ATLANTA - An Atlanta woman claims in a lawsuit that a stem cell eye therapy caused her to go blind.
The lawsuit comes at a time when the Federal Trade Commission and the Food and Drug Administration are cracking down on stem cell treatment centers across the nation.
Doris Tyler went into stem cell eye therapy with high hopes.
"I had macular degeneration and I can still see although blurry,” said Ms. Tyler.
After reading California Dr. Mark Berman's book, The Stem Cell Revolution, she thought she'd found the cure.
Dr. Berman runs the Cell Surgical Network with affiliated physicians all across the country. Doris Tyler picked the closest doctor to her Florida home. Peachtree City Dr. Jamie Walraven seen here on her Stem Cell Center of Georgia web page.
Doris Tyler claims in a llawsuitStem Cell Center of Georgia told her they could do the procedure and promised her there was nothing to worry about.
“The best would be my sight would improve, the worst was no change,” said Ms. Tyler.
In this clinic video, Dr. Walraven removed fat tissue from Doris's body. Filled with live stem cells.
Then later, Dr. Robert Halpern injected the stem cells into her right eye. The next day, the left eye.
Doris Tyler says she developed a detached retina in both eyes. Within three weeks she was blind in one eye. Two months later she was blind in the other eye. Her vision had gone from blurry to black.
“When I wake up in the mornings and open my eyes I still only see darkness. I know that's all I'm going to see all day,” she said.
Doris Tyler is not alone. A new England Journal of Medicine study found three other patients suffered "blinding visual outcomes" after stem cell injections in their eyes.
So, who is looking out for stem cell patients like Doris Tyler? It’s complicated, but it starts with the Food and Drug Administration and the Federal Trade Commission.
The Food and Drug Administration regulates stem cell therapies and calls it one of the most promising new fields in science.
But, FDA Commissioner Scott Gottlieb also warns consumers to beware of "unscrupulous actors" who use that promise to make deceptive, and sometimes, corrupt, assurances to patients based on "unproven" and "dangerously dubious" products.
Recently, the FDA filed a federal lawsuit against Dr. Mark Berman’s Cell Surgical Network seeking to stop his clinics from "experimenting on patients with adulterated and misbranded drugs."
Dr. Berman told me it is the FDA that should be on trial. He says your own stem cells are not drugs. He says "our cells are safer than any drug on the planet." He vows to fight the FDA suit to the end.
“This is the first case that we bring against the marketer of stem cell therapy,” said Annette Soberats, lawyer for the Federal Trade Commission.
Ms. Soberats says the FTC is also cracking down on shady stem cell clinics.
In California, the FTC charged Dr. Bryn Henderson seen on his Twitter page, with deceptively advertising that “amniotic stem cell therapy” can treat serious diseases, including Parkinson’s, autism, cerebral palsy, and multiple sclerosis.
“They sold them false hope that their stem cell therapy could cure and treat the diseases and then dangerously encourage them to forego other conventional medical treatments,” said Ms. Soberats.
Now, Doris Tyler sees only with her hands. And, the worst part of her loss.
“Most of all is that I can't see my children and grandchildren,” she said.
Doris and her husband Don sued Dr. Walraven, Dr. Halpern, Dr. Berman and his partner in California, blaming them and the stem cell treatment for her blindness.
Dr. Walraven's staff said she had no comment. In her answer to the law suit, she said she didn't know why Doris went blind and denied any negligence.
On the phone, Dr. Mark Berman told me he also doesn't know the cause of her blindness, and claims his network has done successful eye treatments in the past. He said blindness is a known risk from eye injections.
Dr. Halpern filed a motion to dismiss much of the lawsuit.
Doris Tyler hopes her lawsuit will send a message to others who may venture into the world of stem cell promises.
“This seemed to be the only way we could get the word out to the general population that if somebody heard about the city that they would think twice before going through a treatment like this,” said Ms. Tyler.