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The Future of Medical Device Regulation: Innovation and Protection
No full textRegulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.https://scholarship.law.bu.edu/books/1252/thumbnail.jp
A Guide to Civil Procedure: Integrating Critical Legal Perspectives
No full textShines a light on the ways in which civil procedure may privilege—or silence—voices in our justice systemIn today’s increasingly hostile political and cultural climate, law schools throughout the country are urgently seeking effective tools to address embedded inequality in the United States legal system. A Guide to Civil Procedure aims to serve as one such tool by centering questions of systemic injustice in the teaching, learning, and practice of civil procedure.Featuring an outstanding group of diverse scholars, the contributors illustrate how law school curriculums often ignore issues such as race, gender, disability, class, immigration status, and sexual orientation. Too often, students view the #MeToo movement, Black Lives Matter, immigration/citizenship controversy, or LGBTQ+ issues as mere footnotes to their legal education, often leading to the marginalization of many students and the production of graduates that do not view issues of systemic injustice as central to their profession.A Guide to Civil Procedure reveals how procedure is, and always has been, a central pressure point in the struggle to eradicate structural inequality and oppression through the courts. This book will give students and scholars alike a more complex view of their roles as attorneys, sharpen their litigation skills, and provide a stronger sense of community and purpose in the law school classroom.https://scholarship.law.bu.edu/books/1249/thumbnail.jp
Reclaiming Equality: How Regressive Laws Can Advance Progressive Ends
Get PDFSince the fall of 2020, right-wing forces have targeted Critical Race Theory ( CR T\u27) through a sustained disinformation campaign. This offensive has deployed anti-CRT rhetoric to justify a host of Backlash Bills designed to chill conversations about race and racism in the classroom. Concerned stakeholders have assailed these laws as morally bankrupt and legally suspect. These responses are natural and appropriate. But challenging a bill\u27s moral or legal mooring is insufficient to counter a primary purpose of this legislative onslaught: to further erode, within our public discourse and collective consciousness, the ability to distinguish between racism and antiracism. To meet this threat, advocates should reappropriate these regressive laws, and the language of equality they harness, for progressive ends. More concretely, stakeholders should wield Backlash Bills to defend CRT in schools. Albeit counterintuitive, many anti-CRT laws if we take seriously their text support this rhetorical and legal turn
Teacher and Lawyer, Constance Browne Is Driven by Social Justice
Get PDFConstance Browne’s passion for justice has deep roots.
William Holt, her grandfather, was born in a women’s prison outside Boston in either 1887 or 1888. His mother had been incarcerated—no one is sure why. Then, when Holt was three or four years old, he was taken by rail to Maine with other orphans intended to become farm laborers. Did his mother consent to letting him go? No one knows that either.
Eventually Holt landed with a family in North Waterford who treated him well, though it seems he was never adopted. He graduated from Bowdoin College and the Medical School of Maine, becoming a cancer researcher and the kind of beloved country doctor who would accept payment in chickens or produce from patients who had no money to spare.
“He has always been my heart and my hero,” says Browne, a Boston University School of Law clinical professor of law. “Devotion to others was at the core of his being.” That same devotion, to her students, is one reason Browne has been named this year’s winner of the Metcalf Cup and Prize, the University’s highest award for teaching, to be presented at BU’s Commencement on Sunday, May 22
Competition and Innovation: The Breakup of IG Farben
Get PDFThe relationship between competition and innovation is difficult to disentangle, as exogenous variation in market structure is rare. The 1952 breakup of Germany’s leading chemical company, IG Farben, represents such a disruption. After the Second World War, the Allies occupying Germany imposed the breakup because of IG Farben’s importance for the German war economy instead of standard antitrust concerns. In technology areas where the breakup reduced concentration, patenting increased strongly, driven by domestic firms unrelated to IG Farben. An analysis of patent texts shows that an increased propensity to patent does not drive the effect. Descriptively, IG Farben’s successors increased their patenting activities as well, and their patenting specialized relative to the pre-breakup period. The results are consistent with a breakup-induced innovation increase by the IG Farben successors, which then spilled over to the wider chemical industry
Civil Rights Catch 22s
Get PDFCivil rights advocates have long viewed litigation as a vital path to social change. In many ways, it is. But in key respects that remain underexplored in legal scholarship, even successful litigation can hinder remedial projects. This perverse effect stems from civil rights doctrines that incentivize litigants (or their attorneys) to foreground community plight—such as academic underachievement or overincarceration. Rational plaintiffs, responding in kind, deploy legal narratives that tend to track racial stereotypes and regressive theories of inequality. When this occurs, even successful lawsuits can harden the structural and behavioral forces that produce and perpetuate racial inequality.
