A national meningitis outbreak that killed 64 people and sickened hundreds more will be in the spotlight this week as a former co-owner of the compounding pharmacy blamed for the crisis goes on trial in federal court in Boston.
Opening statements are scheduled Monday in the trial of Barry Cadden, one of two former principals at the now-closed New England Compounding Center, charged with causing the deaths of 25 people.
Cadden is charged with second-degree murder and other crimes under the federal racketeering law. He has pleaded not guilty.
A guide to the latest developments and key background about the case:
In fall 2012, hundreds of people nationwide became ill with fungal meningitis. The outbreak was eventually traced to tainted steroid injections manufactured by the New England Compounding Center in Framingham, Massachusetts. More than 700 people in 20 states fell ill after getting steroid injections, many of them for back pain. Sixty-four people died. About half of those sickened got a rare fungal form of meningitis; the rest had joint or spinal infections. All those who died fell victim to complications of fungal meningitis. Indiana, Michigan and Tennessee were hardest hit.
After the outbreak, regulators found a host of potential sources of contamination at the pharmacy, including standing water, mold, and bacteria in the air and on workers' gloved fingertips. NECC filed for bankruptcy after it was deluged with hundreds of lawsuits from victims or their heirs. NECC and several related companies reached a $200 million civil settlement with victims and their families. In 2013, Congress increased federal oversight of compounding pharmacies, which custom mix medications for patients and supply them directly to hospitals and doctors.
In 2014, federal prosecutors charged 14 former owners, pharmacists and pharmacy technicians of NECC in connection with the tainted steroids. The racketeering indictment alleges that pharmacists failed to follow industry standards for cleanliness, used expired ingredients, and failed to test drugs for purity before sending them to hospitals and pain clinics. It also alleges that employees falsified logs to make it look as if the pharmacy's so-called clean rooms had been disinfected when they had not.
Cadden, a former co-owner, president and head pharmacist at NECC, and Glenn Chin, a supervisory pharmacist, were charged with the most serious crimes, accused of causing the deaths of 25 people in seven states by acting with "wanton and willful disregard" of the risks. They both face up to life in prison if convicted of all the charges. Chin is expected to go on trial after Cadden's trial ends.
Carla Conigliaro, NECC's majority owner, and her husband, Douglas Conigliaro, pleaded guilty to illegally transferring assets. Both were sentenced to probation and ordered to pay fines.
Robert Ronzio, NECC's sales director, pleaded guilty to conspiracy to defraud the U.S. Food and Drug Administration. Federal prosecutors have said Ronzio is cooperating with the government and is expected to testify at the trials of the other defendants. He is scheduled to be sentenced in September.
U.S. District Judge Richard Stearns dismissed charges against two other pharmacists, finding that they could not be held criminally liable because they did not dispense the drugs.
The remaining defendants are charged with fraud, interstate sale of adulterated drugs and other charges.