Food and Drug Law Commons^™

Pragmatic Conceptualism, Public Nuisance, And The American Opioid Litigation, Benjamin C. Zipursky

Washington and Lee Law Review

Public nuisance as a part of American tort law has been as high profile in the first decades of this century as products liability law was in the last several decades of the twentieth century. The American opioid litigation over the past decades is a spectacular example, filling headlines and generating billions of dollars of settlements. There is a plausible argument, however, that the doctrinal core of the opioid litigation is meritless because there simply is no “interference with public right” as required by public nuisance law. The first aim of this Article is to articulate and assess that argument. …

Drug War Repair Guarantees, Amber Baylor

Washington and Lee Law Review

Drug legalization, especially cannabis legalization, is a critical step forward in states’ willingness to address systemic disparities, privacy intrusions, violence, and other harms of the drug war. Yet, reforms center on legalization and repair through a narrow lens, focused on changes to the penal code. The public has found that narrow forms of legalization cannot serve their purported reparative purpose. Narrowly drawn legalization is illusory. Drug war harms and punishment for legalized substance use continue. Legalization reforms are vulnerable to political trends, resulting in rollback and retrenchment of drug war operations.

Legalization cannot deliver on its reparative terms without guarantees. …

Leveling The Playing Field? Exploring The Moral Ambiguity Of The Private Attorney General Model, Nathan Heastie

Washington and Lee Law Review Online

Johnson & Johnson’s market cap is twice the GDP of Oklahoma. So, when Oklahoma hauled Johnson & Johnson and other behemoth pharmaceutical companies into state court for their participation in the opioid epidemic, Big Pharma’s resources created a David v. Goliath situation. Against all odds, Oklahoma stood toe-to-toe with Big Pharma and brought home more than $650 million in settlement funds.

Oklahoma’s success would be otherwise impossible without the assistance of three private law firms serving the role of “private attorneys general.” The State signed contingency fee arrangements with the firms, transferring the financial burden of litigation from the State …

Pardon Me Please: Evaluating Clemency For Marijuana Offenders, Mitchell F. Crusto

Washington and Lee Law Review Online

Since 2012, several states and municipalities have decriminalized the non-violent use and possession of small amounts of recreational marijuana by adults. These criminal law reforms raise the issue of whether individuals who were convicted in the past should be exonerated retroactively by way of pardons or clemency. Consequently, many past marijuana offenders remain in state prisons for committing acts that are no longer deemed illegal in many states. Furthermore, these prisoners, as well as persons who were formerly accused or imprisoned, suffer from the stigma and negative collateral consequences of their alleged criminality. In response to these injustices, many governors …

Double Dosing: How Brand-Name Pharmaceutical Manufacturers Manipulate Patent Rules To Extend Market Exclusivity, Elizabeth Hertzberg

Washington and Lee Law Review

A robust patent system is important for spurring innovation, but it is not without risk. Because a patent owner has exclusivity over the patented subject matter for a specific term, there is incentive to extend that monopoly however possible. Identical subject matter is unpatentable, but obvious variants of an existing patent may be allowed if the applicant agrees to the same expiration date for both patents. This agreement is called a terminal disclaimer. While patents tied together with terminal disclaimers may not necessarily lead to unjust patent term extensions, an army of terminal disclaimers directed at one invention presents a …

Cultivating Legal Protection: Replacing Wine Labeling Regulations With Regional Certification Marks, David Corasaniti

Washington and Lee Law Review Online

While wine labeling in the United States is currently governed by a complex regulatory framework administered by the Alcohol and Tobacco Tax and Trade Bureau (“TTB”), intellectual property (“IP”) rights for wine producing regions could serve this core function of protecting consumers better and more efficiently. Regulating wine labeling through IP would more closely mirror the system used by the European Union, which recognizes Geographical Indications, such as Champagne, Rioja, and Bordeaux, as a unique form of IP. By deregulating American wine labeling, and encouraging wine producing regions to assert their IP rights in the form of collectively held certification …

Cannabis At Work: Navigating The Intersection Of Employment Law And Legalized Marijuana, Eva Lane

Washington and Lee Journal of Civil Rights and Social Justice

As states increasingly legalize forms of cannabis use, federal regulation remains stagnant. These outdated laws still hold power, undermining state-granted rights. This impact is especially felt in the employment sector. While states pass laws legalizing cannabis use, employers still have a right to a drug free workplace. Many employment agreements prohibit drug use, even if legal under state law. This Note examines recent caselaw to analyze how courts are handling the battle between state and federal government as it relates to cannabis legalization. Ultimately, the argument highlights the risk employees face – engaging in what they believe is legal behavior …

The Big Cost Of Small Farms, Tammi S. Etheridge

Scholarly Articles

Americans love meat. We celebrate our independence with steaks on the grill, we enjoy our favorite pastime with hot dogs, and we give thanks with turkey. Our love of meat is so ingrained in our culture that, historically, small increases in meat prices have driven the populace to riot. Today, meat prices are rising. Simultaneously, the largest meat processors and packagers are seeing record profits. Consumers, in turn, are outraged. Their emotions are being fueled by politicians who blame rising profits on a pandemic of greed and collusion and then argue that rigid antitrust enforcement is the only solution.

