federal civil lawsuit

The indictment alleged that the defendants misrepresented the nature and origin of the active ingredients in their products. On February 22, 2019, Judge David Carter denied defendants motion to dismiss the United States complaint, finding that statements on websites can constitute drug labeling under the Food, Drug, and Cosmetic Act (FDCA). Tex.). The multi-faceted settlement includes a Statement of Facts in which Moodys acknowledged key aspects of its conduct, and a compliance agreement to prevent future violations of law. In addition to the prison term, the court also ordered Crawford to pay $103,700 in restitution. On February 5, 2021, Maytee Lledo pleaded guilty to conspiracy to commit wire fraud in connection with an scheme to falsify clinical trial data. The Code of Virginia of 1950 . The evidence at trial demonstrated that Facteau and Fabian sought to quickly develop and market products, including the Stratus, to create a projected revenue stream that would make Acclarent an attractive business for either an initial public offering or acquisition. In the settlement negotiated by the FTC, Vivint agreed to pay $15 million in civil penalties and $5 million in equitable relief, and to comply with injunctive relief requiring significant affirmative measures to ensure future compliance with the FCRA and to prevent recurrence of its past unlawful conduct. Defendant Pleads Guilty in Multimillion-Dollar Prize-Promotion ScamUnited States v. Lovisa, Press Release On August 5, 2020, a Nevada federal grand jury returned an indictment against Alex Quaglia and Patrick Fraser, both of Canada, for their alleged roles in elder fraud sweepstakes schemes. Docket Number: 1:20-cv-2016 (E.D.N.Y.). 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. In pleading guilty, the defendants admitted that they caused at least 225 vehicles to be sold with rolled back odometers. MD.). Trial began on May 16 and lasted eight days. As part of his plea agreement, Romeo admitted the fraud loss caused by the scheme was between $7 million and $20 million. Docket Number: 2:13-CR-0120 (E.D.N.Y.). Va.). According to the complaint, United States residents received fraudulent direct mail solicitations that falsely claimed that the recipients had won, or would soon win, cash or valuable prizes or otherwise come into great fortune. On March 22, 2017, Cassandra Althea Palmer was sentenced to serve 24 months in prison and three years supervised release in connection with her participation in a Jamaican-based lottery scheme. United States v. Scilabs Nutraceuticals, Inc. and Paul P. Edalat, United States v. New York City Fish, Inc., Maxim Kutsyk, Pavel Roytkov, and Leonid Staroseletesky. Docket Number: 8:20-cv-1794 (M.D. These solicitations, mailed from locations around the globe, purport to be personalized to each individual recipient, despite the fact that they are form letters mailed to hundreds of thousands of potential victims. On February 12, 2016, the district court entered a consent decree of permanent injunction against Mill Stream Corporation of Hancock, Maine, and its owner, Ira J. Victims who paid the fees received either nothing, a cheap piece of jewelry, or a report listing unrelated sweepstakes. Mich.). Acino manufactures hydrocortisone acetate 25 mg suppositories, which it labels and sells as prescription drugs. 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 FDCA. Civil Enforcement Actions Under Controlled Substances Act Announced Against Two Physicians Related to Opioid Distribution United States v. Gregory J. Gerber, M.D., et al. The charges in the indictment stem from Indiviors marketing of Suboxone, an opioid drug used in the treatment of addiction. In pleading guilty, Lledo admitted that while working for a clinical trial company 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. Many of the drugs sold by the defendants were generic drugs that were unapproved for sale in the United States; others were Schedule III steroids or drugs used by steroid users, such as clenbuterol. Hermoza was extradited from Peru last year. The complaint alleges that the companys products are manufactured under conditions that are insanitary and inadequate to ensure the safety of its products. Docket Number: 2:18-CR-0046 (E.D.N.Y.). Under the Federal Food, Drug, and Cosmetic Act, the failure to follow cGMP renders drugs manufactured under such conditions adulterated. Fla.). Fla.). Global consumer goods conglomerate Reckitt Benckiser Group plc (RB Group) has agreed to pay $1.4 billion to resolve its potential criminal and civil liability related to a federal investigation of the marketing of the opioid addiction treatment drug Suboxone. Docket Number: 15-cr-20471 (S.D. );2:16-CR-316 (D.N.J.) One of Robinsons co-conspirators, the title clerk who issued many of the fraudulent titles, was sentenced to five years of probation with 12 months of home detention in September 2016. Enter case number 01-10054 and select Docket Report. Medical Doctor Pleads Guilty in Clinical Trial Fraud Scheme. The complaint alleged that ABH and Islam manufactured and distributed dietary supplements under conditions that failed to comply with current good manufacturing practice regulations. Among other things, Raventos admitted that she falsely represented in medical records that pediatric subjects were participating in the trial when, in fact, they were not participating or taking the study medication. One co-defendant in the scheme was sentenced in March, and a third defendant is set to be sentenced in July. Sitesh Patel, the vice president of S.K. 