EG Man Indicted in Connection with Deadly Meningitis Outbreak Linked to Mass. Compounding Pharmacy

An East Greenwich man has been indicted on federal racketeering and racketeering conspiracy charges in connection with the nationwide fungal meningitis outbreak in 2012 that sickened 751 people and killed 64 because of tainted drugs produced at a Massachusetts compounding pharmacy.

A 131-count federal criminal indictment was unsealed today in Boston and it alleges that 14 people associated with New England Compounding Center in Framingham, Mass., conspired to produce and sell medicine in unsanitary conditions and without proper sterilization techniques to unsuspecting customers.

The indictment alleges that Scott M. Connolly, 42, of East Greenwich, worked without a pharmacy technician license at NECC beginning in or around March 2010 in a clean room filling cardioplegia drugs for hospital customers.

Connolly reportedly had voluntarily surrendered his pharmacy technician license in January of 2009 and to conceal his unlicensed status, used another defendant’s username and password when operating equipment.

Connolly’s unlicensed status was known to his supervisors, the indictment alleges.

Connolly lived in Brockton, Mass., when he worked for NECC.

Owner and head pharmacist Barry J. Cadden, along with supervisory pharmacist Glenn A. Chin were charged with 25 acts of second-degre murder in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia.

Eleven other individuals, all associated with NECC, including six other pharmacists, the director of operations, the national sales director, two of NECC’s owners, and one other individual were charged with additional crimes including racketeering, mail fraud, conspiracy, contempt, structuring, and violations of the Food, Drug and Cosmetic Act.

The 25 second-degree murders are included in the indictment as predicate racketeering acts under the Racketeer Influenced and Corrupt Organizations Act (RICO).

These charges relate to patients who received injections of preservative-free methylpredisolone acetate, or MPA, produced by NECC and died.

According to the indictment, Cadden and Chin knew that NECC was making MPA in a manner and in an environment in which they could not assure that the drug was sterile, yet the company touted itself as using extensive safety measures.

Despite knowing that they were making the MPA in an unsafe manner and in unsanitary conditions, Cadden and Chin nonetheless allegedly directed and authorized the shipping of MPA to NECC customers nationwide. It is alleged that Cadden and Chin were aware that doctors would inject MPA into their patients’ bodies, and that if the MPA was not in fact sterile, it could kill them.

The 25 murder racketeering acts comprise only a portion of the broad racketeering scheme charged in the indictment. The indictment also alleges that NECC’s other pharmacists knowingly made and sold numerous drugs in a similar unsafe manner.

The unsafe manner alleged in the indictment includes, among other things, the pharmacists’ failure to properly sterilize NECC’s drugs, failure to properly test NECC’s drugs for sterility, and failure to wait for test results before sending the drugs to customers. The insanitary conditions alleged in the indictment include, among other things, NECC’s lack of proper cleaning and NECC’s failure to take any action when its own environmental monitoring repeatedly detected mold and bacteria within NECC’s clean room suite of rooms throughout 2012.

It is further alleged that NECC repeatedly took steps to shield its operations from regulatory oversight by the FDA by claiming to be a pharmacy dispensing drugs pursuant to valid, patient-specific prescriptions. In fact, NECC routinely dispensed drugs in bulk without valid prescriptions. The indictment alleges that NECC even used fictional and celebrity names on fake prescriptions to dispense drugs, like Hugh Jass, Chris Rock, Robert Redford and both Steven and Billy Baldwin.

Finally, the indictment charges Carla Conigliaro, the majority shareholder of NECC, and her husband Douglas Conigliaro with transferring assets following the fungal meningitis outbreak. Specifically, the indictment charges that after NECC declared bankruptcy, and the bankruptcy court ordered the shareholders not to transfer assets, Carla and Doug Conigliaro transferred approximately $33.3 million to eight different bank accounts opened after the NECC bankruptcy.

Cadden and Chin face a maximum of up to life in prison if convicted on all counts.

Federal prosecutors said people working at NECC were callous and acted in total disregard of human life.

“As alleged in the indictment, 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,” said Attorney General Eric Holder. “With the indictment and these arrests, the Department of Justice is taking decisive action to hold these individuals accountable for their alleged participation in grievous wrongdoing. Actions like the ones alleged in this case display not only a reckless disregard for health and safety regulations, but also an extreme and appalling indifference to human life. American consumers have a right to know that their medications are safe to use, and this case proves that the Department of Justice will always stand resolute to ensure that right, to protect the American people, and to hold wrongdoers accountable to the fullest extent of the law.”

“Two years after the fungal meningitis outbreak, our hearts continue to go out to the victims of this tragedy and to their families,” said FDA Commissioner Margaret A. Hamburg M.D. “Our work on behalf of all patients who want and deserve medicines that do not subject them to undue risk is far from done. The FDA will continue to work aggressively on many fronts with the states, the Department of Justice, and others to protect the American public from unsafe compounded drug products.”

The 14 individuals charged in the indictment are Barry J. Cadden, 48, of Wrentham, Massachusetts; Glenn A. Chin, 46, of Canton, Massachusetts; Gene Svirskiy, 33, of Ashland, Massachusetts; Christopher M. Leary, 30, of Shrewsbury, Massachusetts; Joseph M. Evanosky, 42, of Westford, Massachusetts; Scott M. Connolly, 42, of East Greenwich, Rhode Island; Sharon P. Carter, 50, of Hopkinton, Massachusetts; Alla V. Stepanets, 34, of Framingham, Massachusetts; Gregory A. Conigliaro, 49 of Southborough, Massachusetts; Robert A. Ronzio, 40, of North Providence, Rhode Island; Kathy Chin, 42, of Canton, Massachusetts; Michelle Thomas, 31 of Cumberland, Rhode Island; Carla Conigliaro, 51, of Dedham, Massachusetts and Douglas A. Conigliaro, 53, of Dedham, Massachusetts.