Two years ago, an outbreak of meningitis resulting from contaminated injections supplied by a compounding pharmacy killed 64 people. (See our blog, “Your Money or Your Life: Injury Toll From Pain Injection Drugs Climbs.“) Last week, 14 owners or employees of the New England Compounding Center (NECC) were arrested for their alleged crimes.
According to the Associated Press (AP), the most serious charges were levied against the pharmacy’s co-founder, Barry Cadden, and Glenn Adam Chin, a pharmacist in charge of the sterile room, who were accused in a federal racketeering indictment of causing the deaths by “acting in wanton and willful disregard of the likelihood.” Authorities claim that they used expired ingredients, failed to sterilize drugs and failed to test them to ensure they were sterile.
The outbreak affected more than 750 people in 20 states who contracted fungal meningitis and other illnesses from tainted steroids injections NECC had made to alleviate back pain.
Other charges ranged from mail fraud to introducing adulterated and misbranded drugs into interstate commerce. Pharmacy technicians, according to officials, were told to lie on logs about when the facilities were cleaned. Investigators found several potential contaminants at the company’s plant in Massachusetts, including standing water, mold, water droplets and dirty equipment.
The notoriety from the meningitis outbreak spurred the FDA and legislators to scrutinize more thoroughly compounding pharmacies, which customize medication for supply directly to hospitals and doctors and are not subject to the same rigorous oversight as retail pharmacies. (See our blog, “Congress Passes Compounding Pharmacy Bill.”)
The NECC filed for bankruptcy protection in the wake of multiple lawsuits.