Open Access. Powered by Scholars. Published by Universities.®
- Discipline
-
- Food and Drug Law (142)
- Criminal Law (105)
- Health Law and Policy (79)
- Intellectual Property Law (69)
- Constitutional Law (45)
-
- Legislation (43)
- Criminal Procedure (42)
- Entertainment, Arts, and Sports Law (32)
- Administrative Law (30)
- Social and Behavioral Sciences (30)
- Courts (25)
- Law Enforcement and Corrections (24)
- Science and Technology Law (24)
- Antitrust and Trade Regulation (23)
- Law and Society (23)
- State and Local Government Law (23)
- International Law (22)
- Medical Jurisprudence (22)
- Fourth Amendment (20)
- Medicine and Health Sciences (20)
- Law and Gender (19)
- Civil Rights and Discrimination (18)
- Torts (18)
- Supreme Court of the United States (17)
- Law and Race (16)
- Consumer Protection Law (12)
- Evidence (12)
- International Trade Law (12)
- Litigation (12)
- Institution
-
- University of Michigan Law School (117)
- Marquette University Law School (31)
- Touro University Jacob D. Fuchsberg Law Center (25)
- Fordham Law School (19)
- Selected Works (15)
-
- Boston University School of Law (12)
- Villanova University Charles Widger School of Law (11)
- Nova Southeastern University (10)
- American University Washington College of Law (8)
- Duke Law (8)
- Georgia State University College of Law (8)
- Saint Louis University School of Law (8)
- University of Kentucky (8)
- University of Richmond (8)
- Cleveland State University (7)
- SelectedWorks (7)
- University of Maryland Francis King Carey School of Law (7)
- University of Missouri School of Law (7)
- Pepperdine University (6)
- University of Pennsylvania Carey Law School (6)
- BLR (5)
- Cornell University Law School (5)
- University of Miami Law School (5)
- Vanderbilt University Law School (5)
- New York Law School (4)
- Pace University (4)
- University of Colorado Law School (4)
- University of Denver (4)
- University of Missouri-Kansas City School of Law (4)
- University of South Carolina (4)
- Publication Year
- Publication
-
- Michigan Telecommunications & Technology Law Review (28)
- Faculty Scholarship (25)
- Touro Law Review (24)
- Articles (23)
- Marquette Sports Law Review (23)
-
- Michigan Law Review (19)
- University of Michigan Journal of Law Reform (16)
- Fordham Law Review (11)
- Villanova Law Review (11)
- Faculty Publications (9)
- Michigan Journal of International Law (9)
- Nova Law Review (9)
- All Faculty Scholarship (8)
- Georgia State University Law Review (7)
- Law Faculty Scholarly Articles (7)
- Pepperdine Law Review (6)
- ExpressO (5)
- Marquette Elder's Advisor (5)
- Michigan Journal of Gender & Law (5)
- Scholarly Works (5)
- University of Maryland Law Journal of Race, Religion, Gender and Class (5)
- University of Richmond Law Review (5)
- Articles in Law Reviews & Other Academic Journals (4)
- Faculty Works (4)
- Fordham Urban Law Journal (4)
- South Carolina Law Review (4)
- Aaron Edlin (3)
- American University Law Review (3)
- Articles & Chapters (3)
- Case Western Reserve Journal of International Law (3)
- Publication Type
- File Type
Articles 31 - 60 of 467
Full-Text Articles in Law
Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina
Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina
Scholarship@WashULaw
State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on …
Pricing Drugs Fairly, Govind C. Persad
Pricing Drugs Fairly, Govind C. Persad
Sturm College of Law: Faculty Scholarship
Dissatisfaction with drug prices has prompted a flurry of recent legislation and academic research. But while pharmaceutical policy often regards fair pricing as a goal, the concept of fairness itself frequently goes undefined. Legal scholarship—even work ostensibly focused on fairness—has not defined and defended an account of fair pricing. Recent legislative proposals passed by the House and proposed by Sens. Ron Wyden and Chuck Grassley have similarly avoided a determinate position on fairness. This Article explains and defends an account of what makes a price for a drug fair that identifies fair price with social value, argues for implementing fair …
