A co-owner of a Massachusetts compounding pharmacy and its supervising pharmacist were indicted on federal charges Wednesday in connection with a multistate meningitis outbreak that killed dozens of patients who had received tainted steroids from the company in 2012.
Barry J. Cadden, a founder and owner of New England Compounding Center (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.
“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,” Stuart F. Delery, acting associate U.S. attorney general, told reporters at a news conference in Boston.
More than 750 patients in 20 states contracted fungal infections after receiving injections of preservative-free methylprednisolone acetate, or MPA, produced by NECC, according to investigators. Of those, 64 died, making the incident the deadliest meningitis outbreak in U.S. history.
As the depth of the devastation from the tainted injections came to light, NECC faced a flood of lawsuits, suspended its operations and declared bankruptcy in late 2012. Earlier this year, the company’s owners agreed to
a settlement of more than $100 million with the company’s creditors and with victims of its contaminated products.
In the wake of the deadly outbreak, Congress also passed legislation granting the Food and Drug Administration broader authority to oversee compounding pharmacies, though not as much power as the agency initially sought.
Traditionally, such pharmacies were small outfits mixing drugs for individual patients, but over time some of them grew into large-scale manufacturers of drugs that operated largely without regulation.
Even after the congressional action, and as the company entered a settlement, federal officials insisted they were pressing forward with a criminal investigation.
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.
Wednesday brought even more serious charges for Chin and Cadden, who could face life in prison if convicted on the second-degree murder charges. 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.