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FDA seeks more authority amid meningitis outbreak

November 14, 2012 RSS Feed Print

Despite his silence, lawmakers repeatedly pressed Barry Cadden to account for the problems that led to the outbreak.

"Mr. Cadden, what explanation can you give the families who have lost their loved ones, and those who are gravely ill, for the actions of your company?" asked Stearns, who heads the subcommittee on oversight and investigations.

Flanked by two lawyers, Cadden told lawmakers, "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment."

Federal officials have opened a criminal investigation of Cadden and the NECC.

The Framingham, Mass.-based pharmacy has been closed since early last month, and Massachusetts officials have taken steps to permanently revoke its license.

Inspections last month found a host of potential contaminants at NECC's facility, including standing water, mold and water droplets. Compounded drugs are supposed to be prepared in temperature-controlled clean rooms to maintain sterility.

Cadden appeared immediately after the widow of a longtime Kentucky judge who died after receiving multiple doses of NECC's steroid injection.

Speaking without notes, Joyce Lovelace told lawmakers of more than 50 years of marriage to 78-year-old Eddie Lovelace, who was a circuit judge before his death on Sept. 17 at Vanderbilt University Medical Center.

"My family is bitter, we are angry, we are heartbroken and devastated. I come here begging you to do something about the matter," Lovelace said.

Health officials say as many as 14,000 people received the methylprednisolone acetate steroid shots, mostly for back pain. The Centers for Disease Control later showed that at least two lots of the injections distributed to 23 states were contaminated with fungus. The fungal meningitis outbreak was first discovered in September, though CDC officials say the earliest deaths connected to the outbreak date back to July.

Fungal meningitis causes inflammation of the lining of the brain and spinal cord.

Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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