Office of the Attorney General
Attorney General Conway Files Medicaid Fraud Suit against Elizabethtown Doctor for Use of Non-FDA Approved Birth Control Device
Attorney General Jack Conway announced today that his Medicaid Fraud and Abuse Control Division has filed a civil lawsuit against Elizabethtown osteopath Dr. Canh Jeff Vo for filing false claims with the Kentucky Medicaid program. The lawsuit alleges that Dr. Vo inserted foreign Mirena® intrauterine devices (IUDs) that had not been approved by the U.S. Food and Drug Administration into Kentucky Medicaid recipients. Dr. Vo purchased the non-FDA approved IUDs over the Internet and illegally imported them into the United States. The lawsuit further alleges that Dr. Vo did not inform his patients that they were receiving non-FDA approved IUDs.
"The allegations we have outlined in our lawsuit are extremely troubling," General Conway said. "We take very seriously our obligation to ensure the safety of patients in Kentucky and to hold accountable businesses that put profits ahead of patient care. We will seek to recover damages, restitution and civil penalties on behalf of the Kentucky Medicaid program."
Unless a prescription drug has been approved for safety and effectiveness by the FDA, it cannot legally be purchased, possessed, delivered, or sold in the United States. And, a prescription drug that has not been approved by the FDA does not qualify as a "covered outpatient drug" under the Medicaid program and is not eligible for Medicaid reimbursement. Because the IUDs inserted into Kentucky Medicaid recipients had not been approved by the FDA, they were ineligible for Medicaid reimbursement and the claims submitted to Kentucky Medicaid were false.
The FDA also approves the product descriptions, instructions for use, warnings, hazards, contraindications, side effects, precautions and other language that must appear on the labels of all prescription drugs sold in the U.S. The most significant of these requirements is that all labels must contain adequate directions for use in the English language so that a layperson can use the drug safely and for the purposes for which it is intended. The package labeling and instructions for use of many of the IUDs inserted into Kentucky Medicaid recipients by Dr. Vo were in Turkish.
The Mirena® IUDs are marketed in the U.S. by Bayer HealthCare Pharmaceuticals, Inc. In 2008, Bayer, the FDA and the American Congress of Obstetricians and Gynecologists each sent letters or notices to healthcare professionals warning them that Mirenas® purchased online from foreign pharmacies were not FDA approved, may have passed through numerous countries before arriving in the U.S. and posed serious health risks.
On March 21, 2013, David J. Hale, the United States Attorney for the Western District of Kentucky, announced that a federal grand jury had indicted Dr. Vo on 13 counts of health care fraud, mail fraud, misbranding and smuggling. The indictment resulted from a joint investigation by General Conway's Medicaid Fraud and Abuse Control Division and the FDA. Dr. Vo's trial in federal court is currently set for May 22, 2013.
Since Attorney General Conway took office in January 2008, his Office of Medicaid Fraud and Abuse Control has recovered or been awarded nearly $300 million dollars for the state and federal Medicaid programs. These cases range from lawsuits and settlements against pharmaceutical companies to cases against individual providers.
In 2012, General Conway's Medicaid Fraud Unit was named one of the most aggressive in the country by the nonprofit watchdog group Public Citizen.
The Attorney General's Tip Line for reporting allegations of Medicaid fraud is 1-877-228-7384.