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Full-Text Articles in Law
Addressing Prescription Opioid Abuse Concerns In Context: Synchronizing Policy Solutions To Multiple Public Health Problems, Kelly Dineen
Addressing Prescription Opioid Abuse Concerns In Context: Synchronizing Policy Solutions To Multiple Public Health Problems, Kelly Dineen
Kelly Dineen
No abstract provided.
Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski
Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski
Michael J. Malinowski
This Commentary is part of a colloquy on race-based genetics research.
A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
Michael J. Malinowski
This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.
United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski
United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski
Michael J. Malinowski
This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.
Could You Repeat That Please? Forty-Five Years Of Testing Pesticides On People, Barbara R. Leiterman Esq.
Could You Repeat That Please? Forty-Five Years Of Testing Pesticides On People, Barbara R. Leiterman Esq.
Barbara R. Leiterman Esq.
Little has been published in the literature about pesticide experiments conducted on human subjects. Yet there were at least twenty-two tests between 1967 and 2011 in which people were intentionally exposed to specific doses of pesticides. Almost all of these experiments violated scientific ethics and human rights. This article aims to describe those tests and their shortcomings, and explore the laws and regulations that incentivize such human experimentation. Ironically, as the public desire for pesticide safety increases, so does the industry’s motivation to test pesticides on people. Bringing these pesticide experiments to light, expanding the public discourse on the subject …
Flag On The Play: The Ninth Circuit’S End-Run Around Implied Rights Of Action Runs Afoul In County Of Santa Clara V. Astra, Usa Inc., Brooke Burns
Brooke Burns
In County of Santa Clara v. Astra, USA Inc., the Ninth Circuit held that a third party was entitled to bring a private right of action for breach of contract under federal common law, even though the governing statute neither expressly nor impliedly provides for this right. Because the Supreme Court has increasingly limited the ability of a third party to bring an implied right of action claim, private parties have pursued third party beneficiary claims instead. As a result, a considerable circuit split has resulted as to whether federal common law provides a private right of action to a …
A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
Michael J. Malinowski
This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.
An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin
An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin
Margarita Rubin
ABSTRACT Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a viable target for state tort claims. In February, 2008 the Supreme Court handed down a crucial decision in Riegel v. Medtronic, Inc., involving medical devices regulated by the FDA. In Riegel, the Court reaffirmed the distinction between the exhaustive "federal requirements" of the PMA process and the looser scrutiny of 510(k) notification. This means that 510(k) devices—which vastly outnumber PMA devices—remain fully exposed to mass-tort liability. Medical …
Responding, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski
Responding, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski
Michael J. Malinowski
This Commentary is part of a colloquy on race-based genetics research.
International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth
International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth
Gary E. Marchant
Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether …
Biomedical Research And The Law:--Embryonic Stem Cells, Clones And Genes: Science, Law, Politics, And Values, Michael J. Malinowski
Biomedical Research And The Law:--Embryonic Stem Cells, Clones And Genes: Science, Law, Politics, And Values, Michael J. Malinowski
Michael J. Malinowski
This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.