Key players in what is considered to be the largest medical contamination case in U.S. history were indicted Wednesday by the Department of Justice (DOJ).
The DOJ announced a sweeping 131-count criminal indictment against the owners, cleaners and employees of the Framingham-based New England Compounding Center (NECC) for a fungal meningitis outbreak that killed more than 60 and infected hundreds across the country.
The indictment alleges NECC management knew they were producing tainted products in 2012, including a steroid used for back pain. According to the complaint, 751 patients in 20 states were diagnosed with a fungal infection after receiving an injection of the steroid commonly known as MPA created and distributed by NECC. Of that number, 64 people in nine states died from the infection.
“Getting a shot for back pain, eating a peanut butter sandwich, these are everyday activities, not Russian roulette,” said Joyce Branda, acting assistant attorney general for the Justice Department’s civil division, during a press conference Wednesday morning. “For these reasons those who produce the drugs we take and the food we eat have a special responsibility.”
Barry J. Cadden, 48, NECC’s owner and company pharmacist and Glenn A. Chin, 46, a supervisory pharmacist for the company, have been charged with 25 acts of second degree murder for deaths in numerous states, including Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia.
That duo, according to the indictment, acted “with an extreme indifference to human life.” They knew, according to federal authorities, they were making MPA in an unsafe manner in conditions that were unsanitary. Both men face up to life in prison.
The company failed to properly test the drugs for sterility, according to the indictment, and failed to correct their drug production even after its own environmental monitoring repeatedly detected mold and bacteria within its so-called “clean rooms” in 2012.
Federal prosecutors allege NECC then tried to shield what was going on from federal regulators by claiming to be a pharmacy that dispenses drugs pursuant to valid, patient specific prescriptions, when in fact NECC routinely dispensed drugs in bulk without valid prescriptions. NECC, according to the 73-page indictment, used fictional and celebrity names for false prescriptions in order to distribute drugs.
In addition to Cadden and Chin, twelve other individuals, all associated with NECC, including six other pharmacists, the director of operations, the national sales director, an unlicensed pharmacy technician, two other owners and another individual were charged with an array of crimes including racketeering, mail fraud, conspiracy, contempt, structuring and violations of the Food, Drug and Cosmetic Act.
Carla Conigliaro, the 51-year-old majority shareholder of NECC from Dedham, along with her husband, 53-year-old Douglas Conigliaro, were charged with transferring assets following the meningitis outbreak. The indictment alleges the couple transferred about $33.3 million to eight different bank accounts that were opened after a bankruptcy court ordered shareholders not to transfer assets.
Twelve of the fourteen who were indicted live in Massachusetts, two live in Rhode Island.