Under the terms of the agreement, B. Braun will increase oversight of its product suppliers by conducting on-site audits of companies that design and make finished products that bear the B. Braun name on the label or logo and testing such products for sterility, identity and purity, as appropriate, on a periodic basis. Chicago Dietary Supplement Companies Ordered to Comply with FDCA United States v. Global Marketing Enterprises, Inc., et al.Press Release However, according to a criminal Information filed Sept. 22, 2017, Aegerion failed to give health care providers complete and accurate information about HoFH and distributed Juxtapid as a general treatment for high cholesterol without adequate directions for such use. On February 22, 2019, Judge David Carter denied defendants motion to dismiss the United States complaint, finding that statements on websites can constitute drug labeling under the Food, Drug, and Cosmetic Act (FDCA). TRO Entered Against Mass-Mailing Fraud Schemes Targeting the Elderly United States v. Trends Service, et al. Docket Number: 1:17-CR-00113 (S.D. Sonar, a New Jersey corporation, manufactures drugs for Stratus. Find court specific information to help you file a case electronically and developer resources. Six defendants were convicted of conspiracy, mail fraud, and wire fraud charges following trial in 2015. NameCheap, Inc., the company that registered the fraudulent website on the defendants behalf, took down the site within hours of receiving the TRO entered by U.S. District Judge Robert Pitman. District Court Enters Preliminary Injunctions Against Texas Doctors Who Prescribed Opioids With No Legitimate Medical PurposeUnited States v. Cesar B. Pena Rodriguez, M.D., and Leovares A. Mendez, M.D. The Court granted summary judgment in favor of the government in January. A hearing for the defendants to show cause why a preliminary injunction should not issue is scheduled for April 24, 2018. United States v. Christopher Reyes, Case No. Docket Number: 1:18-CV-04689-ENV-CLP (E.D.N.Y.). 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. 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. 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. The remainder will be distributed among the settlement member states in alignment with terms of the agreement. Court Permanently Enjoins Canadian Mass-Mailers From Sending Fraudulent Solicitations United States v. Thomas, et al. On Jan. 23, 2018, the 11th Circuit Court of Appeals affirmed the convictions and sentences of three defendants found guilty of fraud and other charges related to the distribution of contaminated peanuts and peanut products by Peanut Corporation of America. Three Individuals Charged With Distribution of Unapproved DrugsUnited States v. Guy Lyman; United States v. Flor Nutraceuticals, LLC and Guy Lyman; United States v. James Hill; United States v. James Hill d/b/a Viruxo LLC; United States v. Clifford Woods; United States v. Clifford Woods LLC d/b/a Vibrant Life and Clifford Woods Press ReleaseDocket Numbers: 2:16-CR-0124 (E.D. District Court Orders PharMedium Compounding Pharmacy and Two Executives to Comply with Drug Safety Standards United States v. PharMedium Services LLC, et al. Civil Lawsuits for Criminal Conduct. Laboratories, a California dietary supplement manufacturer, pleaded guilty to conspiracy to introduce misbranded food into interstate commerce and to the introduction of misbranded food into interstate commerce. 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. At the time of their sentencings, both defendants had been incarcerated for approximately 4 years, including time spent in an English jail. WebA motion to dismiss is a formal request for a court to dismiss a case. Each defendant was charged with conspiracy to commit mail and wire fraud and at least one substantive count of mail fraud. United States v. Bencosme, et al. 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. On Feb. 21, 2018, Sherry Gore was charged with conspiring to use a false name in connection with a fraud scheme for her role collecting money for a long-running psychic mail fraud scam. The indictment alleges that Adrianzen provided payment processing and shipping services for the call centers, knowing that they used fraudulent and extortionate means to extract money from victims. Read the fee schedule for electronic public access services. There are definite time limits regarding how late you can file a lawsuit after a triggering event. The injunction follows a temporary restraining order entered on allegations that the defendants sent fraudulent notifications to consumers promising large cash prizes pending payment of small fees. The consent decree subjects the defendants to heightened FDA oversight and requires them to cease all operations until the defendants implement a number of new record-keeping and operational protocols designed to ensure consumer safety. Burnetts co-defendant, Amber McLaughlin, was sentenced to serve 12 months in prison and pay $176,725 in restitution. Docket Number: 1:17-CV-03751; 1:17-CV-03752 (E.D.N.Y.). 