On January 29, 2019, the district court issued a default judgment and permanent injunction pursuant to 18 U.S.C. Bostock v. Clayton County, 590 U.S. (2020) The Supreme Court has issued a landmark decision in Bostock v. Clayton County, holding that . 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. Two Pakistani National Sentenced for Conspiring to Illegally Ship Pharmaceuticals into the United StatesUnited States v. Ul HaqPress ReleaseDocket Numbers: 1:12-MJ-00810 (D.D.C.). On March 24, 2020, U.S. District Judge Eric Komitee entered a preliminary injunction under 18 U.S.C. The complaint alleges that consumers pay for items supposedly sold through the websites but never receive those purchases. Long did not have authorization to charge any of these victims accounts. The fine, the largest ever in a food safety case, is part of a deferred prosecution agreement that will allow Chipotle to avoid conviction if it complies with an improved food safety program. Arbor Pharmaceuticals v. Cochran, Mass.). 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; The United States criminal trial against Indivior is scheduled to begin on May 11, 2020. In return, victims received worthless costume jewelry. Cal.). 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. Docket Number: 1:16-CV-2770 (E.D.N.Y.). 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. 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. In denying MediNaturas motion, the court held that the company could not establish a likelihood of success on the merits of those claims without first asking the court to reconsider its dismissal of them. On May 4, 2017, the district court entered a consent decree of permanent injunction against Syfrett Feed Company, Inc.; the companys owner and president, Charles B. Syfrett I; the companys vice president, Melissa S. Montes De Oca; and its operations manager, Charles B. Syfrett II. On Dec. 4, 2017, the Ninth Circuit Court of Appeals affirmed the district courts denial of Dr. W. Scott Harkonens coram nobis petition seeking to overturn his fraud conviction for ineffective assistance of counsel at trial. Sentencing before U.S. District Judge Beth Bloom is set for April 16, 2021, in Miami. On December 19, 2019, Judge Chhabria of the Northern District of California granted the governments motion for judgment on the pleadings (and denied Plaintiffs motion for judgment as a matter of law) as to three claims in a challenge by several environmental and food safety advocacy groups to FDAs approval of a genetically engineered salmon that will be sold as food, and FDAs guidance pertaining to such approvals. Docket Number: 1:20-cv-21601 (S.D. Cadden was convicted of 57 counts following trial, including racketeering, racketeering conspiracy, mail fraud, and violations of the Food, Drug and Cosmetic Act. 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. Defendants named in the USP Labs matter pleaded guilty in 2019 to felony charges in connection with a scheme to fraudulently sell workout supplements. Cal. Mass.). The government alleged that the companys fish products were adulterated pursuant to the Food, Drug, and Cosmetic Act. Defendant Sentenced in Prescription Drug Diversion SchemeUnited States v. Karen Turner Press Release Docket Number: 1:20-cr-123; 1:20-cr-122 (W.D. Oshiro has an extensive history of growing, processing, and packaging ready-to-eat mung bean, alfalfa, clover, and radish sprouts under grossly insanitary conditions. Va.). According to the complaint, when prospective customers failed a credit check, Vivints sales representatives used the identities and credit reports of other, unknowing consumers to complete the sale on multiple occasions over several years. On September 15, 2017, Shashana Stacyann Smith was sentenced to serve 24 months in prison related to her role in a fraudulent lottery scheme based in Jamaica. The Fourth Circuit recently held that it did, joining two other appellate courts and worsening an existent circuit split. Docket Number: 3:15-CV-3769 (D.N.J.). Before trying a Civil case the judge will read the relevant case papers and becomes familiar with their details. Defendant Sentenced for Role in Jamaican Lottery ScamUnited States v. Vania Lee AllenPress Release On April 26, 2021, Cameroonian national Desmond Fodje Boba arrived in Pittsburgh following his extradition from Romania. 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. 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. Blue Bell Creameries Sentencing Date Set in Listeria Contamination Case, United States v. Blue Bell Creameries Employee of Chinese Chemical Supplier Sentenced in Scheme to Sell Mislabeled Dietary SupplementsUnited States v. GaoPress Release 2:21-cr-35(E.D.N.Y.). Civil Enforcement Actions Under Controlled Substances Act Announced Against Two Physicians Related to Opioid Distribution United States v. Gregory J. Gerber, M.D., et al. On April 29, 2019, Caprice R. Bearden was sentenced in Indianapolis for her role in a conspiracy to defraud the U.S. Food and Drug Administration concerning the distribution of under- and over-potent compounded drugs. 