[Post updated April 2019 - IMPORTANT SETTLEMENT NEWS for patients suffering from side effects of ReGen stem cell products manufactured or marketed by LIVEYON LLC and GENETECH. This post has been updated to provide information about a possible settlement and how it may effect your rights.]
Stem cell therapy is the new frontier of medicine. The scientific technology already exists to guide stem cells into becoming specific cells that can be used to repair diseased human tissues. Patients who can already benefit from stem cell therapy include those with type 1 diabetes, Parkinson’s disease, certain spinal cord injuries, cancer, heart disease and strokes. Breakthroughs are made daily about using stem cells to become new tissue for organ transplants.
While the media and some doctors extoll the virtue of stem cell therapy, some question how much is hype versus scientific fact. Certainly, the use of stem cells to treat leukemia, for example, has been around for a few years and now has plenty of medical studies to bolster its effectiveness. Some other claims touting stem cells as a miracle cure are not as well established.
For patients there are two questions to ask, does stem cell therapy work and is it safe? We will leave the first question to the medical community to answer. Like any emerging science, the first few years will be confusing for patients and doctors alike.
Is Stem Cell Therapy Safe?
The answer is generally yes. Before we discuss the recall of Regen Series Stem Cell Products, however, let’s first define what a stem cell is and what experts say about the general safety of stem cell therapy.
According to the National Institute of Health, stem cells are cells found in the human body. They have the remarkable ability to develop into many different cell types in the body during early life and growth. Additionally, “in many tissues they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.”
Researchers were first able to isolate and grow stem cells in mice in 1981. It wasn’t until 1998, however, that scientists were able to derive stem cells from human embryos. And with that discovery the race for miracle cures was on.
But are they safe?
The Dana Farber Cancer Institute lists several side effects of stem cell therapy. The most serious, however, is indirect. It comes from “conditioning” that may have to occur before certain therapy such as that used for leukemia. That conditioning in cancer patients often means radiation and / or chemotherapy.
Getting the cells usually has no risk unless one contracts graft versus host disease (GvHD). That occurs when the transplanted stem cells view your body as foreign and begin attacking everything. It is an immune response that means the stem cells are working, except they are attacking both healthy and diseased cells.
Common side effects of GvHD include skin rash, fever, yellow discoloration of the skin or eyes, nausea, diarrhea, and cramping. GvHD often is often found in the liver and eyes. Doctors are getting better at predicting and preventing graft versus host disease through human leukocyte matching.
If you have GvHD, it doesn’t mean that something is wrong with the stem cell therapy you received. It is a reaction from the body.
Liveyon Recalls ReGen Series Stem Cell Product Made by Genetech
Liveyon LLC is the national distributor for stem cell products made by Genetech. The products are distributed under the trade name ReGen Series. Genetech makes their stem cell products in a laboratory based in San Diego.
On October 10, 2018, Liveyon issued a national recall of all ReGen Series stem cell products. The recall came on the heels of an FDA notification on September 28thindicating “possible adverse reactions due to the use of ReGen Series product.” Liveyon voluntarily elected to issue a national recall.
According to a press release issued by Liveyon,
“Working closely with the FDA, Liveyon has executed a strategic recall action plan and has immediately begun the voluntary recall process. The decision to stop shipment of Genetech products and implement the recall was to ensure the safety of all patients, regardless of whether the adverse reactions were product- related or the result of any procedural misuse of the product.”
The FDA operates a national reporting system for medical providers called the FDA Adverse Event Reporting System. Although designed for healthcare professionals and drug companies, consumers can also report adverse events. The FDA uses the system to early detect problems with certain drugs or products.
The FDA does not routinely specify the adverse reactions associated with a drug or medical product but does issue notices when a product is recalled or new warning are required because of adverse reactions. As of November 14 we have not yet received any information from the FDA on Regen Series products. We do have information, however, that there have been 19 adverse events out of a suspected 9000 injections. That figure is statistically significant because many adverse reactions are never reported to the FDA.
The FDA’s reporting system tries to differentiate between anticipated side effects and true adverse events. Without knowing the adverse events yet, it is hard to know what problems have been encountered. How large the impacts to patient safety are.
Making this more interesting, Liveyon’s website is now down. All pages simply say “coming soon.” An archived version of Liveyon’s site said the following about ReGen Series,
“Liveyon provides the industry’s highest-quality, independently screened and tested stem cells from an FDA-compliant lab. Liveyon is unique in that we use only the highest quality umbilical cord-derived mesenchymal stem cells (or MSCs). Highly efficient in differentiation, regeneration and anti-inflammatory and immunomodulatory effects, our MSCs offer multiple benefits for patient-focused treatments.”
Why all the mystery? How serious are the problems with Genetech’s ReGen stem cell therapy products? It is discouraging that no one is saying anything and that Liveyon’s website went virtually dark.
The only thing we can glean comes from their press release which says that Liveyon has “procured new product from an alternative manufacturer.” The release also says “the new manufacturer is a US-based, FDA registered, fully licensed and compliant umbilical cord blood/tissue bank accredited by the America Association of Blood Banks (AABB).”
The mysteries surrounding the recall are troubling. We do know, however, that manufacturers and distributors of defective medical products can be strictly liable for products that are dangerous, defective or adulterated.
Our concern with stem cell therapies is how they are made. Were they produced in a sterile facility? Are they adulterated? While stem cell products in general are safe, products that are contaminated, adulterated or non-sterile pose grave risks. This is especially true if they are being administered to people with a compromised immune system. (An example is a patient suffering from leukemia.)
