Symposium Agenda – Right to Try Laws: The Benefits and Burdens

The 2019 Fall Symposium is right around the corner; check out our schedule of speakers and learn more about their backgrounds below.

November 1, 2019

9:15-9:45am—Breakfast and Registration

9:45-9:50am—Welcome by Dean Jane Aiken, Assoc. Dean Jonathan Cardi, Chris Coughlin & Melissa Temple Malone

9:50am-10:20am—Setting the Stage: Fifty Years of End-of-Life Care Debates

by Dr. John Moskop, Wake Forest University School of Medicine

Moderator:  Dr. Pat Lord, Wake Forest University, Department of Biology

10:25-10:55am—Keynote: Informed Consent in Right to Try:  A Dubious Assumption by Professor Rebecca Dresser, Daniel Noyes Kirby Professor Law Emeritus, Washington University in Saint Louis School of Law

Moderator:  Prof. Mark Hall, Director of the Wake Forest Health Law and Policy Program, Fred D. & Elizabeth L. Turnage Professor of Law

11:00-11:45am—Panel Discussion: Right to Try Issues in Pediatric Medicine and GeneticsDr. Ana Iltis, Professor, Carlson Professor of University Studies, Philosophy; Director, Center for Bioethics, Health and Society, Dr. Michael Kappelman ; Dr. Sumy Joseph

Moderator:  Wake Forest 2L, Madison Alligood, Wake Forest Journal of Law & Policy

11:50-12:25pm—Performable Case Study and Discussion on Pediatrics, Genetics, and the Right to Try by Prof. Richard Robeson, Wake Forest University, Communication and Center for Bioethics, Health & Society; and various members of the Wake Forest School of Law Journal of Law and Policy

Moderator:  Prof. Steve Friedland, Elon University School of Law

12:30-1:30pm—Lunch

1:30-2:05 pm— Perspectives on the Role of the Patient Advocate in FDA Regulation by Prof. Jordan Paradise, Georgia Reithal Professor of Law, Loyola University of Chicago School of Law

Moderator:  Prof. Bethany Corbin, Director of the Wake Forest Master of the Study in Law Program, LLM Health Law, Loyola University of Chicago School of Law

2:10-2:40—Payment Models for Access to Unapproved Drugs by Prof. Christopher Robertson, Associate Dean for Research and Innovation, University of Arizona, James E. Rogers College of Law

Moderator:  Professor Simone Rose, Associate Dean for Innovation and Entrepreneurship, Wake Forest University School of Law

2:45-3:25 pm—Panel Discussion: The Terms of Trying by Professor Nancy M. P. King, JD. Professor, Department of Social Sciences & Health Policy and Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine; Co-Director, Center for Bioethics, Health, & Society and Graduate Program in Bioethics, Wake Forest University, & William Zoffer, JD, industry consultant, former Senior Vice President, U.S. Pharmaceuticals Legal Operations, GlaxoSmithKline and U.S. Department of Justice

Moderator: Suzanne F. Cook, Ph.D, Principal, Epidemiology Associates, LLC 

3:30-4:00—The Right to Try Debate by Wake Forest University Debate Team—consistently ranked one of the top debate teams in the country, the students will be performing a debate that will bring out many of the different arguments relevant to the Right to Try debate.  

4:00 pm—Closing by Prof. Chris Coughlin & Melissa Temple Malone

All registrants will receive a link to the footage from the event whether or not they are able to attend; register now!

Interpreting Signals from Chief Justice Roberts

Adam McCoy

Chief Justice John Roberts has received relentless attention lately as the new potential swing vote on the United States Supreme Court. The entire legal community is looking for indications on how he will rule on a variety of legal issues. The Court has yet to take up many of the most controversial potential issues, however recent decisions do give some indication of how Chief Justice Roberts may guide the Court for the foreseeable future.

