Dec 17, 2014 11:29 AM
14 charged for roles in meningitis outbreak
The Associated Press
BOSTON (AP) In the biggest criminal case ever brought in the U.S. over contaminated medicine, 14 owners or employees of a Massachusetts pharmacy were charged Wednesday in connection with a 2012 meningitis outbreak that killed 64 people.
The nationwide outbreak was traced to tainted drug injections manufactured by the New England Compounding Pharmacy of Framingham.
Barry Cadden, a co-founder of the business, and Glenn Adam Chin, a pharmacist who was in charge of the sterile room, were hit with the most serious charges, accused in a federal racketeering indictment of causing the deaths of patients in several states by "acting in wanton and willful disregard of the likelihood" of death or great bodily harm.
Among other things, Cadden, Chin and others were accused of using expired ingredients in drugs, failing to properly sterilize drugs and failing to test drugs to make sure they were sterile.
The others face charges such as fraud and interstate sale of adulterated drugs.
More than 750 people in 20 states were sickened about half of them with a rare fungal form of meningitis, the rest with joint or spinal infections and 64 died. The steroids given were for medical purposes, not for body building; most patients received the injections for back pain.
U.S. Attorney Carmen Ortiz said the owners and employees put production and profit over safety.
"Actions like the ones alleged in this case display not only a reckless disregard for federal health and safety regulations, but also an extreme and appalling disregard for human life," Assistant U.S. Attorney General Stuart Delery said.
In reaction to the outbreak, Congress last year increased federal oversight of so-called compounding pharmacies, which custom-mix medications in bulk and supply them directly to hospitals and doctors. Compounding pharmacies are not subject to the same tight regulations and federal oversight as retail pharmacies.
Linda Nedroscik of Howell, Michigan, said her husband, John, survived the tainted injection. But she said the 64-year-old "still struggles, has nightmares."
"It's hard to say it's a relief because it doesn't change anything for us in our physical lives," she said of the indictment, "but it takes a burden off emotionally."
Chin's lawyer, Stephen Weymouth, said he was stunned that prosecutors charged his client with second-degree murder under the racketeering law.
"He feels hugely remorseful for everything that's happened for the injuries and the deaths but he never intended to cause harm to anybody," Weymouth said. "It seems to be a bit of an overreach."
Messages were left for lawyers for 11 other defendants. Lawyers for two of the defendants could not immediately be located.
The pharmacy gave up its license and filed for bankruptcy after it was flooded with hundreds of lawsuits filed by victims and their families.
The Food and Drug Administration has cited numerous unsafe practices at the pharmacy. An FDA agent also said pharmacy technicians were instructed to falsify logs to show that rooms were properly cleaned when they had not been.
The contaminated medication was discovered in the fall of 2012. Regulators later found a host of potential contaminants at the company's Framingham plant, including standing water, mold and dirty equipment.
Gregory Conigliaro, another co-founder, was among 12 of the 14 arrested at their homes around the state.
Chin, a former supervisory pharmacist, had been charged with mail fraud in September.
All those charged were expected to make an initial court appearance later Wednesday.
NECC was founded in 1998 by brothers-in-law Cadden and Conigliaro. Cadden earned a pharmacy degree from the University of Rhode Island. Conigliaro is an engineer.
Associated Press Writer Jeff Karoub reported from Detroit.