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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). On January 27, 2021, U.S. District Judge Raymond P. Moore approved the entry of a deferred prosecution agreement (DPA) between the Department of Justice and Epsilon Data Management, LLC, (Epsilon). The government alleged that Bencosme and the other defendants 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. On November 3, 2016, the CEO and a senior manager of a Long Island, New York, company that fraudulently sold vending machine business opportunities were sentenced to prison. As part of the consent decree, the defendants represented that they no longer engage in sterile compounding. Docket Number: 8:20-cv-1794 (M.D. The defendants were executives of Acclarent, a start-up company that was acquired by Johnson & Johnson in 2010. 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. In June 2018, Canadian citizens Maria Thanos and Philip Lett pleaded guilty in the Eastern District of New York to charges of conspiracy to commit mail fraud for their roles in the operation of the same psychic mail fraud scheme. 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. Pa.). The first complaint was filed against US Stem Cell Clinic, LLC, of Sunrise, Florida, US Stem Cell, Inc., and company officers Kristin Comella and Theodore Gradel. Docket Number: 2:19-cv-00324 (W.D. Some victims lost thousands of dollars. Rossi pleaded guilty in December 2017 to conspiracy to commit mail and wire fraud. The indictment alleges Indivior employees encouraged the misuse of Suboxone through relationships with doctors engaged in illegitimate prescribing, and that they made fraudulent claims about the safety and diversion of the drug. On March 4, 2021, U.S. District Judge William Ray denied Plaintiff Arbor Pharmaceuticals, LLCs motion for a temporary restraining order against the government. Several FDA inspections since 2011 revealed violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations and current Good Manufacturing Practice regulations. Dallal procured the drugs from multiple illegal and unlicensed sources and sold them to co-conspirators without the required pedigree document stating where Dallal had purchased the drugs. Blue Bell Creameries Sentencing Date Set in Listeria Contamination Case, United States v. Blue Bell Creameries Epsilon also agreed to implement significant compliance measures designed to safeguard consumers data. Fla.). District Court Enters Permanent Injunction to Stop New Jersey and New York Companies and Executives from Distributing Unapproved and Misbranded DrugsUnited States v. S Hackett Marketing LLC d/b/a Just Enhance, et al. The defendants instead took the first six months of payments and more as undisclosed up-front fees. Fla.). Both defendants were also sentenced to one year of supervised release following their imprisonment and a $5,000 fine. The complaint alleges that Dr. Tobias Bacaner, Theodore Ferguson II, and Timothy Ferguson used Paragon Community Healthcare Inc., to unlawfully issue controlled substance prescriptions, and Cobalt Pharmacy Inc., to unlawfully fill controlled substance prescriptions, all in violation of the Controlled Substances Act. Before trying a Civil case the judge will read the relevant case papers and becomes familiar with their details. Court Permanently Enjoins New York Company from Distributing Adulterated and Misbranded Dietary SupplementsUnited States v. Riddhi USA, Inc., et al.Press Release 20-CV-4218 (C.D. In pleading guilty, Palso admitted to conspiring to defraud pharmacy benefit managers into paying for fraudulent prescriptions for topical pain creams, vitamins, and other products. In reality, Romeos companies sold Chinese knock-off hoodia that was imported using forged documentation. District Court Enjoins Smoked Fish Manufacturing Company and Several Key Employees from Continuing to Violate the Food, Drug, and Cosmetic Act United States v. New York City Fish, Inc., Maxim Kutsyk, Pavel Roytkov, and Leonid StaroseleteskyPress ReleaseDocket Number: 1:13-CV-2909 (E.D.N.Y.). 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. Long used the proceeds of his fraud scheme to purchase a ranch in Texas, three airplanes, cars, buses, ATVs, and a fire truck, as well as to pay other personal expenses. The government alleged that between 2013 and 2018, the scheme brought in millions of dollars from victims, many of whom were elderly or vulnerable, without paying the promised cash prizes to anyone. On June 5, 2015, the United States filed an injunction action in the District of New Jersey against Acino Products, LLC (Acino) and its owner, Ravi Deshpande, to prevent the distribution of unapproved and misbranded drugs. Many victims received nothing; others received only a cheap piece of jewelry or a report listing unrelated sweepstakes. 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. FDA had previously warned NAE, after inspections performed in 2013 and 2014, of its failures to maintain sanitary conditions. On May 10, 2017, pharmacist Titilayo Akinyoyenu was sentenced to 36 months of probation and ordered to pay a $250,000 criminal fine for his role in a conspiracy to ship pharmaceuticals that were misbranded because they lacked valid prescriptions. 