By: Kaitlyn Crobar

The basic idea of the Food and Drug Administration (the “FDA”) is to look at approval of food, drugs, medical devices, and other related things for safety and efficacy. Approved products should be safe for the consumer to use and not create their own risks. Drug manufacturers must determine the highest tolerable dose and the potential effects of the drug to ensure safe measures are employed by prescribers and consumers. Efficacy means that the medical product must produce a positive clinical benefit.

            Typically for FDA approval the medical product manufacturers must take several steps. Drug approval requires pre-clinical steps, conducting pre-clinical studies, and conducting clinical trials in various phases which takes on average twelve years to complete. Medical devices must also undergo several pre-market tests and trials which take an average of three to seven years to complete. However, in times of crisis, like during the current COVID-19 epidemic, the FDA allows for Emergency Use Authorizations of both drugs and medical devices under the Food, Drug, and Cosmetic Act.

            The Emergency Use Authorization process moves very fast. Authorization must first be granted from the supplier of a medical product for emergency use. Then an application can be submitted to the FDA for Emergency Use Authorization. Once the FDA gives authorization, the manufacturer can send the medical product to the physician who can then use the product with a patient. In the case of a drug, the patient must give informed consent before receiving the drug and the FDA must be notified of any adverse reactions. This process can occur all within the same day, making it much faster than the typical approval timeline for medical products.

            There are two types of Emergency Use Authorizations. The first allows for medical professionals to use unapproved medical products to diagnose, treat, or prevent a disease in emergency situations. The second allows medical professionals to use an FDA approved medical product in an unapproved way. Either way before mass distribution the products granted Emergency Use Authorizations must undergo a fast-tracked safety and efficacy testing.

            On March 28^th, 2020 the drugs hydroxychloroquine sulfate and chloroquine phosphate were granted Emergency Use Authorizations for the treatment of COVID-19. These drugs are not new drugs, but old drugs that obtained FDA approval for other uses, placing them in the second category of Emergency Use Authorizations. Hydroxychloroquine sulfate has been approved to treat malaria, lupus, and rheumatoid arthritis. Some versions of chloroquine phosphate have been approved to treat malaria. Neither drug has been FDA approved to treat COVID-19.

            The Emergency Use Authorization allows labs to test the effect of the drugs on COVID-19. Lab testing, often completed in the form of in vitro studies, has shown that the drugs help prevent the growth of the virus. With successful initial lab testing, clinical trials for hydroxychloroquine sulfate and chloroquine phosphate have begun. The clinical trials will take time to complete, although the process will be sped up. Doctors and researchers hope to have results in one year as opposed to twelve years.

            Existing drugs that other nations have identified as potentially helpful in curing COVID-19 are favipiravir (a flu drug), remdesivir (a failed Ebola treatment), hydroxychloroquine with azithromycin (an antibiotic), convalescent plasma, and arthritis drugs. Tests are being performed on these drugs in countries like China, Japan, and France. We should not be surprised for the US to announce they have begun trials on these as well. However, the FDA has not yet provided any official Emergency Use Authorization for these drugs. As research continues, it is likely that Emergency Use Authorizations will be granted for new drugs created to combat COVID-19.

            In addition to Emergency Use Authorizations for drugs, the FDA has granted Emergency Use Authorizations for new test kits, personal protective equipment, and ventilators. With the tests for COVID-19 taking several days to return results, many patients waited in worry. Additionally, the need for test kits far overgrew the supply available. This presented the need for more tests and for rapid tests so that patients could have same day results. The FDA has given over thirty Emergency Use Authorizations for both in vitro diagnostic products and molecular-based laboratory developed tests.

            One new diagnostic test that was granted Emergency Use Authorization was created by the BD Company and BioGX Inc. Their test is run on a molecular diagnostic platform that is capable of analyzing hundreds of samples per day. This test is said to yield results in as little as three hours and is expected to increase the number of tests available nationwide by 50,000 per week. While their test has been given Emergency Use Authorization, it has not been approved by the FDA as a medical device to diagnose COVID-19. This means that the test can only be used to detect COVID-19 for as long as the FDA deems that there is an ongoing emergency.

            As we continue to combat COVID-19, we will likely see the number of Emergency Use Authorizations rise rapidly. This is all in part of the dedicated medical professionals who are working tirelessly day in and day out to find solutions in order to end this epidemic.

Sources:

• Emergency Use Authorization, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#LDTs (last visited Apr. 9, 2020).
• Frequently Asked Questions on the Emergency Use Authorization (EUA) for Chloroquine Phosphate and Hydroxychloroquine Sulfate for Certain Hospitalized COVID-19 Patients, U.S. Food and Drug Administration, https://www.fda.gov/media/136784/download (last visited Apr. 9, 2020).
• Gail A. Van Norman, Drugs, Devices, and the FDA: Part 1: An Overview of Approval Process for Drugs, 1 JAAC: Basic to Translational Sci. 170, 170-179 (2016).
• Gail A. Van Norman, Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices, 1 JAAC: Basic to Translational Sci. 277, 277-287 (2016).
• Matthew Herper, When might experimental drugs to treat Covid-19 be ready? A forecast, STAT (Mar. 24, 2020) https://www.statnews.com/2020/03/24/when-might-experimental-drugs-to-treat-covid-19-be-ready-a-forecast/.
• Troy Kirkpatrick, BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in the U.S., BD (Apr. 3, 2020) https://www.bd.com/en-us/company/news-and-media/press-releases/bd-biogx-announce-fda-emergency-use-authorization–for-new-covid-19-diagnostics-for-use-in-us.

