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The FDA's Role in Innovative Change

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Paul Overbee, Articles Editor

In Volume Six, Issue Two of the Minnesota Journal of Law, Science and Technology, Susan B. Foote and Robert Berlin penned a piece titled "Can Regulation be as Innovative as Science and Technology? The FDA's Regulation of Combination Products." Published in 2005, this piece set out to explore whether an agency as slow as the FDA could keep pace with ongoing technological innovations and respond in an appropriate and timely manner. Ultimately the authors concluded that the FDA is an agency that progresses in an iterative and incremental manner, and that both politics and administrative law were likely to prevent the FDA from being a force for innovation. The authors tried to justify the potential block to innovation by arguing that innovators and manufacturers benefit from the predictability and certainty and that a slow regulatory is the essential cost of these benefits. As such, the authors offered that regulation would come after innovations occurred rather than predicting upcoming innovation and issuing preliminary regulation.

Since the time of the author's predictions, they have been proven correct in many ways. For instance, nanotechnology is an emerging technology with many predicting how it will be implemented in the future, and it has already has appeared in products such as sunscreens and spray paints. Despite its current presence in society, the FDA has failed to issue a formal definition of what nanotechnology is and what it is not. As such the predictability and certainty that is desired by innovators is lacking. One of the most recent developments that continue to show that the FDA is ill-equipped to deal with fast paced innovation is their recent draft guidance on combination products. A full 10 years after Foote and Berlin criticized the FDA's ability to act swiftly, the FDA has finally issued a draft guidance to clarify and explain the current good manufacturing practices for combination products. This guidance has been made available by the FDA

The FDA defines a combination product as any combination of a drug, device, or biological products, taken individually as constituent parts of the combination product. Additionally, a combination may be two or more separate products that have been packaged together in a single package such as pre-filled syringes. The new FDA guidance gives multiple options for combination products to meet current good manufacturing practices. First, the producer may demonstrate compliance under the current drug manufacturing practices or by meeting qualify system regulations; this option is available where the combination is both a drug and device. The other option is that the manufacturer may demonstrate compliance will all good manufacturing practices that are applicable to each constituent part that makes up the whole combination product.

Both Berlin and Foote justified the slow moving nature of the FDA by stating that it may provide the type of predictability and certainty that is desired by innovators. Since that date, actions by the FDA have put that predictability and certainty in question. Instead of having a clear practice in place, the FDA may leave manufacturers guessing for years before the agency comments on their appropriateness. Berlin and Foote both agreed that perhaps the FDA wasn't properly tooled to deal with ongoing innovation, but ongoing developments continue to drive that point home.

The Development of Autonomous Vehicles

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Kirsten Johanson, MJLST Staff Member

On a glorious Halloween day last fall, the Minnesota Journal of Law, Science and Technology (MJLST) co-sponsored its annual symposium entitled "Automated Vehicles: The Legal and Policy Road Ahead." As the title implies, this symposium focused on one of the more exciting and innovative areas of the automotive industry--self-driving cars. Numerous academics, researchers, and innovators in the industry presented on the major issues that impact this industry's future, specifically in terms of safety and other regulatory standards. Ensuring that proper standards are in place before these vehicles take to the roads is necessary to protect the pubic against everything from the cars' operations in bad weather conditions to irresponsible human operators. Many of these standards require legislative involvement to craft state and national policy that strikes the delicate balance between safety and integration of new technology.

These issues are hugely important in the future development and integration of autonomous vehicle technology. In recognition of that importance, MJLST's upcoming publication (Volume 16.2) is expected to include four articles written by experts and scholars in the autonomous vehicle field that address a number of major issues that arise in conjunction with the development of autonomous vehicle technology. Each of these articles expands on a particular idea presented at the symposium but, despite the differences in article topics, one recurring theme is the radical change that will develop upon a workable regulatory scheme and publicly available vehicles.

While numerous regulatory concerns require further development before these so-called self-driving cars are ready to hit the road with the general pubic at the wheel (or, in Google's case, lack thereof . . .), none of the major car companies are missing the opportunity to participate in the development of autonomous technology. Every major car manufacturer in the world from Volkswagen to Audi as well as the ever technologically savvy Google is trying its hand at autonomous development (see depictions below). Not only does this competitive push for technological creativity result in a dynamic array of vehicle characteristics and (most importantly) awesome looking cars, it also indicates that, given the proper regulatory structure, the autonomous vehicle industry is poised to explode.

