October 12, 2012 — The first fungal meningitis lawsuit has been filed in federal court by a woman in Minnesota. She is seeking damages for her injuries and the creation of a statewide class of injured people. The woman, Barbe Puro of Savage, Minnesota, was injected with tainted steroid shots to ease pain in her neck. After she was contacted with health department officials, she underwent a painful spinal tap and medical treatment. She said she suffers headaches and nausea and her future health is uncertain.
Minnesota health department officials believe that about 950 Minnesota patients were injected with the recalled steroid shots. Health department officials are working to notify the individuals. Hundreds have been advised to have evaluations, because the symptoms of fungal meningitis are often very mild at first.
The Minnesota clinics that used the recalled medications include Medical Advanced Pain Specialists (Edina, Fridley, Shakopee, Maple Grove) and Minnesota Surgery Center (Edina, Maple Grove).
There are three confirmed cases of fungal meningitis in Minnesota. Nationwide, more than 170 people have fallen ill and 14 have died in 11 states. The non-contagious outbreak continues to grow because meningitis has an incubation period of several weeks, or sometimes months.
All of the people were injected with steroid shots, used to treat pain in the joints or back, from the New England Compounding Center. After the first case of fungal meningitis was traced to the company in September, they issued a recall of the steroid shots, and then recalled all of their medicines on October 5, 2012.
The company is facing accusations that they violated Massachusetts state law, which requires compounding pharmacies to only mix drugs after receiving a specific prescription. According to Dr. Madeleine Biondolillo, director of health care safety and quality at the Massachusetts Department of Health, “Certainly NECC was not operating, as far as the investigation has seen so far, in accordance with Massachusetts licensing regulation.” The Massachusetts state attorney’s office says they will be investigating potential civil or criminal penalties.
On Wednesday, October 10, the Minnesota Pharmacy Board director Cody Wiberg said that the New England Compounding Center was not licensed as a wholesale distributor or manufacturer of medicines — their Minnesota pharmacy license only allowed for filling individual prescriptions. “It’s not acceptable to compound large batches and start selling it wholesale,” he said. Minnesota law requires a specific license for out-of-state drug wholesalers to sell their product in the state.
Compounding pharmacies have come under scrutiny this week. Some of these modern-day apothecaries are mass-producing medicines and introducing them into interstate commerce — operating like miniature drug companies, but with far less government oversight. The FDA is not required to inspect compounding centers, and they are held to a lesser standard for proving drug safety than large pharmaceutical companies.