Regulatory

Treating Depression With Ketamine? How the Investment Was Made

March 15, 2019
Administrative Law, Biotechnology, Food and Drug Law, Health, Regulatory

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.

Health Supplements: The “Wild West” of FDA Regulations

February 10, 2019
Administrative Law, Food and Drug Law, Regulatory

Gabe Branco, MJLST Staffer

At some point, we all have taken a multivitamin and/or some type of dietary supplement. They are hard to miss in most stores such as Target or Wal-Mart. The bright colored packaging and unfulfilling promises of “losing weight quickly” without dieting or “building muscle” without working out catches everybody’s attention. Most people assume that these products, ironically labeled “health” or “dietary” supplements, must be safe to ingest due to placing them in the same category as a “drug,” or because they deem the supplement to be “natural.” However, the reason people are mistaken is because the Food and Drug Administration (“FDA”) chooses to differentiate “health” products from “drugs.”

Under the FDA’s current regulatory scheme, “health” supplements are treated more like special foods than drugs. Drugs are considered unsafe until proven safe through clinical trials. These trials must be done on all drugs, even those that are sold without a required prescription. The trials must show that the drug is both safe and effective for the specified use. Once the drug is approved, manufacturers are subject to carefully monitored conditions and packaging requirements. The packaging requirement includes conditions the drug has been proven to treat, known side effects, contraindications, and unsafe interactions with other drugs. After the drug has been manufactured and released to the public for consumption, the FDA follows up on any adverse effects consumers and their doctors report, along with any adverse effects reported by the manufacturer.

“Dietary” supplements, on the other hand, are seen as safe until proven unsafe, a stark contrast to their drug counterpart. The Dietary Supplement Health and Education Act (DSHEA) defines “dietary” supplements as a category of food. As such, “dietary” supplements do not undergo the rigorous pre-manufacturing and post-manufacturing approval and monitoring process that drugs do. DSHEA prohibits supplements from containing anything that may have “a significant or unreasonable risk of illness or injury” when the supplement is used as directed on the label, or with regular use if there are no directions. While the regulation makes clear these supplements should not significantly or unreasonably expose the public to increased risk of harm, DSHEA fails to enforce the regulation with any preventative measures.

DSHEA effectively allows manufacturers to print any statement they wish on “dietary” supplement labels, so long as it is followed by the phrase “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” This practice is troublesome because the statement may suggest or claim outright that the “dietary” supplement treats symptoms or results in an outlandish outcome if taken. Even with the FDA warning, consumers would have little to no reason to assume that supplements placed on shelves everywhere could contain none of the listed ingredients or unknown ingredients that can cause adverse health effects.

The FDA has the authority to stop any production of “dietary” supplement if it is shown there is an increased risk of harm to the public. However, this only occurs after the release of the supplement and subsequent adverse effects impact consumers. Due to the lack of pre-manufacturing testing requirements, many “dietary” supplements contain germs, pesticides, or toxic heavy metals that may adversely impact consumers. In addition, many “dietary” supplements either do not contain what is listed on the label, contain more or less of what is listed on the label, or even contain ingredients not listed on the label. This issue could also stem from parties other than the manufacturers and sellers. Without any regulations pre-manufacturing, many suppliers of ingredients may mix or substitute the ingredients sold to manufacturers with less expensive or tainted filler ingredients.

These issues become problematic when an ingredient the FDA would deem a “drug” finds its way into a “dietary supplement.” Many male enhancers or muscle building “dietary” supplements have been found to contain substances much like Viagra or Cialis, which are regulated as “drugs.” In addition, certain weight loss supplements have been found to contain sibutraimine, which has been banned in the United States. All of these supplements were recalled by the FDA in a reactionary manner. However, in most instances a “dietary” supplement may contain a drug that has little to no known effects. Having little to no known effects makes it more difficult to detect if a “dietary” supplement indeed contains a drug, and if it then must undergo the more rigorous FDA drug requirements. By providing manufacturers and sellers a pathway to produce categorical “drugs” and distribute them to the public without undergoing the rigorous FDA drug testing processes, DSHEA potentially does more deregulation than regulation.

