An FDA inspection performed in March and April 2015 revealed that the companys fish products were adulterated within the meaning of the Food, Drug, and Cosmetic Act in that the company failed to develop and implement an adequate Hazard Analysis Critical Control Point plan to control and prevent identified food safety hazards. District Court Adopts Consent Order on Implementation Details for Tobacco Corrective StatementUnited States v. Philip Morris USA, Inc., et al.Press ReleaseDocket Number: 1:99-CV-2496 (D.D.C.). Bethel sold a wide variety of dietary supplements. Docket Number: 1:18-CV-22016 (S.D. Ltd., which also does business as Maven Info Tech Ltd., Ozemio Inc., OZM, Urgent Tech Help, and UTH, is violating, or is about to violate the federal wire fraud statute, 18 U.S.C. Trial for the remaining defendants is scheduled to begin June 13, 2017. ), Docket Numbers: 2:16-CR-0124 (E.D. The courts order permanently enjoins the defendants from violating the Food, Drug, and Cosmetic Act and requires Gold Star and Pincow to implement consumer safety measures before continuing to process, pack, or distribute any fish or fishery products. According to the complaint, consumers pay for items supposedly sold through the websites but never receive those purchases. 19-cv-03073 (E.D.N.Y.). Tex.). On April 29, 2019, Caprice R. Bearden was sentenced in Indianapolis for her role in a conspiracy to defraud the U.S. Food and Drug Administration concerning the distribution of under- and over-potent compounded drugs. 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. The indictment alleges that Adrianzen partnered with several Peruvian call centers that contacted Spanish-speaking consumers in the U.S., many of whom were elderly and vulnerable. An indictment is merely an allegation. 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. Canadian Men Charged in Alleged Mass-Mailing Elder Fraud Schemes United States v. Quaglia et al. Lledo is the third defendant to plead guilty in connection with the scheme. The letters falsely claimed recipients had won money or valuable prizes, such as luxury cars. Sentencings for Willson and Hebert are set for August 13 and August 19, 2020, respectively. Mass.). Fast Download speed and no annoying ads. Mich.). Michigan Defendant Sentenced in Kratom Distribution Scheme United States v. Dailey Press Release On April 23, 2020, Judge Timothy Kelly of the U.S. District Court for the District of Columbia granted the United States motion to enter a stipulated order against Facebook, Inc. 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. Defendant Sentenced in Multi-Million-Dollar Prize Promotion Scams Targeting Elderly Victims United States v. Burke and RossiPress Release 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. At the time of their sentencings, both defendants had been incarcerated for approximately 4 years, including time spent in an English jail. Injunction Action Filed Against Drug CompounderUnited States v. Downing Labs, LLC et al.Press ReleaseDocket Number: 3:16-CV-003 (N.D.Tex.). In addition to entering the preliminary injunction, the court set a show cause hearing for May 11 regarding the defendants alleged violations of the previously issued temporary restraining order. Civil Case. District Court Permanently Enjoins 15 Individuals and Companies in Elder Fraud Mail Scheme Cal.). Docket Number: 1:20-cr-123; 1:20-cr-122 (W.D. Harkonen was convicted of wire fraud in 2009 for distributing a fraudulent press release designed to boost sales of his companys main drug. The order further requires the defendants to have the independent laboratory test their cheese products for the presence of Listeria, E. coli, and other bacteria. 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. The DPA relates to the companys role in knowingly selling consumer data to clients engaged in fraud. 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. Dietary Supplement Companies Sentenced in Case Involving Alleged Link to Liver Damage, U.S. v. USPLabs, 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. Docket Number: 3:18-CV-0127 (N.D. The Court also denied two motions to intervene in the case by a data privacy advocacy group and a private individual. On April 7, 2020, Pentax Medical Company entered into a deferred prosecution agreement in which it agreed to pay $43 million in criminal fines and forfeiture for violating the Federal Food, Drug, and Cosmetic Act. 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. 4:21-cv-00437-RLW (E.D. Both the plaintiff and the defendant are also referred to as "parties" or "litigants." As alleged in the information, Meds IV compounded various drugs for human use, including an intravenous drug known as Total Parenteral Nutrition (TPN). On December 21, 2022, the U.S Attorney's Office for the Eastern District of Michigan executed a settlement agreement with Julie B. Griffiths Law Office, a small law family practice in Flint, Michigan, under Title III of the ADA regarding failing to provide appropriate auxiliary aids and services to ensure effective communication for an individual who is deaf and uses American Sign Language. Trial for the remaining defendants is set for July 13, 2021. 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. On July 9, 2020, U.S. District Judge Kathleen M. Williams granted the governments motion for default judgment against the Genesis II Church of Health and Healing, along with two of the non-religious entitys four principals, Jordan Grenon and Jonathan Grenon, who were located in the United States. Press Release Press ReleaseDocket Number: 2:14-CV-4395 (E.D.N.Y.). According to the complaints, both sets of defendants manufacture their products without FDA approval and without proof of safety and efficacy. 