Law Commons^™

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 …

Defending Henrietta Lacks: Justification Of Ownership Rights In Separated Human Body Parts, Arseny Shevelev, Georgy Shevelev

Vanderbilt Journal of Transnational Law

Since the time of Moore v. Regents of the University of California, it has become a well-established and widespread view that a person, when their separated body parts are misappropriated, is forced to limit themselves to fiduciary and other non-proprietary claims against those who violate the bodily inviolability of their separated parts. Now, with the filing of a lawsuit in defense of the rights in body parts of the victim of racial discrimination, Henrietta Lacks, the judicial system has an opportunity to justify itself by adopting a different perception of rights in human body parts. This Article focuses on the …

Envisioning The Ftc As A Facilitator Of Blockchain Technology Adoption In The Direct-To-Consumer Genetic Testing Industry, Noah Spector

Vanderbilt Journal of Entertainment & Technology Law

Seemingly overnight, the kingpins of the direct-to-consumer genetic testing (DTC-GT) industry shifted their focus from exploring their customers’ DNA to commodifying it. Companies like Ancestry or 23andMe that were once exclusively known as mere sources of “infotainment” now regularly sell consenting customers’ genetic data to pharmaceutical researchers or use it to develop drugs of their own. To gain these customers’ consent, both firms employ a series of long, complex clickwrap contracts that largely fail to apprise their readers of the potential risks of sharing their genetic data. Nor do these agreements provide any form of compensation to those consumers whose …

The Waiting Game: How States Can Solve The Organ-Donation Crisis, Meredith M. Havekost

Vanderbilt Law Review

Thousands of patients in the United States live in limbo every day waiting for a lifesaving organ transplant, and the gap between the number of people who need a transplant and the number of available organs widens every year. Every state currently allows individuals to unilaterally indicate their intent to donate their organs upon death, but in practice, family members are frequently allowed to override the express intentions of decedents. In addition, the current U.S. "opt-in" system fails to reach its full potential because many eligible decedents never express their desires to become or not to become organ donors, and …

A Taste Of Their Own Medicine: Examining The Admissibility Of Experts' Prior Malpractice Under The Federal Rules Of Evidence, Neil Henson

Vanderbilt Law Review

Medical malpractice litigation is challenging for both plaintiffs and defendants. The intersection of legal issues with complex medical theories creates a dispute focused on expert witnesses, which leads to greater litigation expenses and cumbersome legal proceedings.' As one scholar observed, "medical malpractice has proven to be ... an unpleasant quagmire of unending skirmishes and full-scale engagements spread across a shifting battlefield." That analogy is fitting considering the stakes of a medical malpractice case-the injured patient's emotional, physical, and financial well-being may be contingent on a successful outcome, while the doctor may perceive even the threat of litigation as detrimental to …

Instrumental And Transformative Medical Technology, Nicole Huberfeld Professor Of Law

Vanderbilt Journal of Entertainment & Technology Law

This Article considers how medical technologies impact universality in health care. The universality principle, as embodied in the Patient Protection and Affordable Care Act (ACA), eliminated widespread discriminatory practices and provided financial assistance to those otherwise unable to become insured--a democratizing federal act that was intended to stabilize health care policy nationwide. This Article posits that medical technology, as with all of medicine, can be universalizing or exclusionary and that this status roughly correlates to its being "instrumental technology" or "transformative technology." Instrumental technology acts as a tool of medicine and often serves an existing aspect of health care; in …

Preemption Of State Law Claims Involving Medical Devices: Why Increasing Liability For Manufacturers Is A Perilous But Pivotal Proposition, Neil M. Issar

Vanderbilt Journal of Entertainment & Technology Law

A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has widened over the past several years. The split encompasses both the circumstances under which the MDA implicitly preempts state law claims and the scope of the MDA's express preemption provision. Manufacturers of medical devices regulated by the Food and Drug Administration (FDA) enjoyed many years of favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction on monitoring or enforcement actions. However, the circuit split is reshaping the litigation landscape, and injured plaintiffs may rely on certain Circuit …

