Fourteen officials, pharmacists and technicians tied to the Massachusetts company involved in a meningitis outbreak that killed 64 people were indicted on charges including racketeering and second-degree murder.
The New England Compounding Center’s tainted drugs, including a steroid administered by spinal injection to treat pain, infected 751 people in 20 states, U.S. officials have said. The 2012 outbreak was caused by sloppy clean-room practices, including routine failure to properly sterilize drugs, according to the indictment unsealed today in Boston.
The infections tied to the Framingham-based company, also called NECC, led Congress almost a year ago to increase U.S. Food and Drug Administration oversight of compounding pharmacies, which provide health-care companies with tailored drug mixtures that aren’t commercially available.
Barry Cadden, NECC’s former president and lead pharmacist, and Glenn Chin, a supervising pharmacist who was arrested at a Boston airport in September, are accused of second-degree murder over the deaths of dozens of people in states including Indiana, Maryland and Florida. The men face as long as life in prison if convicted on all counts, the U.S. said.
“Production and profit were prioritized over safety,” U.S. Attorney Carmen Ortiz said today at a press conference. The company failed to recall drugs after bacterial growth was detected, “knowing that injection into a sensitive body part was likely to cause injury including death.”
Celebrity Names
NECC repeatedly shielded its operations from FDA oversight by claiming to dispense drugs for individual prescriptions, while actually selling the medicine in bulk, the U.S. Attorney’s Office said in a statement. The company even used fake and celebrity names on falsified prescriptions to carry out the conspiracy, prosecutors said.
“These employees knew they were producing their medication in an unsafe manner and in insanitary conditions, and authorized it to be shipped out anyway, with fatal results,” Attorney General Eric Holder said in the statement.
NECC’s facilities were in “deplorable” physical condition when they were probed by state and federal health investigators after the outbreak, according to related complaints against the company filed by victims and families.
Authorities found contaminated vials of medicine, dirty surfaces and equipment in supposedly “clean rooms” where medicine was prepared, incorrect room temperatures, leaky boilers and air contaminants, according to court papers.
‘Appalling Indifference’
The defendants, 11 of whom were arrested today, displayed “an extreme and appalling indifference to human life,” Acting Associate Attorney General Stuart Delery said at the press conference.
They are charged with engaging in a conspiracy to provide health-care companies with false and misleading information about the quality of the company’s drugs and to get rich in the process. NECC, which had 2012 revenue of about $32 million, carried out the scam nationwide, using a sales force tied to the company through a common owner.
Cadden, 48, and Chin, 46, appeared in Boston federal court today after their early morning arrests. A judge ordered them held overnight pending a decision on bail. While prosecutors argued bail should be denied, defense lawyers said the men are determined to face the charges and have nowhere to run.
Sales Operation
Two other defendants in the case, Carla Conigliaro, 51, a director of NECC and the company’s former majority shareholder, and her husband Gregory, 49, who ran the sales operation linked the pharmacy company, also appeared in court today. Lawyers for the Conigliaros sought their release to home confinement. Prosecutors said they wouldn’t oppose that.
Chin, who has already pleaded not guilty to some of the allegations, was detained in September because he was boarding a flight to China when the criminal probe into the outbreak was still under way, the U.S. said. No decision has been made.
The company, formally New England Compounding Pharmacy Inc., suspended operations and filed for bankruptcy protection in December 2012 as a result of lawsuits by victims and families. The company and its insurers in August won court approval of a settlement of almost $100 million.
License Surrendered
Shortly before it filed the Chapter 11 bankruptcy petition, the company surrendered its Massachusetts pharmacy license, recalled all its products and fired most employees, according to court records.
Also named in the indictment are Gene Svirskiy, 33, a supervising pharmacist in one of the “clean rooms” where drugs were prepared, and Robert Ronzio, 40, the company’s national sales director.
Federal investigators have been working on the case for two years, a job that included interviewing victims and families.
“In many ways I have been frustrated with how long it’s taken,” Ortiz said today. “We wanted to make sure we got it right. We wanted to be thorough and careful and not rush to judgment.”
The 73-page indictment describes in detail the alleged derelictions behind the outbreak, including a repeated failure to use an autoclave for the time needed to complete sterilization. The charges also relate to a series of cash withdrawals, totaling more than $33 million, intended to get around a bankruptcy court order barring movement of the company’s assets in the years after the outbreak.
The other defendants are Christopher Leary, 30; Joseph Evanosky, 42; Scott Connolly, 42; Sharon Carter, 50; Alla Stepanets, 34; Kathy Chin, 42; Michelle Thomas, 31; and Douglas Conigliaro, 53.
Svirskiy, Carter and Connolly pleaded not guilty at hearings in Boston today.
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