Treating Depression with Ketamine? How The Investment Was Made

March 15, 2019
Biotechnology, FDA, Food and Drug Law, Health

Hunter Moss, MJLST Staffer

Depression is a serious mental disorder that afflicts millions of Americans each year. One in three of these individuals struggles to find a treatment method that alleviates their condition, and are aptly said to suffer from treatment-resistant depression. In the most severe cases, treating depression can be a life or death decision—depression is the leading cause of over 41,000 suicides every year. For those dealing with depression, every day is a struggle to persevere and try to regain a sense of normalcy.

A new therapy for treatment-resistant depression was approved by the Food and Drug Administration (FDA) earlier this week, one that could help those that have been unable to find relief elsewhere. The unexpected source of the therapy is esketamine. If the name of this drug sounds familiar, it is because the name is based on, and molecularly similar to, the street drug named ketamine. While originally synthesized in the 1960’s as an anesthetic and first used widely in the Vietnam War, ketamine is now known as a party drug, providing the user with mild hallucinations and a sense of euphoria. Due to its dangerous side-effects and potential for abuse, ketamine was placed on the Schedule III of the United States Controlled Substance Act in August of 1999.

In the early 1990’s, researchers at Yale University first recognized the potential for ketamine to treat the symptoms of depression. Since then, scientists sought to confirm the viability of ketamine as a treatment option for individuals who did not experience relief from other treatment methods. A 2012 study out of Baylor College of Medicine proved just that: 85% of patients with severe depression reported the treatment to be effective. Unlike selective serotonin reuptake inhibitors (SSRIs), which are most commonly prescribed to treat depression and can take weeks to build in a patient’s system before becoming effective, ketamine can provide nearly immediate relief with its full effect being felt in as little as two days.

With the science firmly in place, the next hurdle advocates of ketamine faced was of perception—in the eyes of the FDA and the public alike. Radical clinics began to emerge across the country to provide patients suffering from treatment-resistant depression with a safe, heavily-monitored environment to undergo care. Because ketamine had yet to be recognized as a potential aid for depression by the FDA, clinic physicians would often have to prescribe the drug under the guise of using it as an anesthetic. The “don’t ask, don’t tell” approach to a new treatment for a severe mental disorder created some inevitable quandaries for both doctors and patients, who would be unable to receive insurance coverage for a non-FDA approved treatment program.

While the medical community was well aware of the healing potential of ketamine, pharmaceutical companies were reluctant to make the investment. The average price-tag of a clinical trial for the FDA is $19m. There is certainly a market for the drug with countless Americans suffering from depression. The issue holding pharmaceutical companies back is related to patent law. In order to receive a patent, the proposed invention must be novel—and considering that ketamine has been around for nearly sixty years, that would be an impossible claim to make. Without patent protection, the multi-million dollar investment is bad economics for big pharma, even if the trials could provide relief for millions of Americans.

So why did Janssen Pharmaceuticals, the developer of a treatment method for depression based on ketamine, make the investment and receive FDA approval for its new drug Sprovato? The answer is because Sprovato is esketamine, a sufficiently different molecule from ketamine to be patentable. Certain molecules can be left-handed and have right-handed doppelgangers. While it is beyond the scope of this blog piece (and the ability of its author) to explain the difference between the two, esketamine is the left-handed version of ketamine’s right hand. The deviation between the molecules is a significant enough difference to pass the novelty requirement necessitated by the U.S. Patent and Trademark Office (USPTO). While there is some debate as to whether esketamine is as effective as its counterpart, esketamine passed the FDA’s clinical trials and, for the most part, has been received as a viable alternative to ketamine treatment. This development could help legitimize the countless ketamine clinics that have emerged across the United States over the last few years, yielding a promising new alternative for those struggling with severe depression. At the same time, the story of ketamine raises questions about the roles of several actors in the health care system, specifically pharmaceutical companies, the FDA and the USPTO, in delaying the introduction of life saving medication in order to adhere their respective financial and regulatory requirements.

