On March 30, 2018, the district court permanently enjoined a Walton, New York, creamery and its owner, Johannes Vulto, from manufacturing and distributing adulterated food. NECC was the source of contaminated drugs that spawned the 2012 nationwide fungal meningitis outbreak, the largest public health crisis ever caused by a pharmaceutical product. In particular, the court found that because hydroxychloroquine remains an FDA-approved and commercially available drug, physicians are free to prescribe it, and any objections by state medical boards to the use of hydroxychloroquine to treat COVID-19 are not traceable to FDA or HHS. The Fourth Circuit recently held that it did, joining two other appellate courts and worsening an existent circuit split. District Court Permanently Enjoins 15 Individuals and Companies in Elder Fraud Mail Scheme On March 31, 2014, the U.S. District Court for the Eastern District of New York entered an injunction against New York City Fish, Inc., a manufacturer of ready-to-eat fishery products, including smoked salmon and mackerel, and three of its employees: Maxim Kutsyk, Pavel Roytkov, and Leonid Staroseletesky. Docket Number: 2:19-CV-9 (M.D. 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. Clenbuterol is only approved for sale in the United States as an equine bronchodilator, yet is sold on the black market for use by bodybuilders. Docket Number: 1:16-CR-0021 (S.D. 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. The defendants were arrested in 2016 by Peruvian authorities and extradited to Miami in December. For more information about this case and any further updates, please see this page. Victims sent such fees to Shaw, who then forwarded a portion of the money to Jamaica. The complaint alleged that ABH and Islam manufactured and distributed dietary supplements under conditions that failed to comply with current good manufacturing practice regulations. District Court Enters Permanent Injunctions Against Two New York Companies Banning the Importation of Dangerous ToysUnited States v. Everbright Trading, Inc. et al. From 2005 to 2012, the websites operated by Ul Haq and his co-defendant Tahir Saeed illegally sold $2 million worth of prescription drugs, including anabolic steroids and other controlled substances, to customers worldwide, including nearly $780,000 in sales to United States purchasers. The indictment alleges that Reyes purchased and received at his home counterfeit THC vaping products from China. According to the information, Bencosme and her co-conspiratorsincluding Bencosmes medical practice receptionist, Maytee Lledo, and two UM Research study coordinators, Jessica Palacio and Lisett Raventosfabricated 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. MediNatura v. FDA, Trial for the remaining defendants is set for July 13, 2021. 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. Va.) United States v. Omar Cuzcano Marroquin, et al., Case No. Find Sports Law Case Summaries at FindLaw. In a civil lawsuit, it is usually the individual that has brought the case to the attention of the court and initiated litigation. According to the complaint, the defendants all played roles in the schemes, which involved solicitations claiming victims had won large cash prizes. As part of Juxtapids approval, FDA required a Risk Evaluation and Mitigation Strategy (REMS) to educate prescribers about the risks of liver toxicity and to restrict access to Juxtapid only to those patients with a clinical or laboratory diagnosis consistent with HoFH. 8:21-cv-00391 (M.D. Link Copied! For example, here's how Justice Goldberg (a federal appeals court judge in Texas) began his 1986 opinion in. On May 6, 2016, the district court approved a consent decree resolving the claims against all remaining defendants in this civil action for injunction pursuant to 18 U.S.C. Rosanne Day, Robert Paul Davis, Genevieve Renee Frappier, and Miles Kelly each were charged in the District of Nevada with one count of conspiracy to commit mail and wire fraud, one count of conspiracy to commit money laundering, and multiple counts of mail fraud and wire fraud. After numerous warnings in 2013, 2014 and 2015, NAE has still failed to take adequate steps to improve its manufacturing practices of its ready-to-eat refried beans and sauces. In many letters, Gore used a false name, claimed to be the Director/Legal Services-Collections, and threatened that lawyers would pursue legal proceedings against victims. After these infections, all of B. Brauns syringes manufactured by AM2PAT were recalled. New Jersey Man Pleads Guilty to Large-Scale International Mass-Mailing Fraud SchemeUnited States v. Ercan Barka 1345 against Elagoon Business