Please E-mail suggested additions, comments and/or corrections to Kent@MoreLaw.Com.
Date: 04-20-2023
Case Style:
Case Number:
Judge: Not Assigned
Court: United States District Court for the District of Massachusetts (Suffolk County)
Plaintiff's Attorney: United States Attorney’s Office in Boston
Defendant's Attorney:
Description: Boston, Massachusetts civil litigation lawyers represented Defendant accused of receipt of misbranded drugs.
“Greater Boston Behavioral Health disregarded laws designed to protect patient safety,” said United States Attorney Rachael S. Rollins. “The U.S. Attorney’s Office is committed to protecting patients and the integrity of federal health care programs, and we will continue to use our criminal authority to ensure that health care providers play by the rules that protect the public and ensure quality of care.”
“Administering misbranded prescription drugs to patients puts their health at risk,” said Special Agent in Charge Fernando P. McMillan, FDA Office of Criminal Investigations New York Office. “We will continue to pursue and bring to justice those who jeopardize the public’s health.”
Pursuant to a criminal information filed in federal court in Boston, the United States charged Greater Boston Behavioral Health with violations of the Food, Drug and Cosmetic Act. As part of the criminal resolution, Greater Boston Behavioral Health has agreed to plead guilty to a misdemeanor offense, to pay a criminal fine of $657,678 and to forfeit $1,929,464.
According to the criminal information, Greater Boston Behavioral Health sought out sources from which it could purchase Botox® that was packaged and labeled only for sale in the United Kingdom and other foreign countries. The label of the foreign Botox purchased by Greater Boston Behavioral Health differed from the FDA-approved label for Botox and Botox Cosmetic and lacked the designation “Rx Only” as required by the FDCA for prescription drugs. The label also typically did not include the FDA-required “black-box warning” concerning potential side-effects of Botox. Greater Boston Behavioral Health purchased foreign Botox at prices significantly below the price that Allergan and its authorized distributors charged for Botox and Botox Cosmetic that was manufactured and labeled for sale in the United States.
Doctors at Greater Boston Behavioral Health used the foreign Botox to treat patients suffering from migraine headaches and did not disclose to these patients that they purchased the drug from foreign sources or that it was not labeled for distribution in the United States.
U.S. Attorney Rollins and FDA-OCI SAC McMillan made the announcement today. Assistant U.S. Attorney Christopher Looney of Rollins’ Health Care Fraud Unit handled the matter.
Outcome: Defendant agree to pay $2.5 million to settle claims at it purchsed Botox that was packaged and labeled for use only in foreign countries.
Plaintiff's Experts:
Defendant's Experts:
Comments: