By Kurt R. Karst – Earlier today, FDA sent a letter to Senator Charles Grassley (R-IA) indicating that the Agency may very well be poised to increase prosecution of company officials. According to the letter, which includes several recommendations based on a committee the Agency formed …
The Washington Legal Foundation has published a Legal Opinion Letter authored by Hyman, Phelps & McNamara, P.C., attorneys Jeffrey N. Wasserstein and Nisha P. Shah. The article, with the catchy title "Court Empowers Qui Tam Defendants To Sue Third Parties For Indemnification," expands on our …
By Peter M. Jaensch & John R. Fleder – The January 21, 2010 Federal Register contains a notice that the United States Sentencing Commission has proposed amendments to the Sentencing Guidelines and their Commentary concerning corporations and other business organizations. In addition, the Commission has raised an issue …
By Peter M. Jaensch – On January 14, 2010, the U.S. Attorney’s Office for the District of Massachusetts issued a statement announcing the charging of Doctor Scott Reuben, a former Chief of Acute Pain at Bay State Hospital in Springfield, Massachusetts, with one count of …
By William T. Koustas & John R. Fleder – A new lawsuit challenges the government’s ability to exclude individuals from participating in federal health care programs after a person has been convicted of a Food, Drug and Cosmetic Act (“FDCA”) misdemeanor. Michael Friedman and Howard R. Udell …
By John R. Fleder – On December 4, 2009, the United States Court of Appeals for the Eleventh Circuit in Atlanta issued a 24-page Opinion in James Hopper v. Solvay Pharmaceuticals, Inc., No. 08-15810. The Court affirmed the District Court’s dismissal of a False Claims Act …
By Ricardo Carvajal – FDA has again posted a warning letter to Procter and Gamble stating that the company’s VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C are unapproved new drugs and are misbranded. The letter states that, when “drug and dietary …
By Jeffrey N. Wasserstein – On October 28, 2009, Michael Loucks, the Acting U.S. Attorney for the District of Massachusetts, announced that his office has recovered over $6.8 billion in healthcare fraud cases over the last 15 years, which is almost 30% of the total healthcare …
By Dara Katcher Levy – On October 21, 2009, First Fishery Development Services filed suit against FDA seeking declaratory judgment and injunctive relief with regard to its product’s placement on Import Alert 99-08 – Detention Without Physical Examination of Processed Foods for Pesticides. According to the …
By JP Ellison – Last year we posed the question “Are the Stars Lining Up for FDA Civil Penalties?” The intervening year has not answered that question, but a recent decision from the Tenth Circuit affirming civil penalties against TMJ Implants, Inc. (“TMJI”) and its founder …
By Ricardo Carvajal – In an unusual step, FDA and FTC have issued a joint warning letter to the internet marketer of a dietary supplement promoted as helpful in preventing swine flu, seasonal flu, and colds. According to the letter, the product “has not been …
By Douglas B. Farquhar – In the second day of the Enforcement and Litigation Conference sponsored by the Food and Drug Law Institute (“FDLI”), speakers from FDA and private industry discussed the trends in international trade in FDA-regulated products, and debated when companies are required …
By Douglas B. Farquhar – At the FDA Enforcement and Litigation Conference sponsored by the Food and Drug Law Institute ("FDLI"), the Compliance Directors of three of FDA's Centers, representatives of other components of the Food and Drug Administration, and a Justice Department official today forecast …
By Jeff Wasserstein – We previously blogged on the effort by W. Scott Harkonen, the former CEO of InterMune, to dismiss an indictment for misbranding and fraud. That effort was unsuccessful, and Mr. Harkonen was convicted after trial of one count of wire fraud. He …
The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Jamie K. Wolszon and John R. Fleder explores the so-called “strict liability” criminal prosecution doctrine in FDA cases that largely derives from the 1975 U.S. Supreme Court case of United States v. Park. FDA believes …
