Less than a month after B. Braun resumed buying syringes from AM2PAT, AM2PAT manufactured B. Braun saline syringes contaminated with Serratia marcescens bacteria. According to the complaint in the case, the defendants mailed more than 1 million solicitations to potential victims in the United States, France, Germany, the Netherlands, Japan, and elsewhere, grossing about $4.5 million annually since 2016. Docket Number: 1:16-CR-20912 (S.D. The charge is not based on printing that search or document. Victims who send payments receive no prize. Fifth Defendant Sentenced in Debt Relief Fraud SchemeUnited States v. Nelson et al. 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. 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. Docket Number: 1:19-CR-20658-RNS (S.D. Farris was the sales manager in charge of the telemarketing sales floor. Jonathan Doyle, the president of USPlabs, and Jacobo Geissler, the CEO of USP Labs, pleaded guilty February 21 and February 28, respectively, to conspiracy to introduce misbranded food into interstate commerce. Arbor challenged FDAs determination that the original formulation of its drug, Nymalize, was not withdrawn for reasons of safety and effectiveness, which would allow approval of potential generic versions of Arbors withdrawn drug. WebCases 1 - 10 of 199,554. La. Tex.). On November 4, 2016, Sheikh Waseem Ul Haq was sentenced to time served, and three years supervised release, for his role in a long-running conspiracy to ship pharmaceuticals from Pakistan and the United Kingdom (UK) to customers in the United States. The agreement resolves pending state court lawsuits in Connecticut, Mississippi, and South Carolina, as well as potential claims by the Justice Department, 18 states, and the District of Columbia. 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. Yabe pled guilty to one misdemeanor violation of the Federal Food, Drug, and Cosmetic Act. For more information about this case and any further updates, please see this page. Press Release On November 21, 2016, defendant John Vartanian was sentenced to 27 months imprisonment and ordered to pay $1.2 million of restitution in connection with a fraudulent debt relief services scheme based in Orange County, California. Sonar, a New Jersey corporation, manufactures drugs for Stratus. From 2006 to 2010, Akinyoyenu owned and operated an internet pharmacy called Apex Online Pharmacy. In addition to entering the preliminary injunction, the court set a show cause hearing for May 11 regarding the defendants alleged violations of the previously issued temporary restraining order. Docket Number: 1:17-CR-10288 (D. Docket Numbers: 1:19-cr-87; 1:19-cr-88 (S.D. Court Denies Drug Companys Motion for Emergency Relief in Case Involving Challenge to FDAs Drug Withdrawal Determination. The injunction requires the defendants to destroy dietary supplements that are in their possession and implement several consumer safety measures before resuming the manufacturing or distributing of dietary supplements. According to charges, Gore sent collection letters to victims of the psychic scheme after the victims checks bounced. 8:14-CR-0198-DSF; 8:15-CR-0041 (C.D. Docket Number: 2:16-cr-71 (D. Nev.). 3 minutes ago ALBUQUERQUE, N.M. (AP) Three former womens basketball players at Eastern New Mexico University have filed a federal civil rights lawsuit claiming their coach coerced them to undergo treatments that amounted to sexual assault by her volunteer trainer husband. Docket Number: 2:14-CV-6791 (E.D.N.Y.). Isomeric manufactures, labels, and distributes sterile drugs, including injectable hormones, injectable corticosteroids, and ophthalmic drops. On May 11, 2021, a Miami grand jury returned a two-count indictment against Jessica Palacio in connection with Palacios role in an alleged clinical trial fraud scheme. Violations included having mold covering the ceiling of the walk-in cooler and moving racks of buns from the floor to food production surfaces without sanitizing them. The family of Tyre Nichols filed a federal lawsuit against the city of Memphis, its police department and the officers involved in the fatal beating of the 29-year-old Black White entered a temporary restraining order against an Oklahoma company that touted an unapproved colloidal silver product as a COVID-19 treatment. 