Law Commons^™

Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka

Vanderbilt Law Review

When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not …

Too Stubborn To Care For: The Impacts Of Discrimination On Patient Noncompliance, Alice Abrokwa

Vanderbilt Law Review

The role of implicit racial biases in police interactions with people of color has garnered increased public attention and scholarly examination over time, but implicit racial bias in the healthcare context can be as deadly, particularly when it intersects with ableism and sexism. Researchers have found that medical providers are more likely to consider Black patients “noncompliant,” meaning the patient has not adhered to recommended treatment, even without evidence Black patients are less compliant than other patients. Being labeled noncompliant can have grave health consequences; providers are less likely to treat pain aggressively when they consider a patient noncompliant and, …

Mixed-Up Origins: The Case For A Gestational Presumption In Embryo Mix-Ups, Betsy A. Sugar (J.D. Candidate)

Vanderbilt Law Review

Embryo mix-ups-instances in which fertility clinics mistakenly implant one couple with another couple's embryo confound courts' determinations of who, between the two couples, are the legal parents. Lax regulation of the fertility industry permitted this relatively new injury to develop, and it has led to morally and legally fraught questions of parenthood and personal autonomy. This Note reviews parentage doctrines, beginning with a discussion of the martial presumption; it also tracks how courts have traditionally responded to parentage questions that fertility medicine has generated, including embryo division in divorce and parentage in surrogacy contracts. It then analyzes potential approaches to …

Call Me, Beep Me, If You Want To Reach Me: Utilizing Telemedicine To Expand Abortion Access, Samantha A. Hunt

Vanderbilt Law Review

In June 2022, the Supreme Court handed down its decision in Dobbs v. Jackson Women’s Health Organization. The decision confirmed what the public already knew. An anonymously leaked draft version of what ultimately became Justice Samuel Alito’s majority opinion had braced the country for Dobbs’s keyholding. Overturning decades of precedent, the Court found that there is no right to abortion in the United States Constitution. Shortly thereafter, states began implementing restrictions and near-total bans on abortion. These laws had an immediate effect on the safety of pregnant people. In Tennessee, a state where abortion is now outlawed, one woman had …

Abortion, Pregnancy Loss, & Subjective Fetal Personhood, Greer Donley, Jill Wieber Lens

Vanderbilt Law Review

Long-standing dogma dictates that recognizing pregnancy loss threatens abortion rights-—acknowledging that miscarriage and stillbirthinvolve the loss of something valuable, the theory goes, creates a slippery slope to fetal personhood. For decades, antiabortion advocates have capitalized on this tension and weaponized the grief that can accompany pregnancy loss in their efforts to legislate fetal personhood and end abortion rights. In response, abortion rights advocates have at times fought legislative efforts to support those experiencing pregnancy loss and, more recently, remained silent, alienating those who suffer a miscarriage or stillbirth.

This Article argues that this perceived tension can be reconciled through the …

Make Hay While The Sun Shines: Private Equity And The False Claims Act, Gregory F. Maczko

Vanderbilt Law Review

For years, the federal government has used the False Claims Act to police fraud in the healthcare industry. Every year, the Department of Justice recovers billions of dollars from healthcare companies for their False Claims Act violations, both penalizing wrongdoers and providing incentives for whistleblowers to come forward. Over the past decade, however, private equity activity within the healthcare industry has increased significantly, presenting questions as to how the False Claims Act applies when a private equity firm’s portfolio company is accused of wrongdoing. This Note analyzes the ambiguity in how different courts have previously applied the False Claims Act …

Neuronal Testimonial: Brain-Computer Interfaces And The Law, Jessica L. Haushalter

Vanderbilt Law Review

Scientific researchers have developed a method of using brainscanning technology to determine if patients in a coma-like condition, known as a "vegetative state," are conscious despite their inability to communicate verbally or via motor actions. While in a brain scanner, patients "answer" yes-or-no questions by envisioning specific scenarios that activate different parts of the brain. A researcher interprets a brain scan image as a yes-or-no response based on which areas of the brain demonstrated activation. Exciting as this technology may be, there are difficulties in terms of the ability to use it within the legal system. This Note considers those …

