Note: The following article concerns a 2006 guidance from the FDA, which purported to affect the way preclinical drug testing is carried out. As noted, I am interested in this subject, and I'd like to do so more work on it, regarding, for example, how this matter is affected by the notice of proposed rulemaking concerning the federal Common Rule concerning human subjects research.

Given recent developments, I am not sure I will post this on the Social Sciences Research Network (SSRN). However, I am not entirely satisfied with the way the footnotes are produced on this blogger website. If any scholars have suggestions, I'd be gratified to hear from you. My email address is on the blog.

Phase 0 Trials: A Fait Accompli?

A Reappraisal From a Ten-Year Perspective (1)

by John Otrompke, JD(*)

In 2006, the FDA released a guidance on Phase 0 trials, in which a ‘microdose’ ( less than 1% of the expected dose) of an experimental drug is administered to humans for a very brief period of time (perhaps one week).2

The guidance generated controversy, such as an article raising ethical questions like whether it is ethical to subject humans to the risk of taking a new drug, which has been subjected to less rigorous preclinical research than in a traditional Phase 1 trial, without offering the possibility of enjoying a therapeutic benefit.3

Today, Phase 0 trials occur frequently, without substantive comment.4 In fact, the entire proposal in advance of amending the U.S. Common Rule doesn’t even mention them.5 So ten years out, are Phase 0 trials a fait accompli?

It would seem so. When Prof. Kimmelman wrote his article, his review of the literature found no more than 10 such studies. Perhaps for this reason, the 2007 article raised, but did not attempt to answer, such ethical questions.

But a similar search conducted on PubMed last month returned 1,892 hits for Phase 0 trials, and 544 hits for microdosing; a search on clinicaltrials.gov returned 97 studies. Regulators in Australia(6) and the European Union(7) have given Phase 0 trials their blessing.

Have the ethical issues raised by Prof. Kimmelman ever been addressed? At least one of the ethical questions he raised, whether Phase 0 trials have scientific value, seems to have been answered, at least to the satisfaction of society and the scientific community. 

Another issue, however, has never been sufficiently addressed: whether society is permitting human volunteers to subject themselves to an unquantifiable but substantial risk, to which they cannot truly consent. 

This article takes the position that Phase 0 trials are part of a next-generation tool-box for drug discovery (including genomic browsers, micro-fluidics, biomarkers, gene signatures and other modern techniques) that may one day eliminate animal testing,(8) and cure cancer. While the practice of Phase 0 trials is only likely to accelerate given the administration’s National Cancer Moonshot initiative, the federal government should take the opportunity presented by the proposal to amend the Common Rule(9) to produce a more definitive response to the ethical issues they raise.

What are Phase 0 Trials?

In its 2006 guidance, FDA defines the concept of microdose trials, and lays out how to use them.

In traditional, pre-2006 drug development, clinical trial research was broken down into three phases, preceded by basic, in vitro research, proof-of-concept, and animal testing; Phase 1, in which doses of a medicine were administered to human beings for titration and to further test for safety; Phase 2, in which the experimental medicine is given to larger numbers of patients, to further test for safety as well as efficacy; and Phase 3, the most complete and scientifically rigorous phase, in which the medicine is administered to a cohort large enough to generate statistically significant results, the primary endpoint being efficacy. 

In order to conduct a Phase 1 trial, a drug developer needs to submit an application to FDA. In its guidance, FDA explained that many drug developers submitted vastly more data than necessary to get approval for Phase 1 trials, unnecessarily constricting scientific progress and hindering medical progress.10 

The FDA explained just how little scientific evidence is necessary to justify a Phase 1 trial, and encouraging drug developers to rely on a hitherto under-utilized technique called the Phase 0, or microdose trial. The point was to simplify the process by sorting out the more promising agents by trying them out earlier in humans in a microdose form.

While traditional Phase 1 trials had once been referred to as ‘first-in-human’ studies, with Phase 0 research, this is no longer the case. 

What Ethical Issues Have Been Raised?

What exactly is the ethical difference between Phase 0 and Phase 1? Chiefly, while the likelihood of a human subject receiving a therapeutic benefit from a Phase 1 trial is small, the odds of receiving any therapeutic benefit from a Phase 0 trial are virtually nil, partially because the dose of the experimental drug is so small, and the period of administration is so brief.11

Stepping back, the U.S. government’s three basic watchwords for bioethical regulation may be found in the Belmont Report, the document which informed the creation of the Common Rule: respect for persons, beneficence, and justice. 

Many of the criticisms leveled at Phase 0 trials come from the proposition that risks and benefits faced by human subjects must be proportional. (Prof. Kimmelman expressly excluded consideration of research in healthy people from his consideration, but the FDA guidance said that exploratory studies could be conducted in healthy individuals).12 Unlike in traditional Phase 1 trials, the dose of the experimental agent in a Phase 0 trial is very small. Therein lies the rub. 

First-in-human studies of experimental medicines can pose grave health hazards. The Guidance addresses such concerns by encouraging animal testing in a rather unrestrained way, notwithstanding the burgeoning evidence that animal research does not produce results reliably generalizable to human beings.13 (At the same time, federal agencies are doing significant work in developing alternatives to animal testing through programs like ICCVAM and NICEATM, programs in which FDA is involved, but in which FDA should place greater confidence).14

Therefore, a human individual taking part in a Phase 0 trial often assumes a significant risk, without much likelihood of enjoying a personal medical benefit. An adult might assume a risk to herself or himself for the benefit of others.15 It is assumed that this can be ethically permissible, if the benefit to others is sufficient. But experimental drugs are tested in humans earlier than was the case in traditional Phase I studies, which involved a more rigorous period of preclinical study. Prof. Kimmelman asks us whether the public benefit is sufficient to justify greater individual risk if Phase 0 trials are unlikely to lead to generalizable scientific knowledge, because, for example, the results of Phase 0 trials may never be publicly available. Is it just if human beings are exposed to danger, not to develop generalized knowledge, but to advance the individual development of a privately-owned drug that will ultimately be sold for profit, sometimes at objectionable rates? Is it possible for an individual to consent in a truly autonomous way to willingly participate in such an unequivocally unilateral procedure, and why would they do so?

