Health Law

Scientific Responsibility: Why Lawyers Are Imperative in Scientifically Informed Neuro-Ethics

November 5, 2014
Food and Drug Law, Health Law, Public Health

Thomas Hale-Kupiec, MJLST Staff Member

In Volume 11, Issue 1 of the Minnesota Journal of Law, Science, & Technology, Eagleman, et al. conclude that “the neuroscientific community should continue to develop rehabilitative strategies so that the legal community can take advantage of those strategies for a rational, customized approach” in Why Neuroscience Matters for Rational Drug Policy. Though perhaps this assertion is valid in the context of Drug Addiction, I believe it is necessary to limit this assertion to solely rehabilitative drug addiction studies; to allow a further extension of this conclusion would be sociologically detrimental. I postulate that beyond ideas of who we define as a “Neuroscientist,” legal experts need to be at the forefront of this debate in order to better define and formulate ideas of “rehabilitation.”

In a related reflection entitled ‘Smart Drugs’: Do they work? Are they ethical? Will they be legal?, researcher Stephen Rose poses a number of ethical and neurological impacts of mind enhancing substances. The author posits an interesting question: what is “normal” for a brain? If someone undergoes pharmacological manipulation, what should the standard be for “abnormal?” For instance, Rose poses that some substances could be used for patients with Down Syndrome to allow for cognitive enhancement. Is this a valid designation as “abnormal?” Inexorably linked to this issue would be Autism Spectrum Disorder — where on the spectrum does a cognitive “abnormality” manifest? Further, how do we define potentially less visible disorders such as “anxiety?” With this spectrum of diseases and mental health conditions, variety of measured “abnormalities,” and varying pharmacological treatment effectiveness, I think we need to be mindful that neuroscientific constructions are often blurry, but always need to be conceptualized within the paradigm of ethics.

More than ever, the question of “what is abnormal” and “what mandates treatment” needs to be addressed in pharmaceutical policy. For instance, federally designated controlled substances like marijuana may be effective at treating anxiety and other medical conditions. Should the legal community allow for Eagleman’s assertion to snowball? Imagine an increasing number of states embrace evidence that the active ingredients in marijuana could treat certain medical conditions? Should the scientific community solely argue the validity of these findings? Legal professionals, bioethicists, and regulators need to be included in these questions. It is not that the data driven outcomes need to be pursued; rather, that a level of ethics and sociological morals need to be layered above these decisions.

America’s First Flu Season Under the ACA

October 18, 2014
Healthcare, Public Health

Allison Kvien, MJLST Staff Member

Have you seen the “flu shots today” signs outside your local grocery stores yet? Looked at any maps tracking where in the United States flu outbreaks are occurring? Gotten a flu shot? This year’s flu season is quickly approaching, and with it may come many implications for the future of health care in this country. This year marks the first year with the Patient Protection and Affordable Care Act (ACA) in full effect, so thousands of people in the country will get their first taste of the ACA’s health care benefits in the upcoming months. The L.A. Times reported that nearly 10 million previously uninsured people now have coverage under the ACA. Though there might still be debate between opponents and proponents of the ACA, the ACA has already survived a Supreme Court challenge and is well on its way to becoming a durable feature of the American healthcare system. Will the upcoming flu season prove to be any more of a challenge?

In a recent article entitled, “Developing a Durable Right to Health Care” in Volume 14, Issue 1 of the Minnesota Journal of Law, Science, and Technology, Erin Brown examined the durability of the ACA going forward. Brown explained, “[a]mong its many provisions, the ACA’s most significant is one that creates a right to health care in this country for the uninsured.” Another provision of the ACA is an “essential benefits package,” in which Congress included “preventative and wellness services,” presumably including flu shots. For those that will be relying on the healthcare provided by the ACA in the upcoming flu season, it may also be important to understand where the ACA’s vulnerabilities lie. Brown posited that the vulnerabilities are concentrated mostly in the early years of the statute, and the federal right to health care may strengthen as the benefits take hold. How will the end of the ACA’s first year go? This is a very important question for many Americans, and Brown’s article examines several other questions that might be on the minds of millions in the upcoming months.