Does Bitcoin Use Affect Crime Rates?, Kevin Keane
Does Bitcoin Use Affect Crime Rates?, Kevin Keane
The Corinthian
Bitcoin is the most widely used cryptocurrency in the world because of its decentralized network that completes user-to-user transactions, eliminating the need for intermediaries. During 2017, the volume of Bitcoin transactions totaled $94.3 trillion. Bitcoin transactions are recorded in a public database called the blockchain. Although the blockchain can keep track of how many transactions there are, it can’t identify the people involved in transactions. The lack of identity increases the anonymity of Bitcoin transactions, making it less detectable when used for crime. Using the Uniform Crime Reporting’s state-level crime rate data and blockchain’s Bitcoin transaction information, I estimate the …
Legal Cooperation Of Cis Countries In The Fight Against Illegal Traffic Drug, Djamaliddin Musaev
Legal Cooperation Of Cis Countries In The Fight Against Illegal Traffic Drug, Djamaliddin Musaev
Review of law sciences
This article examines the international legal cooperation of the member states of the Commonwealth of Independent States in the fight against drug trafficking. The article analyzes the work to create effective regional international legal mechanisms to combat the illegal distribution of drugs, among which the interaction of states in the framework of the Commonwealth of Independent States occupies a special place. The experience of bilateral and regional cooperation of states in the fight against drug trafficking, analysis of the legal basis of cooperation in states within the framework of the Commonwealth of Independent States was studied. The author focuses on …
Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley
Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley
Articles
As Americans report ever-growing difficulty affording their prescription drugs, President Donald Trump has come under increasing pressure to act. To date, the Trump administration has attempted to advance a number of policy initiatives by means of executive action, but it has not yet adopted a program that would meaningfully assist patients. Most recently, the administration proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada, with the intent of reducing spending on drugs by U.S. patients and states and increasing access for patients.
Drug Courts And The Following Of The Federal Guidelines, Charles James Souza
Drug Courts And The Following Of The Federal Guidelines, Charles James Souza
Master’s Theses and Projects
During the 1980’s, drug offense were running high within the United States. The court system along with the police and other fields were forced to form other methods of dealing with offenders who have a substance abuse problem. In 1989, the first drug court in the United States was formed in the state if Florida. The idea was to create a therapeutic method to help those who are committing non-violent criminal acts due to their addiction. The goal of drug court was to get offenders the treatment they needed so they would not resort to criminal activity. Drug court personal …
The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman
The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman
Michigan Law Review Online
In late 2019 and early 2020, a new strain of coronavirus, a family of pathogens causing serious respiratory illness, began infecting populations across the globe. A quick uptick in COVID-19, the disease caused by the novel pathogen, prompted the World Health Organization to declare the outbreak a Public Health Emergency of International Concern on January 30, 2020. By mid-February 2020, with 26 countries reporting cases of COVID-19 infection, the global case count had surpassed 50,000, and had resulted in over 1,500 deaths. The World Health Organization elevated the status of the outbreak to a pandemic in mid-March. As of early …
Intersectionality In The Opioid Crisis: Anti-Black Racism And White, Pregnant, Opioid Users, Craig Konnoth
Intersectionality In The Opioid Crisis: Anti-Black Racism And White, Pregnant, Opioid Users, Craig Konnoth
Publications
No abstract provided.
