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. Docket Number: 1:17-CR-10288 (D. Docket No. The $36 million global resolution relates to the medical device LC Bead, which is used to treat liver cancer. Docket Number: 1:19-CR-20658-RNS (S.D. On April 29, 2021, Omar Cuzcano Marroquin pleaded guilty to conspiracy to commit mail and wire fraud in connection with a series of Peruvian call centers that used Internet-based calls to contact Spanish-speaking consumers in the United States to threaten and defraud them. La. Victims sent such fees to Shaw, who then forwarded a portion of the money to Jamaica. Prior to the filing of the complaint, Oshiro shuttered his business and agreed to a consent judgment wherein he will be required to obtain FDA approval before re-opening. Court Enters Temporary Restraining Order Against Tech-Support Wire Fraud SchemeUnited States v. Maven Infotech Pvt. Ltd., d/b/a Maven Info Tech Ltd., d/b/a Ozemio Inc., d/b/a OZM, d/b/a Urgent Tech Help, d/b/a UTH In return, victims received worthless costume jewelry. Rodis co-defendants recruited and trained telemarketing staff to answer consumer calls, during which sales staff routinely lied to homeowners about the firms success rates, ability to obtain loan modifications, and, at times, directed homeowners to stop making mortgage payments. 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. Ltd., an India-based company. 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. On May 25, 2018, the district court entered a consent decree of permanent injunction against Michel G. Blanchet, permanently enjoining the defendant from preparing, processing, and distributing fish or fishery products that are adulterated under the Food, Drug, and Cosmetic Act. Docket NO. 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 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. Docket Number: 15-16844 (9th Cir./N.D. A locked padlock Another defendant, Glen Burke, also pleaded guilty in December 2017 and was sentenced on March 12, 2018, to 87 months in prison and three years of supervised release. Each defendant was charged with conspiracy to commit mail and wire fraud and at least one substantive count of mail fraud. Docket Numbers: 1:19-cr-20658 (S.D. The defendants agreed to be bound by a consent decree in which they stated that they no longer manufacturer or process fish or fishery products, and only distribute prepackaged items. The consent decrees require the defendants to stop importing, selling, or distributing toys and other childrens products until they implement product safety and testing programs that will bring their operations into compliance with the law. 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 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. 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. After these infections, all of B. Brauns syringes manufactured by AM2PAT were recalled. In March 2006, B. Braun started buying saline syringes from AM2PAT, Inc. (AM2PAT), despite already being aware of problems related to AM2PAT complying with current good manufacturing practices. Ind.). Medical Doctor Pleads Guilty in Clinical Trial Fraud Scheme. During an inspection in 2015, FDA observed that the firm failed to have adequate HACCP plans to control the hazards posed by several pathogenic bacteria, including Clostridum botulinum, Clostridum perfringens, and Listeria moncytogenes. In a civil lawsuit, Carroll alleges Trump raped her in a Manhattan department store in the 1990s. In pleading guilty, Wall admitted that beginning in 2007, he managed a call center in Manila associated with RX Limiteds online pharmaceutical sales websites. Smith previously pleaded guilty to one count of conspiracy to commit mail and wire fraud. 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. Podesta and Polo admitted that they managed and supervised call centers for the scheme. At the time of their sentencings, both defendants had been incarcerated for approximately 4 years, including time spent in an English jail. Press release FDA inspections and other evidence showed a repeated failure of Serra Cheese to reduce the risk of contamination from bacteria and to undertake critical measures that are essential to prevent the growth of certain potentially dangerous bacteria such as Listeria and E. coli, including failing to adequately clean and sanitize equipment in a proper manner. Docket Number:0:18-CV-60377 (S.D. The complaint alleges that the defendants are in violation of current good manufacturing practice and quality-system requirements, and are marketing medical devices without either clearance or approval. Docket Number: 1:16-CV-2770 (E.D.N.Y.). On April 9, a federal grand jury sitting in Abingdon, Virginia, indicted Indivior for allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone. Additionally, the defendants instructed others to destroy evidence once they became aware that they were under investigation. Docket No. 