Solutions Pvt Ltd., an India-based company. Injunction Entered Against Eight Individuals and Entities That Ran Psychic Mail Fraud Scheme United States v. Metro Data Management, et al. Mich.). These lots of drugs were not distributed into interstate commerce. In fact, there are currently no legitimate COVID-19 vaccines in existence. Robinson and his co-conspirators then acquired Virginia motor vehicle titles with false, low-mileage odometer readings, which were used to sell the vehicles to unsuspecting purchasers. The $36 million global resolution relates to the medical device LC Bead, which is used to treat liver cancer. Biocompatibles was sentenced to pay an $8.75 million criminal fine and a criminal forfeiture of $2.25 million. 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. The injunctions resolve two separate civil actions filed by the Department on June 21 at the request of the U.S. Consumer Product Safety Commission (CPSC). Del.) The defendants manufacture and distribute several varieties of Italian cheeses such as ricotta, provolone, mozzarella, and primo sale. Lead NECC Defendant Sentenced to Nine Years in Prison in Connection with 2012 Nationwide Fungal Meningitis OutbreakUnited States v. Barry CaddenPress Release Va.). The websites were linked to RX Limited, a large Internet pharmacy operation that shipped orders with no face-to-face physician contact and allowed customers themselves to choose the type, strength, and quantity of drugs they ordered. The consent decree subjects the defendants to heightened FDA oversight and requires them to cease all operations until the defendants implement a number of new record-keeping and operational protocols designed to ensure consumer safety. The criminal charges will be dismissed in three years if Pentax complies with enhanced compliance requirements that are part of the agreement. The court asked the government to submit a proposed permanent injunction and has scheduled a conference for the parties to discuss the content of that injunction. Five other defendants Mario Castro, Jose Salud Castro, Salvador Castro, Miguel Castro, and Jose Luis Mendez are awaiting trial, which likely will be scheduled for May 2021. The district court entered the proposed consent decree. The callers also falsely threatened victims with lawsuits, negative marks on their credit reports, imprisonment, or immigration consequences if they did not immediately pay for the purportedly delivered products and settlement fees. A civil court is a court of law that handles various types of civil cases. Court of Appeals Affirms Convictions and Sentences for Peanut Corporation of America Salmonella-Outbreak DefendantsUnited States v. Stewart Parnell, Michael Parnell, and Mary Wilkerson The complaint seeks civil penalties as well as a preliminary and permanent injunctive relief against the defendants. Miss.). On December 23, 2019, the U.S. District Court for the Eastern District of New York permanently enjoined Edgewood, New York entities ABH Natures Products, Inc., ABH Pharma, Inc., and StockNutra.com, Inc., along with the businesses owner, Mohammed Jahirul Islam, of Flushing, New York, from distributing adulterated and misbranded dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act. The callers told victims they had failed to pay for or receive a delivery of products, and claimed that victims faced court proceedings and owed thousands of dollars in fines. 1345 against two Scottsdale, Arizona-based voice-over-internet-protocol (VoIP) carriers, Ecommerce National LLC d/b/a TollFreeDeals.com and SIP Retail d/b/a sipretail.com, and their owner/operators Nicholas and Natasha Palumbo. Before closing in July 2010, Vendstar made approximately $10 million to $12 million in sales per year. Tex.). On March 15, 2021, U.S. District Judge James P. Jones sentenced Brett Becker to six months of home confinement for introducing unapproved new drugs into interstate commerce in violation of the Food, Drug, and Cosmetic Act. Cuzcano admitted that he managed and supervised call centers that were operated as part of the scheme in which the defendants and their employees falsely claimed to be lawyers, court officials, federal agents, and representatives of a supposed minor crimes court. According to court documents, Cuzcano and his co-conspirators falsely told victims that they had a contractual obligation to pay for and receive products and had caused legal problems for themselves and others by allegedly failing to do so. Bostock v. Clayton County, 590 U.S. (2020) The Supreme Court has issued a landmark decision in Bostock v. Clayton County, holding that . According to charges, Gore sent collection letters to victims of the psychic scheme after the victims checks bounced. 