Latest news with #MagellanDiagnostics
Yahoo
11-03-2025
- Health
- Yahoo
‘Deceitful': 3 former execs at Mass.-based Magellan Diagnostics plead guilty over faulty lead tests
The former CEO and two other high-ranking executives for Massachusetts-based Magellan Diagnostics have pleaded guilty to criminal charges related to the company's lead-testing devices that produced inaccurately low results for tens of thousands of patients, the U.S. Attorney said Tuesday. Amy Winslow, 53, of Needham Heights, Magellan's former CEO, pleaded guilty to one felony count of introduction of misbranded medical devices into interstate commerce, U.S. Attorney Leah Foley said in a statement. U.S. District Court Judge Patti Saris scheduled her sentencing for July 23. Hossein Maleknia, 66, of Bonita Springs, Florida, Magellan's former chief operating officer, pleaded guilty to two felony counts of introduction of misbranded medical devices into interstate commerce. Saris scheduled his sentencing is scheduled for June 26. Reba Daoust, 68, of Amesbury, Magellan's former Director of Quality Assurance and Regulatory Affairs, pleaded guilty to one felony count of making false statements. She is scheduled to be sentenced on June 24. Winslow, Maleknia and Daoust were indicted by a federal grand jury in April 2023. Prosecutors said the three former executives misled regulators and customers about lead-testing devices manufactured by Magellan, a medical device company headquartered in Billerica. The company's LeadCare II and LeadCare Ultra devices detected lead levels and lead poisoning in the blood of children and adults using either venous, i.e., blood draws through the arm, or fingerstick samples. LeadCare II, which was predominantly used to test fingerstick samples, accounted for more than half of all blood lead tests conducted in the United States from 2013 through 2017. LeadCare Ultra was predominantly used to test venous samples. By hiding the malfunction and later misleading customers and the FDA about when they discovered the malfunction, and the risks associated with the malfunction, Winslow, Maleknia and Daoust 'caused an estimated thousands of children and other patients to receive inaccurately low lead test results,' Foley said. 'We trust that medical devices provide accurate results. We trust that when doctors give us information, it's based on reliable science. These defendants eroded that trust by misleading regulators and customers about devices they knew could provide inaccurate results, and thereby knowingly endangered the health of children and other patients across the country,' Foley said. 'These convictions should make one thing clear: corporate fraud that puts public health at risk will not go unpunished. Individuals who choose to mislead rather than uphold the integrity of our healthcare system will be held accountable,' Foley said. The FDA ultimately found that the LeadCare devices could not accurately test venous samples, leading to a recall of all LeadCare devices using venous samples and a warning to the public not to use the devices for venous blood samples because of the malfunction, Foley said. 'What these three senior executives did was downright deceitful and dangerous,' Jodi Cohen, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division, said in a statement. 'They concealed a medical device malfunction that resulted in inaccurate lead test results for thousands of children and other vulnerable patients in order to boost Magellan's bottom line. The public should know the FBI and our partners are working hard every day to ensure those who put profits over patient safety won't get away with it.' According to court documents, as referenced by the Centers for Disease Control and Prevention, there is no safe level of lead in the blood. Lead exposure may cause irreversible lifelong physical and mental health problems. Young children and pregnant women are most vulnerable to lead exposure, especially those from low-income households and those who live in housing built before 1978 because those homes are more likely to contain lead-based paint and have fixtures containing lead. 'These corporate executives knew about a serious flaw in Magellan's lead testing devices that produced inaccurate reporting of lead levels in the blood. They chose to conceal that flaw, completely disregarding the well-being of patients, in their corrupt effort to benefit the corporate bottom line,' Special Agent in Charge Roberto Coviello of the U.S. Department of Health and Human Services Office of Inspector General, said in a statement. 'These convictions serve as a strong reminder that we will continue to work tirelessly to investigate and bring to justice those who engage in dangerous schemes that put patient safety at risk.' If you or a family member believe you received an inaccurate blood lead test result from a LeadCare device between 2013-2017, federal officials are asking you to complete the questionnaire located on the FBI's website. Information about the status of the case is located on the U.S. Attorney's Office website. For the charges of introduction of misbranded medical devices, Winslow and Maleknia face a sentence of up to three years in prison, up to one year of supervised release and a fine of up to $250,000. For the charge of making false statements, Daoust faces a sentence of up to five years in prison, up to three years of supervised release and a fine of up $250,000 or twice the gross gain from the offense, whichever is greater. This is a developing story. Check back for updates as more information becomes available. Download the FREE Boston 25 News app for breaking news alerts. Follow Boston 25 News on Facebook and Twitter. | Watch Boston 25 News NOW
Reuters
10-03-2025
- Business
- Reuters
Former Magellan Diagnostics CEO pleads guilty over lead-test device defect
March 10 (Reuters) - The former CEO of Magellan Diagnostics pleaded guilty on Monday to a criminal charge related to a malfunction in the company's lead-testing devices that produced inaccurately low results for tens of thousands of patients. Amy Winslow was the last of three former Magellan executives indicted in 2023 over the malfunction to strike a deal to plead guilty rather than proceed to trial next month in federal court in Boston. She agreed to plead guilty, opens new tab to a single count in the indictment that charged her with violating the Food, Drug and Cosmetic Act by introducing misbranded medical devices into interstate commerce with the intent to mislead. That charge related to allegations that after Magellan discovered the malfunction, it sent customers a letter in 2014 that Winslow edited to advise them to incubate blood samples for 24 hours before using one of its lead-testing devices. Prosecutors said those instructions were contrary to the device's label, which promised immediate, accurate results without any incubation, and were altered without first notifying the U.S. Food and Drug Administration as required. Prosecutors have agreed to recommend that Winslow be sentenced to a year and a day in prison and a $10,000 fine and to drop various fraud charges against her. Her sentencing was set for July 23. Winslow's lawyer did not respond to requests for comment. Massachusetts-based Magellan, now owned by Ohio-based Meridian Bioscience, in May agreed to pay $42 million and plead guilty to resolve related charges concerning the reliability of devices it sold for detecting lead levels and lead poisoning in the blood of children and adults. The malfunction was discovered in 2013 and affected three testing devices in Magellan's LeadCare line, including one that accounted for more than half of all blood lead tests conducted in the U.S. between 2013 and 2017, according to prosecutors. Prosecutors said Winslow and her co-defendants never reported the issue to the FDA and only notified the agency after Meridian had acquired the company for $66 million in 2016. A recall was launched in 2017. Prosecutors have also recently reached plea deals with Hossein Maleknia, Magellan's former chief operating officer, and Reba Daoust, the company's former manager and director of quality assurance and regulatory affairs.
