Can civil lawsuits stem the tide of direct-to-consumer marketing of unproven stem cell interventions

Abstract

The sale of unproven stem cell interventions (SCIs) by commercial entities has proliferated in highly developed countries, most notably in the USA. Yet, there have been few criminal prosecutions and regulatory enforcement actions against providers who have violated laws and best practice standards due to the lack of resources and legal ambiguity. While the stem cell research community has invested much in protecting patients and preventing the growth of this industry, some patients are seeking remedies under civil law to hold stem cell clinics responsible for fraudulent practices. Several patients have filed lawsuits against providers demanding compensation for physical injuries caused by unproven treatments and financial losses due to fraud and false advertising. Lawsuits can be used as a tool not only to compensate plaintiffs but also to achieve positive public health and policy outcomes. In this paper, we explore the value of a public health litigation strategy as a countermeasure against the exploitative practices of the unproven SCI industry by analyzing stem cell lawsuits and comparing them with other major public health litigation efforts. We argue that stem cell lawsuits complement other approaches to reining in unsafe practices. In particular, stem cell lawsuits could intensify publicity and raise awareness of the harms of unproven treatments, set legal precedent, reshape the media narrative from one focused on the right to try or practice to one highlighting the need for adequate safety and efficacy standards, and encourage authorities to turn their attention to policy reform and enforcement.

Ethical and Practical Considerations for Integrating Cellular (“Stem Cell”) Therapy into Clinical Practice

“…Achieving a balance that avoids overtly lax or strictly prohibitive regulatory measures over SCI has been a notoriously precarious aspect of legislation [40]. The marketing of uncharacterized and unproven SCI poses a controversy based on medical ethics [16,34].…”

“…Medical licensing boards could effectively curb the spread of the unindicated use of SCI through disciplinary actions ranging from issued warnings to revoking of licensure [16,34,43]. Civil litigation, including the aforementioned class-actions, could act as a deterrent against bland violations in the form of misrepresentation that invalidates informed consent [40]. The Federal Trade Commission (FTC) has instituted a campaign to halt the deceptive health claims by certain SCI businesses advertisement.…”

6. Sind menschliche zerebrale Organoide moralisch schützenswert? Ein kommentierter Überblick über die aktuelle internationale Ethikdiskussion

“…"Wild-West"-Manieren, wie sie z. B. bei einer ganzen Reihe von Stammzellanwendungen zutage treten, bei denen kommerziell geführte Kliniken nicht ausreichend geprüfte Stammzelltherapien an zahlende Patient*innen verabreichen, sind dabei unbedingt zu unterbinden (McLean et al, 2015;Sipp et al, 2017;Horner et al, 2018; siehe hierzu auch Besser et al, 2018).…”

Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions

“…A review of these results, consistent with previous analyses , indicates that administration of SCIs not subjected to proper testing, accepted manufacturing standards and clinical supervision can, at least in some cases, pose serious risks. While some of the injured patients sought legal action against providers offering unproven SCIs, most lawsuits have reached a settlement with no judicial decisions against these practices .…”