GE Healthcare, a major, international provider of pharmaceuticals and technology, agreed to pay $30 million to the U.S. to settle allegations that it improperly billed Medicare for its radiopharmaceutical drug Myoview.   The settlement arose from a qui tam suit filed under the False Claims Act by James Wagel, a salesman for competing drug Cardiolite, in 2006. According to Wagel, GE Healthcare knowingly provided false information to the federal Medicare program from 2000 to 2003 regarding the reimbursement of Myoview, a diagnostic drug used for cardiology patients.  More specifically, GE Healthcare improperly marketed the drug to physicians as one that could be diluted to maximize the number of doses per vial, while still receiving an inflated reimbursement from Medicare for each vial. As part of the settlement, Wagel will receive $5.1 million.

For more information see: http://www.freep.com/article/20111229/NEWS06/112290468/Pharmaceutical-firm-to-pay-36-30M-settlement-in-false-claims-suit?odyssey=mod|newswell|text|FRONTPAGE|shttp://

Diakon Lutheran Social Ministries, a charitable organization operating as Diakon Hospice St. John (Diakon), agreed to pay the U.S. $10.56 million to settle allegations that it submitted claims for Medicare reimbursement for ineligible hospice patients from October 1, 2004 to October 1, 2010.   Diakon, which is part of the Evangelical Lutheran Church of America, offers hospice services throughout Pennsylvania, Maryland, and Delaware.  Diakon voluntarily disclosed to the U.S. Government that it received Medicare reimbursement for hospice patients who were ineligible for  such reimbursement under Medicare regulations.  By voluntarily disclosing the improper reimbursement, Diakon avoided a potential False Claims Act suit which would provide treble damages and civil penalties of up to $11,000 per claim.

For more information see: http://www.justice.gov/usao/pam/news/2011/Diakon_12_01_2011.htm

Merck has agreed to plead guilty to a misdemeanor criminal charge and pay $950 million to the federal and state governments to resolve allegations that it illegally marketed its painkiller drug Vioxx for off-label use and made false statements about the drug’s cardiovascular risks. Merck not only withheld data showing that Vioxx increased patient’s risks of heart attack and stroke, but also illegally marketed the drug for the treatment of rheumatoid arthritis before receiving FDA approval.  Of its $950 million settlement, Merck will pay $321.6 million to resolve a criminal fine, and $628.3 million to resolve civil allegations brought by the federal and state governments.  Of the civil settlement, the federal government will receive $426.4 million and forty-three state governments will share $202 million.  Merck had already paid $4.85 billion to settle thousands of patient lawsuits related to the heart attacks and strokes allegedly caused by the drug, as well as $1.9 billion in legal costs. 

For more information see: http://www.justice.gov/opa/pr/2011/November/11-civ-1524.html

GlaxoSmithKline, one of the world’s largest drug manufacturers, settled a number of claims resulting from government investigations including one tied to the sale of diabetes drug, Avandia, which has been associated with increased heart risks, and one related to off-label marketing of other drug products. GlaxoSmithKline contends that as a result of claims such as these, it has revamped its compliance and marketing practices to avoid risks of illegal and improper marketing.

For more information see: http://www.foxbusiness.com/markets/2011/11/03/glaxosmithkline-settles-us-drug-rows-for-3-billion/#ixzz1ceogx5jt

DFine, a California provider of vertebral augmentation devices, agreed to resolve Justice Department allegations of false claims for $2.9 million.  The government charged DFine with using customer surveys as vehicles to pay participating physicians kickbacks to induce them to use DFine devices.  The government alleged that DFine paid $500 to a physician who provided product information, which was coupled with the sale of a new device to the physician’s patient.  All of the payments were alleged to be in violation of the federal Anti-kickback statute.  The government claims were based on the complaint of a whistleblower who received $250,000 for reporting the alleged conduct.  As part of the settlement, DFine will enter into a corporate integrity agreement with the government to avoid similar conduct in the future. 

For more information see:  

http://7thspace.com/headlines/398026/usdoj_california_based_dfine_inc_to_pay_us_more_than_
23_million_to_settle_claims_that_company_paid_kickbacks_to_physicians.html