The outbreak of fungal meningitis related to contaminated epidural steroid injections has led to murder charges being brought against the pharmacists who produced the fatal products. Over 2012 and 2013, 751 patients are know to have been infected with fungal meningitis after receiving injections of contaminated steroids for neck pain and back pain. Of those patients, 64 died, and two pharmacists at the New England Compounding Center have been charged this week with 25 counts of second-degree murder.
The charges were revealed in court in Boston, naming the now-closed compounding center’s co-owner Barry Cadden and the supervisory pharmacist Glenn Chinn. The full indictment listed 131 chagges and named 14 people in total, including 8 pharmacists and two pharmacy technicians, as well as Cadden and Chinn. These charges include introducing misbranded drugs into interstate commerce, but the charges of second-degree murder surprised many as murder is typically viewed as a crime where the perpetrator intended to kill their victim. In fact, the law states that murder charges can be brought against those who act with extreme indifference to human life, which is why Cadden and Chinn will now face these charges in court.
Charges Against NECC Employees and Co-Owner
The outbreak occurred because the pharmacy failed on a number of levels. When producing the epidural steroids for injection (preservative-free methylprednisolone acetate), the pharmacists are accused of using expired or expiring ingredients, falsifying expiration dates, failing to properly sterilize drugs, check the drugs were sterile, recall drugs after detecting microbial growth, and to properly clean facilities. They are also alleged to have shipped out drugs they knew were not produced safely, to have falsified labels on drugs to conceal expiration dates, and to have falsified cleaning records.
FDA Inspections of Compounding Facilities
In response to these issues, the US Food and Drug Administration (FDA) has carried out over 175 inspections of compounding pharmacies since 2012. The US Attorney General Eric Holder said in a news release that the pharmacists at the center of the outbreak “knew they were producing their medications in an unsafe manner and in unsanitary conditions, and authorized it to be shipped out anyway, with fatal results”.
Epidural steroid injections are a common treatment for people with neck pain and back pain caused by persistent inflammation. These injections can help to break the cycle of inflammation and pain and allow patients to engage in physical therapy and other treatments to encourage healing and repair. There is always some danger with these injections as they involve the introduction of a needle into the spinal column, close to the spinal nerves and spinal cord.
In this case however, the patients receiving these contaminated steroids were essentially infected with a fungal agent that rapidly spread through their central nervous system, causing the classic symptoms of meningitis. Unfortunately for those with neck pain and stiffness, these are themselves symptoms of meningitis, creating a situation where patients may not have accessed treatment, or been diagnosed early enough to successfully treat the infection.
If the defendants Cadden and Chin are convicted, they could be given life sentences for their part in the deaths of at least 25 people who underwent a common, relatively simple procedure for neck pain or back pain.