Restore, Revert, Repeat: Examining The Decompensation Cycle And The Due Process Limitations On The Treatment Of Incompetent Defendants, Margaret W. Smith

Vanderbilt Law Review

Though correctional facilities are one of the largest providers of mental health care in the country, the treatment provided often fails to address the needs of many mentally ill inmates. Indeed, after receiving treatment at a state mental health facility, many pretrial detainees who have been recently restored to competency revert to an incompetent state-or decompensate-upon their return to jail, at which point they must return to the state treatment facility to be restored to competency once again. This Note is the first to explore this "decompensation cycle," highlighting the significance of the problem and demonstrating how mental health treatment …

Reading Remedially: What Does "King V. Burwell" Teach Us About Modern Statutory Interpretation, And Can It Help Solve The Problems Of Cercla § 113(H)?, Benjamin Raker

Vanderbilt Law Review

In the latter half of the twentieth century, Congress drafted a law to solve a problem. As decades passed, that problem became increasingly complex. In the new millennium, Congress became increasingly polarized, and increasingly unproductive. In the face of that inaction, the executive branch decided to rely on a provision of that earlier law to address a modern facet of that earlier problem. Or litigants decided to ask a court to rely on a provision of that earlier law to address a modern facet of that earlier problem. The Congress that drafted the law might not have understood this modern …

No Vip Treatment: Acos Should Not Get Waiver Protection From The Prohibition On Beneficiary Inducement, Soraya Ghebleh

Vanderbilt Law Review

Virgil is known for saying "the greatest wealth is health."' Based on the astronomical amount spent on healthcare, the United States has taken his idea literally-spending more "wealth" will lead to greater "health." In 2006, the United States spent over seven thousand dollars per person annually on healthcare. While that number may not seem very high to spend on an individual level, the total amounted to approximately 2.1 trillion dollars in 2006. In 2014, that number hit three trillion, or seventeen percent of the country's Gross Domestic Product ("GDP"). One justification for spending nearly one-fifth of the United States GDP …

A Gap In The Affordable Care Act: Will Tax Credits Be Available For Insurance Purchased Through Federal Exchanges?, Amy E. Sanders

Vanderbilt Law Review

Millions of Americans rest assured that the Patient Protection and Affordable Care Act' ("ACA") provides tax credits for health insurance to individuals earning 100-400% of the federal poverty line. The tax credits will be accessible through state insurance exchanges, also known as Marketplaces, which are government- regulated organizations designed to create more competition in the health insurance industry. But a gap in the unwieldy, two-thousand- plus-page statute-either a scrivener's error or an overlooked loophole-is raising questions about whether citizens in certain states are eligible for the tax credits. This "quirk" could be a serious blow to an already contentious healthcare-reform …

Causing Infringement, Mark Bartholomew, Patrick F. Mcardle

Vanderbilt Law Review

In its most recent contributory infringement pronouncement, the Supreme Court advised courts wrestling with these issues to consult tort law's own contributory liability framework, which it described as "well established."31 The conventional wisdom among legal scholars agrees with the Court. Most scholarship in this area contends that obeisance to traditional tort law principles of contributory liability will fill the void in infringement law with answers that are adequately calibrated to the balance between incentivizing creation and permitting downstream use. This Article challenges that conventional wisdom. Although we agree that tort law can shed some much-needed light on contributory infringement, we …

Big Tobacco, Medicaid-Covered Smokers, And The Substance Of The Master Settlement Agreement, Gregory W. Traylor