FDA regulations concerning “dietary” supplements should be as stringent as regulations governing drugs. The simplest solution would be to implement the same pre-manufacturing and post-manufacturing procedures that are required of “drug” manufacturers into the “dietary” supplement realm. Doing so would fulfill DSHEA’s requirement that the “dietary” supplements do not cause a significant or unreasonable increase in risk of injury or illness. Additionally, this would allow the FDA to regulate “drugs” to its fullest potential.

Impact of China’s Generics Push on Innovator Drug Companies

November 12, 2018
Food and Drug Law, Intellectual Property, Regulatory

Sherrie Holdman, MJLST Staffer

With a population of 1.42 billion, China presents a large market for both innovator manufacturer and generic drug companies. Currently, about 95% of marketed drugs are sold by generics. However, many patients in China opt to use more expensive, imported, brand-name drugs. In an effort to address this problem, China’s State Council has announced its “Opinions Concerning Reforms of Policies to Improve the Supply and Utilization of Generics” to encourage the people of China to use generic drugs early this year. As a regulatory document, the Opinion shed light on the future direction of China’s generic market.

The Opinion identifies three important suggestions to guide implementation. The first suggestion is to promote research and development of generic drugs in China. The Opinion proposes a drug list to be compiled that identifies drugs for which generic counterparts don’t exist yet. The Opinion also encourages the government to develop key technologies in manufacturing generics. The second suggestion aims to improve the quality and efficacy of generic drugs. Generics will only be approved if their quality and efficacy are equivalent to the original drugs. To facilitate this goal, the State Council proposes speeding up the conformity assessment of quality and efficacy of generic drugs and improving the quality management of generic drugs. The third suggestion is to provide policy incentives for generics development, including implementation of a tax policy for generic manufacturers. Under this policy, a generic manufacturer, once designated as a “high technology enterprise,” will have a preferential tax rate of 15%, compared to the 25% rate for other companies. In order to be a “high technology enterprise,” the generic manufacturer will need to meet certain qualifications. Meanwhile, the Opinion encourages patentees to voluntarily grant compulsory licenses to Chinese generic manufacturers when there is “a serious threat to the public health.” However, despite its long existence in Chinese patent law and regulation, the compulsory licenses are historically rare in practice, partly because of the difficulty in defining what constitutes a “serious threat to the public health.”

In order to balance the interests of innovator and generic drug companies, the Opinion provides recommendations for strengthening the enforcement of intellectual property rights. For example, the Opinion proposes establishing an “early warning patent system” to prevent generic manufacturers from infringing on valid patents and thus mitigating the risk of infringement. Moreover, the State Council proposed to enhance accessibility of innovative drugs, especially imported oncology drugs, by applying no tariffs on imported new drugs. A five-year patent extension for new drugs was also proposed to enhance the intellectual property protection of innovator drugs.

Following the announcements promulgated in the Opinion, on April 25, 2018, China Food and Drug Administration (CFDA) released its “Public Comment Draft of Pharmaceutical Data Exclusivity Implementing Rules (provisional).” The Draft proposes that “innovative new drugs” will enjoy six years of data protection and “innovative therapeutic biologics” will enjoy 12 years of data protection. By proposing data protection for new drugs, China encourages multinational corporations to include China in international multicenter clinical trials and to concurrently apply for market introduction in China. Even if the new drug is introduced to China at a later time, the drug will still be entitled to a data protection period (e.g., from one to five years). The public comment period for the Draft was closed on May 31, 2018 and the final rule is expected soon.

Facing China’s generics push, innovator drug makers can strengthen their IP strategy in numerous ways. For example, companies should disclose information about the patents in the drug list in a timely manner, making the public and government aware of the patents. Further, companies should also establish a multi-directional scheme for IP rights protection including not only patent, but also knowhow, trade secret, design, trademark and copyright.