Controversial Community Solar Garden Program is a Target of Minnesota’s 2019 Legislative Session

March 8, 2019
Energy Law, Environmental Law, Solar Energy

Hannah Payne, MJLST Staffer 

In 2013, Minnesota’s legislature opened the way for certain solar projects with the passage of the Community Solar Garden Program. The program requires Xcel Energy to purchase the energy created by Community Solar Gardens (“CSGs”) that are under a certain generation capacity. CSGs represent a middle ground between residential rooftop solar and large-scale, utility-owned solar. The idea is that medium-sized solar arrays are built in or near communities by developers, local residents buy subscriptions, and then the utility buys the energy from the array and credits the resident subscribers’ accounts. Solar developers sell subscriptions by highlighting the chance to save money and help the environment.

CSGs have been controversial since the inception of the program. Along with the significant growth of CSGs in Minnesota have come concerns about the sales practices of developers, who have been accused of misrepresenting the certainty of profit or stage of project development. The Attorney General warns consumers to “make sure they fully understand a subscription agreement and carefully consider whether they are willing to commit to its terms.” Opponents also decry that the majority of the capacity – 90% – of CSGs is purchased by commercial and other non-residential customers, undercutting the idealistic image of CSGs bringing renewable energy tangibly closer to communities. However, CSG advocates point out that the vast number of subscribers – 92% – are actually residential; they just use less energy than commercial customers.

At the heart of the controversy is the price issue. Opponents of the CSG program, including Xcel, say that it is far cheaper to produce solar energy in a large-scale setting. Xcel recently committed to going 100% carbon-free by 2050, and is likely focused on building renewable capacity efficiently. On the other side, proponents claim that Xcel’s lack of tolerance for competition has resulted in the undervaluation of CSGs because the social benefits and avoided costs have been ignored.

In any case, the CSG program looks poised to undergo change this year; several CSG bills have been introduced in the legislature. Senator Mike Goggin, a nuclear plant manager at Xcel, has proposed total repeal of the CSG program. Another bill would require Public Utilities Commission approval of CSG projects and cap the amount of capacity that may be built within the program annually at 25 Megawatts (there is currently no limit). Other proposals aim to improve developer sales practices, one listing detailed disclosures to be required in promotional materials, another calling for the state’s Clean Energy Resource Team partnership to develop a “disclosure checklist” for developers. Yet another bill would fund a study of “economic benefits to farmers” to investigate if the CSG program may be tweaked to be more farmer-friendly.

Minnesota is a national leader when it comes to CSGs; many will be watching to see how the legislation develops. As Xcel and others get more serious about renewable energy, conversations and controversies around renewables can only be expected to increase. Watching a debate like this unfold is a great way to keep a finger on the pulse of the energy world in this exciting time.

Practical Results of Enforcing the GDPR

March 8, 2019
EU Law, International Law, Privacy

Sooji Lee, MJLST Staffer

After the enforcement of the European Union’s(“EU”) General Data Protection Regulation (“GDPR”), Facebook was sued by one of its shareholders, Fern Helms, because its share price fell more than “20 percent” in July 27, 2018. This fall in stock price occurred because the investors were afraid of the GDPR’s potential negative impact on the company. This case surprised many people around the world and showed us how GDPR is sensational regulation that could result in lawsuits involving tremendous amounts of money. This post will articulate what has occurred after enforcement of this gigantic world-wide impacting regulation.

Under GDPR, regulated entities (data controllers and data processors) must obtain prior “consent” from their users when they request customers’ personal data. Each member country must establish Data Protection Authority (“DPA”) to comply with the GDPR. This regulation has a broad applicable range, from EU corporations to non-EU corporations that deal with EU citizens’ personal data. Therefore, after the announcement of this regulation, many United States based global technology corporations which conduct some of their business in European countries, such as Google and Facebook, commenced processes to comply with the GDPR. For example, Facebook launched its own website which explains its effort to comply with GDPR.

Surprisingly, however, despite the large-scale preparation, Google and Facebook were sued for breach of the GDPR. According to a report authored by IAPP, thousands of claims were filed within one month the GDPR’s enforcement date, May 25, 2018. This fact implies that it is difficult to abide by GDPR for current internet-based service companies. Additionally, some companies that are not big enough to prepare to comply with the GDPR, such as the Chicago Tribune and the LA Times, temporarily blocked EU users from its website and some decided to terminate its service in the EU.

