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Reducing Bias in Human Rights Fact-Finding: The Potential of the Clinical Simulation Model to Overcome Ethical, Practical, and Cultural Tensions in "Foreign" Contexts
No full textThis article considers the ethical tensions inherent in international human rights field documentation and proposes intensive, simulation model, pre-fieldwork training as a means of reducing the risk of insensitive encounters. The article evaluates the social, educational, class, racial, and other power imbalances between parties in the ordinary fact-finding process. After mapping pitfalls and challenges, it assesses the simulation training method and its potential to respond to the volatile dynamics of fact-finding. We
conclude that the rigorous, three-day or week-long exercise, carried out in a controlled, supervised setting, holds potential to train future advocates to navigate power dynamics, challenges in intercultural engagement, and other communications barriers
Tension in the Unitary Executive: How Taft Constructed the Epochal Opinion of Myers v. United States
No full textWilliam H. Taft is the only person ever to have served as both president of the United States and as chief justice of the Supreme Court of the United States. That unique confluence of roles is evident in Myers v. United States, an “epoch-making” and “landmark”case that Taft considered “one of the important opinions I have ever written.”
The precise question in Myers was “whether under the Constitution the President has the exclusive power of removing executive officers of the United States whom he has appointed by and with the advice and consent of the Senate.” Myers was the first decision in the history of the nation to invalidate a congressional statute on the grounds that it violated an inherent Article II power of the president. It was as if fate itself had reserved Myers until Taft could take his seat at the center of the Court
Drug Injury Advertising
No full textDrug injury advertising, which solicits consumers for lawsuits against drug and medical device manufacturers, is a $114 million business. Yet little is known about how consumers respond to the medical information contained in these ads. This study applies insights from the field of marketing to the drug injury advertising context, and further tests those insights through two experiments. Results suggest that some consumers are deceived by drug injury ads, and that some types of advertising are more deceptive than others. We also find that deceptive drug injury ads have a stronger influence on consumer risk perceptions and behavioral intentions, such as intentions to use the medication or seek additional information
More Prices, More Problems: Challenging Indication-Specific Pricing as a Solution to Prescription Drug Spending in the United States
No full textIn the United States, high prices of prescription drugs and rapidly increasing prescription drug spending have caused public outrage and calls for action. There is bipartisan acknowledgement of the problem by lawmakers, but no agreement on how to fix it. Value-based pricing models have gained increasing support and have been suggested as one possible solution to controlling prescription drug spending. One proposed value-based pricing model is indication-specific pricing: linking the price of a multi-indication prescription drug with the indication for which it is prescribed to a patient. Indication-specific pricing is intended to incentivize using higher-value treatments and allocating prescription drugs to patients who will receive the greatest benefit
Development of a National Public Pharmaceutical Research and Development Institute
No full textThe high cost of prescription drugs has featured prominently in the 2020 presidential campaign, reflecting the challenge millions of Americans face in affording their medications. Of greatest concern have been routine price increases of existing brand-name drugs and rapidly escalating launch prices of novel brand-name drugs. For example, of 36 top-selling brand-name drugs available in 2012, 16 (44%) more than doubled in cost by 2019, while the average annual cost of a new brand-name cancer drug now exceeds $150,000.
Many of these products would not have made it to market without taxpayer-funded support. The US National Institutes of Health (NIH) alone accounts for more than half of the research and development (R&D) spend reported by major pharmaceutical companies each year.5 This funding was linked at some level to the development of all 210 novel brand-name drugs approved between 2010 and 2016.6 Other public entities, such the Department of Defense and state organizations like the Cancer Prevention and Research Institute of Texas,7 also offer important support. Traditionally, funding from such institutions has covered basic and early-stage translational science, but a quarter of novel small-molecule brand-name drugs approved over the past decade were based in part on key late-stage publicly-supported contributions.
To better account for these contributions, some policymakers have proposed instituting fair pricing terms on applicable drugs. In August 2019, for example, Sen. Chris Van Hollen (D-MD) and Sen. Rick Scott (R-FL), introduced the We Protect American Investment in Drugs Act (We PAID) Act, which would establish a Drug Affordability and Access Committee to determine reasonable prices for drugs with patents disclosing federal funding
Partial "Global Peace": Federalism and the Long Tail of Remedies in Opiod Litigation,
No full textThe Opioid Litigation yields important insights for federalism and for remedies in complex multi-party and multi-prong cases. This
sprawling set of cases underscores that essentialized ideas of a set of fixed "state" and "federal" interests do not capture the diverse and often conflicting goals of states and subunits or of the national government. Likewise, this litigation serves as a reminder of the need to reframe assumptions about the role courts ought to play when considering settlements aiming "for global peace." Large-scale litigation is often thought to be a two-step process entailing a first decision to aggregate and a second step of either a trial or a settlement. But these forms of lawsuits do not end there. Law needs to clarify that a third step is needed because, even when interests are sufficiently homogenous to warrant aggregation at a litigation's inception and conclusion, differences can emerge thereafter when implementing remedies. Judges should use their authority to ensure that aggregated plaintiffs continue to have access to courts during all three phases of large-scale litigation. Recognition is needed that resolutions are partial because, after liability issues have been resolved, additional information often emerges about the individuals and entities to whom remedies are supposed to flow, and readjustments may be needed in the structure and allocation of relief
The Affordable Care Act's Litigation Decade
No full textThe decade of the Affordable Care Act (ACA) has been a decade in court.
