In 2012, a Jane Doe suspected of transporting drugs was detained by U.S. Customs and Border Protection (CBP) agents without a warrant, and brought to University Medical Center in El Paso, Texas. Medical Center personnel — under the direction of the law enforcement agents — performed an X-ray, CT scan, and cavity search before determining that the woman was not in fact carrying any controlled substances. A few months after suffering this traumatic — and possibly illegal — event, the woman received a $5400 bill from the Medical Center for the services rendered as part of the search.
While the woman was compensated to some extent — she settled lawsuits with University Medical Center and the CBP to the tune of $1.1 million and $475,000, respectively — her story, and stories like hers, raise important questions about the ways in which hospitals should (or shouldn’t) work with law enforcement to perform invasive searches.
It’s understandable why hospitals and medical professionals are inclined to cooperate with law enforcement requests for invasive procedures and cavity searches — law-abiding citizens often don’t want to obstruct law enforcement agents from doing their jobs. But in the course of bringing suit against University Medical Center, Edgar Saldivar of the ACLU of Texas noted that the hospital and many of its personnel didn’t know where the obligation to assist the CBP stopped. Many medical professional don’t know that — according to the CBP’s own Personal Search Handbook — they are under absolutely no obligation to comply with requests by law enforcement to perform cavity searches with or without a warrant.
In a recent post, I explained the contours of the False Claims Act (FCA) implied certification theory of falsity, the subject of the recent Supreme Court argument in Universal Health Services v. United States(UHS). In this post, I will address an issue largely overlooked by most commentators: the potential for differing interpretations of what is required by the underlying Medicare and Medicaid provisions that form the basis for the certification.
Recent years have seen an expansion of FCA cases from “factually false” misrepresentations to those involving “legally false” claims, where items or services were provided but the claimant also violated an underlying legal requirement. For example, UHS involves an allegation that the defendant clinic violated the FCA because, by submitting a claim for payment under MassHealth, it implicitly certified that it was in compliance with all relevant Massachusetts regulations – including the staffing and supervision requirements it later was found to have violated.
Courts have taken two broad approaches to defining the universe of regulatory provisions with which certification will be implied. Some courts, notably the Second Circuit in Mikes v. Straus, 274 F.3d 687 (2d Cir. 2001), limit the theory to violations of statutes or regulations clearly identified as conditionsof payment. Other courts, such as the First Circuit in UHS, instead ask whether the claimant “knowingly represented compliance with a material precondition of payment,” which need not be “expressly designated.” The tests may sound similar, but differ both theoretically and functionally. First, defining implied certification by reference to “materiality” is curious in light of the fact that, since 2009, materiality has been an express – and distinct – element of the FCA false records provision in 31 US.C. § 3729(a)(1)(B). Yet implied certification cases such as UHS usually arise under the false claims provision in § 3729(a)(1)(A), which Congress did not amend to require materiality.
Sometimes, we lie when we speak; other times, we lie when we don’t. Striking the right balance is the essence of the Universal Health Services (UHS) case recently argued before the Supreme Court, which challenged the applicability of the False Claims Act (FCA) to situations in which a claimant falsely “implies” compliance with underlying regulatory requirements.
UHS was brought by the parents of a young woman who died after receiving Medicaid-covered (MassHealth) mental health treatment from a clinic that did not satisfy state licensing and supervision regulations. The parents alleged that the claims for payment were fraudulent because they implicitly represented that the clinic was in full compliance with relevant state requirements. The district court dismissed the suit, finding that the staffing and supervision regulations were not “conditions of payment” whose violation would render subsequent claims false under the FCA. The First Circuit reversed, focusing instead on whether UHS had “knowingly represented compliance with a material precondition of payment.” Noting that preconditions need not be “expressly designated,” the court identified a set of regulations that, read together, appeared to limit MassHealth payment to properly supervised care. While such a fact-intensive dispute might at first appear an unlikely candidate for certiorari, UHS was one of several such “implied certification” opinions issued by the federal appellate courts in 2015. Perhaps because of its emotionally compelling facts – the other cases involved, inter alia, the recruitment practices of a for-profit college and a military contractor that falsified marksmanship scores – UHS was chosen as the vehicle to resolve a growing circuit split. Continue reading →
On Monday, Governor Terry McAuliffe of Virginia proposed a significant change to the Virginia legislature’s bill to replace lethal injection with electrocution in death penalty cases. Instead of allowing electrocution, the amendment would give greater authority to the Department of Corrections (DOC) for procuring and making lethal injection drugs. Under the proposed amendments, the DOC could contract with a pharmacy to compound drugs necessary to carry out lethal injection. The amendments would also keep the names of drug suppliers and compounders secret by exempting the information from the Freedom of Information Act. Also, the names would not be discoverable “in any civil proceeding unless good cause is shown.”
