By John R. Fleder – On July 27, 2012, the United States Court of Appeals for the D.C. Circuit issued its long-awaited ruling in Friedman v. Sebelius, No. 11-5028. The case involves a challenge to a decision by the Secretary of Health and Human Services (“HHS”) …
By Benjamin K. Wolf* & John R. Fleder – Dr. Glen R. Justice, a 67 year old oncologist and hematologist, pleaded guilty to defrauding government, public and private insurers out of at least $400,000. The government alleged that Dr. Justice billed for treatments either not given …
By John R. Fleder – It is often said that a grand jury would indict a ham sandwich if asked to do so by a prosecutor. Some lawyers also say that the government cannot lose an FDA misdemeanor prosecution against current and former company officials because …
By Jennifer M. Thomas & John R. Fleder – Last week, the Federal Trade Commission (“FTC”) announced a $40 million settlement with Skechers USA, Inc. (“Skechers” or “the Company”) to resolve charges that the Company made deceptive and unfounded claims that its Shape-up sneakers would help …
By John R. Fleder & Jennifer M.Thomas— As previously reported here, on April 13, 2012 ViroPharma Incorporated (“ViroPharma” sued FDA to challenge the agency’s April 9, 2012 approval of three Abbreviated New Drug Applications (“ANDAs”) for generic versions of the company’s antibiotic drug Vancocin® (vancomycin hydrochloride). …
By Riëtte van Laack & John R. Fleder – After the Federal Trade Commission (“FTC”) entered consent orders against Nestle and Iovate (see here), prohibiting future claims for respondents’ food and dietary supplements unless they are supported by two well-controlled clinical studies, the industry has been …
By Wiliam T. Koustas & John R. Fleder – We recently reported on FDA’s attempt to assert its authority over intrastate commerce through a novel interpretation of “interstate commerce” under the Federal Food, Drug, and Cosmetic Act (“FDCA”). Regenerative Sciences, Inc. (“Regenerative”) is challenging FDA’s claim …
By John R. Fleder – It is no secret that the government has devoted considerable resources in recent years seeking to combat what it has contended is wide-spread illegal off-label marketing and promotion of devices and drugs. Many people believe that the government has created this …
By Wes Siegner, John R. Fleder & Ricardo Carvajal – In U.S. v. Scenic View Dairy, LLC, et. al., the government prevailed on summary judgment in an injunction action against dairy farms alleged to market cows bearing unlawful drug residues. Although nominally a veterinary drug case, …
By William T. Koustas & John R. Fleder – Google, Inc. (“Google”) and the Department of Justice (“DOJ”) (acting in concert with FDA’s Office of Criminal Investigations) have settled the government’s criminal investigation into Google’s AdWords program, which displayed advertisements on websites for online Canadian pharmacies. …
By Anne K. Walsh & John R. Fleder – Companies must proactively prepare for the strong arm tactics the government employs to investigate companies regulated by FDA. A recent case demonstrates that the federal government can act with little regard to companies seeking to represent themselves by …
By John R. Fleder – For over forty years there has been a unit in the Department of Justice dedicated to representing FDA in court actions. Originally housed in the Antitrust Division under the name “Consumer Affairs Section”, the office was moved to DOJ’s Civil Division …
By John R. Fleder – In a stunning ruling on May 10, 2011, United States District Court Judge Roger W. Titus ruled from the bench in Greenbelt, Maryland, granting a Motion for a Judgment of Acquittal filed by the defendant, Lauren Stevens. Ms. Stevens was formerly …
By John R. Fleder – In 2004, the Federal Trade Commission (“FTC”) brought a civil action against the marketers of products sold as “Coral Calcium Daily” and “Supreme Greens with MSM.” The FTC challenged a number of claims, including that the products allegedly made express or …
By Peter M. Jaensch & John R. Fleder – On January 18, 2011, the President issued a significant Order entitled a “Memorandum for the Heads of Executive Departments and Agencies.” The Memorandum directs “agencies with broad regulatory compliance and administrative enforcement responsibilities” to, within 120 days, …
