All drug makers want consumers to believe that their product will be a miracle solution. While many prescription medications can have a palpable impact on the lives of patients, such benefits can only be accrued when the medication is being used for the right condition. However, pharmaceutical companies are held accountable for the efficacy of their drugs and their advertising claims marketing practices.
Recently, the drug maker, UCB has agreed to settle a qui tam lawsuit regarding the epilepsy drug Keppra, for $34.4 million. The North American Division of the Belgium pharmaceutical giant UCB admitted no wrong doing to the allegations, that Keppra, was marketed to treat other non-FDA approved conditions, such as headaches, migraines, and other pain based conditions.
A relator (whistleblower) brought the qui tam complaint against UCB over marketing and advertising practices. The Department of Justice and many AG's from around the country joined in the UCB qui tam complaint regarding the Keppra. The success in the qui tam case is a true testament of how things can work well, when the various federal and state agencies synchronize their efforts. As part of the UCB resolution, the whistleblowers will receive payments totaling more than $2.8 million from the federal share of the civil recovery.
In 2010, UCB made $3.2 Billion in Revenue, therefore, it is easy to see why after preliminary court proceedings, they agreed to settle the False Claims Act violations for a reported $34.4 million dollars. The head of the North American Operations for UCB, Greg Duncan, stated the following:
We are pleased to have resolved this matter and look forward to continuing to work with the many organizations with whom we partner to advance our mission of transforming the lives of people living with severe diseases."
This qui tam settlement includes reimbursements, payments to Medicare, Medicaid, and other government agencies and programs. A large portion of the False Claims Act settlement will be used to compensate plaintiffs in civil cases against UCB.
Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. stated the following:
“Patients have a right to know that the drugs they are prescribed have been approved by the FDA as safe and effective for a particular use. Off-label promotion of pharmaceuticals undermines the FDA’s important role in protecting the public and is a drain on taxpayer dollars.”
In the False Claims Act settlement, UCB also agreed to participate in a corporate integrity agreement, with a five year time line during which the company will cooperate closely with federal investigators to ensure no further lapses in false advertising.
The settlement is another step toward monitoring the booming pharmaceutical industry. Consumers should take note of the settlement as a reminder to be aware of all prescriptions.
If a whistleblower has knowledge of a company's fraudulent activities regarding the defrauding the government, they should report the fraud immediately. Seeking the assistance of a qualified and experienced qui tam attorney is essential in protecting the rights of the relator. This serves to help protect the relator's reward which can be anywhere from 15% to 30%, depending upon whether the government intervenes in the qui tam complaint.
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UCB Pays $34M To Resolve Off-Label Charges - Pharmalot