Halbig v. Burwell Revisited

September 17, 2014
Healthcare

Roma Patel, Note and Comment Editor

The Supreme Court’s decision in Hobby Lobby took the health law spotlight this summer. As the Court’s opinion was dissected every which way in the weeks following its release, something else was brewing at the Court of Appeals for the D.C. Circuit in Halbig v. Burwell.

On its face, the Halbig case challenges the federal tax credits, which are available to qualified individuals, enrolled in the health insurance exchange programs. The provision, established by the Patient Protection and Affordable Care Act, references the payment of credits to individuals who enroll through an Exchange established by the state. The legal challenge claims these credits are not available to the 36 states that chose to let the federal government manage their exchanges.

With millions of Americans relying on these tax credits in order to afford health insurance under the mandate, the case’s outcome could be devastating. One concern few are addressing is whether Halbig presents a legitimate legal question in the first place. While the plaintiff, senior policy advisor to the Department of Health and Human Services under President George W. Bush, paints this as a matter of statutory language and intent. Advocates for the ACA feel opponents are making a last ditch effort to invalidate the entire law based on imperfect legislative wording. The incessant politicization of health care reform has left most Americans frustrated and disillusioned. Regardless of the outcome, perhaps Halbig represents an opportunity to shine a light on the rhetoric surrounding the healthcare debate itself.

The High Cost of Medical Errors

March 1, 2014
Healthcare, Public Health

Mayura Iyer, MJLST Staff

When we feel unwell, or have an injury, or are battling a serious condition, we turn to doctors and hospitals to take care of us and return us to health. But what if these professionals are actually adding to the harm? A recent study in the Journal of Patient Safety stated that between 210,000 and 440,000 patients each year suffer some type of preventable harm that contributes to their death. These numbers are staggering and make medical errors the third leading cause of death in America. With statistics like that, you would expect the problem to be the topic of every major headline, however, these facts are not well documented or disseminated.

John Grout, John Hill, and Arlen Langvardt discussed the prevalence and causes of medical errors and how to mistake-proof the healthcare industry in their article in Volume 14, Issue 1 of the Minnesota Journal of Law, Science & Technology. Their article stated that medical errors stem from the multi-factorial, complex nature of medical procedures and from the subjective component of providing medical care. However, the article goes on to suggest several ways in which medical errors can be minimized through “mistake-proofing” measures that have had great success in other industries. The article gives examples of a variety of mistake-proofing methods, from using devices to monitor staff hygiene to using computers to aid the process of prescribing medication.

So why, when there are ways to tackle the issue, are the rates of medical errors not improving? Part of the problem is the institutionalized culture of healthcare. There has historically been a pass of sorts for the errors of doctors, granting them a pardon for reasonable human error. Furthermore, there is a culture of overlooking the mistakes of colleagues – partly because of a fear of retaliation and partly because there is an unspoken rule of maintaining and protecting professional reputations. However, when the cost of error is equal to the value of human life, it is necessary to break down harmful practices and implement policies that will adequately address the problem of fatal medical errors.

Academics, administrators, and doctors themselves have recognized this issue and even suggested easily to implement methods of error reduction. Dr. Marty Makary, a surgeon at Johns Hopkins Hospital, has suggested simple ideas like using cameras to record medical procedures and electronically-published reviews and ratings to make healthcare providers more accountable and thus minimize errors. With the problem only increasing, it will soon be impossible for healthcare providers to ignore. But recognizing the problem is only the first step; the more complicated task will be implementing policies that address the issue and ensuring adequate compliance. However, with the insight offered by practitioners and academics alike, the solution to this problem seems within reach.

A Farm Bill for Hansel and Gretel

February 18, 2014
Agriculture, Food and Drug Law, Healthcare, Public Health

Ke M. Huang, MJLST Staff

Once upon a time, a farmer and his new wife, who had no means to support the farmer’s first wife’s children, decided to abandon the children in the woods. These children–Hansel and Gretel–found in the woods a charming little house made of sweets. A wicked witch lived in that house.