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. People who eat food contaminated with the Listeria monocytogenes bacterium can contract the disease listeriosis, which can be seriouseven fatalfor vulnerable groups such as newborns and those with impaired immune systems. Between 2012 and 2016, Ressler designed fraudulent sweepstakes and prize notification solicitations sent by co-conspirators to victims in the United States and other countries. Further, because they are prescription drugs, their labels by definition cannot bear adequate directions for use by a layperson. An official website of the United States government. On January 15, 2020, Johnny Hidalgo and Rodolfo Hermoza pleaded guilty to conspiring to commit mail fraud and wire fraud in connection with an extortion scheme involving call centers in Peru. On April 29, 2021, the Consumer Protection Branch filed a pre-settled complaint referred by the FTC against Utah-based Vivint Smart Home. The court also set a June 11 hearing on the governments motion for preliminary injunction. On Jan. 18, 2018, the district court entered a consent decree imposing a $5 million civil penalty and a permanent injunction against Dr. Reddys Laboratories, Inc., a pharmaceutical company, to resolve a complaint that the company violated the Consumer Product Safety Act. WebType: Civil Rights Civil Rights: Other Moore v. Neely Filed: April 26, 2023 as 7:2023cv00536 Petitioner: Kenynia Moore Respondent: Kimberly Neely Cause Of Action: 28 U.S.C. BEK prepared, processed, packed, and distributed ready-to-eat seafood products, namely seafood soups sold under the names Shrimp Locksley and Mamas Gumbo. The FDA had specifically refused Acclarents request to clear the Stratus for marketing as a drug delivery device without further submissions to support that use. The charges in the indictment stem from Indivior's marketing of Suboxone, an opioid drug used in the treatment of addiction. In particular, the court found that because hydroxychloroquine remains an FDA-approved and commercially available drug, physicians are free to prescribe it, and any objections by state medical boards to the use of hydroxychloroquine to treat COVID-19 are not traceable to FDA or HHS. Argument on the remaining claims in the case, regarding the proper analysis of certain environmental risks, is expected to take place in May. mono.) 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. The defendants manufacture a variety of dietary supplements available on their website and in stores, primarily marketed to Chinese-speaking communities. 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. On June 1, 2016, the district court entered a temporary restraining order against an individual and two Dutch companies that allegedly engaged in multiple international mail fraud schemes that have defrauded elderly and vulnerable U.S. victims out of approximately $18 million annually. 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. Docket Number: 2:14-CV-14450 (E.D. In addition to the prison term, the court also ordered Crawford to pay $103,700 in restitution. Blue Bell Creameries Sentencing Date Set in Listeria Contamination Case, United States v. Blue Bell Creameries If you cannot find thecaseparty through thePACER Case Locator, then contact thefederal courtwhere you think the case was filedfor assistance. The injunction, which will last for at least five years, follows an October 20, 2015 order in which the court granted the governments motion for summary judgment, finding that the defendant company, Serra Cheese, was adulterating cheese products under the Food, Drug, and Cosmetic Act. The governments complaint alleges that the pharmacies and pharmacists violated the Controlled Substances Act ("CSA") by filling numerous prescriptions for controlled substances outside the usual course of professional practice and in violation of the pharmacists corresponding responsibility to ensure that prescriptions were written for a legitimate medical purpose. Civil Penalty and Permanent Injunction Entered Against Dr. Reddys Laboratories, Inc. Related to Child-Resistant Drug PackagingUnited States v. Dr. Reddys Laboratories, Inc.Press ReleaseDocket Number: 3:17-CV-13219 (D.N.J.). The suit was dismissed for lack of standing because neither the association nor its only identified member established an injury caused by defendants FDA and HHS. Tex.). The injunction requires the defendants to cease all operations connected to the company, and not to resume operations until FDAdetermines that their manufacturing practices have come into compliance with the law. 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. 1:20-cv-02066 (D.D.C.). During the last five years it was open, Vendstar made approximately $62 million in sales. It depends entirely on the nature of the 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. Docket Number: 2:17-CR-00004 (E.D. or https:// means youve safely connected to the .gov website. The United States alleged in a February 2018 complaint that defendants failed to abide by laws designed to protect consumers from consuming food that contained new animal drugs above legal limits. A jury was selected Tuesday in E. Jean Carrolls rape lawsuit in a New York federal court. 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.). 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. 1:21-cv-810 (N.D. Ga.). Ryan, at the time a licensed physician in Virginia, was paid $2 per drug order. Docket Number: 1:18-CV-04689-ENV-CLP (E.D.N.Y.). The verdict was the first ever in an action to enforce the Telemarketing Sales Rule and Do Not Call Registry rule. Carrolls civil lawsuit was the first of Trumps current legal troubles to make it to trial, with opening Aegerion Pharmaceutical Pleads Guilty for Distributing Misbranded DrugsUnited States v. Aegerion Pharmaceuticals, Inc. A hearing for the defendants to show cause why a preliminary injunction should not issue is scheduled for April 24, 2018. 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. Docket Number: 1:15-cr-20471 (S.D. Sentencing for Geissler, Doyle, Patel, and S.K. Sitesh Patel, the vice president of S.K. Ind.). On March 30, 2018, the district court permanently enjoined a Walton, New York, creamery and its owner, Johannes Vulto, from manufacturing and distributing adulterated food. Robinson owned an auto body shop located in Chesapeake, Virginia. 