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. 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. The government presented evidence, collected over nearly a decade, that the defendants violated current good manufacturing practice regulations by, among other things, failing to ensure that finished batches met specifications or to conduct appropriate tests to verify the identity of ingredients. On December 14, 2015, the district court entered a Consent Decree of Permanent Injunction against Bethel Nutritional Consulting and its owners. 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. 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. 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. Violations included having mold covering the ceiling of the walk-in cooler and moving racks of buns from the floor to food production surfaces without sanitizing them. Docket Number: 2:18-CV-06581 (E.D.N.Y.). According to the complaint, lab testing by the U.S. Department of Agriculture detected above-tolerance drug residue in the liver of one of defendants cows sold for slaughter. The Court found that Dish and various retailers the company hired to market its products and services made millions of telemarketing calls to phone numbers on the National Do-Not-Call Registry, calls to persons who asked sellers not to call them, and illegal robocalls. On May 9, 2018, the United States filed complaints against two clinics that purport to manufacture stromal vascular fraction (SVF) products from patient adipose (fat) tissue, which the companies then market as stem cell-based treatments for a host of serious conditions and diseases, including cancer, spinal cord injuries, Parkinsons disease, pulmonary disease, arthritis, stroke, ALS, and multiple sclerosis. The dealers, in turn, sold them to consumers. The indictment, returned on February 23, 2021, alleges that the defendants enrolled subjects into clinical trials who did not meet the eligibility criteria for those trials, falsified laboratory results, falsified medical records, and falsely represented that subjects were taking the drugs being studied when in fact they were not. Jonathan Doyle, the president of USPlabs, and Jacobo Geissler, the CEO of USP Labs, pleaded guilty to conspiracy to introduce misbranded food into interstate commerce. Victims never received any lottery winnings. According to the complaint, a 2016 FDA inspection of the defendants manufacturing facility also revealed that the defendants failed to establish specifications for the identity, purity, strength, and composition of their finished products or the components in their products. Smith also was ordered to pay $167,532.95 in restitution. 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. 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. Long previously operated as a third-party payment processor, creating and depositing checks on behalf of numerous merchants. One of his co-defendants will be sentenced in April, and another co-defendant is set for trial later this spring. Before B. Brauns quality department approved either of AM2PATs changes, B. Braun began selling syringes manufactured in AM2PATs new facility. Va.). Among other provisions, the preliminary injunction bars the defendant from providing or purporting to provide technical-support services and from conducting business through use of any of its email and internet website addresses, including www.computerphoneassist.com, www.elagoonites.com, www.elagoondigital.com, contact@computerphoneassist.com, and contact@elagoonites.com. In a complaint filed February 1, 2019, the United States alleged that the defendants violated the Food, Drug, and Cosmetic Act by causing drugs to become adulterated. Smith was also ordered to pay $724,408.79 in restitution. The defendant also was ordered to make restitution payments to victims. On July 27, 2018, the District Court permanently enjoined three Chicago companiesGlobal Marketing Enterprises, Inc.; Lifeline Nutrients Corp., and Pronto Foods Companyalong with the companies owner, Eduardo Chua, and operations manager, Haidee Dawis, from violating the Federal Food, Drug, and Cosmetic Act. MediNatura recently filed a second motion for preliminary injunction pending appeal, claiming that it was likely to succeed on the merits of the dismissed import alert claims due to changed circumstances. 