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). Basnight pleaded guilty in January to one count of conspiracy to commit odometer tamping and securities fraud. According to the complaint, consumers pay for items supposedly sold through the websites but never receive those purchases. 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. Palsos guilty plea follows pleas by co-conspirators Larry Smith, Mihir Taneja, Arun Kapoor, Maikel Bolos, and Sterling-Knight Pharmaceuticals in December 2020 and January 2021. Cuzcano is the first of five defendants in the case to plead guilty. 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. 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 U.S. District Judge Robert N. Scola sentenced one of Guerras co-defendants to 88 months imprisonment in March. 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. On June 23, 2020, Gareth David Long, of Las Vegas, Nevada, was sentenced to serve 70 months in prison for stealing millions of dollars from hundreds of thousands of consumers. 4:21-cv-00437-RLW (E.D. On February 17, 2017, Felecia Roxanne Lindo was sentenced to serve 24 months in prison and three years supervised release for her role in a fraudulent lottery scheme based in Jamaica. On September 15, 2020, the district court entered a consent decree of permanent injunction against Fortune Food Product, Inc., company president Steven Seeto, and supervisor Tiffany Jiang. Docket Number: 2:19-cr-295 (D. Nev.). 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. He was arrested in Liberia and expelled to the United States in September 2012. However, as of early 2017, the defendant had not brought any purchase offers to the court, and he continued to owe more than $2.8 million. PCA president Stewart Parnell, sales manager Michael Parnell, and quality assurance director Mary Wilkerson all were convicted in September 2014 and sentenced to 336 months, 240 months, and 60 months of imprisonment, respectively. where three individual plaintiffs sue one defendant, or one plaintiff sues two separate defendants), attorneys representing each party may give their own distinct opening arguments. 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. The Courts order prohibits the defendants from continuing to manufacture or distribute their products unless and until they come into compliance with the law. Docket Number: 2:17-CV-14038 (S.D. Defendants Foreign Properties Sold for $1,665,000 To Obtain Restitution for Fraud VictimsUnited States v. Shevin Goodman The temporary restraining order proposed by the United States would block the defendants from operating the alleged scam and shut down hundreds of websites used by the defendants to carry out their scheme. Smith previously pleaded guilty to one count of conspiracy to commit mail and wire fraud. 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 The defendants conspired to smuggle at least 43 known shipments, totaling approximately 106,000 pills, from China to Texas. Calif.). Cooperating Defendant Sentenced in Egg Contamination CaseUnited States v. Tony WasmundPress ReleaseDocket Number: 3:12-CR-3041 (N.D. Iowa). A hearing for entry of a plea and sentencing is scheduled for May 21, 2018. Docket Number: 3:17-CR-547 (N.D. The consent decrees permanently enjoin the defendants from using the U.S. Mail to distribute fraudulent mailings or any mailings promoting similar schemes. The complaint alleged the schemes targeted the elderly and generated approximately $4.8 million in annual victim losses. L. mono is food-borne bacteria that can cause serious illness or even death in consumers. The defendant sells smart home monitoring products and services on commission using a door-to-door sales force. 1345 against Maven Infotech Pvt. Less than a month after B. Braun resumed buying syringes from AM2PAT, AM2PAT manufactured B. Braun saline syringes contaminated with Serratia marcescens bacteria. Docket Number: 2:14-cr-126 (E.D. Hermoza and the other callers told victims that they must immediately pay settlement fees to avoid these consequences. Docket Number: 3:16-CR-313-RJC (W.D.N.C.). Press Release Dailey pleaded guilty on January 8, 2019 to one count of introducing misbranded drugs into interstate commerce and one count of importing merchandise contrary to law. Cal.). United States v. Kafeiti, et al. 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. Two Mississippi Men Sentenced in Odometer Fraud SchemeUnited States v. Baine; United States v. Savarese, Press Release Olympus was ordered to pay $85 million in criminal fines and forfeiture, and also agreed to enact extensive compliance reforms. 