October 12, 2012 — Yesterday, a woman from Minnesota filed the first fungal meningitis lawsuit in federal court. Barbe Puro, from Savage, Minnesota, received a steroid injection to treat neck pain. The injection she received was recalled by New England Compounding Center after products from the company were linked to a deadly outbreak of fungal meningitis. After she was contacted by the Minnesota Health Department, she underwent evaluation which included a spinal tap. She still suffers headaches and nausea and her future health is uncertain. She is seeking damages for her medical treatment, and also seeks to establish a class of injury victims in Minnesota.
Health Department officials have been contacting an estimated 950 Minnesotans who were exposed to the potentially tainted steroid shots. Most of these individuals have been contacted by now. The clinics that administered steroid shots include Medical Advanced Pain Specialists (Edina, Fridley, Shakopee, Maple Grove) and Minnesota Surgery Center (Edina, Maple Grove). Hundreds of people have been advised to undergo a medical evaluation, which may include a spinal tap if they are showing symptoms of fungal meningitis. Symptoms of the disease are often mild at first, and a spinal tap is the only way to conclusively diagnose the disease.
Although fungal meningitis is not contagious, the outbreak continues to grow because meningitis has an incubation period of several weeks or more. The nationwide outbreak has affected more than 170 people in 11 states, and caused at least 14 deaths.
The source of the outbreak has been traced to New England Compounding Center in Massachusetts. The company has issued a recall of all medicines produced at the facility. They are also facing civil and criminal investigations from the Massachusetts Attorney General’s office. Under Massachusetts state law, compounding pharmacies are only allowed to mix custom medications to fill specific prescriptions unless they obtain a special wholesaler’s license. The company is accused of mass-producing steroid shots and introducing them into interstate commerce.
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 Minnesota Pharmacy Board has also weighed in on the matter. Cody Wiberg, director of the Minnesota Pharmacy Board, said on October 10 that the New England Compounding Center was not licensed as a wholesale distributor in Minnesota. “It’s not acceptable to compound large batches and start selling it wholesale,” he said. In Minnesota, compounding pharmacies must obtain a special license to wholesale drugs.
The entire compounding pharmacy industry has received intense scrutiny this week, with several Congressional officials calling for increased oversight. Traditionally, compounding pharmacies were like small-scale, modern-day apothecaries. However, a growing number are mass-producing medicines at a fraction of the cost of major drug companies, and with far less oversight from the FDA.