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 …
By Douglas B. Farquhar – In a 98-page decision filed on September 23rd, the United States Court of Appeals for the First Circuit affirmed the judgment of Boston federal court Judge Patti Saris awarding certain “Medigap” insurance companies, patients and third-party payors $13 million from …
By Cassandra A. Soltis – Regrow your hair. Cure cancer. Obtain a photographic memory. These are just some of the claims that Kevin Trudeau, infomercial marketer extraordinaire, has made for various products over the years. The Federal Trade Commission (“FTC”) is all-too-familiar with Mr. Trudeau …
By Douglas B. Farquhar – Pharmaceutical manufacturer Pfizer has agreed to the largest drug marketing settlement yet – $2.3 billion (yes, that is “billion” with a “b”) to resolve claims originally brought by six whistleblowers that the firm illegally marketed four drugs – according to …
By JP Ellison & Ricardo Carvajal – A Massachusetts district court has ordered marketers of calcium and herbal supplements touted as effective in preventing, treating, or curing diseases such as cancer, heart disease, and diabetes to pay $70 million in consumer redress. The court’s order dated …
By Susan J. Matthees– The United States District Court for New Jersey recently denied a motion by the Federal Trade Commission (“FTC”) to hold Lane Labs-USA, Inc. (“Lane Labs”), Andrew Lane, and William Lane in contempt for allegedly violating a consent decree. Lane Labs entered into …
By JP Ellison – With the seemingly endless flow of news reports announcing yet another unsealed False Claims Act (“FCA”) case, and the regular announcement of FCA settlements for what would have only a few years ago been unheard of amounts, it is easy to …
By Susan J. Matthees – The Federal Trade Commission (“FTC”) recently announced that an Administration Law Judge (“ALJ”) upheld FTC’s charges against a company, Daniel Chapter One, and its officer, James Feijo, for making claims that its shark cartilage and herbal supplements prevent, treat, and …
By Carmelina G. Allis – The FDA has issued a Federal Register notice announcing a program that establishes a timeframe for the submission and agency review of responses to Form FDA-483s before the agency’s issuance of Warning Letters. This announcement is in line with our …
By Douglas B. Farquhar – In an August 6, 2009 speech at an event sponsored by the Food and Drug Law Institute, Margaret A. Hamburg, M.D., the new FDA Commissioner, promised to ratchet up enforcement by speeding up issuance of Warning Letters, reducing the amount of time that …
By Carmelina G. Allis – We previously reported that Synthes, Inc., Norian Corporation, and four of Synthes’s executives had been charged by the United States government for allegedly violating several provisions of Titles 18 and 21 of the United States Code. The defendants allegedly conducted clinical …
Hyman, Phelps & McNamara’s John R. Fleder has written an article in the July/August 2009 edition of the Food and Drug Law Institute’s Update Magazine. The article is entitled: “Vindicated on Appeal – It Does Happen.” The article discusses a recent ruling in United States …
