The district court entered the proposed consent decree. Ala.). Lledo is the third defendant to plead guilty in connection with the scheme. The case is before U.S. District Judge Robert N. Scola. For Legal Professionals. The order, part of the United States long-running racketeering lawsuit against the cigarette companies, also requires them to attach the same statements to cigarette packages for two weeks at a time, for a total of twelve weeks over two years. In February 2007, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) announced that an ongoing outbreak of salmonellosis cases in the United States could be traced directly to peanut butter produced at the companys plant in Sylvester, Georgia. Following a jury trial in the Southern District of Florida, Mathauda was sentenced to 200 months imprisonment. Docket Number: 6:18-CV-0389 (M.D. 1343. If you believe you are a victim in this matter and would like to speak with someone regarding the case, please call Special Agent Chad Medaris, FDA Office of Criminal Investigations, at 214-887-4174. La. If your court offers it, look at electronic records over the internet. Allen was also ordered to pay $117,000 in restitution. Docket Number: 1:17-CV-0236 (S.D. United States v. Confidence USA, Inc., et al., 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.). One of his co-defendants will be sentenced in April, and another co-defendant is set for trial later this spring. Final proceeds from the sale of these properties will go toward restitution payments in the fraud case. Long pleaded guilty in November 2019 to one count of wire fraud and one count of aggravated identity theft. 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. On Jan. 23, 2018, the 11th Circuit Court of Appeals affirmed the convictions and sentences of three defendants found guilty of fraud and other charges related to the distribution of contaminated peanuts and peanut products by Peanut Corporation of America. As part of the consent decree, the defendants must cease processing and distributing the products at issue unless and until they comply with specific remedial measures set forth in the injunction. District Court Permanently Enjoins 15 Individuals and Companies in Elder Fraud Mail Scheme After these infections, all of B. Brauns syringes manufactured by AM2PAT were recalled. 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. Medical Device Maker Pleads Guilty to Misbranding and Agrees to Pay $36 Million to Resolve Criminal Liability and False Claims Act AllegationsUnited States v. Biocompatibles, Inc.Press ReleaseDocket Number: 1:16-MJ-00710 (D.D.C.). Michigan Defendant Sentenced in Kratom Distribution Scheme United States v. Dailey Press Release Tex.). The civil penalties include $168 million payable to the United States related to at least 66 million illegal calls by Dish and its retailers. In pleading guilty last year, Becker admitted that, from approximately January 2016 to March 2019, he unlawfully distributed Selective Androgen Receptor Modulators (SARMs) and other substances that the FDA has not approved, including ostarine and ligandrol, as part of purported dietary supplements. The insanity conditions included the presence of rodent excrement and mold in the production facility. Business Formation. Some of the defendants products also contained undisclosed active pharmaceutical ingredients. The injunction follows a temporary restraining order entered on allegations that the defendants sent fraudulent notifications to consumers promising large cash prizes pending payment of small fees. She pleaded guilty to one count of conspiracy to commit wire fraud on Sept. 28, 2016. According to the indictment, PacNet served as the middleman between banks and the fraudulent mailers aggregating the checks, cash, and credit card payments collected by its clients, depositing the payments into PacNet-controlled bank accounts, and then distributing the funds as directed by the clients. Dallal procured the drugs from multiple illegal and unlicensed sources and sold them to co-conspirators without the required pedigree document stating where Dallal had purchased the drugs. From 2005 to 2012, the websites operated by Ul Haq and his co-defendant Tahir Saeed illegally sold $2 million worth of prescription drugs, including anabolic steroids and other controlled substances, to customers worldwide, including nearly $780,000 in sales to United States purchasers. Ga.), District Court Rules for Government in Action Against Cheese Manufacturer, Docket Number: 2:14-CV-13077 (E.D. United States v. Becker et al., Cal. A civil lawsuit is filed in a civil court. This is called "remote access Docket Number: 1:18-CV-1121 (E.D.N.Y). According to the governments complaint in the case, the defendants perpetrated a wire fraud scheme by creating websites portrayed as online stores offering products for sale to American consumers, including health and safety related items such as hand sanitizer and disinfecting wipes that have become scarce during the COVID-19 pandemic. On Feb. 20, 2018, the district court issued a temporary restraining order pursuant to 18 U.S.C. Victims were told they must urgently pay fees to collect their winnings. Based on the evidence presented, the court found probable cause to conclude that Defendant Elagoon Business Solutions PVT Ltd., d/b/a Computer Phone Assist was, prior to filing of the Complaint, violating and, unless a preliminary injunction is entered, will continue to violate the federal wire fraud statute, 18 U.S.C. 