Earlier this year, Gerald M. Sacks, MD, reached a settlement agreement with the United States Department of Justice (DOJ) over allegations that he violated the False Claims Act. The DOJ alleged that Dr. Sacks prescribed several medications for receiving paid speaking and consulting work from two pharmaceutical manufacturers, Purdue Pharma, LP and Depomed Inc. Sacks agreed to pay $270,582.63 (including $202,963.83 in restitution).
The Allegations
According to the government, Sacks prescribed Purdue’s medications Butrans, Hysingla, and OxyContin, all opioid medications for the treatment of pain, to Medicare beneficiaries, in part for exchange for receiving paid speaking and consulting work from Purdue from December 13, 2010 through October 31, 2021.
The DOJ also alleged that Sacks prescribed Gralise (a nerve pain medication) as well as Lazanda and Nucynta (opioid medications for the treatment of pain) to Medicare beneficiaries in exchange for receiving paid speaking and consulting work from Depomed, from January 1, 2016 to December 31, 2016.
According to the Open Payments database, Depomed (now known as Assertio Therapeutics, Inc) paid Sacks $59,748.24 in general payments during 2016 while Purdue paid Sacks $74,493.83 in general payments for all years available in the database (currently 2016 through 2021).
No Wrongdoing and Future Cooperation
Dr. Sacks denied the allegations made by the DOJ and the settlement agreement is not an admission of liability by Dr. Sacks or a concession by the United States that the claims are not well-founded.
As part of the settlement, Sacks also agreed to cooperate fully and truthfully with the United States’ investigation of individuals and entities not released in the Settlement Agreement. He further agreed to encourage – and not impair – the cooperation of others, consistent with the rights and privileges of such individuals, upon reasonable notice. Additionally, upon request, he shall furnish to the United States complete and unredacted copies of all non-privileged documents related to the Covered Conduct.
Additionally, Depomed (nor Assertio) have been accused by the government of wrongdoing. Purdue has long been involved in legal trouble surrounding its Anti-Kickback Statute violations.
“Physicians are prohibited from accepting kickbacks designed to influence their decisionmaking,” said Deputy Assistant Attorney General Michael D. Granston of the Justice Department’s Civil Division. “Adherence to this prohibition is especially crucial with regard to dangerous drugs like opioids.”