Vanderbilt Law Review

In 1994, executives from "Big Tobacco"-industry leaders Philip Morris, R.J. Reynolds, Brown and Williamson Tobacco, and Lorillard-appeared before Congress and denied that nicotine is addictive despite internal documents disclosing a long history of industry-wide awareness about the addictive nature of the drug. One executive even denied that smoking causes death despite the well- established scientific consensus to the contrary. Worse still, tobacco companies had consciously targeted children as young as fourteen-years-old in their advertising schemes. In an internal R.J. Reynolds memorandum to Vice President of Marketing C.A. Tucker, J.F. Hind wrote: "To ensure increased and longer-term growth for CAMEL FILTER, …

On The Limits Of Supremacy: Medical Marijuana And The States' Overlooked Power To Legalize Federal Crime, Robert A. Mikos

Vanderbilt Law Review

Using the conflict over medical marijuana as a timely case study, this Article explores the overlooked and underappreciated power of states to legalize conduct Congress bans. Though Congress has banned marijuana outright, and though that ban has survived constitutional scrutiny, state laws legalizing medical use of marijuana not only survive careful preemption analysis, they constitute the de facto governing law in thirteen states. This Article argues that these state laws and most related regulations have not been and, more interestingly, cannot be preempted by Congress, given constraints imposed on Congress's preemption power by the anti-commandeering rule, properly understood. The Article …

The Circle Of Assent: How "Agreement" Can Save Mandatory Arbitration In Long-Term Care Contracts, Lauren Gaffney

Vanderbilt Law Review

On September 28, 1997, a resident at the Comanche Trail Nursing Center physically attacked his eighty-one-year-old roommate, Tranquilino Mendoza. As a result of the attack, Mr. Mendoza suffered a concussion and brain damage. His daughter claimed that her father was never the same after the attack and filed a lawsuit against the long-term care facility alleging negligence. In 2006, a jury awarded Mr. Mendoza $160 million.

Similarly, on April 26, 2003, a resident of the Heritage House Nursing and Rehabilitation Center allegedly attacked Carolyn Mason, another resident at the same facility. Mrs. Mason suffered a broken hip.6 Like Mr. Mendoza, …

The Search For Due Process In Civil Commitment Hearings: How Procedural Realities Have Altered Substantive Standards, Christyne E. Ferris

Vanderbilt Law Review

The civil commitment of mentally ill individuals presents the legal system with an intractable question: When should the law deprive someone of the fundamental right to liberty based on a prediction of future dangerousness? Advocates of both increased and decreased levels of civil commitment offer compelling case studies to help resolve the question. The former point to high profile events like the Virginia Tech shooting, in which mandatory incapacitation of the perpetrator at the first sign of mental illness could have prevented a senseless tragedy. The latter highlight the lives of individuals like Kenneth Donaldson, whose father had him committed …

Reformulating Outrage: A Critical Analysis Of The Problematic Tort Of Iied, Russell Fraker

Vanderbilt Law Review

The intentional infliction of emotional distress ("IIED"), also known as the tort of outrage, is a relatively new cause of action, first appearing in the legal academic literature during the 1930s. Since that time, IIED has gained widespread acceptance and is now recognized in all U.S. jurisdictions, with most courts invoking the definition set forth in the Restatement (Second) of Torts. Despite this general acceptance of the tort, courts routinely assert that IIED is a disfavored cause of action. Courts appear wary of holding defendants liable for plaintiffs' emotional injuries and therefore seek to discourage such claims.

In their efforts …

Plaintiffs' Lawyers, Specialization, And Medical Malpractice, Stephen Daniels, Joanne Martin

Vanderbilt Law Review

Our interest is in medical malpractice as an area of specialized practice for plaintiffs' lawyers, and we want to explore this area because plaintiffs' lawyers are key actors in the medical malpractice system. An understanding of their role is necessary in identifying what problems may exist in this system and in evaluating both proposed and enacted solutions. Indeed, some reforms appear to be specifically aimed at plaintiffs' lawyers who handle medical malpractice cases-especially the repeat players whose experience and expertise may give them, and hence their clients, a strategic advantage.

Like most of the political rhetoric surrounding medical malpractice, the …

High-Deductible Health Plans: New Twists On Old Challenges From Tort And Contract, E. Haavi Morreim Ph.D.

