In 1997, Benjamin Schreiber was convicted of first-degree murder and sentenced to life in an Iowa prison. In March 2015, Benjamin fell gravely ill. He developed kidney stones which “caused him to develop septic poisoning,” and was brought to the hospital in critical condition. Though Benjamin had a do-not-resuscitate (“DNR”) order in place, he was resuscitated five times. Once Benjamin became stable, the medical staff operated on and repaired organs that were damaged. In 2018, Benjamin filed a lawsuit seeking post-conviction relief, alleging that he should be released from prison. He contends that because he “momentarily died” in the hospital, he had satisfactorily served his life sentence. The Iowa Court of Appeals found this argument unpersuasive, stating that the Court “[did] not believe that the [Iowa] legislature intended…to set criminal defendants free whenever medical procedures during their incarceration lead to their resuscitation by medical professionals…” Benjamin also alleged a violation of his due process rights because the hospital did not respect his DNR. Court records confirm that Benjamin’s brother, who was at the hospital with Benjamin, instructed the hospital staff only to give him medicine to ease his pain, “but otherwise…let him pass.” The lower courts and the Iowa Court of Appeals did not address Benjamin’s due process argument. Though Benjamin’s argument that he should be released from prison was found to lack merit, it may be possible that Benjamin could recover in a civil action because he was resuscitated against his wishes.
In 2016, California strengthened its vaccination laws with the goal of increasing rates of vaccination amongst children in the state. The new law prohibits parents from seeking personal and/or religious belief exemptions. Now, only medical exemptions are permitted. On its face, it appears that the law is achieving its intended goal. During the first year that the law was in effect, “the state’s kindergarten vaccination rate shot up from 92.8% to 95.6%.” However, the number of unvaccinated homeschooled children quadrupled the first two years of the law’s enactment. Additionally, the number of children receiving medical exemptions increased to 70%. Since California’s law did not repeal medical exemptions and only extends to children enrolled in California schools, many loopholes exist allowing parents to keep children unvaccinated. Fortunately, there are efforts to close these loopholes. One such law will permit the government to review exemptions issued by doctors who have issued five or more medical waivers to vaccination so as to deter fraudulent exemptions.
Medical institutions have utilized algorithms in the provision of health care. Many of these algorithms have been useful in triaging patient care. However, one such algorithm may be detrimentally impacting access to health care and exacerbating existing health care disparities. A study from the University of California found that an algorithm that determines which patients receive priority access to “high-risk health care management programs” was racially biased. This algorithm erroneously accepted healthier white patients to the health care management program instead of accepting black patients who needed the services more. If the algorithm’s bias were corrected, it would “double the number of black patients automatically admitted” to the programs. Alarmingly, this particular algorithm is “widely used in the healthcare industry,” and many variations of these algorithms are employed by health care providers across the nation. The racial bias in the equation is a consequence of the algorithm’s structure, which correlated patient risk with health care costs. High health care costs do not necessarily correlate with the degree of sickness. As one executive highlighted, “[i]nstead of being trained to find the sickest, in a physiological sense, [these algorithms] ended up being trained to find the sickest in the sense of those whom we spend the most money on…And there are systemic racial differences in health care in who[m] we spend money on.”
The Canadian Department of Health has recently made a decision to allow the public to access the clinical trial data that “companies submit when seeking approval for a new drug, biological treatment, or medical device.” Though drug manufacturers can negotiate possible redactions of the data with Health Canada, Health Canada retains ultimate control over what information gets redacted and what information is published in reports. Health Canada has already released data for four new drugs and soon plans to release data for thirteen other drugs and three medical devices. Health Canada’s decision to make this data public is similar to the decisions of agencies in other nations, such as the European Medicines Agency (“EMA”), which also makes such data publicly available. On the contrary, the U.S. Food and Drug Administration (“FDA”) treats clinical trial data submitted to the FDA as confidential and rarely makes it available to the public. The FDA claims that U.S. laws prevent such disclosure of data. Despite the FDA’s contention that disclosure would be against the law, legal experts argue that the FDA is entitled to substantial deference in deciding which data should be kept confidential. It will be interesting to see whether the FDA continues its current trend of keeping the data private or if it will, like Canada Health and the EMA, make this information available to the public.