Congress Should Decline Ill-Advised Legislative Proposals Aimed At Evergreening Of Pharmaceutical Patent Protection, Christopher M. Holman
Congress Should Decline Ill-Advised Legislative Proposals Aimed At Evergreening Of Pharmaceutical Patent Protection, Christopher M. Holman
Faculty Works
There is a widespread perception that drug prices in the U.S. are much higher than they should be, and that the problem is only getting worse. Critics argue that the pharmaceutical industry is improperly gaming the system in a manner that takes advantage of legal loopholes and administrative limitations to the detriment of patients and third-party payers. Both houses of Congress responded in 2019 with a slew of hearings focused on pharmaceutical pricing, and dozens of bills have been introduced that would attempt to bring down the cost of drugs. Much of the discussion, and some of the proposed legislation, …
Urge To Reform Life Without Parole So Nonviolent Addict Offenders Never Serve Lifetime Behind Bars, Johanna Poremba
Urge To Reform Life Without Parole So Nonviolent Addict Offenders Never Serve Lifetime Behind Bars, Johanna Poremba
Touro Law Review
No abstract provided.
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
All Faculty Scholarship
Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …
'Of Sound Mind And Body': A Call For Universal Drug Screening For All Newborns, Frank Vandervort, Vincent J. Palusci
'Of Sound Mind And Body': A Call For Universal Drug Screening For All Newborns, Frank Vandervort, Vincent J. Palusci
Book Chapters
Substance abuse is a major medical and social problem. Estimates suggest that each year some 15 percent of the 4 million babies born in the United States are exposed to drugs or alcohol. Research demonstrates that exposure to these substances is harmful to the children in both the short term and across their developmental trajectory. This chapter summarizes the harms that might result from such prenatal exposure and considers the ways that both federal and state law respond to this. The chapter argues for universal drug testing of newborns in an effort to ascertain whether they have been prenatally exposed …
Prenatal Drug Exposure As Aggravated Circumstances, Frank E. Vandervort
Prenatal Drug Exposure As Aggravated Circumstances, Frank E. Vandervort
Articles
In Michigan, "a child has a legal right to begin life with sound mind and body." Yet the family court may not assert Juvenile Code jurisdiction until after birth. In re Baby X addressed the question of whether a parent's prenatal conduct may form the basis for jurisdiction upon birth. It held that a mother's drug use during pregnancy is neglect, allowing the court to assert jurisdiction immediately upon the child's birth. In deciding Baby X, the Court specifically reserved the question of whether parental drug use during pregnancy might be sufficient to permanently deprive a parent of custody. …
Response To 'Reverse Al Capone-Ism' And The Tax Treatment Of Marijuana Businesses, Douglas A. Kahn, Howard J. Bromberg
Response To 'Reverse Al Capone-Ism' And The Tax Treatment Of Marijuana Businesses, Douglas A. Kahn, Howard J. Bromberg
Other Publications
Mr. Silverberg’s comment stresses that the proponents of the legalization of marijuana have not been able to convince Congress to legalize it, and so it is appropriate for Congress to penalize trafficking in that drug. Apparently, he sees our contention that the penalty adopted in I.R.C. § 280E is irrational and contravenes established punitive jurisprudence as a backdoor attempt to accomplish indirectly, by weakening the penalties on the marijuana businesses, what has not been able to be accomplished by those seeking its federal legalization. That was not the motive for our proposal and is not a fair reading of our …
Response To Dude, Where's My Deduction?, Douglas A. Kahn, Howard J. Bromberg
Response To Dude, Where's My Deduction?, Douglas A. Kahn, Howard J. Bromberg
Other Publications
Mr. Pullin’s thesis is that marijuana should be excluded from § 280E when it is operated legally under state law. However, his preferred solution is that the federal government remove marijuana from Schedules I and II of the Controlled Substances Act of 1970 (CSA), thereby legalizing it for federal law purposes. Either action would exclude the marijuana business from § 280E.
