The sterile products fungal meningitis contamination issue represented the worst case of contaminated medicinal products (intended to be sterile) in pharmaceutical history. The story was first reported by Digital Journal back in 2012 and it has taken five years for the case to go through the legal process.
The incident relates to a contaminated steroid product manufactured by the New England Compounding Center (NECC) and distributed across 23 U.S. states as a cure for arthritis (the medicine is used to treat pain and swelling that occurs with arthritis and other joint disorders; with the affected batches, in the majority of cases the drug product was administered as a spinal injection). The contaminated products, due to a series of failures of Good Manufacturing Practice (GMP), caused 76 deaths and, it was estimated by the U.S. Centers for Disease Control and Prevention, over 700 other people to suffer life changing and debilitating injuries.
The product was methylprednisolone acetate (80mg/ml), which was designed to be an injectable steroid. The product was compounded by the NECC from vials into syringes. The NECC was based in Framingham, Massachusetts. The BBC noted at the time that the majority of the cases were in Tennessee. The reason for the contamination was traced to several fungi; the predominant fungus identified in patients was a melanized mold called Exserohilum rostratum.
The incident led to a reform of rules affecting many pharmaceutical compounders, which then fell under U.S. state laws rather than under the watch of the U.S. Food and Drug Administration. This divergence in standards was picked up by international contamination control expert Barry Friedman, who remarked that the NECC issue raised wider questions about the control and regulation of compounding pharmacies. Reforms were later put in place, as Digital Journal reported in November 2013 President Barack Obama signed into law a bill that granted the U.S. Food and Drug Administration (FDA) increased regulatory powers over drug compounding pharmacies.
In 2013 a congressional hearing was held. Here Barry Cadden, owner and director of the company, was summoned but, according to CNN, he refused to answer questions, citing his constitutional right to remain silent. Following this, in December 2014, the two co-founders of the NECC facility along with 12 other former employees of the Massachusetts compounding pharmacy were arrested. One charge leveled against the co-owners was of second-degree murder.
Now, with the process at an end, Cadden was found guilty by jury in March 2017 and in June U.S. District Judge Richard Stearns sentenced Barry Cadden to nine years in prison for the sterile products contamination incident. With sentence passed, Claden said: “I am so sorry for your extraordinary losses. I am sorry for the whole range of suffering that resulted from my company’s drugs.”
During the trial, prosecutors stated that Cadden, aged 50, ran the center in a dangerous way by avoiding some industry regulations, especially those that would safeguard sterility. This was allegedly to push production and make more money.
NECC no longer exists, the pharmacy filed for bankruptcy after getting hit with hundreds of lawsuits and it paid out some $200 million in compensation to affected families and survivors.
