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Woman sues over meningitis outbreak

From Tina Burnside, CNN

(CNN) – A Minnesota woman is suing a Massachusetts pharmaceutical company at the center of the deadly meningitis outbreak.

The lawsuit filed Thursday in Minnesota federal court may be the first one in the recent outbreak.

In the suit, Barbe Puro alleges that in September, she was injected with a tainted batch of steroids from the Massachusetts-based New England Compounding Center.

There have been 184 cases of noncontagious fungal meningitis in 12 states, the Centers for Disease Control and Prevention said.

Fourteen people have died, and the cases have been linked to the steroid injections made by the Massachusetts facility, the CDC has said.

Some 14,000 people may have received the injections.

Puro was informed that she received the tainted injections and should see a doctor, the suit alleges.

She “underwent medical testing including blood work and laboratories, a spinal tap,” the suit says.

It is unclear what the results of those tests were.

Puro is seeking unspecified compensation and pushing for class-action status to cover others.

Meanwhile, members of Congress on Friday expanded an investigation into the outbreak.

In a letter to the director of the Massachusetts Board of Registration in Pharmacy, leaders of the House Committee on Energy and Commerce noted the Food and Drug Administration sent the NECC a warning letter in 2006 “detailing significant violations witnessed” by investigators the previous year.

“Included in the list of violations was the NECC’s manipulation of a sterile injectable product, which caused FDA to be concerned about potential microbial contamination,” the letter said. Also, “this particular inspection called into question whether the NECC was operating as a traditional compounding pharmacy or a drug manufacturer that produced, marketed and distributed drug products, not linked to prescriptions for identified patients, on a commercial scale.”

The committee is investigating whether “remedial measures” were taken after the inspection, “and why the NECC was able to continue operating in this manner more than six years after the fact,” the letter said.

On Wednesday, Massachusetts Gov. Deval Patrick accused the NECC of misleading regulators and operating outside its license by shipping large batches of drugs nationwide. Also Wednesday, the state’s pharmacy board took the step of requiring all Massachusetts compounding pharmacies to sign affidavits stating they are complying with state regulations requiring compounders to mix medications for specific patients.

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