Category: Blog

“Neurolaw”: The Role of Neuroscience in Sentencing

On March 20, 1981, John W. Hinckley, Jr. shot President Ronald Reagan and three others, and the following year, the jury found him not guilty by reason of insanity largely because of the presentation of scientific evidence during trial. During trial, Hinckley’s defense team introduced a computerized axial tomography (CAT) scan that suggested he had an atrophied brain, which is a common feature among those with schizophrenia. While the CAT scan did not prove that Hinckley had schizophrenia, it was enough to convince the jury to find Hinckley not guilty by reason of insanity. Nearly 41 years later, the incorporation of neuroscience into law, known as “neurolaw”, has dramatically expanded, particularly within the courtroom.   

Currently, neuroscience is used in the courtroom through several methods, such as presenting medical history, brain scans, and neurophysiological tests at trial. When medical history is presented at trial, judges are required to consider its information when reaching a verdict. Given that approximately 25% of defendants suffer from a mental illness, this is especially relevant when determining a defendant’s competency to stand trial. A second example is through brain scans, which can help determine correlations between activity in particular brain regions and human behavior. Lastly, neurophysiological tests are a current way to assess a defendant’s mental health by evaluating whether they had the requisite mental state to be held responsible for a crime.  

Generally, mentally ill defendants are sentenced to jail or a psychiatric hospital. If a defendant is found guilty but mentally ill, they are typically placed in a mental hospital and treated for their illness, rather than imprisoned. Sometimes, the defendant is neglected mental health treatment and placed in a jail. If a defendant is found not guilty by reason of insanity, oftentimes they are placed in a psychiatric hospital. While found not guilty, this verdict does not mean that the defendant is free to return to society. Incarceration without treatment has been linked to worsening a defendant’s mental health. In a Bureau of Justice Statistics survey, defendants were asked about their mental health 30 days before being incarcerated; 14% of those surveyed said they were having severe psychological distress. This rate doubled to 26% when defendants were asked about their mental distress while in jail. In jail, individuals face isolation and demoralization, which is not productive to those suffering from mental health issues. If these individuals are released after incarceration, they are more likely to reoffend. In contrast, individuals that received treatments for their illness were less likely to reoffend when released. For these reasons, neurolaw can aid in giving mentally ill individuals the proper treatment and punishment.

There are several advantages to expanding the field of neurolaw, including the actual treatment for mentally ill offenders, the use of risk prediction for crime prevention, and early inmate release. Using neuroscience in criminal cases would highlight treatment needs for mentally ill offenders, giving them a chance at recovery and management rather than just being sentenced to jail time. Risk prediction and assessment in neurocriminology can be used for prevention of future crimes and prediction of the offender’s likelihood to reoffend. Neuroscience can be used to help predict and therefore prevent crimes before they occur. This use of risk assessment could be integrated into prisons and mental health hospitals and act as a tool to release those offenders who are not considered a threat. 

Often times, mental history is overlooked, and defendants are punished without a chance of rehabilitation. When these offenders are released back into society, their chances of recidivism are even higher. Neuroscience methods, specifically the use of medical history in the courtroom, would allow judges and juries to understand the scope of a defendant’s mental history, allowing them to make more informed decisions about where to place a defendant if determined guilty. Ultimately, the merging of science and law provides diverse ways of thinking that can be used as an advantage to greatly improve the criminal justice system. While the use of neuroscience in the courtroom in determining sentencing has significantly expanded over the last few decades, there is still room for considerable expansion as technology continues to advance.

Inhumane Living Conditions: How the D.C. Jail Imposes Cruel and Unusual Punishments

The intersection between health care and prison reform has arguably never been more publicly visible than through the inhumane living conditions endured by the detainees at the D.C. county jail. This jail has consistently come under scrutiny regarding its conditions including, but not limited to, extreme confinement lasting more than 400 days and a class action lawsuit pertaining to proper COVID protocols. Unfortunately, this is just one example of the many jails, prisons, and detention centers in America that force detainees to suffer through uninhabitable conditions.

