Is Utah Cord Bank Peddling Dangerous (and Ineffective) Stem Cell Products?
A Pittsburgh woman claims she suffered horrific injuries after being injected by a stem cell product called StemVive marketed by the Utah Cord Bank. Last month Marianne Cornetti filed a lawsuit against the maker of the product and the chiropractors office where she received the injection.
We have long warned about the dangers of stem cell products. Although the industry is still in its infancy, there is great promise for life changing therapies. Unfortunately, several products have received FDA approval for limited purposes, the marketplace still resembles the wild west. Some companies produce untested and poor quality products in garages while other companies make wild claims just like the traveling snake oil salesmen of the 1800s.
In this post we will share Marianne Cornetts story and then discuss how to separate the good companies from the bad and how to sue if you are injured by a defective stem cell product.
Mariannes story begins in May 2019 after she saw an ad for stem cell injections. The business behind the ad campaign was Verri Chiropractic Associates and its owner, Dr, Frank Verri. She attended a seminar sponsored by the chiropractic office and the Utah Cord Bank. During the seminar she heard that stem cell injections could be used as a treatment for arthritis.
She says that seminar promoted a product called StemVive. The seminar touted the safety, efficacy, approval and certification of the product, for the treatment of degenerative joint disease including arthritis.
Marianne became a patient of Dr. Verris clinic. On May 14th, she received multiple stem cell injections in both knee joints. The injections were either made or sold by Utah Cord Bank and were administered by a nurse practitioner.
What is unusual is that a representative of Utah Cord Bank was present for the injections.
Marianne says she was told the StemVive product contained viable stem cells, that the product would grow stem cell colonies, that the cell forming properties of the product exceeded the capabilities of her own bone marrow, that the FDA had approved the product for the treatment of degenerative joint arthritis and that the product was safe. According to her lawsuit, all of those claims are false.
Shortly after receiving the injections, Marianne says she suffered from a wide variety of side effects including:
There are several interesting twists to Mariannes complaint.
First, the stem cell advertisement and subsequent seminar were sponsored by a chiropractor. Depending on the state, in many locations advising patients on stem cell therapies is outside their scope of practice.
Despite our belief that stem cells should only be prescribed by a medical doctor, many chiropractors have jumped on the stem cell bandwagon and see the product as an extra revenue source.
We believe that Marianne was pressured to sign up while attending a seminar. If I have arthritis, my doctor doesnt invite me to a seminar. We meet her in office, discuss options and agree on a treatment plan. Because many insurances dont pay for non-FDA approved treatments and products, stem cell hucksters use seminars as a way to woo new patients into forking over thousands of dollars in return for a miracle cure. Its also probably why a representative of the Utah Cord Bank was present when she was injected; many of these seminars are high pressure meaning they want patients to sign up and pay immediately before they change their mind.
If the patients are lucky, they just lose their money. If they are like Marianne, they have permanent disabling injuries.
Next, Marianne sued not only the Utah Cord Bank but also Dr. Verri, his chiropractic office and the nurse practitioner who did the actual injection. In our experience, many garage based stem cell makers and distributors dont have much in the way of insurance. Physicians, healthcare clinics and nurses, on the other hand, usually have good liability insurance.
Finally, Marianne says the stem cell products werent viable. We agree and that is a huge problem. To get the benefits of live stem cells, they must be living. Many companies, however, sell freeze dried product. If it was flash frozen, any living cells are dead.
An expos from a competitor said the product they obtained from Utah Cord Bank was frozen. It shouldnt be surprising then, that the StemVive sample had no active colonies.
In May, 2019, the New Yorker ran a story that claims two former employees of the Utah Cord Bank says the company used expired chemicals and reagents in their lab. The company denied those allegations.
Because the lawsuit was just filed, we dont know how any of the defendants will respond. Utah Cord Banks website claims, We Change Lives. If you ask Marianne Cornetti, the change she experienced is not very good.
Some stem cell products have received FDA approval and are already on the market. Others have obtained an FDA investigational new drug designation. According to the National Institutes of Health (NIH), more than 1,000 clinical trials examining stem cell therapies are currently underway.
All manufacturers of FDA-regulated stem cell products must adhere to strict FDA safety guidelines regarding manufacturing practices to ensure safety, potency, and purity. Patients injured by contaminated products have the right to file a stem cell lawsuit for financial compensation, including money to pay for past and future medical expenses, lost wages, pain and suffering, and other damages. (If a patient receives dead cells or if the company selling the cell products makes inaccurate claims about the effectiveness of its products, you may also have a claim.)
Since properly prepared stem cell therapies rarely cause serious complications, you may be eligible to file a stem cell lawsuit if you suffered serious injury due to a stem cell product.[See our contact information at the end of this post.]
To meet FDA current good manufacturing practices (cGMP) requirements, stem cell companies must maintain a sterile facility to prevent risk of contamination. Live stem cells must be irradiated to ensure no bacterial or viral contamination is present.
Many stem cell products are manufactured overseas, making efficient FDA regulation difficult. With an FDA staffing shortage, overseas stem cell companies arent worried about surprise inspections and often fail to maintain a sterile facility or have proper quality control testing.
The dangerous products lawyers at Mahany Law are interested in hearing from anyone who has experienced serious complications after stem cell therapy.
Working with our national network of dangerous drug lawyers, we can help you receive answers and compensation. Stem cell products may be the future of modern medicine. Unfortunately, there are far too many companies rushing into the field with untested or dangerous products and making wild claims of miracle cures.
To learn more, visit our Stem Cell Injury Lawsuit page. Ready to see if you have a claim for your injuries (or if you are an insider with information that can help patients) contact us by email at *protected email*, by phone at 202-800-9791, or online.
All inquiries are kept strictly confidential. Cases handled on a contingency fee basis meaning no fees unless we win and recover money on your behalf.
Go here to read the rest:
New Stem Cell Injury Lawsuit Filed StemVive & Utah Cord Bank
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