The U.S. Department of Justice announced a 131-count criminal indictment was unsealed today in Boston, Mass., in connection with the 2012 nationwide fungal meningitis outbreak. Barry J. Cadden, owner and head pharmacist of New England Compounding Center and NECC’s supervisory pharmacist Glenn A chin have been charged with 25 acts of second-degree murder in Indiana, Florida, Maryland, Michigan, North Carolina, Tennessee and Virginia.
The outbreak was caused by contaminated vials of preservative-free methylprednisolone acetate manufactured by NECC, located in Framingham, Mass. The U.S. Centers for Disease Control and Prevention reported that 751 patients in 20 states were diagnosed with a fungal infection after receiving injections of NECC’s MPA. Of those 751 patients, the CDC reported that 64 patients in nine states died.
The 25 second-degree murders are included in the indictment as predicate racketeering acts under the Racketeer Influenced and Corrupt Organizations Act. These charges relate to patients who received NECC MPA and died in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia. As a general matter, and depending on particular state law, second-degree murder does not require the government to prove Cadden and Chin had specific intent to kill the patients, but rather that Cadden and Chin acted with extreme indifference to human life.
According to the indictment, Cadden and Chin knew that NECC was making MPA in a manner and in an environment in which they could not assure that the drug was sterile. Despite knowing they were making the MPA in an unsafe manner and in insanitary conditions, Cadden and Chin allegedly directed and authorized the shipping of MPA to NECC customers nationwide. It is alleged Cadden and Chin were aware doctors would inject MPA into their patients’ bodies, and if the MPA was not in fact sterile, it could kill them.
The 25 murder racketeering acts comprise only a portion of the broad racketeering scheme charged in the indictment. The indictment also alleges that NECC’s other pharmacists knowingly made and sold numerous drugs in a similar unsafe manner and in insanitary conditions. The unsafe manner alleged includes: the pharmacists’ failure to properly sterilize NECC’s drugs, failure to properly test NECC’s drugs for sterility, and failure to wait for test results before sending the drugs to customers. The insanitary conditions alleged in the indictment include, among other things, NECC’s lack of proper cleaning and NECC’s failure to take any action when its own environmental monitoring repeatedly detected mold and bacteria within NECC’s clean room suite of rooms throughout 2012.
It is further alleged NECC repeatedly took steps to shield its operations from regulatory oversight by the FDA by claiming to be a pharmacy dispensing drugs pursuant to valid, patient-specific prescriptions. In fact, NECC routinely dispensed drugs in bulk without valid prescriptions. The indictment alleges NECC even used fictional and celebrity names on fake prescriptions to dispense drugs.
Twelve other individuals, all associated with NECC, including six other pharmacists, the director of operations, the national sales director, an unlicensed pharmacy technician, two of NECC’s owners, and one other individual were charged with additional crimes including racketeering, mail fraud, conspiracy, contempt, structuring, and violations of the Food, Drug and Cosmetic Act.
The details contained in the indictment are allegations. The defendants are presumed innocent unless and until proven guilty beyond a reasonable doubt.
Victims with questions about today’s charges may call (888) 221-6023 or e-mail [email protected]