That being said, this is an area of the law that must continue to adapt with the changing technology. Regulators need to understand the impacts autonomous cars will have on the public from both convenience and safety perspectives and draft legislation accordingly. The symposium articles published in MJLST Volume 16.2 recognize this regulatory need and address specific issues that provide helpful insight to any interested party.

Self-driving cars might be one of the more futuristic ideas of the next generation and all of the decisions of today will impact the ultimate success of such vehicles. A basic Internet search for "autonomous vehicles" shows the potential is there and growing every day--even companies like Uber are getting involved! The wave of the future is sneaking upon on us and what that wave looks like is up to the initial responsive decisions made in the next five years. Check out MJLST Volume 16.2 for an in-depth analysis of what those decisions might look like and how they will impact various aspects of your life.

In the meantime, take a look at the following examples of autonomous vehicles, Volkswagen Autonomous Car; Autonomous Audi; Google's Self-Driving Vehicle Prototype

I'm sure I am not alone in remembering the constant urgings to be careful what I post online. I was told not to send anything in an email I wouldn't want made public, and I guess it made some sense that the internet was commonly viewed as a sort of public forum. It was the place teens went to be relieve their angst, to post pictures, and to exchange messages. But the demographic of people that use the internet is constantly growing. My mom and sister communicate their garden interests using Pinterest (despite the fact that my mom needs help to download her new podcasts), and as yesterday's teens become today's adults, what people are comfortable putting online continues to expand. For example, the advent of online finances illustrate that the online world is about so much more than frivolity. The truth of the matter is that the internet shapes the way we think about ourselves. And as Lisa Durham Taylor observed in her article for MJLST in the spring of 2014, the courts are taking notice.

The article concerns the role of internet privacy in the employment context, noting that where once a company could monitor its employee's computer activity with impunity (after all, it was being done on the company time and with company resources), courts have recently realized that the internet stands for more than dalliance. In it, Taylor notes that the connectedness of employees brings with it both advantages and disadvantages to the corporation. It both helps and hinders productivity, offering a more efficient way of accomplishing a task, but providing the material for procrastination in an accompanying hand. When the line blurs, and people start using company time for personal acts, the line-drawing can get tricky. Companies have an important interest in preserving the confidentiality of their work, but courts have recently been drawing the lines to favor the employee over the employer. This is in stark contrast to the early decisions, which gave companies a broad right to discharge an "at-will" employee and found that there was no expectation of privacy in the workplace. Luckily, courts are beginning to recognize that the nature of a person's online interactions make the company's snooping more analogous to going through an employee's personal possessions than it is to monitoring an employee's efficiency.

I would add into the picture the recently-decided Supreme Court case of Riley v. California, where the Court held that a police needed a warrant to search a suspect's phone. The Court said that there was not reasonable cause to search a cell phone because the nature of the technology means that the police would be violating more than necessary to conduct normal business. They likened it to previous restrictions which prevented police from searching locked possessions incident to arrest, and sarcastically observed that cell phones have become "such a pervasive and insistent part of daily life that the proverbial visitor from Mars might conclude they were an important feature of human anatomy." The "vast quantities of personal information" and the fact that the phone itself is not a weapon make its taking unjustified in the course of a normal search.

This respect for the data of individuals seems to be signaling a new and incredibly complicated age of law. When does a person have the right to protect their data? When can that protection be broken? As discussed in a recent post on this blog, there is an ongoing debate about what to do with the data of decedents. To me, a conservative approach makes the most sense, especially in context with the cases discussed by Lisa Taylor and the decision in Riley v. California. However, courts have sided with those seeking access because the nature of a will grants the property of the deceased to the heirs, which has been extended to online "property." What Rebecca Cummings points out to help swing the balance back in favor of privacy, is that it is not just the property of the deceased to which you are granting access. The nature of email means that a person's inbox has copies of letters from others which may have never been intended for the eyes of someone else.

