Cal.). On January 16, 2020, the court granted the governments motion to dismiss for lack of subject matter jurisdiction in a challenge to an FDA guidance document concerning the presence of Salmonella in food for animals. On July 20, 2016, a federal jury returned guilty verdicts against William Facteau and Patrick Fabian for distributing a medical device known as the Relieva Stratus Microflow Spacer (Stratus). Earlier this year, Allen pled guilty to one count of a pending indictment charging that she and a co-conspirator in Jamaica sought to unlawfully enrich themselves in a fraudulent lottery scheme targeting an elderly resident of Evans, Georgia. Air was pushed into the clean room through the HEPA filters. The Court granted summary judgment in favor of the government in January. On January 8, 2016, the district court entered a consent decree of permanent injunction against Downing Labs, LLC, Ashley Downing, Christopher Downing, and Roger Mansfield. Sentencing is set for April 6, 2020. FKOL also agreed to implement a compliance and ethics program designed to prevent, detect, and correct violations of U.S. law relating to FKOLs manufacture of cancer drugs intended for terminally ill patients. Both defendants were charged in a 14-count indictment alleging a five-year identity theft scheme that targeted servicemembers and veterans. The court scheduled Armisteads sentencing for December 22. Two Mississippi Men Sentenced in Odometer Fraud SchemeUnited States v. Baine; United States v. Savarese, Press Release Ga.), District Court Rules for Government in Action Against Cheese Manufacturer, Docket Number: 2:14-CV-13077 (E.D. Trial in the case, originally set for May, was continued to September 2020 because of the ongoing public health emergency. Criminal and civil actions were filed against three individuals for marketing and selling dietary supplements as potential disease cures, part of an ongoing efforts to curtail the production and distribution of unlawful dietary supplements. Former Virginia Physician Sentenced for Role in Internet Pharmacy Operation, United States v. Ryan (E.D. On March 23, 2021, Indian drug manufacturer Fresenius Kabi Oncology Limited (FKOL) pleaded guilty and was sentenced by U.S. District Judge Jennifer A. Dorsey to pay a $30 million criminal fine and criminal forfeiture of an additional $20 million. Elmer was convicted of conspiracy and nine counts of adulteration on April 10, 2019, following a jury trial trial. On September 15, 2020, the district court entered a consent decree of permanent injunction against Fortune Food Product, Inc., company president Steven Seeto, and supervisor Tiffany Jiang. Docket Number: 2:14-cr-126 (E.D. Another defendant, Glen Burke, also pleaded guilty in December 2017 and was sentenced on March 12, 2018, to 87 months in prison and three years of supervised release. According to the information, Bencosme and her co-conspiratorsincluding Bencosmes medical practice receptionist, Maytee Lledo, and two UM Research study coordinators, Jessica Palacio and Lisett Raventosfabricated the clinical trial by falsely representing in medical charts and other sources that subjects were participating in the trial when, in fact, they were not participating or taking the study medication as required. The complaint charges that the defendants violated the Telemarketing Sales Rule (TSR) by operating a telemarketing campaign that delivered pre-recorded robocall messages warning consumers about a purported looming 14 percent increase in their energy bill. In a complaint filed June 4, 2018, the United States alleged that inspections at Delta Pharmas facility found numerous insanitary conditions and deviations from current Good Manufacturing Practice requirements, including failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. According to the indictment, the aegeline-containing product was associated with a 2013 outbreak of severe liver injuries before being pulled from the market. Top Regulatory Official at Medical Device Company Sentenced Chicago Dietary Supplement Companies Ordered to Comply with FDCA United States v. Global Marketing Enterprises, Inc., et al.Press Release The court previously entered a default judgment against the entity and two principals located in the United States. On May 9, 2019, the Seventh Circuit Court of Appeals affirmed a civil penalty and injunction imposed by the district court against Spectrum Brands, Inc., a multinational consumer products distributor based in Madison, Wisconsin. On December 4, 2018, the Consumer Protection Branch and the U.S. Attorneys Office for the District of Massachusetts announced an agreement with ev3, Inc., regarding a misdemeanor criminal plea, as well as a criminal fine and forfeiture totaling $17.9 million, to resolve the companys liability for distributing Onyx Liquid Embolic System medical devices that were adulterated under the Food, Drug, and Cosmetic Act. The indictment alleged that the defendants misrepresented the nature and origin of the active ingredients in their products. United States Seeks Temporary Restraining Order Against Fraudulent Online Stores Purporting to Sell COVID-19 Health and Safety Products United States v. Thu Phan Dinh, et al. District Court Enters Consent Decree Against Dietary Supplement ManufacturerUnited States v. Sunset Natural Products Inc., et al. A third individual, Clifford Woods, pled guilty on May 9, 2016, in the U.S. District Court for the Central District of California to a misdemeanor FDCA violation for distribution of unapproved new drugs that he marketed and sold as treatments for cancer and other diseases. FindLaw