One interesting fact is that no one has been fined under GDPR yet. A spokesperson for the United Kingdom’s Information Commissioner’s Office commented “we are dealing with the first GDPR cases but it’s too early to speculate about fines or processing bans at this stage.” Experts expect that calculating fines and processing bans could take another six months. These experts foresee that once a decision is rendered, it could set a standard for future cases which may be difficult to change.

The GDPR, a new world-wide impacting regulation, just started its journey toward proper consumer data protection. It seems many of the issues involved with the GDPR are yet to be settled. For now, no expert can make an accurate prediction. Some side-effects seem inevitable. So, it is time to assess the results of the regulation, and keep trying to make careful amendments, such as expanding or restricting the scope of its applicable entities, to adjust for arising problems.

Seasteading

March 1, 2019
Environmental Law, Maritime Law

Will Dooling, MJLST Staffer

This February, students at the University of Minnesota fought record snowfalls and low temperatures. A lot of us are dreaming of running away to a tropical island somewhere, or buying one and starting our own country. Today, we explore “seasteading,” the practice of founding a sovereign nation on the high seas, usually on a floating platform, or a remote private island.

Sovereign nations have already claimed every large island, and every part of the ocean even remotely near shore. As such, seasteading requires a would-be nation-builder to either construct a new island on a deep ocean seamount or build a floating platform from scratch. Both are remarkably challenging and costly feats of engineering. Even very generous estimates put the cost of a freestanding deep-sea platform capable of supporting a few residents at $50 million. The other challenge, of course, is supplying the community’s inhabitants with food, water, and electricity. While a seasteader could try imaginative solutions ranging from self-sufficient algae farms to enormous solar-powered desalination systems, the practical startup cost of such an operation is utterly enormous.

The attraction is obvious, though, largely thanks to the persistent myth that once safely in international waters on a floating platform or a private island, no laws will apply. It is certainly true that Article 2 of the 1958 UN Convention on the High Seas prohibits any signatory from claiming sovereignty over the high seas, and Article 57 of the UN Convention on the Laws of the Sea limits the exclusive economic zone of any nation (the region of the sea over which that nation has total sovereign control) to no more than “200 nautical miles from the baselines from which the breadth of the territorial sea is measured.” However, these limitations have never seriously prevented the United States, for example, from carrying out law enforcement activities to prevent “acts done outside a geographic jurisdiction, but which produce detrimental effects within it[.]” United States v. Smith, 680 F.2d 255, 258 (1st Cir. 1982). This means that the most tempting uses of a seastead—an offshore casino, a drug den, or a tax haven—are unworkable. One of the only law review articles to seriously examine seasteading puts it bluntly: “Given the United States’ penchant for exercising jurisdiction thousands of miles from its coastlines, not even the territorial seas of other nations may be sufficient to protect a seastead from American jurisdiction.”

A few innovative souls have tried semi-serious attempts to start a sovereign nation on the high seas, but none have quite succeeded. In the 1970s, real estate tycoon Michael Oliver spent millions of dollars attempting to found a sovereign state on a cluster of reefs in the South Pacific, about 250 miles from the island nation of Tonga. He dubbed his project the “Republic of Minerva.” Oliver created his own currency, flag, and declaration of independence from Tonga, but his project ultimately failed when Tongan king Taufa’ahau Tupou, and a construction crew, arrived and dissembled Oliver’s early construction work on the reefs. Oliver then abandoned the project.

Similarly, from 1976 to 2010, pirate radio broadcaster Paddy Roy Bates made periodic attempts to claim a World War II era anti-aircraft platform situated in the North Sea as a sovereign nation. Sealand, like the Republic of Minerva, has its own currency, constitution, and even its own national anthem. Sealand also sells titles of nobility. British pop star Ed Sheeran, for example, is a Baron of Sealand. Unlike the Republic of Minerva, Sealand is still going strong, and purportedly celebrated its 50th anniversary in 2017, but only two people live there permanently.

