The thought of federal agents storming the offices of an FDA-regulated company may seem far-fetched to some, but it is becoming a common reality, according to Hyman, Phelps & McNamara, P.C. attorneys John R. Fleder and William T. Koustas in a recent article in FDLI's Update publication. …
By JP Ellison – Today Attorney General Eric Holder and HHS Secretary Kathleen Sebelius announced the creation of a new interagency effort, the Health Care Fraud Prevention and Enforcement Action Team (HEAT), to combat healthcare fraud. Medicare appears to be the primary focus of the …
By JP Ellison – On May 18, 2009 the U.S. Department of Justice and sixteen states announced that they had intervened in whistleblower (qui tam) lawsuits pending in federal district court in Massachusetts against drug manufacturer Wyeth, alleging false claims act violations under federal and …
By Wes Siegner & Ricardo Carvajal – FDA has issued a warning letter to General Mills in which the agency alleges “serious violations” of the FDC Act in the label and labeling of Cheerios cereal. Specifically, FDA contends that the following label claims make Cheerios …
By Ricardo Carvajal – On May 11, FDA announced the condemnation and forfeiture of $1.3 million worth of dietary supplements marketed to body builders because the supplements contain “one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to …
By Christine P. Bump – The State of New Jersey announced this week that it had entered into a landmark agreement with Synthes, Inc. to settle allegations that Synthes failed to disclose financial conflicts of interest among doctors who conducted clinical testing on its products. Synthes …
By Ricardo Carvajal – At its public meeting on economically motivated adulteration ("EMA"), FDA got no shortage of suggestions on how to better prevent, detect, and address instances of EMA. FDA called the meeting “to stimulate and focus discussion about ways in which the food …
By Ricardo Carvajal & John R. Fleder – In Federal Trade Commission v. Medlab, Inc., the United States District Court for the Northern District of California granted summary judgment on April 21, 2009, to the FTC in an action against a marketer of weight loss products, which …
By William T. Koustas – On April 20th, the Federal Trade Commission ("FTC") announced that it has brought, and at the same time tentatively settled, charges of false advertising brought under the FTC Act against Kellogg, the world’s largest cereal maker. The FTC accused Kellogg …
By William T. Koustas – On April 15th, the Department of Justice announced that the U.S. has entered into a global criminal and civil settlement with Quest Diagnostics Inc. (“Quest”) and its subsidiary Nichols Institute Diagnostics (“NID”). NID pleaded guilty to a felony charge of misbranding …
By Kurt R. Karst – We previously reported on FDA’s recent drug-based marketed unapproved drug enforcement action concerning certain narcotics. In that case, FDA issued 9 Warning Letters to companies concerning 14 narcotic drug products, including morphine sulfate, hydromorphone, and oxycodone. Late on April 9, 2009, FDA …
By JP Ellison – In U.S. v. Palazzo, the Fifth Circuit recently reversed a trial court’s decision to dismiss criminal charges against a clinical investigator based upon violation of 21 C.F.R. § 312.62(b), which requires such investigators “to prepare and maintain adequate and accurate case …
In the latest “Enforcement Corner” column for the Food and Drug Law Institute’s Update publication, Hyman, Phelps & McNamara, P.C. attorneys JP Ellison and John R. Fleder discuss the indictment, trial, conviction, and sentencing of Berkeley Nutraceuticals’ former in-house counsel Paul Kellogg. Mr. Kellogg’s conviction …
By Kurt R. Karst – Earlier today, FDA announced that the Agency has taken enforcement action against several manufacturers of unapproved prescription narcotics. The 9 Warning Letters issued by FDA concern 14 narcotic drug products, including morphine sulfate, hydromorphone, and oxycodone. The Warning Letters direct …
By Jennifer B. Davis & John R. Fleder – In a March 17, 2009 opinion in United States ex rel Roop v. Hypoguard USA, Inc., the United States Court of Appeals for the Eighth Circuit held that the Relator’s qui tam allegations concerning Defendant’s alleged failure to …