331(d) and 333(a)(2). The defendants instead took the first six months of payments and more as undisclosed up-front fees. According to the complaint, FDA inspections documented significant deficiencies relating to cleanliness and hygienic practices to protect against food contamination, causing the defendants products to be adulterated under the law. The company makes gels that hospitals and other caregivers use to take ultrasound scans. Complaints for Permanent Injunction Filed Against Two Companies Purporting to Offer Stem Cell Treatments for Serious Diseases United States v. US Stem Cell Clinic, LLC, et al. 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. Docket Number: 1:19-cv-2184 (D.D.C.). In pleading guilty, Burrow admitted that she and her co-conspirators used fraudulent prize notices to mislead victims into believing that they could claim a large cash prize if they paid a fee of $20 to $30. Elmer was convicted of conspiracy and nine counts of adulteration on April 10, 2019, following a jury trial trial. 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. Docket Number: 18-CR-10461 (D. Farris was the sales manager in charge of the telemarketing sales floor. Bobga was charged in June 2020 for his alleged role in a years-long consumer scam. According to the charging document, the amino acid was prepared by Meds IV outside a laminar airflow workbench and was kept unrefrigerated, in a room that was not sterile, in a large pot sitting on the floor, sometimes overnight, before it was sterilized and used. Docket Number: 1:19-CR-00016 (W.D. The coordinated U.S. and Dutch actions immediately stopped defendants from using the Dutch boxes to receive future payments from fraud victims and from further victimizing elderly Americans. The defendants portrayed the companies as law firms and attorney-based companies that would negotiate favorable credit card settlements on behalf of consumers. The charge is not based on printing that search or document. The callers threatened victims with negative credit reports, imprisonment, deportation, or property seizures that could be avoided only through the immediate payment of settlement fees to co-conspirators at the Angeluz Florida Corporation in Miami. Rossi pleaded guilty in December 2017 to conspiracy to commit mail and wire fraud. or https:// means youve safely connected to the .gov website. Defendants Appeal Dismissed in QLaser Medical Device Scam United States v. Robert Larry Lytle et al. Akinyoyenu pleaded guilty on February 27 to a misdemeanor conspiracy count. On February 17, 2021, U.S. District Judge James P. Jones sentenced Brian Parks, the former owner of North Carolina sports supplement company MedFitRX, to 12 months and one day in federal prison. WebThe Federal Rules of Civil Procedure . Lledo is the third defendant to plead guilty in connection with the scheme. Palmer and her friend kept a portion of the money, and Palmer wire transferred the rest to her Jamaican co-conspirator. 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. The plea was part of an global resolution that included a separate consent decree of permanent injunction to resolve civil liability under the FDCA. The injunction requires the defendants to implement certain remedial measures and obtain written approval from the FDA before resuming any manufacture of drugs or dietary supplements. Tex.). Defendants Foreign Properties Sold for $1,665,000 To Obtain Restitution for Fraud VictimsUnited States v. Shevin Goodman On June 8, 2017, Paul Robinson was sentenced to 37 months in prison for his role in an odometer tampering and securities fraud conspiracy. On May 22, 2019, the district court entered a consent decree of permanent injunction requiring a multi-state outsourcing compounding pharmacy and two of its executives to comply with provisions of the Food, Drug, and Cosmetic Act (FDCA) while manufacturing, holding, and distributing drugs. Four Individuals Charged in Connection with Clinical Trial Fraud Scheme. La. On July 23, 2020, Utah resident Gordon H. Pedersen was indicted on wire fraud, mail fraud, and drug misbranding charges in connection with an alleged scheme to fraudulently sell a purported COVID-19 treatment. The defendants made misrepresentations about profits, operating their own vending routes, locations, and ongoing customer support to induce the victims to buy what was advertised as a complete business package, but turned out to be essentially worthless. International Mass-Mailers Enjoined from Further Participation in Fraudulent Solicitation SchemesUnited States v. Alexander Quaglia, et al. Court Denies Homeopathic Drug Companys Third Motion for Injunctive Relief in Case Involving Challenge to FDAs Addition of the Companys Products to an Import Alert. In a prior inspection in December 2011, FDA also found Listeria monocytogenes (L. mono) in the production facilitys environment and on a fish-skinning machine. A company without a food facility registration cannot distribute any food products.

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