DOJ joins whistleblower suit against Healthpoint over DESI drug

by Ben Vernia | April 1st, 2011

On April 1, the Department of Justice announced that it was intervening in a qui tam filed in Boston against Ft. Worth-based Healthpoint, Ltd., alleging that the company submitted false statements concerning Xenaderm, a skin medication. According to DOJ’s press release:

The United States has filed a complaint against Healthpoint Ltd., alleging civil False Claims Act violations arising from the company’s sale of an unapproved prescription drug that was ineligible for payment under Medicaid and Medicare, the Justice Department announced today. In the complaint, filed in the District of Massachusetts, the government alleges that the Ft. Worth, Texas-based subsidiary of DFB Pharmaceuticals Inc., submitted false statements concerning the regulatory status of Xenaderm to the United States, thereby causing false or fraudulent prescription claims for the unapproved drug to be submitted to Medicaid and Medicare.

Xenaderm, a skin ointment primarily used to treat bed and pressure sores, otherwise known as “decubitus ulcers,” was launched by Healthpoint in 2002 without any approval by the Food and Drug Administration (FDA). Xenaderm contains trypsin as an active ingredient, which is intended to function in the unapproved drug as a debriding agent, i.e., for the removal of dead tissue around a wound. In the 1970s, however, the FDA determined on at least two separate occasions that trypsin was ineffective as a debriding agent and rescinded the market approval for products containing trypsin as a debriding agent. As a result of these determinations, Xenaderm, which came onto the market much later, was ineligible for reimbursement under Medicaid and Medicare.

The government’s complaint alleges that Healthpoint knew Xenaderm was unapproved, and knew of or recklessly disregarded the FDA notices concerning trypsin’s lack of effectiveness as a debriding agent. According to the complaint, Healthpoint nonetheless falsely represented to the United States that the drug was eligible for Medicaid and Medicare reimbursement. As a result of Healthpoint’s false statements, the United States alleges that Healthpoint caused Medicaid and Medicare to pay tens of millions of dollars for an unapproved drug that was ineligible for reimbursement.

Disclosure: I represent a witness in this case.

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