Docket Number: 0:17-CV-21659 (S.D. 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. Court Denies Homeopathic Drug Companys Motion for Preliminary Injunction in Case Involving Challenge to FDAs Addition of the Companys Products to Import Alert. On August 29, 2019, U.S. District Judge Roy K. Altman sentenced three residents of Lima, Peru in connection with a fraud and extortion scheme that targeted Spanish-speaking victims in the United States. The Food and Drug Administration cleared LC Bead to be used for embolization, a process in which the flow of blood to liver tumors is stopped or reduced. The government filed a complaint alleging that the companys dietary supplements are manufactured under conditions that are inadequate to ensure the quality of its products. Court Denies Indivior's Motion to Dismiss Indictment Alleging Illegal Opioid Marketing Indiana Resident Charged with Sending Fraudulent Collection Letters to Mail FraudUnited States v. Sherry Gore Court of Appeals Affirms Convictions and Sentences of Co-Conspirators in $60 Million Business Opportunity Scam United States v. Kaplan et al. Press Release Docket Numbers: 1:19-cr-87; 1:19-cr-88 (S.D. 136 No. Medical Device Company Pleads Guilty and is Sentenced to Pay $3 Million for Failure to Report a RecallUnited States v. ACell, Inc.Press Release Press Release In return, victims received worthless costume jewelry. District Judge Stanley R. Chesler told Yabe that you deserve to be professionally disgraced your conduct was unpardonable, but noted that there was no evidence that Yabe intentionally violated the law and credited him for coming to the United States to plead guilty, when there was little possibility that he would be extradited. Defendants in USP Labs Dietary Supplement Scheme Set for Sentencing in July/August 2020United States v. USP Labs, Press Release United States v. Parks/MedFit RX In reality, identical letters were sent to hundreds of thousands of consumers identified through the purchase of lead lists. Dietary Supplement Manufacturer Enjoined from Distributing Adulterated, Misbranded Products Marketed as DrugsUnited States v. EonNutra LLC et al.Press Release 1345 against six individuals and fourteen corporate entities alleged to have operated a mass-mailing scheme based in Las Vegas, Nevada. Docket No. Ohio), Docket Number: 1:15-CR-0024-WLS-TQL (M.D. On June 8, 2018, the district court entered a consent decree of permanent injunction against Delta Pharma, Inc., a Ripley, Mississippi, compounding pharmacy, its owner Dr. Tommy T. Simpson, and its Vice President and Pharmacist in Charge, Charles Michael Harrison, permanently enjoining the defendants from manufacturing and distributing compounded drugs that are adulterated under the Food, Drug, and Cosmetic Act. On June 5, 2017, the U.S. District Court for the Central District of Illinois ordered Dish Network, LLC to pay $280 million in civil penalties and damages to the United States and the states of California, Illinois, North Carolina, and Ohio in connection with more than 100 million illegal telemarketing calls. According to the complaint, FDA inspections revealed Listeria monogytogenes (L. mono) contamination at the facility. United States v. Confidence USA, Inc., et al. Clients made monthly payments expecting the money to go toward settlements. 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. Case No. 1345. On May 11, 2021, a Miami grand jury returned a two-count indictment against Jessica Palacio in connection with Palacios role in an alleged clinical trial fraud scheme. United States v. Vivint Smart Home, Inc., Case No. Injunction Entered Against Eight Individuals and Entities That Ran Psychic Mail Fraud Scheme United States v. Metro Data Management, et al. This makes the method by which laws are developed and enacted. On February 21, 2017, the Court of Appeals for the Eleventh Circuit affirmed the sentence of Sirtaj Tosh Mathauda, who was convicted of conspiracy and multiple counts of mail and wire fraud in connection with a series of fraudulent business opportunities. At the same time, the court sentenced the principals of Quality Egg, Austin Jack DeCoster and Peter DeCoster, each to pay a $100,000 fine and to serve three months in prison followed by a year of supervised release. According to the complaint, consumers pay for items supposedly sold through the websites but never receive those purchases. Internet Pharmacy Operator Sentenced to 25 Years Imprisonment for Wide-Ranging Criminal Enterprise, United States v. Leroux (S.D.N.Y.) In filings unsealed on February 9, 2021, Indian drug manufacturer Fresenius Kabi Oncology Limited (FKOL) agreed to plead guilty to concealing and destroying records prior to a 2013 FDA plant inspection in Kalyani, India. Akinyoyenu admitted that after the doctor approved the website orders from his home in Florida, Akinyoyenu would ship the pharmaceuticals from his brick-and-mortar pharmacy in Washington, D.C. Akinyoyenu admitted that the drugs lacked valid prescriptions, and therefore were misbranded, when shipped. Defendants Sentenced in Connection with Internet Pharmacy SchemeUnited States v. Onochie Aghaegbuna; United States v. Jonathan WallDocket Number: 0:13-CR-273 (D. Minn.). On June 16, 2020, Lawrence B. Ryan was sentenced by U.S. District Judge Robert G. Doumar to 10 months imprisonment for his role in a conspiracy to unlawfully distribute controlled substances and to introduce into interstate commerce misbranded drugs with the intent to defraud or mislead. In addition, the company is paying $25 million to resolve civil allegations under the False Claims Act. United States of America v. City of Seattle. 