According to the complaint, a 2016 FDA inspection of the defendants manufacturing facility also revealed that the defendants failed to establish specifications for the identity, purity, strength, and composition of their finished products or the components in their products. California Man Pleads Guilty to Possession of Child Pornography, United States v. Adrianzen The complaints alleged that the defendants imported childrens products containing, among other things, lead, phthalates, and small parts that posed a choking hazard for children under the age of three. Many victims made monetary payments based on these threats. Sentencing for USP Labs and SK Labs is set for July 14, 2020. On Feb. 20, 2018, the district court issued a temporary restraining order pursuant to 18 U.S.C. Over the centuries many civil courts were created to deal with different branches of the law. The Court found that given the egregiousness, seriousness, and willfulness of defendants past violations, coupled with their dubious promises of reform, a permanent injunction is necessary to prevent a substantial likelihood that defendants will violate the Act in the future. The complaint alleged the schemes targeted the elderly and generated approximately $4.8 million in annual victim losses. On June 30, 2015, former Quality Egg marketing manager Tony Wasmund was sentenced to four years probation for his participation in a conspiracy to bribe a USDA Inspector, to sell restricted eggs with intent to defraud, and to introduce misbranded food into interstate commerce with intent to defraud and mislead regulators and customers. United States v. Castro et al. In addition, the company is paying $25 million to resolve civil allegations under the False Claims Act. Weaver argued in his appeal that he was not guilty because Vendstar customers signed purchase agreements in which they disclaimed reliance on what sales representatives had said verbally. On June 1, 2020, U.S. District Judge Robert N. Scola sentenced Francesco Guerra to 90 months imprisonment and three years of supervised release for his supervision of a Peruvian call center used to carry out a fraud and extortion scheme against American consumers. Among other requirements, the defendants must establish and implement procedures to ensure a thorough investigation of any unexplained discrepancy or failure in a drug batch, regardless of whether the batch has been distributed. Docket Number: 1:17-CV-0033-MSK-MJW (D. Colo.). The court set a sentencing date of August 3, 2021. 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. South Dakota Man Pleads Guilty in QLasers Medical Device ScamUnited States v. Ronald D. Weir, Jr. Press Release The governments complaint alleges that the defendants illegally market their Zylast hand sanitizer products as unapproved new drugs intended to fight various specific pathogens, such as Ebola. Docket Number: 2:14-CV-14450 (E.D. As set out in the Departments complaint, which was filed concurrently with the proposed joint Consent Decree on March 10, the defendants manufactured and distributed dietary supplement products as drugs that could help treat or prevent a host of serious conditions, including heart disease, diabetes, depression, hypertension, osteoporosis, and liver and kidney disorders. On January 28, 2021, U.S. District Judge Edward R. Korman granted the governments motion for summary judgment in a case seeking a permanent injunction against New York dietary supplement firm Confidence USA and its operators for continued alleged violations of the Food, Drug, and Cosmetic Act. 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 animals genome as a new animal drug. On March 27, 2018, the district court permanently enjoined dietary supplement distributor MyNicNaxs LLC, and two principals of the company, Chevonne Torres and Michael Banner, from selling and distributing unapproved and misbranded new drugs. Additionally, Lytles longtime live-in companion, Fredretta L. Eason, was charged with aiding and abetting Lytles criminal contempt. Victims never received any lottery winnings. The callers claimed that victims owed thousands of dollars in fines, and threatened victims with supposed court proceedings, negative marks on credit reports, imprisonment, and deportation. 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. 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. Docket No. View more updates. Fla.). 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. 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 companys plant in Sylvester, Georgia. In its motion to dismiss, Indivior asserted that prosecutors engaged in misconduct before the grand jury related to a reference in the indictment to a doctor who had been charged with healthcare fraud unrelated to Suboxone. In addition to manufacturing and distributing products under the name Henh Wong Fresh Produce, the firm also manufactures and distributes products as Henh Wong Fresh Product and Henh Wong Tofu. On July 12, 2016, the government filed criminal informations against two individuals, charging each with one misdemeanor count of introducing an unapproved new drug into interstate commerce in violation of the federal Food, Drug and Cosmetic Act (FDCA). Share sensitive information only on official, secure websites. United States v. WeCare Pharmacy, et al. Quaglia and Fraser each were charged with several counts of mail fraud and conspiracy to commit mail fraud in connection with deceptive mass mailings that falsely promised large cash prizes in exchange for the payment of fees. The conflict started with an Amazon contract. Tex.). Victims never received any lottery winnings. These lots of drugs were not distributed into interstate commerce. Defendants products, which included 4NOx2, HGH Night Time, rHGH Drops Black Label, Primal Rage Levo 5 GH Mass and Deer Antler Velvet Extract, were not approved by the FDA. Based on the evidence presented, the court found probable cause to conclude that Defendant Maven Infotech Pvt. (respectively). The Indictment also charged Lytle with obstruction of FDA proceedings. 