September 9, 2022

Partner Matthew Gurvitz has been recognized by The AmLaw Litigation Daily for recently securing a landmark decision in federal court that found the U.S. Food and Drug Administration (FDA) lacks authority to regulate a California clinic’s stem cell therapies.

Matthew and his co-counsel at Jones Day were honored among the runners-up for the Litigator of the Week accolade for obtaining a trial verdict on behalf of California Stem Cell Treatment Center (CSCTC) in a lawsuit brought by the FDA alleging the company’s stem cell treatments violate the Federal Food, Drug, and Cosmetic Act.

After a seven-day trial, Judge Jesus G. Bernal of the Central District of California ruled that that the defendants’ innovative surgical procedure that uses patients' own stem cells to treat a range of medical conditions does not fall under the FDA's regulatory jurisdiction, barring the FDA from prohibiting physicians from performing the stem cell treatment on their patients.

The ruling is significant for people seeking to utilize their own stem cells as part of medical treatment, firmly holding that the FDA lacks authority to regulate these personal stem cell treatments on the grounds that they do not qualify as “drugs” under the applicable FDA regulations.

Read more about the ruling here.

Read The AmLaw Litigation Daily “Litigator of the Week” article here (subscription may be required).

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