2:18-cr-133 (E.D. The letters falsely claimed recipients had won money or valuable prizes, such as luxury cars. Docket Number: 1:18-CV-1121 (E.D.N.Y). The defendant sells smart home monitoring products and services on commission using a door-to-door sales force. On August 29, 2019, the district court entered a consent decree of permanent injunction against Topway Enterprises, Inc., d/b/a Kazys Gourmet, a Houston, Texas company that processes and distributes ready-to-eat raw fish, and its principals, Jeff Liao, Ying Chen, and Adwin Liao. Victims never received any lottery winnings. The complaint alleged that Neptune prepares, processes, packs, holds and distributes ready-to-eat smoked and salt-cured seafood including pickled herring, smoked steelhead trout, smoked halibut, smoked whitefish, smoked salmon and smoked mackerel. Sentencing for Geissler, Doyle, Patel, and S.K. Gao was the supply chain manager for a Chinese firm that sold raw ingredients for use in dietary supplements. Docket Number: 15-cr-20471 (S.D. The complaints allege that that in some cases, adverse events that harmed patients occurred after treatment with the SVF products, and that recent FDA inspections showed that the defendants products are not manufactured, processed, packed, or held in conformance with current good manufacturing practice (CGMP). In pleading guilty, Parks admitted that, from approximately June 2017 to September 2019, he and his company, MedFitRX, unlawfully distributed selective androgen receptor modulators (SARMs) and other substances that the FDA has not approved, including Ostarine (MK-2866), Ligandrol (LGD-4033), and Testolone (RAD-140). As part of his guilty plea, Hidalgo admitted that he and others at Everglades in Peru called victims in the United States claiming to be attorneys or government representatives. For more information, see the Press Release dated May 1, 2020. The defendant is presumed to be innocent until proven guilty beyond a reasonable doubt in a court of law. Defendant Sentenced in Multi-Million-Dollar Prize Promotion Scams Targeting Elderly Victims United States v. Burke and RossiPress Release Fla.); 5:16-CV-0577 (M.D. Docket Number: 2:18-CR-0031 (E.D.N.Y.). Docket Number: 3:17-CR-546 (N.D. Both the plaintiff and the defendant are also referred to as "parties" or "litigants." Court of Appeals Upholds Civil Penalty and Injunction Against Spectrum Brands for Failure to Report Defective Coffeemaker CarafeUnited States v. Spectrum Brands Press Release Lindo was also ordered to pay $292,900 in restitution. The callers falsely claimed that victims failed to pay for or receive certain product deliveries, and that victims owed thousands of dollars in fines as a result. 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 governments complaint seeks preliminary and permanent injunctions, civil penalties, and other equitable relief. Witness Testimony and Cross-Examination Many of the drugs sold by the defendants were generic drugs that were unapproved for sale in the United States; others were Schedule III steroids or drugs used by steroid users, such as clenbuterol. Docket Numbers: 1:14-cr-75 & 1:12-cr-489. Docket Number: 1:19-CV-3382 (N.D. Ill.). In a complaint filed on May 14, the United States alleged that the defendants, Xephyr LLC (d/b/a N-Ergetics), Brad Brand, Derill Fussell, and Linda Fussell, sold colloidal silver through their website as a treatment for COVID-19 and other diseases and conditions, such as pneumonia, AIDS, and cancer. Fla.). Docket Numbers: 15-cr-20471 (S.D. 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. Defendants in USP Labs Dietary Supplement Scheme Set for Sentencing in July/August 2020United States v. USP Labs, Press Release In October 2020, the court denied MediNaturas first motion for preliminary injunction (which MediNatura appealed) and dismissed MediNaturas claims challenging FDAs addition of its products to the import alert. Smith instructed customers to combine MMS with citric acid and ingest the resulting chlorine dioxide. The insanity conditions included the presence of rodent excrement and mold in the production facility. In the spring of 2007, AM2PAT moved to a new manufacturing facility and changed the company AM2PAT would use to sterilize B. Braun saline syringes through a new radiation sterilization process. 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. 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. 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. 