To really answer these questions, it would be necessary to quantify the risk to which those who volunteer for Phase 0 trials are subjecting themselves. Are human volunteers experiencing more adverse events than before? Are any Phase 0 volunteers enjoying pharmacological benefit? 

Bioethicists have commented that this is a difficult calculation, because it is difficult to keep track of adverse events encountered by volunteers in clinical trials. These concerns may have been partially alleviated by the expansion of the ClinicalTrials.gov database, which was expanded again this month.16 According to the agencies, the database can be searched for adverse events.

Ten years on, federal regulators and the not-infallible scientific community seem to have concluded that Phase 0 trials present enough promise to justify the individual risk to human volunteers. (Concerns that the benefit is private could perhaps be better addressed by efforts to reform the phenomena of commerce more generally). 

It may be that the outcome of the Cancer Moonshot Initiative will ultimately determine whether the sacrifices made by individual human beings were worthwhile.

Conclusion

Some say that the focus of bioethical regulation in the U.S. has shifted from informed consent to an emphasis on access to experimental medicine. In light of the observations and conclusions contained above, Phase 0 trials are indeed a fait accompli, for the time being at least; but because the history of medical ethics in the last century has been reactive in nature, that could change.

Probably the most important document of research ethics since the turn of the century is the notice of proposed rulemaking to amend the Common Rule.17 The NPR doesn’t explicitly mention Phase 0 trials, but several aspects of its language may bear on some of the ethical concerns discussed above.

Therefore, a subsequent article could explore how that language ameliorates or aggravates the concerns mentioned above.

* John Otrompke, JD, is a bioethicist and medical journalist. A graduate of DePaul University College of Law, with a certificate in health and hospital law, he was a 2015 faculty recruitment applicant at the Association of American Law Schools. He has never been engaged in the practice of law. He blogs at www.otrompkescommentaries.blogspot.com. He can be reached via email at John_Otrompke@yahoo.com

Notes

1. The author wishes to thank Prof. Barbara Evans, JD, PhD, of the University of Houston Law Center, and Prof. Seema Shah, JD, association professor at the Truman Katz Center for Bioethics at the University of Washington for their many helpful comments. Any errors are my own.

2 Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies (January 2006).

3 “Ethics at Phase O Clarifying the Issues,” J. Kimmelman, 35 J.L. Med. & Ethics 727 (2007). Prof. Kimmelman raised, but did not answer a number of such ethical questions. See also, “Phase 0 trials: a platform for drug development?”, editorial, The Lancet (July18, 2009), p. 176.

4 For exceptions, see: “Note: The FDA Clinical Trial Process: Effectuating Change in the Regulatory Framework Governing Clinical Trials to Account for the Historical Shift from ‘Traditional’ to ‘New’ Phase I Trials,” J. Aldest, 18 Health Matrix 463 (2008), pp. 474-477; “First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless,” R. Dresser, 37 J.L. Med. & Ethics 38 (2009), p. 39 et seq; “Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field,” L. Fatehi, 40 J.L. Med. & Ethics 716 (2012), p. 732-735; “Revising the Regulation of Stem Cell-Based Therapies: Critical Assessment of Potential Models,” B. Von Tigerstrom,  70 Food & Drug L.J. 315 (2015), p. 330.

5 Federal Register, Notice of Proposed Rulemaking, p 539334 (September 8, 2015)

6 “Regulatory Challenges of Synthetic Biology Trials and Other Highly Innovative Investigational Products,” L. Eckstein,  15 Macquarie L.J. 65 (2015), n.12.

7 “Position Paper on Non-Clinical Safety Studies to Support Clinical Trials with a Single Microdose,” EMEA Committee for Proprietary Medicinal Products (23 January 2003).

8 "Early Microdose Drug Studies in Human Volunteers Can Minimise Animal Testing: Proceedings of a Workshop Organised by Volunteers in Research and Testing.” Combes R, et al. 19 Euro J Pharma Sciences 1, pp 1-11 (2003).

9 See, for example, “Significant Changes to Institutional Review Boards Proposed,” J. Otrompke, IEEE’s Pulse Magazine, November-December 2012.

10 Guidance, supra n. 1 (p. 2, n. 4).

11 However, the guidance assumed that some exploratory studies might theoretically “induce pharmacologic effects.” Guidance, supra n.1 (p. 9).

12 Guidance, supra n.1 (p. 5).

13 Animal Research in Medical Sciences: Seeking a Convergence of Science, Medicine, and Animal Law,” J. Pippin, 54 S. Tex. L. Rev. 469 (2012-2013).

14 The author of this present article generally opposes animal testing, because even if it saves human lives, human beings do not adequately compensate the animals, individually or as a species, who are sacrificed.  

15 See, for example, “Research into a functional cure for HIV in neonates: the need for ethical foresight,” S. Shah, et al, Lancet Infect Dis. (2014 September).

16 FDA Amendments Act of 2007,  section 801. According to FDA, this regulation takes effect in January 2017. “The final rule considers all interventional clinical trials with one or more arms and with one or more pre-specified outcome measures to be controlled clinical trials.” Final Rule, Federal Register p. 64982 (Sept. 21, 2016).

17 Note 3, supra.

Note: The review of Prof. Greenberg's book was actually the second of my book reviews published by the ISBA recently. I thought readers might enjoy my review of Prof. Bob McWhirter's illustrated history of the Bill of Rights, which I wrote last year.

The citation is to the ILLINOIS STATE BAR ASSOCIATION’S HUMAN RIGHTS NEWSLETTER, VOL. 42 #1, SEPTEMBER 2015.

Bills, Quills and Stills offers something for everyone, but most of all the serious scholar

BY JOHN OTROMPKE

ABA Releases a New and Heavily- Illustrated Popular History of the Bill of Rights

Late in the first chapter of Bob McWhirter’s colossal and profuse new book, Bills, Quills, and Stills: An Illustrated, Annotated and Illuminated History of the Bill of Rights, the author makes a fascinating point about the interplay of the two main clauses of the First Amendment.

