The DOJ reported today that SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, pleaded guilty to False Claims Act charges and agreed to a fine totaling $750 million. The total includes a criminal fine of $150 million and a civil False Claims Act fine of $600 million.
This case represents the first time the False Claims Act has been used to combat violations of FDA manufacturing standards. Continue reading ›
U.S. Senator Charles Grassley (R-Iowa), a long-time proponent of the False Claims Act and an anti-fraud advocate, has recently criticized reports of high-volume prescribers. In particular, Grassley addresses those prescribing extremely large quantities of mental health drugs. Recently, many pharmaceutical companies have agreed to large settlements involving the off-label promotion of these drugs, many of which are the must lucrative of the companies’ offerings.
In his report to Congress, Grassley identified a Miami doctor who allegedly wrote approximately 97,000 prescriptions in 18 months for mental health drugs- averaging about 177 prescriptions per day. He also cited a Texas doctor who wrote 14,170 prescriptions for Xanax in 2009. Continue reading ›
In wake of many of the recent, massive pharmaceutical fraud settlements, government officials are exploring the possibility of holding pharmaceutical executives criminally liable for their company’s off-label promotion efforts. Despite the occurrence of massive settlements, many commentators and legal analysts believe they are simply the cost of doing business within the pharmaceutical industry. For this reason, further incentives are being developed to further deter fraud within pharmaceuticals. Continue reading ›
Delaware recently withdrew its intervention in a False Claims Act case filed against J-M Manufacturing. Whistleblower John Hendrix, a former engineer for J-M Manufacturing in New Jersey, filed the suit against the manufacturer in 2006. Virginia, Tennessee, and Nevada remain in the suit, as well as 47 municipalities and water districts. In his complaint, Hendrix asserted that he was fired in retaliation less than two weeks after writing a memo alerting the company to substandard pipe strength. Continue reading ›
On November 17, 2008, two whistleblowers filed a qui tam action against Medtronic, a medical device manufacturer, alleging off-label promotion of Cardioplate, a heart device. The U.S. District Court in Houston recently granted Medtronic a motion to dismiss the case. The device is FDA approved for ablating (removing) tissue to control bleeding during general surgery and to coagulate cardiac tissue during general surgery. According to the dismissed complaint, Medtronic promoted Cardioplate for the treatment of atrial fibrillation (fast and irregular heartbeat), a use not approved by the FDA as safe and effective. Continue reading ›
A securities fraud class-action lawsuit has been filed against Green Mountain Coffee Roasters Inc. in U.S. District Court in Vermont. The suit was originally brought by a whistleblower alleging accounting irregularities. Under the Dodd-Frank Wall Street Reform and Consumer Protection Act, the SEC may award between 10 percent and 30 percent of more than $1 million to any whistleblower providing “original information” leading to a successful SEC enforcement. Continue reading ›
On September 28, Senator Majority Whip Dick Durbin (D-IL) addressed Congress in an attempt to highlight the fraud-ridden for-profit education industry. Durbin states that for-profit colleges receive the largest share of federal funding, yet are often under-performing. The University of Phoenix, DeVry University, and Kaplan University rank as the top three college recipients of federal funding — and all three have faced False Claims Act or class action lawsuits alleging questionable loan practices, false and misleading statements and advertising, and falsified documents to obtain accreditation. Kaplan University currently faces a False Claims Act suit already slated for trial. Continue reading ›
The federal government has elected to intervene in a False Claims Act against the Mayo Clinic. Over the course of ten years, Mayo allegedly filed false claims to Medicare and Medicaid for surgical pathology services that were never performed. The Clinic is also accused of failing to comply with federal regulations requiring that medical laboratories retain pathology slides for ten years. The Department of Justice, however, is only joining for the former claim, involving tests never performed.
New whistleblower provisions in the recently passed Dodd-Frank Act enable whistleblowers to receive rewards for reporting violations of the Foreign Corrupt Practices Act (FCPA). The FCPA prohibits bribery of foreign government officials in international business transactions and false entries in books and records of those companies within the statute. Whistleblowers assisting in a recovery receive a monetary award between 10-30%. Continue reading ›
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 ›
Whistleblower Attorneys Blog
