On October 10, 2018, Liveyon LLC (“Liveyon”), a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, California, announced that it voluntarily recalled all ReGen Series® products due to reported possible adverse reactions. The announcement stated, in part: “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 Center for Biologics Evaluation and Research (“CBER”), a division of the Food & Drug Administration (“FDA”), which oversees human cells and tissue-based products, contacted Liveyon on Thursday, September 28, 2018. CBER stated concerns related to the products manufactured by Genetech and informed Liveyon of reported possible adverse reactions due to the use of the ReGen Series® product. Liveyon immediately suspended shipment of all product pending an inquiry by CBER into the source of the adverse reactions. In addition, Liveyon voluntarily recalled any Genetech products it may have distributed.
In announcing the recall, Liveyon stated that it “immediately discontinued the purchase any product from Genetech and has procured new product from an alternative manufacturer. Liveyon has secured a manufacturer which has been in business for more than 15 years and manufactures the new product in a cGMP compliant facility … Liveyon will resume distribution of the new product line effective Monday, October 8, 2018.”
The recall was initiated on September 28, 2018, and “Consignees were instructed to not use the vials, due to reported adverse reactions.”
Meanwhile, the public remains in the dark about the recall: the recall notice fails to identify/describe the “adverse reactions,” whether those people suffering adverse reactions required hospitalization, or how many people suffered adverse reactions and their ages. So, how useful was the recall notice to the public?
Liveyon describes itself as “the exclusive worldwide distributor of a regenerative medicine product that is derived from umbilical cord. This product contains cells, stem cells and growth factors which may serve as a therapy for various degenerative diseases/disorders. Stem cells and cell based therapies have shown tremendous promise; yet controlled studies are still needed in order to confirm its efficacy. Professional judgment and expertise is needed in using these therapies for any therapeutic use, and we urge anyone embarking on the use of stem cell therapies or any regenerative medicine product to consult the national health data bases to evaluate current information from clinical trials.”
If you or a loved one suffered injuries (or worse) as a result of stem cell therapy in the United States, you should promptly seek the legal advice of a product liability lawyer in your state who may investigate your stem cell claim for you and represent you in a claim against a stem cell company, if appropriate.
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