According to the information, Bencosme and her co-conspirators—including Bencosme’s medical practice receptionist, Maytee Lledo, and two UM Research study coordinators, Jessica Palacio and Lisett Raventos—fabricated the clinical trial by falsely representing in medical charts and other sources that subjects were participating in the trial when, in fact, they were not participating or taking the study medication as required. The defendants made misrepresentations about profits, operating their own vending routes, locations, and ongoing customer support to induce the victims to buy what was advertised as a complete business package, but turned out to be essentially worthless. The court previously entered a default judgment against the entity and two principals located in the United States. The Ninth Circuit rejected Harkonen’s arguments, holding that his attorneys’ decision to forego calling defense expert witnesses was an appropriate “judgment call” made by competent counsel after an extensive search for and preparation of multiple defense experts. On January 8, 2020, Lawrence B. Ryan pleaded guilty in the Eastern District of Virginia, Norfolk Division, to one count of conspiracy to unlawfully distribute controlled substances and to introduce into interstate commerce misbranded drugs with intent to defraud or mislead. 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. The suit was dismissed for lack of standing because neither the association nor its only identified member established an injury caused by defendants FDA and HHS. During a bench trial conducted last summer, the government presented evidence that each of the defendants had failed to comply with current good manufacturing practices, failed to keep records necessary to evaluate food safety, and processed fish in a way that could lead to Listeria monocytogenes contamination, all in violation of the federal Food, Drug, and Cosmetic Act (“FDCA”). The Court set Romeo's sentencing for June 21. For more information, see the Press Release dated May 1, 2020. Medical Device Maker ev3 Agrees to Plead Guilty and Pay $17.9 Million for Distributing Adulterated “Onyx” DeviceUnited States v. ev3, Inc., et al.Press Release 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.). The defendants included the alleged direct mailers who organized the scheme, mailing list managers, “cagers” who opened and processed victim returns, and payment processors. § 1345 against three Vietnamese defendants, Thu Phan Dinh, Tran Khan, and Nguyen Duy Toan. Docket Number: 1:20-cv-493 (W.D. The verdict is the latest development in a lawsuit that the Department filed on behalf of the Federal Trade Commission (“FTC”) in May 2011, seeking, among other things, a permanent injunction and civil penalties against the defendants for engaging in widespread deceptive and abusive telemarketing practices in the course of selling and promoting DVDs and films. Weir admitted that claims the device could safely and effectively treat virtually any disease were false and intended to mislead consumers. In a July 2019 complaint, the government alleged that Facebook violated a 2012 FTC Order and committed new violations of the FTC Act by misrepresenting to consumers how to protect personal data and how Facebook used such data. Docket Number: 8:20-cv-1794 (M.D. On March 27, 2015, a federal district court entered a consent decree of permanent injunction against L.A. Star Seafood Company, Inc. of Los Angeles, and its corporate officers Sima Goldring and Sam Goldring to prevent the distribution of adulterated seafood products. Va.). On February 12, 2016, the district court entered a consent decree of permanent injunction against Mill Stream Corporation of Hancock, Maine, and its owner, Ira J. In addition to seeking injunctive and civil monetary penalty relief for violations of the CSA, the complaint also contains allegations under the False Claims Act for falsely billing Medicare for illegally dispensed controlled substance prescriptions. Docket Number: 1:20-cr-20190 (S.D. Note that a criminal case may involve both jail time and monetary punishments in the form of fines. The defendant made the argument that “separate but equal” education was sufficient to meet all students’ educational needs. The indictment alleged that the defendants misrepresented the nature and origin of the active ingredients in their products. As part of the scheme, the Galis used fictitious dealer names to purchase high-mileage vehicles, altered the odometers and vehicle titles, obtained “clean” Pennsylvania titles reflecting the false mileages, and sold the vehicles at auctions in Pennsylvania and New Jersey. The court also set a June 11 hearing on the government’s motion for preliminary injunction. These new compliance measures include privacy reviews for all new or modified Facebook products, a new Independent Privacy Committee on Facebook’s Board of Directors, and annual compliance certifications by Facebook CEO Mark Zuckerberg. The district court ordered Spectrum to pay $1.9 million in civil penalties, maintain adequate systems and controls to prevent future violations, and retain an outside consultant to evaluate its compliance program. (respectively). On March 3, 2016, the district court entered a consent decree of permanent injunction against Henry’s Farm, Inc., and its owner, Soo C. Park. Cal. Contact the Webmaster to submit comments. § 1345 against Elagoon Business Solutions Pvt Ltd., an India-based company. In March 2006, B. Braun started buying saline syringes from AM2PAT, Inc. (AM2PAT), despite already being aware of problems related to AM2PAT complying with current good manufacturing practices. Press Release United States v. Scilabs Nutraceuticals, Inc. and Paul P. Edalat, United States v. New York City Fish, Inc., Maxim Kutsyk, Pavel Roytkov, and Leonid Staroseletesky. Robinson pleaded guilty in February 2017 to one count of conspiracy to commit odometer tampering and securities fraud. Press Release 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. Six defendants were convicted of conspiracy, mail fraud, and wire fraud charges following trial in 2015. 