Articles by mjlst

Supreme Court to the Rescue: The First Sale Doctrine Survives

April 9, 2013
Intellectual Property

by Benjamin Hamborg, UMN Law Student, MJLST Articles Editor

As predicted inJohn Wiley & Sons, Inc. v. Kirtsaeng: The Uncertain Future of the First-Sale Doctrine, the Supreme Court last month held, by a 6-3 margin, that the first sale doctrine does apply to works lawfully made outside of the United States. The first sale doctrine, which allows the lawful owner of a copyrighted work to dispose of that copy as he or she sees fit, was in danger of disappearing as applied to works manufactured overseas after the Second Circuit decided in August of 2011 that the doctrine only applied to works made in America.

Hailed by many as a victory for American consumers, See Gary Shapiro, Supreme Court Gives American Consumers Victory Over Copyright Owners in Kirtsaeng vs. John Wiley & Sons, FORBES (March 20, 2013, 9:16 AM), the decision also represents an important victory for American manufacturing. A decision to the contrary by the Supreme Court would have given companies in the United States, particularly publishing companies, an incentive to move manufacturing plants oversees in order to gain unlimited control over the resale of their products. In fact, any company would have been able to gain such control simply by affixing a copyrightable image or other work to an uncopyrightable product, such as a watch. Of course, as pointed out in Kirtsaeng v. John Wiley & Sons: No Good Deed Goes Unpunished, it remains to be seen whether this decision has a negative impact on the rest of the world, as publishers now have a disincentive to sell textbooks at a discounted rate in impoverished countries. See Roy Zwahlen, Kirtsaeng v. John Wiley & Sons: No Good Deed Goes Unpunished, PATENTLY BIOTECH (March 26, 2013).

United States v. Caronia After-The-Fact: What Was All That Fuss About, Again?

April 9, 2013
FDA, Pharmaceuticals

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

In a split decision on December 3, 2012, the Second Circuit issued its long-awaited opinion in U.S. v. Caronia–a case concerning off-label promotion and commercial free speech. The 2011 U.S. Supreme Court holding in Sorrell v. IMS Health acknowledging off-label promotion to be “per se” protected under the First Amendment marked a significant shift in this area of law. Previously, the Food and Drug Administration (FDA) was able to recover billions of dollars in penalties from manufacturers engaged in off-label promotion, or the act of promoting regulated products for uses other than those approved by the agency. Despite other challenges on constitutional grounds, the FDA has been successful at defending its current practice–that is, until recently.

After Sorrell, it was unclear how the Second Circuit would apply this precedent in Caronia. For a robust discussion of the holding in Sorrell and alternate regulatory pathways to mitigate the effects of constitutional challenges to FDA authority, see Rethinking Off-Label Regulation in the Wake of Sorrell v. IMS Health: Can State Involvement Compensate for Waning FDA Authority to Curb Commercial Free Speech? Much to the agency’s chagrin, the Second Circuit found that truthful, non-misleading off-label speech is in fact protected by the First Amendment and therefore cannot be prosecuted under the Federal Food, Drug and Cosmetics Act (FDCA). Although the circuit court opinion is not binding outside of its jurisdiction and is only one early example of how Sorrell will be interpreted by lower courts, the Caronia decision signals potentially diminishing regulatory authority in this realm.

To be sure, the gradual constitutional erosion of its authority to police purported FDCA violations is a viable cause for concern–but is it imminent? Though analysts predicted a more panicked response on behalf of the agency, the FDA has apparently decided not to petition the U.S. Supreme Court for certiorari, stating that the agency “does not believe. . . the Caronia decision will significantly affect [ its] enforcement” of off-label promotion. Because of its limited precedential value and the fact that both Sorrell and Caronia only recognize speech that is truthful and non-misleading as protected, the Second Circuit decision may have very little practical effect. In fact just last month in a related case out of the Ninth Circuit, U.S. v. Harkonen, the court chose to ignore Caronia altogether–asserting that the First Amendment does not protect “fraudulent speech.”