Chief Justice Roberts has recently used his vote and opinions to make clear to the legal world that the Supreme Court itself holds the unique authority to overturn precedent from the nation’s highest Court. In June Medical Services v. GeeLouisiana had recently passed a law, which the Fifth Circuit upheld, requiring abortion providers to have admitting privileges at a hospital within thirty miles of where the abortion is provided. This law is identical to the law the Supreme Court struck down as unconstitutional in Whole Woman’s Health v. Hellerstedt by finding it placed an undue burden on the woman’s right to an abortion. Chief Justice Roberts dissented in Hellerstedt, however when Louisiana passed a law in direct contradiction to that existing precedent, he still granted an injunction to stop implementation of the law. Even if Chief Justice Roberts would prefer the law was different than Hellerstedt, his vote in June Medical Services shows he will likely not let states and lower courts contradict precedent on their own.

Chief Justice Roberts underscored his insistence lower courts follow all Supreme Court precedent by siding with the liberal leaning justices to stay the execution of Bobby Moore in Moore v. Texas. Again, the Chief Justice dissented in the earlier case, which stayed Moore’s execution in 2017 and remanded to the Texas court with instructions on how to evaluate Moore’s intellectual disability. However, when Moore’s case returned to the Supreme Court, he switched his vote and agreed to stay the execution. Specifically, Chief Justice Roberts said the Texas Court of Appeals “misapplied” the Court’s previous opinion.[1] The Texas court “repeated the same errors that [the] Court previously condemned—if not quite in haec verba, certainly in substance.”[2] Chief Justice Roberts had dissented from that previous condemnation of errors, however when the lower court ignored that order from the Court, he switched his vote to force lower courts to abide by existing Supreme Court precedent.

The importance of precedence was reemphasized in Madison v. Alabama, by Chief Justice Roberts joining the opinion of Justice Elena Kagan holding the death penalty unconstitutional when dementia prevents the prisoner from understanding the state’s reason for the execution. Again, the Chief Justice provided the decisive fifth vote by joining with the liberal leaning members of the Court. Justice Kagan grounded her opinion in the Court’s previous decision in Panetti v. Quarterman, which held the Eighth Amendment prohibits executing a prisoner whose psychotic delusions prevents them from understanding the state’s reason for the execution. Chief Justice Roberts dissented from Panetti and disagreed with the Court’s conclusion if the prisoner did not understand the reason for the execution then the execution had no retributive value. 

However, in Madison he provided the decisive fifth vote for Justice Kagan to expand the precedent of Panetti to include prohibiting execution when memory loss is the reason the prisoner cannot understand the reason for the execution. Justice Kagan said the logic from Panetti focused on whether the mental defect, in this case memory loss, had the effect of creating “an inability to rationally understand why the State is seeking execution,” and when that understanding is missing the prisoner cannot be executed.[3] Chief Justice Roberts supported treating this precedent as controlling and using it to decide Madison, despite the fact he dissented in the original case.

These recent decisions indicate that respect for precedent will play a critical role in how Chief Justice Roberts leads the Court in the coming years. Even if the Chief Justice dissented in an earlier case, he will not simply treat that decision as illegitimate, but will require the Court to operate under the acknowledgment of that precedent. Additionally, Chief Justice Roberts has sent the message that states and lower courts must respect all precedent from the Supreme Court, and only the Court can change its own precedent. Chief Justice Roberts is making it clear that acknowledgment and respect for precedent will play a necessary role in how he evaluates future cases and how he eventually decides to cast his possibly deciding vote.  


[1]Moore v. Texas, 586 U.S. ___, ___ (2019) (Roberts, C.J., concurring) (slip op. at 1).

[2]Id.

[3]Madison v. Alabama, 586 U.S. ___, ___ (2019) (slip op. at 12).

Constitutional Standing in the Latest Individual Mandate Decision

Constitutional Standing in the Latest Individual Mandate Decision

Daniel Becker

The Affordable Care Act’s individual mandate has been a source of continued trouble for the law. NFIB v. Sebelius found that that the individual mandate was constitutional, but only if the Court recast the individual mandate’s penalties as a tax. The Republican Congress then zeroed out that tax with the passage of the Tax Cuts and Jobs Act of 2017. Finally, on December 14, 2018, the Northern District of Texas found the individual mandate unconstitutional and inseverable from the rest of the law, causing the Judge to find the entire Affordable Care Act unconstitutional. While other authors have discussed some of the odder features of this opinion, this particular article will focus solely on the opinion’s analysis of the individual plaintiffs’ standing. Those plaintiffs may not have met the constitutional standing requirements and, consequently, should have had their case dismissed.

