Remember the Lung Institute? Many patients raised red flags about their experiences there. It was also once known as the Lung Health Institute.
More generally, patients who have been harmed by stem cell clinics have had to rely on other ways beyond the FDA to try to do something about it. The FDA has been largely inactive on this front for the past few years in terms of official actions. Also, patients tell me that the FDA never seems to follow up when they file complaints against specific clinics.
More practically, the FDA does not play a direct role in patients trying to get some of their money back.
For such reasons, personal injury lawsuits are a go-to option for some clinic victims. There have been many such cases and two major class-action suits, which may have the greatest potential impact. For example, Stemgenex here in California lost a big class action suit a few years back. Now there is news of a similar outcome in Florida.
Lung Institute found guilty
Here’s the news: Lung Institute found guilty of selling patients ‘sham’ stem cell treatment for incurable lung disease, WPTV West Palm Beach.
The sub-header notes the marathon case and huge verdict: “Nearly decade-long class action nets more than $9 million verdict for consumers.” I honestly thought this one may never be resolved so this is unexpected, good news.
The case was centered on the Tampa Lung Institute clinic:
“A Tampa jury recently found the now-defunct Lung Institute in Tampa guilty of engaging in “deceptive or unfair practices” while it offered customers “valueless” stem cell therapy to treat incurable lung disease.”
The article also reports there are about 1,000 patients involved in the suit. Each will receive anywhere from a few thousand to $30,000 from the verdict.
There is no good evidence in my view that stem cells, PRP, or other similar biologics can help lung diseases. See Stem cell therapy for COPD: challenges & hope for background.
The big picture
Like Stemgenex, the Lung Institute is reportedly now bankrupt. This raises the question of accountability as does the very long time frame here. Do these bankruptcies mean less money for harmed consumers?
Also, hundreds of other unproven clinics continue to operate. When they are sued or otherwise challenged, the clinics or their attorneys start backtracking and making excuses. From the news article on the Lung Institute case:
“While neither the Lung Institute nor its attorneys have responded to our repeated requests for comment about the verdict, in closing arguments, attorneys tried to argue they weren’t required to tell customers they didn’t conduct clinical trials to prove their treatments worked. Attorneys also argued that customers signed waivers consenting to their treatments.”
Circling back, again a big part of the problem here is the FDA.
They have failed to properly oversee the unproven biologics sphere for more than a decade now. More people have gotten hurt and ripped off as a result.
As I wrote last week, to my knowledge the FDA Commissioner Robert Califf hasn’t even said (or Tweeted or written) a word about stem cell clinics. There was also a news article recently in which FDA officials were quoted as saying that consumers who feel harmed by clinics should turn more to states for action.
While lawsuits like this latest class action suit and actions by state AGs can have positive impact, they are no substitute for oversight by the FDA. State medical boards have also generally failed to address stem cell clinic doctors in their states, even after complaints are filed.