While off-label promotion itself cannot form the basis of an FDCA violation under Caronia, it may still be introduced as evidence of criminal misbranding. As such, it seems that the Caronia uproar could have all been for naught. The FDA’s reaction (or lack thereof) to the Second Circuit’s holding indicates that this is likely true. If nothing else, however, Caronia will surely increase the number of constitutional challenges to FDA enforcement activity, forcing the agency to reexamine its priorities. Thus, while Caronia has the potential for wide-ranging implications down the line, industry stakeholders will just have to wait and see. Although Caronia has done little to alter the regulatory landscape presently, it may only be a matter of time before a circuit split begins to evolve.

United States v. Caronia After-the-Fact: What Was All That Fuss About, Again?

April 9, 2013
FDA, Pharmaceuticals

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

Threats From North Korea: Switching Our Focus From Nuclear Weapons to Websites

April 8, 2013
Cyber Security, Internet, Law Enforecement

by Bryan Morben, UMN Law Student, MJLST Staff

There has been a lot of attention on North Korea and the possibility of a nuclear war lately. In fact, as recently as April 4, 2013, news broke that the increasingly hostile country moved medium-range missiles to its east coastline. It is reported that the missiles do not have enough range to hit the U.S. mainland, but is well within range of the South Korean capital. Tensions have been running high for several months, especially when the North took the liberty to shred the sixty year old armistice that ended the Korean War, and warned the world that “the next step was an act of ‘merciless’ military retaliation against its enemies.”

But perhaps the use of physical force by leader Kim Jong Un is not the only, or even the most important threat, from North Korea that the United States and its allies should be worried about. Despite the popular impression that North Korea is technologically inept, the regime boasts a significant cyber arsenal. The country has jammed GPS signals and also reportedly conducted cyber terrorism operations against media and financial institutions in the South. North Korea employs a host of sophisticated computer hackers capable of producing anonymous attacks against a variety of targets including military, governmental, educational, and commercial institutions. This ability to vitiate identity is one of the most powerful and dangerous parts about cyber warfare that isn’t possible in the physical world.

Susan Brenner is an expert in the field cyberwar, cybercrime, and cyber terrorism. She has been writing about how and why the institutions modern nation-states rely on to fend off the threats of war, crime, and terrorism have become ineffective as threats have migrated into cyberspace for over half a decade. Her article, Cyber-threats and the Limits of Bureaucratic Control, in Issue 14.1 of the Minnesota Journal of Law, Science & Technology outlines why we need a new threat-control strategy and how such a strategy could be structured and implemented. A strategy like the one Brenner recommends could help protect us from losing a cyberbattle with North Korea that most people aren’t even aware could happen.

Reviving GRAS(E): Bringing Reform to the Drug Approval Process

April 3, 2013
Food and Agriculture, Healthcare, Healthcare Reform, Pharmaceuticals, Public Health

by Maya Suresh, UMN Law Student, MJLST Staff

Bringing new drugs to the market has turned into a time consuming and costly process. Resulting in a process that takes roughly 12 years and 1.2 billion dollars to develop a single new drug and move it through the approval process, the current laws administered by the FDA have the potential to stifle potential economic growth. Current laws and FDA regulations require new drugs to go through three phases of clinical trials focusing on safety, optimal dosage, and effectiveness. It is in the prolonged third phase (where effectiveness is tested through extensive clinical trials) that many manufacturers decide to pull the drug from the program as the clinical trials threaten the firm’s financial viability. Ultimately, it is consumers that are hurt by the process, as they are unable to benefit from the drugs.