I can only imagine the number of people who, had they the presence of mind to consider this eventuality, would act differently either in the writing of their will or their management of their communications. I am sure that this is already something lawyers advise their clients about when discussing their plans for their estate, but for many, death comes before they have the chance to fully consider these things. As generations who have grown up on the internet start to encounter the issue in earnest, I have no doubt that the message will spread, but I can't help but feel it should be spreading already. So: what would your heirs find tucked away in the back of your online closet? And if the answer to that is something you'd rather not think about, perhaps we should support the shift to privacy in more aspects of the digital world.

Ian Blodger, MJLST Staff Member

Tesla Motors recently announced a software update to its Model S that will allow the vehicle to drive autonomously on highways. This development may be the first step toward an almost entirely autonomous vehicle fleet. This change to transportation could have profound implications on everything from city density to traffic safety.

Autonomous vehicles may eventually increase urban density by reducing the requirement for parking spaces in cities. Tesla's update will give its vehicles the ability to drive completely autonomously from a parking spot to pick up the vehicle owner. While Tesla states that this feature should currently be used only on private property, the programming opens up the possibility of radical changes to the current cityscape. Under the current transportation model, people who commute to work in larger cities must also find a place to park their car during the day. Additionally, this location must be relatively close to the person's place of work. With autonomous vehicles, however, commuters could be dropped off by their vehicle, which would then find parking outside the city. At the end of the day, the commuter would call their car to pick them up and drive home. This would allow developers to maximize the function of valuable real estate inside cities, currently being used only to park cars. Additionally, parking outside the city center could reduce costs for vehicle owners, since parking structures would have less financial overhead to account for in pricing. Essentially, the currently available technology will eventually allow for increased efficiency of valuable city real estate.

Moreover, autonomous vehicles could provide improved efficiency for commuters on their way to work. Since commuters will not need to concentrate on driving, they could pay attention to other tasks, like preparing for the workday. While Tesla's updates may not quite allow the vehicle owner to divert their full attention from the road, it gets close. As the quality of autonomous vehicle programming improves and the number of autonomous vehicles increases, commuters will be able to invest their full attention in things other than driving.

Besides these general efficiency improvements, autonomous vehicles may have the added benefit of decreasing motorist deaths. According to the Association for Safe International Road Travel, the United States has more than more than 37,000 traffic deaths each year. Since many of these deaths are caused by driver error, allowing vehicles to take the wheel could save thousands of lives each year. Tesla's updates are just the first step to improving the safety and efficiency of our roadways.

The Minnesota Journal of Law Science and Technology recently held a symposium on the legal and social implications of autonomous vehicle technology, and will be publishing a number of articles adapted from speaker's presentations in the upcoming Spring 2015 issue of Volume 16. The articles vary widely in their analyses of the social and legal implications of autonomous vehicles, and will be a great resource for anyone interested in learning more about the subject.

A Story to Warm Your Iron-Rich Hemoglobin

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Becky Huting, MJLST Articles Editor

While recently home in Chicago on spring break, I offered to make my dad a spinach-packed smoothie. My dad (a good sport) agreed, but asked me to make it light on the spinach as he understood men at his age (60) should be taking it easy on the iron intake. I had heard this principle before, and knew that men's and women's vitamin supplements were different in part due to the additional iron needs of women. My dad was right about one thing: he needs a lot less iron than me. His recommended dietary allowance for iron is 8 mg/day whereas mine is a lofty 18 mg/day. In actuality, men rarely suffer from iron deficiency so supplements are usually unnecessary, and in fact too much iron can indeed be harmful. There are possible links with excessive iron consumption to diabetes as well as neurodegenerative disease.

But where his concerns are unfounded are in the nutritional numbers. One cup of uncooked spinach contains only .8 mg of iron. That is only one-tenth of his daily iron needs. Three ounces of ground beef containing 15% fat contains 2.2 mg of iron. What about his daily serving of canned, drained clams, you ask? Fine, you have me there: if my father actually consumed such item, he'd have gone over at 23.8 mg of iron. It is very hard though for a human to overdose on iron from food, because an adult body has systems in place to regulate the amount of iron it absorbs. In short, my dad need not be concerned about spinach in his smoothie, except for reasons of palatability.