1345) against Michael Travalino to stop him from marketing herbal remedies as purported treatments for COVID-19 and other serious medical conditions. Two months after B. Braun started selling syringes manufactured at the new AM2PAT facility, B. Braun recalled all of the syringes because the radiation sterilization process caused dangerous white particles to develop in the saline inside the syringes. The court previously entered a similar consent decree of permanent injunction on July 12 against Lily Popular Varieties & Gifts, Inc., Great Great Corporation, and their owners and operators Li Jing and Cheng Feng You. Docket Number: 5:18-CR-20751 (E.D. The Court also imposed strong injunctive relief against Dish to prevent future violations. On May 20, 2015, the United States filed a criminal Information against ConAgra Grocery Products LLC, a subsidiary of ConAgra Foods Inc., alleging that the company introduced peanut butter contaminated with salmonella into interstate commerce in 2006. 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. At times, telemarketers directed homeowners to stop making their mortgage payments. He purchased high-mileage vehicles, then caused the vehicles odometers to be altered to reflect fraudulent, low-mileage readings. Docket Number: 6:20-cv-140 (E.D. In addition to two years imprisonment, Judge Judith E. Levy also sentenced Dailey to three years of supervised release. 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). Bearden, the former compliance director of Pharmakon Pharmaceuticals, Inc. (Pharmakon), of Noblesville, Indiana, pleaded guilty in November 2017 to conspiracy and nine counts of adulterating drugs. 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. In pleading guilty, Bearden admitted that she and her co-defendant, Paul J. Elmer, Pharmakons former president, lied during multiple FDA inspections about test results concerning under- and over-potent compounded sterile drugs manufactured by Pharmakon and distributed to hospitals nationwide. A jury was selected Tuesday in E. Jean Carrolls rape lawsuit in a New York federal court. Docket Number: 1:07-CR-20871 (S.D.Fla.). Va.). This page lists current CPB case updates accessible to the public. Docket Number: 1:21-cr-00006-RM (D. Colo.). 2:21-cr-20 (D. Nev.). From 2006 to 2010, Akinyoyenu owned and operated an internet pharmacy called Apex Online Pharmacy. 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. Eleventh Circuit Affirms Sentence of Business Opportunity FraudsterUnited States v. Sirtaj Tosh Mathauda 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. Sixteen other defendants pled guilty. Gao was the supply chain manager for a Chinese firm that sold raw ingredients for use in dietary supplements. A jury was selected Tuesday in E. Jean Carrolls rape lawsuit in a New York federal court. Docket No. On June 19, 2019, four individuals were charged in connection with an alleged scheme involving payments from victims of numerous international mass-mail fraud campaigns. On April 29, 2021, the Consumer Protection Branch filed a pre-settled complaint referred by the FTC against Utah-based Vivint Smart Home. The government alleged that Bencosme and the other defendants 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. For other matters of interest, see: CLOSED CASES or ARCHIVED CASE SUMMARIES. The hearings will be held in Dallas before U.S. District Judge Sam A. Lindsay. White entered a temporary restraining order against an Oklahoma company that touted an unapproved colloidal silver product as a COVID-19 treatment. 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. Ronald Rodis was paid for the use of his law license in an effort to lend legitimacy to the operation. The court previously entered a default judgment against the entity and two principals located in the United States. Second Circuit Affirms Conviction and Sentence of Business Opportunity FraudsterUnited States v. Edward Morris "Ned" Weaver (Vendstar) Press Release 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. 18-1785 (7th Cir.) Trial in the case, originally set for May, was continued to September 2020 because of the ongoing public health emergency. Docket Number: 3:18-CV-331 (N.D.N.Y.). Reyes is charged with importation of drug paraphernalia, conspiracy to violate the Controlled Substances Act, and smuggling. 