Vendstar sales representatives with the knowledge and encouragement of Weaver 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. On May 25, 2016, following eight days of trial, a jury found the defendants committed more than 117 million knowing violations of the TSR, including 99 million calls to phone numbers on the Do Not Call Registry, and more than four million additional calls in which they made misleading statements to induce DVD sales. 401(3), in connection with his role in several fraudulent business opportunities. Three of Palacios co-conspirators already have pleaded guilty and been sentenced, including clinical investigator Dr. Yvelice Villaman Bencosme, who was sentenced to 63 months imprisonment, Lisett Raventos, a study coordinator and co-owner of Unlimited Medical Research, who was sentenced to 30 months imprisonment, and Maytee Lledo, a former employee of Dr. Bencosmes, who was sentenced to 14 months imprisonment. 1343. In denying MediNaturas motion, the court held that the company could not establish a likelihood of success on the merits of those claims without first asking the court to reconsider its dismissal of them. View Upcoming, Past Meetings, and Actions. Docket Number: 2:17-CR-171 (E.D. The indictment further alleged that the defendants imported synthetic ingredients from China using false certificates of analysis and false labeling, and lied about the source and nature of those ingredients to retailers and consumers. Docket NO. Harkonen argued that his conviction should be overturned because his trial team failed to call any expert witnesses for the defense. Robinson pleaded guilty in February 2017 to one count of conspiracy to commit odometer tampering and securities fraud. Civil law is a type of law that generally deals with disputes between persons or organizations. 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. Cantrell initiated voluntary recalls of drug products in 2016 and 2017 due to a lack of sterility assurance. 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. District Court Enters Permanent Injunction Against Chicago Sprout and Soybean Products Company, United States v. Fortune Food Product, Inc. et al. Favorite Pants In 2007, when Custom Cleaners, a neighborhood dry cleaner, returned what Judge Roy Pearson claimed to be the wrong pair of pants, Pearson, an administrative law judge, decided to take action and sue for $67 million. 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: 2:19-CR-155 (D. Nev.). The criminal charges will be dismissed in three years if Pentax complies with enhanced compliance requirements that are part of the agreement. As part of his plea agreement, Basnight admitted that from 2010 until 2016, he purchased more than 50 high-mileage vehicles from individuals and arranged to alter the vehicles odometers to reflect false, lower mileage readings. Two co-conspirators previously were sentenced in connection with this matter. Sentencing before U.S. District Judge Beth Bloom is set for March 19, 2021, in Miami. At times, telemarketers directed homeowners to stop making their mortgage payments. Calif.). Lindo is a Jamaican national and naturalized U.S. citizen. Fla.); 5:16-CV-0577 (M.D. The fine represents Akinyoyenus pecuniary gain from the crime. Tex.). La. According to the complaint, FDA inspections revealed Listeria monogytogenes (L. mono) contamination at the facility. On August 12, 2020, Andrea Burrow pleaded guilty to conspiracy to commit mail fraud based on her participation in a scheme that cheated victims, many of whom were elderly and vulnerable, out of more than $10 million. In addition to two years imprisonment, Judge Judith E. Levy also sentenced Dailey to three years of supervised release. Both men pleaded guilty in March 2016 to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act (FDCA). Docket Number: 19-CV-00027 (C.D. Foo Yuan, which is based in Long Island City, New York, prepares, packs, holds and distributes refrigerated and frozen ready-to-eat fish balls, fried fish cakes and fried fish balls. As part of their guilty pleas, Hidalgo and Hermoza admitted that they and others they supervised called consumers in the United States falsely claiming to be attorneys and or government representatives. 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. Injunction Action Filed Against Drug CompounderUnited States v. Downing Labs, LLC et al.Press ReleaseDocket Number: 3:16-CV-003 (N.D.Tex.). Posing as agents of a fake Fraud Protection Agency, which they claimed was a component of the Federal Trade Commission, the defendants told consumers to send a fee purportedly required by U.S. law in order to receive their prizes. Press Release Systems of common law and civil statutory law differ in many ways. Weir admitted that claims the device could safely and effectively treat virtually any disease were false and intended to mislead consumers. Marks induced sales by misrepresenting the business opportunitys likely profits, the amount of money that prior buyers were earning, how quickly buyers were likely to recover their investment, the quality of locations that were available for the vending machines, and the level of location assistance that buyers would receive from outside locating companies. Simultaneously with the filing of this action, Dutch law enforcement agents executed search warrants on the business address used by both companies and on Dekkers home address. Three men extradited from Peru for overseeing call centers that threatened and defrauded Spanish-speaking consumers in the United States MMS is a mixture of water and sodium chlorite, an industrial chemical used as a pesticide, for fracking and for wastewater treatment. Earlier this year, Allen pled guilty to one count of a pending indictment charging that she and a co-conspirator in Jamaica sought to unlawfully enrich themselves in a fraudulent lottery scheme targeting an elderly resident of Evans, Georgia. Court Rules in Favor of Government in Challenge to FDA Guidance Document Lystn, LLC, d/b/a Answers Pet Food v. FDA, et al. The resolution the largest recovery by the United States in a case concerning an opioid drug includes the forfeiture of proceeds totaling $647 million, civil settlements with the federal government and the states totaling $700 million, and an administrative resolution with the Federal Trade Commission for $50 million. 