Hospitals, Pharma

Federal prosecutors charged 14 people following deadly meningitis outbreak from tainted meds

On Wednesday, a co-owner of a Massachusetts compounding pharmacy and its supervising pharmacist were charged after […]

On Wednesday, a co-owner of a Massachusetts compounding pharmacy and its supervising pharmacist were charged after a meningitis outbreak killed dozens of people in a multiple states. The outbreak was a result of tainted steroids given to patients from the company in 2012.

In 20 states, more than 750 patients contracted fungal infections following injections of preservative-free methylprednisolone acetate, or MPA, produced by New England Compounding Center (NECC), according to The Washington Post. When 64 of the patients died as a result, it became  the deadliest meningitis outbreak in U.S. history.

Barry J. Cadden, a founder and owner of NECC, and Glenn A. Chin, who oversaw production and personnel in the firm’s “sterile clean rooms,” face 25 charges of second-degree murder in the deaths of patients in seven states, including Maryland and Virginia. A dozen other people associated with NECC, including six pharmacists, the director of operations, the national sales director and two of the company’s other owners, were charged with a range of crimes, including racketeering, mail fraud, conspiracy, and violating federal food and drug laws.

As a result of the tragic incidents, NECC stopped operations, declared bankruptcy in 2012 and later agreed to a settlement of more than $100 million with creditors and victims. The whole situation also motivated Congress to pass legislation allowing the FDA to have broader authority concerning compounding pharmacies (these large-scale manufacturers were previously operating without much regulation). But even after all of that, federal officials still wanted to move forward with a criminal investigation.

The Washington Post spelled out how things unfolded:

In September, authorities arrested Chin as he tried to board a flight to Hong Kong at Boston’s Logan International Airport, charging him with mail fraud for his alleged role in shipping a batch of injections to a pain clinic in Michigan. Investigators accused Chin of overseeing unsanitary practices such as inadequate sterilization of equipment. They claimed he instructed subordinates to fraudulently fill out logs showing clean rooms had been properly maintained, even when the company’s own testing showed the presence of bacteria and mold.

Things took an even bigger turn for the worse when additional, more serious charges were brought to Chin and Cadden. They could face life in prison if they are convicted for second-degree murder.

A 131-count indictment also listed an array of alleged wrongdoings against NECC employees, many of whom were arrested at their homes early in the day by law enforcement officials. The indictment details repeated failures to ensure that drugs labeled as sterile actually were, accuses the company of dispensing drugs in bulk without valid prescriptions, and accuses the firm’s majority shareholder and her husband of illegally transferring more than $33 million among numerous bank accounts after NECC declared bankruptcy.

U.S. Attorney Carmen Ortiz called this the biggest criminal case ever brought in the U.S. over contaminated medicine.

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