The district court states the three elements of Constitutional standing: 1) there must be a concrete, particularized injury; 2) that is traceable to the defendant’s conduct; and 3) the court’s decision can redress the injury. In this case, the plaintiffs claimed they had a choice between purchasing health insurance or paying a tax. Without that choice, they would not have purchased health insurance at all. Thus, the court found that the plaintiffs were objects of a regulation, the individual mandate, which gave them standing to challenge the mandate. However, the court’s analysis here seems incorrect. The plaintiffs appear to have failed two aspects of the standing requirements: the plaintiff’s injury is not traceable to the defendant’s conduct, and the court is unable to redress the injury.

First, the plaintiff’s injury is not traceable to the defendant’s conduct. As the district court states, an object of regulation normally has standing to challenge a regulation because the injury is directly traceable to the government’s regulation. In other cases—including the one the court cites—the failure to comply with a regulation results in penalties. In that cited case, Contender Farms, LLP v. USDA, the plaintiffs were subject to penalties if they did not comply with the USDA regulations on horse soring. Those penalties included suspension from Horse Industry Organizations (HIOs) and the imposition of mandatory minimum fines for violations of the USDA’s regulation. Here, it is not clear what the plaintiff’s penalties were because the penalty for failing to purchase health insurance was a tax of zero dollars. While the court notes that a showing of economic injury is not required for plaintiffs to succeed, there is little evidence of any other injury. Plaintiffs allege the regulation creates a burden on their constitutional rights, but the court never explains how the plaintiffs’ constitutional rights were burdened through a regulation that carries no penalties.[1]

Second, and closely related, the district court’s decision does not relieve the plaintiffs from their alleged injury. Typically, redressability of a regulatory injury is easily foreseeable. The plaintiffs are currently subject to a regulatory burden. If the court finds the regulation illegal or unconstitutional, would the plaintiffs’ injury be redressed? If yes, then the redressability prong is met. If not, the plaintiffs lack standing. Here, the court found that declaring the individual mandate unconstitutional would redress the individual plaintiffs’ injuries. This redress includes allowing the individuals to forego purchasing health insurance altogether, which they were always free to do, or purchase health insurance below the government-set minimum standard. Yet, eliminating the minimum standard would not necessarily result in health insurance offerings below that standard. It is just as possible that health insurance would still be offered at or above that standard because so few people would purchase what they consider substandard health insurance, even in the absence of government enforcement.

The district court’s reluctance to make policy is well-founded. An equally applicable canon is to avoid constitutional questions where possible. The court may have had an opportunity to avoid making policy by looking closely at standing and finding the plaintiffs had none. Though the court did not take that opportunity, it may arise again when the case is appealed to the Fifth Circuit.


[1] Note that this could also mean the plaintiffs did not adequately plead their non-economic injury, which could raise Twombly pleading issues. The Court cannot give relief if the plaintiffs did not adequately plead their injury.

Legal Loophole or Vital Protection: Does Removing Safeguards for Migrant Children Go Too Far?

Legal Loophole or Vital Protection: Does Removing Safeguards for Migrant Children Go Too Far?

Victoria Grieshammer

Of the many controversies of Trump’s presidency, the separation of children from their parents during the immigration process may be one of the most acrimonious. Indeed, regardless of one’s politics, it is difficult to think of a more distasteful situation than one where parents and children are wrenched from each other by the government. This is made worse by the fact that this happens during such a stressful event as moving to a new country, especially when such moves are often the result of violence and poverty in one’s home country. The conditions in which the children are kept do not help to ease these harrowing events. These tent cities, as some have called them, do not provide schooling, books or mental health treatment, temperatures can reach up to 100 degrees, and children are there for months, uncertain of their futures.

The crisis has only gotten worse, as hundreds of children have been held in these tent cities for months. Specifically, more than 500 children have been in a tent city near Tornillo, Texas since August. Additionally, another 46 children have been held at that site since June. Aside from the clear abuse of human dignity as well as a public relations disaster, this also violates a two-decades-old court order on the length that minors can be detained. This 1997 court settlement—frequently called the Flores agreement—came out of the Supreme Court case Flores v. Reno. Perhaps unsurprisingly, the agreement originates from previous alleged mistreatment of migrant children by the former Immigration and Naturalization Service in the 1980s. Specifically, Jenny Flores, for whom the case is named, was detained at age 15 while crossing the border to live with her aunt. After being apprehended, the 15-year-old was arrested, placed in handcuffs, and strip-searched, all while her aunt was denied custody and Flores was kept in a juvenile detention center.

