Law Commons^™

Law School News: Rwu Law Professors Win Release For Two Immigrants At Risk For Covid-19 04-24-2020, Roger Williams University School Of Law

Life of the Law School (1993- )

No abstract provided.

Strategic Apologies In Medical Malpractice Mediation, Brittany Norman

Pepperdine Dispute Resolution Law Journal

Mistakes happen, even in a field as serious and careful as medicine. As a result, some patients are left with unexpected results from their medical procedures. Once hospitals inform patients of medical mistakes or the patients inform the hospital, the patients' cases are moved to the legal realm, where they are viewed as a liability. This shift causes the patient to feel as though the hospital does not recognize him or her and prevents doctors from apologizing to their patients, despite their desire to do so. In an attempt to apologize without vulnerability to liability, medical professionals are sometimes instructed …

Revitalizing Louisiana's Lost Chance Doctrine: Burchfield V. Wright Sheds Light On The Need For Medical Expenses, Madeleine K. Morgan

Louisiana Law Review

The article discusses the Louisiana Supreme Court case "Burchfield v. Wright" to examine the use of the 'lost chance doctrine' in medical malpractice lawsuits under the Louisiana Medical Malpractice Act (MMA).

Euthanasia Of The Coronavirus - Covid-19, Sheila P. Davis

Journal of Health Ethics

At the time of this editorial, COVID-19, aka the Novel Coronavirus, has wrecked havoc and left in its path of destruction, death, unemployment, the instability of nation’s economies, misery, uncertainty, despair, and a fear regarding what the new tomorrow will look like. And, perhaps more importantly, the question of who will be here tomorrow lingers. Now classified as a pandemic, this virus has resulted in over 1,381,014 cases worldwide with 78,269 deaths to date. Presently, Louisiana and Detroit are emerging as the next hot spots behind New York as the fastest rate of increase for COVID-19 cases in the world. …

Cummings V. Barber, 136 Nev. Adv. Op. 18 (April 2, 2020), Alexis Taitel

Nevada Supreme Court Summaries

No abstract provided.

The Baker Act: Time For Florida To Get Its Act Together, Alexander Lemieux

Child and Family Law Journal

No abstract provided.

Fertility Fraud And Proposal For Florida Legislation, Cheyenne Dunn

Child and Family Law Journal

No abstract provided.

(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein

Washington and Lee Law Review

This Article explores four beliefs about supposed pharma-benevolence that appear to be shared by more than the industry, reaching the level almost of conventional wisdom. These figurative pillars help support one-sided results in court. However, each of the pillars on examination turns out at least a bit shaky. This Article puts them forward for review to start a necessary discussion.

The locus of this Article is products liability, where a court concludes that a manufactured object is defective or could be called defective by a factfinder following a trial. Drug manufacturers enjoy near-immunity from this consequence. Modern products liability identifies …

Patent Eligibility Of Disease Diagnosis, Shahrokh Falati

Articles & Chapters

The U.S. Supreme Court effectively redefined the scope of patent eligible subject matter when it decided Mayo. This decision focused on medical diagnostic technology and has had a profound effect on the biotechnology and personalized medicine industries in the United States. Subsequent back-to-back decisions by the Supreme Court in Myriad and Alice have made it unequivocally clear that there is now wholesale broadening of the judicially created exceptions to statutory laws governing patent eligible subject matter. This has caused havoc in the biopharmaceutical industry by not only making it a near impossibility to obtain a patent in certain fields, but …

What Results Should Be Returned From Opportunistic Screening In Translational Research?, Colin M.E. Halverson, Sarah H. Jones, Laurie Novak, Christopher Simpson, Digna R. Velez Edwards, Sifang K. Zhao, Ellen W. Clayton

Vanderbilt Law School Faculty Publications

Increasingly, patients without clinical indications are undergoing genomic tests. The purpose of this study was to assess their appreciation and comprehension of their test results and their clinicians’ reactions. We conducted 675 surveys with participants from the Vanderbilt Electronic Medical Records and Genomics (eMERGE) cohort. We interviewed 36 participants: 19 had received positive results, and 17 were self-identified racial minorities. Eleven clinicians who had patients who had participated in eMERGE were interviewed. A further 21 of these clinicians completed surveys. Participants spontaneously admitted to understanding little or none of the information returned to them from the eMERGE study. However, they …

Amending The Ryan Haight Act: Elevating Telemedicine Law To New Heights, Dillon Vaughn

