A former executive at a compounding pharmacy in Massachusetts is headed for trial, after the facility was deemed responsible for a national meningitis outbreak in 2012 that killed 64 and sickened over 700 people. Around half of the victims developed a rare fungal form of meningitis, while the others endured joint or spinal infections.
Barry Cadden, co-founder and head pharmacist of the New England Compounding Center in Framingham, will appear in U.S. District Court in Boston on Jan. 4. He is being charged with 25 counts of murder and other offenses under federal racketeering laws. Jury selection is expected to begin on Jan. 6.
Prosecutors in the case have said that the center used expired ingredients and did not follow cleanliness standards, which resulted in tainted steroid injections.
State officials released a report on Oct. 23, 2012, citing their findings: Water from a leaking boiler collected just outside a cleanroom; floor mats used by technicians were filled with dirt and debris; drugs were shipped out before the company even confirmed they were sterile; among other issues.
The FDA later released a copy of the FDA Form 483 issued to the New England Compounding Center, after observing and confirming contaminated products and listing a number of observations regarding conditions in the cleanroom at NECC’s facility.
Glenn Chin, the supervising pharmacist at NECC who monitored the cleanrooms, is also being charged with 25 counts of second-degree murder and racketeering charges. He will have a separate trial. Federal investigators say that he didn’t properly sterilize or test equipment and concealed the unsafe practices, and was involved in compounding the contaminated methylprednisolone acetate (MPA) that caused the outbreak. An affidavit filed in U.S. District Court alleged that Chin participated in a scheme to fraudulently cause one lot of MPA to be labeled as injectable, meaning that it was sterile and fit for human use. The lot was shipped to Michigan Pain Specialists in Brighton, Mich. After receiving the drug, Michigan Pain Specialists doctors injected it into patients, believing it to be safe. As a result, 217 patients contracted fungal meningitis, and 15 of them died, according to the affidavit.
Chin was arrested at Logan Airport on Sept. 4, 2014, as he was about to board a flight for Hong Kong.
