1345 against Maven Infotech Pvt. Cal. MediNatura challenges FDAs withdrawal of an enforcement-discretion policy for homeopathic drugs and the agencys addition of MediNaturas products to an import alert. The court sentenced Bearden to five months imprisonment followed by three years of supervised release, the first five months of which will be home detention. On February 5, 2021, Maytee Lledo pleaded guilty to conspiracy to commit wire fraud in connection with an scheme to falsify clinical trial data. The former president says the claim is a lie. In pleading guilty, Bencosme admitted that she, as principal investigator at Unlimited Medical Research, 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. On March 3, 2021, U.S. District Judge Edward R. Korman enjoined dietary supplement firm Confidence USA and its operators from continued violations of the Food, Drug, and Cosmetic Act. 1:20-cr-20190(S.D. Jury selected for E. Jean Dailey pleaded guilty on January 8, 2019 to one count of introducing misbranded drugs into interstate commerce and one count of importing merchandise contrary to law. Sixteen other defendants pled guilty. On February 21, 2017, the Court of Appeals for the Eleventh Circuit affirmed the sentence of Sirtaj Tosh Mathauda, who was convicted of conspiracy and multiple counts of mail and wire fraud in connection with a series of fraudulent business opportunities. Like other so-called caging services, Trends and KSB open the payment envelopes, remove the contents, enter payment and other personal information from the victims into a database, and handle victim payments. Docket Number: 15-16844 (9th Cir./N.D. Chief Executive Officer and Manager of Fraudulent Business Opportunity Seller Sentenced to PrisonUnited States v. Edward WeaverPress Release Judge Chhabria also ruled that FDAs guidance pertaining to genetically engineered animals cannot be challenged because it does not have direct and appreciable legal consequences, and therefore does not constitute final agency action. The complaint alleges that the two rural pharmacies are among the highest purchasers of opioids per capita in the entire country. District Court Permanently Enjoins 15 Individuals and Companies in Elder Fraud Mail Scheme Summary Judgment Granted Against Manufacturer of Adulterated Dietary Supplements. Supplement Company that Touted Silver COVID-19 Treatment Agrees to Permanent Injunction and Consumer Refunds, United States v. My Doctor Suggests LLC According to the complaints, the defendants and their affiliates have used their products on thousands of patients without obtaining necessary FDA approvals. 1, 2018, filed a motion seeking a preliminary injunction against Cantrell Drug Company and its co-owner and Chief Executive Officer, James L. McCarley, Jr., to stop the manufacturing and distribution of adulterated drugs. The complaints were filed by the U.S. Attorneys Office for the Northern District of Ohio and the Consumer Protection Branch. Docket Number: 2:19-CV-111 (W.D. United States v. Palacio, Case No. Working with her co-conspirator in Jamaica, Palmer recruited a friend in Maryland to receive $7,500 of the victims money. Defendant Shevin Goodman pled guilty in 2008 to conspiracy to commit mail fraud in violation of 18 U.S.C. Jury Finds All Defendants Liable in Utah Telemarketing CaseUnited States v. Feature Films for Families, Inc., et al.Docket Number: 2:12-CV-0811 (D. Utah). On July 9, 2020, U.S. District Judge Kathleen M. Williams granted the governments motion for default judgment against the Genesis II Church of Health and Healing, along with two of the non-religious entitys four principals, Jordan Grenon and Jonathan Grenon, who were located in the United States. 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 quick answer is: it depends. 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. U.S. District Judge Robert N. Scola sentenced one of Guerras co-defendants to 88 months imprisonment in March. Florida Company Enjoined from Distributing Misbranded and Adulterated Medicated FeedsUnited States v. Syfrett Feed Company, Inc., et al.Press Release District Court Finds Websites to be Labeling Under FDCA in Denying Motion to Dismiss Enforcement ActionUnited States v. Innovative BioDefense, Inc. et al. On December 19, 2019, Johnny Hidalgo, Rodolfo Hermoza, and Francesco Guerra were extradited from Peru to face charges of conspiracy to commit mail and wire fraud, mail fraud, wire fraud, and extortion in the Southern District of Florida. 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. The complaint alleged that the schemes generated approximately $4.8 million in annual victim losses. Sitesh Patel, the vice president of S.K. Court Permanently Enjoins Texas Ready-to-Eat Fish Processor and Three Individuals from Processing and Distributing Adulterated FoodUnited States v. Topway Enterprises, Inc., et al. Docket Number: 2:16-CR-0262 (D. Nev.). This rule provides that the first step in an action is the filing of the complaint. Docket Numbers: 1:14-cr-75 & 1:12-cr-489. Cal.) 