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 …
Menu
Enforcement
- The Government Taketh and then Giveth BackJune 16th, 2015
- Congress is Taking FDA to Task on its Use and Posting of Untitled LettersJune 1st, 2015
By David C. Gibbons – In a letter sent to Acting FDA Commissioner Ostroff on May 27, 2015, the House Committee on Energy and Commerce (“EC Committee”) informed FDA that it is examining FDA’s “policies and practices regarding the use and publication of untitled letters, including …
- Supreme Court Rejects Plaintiff’s Timeliness Argument in False Claims Acts CaseMay 28th, 2015
By Douglas B. Farquhar – When plaintiffs’ attorneys seek to recover damages because of alleged frauds committed on the federal government – obtaining massive attorneys’ fees and whistleblower bounties for doing so – they frequently argue that no claim is untimely, because of the wars in …
- Quality Egg and Jail Time for a Park Doctrine ProsecutionMay 7th, 2015
By Andrew J. Hull* - On April 14, 2015, a federal judge in Iowa imposed a three-month term of imprisonment on two food executives, describing the period of imprisonment as “relatively small.” After a major Salmonella outbreak in August 2010 that left thousands of people sickened across …
- HP&M-Authored WLF Legal Backgrounder Provides “Warning Letter” to Industry Regarding FDA’s Inspection PracticesMarch 16th, 2015
In a new Legal Backgrounder published by the Washington Legal Foundation, Hyman, Phelps & McNamara, P.C.’s James P. Ellison, Anne K. Walsh, and Andrew J. Hull* write a “Warning Letter” to FDA-regulated drug establishments regarding FDA’s inspection practices. We have written on FDA’s inspection authority …
- FTC Settlement Silences Advertisers of Supplements Advertised as Effective for Children’s Speech Disorders; Settlement Silent on the Number of RCTs RequiredJanuary 14th, 2015
By Riëtte van Laack – According to an FTC Complaint, filed in the United States District Court for the Northern District of Illinois, the advertising practices of NourishLife, an Illinois Company, and its owner, Mark Nottili, (“Defendants”) violated the FTC Act. The FTC alleges that Defendants …
- Main Street Family Pharmacy Compounder Pleads Guilty to Misdemeanor Violations of the FDCA, and Accepts Probation, a $25,000 Fine and a Permanent InjunctionDecember 15th, 2014
By Karla L. Palmer – On December 4, 2014, in the United States District Court for the District of Tennessee, Main Street Family Pharmacy, LLC and its co-owner David Newbaker each pled guilty to a misdemeanor criminal violation of the Federal Food, Drug, & Cosmetic Act …
- DOJ Announces Another GMP Consent Decree for a Dietary Supplement ManufacturerNovember 20th, 2014
By Riëtte van Laack – On Nov. 13, 2014, DOJ announced another Consent Decree of permanent injunction regarding the manufacture and distribution of dietary supplements. Under the Consent Decree, contract manufacturer SciLabs, Inc. and its CEO Paul Edalat are prohibited from the manufacture and distribution of dietary …
- DOJ Files Criminal Case Against Vascular Solutions, Inc. for Off-Label Device PromotionNovember 18th, 2014
By Allyson B. Mullen – Late last week, the Department of Justice ("DOJ") obtained criminal charges from a grand jury sitting in the United States District Court for the Western District of Texas against Vascular Solutions, Inc. ("VSI") and Howard Root, VSI’s CEO, for off-label promotion …
- How Far Does FDA’s Say-So Travel?November 16th, 2014
By Douglas B. Farquhar – For years, one of the frustrations for attorneys challenging FDA in court (including us, many times) has been the degree of deference that federal courts have accorded to FDA interpretations of the Federal Food, Drug, and Cosmetic Act. This happens when …
- CPSC Imposes Largest-Ever Failure to Report Civil Penalty against Baja Inc.November 3rd, 2014
By Alexander J. Varond – In one of the clearest signs that the U.S. Consumer Product Safety Commission ("CPSC") is stepping up enforcement of CPSC requirements, the Commission recently announced that it had reached a record $4.3 million civil penalty settlement with Baja Inc., and its …
- What Can FDA Do During Drug Inspections: Will FDA Apply Its New Guidance to Other Products?October 22nd, 2014
By Jay W. Cormier & Anne K. Walsh – For managers and employees of drug facilities, the arrival of an FDA inspector can be an anxiety-producing experience. Adding to the understandable nervousness surrounding an inspection is FDA’s new statutory authority to deem drug products adulterated if …
- Supreme Court Declines to Hear Omnicare False Claims Act CaseOctober 6th, 2014
By Jennifer M. Thomas – We wanted to briefly update our readers on a case we blogged about in February of this year, United States ex rel. Barry Rostholder v. Omnicare, Inc., 745 F.3d 694 (4th Cir. 2014). To recap, in Omnicare the Fourth Circuit affirmed …
- Bayer Case Highlights the Importance of Involving an Expert in SubstantiationSeptember 28th, 2014
By Jennifer M. Thomas – For the past few days, industry has reacted with anxiety to the government’s decision to pursue an order to show cause why Bayer, Corp. should not be held in contempt of that company’s 2007 consent decree with FTC due to its …
- Former Officials of Peanut Corporation of America Found Guilty; Coincidentally (?), FDA Proposes to Require Supplier Verification Under the FSMA Preventive Controls RuleSeptember 22nd, 2014
By Ricardo Carvajal & JP Ellison – The U.S. Department of Justice recently announced the convictions of former officials and a broker of the Peanut Corporation of America (“PCA”) – the company at the heart an outbreak of salmonellosis five years ago that was traced to the …