1345 against six individuals and fourteen corporate entities alleged to have operated a mass-mailing scheme based in Las Vegas, Nevada. Fla.). A civil lawsuit can arise in many different areas of law and often concerns the recovery of money or property. U.S. Supreme Court Issues Landmark Civil Rights Decision Bostock v. Clayton County, 590 U.S. (2020) 1. In all, 22 individuals were convicted of fraud in connection with Vendstar. Based on the evidence presented, the court found probable cause to conclude that the defendants engaged in a widespread pattern of telecommunications fraud, intended to deprive call recipients in the Eastern District of New York and elsewhere of money and property. Among other provisions, the injunction bars defendants from carrying any VoIP calls destined for phones in the United States and from providing any U.S. telephone numbers (often used as call-back numbers in the fraudulent robocalling schemes) to any individuals or entities during the pendency of the litigation. In fact, the victim did not win the lottery and never received any winnings. Smith received the money, kept a portion for herself, and sent the remainder to individuals in Jamaica. Fla.). According to the complaint, the defendants all played roles in the schemes, which involved solicitations claiming victims had won large cash prizes. At a plant in North Carolina, Baxter manufactured large-volume sterile intravenous (IV) solutions in a clean room that had high-efficiency particulate absorption (HEPA) filters installed in the ceiling. Restitution will be decided at a later hearing. Defendants in a civil case don't have the right to an . The complaint alleged that testing by the defendants revealed a type of listeria in the Vulto facility, but the defendants never attempted to identify the species of the bacteria or its source. United States v. Omar Cuzcano Marroquin, et al., Case No. Court Denies Drug Companys Motion for Emergency Relief in Case Involving Challenge to FDAs Drug Withdrawal Determination. and United States v. California Stem Cell Treatment Center, Inc., et al.Press Release Evidence at trial showed PCA products sickened hundreds and likely thousands of people during an outbreak of salmonellosis in 2008-09. This action stems from a series of FDA inspections of APS manufacturing facility beginning in 2012, which revealed, among other things, that APS failed to perform identity tests or examinations for certain dietary ingredients before using them in their products. Arnold v. According to the complaint, the defendants issued thousands of prescriptions without apparent regard for patient harm, including prescriptions for a dangerous combination of an opioid, short-acting benzodiazepine, and a muscle relaxer. 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. Sales staff routinely lied to homeowners, stating that the firms had a team of experienced attorneys, a long track record and a very high success rate. FDA inspections performed in 2013 and 2014 documented a pattern of insanitary conditions resulting in the presence of Listeria monocytogenes. On June 24, the district court entered a consent decree of permanent injunction against Wa Heng Dou-Fu & Soy Sauce Corporation and the firms co-owners, Peng Xiang Lin and Yuexiao Lin, to prevent the distribution of adulterated and misbranded soy products. The injunction permanently enjoins the defendants from distributing misbranded and adulterated medicated animal feed in violation of the Food, Drug, and Cosmetic Act, and requires the defendants to cease manufacturing medicated animal feed until they take certain remedial actions. Long charged the accounts of more than 100,000 prior customers of these merchants who had not agreed to any new charges by Longs company. Before it, Gerald Groff had been happy with his work as a rural mail carrier and happy to be able to have Sundays off. Injunctions Entered Against Defendants in Multi-Million Dollar International Mail Fraud SchemeUnited States v. BDK Mailing GmbH, et al.Press Release 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. Both defendants were charged in a 14-count indictment alleging a five-year identity theft scheme that targeted servicemembers and veterans. 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. View Complaint. Docket Number: 2:20-cv-10032 (E.D. Individuals, organizations, and businesses involved in lawsuits fall under civil law cases. Raventos is the first of the four charged defendants to plead guilty. 1:20-cv-02066 (D.D.C.). Press Release On March 24, 2020, U.S. District Judge Robert N. Scola sentenced Rodolfo Hermoza to serve 88 months imprisonment in connection with his supervision of call centers in Peru that threatened American consumers into paying fraudulent settlements for nonexistent debts. Court Rules in Favor of Government in Challenge to FDA Guidance Document Lystn, LLC, d/b/a Answers Pet Food v. FDA, et al. The dealers, in turn, sold them to consumers. District Court Rules for Government in Action Against Cheese Manufacturer United States v. S. Serra Cheese Co., Fina Serra, and Stefano Serra, Press ReleaseDocket Number: 2:14-CV-13077 (E.D. Civil cases do allow juries in some instances, but many civil cases will be decided by a judge alone in what is referred to as a bench trial. Sentencing is set for April 6, 2020. Many homeowners lost their homes to foreclosure after hiring the firms. 