Last week, the Vermont Office of the Attorney General (“VT AG”) published 25 enforcement actions recently taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s Prescribed Products Disclosure Law, 18 V.S.A. §§ 4631, 4632. These are the first enforcement actions that the VT AG has made public since the law was first enacted in 2009. Significantly, 24 of the 25 posted enforcement actions relate to the failure of the manufacturer to annually report payments and transfers of value provided to health care professionals (“HCPs”), while one enforcement action relates to a manufacturer’s violation of the law’s gift ban requirements.
The VT AG entered into an Assurance of Discontinuance with each of the 25 manufacturers. Regarding the 24 manufacturers that failed to file the necessary annual reports, the Assurance of Discontinuance requires each manufacturer to comply with the statute going forward and to pay the full registration fee due for the year(s) in which the report was not filed. Although the terms of the Assurance of Discontinuance release and discharge claims against the manufacturer by the VT AG for the failure to report under 18 V.S.A. § 4632, it expressly provides that gift ban violations under 18 V.S.A. § 4631 are not released.
The Assurance of Discontinuance between the VT AG and Novartis Pharmaceuticals lists six meals with HCPs between May 2010 and December 2011 that violate the gift ban, 18 V.S.A. § 4631. As a result, Novartis was required to pay the VT AG civil penalties of $36,000. Notably, it appears that certain information regarding these and other gift ban violations was self-disclosed by Novartis to the VT AG, and that Novartis sought reimbursement from the HCPs for the gift ban violations.