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| Spotted at Rummy Mini Mart, Factory Road, Port of Spain, Trinidad. |
Friday, July 26, 2019
Torte-spotting
Not savory. Not a tort. Possibly not actual food. And yet my interest is piqued.
Monday, July 15, 2019
'Genetically modified humans are among us'
An alum of my constitutional law class, Paul Enríquez, J.D., LL.M., Ph.D.—Structural and Molecular Biochemistry, is doing some stellar academic work at the cutting edge of genetic science and law and policy. He privileged me with a sneak peak at his latest contribution to the legal literature, now available on SSRN, Editing Humanity: On the Precise Manipulation of DNA in Human Embryos, forthcoming in 97 N.C. L. Rev. Here is the abstract:
Genetically modified humans are among us. Emerging technologies for genome editing have launched humanity into the uncharted territory of modifying the human germline—namely, the reproductive cells and embryos that carry our genetic ancestry. Reports of the first live births of humans with edited genomes in China recently confirmed that the power to manipulate our genes at an embryonic stage is no longer theoretical. In the wake of enormous scientific progress, questions regarding how the law will treat this technological breakthrough abound.
This Article examines the legality of human genome editing, specifically germline genome editing (“GGE”), from administrative and constitutional law perspectives. It argues that the Food and Drug Administration’s (“FDA” or “Agency”) forbearance in claiming jurisdiction over GGE is creating a perilous void for an emerging field of law. At the same time, the contemporary de facto legislative ban on GGE clinical applications, which categorically prohibits the Agency from evaluating the safety and efficacy of any investigational new drug or biological product application derived from the technology, is unnecessary and creates more societal costs than benefits. On a broad scale, the ban embodies poor public policy because it prevents the FDA from exercising jurisdiction over matters that constitute extensions of the Agency’s traditional regulatory scope. An analysis of the law reveals salient regulatory gaps that could be viewed as rendering some types of GGE beyond the FDA’s regulatory reach. Notwithstanding those gaps, this Article argues that the FDA can work within the existing statutory framework to cure regulatory deficits and promulgate rules to regulate the technology and, thus, urges the FDA to exercise that jurisdiction. This Article ultimately demonstrates how law and policy converge into a proposed new regulatory paradigm for human GGE that flows from the D.C. Circuit’s ruling in United States v. Regenerative Sciences, LLC, which held that specific stem cell mixtures can be regulated as drugs or biological products within the meaning of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.
This Article further contends that efforts to ban GGE technologies cannot withstand constitutional scrutiny in the long run because they impinge on a cognizable fundamental right that protects select uses of GGE. This fundamental right flows from jurisprudence in the areas of procreative, parental, and—to some extent—privacy rights, but it is not absolute. The Article presents an interpretive model for this body of jurisprudence in the GGE context, which promotes extrapolation of applicable legal principles that can guide and promote coherent public policy. Launching from this jurisprudential departing point, this Article introduces a novel legal- and science-based normative framework to delineate primary limits for a right to perform GGE based upon four distinct categories: (1) therapeutic uses to remedy disease; (2) prophylactic purposes, which may or may not be therapeutic; (3) cosmetic or enhancement purposes; and (4) uses involving modification of traits that raise concerns of discrimination already prohibited by the law. This conceptual and structural approach outlines a legal blueprint for GGE clinical interventions, but more importantly it circumvents problems that dominate the existing literature, which arise from the conventional tendency to group GGE applications into therapeutic uses on one hand, and enhancements on the other.
Saturday, July 13, 2019
Law student, doctor's blog explores medmal issues
An alum of my Torts I & II classes and a medical doctor, Joseph Grillo is doing some intriguing blogging at his Medical-Legal Consulting website. Here's a teaser to a recent (May 31) item:
Vicarious Liability Doctrines in Medical Malpractice: Ostensible or Apparent Agency
It is commonplace today that hospitals do not employ physicians. Instead the physician is considered an independent contractor. This relationship may muddy the waters when trying to hold a hospital to account under vicarious liability.
There exists an exception to the general rule that a hospital incurs no liability for the negligence of independent contractors but only for those who provide care within the traditional employment relationship.
The doctrine of ostensible agency or apparent authority has been the predominant theory upon which to base an action for vicarious liability against a hospital for the negligence of independent contractors.
Tuesday, July 9, 2019
Amity Dubai hosts global mass comm conference
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| My plenary session on "the death of journalism?" and desinformación online. |
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| Dean Fazal Malik and Professor Manish Verma |
The best of the conference of course came from what I was able to learn from my colleagues of such far-ranging experiences, backgrounds, and focuses of study. I'll comment on some photographic highlights here, though this testimony will not express how deeply this program enriched my experience in comparativism.