The ACA is the most challenged statute in American history. The first lawsuits were filed moments after the law was enacted-on March 23, 2010-alleging that the ACA was unconstitutional.' Ten years later, the ACA is still under attack, being litigated in three Supreme Court cases within the current year alone -for a collective total of seven Supreme Court challenges in a decade. One of the pending cases is another major challenge to the statute's entire existence. Along the way, the statute has been rebelled against by the states charged with implementing it,' sabotaged by the second President to administer it, and financially starved by Congress. All of these events have fed a swirl of litigation and made for a story of unprecedented statutory resilience.
Everything about the ACA litigation-the stakes, the political and media attention, and even the number of hours of oral argument granted by the Supreme Court-has been "outsized," as one former U.S. Solicitor General aptly put it.' The breadth of the more than 2,000 legal challenges has been staggering. The litigation reveals the extensive reach of the ACA into all areas of our economy and
its effects far beyond healthcare. It shows the legal complexity of a federal law that does not rely solely on the federal government to administer it but relies on states and private actors as well. And it underscores the political and practical challenges of government intervention that aims to affect not only individual behavior but also private relationships, including those between employers and employees, and between patients and healthcare providers. For some, such interventions
are an unacceptable overreach.
The ACA is the most significant healthcare legislation in recent American history, at least since Medicare and Medicaid were enacted in 1965. The cases it has generated in court have, of course, shaped American healthcare and the programs that comprise it. But they also have shaped constitutional law, federalism, statutory interpretation, administrative law, and our conceptualizations of the fights and duties of states and private actors charged with implementing federal statutes
THE RIGHT TO BE HEARD: ONE Magazine, Obscenity Law, and the Battle Over Homosexual Speech
No full textIn the years following the Second World War, the movement for LGBT rights in the United States evolved dramatically from a state of near invisibility to one of outward protest and pride. How can historians account for this radical shift within the movement? Previous historical analyses have focused on the rise of queer consciousness. This article, however, suggests that growing consciousness does not provide a complete obscenity law must be taken into consideration
Gun Violence in Court
No full textLitigation cannot solve a public health crisis. But litigation can be an effective complementary tool to regulation by increasing the salience of a public health issue, eliciting closely guarded information to move public opinion, and prompting legislative action. From tobacco to opioids, litigants have successfully turned to courts for monetary relief, to initiate systemic change, and to hold industry accountable.
For years, litigators have been trying to push firearm cases into their own litigation moment. The recent success of the opioid litigation provides a tantalizing model for those who would turn to courts for gun control. But litigation against the gun industry
poses special challenges. Not only has the regulatory regime failed to prevent a public safety hazard, Congress has consistently underfunded and understaffed the relevant regulatory actors. And in 2005, it legislatively immunized the gun industry from suit with the Protection of Lawful Commerce in Arms Act (PLCAA) — a protection not replicated in any other field.
Over the last several decades, victims and stakeholders suing the gun industry have had limited success; victories remain confined to individual actors and unlike high-impact public litigations in other areas, aggregate class actions and major public litigation led
by state attorneys general are noticeably absent in the firearm context. Industry-wide, high leverage lawsuits have been critical turning points in suits involving other high-risk products. Why not for guns
Generic Competition for Drugs Treating Rare Diseases
No full textPrescription drugs are usually very expensive until patents on the brandname product expire, but prices of many older off-patent medicines have risen in recent years in the absence of effective generic competition. In 2015, for example, Turing increased the price of pyrimethamine, a 62-year-old drug to treat toxoplasmosis, by 5000%. More recently, Teva announced that it would price its
generic version of trientine (Syprine), a treatment for a deficiency in copper metabolism, at $18,375 per month — 28 times the list price for the brandname product in 2010.
One common feature of these two cases is that they involve drugs indicated for rare diseases. It has been estimated that over 7,000 rare diseases affect about 10% of Americans, few with effective treatments. In 1983, the Orphan Drug Act created a set of incentives for manufacturers to invest in the development of drugs for rare diseases, including a 7-year period in which the FDA cannot approve generic versions of the drug for the rare disease indication (“orphan drug exclusivity”). Since passage of the act, rare disease drugs have comprised an increasing share of new drug approvals. Between 1994 and 2004, 17% of new drugs had a rare disease indication; the following decade, 25% did.5 However, the prices of new drugs for rare diseases are often set extremely high and may be unaffordable for patients or strain payor resources.6 While manufacturers have justified high prices by pointing to the high cost of new drug development and the small size of rare disease markets, such prices have been tied to reduced adherence.
Like patients with more common diseases, patients with rare diseases benefit from low prices associated with the introduction of generic drugs for their conditions. However, generic drugs are only inexpensive if enough market entrants spark robust price competition. Previous research has found that a single generic competitor leads to reductions in price of about 10-15%, with prices not dropping by more than 50% until there are 4 or more generic manufacturers serving a market.8 Yet nearly one third of eligible drugs lack sufficient generic competition and are therefore at risk for high prices.
Drugs treating rare diseases may be at elevated risk of insufficient generic competition because generic manufacturers may avoid niche markets and prioritize drugs treating more prevalent conditions. To assess this hypothesis, we sought to determine the prevalence of generic availability and patent challenges — two measures of generic competition — among rare disease drugs stratified by measures of market size