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Pharmaceutical giant Abbott Laboratories has agreed to pay the government a total of $1.6 billion to settle claims that it illegally promoted off-label uses of its drug, Depakote. As part of the Abbott settlement, the company will pay a $700 million criminal fine and will plead guilty to one misdemeanor, The Washington Post reports.
The agreement marks the end of a four-year investigation into Abbott's marketing practices. Whistleblowers accused the company of marketing Depakote to doctors for schizophrenia, autism and dementia even though it is only approved to treat epilepsy, migraines and bipolar disorder.
Though doctors can prescribe medication for unapproved uses, such uses cannot be marketed or promoted by pharmaceutical companies. Abbott is said to have engaged in this practice on an extreme level.
The most egregious of Abbott's actions involved elderly patients, according to associate attorney general Tony West. The company admitted that it trained salespersons to market Depakote to nursing homes as a way to subdue elderly patients suffering from dementia. They also provided doctors with illegal kickbacks, notes the Los Angeles Times.
Abbott's sales force continued to engage in this behavior even after its own clinical trials showed that such patients often suffer from drowsiness, dehydration and anorexia, the Post reports.
However, these patients and their families will not be taking part in the Abbott settlement. Instead, the monies will be distributed amongst the states that filed Medicare and Medicaid fraud claims. Causing doctors to prescribe and then bill the government for unnecessary, and perhaps unsafe, medication is technically fraud.