Currently, the largest promoter of seasteading is the libertarian-aligned Seasteading institute, an organization that hopes to build utopian communities of artificial islands set in international waters, though critics charge that the project is largely an attempt to bypass regulation (and taxation) that its members find inconvenient. In 2017, the government of French Polynesia briefly flirted with the idea of allowing the Seasteading Institute to establish an experimental economic seazone in their territorial waters, though the deal ultimately seems to have fallen through.

While no one has successfully gotten a self-sufficient seasteading community afloat, the dream is completely understandable. Once we get better at deep-water construction and remote power generation, it may actually be possible. Until then, it remains a dream, though one that is relatable and understandable in the depths of a Minnesota winter, at least until Tonga invades.

Antitrust Violations Against Apple: Is the Tech Giant Operating an Illegal Monopoly?

March 1, 2019
Antitrust

Joe Hallman, MJLST Staffer

Apple Inc. is again under legal fire as allegations of antitrust violations against the tech giant have made it to the Supreme Court. The Court recently heard oral arguments in November of 2018 in Apple Inc. v. Pepper. Plaintiffs in the case are a class of iPhone users, and allege that Apple’s App Store, the only forum for iPhone users to download apps, creates an illegal monopoly. Apple collects 30% of all sales of apps made via its App Store; Plaintiffs argue that this is an overcharge made possible only by the unlawful monopoly. Apple claims in response that its App Store is not an illegal monopoly and that, even if it was, Apple is not a seller of goods but simply facilitates a marketplace.

The question before the Supreme Court is not whether Apple actually did violate antitrust laws, but whether iPhone users would even be able to recover damages from Apple if it did. The Court seeks to answer this question in light of Supreme Court precedent stemming from a 1977 decision in Illinois Brick Co. v. Illinois, in which the Court held that only direct, rather than indirect, purchasers can recover damages for antitrust violations. Here, plaintiffs argue that they directly purchase apps from Apple through its App Store, whereas Apple maintains that iPhone users are actually purchasing apps from the app developers. If the Court were to side with Apple, iPhone users would not be able to recover damages from them. Only app developers, as purchasers of the distribution service the App Store provides, could sue Apple for antitrust violations.

The Supreme Court is expected to decide the case by June of 2019. If the Court decides in favor of the plaintiffs, holding that iPhone users can recover damages from Apple, the case would be remanded to a lower court to determine whether antitrust violations actually occurred. In the future, if Apple is found to be operating an illegal monopoly it could have enormous implications. Large amounts of money are potentially at stake. It is estimated that Apple brought in $11 billion in revenue from its App Store in 2017 alone and antitrust laws permit plaintiffs to potentially recover triple damages. Beyond the dollars at stake, a decision that Apple is operating an illegal monopoly could completely change the industry. A decision of that nature could give rise to many different marketplaces that make apps available for iPhone users to download potentially lowering the price for the end users. The first step, however, is the decision to be handed down by the Supreme Court in Apple Inc. v. Pepper to determine whether iPhone users are able to sue Apple for damages.

The First Amendment and Trademarks: Are Offensive Trademarks Registrable?

February 25, 2019
First Amendment, Intellectual Property, Trademark Law

Kelly Brandenburg, MJLST Staffer 

The Lanham Act, which is the federal statute that governs trademarks, had a disparagement clause, that prohibited the registration of a trademark “which may disparage . . . persons, living or dead, institutions, beliefs, or national symbols, or bring them into contempt, or disrepute.” This provision has been the focal issue in several cases over the years, but was finally brought up to the Supreme Court of the United States (“SCOTUS”) which decided that the clause was unconstitutional.. In that case, Matal v. Tam, an Asian-American dance-rock band with the name “The Slants” was originally denied trademark protection on their name because “slant” is a derogatory term for people of Asian descent. In the end, the Court found the disparagement clause violated the free speech clause of the First Amendment. The Court said the clause violated the basic principle of the First Amendment that “speech may not be banned on the ground that it expresses ideas that offend.”