The Flores agreement requires U.S. authorities to move immigrant children out of the detention centers and into state-licensed shelters, or to parents or guardians, within 20 days. When the families are released together, they are often given GPS ankle bracelets to track their whereabouts until it is their time to go to court. As might be expected, Tornillo, the tent city in question, is not one of these state-licensed shelters. The difference between state-licensed shelters and those like Tornillo is in more than just their titles. Indeed, these state-licensed shelters have such important features as access to schooling and legal counsel. Accordingly, migrant children are being held in these facilities in violation of long-standing precedent that was erected to ensure their health and safety.

This single violation of the Flores agreement is the tip of the iceberg, though. In fact, the Trump administration is in the process of gutting the protections provided by the Flores agreement. Although Trump has stated that he will replace the rule with a similar one that ensures immigrant children are “treated with dignity, respect and special concern for their particular vulnerability,” it is currently unclear how this will look in actuality. To replace the families’ ability to leave the shelters, the administration asserts that it will build more humane shelters that will house migrants for longer. The administration’s reasoning for eliminating the so-called legal loophole is that the Flores agreement may have the effect of enticing immigrant families to come to the United States with the idea that their children will keep them from being held in detention centers for extended periods of time. This claim is unsubstantiated, though, and is even possibly refuted by data that shows that unauthorized Mexico border crossings have actually significantly declined since the Flores agreement. If the comments on this rule are any indication, the public does not approve. Whether the revising of the Flores settlement agreement will continue to protect migrant children or whether immigration services will continue to repeat mistakes of the past, though, is left to be seen.

Jaded and Confused: FASORP’s Title VI and Title IX Lawsuits Against Harvard Law Review

Jaded and Confused:
FASORP’s Title VI and Title IX Lawsuits Against Harvard Law Review

Elizabeth Grindell

On October 6, 2018, a Texas law firm filed a lawsuit on behalf of the group, Faculty, Alumni, and Students Opposed to Racial Preferences (FASORP)[1] against Harvard Law Review, alleging violations of Title VI and Title IX. FASORP claims that the Law Review commits illegal race and sex discrimination when selecting articles for publication by giving preference to articles written by women or racial minorities. The practice of considering race and sex for opportunities in the field of higher education was established based on long-standing, historic evidence of invidious discrimination against women and minorities; yet FASORP seems to overlook the benefit that Harvard’s Law Review gains from such diversity. Selecting authors with varied backgrounds and life experiences directly caters to the Law Review’s vital goals of introducing original and nuanced perspectives into legal academia by encouraging unique topic selection and creative avenues of investigation into modern theories and issues of the law.

The Harvard Law Review chooses 18 of its 48 new editors through a holistic evaluation in which applicants can indicate their race, ethnicity, gender, sexual orientation, socioeconomic status, and any physical disabilities. Compl. ¶¶ 14–16. FASORP alleges that“this ‘holistic’ evaluation gives preferential treatment to women, ‘underrepresented’ racial minorities, homosexuals, and transgendered people . . . at the expense of articles written by FASORP members who are white or male.” Compl. ¶ 17. FASORP goes even further, however, calling the Law Review’s members and editors “less capable students” due to this selection based on diversity criteria as opposed to solely merit-based considerations.[2] FASORP additionally claims that alumni of the Harvard Law Review also face injuries because of these practices, in that “race and sex preferences [] diminish the prestige of the law review credential,”citing a 1995 article by Richard A. Posner which cautioned that Harvard’s “epicycles of affirmative action” would make it a “laughingstock” in the future. Compl. ¶ 28.

