US Court of Appeals Rules that Off Label Promotion May Be Treated as Racketeering in Civil Litigation

 Earlier this month, as reported by Reuters, the U.S. Court of Appeals for the First Circuit issued an opinion that may allow third-party payers, such as private insurers, to bring “class-action racketeering claims” against Pfizer for its illegal off-label marketing of Neurontin.  The off-label chargers stem from a $240 million criminal fine in 2004 paid by Pfizer’s Warner-Lambert unit, as well as a $190 million civil fine paid by Pfizer in connection with the off-label marketing.  “Neurontin, developed by a Warner-Lambert unit, was approved in 1993 to treat seizures at a maximum dose of 1800 milligrams per day. Warner-Lambert was later acquired by Pfizer,” Reuters notes.  The Neurontin settlement, one of the earlier off-label cases, was also notable because the settlement provided a $21 million Consumer and Prescriber Education grant program to be administered by a Special Committee of State Attorneys General pursuant to an Oregon Court Order.  This Program funds organizations such as PharmedOut, the National Physicians Alliance, and the Institute for Medicine as a Profession.  The First Circuit’s ruling means that Pfizer may have to pay $142 million (unless it appeals to the U.S. Supreme Court) to cover costs of private insurers, such as Kaiser Foundation Health Plan, which brought one of the cases.  Kaiser claimed that “it had been damaged after prescribing Neurontin for conditions it did not effectively treat, based on fraudulent marketing by Pfizer...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs