By Jun Nam, CLS ’20

California Governor Gavin Newsom recently signed an executive order that indefinitely imposed a moratorium on the state’s death penalty.[1] For those familiar with Governor Newsom’s politics, this recent news might come as no surprise.  As mayor of San Francisco, then-Mayor Newsom was an early champion of progressive causes such as same-sex marriage and the legalization of marijuana.[2]  With this latest action, Governor Newsom’s executive order granted reprieve to the 737 inmates currently on death row, withdrew the state’s lethal injection protocol, and closed the death chamber at San Quentin State Prison.[3]  To be sure, this was a significant move, and a victory to be celebrated for those who disagree with the death penalty.  But Governor Newsom’s action came in the form of an executive order, which does not have the permanence of duly enacted law.  Executive orders are a useful tool that executives in recent years have often resorted to when struggling to enact policy through the legislature.  Governor Newsom’s actions reflect in part this broader trend in politics of unilateral executive action that is not backed by the force of the legislative process.

Both Presidents Obama and Trump have used executive orders to carry out their respective agendas.  One of its most significant uses during the Obama presidency was the creation of the Deferred Action for Childhood Arrivals program—or DACA.[4]   Faced with a resistant Congress, President Obama acted unilaterally in creating DACA, which granted temporary reprieve to undocumented immigrants who were illegally brought to the United States as children, so long as they met certain conditions.[5]  As for President Trump, he has used his executive power most notably to implement the “Travel Ban,” and also to affect other policies such as environmental regulations,[6]and recently, to ensure free speech on college campuses.[7]

While executive orders carry the weight and force of law in their implementation, they do not enjoy the permanence of a duly passed law and are easily reversible by a subsequent executive order.  DACA serves as a case in point.  In signing DACA, President Obama himself acknowledged that this was an “imperfect substitute for legislation,” explicitly stating that it was “not a permanent fix.”[8] President Trump proved these statements to be true when he announced in 2017 that he would end DACA,[9]only to be prevented from doing so by the courts.  The issue there was not whether President Trump had the power as the executive to reverse a prior executive order, but rather whether there was adequate justification for such reversal.[10]  The former was not in doubt.

Governor Newsom’s executive order is not immune from these same drawbacks.  While the governor may not face reversals of his executive order any time soon given that he assumed office only months ago, the law itself remains the same: the death penalty is legal in California.  Local prosecutors may still pursue capital punishment if they believe it is warranted.[11] For a more permanent solution, Governor Newsom must act through the legislature.[12]  But this is not easy—even in a staunchly blue state like California.  In as recent as 2016, California voters chose to retain the death penalty, and further, voted to expedite the process for executions.  Unless California citizens have changed their mind, this latest action remains an imperfect and impermanent fix.

[1]Tim Arango, California Death Penalty Suspended; 737 Inmates Get Stay of Execution,N.Y. Times(Mar. 12, 2019), https://www.nytimes.com/2019/03/12/us/california-death-penalty.html.

[2]Carla Marinucci, Newsom Takes His Case Against the Death Penalty to National Stage, Politico(Mar. 15, 2019), https://www.politico.com/states/california/story/2019/03/14/newsom-takes-his-case-against-death-penalty-to-national-stage-914806.

[3]Arango, supranote 1.

[4]Richard Gonzales, 5 Questions About DACA Answered, National Public Radio (N.P.R.)(Sept. 5, 2017), https://www.npr.org/2017/09/05/548754723/5-things-you-should-know-about-daca.

[5]Scott Horsley, Obama Calls Trump’s Reversal on DREAMers ‘Self-Defeating,’ ‘Cruel’, N.P.R.(Sept. 5, 2017), https://www.npr.org/2017/09/05/548708941/obama-calls-trumps-reversal-on-dreamers-self-defeating-cruel.

[6]SeeAidan Quigley, The Agenda: All of Trump’s Major Executive Actions So Far, Politico (Mar. 8, 2017), https://www.politico.com/agenda/story/2017/01/all-trump-executive-actions-000288.

[7]SeeSusan Svrluga, Trump Signs Executive Order on Free Speech on College Campuses, Washington Post(Mar. 21, 2019), https://www.washingtonpost.com/education/2019/03/21/trump-expected-sign-executive-order-free-speech/?utm_term=.99be4eaee75e.

[8]Horsley, supranote 5.

[9]SeeMichael D. Shear & Julie Hirschfeld Davis, Trump Moves to End DACA and Calls on Congress to Act, N.Y. Times(Sept. 5, 2017), https://www.nytimes.com/2017/09/05/us/politics/trump-daca-dreamers-immigration.html.

[10]See Adam Liptak & Michael D. Shear, Supreme Court Turns Down Trump’s Appeal in ‘Dreamers’ Case, N.Y. Times(Feb. 26, 2018), https://www.nytimes.com/2018/02/26/us/politics/supreme-court-trump-daca-dreamers.html.

[11]While prosecutors can still pursue the death penalty, Governor Newsom’s temporary stay remains in effect and would prevent the death penalty from actually being implemented.  SeeThe Editorial Board, A Pause on the Nation’s Biggest Death Row, N.Y. Times(Mar. 13, 2019), https://www.nytimes.com/2019/03/13/opinion/california-death-penalty-gavin-newsom.html.

[12]Alternatively, in California, voters can also change or enact laws directly by proposing an initiative, collecting enough signatures to qualify for the ballot, and winning a majority of votes in an election.

By TJ Wong, CLS ’20

The Internet of Things (IOT) has made a lot of things in life much easier, including making the perfectly cooked toast.[1]The concept refers to the development of internet-connected versions of ordinary objects, which span to everything from coffeemakers to smart cars.[2]While offering endless benefits to daily life, the rapid rise of IOT has generated serious implications for existing computer crime laws, namely the Computer Fraud and Abuse Act (CFAA). Enacted as an amendment to existing laws addressing computer-related criminal activity,[3]the CFAA prohibits accessing a computer without authorization or exceeding authorized access and obtaining information from any “protected computer,” under § 1030(a)(2).[4]Courts have often easily accepted the broad definition of “protected computer” in light of other, more prominent limitations of the CFAA;[5]however, the seemingly endless proliferation of IOT devices justifies reconsidering “protected computer” as a worthy limitation on the breadth of conduct criminalized by the statute.

The CFAA currently defines “protected computer” as a computer that is “exclusively for the use of a financial institution or the United States Government,” or one that is “used in or affecting interstate or foreign commerce or communication.”[6]While the CFAA originally covered only important “federal interest” computers,[7]courts across the country have since interpreted “protected computer” to encompass any computer with an internet connection.[8]Furthermore, a “computer” is defined to essentially cover any device that processes or stores data,[9]including computer networks, databases, cell phones, MP3 players, refrigerators, and temperature control units.[10]As the definition covers anything with a microchip,[11]it includes all IOT devices feeding us data online, such as fitness watches and voice assistants. In the age of IOT, the CFAA’s definition of “protected computers” expands to cover items beyond the plain meaning of the term, as how toasters or refrigerators are not typically viewed in society as “computers.” As “Congress enacted the CFAA in 1984 primarily to address the growing problem of computer hacking,”[12]it seems unlikely that this dramatic expansion was contemplated.

This ever-expanding coverage of the term “protected computer” raises issues of vagueness and overly broad criminalization over the scope of the CFAA. For example, in conjunction with the Ninth Circuit’s interpretation of “without authorization” to cover common practices like password sharing, the extremely broad definition of “protected computer” contributes to potentially criminalizing individuals that share accounts over IOT devices.[13]Instead of using “protected computer” to serve as a significant limitation on the CFAA, courts have dedicated more attention to determining the scope of “without authorization or exceeds authorized access,” as well as relying on prosecutorial discretion to check arbitrary enforcement.[14]However, this approach may prove untenable in light of the uncertainty surrounding other CFAA terms, as circuits have been split over the proper interpretations of “without authorization” and “exceeds authorized access.”[15]

If it is not given enough attention, the expansive definition of “protected computers” could lead to unintended consequences after a circuit declares its stance on “access” or “authorization.” For example, the Second Circuit in United States v. Valle, 807 F.3d 508, 524 (2d Cir. 2015), held that “one ‘accesses a computer without authorization’ if he accesses a computer without permission to do so at all,”[16]along with interpreting “exceeds authorized access” as a limitation on access and not on use.[17]Consider a company that gives employees IOT devices such as voice assistants, indoor security cameras, smart keychains, or fitness watches. Under the Vallecourt’s interpretations of access and authorization, an IT employee of this company, who has a single proper purpose to access the devices for maintenance or troubleshooting, could potentially be free from CFAA liability after observing and obtaining very personal information on other employees – e.g., biometric data, location tracking, online retail or medicine orders, or even video feeds.[18]These cases also involve radically distinct types of information without the statute, as currently constructed, being able to adequately account for these differences.

The broadening scope of “protected computers” to cover everything from computers of financial institutions and the U.S. government to fitness watches, baby monitors, and home thermostats also creates problems for the penalty structure of the CFAA. The CFAA criminalizes intentionally accessing a computer without authorization or exceeding authorized access and obtaining information from any protected computer;[19]however, as mentioned above, the types of information that can be obtained from “protected computers” can be drastically and increasingly different. Nonetheless, a statutory maximum of one-year imprisonment and fines applies, with heightened penalties reserved for offenses with commercial purposes, offenses in furtherance of other unlawful conduct, information valued above $5,000, and individuals with prior CFAA convictions.[20]As such, the statutory penalties could fail to reflect whether the information improperly accessed and obtained was secrets from a government or bank computer, private biometric information, logs of someone’s shopping history, or records of one’s intimate at-home behaviors.[21]By establishing workable and meaningful distinctions between types of internet-connected devices, the CFAA could be more effective in criminalizing and deterring malicious conduct. With the rapid, constant innovation in technology, Congress may never be able to create definitions that stand the test of time; however, in light of the Internet of Things, it’s time that the CFAA is reevaluated to distinguish between traditional “computers” and smart toasters.

[1]Roberto Baldwin, The world now has a smart toaster(Jan. 4, 2017), https://www.engadget.com/2017/01/04/griffin-connects-your-toast-to-your-phone/

[2]Jacob Morgan, A Simple Explanation Of ‘The Internet Of Things’(May 14, 2014), https://www.forbes.com/sites/jacobmorgan/2014/05/13/simple-explanation-internet-things-that-anyone-can-understand/#5b3598c11d09

[3]OFFICE OF LEGAL EDUC., EXEC. OFFICE FOR U.S. ATT’YS, PROSECUTING COMPUTER CRIMES 1-2 (2010), http://www.justice.gov/criminal/cybercrime/docs/ccmanual.pdf(last visited Mar. 29, 2019).

[4]18 U.S.C. § 1030(a)(2)(C).

[5]Namely, interpretations of “without authorization or exceeding authorized access” and prosecutorial discretion. See generallyUnited States v. Yücel, 97 F.Supp.3d 419 (S.D.N.Y.2015); LVRC Holdings LLC v. Brekka, 581 F.3d 1127 (9^thCir. 2009); WEC Carolina Energy Solutions LLC v. Miller, 687 F.3d 199 (4^thCir. 2012); United States v. Rodriguez, 628 F.3d 1258 (11^thCir. 2010); United States v. John, 597 F.3d 263 (5^thCir. 2010); Int’l Airport Ctrs. v. Citrin, 440 F.3d 418 (7^thCir. 2006); EF Cultural Travel BV v. Explorica, Inc., 274 F.3d 577 (1^stCir. 2001).

[6]18 U.S.C. § 1030(e)(2).

[7]Orin S. Kerr, Vagueness Challenges to the Computer Fraud and Abuse Act, 94 Minn. L. Rev. 1561, 1563 (2010).

[8]See Yücel, 97 F.Supp.3d 418-19 (collecting cases and noting “widespread agreement in the case law”).

[9]18 U.S.C. § 1030(e)(1). NOTE: stated exceptions for automatic typewriters, hand held calculators, or “other similar device[s].

[10]SeeUnited States v. Kramer, 631 F.3d 900, 902 (8^thCir. 2011);see alsoUnited States v. Nosal, 844 F.3d 1024, 1032 (9^thCir. 2016) (Nosal II); United States v. Mitra, 405 F.3d 492, 495 (7^thCir. 2005).

[11]Kerr, supranote 7, at 1572-72.

[12]United States v. Nosal, 676 F.3d 854, 858 (9^thCir. 2012).

[13]Nosal, 844 F.3d 1024, 1050-51 (Nosal II) (Reinhardt, J., dissenting).

[14]Yücel, 97 F.Supp.3d 419; see supranote 5.

[15]Tiffany Curtiss, Computer Fraud and Abuse Act Enforcement: Cruel, Unusual, and Due for Reform, 91 Wash. L. Rev. 1813, 1823 (2016).

[16]United States v. Valle, 807 F.3d 508, 524 (2d Cir. 2015).

[17]Id.at 527-28.

[18]These are types of data possibly acquired from popular IOT devices, such as voice assistants, indoor security cameras, smart keychains, and fitness watches.

[19]18 U.S.C. § 1030(a)(2)(A)-(C).

[20]18 U.S.C. § 1030(c)(2)(A)-(C).

[21]Id.; see supranote 18.

