Thoughtful Insight and Updates on Legal Issues that Matter to You

Perspectives

Switzerland’s Oldest Bank, Wegelin & Co., Pleads Guilty to Tax Violations, Agrees to Pay $74 Million to the United States

On January 3, 2013, the United States Attorneys Office for the Southern District of New York announced that Switzerlands oldest bank, Wegelin & Co. (“Wegelin”), has pled guilty “to conspiring with […]

Class Action Lawsuits Attack Yogurt Products for Nonconformance with Standards of Identity

Over the past eight months, numerous class action lawsuits have been filed by consumers against yogurt manufacturers regarding the use of milk protein concentrate (“MPC”) as an ingredient in yogurt […]

FDA Exhibits Increased Authority under Food Safety and Modernization Act

In early September of 2012, the U.S. Food and Drug Administration (“FDA“) and Centers for Disease Control and Prevention (“CDC“) announced an investigation into a multi-state outbreak of Salmonella Bredeney […]

How Can FDA More Reasonably Regulate Autologous Stem Cell Procedures?

In the December 26, 2012 edition of the Food & Drug Law Institutes (FDLI) Policy Forum, Andrew Ittleman of Fuerst Ittleman David & Joseph took on the question of how […]

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs Under FDCA

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical […]

U.S. Lifts Ban on Imports from Burma: Continued Efforts to Ease Burma Back into the Global Economy

Just one day before President Barack Obama embarked on the first-ever trip to Burma by a sitting U.S. president, on November 16, 2012, the U.S. government removed most import restrictions […]

Kirtsaeng v. John Wiley & Sons:

U.S. Supreme Court Addresses the First Sale Doctrines Applicability to Goods Produced and Manufactured Abroad On October 29, 2012, the Supreme Court heard oral arguments in Kritsaeng v. John Wiley […]

Fourth Circuit Court of Appeals Upholds Federal Ban on Trafficking of Certain “Culturally Significant Articles”

On October 22, 2012, the United States Court of Appeals for the 4th Circuit affirmed a Federal District Court decision that a federal ban on the trafficking of certain culturally […]

Proposed Medicare Settlement Clarifies CMS’s Position on “Skilled Maintenance Services”

On October 16, 2012, in the case of Jimmo v. Sebelius, Case No. 5:11-CV-17 (D. Vt. October 16, 2012), a class of Medicare beneficiaries and the United States Department of […]

FDA Issues Draft Guidance and 510(k) Submission Checklist

On August 13, 2012, the U.S. Food and Drug Administration (“FDA“) issued a Draft Guidance document entitled “Refuse to Accept Policy for 510(k)s” (“the Guidance”). The Guidance outlines the procedures […]