Judge Rejects Plea Agreement In Guidant Heart Device Criminal Case

MINNEAPOLIS - (Mealey's) Guidant LLC's proposed plea agreement to pay a criminal fine of $254,962 and criminal forfeiture of $42,079,675 for charges that it twice violated the Food, Drug and Cosmetic Act (FDCA) by submitting false or no information about changes made to its Prizm and Renewal...

D.C. Circuit: E-Cigarettes Are Tobacco Products, Not Medical Devices

WASHINGTON, D.C. - (Mealey's) Electronic cigarettes, which deliver a dose of nicotine vapor without flame or smoke, are for regulatory purposes tobacco products, not medical devices, the District of Columbia Circuit U.S. Court of Appeals ruled Dec. 7 ( Sottera, Inc., et al. v. U.S. Food and Drug...

Free Download: Keller & Heckman Litigation Alert: 8th Circuit Finds Adulterated Drug Claims Not Preempted

Consumers can sue a drug company for selling a drug that was not manufactured pursuant to good manufacturing practices (GMP) and was, thus, "adulterated" under the Food, Drug and Cosmetic Act (FDCA). Such claims are not preempted by federal law, said the Eighth Circuit Court of Appeals. ( Allen...