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. The defendants instead took the first six months of payments and more as undisclosed up-front fees. Medtronic, which acquired ev3 subsequent to the course of criminal conduct, also agreed to pay $13 million in a separate matter as part of a global settlement to resolve False Claims Act liability arising from an investigation of alleged kickbacks paid to surgeons to use the Solitaire medical device, a second ev3 neurovascular product. Court Permanently Enjoins Canadian Mass-Mailers From Sending Fraudulent Solicitations United States v. Thomas, et al. Ind.). Medical Device Manufacturer Ordered to Pay $85 Million Following Guilty Plea for Failing to File Adverse Event Reports United States v. Olympus Medical Systems Corp. 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. Injunction Entered Against Eight Individuals and Entities That Ran Psychic Mail Fraud Scheme United States v. Metro Data Management, et al. Mich.). The Summons and Complaint in this matter may be found at this LINK. 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. The firm’s products were also found to be misbranded as the labels of the ready-to-eat soups failed to list all of the soups’ ingredients and failed to declare major food allergens. § 1345 against Maven Infotech Pvt. The orders enjoin the defendants from distributing or dispensing any controlled substances defined as “opiates” and “opioids” under the Controlled Substances Act (CSA), and from altering, deleting, destroying, mutilating, or transferring any records related to their controlled substance prescriptions or related treatment. Docket Number: 3:18-CV-0127 (N.D. The person who sues is called the plaintiff. Docket Number: 2:19-CV-111 (W.D. Pursuant to the decree, the defendants must cease all operations and obtain FDA’s approval before resuming the manufacture of dietary supplements in the future. On August 4, 2017, the district court entered a consent decree of permanent injunction against Isomeric Pharmacy Solutions, LLC and company principals William O. Richardson, Rachael S. Cruz and Jeffery D. Brown. 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 District Court Enjoins Florida Company from Distributing Adulterated and Misbranded DrugsUnited States v. MyNicNaxs, LLC et al. Ryan, at the time a licensed physician in Virginia, was paid $2 per drug order. Additionally, Lytle’s longtime live-in companion, Fredretta L. Eason, was charged with aiding and abetting Lytle’s criminal contempt. Docket Number: 1:16-CV-2770 (E.D.N.Y.). During the last five years it was open, Vendstar made approximately $62 million in sales. In reality, these companies were telemarketing operations that did very little to help homeowners after they paid upfront fees ranging from $3,500 to $5,500. The resolution with B. Braun included a non-prosecution agreement in which B. Braun admitted that it distributed B. Braun syringes that were adulterated under the Food Drug and Cosmetic Act. United States v. Indivior Inc. et al. 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. According to the indictment, the aegeline-containing product was associated with a 2013 outbreak of severe liver injuries before being pulled from the market. Indivior Inc. Indicted for Fraudulently Marketing Prescription OpioidUnited States v. Indivior Inc. Press Release ); 2:12-CV-2264 (D.N.J. On May 25, 2016, following eight days of trial, a jury found the defendants committed more than 117 million knowing violations of the TSR, including 99 million calls to phone numbers on the Do Not Call Registry, and more than four million additional calls in which they made misleading statements to induce DVD sales. On December 1, 2014, the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Neptune Manufacturing Inc. of Los Angeles and its corporate officers, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky, to prevent the distribution of adulterated seafood products. Tex.). The firm sold their soups to various distributors after receiving seafood from other states including Florida. According to the complaint, the defendants also misrepresent or fail to disclose material terms of those subscriptions, including that a lump sum will be paid up front, that subscriptions will automatically renew, and that subscriptions can be cancelled only by calling a customer service center that prevents and discourages cancellations or refunds. In a complaint filed in April, the United States alleged that inspections at Sonar and Stratus revealed violations of current good manufacturing practices that demonstrated a lack of quality oversight of the manufacturing, processing, and testing of drugs such that, if they continued, posed a threat to the public health. If the defendants seek to resume preparing, manufacturing and distributing food, they must implement remedial measures set forth in the injunction, notify the FDA of the measures taken, and receive written notification from FDA that they appear to be in compliance with the remedial requirements set forth in the injunction and the statute. On May 22, 2019, Hisao Yabe was sentenced to one year of probation and fined $5,000 for his failure to report to the Food and Drug Administration information that called into question the safety of a medical device manufactured by Olympus Medical Systems Corporation. On July 17, 2018, Gao Mei Fang (aka Amy Gao), a Chinese citizen, was sentenced to 12 months and a day of imprisonment on mail fraud and smuggling charges in connection with a scheme to sell mislabeled dietary supplements containing hidden synthetic stimulants. Secure .gov websites use HTTPS 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. In a complaint filed in January, the government alleged that the defendants knowingly conveyed hundreds