A stem cell/regenerative clinic firm called the Lung Institute is facing a filing of a proposed class action suit. Update: Note that this firm also goes by the name the Lung Health Institute and now as of 2019-2020 it does not appear to offer stem cells anymore, perhaps focusing on PRP. You might also find this WaPo article from 2019 useful:‘I’d need a drink’: WaPo deep dive on clinic firm Lung Health Institute.
Is it possible that a growing number of lawsuits against stem cell clinics could freeze or reverse the growth of the clinic industry that sells unapproved medical therapies? If so, then it would achieve what so far the FDA hasn’t.
Both in the public domain and through the grape-vine I’m hearing that there are a growing number of attorneys zooming in on stem cell clinics.
Here in California a law firm is advertising a potential class action suit against one or more stem cell clinics. Details remain sketchy so far.
“In 2014, Rivero took out a home equity loan to pay $7,500 and traveled from her western North Carolina home to Florida to undergo stem-cell therapy at the Lung Institute in Tampa. The institute claimed she would see results in a matter of weeks, according to a lawsuit Rivero filed last week.
Instead, according to the suit, she got worse. Now Rivero, 58, is the first of what her attorney says are dozens of former patients seeking class-action status in a legal action against the institute.”
The Times piece goes on to describe the heart of the case:
“Rivero’s suit says the Lung Institute violated Florida’s Deceptive and Unfair Trade Practices Act by duping clients into believing stem-cell therapy worked despite the absence of credible medical evidence.
“It’s one thing for folks that have an incurable disease to try experimental treatments,” said Rivero’s attorney, Ben Vinson Jr. of Tampa. “But it’s another when the person offering the treatment knows it doesn’t work.”
The Lung Institute was quoted as indicating that they believe the current case has no merit:
“Speaking for the institute, Lynne Flaherty Margnelli, executive vice president of Regenerative Medicine Solutions, said in a statement to the Tampa Bay Times: “Lung Institute prides itself on putting patient care first and always operates with the patients’ best interests in mind. We do not believe the case has any merit and we look forward to resolving this matter.”
Of course, in cases like this the clinics are simply alleged to have done certain things and are innocent unless proven otherwise. The cases do shed interesting light on the stem cell clinic industry though.
The Times also included this interesting information:
“A 2015 Times story said there is little evidence that the institute’s treatment works for patients with incurable lung conditions such as chronic obstructive pulmonary disease, or COPD.
Dr. Burton Feinerman, who was medical director at the Lung Institute when the Times story ran, said then that the American medical establishment is too slow to embrace developments.”
As a stem cell biologist myself, I’m not aware of solid evidence that stem cells of this kind could effectively and safely treat lung disease. To me this kind of use also sounds like it would likely be non-homologous use, and if so that would make the stem cells a biological drug seemingly requiring pre-approval by the FDA.
More generally, stem cell clinics are thought to generate large amounts of money and this issue came up in the Times piece as well:
“According to the suit, the cost of the procedures ranged from $5,000 to $12,000. The suit claims the institute, which occupies a fourth floor of a downtown Tampa office building, brings in at least $2 million a month.”
This financial claim may or may not be accurate, but that would add up to $24 million per year for just one stem cell clinic out of more than 500 in the U.S. today. Also of interest is if you figure the average cost based on this quote might be around $8K-$10K, then if these numbers are accurate that means that this clinic has around 200 stem cell customers a month. That sounds awfully high.
Do you know of any other cases of stem cell lawsuits?