By: Ryan Thompson

“Let me be clear: everymother, regardless of race or background, deserves to have a healthy pregnancy and childbirth,” tennis star Serena Williams said in a Facebook post speaking to the racial disparities and bias present in maternal healthcare, following her Vogue cover story where she opened up about her own personal experience. “I personally want all women of all colors to have the best experience they can have.” For the numerous fatal obstetric outcomes resulting from childbirth, there exist clear disparities across racial groups. In 2019, the Centers for Disease Control and Prevention (‘CDC’) reported that Black, Native American, and Alaska Native women are approximately three times more likely to die from pregnancy-related causes than White women.

On December 21, 2018, the Preventing Maternal Deaths Act (H.R. 1318) was signed into law, allowing for the allocation of resources to collect and analyze data on every maternal death in the country. Through this bill, the Federal Government intends to use funds for the establishment and support of existing maternal mortality review committees (‘MMRCs’) in states and tribal nations across the United States. These committees collect data and recommend preventive measures to be taken during the prenatal and postpartum stages. Principal Deputy Director of the CDC, Dr. Ann Schuchat, said: “The bottom line is that too many women are dying [from] largely preventable deaths associated with their pregnancy…we have the means to identify and close gaps in the care they receive, we can and should do more.”

Maternal health amongst black women has garnered much attention in recent years as more data became available. Of the approximate 3.8 million births each year, there are an estimated 700 pregnancy-related deaths. The CDC has reported that while 13 white women die per every 100,000 live births, the figure increases to 42.8 for Black women, and 32.5 for Native American/Alaska Natives women.  These statistics have prompted the Federal government to take action to ensure that there are closer studies of the information available and a dramatic reduction in these figures for women, particularly those for women of color. Though the reasons for the differences remain unclear, the passing of H.R. 1318 was a good step in the right direction.

Current and former presidential candidates have also made it a priority to shed light on this issue, with Senator Kamala Harris even proposing new legislation in her fight against maternal mortality. A reduction in cognitive implicit biases by healthcare providers and a call for improvement facilities through the care provided in the disproportionately affected communities may lead to a better result in the years to come. It is saddening that in one of the leading countries of the world, there exists a reality where black women from all socioeconomic statuses and the death rate for black infants exponentially surpasses that of non-Hispanic white women. Healthcare for all women must be a priority, especially in one of the most precious and vulnerable times of their lives.

References:

Julia Curley, Serena Williams reflects on post-birth complications: ‘It made me stronger’, Today, (Jan. 15, 2018), https://www.today.com/parents/serena-williams-reflects-post-birth-complications-it-made-me-stronger-t121223.

Rob Haskell, Serena Williams on Motherhood, Marriage, and Making Her Comeback, Vogue, (Jan. 10, 2018), https://www.vogue.com/article/serena-williams-vogue-cover-interview-february-2018?mbid=zr_serenawilliams.

Roni Caryn Rabin,Huge Racial Disparities Found in Deaths Linked to Pregnancy, The New York Times, (May 7, 2019), https://www.nytimes.com/2019/05/07/health/pregnancy-deaths-.html.

Emily E. Petersen, MD ET AL,Vital Signs: Pregnancy-Related Deaths, United States, 2011-2015, and Strategies for Prevention, 13 States, 2013-2017, CDC, (May 10, 2019), https://www.cdc.gov/mmwr/volumes/68/wr/mm6818e1.htm.

By: Emily Aziz

Investors eager to benefit from the COVID-19 pandemic rushed to purchase shares of Zoom, a video-calling platform that has seen an increase in surge share prices due to COVID-19. Many traders, however, purchased the wrong stock. On March 25, 2020, the Securities and Exchange Commission (“SEC”) announced the temporary suspension, pursuant to Section 12(k) of the Securities Exchange Act of 1934 (the “Act”), of trading in the securities of Zoom Technologies Inc. due to this confusion. 

Under Section 12(k) of the Act, the Commission is authorized to suspend trading in any security for a period not exceeding 10 business days if, in its opinion, is necessary to protect the public interest and investors. 

Zoom Technologies, a Delaware Corporation that has its principal executive offices in China, primarily engages in technology and communication businesses. The company has not filed a public disclosure statement since 2015. Because of this, the SEC had concerns about the adequacy and accuracy of publicly available information concerning Zoom, including its financial data. Zoom Video Communications, on the other hand, has become incredibly popular amid the coronavirus pandemic as more people work or study from home, and as a result, have become reliant on videoconferencing for maintaining day-to-day communications. 

According to Business Insider, the shares of Zoom Video are up roughly 116 percent year-to date. Zoom Technologies stock was up more than 800 percent year-to-date before its trading halt.  This is not the first time this mix up between the two companies has occurred; In April 2019, Zoom Video went public and Zoom Technologies rallied nearly 100% on the initial public offering day despite, again, not having released any new financial information. 

The temporary suspension ends on April 8, 2020 at 11:59 PM. 

