Barry J. Cadden is charged with second-degree murder under the RICO Act.
Five years after the nationwide fungal meningitis outbreak that killed 64 people, the owner and head pharmacist of the now-defunct New England Compounding Center (NECC) is facing racketeering, mail fraud, and murder charges in U.S. District Court in Boston.
Back in 2014, Barry J. Cadden was charged with second-degree murder under the Racketeer Influenced and Corrupt Organizations Act (RICO). The charges against him were prompted by the deaths of patients in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee, and Virginia.
Editor’s Choice: Quality assurance in a post-NECC world
Prosecutors allege that Cadden and other employees of the Framingham, Mass.-based NECC compounded medications in unsanitary conditions. In 2012, more than 750 patients in 20 states were sickened by contaminated vials of preservative-free methylprednisolone acetate.
Numerous NECC employees were accused of using expired ingredients, creating fictitious patients, failing to properly test drugs, and not disinfecting the sterile rooms where drugs were compounded.
Prosecutors also charged NECC’s supervisory pharmacist, Glenn Chinn, with second-degree murder. Robert Ronzio, the company’s sales director, pleaded guilty to conspiring to defraud the FDA. Carla Conigliaro, NECC’s majority owner, and her husband Douglas Conigliaro were convicted of financial improprieties. They both received probation and fines.
Open statements in Cadden’s trial were delivered this week. His lawyers contend that NECC, not Cadden, is to blame. Chin will be tried separately after Cadden.
In 2013, NECC’s owners and insurers established a $100 million compensation fund for victims. Hundreds of patients were diagnosed with fungal meningitis or other fungal infections from compounded steroids used for pain relief.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.