An owner and top pharmacist at a New England firm have been indicted on 25 counts of second-degree murder for allegedly producing tainted steroids that were widely used to treat back pain but instead caused a deadly nationwide fungal meningitis outbreak in 2012, the Justice Department announced Wednesday. A federal grand jury also charged a dozen others associated with the pharmacy with criminal charges.
The Centers for Disease Control and Prevention has said that 64 people died in the outbreak in which 751 people in 20 states were diagnosed with a fungal infection after receiving injections of MPA, a steroid made by the New England Compounding Center based in Framingham, Mass., department officials said.
The case marks one of the most extensive criminal prosecutions over a tainted drug in U.S. history.
Prosecutors unsealed a 131-count indictment charging Barry Cadden, 48, of Wrentham, Mass., who is the owner and head pharmacist of the firm, and its supervisory pharmacist, Glenn Chin, 46, with second-degree murder in connection with deaths in Florida, Indiana, Maryland, Michigan, North Carolina and Virginia. If convicted of the charges, both men face up to life in prison.
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Before the announcement, authorities fanned out to arrest Cadden, Chin and nine of the others charged with crimes ranging from racketeering and mail fraud to violations of the Food, Drug and Cosmetic Act. Three others are expected to turn themselves in shortly, authorities said.
Others charged include majority shareholder Carla Conigliaro, 51, of Dedham, Mass., her husband, Douglas Conigliaro, 53, six pharmacists, the firm’s director of operations, its national sales director, an unlicensed pharmacy technician and one other individual.
“As alleged in the indictment, these employees knew they were producing their medication in an unsafe manner and in insanitary condition, and authorized it to be shipped out anyway, with fatal results,” Attorney General Eric Holder said. He said pharmacy officials are being held accountable for “grievous wrongdoing.”
A second-degree murder charge generally does not require prosecutors to prove that Cadden and Chin had specific intent to kill the 25 patients, but rather requires proof that they acted with extreme indifference to human life. The indictment alleges they knew their firm was making MPA in a manner and environment that prevented them from ensuring the drug was sterile, even though they knew that if the steroid could be lethal if it was contaminated.
Company pharmacists in turn failed to properly sterilize the company’s drugs and to test them for sterility, the indictment charges.
It alleges that the company also sought to avoid federal inspections by claiming to be a pharmacy that dispensed patient-specific prescriptions, when it was actually shipping drugs in bulk to hospitals, doctors and pain clinics without valid prescriptions. To throw regulators off the track, the pharmacy resorted to issuing fake prescriptions, some in celebrities’ names, the indictment says.
In addition, it charges that the Conigliaros transfered about $33.3 million to eight bank accounts after the meningitis outbreak drove the firm into bankruptcy in an attempt to shield their assets from creditors or victims who sue.
Acting Associate Attorney General Stuart Delery, appearing at a news conference in Boston, said that besides those who died, many of those infected “suffered serious, life-altering consequences.”
He said the lengthy investigation, which began in October 2012, “uncovered widespread, sustained and systemic unlawful conduct that ... was not only condoned, but was explicitly directed by management and senior pharmacists.”
Cadden and Chin were charged with second-degree murder under the Racketeer Influenced and Corrupt Organizations Act, Delery said.
The alleged actions “display not only a reckless disregard for federal health and safety regulations, but also an extreme and appalling indifference to human life,” he said.
The 2012 outbreak led to a crackdown on sterile drug production by the Food and Drug Administration. The agency’s inspectors and state officials have since conducted more than 175 inspections of facilities that compound drugs to ensure that each firm’s drug production is sterile, FDA Commissioner Margaret Hamburg said.
She said that “drugs labeled as sterile are used in ways that could greatly compromise patient care and safety ifthey aren’t actually sterile.”
“Our findings uncovered a variety of problems with sterile drug production practices at these facilities,” leading numerous firms to stop making sterile drugs and resulting in revocation or suspension of some pharmacy licenses, Hamburg said. She said that many drug products were recalled because they had been made in “substandard conditions.”
In addition, the FDA has begn implementing the Drug Quality and Security Act, which Congress passed last year in response to the meningitis outbreak. It not only imposes new requirements for good manufacturing practices on state-licensed pharmacies that compound drugs, but also imposes them on so-called “outsourced” facilities that are contracted to make the steroids.