News & Analysis as of

Public Disclosure Medical Devices

Healthcare Fraud and Abuse Review 2016

by Bass, Berry & Sims PLC on

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

AGG Food and Drug Newsletter - February 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

D.Mass. Invokes Public Disclosure Bar, Demands Specificity, and Refuses to Second-Guess FDA in Dismissing Axium/Onyx Qui Tam Case

by Reed Smith on

It’s not as if the standard for amending pleadings is a particularly hot DDL topic, but here we go for the second time this week discussing a case where precisely that was at issue. This time the case was U.S. ex rel....more

D.Mass. Invokes Public Disclosure Bar, Demands Specificity, and Refuses to Second-Guess FDA in Dismissing Axium/Onyx Qui Tam Case

by Reed Smith on

It’s not as if the standard for amending pleadings is a particularly hot DDL topic, but here we go for the second time this week discussing a case where precisely that was at issue. This time the case was U.S. ex rel....more

Recent Ninth Circuit En Banc Decision Makes It Easier for Relators to be an Original Source and the First- to-File

by Ropes & Gray LLP on

On July 7, 2015, the United States Court of Appeals for the Ninth Circuit issued an en banc decision that potentially makes it easier for relators to prevail on pending False Claim Act qui tam suits and bring new actions in...more

9th Circ. Relaxes Requirements for “Original Source” Whistleblowers

by Faegre Baker Daniels on

The False Claims Act makes it illegal to obtain government money through false claims. Under the Act a private party, known as a relator, may bring a civil suit on the government’s behalf against an entity that has allegedly...more

Eighth Circuit Dismisses Whistleblower's Suit Finding Facts Were Already Publicly Disclosed

by Foley & Lardner LLP on

In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for...more

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