Narrowing In On The Problem: A Component-Level Analysis Of "Hybrid" Medical Devices, 2019 Boston College Law School
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 ...
The Case Of The Religious Gay Blood Donor, 2019 College of William & Mary Law School
The Case Of The Religious Gay Blood Donor, Brian Soucek
William & Mary Law Review
The Food and Drug Administration (FDA) prohibits sexually active gay men from donating blood. This Article envisions an original legal challenge to that rule: not the predictable equal protection suit, but a religious freedom claim brought by a gay man who wants to give blood as an act of charity. Because the FDA’s regulations substantially burden his exercise of religion—requiring a year of celibacy as its price—the FDA would be forced to show that its policy is the least restrictive means of preventing HIV transmission through the blood supply. Developments in testing technology and the experience of ...
Non-Physician Vs. Physician: Cross-Disciplinary Expert Testimony In Medical Negligence Litigation, 2019 John Marshall Law School
Non-Physician Vs. Physician: Cross-Disciplinary Expert Testimony In Medical Negligence Litigation, Marc D. Ginsberg
Georgia State University Law Review
The source of the applicable standard of care in a specific medical negligence claim is multifaceted. The testifying expert witness, when explaining the applicable standard of care, “would draw upon his own education and practical frame of reference as well as upon relevant medical thinking, as manifested by literature, educational resources and information available to practitioners, and experiences of similarly situated members of the profession.” Accordingly, in typical medical negligence litigation, the plaintiff’s expert witness testifying regarding the existence of and the defendant-physician’s deviation from the standard of care would be a physician. Why, then, have courts permitted ...
Hard Choices And Deficient Choosers, 2019 Stanford Law School
Hard Choices And Deficient Choosers, Mark Kelman
Northwestern Journal of Law & Social Policy
No abstract provided.
The Ever-Changing Landscape Of Informed Consent And Whether The Obligation To Explain A Procedure To The Patient May Be Delegated, Samuel D. Hodge, Maria Zambrano Steinhaus
Arkansas Law Review
Informed consent is an integral part of the shared decision making process and requires a patient be informed of the benefits, risks and alternatives to a medical procedure. This information, which requirement has been codified into the law and practice of every healthcare provider, helps a patient decide whether to proceed with the recommended treatment plan. Informed consent has its foundation in the ethical notion of patient autonomy and fundamental human rights. After all, it is the patient’s decision to determine what may be done to his or her body and to ascertain the risks and benefits before undertaking ...
Table Of Contents, 2019 Seattle University School of Law
Table Of Contents, Seattle University Law Review
Seattle University Law Review
No abstract provided.
The Illusion Of Autonomy In Women's Medical Decision-Making, 2019 University of Louisville Louis D. Brandeis School of Law
The Illusion Of Autonomy In Women's Medical Decision-Making, Jamie R. Abrams
Jamie R. Abrams
This Article considers why there is not more conflict between women and their doctors in obstetric decision-making. While patients in every other medical context have complete autonomy to refuse treatment against medical advice, elect high-risk courses of action, and prioritize their own interests above any other decision-making metric, childbirth is viewed anomalously because of the duty to the fetus that the state and the doctor owe at birth. Many feminist scholars have analyzed the complex resolution of these conflicts when they arise, particularly when the state threatens to intervene to override the birthing woman’s autonomy.
This Article instead considers ...
Informed Consent: No Longer Just What The Doctor Ordered? Revisited, 52 Akron L. Rev. 49 (2018), 2019 John Marshall Law School
Informed Consent: No Longer Just What The Doctor Ordered? Revisited, 52 Akron L. Rev. 49 (2018), Marc Ginsberg
Marc D. Ginsberg
The law of informed consent in medicine has evolved from the original doctrine which required the physician's disclosure of the risks, benefits, and complications of (and alternatives to) a proposed procedure or treatment. The doctrine now implicates the disclosure of matters personal to the physician. Questions regarding the breadth of the doctrine in other respects have developed as well. This paper represents the author's second examination of the unconventional aspects of the law of informed consent.
Dr. Tele-Corporation: Bridging The Access-To-Care Gap, 2019 Penn State Dickinson Law
Dr. Tele-Corporation: Bridging The Access-To-Care Gap, Nader Amer
Dickinson Law Review
The United States is currently confronting an access-to-healthcare crisis, which rural regions are experiencing at a disproportionate rate. Many commentators have touted telemedicine as a solution for the access-to-care issue. Telemedicine uses video and telecommunication technology to allow physicians to treat patients from distant locations and thus facilitates a more equal distribution of physicians throughout the United States.
Although the telemedicine industry is quickly growing, the corporate practice of medicine doctrine impedes the industry’s expansion and consequently obstructs a viable solution to the access-to-care crisis. Generally, the corporate practice of medicine doctrine prohibits corporations and limited liability companies from ...
Situational Irony? How Implementing A Medicaid Block Grant Will Exacerbate Everything It Purports To Fix, 2018 Brigham Young University Law School
Situational Irony? How Implementing A Medicaid Block Grant Will Exacerbate Everything It Purports To Fix, Brent Miller
BYU Law Review
No abstract provided.
Halted Innovation: The Expansion Of Federal Jurisdiction Over Medicine And The Human Body, 2018 SJ Quinney College of Law, University of Utah
Halted Innovation: The Expansion Of Federal Jurisdiction Over Medicine And The Human Body, Myrisha S. Lewis
Utah Law Review
Modern medical innovations are blurring the line between medical practice and medical devices and drugs. Historically, many techniques have been developed in medicine, without any interference from the federal government, as medical practice is (and has historically been) an area of state jurisdiction. Over the past two decades, however, the U.S. Food and Drug Administration (FDA) has been exerting jurisdiction over the human body and the practice of medicine by targeting new medical techniques for oversight and subjecting the continued use of those treatments to onerous and legally questionable regulatory requirements that hinder the use of those treatments in ...