Uncovering The Silent Victims Of The American Medical Liability System, Joanna Shepherd

Vanderbilt Law Review

A frequently overlooked problem with the current medical liability system is the vast number of medical errors that go uncompensated. Although studies indicate that 1% of hospital patients are victims of medical negligence, fewer than 2% of these injured patients file claims. In this Article, I explain that many victims of medical malpractice do not file claims because they are unable to find attorneys willing to take their cases. I conducted the first national survey of attorneys to explore medical malpractice victims' access to the civil justice system. The results from the survey indicate that the economic reality of litigation …

Late Fathers' Later Children: Reconceiving The Limits Of Survivor's Benefits In Response To Death-Defying Reproductive Technology, Jeffrey W. Sheehan

Vanderbilt Journal of Entertainment & Technology Law

When Congress instructed the Social Security Administration to begin paying a social insurance benefit to "widows and orphans" in the 1930s, it simplified the process of determining an applicant's relationship to an insured decedent in two significant ways: First, Congress ordered the agency to honor the intestate laws of each state when determining whether an applicant was actually the child of a decedent, and second, it ordered the agency to treat any child who could qualify as an intestate heir as if that child actually depended on the parent financially at the time of the parent's death. Three-quarters of a …

Three And Out: The Nfl's Concussion Liability And How Players Can Tackle The Problem, Jeremy P. Gove

Vanderbilt Journal of Entertainment & Technology Law

In 1952, the New England Journal of Medicine published a study stating that a player should not continue playing professional football after suffering three concussions. As players continue to get bigger, faster, and stronger, the number of concussions has increased. In response to this problem, the National Football League (NFL) commissioned a study run by scientists and NFL team doctors to determine the long-term effects of concussions. That committee determined that no long-term repercussions exist after experiencing a concussion while playing NFL football. Despite the scientific community's critiques of the study, the NFL used the committee's findings to create the …

Electronic Medical Records: A Prescription For Increased Medical Malpractice Liability?, Blake Carter

Vanderbilt Journal of Entertainment & Technology Law

The cost and quality of health care is and most likely will continue to be one of the most important issues that the United States faces in the coming decade. Although no powerful antidote exists to cure this industry of all of its ailments, one potential suggestion to treat some of the symptoms is the introduction of electronic medical records (EMRs).

Members of the medical community, patients, and even politicians all agree that EMRs offer promising opportunities to improve the overall quality of health care. However, lost in the discussion of these opportunities, is a consideration of the potential side …

Over The Counter But Under The Radar: Direct-To-Consumer Genetics Tests And Fda Regulation Of Medical Devices, Lauren B. Solberg

Vanderbilt Journal of Entertainment & Technology Law

Direct-to-consumer genetic tests are laboratory-developed tests that are marketed and sold directly to consumers. They typically do not require a prescription or any other involvement from a consumer's health care provider. Consumers order these tests online and return a specimen, usually a saliva sample, directly to the laboratory. The results are mailed directly to the consumer, and no health care provider or insurance company need ever learn the contents of these results. The FDA does not currently regulate direct-to-consumer genetic tests, though tests for hundreds of different diseases are readily available to the public.

