According to the complaint in the case, the defendants mailed more than 1 million solicitations to potential victims in the United States, France, Germany, the Netherlands, Japan, and elsewhere, grossing about $4.5 million annually since 2016. The complaint alleges that the defendants, as part of a wire fraud scheme, created 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. Some victims lost thousands of dollars. Many homeowners lost their homes to foreclosure after hiring the firms. ACell manufactures and distributes MicroMatrix, a powder wound dressing produced from porcine bladder tissue. The injunction requires the defendants to destroy dietary supplements that are in their possession and implement several consumer safety measures before resuming the manufacturing or distributing of dietary supplements. On March 24, 2020, U.S. District Judge Eric Komitee entered a preliminary injunction under 18 U.S.C. On June 21, 2016, David Allen and William Rogers were sentenced to 12 months and 10 months in prison, respectively, in connection with the distribution of adulterated drugs. Olympus was ordered to pay $85 million in criminal fines and forfeiture, and also agreed to enact extensive compliance reforms. 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. 1:20-cr-49 (W.D. The indictment alleges Indivior employees encouraged misuse of Suboxone through relationships with doctors engaged in illegitimate prescribing and made fraudulent claims about the safety and diversion of the drug. Physicians & Surgeons v. FDA. Dallal was previously charged in the District of Puerto Rico and the Southern District of Ohio for selling illegally-sourced prescription drugs in connection with two distinct drug diversion schemes. 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. In some instances, a person may be entitled to file a complaint, trusting the legal system to punish the wrongdoer with prosecution, while bringing a civil lawsuit to receive compensation for the damages done by the wrongdoer. 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. Victims were told they must urgently pay fees to collect their winnings. Shaw also was ordered to pay $128,440 in restitution. SHARE The Supreme Court, the Sabbath and a much-debated piece of civil rights law. Indivior also is alleged to have sought to boost profits by using a Here to Help program to connect opioid-addicted patients to doctors the company knew were prescribing opioids at high rates and in a clinically unwarranted manner. According to charges, Gore sent collection letters to victims of the psychic scheme after the victims checks bounced. The courts order followed an eight-day bench trial that concluded in March. The indictment further alleged that the defendants imported synthetic ingredients from China using false certificates of analysis and false labeling, and lied about the source and nature of those ingredients to retailers and consumers. Press release In a complaint filed June 4, 2018, the United States alleged that inspections at Delta Pharmas facility found numerous insanitary conditions and deviations from current Good Manufacturing Practice requirements, including failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. SHARE. Under the terms of the agreement, B. Braun will increase oversight of its product suppliers by conducting on-site audits of companies that design and make finished products that bear the B. Braun name on the label or logo and testing such products for sterility, identity and purity, as appropriate, on a periodic basis. The verdict is the latest development in a lawsuit that the Department filed on behalf of the Federal Trade Commission (FTC) in May 2011, seeking, among other things, a permanent injunction and civil penalties against the defendants for engaging in widespread deceptive and abusive telemarketing practices in the course of selling and promoting DVDs and films. He also hid evidence from FDA inspectors and destroyed evidence while law enforcement agents were executing search warrants on his residence and business locations. Eleventh Circuit Affirms Sentence of Business Opportunity FraudsterUnited States v. Sirtaj Tosh Mathauda 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 Kimuras participation in the schemes. 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. In civil cases in the U.S., the person suing is known as the plaintiff while the person being sued is called the defendant. On June 26, 2017, Barry Cadden, the owner and head pharmacist of New England Compounding Center (NECC), was sentenced to nine years (108 months) of imprisonment, three years of supervised release, and forfeiture and restitution in amounts to be determined later. The Seventh Circuit upheld the lower courts ruling here in May 2019. FDA inspections over the past three years have revealed multiple and repeated violations of the Food, Drug, and Cosmetic Act (FDCA) by Downing in the manufacture of compounded sterile injectable drugs. Texas Resident Pleads Guilty to Illegal Importation of Counterfeit Vaping Products. The complaint alleged that defendants had a history of processing food products under insanitary conditions. Court Denies Indivior's Motion to Dismiss Indictment Alleging Illegal Opioid Marketing 371, and criminal contempt in violation of 18 U.S.C. Allen was also ordered to pay $117,000 in restitution. 