government capital structures ensure rising costs and declining revenues, the precursors to service-delivery insolvency. These governments are experiencing the Red Queen phenomenon. They have tried a dizzying number of remedies, but their dire situation persists unchanged. State legislatures have failed to respond. More specifically, many states have refused to implement meaningful debt restructuring mechanisms for local governments. They argue that giving cities and counties the power to potentially impair bond ...


Guacamole Is Extra But The Norovirus Comes Free: Implementing Paid Sick Days For American Workers, Erin Garrity Apr 2017

Guacamole Is Extra But The Norovirus Comes Free: Implementing Paid Sick Days For American Workers, Erin Garrity

Boston College Law Review

The 1993 Family and Medical Leave Act (“FMLA”) provides eligible workers with twelve weeks of unpaid leave. Because the FMLA excludes most short-term illnesses, workers suffering from the flu or similar illnesses still go to work while sick. This phenomenon, referred to as presenteeism, poses a risk to public health and reduces workplace productivity. Some states and cities have adopted paid sick time laws, but other states have adopted preemption laws prohibiting local paid sick time legislation. The Healthy Families Act (“HFA”), which proposes federally-mandated, employer-provided paid sick days for all employees in businesses of fifteen employees or more, would ...


The Cost Of High Prices: Embedding An Ethic Of Expense Into The Standard Of Care, Isaac D. Buck Jan 2017

The Cost Of High Prices: Embedding An Ethic Of Expense Into The Standard Of Care, Isaac D. Buck

Boston College Law Review

In the midst of rapid and radical change of America’s health care system, the country’s crown jewel public health insurance program, Medicare, faces an intensifying cost crisis due to a past of uncontrolled prices and a future of booming enrollment. A cost challenge garnering particular media attention is pharmaceutical drug pricing for Medicare Part B. Historically, congressional action has hamstrung Medicare’s ability to limit costs, and as a result, the program is increasingly forced to pass on drug costs—through copays and coinsurance—to its elderly beneficiaries. Public outrage has followed recent stories of pharmaceutical companies seeking ...