The FDA's approach to regulating genetic …

Tissue Tug-Of-War: A Comparison Of International And U.S. Perspectives On The Regulation Of Human Tissue Banks, Lisa C. Edwards

Vanderbilt Journal of Transnational Law

Every day in the United States and around the world, patients and research participants at hospitals and doctors' offices give biological samples, whether in the form of surgically removed cancer tissue or a routine blood sample. Many of these patients are entirely unaware that their tissues were not thrown out as hazardous waste, and instead used by scientists for the development of new drugs and therapies. The courts in the United States in Moore v. Regents of the University of California, Greenberg v. Miami Children's Hospital Research Institute, and most recently Washington University v. Catalona have determined that a patient …

Assessing The Market For Human Reproductive Tissue Alienability: Why Can We Sell Our Eggs But Not Our Livers?, Brenda Reddix-Smalls

Vanderbilt Journal of Entertainment & Technology Law

Currently, an unregulated marketplace for assisted reproductive technology exists in the United States. For some people suffering from infertility, the ability to purchase human reproductive tissue, eggs, and sperm yields a maximum benefit when examined in a market context. Buyers, sellers, supply and demand, and technological advances all operate in a robust marketplace to provide the infertile with a supply of human eggs for reproduction with minimum state and federal regulatory control. Conversely, the buying and selling of all other human organs and tissues is prohibited in the United States by several federal statutes. The National Organ Transplant Act (NOTA) …

Million Dollar Medical Malpractice Cases In Florida: Post-Verdict And Pre-Suit Settlements, Neil Vidmar, Kara Mackillop, Paul Lee

Vanderbilt Law Review

Beginning around the year 2000, the cost of medical liability insurance for doctors sharply increased, allegedly doubling in some specialties. As a result, medical malpractice litigation has once again occupied center stage in public debate about tort reform.' Large jury verdicts are cited by insurers, physicians, and defense attorneys as unwarranted and corruptive of the medical system because they set the bargaining rate around which plaintiff and defense lawyers negotiate settlements. One of the most commonly proposed remedies is a cap on the amount that can be awarded for general damages, often called "non-economic damages" or "pain and suffering," following …

Dishonest Medical Mistakes, Maxwell J. Mehlman

Vanderbilt Law Review

In the medical liability wars, physicians like to think that they are the ones in the trenches. Yet the true soldiers, of course, are the patients. As patients seek to avoid the barrage of malpractice reforms and the spoliation of managed care, one of their key refuges-the fiduciary duty of health care professionals-is being assailed from a number of directions. This Article describes these attacks and suggests how best to thwart them.

Imagine that you are seriously ill and go to a doctor. If you are like most patients these days, you are enrolled in some form of managed care. …

"Judicial Hellholes:" Medical Malpractice Claims, Verdicts And The "Doctor Exodus" In Illinois, Neil Vidmar, Russell M. Robinson Ii, Kara Mackillop

Vanderbilt Law Review

Beginning about the year 2000, physicians around the nation experienced an explosive jump in their professional medical liability insurance premiums. The state of Illinois has been identified as one of the "crisis" states by the American Medical Association ("AMA") insofar as cost and availability of liability insurance is concerned. Madison and St. Clair counties, just across the Mississippi River from St. Louis, have garnered particular attention, acquiring the label "judicial hellhole" for medical malpractice claims. The notoriety is so great that President Bush visited Madison County in January 2005 as part of his campaign for a nationwide $250,000 cap on …

Medical Malpractice Standard-Setting: Developing Malpractice "Safe Harbors" As A New Role For Qios?, James F. Blumstein

Vanderbilt Law Review

Concern about medical malpractice issues has reemerged, again stemming from escalating costs in some geographic regions and sectors of medical practice. The Bush Administration has (so far unsuccessfully) supported a cap on noneconomic loss as a strategy for coping with the cost aspects of those medical malpractice concerns, the model being the California approach.

