Category: Zachary E. Shapiro

Field hospital in NY during COVID-19 pandemic.

Ethical and Legal Challenges Faced by Hospitals in New York’s First COVID-19 Surge

zshapiro1 Leave a comment

By Zachary E. Shapiro

After COVID-19 reached the United States, New York City quickly became the epicenter of the pandemic. Clinicians at New York Presbyterian Hospital-Weill Cornell Medical Center turned to the Clinical Ethics Consultation Service to help meet the ethical challenges that arose. During the surge, the Ethics Team saw a marked increase in the volume of consultations for individual patients in the hospital, and took part in over 2,500 informal consultations with caregivers. Discussions centered around a wide range of ethical issues distinct from those that come up in routine practice. As one of the only lawyers in the Division of Medical Ethics at Weill Cornell Medical College, I encountered a myriad of legal concerns presented by the pandemic.

During the height of the surge in New York, there was no formal legal guidance available to clinicians concerning medical practice during a pandemic. Questions about legal immunity abounded, as unclear state and federal guidance left many doctors worried that they were taking personal and professional risks by providing care to COVID-19 patients.

The pandemic forced doctors to shift away from traditional standards of care in terms of resuscitation, patient care, and surrogate decision-making. The ethics team had to take new dynamics into account, such as the risk of infection to doctors and staff, and balance these factors in the risk/benefit calculations for treatments and interventions. Undertaking these shifts without federal or state guidance caused significant distress and concern. It often seemed that the law was not only not helpful, but an active hindrance to medical practice, as many health care workers were consumed by worry about the prospect of future liability. This concern persisted, even though the deviations in the standard of practice were necessitated by the realities of the pandemic overwhelming our health care system.

Read More

Big Data, Genetics, and Re-Identification

zshapiro1 2 Comments

by Zachary Shapiro

While all scientific research produces data, genomic analysis is somewhat unique in that it inherently produces vast quantities of data. Every human genome contains roughly 20,000-25,000 genes, so that even the most routine genomic sequencing or mapping will generate enormous amounts of data. Furthermore, next-generation sequencing techniques are being pioneered to allow researchers to quickly sequence genomes. These advances have resulted in both a dramatic reduction in the time needed to sequence a given genome, while also triggering a substantial reduction in cost. Along with novel methods of sequencing genomes, there have been improvements in storing and sharing genomic data, particularly using computer and internet based databases, giving rise to Big Data in the field of genetics.

While big data has proven useful for genomic research, there is a possibility that the aggregation of so much data could give rise to new ethical concerns. One concern is that promises of privacy made to individual participants might be undermined, if there exists a possibility of subject re-identification.

Re-identification of individual participants, from de-identified data contained in genetic databases, can occur when researchers apply unique algorithms that are able to cross-reference numerous data sets with the available genetic information. This can enable diligent researchers to re-identify specific individuals, even from data sets that are thought to be anonymized. Such re-identification represents a genuine threat to the privacy of the individual, as a researcher could learn about genetic risk factors for diseases, or other sensitive health and personal information, from combing through an individual’s genetic information.

Read More

Affective Forecasting and Genetics

zshapiro1 Leave a comment

by Zachary Shapiro

Psychological research on “affective forecasting,” studying individuals’ ability to predict their future emotional states, consistently shows that people are terrible at predicting their ability to adapt to future adversity. This finding has particular significance for medical decision-making, as so many serious health decisions hinge on quality-of-life judgments, generally made by an individual balancing risks and benefits they perceive of a future state that is likely to result from a given therapeutic regime.

Much of the research on affective forecasting has focused on high-stakes events, restricting study participation to those likely to find the study event particularly significant, such as tenure-track faculty, registered voters, or sports enthusiasts. Despite a growing body of research on forecasting biases in the medical domain, little work has previously systematically considered such biases in clinical genetics. However, as the prevalence of genetic testing has increased, scholars have noticed forecasting deficiencies with increasing regularity.[1]

While evidence suggests that those who receive genetic testing, whether they are non-carriers or carriers of specific genes, differ in terms of short-term general psychological distress, their long-term distress levels do not differ significantly. Results of research into the affective reactions of patients undergoing predictive genetic testing suggest that, in general, psychological outcomes are not as negative as one may expect.

Read More

Patent Law, Expertise, and the Court of Appeals for the Federal Circuit

zshapiro1 Leave a comment

by Zachary Shapiro

Since its creation in 1982, the Court of Appeals for the Federal Circuit (CAFC) has been a magnet for controversy and criticism. While I do not align myself with those critics, it would be foolish to not acknowledge the problems that are present with the CAFC. For instance, for the vast majority of federal law, when law develops differently in different circuits, the Supreme Court is able to observe those developments, and decide which interpretation is most desirable. Because the CAFC has sole jurisdiction over patent law appeals, patent law is not subject to these circuit splits. While splits temporarily hamper uniform justice, they do allow for experimentation, enabling different legal interpretations to be tested in real life. In this way, splits can allow an appellate body to make a more informed decision regarding which interpretation should be followed.