States with capital punishment are increasingly resorting to state secrecy laws as they are finding it harder to procure the lethal injection drugs they need. At least fourteen states have passed or tried to pass rules keeping the names of lethal injection suppliers confidential. Some states, such as Georgia, define information about the drugs and equipment used in an execution as a “confidential state secret” so that the public prisoners and even courts are prevented from viewing the information. Other states, including Oklahoma, do not designate this information as a state secret but nonetheless, make the information unavailable through litigation. A few states allow litigants to discover the information through litigation, but the state does not need to make the information publicly available.
Marijuana and marijuana-derived products are top of mind for state legislatures these days. On March 10, the Virginia state legislature passed a bill legalizing cannabidiol oil, a marijuana-derived product, for patients who suffer from epilepsy. Other legislatures are actively debating measures to legalize cannabis-related products in their states, and many of these legislative proposals would allow cannabis-use for patients suffering from specific medical conditions. Last week, the Alabama state legislature debated a bill that would allow people to take cannabidiol to treat certain conditions, and Utah recently defeated a bill that would have allowed people with certain debilitating conditions to use a marijuana-related extract.
As more states pass bills allowing patients to use marijuana-derived products, will state laws clash with federal policies implemented by the Food and Drug Administration (FDA)?
Marijuana is complicated. Marijuana refers to the dried leaves and flowers of the cannabis plant. All marijuana plants contain a mixture of molecules, including cannabinoids. Different cannabinoids can have different effects, and scientists have identified more than 200 different cannabinoids from marijuana plants. Some of the most well known cannaboids in marijuana include tetrahydrocannibonol (THC), cannabidiol (CBD), and archidonoyl ethanolamide (anandamide). Continue reading →
Doctor Strafford delivered a masterful overview of the trajectory of scientific perspective and research about children and pain. Over the course of her career, the medical perspective has transformed from “children do not feel pain” to “children do not remember pain” to inquiry into “when and how children feel pain.” Strafford described the medical complexities of understanding the physical and subjective aspects of pain as well as the impossibility of confidently “pinpointing” the exact point in fetal development when a neonate experiences pain.
Professor Pustilnik gave an equally compelling review of law and legal language regarding abortion, particularly law that specifically references fetal pain as a reason for limiting abortion. This served to frame a conversation about pain and suffering in the law and the ways in which law reflects normative considerations and provides rhetoric (viewed respectively by partisans as “compelling” or “inflammatory”) to political discourse. In this case, discourse about fetal pain both attracts attention and is intended to facilitate empathy for the neonate. Continue reading →
It is fitting that I am writing this first blog of my time as Senior Fellow in Law and Applied Neuroscience as we transition through the change of seasons. It is a privilege to have the time afforded by this joint Fellowship between Harvard Law School (Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics) and Massachusetts General Hospital (Center for Law, Brain, and Behavior) to focus upon the intersections of behavioral science, developmental neuroscience, and juvenile justice. The autumnal change of seasons is a fitting metaphor for the slow but profound changes occurring in juvenile justice which have been spurred in large measure by emerging neuroscience increasingly describing the neurobiology of adolescence. This neuroscience provides the biological complement to what developmental psychologists have well described and what parents have long known: Children are different.