We are not the only ones with such concerns. An October 4th blog post by Chris Centeno M.D., a specialist in regenerative medicine, offers additional insights. He says that although FDA registered, Liveyon’s ReGen Series product is not FDA approved.
He says that Liveyon claims its products suggest they contain live stem cells but that the “proof” they offer “isn’t worth the paper it’s written on.” Strong words!
Dr. Centeno shares our concern that the products made by Genetech are contaminated. In his words,
“If this is due to bacterial contamination, this has some very real risks. If this stuff is injected into a knee, the knee will likely develop septic arthritis (loss of cartilage due to the infection eating away at the joint). However, more concerning is that we have seen chiropractic and acupuncture clinics buying this stuff and injecting it IV. If one of these products ends up being given that way, this would lead to sepsis and possible death.”
He also says that some shady makers of stem cell products in an effort to say they offer “live” stem cells no longer irradiate and sterilize their products. That means they made contaminated with communicable diseases and other bio-organisms that can cause deadly infections.
That may be why Liveyon claims they are moving to a different manufacturer.
Were You Administered ReGen Series Stem Cell Products?
We are seeking people who have taken ReGen Series stem cell products made by Genetech and distributed by Liveyon and have suffered complications or adverse medical events. At this point, we remain in the early investigation stages as we acquire more information.
In the U.S. you have important legal rights and may be entitled to compensation for medical expenses, pain and suffering, future medical needs, lost wages and other damages due to contaminated or unsafe stem cell products. For more information, visit our dangerous drug and defective medical products page. Ready to see if you have a case? Contact us online, by email at [hidden email] or by phone at 800.669.7782. Cases accepted nationwide and are handled on a contingent fee basis meaning no fee unless we recover money on your behalf. In medical products cases, we frequently partner with other national law firms to prosecute these cases.
Are you a present or former employee of a pharmaceutical company? If you have knowledge of cGMP violations, adulterated products, unsafe medical devices or unreported adverse events, we would love to speak with you on a confidential basis. Our goal is always to put patients before profits. Thank you.
April 2019 Update:
Liveyon Offering to Settle ReGen Cases
Our Liveyon ReGen clients have begun receiving letters from a law firm to discuss settlement of their claims. Law firms are not supposed to communicate with represented parties but in fairness to the lawyers, if they don't know someone is represented, it is hard to follow that rule.
The lawyers representing Liveyon LLC, Wiley Rein in Washington D.C. and Beverly Hills Law Corp, are defense firms. They have been hired by either Liveyon or Liveyon's insurance carrier to defend the many claims against the company. We understand that 60 ReGen victims have been notified. There will probably be more as Liveyon attempts to identify patients hurt by their products.
If there is any silver lining here, it is that Liveyon has insurance. The company had previously assured that it was "well insured."
Before you get too excited, the silver lining is pretty tarnished. The lawyers in Beverly Hills say the company only has a total of $3 million in coverage and that they believe the policy only provides a maximum of $1 million for these claims. That isn't $1 million per patient, that is $1 million total. It get worse, Liveyon's lawyers get paid their defense costs first.
Let's do some simple math and see what that means for patients making claims.
If Liveyon's lawyers are wrong and the entire $3 million dollars is available and only 60 patients make claims (remember they are still looking for more), that means their is only $50,000 per person. Liveyon's lawyers are not working for free, however.
Lets assume they charge just $500,000. That is nothing to handle 60 cases. The pot becomes $2.5 million and each victim gets even less, just $41,666. This is assuming there are not more claims made.
Many of our clients are permanently disabled, must suffer a lifetime of pain and agony. Yet just $41,666?
If Liveyon's lawyers are correct, and only $1 million is available for all claims, that leaves just $500,000 for all claims after they pay their attorneys. The math on that becomes $8,333 per person. That is it!
Whoa! Don't give up hope, however.
We believe the doctors have liability. Depending on the state where the injections are administered, it may be possible to sue the physicians administering these defective ReGen stem cell products for either medical malpractice or products liability or both. Each case must be evaluated separately.
First, be careful of any release you sign. We don't want to see any patient waive their right to sue their physician because the executed a general release. Second, consider obtaining legal counsel immediately.
After we began suspecting that there might not be insurance for ReGen products, we stopped accepting cases. A million dollar policy with 60 claimants doesn't change our mind.
We are now willing to reconsider additional cases against the doctors on a case by case basis. The laws in each state vary tremendously. Physicians have been able to protect themselves from lawsuits in many states. If you were the victim of Liveyon ReGen stem cell products, call us.
And what about Genetech? They appear out-of-business. Calls are not returned. We are therefore assuming the worst, that is no assets and no insurance. We believe we have tracked down the owner of Genetech to a cell phone in Costa Rica, not a good sign. Once again, the only meaningful recovery may be from the physicians.
You have important legal rights and may be entitled to compensation from the physicians who administered Regen stem cell products. Your damages can include medical expenses, pain and suffering, future medical needs, lost wages and other damages due to contaminated or unsafe stem cell products. For more information, contact us online, by email at [hidden email] or by phone at 800.669.7782
Update: See our new cornerstone content on the safety of stem cell products and how to make a claim for compensation if injured because of unauthorized treatments or dangerous products.
*Genetech should not be confused with Genentech, a large international pharmaceutical maker also located in California.