All contents (c) 2017 John J. Otrompke, JD

Reverend Martin Luther King Day and Beyond

                              A Constitutional Meditation on Meta-Pacifism

by John J. Otrompke, JD

The Reverend Martin Luther King, commemorated every year on the third Monday in January, should be honored even more than he is. Works are more beneficial than faith, which sometimes is even counterproductive. Activists with universal ideals are inheritors of Rev. King’s legacy, and there are a number of ways we could better honor his memory.

      One thing judges could do to honor Rev. King is to abolish the collateral bar rule in First Amendment cases, which contradicted almost 30 years of Supreme Court decisions when it was devised specifically for Dr. King following his ‘Letter from a Birmingham Jail.’

      The collateral bar rule lingers with us even today, and continues to systematize the perpetration of injustice; today, it figures prominently in many cases where an individual’s speech is restricted by a court-issued injunction.(1) (It comes into play perhaps most commonly in ‘order of protection’ cases).

While orders of protection restrict speech, they also restrict another important right, the right to possess arms. Debaters on both sides of the arm issues often base their contentions solely on policy and its results, but both sides miss an important point. Since King’s death, a new problem with violence has emerged in our society:  massacres of schoolchildren have become commonplace, and we as a society can’t know for sure how to solve that problem, because we have never before confronted it. 

As a second way to honor Rev. King, both sides of the debate about guns might humbly admit that their contentions as to the likely policy effects of their views can only be theoretical, because we as a society have never experimented with gun abolition and gun freedom in a systematic way. 

We should continue to experiment with gun freedom, to learn whether that policy is capable of solving our problem with atrocities. At the same time, however, we should recognize that a trial-and-error method may be necessary. 

Although I believe gun freedom is a part of the Constitution, I subscribe to a position I call “meta-Pacifism”; that is, I believe it is possible that human beings may one day abolish violence, and I believe in working toward that.

Out of respect for Rev. King, I elaborate on these ideas below, and conclude that if the reader appropriately him, you should act on his principles, rather than commemorate him passively. 

                              The First Amendment and the Collateral Bar Rule

Rev. King made immense contributions not only to civil rights and peace, but to a more generalizable strategic philosophy of idealistic personal activism in the face of injustice. 

As has been told elsewhere, in early 1963, a group of civil rights activists (including Dr.. King, Rev. Fred Shuttlesworth and Wyatt Tee Walker) began a campaign to end racial discrimination in Birmingham, Alabama. 

      In April of that year, the Birmingham chief of police obtained an ex parte injunction against the marches. Some of the protesters, notably Dr. King and Walker, 

reasoned that if they were to permit the forces of segregation to tie them up in court for years at a time, there may never be a civil rights movement. They stated: "We are now confronted with recalcitrant forces in the Deep South that will use the courts to perpetuate the unjust and illegal systems of racial separation." Therefore, the activists decided to defy the injunction. 

Rev. King and Walker were arrested, charged with contempt, and imprisoned.  While he was in jail, King wrote ‘Letter from a Birmingham Jail’ (1963), a classic work of American political philosophy, to which the entire country pays homage on Rev. King’s holiday.

The Supreme Court upheld the contempt convictions of the protesters, including King. (2). (Among those voting to uphold the imprisonment of Rev. King was Justice Hugo Black, a former enthusiastic Klansman who today enjoys an undeserved reputation as an absolutist civil libertarian).

      In Walker v Birmingham (3), the U.S. Supreme Court concluded that Dr. King and Walker were barred from raising the First Amendment as a defense to the contempt charge on which they were imprisoned, because they did not litigate and appeal the ex parte injunction. In so doing, the Supreme Court adopted a principle which contradicted almost 30 years of First Amendment opinions.(3)

In Cantwell v Connecticut, (4) for example,  the Court said, “[T]he availability of a judicial remedy...in the system of licensing still leaves that system one of previous restraint [and] inadmissible...[P]revious restraint...by judicial decision after trial is as obnoxious to the Constitution as one providing for like restraint by administrative action.” And in Lovell v Griffin (5), the Supreme Court said, “[I]t was not necessary for [the speaker]

to seek a permit under [the statute]. She was entitled to contest its validity in answer to the charge against her.”