By Brannock Furey, CLS ’20

On Tuesday, the Supreme Court will hear oral arguments in Mont v. United States, a supervised release case that turns on two seemingly minor details: the use of the present tense in a federal statute, and a period of 24 days.[1]

Supervised release is designed to help monitor federal offenders after prison, and can result in reincarceration if any conditions set by the court are violated.[2]At issue in Mont is whether a federal district court had jurisdiction to revoke an individual’s supervised release after the initial date on which his supervision was scheduled to end.[3]Citing its decision in United States v. Goins as precedent, the 6th Circuit affirmed the district court’s determination that it could impose the revocation on March 30, despite the fact that the date on which his supervised release was set to expire––March 6––had passed three weeks prior.[4]

As the 6th Circuit noted in Mont, however, a clear circuit split exists between the 6th Circuit’s decision in Goinsand the D.C. Circuit’s decision inUnited States v. Marshregarding the interpretation of 18 U.S.C. § 3624(e), the provision that controls whether a term of supervised released may be suspended.[5]This led to the Supreme Court granting cert.

In their briefs submitted to the Court, Mont’s attorneys and the government disagree as to how § 3624(e) should be construed––and, consequently, over when the clock for a supervised release term should stop and start.[6]Section 3624(e) states that “supervised release does not run during any period in which the person is imprisoned in connection with a conviction for a Federal, State, or local crime unless the imprisonment is for a period of less than 30 consecutive days.”[7]

Mont’s lawyers, citing to Marsh, argue that since the statute uses the present tense, the imprisonment must take place after a conviction in order for the tolling provision to apply.[8]The government sharply contests this emphasis on the present-tense, and points to the phrase “in connection with” to support its argument that the provision can apply to imprisonment both before and after a conviction.[9]

In contrast to Marsh, the government takes the 6th Circuit’s position in Goins.[10]There, the appellate court held a defendant’s supervised-release period should pause during any pretrial detention for an indictment later resulting in a conviction, and where that incarceration was credited as time served.[11]Since the state court credited Mont’s pretrial detention to his 6-year state prison term, the government argues that his incarceration should fall within § 3624(e), and that the federal court therefore had jurisdiction on March 30 due to the tolling of Mont’s supervised release in October 2016.[12]

With more than 8 in 10 federal offenders undergoing supervised release after serving prison sentences, the Court’s decisions regarding the small distinctions at issue in Mont can have large implications for a great number of incarcerated individuals returning to society.[13]

[1]139 S.Ct. 451 (Mem), 202 L.Ed.2d 346.

[2]Congressional Research Service, Supervised Release (Parole): An Overview of Federal Law, 1.

[3]United States v. Mont, 723 Fed.Appx 325, 325 (6th Cir. 2018).

[4]Id. at 326, 328-29 (citing United States v. Goins, 516 F.3d 416 (6th Cir. 2008)).

[5]Id. at 330 (referring to United States v. Marsh, 829 F.3d 705 (D.C. Cir. 2016)).

[6]Fiona Doherty, Argument preview: Justices address circuit split on whether a period of pretrial imprisonment can toll a term of federal supervised release, SCOTUSblog (Feb. 21, 2019, 12:19 PM), https://www.scotusblog.com/2019/02/argument-preview-justices-address-circuit-split-on-whether-a-period-of-pretrial-imprisonment-can-toll-a-term-of-federal-supervised-release/.

[7]18 U.S.C. § 3624(e).

[8]Doherty, supranote 9.

[9]Id.

[10]Id.

[11]Mont, 723 Fed.Appx at 328 (citing Goins, 516 F.3d at 417).

[12]Doherty, supranote 9.

[13]Id.

By Malina Welman, CLS ’20

The 1926 U.S. Supreme Court landmark decision in Euclid v. Ambler Realty Co.— the one where Justice Sutherland infamously called apartment houses a “parasite”— is charged with tacitly giving municipalities across the country the green light to impose exclusionary restrictions on land.[1]Through the use of “snob zoning,” the Court’s decision empowered local governments for decades thereafter to exercise their police powers in order to keep out poor, more diverse city dwellers from white, wealthy suburbs.[2]

Since then, however, many of America’s municipalities have turned over a new leaf, so to speak, by enacting inclusionary policies that instead foster the creation of affordable homes for low- and moderate-income households. In fact, the Lincoln Institute of Land Policy has identified over five hundred programs across twenty-seven states, with New Jersey and California accounting for 65% of all inclusionary programs.[3]Yet, for some state-wide mandates, such as the one in California, these measures have often proved to be more symbolic than they have been effective in making good on their promise to create needed affordable housing opportunities.

In an article reviewing the impact of California’s inclusionary housing law (now over fifty years old), Liam Dillion pointed out that the fundamental problem with the law is that it merely required local governments to produce “prodigious reports to plan for housing – but [did not actually] hold them accountable for any resulting home building.”[4]The result: municipalities developed and adopted plans to build new affordable units in their communities with “‘no intention,’” as Councilman Herb Perez of Bay Area suburb Foster City admitted, “‘of actually building [them].’”[5]Indeed, the city recently went more than five years without approving new development projects despite the high demand for housing.[6]

In an effort to get California back on track, the state Legislature then passed 15 housing-related bills in 2017 to address housing affordability issues.[7]Two noteworthy bills were AB1505, which would require developers to include below-market units in new rental housing projects, and SB 35, which would require cities to approve projects such projects as long as they complied with local zoning regulations and a number of other requirements.[8]Nevertheless, it appears that communities are still attempting to evade their obligation through delay tactics. Such tactics often take the form of prolonged litigation that becomes costly enough to bankrupt developers, thereby resulting in a victory for neighbors without securing a favorable judgment from the court. In Cupertino, the affluent Silicon Valley neighborhood has been doing just that by going head-to-head with developers for over a decade about plans to build up to 2,400 new homes in a nearly-vacant shopping mall with a large percentage reserved for low-income residents.[9]Even in light of California’s new laws, Cupertino residents are resorting to other measures to defer the city council’s approval of the project through a voter referendum. However, their endeavors may ultimately be futile as developers are planning to go ahead with the project.[10]

Now, California’s new governor, Gavin Newsom, is stepping into the arena looking to end an era of inaction on the part of the state’s cities and counties to provide affordable housing. During his first state budget proposal in January, Governor Newsom came out swinging with, what Liam Dillon called, “a radical new step: punishing communities that block homebuilding by withholding state tax dollars.”[11]However, the governor is not waiting around to see whether municipalities heed his words. Weeks later, Governor Newsom filed a lawsuit against Huntington Beach for rezoning a parcel of land to restrict low-income housing.[12]Although it is still too early to tell what impact Governor Newsom’s aggressive policies will have on the affordable housing crisis in the state, it is an approach worth trying.

[1]Euclid v. Ambler Realty Co., 272 U.S. 365, 391, 394 (1926).

[2]See Elizabeth Winkler, “‘Snob Zoning’ is Racial Segregation by Another Name,” Washington Post(Sept. 25, 2017) https://www.washingtonpost.com/news/wonk/wp/2017/09/25/snob-zoning-is-racial-housing-segregation-by-another-name/?utm_term=.86f600b1f0ec.

[3]Rick Jacobus, “Inclusionary Housing: Creating and Maintaining Equitable Communities,” Lincoln Institute of Land Policy (2015), https://www.lincolninst.edu/sites/default/files/pubfiles/inclusionary-housing-full_0.pdf.

[4]Liam Dillon, “California Lawmakers Have Tried for 50 Years to Fix the State’s Housing Crisis. Here’s Why They’ve Failed,” Los Angeles Times(June 29, 2017), https://www.latimes.com/projects/la-pol-ca-housing-supply/.

[5]Id.

[6]Id.

[7]“California Governor Signs Inclusionary Zoning Bill Into Law,” National Apartment Association (Oct. 10, 2017), https://www.naahq.org/news-publications/california-governor-signs-inclusionary-zoning-bill-law.

[8]Id.; Liam Dillon, “New Law Could Break the Stalemate Over Housing On the Site of a Near-Vacant Cupertino Mall,” Los Angeles Times(Dec. 16, 2018), https://www.latimes.com/politics/la-pol-ca-state-law-housing-cupertino-20181216-story.html.

[9]Dillon, “New Law Could Break the Stalemate Over Housing On the Site of a Near-Vacant Cupertino Mall,” Los Angeles Times(Dec. 16, 2018), https://www.latimes.com/politics/la-pol-ca-state-law-housing-cupertino-20181216-story.html.

[10]Id.

[11]Liam Dillon, “Gov. Gavin Newsom Threatens to Cut State Funding From Cities That Don’t Approve Enough Housing,” Los Angeles Times (Jan. 10, 2019), https://www.latimes.com/politics/la-pol-ca-gavin-newsom-housing-money-budget-20190110-story.html.

[12]Allysia Finley, “California’s Liberal Governor Hauls a Conservative City to Court,” Wall Street Journal (Feb. 1, 2019), https://www.wsj.com/articles/californias-liberal-governor-hauls-a-conservative-city-to-court-11549060961.

By Christian Martinez, CLS ’20

“I plead the fifth.” Commonly used in American procedural dramas, this familiar phrase refers to one’s right under the Fifth Amendment not to be compelled in any criminal case to be a witness against oneself.[1]Specifically, the right against self-incrimination prevents the “state from: compelling a defendant to make a testimonial communication to the state that is incriminating.”[2]The Supreme Court has long held that testimonial communications were not limited to oral communications[3]but also includes physical acts that “relate a factual assertion or disclose information.”[4]For example, the act of producing incriminating documents in response to a subpoena is “testimonial” because the very act of producing those documents communicates that the individual knew such documents existed and either possessed or controlled them.[5]Similarly, the act of providing a password or combination to a digital device is also “testimonial” for Fifth Amendment purposes.[6]

Despite this, state and federal courts have held that the compelled use of an individual’s biometric features (e.g. fingerprint) to unlock a digital device is not testimonial and therefore not protected by the Fifth Amendment.[7]However, Magistrate Judge Kandis Westmore of the Northern District of California has recently ruled otherwise.[8]The Government submitted to Judge Westmore warrant applications that included, among other things, a request to compel certain individuals to use their biometric features to unlock digital devices.[9]In denying the application, Judge Westmore held that an individual’s use of biometric features to unlock a digital device is a testimonial communication protected by the Fifth Amendment.[10]Specifically, Judge Westmore reasoned that if an individual could not be compelled to provide a password under the Fifth Amendment, then an individual also could not be compelled to provide a biometric feature to unlock a device because it serves the same function as a password.Furthermore, a successful finger or thumb scan confirms ownership or control over the device and would “expose to the government far more than the most exhaustive search of a house[,]” including medical and financial records (which many smartphone apps provide and protect with biometric features).[11]

Judge Westmore’s decision is a resounding reminder that the law must be quicker to adapt to technological advancements. Under the rule adopted by most courts, there is a meaningful distinction under the Fifth Amendment between using a password to protect your smartphone and using your fingerprint to protect the very same smartphone. The rule has turned what seems like an arbitrary decision for most – whether to use a passcode or biometric feature to secure a digital device – into one with significant privacy ramifications. Worse still, if manufacturers of digital devices opt to remove the password option for securing devices, leaving only the biometric options, this rule would severely limit (if not eliminate) any Fifth Amendment protections as to these devices. As biometrics become increasingly integrated with daily life, it is necessary for courts to avoid the mechanical application of predigital rules to post-digital problems.[12]

[1]U.S. Const. amend. V.

[2]State v. Diamond, 905 N.W.2d 870, 873 (Minn. 2018).

[3]Schmerber v. California, 384 U.S. 757, 763-64 (1966).

[4]Doe v. United States (Doe II), 487 U.S. 201, 209-10 (1988).

[5]U.S. v. Hubbell, 530 U.S. 27, 36 (2000).

[6]In re Grand Jury Subpoena Duces Tecum Dated Mar. 25, 2011, 670 F.3d 1335, 1346 (11th Cir. 2012).

[7]See e.g. In re the Search of [Redacted], 317 F.Supp.3d 523, 535-36 (D.D.C. 2018); In re the Search Warrant Application for [Redacted], 279 F.Supp.3d 800, 807 (N.D. Ill. 2017); State v. Diamond, 905 N.W.2d 870, 875 (2018).

[8]In re Residence in Oakland, California, No. 4-19-70053, 2019 WL 176937, at *3 (N.D. Cal. Jan. 10, 2019).

[9]Id.at *1.

[10]Id.at *3.

[11]Id.at *4.

[12]Riley v. California, 573 U.S. 373, 406-07 (2014).

By Zane Muller, CLS ’20

The past few years have witnessed a dramatic increase in the prevalence and sophistication of algorithms. Advances in machine learning (sometimes called artificial intelligence) have delivered new applications in areas as diverse as credit risk evaluation, criminal sentencing and winning the ancient Chinese strategy game Go.  While they have long been incorporated into software and web interfaces, machine learning algorithms are increasingly used to improve consumer products, and consumers increasingly encounter them in the physical world.  As algorithms further permeate our everyday lives, the law will increasingly have to decide how to handle losses that arise when algorithms fail.

Design defects are intuitive in the case of, say, a lawnmower; but how is a machine learning algorithm “designed”?  In broad terms, machine learning refers to an automated process for identifying relationships between variables in a data set and making predictions based on those relationships.^[1] Those relationships accumulate into a “model”, or algorithm, which can then be used to make predictions or decisions based on new data.^[2] Their design involves two stages: “playing with the data” and “running the model.”[3] In the first stage, designers choose a set of data, determine an outcome goal (ie, “identify the likelihood that a given borrower will default”), and then train the model through various iterations until it independently delivers predictions in line with empirical results. In the second stage, designers “set it loose” in the world to interpret newly-gathered data and use it to deliver predictions or decisions, periodically refining or adjusting it based on the accuracy of results.