Pointing to the emergence of the internet, he says, “By any measure, we have more freedom of speech and religion today.” Continuing, he adds, ‘“The media’ seeks
to manipulate us every day, to influence who we vote for to the toothpaste we buy...We need something to help see the lines between the messages we get. That something can be traditional religion, a code of ethics, a philosophy, or principles by which to live. In this sense, even an atheist can have ‘religion.’”

After having read to the conclusion of McWhirter’s opus, a skeptic might propose an addition to that list: what about history?

In fact, McWhirter’s tome manages to combine a thorough and detailed history
of the origins of most of the Bill of Rights with enough scintillating images that almost anyone would want to pick it up, at least for a few minutes- a client in the waiting room of a law office, a junior high school student, teacher or judge- and it also contains such a thorough wealth of scholarly references that it will be of use to the scholar and the practicing lawyer as well.

McWhirter, a supervising attorney at a teaching law firm operated by Arizona State University, as well as an author and experienced litigator, got the idea for the book years ago, when he was assigned to give a presentation to the Arizona State Police and stumbled upon a 1937 reference by Nelson B. Lasson called ‘The History and Development of the Fourth Amendment to the United States Constitution.’

“I was going to write about the history of the criminal law amendments, such as the Fourth, Fifth, Sixth, and Eighth, which I actually use every day, and it became natural to write a book on the history of the Bill of Rights,” said McWhirter, a criminal lawyer who has also authored two books on immigration law.

One of the most interesting insights of the book is that Alexander Hamilton and other federalists believed the Bill of Rights was unnecessary and redundant: why would a federal government of limited powers (such interstate commerce, the suppression of piracy, etc.) ever try to restrict speech or the right to bear arms?

But those who drafted the Constitution knew that Anglo-Americans had taken
great pains over several centuries of English history to acquire a detailed legal history
in which certain rights were preserved, and Madison and others were intent on including them explicitly in the document.

While the first chapter of the book drags a little (sometimes it seems McWhirter is giving us a history of western civilization rather than the First Amendment), by the time he gets to the Second Amendment, the author more than makes up for it with a compelling recapitulation of English history, a wealth of scholarly footnotes, and an inexhaustible fount of imagery.


One is left with amazement at the reflection that some of these concepts (due process, for example) have survived the American Revolution and Civil War, and innumerable civil wars in England, and yet some laws remain unchanged and intact.

Sometimes McWhirter’s footnotes even touch on a topic that seems to compel literary research of its own, such as his argument, all too brief, that a proper understanding of the Fifth Amendment’s takings clause compels reparations for slavery, or that the concept of fundamental law is more rooted in natural law than English history, for example. (“Fundamental law is not just contractual; natural law is that which creates the greatest good,” he tells us, parsing the language of the Declaration of Independence as drafted by Jefferson and then edited by Franklin). While this volume may be too general to focus on a thorough development of such controversies, the serious scholar will find more than enough here to spark the idea for many a thesis.

That’s not to say that the book is flawless. The images can sometimes be distracting, and combined with the footnotes; they usually take up more than half the page. One may question some of the author’s well-established truisms; for example, the author quotes Pericles in the First Amendment chapter to tell us that “[H]appiness...[is] the fruit of freedom and freedom of valor,” but the history so expertly recounted in the rest of the book leads one to wonder if it is not wealth that leads to happiness, while bravery, at least for many of the English personages described by McWhirter, will only get you sent to jail.

Also curiously omitted was a history of the due process clause, at least 800 years old this summer with the recent anniversary of Magna Carta. The book concludes with a brief discussion of the Civil War Amendments (13th, 14th and 15th), which may have been a perfect place to discuss this seemingly all-encompassing concept of due process. But maybe McWhirter is saving such a discussion for a forthcoming volume (his next book, he tells us, will deal exclusively with the Civil War Amendments).

“I consider myself an originalist, but the intent of the framers of the13th, 14th
and 15th Amendments was very broad,” he says. “A lot of people say the framers never intended the constitution to do this, that, or the other. For example, maybe James Madison didn’t intend for you to pay federal income tax, but the framers of the 16th Amendment certainly did.”

All of that said, Bills, Quills and Stills remains one of the most physically gorgeous books ever published by the ABA. For schoolteachers, it is a natural go-to text; for the casual browser, its images and wit will be irresistible; and for serious readers, it is so well researched and annotated that it may find an eternal and irreplaceable slot on the shelves of your libraries or law office. 􏰁

I wrote the following review of Karen Greenberg's book, 'Rogue Justice,' this past spring. It was published in The Illinois State Bar Association’s Human Rights Newsletter, Vol. 43 #2, October 2016.

Book Review

‘Rogue Justice: The Making of the Security State’
Karen J. Greenberg
Crown Publishing, New York, 2016
$28 Hardcover

A Compelling Legal History of a Contemporary Civil Rights Catastrophe

Karen Greenberg’s ‘Rogue Justice’ is a Brief, but Encyclopedic Account of Modern Times 

by John Otrompke

It is a rude awakening to realize that, in the past 16 years, an entire generation in the U.S. has reached young adulthood, without ever knowing life before 9/11. They have lived only during the longest ‘war’ in American history, perhaps inured to a never-ending stream of public massacres. They have been told that Americans have lost our civil rights, but perhaps they can’t really know what that means.

Prof. Karen Greenberg, PhD, does an excellent job of providing a concise, compelling history of the legal aspects of this brutal, dystopian modern era. In ‘Rogue Justice: The Making of The Security State’ (Crown Publishing, New York, 2016), Greenberg, director of the Center on National Security at Fordham University School of Law, unwinds much of the entire narrative in 266 pages.

Every landmark event of this era finds its locus in the text: the 1998 African embassy bombings, the World Trade Center attacks, the passage of the PATRIOT Act, the invasion of Afghanistan, and the second invasion of Iraq . More recent phenomenon are also chronicled: Bin Laden’s killing, the Tsarnaev atrocities in April 2013, the release of the government’s report on torture, and the disclosures of Edward Snowden and Chelsea Manning.

