2016

The Path of Pollutants Under the Clean Water Act

March 19, 2016
Environment, Environmental Law, EPA

Ted Harrington, MJLST Staffer

In 1972, the Clean Water Act set forth a lofty goal—to “[r]estore and maintain the chemical, physical, and biological integrity of the nation’s waters.” (33 U.S.C. §1251(a)). Yet, the Clean Water Act only regulates point sources that discharge pollutants into navigable waters (33 U.S.C. §1251(a)(1)). As a result, many forms of water pollution escape federal jurisdiction, most notably, groundwater. This is because CWA regulation depends on how a pollutant reaches navigable water, instead of focusing on the end result. This added constraint is hardly logical when juxtaposed against the stated goal.

For example, if a pollutant is discharged into groundwater, and eventually reaches navigable Water Body B, the CWA does not have the ability to regulate the groundwater. In other terms, if the polluted effluent passes through groundwater, considered a “nonpoint source,” before it reaches Water Body B, no CWA regulation occurs.

To combat this issue, Federal District Courts in Hawai’i, North Carolina, and Pennsylvania have begun adopting the “Conduit Theory” (See Allison Kvien note Volume 16). The conduit theory states that if a body of water (groundwater) simply acts as a conduit, it should be viewed as an extension of the point source from which it is receiving the pollutant. This theory directs its attention to the ultimate result—the pollution of Water Body B. It is only logical that if Water Body B is being polluted, the source should fall under CWA jurisdiction. Why should we leave a source of pollution unregulated simply because the effluent isn’t being directly discharged into a navigable water? As the Court in Rapanos v. United States noted, “The [Clean Water] Act does not forbid the ‘addition of any pollutant directly to navigable waters from any point source,’ but rather the ‘addition of any pollutant to navigable waters.’”

The issue of groundwater as a pollutant is receiving increasing attention in the courts. In the Northern District of Iowa, a case concerning the discharge of groundwater through tile drains is currently in litigation‑ Board of Water Works v. Sac County Board of Supervisors. This could be an opportunity for Iowa to take one of the first stances on the conduit theory in the 8th Circuit. Stay tuned!

Geostationary Earth Orbit: Property for the Space Age

March 10, 2016
Property Law, Space Law

Ian Blodger, MJLST Note & Comment Editor

The past several years have seen great advances in space based technology and exploration. Most recently, scientists used the LIGO to prove the existence of gravitational waves. While the two detectors used to make this discovery were located in the United States, scientists have plans to deploy more advanced and precise measuring tools in space, likely in Geostationary Earth Orbit (GEO). GEO’s unique properties make it a perfect choice for this and similar satellite technology. Essentially, GEO is an orbital path around Earth where satellites remain in a fixed position above a specific point on Earth. This aspect of GEO makes it easier for the satellite to communicate with Earth based operations because the satellite operator does not need tracking technology to follow the satellite, but can simply build a stationary receiver. One additional result of GEO is that satellites that enter this orbital path remain there forever unless they are pushed out of orbit somehow. This is distinct from satellites in Low Earth Orbit (LEO) where satellites are not fixed above one point on Earth and remain for only a few years. This gives GEO satellites an additional advantage of reducing costs over the long term because operators do not need to replace them with the same frequency as LEO satellites. With the special conditions and long term cost savings of GEO, it is no wonder that more and more satellite operators and manufacturers are interested in placing a satellite in GEO.

One issue that will become more important as satellite operators continue to utilize GEO’s special attributes is the issue of property rights. Currently, satellite operators who place a satellite in GEO have no property right over that orbital position. In my Note “Reclassifying Geostationary Earth Orbit as Private Property: Why Natural Law and Utilitarian Theories of Property Demand Privatization,” recently published in Volume 17 of the University of Minnesota Journal of Law Science & Technology, I argue that this lack of a defined property right is both contrary to the underlying theoretical assumptions of various space treaties, and that granting a property right would be a good idea from a utilitarian perspective.