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. Executives of Canadian Payment Processor Charged with Fraud and Money LaunderingUnited States v. Day, Press Release The agreement resolves pending state court lawsuits in Connecticut, Mississippi, and South Carolina, as well as potential claims by the Justice Department, 18 states, and the District of Columbia. Ark.). 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. ); 2:14-CV-1156 (D.N.J. Both men pleaded guilty in March 2016 to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act (FDCA). The Court held that the defendants violations meant the supplements were adulterated as a matter of law, and set a hearing for February 17 to discuss the scope of a permanent injunction. In February 2012, a Michigan hospital traced infections among 16 surgical patients to a specific gel made by Pharmaceutical Innovations. What is a civil lawsuit? and United States v. Lily Popular Varieties & Gifts, Inc. et al. 18-cr-20506 (S.D. 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. On June 14, 2017, the district court entered a consent decree of permanent injunction against Stratus Pharmaceuticals, Inc., Sonar Products, Inc., and two of the companies executives, Alberto Hoyo and Juan Carlos Billoch. FDA inspectors also found deviations from current good manufacturing practice requirements in the pharmacys sterile drug manufacturing operations. Docket Numbers: 15-cr-20471 (S.D. New Jersey Man Pleads Guilty to Large-Scale International Mass-Mailing Fraud SchemeUnited States v. Ercan Barka On June 24, the district court entered a consent decree of permanent injunction against Wa Heng Dou-Fu & Soy Sauce Corporation and the firms co-owners, Peng Xiang Lin and Yuexiao Lin, to prevent the distribution of adulterated and misbranded soy products. In pleading guilty, Lovisa admitted that he sent prize-promotion mailings that misled recipients, many of whom were elderly, into believing that they could claim and receive large cash prizes in exchange for modest fees. 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. 4:21-cv-00437-RLW (E.D. Bearden, the former compliance director of Pharmakon Pharmaceuticals, Inc. (Pharmakon), of Noblesville, Indiana, pleaded guilty in November 2017 to conspiracy and nine counts of adulterating drugs. Fla). Specifically, the complaint alleged that multiple FDA inspections revealed that the defendants compounded sterile drugs under insanitary conditions. On August 3, 2020, the United States filed a motion for a temporary restraining order pursuant to 18 U.S.C. A copy of the Court Order is available. 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. Romeo has agreed to forfeit more than $1.2 million in profits from his crimes. United States v. Luna, et al. The action is the first brought against a firm for violating safety standards under the Produce Safety Rule enacted under the Food Safety Modernization Act of 2011. District Court Finds Websites to be Labeling Under FDCA in Denying Motion to Dismiss Enforcement ActionUnited States v. Innovative BioDefense, Inc. et al. ), Docket Numbers: 2:16-CR-0124 (E.D. He also hid evidence from FDA inspectors and destroyed evidence while law enforcement agents were executing search warrants on his residence and business locations. Following a 6-week jury trial, each defendant was convicted of 10 counts of introducing adulterated and misbranded medical devices into interstate commerce. Farris was the sales manager in charge of the telemarketing sales floor. The former president says nothing happened between them. 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. 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. Docket Number: 2:18-CR-349 (E.D.N.Y). ); 5:16-CR-0022 (M.D. The complaint against Michael Tricaso, D.O., was filed August 15; the complaint against Gregory Gerber, M.D., which also alleges numerous False Claims Act violations, was filed on August 17. Blue Bell also agreed to pay an additional $2.1 million to resolve civil False Claims Act allegations regarding ice cream products manufactured under insanitary conditions and sold to federal military facilities. The products had not been approved by Food and Drug AdminIstration. District Court Permanently Enjoins 15 Individuals and Companies in Elder Fraud Mail Scheme Smith sold a product called Miracle Mineral Supplement, or MMS, over the Internet. The injunction permanently enjoins the defendants from distributing unapproved, misbranded, and adulterated drugs in violation of the Food, Drug, and Cosmetic Act. On Feb. 13, 2018, Ryan Young 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 indictment alleges that Adrianzen provided payment processing and shipping services for the call centers, knowing that they used fraudulent and extortionate means to extract money from victims. The terms of the permanent injunction and appropriate civil penalty amount will be decided by the court. Mont.). 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. Del.) A lock ( Dec. 1, 2020 . 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). For example in the summer of 2014, inspectors found that 19 lots of Downings drugs had tested positive for various microorganisms, including Staphylococcus haemolyticus, which can cause septicemia, peritonitis, and urinary tract infections, and Nocardia nova, which can cause pneumonia, sinusitis, and skin infections. Docket Number: 2:14-CV-6791 (E.D.N.Y.). The Court rescheduled all sentencing hearings in this matter to July and August 2020.