FASORP’s mission creates tension between the class of students and alumni accustomed to privilege that sees diversity practices as a detraction from their own successes, and the class of current students and editors who are receiving the benefits of these programs in a way that prior generations have been historically denied. In an effort to mitigate the former class’ jaded assessment of holistic evaluations, FASORP resorts to the overused motif of women- and minority-protective arguments to bolster its position. For example, FASORP asserts that Harvard’s holistic evaluations injure women and minorities as well because “it is difficult or impossible for them to prove that they earned their law-review membership because of academic merit rather than the Law Review’s diversity set-asides.” Compl. ¶ 29. According to FASORP, because of this practice “their law-review membership [is] tainted . . .” Compl. ¶ 31. To interpret these allegations in any way other than demeaning and irresponsible is to reaffirm the necessity of women’s and minorities’ participation in academic discourse of the very kind Law Reviews and Journals seek to instigate; for without their perspectives and voice, attitudes like FASORP’s become pervasive and malignant. I think what this lawsuit truly comes down to is this well-known progressive expression: When you are accustomed to privilege, true equality feels a lot like oppression.

 

[1] According to Bloomberg, FASORP’s website domain was created on October 6th of this year—the same day that the Harvard suit was filed. Bob Van Voris, Harvard Law Review Suit Opens New Front in Admissions-Bias Fight, Bloomberg (Oct. 8, 2018), https://www.bloomberg.com/news/articles/2018-10-08/harvard-law-review-suit-opens-new-front-in-admissions-bias-fight. On FASORP’s site, fasorp.org, the group expresses its “opposition to the corrupt and discriminatory practices that subordinate academic merit to diversity considerations.” It features a submission box giving visitors to the site, including non-members and anonymous users, an opportunity to submit “evidence” or “anecdotes” including “incriminating e-mails, audio recordings, and documents that expose race or sex preferences.”

[2] Compl. ¶ 26 (“Because the Harvard Law Review has subordinated academic merit to diversity considerations when selecting its members and editors, the articles that FASORP members submit to the Law Review are judged by less capable students—and these are the students who will ultimately make the career-altering decision of whether a professor’s article gets accepted for publication or rejected.”).

Inadvertent Lessons from Judge Kavanaugh’s Confirmation Hearing

Inadvertent Lessons from Judge Kavanaugh’s Confirmation Hearing

Heather Stinson

As the confirmation hearings for Supreme Court nominee, Judge Brett Kavanaugh, continue to heat up, with now three women coming forward proclaiming that there is a side to Judge Kavanaugh that should be known by the Senate Judiciary Committee before a vote as to whether he should be promoted to the highest Court, I am struck by two unrelated concerns.

First, is this notion that a person is only capable of being one version of themselves at all times, in all places, with all types of people. Many who have known Judge Kavanaugh in various capacities over the years have made statements or submitted signatures vouching for him, since in their experience they never witnessed any behavior that would give them pause or concern. In my previous role with the Independent Reconciliation Compensation Program (“IRCP”), which is tasked with compensating victims of childhood sexual abuse by clergy covering five different Diocese in New York, I learned quickly that people are in fact capable of being more than one type of person. Certainly, those who were victims of clergy sexual abuse also learned this lesson when they witnessed their abusers lovingly administering mass on Sunday after having raped them the night before. Many of those same victims were not believed because their families and friends in the parish could not square their good interactions with the parish priest with the allegations of abuse being lodged. Thus, we must dispense with the notion that Judge Kavanaugh, or any person for that matter, is only ever always good or always bad in behavior. After all, not even the vilest pedophile priest was abusive to all children in a parish, to some he was the embodiment of God himself. How can you get much better than that?

Second, is this idea that a man, giving a woman a job, is the definition of a woman’s rights supporter, and thus the inference goes, someone who would then be incapable of otherwise harming a woman—which has been raised as Judge Kavanaugh and his supporters push back on the allegations of possible sexual assault. Judge Kavanaugh has made a point, both in an interview and other statements, to praise his own record for how many female law clerks he has previously hired and later recommended to clerkships on the Supreme Court. It genuinely concerns me that women have a harder time obtaining certain caliber clerkships, even though women make up the majority of law students. Mostly though, when Judge Kavanaugh pats himself on the back for being so willing to hire women, to me it is as if he is admitting that he could have gotten away with not hiring women, or at least not so many women. So as these previous clerks vouch for him as a person who, based on their working relationship with him (which, it should go without saying, is not the context that is at question with the allegations) is incapable of sexually assaulting a woman, they are also admitting that they owe their careers to the benevolence of a man. It should concern the entire legal profession that for women, it is still men who are making or breaking their careers. Women obviously need both male and female mentors, and as such I don’t discount Judge Kavanaugh’s intention in hiring and mentoring women. Rather, I take issue both with the idea that a logical inference from his propensity to hire females is that he would be incapable of inappropriate behavior towards a woman in any context, and with the inadvertent admission that the legal profession is still a boy’s club, either because it is the boy who gets the job, or because it is the boy who graciously bestows the job to the girl.