Although the overall initiative for reform has considerable merit, the damage-cap has its opponents and its drawbacks. The damage-cap approach is remedy-centric, focusing on the scope of remedy as a vehicle for containing costs in the area of medical malpractice. By concentrating on remedies, the reform …

Medical Malpractice Litigation And Tort Reform: It's The Incentives, Stupid, David A. Hyman, Charles Silver

Vanderbilt Law Review

Health care providers and tort reformers invariably claim that the medical malpractice litigation system is rife with behaviors that are irrational, unpredictable, and counter-productive. They attack civil juries, asserting that verdicts are skyrocketing without reason, are highly variable, and bear little or no relation to the merits of plaintiffs' claims. They complain about patients, arguing that the few with valid claims sue rarely, while the many who receive non- negligent treatment sue all the time. They attack greedy lawyers, alleging that they rake in obscene profits by routinely filing frivolous complaints. They complain that compensation flows almost randomly, winding up …

Rethinking Peer Review: Detecting And Addressing Medical Malpractice Claims Risk, Ilene N. Moore, James W. Pichert, Gerald B. Hickson, Charles Federspiel, Jennifer U. Blackford

Vanderbilt Law Review

A medical center department chair has just been notified that a physician in his department, "Dr. G," is being sued for the fifth time in seven years. The CEO of co-defendant hospital wants the chair to solve Dr. G's "claims problems." At the chair's request, the hospital peer review committee evaluates Dr. G's malpractice cases. While committee members note some minor concerns in the cases, they conclude that in each circumstance he has met the standard of care. They cannot identify any specific technical or educational need, nor can they supply justification for a disciplinary action. The chair is in …

Bridging The Relational-Regulatory Gap: A Pragmatic Information Policy For Patient Safety And Medical Malpractice, William M. Sage, Joshua G. Zivin, Nathaniel B. Chase

Vanderbilt Law Review

The medical malpractice crisis of the last few years has tapped a lot of scholarly energy. Time not spent on original research-adding to the store of knowledge about the medical malpractice system-is often spent communicating with policymakers and the public. These experiences have led us to think a lot about the amount and quality of information circulating within or concerning the medical malpractice system, and about public policy reforms that would improve information flow in the future.

No grand theory has emerged from this meditation. Instead, we have formed definite, though not immutable, opinions about a desirable information policy for …

Putting The Caps On Caps: Reconciling The Goal Of Medical Malpractice Reform With The Twin Objectives Of Tort Law, Kyle Miller

Vanderbilt Law Review

Medical malpractice litigation is not a modern invention. Rather, it has been part of the American legal system since before the Revolution,1 and the most recent medical malpractice insurance crisis is not the first this country has known. However, losses to insurers during the earlier medical malpractice insurance crises pale in comparison to the ailments of this most recent crisis.2 Though this most recent medical malpractice insurance crisis seems to be coming to a close,3 by examining the causes of this crisis and enacting changes at present, this country may be able to avoid future crises. Of course, the first …

Duties To Subjects In Clinical Research, Carl H. Coleman

Vanderbilt Law Review

Physicians who conduct clinical research with human subjects face a profound conflict in professional roles. As physicians, they are committed to promoting the best interests of current patients. As researchers, however, their goal is to produce generalizable knowledge by studying the effects of interventions in broad cohorts of subjects.' Because producing generalizable knowledge often requires actions that are inconsistent with the best interests of the individuals enrolled in a study, these dual objectives often come into conflict. In such situations, where should the physician-researcher's loyalties lie? While this question has long been of interest to physicians and bioethicists, it has …

The Cloudy Crystal Ball: Genetics, Child Abuse, And The Perils Of Predicting Behavior, Robert D. Stone

Vanderbilt Law Review

In the cinematic world of Minority Report, mankind stands on the brink of a society without murder. Police can see the future, predicting murders and arresting perpetrators before they act. This utopian system is the ultimate evolution in preventative policing because it offers perfect prediction; it does not show what people intend to do, only what they will do. Society accepts the incarceration of pre-murderers, people who have committed no crimes, because there is no such thing as the "wrongfully accused.' Is the ability to predict behavior only science fiction, or can a combination of genetic and environmental factors actually …

Two Wrongs Don't Make A Right: Medicaid, Section 1983 And The Cost Of An Enforceable Right To Health Care, Mark A. Ison