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. His conduct in this case violated the injunction. The complaint alleged that defendants had a history of processing food products under insanitary conditions. Mich.). According to the complaint, consumers pay for items supposedly sold through the websites but never receive those purchases. ) or https:// means youve safely connected to the .gov website. The resolution the largest recovery by the United States in a case concerning an opioid drug includes the forfeiture of proceeds totaling $647 million, civil settlements with the federal government and the states totaling $700 million, and an administrative resolution with the Federal Trade Commission for $50 million. United States v. Vivint Smart Home, Inc., Case No. Court Enters Preliminary Injunction Against Tech-Support Wire Fraud SchemeUnited States v. Elagoon Business Solutions Pvt Ltd d/b/a Computer Phone Assist The court in both matters granted temporary restraining orders to limit the defendants ability to distribute or dispense controlled substances. Ltd., an India-based company. Calif.). Ill.). According to the indictment, the aegeline-containing product was associated with a 2013 outbreak of severe liver injuries before being pulled from the market. SARMs are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids. Permanent Injunction Entered Against Vermont Dairy FarmUnitedStates v. Correia Farm Limited Partnership d/b/a Wynsum Holsteins, and Anthony Correia, Barbara Correia, and Stephen Correia, Press ReleaseDocket Number: 1:15-CV-0256 (D. Vt.). On February 5, 2021, Maytee Lledo pleaded guilty to conspiracy to commit wire fraud in connection with an scheme to falsify clinical trial data. 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. In filings unsealed on January 29, 2021, U.S. District Judge Mary Scriven issued a temporary restraining order enjoining a Tampa pharmacy and two of its employees from dispensing opioids and other controlled substances. Docket Number: 1:21-cr-00006-RM (D. Colo.). Depending on format, billable pages are calculated in two different ways. From January 2013 through July 2013, Long created and deposited more than 750,000 remotely-created checks, totaling more than $22 million and drawn on the bank accounts of unwitting victims. 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 Operator of Odometer Fraud and Title Scheme SentencedUnited States v. BasnightPress Release 18-1785 (7th Cir.) District Court Enters Consent Decree of Permanent Injunction Against Maine Fish Processor UnitedStates v. Mill Stream Corporation and Ira J. Frantzman, Press ReleaseDocket Number: 1:16-CV-0080 (D. In a civil lawsuit, Carroll alleges Trump raped her in a Manhattan department store in the 1990s. 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). The Court previously enforced an identical waiver in dismissing the appeal of one of Lytles co-defendants. The complaint alleges that the defendants, as part of a wire fraud scheme, created websites portrayed as online stores offering products for sale to American consumers, including health and safety related items such as hand sanitizer and disinfecting wipes that have become scarce during the COVID-19 pandemic. Defendants Foreign Properties Sold for $1,665,000 To Obtain Restitution for Fraud VictimsUnited States v. Shevin Goodman On April 23, 2020, Judge Timothy Kelly of the U.S. District Court for the District of Columbia granted the United States motion to enter a stipulated order against Facebook, Inc. Roos has not reopened. FDA also discovered the presence of L. mono at the facility, including samples taken from food contact surfaces and a sample of finished sprout product collected in May 2012. British Man Sentenced to 70 Months in Prison for Fraud Scheme That Victimized Hundreds of Thousands of U.S. Consumers United States v. Long, Press Release Reyes then resold these vape cartridges for profit to a vape shop located in Dallas. Baxter Healthcare Corporation Agrees to Pay More Than $18 Million for Failing to Follow Good Manufacturing PracticesUnited States v. Baxter Healthcare Corporation Press ReleaseDocket Number: 1:17-CV-0015 (W.D.N.C.). The clinical trial sought to compare the efficacy of two asthma treatments in a pediatric population. On July 5, 2017, the district court entered a consent decree of permanent injunction against Medistat RX, LLC, a compounding pharmacy, and three individual defendants: Mark D. Acker, who served as its Chief Executive Officer, Timothy L. Fickling, who served as its Production Manager, and V. Elaine Waller, who served as its Pharmacist-in-Charge and Quality Manager. The civil resolution has been entered in the Western District of Texas, where a whistleblower qui tam complaint had been filed. Sunset Natural Products was a dietary supplement manufacturer and distributor in Miami, Florida that, in addition to manufacturing its own products, also acted as a contract repacker/relabeler of previously encapsulated dietary supplements. 