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. Armistead received $7,500 in cash from a victim in Maryland and deposited most of that money into accounts of a co-coconspirator. Lawrence A. Kaplan, who was Vendstars technical support manager, a position in which he stifled complaints to keep the scheme going, was sentenced to 54 months in prison. The action, brought under the anti-fraud injunction statute (18 U.S.C. 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. Spokane, Washington Man Sentenced to 51 Months Imprisonment for Selling Industrial Bleach as Miracle Cure United States v. Smith, Press ReleaseDocket Number: 2:13-CR-14 (E. D. Wash.). Blue Bell pleaded guilty to two misdemeanor counts of distributing adulterated ice cream products and has agreed to pay a criminal fine and forfeiture amount totaling $17.25 million according to the terms of a plea agreement. One of the primary ingredients sold by Romeos companies was powder purportedly derived from a rare South African cactus called hoodia, which was claimed to have weight-loss properties. Docket Number: 5:12-CR-0141 (N.D. Ga.). Summary Judgment Granted Against Manufacturer of Adulterated Dietary Supplements. Former Virginia Physician Sentenced for Role in Internet Pharmacy Operation, United States v. Ryan (E.D. United States v. WeCare Pharmacy, et al. Charges Unsealed Against Three Individuals Alleged to Have Operated Massive Mail Fraud Scheme United States v. Thanos, United States v. Lett, United States v. Runner Fla.). The clinical trial sought to compare the efficacy of two asthma treatments in a pediatric population. 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. Press Release Docket Number: 8:20-cv-1794 (M.D. Per this policy, in unlimited civil cases a party who has received a fee waiver may request an official court reporter Estate Planning. The government alleged that FKOL plant management directed employees to remove certain records from the premises and delete other records from computers that would have revealed FKOL was manufacturing drug ingredients in contravention of FDA requirements. Docket Number: 1:17-CR-00113 (S.D. 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. Complaint for Injunctive Relief and Civil Penalties Filed Against Online Consumer Background Report Provider MyLife.com United States v. MyLife.com, Inc. et al.Press Release Medical Doctor Pleads Guilty in Clinical Trial Fraud Scheme. On October 30, 2020, Lisett Raventos of Miami, Florida, pleaded guilty to one count of conspiracy to commit wire fraud in connection with an alleged clinical trial fraud scheme at a Miami clinical research company, Unlimited Medical Research. Allen was the former pharmacist-in-charge of Meds IV and Rogers was the former president of Meds IV. Case No. The verdict was the first ever in an action to enforce the Telemarketing Sales Rule and Do Not Call Registry rule. As part of their guilty pleas, Hidalgo and Hermoza admitted that they and others they supervised called consumers in the United States falsely claiming to be attorneys and or government representatives. He instructed consumers to combine MMS with citric acid to create chlorine dioxide, add water and drink the resulting mixture to cure numerous illnesses. As part of his plea, Dailey agreed to forfeit $1,000,000 in illegal proceeds. Tex.). The websites were linked to a large Internet pharmacy organization known as RX Limited. Defendant Sentenced for Conspiring to Defraud the FDA and for Distribution of Over- and Under-Potent Compounded DrugsUnited States v. Paul Elmer and Caprice BeardenPress Release 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. Docket Number: 8:20-cv-1794 (M.D. 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. The district court ordered Spectrum to pay $1.9 million in civil penalties, maintain adequate systems and controls to prevent future violations, and retain an outside consultant to evaluate its compliance program. As a result, in March 2017, the United States sought and obtained the courts appointment of a second realtor in addition to the defendants realtor to attempt to sell the properties. Court Dismisses Challenge to FDAs Emergency Use Authorization for Hydroxychloroquine Related to COVID-19 Assn of Am. 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. DAntonio was previously convicted of wire fraud for a separate work-at-home scheme involving medical billing and was also subject to a permanent injunction banning him from any involvement in a company engaged in telemarketing. Docket Number: 2:17-CV-072773 (C.D. Court Enters Injunction Against California Producer of Adulterated and Misbranded Soy ProductsUnited States v. Wa Heng Dou-Fu & Soy Sauce Corporation, Peng Xiang Lin and Yuexiao LinPress ReleaseDocket Number: 2:16-CV-1358 (E.D. Over the centuries many civil courts were created to deal with different branches of the law. On June 24, 2019, Michael Carey Eubank pleaded guilty in the Eastern District of Virginia to one count of conspiracy to commit odometer tampering. Altogether, 22 individuals were convicted of fraud in connection with Vendstar. 