The letters falsely claimed recipients had won money or valuable prizes, such as luxury cars. Court Dismisses Challenge to FDAs Emergency Use Authorization for Hydroxychloroquine Related to COVID-19 Assn of Am. 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). judgment in a civil action. The consent decree requires Parrish to stop processing and distributing any food and prohibits her from resuming such activity unless she takes steps to ensure the safety of her food and receives FDA authorization to resume production and distribution. Docket Numbers: 1:20-cv-00306-RP (W.D. In pleading guilty, Wall admitted that beginning in 2007, he managed a call center in Manila associated with RX Limiteds online pharmaceutical sales websites. On August 30, 2018, the district court granted the governments motion for default judgment and entered an order of permanent injunction against S Hackett Marketing LLC d/b/a Just Enhance, R Thomas Marketing LLC, Shawn Hackett, and Roger Thomas. Docket Number: 2:16-CV-1643 (C.D. Defendants Sentenced in Connection with Internet Pharmacy SchemeUnited States v. W. Scott HarkonenDocket Number: 15-16844 (9th Cir./N.D. In a complaint filed September 10, 2020, the United States alleged that the defendants violated the Food, Drug, and Cosmetic Act and the Produce Safety Rule by growing sprouts and preparing and holding soy products that FDA inspections showed did not comply with food safety regulations. Docket Number: 1:18-CV-04689-ENV-CLP (E.D.N.Y.). Although Baxter distributed the adulterated products it made in that clean room, there was no evidence of impact on the IV solutions from the mold found on the filters. Lytle and another QLaser distributor, Irina Kossovskaia, were indicted earlier this year on related charges of mail fraud, wire fraud, conspiracy, and contempt. Cadden was convicted of 57 counts following trial, including racketeering, racketeering conspiracy, mail fraud, and violations of the Food, Drug and Cosmetic Act. Such cases are known as civil cases, as opposed to criminal cases, and the legal process is known as civil litigation. The company makes gels that hospitals and other caregivers use to take ultrasound scans. On January 13, 2020, the district court entered a consent decree of permanent injunction against Home Style Foods, Inc., its president, Michael J. Kowalski, and the companys quality manager, Juan Valesquez. Docket NO. A defendant in a criminal case is entitled to an attorney. On Feb. 22, 2018, Thomas Ressler pleaded guilty to one count of conspiracy to commit mail fraud for his role in a large-scale international mail fraud scheme. This litigation arose following eight years of FDA inspections which found that the defendants continually violated the agencys Current Good Manufacturing Practice (CGMP) regulations in their sandwich production. Cal.). On June 2, 2017, Claude Shaw of Miramar, Florida, was sentenced to serve 36 months in prison and three years of supervised release for his participation in a fraudulent lottery scam based in Jamaica. Fla). On October 29, 2019, Fredrick Brown, a former civilian contractor stationed at Yongsan Garrison, a US Army installation in South Korea, pleaded guilty to one count each of conspiracy to commit wire fraud and conspiracy to commit money laundering in connection with the same scheme. Apr 14, 2023, 8:00pm PDT. The injunction, which will last for at least five years, follows an October 20, 2015 order in which the court granted the governments motion for summary judgment, finding that the defendant company, Serra Cheese, was adulterating cheese products under the Food, Drug, and Cosmetic Act. The indictment alleges that PacNet, under the defendants direction, was the payment processor of choice for companies that mailed large volumes of fraudulent notifications designed to mislead victims into falsely believing they would receive a large amount of money, a valuable prize, or specialized psychic services upon payment of a fee. Many homeowners lost their homes to foreclosure after hiring the firms. On March 24, 2020, U.S. District Judge Eric Komitee entered a preliminary injunction under 18 U.S.C. and Medical Devices, Justice for All Act (2004) Victims Notification, DECEPTIVE PRACTICES, TELEMARKETING,and DATA PRIVACY, Marketing Company Agrees to Pay $150 Million for Facilitating Elder Fraud Schemes, United States v. Epsilon Data Management, LLC Court Enters Default Judgment and Permanent Injunction Against Remaining Two Defendants for Selling Miracle Coronavirus Bleach Cure United States v. Genesis II Church of Health and Healing The charge against Gore carries a statutory maximum penalty of 5 years in prison. In pleading guilty, Gali admitted that from 2006 through 2011, he and his brother, Chaim Gali, devised a scheme to defraud consumers by misrepresenting the mileages of used vehicles. Scilabs is a contract manufacturer of dietary supplements distributed under the brand name All Pro Science, including Complete Immune + capsules and various flavored powders called Complete, Recovery and Precharge. (Joel) Frantzman, to prevent the distribution of adulterated seafood products. On March 8, 2021, Michael Palso pleaded guilty to one count of conspiracy to commit health care fraud in connection with a nationwide scheme to defraud pharmacy benefit managers out of $174 million by submitting $931 million in bills for fraudulent prescriptions purchased from a telemarketing company, HealthRight LLC. Arbor claims that it withdrew its drug due to safety concerns raised by FDA, but FDA disagreed, concluding that Arbors drug could still safely be marketed, provided that certain labeling changes were considered to prevent dosing errors. In a complaint filed on May 14, the United States alleged that the defendants, Xephyr LLC (d/b/a N-Ergetics), Brad Brand, Derill Fussell, and Linda Fussell, sold colloidal silver through their website as a treatment for COVID-19 and other diseases and conditions, such as pneumonia, AIDS, and cancer. The conflict started with an Amazon contract. On May 10, 2017, pharmacist Titilayo Akinyoyenu was sentenced to 36 months of probation and ordered to pay a $250,000 criminal fine for his role in a conspiracy to ship pharmaceuticals that were misbranded because they lacked valid prescriptions. The Court sentenced Roos to pay a fine of $100,000. 401(3), in connection with his role in several fraudulent business opportunities. District Court Finds Websites to be Labeling Under FDCA in Denying Motion to Dismiss Enforcement ActionUnited States v. Innovative BioDefense, Inc. et al. On February 17, 2017, Felecia Roxanne Lindo was sentenced to serve 24 months in prison and three years supervised release for her role in a fraudulent lottery scheme based in Jamaica. Rulings in a statutory law system are based primarily statutory laws. The callers also falsely threatened victims with lawsuits, negative marks on their credit reports, imprisonment, or immigration consequences if they did not immediately pay for the purportedly delivered products and settlement fees. In February 2020, Kimura admitted his involvement in a lottery fraud scheme whereby he would receive money orders from lottery fraud victims and money mules, or individuals connected to the scheme who assist in moving proceeds between bank accounts. 19-cr-00632 (N.D. The suit was dismissed for lack of standing because neither the association nor its only identified member established an injury caused by defendants FDA and HHS. In pleading guilty last year, Becker admitted that, from approximately January 2016 to March 2019, he unlawfully distributed Selective Androgen Receptor Modulators (SARMs) and other substances that the FDA has not approved, including ostarine and ligandrol, as part of purported dietary supplements. The injunction prohibits the defendants, who run a non-religious church, from distributing Miracle Mineral Solution, an industrial bleach product the defendants touted as a cure for COVID-19. Court Orders New York Company and its Operators to Stop Distributing Adulterated Dietary Supplements. The Court also imposed strong injunctive relief against Dish to prevent future violations. Blue Bell Creameries Agrees to Plead Guilty and Pay $19.35 Million for Ice Cream Listeria Contamination; Former Company President Charged, United States v. Blue Bell Creameries; United States v. KrusePress release Dr. Bencosme served as the principal investigator for a clinical trial conducted at UM Research intended to investigate the safety and efficacy of an experimental asthma medication in children. The complaint further alleges that the Zylast products are misbranded because of marketing claims stating that FDA considers Zylasts active ingredient safe and effective in open wounds and safe and effective for first aid when FDA has not made such determinations. According to the complaint, victims sent hundreds of millions of dollars to defendants in fees, but received nothing of value in return. In the course of authorizing drug orders for RX Limited, the defendant had no face-to-face contact with customers, performed no mental or physical examinations, did not take patient histories or perform any diagnostic or laboratory testing, did not check the accuracy of the information customers provided, and did not monitor, or provide any means to monitor, medication response. The remaining three defendants are all in custody in the Philippines and awaiting repatriation/extradition. Court Rules in Favor of Government in Challenge to FDAs Authority to Regulate Genetically Modified Salmon IFR v. Azar. United States v. Vivint Smart Home, Inc., Case No. Cal.). In its first court action to combat fraud related to the coronavirus pandemic, the Department obtained a temporary restraining order on March 22, 2020, to block a website purporting to offer to the public World Health Organization COVID-19 vaccine kits. La. On January 27, 2021, U.S. District Judge Raymond P. Moore approved the