Commentators Struggle to Figure Out Reason for EpiPen Price Increase

By: Lindsey Marie Round

In the wake of a dramatic increase in the price of Mylan’s well-known EpiPen, many articles have been published addressing the public’s concerns, analyzing the situation, and trying to understand the cause of this change. In particular, the article Mylan Tries Again to Quell Pricing Outrage by Offering Generic EpiPen was published by The New York Times addressing Mylan’s response to the issue.[1] Mylan’s attempts to remedy the situation by introducing its own cheaper, generic version of the drug in the upcoming weeks. Since there are currently no significant competitors in the market, this will give consumers another option to choose from.[2] However, this idea has been received with much skepticism, and people are wondering why Mylan does not just cut the price of the brand-name product. Many times brand-name companies will proactively come out a generic version of their drug before competitors introduce generic products to try to continue to receive some revenue that would inevitably be lost to the competitor.[3] However, where there is no current competitor, the reasoning behind this approach has been met with suspicion. More progress regarding the generic option and this healthcare issue are expected in the upcoming weeks as the FDA and Mylan continue to offer new information and insight. It appears that this issue may be the beginning of pharmaceutical and insurance company reforms, which is a hot topic in politics during this election cycle.

[1]Andrew Pollack, Mylan Tries Again to Quell Pricing Outrage by Offering Generic EpiPen, N.Y. Times (Aug. 29, 2016), http://www.nytimes.com/2016/08/30/business/mylan-generic-epipen.html.

[2] Id. (In 2012, litigation ensued which allowed another pharmaceutical company, Teva, to introduce a generic EpiPen beginning in 2015. However, Teva’s product was rejected by the FDA which left Mylan as a monopoly in the field.)

[3] Id.

Baltimore Police Commissioner Secretly Tests Aerial Surveillance Program

By: Samantha Cirillo

With cameras located at street corners, ATMs and even traffic lights, Americans may have a hard time avoiding being recorded on a daily basis. Given the current use of surveillance technology, does the City of Baltimore’s new system which uses airborne cameras to provide a live stream of a 32-mile radius surrounding the city go a step too far?1

Police Commissioner, Kevin Davis, has used the program created by Persistent Surveillance Systems, to record over 300 hours of footage without informing city officials or the citizens of Baltimore.2 Unsurprisingly, civil liberties advocates are outraged by the invasion of privacy without as much as a public hearing.3 Supporters of the program, however, argue that any measures that may effectively reduce the crime rates in a crime stricken community are well worth the invasion.4

The surveillance program works by attaching industrial imaging cameras to the bottom of a plane flown approximately 8,000 feet above the City of Baltimore.5 The images are then transmitted to a computer program that allows analysts to use the continuous stream to move forward and backward through the recorded events.6 The program’s creator, Ross McNutt, refers to the technology as “Google Earth with TiVo Capability”.7

Each morning, the Persistent Surveillance Team receives the previous day’s crime report and working with a former city police officer, the analysts track down the location of the crimes.8 They further document and track every car or individual entering or leaving the crime scene.9 Although the program does not yet have the resolution to detect an individual’s face, analysts can cross reference information from the program with street based surveillance footage.10 Therefore, the tracking capability allows police officers to locate suspects long after the crime has been committed.

The courts have been unable to keep up with the rapid advances made in surveillance technology. With at least five open cases using evidence gathered from McNutt’s program, the court will soon have to face the question of whether this evidence should be admissible in court.11

 

1 Surveillance Program Raises Questions About Tech, Privacy, N.Y. T???? (Aug. 26, 2016), http://www.nytimes.com/aponline/2016/08/26/us/ap-us-baltimore-police-surveillance-.html.


2
Kevin Rector, Commissioner Davis avoids answering questions on secret surveillance program, T?? B???????? S?? (Sept. 8, 2016), http://www.baltimoresun.com/news/maryland/crime/bs-md-ci-davis-on-surveillance-20160906-story.html.1
Surveillance Program Raises Questions About Tech, Privacy, N.Y. T???? (Aug. 26, 2016), http://www.nytimes.com/aponline/2016/08/26/us/ap-us-baltimore-police-surveillance-.html.