1. 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 jury acquitted defendants on 14 felony counts of fraud and one conspiracy count. 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. 1345 against Maven Infotech Pvt. On Nov. 14, 2017, the Ninth Circuit Court of Appeals affirmed the conviction of Louis Daniel Smith, who is serving a 51-month sentence for conspiracy, smuggling, distributing misbranded drugs, and defrauding the United States. Palsos guilty plea follows pleas by co-conspirators Larry Smith, Mihir Taneja, Arun Kapoor, Maikel Bolos, and Sterling-Knight Pharmaceuticals in December 2020 and January 2021. The defendants then caused the vehicles odometers and titles to reflect false, low mileages, and they sold the vehicles for inflated prices to unwitting consumers. On November 12, 2014, the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Scilabs Nutraceuticals, Inc., of Irvine, California, and its board chairman and chief executive officer, Paul P. Edalat, to prevent the distribution of adulterated dietary supplements in interstate commerce. Share sensitive information only on official, secure websites. Examples of cases covered under civil law include negligence, fraud, breach of contract, medical malpractice and marriage dissolution. On March 27, 2015, a federal district court entered a consent decree of permanent injunction against L.A. Star Seafood Company, Inc. of Los Angeles, and its corporate officers Sima Goldring and Sam Goldring to prevent the distribution of adulterated seafood products. PharMedium also must take remedial measures to ensure compliance with the FDCA at its other facilities and at its headquarters in Illinois. 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. Cuzcano is the first of five defendants in the case to plead guilty. 1345. According to the complaints, both sets of defendants manufacture their products without FDA approval and without proof of safety and efficacy. 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. The issue of corrective statements to appear at retail locations where cigarettes are sold is being litigated on a separate track before the district court. 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. Guerra was arrested in 2016 by Peruvian authorities and extradited to the United States last year. Defendants Plead Guilty in USP Labs Dietary Supplement Scheme; Sentencings Set for August 2019United States v. USP Labs, Press Release Injunctions Entered Against Defendants in Multi-Million Dollar International Mail Fraud SchemeUnited States v. BDK Mailing GmbH, et al.Press Release Docket Number: 1:17-CV-0236 (S.D. On August 4, 2017, the district court entered a consent decree of permanent injunction against Isomeric Pharmacy Solutions, LLC and company principals William O. Richardson, Rachael S. Cruz and Jeffery D. Brown. Fla.). The consent decree enjoins the defendants from processing or distributing food until they report to the Food and Drug Administration the actions they have taken to bring their operations into compliance with the Food, Drug and Cosmetic Act (FDCA), and FDA notifies them that they appear to be in compliance with specific remedial actions set forth in the decree and the FDCA. 1:21-cr-20301 (S.D. The complaint alleged that the defendants continued to make such claims in violation of the Food, Drug, and Cosmetic Act despite receiving a March 6 joint warning letter from the Food and Drug Administration and the Federal Trade Commission. The government alleged that between 2013 and 2018, the scheme brought in millions of dollars from victims, many of whom were elderly or vulnerable, without paying the promised cash prizes to anyone. 1:20-cr-49 (W.D. The Second Circuit previously affirmed the conviction and sentence of Ned Weaver, the manager of the scheme. Goodman served a prison term of 49 months. 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. According to the indictment, the Peruvian callers represented themselves as attorneys or government representatives and falsely told victims that they had failed to pay for or receive a delivery of products. 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. Sentencing will be held in U.S. District Court in Austin, Texas. On December 5, 2014, Dallal pled guilty to two counts of conspiracy to commit mail and wire fraud. View Complaint. Docket NO. 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. If your court offers it, look at electronic records over the internet. In civil cases in the U.S., the person suing is known as the plaintiff while the person being sued is called the defendant. The complaint further alleges that the pharmacies dispensing of opioids has been tied to the deaths of at least two people, and that numerous other individuals have been treated at hospitals for serious overdoses. My Doctor Suggests is also subject to a civil consent order that requires the company to stop fraudulently labeling its products and to issue full refunds to affected consumers. Despite the fact that the company had told the FDA that the Stratus was intended to maintain an opening to a patients sinus, Facteau and Fabian launched the product intending it to be used as a steroid delivery device. Docket Numbers: 15-cr-20471 (S.D. Sentencing is set for April 6, 2020. District Court Enters Permanent Injunction Against Brooklyn Fish Processor, United States v. Gold Star Smoked Fish Corp., et al. Docket Number: 2:19-CV-9 (M.D. On April 9, 2019, a grand jury returned and indictment against Indivior Inc., a pharmaceutical company, for engaging in an illicit nationwide scheme to increase prescriptions of Suboxone Film, an opioid drug used in the treatment of opioid addiction. Sentencing for USP Labs and SK Labs is set for