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. Tex.). The defendant is presumed to be innocent until proven guilty beyond a reasonable doubt in a court of law. Many victims received nothing; others received only a cheap piece of jewelry or a report listing unrelated sweepstakes. Some states have statutes that allow longer limitation periods for civil lawsuits resulting from criminal conduct, including Victims never received the promised winnings. For PDFs, the actual number of pagesis counted (1 PDF page = 1 billable page). Depending on format, billable pages are calculated in two different ways. Turner also admitted that after her first fraudulent pharmacy was closed for drug diversion, she started an identical drug diversion scheme in a neighboring state. In a complaint filed with the consent decree, the United States alleged that the fish at defendants facility was processed under insanitary conditions, chiefly because the defendants failed to adequately control the growth of Listeria monocytogenes. Docket Number: 2:19-CV-9 (M.D. Pa.). Court Orders Dish Network to Pay $280 million for Illegal Telemarketing CallsUnited States v. Dish Network, LLC Press Release The complaint and consent decree follow FDAs July 2019 administrative decision to suspend the defendants food facility registration. However, B. Braun resumed buying syringes from AM2PAT without going to the new facility, and despite receiving new information showing that AM2PAT moved manufacturing equipment into its new facility without validating that the equipment worked as expected. Mathauda also appealed the courts denial of his motion to proceed pro se, arguing that he had made a clear and unequivocal request to proceed pro se before his sentencing and that the denial of the motion without a hearing violated his Sixth Amendment right to self-representation. During the last five years it was open, Vendstar made approximately $62 million in sales. Victims sent money to mailboxes located in the United States and received no cash prizes. As the trial began, his lawyer called her lawsuit a plan to make her famous. Mo.). Pedersen allegedly posed as a doctor to promote ingestible silver-based products as a cure for COVID-19 despite having no evidence that his products could treat the disease. The United States alleged in a complaint filed January 26 that WeCare Pharmacy, its pharmacist owner Qingping Zhang, pharmacy technician Li Yang, and another related corporate entity, L&Y Holdings LLC, repeatedly dispensed opioids in violation of the Controlled Substances Act. 1:20-cr-49 (W.D. );1:14-CR-10 (S.D. These solicitations, mailed from locations around the globe, purport to be personalized to each individual recipient, despite the fact that they are form letters mailed to hundreds of thousands of potential victims. The coordinated U.S. and Dutch actions immediately stopped defendants from using the Dutch boxes to receive future payments from fraud victims and from further victimizing elderly Americans. Because Acino has never submitted an application for FDA approval of the drugs, they have never been found to be safe and effective. Ressler also agreed to a civil consent order, filed Feb. 21 with in the Eastern District of New York, that enjoins him from involvement in further fraudulent solicitation schemes. On October 17, Samaiyah Sharron Armistead pleaded guilty in U.S. District Court for the District of Maryland to one count of conspiracy to commit money laundering. Mich.). 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. The defendants were executives of Acclarent, a start-up company that was acquired by Johnson & Johnson in 2010. Evidence at trial showed PCA products sickened hundreds and likely thousands of people during an outbreak of salmonellosis in 2008-09. United States v. Neptune Manufacturing, Inc., et al. This is the first enforcement action under the CCPA. Weaver and Kaplan were ordered to report to prison on January 9, 2017. Harkonen argued that his conviction should be overturned because his trial team failed to call any expert witnesses for the defense. The court also observed that even if it had jurisdiction to consider plaintiffs challenge to the FDA guidance document, the plaintiffs request to enjoin FDA from conducting an enforcement action was an impermissible attempt to test a defense pre-enforcement. Another consent decree entered in that case on March 2 barred defendants Jon Kahen, Global Voicecom, Inc., and Global Telecommunication Services Inc. from conveying recorded telephone calls, directing calls into the United States from overseas, and originating calls within the United States. The complaint further alleges that the defendants issued numerous purported prescriptions without a legitimate medical purpose and outside the usual course of professional practice to undercover agents of the United States Drug Enforcement Administration. Altogether, 22 individuals were convicted of fraud in connection with Vendstar. The cost to access a single document is capped at $3.00, the equivalent of 30 pagesfor documents and case-specific reports like docket report, creditor listing,andclaims register. Docket Number: 0:18-CV-0532 (D. Minn.). The charge is not based on printing that search or document. Docket Number: 2:14-cr-126. In pleading guilty earlier this year, Ryan admitted that from 2007 through 2010, he unlawfully authorized more than 158,000 website prescription drug orders, including orders for Fioricet, which contains the controlled substance butalbital, and two drugs that later went on DEAs controlled substances list, Soma and tramadol. District Court Issues First-of-its-Kind TRO to Stop Tennessee Pharmacies and Pharmacists from Dispensing OpioidsUnited States v. Oakley Pharmacy, Inc. et al. 