Blog

SCOTUS Declines to Revisit Third Circuit Decision Containing Expansive Construction of Public Disclosure Bar

On October 7, 2019, the Supreme Court (SCOTUS) denied certiorari in the matter of Pharmerica Corporation v. U.S. ex rel. Silver, leaving on the books the Third Circuit decision which held that the False Claims Act's (FCA) public disclosure bar "is not implicated . . . where a relator's non-public information permits an inference of fraud that could not have been supported by the public disclosures alone[.]" This holding arguably...

Timely Reporting of Disciplinary Actions: It Goes Beyond Just Other State Boards of Pharmacy

We've all heard the examples where failure to notify one state's Board of Pharmacy of disciplinary action imposed by another state's Board of Pharmacy has had a cascading effect, resulting in spiraling and circuitous fines and discipline. However, did you know that failure to provide timely notification of discipline (and other actions) can have PBM implications as well? Many PBM manuals contain sections detailing the obligation to report disciplinary actions,...

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...

Pharmacy ALERT: Pharmacies Receive Subpoenas Regarding RDC Contracts

State and local governments across the country have taken the opioid crisis head-on, many of them filing civil lawsuits against opioid manufacturers, wholesalers, distributors and healthcare providers. As part of these lawsuits, plaintiffs have been issuing subpoenas to pharmacies that purchased products, including opioids, from wholesalers and distributors, such as Rochester Drug Co-Operative, Inc. (RDC). The subpoenas request numerous documents and often require a significant amount of time and resources...

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...