A foreign pharmaceutical company has recently agreed to pay $203.5 million to resolve criminal and civil product liability complaints that it improperly marketed the antiseizure medicine Zonegran for weight loss and mood stabilization, according to the Ne w York Times. The Justice Department announced additionally that another drug maker agreed to pay $11 million to resolve a civil case for off-label marketing of Zonegran after it bought rights to the drug from the other company in 2004. The cases rose from a 2004 whistle-blower filing by a Massachusetts psychiatrist who said he had been courted by the pharmaceutical company, sent to a conference, and asked to prescribe the drug for weight loss. The company promoted the drug for uses including mood stabilization, bipolar disorder, migraine headaches, weight loss, and seizures in children. According to the Justice Department, the off-label marketing efforts targeted non-epilepsy prescribers and the company paid illegal kickbacks to physicians in an effort to persuade them to prescribe the drug for off-label uses. This settlement is part of the government’s emphasis on combating health care fraud. One of the most powerful tools at the government’s disposal is the False Claims Act, which the Justice Department has used to recover more than $5 billion since January 2009 in cases involving fraud against federal health care programs.
Experts have also reported that the False Claims Act can root out nursing home abuse, fraud, and neglect. By law, nursing homes cannot receive funding from public health care programs like Medicare or Medicaid unless the facility cares for its residents in a manner respecting the quality of life of each resident. A key provision in the False Claims Act allows persons with knowledge of fraudulent claims being submitted to federal programs to bring a lawsuit against the facility on behalf of the government. Another provision allows whistleblowers to earn between 15 and 30 percent of money recovered by defendants.
More information about the large product liability settlement is available at The New York Times.
To read more about the False Claims Act used against nursing home abuse, read our former blog post.