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Just how effective has the U.S. government been in wringing settlements from pharmaceutical companies in False Claims Act cases over off-label marketing? So effective that when the Department of Justice on Wednesday announced civil and criminal settlements totaling $203.5 million with Elan Corporation for its mislabeling and improper marketing of the epilepsy drug Zonegran, we barely noticed. After similar qui tam settlements in just the last eight months with AstraZeneca for $520 million, Allergan for $600 million, and Novartis for $422 million, what’s another $200 million here or there? Of course, for Elan and its lawyers at Ropes & Gray and Morgan, Lewis & Bockius, the settlements are nothing to sneeze at. Elan’s U.S. subsidiary, Elan Pharmacueticals, pled guilty to a misdemeanor misbranding charge and agreed to pay a criminal fine of $97 million and to forfeit $3.6 million for promoting Zonegran to treat a host of disorders in children and adults for which the drug never received approval from the U.S. Food and Drug Administration. Elan will also pay $102.9 million to end a Zonegan off-label marketing qui tam suit that’s been pending in Boston federal district court since 2004. A Japanese drug distributor called Eisai Inc., which purchased the drug from Elan in 2004, will separately pay $11 million in the qui tam case. (Elan’s criminal information and plea agreement are here and here; the civil settlement agreements with Elan and Eisai are here and here.) The whistleblower in the FCA suit, a Massachusetts doctor named Lee Chartock, will receive $11 million. Chartock’s Boston lawyers, Robert Thomas Jr. of Thomas & Associates and Susan Durrell of the Durrell Law Office, noted in a statement that they also represented one of the whistleblowers in Pfizer’s record-shattering $2.3 billion off-label marketing settlement last year. We tried to reach Ropes & Gray’s Joshua Levy and John Dodds of Morgan Lewis, who represented Elan in both the civil and criminal settlements, but neither returned our calls.

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