Allowing individuals to obtain property rights over a region of space makes sense from a natural law perspective. The various space treaties cite natural law for the proposition that an individual cannot own space, likening the vast emptiness to the sea. Under traditional natural law theory, the sea is not subject to homesteading and other means of property acquisition because it is so large and is not capable of being contained. However, Grotius, the natural law philosopher most responsible for this theory argued that when an area of the sea was slightly separated and could be wholly controlled, then property rights could exist.

While space generally is more like the uncontrollable sea, GEO is more akin to small inlets capable of control. First, GEO only comprises a small area of space; if satellites are too close to Earth or too far, they will not maintain their synchronicity with the planet’s rotation. Second, objects placed in this orbit will remain in a fixed position relative to the Earth. This is different than a ship on top of the ocean that moves with the waves and tides relative to shore. Finally, individuals who place satellites in orbit expend large amounts of money and energy to do so, and therefore meet the labor requirement expressed by both Grotius and Locke’s theories of property.

Granting property rights over certain portions of GEO makes sense from a utilitarian approach as well. This approach to property looks to see whether leaving things in common causes more harm than benefits. In this case, the tragedy of the commons has caused large costs and dangers that could be rectified by allowing GEO property rights. First, without property rights, individuals have little incentive to ensure their satellites leave orbit after failure. Under the current approach to GEO, satellite operators have little incentive to move their satellites to a graveyard orbit following failure because they can obtain another, similar, GEO position and do not have to worry about selling the inhabited position at a loss. With property rights over these positions, there would be a great incentive to move the satellite to a graveyard orbit to secure the best price for the position. Second, because no satellite operator has a property right which is harmed by space debris in the area, manufacturers create a race to the bottom in terms of quality parts, which in turn results in malfunctions and potentially more debris in the area. This leads to debris defense costs, such as special plating to deflect debris, that add up over the long term. Thus, a utilitarian approach to property yields the same result as the natural law: satellite operators should obtain a property right over GEO.

This is an interesting and fast moving area of law, and the decisions we make now can have great impacts on the future of space operations, especially considering debris in GEO will remain there forever.

Drug Shortages: A Mask for Reprehensible Activity?

March 10, 2016
Competition, Drug Policy, Economics, Healthcare

Ethan Mobley, MJLST Articles Editor

Access to life-saving prescription medication grabbed headlines after Turing Pharmaceuticals raised the price of its HIV drug, Daraprim, by about 5,000% overnight. While the Daraprim price hike initially appears to be driven by pure greed, it’s at least conceivable that basic economic principles of supply and demand may have played a minor role. Indeed, many other drugs have undergone serious price hikes arising from innocent supply constraints. While the defensibility of Daraprim price hikes remains uncertain, the story does bring to focus an issue affecting accessibility of hundreds of other life-saving prescription medications—drug supply shortages.

Drug shortages naturally restrict many patients’ ability to obtain life-saving medication, which can have disastrous effects. The Minnesota Journal of Law, Science & Technology addressed the issue in 2013 with a note written by Eric Friske. Friske found that drug shortages are often caused by a “combination of perturbed supply, manufacturing capacity, and utilization.” Friske then analyzed the efficacy of proposed (and now failed) legislation meant to reduce these supply shortages by requiring manufacturers to notify the FDA of impending shortages; the legislation would have also allowed the FDA to collaborate with manufacturers in order to streamline production. However, Friske determined these tools were insufficient to properly combat the shortage problem and proposed his own solution. In addition to notification requirements, Friske pushed for affirmatively incentivizing manufacturers to produce certain drugs and streamlining the drug manufacturing approval process.

Since Friske’s proposal, we’ve seen new legislation and regulation that aims to reduce the number of drug shortages. What’s more, the legislation and regulations contain notification requirements, manufacturer incentives, and streamlined approval processes—just like Friske proposed. While it’s obvious the drug shortage problem has not been solved, it is equally clear drug shortages have decreased over the past few years. Hopefully the trend continues so that life-saving drugs remain accessible to everyone, and drug companies will no longer be able to use supply shortages as justification for obscene price hikes.