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. On Dec. 4, 2017, the Ninth Circuit Court of Appeals affirmed the district courts denial of Dr. W. Scott Harkonens coram nobis petition seeking to overturn his fraud conviction for ineffective assistance of counsel at trial. On March 28, 2016, the district court granted the United States motion for summary judgment against defendants Scottys Inc. and its co-owner and manager Sandra J. Jackson, sellers of adulterated ready-to-eat sandwiches. In April 2015, Wasmunds former employer, Quality Egg, was ordered to pay a fine of $6.79 million for the felonies of bribing a USDA inspector and selling restricted and misbranded eggs with intent to defraud, and the misdemeanor of selling and shipping adulterated eggs into interstate commerce. They were told to pay thousands of dollars to Smith and others in order to collect their winnings. The complaint alleged that, over a period of several years, the defendants dispensed highly addictive and highly abused prescription opioids while ignoring red flags that is, obvious indications of drug diversion and drug-seeking behavior. Tex.). 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. The letters falsely claimed recipients had won money or valuable prizes, such as luxury cars. Following a 6-week jury trial, each defendant was convicted of 10 counts of introducing adulterated and misbranded medical devices into interstate commerce. Fla). On January 8, 2021, Dr. Yvelice Villaman Bencosme pleaded guilty to conspiracy to commit wire fraud in connection with an alleged clinical trial fraud scheme at a Miami clinical research company, Unlimited Medical Research. Docket Number: 5:17-CR-50022 (D.S.D.). The defendants admitted that the scheme resulted in consumer losses of more than $550,000. MediNatura v. FDA, 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. Biocompatibles was sentenced to pay an $8.75 million criminal fine and a criminal forfeiture of $2.25 million. On Nov. 14, 2017, the Ninth Circuit Court of Appeals affirmed the conviction of Louis Daniel Smith, who is serving a 51-month sentence for conspiracy, smuggling, distributing misbranded drugs, and defrauding the United States. Court Enters Preliminary Injunction in Case Involving Silver Products Touted as a COVID-19 Treatment, United States v. Xephyr LLC, et al. Long did not have authorization to charge any of these victims accounts. The defendants had an extensive history of operating their food manufacturing facility under insanitary conditions, failing to follow current good manufacturing practice requirements and misbranding their food products. Docket Number: 2:18-CR-349 (E.D.N.Y). 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 May 8, 2019, the court sentenced Matthew Dailey to 24 months in prison for the illegal importation and sale of kratom, which he sold to consumers as a purported treatment for various serious diseases and medical conditions, including opiate withdrawal symptoms. The district court entered the proposed consent decree. Docket Number: 3:15-cr-496 (N.D. 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. Docket Number: 3:17-CR-547 (N.D. On January 16, 2020, the court granted the governments 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. In pleading guilty, the defendants admitted that they caused at least 225 vehicles to be sold with rolled back odometers. As part of Juxtapids 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. Docket Number: 1:17-CV-0236 (S.D. The general rule at common law was that in order for a government official to be protected by absolute immunity for common law torts, not only did the official have to be acting within the outer perimeter of his/her official duties, but the conduct at issue also had to be discretionary in nature. Victims never received any lottery winnings. The complaint alleges that Dr. Tobias Bacaner, Theodore Ferguson II, and Timothy Ferguson used Paragon Community Healthcare Inc., to unlawfully issue controlled substance prescriptions, and Cobalt Pharmacy Inc., to unlawfully fill controlled substance prescriptions, all in violation of the Controlled Substances Act. PharMedium also must take remedial measures to ensure compliance with the FDCA at its other facilities and at its headquarters in Illinois. On March 16, 2021, U.S. District Judge Randolph Moss denied plaintiff MediNatura Inc.s motion seeking a temporary injunction pending appeal of the courts decision on a previous motion for preliminary injunctive relief. Official websites use .gov United States v. Home Style Foods et al. The governments complaint alleges that the pharmacies and pharmacists violated the Controlled Substances Act ("CSA") by filling numerous prescriptions for controlled substances outside the usual course of professional practice and in violation of the pharmacists corresponding responsibility to ensure that prescriptions were written for a legitimate medical purpose. 