Will the law recognize and remedy injuries caused by a “defective” algorithm?  This  question arose in Wickersham v. Ford.[4]  In that case, the plaintiff’s husband committed suicide in the wake of an automobile accident that left him with continuous, extreme pain and debilitating injuries, including the loss of an eye.[5]  One of the  plaintiff’s expert witnesses stated that the cause of this injury was a 146-millisecond delay in the deployment of the seatbelt pre-tensioner and  side airbag.  A second expert witness testified that the cause of this delay was a defect in the design of the car’s Restraint Control Module (RCM), an electronic component that receives sensor data, processes it with an algorithm, and then determines whether and when to pre-tension seat belts and deploy airbags in anticipation of a collision.

In the instant case, the plaintiff’s expert witness alleged that Ford was negligent in designing its algorithm. More specifically, he claimed that the RCM was not properly calibrated for the type of crash the plaintiff’s husband experienced, and that his injuries could have been avoided if Ford had conducted more thorough testing.[6]

One challenge facing plaintiffs is that algorithms are “black boxes” whose workings are often opaque even to their designers. Here, the plaintiff was able to overcome this hurdle because her expert had experience working with a similar algorithm for General Motors.  Furthermore, the court held that the plaintiff alleged sufficiently particular and concrete facts to sustain a claim and denied Ford’s motion for summary judgment.[7]Wickersham presents a case where the causation of an injury by an algorithm’s failure is fairly straightforward; other plaintiffs, whose injuries may be less traceable to algorithmic design, may have a harder time overcoming summary judgment.  Not all algorithm design flaws will be as clear-cut as the failure to quickly deploy an airbag, but could nonetheless cause equally or more serious harms.  As algorithms further penetrate the physical world, these issues will only become more prominent and challenging for courts and lawmakers to resolve.

[1]Kevin P. Murphy, Machine Learning: A Probabilistic Perspective, 1 (2012).

[2]Michael Berry & Gordon Linoff, Data Mining Techniques: For Marketing, Sales, and Customer Relationship Management, 8-11 (2004).

[3]David Lehr & Paul Ohm, Playing With the Data: What Legal Scholars Should Learn about Machine Learning.51 U.C. Davis L. Rev. 653, 670 (2017).

[4]Wickersham v. Ford Motor Company, 194 F.Supp.3d 434 (2016).

[5]Id.at 435.

[6]Id. at 438.

[7]Id. at 436.

By Timothy Sorenson, CLS ’20

The Uniform Probate Code prescribes a set of formalities with which non-holographic wills must comply. Prior to the 2008 round of revisions, the Uniform Probate Code stipulated that a document be written, signed by the testator, and witnessed by two parties.[1]In 2008, the witness requirement was altered to permit notarization as an alternative.[2]Notwithstanding the enhanced flexibility this amendment affords unsophisticated testators, it has not traveled particularly well. In fact, as of 2014, only two state legislatures had enacted the provision.[3]

Despite the UPC’s imprimatur, state courts have also treated notarization disapprovingly. Notarization aside, most courts will not apply the doctrine of substantial performance to rescue a will signed only by one witness.[4]However, state courts have similarly declined to apply the substantial performance doctrine to situations in which a testator has secured only a notary’s signature.[5]Given the resounding rejection of will notarization in state judiciaries and legislative bodies, one can’t help but wonder as to the reasons for its unpopularity.

One commentator outlines the destructive impact of notarized wills on the celebrated ritual and protective functions of will formalities.[6]She argues that traditional witnesses are better gatekeepers than are public notaries. Whereas witnesses ensure that the testator possesses the capacity and intent to create a will (free from undue influence), a public notary merely verifies that the signature belongs to the prospective testator.[7]She also warns that loosening the witness requirement detracts from the “seriousness” of will creation, pushing the entire affair further down the slippery slope towards no formalities.[8]

On the other hand, embracing will notarization increases the number of cases in which courts can give effect to the testator’s probable intent. One prominent commentator disagrees with Rhodes, arguing instead that relaxing the witness requirement would undermine neither the ritual nor the protective functions.[9]With respect to the former, he maintains that most people regard notarization as a formal, legally significant procedure.[10]Thus, allowing notarization as a substitute would not enhance the risk of haphazard will creation. Moreover, given the pervasive perception of notarization’s legal potency, allowing notarized wills to be probated would better reflect general expectations.

He also states that other, widely used estate planning documents do not require witness attestation.[11]This observation is especially salient, as the savvy can nowadays (and often do) dispose of their entire estates (or the bulk thereof) outside of probate. On this point, he argues that the protective concerns with respect to unwitnessed wills are overblown. In addition, he advises that a great deal of “confusion and chance for error” could be avoided by rendering uniform the formalities for estate planning documents.[12]

In states that permit holographic wills as well as those that apply the harmless error rule, a failure to adopt the UPC’s suggested reform is of lesser consequence. However, in a state that offers neither amenity, empirical research would be helpful in constructing a profile of the prototypical decedent denied probate due to misplaced reliance on notarization. My strong suspicion is that prospective testators of lesser means, who are more likely to make use of Internet form wills (without consulting estate planning experts), are most likely to be negatively impacted.

[1]Unif. Probate Code § 2-502 (Unif. Law Comm’n 1990, amended 2010).

[2]Id.

[3]Anne-Marie Rhodes, Notarized Wills, 27 Quinnipiac Prob. L.J. 419, 419 (2014).

[4]See, e.g.,Smith v. Smith, 348 S.W.3d 63 (Ky. App. 2011).

[5]See, e.g.,In re Will of Ferree, 848 A.2d 81 (N.J. Ch. 2003), aff’d, 848 A.2d 1 (N.J. App. 2004).

[6]Anne-Marie Rhodes, Notarized Wills, 27 Quinnipiac Prob. L.J. 419 (2014).

[7]Id. at 429.

[8]Id. at 428.

[9]Lawrence W. Waggoner, The UPC Authorizes Notarized Wills, 34 ACTEC J. 83 (2008).

[10]Id. at 85.

[11]Id. at 86.

[12]Id. at 85.

By Elias Feldman, CLS ’20

The parties in Juliana v. US agree that the lawsuit is not grounded in a “question of science.” On this, I think they are mistaken.

Last week saw the latest development in Juliana v. US, a lawsuit originally filed in 2015 by a group of 21 young plaintiffs alleging that affirmative actions taken by the federal government “have so profoundly damaged our home planet that they threaten plaintiffs’ fundamental constitutional rights to life and liberty.”[1]The trial was expected to begin on October 29^th, but the Supreme Court granted the Justice Department’s request for a temporary stay to halt the case. The Supreme Court denied the Trump administration’s application for stay on November 2^nd, and on November 5^th, the Department of Justice subsequently filed an application for stay with the District of Oregon, as well as a motion to stay and a writ of mandamus with the Ninth Circuit.[2]On November 8^th, the Ninth Circuit granted a temporary stay in part. The suit remains stayed, but Judge Ann Aiken of the District of Oregon has indicated that she would issue a trial date once the Ninth Circuit lifts this latest temporary stay.[3]

The parties dispute the nature of the case. The nonprofit backing the lawsuit, Our Children’s Trust, maintains that “this is not an environmental case, it’s a civil rights case.”[4]The US government, on the other hand, sees the lawsuit as being, in the words of Acting Assistant Attorney General Jeffrey Wood, “a matter of separation of powers and preserving the opportunity in our system of government for those policies to be decided by the elected branches, not the courts.”[5]Although the parties dispute whether this suit is best thought of as involving a constitutional rights question or a separation of powers question, “both sides seem to agree that the case is not a question of the science.”[6]If this is accurate, I believe the parties are ignoring a crucial factual determination (or rather, a mixed question of law and fact) underlying the case: have the government’s policies contributed to a phenomenon which will, in fact, rob young Americans of a “climate system capable of sustaining human life” in a manner that deprives them of their constitutional rights to life and liberty?[7]To be sure, each side has identified issues that will eventually be critical to the case’s disposition. The scope of the plaintiffs’ constitutional rights to life and liberty is a necessary legal determination the courts will have to make, as is whether the remedy sought by the plaintiff—compelling the US government to “take action to fight climate change”—would constitute “an unconstitutional attempt to use a single court to control the entire nation’s energy and climate policy” contrary to separation of power interests.[8]But these questions are both predicated on the factual determination of whether the threatened future injury is probable enough to give the plaintiffs standing to bring the suit at all. As Professor Hessick explains, “the Supreme Court has held that Article III authorizes federal courts to hear claims alleging future injury only when the threatened injury has a real chance of occurring.”[9]Indeed, all injuries have some probability of occurring, so creating justiciability for any prospective harm that could possibly happen would “effectively empower courts to hear hypothetical disputes” in a manner contrary to the judiciary’s Article III mandate to resolve only real cases and controversies.[10]How speculative a future injury is determines whether it is justiciable or not.[11]

Given the politically charged nature of the climate change debate, how much of a threat this phenomenon is as a factual matter is a controversial determination the court, in its capacity as factfinder, will have to make. The Trump administration is openly hostile to climate science identifying climate change as an environmental concern, with the President previously calling global warming a “hoax,” announcing a withdrawal of the United States from the 2015 Paris climate accord, and removing references to “global warming” and “climate change” from government websites.[12]Concern about this phenomenon is sharply split down party lines: 91% of Democrats worry a great deal about global warming, compared to only 33% of Republicans. 67% of Republicans worry “only a little or not at all” about it.[13]These findings and others highlight how Democrats generally view global warming as a very serious problem, whereas Republicans are generally skeptical that it is a man-made problem at all.[14]The court will have to take one position or the other to resolve this question of standing, and will likely investigate whether the threatened injury claimed by the plaintiffs, as a factual matter, has a “real chance” of occurring.

Such a controversial determination of fact by a federal court is not unprecedented. Far more controversial was the Supreme Court’s determination in Roe v. Wade that a fetus, under “historical understanding and practice, the structure of the Constitution, and the jurisprudence of the Court,” is not a person of the kind protected under the Fourteenth Amendment. Justice Blackmun made more of a legal determination there than a factual one, but in effect he codified a factual proposition that was at that time, and still is, at odds with the beliefs of many Americans. The factual determination the court would have to make determining whether or not global warming is a real phenomenon is far less philosophical and more scientific. In fact, the consensus of over 97% of actively publishing climate scientists is that climate-warming trends pose “a growing threat to society.”[15]We can reasonably expect the court to decide whether it will take this assessment as fact, despite widespread opinion to the contrary, and use it to make a legal determination. This would certainly be controversial but would not require the judiciary to encroach upon the legislature’s domain any more than it has done in the past.

[1]Umair Irfan, A major climate change lawsuit is on hold. Again., Vox(accessed November 13, 2018), https://www.vox.com/2018/11/2/18029146/climate-change-lawsuit-children-scotus-supreme-court-juliana, citing to Juliana v. United States, 217 F. Supp. 3d 1224, 1261 (Ore. 2016).

[2]Juliana v. US – Climate Lawsuit, Our Children’s Trust(accessed November 13, 2018), https://www.ourchildrenstrust.org/us/federal-lawsuit/.

[3]Id.

[4]Ifran, supranote 1.

[5]Id.

[6]Id.

[7]Id.

[8]Id.

[9]F. Andrew Hessick, Probablistic Standing, 106 Nw. U. L. Rev.55, 57 (2012).

[10]Id., 56-57.

[11]Id., 57.

[12]Megan Brenan and Lydia Saad, Global Warming Concern Steady Despite Some Partisan Shifts, Gallup(accessed November 13, 2018), https://news.gallup.com/poll/231530/global-warming-concern-steady-despite-partisan-shifts.aspx.

[13]Id.

[14]Id.

[15]Scientific consensus: Earth’s climate is warming, NASA Global Climate Change: Vital Signs of the Planet(accessed November 13, 2018), https://climate.nasa.gov/scientific-consensus/.

By Sean Larner, CLS ’20

A few months ago, the Roberts Court decided a landmark case, Carpenter v. US, that represents the Court’s first meaningful step to protect American privacy interests against government intrusion in the digital age.

Evidentiary exclusion is the only reliable bulwark American citizens have against illegal government intrusion.  However, since the landmark rulings in Weeks v. US, 232 U.S. 383 (1914), where the Supreme Court ruled that evidence obtained pursuant to a Fourth Amendment violation was subject to exclusion, and Mapp v. Ohio, 367 U.S. 643 (1961), which applied the exclusionary rule to the states through the Fourteenth Amendment, the Burger, Rehnquist and especially the Roberts Courts have chipped away at the initially expansive holdings in Weeksand Mapp. Since Mapp, subsequent Courts have prohibited exclusion for good-faith violations, lack of “standing” (which is more substantive than procedural in Fourth Amendment law), knock-and-announce violations, knowing exposure to third-parties, along with grand jury proceedings altogether. But on June 22, 2018, something changed. Amid a spate of conservative decisions in the 2017-2018 Term, the Supreme Court made a shocking announcement in Carpenter v. US, 267 U.S. 132 (2018), that the government’s acquisition of cell-site information location (CLSI), which is the cell phone data obtained from nearby cell towers used to triangulate cell phone locations, constituted a “search” within the Fourth Amendment and was thus susceptible to the Warrant Requirement.