Interdisciplinary presenters brought perspective to problems in mass communication. Social media researchers Fathima Linsha Basheer and Sudha Bhattia are considering the implications of this factoid: ten minutes' tweeting yields 13% oxytocin increase in brain. Oxytocin is also known as "the love hormone."
"Dr. G.," Dr. Geentanjali Chandra, is the head of the law school at Amity Dubai. Amity Dubai is the only school outside of India accredited to allow its graduates to sit for the bar in India.
Dr. G. kindly invited me to talk to a law class. Students studying at Amity Dubai are surprisingly diverse. The UAE creates a curious dynamic: Indian migrants--already an intrinsically diverse population--make up some quarter of the population of the Emirates and have established multi-generational households. Yet they remain Indian citizens. As a result, the young generation has a unique global identity.
Amity Dubai studded the scholarly program with creative contributions from the range of student talents fostered at the university, including fashion, dance, and film. Film students spent just one week creating a short-film horror project titled, "Out of Order." I'm getting in the ground floor as a fan of up-and-coming director Ruslan Baiazov.
Monday, July 8, 2019
U.S. Supreme Court widens tort liability exposure of New Deal-era, state-owned enterprises
On April 29, the U.S. Supreme Court held against the Government by reversing and remanding unanimously in Thacker v. Tennessee Valley Authority, No. 17-1201 (Oyez), a negligence claim arising under the Federal Tort Claims Act of 1946 (FTCA).
Per Justice Kagan, the Court held that the test for sovereign immunity in tort claims against New Deal-era "sued and be sued" entities such as the TVA is twofold. First, the court must determine whether the conduct of the defendant was commercial or governmental. Sovereign immunity can attach only to governmental conduct. Second, if governmental, the court must determine whether suit is clearly inconsistent with constitutional or statutory scheme, or suit clearly would threaten interference with the governmental function (the test of FHA v Burr (U.S. 1940)). Only in those narrow cases—much narrower than the statutory discretionary function exception to FTCA's waiver of sovereign immunity—does sovereign immunity attach.
The Court's decision hews to the plain text of the TVA Act of 1933 and represents a win for plaintiffs. The case also throws into doubt other lines of federal case law in which the courts have borrowed and extended immunity concepts by analogy to the FTCA to shield government actors from liability in other statutory contexts.
You can hear my verbal review of the case at the Federalist Society's SCOTUScast. Hear my pre-decision, post-argument analysis on SCOTUScast and view pre-argument analysis with engaging visuals from the Federalist Society on SCOTUSbrief. The case is on SCOTUSblog with record links and informative analysis by Gregory Sisk. Find the opinion and oral argument at Oyez.
Per Justice Kagan, the Court held that the test for sovereign immunity in tort claims against New Deal-era "sued and be sued" entities such as the TVA is twofold. First, the court must determine whether the conduct of the defendant was commercial or governmental. Sovereign immunity can attach only to governmental conduct. Second, if governmental, the court must determine whether suit is clearly inconsistent with constitutional or statutory scheme, or suit clearly would threaten interference with the governmental function (the test of FHA v Burr (U.S. 1940)). Only in those narrow cases—much narrower than the statutory discretionary function exception to FTCA's waiver of sovereign immunity—does sovereign immunity attach.
The Court's decision hews to the plain text of the TVA Act of 1933 and represents a win for plaintiffs. The case also throws into doubt other lines of federal case law in which the courts have borrowed and extended immunity concepts by analogy to the FTCA to shield government actors from liability in other statutory contexts.
You can hear my verbal review of the case at the Federalist Society's SCOTUScast. Hear my pre-decision, post-argument analysis on SCOTUScast and view pre-argument analysis with engaging visuals from the Federalist Society on SCOTUSbrief. The case is on SCOTUSblog with record links and informative analysis by Gregory Sisk. Find the opinion and oral argument at Oyez.
Saturday, July 6, 2019
Practical obscurity, other privacy arguments deliver blow to media in Mass. FOIA case
The Massachusetts Supreme Judicial Court (SJC) decided a state open records case in mid-June that invites lower courts to substantially broaden privacy exemption from access to information. The case is Boston Globe Media Partners, LLC v. Department of Public Health, No. SJC-12622 (Mass. June 17, 2019) (Lexis).
