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 …
We previously reported (April 25, 2007, May 22, 2007, August 14, 2007) on a trend in policing promotional and advertising claims by FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”), in which DDMAC has focused on ensuring that all claims are supported by substantial …
The latest FDLI Update “Enforcement Corner” article by Hyman, Phelps & McNamara, P.C. discusses the fact that government entities, including FDA, are taking enforcement actions against companies that market cosmetics and cosmetic-like products. The article highlights recent enforcement actions in this area, and also notes …
In United States v. Stein, the United States Court of Appeals for the Second Circuit recently upheld a lower court’s decision to dismiss charges against former employees of KPMG on the basis that the prosecutors interfered with the employees’ constitutional right to counsel. Ex-employees of …
According to the Associated Press, a federal court has sentenced Steven Warshak, founder of Berkeley Premium Nutraceuticals, to 25 years in prison for crimes including mail fraud, conspiracy to commit fraud, and money laundering. In addition, Warshak and other defendants must forfeit money and assets …
On August 8, 2008, the U.S. Court of Appeals for the Third Circuit issued an opinion in an appeal from a conviction under, among other provisions, the criminal provisions of the Federal Food Drug and Cosmetic Act (“FDC Act”). A jury convicted Eric Goldberg of …
A recent Federal Trade Commission (“FTC”) action serves as a reminder that the agency takes seriously cases referred to it by the National Advertising Division of the Council of the Better Business Bureaus (“NAD”). In a press release issued earlier this week, the FTC announced …
The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’ s Gwendolyn M. McKee and John R. Fleder discusses the potential consequences to company executives and companies of submitting false information to a government agency, even when the submission is not made under oath. …
As widely reported earlier this month, FDA and the Department of Justice (“DOJ”) intensified their investigation of Indian drug company Ranbaxy, Inc. On July 3, 2008, the government moved to enforce administrative subpoenas directed at Ranbaxy and the company’s consultant, PAREXEL Consulting concerning information about …
In a case involving a highly unusual set of facts for FDA-regulated companies, Leiner Health Products, Inc. (Leiner) is seeking to have a plea agreement approved by a Bankruptcy court. The case involves violations of Current Good Manufacturing Practices (cGMPs) for over-the-counter drugs. What also …
The latest issue of the Food and Drug Law Institute’s “Update” magazine features articles written by three Hyman, Phelps & McNamara, P.C. attorneys. The first article, titled “FDA Moves Against Marketed Unapproved Human Drugs,” was written by Susan J. Matthees and John R. Fleder and …
On May 1, 2008, a federal judge in the Middle District of Florida brought some measure of closure to FDA’s more than six years of attempts to regulate a self-identified custom device manufacturer. In his May 1st order, Judge G. Kendall Sharp mostly sided with …
As we previously reported (see post here and article here), FDA has been seeking stiffer sentences under the U.S. Sentencing Guidelines for at least the past five years. For the preceding four years, the FDA’s pleas seemed to fall on deaf ears, but in this …