CITATIONS: 

Securities Exchange Act Section 12(k), 15 U.S.C. § 781(k) (1988)

Order of Suspension of Trading, Zoom Technologies, Inc., No. 500-1 (Securities Exchange Comm’n March 25, 2020) 

Jonathan Garber, A company called Zoom Technologies is surging because people think it’s Zoom Video Communications (ZOOM, ZM), Markets Insider (Apr. 18, 2019 10:57 AM) https://markets.businessinsider.com/news/stocks/publicly-listed-zoom-video-communications-traders-buying-zoom-technologies-2019-4-1028122561?utm_source=markets&utm_medium=ingest

Ben Winck, The SEC stopped trading on an over-the-counter stock because people were confusing it with Zoom Video, which has soared amid the coronavirus lockdown, Market Insider (Mar. 26, 2020 12:33 PM) https://markets.businessinsider.com/news/stocks/zoom-technologies-stock-halted-sec-confusion-with-zoom-video-coronavirus-2020-3-1029036453

 Jessica Bursztynsky, SEC pauses Zoom Technologies trading because people think it’s Zoom Video, CNBC (Mar. 26, 2020 11:57 AM) https://www.cnbc.com/2020/03/26/sec-pauses-zoom-technologies-as-traders-confuse-it-with-zoom-video.html

David Canellis, SEC halts $ZOOM after coronavirus traders confuse it for Zoom app, The Next Web (Mar. 27, 2020 2:12 PM) https://thenextweb.com/hardfork/2020/03/27/sec-halts-zoom-after-coronavirus-traders-confuse-it-for-zoom-app/

Photo: Courtesy of Forbes

By: Joseph Mallek

Across the country consumers are seeking cleaning and other products to protect themselves due to the COVID-19 outbreak. Supermarkets and online retailers are struggling to keep up with the rise in demand. Businesses and third-party sellers are now increasing their prices due to this rise in demand and decrease in supply. States attorney generals across the country are receiving and responding to complaints from price gouging consumers.^[1]This practice is normally lawful but in the current health crisis, states are using price gouging statutes to protect consumers.^[2]

Although many states have price gouging statutes, these statutes vary in terminology and penalties. Michigan Gov. Gretchen Whitmer prohibited the resale of a product at a price that is grossly in excess of the purchase price.^[3]Price gouging is penalized in Michigan under the Michigan’s Consumer Protection Act.^[4]Under the governors executive order, the sale of a product “at a price that is more than 20% higher” than the price charged for that product as of March 9 is prohibited.^[5]

In New York, Attorney General Letitia James ordered merchants from price gouging sanitation products and set up a website for consumers to submit price gouging complaints.^[6]Under New York law, it is prohibited to sell goods or services at an “unconscionably excessive price” during a declared state of emergency.^[7]The New York statute reserves the right to the courts to determine whether a price is unconscionably excessive.^[8]Some of the factors the courts consider include the exercise of unfair leverage or unconscionable means and that the “amount of the excess in price is unconscionably extreme.”^[9]

In the past few weeks, consumers have reported that the prices on these items have significantly increased.^[10]Attorney general’s offices around the country are warning sellers against price gouging necessary products.^[11]In addition to consumers reporting abuses, retailers like Amazon must do their part to monitor third-party retailers. As well, it is important for all retailers to keep records and documentation to prove that increases in cost led to the price increase. 

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^[1]Michael Levenson, Price Gouging Complaints Surge Amid Coronavirus Pandemic, The New York Times, https://www.nytimes.com/2020/03/27/us/coronavirus-price-gouging-hand-sanitizer-masks-wipes.html (last visited Mar. 28, 2020).

^[2]Price Gouging Laws by State,FindLaw, https://consumer.findlaw.com/consumer-transactions/price-gouging-laws-by-state.html (last visited Mar. 28, 2020).

^[3]Ryan Jarvi, AG’s Office Receives New COVID-19 Scam Report, More Than 800 Price-gouging Complaints, Official Website of Michigan.gov (https://www.michigan.gov/coronavirus/0,9753,7-406-98158-522347–,00.html) (last visited Mar. 28, 2020).

^[4]Supranote 2. 

^[5]Supra note 3.

^[6]AG James: Price Gouging Will Not Be Tolerated, NYS Attorney General(https://ag.ny.gov/press-release/2020/ag-james-price-gouging-will-not-be-tolerated) (last visited Mar. 28, 2020).

^[7]Supranote 2.

^[8]General Business Law § 396-r

^[9]Id.

^[10]Jessica Guynn, Coronavirus price gouging: eBay bans face masks, hand sanitizer and disinfecting wipes, USA Today(https://www.usatoday.com/story/tech/2020/03/06/coronavirus-price-gouging-ebay-bans-face-masks-hand-sanitizer-sales/4976292002/) (last visited Mar. 28, 2020).

^[11]Jack Nicas, He Has 17,700 Bottles of Hand Sanitizer and Nowhere to Sell Them, The New York Times(https://www.nytimes.com/2020/03/14/technology/coronavirus-purell-wipes-amazon-sellers.html) (last visited Mar. 28, 2020).

By: George Daoud

On its surface, facial recognition software does not seem threatening.  After all, many people use it to unlock their latest iPhone.  In fact, in the hands of law enforcement and federal agencies, it can be used to track and apprehend criminal suspects or victims of crimes.  Companies like Clearview AI, for example, produce facial recognition software that they claim is created for just that purpose.  