This emerging neuroscience has become a quiet but increasingly pervasive force in helping us understand why most delinquent youth desist with maturation—even adolescents who are chronically delinquent and violent. It helps us understand why punitive “tough on teen crime” approaches born of fears in the 1990’s of the rise of violent teen “super-predators” actually compromises public safety over time—especially when youth are tried as adults and incarcerated with adults. And, it helps us understand why mass detention and incarceration of youth—many of them for non-violent offenses—not only harms those youth but tends to increase their risks of continued misconduct and of later deep penetration into the adult criminal justice system. Continue reading →
The direct-to-consumer genetic testing company 23andMe was widelydiscussedin the news recently after it announced it would resume providing health information to customers. Less widely reported was another important announcement: for what appears to be the first time, 23andMe has released a public report about the number of requests it has received from law enforcement seeking its customers’ genetic information. According to the Transparency Report, 23andMe has received four requests for user data from law enforcement, with five different affected users.
Although 23andMe has thus far successfully fought off all of the law enforcement requests for its users’ data, there has long been concern about the potential release of 23andMe’s customers’ information to law enforcement. The 23andMe Privacy Statement states, “23andMe will preserve and disclose any and all information to law enforcement agencies” when it believes it is required to do so. Even though 23andMe has not yet disclosed any of its users’ information, the day may soon come when it is required to do so. That disclosure could have significant impacts for not only users who consented to the use of their data, but for users’ families, who may be implicated through familial DNA searches.
This morning I saw an announcement about a new initiative called “Law Enforcement Leaders to Reduce Crime and Incarceration” and thought it was an important thing to share on this blog. This alliance consists of 120 top current/former police commissioners and prosecutors, including both district attorneys and state attorneys general. These law enforcement leaders have come together to influence legislation and public opinion around mass incarceration. Their first project: supporting the Sentencing Reform and Corrections Act of 2015, a bipartisan bill currently moving through the Senate. This issue matters because there are currently over 2.2 million people in American prisons and jails.
Why is criminal justice a health policy issue? Well, there are many reasons, but let’s start with the fact that the largest mental health provider in the United States is the Cook County Jail. This does not reflect well on our criminal justice policy or our health policy.
The Rubio-Huckabee claim that actual and legal personhood start at conception has drawn trenchant responses from Art Caplan on the medical uncertainty of such a claim and David Orentlicher, drawing on Judith Thomson’s famous article, that even if a fetus is a person, woman would not necessarily have a duty to keep it in her body.
Their debate claim that the fetus is already a legal person under the constitution also deserves a response, for it has no basis in positive law. In Roe v. Wade all nine justices agreed that the use of “person” in the Constitution always assumed a born person, and therefore that the 14th Amendment’s mention of person did not confer constitutional rights until after a live birth. In the years since Roe, when the make-up of the court has changed, no justice has ever disagreed with that conclusion, including those who would overturn Roe and Casey. Continue reading →
What should the future look like for brain-based pain measurement in the law? This is the question tackled by our concluding three contributors: Diane Hoffmann, Henry (“Hank”) T. Greely, and Frank Pasquale. Professors Hoffmann and Greely are among the founders of the fields of health law and law & biosciences. Both discuss parallels to the development of DNA evidence in court and the need for similar standards, practices, and ethical frameworks in the brain imaging area. Professor Pasquale is an innovative younger scholar who brings great theoretical depth, as well as technological savvy, to these fields. Their perspectives on the use of brain imaging in legal settings, particularly for pain measurement, illuminate different facets of this issue.
This post describes their provocative contributions – which stake out different visions but also reinforce each other. The post also highlights the forthcoming conference-based book with Oxford University Press and introduces future directions for the use of the brain imaging of pain – in areas as diverse as the law of torture, the death penalty, drug policy, criminal law, and animal rights and suffering. Please read on!
The civil commitment of sexually violent predators (SVPs) is designed to protect society’s vulnerable from a group of perverts and monsters. What could be wrong with this? Only everything.