Earlier this month, President Obama signed into law the Farm Bill of 2014. According to a New York Times article, the President called the Farm Bill a “jobs bill,” and “innovation bill,” a “research bill,” and a “conservation bill.” Yet, amid the provisions of the Farm Bill that addressed topics such as crop insurance, conservation, and trade, there were also provisions that touched on the issue of healthy nutrition of families.

Senator Stabenow (D-MI), chairwoman of the Senate Agriculture Committee and the author of the Farm Bill, emphasized that part of the Bill’s purpose was to improve nutrition choices in families. Changes such as doubling SNAP benefits (formerly called food stamps) for buying healthier foods and financing new grocery stores in underserved areas reflect that purpose.

A question remains whether the Farm Bill of 2014 will be effective in achieving that purpose. Especially for nutrition among the children, the article by Termini et al. in the Volume 12, Issue 2 of the Minnesota Journal of Law, Science & Technology offers some answers. In other words, the article addresses the predicament of modern day Hansel and Gretel who are lured by sugared snacks, french fries, and company.

In Food Advertising and Childhood Obesity (2011), Termini et al. (1) provide some alarming data about nutrition-related health complications among American children, (2) discuss the relationship between the health complications and food advertising, and (3) propose several solutions to address these health complications. While Termini et al. mention advocates of consumer choice, the authors primarily propose measures for the food industry, the government, and parents. For example, akin to the SNAP benefits for buying healthier foods, Termini et al. propose tax incentives for buying healthy food.

In final analysis, even if the often-regarded villain in the story of Hansel and Gretel is the witch, at least the government was partly responsible for the predicament of the children. Had the government funded a SNAP benefit program for the children’s family, or even subsidized the family farm through a crop insurance program, the parents would not have to leave the children alone in the woods. Just some food for thought.

Oops! They Did It Again . . .

February 4, 2014
First Amendment, Healthcare

Roma Patel, MJLST Staff
The Affordable Care Act is making its way back to the Supreme Court, this time with a different mandate under judicial scrutiny. In November the Court announced it would hear Sebelius v. Hobby Lobby Stores, Inc., regarding the comprehensive, yet controversial, health care law. Unlike National Federation of Independent Business v. Sebelius, where the Court upheld the ACA’s individual mandate to buy health insurance as a constitutional exercise of Congress’s taxing power, the Hobby Lobby case involves a religious liberty challenge against the ACA’s requirement that employers provide insurance coverage for contraception and some drugs that some believe cause abortions.

Hobby Lobby is a private corporation that owns arts-and-crafts stores throughout the country. The company is owned by the Green family, Evangelical Christians who believe that life begins at fertilization. Because Hobby Lobby is a for-profit employer of more than 50 people, the ACA will require it to provide insurance coverage of a full range contraception.

In June 2013 the U.S. Court of Appeals for the 10th Circuit ruled in favor of Hobby Lobby, stating that corporate entities are entitled to religious freedom. The 3rd and 6th Circuits split from the 10th Circuit and held that for-profit corporations do not have religious rights on two other cases challenging the ACA. On September 19, both Hobby Lobby and the 3rd Circuit case, Conestoga Wood Specialties Corp. v. Sebelius, were appealed to the Supreme Court.

Commentary on the Hobby Lobby case can best be described as dicey. Conservative and religious bloggers have hurled phrases such as, “atheist bullies” and “an attack on First Amendment rights” while the left cry, “war on women” and “crazed bible thumpers.” The broader issues at stake here are understandably divisive and extremely personal.

Amidst the often-exacerbated discussion of the case and the issues surrounding it is a desperate need to set the record straight: this is not a First Amendment issue, per se. What the Supreme Court will decide is Whether the Religious Freedom Restoration Act of 1993 (RFRA), 42 U.S.C. §§ 2000bb et seq., which provides that the government “shall not substantially burden a person’s exercise of religion” unless that burden is the least restrictive means to further a compelling governmental interest, allows a for-profit corporation to deny its employees the health coverage of contraceptives to which the employees are otherwise entitled by federal law, based on the religious objections of the corporation’s owners.

