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Articles 31 - 44 of 44
Full-Text Articles in Law
Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson
Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson
University of Michigan Journal of Law Reform Caveat
Compounding is the act of combining, mixing or altering ingredients to create a drug tailored to the needs of an individual patient, such as a child who needs a less potent dose, an elderly patient who has trouble swallowing, or an individual with a severe allergy to a drug component. Compounding pharmacies, which engage in large-scale drug compounding, have come under the microscope recently because of the ongoing deadly outbreak of fungal meningitis that began in 2012. Fungal meningitis “occurs when the protective membranes covering the brain and spinal cord are infected with a fungus.” The recent outbreak was caused …
Past Its Prime: Why The Clean Air Act Is In Need Of Modification, Levi Smith
Past Its Prime: Why The Clean Air Act Is In Need Of Modification, Levi Smith
University of Michigan Journal of Law Reform Caveat
The Clean Air Act (CAA) is the primary federal statute regulating the emission of air pollutants. First enacted in 1970, the CAA requires, inter alia, the federal government to establish air quality goals and states to develop implementation plans to achieve those goals. The most stringent requirements of the CAA are imposed on “new” or “modified” sources of pollution, such as sulfur dioxide, nitrous oxides, and particulate matter. Sources that were operating when the CAA was enacted are mostly exempt from regulation under the Act. Because of the substantial costs associated with the CAA standards, there is an incentive for …
Is Honor Tangible Property?, James Santiago
Is Honor Tangible Property?, James Santiago
University of Michigan Journal of Law Reform Caveat
United States Marine Corps Sergeant Dakota Meyer said, “When they told me that I would be receiving the Medal of Honor I told them that I didn’t want it, because I don’t feel like a hero.” This statement reflects the feelings of many real war heroes who deserve and are given recognition yet feel that they are unworthy of such accolades. Unfortunately, there are also individuals who want the recognition of being a war hero but lie about having served. Nevertheless, the First Amendment will continue to guarantee the freedom of speech of those who lie about unearned military honors …
Improving Patent Notice And Remedies: A Critique Of The Ftc's 2011 Report, Alan Devlin
Improving Patent Notice And Remedies: A Critique Of The Ftc's 2011 Report, Alan Devlin
Michigan Telecommunications & Technology Law Review
2011 was an eventful year for those interested in patent law. In March, the Federal Trade Commission ("FTC") released a report that urges the Patent and Trademark Office ("PTO") and courts to remedy perceived inadequacies underlying the U.S. patent system. The FTC observes that people of skill in the art routinely encounter difficulty in determining the meaning, and hence exclusive scope, of a patent's claims. Not only does this failure of notice stymie the efficient dispersion of technology throughout the economy, the FTC argues, but the judicial process can aggravate the problem by granting inappropriate remedies in patent-infringement cases. Then, …
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Michigan Telecommunications & Technology Law Review
Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …
Text(Plus-Other-Stuff)Ualism:Textualists' Perplexing Use Of The Attorney General's Manual On The Administrative Procedure Act, K. M. Lewis
Michigan Journal of Environmental & Administrative Law
Textualist judges, such as U.S. Supreme Court Justice Antonin Scalia, are well known for their outspoken, adamant refusal to consult legislative history and its analogues when interpreting ambiguous provisions of statutory terms. Nevertheless, in administrative law cases, textualist judges regularly quote the Attorney General’s Manual on the Administrative Procedure Act, an unenacted Department of Justice document that shares all the characteristics of legislative history that textualists find odious: unreliability, bias, and failure to pass through the bicameralism and presentment processes mandated by the U.S. Constitution. As a result, judges that rely on the Manual in administrative law cases arguably reach …
No Contact Parole Restrictions: Unconstitutional And Counterproductive, Sharon Brett
No Contact Parole Restrictions: Unconstitutional And Counterproductive, Sharon Brett
Michigan Journal of Gender & Law
Although what Jesse Timmendequas did was abhorrent, the legislation enacted in the wake of his crime went far beyond making sure we know the pedophiles or pedophile-murderers living in our neighborhoods. Megan's name now lends itself to a host of state laws requiring the state to notify neighbors when a sex offender moves into the neighborhood. The term "sex offender" is intentionally broad, covering everyone from voyeurs and exhibitionists to rapists and child molesters. Yet, Megan's Laws treat them the same way, ignoring some crucial questions: Are all sex offenders alike? Are they all monsters? In reality, the majority of …
Steps To Alleviating Violence Against Women On Tribal Lands, Anjum Unwala
Steps To Alleviating Violence Against Women On Tribal Lands, Anjum Unwala
University of Michigan Journal of Law Reform Caveat
