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States Reach Settlement with Reckitt Over Allegations of Improper Marketing of Suboxone

On October 23, 2019, the New York Attorney General's Office announced that New York and other states have reached a civil settlement agreement with Reckitt Benckiser Group (Reckitt) to settle allegations that the pharmaceutical distributor improperly marketed and promoted Suboxone (approved opioid addiction treatment) resulting in improper expenditure of Medicaid funds. Reckitt agreed to pay $700 million to settle the allegations, including those it settled with the U.S. earlier this...

Frier Levitt Successfully Defends Pharmacy Facing Change of Ownership Penalties by the State Board of Pharmacy

Recently, Frier Levitt successfully represented a pharmacy facing penalties, probation or suspension for failure to timely notify a state board of pharmacy of a change of ownership, among other allegations. With the matter was set for a hearing before the Board, Frier Levitt contacted the Board explaining that our client had recently gone through a merger and management changes and had just established a compliance department. In light of these...

Manufacturer ALERT: DEA Announces Proposed Regulations to Combat Opioid Crisis

In an effort to address the national opioid crisis, the Drug Enforcement Administration (DEA) recently announced proposed regulations to improve oversight of the production of dangerous drugs that might be vulnerable to diversion.  The DEA's proposal amends the manner in which the DEA grants quotas to manufacturers for maintaining inventories and introduces several new types of quotas that DEA would grant to certain DEA-registered manufacturers. The proposed regulations incorporate important...

Manufacturer ALERT: False Claims Act Violation for Selling Unapproved Medical Devices

On September 13, 2019, Manhattan U.S. Attorney for the Southern District of New York announced that the Government has simultaneously filed and settled a civil fraud lawsuit under the False Claims Act against Avalign Technologies, Inc. (Avalign) and its subsidiary, Instrumed International, Inc. (Instrumed), for manufacturing and selling medical devices that were not cleared by the U.S. Food and Drug Administration (FDA.) As part of the settlement, Avalign and Instrumed...

Mallinckrodt Agrees to Pay $15.4 Million to Resolve Alleged False Claims Act Liability for “Wining and Dining” Doctors

On September 4, 2019, the United States Department of Justice (DOJ) announced that drug maker Mallinckrodt agreed to pay $15.4 million to resolve claims that its predecessor Questcor Pharmaceuticals paid illegal kickbacks to doctors to induce prescriptions of Questcor's drug H.P. Acthar Gel from 2009 to 2013. The Government intervened in these two whistleblower suits entitled United States of America ex rel. Strunck et al. v. Mallinckrodt ARD, Inc., No....
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