So given the different nutritional needs of men, women, and also children, what entity is telling consumers whether a vitamin is for them by way of labels? The Food and Drug Administration (FDA) relinquished that duty back in October of 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. This law created a new regulatory framework for the safety and labeling of dietary supplement that places the responsibility on the product manufacturers rather than the FDA. The DSHEA was a response to lobbying by health food companies to vote down several bills that would have had the effect of increasing the FDA's powers over supplement labeling. Celebrities even got involved. In one commercial, Mel Gibson portrayed a citizen being raided and arrested by FDA agents for possessing a bottle of Vitamin C.

This mentality that too much government oversight is a bad thing is a popular ideal. After all, it's only a vitamin. Perhaps a label signifying use by pregnant and nursing moms is enough, but consider the 60-year-old guy grabbing this supplement in haste. He is now getting 27 mg iron per day from the vitamin alone, perfect for a pregnant woman, but over 3X his nutritional needs. Are a few words on a label enough to signify safety to a consumer? Certainly there is an argument that too much information will lead to a cluttered, confused label. So where do you come down, bring the FDA back in or leave it to the companies? And do you feel like a green smoothie? I promise you the banana masks the spinach flavor.

Ke Huang, MJLST Lead Articles Editor

The Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act) generally provides that, by 2015, healthcare providers must comply with the Act's electronic health record (EHR) benchmarks, or, the government would reduce these providers' Medicare payments by one percent.

These provisions of the HITECH Act are more than a health policy footnote. Especially for attorneys, the growing use of EHRs raises several legal issues. Indeed, in Volume 10, Issue 1 of the Minnesota Journal of Law, Science & Technology, published six years ago, Kari Bomash analyzes the consequence of EHRs in three legal-related aspects. In Privacy and Public Health in the Information Age, Bomash discusses how a Minnesota Health Records Act amendment relates to: (1) privacy, especially consent of patients, (2) data security (Bomash was almost prescient given the growing security concerns), and (3) data use regulations that affect medical doctors.

Bomash's discussion is not exhaustive. EHRs also raise legal issues running the gamut of intellectual property, e-discovery, to malpractice. Given that software runs EHRs, IP industry is very much implicated. So much so that some proponents of EHR even support open source. (Another MJLST Article explains the concept of open source.)

E-discovery may be more straightforward. Like other legal parties maintaining electronic stored information, health entities storing EHR must comply with court laws governing discovery.

And malpractice? One doctor suggested in a recent Wall Street Journal op-ed that EHR interferes with a doctor's quality of care. Since quality of care, or lack thereof, is correlated with malpractice actions, commentators raised the concern that EHR could raise malpractice actions. A 2010 New England Journal of Medicine study addressed this topic but could not provide a conclusive answer.

Even my personal experience with EHRs is one of the reasons that lead me to want to become an attorney. As a child growing up in an immigrant community, I often accompanied adult immigrants, to interpret in contract closings, small-business transactions, and even clinic visits. Helping in those matters sparked my interest in law. In one of the clinic visits, I noticed that an EHR print-out of my female cousin stated that she was male. I explained the error to her.

"I suppose you have to ask them to change it, then," she said.

I did. I learned from talking to the clinic administrator the EHR software was programmed to recognize female names, and, for names that were ambiguous, as was my cousin's, the software automatically categorized the patient as male. Even if my cousin's visit was for an ob-gyn check-up.

Will Orlady, MJLST Staff Member

In Privatizing Biomedical Citizenship: Risk, Duty, and Potential in the Circle of Pharmaceutical Life, Professor Jonathan Khan wrote: "genomic research is at an impasse." Though genomic research has advanced incrementally since the completion of the first draft of the human genome, Khan asserts, "few of the grandest promises of genomics have materialized." This apparent lack of progress is a complex issue. Further, one may be left asking whether, within the current economic and regulatory scheme, genomics actually has promising answers to give. But Khan's work cites to biomedical researchers, claiming that what is needed to propel genomic research forward is simple: more bodies.

