Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies.
(PRWEB) May 17, 2012
The Consumer Justice Foundation, a for-profit corporation whose team of professional consumer advocates provide free online informational resources regarding the potential dangers of using certain prescription medications, hereby reports that Business Week has published an article that states that Abbott Laboratories, the manufacturer of anticonvulsant medication Depakote, has agreed to pay a $1.6 billion settlement to the government to settle all ongoing investigations regarding alleged marketing of Depakote for off-label purposes.
The investigation does not carry with it a legal citation, as this stage exists prior to litigation. However, Abbott Laboratories has stated that the settlement breaks down such that it will pay $800 million to resolve civil allegations split among federal and state governments, $700 million for a criminal penalty. Abbott said it is also paying $100 million to the states to resolve consumer protection matters.
The investigation was ongoing because Depakote was approved for use for treatment of symptoms of conditions that include epilepsy, migraine headaches and the symptoms associated with the manic episodes of bipolar disorder, but Abbott Laboratories allegedly marketed the drug for off-label or unapproved uses such as dementia.
“Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks of Depakote side effects apparent from its own clinical studies,” Acting Associate Attorney General Tony West said in the Justice Department statement. “As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price.”
“Abbott admits that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use,” the Justice Department said in its statement yesterday.
About the Consumer Justice Foundation
The Consumer Justice Foundation, whose Web site is located at http://www.consumerjusticefoundation.com, is a public resource that's been built and maintained by a group of concerned professionals who want to provide general information for consumers regarding the potential dangers involved with the use of Depakote while pregnant. This resource is not to be considered as medical or legal advice, which should only be dispensed by a licensed medical doctor or a Depakote lawyer.