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. Docket Number: No. Tex.). MediNatura recently filed a second motion for preliminary injunction pending appeal, claiming that it was likely to succeed on the merits of the dismissed import alert claims due to changed circumstances. Nine New Yorkers were selected on Tuesday for a trial in a lawsuit brought by the writer and columnist E. Jean Carroll accusing Eubank, who operated an automobile electronics repair shop in Midlothian, Virginia, acknowledged that between 2010 and 2016, he used various electronic tools to access motor vehicle odometers to lower the odometer readings of hundreds of vehicles. 331(d) and 333(a)(2). A third individual, Clifford Woods, pled guilty on May 9, 2016, in the U.S. District Court for the Central District of California to a misdemeanor FDCA violation for distribution of unapproved new drugs that he marketed and sold as treatments for cancer and other diseases. He instructed consumers to combine MMS with citric acid to create chlorine dioxide, add water and drink the resulting mixture to cure numerous illnesses. The solicitations misled recipients into believing that they would receive large sums of money or powerful talismans for payments of $50 to $55. Alabama Seafood Soup Producer Signs Consent Decree in Connection with Distribution of Adulterated and Misbranded FoodUnited States v. BEK Catering, LLC d/b/a Floppers Foods, et al. A company without a food facility registration cannot distribute any food products. Indian Cancer Drug Manufacturer Sentenced for Concealing and Destroying Records in Advance of FDA Inspection. The Court also found no reversible error related to the district courts loss calculations at sentencing, and ruled against the defendants on various evidentiary claims and other arguments. Defendants Appeal Dismissed in QLaser Medical Device Scam United States v. Robert Larry Lytle et al. NOTE: If you accrue $30 or less of charges in a quarter, fees are waived for that period. Find a Case (PACER) | United States Courts Court Rules in Favor of Government in Challenge to FDA Guidance Document Lystn, LLC, d/b/a Answers Pet Food v. FDA, et al. On June 29, Ronald Rodis pled guilty to conspiracy to commit mail and wire fraud for his role in Rodis Law Group, a bogus law firm that purported to offer struggling homeowners assistance obtaining loan modifications. Lindo was also ordered to pay $292,900 in restitution. 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. Fraudulent Call Center Operator Pleads Guilty to Overseeing Call Centers that Threatened and Defrauded Spanish-Speaking Consumers. 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. 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. case South Dakota Man Pleads Guilty in QLasers Medical Device ScamUnited States v. Ronald D. Weir, Jr. Press Release In the course of authorizing drug orders for RX Limited, the defendant had no face-to-face contact with customers, performed no mental or physical examinations, did not take patient histories or perform any diagnostic or laboratory testing, did not check the accuracy of the information customers provided, and did not monitor, or provide any means to monitor, medication response. Cal.). Ga.), District Court Rules for Government in Action Against Cheese Manufacturer, Docket Number: 2:14-CV-13077 (E.D. In a statement of facts, Epsilon admitted that its employees sold consumer data to clients engaged in fraud despite knowing that those and similar clients had been arrested, charged with crimes, convicted, and were otherwise subject to law enforcement actions for false and misleading practices. 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. Summons and Complaint -- When the United States Attorney decides a federal civil law has been violated, a civil litigator, known as an Assistant U.S. Attorney, files a Summons and Complaint in U.S. District Court and has a copy of the documents served on the alleged offender, who is called the defendant. Victims received telephone calls informing them that they had won more than one million dollars in a lottery, but that they needed to pay advance fees to claim their winnings. 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.). ), Defendant Pleads Guilty in Vending Machine Business Opportunity Case. On April 26, 2019, the Eighth Circuit Court of Appeals granted the governments motion to dismiss an appeal brought by a defendant convicted of marketing and selling light-emitting medical devices as a cure-all to (primarily elderly) consumers.