FDA inspections performed in 2013 and 2014 documented a pattern of insanitary conditions resulting in the presence of Listeria monocytogenes. Docket Number: 2:19-cv-00324 (W.D. Docket Numbers: 13-CR-120; 13-CR-500; 13-CR-501 (E.D.N.Y.). Runner was arrested in Spain, and extradition proceedings have been initiated in Spanish court. People who eat food contaminated with the Listeria monocytogenes bacterium can contract the disease listeriosis, which can be serious—even fatal—for vulnerable groups such as newborns and those with impaired immune systems. 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. Docket Number 19-cv-06589 (E.D.N.Y.). The violations stemmed primarily from norovirus outbreaks connected to employees’ failure to follow company food safety protocols at company-owned restaurants. The court’s order permanently enjoins the defendants from violating the Food, Drug, and Cosmetic Act and requires Gold Star and Pincow to implement consumer safety measures before continuing to process, pack, or distribute any fish or fishery products. N.C.). Arraignment is scheduled for May 6 in Abington, Virginia. 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. As part of Juxtapid’s 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. 17. Defendants named in the USP Labs matter pleaded guilty in 2019 to felony charges in connection with a scheme to fraudulently sell workout supplements. Under the order, the defendants would need to notify FDA and take remedial steps before processing various types of food. Both men pleaded guilty in March 2016 to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act (FDCA). 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. 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. Blue Bell Creameries Sentencing Date Set in Listeria Contamination Case, United States v. Blue Bell Creameries Ten of those defendants have been sentenced to prison, and 12 have been sentenced to probation. On January 12, 2017, Baxter Healthcare Corporation (Baxter) agreed to pay $18.158 million to resolve criminal and civil liability arising from its failure to follow current Good Manufacturing Practices (cGMP) when manufacturing sterile drug products. Former Auto Body Shop Owner Sentenced for Role in Odometer and Title Fraud SchemeUnited States v. Paul RobinsonPress Release On August 3, 2020, U.S. District Judge Kathleen M. Williams granted the government’s motion for default judgment against two Americans currently located in Colombia who lead the non-religious “Genesis II Church of Health and Healing,” in an FDCA civil enforcement action. In 2015, drugs manufactured by the pharmacy were potentially linked to a 2015 outbreak of Staphylococcus aureus infections in Rhode Island. The complaint charges that the defendants violated the Telemarketing Sales Rule (TSR) by operating a telemarketing campaign that delivered pre-recorded “robocall” messages warning consumers about a purported looming “14 percent increase” in their energy bill. Fla.). Federal civil rights law protects gay, lesbian and transgender workers, the Supreme Court ruled Monday. They were told to pay thousands of dollars to Smith and others in order to collect their winnings. 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. 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 insanity conditions included the presence of rodent excrement and mold in the production facility. 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. For more information, see the press release dated June 20, 2019. 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. MD.). Based on the evidence presented, the court found probable cause to conclude that “Defendant Maven Infotech Pvt. Following a jury trial in the Southern District of Florida, Mathauda was sentenced to 200 months’ imprisonment. Rodis’ co-defendants recruited and trained telemarketing staff to answer consumer calls, during which sales staff routinely lied to homeowners about the firm’s success rates, ability to obtain loan modifications, and, at times, directed homeowners to stop making mortgage payments. Rodis was paid for the use of his law license in an effort to lend legitimacy to the operation. 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. Despite his boasts, Trump again is no deal-maker as Congress seeks pandemic relief bill. Court Permanently Enjoins Mississippi Compounding Pharmacy and Two Individuals from Manufacturing and Distributing Adulterated Drugs United States v. Delta Pharma, Inc., et al. Tex.). Many alleged victims were elderly or otherwise vulnerable. Updated: October 28, 2020. Tex). Many victims received nothing; others received only a cheap piece of jewelry or a report listing unrelated sweepstakes. 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 letters falsely claimed recipients had won money or valuable prizes, such as luxury cars. The complaint alleges that consumers pay for items supposedly sold through the websites but never receive those purchases. It says employers may not fire or refuse to hire employees based on their race, religion, sex or national origin. La. 