A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho
A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho
Indiana Law Journal
Is more information always better? First Amendment commercial speech jurisprudence takes this as a given. However, when information is only available from a self-interested and marketing-savvy pharmaceutical company, more information may simply lead to more misinformation. Notably, doctors are also misled. This can result in public health harms when companies are promoting unapproved uses of prescription drugs that the Food and Drug Administration (FDA) has approved for other purposes—commonly referred to as “off-label” uses. Contrary to judicial presumptions, as well as the presumptions of some doctors and scholars, doctors are not sophisticated enough to always discern what is true versus …
The Patent On-Sale Bar Post-Helsinn And Its Effect On The Pharmaceutical Industry, Raja Chatterjee
The Patent On-Sale Bar Post-Helsinn And Its Effect On The Pharmaceutical Industry, Raja Chatterjee
Chicago-Kent Journal of Intellectual Property
The purpose of the patent on-sale bar is to discourage inventors from misusing the patent system and unfairly extending their patent exclusivity period. In Helsinn Healthcare v. Teva Pharmaceuticals, the Federal Circuit has distorted this doctrine far beyond its purpose. By including non-public business transactions within the scope of the on-sale bar, the Federal Circuit’s decision contradicts legislative history and express statutory language from the America Invents Act (“AIA”). This interpretation also makes the U.S. the only major patent system where a non-public sale can lead to the forfeiture of an inventor’s patent rights. The inclusion of non-public agreements within …
Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle
Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle
Articles in Law Reviews & Other Academic Journals
Legal scholars are becoming increasingly interested in how the literature on implicit bias helps explain illegal discrimination. However, these scholars have not yet mined all of the insights that science on the social brain can offer antidiscrimination law. That science, which researchers refer to as social neuroscience, involves a broadly interdisciplinary approach anchored in experimental natural science methodologies. Social neuroscience shows that the brain tends to evaluate others by distinguishing between "us" versus "them" on the basis of often insignificant characteristics, such as how people dress, sing, joke, or otherwise behave. Subtle behavioral markers signal social identity and group membership, …
The Convergence Of The War On Terror And The War On Drugs: A Counter-Narcoterrorism Approach As A Policy Response, Lindsay Burton
The Convergence Of The War On Terror And The War On Drugs: A Counter-Narcoterrorism Approach As A Policy Response, Lindsay Burton
CMC Senior Theses
This thesis investigates how and why U.S. policies and agencies are ill-equipped to respond to narco-terrorism and offers some policy recommendations for remedying that. Narco-terrorism is the merging of terrorism and drug trafficking. Terrorist organizations and narcotics traffickers each have much to offer the other; there is potential for symbiosis in the form of cooperation and even hybridization. Examination of the dynamics between terrorist organizations and drug traffickers, combined with an evaluation of the US responses to narcoterrorism in Colombia and Afghanistan, makes it clear that current US policy responses fail to recognize narcoterrorism as a unique challenge, and instead …
A Higher Authority: Canada’S Cannabis Legalization In The Context Of International Law, Antonia Eliason, Robert Howse
A Higher Authority: Canada’S Cannabis Legalization In The Context Of International Law, Antonia Eliason, Robert Howse
Michigan Journal of International Law
Part I of this Article provides an overview of some of the key terms and provisions of Canada’s Cannabis Act. Part II looks at the Cannabis Act in the context of the International Drug Conventions, examining how the various convention provisions might apply, looking first at the Single Convention and then at the 1988 Convention and how that convention fits with Canadian constitutional provisions. Part III focuses on the international human rights framework and how the Cannabis Act might be viewed as compatible with international human rights law even where incompatible with the International Drug Conventions. This Part also offers …
Reefer Madness: The Constitutional Consequence Of The Federal Government's Inconsistent Marijuana Policy, Zachary Ford
Reefer Madness: The Constitutional Consequence Of The Federal Government's Inconsistent Marijuana Policy, Zachary Ford
Texas A&M Law Review
In the past twenty years, the United States has witnessed over half of its states create marijuana laws that expressly contradict the federal government’s complete ban of the drug. Nine states have completely legalized marijuana for recreational use in the past five years alone. Meanwhile, much of the country remains staunchly opposed to legalization in any form. This difference between state and federal law has the largest negative impact on noncitizens, namely lawful permanent residents whom reside in states that follow the federal government’s complete ban. Congress’s Immigration and Nationality Act broadly defines “conviction,” so even minor drug convictions under …
El Chapo Trial Shows Why A Wall Won't Stop Drugs From Crossing The Us-Mexico Border, Luis Gomez Romero
El Chapo Trial Shows Why A Wall Won't Stop Drugs From Crossing The Us-Mexico Border, Luis Gomez Romero
Faculty of Law, Humanities and the Arts - Papers (Archive)
With its tales of bloody violence, corruption, international trade and entrepreneurial innovation, Guzmán's trial offers a telenovela-style explainer on Mexican cartels and their American clients.
