The FDA's regulatory framework for pharmaceuticals uses a "floor/ceiling" model: administrative rules set a "floor" of minimum safety, while state tort liability sets a "ceiling" of maximum protection. This model emphasizes pre-market scrutiny but largely relies on the state common law "ceiling" to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA's framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note argues that the FDA's administrative design misallocates the costs of the Opioid Epidemic and fails to adequately compensate those injured by it. Part I summarizes the FDA's regulatory framework with respect to opioid medications. Part II explains how that framework creates a compensatory problem that prevents the internalization of negative externalities by pharmaceutical manufacturers. Part III proposes a victims' compensation fund as the best substitute for the functions long performed by state tort liability.

Against the backdrop of escalating state efforts to decriminalize marijuana, U.S. Attorneys' Offices continue to bring drug-trafficking prosecutions against defendants carrying small amounts of marijuana that are permitted under state law. Federal district courts have repeatedly barred defendants from introducing evidence that they possessed this marijuana for their own personal use. This Note argues that district courts should not exclude three increasingly common kinds of "personal use evidence" under Federal Rules of Evidence 402 and 403 when that evidence is offered to negate intent to distribute marijuana. Three types of personal use evidence are discussed in this Note: (1) a defendant's possession of a state-issued medical marijuana license, (2) evidence that a state has legalized possession of marijuana for recreational purposes, and (3) evidence that a defendant suffers from a disease that marijuana arguably treats. Part I examines each of these three categories of personal use evidence and contends that district courts are likely to confront disputes over such evidence with increasing frequency. Part II analyzes objections to the admissibility of personal use evidence on direct examination, focusing primarily on Rules 402 and 403. Part III responds to those objections and argues that the evidence is probative of intent to distribute in federal marijuana-trafficking prosecutions.

Theories of parental alienation abound in high-conflict custody cases. The image of one parent brainwashing a child against the other parent fits with what we think we know about family dynamics during divorce. The concept of a diagnosable "Parental Alienation Syndrome" ("PAS") developed as an attempt to explain this phenomenon, but it has been widely discredited by mental health professionals and thus fails the standard for evidentiary admissibility. Nevertheless, PAS and related theories continue to influence the decisions of family courts, and even in jurisdictions that explicitly reject such theories, judges still face the daunting task of resolving these volatile cases. In the midst of this highly adversarial process, children deserve independent representation to ensure that their interests remain front and center. Mandating the appointment of guardians ad litem in cases involving allegations of abuse or alienation will assist courts in conducting individualized, fact-specific investigations into such allegations to craft custody orders that serve the best interests of children.

With the Patient Protection and Affordable Care Act ("ACA") set to dramatically increase access to medical care, the problem of rising costs will move center stage in health law and policy discussions. "Consumer directed health care" proposals, which provide patients with financial incentives to equate marginal costs and benefits of care at the point of treatment, demand more decisionmaking ability from consumers than is plausible due to bounded rationality. Proposals that seek to change the incentives of health care providers threaten to create conflicts of interest between doctors and patients. New approaches are desperately needed. This Article proposes a government-facilitated but market-based approach to improving efficiency in the private market for medical care that I call "relative value health insurance." This approach focuses on the "choice architecture" necessary to enable even boundedly rational patients to contract for an efficient level of health care services through their health insurance purchase decisions. It uses comparative effectiveness research, which the ACA funds at a significant level for the first time, to rate medical treatments on a scale of one to ten based on their relative value, taking into account expected costs and benefits. These relative value ratings would enable consumers to contract with insurers for different levels of medical care at different prices, reflecting different cost-quality trade-offs. The Article describes both the benefits of relative value health insurance and the impediments to its implementation. It concludes with a brief discussion of how relative value ratings could also help to rationalize expenditures on public health insurance programs.

Recent attempts to regulate Crisis Pregnancy Centers, pseudoclinics that surreptitiously aim to dissuade pregnant women from choosing abortion, have confronted the thorny problem of how to define commercial speech. The Supreme Court has offered three potential answers to this definitional quandary. This Note uses the Crisis Pregnancy Center cases to demonstrate that courts should use one of these solutions, the factor-based approach of Bolger v. Youngs Drugs Products Corp., to define commercial speech in the Crisis Pregnancy Center cases and elsewhere. In principle and in application, the Bolger factor-based approach succeeds in structuring commercial speech analysis at the margins of the doctrine.

