It includes description of. The permanent injunction prohibits the defendants from distributing Miracle Mineral Solution, an industrial bleach product the defendants touted as a cure for COVID-19 and a plethora of other serious diseases. Docket Number: 0:19-cv-60570 (S.D. B. Braun Medical Inc. Agrees to Resolve Criminal Liability for its Sale of Contaminated SyringesUnited States v. B. Braun Press Release. This is the first enforcement action under the CCPA. Sentencing is set for April 20 in Miami. Pedersens former company, My Doctor Suggests LLC, agreed plead guilty to a one-count misdemeanor criminal information charging distribution of misbranded drugs in violation of the Federal Food, Drug, and Cosmetic Act. 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. Elmer was convicted of conspiracy and nine counts of adulteration on April 10, 2019, following a jury trial trial. The letters falsely claimed recipients had won money or valuable prizes, such as luxury cars. Law & Motion. In addition to pleading guilty to international money laundering and conspiracy charges linked to RX Limited, Leroux also pleaded guilty to trafficking methamphetamine, unlicensed exportation of goods and technology from the United States to a third country, computer hacking, and accessory-after-the-fact charges. Court Permanently Enjoins New York Company from Distributing Adulterated and Misbranded Dietary SupplementsUnited States v. Riddhi USA, Inc., et al.Press Release Through a separate company that it contracted with to market and distribute LC Bead in the United States, Biocompatibles marketed LC Bead to deliver chemotherapy drugs a use that was never cleared or approved by the FDA. Cal. In a third lawsuit, the company sued the FDA in early 2014 for denying it an export certificate attesting that it is in full compliance with the FDCA. Sentencing is set for March 26, 2019. Press Release The FDA has long warned against the use of SARMs, including stating in a publicly available 2017 warning letter that SARMs have been linked to life-threatening reactions including liver toxicity, and have the potential to increase the risk of heart attack and stroke. The U.S. Centers for Disease Control and Prevention (CDC) reported that 64 patients in nine states died. Clients made monthly payments expecting the money to go toward settlements. The court previously entered a default judgment against the entity and two principals located in the United States. The defendants agreed to settle the case and to be bound by a permanent injunction that requires Wa Heng to cease all food preparation, manufacturing and distribution. On February 6, 2019, the district court entered a consent decree of permanent injunction against Raniers Rx Laboratory Inc., d/b/a Raniers Compounding Laboratory, and its owner, Francis H. Ranier. On April 26, 2019, the Eighth Circuit Court of Appeals granted the governments motion to dismiss an appeal brought by a defendant convicted of marketing and selling light-emitting medical devices as a cure-all to (primarily elderly) consumers. According to the information, Dr. Bencosme served as the principal investigator for a clinical trial conducted at Unlimited Medical Research intended to investigate the safety and efficacy of an experimental asthma medication in children between the ages of four and eleven. The settlement includes significant commitments by Moodys to improve its business practices, including: separation of Moodys commercial and credit rating functions; independent review and approval of changes to rating methodologies; changes to ensure that key personnel are not compensated on the basis of the companys financial performance; enhancing Moodys oversight over its press releases and methodology development; and certifications of compliance by the President/CEO of Moodys with these commitments for at least five years. 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. 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. Docket No. Arbor challenged FDAs determination that the original formulation of its drug, Nymalize, was not withdrawn for reasons of safety and effectiveness, which would allow approval of potential generic versions of Arbors withdrawn drug. 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. A preliminary injunction hearing is scheduled for December 3, 2018. Woman Pleads Guilty to Conspiracy to Commit Money Laundering in Connection with International Lottery SchemeUnited States v. Samaiyah ArmisteadPress Release Lead NECC Defendant Sentenced to Nine Years in Prison in Connection with 2012 Nationwide Fungal Meningitis OutbreakUnited States v. Barry CaddenPress Release 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. Ramirez (2021)? );2:16-CV-12655 (E.D. The solicitations misled recipients into believing that they would receive large sums of money or powerful talismans for payments of $50 to $55. The hearings will be held in Dallas before U.S. District Judge Sam A. Lindsay. 