A Data Set Of Bloodstain Patterns For Teaching And Research In Bloodstain Pattern Analysis: Gunshot Backspatters, 2018 Iowa State University
A Data Set Of Bloodstain Patterns For Teaching And Research In Bloodstain Pattern Analysis: Gunshot Backspatters, Daniel Attinger, Yu Liu, Ricky Faflak, Yalin Rao, Bryce A. Struttman, Kris De Brabanter, Patrick M. Comiskey, Alex L. Yarin
Mechanical Engineering Publications
This is a data set of blood spatter patterns scanned at high resolution, generated in controlled experiments. The spatter patterns were generated with a rifle or a handgun, and different ammunitions. The resulting atomized blood droplets travelled opposite to the bullet direction, generating a gunshot backspatter on a poster board target sheet. Fresh blood with anticoagulants was used; its hematocrit and temperature were measured. Main parameters of the study were the bullet shape, size and speed, and the distance between the blood source and target sheet. Several other parameters were explored in a less systematic way. This new and original ...
"Wrongful Birth" Claims And The Paradox Of Parenting A Child With A Disability, 2018 CUNY School of Law
"Wrongful Birth" Claims And The Paradox Of Parenting A Child With A Disability, Sofia Yakren
Fordham Law Review
“Wrongful birth” is a controversial medical malpractice claim raised by the mother of a child born with a disability against a medical professional whose failure to provide adequate prenatal information denied her the chance to abort. Plaintiff-mothers are required to testify that, but for the defendant’s negligence, they would have terminated their pregnancy. Accordingly, alongside pro-life activists, disability rights advocates have opposed “wrongful birth” claims for stigmatizing and discriminating against people with disabilities by framing their very existence as a harm. Despite plaintiff-mothers’ need for caretaking resources, scholars have recommended solutions ranging from the wholesale elimination of the wrongful ...
Editing Nature: Reconceptualizing Biotechnology Governance, 2018 University of North Carolina School of Law
Editing Nature: Reconceptualizing Biotechnology Governance, Jonas J. Monast
Boston College Law Review
CRISPR-Cas9 (CRISPR) and other advances in gene editing techniques are fostering a rapid evolution within the field of biotechnology. Scientists can now modify the DNA of living organisms with precision by removing undesirable traits or inserting desirable traits. The edits may impact a single organism or result in genetic alterations that are designed to pass on to offspring (referred to as “gene drives”), potentially altering or eradicating an entire species. Prior to the discovery of the CRISPR gene editing process, the state of the technology presented barriers to widespread and precise genetic engineering. CRISPR changes the equation. With fewer technological ...
Medico-Legal Collaboration Regarding The Sex Offender: Othering And Resistance, 2018 Texas A&M University School of Law
Medico-Legal Collaboration Regarding The Sex Offender: Othering And Resistance, Mary Lay Schuster, Brian N. Larson, Amy D. Propen
We examined medico-legal collaboration regarding dangerous sex offenders where state legislators have adopted statutes that determine the criteria for commitment to and discharge from civil commitment programs. The application of these statutes relies on medical diagnoses of pathologies such as paraphilia, anti-social personality disorder, and pedophilia along with prognoses for cure or recidivism. In our study, we examined court opinions from commitment hearings and observed a trial in federal court on the constitutionality of these commitments. We found that one result of this medico-legal collaboration is the marginalization or othering of sex offenders by essentializing, dividing, shaming, and impeaching them ...
Reversal Of Fortune: Moving Pharmaceuticals From Over-The-Counter To Prescription Status?, 2018 Villanova University Charles Widger School of Law
Reversal Of Fortune: Moving Pharmaceuticals From Over-The-Counter To Prescription Status?, Lars Noah
Villanova Law Review
No abstract provided.
Neurohype And The Law: A Cautionary Tale, 2018 University of Pennsylvania Law School
Neurohype And The Law: A Cautionary Tale, Stephen J. Morse
Faculty Scholarship at Penn Law
This chapter suggests that for conceptual, empirical, and practical reasons, neuroscience in general and non-invasive brain imaging in particular are not likely to revolutionize the law and our conception of ourselves, but may make modest contributions to legal policy and case adjudication if the legal relevance of the science is properly understood.
Understanding The Sexual Assault Kit Backlog In Pennsylvania, 2018 Duquesne University
Understanding The Sexual Assault Kit Backlog In Pennsylvania, Kallie Crawford, Lyndsie Ferrara
Graduate Student Research Symposium
According to the FBI, to date, there are more than 400,000 untested sexual assault kits nationwide. While this is a huge issue that cannot be solved overnight, continual improvements and changes are needed to reduce and hopefully eliminate the backlog.
This research examines work going on nationwide and aims to better understand the backlog issues specifically in Pennsylvania. Furthermore, the research examines a program utilized by the law enforcement community that garnered necessary resources. First, a comprehensive review of improved practices in proactive jurisdictions of Ohio, Houston, Texas, and Detroit, Michigan was conducted to identify general policies and procedures ...
Avoiding Prolonged Dementia, 2018 Rutgers Law School - Newark
Avoiding Prolonged Dementia, Norman L. Cantor
Health Care Referrals Out Of The Shadows: Recognizing The Looming Threat Of The Texas Patient Solicitation Act And Other Illegal Remuneration Statutes, Trenton Brown
St. Mary's Law Journal