3 Monte Reel, Secret Cameras Record Baltimore’s Every Move From Above, B???????? B??????????? (Aug. 23, 2016), https://www.bloomberg.com/features/2016-baltimore-secret-surveillance/.

4 Surveillance Program Raises Questions About Tech, Privacy, N.Y. T???? (Aug. 26, 2016), http://www.nytimes.com/aponline/2016/08/26/us/ap-us-baltimore-police-surveillance-.html.

5 Id.

6 Monte Reel, supra note 3.

7 Id.

8 Id.

9 Id.

10 Id.

11 Surveillance Program Raises Questions About Tech, Privacy, N.Y. T???? (Aug. 26, 2016), http://www.nytimes.com/aponline/2016/08/26/us/ap-us-baltimore-police-surveillance-.html.

FDA Issues Warnings For Prescription Opioids and Benzodiaz

By: Samantha Dente

As part of the agency’s Opioids Action Plan, the FDA issued its strongest warning, a required boxed warning, as well as class-wide changes to drug labeling after significant scientific evidence showed the serious risks associated with combining opioid medications with benzodiazepines.[1]

The Opioids Action Plan is an initiative to revise policies to address the prescription opioid abuse epidemic.[2] Benzodiazepines are a class of central nervous system (CNS) depressant drugs.[3] There are about 400 of them currently on the market.[4] Research found that if used at the same time as opioids for pain management, risks include extreme sleepiness, respiratory depression, coma, and death.[5]

The data review found that physicians were increasingly prescribing opioids and benzodiazepines together.[6] The FDA Commissioner has dubbed these findings as a “public health crisis.”[7] Both are widely used drug classes, and when used together have a lethal effect.[8] However, the resulting drug overdoses and deaths are avoidable and preventable, and the FDA’s warning marks a step in the right direction.  The FDA’s actions are consistent with the Affordable Care Act’s public health approach focused on prevention, treatment, and intervention.

Apple Owes $14.5 Billion in Irish Back Taxes

Eddie Montesdeoca

The European Union stated that Apple owes Ireland $14.5 Billion dollars in back taxes. The basis of which the tax agreement with Apple is anti-competitive, given the disparity that exist between the profits that Apple makes in Ireland compared to what they pay in taxes.[1]   For instance, Apple profited 22 Billion from Ireland in 2011. [2] Of this, the Irish Tax authority found that only 50 Million Euros worth was taxable.[3]  Ireland themselves, do not wish the European Union’s decision to stand.  The agreement between Ireland and Apple was favorable to both parties.  Irish Finance Minister Michael Noonan stated that he profoundly disagreed with the European Union’s decision and would appeal.[4]  If the decision were to stand, it may threaten Ireland’s low corporate tax rate, which remains Ireland’s most attractive draw from multinational companies.[5]  Further, there is doubt that the European Union’s decision would stand if appealed in courts.  Tax experts doubt that the European Union would be able to set a precedent to determine whether countries have applied their tax regulations fairly, even under the guise of them being anti-competitive. [6]

[1] Chee, Foo & Halpin, Padraic, EU hits Apple with $14.5 billion Irish tax demand, Reuters, Aug. 30, 2016; http://www.reuters.com/article/us-eu-apple-taxavoidance-idUSKCN114211

[2] Id.

[3] Id.

[4] Id.

[5] Id.

[6] Kanter, James & Scott, Mark, Apple Owes $14.5 Billion in Back Taxes to Ireland, E.U. Says, Nytimes, Aug. 30, 2016; http://www.nytimes.com/2016/08/31/technology/apple-tax-eu-ireland.html

The Trauma of Violent News on the Internet

Shamsheer Kailey

Violence permeates our world, always has and will continue to as long as mankind believes it has power. In the world of old media – print, radio, and TV – the information presented to the world was edited and controlled. However, with the advent of internet, smartphones, and social media, there is no restriction on the content and amount of visual and written information being directed at people. The effect of prolonged exposure to violence related media through the internet leads to vicarious traumatization.

