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Pharmaceutical Industry › Off-Label Use › Whistleblowers

Saul Ewing LLP

Ninth Circuit, in Solis, Reaffirms Two-Prong Approach to “Original Source” Exception Under Former FCA

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The Ninth Circuit recently reversed in part the district court’s dismissal of relator Frank Solis’ claims against his former employers for alleged False Claims Act (“FCA”) violations. According to Solis, the drug companies...more

Holland & Knight LLP

Healthcare Law Update: December 2016

Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

Proskauer - Whistleblowing & Retaliation

In 10-1 Verdict, Jury Finds No FCA Violation by Abbott Laboratories

Proskauer - Whistleblowing & Retaliation on

On April 7, 2016, after just three hours of deliberations following a three-week trial, a federal jury dismissed False Claims Act (“FCA”) claims against Abbott Laboratories brought by a whistleblowing former employee.  The...more

Saul Ewing LLP

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

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Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

Epstein Becker & Green

Supreme Court Declines to Opine on Circuit Split Over Rule 9(b) Pleading Requirements for FCA Claims

Epstein Becker & Green on

On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more

Saul Ewing LLP

Court enforces False Claims Act’s first-to-file rule to bar complaint alleging details of off-label promotion scheme about which...

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In Brief - When an alleged scheme to market drugs for unapproved “off-label” uses had already been identified by an earlier complaint, a later complaint providing additional details, but alleging the same “essential...more

Bradley Arant Boult Cummings LLP

False Claim Act: 2013 Year in Review

Bradley Arant Boult Cummings LLP on

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

Patterson Belknap Webb & Tyler LLP

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

Patterson Belknap Webb & Tyler LLP on

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

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