Johnson & Johnson Subsidiaries to Pay $81M to Resolve Off-Label Marketing Claims
The law firm of Frank, Haron, Weiner and Navarro, in collaboration with the United States Attorney’s Office for the District of Massachusetts and the firm of Phillips & Cohen LLP, has reached a settlement with two Johnson & Johnson subsidiaries to pay more than $81 million to resolve criminal and civil liability arising from the off-label marketing of the epilepsy drug Topamax.
The settlement arose from two whistleblower cases filed under federal and state False Claims Acts, alleging that Otho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals, Inc., improperly marketed Topamax for psychiatric uses, when it was only FDA-approved to treat epilepsy. Federal laws prohibit drugmakers from marketing drugs for uses other than those specified in drug applications and approved by the FDA.
The complaint alleged that Ortho-McNeil promoted off-label uses of Topamax by hiring physicians to speak at meetings and dinners about prescribing for unapproved uses, and rewarded such physicians with lavish “honorariums”, trips, and tickets to entertainment events.
Under the settlement, the federal government will receive over $50 million and an additional $24 million will be allocated for the state Medicaid share. Additionally, Ortho-McNeil has agreed to plead guilty to a misdemeanor and pay a $6.14 million criminal fine.
The two cases, both filed in the District of Massachusetts are United States ex rel. Maher, et al. v. Ortho-McNeil Pharmaceutical, Civil Action No. 03-11445-WGY, and United States ex rel. Spivack v. Johnson & Johnson and Ortho-McNeil Pharmaceutical, Inc., Civil Action No. 04-11886-WGY. As part of the settlement, the relators will receive a combined $9 million relator’s share.
FHWN attorneys David L. Haron and Monica P. Navarro represented relators Maher and Savka. Phillips and Cohen represented relator Spivack.
To read the settlement agreement, click here.