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. Raventos is the first of the four charged defendants to plead guilty. Vendstar sales representatives misrepresented to victims the likely profits they would earn, how past customers were doing, the availability of high-profit locations, and services that purported locating companies would provide. Docket Number: 8:20-cv-1794 (M.D. 1349, and with making a false statement to a regulatory investigator with the Food & Drug Administration, in violation of 18 U.S.C. The complaint alleged that FDA issued a warning letter to the company in 2018, and that tests in 2018 and 2019 revealed Listeria species inside the facility and E. coli in water used to irrigate sprouts. Chicago Dietary Supplement Companies Ordered to Comply with FDCA United States v. Global Marketing Enterprises, Inc., et al.Press Release Chief Executive Officer and Manager of Fraudulent Business Opportunity Seller Sentenced to PrisonUnited States v. Edward WeaverPress Release 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. FDA had previously warned NAE, after inspections performed in 2013 and 2014, of its failures to maintain sanitary conditions. Peruvian Man Sentenced to 88 Months of Imprisonment for Overseeing Call Centers that Threatened and Defrauded Spanish-Speaking U.S. Consumers, United States v. Rodolfo Hermoza Docket Number: 2:20-cr-00188 (C.D. District Court Issues Temporary Restraining Order Against Florida Businesses in Direct-Mailing SchemeUnited States v. Marotta, et al. On June 16, 2020, Lawrence B. Ryan was sentenced by U.S. District Judge Robert G. Doumar to 10 months imprisonment for his role in a conspiracy to unlawfully distribute controlled substances and to introduce into interstate commerce misbranded drugs with the intent to defraud or mislead. The consent decree requires Neptune to cease all manufacturing operations and requires that, in order for defendants to resume distributing seafood products, the FDA first must determine that Neptunes manufacturing practices have come into compliance with the law. ); 2:12-CV-2264 (D.N.J. In pleading guilty, Bearden admitted that she and her co-defendant, Paul J. Elmer, Pharmakons former president, lied during multiple FDA inspections about test results concerning under- and over-potent compounded sterile drugs manufactured by Pharmakon and distributed to hospitals nationwide. 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. Docket Number: 1:20-cv-5356 (N.D. Ill.). Twenty other individuals also have been convicted in connection with Vendstar, many of whom are awaiting sentencing. Sitesh Patel, the vice president of S.K. 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. Mich.). Bruner-McMahon v. Jameson, et al. Docket Number: 2:18-CR-00726 (D. N.J.). 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. 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. 1:20-cr-20190(S.D. Tenn.). United States v. Valdes et al., McLaughlin helped Burnett commit odometer fraud by fraudulently issuing new Georgia titles with false low mileages in exchange for cash. Victims were told they must urgently pay fees to collect their winnings. On September 25, 2015, the district court entered a consent decree of permanent injunction against Sunset Natural Products Inc., and the firms co-owners, Dr. Teresa Martinez (a.k.a Dr. Teresa Martinez-Arroyo) and Elsy Cruz, stopping them from violating the Food, Drug, and Cosmetic Act by manufacturing and distributing adulterated dietary supplements. The company voluntarily terminated production at the plant on Feb. 14, 2007, and recalled all peanut butter manufactured there since January 2004. The court denied plaintiffs two other motions for a preliminary injunction and dismissed MediNaturas claims challenging FDAs addition of its products to the import alert. Note: Read the "Justice for All Act of 2004", which describes crime victims rights. Press ReleaseDocket Number: 2:14-CV-4395 (E.D.N.Y.). Defendants Sentenced in Texas Prescription Drug Smuggling Ring United States v. Catherine Nix,Tom Giddens, and Wanda HollisPress ReleaseDocket Number: 6:14-CR-49 (E.D. ); 2:14-CV-1156 (D.N.J. One of his co-defendants will be sentenced in April, and another co-defendant is set for trial later this spring. A civil lawsuit is a legal process by which a person or entity can hold another person or entity liable for some wrong, injury, or damage. The Court also denied two motions to intervene in the case by a data privacy advocacy group and a private individual. Evidence at trial showed Cadden directed and authorized the shipping of contaminated MPA that caused the outbreak.Cadden also authorized the shipping of other drugs before test results confirming their sterility were returned, never notified customers of nonsterile results, compounded drugs with expired ingredients, and employed an unlicensed pharmacy technician. The permanent injunction entered by the court enjoins the defendants from making various claims in any advertisements, solicitations, or promotional materials sent through the mail, including a ban on any advertisements on behalf of any actual or fictional individual or entity purporting to offer psychic, clairvoyant or astrological items or services for a fee. 