The Boston Globe is seeking access to a database of state birth, marriage, and death records from the Department of Public Health (DPH). In disagreement with state administrative officers enforcing the open records law, DPH refused access in part, citing statutory protections of personal privacy. The SJC rejected dispositive motions from both sides, electing to clarify the law and remand for a range of further fact finding.
The case resonates with various problems that have become familiar to privacy law over the last few decades. First, can privacy arise in a compilation of records, when the records are not private one by one? Second, can privacy preclude disclosure of records in government possession because the records are more about individuals than about the government? Third, how can personal privacy in electronic public records account for an individual's hypothetical privacy interests in the future?
First, the compilation problem arises in that these vital records already are available to the public. Members of the public are allowed to go to DPH's research room during 11 opening hours each week to view vital records in the electronic database. There are limitations, though. A researcher must search for a name, viewing responsive records only one at a time. Printing is not available, though there is no limitation on copying down information.
At issue legally, then, is whether mere compilation can change the public/private disposition of a record. Historically, the answer to this question was no. Norms of public records law as it developed in the 20th century held that a record should be evaluated within its four corners.
However, that position changed at the federal level, under the federal Freedom of Information Act (FOIA), with the landmark case, U.S. Department of Justice v. Reporters Committee for Freedom of the Press (U.S. 1989). In that early instance of database access, the Supreme Court construed the FOIA contrary to access on various grounds. The case was an infamous loss for the access NGO Reporters Committee, which filed as amicus on behalf of the Globe in this case.
Among the conclusions of Reporters Committee, the Court embraced the doctrine of practical obscurity: the notion that a record that is hard to find, whether by rifling through paper or by collecting geographically disparate components, may therein preserve a privacy interest against disclosure when compiled electronically with other such records. With its limitations on record access through the research room, DPH means to effect practical obscurity. The SJC was receptive to the argument, and it will remain to the lower court to decide what weight that privacy holds. Practical obscurity has been a thorn in the side of access advocates for the 30 years since Reporters Committee, while it has captivated courts.
Second, the content problem goes to the disputed heart of access law, its purpose. In Reporters Committee and subsequent cases, the federal courts embraced the cramped position that the purpose of access law is to reveal "what government is up to." Thus when records contain personal information, access opponents ground resistance in statutory purpose without even needing to rely on privacy exemptions.
Access advocates have argued powerfully against this position, especially in the states. Simply knowing what information government is collecting about individuals seems an important priority in the digital age. And the limited purpose argument ignores the plain theoretical position that government records are public records simply by virtue of ownership or possession, because ours is a government of the people.
On this score the SJC was more solicitous of a broad construction. The state law expressly cites the watchdog purpose. Nevertheless, the Court reasoned that the statute more broadly means to further public interests, which may require disclosure even of personally identifying information in public possession. At the same time, the Court observed that public interests may weigh against disclosure, acknowledging personal privacy protection as a public interest. In the instant case, the Court cited only a public interest in record accuracy, as argued by the Globe, to favor disclosure. The balance is left to remand, but the interest of accuracy seems thin relative to the array of privacy arguments deployed by DPH.
That array arises in connection with the third and most contemporary problem, the protection of individuals' hypothetical privacy interests. Here again is a privacy interest that conventional access law would have disregarded. Yet the SJC was solicitous.
This same problem has been much discussed in the internet age in the guise of the right to be forgotten, or right to erasure. If a government entity is obliged to disclose databases upon demand, then it becomes difficult, if not impossible, to withdraw information from the public sphere later. Access absolutists say, so be it. But privacy advocates assert that meritorious processes for correcting or sealing sensitive public records, such as criminal histories or family matters, are undermined by an internet that "never forgets."
Especially with regard to vital records, the SJC spent some ink on the problem of sex changes and the discovery of a person's birth identity. That is a factor rightly weighed into the privacy balance on remand, the Court held. While evincing compassion, the Court's position is sure to rile access advocates. There seems no logical stopping point from the Court's position to the conclusion that all personally identifying information must be protected against disclosure, in case any one person wishes to change identity in the future. That would be a rule ripe for abuse in official hands.
This decision is bad news for access advocates. It invites privacy to the table as a weight co-equal with access, virtually lifting the presumption-of-access thumb from the scale. The government won broad discretion to conceal its activities relative to people.
At the same time, the Court showed itself to be in step with contemporary privacy law. For better and worse, people are looking to government to protect them against abuses of information in the private sector, from identity theft to big data analytics. In the absence of legislation, the courts have been ever more inclined to oblige.
It remains to be seen what price this protection will exact from transparency and accountability of the government itself.