The negative effect on consumers is what Emily Puchalski hopes to eliminate with the recommendation detailed in her note published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology. In “Bringing Dormant GRAS(E) to Bloom: Reviving The GRASE Concept for Drugs,” Puchalski suggests that a revival of the Food and Drug Administration’s (FDA) “generally recognized as safe and effective” laws and regulations, commonly reffered to as “GRASE”, could minimize the negative effects on consumers. Many drugs, once discovered, have formulations found in earlier drugs that have already been established as safe for consumer use. The GRASE law is grounded in this understanding, and provides a way for these “already established as safe” drugs to get to the market quicker without having to go through extensive clinical trials.

The problem with GRASE however, is that it is very difficult for a drug to achieve GRASE status. Due to this difficulty, GRASE has fallen out of use as manufacturers have stopped trying to achieve the status. Puchalski suggests that if the FDA were to revive GRASE, it could convince manufacturers to apply for GRASE status, allowing already established safe and effective drugs to come to market more quickly, thus benefiting consumers.

It would appear that Puchalski’s recommendation is being heard. In late February Micropharma Limited was able to obtain GRASE status for their new heart health probiotic. Ryan Jones, CEO of Micropharma Limited, echoed Puchalski when he spoke of the benefits the company has been able to reap with the highly coveted status. GRASE status will allow the company to accelerate development of the drug within both the United States and international markets. Further, it provides strong reputational benefits for the company, as it makes clear to the public that Micropharma is committed to investing a significant amount of time and energy into providing safe and effective drugs to the market.

The ability for Micropharma to obtain GRASE status could serve as evidence of a potentially reformed drug approval process. However, the full benefits realized by consumers and the market will only become clear with time.

Subpeona of Data Provided by Research Participants Under Confidentiality Agreement Raises Concerns

April 2, 2013
Bioethics, Criminal Law

by Sabrina Ly

On February 25, 2013, an article was published in The Dartmouth describing the implementation of its Committee for the Protection of Human Subjects. The purpose of the committee is to answer ethical questions and review proposals regarding human subjects participating in research at Dartmouth College. The committee is comprised of experts and community members “who analyze the risk posed to participants by Dartmouth-affiliated researchers’ studies.” The timing of its creation could be coincidental, but may have been in response to legal action taken against Boston College subpoening confidential data provided by research participants in the “Belfast Project” in 2012.

Prior to interviews taking place as part of the Belfast Project, researchers promised interviewees that their identities and information contained in the transcripts would not be released until after their deaths. However, upon discovering the existence of the transcripts, British law enforcement worked with the U.S. Department of Justice to subpoena the transcripts to use in its criminal proceedings. This raised significant ethical issues pitting the needs of law enforcement against the need for participant confidentiality in certain research that benefits the public.

The problem of subpoenaing confidential human research information is further elaborated in an article recently published in Issue 14.1 of the Minnesota Journal of Law, Science and Technology. In Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice, Wolf, et al., discuss the importance of enforcing a certificate of confidentiality in human research studies. Confidentiality in order to obtain information from human subjects during research is vital to progression and understanding in health, science and many other fields. Often research requiring a promise of confidentiality involves difficult and controversial subjects that would be nearly impossible to study without an assurance of confidentiality.

A certificate of confidentiality encourages individuals to volunteer information they might not otherwise be willing to disclose by protecting their identity and privacy. By breaking the promise of confidentiality, the subpoenaing of the “Belfast Project” threatens academic freedom, and may deter future research participants from providing accurate personal information. Such reluctance to provide information could harm the work of researchers who might otherwise advance understanding and provide valuable insights on difficult issues. One example in which research is difficult without confidentiality is the willingness of individuals to share information about their sexuality, sexual behaviors, or drug-using behaviors. In past studies, researchers have been able to use this information to derive how HIV spread and implement methods to prevent the spread.

The broad benefits to society of upholding academic freedom, the right to privacy, and freedom of information, far outweigh any claim law-enforcement may have to subpoena confidential research data. While an individual prosecution may be important, the damage caused by allowing such a breach of confidentiality could greatly hinder society-benefiting research. The importance of enforcing certificates of confidentiality to prevent the criminalization of human research subjects is significant.

