False Claims Act/Qui Tam

This blog is about qui tam, a  lawsuit brought under the False Claims Act by a private plaintiff on behalf of the Federal or State Government (rather than by the Government itself). The False Claims Act was originally enacted by Congress in 1863, as a response to widespread abuses by government contractors against the Union Army during the Civil War. The qui tam provisions are now used widely and this blog is intended to keep readers up to date with all qui tam related news and to provide commentary when warranted.  This blog also contains an array of laws and regulations concerning qui tam set out in an easy to read format.

Posts tagged as:

unapproved drug

Eon Labs Pays U.S. $3.5 Million to Settle Medicaid False Claims Allegations in qui tam case brought by Nolan and Auerbach, P.A. Client

by Nolan and Auerbach on February 22, 2010

Eon Labs Inc. has agreed to pay the United States $3.5 million to resolve False Claims Act allegations relating to the company’s drug Nitroglycerin Sustained Release (SR) capsules, the United States Department of Justice (DOJ) announced Feb. 22, 2010. Eon Labs is a subsidiary of Sandoz Inc., which is in turn a subsidiary of Novartis AG.

In April 1999, the Food & Drug Administration (FDA) determined that the unapproved drug Nitroglycerin SR lacked substantial evidence of effectiveness and published a notice proposing to withdraw approval of the product.  The qui tam lawsuit alleged that, after the FDA notice, Nitroglycerin SR no longer was legally eligible for reimbursement by government health care programs such as Medicaid.

The lawsuit alleged that  Eon submitted false quarterly reports to the government that misrepresented Nitroglycerin SR’s regulatory status as a Covered Outpatient Drug under the Medicaid program.

The settlement resolves allegations against Eon in a multi-defendant whistleblower action, which remains sealed in part.

For the full release, go to: http://www.justice.gov/opa/pr/2010/February/10-civ-171.html.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA. at http://www.whistleblowerfirm.com.

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Medicis Pharmaceutical Pays $9.8 Million to Settle False Claims Accusations

by Nolan and Auerbach on May 17, 2007

Medicis Pharmaceutical, located in Scottsdale, Arizona, is paying $9.8 million to settle False Claims Act allegations.  This case was brought by four former Medicis sales representatives. The allegations centered around Loprox, a topical skin preparation.  Loprox, while approved by the FDA as a fungicide for patients over 10 years of age, was off-label marketed for the treatment of diaper rash.  This marketing or promoting for unapproved uses by Medicis Pharmaceutical is prohibited.

To read more about this case, click here or  to read more on filing qui tam actions go to Nolan & Auerbach.

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