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Nanotechnology in Medicine and its Potential Legal Implications

While two distinct fields, medicine and technology are two areas that are under constant improvement. Medical improvements are necessary to continue to combat new invasive viruses, treat current diseases with no cure, and keep unknown illnesses at bay. Technological improvements are necessary to help create efficient tools for mankind’s everyday use. Accordingly, technology has been a huge factor to help create medical improvements. As a result, a fairly new type of medical and technological improvement has gained exposure: Nanotechnology.

What is Nanotechnology?

Nanotechnology is a branch of technology that deals with dimensions and tolerances of less than 100 nanometers, especially the manipulation of individual atoms and molecules. It is science, engineering, and technology conducted at the nanoscale, which is about 1 to 100 nanometers. In comparison, a nanometer is the equivalent width of three to five atom molecules wide. The size of a virus is typically 100 nanometers. Some of the most important application fields of nanotechnology are medicine and pharmaceuticals. Within the medical field, the current applications are: appetite control, cancer, cholesterol, drug development, imaging, medical tools, bone replacement, chemical substitute, diagnostic tests, hormone therapy, and immunosuppressants.

Applications

Because nanotechnology allows scientists to attack illnesses at a molecular level, there are many applications for the technology in the medical field. Some common uses are quantum dots and drug and gene delivery.

Quantum dots (“Qdots”) are “semiconductors that emit or absorb light under specific conditions that can be manipulated externally.” Qdots, they can be used to locate ill or bad cells and scanners are used to target the previously emitted light from Qdots. As such, its application could target potential tumors in the body and diseased cells in general.  

The targeted drug and gene delivery application allows for the identification of ill cells in the body. With the help of Qdots, needed medication is delivered to the exact part of the body without harming the healthy cells. Nanotechnology increases efficiency through the use of pills as opposed to complex and time-consuming therapies, which can be costly and less effective.

The future also provides promising use of nanotechnology for tissue engineering and extensive cancer treatment. Such applications would be used to rebuild tissue at a molecular level or even identify and destroy cancer cells before malignant formation is visible.

Potential Legal Implications

Although there is minimal case law that addresses the issues of nanotechnology in medicine,there exists the possibility of harm and injury that may arise from this technology. Because nanotechnology affects the body at a molecular level, cellular injury may be harder to detect. However, as technology improves, it may be easier and may take less time to determine the injury and harm, if any, nanotechnology causes. For example, if the nanotechnology used to fix cancerous cells malfunctions and instead begins attacking healthy cells, this could prove to be detrimental. Shorter attacks on healthy cells may not demonstrate instant signs of harm, but overtime, the body may begin to react to the unknown effects and show signs of harm and injury.

Other legal implications that may arise seem to appear in nanotechnology’s most important benefit – early detection of diseases. One issue arises through the use of Qdots in nanotechnology. Once Qdots are used to illuminate the ill cells, doctors and medical professionals diagnose the issue and begin to treat the ill cells, or in this case the disease. However, misdiagnosis or failure to treat may create legal implications like malpractice suits. Also, a cure or treatment may not be available at the time of diagnosis, which may lead to more legal implications.

Lastly, potential legal implications may arise from a failure to warn about the risks inherently involved with nanotechnology usage. Although this aspect is pretty common in malpractice suits against doctors, it is important to note that in this instance the harm occurs at a microscopic level. Thus, as stated above, overtime, such damage may have detrimental effects to the human body.

Overall nanotechnology is an exciting advancement in the medicinal world. It can be very efficient and effectuate change in untapped ways. Its potential is limitless. Unfortunately, new technology in the medicinal field implies new harms and risks. Looking at the current applications of nanotechnology, the medical benefits may outweigh the risks and harms involved.

