Cadden is charged with 25 counts of second-degree murder — a fraction of the number of people who were injured in the largest-ever U.S. criminal case over contaminated medicine.
Lawyers can “allude to the fact” that more than 25 people died, but they can’t tell the jury how many people were actually infected, according to U.S. District Judge Richard G. Stearns.
In opening statements this morning, Cadden’s lawyer said it was “isolated” instances of human error that led to contaminated drugs being sent out.
Prosecutors for the U.S. Attorney’s Office said, “It’s a story about greed, it’s a story about cutting corners, it’s a story about fraud.”
Cadden co-owned the pharmacy but did not make the drugs. He faces life imprisonment if convicted, and pleaded not guilty.
U.S. authorities shut down the pharmacy in 2012 after an outbreak of fungal meningitis killed 44 people and sickened at least 678 others in 20 states, according to the U.S. Centers for Disease Control (CDC).
The pharmacy illegally shipped 17,000 vials of fungus-contaminated steroid injections to medical facilities throughout the U.S. for treating back pain and aching joints.
Barry Cadden and his brother-in-law Greg Conigliaro co-founded the pharmacy — New England Compounding Center (NECC) — in 1998, just months after Congress relaxed FDA regulation of the compounding industry.
Conigliaro already had a trash recycling business in an old industrial building in Framingham, Massachusetts. On the opposite side of the same building, NECC compounded highly-sensitive pharmaceutical drugs and shipped them nationwide.
The recycling facility had its own problems — a massive trash fire in 2009 and complaints about dust and smells — but the bigger problem was ongoing sterility issues at NECC.
Compounding pharmacies are usually small businesses where pharmacists fill prescriptions to customize medications for specific patients — i.e, turning a pill into a liquid.
Instead, prosecutors say NECC made up prescriptions for patients named “Big Baby Jesus” and “Donald Trump” to justify mass-producing drugs and shipping them across state lines.
In 2002, after a patient in New York died of meningitis after receiving a tainted anti-inflammatory injection from NECC, inspectors with the FDA visited the pharmacy and met Cadden.
FDA inspectors wrote that “he was no longer willing to provide us with any additional records,” and “this FDA inspection could not proceed to any definitive resolution.”
When the agency told him to shut down and fix sterility issues, Cadden complained that the FDA did not have authority. The Massachusetts Pharmacy Board allowed him to continue operations. The FDA sent another warning in 2006, to no avail.
Records show the company’s revenue skyrocketing as Cadden supplied drugs to a growing number of hospitals. Sales jumped from $19.9 million in 2010 to $32.4 million in 2012, although NECC shut down three-quarters of the way through the year.
In June 2012, the Colorado Board of Pharmacy alerted Massachusetts that NECC distributed compounded drugs to hospitals in Denver from 2010-2012 without patient-specific prescriptions, violating licenses in both states. The Massachusetts Board of Pharmacy did not respond.
Three months later, NECC medications were blamed on an outbreak of fungal meningitis, spinal infections, epidural abscesses, and joint infections at dozens of hospitals nationwide. All medications were recalled in October 2012.