This decision had a significant impact on a well-known case involving the Washington Redskins. The team had six trademarks that were cancelled by the Trademark Office in 2014, but after the Matal decision, the U.S. Court of Appeals for the Fourth Circuit vacated that prior decision since the disparagement clause was the basis for the Native American’s argument to revoke the Redskin registrations.

Currently, there is a case awaiting a Supreme Court hearing that discusses a closely related topic. In re Brunetti involves a trademark for the word “Fuct,” which is the name of a clothing brand. The Trademark Trial and Appeal Board found the word to be “vulgar,” which violates the immoral or scandalous provision of the same statute that was at issue in Matal. The case was appealed and the Federal Circuit upheld the rejection of the registration. The ruling in Matal was discussed as an argument for the immoral or scandalous clause being unconstitutional, but the Court decided the case without addressing the constitutionality of the clause; instead, it determined that the word “impermissibly discriminates based on content in violation of the First Amendment,” and is therefore not registerable. However, SCOTUS granted certiorari in the case and depending on how the Court defines the word, it will potentially have to address the constitutionality of the immoral or scandalous provision. An argument was made at the Federal Circuit that the immoral or scandalous clause would be constitutional because, unlike the disparagement clause, this clause is “viewpoint neutral.” This argument was not addressed by the Federal Circuit, but could potentially be addressed in the upcoming SCOTUS hearing. If so, will  SCOTUS find enough of a difference between the disparagement clause and the immoral or scandalous clause to consider it constitutional, or will the same free speech issues be present? The oral argument is scheduled for April 15, 2019, so stay tuned!

The Environmental Costs of Amazon

February 25, 2019
Climate Change, Environment, New Technology

Christina Petsoulis, MJLST Staffer 

Amazon. One of the 21st century’s most novel inventions. Amazon now dominates e-commerce, with 43% of money spent online coming from Amazon sales. The online retail giant has, without a doubt, changed the way society operates – in some ways, for the better, while in others, for the worse.

Amazon’s carbon footprint is nothing short of concerning, especially with its continued expansion of Prime services. Expedited shipping means more cars and trucks on the road for delivery services, and increased waste from packages that are not as consolidated as they could be. Amazon packaging demands billions of boxes each year, with over 5 billion Amazon Prime packages alone sent worldwide in 2017. In fact, 64% of American households have Amazon Prime, and traditional brick-and-mortar retailers are closing down in every market as a result of the shift toward online retail shopping.

Some experts argue that having individual consumers drive to, and shop at, traditional brick-and-mortar retailers is more inefficient than consolidating packages for delivery. I find this argument unpersuasive, as consumers tend to make small purchases each time they shop online, requiring multiple shipments per week per consumer. Moreover, while online retail continues to gain dominance, traditional retail still exists and has shipping and packaging demands of its own. This situation, in essence, doubles consumer ‘demands.’

But most of Amazon packaging is recyclable, so we’re good, right? Not exactly. First, just 34% of solid waste is recycled (attributable to both consumer behavior and access to municipal recycling services). 80% of solid waste is recyclable with just 28% of it actually being recycled. Second, the vast majority of U.S. recyclables are sent to China for processing, which is problematic because China has announced that it will no longer import foreign garbage. In fact, China has banned importation of particular paper and plastic products, leaving the U.S. to deal with its own trash. With increased waste management demand and decreased capacity to deal with it, big questions remain as to how federal, state and local government will fare the storm.

Is Amazon liable for the vast quantities of trash it introduces into the market? Will Amazon be asked to alter business behavior, such as cut down on its packaging materials or enforce package consolidation policies? These types of requirements counter Amazon’s business interests, as the dominant draw of Amazon is individualized, convenient, fast shipping. Amazon’s model facilitates individual gain (i.e. $7.99 water bottle shipped day-of-order for free) at the expense of our environment’s health (i.e. one over-sized cardboard box ending up in a landfill). The epitome of a negative externality. It seems unlikely that any sort of regulation on packaging, shipping, and handling would stand a chance in light of consumer gravitation toward online shopping.

Government has tried to regulate Amazon, but not necessarily for environmental reasons. For example, the Federal Trade Commission has probed Amazon’s pricing practices as it expands its markets beyond e-commerce, threatening companies such as Netflix and Apple with its video services.