Texas A&M Law Review

The Ryan Haight Act has established excessive restrictions on controlled substance prescribing through telemedicine by first requiring an in-person exam. If the Act is not amended, many individuals in need of medication will go without proper medical care. While other agencies and states have made moves to expand telehealth, the DEA has dragged its feet on making any significant changes. This Comment argues that the federal government should amend the Ryan Haight Act, allowing telemedicine providers to prescribe controlled substances without an in-person exam. This amendment would focus on the standard of care while requiring stringent documentation by physicians who …

Ivf Errors - Is This Only The Tip Of The Iceberg?, Jody L. Madeira, Steven R. Lindheim Md, Mark P. Trolice

Articles by Maurer Faculty

ART errors are fortunately a rare occurrence. but humans are fallible and mistakes are inevitable. As social media sensationalizes these events, we, as infertility specialists, must be vigilant in reviewing existing risk management systems and consider other options to minimize/eliminate these events. ART programs should work to emphasize honesty and transparency to improve quality of care.

The Importance Of Doctor Liability In Medical Malpractice Law: China Versus The United States, Vincent R. Johnson

St. Mary's Journal on Legal Malpractice & Ethics

Medical malpractice law in China does not work. Disappointed patients and their families, or the gangs they hire, frequently resort to physical violence, beating up doctors and disrupting hospital activities in order to extort settlements. This happens because Chinese law has failed to provide viable remedies to many victims of medical malpractice.

This dysfunctional situation (medical chaos or yinao) has persisted for more than two decades. Today, parents in China discourage their children from attending medical school because practicing medicine is too dangerous.

Reforming Chinese medical malpractice law will be difficult. Many factors contribute to the public’s lack of confidence …

The Off-Label Loophole In The Psychopharmacologic Setting: Prescription Of Antipsychotic Drugs In The Nonpsychotic Patient Population, Lisa E. Smilan

Health Matrix: The Journal of Law-Medicine

U.S. physicians have wide discretion in treating patients with off-label medications. Many consider off-label prescription essential in our country’s health care system, and it is wholly supported by FDA and federal courts. Assumptions about physicians’ expertise, judgments, and commitments to beneficence and nonmaleficence undergird laissez-faire policies that allow and support physicians’ novel and innovate uses of FDA-approved drugs for purposes and populations not studied in original, strictly regulated clinical trials. Though sometimes beneficial, off-label prescribing, which flourishes in privatepractice psychiatry, often harms scores of psychiatric patients. Frequently, potential harms are insufficiently disclosed to patients. In the public health sector, officials …

Medical Civil Rights As A Site Of Activism: A Reply To Critics, Craig Konnoth

Publications

See Craig Konnoth, Medicalization and the New Civil Rights, 72 Stan. L. Rev. 1165 (2020).

See also Rabia Belt & Doron Dorfman, Response, Reweighing Medical Civil Rights, 72 Stan. L. Rev. Online 176 (2020), https://www.stanfordlawreview.org/online/reweighing-medical-civil-rights/; Allison K. Hoffman, Response, How Medicalization of Civil Rights Could Disappoint, 72 Stan. L. Rev. Online 165 (2020), https://www.stanfordlawreview.org/online/how-medicalization-of-civil-rights-could-disappoint/.

Cruzan’S Legacy In Autonomy, Kathy Cerminara

Faculty Scholarship

No abstract provided.

The Conscience Defense To Malpractice, Nadia N. Sawicki

Faculty Publications & Other Works

This Article presents the first empirical study of state conscience laws that establish explicit procedural protections for medical providers who refuse to participate in providing reproductive health services, including abortion, sterilization, contraception, and emergency contraception.

Scholarship and public debate about law's role in protecting health care providers' conscience rights typically focus on who should be protected, what actions should be protected, and whether there should be any limitations on the exercise of conscience rights. This study, conducted in accordance with best methodological practices from the social sciences for policy surveillance and legal mapping, is the first to provide concrete data …

Video Advance Directives: Growth And Benefits Of Audiovisual Recording, Thaddeus Pope

Faculty Scholarship

The key question in Cruzan v. Director, Missouri Department of Health was one of substantiation and evidence: how can the incapacitated patient’s surrogate decision maker prove that the health care decisions she makes on the patient’s behalf are the same health care decisions that the patient would have made for herself? Answering this question, the Court observed that an advance directive would constitute adequate proof because an advance directive constitutes clear and convincing evidence of a patient’s wishes.

