Good morning, and thank you all for being here. I am joined today by United States Attorney [Carmen] Ortiz, of the District of Massachusetts; Assistant Attorney General [Joyce] Branda, of the Justice Department’s Civil Division; Deputy Commissioner [Howard] Sklamberg, of the Food and Drug Administration; Attorney General Bill Schuette, of Michigan; and leaders from the FBI and the Departments of Defense and Veterans Affairs.
We are here to announce a significant law enforcement action that will hold accountable those allegedly responsible for grievous wrongdoing. Every patient receiving medical treatment deserves the peace of mind and knowledge that the medicine they are receiving is safe. When people and companies violate that trust and break the law, through conduct as alleged in the indictment that we are announcing today, the consequences to patients and their families can be catastrophic.
That is why it remains a priority of the Department of Justice to use every tool at our disposal to protect patients’ health and safety and to hold those responsible accountable. We will never rest in our determination to protect American consumers from harm and to bring justice for the victims.
As of this morning, federal agents have arrested 11 individuals on criminal charges relating to their alleged roles in the conduct of the New England Compounding Center, or NECC. Three others have also been charged. NECC was a business that produced drugs for hospitals, doctors, and pain clinics. Some of the drugs that it produced – including batches, or “lots,” of a purportedly sterile injectable steroid used to treat back pain, commonly referred to as “MPA” – were found to be contaminated with fungus. Those contaminated lots led to a 2012 outbreak of fungal meningitis throughout the nation, during which more than 700 individuals from 20 states were infected. Many suffered serious, life-altering health consequences. And, according to the CDC, 64 individuals from 9 states who received the drug ultimately died as a result.
Our criminal investigation into these incidents – which began in October 2012, and was led by the U.S. Attorney’s Office for the District of Massachusetts and the Civil Division’s Consumer Protection Branch – uncovered widespread, sustained, and systematic unlawful conduct at NECC that, as alleged in the indictment, was not only condoned, but was explicitly directed by management and senior pharmacists. This conduct included grossly insufficient and unsanitary production practices, as well as fake prescriptions that were used to mislead regulators.
The individuals who oversaw NECC’s operations and who supervised its drug manufacturing have been charged with second degree murder under the Racketeer Influenced and Corrupt Organizations Act, or RICO. Those individuals and others, including former NECC managers, pharmacists, and shareholders, are also facing other charges that include contempt, sale of misbranded drugs, sale of adulterated drugs, conspiracy to defraud the federal government, and mail fraud.
Let me be clear: actions like the ones alleged in this case display not only a reckless disregard for federal health and safety regulations, but also an extreme and appalling indifference to human life. American consumers have a right to know that their medications are safe to use and safe to give to their families. And this case proves that the Department of Justice will always stand resolute to ensure that right; to protect the American people; and to hold wrongdoers accountable to the fullest extent of the law.
I want to thank Carmen Ortiz, her colleagues in the U.S. Attorney’s Office for the District of Massachusetts; the Civil Division’s Consumer Protection Branch; the FBI’s Financial Crimes Section; the Defense Department’s Criminal Investigative Service; the Department of Veterans Affairs Office of the Inspector General; and the state attorneys general who contributed to this result for their leadership in this investigation, as well as our partners at the Food and Drug Administration and the Department of Health and Human Services for their invaluable assistance. This case reflects a true partnership of federal and state law enforcement and public health officials, and they all deserve our gratitude.
And at this time, I’d like to introduce U.S. Attorney [Carmen] Ortiz, who will provide additional details on today’s announcement.