The Boston Globe is seeking access to a database of state birth, marriage, and death records from the Department of Public Health (DPH). In disagreement with state administrative officers enforcing the open records law, DPH refused access in part, citing statutory protections of personal privacy. The SJC rejected dispositive motions from both sides, electing to clarify the law and remand for a range of further fact finding.
The case resonates with various problems that have become familiar to privacy law over the last few decades. First, can privacy arise in a compilation of records, when the records are not private one by one? Second, can privacy preclude disclosure of records in government possession because the records are more about individuals than about the government? Third, how can personal privacy in electronic public records account for an individual's hypothetical privacy interests in the future?
First, the compilation problem arises in that these vital records already are available to the public. Members of the public are allowed to go to DPH's research room during 11 opening hours each week to view vital records in the electronic database. There are limitations, though. A researcher must search for a name, viewing responsive records only one at a time. Printing is not available, though there is no limitation on copying down information.
At issue legally, then, is whether mere compilation can change the public/private disposition of a record. Historically, the answer to this question was no. Norms of public records law as it developed in the 20th century held that a record should be evaluated within its four corners.
However, that position changed at the federal level, under the federal Freedom of Information Act (FOIA), with the landmark case, U.S. Department of Justice v. Reporters Committee for Freedom of the Press (U.S. 1989). In that early instance of database access, the Supreme Court construed the FOIA contrary to access on various grounds. The case was an infamous loss for the access NGO Reporters Committee, which filed as amicus on behalf of the Globe in this case.
Among the conclusions of Reporters Committee, the Court embraced the doctrine of practical obscurity: the notion that a record that is hard to find, whether by rifling through paper or by collecting geographically disparate components, may therein preserve a privacy interest against disclosure when compiled electronically with other such records. With its limitations on record access through the research room, DPH means to effect practical obscurity. The SJC was receptive to the argument, and it will remain to the lower court to decide what weight that privacy holds. Practical obscurity has been a thorn in the side of access advocates for the 30 years since Reporters Committee, while it has captivated courts.
Second, the content problem goes to the disputed heart of access law, its purpose. In Reporters Committee and subsequent cases, the federal courts embraced the cramped position that the purpose of access law is to reveal "what government is up to." Thus when records contain personal information, access opponents ground resistance in statutory purpose without even needing to rely on privacy exemptions.
Access advocates have argued powerfully against this position, especially in the states. Simply knowing what information government is collecting about individuals seems an important priority in the digital age. And the limited purpose argument ignores the plain theoretical position that government records are public records simply by virtue of ownership or possession, because ours is a government of the people.
On this score the SJC was more solicitous of a broad construction. The state law expressly cites the watchdog purpose. Nevertheless, the Court reasoned that the statute more broadly means to further public interests, which may require disclosure even of personally identifying information in public possession. At the same time, the Court observed that public interests may weigh against disclosure, acknowledging personal privacy protection as a public interest. In the instant case, the Court cited only a public interest in record accuracy, as argued by the Globe, to favor disclosure. The balance is left to remand, but the interest of accuracy seems thin relative to the array of privacy arguments deployed by DPH.
That array arises in connection with the third and most contemporary problem, the protection of individuals' hypothetical privacy interests. Here again is a privacy interest that conventional access law would have disregarded. Yet the SJC was solicitous.
This same problem has been much discussed in the internet age in the guise of the right to be forgotten, or right to erasure. If a government entity is obliged to disclose databases upon demand, then it becomes difficult, if not impossible, to withdraw information from the public sphere later. Access absolutists say, so be it. But privacy advocates assert that meritorious processes for correcting or sealing sensitive public records, such as criminal histories or family matters, are undermined by an internet that "never forgets."
Especially with regard to vital records, the SJC spent some ink on the problem of sex changes and the discovery of a person's birth identity. That is a factor rightly weighed into the privacy balance on remand, the Court held. While evincing compassion, the Court's position is sure to rile access advocates. There seems no logical stopping point from the Court's position to the conclusion that all personally identifying information must be protected against disclosure, in case any one person wishes to change identity in the future. That would be a rule ripe for abuse in official hands.
This decision is bad news for access advocates. It invites privacy to the table as a weight co-equal with access, virtually lifting the presumption-of-access thumb from the scale. The government won broad discretion to conceal its activities relative to people.
At the same time, the Court showed itself to be in step with contemporary privacy law. For better and worse, people are looking to government to protect them against abuses of information in the private sector, from identity theft to big data analytics. In the absence of legislation, the courts have been ever more inclined to oblige.
It remains to be seen what price this protection will exact from transparency and accountability of the government itself.