July 14, 2020. The governments complaint alleged that PharMediums drugs were adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health and because PharMedium failed to comply with current good manufacturing practices. Docket Number:1:18-CV-1102 (E.D.N.Y.). Before closing in July 2010, Vendstar made approximately $10 million to $12 million in sales per year. Ark.). On January 28, 2021, U.S. District Judge Edward R. Korman granted the governments motion for summary judgment in a case seeking a permanent injunction against New York dietary supplement firm Confidence USA and its operators for continued alleged violations of the Food, Drug, and Cosmetic Act. United States v. Eric Nepute and Quickworks LLC, The firm sold their soups to various distributors after receiving seafood from other states including Florida. District Court Enters Permanent Injunction to Stop New Jersey and New York Companies and Executives from Distributing Unapproved and Misbranded DrugsUnited States v. S Hackett Marketing LLC d/b/a Just Enhance, et al. Calif.). 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. The convictions stem from a series of incidents in which multiple patients at hospitals in Europe and the United States experienced serious infections after being treated with a duodenoscope manufactured by Olympus. Palmer and her friend kept a portion of the money, and Palmer wire transferred the rest to her Jamaican co-conspirator. 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. 1345) against Michael Travalino to stop him from marketing herbal remedies as purported treatments for COVID-19 and other serious medical conditions. The settlement includes a $437.5 million federal civil penalty, which is the second largest payment of this type ever made to the federal government by a ratings agency. Argument on the remaining claims in the case, regarding the proper analysis of certain environmental risks, is expected to take place in May. Tex.). Laboratories pleaded guilty on February 25 to introduction of misbranded food into interstate commerce, and USPlabs pleaded guilty to conspiracy to introduce misbranded food into interstate commerce on March 5. Press ReleaseDocket Number: 1:15-CV-23419 (S. D. Fla.). On May 1, 2020, the United States filed a criminal information and plea agreement resolving charges that Texas-based ice cream manufacturer Blue Bell Creameries shipped listeria-contaminated products in 2015. On April 29, 2021, Christopher Reyes pleaded guilty in U.S. District Court for the Northern District of Texas to one count of Conspiracy to Import Drug Paraphernalia, in violation of 21 U.S.C. Altogether, 22 individuals were convicted of fraud in connection with Vendstar. Smith received the money, kept a portion for herself, and sent the remainder to individuals in Jamaica. 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. Several FDA inspections since 2003 have revealed numerous cGMP violations including the defendants failure to maintain equipment used to produce food in a sanitary manner, and to prevent insanitary employee practices. Medical Device Maker ev3 Agrees to Plead Guilty and Pay $17.9 Million for Distributing Adulterated Onyx DeviceUnited States v. ev3, Inc., et al.Press Release The defendants included direct mailers who organized the scheme, mailing list managers, cagers who opened and processed victim returns, and payment processors. The charges allege that the defendants defrauded more than 1 million victims of over $180 million dollars by sending letters purporting to be from world-renowned psychics and promising assistance in achieving wealth and happiness in return for a fee. On October 25, 2018, Patrice Runner, a Canadian and French citizen, was indicted in the Eastern District of New York on charges of mail and wire fraud, conspiracy to commit mail and wire fraud, and conspiracy to commit money laundering. Docket Number: 1:17-CR-0109-MOC-DLH (W.D. (respectively). The complaint also alleged that the defendants distributed unapproved new drugs that they claimed could be used to treat such medical conditions as cancer, heart disease, HIV and AIDS. Docket Number: 2:20-cv-6692 (C.D. Va.). Tex.). The court denied Arbors motion, holding that it could not conclude that Arbor would most likely prevail in the litigation and expressing skepticism regarding Arbors claim of irreparable harm. On August 22, 2018, civil enforcement actions under the Controlled Substances Act were unsealed against two physicians alleging the illegal distribution and dispensing of opioids and other controlled substances. Lledo is the third defendant to plead guilty in connection with the scheme. Mo.). FDA inspections over the past three years have revealed multiple and repeated violations of the Food, Drug, and Cosmetic Act (FDCA) by Downing in the manufacture of compounded sterile injectable drugs. Trial for the remaining defendants is set for July 13, 2021. Wash.). On March 23, 2018, the district court entered a stipulated order permanently enjoining three Utah-based telemarketing companies and their owner from engaging in deceptive and abusive telemarketing practices. The scheme was disrupted before the elderly individual could be further victimized by the conspiracy. Court Denies Drug Companys Motion for Emergency Relief in Case Involving Challenge to FDAs Drug Withdrawal Determination. 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. On February 5, 2021, the court entered a stipulated preliminary injunction that superseded the temporary restraining order and prevents the defendants from dispensing controlled substance prescriptions written by a particular prescriber during the pendency of this case. British Man Pleads Guilty to Wire Fraud and Aggravated Identity Theft for Fraud Scheme with Hundreds of Thousands of VictimsUnited States v. Gareth David Long, Press release 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. The clinical trial sought to compare the efficacy of two asthma treatments in a pediatric population. 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