The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan
The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan
Faculty Publications
This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …
Gilead Sciences Sued For Failing To Bring A Follow-On Version Of Truvada To Market Sooner., Christopher M. Holman
Gilead Sciences Sued For Failing To Bring A Follow-On Version Of Truvada To Market Sooner., Christopher M. Holman
Faculty Works
In 2012, the United States Food and Drug Administration (FDA) approved Truvada as the first drug for use in the prevention of HIV infection in healthy people who are at high risk of acquiring HIV through sexual activity. Developed and marketed by Gilead Sciences, Inc., Truvada is a fixed-dose combination of two antiretroviral compounds, tenofovir disoproxil fumarate (TDF) and emtricitabine. The World Health Organization (WHO) has identified both TDF and the combination of TDF and emtricitabine found in Truvada as “essential medicines.” In 2015, Gilead began marketing products containing tenofovir alafenamide fumarate (TAF) as a safer and more effective alternative …
Congress Considering Legislation Aimed At Increasing Competition In Pharmaceuticals, Christopher M. Holman
Congress Considering Legislation Aimed At Increasing Competition In Pharmaceuticals, Christopher M. Holman
Faculty Works
The U.S. Congress is currently considering a large number of bills that would attempt to bring down drug prices by a variety or means, including some aimed at reform of certain patent-related aspects of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This Article begins with a brief overview some key provisions of Hatch-Waxman and the BPCIA that have been targeted by these legislative initiatives. It then turns to a discussion of some specific bills currently being considered by Congress that would seek to promote greater competition in the market for pharmaceuticals by amendments …
Drugs' Other Side Effects, Craig J. Konnoth
Drugs' Other Side Effects, Craig J. Konnoth
Publications
Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …
The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, Eugene Mccarthy
The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, Eugene Mccarthy
Michigan Business & Entrepreneurial Law Review
In this Article, I argue that drug companies have created a highly profitable but dangerous business model by employing the same legal tactics as the nineteenth-century “robber barons,” the group of financiers who orchestrated corporate law’s infamous race to the bottom. Like these historical financiers, drug company executives have captured the legal apparatus and regulatory bodies that oversee them. In so doing, they have transformed the law from a system of governance into a set of enabling doctrines. The pharmaceutical industry has turned legislation intended to protect the public into a legal justification for marketing ineffective and unsafe prescription drugs. …
Paper Promises For Drug Innovation, Erika Lietzan
Paper Promises For Drug Innovation, Erika Lietzan
Faculty Publications
Innovation does not stop when a new medicine is launched. Development of new uses for already approved drugs, in particular, can make profound contributions to the public health. Whether a new use is suspected during the initial premarket trials, identified through focused research after approval, or discovered serendipitously by physicians treating patients, however, it requires extensive clinical testing before it can be approved by FDA. This testing takes time and money — three to five years on average, and as much as $300 million. This Article considers the incentives that federal law offers to companies to make this investment: patent …
Judicious Imprisonment, Gregory Jay Hall
Judicious Imprisonment, Gregory Jay Hall
All Faculty Scholarship
Starting August 21, 2018, Americans incarcerated across the United States have been striking back — non-violently. Inmates with jobs are protesting slave-like wages through worker strikes and sit-ins. Inmates also call for an end to racial disparities and an increase in rehabilitation programs. Even more surprisingly, many inmates have begun hunger strikes. Inmates are protesting the numerous ills of prisons: overcrowding, inadequate health care, abysmal mental health care contributing to inmate suicide, violence, disenfranchisement of inmates, and more. While recent reforms have slightly decreased mass incarceration, the current White House administration could likely reverse this trend. President Donald Trump’s and …
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Articles
Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.