Ever since the decision in Katz v. US, 389 U.S. 347 (1969), over a half-century ago, expanded the scope of Fourth Amendment protections in light of technology’s inexorable advance, there has been a perhaps unanticipated contingency: the birth of the “knowing exposure” doctrine. Under the knowing exposure doctrine, any information shared voluntarily with a third party, no matter how sensitive, from telephone records to bank records, are not within the ambit of the Fourth Amendment. Because an individual “voluntarily” shared his bank records with the bank, government acquisition of those materials does not constitute a “search.” Under the capacious third-party doctrine, a warrant is not needed to compel production––just a subpoena. Katz and the third-party doctrine met a notable limitation in Carpenter.

Timothy Carpenter was convicted of leading a string of armed robberies in multiple states. Under the authority of the Stored Communications Act, the FBI obtained Carpenter’s CLSI, which put him within proximity of four of the robberies. All the FBI needed to prove to get a magistrate judge to sign off on a subpoena was the relevance of the evidence to a criminal investigation, as opposed to the more onerous probable cause requirement needed to obtain a search warrant. The CLSI evidence was adduced at trial and the defense counsel’s objection was overruled. Carpenter was convicted and sentenced to 116 years in federal prison.

In a shocking break from the Court’s longstanding adherence to the third-party doctrine, Chief Justice John Roberts wrote for the majority that CLSI is by its nature a unique type of record that implicates Fourth Amendment concerns about “arbitrary police power” and “too permeating police surveillance,” recognizing that cell phones today have virtually become a part of the human anatomy. Roberts indicated that there may be limitations to the third-party doctrine in the digital era when the type of record at issue is collected automatically and is extraordinarily comprehensive in its reach into the intimate details of a person’s life. The new multifactor analysis under Carpenterconsiders the intimacy, comprehensiveness, expense, retrospectivity and voluntariness of disclosure to third parties, in order to avoid ‘too permeating a police surveillance’ and ‘arbitrary police power.’ The biggest hole in Carpenter, however –– as Justice Kennedy rightly points out in his dissent –– is that private companies like AT&T still have unfettered access to all of our ostensibly private information. Indeed, they sell it to other businesses for billions.

Although it’s unclear how this groundbreaking development in Fourth Amendment law will play out in the lower courts, the CarpenterCourt changed the contours of the third-party doctrine, protecting the CLSI of all Americans from unwarranted government intrusion.

By Anna Iskikian, CLS ’20

The Supreme Court recently upheld Ohio’s process to remove registered voters from the federal voter roll, a process colloquially known as voter “purge” laws.[1]Respondents, consisting of two advocacy groups and an Ohio citizen, argued that Ohio’s process to remove voters violated the National Voter Registration Act (“NVRA”) and the Help Americans Vote Act (“HAVA.”)[2]The NVRA requires states to comply with certain procedures before removing the names of registered voters who have changed residences, such as providing the voter with prior notice.[3]Specifically, respondents contended that Ohio’s process violated the NVRA’s “failure-to-vote” clause.[4]The “failure-to-vote” clause prohibits the use of nonvoting as the grounds for removing registered voters from the voter rolls.[5]

Writing for the majority, Justice Alito concluded that respondents’ reading of  the “failure-to-vote” clause would “cannibalize subsection (d)” of § 20507.[6]Subsection (d) prohibits the removal of a voter’s name on change-of-residence grounds except in the following two situations: (A) the voter confirms in writing his or her change of residence, or (B) the voter fails to respond to a preaddressed, postage prepaid notice and fails to vote or to appear to vote for four years following the date of the notice.[7]Ohio’s Supplemental Process complies with the requirements in subsection (d)[8]. Justice Alito points to HAVA’s amendment of the “failure-to-vote” clause, which provides that “nothing in this shall be construed to prohibit a State from using the procedures described in subsections (c) and (d) to remove an individual from the official list of eligible voters if the individual” has failed to return the preaddressed, postage prepaid notice “and then has not voted . . . in two or more consecutive general elections for Federal office.”[9]HAVA also adds that “no registrant may be removed solelyby reason of a failure to vote.”[10]Accordingly, the majority concluded that because Ohio’s Supplemental Process does not rely on “nonvoting as the sole criterionfor removing a registrant,” it does not violate the NVRA and HAVA.[11]

According to the dissent, the majority’s interpretation renders the failure-to-vote clause superfluous.[12]Respondents and the dissent argued that because, under Ohio’s Supplemental Process, the failure to vote for two years triggers the sending of the preaddressed, postage prepaid notice, Ohio violates the NVRA’s prohibition against the use of nonvoting to remove registrants from the voter roll.[13]This difference in statutory interpretation resulted in the 5-4 decision. In a separate dissent, Justice Sotomayor criticized the majority opinion for “ignore[ing] the history of voter suppression against which the NVRA was enacted and uphold[ing] a program that appears to further the very disenfranchisement of minority and low-income voters that Congress set out to eradicate.”[14]Justice Sotomayor asserted that most states have maintained accurate voter roles without relying on nonvoting to initiate the removal process.[15]

In its brief as amicus for the Petitioner, the United States cited the prevention of “voter fraud” as one of the policy goals that Congress identified in enacting the NVRA.[16]Hustedis one of many examples of the Justice Department shifting its position from one administration to the next; under the Obama administration, the Justice Department argued that Ohio’s process was unlawful.[17]The Justice Department’s shift is consistent with the Trump Administration’s allegations of rampant voter fraud plaguing the 2016 elections. Specifically, President Trump has claimed that ineligible voters, namely, undocumented immigrants, have been casting votes unlawfully. Several reports and publications have published research to debunk these voter fraud allegations or to demonstrate that such claims greatly overstate the extent to which fraudulent voter activity has been occurring.[18]

Even taking these allegations at face value, it is difficult to see how a voter purge law like the Ohio process is effective in preventing or detecting voter fraud. For instance, ineligible voting, duplicate voting, and false registrations have been identified as the most common forms of voter fraud.[19]All of these involve an affirmative act, such as filling out a voter registration form with false information or voting twice. Affirmative acts go unnoticed in a purge scheme like the one at issue in Husted. Instead, Ohio’s removal process operates to remove inactive voters. If voter John Doe were to vote in an election once in Minnesota and then in Ohio, his behavior would go undetected and unprevented under Ohio’s Supplemental Process; in fact, his unlawful duplicate vote would actually shield him from the removal process, by the virtue of the very fact that he voted, albeit unlawfully. Similarly, Ohio’s removal scheme does nothing to filter out ineligible voters from voting. As far the removal process is concerned, those who vote, whether lawfully eligible or not, will not be subject to the notice and removal procedure. Whether one thinks Ohio’s purge scheme is generally good policy in its effort to maintain current and accurate voter rolls is one matter. But at their best, such purge laws prescribe an ineffective mechanism for preventing fraudulent voter activity.

[1]Husted v. A. Philip Randolph Institute, 138 S. Ct. 1833 (2018).

[2]Id. at 1841.

[3]See e.g., 52 U.S.C. § 20507(d)(2) (“[a] notice is described in this paragraph if it is a postage prepaid and pre-addressed return card, sent by forwardable mail, on which the registrant may state his or her current address”).

[4]Husted, 138 S. Ct. 1833, 1841.

[5]See52 U.S.C. § 20507(b)(2) (“Any state program . . . shall not result in the removal of the name of any person from the [list of registered voters] in an election for Federal office by reason of the person’s failure to vote”).

[6]Husted, 138 S. Ct. 1833, 1843.

[7]52 U.S.C. § 20507(d)(1).

[8]Husted, 138 S. Ct. 1833, 1842 (“Ohio’s Supplemental Process follows subsection (d) to the letter.”)

[9]Husted, 138 S. Ct. 1833, 1840 (quoting 52 U.S.C. § 20507(b)(2)).

[10]Id. (quoting 52 U.S.C. § 21083(a)(4)(A)) (emphasis added).

[11]Id. at 1842. (emphasis added).

[12]Id. at 1858-1859

[13]Id.

[14]Id. at 1865

[15]Id.

[16]Husted v. A. Philip Randolph Institute, 2017 WL 3485554 (U.S.), 3 (U.S.,2017)

[17]Brent Kendall & Jess Bravin, Trump’s Justice Department Takes U-Turns on Obama-Era Positions, Wall St. J. (Jan. 5, 2018), https://www.wsj.com/articles/trumps-justice-department-takes-u-turns-on-obama-era-positions-1515148200?mod=article_inline.

[18]Debunking the Voter Fraud Myth,Brennan Ctr. for Justice(Jan. 31, 2017), https://www.brennancenter.org/sites/default/files/analysis/Briefing_Memo_Debunking_Voter_Fraud_Myth.pdf.

[19]A Sampling of Election Fraud Causes from Across the Country, The Heritage Foundation, https://www.heritage.org/sites/default/files/voterfraud_download/VoterFraudCases_5.pdf. (last visited Nov. 7, 2018).

By Maximilian Auerbach, CLS ’20

In a recent immigration decision, Matter of A-B-,27 I&N Dec. 316 (A.G. 2018), Attorney General Jeff Sessions significantly limited the ability of victims of private violence to gain asylum in the United States. This decision will pose particular difficulty for those seeking asylum based on domestic or gang violence.

Under the Immigration and Nationality Act (INA), the Attorney General may grant asylum to aliens who have (1) endured persecution or hold a “well-founded fear of future persecution,” (2) “on account of ‘race, religion, nationality, membership in a particular social group, or political opinion.”[1]Proving membership in a particular social group involves meeting three further requirements: (1) that the alleged group contains members “shar[ing] a common immutable characteristic,” (2) that the alleged group is “defined with particularity,” and (3) that the alleged group is “socially distinct within the society in question.”[2]. An asylum seeker must then show that such membership represented the “central reason for their persecution.”[3]

Matter of A-R-C-G-,26 I&N Dec. 338 (BIA 2014) allowed domestic violence victims to premise asylum requests on their membership in a particular social group. By recognizing that “married women in Guatemala who are unable to leave their relationship” constitutes a particular social group,[4], A-R-C-G-set the stage for women in similar circumstances to seek asylum on analogous bases. Indeed, in Matter of A-B- (BIA Dec. 8, 2016),the Board of Immigration initially granted the respondent asylum based on her status as an “El Salvadoran wom[an]… unable to leave [her] domestic relationship where [she has] children in common.”[5]

The Attorney General rejected this decision and, in so doing, overturned A-R-C-G-.[6]Multiple doubts about the legitimacy of the social group identified in A-R-C-G- motivated his decision. First, Sessions argued that, since domestic violence produces the inability to leave partially defining that social group, the group’s only “narrowing characteristic” is the persecution itself.[7]Sessions, citing previous immigration and courts of appeals precedent, found that one must identify a particular social group existing independently of persecution, such that the A-R-C-G- group would not qualify.[8]Second, Sessions claimed that this group lacks the requisite social recognition and immutability to qualify for asylum.[9]Sessions contrasted Guatemalan women with “a particular tribe or clan:” while the latter group possesses a “highly recognizable, immutable characteristic,” there is little evidence, according to Sessions, that the former group shares such characteristics in Guatemala.[10]Lastly, Sessions questioned whether membership in this group would ever serve as the “central reason” for one’s persecution.[11]These concerns with the particular group led Sessions to the broad conclusion that victims of domestic or gang violence would rarely qualify for asylum.[12]

Going forward, this decision will significantly limit the ability of such victims to pursue asylum. This fact results from the significant leeway possessed by the Attorney General to construe the INA. Since it is up to the Attorney General to construe ambiguous portions of the INA, and courts of appeals have unanimously found the language “particular social group” ambiguous,[13]A-B-will control until a subsequent Attorney General changes Sessions’ interpretation. Furthermore, given the well-established ambiguity of the statute, courts will defer to this agency definition.[14]  As such, those fleeing private violence in their home countries will need to develop alternate paths to asylum.

[1]Matter of A-B-, 27 I&N Dec. at 318 (citing 8 U.S.C. §§ 1101(a)(42)(A), 1158(b)(1)(a), (b)(i)).

[2]Id.

[3]Id.

[4]Matter of A-R-C-G-, 26 I&N Dec. 338, 389 (BIA 2014).

[5]Id.

[6]SeeA-B-, 27 I&N Dec. at 316.

[7]Id. at 335.

[8]Id.

[9]Id. at 336.

[10]Id.

[11]See A-B-, 27 I&N Dec. at 337

[12]SeeA-B-, 27 I&N Dec. at 320.

[13]See id. at 325-26, A-B-

[14]SeeNat’l Cable & Telecomms. Ass’n v. Brand X Internet Servs., 545 U.S. 967 (2005); Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984).

By Elizabeth Parizh, CLS ’20

With the midterm elections coming up, you might be thinking about how you’re going to vote. You might be looking at which candidates you agree with most, what policies are most important to you, and the potential consequences from these decisions. But if you are a resident of Florida, as well as Iowa, Kentucky, or Virginia[1], and have ever been convicted of a felony, you cannot take part in any of this[2]. Even if the conviction is fifty years old and you completed your sentence thirty years ago, you likely are unable to vote. This is in Section 4 of Article VI of the Florida Constitution, written back in 1968[3].

