U.S. v. California Stem Cell Treatment Center et al.

Seeking to halt doctors from administering patients' own stem cells to their bodies as a therapeutic treatment, the U.S. Food and Drug Administration, in an enforcement action, contended that the procedure was actually the unlawful manufacture of a drug.

Pushing back, a team of Jones Day and Wilkie Farr & Gallagher LLP lawyers -- all of whom had worked at Venable LLP when the case originated -- persuaded a federal judge to reject the government's arguments, deny its bid for an injunction and hold that the FDA had overreached its authority.

"Enforcement actions rarely go to trial because people are afraid of the government," said Jones Day partner Celeste M. Brecht who led the defense aided by colleague Ramanda R. Luper and Wilkie Farr & Gallagher LLP's Matthew M. Gurvitz. All began the case when they worked at Venable LLP. "But our clients firmly believed in what they had been doing for 40 years."

The stem cell treatments were not drug manufacturing, but rather medical procedures, ruled U.S. District Judge Jesus G. Bernal of Riverside. U.S. v. California Stem Cell Treatment Center et al., 5:18-cv-01005 (C.D. Cal., filed May 9, 2018).

"We had the facts and the law on our side," said Brecht.

U.S. Department of Justice's Roger J. Gural, who led the plaintiff team, did not respond to a message seeking comment. The government has challenged the outcome at the 9th U.S. Circuit Court of Appeals.

The FDA sued both the California Stem Cell Treatment Center and a similar defendant, U.S. Stem Cell Clinic LLC, in Florida. It won summary judgment at the trial court in Ft. Lauderdale and affirmance at the 11th Circuit. If the 9th Circuit upholds Bernal's ruling, the resulting circuit split could end up at the U.S. Supreme Court.

"One advantage to us is that we had a full two-week trial with witnesses and extensive findings of fact, whereas, in Florida, it was a summary judgment without a full factual record," Brecht said.

At the trial, a key witness for the defense was Lola M. Reid, a leader in stem cell research. "A fascinating woman and a pioneer in the field," Brecht said. She was especially effective because she had had a stem cell procedure performed on herself to repair a knee injury and avoid knee replacement, the lawyers said.

"Judge Bernal made key findings based on Lola Reid's very credible testimony," said Brecht's colleague, Ramanda R. Luper.

Defense team member Matthew Gurvitz of Wilkie Farr & Gallagher LLP said, "This was truly a landmark decision with significant implications, especially for people seeking to utilize their own stem cells as part of medical treatment. The ruling also allows physicians the autonomy to determine whether stem cell treatment is in the best interest of their patients without the FDA claiming they are manufacturing illegal drugs."

--John Roemer