In pleading guilty, Xu admitted that he agreed to falsely label for shipment a synthetic stimulant ingredient, namely DMHA. Fla.). Disclaimer: The information contained in this web site is provided as a service to the Internet community but does not constitute legal advice. The court also observed that even if it had jurisdiction to consider plaintiff’s challenge to the FDA guidance document, the plaintiff’s request to enjoin FDA from conducting an enforcement action was an impermissible attempt to test a defense pre-enforcement. Henry’s Farm manufactured and distributed a variety of soybean sprouts and repackaged and distributed mung bean sprouts. You would have to include the court which had heard the case. Tex.). Along with pleading guilty, the company agreed to pay a criminal fine of $30 million and forfeit an additional $20 million. 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. Both men pleaded guilty in July 2019 to conspiracy to alter odometers. 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. According to the information, Bencosme and her co-conspirators—including Bencosme’s medical practice receptionist, Maytee Lledo, and two UM Research study coordinators, Jessica Palacio and Lisett Raventos—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. Two of the individual defendants, Jacob Geissler and Jonathan Doyle, are expected to be sentenced in federal court in Dallas on October 13 and 15, 2020, respectively. Court Enters Temporary Restraining Order Against Fraudulent Online Stores Purporting to Sell COVID-19 Health and Safety ProductsUnited States v. Thu Phan Dinh, et al. In pleading guilty, Wall admitted that beginning in 2007, he managed a call center in Manila associated with RX Limited’s online pharmaceutical sales websites. Press ReleaseDocket Number: 1:16-CV-0348 (S.D. 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. The other two defendants are presently in the Republic of Colombia, and their time to answer the Complaint for Permanent Injunction had not yet expired. Docket Number: 1:16-CV-2770 (E.D.N.Y.). 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. Many alleged victims were elderly or otherwise vulnerable. Docket Number: 4:20-cv-46 (W.D. 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 company’s plant in Sylvester, Georgia. 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.). Ltd., an India-based company. Docket Number: 5:17-CR-50022 (D.S.D.). Docket Number: 2:19-cv-00324 (W.D. (respectively). The complaint alleged that FDA issued a warning letter to the company in 2018, and that tests in 2018 and 2019 revealed Listeria species inside the facility and E. coli in water used to irrigate sprouts. Vendstar sales representatives misrepresented to victims the likely profits they would earn, how past customers were doing, the availability of high-profit locations, and services that purported locating companies would provide. The company voluntarily terminated production at the plant on Feb. 14, 2007, and recalled all peanut butter manufactured there since January 2004. Long did not have authorization to charge any of these victims’ accounts. 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. United States v. Crawford, United States v. Brown, Office of International Judicial Assistance, Deceptive Practices, Telemarketing, and Data Privacy, Maven Infotech - The Summons and Complaint, in a publicly available 2017 warning letter, The Seventh Circuit upheld the lower court’s ruling here in May 2019. The defendants were executives of Acclarent, a start-up company that was acquired by Johnson & Johnson in 2010. Ark.). During a bench trial conducted last summer, the government presented evidence that each of the defendants had failed to comply with current good manufacturing practices, failed to keep records necessary to evaluate food safety, and processed fish in a way that could lead to Listeria monocytogenes contamination, all in violation of the federal Food, Drug, and Cosmetic Act (“FDCA”). Ressler’s sentencing is currently scheduled for June 12, 2018 at 10:00 a.m. before Judge Sam Haddon in Helena, Montana. The dealers, in turn, sold them to consumers. Docket Number: 1:21-cr-00006-RM (D. Colo.). On July 17, 2018, Gao Mei Fang (aka Amy Gao), a Chinese citizen, was sentenced to 12 months and a day of imprisonment on mail fraud and smuggling charges in connection with a scheme to sell mislabeled dietary supplements containing hidden synthetic stimulants. Fla.). ); 2:12-CV-2264 (D.N.J. §§ 331(d) and 333(a)(2). In pleading guilty, Raventos admitted that she conspired with others to fabricate the participation of subjects in the clinical trial and falsify clinical trial data. Argument on the remaining claims in the case, regarding the proper analysis of certain environmental risks, is expected