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Tracing the History of Forced Sterilization within the United States

When many people hear the phrase “forced sterilization,” they rarely associate the practice with the United States, or if they do, they believe this was something the country did more than a century ago. Unfortunately, however, coerced and forced sterilizations have been occurring since the early 1900s and have seen their most recent iterations as “voluntary” procedures offered for a reduced prison sentence. Coerced sterilization occurs when financial or social incentives or intimidation tactics are employed to compel an individual to undergo the procedure. In comparison, forced sterilization happens when a person does not know she is undergoing the procedure, has no opportunity to provide consent, or gives consent under duress.

In 1907, Indiana became the first state to successfully pass a mandatory forced sterilization law, and California and Washington followed suit a few years later. Throughout the first half of the twentieth century, the public generally supported sterilization of the mentally handicapped. In 1927, the Supreme Court ruled in Buck v. Bell that forced sterilization did not violate the Constitution. In his opinion in Buck, Justice Holmes explicitly argued for eugenics, which Nazi propaganda then cited the opinion as a basis for Germany’s forced sterilization programs.

Public sentiment surrounding sterilization began to shift following the 1940s, but the trend changed when the Nixon administration dramatically increased Medicaid-funded sterilization of low-income Americans, specifically targeting people of color and those with HIV/AIDS. This funding, combined with a federal commitment to family planning and community health, led to widespread sterilization abuse in the United States from the late 1960s to the mid-1970s. For example, the North Carolina Eugenics Board sterilized 7,600 mentally handicapped women between the 1940s and 1970s. The increase of reproductive health clinics at this time overwhelmingly benefited middle-class white women, but minority working-class women faced stigma and a family planning model that lacked standardized consent protocols, which created an environment “ripe for coercion.”

The story of the Relf sisters, who were teenagers sterilized without consent in 1973 in Alabama, mobilized many women to address forced sterilization. As the case went to trial, it was found that the girls’ mother believed she was consenting to birth control for her daughters, but because she could not read, she mistakenly signed a sterilization release. In reaction to this story, African American and Native American women throughout the United States came forth with similar allegations, and, in Relf v. Weinberger, a federal district court judge estimated that 100,000 to 150,000 low-income women had been sterilized during the early seventies. The call to action grew as awareness of the practice increased, and health departments in major cities began revising their guidelines for sterilizations, which included reviewing the consent notice and fully informing patients of the permanence of the procedure. Some jurisdictions, like North Carolina, even established governmental entities to identify victims of forced sterilization and compensate them.

Despite this, forced sterilization still occurs today, although it is reframed as a voluntary option in exchange for a reduced prison sentence. In May 2017, a Tennessee judge signed a standing order allowing inmates in White County to receive jail credit if they underwent either a vasectomy for males or a Nexplanon implant for females. Thirty-two women and thirty-eight men underwent sterilization during the three months Judge Benningfield’s order was in effect. Though Tennessee later introduced a bill that would forbid judges from approving a reduced sentence if it is conditioned upon sterilization, other states are not responding with similar legislation. In February 2018, an Oklahoma woman, who was a prior drug addict, received a shorter sentence for a federal counterfeiting offense after undergoing surgery to prevent further pregnancies. The sentencing judge, Stephen Friot, defended his decision, saying that the Supreme Court “has yet to recognize a constitutional right to bring crack- or methamphetamine-addicted babies into this world.” Actions and sentiments like Judge Friot’s demonstrate how eugenics practices in the United States have evolved and continue to violate an individual’s bodily autonomy and human rights on the whole.

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Granite State Residents File Suit Over Medicaid Work Requirements

Medicaid is a federal and state government health insurance program for persons of all ages whose income and resources are insufficient to pay for health care. States currently enjoy significant leeway in determining who is eligible for implementation of the program. In recent years, a number of states have received permission from the Centers for Medicare and Medicaid Services to make a beneficiary’s receipt of Medicaid benefits contingent upon fulfilling work requirements.