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. 766 [see 2409] (Partition suits where United States is tenant in common or joint tenant). Docket Number: 2:20-cr-00188 (C.D. 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. The district court ordered the tobacco companies to issue corrective statements as part of the 2006 permanent injunction, which followed the nine-month civil racketeering trial. In reality, Romeos companies sold Chinese knock-off hoodia that was imported using forged documentation. Docket No. 1349, and with making a false statement to a regulatory investigator with the Food & Drug Administration, in violation of 18 U.S.C. Some states have statutes that allow longer limitation periods for civil lawsuits resulting from criminal conduct, including In a complaint filed in May, the United States alleged that inspections at Medistat revealed numerous insanitary conditions, including significant microbial contamination in aseptic processing areas and the failure to use sterile wipes to clean critical surfaces in the pharmacy. Case No. 1345) against Michael Travalino to stop him from marketing herbal remedies as purported treatments for COVID-19 and other serious medical conditions. United States v. Yabe, Hisao, Press Release 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 injunction requires, among other measures, that the defendants retain an independent expert to conduct an inspection of Syfrett Feed and certify that the firm operates in conformity with current good manufacturing practices. 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. Docket Number: 19-CR-0282 (D. The complaint alleges that Cantrell, a compounding pharmacy, distributed adulterated drugs in interstate commerce and caused drugs to become adulterated while held for sale after shipment of a component in interstate commerce. The complaint alleges that the defendants send fraudulent solicitations styled as notifications that the recipient has won a large package of cash and prizes, typically worth more than $350,000. On March 24, 2020, U.S. District Judge Eric Komitee entered a preliminary injunction under 18 U.S.C. Long was charged with multiple counts of wire fraud, aggravated identity theft, and money laundering for a scheme that victimized hundreds of thousands of account holders throughout the United States. This rule provides that the first step in an action is the filing of the complaint. 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. Victims sent money to mailboxes located in the United States and received no cash prizes. Lytle and another QLaser distributor, Irina Kossovskaia, were indicted earlier this year on related charges of mail fraud, wire fraud, conspiracy, and contempt. Court Permanently Enjoins Canadian Mass-Mailers From Sending Fraudulent Solicitations United States v. Thomas, et al. Both defendants were also sentenced to one year of supervised release following their imprisonment and a $5,000 fine. United States v. Christopher Reyes, Case No. Internet Pharmacy Operator Sentenced to 25 Years Imprisonment for Wide-Ranging Criminal Enterprise, United States v. Leroux (S.D.N.Y.) On November 4, the United States filed an injunction action against Scilabs and Edalat seeking this relief. One 2,460 % potent lot of Pharmakon morphine sulfate nearly caused the death of an infant at an Indianapolis hospital in 2016. According to the complaint, victims sent hundreds of millions of dollars to defendants in fees, but received nothing of value in return. In order to gain the trust of the victim and induce him to continue to make payments, Allen traveled from Jamaica to the United States and falsely portrayed herself to the victim as an FBI agent, provided him with a cellphone, and directed him to speak with the person on the line, who was her co-conspirator in Jamaica. During an inspection in 2015, FDA observed that the firm failed to have adequate HACCP plans to control the hazards posed by several pathogenic bacteria, including Clostridum botulinum, Clostridum perfringens, and Listeria moncytogenes. On July 16, 2018, the District Court permanently enjoined New York companies Euroline