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Home/Legal & Regulatory and Reimbursement/Misleading Stem Cell Claims Cost NY Clinic $5.1M
Legal & Regulatory and Reimbursement

Misleading Stem Cell Claims Cost NY Clinic $5.1M

December 15, 2021 2 min read Premium comments

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New York Attorney General Letitia James has announced a $5.1 million judgment against New York, New York-based stem cell clinic Park Avenue Stem Cell and Joel B. Singer, M.D., its principal and operator.

In 2019 the People of the State of New York filed a lawsuit against Image Plastic Surgery, LLC doing business as Park Avenue Stem Cell and Dr. Singer. It alleged that Dr. Singer engaged in “fraudulent acts and practices in the marketing of stem cell procedures.”

Among other claims, the complaint alleged that between 2016 and 2018 the Park Avenue Stem Cell website (which is no longer accessible) stated, “Our center focuses on utilizing your own stem cells and targeting them for orthopedic purposes, so that your body can repair itself, without any invasive treatments.”

Additionally, under “Orthopedic Disease” the website purportedly stated, “We have an intensive clinical experience in the investigation of the use of SVF to mitigate inflammation and damage in the joints.” SVF stands for stromal vascular fraction. It was manufactured from patients’ stem cells and put back into the patient.

At the time the complaint was filed, it asserted that the website advertised, “Our Park Avenue Location in NYC focuses on utilizing your own personal cells and targeting them for orthopedic purposes, so that your body can repair itself, without any invasive treatments.”

Patients at the clinic could expect to pay at least $3,995 per stem cell treatment. This was purportedly the minimum amount that many patients would pay out of pocket as multiple treatments were allegedly encouraged.

A total judgment was entered against Dr. Singer in the amount of $5,150,933.94. This amount includes restitution of $3,995 for each of Dr. Singer’s 114 patients who received SVF treatment.

In a press release, James stated, in part, “Misleading New Yorkers who are seeking treatment for serious and potentially life-threatening medical conditions is unlawful and an affront to our societal values.”

James continued, “Consumers place a great deal of trust in health care professionals and should receive accurate information when undergoing medical treatments, but Park Avenue Stem Cell and its managing doctor violated that trust in an effort to line their pockets at the expense of patients’ health.”

React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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