The Clearview AI concept is relatively simple.  They provide law enforcement with a tool to upload someone’s picture onto their software, then, the algorithm does the rest.  Through online scraping, the algorithm searches Facebook, Twitter, Google, Instagram, LinkedIn, and endless other web sources, to identify a host of information about the selected person within seconds.  This information can include address, place of work, friends, recent travel, and arrest records.  Needless to say, the usefulness of this type of technology is apparent for certain law enforcement and surveillance purposes, but the question is where to draw the line in terms of privacy.

To further this privacy dilemma, Clearview AI’s entire client list was recently exposed in a massive data breach. This discovery shed light on the fact that Clearview had not only sold its technology to more than 2,200 law enforcement organizations, government agencies, and security companies around the world, but that some of these entities were not law enforcement at all. Well known companies like, Macy’s, Kohl’s, Walmart, and the NBA to name a few, were amongst the Clearview clients that were found to be regularly using the software.  Furthermore, it was discovered that Clearview’s founders gave potential investors and friends free access to the technology, escalating the public unease that already existed.

How Does It Work? 

Facial recognition software is a type of artificial intelligence (AI) that uses ‘machine learning’ and more specifically ‘deep learning’ methods to operate.  Deep learning in AI involves digital algorithms that function similarly to a human brain, and analyze information using artificial neural networks. These neural networks are composed of interconnected neurons, like a brain, that break down and analyze data. Moreover, each neural network is composed of layers, namely an input, hidden, and output layer.  The hidden layer is where an AI algorithm does the majority of its computing.  In order for facial recognition software to function at its maximum potential, it requires a multitude of hidden layers which require more data points to provide greater accuracy and more efficient results.  In these hidden layers, however, is where companies, like Clearview AI, focus their development, and where the public concern for privacy protections lies.

            Since the hidden layers of facial recognition algorithms require more data to be accurate, everyday individuals, and those wrongly suspected, could be subject to massive invasions of privacy through digital data mining.  This not only brings the possibility of Fourth Amendment unreasonable searches and seizures violations into the forefront, but also highlights the level of scrutiny that should be given to personal digital information in the eyes of the law.

Carpenter Concerns

In the 2018 Supreme Court case, Carpenter v. U.S., the Court decided that the warrantless acquisition of a person’s cell-cite information by law enforcement was an unconstitutional search in violation of the Fourth Amendment.  Furthermore, the Court made the distinction between when privacy should and should not be expected.  They deemed that digital cell-cite information given to a third party, like a phone company, and acquired by police, was only pseudo-voluntary.  Therefore, the owner of the information does not have a genuine choice in terms of allowing third-party access.  This pseudo-voluntariness, according to the Court, leads a reasonable person to have a higher expectation of privacy for their information.  If a reasonable person does not think that their digital information would be subject to regular scrutiny by a third-party, then their privacy expectation is inviolable by law enforcement.  That being said, where does that leave a company like Clearview AI?

More Questions Than Answers…

            The crux of the problem with current facial recognition software, is that, unlike in Carpenter, the information that is utilized by law enforcement will not likely hold the same privacy weight in a court of law.  This is mainly due to the fact that the information used, is publicly available and is voluntarily provided to third parties. When one creates an online profile and purposefully puts their digital footprint on the web, the expectation for privacy is assumed to be lessened.  As a result, the liability that companies and law enforcement agencies will face, when using facial recognition to track people, will be drastically reduced. This has the potential to not only increase its unfettered usage in both the private and public sector, but also to incentivize future developers to push the boundaries.  How much and what type of information can be mined and utilized by an algorithm’s hidden layers are open to interpretation.  The only concern companies have right now is getting the most accurate results.  The question is though, who watches the watchmen?    

There is no doubt that there are benefits to facial recognition software, especially in the context of law enforcement.  However, when private companies and individuals can peek into the lives of anyone through a picture, protection at the cost of privacy may not be as good as it sounds. 

Sources: 

Kashmir Hill, The Secretive Company That Might End Privacy as We Know It, The New York Times (Jan. 18, 2020), https://www.nytimes.com/2020/01/18/technology/clearview-privacy-facial-recognition.html.

Ben Gilbert, Clearview AI Scraped Billions of Photos from Social Media to Build a Facial Recognition App That Can ID Anyone — Here’s Everything You Need to Know About the Mysterious Company, Business Insider(Mar. 6, 2020),https://www.businessinsider.com/what-is-clearview-ai-controversial-facial-recognition-startup-2020-3#then-in-march-another-new-york-times-piece-on-the-company-revealed-another-stunning-detail-the-companys-founders-casually-gave-access-to-the-software-to-potential-investors-and-friends-who-immediately-abused-it-6.

Peter Margulies, Surveillance By Algorithm: The NSA, Computerized Intelligence Collection, and Human Rights, Fla. L. Rev. (July 2016), https://scholarship.law.ufl.edu/cgi/viewcontent.cgi?article=1321&context=flr.

Carpenter v. United States, 138 S. Ct. 2206 (2018).

UNIDIR, The Weaponization of Increasingly Autonomous Technologies: Artificial Intelligence a Primer for CCW Delegates, U.N. Docs.No. 8 (2018).  

By: Robert Baurley

By the start of 2020, the Nintendo Company sold approximately 46.79 million units of their “Nintendo Switch” gaming consoles, worldwide.^[i]Arguably, one of the reasons behind the Switch’s success derives from Nintendo’s inclusion of previously published games, on their new mobile gaming device.^[ii]This feature allowed Nintendo to not only expand their video-game library, but also encourage new users to purchase their systems through the option to play familiar games found on older game consoles of competitors. 

