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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.

Extending the Affordable Care Act Under Equal Protection Law to Cover Male Sterilization

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.

Using “Big Data” to Better Analyze Accountable Care Organizations Under the Medicare Shared Savings Program

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.

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.

This Comment argues in favor of large-scale reform that would make it much more difficult to avoid immunizing children. Part I provides background on the sources of this problem and contends that there is an extremely strong state interest in eradicating diseases to which the countervailing individual interest in pursuing an adherence to junk science should pale in comparison. Part II argues that the state exemptions for religious and personal beliefs are both unnecessary and, again, misguided given the strong state interest in eradicating diseases. Part III explores the possibility of universal state-level or federal-level mandates for vaccination. The country has allowed the destructive impact of Jenny-McCarthyism to run rampant for far too long.

Andrew Janet, Striving for Herd Immunity, 90 N.Y.U. L. Rev. Online 1 (2015).