A common condition of supervised release requires a defendant, post-incarceration, to participate in a mental health treatment program. Federal district courts often order probation officers to make certain decisions ancillary to these programs. However, Article III delegation doctrine places limits on such actions. This Note addresses the constitutionality of delegating the "treatment program" decision, in which a probation officer decides which type of treatment the defendant must undergo; the choice is often between inpatient treatment and other less restrictive alternatives. The resolution of this issue ultimately depends on whether this decision constitutes a "judicial act." Finding support in lower court case law, this Note argues that a "judicial act" encompasses decisions affecting the defendant's significant liberty interests. The Supreme Court case law and the mental health literature make clear that significant liberty interests are at stake in these "treatment program" decisions. Thus, delegating the "treatment program" decision to probation officers is unconstitutional under Article III. The Note concludes by suggesting a constitutionally permissible scheme whereby the judge orders a maximally intrusive treatment while giving the probation officer the discretion to choose a less restrictive program.

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining that the agreements reduce costs, increase innovation, and are reasonable based on the presumption of validity accorded to patents. Although scholars and the Federal Trade Commission have voiced strong arguments against courts' leniency, these have fallen on judicial deaf ears. In this Article, I apply the framework that the Supreme Court articulated in Verizon Communications v. Law Offices of Curtis V. Trinko, LLP, which underscored the importance in antitrust analysis of a regulatory regime addressing the challenged activity. In particular, the Hatch-Waxman Act provides Congress's views on innovation and competition in the drug industry, freeing courts from the thorny task of reconciling the patent and antitrust laws. Unfortunately, mechanisms that Congress employed to encourage patent challenges--such as an exclusivity period for the first generic to challenge validity--have been twisted into barriers preventing competition. Antitrust can play a central role in resuscitating the drafters' intentions and promoting competition. Given the Act's clear purpose to promote patent challenges, as well as the parties' aligned incentives and the severe anticompetitive potential of reverse payments, courts should treat such settlements as presumptively illegal. If the parties can demonstrate that the payments represent a reasonable assessment of litigation success, then they can rebut this presumption. If not, courts should conclude that the agreements violate the antitrust laws.

This Essay exposes and analyzes a hitherto overlooked cost of tort law: its adverse effect on innovation. Tort liability for negligence, defective products, and medical malpractice is determined by reference to custom. We demonstrate that courts' reliance on custom and conventional technologies as the benchmark of liability chills innovation and distorts its path. Specifically, recourse to custom taxes innovators and subsidizes replicators of conventional technologies. We explore the causes and consequences of this phenomenon and propose two possible ways to modify tort law in order to make it more welcoming to innovation.

Indoor tanning salons have grown significantly in popularity during recent years. Scientific research has revealed a strong link between skin cancer and ultraviolet light exposure from indoor tanning lamps. Despite such dangers, federal regulations place minimal restrictions on the labeling of indoor tanning lamps. Indoor tanning salons work vigorously to dispel notions of a link to skin cancer, often falsely promoting various health benefits of indoor tanning. The first lawsuit for injuries resulting from indoor tanning was recently filed against an indoor tanning salon, and other such litigation is poised to follow. This Note examines three potential tort claims against indoor tanning manufacturers and salons, and suggests ways to formulate compelling arguments in each instance. In doing so it draws on cases finding liability in the context of cigarettes, identifying similarities between the indoor tanning and cigarette industries.

Ten years down the road, what is the enduring significance of the "assisted suicide" cases, Washington v. Glucksberg and Vacco v. Quill? The cases reflect an unusually earnest, but nonetheless unsuccessful, attempt by the Supreme Court to grapple with a profound moral issue. So, why was the Court unable to provide a more satisfying justification for its conclusions? This Article, written for a symposium on the tenth anniversary of Glucksberg, discusses that question. Part I examines some of the flaws in reasoning in the Glucksberg and Quill opinions and suggests that these flaws stem from the opinion writers' inability to recognize and articulate their underlying normative assumptions. More specifically, both the Justices and the lower court judges, on both sides of the issue, evidently attributed normative significance to something like a "natural course of life" (even when they denied doing so), but none were willing or able to make this attribution explicit. Part II discusses the modern separation of moral reasoning from the metaphysical or theological perspectives that might once have endowed "nature" with normative significance, and it suggests that the deficiencies in Glucksberg-Quill are evidence of how that separation renders moral reasoning problematic. The Conclusion wonders whether in this situation, a renewed emphasis on formalism or tradition might make legal reasoning less unacceptable.