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. Fla.). Examples of cases covered under civil law include negligence, fraud, breach of contract, medical malpractice and marriage dissolution. Docket No. Sentencing for Willson and Hebert is set for Aug. 22, 2019. 1. United States v. Becker et al., FDA had previously warned NAE, after inspections performed in 2013 and 2014, of its failures to maintain sanitary conditions. Victims were told they had won cars, boats, or other prizes they could claim by purchasing hundreds of dollars worth of vitamins. ); 2:14-CV-1156 (D.N.J. Court Denies Indivior's Motion to Dismiss Indictment Alleging Illegal Opioid Marketing The injunction prohibits defendants from manufacturing and distributing unapproved drugs, and, among other measures, requires Sonar to cease manufacturing until the company implements remedial measures, including establishing a quality assurance and quality control program and retaining an expert to conduct a comprehensive evaluation of Sonars operations. District Court Enters Permanent Injunctions Against Two New York Companies Banning the Importation of Dangerous ToysUnited States v. Everbright Trading, Inc. et al. Victims never received the promised winnings. On January 8, 2016, the district court entered a consent decree of permanent injunction against Downing Labs, LLC, Ashley Downing, Christopher Downing, and Roger Mansfield. Day and Davis were part-owners and the top managers of PacNet Services Ltd. (PacNet), a payment processing company based in Vancouver, British Columbia, Canada. District Court Enters Preliminary Injunctions Against Texas Doctors Who Prescribed Opioids With No Legitimate Medical PurposeUnited States v. Cesar B. Pena Rodriguez, M.D., and Leovares A. Mendez, M.D. On April 23, 2020, Judge Timothy Kelly of the U.S. District Court for the District of Columbia granted the United States' motion to enter a stipulated order against Facebook, Inc. It does not hear criminal cases. New Jersey Man Pleads Guilty to Large-Scale International Mass-Mailing Fraud SchemeUnited States v. Ryan Young In civil cases in the U.S., the person suing is known as the plaintiff while the person being sued is called the defendant. 371, and criminal contempt in violation of 18 U.S.C. Sentencing for Geissler, Doyle, Patel, and S.K. Hidalgo was arrested in 2016 by Peruvian authorities and extradited to the United States with two co-defendants last year. 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 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. In January 2014, Tahir Saeed also entered guilty pleas to several counts of the indictment, and was sentenced in October 2016 to time served. As the court found, Spectrum received about 1,600 reports of broken handles between 2008 and 2012, when it finally reported the problem to the CPSC. That scheme particularly affects elderly individuals throughout the country, and in several foreign countries. Among other provisions, the order bars the defendant from engaging in computer-security telemarketing, accepting payment for technical-support services, impersonating technology companies, and from conducting business through use of its email addresses in the @ozemioinc.com and @urgentechelp.com domains. Docket Number: 15-14400 (11th Cir.). 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. 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. British Man Indicted for Large-Scale Wire Fraud and Identity Theft SchemeUnited States v. Gareth David Long, Press Release According to the complaints, the CPSC collected dozens of samples of non-compliant toys and other childrens products from the defendants facilities and import shipments. On May 2, 2019, U.S. District Judge Robert Lasnik entered a preliminary injunction under 18 U.S.C. 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. Press Release 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. Docket Number: 2:20-cv-6692 (C.D. 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 The complaint alleges that consumers pay for items supposedly sold through the websites but never receive those purchases. 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. Cal.). 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. The settlement includes significant commitments by Moodys to improve its business practices, including: separation of Moodys commercial and credit rating functions; independent review and approval of changes to rating methodologies; changes to ensure that key personnel are not compensated on the basis of the companys financial performance; enhancing Moodys oversight over its press releases and methodology development; and certifications of compliance by the President/CEO of Moodys with these commitments for at least five years. The total $19.35 million in fine, forfeiture, and civil settlement payments constitutes the second largest-ever amount paid in resolution of a food-safety matter. According to the indictment, the aegeline-containing product was associated with a 2013 outbreak of severe liver injuries before being pulled from the market. Tex.). If your court offers it, look at electronic records over the internet. But the court left for the jurys determination at trial the issues of whether the defendants were liable for making deceptive claims, ignoring consumers prior do-not-call requests, and abandoning calls. In January 2014, Ul Haq