Hobby Lobby argues the provision forces it to pay for methods of contraception which the owners find religiously immoral; namely the Plan B morning-after pill, an emergency contraceptive called Ella, and two different kinds of intrauterine devices (IUDs) that may sometimes work by preventing a fertilized egg from implanting into the uterus.

Counsel for the government argues that rights to religious freedoms do not apply to for-profit corporations and that health decisions should be between a woman and her physician, there is no place to an employer to impose his or her personal beliefs on someone else’s.

Amicus briefs have been flooding the Supreme Court’s doors defending both sides of the issue. Questions of corporate personhood and whether the Court’s decision could open a huge hole in the longstanding history of religion and the practice of medicine remain relevant. For example, some religions don’t believe in blood transfusions, so does that mean business owners with such beliefs can refuse to provide insurance coverage for an employee’s transfusion? Religious beliefs are personal and deeply subjective, how can health policy makers expand on patient coverage without being at odds with subjective beliefs?

The ultimate question is whether the ACA unduly infringes on the right to religious expression or if it pursues the least restrictive means of enforcing its provision on contraception with regard to the First Amendment. The result of Hobby Lobby will be close and the case will be one to watch.

Guest Commentary – Climate Change: Is Anyone Ever Going to Do Anything About It?

February 3, 2014
Environmental Law, Public Health

by Myanna Dellinger, JD, MA – Associate Professor at Western State College of Law and Director of the Institute for Global Law and Policy

Extremely cold weather conditions still haunt the American North and Northeast. Meanwhile, California is suffering through July temperatures in January and the worst drought since 1895. No doubt about it, we are witnessing ever more frequent extreme weather events. Since nations still can’t agree on what to do about this urgent problem, it may be up to local actors such as cities, states, companies, and NGOs to take the required action now.

Nations have agreed to “try” to limit global warming to 2° C and to agree on a new climate treaty by 2015 to take effect by 2020, but in reality, we are headed towards a 5.3° C increase. Even if the 2° degree target were to be met, vast ecological and economic damage would still occur in the form of, for instance, severe economic disruptions to our food and water supply.

Disregarding climate change is technologically risky too: to meet the target of keeping concentrations of CO2 below the most recently agreed-upon threshold of 500 ppm, future generations would have to literally pull CO2 out of the air with either machinery that does not yet exist and may never become technically or economically feasible, or with bioenergy crops that absorb CO2, which would compete with food production.

My article “Localizing Climate Change” argues that effective and urgent action is likely to come from the local and not the national or international levels.

In fact, the parties to the climate treaty framework UNFCCC similarly recently agreed that cities, other subnational authorities, and the private sector must play a role in future treaty-making contexts. This makes sense. Local actors may be the ones best situated to find out what can be done technically and politically in each location. Meanwhile, nations are almost unbelievably playing two fiddles at the same time, subsidizing fossil fuel development much more than cleaner energies. That’s right: although renewable energy policies are becoming more prevalent, they are financially and politically outcompeted by the rapid growth of fossil fuels in the USA and elsewhere. Perhaps indicative of the true state of affairs is the fact that climate adaptation talks are intensifying as mitigation agreements seem to be stalling. It doesn’t help that a secretive network of conservative billionaires is pouring billions of dollars into a vast political effort attempting to deny climate change and that–perhaps as a consequence–the coverage of climate change by American media is down significantly from 2009, when media was happy to report a climate change “scandal” that eventually proved to be incorrectly reported. Little wonder that the most recent IPCC report concluded that it is “extremely likely” (i.e. with 95-100% certainty) that human activity is the principal cause of climate change.

If you think all this is driving you crazy, you may be right. Shifts in climate have been strongly linked to human violence around the world, such as spikes in domestic violence in Australia, increased assaults and murders in the United States, land invasions in Brazil, police violence in Holland, and civil conflicts throughout the tropics.