It has now been ten years since the Supreme Court handed down Glucksberg and Quill, rulings on laws that forbid "assisted suicide." In that time, normative and legal developments in the fields of law, medicine, and psychology have changed the landscape of the discourse on the choice of a mentally competent, terminally ill individual to choose to self-administer medications to bring about a peaceful death. Although the Court rejected petitioners' claims that state laws denying them the ability to end their terminal illnesses through self-administered medication violated the Constitution, it left states with the opportunity to experiment with legislation that would allow terminally ill individuals the choices they had previously sought through litigation. Oregon's experience with its Death with Dignity Act, which grants terminally ill, mentally competent individuals the choice to end their lives through self-administered medication, has proven that such laws provide comfort not only to those who, faced with the prospect of a horrible death from a terminal illness, choose to end their lives in a peaceful and dignified manner, but also to those to ultimately choose not to. Additionally, Oregon's experience shows that the fears that originally attended the "assisted suicide" debate are unfounded so long as proper procedures are in place. Because Oregon's Death with Dignity Act has proven both useful and harmless, this Article concludes that it is time for other states to follow Oregon's lead and enact their own legislation to allow their citizens an alternative to what otherwise could be a prolonged and painful death from terminal illness.

This Article critiques conventional liberal arguments for the right to die on liberal grounds. It contends that these arguments do not go far enough to recognize and address private, and in particular structural, forms of domination. It presents an alternative that does, which is thus more respectful of true freedom in the context of death and dying, and also more consistent with liberalism. After discussing obstacles to the achievement of a right to die that encompasses freedom from both public and private domination, the Article closes with a significant reform project within bioethics that might help bring it about.

This Article examines the Oregon Death with Dignity Act from a medical perspective. Drawing on case studies and information provided by doctors, families, and other care givers, it finds that seemingly reasonable safeguards for the care and protection of terminally ill patients written into the Oregon law are being circumvented. The problem lies primarily with the Oregon Public Health Division ("OPHD"), which is charged with monitoring the law. OPHD does not collect the information it would need to effectively monitor the law and in its actions and publications acts as the defender of the law rather than as the protector of the welfare of terminally ill patients. We make explicit suggestions for what OPHD would need to do to change that.

The Family and Medical Leave Act ("FMLA") recognizes an employee's right to take leave to care for a qualifying family member. In light of the Act's remedial nature, the intended scope of the care provision is broad, but its definitional details are sparse. As a result of the attendant interpretive discretion afforded to courts, the Seventh Circuit announced its rejection of the requirement-- first articulated by the Ninth Circuit--that care provided during travel be related to continuing medical treatment. A facial analysis of the resulting circuit split fails to appreciate the fundamental difference between the Seventh and Ninth Circuits' considerations: the distinction between physical and psychological care. Whereas physical care is readily measurable, psychological care is less defined and, consequently, ripe to facilitate FMLA abuse. Efforts to combat this potential lead courts to impose judicially devised limitations on psychological care, but judicial discretion still infuses some uncertainty into proceedings. For employers, the best remedy lies in the FMLA's optional certification provision, which requires medical validation of an employee’s need for leave. In requiring certification, employers should distinguish between physical and psychological care, maximize the FMLA’s informational requirements, and implement complete and consistent request and approval procedures.

Numerous states have recently legalized recreational marijuana, which has created a burgeoning marijuana industry needing and demanding access to a variety of banking and financial services. Due, however, to the interplay between the federal criminalization of marijuana and federal anti-money laundering laws, U.S. financial institutions cannot handle legally the proceeds from marijuana activity. As a result, most financial institutions are unwilling to flout federal anti-money laundering laws, and so too few marijuana-related businesses can access banking services. This Note argues that the most viable policy option for resolving this "underbanking" problem is a financial cooperative approach such as a cannabis-only financial cooperative. Even in light of federal anti-money laundering laws, this Note contends that the Federal Reserve is legally authorized to grant some cannabis-only financial cooperatives access to its payment system services under the Monetary Control Act of 1980.