This …

The Grass Is Not Always Greener: How The Legalization Of Recreational Cannabis Across The United States Is At Odds With Incarceration And Continued Punishment, Marc Sendra

Washington and Lee Journal of Civil Rights and Social Justice

Whether you call it Mary Jane, skunky funky, green, ganja, reefer, or just plain-old cannabis, this special green plant doused in purple and orange accents has become a popular topic of discussion within the legal community and American culture. Cannabis has been held in “high” regard for its scientific advances in the medical industry, alongside its recreational usage, enjoyed by laughs and giggles, munchies, and plenty of water, leading to a wave of medical and recreational legalization.

Incentives for legalization come at the onset of promising medical research, economic growth motives, and social justice, reflecting upon a comprehensive approach that …

Food Price Narratives, Tammi S. Etheridge

Scholarly Articles

The use of antitrust in the context of food is problematic because it so clearly violates the Consumer Welfare Standard as prescribed by the courts. Ultimately, antitrust rhetoric promoting ad nauseam enforcement will not improve consumer welfare. Advancing consumer welfare in the food industry must mean prioritizing lower food prices over some arbitrary threshold of market competition or protecting small farms. Courts can and should begin distinguishing these goals immediately.

Fda Overreach: Is Your Pet’S Health A “Major Question” To You?, Ross C. Reggio

Washington and Lee Law Review

Pharmacy compounding of drugs for companion animals and humans is as old as time. For hundreds of years, pharmacists created these drugs using active pharmaceutical ingredients, otherwise known as bulk drug substances, to address the medical needs of these patients. Congress recognized this longstanding practice when it enacted the Food, Drug, and Cosmetic Act (“FDCA”), with lawmakers then noting that while pharmacists, physicians, and veterinarians were already highly regulated by the states, mass-producing drug manufacturers were not regulated. The FDCA would regulate such manufacturers.

Thereafter, pharmacy compounding from bulk drug substances continued for decades after the FDCA’s enactment and without …

Illegal Contracts And Agreements: A New Standard For Prostitution And Marijuana Agreements, Doug Rendleman

Washington and Lee Law Review

Agreements exchanging sex for money and those involving marijuana may encounter illegality defenses in court. Granting a legal remedy for breach of an agreement that exchanges seriously illegal consideration would lower the court’s public standing and endanger its legitimacy. On the other hand, the spectacle of a buyer claiming its own illegality to escape paying its seller troubles courts.

Lord Mansfield stated the illegality defense in Holman v. Johnson: “No Court will lend its aid to a man who founds his cause of action upon an immoral or an illegal act.” Yet he rejected the illegality defense in that case …

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 …

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 …

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 …

Disciplining Doctors: A Call For Caution When Responding To Physicians' Counter-Consensus Speech In The Time Of Covid-19, Timothy Macdonnell

Scholarly Articles

The COVID-19 pandemic affected nearly every aspect of life in the United States, including most notably, work-life, home-life, and community-life. During the pandemic, the government took extraordinary steps to try and reduce the spread of the disease by closing businesses, mandating the wearing of masks, and requiring vaccines. Government officials repeatedly justified their actions by stating that they were "following the science." However not all members of the scientific/medical community agreed with these actions. Some of these counter-consensus opinions were labeled mis/dis/mal/information.

As the COVID-19 pandemic dragged on, calls to punish doctors for COVID-19 misinformation increased. Some doctors who claimed …

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

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 …

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 …

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 …

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 …

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 …

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. …

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 …

Pediatric Off-Label Use Of Covid-19 Vaccines: Ethical And Legal Considerations, Elizabeth Lanphier, Shannon Fyfe

Scholarly Articles

After briefly contextualizing ethical and legal precedents regarding off-label use, we offer an analysis of the ethical permissibility of and considerations for pediatric off-label Covid-19 vaccination based on individual benefits, risks, and available alternatives. Our analysis challenges the ethics of the blanket prohibition against off-label pediatric Covid-19 vaccination in the VPA, as it blocks clinicians from providing the care they may determine to be clinically and ethically appropriate for their patient. At the same time, our analysis acknowledges that Covid-19 creates population-level ethical considerations that are at times in tension with individual health interests.

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

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

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 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.

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

Washington and Lee Law Review

No abstract provided.