Category: MIL-OSI

Source: United States Department of Justice Criminal Division

A Mississippi seafood distributor and two company managers pleaded guilty today to conspiring with others to mislabel seafood and to commit wire fraud by marketing inexpensive and frozen imported substitutes as more expensive and premium local species. 

Quality Poultry and Seafood Inc. (QPS), the largest seafood wholesaler on the Mississippi Gulf Coast, has agreed to pay the United States $1 million in forfeitures and a criminal fine of $150,000. QPS sales manager Todd A. Rosetti and business manager James W. Gunkel, both of Ocean Springs, Mississippi, also pleaded guilty to misbranding seafood to facilitate QPS’ fraud. 

QPS admitted to participating in this fish substitution scheme from as early as 2002 and continuing through November 2019. The indictment alleges that QPS recommended and sold to its restaurant customers foreign-sourced fish that could serve as convincing substitutes for the local species the restaurants advertised on their menus. QPS also labeled the cheap imports that it sold to customers at its own retail shop and café as premium local fish.

“QPS and company officials went to great lengths in conspiring with others to perpetuate fraud for more than a decade, even after they knew they were under federal investigation,” said Assistant Attorney General Todd Kim of the Justice Department’s Environment and Natural Resources Division. “Mislabeling seafood harms local wholesalers and fishermen who compete to sell locally sourced, premium fish in a market unfairly flooded with less expensive fish, frozen and imported from overseas.”

“When imported substitutes are marketed as local domestic seafood, it depresses the value of authentic Gulf Coast seafood, which means that honest local fishermen and wholesalers have a harder time making a profit,” said U.S. Attorney Todd W. Gee for the Southern District of Mississippi. “This kind of mislabeling fraud hurts the overall local seafood market and rips off restaurant customers who were paying extra to eat a premium local product. These convictions should serve as a warning: restaurants and wholesalers will face criminal prosecution if they are not honest with customers about what they are actually buying.”

“U.S. consumers expect their seafood to be correctly identified. When sellers purposefully substitute one fish species for another, they deceive consumers and cause potential food safety hazards to be overlooked or misidentified by processors or end users,” said Special Agent in Charge Justin Fielder of the Food and Drug Administration (FDA)’s Office of Criminal Investigations, Miami Field Office. “We will continue to investigate and bring to justice those who put profits above public health.”

The indictment alleges that even after agents from the FDA executed a criminal search warrant at QPS to investigate its sale of mislabeled fish, QPS continued for over a year to sell frozen fish imported from Africa, South America and India for use as substitutes for local premium species.

Mary Mahoney’s, which pleaded guilty in May, admitted that between December 2013 and November 2019, it fraudulently sold, as local premium species, approximately 58,750 pounds (over 29 tons) of fish that was not the species identified on its menu. QPS supplied seafood to Mary Mahoney’s and many other restaurant restaurants and retailers.

QPS, Rosetti and Gunkel will be sentenced on Dec. 11. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

FDA’s Office of Criminal Investigations is investigating the case.

Senior Trial Attorney Jeremy F. Korzenik of the Environment and Natural Resources Division’s Environmental Crimes Section and Assistant U.S. Attorney Andrea Jones for the Southern District of Mississippi are prosecuting the case.

Source: United States Department of Justice Criminal Division

A California man was sentenced today to 37 months in prison for his role in a $2.8 million fraud scheme in which Medicare was billed for hospice services that the patients did not need.

According to court documents and evidence presented at trial, John Thropay, M.D., 75, of Arcadia, was the medical director of multiple hospice companies, including Blue Sky Hospice Inc., located in Van Nuys, California. From October 2014 to March 2016, Thropay fraudulently certified Medicare patients of Blue Sky Hospice as having terminal illnesses that the patients did not have so that the company could bill Medicare for hospice services. In 2015, Thropay was listed as attending provider for more hospice claims paid by Medicare than any other provider in the nation.

Thropay was convicted at trial in the Central District of California of one count of conspiracy to commit health care fraud and four counts of health care fraud on Feb. 15.

Principal Deputy Assistant Attorney General Nicole M. Argentieri, head of the Justice Department’s Criminal Division, U.S. Attorney E. Martin Estrada for the Central District of California, Acting Assistant Director in Charge Akil Davis of the FBI Los Angeles Field Office and Special Agent in Charge Timothy DeFrancesca of the Department of Health and Human Services, Office of Inspector General (HHS-OIG)’s Los Angeles Regional Office made the announcement.

