Pharmacuetical Company Admits to Promoting Drug for Off-Market Uses in Nursing Homes

A large pharmaceutical company has agreed to pay federal and state governments $1.6 billion in fines for illegally promoting unapproved uses of its drug Depakote, including it's use to sedate elderly patients in nursing homes, officials announced Monday.

Depakote, which the FDA has approved to treat three conditions: epileptic seizures, migraines, and the manic episodes experienced by people with bipolar disorder was being promoted for "off-market" uses by the company. Off-market promotions are illegal and can lead to harm to patients.

As part of the settlement, the company admitted that since 1998 it trained a special sales force to promote the drug to nursing-home employees as a way to control the agitation and aggression that can occur in elderly patients suffering from dementia. However, a clinical trial the next year showed that the drug increased the incidence of drowsiness, dehydration and anorexia in elderly study participants. The company continued promoting the drug in nursing homes through 2006.

The Medicaid Fraud Control Unit of the Virginia attorney general’s office teamed with the U.S. Attorney’s office of Virginia’s Western District to investigate the case. Officials said the four whistleblowers went to Virginia to pursue the case because of the unit’s track record of successful investigations. They will split $84 million of the federal share under the False Claims Act. For more, read the story.

 


Robert W. Carter, Jr. is a Virginia attorney whose law practice is dedicated to protecting the rights of the victims of nursing home and assisted living neglect and abuse in Richmond, Roanoke, Norfolk, Lynchburg, Danville, Charlottesville, and across Virginia.







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