Documentation on file at the FDA raises questions about why the government didn't do more when red flags were raised about the pharmacy in Massachusetts that is now suspected of causing an outbreak of fungal meningitis.
As of Thursday, 14 people across the country had died after receiving what officials say are tainted pain shots. Another 170 are sick.
Attorney Randy Kinnard's law firm represents 18 local families touched by the tragedy.
"Their injuries range from death, to paralysis from the waist down, to being in the ICU, to having a stiff neck and wondering if this is the beginning of the end," Kinnard said.
Meanwhile the investigation continues around the clock by the CDC, the FDA, and health officials in Massachusetts where the New England Compounding Center is located.
The FDA sent NECC a warning letter in December 2006. It tells the company to stop acting "like a drug manufacturer" instead of a pharmacy, which is how they are licensed.
Manufacturers have to follow stricter standards for producing drugs. Pharmacies are supposed to fill individual prescriptions.
At a news conference Thursday, the FDA admitted today there was little follow-up to that 2006 warning letter.
Massachusetts pharmacy regulators didn't re inspect NECC until five years later, when NECC indicated it planned to expand.
The company became so big, it was shipping large volumes of drugs all over the country; the Veterans Administration was one agency that bought in bulk from NECC.
FDA leaders and state regulators in Massachusetts didn't know that because they don't track volume.
NECC is expected to be named in a number of civil suits. The fact that the company seems to have ignored what the FDA told them to do six years earlier could hurt them in court.
"If you keep on doing something you've been told not to do, then you are subject to punitive damages, for recklessness or disregard for public safety. So hypothetically that could be a potential claim," Kinnard said.
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