Indeed, it is a simple answer, but to which question--or questions? Khan's article explores the "interconnections among five . . . federally sponsored biomedical initiatives of the past decade in order to illuminate critical aspects of the current drive to get bodies." To be sure, the article provides the literature with a fine starting analysis of public biomedical programs, synthesizing much of the previous research on biomedical research participation. It further evaluates previously proposed methods for increasing genomic research participation. Khan's article, however, left me with more questions than answers. If the public and private sectors cannot work together to produce results, then who is left to ensure progress? Is progress currently feasible? Are we being too hasty and impatient demanding results from an admittedly young scientific discipline? And, ultimately, if study participants/subjects are expected to participate with their own genetic material or bodies, what do they get in return?

Khan's article attempts to address the final question. That is, if we are to create a legal or social obligation to contribute to genomic research for the sake of the public, what benefit (or, at the least, what safety assurance) do contributors receive in return for their contribution? Clearly, issues associated with creating a system of duties while providing no corresponding rights are aplenty. Underlying this discussion is the notion that to ensure the timely progress of genomic research mandated participation in such research might be necessary. Herein lies a problem: "[t]hese duties effectively privatize citizenship, recasting service to the political community as a function of service to [an] . . . enterprise of biomedical research. . . . " What is more, Khan is keen to point out that time and time again, promises of genomic advancement in the hands of collaborating private and public entities have failed to produce promised results.

If we are to go forward privatizing citizenship, creating duties for persons to use their bodies for the benefit of society, we must be careful to ensure that (1) individual rights in the outcome of the research are secured; and, (2) that society will in fact benefit from the collectively imposed obligations.

Although Khan's article leaves many questions unanswered, I empathize with his weariness of creating a public duty to contribute to biomedical research. Solutions to such complex issues are not easily answered. Torpid genomic research is troubling. But, so is the notion of privatized citizenship ascribing duties without granting corresponding rights. Though more bodies may be needed to further the timely advance genomic research, policymakers academics alike should be cautious creating any programs which compromise the integrity of personal privacy for the sake of public advancement without granting corresponding rights.

Thomas Hale-Kupiec, MJLST Staff Member

President Barack Obama proposed spending $215 million on a 'precision medicine' initiative. The largest part of the money, $130 million, would go to the National Institutes of Health in order to create a population-scale study. This study would create a database containing health information with genetic, environmental, lifestyle, medical and microbial data from both healthy and sick volunteers with the aim that it will be used to accelerate medical research and to personalize treatments to patients. Though some would call this a "bio-bank," Francis Collins, director of the National Institutes of Health, said that instead, the project is greater than that, as it is combining data from among what he called more than 200 large American health studies that are ongoing and together involve at least two million people. "Fortunately, we don't have to start from scratch," he said. "The challenge of this initiative is to link those together. It's more a distributed approach than centralized." Further, the President immediately attempted to alleviate concerns related to privacy: "We're going to make sure that protecting patient privacy is built into our efforts from Day 1. . . I'm proud we have so many patients-rights advocates with us here today. They're not going to be on the sidelines. This is not going to be an afterthought. They'll help us design this initiative from the ground up, making sure that we harness the new technologies and opportunities in a responsible way."

Three major issues seem to be implicated in this proposed database study. First, both informed consent and incidental findings seem to be problematic in this model. When ascertaining information from the American health studies, the government may be bypassing what users initially consented to when agreeing to participate in the study. Further, incidental findings and individual research results of potential health, reproductive, or personal importance to individual contributors are implicated in these studies; these aspects need to be considered in order to avoid any liability going forward, and provide participates with expectations of how their information may be used. Second, collection and retention of this information seem to be an issue. Questions on when, where, and how long this information is being held creates a vast array of privacy concerns. Further, security of this information may be implicated, as some of this data may be personal. Third, deletion or removal of this information may be an issue if the program ever becomes discontinued, or if users are allowed to opt-out. Options after closure include destroying the specimens, transferring them to another facility, or letting them sit unused in freezers. These raise a multitude of questions about what to do with specimens and when level of consent should be implicated.

Overall, this database seems to hold immeasurable potential for the future of medicine. This said, legal and ethical considerations must be considered during of this new policy's development and implementation; with this immeasurable power comes great responsibility.

