Tag: FDA

BOSTON – Magellan Diagnostics, Inc., a medical device company headquartered in Billerica, Mass., has agreed to resolve criminal charges relating to its concealment of a device malfunction that produced inaccurately low lead test results for potentially tens of thousands of children and other patients.  As part of the criminal resolution, Magellan will plead guilty to violations of the federal Food, Drug and Cosmetics Act and pay a $21.8 million fine, $10.9 million in forfeiture and a minimum of $9.3 million to compensate patient victims….

Department of Justice U.S. Attorney’s Office Office of Public Affairs FOR IMMEDIATE RELEASE Thursday, February 29, 2024  United States Also Reaches Settlement with Endo International in Bankruptcy Case Endo Health Solutions Inc. (EHSI), which is in bankruptcy, has agreed to resolve criminal and civil investigations related to the company’s sales and marketing of the opioid drug Opana ER with INTAC (Opana ER), the Justice Department announced today. The United States has also reached an agreement in Endo’s bankruptcy case to…

U.S. Attorney’s Office Eastern District of California  FOR IMMEDIATE RELEASE Thursday, November 16, 2023 FRESNO, Calif. — A federal grand jury returned a three-count indictment today against Jia Bei Zhu, aka Jesse Zhu, Qiang He, and David He, 62, a citizen of China who formerly resided in Clovis, charging him with distributing adulterated and misbranded medical devices in violation of the federal Food, Drug, and Cosmetic Act and for making false statements to the Food and Drug Administration (FDA), U.S….

U.S. Attorney’s Office Eastern District of Florida FOR IMMEDIATE RELEASE Thursday, October 12, 2023  BEAUMONT, Texas – A Houston man who served as a production manager in a counterfeit drug trafficking scheme has been sentenced to federal prison for drug trafficking and money laundering violations in the Eastern District of Texas, announced U.S. Attorney Damien M. Diggs today. Willis Reed, 61, pleaded guilty to conspiracy and was sentenced to 60 months in federal prison today by U.S. District Judge Marcia…

FOR IMMEDIATE RELEASE Thursday, September 7, 2023 A jury in Miami convicted two defendants on Sept. 5 in a scheme involving the falsification and fabrication of clinical trial data. On Sept. 5, Miguel Angel Montalvo Villa, 53, and Ivette Maria Portela Martinez, 53, both of Miami, were each convicted of one count of conspiracy to commit wire fraud and one count of wire fraud. Montalvo also was convicted of making a false statement to a regulatory investigator with the Food…

FDA OCI, Greater Boston Behavioral Health, guilty, plea, misbranded, drugs, prescription, Rx, $2.5 million, fines, forfeiture, Botox, foreign, black box, warning, side effects, migraine, treatment, consumer protection,

LOS ANGELES – A former doctor has been sentenced to 84 months in federal prison for scheming to defraud private insurance companies and the Tricare health care program for U.S. military service members by fraudulently submitting nearly $120 million in claims related to the 1-800-GET-THIN Lap-Band surgery business, the Justice Department announced today.

Julian Omidi, 54, of West Hollywood, was sentenced Monday evening by United States District Judge Dolly M. Gee.

Judge Gee also sentenced Surgery Center Management LLC (SCM), an Omidi-controlled Beverly Hills-based company, to five years’ probation. A separate hearing on restitution and forfeiture in this case, along with SCM’s fine, is expected in the coming weeks. 

U.S. Attorney Damian Williams said: “As alleged, at the direction of its founder and CEO Laura Perryman, Stimwave created a dummy medical device component — made entirely of plastic — designed to be implanted in patients for the sole purpose of causing doctors to unwittingly bill Medicare and private insurance companies more than $16,000 for each implantation of the piece of plastic.  The defendant and Stimwave did this so that they could charge medical providers many thousands of dollars for purchasing their medical device.  Our Office will continue to do everything in its power to bring to justice anyone responsible for perpetuating health care fraud, which in this case led to patients being used as nothing more than tools for financial enrichment.”

  U.S. Department of Justice FOR IMMEDIATE RELEASE Friday, February 3, 2023 Food and ingredient manufacturing company Kerry Inc. pleaded guilty today to a charge that it manufactured breakfast cereal under insanitary conditions at a facility in Gridley, Illinois, that was linked to a 2018 salmonellosis outbreak. Pursuant to a plea agreement filed with a criminal information in federal court in Peoria, Illinois, Kerry pleaded guilty to a misdemeanor count of distributing adulterated cereal marketed as Kellogg’s Honey Smacks. The…

Department of Justice U.S. Attorney’s Office Northern District of California FOR IMMEDIATE RELEASE Friday, January 27, 2023 After two-week trial, federal jury found Miller and his company both guilty of conspiracies involving racketeering, mail and wire fraud, and money laundering, in addition to substantive mail fraud and conspiracy against the United States. SAN FRANCISCO – A federal jury convicted David Jess Miller and his company, Minnesota Independent Cooperative (“MIC”), of a wide array of charges relating to the unlicensed and…

LOS ANGELES – A Tarzana man pleaded guilty today to federal criminal charges for running a nearly $6 million scheme in which he knowingly sold used skin-tightening medical devices that were deliberately misbranded as new, as well as counterfeit devices that he claimed were to be used with fat-reducing laser machines. Kambiz Youabian, 49, pleaded guilty to a two-count information charging him with mail fraud and introducing a misbranded medical device into interstate commerce. According to his plea agreement, Youabian…

  U.S. Department of Justice FOR IMMEDIATE RELEASE Wednesday, January 4, 2022 Pennsylvania-based medical device distributor Jet Medical Inc. (Jet) agreed to pay $200,000 to resolve criminal allegations relating to a migraine headache treatment, and Jet and two related companies agreed to pay another $545,000 in a civil settlement involving the same device. In a criminal information filed today in the Southern District of Illinois, the government alleged that between April 2014 and April 2019, Jet introduced into interstate commerce devices…

  U.S. Department of Justice FOR IMMEDIATE RELEASE Tuesday, December 20, 2022 A federal grand jury in the District of Maryland returned an indictment that was unsealed today charging two men for their roles in schemes to defraud investors in CytoDyn Inc., a publicly traded biotechnology company (OTCQB: CYDY) based in Vancouver, Washington. According to court documents, Nader Pourhassan, 59, of Lake Oswego, Oregon, and Kazem Kazempour, 69, of Potomac, Maryland, allegedly engaged in a conspiracy to defraud investors through…

FRANFORT, Ky. — A Florida company, Modern Therapy, LLC, was sentenced on Friday to pay a $2.5 million fine by U.S. District Judge Gregory VanTatenhove for the unlawful distribution of anabolic steroids. Modern Therapy operated out of Hallandale Beach, Florida.  According to its plea agreement, it marketed anabolic steroids, human growth hormone, and related products to customers over the Internet.  Anabolic steroids are a Schedule III controlled substance and may only be issued pursuant to a valid prescription for a…

BOSTON – A former co-owner of the now-defunct New England Compounding Center (NECC) was sentenced today in federal court in Boston in connection with conspiring to defraud the Food and Drug Administration (FDA). Gregory Conigliaro, 57, of Southborough, Mass. was sentenced by U.S. District Court Judge Richard G. Stearns to one year in prison and one year of supervised release. In December 2018, Conigliaro was convicted following a 41-day jury trial of one count of conspiracy to defraud the United…