What are we, as a nation, doing about this? In the summer of 2013, President Obama announced the first-ever United States Climate Action Plan. This relies on a number of Executive Orders, as the Senate is still unlikely to ratify a climate treaty. As with other recent Congressional gridlock, this highlights the importance of local action. If the United States was willing to ratify a new climate change treaty, this could spur much-needed action by the relatively low number of nations needed to make a big impact on the problem. After all, the world’s top ten emitters account for 70% of global greenhouse gas emissions.

This leads to my questions: Where is the most likely and substantively effective action going to come from: local or national/supranational entities? If you think climate change must be countered at the national and international levels, who is then responsible? For instance, should it be the historically largest emitters (among them, the USA and China), the most capable (the industrialized world), the most progressive (arguably the EU), or . . . ? Is anything even going to happen at all, or are we as human beings simply incapable of worrying about the future as a recent study indicated?

The Affordable Care Act “Death Spiral”: Fact or Fiction?

November 10, 2013
Healthcare

by Bryan Morben, UMN Law Student, MJLST Managing Editor

A major criticism about the Patient Protection and Affordable Care Act of 2010 (“Affordable Care Act” or “ACA”) is that it will lead to a premium “death spiral.” Because the Affordable Care Act proscribes health insurance companies from discriminating against individuals with preexisting health conditions, some believe that people might just wait until they’re sick before signing up for coverage. If that happens, everyone else’s premiums will rise, causing healthy people to drop their coverage. With only sick individuals left paying premiums, the rates go up even more. And so on . . .

On the other hand, supporters of the ACA cite its other provisions to safeguard against this scenario, specifically, the subsidy/cost sharing and “individual mandate” sections. The former helps certain individuals reduce the amount of their premiums. The latter requires individuals who forego buying minimal health insurance to pay a tax penalty. The penalty generally “is capped at an amount equal to the national average premium for qualified health plans which have a bronze level of coverage available through the state Exchange.” Therefore, the idea is that enough young, healthy individuals will sign up if they would have to pay a similar amount anyway.

States that have guaranteed coverage for everyone with preexisting conditions before have seen mixed results. New York now has some of the highest individual health insurance premiums in the country. Massachusetts, which also has an individual mandate, has claimed more success. But it still leaves some residents wondering whether breaking the law might make more sense.

There are notable differences between the ACA and the Massachusetts law as well. For example, the subsidies are larger in Massachusetts than they are with the ACA, so there’s less of an incentive for healthy people to sign up for the federal version. In addition, the ACA’s individual mandate seems to have less of a “bite” for those who elect to go without insurance. The penalty is enforced by the Treasury, and individuals who fail to pay the penalty will not be subject to any criminal penalties, liens, or levies.

Finally, the unveiling of the HealthCare.gov website, a health insurance exchange where individuals will learn about insurance plans, has been a catastrophe so far. There is also some concern that “only the sickest, most motivated individuals will persevere through enrollment process.” Since high enrollment of young, healthy participants is crucial to the success of the marketplace, the website problem, and any negative effect it has on enrollment, are just the latest contributor to the possible looming spiral.

In all, it remains to be seen whether the Affordable Care Act will succeed in bringing about a positive health care reform in the United States. For an excellent discussion on the ACA’s “right to health care” and additional challenges the law will face, see Erin C. Fuse Brown’s article Developing a Durable Right to Health Care in Volume 14, Issue 1 of the Minnesota Journal of Law, Science & Technology.

Is Obesity a Disease?

October 4, 2013
Healthcare, Public Health

by Katelyn DeRuyter, UMN Law Student, MJLST Note and Comment Editor

The fact that many Americans are obese is hardly news. Obesity in America has been a source of news reports, social commentaries and literature for well over a decade. In her book review of “The Omnivore’s Dilemma: A Natural History of Four Meals” by Michael Pollan, published in Issue 8.1 of the Minnesota Journal of Law, Science & Technology, Morgan Holcomb discusses how obesity rates in America were part of Pollan’s motivation to write “The Omnivore’s Dilemma.” More recently, American obesity has been described as an epidemic, and the health risks associated with obesity are gradually becoming common knowledge. Obesity is even compared, by some, to smoking and alcoholism. A recent LawSci blog post, “Is Food the New Tobacco: Science, Advertising, and the War against Obesity?” looks at Roseann Termini’s article, “Food Advertising and Childhood Obesity: A Call for Action for Proactive Solutions,” and draws parallels between the role of advertising in the rise of cigarette addiction and the current obesity epidemic.

