Recently, a Florida jury found the Tampa-based Lung Institute guilty of engaging in deceptive and unfair practices when it provided patients with ineffective stem cell therapies to treat incurable lung diseases. This nearly decade-long class action led the defendant to pay US$9 million (£7 million) to its former patients. This is probably one of the costliest sums awarded against a stem cell clinic in US history.
Stem cell research is regarded as a holy grail for treating a number of diseases. However, much work is needed to translate the research into safe and effective therapies. At present, the extent of diseases for which there are proven therapies based on stem cells is limited and the only proven safe and effective stem cell therapy is haematopoietic stem cell transplantation.
The action here was based upon false and material misleading statements and omissions by the Lung Institute about consumer satisfaction with the stem cell treatments on its website. The site stated scientific studies and patient testimonies as evidence that they provide effective stem cell procedures that could manage chronic obstructive pulmonary disease (COPD).
In 2016, Tammy Rivero began her legal battle against the clinic. As a smoker, she was diagnosed with lung disease and complained of breathing problems. The clinic (which has since changed ownership) advertised procedures that promise to regenerate, repair or regrow lung tissues and heal degenerating organs. The process involves extracting the cells from the patient's blood and reintroducing them into the body via an IV. Rivero paid $7,500 for these treatments, but unfortunately, they did not work, she told WPTV.
As Rivero was not the only patient, and more than 1000 others were in a similar situation seeking compensation, a judge certified her class action legal suit against the Lung Institute. According to court documents, the plaintiffs alleged that the company misrepresented the efficacy of the treatments they offered.
A class action is where numerous claimants have claims arising out of identical or similar circumstances; the plaintiffs bring this suit on their behalf and the representatives of the other similarly affected members. It is brought as there is a well-defined community of interests in the litigation in which common issues predominate over any questions that affect only individual class members. So, the class is enormous, making getting all its members before the court impracticable. A major advantage of a class action is saving time and money. Justice delayed is justice denied. Moreover, it avoids the need for a judge to decide common issues of fact and law more than once, permitting disputes involving many plaintiffs to be resolved in one case, a significant aspect of case management of civil litigation.
An esteemed global stem cell organisation, the International Society for Cell and Gene Therapy (ISCT), commended this court decision. Some of the ISCT Committee members on the Ethics of Cell and Gene Therapy, Professor Leigh Turner, Dr Laertis Ikonomou and Dr Daniel Weiss, served as pro bono expert witnesses for the plaintiffs. They performed in their individual capacities and not on behalf of ISCT.
These experts also contributed to a recently published guide that provides the medical profession with important information and guidance to discern legitimate treatments from untested ones and identify marketing practices adopted by commercial entities that offer these unregulated stem cell procedures. The ISCT stated that the court judgment sends a powerful message to the unscrupulous clinics operating without proper regulatory oversight, emphasising the need for strict conformance to high ethical standards and regulations.
It serves as a solemn reminder of the various risks posed by unregulated therapies and, thus, the need to shield vulnerable patients from misleading statements and ineffective stem cell therapies. Moreover, the court ruling is critical, grounded on deceptive advertising rather than medical malpractice. This parallels the Federal Trade Commission's actions and suggests a viable legal strategy to challenge the providers of unproven stem cell procedures, it reads.
It is noteworthy that this is not the first class action against a stem cell clinic. A few years ago, a class action against StemGenex in California (a now-bankrupt stem cell clinic) resulted in a legal settlement of US$3.65 million (£2.86 million), (see BioNews 1138).
Will this vast class action settlement deter other unscrupulous stem cell clinics? A study published in Cell Stem Cell found more than 2500 stem cell clinics in the USA in March 2021 and it remains to be seen whether more court cases deciding in favour of the plaintiffs could make a difference.
As one of the expert witnesses, Professor Leigh Turner, an ethicist from the University of California, Irvine told me recently: 'The verdict in favour of plaintiffs is significant, but it is unclear whether the jury's decision will have a significant effect on the large US direct-to-consumer marketplace of businesses selling unlicensed and unproven stem cell interventions. Fearful of the possibility of litigation by patients or action by regulatory bodies and law enforcement agencies, some businesses might decide to stop using deceptive marketing claims to sell purported stem cell treatments.
'Other companies might decide to continue making such claims on the assumption that the profits to be made from selling supposed stem cell therapies are considerable, and most misrepresentations do not lead to large-scale class action lawsuits or to substantial verdicts against such businesses.'
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