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Drug & Device Law

Another Guest Post on Rostholder FCA Developments

By Bexis
October 10, 2014

Back in February, we hosted a guest post about United States ex rel. Rostholder v. Omnicare, Inc., 745 F.3d 694 (4th Cir. 2014), an extremely important False Claims Act (“FCA”) decision for the defense-side’s effort to prevent the FCA from being converted…

Meaningful Discussions

Supreme Court Denies Cert in Highly Watched FCA Case—Regulatory Violation Must Be Related to Claim for Payment

By Marcia Madsen & Michelle E. Litteken
October 8, 2014

iStock_000035162090LargeThis week, the Supreme Court denied the qui tam plaintiff’s petition for certiorari in United States ex. Rel. Rostholder v. Omnicare, Inc., a False Claims Act (FCA) case from the Fourth Circuit. In Omnicare, the relator alleged that…

Life Sciences Legal Update

Omnicare’s Appellate Victory Upheld by U.S. Supreme Court

By Lisa Baird
October 8, 2014

The February 2014 decision (discussed in an earlier blog post) in which the U.S. Court of Appeals for the Fourth Circuit dismissed the False Claims Act (FCA) charges brought in United States ex rel. Rostholder v. Omnicare, Inc. was…

Focus on Regulation

Fourth Circuit Holds That cGMP Deficiencies Alone Do Not Constitute A False Claims Act Violation

By Virginia Gibson, Eliza Andonova & Jim Johnson
March 7, 2014

For several years now current good manufacturing practice (cGMP) violations have been viewed as “the next hot thing” in False Claims Act (FCA) litigation.  The $750 million settlement involving SB Pharmaco (a GlaxoSmithKline subsidiary) and the $500 million settlement involving…

Global Regulatory Enforcement Law Blog

Federal Appeals Court Rejects False Claims Act Suit Based on Drug Packaging cGMP Violations

By Colin Wrabley, Eric Dubelier, Lawrence Sher, Mel Beras & Kate Seikaly
February 28, 2014

This post was also written by James C. Martin.

Recently the U.S. Court of Appeals for the Fourth Circuit affirmed the district court’s dismissal of the relator’s False Claims Act (FCA) complaint against Omnicare in United States ex rel. Rostholder…

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