Barry Cadden, Racketeering, Massachusetts 2017

BOSTON, Massachusetts – In a major blow to public health, Barry Cadden, the owner and head pharmacist of New England Compounding Center (NECC), has been sentenced for his role in the 2012 nationwide fungal meningitis outbreak.

Cadden, 50, was sentenced by U.S. District Court Judge Richard G. Stearns to 108 months in prison and three years of supervised release, and forfeiture and restitution in an amount to be determined later. In March 2017, Cadden was convicted by a federal jury of racketeering, racketeering conspiracy, mail fraud and introduction of misbranded drugs into interstate commerce with the intent to defraud and mislead.

“Barry Cadden put profits over patients,” said Acting United States Attorney William D. Weinreb. “He used NECC to perpetrate a massive fraud that harmed hundreds of people. Mr. Cadden knew that he was running his business dishonestly, but he kept doing it anyway to make sure the payments kept rolling in. Now he will have to pay for his crimes.”

According to court documents, Cadden directed and authorized the shipping of contaminated methylprednisolone acetate (MPA) to NECC customers nationwide. He also authorized the shipping of drugs before test results confirming their sterility were returned, never notified customers of nonsterile results, and compounded drugs with expired ingredients. Furthermore, certain batches of drugs were manufactured, in part, by an unlicensed pharmacy technician at NECC.

In 2012, 753 patients in 20 states were diagnosed with a fungal infection after receiving injections of preservative-free MPA manufactured by NECC. Of those 753 patients, the U.S. Centers for Disease Control and Prevention (CDC) reported that 64 patients in nine states died. The outbreak was the largest public health crisis ever caused by a pharmaceutical product.

Cadden’s sentencing is a significant step towards justice for the victims of the outbreak. “Today, Barry Cadden was held responsible for one of the worst public health crises in this country’s history, and the lives of those impacted because of his greed, will never be the same,” said Harold H. Shaw, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division.

The case against Cadden was a joint effort between the FBI, the FDA, and other law enforcement agencies. “Protecting Americans from unsafe and contaminated drugs is at the core of our mission. Patients should not have to worry about the safety and sterility of the drugs they are prescribed,” said FDA Commissioner Scott Gottlieb, M.D.

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