The Eleventh Circuit upheld this law in Johnson v. Governor of Fla., finding it in violation of neither the Voting Rights Act[4]nor the Constitution.[5]Plaintiffs argued that the disenfranchisement provision was racially motivated and particularly impacted black men.[6]The court disagreed, holding that the statute was passed after African Americans had a right to vote and the provision was race-neutral[7].

You could try to go through the clemency board, comprised of the governor and his cabinet, to get your rights restored, but you would have to wait at least five years to even apply and there are currently thousands of people waiting in the backlog[8]. A federal judge ruled this process unconstitutional in Hand v. Scott, but the state is appealing[9], with a stay granted in the meantime[10]. In the case, the court found the process violated the First and Fourteenth Amendments of the U.S. Constitution because it was subjective, arbitrary, and discriminatory[11]. This violated the First Amendment by violating felons’ right to free association and expression[12], and the Fourteenth because courts have historically avoided such acts of grace[13]. However, the judge upheld voter disenfranchisement itself, finding issue only with how Florida went about restoring it[14].

Amendment 4 is attempting to change the entire system. It was intended to “automatically restore the right to vote for people with prior felony convictions, except those convicted of murder or a felony sexual offense, upon completion of their sentences.”[15]The sentence includes “prison, parole, and probation.”[16]If this proposal passes, it would restore voting rights to almost 1.5 million Floridians[17].

The movement to get the amendment on the ballot has been pushed in large part by grassroots organizations. The Florida Rights Restoration got over a million signatures[18]and 5.5 million dollars[19]. It needs 60% approval rating to pass[20], which some are more optimistic of reaching than others.

Proponents argue that Florida is one of only four states with such voter disenfranchisement and the sentence itself is meant to provide adequate punishment[21]. Further, allowing ex-felons to vote would help them become productive members of society[22], which would allow them to “contribute $365 million to Florida’s economy.” [23]As Angel Sanchez, a disenfranchised voter currently in law school and pushing this bill, indicated, “We really believe in redemption and second chances, and we believe in Florida, once a debt is paid, it’s paid in full.”[24]At the same time, some oppose the proposal, claiming the Legislature should be the one to address the issue and grant voting rights to those who deserve it[25]. Still others are opposed because it excludes those convicted of murder or sex offenses[26]. The argument is that a murder or sex offense decades previously should not impact voting rights, especially considering those convicted of voter fraud or similar offenses will be able to regain their right.[27]

To learn more about this movement, visit secondchancesfl.org[28].

[1]Amendment 4: Voting Rights Restoration for Felons Initiative, Florida Association of Counties,

[2]https://ballotpedia.org/Florida_Amendment_4,_Voting_Rights_Restoration_for_Felons_Initiative_(2018).

[3]Id.

[4]Johnson v. Governor of Fla., 405 F.3d 1214, 1234 (11th Cir. 2005).

[5]Id. at 1226-27.

[6]Id. at 1217.

[7]Id.at 1219.

[8]Layron Livingston, Passing of Amendment 4 could increase number of Florida voters by nearly 1.5 million, Local10, https://www.local10.com/news/elections/passing-of-amendment-4-could-increase-number-of-florida-voters-by-nearly-15-million.

[9]Id.

[10]Steve Bousquet, A long, hot summer of building support to grant felons the right to vote, Tampa Bay Times, https://www.tampabay.com/florida-politics/buzz/2018/07/19/a-long-hot-summer-of-building-support-to-grant-felons-the-right-to-vote/.

[11]Hand v. Scott, 285 F. Supp. 3d 1289, 1300 (N.D. Fla. 2018).

[12]Id. at 1295-96.

[13]Id. at 1307.

[14]Id. at 1300.

[15]Amendment 4, supra note 1.

[16]Id.

[17]Livingston, supra note 8.

[18]Id.

[19]Bousquet,supra note 10.

[20]Id.

[21]Ginny Beagan, Vote yes or no for Amendment 4? Here’s what 6 Florida newspapers recommend, Florida TOday,

[22]Id.

[23]Bousquet,supra note 10.

[24]Livingston, supra note 8.

[25]Beagan,supra note 21.

[26]Lynn Hatter, Critic Of Voting Restoration Initiative Says Amendment 4 Pits Felons Against Each Other, WLRN, http://www.wlrn.org/post/critic-voting-restoration-initiative-says-amendment-4-pits-felons-against-each-other.

[27]Id.

[28]Second Chances, https://secondchancesfl.org/.

By Natalie Dugan, CLS ’20

A civil-rights law suit filed against Harvard in 2014 went to trial in a federal district court in Boston last week. The plaintiff, a group called Student for Fair Admissions, alleges that Harvard’s undergraduate program discriminates against Asian-Americans.[1]A report from Harvard’s own Office of Institutional Research reported that Asian-Americans were accepted at a lower rate than whites, despite scoring higher on test scores, and being rated higher by admissions officers in extracurriculars.[2]While the plaintiff believes this trend is explained by discrimination, Harvard argues that it’s not.[3]Moreover, Harvard, and several other elite universities, contend that if the admissions process must proceed in a race-neutral fashion, diverse environments will not be possible.[4]

The Supreme Court has tackled the issue of affirmative action in elite universities a number of times, and set the relevant standard in two landmark cases: Grutter v. Bollinger and Gratz v. Bollinger. In the former case, a white student alleged that he was rejected from the University of Michigan’s Law program due to his race.[5]The Court held that a narrowly tailored affirmative action system is Constitutional if it relates to what the Court saw as a legitimate and compelling interest in increasing the diversity of the student body.[6]Moreover, the Court explained that a narrowly tailored system is one that does not plainly rely on racial quotas, but is rather a holistic evaluation of the many factors that might impact an application (personal statement, extracurriculars, grades, etc).[7]In Gratz v. Bollinger, the Court similarly held that formulaic affirmative action schemes violate equal protection, and that individualized consideration must be afforded to all candidates.[8]

In opening statements last week, plaintiff’s attorney Adam Mortara argued that Asian Americans outscore white applicants in every single category, except for the “subjective personal rating”.[9]And in this way, the plaintiff aims to distinguish Harvard’s practices from that of Supreme Court sanctioned affirmative action, and classify it instead as racial discrimination.[10]Harvard, however, emphasized that race never plays a negative role in the admissions process, but can only be positive.[11]Notably, on the plaintiff’s side is attorney Edward Blum, a conservative lawyer with a long track record of challenging affirmative action.[12]Some believe that this case is poised for the Supreme Court – and with Judge Kavanaugh now presiding, it’s possible the standard for affirmative action will change significantly.[13]

[1]Jeannie Suk Gersen, Anti-Asian Bias, Not Affirmative Action, Is on Trial in the Harvard Case, The New Yorker (Oct. 11, 2018), https://www.newyorker.com/news/our-columnists/anti-asian-bias-not-affirmative-action-is-on-trial-in-the-harvard-case.

[2]Id.

[3]Id.

[4]Id.

[5]Grutter v. Bollinger, 539 U.S. 306, 123 S. Ct. 2325 (2003).

[6]Id.

[7]Id.

[8]Gratz v. Bollinger, 539 U.S. 244, 123 S. Ct. 2411 (2003).

[9]Adam Harris, What the Harvard Trial Is Really About, The Atlantic(Oct. 15, 2018), https://www.theatlantic.com/education/archive/2018/10/harvard-really-about-affirmative-action/573064/.

[10]Jeannie Suk Gersen, Anti-Asian Bias, Not Affirmative Action, Is on Trial in the Harvard Case, The New Yorker (Oct. 11, 2018), https://www.newyorker.com/news/our-columnists/anti-asian-bias-not-affirmative-action-is-on-trial-in-the-harvard-case.

[11]Adam Harris, What the Harvard Trial Is Really About, The Atlantic(Oct. 15, 2018), https://www.theatlantic.com/education/archive/2018/10/harvard-really-about-affirmative-action/573064/.

[12]Jeannie Suk Gersen, Anti-Asian Bias, Not Affirmative Action, Is on Trial in the Harvard Case, The New Yorker (Oct. 11, 2018), https://www.newyorker.com/news/our-columnists/anti-asian-bias-not-affirmative-action-is-on-trial-in-the-harvard-case.

[13]Adam Harris, The Harvard Case Is About the Future of Affirmative Action, The Atlantic(Oct. 15, 2018), https://www.theatlantic.com/education/archive/2018/10/harvards-affirmative-action-trial-gets-underway/572989/.

By Aryeh Mellman, CLS ’20

In a case that has important implications for the future of the gig economy, the 9^thCircuit ruled in O’Connor v. Uber Technologies that Uber drivers who were suing to be classified as employees rather than independent contractors could not sue as a class and would have to litigate their claims individually.[1]

The reason for the suit boils down to the differences between employees and independent contractors. Generally, contractors have more flexibility (drivers can work for both Uber and Lyft at the same time and can set their own hours), but employees are legally entitled to a broader set of benefits, including health insurance. In this case, contractors working for Uber also had to sign an arbitration agreement waiving their right to sue Uber as a class, though the agreement did contain an opt-out provision. Notably, the court had previously held in Mohamed v. Uber Technologies, Inc.[2]because it contained an opt-out provision, the arbitration agreement was not unconscionable and gave drivers a real opportunity to exercise that option if they so chose.

The court rejected both of plaintiffs’ lines of reasoning claiming that the arbitration agreements were unenforceable. First, it disposed of plaintiffs’ argument that “the lead plaintiffs in O’Connor had constructively opted out of arbitration on behalf of the entire class” on the grounds that plaintiffs’ sole authority for that proposition rested on a state supreme court case that did not reach federal law.[3]Plaintiffs’ second argument was that arbitration agreements that contain class action waivers, as Uber’s arbitration agreements did, are illegal under the National Labor Relations Act. However, plaintiffs had to withdraw this argument as their position was squarely rejected in Epic Systems Corp. v. Lewis, decided as O’Connor was ongoing.[4]

The class of drivers suing Uber included some plaintiffs who agreed to the arbitration provision, thus waiving their right to participate in a class action. Since the court held the arbitration agreements to be enforceable, they deemed those plaintiffs improperly part of the class and reversed the certification orders.

The decision is a clear victory for Uber, which had at one point agreed to settle with the drivers for $100 million.[5]Conversely, plaintiffs have two unattractive options remaining. They can appeal for an en banc hearing, in which case they would have to win a majority of 9^th Circuit judges’ votes just to hear the case and then would have to win on the merits. Alternatively, Uber drivers can litigate their cases individually in arbitration, which plaintiffs’ lawyer has said is already occurring.[6]Of course, litigating thousands of cases individually consumes far more time and resources than litigating as a class. It may also lead to inconsistent judgments, especially since arbitration proceedings are not bound by precedent. Barring a judicial reversal though, that seems to be the only option left available to Uber drivers unhappy with their employment status.

[1]O’Connor v. Uber Technologies Inc., 2018 WL 4568553.

[2]Mohamed v. Uber Technologies Inc., 848 F.3d 1201 (9^thCir. 2016).

[3]O’Connor, 2018 WL 4568553, 14.

[4]Epic Systems Corp. v. Lewis, 138 S. Ct. 1612 (2018).

[5]Andrew J. Hawkins, Uber Scores a Big Win in Legal Fight to Keep Drivers as Independent Contractors, The Verge (September 25, 2018). https://www.theverge.com/2018/9/25/17901284/uber-drivers-independent-contractors-vs-employees-legal-fight.

[6]Jonathan Stempel,No Class Action for Unhappy Uber Drivers: U.S. Appeals Court, Reuters (September 25, 2018) https://www.reuters.com/article/us-uber-lawsuits/uber-can-force-drivers-into-arbitration-u-s-appeals-court-idUSKCN1M526F.

By Edmund Costikyan, CLS ’20

If you’re a true crime podcast fan, you may have heard the name Joey Watkins. Watkins is one of a small but growing group of defendants who has had his case reinvestigated and told to an audience of millions of podcast subscribers. Serial, a podcast known for its deeply affecting series on the case of Adnan Syed, initially popularized this phenomenon. Watkins, who, like Syed, has maintained his claim of innocence throughout nearly two decades of incarceration, is represented by the Georgia Innocence Project, and had his story told on the true crime podcast Undisclosed, which is dedicated to investigating potential wrongful convictions. However, it is not his strong claim of actual innocence which makes a recent decision by the Georgia Superior Court of Walker County in his case problematic. Rather, this decision raises a long-standing justice system concern — the protection of jurors once they have been discharged from their duty from “[v]exatious or harassing investigations[.]” Model Code of Prof’l Responsibility EC 7-30 (Am. Bar Ass’n 1983).

In Watkins v. Ballinger, Watkin’s habeas petition to the Superior Court, one of the grounds upon which Watkins challenges his incarceration is that “[j]uror misconduct resulted in a violation of [his] rights under the Fifth, Sixth, and 14th Amendments… and Article I, Section I, Paragraphs I and XIV or the Georgia Constitution…” Watkins Application for Writ of Habeas at 5 Filed Jan 18 2017.  The alleged juror misconduct, discovered fifteen years after Watkins’ conviction during a 2016 interview with Undisclosed reporter and attorney Susan Simpson, was that one juror, during deliberations, had taken it upon herself to do a drive test of an alleged aspect of the charged offense, and, as a result of that independent drive test, changed her vote from not guilty to guilty.  Watkins Application for Writ of Habeas Corpus, Juror Aff. 5 Filed Jan 18 2017. This is a violation of the directions the jury was given by the trial court, which instructed the jurors that they “ha[d] to base [their] decision in any trial like this on what [they] hear[d] in the courtroom from the witness stand and [they] c[ouldn’t] go investigating anything on [their] own.” Addendum to Part II of Watkins Application for Writ of Habeas at 2, quoting Trial Transcript at 411-412. As such, Watkins claim was that this violated his constitutional rights “to be present at all critical stages of his trial and to confront the witnesses against him.” Watkins Application for Writ of Habeas at 5 Filed Jan 18 2017.