Prior to the contempt charges against Rev. King and Walker, the guiding free speech principle in injunction cases went hand-in-hand with the overbreadth doctrine, which was just being developed in those years. Up until Walker, overbreadth was supposed to be like kryptonite: nothing, absolutely nothing, gets through it. 

Prior to Dr. King, the Supreme Court of the era presumed that a law that explicitly restricts speech because of its content has a chilling effect. Free expression was deemed so important, prior to the Walker case, that the Court would prioritize judgment against an unconstitutional law. The court would be unwilling to allow it to fester for very long on the statute books for the lack of a plaintiff willing to assume the risk and trouble of having it declared unconstitutional. 

After Walker, the First Amendment does not protect speech engaged in in violation of a court order.

(What remains of the overbreadth doctrine today? Maybe nothing, if a lawyer doesn’t file a motion to reconsider).

About two years later, the Supreme Court held the same Birmingham ordinance unconstitutional in the case of King’s fellow activist, Rev. Shuttlesworth.(6) (See also Shuttlesworth v. City of Birmingham, 382 U.S. 87 (1965), another case from the Supreme Court which set aside a conviction of Rev. Shuttlesworth from a demonstration which took place a year earlier than the march which led to the Walker case).

In a moment, I’m going to talk about the collateral bar rule as it sometimes applied today. But first, let’s take another look at the Walker-Shuttlesworth-Shuttlesworth trio of cases again, this time in slow-motion. 

One reason the Warren Court may have felt less guilty about affirming King’s contempt conviction was that the Birmingham statute was about to be declared unconstitutional anyway, in Shuttlesworth.(7). 

But if the reason that Rev. Shuttlesworth still had the power to challenge the constitutionality of the Birmingham ordinance was because he chose to litigate the injunction, instead of marching in violation of it with King, Walker and the others (8), then how did Rev. Shuttlesworth get arrested?

Indeed, the Supreme Court opinion itself tells us that during the Good Friday march on April 12, 1963, the demonstrators “were led out of a Birmingham church” by three ministers, including Rev. Shuttlesworth, who “was with the group for at least part of this time, walking alongside the others, and once moving from the front to the rear.” Shuttlesworth 394 US at 148-149.

And in the Supreme Court’s earlier Shuttlesworth case from the demonstration a year before, on April 4, 1962, the opinion notes that Rev. Shuttlesworth was arrested when he was “standing on a sidewalk with 10 or 12 companions outside a department store.” Shuttlesworth, 382 US at 89.

Clearly, then, Rev. Shuttlesworth was at the Good Friday demonstration in 1963. Some scholars try to distinguish Shuttlesworth from Walker by finding an exception to the collateral bar rule for activity which is closer akin to “pure speech,” uncombined with some other physical activity, such as marching.(9)

Indeed, the Supreme Court seemed to partially embrace this view in Walker itself: “"We emphatically reject the notion . . . that the First and Fourteenth Amendments afford the same kind of freedom to those who would communicate ideas by conduct such as patrolling, marching, and picketing on streets and highways as these amendments afford to those who communicate ideas by pure speech." Walker at 316 (citing Cox v. Louisiana, 379 U.S. 536, 555 (1965)). 

But what’s really going on here? Is the Supreme Court really trying to tell us that although Rev. Shuttlesworth was arrested at the site of the march, he was not actually marching? Or is the discrepancy in this trio of cases just a distinction without a difference, another Supreme slight-of-hand? If so, that’s all the more proof that the collateral bar rule should be abolished. 

                              Gun Rights and Gun Policy

The Birmingham ordinance was eventually declared unconstitutional by the U.S. Supreme Court, but the effects of the ‘collateral bar rule,’ the special procedural rule created for Rev. King, linger with us today. The rule is generally applied in First Amendment cases involving injunctions, but perhaps most commonly in order of protection cases in domestic violence court. 