This marketing and business strategy, leaves many customers questioning Nintendo’s pricing policies regarding older— “remastered”—video games. For example, Bethesda Studios’ iconic role-playing video game, The Elder Scrolls V: Skyrim was originally released in 2011, since then, Bethesda Studios offered remastered versions of the game on other “next generation game consoles”, including the Playstation 4 and the Xbox One. Today, a remastered copy of Skyrim can be purchased on the Playstation 4 and Xbox One for $39.99 each.^[iii]The exact same remastered game is now available on the Nintendo Switch for a price of $59.99.^[iv]

The natural—and seemingly unjust—frustration associated with Nintendo’s remastered game titles is easily explained. When Nintendo created (and patented) their Nintendo Switch gaming console designs, they also created a proprietary gaming card. Their creation of this new proprietary gaming card platform has now artificially increased the price of Nintendo videogames.^[v]These prices are accurately described as artificial, not only because of the mere fact that that game is the exact same version that can be played on Sony or Microsoft game consoles, but also because the problem was directly created by Nintendo themselves. 

Often coined “the Nintendo Tax,” this increased price for Nintendo games has left customers hoping for change in 2020. One area where Nintendo has decided to meet customers’ needs, is by allowing the integration of third-party memory cards to the Nintendo Switch’s operating system.^[vi]However, Nintendo’s continued direct control over their intellectual property (when it comes to creating game cartridges or system improvements) and unwavering global sales, likely indicates that the Nintendo Tax will continue for as long as the company can collect “taxes” from Switch customers.

So, what does this mean for the future of the Nintendo Switch? Most likely, the Switch will continue to create a niche placement as a mobile gaming console that operates at a higher price point for consumers. Aside from cheaper console options (Nintendo Switch Lite),^[vii]Nintendo’s games will continue to cost customers more to play, in the long run.

Hopefully, overtime Nintendo will loosen the reigns on their proprietary game cards and storage systems. But as of yet, that remains unlikely with an extremely profitable yearly sales model. 

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^[i]Erik Kain, The Nintendo Switch Has Now Sold More Units Than the Super NES, Forbes, (Jan. 2, 2020),https://www.forbes.com/sites/erikkain/2020/01/02/the-nintendo-switch-has-now-sold-more-units-than-the-super-nes/#2278557946cd.

^[ii]Chad Sapieha, Nintendo Switch: The Good, the Bad and the Pricey, postmedia breaking news(Jan. 13, 2017), https://business.financialpost.com/technology/gaming/nintendo-switch-the-good-the-bad-and-the-pricey.

^[iii]Sony Computer Entertainment, https://store.playstation.com/en-us/product/UP1003-CUSA05333_00-SKYRIMHDFULLGAME?emcid=se-pi-225351; Microsoft, https://www.microsoft.com/en-us/p/the-elder-scrolls-v-skyrim-special-edition/BQ1W1T1FC14W?activetab=pivot:overviewtab.

^[iv]Nintendo Co. Ltd., https://www.nintendo.com/games/detail/the-elder-scrolls-v-skyrim-switch/

^[v]Matthew Humphries, Cartridges Mean Switch Games Will Always Cost More, ziff Davis media Inc., (Mar. 13, 2017),https://www.pcmag.com/news/cartridges-mean-switch-games-will-always-cost-more.

^[vi]Matthew Humphries, Nintendo Switch-Branded Micro SD Cards Launching, ziff Davis media Inc., (Jan. 30, 2017), https://www.pcmag.com/news/nintendo-switch-branded-micro-sd-cards-launching. 

^[vii]Scott Stein, Be Happy with the Nintendo Switch You’ve Got, Because You’re Not Getting a New One This Year, CNET Networks Inc., (Mar. 1, 2020), https://www.cnet.com/news/be-happy-with-the-nintendo-switch-youve-got-because-youre-not-getting-a-new-one-this-year/.

By: Monique Witter

We live in a generation where millennials are constantly finding innovative and creative ways to contribute to society through entrepreneurship. Some even go as far as applying for trademark protection through the U.S. Patent and Trademark Office (USPTO). However, the same protection they think will protect their business may be what actually ends it. 

The USPTO introduced a new rule requiring all trademark applications to include an email address for the applicant and the applicant lawyer. Like other contact information, the applicant’s information will be published on USPTO’s public database website. Trademark owners are opposed to this rule. The rule has led to digital versions of scam letters to plague brand owners. The USPTO reason for implementing this rule is to further digitize trademark proceedings to ensure that the agency can still email applicants if they are no longer represented by their attorney. However, trademark lawyers have reacted negatively to this rule. Lawyers have seen their clients get hit with a deluge of scam letters aimed at duping trademark owners into paying fake fees. The mailing address used for those letters are pulled from the same database in which the USPTO will now feature email address.

This rule has invoked a furious reactions from other U.S. trademark counsels. U.S. trademark counsel claims that the USPTO is not considering the privacy of its users, especially in light of new data protection and privacy laws in California (California Consumer Privacy Act) and the European Union (General Data Protection Regulation). According to attorney Stacy J. Grossman, “I appreciate the trademark office’s efforts to prevent fraud, and its need to have necessary information to contact trademark owners. However, I don’t understand why this information has to be published in a public database, and why the failure to include a proper email address could cause a trademark applicant to lose its filing date.”

