Health Law

Max Selver

The prevailing medical consensus is that drug addiction and alcoholism are disabilities. Before 1996, SSI and SSDI, the nation’s major disability benefits programs, recognized that consensus and provided benefits to people struggling with addiction. Then, the “DAA materiality” provision of Congress’s 1996 welfare reform legislation revoked eligibility not only from people struggling with addiction, but also from people with addiction and another severe disability whose addiction contributes to the severity of the other disability. For this latter group of “dual-diagnosis” claimants, it is often impossible to determine which of a claimant’s impairments would remain absent substance abuse. In such cases, the evidence is in equipoise, and whichever party bears the burden of proof of DAA materiality will lose. Despite its importance to many disability benefits claimants, the issue of who bears the burden of proof remains unresolved, with the Social Security Administration placing the burden on the government and a split among the federal appeals courts that have taken up the issue. This Note argues that the burden of proof of DAA materiality should fall on the government. It shows that the DAA materiality provision creates an exception to the definition of disability in the Social Security Act that functions like an affirmative defense for the government to deny benefits to otherwise eligible claimants. It then contrasts the many obstacles facing dual-diagnosis claimants with the government’s superior resources and expertise to offer proof on the complex DAA materiality issue.

Mitchell Russell Stern

Thanks to a streamlined approval process under the 1984 Hatch-Waxman Act, generic drugs have largely helped make prescription medications in the United States more affordable by providing an essentially identical product at a lower price. While generics may appear to be a perfect substitute for brand-name pharmaceuticals, consumers injured by prescription drugs may encounter an unexpected difference: because federal regulations severely restrict the ability of generic manufacturers to unilaterally update their warning labels, the Supreme Court has held that many products liability claims against generic manufacturers are pre-empted. At the same time, the Court has held that identical claims against brand name manufacturers remain viable. In response, the Federal Food and Drug Administration (FDA) has recently proposed a rule that would purportedly “fix” this asymmetry by allowing generic manufacturers to make labeling changes without prior FDA approval, even if it results in a brand-name drug and its generic “equivalent” bearing different warning labels.

This Note argues that the FDA’s response, while well intentioned, loses the forest for the trees by overvaluing compensation for injured consumers at the expense of low-cost generic drugs and accurate, consistent information for consumers. Instead, both the Agency and consumers injured by generic drugs should focus on discrepancies that already exist—that violate FDA regulations—between generic and brand name labels. Such cases not only present an information problem that should be corrected, but they may also provide a viable avenue for litigating products liability claims. While there is currently a circuit split on the issue, this Note explains why these failure-to-update claims should not be preempted. Moreover, given that such differences may occur in a majority of generic drug labels, these claims offer the possibility of recovery for a significant number of consumers.

Gabriel Ascher

The Affordable Care Act requires coverage for female but not male sterilization, a disparity that this Note refers to as the Sterilization Gap. Although female sterilization is more dangerous, more expensive, and less effective than male sterilization, the Sterilization Gap incentivizes women to be sterilized rather than men. This Note argues that sterilization coverage should be extended to men. Because courts are empowered to extend underinclusive laws—like that which creates the Sterilization Gap—if they find them unconstitutional, litigation may be the best method of extending coverage. This Note presents a comprehensive argument for why the Sterilization Gap is unconstitutional and coverage should be extended. First, it argues that the Sterilization Gap is a facial sex classification because both sexes can be sterilized, even though the procedure is sex specific. Next, it argues that the classification violates constitutional equal protection law, because it is not based on a biological difference and does not remedy discrimination against women. Then, it argues that the classification was created either through impermissible oversight or gender stereotypes, and that it will perpetuate the stereotype that contraception is a woman’s responsibility, to the detriment of both sexes. Finally, it concludes by asserting that had Congress known that the Sterilization Gap was unconstitutional, it would likely have chosen to extend coverage to men rather than nullify the law, because extension would further its goals while causing comparatively little disruption to the statutory scheme.