To be sure, Greenberg is a historian, not a lawyer, although she teaches a course on national security issues and the law at Fordham Law School. She touches on almost each facet of the retrenchments in American civil liberties made in the past 15 years, with particular emphasis on the apparently universal secret surveillance, the torture policy, and, ultimately, the extra-judicial killing of American citizens by drones commanded by the president.

The work is unbiased, for the author is very unstinting in her criticism not only of the Bush, but of the Obama administration, too. This slim, well-researched volume also goes into the nitty-gritty of recent legal phenomenon such as indefinite detention without trial, growingly harsh punishments for whistle blowers, undisclosed use of surveillance evidence in criminal prosecutions, and even a body of secret law.

   An International Law Perspective Essential to Evaluating American Foreign Policy

In documenting these developments, Greenberg has given us an inside look at the official policy-shaping acts of influential lawyers inside the executive’s Office of Legal Counsel, and other branches of the federal government, new and old, through successive presidential administrations.  The author has developed this exhaustively-researched history through numerous interviews, personal observation of dozens of trials of jihadists, and even a personal visit to Guantanamo Bay.

Greenberg’s conclusion could be pithily summed up in her statement on p. 40 that the past era has constituted “an undeclared war being waged not on a particular enemy but on an idea, terrorism, which, like most ideas, is probably impossible to eradicate.”

While I admire Greenberg’s work, and respect her methodology, there are some changes I would like to see, should the book go to a second edition. First, while ‘Rogue Justice’ is a popular history rather than a legal text, she touches on enough matters of scholarly and practical interest that the book could use numbered footnotes and better citation to legal authority complying with Blue Book style. 

Additionally, there are several issues under international law, the inclusion of which could supplement Greenberg’s perspective. Shortly after 9/11, for example, some experts said that because Bin Laden was not alleged to be acting on behalf of a nation-state, but instead was international criminals, the U.S. was required to demand the trial or extradition of the perpetrators prior to invading Afghanistan (see, for example, “Legal Control of International Terrorism: A Policy-Oriented Assessment,” C. Bassiouni, 43 Harv. Int'l L.J. 83, (Winter 2002)).

Then, in 2003, there was the Bush administration’s violation of the U.N. Charter when France and other Security Council members disclosed their intent to veto the second Iraq war (“We don’t need a permission slip to defend our country.”) It seems that many of the world’s continuing problems stem from that oft-criticized invasion: ISIS, the deadly refugee catastrophe in Syria, perhaps even a fracture in the European Union.

     Foreigners May Prefer POW Status to Criminal Trial in Federal Court

Additionally, I disagree with one of Greenberg’s primary themes: that the federal courts are preferable as a locus for the trial of enemy combatants or jihadis, compared to courts martial. As Greenberg has written elsewhere:

            “These vexing issues could be far more readily resolved in U.S. federal courts, where  

           handling classified material under the Classified Information Procedures Act is a time-honored 

           and effective mechanism — and where judges have addressed the difficult issues involved in

           terrorism cases for three decades now. In fact, over 400 cases have been prosecuted in federal   

           courts since 9/11.”

“Those 28 pages on the Saudis, and these 5 trials of 9/11 plotters: Are we looking for closure in the wrong place?” K. Greenberg, New York Daily News, May 23, 2016 (editorial).

I doubt if a federal court would be more fair to certain jihadis than the military commissions she describes. As she describes it, the case of Ahmed Ghailani (p. 189) is a powerful illustration of this argument. 

Ghailani, indicted for a role in the pre-9/11 bombings of African embassies in 1998 in which 224 were killed, was tried not by a military commission, but before a federal court in the Southern District of New York. Although indicted on 285 charges, the jury convicted Ghailani of only one: conspiring to destroy property and buildings. He was not of any charges involving the deaths of human beings. Nonetheless, Ghailani was sentenced to life. But from a defense perspective, an act of war by a combatant arguably should not be prosecuted as a crime, unless it’s a war crime. Had Ghailani been treated as a prisoner-of-war, instead of a federal criminal defendant, arguably he could expect to go home some day.

Greenberg also describes another decision favoring a foreign combatant as retrogressive. The conviction of Salim Hamdan by a military commission for material support was  reversed by the D.C. district court after he had served his sentence and been released (p. 248). The federal court found that Hamdan could not be convicted of material support, because that was not a crime when the acts in question took place, long before 2006.  

Greenberg says that the 2012 decision “threatened to bring [progress] entirely to a standstill...The military commissions were not only failing to make forward progress; they appeared to be on the verge of moving backward.” 

The author tells us that today, these cases (when tried) are almost always brought in federal court. But I have grave misgivings about the expanding assertion of universal criminal jurisdiction by U.S. federal courts, especially when the U.S. has repeatedly refused to recognize the universal jurisdiction of other international bodies.  

       Americans Can Be POWs, but POWs Have Habeus Corpus Rights

Perhaps what Prof. Greenberg is concerned about is the prospect of American dissidents being tried by military commissions. After all, Greenberg describes several other recent manifestations of executive totalitarianism, such as surveillance, torture, and extrajudicial disappearances, as well as international aggression.

As a bit of backstory, perhaps one reason that fear has not come to pass (at least not yet) has to do with a series of decisions by the Supreme Court, which, when it has acted at all in recent years, has generally issued opinions supporting principles of humanism and fairness in this context.

As Prof. Greenberg notes, the Supreme Court first held that an American cannot be tried by a military court in the civil war-era case Ex parte Milligan (p. 89). But the High Court reached a different decision during World War II in Ex parte Quirin (p. 65), which was distinguished from Milligan because the Americans being tried by military commission in Quirin had actually been a formal part of the German army.

But a different issue is presented, as Greenberg says, by the important question of whether federal courts have any habeus corpus jurisdiction over POWs at all. Many years ago, the Supreme Court told us no, in the World War II-era case of Johnson v Eisentrager. The individuals in Eisentrager (who were not Americans) could not avail themselves of federal habeus corpus review, because jurisdiction only lay in courts in the jurisdiction in the which prisoners are located. 