Boston College has filed a petition for a writ of certiorari in the Supreme Court to appeal the First Circuit’s ruling upholding the subpoenas.

Go Easy on the Doctors

April 2, 2013
Uncategorized

by Greg Singer, UMN Law Student, MJLST Managing Editor

The healthcare system in the United States is no stranger to debate. The current president won election, and recently re-election, due in no small part to his promises of reform in the area. It is no surprise that this is the case. People literally place their lives in the hands of the healthcare system, and utilize it so often that the combined spending on it consumes nearly 18% of the entire GDP (a figure that is only expected to rise as time wears on).

Yet anchoring the system that serves almost 315 million Americans is a surprisingly small contingent of no more than 960 thousand medical doctors (of whom only about 350 thousand are considered to be primary care physicians, and many of the remainder employed in non-patient-facing positions). This is an incredible burden placed on the shoulders of so few people, a burden that is only expected to become weightier in future years, as medical schools arguably fail to produce enough new physicians to properly care for the current set of patients, let alone all of the soon-to-be-patients as universal healthcare requirements set in pursuant to Affordable Health Care for America Act.

In Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications, published in volume 14.1 of the Minnesota Journal of Law, Science & Technology, authors John Grout, et al. argue that a significant portion of medical mistakes and errors may be attributable to a character flaw in the psyche of some physicians, specifically that they are beset with “a narcissism that blocks full acceptance of the notion that compliance rules apply to [them].” Moreover, the authors point to other character flaws, such as the performance of duties while under the influence and general substance abuse as significant causal factors for mistakes.

While these issues no doubt exist in one form or another, it is important to remember that the vast majority of doctors do try their best to help their patients. Given the unconscionable hours involved in the job, the relatively modest compensation for many, and the massive debt burdens required to enter the field, it is hard to imagine anyone, narcissistic or not, attempting it without possessing a truly real desire to help those in need. If anything, the simple exhaustion facing many doctors is a more understandable, and sympathetic, cause of error. Medical doctors are among the most overworked professionals in the United States, despite the extremely high stakes involved in their work. The high hours required is partly due to the culture surrounding the field, but the limited number of available physicians, despite the rising amount of time demanded by the growing lists of patients cannot be ignored.

Increasing enrollment in existing medical schools, or even creating new medical schools, may be a pathway to reducing medical mistakes errors, wait times, and perhaps even costs. But in the meantime, be understanding of your doctor. Do not immediately assume that his mistakes are due to arrogance or a flaw in his character. He may simply be tired.

Anti-Law School Scam Blogging Drastically Effecting Law School Application Rates

March 28, 2013
Uncategorized

by Savir Punia, UMN Law Student, MJLST Staff

The reports of Law School’s death are greatly exaggerated. At least I am hoping that is true. As a current law student I find myself frequenting blogs, websites and articles focused on the state of the law profession hoping I don’t become another “casualty” of law school. Since 2008, it has been a badly kept secret that the law profession is struggling and the internet is full of recent JD graduates sharing horror stories of their experiences in law school. Lucille A. Jewel‘s article, You’re Doing It Wrong: How the Anti-Law School Scam Blogging Movement Can Shape the Legal Profession, in Issue 12.1 of the Minnesota Journal of Law, Science & Technology, discusses just this, a community of malcontent JD graduates who have gathered together online to share personal stories and discourage others from going to law school.