Vanderbilt Law Review

In just a few decades American health care financing has, in a sense, come full circle. After being largely patient-financed in the early twentieth century, generous insurance coverage in mid-century largely permitted providers to do as they wished and charge what they pleased-an Artesian Well of Money that left patients and physicians well-insulated from the costs of care. That system's inevitable explosion of costs spurred urgent efforts to contain health care expenditures, as payors sought to control or at least influence medical decisions. In many ways this "managed care" was clinically vexatious and economically disappointing. Its medically intrusive tactics have …

Hmos Behind Bars: Constitutional Implications Of Managed Health Care In The Prison System, Richard Siever

Vanderbilt Law Review

In 1991, the Correctional Corporation of America (CCA) entered into a contract with the State of Tennessee to house and treat state prisoners at CCA facilities. In response to increased costs, CCA negotiated a contract with a physician to be the exclusive provider of medical services for one of its facilities. Essentially, this contract formed a managed health care system: the doctor's payment structure included a base salary, but it also incorporated financial incentives that could increase his overall compensation if he were to provide less care to inmates.

Later, Anthony Bowman, a prison inmate with sickle cell anemia, died …

Can't We All Just Get Along?: The Treatment Of "Interacting With Others" As A Major Life Activity In The Americans With Disabilities Act, Mark Deloach

Vanderbilt Law Review

The Americans with Disabilities Act (ADA) was passed in 1990 with the stated goal of providing a "clear and comprehensive national mandate for the elimination of discrimination against individuals with disabilities." Congress determined that, at the time of the passage of the Act, approximately forty-three million Americans had mental or physical disabilities. By enacting the ADA, Congress meant to "provide clear, strong, consistent, enforceable standards addressing discrimination against individuals with disabilities." Now, fourteen years after the ADA's enactment, the success of these goals is in doubt. A 1998 survey of cases brought under Title I of the ADA indicated that …

Pressing Precaution Beyond The Point Of Cost-Justification, Gregory C. Keating

Vanderbilt Law Review

Years ago, Bruce Ackerman contrasted two competing perspectives on law, that of the "ordinary observer" and that of the "scientific policymaker."' The perceptions and discourse of the "ordinary observer," Ackerman explained, start from the common practices and language of laymen. The "scientific policymaker" takes the realization of particular objectives-efficient precaution against risks of accidental injury and death, for example-as her end and uses the law as an instrument toward that end. Clashes between these two perspectives are endemic to our legal culture. Nowhere in the law of accidents is that conflict sharper than in cases where the risks imposed threaten …

Assisting Minors Seeking Abortions In Judicial Bypass Proceedings: A Guardian Ad Litem Is No Substitute For An Attorney, Elizabeth S. Graybill

Vanderbilt Law Review

Since the 1973 decision in Roe v. Wade,' minors have been particularly affected by the efforts of pro-life activists and state legislatures who have curtailed abortion rights by lobbying for and passing legislation that restricts reproductive freedom. Forty-three states have enacted laws requiring a minor either to obtain consent from or to notify one or both parents before undergoing an abortion, and thirty-three of these statutes are currently enforceable. The Supreme Court has recognized the right of parents to be involved in a child's upbringing and the prerogative of the state to limit a minor's freedom to make major life …

Protecting Health Information Privacy: The Case For Self-Regulation Of Electronically Held Medical Records, Catherine L. Glenn

Vanderbilt Law Review

Advances in technology have given new life to debates concerning privacy.' Specifically, issues surrounding increased access to personal medical records have recently garnered attention. On one side of the debate, healthcare providers and insurers support expanded access to medical records for treatment, research, and insurance claims purposes. At the same time, however, many patients legitimately expect their medical records to remain private. The advent of Internet access to patient records and electronic medical insurance claims submissions has heightened patients' concerns that computerized medical records will offer less protection and more potential for unauthorized disclosure than paper files in locked cabinets. …

Health Care Reform Through Medicaid Managed Care: Tennessee (Tenncare) As A Case Study And A Paradigm, James F. Blumstein, Frank A. Sloan