The court’s Judge Don W. Thompson declined to address the merits of the argument, instead dismissing the petition for habeas corpus relief as untimely on the grounds that Watkins, “with the exercise of due diligence, could have spoken with this juror once his trial was over in 2001 to determine whether any juror misconduct had occurred.” Order Dismissing Petition as Untimely and Successive at 5 Filed Jul 19 2018. He determined that the statute allowing Watkins to petition for habeas relief contains a one-year statute of limitations which starts to run “when a person knows or through due diligence could discover the vital facts, regardless of when their legal significance is discovered.” Id. at 4, citing Cole v. Warden, 768 F.3d 1150 (11th Cir. 2014), cert,denied, 135 S.Ct. 1905 (2015). See also O.C.G.A. § 9-14-42(c); 28 U.S.C. § 2244(d)(1)(D).

This has problematic implications for defendants and their attorneys in Georgia, but perhaps even more for the jurors themselves. If any potential juror misconduct must be discovered and brought to the attention of the court within one year in order to be considered timely, this means that every defendant who loses at trial has a pressing incentive to immediately and exhaustively interview every juror about all aspects of their deliberations in the hope of discovering potentially actionable juror misconduct. While both the ABA Model Code of Professional Responsibility and the Georgia Rules of Professional Conduct state that a lawyer may communicate with jurors after a trial, these communications must be limited and are often regarded with skepticism. Model Code of Prof’l Responsibility EC 7-29  (Am. Bar Ass’n 1983). The Georgia Rules of Professional Conduct Rule 3.5 provides, in pertinent part, that “[A] lawyer shall not, without regard to whether the lawyer represents a client in the matter:

3. communicate with a juror or prospective juror after discharge of the jury if:

1. 1. the communication is prohibited by law or court order; or
   2. the juror has made known to the lawyer a desire not to communicate; or
   3. the communication involves misrepresentation, coercion, duress or harassment.”

Given these concerns, does it make sense for the Georgia courts to require that an attorney, in order to have acted in due diligence, must contact all the jurors who had decided her client’s verdict and interview them about what transpired in the jury room within such a short period after the trial, and ensure that she gets the information then or else relinquish her client’s chance to appeal on the grounds of any juror misconduct? Doesn’t such a requirement implicate concerns that jurors will feel coerced, harassed, or under duress by the interviews the Walker County Superior Court now makes mandatory in this decision’s definition of due diligence? Hopefully, Watkins will be permitted to appeal this ruling to the Georgia Supreme Court, and we will see how it responds to these questions.

If you’d like to learn more about Watkins’s case, you can listen to the reinvestigation and in-depth discussion of his case in season 2 of the incredible true crime podcastUndisclosed at http://undisclosed-podcast.com/episodes/season-2/, or at the Georgia Innocence Project’s active cases page at https://www.georgiainnocenceproject.org/active-cases-2/.

By Brandyn Arnold, CLS ’20

The First Circuit recently addressed the issue of whether people can be bound by an arbitration agreement of which they were not made aware. An advocacy group for the blind filed a lawsuit against the Container Store alleging that the company’s use of visual, touch screen point of sale devices constituted discrimination in violation of federal and state law. The Container Store sought to stay the proceedings, arguing that the customers agreed to arbitrate any disputes when they signed up for the company’s loyalty program. The First Circuit, with Justice David Souter sitting by designation, affirmed the district court’s decision to deny compelling arbitaration, finding that the customers never actually agreed to the arbitration clause. National Federation of the Blind v. The Container Store, Inc., No. 16-2112, 2018 WL 4378174 (1st Cir. Sept. 14, 2018).

The court begins its analysis by focusing on whether the issue of the arbitrations clause’s enforceability itself should have been resolved by an arbitrator. While the validity of an agreement as a whole should be determined by an arbitrator, a challenge to the formation of the arbitration clause can properly be considered by a court. Considering the challenge to the arbitration agreement to be based upon the contract principles of offer and acceptance, the court considers the issue to be whether there was the formation of a contract to arbitrate. Therefore, the court holds that the district court was an appropriate forum to resolve the issue of whether the customers agreed to arbitrate.

The court then examines whether the plaintiffs had adequate notice of the arbitration agreement to accept it. The court notes that no store clerk ever informed blind customers who signed up for the loyalty program that they were being subjected to an arbitration agreement. Nevertheless, the Container Store maintained that the customers actually had constructive notice of the clause’s existence by pointing out that the inability to read is not a defense to contract formation. However, the court found the cases relied on by the Container Store to be distinguishable because they involved situations in which the formation of legal rights and duties would be expected such as signing documents initiating loans or employment. Since the in-store customers had no reason to think that legal terms and conditions applied to the loyalty program, there was no presumption that the customers knew what these terms and conditions were. Accordingly, the customers had no actual or constructive knowledge of the arbitration clause’s existence and thus could not have agreed to be bound by its terms.

The case serves as a cautionary tale for both businesses and consumers alike. Businesses that want to avoid the costs of litigation by resolving disputes through arbitration should ensure that all customers are made fully aware of any arbitration agreement and thus have the capability of accepting it. In addition, a customer made aware of an arbitration agreement should fully consider the nature of the agreement and its ability to restrict the forum in which the customer’s grievances may be heard.

By Dani Parker, CLS ’20

On September 27, 2018, Dr. Christine Blasey Ford testified in front of the Senate Judiciary Committee that she had been sexually assaulted at a high-school party by then D.C. Circuit Judge and Supreme Court nominee, Brett Kavanaugh.[1]Dr. Ford was initially hesitant to testify front of the committee without a preceding FBI investigation, but she agreed to participate in a public hearing after Senate Republicans insisted upon continuing with the nominating process without her testimony.[2]This is not the first time assault allegations have surfaced amid Supreme Court nominations. In October 1991, Anita Hill testified in front of the Senate Judiciary Committee to sexual harassment by then Supreme Court Nominee Clarence Thomas.[3]

Allegations by Ms. Hill and Dr. Ford and the corresponding congressional hearings highlight the inadequacy of Senate procedures to appropriately account for sexual assault allegations that arise during the Supreme Court confirmation process. In this high-stakes context, such inadequate process may result in the appointment of individuals who are unsuited to sit on the nation’s highest court. As such, the Senate should employ research-based procedures for addressing sexual assault allegations that arise during the Supreme Court nomination process.

The Problem

Though its role is mostly customary, the modern Senate Judiciary Committee conducts pre-hearing investigations, holds public hearings, and makes a recommendation to the full Senate body.[4]While it normally conducts an extensive background investigation, there are no set guidelines for addressing the results of these efforts.[5]Typically, the Committee holds public hearings to discuss its investigative findings, but this practice results from custom and not rule.[6]Additionally, there are no rules governing what topics public hearings should concern.[7]Though politically unlikely, the Senate could complete the nomination process without formally considering or acknowledging sexual assault allegations.[8]

While the Judiciary Committee did choose to address such allegations during both the Kavanaugh and Thomas proceedings, the resulting publically televised hearings provided a hostile forum for serious consideration of the alleged victims’ claims. According to trauma research, neurobiological phenomena, “can affect the survivor’s ability to give a coherent, consistent account of their experiences.”[9]This is especially true when a significant amount of time exists between the alleged events and the victim’s testimony.[10]Both Dr. Ford and Ms. Hill came forward several years after their alleged assaults. Both sets of hearings pitted the testimony of the accuser against the word of the nominee and did not require additional investigation or testimony[11]. In both cases, televised hearings focused mainly on the words of the opposing parties and lacked an extensive standard for investigation. These methods place a scientifically inappropriate burden on the alleged victims’ memory, encouraging further political polarization instead of legitimate truth-finding.

Recommendation

To ensure comprehensive evaluation of Supreme Court nominees, the Senate Judiciary Committee should establish prescribed policies for addressing sexual assault nominations. In order to best facilitate truth-telling, these guidelines should be trauma-informed and should mandate research-based investigations. These requirements would facilitate appropriate due diligence on the part of the President and ensure that Senators would thoroughly consider the allegations before voting. While some may view this as too invasive, society should expect nothing less for the nomination process to our nation’s highest court.

[1]Scott Detrow and Danielle Kurtzleben, Kavanaugh and Christine Blasey Ford Testify Before Senate Judiciary Committee, N.P.R. All Things Considered (September 27, 2018),

https://www.npr.org/2018/09/27/652366140/kavanaugh-and-christine-blasey-ford-testify-before-senate-judiciary-committee

[2]Peter Baker et al., Christine Blasey Ford Wants F.B.I. to Investigate Kavanaugh Before She Testifies, N.Y. Times (September 18, 2018), https://nyti.ms/2NmMeZR.

[3]Elise Viebeck, Here’s what happened when Anita Hill testified against Clarence Thomas in 1991, Chicago Tribune (September 27, 2018), http://www.chicagotribune.com/news/nationworld/politics/ct-anita-hill-clarence-thomas-20180927-story.html.

[4]Barry J. McMillion, Supreme Court Appointment Process: Consideration by the Senate Judiciary Committee, Congressional Research Service Report (August 14, 2018), https://fas.org/sgp/crs/misc/R44236.pdf.

[5]Id.

[6]Id.

[7]Id.

[8]Id.

[9]Fiona Mason, Psychological Consequences of Sexual Assault, (2012), https://ac.els-cdn.com/S152169341200137X/1-s2.0-S152169341200137X-main.pdf?_tid=d4001a67-4cc1-4296-ac04-0d86dad97eea&acdnat=1538178437_a15324cf8da4dceb703153bbe2448280.

[10]Id.

[11]In fact, Anita Hill and Clarence Thomas’ testimonies popularized the phrase “he said, she said” in the context of “weighing the word of one defendant against the word of one plaintiff.” William Safire, On Language; He-Said, She Said, (April 12, 1998), https://www.nytimes.com/1998/04/12/magazine/on-language-he-said-she-said.html

By David Kellam, CLS ’19

Earlier this year, Congress voted to repeal the Federal Communications Commission’s (“FCC”) broadband privacy protections, allowing Internet service providers to sell our data.[1] As the market for our personal information continues to grow, service providers are not the only ones who are trying to convert our browsing history into a market commodity. In fact, major online services like Google and Facebook have been using and selling our data for years in order to make advertisements more specific to our online behavior.[2]   For instance, in 2015, Google began tracking people’s locations and structuring them in individual online portfolios known as “timelines.”[3] Anyone with access to your Google profile (millions of people get hacked per year) can see exactly where you go, when, and how frequently. In May of this year, Google announced that it would begin to tie credit card transactions to online behavior so that it can see how influential targeted advertising has been on people’s actual spending habits.[4]

While some argue that such invasions are innocuous or that they are merely making our online experience more personalized, others postulate that this era of data mining marks the end of human privacy as we know it.[5] While this may sound hyperbolic, it is certainly true that our understanding of privacy is changing. Although human privacy may not yet be lost in entirety, the convenience that is the supposed advantage of corporate data mining has a sinister side.   Last month, the stored data of millions of Instagram users was hacked and organized into a searchable spreadsheet allowing any victim’s contact information to be searched for $10.[6] Even healthcare organizations, the IRS, and Docusign have been the victims of hacking this year.[7] If Congress continues to broaden corporate latitude over our data, the risk of our personal information’s dissemination will grow, and the allegedly well-intentioned “personalization” of our online experience will have evolved into a frontal assault on our most private information.

[1] Thomas Fox-Brewster, Now Those Privacy Rules are Gone, This is How ISPs Will Actually Sell Your Privacy Data, Forbes (Mar. 30, 2017), https://www.forbes.com/sites/thomasbrewster/2017/03/30/fcc-privacy-rules-how-isps-will-actually-sell-your-data/#364af42a21d1.

[2] Chris Smith, Why Facebook and Google Mine Your Data, And Why There’s Nothing You Can Do To Stop It, BGR (Feb. 11, 2016), http://bgr.com/2016/02/11/why-facebook-and-google-mine-your-data-and-why-theres-nothing-you-can-do-to-stop-it/.

[3] Google Maps Now Allows You to Stalk Yourself Using Google Maps Timeline, Fossbytes (July 22, 2015), https://fossbytes.com/google-maps-stalk-yourself-using-google-maps-timeline/.

[4] Andrew Burt & Dan Greer, Opinion, The End of Privacy, N.Y. Times (Oct. 5, 2017), https://www.nytimes.com/2017/10/05/opinion/privacy-rights-security-breaches.html.

[5] Id.

[6] Casey Newton, An Instagram Hack Hit Millions of Accounts, and Victims’ Phone Numbers Are Now For Sale, The Verge, September 1, 2017, https://www.theverge.com/2017/9/1/16244304/instagram-hack-api-bug-doxagram-selena-gomez.

