growth and toxin formation in susceptible fish and fishery products. In pleading guilty, ACell admitted that in 2012 it determined that more than 30,000 MicroMatrix devices were contaminated with high levels of endotoxin, which posed a risk to patient health ACell also admitted that it initiated a removal of MicroMatrix devices from sales representative inventories, hospitals, and other healthcare centers, but did not notify FDA of the removal or of the endotoxin contamination. Court Denies Homeopathic Drug Companys Motion for Preliminary Injunction in Case Involving Challenge to FDAs Addition of the Companys Products to Import Alert. On April 7, 2020, Pentax Medical Company entered into a deferred prosecution agreement in which it agreed to pay $43 million in criminal fines and forfeiture for violating the Federal Food, Drug, and Cosmetic Act. );1:14-CR-10 (S.D. Defendants in USP Labs Dietary Supplement Scheme Set for Sentencing in July/August 2020United States v. USP Labs, Press Release The website stated that kits would be sent in exchange for a $4.95 shipping charge, which consumers would pay by providing credit card billing information. Long Island Man Pleads Guilty to Mail Fraud Conspiracy. Medical Device Manufacturer Ordered to Pay $85 Million Following Guilty Plea for Failing to File Adverse Event Reports United States v. Olympus Medical Systems Corp. Civil Penalty and Permanent Injunction Entered Against Dr. Reddys Laboratories, Inc. Related to Child-Resistant Drug PackagingUnited States v. Dr. Reddys Laboratories, Inc.Press ReleaseDocket Number: 3:17-CV-13219 (D.N.J.). Author: George James Bayles: Publsiher: Unknown: Total Pages: 240: District Court Issues Temporary Restraining Order against Las Vegas Defendants in Direct-Mailing SchemeUnited States v. Kern, et al. 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. Six defendants were convicted of conspiracy, mail fraud, and wire fraud charges following trial in 2015. 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. Two of the individual defendants, Jacob Geissler and Jonathan Doyle, are expected to be sentenced in federal court in Dallas on October 13 and 15, 2020, respectively. Oshiro has an extensive history of growing, processing, and packaging ready-to-eat mung bean, alfalfa, clover, and radish sprouts under grossly insanitary conditions. Va.). Docket Number: 6:18-CR-0004 (D. Court Permanently Enjoins Texas Ready-to-Eat Fish Processor and Three Individuals from Processing and Distributing Adulterated FoodUnited States v. Topway Enterprises, Inc., et al. ACell manufactures and distributes MicroMatrix, a powder wound dressing produced from porcine bladder tissue. Civil law is a type of law that generally deals with disputes between persons or organizations. See latest for Edward Morris "Ned" Weaver or learn more. United States v. Hidalgo et al. On March 21, 2016, the United States filed an injunction action against Native American Enterprises, LLC (NAE), of Wichita, Kansas, its Vice President and 49% owner, William N. McGreevy, and its Production Manager, Robert C. Conner, to prevent the manufacture and distribution of adulterated food, namely ready-to-eat refried beans and sauces. Long previously operated as a third-party payment processor, creating and depositing checks on behalf of numerous merchants. Permanent Injunction Entered Against Seller of Dietary SupplementsUnited States v. Bethel Nutritional Consulting, Inc., Felix Eamirez, and Kariny Ramirez, Press ReleaseDocket Number: 2:15-CV-8046 (D.N.J.). On February 19, 2021, the United States filed a civil complaint seeking to permanently enjoin the owners of a Tampa-area clinic and pharmacy from unlawfully dispensing opioids and other controlled substances. Docket Numbers: 1:14-cr-75 & 1:12-cr-489. According to the complaints, both sets of defendants manufacture their products without FDA approval and without proof of safety and efficacy. Smith instructed customers to combine MMS with citric acid and ingest the resulting chlorine dioxide. Between 2012 and 2016, Ressler designed fraudulent sweepstakes and prize notification solicitations sent by co-conspirators to victims in the United States and other countries. Docket No. As alleged in the governments complaint, the defendants called and sent letters to consumers falsely claiming that the consumers had won hundreds of thousands of dollars in a sweepstakes. 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. On July 9, 2020, U.S. District Judge Orlando L. Garcia sentenced Trorice Crawford to 46 months imprisonment for his role in an identity theft and fraud scheme that targeted U.S. servicemembers and veterans. Defendants in a civil case don't have the right to an . Trial for the remaining defendants is set for July 13, 2021. On August 20, 2018, the United States filed a civil complaint for permanent injunction against Foo Yuan Food Products Company, Inc., its owner and president Hsing Chang, and its secretary Susan Chang. Allen's co-conspirator falsely informed the victim by phone that the victim had won money in a lottery, and instructed the victim to make payments to various people in order to collect the purported lottery winnings. Docket Number: 8:20-cv-1794 (M.D. Docket Number: 1:20-cv-2016 (E.D.N.Y.). Fla.);2:16-CR-0191 (C.D. Docket Number: 4:18-CV-0159 (E.D. The permanent injunction entered by the court enjoins the defendants from making various claims in any advertisements, solicitations, or promotional materials sent through the mail, including a ban on any advertisements on behalf of any actual or fictional individual or entity purporting to offer psychic, clairvoyant or astrological items or services for a fee. Docket Number: 1:07-CR-20871 (S.D.Fla.). ACell further admitted that it did not notify doctors who