Shaun E. Werbelow

Accountable Care Organizations (ACOs), a major component of the Affordable Care Act, seek to provide patients with better quality health care at a lower cost and have been praised for their ability to help repair our country’s broken health care system. Despite their potential benefits, however, ACOs also raise significant antitrust concerns—concerns that may pit consumer surplus and total surplus against one another. In an attempt to address these concerns, the Department of Justice and Fair Trade Commission announced that they will use market share screens and rule of reason treatment to evaluate ACOs participating in the Medicare Shared Savings Program. The use of market share screens and rule of reason treatment allows the antitrust agencies to avoid prioritizing either consumer surplus or total surplus in the first instance but leaves open two critical questions: What will the rule of reason treatment afforded to ACOs look like? And how will the antitrust agencies ultimately determine whether ACOs benefit or harm consumers? In order to address these questions, this Note proposes that the antitrust agencies use the “big data” collected under the Affordable Care Act to conduct a structured rule of reason review of ACOs that takes into account both the consumer surplus and total surplus through a burden-shifting framework.

David Shieh

As many as 98,000 people die each year as a result of medical error. According to law and economics scholars, the solution to this problem is straightforward: When calibrated correctly, medical malpractice liability will force healthcare providers to internalize the cost of their negligence, incentivizing improvements to patient safety that will reduce medical error. Debate has raged for decades over the coherence of deterrence theory, but little attention has been paid to the erosion of one of its bedrock assumptions: that the procedural mechanism through which claims are to be resolved is litigation. Arbitration has become pervasive in the healthcare context, but its effects on medical malpractice liability’s ability to deter medical error have been largely overlooked by public health and legal scholars. This Note argues that the adoption of arbitration will not, as law and economics scholars assume, improve the medical malpractice regime’s ability to deter error. In addition to drawing on existing law and economics and public health scholarship to advance this descriptive claim, this Note studies the experience of Kaiser Permanente, the nation’s largest integrated healthcare consortium, in using arbitration to resolve medical malpractice disputes with its seven million members in California.

 

Evelyn Lia Malave
Inadequate prison health care has created a health crisis for reentering prisoners and their communities—a crisis that is exacerbated by barriers to employment and other collateral consequences of release. This Note will first examine how current Eighth Amendment doctrine has failed to sufficiently regulate prison health care so as to have any significant effect on the crisis. Next, it will argue that the Affordable Care Act (ACA) alters the Eighth Amendment analysis by triggering a change in the “evolving standards of decency” that guide the doctrine. Specifically, this Note will argue that, after the passage of the ACA, releasing sick, Medicaid-eligible prisoners without enrolling them in the federal benefits program violates the Eighth Amendment.
Liora Sukhatme

The valuation of a pharmaceutical company often depends on its ability to bring a drug to market, making information about the likelihood of Food and Drug Administration (FDA) approval critical to investors and a highly sensitive issue for the company. Since the FDA drug approval process is not public, investors must rely on company disclosures to evaluate the likelihood of FDA approval. Currently, the FDA will not disclose the content of action letters sent to sponsor companies, giving company executives dangerous discretion over whether to disclose the information and how to present it. This discretion, coupled with a lack of oversight over the content of the disclosures, has resulted in several recent cases of fraud among pharmaceutical companies. As a way to curb such company discretion and prevent future fraud, this Note proposes mandatory public disclosure of action letters sent by the FDA to sponsor companies. 

Emily A. Bishop

Intersexed children are born with genitalia and/or reproductive organs that do not look like those of most biological males or females. Doctors and parents usually assign an intersexed child a gender at birth or during early childhood. Occasionally, an individual will reject his or her gender of assignment and will want to take on a different gender role. Some clinicians and intersex advocates instruct parents to accept an intersexed child’s expressions of gender identity and to support the child’s gender role change. There is a risk, however, that parents may resist or prevent a child’s gender transition due to their own discomfort with the idea or based on a physician’s recommendation. A statutory framework that allowed intersexed minors to complete a “social gender transition,” coupled with a provision equating parental interference with this transition with actionable neglect, would protect intersexed children’s autonomy and prevent the trauma that can result from a forced existence in a gender role with which a child does not identify. The proposed framework would likely survive a constitutional challenge by the parents of an intersexed child because the harm caused by the parental decision to interfere with a child’s gender expression removes such interference from the realm of constitutionally protected parental decisionmaking.