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. Laboratories pleaded guilty to introduction of misbranded food into interstate commerce, and USPlabs pleaded guilty to conspiracy to introduce misbranded food into interstate commerce. The civil penalties include $168 million payable to the United States related to at least 66 million illegal calls by Dish and its retailers. People typically sue to make up for some sort of loss or injury they've suffered. Nevada Woman Pleads Guilty in Multi-Million-Dollar Prize Notification Scam Affecting Elderly Victims United States v. Burrow Docket Number: 6:20-cv-140 (E.D. One of his co-defendants will be sentenced in April, and another co-defendant is set for trial later this spring. Both men pleaded guilty in March 2016 to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act (FDCA). Oshiro has an extensive history of growing, processing, and packaging ready-to-eat mung bean, alfalfa, clover, and radish sprouts under grossly insanitary conditions. Okla.). Edward Morris Ned Weaver, who was Vendstars president and CEO from 2004-2010, was sentenced to 60 months in prison. Former Auto Body Shop Owner Sentenced for Role in Odometer and Title Fraud SchemeUnited States v. Paul RobinsonPress Release Chipotle Mexican Grill to Pay $25 Million Fine for Food Safety Violations, United States v. Chipotle Mexican Grill, Inc.Press release Docket Number: 2:19-cr-295 (D. Nev.). 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. 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. The court previously entered a default judgment against the entity and two principals located in the United States. The court sentenced Gutierrez to 51 months imprisonment, and Podesta and Polo to 46 months imprisonment. The company severed ties with Pedersen and agreed to cooperate in his prosecution. Court Permanently Enjoins Mississippi Compounding Pharmacy and Two Individuals from Manufacturing and Distributing Adulterated Drugs United States v. Delta Pharma, Inc., 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 Dailey was the owner and operator of Nomad Botanicals, an online business that sold kratom to consumers throughout the United States. Among other violations of federal law, the defendants made claims about many of their products that rendered the products drugs under the Food, Drug, and Cosmetic Act. On December 20, 2018, Zhang Xiao Dong (aka Mark Zhang), a Chinese citizen, was sentenced to 24 months imprisonment in connection with a fraud and smuggling scheme to sell mislabeled dietary supplements containing hidden synthetic stimulants. The indictment, returned on February 23, 2021, alleges that the defendants enrolled subjects into clinical trials who did not meet the eligibility criteria for those trials, falsified laboratory results, falsified medical records, and falsely represented that subjects were taking the drugs being studied when in fact they were not. 18-1785 (7th Cir.) Among other things, Raventos admitted that she falsely represented in medical records that pediatric subjects were participating in the trial when, in fact, they were not participating or taking the study medication. Docket No. Wall previously pleaded guilty to one count of conspiracy to violate the Federal Food, Drug, and Cosmetic Act (FDCA). 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. Ga.), District Court Rules for Government in Action Against Cheese Manufacturer, Docket Number: 2:14-CV-13077 (E.D. In pleading guilty, Wall admitted that beginning in 2007, he managed a call center in Manila associated with RX Limiteds online pharmaceutical sales websites. 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 permanent injunction entered by the court prohibits the defendants from selling any products until they hire experts to bring their labeling, recordkeeping, and other practices into compliance with federal law. 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. Through a separate company that it contracted with to market and distribute LC Bead in the United States, Biocompatibles marketed LC Bead to deliver chemotherapy drugs a use that was never cleared or approved by the FDA. Bethel sold a wide variety of dietary supplements. Calif.). Along with pleading guilty, the company agreed to pay a criminal fine of $30 million and forfeit an additional $20 million. Docket Number: 2:20-cv-279 (D. Utah). 2:19-cv-3073 (E.D.N.Y.). (Joel) Frantzman, to prevent the distribution of adulterated seafood products. Jesus Gutierrez Rojas, Alexandra Podesta Bengoa, and Virgilio Polo Davila pleaded guilty to extortion following their extradition from Peru in April. 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. Docket Number: 1:19-cv-2184 (D.D.C.). Docket No. FDA inspections and other evidence showed a repeated failure of Serra Cheese to reduce the risk of contamination from bacteria and to undertake critical measures that are essential to prevent the growth of certain potentially dangerous bacteria such as Listeria and E. coli, including failing to adequately clean and sanitize equipment in a proper manner. Sentencing before U.S. District Judge Beth Bloom is set for April 16, 2021, in Miami. The complaint, filed with the consent decree on Dec. 18, 2017, alleged that until 2012, Dr. Reddys distributed oral prescription drugs in blister packaging that it failed to test for child resistance under the Poison Prevention Packaging Act. B. Braun Medical Inc. Agrees to Resolve Criminal Liability for its Sale of Contaminated SyringesUnited States v. B. Braun Press Release. If the party who filed the lawsuit is successful in court, the other party may be ordered to pay monetary damages, or he may gain some other advantage. Court Enters Preliminary Injunction in Case Involving Silver Products Touted as a COVID-19 Treatment, United States v. Xephyr LLC, et al. 