Open Access. Powered by Scholars. Published by Universities.®
- Keyword
-
- Health Law and Policy (10)
- Civil Rights and Discrimination (2)
- Labor and Employment Law (2)
- Amalgam risks (1)
- American Dental Association (1)
-
- American Society of Dental Surgeons (1)
- Dental filling (1)
- Dental industry (1)
- Dental treatment options (1)
- ERISA preemption (1)
- FDA regulations (1)
- Food and Drug Law (1)
- HMO liability (1)
- Health care reform (1)
- Informed consent (1)
- Informed decision-making (1)
- Malpractice litigation (1)
- Mercury amalgam fillings (1)
- Patient rights (1)
- Patient safety (1)
- Professional discipline (1)
- Safety risks of dental mercury (1)
Articles 1 - 16 of 16
Full-Text Articles in Law
Fda Regulation Of Adult Stem Cell Therapies As Used In Sports Medicine, Mary Ann Chirba, Berkly Sweetapple, Charles P. Hannon, John A. Anderson
Fda Regulation Of Adult Stem Cell Therapies As Used In Sports Medicine, Mary Ann Chirba, Berkly Sweetapple, Charles P. Hannon, John A. Anderson
Mary Ann Chirba
In sports medicine, adult stem cells are the subject of great interest. Several uses of stem cells are under investigation including cartilage repair, meniscal regeneration, anterior cruciate ligament reconstruction, and tendinopathy. Extensive clinical and basic science research is warranted as stem cell therapies become increasingly common in clinical practice. In the United States, the Food and Drug Administration (FDA) is responsible for regulating the use of stem cells through its “Human Cells, Tissues, and Cellular and Tissue-Based Products” regulations. This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented …
The Aca’S Tobacco Use Rating: Implementation, Inconsistencies And Ironies, Mary Ann Chirba, Alice Noble
The Aca’S Tobacco Use Rating: Implementation, Inconsistencies And Ironies, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
As the Affordable Care Act continues toward full implementation, the law’s complexity is on full display. As we have noted in earlier writings, the ACA continues the federal tradition of using a fragmented approach to allocating oversight responsibilities among federal and state regulators, while maintaining the role of private actors in health care insurance and delivery systems. The result is a dizzying array of plan types (self-insured, fully insured, small market, individual market, large market, grandfathered) subject to an equally dizzying blend of ACA, ERISA, and individual state requirements.
Erisa Preemption Of State “Play Or Pay” Mandates: How Ppaca Clouds An Already Confusing Picture, Mary Ann Chirba
Erisa Preemption Of State “Play Or Pay” Mandates: How Ppaca Clouds An Already Confusing Picture, Mary Ann Chirba
Mary Ann Chirba
From the introduction: Although ERISA preemption was ranked among the top "eight pertinent issues" that needed to be addressed in order to achieve comprehensive health care reform, Congress opted to avoid it when it passed the Patient Protection and Affordable Health Care Act on March 23, 2010, and the Health Care and Education Reconciliation Act just one week later ("PPACA" or the "Act", collectively). Currently 180 million Americans receive employer-sponsored health benefits, and millions more will do so once PPACA takes full effect over the next few years. This expansion of employer based coverage, coupled with what the Act does …
Medical Malpractice, The Affordable Care Act And State Provider Shield Laws: More Myth Than Necessity?, Mary Ann Chirba, Alice Noble
Medical Malpractice, The Affordable Care Act And State Provider Shield Laws: More Myth Than Necessity?, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, …
The Supreme Court On The Affordable Care Act: What We Are Waiting For, Mary Ann Chirba, Alice Noble
The Supreme Court On The Affordable Care Act: What We Are Waiting For, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
From the introduction: With the U.S. Supreme Court poised to rule on the Affordable Care Act (ACA) it is worth reminding ourselves of what, exactly, we have been waiting for. We await a judicial opinion that could deliver a decisive blow to all or part of a massive piece of legislation and the hard-fought battles that led to its enactment, or salvage the near-century-old quest for health care reform. At the same time we await an opinion that may reshape our fundamental understanding of the Court, the power of Congress, and long-standing principles of federalism.