[7] Heidi Daitch, 2017 Data Breaches – The Worst So Far, Identity Force (Oct. 9, 2016), https://www.identityforce.com/blog/2017-data-breaches.

Sex, Drugs, and Commercial Speech: The Contested Discourse of Truvada

Joseph F. Lawless* 

* Farnsworth Note Competition Winner, 2016.  Ph.D. Candidate 2022, College of William & Mary, American Studies; J.D. Candidate 2017, Columbia Law School; B.A., University of Pennsylvania, 2012.  The author thanks Professor Noa Ben-Asher of Pace Law School for her thoughtful comments on prior drafts and for her wonderful encouragement; gratitude is also extended to Professor Bernard E. Harcourt and Professor Patricia J. Williams of Columbia Law School, both of whom remain faithful interlocutors and generous mentors.  Finally, the author offers the most heartfelt thanks to the editorial staff of the Journal of Law and Social Problems, with particular appreciation to Tara Raam, for their herculean efforts during the editing process.

In January 2016, Michael Weinstein, president of the AIDS Healthcare Foundation (AHF), a globally influential HIV/AIDS policy organization, urged the Food and Drug Administration (FDA) to take legal action against Gilead Sciences, manufacturer of the HIV-prophylactic medication Truvada, for violations of the Food, Drug, and Cosmetic Act (FDCA). The violations the letter enumerated were in reference to a Gilead-sponsored video advertising campaign that, per the allegations, misrepresented the proper usage regimen of Truvada. Under constitutional precedent governing commercial speech vis-à-vis pharmaceutical marketing, such misrepresentation of a drug’s constitutes “off-label” speech, a form of promotional advertising subject to criminal sanctions. This Comment explores the implications of AHF’s claims in the context of recent changes to commercial speech doctrine. It contends that should the FDA act upon the allegations contained in AHF’s letter it would require the agency to argue in favor of a significant misapplication of commercial-speech doctrine, particularly with regard to the branding provisions of the FDCA. Because the FDA continues to harden its stance on off-label use and speech, and in light of policy changes potentially encouraged by the new presidential administration, an examination of how the FDA might respond to allegations of FDCA violation is crucial. This Comment concludes by observing that the significance of this analysis is only heightened when the drug under legal scrutiny is one like Truvada — a prophylactic medication potentially able to drastically reduce the rate of HIV contraction if rendered more widely available.

I. INTRODUCTION

At the outset, we must determine whether the expression is protected by the First Amendment.  For commercial speech to come within that provision, it at least must concern lawful activity and not be misleading.  Next, we ask whether the asserted governmental interest is substantial.  If both inquiries yield positive answers, we must determine whether the regulation directly advances the governmental interest asserted, and whether it is not more extensive than is necessary to serve that interest.[fn id = “70”]

Although the district court in Washington Legal Foundation was, at the time of its decision, applying the full scope of jurisprudential precedent then available,[fn id = “71”] the Supreme Court has since intervened in the domain of commercial pharmaceutical communications.[fn id = “72”]  This intervention has resulted in a multilayered constitutional analysis that has been modeled by the Second Circuit Court of Appeals and a district court within its jurisdiction.[fn id = “73”]  These three cases — Sorrell v. IMS Health Inc., United States v. Caronia, and Amarin Pharma, Inc. v. FDA — illustrate the more robust analysis now expected of federal courts considering restrictions on commercial pharmaceutical speech.  Of importance in Sorrell was the Supreme Court’s articulation of the relationship between the First Amendment and pharmaceutical marketing: “[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.  As a consequence, [statutory restrictions on such speech] must be subjected to heightened judicial scrutiny.”[fn id = “74”]  This determination would undergird the reasoning articulated in both Caronia and Amarin and as well as propel a shift in the FDA’s regulatory regime in 2017.[fn id = “75”]

B. CONSTELLATING THE EFFECTS OF SORRELL IN THE SECOND CIRCUIT — UNITED STATES V. CARONIA AND AMARIN PHARMA, INC. V. U.S. FOOD & DRUG ADMINISTRATION

AHF’s letter alleges that Gilead’s video campaign, the contents of which will be discussed infra, misleads “viewers into believing that Truvada is safe and effective for use on a situational basis despite [Gilead’s] knowing that the drug is not approved for such use.”[fn id = “76”]  Such promotion, AHF argues, is proscribed by the FDCA.[fn id = “77”]  This question of the FDCA’s proscriptive jurisdiction was left unanswered in Sorrell, as the object of the Court’s consideration therein was the constitutionality of a state statute.[fn id = “78”]  However, in United States v. Caronia, the Second Circuit Court of Appeals addressed directly “whether . . . prosecution . . . under the FDCA only for promoting an FDA-approved drug for off-label use [could be] constitutionally permissible.”[fn id = “79”]  While the FDCA criminalizes misbranding or conspiring to misbrand a drug, the statute and its corresponding regulations do not explicitly proscribe off-label promotion.  Instead, 21 C.F.R. § 201.128, which addresses how a manufacturer’s intent may be evinced during a prosecution pursuant to the FDCA’s misbranding provisions, emphasizes an objective evaluation that “may, for example, be [buttressed] by labeling claims, advertising matter, or oral or written statements by such persons or their representatives.”[fn id = “80”]  Such analysis of the mens rea element of the misbranding offense necessarily implicates speech, which, as the Caronia court acknowledged, raises significant First Amendment concerns.[fn id = “81”]

Recognizing that construing the FDCA as criminalizing the mere promotion of a drug’s off-label use would pose a grave constitutional difficulty, the court offered a narrow interpretation of the statute as, pursuant to the doctrine of constitutional avoidance,[fn id = “82”] “not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.”[fn id = “83”]  The court began its analysis by considering the two-step inquiry articulated in Sorrell, wherein a court is first to consider “whether the government regulation restricting speech [is] content- and speaker-based”[fn id = “84”] and then “whether the government ha[s] shown that the restriction on speech [is] consistent with the First Amendment under the applicable level of heightened scrutiny.”[fn id = “85”]  Importantly, the Sorrell Court did not flesh out the contours of this “heightened scrutiny,” instead noting only that the state statute in question would be “unconstitutional even under the lesser intermediate standard set forth in Central Hudson.”[fn id = “86”]  Though the Supreme Court appeared to indicate that its abridged analysis could supplant the four-prong test developed in Central Hudson, the Caronia court offered an ordinal and merged interpretation of the doctrinal frameworks, beginning with Sorrell’s two-step inquiry to determine whether a constitutional violation based on viewpoint-discrimination exists and ending with Central Hudson’s less rigorous examination to consider whether the government can justify its criminal proscription of off-label promotion.[fn id = “87”]

A determination of content-based discrimination turns on whether the FDCA “distinguishes between ‘favored speech’ and ‘disfavored speech on the basis of the ideas or views expressed.’”[fn id = “88”]  Under the government’s proffered construction, speech about government-approved uses of drugs would be permissible while speech about off-label uses would necessarily remain prohibited, even if off-label use was not prohibited per se.  This interpretation would have the express purpose of diminishing “‘the effectiveness of [off-label drug] marketing by manufacturers,” strongly suggesting that the FDCA’s regulation of commercial speech was content-based and therefore presumptively unconstitutional.[fn id = “89”]  That this construction would effect speaker-based discrimination was facially manifest — as the court noted, “it targets one kind of speaker — pharmaceutical manufacturers — while allowing others to speak without restriction.”[fn id = “90”]  The court leveraged the Sorrell analysis to repudiate the government’s construction of the FDCA, and, after rejecting this reading of the statute, it turned to Central Hudson to determine whether the government could nevertheless pursue criminal sanctions under an alternative reading of the FDCA.  Insofar as the government’s position advocated the criminalization of off-label promotion, it could not be squared with its curious acquiescence in the dissemination of information regarding off-label use when requested by physicians;[fn id = “91”] accordingly, the court concluded that the government’s “criminal ban on off-label promotion by pharmaceutical manufacturers [was] more extensive than necessary to achieve [its] substantial interests.”[fn id = “92”]  The court ultimately construed the FDCA’s misbranding provisions “as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved drugs.”[fn id = “93”]

A year prior to the decision in Caronia, Amarin Corporation (Amarin), a biopharmaceutical company, sought FDA approval for a single use of Vascepa, a drug it had developed to address cardiovascular health issues.[fn id = “94”]  Subsequent to the FDA’s authorization of Vascepa’s intended use, Amarin sought in 2013 an additional approval for Vascepa to treat a derivatively related cardiovascular condition; the FDA, however, denied Amarin’s application, stating that the clinical trials Amarin conducted failed to yield sufficient data to support the medical benefits of this second usage.[fn id = “95”]  In response, Amarin stated that it wished at minimum to include the results of those clinical trials on Vascepa’s label to better ensure that physicians were aware of the drug’s positive indication for multiple cardiovascular conditions.[fn id = “96”]  In 2015, the FDA issued a letter refusing Amarin’s request and further stated that, should the company market Vascepa for any usage other than the one approved by the agency, the company would expose itself to criminal liability for “misbrand[ing] under the FDCA.”[fn id = “97”]  Ten days after FDA’s implicit threat of prosecution, Amarin filed a civil suit in the Southern District of New York, claiming that “FDA’s threat of a misbranding action [was] chilling it from engaging in constitutionally protected truthful speech”[fn id = “98”] and seeking “an injunction that would prohibit the FDA from bringing a misbranding action against [the company] for its truthful and non-misleading statements to doctors regarding Vascepa . . . .”[fn id = “99”]

In granting Amarin’s application for preliminary injunctive relief, the district court rooted its analysis squarely in the precedent set by Caronia.  In order to establish the intent (mens rea) and act (actus reus) elements of a misbranding action, the FDA argued at trial that it could “use Amarin’s statements regarding Vascepa’s [second usage] as objective evidence of Amarin’s intent to promote [Vascepa] for [an] off-label purpose” and cite any “truthful and non-misleading statements about that use” made by Amarin as evidence of the act of misbranding itself.[fn id = “100”]  However, the court noted that, “under Caronia, the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment.”[fn id = “101”]  The Caronia majority presented the issue as “whether a misbranding prosecution that identified a defendant’s speech alone as the proscribed conduct [could be] constitutionally permissible,” and the ensuing analysis held categorically that the FDCA’s misbranding provisions were not to be construed as reaching truthful speech promoting off-label use.[fn id = “102”]  Caronia is thus to be understood as a case of statutory construction that turned not on the mens rea requirement of the misbranding provision but rather on the actus reus requirement of that provision, and, because the court read the FDCA did not reach truthful, non-misleading speech promoting off-label uses, the FDA could not constitutionally pursue its threatened prosecution.[fn id = “103”]

IV. CONTESTING TRUVADA — CONSIDERING PHARMACEUTICAL SPEECH POST-CARONIA AND THE FDA’S NEW REGULATORY CALCULUS

A. A “BRAZEN NEW AD CAMPAIGN” — DETAILING THE CONTENT OF THE GILEAD-SUPPORTED VIDEO ADVERTISEMENTS

The AHF’s letter to the FDA regarding Gilead’s putative misbranding of Truvada, now written just over one year ago, has not yet incited a legal response from the agency.  Although the president of AHF, Michael Weinstein, addressed the letter to Stephen Ostroff, the then-Acting Commissioner of the FDA, there is no evidence the document was routed to the FDA’s Office of Prescription Drug Promotion (OPDP), the branch of the FDA charged with the review and surveillance of drug advertisement materials and thus the proper addressee.[fn id = “104”]  The FDA marshals the OPDP to run its “Bad Ad Program,” the purpose of which is “to increase the effectiveness of OPDP’s surveillance . . . especially with regard to curtailing inappropriate promotional activities” by allowing any individual to report misleading prescription-drug promotion.[fn id = “105”]  Assuming, arguendo, the AHF’s letter to the FDA can be taken as a form of reporting to the Program, the central investigative inquiry facing an OPDP reviewing officer would be whether the speech cited by AHF — three online videos, the production of which was financially supported by Gilead — encourage a use of Truvada inconsistent with the FDA’s approved usage.  A review of the videos produced for the advertising campaign is therefore useful in proceeding with the below analyses.

