A recent federal case represents the latest legal action against a physician for involvement in importing, purchasing, administering and billing of foreign pharmaceuticals and medical devices not approved by the U.S. Food and Drug Administration (FDA).
Julie Reed, ISMA general counsel, warned, “Non-FDA approved foreign medical devices and medications are illegal and could subject you to severe legal, financial and licensing sanctions. Purchasing these products also poses a significant risk to the health and safety of your patients.”
One example from Kentucky
Canh Jeff Van Vo, D.O., owner, supervising physician and president of Bluegrass Women’s Healthcare in Elizabethtown, Ky., was recently charged in a 13-count federal indictment for health care fraud, mail fraud, misbranding and smuggling. The indictment alleges Dr. Vo – with intent to defraud or mislead – purchased, imported and administered foreign Mirena intrauterine devices (IUDs), including those from Canada. The IUDs did not have FDA approval. Package labels were in English and lacked mandatory directions.
In addition, Dr. Vo is alleged to have submitted fraudulent claims to the Kentucky Medicaid program and other private insurers as if he had administered FDA-approved Mirena IUDs. If convicted, he faces up to 233 years in prison, three years supervised release and $3,010,000 in fines.
FDA warnings included Indiana
This is not the first such federal case. In late November 2012, the FDA sent cease and desist letters to more than 350 medical practices, including four in Indiana. According to the letters, the FDA received information that the practices acquired medications, including Botox, from Canadian suppliers.
The letters stated non-FDA approved medications from “foreign or unlicensed suppliers may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported, or stored under proper conditions as required by U.S. law, regulations, and standards.”
Two Texas cases
These cases can also have state law implications. The Texas Attorney General brought at least two cases stemming from a medical device wholesaler that purchased various arthritis injections, such as Orthovisc, from a Canadian company. Product labels were in foreign languages and included instructions for non-FDA approved treatments. Also, the wholesaler was not a properly licensed distributor.
The state alleged the physician and his practice violated multiple laws by purchasing unapproved arthritis injections from an unlicensed wholesaler. In addition to being labeled in a foreign language, the products were only for export and distribution in a foreign country. The labels also lacked necessary cautionary statements.
The physician entered into a voluntary agreement with the Texas Attorney General that included an $86,000 penalty.
The ISMA cautions
Like Texas, Indiana has food and drug, and deceptive consumer sales laws. Typically, the safest practice is to purchase products directly from the U.S. manufacturer and its authorized representatives. Wholesalers must be licensed to conduct business in Indiana; check their status here.
“Physicians concerned that they may have improperly acquired or utilized non FDA-approved drugs or devices should contact their private health care attorneys for advice about any duty to report such activities under the fraud and abuse laws,” said Reed.
If you have questions, contact the ISMA Legal Department at (800) 257-4762 or (317) 261-2060.