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The Wild, Wild West Of Laboratory Developed Tests, John Gilmore Mar 2024

The Wild, Wild West Of Laboratory Developed Tests, John Gilmore

Washington and Lee Law Review Online

Since the 1950’s, scientists have built novel technologies to screen for genetic diseases and other biological irregularities. Recently, researchers have developed a method called “liquid biopsy” (as opposed to a standard tissue biopsy) that uses a liquid sample (e.g., blood) to non‑invasively spot biomarkers indicating different types of cancers in the patient’s body. While the U.S. Food and Drug Administration (FDA) has fully cleared a small number of liquid biopsy tests under its rigorous and expensive review process, most biotech companies have instead followed a less restrictive regulatory path through the Centers for Medicare and Medicaid Services (CMS), which label …


Constitutional Confidentiality, Natalie Ram, Jorge L. Contreras, Laura M. Beskow, Leslie E. Wolf Oct 2023

Constitutional Confidentiality, Natalie Ram, Jorge L. Contreras, Laura M. Beskow, Leslie E. Wolf

Washington and Lee Law Review

Federal Certificates of Confidentiality (“Certificates”) protect sensitive information about human research subjects from disclosure and use in judicial, administrative, and legislative proceedings at both the state and federal levels. When they were first authorized by Congress in the 1970s, Certificates covered sensitive information collected in research about drug addiction use. Today, however, they extend to virtually all personal information gathered by biomedical research studies. The broad reach of Certificates, coupled with their power to override state subpoenas and warrants issued in the context of law enforcement, abortion regulation, and other police powers typically under state control, beg the question whether …


Deserving Life: How Judicial Application Of Medical Amnesty Laws Perpetuates Substance Use Stigma, Scott Koven Oct 2023

Deserving Life: How Judicial Application Of Medical Amnesty Laws Perpetuates Substance Use Stigma, Scott Koven

Washington and Lee Law Review

To combat the continued devastation wrought by the opioid crisis in the United States, forty-eight states have passed medical amnesty (or “Good Samaritan”) laws. These laws provide varying forms of protection from criminal punishment for certain individuals if medical assistance is sought at the scene of an overdose. Thus far, the nascent scholarly conversation on medical amnesty has focused on the types of statutory protections available and the effectiveness of these statutes. To summarize, although medical amnesty laws have helped combat drug overdose, the statutes are replete with arbitrary limitations that cabin their life-saving potential.

This Note extends the dialogue …


Gag With Malice, Shaakirrah R. Sanders Jan 2023

Gag With Malice, Shaakirrah R. Sanders

Washington and Lee Law Review

This Article brings agriculture privacy and other commercial gagging laws into the ongoing debate on the First Amendment actual malice rule announced in New York Times v. Sullivan. Despite a resurgence in contemporary jurisprudence, Justices Clarence Thomas and Neil Gorsuch have recently questioned the wisdom and viability of Sullivan, which originally applied actual malice to state law defamation claims brought by public officials. The Court later extended the actual malice rule to public figures, to claims for infliction of emotional distress, and—as discussed in this Article—to claims for invasion of privacy and to issues of public importance or concern.

United …


High Time For Change: The Legalization Of Marijuana And Its Impact On Warrantless Roadside Motor Vehicle Searches, Molly E. O'Connell Oct 2022

High Time For Change: The Legalization Of Marijuana And Its Impact On Warrantless Roadside Motor Vehicle Searches, Molly E. O'Connell

Washington and Lee Law Review Online

The proliferation of marijuana legalization has changed the relationship between driving and marijuana use. While impaired driving remains illegal, marijuana use that does not result in impairment is not a bar to operating a motor vehicle. Scientists have yet to find a reliable way for law enforcement officers to make this distinction. In the marijuana impairment context, there is not a scientifically proven equivalent to the Blood Alcohol Content standard nor are there reliable roadside assessments. This scientific and technological void has problematic consequences for marijuana users that get behind the wheel and find themselves suspected of impaired driving. Without …


Comment: On Patents And Appropriations—And Tragedies, David O. Taylor Jan 2022

Comment: On Patents And Appropriations—And Tragedies, David O. Taylor

Washington and Lee Law Review

I write to provide a few remarks concerning Sasha Hoyt’s illuminating work published in the pages of this journal. In it, Hoyt addresses the impact of the Supreme Court’s patent eligibility decisions on private investment in the development of medical diagnostic technologies. As an initial matter, I want to congratulate Hoyt for tackling an important topic. As Hoyt discusses, medical diagnostic technologies enable the diagnosis of diseases and other medical conditions such as genetic disorders, and early and accurate diagnosis may lead to early treatments and, ultimately, at least in some cases, saved lives. But the creation of medical diagnostic …


Patent Eligibility And Cancer Therapy, Christopher B. Seaman Jan 2022

Patent Eligibility And Cancer Therapy, Christopher B. Seaman

Washington and Lee Law Review

As an empirical legal scholar, I am pleased to report that Sasha Hoyt has done what very few law students—and even many law professors—could achieve. She successfully conducted a novel empirical study to assess the real-world impact of a U.S. Supreme Court decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc., on venture capital (VC) investment in startups and other companies that develop medical diagnostic technology.

