EUCYT Labs, Maker of VidaCord, VidaGel, VidaStem, COVIXO and XOsomes, Receives Stern Warning from FDA
Injured or Crippled because of Defective Stem Cell Products from Eucyt Labs? You May Be Entitled to Compensation
EUCYT Laboratories is a stem cell company located in La Vegas. They sell a wide variety of products made from human umbilical cord blood, amniotic fluid and exosomes. Last year the company’s exosome product, XOsomes, was linked to several serious health complications of patients in Nebraska. Some of those patients reportedly developed sepsis.
State officials in Nebraska last year issued a warning after people receiving Eucyt’s products. According to the Nebraska Department of Health and Human Services.
“Recent events in our state and others have highlighted the risks to patients treated with unapproved stem cell, placental and umbilical cord blood-derived products. A recent incident involved individuals treated in Nebraska who became ill after receiving a product derived from C-section placentas, a subset of whom became bacteremic. The FDA recently issued a warning regarding unapproved products derived from stem cells.1 Today, the FDA has issued a patient safety notification warning of risks associated with products derived from stem cells and placentas, especially a product termed exosomes.2 These therapies are administered through intravenous injection, inhalation, or injection into joints or soft tissue. Nebraska DHHS continues to actively assess this situation along with our federal partners at the FDA and CDC.”
That product was XOsomes.
Less than a year later EUCYT is again in trouble.
On June 4th, the FDA issued a stern warning letter to the company. Apparently, the company is now trying to market its products as a cure for the novel coronavirus without any FDA approval and without proof that the product works.
According to the FDA, “Most recently, you began marketing an exosome product, COVIXO, for the treatment or prevention of patients’ Coronavirus Disease 2019 (COVID-19).”
Products made from human cells or tissues are subject to regulation by the FDA. The government wants to know the products are safe, effective and only marketed for approved purposes.
Not only is EUCYT marketing a product that hasn’t been proven safe or effective, the manufacturing facility where the products are made has serious life safety concerns.
“.. [D]uring the inspection, FDA investigators documented evidence of significant deviations from current good manufacturing practice (CGMP) and current good tissue practice (CGTP)… The deviations in manufacturing processes observed as well as those noted in documents collected during the inspection indicate that the use of your products raises potential significant safety concerns. For example, EUCYT’s deficient donor eligibility practices, unvalidated manufacturing processes, deficient environmental monitoring, and inadequate aseptic practices, as described below, pose a significant risk that your products may be contaminated with viruses or microorganisms or have other serious product quality defects.
Additionally, there have been reported safety concerns with one of your products.”
Each of those violations are very serious.
Often a patient will have his or her stem cells harvested for later use during or after surgery. If handled under sterile conditions, that process is relatively safe.
EUCYT uses stem cells from donors but apparently couldn’t document those donors met eligibility requirements. For example, donors were not screened to insure they did not have Zika virus (or other communicable diseases) which could be transferred through their products.
The FDA also found during an inspection that the company’s manufacturing practices couldn’t guarantee their products were sterile. In fact, the FDA didn’t find evidence of any controls to ensure that its products had the identity, strength, quality, and purity as advertised.
There were also no records for cleaning of equipment used in processing or packaging. The Company says it cleans its equipment but maintains no logs and has no formal process for how cleaning and sterilization takes place. (While the FDA was inspecting EUCYT’s plant, they observed workers cleaning a cutting board used for processing umbilical cords being “cleaned” in an eye wash station!)
The FDA says the company had at least 152 sterility failures including contamination with Acidovorax temperans, Clostridium perfingens, Enterococcusm faecalis, Escherichia coli (better known as the E. coli), Gram positive cocci, Gram negative rods, Klebsiella pneumonaie, Kocuria varians, and Streptococcus. Despite these failures, there was no documentation of corrective or preventative measures.
When the facility knew they had an E. coli problem they failed to test all product batches made that same day. Later a patient tested positive for the deadly E. coli after having received product from one of the untested batches.
The FDA says the company didn’t even keep proper complaint records. We wonder why EUCYT Labs even remains in business.
Since we began investigating and prosecuting stem cell injury cases, we have run into several companies pushing dangerous products on the unsuspecting public.
Worse, many of these same products don’t even work. Many companies freeze dry their product which effectively kills all the live stem cells.
The FDA specifically cited EUCYT for claiming its products are effective treatments for or prevent COVID-19.
Stem Cell Personal Injury Lawsuits
Not all stem cell products are bad. Unfortunately, the industry is going through what we call the “Wild West” phase. There are some legitimate companies that are careful in both their manufacturing processes and their claims. Others are nothing more than garage operations backed up by a slick website and outrageous marketing claims.
If you are hurt because of a bad stem cell product, the injuries could be permanent, life threatening and sometimes fatal. We don’t know much yet about EUCYT but in our experience, many of these smaller companies have little or no insurance.
Fortunately, in many states we can pursue the doctors, chiropractors and others that peddle these products. Whether these doctors were naïve or just plain greedy doesn’t matter. Most doctors and clinics have good insurance.
If you or a loved one was hurt after being prescribed a stem cell product, we can help.
For more information on stem cell therapy, visit our cornerstone post on stem cell lawsuits. In a constantly updated post, we list the history of stem cell therapy, what companies are registered with the FDA, questions you should ask your doctor and how to spot a scam.
Interested in learning whether you have a case and want to get reimbursed for your pain, suffering and medical bills? Contact us immediately. Although most states give injured parties several years to file claims for defective products, we worry that many of these companies have little insurance. Typically, the physicians, clinics and chiropractors that inject these products are better insured but many states require claims against doctors be filed within just 1 or 2 years from the date of injury.
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 brian@mahanylaw.com, by phone at 202-800-9791, or online. We consider cases nationwide. No legal fees unless we are successful recovering money on your behalf.
The post EUCYT Latest Stem Cell Company in Trouble with the FDA appeared first on Mahany Law.