An impromptu inspection in October of 2021 revealed that the D.C. jail’s roughly 1,500 detainees are forced to live in systemic, inhumane and unsanitary living conditions. Notedly, many of these detainees have yet to be found guilty and are currently awaiting trial. These egregious conditions range from denial of food, water, and showers for punitive reasons, cells filled with sewage and bloodwater leaks, moldroaches, and lack of access to necessary medical care. There is no question that long term exposure to these conditions leads to physical and psychological trauma, which increases the likelihood that they will require future medical care.

Many representatives have likened the jail’s conditions to unconstitutional, cruel and unusual punishments. Even Marjorie Taylor Greene drew attention to the matter by visiting the January 6th defendants and claimed they face conditions worse than the homeless and prisoners of war. The roughly 40 January 6th detainees, however, are located in the Correctional Treatment Facility (CTF). They are isolated from the jail’s general population with more sanitary conditions, and thus they will not be transferred immediately. In fact, many of the jail’s other detainees have filed emergency motions to transfer into CTF.

A 2015 report on D.C. prisoners’ living conditions proves that authorities were notified of these inhumane living conditions. These conditions, however, are nothing new to the Black detainees who make up 87% of the jail’s populationand have repeatedly complained throughout the years. It is no surprise that U.S. media attention and legal action began to rise due to complaints made by the mostly white, January 6th defendants. Recently, a U.S. judge held D.C. jail officials in contempt for delaying medical treatment to a January 6th defendant that broke his wrist in custody and required surgery. This judge further recommended that the Department of Justice investigate potential civil rights violations at the jail.

Following the 2021 inspection and recent legal actions, the U.S. Marshal ordered the transfer of all sentenced inmates beginning November 8, 2021. Unfortunately, many of these inmates will be transferred to a prison in Lewisburg, PA where living conditions are not much better and inmates will likely have less access to their lawyers. “The notion that Lewisburg is an improvement over the D.C. jail points to the degree of human suffering occurring right now,” said the D.C. Public Defenders Office. The rest of the detainees will remain in D.C. until their upcoming hearing dates where they will either be released or quarantined before being transferred to Lewisburg or federal prison. 

A silver lining can be found in the midst of these civil and constitutional rights violations, notwithstanding what it took to get them formally recognized. D.C. officials were forced to address these inhumane living conditions due to the influx of complaints, media attention, investigational reports, and legal actions. A local task force created and expedited a plan to replace the D.C. facility, which will be completed by 2027. This new facility will presumably be equipped with the safe, sanitary living conditions that these inmates deserve. 

In addition to human rights violations, it is also interesting to note the financial impact that systemic treatment of inmates across the U.S. has on the American economy and individual taxpayer. The Supreme Court previously determined that inmates have a constitutional right to medical care while in custody. Although inmates may retain pre-incarceration private insurance coverage, a majority qualify for Medicaid and Medicare. Those programs, however, often refuse to pay for health care during incarceration leaving states responsible for covering the cost in order to avoid constitutional violations. Thus, it is in the federal, state, and local governments’ best interest to maintain livable jails and prisons to reduce financial costs in addition to constitutional and civil rights violations. It is imperative that safer living conditions are incorporated in the discussion of prison reform; our nation’s incarcerated, taxpayers, and government will be better off for it.

Pulling Teeth: Why Dentists Wrongly Oppose Adding Dental Coverage to Medicare

The American Dental Association (ADA) is a dentist membership organization with a mission to “help dentists succeed and to advance the oral health of all individuals.” If advancing oral health for everyone is a crucial part of their mission, why does the ADA oppose expanding Medicare Part B to include a dental care benefit?

Medicare currently does not cover dental care, but after months of negotiations, the Build Back Better legislative proposal wanted to change that by adding a dental benefit to Medicare Part B. Doing so would bring dental coverage to millions of beneficiaries. Most people would expect the leading organization representing America’s dentists whose stated mission includes advocating for oral health to support this proposal, but the ADA is very clear in their opposition. The ADA wrotein a letter to the Chairman of the House Ways and Means Committee that they “cannot support the legislative proposal being considered by the House Ways and Means Committee to expand Medicare Part B to include dental care.”