In total, Gilead appears to have sponsored the production of three videos by Public Health Solutions, a nonprofit organization based in New York City,[fn id = “106”] all of which addressed the question of whether Truvada was the right choice for an individual or a couple.  In the first video, an actor is seen collecting condoms and a small plastic bag of unidentifiable pills before heading out to a bar.[fn id = “107”]  The actor states that he “like[s] to party” while dancing at the bar.  In the following scene, he is seated at home, looking at his cellphone, which provides him with a reminder to take his daily dosage of Truvada.[fn id = “108”]  As the reminder appears on the screen, the actor states that he also “like[s] to be safe.”[fn id = “109”]  In the second video, a man is seen on his cellphone, facilitating a casual sexual encounter with another user of a cellphone application.[fn id = “110”]  After the two enter the man’s bedroom, he states to his paramour: “Hey . . .  I’m on PrEP.”[fn id = “111”]  When his partner admits to complete ignorance regarding Truvada, the man is shocked.[fn id = “112”]  The screen then cuts to a slide that offers a hyperlink for viewers to learn more about the medication.[fn id = “113”]  The third video is a series of crosscut interviews among several couples, all of whom are serodiscordant in HIV status.[fn id = “114”]  Each couple speaks about the multiple reasons why one might use Truvada or instead depend on condoms as the means of prophylaxis.[fn id = “115”]  One couple discusses the side effects of Truvada, after which an individual describes the three-month testing regimen for HIV status, as well as testing for kidney and liver health, that is medically necessary when taking Truvada.[fn id = “116”]  Perhaps most notable is when one member of a couple plainly states that he does not believe that Truvada is for everyone, as it requires an individual to have educated herself about HIV/‌AIDS and make the personal choice about what role she expects the medication to play in a serodiscordant relationship.[fn id = “117”]

B. THE VIABILITY OF AHF’S ALLEGATIONS AFTER CARONIA AND AMARIN

A determination of misbranding turns on a drug’s labeling; as mentioned, the FDCA defines “labeling” as “all labels and other written, printed, or graphic matter . . . accompanying [a drug].”[fn id = “118”]  At the outset, then, AHF’s linkage of the videos to Truvada’s labeling is legally sound.  Nevertheless, the primary allegation in AHF’s letter — that Gilead engaged in the purposeful misbranding of Truvada through Public Health Solutions’ video campaign — seems unsustainable upon a plain review of the three videos’ content.  In the letter’s concluding paragraph, AHF President Michael Weinstein characterizes the video campaign as misleading viewers into believing that Truvada “is safe and effective for use on a situational basis,” a point the letter earlier supports by reference to the content of the first video.[fn id = “119”]  The letter suggests that the small plastic bag the actor takes as he leaves his home contains recreational drugs, and, because the use of recreational drugs is assumed to be metonymic with a “cavalier attitude toward complying with the established PrEP regiment, consistent condom use, and regular testing,” the video necessarily “undermines the effectiveness of Truvada and expressly contradicts the approved usage of the drug.”[fn id = “120”]  While the suggestion that recreational drug use is integrated into certain sites of queer male culture is not without merit,[fn id = “121”] the chain of inferential reasoning the letter proposes is incoherent.  First, the conclusory statement that recreational drug use bears a relationship to an individual’s ability to adhere to a specific medical regimen is without support; second, the statement is intentionally written in bombastic fashion to veil the weaknesses of AHF’s legal arguments, which require the presence of misleading speech within the video and thus cannot be sustained.

As explained in Amarin, Caronia held that “the FDCA’s misbranding provisions cannot constitutionally criminalize, and therefore do not reach, the act of truthful and non-misleading speech promoting off-label use.”[fn id = “122”]  This conclusion necessarily followed from the Supreme Court’s prior observation that “[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment” and thus cannot be restricted absent a failure to satisfy the four parts of the Central Hudson analysis.[fn id = “123”]  AHF’s claim that Gilead promotes the situational use of Truvada as medicinally effective would, if before a court, likely be addressed under Central Hudson’s first prong, which queries whether the commercial speech under scrutiny is “more likely to deceive the public than inform it . . . .”[fn id = “124”]  The court in Caronia reiterated the axiom that “the First Amendment does not protect false or misleading commercial speech,” and the court’s construction of the FDCA affords no protection to the manufacturer who employs misleading communications in the promotion of an off-label use.[fn id = “125”]

The content of the first promotional video, though potentially referencing illegal substance use, certainly does not bind this provocative possibility to its representations of how Truvada is properly used.  The actor states that his enjoyment of socializing does not compromise his commitment to sexual safety, a message that the ringing of his cellphone’s daily reminder to take Truvada daily reiterates, a schedule clearly aligned with the medication’s prescription regimen.  Indeed, it may be that “partying” and “safety” are placed in such purposeful juxtaposition to demonstrate that the two are not irreconcilable — an individual can pursue autonomous sexual choices while remaining committed to bodily health and integrity.  Of equal consequence is that, in the context of the other two videos that constitute the advertising campaign, the messages presented in this first video appear intended to acknowledge the frank reality both of HIV/‌AIDS and of a strong desire to pursue enjoyment without sacrificing one’s sense of bodily care.

The crystallization of Caronia’s jurisprudential legacy as articulated in Amarin may have suffered partial erosion in mid-2016, when the Second Circuit Court of Appeals issued its decision in U.S. ex rel. Polansky v. Pfizer.[fn id = “126”]  The court there asserted in a footnote that its holding in Caronia, though having avoided the constitutional question presented by the FDCA’s potential implication of the First Amendment, had nevertheless “left open the government’s ability to prove misbranding on a theory that promotional speech provides evidence that a drug is intended for a use that is not included on the drug’s FDA-approved label.”[fn id = “127”]  A textual examination of Caronia, however, suggests that the court’s misrepresents the Caronia dicta.  The court in Caronia did not decide but rather assumed that a drug manufacturer’s promotional speech could be marshaled as evidence to prove that manufacturer’s intended use of a drug, a determination that would then support a criminal prosecution for mislabeling or misbranding.[fn id = “128”]  Although this difference in language is ostensibly minute, it effectively circumscribes the reach of Caronia’s holding.  Caronia is characterized as a case about simple promotional speech that does not seek to furtively supplant the particular use of a drug that the FDA specifically approved; this retrospective gloss once again opens the possibility of pharmaceutical marketing and speech to function as evidence of a criminal act.[fn id = “129”]

The essentially unanswered question of whether promotional speech may serve as the basis of a criminal prosecution or as partial evidence supporting a criminal prosecution leaves Gilead and, by necessary implication, Truvada in a precarious position.  Should AHF’s allegations be taken seriously, the nuanced rereading of Caronia in Polansky could allow the FDA to marshal the video campaign as a piece of criminalizing evidence — one of many that AHF has worked to compile and provide.[fn id = “130”]  Unsurprisingly, the FDA has taken notice of the jurisprudential ripples effected by Caronia.  In September 2015, the FDA issued a proposed rule that included amendments to the agency’s regulations regarding “intended uses.”[fn id = “131”]  In January 2017, the agency promulgated the rule in its final version, and the commentary accompanying the rule in the Federal Register offers useful insight into how the FDA will pursue misbranding allegations in the wake of Caronia.

C. POTENTIAL EFFECTS OF RECENT FDA RULEMAKING PROCEEDINGS AND THE JANUARY 2017 “INTENDED USES” FINAL RULE

In September 2015, the FDA initiated a rulemaking proceeding that had as one of its objectives the amendment of the agency’s “Intended Use” regulations.[fn id = “132”]  To better elucidate its position on the types of evidence that are permissibly considered in an intended-use determination, the agency then recommended the deletion of the final sentence of 21 C.F.R. § 201.128,[fn id = “133”] which stated:

But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.[fn id = “134”]

When first promulgated, the regulation sparked significant criticism from pharmaceutical companies because the final sentence, when literally read, appeared to hold that “a manufacturer’s mere knowledge of an unapproved use of its approved drug automatically triggers requirements for new labeling that in turn render distribution of that approved product unlawful . . . .”[fn id = “135”]  The FDA’s proposed deletion of that sentence intended to clarify that a manufacturer’s knowledge of physicians’ off-label use of a drug it had manufactured would not, by itself, trigger the FDCA’s labeling provisions.[fn id = “136”]  After reviewing the comments submitted in response to the proposed rule, the FDA ultimately decided to forego deletion of the sentence in favor of a detailed re-articulation that would “better reflect” how the agency has consistently applied its intended-use regulation.[fn id = “137”]  The final rule excised the former’s focus on manufacturer knowledge and articulated instead that an evaluation of “the totality of the evidence [can] establish[ ] that a manufacturer objectively intends that a drug . . . be used for conditions, purposes, or uses other than ones for which it is approved . . . .”[fn id = “138”]

Several comments to the proposed rule asserted that the FDA was constitutionally required to contract its proposed definition of “intended use” because of recent court rulings, including Caronia and Amarin.  The FDA’s response to these comments emphasized the agency’s express disagreement with “the assertion that the current case allow allows FDA to consider speech as evidence of intended use only when it is false or misleading,”[fn id = “139”] as articulated in Caronia.  The agency buttressed its claim with a citation to Polansky, quoting the language of the very same footnote that undermined the scope of the Caronia decision.[fn id = “140”]  Interestingly, after the Polansky court stated that Caronia left intact the government’s ability to prove misbranding through reliance on promotional speech as evidence, the court then cited the final sentence of 21 C.F.R. § 201.128, the FDA’s intended-use regulation, as analogous support for its argument.

The FDA’s citation to the Polansky footnote in its final rule curiously omitted any reference to court’s inclusion of the intended-use regulation — a somewhat glaring excision insofar as the agency altered the text of that very sentence.  The effect of Polanksy’s subtle circumscription of Caronia here becomes manifest, as the FDA was implicitly able to cite itself as judicial authority through its purposeful tailoring of the Polansky court’s footnoted text.  This reassertion of the evidentiary value of pharmaceutical speech further corrodes the protection afforded by Caronia.  Despite clearly addressing the constitutional complexities of off-label promotion throughout the text of the final rule, the FDA described the legal issues as sufficiently complex to merit a separate examination,[fn id = “141”] which the FDA initiated in September 2016.[fn id = “142”]

The newly altered version of 21 C.F.R. § 201.128 ostensibly provides some legal protection for drug manufacturers against discretionary enforcement actions for off-label promotion, but the FDA’s continuous equivocation in responses to comments on the rule’s proposed form suggests that the agency will not easily abandon its use of speech as prosecutorial evidence.  AHF’s assault on Truvada, though amenable to being categorized as politically reactionary, may function as an unexpected symbol of the entropic policy adjustments now characteristic of the current federal political climate.  Although the FDA took pains to describe its alteration of the intended-use regulation’s last sentence as a simple clarification of longstanding policy, a totality-of-the-evidence standard may, by virtue of the subjectivity involved in such an assessment, promote greater arbitrariness in the enforcement of FDCA prohibitions.  AHF is a powerful advocacy organization whose capacity to ignite unexpected sociopolitical change cannot be discredited,[fn id = “143”] and thus its sustained criticism of Truvada as the potential site of a second AIDS epidemic may tap into an internalized reservoir of AIDS-phobia potent enough to exploit the plasticity of the FDA’s purportedly “consistent” regulatory position.

V. OSSIFYING REGULATIONS OF OFF-LABEL SPEECH — CONCLUDING THOUGHTS ON THE IMPERILING OF TRUVADA AND COMMERCIAL SPEECH

On January 18, 2017, two days before the Trump administration took office and the regulatory ethos of the executive branch would begin to undergo substantive change, the FDA released an official agency document (entitled a “memorandum,” thereby reducing the scope of its regulatory significance to possibly nil) wherein it staked out its position on the First Amendment questions pertaining to off-label commercial speech.[fn id = “144”]  This document, which breaks years of agency silence on the specific question of the scope of First Amendment protection to which biopharmaceutical companies are entitled in the off-label marketing of approved drugs, suggests an attempt by the agency to place its views “on the record” before the change in administration results in an alternative approach; indeed, the memorandum may function to undercut the viability of any substantive change in the FDA’s position on off-label marketing, as significant changes in agency policy adversely affect the scope of deference afforded such changes.

The position the FDA articulates in its memorandum reflects the longstanding, implicit stance it has taken on off-label promotion: that the “government’s multi-faceted interests in the public health are substantial and . . . the relevant FDA Authorities directly advance many of those interests.”[fn id = “145”]  While it is certainly worthwhile to retain the rigorous standards of examination to which new medical drugs are subjected prior to their approval for placement within the national market, the FDA’s cursory dismissal of the legal questions addressed by the courts in Caronia and Amarin cast doubt on the FDA’s attempt at a reasonable, evidence-based analysis of the public-health concerns those cases raised.  The concern of heavily politicized bias within the domain of the FDA’s health policy determinations, augmented by the publication of the aforementioned Memorandum, led an organization of pharmaceutical companies and biotechnology corporations to file a petition to stay the implementation of the FDA’s Final Rule on intended use.[fn id = “146”]  According to the industry groups’ petition, the new standard the FDA will employ in its determination of a drug’s intended use, completed under a “totality of the evidence standard,” would allow anything to “be considered to establish a product’s intended use,”[fn id = “147”] thereby allowing the FDA “to rely even on non-promotional scientific exchange as evidence of intended use.”[fn id = “148”]  The chilling effect of such a standard is difficult to comprehensively imagine, as any kind of speech a pharmaceutical corporation engages in could be marshaled as evidence that the firm intended to misrepresent the manner in which the drug is approved to be used.

This new standard and the recalcitrance of the FDA to offer a more nuanced position on the relationship between the rights the First Amendment protects and the effects of those rights on commercial speech must be considered in contexts beyond those to which the FDA blithely alludes, such as those in which biopharmaceutical corporations seek the First Amendment as a shield to veil their exploitative efforts.[fn id = “149”]  A medication such as Truvada, which serves communities subject to multiple forms of social disqualification, is particularly vulnerable to the kind of attacks the FDA’s policy would allow — a concern that is undoubtedly aggravated in the new political context portended by the Trump administration.  The question here is thus not whether the FDA should or should not relax its standards regarding the proliferation of off-label speech; rather, it is whether the broad stroke the current policy effects may prove hazardous to continued access to drugs capable of changing the destruction experienced by communities that remain vulnerable to systemic exposure to illness and disease.  Further, this question must consider whether the FDA’s position may offer the new administration a sword against which to assault those biopharmaceutical companies not engaged in off-label speech, as conventionally envisioned, but engaged in providing medication and information to communities otherwise imperiled by lack of access to medical information and drug availability.