Respondents in order of protection cases are not guaranteed the right to counsel until after they have accidentally waived all of their rights. The right to counsel does not attach until the criminal phase of the bilateral order of protection proceedings, that is, after the respondent has violated the protective injunction, at which point counsel is worthless, because Walker establishes that they have already lost the opportunity to raise most constitutional defenses, including the First Amendment.

The Supreme Court allowed the Birmingham ordinance to remain in force for only a few years following Dr. King’s arrest, But for how many years have defendants been imprisoned in order of protection cases in violation of the First Amendment? 

Today, the trap created by the collateral bar rule adopted for King allows savvy legislators to avoid inconvenient constitutional protections merely by crafting laws that lend themselves to bilateral proceedings. But to countenance a law that systematically deprives untold numbers of individuals of their constitutional rights is deplorable.

Another right affected by order of protection laws and their injunctions is the right to keep and bear arms.(10) Since this essay is intended to make a contribution to the project described by Dr. King, a reflection on issues related to arms seems appropriate.

      Note that while order of protection laws claim to have a legal effect on the arms right, the question of whether they can do so without violating the Constitution is still up for grabs. Voisine v US (2016), a recent opinion from the Supreme Court that is related to the issue of arms in the context of domestic violence, was widely misinterpreted in the press. 

In fact, the Court’s decision in Voisine concerned only the proper interpretation of a federal law; the Court neither considered nor decided whether the law violates the Second Amendment. (The Supreme Court granted certiorari only as to the issue of statutory interpretation, not the constitutional issues). The opinion in Voisine concluded that the law in question, 18 USC §922(g)(9), should be interpreted to mean that an individual convicted of certain reckless domestic violence misdemeanors would be permanently deprived of their right to own a firearm. 

      Attentive readers will recall that the issue of criminal liability in unintentional domestic violence-related circumstances was also at the heart of the Court’s recent opinion in Elonis v US (2014). In that case, the Court noted that the Constitution disfavors a law that criminally punishes an individual for unintentional acts which were merely negligent, but left open the question of whether criminal punishment could lie for unintentional acts which were reckless. 

Today, the right to bear arms described in the Second Amendment is authoritatively considered to belong to individuals (not merely government militias), and it is likely to remain so for the foreseeable future. I believe that as a matter of constitutional interpretation, that view is correct for two reasons.

First, much of the entire Constitution is founded on a revolutionary vision of a society in which the people defend themselves, without misguided reliance on a standing army operated by the government. (The vision of an enlightened society without a standing army vanished from American constitutional history almost as quickly as it appeared. I believe that its absence has been at the root of much mischief in American foreign policy, and of much of what I find objectionable about American society).

The second reason I believe the Constitution makes the right to bear arms personal is that the Second Amendment descends from the English Bill of Rights (1689), which was informed by historic violence between Catholics and Protestants in England. The Second Amendment is designed to allow people to defend themselves from the government, their neighbors, and others.

But when, in contemplating questions of arms, our attention shifts from the constitutional point-of-view to a policy perspective, different conclusions may emerge. 

Young children were killed in the U.S. before King’s assassination, but the problem seems to have gotten worse. Massacres, usually unmotivated by any recognizable ideology, sometimes occur on a weekly basis. It is unjustifiable that this situation could continue in an educated and developed society.

I believe that we don’t yet know whether gun freedom or gun prohibition represents the ideal policy choice to abolish the atrocities that have become a recurrent feature of modern life in the U.S.  

We don’t yet know exactly how to solve this problem, because we have never solved it before. Some commentators may speculate that we can take a lesson from Britain or Australia, which are said to enjoy reduced violence because they have abolished firearms. But we have never before solved the current problem, because the U.S. has never before experienced the spate of recurrent massacres and atrocities that has characterized the decades following Columbine.

Because we have never faced this problem, we have never before solved it. Therefore, the U.S. will most likely have to experiment with more than one solution to the ongoing massacres, before the right remedy is hit upon.

The remedy we are trying out now is an individual right to handgun ownership; that’s the remedy that is currently thought was included in the federal constitution. As a policy matter, then, I say, let’s try the individual rights view, and see if it helps to address our problem with atrocities. If it doesn’t, we may have to try something else, and thereby eventually succeed by a process of trial and error.

Speaking of which, what if individual gun ownership doesn’t solve the problem of frequent massacres? That raises thorny questions indeed. For if prevalent atrocities persist notwithstanding gun freedom, then it seems reasonable to think that we as a society should at least consider gun prohibition, and see if that eliminates massacres.

But how? Even if the Constitution were amended, we would have a hard time figuring out how to implement gun prohibition as a policy measure, even if we had to and wanted to. Therefore, while we give gun freedom its fair chance to eliminate atrocities, I propose that we should roll out a pilot project of gun prohibition somewhere, to see if we can learn something about how we would implement it, perhaps in some locality that has historically disfavored the personal rights view, perhaps such as a Quaker community in Pennsylvania.

                              What is Meta-Pacifism?

I say that Dr. King should be revered much more than he is, because he was an idealist and an activist, and far too many people are neither. King was not exactly a revolutionary, perhaps, but he was a pacifist, and in that sense he envisioned changes far more profound than any transition of state power or constitutional policy. 

Having just concluded a section about firearms, then, in what sense do I praise pacifism? When I think of pacifism, I might not mean what most people think of, so I will use the word ‘meta-pacifism.’

One basis for meta-pacifism proceeds from the assumption that human beings may ultimately learn to live without violence; at least, that we can’t rule out the possibility. (The assumption could also be described as an appropriate suspension of belief in the inevitability and universality of human violence, based on a historical record).

Meta-pacifism, then, is a belief in the principle that human beings should try to abolish violence. (I myself don’t mean that human beings shouldn’t use violence to defend themselves, although with enough foresight, perhaps that day would never come).

  I reach this conclusion by observing that human beings have always succeeded in accomplishing those things that we’ve always yearned for, such as the ability to fly. Human beings have always expressed the dream of living without violence. Some day, therefore, we may learn to do so.

Furthermore, I assume that that accomplishment would be a good thing- and that’s a big assumption. I can imagine several circumstances under which, arguably, a nonviolent human future might not be a good thing. What if, for example, human beings live nonviolently in a permanent, docile state of servitude? 

Another conceivable way that a nonviolent humankind might not be a good prospect is that human beings, although nonviolent toward one another, conceivably could nonetheless exploit other living things more ruthlessly, efficiently, and destructively.

But I assume that a humankind which has been made more secure by means of reduced human violence would be more rational (also a big assumption; after all, it is sometimes said that ‘necessity is the mother of invention’). Furthermore, I assume 

that a more rational humankind would be more benevolent. 

Prof. Steven Pinker, PhD, arrives at similar conclusions via a different logical path in his great book, ‘The Better Angels of Our Nature.’(11). Pinker makes varied and elaborate efforts to prove his hypothesis, which is that human violence is declining. 

Reflection reveals how startling this hypothesis is, ands how profound its implications. Could it really be that humankind was less violent in the 20th century than in the prehistoric times? The fact that he makes a diligent effort to lay the groundwork for a scientific proof of this ultimate question makes his work all the more remarkable. 

I’m an unabashed fan of Pinker’s book (although I don’t necessarily like what he says about ‘The Who’ or what he calls the anti-civilization movements of the 1960s).

I should add that I’m not entirely certain Pinker’s efforts to prove his hypothesis by historical data are altogether successful. At one point he points to an excavation of prehistoric human remains, and attempts to reach a historical conclusion as to the level of violence prevalent in prehistoric societies by analyzing markings on their bones; but this method is cast in doubt by the relatively small sample size in comparison to the scope of the question. (He does much better, on the other hand, when he is analyzing data from counties in England which systematically tracked homicides for several centuries).