The real question is why? The ADA has concerns that this proposal would not “benefit those low-income seniors who need dental care the most” and the proposal would not adequately reimburse dentists for the services provided. The ADA instead advocates for creating a separate Medicare program focused on dental care that is means tested, covering seniors up to 300 percent of the federal poverty level. In the end, it looks like the ADA has succeeded in blocking dental care for millions of seniors touting that “[a]fter intense ADA lobbying for a targeted benefit and strong grassroots efforts” the Medicare dental benefit was removed from the White House’s Build Back Better legislative outline.

For many, dental care is unaffordable and routinely is care that people forgo altogether because of cost. Deconstructing the ADA proposal makes clear that it prioritizes reimbursement for dentists over care for patients. Creating a separate program in Medicare is a mimicking of the Medicare Part D prescription drug benefit that is wholly privatized. Private insurance reimburses providers at higher rates, but is more expensive for patients and they are more likely to have instability in their coverage compared to public insurance programs. 

The ADA proposal would also means test their new program bringing out the same argument used by people opposed to public programs—that a universal benefit helps rich people more than it does those who are low income. Contrary to the austerity informed policies that the ADA advocates for, universal programs ensure longevity and protect low-income individuals with the security that their coverage will not be snatched away next Congress. Means testing a program like dental care extrapolates a larger issue within health care policy in the United States—that helping anyone above a certain income level is bad policy. 

In challenging austerity politics, it is importantmuch like Ginia Bellafonte did in the New York Times and Megan Day inJacobin—to posit, so what? So, what if people, including rich people, can receive dental care? Accepting austerity eliminates conversations about universal rights. It forgoes questions of whether everyone deserves dental care, and for that matter all health care. Organizations like the ADA, and issues like dental care are one part of a commodified health care system that accepts means testing, privatized benefits, and austerity as solidified—that is just the way things are. 

Health care policy is infused with this mindset, universality until recently was confined to progressive think tanks, academia, and a subset of progressive politicians but has burst into the mainstream. American health policy needs to expand its horizons to recognize that health care is a human right, and human rights should not be means tested. Austerity politics carves people up, separating people who are deemed needing of care and those who can obtain it themselves. Universal programs bring us together, it opens up a dialogue on the right to receive care not the ability to pay for it. Advocating for public health—like the ADA states it does—should not include privatization or means testing dental care, it requires shifting the debate on health care to focus on covering everyone. 

Vaccine Liability in the COVID-19 Pandemic

The emergence of a novel coronavirus, SARS-CoV-2, the virus which causes COVID-19, has set off a cascading series of public health reactions unpresented in modern times. International travel shuttered to a halt as public health professionals sought the control the spread of COVD-19 through the traditional paradigm of identifyingisolating, and controllingcases. On the international stage, the World Health Organization (WHO) declared the 6th Public Health Emergency of International Concern since the 2005 revision of the International Health Regulations. In this context, a new set of authorities and liabilities schemes rapidly become applicable.

The ultimate goal in the control of any communicable disease is the development of a safe and effective vaccine capable of reducing morbidity and mortality. To encourage rapid innovation, medical countermeasures benefit from an array of traditional and pandemic-specific alternative liability structures. For the past 35 years, the National Vaccine Injury Compensation Program (VICP) has created an alternative liability structure for adverse events temporally connected to routine vaccination. Funded by a $0.75 excise tax on each disease prevented per vaccine dose, a pool of funding is available to compensate victims of certain vaccine related injuries. Originally created by the National Childhood Vaccine Injury Act of 1986, the VICP requires injured parties to present their claims to the U.S. Court of Federal Claims for a special master to adjudicate. The law requires the Department of Health and Human Services (HHS) to create a Vaccine Injury Table listing covered vaccines and adverse events. Injuries sufficiently linked to a covered can generally receive economic and non-economic damages.