I refer to this dynamic as a “civil rights catch-22.” To concretize this phenomenon and its effects, I explore recent right-to-education lawsuits featuring low-income students of color. The cases reveal how doctrine can drive plaintiffs to portray themselves and their communities through a lens of poverty and illiteracy. Even if strategic from a litigation perspective, the proliferation of such narratives can entrench disparities across educational domains.
For decades, critical race theorists have revealed how the law “constructs” race. This Article builds on that canon but shifts the lens to litigation itself. For those committed to meaningful racial reform, better understanding this dynamic is essential—particularly given the emancipatory role that civil rights litigation is understood to fulfill
Breached!: Why Data Security Law Fails and How to Improve It
Get PDFDigital connections permeate our lives—and so do data breaches. Given that we must be online for basic communication, finance, healthcare, and more, it is remarkable how difficult it is to secure our personal information. Despite the passage of many data security laws, data breaches are increasing at a record pace. In their book, BREACHED! WHY DATA SECURITY LAW FAILS AND HOW TO IMPROVE IT (Oxford University Press 2022), Professors Daniel Solove and Woodrow Hartzog argue that the law fails because, ironically, it focuses too much on the breach itself.Drawing insights from many fascinating stories about data breaches, Solove and Hartzog show how major breaches could have been prevented or mitigated through better rules and often inexpensive, non-cumbersome means. They also reveal why the current law is counterproductive. It pummels organizations that have suffered a breach but doesn’t recognize how others contribute to the breach. These outside actors include software companies that create vulnerable software, device companies that make insecure devices, government policymakers who write regulations that increase security risks, organizations that train people to engage in risky behaviors, and more.Although humans are the weakest link for data security, the law remains oblivious to the fact that policies and technologies are often designed with a poor understanding of human behavior. BREACHED! sets forth a holistic vision for data security law—one that holds all actors accountable, understands security broadly and in relationship to privacy, looks to prevention and mitigation rather than reaction, and is designed with people in mind. The book closes with a roadmap for how we can reboot law and policy surrounding data security.https://scholarship.law.bu.edu/books/1338/thumbnail.jp
Massachusetts Health and Hospital Law Manual: Third Edition
No full textTaking an interdisciplinary, industry-based approach, MCLE\u27s Massachusetts Health and Hospital Law Manual presents the many business and legal issues facing health care providers, payors, and other participants in the health care industry, along with the regulators overseeing them. This comprehensive manual focuses on health care delivery in its legal, business, regulatory, advocacy and personal aspects. Practice pointers and hypotheticals provide concrete guidance as you navigate the federalization, consolidation, bureaucratization, and increasing regulation of this dynamic area of practice
Delaware\u27s Dominance, Wyoming\u27s Dare: New Challenge, Same Outcome?
Get PDFDespite increasing criticism, Delaware\u27s dominance in corporate law has not experienced a significant decline: as of today, 67.8 percent of Fortune 500 companies are still incorporated in its jurisdiction. Nevada is known as Delaware\u27s most important competitor, with an aggressive strategy that has overridden the efforts of any other jurisdiction. Yet, its success has been limited to a specific market segment: small firms with low institutional shareholding and high insider ownership.