Compulsory Licensing and Health Law

March 10, 2016
Competition, Drug Policy, Healthcare, Intellectual Property

Nolan Hudalla, MJLST Staffer

In her articleA Public Health Imperative: The Need for Meaningful Change in the Trans-Pacific Partnership’s Intellectual Property Chapter, Roma Patel discusses the benefits that TRIPS “flexibilities” provide to the pharmaceutical markets in developing nations. Specific to this discussion, Ms. Patel notes that malaria is a permissible reason for a country to declare a “national emergency” or “circumstance of extreme urgency” under TRIPS. Such a declaration would allow a nation to utilize the TRIPS compulsory licensing provision. This permits “a government to allow the sale and manufacture of patented medicine without the patent holder’s consent.” With the recent development of aviable malaria vaccine, what can we expect the impact of this provision to be? In particular, will countries invoke compulsory licensing on the basis of a malaria “national emergency,” and, if so, what results can we anticipate?

According to history, we can’t expect much. According to Nicol & Owoeye, “[t]o date, there is little to suggest that the Implementation Decision and the Protocol [for the compulsory licensing provisions] can meaningfully contribute to reversing the failure of the industrialized world to supply essential medicines to the countries that need them the most. Nor does there appear to be widespread enthusiasm for using Implementation Decision and Protocol mechanisms to facilitate the provision of low-cost or no-cost pharmaceuticals to those most in need.” This certainly appears to be true for impoverished African nations. For example, the continent has already been devastated by the HIV/AIDS epidemic, yet compulsory licensing has not provided a sufficient solution. In fact, according to a UNAIDS report, “[o]f the 21.2 million people in Africa eligible for antiretroviral therapy in 2013 under the 2013 WHO guidelines, only 7.6 million people were receiving HIV treatment as of December 2012.”

Brian Owens’ article Questions Raised about Whether Compulsory Licenses get Best Pricesdiscusses one of the reasons for the disappointing results of compulsory licensing. He notes that “[t]he use of so-called ‘compulsory licenses’ by developing countries to obtain cheaper drugs for HIV and AIDS by circumventing patents has not been the best strategy for achieving the lowest prices over the past decade . . . .” Expanding on this, Owens states that, “of the 30 cases of compulsory licensing from 2003 to 2012 for which reliable data was available, the median price achieved through international procurement was lower for 19 of them [than compulsory licensing]—in the majority of cases by more than 25% . . . . The effect was strongest in the poorest countries, where in six out of seven cases the procurement price was more than 25% lower than the compulsory license price.” Amir Attaran, the director of the study discussed in Owens’ article, asserts that “countries should not rush into using compulsory licenses until they have exhausted all other options. “Countries can save money using compulsory licenses, but they can save more by negotiating and using international procurement channels . . . If saving money is paramount, then compulsory licenses may not be the optimal strategy.”

Unfortunately, saving money is paramount for many African nations. Thus the greatest “flexibility” given to these nations is not always a practical solution. Perhaps the arrival of the first malaria vaccine will motivate international leaders to learn from prior experience. Hopefully the international community will reconsider compulsory licensing, as Roma Patel did, to determine how it can better provide access to life-saving medications.

U.S. Letter to Google: A Potential Boost for Self-Driving Cars

February 26, 2016
Autonomous Vehicles

Neal Rasmussen, MJLST Managing Editor

As Minnesota Journal of Law, Science & Technology Volume 16, Issue 2 authors Spencer Peck, Leili Fatehi, Frank Douma, & Adeel Lari note in their article, “The SDVs are Coming! An Examination of Minnesota Laws in Preparation for Self-Driving Vehicles,” current laws already permit certain aspects of self-driving cars, but these laws will need to be modified to allow self-driving cars to reach their full potential. While the process will be slow, this modification is starting to happen as evidenced by a recent letter sent to Google, Inc. from the National Highway Traffic Safety Administration (NHTSA).

In this letter, Paul Hemmersbaugh, writing as chief counsel for the NHTSA, accepts the fact that the computers driving Google’s self-driving vehicles can be considered the same as a human driver such that the “NHTSA will interpret ‘driver’ in the context of Google’s described motor vehicle design as referring to the [self-driving system], and not to any of the vehicle occupants.” Mr. Hemmersbaugh further explains that the NHTSA “agree[s] with Google [that] its [self-driving vehicle] will not have a ‘driver’ in the traditional sense” and that the NHTSA must work to develop better rules moving forward.