The debate over how to tame private medical spending tends to pit advocates of government-provided insurance--a single-payer scheme--against those who would prefer to harness market forces to hold down costs. When it is mentioned at all, the possibility of regulating the medical industry as a public utility is brusquely dismissed as anathema to the American regulatory tradition. This dismissiveness, however, rests on a failure to appreciate just how deeply the public utility model shaped health law in the twentieth century-- and how it continues to shape health law today. Closer economic regulation of the medical industry may or may not be prudent, but it is by no means incompatible with our governing institutions and political culture. Indeed, the durability of such regulation suggests that the modern embrace of market-based approaches in the medical industry may be more ephemeral than it seems.

Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created several statutory forfeiture provisions that proved only marginally effective at curbing the practice of exclusivity parking. More recently, Congress created new quasi-judicial administrative proceedings that effectively replace certain kinds of district court patent litigation. This Note describes the complex statutory scheme that gave rise to exclusivity parking, explains why previous and current attempts to curtail exclusivity parking were and remain ineffective, and suggests amending the "failure to market" provision to include these new administrative proceedings as a way to help curb exclusivity parking.

Over the past century, the allegation that the tort liability system incentivizes legal extortion and is chock-full of fraudulent claims has dominated public discussion and prompted lawmakers to ever-more-creatively curtail individuals' incentives and opportunities to seek redress. Unsatisfied with these conventional efforts, in recent years, at least a dozen corporate defendants have "discovered" a new fraud-fighting tool. They've started filing retaliatory RICO suits against plaintiffs and their lawyers and experts, alleging that the initiation of certain nonmeritorious litigation constitutes racketeering activity—while tort reform advocates have applauded these efforts and exhorted more "courageous" companies to follow suit. Curiously, though, all of this has taken place against a virtual empirical void. Is the tort liability system actually brimming with fraudulent claims? No one knows. There has been no serious attempt to analyze when, how often, or under what conditions fraudulent claiming proliferates. Similarly, tort reformers support RICO's use because, they say, conventional mechanisms to deter fraud fall short. But are conventional mechanisms insufficient? Hard to say, as there is no comprehensive inventory of the myriad formal and informal mechanisms already in use; nor do we have even a vague sense of how those mechanisms actually operate. Further, though courts have started to green-light retaliatory RICO actions, no one has carefully analyzed whether these suits are, on balance, beneficial. Indeed, few have so much as surfaced relevant risks. Addressing these questions, this Article attempts to bring overdue attention to a problem central to the tort system’s operation and integrity.

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they lack both expertise and proprietary information. How should we ensure that medical algorithms are safe and effective? Medical algorithms need regulatory oversight, but that oversight must be appropriately tailored. Unfortunately, the Food and Drug Administration (FDA) has suggested that it will regulate algorithms under its traditional framework, a relatively rigid system that is likely to stifle innovation and to block the development of more flexible, current algorithms. This Article draws upon ideas from the new governance movement to suggest a different path. FDA should pursue a more adaptive regulatory approach with requirements that developers disclose information underlying their algorithms. Disclosure would allow FDA oversight to be supplemented with evaluation by providers, hospitals, and insurers. This collaborative approach would supplement the agency's review with ongoing real-world feedback from sophisticated market actors. Medical algorithms have tremendous potential, but ensuring that such potential is developed in high-quality ways demands a careful balancing between public and private oversight, and a role for FDA that mediates--but does not dominate--the rapidly developing industry.

Since the early 1990s, jurisdictions around the country have been using civil child abuse laws to penalize women for using illicit drugs during their pregnancies. Using civil child abuse laws in this way infringes on pregnant women's civil rights and deters them from seeking prenatal care. Child Protective Services agencies are key players in this system. Women often become entangled with the Child Protective Services system through their health care providers. Providers will drug test pregnant women without first alerting them to the potential negative consequences stemming from a positive drug test. Doing so is a breach of these providers' duties to obtain informed consent from their patients before administering medical tests. Malpractice liability can deter providers from forcing women into the Child Protective Services system and forestall the use of civil child protective laws to criminalize pregnancy.