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. Many alleged victims were elderly or otherwise vulnerable. Docket Number: 1:15-cr-20471 (S.D. The complaint charges that the defendants violated the Telemarketing Sales Rule (TSR) by operating a telemarketing campaign that delivered pre-recorded robocall messages warning consumers about a purported looming 14 percent increase in their energy bill. Docket Number: 3:17-CR-547 (N.D. On June 11, 2019, ACell, Inc., a Maryland-based medical device manufacturer, pleaded guilty to one misdemeanor count of failure and refusal to report a medical device removal to the Food and Drug Administration (FDA). 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 Statement of Facts addresses Moodys representations to investors and the public generally about: (1) its objectivity and independence; (2) its management of conflicts of interest; (3) its compliance with its own stated RMBS and CDO rating methodologies and standards; and (4) the analytic integrity of certain rating methodologies. On August 8, 2018, the District Court permanently enjoined Patrick Fraser, Christopher Fraser, and Ubuki Kanehira, three members of an alleged Canada-based mass-mailing scheme. Docket Number: 3:17-CV-04911 (D.N.J). Rossi pleaded guilty in December 2017 to conspiracy to commit mail and wire fraud. On August 31, 2020, four individuals were charged in connection with a clinical trial fraud scheme in which the conspirators, working through a company called Unlimited Medical Research, allegedly falsified and fabricated the participation of subjects in a pediatric drug study. A third individual, Clifford Woods, pled guilty on May 9, 2016, in the U.S. District Court for the Central District of California to a misdemeanor FDCA violation for distribution of unapproved new drugs that he marketed and sold as treatments for cancer and other diseases. 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 complaints allege that that in some cases, adverse events that harmed patients occurred after treatment with the SVF products, and that recent FDA inspections showed that the defendants products are not manufactured, processed, packed, or held in conformance with current good manufacturing practice (CGMP). In addition to the companys guilty plea, Roos, and its principals, Ana A. Roos and Virginia Mejia, agreed to a consent decree of permanent injunction. The United States criminal trial against Indivior is scheduled to begin on May 11, 2020. Docket Number: 5:12-CR-0141 (N.D. Ga.). Yvelice Villaman Bencosme, M.D., Lisett Raventos, Jessica Palacio, and Maytee Lledo each were charged by information in the Southern District of Florida with one count of conspiracy to commit wire fraud, and Palacio also was charged with one count of making a false statement to the FDA. As part of the scheme, a victim in Maryland was contacted by an individual in Jamaica and told that she had won a multi-million dollar lottery prize, but that in order to collect her lottery prize, she first had to pay taxes and fees. In 2013, Long began to simply charge the bank accounts of consumers whose personal and financial information he had acquired during his time as a payment processor, as well as others whose information he purchased in the form of lead lists. TRO Entered Against Mass-Mailing Fraud Schemes Targeting the Elderly United States v. Trends Service, et al. 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. The government alleged that the companys fish products were adulterated pursuant to the Food, Drug, and Cosmetic Act. The court found that each of the defendants had violated the FDCA in the past, and that the court had scant assurance that defendants would comply with food safety laws going forward. Find a Lawyer. 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. Print. To put it simply, civil law deals with resolving disputes between one entity and another. Docket No. On December 14, 2015, the district court entered a Consent Decree of Permanent Injunction against Bethel Nutritional Consulting and its owners. 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. Injunction Action Filed Against Drug CompounderUnited States v. Downing Labs, LLC et al.Press ReleaseDocket Number: 3:16-CV-003 (N.D.Tex.). On June 29, Ronald Rodis pled guilty to conspiracy to commit mail and wire fraud for his role in Rodis Law Group, a bogus law firm that purported to offer struggling homeowners assistance obtaining loan modifications. and United States v. California Stem Cell Treatment Center, Inc., et al.Press Release 1:20-cr-49 (W.D. Indivior asserted in a motion to dismiss the indictment that the companys alleged encouragement of illegitimate prescribing does not constitute fraud. TRO Shutters Website in First Enforcement Action Against COVID-19 Fraud, United States v. Doe An official website of the United States government. Jonathan Doyle, the president of USPlabs, and Jacobo Geissler, the CEO of USP Labs, pleaded guilty February 21 and February 28, respectively, to conspiracy to introduce misbranded food into interstate commerce. The orders enjoin the defendants from distributing or dispensing any controlled substances defined as opiates and opioids under the Controlled Substances Act (CSA), and from altering, deleting, destroying, mutilating, or transferring any records related to their controlled substance prescriptions or related treatment. Long previously operated as a third-party payment processor, creating and depositing checks on behalf of numerous merchants. LIBEL LAW. Laboratories pleaded guilty to introduction of misbranded food into interstate commerce, and USPlabs pleaded guilty to conspiracy to introduce misbranded food into interstate commerce. Mass.). In pleading guilty, Bencosme admitted that she, as principal investigator at Unlimited Medical Research, fabricated the clinical trial by falsely representing in medical charts and other sources that subjects were participating in the trial when, in fact, they were not participating or taking the study medication, as required. 