Vanderbilt Law Review

TennCare is a Medicaid demonstration project that allows Tennessee to require all Medicaid beneficiaries to secure medical care through a mandatory managed care system. Enrollees contract with private managed care organizations ("MCOs'), which are responsible for organizing a network of care providers and delivering medical care to covered beneficiaries. Driven by rapidly escalating Medicaid costs, TennCare's mandatory managed care program has succeeded in saving money for the state in its Medicaid program. To secure the federal waiver that allowed the program to proceed, the state included non-Medicaid-eligible uninsured and uninsurable residents as TennCare beneficiaries. Federal matching funds accrue for all …

Disabled Former Employees Under The Ada: Unprincipled Decisions And Unpalatable Results, Austin L. Mcmullen

Vanderbilt Law Review

A number of disabled former employees have turned to the Americans with Disabilities Act ("ADA") to redress alleged discrimination in their termination or in the benefit plans of their former employers.' Several courts, however, have held that these plaintiffs are not "qualified individual[s] with a disability," and, therefore, may not recover under the ADA. Other courts of appeals have recently found the ADA's proscription of discrimination in the "terms, conditions, and privileges of employment" to contradict the definition of qualified individuals. These courts resolved the ambiguity by allowing disabled former employees a federal right to sue their former employers for …

Primum Non Nocere: The Expanding "Honest Services" Mail Fraud Statute And The Physician-Patient Fiduciary Relationship, Gregory D. Jones

Vanderbilt Law Review

In one case, a physician refers a patient to a certain hospital in return for an undisclosed referral fee from the hospital. In another, a physician decides not to refer a patient to a specialist for further examination. The physician, however, does not disclose to the patient that part of the cost of sending the patient to the specialist would come out of the physician's potential earnings. In the previous examples, has the physician breached her fiduciary duty to the patient by not disclosing her own financial interest in the patient's treatment? If so, the physician could be guilty of …

Toward A Fair And Practical Definition Of "Willfully" In The Medicare/Medicaid Anti-Kickback Statute, Tamsen D. Love

Vanderbilt Law Review

Health care fraud takes on a variety of forms-from billing insurance companies for services not provided, to falsifying injuries for tort plaintiffs, to practicing medicine without a license.' All these types of fraud contribute to the astronomical cost of health care in the United States. As federal policymakers have focused on ways to contain these costs, health care fraud has become an increasing object of scrutiny. At the same time, the health care industry is experiencing significant institutional change, particularly with the emergence of health maintenance organizations ("HMOs") and other managed care systems. The Medicare/Medicaid anti-kickback statute, which prohibits payments …

Introduction: Current Issues In Mental Health Care - Special Edition, Tamsen D. Love

Vanderbilt Law Review

Today we think we know a lot more about mental health care than our country's founders did. Yet in many ways we are in no better position than our eighteenth-century predecessors. Certainly, the decisions we as a society face about mental illness are just as difficult. The vocabulary we employ is more complex--"behavioral health organization," "psychopharmacology," "cost containment"--but the issues are the same: Who should pay for mental health care? How much care is appropriate? And, more fundamentally, what exactly is mental health?

This year's Special Project addresses these issues. The Notes focus on particular legal issues in the mental …

The Early And Periodic Screening, Diagnostic, And Treatment Program And Managed Medicaid Mental Health Care: The Need To Reevaluate The Epsdt In The Managed Care Era, John A. Flippen

Vanderbilt Law Review

For a majority of Medicaid recipients, managed health care is fast becoming a reality. As state governments seek to control Medicaid costs in a world of limited resources, unlimited reimbursement for any treatment a doctor deems necessary is no longer feasible. One major tool for cost containment has been the privatization of the delivery of Medicaid coverage into managed care organizations. The shift to a managed plan means that services will be rationed. This rationing occurs because capitated rates, for example, require that private managed care organizations ("MCOs") bear the risk of providing services to the Medicaid population and attempt …