First Lawsuit Filed Against New England Compounding Center Amid Mounting Criticism

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A Minnesota woman who received contaminated steroid injections linked to a nationwide meningitis outbreak has filed a federal lawsuit against the compounding pharmacy that produced the shots.

CBS Minnesota reports Barbe Puro, of Savage, Minn. received steroid injections sold by the New England Compounding Center, which recalled all vials of the medicine -- and all its other products off the market -- after government health officials traced an outbreak of fungal meningitis to three contaminated lots of injections. Puro reportedly was treated with the injections to ease pain in her neck and had been contacted by state health officials and informed of her risk.

She received medical treatment and a painful spinal tap, according to CBS Minnesota, and her health status is uncertain.

New CDC data show there are 170 reported meningitis infections tied to the 11-state outbreak which has killed 14 people.

In total, up to 14,000 people may have received the contaminated injections, said officials at an Oct. 11 press conference; previous estimates suggested that number was closer to 13,000 patients. The CDC reported nearly 12,000 of these patients -- about 90 percent - have been tracked down and told about their risk.

While many of the patients who developed meningitis received epidural steroid injections for back pain, health officials noted Thursday people received the injections in other areas of the body, including joints such as the knee and ankle.

The CDC reported on one patient who may have developed a fungal infection in his or her ankle following injections of the contaminated steroid.

The New England Compounding Center, or NECC, shipped more those 17,000 vials of the drug blamed for the outbreak to 23 states.

States that received injections include: California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas and West Virginia.

During Thursday's press conference, Dr. Madeleine Biondolillo, director of health care safety and quality at the Massachusetts Department of Public Health, told reporters that the company violated Mass. state law that requires compounding companies to only mix drugs after receiving a patient's specific prescription, and instead mass-produced compounded drugs.

"Certainly NECC was not operating, as far as the investigation has seen so far, in accordance with the Massachusetts licensing regulation," she said.

"Our intent has always been to comply with all regulations, and cooperate with all regulatory agencies," the NECC said in an emailed statement to the CBS Evening News.

CBS Evening News medical correspondent Dr. Jon LaPook reported on Thursday that government health officials acknowledge there is a regulatory gap when it comes to compounding pharmacies.

Biondolillo noted Massachusetts does not have the authority to track how many vials of medication a compounding company distributed, and that interstate distribution from these companies needs to be regulated at a federal level. The Food and Drug Administration said it lacks clear authority to examine a compounding pharmacy's records.

"The FDA has worked very hard over the last several years to try to promulgate regulations to clearly define when does a compounding pharmacy exceed its authority and become a manufacturer under the purview of the FDA," Pharmacist Eric Kastango, who served on a panel creating federal standards for the compounding pharmacy industry, told the CBS Evening News in defense of the FDA.