Mold and bacteria were in the air and on workers' gloved fingertips. Pharmacists used expired ingredients, didn't properly sterilize them and failed to test drugs for purity before sending them to hospitals and pain clinics. Employees falsified logs to make it look as if the so-called clean rooms had been disinfected.
Federal prosecutors leveled those allegations in bringing charges Wednesday against 14 former owners or employees of a Massachusetts pharmacy in connection with a nationwide meningitis outbreak that killed 64 people.
U.S. Attorney Carmen Ortiz called it the biggest criminal case ever brought in the U.S. over contaminated medicine.
The 2012 outbreak was traced to tainted drug injections manufactured by the now-closed New England Compounding Center of Framingham.
Barry Cadden, a co-founder of the business, and Glenn Adam Chin, a supervisory pharmacist, were slapped with the most serious charges, accused in the racketeering indictment of causing the deaths of 25 patients in seven states by acting with "wanton and willful disregard" of the risks.
The other defendants were charged with such crimes as fraud and interstate sale of adulterated drugs.
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Jeffrey Grell, a former prosecutor in Minnesota who is an expert on RICO, said it is unusual to use the law to prosecute a pharmaceutical company.
But "here, you've got such a close link between the meningitis and the malfeasance at the laboratory, I can totally understand why the U.S. Attorney's Office is using it in this circumstance," he said.
After the outbreak came to light, regulators found a host of potential sources of contamination at the pharmacy, including standing water, mold and dirty equipment. The business filed for bankruptcy after it was bombarded with hundreds of lawsuits from victims or their heirs.
Acting Associate Attorney General Stuart Delery said the defendants showed "not only a reckless disregard for federal health and safety regulations, but also an extreme and appalling disregard for human life."
Pharmacy Owners Arrested In Fungal Meningitis Breakout That Killed 64
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