Foods, LLC, and Royal Seafood Baza, Inc., along with company owner/operators Eduard Shnayder, Syoma Shnayder and Albert Niyazov, and company operator Oleg Polischouk, from violating the Food, Drug and Cosmetic Act (FDCA). The quick answer is: it depends. In pleading guilty, Gutierrez admitted that he oversaw a series of call centers in Peru that threatened Spanish-speaking victims with various consequences if they failed to pay non-existent debts. On July 31, 2015, the United States filed a complaint against three dietary supplement makers, Atrium Inc., Aspen Group Inc., Nutri-Pak of Wisconsin Inc., and the owners of the three firms, James F. Sommers and Roberta A. Sommers, based on violations of the Federal Food, Drug, and Cosmetic Act. In a civil lawsuit, Carroll alleges Trump raped her in a Manhattan department store in the 1990s. Court Permanently Enjoins New York Company from Distributing Adulterated and Misbranded Dietary SupplementsUnited States v. Riddhi USA, Inc., et al.Press Release Six defendants were convicted of conspiracy, mail fraud, and wire fraud charges following trial in 2015. 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. As part of the settlement, PharMedium may not manufacture, hold, or distribute its drugs from its Tennessee facility unless PharMedium complies with specific remedial measures set forth in the consent decree. If you believe you are a victim in this matter and would like to speak with someone regarding the case, please call Special Agent Chad Medaris, FDA Office of Criminal Investigations, at 214-887-4174. The injunction requires the defendants to cease all operations connected to the company, and not to resume operations until FDAdetermines that their manufacturing practices have come into compliance with the law. In addition, the company produced fish products under insanitary conditions based on its failure to comply with Current Good Manufacturing Practices. Press Release 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. On March 8, 2021, the court unsealed an indictment charging four individualsDr. Docket Number: 15-cr-20471 (S.D. On May 18, 2016, drug and medical device company B. Braun Medical Inc. (B. Braun) agreed to pay $4.8 million in penalties and forfeiture and up to $3 million in restitution to resolve its criminal liability for selling contaminated B. Braun pre-filled saline flush syringes in 2007. A locked padlock In a criminal information previously filed in the District of Nevada, the United States charged FKOL with violating the Federal Food, Drug and Cosmetic Act by concealing and destroying records prior to a 2013 FDA plant inspection in Kalyani, India. The company voluntarily terminated production at the plant on Feb. 14, 2007, and recalled all peanut butter manufactured there since January 2004. ), Docket Numbers: 2:16-CR-0124 (E.D. Although Baxter distributed the adulterated products it made in that clean room, there was no evidence of impact on the IV solutions from the mold found on the filters. District Court Enters Permanent Injunction Against Eastern Michigan Seafood and Salad Processor The governments complaint seeks preliminary and permanent injunctions, civil penalties, and other equitable relief. One co-defendant in the scheme was sentenced in March, and a third defendant is set to be sentenced in July. The money laundering was in connection with an international lottery fraud scheme involving co-conspirators in Florida and Jamaica. On August 11, 2020, the United States District Court for the Middle District of Florida entered a temporary restraining order pursuant to 18 U.S.C. Consent Decree Entered Against Three Dietary Supplement ManufacturersUnited States v. Atrium Inc., et al.Press ReleaseDocket Number: 1:15-CV-0927 (E. D. Wis.). Dietary Supplement Manufacturer Enjoined from Distributing Adulterated, Misbranded Products Marketed as DrugsUnited States v. EonNutra LLC et al.Press Release 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. (respectively). 841(a) and (b)(l)(B). Blue Bell agreed to plead guilty to two misdemeanor counts of distributing adulterated ice cream products and pay a criminal fine and forfeiture amount totaling $17.25 million. The indictment alleged that the defendants misrepresented the nature and origin of the active ingredients in their products. The action, brought under the anti-fraud injunction statute (18 U.S.C. 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.

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