Today, clinicians and policymakers no longer focus on the constitutional question of how much evidence state law may require from a patient’s …

What Is The Trade-Off: Are New Trade Deals Worth The Changes To Pharmaceutical Patents?, Kaitlyn Carter

Marquette Intellectual Property Law Review

None.

The Injustice Of New York’S Notice Of Claim Limitations In Medical Malpractice Actions, Jessica Simon

NYLS Law Review

No abstract provided.

Encomium For Karen Rothenberg, Ellen W. Clayton

Vanderbilt Law School Faculty Publications

Karen is also a zealous advocate in the very best sense of the word. After Struewing's article appeared, she wrote an editorial that appeared in multiple newspapers arguing that women with these variants should not lose their insurance. She became deeply involved in the National Action Plan for Breast Cancer, a powerful grass roots organization. Additionally, she became involved at the National Institutes of Health and addressed, often in leadership roles, such issues to develop strategies to prevent genetic discrimination for individuals with variants that increased the risk of developing cancer, to create tools to obtain meaningful informed consent for …

Unjust Timing Limitations In Genetic Malpractice, Ellen W. Clayton, Gary Marchant, Bonnie Leroy, Lauren Clatch

Vanderbilt Law School Faculty Publications

As genomic data are increasingly being collected and applied in clinical care, physicians, laboratories, and other health care providers are more frequently being sued for alleged medical malpractice or negligence. Because the genetic underpinnings of an existing or future health condition may not be immediately apparent, such cases sometimes raise unique timing issues involving the applicable statute of limitations, statute of repose, or statutory notification requirements. Although these timing limitations on when a lawsuit can be brought have important policy rationales and justifications, such as helping to protect providers from open-ended liability, their application to genetic liability cases may sometimes …

Patents, Information, And Innovation, Brenda M. Simon

Faculty Scholarship

Inventors and commercialization partners often rely on patents to facilitate the exchange of sensitive information. Most scholarship in this area has focused on the areas of software and biotechnology. To provide a richer description of the role of patents in the innovative process, this project evaluates the existing literature and sets forth examples drawn from a series of interviews with professionals from the largely-overlooked medical device industry. The limited analysis of the medical device industry has focused on the largest few dozen firms—as publicly-traded entities, a great deal of data about them is readily available. Small medical device companies are …

Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval …

Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder

Articles, Book Chapters, & Popular Press

Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …

Assisted Dying And Evidence-Based Law-Making: A Critical Analysis Of An Article’S Role In New Zealand’S Referendum, Ben White, Lindy Willmott, Jocelyn Downie, Andrew Geddis, Colin Gavaghan

Articles, Book Chapters, & Popular Press

Aim: To critically analyse the reliability of an article which claims to be evidence that the End of Life Choice Act 2019 provides a “potential hotspot for family, community and social discord that may not be easily remedied” should the legislation receive public support in New Zealand’s September 2020 referendum.

Method: The subject article was reviewed multiple times by all authors and critiqued against three criteria: a reliability pyramid developed to weigh evidence about assisted dying; principles that guide the conduct of social science research; and the use of reliable and current social science literature to support factual claims.

Results: …

Saving The Electronic Person From Digital Assault: The Case For More Robust Protections Over Our Electronic Medical Records, Danielle M. Mrdjenovich

Duquesne Law Review

No abstract provided.

A Commitment To The Whole Athlete: Embracing The Role Of Cannabinoids In Collegiate Athletics, Kelli Rodriguez Currie

Seattle University Law Review

Cannabinoids can be a highly effective way for athletes to combat various kinds of pain associated with intense training. Derivatives of cannabis, such as marijuana, have been used for centuries as a form of pain relief. Part I of this Article discusses how cannabinoids are used in sports medicine. Part II discusses the different approaches to marijuana and cannabidiol use across sports leagues. Part III highlights the inconsistencies between the NCAA’s approach to testing for substance abuse and its investment in student-athletes’ well-being. Part IV discusses how the NCAA must focus on student-athlete health. Finally, Part V concludes that the …

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …

Torts: Just Walk Away: How An Overbroad Foreseeability Of Harm Standard Could Kill “Curbside Consultations” — Warren V. Dinter, 926 N.W.2d 370 (Minn. 2019), Erika Miller

Mitchell Hamline Law Review

No abstract provided.