News & Analysis as of

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

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

False Claims Act Litigation Update: Bayer Decision Sheds Light on Pleading in False Claims Act Cases

A recent win for a large company in a False Claims Act suit (a seeming rarity as of late) alleging illegal off-label promotion could provide some helpful insight to similarly situated manufacturers and support dismissals of...more

After Arkansas Supreme Court Reverses $1.2 Billion Medicaid False Claims Verdict, Will State Attorneys General Rethink the Use of...

On March 20, 2014, the Arkansas Supreme Court reversed a $1.2 billion judgment against Johnson & Johnson and its related companies over alleged Medicaid fraud stemming from the off-label marketing of the drug Risperdal. This...more

Biotech Company to Pay over $22 Million for Marketing Off-Label Use of Products

Two whistleblowers used the qui tam provisions of the False Claims Act (FCA) to file lawsuits against biotechnology company Genzyme Corp. for teaching doctors and other medical staff how to create a "slurry" version of its...more

Unsealed Qui Tams Show That Government Declination is Not Always the End

Mintz Levin’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides focused analysis of four health care-related qui tam cases in which the government declined to intervene, including...more

Hodgson Russ Helps Clients in Largest-Ever False Claims Act Settlement In Risperdal Lawsuits Against Johnson & Johnson

The Justice Department announced that Johnson & Johnson will pay $1.273 billion to the federal government and most states to settle a civil False Claims Act investigation into its off-label marketing of its antipsychotic drug...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed Cases

Trends and Analysis: ..We have identified 21 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, two were filed in 2013, 15 were filed in 2011 or 2012, and four were filed in 2010 or...more

Is Filling an Off-Label Prescription an Invitation to False Claims Act Liability?

On May 17, 2013, the U.S. District Court for the Northern District of Georgia issued an order that joins an unsettling line of decisions suggesting that before filling prescriptions, pharmacies must serve as the arbiters of...more

False Claims Act Focus - April 2013

EDITOR’S NOTE - The last few months have not failed to provide interesting False Claims Act (FCA) activity in the courts. We begin our newsletter by examining a case brought in the energy sector, alleging that a...more

Health Care Enforcement in 2012: A Year in Review

Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more

Fourth Circuit Holds False Claims Act Relators to Strict Pleading Standard: Ruling Will Be Particularly Useful in Defending...

On January 11, 2013, the United States Court of Appeals for the Fourth Circuit issued an opinion reaffirming the requirement that False Claims Act relators plead presentment of a false claim with particularity. United States...more

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

2013 Enforcement Predictions

I always like to make predictions at the beginning of each year. My track record is plus and minus – sometimes on target, sometimes off-target. The biggest story in the last five years has been the rise of FCPA...more

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