“A key distinction between consuming news on the internet versus print or TV is the constant access and ability to sink into deep rabbit holes for the former, as the Boston Marathon study demonstrates.” The study, conducted in 2013, compared the acute stress symptoms for those with “direct exposure” to Boston Marathon bombing and those who had only media exposure. The results indicated higher acute stress among those exposed to six or more daily hours of bombing related media exposure.

While traditional media provides a filter – shut off TV or don’t read the newspaper, no such measure is available for social media where comments by users also adds to the offensiveness and trauma. Live streaming of disturbing events and constant access to news and articles allows a person to dig deeper and deeper into details of the incident which results in trauma.

­­______________________________________________________________________________

Teddy Wayne, The Trauma of Violent News on the Internet, N.Y. Times (September 13, 2016), http://www.nytimes.com/2016/09/11/fashion/the-trauma-of-violent-news-on-the-internet.html?_r=0.

FDA Finds Consumer Antiseptic Products are Not Generally Recognized as Safe and Effective

William Salage

On September 2, 2016 the U.S. Food and Drug Administration (FDA) issued a final ruling that 19 ingredients (most importantly triclosan and triclocarban)  in over-the-counter (OTC) consumer antiseptic wash products are not Generally Recognized as Safe and Effective (GRAS/GRAE). This final rule follows the FDA’s commitment to review all OTC products marketed in the U.S. on or before May 1972.

The ruling comes after a proposed rule in 2013 requiring the manufactures of these products to demonstrate both their long term daily use safety and more effective than generic soap through clinical studies pursuant to their review of their GRAS/GRAE status. The manufacturers either failed to clinically demonstrate the safety and effectiveness of their products or did not submit any data at all. The manufacturers now have one year to remove their products containing the newly banned ingredients.

However, the FDA did defer rulemaking on three other ingredients: benzalkonium chloride, benzethonium chloride, and chloroxylenol. Accordingly, this final rulemaking does not apply to these three products. The FDA made this decision in order to allow manufacturers additional time to conduct clinical trials and submit proper data.

How Spy Tech Firms Let Governments See Everything on a Smartphone

Jeffrey Cullen

An Israeli software company called The NSO Group has developed a surveillance tool that enables its user to track an individual’s text messages, calendar records, emails, instant messages, and GPS locations.[1] The program’s name is Pegasus and poses major privacy concerns to citizens worldwide. The NSO Group’s activities have come to light due two anonymous tips received by the New York Times from people who have had dealings with the company. Although this technology is promoted to governments for the purpose of making the world a safer place, there is essentially no check on the invasion of privacy that can occur once this technology is sold to the purchaser.[2] Although all NSO Group contracts with the government are done in accordance with the law, it is in the government’s discretion how deep to dig into an individual’s personal information. This cannot stand to be acceptable and regulations must be set in place to ensure personal privacy.

 

[1] Nicole Perlroth, How Spy Tech Firms Let Governments See Everything on a Smartphone, New York Times (Sept. 2, 2016), http://www.nytimes.com/2016/09/03/technology/nso-group-how-spy-tech-firms-let-governments-see-everything-on-a-smartphone.html?ref=technology&_r=0.

[2] Perlroth, supra note 1.

Smaller Law Firms Face New Challenges in the Realm of Cybersecurity

Christopher W. Folk

Meghan Tribe’s article “As Cybersecurity Hurdles Loom, Smaller Firms Face Big Challenges,” highlights the increasing burden being disproportionately placed on law firms in the context of cybersecurity.[1]  According to this article, at a panel discussion in New York, the Chief Information Officer at Stroock & Stroock & Lavan, Kermit Wallace, stated that the rapid pace of technology in combination with the structure of legal firms and a regulatory landscape in nascent stages conspire to make law firms increasingly vulnerable to cybersecurity breaches.[2]  One of the ongoing issues concerns the fact that personally identifiable information (“PII”) is being safeguarded by more and more businesses, yet once litigation is begun or counsel is engaged, this information flows to law firms.  Consequently,  law firms may have access to or possession of copious amounts of data some of which contains PII as well as confidential and/or proprietary corporate information. Thus, law firms became ripe targets since the smaller firms often times have less stringent cybersecurity protocols than the original sources of the data.  This spells trouble for law firms as they are forced to examine their cybersecurity hygiene protocols and practices.[3]  This article raises some interesting points and Law Firms of all sizes are going to have to consider their exposure with respect to cybersecurity and data breaches.