The lack of circuit splits in patent law can be problematic, given accusations that the CAFC has succumbed to a form of institutional capture by the patent lobby.[1] Critics highlight the CAFC’s decision in Amazon[2] and eBay[3] as evidence of this capture. In Amazon, the CAFC found a broad presumption of irreparable harm, allowing for broad extension of preliminary injunctions in future cases of patent infringement (even though they overturned the injunction at issue in the case). This patent-holder-friendly standard was ultimately overruled in eBay,[4] after the CAFC applied its nearly automatic injunction standard. The Supreme Court overturned this decision, and dialed back the presumption, in large part because it was seen as too favorable to patent holders.

Read More

Problems with fMRI as a tool of lie detection

zshapiro1 Leave a comment

by Zachary Shapiro

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.[1] 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.[2] Both of these factors limit the applicability of the results to the general population, and to any individual defendant in particular.

Read More

fMRI as a Tool of Lie-Detection

zshapiro1 Leave a comment

by Zachary Shapiro

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.[1] 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.[2]

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.[3] 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.[4] 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.[5]

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.[6] While, brain-based lie detection was pioneered in the late 1980s, using the method of EEG,[7] fMRI is now touted as the preferred method, due to its superior ability to localize signals in the brain. Read More

Neuroimaging and the Law: Pitfalls

zshapiro1 Leave a comment

by Zachary Shapiro

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.

Read More

The Learned Intermediary Rule and Direct-to-Consumer Advertising

zshapiro1 Leave a comment

By Zachary Shapiro

In the field of pharmaceutical product-liability litigation, the Learned Intermediary Rule (LIR) is a defense doctrine for failure to warn claims, which has been adopted in 22 states, and applied in 48. The LIR means that if a pharmaceutical manufacturer that gives an adequate warning to a prescribing physician, the company has no corresponding duty to directly warn the patient.

This rule has been justified by the belief that the prescribing physicians is “in a superior position to impart the warning and can provide an independent medical decision as to whether use of the drug is appropriate for treatment of a particular patient.” Larkin v. Pfizer, Inc. 153 S.W.3d 758, 763-764 (Ky. 2004). Furthermore, historically, pharmaceutical manufacturers lacked effective means to communicate directly to patients. Courts did not want to extend liability when pharmaceutical companies were complying with FDA regulations regarding proper warnings to consumers. Finally, there was a belief that any direct warning would interfere with the doctor-patient relationship.  Read More

Savior Siblings in the United States

zshapiro1 2 Comments

By Zachary Shapiro

With the emergence of new techniques in the field of reproductive technology, applications arise that seem more the realm of science fiction than reality. While many have considered stem cells to be the next frontier of modern medicine, reproductive technology may offer hope to many individuals suffering with rare and unique genetic diseases.

The term “savior siblings” refers to the use of pre-implantation genetic diagnosis (PGD) and other forms of in-vitro fertilization (IVF) in order to create a sibling for the purpose of providing biological material (bone marrow, blood, etc.) that can help treat or cure an existing terminally ill child. It is estimated that up to one percent of PGD in the United States is used to create children that are tissue matches for their siblings. See here.

There has been little meaningful discussion about savior siblings in bioethical or legal circles, and there is no formal regulation governing their use or creation in the United States. This stands in stark contrast to other countries, particularly England, France, and Australia, where a regulatory framework for the use of savior siblings has arisen along with debate over their acceptability. These countries are already discussing how to ethically deal with this extremely complicated issue.  Read More

Ebola, Flight Bans, and Politics

zshapiro1 Leave a comment

By Zachary Shapiro

It seems like the debate over banning flights from West African Ebola stricken countries has become instantly political, with many Conservatives calling for a flight ban. See here. One author, in response to these calls, points to the history of Liberia’s relationship with the United States as a reason that the US should not consider a flight ban. Arguments against a flight ban that are not based on public health principles provide fodder for the talking heads and individuals who want to see this as a political issue.

The real question should be how much good a flight ban would do to halt the spread of Ebola to the United States. Many public health experts, from the CDC to the WHO, do not think a ban would make us safer.

Ebola is only contagious when the patient is symptomatic, and the first symptom is almost always a fever. If a patient does not have a fever, and is asymptomatic, they are not contagious. Thus they do not provide a serious risk of infecting other people, even in the confined quarters of an airplane. This makes temperature screening especially important. This easy screening tool is already in use at airports in Ebola affected Countries.  Read More