The current SVP civil commitment regime is itself a perversion – of facts, of medical ethics, and of justice. Cato Unbound usually curates excellent debates, representing a range of opinions. But in this case, we contributors, from a spectrum of backgrounds and ideological commitments, all agree: This regime is abominable. Continue reading →
Tuesday, June 30, 2015 8:00 AM – 5:00 PM Wasserstein Hall, Milstein West A
Harvard Law School [Map]
Can brain imaging be a “pain-o-meter” that tells courts when a person is in pain? Can fMRI help us discern whether intractable chronic pain is “all in your head” or all in the brain – or will it require us to reconsider that distinction? Leading neuroscientists, legal scholars, and bioethicists will debate standards and limits on how the law can use brain science to get smarter about a subject that touches everyone.
Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
In a previous post, I discussed three possible methods of increasing vaccination and decreasing vaccine refusals in the United States. One of these options was using tort law and allowing lawsuits against parents for refusing/failing to vaccinate their children. The Pakistani government has recently taken it one step further, arresting and issuing arrest warrants for parents refusing to vaccinate their children against polio. Last week, approximately 512 people, 471 in Peshawar and 41 in Nowshera, were arrested and jailed and arrest warrants were issued for 1,200 more parents for refusing to vaccinate their children.
Currently, the government allows parents to be released from jail and return home if they sign an affidavit promising to vaccinate their children. Despite the fact there is no law requiring polio vaccination, some view the recent crackdown as “a blessing in disguise” for unvaccinated children. This drastic approach responds to high rates of refusal, a contributing factor to Pakistan’s significant number of polio cases. According to the World Health Organization, in the period since March 2014 Pakistan registered 296 polio cases, the most in the world and drastically higher than even the second-highest rate of 26 cases registered by Afghanistan. Why is Pakistan’s vaccination rate so low? For many reasons, including religious beliefs, attacks on medical workers, displacement of individuals due to ongoing military operations, and a lack of trust in health care workers and the vaccine. Continue reading →
Functional magnetic resonance imaging (fMRI) evidence of lie detection has, appropriately, faced difficulty gaining evidentiary acceptance in criminal courts. While a comprehensive discussion of the case law is beyond the scope of this post, it is important to note that courts have repeatedly refused to admit such evidence, both under a Daubert test, using Federal Rule of Evidence (FRE) 702, as well as under FRE 403.
Under Daubert, which governs the admissibility of expert testimony, courts have found that fMRI lie detection falls short in meeting the necessary standards, including the identification of error rates and maintenance of uniform testing standards. Courts have also pointed out that the motivation to lie may be different in research v. real-world settings. In a laboratory experiment, one can assume that the participant is complying with investigator directions. However, if the scan is to be used in the courtroom, the subject will have a personal interest in the outcome, and may try to employ counter measures, or disregard instructions, in order to “fool” the scanner. Recent research shows that this task may not be hard, at least not for those who know how to effectively “trick” the scanner.
Judges have highlighted that while there are peer-reviewed studies of fMRI lie detection, said studies have very small patient bases (all N<60), and included a range of participants who were not representative of the general population. Courts recognize that neuroimaging, for the purposes of lie detection, is still not generally accepted by the scientific community. Both of these factors limit the applicability of the results to the general population, and to any individual defendant in particular.
Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology &Global Health Policy, University of California, Irvine School of Law
A legislative advisory committee is set to present an amended bill to the Minnesota State Legislature this session that raises the standard of care provided to incarcerated pregnant women in Minnesota prisons.
The amendment seeks to clarify language of a law passed on May 8, 2014 seeking to ensure incarcerated pregnant women receive the same standard of care they would receive outside a correctional facility. The Minnesota Senate and House unanimously passed the bill, which was described as “a first step toward providing a healthy start in life for the babies born to the estimate 4,200 women per year in [Minnesota] who are pregnant at the time of their arrest.” It was the first law to consider the unique needs of pregnant inmates. Continue reading →
The United States legal system places a great deal of importance on juries. With this faith comes a belief that juries are effective and reliable in determining the credibility of witnesses that testify in front of them. However, research has found that people, while generally good at lying, are terrible at detecting the lies of others. Scientific research has found that, in a face-to-face meeting, the average person is able to detect deception at only a slightly better than 50% rate, meaning that most people are no better at detecting deception than would be expected from pure guessing.