entered guilty pleas to all 48 counts of the indictment, which charged him with conspiracy to import and distribute Schedule II, III, and IV controlled substances, conspiracy to defraud the United States and its agencies and introduce into interstate commerce misbranded drugs, conspiracy to commit international money laundering, and numerous substantive offenses of the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act. Chlorine dioxide, most commonly used as an industrial bleach, is a severe respiratory and eye irritant that can cause nausea, diarrhea and dehydration. In filings unsealed on January 29, 2021, U.S. District Judge Mary Scriven issued a temporary restraining order enjoining a Tampa pharmacy and two of its employees from dispensing opioids and other controlled substances. Sports Law, Civil Rights, Education Law Revived claims brought by several African-American college basketball players that their head coach . Case Number: Civil Appeal 008 of 2021. 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. Allen was also ordered to pay $117,000 in restitution. and Medical Devices, Justice for All Act (2004) Victims Notification, DECEPTIVE PRACTICES, TELEMARKETING,and DATA PRIVACY, Marketing Company Agrees to Pay $150 Million for Facilitating Elder Fraud Schemes, United States v. Epsilon Data Management, LLC The Court sentenced Roos to pay a fine of $100,000. In a criminal information previously filed in the District of Nevada, the United States charged FKOL with violating the Federal Food, Drug and Cosmetic Act by concealing and destroying records prior to a 2013 FDA plant inspection in Kalyani, India. Docket Number: 2:20-cv-279 (D. Utah). Employee of Chinese Chemical Supplier Sentenced in Scheme to Sell Mislabeled Dietary SupplementsUnited States v. GaoPress Release Calif.). The drugs were authorized and dispensed without any valid doctor-patient relationship; the websites linked to RX Limited focused on selling Soma, tramadol, and Fioricet directly to customers. According to the information, Bencosme and her co-conspiratorsincluding Bencosmes medical practice receptionist, Maytee Lledo, and two UM Research study coordinators, Jessica Palacio and Lisett Raventosfabricated 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. According to the information, Dr. Bencosme served as the principal investigator for a clinical trial conducted at Unlimited Medical Research intended to investigate the safety and efficacy of an experimental asthma medication in children between the ages of four and eleven. The violations stemmed primarily from norovirus outbreaks connected to employees failure to follow company food safety protocols at company-owned restaurants. 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. 20-CV-4218 (C.D. According to the indictment, the defendants mailings led victims, many of whom were elderly and vulnerable, to believe that they could claim large cash prizes in exchange for fees. The websites were linked to a large Internet pharmacy organization known as RX Limited. Indian Cancer Drug Manufacturer Sentenced for Concealing and Destroying Records in Advance of FDA Inspection. Docket Number: 2:17-CR-00004 (E.D. Under the terms of the DPA, Epsilon, a marketing company with principal sales operations based in Colorado, agreed to pay a total monetary penalty of $150 million, with $127.5 million of that amount going to compensate victims of the fraudulent schemes that used consumer data sold by Epsilon. United States v. Hisao YabePress Release Press ReleasePress Release 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. California Man Indicted in Transnational Fraud and Extortion SchemeUnited States v. Adrianzen, Press Release Published 12:11 AM EDT, Thu April 13, 2023. The complaint alleged the schemes targeted the elderly and generated approximately $4.8 million in annual victim losses. In the underlying lottery fraud scheme, the victim was falsely informed that she had won a lottery but had to pay various up-front fees. 841(a) and (b)(l)(B). District Court Issues First-of-its-Kind TRO to Stop Tennessee Pharmacies and Pharmacists from Dispensing OpioidsUnited States v. Oakley Pharmacy, Inc. et al. 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. The defendants conspired to smuggle at least 43 known shipments, totaling approximately 106,000 pills, from China to Texas. On February 7, 2019, U.S. District Judge Aleta Trauger issued a temporary restraining order against two Celina, Tennessee pharmacies, their majority owner, and three pharmacists, stopping them from continuing to dispense controlled substances. Fla.). For more information, see the Press Release dated May 1, 2020. Six defendants were convicted of conspiracy, mail fraud, and wire fraud charges following trial in 2015. On August 14, 2018, Xu Jia Bao (a/k/a Fred Xu) pleaded guilty to wire fraud in connection with a scheme to sell mislabeled dietary supplements containing hidden synthetic stimulants. Four Peruvian Residents Sentenced in Fraud and Extortion Scheme United States v. Jesus Gutierrez, Alexandra Podesta, Virgilio Polo, and Omar Portocarrero, Press Release The FDA has long warned against the use of SARMs, including stating in a publicly available 2017 warning letter that SARMs have been linked to life-threatening reactions including liver toxicity, and have the potential to increase the risk of heart attack and stroke. 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. For approximately 4 years, including time spent in an English jail,,... 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