Tesla: Can the Electric Car Company Overcome Its CEO’s Erratic (and Sometimes Illegal) Behavior?

November 12, 2018
Business Law, Ethics, Regulatory, Securities Law

Joe Hallman, MJLST Staffer

Elon Musk, the ingenious and at times controversial CEO of Tesla, Inc., has been a fixture in the national news cycle of late with many questioning his erratic behavior. Musk has garnered negative attention recently for incidents ranging from publicly smoking marijuana to hurling wild accusations against critics on Twitter. However, Musk’s most significant faux pas in recent months was likely a tweet that resulted in him being charged with securities fraud by the Securities and Exchange Commission (“SEC”).

On August 7, 2018, Musk tweeted “Am considering taking Tesla private at $420. Funding secured.” The SEC sued Musk in federal court on September 27 for misleading investors with his tweet. Musk settled with the SEC two days later on September 29. The terms of the settlement required Musk to pay a $20 million personal fine and step down as chairman for three years, although he was allowed to remain CEO of the company. Although not charged with fraud, Tesla also settled with the SEC for $20 million.

Tesla’s stock price plummeted shortly after the SEC’s lawsuit was filed. Tesla shares were trading at about $305 prior to the lawsuit and on September 28, the day after the SEC filed suit, Tesla’s shares dropped to about $269. However, after that initial dip Tesla’s stock rebounded, eventually closing at $341.06 on November 6.

Many have questioned Tesla’s viability as a company over the years and it has been a common short sell among investors. However, considering Musk’s curious recent behavior, the stock price has been resilient. Meanwhile, on October 24, Tesla released its 2018 third-quarter earnings report showing surprise profits and positive cash flow. The earnings report is good news for shareholders who eagerly wait to see if Musk’s electric car company can eventually turn the corner and achieve a significantly higher market cap as Musk has promised.

Although Tesla seems to have been largely unaffected by the SEC’s lawsuit and other strange behavior by Musk, other top executives of publicly traded companies will likely take notice and learn from Tesla’s tumultuous past few months. Going forward, I would expect CEO’s of high-profile companies like Tesla to be careful about Twitter usage and seek to avoid negative attention in the press.

FDA’s Nutrition Innovation Strategy: The Right to Remain Silent on Added Sugars

November 5, 2018
Administrative Law, Food and Drug Law, Regulatory

Christina Petsoulis, MJLST Staffer

As of 2017, obesity rates in the United States reached 38.9%. It is without a doubt that poor diet is a major contributing factor to obesity prevalence. More specifically, diets consisting of convenience foods containing high amounts of added sugar serve as significant exposures leading to obesity and other comorbidities. A recent study reported that sugar was added to 66% of packaged foods.

While the sugar industry is quick to blame lack of physical activity for America’s obesity rates, research is clear that diets high in refined sugar increase the risk of obesity, cardiovascular disease, diabetes, fatty liver disease, cognitive decline and some cancers.

Though the linkages between food and obesity have been well established in scientific literature for some time, it is not until now that the Food and Drug Administration (FDA) has seriously recognized the importance of diet quality in chronic disease prevention.

On March 29, 2018, FDA commissioner, Dr. Scott Gotlieb, announced the Nutrition Innovation Strategy (NIS). Some of the key elements highlighted in the NIS include: modernizing claims, modernizing ingredient labels, modernizing standards of identity, implementing the nutrition facts label and menu labeling, and reducing sodium. The agency stated that it would be “committed to finding new ways to reduce the burden of chronic disease through improved nutrition.”

Gotlieb’s press release introducing the initiative seems to take a different perspective despite the agency’s intended goal.

