Patient: Shots in eyes left me blind

French woman’s lawsuit cites stem-cell treatment performed in Broward

U.S. Stem Cell Clinic in Sunrise — which has been in the spotlight after three women said they lost vision from stem cell injections in their eyes — is the target of another lawsuit.

A fourth patient, Jeannine Mallard, 68, who traveled to South Florida from France for treatments in February 2015, said she suffered a retinal detachment and blindness following eye injections, according to the lawsuit filed in Broward County on Dec. 12.

Unlike the other women, however, Mallard’s treatments were not performed at U.S. Stem Cell Clinic. The lawsuit says Dr. Shareen Greenbaum, a Cooper City ophthalmologist, treated Mallard at her Hollywood Eye Institute, using a procedure designed by U.S. Stem Cell Inc. and overseen by one of its executives, Chief Scientific Officer Kristin Comella.

Comella is named as a defendant in Mallard’s lawsuit, along with U.S. Stem Cell Inc., U.S. Stem Cell Clinic and Plantation-based Regenestem, a company that trains doctors and develops stem cell therapies. U.S. Stem Cell Clinic is a separate subsidiary of U.S. Stem Cell Inc.

In a written statement regarding the suit, U.S. Stem Cell Inc. said Wednesday that the company has trained “hundreds of doctors worldwide” on how to use the company’s technology and that “clinics have safely conducted thousands of stem cell procedures utilizing our protocol.”

Greenbaum did not return phone calls left at Hollywood Eye Institute.

The legal action against U.S. Stem Cell comes less than a month after the U.S. Food and Drug Administration asserted its authority over for-profit stem cell clinics, saying it would crack down on “bad actors” offering treatments the agency considered potentially dangerous — including those involving eye injections. The clinics have largely evaded regulation for years because they say the stem cells solutions they manufacture are not drugs, and therefore don’t require FDA oversight.

These treatments, offered at more than 100 forprofit stem cell clinics that have proliferated in Florida, have not been clinically proven to be safe or effective.

“I hope the FDA does take a more aggressive approach. For now, civil litigation is the only way to hold them accountable,” said Mallard’s attorney, Andrew B. Yaffa, who also represented two of the three other women who said they lost their sight following eye treatments at U.S. Stem Cell Clinic in June 2015.

Mallard’s treatment for macular degeneration took place just a few months before that, in February, and she paid $5,000 for injections in both eyes, the lawsuit said. For an extra $2,000, U.S. Stem Cell Clinic stored additional stem cells taken from her belly fat tissue, “because they told her she would likely need them for future therapies,” Yaffa said.

She had a retinal detachment following an injection directly into her right eye, which later went blind, the lawsuit said. That same day, she also had an injection behind her left eye, which caused severe vision loss.

U.S. Stem Cell treats an array of diseases, from multiple sclerosis to Parkinson’s, with stem cells drawn from a patient’s bone marrow or fat tissue.The clinic stopped doing eye procedures in June 2015, according to a statement U.S. Stem Cell released on Thursday.

That was the month the three women traveled to South Florida for macular degeneration treatment at U.S. Stem Cell Clinic. Two of them later sued, saying they had been led to believe they were part of a clinical trial, had retinal detachments following their procedures and were left almost blind.

Both women also said Greenbaum, who was a U.S. Stem Cell consultant back in 2015, was involved in their treatments. She was named as a defendant in their lawsuits. Both patients settled and have declined to discuss their cases.

The FDA sent a warning letter in August to U.S. Stem Cell Clinic, saying it did not have proper federal permits to offer its experimental treatments. Comella has said the clinic is not violating regulations but is continuing talks with the FDA.

U.S. Stem Cell and the FDA would not comment on the status of the warning letter or the discussions.

However, in a recent letter to the Sun Sentinel, Comella said “thousands of procedures utilizing U.S. Stem Cell Inc. technology have been performed, with very few adverse events.”

In the meantime, the Academy of Regenerative Practices, a stem cell clinic industry group, has started a legal defense fund. The forprofit academy has the same address as U.S. Stem Cell Clinic, and Comella is its president.

Information about the legal defense fund on the academy’s website says that not allowing patients to use their own cells as they choose could violate their constitutional rights. “Recently, the FDA has acted to limit the rights of patient to access their own tissue,” the site says. “We stand with the clinics that have come under fire and know we are on the right side of history.”

State officials said the academy is not currently registered with the Florida Department of Agriculture and Consumer Services to solicit contributions.

U.S. Stem Cell declined to comment on the legal defense fund.