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). S. marcescens is a bacteria that can cause bloodstream infections if introduced into the bloodstream through contaminated medications. Both the plaintiff and the defendant are also referred to as "parties" or "litigants." According to the complaint, FDA inspections performed in 2012, 2013 and 2014 revealed that the companys dietary supplements are adulterated within the meaning of the Food, Drug, and Cosmetic Act because the company failed to follow various requirements, including testing its dietary ingredients to verify their identity before using them. The guidelines for these disputes are outlined in official documents like a state's business and professions code, the health and safety code, and other governmental rules and regulations. Docket Number: 2:20-cv-10032 (E.D. Sentencing before U.S. District Judge Beth Bloom is set for April 16, 2021, in Miami. In 2012 and 2013, Burnett bought high-mileage used cars, altered the mileage on the titles, rolled back the odometers, obtained new titles with false low mileages, and sold the cars to unsuspecting dealers. Xu was arrested at a Las Vegas dietary supplement trade show in September; two other defendants previously pleaded guilty in a related case. The remainder will be distributed among the settlement member states in alignment with terms of the agreement. Four Individuals Charged in Connection with Clinical Trial Fraud Scheme. 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. 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 same time, the court sentenced the principals of Quality Egg, Austin Jack DeCoster and Peter DeCoster, each to pay a $100,000 fine and to serve three months in prison followed by a year of supervised release. 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. 1343. Three other individuals Patti Kern, Edgar Del Rio, and Sean OConnor pleaded guilty to conspiracy to commit mail fraud in 2019. The conflict started with an Amazon contract. 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. Evidence at trial showed PCA products sickened hundreds and likely thousands of people during an outbreak of salmonellosis in 2008-09. Defendants Sentenced in Connection with Internet Pharmacy SchemeUnited States v. W. Scott HarkonenDocket Number: 15-16844 (9th Cir./N.D. Justice Department Obtains $1.4 Billion from Reckitt Benckiser Group in Largest Recovery in a Case Concerning an Opioid Drug in United States HistoryUnited States v. $647,000,000 in U.S. CurrencyPress Release 1:20-cv-02066 (D.D.C.). The district court found that Spectrum and its former subsidiary, Applica Consumer Products Inc., violated the Consumer Product Safety Act by waiting years to inform the Consumer Product Safety Commission (CPSC) of customer reports that handles on Black & Decker-brand coffee carafes suddenly could break and create a burn hazard from hot coffee. On February 3, 2016, Catherine Nix was sentenced to 15 months imprisonment, and on October 6, 2015, Wada Hollis and Thomas Giddens were also sentenced to 15 months imprisonment for their roles in in a prescription drug smuggling ring. In pleading guilty earlier this year, Gao admitted that she knew major American dietary supplement retailers would refuse to carry supplements known to contain certain stimulants, such as DMAA. Defendant Sentenced in Multi-Million-Dollar Prize Promotion Scams Targeting Elderly Victims United States v. Burke and RossiPress Release Consent Decree Entered Against California Dietary Supplement CompanyUnited States v. Scilabs Nutraceuticals, Inc. and Paul P. EdalatPress ReleaseDocket Number: 8:14-CV-1759 (C. D. On October 2, 2014, the United States filed a complaint for a permanent injunction against Pharmaceutical Innovations Inc. and its founder, owner, and chairman, Gilbert Buchalter, for violations of the Federal Food, Drug and Cosmetic Act (FDCA). An official website of the United States government. 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. 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. A civil action or suit starts when individuals or corporations disagree on a legal matter, such as the terms of a contract or the ownership of a piece of property. The Indictment also charged Lytle with obstruction of FDA proceedings. The decrees against Hill and Woods were entered on February 26, 2016, and June 27, 2016, respectively. On May 27, 2020, U.S. District Court Judge Ronald A. Fla.). The Court previously enforced an identical waiver in dismissing the appeal of one of Lytles co-defendants. Complaints for Permanent Injunction Filed Against Two Companies Purporting to Offer Stem Cell Treatments for Serious Diseases United States v. US Stem Cell Clinic, LLC, et al. 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. United States Seeks Preliminary Injunction Against Arkansas Compounding PharmacyUnited States v. Cantrell Drug Co. et al.Press Release From July 2008 until May 2012, Marks made sales from an office in Brooklyn, New York, on behalf of U-Turn Vending, which was based in Idaho. Court Enters Permanent Injunction Against New York Creamery Linked to Deadly Listeria OutbreakUnited States v. Vulto Creamery et al.Press Release The injunction further requires Dr. Reddys to maintain internal controls and procedures designed to ensure timely, truthful, complete, and accurate reporting of such issues to the Commission. Defendant Pleads Guilty in Clinical Trial Fraud Scheme. The indictment alleges that Mario Castro, Jose Salud Castro, Salvador Castro, Miguel Castro, and Jose Luis Mendez all worked at printing and mailing businesses that sent the fraudulent mailings and shared in the resulting profits. 