In Gotlieb’s statement, he started by explaining the critical importance of a healthy diet in human health. He first introduced the importance of informed consumer choice as it relates to transparent labeling, then dove into the issue of “standards of identity.” Using milk as a key example, he explained that plant-based alternatives to cow’s milk, such as soy and almond-based beverages, labeled as “milk” create major public health concerns, including cases of kwashiorkor (protein deficiency disorder), and rickets (vitamin D deficiency disorder). He then went on to cite a case where a child was diagnosed with rickets as a result of parents assuming a soy-based beverage they fed their child contained the same nutritional qualities as cow’s milk. While the issue of standards of identity is relevant to public health nutrition in the context of protein deficiency and other forms of malnutrition, these issues have little relevance to obesity, or any other chronic disease for that matter.

It is surprising to see that Gotlieb’s press release does not highlight any of the important factors contributing to obesity in light of the initiative’s supposed goals. The worry, of course, is that the FDA is tip-toeing around food-industry players and, namely, the sugar industry in efforts to avoid conflict. The sugar industry is known for its aggressive efforts to shift blame for obesity on poor diet to lack of physical activity and poor consumer choice. For example, it was recently discovered that the sugar industry paid Harvard scientists to produce favorable results in their nutrition research on sugar’s role in heart disease.

While FDA has addressed the issue of sugar content through “added sugars” labeling requirements finalized in May 2016, little has been done to address sugar content in packaged foods. Serious efforts need to be taken to reduce sugar content in foods on the market to address the obesity epidemic

“Juuling”: Gen Z’s Alleged Addiction May Mean Major Legal Problems for E-Cigarette Companies

October 6, 2018
Agriculture, Business Law, Ethics, Food and Drug Law, Health, Product Liability, Public Health, Regulatory

By: Jack Kall, Minnesota Journal of Law, Science & Technology Vol. 20 Staffer

With every new week comes new headlines regarding Gen Z and their latest craze. After years of Millennials being cast as the generation responsible for everything wrong in the world, (Business Insider’s list of 19 things Millennials are killing, including everything from homeownership, banks, football, and oil to beer, napkins, cereal, and bars of soap; NPR describing how Millennials are killing Applebee’s; Forbes claiming Millennials might kill home-cooked meals and kitchens) it seems the media has found a new culprit, Gen Z! Gen Z’s supposed addiction to e-cigarettes, specifically to the JUUL brand, is common among the headlines.

Depending on how you define the generation, Gen Z includes anyone born in the years starting with 1995–2000 and ending between 2014–25. Pew Research has yet to name or define the end date of Gen Z, but it defines the “Post-Millennial generation” as those born 1997 and later.

No matter how you define Gen Z, it includes high school students, many of whom are under the legal tobacco consumption age of 18. High schoolers have been a major reason for both the rise of e-cig popularity and for giving JUUL Labs major market share in the e-cig industry. Browse through social media pages popular within the Gen Z community and you’ll inevitably see numerous posts about “Juuling.” However, Gen Z isn’t alone in its supposed obsession with e-cigs, as Leonardo DiCaprio (a member of Gen X) has long been known to appreciate vaping (e.g., 1, 2, 3).

JUUL Labs, which launched in 2015, has been repeatedly investigated for targeting minors through its advertising and sued for targeting teens with false claims of product safety. In 2017, Consumer Reports found that teens who vape are seven times more likely to turn to regular cigarettes. Additionally, the CDC has declared e-cig use among young people a public health concern.

As further research is published, JUUL should expect be the main target of continued legal action. One current case, a nationwide class action with ten named plaintiffs aged above 13, alleges in part that JUUL’s decision to market through social media was aimed at soliciting those under the legal smoking age. Another case, filed on behalf of a high school sophomore, alleges that JUUL is commonplace among his school, including use “on the school bus, in the bathrooms, outside of school and even in class.”

JUUL Labs will hope to continue to have success while under major legal scrutiny for its marketing practices. JUUL, importantly, hopes it can continue to show growth following its impressive financial valuation (most recently raising $1.2 billion in a financing round that valued the company at over $15 billion).