The FBI and HHS-OIG investigated the case.

Assistant Deputy Chief Niall M. O’Donnell and Trial Attorney Eric C. Schmale of the Criminal Division’s Fraud Section prosecuted the case.

The Fraud Section leads the Criminal Division’s efforts to combat health care fraud through the Health Care Fraud Strike Force Program. Since March 2007, this program, currently comprised of nine strike forces operating in 27 federal districts, has charged more than 5,400 defendants who collectively have billed federal health care programs and private insurers more than $27 billion. In addition, the Centers for Medicare & Medicaid Services, working in conjunction with HHS-OIG, are taking steps to hold providers accountable for their involvement in health care fraud schemes. More information can be found at www.justice.gov/criminal-fraud/health-care-fraud-unit. 

Source: United States Department of Justice Criminal Division

The founder and chief executive officer of a California-based company that marketed stem cell-based products linked to multiple hospitalizations pleaded guilty today to a felony violation of the Federal Food, Drug and Cosmetic Act.

John W. Kosolcharoen, 53, most recently of Orange County, California, pleaded guilty to introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead. Kosolcharoen is currently in custody serving a sentence for a separate, unconnected conviction. U.S. District Judge Otis D. Wright II for the Central District of California presided over the hearing pursuant to a plea agreement with the government. The court set Kosolcharoen’s sentencing for Sept. 23.

According to court documents, beginning in 2016, Kosolcharoen created two companies, Liveyon LLC and Genetech Inc., to manufacture and distribute injectable stem cell products made from human umbilical cord blood. Liveyon marketed the products under different brand names, including “ReGen.” In pleading guilty, Kosolcharoen admitted that he and others misrepresented ReGen as suitable for the treatment of a variety of conditions, such as lung and heart diseases, autoimmune disorders, Alzheimer’s disease, Parkinson’s disease and others. Liveyon marketed the products throughout the United States until about April 2019 using advertising materials that contained multiple false and misleading statements about their purported safety and effectiveness.

In recent years, the U.S. Food and Drug Administration (FDA) has warned consumers that patients seeking cures and remedies for serious diseases and conditions may be misled about unapproved stem cell products that are illegally marketed, have not been shown to be safe or effective, and, in some cases, may have significant safety issues that put patients at risk. Stem cell products are regulated by FDA, and generally they must have FDA approval before being introduced into interstate commerce.

As part of the plea agreement, Kosolcharoen admitted that to mislead FDA about Liveyon’s activities, he directed Liveyon’s purchase orders to falsely state that the stem cell products were being sold “for research purposes only.” In 2018, FDA and the Centers for Disease Control and Prevention (CDC) received reports of patients in multiple states requiring hospitalization for bacterial infections after receiving Liveyon products. Kosolcharoen admitted that he and others fraudulently induced customers into purchasing stem cell-derived Liveyon products by, among other things, misleading the public about the cause and severity of adverse events suffered by Liveyon patients, and falsely reporting and concealing material facts regarding the outcome of an FDA inspection of Genetech. According to FDA records, that inspection documented evidence of significant deviations from good manufacturing and tissue practices.

“Unapproved stem cell treatments not only endanger public health but also exploit the hopes of patients who seek relief from the most serious of diseases,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “The Department of Justice is committed to safeguarding the public from these schemes and will vigorously pursue legal action to hold accountable those who unlawfully market and sell these unproven therapies.”

“This defendant recklessly put people’s lives in danger, giving false hope to patients with serious illnesses,” said U.S. Attorney Martin Estrada for the Central District of California. “Today’s guilty plea shows that we will hold accountable corporate executives and healthcare professionals who put profits over patients.”

“We are grateful for the work by the Department of Justice to hold accountable establishments that prey upon vulnerable populations by marketing potentially dangerous stem cell products with false and misleading claims about their safety and effectiveness,” said Director Peter Marks, M.D., Ph.D. of FDA’s Center for Biologics Evaluation and Research.

