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.
by Nolan and Auerbach on April 22, 2009
The Obama Administration strongly supports enactment of S. 386 (the Fraud Enforcement and Recovery Act of 2009), according to a statement released April 20, 2009, by the Executive Office of the President. The White House’s recent endorsement of this legislation which, among other things, restores the original power of the False Claims Act, comes with broad support from law enforcement and the Department of Justice, according to an April 22 press release by Senator Patrick Leahy (D-Vt.), who introduced the Fraud Enforcement and Recovery Act (with Senators Chuck Grassley (R-Iowa) and Ted Kaufman (D-Del.) on February 5.
To read the press release and the senator’s statement, go to http://leahy.senate.gov/press/200904/042209a.html.
For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.
by Nolan and Auerbach on March 5, 2009
The fate of a bill amending the False Claims Act (FCA) is in Senate hands. The False Claims Clarification Act of 2009, introduced by Sen. Chuck Grassley (R-Iowa) (S. 458), could fuel government’s ability to recover taxpayers’ dollars lost to fraud and abuse by increasing government accountability and extending whistleblower protection. Under the new legislation, the attorney general would be required to submit an annual report to Congress about settlements made under the FCA. This would help determine if the Department of Justice is using the act as it is intended and ensure that qui tam relators are protected from the court’s potential abuse of provisions to seal a case.
To review the legislation, go to http://thomas.loc.gov/cgi-bin/query/z?c111:S.458: Or, for more information about qui tam whistleblower law, contact Nolan and Auerbach, PA.