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. On May 9, 2019, the Seventh Circuit Court of Appeals affirmed a civil penalty and injunction imposed by the district court against Spectrum Brands, Inc., a multinational consumer products distributor based in Madison, Wisconsin. On April 29, 2021, the Consumer Protection Branch filed a pre-settled complaint referred by the FTC against Utah-based Vivint Smart Home. 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. Top Regulatory Official at Medical Device Company Sentenced In granting this motion, Judge Chhabria ruled that FDA has authority under the plain language of the Food, Drug, and Cosmetic Act to regulate the integration of an rDNA construct into a genetically engineered animals genome as a new animal drug. In a complaint filed in May, the United States alleged that inspections at Medistat revealed numerous insanitary conditions, including significant microbial contamination in aseptic processing areas and the failure to use sterile wipes to clean critical surfaces in the pharmacy. 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. On April 21, 2020, the Department of Justice announced that Chipotle Mexican Grill had agreed to pay a $25 million fine to resolve criminal charges related to foodborne illness outbreaks that sickened more than 1,100 people between 2015 and 2018. The callers falsely claimed that victims failed to pay for or receive certain product deliveries, and that victims owed thousands of dollars in fines as a result. United States v. Omar Cuzcano Marroquin, et al., Case No. Three defendants, including Rodis, opened Rodis Law Group and advertised loan modification assistance nationwide. 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. Docket Number: 2:14-CV-6791 (E.D.N.Y.). 4:21-cv-00437-RLW (E.D. As part of his plea agreement, Romeo admitted the fraud loss caused by the scheme was between $7 million and $20 million. Along with pleading guilty, the company agreed to pay a criminal fine of $30 million and forfeit an additional $20 million. Savarese admitted he performed at least 200 of the rollbacks for Baine. Complications from the disease can also lead to miscarriage. Defendant Sentenced in Connection with a Lottery Scam Based in JamaicaUnited States v. Claude Shaw Press Release The three-count complaint alleges that Vivint violated the Fair Credit Reporting Act and Section 5 of the Federal Trade Commission Act by: (1) failing to establish an identity theft prevention program; (2) obtaining consumers credit reports without a permissible purpose; and (3) unfairly selling false debts to debt collectors. Docket Numbers: 1:20-cv-00306-RP (W.D. The Court also ordered Dallal to forfeit $250,000 in ill-gotten gains. Okla.). The U.S. Centers for Disease Control and Prevention (CDC) reported that 64 patients in nine states died. Docket Number: 1:21-cr-00006-RM (D. Colo.). Trial began on May 16 and lasted eight days. Although Baxter distributed the adulterated products it made in that clean room, there was no evidence of impact on the IV solutions from the mold found on the filters. The Dutch authorities also took control of the Dutch postal boxes used by the defendants to receive victim funds. The indictment charges Indivior with mail, wire, and health care fraud conspiracy and substantive counts. In March 2015, the district court granted partial summary judgment in the United States favor on the DNC Registry, oral disclosures, and caller ID claims. Examples of cases covered under civil law include negligence, fraud, breach of contract, medical malpractice and marriage dissolution. On Jan. 25, 2018, Ercan Barka pleaded guilty to one count of conspiracy to commit mail fraud for his role in a large-scale international mail fraud scheme that brought in $50 million from victims between 2011 and 2016. The material was found on Adrianzens cell phone and laptop computer when government agents executed search warrants on both devices in connection with an unrelated fraud investigation. The complaint also alleged that the companies manufactured and/or distributed a number of dermatological products that were not approved by the FDA. The court in both matters granted temporary restraining orders to limit the defendants ability to distribute or dispense controlled substances. The injunction requires L.A. Star and the Goldrings to cease all operations and requires that, in order for the defendants to resume distributing seafood products, the FDA must first determine that its manufacturing practices have come into compliance with the law. The United States will file the consent decree with the court upon assignation of the case. ), Defendant Pleads Guilty in Vending Machine Business Opportunity Case. N.C.). On May 20, 2015, the United States filed a criminal Information against ConAgra Grocery Products, alleging that the company introduced salmonella-contaminated Peter Pan peanut butter into interstate commerce during the outbreak. Depending on the relationship between the deciding court and the precedent, case law may be binding or merely persuasive. and United States v. Lily Popular Varieties & Gifts, Inc. et al. 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