1345 against three Vietnamese defendants, Thu Phan Dinh, Tran Khan, and Nguyen Duy Toan. In pleading guilty, Akinyoyenu admitted that he paid a doctor to review thousands of prescription drug orders for a small fee per order. Working with her co-conspirator in Jamaica, Palmer recruited a friend in Maryland to receive $7,500 of the victims money. They are expected to enter guilty pleas to the informations, which were filed in the U.S. District Courts for the Eastern District of Louisiana and Middle District of Florida. The order also compels the company to issue notices to its customers disavowing past COVID-19 claims, offer full refunds to affected customers, and enter a robust compliance plan to prevent future violations of the Federal Food, Drug, and Cosmetic Act, among other statutes. 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. On May 22, 2019, Hisao Yabe was sentenced to one year of probation and fined $5,000 for his failure to report to the Food and Drug Administration information that called into question the safety of a medical device manufactured by Olympus Medical Systems Corporation. Harkonen was convicted of wire fraud in 2009 for distributing a fraudulent press release designed to boost sales of his companys main drug. According to the complaint filed in the case, the defendants manufactured and distributed adulterated dietary supplements not prepared in compliance with current good manufacturing practices. Under the order, the defendants may not prepare, process, manufacture, pack and/or hold FDA-regulated food products until they can ensure that L. mono is not present in their facility and their food, and until they have received FDAs written determination that their manufacturing practices comply with the law. (Joel) Frantzman, to prevent the distribution of adulterated seafood products. The solicitations misled recipients into believing that they would receive large sums of money or powerful talismans for payments of $50 to $55. The court in both matters granted temporary restraining orders to limit the defendants ability to distribute or dispense controlled substances. Tex.). The multi-faceted settlement includes a Statement of Facts in which Moodys acknowledged key aspects of its conduct, and a compliance agreement to prevent future violations of law. On October 6, 2017, Jonathan Wall was sentenced to probation and Onochie Aghaegbuna was sentenced to time served related to their roles in RX Limited, a fraudulent Internet pharmacy scheme. OxyElite Pro was recalled in 2013 after being linked by the Food and Drug Administration to a deadly outbreak of serious liver injuries. More than 750 patients in 20 states were diagnosed with a fungal infection after receiving injections of methylprednisolone acetate (MPA) compounded at NECC. Docket Number: 2:20-cr-00188 (C.D. Docket Numbers: 15-cr-20471 (S.D. Sentencing before U.S. District Judge Beth Bloom is set for March 19, 2021, in Miami. Akinyoyenu pleaded guilty on February 27 to a misdemeanor conspiracy count. 1:20-cr-20190 (S.D. D.C. Pharmacist Who Distributed Drugs Without Valid Prescriptions Ordered to Pay $250,000 Criminal FineUnited States v. Akinyoyenu Press Release The decision was the culmination of eight years of litigation and a five-week trial arising out of an investigation by the Federal Trade Commission into Dishs violations of the FTCs Telemarketing Sales Rule. On March 1, 2016, David Romeo pleaded guilty to a an information charging mail fraud and introduction of misbranded food into interstate commerce with an intent to defraud or mislead, both in relation to a scheme in which he directed the sale of diluted and adulterated dietary ingredients and supplements sold by his three companies: Global Nutrients, Stella Labs, and Nutraceuticals International. Robinson pleaded guilty in February 2017 to one count of conspiracy to commit odometer tampering and securities fraud. On October 8, 2019, Angel Armando Adrianzen was charged with conspiracy to commit mail fraud and wire fraud, five counts of wire fraud, five counts of mail fraud, and four counts of extortion in connection with an alleged scheme operated by a transnational criminal organization. Court Permanently Enjoins Mississippi Compounding Pharmacy and Two Individuals from Manufacturing and Distributing Adulterated Drugs United States v. Delta Pharma, Inc., et al. In fact, there are currently no legitimate COVID-19 vaccines in existence. Isomeric manufactures, labels, and distributes sterile drugs, including injectable hormones, injectable corticosteroids, and ophthalmic drops. Arbor Pharmaceuticals v. Cochran, The defendants agreed to settle the case and to be bound by a permanent injunction that requires Wa Heng to cease all food preparation, manufacturing and distribution. Working with her co-conspirator in Jamaica, Palmer recruited a friend in Maryland and deposited most that... 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