A question that is overlooked in this dialogue is whether obesity is, in fact, a disease. Whether obesity is considered a disease has real consequences including altering social stigmas, increasing funds allocated for research and expanding treatment accessibility. The debate over whether obesity should be considered a disease is not new. However, new life has been breathed into the debate following the American Medical Association’s (AMA) official recognition of obesity as a disease. The New York Times quoted Dr. Harris, a member of the AMA’s board, as stating that “[r]ecognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately one in three Americans.” A recent Forbes article, “Declaring Obesity a Disease: the Good, the Bad, the Ugly,” provides a closer look at how the AMA reached its decision.

In reaching the conclusion that obesity is a disease, the AMA overruled its own council’s recommendation. The AMA’s Council on Science and Public Health (Counsel on Science) had been tasked with studying this issue over the past year. The Council on Science’s recommendation against categorizing obesity as a disease rested, in part, on the concern that body mass index (BMI) is a simplistic and inaccurate tool; BMI is the tool generally used to define obesity. The Council on Science was also concerned that recognizing obesity as a disease might increase reliance on drugs and procedures and decrease the emphasis on lifestyle changes.

From a legal perspective, this classification raises interesting questions regarding future interpretation of Congressional intent when “disease” is used without a specific definition. While only time will be able to tell the actual effects of this classification, this is certainly a “must watch” area for health law attorneys.

Country of Origin Labeling for Food and Pharmaceutical Products

September 26, 2013
Agriculture, Food and Drug Law, Health Law, Public Health

by Daniel Schueppert, UMN Law Student, MJLST Staff

The USDA has recently lifted restrictions on the practice of shipping US Chicken to China for processing, for an eventual return to the US. Under the present regulations, chicken originating from US farms can be shipped to China for processing, then shipped back to the US for sale. This chicken need not include Country of Origin Labeling (COOL) to indicate that it has been processed in China. This change comes in the wake of a years of food safety scares relating to China’s food supply. Although the Food Safety Inspection Service (FSIS) has completed audits of the China’s “poultry processing inspection system” and certified some of the Chinese processing plants and procedures, American consumers have retained some reservations about the safety of chicken processed in China. As it stands, this system leaves consumers in the position of not knowing which country their chicken products have been processed because the Chinese operations are considered a comparable food component to what results from US processing.

This recent action by the USDA clearly raises questions concerning the United States’ food safety, and perhaps security. A sophisticated consumer may nevertheless be able avoid chicken products known to be processed in China, but absent COOL disclosures this may be a difficult task and arguably involve some guess work. This is not necessarily the case with generic pharmaceuticals, an area in which there are substantial parallels to the chicken debate. Some of the concerns raised relating to the quality and safety of chicken processed in China also bring to light the COOL requirements for other consumables like pharmaceuticals. Import screening and labeling for pharmaceuticals, and particularly off patent generics, is a convoluted area of regulatory law where Federal agencies to not always agree. Currently many of the various components of just one pharmaceutical drug are manufactured all over the world and come from a variety of sources. Manufacturing in India, China, and Eastern Europe account for a large part of the market.

The FDA’s main measure on determining the quality of components in generic drugs is a fuzzy spectrum concerning the “bioavailability” of certain chemicals but this measure does not necessarily take account of inert components or varying quality or quantities of active ingredients. Much like chicken, a consumer or regulatory agency would be hard pressed to find a problem with these products until a quality control issue develops and American consumers are put at risk. COOL labeling regarding Chicken and Drugs are developing issues without a clear regulatory action in sight. Stay tuned to the Minnesota Journal of Law, Science & Technology for further updates.

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