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. The temporary restraining order blocks the defendants from operating the alleged scam and shuts down hundreds of websites used by the defendants to carry out their scheme. Docket Number: 1:19-CR-00016 (W.D. On May 20, 2015, the United States filed a criminal Information against ConAgra Grocery Products LLC, a subsidiary of ConAgra Foods Inc., alleging that the company introduced peanut butter contaminated with salmonella into interstate commerce in 2006. On February 22, 2019, Judge David Carter denied defendants motion to dismiss the United States complaint, finding that statements on websites can constitute drug labeling under the Food, Drug, and Cosmetic Act (FDCA). On February 6, 2019, the district court entered a consent decree of permanent injunction against Raniers Rx Laboratory Inc., d/b/a Raniers Compounding Laboratory, and its owner, Francis H. Ranier. Three men extradited from Peru for overseeing call centers that threatened and defrauded Spanish-speaking consumers in the United States Xu, a Chinese national, was the principal at a Chinese company that regularly supplied ingredients to American dietary supplement makers. 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. 1345 against Elagoon Business Solutions Pvt Ltd., an India-based company. Docket Number: 6:18-CV-0389 (M.D. Mich.). Fourth Circuit Declines to Apply Federal Common Law for Municipal Climate Change Lawsuit. 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. Mich.). 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. A trial date has not yet been set. Docket Number: 2:16-cr-71 (D. Nev.). The Process He also hid evidence from FDA inspectors and destroyed evidence while law enforcement agents were executing search warrants on his residence and business locations. On August 20, 2018, the United States filed a civil complaint for permanent injunction against Foo Yuan Food Products Company, Inc., its owner and president Hsing Chang, and its secretary Susan Chang. Yabe pled guilty to one misdemeanor violation of the Federal Food, Drug, and Cosmetic Act. The government also alleged that as part of an FDA inspection of UM Research in 2017, Palacio made a signed statement to the FDA in which she knowingly and falsely claimed that a particular clinical trial subject had participated in the trial when in fact that subject had not so participated. Docket Number: 2:18-CV-283 (D. Nev.). 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. Fla.). 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. Several inspections of the firms facility between 2012 and 2014 revealed numerous violations of FDAs 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. Fla.); 5:16-CV-0577 (M.D. In affirming the district courts decision, the Court of Appeals held that the statute of limitations for such a violation does not begin to run until a company finally files the required report, and that the Act allows courts to impose forward-looking injunctive relief. Tex.). A plaintiff who is unable to pay the fee may file a request to proceed in forma pauperis. Contrary to these agreements, Turner sold the drugs to drug wholesalers at higher prices. Fraudulent Call Center Operator Pleads Guilty to Overseeing Call Centers that Threatened and Defrauded Spanish-Speaking Consumers. Docket Number: 3:19-CV-1055 (N.D. View more updates. On November 4, the United States filed an injunction action against Scilabs and Edalat seeking this relief. 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 3, 2020, U.S. District Judge Kathleen M. Williams granted the governments motion for default judgment against two Americans currently located in Colombia who lead the non-religious Genesis II Church of Health and Healing, in an FDCA civil enforcement action. The complaint further alleges that the pharmacies dispensing of opioids has been tied to the deaths of at least two people, and that numerous other individuals have been treated at hospitals for serious overdoses. On July 20, 2016, a federal jury returned guilty verdicts against William Facteau and Patrick Fabian for distributing a medical device known as the Relieva Stratus Microflow Spacer (Stratus). Fla.). Olympus was ordered to pay $85 million in criminal fines and forfeiture, and also agreed to enact extensive compliance reforms. Mo.). The complaint alleged that the defendants marketed such products as drugs to treat serious conditions without FDA approval and without proof of safety and efficacy. Robert Larry Lytle, 84, of Rapid City, South Dakota is currently serving a 12-year prison sentence after pleading guilty last year to introducing misbranded medical devices into interstate commerce with the intent to defraud and mislead and criminal contempt. The businessman said he borrowed his wife's. judgment in a civil action. Tenn.). 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. 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. Evidence at trial showed PCA products sickened hundreds and likely thousands of people during an outbreak of salmonellosis in 2008-09. The Food and Drug Administration cleared LC Bead to be used for embolization, a process in which the flow of blood to liver tumors is stopped or reduced. Case Class: Sentencing is set for April 20 in Miami. The defendants manufacture and distribute several varieties of Italian cheeses such as ricotta, provolone, mozzarella, and primo sale. The defendants also sell background reports despite failing to comply with the laws requiring defendants to ensure that the reports are as accurate as possible, to identify who is buying the reports and how they plan to use them, and to notify buyers of how they may legally use the reports. Docket Number: 18-CR-260, 18-CR-261, 18-CR-578 (E.D.N.Y.). ); 2:15-CV-8889 (C.D. Some were relatively short lived and no longer exist, some were absorbed into other courts, while others still continue. A .gov website belongs to an official government organization in the United States. Press Release Defendant Pleads Guilty in Vending Machine Business Opportunity Case United States v. Kevin M. Marks, Docket Number: 2:16-CR-068 (E.D.N.Y.)