This letter was in response to Google’s proposal for a self-driving vehicle without basic controls, such as a steering wheel and pedals, and ultimately no human driver. The proposal stems from Google’s belief that having features that allow humans to take control could be “detrimental to safety” because human drivers are often ill equipped to take over in emergency situations due to distractions and over reactions.

According to Karl Brauer, a senior analyst for Kelly Blue Book, if the “NHTSA is prepared to name artificial intelligence as a viable alterative to human-controlled vehicles, it could substantially streamline the process of putting autonomous vehicles on the road.” While this letter is definitely a step in the right direction, manufacturers still have a long ways to go at the state and federal levels.

In December the California Department of Motor Vehicles (DMV) issued proposed regulations that would require a human driver to always be behind the wheel with the ability to take over controls at any time. The DMV expressed concerns that manufactures haven’t obtain enough experience with driverless vehicles on public roads and that more must be done before such technology can be readily available.

So while the letter from the NHTSA offers hope to those within the industry, there are many more barriers to be crossed before self-driving cars can become a full reality.

Culpability in Criminal Law and the Emerging Field of Neuroscience

February 26, 2016
Criminal Law, Neuroscience

Daniel Mensching, MJLST Staffer

Criminal law has long held that people are accountable for their behavior and that most behavior is intentional and conscious. This is necessary for the legal system to determine culpability and therefore warrant punishment. In his article Blaming the Brain, Seven K. Erickson explores how the still young field of cognitive neuroscience is beginning to challenge traditional notions of free will independent action and potential legal consequences of this shift in understanding. While the implications for emerging understandings of neuroscience are far-reaching and delve into areas such as psychology and philosophy, viewing human actions as mechanical and absent of free will raises serious questions in the field of law as well, especially criminal law.

Cognitive neuroscience, though still in its infancy, holds the potential to explain all human behavior as a result of involuntary processes occurring within the brain. According to Erickson, cognitive neuroscience leads us to the view that “we are a passive audience to the electrical cadence of neuronal firings buried deep within our heads” and that “what we perceive as the mind is nothing more than a cognitive adaptation established by our brains to allow higher-ordered behavior.” This view is entirely incompatible with the notion of human agency that holds that people evaluate their environments and make choices.

Many exceptions are already made, both in the legal system and in general, for people with certain mental defects. While some defects are obvious, the list of recognizable mental disorders is growing rapidly. The number of official diagnosable mental disorders has increased by almost 300% in the past 50. Behaviors that were once considered indicative of poor character are now considered medical disorders. What could have been considered laziness or immaturity 50 years ago can now be treated with a prescription for amphetamines, a drug considered addictive and dangerous and is therefore illegal for the general public. Many of these diagnoses are made based on inherently subjective criteria. Criminal law already contains the affirmative defense of insanity, and cognitive neuroscience begs the question of how and to what extent neurological conditions should influence culpability and punishment.

But the criminal system is not aimed solely at punishing for the sake of justice. Another main goal of criminal law is to reduce crime in society, both by deterring would-be criminals and by reducing recidivism. While understanding human behavior as simple mechanics may make punishment seem irrational, cognitive neuroscience aims to ameliorate the criminal justice system by understanding the causes of criminal behavior and therefore being able to effectively predict crime and rehabilitate offenders.

3D Food Printing and Its Legal Complications

February 17, 2016
3-D Printing, Food and Agriculture

Riley Conlin, MJLST Staffer

According to a recent article in Bloomberg, the FDA has recently approved the use of a drug that was 3D printed for the first time. The first drug the FDA approved is Spritam, which was created by Aprecia Pharmaceuticals. The drug is to be administered orally to treat adults and children for epilepsy. The 3D printing process supposedly allows the pill to dissolved quickly, which means it will enable the pill to act faster in the case of an oncoming seizure. When this approval occurred several attorneys voiced concern, because of the intellectual property issues related to 3D printing. First, it would be difficult to determine the manufacturer of the drug, making the assignment of IP rights quite challenging. Second, because it would be difficult to determine the manufacturer, it would also be difficult to identify liable parties in potential litigation.

