Federal prosecutors charged 14 people in a 2012 meningitis outbreak that killed 64 people nationwide in what authorities called the largest criminal case ever brought in the U.S. over contaminated medicine.
The co-founders, pharmacists and pharmacy technicians at a Massachusetts compounding pharmacy are accused of using expired ingredients and failing to follow standards for cleanliness at the now-closed New England Compounding Center in Framingham, which is blamed for tainted steroids that caused the deadly outbreak.
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According to an indictment announced Wednesday, mold and bacteria were in the air and on workers' gloved fingertips. Pharmacists were accused of failing to test drugs for purity before sending them to hospitals and pain clinics.
The most serious charges in the federal racketeering indictment were leveled against Barry Cadden, one of the pharmacy's co-founders, and Glenn Adam Chin, a supervisory pharmacist, who were accused in a 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.
U.S. Attorney Carmen Ortiz said NECC was "filthy" and failed to comply with even basic health standards, and employees knew it. "Production and profit were prioritized over safety," she said.
More than 750 people in 20 states fell ill — about half of them with a rare fungal form of meningitis, the rest with joint or spinal infections — after getting steroid injections, mostly for back pain. Sixty-four died.
In reaction, Congress last year increased federal oversight of so-called compounding pharmacies like NECC, which custom-mix medications in bulk and supply them directly to hospitals and doctors.
Cadden's lawyer, Bruce Singal, complained that prosecutors are trying to turn a "tragic accident" into a federal crime.
"Not every accident, and not every tragedy, are caused by criminal conduct," Singal said in a statement.
Chin's lawyer, Stephen Weymouth, said he was stunned that prosecutors charged his client with second-degree murder under the racketeering law.
"He feels hugely remorseful for everything that's happened — for the injuries and the deaths — but he never intended to cause harm to anybody," Weymouth said. "It seems to be a bit of an overreach."
Lawyers for the other defendants did not immediately return calls.
John Nedroscik, 64, of Howell, Michigan, received the tainted steroids while getting treatment for damaged discs in his back. He contracted a fungal infection that caused an abscess on his spine.
He spent nearly a month in the hospital for surgery to remove the abscess and then had to return frequently for a string of problems. He said he still takes pain medication and has trouble sleeping.
"I still struggle with some stuff," he said. But "it could have been a lot worse."
Cadden and Chin were ordered held in custody until a bail hearing on Thursday. The others were released on bail pending trial.
Gregory Conigliaro, who founded the business in 1988 with Cadden, his brother-in-law, was among those charged.
The federal law used against Cadden and Chin, the Racketeer Influenced and Corrupt Organizations Act, originally was aimed at organized crime but has been applied in white-collar prosecutions and many other kinds of cases over the years.
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.
The center filed for bankruptcy after it was bombarded with hundreds of lawsuits from victims or their families.