already had purchased or used contaminated MicroMatrix about the removal. Sitesh Patel, the vice president of S.K. The complaint further alleges that the defendants issued numerous purported prescriptions without a legitimate medical purpose and outside the usual course of professional practice to undercover agents of the United States Drug Enforcement Administration. According to the complaint, victims who received these solicitations sent payments through the U.S. and international mail systems to defendants Trends Service in Kommunikatie, B.V. (Trends), and Kommunikatie Service Buitenland, B.V. (KSB), both owned and operated by defendant Erik Dekker. Blue Bell Creameries Sentencing Date Set in Listeria Contamination Case, United States v. Blue Bell Creameries Both men pleaded guilty in July 2019 to conspiracy to alter odometers. Defendants products, which included 4NOx2, HGH Night Time, rHGH Drops Black Label, Primal Rage Levo 5 GH Mass and Deer Antler Velvet Extract, were not approved by the FDA. Five other defendants Mario Castro, Jose Salud Castro, Salvador Castro, Miguel Castro, and Jose Luis Mendez are awaiting trial, which likely will be scheduled for May 2021. 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. On December 10, 2014, the United States filed a civil action against William H. Oshiro d/b/a RZM Food Factory to enjoin him from violating the Federal Food, Drug and Cosmetic Act, including violations of current Good Manufacturing Practice standards. 371, and criminal contempt in violation of 18 U.S.C. Docket Number: 2:20-cr-00188 (C.D. Sonar, a New Jersey corporation, manufactures drugs for Stratus. International Mass-Mailers Enjoined from Further Participation in Fraudulent Solicitation SchemesUnited States v. Alexander Quaglia, et al. 1345 against two businesses and two individuals alleged to operate a direct-mailing scheme based in Fort Lauderdale, Florida. Docket Number: 2:17-CV-0852 (D. Utah). Mass.). District Court Enters Permanent Injunctions Against Two New York Companies Banning the Importation of Dangerous ToysUnited States v. Everbright Trading, Inc. et al. One of his co-defendants will be sentenced in April, and another co-defendant is set for trial later this spring. Hermoza was extradited from Peru last year. Courts handle two types of disputes: civil and criminal. 1345 against three Vietnamese defendants, Thu Phan Dinh, Tran Khan, and Nguyen Duy Toan. New Jersey Dietary Supplement Executive Pleads Guilty to Fraud, FDCA Charges UnitedStates v. David Romeo, Press ReleaseDocket Number: 2:16-CR-092 (D.N.J.). Two Defendants Plead Guilty to Identity Theft Scheme Targeting Servicemembers and VeteransUnited States v. Crawford, United States v. BrownPress Release - BrownPress Release - CrawfordDocket No. On December 21, 2022, the U.S Attorney's Office for the Eastern District of Michigan executed a settlement agreement with Julie B. Griffiths Law Office, a small law family practice in Flint, Michigan, under Title III of the ADA regarding failing to provide appropriate auxiliary aids and services to ensure effective communication for an individual who is deaf and uses American Sign Language. On December 7, 2016, Palmer pleaded guilty to one count of conspiracy to commit mail and wire fraud. From 2006 to 2010, Akinyoyenu owned and operated an internet pharmacy called Apex Online Pharmacy. To put it simply, civil law deals with resolving disputes between one entity and another. Barka, who primarily resided in Turkey during the course of the scheme, worked with a co-conspirator to send fraudulent prize notification letters to victims in the United States and numerous other countries. The clinical trial sought to compare the efficacy of two asthma treatments in a pediatric population. SHARE The Supreme Court, the Sabbath and a much-debated piece of civil rights law. Court Enters Injunction Against California Producer of Adulterated and Misbranded Soy ProductsUnited States v. Wa Heng Dou-Fu & Soy Sauce Corporation, Peng Xiang Lin and Yuexiao LinPress ReleaseDocket Number: 2:16-CV-1358 (E.D. The Right to an Attorney. In a complaint filed in January, the government alleged that the defendants knowingly conveyed hundreds of millions of fraudulent robocalls from foreign entities to American consumers. The government alleged in its complaint that Travalino sold various preparations through his storefront and a website as guaranteed cures and treatments even after receiving a joint warning letter from FDA and FTC advising him that the distribution of his products violated the Federal Food, Drug, and Cosmetic Act and Federal Trade Commission Act. Ressler also agreed to a civil consent order, filed Feb. 21 with in the Eastern District of New York, that enjoins him from involvement in further fraudulent solicitation schemes. Fourth Circuit Declines to Apply Federal Common Law for Municipal Climate Change Lawsuit. Thousands of vulnerable victims paid the conspirators money because of these threats, which caused more than $1 million in losses to victims in the United States. Turner also admitted that after her first fraudulent pharmacy was closed for drug diversion, she started an identical drug diversion scheme in a neighboring state. The permanent injunction requires Scilabs and Edalat to cease all operations connected to the company, and not to resume until FDA determines that their manufacturing practices have come into compliance with the law. Eliza Anderson, Deseret News. On May 22, 2019, Hisao Yabe was sentenced to one year of probation and fined $5,000 for his failure to report to the Food and Drug Administration information that called into question the safety of a medical device manufactured by Olympus Medical Systems Corporation. 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