January 6, 2012 (Bonita Springs, Florida) — Florida cardiologist, Dr Zannos Grekos (Regenocyte Therapeutic, Bonita Springs, FL), stands accused of contributing to a patient's death by administering an unjustified stem-cell therapy. In the latest twist in the case, Florida Department of Health (FDOH) lawyers are questioning whether the patient ever signed off on the novel therapy in the first place.
In a formal complaint filed in August, the FDOH states that Grekos treated a 69-year-old patient who had breast cancer and 0% to 29% bilateral stenosis of the carotid arteries with an "experimental stem-cell procedure" that included injecting autologous bone-marrow aspirate into the patient's cerebral circulation. The patient was discharged without fully waking from sedation, the complaint alleges, and then later fell and hit her head at home. She died in the hospital soon after, and CT scan and MRIs confirmed the presence of a severe brain stem injury and infarct of the cerebellum. The complaint states that the patient's death resulted from the infarcts of her left cerebella and left medulla.
The FDOH alleges "the treatment provided by Dr Grekos to [the patient] was neither authorized nor recognized by the Federal Drug Administration, [and] Dr Grekos's medical records did not contain medical justification for the injection of autologous bone-marrow aspirate into [the patient's] cerebral circulation as a treatment for [her] neuropathy. Dr Grekos's treatment of [the patient's] neuropathy by the injection of autologous bone-marrow aspirate into the cerebellar circulation had no substantiated medical and/or scientific value."
The FDOH is asking the state's board of medicine to either permanently revoke or suspend Grekos's license and administer fines or "any other relief that the board deems appropriate."
In February 2011, the FDOH issued Grekos an emergency restriction order. The order restricts Grekos from "providing any stem-cell treatment, including but not limited to the injection of autologous bone-marrow aspirate." The order does not bar Grekos from seeing patients if he does not provide the restricted treatment.
The case is working its way through an administrative court in Tallahassee, FL. On January 4, Administrative Law Judge Susan Belyeu Kirkland agreed to schedule the final hearing on the case for March 20–23. Grekos's attorney Richard Brooderson had asked the judge to move the hearing back from the original dates of January 18–20 because of issues that arose during discovery that require Grekos's lawyers to hire additional experts to help mount a defense.
As reported by Naples Daily News, one of the important issues that arose in the depositions is that the husband of the deceased patient believes the signature on certain key documents, including the patient informed-consent form, is not the patient's signature. So Brooderson and the FDOH will both likely be hiring handwriting experts to testify [1].
The lawyers for the FDOH and Grekos have not yet responded to heartwire 's request for comments.
In a formal complaint filed in August, the FDOH states that Grekos treated a 69-year-old patient who had breast cancer and 0% to 29% bilateral stenosis of the carotid arteries with an "experimental stem-cell procedure" that included injecting autologous bone-marrow aspirate into the patient's cerebral circulation. The patient was discharged without fully waking from sedation, the complaint alleges, and then later fell and hit her head at home. She died in the hospital soon after, and CT scan and MRIs confirmed the presence of a severe brain stem injury and infarct of the cerebellum. The complaint states that the patient's death resulted from the infarcts of her left cerebella and left medulla.
The FDOH alleges "the treatment provided by Dr Grekos to [the patient] was neither authorized nor recognized by the Federal Drug Administration, [and] Dr Grekos's medical records did not contain medical justification for the injection of autologous bone-marrow aspirate into [the patient's] cerebral circulation as a treatment for [her] neuropathy. Dr Grekos's treatment of [the patient's] neuropathy by the injection of autologous bone-marrow aspirate into the cerebellar circulation had no substantiated medical and/or scientific value."
The FDOH is asking the state's board of medicine to either permanently revoke or suspend Grekos's license and administer fines or "any other relief that the board deems appropriate."
In February 2011, the FDOH issued Grekos an emergency restriction order. The order restricts Grekos from "providing any stem-cell treatment, including but not limited to the injection of autologous bone-marrow aspirate." The order does not bar Grekos from seeing patients if he does not provide the restricted treatment.
The case is working its way through an administrative court in Tallahassee, FL. On January 4, Administrative Law Judge Susan Belyeu Kirkland agreed to schedule the final hearing on the case for March 20–23. Grekos's attorney Richard Brooderson had asked the judge to move the hearing back from the original dates of January 18–20 because of issues that arose during discovery that require Grekos's lawyers to hire additional experts to help mount a defense.
As reported by Naples Daily News, one of the important issues that arose in the depositions is that the husband of the deceased patient believes the signature on certain key documents, including the patient informed-consent form, is not the patient's signature. So Brooderson and the FDOH will both likely be hiring handwriting experts to testify [1].
The lawyers for the FDOH and Grekos have not yet responded to heartwire 's request for comments.
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