The Unfair Advantage of Web Television

March 26, 2018
Data, Internet, New Technology, Regulatory, Telecommunication

Richard Yo, MJLST Staffer

Up to a certain point, ISPs like Comcast, Verizon, and AT&T enjoy healthy, mutually beneficial relationships with web content companies such as Netflix, YouTube, and Amazon. That relationship remains so even when regular internet usage moves beyond emails and webpage browsing to VoIP and video streaming. To consume data-heavy content, users seek the wider bandwidth of broadband service and ISPs are more than happy to provide it at a premium. However, once one side enters the foray of the other, the relationship becomes less tenable unless it is restructured or improved upon. This problem is worse when both sides attempt to mimic the other.

Such a tension had clearly arisen by the time Verizon v. FCC 740 F.3d 623 (D.C. Cir. 2014) was decided. The D.C. Circuit vacated, or rather clarified, the applicability of two of the three rules that constituted the FCC’s 2010 Open Internet Order. The D.C. Circuit clarified that the rule of transparency was applicable to all, but the restrictions on blocking and discrimination were applicable only to common carriers. The FCC had previously classified ISPs under Title I of the Communications Act; common carriers are classified under Title II. The 2014 decision confirmed that broadband companies, not being common carriers, could choose the internet speed of websites and web-services at their discretion so long as they were transparent. So, to say that the internet’s astounding growth and development is due to light touch regulation is disingenuous. That statement in and of itself is true. Such discriminatory and blocking behavior was not in the purview of broadband providers during the early days of the internet due to the aforementioned relationship.

Once web content began taking on the familiar forms of broadcast television, signs of throttling were evident. Netflix began original programming in 2013 and saw its streaming speeds drop dramatically that year on both Verizon and Comcast networks. In 2014, Netflix made separate peering-interconnection agreements with both companies to secure reliably fast speeds for itself. Soon, public outcry led to the FCC’s 2015 Open Internet Order reclassifying broadband internet service as a “telecommunications service” subject to Title II. ISPs were now common carriers and net neutrality was in play, at least briefly (2015-2018).

Due to the FCC’s 2018 Restoring Internet Freedom Order, much of the features of the 2015 order have been reversed. Some now fear that ISPs will again attempt to control the traffic on their networks in all sorts of insidious ways. This is a legitimate concern but not one that necessarily spans the entire spectrum of the internet.

The internet has largely gone unregulated thanks to legislation and policies meant to encourage innovation and discourse. Under this incubatory setting, numerous such advancements and developments have indeed been made. One quasi-advancement is the streaming of voice and video. The internet has gone from cat videos to award-winning dramas. What began as a supplement to mainstream entertainment has now become the dominant force. Instead of Holly Hunter rushing across a busy TV station, we have Philip DeFranco booting up his iMac. Our tastes have changed, and with it, the production involved.

There is an imbalance here. Broadcast television has always suffered the misgivings of the FCC, even more than its cable brethren. The pragmatic reason for this has always been broadcast television’s availability, or rather its unavoidability. Censors saw to it that obscenities would never come across a child’s view, even inadvertently. But it cannot be denied that the internet is vastly more ubiquitous. Laptop, tablet, and smartphone sales outnumber those of televisions. Even TVs are now ‘smart,’ serving not only their first master but a second web master as well (no pun intended). Shows like Community and Arrested Development were network television shows (on NBC and FOX, respectively) one minute, and web content (on Yahoo! and Netflix, respectively) the next. The form and function of these programs had not substantially changed but they were suddenly free of the FCC’s reign. Virtually identical productions on different platforms are regulated differently, all due to arguments anchored by fears of stagnation.

PyeongChang: The Opening Ceremony

February 16, 2018
New Technology, Regulatory

MJLST Staffer, Amber Peterson

The opening ceremony of the Olympics is always a big show and the 2018 Winter Olympics’ opening ceremony in PyeongChang, South Korea was no exception. Intel created a display that featured a world-record setting 1,218 drones. The display featured drone murmurations that depicted images of a snowboarder that morphed into the Olympic rings using four billion color combinations enabled by onboard LEDs. This display surpassed Intel’s previous Shooting Star drone world record which flew 500 drones simultaneously in Germany in 2016.