New Hampshire is one of nine states to approve such Medicaid work requirements. Among other provisions, the program will require all ACA expansion beneficiaries to participate in 100 hours per month of “community engagement activities, such as employment, education, job skills training or community service as a condition of Medicaid eligibility.” While the New Hampshire Governor Chris Sununu praised the decision as empowering recipients, many critics agree that there is no nexus between work requirements and improved health and that thousands of vulnerable citizens will lose coverage for failure to comply. In fact, roughly 18,000 citizens of Arkansas lost Medicaid coverage in the last year for failing to comply with their state’s Medicaid work requirements.

This week, residents of the Granite State became the third to challenge their state’s Medicaid work requirements in court. Petitioners suing the federal government to halt the work requirement are encouraged by a similar Kentucky law which was struck down in a U.S. District Court last year. The chief concern among those bringing the suit is that the massive coverage loss experienced by people in Arkansas will be replicated in New Hampshire. The New Hampshire state Department of Health and Human Services estimated that “up to 15,000 of the roughly 50,000-person Medicaid expansion population in the state are not working or presently exempted.” Not factored into those numbers, argue opponents of the law, are beneficiaries who juggle multiple low-wage service industry jobs with unpredictable, fluctuating hours.

The New Hampshire case against the federal government will be before U.S. District Judge James Boasberg who blocked the Kentucky law last year and who has new and similar cases on his docket from Kentucky and Arkansas. New Hampshire has hinted at the prospect of intervening in this law suit to further argue that the work requirement is beneficial to the health of state Medicaid recipients. Judge Boasberg, however, previously stated that “This is not the purpose of Medicaid,” and that the goal of the law is to provide medical and long-term care service coverage. The results of this case will have a resounding effect on similar efforts in other states to make Medicaid coverage contingent on work requirements.

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Domino’s Pizza May Deliver the Supreme Court a Chance to Modernize the ADA

The Supreme Court of the United States could soon provide greater clarity to the Americans with Disabilities Act’s (ADA) jurisdiction over websites and mobile apps.

Domino’s Pizza is reportedly preparing a petition for certiorari to appeal a Ninth Circuit decision, Robles v. Domino’s (913 F.3d 898), which held that blind plaintiff, Guillermo Robles, could proceed with a lawsuit against Domino’s after alleging the pizza purveyor’s website and mobile app were inaccessible to him using screen-reading software. On appeal, the Ninth Circuit reversed the decision of the district court and held that the ADA applies to the website and mobile application as services of a place of public accommodation. If the Supreme Court accepts Domino’s “cert petition” for Robles, the Court would have the opportunity to rule on the issue of whether websites and mobile apps must comply with ADA standards.

The ADA was passed in 1990 under President George H.W. Bush as the “world’s first comprehensive declaration of equality for people with disabilities.” Since then, the ADA has been further refined and empowered by a mix of legislation and landmark Supreme Court cases. The ADA, at its core, is a law that “prohibits discrimination against individuals with disabilities in all areas of public life, including jobs, schools, transportation, and all public and private places that are open to the general public.”

Although the ADA’s jurisdiction over those places listed above is clear, its claim over the internet has been tenable at best. The ADA still does not address digital or online compliance specifically, even as our lives become increasingly digitized. The current state of the law regarding online compliance to ADA standards is made up of a patchwork of federal appellate court decisions, which often have different or contradicting standards. This legal uncertainty was highlighted in 2018, in which over 2,250 website accessibility lawsuits were filed in the U.S., increasing from 814 the year before. Still, the Supreme Court has yet to take up one of these cases to provide clarity in the law and relief to lower courts. A ruling by the Court on a website accessibility case could replace the appellate patchwork of case law with a single federal standard.

In Robles, the district court granted Domino’s summary judgment motion and dismissed the case holding that “imposing […] standards on Domino’s without specifying a particular level of success criteria and without the Department of Justice (DOJ) offering meaningful guidance on this topic … fl[ew] in the face of due process.”