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. Ark.). Docket Number: 4:18-CV-0159 (E.D. In pleading guilty, Long admitted that he used personal and financial information of more than 375,000 victims to steal millions of dollars from checking accounts. Isomeric manufactures, labels, and distributes sterile drugs, including injectable hormones, injectable corticosteroids, and ophthalmic drops. The consent decree requires Neptune to cease all manufacturing operations and requires that, in order for defendants to resume distributing seafood products, the FDA first must determine that Neptunes manufacturing practices have come into compliance with the law. The defendants manufactured dietary supplements that they sold through their website and in stores and marketed primarily to Chinese-speaking communities. On August 3, 2015, the district court entered an order of permanent injunction against Henh Wong Fresh Produce, a sole proprietorship, its owner, David C. Ly, and employees Kin S. Ly and Thahn Danny C. Ly, to stop them from violating the Food, Drug, and Cosmetic Act (FDCA) by causing food to be adulterated while it is held for sale after shipment in interstate commerce. Specifically, the complaint alleged that multiple FDA inspections revealed that the defendants compounded sterile drugs under insanitary conditions. The dealers, in turn, sold them to consumers. Weaver argued in his appeal that he was not guilty because Vendstar customers signed purchase agreements in which they disclaimed reliance on what sales representatives had said verbally. Felecia Roxanne Lindo was sentenced in February 2017 to 24 months in prison and three years of supervised release. On September 25, 2015, the district court entered a consent decree of permanent injunction against Sunset Natural Products Inc., and the firms co-owners, Dr. Teresa Martinez (a.k.a Dr. Teresa Martinez-Arroyo) and Elsy Cruz, stopping them from violating the Food, Drug, and Cosmetic Act by manufacturing and distributing adulterated dietary supplements. In granting the governments motion, the court ruled that the FDA guidance document does not constitute final agency action because it provides guidance only and does not create any legal right and because FDA derives no enforcement authority from the [guidance document]. The court additionally compared FDAs public warning to an FDA warning letter, which the Court noted does not constitute final agency action ripe for judicial review. Pentax was charged in a criminal complaint with failing to file timely reports of two hospital infection outbreaks associated with its duodenoscope and with shipping four other types of endoscopes for 18 months without FDA-approved instructions for use. Court Enters Preliminary Injunction Against Tech-Support Wire Fraud SchemeUnited States v. Elagoon Business Solutions Pvt Ltd d/b/a Computer Phone Assist 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. Quaglia and Fraser each were charged with several counts of mail fraud and conspiracy to commit mail fraud in connection with deceptive mass mailings that falsely promised large cash prizes in exchange for the payment of fees. District Court Issues Temporary Restraining Order Blocking Multi-Million Dollar Elder Fraud Schemes United States v. Kafeiti et al. A lock (LockA locked padlock) or https:// means youve safely connected to the .gov website. Olympus pleaded guilty to three misdemeanor counts and Yabe to one misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act by failing to file the required reports with the U.S. Food & Drug Administration. Docket Numbers: 1:19-cr-20658 (S.D. Enforcement Action Filed Against Kansas Food Manufacturer United States v. Native American Enterprises, LLC, William N. McGreevy and Robert C. Conner, Press ReleaseDocket Number: 6:16-CV-1072 (D. Kan.). The indictment charges Palacio with conspiracy to commit wire fraud, in violation of 18 U.S.C. 