In a class action filed Thursday in U.S. District Court, Barbe Puro of Shakopee, Minn., claimed she developed symptoms of meningitis after receiving a spinal injection of methylprednisolone acetate tainted with fungus.
The drug, a steroid used to treat back and joint pain, was made by the New England Compounding Center in Framingham, Mass. Fifty sealed vials of the drug, obtained by the U.S. Food and Drug Administration, were found to contain fungus. The company has recalled all its products and shut down operations.
Calls to the compounding pharmacy were not immediately returned, and its website is down.
Puro is one of roughly 14,000 people believed to have been exposed to the suspect steroid. The U.S. Centers for Disease Control and Prevention confirmed that 185 people in 12 states have contracted fungal meningitis after spinal injections of the steroid. One person has contracted a joint infection after receiving an injection for ankle pain.
For a map of cases by state, click here.
Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients. The "potentially contaminated injections were given starting May 21, 2012," according to the CDC.
Puro claimed she received a spinal steroid injection Sept. 17 and developed headaches and nausea -- subtle symptoms of fungal meningitis. The following week, she received a call from the clinic that administered the shot, saying she might be at risk for fungal meningitis. The results of her spinal tap, a diagnostic test for meningitis, are pending, according to the lawsuit.
Puro filed the class action on behalf of all patients in Minnesota who received the recalled steroid. So far, the state has three known cases of infection and no reported deaths. Infections have also been reported in Tennessee, Michigan, Virginia, Indiana, Maryland, Florida, North Carolina, Ohio, New Jersey, Idaho and, most recently, Texas.
For a full list of clinics receiving the recalled lots of spinal steroid injections, click here.
Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, redness or swelling at the injection site can take more than a month to appear.
The longest duration from the time of injection to the onset of symptoms in the current outbreak is 42 days, according to the CDC's Dr. Benjamin Park.
"But we want to emphasize that we don't know what the longest will be," he said, adding that patients who received injections of the recalled drug should stay attuned to the subtle symptoms "for months."
Meningitis Outbreak: Pharmacy Under Fire
Fungal meningitis is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.
People affected by the current outbreak are being treated with two different types of antifungal medications until the type of fungus causing the infection -- aspergillus or exserohilum -- can be identified.
"These drugs are very strong and can be very difficult for patients to tolerate over time," said Dr. J. Todd Weber, incident manager of the Multistate Meningitis Outbreak at the CDC. He said the agency was working with experts on the dose and duration of the treatments.
The CDC has confirmed one case of aspergillus meningitis and 10 cases of exserohilum meningitis. It's unclear how the fungi landed in the steroid vials.
Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.
Puro claims the New England Compounding Center "was negligent because it failed to use reasonable care when it designed, tested, manufactured, marketed and sold doses of methylprednisolone acetate," and that she and others who received the recalled drug have "suffered serious bodily harm, other personal injuries and emotional distress, and have incurred medical and other expenses." She is seeking compensation for damages, attorney fees and other costs.