FDA seems to be getting bolder in penalizing industry when it prevents an FDA investigator from taking photographs during a routine FDA inspection. On August 2, 2017, FDA issued a Warning Letter to Homeolab USA Inc. (part of the parent company, Homeocan Inc. located in Montreal, …
Just last month, we blogged about what we believe to be the first Consent Decree signed by the government and an Outsourcing Facility, shutting down operations under judicial order until certain rigorous conditions are met. Now, comes the second. Isomeric Pharmacy Solutions, LLC and three affiliated individuals …
Developing jurisprudence on FCA qui tam (whistleblower) cases, in addition to the important False Claims Act settlement discussed in a recent FDA Law Blog post (here), the First Circuit Court of Appeals issued a decision on July 26 in a case brought against DePuy Orthopaedics, Inc., alleging false …
Some lawyers old enough to remember carbon paper may also remember, in their archaic law school teaching, the “eggshell plaintiff” rule, accurately described as “a maxim that a tort defendant takes his victim as he finds him.” Also referred to as the “eggshell skull rule,” …
In the absence of blogworthy FDA regulatory pronouncements (draft regulations, draft guidances, and oxymoronically named “tentative final rules”), material for FDA Law Blog posts is harder to come by these days (meaning, since President Trump’s inauguration, not coincidentally). Now comes across our computer screen a …
By John R. Fleder, Douglas B. Farquhar & Peter M. Jaensch – The U.S. Department of Justice announced on November 9, 2010, the government version of a six-count indictment filed in the District of Maryland against Lauren Stevens, a former Vice President and Associate General Counsel for a brand …
By John R. Fleder, Douglas B. Farquhar & Ricardo Carvajal – The U.S. Attorney for the Eastern District of California (Sacramento) has announced guilty pleas by two individuals for fraudulent activities in connection with their distribution of tomato products. Allegedly at the direction of her superiors …
By John R. Fleder, Douglas B. Farquhar & Ricardo Carvajal – FDA has obtained summary judgment and an order of permanent injunction against a Minnesota seafood supplier that was found to have had an inadequate HACCP plan for more than three years, in violation of FDC …
