The firm sold their soups to various distributors after receiving seafood from other states including Florida. 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. View more updates. The statements address the effects of cigarette smoking and the fact that cigarettes are deliberately designed to create and sustain addiction. Long did not have authorization to charge any of these victims’ accounts. Runner was arrested in Spain, and extradition proceedings have been initiated in Spanish court. Lytle and another QLaser distributor, Irina Kossovskaia, were indicted earlier this year on related charges of mail fraud, wire fraud, conspiracy, and contempt. Docket Number: 1:16-CV-5264 (E.D.N.Y.). Docket Number: 3:09-CV-03073 (C.D. § 1345), was filed against a John Doe defendant standing in for the operator of the website, whose true identity remains unknown. According to an indictment returned last October, Xu agreed with a confidential government informant to mislabel synthetic stimulants arriving in the United States or otherwise help to hide from retailers the true nature of a proposed new dietary supplement. In return, victims received worthless costume jewelry. Lovisa also pleaded guilty to wire fraud in connection with a related scheme to defraud the Federal Trade Commission, which previously sued him regarding an earlier prize-promotion mailing business. 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. Tex). Cal.). The government alleged in a February complaint that Navigator Marketing Ltd., a Canadian company, and Rockport Promotional Marketing, LLC, a Delaware registered corporation, and the corporations’ principals, Alexander Quaglia, Rychard McKeown, and Brent Nishiguchi, all of British Columbia, Canada, operated an international fraud scheme that mailed solicitations informing recipients that they would receive large sums of money after payment of a small fee. OxyElite Pro was recalled in 2013 after being linked by the Food and Drug Administration to a deadly outbreak of serious liver injuries. Later, those published decisions were used as the basis to decide similar cases. Altogether, 22 individuals were convicted of fraud in connection with Vendstar. Tex.). District Court Finds Websites to be “Labeling” Under FDCA in Denying Motion to Dismiss Enforcement ActionUnited States v. Innovative BioDefense, Inc. et al. Employee of Chinese Chemical Supplier Pleads Guilty in Scheme to Sell Mislabeled Dietary Supplements United States v. XuPress Release Docket Number: 1:20-cr-20190 (S.D. ); 2:12-CV-2264 (D.N.J. L. mono can cause listeriosis, a disease that can be serious, and even fatal, for vulnerable groups such as newborns and those with impaired immune systems. Miss.). Alabama Seafood Soup Producer Signs Consent Decree in Connection with Distribution of Adulterated and Misbranded FoodUnited States v. BEK Catering, LLC d/b/a Floppers Foods, et al. On November 14, 2019, the court denied Indivior's motion to dismiss a 28-count indictment alleging the company engaged in healthcare fraud, wire fraud, mail fraud, and conspiracy. Marks also arranged for other U-Turn sales representatives to serve as phony references during his attempted sales, and Marks served as a phony reference for other sales representatives. The $36 million global resolution relates to the medical device LC Bead, which is used to treat liver cancer. 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 Docket Number: 8:20-cv-1794 (M.D. More than 750 patients in 20 states were diagnosed with a fungal infection after receiving injections of methylprednisolone acetate (MPA) compounded at NECC. Virginia Sprout Producer Agrees to Consent Decree in Connection with Distribution of Adulterated FoodUnited States v. Henry's Farm Inc., and Soo C. Park, Press ReleaseDocket Number: 3:16-CV-0089 (E.D. In a complaint filed February 1, 2019, the United States alleged that the defendants violated the Food, Drug, and Cosmetic Act by causing drugs to become adulterated. The defendant also was ordered to make restitution payments to victims. Press ReleaseDocket Number: 1:16-CV-0348 (S.D. Following a jury trial in the Southern District of Florida, Mathauda was sentenced to 200 months’ imprisonment. According to the complaint, FDA inspections of the Cantrell facility documented evidence of insanitary conditions and significant deviations from current good manufacturing practice requirements, including records showing the company detected potentially dangerous bacteria in the air and on surfaces used for sterile processing. If the objection is sustained, the witness does not answer the question, and the attorney must move on to his next question. California Man Indicted in Transnational Fraud and Extortion Scheme United States v. Adrianzen, Press Release One 2,460 % potent lot of Pharmakon morphine sulfate nearly caused the death of an infant at an Indianapolis hospital in 2016. On December 14, 2015, the district court entered a consent decree against the Correia Farm Limited Partnership d/b/a Wynsum Holsteins, a dairy farm located in West Addison, Vermont, and its co-owners Anthony and Barbara Correia and their son and limited partner Stephen Correia, to prevent violations of the federal Food, Drug and Cosmetic Act (FDCA). Six defendants were convicted of conspiracy, mail fraud, and wire fraud charges following trial in 2015. 