While the argument of whether law school still remains a good investment is still debated, there is one result that has occurred due to the “Law School Scam Blogging” movement, applications are drastically down. According to the Law School Admission Council (LSAC), law school applications are headed for a 30-year low. LSAC expects there to be only 54,000 applications for the current enrollment cycle, which is down 20 percent from last year and a whopping 28 percent from 2010. Furthermore, the 54,000 law school application for this year is almost half of what it was in 2004 when there were 100,000 applications. This is in stark contrast to any other graduate or professional training school (except veterinary school). According to Debra W. Stewart, president of the Council of Graduate Schools, first-time enrollment to masters of business degree programs were steady – a 0.8 percent increase among Americans in 2011. Moreover, these graduate programs experienced a thirteen percent increase in foreign graduate enrollment, and this is after a substantial decade of growth in those degree programs. Unfortunately, an American legal education has less appeal to international students because an American legal education is highly dependent on the American legal system. An American legal education is not easily translatable to other country’s legal system.

This large drop off in applications to law school is strongly connected to the perceived lack of job opportunities in the legal market and much of that perception has been fueled by the rise of blogging JDs. Jewel discusses the impact of the “Anti Law-School Scam Blogging Movement” on the legal profession and the tensions it has created within among the legal community. It is not difficult at all for one to discover threads, memes and new articles discussing the bleak job opportunities new grads face coupled with the prospect of paying back large amounts of student debt taken on to complete law school. These bloggers have claimed their former institutions mislead them into thinking there were rosy career prospects at the end of law school, only to be left unemployed or working at jobs making a fraction of what they were promised outside of the legal profession. They have impacted current law students and potential law students by using a style that aims to shame law schools through the use of vitriolic blog posts. The impact this network has created clearly is beginning to show itself as law schools are struggling to find enough applicants to fill their classes. In fact, the class of 2015 at the University of Minnesota Law School was considerably smaller than the class of 2014 (of which I am a part of), due to the smaller applicant pool my school was faced with.

In my opinion, there exists a terrible disconnect in the legal profession. My personal decision to attend law school did weigh the potential of bleak career prospects before I ultimately decided on attending law school. Now as an insider of the law school community, I find the picture painted by these bloggers to be somewhat different than reality. The two biggest platforms that the bloggers have rested their thesis on according to Jewel are “that law schools are producing an oversupply of lawyers and law schools have purposely over-inflated post-graduation employment data in order to draw in more law students, and that, in essence, law schools and professional institutions, such as the American Bar Association (ABA) should be ashamed of themselves.” While post-graduation employment data has not been proven to be misleading nor has it been proven innocent, it is a topic I will choose to avoid for purposes of this blog. My main contention is with the argument of an oversupply of lawyers in the United States. Currently, there exists a severe shortage of legal help for low-income individuals. New York State’s chief judge, Jonathon Lippman, has responded to this by moving ahead with a groundbreaking rule requiring law students to perform 50 hours of pro bono legal services as a condition of admission to the state bar. Other states are seriously considering this requirement as well. Furthermore, according to Gillian K. Hadfield, professor of law and economics at the University of Southern California, there is a mismatch between demand and supply. She went on to say, that there is exploding demand for legal services for “ordinary folk lawyers” and “big corporate ones.”

To me, like Professor Hadfield believes, there is an atmosphere of feast or famine in the legal profession. Law students lucky enough to receive a high paying internship with a corporate law firm find themselves with high paying internships and post-graduation salaries in the six figures, but public interest and low income legal work often results in unpaid internships and extremely low paying full time positions, commonly below $40,000. Additionally, temporary doc review jobs with terrible working conditions and low paying hourly work muddle the market even more. It is not the oversupply of lawyers that has resulted in bleak career opportunities but a failure by the legal community to create business models that adequately address demand. There is demand from large corporations, who are dissatisfied with the high fees and unsatisfying results produced by large firms, for good attorneys according to Hilliard. Also legal access for “ordinary folk” is extremely strained; there simply aren’t enough attorneys in this line of work to satisfy demand. This is something I have experienced personally, as I am constantly helping my parents find an attorney for their small business who can work on their legal issues in a timely fashion, not an easy task. They have yet to find a good attorney who isn’t overwhelmed by the amount of work they have on their plates. This indicates to me that there is a large amount of demand, at least for good attorneys for small businesses, and the legal profession has failed to keep pace.