One in three Native American women has been raped or has experienced an attempted rape. Federal officials also failed to prosecute 75% of the alleged sex crimes against women and children living under tribal authority. The Senate bill to reauthorize the 1994 Violence Against Women Act (VAWA) could provide appropriate recourse for Native American women who are victims of sexual assault. This bill (S. 1925), introduced in 2011, would grant tribal courts the ability to prosecute non-Indians who have sexually assaulted their Native American spouses and domestic partners. Congress has quickly reauthorized the Violence Against Women Act twice before. But …
Re-Thinking Health Insurance, Hans Biebl
Re-Thinking Health Insurance, Hans Biebl
University of Michigan Journal of Law Reform Caveat
In May 2009, while promoting the legislation that would become the Patient Protection and Affordable Care Act (PPACA), President Obama said that rising health care costs threatened the balance sheets of both the federal government and private enterprise. He noted that any increase in health care spending consumes funds that “companies could be using to innovate and to grow, making it harder for them to compete around the world.” Despite the rancorous debate that surrounded this health care legislation and which culminated with the Supreme Court’s decision in National Federation of Independent Businesses, the PPACA was not a radical piece …
Clarification Needed: Fixing The Jurisdiction And Venue Clarification Act, William Baude
Clarification Needed: Fixing The Jurisdiction And Venue Clarification Act, William Baude
Michigan Law Review First Impressions
One hates to seem ungrateful. Judges and scholars frequently call for Congress to fix problems in the law of jurisdiction and procedure, and Congress doesn't usually intervene. In that light, the Jurisdiction and Venue Clarification Act ("JVCA"),[1] signed into law on December 7, 2011, ought to be a welcome improvement. And hopefully, on balance, it will be. But in at least one area that it attempts to clarify, the JVCA leaves much to be desired. Professor Arthur Hellman has called the JVCA "the most far-reaching package of revisions to the Judicial Code since the Judicial Improvements Act of 1990."[2] The …
A Very Quiet Revolution: A Primer On Securities Crowdfunding And Title Iii Of The Jobs Act, Thaya Brook Knight, Huiwen Leo, Adrian A. Ohmer
A Very Quiet Revolution: A Primer On Securities Crowdfunding And Title Iii Of The Jobs Act, Thaya Brook Knight, Huiwen Leo, Adrian A. Ohmer
Michigan Business & Entrepreneurial Law Review
This essay introduces the complex regulatory regime that governs the public sale of all securities, no matter how small the offeror. It is intended as a rudimentary roadmap for the start-up or its counsel and will, hopefully, help to illuminate the traps for the unwary while providing an overview of the regulatory universe in which securities crowdfunding will operate.
Deruglatory Riders Redux, Thomas O, Mcgarity
Deruglatory Riders Redux, Thomas O, Mcgarity
Michigan Journal of Environmental & Administrative Law
Soon after the 2010 elections placed the Republican Party in control of the House of Representatives, the House took up a number of deregulatory bills. Recognizing that deregulatory legislation had little chance of passing the Senate, which remained under the control of the Democratic Party, or of being signed by President Obama, the House leadership reprised a strategy adopted by the Republican leaders during the 104th Congress in the 1990s. The deregulatory provisions were attached as riders to much-needed legislation in an attempt to force the Senate and the President to accept the deregulatory riders to avoid the adverse consequences …
Is A Substantive, Non-Positivist United States Environmental Law Possible?, Dan Tarlock
Is A Substantive, Non-Positivist United States Environmental Law Possible?, Dan Tarlock
Michigan Journal of Environmental & Administrative Law
U.S. environmental law is almost exclusively positive and procedural. The foundation is the pollution control and biodiversity conservation statutes enacted primarily between 1969–1980 and judicial decisions interpreting them. This law has created detailed processes for making decisions but has produced few substantive constraints on private and public decisions which impair the environment. Several substantive candidates have been proposed, such as the common law, a constitutional right to a healthy environment, the public trust, and the extension of rights to fauna and flora. However, these candidates have not produced the hoped for substantive law. Many argue that a substantive U.S. environmental …
A Functional Approach To Risks And Uncertainties Under Nepa , Todd S. Aagaard
A Functional Approach To Risks And Uncertainties Under Nepa , Todd S. Aagaard
Michigan Journal of Environmental & Administrative Law
The National Environmental Policy Act (NEPA) mandates that federal agencies evaluate the environmental impacts of their proposed actions. This requires agencies to make ex ante predictions about environmental consequences that often involve a significant degree of factual risk or uncertainty. Considerable controversy exists regarding how agencies should address such risks and uncertainties. Current NEPA law adopts a largely ad hoc approach that lacks coherence and analytical rigor. Some environmentalists and legal scholars have called for a greater emphasis on worst-case analysis in environmental planning, especially after the recent Deepwater Horizon oil spill in the Gulf of Mexico and the meltdowns …