Ruminations

Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Wednesday, November 22, 2017

Deliberate Negligence

"He knew he was making nonsterile drugs. Glenn Chin just didn't care."
Assistant U.S. Attorney Amanda Strachan

"The underlying factor is that the company got greedy and overextended and we got sloppy, and something happened,"
"We became a manufacturer overnight. So we were basically trying to have the best of both worlds." "We were going to hurt a patient. We were just thinking hurt a patient. We weren't compounding anymore, we were manufacturing."
Joe Connolly, NECC lab technician

"[It was] a complete investigatory failure on the part of the FDA [U.S. Food and Drug Administration]. The FDA could not determine the route of contamination. That was what their job was."
"Glenn Chin didn't know how to supervise anybody. Glenn Chin was not competent to do that job. Glenn Chin would do anything and everything Barry Cadden told him to do."
"Negligence, even gross culpable negligence, is not enough to support a second-degree murder conviction."
Stephen Weymouth, lawyer 
Barry Cadden, president of the New England Compounding Center, was sentenced to nine years in prison for his role in the deadly outbreak. (Stephan Savoia/AP)
Barry Cadden, president of the New England Compounding Center, was sentenced to nine years in prison for his role in the deadly outbreak. (Stephan Savoia/AP)

When the month-long trial of the owner and the supervisor of the New England Compounding Center in Framingham, Massachusetts concluded, Assistant U.S. Attorney Amanda Strachan gave her summation, then showed the jury photographs of 25 people, victims of contamination in supposedly sterile drugs who succumbed to fungal meningitis, people who lived in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia.

Glenn Chin whose position it was to supervise 20 people at the compounding center, faced a life sentence if he was convicted on a number of charges, including second-degree murder. Glenn Chin was described during trial procedures as the right-hand man of the person who had, with his wife, founded the New England Compounding Center, in 1998. Barry Cadden, that man, also faced trial on the same charges.

In March he was convicted on charges of conspiracy, mail fraud and racketeering, but acquitted on the charge of second-degree murder. He faces nine years in prison. Former NECC employees testified that cleaning logs were falsified, untested drugs shipped without alerting doctors and patients. The facility had a "clean room" where drugs were produced and it was there that deadly mold took hold when cracks in the floor became their breeding ground.

Despite knowing that the drugs the center was shipping off to doctors for use on their patients were compromised, Mr. Chin signed off on contaminated drugs to meet the pressure of client demand for the products produced by NECC. Chin and Cadden did more than cut corners; they made use of expired medication, mislabeled drugs and took to distributing drugs they well knew could be fungus-tainted.


(Cadden hired unqualified staff, ordering employees to cut corners for increased production and profit.
When Chin was hired in 2004, he also had no professional experience in compounding drugs or sterilization, learning everything from Cadden.)


That situation led to an outbreak of fungal meningitis. The disease claimed 76 lives and up to 700 infectious illnesses right across the country. Lawyer Weymouth informed jurors of a 2012 investigation by the U.S. Food and Drug Administration which failed to reveal the source of the contamination. One microbiologist  with the investigating team took swabs of the center's roof and boiler room, but missed samples of the clean room where medications were produced.

The Compounding Center advertised itself to doctors and hospitals as trustworthy, and the best compounding pharmacy in the country. It became such a trusted source of medications it could barely keep pace with the orders country-wide as the compounding pharmacy made and shipped drugs filling orders that hugely profited the center. While in reality some of those drugs were contaminated with a deadly mould.

The center was not the sterile, reliable, trustworthy place its owner claimed it to be. It was plagued by bugs and mice and for a facility that was expected to observe punctilious cleanliness to ensure its products were unfailingly beyond reproach, it was instead, filthy. The jury was informed that Chin had time and again ignored warning signs that the "clean room" had become a source of contamination.

The technicians working there claimed to have been intimidated by their supervisor, Glenn Chin, who followed orders from the owner, Barry Cadden. Sales representatives of the center assured medical centers, doctors and hospitals for years that the compounding center hired registered, trained technicians, and all medication was tested ensuring sterility, then place in quarantine before being shipped off. All these assurances were simply figments of imaginary assurances.

The contaminated injections of medical steroids which lead to an outbreak of fungal meningitis and other infections mostly affected people with back pain for whom the steroids were meant, with the result that 700 people in 20 states became ill in the most serious public health crisis in recent U.S. medical history. According to the federal Centers for Disease Control and Prevention, 64 people died as a result in 2012, while federal officials raised the total number of deaths to 76.

When the jurors returned with their verdict it was to find the supervisory pharmacist who oversaw the clean room and where he himself formulated the drugs in the mold-contaminated room that spread to the medication, not responsible for the deaths of people who wee injected with those contaminated drugs. They held that prosecutors had failed to prove beyond a doubt that Mr. Chin was responsible.
Glenn Chin, the supervisory pharmacist at the now-closed New England Compounding Center, departs federal court after attending the first day of his trial on Sept. 19. (Steven Senne/AP)
Glenn Chin, the supervisory pharmacist at the now-closed New England Compound Center, departs federal court after attending the first day of his trial on September 19.  Steven Senne/AP

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