While there are undoubtedly legal issues related to 3D printing, a forthcoming article in the Minnesota Journal of Law Science and Technology Symposium argues that the benefits far outweigh potential legal issues that could slow the adoption of 3D technology in the area of food production. Symposium author, Jasper Tran, notes that there are “endless possibilities” associated with 3D food printing. First, the ability to print food has the potential to significantly impact the global food shortage crisis, because healthy food can be mass-produced via 3D printers. He also argues that 3D printing has the potential to reduce environmental harms associated with current food production. However, he does note that there are legal liability issues with 3D printing, including (1) short-term food poisoning on an individual scale or mass scale and (2) long term impacts of food printing. Despite these concerns, Tran argues the legal risks are far outweighed by the potential global benefits of mass-producing food via 3D printers.

As discussed in the Bloomberg article and in Tran’s note, 3D food and drug printing is the future. It is the responsibility of government organizations to take a proactive approach and attempt to enact rules and regulations that anticipate the new legal issues and challenges associated with the process.

The Threat of Antibiotic Resistance: The Use of Antibiotics in Animal Agriculture and Proposed Regulations to Increase the Involvement of the Food and Drug Agency

February 17, 2016
FDA, Food and Agriculture

Jody Ferris, MJLST Staffer

Antibiotic resistance purportedly caused by the immoderate use of antibiotics in animals raised for human consumption is currently a hot button issue in the news today. It is an issue important to human health and to the food and agriculture industries.   In her note, Slowing Antibiotic Resistance by Decreasing Antibiotic Use in Animals, Jennifer Nomura discusses this issue and makes recommendations regarding which government agency should regulate antibiotic use in animals and how it should best be regulated.

According to Nomura, antibiotics that had been used to treat animal diseases are also being utilized for growth purposes. She says that, “it is now common in the United States for farm animals to be fed low doses of antibiotics on a daily basis.” The species in which antibiotic use is most common are pigs and poultry. She states that “[b]ecause farmers have been feeding antibiotics to animals for so many years, animals are becoming resistant to the effects of these drugs.”   She also states that it is also possible for the antibiotic resistant bacteria in animals to pass to humans and that, “as humans become resistant to antibiotics, health care for treatable diseases becomes more costly. Antibiotic resistance can lead to hospitalization, longer-term care, and potentially even death.” However, despite the grave risk that antibiotic resistance poses, Nomura states that “no direct connection has been established” between antibiotic use in animals and antibiotic resistance in humans. Some studies have showed a causal link between the two.

Over the course of her note, Nomura argues convincingly that the primary authority for the regulation of antibiotic use is the Food and Drug Agency in connection with the United States Department of Agriculture and the Center for Disease Control, along with the World Health Organization and the European Union. She proposes that the Food and Drug agency should enact a full scale ban on the animal use of any antibiotic that is also used in the human population. Her note also suggests that the Food and Drug Agency should then establish a monitoring program to keep an eye out for any threats posed to human health through the continued use of antibiotics that would not be covered by the ban.

One regulation that has since been promulgated by the Food and Drug Agency since Nomura authored her note, is the Veterinary Feed Directive rule. This rule will require agricultural producers to get prescriptions for the animal use of antibiotics “considered important to human health, such as penicillin or sulfa” (see Nikki Work’s article Veterinary Feed Directive Will Impact Whole Livestock Industry, But Many Aren’t Aware of the Regulation at http://www.greeleytribune.com/news/20358154-113/veterinary-feed-directive-will-impact-whole-livestock-industry#). The rule will be fully implemented on Jan. 1, 2017.

While the above regulation does not go so far as Nomura’s proposal to ban all antibiotic use in animals when the medications may also used for human health purposes, it is a step in the direction of increased oversight of antibiotic use by the Food and Drug Agency. It will certainly be interesting to follow future regulations in this area as they appear on the horizon, and how the Veterinary Feed Directive impacts antibiotic use and food production.

