Tennessee doctor, wife pay over $1.2 million to settle charges related to sale of unapproved drugs

by bvernia | August 25th, 2017

On June 27, the Department of Justice announced that a Johnson City, Tennessee, physician and his wife had agreed to settle civil False Claims Act charges related to the sale of unapproved, foreign-made drugs for a total of $1.208 million. According to DOJ’s press release:

Dr. Anindya Sen and Patricia Posey Sen will pay $1.208 million to resolve state and federal False Claims Act allegations that their medical practice billed Medicare and Tennessee Medicaid (TennCare) for anticancer and infusion drugs that were produced for sale in foreign countries and not approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States, the Department of Justice announced today. Dr. Sen owns and operates East Tennessee Cancer & Blood Center and East Tennessee Hematology Oncology and Internal Medicine located in Greeneville and Johnson City, Tennessee. Mrs. Sen managed Dr. Sen’s medical practice from 2009 through 2012.

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The United States alleged that the unapproved drugs that the Sens provided to patients and billed to Medicare and TennCare were not reimbursable under those programs. The United States further alleged that the Sens purchased unapproved drugs because they were less expensive than the drugs approved by FDA for marketing in the United States. The Sens thus allegedly profitted by administering the cheaper unapproved drugs.

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The case was apparently the result of a government investigation, and not a whistleblower’s qui tam lawsuit.

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