Fighting Off-Label Qui Tam Suits: Have Federal Courts Encouraged Filing Of Speculative FCA Claims?


Pharmaceutical and medical device companies that would like to discuss off-label uses of their FDA approved products with health care professionals face a treacherous path paved with substantial uncertainty, including the threat of criminal enforcement and civil lawsuits under the False Claims Act (FCA), 31 U.S.C. §§ 3729-33. This LEGAL BACKGROUNDER will focus on recent judicial decisions on the application of Federal Rule of Civil Procedure 9(b) to FCA lawsuits against health care companies, and their potential impact on the important gatekeeper function that Rule 9(b) serves to screen out speculative complaints in cases alleging fraud.

Please see full article below for more information.

LOADING PDF: If there are any problems, click here to download the file.

Written by:

Published In:

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morrison & Foerster LLP | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name.