District Court Issues Temporary Restraining Order against Las Vegas Defendants in Direct-Mailing SchemeUnited States v. Kern, et al. Blue Bell Creameries Sentencing Date Set in Listeria Contamination Case, United States v. Blue Bell Creameries 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. Permanent Injunction Entered Against Seller of Dietary SupplementsUnited States v. Bethel Nutritional Consulting, Inc., Felix Eamirez, and Kariny Ramirez, Press ReleaseDocket Number: 2:15-CV-8046 (D.N.J.). The indictment alleges that over a five-year period, members of the conspiracy exploited personal identifiers of military members to steal millions of dollars. Pa.). OxyElite Pro was recalled in 2013 after being linked by the Food and Drug Administration to a deadly outbreak of serious liver injuries. Young worked with a co-conspirator named Ercan Barka, who pleaded guilty to the same charge in January. Specifically, the complaint alleges that the defendants routinely dispensed controlled substances while ignoring numerous warning signs of diversion and abuse, such as unusually high dosages of oxycodone and other opioids, prescriptions for opioids and other controlled substances in dangerous combinations, and patients travelling extremely long distances to obtain and fill prescriptions. 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. Press Release 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 statements address the effects of cigarette smoking and the fact that cigarettes are deliberately designed to create and sustain addiction. 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. Army general apologizes for ‘miscommunication’ over vaccine shipments. Dietary Supplement Companies Sentenced in Case Involving Alleged Link to Liver Damage, U.S. v. USPLabs, et al. The complaint, filed with the consent decree on Dec. 18, 2017, alleged that until 2012, Dr. Reddy’s distributed oral prescription drugs in blister packaging that it failed to test for child resistance under the Poison Prevention Packaging Act. Intel., Inc. v. Donahue, … The website stated that kits would be sent in exchange for a $4.95 shipping charge, which consumers would pay by providing credit card billing information. The indictment alleged that the defendants misrepresented the nature and origin of the active ingredients in their products. 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. 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 defendants agreed to be bound by a consent decree of permanent injunction filed with the complaint. On May 10, 2017, pharmacist Titilayo Akinyoyenu was sentenced to 36 months of probation and ordered to pay a $250,000 criminal fine for his role in a conspiracy to ship pharmaceuticals that were misbranded because they lacked valid prescriptions. The announcements confirm settlements for violations of the Stark Law, a federal anti-self-referral law and the Anti-Kickback Statute (AKS). Both defendants were charged in a 14-count indictment alleging a five-year identity theft scheme that targeted servicemembers and veterans. Fla.). The complaint alleged that the defendants continued to make such claims in violation of the Food, Drug, and Cosmetic Act despite receiving a March 6 joint warning letter from the Food and Drug Administration and the Federal Trade Commission. Defendant Pleads Guilty in Multimillion-Dollar Prize-Promotion ScamUnited States v. Lovisa, Press Release Victims never received any lottery winnings. Deputy Directors for Litigation, 8:14-CR-0198-DSF; 8:15-CR-0041 (C.D. Civil Penalty and Permanent Injunction Entered Against Dr. Reddy’s Laboratories, Inc. Related to Child-Resistant Drug PackagingUnited States v. Dr. Reddy’s Laboratories, Inc.Press ReleaseDocket Number: 3:17-CV-13219 (D.N.J.). Otherwise you are just throwing a tantrum. The complaint alleged the schemes targeted the elderly and generated approximately $4.8 million in annual victim losses. The CDC did not identify any deaths related to the outbreak. 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. ); 2:15-CV-8889 (C.D. Cal.). 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. On November 12, 2014, the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Scilabs Nutraceuticals, Inc., of Irvine, California, and its board chairman and chief executive officer, Paul P. Edalat, to prevent the distribution of adulterated dietary supplements in interstate commerce. The complaint alleges that the defendants are in violation of current good manufacturing practice and quality-system requirements, and are marketing medical devices without either clearance or approval. On Feb. 13, 2018, Ryan Young pleaded guilty to one count of conspiracy to commit mail fraud for his role in a large-scale international mail fraud scheme that brought in $50 million from victims between 2011 and 2016. Blue Bell Creameries Pleads Guilty in Ice Cream Listeria Contamination Case, United States v. Blue Bell Creameries No-Poach’ Agreements. 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. The complaint alleged that ABH and Islam manufactured and distributed dietary supplements under conditions that failed to comply with current good manufacturing practice regulations. On October 6, 2017, Jonathan Wall was sentenced to probation and Onochie Aghaegbuna was sentenced to time served related to their roles in RX Limited, a fraudulent Internet pharmacy scheme. Apex shipped prescription drugs, including addictive pain medications such as Fioricet, Soma, and Tramadol, to customers from across the United States who submitted orders and filled out online medical questionnaires. Smith created phony “water purification” and “wastewater treatment” businesses in order to obtain sodium chlorite and ship his MMS without being detected by the FDA or U.S. Customs and Border Protection. 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. A recent court case has opened up a legal strategy for parents who object to pro-transgender language in elementary school curricula. Cal.). As the number of deaths caused by coronavirus climbs in America, new civil liberties dilemmas have emerged for governments trying to protect public … Facebook Ordered to Pay $5 Billion Civil Penalty and Implement Enhanced Consumer Privacy Protections, United States v. Facebook, Inc. Based on the evidence presented, the court found probable cause to conclude that “Defendant Maven Infotech Pvt. 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. Sentencing is set for March 26, 2019. Court Denies Indivior's Motion to Dismiss Indictment Alleging Illegal Opioid Marketing Mexico and Chile are among the Latin American nations planning to roll out COVID-19 vaccines this month. On January 16, 2020, the court granted the government’s motion to dismiss for lack of subject matter jurisdiction in a challenge to an FDA guidance document concerning the presence of Salmonella in food for animals. Docket Number: 1:16-CV-5264 (E.D.N.Y.). U.S. District Judge Louis Guirola Jr. sentenced Oscar M. Baine, 42, to 36 months’ incarceration and ordered him to pay $619,200 in restitution. 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. Docket Number: 8:18-CV-996 (C.D. 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