A key element of the government’s response to a major emergency is the invocation of special authorities. Beginning on March 17, 2020, HHS issued the first of several declarations under the Public Readiness and Emergency Preparedness (PREP) Act. Among other things, the PREP Act provides extensive immunity to medical countermeasures, including “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID–19.” This immunity bars nearly all suits, absent willful misconduct, federal enforcement actions or equitable relief, for covered persons who “prescribe, administer, or dispense” countermeasures such as the EUA approved COVID-19 vaccines. Additionally, a PREP Act declaration shifts the vaccine liability structure from the VICP to the Countermeasures Injury Compensation Program (CICP). While relatively similar in premise to VICP, CICP covers injuries from vaccines developed during the declared emergency and require congressionally allocated function. Unlike VICP, who’s decisions can be appealed to the traditional courts, decisions of the CICP are unappealable.

Beginning in the early days of the COVID-19 pandemic, more than 200 candidate vaccines were identified, and traditional vaccine technologies were expanded to include DNA, RNA, protein-based technologies. Through an initiative codenamed Operation Warp Speed, the United States (U.S.) government invested unprecedented funding into vaccine development, including manufacturing doses potentially at a loss, to ensure prompt availability of promising candidates immediately upon approval. To date, the U.S. Food and Drug Administration authorized 3 vaccines under their Emergency Use Authorization (EUA) process, and the WHO authorized 8 vaccines through their equivalent, Emergency Use Listing (EUL) process.

In routine times, a governmental interest exists in encouraging the development of lifesaving vaccines. Following adverse events in the 1980’s involving the diphtheria, tetanus and whole-cell pertussis (DTwP) and live polio vaccines, the government created an alternative liability structure to insulate vaccine developers and spur innovation in an already highly regulated industry. To further expedite innovation during a declared public health emergency, even greater authorities and liability shields can be activated. Ultimately, the unusually strong liability protections EUA COVID-19 vaccines enjoy demands the utmost public confidence in the approval process.

For more detailed analysis on vaccine liability in COVID-19, see this article.

Analyzing Theranos: Why Medical Tech Needs More Defined Whistleblower Rights

From developments in data cloud software that enable hospital systems to improve internal efficiency to developments in nanotechnology that enable the targeting of individual cancer cells, the healthcare field benefits significantly from increased intersection and collaboration between tech and medicine. However, despite the huge potential for good that comes with this intersection, sometimes what works in a tech setting doesn’t work when applied to the development of a medical device. This is very apparent in the trial of Elizabeth Holmes, the founder of medical startup Theranos. Holmes claimed to have developed a device that could perform over 240 blood tests on a single drop of blood and have the results back to the patient within hours. This medical advancement was hailed as on par with the development of penicillin. The only problem: it was all a hoax. 

The devices simply did not work. Even when the devices succeeded in testing blood samples, the results were so wrong most of the time that they endangered patients. Imagine getting a false positive for cancer, herpes, or diabetes. Or worse: a false negative. What makes this case one that has garnered so much attention is the fact that Holmes was well aware of the devices’ inaccuracies and inadequacies: when the prototype was far from full development, she told investors that the devices were ready to be rolled out to storefronts; when employees told her the devices’ results were wildly inaccurate, she told investors they could be relied upon by doctors and patients. Many have been left asking: how could a company get so far—valued at 10 billion dollars in July 2015—when both the technology and the company were so inherently flawed?

While the answer is not simple, the ‘fake-it-till-you-make-it’ attitude widely celebrated in Silicon Valley seems to be a convincing culprit. Budding tech CEOs idolize figures like Steve Jobs, and Uber founder, Travis Kalanickfor their entrepreneurial spirit in (sometimes questionably) maneuvering their way around the rules. However, problems occur when this approach is applied to medical tech. While not having all the bugs worked out of a new ride-share app before launching might have some adverse consequences that can usually be curtailed, doing the same thing with a medical device could seriously and negatively affect hundreds of thousands of patients.

Yet, because of the cutthroat nature of Silicon Valley competition for venture capital, many tech startups, including Theranos, have relied heavily on nondisclosure agreements to ensure trade secrets are kept secret. John Carreyrou, investigative journalist largely responsible for unmasking Theranos’ fraud, describes in his book ‘Bad Blood’ how Theranos was able to silence many of its ex-employees by wrongfully leveraging nondisclosure agreements. While there are many potential legal remedies to encourage more transparency and hopefully prevent fraud like that of Theranos, better-adapting whistleblower protections to the medical tech setting seems like a promising option. 

