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FDA/DOJ Suit Against Florida Stem Cell Clinic Heads For June 10 Trial.

MIAMI, Fla., April 22, 2019 -- The FDA and Department of Justice (DOJ) are suing in federal court in Fort Lauderdale, Fla., to stop U.S. Stem Cell's untested and unapproved stem cell treatments in an aggressive action against the burgeoning stem cell business.

FDA/DOJ have requested a permanent injunction against the company.

The parties in the suit have acknowledged mediation has failed and have agreed to advance to a bench trial on June 10.

However, attorney for the defendant, Isaac J. Mitrani, asked for a delay because June 10 is a Jewish holiday (Shavuot) and on subsequent days he would be attending a son's graduation.

Judge Ursula Ungaro denied the request for a delay, noting that the defendants have plenty of attorneys on their side who could handle the matter in court.

The most recent motion filed by the plaintiffs on April 19 asked that the court not allow "anecdotal" testimony from the defendants about the safety or effectiveness of U.S. Stem Cell treatments.

According to the motion filed April 19:

"Because anecdotal testimony related to safety or efficacy of Defendants' SVF product will not resolve any factual or legal matter at issue in this case, and because such testimony will inevitably lead to a waste of time and resources, such testimony should not be allowed at trial."

As of this writing (April 22) the Judge has not responded to the plaintiffs' motion.

The FDA/DOJ suit alleges that U.S. Stem Cell of Sunrise, Fla., is "openly violating the law and endangering patients."

The suit was filed May 9, 2018, in the U.S. District Court for the Southern District of Florida (USA v. U.S. Stem Cell).

A victory by the government plaintiffs could severely hamper the unchecked growth of stem clinics selling expensive but potentially worthless and even dangerous stem cell therapies for a wide variety of conditions.

Clinics offering such therapies have been accused by doctors, lawyers, and federal officials of harming dozens of people.

Thanks to previously slow and somewhat feeble response from the FDA, U.S. Stem Cell continues to operate four years after the first reports of blindness caused by stem cell injections into the eyes of several patients.

The company stopped injecting its fat-derived treatments into eyes after patients sued.

But it continues to sell the therapy to people with spinal injuries, Parkinson's disease, multiple sclerosis and other serious chronic conditions.

According to the Washington Post report:

"Last spring, just three weeks after the government filed suit, another patient had a catastrophic reaction after visiting a South Miami clinic affiliated with U.S. Stem Cell. The 59-year-old woman felt faint and started vomiting two hours after receiving injections for arthritis pain.

"Her case--which has not previously been reported --was described in an 'adverse event' report filed with the FDA and obtained by The Washington Post through the Freedom of Information Act, as well as in a second report filed with the Florida Health Department. The woman was taken to a hospital and spent more than a month in a coma, the reports said."

...

"With $6.7 million in revenue last year, U.S. Stem Cell operates three clinics and has trained doctors at 150 others, making it one of the most influential stem cell companies in the nation. Over the past year, it has hired a top law firm to defend against the lawsuit, and cultivated formidable allies with close ties to President Trump, including GOP operative Roger Stone and Newsmax chief executive Christopher Ruddy."

And, The Niche, a stem cell blog published by the Paul Knoepfler Lab, wrote on March 10 that the FDA/DOJ and U.S. Stem Cell, "have agreed on something!"...

"According to new court records... they have both given up on mediation in the federal lawsuit."

[Editor's note: Paul Knoepfler is a biomedical scientist, science writer, advocate, and cancer survivor. He is a professor at UC Davis School of Medicine in the department of cell biology and human anatomy. To read the entire Knoepfler blog entry ("Clinic biz U.S. Stem Cell may be kaput in matter of weeks or months"), visit:

http://bit.ly/2Ucz942]

[Editor's note: To read the extensive Washington Post article ("This Clinic's Experimental Stem Cell Treatment Blinded Patients. Four Years Later, The Government Is Still Trying To Shut It Down") by Laurie McGinley and William Wan, April 3, 2019, visit:

https://wapo.st/2Z7XFqE ]
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Title Annotation:FDA Regulation
Publication:Stem Cell Research News
Geographic Code:1U5FL
Date:Apr 22, 2019
Words:734
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