The Supreme Court Upholds The Individual Mandate: But Who Are We Talking About?, Mary Ann Chirba, Alice Noble
The Supreme Court Upholds The Individual Mandate: But Who Are We Talking About?, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
From the introduction: While the Affordable Care Act’s individual mandate survived constitutional scrutiny in NFIB v. Sebelius, a Republican president and/or changes in the House or Senate this fall could lead to its demise. As campaigns shift into high gear, the law’s opponents will undoubtedly draw on the strident and jointly authored dissent of Justices Scalia, Kennedy, Thomas, and Alito. Despite the value of robust debate, relying on the dissent may be problematic due to its misperceptions about the ACA and the realities of health care. Thus, while we considered what we were waiting for in the weeks before the …
Our Bodies, Our Cells: Fda Regulation Of Autologous Adult Stem Cell Therapies, Mary Ann Chirba, Alice Noble
Our Bodies, Our Cells: Fda Regulation Of Autologous Adult Stem Cell Therapies, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated …
A Decade’S Quest For Safer Drugs: Congressional Committee Green Lights Regulation Of Drug Supply Chains And Compounding Manufacturers, Mary Ann Chirba, Alice Noble
A Decade’S Quest For Safer Drugs: Congressional Committee Green Lights Regulation Of Drug Supply Chains And Compounding Manufacturers, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment). Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation’s drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died …
Drawing Lines In Shifting Sands: The U.S. Supreme Court's Mixed Messages On Erisa Preemption Imperil Health Care Reform, Mary Ann Chirba
Drawing Lines In Shifting Sands: The U.S. Supreme Court's Mixed Messages On Erisa Preemption Imperil Health Care Reform, Mary Ann Chirba
Mary Ann Chirba
This article explains how and why the U.S. Supreme Court’s increasingly erratic preemption jurisprudence has fueled a health care system that routinely harms patients, frustrates health care providers, and derails state reform efforts. It begins by describing the mechanics of ERISA preemption, and then analyzes the Court’s 30 year odyssey from no preemption of state law claims against managed care payers, to broad preemption, retreating to limited preemption and, for now at least, trending again toward broad preemption. This is an extremely unstable area of the law which, at this point, demands not just an update but a thorough overview. …
An Uncertain Risk And An Uncertain Future: Assessing The Legal Implications Of Mercury Amalgram Fillings., Mary Ann Chirba-Martin, Carolyn M. Welshhans
An Uncertain Risk And An Uncertain Future: Assessing The Legal Implications Of Mercury Amalgram Fillings., Mary Ann Chirba-Martin, Carolyn M. Welshhans
Mary Ann Chirba
Trying to buy a mercury thermometer at the local pharmacy these days will result in a deluge of information regarding the risks of mercury and the proper disposal protocol for mercury thermometers as hazardous waste. Yet, inquiring about the risks of placing mercury in one’s mouth, in the form of a dental filling, is likely to meet with resounding assurances of safety from the dental profession. While such comforting disclaimers are meant to ease patient concerns, many continue to worry about the safety of dental mercury. This article will begin by describing the many safety concerns that surround the use …
Fda Oversight Of Autologous Stem Cell Therapies: Legitimate Regulation Of Drugs And Devices Or Groundless Interference With The Practice Of Medicine?, Mary Ann Chirba, Stephanie M. Garfield
Fda Oversight Of Autologous Stem Cell Therapies: Legitimate Regulation Of Drugs And Devices Or Groundless Interference With The Practice Of Medicine?, Mary Ann Chirba, Stephanie M. Garfield
Mary Ann Chirba
No abstract provided.
Avoiding The Avoidable: Why State Laws Need To Protect Kids From Airbags, Mary Ann Chirba
Avoiding The Avoidable: Why State Laws Need To Protect Kids From Airbags, Mary Ann Chirba
Mary Ann Chirba
No abstract provided.
Universal Health Care In Massachusetts: Setting The Standard For National Reform, Mary Ann Chirba
Universal Health Care In Massachusetts: Setting The Standard For National Reform, Mary Ann Chirba
Mary Ann Chirba
No abstract provided.
The Scope Of Federal Habeas Corpus Review: Rose V. Mitchell, Mary Ann Chirba
The Scope Of Federal Habeas Corpus Review: Rose V. Mitchell, Mary Ann Chirba
Mary Ann Chirba
No abstract provided.
Employers' Indirect Discrimination: Degrace V. Rumsfeld, Mary Ann Chirba
Employers' Indirect Discrimination: Degrace V. Rumsfeld, Mary Ann Chirba
Mary Ann Chirba
No abstract provided.
Seniority Systems: California Brewers Association V. Bryant, Mary Ann Chirba
Seniority Systems: California Brewers Association V. Bryant, Mary Ann Chirba
Mary Ann Chirba
No abstract provided.