Surely, Amazon is not the only actor in the issue of environmental costs associated with e-commerce. But with 43% of online purchases coming from Amazon, it’s hard not to point fingers at a company so heavily dominating the marketplace.

Google Fined for GDPR Non-Compliance, Consumers May Not Like the Price

February 19, 2019
Business Law, Data, Ethics, Privacy, Social Media

Julia Lisi, MJLST Staffer

On January 14th, 2019, France’s Data Protection Authority (“DPA”) fined Google 50 million euros in one of the first enforcement actions taken under the EU’s General Data Protection Regulation (“GDPR”). The GDPR, which took effect in May of 2018, sent many U.S. companies scrambling in attempts to update their privacy policies. You, as a consumer, probably had to re-accept updated privacy policies from your social media accounts, phones, and many other data-based products. Google’s fine makes it the first U.S. tech giant to face GDPR enforcement. While a 50 million euro (roughly 57 million dollars) fine may sound hefty, it is actually relatively small compared to maximum fine allowed under the GDPR, which, for Google, would be roughly five billion dollars.

The French fine clarifies a small portion of the uncertainty surrounding GDPR enforcement. In particular, the French DPA rejected Google’s methods for getting consumers to consent to its  Privacy Policy and Terms of Service. The French DPA took issue with the (1) numerous steps users faced before they could opt out of Google’s data collection, (2) the pre-checked box indicating users’ consent, and (3) the inability of users to consent to individual data processes, instead requiring whole cloth acceptance of both Google’s Privacy Policy and Terms of Service.

The three practices rejected by the French DPA are commonplace in the lives of many consumers. Imagine turning on your new phone for the first time and scrolling through seemingly endless provisions detailing exactly how your daily phone use is tracked and processed by both the phone manufacturer and your cell provider. Imagine if you had to then scroll through the same thing for each major app on your phone. You would have much more control over your digital footprint, but would you spend hours reading each provision of the numerous privacy policies?

Google’s fine could mark the beginning of sweeping changes to the data privacy landscape. What once took a matter of seconds—e.g., checking one box consenting to Terms of Service—could now take hours. If Google’s fine sets a precedent, consumers could face another wave of re-consenting to data use policies, as other companies fall in line with the GDPR’s standards. While data privacy advocates may applaud the fine as the dawn of a new day, it is unclear how the average consumer will react when faced with an in-depth consent process.

Supervised Injection Facilities: A Step in the Right Direction to Mitigate the Opioid Crisis or a Violation of Federal Law?

February 19, 2019
Bioethics, Drug Policy, Pharmaceuticals

Jessica Swanson, MJLST Staffer

Plans for the nation’s first supervised injection facility hit a snag earlier this month when Philadelphia’s top prosecutor filed a federal complaint to keep it from opening its doors. Supervised injection facilities (SIFs) are legally sanctioned facilities that allow people to consume pre-obtained drugs under the supervision of trained staff and are designed to reduce the number of lives that would otherwise be lost to overdoses and provide a bridge to treatment. SIF staff members do not directly assist in consumption or handle any drugs brought in by clients, but are employed to provide sterile injection supplies, free testing, free distribution of the opioid overdose reversal medication, monitoring services for overdoses, and answers to questions about safe injection practices. SIF staff also offer general medical advice and referrals to drug treatment and other social support programs. There are approximately 120 SIFs currently operating in twelve countries around the world, but none in the U.S. However, a handful of U.S. cities, including New York, Seattle, Denver, San Francisco, and Delaware, have inched toward making SIFs a reality as each struggles to combat the increasing amount of drug-related deaths due to the opioid crisis. Philadelphia is by far the closest to becoming home to the nation’s first SIF, incorporated as “Safehouse.” However, on February 5th, the U.S. Attorney for the Eastern District of Pennsylvania, William McSwain, filed a lawsuit aimed at blocking Safehouse from opening its doors.