1345 against three Vietnamese defendants, Thu Phan Dinh, Tran Khan, and Nguyen Duy Toan. As a result of a previous court order, the statements currently are running on television five times per week, and previously ran as full-page ads in about fifty newspapers across the country. 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. The indictment alleges that Mario Castro, Jose Salud Castro, Salvador Castro, Miguel Castro, and Jose Luis Mendez all worked at printing and mailing businesses that sent the fraudulent mailings and shared in the resulting profits. On June 25, 2018, Michael Rossi was sentenced to 63 months in prison plus three years of supervised release in connection with a telemarketing scheme that defrauded thousands of victims, many of whom were elderly, out of more than $2.7 million. Sentencing for Geissler, Doyle, Patel, and S.K. The complaint also alleged that the defendants illegally distributed unapproved new drugs based on labeling claims that certain products treated diseases such as HIV and Alzheimers. Docket Number: 1:20-cr-123 (W.D. 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. Docket Number: 3:15-CV-3769 (D.N.J.). (civil case). The decrees against Hill and Woods were entered on February 26, 2016, and June 27, 2016, respectively. Ltd., Dharti Desai and Mehul Desai. Case Class: On May 20, 2015, the United States filed a criminal Information against ConAgra Grocery Products LLC, a subsidiary of ConAgra Foods Inc., alleging that the company introduced peanut butter contaminated with salmonella into interstate commerce in 2006. Former Virginia Physician Pleads Guilty to Conspiracy to Violate the Controlled Substances Act and Food, Drug, and Cosmetics Act Related to Internet Pharmacy OperationUnited States v. Ryan, Press release Podesta and Polo admitted that they managed and supervised call centers for the scheme. Docket Number: 18-CR-260, 18-CR-261, 18-CR-578 (E.D.N.Y.). See latest for Edward Morris "Ned" Weaver or learn more. Court Enters Order of Permanent Injunction Against California Mung Bean and Soy Manufacturer United States v. Henh Wong Fresh Produce, et al. A preliminary injunction hearing is scheduled for December 3, 2018. On November 5, 2019, Gareth David Long pleaded guilty in the District of Nevada to one count of wire fraud and one count of aggravated identity theft. The complaint alleges that Dr. Tobias Bacaner, Theodore Ferguson II, and Timothy Ferguson used Paragon Community Healthcare Inc., to unlawfully issue controlled substance prescriptions, and Cobalt Pharmacy Inc., to unlawfully fill controlled substance prescriptions, all in violation of the Controlled Substances Act. In pleading guilty, Gutierrez admitted that he oversaw a series of call centers in Peru that threatened Spanish-speaking victims with various consequences if they failed to pay non-existent debts. On April 29, 2021, the Consumer Protection Branch filed a pre-settled complaint referred by the FTC against Utah-based Vivint Smart Home. Cyril Willson, who helped to formulate the companys products, and Mathew Hebert, one of the owners of USP Labs, pleaded guilty to introducing misbranded food into interstate commerce with the intent to defraud or mislead. According to the CDC, several of the Maryland patients reported having eaten soft or semi-soft cheeses in the month before becoming ill. On March 11, 2014, the Food and Drug Administration suspended Roos food facility registration after determining there was a reasonable probability that food manufactured, processed, packed, or held by Roos would cause serious adverse health consequences or death to humans. Justice Department Files Suit Against Tampa-Area Physician, Pharmacy, and Clinic Owners for Opioid-Related Controlled Substances Act Violations. Docket Number: 6:20-cv-140 (E.D. Case law, also known as precedent or common law, is the body of prior judicial decisions that guide judges deciding issues before them. Tex.). According to the complaint, the defendants also misrepresent or fail to disclose material terms of those subscriptions, including that a lump sum will be paid up front, that subscriptions will automatically renew, and that subscriptions can be cancelled only by calling a customer service center that prevents and discourages cancellations or refunds. 