Vanderbilt Law Review

More than a trillion dollars annually is spent on the health care system .... Despite increases in medical care spending that are greater than the rate of inflation, population growth, and Gross Domestic Product growth, there has not been a commensurate improvement in our health status as a nation .... Despite our Nation's wealth, the health care system does not provide coverage to all Americans who want it. These words capture both the essence of America's public health care dilemma and the frustration felt by many of the lawmakers charged with the duty to solve it. The battle to lower …

Fetal Surgery And Wrongful Death Actions On Behalf Of The Unborn: An Argument For A Social Standard, Jonathan D. Stanley

Vanderbilt Law Review

Imagine a young couple in the not-too-distant-future who are eagerly awaiting the birth of their first child. During the eighteenth week of the pregnancy, the mother has an ultrasound performed to detect possible developmental problems with the child. To their dismay, the ultrasound reveals a malformation in the fetus. The defect will not be fatal, but if left untreated will cause the child severe breathing problems once born. The problem can be fixed with surgery after birth, but such a procedure will result in disfiguring facial scars. After thoroughly considering their options, which range from an abortion to carrying the …

Just What The Doctor Ordered: The Admissibility Of Differential Diagnosis In Pharmaceutical Product Litigation, Wendy Michelle Ertmer

Vanderbilt Law Review

In the decade since Daubert v. Merrell Dow Pharmaceuticals Inc., federal judges have exercised their role as gatekeepers of expert witness testimony to evaluate many different categories of scientific evidence. They have not done so without controversy, however. Because the element of causation in pharmaceutical product litigation is frequently dispositive, the application of Daubert to scientific evidence of causation has been particularly contentious. Plaintiffs in such cases must prove both general causation-that the product is capable of causing an injury of the type from which the plaintiff suffers-and specific causation-that the product was the actual cause of the plaintiffs injury. …

Trial Rights And Psychotropic Drugs: The Case Against Administering Involuntary Medications To A Defendant During Trial, Dora W. Klein

Vanderbilt Law Review

The right of an accused in a criminal trial to due process is, in essence, the right to a fair opportunity to defend against the State's accusations. Those who have experienced the full thrust of the power of government when leveled against them know that the only protection the citizen has is in the requirement for a fair trial. [I]nvoluntary medication with antipsychotic drugs poses a serious threat to a defendant's right to a fair trial. On July 24, 1998, Russell Weston shot and killed two police officers, and wounded a third, near a security checkpoint in the United States …

Constitutional Issues Raised By States' Exclusion Of Fertility Drugs From Medicaid Coverage In Light Of Mandated Coverage Of Viagra, Erin L. Connolly

Vanderbilt Law Review

On July 2, 1998, officials at the Health Care Financing Administration ("HCFA"), the federal agency responsible for administering the Medicaid program,' mandated that state Medicaid pro- grams provide coverage for the impotency drug Viagra. The HCFA's announcement has proven very controversial, encountering resistance from many states who view the mandate as financially impairing their ability to provide other Medicaid services. Mandated Medicaid coverage of Viagra is also curious, considering that the Medicaid statute specifically permits states to exclude fertility drugs, a category of drugs into which Viagra falls, from coverage under state Medicaid programs. Moreover, most states do in fact …

Erisa Preemption Of Medical Malpractice Claims In Managed Care: Asserting A New Statutory Interpretation, Karla S. Bartholonew

Vanderbilt Law Review

Congress enacted the Employee Retirement Income Security Act of 1974 ("ERISA) to protect employee interests and ensure a uniform body of law for pension and benefit plans. The statute's expansive preemption clause and preclusion of extra-contractual damages have since been used to immunize Managed Care Organizations ("MCOs") from liability for patients injuries resulting from medical malpractice. Because plaintiffs with preempted claims may receive only the remedies provided for under ERISA-the right or benefit due under the plan-many injured patients have been left with no meaningful remedy.

"[N]ot a model of legislative drafting,"" the statute's broad preemption clause provides that state …