I have a hard time fathoming what kind of scientific proof would suffice to answer the question Pinker poses. The difficulties in proving Dr. Pinker’s hypothesis may be inevitable, because one end of the equation is lost in the sands of time, while the other end may be on a cosmic scale.

Nonetheless, Prof. Pinker certainly poses one of the most important questions of our time: have all of our human efforts been to any benefit, or has the human project been in vain, or even counter-productive? For merely posing the question and for laying out some groundwork for an attempted historical proof of its answer, I applaud Pinker’s work.

In commemoration of King, we should learn about the meta-pacifist position, and we should consider adopting it.

                                Conclusion

       Martin Luther King made essential contributions to the human project in the 20th century. He should be honored more than he is.

Judges and scholars who want to honor King can make arguments in their opinions as to why the collateral bar rule should be abolished in First Amendment cases. Thoughtful people can be meta-pacifists (which doesn’t require engaging in a complex and dubious debate about self-defense). The civic-minded can recognize that our society contains contradictions rooted in the founders’ intention to create a society without the very large standing army that we have today, and they can discourage their friends and relatives from participating in it. Americans can be internationalists, and thereby participate in a human project which transcends national boundaries.

A pacifist, Rev. King was among the most radical of humanists. To authentically commemorate him, we should do something radical every day.

References:

¹ Grose, Carolyn, Put Your Body on the Line: Civil Disobedience and Injunctions (1994). Brooklyn Law Review , Vol. 59, 1994. Available at SSRN: https://ssrn.com/abstract=1679903

² Walker v Birmingham, 388 US 307 (1967)

³ See, for example, Saia v New York, 334 U.S. 558 (1948); Kunz v New York, 340 U.S. 290 (1951); Niemotko v State of Maryland, 71 S. Ct. 325 (1951)

⁴ Cantwell v Connecticut, 310 US 296, 306 (1939)

⁵ Lovell v Griffin, 82 L.Ed. 949 (1938)

⁶ Shuttlesworth v. Birmingham, 394 US 147 (1969). 

⁷ See Walker at 319, n. 13.

⁸ See, for example, ‘Critical Legal Readings of Walker v. Birmingham’ (Harvard University website), https://cyber.harvard.edu/bridge/CriticalTheory/walker.txt.htm. (accessed February 18, 2017): the Shuttlesworth case pertaining to the Good Friday march “was framed by members of the same civil rights group who had refrained from marching and thus were not barred from raising substantive challenges.” 

⁹ “The ‘Collateral Bar’ Rule and the First Amendment: The Constitutionality of Enforcing Unconstitutional Orders,’ R. Labunski, 37 Am. U. Law Rev. 323 (1988).

¹⁰ According to many scholars, there are at least four interests protected by the Second Amendment: the right to revolution; the right to defend oneself against the government; the right to defend oneself against one’s neighbors (in other words, other persons in the U.S.); and the right to defend oneself against other persons not in the U.S. (See, for example, “Civic Republicanism and the Citizen Militia: the Terrifying Second Amendment,” D. Williams, 101 Yale L.J. 551 (1991), which discusses without adopting this position). In discussing arms issues, this essay simplifies the analysis by considering only the third value, the right to defend oneself against other persons in the U.S. This essay omits consideration of the other Second Amendment values, as well as certain “truther” issues. These issues may indeed complicate the analysis as far as the discussion of arms is concerned; but my ultimate conclusions as to preventing  massacres should remain the same were these other analyses included.

¹¹ Pinker, S. (2011). The Better Angels of Our Nature. New York, NY: Viking.

Three Cheers for New York City’s New Freelance Contract Law

by John Otrompke

It may have been buried in the tumult following this fall’s election, but New York City passed landmark social reform legislation in November, which may help to assure that the city continues to be a remarkably decent place to be creative and independent.