Scholars suggest several explanations for both the rise and the staying power of Delaware. These explanations are essentially subsumed under the credible commitment theory and the network theory. According to the former, investors rely upon Delaware\u27s commitment towards the business community; while the latter emphasizes how Delaware is profiting from the position it has achieved. The credible commitment theory and the network theory sometimes overlap and combine. Both predict that Delaware is hard to dethrone.
In recent years, commentators have argued that this hegemony might be endangered by two different threats: the migration of cases induced by Delaware courts\u27 response to overlitigation; and the invasive growth of federal regulation in particular, the possible introduction of a federal incorporation. Yet, criticisms and predictions on Delaware\u27s decline are recurring and always follow the same pattern. In this instance, unsurprisingly, the migration turned out to be marginal, and although the debate on a federal incorporation was revived in conjunction with a political campaign, it fizzled out soon after the Democratic primaries ended.
I contend that a mounting challenge to Delaware\u27s dominance is mostly flying under the radar. Wyoming is targeting a new segment of the market for corporate charters: digital asset businesses. This jurisdiction is attempting to attract these incorporators by enacting liberal legislation and providing their companies with a safe harbor
Wyoming\u27s aggressive stance provides the motivation to canvass causes and consequences, criticism, and challenges to Delaware\u27s dominance. The investigation can generate insights as to why Wyoming\u27s strategy will succeed or fail. In fact, this market segmentation approach is the same tactic that Nevada adopted, though Wyoming is applying the strategy to a sector that has meaningful growth potential and is pushing it to the point of introducing exemptions to state securities laws and banking regulation.
The application of the credible commitment theory and the network theory to Wyoming\u27s approach suggests that this strategy of building a reputation and proving a commitment to tech-incorporators is on the right track, but success also requires a confluence of events that need time. To ensure supremacy in digital assets, Wyoming should develop an expertise that is too costly to be easily replicated by other jurisdictions and earn a share of the charters market before federal legislature and regulatory bodies pre-empt Wyoming\u27s law for cryptocurrencies.
To the extent that Wyoming\u27s strategy proves to be effective, it will gain this jurisdiction the lead only in the blockchain segment of the market, while Delaware will continue to dominate the rest of corporate law.
In light of all this, Wyoming\u27s approach might be a dare. Yet, it is also the most promising maybe the only possible-challenge to Delaware\u27s dominance at the present time
An Argument Against Unbounded Arrest Power: The Expressive Fourth Amendment and Protesting While Black
Get PDFProtesting is supposed to be revered in our democracy, considered “as American as apple pie” in our nation’s mythology. But the actual experiences of the 2020 racial justice protesters showed that this supposed reverence for political dissent and protest is more akin to American folklore than reality on the streets. The images from those streets depicted police officers clad in riot gear and armed with shields, batons, and “less than” lethal weapons aggressively arresting protesters, often en masse. In the first week of the George Floyd protests, police arrested roughly 10,000 people, and approximately 78 percent of those arrests were for nonviolent misdemeanor offenses or criminal violations. Moreover, troubling figures regarding the racial breakdown of protest-related arrests, along with anecdotes from activists, suggest that just as with routine policing, the experiences of Black and white people differ during protests—even when they protest side by side—with police potentially targeting Black activists for arrest. This Article exposes how police officers’ easy access to a wide arsenal of criminal charges serves to trample on expressive freedoms and explains how a new and clearer understanding of the Fourth Amendment’s application to expressive conduct should curb the police’s seemingly unbounded power to arrest protesters.
In Part I of this Article, I revisit and review the roots and rationale of the Expressive Fourth Amendment doctrine, which posits that there is an expressive component to Fourth Amendment protection. In Part II, I discuss the criminal statutes that police often use to make arrests during protests and then focus more narrowly on the arrests in New York City in the early days of the George Floyd demonstrations, including the racial makeup of arrestees. In Part III, I explain how the presiding understanding of the Fourth Amendment places minimal limits on a police officer’s ability to arrest, regardless of an individual’s engagement in expressive political conduct. Thereafter, I describe how the Expressive Fourth Amendment should apply to arrests and serve to curtail an officer’s ability to engage in warrantless arrests of protesters for nonviolent misdemeanors