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. As part of his plea, Dailey agreed to forfeit $1,000,000 in illegal proceeds. 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 filed a complaint alleging that the companys dietary supplements are manufactured under conditions that are inadequate to ensure the quality of its products. Complaint Filed Against New York Food Distributors Alleging Insanitary ConditionsUnited States v. Euroline Foods, LLC, et al.Press Release On April 28, 2021, Nepthali Luna and his son, Devon Luna, pleaded guilty in connection with their roles in a scheme to sell used, high-mileage vehicles with false, low mileage readings entered on the vehicles odometers, titles, and odometer disclosure statements. Docket Numbers: 1:20-cv-00306-RP (W.D. );2:16-CR-316 (D.N.J. Court Denies Indivior's Motion to Dismiss Indictment Alleging Illegal Opioid Marketing The charges in the indictment stem from Indivior's marketing of Suboxone, an opioid drug used in the treatment of addiction. The government alleged 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. My Doctor Suggests is also subject to a civil consent order that requires the company to stop fraudulently labeling its products and to issue full refunds to affected consumers. 18-cr-20506 (S.D. Victims never received any lottery winnings. The government alleged in its complaint that Travalino sold various preparations through his storefront and a website as guaranteed cures and treatments even after receiving a joint warning letter from FDA and FTC advising him that the distribution of his products violated the Federal Food, Drug, and Cosmetic Act and Federal Trade Commission Act. Simpson case is a case of sexual assault and wrongful death. The material was found on Adrianzens cell phone and laptop computer when government agents executed search warrants on both devices in connection with an unrelated fraud investigation. Based on the evidence presented, the court found probable cause to conclude that Defendant Maven Infotech Pvt. Two of the individual defendants, Jacob Geissler and Jonathan Doyle, are expected to be sentenced in federal court in Dallas on October 13 and 15, 2020, respectively. The defendants then caused the vehicles odometers and titles to reflect false, low mileages, and they sold the vehicles for inflated prices to unwitting consumers. The vast majority of Civil cases tried in court do not have a jury (libel and slander trials are the main exceptions). Canadian Men Charged in Alleged Mass-Mailing Elder Fraud Schemes United States v. Quaglia et al. In a complaint filed in February, the United States alleged the companys medicated feed labels did not list active drug ingredients or include adequate instructions for use. Court Orders Dish Network to Pay $280 million for Illegal Telemarketing CallsUnited States v. Dish Network, LLC Press Release People typically sue to make up for some sort of loss or injury they've suffered. Docket Number: 15-30332 (9th Cir./E.D. The charge against Gore carries a statutory maximum penalty of 5 years in prison. On March 26, 2021, U.S. District Judge John F. Walter found George Masaaki Kimura in civil contempt for violating an order for permanent injunction. The court also observed that even if it had jurisdiction to consider plaintiffs challenge to the FDA guidance document, the plaintiffs request to enjoin FDA from conducting an enforcement action was an impermissible attempt to test a defense pre-enforcement. Weaver and Kaplan were ordered to report to prison on January 9, 2017. On January 22, 2020, two Mississippi men were sentenced on charges stemming from their participation in a conspiracy to roll back odometers on used vehicles. MD.). 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. 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. 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. Yvelice Villaman Bencosme, M.D., Lisett Raventos, Jessica Palacio, and Maytee Lledo each were charged by information in the Southern District of Florida with one count of conspiracy to commit wire fraud, and Palacio also was charged with one count of making a false statement to the FDA. Smith sold Miracle Mineral Supplement or MMS, which he touted as a cure for cancer, AIDS, malaria, hepatitis, lyme disease, asthma, the common cold, and various other diseases. 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. Two Peruvian Men Plead Guilty in Call Center Extortion Scheme An FDA inspection performed in August of 2015 revealed the presence in the facility of Listeria Monocytogenes, a bacterium that poses a significant risk to public health. Smith received the money, kept a portion for herself, and sent the remainder to individuals in Jamaica. 