So why do federal courts have jurisdiction over POWs today? The principle of Eisentrager was overruled, the Supreme Court told us in Rasul v Bush, by a rather esoteric Supreme Court case from 1973, called Braden v 30th Judicial Circuit Court of Kentucky, which did not involve prisoners-of-war. In Braden, the Supreme Court ruled that a habeus petition can be brought in any district court in which  the custodian can be served, regardless of the location of the prisoner.

That is how foreign combatants came to have access to the great writ: in an act of legal jiu-jitsu, the Supreme Court relied on an obscure 1973 opinion, authored by Justice Brennan, to protect human rights in the midst of the civil liberties catastrophe that followed in the wake of 9/11.

        An Unprecedented Expansion of Freedom in the 21st Century

So for young adults, how has life changed in the U.S. since the PATRIOT Act? Surprisingly, in many ways, Americans are far freer today than we were in 2001. 

In the past era, there were no LGBTQ rights under the U.S. Constitution. Cannabis was universally criminalized here, and the Second Amendment was not thought to protect an individual right to own a firearm. While massacres in the U.S. have become a phenomenon of appalling recurrence and regularity, they have been most often committed by Americans. 

In short, as a matter of visible law, many Americans have been seeing an unprecedented expansion, not a contraction, of our civil rights. This contrasts with the experience of many generations in the Middle East, going back to the period after World War I, for whom American foreign policy was often anything but a boon.

Developments since 2001 make it clear that radical change can be effectuated in the federal courts. When it has acted at all, the Roberts Court has often acted to promote human freedom, sometimes in surprising ways. But a foreign combatant might prefer prisoner-of-war status to a trial in a federal court.

‘Rogue Justice’ is a gripping account of a true history which moves through the history of the past 15 years with the energy of a whirlwind. While I may disagree with one of her themes, Greenberg’s diligent research has made a significant contribution to the legal history of current events.

(c) 2016 John J. Otrompke, JD

One Method of Researching Child Suicides, the Psychological Autopsy, May be Hindered by the Common Rule and IRB Requirements

Child suicides in the U.S. are increasing, yet research is hampered by low incidence and high fluctuation. One method of research, the psychological autopsy (involving interviews of the deceased child's family members) may not be available for universal application due to IRB requirements. This could make it more difficult to understand what is causing an increase in suicides among very young children.

This article, based on a poster at a recent meeting of the American Academy of Child and Adolescent Psychiatry, first appeared on my journalism blog.

I am very interested to explore whether the proposed changes in the notice of proposed rulemaking to the federal Common Rule would effect this regulatory hurdle.

Apeus Corpus Proceedings

Will an Oregon Court be the First American Tribunal to Grant a Habeus Corpus Petition for an Animal?

by John Otrompke

A recent animal neglect opinion from the Supreme Court of Oregon raises the question of whether that state might be an ideal venue for a new “apeus corpus” petition, that is, a test case to establish a rule granting animals a right to habeus corpus relief.

The question arises in the context of an unsuccessful habeus corpus petition brought on behalf of a chimp in New York state in 2014, as well as a habeus corpus argument made on behalf of an orangutang in Argentina in a case with an outcome that is not yet entirely clear. Both cases, however, gave rise to potent language in dicta that could encourage reworked petitions in the future.

Such language is profuse in Oregon case law, although the Nonhuman Rights Project, which brought the New York case, has said that the state is not on the Project’s short list of favorable venues.

But important legal precedents are often as much a product of inspiration and profound philosophical meditation as they are of rote application of pre-existing legal precedent. Therefore, notwithstanding the negative precedent (no third party right to bring habeus corpus petition) thought by the Project to have been established in the 1996 Oregon case of Bryant v. Thompson, a careful analysis supports odds favoring Oregon as a potential first state to make history by granting habeus corpus relief to an animal.

Importantly, while the recent opinion, Oregon v Newcomb, is interesting, it has been commented on by scholars, and past cases from Oregon are even more powerful, and so they will be alluded to below.

Newcomb and Its Antecedents, such as Nix and Hess

The Oregon case, published this past June, was not a petition for an animal’s freedom, but a criminal proceeding for animal neglect, which involved issues of search and seizure law as it applies to human criminal defendants.

However, it was part of a series of such opinions from the Oregon Supreme Court which may hold significance for animal habeus corpus cases. The most powerful language of these cases is from Oregon v Nix, a 2014 case involving emaciated horses and goats on a farm, which is discussed below.

The 2016 Oregon case, Oregon v Newcomb, 359 Or 756 (2016), involved a charge of second degree animal neglect when the defendant (a human) failed to properly feed her dog, Juno. The opinion featured much analysis of search and seizure and privacy law under the Fourth Amendment and Oregon law, but ultimately concluded that the defendant did not “have a protected privacy interest in her dog’s blood.” While the Oregon Supreme Court noted that pet animals are personal property, the defendant had no protected privacy interest in the dog Juno’s blood, because the veterinarian who drew the blood did so to provide apparently needed medical care to Juno (as mandated by state law). Newcomb at 770.

The court noted, “Oregon’s animal welfare statutes impose one of the nation’s most protective statutory schemes...[reflecting] the recognition that animals “are sentient beings capable of experiencing pain, stress and fear.” Id at 767.


Intriguingly, the Oregon Supreme Court also repeated past language: “As we continue to learn more about the interrelated nature of all life, the day may come when humans perceive less separation between themselves and other living beings than the law now reflects. However, we do not need a mirror to the past or a telescope to the future to recognize that the legal status of animals has changed and is changing still.”

Powerful Language that May be a Bridge to Rights Recognition

Aspects of the Newcomb case have been recently commented on by other scholars, such as its search-and-seizure analysis, its weight as a poverty law case, and its fundamental assumption that animals are property.

What I want to talk about is two prior Oregon cases, Oregon v Nix, and Oregon v Hess, in which the Oregon Supreme Court engages in an extended discussion of animal rights which raises in my mind the possibility of more profound achievements in this field in an Oregon forum. (The latter case, Hess, is even more problematic from a criminal law perspective, because it involves an especially contorted and bizarre line of reasoning regarding the insanity defense).

