A 131-count criminal indictment was unsealed Dec. 17, 2014, in Boston in connection with the 2012 nationwide fungal meningitis outbreak, the U.S. Justice Department announced.
Barry J. Cadden, owner and head pharmacist of New England Compounding Center (NECC), and NECC’s supervisory pharmacist Glenn A. Chin were charged with 25 acts of second-degree murder in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee, and Virginia.
As a general matter, and depending on particular state law, second-degree murder does not require the government to prove Cadden and Chin had specific intent to kill 25 patients, but rather that they acted with extreme indifference to human life.
Contaminated vials of preservative-free methylprednisolone acetate (MPA) manufactured by NECC, located in Framingham, MA, caused the outbreak. The CDC reported that 751 patients in 20 states were diagnosed with a fungal infection after receiving injections of NECC’s MPA. Of those 751 patients, the CDC reported 64 patients in nine states died. Patient suffering and fear was a hallmark of the outbreak as investigators worked frantically to notify any patients that may have been administered the contaminated drugs.
“This has been a devastating outbreak for patients, their families and friends, healthcare providers and clinics,” Marion Kainer, MD, director of the Healthcare Associated Infections & Antimicrobial Resistance Program at the Tennessee Department of Health in Nashville, TN, said as the outbreak unfolded in 2012. “In Tennessee, we still have many patients hospitalized and suffering from complications and others who are exposed and frightened that they may become infected.” (See also Hospital Infection Control & Prevention, Dec. 2012).
The unsafe conditions alleged in the indictment include failures to properly sterilize NECC’s drugs, to properly test the drugs for sterility, and to wait for test results before sending drugs to customers.
The unsanitary conditions alleged in the indictment include NECC’s lack of proper cleaning and failure to take any action when its own environmental monitoring repeatedly detected mold and bacteria.
Further, the NECC allegedly repeatedly took steps to shield its operations from FDA regulatory oversight by claiming to be a pharmacy dispensing drugs without valid prescriptions. The indictment alleges that NECC even used fictional and celebrity names on fake prescriptions to dispense drugs, the Justice Department reported. In fact, NECC routinely dispensed drugs in bulk without valid prescriptions.
The details contained in the indictment are allegations, the prosecutors stressed. The defendants are presumed innocent unless and until proven guilty beyond a reasonable doubt. Outbreak victims with questions may call 1 (888) 221-6023 or email [email protected].