The Freelance Isn’t Free Act (FIFA), which became law on Nov. 16, makes significant changes to traditional contract law, and with but one exception, it probably doesn’t raise any major issues under the U.S. Constitution.

While FIFA falls short of the more thorough redistribution of economic power I favor, FIFA should nonetheless be helpful to independent contractors, and is worthy of celebration.

FIFA’s Economic Rationale

FIFA is designed to protect independent contractors; indeed, the law was motivated, in part, by the growth of self-employed workers as a economic sector.

According to some researchers, for example, more than 14.8 million people (constituting more than 10% of workers in the U.S.) were self-employed in 2014. The sector was growing at a rate of 5.4% per year. (1)

Indeed, FIFA is one of a number of laws addressing contract law and independent contractors which governments in New York state have mulled in recent years. Other examples have included the Construction Industry Fair Play Act (2014), the New York State Commercial Goods Transportation Industry Fair Play Act, and Assembly Bill 2539 (2016), which concerns modeling agencies.

Many factors combine to render freelancers vulnerable to unfair contract negotiations. However, contract law applies to almost everyone in our society, and is elegantly simple in design. Therefore, it is useful to learn a little bit of it. 

Basically, in our society, having an enforceable contract just requires an offer, acceptance, and consideration.

In layperson’s terms, that just means that both sides agree that there should be a deal, and each side agrees to do something, or give something, of value in exchange for it. In some cases, these critical requirements can even be established through a series of emails.

Nor does a contract even necessarily have to be in writing, though there are a few exceptions, which were created by a law passed in England in 1677, called ‘the Statute of Frauds.’ Exceptions, or types of contracts that have to be in writing to be enforceable, include contracts for marriage, or for the sale of land, or for the sale of goods worth more than $300, or for work which cannot be performed in less than a year, among a couple of others.

How Does FIFA Change Contract Law?

FIFA changes that rule, but it does so in a way that requires the client to assume a little bit of the freelancer’s burden. FIFA requires contracts for work worth more than $800 to be in writing; but it doesn’t appear to render such a contract which is not in writing unenforceable; instead, it penalizes the client by allowing the freelancer to sue them for $200 per violation. 

Perhaps FIFA may even apply to a contract that specifies a “kill fee,” or that claims to give the client a right to “cancel” the agreement at will; because such agreements lack what is known as “mutuality of obligation,” such a document could be considered a ‘non-contract,’ and so open up the client to FIFA liability. 

  And FIFA also contains a prohibition against retaliation, which means that if an independent contractor sues a client for doing business without a written contract, perhaps they could assert a right to future business if they’ve done a good job.

But probably the biggest change to contract law made by FIFA is that it creates a cause of action for double damages for breach. One of the things that makes it hard to be a freelancer in much of the country is that conventional contract law may sometimes only allow an individual to recover the amount they were promised. Hopefully, another FIFA provision, which can make the client pay a freelancer’s attorney fees, will also make it easier to go to court, and thus, make it easier for independent contractors to stay in business.

All in all, FIFA enacts a wide variety of remedies, some of which are available to individuals, while others are available to the City Department of Consumer Affairs, which may pursue civil penalties of up to $25,000.

Of course, there are limitations in the law: it doesn’t apply to doctors, lawyers, or salespersons, for example, and its effective date was delayed for six months.  

FIFA is Immensely Beneficial and Probably Constitutional

As mentioned earlier, while FIFA makes some dramatic changes to traditional American contract law, for the most part, the changes are unlikely to have constitutional implications (with one exception, which is soon to be discussed).

Why is that? After all, you might think, Article I, section 10, clause 1, of the American Constitution contains an explicit clause referring to contracts. 

For a brief period shortly the Civil War, this clause (known as the “Bills of Attainder clause”) was even referred to as “our Bill of Rights in miniature against the states[.]” (2).

The clause reads “No State shall...pass any Bill of Attainder, ex post facto Law, or Law impairing the Obligation of Contracts[.]” 