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. judgment in a civil action. In pleading guilty, Akinyoyenu admitted that he paid a doctor to review thousands of prescription drug orders for a small fee per order. If the defendants seek to resume preparing, manufacturing and distributing food, they must implement remedial measures set forth in the injunction, notify the FDA of the measures taken, and receive written notification from FDA that they appear to be in compliance with the remedial requirements set forth in the injunction and the statute. Smith sold Miracle Mineral Supplement or MMS, which he touted as a cure for cancer, AIDS, malaria, hepatitis, lyme disease, asthma, the common cold, and various other diseases. The scheme was disrupted before the elderly individual could be further victimized by the conspiracy. Many victims made monetary payments based on these threats. In a stipulated order filed with the complaint, Facebook agreed to settle these allegations by paying a $5 billion civil penalty and implementing robust, new compliance measures that will change how Facebook prioritizes and approaches user privacy issues. Docket Number: 2:20-cr-00196 (D. Nev.). The statements address the effects of cigarette smoking and the fact that cigarettes are deliberately designed to create and sustain addiction. In pleading guilty, Lledo admitted that while working for a particular clinical trial site in Miami called Unlimited Medical Research, she helped to fabricate data for a clinical trial designed to test the efficacy of two asthma treatments in a pediatric population by falsely representing that subjects were participating in the trial when, in fact, they were not participating or taking the study medication as required. On August 14, 2020, the district court dismissed a challenge by a physicians interest group to FDAs since-revoked emergency use authorization (EUA) for hydroxychloroquine related to COVID-19. Ga.), District Court Rules for Government in Action Against Cheese Manufacturer, Docket Number: 2:14-CV-13077 (E.D. Shaw also was ordered to pay $128,440 in restitution. Nevada Woman Pleads Guilty in Multi-Million-Dollar Prize Notification Scam Affecting Elderly Victims United States v. Burrow Both the plaintiff and the defendant are also referred to as "parties" or "litigants." A .gov website belongs to an official government organization in the United States. Case No. Victims received telephone calls informing them that they had won more than one million dollars in a lottery, but that they needed to pay advance fees to claim their winnings. Mill Stream Corporation processed and distributed a variety of refrigerated, vacuum-packed, ready-to-eat, cold and hot smoked fish or fishery products such as smoked salmon, trout, and char. Toyota Auto Mart Kenya Limited v Kenyariri (Civil Appeal 008 of 2021) [2023] KEHC 3093 (KLR) (Civ) (14 April 2023) (Judgment) Case Metadata. Find Sports Law Case Summaries at FindLaw. Docket Number: 3:17-CR-546 (N.D. Read online free Civil Church Law Cases ebook anywhere anytime directly on your device. Sentencings for Willson and Hebert are set for August 13 and August 19, 2020, respectively. On May 31, 2017, Rojen Burnett was sentenced to serve 12 months in prison and pay $399,363 in restitution for his role in a conspiracy to sell cars with rolled-back odometers. On May 4, 2017, the district court entered a consent decree of permanent injunction against Syfrett Feed Company, Inc.; the companys owner and president, Charles B. Syfrett I; the companys vice president, Melissa S. Montes De Oca; and its operations manager, Charles B. Syfrett II. The defendants would be required comply with remedial measures to resume any manufacturing, holding, or distribution of drugs. On October 8, 2019, Angel Armando Adrianzen was charged with conspiracy to commit mail fraud and wire fraud, five counts of wire fraud, five counts of mail fraud, and four counts of extortion in connection with an alleged scheme operated by a transnational criminal organization. As part of the permanent injunction, the district court ordered equitable disgorgement with refunds to consumers to be administered by a court-appointed special master. Tex.). On February 7, 2019, U.S. District Judge Aleta Trauger issued a temporary restraining order against two Celina, Tennessee pharmacies, their majority owner, and three pharmacists, stopping them from continuing to dispense controlled substances. The United States will file the consent decree with the court upon assignation of the case. 1345) against Michael Travalino to stop him from marketing herbal remedies as purported treatments for COVID-19 and other serious medical conditions. Press ReleaseDocket Number: 1:16-CV-0348 (S.D. Docket Number: 1:15-cr-20471 (S.D. A civil court is a court of law that handles various types of civil cases. Sitesh Patel, the vice president of S.K. Long did not have authorization to charge any of these victims accounts. Docket Number: 1:16-CR-0021 (S.D. LIBEL LAW. The district court ordered Spectrum to pay $1.9 million in civil penalties, maintain