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. Eubank, who operated an automobile electronics repair shop in Midlothian, Virginia, acknowledged that between 2010 and 2016, he used various electronic tools to access motor vehicle odometers to lower the odometer readings of hundreds of vehicles. For other matters of interest, see: CLOSED CASES or ARCHIVED CASE SUMMARIES. 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). Smith was also ordered to pay $724,408.79 in restitution. Docket Number: 1:18-CV-04689-ENV-CLP (E.D.N.Y.). In a complaint filed on March 14, the United States alleged that the Florida company sold sexual enhancement and weight loss products in violation of the Federal Food, Drug, and Cosmetic Act. 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 19-cv-06589 (E.D.N.Y.). For example in the summer of 2014, inspectors found that 19 lots of Downings drugs had tested positive for various microorganisms, including Staphylococcus haemolyticus, which can cause septicemia, peritonitis, and urinary tract infections, and Nocardia nova, which can cause pneumonia, sinusitis, and skin infections. According to an indictment returned in October 2017, Zhang and two co-defendants agreed with a confidential government informant to either mislabel synthetic stimulants such as 1,4-DMAA or otherwise help to hide the true nature of a proposed dietary supplement from retailers. Lindo was also ordered to pay $292,900 in restitution. 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. 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. Press Release The United States complaint, filed in September 2016, alleges that the defendants ran an international mail fraud scheme that sent millions of multi-piece solicitations to potential victims throughout the United States that professed to come from financial entities, scholars, and world-renowned psychics. Former Virginia Physician Pleads Guilty to Conspiracy to Violate the Controlled Substances Act and Food, Drug, and Cosmetics Act Related to Internet Pharmacy OperationUnited States v. Ryan, Press release growth and toxin formation in susceptible fish and fishery products. United States Seeks Preliminary Injunction Against Arkansas Compounding PharmacyUnited States v. Cantrell Drug Co. et al.Press Release On May 25, 2016, the Department of Justice secured a civil jury verdict in Salt Lake City, Utah, against Utah-based telemarketing defendants Feature Films for Families, Inc., Corporations for Character, L.C., Family Films of Utah, Inc., and Forrest S. Baker III. Press Release The injunction requires the defendants to hire a sanitation expert, develop a written pathogen control and monitoring program, and retain a qualified independent laboratory to gather and analyze environmental samples from Serra Cheeses facility. 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. Calif.). Court Denies Indiviors Motion to Dismiss Indictment in Suboxone Case, United States v. Indivior, Inc. Docket Numbers: 1:20-cv-00306-RP (W.D. Press Release 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. Montana Man Pleads Guilty for Designing Fraudulent Solicitations as Part of Large-Scale International Mass-Mailing Fraud Scheme United States v. Thomas Ressler 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 A preliminary injunction hearing is scheduled for December 3, 2018. Court Enters Permanent Injunction and Civil Penalty Against Utah Telemarketers United States v. Feature Films for Families, Inc., et al.Press Release Frappier was in charge of PacNets Marketing and Client Services departments, and Kelly oversaw PacNets Compliance Department. The callers also falsely threatened victims with court proceedings, negative marks on their credit reports, imprisonment, or immigration consequences if they did not immediately pay for the purportedly delivered products and settlement fees. Docket Number: 3:16-CR-0224 (W.D.N.C.). The Court found that Dish and various retailers the company hired to market its products and services made millions of telemarketing calls to phone numbers on the National Do-Not-Call Registry, calls to persons who asked sellers not to call them, and illegal robocalls. Contact the Webmaster to submit comments. The Statement of Facts addresses Moodys representations to investors and the public generally about: (1) its objectivity and independence; (2) its management of conflicts of interest; (3) its compliance with its own stated RMBS and CDO rating methodologies and standards; and (4) the analytic integrity of certain rating methodologies. Fla.). This case presents the following issues: (1) Is a grant of In pleading guilty, Long admitted that he used personal and financial information of more than 375,000 victims to steal millions of dollars from checking accounts. On April 21, 2020, the Department of Justice announced that Chipotle Mexican Grill had agreed to pay a $25 million fine to resolve criminal charges related to foodborne illness outbreaks that sickened more than 1,100 people between 2015 and 2018. Cal.). 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Charged with aiding and abetting Lytles criminal contempt resolve criminal Liability for its Sale of Contaminated States! And Cosmetic Act ( FDCA ) four charged defendants to plead guilty of his will!
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