A disconnect between the supply of attorneys and the demand for their services is apparent. Too many students are forced to compete for relatively few big law jobs that pay enough to make a legal education a sound investment. The demand for attorneys for small businesses and individuals is high but current legal professions have skewed the funneling of new attorneys to fields of law in oversupply. There is much discussion of change at the education level of the legal field, but no one is discussing the change at the professional level. The legal field has to change the way it does business. Big law firms are not in a rush to change because they continue to enjoy profitability, and their partners regularly take home checks in the seven figures. But big law shouldn’t be required to carry the responsibility of leading; they have a successful business model. Solutions must come from individuals within the legal community to match unsatisfied demand for legal services with an adequately compensated supply of attorneys. When the catalyst for change will come is unclear, but maybe the drastic fall in law school applications will serve as the catalyst for change, or it could exasperate the situation further, but one thing is certain, the demand for affordable and quality legal services does exist.

Discussing the Legal Job Market Online: Optimism, Observation, and Reform

March 12, 2013
Legal Education, Social Media

by Elliot Ferrell, UMN Law Student, MJLST Staff

The average law student incurs $125,000 of debt and pays almost twice as much in tuition as a student did in 2001. Law students are understandably concerned with the legal market’s job prospects, and many are vocal about. Students are not the only ones voicing their concerns, as a lawyers (employed and unemployed), professors, employers, and business people add their opinions and observations to the discourse as well. A common theme is to decry the rise of tuition costs and debt and the fall of enrollment and job openings.

The Minnesota Journal of Law, Science and Technology’s publication, You’re Doing It Wrong: How the Anti-Law School Scam Blogging Movement Can Shape the Legal Profession, describes this dialogue with a sense of optimism. According to the article, unemployed and underemployed lawyers contribute to the legal community through the voice of an outsider, facilitated by the openness and anonymity afforded by the internet. These contributions may contain valuable ideas and observations but are often plagued by gripes and vulgarities so common to internet communications emanating from forums or the blogosphere.

Additionally, the online news world is littered with articles espousing reasons for the gloomy outlook in the legal job market. However, many carry the same sense of optimism as previously indicated. One such article suggests that, after using a little math and some average attrition rates, the number of law school graduates per year and the number of job openings per year will equalize by 2016. This result is due to dwindling average enrollment and approximately equal number of graduates getting jobs each year. Despite the apparent logic of this approach, holding onto all of the variables involved staying the course likely requires an ardently optimistic law student.

Several commentators step back from the optimistic approach and suggest reforms intended to curb the cost of law school and increase a graduate’s job prospects. One proposal would remove the third year of law school to cut the tuition debt and hasten a student’s path into the workforce. However, such an idea is not without its pitfalls, such as a reduced readiness for the bar exam. Another idea is to increase practical education through clinical courses and partnerships analogous to medical residencies. Many schools already offer an array of different clinic experiences, but the notion of a legal residency would seem attractive to law students as it would offer an additional path to permanent employment.

What is the role of the student in this discussion? Perhaps, it is to let it run its course and hope for the job market to right itself. Perhaps, it is to chime in and advocate or simply make observations. Either way, there are certainly valuable contributions to be made, and, with access to the internet, there is little standing in your way.

New Medicine Into Old Bottles, Quality and the US Medical System

March 12, 2013
Healthcare, Healthcare Reform, Public Health

by Eric Nielson, UMN Law Student, MJLST Staff

This entry discusses some of the challenges identified in Grout et al.’s article Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications from Volume 14.1 of the Minnesota Journal of Law, Science, and Technology. If you don’t have any health problems, have family with health problems, or pay taxes then the problem probably doesn’t impact you. The rest of this paragraph is about me establishing my credentials on the subject, if you don’t care, feel free to skip ahead. I have worked as an R&D engineer developing medical devices for more than 15 years. I have a Masters in Medical Engineering from the University of Washington. I am an inventor on several medical device patents. I have worked for a very large company and for several startups. I have conducted market research, physician training, product design, FDA filing preparation, process development, product development, and implementation, etc. I have worked at nearly every stage of medical device development. Devices I have worked on are in literally millions of people in the United States.