The case was then appealed to the Ninth Circuit, which reversed the district court’s dismissal, holding that the ADA applied to websites and mobile apps for operators of places of public accommodation. This holding reaffirmed the standard “that, to be covered by the ADA, a website or mobile app must have a nexus to a physical place of public accommodation.” The court expounded upon this noting that the ADA applies to services “of a place of public accommodation,” not “in a place of public accommodation.” The distinction by the court broadens the applicability of the ADA from beyond the physical space to websites and mobile apps.

The Ninth Circuit stated there was such a nexus, as the “alleged inaccessibility of Domino’s website and app impedes access to the goods and services of its physical pizza franchises – which are places of public accommodation.” Additionally, the Ninth Circuit held that due process did not require DOJ to issue specific guidelines as Domino’s had been on notice “since 1996 of DOJ’s position that its website and app must provide effective communication.”

After the decision by the Ninth Circuit, Domino’s requested a sixty-day extension to file a petition of certiorari with the Supreme Court, which was subsequently granted by Justice Kagan; the petition must now be filed by June 14, 2019. In the request, Domino’s states, “[t]he Ninth Circuit’s decision in this case presents important and complex issues concerning the scope of the ADA, the resolution of which will have a significant impact on all businesses and institutions seeking to maintain an online presence.”

The stage is set for an overdue landmark determination of the extent of ADA’s jurisdiction over websites and mobile applications if a “cert petition” is filed and granted. A decision by the Supreme Court, in this case, could have immediate and far-reaching implications for both businesses and individuals covered under the ADA. Thus, lawyers, industry leaders, and ADA-covered individuals are closely watching this case as it develops.

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“Alexa, Reinvent the Healthcare System.” 

Amazon’s move to the health care space has the potential to revolutionize the industry.

Beginning in January, 2018, Amazon has been moving towards its latest business venture: healthcare. While a shift to health care may be unusual for Amazon, the change recognizes the fact that health care is an intricate and complex business that a disrupter like Amazon could greatly influence. Healthcare is one of the biggest industries in the U.S., but also one of the most inefficient. Approximately one third of health care spending is unnecessary and is usually wasted. A number of companies have attempted to reduce some of this waste, most notably with the partnership between Amazon, Berkshire Hathaway and JPMorgan Chase. These three businesses have a combined 1.2 million employees and the hope is their partnership will allow them to bring costs down in their own health care plans. This announcement has already had an impact on the healthcare community and drawn notice from other stakeholders in health care. 

According to the alliance, this business venture will not be aimed towards making a profit, but instead will focus on reducing the costs of the healthcare system and making the system easier to navigate. Dr. Atul Gawande, a physician and advocate for health care reform, has been chosen to lead this new venture. While details about the venture are not yet known, Dr. Gawande’s past comments have hinted that he will concentrate on three main issues: improving health benefits, boosting primary care and lowering pharmacy costs. 

The venture has also examined additional ways to lower health care costs, such as purchasing the pharmacy startup, Pillpack and investing in better software to compile medical records.Some see this as a move to make an online pharmacy platform that would allow patients to simplify obtaining prescriptions, moving the entire process to a personal, computerized system. Amazon may be able to capitalize on this new market through their existing success in online retail services. Amazon already provides medical supplies to hospital systems and they may be able to further expand within this market through sales of prescription drugs. Additionally, Amazon may also be able to integrate their Alexa home assistant technology into an integrated health program. Recent projects have used Alexa to monitor personal health, provide first aid response and report medical data. Increased utilization of Alexa-related services would allow for greater integration of Amazon products within the health care industry and may create additional ways to bring down costs. 

Amazon’s move to the health care space has the potential to revolutionize the industry, as they may create a more efficient system that other large businesses may choose to adopt. The increased uncertainty for medical practitioners will likely lead to a number of legal questions, such as issues of data privacy and monopolistic behavior. There will likely be some government regulation of these new businesses and it will be essential to keep up-to-date with legal changes to allow businesses to stay in compliance as well as participate in these new ventures.

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