entry of a deferred prosecution agreement (DPA) between the Department of Justice and Epsilon Data Management, LLC, (Epsilon). Defendant Sentenced in Connection with a Lottery Scam Based in JamaicaUnited States v. Felecia Roxanne Lindo The injunction further requires Dr. Reddys to maintain internal controls and procedures designed to ensure timely, truthful, complete, and accurate reporting of such issues to the Commission. Modified versions of the Soviet legal system operated in many Communist states following the Second World War including Mongolia, the People's Republic of China, the Warsaw Pact countries of eastern Europe, Cuba and . According to the complaint filed in the case, the defendants sent solicitations informing recipients they had won large cash prizes, but that they urgently must pay fees to claim their winnings. Victims were told they had won cars, boats, or other prizes they could claim by purchasing hundreds of dollars worth of vitamins. United States v. Omar Cuzcano Marroquin, et al., Case No. Del.) Press Release This case presents the following issues: (1) Is a grant of Va.). Some solicitations instruct recipients to pay a fee in order to receive their winnings; others urge recipients to purchase goods or services based on false promises that they will guarantee future lottery wins. 1345 against Maven Infotech Pvt. In addition, the company produced fish products under insanitary conditions based on its failure to comply with Current Good Manufacturing Practices. Docket Number: 8:20-cv-1794 (M.D. Docket Number: 15-30332 (9th Cir./E.D. On December 14, 2015, the district court entered a Consent Decree of Permanent Injunction against Bethel Nutritional Consulting and its owners. Defendant Pleads Guilty in Vending Machine Business Opportunity Case United States v. Kevin M. Marks, Docket Number: 2:16-CR-068 (E.D.N.Y.)(SJF). a lawsuit brought by a party (the plaintiff) against another party (the defendant) claiming that the defendant failed to carry out a legal duty owed to the plaintiff and that the defendant's breach of duty caused financial or personal injury to the plaintiff. On June 24, the district court entered a consent decree of permanent injunction against Wa Heng Dou-Fu & Soy Sauce Corporation and the firms co-owners, Peng Xiang Lin and Yuexiao Lin, to prevent the distribution of adulterated and misbranded soy products. Yabe was formerly the top regulatory official at the Japanese company, which also was convicted and in December was ordered to pay $85 million in criminal fines and forfeiture. From January through July of 2013, Long created and deposited more than 750,000 unauthorized checks totaling more than $22 million. Felecia Roxanne Lindo was sentenced in February 2017 to 24 months in prison and three years of supervised release. Individuals, organizations, and businesses involved in lawsuits fall under civil law cases. On August 3, 2020, U.S. District Judge Kathleen M. Williams granted the governments motion for default judgment against two Americans currently located in Colombia who lead the non-religious Genesis II Church of Health and Healing, in an FDCA civil enforcement action. In pleading guilty earlier this year, Zhang admitted that he knew major American dietary supplement retailers would refuse to carry supplements known to contain certain stimulants, such as DMAA. Tex.). On October 21, 2019, the District Court permanently enjoined two additional defendants in connection with three prize promotion schemes that primarily impacted elderly or vulnerable victims. Affected customers interested in refunds can contact My Doctor Suggests LLC at (1-866-660-9868) or refunds@mydoctorsuggests.com. 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. Before it, Gerald Groff had been happy with his work as a rural mail carrier and happy to be able to have Sundays off. The consent decree entered by the court requires the defendants to implement specific remedial measures to comply with the law and obtain written approval from the FDA before distributing such drugs in the future. Specifically, the complaint alleged that multiple FDA inspections revealed that the defendants compounded sterile drugs under insanitary conditions. In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the federal Food, Drug, and Cosmetic Act. Jury Convicts Defendants in Medical Device CaseUnited States v. William Facteau and Patrick FabianPress ReleaseDocket Numbers: 1:15-CR-10076 (D. The verdict was the first ever in an action to enforce the Telemarketing Sales Rule and Do Not Call Registry rule. The court sentenced SK Laboratories, based in Anaheim, California, the following day to two years of probation and $6 million in criminal forfeiture for its role in distributing the supplement. He also pleaded guilty to charges brought by the Narcotics and Dangerous Drugs Section of the Criminal Division related to his sale of methamphetamine precursor chemicals. 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