But much of its import was read out of the Constitution in the Depression era, following a famous political maneuver named by newspapers (and forever after referred to by law professors as) “the switch in time that saved the nine.”

(As an interesting side note, while FDR’s court-packing scheme of the Great Depression era is famous among American legal scholars, it was far from the only time a government has resorted to such measures. Historians, for example, may remember the threat to pack the House of Lords made in 1832 by the British Crown, which had the power of making new peers, and thereby resolved the crisis over the Reform Act, which had been stalled by the bicameral nature of Parliament). (3)

Prior to the Depression and Roosevelt’s court-packing scheme, the Supreme Court had often held that the constitution makes it difficult for the federal government to intervene in contractual matters, good motives notwithstanding. 

At the time, the drive to radically redistribute America’s financial power and resources was suppressed, at least temporarily. And when the Depression struck, it became apparent that there was a real place in society for social welfare measures. The jurisprudential situation came to a head in West Coast Hotel Co. v. Parrish, 300 US 379 (1937), in which the Supreme Court upheld early minimum wage laws.

Thereafter, many social welfare laws in the 20th century changed contract law.

It is also important to note that some state constitutions still pay respect to the traditional view that the right to earn a living is a fundamental constitutional right. While 

such “right to work” laws are sometimes characterized as union-busting schemes, there are some good things about the concept, too. (In particular, such a principle might make it easier to get government-issued professional licenses, take some of the mystery out of the process, and take away a certain amount of governmental discretion in licensure matters).

Conclusion

So if most of FIFA is likely to pass constitutional muster under contemporary views of the Obligation of Contracts clause and the 14th Amendment selective incorporation process, then what is the exception? 

There is one other interesting provision of FIFA that I have not yet mentioned, which in some cases makes it a criminal misdemeanor for a client to fail to pay a freelancer. 

If this provision is ever enforced, are we headed back to the era of debtor’s prison? While some say that era never really disappeared, the Supreme Court has put 

certain limitations on imprisonment for debt. In Bearden v Georgia, 461 US 660 (1983), 

the Supreme Court held that a debtor’s imprisonment violates the Fourteenth Amendment in the absence of evidence that the person being prosecuted willfully chose not to pay the debt.

FIFA makes significant changes in the traditional law of contract, which are likely to redound to the benefit of independent contractors. With the possible exception of the law’s criminal provision, FIFA will probably will not raise any constitutional issues.

The main question which remains is whether other jurisdictions will follow suit.

John J. Otrompke, JD, is a legal commentator, and was a 2015 faculty applicant at the Association of American Law Schools faculty recruitment conference. He has never practiced law. He has worked as a freelance journalist, and has been associated with Chicago Working Journalists (which is an effort involving the unionization of freelance writers). 

¹ Maher M, “Freelance Isn’t Free: The Rise of the Abandoned Workforce,” p. 14 Thesis paper, CUNY Baruch College, Spring 2016 (on file with the author).

2 See, for example, Cummings v Missouri, 71 U.S. 277 (1867); Ex Parte Garland, 71 U.S. 333 (1866).

3 Bagehot, W, “The English Constitution,” p. 79 (Oxford University Press, 2009). 

The Common Rule, Child Suicides and the Psychological Autopsy

Hi everyone, Happy New Year.

I have finished a draft of a law review article discussing whether the proposed changes to the federal Common Rule governing human subjects protection would permit a universal program of psychological "autopsies" of children who have committed suicide.

This is a work in progress, but here is my thesis:

"This paper proposes two universal prospective studies, utilizing a technique called the psychological autopsy, one of all child suicides, and another of all school massacre assailants, in the U.S. This article argues that provisions contained in the 2015 proposal to revise the federal Common Rule governing human subjects protection would make these studies more feasible, especially provisions concerning public health surveillance and certain interview procedures, as well as a provision for centralized IRB review. However, such research is associated with more than usual hazard, and should be conducted with great care."

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.