GlaxoSmithKline to Pay $3 Billion in Settlement with Government

On July 2, 2012, GlaxoSmithKline (“GSK”) announced its intention to plead guilty in its ongoing healthcare fraud case in what will result in the largest settlement of its kind in the United States. In particular, the pharmaceutical giant will be …

Marshals Seize Misbranded Drug Products at Maine Facility per FDA’s Request

On June 6, 2012, the U.S. Food and Drug Administration (“FDA”) announced the seizure of various drug products from a Portland, Maine facility. According to the FDA, U.S. Marshals seized the drug products upon the Agency’s request after it was …

FDA Alerts Consumers of an Array of Dangers Associated with Reumofan Plus Supplement

On June 1, 2012, the U.S. Food and Drug Administration (“FDA”) issued an alert to consumers on the product Reumofan Plus. Purportedly marketed as a dietary supplement, Reumofan Plus is manufactured in Mexico by the company Riger Naturals. According to …

U.S. Marshals Seize Products from California Firm upon FDA ’s Repeated Finding of Violations

On May 22, 2012, the U.S. Food and Drug Administration (“FDA”) announced that U.S. Marshals, acting at the requests of the Agency, had seized certain products deemed to be unapproved new drugs. HybriSil (methylprednisolone acetate 1% in silicone gel), the …

FTC May Have Won Battle with POM Wonderful but Industry Appears to Have Won the War

On May 21, 2012, the Federal Trade Commission (“FTC”) announced that it has prevailed in its claim against POM Wonderful LLC (“The Company”) pursuant to a recent ruling by Chief Administrative Law Judge (“ALJ”), D. Michael Chappell. In an Order …

FDA Warns Companies Marketing Supplements Containing DMAA

On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to several dietary supplement manufacturers in connection with their alleged improper marketing of supplements containing dimethylamylamine (“DMAA”). DMAA, also referred to as geranium extract, is an …

FDA Enters into Consent Decree with Seafood Processor over Alleged Manufacturing Deficiencies

On April 11, 2012, the U.S. Food and Drug Administration (“FDA”) announced that, with the aid of the Department of Justice, it has entered into a consent decree with a California seafood processor. The consent decree precludes the company from …

FDA Enters Into Consent Decree of Permanent Injunction with Cheese Producer Due to Listeria Contamination

On April 9, 2012, the U.S. Food and Drug Administration (“FDA”) announced it has entered into a consent decree with a Washington State cheese producer. The company, Del Bueno, which processes and distributes cheeses, and its owner Jesus Rodriguez, agreed to …