By John R. Fleder – Although there are many areas where practitioners and others disagree regarding the FDC Act, there is at least one subject that seems to generate universal agreement: FDA has the authority to issue a Form 482 to a companies subject to inspection …
By John R. Fleder – When companies and individuals are “asked” (or told by a court) to pay money to FDA/DOJ as part of a resolution of a civil case, the sting of making the payment can be severe. A question many ask is, “Can we …
By John R. Fleder & Riëtte van Laack – On Friday, January 30, almost nine months after the oral argument, the U.S. Court of Appeals for the D.C. Circuit issued its Opinion in POM Wonderful Inc. v. FTC. We have previously blogged on this case (see …
By John R. Fleder – Lawyers are often asked if a client can be sued if the client does something. Almost without exception, the answer is yes. It does not take much for a person to file a lawsuit in court without much or any evidence, …
By John R. Fleder – The National Advertising Division (“NAD”) of the Council of Better Business Bureaus has administered an industry sponsored, self-regulatory program for many years in which national advertisers can complain about their competitors’ advertising. NAD reviews the advertising and issues public decisions regarding …
By John R. Fleder – In litigation brought by or against FDA, the agency frequently seeks to avoid a “jump-ball” by arguing that FDA’s position is entitled to deference by the court. That argument is consistently made in civil cases and has been made in some …
By John R. Fleder – On October 2, 2013, HP&M posted the following on this blog: On September 26, 2013, the United States Attorney for the District of Colorado announced that he had filed a six count criminal Information against Eric and Ryan Jensen. The government alleges …
By John R. Fleder – On August 8, 2013, we reported on a brief filed by the Department of Justice in United States ex rel. Ge v. Takeda Pharmaceutical Company Limited. The case involves the defendants’ alleged failure to timely report to FDA adverse drug events …
By John R. Fleder – On September 26, 2013, the United States Attorney for the District of Colorado announced that he had filed a six count criminal Information against Eric and Ryan Jensen. The government alleges that the defendants violated the FDC Act by introducing adulterated …
By John R. Fleder – For many years, FDA has taken the public position that nongovernmental entities cannot enforce the Federal Food, Drug, and Cosmetic Act. That position has not deterred lawsuits against businesses under statutes other than the FDCA, arguing that the defendants’ conduct violated …
By John R. Fleder – The Children’s Online Privacy Protection Act (“COPPA”) will celebrate its super, sweet 16 next year. The FTC handles most COPPA enforcement and will no doubt mark the occasion with not-so-super or sweet enforcement. The FTC has issued an amended COPPA rule, …
By John R. Fleder & Riëtte van Laack – On January 16th, the Federal Trade Commission (“FTC”) issued the long-anticipated Decision and Final Order in the FTC’s administrative case filed in 2010 against POM Wonderful LLC, Roll Global LLC, Stewart A. Resnick, Lynda Rae Resnick, and …
By John R. Fleder – We have extensively written about the “Park Doctrine” (see, e.g., here and here) In United States v. Park, 421 U.S. 658 (1975), the Supreme Court authorized the government to criminally prosecute individuals for violations of the FDCA even if a corporate …
By Ricardo Carvajal & John R. Fleder – On November 26th, Commissioner Hamburg issued an order suspending the registration of the Sunland Inc. food manufacturing facility alleged to be at the heart of the ongoing recall of peanut products potentially contaminated with Salmonella. Until the order …
By John R. Fleder – We have previously reported about the Federal Trade Commission’s (“FTC”) case against POM Wonderful, the maker of pomegranate juice (here, here, here, and here). In the world of FTC advertising cases, this litigation is certainly “big league” litigation. On September 27, 2010, the …