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. Docket Number: 1:16-CR-20912 (S.D. Facebook paid the $5 billion penalty on April 29, 2020. On October 6, 2017, Jonathan Wall was sentenced to probation and Onochie Aghaegbuna was sentenced to time served related to their roles in RX Limited, a fraudulent Internet pharmacy scheme. For more information, see the press release dated July 24. District Court Orders PharMedium Compounding Pharmacy and Two Executives to Comply with Drug Safety Standards United States v. PharMedium Services LLC, et al. Docket Number: 1:17-CR-00113 (S.D. The businessman said he borrowed his wife's. As set out in the Departments complaint, which was filed concurrently with the proposed joint Consent Decree on March 10, the defendants manufactured and distributed dietary supplement products as drugs that could help treat or prevent a host of serious conditions, including heart disease, diabetes, depression, hypertension, osteoporosis, and liver and kidney disorders. In pleading guilty, Diaz admitted that he and co-conspirators caused to be mass-mailed to consumers notifications promising large cash prizes in exchange for payment of certain fees. Sentencing before U.S. District Judge Beth Bloom is set for March 19, 2021, in Miami. The consent decree of permanent injunction was entered by U.S. District Court Judge Richard G. Andrews on Jan. 26. The defendants would be required comply with remedial measures to resume any manufacturing, holding, or distribution of drugs. As part of the consent decree, defendants agreed not to resume manufacturing, holding or distributing drugs until they comply with specific remedial measures set forth in the order entered by the Court. On March 31, U.S. District Judge James Jones denied Indiviors motion to dismiss a 28-count indictment alleging the company engaged in healthcare fraud, wire fraud, mail fraud, and conspiracy to commit the same. 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. The defendant sells smart home monitoring products and services on commission using a door-to-door sales force. Fla.). SARMs are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids. Docket Number: 5:17-CR-50022 (D.S.D.). Defendants Appeal Dismissed in QLaser Medical Device Scam United States v. Robert Larry Lytle et al. Tampa Pharmacy and Two Employees Preliminarily Enjoined in Prescription Opioid Enforcement Action. A hearing for entry of a plea and sentencing is scheduled for May 21, 2018. The Court also entered a Consent Order of Forfeiture for $388,265.12, Ul Haqs portion of the proceeds from drug sales to United States customers. United States v. Palacio, Case No. United States v. Confidence USA, Inc., et al., ); 2:14-CV-1156 (D.N.J. Laboratories, a California dietary supplement manufacturer, pleaded guilty to conspiracy to introduce misbranded food into interstate commerce and to the introduction of misbranded food into interstate commerce. United States v. Kimura, Case No. His brother previously pleaded guilty and is awaiting sentencing. On June 6, 2018, the United States filed a civil action seeking to enjoin Innovative BioDefense, Inc., of Lake Forest, California and its CEO, Colette Cozean, from distributing Zylast antiseptic hand sanitizer products that are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. Several inspections of the firms facility between 2012 and 2014 revealed numerous violations of FDAs current good manufacturing practice regulations, including the failure to use equipment and utensils of appropriate design, construction and workmanship to enable them to be adequately cleaned and properly maintained. Civil Case. The callers also falsely threatened victims with court proceedings, negative marks on their credit reports, imprisonment, or immigration consequences if they did not immediately pay for the purportedly delivered products and settlement fees. The court denied plaintiffs two other motions for a preliminary injunction and dismissed MediNaturas claims challenging FDAs addition of its products to the import alert. Simpson case is a case of sexual assault and wrongful death. Three defendants, including Rodis, opened Rodis Law Group and advertised loan modification assistance nationwide. Manufacturer to Pay $43 Million for Distributing Medical Devices with Improper Instructions for Use and Failing to File Timely Adverse Event Reports, United States v. Pentax Medical CompanyPress Release and United States v. Lily Popular Varieties & Gifts, Inc. et al. ); 2:12-CV-2264 (D.N.J. On September 27, 2017, the district court entered a consent decree of permanent injunction against Mary E. Parrish, doing business as Fort Massac Fish Market, a Metropolis, Illinois distributor of caviar and fishery products. Press ReleaseDocket Number: 2:15-CV-1403 (E. D. Bethel sold a wide variety of dietary supplements. Va.). California Man Pleads Guilty to Possession of Child Pornography, United States v. Adrianzen D.C. Pharmacist Who Distributed Drugs Without Valid Prescriptions Ordered to Pay $250,000 Criminal FineUnited States v. Akinyoyenu Press Release Alabama Seafood Soup Producer Signs Consent Decree in Connection with Distribution of Adulterated and Misbranded FoodUnited States v. BEK Catering, LLC d/b/a Floppers Foods, et al. Hermoza was extradited from Peru last year. Chicago Dietary Supplement Companies Ordered to Comply with FDCA United States v. Global Marketing Enterprises, Inc., et al.Press Release Va.). For example, a decision by the US Court of Appeals for the Fifth Circuit is binding on . In affirming the district courts decision, the Court of Appeals held that the statute of limitations for such a violation does not begin to run until a company finally files the required report, and that the Act allows courts to impose forward-looking injunctive relief. 