to take place in May. The indictment alleges that over a five-year period, members of the conspiracy exploited personal identifiers of military members to steal millions of dollars. On October 12, 2018, Tully Lovisa, of Huntington Station, NY, pleaded guilty to conspiracy to commit mail fraud in connection with a mass-mailing scheme that brought in millions of dollars from victims. Court Permanently Enjoins Canadian Mass-Mailers From Sending Fraudulent Solicitations United States v. Thomas, et al. In October 2012, a federal district court in Texas ordered AA Foundries Inc. to take specific measures to prevent racial harassment of Black employees at its San Antonio plant following a $200,000 jury verdict finding the company liable for race discrimination under Title VII. The charges in the indictment stem from Indivior's marketing of Suboxone, an opioid drug used in the treatment of addiction. Sentencing before U.S. District Judge Beth Bloom is set for March 19, 2021, in Miami. Docket Number: 15-16844 (9th Cir./N.D. Cadden repeatedly took steps to shield NECC’s operations from regulatory oversight by the FDA by claiming to be a pharmacy dispensing drugs pursuant to valid, patient-specific prescriptions. On March 10, 2016, the government filed a complaint against KFJ Marketing, Sunlight Solar Leads LLC, Go Green Education, and the owner of those companies, Francisco Salvat, to halt a telemarketing campaign which failed to transmit accurate caller identification information, and resulted in 1.3 million illegal phone calls to consumers who had placed their phone numbers on the Do Not Call Registry. 1:20-cr-49 (W.D. On December 5, 2019, Trorice Crawford of San Diego pleaded guilty to one count of conspiracy to commit money laundering in connection with an identity theft scheme that allegedly targeted servicemembers and veterans. The DPA relates to the company’s role in knowingly selling consumer data to clients engaged in fraud. Under the Court’s order, the defendants may not manufacture or distribute their over-the-counter drug products from any facility owned or operated by the defendants unless they comply with specific remedial measures set forth in the injunction. Peruvian Man Sentenced to 88 Months of Imprisonment for Overseeing Call Centers that Threatened and Defrauded Spanish-Speaking U.S. Consumers, United States v. Rodolfo Hermoza The entry of the permanent injunction resolves the litigation. Rodis’ co-defendants recruited and trained telemarketing staff to answer consumer calls, during which sales staff routinely lied to homeowners about the firm’s success rates, ability to obtain loan modifications, and, at times, directed homeowners to stop making mortgage payments. U.S. District Court Judge Robert Pitman has scheduled the sentencing hearing for Blue Bell Creameries for September 17, 2020. The citation is basically the information which would state where the case was published and it should be included in your brief. On January 8, 2021, Dr. Yvelice Villaman Bencosme pleaded guilty to conspiracy to commit wire fraud in connection with an alleged clinical trial fraud scheme at a Miami clinical research company, Unlimited Medical Research. (respectively). The injunction, which will last for at least five years, follows an October 20, 2015 order in which the court granted the government’s motion for summary judgment, finding that the defendant company, Serra Cheese, was adulterating cheese products under the Food, Drug, and Cosmetic Act. 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. Ninth Circuit Affirms Conviction in Miracle Cure CaseUnited States v. Louis Daniel SmithPress Release Martin Valdes, Fidalgis Font, Julio Lopez, and Duniel Tejeda—with engaging in a scheme to fabricate clinical trial data for profit while working at Tellus Clinical Research, a Miami medical clinic. Cal.). In addition to the company’s guilty plea, Roos, and its principals, Ana A. Roos and Virginia Mejia, agreed to a consent decree of permanent injunction. In addition, S.K. Docket Number: 3:17-CV-1005 (S.D. The court previously entered a default judgment against the entity and two principals located in the United States. Fla.). On February 26, 2021, U.S. District Judge Randolph Moss denied Plaintiff MediNatura Inc.’s second motion for a preliminary injunction against the government. They were told to pay thousands of dollars to Smith and others in order to collect their winnings. The jury also determined that defendant Forrest Baker had authority to control the corporate defendants and participated in their practices and was therefore personally responsible for the violations. Smith is a Jamaican national living in the United States. Spanning 20 countries, Operation Shrouded Horizon has dismantled an online criminal forum. On June 12, 2020, Judge Ronnie Abrams sentenced Paul Calder Leroux to 25 years’ imprisonment in connection with various criminal activities, which included operating a long-running Internet pharmacy operation known as RX Limited. Fla.). Docket Number: 1:15-cr-20471 (S.D. Trial is set to begin in Abingdon, Virginia on May 11, 2020. On December 1, 2014, the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Neptune Manufacturing Inc. of Los Angeles and its corporate officers, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky, to prevent the distribution of adulterated seafood products. ; United States v. Harati et al.Press ReleaseDocket Numbers: 8:14-CR-0198-DSF; 8:15-CR-0041 (C.D. ); 2:14-CV-1156 (D.N.J. 