 

[1] Meghan Tribe, As Cybersecurity Hurdles Loom, Smaller Firms Face Big Challenges (Sept. 27, 2016), http://www.americanlawyer.com/id=1202768670107?keywords=as+cybersecurity+hurdles+loom&publication=TAL+2008.

[2] Id.

[3] See generally, Electronic Data and the Law Firm’s Duty of Care, Delta Risk (Aug, 2015), http://www.delta-risk.net/wp-law-firm-duty/.

Court Rules that Jared Leto Can’t Use Copyright Law to Stop TMZ Leak

Caitlin Holland

Today’s news is often overcome with vivid imagery of war in the middle east, the upcoming Presidential Election, and other important topics. Yet, one recognizable name seems to be in the news more than all of the rest- Taylor Swift.

Swift is again making headlines for being the topic of conversation. Earlier this year, The pop singer was widely reported on because of an alleged invasion into her privacy when rapper Kanye West, and his Wife Kim Kardashian West, shared a recording of a phone call with Swift, seemingly without her consent. Oscar winner Jared Leto, who most recently played the Joker in this summer’s hit, Suicide Squad, is the latest celebrity to be embroiled in a spat with the infamous Swift.

Unique to this situation is Leto’s legal claim to prevent notorious gossip company TMZ from releasing leaked footage. The footage shows Leto listening to Taylor Swift’s album, seemingly for inspiration for his own band’s music, and dismissing her and her music. Leto’s production company, Sisyphus Touring Inc., brought suit in U.S. District Court for the Central District of California claiming that they owned the copyright to the work under work made for hire.

In copyright law, the work made for hire doctrine gives the copyright interest to the employer rather than the creator when the work was made within the creator’s scope of employment.

The District Court held that despite the existence of a written contract, there was no written agreement signed before the footage was filmed. In fact, the work-made-for-hire contract was signed about three months after the footage was filmed. Therefore, Leto’s production company cannot claim that the leaked recording was a work made for hire and therefore cannot claim the copyright. The court cited the controlling case for the Ninth Circuit which states that the work made for hire contract has to be made before the creation of the work. In other words, the contract signed after the creation of the work cannot act retroactively, nor can it work to transfer the rights to the work unless specifically stated.
The use of copyright to restrict the use of a protected work is not unique. Many copyright owners have succeeded in using the monopoly of copyright ownership in order to effectuate censorship. Leto’s  use of copyright law, if it had been successful, would have been the latest in a series of copyright claims made to effectuate censorship which is directly at odds with not only the First Amendment of the United States Constitution, but with the Copyright Clause of the Constitution which empowers the United States Congress to promote the progress of the useful arts, not to restrict it.

Clinton Emails Dominate Conversations During 2016 Election

Lishayne King

In the past, American democracy has often been referenced with respect to the technological developments that define it. Examples of references that have been used to allude to the 2016 campaign include: the Snapchat election, the meme election, or the Facebook election. Curiously, however, the current campaign has been identified not by modern or advanced technology. Rather, the current election season has been described by much older technology, e-mail.

Recurring conversations have focused on Hillary Clinton’s e-mails and the vulnerabilities and dangers that e-mail poses. While e-mail allows for a centralized station for communication, it also provides a false sense of security, failing to remind us that an e-mail can “[reside] on every device that every recipient ever downloaded it on.” Given the many people in different locations that may be involved in a campaign, the convenience of e-mail becomes apparent. Had the Clinton campaign utilized a more current form of technology, such as Slack or Signal, its private communications may not have been as susceptible to seizure.

However, efficiency and security may have better served the Clinton campaign through face-to-face meetings.

Source: Farhad Manjoo, Whoever Wins the White House, This Year’s Big Loser Is Email, New York Times (Oct. 19, 2016), http://www.nytimes.com/2016/10/20/technology/whoever-wins-the-white-house-this-years-big-loser-is-email.html?_r=0.