The medical delivery system in the United States is fundamentally unchanged in its approach to quality management since the sixties, with the notable exception of anesthesiology (consider how, malpractice pressure forced reform of anesthesiology in the 80s). The public sector of our economy had to make major revisions when foreign competition in the eighties meant that domestic manufacturing could not compete with other countries. American automotive manufacturers took it in the chops because they could not effectively compete with Japanese and Korean companies. Only in the last decade have the automotive manufactures achieved economic efficiencies similar to their competitors (and finally shed some of their legacy costs). Hospitals and private practices never had this wave of foreign competition and so have never had to reinvent themselves to stay in business. Hospitals are heavily subsidized both directly by the taxpayer and through the federal system. The result has been local monopolies with limited real competition, just like the big three automakers before the Japanese entered the picture.

Japan did not invent quality manufacturing. Japanese industry was known for cheap, poor quality goods well into the sixties. What changed is that Japan got serious about producing quality products as a way to compete internationally and move up the value chain. To do this they relied on the work of several notable Americans: Demming, Juran (University of Minnesota graduate), and Crosby. These three together with Taguchi constitute the key founders of the discipline of Quality Management. There are some key concepts that I want to explore in relation to medical providers.

1) “Quality is free.” It is inherently cheaper to do it right the first time than to have to fix it. It is cheaper to spend more on the process to make it so reliable that you don’t have to continue to monitor the output. Your current business is probably externalizing the costs or hiding them and thus minimizes the real cost of defects in the products you make. Time and money are spent to prevent customers from knowing what the actual quality of health care provided by hospitals.

2) Nobody understands the problem better than all of us together. To find the best solution, you need to understand the system from the point of view of everyone who interacts with it. This requires that line personal have the ability to discuss problems and solutions without fear of negative job impact. This does not exist in modern hospitals. Nurses and staff doing the work are not free to identify problems or concerns with physicians. Decisions are not made with consensus but are top down, command and control by people with very limited information. This prevents identification of effective, realistic solutions and instead encourages ineffective window dressing committees.

3) Quality improvement depends on good information and systematic effort. Bluntly Medical providers have systematically hidden outcomes information in an effort to prevent the consuming public from being aware of how bad a job they’ve done. This includes not gathering the information, not publishing information they have, and playing malpractice claims to keep quiet. Take a typical medical procedure and go find the published complication rate. Then take those numbers and talk with specialists in that field about those numbers. What you’ll find is that the published data invariably understates the prevalence of complications at top flight institutions. This is generally a result of selection bias, where only data sets with exceptional outcomes are submitted for publication (so as not to reflect poorly upon the institution). In the absence of good information, these Potemkin village studies underestimate the scope and cost of the problem and encourage administrators and staff to ignore the problem. Nobody ever says Institution X published a study with only a 3% complication rate for procedure Y, we need to get our numbers to that level. They instead say, I wonder what their real rate is or I wonder how they selected their patients for that study.

4) Management needs to lead or it will not happen. This is a system problem. This is not a problem of people not doing their jobs. It is not about people not trying to do their best. The highly complex medical delivery system does not hold anyone responsible for the error rate. It doesn’t not impact salaries, reputation, or stock price the way it does at private companies. Look at the response from hospitals that are killing people every day compared with Toyota’s response to the “sudden acceleration” fiasco. Is the executive team involved? Are resources focused on the problem? Etc. FDA holds management personally, legally responsible for failures of the quality systems at medical device companies. The same standard hasn’t been applied to medical delivery systems. Maybe it’s time to apply this principle outside of Anesthesiology.

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