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. Eleventh Circuit Affirms Sentence of Business Opportunity FraudsterUnited States v. Sirtaj “Tosh” Mathauda He also hid evidence from FDA inspectors and destroyed evidence while law enforcement agents were executing search warrants on his residence and business locations. Fla.); 5:16-CV-0577 (M.D. In a July 2017 complaint, the government alleged that the defendants promoted and sold misbranded sexual enhancement products that contained the undisclosed ingredient sildenafil, which is the active pharmaceutical ingredient in Viagra. In pleading guilty, Baine admitted that between 2011 and 2014, he caused the odometers on at least 387 vehicles to be rolled back to false, lower mileages and then sold to unsuspecting consumers from his car lot in Gulfport, Mississippi. (criminal case)Docket Number: 1:16-CV-0032 (D. These defendants ran a mail fraud scheme in which victims received letters from alleged world-renowned psychics, offering purportedly personalized psychic predictions and services for a fee. Trial began on May 16 and lasted eight days. Final proceeds from the sale of these properties will go toward restitution payments in the fraud case. Sentencing for Geissler, Doyle, Patel, and S.K. Defendants Sentenced in Connection with Internet Pharmacy SchemeUnited States v. Onochie Aghaegbuna; United States v. Jonathan WallDocket Number: 0:13-CR-273 (D. Minn.). D’Antonio’s two co-defendants, Ronald Rodis and Charles Wayne Farris, previously pled guilty. 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 animal’s genome as a new animal drug. The information also alleges that Palacio knowingly and falsely claimed in an affidavit to the FDA that a particular subject participated in the trial when, in fact, that subject had not so participated. Rodis was paid for the use of his law license in an effort to lend legitimacy to the operation. Want to further develop your knowledge of the federal courts? S. marcescens is a bacteria that can cause bloodstream infections if introduced into the bloodstream through contaminated medications. Docket Number: 2:16-cr-71 (D. Nev.). Cal.). 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. The complaint further alleges that the Zylast products are misbranded because of marketing claims stating that FDA considers Zylast’s active ingredient “safe and effective in open wounds” and “safe and effective for first aid” when FDA has not made such determinations. District Court Enters Permanent Injunction Against Utah Pharmacy and Individuals to Prevent Distribution of Adulterated and Misbranded Drugs and Unapproved New DrugsUnited States v. Isomeric Pharmacy Solutions, LLC, et al. Del.) Likely the most prominent example of this scenario is the OJ Simpson case—his criminal charges were dismissed, but the family of the victim was able to successfully sue him in civil … 1, 2018, filed a motion seeking a preliminary injunction against Cantrell Drug Company and its co-owner and Chief Executive Officer, James L. McCarley, Jr., to stop the manufacturing and distribution of adulterated drugs. In addition to the prison term, the court also ordered Crawford to pay $103,700 in restitution. With reference to the case study, explain two reasons why civil law is needed. Docket Number: 1:16-CR-0450 (D. Acino manufactures hydrocortisone acetate 25 mg suppositories, which it labels and sells as prescription drugs. Defendant Sentenced in Connection with a Lottery Scam Based in JamaicaUnited States v. Felecia Roxanne Lindo Docket Number: 2:20-cv-279 (D. Utah). Docket Number: 2:14-cr-126 (E.D. The Indictment also charged Lytle with obstruction of FDA proceedings. Many homeowners lost their homes to foreclosure after hiring the firms. In pleading guilty, Bearden admitted that she and her co-defendant, Paul J. Elmer, Pharmakon’s former president, lied during multiple FDA inspections about test results concerning under- and over-potent compounded sterile drugs manufactured by Pharmakon and distributed to hospitals nationwide. Crawford admitted that he recruited at least 30 individuals to serve as money mules to receive funds stolen from servicemembers and veterans, and that he arranged to remit stolen funds to other co-conspirators in the Philippines. Docket Numbers: 1:19-cr-87; 1:19-cr-88 (S.D. 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. Victims who send payments receive no prize. Fla.) In a stipulated order filed with the complaint, Facebook agreed to settle these allegations by paying a $5 billion civil penalty and implementing robust, new compliance measures that will change how Facebook prioritizes and approaches user privacy issues. then “refereed” by the judge, who has somewhat greater flexibility than in a civil law system to fashion an appropriate remedy at the conclusion of the case. United States v. Hidalgo et al. 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 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. 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. Ronald Rodis was paid for the use of his law license in an effort to lend legitimacy to the operation. In reality, these companies were telemarketing operations that did very little to help homeowners after they paid upfront fees ranging from $3,500 to $5,500. As part of the fraud plea, Adrianzen admitted that he partnered with call centers in Peru that took money from vulnerable and elderly U.S. Spanish-speaking victims through lies and threats. Jury Finds All Defendants Liable in Utah Telemarketing CaseUnited States v. Feature Films for Families, Inc., et al.Docket Number: 2:12-CV-0811 (D. Utah). 