The case with the more important reasoning was Oregon v Nix, 355 Or 777 (2014), which was later vacated because the state failed to preserve for appeal the essential argument: that each animal in an animal neglect or cruelty case is a separate victim. Oregon v Hess, 273 Or App 26 (2015), merely embraced that holding of Nix and made it binding. Other than that, Hess (a cat hoarding case which involved convictions for seven counts of first-degree animal neglect and thirty-eight counts of second-degree animal neglect) did not break any new intellectual ground, except for its seemingly Escher-esque analysis of the insanity defense (held inapplicable, because while the defendant may have acquired cats due to obsessive-compulsive disorder, it was said to be her poverty, not her OCD, which prevented her from properly caring for them).

(Indeed, anyone who has ever had to report their neighbor, friend, relative or loved one because they were unable to feed a non-human animal knows that it is an odious task; and one is left with the troubling question of whether the case resulted in a favorable outcome for the non-human animal).

Therefore, I will spend a little more time discussing Nix. That case, which upheld a conviction for 20 counts of second-degree animal neglect, doesn’t seem to fit the typical mould of a poverty law case, but involved the neglect of numerous horses and goats on a farm.

What is really interesting about Nix is its extended discussion of animal cruelty legislation. Starting with the Puritan Body of Liberties (1641), the court traces an evolving standard from New York’s 1867 statute (ch 375, § 1) and Oregon’s law in 1885. The Model Penal Code of 1962 included a provision protecting animals from cruelty (s. 250.11) which was incorporated into the new Oregon criminal code of 1971 (later overhauled in 1985). Nix, p 791- 797 (also citing eight law review articles and other sources).

Rights and Personhood are Not Recognized (but are Suggested)

Ultimately, the court relies on the sources to conclude that the Oregon anti-merger statute means that a ‘victim’ for the purposes of the animal neglect and cruelty laws is neither the community at large, nor the animal’s owner, but each individual animal.

Along the way, the Nix court addresses the question of whether an animal is a ‘person,’ noting that the statute “itself provides a definition of ‘victim’ as ‘the person or persons who have suffered financial, social, psychological or physical harm as a result of a crime.’” Nix at 878.

However, the Oregon Supreme Court seems to think that an animal is not a person (but concludes that a ‘victim’ under the animal neglect and cruelty laws need not be a ‘person’), in part because “provisions relating to the rights of victims to appear in court, to obtain restitution, and to be heard at sentencing and Parole Board hearings would be difficult to apply were 'victims' to include non-human animals.” Id.

Indeed, the court does not phrase its outcome in terms of animal rights (to habeus corpus or otherwise) at all: “In concluding that animals are ‘victims’ for the purposes of ORS 161.067(2), we emphasize that our decision is not one of policy about whether animals are deserving of such treatment under the law. That is a matter for the legislature.” Nix at 798.


Recall that the effort to convince a court that a non-human animal can be a non-human person with rights (like a corporation, a Hindu statute, the sacred text of Sikhism, or a river in New Zealand, for example) is important to the strategy of the Non-Human Rights Project, which has said that Oregon is not on its short list for bringing such a proceeding (which I dub a writ of ‘apeus corpus’).

I believe that what happens next in Nix, however, is informative. Then the court turns to cases including State v. Hamilton, 348 Or 371, 233 P3d 432 (2010), an armed robbery case in which each person present during a robbery was held to be a separate victim (regardless of whether or not they were individually robbed). And along the way, the Nix court cites another ten sources, including John Stuart Mill, Rachel Carson, and another three law review articles, at pp. 782-784.

The Nonhuman Rights Project, which brought a habeus corpus petition on behalf of a chimp named Tommy in New York in 2014, has noted in previous research that while Oregon is a favorable venue for an animal habeus corpus case in the sense that the state recognizes a common law right to normative equality, Oregon’s law regarding third party habeus corpus powers is less favorable, and therefore, the state is not on the Project’s short list of favorable venues.

My point is simply this: although the Oregon Supreme Court seems to suggest that the legal status of animals as enjoying rights is not inherent or judge-created, but determined by the legislature, the court’s lengthy and elaborate analysis suggests to me that the court is ripe to change its mind.

After all, for how many years and in how many ways following Romer v Evans did the SCOTUS hold that  while there is no locus for gay freedom and equality in the U.S. Constitution, nonetheless a state could not preclude a legislature or its subdivision from seeing things the other way? And just last year the Supreme Court said, “Remember when we said all those times that there are no LGBTQ rights under the U.S. Constitution...Well, we’ve changed our mind.”

Shades of Ichabod Crane: Scalia’s Ghost Rides Again!

Shades of Ichabod Crane: Scalia’s Ghost Rides Again!

CA10‘s Refusal to Decide Polygamous Cohabitation 

Issue Possibly Tainted by Substantive Opinions

A decision from a federal court of appeals last month illustrates the serious obstacle that standing sometimes presents to federal constitutional plaintiffs outside of the free speech context. The Tenth Circuit reversed the district court’s opinion, which had granted thepolygamous plaintiffs relief and declared a Utah law against cohabitation unconstitutional.

Perhaps more interestingly, however, the opinion may illustrate the relatively plastic nature of the “standing” doctrine which so often “stands” as a barrier to relief in these cases, because one may speculate (as the author of this blog does herein) that the Tenth Circuit panel was influenced as much by unspoken skepticism regarding the constitutional claims made my the plaintiffs as they were by that jurisdiction’s ideas about standing.

Notably, the law challenged in the case could be described in legal jargon as “a law of general application,” meaning that it did not appear to single out anybody’s viewpoint or religion for discriminatory treatment; nor did it explicitly create any restrictions on speech.

The district court opinion in the case, Brown, Sullivan, et al v Buhman, 14-4117 (CA 10 2016), had been foreseen by the late Justice Antonin Scalia as a logical consequence of the Supreme Court’s recent landmark opinions on gay freedom and equality. 

