Two owners and twelve former employees of a Massachusetts compounding pharmacy were arrested on Wednesday in connection with a meningitis outbreak two years ago. 751 people across 20 states had been diagnosed with a fungal infection, of which 64 had ultimately died. Tainted steroids made by the company under unsanitary conditions and using expired ingredients were blamed for the outbreak.
The New England Compounding Center (NECC) located in the city of Framingham, Massachusetts in the US north east, was owned by Barry Cadden and Gregory Conigliaro.
The US Centers for Disease Control and Prevention said the outbreak was caused by contaminated vials of preservative-free methylprednisolone acetate manufactured by NECC.
A detailed, 73-page grand jury indictment unsealed in Boston leveled 131 charges against the defendants, including racketeering, mail fraud, conspiracy and second degree murder. The most serious charges were leveled against Cadden and supervisory pharmacist Glenn Chin, who face up to life in prison if convicted on all counts.
The indictment alleges that the pharmacy used expired ingredients to make drugs, falsely labelled drugs, failed to properly sterilize drugs, failed to properly clean and disinfect working areas and shipped out untested medications over a four year period beginning 2008.
It accuses the pharmacy of delivering untested drugs and drugs made with expired ingredients across the country. It also alleges drugs were made by an unlicensed technician and names of celebrities were used to create fraudulent prescriptions, such for a Michael Jackson and a Diana Ross in Nebraska.
“The Department of Justice is taking decisive action to hold these individuals accountable for their alleged participation in grievous wrongdoing,” said Attorney General Eric Holder.
“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. American consumers have a right to know that their medications are safe to use,” he added.
The fungus contaminating the steroids was so prevalent that it could be seen with the naked eye in some vials. The NECC lost its license in 2012 after inspectors found it guilty of multiple sanitary violations. After that, the company recalled all its products and shut it down voluntarily. The outbreak of this infection had led to calls for tighter regulations of the loosely controlled pharmaceutical compounding industry in the U.S.