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 …
By James P. Ellison – The relationship between the federal government and qui tam relators is defined in part by statute and case law, but that law does not fully capture the often complex and varying relationship between qui tam relators and the government on …
By John R. Fleder & Kurt R. Karst – Last week, the United States District Court for the Eastern District of Pennsylvania entered a Consent Decree against giant home shopping retailer QVC, Inc. The Consent Decree stems from a June 14, 2000 Federal Trade Commission (“FTC”) decision …
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 …
By Kurt R. Karst – Earlier today, FDA announced that the Agency was taking the unusual step of invoking its Application Integrity Policy (“AIP”) against Ranbaxy Laboratories Limited’s (“Ranbaxy”) Paonta Sahib manufacturing facility in India. FDA takes such regulatory action under the Agency’s AIP procedures …
By James P. Ellison – We previously reported on FDA's Federal Register notice adjusting its civil penalties for inflation and noted our prior posts on the new civil penalty authority given to FDA in the FDA Amendments Act. As we explained in our earlier post, FDA's …
By J.P. Ellison – Twenty-Seven Attorneys General have given FDA prior approval authority over Bayer’s Direct-to-Consumer (“DTC”) television and print advertising for its prescription oral contraceptive Yaz, and also required to company to run a $20 million corrective advertising campaign as part of a settlement agreements with …
The latest issue of the Food and Drug Law Institute’s “Update” magazine features articles written by four Hyman, Phelps & McNamara, P.C. attorneys. The first article, titled “Imported Products – FDA Is Not Fooling Around,” was written by Dara Katcher Levy and John R. Fleder. It …
By James P. Ellison – The Department of Justice announced a $1.415 billion settlement with Eli Lily and Company (“Lilly”) to resolve allegations of off-label promotion of the antipsychotic drug Zyprexa (olanzapine). The criminal component of this global settlement is a $515 million fine and …
By James P. Ellison – FDA’s November 12, 2008 Federal Register Notice of its Direct Final Rule to comply with the Federal Civil Penalties Inflation Adjustment Act, 28 U.S.C. § 2461 note, is not in itself a blogworthy event, but it could be part of …
By Bryon F. Powell – On November 4, 2008, the United States District Court for the Middle District of Florida granted Defendants AstraZeneca’s and Parexel’s Motions to Dismiss in Ironworkers Local Union No. 68 v. AstraZeneca Pharmaceuticals LP. In this case, the Plaintiffs, various union …