As Ms. Hoyt notes, patent protection is particularly important for startup companies, as it can help protect their innovations from unauthorized use, attract funding and other investments, and foster collaboration with third parties. In …


What’S The Beef? The Fda, Usda, And Cell-Cultured Meat, Tammi S. Etheridge Jan 2022

What’S The Beef? The Fda, Usda, And Cell-Cultured Meat, Tammi S. Etheridge

Washington and Lee Law Review

Over the past ten years, administrative law scholarship has increasingly focused on interactions between multiple agencies. As part of this trend, most scholars have called for policymakers to combine multiple agencies, rather than rely on a single agency, to solve policy problems. The literature in this area espouses the benefits of shared regulatory space. But very little of this scholarship addresses when shared jurisdiction is problematic. This is particularly concerning when an agency opts into or cedes oversight authority to another agency at will, with little regard for whether the second agency is an appropriate regulator. The case of cell-cultured …


The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt Jan 2022

The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt

Washington and Lee Law Review

Historically, 35 U.S.C. § 101, the statute governing patent eligible subject matter, has been construed broadly—with its legislative history indicating that it should cover “anything under the sun that is made by man.” The Supreme Court crafted three exceptions to § 101: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. In recent years, the Supreme Court’s eligibility jurisprudence has further narrowed § 101 to effectively exclude meritorious medical diagnostic methods. Indeed, since the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Federal Circuit has held every single diagnostic method claim brought before it …


Blood In The Water: Why The First Step Act Of 2018 Fails Those Sentenced Under The Maritime Drug Law Enforcement Act, Lauren R. Robertson Oct 2021

Blood In The Water: Why The First Step Act Of 2018 Fails Those Sentenced Under The Maritime Drug Law Enforcement Act, Lauren R. Robertson

Washington and Lee Law Review

For some, the open ocean is prison. The Maritime Drug Law Enforcement Act (MDLEA) prohibits individuals from knowingly or intentionally distributing a controlled substance or possessing it with the intent to distribute. Empowered by the MDLEA, the United States Coast Guard arrests and detains foreign nationals hundreds of miles outside of U.S. territorial waters. After months shackled to Coast Guard ships, these individuals face the harsh reality of American mandatory minimum drug sentencing, judged by the kilograms of drugs on their vessels. But the MDLEA conflates kilograms with culpability. More often than not, those sentenced are fishermen-turned-smugglers due to financial …


The Public Health Turn In Reproductive Rights, Rachel Rebouché Oct 2021

The Public Health Turn In Reproductive Rights, Rachel Rebouché

Washington and Lee Law Review

Over the last decade, public health research has demonstrated the short-term, long-term, and cumulative costs of delayed or denied abortion care. These costs are imposed on people who share common characteristics: abortion patients are predominantly low income and disproportionately people of color. Public health evidence, by establishing how law contributes to the scarcity of services and thereby entrenches health disparities, has vividly highlighted the connections between abortion access, race, and income. The contemporary attention to abortion law’s relationship to inequality is no accident: researchers, lawyers, and advocates have built an infrastructure for generating credible empirical studies of abortion restrictions’ effects. …


The Fda’S Power Over Non-Therapeutic Uses Of Drugs And Devices, Patricia J. Zettler Jan 2021

The Fda’S Power Over Non-Therapeutic Uses Of Drugs And Devices, Patricia J. Zettler

Washington and Lee Law Review

Although we often—and rightly—think of the U.S. Food and Drug Administration (FDA) as regulating important therapies for patients, the agency also can regulate non-therapeutic uses of drugs and devices. The Federal Food, Drug, and Cosmetic Act defines drugs and devices as including not only products intended to address disease but also those intended to affect the structure or function of the body, such as cognitive enhancements, wrinkle removers, and recreational drugs. Indeed, if these broad definitions were read literally, many everyday consumer products—such as winter jackets intended to keep wearers’ warm—may be drugs or devices. Accordingly, Congress, courts, and the …