adequate systems and controls to prevent future violations, and retain an outside consultant to evaluate its compliance program. Mich.). On March 15, 2021, U.S. District Judge James P. Jones sentenced Brett Becker to six months of home confinement for introducing unapproved new drugs into interstate commerce in violation of the Food, Drug, and Cosmetic Act. However, according to a criminal Information filed Sept. 22, 2017, Aegerion failed to give health care providers complete and accurate information about HoFH and distributed Juxtapid as a general treatment for high cholesterol without adequate directions for such use. The court previously entered a similar consent decree of permanent injunction on July 12 against Lily Popular Varieties & Gifts, Inc., Great Great Corporation, and their owners and operators Li Jing and Cheng Feng You. Complaint Filed Against California Hand Sanitizer Company Marketing Unapproved New Drugs United States v. Innovative BioDefense, Inc. et al. Indivior Inc. Indicted for Fraudulently Marketing Prescription OpioidUnited States v. Indivior Inc. Press Release The Process On April 23, 2020, Judge Timothy Kelly of the U.S. District Court for the District of Columbia granted the United States' motion to enter a stipulated order against Facebook, Inc. In the underlying lottery fraud scheme, the victim was falsely informed that she had won a lottery but had to pay various up-front fees. On July 25, 2018, Lawson Basnight of Norfolk, Virginia, was sentenced to serve 18 months in prison and three years of supervised release in connection with an odometer and title fraud scheme. The complaint alleges that such drug claims appear on the defendants primary website and the website of one of the companys primary distributors. This scheme defrauded more than 1 million Americans out of more than $180 million. The civil action against the defendants, filed by the United States Attorneys Office for the Northern District of Texas and the Consumer Protection Branch, alleges that the defendants prescribed controlled substances in violation of the CSA. 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 permanent injunction extends a preliminary injunction that halted the scam and shut down two websites used to legitimize the scheme, www.fortune500sweepstakes.com and www.fraudprotectionagency.com. Long used the proceeds of his fraud scheme to purchase a ranch in Texas, three airplanes, cars, buses, ATVs, and a fire truck, as well as to pay other personal expenses. The cases were consolidated for plea and sentencing in Puerto Rico. Usually, the purpose of bringing the case is to get a court order for the . 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. 331(d) and 333(a)(2). 8:21-cv-00188 (M.D. Fla.) The court set a sentencing date of August 3, 2021. 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. The order also imposes a civil penalty of approximately $45.4 million, of which all but $487,735 is conditionally suspended based on the defendants financial condition. 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. 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. A civil case usually begins when one person or business (the "plaintiff") claims to have been harmed by the actions of another person or business (the "defendant") and asks the court for relief by filing a "complaint" and starting a court case. The complaint alleged that FDA inspections of Keystones facilities and products revealed numerous problems, including an instance in which the company released a batch of hair products despite test results suggesting contamination by the potentially harmful bacteria Staphylococcus aureus. And Martha Stewart was sued by her father for insider trading, which resulted in her car catching fire and burning. PCA president Stewart Parnell, sales manager Michael Parnell, and quality assurance director Mary Wilkerson all were convicted in September 2014 and sentenced to 336 months, 240 months, and 60 months of imprisonment, respectively. Docket Number: 2:18-CR-0046 (E.D.N.Y.). Tex.). Tennessee Personal Care Products Manufacturer to Comply with Drug Safety Requirements United States v. Keystone Laboratories, Inc., et al. The civil resolution has been entered in the Western District of Texas, where a whistleblower qui tam complaint had been filed. 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. Judge Chhabria also ruled that FDAs guidance pertaining to genetically engineered animals cannot be challenged because it does not have direct and appreciable legal consequences, and therefore does not constitute final agency action. 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