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. The list includes civil cases filed two weeks preceding the previous business day. Air was pushed into the clean room through the HEPA filters. According to the complaints, the defendants and their affiliates have used their products on thousands of patients without obtaining necessary FDA approvals. The consent decrees permanently enjoin the defendants from using the U.S. Mail to distribute fraudulent mailings or any mailings promoting similar schemes. The Army general in charge of getting COVID-19 vaccines to the nation apologizes for a ‘miscommunication’ over the number of doses to be delivered. NameCheap, Inc., the company that registered the fraudulent website on the defendant’s behalf, took down the site within hours of receiving the TRO entered by U.S. District Judge Robert Pitman. Cadden repeatedly took steps to shield NECC’s operations from regulatory oversight by the FDA by claiming to be a pharmacy dispensing drugs pursuant to valid, patient-specific prescriptions. Under the proposed consent decree, Downing will be enjoined from manufacturing drugs in violation of the FDCA and will be required to cease operations until FDA determines that the company has brought its conduct into compliance with the law. U.S. District Judge Robert N. Scola sentenced one of Guerra’s co-defendants to 88 months’ imprisonment in March. Court Orders Non-Religious Florida “Church” to Stop Selling Unlawful Bleach Product as Coronavirus Treatment. 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. Further, because they are prescription drugs, their labels by definition cannot bear adequate directions for use by a layperson. 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. Docket Number: 1:07-CR-20871 (S.D.Fla.). Four Individuals Charged in Clinical Trial Fraud Scheme United States v. Bencosme, et al. As part of a guilty plea, Hermoza admitted that he and other callers he supervised falsely told victims that they were attorneys or government representatives. Victims never received the promised winnings. The complaint further alleged that several of the defendants’ products were misbranded under the FDCA, in that many of the product labels did not list all ingredients or indicate the correct serving size. The fraud investigation resulted in Adrianzen’s conviction in November 2019 for conspiracy to commit mail and wire fraud. But concerns are mounting about availability. Docket Number: 6:18-CR-0004 (D. 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. After these infections, all of B. Braun’s syringes manufactured by AM2PAT were recalled. Court Enters Temporary Restraining Order Against Tech-Support Wire Fraud SchemeUnited States v. Maven Infotech Pvt. On July 25, 2018, Lawson Basnight of Norfolk, Virginia, was sentenced to serve 18 months in prison and three years of supervised release in connection with an odometer and title fraud scheme. Mich.). Former Attorney Pleads Guilty for Role in Loan Modification Scam That Targeted Struggling HomeownersUnited States v. Ronald RodisPress ReleaseDocket Number: 8:13-CR-0208 (C.D. Injunctions Entered Against Defendants in Multi-Million Dollar International Mail Fraud SchemeUnited States v. BDK Mailing GmbH, et al.Press Release Ul Haq and Saeed were arrested in England in October 2012, and held without bond until they were extradited to the United States in the spring of 2013. The Summons and Complaint in this matter may be found at this LINK. This litigation arose following eight years of FDA inspections which found that the defendants continually violated the agency’s Current Good Manufacturing Practice (“CGMP”) regulations in their sandwich production. Can a state require its appointed electors to cast their presidential ballots in the electoral college for the candidate who won the most popular support in the state? The order permanently enjoins the defendants from processing and distributing food that is adulterated under the Food, Drug, and Cosmetic Act. Supreme Court opinions are browsable by year and U.S. Reports volume number, and are searchable by party name, case title, citation, full text and docket number. Docket Number: 3:17-CR-546 (N.D. The defendants portrayed the companies as law firms and attorney-based companies that would negotiate favorable credit card settlements on behalf of consumers. As alleged in the information, between March 5 and 15, 2011, nine patients at various Birmingham-area hospitals who developed bloodstream infections caused by S. marcescens died, and several other hospital patients developed S. marcescens bloodstream infections but survived. BEK prepared, processed, packed, and distributed ready-to-eat seafood products, namely seafood soups sold under the names Shrimp Locksley and Mama’s Gumbo. Docket Number: 1:17-CR-0109-MOC-DLH (W.D. Two Peruvian Men Plead Guilty in Call Center Extortion Scheme 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. The defendants agreed to be bound by a consent decree in which they stated that they no longer manufacturer or process fish or fishery products, and only distribute prepackaged items. 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 animal’s genome as a new animal drug. The charge against Gore carries a statutory maximum penalty of 5 years in prison. Docket Number: 6:18-CV-0389 (M.D. On June 24, the district court entered a consent decree of permanent injunction against Wa Heng Dou-Fu & Soy Sauce Corporation and the firm’s co-owners, Peng Xiang Lin and Yuexiao Lin, to prevent the distribution of adulterated and misbranded soy products. Woman Pleads Guilty to Conspiracy to Commit Money Laundering in Connection with International Lottery SchemeUnited States v. Samaiyah ArmisteadPress Release Ark.). Del.) Despite the fact that the company had told the FDA that the Stratus was intended to maintain an opening to a patient’s sinus, Facteau and Fabian launched the product intending it to be used as a steroid delivery device. According to the charges, all of these patients had been given TPN that was compounded and distributed by Meds IV. Trial for the remaining defendants is scheduled to begin June 13, 2017. As part of his guilty plea, Guerra admitted that he and others in Peru called victims in the United States claiming to be attorneys or government representatives. Complaint Filed Against New York Food Distributors Alleging Insanitary ConditionsUnited States v. Euroline Foods, LLC, et al.Press Release Armistead received $7,500 in cash from a victim in Maryland and deposited most of that money into accounts of a co-coconspirator. Our current cases reflects our unwavering commitment to progressive principles, people’s movements and human rights as well as our creative use of the law as a positive force for social change. Yabe is scheduled to be sentenced on March 27. See February 17, 2017 update on Felecia Lindo. Tex.). The entry of the permanent injunction resolves the litigation. 