Employees of the New England Compounding Center are expected to soon begin testifying about the role that pharmacy played in the fungal meningitis outbreak. A federal grand jury in Boston has issued subpoenas as part of an investigation into potential criminal charges.
Boston prosecutors may be looking to charge NECC with several crimes, including fraud, violating the FDA act by selling tainted medication, and defrauding Medicare and Medicaid. NECC’s managing pharmacist, Barry Cadden, previously invoked his Fifth Amendment right during questioning by Congress in late 2012.
There are now 70 lawsuits against NECC, and dozens more are winding their way through the system, with an estimated 400 cases against the compounding company. NECC has asked that all the fungal meningitis lawsuits be consolidated before Boston’s U.S. District Judge Dennis Saylor.
Judge Saylor granted a request for a temporary consolidation of one dozen fungal meningitis lawsuits, and advised NECC to preserve all evidence now that the company’s offices and laboratories are shut down.
To date, more than 650 people have been sickened by the tainted steroid shots which inadvertently contained a rare form of fungal meningitis. The lawsuits filed are alleging that NECC produced a defective and dangerous product due to negligent practices and conditions. At least 40 people have died.
In a recent filing in U.S. Bankruptcy Court, Boston, a federal bankruptcy court official stated that “gross mismanagement” by NECC officers led to the fungal meningitis outbreak.
Meanwhile, in early January 2013, attorneys for NECC sent a letter to the janitorial company which provided cleaning services to NECC’s laboratories, demanding that it take legal responsibility for the tainted steroids. UniFirst’s “Uniclean” business provided what NECC’s attorneys characterized as “limited, once-a-month cleaning services” for the compounding company’s cleanroom facilities. UniFirst responded with a statement that the claim was “without merit.”
The cleaning services that were requested by NECC consisted of two UniClean techs cleaning cleanrooms for ninety minutes once a month, using NECC’s own cleansing solutions, UniClean stated. UniClean claims that its services did not have anything to do with NECC’s day-to-day operations, the overall cleanliness of the facilities, or the sterility of the products produced there.
As part of their investigation, inspectors with the CDC and FDA examined other unopened vials manufactured at NECC and found additional bacterial contamination.