Dickson, Tennessee Medical Practice To Pay More Than Half A Million Dollars To Settle False Claims Act Allegations
Dickson Medical Associates, P.C. (“DMA”) of Dickson, Tennessee has agreed to pay civil damages of over $500,000 to settle allegations that it violated the False Claims Act, announced David Rivera, United States Attorney for the Middle District of Tennessee. The alleged false claims involved the importation and distribution of foreign, non-FDA approved prescription drugs prohibited under the Food, Drug, and Cosmetic Act.
Specifically, the settlement resolves allegations by the United States that a doctor, through DMA and as one of its physicians and shareholders, obtained Aclasta®, a non-FDA approved version of the drug Reclast®, from foreign distributors at various times from 2008 through 2012. The doctor prescribed these drugs to patients and then, through DMA, billed for the foreign drugs as FDA-approved Reclast®, despite the fact that the foreign drugs were not intended for distribution in the United States and in some instances, the drug labels appeared in foreign languages. The drug is predominantly used to treat osteoporosis and bone damage.
“The Food, Drug and Cosmetic Act and its enacting regulations exist to ensure the safety and efficacy of prescription drugs sold within the United States,” said U.S. Attorney David Rivera. “The resolution set forth in this settlement agreement should send a clear message that this Office will diligently pursue any violations of those laws.”
This matter was investigated by the U.S. Food and Drug Administration- Office of Inspector General, the U.S. Department of Health and Human Services- Office of Inspector General, the Tennessee Bureau of Investigation, and the United States Attorney’s Office for the Middle District of Tennessee. The United States was represented by Assistant U.S. Attorney Christopher C. Sabis.
This settlement agreement is neither an admission of liability by DMA nor a concession by the United States or the State of Tennessee that the claims are not well founded.