“When unscrupulous providers offer umbilical cord blood stem cell products and treatments that are both unapproved and unproven, they put consumers’ health at risk, and multiple users of this firm’s products in fact suffered adverse events,” said Special Agent in Charge Robert Iwanicki of FDA Office of Criminal Investigations Los Angeles Field Office. “FDA will continue to investigate and bring to justice those who endanger the public’s health for material gain.”

“This investigation was a joint effort between multiple federal agencies and state and local health departments to quickly put a stop to the distribution of unsafe, contaminated products,” said Director Michael Bell, M.D. of CDC’s Division of Healthcare Quality Promotion. “The rapid response by our public health system identified products marketed as stem cell treatments to be the source of serious infections in dozens of patients. Our message to all consumers and providers is to heed the warning against the use of unapproved products like these with unproven claims of effectiveness for conditions like joint disease, chronic pain, or COVID-19. Please don’t let products like these put you or your patients’ health at risk.”

FDA’s Office of Criminal Investigations, FBI, Amtrak Office of Inspector General, Defense Criminal Investigative Service, Department of Health and Human Services Office of Inspector General, Department of Labor Employment Benefits Security Administration and California Department of Health Care Services investigated the case.

Assistant U.S. Attorneys Mark Aveis and David Chao for the Central District of California, Assistant Director Ross S. Goldstein and Trial Attorneys Meredith B. Healy, Kathryn A. Schmidt and Peter J. Leininger of the Justice Department’s Consumer Protection Branch are prosecuting the case.

Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.

Source: United States Department of Justice Criminal Division

The Justice Department announced today that it has reasonable cause to believe that the Commonwealth of Kentucky (Kentucky) is violating the Americans with Disabilities Act (ADA) in the Louisville/Jefferson County Metro area by unnecessarily segregating adults with serious mental illness in psychiatric hospitals, rather than providing care in integrated community settings.

“People with serious mental illnesses in Louisville are caught in an unacceptable cycle of repeated psychiatric hospitalizations because they cannot access community-based care,” said Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division. “We thank Kentucky for its full cooperation with our investigation, including readily providing access to staff, documents, and data. We also recognize that Kentucky has already begun taking important steps to expand access to a range of key services, including crisis response services; medication management supports; and housing and employment supports. Our goal is to work collaboratively with Kentucky so that it implements the right community-based mental health services and complies with the ADA. The Justice Department will continue to safeguard the rights of people with disabilities to ensure that they can fully participate in and contribute to their communities.”

“These findings demonstrate that the Commonwealth of Kentucky fails to provide adequate community-based mental health services for individuals with serious mental illness in the Louisville Metro area,” said U.S. Attorney Michael A. Bennett for the Western District of Kentucky. “Beyond the violations, however, these findings are also about recognizing the dignity and potential of every individual who has mental illness.”

The department’s investigation found Kentucky fails to provide access to community-based mental health services for many people with serious mental illness who need them, including services such as: mobile crisis response, crisis stabilization and crisis respite, case management, Assertive Community Treatment, Permanent Supportive Housing, supported employment and peer support. Instead, Kentucky relies unnecessarily on psychiatric hospitals in violation of the ADA. Each year, thousands of people are admitted to psychiatric hospitals in Louisville, and more than a thousand people experience multiple admissions to these restrictive and often traumatizing settings. With the right community-based services, many of these hospitalizations could be prevented. Kentucky can remedy this violation by expanding community-based services and implementing processes to ensure that individuals can receive those services.

The lack of community-based services has also left law enforcement as routine responders to mental health crises, contributing to avoidable law enforcement encounters and incarceration.

Deficiencies in Louisville Metro Government’s emergency response system also contribute to these outcomes. In a separate investigation, the Justice Department concluded, in March 2023, that the Louisville Metro Government and Louisville Metro Police Department violated the ADA by subjecting people with behavioral health disabilities to an unnecessary police response. The department and Louisville are currently negotiating a consent decree to resolve these and other issues.

Individuals with information relevant to this matter can contact the department by emailing Community.Kentucky@usdoj.gov.

Additional information about the Civil Rights Division of the Justice Department is available at www.justice.gov/crt/rights-persons-disabilities and www.ada.gov.

Additional information about the U.S. Attorney’s Office for the Western District of Kentucky’s Civil Rights Program is available at www.justice.gov/usao-wdky/civil-rights-program.