Currently, whistleblower protections vary significantly across states. Despite wide variation, most states have some form of statute forbidding employers from discharging employees because of whistleblowing. However, employers can still easily file claims against whistleblowers for breach of nondisclosure agreements or for misappropriation of trade secrets. Though the 2016 Defend Trade Secrets Act (DTSA) endeavors to give whistleblowers immunity from claims of misappropriating trade secrets, courts have held that the statute’s immunity provision only gives the whistleblower an affirmative defense rather than sovereign immunity. Additionally, though the DTSA requires that employers inform employees of their whistleblowing immunity rights, this requirement can be satisfied simply by cross-referencing to a company policy that sets forth the provision. Lauren Rogal, legal scholar, posits that employees need to be more effectively notified of their whistleblower protections—had Theranos been required to adhere to a higher standard of notice, it’s possible that employees would have come forward sooner (page 1697). Ultimately, creating stronger requirements for notice of whistleblower protections, among other reforms, can help ensure that employees understand their rights and are empowered in keeping companies accountable. Enacting legislative reform to focus on the specific field of healthcare tech as it relates to whistleblower protections will prove incredibly important as advancements in healthcare tech continue to define the medical field.

DMDM Hydantoin: Irritant and Possible Carcinogen

DMDM Hydantoin is a preservative used in certain shampoos, conditioners, and other hair care products. DMDM Hydantoin functions as a formaldehyde releaser or donor. It works by slowing releasing formaldehyde over time to prevent the growth of harmful mold and bacteria as well as other microbes, therefore increasing the shelf-life of cosmetic products. According to a study done by the Actas Dermo-Sifiliográficas in Spain, the chemical has increased the risk of contact dermatitis and irritation in consumers who are already sensitive to formaldehyde exposure. 

The FDA lists DMDM hydantoin as a common allergen in personal care products. Current research on the chemical has produced varying perspectives. Formaldehyde is a known carcinogen. At high concentrations, it can cause chemical burns, though this is mostly an occupational hazard. A 1998 safety assessment found the chemical to be safe as a cosmetic ingredient at concentrations up to 1%. However, a more recent 2016 study found that formaldehyde releasers can lead to irritation at low levels of exposure. Still, other doctors claim that the levels of formaldehyde that DMDM hydantoin releases is negligible and should not be causing irritation on its own. However, this also depends on one’s sensitivity to formaldehyde; up to 11.9% of the population is allergic to formaldehyde when exposed to a 2.0% formaldehyde patch test. Sensitivity can also develop over time with repeated exposure. 

DMDM hydantoin is the current focus of class-action lawsuits against Johnson & Johnson as well as Unilever. Plaintiffs are claiming that exposure to the preservative has caused hair loss and irritation. Plaintiffs have filed two class-action lawsuits against Unilever who manufactures the TRESemmé line of hair products. The suits allege that Unilever misrepresented their product and did not adequately warn consumers of the chemical and the hair loss it could cause. Plaintiff Emily Castillo claimed that Unilever had misrepresented their TRESemmé Keratin Smooth Color Shampoo as being safe and effective. Rather than helping nourish her hair, the shampoo allegedly caused scalp irritation and hair loss. 

Similarly, plaintiff Larissa Whipple has sued Johnson & Johnson for their OGX hair care products, claiming affirmative misrepresentations where the company claimed the products would nourish, cleanse, and repair hair. Instead, they have allegedly caused hair loss and scalp irritation for thousands of consumers. Johnson & Johnson had initially announced in 2012 that they would remove DMDM hydantoin from their products by 2015, claiming that it did not meet their safety and care commitment guidelines. The company later clarified that the chemical would still be used in a “small number” of their products.             Ultimately, is DMDM hydantoin extremely dangerous? The jury is still out, in both a scientific and a legal sense. More research is needed to establish a stronger link between the formaldehyde releaser and potentially carcinogenic effects. The pending class action lawsuits are still awaiting class certification, as well. Only time will tell, but it seems prudent to pick hair care products with less potentially harmful preservatives.