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 trial date has not yet been set. Docket Number: 1:18-CV-1121 (E.D.N.Y). Is a direct pay offer to employees over the head of the union unlawful? International Mass-Mailers Enjoined from Further Participation in Fraudulent Solicitation SchemesUnited States v. Alexander Quaglia, et al. Another co-conspirator, Omar Portocarrero Caceres, previously was sentenced to 46 months. On February 19, 2016, Joseph Dallal was sentenced to serve 33 months in prison in connection with two separate prescription drug diversion schemes. In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the FDCA. These recent efforts signal a recognition by administrative and chief judges that litigants and their counsel may need to remain at home for several more weeks or months and that case-related business must proceed remotely to avoid a backlog of cases later this year. Some high-profile cases are due in Calgary court in 2020 and, of the six highlighted below, three involve child victims. Donald Trump was elected partly on his fame for “The Art of the Deal,” yet he’s cut no big deals in office. Press Release … 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. Simpson's legal troubles didn't end after he was … The government alleged in a February complaint that Navigator Marketing Ltd., a Canadian company, and Rockport Promotional Marketing, LLC, a Delaware registered corporation, and the corporations’ principals, Alexander Quaglia, Rychard McKeown, and Brent Nishiguchi, all of British Columbia, Canada, operated an international fraud scheme that mailed solicitations informing recipients that they would receive large sums of money after payment of a small fee. Cal.). Otherwise you are just throwing a tantrum. From July 2008 until May 2012, Marks made sales from an office in Brooklyn, New York, on behalf of U-Turn Vending, which was based in Idaho. 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. As charged in the information, amino acid used in compounding the TPN was adulterated in that it was contaminated with Serratia marcescens (S. marcescens) and was prepared, packed, or held under insanitary conditions. Press Release According to an indictment returned last October, Xu agreed with a confidential government informant to mislabel synthetic stimulants arriving in the United States or otherwise help to hide from retailers the true nature of a proposed new dietary supplement. § 1345 against three John Doe defendants connected to a fraudulent sweepstakes scam. He also pleaded guilty to charges brought by the Narcotics and Dangerous Drugs Section of the Criminal Division related to his sale of methamphetamine precursor chemicals. She turned to prostitution and regularly left her five children to binge on drugs. This case was initiated in 2011, alleging that the defendants, Feature Films for Families, Inc., Corporations for Character, L.C., Family Films of Utah, Inc., and Forrest S. Baker III, committed widespread violations of the FTC Act and Telemarketing Sales Rule (TSR) in various telemarketing campaigns to sell DVDs and movie tickets, and in charitable solicitation call campaigns. U.S. Supreme Court Recent Cases. 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. The callers threatened victims with negative credit scores, imprisonment, deportation, or seized property if they refused to immediately pay “settlement fees.”  Guerra and two co-defendants were arrested in Peru and extradited in 2019. These infections can cause serious medical complications, including death, because S. marcescens is resistant to many antibiotics. On November 4, the United States filed an injunction action against Scilabs and Edalat seeking this relief. Second Circuit Affirms Conviction and Sentence of Business Opportunity FraudsterUnited States v. Edward Morris "Ned" Weaver (Vendstar) Press Release 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. As alleged in the government’s complaint, the defendants called and sent letters to consumers falsely claiming that the consumers had won hundreds of thousands of dollars in a sweepstakes. Akinyoyenu admitted that after the doctor approved the website orders from his home in Florida, Akinyoyenu would ship the pharmaceuticals from his brick-and-mortar pharmacy in Washington, D.C. Akinyoyenu admitted that the drugs lacked valid prescriptions, and therefore were misbranded, when shipped. Civil Special Appeal No. On May 27, 2020, U.S. District Court Judge Ronald A. Docket Number: 15-10399 (11th Circuit) On October 21, 2019, the District Court permanently enjoined two additional defendants in connection with three prize promotion schemes that primarily impacted elderly or vulnerable victims. Victims who send payments receive no prize. No, the court said in a 5-4 ruling in June Medical Services vs. Russo. Cal.). On December 6, 2018, the Court of Appeals for the Second Circuit affirmed the convictions