Category Archives: Off Label

Seventh Circuit Bars RICO Claims by Third-Party Payors Against Drug Companies Based on Off-Label Promotion

On October 12, 2017, in Sidney Hillman Health Center of Rochester v. Abbott Laboratories, —F.3d —-, 2017 WL 4544834 (7th Cir. 2017), the Seventh Circuit affirmed the dismissal of a civil RICO class action by third-party payors against drug manufacturer Abbott Laboratories. The decision appears to completely foreclose payors’ suits against drug companies for off-label promotion under the Racketeer Influenced and Corrupt Organizations Act (RICO) and potentially signals a bar against tort claims of any kind by payors against drug companies for off-label…

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Shifting Regulatory Landscape for Off-Label Promotion Continues

On Wednesday, July 12, 2017, the Health Subcommittee of the Energy and Commerce Committee held a hearing to discuss proposed legislation that would impact the regulation of off-label use and promotion for drug products. There were representatives from all facets of the industry discussing the potential impact of decreasing regulation of off-label use of drugs and how it could affect patients, the public, manufacturers, and the economy. The FDA last solicited public comment on the issue of off-label use over six years ago, and the…

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Green Light for Aetna in RICO Suit

On April 3, 2013, the First Circuit held that Aetna, Inc. can sue Pfizer, Inc. for its off-label marketing of Neurontin®.  Neurontin® was approved for the treatment of epilepsy, but was allegedly marketed for the treatment of bipolar disorder and neuropathic pain in the mid 1990’s.  Aetna brought RICO and Pennsylvania Insurance Fraud Statute claims based on the off-label marketing. In reinstating the case, the Court found that the plaintiffs were not required to prove that the doctor’s off-label prescriptions were caused by the off-label…

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