Pradaxa and Actos: Is Non-Preservation of Documents an Emerging Trend?

When a US District Court judge fined Boehringer Ingelheim almost $1 million at the end of last year for failure to preserve documents regarding the blood thinner Pradaxa, the decision served as a precursor to a similar position taken by the Court in regards to the Actos portfolio. The Actos manufacturer, Takeda Pharmaceuticals, was cited […]

Misbranding Depakote

A recent headline announced that Abbott Laboratories must pay over $1.6 million for misbranding the prescription drug Depakote. The total included a criminal fine and civil settlements with the states and federal government. In addition, Abbott has agreed to pay 45 states in order to resolve liability under state consumer-protection laws. Acting Associate Attorney General […]

FDA’s Special Report on Product Safety and Quality

The U.S. Food and Drug Administration (FDA) recently issued a special report on product safety and quality designed to meet the challenges imposed by the increasing number of FDA-regulated imports and a complex global supply chain. The special report, entitled Pathway to Product Safety and Quality, reports that between 10 and 15% of all food […]