Name That Star

February 17, 2016
Space Law

Quang Trang, MJLST Staffer

For space lovers out there, the opportunity to name a star after a loved one sounds like a nice romantic gift for Valentine’s Day. The issue of whether this is actually allowed is somewhere between yes and no.

The main authority in naming astronomical objects is the International Astronomical Union (IAU). The goal of the IAU when formed in 1919 is to “to promote and safeguard the science of astronomy in all of its aspect through international cooperation.” Part of the IAU’s authority in its scientific mission promoting and safeguarding astronomy is the duty of being “the arbiter of planetary and satellite nomenclature.” In normal English, the IAU is the organization that decided Pluto does not qualify to be a planet.

Although the IAU is the leading authority in astronomical nomenclature, the organization still refuses to commercialize outer space by selling the rights to name space objects, such as stars. Due to the IAU being an international scientific organization, it does not have the authority nor the interest in outlawing such a practice. There are many services that would allow you to pick an unregistered star and name it for a fee. However, these multiple services are unrelated and have different databases. Essentially, a star you named with one service may be already be registered under a different name with a different service. Prominent star-naming services such as the International Star Registry are aware of its unofficial status. Rocky Mosele of ISR said “I think people are OK that it’s not official. I’m sure of it. I know because customers call again and again and again.” The ISR’s claims to not mislead any of its customers because it never once claimed to be official.

With each registration costing as much as fifty dollars, one might ask why the IAU does not participate in such a business. The organization would be an industry leader with the ability to give these registered names official status. The proceeds could be used to fund various projects. After receiving many requests to from private individuals to name stars, the IAU explains its policy to stay out of such an enterprise: Thus like true love and many other of the best things in human life, the beauty of the night sky is not for sale, but is free for all to enjoy.

The Affordable Care Act, Meant to Increase Medical Care Accessibility, May in Practicality Hurt That Accessibility Through Narrow Networks

January 28, 2016
Competition, Healthcare, Healthcare Reform

Natalie Gao, MJLST Staffer

The Patient Protection and Affordable Care Act (PPACA) continues to perpetuate some of the issues of medical inaccessibility it was meant to fix. The PPACA uses insurers’ desire to dodge risk to make health insurance more widely available, preventing insurers from refusing coverage based on preexisting conditions and requires they guarantee renewalability without too extensive a waiting period. Although PPACA disincentive insurance companies to risk-select, insurance companies found new ways to compete.

Narrow Networks, the Very Sick, and the Patient Protection and Affordable Care Act: Recalling the Purpose of Health Insurance and Reform by Valarie Blake discusses the creation of narrow networks by insurance companies as new ways to compete, where insurance companies agree to better rates with a narrow group of providers. This allows them to give better prices and premiums to its customers, even if the potential consequences is that the customers actually end up with more restrictive coverage. PPACA theoretically regulates networks, guaranteeing network adequacy of by a minimum standard of care and that the network be with essential community providers. But PPACA does not require network adequacy of providers. Practically, narrow networks can affect the availability of specialize services that some patients need, and the quality and experience of those providers. Even if the need to compete for patients might also ensure that narrow networks never compromise the necessary care, tertiary and specialty care, and the quality of care and connection due the provider, can easily be limited.

“Network adequacy,” states Blake, “is not a debate about access of health insurance but rather access of healthcare.” One way to measure whether or not our health care system is doing what it is supposed to is to measure the health of the very sick, and it brings up the question of whether or not PPACA guarantees all the right of healthcare or the right to be healthy. And what does count as sufficient access and who should be responsible for paying the healthcare costs associated with that sufficient access? These questions evoke analysis for consumer choice and consumer rights. The article recommends that network adequacy standard in both State and Federal law include tertiary and specialized care, and not extra cost be added onto out-of-network care, and the article recommends a special standard for tertiary care be adopted into law. On principle and based the cases that have occurred already around PPACA, narrow networks can easily become an issue that, if left unregulated, can create the very thing it was meant to solve.

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