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. 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. The conflict started with an Amazon contract. The indictment alleges that Indivior obtained billions of dollars in revenue from Suboxone Film prescriptions by deceiving health care providers and health care benefit programs into believing that Suboxone Film was safer, less divertible, and less abusable than other opioid-addiction treatment drugs. 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. Hidalgo, Hermoza and the other callers said these consequences could be avoided if the victims immediately paid settlement fees. Many victims made monetary payments based on these threats. Docket Number: 1:15-CR-0042 (D.D.C.). On December 10, 2014, the United States filed a civil action against William H. Oshiro d/b/a RZM Food Factory to enjoin him from violating the Federal Food, Drug and Cosmetic Act, including violations of current Good Manufacturing Practice standards. Docket Number: 2:18-CV-283 (D. Nev.). Press ReleasePress Release On June 25, 2018, Michael Rossi was sentenced to 63 months in prison plus three years of supervised release in connection with a telemarketing scheme that defrauded thousands of victims, many of whom were elderly, out of more than $2.7 million. FKOL also agreed to implement a compliance and ethics program designed to prevent, detect, and correct violations of U.S. law relating to FKOLs manufacture of cancer drugs intended for terminally ill patients. Foo Yuan, which is based in Long Island City, New York, prepares, packs, holds and distributes refrigerated and frozen ready-to-eat fish balls, fried fish cakes and fried fish balls. Docket Number: 2:18-CR-00726 (D. N.J.). Medical Device Maker Pleads Guilty to Misbranding and Agrees to Pay $36 Million to Resolve Criminal Liability and False Claims Act AllegationsUnited States v. Biocompatibles, Inc.Press ReleaseDocket Number: 1:16-MJ-00710 (D.D.C.). Simultaneously with the filing of this action, Dutch law enforcement agents executed search warrants on the business address used by both companies and on Dekkers home address. Docket Number: 1:20-cv-493 (W.D. Defendant Sentenced in Connection with a Lottery Scam Based in JamaicaUnited States v. Felecia Roxanne Lindo On July 24, 2019, the Department filed a complaint in District Court for the District of Columbia alleging that Facebook violated an administrative order issued by the FTC in 2012 by misleading users about the extent to which third-party application developers could access users personal information. On February 5, 2021, the court entered a stipulated preliminary injunction that superseded the temporary restraining order and prevents the defendants from dispensing controlled substance prescriptions written by a particular prescriber during the pendency of this case. The order, part of the United States long-running racketeering lawsuit against the cigarette companies, also requires them to attach the same statements to cigarette packages for two weeks at a time, for a total of twelve weeks over two years. Docket Number: 1:20-cv-2016 (E.D.N.Y.). 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. According to the complaint, victims sent hundreds of millions of dollars to defendants in fees, but received nothing of value in return. 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; Complications from the disease can also lead to miscarriage. Calif.). Downing and its immediate predecessor, NuVision Pharmacy, Inc., adulterated compounded sterile injectable drugs by preparing them under insanitary conditions, and by using methods or controls that did not comply with current good manufacturing practices. Oshiro has an extensive history of growing, processing, and packaging ready-to-eat mung bean, alfalfa, clover, and radish sprouts under grossly insanitary conditions. Sentencing hearings for Geissler, Doyle, and Patel are set for July 27, July 29, and August 10, 2020, respectively. Ala.). 4 February 2023 Animal Law Raventos is the first of the four charged defendants to plead guilty. Along with pleading guilty, the company agreed to pay a criminal fine of $30 million and forfeit an additional $20 million. and United States v. Lily Popular Varieties & Gifts, Inc. et al. 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). The verdict was the first ever in an action to enforce the Telemarketing Sales Rule and Do Not Call Registry rule. In pleading guilty, Gali admitted that from 2006 through 2011, he and his brother, Chaim Gali, devised a scheme to defraud consumers by misrepresenting the mileages of used vehicles. Press Release

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