            Attorney Peter J, Riebling reiterates these issues by noting that the issue is more problematic for well-known public figures. “We have heard from numerous counsels overseas who represent celebrity clients, who are genuinely concerned about the privacy aspects, and the extra burden of having to file a petition to the director of the USPTO for a special waiver of the rule. Yes, a petition may be filed to redact the applicant’s email address in the TSDR documents tab in an ‘extraordinary situation’. And yes, an applicant being a celebrity – and the related privacy and safety concerns – will likely qualify as an extraordinary situation to waive the rule as allowed under TMEP (Trademark Manual of Examining Procedure) §1708. But is not every applicant a ‘celebrity’ in some way or form, if even in their own mind?  What is the legal test the director will use for who is and not a celebrity? Where is the line?”

            In response to the criticism, the USPTO will allow for trademark applicants to create a “unique” email address for dealing with the agency. The new filing released by the USPTO stated “to avoid receiving unsolicited communications at a personal or business email address, applicants and registrants may wish to create an email address specifically for communication and correspondence related to their trademark filings at the USPTO.” The USPTO responded to stakeholders’ concerns regarding the potential for misuse of owner email addresses and for owners represented by attorneys. 

The USPTO responded “in order to address these concerns, and balance them against the need for contact information concerning registrations, the USPTO is reissuing the examination guide. The USPTO is continuing to explore additional improvements, including potentially masking email addresses, and will provide notice of any such system updates in the future.” 

Bill Donahue, After Backlash, USPTO Trying To Hide TM Email Addresses, Law 360, (February 11, 2020), https://advance.lexis.com/document/?pdmfid=1000516&crid=10e9a042-caaf-4c2f-9f2e71e5cf73873a&pddocfullpath=%2Fshared%2Fdocument%2Flegalnews%2Furn%3AcontentItem%3A5Y7J-SBN1-F30T-B05R-00000-00&pddocid=urn%3AcontentItem%3A5Y7J-SBN1-F30T-B05R-00000 00&pdcontentcomponentid=122080&pdteaserkey=sr5&pditab=allpods&ecomp=spnqk&earg=sr5&prid=adad6bc3-12f4-4c9d-b0ee-1130ec9833c1.

 Liz Brodzinski, IP Alert | USPTO Trademark Rule Changes: Electronic Filing, Email Addresses and More, (February 20, 2020) https://bannerwitcoff.com/ip-alert-uspto-trademark-rule-changes-electronic-filing-email-addresses-and-more/.

Tim Lince, USPTO urged to halt applicant email requirement following revolt by trademark attorneys, (February 10, 2020), https://www.worldtrademarkreview.com/governmentpolicy/uspto-urged-halt-applicant-email-requirement-following-revolt-trademark.

 

 

By: Dejaih Johnson

Medicine is rapidly approaching a time where robots will perform surgeries autonomously. From minimally invasive surgery to emergency response and medical robotics, robotically assisted surgeries now represent one of the fastest growing sectors in the medical devices industry. The introduction of these robotic medical devices has made medical operations much more efficient and effective. Surgeons have reported quicker recovery times, less pain, and less blood loss when using a robotic medical device. Though these devices have the capacity to greatly improve the practice of medicine, their usage is not without issue. Over the past twenty years, robotic surgeries have resulted in more than 144 deaths, 1391 injuries, and 8061 device malfunctions. 

Lack of regulation in this area raises many regulatory, ethical, and legal issues. In the European Union (EU), for example, they have yet to establish a clear regulatory framework. Under the Medical Devices Directive, the EU classifies these devices as “Class IIb medical devices”. This means that surgical robots are regulated in the same category as scissors and scalpels. Additionally, the EU does not recognize separate qualifications for surgeons. This approach has proven problematic since surgeons using medical robots require special skills different from that of regular surgeons, such as the ability to control the robot’s manipulators. EU manufacturers are required to seek a certificate for each medical device they wish to sell, but the process is not specific to robotically assisted surgeries. 

On the other hand, the United States has taken a bit of a different approach. Currently, the Food and Drug Administration (FDA) regulates robots as medical devices. The issue, however, lies in the fact that the FDA can regulate them only as medical devices since the FDA lacks the authority to regulate the practice of medicine. Presently, robotic devices in the United States are only used under the supervision of surgeons. For example, surgeons enter calculations and program decisions into their robotically assisted surgical devices. But the United States has failed to fully develop an appropriate regulatory scheme to address this unique issue.

Scholars from varying disciplines have weighed in on the question of how to regulate this practice. One approach, developed by Guang-Zhong Yang, takes into account the uniqueness of medical robotics: the varying levels of autonomy at which the device may operate. As the level of autonomy increases, more stringent regulations and additional requirements would apply. Yang proposes six levels of autonomy for medical robotics, with accompanying levels of regulation and procedure for each. The six levels would break down as follows:

Level 0 – No autonomy: Includes tele-operated robots or prosthetic devices that respond to and follow the user’s command; may also include a surgical robot with motion scaling. 

Level 1 – Robot assistance: Robot provides some mechanical guidance or assistance during a task while the human has continuous control of the system (e.g., surgical robots with virtual fixtures and lower-limb devices with balance control). 

Level 2 – Task autonomy: Robot is autonomous for specific tasks initiated by a human. Operator has discrete, rather than continuous, control of the system (e.g., suturing where the surgeon indicates where a running suture should be placed, and the robot performs the task autonomously while the surgeon monitors and intervenes as needed). 

