VANCOUVER, British Columbia, July 09, 2024 – The International Society for Cell & Gene Therapy (ISCT) commends the recent verdict in a landmark class action lawsuit against the Lung Institute, a provider of unproven cell-based therapies for patients with lung diseases. The case took place in Tampa, Florida, and the ruling, delivered last month, found the Lung Institute guilty of engaging in “deceptive or unfair practices” while offering “valueless” therapies to customers.
This ruling is particularly noteworthy because it is grounded on deceptive advertising rather than medical malpractice, which parallels some actions the US Federal Trade Commission has pursued and suggests a viable legal strategy to challenge providers of unproven and unregulated therapies.
This verdict sends a powerful message to other clinics operating without proper regulatory oversight, emphasizing the need for stringent adherence to ethical guidelines and regulatory standards. It also serves as a reminder of the potential dangers posed by unregulated therapies and the imperative to protect vulnerable patients from misleading claims and ineffective treatments.
Leigh Turner, PhD, Laertis Ikonomou, PhD, and Daniel Weiss, MD, PhD, served as expert witnesses for the plaintiffs. While they acted in their individual capacities and not on behalf of ISCT, these individuals also serve on the ISCT Committee on the Ethics of Cell & Gene Therapy (ECGT) and contributed to a recently published guide that equips healthcare providers with the critical tools and knowledge needed to discern legitimate therapies from those that are unproven or unregulated, and to identify marketing tactics commonly employed by businesses that offer these therapies.
To further explore the implications of this case and discuss the future of regulatory practices in our field, the ISCT ECGT Committee will be hosting a webinar featuring key participants in the lawsuit. More details about this event will be shared shortly.
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