As for the allegations themselves, my hope is that all involved, including Judge Kavanaugh, receive proper support and a fair hearing. Let us focus on what matters and dispense with distracting and erroneous ideas, such as the idea that a person is only ever all good or all bad. The purposes of the allegations being brought forward are to attest to the character and ability of a judicial nominee, period. If true, these allegations point to a side of Judge Kavanaugh that may disqualify him for this particular job. There are so few people who will ever sit in one of those nine seats it behooves us to make sure we ascertain all we need to know about a nominee before handing over that chair.

The Supreme Court Can Fix Qualified Immunity

The Supreme Court Can Fix Qualified Immunity

Daniel Becker

The doctrine of qualified immunity has come under increasing scrutiny. While Justice Sotomayor has led the charge for reform at the Supreme Court level, lower federal courts have begun to call for a reevaluation of the doctrine. One court called the current application of qualified immunity “overprotective of police and at odds with the original purpose of section 1983.” On the Fifth Circuit, Judge Willett criticized “the kudzu-like creep of the modern immunity regime.” Critics point out that qualified immunity is extremely difficult for plaintiffs to surmount, which often results in no remedy being granted for violations of a plaintiff’s rights. Two simple tweaks to qualified immunity may be able to bring the doctrine back to its roots and allow the validation of violated rights.

Courts apply a two-part test to determine whether an officer is entitled to a grant of qualified immunity. The first part of the test asks whether the officer’s conduct violated a constitutional right. The second part of the test is to determine whether the law was clearly established at the time such that the officer should have known that the conduct was unlawful. The purpose of qualified immunity is to protect officers when they act in tense situations where the law has not provided clear guidelines. Thus, qualified immunity is granted unless the officer violated a clear constitutional right and the officer’s conduct was clearly established as unlawful at the time of the incident.

Ideally, a growing body of case law would establish what conduct violates constitutional rights and would slowly eliminate the gray areas in the law. This, however, is not the case. The Supreme Court does not mandate that courts answer whether a constitutional right was violated. Courts often find it easier to decide that the law was not clearly established in a given case, instead of first finding that the conduct was a constitutional violation and then finding that it was not clearly established. Thus, the growing body of case law, which would gradually eliminate some of the legal gray areas around constitutional violations, never grows. This is precisely the point Judge Willett made in his concurrence. Avoiding the first test necessarily forces the stagnation of the second test because the law will never be clearly established. To fix this stagnation problem, the Supreme Court can mandate that lower courts apply both prongs of the test to all cases, which they were required to do from 2001 until 2009.

Another potential solution to the difficulty of prevailing on a claim that constitutional rights have been violated is for the Supreme Court to restore the ability of courts to examine the intent of the officer. This would move the qualified immunity from an objective analysis based on what a reasonable officer would do to a subjective analysis based on the officer’s intent when he performed an action. For example, the Supreme Court sustained a qualified immunity defense where an officer killed the driver of a fleeing car. The car was about to hit a spike strip when the officer opened fire. The officer would later tell his superior officer “How’s that for proactive?” Because qualified immunity is an objective analysis, these words could not be used in the Court’s legal analysis. Under a subjective analysis, however, those words could show the reckless disregard the officer had for the law and thereby bar him from successfully asserting qualified immunity.

Qualified immunity is an important doctrine. It tries to balance the interests of officers in performing their duty without fear of legal consequence, the interests of citizens in the protection of their constitutional rights, and the interests of society in law enforcement and protection from crime. The courts increasingly appear to have skewed that balance in favor of law enforcement. Spurring the growth of a body of case law to establish when conduct violates the constitution and allowing courts to look at the subjective intentions of officers would go a long way toward fixing the doctrine.