Intel’s Shooting Star drones are each about a foot-long, weigh eight ounces, and can fly in formation for up to 20 minutes given the limitations of current lithium-ion battery technology.

While the show is certainly impressive, from a software perspective, it is very much similar to flying a smaller, 300-drone show. The additional drones simply increase the resolution and quality of the images to create more depth. Every drone is operated from a central computer system, which tweaks things such as individual battery life and GPS signal. The drones communicate with this central computer instead of with each other. After animators draw up the show using 3D design software, each individual drone acts as an aerial pixel to fill the night sky.

The only minor tweak that Intel had to make to the design of the drone was to the rotor cages to account for the cold and windy conditions in Pyeongchang. Intel ran test flights in Finland, which has a similar climate to Pyeongchang, to make sure the drones could handle the climate.

This record for the “most unmanned aerial vehicles airborne simultaneously” may have an asterisk however, since the display was pre-recorded after a last minute logistical issue which prevented the record setting drones from flying live at the ceremony. The show that was pre-recorded last December was instead broadcast during the event.

The South Korean laws and regulations that Intel had to comply with are as follows: 1) the maximum height that a drone can fly is 492 feet and if the flights are higher than this distance, government approval is required; 2) drones can only be flown during the day unless government approval has been given; 3) drones must be operated in a range that is viewable from the naked eye; 4) certain zones are banned for drone flights; and 5) drones must always yield to manned aircraft.

Drone law has developed from the explosion of online shopping in Korea. Korean privacy laws however, are some of the strictest in the world so a vexing issue remains as to how to deal with the invasion of privacy from drones. Maintaining a balance between supporting technological advances and being cognizant of protecting safety and individual rights remains an issue that requires further debate.

Changing Families: Time for a Change in Family Law?

February 12, 2018
Family Law, Healthcare, Regulatory, Reproductive Health

MJLST Staffer, Hannah Mosby

Reproductive technology allows individuals to start families where it may not otherwise have been possible. These technologies range from relatively advanced procedures—those using assisted reproductive technology (or “ART,” for short)—to less invasive fertility treatments. ART encompasses procedures like in vitro fertilization—in fact, the CDC defines ART as including “all fertility treatments in which both eggs and embryos are handled” (Link to: https://www.cdc.gov/art/whatis.html)—while other kinds of reproductive assistance range from artificial insemination to self-administered fertility drugs. In a study published by the CDC, the number of ART procedures completed in 2014 in the U.S. alone was almost 170,000. As scientific knowledge grows and new procedures develop, that number will undoubtedly increase.

Individuals choosing to utilize these reproductive technologies, however, can find themselves in legal limbo when it comes to determining parentage. In instances where an individual uses a donor gamete (a sperm or an egg) to conceive, that donor could be a legal parent of the offspring produced—even if that result wasn’t intended by the any of the parties involved. For example, the 2002 version of the Uniform Parentage Act—variations of which have been adopted by many states—provides for the severance of the parental rights of a sperm donor in the event of consent by the “woman,” as well as consent or post-birth action by the “man” assuming paternal rights. If statutory conditions aren’t met, the donor could retain his parental rights over any offspring produced by the procedure. To further complicate things, the use of gendered terms makes it unclear how these statutes apply to same-sex couples. A new version of the Act was proposed in 2017 to comply with the Supreme Court’s recognition of marriage equality in Obergefell v. Hodges, but it has yet to be adopted by any state . Even murkier than the laws governing donor gametes are those governing surrogacy contracts, which some states still refuse to legally recognize. Overall, these laws create an environment where even the most intentional pregnancies can have unintended consequences when it comes to establishing legal parentage.

