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 …
Last month, the U.S. Court of Appeals for the Fourth Circuit held that the whistleblower protection provisions of the Sarbanes-Oxley Act, 18 U.S.C. § 1514A, did not protect a former employee of Wyeth who alleged that he was fired for complaining to Wyeth management about …
The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Riëtte van Laack and John R. Fleder discusses a recent court ruling showing the potential perils faced by a company and its officers who aggressively defend their position. In United States v. Kaminski, the …
On February 27, 2008, the U.S. Court of Appeals for the Seventh Circuit issued a decision in United States v. Caputo, in which the court generally affirmed a “complex and unusual” district court decision holding criminally liable a corporate Chief Executive Officer (“CEO”) and, remarkably, …
Over the past several weeks, FDA Law Blog has closely followed issues concerning the United States Sentencing Commission’s proposed changes to the Sentencing Guidelines that are applicable to certain FDA criminal offenses. In our most recent post, we reported on a February 13, 2008 public …
Last week, FDA announced a consent decree of permanent injunction had been entered into with two food companies – Brownwood Acres Foods, Inc. and Cherry Capital Services, Inc. (doing business as Flavonoid Services) – and their top executives, prohibiting them from making unauthorized drug and …
On February 7, 2008, the U.S. Department of Justice announced that Merck & Company, Inc. (“Merck”) agreed to pay more than $650 million to settle allegations that the company failed to pay proper rebates to Medicaid and paid illegal remuneration to health care providers to …
Yesterday, we reported that two Hyman, Phelps & McNamara, P.C. attorneys appeared on February 13, 2008, before the United States Sentencing Commission (“Commission”) regarding possible changes to the Sentencing Guidelines (“Guidelines”) that are applicable to certain FDA criminal offenses. That same day, three FDA officials …
We previously reported on the United States Sentencing Commission’s (“Commission”) proposed changes to its Sentencing Guidelines (“Guidelines”) that would likely greatly enhance the criminal penalties applied to some criminal violations of the FDC Act, including those added by the Prescription Drug Marketing Act of 1987 …
The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Gwen M. McKee and John R. Fleder discusses the enforcement provisions of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). While the enforcement provisions of FDAAA have frequently been ignored in public …
The Food and Drug Law Institute is scheduled to hold its 6th Annual Conference on Enforcement and Litigation on February 19-20, 2008. Among other topics of discussion slated for the conference are the U.S. Sentencing Commission’s proposed guidelines that would greatly enhance the criminal penalties …
The United States Sentencing Commission (“Commission”), which sets the guidelines that are usually followed by federal judges sentencing defendants convicted of federal crimes, has issued proposed Sentencing Guidelines (“Guidelines”) that would likely greatly enhance the criminal penalties applied to some criminal violations of the Federal …