Vincristine is a critical chemotherapy drug used in the treatment of most childhood cancer. Its use is most prevalent in treating childhood leukemia, lymphoma, and brain tumors. Its wide-spread use, coupled with the lack of a comparable substitute, makes the shortage of Vincristine that much more deleterious for patients with the specified cancers. Up until recently, Pfizer and Teva Pharmaceutical Industries were the sole manufacturers of Vincristine. However, in July, Teva informed the Food and Drug Administration of its “business decision” to discontinue production of Vincristine, leaving Pfizer as the sole supplier. Currently, Pfizer faces manufacturing troubles, consequently enlisting the aid of the FDA to ensure the drug’s availability to patients in need. Even with this FDA support, doctors are grappling with an unimaginable situation of having to ration doses to children who need it so desperately. Although drug shortages have become an all too common situation in the United States, substitutes or alternative therapies are usually available. The unsettling reality of this shortage is that there is no alternative therapy that exists for this drug.
The United States does not have a universal protocol for evaluating the viability of organs for donation. Instead, the country is divided into 58 independent zones, each with its own organ procurement organization (“OPO”). OPOs are responsible for: determining what organs are suitable for donation at the time of a person’s death; obtaining consent for their donation; and collecting and transporting the organs. Inconsistencies among the evaluation standards employed by the various OPOs create problems: each of the 58 OPOs employs independent standards in determining an organ’s viability for donation. Furthermore, no deterrence action is implemented for an OPO that allows usable organs to go to waste. Presently, OPOs lack a method for objectively evaluating their organ procurement programs. Rather, OPOs subjectively self-report their progress to the government. The resulting variance in the evaluation standards makes it difficult to accurately gauge and compare OPOs’ performances against one another. In addition, the government lacks protocols to effectively identify and issue accountability of poorly performing zones. Fortunately, this may change in the future. The Trump administration plans to implement stricter standards that would allow for a level-playing field on which it will become possible to compare OPOs and encourage performance improvement for those underperforming.
DNA testing has become increasingly widespread. The possibility of discovering a relation to a celebrity or uncovering an unknown heritage motivates some to purchase DNA testing kits through 23andMe or Ancestry DNA. However, few people realize that these simple tests bring about privacy concerns, whether the tests are done at home or at medical institutions. The results from DNA testing have a much wider use than just tracing your roots or confirming your identity. Anonymity is not secure, and family secrets can be unraveled. These genetic results can be used by law enforcement to track down criminals and/or by drugmakers to facilitate their latest discovery. And drugmakers are expending hundreds of millions of dollars to access patient DNA results to unlock disease insights and discover new drugs. Private deals between hospitals and drugmakers are a huge privacy concern. Agreements exist that bar such sharing of private data, but, when they enter into exclusive corporate agreements, hospitals do not always disclose when the data will be used. An issue that remains at the heart of healthcare is privacy – now that concern broadens to the ethics of genetic research.
As a registered nurse and transplant coordinator, Karl Neumann was acutely aware of the shortage of donated organs and always wanted to help others by becoming an organ donor. However, given his HIV-positive status, he was unable to do so. Until recently, HIV-positive individuals were barred from registering as organ donors amaking a living organ donation. This all changed in 2013, when the HIV Organ Policy Equity Act, also known as the HOPE Act, was signed into law. The HOPE Act enables HIV-positive donors and enabled donors to offer their organs to HIV-positive recipients. In the wake of the law’s passage, Neumannn decided to become a donor, and subsequently, donated his kidney. On September 12, 2013, his donation led to the second live HIV-positive kidney transplant in the United States.
The cost of medication throughout the U.S. is among the highest in the world. The American patent system remains responsible for overseeing the influx of new medical drug and device innovations. In theory, upon the expiration of a patent, generic drugs can be distributed (almost always at a lower cost). Many Big Pharma companies, however, are circumventing the patent system in order to delay the entry of generic drugs into the market. That can happen, for instance, by a drug company re-patenting an existing drug with a new dose schedule after the original patent has expired. As a result of this sort of practice, Big Pharma companies are able to secure monopolies in the market and drive drug prices up, undermining the incentive to innovate.
On July 25, 2019, Governor Andrew Cuomo signed the Stop Hacks and Improve Electronic Data Security (“SHIELD”) Act into law. Notably, the SHIELD Act broadens the definition of a “ data breach” and further expands data breach notification requirements. Under the SHIELD Act, a data breach occurs any time private data is acquired or accessed without authorization. In addition to providing breach notifications to affected individuals and the Secretary of Health and Human Services, health care entities are required to notify the New York State Attorney General’s Office. As precautionary measures, health care entities should avoid disclosing the personal and/or medical information of their patients without their consent. It is crucial for these entities to be aware of the SHIELD Act and the new requirements it imposes.