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SACRAMENTO – California Department of Health Services (CDHS) today announced an investigation by CDHS which has found that some physicians have illegally obtained contraceptive devices whose safety and effectiveness are unknown since they have not been approved by the federal Food and Drug Administration (FDA).
State law requires physicians to provide intrauterine devices (IUDs) that are FDA approved and purchased from a licensed distributor within the United States. To date the investigation has identified eight Southern California physicians have obtained IUDs from unlicensed private parties, internet vendors and in Mexico.
"The physicians under investigation have failed to provide proper evidence that shows they purchased federally approved IUDs from FDA-approved sources," said Dr. Mark Horton, State Public Health Officer. "The fact that these IUDs have not been properly obtained means their safety and effectiveness are unknown. We will sanction those Family PACT and Medi-Cal providers who have violated the law and failed to protect the health of Californians."
The investigation stems from a case in 2005 when CDHS sanctioned a physician for providing IUDs that were obtained from unapproved sources. Subsequently, CDHS investigators initiated a review of the Family PACT and Medi-Cal providers who provide the most IUDs to determine if the practice was isolated. Information obtained in that review led CDHS to launch an investigation that identified seven additional physicians who were engaged in the illegal practice. CDHS is seeking to recover funds paid for providing non-FDA approved IUDs and has referred these cases to the California Medical Board, state Department of Justice and FDA.
In addition, CDHS has directed all eight physicians to notify, via certified mail, all patients who received an IUD from January 1, 2005 to the present. The physicians must also provide CDHS with a copy of each notification sent to Family PACT and Medi-Cal beneficiaries.
Seven physicians have agreed to send letters to their patients which include 813 Family PACT and Medi-Cal beneficiaries. These physicians have offices in Alhambra, Downey, Glendale, Hemet, Los Angeles, Norwalk, Santa Ana and Van Nuys. One of the physicians, Dr. Hezekiah Moore of Long Beach, has not agreed to notify his patients as directed. CDHS is pursuing legal action to suspend Dr. Moore from participating in Family PACT and Medi-Cal. CDHS will send letters to 52 of his patients in those programs.
The letters advise patients that if the IUD has already been removed they do not need to take any action. If the patient still has the IUD, the letter recommends that the patient consult with her physician to consider whether to leave the IUD in place, have it replaced with an FDA-approved IUD or have it removed and switch to another method of birth control. For patients still eligible for Family PACT or Medi-Cal services, there is no cost for these services.
CDHS is conducting a wider review of providers across the state enrolled in Family PACT and Medi-Cal to identify other physicians who may be engaged in this practice. Results of this review will be shared with the FDA.
Family PACT and Medi-Cal beneficiaries can obtain more information, including where they can find another Family PACT or Medi-Cal doctor or clinic for services, by calling
1-866-781-0330.
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