New Hope Fertility Lawsuit: FDA Letters and Chapter 11 Bankruptcy

New Hope Fertility Center, the Manhattan IVF clinic founded by Dr. John Zhang, has been named in a patient malpractice and consumer-protection lawsuit, hit with repeated FDA enforcement over donor screening and an unauthorized genetic procedure, and taken through a Chapter 11 bankruptcy. The clinic is still open and now operates from 784 Park Avenue in Manhattan.¹

The Fleischer Patient Lawsuit

Georgette Fleischer sued Dr. Zhang, New Hope Fertility Center, and several associated doctors and entities in New York Supreme Court (index number 100163/22) after IVF treatment failed to produce a second child genetically related to her first. She brought a dozen causes of action, including medical malpractice, negligence, fraud, intentional infliction of emotional distress, battery, breach of contract, unjust enrichment, and a consumer-protection claim under New York General Business Law § 349. The complaint alleged mishandling of her eggs, sperm, and embryos, and false advertising of the clinic’s success rates.²

The lower court dismissed most of her claims. On June 13, 2024, the Appellate Division, First Department, unanimously modified that ruling. It reinstated the § 349 deceptive-advertising claim, finding Fleischer had sufficiently alleged that the clinic materially misrepresented its IVF success rates. Everything else stayed dismissed.³

The appellate court drew a sharp line between malpractice and other civil theories. Allegations about failures to vitrify, fertilize, and screen reproductive material sounded in medical malpractice because they required professional judgment, so repackaging them as fraud or ordinary negligence did not work. The intentional infliction claim was time-barred, with the court finding it accrued on October 18, 2020, when the defendants published a research paper that allegedly revealed experimental conduct on Fleischer’s reproductive material. The court called the experimentation allegations “completely speculative.” Fleischer conceded the battery claim was time-barred. The breach of contract claim failed because the defendants never promised a specific outcome, and the unjust enrichment claim failed because she received the services she paid for, even though they did not succeed.³

FDA Enforcement Over Donor Screening

After a November 2021 inspection, the FDA issued a warning letter on June 24, 2022, citing what the agency called “significant deviations” from federal regulations governing human cells, tissues, and cellular and tissue-based products. The letter identified failures in how the clinic screened and documented egg and sperm donors.⁴

Donors were cleared as eligible despite reporting Zika virus risk factors, with the clinic using an incomplete list of affected countries.
Eligibility was determined before required communicable disease test results came back.
At least one donor who tested reactive for antibodies to hepatitis B core antigen was not classified as ineligible.
At least 25 donor records were missing responses to mandatory medical-history questions.
Several donors had no documentation showing how or when eligibility was assessed.

The FDA ordered the clinic to quarantine reproductive materials from donors whose eligibility had not been properly established, and found the clinic’s December 2021 corrective labeling procedure inadequate. The agency also noted that many of the same problems had been flagged in an August–September 2014 inspection, which produced a November 2014 warning letter and a March 2015 regulatory meeting. The corrective measures the clinic committed to then, including staff retraining and new donor screening checklists, were “either not implemented or were not effective to prevent the recurrence” of the violations.⁴

A February 2024 FDA inspection cited three additional regulatory violations covering environmental controls, donor eligibility documentation, and labeling.⁵

The Three-Parent IVF Enforcement Letter

In April 2016, a team led by Dr. Zhang used a “spindle nuclear transfer” procedure — a form of mitochondrial replacement therapy sometimes called “three-parent IVF” — to help a Jordanian couple avoid passing on Leigh syndrome, a fatal neurological disorder. A baby boy was born on April 6, 2016. The procedure took place in Mexico, but the embryo was created in the United States.⁶

The FDA had never authorized the procedure in the United States, and Congress had blocked the agency from accepting applications for clinical research involving embryos with heritable genetic modifications. After the birth became public, Zhang asked the FDA for a meeting to discuss a formal clinical investigation, and the agency declined. In August 2017, the FDA sent Zhang a formal letter ordering him to stop marketing the technique. The agency noted that Zhang had previously pledged not to use the technology in the U.S. without an approved investigational application, yet continued to promote it through his startup Darwin Life, which marketed the procedure to older women seeking pregnancy.⁷ The procedure remains unauthorized in the United States.⁸

The Chapter 11 Bankruptcy

Zhang Medical P.C., the professional corporation operating New Hope Fertility Center, filed for Chapter 11 bankruptcy on April 30, 2023, in the U.S. Bankruptcy Court for the Southern District of New York. It initially sought protection under Subchapter V, a streamlined track for small businesses.⁹

The trouble started with the lease at 4 Columbus Circle, where the clinic had operated since 2001. A 2018 amendment doubled the clinic’s space. When the COVID-19 pandemic hit, the clinic could not find subtenants for the added floors and fell behind on rent to its landlord, GLL BVK Columbus Circle LLC. Two months after filing, the clinic moved to reject the lease, and the court granted that motion the following month. The landlord filed a proof of claim totaling roughly $7 million for unpaid rent, a rent credit clawback, replenishment of the security deposit, a mechanic’s lien claim, and other charges.⁹

In August 2023, the landlord objected to the clinic’s Subchapter V designation, arguing its debts exceeded the $7.5 million eligibility cap. Judge Philip Bentley sustained the objection, finding noncontingent, liquidated debts of at least $9,129,684. The court rejected the landlord’s broader theory, however, holding that future obligations under executory contracts and unexpired leases should “rarely, if ever” count toward the Subchapter V debt calculation. The modified ruling was signed on November 30, 2023.⁹¹⁰

The case then continued as a standard Chapter 11. The court confirmed the reorganization plan on April 28, 2025, and the case remained active in post-confirmation status as of April 2026, with the clinic filing required quarterly reports.¹¹

Is the Clinic Still Operating?

Yes. New Hope Fertility Center relocated from Columbus Circle to 784 Park Avenue in Manhattan and continues to operate under Dr. Zhang’s leadership, offering IVF, IUI, egg freezing, and other fertility services as of mid-2026.¹

1
New Hope Fertility Center. New Hope Fertility Center
2
Findlaw. Fleischer v Zhang
3
NY Courts. Fleischer v Zhang, Case No. 2023-05453
4
U.S. Food and Drug Administration. Warning Letter to Zhang Medical P.C. dba New Hope Fertility Center
5
Global Key Solutions. FDA Inspections – Zhang Medical PC dba New Hope Fertility Center
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CNN. FDA Chastises Doctor for Promoting Three-Parent Fertility
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The Scientist. FDA Chastises Doctor for Promoting Three-Parent IVF
8
Science. Unanswered Questions Surround Baby Born to Three Parents
9
Findlaw. In Re Zhang Medical P.C.
10
NYSB U.S. Courts. In Re 23-10678-PB Zhang Medical P.C.
11
PACER Monitor. Zhang Medical PC Bankruptcy Case