By John R. Fleder, Douglas B. Farquhar & Peter M. Jaensch – The U.S. Department of Justice announced on November 9, 2010, the government version of a six-count indictment filed in the District of Maryland against Lauren Stevens, a former Vice President and Associate General Counsel for a brand …
In the September/October 2010 edition of the Food and Drug Law Institute’s Update publication, HP&M attorney Jennifer B. Davis authored an article, titled “New Use of Old Tools: Career-Ending OIG Exclusion and FDA Debarment.” The article focuses on the Department of Health and Human Service’s …
By Peter M. Jaensch – Over the last seven months, officials at FDA, including the FDA Commissioner, Margaret Hamburg, MD, and the Deputy Chief Counsel for Litigation, Eric Blumberg, have been promising to resume use of the individual criminal liability doctrine known as the Park Doctrine …
By Jennifer B. Davis – Earlier this week, the Government Accountability Office (“GAO”) publicly released its September 2010 Report to the House Committee on Oversight and Government Reform concerning Drug Safety, titled “DRUG SAFETY – FDA Has Conducted More Foreign Inspections and Begun to Improve Its …
By Peter M. Jaensch & John R. Fleder – A company has “current Good Manufacturing Practice” (“cGMP”) issues. FDA learns about the issues and engages in dialogue with the company regarding the purported violations. No big deal and no news story! Add in a terminated employee who files …
By Douglas B. Farquhar – At a trade industry conference this week, a cadre of government officials unanimously predicted a dramatic increase in the number of criminal prosecutions of individuals for violations of laws governing FDA-regulated industries. They also discussed how the types of prosecutions may …
Hundreds of you have already signed up for Hyman, Phelps & McNamara, P.C.’s free webinar – The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine – scheduled for Friday, October 8, 12:00 p.m. – 1:30 p.m. For those last minute stragglers, …
Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic. You can register for the free webinar here. The webinar will feature attorneys with decades of experience in FDA’s application of …
By Riëtte van Laack – On September 27, 2010, less than two week after POM Wonderful LLC (“POM”) filed a complaint against the Federal Trade Commission (“FTC”) (see our previous post here), the Agency filed a Complaint against POM, its sister corporation Roll International Corp. and …
Hyman, Phelps & McNamara, P.C.’s Douglas Farquhar and Ricardo Carvajal will be presenting at FDLI’s upcoming two-day conference on FDA enforcement and litigation. Mr. Farquhar will moderate a panel on elements of proof in an injunction case, and will present on misdemeanors, debarment, and exclusion. …
Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic. You can register for the free webinar here. (Please register by September 29th.) In criminal prosecutions of corporate executives, ignorance of …
By Kurt R. Karst – The dispute between Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) and FDA over marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL drug products did not end with the July 26, 2010 decision from the U.S. District Court for the District …
By William T. Koustas – Franck’s Lab, Inc. (“Defendant”), an Ocala, Florida veterinary compounding pharmacy, resumed compounding after a federal judge in the United States District Court for the Middle District of Florida denied the Government’s (“Plaintiff”) request for a preliminary injunction on August 19, 2010 that …
By Oisin A. Mulvihill* & Peter M. Jaensch – A recent string of high-profile pharmaceutical and medical device product recalls appears to be reigniting FDA’s interest in pressing misdemeanor charges against corporate executives under the Responsible Corporate Officer Doctrine, or Park Doctrine. Lewis Grossman, professor …
In the July/August 2010 edition of FDLI Update, HP&M attorneys John R. Fleder and Cassandra A. Soltis authored an article, titled “Advertising and Promotion: FDA Is Not the Only Cop on the Beat.” The article focuses on the various non-FDA groups that police alleged false …
