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False Claims Act
Fresenius to the U.S. Government: When It Comes to the FCA, You Snooze You…
In a nearly decade long lawsuit involving the dialysis company Fresenius, and allegations that the company violated the False…
False Claims Act Mid-Year Review: Significant Life Science Settlements,…
Several significant False Claims Act settlements and judgments in the first six months of 2017 suggest this year will result in…
FDA Warns Cipher Over “Misleading” Marketing Materials
The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter to Cipher…
DOJ Announces Another FCA Settlement – Sightpath Medical and TLC…
In late August 2017, the United States Department of Justice (DOJ) announced a $12 million settlement with Sightpath Medical and…
Punting on the Issue of FCA and Statistical Sampling
In a much-anticipated U.S. Court of Appeals decision, the Fourth Circuit on February 14, 2017, in evaluating the issue of whether…
Pharmaceutical and Device Manufacturers: Buyer Seller Beware
Pharmaceutical and medical device manufacturers continue to face intense scrutiny from regulatory and enforcement agencies, as…
Genentech Beats FCA Suit, Thanks to Escobar
On Monday, May 1, 2017, the United States Court of Appeals for the Third Circuit stopped a False Claims Act suit that accused…
Going Back to the Roots of the False Claims Act – Baxter Settles cGMP…
While False Claims Act cases are relatively common in the life science industry, FCA cases for cGMP violations are not. This…
DOJ Has Third Highest Annual Recovery in FCA History
The United States Department of Justice has announced the fiscal year 2016 recoveries from civil False Claims Act. This…
Department of Justice Increases FCA Civil Penalties, Again
On February 3, 2017, the Department of Justice (DOJ) announced that False Claims Act (FCA) penalties will once again be…