But in reversing, the federal appeals court panel may have reasoned that the relief that plaintiffs were given in the district court by the defendant law enforcement agencies (an enforceable promise not to enforce the law being challenged) was much more protective to the plaintiffs than the likely decision the panel would issue, had they decided the case. (I assume the panel would have held that there is no right under the U.S. constitution to live together as a spiritually polygamous family). 

Therefore, the panel may have reasoned, the plaintiffs had nothing to complain about. For that reason, the panel may have been more inclined to stretch to find a lack of standing. 

The case was filed under 42 USC 1983 by Kody Brown and his companions, the stars of the famous reality television series, ‘Sister Wives.’ The complaint alleged that upon the airing of the series, local law enforcement officers in Lehi, Utah “opened an investigation of” the plaintiffs in 2010. It seems that after scary comments were made by law enforcement agents, the plaintiffs moved to Nevada in 2011. 

The Browns and companions sought relief in the local district court, challenging Utah Code § 76-7-101 (1): “ A person is guilty of bigamy when, knowing he has a husband or wife or knowing the other person has a husband or wife, the person purports to marry another person or cohabits with another person.”

According to the Court of Appeals, the case suffered from “mootness” (a doctrine related to standing), because the Utah Attorney General has a pre-existing policy against initiating prosecutions for Mormon cohabitation in the absence of abuse, fraud or other crimes. The local attorney general created a similar policy while the case was pending in the district court. 

Importantly, the Tenth Circuit said, both law enforcement policies were accompanied by affidavits filed in federal court and sworn under penalty of perjury, and, if necessary, the federal courts could enforce them using federal laws like 18 U.S.C. § 401(2) to sanction the individual officials who were being sued, either for perjury or by entering punishments such as a fine or imprisonment for “misbehavior.”

Now let’s examine some reasons that the panel might have reached a contrary result.

First, let me reiterate that this was not a challenge to a law which implicated free speech on its face. In such cases, the requirements of standing are greatly relaxed. Instead, as mentioned above, Utah Code § 76-7-101 is “generally-applicable”: it neither singles out any religion or viewpoint for disparate treatment, nor does it appear to proscribe speech, at least not at first glance. 

Because the challenged statute was treated as a state law “of general application,” the plaintiffs also had a harder time challenging it as a burden on their religious beliefs. If instead they were challenging a federal law, the federal government would have to show a compelling interest in upholding the law, because in creating the Religious Freedom Restoration Act (RFRA), Congress voluntarily limited the application of its laws when they impose a substantial burden on an individual’s religious beliefs, even if the law in question is one of general application.

But the Supreme Court has held that RFRA does not apply to the states, because RFRA is not required by the Constitution, and Congress lacks authority to impose it on the states (like Utah).

What this means is that Mormons do not have a right under the federal constitution to live together in spiritually polygamous cohabitation, unless everyone has that right. Theoretically, it seems, the plaintiffs in the case could have argued that even though the law looks generally-applicable on its face, it had previously been applied in a discriminatory manner. But the court of appeals engaged in a cursory, desultory discussion of that question, and suggested that the state’s description of its policies was made in good faith.

The court also said that because the complaint described an alleged past injury (the plaintiffs’ move to Nevada), they could have brought a damages action. That might have forced the constitutional issue, but the court said the plaintiffs chose not to do so.

So what arguments for finding standing did the Tenth Circuit overlook?

For one thing, the appeals court stretched the facts a little bit, by crediting the declaration of Kody Brown (“[w]e have decided to stay in Nevada in the foreseeable future”), and giving less credence to that of Janelle Brown, who declared “that were the statute declared unconstitutional, the plaintiffs ‘would certainly resume [their] open participation in [their] religious community’” in Utah. Apparently the Tenth Circuit decides who wears the pants in the Brown household.

The court also stretched the law a little bit. It was important to the appellate court panel that the dismissal was not on the merits, and without prejudice, because while any future law enforcement officers were free to change Utah’s policy regarding enforcement of § 76-7-101, “any steps to reconsider would almost certainly provoke a new lawsuit[.]”

Perhaps the court was being a little disingenuous in that regard, however; if the Utah authorities were somehow to decide to prosecute the plaintiffs, imagine what difficulty the household would have in ever getting the case back into federal court. A host of preclusion doctrines would prevent the federal court from interrupting criminal proceedings that had already been initiated. While there can be a federal habeus corpus action, it only lies while an individual is still imprisoned, and after they have exhausted state avenues of relief. Were they to be prosecuted, the plaintiffs would be unlikely ever to get their case heard in federal court, unless the state judge were to impose a relatively long sentence.

So what could have biased the court of appeals in favor of holding that the plaintiffs lacked standing in the case? The court explained that “voluntary cessation” of a practice can make a case moot, but only if the government bears the “heavy burden” of showing it has no desire or intention to return to “the old ways.” 

The heart of the plaintiff’s grievance was an argument that individuals enjoy a due process right “to freely make personal decisions relating to procreation, contraception, family relationships, and child rearing,” as well as an argument about vagueness. But as I mentioned above, the Tenth Circuit may have held an unspoken opinion that there is no such constitutional right to spiritually polygamous cohabitation. 

In fact, the Supreme Court held in Reynolds v. United States, 98 U.S. (8 Otto.) 145 (1878) that there is no constitutional right for Mormons to engage in religiously- motivated polygamy. But Mr. Brown and his companions did not apply for or hold marriage licenses. What about mere cohabitation? 

No right for consenting adults to live together, you say? Believe it or not, the Supreme Court has never decided that issue. The court came close in McLaughlin v. Florida, 379 US 184 (1964), in striking down a law proscribing interracial cohabitation, but also explained that the holding was rooted in equal protection, not a liberty interest. See also Cleburne v. Cleburne Living Center, 473 U.S. 432 (1985) (denial of special use zoning permit to group home for the mentally retarded was a violation of equal protection).

But everybody’s doing it, right? It seems that a constitutional right of adults to live together is simply one of those issues that the court has transcended, without ever actually deciding it, perhaps because it has come to seem so obvious. 

Nonetheless, polygamy was listed among a parade of horribles cited as a justification for upholding anti-gay laws by Justice Scalia in his dissent in Lawrence v. Texas, 539 US 558 (2003). Perhaps that alone made the Brown case more controversial for the Tenth Circuit.

