In what a government press release called the largest settlement in the history of the Northern District of Georgia, pharmaceutical manufacturer Allergan Inc. has agreed to plead guilty and pay $600 million to resolve its criminal and civil liability arising from the company’s unlawful promotion of its biological product, Botox, for uses not approved as safe and effective by the Food and Drug Administration.

The resolution, announced by Atlanta U.S. Attorney Sally Quillian Yates, includes a criminal fine and forfeiture totaling $375 million and a civil settlement with the federal government and the states of $225 million.

“This global resolution marks the end of an investigation that exemplifies what can be accomplished when there is cooperation between law enforcement agencies sharing information and working together,” said Yates in the press release.

“Allergan’s unlawful marketing activities first came to light when two whistleblowers, a doctor who was an Allergan consultant and a Botox® sales representative, filed a False Claims Act complaint against Allergan here in Atlanta,” Yates said. “Our investigation continued to expand after two more whistleblower complaints were filed against Allergan in the District of Massachusetts and the District of Maryland and were transferred to Atlanta where our investigation was underway. The second complaint was filed by two former Allergan employees in the Botox® reimbursement division, and the third by an Allergan sales representative.

Douglas S. Ingram, Allergan’s executive vice president, said in a company press release: “This settlement is in the best interest of our stockholders as it resolves all matters at issue in the investigation, avoids substantial costs of litigation, as well as the substantial risks to Allergan associated with Government enforcement action in these matters, and permits us to focus our time and resources on productively developing new treatments for patients and the medical community.”

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Contributor: Jonathan Ringel in Verdicts & Settlements | subscribe to rss |   share