The owners and senior officers of a Massachusetts pharmacy that distributed contaminated drugs that killed 64 people have been arrested and two were charged with second degree murder.
Barry Cadden, owner and head pharmacist at the New England Compounding Center (NECC), and other top staffers not only knew their products weren’t sterile, but they conspired to cover it up, the U.S. Justice Department says in the indictment.
They also instructed staff to make up fake names and prescriptions to make it look as if the operation was a small-time compounding pharmacy, making up drugs to individual order, rather than the large-scale manufacturing operation that it actually was.
The products sent all over the country by NECC made more than 700 people very ill in 2012 and killed 64 of them from a hard-to-treat fungal infection of the spinal cord. They’d been sold as especially safe and carefully formulated steroid injections for pain. What they actually were, federal officials say, were carelessly prepared and unsanitary bottles filled with mold and bacteria.
In total, 14 people were charged in the indictment. Cadden and supervisory pharmacist Glenn Chin were charged with murder. Twelve others were charged with racketeering, mail fraud, conspiracy and other crimes.
“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,” U.S. Attorney General Eric Holder said in a statement.
The 131-count indictment names 14 employees or directors of NECC, including owners, officers, pharmacists and pharmacy technicians. Eleven of them have been arrested, Justice officials said during a news conference.
“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."
The 2012 outbreak shocked Americans and set off investigations by Congress and the Food and Drug Administration. The FDA’s since overhauled how it manages so-called compounding pharmacies – which the law and regulations had treated as mom-and-pop operations, but which often act more like large-scale pharmaceutical manufacturers.
Investigations quickly showed that NECC’s facility was filthy and that pharmacists working there were bypassing hygiene rules. Wednesday’s indictment shows that notes were posted across work spaces, instructing staff to take shortcuts in sterilizing and checking the safety of products and giving clear guidance on how to concoct fake prescriptions.
For instance, the indictment charges that supervisory pharmacist Glenn Chin told technicians that production was more important than cleaning or disinfecting.
“Chin instructed pharmacists and pharmacy technicians working in Clean room 1 under his supervision to fraudulently complete cleaning logs at the end of the month purporting to show that NECC Clean Room 1 was properly cleaned and disinfected," it reads.
Cadden and Chin face a maximum of up to life in prison if convicted.
Testing and alert systems showed mold and germs were growing and spreading, but NECC did not change any of its practices. Even when outside tests showed the company had shipped contaminated drugs to hospitals and pain clinics, NECC did nothing, the indictment alleges. “The physicians and patients were not notified of the potential risk of using the untested drugs,” it reads.
Sharon Carter, a pharmacy technician who was made director of operations, even wrote out rules for making it look as if NECC was making individual, made-to-order prescriptions instead of manufacturing large batches of product, the indictment says.
“A facility can’t continuously provide the same roster if names … unless they are truly treating the exact same patients over and over again! All names must resemble ‘real’ names … no obviously false names (Mickey Mouse),” it quotes one written memo as saying
Nonetheless, names such as “Big Baby Jesus” and “Method Man” – supposedly individuals whose doctors had written made-to-order prescriptions for -- appeared on shipped lots of products.
The 2012 outbreak at first mystified doctors. Fungal meningitis is rare and it wasn’t until an alert Tennessee epidemiologist noticed a pattern of unusually severe disease that federal health officials were brought in.
It turned out that NECC, which filed for bankruptcy in 2012, had shipped its fouled products to 14,000 people in 20 states.
“These stories of pain and suffering …are the reason we have been working so tirelessly in the pursuit of justice."
Victims of the contaminated products have told about months of agony and treatment that included surgery, strong drugs and weeks in bed. Some are still not better. Some have shared in a $100 million civil settlement.
Carmen Ortiz, U.S. Attorney for the District of Massachusetts, said her team had met with many of the victims and family members. “These stories of pain and suffering …are the reason we have been working so tirelessly in the pursuit of justice,” she told a news conference.
NECC officials also scrambled to protect their wealth once they knew they were in trouble, the Justice Department says.
“Finally, the indictment charges Carla Conigliaro, the majority shareholder of NECC, and her husband Douglas Conigliaro with transferring assets following the fungal meningitis outbreak,” the Justice Department said.
“Specifically, the indictment charges that after NECC declared bankruptcy, and the bankruptcy court ordered the shareholders not to transfer assets, Carla and Doug Conigliaro transferred approximately $33.3 million to eight different bank accounts opened after the NECC bankruptcy. “