This tension has led courts to search for a technology-based method of lie detection, which could objectively improve on human’s natural inability to detect deception. While polygraphs have been around for a long time, there is tremendous (and well deserved) skepticism of this modality. In 2003, a National Academy of Sciences report found there was a startling lack of research in regards to the accuracy of polygraph machines under varying conditions. This study estimated that the accuracy of polygraphs was roughly 75%, but could be as high as 99% or as low as 55% depending on a variety of factors. These factors include the experience of the operator, the setting of the test (experimental vs. forensic), and what questioning format is employed.
The skepticism towards polygraphs partially explains the hope that one day, new and more accurate technology will replace them. Today, this enthusiasm is primarily aimed at the potential for functional neuroimaging to serve as an effective lie detector. Functional magnetic resonance imaging (fMRI) for lie detection is different from using a polygraph, in that neuroimaging measures the central (brain) rather than the peripheral (blood pressure, heart rate, respiration rate and galvanic skin response) correlates of nervous system activity. While, brain-based lie detection was pioneered in the late 1980s, using the method of EEG, fMRI is now touted as the preferred method, due to its superior ability to localize signals in the brain. Continue reading →
While there is considerable enthusiasm for incorporating neuroimaging technologies in the courtroom, it must be balanced with an understanding of the very real limitations of available neuroimaging data at present. I will focus on the use and study of one such technology, functional magnetic resonance imaging (fMRI), to explore some of these limitations.
Many fMRI studies have small participant groups, which means that the data may lack the statistical power needed to allow generalization of results. There are several reasons for this. Even though fMRI machines have decreased in price, they are still expensive, and since the fMRI machine is very large, it requires specialized space in order to function. Conducting a scan is also quite time consuming. For these reasons many neuroimaging experiments utilize subject groups that were not selected due to concerns related to statistical power, but rather due to practical concerns such as how much scanning time, space, and money has been allocated to the experiment.
Furthermore, the size and technology of fMRI machines necessitates running experiments in a very particular way that could affect the outcomes. Because participants are required to lie still in a small space, there is a limit to what tasks and activities they can be expected to perform. It is impossible to assess the effects that lying still in a giant scanner may have on normal behavior, meaning that fMRI machines may not accurately tell us about the human brain under normal conditions. Experimental design is especially problematic if we want to bring fMRI experiments into a criminal legal context, as it is currently impossible to design an experiment that accurately recreates the dynamic conditions of stress that are likely to occur during the undertaking of a criminal action.
The National Academies of Sciences (NAS) has just released a new report, “Identifying the Culprit: Assessing Eye Witness Identification,” prepared by a study committee equally composed of scientists and lawyers, including prosecutors and defense attorneys, and co-chaired by federal judge Jed Rakoff. The report critically examines the current status of fundamental vision research into the processes of visual memory formation, storage and recall. The committee also reviewed the current status of applied research in suspect identification techniques, pointing out that “the jury is still out” on the relative advantages and disadvantages of simultaneous vs sequential line ups and presentations of photo arrays of suspects to eye witnesses.
The central finding, supported by an abundance of robust research, is the fragility and malleability of visual memory formation, storage and retrieval, and the susceptibility of visual memory, at every step in the process, to suggestion. Visual memories of incidents are in no way like photographs that accurately record whatever is in the focus of the lens and then store those photographs permanently without alteration. The report urges that police officers and judges alike recognize these frailties and establish procedures for police officers at the scene of the crime and in administering lineups or photo arrays, that would minimize corruption of the visual formation, storage, and recollection of memories by eyewitnesses. The report urges that states develop uniform guidance for jurists regarding the conduct of pre-trial inquiries into the quality and credibility of eyewitness testimony, as well as judicial instructions to jurors in interpreting and evaluating eyewitness testimony. This is an excellent report that deserves your awareness and attention.