1. Through multiple websites, the defendants promoted the miracle solution as a cure and treatment not only for COVID-19 but also for other serious diseases including Alzheimers, autism, brain cancer, HIV/AIDS, and multiple sclerosis. 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. United States v. All Articles of Other-Sonic Generic Ultrasound Transmission Gel;United States v. Pharmaceutical Innovations, Inc. Press ReleaseDocket Number: 2:14-CV-6139 (D.N.J. On November 19, 2018, the district court entered a temporary restraining order against 15 defendants alleged to have been involved in mailing fraudulent solicitations related to three prize promotion schemes. 2:18-cr-133 (E.D. A noncriminal lawsuit, usually involving private property rights. The CDC did not identify any deaths related to the outbreak. Tex.). Civil law is a type of law that generally deals with disputes between persons or organizations. The court found that the government's actions before the grand jury were neither improper nor misleading, and the court denied Indivior's motion to dismiss the indictment. Another co-conspirator, Omar Portocarrero Caceres, previously was sentenced to 46 months. Sales representatives with the knowledge and encouragement of Vendstars CEO and other managers misrepresented the businesses likely profits, how its past customers were doing, the availability of high-profit locations, and the services that locating companies would provide. District Court Enters Permanent Injunction Against Brooklyn Fish Processor, United States v. Gold Star Smoked Fish Corp., et al. Docket Number: 3:18-CV-01908; 5:18-CV-01891 (N.D. Ohio). Docket Number: 1:16-CV-5264 (E.D.N.Y.). Jury Finds All Defendants Liable in Utah Telemarketing CaseUnited States v. Feature Films for Families, Inc., et al.Docket Number: 2:12-CV-0811 (D. Utah). Docket Number: 1:17-CV-0033-MSK-MJW (D. Colo.). In some instances, a person may be entitled to file a complaint, trusting the legal system to punish the wrongdoer with prosecution, while bringing a civil lawsuit to receive compensation for the damages done by the wrongdoer. The court also observed that even if it had jurisdiction to consider plaintiffs challenge to the FDA guidance document, the plaintiffs request to enjoin FDA from conducting an enforcement action was an impermissible attempt to test a defense pre-enforcement. A .gov website belongs to an official government organization in the United States. The government argued that profits from RX Limiteds drug sales funded Lerouxs other alleged criminal enterprises, including arms trafficking, weapons development for Iran, and cocaine trafficking. United States v. Bacaner, et al., Basnight fraudulently obtained new title documents reflecting the false mileages and resold the vehicles at inflated prices. Press Release From January 2013 through July 2013, Long created and deposited more than 750,000 remotely-created checks, totaling more than $22 million and drawn on the bank accounts of unwitting victims. The complaint alleges that the defendants market their consumer background report service by implying, often falsely, that searched-for individuals have criminal or sexual offense records that can be viewed only by buying a MyLife subscription. Blue Bell Creameries Pleads Guilty in Ice Cream Listeria Contamination Case, United States v. Blue Bell Creameries Shaw also was ordered to pay $128,440 in restitution. A defendant in a criminal case is entitled to an attorney. Blue Bell pleaded guilty to two misdemeanor counts of distributing adulterated ice cream products and has agreed to pay a criminal fine and forfeiture amount totaling $17.25 million according to the terms of a plea agreement. Docket Number: 1:07-CR-20871 (S.D.Fla.). 20-CV-4218 (C.D. Fla.). OxyElite Pro was recalled in 2013 after being linked by the Food and Drug Administration to a deadly outbreak of serious liver injuries. Date Delivered: 14 Apr 2023. Following controversy regarding the safety of DMAA, the defendants reformulated their products to contain a different substance called aegeline. On July 17, 2018, Gao Mei Fang (aka Amy Gao), a Chinese citizen, was sentenced to 12 months and a day of imprisonment on mail fraud and smuggling charges in connection with a scheme to sell mislabeled dietary supplements containing hidden synthetic stimulants. Va.). Lindo received victims money, kept a portion for herself, and sent the remainder to individuals in Jamaica. United States v. Bencosme, et al. where three individual plaintiffs sue one defendant, or one plaintiff sues two separate defendants), attorneys representing each party may give their own distinct opening arguments. 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