For an example of another lovestyle which a federal court recently held was not protected by the U.S. Constitution, see Doe v Rector and Visitors of George Mason University, 1:15-cv-209 (D.C. VA 2016) (no right to engage in consensual S&M under U.S. Constitution).

John Otrompke, JD, a graduate of DePaul University College of Law, and a 2015 AALS FAR applicant, may be reached at John_Otrompke@yahoo.com

In Pastafarianism Case, the Nebraska District Court Discriminates 
Against Irreligion, Setting a Dangerous Freedom of Religion Precedent

A freedom-of-religion decision issued this month by the U.S. District Court for Nebraska seems to have discriminated against irreligion and in favor of religion by refusing to extend religious rights to a prisoner who claimed to adhere to the ‘Pastafarian’ religion of the Flying Spaghetti Monster.

Unfortunately, the opinion is a step toward engraving into law a principle often expressed by the late Justice Antonin Scalia: that the constitution does not prohibit the government from favoring religion over non-religion. The only difference is that in this case, it is not non-religion which is disfavored- but irreligious satire. I take issue with all of these conclusions, and posit that the decision should be reversed.

In justifying the holding, district court Judge John M. Gerrard seemed to rely on two logically incompatible conclusions: that the inmate, Cavanaugh, had no sincere religious belief in the Flying Spaghetti Monster, and that any religious practices he wanted to engage in had not been burdened.

Importantly, the court also suggested in several places that poor pleading by the pro se plaintiff justified the result, because it showed that Cavanaugh’s claims to religious belief were insincere. 

The judge’s decision is all the more puzzling because he recognizes that atheism and out-of-mainstream religious practices qualify as religions for purposes of the law, for which proposition the court produces an prodigious bibliography of legal authority. In fact, the court expressly mentions unorthodox religious beliefs described in two novels, Stranger in a Strange Land (Robert Heinlein, 1961), and Cat’s Cradle (Kurt Vonnegut, 1963).

But when it comes to Pastafarianism, the court puts its foot down, describing it as a mere parody of intelligent design theories, “intended to advance an argument about science, the evolution of life, and the place of religion in public education.”

The opinion, issued April 12, dismissed the case, Cavanaugh v Bartelt, which was a section 1983 action in which the prisoner sought to compel the prison authorities to extend him “the same rights and privileges as religious groups, including the ability to order and wear religious clothing and pendants, the right to meet for weekly worship services and classes and the right to receive communion.’”

Even though the plaintiff did not mention the most relevant statute, the court analyzed the question under the Religious Land Use and Institutionalized Persons Act (RLUIPA), which is broader than the First Amendment, since, like the Religious Freedom Restoration Act (RFRA), it restricts the government from imposing a law of general applicability so as to substantially burden an individual’s religious practices, unless it passes strict scrutiny. Unlike RFRA, however, RLUIPA applies to the states, because it applies to all states that receive federal funding for prisons, and all states do. 

The court also took pains to learn about Pastafarianism, so that the judge could “liberally interpret” the prisoner’s complaint, and traced the historical development of this practice from 2006 (The Gospel of the Flying Spaghetti Monster, Bobby Henderson).

Courts must not presume to determine the plausibility of a religious

claim, the court reminds us, citing Burwell v. Hobby Lobby Stores. But RLUIPA does not apply when the individual has no sincere religious beliefs that could be burdened.

“This case is difficult,” the court wrote, because Pastafarianism does not “advocate for humanism or atheism,” which would be a religion for purposes of RLUIPA. “The only position it takes is that others' religious beliefs should not be presented as ‘science.’ Despite touching upon religion, that is a secular argument,” the court wrote.

Clearly the court is partly correct, but the decision is nevertheless wrong. Pastafarianism does smack of satire rather than religious belief, but

there seems little doubt that the disrespectful opinion of adherents toward religious belief is sincere. Pastafarianism’s irreligiosity should be entitled to the same respect as sincere religious beliefs. The government should have no power to favor religion over irreligion. 

Satire has historically been a powerful way to criticize beliefs of all kinds, so imprisoned individuals should be as free to gather in prison to satirize religion, as others are to sincerely practice religion. Extending such rights to them might even give them the moral strength necessary to continue on with their disbelief.

The court justified the decision by a second conclusion which was logically irreconcilable with the first: Cavanaugh had not shown how any beliefs he held had been substantially burdened. 

The court again complained about poor pleading, explaining that from the pro se complaint, “it would be impossible to tell what he had actually asked for, or why, or anything about his purported beliefs other than their name....Cavanaugh has not alleged anything about what it is that he actually believes—leaving the Court to read the book.”

However, The court decided that it would be pointless to allow the prisoner to amend his complaint.

Adding to the satire, the court interpreted the complaint as seeking relief that would allow the prisoner to dress like a pirate. It seems possible that a rule prohibiting inmates from dressing like pirates would pass strict scrutiny, though the test is sometimes rephrased as ‘strict in theory, fatal in fact.’ On the other hand, if the RLUIPA did guarantee prisoners the right to dress like pirates, and engage in other behavior the Cavanaugh court found objectionable, that may be a statutory issue for Congress o decide.

Perhaps the prisoner might be permitted to wear a small patch of a parrot on his prison shirt; and spaghetti dinners likely occur in the institution on a regular basis anyway. Permitting incarcerated Pastafarians to gather periodically seems like a rather legitimate way of encouraging people to question their religious beliefs and values.

In short, the opinion discriminated in favor of religion, and against irreligiosity. The religious beliefs of the plaintiff may not be sincere, but surely the disbelief of Pastafarians in religion is as sincere as any conviction. 

It seems the opinion would likely make the late Justice Scalia pleased on the other side of the veil (unless, indeed, Justice Scalia found himself disappointed when he crossed over).

Hopefully, higher courts will reverse this extremely dangerous precedent.

John Otrompke, JD, a graduate of DePaul University College of Law, and a 2015 AALS FAR applicant, may be reached at John_Otrompke@yahoo.com

All contents (c) 2016 John J. Otrompke