Author: Tyanna Robinson

In the rapidly evolving world of reproductive technologies, in vitro fertilization (IVF) stands out as a beacon of hope for countless individuals striving to conceive. As this technology advances, it is increasingly confronted with complex ethical, legal, and medical challenges. These challenges highlight the ongoing struggle to maintain a balance between facilitating medical innovation and ensuring rigorous regulatory practices while also prioritizing comprehensive patient care.

A recent incident involving CooperSurgical, a major supplier in the fertility industry, brings to light this balance between innovation and regulation in the fertility industry. The company is facing several lawsuits from patients who claim that one of its products—a nutrient-rich liquid that helps fertilized eggs develop into embryos—was defective, destroying the embryos for potentially thousands of patients worldwide. This incident not only underscores the vulnerabilities inherent in assisted reproductive technology (ART) industries but also the critical importance of ensuring that the advancements in ART are matched with effective legal frameworks and ethical standards. Addressing these challenges is essential to safeguarding patient interests, and ensuring the pursuit of fertility treatment is safe and effective.

This week, the Food and Drug Administration (FDA) issued a notice stating that CooperSurgical recalled three lots of the liquid used for embryo transfer in multiple clinics during November and December. While CooperSurgical notified the affected clinics on December 13^th, it is unclear how many bottles of the botched media they used before the recall. In lawsuits filed by impacted patients, the plaintiffs assert that the defective product purportedly lacked magnesium, a key nutrient whose absence halted the development of their embryos, rendering those embryos unviable for transfer. These lawsuits further demonstrate the challenging and emotional journey of IVF for individuals seeking fertility treatment that is further complicated by corporate negligence and product recall. In the most recent of eight lawsuits filed, a couple received a phone call on Thanksgiving notifying them that all the embryos had stopped growing. Unaware of the product recall, the plaintiff attributed this failure to herself, blaming her age, before being notified two months later that the clinic used the defective CooperSurgical media on her embryos.

Infertility affects approximately 1 in 8 couples in the United States, many of whom turn to IVF as a solution. Fertility medicine and ART are relatively new fields with the first live birth from IVF occurring in 1978. However, since this breakthrough, IVF has rapidly become a common remedy for those seeking infertility treatment and now accounts for 1.6% and 4.5% of all live births in the United States and Europe. The growing demand for IVF incentivizes companies like CooperSurgical to position themselves as leaders in a largely unregulated industry. The regulatory landscape of assisted reproduction is complex as the U.S. Department of Health and Human Services exerts only limited oversight over fertility clinics. The lack of stricter federal regulatory practices incentivizes corporations to prioritize economic considerations over ethical principles in their decision-making. CooperSurgical owns multiple large sperm and egg banks, bringing in $1.2 billion in revenue last year with 40 percent coming from fertility services and supplies. This lucrative market for fertility treatment underscores the recent trend in manufacturing issues resulting from rapid growth and consolidations in those companies that supply the industry with their products. The IVF journey, while filled with hope for individuals facing infertility, is fraught with challenges that demand attention from medical professionals, regulatory bodies, and legal authorities. The issues that arise out of the case against CooperSurgical are a stark reminder of the devastating impact that corporate oversights, a lack of stricter regulatory practices, and overall disregard for an already emotional process can have on individuals’ lives. As the field of reproductive medicine continues to evolve, it must do so with a commitment to protecting patient care and ethical standards.

By Tyanna Robinson

In the ongoing conversation about mental health and wellness, the Peace Corps has become a focal point in addressing the issue of stigma. The Peace Corps is an independent government agency aiming to provide sustainable solutions to the world’s humanitarian crises. It deploys volunteers to address challenges relating to agriculture, economic development, health, education, and the environment. To become a Peace Corps volunteer, applicants are required to undergo an extensive recruitment process in which they undergo medical screening. However, the health screening policy has come under fire as many have accused the program of discrimination against individuals with histories of mental health conditions.

The Peace Corps is the subject of an ongoing class-action lawsuit where the plaintiff alleges she was denied medical clearance based on a history of mental health challenges. In Doe v. Spahn, the plaintiff claims the Peace Corps offered her a job in February 2020 as a volunteer, but after completing a “Health History Form,” the organization denied her medical clearance. While the Peace Corps medical clearance policy holds that current and/or past engagement in mental health counseling alone is not a reason for medical non-clearance, the suit also includes nine other individuals whose invitations were also rescinded for mental health reasons revealing a problematic pattern.

The Peace Corps remains unwavering in its support and application of its current medical and health policy. They note that statutory responsibility falls upon the agency to provide any necessary medical care for volunteers during service. If an individual were to face a mental health crisis overseas, the agency may not be able to readily address the situation with the same care and resources that are more easily accessible in the United States. However, those challenging the policy express that rejection of this type has been demoralizing for applicants who consider why reasonable accommodations have not been implemented to make room for the growing number of individuals with a history of treatment or counseling. They also allege that these decisions were not made based on current medical knowledge, questioning whether the Peace Corps’ information used for decision-making is accurate and up-to-date.

Mental health advocates express growing concern about the healthcare system’s ability, at the legal and policy levels, to keep up with increasing numbers of individuals grappling with mental health challenges and those seeking treatment. While the Peace Corps encourages full disclosure of an applicant’s medical history to consider their health needs, the stigma and misinformation surrounding mental health make these issues harder to discuss despite the increase in mental health conditions among adults. Potential rejection from opportunities, relationships, jobs, etc. can make people fearful of being honest about their histories with mental health challenges. Therefore, the Peace Corps may see a decrease in support and applications as these health screening policies continue to alienate potentially qualified and motivated volunteers.