AstraZeneca recently settled federal investigations regarding its marketing practices of Seroquel for $520 million. Although Seroquel had only been approved by the FDA to treat schizophrenia and acute bipolar I disorder, whistleblower James Wetta accused the company of embarking on a national sales program to promote Seroquel for off-label use by the elderly, children and prisoners. According to the complaint, AstraZeneca disseminated false information to child and adolescent psychiatrists, primary care physicians, and elderly patients suffering from age related dementia. Among the off-label marketing tactics alleged by Wetta was sponsorship of “continuing medical education” seminars, which doctors must enroll in to keep their medical license. Continue reading ›
Articles Posted in Pharmaceutical Fraud
Drug Maker Novartis in Trouble Again for Illegal Marketing: This Time on Facebook
The U.S. Food and Drug Administration (FDA) has issued a letter to drug maker Novartis warning it to cease its incomplete and misleading promotion of the leukemia fighting drug Tasigna on Facebook. Novartis had been using Facebook’s “share button” to market the drug on the social website giant. However, in violation of federal laws, the advertisements failed to include the risks associated with taking the drug. Additionally, despite the fact that clinical trials have not shown the drug to be more effective than its competitors, the Facebook advertisement promoted the drug as superior to other products – again in violation of federal law. Continue reading ›
Alpharma Settles False Claims Act Suit for $42.5 million
A multi-state agreement was reached between 49 states, the District of Columbia, and Alpharma Inc. on June 8 to settle allegations of kickbacks and off-label promotion of its drug, Kadian. A whistleblower receiving $5.33 million of the total $42.5 million settlement initially filed the lawsuit in 2006 under the False Claims Act.
Between January 2000 and December 2008, Alpharma allegedly paid kickbacks to doctors to encourage them to prescribe Kadian or both approved and off-label uses. Continue reading ›
Elan Pharmaeuticals Settles Off-Label Charges
Pharmaceutical company Elan Corporation recently announced an agreement with the DOJ to pay $203.5 million to settle Medicaid fraud claims involving its previously divested antiepileptic drug, Zonegran. As a result of the agreement, Elan pled guilty to a misdemeanor violation of the Food Drug and Cosmetics Act (FDCA) and plans to enter into a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. Continue reading ›
DOJ Turns up HEAT on Medicare Fraud: 94 People Charged With Submitting More than $251 Million in False Claims
The Department of Justice (DOJ) announced today that it has charged 94 doctors, healthcare company owners, and executives with submitting more than $251 million in false claims to Medicare. The arrests spread across five different states in areas the federal government has deemed fraud hotspots. It was the largest federal crackdown on Medicare fraud since Medicare Fraud Strike Force activity began.
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Court Allows Derivative Shareholder Suit Against Pfizer to Move Forward
A federal district court judge has denied Pfizer’s motion to dismiss a derivative shareholder suit against the company which alleges that directors and executives at Pfizer are liable for actions that led to a historic $2.3 billion settlement with the U.S. government in 2009. Pfizer entered into this enormous settlement to resolve allegations under the federal False Claims Act and Anti-kickback Statute for alleged “off-label promotion” of various drugs, including Bextra and Celebrex. Continue reading ›
U.S. Requests Authority to Exclude Pharmaceutical Executives from Medicare
The Department of Health and Human Services (HHS) is asking Congress for the power to boot executives convicted of Medicare fraud from federal health programs such as Medicare and Medicaid. These booted executives will struggle to find new employment in the industry, considering the U.S. government is the largest prescription drug customer in the world. Specifically, HHS wants the authority to kick out anyone “who was in a position to have stopped the fraud that led to a criminal conviction or plea.”
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