Cases
Blank Rome Represents Whistleblower in Second Largest Single-Drug Settlement in Healthcare History
May 2012The Blank Rome team, led by Scott Simmer and Tom Poulin, represented a whistleblower in a $1.5 billion settlement with Abbott Laboratories, marking the second largest single-drug settlement in the health care industry. The Blank Rome suit alleges that Abbott illegally off-label promoted the drug Depakote® for the treatment of agitation and aggression associated with dementia and for the treatment of schizophrenia and other conditions, and paid kickbacks to induce the prescribing of Depakote to nursing home patients. There was no substantial clinical evidence supporting Abbott’s claims of efficacy for these conditions, nor had the FDA approved the use of Depakote for these conditions—such unapproved uses are also known as “off-label” because they are not included in the drug’s FDA-approved product label. Abbott agreed to plead guilty to one criminal count of misbranding Depakote, pay $800 million in a civil settlement, and a $700 million criminal penalty. Abbott also agreed to enter into a Corporate Integrity Agreement for the next five years and put a rigorous compliance program in place.
The Blank Rome team drafted a thorough and compelling complaint that was instrumental in securing this favorable verdict on behalf of our client.