and sentences of five defendants who worked at Vendstar, a Long Island company that brought in more than $60 million from selling worthless candy vending machine business opportunities. On July 23, 2020, Utah resident Gordon H. Pedersen was indicted on wire fraud, mail fraud, and drug misbranding charges in connection with an alleged scheme to fraudulently sell a purported COVID-19 treatment. This page lists current CPB case updates accessible to the public. Permanent Injunction Entered Against Vermont Dairy FarmUnited States 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.). Lawrence A. Kaplan, who was Vendstar’s technical support manager, a position in which he stifled complaints to keep the scheme going, was sentenced to 54 months in prison. In a July 2017 complaint, the government alleged that the defendants promoted and sold misbranded sexual enhancement products that contained the undisclosed ingredient sildenafil, which is the active pharmaceutical ingredient in Viagra. On May 13, 2020, Blue Bell Creameries pleaded guilty before U.S. District Judge Robert Pitman to charges that the Texas-based ice cream manufacturer shipped listeria-contaminated products in 2015. This, ESN alleged, violated the Civil Rights Act of 1866, codified at 42 U.S.C. The list is updated each day at approximately 12:00 pm. Mich.). District Court Issues Preliminary Injunction Against Federal Trade Commission Impersonators in Sweepstakes Scheme, United States v. John Doe 1, et al. Hensley v. Montana State Fund Date: December 16, 2020 Citation: 2020 MT 317 Docket Number: DA 19-0523 . 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. As part of the permanent injunction, the district court ordered equitable disgorgement with refunds to consumers to be administered by a court-appointed special master. In affirming the district court’s decision, the Court of Appeals held that the statute of limitations for such a violation does not begin to run until a company finally files the required report, and that the Act allows courts to impose forward-looking injunctive relief. Tenn.). Mich.), Court Enters Injunction Against Seafood Manufacturer in California. In a complaint filed on September 20, the United States alleged that Parrish violated the Food, Drug, and Cosmetic Act by causing ready-to-eat caviar to become adulterated by being prepared, packed, or held under insanitary conditions. 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. 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. Both defendants were charged in a 14-count indictment alleging a five-year identity theft scheme that targeted servicemembers and veterans. Docket Number: 3:16-CR-313-RJC (W.D.N.C.). 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. One of his co-defendants will be sentenced in April, and another co-defendant is set for trial later this spring. In February 2012, a Michigan hospital traced infections among 16 surgical patients to a specific gel made by Pharmaceutical Innovations. Jury Convicts Defendants in Medical Device CaseUnited States v. William Facteau and Patrick FabianPress ReleaseDocket Numbers: 1:15-CR-10076 (D. 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. In total, 15 defendants named in a November 2018 complaint now have been permanently enjoined from engaging in fraudulent mailings. Robinson also was ordered to pay $320,797.82 in restitution to the victims of the scheme. Restitution will be decided at a later hearing. During that period, the Supreme Court reversed a lower court decision 650 times (70.3 percent) and affirmed a … Cal.). 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. Press release Docket Number: 1:16-CR-0450 (D. Fla.). As a result of a previous court order, the statements currently are running on television five times per week, and previously ran as full-page ads in about fifty newspapers across the country. On August 2, 2018, Karen Turner was sentenced to nine months in prison for wire fraud and money laundering in connection with two fraudulent pharmacies that Turner used to divert prescription drugs into the gray market. Long did not have authorization to charge any of these victims’ accounts. Mill Stream Corporation processed and distributed a variety of refrigerated, vacuum-packed, ready-to-eat, cold and hot smoked fish or fishery products such as smoked salmon, trout, and char. Welcome to FindLaw's searchable database of U.S. Supreme Court decisions since 1760. 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. As alleged in the information, Meds IV compounded various drugs for human use, including an intravenous drug known as Total Parenteral Nutrition (TPN). United States v. Neptune Manufacturing, Inc., et al. The Seventh Circuit upheld the lower court’s ruling here in May 2019. 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. The Supreme Court agreed Wednesday to take up an appeal by the National Collegiate Athletic Association to a lower court ruling that allows colleges to … 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. He agreed that lawmakers in 1964 may not have intended to protect gay, lesbian, bisexual, transgender or queer employees, but he said the court relies on the words of the law, not the aims of the lawmakers. Tex.). David G. Savage has covered the Supreme Court and legal issues for the Los Angeles Times in the Washington bureau since 1986. Through multiple websites, the defendants promoted the “miracle solution” as a cure and treatment not only for COVID-19 but also for other serious diseases ⸺ including Alzheimer’s, autism, brain cancer, HIV/AIDS, and multiple sclerosis. 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