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. Dr. Bencosme served as the principal investigator for a clinical trial conducted at UM Research intended to investigate the safety and efficacy of an experimental asthma medication in children. Ark.). (respectively). Docket Number: 1:20-cr-123 (W.D. Case No. On June 6, 2018, the United States filed a civil action seeking to enjoin Innovative BioDefense, Inc., of Lake Forest, California and its CEO, Colette Cozean, from distributing Zylast antiseptic hand sanitizer products that are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. 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. 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. L.A. Star processed and distributed a variety of ready-to-eat fish products. Docket Number: 3:18-CV-0127 (N.D. The complaint further alleged that FDA tests showed that some of the defendants products contained undisclosed pharmaceutical ingredients such as sildenafil, the active ingredient in Viagra. In a complaint filed in March 2019, the government alleged that the defendant uses telemarketers who, posing as computer technicians and often impersonating well-known technology companies, contact unsuspecting consumers and falsely inform them that their computers have serious problems; the telemarketers then falsely tell consumers that the problems are resolved and then demand payment on one or more occasions for purported technical-support services. Ronald Rodis was paid for the use of his law license in an effort to lend legitimacy to the operation. Juxtapid was approved to treat patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder that causes abnormally high levels of LDL-C, or bad cholesterol. Defendants Plead Guilty in USP Labs Dietary Supplement Scheme; Sentencings Set for August 2019United States v. USP Labs, Press Release 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 verdict was the first ever in an action to enforce the Telemarketing Sales Rule and Do Not Call Registry rule. On March 31, U.S. District Judge James Jones denied Indiviors motion to dismiss a 28-count indictment alleging the company engaged in healthcare fraud, wire fraud, mail fraud, and conspiracy to commit the same. Pedersens former company, My Doctor Suggests LLC, agreed plead guilty to a one-count misdemeanor criminal information charging distribution of misbranded drugs in violation of the Federal Food, Drug, and Cosmetic Act. Cal. Long previously operated as a third-party payment processor, creating and depositing checks on behalf of numerous merchants. Docket Number: 2:17-CV-0852 (D. Utah). Several FDA inspections since 2011 revealed violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations and current Good Manufacturing Practice regulations. The consent decree of permanent injunction was entered by U.S. District Court Judge Richard G. Andrews on Jan. 26. Before closing in July 2010, Vendstar made approximately $10 million to $12 million in sales per year. 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. 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. Tex.). Laboratories pleaded guilty on February 25 to introduction of misbranded food into interstate commerce, and USPlabs pleaded guilty to conspiracy to introduce misbranded food into interstate commerce on March 5. La. Mich.). Weaver and Kaplan were both found guilty after a 6-week trial last year of conspiracy, mail fraud, wire fraud, and making a false statement. Docket No. 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. These defendants ran a mail fraud scheme in which victims received letters from alleged world-renowned psychics, offering purportedly personalized psychic predictions and services for a fee. 1:20-cv-02066 (D.D.C.). Wash.). 8:14-CR-0198-DSF; 8:15-CR-0041 (C.D. Press Release 1:20-cr-49 (W.D. Yabe pled guilty to one misdemeanor violation of the Federal Food, Drug, and Cosmetic Act. In addition, S.K. Another co-conspirator, Omar Portocarrero Caceres, previously was sentenced to 46 months. Press Release 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. Press Release The complaint alleged that the defendants failed to adequately investigate or take sufficient corrective action to correct the insanitary conditions. Favorite Pants In 2007, when Custom Cleaners, a neighborhood dry cleaner, returned what Judge Roy Pearson claimed to be the wrong pair of pants, Pearson, an administrative law judge, decided to take action and sue for $67 million. 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