of millions of fraudulent robocalls from foreign entities to American consumers. The convictions stem from a series of incidents in which multiple patients at hospitals in Europe and the United States experienced serious infections after being treated with a duodenoscope manufactured by Olympus. The court also found that defendants had distributed adulterated tuna salad sandwiches due to their failure to implement a plan pursuant to the agency’s Seafood Hazard Analysis and Critical Control Point (“HAACP”) regulations. The court sentenced SK Laboratories, based in Anaheim, California, the following day to two years of probation and $6 million in criminal forfeiture for its role in distributing the supplement. As a result, in March 2017, the United States sought and obtained the court’s appointment of a second realtor – in addition to the defendant’s realtor – to attempt to sell the properties. Vendstar sales representatives – with the knowledge and encouragement of Weaver and other managers – misrepresented the businesses’ likely profits, how its past customers were doing, the availability of high-profit locations, and the services that locating companies would provide. According to the CDC, several of the Maryland patients reported having eaten soft or semi-soft cheeses in the month before becoming ill. On March 11, 2014, the Food and Drug Administration suspended Roos’ food facility registration after determining there was a reasonable probability that food manufactured, processed, packed, or held by Roos would cause serious adverse health consequences or death to humans. 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. Complaint for Injunctive Relief and Civil Penalties Filed Against Online Consumer “Background Report” Provider United States v., Inc. et al.Press Release Blue Bell also agreed to pay an additional $2.1 million to resolve civil False Claims Act allegations regarding ice cream products manufactured under insanitary conditions and sold to federal military facilities. B. Braun Medical Inc. Agrees to Resolve Criminal Liability for its Sale of Contaminated SyringesUnited States v. B. Braun Press Release. According to the complaint, the defendants market various Zylast products as being effective against infection by pathogens such as the norovirus, rhinovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus bacteria, and Ebola virus, despite a lack of proof of the products’ safety and effectiveness and no approval from the U.S. Food and Drug Administration (FDA). Recent Case. Among other findings, the Court agreed with the government that statements of recommended uses published on company websites can be “labeling” under the FDCA pursuant to the Supreme Court’s seminal 1948 decision in Kordel v. United States. The callers threatened victims with negative credit reports, imprisonment, deportation, or property seizures that could be avoided only through the immediate payment of “settlement fees.”  Guerra was arrested in 2016 by Peruvian authorities and extradited to the United States last year. ); 2:15-CV-8889 (C.D. Burnett owned and operated Lifestyle Auto Broker LLC, a Georgia corporation that bought and sold used cars. In February 2012, a Michigan hospital traced infections among 16 surgical patients to a specific gel made by Pharmaceutical Innovations. Court Denies Indivior's Motion to Dismiss Indictment Alleging Illegal Opioid Marketing ), On June 21, 2017, the Court of Appeals for the Second Circuit affirmed the conviction and sentence of Edward “Ned” Weaver, who ran Vendstar, a Long Island company that sold worthless candy vending machine business opportunities. Docket Number: 1:20-cr-123; 1:20-cr-122 (W.D. At times, Eubank lowered mileage readings by more than 100,000 miles. 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. Robert “Larry” Lytle, 84, of Rapid City, South Dakota is currently serving a 12-year prison sentence after pleading guilty last year to introducing misbranded medical devices into interstate commerce with the intent to defraud and mislead and criminal contempt. Some of the companies’ products were previously seized in April 2015 by the United States as unapproved and misbranded drugs. On May 14, 2020, U.S. District Court Judge Ronald A. According to the complaint, FDA inspections documented significant deficiencies relating to cleanliness and hygienic practices to protect against food contamination, causing the defendants’ products to be adulterated under the law. Docket Number: 3:15-CR-496  (N.D. Court Dismisses Challenge to FDA’s Emergency Use Authorization for Hydroxychloroquine Related to COVID-19 Ass’n of Am. As the court found, Spectrum received about 1,600 reports of broken handles between 2008 and 2012, when it finally reported the problem to the CPSC. On November 3, 2016, the CEO and a senior manager of a Long Island, New York, company that fraudulently sold vending machine business opportunities were sentenced to prison. 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. So that witnesses speak from their own knowledge and do not change their story based on what they hear another witness say, they are kept out of the courtroom until they testify. This case caused upheaval in the education system of the southern United States, but schools in other parts of the country were als… 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 United States’ criminal trial against Indivior is scheduled to begin on May 11, 2020. According to the complaint, victims who received these solicitations sent payments through the U.S. and international mail systems to defendants Trends Service in Kommunikatie, B.V. (Trends), and Kommunikatie Service Buitenland, B.V. (KSB), both owned and operated by defendant Erik Dekker. Tpn that was compounded and distributed by Meds IV an agreement resolving their dispute U.S.... National living in the United States v. Michael P. Tricaso, D.O.Press Docket! 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