Using nonsterile labs for injections and infusions:
"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, Massachusetts.
The pain medicine in question — preservative-free methylprednisolone acetate — harboured fungal meningitis.
The two pharmacists, New England Compounding Center co-owner Barry Cadden and supervisory pharmacist Glenn Chin, along with 12 others named in the 131-count indictment, "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," said US Attorney General Eric Holder in a news release.
All told, 751 patients in 20 states were infected with fungal meningitis after receiving methylprednisolone acetate shots produced by the now-defunct compounding pharmacy in Framingham, Massachusetts, according to the Centers for Disease Control and Prevention. Sixty-four of those patients died. In response, the US Food and Drug Administration has conducted more than 175 inspections of compounding facilities during the last 2 years to prevent similar outbreaks.
The 14 defendants in the federal case, who include a total of 8 pharmacists and two pharmacy technicians, are accused of introducing misbranded drugs into interstate commerce and other crimes, in addition to the murder charges facing Cadden and Chin.
The second-degree murder charges are framed as racketeering acts, according to the Department of Justice. 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, the Department of Justice stated.
The indictment holds Cadden, Chin, and others responsible for, among other things:
- 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.
Cadden and several other defendants also are charged with pretending to dispense drugs on the basis of patient-specific prescriptions — what Massachusetts law requires of a pharmacy — when they actually were functioning as a drug manufacturer, distributing their product in bulk to customers. Fake prescriptions often bore the names of celebrities and fictional characters, such as Chris Rock, Wonder Woman, Bill Clinton, Harry Potter, and Jennifer Lopez.
If convicted on all counts, Cadden and Chin could be sentenced to life in prison, according to the Department of Justice. Stephen Weymouth, an attorney for Chin, said his client will plead not guilty.
"I am shocked almost beyond words that they brought back an indictment against him...that include second-degree murder," Weymouth told Medscape Medical News. "It's just overreaching on the part of the government. We fully intend to defend this case."
Bruce Singal, Cadden's attorney, said in a statement issued to Medscape Medical News that the fungal meningitis outbreak caused by the New England Compounding Center drugs was a "terrible human tragedy." However, "not every accident, and not every tragedy, are caused by criminal conduct."
"The US Attorney's Office should not indict people over the tragic consequences of noncriminal behaviour," said Singal. "And it should not wage a public relations campaign to vilify citizens who have been found guilty of nothing."