Level 3 – Conditional autonomy: System generates task strategies but relies on the human to select from among different strategies or to approve an autonomously selected strategy. Robot can perform a task without close oversight (e.g., where active lower-limb prosthetic device can sense the wearer’s desire to move and adjusts automatically without any direct attention from the wearer). 

Level 4 – High autonomy: Robot can make medical decisions but under the supervision of a qualified doctor (e.g., robotic resident who performs the surgery under the supervision of an attending surgeon). 

Level 5 – Full autonomy: No human needed; robot can perform an entire surgery. 

In addition to taking into account the varying levels of autonomy, manufacturers of the device would have to seek licensing and certification from the hospital. The upside of this would be that the framework allows regulators to establish a forward-thinking approach to the robotic medical devices. 

As technology advances faster than regulation, regulators must determine an appropriate framework to address the myriad of issues. Even in the uncertainty, however, it still remains there must be a response to the influx of regulatory, ethical, and legal questions raised. 

References:

Damini Kunwar, Robotic Surgeries Need Regulatory Attention(Jan. 8, 2020), The Regulatory Review, https://www.theregreview.org/2020/01/08/kunwar-robotic-surgeries-need-regulatory-attention/.

Guang-Zhong Yang, et al., Medical robotics – Regulatory, ethical, and legal considerations for increasing levels of autonomy(Mar. 15, 2017), Science Robotics, http://robotics.tch.harvard.edu/publications/pdfs/yang2017medical.pdf.

By: Nolan Hale

Everyone likely has been affected by the cruel disease known as Alzheimer’s. Alzheimer’s is the sixth-leading cause of death in the U.S and according to the Alzheimer’s Association, 5.8 million Americans are living with the Alzheimer’s disease. 

Like many families, my family watched the steady decline of a wonderful human being who we lost too young. My grandmother had the disease when she was in her early 70’s. I remember there being many hurdles that my family had to overcome, like getting the proper treatment and competent nursing home care. While I was young, I remember the stress on the faces of my family members up until the very end. My grandma is one of millions who go through this nightmare and researchers have been trying to find answers. Unfortunately, there have been new developments that are not so promising. 

Last Monday, the Banner Alzheimer’s Institute in Phoenix released the results of a study of people who are destined to develop Alzheimer’s at a young age because of rare gene flaws. The study involved 200 people in the United States and Europe. Unfortunately, the results were a disappointment for scientists. The drugs failed to prevent or slow mental decline of the people who inherited rare gene flaws. Each person had a genetic mutation that almost guaranteed Alzheimer’s in your 30’s to 50’s. While these people account for 1% of Alzheimer’s cases, their brains are similar to those who develop the disease at a later age.

The numbers surrounding Alzheimer’s are staggering and there are many reasons to lose hope. Behind these numbers is something that people seem to forget – the caregivers. According to the Alzheimer’s Association, more than 16 million Americans provide unpaid care for people with Alzheimer’s or dementia. Additionally, these caregivers provide an estimated 18.5 billion hours of care valued at $234 billion.

Is there any hope left? I am sure many of you are wondering. Meet Jack and Beverly Blackard. Jack has been battling Alzheimer’s since 2019. They live in Clarksville, Tennessee and Beverly has been Jack’s full-time caregiver. The Alzheimer’s Association is pushing to pass a three-year policy program that would provide state funded home care and delivered meals for caregivers. Jack and Beverly are advocates for passing the bill by meeting lawmakers and telling their story. Some assembly members are taking notice.  Assembly members Cecilia Aguiar-Curry (D-Winters) and Monique Limón (D- Santa Barbara) introduced Assembly Bill 2047 and Assembly Bill 2048, flanked on the floor of the State Assembly. The bills provide seniors, providers, and caregivers with the tools they need to recognize and plan for an Alzheimer’s diagnosis. Other lawmakers are taking notice and many hope that the bills will take steam. However, like trying to find a cure for Alzheimer’s, passing a bill of this magnitude will take a long time. In the meantime, families should be aware of their options.

According to Karl Steinberg, a California geriatrician, “If you’ve got the resources, where you’ve got family and paid caregivers at home, you’re all set.” However, he states that if you are living in a facility, you are likely to die in the facility. Many Americans have turned to dementia directives created in recent years. The Advance Directives are growing in demand because a patient can refuse oral assisted feeding when they are in an advanced state of dementia and cannot make decisions. It is controversial because terminally ill patients will likely die within two weeks after refusing food and water. The directives drafted in New York and Washington State have drawn hundreds of users. 

People need to be aware that Alzheimer’s can put you in a situation where you can no longer take independent action. There are many different viewpoints as to whether someone should be able to decline medical intervention in advance. Dementia is different for everyone and it may be difficult for doctors to determine when they can no longer make decisions. Some are at home with a caregiver while some are in a facility that may be understaffed and poorly operated. If a doctor does not give food or water because of a directive against the family’s wishes, legal battles could ensue. Where should the doctor draw the line? 

In conclusion, there are many ways to fight Alzheimer’s. The harsh reality is that having Alzheimer’s and caring for one with Alzheimer’s is a long uphill battle. It is best to have a plan in place if you or a loved one is struck with dementia before it is too late. This includes talking with your loved ones about how they would like to be taken care of and financially planning for any disease. There are options like Long term care Medicaid, a special needs trust, and powers of attorney. In the meantime, love your family like Beverly loves Jack – unconditionally and through thick and thin.