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. Calif.). The governments complaint alleged that PharMediums drugs were adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health and because PharMedium failed to comply with current good manufacturing practices. Dietary Supplement Manufacturer Enjoined from Distributing Adulterated, Misbranded Products Marketed as DrugsUnited States v. EonNutra LLC et al.Press Release Docket Number: 0:19-cv-60570 (S.D. Docket NO. Docket Number: 2:19-cv-00324 (W.D. Several FDA inspections since 2011 revealed violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations and current Good Manufacturing Practice regulations. Four Defendants Charged in Indictment Unsealed in Clinical Trial Fraud Case. 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). When contacted by prospective victims, the conspirators used false and fraudulent promises and documents regarding the puppies, shipping fees, and coronavirus exposure to extract payments. TRO Shutters Website in First Enforcement Action Against COVID-19 Fraud, United States v. Doe In addition, S.K. No sentencing date has been set. The named defendants include direct mailers, printers, a cager, and a data manager who created and maintained lead lists. Docket NO. Laboratories is set for Aug. 12, 2019. The department filed a complaint in the U.S. District Court for the Central District of California on Nov. 21 alleging that Neptunes seafood products are produced under conditions that are inadequate to ensure the safety of its products. Tex.). The complaint alleges that the defendants ignored obvious signs of abuse or diversion when issuing and filling opioid prescriptions, and that drug toxicity played a role in the deaths of several individuals who received controlled substances from the defendants. The complaint alleged that FDA inspections of Keystones facilities and products revealed numerous problems, including an instance in which the company released a batch of hair products despite test results suggesting contamination by the potentially harmful bacteria Staphylococcus aureus. Docket Number: 2:20-cr-00196 (D. Nev.). On February 5, 2021, Maytee Lledo pleaded guilty to conspiracy to commit wire fraud in connection with an scheme to falsify clinical trial data. MediNatura challenges FDAs withdrawal of an enforcement-discretion policy for homeopathic drugs and the agencys addition of MediNaturas products to an import alert. Ltd., Aurora Jouffroy-Brandtner, Chantal Seguy, Marion Elchlepp, Macromark, Inc., Mary Ellen Meyer, Mail Order Solutions India Pvt. In the lawsuit, the United States alleged that the defendants violated the FTCs Telemarketing Sales Rule (TSR) by (1) making deceptive claims to, among other things, induce consumers to purchase the defendants DVDs, (2) placing numerous calls to phone numbers on the National Do Not Call (DNC) Registry, (3) ignoring consumers prior do-not-call requests, (4) failing to make required oral disclosures, (5) failing to transmit accurate caller ID information, and (6) abandoning calls answered by consumers. Filing Electronically How to File a Case Docket Number: 3:19-CV-1055 (N.D. 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. On June 5, 2017, the U.S. District Court for the Central District of Illinois ordered Dish Network, LLC to pay $280 million in civil penalties and damages to the United States and the states of California, Illinois, North Carolina, and Ohio in connection with more than 100 million illegal telemarketing calls. 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. and 3:15-CV-0371 (W.D.Wis.). Docket Number: 1:20-cr-20190 (S.D. Air was pushed into the clean room through the HEPA filters. 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. The Court found that given the egregiousness, seriousness, and willfulness of defendants past violations, coupled with their dubious promises of reform, a permanent injunction is necessary to prevent a substantial likelihood that defendants will violate the Act in the future. In a complaint filed in March 2019, the government alleged that the defendant uses telemarketers who, posing as computer technicians, contact unsuspecting consumers and falsely inform them that their computers have serious problems; the telemarketers then falsely tell consumers that the problems are resolved and then demand payment on one or more occasions for purported technical-support services. United States v. Bencosme, et al. )(related to United States v. Indivior Inc. et al., Docket Number: 19-CR-16 (W.D. Top Regulatory Official at Medical Device Company Sentenced 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 Food, Drug, and Cosmetic Act. Subject to Rules 23(e), 23.1(c), 23.2, and 66 and any applicable federal statute, the plaintiff may dismiss an action without a court order by filing: (i) a notice of dismissal before the opposing party serves either an answer or a motion for summary judgment; or 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 case is before U.S. District Judge Robert N. Scola. 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.

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