Benjamin Borden, MJLST Staff Member

Last week the Federal Communications Commission (FCC) voted to approve net neutrality rules. In doing so, the FCC barred Internet Service Providers (ISPs) from blocking web traffic or letting them charge websites for priority service. Additionally, the FCC asserted authority to regulate broadband providers as public utilities. This decision was met with sharp criticism from some and applauded by others. This post, however, does not seek to dissect the benefits and drawbacks of these newly passed rules. Rather, it seeks to take a step back and use the net neutrality debate to put the overall conversation about internet use and freedom in the United States in perspective with other approaches around the world. Taking that view and comparing it to the relationship of the Chinese government with Internet use leaves striking results.

As Jyh-An Lee and Ching-Yi Liu assert in their article, Forbidden City Enclosed by the Great Firewall: The Law and Power of Internet Filtering in China, the Chinese government has built an advanced Internet filtering system meant to block any content viewed by the government as a threat to the Chinese state. Additionally, the Chinese government has used technological advances to control and ultimately advance its own ideology on the Internet. The authors argue under Lawrence Lessig's theory that the government's controlling of access to Internet content is much more effective in regulating people's online behavior compared with using the law to do so.

Based on the recent net neutrality approval, regulators in the United States will likely use both the power of open access and the power of the law to ensure that the Internet remains a place for all. The U.S. government is concerned with whether or not ISPs may charge certain websites a fee to give them priority speeds over other non-paying websites. The Chinese government, on the other hand, is seeking to make technological advances that will allow it to better censor Internet content for those living in China. This is not a suggestion that American principles relating to Internet freedom must be adopted by every nation around the globe, as the domestic politics of nations are protected by norms of sovereignty. The Internet, however, is a great equalizer of information and knowledge. And while certain nations might be arguing about the best means of delivering Internet content to its citizens, others are still attempting to severely limit what its population may see. This latter strategy will likely discourage innovation in the long run and will decrease people's trust in the Internet as a place of unfettered knowledge.

The recent ruling on net neutrality may not present the perfect answer to the question of how to regulate the Internet and broadband providers. The debate itself, however, makes clear that Internet access in the United States is focused on ensuring access for all people. Such a paradigm seems more likely to succeed in a technologically driven world compared with one that seeks to limit anti-government content. Innovation stems from a desire to do more. If the overarching policy goal is to stop content, then what incentive is there to advance?

Revisiting the Idea of a Patent Small Claims Court

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Comi Sharif, Managing Editor

In 2009, Robert P. Greenspoon explored the idea of adjusting the patent court system to improve efficiency for the adjudication of small-scale claims. His article, Is the United States Finally Ready for a Patent Small Claims Court?, appearing in Volume 10 Issue 2 of the Minnesota Journal of Law, Science & Technology, pointed out the deterrent-like effect that high transaction costs involved with traditional patent litigation have on inventors trying to protect their intellectual property. Greenspoon argues that if patent holders are merely trying to recover small sums from infringers, the lengthy and expensive patent litigation system currently in effect often outweighs the remedies available through litigation. As a result, Greenspoon suggests the creation of a "Patent Small Claims Court" to resolve these issues. Seeing that it's been over five years since Greenspoon's article, it makes sense to reexamine this topic and identify the some of the recent developments related to the article.

In May of 2012, the USPTO and United States Copyright Office co-sponsored a roundtable discussion to consider the possible introduction of small claims courts for patent and copyright claims. A few months later, The USPTO held another forum focused solely on patent small claims proceedings. A major emphasis of these discussions was conformity of the new court with the U.S. Constitution (an issue addressed by Greenspoon in his article). In December of 2012 the USPTO published a questionnaire to seek feedback from the public on the idea of a patent small claims court. The focus of the survey involved matters relating to subject matter jurisdiction, venue, case management, appellate review, and available remedies. See this link for the official request and list of questions from the USPTO submitted in the Federal Register. The deadline for submitting responses has since passed, but the results of the survey are still unclear.

In Greenspoon's article, he addresses a few of the unsuccessful past attempts to create a small claims patent court. In 2013, the House of Representative passed a bill, which authorized further study into the idea of developing a pilot program for patent small claims procedures in certain judicial districts. See H.R. 3309, 113th Cong. (2013). Senate did not pass the bill, however, so no further progress occurred.

Overall, though there appears to be continued interest in creating a patent small claims system, it doesn't seem likely that one will be created in the near future. The idea is far from dead, though, and perhaps some of Greenspoon's proposals can still help influence a change. Stay tuned.