(SJF). A civil lawsuit is filed in a civil court. 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. Smith was convicted on May 27, 2015, on charges of conspiracy, smuggling, distributing misbranded drugs, and defrauding the United States, following a seven-day jury trial. Tex.). Mich.), Court Enters Injunction Against Seafood Manufacturer in California. Tenn.). Docket Number: 3:17-CV-04911 (D.N.J). The complaint further alleged that the defendants have grossed at least $10 million over the course of the scheme. The money laundering was in connection with an international lottery fraud scheme involving co-conspirators in Florida and Jamaica. The government presented evidence, collected over nearly a decade, that the defendants violated current good manufacturing practice regulations by, among other things, failing to ensure that finished batches met specifications or to conduct appropriate tests to verify the identity of ingredients. NameCheap, Inc., the company that registered the fraudulent website on the defendants behalf, took down the site within hours of receiving the TRO entered by U.S. District Judge Robert Pitman. Cal.). Docket Number: 1:20-cv-21601 (S.D. According to the complaint, FDA inspections documented significant deficiencies relating to cleanliness and hygienic practices to protect against food contamination, causing the defendants products to be adulterated under the law. A civil case usually begins when one person or business (the "plaintiff") claims to have been harmed by the actions of another person or business (the "defendant") and asks the court for relief by filing a "complaint" and starting a court case. On March 6, 2019, the court unsealed the guilty pleas of two defendants as well as an 18-count indictment against a third individual alleged to have operated a massive mail-fraud scheme for more than 20 years. The complaints were filed by the U.S. Attorneys Office for the Northern District of Ohio and the Consumer Protection Branch. 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. Ohio), Docket Number: 1:15-CR-0024-WLS-TQL (M.D. Sitesh Patel, the vice president of S.K. The terms of the permanent injunction and appropriate civil penalty amount will be decided by the court. On Jan. 30, 2018, Aegerion Pharmaceuticals Inc. (Aegerion) pleaded guilty to violating the Food, Drug, and Cosmetic Act (FDCA) relating to its distribution of a prescription drug, Juxtapid, and was sentenced to three years of probation, to include the establishment of a $7.2 million restitution fund. 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. Podesta and Polo admitted that they managed and supervised call centers for the scheme. Victims of the scheme received telephone calls about substantial lottery prizes they supposedly had won. The firms products were also found to be misbranded as the labels of the ready-to-eat soups failed to list all of the soups ingredients and failed to declare major food allergens. Between July 2011 and November 2012, Baxter manufactured IV solutions in a clean room with moldy HEPA filters, despite the fact that an employee had reported the presence of mold on the HEPA filters to plant management. Medical Doctor Pleads Guilty in Clinical Trial Fraud Scheme. Delaware Cheese Company Pleads Guilty to Food Adulteration Charge; Company and Individuals Also Enter Consent DecreeUnitedStates v. Roos Foods, Inc. Press ReleaseDocket Number: 1:16-MJ-0013(D. FDA testing on samples of the gel tested positive for bacterial contamination. FDA inspectors also found deviations from current good manufacturing practice requirements in the pharmacys sterile drug manufacturing operations. Firm that sold raw ingredients for use in dietary supplements extensive compliance reforms,. 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To drug wholesalers at higher prices of Acclarent, a start-up company that was acquired by Johnson Johnson... Call Center Operator Pleads guilty to one misdemeanor violation of the consent decree, the States... 2014, of its failures to maintain sanitary conditions by Johnson & Johnson in.. Current good manufacturing practice requirements in the pharmacys sterile drug manufacturing operations to an government... Current good manufacturing practice requirements in the pharmacys sterile drug manufacturing operations filed a! Payments and more as undisclosed up-front fees Municipal Climate Change Lawsuit unrelated sweepstakes undisclosed!

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