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. );2:16-CV-12655 (E.D. Specifically, the complaint alleges that the defendants routinely dispensed controlled substances while ignoring numerous warning signs of diversion and abuse, such as unusually high dosages of oxycodone and other opioids, prescriptions for opioids and other controlled substances in dangerous combinations, and patients travelling extremely long distances to obtain and fill prescriptions. The government’s 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. After returning to the United States in 2008, Wall used phony names to obtain wholesale pharmaceutical licenses from several states in the hope of selling wholesale quantities of drugs directly to RX Limited’s dispensing pharmacies. According to the complaint filed in the case, the defendants send fraudulent solicitations styled as notifications that the recipients have won large cash prizes, typically said to be worth more than $1 million. 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. The settlement follows an investigation by the Consumer Protection Branch and the U.S. Attorney’s Office for the District of New Jersey into potential claims pursuant to the Financial Institutions Reform, Recovery and Enforcement Act (FIRREA) and investigations conducted by various State Attorneys General pursuant to state law. Docket Number: 1:18-CV-22016 (S.D. and Mark Berman, M.D. PharMedium also must take remedial measures to ensure compliance with the FDCA at its other facilities and at its headquarters in Illinois. Richard Goldberg Facebook Agrees to Pay $5 Billion and Implement New Protections of User Information in Settlement of Data-Privacy ClaimsUnited States v. Facebook, Inc. Press Release From January through July of 2013, Long created and deposited more than 750,000 unauthorized checks totaling more than $22 million. An information filed the same date charged the company with two misdemeanor counts of adulterating food in violation of the Federal Food, Drug, and Cosmetic Act. Mass.). Justice Department Files Suit Against Tampa-Area Physician, Pharmacy, and Clinic Owners for Opioid-Related Controlled Substances Act Violations. Victims of the scheme received telephone calls about substantial lottery prizes they supposedly had won. P. 16, and the parties having submitted a proposed discovery plan, the Cour t enters the following schedule to manage the Va.). Docket Number: 1:20-cr-123 (W.D. District Court Enters Permanent Injunction Against Chicago Sprout and Soybean Products Company, United States v. Fortune Food Product, Inc. et al. Okla.). In filings unsealed on February 9, 2021, Indian drug manufacturer Fresenius Kabi Oncology Limited (FKOL) agreed to plead guilty to concealing and destroying records prior to a 2013 FDA plant inspection in Kalyani, India. Following a hearing, the court entered an order allowing the government to seek liquidated damages for further violations and imposing other restrictions aimed at curtailing Kimura’s participation in the schemes. District Court Enjoins Pennsylvania Compounding Pharmacy from Distributing Adulterated DrugsUnited States v. Ranier’s Rx Laboratory, Inc., et al. Lytle argued on appeal, inter alia, that his plea was obtained by coercion, that he was not competent to plead guilty, and that his counsel was ineffective. The defendants are scheduled to be sentenced early next year. Some solicitations instruct recipients to pay a fee in order to receive their winnings; others urge recipients to purchase goods or services based on false promises that they will guarantee future lottery wins. The indictment alleges that Reyes purchased and received at his home counterfeit THC vaping products from China. 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. The court’s 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. On February 19, 2016, Joseph Dallal was sentenced to serve 33 months in prison in connection with two separate prescription drug diversion schemes. Case No. The products had not been approved by Food and Drug AdminIstration. 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