The civil lawsuit, which is jointly being pursued by Pennsylvania Attorney General Josh Shapiro and the Department of Justice in Washington asks a judge to declare such a facility illegal under federal law. Instead of waiting for Safehouse to open and then conducting arrests and a prosecution, McSwain is asking U.S. District Court Judge, Gerald McHugh, to rule on the legality of SIF plans in general. According to the complaint, a supervised injection site would violate a section of the 1986 Controlled Substances Act (CSA). The relevant section, also known as the “crack house statute,” was enacted during the height of the crack epidemic and was primarily used to shut down crack houses. The CSA makes it a felony punishable by up to 20 years in prison to knowingly open or maintain any place, regardless of compensation, for the purpose of using controlled substances. McSwain argues that Safehouse seeks to disregard the law and override Congress’ regulatory scheme by establishing, managing, and controlling sites in Philadelphia that will allow individuals to engage in the illicit use of controlled substances. Ronda Goldfein, vice president and attorney for Safehouse, argues CSA was not intended to apply to a medical facility focused on saving lives and moving people who are addicted to opioids into treatment. She argues the provision of the CSA in question is widely known to prosecute situations that involve crimes such as drug sales out of a car dealership or music festivals that allowed illegal drugs to flow freely. Safehouse, on the other hand, is a facility with good-faith efforts to improve public health.

Although other states like Pennsylvania are well-intentioned in opening SIFs, it is likely that the Controlled Substances Act is broad enough to encompass SIFs and thus bar them from operating. If Philadelphia or others want to open this type of site, they might want to steer their efforts towards changing the law. Overall, other cities that have expressed their intention of opening a SIF will be watching this case closely as it serves as an important test to determine the legality of SIFs.

A Data Privacy Snapshot: Big Changes, Uncertain Future

February 19, 2019
Business Law, Cyber Security, Data, Internet

Holm Belsheim, MJLST Staffer

When Minnesota Senator Amy Klobuchar announced her candidacy for the Presidency, she stressed the need for new and improved digital data regulation in the United States. It is perhaps telling that Klobuchar, no stranger to internet legislation, labelled data privacy and net neutrality as cornerstones of her campaign. While data bills have been frequently proposed in Washington, D.C., few members of Congress have been as consistently engaged in this area as Klobuchar. Beyond expressing her longtime commitment to the idea, the announcement may also be a savvy method to tap into recent sentiments. Over the past several years citizens have experienced increasingly intrusive breaches of their information. Target, Experian and other major breaches exposed the information of hundreds of millions of people, including a shocking 773 million records in a recent report. See if you were among them. (Disclaimer: neither I nor MJLST are affiliated with these sites, nor can we guarantee accuracy.)

Data privacy has been big news in recent years. Internationally, Brazil, India and China are have recently put forth new legislation, but the big story was the European Union’s General Data Privacy Regulation, or GDPR, which began enforcement last year. This massive regulatory scheme codifies the European presumption that an individual’s data is not available for business purposes without the individual’s explicit consent, and even then only in certain circumstances. While the scheme has been criticized as both vague and overly broad, one crystal clear element is the seriousness of its enforcement capabilities. Facebook and Google each received large fines soon after the GDPR’s official commencement, and other companies have partially withdrawn from the EU in the face of compliance requirements. No clear challenge has emerged, and it looks like the GDPR is here to stay.

Domestically, the United States has nothing like the GDPR. The existing patchwork of federal and state laws leave much to be desired. Members of Congress propose new laws regularly, most of which then die in committee or are shelved. California has perhaps taken the boldest step in recent years, with its expansive California Consumer Protection Act (CCPA) scheduled to begin enforcement in 2020. While different from the GDPR, the CCPA similarly proposes heightened standards for companies to comply with, more remedies and transparency for consumers, and specific enforcement regimes to ensure requirements are met.

The consumer-friendly CCPA has drawn enormous scrutiny and criticism. While evincing modest support, or perhaps just lip service, tech titans like Facebook and Google are none too pleased with the Act’s potential infringement upon their access to Americans’ data. Since 2018, affected companies have lobbied Washington, D.C. for expansive and modernized federal data privacy laws. One common, though less publicized, element in these proposals is an explicit federal preemption provision, which would nullify the CCPA and other state privacy policies. While nothing has yet emerged, this issue isn’t going anywhere soon.

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