Two pharmacists at the notorious New England Compounding Center have been charged with second-degree murder in the deaths of 25 individuals who received non-sterile steroid pain injections in 2012 and 2013, according to a criminal indictment unsealed today in a federal district court in Boston, USA. The pain medicine preservative-free methyl-prednisolone acetate harbored fungal meningitis.
The two pharmacists, knew they were producing their medications in an unsafe manner and in unsanitary conditions.
The second-degree murder charges are framed as racketeering acts. Prosecutors generally do not need to prove that someone charged with second-degree murder specifically intended to kill someone, only that he or she acted with extreme indifference to human life. If convicted they could be sentenced to life in prison.
The charge framed are
• using expired and expiring ingredients to compound the steroid injections and falsifying expiration dates on documents,
• autoclaving drugs for less than the 20 minutes needed for sterilization,
• failing to properly test drugs for sterility,
• failing to recall tainted drugs when microbial growth was later detected,
• falsifying drug labels to conceal how expired or untested drug solution lots were mixed with other lots, and
• failing to properly clean and disinfect the "clean rooms" where the steroid injections were manufactured. Cleaning logs were falsified to state otherwise, said prosecutors.
IMA Comments: A similar charges should be framed amongst all in India who end up with substandard spurious drugs. The recent Chattisgarh sterilization case is one such example.
In India the person can be and should be booked under 304A of IPC: "Causing death by negligence.—Whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both".
The two pharmacists, knew they were producing their medications in an unsafe manner and in unsanitary conditions.
The second-degree murder charges are framed as racketeering acts. Prosecutors generally do not need to prove that someone charged with second-degree murder specifically intended to kill someone, only that he or she acted with extreme indifference to human life. If convicted they could be sentenced to life in prison.
The charge framed are
• using expired and expiring ingredients to compound the steroid injections and falsifying expiration dates on documents,
• autoclaving drugs for less than the 20 minutes needed for sterilization,
• failing to properly test drugs for sterility,
• failing to recall tainted drugs when microbial growth was later detected,
• falsifying drug labels to conceal how expired or untested drug solution lots were mixed with other lots, and
• failing to properly clean and disinfect the "clean rooms" where the steroid injections were manufactured. Cleaning logs were falsified to state otherwise, said prosecutors.
IMA Comments: A similar charges should be framed amongst all in India who end up with substandard spurious drugs. The recent Chattisgarh sterilization case is one such example.
In India the person can be and should be booked under 304A of IPC: "Causing death by negligence.—Whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both".
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