The owner of the Massachusetts-based drug compounding center who was blamed for a meningitis outbreak that sickened hundreds and killed dozens nationwide was sentenced to nine years in federal prison Monday.
Barry Cadden, the head of the New England Compounding Center, was responsible for “the largest public health crisis ever caused by a pharmaceutical product,” authorities said. But he received a sentence much more lenient than the 35 years federal prosecutors requested.
“Barry Cadden put profits ahead of patients,” said Chad Readler, acting assistant attorney general of the Justice Department’s Civil Division. “Under his direction, employees assured customers that they were getting safe drugs, while Cadden ignored grave environmental failures, used expired active ingredients, and took innumerable other production shortcuts that led to numerous, entirely preventable deaths.”
Cadden was convicted in March of racketeering, racketeering conspiracy, mail fraud, and a count of introduction of misbranded drugs into interstate commerce with the intent to defraud and mislead.
But he was acquitted of second-degree murder charges.
The NECC manufactured shipments of preservative-free injectable methylprednisolone acetate, or MPA, a steroid that has various uses, including treating arthritis, and disorders of the blood and immune system, among other applications.
But in 2012, the doses caused fungal infections: a total of 753 patients in the United States were sickened to the tainted doses.
Sixty-four people died.
According to court documents, Cadden purposely continued shipments of the contaminated MPA to customers. He also authorized shipping drugs that hadn’t been tested for sterility – and never notified customers who had received shipments of non-sterile batches, according to prosecutors. Some drugs were made with expired ingredients, and others were produced by a technician who was unlicensed, authorities said. Cadden and the company also attempted to dodge FDA oversight, even going so far as dispense drugs in bulk under fake prescriptions using celebrity names “Michael Jackson” and “Diana Ross,” among others.
The victims’ family members read statements in the courtroom before U.S. District Judge Richard Stearns, who imposed sentence. Rachelle Shuff, of Indiana, told the courtroom how she nearly died after a steroid shot following a severe car crash. Since then, the meningitis caused unending chronic pain, vomiting, memory loss, frequent falls, and other suffering, Shuff said.
“I will die imprisoned in my body,” she said.
“Who gave him the right to play God?” asked Penny Laperriere, a Michigan woman whose husband died of the meningitis complications.
Cadden’s attorneys asked for a maximum of three years in prison. After Monday’s sentencing, he remains free on bond – but is asked to report to prison by Aug. 7.
Cadden was tearful as he read his own statement, according to those present in the courtroom.
“I am sorry for the whole range of suffering that resulted from company’s drugs,’ he said.
Authorities said the NECC “tragedy” has changed pharmaceutical oversight.
“Protecting Americans from unsafe and contaminated drugs is at the core of our mission,” said Scott Gottlieb, the FDA commissioner. “Patients should not have to worry about the safety and sterility of the drugs they are prescribed.”
But changes have been made in the ensuring five years, Gottlieb added.
“Since this tragedy, Congress has given the FDA important new authorities, and the agency has implemented key policies, all to prove a greater assurance of safety over compounded medicines.”
The Associated Press contributed to this report.