14 from MA pharmacy charged in connection to deadly meningitis outbreak

18 Dec 2014 | Author: | No comments yet »

14 arrested for deadly meningitis outbreakIn the biggest criminal case ever brought in the U.S. over contaminated medicine, 14 former owners or employees of a Massachusetts pharmacy were arrested and expected to be charged Wednesday in connection with a 2012 meningitis outbreak that killed 64 people.

Months after their contaminated company was shuttered in the wake of dozens of deaths and hundreds of injuries, the New England Compounding Center’s majority shareholder and her husband moved more than $30 million in assets — even though a federal judge ordered them to freeze money transfers, according to prosecutors. The 131-count indictment brought against 14 people associated with the company alleges that the owners of NECC and a related company, Medical Sales Management Inc., deliberately misled federal and state regulators, while ignoring health and safety rules. 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 25 patients in seven states by ‘acting in wanton and willful disregard of the likelihood’ of death or great bodily harm. They are charged with 25 acts of second-degree murder under the Racketeer Influenced and Corrupt Organization Act (RICO), and face up to life in prison if convicted on all counts. The outbreak was caused by sloppy clean-room practices, including routine failure to properly sterilize drugs, according to the indictment unsealed Wednesday in Boston. “Production and profit were prioritized over safety,” U.S.

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 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.” The infections tied to the Framingham, Massachusetts-based company, also called NECC, led Congress almost a year ago to increase Food and Drug Administration oversight of compounding pharmacies, which provide health-care companies with tailored drug mixtures that aren’t commercially available.

In reaction to the outbreak, Congress last year increased federal oversight of so-called compounding pharmacies like NECC, which custom-mix medications in bulk and supply them directly to hospitals and doctors. ‘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.’ ‘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. 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. Boroff had put a clamp on those transactions as early as Jan. 28, 2013. “NECC seeks to forge a consensual, comprehensive resolution of these claims in the form of a … plan establishing a compensation fund for meningitis claimants based on agreements to be reached among them, the Company, its insurers and other parties with potential liability for the meningitis cases,” the company’s attorneys wrote in a Dec. 12, 2013, motion in bankruptcy court. “The company’s goal is to provide a greater, quicker, fairer and less expensive payout to its creditors than they could achieve through piecemeal litigation.” The committee representing creditors — those who NECC may owe money though bankruptcy litigation — raised “grave” concerns about a number of transfers made by the company before Boroff’s order. “[A]ll this goes to our grave concern that, based on past history … (the transfers) show a motivation to dissipate and remove assets and to deprive those assets of being available to pay injured parties, victims and creditors,” said David Molton, an attorney for the creditors, according to court transcripts from a Jan. 24, 2013 hearing. 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.

In an eerie moment while Ortiz was addressing the victims, Wednesday’s press conference was briefly interrupted when an official flanking her collapsed. Additionally, when mold and bacteria was detected in NECC’s clean room, senior pharmacists failed to stop production, investigate the source of contamination, or consult with a competent professional, as they were required to do.

NECC also approved the use of expired ingredients and concealed that it was doing so, the indictment alleges, sometimes using celebrity names on fake prescriptions to dispense drugs in bulk without being detected by FDA regulators. Following the meningitis outbreak’s discovery, NECC ceased operations and surrendered its license to the Massachusetts Board of Registration in Pharmacy. Robert Ronzio, the company’s national sales director, was also charged. “In many ways I have been frustrated with how long it’s taken,” Ortiz said Wednesday. “We wanted to make sure we got it right.

A licensed pharmacist who worked in Clean Room 1 and was supervising pharmacist in Clean Room 2, Svirskiy is accused, along with Cadden and other NECC employees, of knowingly using expired medicine during the manufacturing process and then falsifying records to hide that fact. With the knowledge of Cadden, Chin, and Svirskiy, the unlicensed Connolly allegedly made cardioplegia drugs for hospitals to use when they stopped a patient’s heart during surgery. A pharmacy technician and long-time NECC employee, Carter was director of operations for NECC in 2012, overseeing the processing, packaging, and shipping personnel.

Carter, along with others, allegedly convinced NECC clients to use fabricated individual prescriptions and to use fake patient names to avoid being regulated as a drugmaker.

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