maintains an archive of Supreme Court opinion summaries from September 2000 to the present. Press ReleasePress Release Lindo is a Jamaican national and naturalized U.S. citizen. Civil Church Law. United States v. Hidalgo et al. The California Courts Meeting Information Center offers online access to Judicial Council of California meetings, presentations, and archived broadcasts. As part of his plea agreement, Romeo admitted the fraud loss caused by the scheme was between $7 million and $20 million. District Court Orders PharMedium Compounding Pharmacy and Two Executives to Comply with Drug Safety Standards United States v. PharMedium Services LLC, et al. Zhang was the sales manager for a Chinese firm that sold raw ingredients for use in dietary supplements. The United States alleged in a complaint filed January 26, 2021, that WeCare Pharmacy, its pharmacist owner Qingping Zhang, pharmacy technician Li Yang, and another related corporate entity, L&Y Holdings LLC, repeatedly dispensed opioids in violation of the Controlled Substances Act. On August 11, 2020, the United States District Court for the Middle District of Florida entered a temporary restraining order pursuant to 18 U.S.C. An FDA inspection performed in March and April 2015 revealed that the companys fish products were adulterated within the meaning of the Food, Drug, and Cosmetic Act in that the company failed to develop and implement an adequate Hazard Analysis Critical Control Point plan to control and prevent identified food safety hazards. Defendant Sentenced in Connection with a Lottery Scam Based in JamaicaUnited States v. Claude Shaw Press Release Two months after B. Braun started selling syringes manufactured at the new AM2PAT facility, B. Braun recalled all of the syringes because the radiation sterilization process caused dangerous white particles to develop in the saline inside the syringes. Fla.). Among other violations of federal law, the defendants made claims about many of their products that rendered the products drugs under the Food, Drug, and Cosmetic Act. The verdict is the latest development in a lawsuit that the Department filed on behalf of the Federal Trade Commission (FTC) in May 2011, seeking, among other things, a permanent injunction and civil penalties against the defendants for engaging in widespread deceptive and abusive telemarketing practices in the course of selling and promoting DVDs and films. Docket Number: 8:18-CV-996 (C.D. Defendants Sentenced in Texas Prescription Drug Smuggling Ring United States v. Catherine Nix,Tom Giddens, and Wanda HollisPress ReleaseDocket Number: 6:14-CR-49 (E.D. Prior to these cases, the Court interpreted the amendment as primarily concerned with protecting African Americans' civil rights. In addition to the companys guilty plea, Roos, and its principals, Ana A. Roos and Virginia Mejia, agreed to a consent decree of permanent injunction. United States v. WeCare Pharmacy, et al. In pleading guilty, Bencosme admitted that she, as principal investigator at Unlimited Medical Research, fabricated the clinical trial by falsely representing in medical charts and other sources that subjects were participating in the trial when, in fact, they were not participating or taking the study medication, as required. Pursuant to the decree, the defendants must cease all operations and obtain FDAs approval before resuming the manufacture of dietary supplements in the future. The complaint alleged that the defendants were not complying with the FDAs current good manufacturing practice regulations and were, accordingly, misbranding the dietary supplements they manufacture and sell. Court Rules in Favor of Government in Challenge to FDA Guidance Document Lystn, LLC, d/b/a Answers Pet Food v. FDA, et al. A hearing for the defendants to show cause why a preliminary injunction should not issue is scheduled for April 24, 2018. Weir is set to be sentenced on May 12, 2017. Docket Number: 4:19-CV-3214 (S.D. Docket Number: 2:19-CR-155 (D. Nev.). Court cases that involve disputes between people or businesses over money or some injury to personal rights are called "civil" cases. Under the Courts order, the defendants may not manufacture or distribute their over-the-counter drug products from any facility owned or operated by the defendants unless they comply with specific remedial measures set forth in the injunction. In addition, S.K. The defendants also sell background reports despite failing to comply with the laws requiring defendants to ensure that the reports are as accurate as possible, to identify who is buying the reports and how they plan to use them, and to notify buyers of how they may legally use the reports. Cal.). As part of the scheme, a victim in Maryland was contacted by an individual in Jamaica and told that she had won a multi-million dollar lottery prize, but that in order to collect her lottery prize, she first had to pay taxes and fees. Docket Number: 4:18-CV-0159 (E.D. As part of their guilty pleas, Hidalgo and Hermoza admitted that they and others they supervised called consumers in the United States falsely claiming to be attorneys and or government representatives. Epsilon further admitted that over the course of nearly a decade, the company knowingly sold 30 million American consumers data to clients engaged in fraud. According to an indictment returned in October 2017, Gao and two co-defendants agreed with a confidential government informant to either mislabel synthetic stimulants such as 1,4-DMAA or otherwise help to hide the true nature of a proposed dietary supplement from retailers. 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