(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein Mar 2020

(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 …


Fighting America’S Best-Selling Product: An Analysis Of And Solution To The Opioid Crisis, Ashley Duckworth Jan 2020

Fighting America’S Best-Selling Product: An Analysis Of And Solution To The Opioid Crisis, Ashley Duckworth

Washington and Lee Journal of Civil Rights and Social Justice

Deaths from drug overdoses have doubled over the last ten years and are now the leading cause of accidental death in the United States. Although some overdoses may have involved more than one drug, prescription and/or illicit opioids were involved in many of these drug overdose fatalities. The Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC), and Congress have enacted a string of regulations, statutes, and programs since the early 1990s, but nothing has seriously improved the opioid epidemic as it stands. If anything, the use of opioids has persisted. Many people want pharmaceutical companies to …


The Formulary Fix Buries Fritz & Harvey: Drug Promotion Escapes Its Past Constraints, James T. O'Reilly Jan 2018

The Formulary Fix Buries Fritz & Harvey: Drug Promotion Escapes Its Past Constraints, James T. O'Reilly

Washington and Lee Law Review

No abstract provided.


The Off-Label Use Of Pom Wonderful: Using Section 43(A) To Eliminate Misleading Off-Label Drug Promotion, Christopher A. Hurley Jan 2018

The Off-Label Use Of Pom Wonderful: Using Section 43(A) To Eliminate Misleading Off-Label Drug Promotion, Christopher A. Hurley

Washington and Lee Law Review

No abstract provided.


Reconciling The Lanham Act And The Fdca: A Comment On Chris Hurley’S Note, Christopher B. Seaman Jan 2018

Reconciling The Lanham Act And The Fdca: A Comment On Chris Hurley’S Note, Christopher B. Seaman

Washington and Lee Law Review

No abstract provided.


An Examination Of Trans Fat Labeling: Splitting The Third & Ninth Circuit, Jack Gainey Apr 2017

An Examination Of Trans Fat Labeling: Splitting The Third & Ninth Circuit, Jack Gainey

Washington and Lee Journal of Civil Rights and Social Justice

At first glance, consumer claims alleging misleading labeling would seem to find a simple resolution. Under 21 U.S.C. § 343, which governs misbranded food, a food product is misbranded if “its labeling is false or misleading.” However, controversial interpretation of seemingly straightforward statutory language, together with evolving case law, have blurred a once clear picture. Disagreement over the federal preemption of consumer claims regarding trans fat, underscored by a dispute regarding standing, have combined to create a divergence of opinions between courts across the country.

In 2011, the United States District Court for the Northern District of California considered a …


Pharmaceutical Efficacy: The Illusory Legal Standard , Jonathan J. Darrow Sep 2013

Pharmaceutical Efficacy: The Illusory Legal Standard , Jonathan J. Darrow

Washington and Lee Law Review

The very long and expensive process of new drug research and development might suggest to observers that the efficacy standard for drugs is elevated and substantial, but this is not the case. Under the U.S. Federal Food, Drug, and Co smetic Act, new drug approval merely requires that there be “substantial evidence that the drug will have the effect it purports or is represented to have.” While the evidence of effectiveness must therefore be substantial, the efficacy attested to by that evidence need not surpass any particular threshold (other than zero), thus allowing drugs with de minimis efficacy to be …


Are Food Subsidies Making Our Kids Fat? Tensions Between The Healthy Hunger-Free Kids Act And The Farm Bill, Melissa D. Mortazavi Sep 2011

Are Food Subsidies Making Our Kids Fat? Tensions Between The Healthy Hunger-Free Kids Act And The Farm Bill, Melissa D. Mortazavi

Washington and Lee Law Review

On December 15, 2010, President Obama signed the Healthy Hunger- Free Kids Act of 2010 (HHFKA)1 into law. It was hailed as a bipartisan success and a significant reform of childhood nutrition policy. Indeed, on its surface the law appears to make a significant shift away from the food paradigm of the past. However, upon closer examination, it fails to unwind the tangled connections between domestic eating habits and longstanding farm subsidies. This Article breaks new ground in several ways: First, it is one of the first essays in the emerging and underexplored field of food law, a crosssection of …


Inwood Laboratories, Inc. V. Ives Laboratories, Inc., Lewis F. Powell Jr. Oct 1981

Inwood Laboratories, Inc. V. Ives Laboratories, Inc., Lewis F. Powell Jr.

Supreme Court Case Files

No abstract provided.


Regulation Of Prescription Drug Discount Advertising Sep 1967

Regulation Of Prescription Drug Discount Advertising

Washington and Lee Law Review

No abstract provided.