Boston Globe
04-03-2025
- Business
- Boston Globe
Former US Attorney Joshua Levy heads back to Boston law firm Ropes & Gray
Levy had left Ropes to serve as First Assistant US Attorney in January 2022. He had applied for the top job, but Rachael Rollins was picked instead. However, Levy ended up leading the office and its roughly 125 prosecutors in May of 2023 as acting US Attorney after Rollins resigned amid two ethics probes. President Joe Biden later nominated Levy for the permanent post in October of that year, but that nomination was held up in the Senate; then-Attorney General Merrick Garland eventually appointed Levy to the role of US Attorney last November, with two months left of the Biden administration. Levy had previously worked as a federal prosecutor in the Boston office from 1997 through 2004, and then worked at Ropes for 17 years, eventually co-chairing the firm's litigation practice. He'll return as a partner in that same practice. Advertisement 'It was a very intense several years for me,' Levy said of his most recent tenure in the US Attorney's office. 'What the office went through with the resignation of the former US Attorney, I developed some skills in the moment that I wasn't sure I had, to help the office rebound very quickly. ... I worked seven days a week for three years and would have kept doing it for longer.' Among the cases he's most proud of prosecuting during his three years as the office's leader or second-in-command: one involving Magellan Diagnostics, a Massachusetts company that improperly marketed the effectiveness of its lead-testing devices for children; consulting giant McKinsey & Co.'s $650 million settlements for its work advising opioid maker Purdue Pharma to 'turbocharge' sales of Oxycontin; and the successful insider trading pursuit of a Russian millionaire who hacked US computers to obtain earnings information and rack up tens of millions in illegal profits after trading with that secret information. (The businessman, Vladislav Klyushin, was later traded to Russia in the prisoner exchange that brought home Wall Street Journal reporter Evan Gershkovich.) Advertisement While Levy was in the office, he implemented new trial preparation procedures for prosecutors. Levy said that contributed to the US Attorney's office not losing one criminal trial in 2024 (though two of the 34 trials did end in hung juries). 'I'm not the one doing the work,' Levy said. 'The phenomenal people ... are doing the work in my office. It's such a high-quality office. I sometimes say I wish the public could see what's going on in a prosecutor's office like ours — the amount of time to get it right and the lack of discussion about politics at any stage.' Speaking of politics, what about the concerns that President Trump would deploy Department of Justice prosecutors for political ends? Levy said he has complete confidence in his successor, Foley, who had previously been deputy chief of the office's narcotics and money laundering unit. 'She's a true pro,' Levy said. 'I have full confidence in her ability ... to follow the facts of the law without consideration of external factors.' As he returns to private practice, Levy said he is looking forward to helping individuals and companies navigate the challenges they face when confronted with adverse government enforcement. Levy said he didn't think about going anywhere other than back to his old law firm, which also happens to be the biggest in Boston. Advertisement Ropes chair Julie Jones said in a statement that she's thrilled to have Levy back on her team, 'especially as the enforcement landscape gets more complex for our clients.' Jones described Levy as a 'powerhouse on both sides of the enforcement table, recently spearheading some of the government's most notable prosecutions and investigations.' And Jeff Katz, co-managing partner of the firm's Boston office, praised Levy's legal experience and knowledge. 'Through Josh's previous tenure at the firm, we've seen firsthand just how impactful his presence, insights and expertise are — for our clients, our attorneys, and the entire Ropes community,' Katz said in an email. Levy hasn't ruled out taking another government gig some day. In fact, he's hoping for it — if the timing and situation is right, either in Washington or Massachusetts. 'I did a lot of pro bono work before and I expect to do that again,' Levy said. 'I'm still trying to figure out a way to be active in public service. I'm just not sure what that is right now.' This is an installment of our weekly Bold Types column about the movers and shakers on Boston's business scene. Jon Chesto can be reached at