For further illustration, let’s revisit artificial insemination. Jane and John, a Minnesotan couple, decide to undergo an artificial insemination procedure so that Jane can become pregnant. However, they aren’t married. Pursuant to Minn. Stat. 257.56, the couple’s marriage is a necessary condition for the automatic severance of the sperm donor’s parental status—therefore, since Jane and John aren’t married, the sperm donor retains his parental rights. The statute also requires that the procedure be performed “under the supervision of a licensed physician” in order for severance to occur. If there was no doctor present, then the sperm donor—and not John—would have legal parental status over the offspring produced. The example becomes more complicated if the couple is same-sex rather than heterosexual, because the statute requires the consent of the “husband” to the procedure. Further still, if Jane lived in a different state, the sperm donor might be able to establish parental rights after the fact—even if they were initially severed—by maintaining a relationship with the child. As one can imagine, this makes the use of known donors (rather than anonymous donors) particularly complicated.

Ultimately, ART and related procedures provide opportunities for individuals to create the families they want, but could not otherwise have—an enormously impactful medical development. However, utilization of these procedures can produce legal consequences that are unforeseen—and, often, unwanted—by the parents of children born using these procedures. The state law that exists to govern these procedures is varied and lagging. In the age of marriage equality and donor gametes, such laws are highly inadequate. . . In order for society to reap the biggest benefit from these life-creating technologies, the legal world will have to play a serious game of catch-up.

Airbnb Regulations Spark Controversy, but Have Limited Effect on Super Bowl Market

January 29, 2018
Economics, Internet, Regulatory

MJLST Staffer, Sam Louwagie

As Super Bowl LII descends upon Minneapolis, many Twin Cities residents are hoping to receive a windfall by renting out their homes to visiting Eagles and Patriots fans. City regulations placed last fall on online short-term rental platforms such as AirBnB, which prompted an outcry from those platforms, do not appear to be having much of an effect on the dramatic surge in supply.

The short-term rental market in Minneapolis has been a renter’s market in the opening days since the Super Bowl matchup was set. There are 5,000 placements in the Twin Cities on AirBnB this week, as compared to 1,000 at this time last year, according to the Star Tribune. The flood of posted housing options has limited prices, as the average listing has cost $240 per night—more than usual, but much less than the thousands of dollars some would-be renters had hoped for. One homeowner told the Star Tribune that she had gotten no interest in her 4,000-square-foot, six-bedroom house just five blocks from U.S. Bank Stadium, and had “cut the price drastically.”

The surge in AirBnB listings comes despite ordinances that went into effect in December in both Minneapolis and St. Paul. The cities joined a growing list of major U.S. cities that are passing regulations aimed at ensuring guest safety and making a small cut of tax revenue from the rentals. Minneapolis’ ordinance requires a short-term renter to apply for a license with the city, which costs $46 annually. St. Paul’s license costs $40 per year. As of mid-December, according to MinnPost, only 18 applications had been submitted in Minneapolis and only 32 in St. Paul. That would suggest that many of the thousands of listings during Super Bowl week are likely unlicensed. The cities both say they will notify renters they are not in compliance before taking any enforcement action, but a violation will cost $500 in Minneapolis and $300 in St. Paul.

The online rental platforms themselves had strongly objected to the passage of the ordinances, which would require Airbnb to apply for a short-term rental platform license. This would bring a $10,000 annual fee in St. Paul and a $5,000 large platform fee in Minneapolis. According to MinnPost, as of mid-December, no platforms had submitted an application and it was “unclear whether they [would] comply.” Airbnb said in a statement that it believes the regulations violate the 1996 federal Communications Decency Act, and that “the ordinance violates the legal rights of Airbnb and its community.”

While the city ordinances created controversy in the legal world, they do not seem to be having a similar effect on the ground in Minneapolis, as Super Bowl guests still have a dramatic surplus of renting options.

« 1 … 4 5 6 7 8 … 12 »

Regulatory

Contact Information