Government Agencies Cracking Down on Unapproved Use and Marketing of Stem Cell Injections
Posted On behalf of Pfeifer Morgan & Stesiak on Jul 07, 2021 in Personal Injury
The U.S. Food and Drug Administration (FDA) says it will broadly enforce requirements that developers of stem cell injections, and other regenerative medicine products, follow the proper approval rules for new drugs. As hundreds of businesses continue to sell the unapproved therapies, the Federal Trade Commission (FTC) is also working to crack down on what they call deceptive marketing practices on the Internet and social media.
If you were marketed to and received stem cell injections, and then later had an adverse reaction to the treatment therapy, you may be able to pursue compensation from several parties.
Our consumer protection lawyers are prepared to review your claim and see what legal options may be available to you if you suffered an injury after being sold stem cell injections as a cure-all treatment.
We offer a free consultation to discuss your claim and there are no fees while we work on your case. If you choose to hire us, you only pay us if we successfully recover compensation on your behalf.
What Are Stem Cell Injections?
Stem cell injections are a medical procedure often advertised as a cure-all treatment by some medical clinics. These clinics claim stem cell treatments work by using the body’s own healthy stem cells to regenerate and repair damaged or diseased cells in your body.
It is a fact that stem cell therapies may offer potential treatment for diseases or illnesses that do not currently have any existing cures or treatments. However, the FDA stresses that it is concerned about patients who are desperate for a cure to their ailments who may be vulnerable to stem cell treatments that are illegal and may cause serious health issues.
Is Stem Cell Therapy FDA Approved?
In 2020, the FDA issued a warning about regenerative medicine products, including stem cell injections, saying:
“Stem cell products are regulated by FDA, and, generally, all stem cell products require FDA approval. Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the “hematopoietic” system) but they are not approved for other uses.”
This means that clinics claiming they use FDA-approved therapies are not being honest since there is only one genuinely approved use of stem cells in the U.S. and it does not include using it to treat ailments like back or neck pain, Parkinson’s Disease, Autism and other illnesses many of these clinics claim to cure.
Concerns About Health Risks After Stem Cell Injections
Between 2004 and 2020, there have been at least 360 cases of people who have suffered injuries or death after undergoing stem cell injections. Although this number may seem low during the span of nearly 20 years, it is important to note that adverse results from these injections are vastly underreported by medical professionals and patients alike due to their non-FDA approved status.
The Pew Charitable Trusts gathered reports of adverse events linked to unapproved stem cell injections and other regenerative drugs that were administered outside of clinical trials. The results include:
- 334 cases which were documented in peer-reviewed journals, government and media reports, and other literature.
- Five cases that were reported to the FDA’s adverse events reporting system (FAERS)
- 21 cases documented by consumer reviews of stem cell businesses (such as clinics) that were posted to Google, Yelp and Facebook.
In 2018, 12 patients from three states, Arizona, Florida and Texas, all suffered from different types of infections including bloodstream infections, joint infections and epidural abscesses after receiving stem cell injections that had been contaminated with E. coli and E. faecalis, according to a report from the Centers for Disease Control and Prevention (CDC). The bacteria-contaminated injections had all been processed by a company called Genetech, Inc. and distributed by Liveyon, LLC. In 2019, the injury victims filed a class action lawsuit against the two companies, which was eventually settled out of court.
Why Are Stem Cell Injections Still Being Marketed?
In October 2018, the FTC filed a complaint against Dr. Bryan Jarald Henderson, D.O. and two companies he owns (Regenerative Medicine Group and Telehealth Medical Group) alleging deceptive marketing practices that its “amniotic stem cell therapy” could treat serious diseases, yet lacked the scientific evidence needed to support their claims. In 2019, Dr. Henderson settled with the FTC and nearly $515,000 was returned to consumers who had fallen victim to their deceptive advertising.
Despite the 2019 settlement, clinics continue to employ direct-to-consumer marketing practices through website blogs and social media posts to promote their stem cell injections, a strategy the FTC and the FDA both say they will now be cracking down on.
The problem is that stem cell therapies may offer potential benefits to treat ailments, but a lot more research needs to be done before the FDA can give the green light to this next generation of medicine. This makes it difficult to entirely stop all marketing practices. Instead, the FTC says it will work to stop advertisements that promote the product as a cure-all. The FDA continues to issue warnings about the risks associated with the experimental therapy and asks consumers to ask questions and be skeptical of any drug touted by medical professionals as a cure-all.
You May Have Legal Options. Call Us Today
If you suffered an adverse reaction to an experimental stem cell injection after being told it would cure your ailments, you may be able to pursue compensation for your medical bills, lost wages and other damages.
Previously settled cases with product manufacturers, distributors and clinics that falsely advertised the treatment as a cure-all set a precedent for injury victims like you who want to see these companies held accountable for their lies and deceptive practices. Unfortunately, it may be a difficult process to navigate on your own, especially if your injuries are severe or you lack legal knowledge and experience.
At Pfeifer Morgan & Stesiak, our attorneys have decades of combined experience fighting for the rights of injury victims in Indiana and have the legal knowledge to help build a case to hold companies that violate consumers’ rights accountable.
We offer a free consultation to discuss your claim with a member of our legal team, and there are no fees while we work on your case.
Call us today at (844) 678-1800.