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DOJ indicts 14 involved with 2012 fungal meningitis outbreak
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Fourteen people were indicted in connection with the 2012 fungal meningitis outbreak caused by contaminated vials of injectable steroids, according to the Department of Justice.
The 131-count criminal indictment included charges for 25 acts of second-degree murder brought against Barry J. Cadden, the owner and head pharmacist of the New England Compounding Center (NECC), and Glenn A. Chin, NECC’s supervisory pharmacist.
The other 12 individuals also were associated with NECC, including six pharmacists, the director of operations, the national sales director, an unlicensed pharmacy technician, two of NECC’s owners and another individual. The charges include racketeering, mail fraud, conspiracy, contempt, structuring and violations of the Food, Drug and Cosmetic Act.
“As alleged in the indictment, these employees knew they were producing their medication in an unsafe manner and in insanitary conditions, and authorized it to be shipped out anyway, with fatal results,” Attorney General Eric Holder said in the press release. “With the indictment and these arrests, the Department of Justice is taking decisive action to hold these individuals accountable for their alleged participation in grievous wrongdoing. Actions like the ones alleged in this case display not only a reckless disregard for health and safety regulations, but also an extreme and appalling indifference to human life.”
According to the CDC, the outbreak resulted in 751 cases of fungal meningitis across 20 states; 64 patients died. Vials of preservative-free methylprednisolone acetate that were manufactured at the NECC facility in Framingham, Mass., were primarily contaminated with Exserohilum rostratum. There also was one patient with an infection of Aspergillus fumigatus.
The 25 second-degree murder charges are included as predicate racketeering acts under the Racketeer Influenced and Corrupt Organizations (RICO) Act, and relate to patients who received the tainted steroids and died in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia. Second-degree murder charges do not require the government to prove that Cadden and Chin had specific intent to kill the patients, only that they acted with “extreme indifference to human life,” according to the DOJ release. The indictment alleges both men knew the NECC was making the drugs in an unsafe manner and environment, but still authorized the shipment of the contaminated drugs, fully aware the vials could be contaminated and could kill patients.
The indictment reveals a broad racketeering scheme and alleges that other NECC pharmacists knowingly made and sold many drugs in a similar unsafe manner, including 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 drugs to customers. The indictment also alleges insanitary conditions, including lack of proper cleaning and failure to take action when its own environmental monitoring repeatedly detected mold and bacteria throughout 2012.
“Ever since the outbreak occurred, we have been committed to bringing to justice the individuals responsible for the deaths and suffering of so many innocent victims,” US Attorney Carmen Ortiz, for the District of Massachusetts, said in the press release. “This indictment is the first step in that process which addresses alleged criminal wrongdoing at NECC, a business that prioritized production and profit over safety. We will make every effort to ensure that licensed pharmacists, and those working with them, are held to a standard of care that protects the public from unsafe and dangerous medications.”