JoNel Aleccia,Diagnosed with dementia, she documented her wishes for the end. Then her retirement home said no,Washington Post(Jan. 18, 2020), https://www.washingtonpost.com/health/diagnosed-with-dementia-she-documented-her-wishes-for-the-end-then-her-retirement-home-said-no/2020/01/17/cf63eeaa-3189-11ea-9313-6cba89b1b9fb_story.html.

John Ross,What an Elder Law Attorney Has to Say About Alzheimer’s Disease, cbs19 (Feb. 16, 2020), https://www.cbs19.tv/article/news/health/what-an-elder-law-attorney-has-to-say-about-alzheimers-disease/501-f20f8c29-a4a5-478f-a85c-b2370e2d7bcb.

Assemblymembers Aguiar-Curry and Limón introduce legislative package to tackle Alzheimer’s crisis, Lake County Record-Bee (Feb. 5, 2020), https://www.record-bee.com/2020/02/05/assemblymembers-aguiar-curry-and-limon-introduce-legislative-package-to-tackle-alzheimers-crisis/.

Facts and Figures, Alzheimers Association, https://www.alz.org/alzheimers-dementia/facts-figures (last visited Feb. 18, 2020).

Dementia Advance Directive, End of Life Choices New York,

https://endoflifechoicesny.org/directives/dementia-directive/(last visited Feb. 18, 2020).

Joshua Prestonet al., The Legal Implications of Detecting Alzheimer’s Disease Earlier, AMA Journal of Ethics (Dec. 2016), https://journalofethics.ama-assn.org/article/legal-implications-detecting-alzheimers-disease-earlier/2016-12.

By: Maddie Loewenguth 

In the summer of 2019, after a series of measles outbreaks in New York schools during the previous academic year, a new state law was passed that ended the religious exemption for vaccinations.

Under the new law, Public Health Law Section 2164 and New York Codes, Rules and Regulations Title 10, Subpart 66-1, all children attending public, private or parochial school in New York State must be immune to diphtheria, tetanus, pertussis, measles, mumps, rubella, poliomyelitis, hepatitis B, varicella, and meningococcal in accordance with Advisory Committee on Immunization Practices recommendations. 

In the fall of 2019, all children had to begin getting their vaccines within the first two weeks of classes and complete them by the end of the school year, June 2020. This new law affects about 26,000 New York children who previously obtained religious exemptions. Parents who chose not to vaccinate their children had two options, home school or move out of New York. 

The measles outbreak began in New York City in October of 2018. There were 654 reported cases in New York City and 414 in other parts of the state. The majority of the cases involved unvaccinated children in Hasidic Jewish communities. Dr. Oxibris Barbot, the city’s health commissioner issued a statement that the “best defense against renewed transmission is having a well immunized city.”

The passage of the New York State law took place on June 13^th. New York is now the fifth state following California, Maine, Mississippi and West Virginia, to enact a law requiring children in public schools to be vaccinated and barring all nonmedical exemptions to vaccinations. New York is now considered the state with the strictest policies in the nation. 

Maine’s law does not go into effect until 2021 and makes exceptions for special education students. California, where nonmedical exemptions ended in 2015 allows districts to exempt disabled children. 

All states require children to receive certain vaccinations before entering public school, but every state allows exemptions for children who cannot be vaccinated for medical reasons. There are also states that allow for religious exemptions and for nonreligious exemptions based on personal belief. 

Several states have banned nonmedical exceptions, others have imposed rigorous requirements for parents seeking nonmedical exemptions. For example, in Nebraska, parents must submit “an affidavit signed by a legally authorized representative stating that the immunization conflicts with the tenets and practices of a recognized religious denomination of which the student is a member.” 

Three states also specify that “philosophical arguments” must not be cited as a basis for granting a religious exemption. For example, Alaska law states that “statements indicating philosophical or personal opposition to vaccines will invalidate religious documentation.” 

Parents are advocating on both sides of the issue, those against vaccines, either believe that their children have been injured by previous vaccinations or that it is against their religion to vaccinate their children and are exploring homeschooling options. Parents on the other side are worried about the effect non-vaccinated children will have on the health of their children and are asking schools not to place their children in classrooms with students who have not been vaccinated. 

The most recent news regarding the NYS immunization battle is the introduction of the HPV vaccine to be added to the mandatory list of vaccines for New York schoolchildren. HPV is associated with many cases of cervical cancer and the rates at which parents are vaccinating their children is dropping. It will be interesting to see if the HPV vaccination bill will pass and be added to the list of mandatory vaccines, as well as what states will follow New York in barring non-medical exemptions.  

Sharon Otterman, Get Vaccinated of Leave School: 26,000 N.Y. Children Face a Choice, New York Times, (Sept. 6. 2019) https://www.nytimes.com/2019/09/03/nyregion/measles-vaccine-exemptions-ny.html.

Leksandra Sandstrom, Amid Measles Outbreak, New York closes religious exemption for vaccinations but most states retain it,Pew Research Center(June 28, 2019). https://www.pewresearch.org/fact-tank/2019/06/28/nearly-all-states-allow-religious-exemptions-for-vaccinations/.

N.Y. Pub. Health Law§ 2164 (Consol. 2019). 

David Robinson, HPV Vaccine Joins NY school immunization battle, (Jan 11, 2020). 

https://www.mpnnow.com/news/20200111/hpv-vaccine-joins-ny-school-immunization-battle.