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. Several FDA inspections since 2011 revealed violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations and current Good Manufacturing Practice regulations. The remaining two defendants, Mark Grenon and his adult son, Joseph Grenon, are now permanently enjoined from distributing “Miracle Mineral Solution,” an industrial bleach product the defendants touted as a cure for COVID-19 and a plethora of other serious diseases. Current cases. On August 3, 2015, the district court entered an order of permanent injunction against Henh Wong Fresh Produce, a sole proprietorship, its owner, David C. Ly, and employees Kin S. Ly and Thahn “Danny” C. Ly, to stop them from violating the Food, Drug, and Cosmetic Act (FDCA) by causing food to be adulterated while it is held for sale after shipment in interstate commerce. Smith was also ordered to pay $724,408.79 in restitution. Several inspections of the firm’s facility between 2012 and 2014 revealed numerous violations of FDA’s current good manufacturing practice regulations, including the failure to use equipment and utensils of appropriate design, construction and workmanship to enable them to be adequately cleaned and properly maintained. Before closing in July 2010, Vendstar made approximately $10 million to $12 million in sales per year. Palmer and her friend kept a portion of the money, and Palmer wire transferred the rest to her Jamaican co-conspirator. The material was found on Adrianzen’s cell phone and laptop computer when government agents executed search warrants on both devices in connection with an unrelated fraud investigation. According to the plea agreement, Onyx was approved by the U.S. Food and Drug Administration (FDA) as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain.. 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. 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. 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. Olympus was ordered to pay $85 million in criminal fines and forfeiture, and also agreed to enact extensive compliance reforms. Chicago Dietary Supplement Companies Ordered to Comply with FDCA United States v. Global Marketing Enterprises, Inc., et al.Press Release ); 2:14-CV-1156 (D.N.J. Docket Number: 2:17-CV-14038 (S.D. Many victims received nothing; others received only a cheap piece of jewelry or a report listing unrelated sweepstakes. The injunction permanently enjoins the defendants from distributing unapproved, misbranded, and adulterated drugs in violation of the Food, Drug, and Cosmetic Act. The defendants had an extensive history of operating their food manufacturing facility under insanitary conditions, failing to follow current good manufacturing practice requirements and misbranding their food products. Docket Number: 15-10399 (11th Circuit) Docket Number: 2:20-cv-279 (D. Utah). On June 6, 2018, the United States filed a civil action seeking to enjoin Innovative BioDefense, Inc., of Lake Forest, California and its CEO, Colette Cozean, from distributing “Zylast” antiseptic hand sanitizer products that are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. During the course of the scheme, Rodis Law Group and a successor company, America’s Law Group, obtained more than $9,000,000 from over 1,800 homeowners. The list includes civil cases filed two weeks preceding the previous business day. On October 29, 2019, Fredrick Brown, a former civilian contractor stationed at Yongsan Garrison, a US Army installation in South Korea, pleaded guilty to one count each of conspiracy to commit wire fraud and conspiracy to commit money laundering in connection with the same scheme. Docket Number: 5:17-CR-50020-KES (D.S.D/8th Circuit). );2:16-CV-12655 (E.D. The FDA has approved Onyx only for use inside the brain. The civil penalties include $168 million payable to the United States related to at least 66 million illegal calls by Dish and its retailers. On Nov. 21, 2017, the district court entered consent decrees against defendants BDK Mailing GmbH, Mailing Force Pte, Ltd., Only Three Pte. New Jersey Man Pleads Guilty to Large-Scale International Mass-Mailing Fraud SchemeUnited States v. Ercan Barka District Court Issues Temporary Restraining Order Blocking Multi-Million Dollar Elder Fraud Schemes United States v. Kafeiti et al. Fla.). Government Files Complaint for Permanent Injunction Against New Jersey Maker of Ultrasound Gels United States v. Pharmaceutical Innovations Inc. and Charles Buchalter; Pharmaceutical Innovations, Inc. v. U.S. Food & Drug Admin; Docket Number: 8:18-cv-996 (C.D. In a complaint filed with the consent decree, the United States alleged that the fish at defendants’ facility was processed under insanitary conditions, chiefly because the defendants failed to adequately control the growth of Listeria monocytogenes. The Court rescheduled all sentencing hearings in this matter to July and August 2020. According to the indictment in the case, between 2008 and 2013, USP Labs marketed the highly successful workout supplements Jack3d and OxyElite Pro, which contained a synthetic stimulant known as DMAA. Richard Goldberg The court’s order followed an eight-day bench trial that concluded in March. After four hours of deliberation, the jury found the defendants liable for the United States’ remaining claims and concluded that they committed more than 117 million knowing violations of the TSR. According to the complaint, United States residents received fraudulent direct mail solicitations that falsely claimed that the recipients had won, or would soon win, cash or valuable prizes or otherwise come into great fortune. Air was pushed into the clean room through the HEPA filters. According to the complaints, both sets of defendants manufacture their products without FDA approval and without proof of safety and efficacy. The department filed a complaint in the U.S. District Court for the Central District of California on Nov. 21 alleging that Neptune’s seafood products are produced under conditions that are inadequate to ensure the safety of its products. The court found that the government's actions before the grand jury were neither improper nor misleading, and the court denied Indivior's motion to dismiss the indictment. Mich.), Court Enters Injunction Against Seafood Manufacturer in California. 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